WO2004098700A2 - Procede et appareil de stimulation electromagnetique de nerf, de muscle et de tissus anatomiques - Google Patents

Procede et appareil de stimulation electromagnetique de nerf, de muscle et de tissus anatomiques Download PDF

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Publication number
WO2004098700A2
WO2004098700A2 PCT/US2004/013978 US2004013978W WO2004098700A2 WO 2004098700 A2 WO2004098700 A2 WO 2004098700A2 US 2004013978 W US2004013978 W US 2004013978W WO 2004098700 A2 WO2004098700 A2 WO 2004098700A2
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WO
WIPO (PCT)
Prior art keywords
appliance
conductive material
coil
pulse
generation unit
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Application number
PCT/US2004/013978
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English (en)
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WO2004098700A3 (fr
Inventor
Daniel Burnett
Shane Mangrum
Francesco Lisi
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Thera Nova Llc
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Publication date
Application filed by Thera Nova Llc filed Critical Thera Nova Llc
Publication of WO2004098700A2 publication Critical patent/WO2004098700A2/fr
Publication of WO2004098700A3 publication Critical patent/WO2004098700A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets

Definitions

  • the present invention relates to the field of medical devices, in particular electromagnetic stimulating devices for stimulation of nerve, muscle, and/or other body tissues with applications in the field of medicine.
  • PEMFs can not only facilitate fracture healing but also promote numerous other positive effects on the human body, including: (1 ) causing muscles to contract, (2) altering nerve signal transmission to decrease experienced pain, and (3) causing new cell growth in cartilage.
  • Solenoid type coils create pulsed electromagnetic fields inside the coil that are relatively uniform throughout, with peak field strength at the center of the coil.
  • Examples of existing devices with tightly wound coil arrangements include:
  • This device requires a trained technician to treat the patient and to properly hand hold the open end of the "C" over the targeted nerve or muscle to be stimulated.
  • the device is not portable and is designed for use in hospitals or similar institutions.
  • the vanadium permendur core is required to increase the strength of the electromagnetic field to be strong enough to be effectively used.
  • the design, shape and configuration described in Davey and other prior art devices, require the electromagnetic stimulator to be hand operated during use.
  • Tepper in U.S. Patent 5,314,401 , 5/24/1994 describes a pulsed electromagnetic field transducer that is intended to be conformable to the contour of a patient' s body.
  • the PEMF transducer in this application as having a desired form and sufficient rigidity to maintain an anatomical contour.
  • This system is disadvantageous in a number of respects.
  • the desired contouring of this device will require that a significant number of different sizes be manufactured to accommodate the contours of an endless variety of body shapes.
  • the intended device does not incorporate markings to ensure that the device is placed in a correct alignment over the targeted area of the body.
  • this proposed device utilizes flat, wound coils, providing PEMFs that do not penetrate as deeply or as uniformly into body tissues as those fields produced by solenoid coils.
  • Mould describes dual coil assemblies in a magnetic stimulator for neuro-muscular tissue, with cooling provided for the transducer coil.
  • This device is intended to be held by a trained user over the targeted regions of the body in order to deliver PEMF therapy.
  • the design of this device is limited by the difficult nature of manipulating a single coil and the cost- intensive requirement of using highly skilled medical personnel for operation.
  • March' s U.S . Patent 6,200,259 B l , 3/13/2001 describes a device with electromagnetic field coils applied front and back to a patient for treating cardiovascular disease by angiogenesis.
  • An EMF dosage plan contemplates, multiple coil implants and pulse variables including carrier frequency, pulse shape, duty cycle, and total time exposed.
  • This device describes the placement of coils around the regions of tissues in which collateralization of blood flow (or angiogenesis) is desired.
  • the design contemplates applications including the use of coils embedded in a cloth wrap, which could be worn as a garment surrounding the body area of interest. Alternatively, a wrap with embedded coils to be placed around an arm or a leg to deliver the desired field is described.
