NO851492L - ELECTROMAGNETIC APPLIANCE FOR EXTERNAL TREATMENT OF BODY PARTS - Google Patents

Description

This invention relates to the treatment of living tissue and/or cells by changing their interaction with the charged species in their environment. In particular, the invention relates to a controlled modification of cell and/or tissue growth, repair and maintenance behavior by applying modified electrical information. Even more particularly, this invention provides the application of a surgically non-invasive, direct inductive coupling of one or more electrical voltages and accompanying current signals that follow a highly specific pattern.

Several attempts have previously been made to make living tissue respond to electrical signals.

Investigations have been carried out involving the use of direct current, alternating current and pulsating signals of single or double polarity. Interventional treatments involving the use of implanted electrodes have been followed, as well as non-interventional techniques using electrostatic and electromagnetic fields. Much of the previous work that has been carried out is described in volume 238 of the Annals of the New York Academy of Sciences published on 11 October 1974 with the title "Electrically Mediated Growth Mechanisms in Living Systems"

(A.R. Liboff and R.A. Rinaldi). See also "Augmentation of Bone Repair by Inductively Coupled Electromagnetic Fields" by Andrew L. Bassett, Robert J. Pawluk and Arthur A. Pilla, published in Volume 184, pages 575 - 577 of Science (May 3, 1974).

The present invention is based on fundamental cell studies and analyzes which entail a detailed consideration of mutual influences of charged species, such as bivalent cations and hormones at a cell's interfaces and connections.

Fundamentally, it has been established that by changing the electrical and/or electrochemical environment around a living cell and/or a tissue, a modification can be achieved, of-

have a beneficial therapeutic effect of growth, repair

and the maintenance behavior of the same tissue and/or cells. This modification or effect is carried out by exposing the desired surface of tissue and/or cells to a specifically coded electrical voltage and accompanying current, through which the mutual effects

nings of charged species at the cell surfaces are modified. Such modifications create a change in the state or function of the cell or tissue which can result in a beneficial influence on the treated site. E.g. is it possible in the specific case of bone growth or repair to change with an electrical code, hereinafter denoted

2+

Mode 1, the interaction of an ion such as Ca with a cell's membranes. With another electrical code, in the following termed Mode 2, a modification in the same cell's protein synthesis capabilities can be achieved.

E.g. tissue culture experiments including the study of embryonic chicken limb rudiments show that the use of a Mode 1 signal produces elevated Ca 2+ release by up to 50% from the competent osteogenic cell. This effect is highly specific to the parameters of the electrical code for Mode 1. Thus, this code affects a leading step in ossification, i.e. the mineralization of a bone growth site. Similar tissue culture studies using signals from Mode 2 have demonstrated that this code is responsible for increased protein production from similarly competent osteogenic cells. This last effect is also highly specific to the parameters of the electrical code of Mode 2. In other words, this code affects certain metabolic processes of these cell types, such as those involved in the uptake or release of calcium from the mito-chrondria as well as the synthesis of collagen, a fundamental structural protein in bone substance.

These studies show that the electrical codes of Mode 1 and Mode 2 evoke individual tissue or cell responses, suggesting that each code contains highly specific information. Based on these and other studies, it has been possible to use Mode 1 or Mode 2 signals or a particular combination of Mode 1 and Mode 2 signals to achieve a specific response desired to enable the functional healing of a defect in a leg. These electrical modes have been adapted successfully in human and animal patients for non-ligated fractures such as congenital pseudoarthrosis and non-unions as well as healthy fractures. Good results obtained in cases of congenital pseudoarthrosis are particularly remarkable, since usually 80% of children with such disorders require amputation, because conventional treatment methods such as bone grafting and internal fixation are not successful.

While many investigations have been made to date of the response of living tissue and/or cells to electrical signals, the clinical results using previous methods have not been uniformly successful to date or generally accepted within the associated professional circle. Several reasons contribute to this. Firstly, it has not yet been realized that electrical signals with very specific information content are required to achieve a specifically desired beneficial clinical effect on tissue and/or cells. Second, most previous methods used implanted electrodes, which, thanks to unavoidable faradaic (electrolysis) effects, are often more toxic than beneficial at the treated site. Furthermore, the cells and/or tissues are exposed to a highly uncontrolled current and/or voltage distribution, whereby the cells' ability to respond is made difficult if they were to respond to the applied signal. This highly uncontrolled current and/or voltage distribution also occurs in the case of capacitively coupled signals.

In contrast, the non-surgical, direct inductive coupling of electrical information content of specific electrical codes, such as in the present invention, produces a controlled response in the living tissue and/or cells.

Briefly, the present invention includes the recognition that growth, repair and maintenance behavior of living tissue and/or cells can be usefully modified by applying specific electrical information. This is achieved by applying pulse waveforms of voltage and accompanying current with a specific time-frequency-amplitude relationship to tissue and/or cells by a surgical non-invasive method using a varying electromagnetic field that is coupled inductively by direct induction to or on the tissue and/or the cells under treatment. This information supplied to the cells and/or tissue through these signals is intended to influence the behavior of non-excitable cells, such as those involved in tissue growth, repair and maintenance. These growth, repair, and maintenance phenomena are significantly different from those involved in excitable cell activity (eg, nerves, muscles, etc.) particularly with respect to the type of perturbation required. Thus, the voltages and accompanying currents applied to the cells and/or tissue are at least three orders of magnitude lower than those needed to produce cell activities such as cardiac pacing, bladder control, etc.

The invention will be better understood from the following detailed description in connection with the attached drawings, where Fig. 1 is a simplified image showing the treatment of a leg according to the invention; Fig. 2 shows the treatment unit from fig. 1 in perspective;

Fig. 3 is a view (rear view) of the device shown

in fig. 2, showing the location of a coil therein used for treatment purposes;

Fig. 4 is a schematic diagram of an electrical system which will provide energy to the coil shown in fig. 3 for Mode 1 treatment; Fig. 5 is a schematic diagram of an electrical system which will provide energy to the coil shown in fig. 3 for Mode 2 treatment.; Figures 5a and 5b are pulse waveform diagrams for Mode 1 and Mode 2 treatments respectively, showing the currently preferred pulses as induced in living tissue and cells; Fig. 6 shows alternative forms of negative pulse parts for Mode 2 processing; Fig. 7 shows a unit for body treatment seen from the front which is a design to replace the one in fig. 1. It is shown unfolded, ready to be tied around a diseased part of the body; Fig. 7a is a section taken at 7A - 7A in fig. 7; Fig. 8 is a perspective view of a locating element for use with the apparatus of Fig. 7; Fig. 9 is a schematically simplified picture of a method for using the device and the element in fig. 7 and 8; Fig. 10 is a simplified cross-section through a body part model to which the apparatus and element in fig. 7 and 8 are attached; Figures 11 and 12 are simplified perspective views showing apparatus for body treatment for special purposes; Fig. 13 is a diagram illustrating discussion of coil placement considerations; Figures 14, 15 and 16 are similar pairs of images a and b respectively, representing schematic front and side views of each of the three different generally elliptical shapes of coil pairs; and Fig. 17 - 20 are pictures similar to fig. 11 and 12 to show coil devices for additional body treatment apparatus.

