U.S. patent number 3,828,769 [Application Number 05/336,783] was granted by the patent office on 1974-08-13 for method and apparatus for ultrasonic treatment of lower tissues simultaneous with heating of subcutaneous, outer muscle and lower tissues.
Invention is credited to Hal C. Mettler.
United States Patent |
3,828,769 |
Mettler |
August 13, 1974 |
METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF LOWER TISSUES
SIMULTANEOUS WITH HEATING OF SUBCUTANEOUS, OUTER MUSCLE AND LOWER
TISSUES
Abstract
An ultrasonic frequency electro-mechanical therapeutic method
and apparatus for treating an afflicted member, having skin,
subcutaneous outer muscle and lower tissues, of a patient's body,
the lower tissues including muscle, nerve, bone or joint tissues. A
therapeutic applicator has an electrically energizable crystal for
generating a mechanical energy wave and has a first pair of
substantially parallel sides spaced apart a distance determinative
of a first resonant frequency and a second side normal to the first
pair of sides determinative of a second resonant frequency of at
least 150 kHz selected for heating the lower tissues of a patient's
body. The applicator includes a metallic electrode on each of the
pair of sides, a housing in which the crystal is mounted and
protective coating covering at least one of the pair of sides and
forming an applicator side facing out of the housing. An ultrasonic
energy generating circuit is coupled across the metallic electrodes
and generates across the crystal an ultrasonic electrical signal
and thereby a mechanical vibratory energy wave in the crystal, both
having at least one frequency component equal to the second
resonant frequency. Means generates heat adjacent the applicator
side simultaneously with the mechanical vibratory energy and in the
subcutaneous and outer muscle tissues of a patient's body in the
afflicted member. The heat is sufficient to cause a heat rise in
the subcutaneous and outer muscle in a range of 1.degree. C to
24.degree. C.
Inventors: |
Mettler; Hal C. (Huntington
Beach, CA) |
Family
ID: |
23317653 |
Appl.
No.: |
05/336,783 |
Filed: |
February 28, 1973 |
Current U.S.
Class: |
601/2 |
Current CPC
Class: |
A61B
8/0858 (20130101); A61H 23/0245 (20130101); A61N
7/02 (20130101) |
Current International
Class: |
A61H
23/02 (20060101); A61B 8/08 (20060101); A61N
7/02 (20060101); A61N 7/00 (20060101); A61h
001/00 () |
Field of
Search: |
;128/24A,24.5,303.1,362,65,24.2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Christie, Parker & Hale
Claims
What is claimed is:
1. A method of treating an afflicted member of a patient's body
comprising the steps of:
a. selecting such an afflicted member having skin, subcutaneous,
outer muscle and lower tissues, the lower tissues including inner
muscle, nerve, bone or joint tissues;
b. generating heat in the subcutaneous and outer muscle tissues at
a localized area of the patient's body in the afflicted member,
causing an increase in temperature therein in the range of
1.degree. C. to 24.degree. C.;
c. generating an ultrasonic mechanical vibratory energy wave having
a frequency of at least 150 kHz; and
d. simultaneously with the step of generating heat coupling said
mechanical vibratory energy wave to the same localized area.
2. The method of claim 1 including the step of applying an ointment
coupling agent to the skin of the afflicted member at the localized
area and utilizing the coupling agent for coupling the mechanical
vibratory energy wave.
3. The method of claim 1 wherein the step of generating heat
comprises the step of applying surface heat to the skin in the
localized area.
4. The method of claim 3 wherein the step of generating heat
comprises the step of applying surface heat to the skin in the
localized area in the range of 5.degree. C. to 24.degree. C. above
skin temperature.
5. The method of claim 4 wherein the step of generating the first
named mechanical vibratory energy wave comprises the step of
generating energy waves having a frequency in the range of 150 kHz
to 500 kHz.
6. The method of claim 1 wherein the step of generating heat
comprises the steps of generating a further mechanical vibratory
energy wave moving in a direction substantially parallel to the
surface of the skin and coupling the same to the subcutaneous and
outer muscle tissues in the afflicted member, the further energy
wave being selected to generate heat in the subcutaneous and outer
muscle tissues and the first mentioned energy wave being selected
and extending in a direction substantially normal to the further
energy wave to thereby generate heat at the lower tissues, the
combination of energy waves providing a continuous heating effect
through the subcutaneous and outer muscle and lower tissues in the
localized area.
