U.S. patent application number 10/775475 was filed with the patent office on 2004-11-18 for rf diathermy and faradic muscle stimulation treatment.
This patent application is currently assigned to EHTI Medical Corporation. Invention is credited to Bingham, James B., Olsen, Richard G..
Application Number | 20040230226 10/775475 |
Document ID | / |
Family ID | 21945768 |
Filed Date | 2004-11-18 |
United States Patent
Application |
20040230226 |
Kind Code |
A1 |
Bingham, James B. ; et
al. |
November 18, 2004 |
RF diathermy and faradic muscle stimulation treatment
Abstract
An RF diathermy coil assembly, including a generally elastically
deformable patient conforming garment and a conductive coil secured
to the garment. The conductive coil having a woven wire
construction such that the coil can deform as the garment
elastically deforms. The RF diathermy coil assembly can be used for
wound healing in conjunction with muscle stimulation.
Inventors: |
Bingham, James B.; (New
Braunfels, TX) ; Olsen, Richard G.; (Pensacola,
FL) |
Correspondence
Address: |
David D. Bahler, Esq.
FULBRIGHT & JAWORSKI L.L.P.
Suite 2400
600 Congress Avenue
Austin
TX
78701
US
|
Assignee: |
EHTI Medical Corporation
The United States of America, as Represented by the Secretary of
the Navy
|
Family ID: |
21945768 |
Appl. No.: |
10/775475 |
Filed: |
February 10, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10775475 |
Feb 10, 2004 |
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09616769 |
Jul 14, 2000 |
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6735481 |
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09616769 |
Jul 14, 2000 |
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09046856 |
Mar 24, 1998 |
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6094599 |
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Current U.S.
Class: |
607/3 |
Current CPC
Class: |
A61N 1/403 20130101;
A61N 1/0484 20130101 |
Class at
Publication: |
607/003 |
International
Class: |
A61N 001/18 |
Claims
What is claimed is:
1. An elastic wire assembly, comprising: a non-conductive elastic
core; a woven conductor secured to the core; and a non-conductive
elastic sheath over the woven conductor.
2. The elastic wire assembly in accordance with claim 1, wherein
the elastic core includes a plurality of polymer strands which can
be deformed elastically.
3. The elastic wire assembly in accordance with claim 1, wherein
the non-conductive elastic sheath includes a woven fabric.
4. The elastic wire assembly in accordance with claim 1, wherein
the wire assembly can stretch elastically approximately 30% of the
wire's relaxed length.
5. The elastic wire assembly in accordance with claim 1, wherein
the electrical conductivity of the wire assembly remains
approximately constant as the wire assembly is stretched
elastically.
6. An RF diathermy coil, comprising: a generally elastically
deformable patient-conforming garment; and a conductive coil
secured to the garment, the conductive coil having a woven wire
construction such that the coil can be deformed as the garment
elastically deforms.
7. The RF diathermy coil assembly in accordance with claim 6,
further comprising a woven RF shield connected to the garment,
wherein the shield is disposed toward the exterior of the garment
relative to the majority of the length of the coil.
8. The RF diathermy coil assembly in accordance with claim 6,
wherein the conductive coil further comprises a non-conductive
elastic deformable core.
9. The RF diathermy coil assembly in accordance with claim 8,
wherein the elastic core includes a plurality of polymer strands
which can form elastically.
10. The RF diathermy coil assembly in accordance with claim 6,
wherein the coil further comprises a non-conductive elastically
deformable sheath over the woven wire.
11. The RF diathermy coil assembly in accordance with claim 10,
wherein the non-conductive sheath includes a woven fabric.
12. The RF diathermy coil assembly in accordance with claim 6,
wherein the garment includes a polymer foam.
13. The RF diathermy coil assembly, comprising: a primary coil,
including a plurality of windings, the primary winding being
connectable to a power source lead; a secondary coil including a
plurality of windings disposed proximate the primary coil; means
for tuning an RF field established by the windings.
14. The RF diathermy coil assembly in accordance with claim 13,
wherein the means for tuning is for tuning the field to the
resonant frequency of a patient's body part.
15. The RF diathermy coil assembly in accordance with claim 13,
wherein the means for tuning includes a balun.