  • PEMF in this application for the purpose of modulation of angiogenesis shows significant promise.
  • the description of this device does not suggest any extension of the electromagnetic phenomenon in circumstances where PEMF stimulation can provide dramatic opportunities for the treatment of osteoarthritis, and musculoskeletal pains including tendonitis, bursitis, and muscle spasms.
  • this invention does not provide for the use of solenoid -type coils for the delivery of PEMF.
  • Poison's U.S. Patent 5,766, 124, June 16, 1998 describes a magnetic stimulator of neuro-muscular tissue.
  • the primary aim of this invention is devise a reserve capacitor providing more efficiency in the control circuitry.
  • the description of the device describes the stimulating coil in broad, generic terms, and does not contemplate application of the coil in any type of body wrap or other specific method for delivering PEMF to targeted areas of the body.
  • this device is disadvantageous, in the respect that is does not provide for any method or delivery system to provide consistent, uniform PEMF stimulation.
  • Lin in U.S. Patent 5,857,957, issued Jan. 12, 1999 teaches the use of functional magnetic stimulation for the purpose of inducing a cough function in a mammalian subject.
  • the description of the device provides for the use of hand -held stimulation coil, intended to be placed over the anterior chest of the subj ect for the purpose of stimulating nerves to induce a cough.
  • This system is disadvantageous in the requirement of hand- held delivery, which is difficult and inconsistent.
  • the description contemplates use of the device in the induction of cough, and does not contemplate extension of the use of the device into other areas of neuromuscular stimulation.
  • Tepper in U.S. Patent No. 6,024,691 , issued 2/15/2000 describes a cervical collar with integral transducer for PEMF treatment.
  • the description of this device provides for the use of a single coil transducer, formed into the shape of a cervical collar.
  • This system is disadvantageous in several respects.
  • this device does not provide for the use of solenoid -type coils in the delivery of PEMF, which can provide a more uniform and consistent signal.
  • the semi- rigid design of the collar complicates the delivery of PEMF to persons of differing body sizes.
  • the design and semi-rigid nature of the device would make an exact fit difficult, thereby diminishing the effectiveness of any delivered therapy. Furthermore, this device is designed to immobilize the neck and is therefore not applicable to most patients. Whereas, with a flexible, ergonomic delivery system for PEMF stimulation, various sizes of wraps can accommodate nearly any type of body habitus. Lastly, the device must be lowered over the head making application difficult versus the invention found in Figs 4 and 6 where the coil can be opened to allow entrance of the body part.
  • the rigidity of the device necessary to serve the bracing function makes the device less comfortable to wear, especially for a person who would not require bracing (such as in the treatment of arthritis, muscle spasm, or other forms of musculoskeletal pain).
  • the device is described as a rigid bobbin through which the extremity is placed.
  • This format makes application more difficult in that the applicator cannot be worn and therefore does not provide for consistent ideal placement of the extremity to maximize field effects.
  • most designs of a similar nature are clinic -based devices and, therefore, would not be amenable to home healthcare applications as with the current invention.
  • the device described magnetic field within the bobbin is intended to have a maximum magnetic flux density in the range of 4.5 to 6 gauss.
  • Studies such as by Trock et al in the Journal of Rheumatology 1994; 21 (10): 1903- 191 1 have shown that PEMF stimulation in the range of 15- 25 or more gauss are effective in the treatment of osteoarthritis or other musculoskeletal pain conditions.
  • One embodiment of the present invention provides a system for pulsed electromagnetic stimulation of a target member, that system comprising: a pulse control and generation unit; a conformable member appliance coupled to the pulse control and generation unit; an insulated conductive material disposed within the appliance and proximate to the target member and producing a pulsed magnetic field when an electrical pulse is passed through the conductive material by the pulse control and generation unit.
  • Another embodiment of the present invention provides such a system wherein the conformable member comprises an inflatable layer.