Reference is made to fig. 1-3 where the leg 10 of a person with a broken leg, as indicated at 12, is shown as being representative of the application of the invention to the stimulation of bone growth for healing purposes. A treatment head is placed on the outside of the person's skin and is held in place using a strap 16 (attached to the head 14 with fasteners 16a) which may include Velcro material 18 so that the strap can be wrapped around the leg and the treatment head to . keep the treatment head in place against the leg. The treatment head 14 may include a foam material 20 on its inner surface for the purpose of cushioning and ventilating the treatment head against the leg. It will be seen that the treatment head 14 is usually curved on its inner surface so that it fits the shape of the leg being treated.

The treatment head 14 includes a coil 22 which can have

v

any suitable form. As shown in fig. 3, the coil is usually rectangular so that a "window" is formed within the inner part of the loops of the coil. The coil 22 may lie in a plane or may generally be curved so that it fits the curvature of the treatment head 14. The winding 22 comprises poles 24 which protrude from the treatment head 14 to be connected to a

cable 26 for connection to a suitable energizing circuit which will be explained in more detail below. A diode 27

can be included in the cable 26 for connection over coil 22, which will also be explained below.

The treatment head 14 is placed on the patient so that the "window" formed by the winding 22 is close to the fracture 12, i.e. close to the tissue being treated. Current is applied to the winding 22 as described in more detail below and induces an electrical voltage within the tissue being treated. It has been found that a special type of signal should be induced in the tissue, and this is achieved by passing the coil 22 from a circuit as shown in fig. 4 or 5 to produce the pulse signal shown in fig. 5a or 5b.

According to fig. 4, a variable direct current supply 30 is connected through a port 32 to the processing coil 22 (or coils, as the case may be, and this will be explained in more detail below). The gate 32 is under the control of control units 34 and 36 which cause a pulse signal consisting of repeated pulses of electrical voltage to be supplied to the processing coil 22. Each pulse is, as shown in fig. 5a composed of a "positive" pulse part P1 followed by a "negative" pulse part P2 due to the stored energy inside the treatment coil. In the circuit in fig. 4, a diode lock unit 38 can be used to limit the peak voltage of the negative pulse part. The diode lock unit 38 can be one or more diodes connected across the coil 22 and can advantageously be placed inside cable 26. The diode 27 shown in fig. 1 constitutes such a locking unit 38.

In fig. 5a shows the signals at the treatment coil 22 and thus the induced signal in the tissue to be treated. At time t, it is assumed that gate 32 is activated by a suitable signal from the control unit 36 (designated pulse width control unit) so that the electrical voltage across the treatment coil 22 is increased from approx. 0 volts along the pulse segment 39 to a voltage denoted v^in fig. 5a. The signal across the treatment coil decreases in another pulse segment along the part of the curve denoted by 40 in fig. 5a. The slope of this curve is determined by the L/R time constant of the circuit in fig. 4, i.e. the inductance of the treatment coil and the effective resistance of the circuit, including distributed factors of capacitance, inductance and resistance. For the treatment of many tissues and cells, it is considered desirable to adjust the circuit parameters so that the part 40 of the curve is as flat as possible, which makes the signal given to the treatment coil 22 as rectangular in shape as possible. At time t2, gate 32 is switched out of the control unit 36. Just before it is switched out, the signal over the processing coil at a voltage V2 is shown in fig. 5a. The voltage across the treatment coil drops from the level V2 in a third pulse segment 41 to a voltage of the opposite polarity designated v^ in fig. 5a. The magnitude of the voltage V 3 with the opposite polarity can be limited by the diode blocking unit 38 to a relatively low value compared to the value v . The signal across the processing coil 22 then decreases from voltage level v^ to zero or reference voltage level, and finally reaches the level at time t^. A predetermined period elapses before the pulse repetition rate s tree unit 34 produces an appropriate timing signal which initiates the controller 36 to produce a signal to re-engage gate 32 to continue the cycle just explained.

The control units can typically be monostable multivibrators, e.g. to produce suitable time signals, and which can be variable to control the pulse duration and repetition rate within the desired limits. Furthermore, the use of a variable direct current source 30 allows variation of the amplitude of the pulse signal as desired.

When pulse train operation (Mode 2) is used, an additional timer circuit similar to units 34 and 36 in fig.

4 to produce width of the series segment and repetition rate of the series segment. If we look at fig. 5: The control units 35 and 37 control port 33 to produce a waveform type signal to coil 22 as shown in fig. 5b. Otherwise, the circuit is the same as in fig. 4 with the exception that the diode latch unit 38 is omitted to allow for the large negative pulse portions as shown in FIG. 5b. The control units 35 and 37 determine the number of pulses in a series and the time between successive series.

It has been found that the signal over the treatment coil 22 and thus the induced signal in the tissue during treatment must satisfy certain criteria. These criteria will be specified with respect to the signal induced in the tissue and/or cells under treatment. Such an induced signal can be monitored if desired, by using a "pick-up" coil to help (not shown in the drawing) which is placed at a distance from the treatment coil 22 corresponding to the distance of the tissue under treatment from this coil, as will be explained further detailed below. In any case, it has been found that the following criteria must be met for effective treatment of living tissue and cells, especially for hard tissue such as bone substance.

In the following representation, the signals shown in fig. 5a and 5b the pulses of electrical voltage and accompanying current developed by the coil and applied to the tissues and/or cells. These pulses have a polarity when the coil is supplied with energy (hereinafter referred to as the "positive" part of the pulse and shown as the positive-going part of the waveform in Figs. 5a and 5b). These pulses have an opposite polarity when the energy is removed from the coil (hereafter referred to as the "negative" part of the pulse and shown as the negative going part of the waveforms in Figs. 5a and 5b. The designations "positive" and "negative" shall only be relative and is used here only for the purpose of indicating that pulse parts of opposite polarity with respect to a reference voltage level are involved.

It has been determined that the "positive" pulse parts should be in a predetermined relationship with the "negative" pulse parts in order to modify the behavior of living tissues and cells in a useful way and with uniform results. This predetermined ratio has been achieved by using two different signal modes as well as combinations thereof.