16. The RF diathermy coil assembly in accordance with claim 15,
wherein the balun is connected to the primary coil.
17. The RF diathermy coil assembly in accordance with claim 13,
wherein the means for tuning includes a tuning capacitor.
18. The RF diathermy coil assembly in accordance with claim 17,
wherein the tuning capacitor is connected to the secondary
coil.
19. The RF diathermy coil assembly in accordance with claim 13,
wherein the secondary coil includes more windings than the primary
coil.
20. The RF diathermy coil assembly in accordance with claim 13,
further comprising a housing releasably connectable to the coils,
the means for tuning disposed within the housing.
21. The RF diathermy coil assembly in accordance with claim 20,
wherein the means for tuning include a tuning capacitor.
22. The RF diathermy coil assembly in accordance with claim 20,
wherein the means for tuning includes a balun.
23. A method of medical treatment, comprising the steps of:
providing an RF diathermy device including, an RF coil connected to
a patient wearable garment; providing a muscle stimulator including
a plurality of electrodes; placing the garment on the patient;
activating the RF coil device to warm a wounded patient's body part
to increase blood circulation therein; placing the electrodes
proximate the muscles at the wounded body part; and stimulating the
muscles of the patient at the body part to increase blood
circulation therein.
24. A method of medical treatment in accordance with claim 23,
wherein the device is applied to a wound.
25. A method of medical treatment in accordance with claim 23,
wherein the device is applied to a patient's tissue to treat
diabetic neuropathy.
26. A method of medical treatment in accordance with claim 23,
wherein the device is applied to a patient's wrist to treat Carpal
Tunnel Syndrome.
27. A method of medical treatment in accordance with claim 23,
wherein the device is applied to a patient's tissue to treat
Raynaud's disease.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to physical medicine treatment and
more specifically to RF diathermy and faradic muscle stimulation
treatment for wound healing and treatment of various conditions by
application of heat and/or muscle stimulation.
[0002] Applying heat to a wound has been recognized as a viable
treatment for wound healing. Electrical-pulse neuromuscular
stimulation has been used to aid in wound healing. In each case, it
is believed that blood flow and, consequently O.sub.2 flow to wound
tissue is increased. Increased blood flow and thus O.sub.2 flow to
the wound tissue is believed to be of substantial aid in wound
healing.
[0003] Resonant RF coil systems and specifically shortwave
diathermy, deep-heating modality (see, Lehman, supra) can be used
to provide warmth to the extremities. U.S. Pat. No. 4,527,550 to
Ruggera describes a coil designed for use under full wave operation
at coil wire-length resonance, designed to provide maximum muscle
healing. The Ruggera coil system was operated at whatever frequency
was determined to be the "resonant" frequency for the
body-limb/coil combination. It would thus have to be operated
within an electromagnetically shielded room in most instances in
order to meet FCC noise requirements.
[0004] U.S. Pat. No. 4,685,462 to Olsen describes an apparatus for
rewarming hypothermia victims. U.S. Pat. No. 5,160,828 to Olsen
discloses a device for warming the extremities of a subject, such
as a deep-sea diver, in a cold wet environment, so that the subject
can perform agile tasks in such an environment. The Olsen coil
systems were designed to be tuned to specific
"Industrial-Scientific-Medical" (ISM) frequencies and, therefore,
could be operated in free-space, and without shielding, without
environmental interference.
[0005] The use of electrical-pulsed neuromuscular stimulation has
been suggested as treatment for peripheral vascular insufficiency.
See Lehman, J. F., Therapeutic Heat and Cooling, Rehabilitation
Medicine Library (1990, 4th edition), p. 458; cf. U.S. Pat. No.
4,368,4.10 to Hance et al. (ultrasound); 4,791,915 to Barsotti
(ultrasound). Such neuromuscular stimulation can increase the flow
rates of blood and lymphatic fluid by both mechanical and
electrical means. The physical contractions mechanically "squeeze"
the muscles and blood vessels, and the application-of electrical
current pulses helps maintain the tonicity of the vessels. Although
neuromuscular stimulation alone produces some beneficial effects,
its effectiveness is limited.
