Patentamt Office a i s c h e Patent s J E u r o p European Office europeen des brevets Publication number: 0 fi 181 0 5 3

EUROPEAN

PATENT A P P L I C A T I O N Int. CI.4: A 61 N 1/42

Application number: 85303733.1 Date of filing: 28.0S.85

Priority: 12.09.84 US 649706 Date of publication of application : 14.05.86 Bulletin 86/20 Designated Contracting States: AT BE CH DE FR GB U LU NL SE

Applicant: IRT, INC. P.O. Box 61 Haines Oregon(US) Inventor: WaHonen, James R. P.O. Box 61 Haines Oregon(US) Inventor: Bauer, Larry L. 1320 Walnut Baker Oregon(US) Representative: Wombwell, Francis et al. Potts, Kerr &Co. 15, Hamilton Square Birkenhead MerseysWe L41 6BR(GB)

@ Pulse electro-magnetic field therapy device with auto biased circuit and method for use. A method of treating animal tissue with a time-varying, magnetic field and a device for producing such a field wherein a substantially unipolar, rectangular electromagnetic treatment signal having pulses of a predetermined frequency and amplitude is generated. The signal is transmitted to a coil wherein it induces a magnetic flux. The magnetic flux so produced is applied to a treatment site to promote healing of tissue. A biasing circuit is provided in the device to prevent the occurrence of a reverse polarity pulse upon the fall of the magnetic flux induced by the fall of the generated pulse and to diminish high frequency ringing at the beginning of a treatment signal. < in o 00

Background and The producing varying instant present

Summary

of

the to

Invention a magnetic-fieldtissues therapy only with device a timeof the

invention for

pertains

therapy magnetic invention

device field.

treating

animal the

Specifically,

generates pulse which

a substantially assists faster

unipolar bodily healing and

electro-magnetic mechanism, enhancement

a patient's healing of

thereby of The

promoting

broken

bones

circulatory use of is

deficiencies. energy to produce modifications devices T. have The

electrical well known. of

in

living used of

tissue to

Electro-magnetic broken bones. Bone A.

been

promote

healing

Barker,

Design Physical 1,

a Clinical Physiology 9-16.

Electro-Maqnetic Measurement, use

Stimulator, 1981, Volume

Clinical II, No.

February, of of pulsed bone et al.

Pages

Additionally, to promote 4,315,503 Kraus, et

electro-magnetic is in described U.S. Patent in

fields U.S. No.

(PEMF) Patent

healing to

tissue and

No. to of

Ryaby,

3,890,953 Use

al. energy Patent to arrest 3,902,502 arthritic to Liss, et

electro-magnetic in U.S.

pain al.

has

been

disclosed

No.

A reading field of

of

the

rather treatment in

extensive teaches field and

literature that as to there the

in is

the little

electro-magnetic amongst pulse of

agreement effective treatment of one

researchers

the

most for merits

wave form,

frequency,

voltage

level into the

tissue

disorders. over the

Without other,

delving the

treatment to

method

present

invention device electroand

relates which

an e l e c t r o - m a g n e t i c - f i e l d - p r o d u c i n g a substantially of a predetermined rectangular, frequency

therapy unipolar,

generates pulse

magnetic

and

amplitude

which

includes

a biasing pulse of

means when a duty high

for

preventing

generation pulse means the

of

transient collapses

negative at the

a positive, cycle. frequency of The

unipolar biasing at

end

also

substantially of a treatment

eliminates pulse.

ringing

beginning with

A method

treating and The of

animal apparatus

tissues for

a time-varying, carrying out the

electro-magnetic method in are

field

taught.

method 1-100

involves hertz at an

generating amplitude

pulses of 1-15

a frequency

range

volts. premise may of form the teaching the is that of on a negative a positive the of vasopresence duty of highhealing electro-

A basic pulse or spike

which

upon

collapse effect

electro-magnetic which is sought pulse. has

field to be

has

a detrimental by the

promoted of

application to due promote to the

the

magnetic

Use not at

PEMF d e v i c e s successful beginning of

constriction frequency

been the of

ringing

a device is to

cycle. a method field, of

An o b j e c t treating wherein unipolar magnetic animal the field

the with

invention

provide magnetic

tissue is

a time-varying

generated pulse coil

by a s u b s t a n t i a l l y which is is passed to upon

rectangular, through the of the a

electro-magnetic coil of wherein a reverse the

biased pulse

prevent the

occurrence generated

polarity

decay

field. Another object of the invention field of and is to provide includes reverse polarity a device

which

will

generate to prevent

a magnetic generation of the of

which

circuitry pulse upon

a transient field. is

the

collapse

generated the to

A further device acting which as will be

object

invention form an

to

provide ice

a pack by

effective

electronic

a vaso-constrictor. In the preferred embodiment, a treatment pulse

generator transmitted provided the

controls to

the

frequency

of

magnetic treatment. is

pulses

which

are is of for

a patient that the

undergoing initial signal

Circuitry times that

such

frequency frequency,

ten

ultimate

treatment

thereby of

allowing signal device hertz. an

substantially frequency. output biasing is in

instantaneous This very is is

adjustment

treatment when the

particularly frequency in same

desirable ranges, the device as i.e.