In Mode 1 (fig. 5a), the asymmetric waveform is induced in tissue or cells by alternating power supply and de-energisation of an electromagnetic coil repeated with such a frequency that the total duty cycle is not less than 2%. In Mode 1, this frequency has typically been approx. 10 - 100 Hz with duty cycles of 20 - 30%. The fundamental relationship for Mode 1 to the respective frequency amplitude content of the "positive" and "negative" pulse parts is as follows: the pulse signal must have a specific form, namely each "positive" pulse part must consist of at least three segments, e.g. segments 39, 40 and 41 in fig. 5a. As noted above, a substantially rectangular shaped "positive" pulse signal portion has been found to be particularly useful in the treatment of tissues and cells. However, it is possible that other pulse shapes (other than simple 2-segment tip) may be useful. The maximum amplitude of the last segment of each "positive" pulse part, e.g. the voltage v 2 in fig. 5a should not be less than 25% of the maximum amplitude of the first segment 39 of the "positive" pulse part, e.g. the voltage Vj, in fig. 5a.

The maximum amplitude of the "negative" part is denoted by V3 in fig. 5a. This maximum amplitude should not be more than approx. 1/3 of the maximum amplitude of the "positive" pulse part. The duration of each "positive" pulse part in time (the time that elapses between times t^ and ii^ in Fig. 5a) should not be longer than approx. 1/9 of the duration of the subsequent "negative" pulse part (the time that elapses between the times t.^ and in Fig. 5a). Because the treatment system uses an electromagnetic coil, the energy of each "positive" pulse part is equal to the energy of each "negative" pulse part, i.e. the area in fig. 5a which is covered by the "positive" pulse parts is equal to the area covered by the "negative" pulse parts. By satisfying the just-mentioned criteria, the energy of each "negative" pulse part is spread over a relatively long period of time, and the average amplitude of the negative pulse part is limited. It has been found that such average negative amplitude should not be greater than 1/6 of the average amplitude of the "positive" pulse part.

These conditions also ensure that the "positive" and "negative" pulse parts have the correct frequency amplitude characteristics in themselves and in relation to each other so that a beneficial modification of the behavior of tissues and cells is achieved.

In addition to the relationships mentioned above, it has been found that the average size of the "positive" pulse part's peak voltage should be in the range of approx. 0.0001 to 0.01 volts per cm of tissue or cells, corresponding to between 0.1 and 10 microamps per cm 2 treated tissue or cells (based on typical specific resistance of cell and tissue). Higher or lower pulse voltages have been found to have no real effect. It has also been found that each "positive" pulse part (the time elapsing between times t^ and t2 in Fig. 5a) should be at least approx. 200 microseconds. If the duration of each "positive" pulse part is less than approx. 200 microseconds, the tissues and cells are not stimulated enough to modify the repair or other processes. From a practical point of view, the duration of the "positive" pulse part should not be greater than approx. 1 ms. It has also been found that the repetition rate of the pulses should be within the range of 65 - 75 Hz for bones and other hard tissues. Pulse treatments in this area have been found to be particularly effective with repeatable results for tissues and cells of this type. In general, however, the pulse repetition rate should be between 10 and 100 Hz for good results in tissues and cells.

For the treatment of bone disorders, and particularly for the treatment of pseudoarthrosis, it has been found that for Mode 1, an optimally induced "positive" pulse signal portion with a peak amplitude of between 1 and 3 millivolts per cm treated tissue (1-3 microcampers per cm 2 treated tissue and/or cells) with the duration of each "positive" pulse part around 300 jus and the duration of each of the "negative" pulse parts approx. 3300 as well as a pulse repetition rate of approx. 72 Hz represents a currently preferred and optimal induced pulse treatment provided that the requirements for pulse shape as described above are met. The total processing times may vary. Currently, it is believed that pulse signal treatments during periods of at least 15 minutes with one or more treatment periods during a prescribed number of days can be effective in stimulating tissue and cell behaviour. A preferred treatment program using Mode 1 has been found to be a minimum of 8 hours per day over a period of four months in difficult cases, and two weeks in less difficult cases.

In Mode 2 treatment (Fig. 5b), the asymmetric waveform induced in tissue or cells is applied through alternating power supply and de-energization of an electromagnetic coil in a pulse train modality comprising pulse series of asymmetric waveforms. Each series of asymmetric pulses has such a duration that the duty cycle of the series part is not less than 1%. The frequency of the series has typically been approx. 5 - 50 Hz.

The fundamental relations for Mode 2 of the respective frequency-amplitude contents of the "positive" and "negative" pulses within the serial section of the pulse train are as follows: each "positive" pulse part should consist of at least three segments, e.g. segments 39', 40' and 41' in fig. 5b. For this mode, a substantially rectangular "positive" pulse signal portion has also been found to be particularly useful in the treatment of tissues and cells. However, it is possible that pulse shapes other than a simple two-segment spike may be useful. The Tcpp amplitude at the last segment of each "positive" pulse part, e.g. the voltage v2 in fig. 5b, must not be less than approx. 25% of the peak amplitude of the first segment 39' of the "positive" pulse part, e.g. voltage v^in fig. 5b.

The "negative" peak amplitude is denoted by v^ in fig. 5b. This "negative" peak amplitude should not be more than approx. 40 times the "positive" peak amplitude (in this case v^). This requirement can be met by using "negative" pulse parts with several different waveforms, e.g. substantially rectangular, trapezoidal with exponential decay, bell-shaped, or single-claw with exponential decay as in the representative waveforms a, b, c and d in Figs. 6.

The duration of each "positive" pulse part (the time that elapses between times t^ and t2 in Fig. 5b) should be at least approx. 4 times the duration of the subsequent "negative" pulse part (the time that elapses between the times t2 and t^ in fig. 5b). Since, as mentioned above, the processing system uses an electromagnetic coil, the energy in each "positive" pulse part is equal to the energy in each "negative" pulse part, i.e. the flat in fig. 5b, which is covered by the "positive" pulse parts, is equal to the flat area covered by the "negative" pulse parts.

The pulse frequency within the series segment of the Mode 2 series (the time that elapses between times t^ and t^) can be approx. 2000 Hz and 10,000 Hz.

The width of the series segment of the pulse train (the time elapsed between t^ and t^) should be at least approx. 1 " of the time that elapses between t^and tg.

By satisfying the criteria just mentioned, these5 conditions also ensure that "positive" and "negative" pulse parts have the correct frequency/amplitude characteristics within themselves and with each other, so that a beneficial modification of the behavior of tissues and cells is achieved.

In addition to the aforementioned relationships, it has also been found that the average size of the "positive" peak voltage should lie within the range 0.00001 - 0.01 volt per cm of tissue and/or cells (between approx. 0.01 and 10 microamps per cm 2 of treated tissue and/or cells).

It has been found that higher or lower pulse voltage

i nings will not result in a beneficial effect on tissues and/or cells. It has also been found that the duration of each "positive" pulse part in the series segment of the pulse train (ie the time elapsed between t^ and t_ in Fig. 5b) should be at least approx.

1000 . It has also been found that the repetition rate of the series segment should be within the range of 1 - 15 Hz for bone or other hard tissues.