[0006] Previously, a convenient device and method for shortwave
diathermy and/or neuromuscular stimulation had not been devised to
treat slow or non-healing wounds due to vascular insufficiency,
diabetic peripheral neuropathy, microangiography, microvascular
disease, or compression neuropathies such as Carpal Tunnel
Syndrome. Furthermore, most previous and related treatment were
designed for use by or under the immediate supervision of a
health-care practitioner.
SUMMARY OF THE INVENTION
[0007] The present invention pertains to a device and method for
wound treatment and treatment of various other conditions such as
diabetic peripheral neuropathy, microangiography, osteoarthritis,
microvascular disease, and/or compression neuropathies. A resonant
diathermy coil system for deep heating is provided in combination
with a muscle stimulator. RF heating of tissue can be accomplished
in conjunction with muscle stimulation. Alternatively, either
therapy, RF heating or muscle stimulation can be applied
independently. The device of the present invention includes
specially adapted components to accomplish the therapies as
described in more detail below.
[0008] In one embodiment of the present invention, an RF diathermic
coil assembly includes a primary coil. The primary coil includes a
plurality of windings that are ostensibly helical and connected to
a power source. The assembly also includes a secondary coil
including a plurality of windings disposed proximate the primary
coil. The purpose of the two coils is to provide a convenient
impedance-matching method between the cable-connected power source
(typically 50 ohms) and the resonant secondary coil with typical
end-to-end impedance of hundreds of ohms. Therefore, the secondary
coil preferably includes more windings than the primary coil. A
means for tuning the body-part-plus-coil system to resonance is
provided.
[0009] A means for tuning is necessary because various body parts
inside a given coil system to be diathermally heated present
different dielectric (capacitive) parameters and, as such, would
cause the resulting resonant frequency to vary slightly. Adjusting
the system to resonance can be accomplished by changing either the
inductance of the coils or the capacitance of the system, most of
which capacitance consists of body tissues inside the coils. Small
changes in coil inductance can be made either by changing the
helical length of the conductor or by changing other physical coil
characteristics such as diameter or pitch. Small changes in the
capacitance of the system are easily made by connecting a variable
capacitor with sufficient voltage rating within the range of
approximately 4 to 26 picofarads in parallel with the secondary
winding. The present invention makes use of the variable capacitor.
In some applications, a balun coil is added, close to the
diathermic coils, in series with the coaxial cable that connects to
the RF energy source. The purpose of the balun coil is to make the
distribution of RF tissue warming more uniform, symmetrical, and
not affected by nearby wires and/or metallic objects that share a
common electrical ground with the RF energy source.
[0010] In one embodiment, the coil can be incorporated into an
elastically deformable patient conforming garment. The coils are
secured to the garment. The conductive portion of the coils has a
woven construction such that the coils can be deformed as the
garment elastically deforms. A woven RF shield can be incorporated
into the garment.
[0011] An elastic wire assembly can be used to form the coils.
Elastic wire assembly can include a non-conductive elastic core, a
woven conductor secured to the core and a non-conductive elastic
sheath over the woven conductor. The elastic core can include a
plurality of polymer strands which can be deformed elastically. The
non-conductive elastic sheath can include a woven fabric. The
device as described herein can incorporate or be used in
conjunction with a muscle stimulator for treatment of various
conditions and wound healing. When used for wound healing the
patient wearable garment with coil is connected to a patient. The
coil is activated to heat a patient's body part to create increased
blood circulation therein. Electrodes of the muscle stimulator are
placed proximate to the muscles at the wounded body part. The
muscles are then stimulated to increase blood circulation therein.
Muscle stimulation is preferably performed while the RF coil is
turned off.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a functional block diagram of a device in
accordance with the present invention;
[0013] FIG. 2 is a drawing of the control panel for the device in
accordance with the present invention;
[0014] FIG. 3 is a drawing of an RF coil assembly in accordance
with the present invention;
[0015] FIG. 4 is a light emitting diode (LED) circuit for tuning
the RF coil assembly;
[0016] FIG. 5 is a drawing of an elastic wire in accordance with
the present invention;
[0017] FIG. 6A is a schematic drawing of an alternative RF coil
assembly in accordance with the present invention;
[0018] FIG. 6B is a partial, cross-sectional portion of the
schematically represented RF coil assembly of FIG. 3A; and
[0019] FIG. 7 is a cross-sectional, schematic drawing of an
alternate RF coil assembly for foot/ankle applications.
