AU2002300642B2 - Magnetic Field Therapy - Google Patents

Description

S&F Ref: 600455

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

Name and Address of Applicant: Actual Inventor(s): Address for Service: Invention Title: Advanced Diagnostic Development Pty Ltd 136-146 Garfield Road Horsley Park New South Wales 2164 Australia Arnoldus Petrus van Mullekom Spruson Ferguson St Martins Tower,Level 31 Market Street Sydney NSW 2000 (CCN 3710000177) Magnetic Field Therapy ASSOCIATED PROVISIONAL APPLICATION DETAILS [33] Country [31] Applic. No(s) AU PR7117 [32] Application Date 17 Aug 2001 The following statement is a full description of this invention, including the best method of performing it known to me/us:- IP Australia Documents received on: 1 6 AUG 2002 t Batch No: 5815c -1- MAGNETIC FIELD THERAPY Technical Field of the Invention The present invention relates to a method and apparatus for applying magnetic field/s to a biological entity (such as humans and animals) as a means of therapy.

Background Art The application of magnetic fields to treat cells of the human or animal body has been proposed for a wide range of physiological conditions.

One example in the prior art, is the RONEFOR® Model 2, EL VX50 device that originated in Austria. A magnetic field which is pulsating at around 50 Hz is locally applied to the human body. Typically, this therapy is applied for 30 minutes at a time, twice a day. However, the required "intensity" magnetic flux density) for this treatment is relatively high: 400 5,600 microteslas (pT) (equivalent to 4 -56 Gauss).

Another example in the prior art, is the Quantron Resonance System® ("QRS® manufactured by Magnavit AG of Liechtenstein, in which device a pulsing magnetic field is applied with an intensity of 15 30 T. The electrical signal used to produce the magnetic field includes a base frequency of 200 Hz and further frequencies of 3 and 28 Hz. The signal is applied in a repeating cycle of 205 pulses over 4.9 ms followed by an interruption of 5 ms. The intensity is varied according to the required therapy. However, only around 30% of body cells are estimated to be able to be reached with this arrangement.

The present invention has as an object improved therapeutic performance over the prior art.

Disclosure of the Invention The invention discloses an apparatus for applying a thereapeutic magnetic field to a biological entity. The apparatus comprising a signal generation unit for generating an electrical treatment signal having a plurality of superimposed frequency components components of approximately 300 Hz, 600 Hz, 800 Hz and 1,000 Hz. An induction coil mat is connected to said signal generation unit, and generates a magnetic field in accordance with said electrical signal.

The invention further discloses a mthod for applying a therapeutic magnetic field to a biological entity (human or animal).

The fundamental frequency components discussed above are understood to be primarily responsible for initiating the biochemical processes within the body, for increasing cell membrane permeability and re-establishing normal potentials to damaged cells. In particular, these high frequency components are believed to be primarily responsible for providing an improved calcium cascade effect within the cells, where Ca 2 ions penetrate cell membranes. These high frequency signals alone can provide beneficial treatment effects.

One or more relatively low frequency components, in the range 3 Hz to 32 Hz, can be added. These frequencies are chosen in accordance with a desired treatment mode of operation.

Brief Description of the Drawings Fig. 1 is a schematic representation of the main functional components of a magnetic field therapy apparatus according to an embodiment of the present invention; Fig. 2 is a schematic, functional block diagram of a power supply/control unit of the magnetic field therapy apparatus of Fig. 1; Fig. 3 is a layout for a user interface control panel for the magnetic field therapy apparatus of Figs. 1 and 2; Fig. 4 is a schematic diagram of a coil used in the magnetic field therapy apparatus of Figs. 1 3; Fig. 5 is a time domain representation of a basic carrier signal used in the operation of the magnetic field therapy apparatus of Figs. 1 to 3; Figs. 6A to 6C, 7A to 7C, 8A to 8C, 9A to 9C, 10A to 10C, 11 A to IIC, 12A to 12C, 13A to 13C and 14A to 14C each illustrate a pair of time domain representations of a therapy signal used in the operation of the magnetic field therapy apparatus of Figs. 1 to 3; Figs. 15A to 15B each illustrate a time domain representations similar to that of Fig. 6A, although using modified parameters as will be described; Fig. 16 shows a time domain waveform for operation intended to promote sleep; Figs. 17A and 17B, 18A and 18B, 19A and 19B, 20A and 20B, 21A and 21B, and 22A and 22b show results obtained in clinical trials; Fig. 23 is a schematic diagram of a multi-coil induction mat, according to an alternative embodiment; Fig. 24 is a cross sectional view of the multi-coil induction mat of Fig. 23, and; Fig. 25 is a representation of the multi-coil induction mat of Fig. 24, showing magnetic fields being produced during operation.