Each negative pulse part within the serial segment of the pulse train should have a duration no greater than approx. 50 j^- s and an average amplitude no greater than approx. 50 mv/cm of treated tissue and/or cells (approx. 50 microamps per cm<2> of treated tissue and/or cells.

For the treatment of bone disorders and particularly for the treatment of pseudoarthrosis and non-unions, it has been found that an optimally induced "positive" pulse signal portion with a peak amplitude of between 1 and 3 millivolts/cm of treated tissue (ie 1-3 microamps per cm 2 treated tissue and/or cells) with a duration of each "positive" pulse part of around 200 ps and a duration of each of the "negative" pulse parts of around 30/as and a time course between the times t^ and t^ in fig. 5b of 10 yWs and a pulse repetition rate of approx. 4000 Hz and a

series segment width of approx. 5 ms as well as a serial repetition rate of approx. 10 Hz represents a currently preferred one

and optimal induced pulse treatment in legs for Mode 2, provided the above-mentioned pulse conditions are met.

It is also believed that a simple asymmetric pulse as described in the series segment of Mode 2 can be used at a repetition rate similar to that used in Mode 1 for beneficial modification of tissue growth and repair.

Treatment of living tissue and cells according to the methods described above, especially for hard tissue such as bone,

have shown an increasing repair response and usually uniform results are achieved in all patient and animal treatments. Particularly beneficial results have been achieved in cases of treatment of pseudoarthrosis where union of bones has been achieved after previous fruitless attempts

according to other treatment methods, and where amputation has been done

in discussed as an alternative to regain functional capacity.

In practice, it is thought to be desirable to use as large a "coil window" as possible and to place the coil so that a

appropriate current density is imposed on the tissue and/or cells that are being treated. As is known, a time-varying magnetic field induces a time-varying voltage field at right angles to itself. That is the geometry of the magnetic field lines determines the geometry of the induced voltage field. Because

one wants a relatively uniform induced voltage field, the geometry of the magnetic field lines should be as uniform as possible, which can be achieved by making the size of the coil relatively large in relation to the area being treated. At this moment, they don't think there needs to be anyone

special orientation between the magnetic field lines and the tissue and/

) or the cell being processed.

It is believed that the uniformity of the induced voltage field that is possible with electromagnetic treatment is in many respects responsible for the good treatment results

which has been achieved in contrast to the non-uniform fields which can result, and which probably also result in other types of treatment, e.g. use of electrostatic fields or by the formation of a voltage drop when using electrodes implanted in or on tissues and cells. Especially is

an induced voltage field present in a vacuum as well as in an electrically conducting medium or an insulator. The field properties will usually be the same (within one percent) i

these three cases, except in the case where an induced current is sufficiently large to form an electromotive force to distort the magnetic field lines. This condition occurs when a conductive medium has high conductivity, e.g. a metal, and is large enough to intercept a substantial

number of magnetic lines. Living systems, i.e. tissues and/or

3 cells are much less conductors than a metal (usually at least by 10^, i.e. by five orders of magnitude). Because of these realizations, the geometry of the magnetic field present in tissues and/or cells is undisturbed and remains unchanged as the tissue and/or cell growth process continues. With non-intrusive electromagnetic treatment it is thus believed that the voltage drop produced inside the tissue and/or cells is constant regardless of the treatment's stage or conditions.

Such uniformity in the induced voltage is practically impossible to achieve when using implanted electrodes or by electrostatic coupling or with a transformer connected to electrodes or by implanted coils connected to electrodes. As the latter types of treatment are dependent

of conductivity which will vary within tissue and/or cells, the induced voltage drop will not be constant as the condition of the tissue and/or cells changes. In addition, at any particular time in tissue and/or in cells, individual locations of the material under treatment will have different conductivity properties, which will result in different voltage drops through the treated material.

For these reasons, it is believed that a surgical non-invasive electromagnetic treatment of tissues and/or cells

is far preferable to electrical treatment by other methods.

Regarding special parameters for the coil, it is believed that coil windows for typical bone fractures of approx. 2.0" x 2.75" (5x7cm) (for an adult) and 2" x 1.5" (5x3.8cm) (for a child) are appropriate.

The wire used in the coils may be Brown & Sharpe No. 12 copper wire coated with varnish to isolate the windings from each other. Coils with approx. 60 windings for an adult and 70 windings for a child seem to be appropriate. For treatment in the oral cavity, the coil size will be correspondingly smaller.

It is believed that the inductance of the treatment coil should be between 1 and 5000 microhenries, and preferably between approx. 1000 and 3000 microhenries with sufficiently low resistance (eg 10 to 1 ohm) and a high "input" coil crift signal between approx. 2 and 30 volts to induce the appropriate pulse voltage in the tissue and/or cells being treated. The smaller the inductance in the treatment coil, the steeper the slope of the curves 40 and 40' as shown in fig. 5a and 5b; The greater the inductance, the flatter or more rectangular the "positive" pulse produced.

The monitoring of the induced voltage can be done with real electrodes in contact with the tissue and/or the cells under treatment or by using a "pickup" coil placed close to the treatment coil 22 at a distance corresponding to the distance of the material under treatment from the coil. A typical "pickup" coil that has been used is circular, approx. 1/2 cm in diameter with approx. 67 - 68 wire windings. The voltage developed by the coil is divided by the length of the wire (in cm) to give a number of induced voltage per cm which is closely related to volts per cm induced in the tissue and/or cells during treatment.

A typical treatment using a coil with a "window" 5 x 7 cm and 60 turns of size 17 wire, comprising a diode at the coil such as diode 27 in FIG. 1 produced the following induced voltages in a pickup coil<+>^ for the pulse times (in s) as follows (voltages and times refer to the waveform in Fig. 5): +) These voltage values can be translated into millivolts per cm of tissue by dividing by a factor of the nearest 10.

The use of pulsed electromagnetic fields to control bone formation in various conditions is now on a solid experimental and clinical basis. So far, this development has found application in the successful treatment of congenital and acquired pseudoarthrosis and fresh fractures in humans, increasing the rate of healing of fractures and reactive periostitis in animals, as well as in reducing bone loss from osteoporosis in long disused bones. The good result of the method depends on the discovery of pulse patterns with specific time-frequency-amplitude relationships as outlined above.