7. The method of claim 6 including the step of separately
controlling the energy level of one of the energy waves.
8. Ultrasonic frequency electro-mechanical therapeutic apparatus
for treating an afflicted member, having skin, subcutaneous outer
muscle and lower tissues, of a patient's body, the lower tissues
including inner muscle nerve, bone or joint tissues, the
combination comprising:
a. therapeutic applicator comprising:
1. an electrically energizable crystal for generating mechanical
energy having a first pair of substantially parallel sides spaced
apart a distance determinative of a first resonant frequency and a
second side normal to said first pair of sides determinative of a
second resonant frequency of at least 150 kHz selected for heating
the lower tissues,
2. a metallic electrode on each of said pair of sides,
3. a housing in which said crystal is mounted,
4. a protective coating covering at least one of said pair of sides
and forming an applicator side facing out of said housing,
b. ultrasonic energy generating circuit coupled across the metallic
electrodes and generating across said crystal an ultrasonic
electrical signal and thereby mechanical vibratory energy, both
having at least one frequency component equal to said second
resonant frequency; and
c. means for generating adjacent said applicator side
simultaneously with said mechanical vibratory energy, and in the
subcutaneous and outer muscle tissues in the afflicted member
sufficient heat to cause a heat rise therein in the range of
1.degree. C. to 24.degree. C.
9. The apparatus of claim 8 wherein said means for generating heat
comprises a heat radiator.
10. The apparatus of claim 9 wherein said heat radiator is
positioned at said applicator side so as to be positioned in
between the afflicted member and applicator side.
11. The apparatus of claim 8 wherein said at least one side of said
crystal has an area in the range of 2 to 15 cm.sup.2 thereby
causing an ultrasonic mechanical vibratory energy wave to be
formed, moving substantially parallel with said applicator side and
thereby forming said means for generating heat in the subcutaneous
layer.
12. The apparatus of claim 11 comprising cement connected between
said crystal and housing the cement and housing providing a space
adjacent substantially all of said pair of sides to permit free
movement of the applicator side in a direction normal to said pair
of sides of the crystal to thereby cause a uniform distribution of
energy across said applicator side.
13. The apparatus of claim 12 wherein said at least one side of
said crystal has an area in the range of 2 to 15 cm.sup.2 thereby
causing an ultrasonic mechanical vibratory energy wave to be
formed, moving substantially parallel with said applicator side and
thereby forming said means for generating heat in the subcutaneous
and outer muscle tissues.
14. The generator of claim 8 wherein said second resonant frequency
is in the range of 150 to 500 kHz.
15. The apparatus of claim 14 wherein said heat radiator is
positioned at said applicator side so as to be positioned in
between the afflicted member and applicator side.
16. The generator of claim 11 wherein said second resonant
frequency is in the range of 150 to 500 kHz.
17. The generator of claim 16 wherein said generating means
comprises controllable signal generating means for controlling the
level of mechanical vibratory energy generated at said first
frequency.
18. The generator of claim 8 wherein said generating means
generates an electrical signal having both said first and second
resonant frequencies, the first resonant frequency being selected
to generate said localized heat in the subcutaneous and outer
muscle tissues.
19. Ultrasonic frequency electro-mechanical therapeutic apparatus
for treating an afflicted member, having skin, subcutaneous outer
muscle and lower tissues, of a patient's body, the lower tissues
including inner muscle, nerve, bone and joint tissues, the
combination comprising:
a. therapeutic applicator comprising:
1. an electrically energizable transducer having an applicator side
for generating mechanical energy, the transducer generating a first
mechanical vibratory energy wave traveling in a direction normal to
said applicator side and at a frequency of at least 150 kHz
selected for heating the lower tissues,
2. a housing in which said transducer is mounted,
b. ultrasonic energy generating circuit coupled to the transducer
for exciting the transducer with an electrical signal and thereby
causes a mechanical vibratory energy wave, both having at least one
frequency component equal to said frequency of at least 150 kHz;
and
c. means for generating adjacent said applicator side
simultaneously with said mechanical vibratory energy wave, and in
such subcutaneous and outer muscle tissues sufficient heat to cause
a heat rise therein in the range of 1.degree. C. to 24.degree.
C.