Detailed Description including Best Mode Apparatus Referring to Fig. 1, a magnetic field therapy apparatus 1 includes a therapy control unit 6 connected to either a single-coil induction mat 5 or a multi-coil induction mat 2, depending upon the type and extent of magnetic therapy intended to be applied.

The therapy control unit 6 typically includes a microcontroller based system which provides a pulsing, electrical output which will be referred to as a "therapy" signal.

The therapy signal is controlled in accordance with a desired field strength, determined by -4current flow, and a desired waveform characteristic (to be later described), to provide an excitation source for each of the mats 2, In a domestic context, the therapy control unit 6 typically includes an EEPROM memory chip in which to store operating and historical data. However, in a medical practice or therapist's context, the therapy control unit 6 can be connected to and communicate with a personal computer 7 to provide further management and record keeping facilities.

The single-coil mat 5 is made of foam rubber having a thickness of around mm. The single-coil mat 5 includes an embedded, flat, air core induction coil 8a, which typically includes around 30 50 turns over a total length of around 10 100 m. In one specific example, the induction coil 8a has 35 turns providing a total length of 60 m, and is wound from a stranded conductor having a cross-sectional area (csa) between 22 2 mm 2 and 1 mm and preferably 0.75 mm.

Referring to Fig. 4, an example of typical dimensions of an induction coil 8a is shown.

The single coil mat 5 is sufficiently flexible to be able to be wrapped around a human joint such as a knee, elbow or the like to thus enable localised therapy to be applied.

The multi-coil mat 2 is similarly constructed to the single-coil mat 5 although is embedded with four, rectangular, flat, air-core induction coils 3a 3d.

In one form of the multi-coil mat 2, the therapy control unit 6 provides a single source of excitation to each of the induction coils 3a 3d. However, in another embodiment of the multi-coil mat 2, each of the induction coils 3a 3d are separately connected to the therapy control unit 6 so as to be independently excitable. This enables a different field intensity and/or frequencies to be simultaneously applied to different parts of the user's body. For example, when lying down on the multi-coil mat 2, coil 3a can generate a lower intensity near the user's head and coil 3d can generate a higher intensity near the user's feet.

Magnetic Field Waveforms The therapy control unit 6 synthesises the therapy signal PAM(t) which is used to excite the coils 3a to 3d and 8. The therapy signal J.AM(t) is made up of a "basic" signal IT(t) and a "user" signal gM(t), which are superimposed added) together with a form of amplitude scaling applied.

Referring now to Fig. 5, an example of the basic signal, PIT(t), (or Vo.tpt) is shown, which includes the following four sinusoidal frequency components and a dc component (0 V in this case), in superposition: fi 300 Hz f2 600 Hz 3 800 Hz f 4 1000 Hz The fundamental "frequency" components of the basic signal discussed above are understood to be primarily responsible for initiating the biochemical processes within the body, for increasing cell membrane permeability and re-establishing normal potentials to damaged cells. In particular, these high frequency components are believed to be primarily responsible for providing an improved calcium cascade effect within the cells, where Ca 2 ions penetrate cell membranes. These high frequency signals alone can provide beneficial treatment effects.

The "low frequency" component of the user signal is believed to be primarily responsible for providing a resonance effect by coinciding with the natural frequencies of the body brain and nervous system activity and cell structures), and is specific for the treatment applied.

The relevant frequencies of the user signal 9iT(t) depends upon the nature of the therapy to be applied. The frequency of the user signal PLT(t) is typically within the range of frequencies of the human electroencephalogram (EEG), or between 3 Hz to 32 Hz.

The frequency bands of the human EEG are as follows: Beta band: >13 Hz Beta 1: 14 18 Hz Beta 2: >18 Hz Alpha band: 8 13 Hz Theta band: 4 7 Hz Delta band: 0.5 3.5 Hz The user signal LM(t) is sinusoidal with an amplitude of 1 unit. This enables the user signal gtM(t) to be weighted with an amplitude factor between 20% to 100% to ensure that the current flow through each of the coils 3a 3d and 8, and resultant intensity of magnetic field generation, is maintained at a constant level for the duration of a therapy program.