low

0.1-20

circuit

provided of the

which the

induces treatment any

electrical through polarity collapse the

current

polarity

signal

treatment which

coils, may be

thereby

absorbing

reverse with

spikes of the

generated

simultaneously field. of

treatment and other

signal objects will is

generated and

These invention description drawings. and

advantages more fully

the

instant as the

the

method follows

become read in

apparent with the

which

conjunction

Description Fig. producing 1 is a block of

of

the of

Drawings the magnetic-field-

diagram the

therapy Fig.

device

instant diagram

invention. of a biasing circuit

2 is into

a schematic therapy

incorporated Fig. induced by

the an

device. of wave forms produced and

3 is

illustration without

the Fig.

device 4 is an

an o p e r a t i o n a l of wave

biasing forms

circuit. and

illustration with a biasing

produced

induced

by

the

device

circuit

operating.

Detailed Turning field-producing is 12. where 16. shown first therapy at

Description to Fig. 1, made

of

the

Drawings diagram to of a magneticinvention generator 14

a block

device 10.

according includes to

this

generally from

Device

10

a pulse

A signal it is

generator with 14

12 goes

frequency a time to

counter

compared

a signal transmits

from

base

generator

Frequency 18,

counter is

a signal in the

a frequency

display

which

a digital

display

preferred

embodiment. The generator generated therefore produced is frequency of the and signal in the generated preferred by pulse is

12 is at ten

adjustable, times to the

embodiment, It is

desired

output for

frequency. dividing the

necessary by g e n e r a t o r by

provide 12 to

means

frequency This

a usable, divider

treatment 20. 22. The

frequency. signal exits

accomplished 20 and

a frequency duty exit to

divider

enters

cycle the

control cycle volt

Two s i g n a l s signal signal, relation 12, is is of to transmitted a desired the

duty

control. 24. of

An u p d a t e A treatment a known by 26 generator is of off/on 26 is means, or, a switch.

a digital

meter and

treatment of

frequency, the signal 26.

frequency to

generated Amplifier the of

transmitted to a timer Timer The

an a m p l i f i e r 28 which

connected treatment.

controls

duration as an

28 may a l s o signal volt

be t h o u g h t leaving

treatment digital 30. volt

amplifier to a coil

transmitted treatment

to coil,

meter

24 and

Digital display provide 32. Thus

meter

24 t r a n s m i t s display as to 18 and the

a signal voltage

to

voltage 32

frequency information being

display and

complete of The

frequency to the

voltage coil. is

(amplitude)

pulses

transmitted 28 and

treatment what

components

12 to

32 c o m p r i s e

referred

to

herein

as

pulse

signal

generating

means. signal signal to in

A biasing treatment line coil 30 at

circuit such that

34 p r o v i d e s times of as the the

a maintenance polarity of the

31 r e v e r s e s 26.

from

treatment

signal

transmitted

by a m p l i f i e r

Turning schematic the signal the form. is

now to As the

Fig.

2,

biasing signal 31 and the

circuit leaves circuit circuit capacitor 40.

34

is

shown 26,

in

treatment line to

amplifier 34. when

routed

through signal The

A diode the

36

allows is at

treatment level. to

enter

signal the is

a high

signal

charges

38 and The signal

remainder then fed

passes into

variable

potentiometer has

op amp 42, signal 48,

which

a feedback through act the

loop

44 a s s o c i a t e d

therewith. transistors amplifier, coil 30.