EXAMPLES

To demonstrate the business, at the beginning the use of direct inductive coupling of electromagnetically induced pulsating voltages and accompanying current via Modes 1 and 2 as well as combinations of these for growth and tilting of hard tissue was used in cases of congenital and later developed pseudoarthrosis. In one group of patients, only individuals who had previously been treated with one or more surgical attempts (grafting, internal fixation) were considered. For most of these patients, amputation had been recommended by at least one qualified orthopedist. Through this study, the necessity of pulse specificity was illustrated again and again. E.g. when lack of ossification was the primary problem (usually the case with congenital pseudoarthrosis), Mode 1 treatment was used, and final functional bone connection only occurred when the pulse parameters corresponded to those given above. When, on the other hand, a lack of bone substance was the primary problem, Modus 2 treatment was used to achieve the production of collagen, which is the primary supporting protein in bone structure. Since protein production and ossification are two completely different steps in bone formation, the highly selective nature of each of the signals used in

Mode 1 and Mode 2 are combined synergistically when neither matrix production nor ossification was present in the treatment protocol of a given patient. Thus, a combination of Mode 1 and Mode 2 was used with advantage in situations of this type.

In the case of congenital pseudoarthrosis, the typical patient is between 1 and 10 years old. The affected part is usually the distal tibia of an extremity. The patients had on average three failed surgical treatments in the past and had the disease for an average of 5 years, and all were candidates for amputation.

The treatment of such a patient was usually carried out using Mode 1 treatment, since the primary problem was a lack of ossification in the diseased area.

The orthopedic surgeon prescribes appropriate equipment for the patient who carries out his treatment on an outpatient basis. Treatment time is typically 12 - 16 hours per day on average approx. 4 months.

So far, approx. 20 cases of this disorder have been treated, and successful ossification was achieved in close to 90% of the treated individuals.

For acquired pseudoarthrosis, either traumatic or operative, the patients were mostly adults and with an average of three failed operations and with an average of 2 1/2 years from the onset of nonunion. Amputation had been discussed for 70% of these individuals. Since the primary problem in some cases was a lack of bone matrix, typically visible radiographically as gaps in the bone larger than 2 mm at the fracture site, such a patient was treated first with the Modus 2 program. When it was believed that sufficient non-ossified bone matrix was present, the Mode 1 program was used to achieve rapid immobilization of the fracture site.

Due to the particular pathology of some patients in this group, a combination of Modes 1 and 2 was used, in which treatment in particular Mode 2 was followed by Mode 1. As in the case of congenital pseudoarthrosis, the correct equipment was prescribed by the attending orthopedic surgeon , and the treatment was carried out on an outpatient basis. Treatment time is typically 10 - 14 hours per 24/7 for periods of 3 to 9 months.

About. 30 cases of this type have been treated so far, and successful bone union observed in 75% of the treated individuals.

These clinical results clearly demonstrate that once the particular pathological nature of a bone disorder is diagnosed, it can be successfully treated selectively by making use of properly coded changes in the electrical environment.

Similar findings have been made from a study of bilateral femoral and radial osteotomies in 160 rats. These animals were divided into two larger groups, field subjects and control group for 14 days after surgery. After killing, the degree of fracture inclination was assessed on the basis of X-ray and histological assessment, combined with non-destructive mechanical testing. These experimental animals were used to assess the effectiveness of the treatment program of Modi 1 and 2, as well as combinations of these. Generally, when the osteotomy opening was less than 1 mm, a Mode 1 signal was effective, since very little bone matrix was needed for fixation. On the other hand, for wider osteotomies, significantly increased matrix production was observed in the control animals when Mode 2 was used.

A combination of Modes 1 and 2 was used in the latter case to achieve a stiffer slope site for an equivalent processing time.

This was further assessed by the response of these legs to mechanical testing. This was performed by subjecting the rats' legs, after killing, to cantilever loading at various deformations in accordance with experimental methods described in "Acceleration of Fracture Repair by Electromagnetic Fields. A Surgically Non-invasive Method" by C.A.L. Bassett, R.J. Pawluk and A.A. Pilla, published on pages 242 - 262 of the Annals of The New York Academy of Sciences referred to above. The test vein was deformed in antero-posterior, lateral-medial, postero-anterior, medial-lateral and again antero-posterior positions.

The average response of a femur to this specimen at a deformation of 0.05 inches (1.27 mm) is shown in Table I as follows:

In addition to radiographic and mechanical evidence of the effectiveness of the signal used, histological testimony further attests to this effectiveness.

Longitudinal samples stained with hemotoxylin and eosin show a much higher degree of maturation for Mode 1 than in the control case.

For wider osteotomy gaps, treatment times of 14 days showed that the active animals had significantly larger callus than the controls. The histological evidence shows that the increase is at least 150% over the controls.

Limited studies of tooth extraction have been carried out and show that pulses of Mode 1 can have a very beneficial effect on healing speed and on bone loss in the oral cavity. The latter effect in the oral cavity is particularly important for the maintenance of crestal bone height in the lower and upper jaw, a very important factor for implant attachment.

These observations all point to the fact that electromagnetic fields with very specific pulse characteristics can be non-invasively inductively coupled to biological systems to control cell behavior. In the first applications of these principles, the effect on bone cells has been investigated. However, other biological processes can possibly be shown to be controllable by similar methods, e.g. malignancy, neuro-inclination, inflammatory processes and immune response among others.

In summary, it is believed that a unique electromagnetic and surgical non-invasive treatment technique has been discovered. Induced pulse characteristics appear to be high

significant, especially those concerning time-frequency-ampli-

in clear relationships with the entire pulse or pulse sequence. It is believed that choosing particular time-frequency-amplitude relationships may be the key to successful treatments of varying cell behavior in a diversity of tissues.

Throughout the specification for Mode 1, a pre-

) drawn pulse repetition rate of between 65 and 76 Hertz specified for bone and other hard tissue. The exact limits of the pulse repetition rate are not known for all types of tissues and cells. It is believed that preferred work areas

will vary depending on tissue and cell type. E.g. one has

in achieved positive results in the treatment of soft tissue at 20

Hertz.

It will be understood that the methods and apparatus described in the preceding are amenable to modification.

While e.g. fig. 1 and 2 illustrate a treatment unit fastened to the leg, so one can e.g. use treatment units that are incorporated into plaster casts. Furthermore, treatment can be carried out by using one or more coils of varying shape placed close to the tissue and/or cells to be treated. In fact, human treatments have involved coils placed on opposite sides of a broken bone. Coils with metal cores can also be used. In case of treatment in the oral cavity, it is believed that double coils are advantageous, placed e.g. on opposite sides of a tooth pit to stimulate the inclination of this pit. In connection with fig. 7-16 some are described here

specifically useful processing units and methods,

Fig. 7 and 7A illustrate a body treatment or dressing apparatus, most useful for the treatment of broken bones or non-unions in arm and leg parts, i.e. where the leg region to be treated is relatively longitudinal. The apparatus comprises two coil holders 50 - 51, each of which contains an electric coil of the type already described, and they are flexibly connected to allow easy attachment on opposite sides of the area to be treated.