20. The generator of claim 19 wherein said second resonant
frequency is in the range of 150 to 500 kHz.
21. The apparatus of claim 12 wherein said means for generating
heat comprises a heat radiator.
22. The generator of claim 19 wherein said generating means
generates an electrical signal having both said first and a second
resonant frequency, the second resonant frequency being selected to
generate said localized heat in the subcutaneous and outer muscle
tissues.
23. The generator of claim 22 wherein said generating means
comprises controllable signal generating means for controlling the
level of mechanical vibratory energy generated at said second
frequency.
24. Ultrasonic frequency electro-mechanical therapeutic apparatus
for treating an afflicted member, having skin, subcutaneous outer
muscle and lower tissues, of a patient's body, the lower tissues
including inner muscle, nerve bone, or joint tissues, the
combination comprising:
a. therapeutic applicator comprising:
1. an electrically energizable crystal for generating mechanical
energy having a first pair of substantially parallel sides spaced
apart a distance determinative of a first resonant frequency and a
second side normal to said first pair of sides determinative of a
second resonant frequency of at least 150 kHz selected for heating
the lower tissues,
2. a metallic electrode on each of said pair of sides,
3. a housing in which said crystal is mounted,
b. ultrasonic energy generating circuit coupled across the metallic
electrodes and generating across said crystal an ultrasonic
electrical signal and thereby mechanical vibratory energy, both
having at least one frequency component equal to said second
resonant frequency; and
c. means for generating adjacent said applicator side
simultaneously with said mechanical vibratory energy, and in the
subcutaneous and outer muscle tissues in the afflicted member
sufficient heat to cause a heat rise therein in the range of
1.degree. C. to 24.degree. C.
Description
BACKGROUND OF THE INVENTION
This invention relates to ultrasonics and, more particularly, to a
method for ultrasonic treatment of a patient's afflicted
member.
Ultrasonic energy is accepted by the medical profession as
penetrating more deeply, and thus creating deeper heat in human and
animal bodies than any other modality. An ultrasonically conductive
vehicle such as oil or other aqueous couplant is used to conduct
the ultrasonic energy to the patient's member.
Attempts have been made to use ultrasonic treatment at frequencies
as low as 800 kHz (see page 294 of "Electrotherapy and light
Therapy" by Kovacs; Lee and Fibiger, 1949). However, in general,
treatment below 800 kHz has not passed the experimental stage
because of the sharp pain developed in the bone area. This sharp
pain is not experienced with therapeutic treatment of higher
frequencies. It is now believed that the sharp pain at lower
frequencies comes about because applicators used have a
piezoelectric crystal transducer which concentrates the ultrasonic
energy over a small area at the center of the applicator.
Applicant built an ultrasonic generator which generates signals at
90 kHz using a crystal which emits ultrasonic energy in a
substantially uniform pattern over the piezoelectric crystal.
Applicant's generator was tested on a patient at a leading
university and it was discovered that strikingly enhanced
therapeutic efforts are obtained at 90 kHz using a crystal which
emits ultrasonic energy in a substantially uniform pattern over the
piezoelectric crystal. Centrally concentrated energy from crystals
used prior to applicant's aforementioned device was obtained
because the crystals had mechanical restraints. These mechanical
restraints are eliminated by mounting the crystal such as that
described in applicant's U.S. Pat. No. Re. 25,657. Also at lower
frequencies thicker crystals are used, allowing the crystal to be
supported by a thin diaphragm to which the crystal is affixed and
still obtain a substantially uniform energy distribution.
With a substantially uniform energy pattern at 90 kHz it was found
that greatly enhanced therapeutic effects are obtained because
cortisol (an anti-inflammatory substance) is drawn in much larger
quantities to the afflicted area at 90 kHz than at 1 mHz. This is
true when the externally applied conductive vehicle is the source
of the cortisol or when a body organ of the patient is the source
of the cortisol. In the latter case, large amounts of cortisol are
drawn to the afflicted area with treatment at 90 kHz, while none is
drawn by 1 mHz. Additionally, treatment at 90 kHz was found to
produce a much greater beneficial physiologic effect on nerve
tissue than on muscle tissue. Many of the advantages of using 90
kHz are contained in a prior art article entitled "Ultrasonic
Movement of Cortisol into Pig Tissue" appearing in the American
Journal of Physical Medicine, Vol. 44, No. 1, pp. 20-25. Equipment
for the experiments reported in this article was donated by the
applicant's company, Mettler Electronics Corp.