DETAILED DESCRIPTION OF THE INVENTION
[0020] Referring now to the drawings, wherein like numerals
represent like elements throughout the several views, FIG. 1 is a
block diagram of a device 100 in accordance with the present
invention. Device 100 includes an RF heater portion 110 and a
muscle stimulator portion 120. The RF heater portion 110 includes
an RF signal generator 125 powered by a power supply 127 and a
helical coil applicator 130 for insertion of a body part such as a
lower leg within and for application of RF diathermal treatment to
the body part. RF heater portion 110 also includes a manual on-off
switch 140 and a manual power level selector control 150. Device
100 also includes a muscle stimulator portion 120 includes a muscle
stimulator signal generator 155 powered by a power supply 157, at
least two electrode pads 160 for application of the muscle
stimulation power, and manual on-off switch 170 and a manual power
level selector control 180. The RF signal generator 125 and muscle
stimulator signal generator 155 can be powered by the same or
different power supplies 127.
[0021] The RF heater part 110 of the device 100 is a shortwave
diathermal unit for generation of deep heat within body tissues. It
applies electromagnetic energy in the radio frequency bands of
13.56-40.68 Megahertz. The RF power generator circuit 125 includes
an oscillator-driver 183 and a power amplifier 187. Several devices
have been proposed for RF warming by Olsen. These are disclosed in
U.S. Pat. No. 4,685,462 entitled "Method and Apparatus for
Treatment of Hypothermia by Electromagnetic Energy", dated Aug. 11,
1987 and U.S. Pat. No. 5,160,828, entitled "Electromagnetic Warming
of Submerged Extremities", dated Nov. 3, 1992 and both incorporated
herein by reference.
[0022] The muscle stimulator part 120 includes two output channels,
preferably having a peak current of 145 milliAmperes (mA), maximum
phase change of 51.8 microCoulombs and peak power of 10 milliwatts
(mW), at 500 Ohms resistance. The waveform is preferably biphasic
and symmetrical. The frequency of the wave is preferably 55 Hz and
the on-off timing is about 1.3 sec on and about 1.5 sec off. The
muscle stimulator 120 is operated by direct application of voltage
to the skin by means of electrode pads 160. The stimulator has an
automatic shutoff timer 190 which shuts it down after about 45
minutes. A buzzer will sound if the patient/operator has failed to
turn off the switch 170 by this time. Usually, the warming unit 110
and the muscle stimulator 120 will not operate at the same time due
to electromagnetic interference between the two portions 110 and
120.
[0023] The following table lists exemplary characteristics of the
device 100.
1 Control Unit 190 Size (W .times. D .times. H): 7.5" .times. 4.5"
.times. 2.75" Weight: 11 lbs. RF Heater Part 110 Frequency: 27.12
MHz Wavelength: 11.06 meters Mode: continuous Output Power: 8-24
Watts Applicator 130: helical coil Turning to Resonance: manual
Power Control: manual Power Consumption: 28 Watts operating; 50 VA
charging Energy Course 127: Rechargeable battery, 12-24 Volts DC,
in 6 V gradations Specific Absorption minimum 1 W/kg; maximum Rate
("SAR"): 4 W/kg Cooling: heat sink Fuse 195: Yes Muscle Stimulator
Part 120 Waveform: Bi-phasic Description: Symmetrical, Balanced,
Spiked Current: 0-250 mA Power Source 127: Rechargeable batteries;
12 & 6 Volts DC Maximum Phase Charge: 51.8 microCoulombs
(.mu.C) 25.9 .mu.C per phase at 500 Ohms .OMEGA. Peak Amplitude: 90
V baseline to peak Duty Cycle: 1.3 sec. on; 1.5 sec. off Frequency:
55 Hz.
[0024] All of the above described values are exemplary and may be
varied without departing from the spirit or scope of the invention.
For example, the RF power may be 8 watts for light individuals or
24 watts for heavier patients.