The two units 50:— 51 can be of the same construction, which essentially consists of a rigid embedding of its coil windings in a binding mass of hardened elastomer or plastic material; however, in the preferred embodiment, each unit such as unit 50 comprises a casing consisting of flanged concave front and convex rear panels 52 - 53 with the flanged edge 54 on the front panel 52 in continuous telescopic overlap to the similar flange 55 on the back panel 53. Mutually fitting and abutting inwardly projecting knob and foot formations in the panels 52 - 53 such as at 56 enable the two panels to be bolted together in the precisely located relationship shown in fig. 7A. The respective inner and outer panels of unit 51 are exactly the same as for unit 50 except that as a further element of the invention rectangular recess 57 is formed inside panel 52 for locating purposes which will be explained later. The fixed knob or foot formations at 56 are preferably continued inwardly from the flanged peripheries of panels 52-53 through which they define circumferentially located means for locating the inner limit of windings of coil 58 within the flange 55 of the back panel 53. The coil windings may be rigidly fixed in place to and in the flange 55, or they may suitably be held by compressible material such as urethane foam, compressed as the bolted connections are established with 56.

The flexible connection of the units 50 - 51 is shown containing an electric cable 59 to establish parallel connection of like coils 58 in the respective units 50 - 51, the polarity of such connection is such that the magnetic lines of force in the two coils 58 and in space in between is flux-conducive when the face panels (the concave ones) of the units 50 - 51 are in face-to-face relationship with each other. Removable connecting contact to the coils 58 from the energizing circuit in fig. 4 or 5 is shown in the form of a socket 24 - 26 via the unit 51. Typically, each of the two coils 58 has an inductance of the order of 5000 microhenries, so that when they are in their preferred parallel relationship, the inductance presented to the given effect of it in the circuits of fig. 4 and 5 that come to mind, 2500 microhenries.

The flexible connection of the units 50 - 51 also includes connecting strap means such as e.g. of "velcro" material to make it possible to adapt the dimensional needs

according to each patient's particular circumstances. The unit 50 is thus

i shown with a first such strap member 60 attached to its rear panel 53 with a free end extending a distance L to one of the side edges of the unit 50; similarly, unit 51 is shown with another strap member attached to its rear panel,

and with a first free end 61 with a length L, which protrudes

) laterally to provide an adjustable overlapping connection to the free end of the belt 60. The opposite end 62 of the belt carried by the unit 51 is also free, but of considerably greater length L^/ to allow full encirclement with the belt connection

as a means of detachably attaching both units 50 - 51 to the treatment region of the body part; preferably the length

sufficient to allow the velcro material surface 63 at the inner or front surface of the free end 62 to encircle the body part cg to allow the region 63 to have a removable velcro fastening with a suitably equipped back surface of the same strap element as at the region for its fixed mounting to the back panel of unit 51.

The coils 58 are shown with a generally elliptical configuration. These coils should have sufficiently large internal dimensions in relation to their final installed location for bone treatment to ensure relatively uniformly distributed concentrated flux within the treatment zone. Elementary principles and preferred dimensional relationships for a two-coil flux-carrying circular form will be discussed later with a view to

on minimizing the creation of stray flux lines between the two coils. Here it is sufficient to point out that by using the cylindrical concave-convex shapes described for panels 52 - 53, the coils 58 are necessarily also adapted to a geometric shape that is cylindrically curved, the longitudinal axis of the ellipse being parallel to the axis around which each coil 58 is cylindrically curved. Thus, when units 50 - 51 are positioned for body treatment, the concave sides of both coils 58 are in face-to-face relationship with the minor-shaft located coil regions m - n of unit 50 in closer proximity to the corresponding minor-shaft located coil regions m' - n' in unit 51 than is the case for coil-to-coil spacing of corresponding major-axis located coil regions p-q and p<1>- q'; as a result of this relationship, any tendency to establish stray flux lines between the corresponding minor-axis coil regions m-n' and m'-n is minimized.

Specific use of the body treatment apparatus in fig. 7 and 7A will be better understood by further reference to fig. 9 and 10 using a sacrificial locating block or wedge device (shown in Fig. 8) of a suitable molded plastic such as polypropylene. The locating device in fig. 8 comprises a block 65 in the form of a rectangular prism sized for removable locating reception in the rectangular recess 57 which sits centrally in the concave panel 52 of unit 50. Elongated mounting strips 56 are molded integrally with the prism 65. They extend in opposite longitudinal directions from the base of the prism, and they are relatively rigidly pliable for easy bending adaptation to. special body or casting forms. The thickness and material of the strips 66 should also be such that they allow cutting to shorter lengths according to what may be needed for certain applications. A pressure-sensitive band 67, which may contain metal foil, metal wire or other material, opaque to radiological irradiation is shown removably adhered to the peripheral edge of block 65.

In the first stages of the use of the apparatus in fig. 7, i.e. during the period when the separated halves of a broken bone or a non-union are to be held for electromagnetically induced treatment according to the invention, the damaged limb, e.g. leg 70 in fig. 9, first placed in a cast 71 that overlaps the damaged area. The leg is then placed on a table 72 so that the damaged area can be viewed under radiological irradiation, schematically indicated by an arrow with the text "X-rays", and immediate and ongoing viewing is made possible with appropriate "video-scanning" and forward- display methods 73 - 74. The device in fig. 8 is then placed

on a local area of cast so that the opaque om-

view of prism 65 can be seen at 74 as a rectangular frame surrounding the central zone of the fracture or non-union region to be treated. Then the opaque

frame is seen in the viewer in the correct surrounding position around the damaged leg area, i.e. after the necessary adjustments to the position to achieve conformity have been made, the strip ends 66 are attached to the cast 71 using adhesive tape as indicated at 68. The cast 71 can then be developed further over the strip ends 66 to ensure a permanent position of the locating prism as a fixed part of the casting 71. When the prism 65 is thus attached to the casting 71, the strip 67 can be removed and

is thrown, and the patient is finished for the apparatus in fig. 7, which is assembled by first locating (i.e. using the wedge) the unit 50 via the cavity 57 of the prism 65, to adjust the "velcro" overlaps 60 - 61 to locate the unit 51 in diametrically opposite relation to the unit 50 (on the other side of the item 71), and then by using the strap 62 to complete and secure the surrounding overlap described for the inner surface region 63. The electrical connection is then closed at 24 - 26, and the treatment can begin in the manner already is described. It should be noted that if the surface of the concave panel on each unit 50 - 51 is not of soft tissue, there may be a tendency for the formation of lime dust through local mechanical rubbing of the cast 71 with repeated assembly and disassembly of the units 50 - 51. Such dust formation can be minimized by attaching a lining of foam plastic or similar pliable material to the concave panel of one or both units 50 - 51, and such a lining is shown at 75 in fig. 10. Furthermore, the use of a layer of foam plastic will ensure the patient's dry comfort while the friction material contributes to stable placement and retention of the treatment coils.