However, treatment at 90 kHz proved impractical because of a noise,
audible only to the patient, set up in the patient's body. The
objectionable noise is highly irritating and is even more
pronounced when treating the upper back or the head region. The
noise is a screeching noise and makes treatment unbearable. As a
result, treatment at 90 kHz has never been practical.
SUMMARY OF THE INVENTION
Briefly, a preferred method of treating an afflicted member of a
patient's body according to the present invention involves the
following steps: selecting an afflicted patient's member having
skin, subcutaneous outer muscle and lower tissues, the lower
tissues including muscle, nerve, bone and joint tissues; generating
heat in the subcutaneous and outer muscle tissues at a localized
area of the patient's body in the afflicted member, causing an
increase in temperature therein in the range of 1.degree. C to
24.degree. C; generating an ultrasonic mechanical vibratory energy
wave having a frequency of 150 kHz or greater; and simultaneously
with the step of generating heat, coupling the mechanical vibratory
energy wave to the same localized area to which heat is
applied.
It has been found that such a method produces greatly enhanced
therapeutic results in that much larger amounts of cortisol is
driven from the surrounding tissue into the critical tissues, such
as muscle, nerve, bone and joint tissues. Such a method also
enables externally applied cortisol in ointment form to be driven
in much greater quantities into the critical tissues. A report on
the unusual and greatly enhanced therapeutic values is disclosed in
a publication within the last year in the Americal Journal of
Medicine, copyright 1972 by The Williams & Wilkins Co., Vol.
51, No. 2, in an article entitled "Effects of Ultrasonic Frequency
on Phonophoresis of Cortisol into Swine Tissues" by Drs. Griffin
and Touchstone.
Preferably, the foregoing method according to the invention is
supplemented by applying an ointment coupling agent to the skin at
the localized area and utilizing the coupling agent for coupling
the mechanical vibratory energy wave thereby providing greater
conductivity of the energy wave to the afflicted member.
In one embodiment of the present invention, the step of generating
heat comprises the step of applying surface heat at the skin layer
in the localized area.
According to a further preferred embodiment, the step of generating
heat comprises the step of applying surface heat to the skin in the
localized area in the range of 1.degree. C. to 24.degree. C above
skin temperature.
According to an additional preferred embodiment of the invention,
the step of generating the first named energy wave comprises the
step of generating an energy wave having a frequency in the range
of 150 kHz to 500 kHz wherein greater cortisol is driven to the
lower tissues without requiring surface heat.
According to a still further preferred embodiment of the invention,
the step of generating heat includes the steps of generating a
further mechanical vibratory energy wave moving in a direction
substantially parallel to the surface of the skin and coupling such
wave to the subcutaneous and outer muscle tissue. The further
energy wave is selected to generate heat in the subcutaneous and
outer muscle tissue and the first mentioned energy wave is selected
and extends in a direction substantially normal to the direction of
the further energy wave to thereby generate heat at the lower
tissues. Significantly, the combination of the two energy waves
provides a substantially continuous heat throughout the
subcutaneous outer muscle and lower tissues in the localized area.
Greatly enhanced therapeutic results are obtained in that by such
continuous heating, greater amounts of cortisol are driven,
naturally from the body or from externally applied sources, into
the critical lower tissues.
A further preferred embodiment of the invention involves the step
of separately controlling the energy level of the first named
energy wave, thereby enabling the level of heat in the subcutaneous
and outer muscle tissue to be separately controlled.
According to another embodiment of the invention, there is an
electro-mechanical therapeutic apparatus for treating an afflicted
member as already defined. Therapeutic apparatus comprises an
electrically energizable transducer having an applicator side, the
transducer generating a first mechanical vibratory energy wave
traveling in a direction normal to the applicator side and at a
first frequency of at least 150 kHz selected for heating the lower
tissues. In the therapeutic applicator there is provided a housing
in which the transducer is mounted. An ultrasonic energy generating
circuit is coupled to the transducer for exciting the transducer
with an electrical signal and thereby causes a mechanical vibratory
energy wave, both having at least one frequency component equal to
the first frequency. Means is provided for generating adjacent the
applicator side simultaneous with the mechanical vibratory energy
wave, and in such subcutaneous and muscle tissues sufficient heat
to cause a heat rise therein in the range of 1.degree. C. to
24.degree. C.