[0025] FIG. 2 is a view of a control panel 190 for device 100.
Control panel 190 includes an assortment of switches, indicators,
knobs, and other surface hardware labeled as to function. The
device 100 limits the power by controlling voltage. Voltage can be
selected by select switch 250. The three power levels of the RF
heating unit 110 (12V, 18V, 24V) are clearly indicated by labels
240. Power off is indicated by label 255. A current drain meter 260
indicates the amplitude of the electrical current flowing to the RF
unit. All energy output ports are clearly marked on the control
panel 190. RF power is output to line 261.
[0026] The muscle stimulation portion 120 has labeling on the
control panel 190 indicating two output channels 263 and 265 with
intensity setting 1-10 in increments of 1, set by controls 270 and
280, respectively, and turned on or off by on-off switches 282 and
285, respectively. Exemplary equivalent power density at each
intensity setting is described in the following table:
2 Power Density Intensity Setting Microwatts/Sq. Cm. 1 86 2 172 3
258 4 344 5 430 6 516 7 602 8 688 9 744 10 860
[0027] A labeled light emitting diode 290 is used to indicate that
the power is on (red) and green LEDs 300 and 310 indicates when the
pulse train is on for channels one or two, respectively. A power
off/on switch 256 for stimulator part 120 is disposed at the lower
left. The following is a listing of remaining switches, gauges,
input/output ports, etc. of control panel 190: fuse(s) 195, muscle
stimulator Channel 1 output jack 263, muscle stimulator Channel 2
output jack 265. The duty cycle indicator is a blinking yellow
light 292 located above muscle stimulator power switch 256; it
indicates when electrical current is flowing through the
stimulator. The muscle stimulator part 120 utilized high voltage
medical-grade cables with 1/4" phone plugs for the outlet channels
and with carbon rubber electrodes, both the cables and electrodes
being obtained from Bloomex Medical Corp, 295 Molnar Drive,
Elmswood Park, N.J. 07407-3211. The device is suitable for
application to various anatomical sites, including, but not limited
to, lower legs, feet, joints, hands and knees.
[0028] FIG. 3 is a schematic view of an RF diathermy coil assembly
130 in accordance with the present invention. Coil assembly 130
includes a patient wearable garment 310, such as a glove. A
patient's hand can be placed within glove 310. Preferably, glove
310 is formed from a flexible, elastically-deformable material such
that the glove can be sized to snuggly, yet not restrictively fit
to a patient's hand. Primary coil 318 and secondary coil 320 are
affixed to glove 310 by fasteners 321. Thread, staples, glue or
other fasteners which would allow glove 310 to elastically deform
can be used to fasten coils 318 and 320 to glove 310.
[0029] Primary coil 318 can be connected to R signal generator 125
by lead 322. Coil assembly 130 can include a tuning device for
adjusting the RF frequency passing through coils 318 and 320. The
tuning device preferably includes a tuning capacitor 328 connected
to secondary coil 320 and an LED 329 disposed adjacent a coil.
Tuning capacitor can be adjusted until LED 329 appears its relative
brightest. At that point, the RF frequency will be roughly the
resonant frequency of the patient's hand within glove 310. This
frequency is preferably the resonant frequency of the nearest ISM
frequency. Primary and secondary coils 318 and 320 can be formed
from an elastic wire 400 described in more detail below with
respect to FIG. 5. Elastic wire 400 allows the wrist portion of
glove 310 to stretch over the palm of the patient as glove 310 is
placed on the patient's hand. Elastic wire 400 will then
elastically rebound to be snug around the patient's wrist. Glove
310 and coils 318 and 320 can be sized such that in view of the
elastic character of glove 310 and wires 400, a snug positive fit
between the patient's hand and glove 310 can be achieved.
[0030] FIG. 4 is a typical LED assembly 329 which includes an LED
331 having four bridge rectifiers 333. In reality, assembly 329 can
be directly connected to a coil, but as discussed previously, need
merely be placed against a coil in the RF field to be functional.
The RF field will be closest to resonant frequency when the LED is
at its brightest under the influence of the field.