The

next which

passes

Darlington-configured as a series pass treatment

46 and providing

together between

a buffer

op amp and

Capacitors preventing the In cycle. The biasing

50 and

52 a c t from

as

noise

suppressors, as an oscillator. pulse

circuit

acting

use,

pulse of

generator this

12

initiates is

a treatment and the

frequency divided

cycle

adjustable to the

frequency, generated frequency factor 20. of

by a known is

relation

originally on d i s p l a y 18. by a divider The

frequency, of 10, pulses in the

ultimately

displayed 12 by the

generated preferred

by g e n e r a t o r embodiment, to adjust and

is

divided

frequency voltage value which is

Amplifier

26 may be v a r i e d the treatment 32.

which is produced wave in

ultimately displayed

reaches by v o l t a g e 12 is

coil The

this

display

signal

by g e n e r a t o r the the frequency output

a substantially of 1-100 hertz. 0.1 of

unipolar-rectangular Frequency hertz to divider 100 hertz.

range to

20 c a u s e s

signal the

range is

from

Although

device

capable

producing

a much

higher

frequency, pulses in

it the

has

been

found range

that of

treatments 1-100 hertz defects

conducted are most

with beneficial to be for

frequency healing device of

promoting treated. The

animal

tissue as

sought ice to

may be used frequency stated,

an e l e c t r o n i c of of 0.1 the

pack

vaso-constriction

with

settings the device

5 hertz.

As p r e v i o u s l y invention magnetic this end, of is based is

instant electrowave form. To

on the the most

premise

that

a unipolar therapeutic signal

pulse the

effective

device

generates of

a treatment the

which

consists This is 22. in

solely referred causes

positive to herein device

portions as to

rectangular Duty

signal. cycle

a unipolar have

pulse.

control resulting signal.

the

a 50% d u t y

cycle,

thereby

a substantially duty cycles

square,

unipolar

pulsed

treatment

Other

may of The

course

be u s e d . has the capability the of delivering is generally voltages range coil. in an line high in

amplifier to

voltage the being results

at

up of

15 amps, volts, of

however, with the

output

range in

0.1-15 range

most

effective Such

the in

5.75-12.5 flux level

volts. of 4-22

a voltage at the

a magnetic Fig

gauss

3a r e p r e s e n t s unipolar field pulse is field

a 15 h e r t z reaches the

signal

measured coil,

31.

As each

treatment pulse

electro-magnetic the

produced. collapses. spike as coil

As the This as is

terminates, results 54. coil by in

electro-magnetic or

normally

a negative Fig. the

reverse polarity the wave

illustrated at in a sensing pulsed

3b r e p r e s e n t s magnetic shown state field in is Fig.

form in

induced

generated 3a.

30 by the still wave of to

treatment as-.a

signal steady or

Referring at 56, the

Fig. 3b,

reached, Upon

approaches

the pulse,

ground the

reference pulse

line.

initiation is formed as

a treatment large

induced impulse

initially is

a rather

negative spike 60.

58 which

immediately

followed

by a p o s i t i v e

This

ringing in

oscillates Fig. off 3c. as

for As the

approximately ringing by the induced

150

microseconds the 62. induced When the

as

depicted voltage treatment shown steady being at

subsides, curve voltage at

drops

depicted the

signal 64. The as

ceases, induced shown at

instantly returns next to

drops, a near-

as

voltage 66,

gradually to the

state,

prior

treatment

pulse

generated. The inclusion line of the in biasing Fig. circuit 4a. results in the

signal of the

form same

in

31 shown as the

A maintenance is

signal to in coil order

polarity

treatment

signal

transmitted is present about on is the in

treatment line 30. of 31,

coil as the

30 when result

a reverse of the

polarity of

signal the

collapse

field

Biasing 0.2 volts

circuit to coil

34 p r o v i d e s 30 when duty in the

a small

voltage, means field

generator the

a non30 31. 34

duty

cycle.

As the resulting of such

cycle

ends,

about in

coil line circuit as the

collapses, The to presence transmit

a reverse in of

polarity line the 31

signal "triggers" polarity

a signal component line in 34, the

a signal signal into

same

treatment polarity slightly depicted depicted

thereby line. above

offsetting The the to

the

reverse signal

signal elevates in in Fig. Fig.

present the 4a at 3a. form

maintenance reference negative

wave 68,

form as

line, spike 54

as

opposed

The wave a sensing operation, the when extreme the coil has

depicted 30 when as shown as is

in the at

Fig. biasing 70,

4b which circuit but

is is

induced in

in

by c o i l spikes,

72,

does in

not

exhibit 3b, as

spikes,

such

58 and not at

60 d e p i c t e d

Fig.

biasing ring

circuit still as

operating. the in peak, Fig. the 4c,

Although ring has

a high a much the has ring only

frequency smaller

occurs

amplitude,

depicted

than

does

generated

by a n o n - b i a s e d

signal,

and more

important,

one ring

reverse is

polarity

spike, to the of

as

shown

at

70.