Fig. 11 shows an apparatus for body treatment particularly suitable for the treatment of leg injuries in the heel area. For simplicity, Fig. 11 is limited to showing rigid structural components, and the foam plastic lining carried by such a structure for patient convenience (ie to avoid chafing) is omitted. Fundamentally, the rigid structure in fig. 11 a tubular shell 80 of methyl methacrylate, open at its longitudinal ends as well as locally open at 81 over an angle (around the longitudinal axis of the shell) and between the longitudinal ends of the shell 80. An "S"-shaped space 82 which may be of the same material as the shell 80, has its upper end attached at 83 to the rear end of the shell 80 at the opening

81, and its lower end 84 extends along the diametrically opposite area of the inner surface of the shell 80 to provide a plate for basic support of the underside of the foot 85 which is inserted through the opening 81. The respective courses of two arcuate elliptical coils 86 - 86' are outlined in dashed lines. These coils will understandably be attached to the shell 80 in a vertically opposite relationship, the upper coil 86 is attached to the inside of the shell 80, just inside the edge of the opening 81, and the one below the coil 86' is similarly attached in the diametrically opposite position . The coils 86 - 86' thus have a permanent relationship to each other, very similar to what is described for coils 58 in the units 50 - 51 when they are in position mounted on the body, and it will be understood that the coils 86 - 86' are preferably electrically connected in parallel, in flux-promoting polarity, that they are supplied with power by one or other of the energizing circuits in fig. 4 and b.

In addition to the coil-locating and foot-supporting structure described, the apparatus in fig. 11 side shock absorbers 87 - 88 which may be curved strips of the same plastic material as the shell 80. The strips 87 - 88 are preferably rigidly pliable to preserve the treated area against mechanical shock in the event of an inadvertent contact with furniture or other objects.

Fig. 12 is a simplified diagram similar to fig. 11 to illustrate another body treatment apparatus, designed for use in an injured ankle area or to a lower tibia/femur region. Again, the fundamentally fixed structure is seen to consist of a tubular shell 90 of suitable plastic material. A single local opening 91 in the side wall of shell 90 has a straight lower edge near a bottom plate or rest plate 92 which spans diametrically across the lower end of shell 90. Opposite electric coils 93 - 94 are attached to the inner surface of shell 90 in such height that the line 95 through their symmetrical midpoints geometrically cuts through the center of it

damaged area, preferably confirmed by X-ray observation on guideline 95. The design of the coils 93 - 94

may be circular or elliptical, but it is preferably cylindrically curved in accordance with the local surface of the shell to which each is attached; in the case of elliptical coil shapes, the longest shaft should preferably be oriented vertically in accordance with the discussion above regarding the coils 58 in fig. 7. Connecting and energizing the coils 93 - 94 is as described for other two-coil devices.

It will be seen that the devices and methods described represent major advances in surgical non-invasive treatment of body cells, particularly in connection with bone healing and healing. With respect to the body treatment apparatus described herein, the full range of dimensional limitations has not yet been established, but certain beneficial areas can be described in general terms, particularly coil pair embodiments, illustrated in conjunction with

fig. 7 - 12.

On an elementary basis, it is convenient to think of the situation with circular coils shown in fig. 13, where equal circular coils A-B with internal diameter D^ are placed on a common central axis of symmetry in parallel planes at a distance S from each other, and where the coils A-B are excited in a flood-promoting relationship. If the distance S is small enough in relation to the diameter D^, essentially all lines of force in the coils A-B will extend continuously in between generally in a straight line, which may however hang down as indicated by the profile 96. If the distance S is greater (again in relation to to the diameter D-^) , some stray lines of force 97 may develop to the detriment of the development of uniform high-density flux in the central space S. In general, the suspension 96 taken into account, and considering that the treatment zone is usually located in the middle of the space S , it is convenient to regard the coils A-B as being desirably effective in producing the uniform flux distribution over an imaginary cylinder 98 with diameter D ~ tangential to the suspension profile 96. From experience to date it can be determined that for body application of the nature described here the span S must be equal to or smaller than the diameter , and of course D2 (the effective diameter of the body treatment zone) will always be significantly smaller than n D^; it approaches the size of D, only when the coils are close together. As a practical consideration when applying coil pairs to the body, it is considered that the nominal internal diameter D, of the coils should be at least 1.5 times the diameter of the effective body treatment zone, and this has been found to be a reliable method for coil spacing S in the substantially as large as the internal diameter.

Having thus considered the criterion factors for the simplified case of flat circular coils, it is possible to develop general criteria applicable to elliptical coils which are "wrapped" in general accordance with a cylindrical arc. Fig. 14 schematically shows coil 58 the relationship discussed in fig. 7, where the cylindrical arc of the "wrapped" coil curvature is about a central axis 100 which is parallel to the major axis of the coil ellipse. Fig. 15 schematically shows a coil 58 relationship, where the cylindrically curved curvature of the coils is parallel to the small axis of each coil. In both cases, the typical resulting treatment zone is indicated by dashed lines in the front section (Fig. 14a and Fig. 15a).

For the purpose of deriving the central magnetic field distribution between opposite coils 58, their major axis areas (denoted p-q-p'-q' in Fig. 7 can be considered to be at maximum separation S^, and their minor axis areas (denoted m-n-m'-n ' in fig.

7) can be considered to be at minimal separation S2 as seen in fig. 14b. When this is the case, the major axis region's contribution to the magnetic field can be considered to apply to the span S

(in fig. 13) equal to S^ (in fig. 14b) in connection with an effective internal diameter D^ which corresponds to the major axis of the ellipse; in a similar way, the purple axis region's contribution to the magnetic field can be considered to apply to the span S2 (in Fig. 15b) in

hang down an effective internal diameter Dmin, which corresponds to the minor axis of the ellipse. For section considerations on a plane between the planes of the major axes and minor axes, the field will follow distribution considerations lying between those that determine the distribution in the plane of the major axes and minor axes respectively...

The argument above regarding the distribution of the magnetic field for fig. 14 the form can also be used for fig. 15, of course with the exception that the patterns will be different because of the cylindrical curvature around an axis parallel to the small elliptical axis.

The arrangement in fig. 16 shows the use of two generally cylindrically curved coils 58", where the cylindrical arcs form a set of spacing ratios appropriate to the desired application, and the electrical coupling is again understood to be flux-carrying. The coil arrangement of Fig. 16 will understandably be used over a generally cylindrically curved treatment zone, such as in the case of a jaw segment or group of teeth, the latter indicated schematically at 101 in Fig. 16b. Depending on the size of the coils 58" it will be understood that they can be maintained at a fixed distance using a suitable " bracket" (indicated by 102) which only spans teeth in the case where both coils are inserted in the mouth, and which spans teeth as well as the nearest cheek (via the mouth) in the case where one coil is inside the mouth, and the other is outside the mouth. It will also be understood that with a view to a certain flux distribution inside the mouth such as in dental and/or jaw osteogenesis, the inner coil 58" can be of smaller physical size than the outer coil 58".