According to the preferred apparatus, the therapeutic applicator
comprises an electrically energizable crystal having a first pair
of substantially parallel sides spaced apart a distance
determinative of a first resonant frequency and a second side
normal to the pair of sides determinative of a second resonant
frequency of at least 150 kHz. The second resonant frequency is
selected for penetrating and heating the lower tissues. Included in
the therapeutic applicator is a metallic electrode on each of the
pair of crystal sides and a housing in which the crystal is
mounted. A protective coating covers at least one of the pair of
sides and forms an applicator side facing out of the housing. An
ultrasonic energy generating circuit is coupled across the metallic
electrodes and generates across the crystal an ultrasonic frequency
electrical signal and thereby a mechanical vibratory energy wave.
The signal and mechanical vibratory energy wave have at least one
frequency component equal to the second resonant frequency of the
crystal. Means generates at the applicator side, simultaneously
with the mechanical vibratory energy wave, and in the subcutaneous
and outer muscle tissues, sufficient heat to cause a heat rise
therein in the range of 1.degree. C. to 24.degree. C.
According to one embodiment of the invention, the means for
generating heat comprises a heat radiator.
According to a further preferred embodiment of the invention, the
heat radiator is positioned at the applicator side so as to be
positioned in between the afflicted member and applicator side.
According to another preferred embodiment of the invention, the at
least one side of the crystal has an area in the range of 2 to 15
centimeters square (cm.sup.2), thereby causing an ultrasonic
mechanical vibratory energy wave to be formed moving substantially
parallel with the applicator side and thereby forming the means for
generating heat in the subcutaneous and outer muscle tissues.
Preferably, in order to generate a uniformly distributed mechanical
vibratory field across the applicator side, cement connects the
crystal and housing and the housing and cement are arranged so as
to provide a space adjacent substantially all of the pair of sides
to allow free movement of the applicator side in a direction normal
to the pair of sides of the crystal.
A further preferred embodiment of the invention is one wherein the
second resonant frequency is in the range of 150 to 500 kHz,
allowing the driving of cortisol to lower muscle tissues without
requiring surface heat.
According to a further preferred embodiment of the invention, the
generating means forms an electrical signal having both first and
second resonant frequencies and the first resonant frequency is
selected to generate the localized heat in the subcutaneous and
outer muscle tissues.
According to a preferred arrangement of the preceding preferred
embodiment, the generating means has a controllable signal
generating circuit for controlling the level of mechanical
vibratory energy at the first frequency.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a schematic and perspective view of an ultrasonic
frequency electro-mechanical therapeutic apparatus and embodying
the present invention;
FIG. 2 is a section view of the therapeutic applicator of FIG. 1
taken along the lines 2--2;
FIG. 3 is a cross-sectional view of a therapeutic applicator
according to an alternate embodiment of the invention;
FIG. 4 is an alternate embodiment of the invention wherein a
surface heat radiator is positioned in between the therapeutic
applicator and the afflicted member being treated;
FIG. 5 is a perspective view of a crystal used to illustrate the
principles of the present invention; and
FIG. 6 is a schematic representation of an alternate embodiment of
the present invention wherein the separate signal generators are
used to apply two different frequencies to the crystal so that the
level of power at the two frequencies can be independently
varied.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 is a schematic and perspective view of an ultrasonic
frequency electro-mechanical therapeutic apparatus and embodies the
present invention. The apparatus of FIG. 1 is for treating an
afflicted member, having skin, subcutaneous, outer muscle and lower
tissues of a patient's body. The lower tissues include inner
muscle, nerve, bone and joint tissues. The patient may be a human
or an animal. Specifically, the apparatus is for driving cortisol
to the lower tissues from other parts of the body or from cortisol
applied externally to the skin. Other elements beside cortisol may
be driven into the lower tissues within the broader concept of the
invention.
Included is a therapeutic applicator 10. The therapeutic applicator
10 includes a grounded metallic housing 12 connected to an
energizing circuit 14. The energizing circuit 14 is a conventional
electronic circuit well known in the crystal art for applying an
ultrasonic frequency electrical signal across a piezoelectric
crystal. Mechanically mounted in the housing 12 is a crystal 16.