The therapy signal tAM(t) includes a further scaling factor applied to the superimposed frequencies such that they are scaled back so that the intensity across the frequency range remains largely the same and below a maximum level.

It is believed by the inventor that a therapy signal 9AM(t) composed in accordance with the above principles can provide at least similar benefits to those realised from prior art devices, but with generally lower field intensities. Lower field intensities are believed to provide a safer situation against adverse effects to the patients. Also, these lower intensities are more likely to conform to various regulatory standards.

Consistent with the basic principles expressed, a number of therapeutic programs, based on various frequencies and durations of user signals combined with the basic signal 9LT(t), have been devised. Each of these programs are directed to specific physiological areas, as determined by testing, as follows: 1. Vitalisation/Blood Circulation, 2. Relaxation, 3. Vigilance/Activation, 4. Pain, Relaxation and Revitalisation, 6. Sleep.

-7- When treating for vitalisation or blood circulation, the user signal pIM(t) is chosen to firstly activate frequencies in the beta band and thereafter frequencies in the alpha band.

When treating for pain, it should be taken into consideration that most patients will also be taking some form of analgesic drugs, which can cause artificial changes in the human EEG, for example: there can be an increase in theta activity (4-7 Hz), a decrease in alpha activity (8-13 Hz) which is particularly the case when the drug ASS is taken, in which case the alpha rhythm is destroyed to a large extent, and there can be an increase in beta 3 frequency (21-30 Hz), particularly

TM

with the use of the drug Pentazocin T M The program concerned with relaxation and revitalisation program a combination of programs 2 and 3 are utilised.

When treating for sleep, the user signal JiM(t) is chosen so that the percentage of the theta band is greater than When treating for vigilance, generally the opposite to the sleep program is sought.

Waveform Sets It is useful to now describe a set of waveforms that can be utilised in the respective therapeutic programs. The waveforms are characterised by an algebraic summing, as described above.

Referring to Fig 6A, the therapy signal 9AM(t) or Votp,,t includes a user signal JLM(t) or Vvar having a frequency of 3 Hz and ampfact of 100%.

-8- Figs 6B and 6C show graphs in a similar format to that of Fig 6A, except that ampfact of the user signal is 60% and 30% respectively.

Figs 7A to 7C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 5 Hz.

Figs 8A to 8C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 8 Hz.

Figs 9A to 9C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 12 Hz.

Figs 10A to 10C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 16 Hz.

Figs 11 A to 11 C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 20 Hz.

Figs 12A to 12C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 24 Hz.

Figs 13A to 13C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 28 Hz.

Figs 14A to 14C each show upper and lower graphs in a similar format to that of Figs 6A to 6C respectively, except that the frequency of the user signal is 32 Hz.

An example of a system that could be provided for a user or patient operable apparatus includes the selective availability from a group of the six "main" programs to and two "short" programs and These programs vary in their frequency patterns and amplitude factors, and are as follows.

Operation of Therapeutic Programs -9- During operation of all of the following programs, the user interface panel displays the intensity of the coil/s in terms of six increments over the full range of available intensities for that particular program.

Main Program no. 1 Vitalisation/Blood Circulation: The total duration is minutes by default, although the user can adjust this up to a maximum of 30 minutes. The intensity is 1.5 T by default, although the user can adjust this value up to a maximum of gT.

User Signal Frequency Duration Amplitude Factor pM(t) (Hz) (sec) 21 20 18 20 16 20 30 14 60 13 120 100 12 140 100 11 140 100 140 100 9 120 100 8 60 8 30 TOTAL 900 secs or 15 mins.

Main Program no. 2 Relaxation: The total duration is 15 minutes by default, although the user can adjust this between a minimum of 5 minutes and a maximum of minutes. The intensity is 1.5 T by default, although the user can adjust this value to a maximum of 15 T.

User Signal Frequency Duration Amplitude Factor SM(t) (Hz) (sec) 17 10 16 10 10 14 10 13 10 12 10 11 20 20 9 20 8 20 7 60 100 6 80 100 140 100 4 240 100 3 180 100 3 20 3 15 3 15 3 10 0 TOTAL 900 secs or 15 mins.

Main Program no. 3 Vigilance/Activation: The total duration is 15 minutes by default, although the user can adjust this from a minimum of 5 minutes and to a maximum of 30 minutes. The intensity is 1.5 T by default, although the user can adjust this to a maximum of 15 JT.