[0031] FIG. 5 is a drawing of an elastic wire 400 in accordance
with the present invention. As shown, elastic wire 400 includes a
plurality of elastic polymer filaments 402 surrounded by a woven
insulative sheath 404. A woven conductive member 406 surround
sheath 404 and an insulative cover 408 surrounds conductor 406.
Each of the woven members 404, 406 and 408 can have a weave pattern
similar to that shown for conductive member 406. As such, these
members can be elongated when placed under longitudinal stress.
Sufficient mechanical connection should be made between the woven
layers and the elastic filament 402 that if elastic wire 400 is
placed under stress, it will elongate, and when the stress is
relieved, it will shorten as the elastic filaments 402 shorten.
Elastic filaments may be woven into member 404 and 406 to increase
the elastic rebound of elastic wire 400 when stress is removed from
the wire. In one embodiment, wire 400 can stretch elastically
approximately 30% of its relaxed length. If the wire is used to
form a coil, the diameter of the coil can decrease approximately
10% when the wire elongates approximately 30%, the electrical
conductivity of the coil remains constant.
[0032] FIG. 6A is a schematic view of an alternate embodiment of
the RF diathermy coil assembly 530 in accordance with the present
invention. Assembly 530 includes a patient wearable garment 510.
Garment 510 as shown in FIG. 6A is substantially tubular shaped and
hollow including passage 512 therethrough. A patient limb of body
part can be placed within passage 512. Preferably garment 510 is
formed from a flexible elastically deformable material such as a
polymer foam. The transverse cross section of passage 512 in
garment's 510 relaxed state is preferably slightly larger than the
transverse cross section of a patient body part placed therein such
that garment 510 will have a slightly snug fit on the patient body
part.
[0033] Garment 510 as shown in FIG. 6A is formed from two layers of
fabric 514 and 516. Sandwiched between layers 514 and 516 is a
primary coil 518 and a secondary coil 520 (primary coil 518 is
shown shaded to contrast it from secondary coil 520). Primary coil
518 is connected to RF signal generator 525 by lead 522.
[0034] Coil assembly 530 preferably includes a tuning device which
enables the RF frequency passing through coils 518 and 520 to be
tuned to the resonant frequency of the body part disposed within
passage 512 of garment 510. The tuning device can include a balun
526 connected to primary coil 518 and a tuning capacitor 528
connected to secondary coil 520. An LED 529 can be connected to
secondary coil 520. When in use, tuning capacitor 528 can be
adjusted until LED 529 appears it's relative brightest. The balun
can be used where space is available and power is relatively
high.
[0035] Balun 526 and tuning capacitor 528 can be placed within a
housing 530 shown in FIG. 6A. Housing 530 can be releasably
connected to coils 518 and 520 by fasteners 532. Fasteners 532 are
a snap-type fastener. Any of several conductive releasable
fasteners, however, could be used. Releasably coupling housing 530
to coils 518 and 520 is a particularly advantageous feature as will
be explained in more detail below as garments such as garment 510
can be configured in numerous manners to accommodate various
patient body parts and disposable coil assemblies.
[0036] FIG. 6B is a partial, cross-sectional portion of the
schematically represented RF coil assembly of FIG. 6A. FIG. 6B
shows coils 518 and 520 sandwiched between layers 514 and 516.
Disposed to the outside of layer 516 is an RF shield 534. RF shield
534 may be, for example, a steel screen such as the fabric used to
make window screens. Shield 534 can be protected from abrasion or
snagging by covering 536 shown pulled partially away from layer 516
to reveal shield 534.
[0037] FIG. 7 is a cross-sectional, schematic view of a coil
assembly 630 for a calf, foot and ankle A. Similarly to the coil
assembly of FIG. 6A, the coil assembly of FIG. 7 includes a
wearable garment 610 defining an opening for the calf, foot and
ankle A of a patient A primary coil 618 and a secondary coil 620
are sandwiched between layers 614 and 616. An RF shield 634 is
disposed outwardly from layer 616. Shield 634 can be protected from
abrasion or snagging by cover 636.