The crystal 16 is a disk-shaped piezoelectric crystal as typified
by FIG. 5, having a pair of substantially parallel circular
surfaces 18 and 20 separating the surfaces 18 and 20, a circular
side 22. A thin metallic electrode 24 covers the sides 18 and 22. A
second thin metallic electrode 26 is positioned in a circular area
(only part being shown in FIG. 2), near the center on the circular
side 20. Two sides of the energizing circuit 14 are connected
across the electrodes 24 and 26 as described hereinafter to thereby
apply across the crystal 16 an ultrasonic frequency electrical
signal causing the crystal to generate a mechanical vibratory
energy wave. The electrodes 24 and 26 are silver or other metals
vacuum deposited or securely affixed to the crystal by other
processes well known in the crystal art.
A protective coating material 26, such as plastic or metallic
substances, extends over the exposed portion of the electrode 24
and, in particular, forms an applicator side 32. The electrode 24
is connected to the grounded metallic housing 12 by an electrically
conductive adhesive 28 and 30. The electrically conductive adhesive
30 extends around the corner formed by the surface 20 of the
crystal and the inside surface of the housing 12 to thereby provide
a mechanical connection therebetween. However, it should be noted
that the housing overlaps the side 32 only a short distance and the
adhesive 30 only extends a very short distance over the bottom
surface of the crystal 20, leaving free space adjacent
substantially all of the sides 18, 20 and 22 to prevent restriction
of movement of the crystal allowing a substantially uniform
distribution of mechanical vibratory energy across the applicator
side. Other details of such a mounting are disclosed and described
in applicant's U.S. Pat. Re. No. 25,657, the contents of which are
incorporated herein by reference.
The energizing circuit 14 (shown only in FIG. 2) has conductors 31
and 31', 31 being grounded, which are soldered, welded or otherwise
affixed to the housing 12 and the electrode 26, respectively.
Turn now to the typical example of the crystal 16 shown in FIG. 5.
The parallel sides 18 and 20 are spaced apart a distance d1
determinative of a first resonant frequency f1. The side 22 defines
a diameter d2 or a dimension that is determinative of a second
resonant frequency f2. According to the present invention, the
resonant frequency f1 is at least 150 kHz which is selected for
heating the lower tissues of a patient's body without causing the
undesirable noise irritations. According to a preferred embodiment
of the present invention, the frequency f1 is in the range of 150
to 500 khz which achieves subcutaneous heating merely by selecting
the proper crystal size without the need of applying surface heat.
This feature will be explained in more detail hereinafter.
The energizing circuit 14 is coupled across the electrodes 24 and
26 and provides an ultrasonic frequency electrical signal f1 across
the crystal, thereby causing a mechanical vibratory energy wave
from the crystal having at least one ultrasonic frequency component
equal to the resonant frequency f1.
According to the invention, means is provided for generating heat
adjacent the applicator side 32 of the crystal, simultaneously with
the mechanical vibratory energy wave. The heat is generated in the
subcutaneous and outer muscle tissues and is sufficient to cause a
heat rise therein in the range of 1.degree. C. to 24.degree. C.
Preferably, the heat rise is in the range of 5.degree. C. to
24.degree. C. The heat rise formed at the skin surface is in the
range of 5.degree. C. to 24.degree. C. The mechanical vibratory
energy wave created by the resonant frequency f1 acts in an axial
direction of the crystal, thereby penetrating to the lower tissues
where the inner muscle, nerve, bone and joint tissues lie. The heat
generated in the subcutaneous and outer muscle tissues, together
with heat created by the ultrasonic frequency f1 at lower tissues,
causes a continuous temperature rise in the subcutaneous outer
muscle and lower tissues. This continuous heat in combination with
the agitation created by the ultrasonic signal at frequency f1
causes cortisol to be driven to the critical lower tissues.
Referring to FIG. 4, one embodiment of the invention is shown for
generating the heat and comprising a conventional heat pad 34. It
will be noted that the heat pad or radiator 34 is positioned at the
applicator side 32 in between the applicator side 32 and the
afflicted member to be treated.