  • a further embodiment of the present invention provides such a system wherein the inflatable layer comprises a layer of self-inflatable foam.
  • Still another embodiment of the present invention provides such a system further comprising a pump coupled to the layer of self-inflating foam such that the self-inflating foam can be deflated for insertion of the target member into the appliance.
  • a still further embodiment of the present invention provides such a system wherein the pump is selected from the group of pumps consisting of manual and automatic pumps.
  • the conductive material comprises at least one spring tensioned wire.
  • An even further embodiment of the present invention provides such a system wherein the appliance comprises an expandable sleeve.
  • the expandable sleeve comprises an expandable, conformable fabric selected from the group of fabrics consisting of man made stretch fabrics, knitted fabrics, elasticized fabrics, latex, and rubber.
  • a yet further embodiment of the present invention provides such a system wherein the insulated conductive material is arrayed in a modified Helmholtz configuration such that first and second coils have an axis normal to an axis of the appliance, the coils conform to the shape of the target member and have a maximum separation equal to the diameter of the coil.
  • One embodiment of the present invention provides such a system wherein the insulated conductive material is configured in first and second coils arrayed in a classic Helmholtz configuration.
  • Another embodiment of the present invention provides such a system wherein the insulated conductive material is substantially solenoidal in configuration, and comprises flexible wires configured for folding without damage.
  • a further embodiment of the present invention provides such a system wherein the appliance is substantially larger than the radius of the target member and is configured to fold over and fasten.
  • Still another embodiment of the present invention provides such a system wherein the appliance further comprises a conductive layer connected to ground whereby the controller is triggered to interrupt the electrical pulse in the event of a failure in insulation of the conductive material.
  • a still further embodiment of the present invention provides such a system wherein the conductive layer is disposed between the insulated conductive material and at least one exterior insulating layer.
  • Even another embodiment of the present invention provides such a system wherein the electrical pulse has a current of between 20 and 50 amps.
  • a pulse control and generation unit comprises: a current sensor, monitoring electrical current flow through the insulated conductive material; a control circuit, receiving data from the current sensor; a switch controlled by the control circuit; a diode disposed within the pulse generation and control circuit such that when the switch is open, the electric current flows through the insulated conductive material will decay.
  • a resistor disposed in series with the insulated conductive material.
  • a yet further embodiment of the present invention provides such a system wherein the control circuit comprises: an oscillator, the oscillator controlling the frequency of the electrical pulse; and a voltage comparator where by a reference voltage is compared to a signal produced by the current sensor.
  • One embodiment of the present invention provides such a system wherein the a pulse control and generation unit further comprises a first timer where by a user can program the system to provide the pulsed electromagnetic field for a desired time period.
  • Another embodiment of the present invention provides such a system wherein the pulse control and generation unit further comprises a second timer whereby the system may be programmed to provide the pulsed electromagnetic filed for no longer than a prescribed time period.
  • Figure 1 is a perspective view of a pulsed electromagnetic stimulation device configured in accordance with one embodiment of the present invention.
  • Figure 2 is a perspective view of appliance of a pulsed electromagnetic stimulation device configured in accordance with one embodiment of the present invention.
  • Figure 3 is a perspective view of an open expanded appliance of a pulsed electromagnetic stimulation device configured in accordance with one embodiment of the present invention.
  • Figure 4 is a perspective view of a closed appliance of a pulsed electromagnetic stimulation device configured in accordance with one embodiment of the present invention.
  • Figure 5 is a perspective view of an expanded appliance of a pulsed electromagnetic stimulation device illustrating an expanded spring wound coil configured in accordance with one embodiment of the present invention.
  • Figure 6 is a perspective view of a contracted appliance of a pulsed electromagnetic stimulation device illustrating a relaxed spring wound coil configured in accordance with one embodiment of the present invention.