User Signal Frequency Duration Amplitude Factor pM(t) (Hz) (sec) 10 6 20 7 20 8 60 100 9 80 100 150 100 11 150 100 12 120 100 13 60 14 60 60 16 30 17 30 18 30 21 20 TOTAL 900 secs or 15 mins. Main Program no. 4 Pain: The total duration is 15 minutes by default, although the user can adjust this to a maximum of 30 minutes. The intensity is 1.5 gT by default, although the user can adjust this to a maximum of 150 uT. It is noted that the user interface panel 10 will still display increments from step 1 to step 6, so as to maintain compatibility with the other programs which have a maximum of 15 iT at full scale.

User Signal Frequency Duration Amplitude Factor itM(t) (Hz) (sec) 32 30 -11- 30 28 40 100 26 80 100 24 120 100 22 120 100 80 100 16 60 14 40 12 20 20 8 20 7 100 100 6 120 100 6 20 TOTAL 900 secs or 15 mins.

Main Program no. 5: Relaxation and Revitalisation: The total duration is minutes by default. This program provides 1.5 T by default, although is adjustable by the user up to a maximum of 15 iT.

User Signal Frequency Duration Amplitude Factor pM(t) (Hz) (sec) 17 10 16 10 10 14 10 13 10 12 10 11 20 20 9 20 8 20 7 60 100 6 80 100 140 100 4 240 100 3 180 100 3 20 3 15 3 15 3 10 0 10 6 20 7 20 8 60 100 9 80 100 -12- 150 100 11 150 100 12 120 100 13 60 14 60 60 16 30 17 30 18 30 21 20 TOTAL 30 mins.

Main Program no. 6: Sleep: For this program a variable time can be chosen, with the basic signal at 80% together wit the superposition of each of a 2 Hz, 3 Hz, 4 Hz and 5 Hz signals. This is shown in Fig. 16. The inventor believes the characteristic 'wobble' that is evident in the composite waveform is responsible for assisting in advancing sleep. The amplitude of the basic signal reduces from 80% to 40% linearly over the course of the program. For example, if 40 minutes is chosen, then the amplitude reduces at 1% per minute.

.0 Short Program no. 1 Vitality/Blood Circulation: The total duration is minutes by default, although the user can adjust this to a maximum of 30 minutes. The intensity is 1.5 JT by default, although the user can adjust this to a maximum of 15 pT.

User Signal Frequency Duration Amplitude Factor Lp(t) (Hz) (sec) 21 7 18 7 16 7 11 14 20 13 40 100 12 46 100 11 46 100 46 100 9 40 100 8 20 8 10 TOTAL 5 mins.

-13- Short Program no. 2 Vigilance/Activation: The total duration is 5 minutes by default, although the user can adjust this to a maximum of 30 minutes. The intensity is JiT by default, although the user can adjust this to a maximum of 15 .LT.

User Signal Frequency Duration Amplitude Factor IM(t) (Hz) (sec) 3 6 7 7 7 8 20 100 9 26 100 50 100 11 50 100 12 40 100 13 20 14 20 20 16 10 17 10 18 10 21 7 TOTAL 5 mins. I Control Circuits and Operation Referring now to Fig. 2, the therapy control unit 6 is shown in functional block diagram form. The therapy control unit 6 includes a power supply 60, a digital signal processor (DSP) 61, a digital to analogue converter (DAC) 62, an active filter 63, a current feedback amplifier (CFA) 64, an output current monitoring unit 65, a coil selection unit 66, a display output unit 67, and a user selection input unit 68.

The power supply 60 provides a regulated d.c. output to enable operation of the other elements of the power supply/control unit 6, including a power circuit for driving the current feedback amplifier 64 which excites each of the induction coils.

The DSP 6b is programmed to digitally synthesise the therapy signal V..tpt or IAM(t) as earlier discussed.

-14- Preferably, each of the four high frequency signals V 1

V

2

V

3 and V 4 (which make up the basic signal), are generated with a sampling rate of 10 kHz and standardised to output a total power of 1W.

Each of these four high frequency signals VI, V 2

V

3 and V 4 (which make up the basic signal, in superposition) can be described by the following equations:

V

1 300 Hz K1 sin (2t x 300 x t),

V

2 600 Hz K 2 sin (27t x 600 x t),

V

3 800 Hz K 3 sin (2t x 800 x and

V

4 1,000 Hz K 4 sin (27r x 1,000 x t).

where: Kn amplitude scaling factor, each typically 0.8.

Next, the user signal ptM(t) or Vvar can be described by the following equation: Vvar (KI K2 K 3

K

4 x (ampfact/100) x (sin (27 x fvar x t)) where: ampfact variable amplitude factor and fvar required frequency of the user signal.