According to another and a preferred embodiment of the invention, a
crystal 16, as shown in FIGS. 1 and 2, is used having parallel
sides 18 and 20, each with an area in the range of 2 to 15
cm.sup.2. By providing such area on the crystal with the
aforementioned ranges in frequency, it is a known scientific fact
that an ultrasonic mechanical vibratory energy wave is formed,
moving substantially parallel with the applicator side 32 and these
energy waves generate heat in the subcutaneous and upper muscle
tissues. Thus, according to the preferred embodiment of the
invention, the shape of the crystal and the energizing circuit 14
form the means for generating heat in the subcutaneous and outer
muscle tissues.
Refer now to the alternate embodiment of the invention shown in
FIG. 6. In the alternate embodiment of the invention shown in FIG.
6, a parallelepiped crystal 36 is shown having parallel spaced
apart sides 38 and 39 separated by parallel spaced apart sides 40
and 42. The spacing between sides 38 and 39 is a distance which
determines a first resonant frequency of the crystal and the
spacing between the sides 40 and 42 determines a second resonant
frequency of the crystal. Provided on each of the parallel sides 38
and 39 is a metallic electrode 44 affixed in a well known manner in
the crystal art. (The electrode 44 on the surface 40 not being
shown). Electrodes 41 are affixed on the sides 39 and 42 in the
same manner as electrodes 44. (The electrode on side 42 not being
shown).
Variable power level electrical signal generator 46 is connected
across the electrodes 44 and variable power level electrical signal
generator 48 is connected across the electrodes 41. The frequency
of the signal formed by the generator 46 is equal to the resonant
frequency between sides 38 and 39 and the frequency of the signal
formed by generator 48 is equal to the resonant frequency
determined by the spacing between sides 39 and 42. The amount of
power delivered by each of the generators 46 and 48 is variable. As
a result, it is possible to control the power level of the
mechanical vibratory energy wave generated at one frequency
independently of the level generated at the other frequency. The
parallelepiped crystal illustrated in FIG. 6 may be mounted in the
manner illustrated in the above-mentioned U.S. Pat. Re. No. 25,657.
The applicator side of the crystal may be the side 38 with a
protective coating (not shown) covering the applicator side.
The sides 38 and 39 are determinative of a resonant frequency of at
least 150 kHz and preferably of a resonant frequency in the range
of 150 to 500 kHz for the reasons discussed above. The mechanical
energy wave determined by the resonant frequency between sides 39
and 42 moves in a direction parallel with side 38 and heats the
subcutaneous and outer muscle tissues whereas the mechanical energy
wave determined by the resonant frequency between sides 38 and 40
moves normal to side 38 and heats and treats the lower tissues.
In the embodiment shown in FIG. 6, the generator 48 and the crystal
36 form the means for generating adjacent the applicator side,
simultaneously with the mechanical vibratory energy, and in the
subcutaneous layer, the proper amount of heat to cause a heat rise
in the subcutaneous and outer muscle in the range of 1.degree. C.
to 24.degree. C. and a rise in skin temperature in the range of
5.degree. C. to 24.degree. C. This is accomplished by selecting a
dimension between sides 40 and 42 so as to determine a resonant
frequency of the crystal to generate the required subcutaneous and
outer muscle tissues heat.
Instead of providing separate electrodes on separate sides, the
generators may be connected across electrodes on only two sides.
For example, the electrodes may be split into two electrically
separate electrodes on one side and the two generators connected
between a single electrode on one side and the separated electrodes
on the other.
The separate generators of FIG. 6 may be replaced with a single
generator which provides a signal across two sides having two
frequencies. One example of such a generator is disclosed in
applicant's U.S. Pat. No. 3,180,626 which is incorporated herein by
reference.
FIG. 3 shows an alternate embodiment of the applicator 10 according
to the invention and illustrates an alternate way in which the
disk-shaped crystal 16 shown in FIGS. 2 and 5 may be mounted.
Specifically, the crystal 16 shown in FIG. 3 has an electrode 26
identical to that shown in FIG. 2 with an alternate electrode 50
which completely covers the side 18, the side 22 and slightly into
the side 20. The corner of the metallic electrode 50 is wedged into
a metallic housing 52. The housing 52 has a flared annular area 54
which extends away from the side of the electrode 50 adjacent the
side 22 of the crystal. Electrically conductive epoxy 56 is
positioned in the flared annular area between the electrode 50 and
the housing 52 to rigidly connect the two together. A plastic
covering 58 extends over the exposed portion of the electrode 50. A
coaxial cable 60 from an energizing circuit such as 14 has a center
wire 62 connected to the electrode 26 and a grounded shield wire 64
which is soldered to the metallic housing 52.