It is understood that the preceding discussion of general principles has been made with a view to elucidating, and not limiting, the invention, and that modifications can be made without deviating from the scope of the invention. If e.g. for certain purposes it is not possible to construct both coils in a coil design so that they correspond completely in geometry and electrical properties, as suggested above for a dental or jaw application, there may still be a useful application for the invention by to use magnetic flux distribution which may not be as uniform as discussed in connection with fig. 13 - 16, but which nonetheless benefits from the flux-promoting interaction of two coils on

opposite sides of the damaged area under treatment, which advantage is of course a result of the excitation of such coils with specially characterized inserts discussed in connection with fig. 4-6.

Figures 17-20 relate to coil configurations useful for developing flux along, and therefore usually parallel to, the longitudinal direction of a body part to be treated. IN

fig. 17 is a coil of a plurality of equal windings 105 spirally developed along a tubular support joint 106 of suitable plastic or other non-magnetic material. The windings 105 can

lie on the inner or outer surface of the tube 106, and the axial length of the winding should be such that it overlaps both longitudinal ends of the bone fracture or the like to be treated.

In fig. 18 again shows a simple coil carried by one of the cylindrical surfaces of a tubular link 108, but the latter is cut locally at an opening 109 (in the same way as described at 81 in Fig. 11) to allow insertion of a joint region such as an elbow with the forearm protruding through an axial end of the tubular joint 108 and with the upper arm

projecting radially out through opening 109. The single epole is shown first as a plurality 110 of spiral turns continuously connected by an axially stretched turn 111 to a new plurality 112 of similar turns, the pluralities 110 - 112 being placed on opposite longitudinal sides of the opening

109 and with a distance that is at least not greater than the effective diameter of the windings 110 - 112.

The arrangement in fig. 19 is similar to that in fig. 18, except that the respective pluralities of windings 110 - 112 are electrically connected in parallel in a flux-carrying relationship. One

central access port is understood to be arranged in the tubular joint 108 at a point directly opposite the opening 109, to allow wire connections for excitation to be arranged outside all windings, i.e. no supply lines pass within the windings at 110 - 112.

In the device in fig. 20 are two coil compositions 115_

116 designed for mounting on the respective ends of a longitudinally split, compliant support joint 117 of non-magnetic material. The longitudinal slot at 118 allows

a certain degree of flexibility in the application to a body part, such as during its application past the heel region of a part of a leg to be treated. Each coil unit is shown as a relatively rigid annular arrangement of a winding in a form of hardened curable material and formed with a recess 119 where the coil unit is telescopically mounted over the end of the proximal end of the tubular link 117. The inner end of each recess has a internal flange to limit the coil assembly and to determine repeatable accurate spacing between the two coil units. Electrical connections to the two coil units are shown to be parallel and they should be in a flux-carrying relationship, and a flexible cable connection is indicated at 120.

It will be understood that various simplified ways have been used to make reference to the drawings easier to understand. eg: in the embodiments of the coil supports with a fixed frame in fig. 11, 12 as well as 17 - 20, it must be understood that when mounting on the body, certain cushion-forming f<5ring materials such as urethane foam are preferably attached to the described construction in order to achieve a comfortable fit against the body at the attachment point, but to show such for would only complicate - see the drawings. In connection with fig. 9, only the casting 71 is shown as an illustration, since the wedge device 65 can be mounted on the outside in another way, such as e.g. on an external attachment such as e.g. a wrap gaiter, or on the body part itself (ie without a cast, as in the later phases of a leg cast), and the cast can be of other materials than plaster, e.g. the material known as orthoplast.

Claims (8)

1. Electromagnetic body treatment apparatus for surgically non-invasive modification of the growth, healing and maintenance behavior of living tissues and cells by means of a specific and selective change in the electrical environment, comprising an electrical coil device (86, 86'; 93, 94; 110, 111, 112), a rigid, tubular frame (80; 90, 180) which carries the coil device to support it in relation to an afflicted body area to be treated, the coil device winding around a flux development axis through a treatment zone for recording the afflicted body area, and a pulse generator device for electrically stimulating the coil device with a sequence of low-voltage pulses, characterized in that the rigid, tubular frame in its tubular wall is designed with an opening (81; 91; 109) so that a body part with the afflicted area can be movably introduced into the aforementioned frame part and passed through the frame's opening to place the affected area in the coil device's treatment zone. 2. Treatment device according to claim 1, characterized in that the coil device comprises two coils (86, 86') which are mounted at diametrically opposite locations of the tubular frame, and that the opening is located inside one of the coils. 3. Treatment apparatus according to claim 1, characterized in that the coil device comprises two coils (93, 94) which are mounted in diametrically opposite locations of the tubular frame, and that the opening is located between the coils. 4. Treatment device according to claim 2 or 3, characterized in that each of the coils is essentially elliptical in shape. 5. Treatment device according to claim 1, characterized in that the coil device comprises at least one coil winding which has a number of windings which are wound essentially helically along the axis of the tubular frame, that said number of windings is arranged as axially separated helical lines (110, 112) with a distance between the screw lines that exceeds the effective diameter of the windings, and that the aforementioned opening (109) is located between the screw lines. 6. Electromagnetic body treatment device for surgical non-invasive modification of the growth, healing and maintenance behavior of living tissues and cells by means of a specific and selective change in the electrical environment, characterized in that it comprises a single electrical coil having a number windings wound in a substantially helical manner along an axis extending through an afflicted body area to be treated, a holding device for retaining the windings in position outside the body, and a device for electrically stimulating said coil with a sequence of low voltage pulses. 7. Electromagnetic body treatment apparatus for surgical non-invasive modification of the growth, healing and maintenance behavior of living tissues and cells by means of a specific and selective change in the electrical environment, comprising an electrical coil device (115, 116), a holding device (117 ) for supporting the coil device in relation to a troubled body area to be treated, and a pulse generator device for electrically stimulating the coil device with a sequence of low-voltage pulses, characterized in that the holding device comprises a longitudinally split tube (117) of pliable, non-magnetic material which is temporarily deformable during assembly on a body part to be treated, and which in the thus assembled state is circumferentially continuous, and that the coil device comprises two identical coil winding sub-assemblies, each of which is adapted for end assembly on the respective ends of the said tube, the mutual distance between coil winding-under the assemblies in the assembled state are smaller than their effective diameter, and a flexible device (120) electrically interconnecting the coil winding subassemblies for simultaneous stimulation in a flux-promoting relationship. 8. Treatment apparatus according to claim 7, characterized in that each of the coil winding sub-assemblies comprises a number of windings which are embedded in a hardened, ring-shaped body of non-magnetic, hardenable material which has a recess at one end for telescopic assembly over one end of the aforementioned pipe, the inner end of the recess forming a flange to limit the telescopic assembly when it abuts against the pipe end.