Finally, the therapy signal IAM(t) or Voutput is generated: Voutput (V V 2

V

3

V

4 Vvar) x Ko offset where: offset 0.1 to 3.5, nominally 0.25.

Ko a further scaling factor These calculations can be performed by any convenient computer program, as would be apparent to one skilled in the art.

The amplitude modulated signal that is output from the DSP 61 is converted to an analogue equivalent by the DAC 62. The analogue signal that is output from the DAC 62 is input to the active filter 63 which removes unwanted frequencies, in particular those resulting from "noise". The filtered signal that is output from the DAC 62 is then processed by the current feedback amplifier 64 which makes adjustments to the rms value of current flow, as required to achieve the required intensity. The signal that is output from the CFA 64 is then monitored by the output current monitoring unit 65 and a feedback signal fed back to the CFA 64.

The therapy signal JIAM(t) is input to the coil selection unit 66 which can selectively connect the therapy signal 9.AM(t) to either the multi-coil mat 2 or the single coil mat The DSP 61 is further connected to the display output unit 67 and the user control unit 68, both of which include a user interface panel Referring to Fig. 3, the user interface panel 10 includes the following: a start/stop selection button 11 and an associated status indicator 11 a; program selection buttons 12, 13, 14, 15, 16, 17 18 and associated status indicators 12a, 13a, 14a, 15a, 16a, 17a 18a, respectively; two time adjustment buttons 19 20 and associated status indicators 19a 20a, respectively; and two intensity adjustment buttons 21 22 and associated status indicators 21a 22a.

The start/stop selection button 11 is actuable to turn the programs "on" or "off', the status of which is shown by indicator 1 la. The program selection buttons 12, 13, 14, 16, 17 18 and associated status indicators 12a, 13a, 14a, 15a, 16a, 17a 18a are actuable to select any one of the available therapy programs. The time adjustment buttons 19 20 enable the user to selectively increase or decrease the duration of a therapy program from 5 to 30 minutes in six discrete steps of 5 minutes each. Similarly, the intensity adjustment buttons 21 22 enable the user to selectively increase or decrease the level of magnetic field intensity of a therapy program, within the range of 1.5 JT to 15 J.T in six discrete steps. However, levels of up to 150 LT can be selected when the pain therapy program has been selected.

Referring to Fig. 23, an alternative embodiment of the multi-coil induction mat 230 provides six, rectangular, flat, air-core induction coils 231-237, physically arranged as shown. This arrangement proportionally increases the magnetic field concentration that is -16produced in the longitudinal centre area of the mat 230. Therefore, a higher magnetic field concentration is directed to the spinal region of the user, which is thought to improve the overall effectiveness of the magnetic field treatment by activating important nerve cells of the body.

Referring now to Fig. 24, the multi-coil mat 230 of Fig. 23 is shown in cross-section along the lines XXIV-XXIV. Fig. 25 is the multi-coil mat 230 of Fig. 24, showing in phantom, expected magnetic fields produced during operation. Further, Fig 25 shows an approximate position of the user's spinal cord 250 when undergoing therapy. The additive effect of adjacent coils along the longitudinal centre area of the mat 230 can provide around a 70% greater concentration of magnetic field to the spinal region of the user's body.

Referring back to Figs. 1 and 2, a personal computer 7 can also be incorporated into the operation of the power supply/control unit 6 to provide patient and data management facilities for use in the context of a medical practice. These facilities can enabling storage of list/s of patients, entry of new patients including the creation of different files in accordance with anamnesis, automatic recording of therapy carried out for each patient including doctor's notes, printouts for accounting purposes and the like.

In an alternative embodiment, a negative ion generator can be incorporated into the operation of the magnetic field apparatus, so as to provide dual therapy.

Clinical Trials In confidential clinical trials utilising the 'Vitalisation/Blood Circulation' main program, a patient suffering from diabetes and extreme blood circulation problems in the legs was treated for 15 minutes. Fig. 17A shows a blood sample taken before the treatment, exhibiting the formation of 'rolls of coins' of red blood cells. Following the treatment, as shown in Fig. 17B, the red blood cells had desegregated, resulting in vastly improved blood flow for the patient. This, the inventor believes, leads to an improved state of the immune system and the amelioration of conditions associated with poor blood circulation. Particularly, blood pressure may be reduced and heart function improved.