[0038] Housing 530, including balun 526, tuning capacitor 528 and
lead 532 can be releasably coupled to the coil assembly of FIG. 7
by fasteners 532 as described above. It can be appreciated that the
coil assembly garment can be configured as in FIG. 6A or as
configured FIG. 7, as well as in several other configurations such
as a glove to fit various body parts. The housing and related
components, however, need not vary in configuration but can be
releasably fastened to any of the garments.
[0039] In use, for wound healing, a tissue of the patient which
tissue is to be treated is identified. The tissue can include skin,
a muscle and a nerve vascular bed. The tissue is heated by RF
diathermy for a period of time, for example, about 10-30 minutes,
preferably to a maximum of 40.degree. C. That heating induces
vasodilation oxygen perfusion to at least a portion of the tissue.
After the RF diathermy heating, muscle stimulation increases oxygen
delivery and increase the flow of previously warmed blood to the
tissue. Muscle stimulation continues for an exemplary period of
usually less than 45 minutes and preferably for a period of from
10-30 minutes.
[0040] Because of the consequential increased oxygen and blood
perfusion, the RF heating better prepares the muscle for muscular
contraction, and makes it less likely that the muscle contractions
will cause soreness, cramping or irritation. Thus, the RF heating
before the muscular stimulation enhances the safety of this
treatment, which is an especially important feature because the
subjects of this treatment are often elderly or have severe
muscular atrophy. It should be noted that for wound healing, a
beneficial effect is expected from RF heating or muscle stimulation
together as described above or independently.
[0041] The device 100 is designed for home use directly by the
patient without the immediate supervision of a health-case
practitioner. As to the RF diathermy, the device uses a
rechargeable battery 127, thus minimizing the risk of
electrocution. Individuals not undergoing treatment should stay
outside of a 1 meter range while the RF heating unit is on. Fuses
are used in the device 100 to protect against short circuits and
component failure. The energy used by the RF signal generator 125
is controlled through the power source 127 by limiting voltage
which can be varied from 12V to 24V by a power switch 140. The
helical coil applicator 130 will deliver energy in longitudinal
electrical fields with respect to the limb. The helical coil 130 is
approximately five turns with about 7 foot of coil length.
[0042] The level of deep heating for the patient using the device
100 will not exceed 3.degree. C. above normothermic temperature.
The level of deep heating for the patient using the device 100 is
controlled by the setting of the power level selected control 150.
The RF heater part 110 is tuned to resonance by a tuning capacitor
which the patient will tune to the brightest level of a light
emitting diode LED located near the tuning capacitor. The resonance
tuning is preferably first performed at a low level of power,
before the actual therapeutic level is set. The capacitor
adjustment is to be monitored during the treatment so that it
remains at the brightest level. Keeping the RF diathermy unit 110
in resonance (by adjusting the capacitor rather than adjusting the
operating frequency) keeps the warming at optimal efficiency in
terms of energy in/energy out in the firm of body warming
capability.
[0043] The device 100 delivers energy instantly, with a subsequent
thermal rise occurring primarily throughout the muscle. In general,
fat and bone are heated at a much lower rate than muscle. The RF
unit 110 uses a fixed radiofrequency circuit 125 with 11.06 meter
waves and 27.12 MHz frequency. A high efficiency RF source is used
with minimal loss of power and maximal energy delivered. Due to the
nature of this heating method and the limitation of power from the
energy source 127, there is little likelihood of overheating and/or
skin bums. The tuning of the RF circuit (including the coil 130)
into resonance is influenced by the composition of fat, muscle, and
bone of the patient's limb, and generally varies from patient to
patient.
[0044] As to muscle stimulation, the unit is fused for prevention
of surging. The device is heat-sinked so that it does not overheat;
it has two output circuits (or channels) that are variable in
amplitude. The muscle stimulator unit's power cannot be activated
until both channels are set on "0" when the device is turned on.
Furthermore, as shown in FIG. 1, the muscle stimulator will not
work while the battery 127 is being charged.
[0045] Heating by the RF diathermy step of this regime occurs
throughout all tissues of the limb; therefore, certain
perfusion-reducing affects are prevented such as that of excessive
arteriovenous (AV) shunting of blood that might occur in diabetic
neuropathy patients who are treated with surface-only warming. With
total-tissue warming, the core vasculature is dilated thus
increasing oxygen perfusion to the endoneurium (nerve capillary
bed) and improving neural function.