The

duration

of

the

proportional The strength

treatment

frequency. signal by the 40 If, of is for 20% of is determined on in

the

maintenance

by the variable terms

biasing

circuit,

and 40. from

specifically Potentiometer 0 to to 100%.

setting

potentiometer device 40 output, is

calibrated instance, device

of

potentiometer a maintenance will the be fed to

adjusted 20% the 30 when collapses. signal

a value of

output, signal and

signal coil

strength the

the

treatment

treatment

signal

terminates 20% t h e

magnetic of the

field

A maintenance has spike, and been found

signal to by

value

treatment or

eliminate the

any of

negative value, magnetic field

negative

generated coil 30.

collapse

about

treatment use of the

A specific invention an a n i m a l device is

device

and m e t h o d which

of

the to The

exemplified which used to has,

by a t r e a t m e n t for an instance, electronic

may be a p p l i e d a bruise. As been able

limb

suffered ice have pack. not

may be

form known

previously promote occur pulse. may be applied. produce found to

mentioned,

PEMF d e v i c e s to high

to which

vaso-constriction the ringing coil,

due at

frequency of the of

wave

forms

during

the

beginning of 329 and of site.

treatment 22 gauge of 12.5 coil wire, volts will has the when been

A specific applied With to

formed

turns

a treatment

site

a voltage 3 hertz, This

a frequency at the

setting

the

22 g a u s s produce of

treatment

technique to reduce

sufficient The of

vaso-constriction same coil

severity used soft turns flux with

bruising.

and v o l t a g e

settings, to of

a frequency tissue

15 h e r t z

would

be e f f e c t i v e

treat size,

collagen and of

damage.

Various

combinations thereby

wire

voltages gauss

may be u t i l i z e d , at coil means 30.

producing

magnetic

0-60

While described, may be made it is

a preferred appreciate departing

embodiment of the from

of

the

invention and of

has

been

variations the spirit

modifications the invention.

without

1. treating magnetic generating

A magnetic-field-producing tissues with

therapy

device

for

animal field

a uni-directional, signal generating as

time-varying means for

comprising

pulse

a treatment unipolar, at

signal

characterized

having pulses a biasing of a

substantially known polarity

rectangular

electro-magnetic frequency and of

a predetermined relative to said

predetermined means

amplitude joined the

to

a reference

level, for

operatively when

generating is of

means, a reverse

producing, signal

treatment

signal the

polarity, of said flux

component signal, means

offsetting and for coil

reverse

polarity

portion to

said

treatment generating said to

means

operatively

joined

producing for use

a concentrated in at applying a treatment of claim duty claim the

magnetic flux

from

treatment

signal

so p r o d u c e d

tissue

undergoing 2. The

therapy

site. 1 wherein cycle. 1 wherein means unipolar said for pulses. said

therapy has

device

treatment

signal 3. The

a fifty

percent of

therapy includes

device

generating adjusting

means the 4.

amplitude

adjustment of the

predetermined The therapy means

amplitudes device is of

claim

3 wherein to vary the

said

amplitude

adjustment

adjustable 0.1-15 of

predetermined 5. means that and said

amplitude The

between device are

volts. 3 wherein said coil such

therapy means

claim

generating coil means

cooperatively a magnetic flux

constructed of 0 to

produces

60 g a u s s .

6. generating for

The

therapy further output

device includes signal

of an

claim

3 wherein

said generator

means an

adjustable pulses

pulse with a

generating

having

controllably operatively value having

variable joined to

known said

frequency, generator to the

frequency for

readout

means

displaying frequency, said

a frequency and generator in response pulses by t h e

a known

relation

known

frequency and to said said

divider amplitude output

means

operatively means

interposed for

adjustment a lower to known the

producing, signal

signal, equal

frequency known

having

with

a frequency

frequency

multiplied

previously-mentioned 7. generator the is The

relation. device of the claim 6 wherein said pulse of

therapy to

adjustable pulses

vary

predetermined hertz. animal tissue

frequency

unipolar 8.

between of

0.1-100

A method

treating

with

a timea

varying, signal

pulsed

electro-magnetic as having

field

comprising

generating

characterized

substantially of

unipolar,

rectangular

electro-magnetic

pulses

a predetermined flux by e n e r g i z i n g when a

frequency, producing a coil the with the is-of

a time-varying signal,

magnetic said

generated a reverse offsetting to

during

energizing, the coil and with

signal

polarity, the

biasing

signal the

component flux

reverse site.

polarity,

applying

magnetic 9.

a treatment of in of the claim the

The method a frequency The method in

8 wherein of 0.1

the to the to

generated 100 hertz.

signals

have 10.

range

claim range

8 wherein of 0.1

generated

pulses

have

amplitudes

15 v o l t s .

11. signal is

The to

method

of

claim

8 wherein

the

generated across the coil.

biased 12.

maintain of

a positive claim cycle

voltage the

The method have

8 wherein of fifty

generated

pulses

generally

a duty

percent.