-17- In other confidential clinical trials the treatment apparatus was utilised with patients suffering medical conditions, utilising the "circulation" program. Blood sample were taken from the patients before and after the treatment. Figs. 18A and 18B show the red blood cells before and after treatment for a 40 year old cancer patient. Figs. 19A and 19B show similar results for a 60 year old cancer patient. Figs. 18A and 19A are the 'before treatment' blood samples, and Figs. 18B and 19B are the 'after treatment' samples.

Fig. 20B shows the 'before treatment' blood sample for a 65 year old angina sufferer, with Fig 20A showing the 'after treatment' sample.

Additionally, a 75 year old diabetic patient was treated, and Fig. 21B shows the 'before treatment' sample, with Fig. 21A showing the 'after treatment' sample.

Finally, a 30 year old influenza sufferer was treated and, again, Fig. 22B shows the 'before treatment' sample and Fig. 22A shows the 'after treatment' sample.

The inventor believes that these blood tests provide evidence that some forms of cancer, angina, diabetes and influenza can be beneficially treated utilising the teaching of the invention. The treatment is in the nature of being temporarily amerliotaive, and not in the nature of a cure.

Industrial Applicability It is apparent from the above that the embodiments of the invention are applicable to the medical electronics field.

Claims (17)

1. Apparatus for applying a therapeutic magnetic field to a biological entity, said apparatus comprising: a signal generation unit for generating an electrical treatment signal having a plurality of superimposed frequency components of approximately 300 Hz, 600 Hz, 800 Hz and 1,000 Hz, and an induction coil mat connected to said signal generation unit generating a magnetic field in accordance with said electrical signal.

2. Apparatus as claimed in claim 1, wherein said frequency components are fundamental frequencies.

3. Apparatus as claimed in claim 2, wherein said signal generation unit scales each component frequency of the treatment signal.

4. Apparatus as claimed in claim 3, wherein said electrical treatment signal further includes one of more superimposed frequency components in a range between 2 Hz and 32 Hz.

5. Apparatus as claimed in claim 4, further comprising a user control unit generating user treatment settings provided to said signal generation unit, said user treatment settings corresponding to said further frequency components.

6. Apparatus as claimed in either one of claim 4 or claim 5, wherein said signal generation unit applies a weighting factor to said further frequency components.

7. Apparatus as claimed in any one of claim 3, claim 4 or claim 5, wherein said further frequency components are chosen from one or more of approximately 2 Hz, 3 Hz, 4 Hz and 5 Hz.

8. Apparatus as claimed in either one of claim 6 or claim 7, wherein said signal generation unit controls the amplitude of the composite electrical treatment signal to restrict the average output intensity from the induction coil mat to less than 150 t T. I:\DAYLIB\LIBE\Advanced Diagnostic Development\Magnetic Field Therapy\507505AU.doc -19-

9. Apparatus as claimed in any one of claims 1 to 8, wherein said induction coil mat includes at least two coils co-operatively arranged to increase magnetic field concentration in a region intended for a spinal area of a user.

10. Apparatus as claimed in claim 9, further comprising a negative ion generation means for simultaneous operation with said magnetic field.

11. A method for applying a therapeutic magnetic field to a biological entity, comprising the steps of: generating a magnetic field having a plurality of superimposed frequency components of approximately 300 Hz, 600 Hz, 800 Hz and 1,000 Hz; and applying said magnetic field to said biological entity.

12. The method as claimed in claim 11, wherein said frequency components are fundamental frequencies.

13. The method as claimed in claim 12, wherein each component frequency of the treatment signal is scaled.

14. The method as claimed in claim 13, wherein said electrical treatment signal further includes one of more superimposed frequency components in a range between 2 Hz and 32 Hz.

The method as claimed in claim 14, wherein a weighting factor is applied to said further frequency components.

16. The method as claimed in either one of claim 13 or claim 14, wherein said further frequency components are chosen from one or more of approximately 2 Hz, 3 Hz, 4 Hz and 5 Hz.

17. The method as claimed in claim 16, wherein the amplitude of the composite electrical treatment signal is controlled to restrict the average output intensity to less than 150 gT. I:\DAYLIB\LIBE\Advanced Diagnostic Development\Magnetic Field Therapy\507505AU.doc 20 Dated this 1 5 tIh day of August 2002 Advanced Diagnostic Development Pty Ltd Patent Attorneys for the Applicant SPRUSON FERGUSON I:\DAYLIM\LIBE\Advanced Diagniostic Development\Magnetic Field Therapy\507505AU.doc