[0046] The RF heating portion of the diabetic neuropathy regime is
preferably done over a period of generally less than about
forty-five minutes. Alternately, the leg of the subject could be
inserted in a leg coil of a heating element at night and worn
during sleep, when flow rates are lowest, provided that body
movement during sleep should somehow be restricted so as to prevent
the patient from being entangled in the RF cable. The RF heating
apparatus would be automatically turned on and off intermittently
during the night and, ostensibly, prevent stasis and hypoxia during
this low blood flow rate danger period.
[0047] For lower extremity treatment, the lower leg is placed
inside helical coil 130. It is recommended that the patient be
seated or lying down and not be standing during the RF diathermy
and muscle stimulation treatment application. All metallic jewelry
should be removed from the part of the tissue being treated. The
on-off switch 140 is turned on and the level control 150 is set to
one of the three available power levels closest to the prescribed
power level. The leg is warmed by the RF diathermy part 110 for 25
minutes. The on-off switch 140 is turned off. The electrode pads
160 of the muscle stimulator component 120 are placed on the
following muscles of the leg being treated: tibialis anterior,
vastus lateralis, soleus, and rectus femoris. For use of carbon
rubber electrodes 160, the electrodes 160 are fastened on the
patient with Velcro pads so as to hold the electrodes 160 firmly
against the patient's skin. The electrode pads 160 are thoroughly
wetted with salt water (the precise concentration of sodium is not
important), and the electrodes 160 are checked for the absence of
oil. If the salt water beads up on the black electrode surface,
then there is oil on it. The electrodes 160 should then be
thoroughly scrubbed with a mild abrasive cleaner and a scrub brush,
until water no longer beads on the surface. New electrodes 160 may
have to be washed several times to remove the oil. If the electrode
pads dry out during the course of a treatment, they should be
rewetted.
[0048] The on-off switch 170 is turned on and the level control 180
is adjusted to a level sufficient to make the muscles visibly
contract. The muscles are contracted for 25 minutes. The
electrodes. 160 may be shifted and repositioned during the course
of a treatment. If they are partially pulled away from the surface
of the skin while current is flowing, the patient may feel a sharp
tingling sensation. Therefore, the output channel should be turned
off to reposition or rewet the electrodes 160. After muscle
stimulation treatment is concluded, the on-off switch 170 is turned
off and the electrode pads 160 are removed from the leg.
[0049] Another type of electrode 160 that might be used is
self-adhesing gel pads 160. Always clean the skin with alcohol
before applying these electrodes 160. Place the electrodes 160
firmly on the dry skin.
[0050] The protocol for treatment of a hand having Carpal Tunnel
Syndrome includes placing the glove applicator on the hand to be
treated. The on-off switch 140 is turned on and the level control
150 is set to the power level prescribed by a physician. The hand
or hands is or are warmed by the RF diathermy part 110 for 25
minutes. The on-off switch 140 is turned off. The electrode pads
160 of the muscle stimulator component 120 are placed on the
following muscles of the hand or hands and forearm or forearms
being treated: flexor carpi unlaris, palmaris, pronator quadratus,
lumbricals, palmarand dorsal interossei, pollicis brevis, palmaris
brevis, and digiti minimi brevis. The on-off switch 170 is turned
on and the level control 180 is adjusted to a level sufficient to
make the muscles visibly contract. The muscles are contracted for
25 minutes. The on-off switch 170 is turned off. The heating muscle
stimulation process can be repeated as necessary.
[0051] In addition to heating for wound healing, diabetic
neuropathy and Carpal Tunnel Syndrome, heating may also be
preformed for treatment of Raynaud's disease. In such a case, a
form of a coil assembly such as that shown in FIG. 3 would be used
to warm the Raynaud's patients' fingers which often feel cold.
[0052] Numerous characteristics and advantages of the invention
covered by this document have been set forth in the foregoing
description. It will be understood, however, that this disclosure
is, in many respects, only illustrative. Changes may be made in
details, particularly in matters of shape, size, and arrangement of
parts without exceeding the scope of the invention. The invention's
scope is, of course, defined in the language in which the appended
claims are expressed.
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