Preferably, the crystals shown in the drawings are of a barium
titanite material. However, within the broader concepts of the
invention, the crystal may be any one of a number of different
types of crystals which, when electrically energized with an
ultrasonic frequency electrical signal, will generate ultrasonic
mechanical vibratory energy. For example, the crystal may be lead
zirconate.
Within the broader concepts of the present invention, the crystal
may take on other shapes besides disk shape and parallelepiped
shape. For example, crystal may be oval-shaped.
It should also be understood that within the very broad concepts of
one embodiment of this invention that the heating means may take
the form of an electrical signal generator together with a crystal
having a low power factor, thereby generating sufficient heat to
heat the subcutaneous layer within the prescribed heat range.
The broader concepts of the invention involve other types of
electrical to mechanical transducers for generating ultrasonic
mechanical energy waves. For example, electromagnetostrictive
apparatus such as ferrite or nickel may be used in place of a
crystal as the transducer, provided they are designed to provide
similar characteristics to those described hereinabove.
It should also be noted that the range of resonant frequency of 150
kHz to 500 kHz is a preferred range and the upper limit of 500 kHz
is required in those situations where a separate heat radiator is
not provided for applying the heat. In the absence of a separate
heat radiator, it has been found that the improved biological
effects diminish and essentially no cortisone is developed in the
lower tissues when the frequencies reach 800 kHz. However, when a
separate radiator is used, improved biological effects are achieved
at even higher frequencies of ultrasonic mechanical vibratory
energy waves.
According to the foregoing teachings, the following steps form a
method of treating an afflicted member of a patient's body
according to the present invention: selecting an afflicted member
having skin, subcutaneous, outer muscle and lower tissues.
Generating heat in the subcutaneous and outer muscle tissues at a
localized area of the patient's body in the afflicted member,
causing an increase in temperature in the subcutaneous and outer
muscle tissues in the range of 1.degree. C. to 24.degree. C. It is
important that the heat be applied at a localized area since with
general application of heat and ultrasound, it is not possible to
cause the increased biological effects at the critical lower
tissues of interest. The steps also include the step of generating
an ultrasonic mechanical vibratory energy wave having a frequency
of at least 150 kHz. Simultaneously with the step of generating
heat, the energy wave is coupled to the same localized area as the
heat is applied.
It is important that the mechanical energy waves moving parallel
with the applicator surface (i.e. surface 32 of FIG. 2) be coupled
to the afflicted member. In order to improve the coupling of the
mechanical vibratory energy, preferably an aqueous ointment
coupling agent such as oil or water base materials, is applied to
the skin of the afflicted member at the localized area and is
utilized for coupling the mechanical vibratory energy to the
afflicted member. The ointment may contain the external cortisol or
other medicine.
One form of generating the heat includes the step of applying
surface heat to the skin in the localized area.
Preferably the step of applying surface heat to the skin in the
localized area includes the step of applying heat in the range of
5.degree. C. to 24.degree. C. above skin temperature.
According to a preferred embodiment of the invention, the first
named energy wave has a frequency in the range of 150 kHz to 500
kHz.
In place of the separate heat radiator, the step of generating the
heat may involve the step of generating a further mechanical
vibratory energy wave moving in a direction substantially parallel
to the surface of the skin and coupling such mechanical vibratory
energy wave to the subcutaneous and outer muscle tissues in the
afflicted member, such as by direct contact with or without a
coupling ointment. This procedure as described hereinabove may be
accomplished by selecting the correct applicator surface area for
the crystal or by energizing the crystal with signals having
different frequencies. The mechanical vibratory energy wave is
selected to generate heat in the subcutaneous layer and extend in a
direction which is substantially normal to the surface of the skin.
Thus, the combination of the two energy waves provide substantially
uniform heating through the subcutaneous and lower tissue layers in
the localized area.
Preferably, the energy level of one of the energy waves is variable
and controlled to thereby generate the proper amount of heat in the
subcutaneous and outer muscle tissue.
Although an exemplary embodiment of the invention has been
disclosed for purposes of illustration, it will be understood that
various changes, modifications and substitutions may be
incorporated in such embodiment without departing from the spirit
of the invention as defined by the claims appearing
hereinafter.
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