Abstract:
An RF diathermy coil assembly includes a patient-conforming garment defining a passage for receiving a body part therein and a primary coil including a number of windings disposed around the passage. The primary coil is connectable to a power source lead and is incorporated into the patient-conforming garment. The primary coil is responsive to RF power delivered via the power source lead for establishing an RF field. A secondary coil is provided that includes a number of windings disposed around the passage. The secondary coil is disposed proximate the primary coil and is incorporated into the patient-conforming garment. A tuner is coupled to the secondary coil for tuning the RF field to a resonant frequency of the body part disposed within the passage.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of co-pending application Ser. No. 12/028,241, filed on Feb. 8, 2008, entitled “RF Diathermy and Faradic Muscle Stimulation Treatment”, which is a continuation of abandoned application Ser. No. 10/775,959, filed on Feb. 10, 2004, which is a division of application Ser. No. 09/616,769, filed on Jul. 14, 2000 (now U.S. Pat. No. 6,735,481), which is a division of application Ser. No. 09/046,856, filed on Mar. 24, 1998 (now U.S. Pat. No. 6,094,599), all of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    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. 
         [0003]    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 2  flow to wound tissue is increased. Increased blood flow and thus O 2  flow to the wound tissue is believed to be of substantial aid in wound healing. 
         [0004]    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. 
         [0005]    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. 
         [0006]    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. 4,368,410 to Hance et al. (ultrasound); U.S. Pat. No. 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. 
         [0007]    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 
       [0008]    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. 
         [0009]    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. 
         [0010]    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. 
         [0011]    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. 
         [0012]    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&#39;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 
         [0013]      FIG. 1  is a functional block diagram of a device in accordance with the present invention; 
           [0014]      FIG. 2  is a drawing of the control panel for the device in accordance with the present invention; 
           [0015]      FIG. 3  is a drawing of an RF coil assembly in accordance with the present invention; 
           [0016]      FIG. 4  is a light emitting diode (LED) circuit for tuning the RF coil assembly; 
           [0017]      FIG. 5  is a drawing of an elastic wire in accordance with the present invention; 
           [0018]      FIG. 6A  is a schematic drawing of an alternative RF coil assembly in accordance with the present invention; 
           [0019]      FIG. 6B  is a partial, cross-sectional portion of the schematically represented RF coil assembly of  FIG. 3A ; and 
           [0020]      FIG. 7  is a cross-sectional, schematic drawing of an alternate RF coil assembly for foot/ankle applications. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]    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 . 
         [0022]    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. 
         [0023]    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 . 
         [0024]    The following table lists exemplary characteristics of the device  100 . 
         [0000]                                    Control Unit 190           Size (W × D × H):   7.5″ × 4.5″ × 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 Source 127:   Rechargeable battery, 12-24 Volts DC,           in 6 V gradations       Specific Absorption Rate   minimum 1 W/kg; maximum 4 W/kg       (“SAR”):       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 &amp; 6 Volts DC       Maximum Phase Charge:   51.8 microCoulombs (μC); 25.9 μC           per phase at 500 Ohms Ω       Peak Amplitude:   90 V baseline to peak       Duty Cycle:   1.3 sec. on; 1.5 sec. off       Frequency:   55 Hz.                    
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: 
         [0000]                                                          Intensity Setting   Power Density Microwatts/Sq. Cm.                                        1   86           2   172           3   258           4   344           5   430           6   516           7   602           8   688           9   744           10   860                        
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 ¼″ 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.
 
         [0027]      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&#39;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&#39;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 . 
         [0028]    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&#39;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&#39;s hand. Elastic wire  400  will then elastically rebound to be snug around the patient&#39;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&#39;s hand and glove  310  can be achieved. 
         [0029]      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. 
         [0030]      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. 
         [0031]      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&#39;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. 
         [0032]    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 . 
         [0033]    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&#39;s relative brightest. The balun can be used where space is available and power is relatively high. 
         [0034]    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. 
         [0035]      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 . 
         [0036]      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 . 
         [0037]    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. 
         [0038]    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° 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. 
         [0039]    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. 
         [0040]    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. 
         [0041]    The level of deep heating for the patient using the device  100  will not exceed 3° 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 film of body warming capability. 
         [0042]    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 burns. 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&#39;s limb, and generally varies from patient to patient. 
         [0043]    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&#39;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. 
         [0044]    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. 
         [0045]    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. 
         [0046]    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&#39;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. 
         [0047]    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. 
         [0048]    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. 
         [0049]    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. 
         [0050]    In addition to heating for wound healing, diabetic neuropathy and Carpal Tunnel Syndrome, heating may also be preformed for treatment of Raynaud&#39;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&#39;s patients&#39; fingers which often feel cold. 
         [0051]    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&#39;s scope is, of course, defined in the language in which the appended claims are expressed.