  • Figure 7A is a perspective view of an expanded appliance of a pulsed electromagnetic stimulation device illustrating a classic Helmholtz orientation of coils configured in accordance with one embodiment of the present invention.
  • Figure 7B is an elevation view of an expanded appliance of a pulsed electromagnetic stimulation device illustrating a classic Helmholtz orientation of coils configured in accordance with one embodiment of the present invention.
  • Figure 8A is a perspective view of an expanded appliance of a pulsed electromagnetic stimulation device illustrating a modified Helmholtz orientation of coils configured in accordance with one embodiment of the present invention.
  • Figure 8B is an elevation view of an expanded appliance of a pulsed electromagnetic stimulation device illustrating a modified Helmholtz orientation of coils configured in accordance with one embodiment of the present invention.
  • Figure 9 is a perspective view of appliance of a pulsed electromagnetic stimulation device illustrating a deflated inflatable fitting lining configured in accordance with one embodiment of the present invention.
  • Figure 10 is a perspective view of appliance of a pulsed electromagnetic stimulation device illustrating an inflated inflatable fitting lining configured in accordance with one embodiment of the present invention.
  • Figure 11 is a perspective view of appliance of a pulsed electromagnetic stimulation device illustrating a deflated inflatable fitting lining having a manual inflation pump attached configured in accordance with one embodiment of the present invention.
  • Figure 12 is a perspective view of appliance of a pulsed electromagnetic stimulation device illustrating a pump manual inflation nozzle configured in accordance with one embodiment of the present invention.
  • Figure 13 is a photograph of an oscilloscope illustrating the waveform of the signal produced by one embodiment of the present invention.
  • Figure 14 is a schematic diagram of a pulse generation and control circuit configure according to one embodiment of the present invention.
  • Figure 15 is a schematic diagram of a DC power supply configured according to one embodiment of the present inventions.
  • Figure 16 is schematic diagram of a current control circuit configured according to one embodiment of the present invention.
  • one embodiment of the present invention provides a Pulsed Electromagnetic Stimulation (PES) appliance 10 coupled to an external logic controller consol 22 providing an electric signal via a connection cable 16.
  • the connection cable 16 mates with a port 20 disposed within the external logic controller consol 22 via a coupler 18.
  • the external logic controller consol also provides a variety of controls 24 whereby the electronic signal may be adjusted by a user as described by a therapist.
  • the PES appliance 10 of Fig. 1 is illustrated in greater detail in Fig.2.
  • the PES appliance 10 comprises at least one coil of wire 1 1 wrapped in a plurality of twists.
  • This coil of wire 11 may be, as one of ordinary skill in the art will readily appreciate, configured in a variety of configurations within the scope of the present invention. According to one embodiment of the present invention, this coil of wire 1 1 may be disposed between layers of flexible, conformable, insulating material 12.
  • the coil of wire 11 has, for the sake of clarity been illustrated in solid lines.
  • a grounded conductive layer 14 is disposed within the appliance between the coils 1 1 and the target member, whereby the controller consol 22 is deactivated in the event of failure of the insulation of the coil 1 1, as sensed by a voltage sensor 80, illustrated in Figure 14.
  • the wires 1 1 within the PES Appliance comprise a flexible conductive material.
  • the wires 11 are configured in a substantially solenoidal geometry.
  • the appliance is configured with an adequate circumference to permit a target treatment area to be introduced through the appliance 10. The appliance may then be folded over or gathered. The portion of the appliance 10 that is made redundant by this fold 32 is then secured to provide a snug fit.
  • Such means may include but are not limited to snaps, hook and eye fasteners, VELCRO ® brand fasteners and their equivalents, clips, draw strings, and straps.
  • the wires 1 1 are spring-tensioned wire 34.
  • the spring tensioned wires 34 are arrayed in a substantially solenoidal configuration.
  • an expandable fabric such as LYCRA ® , spandex, knit material, elasticized material, rubber, or latex
  • a patient or therapist may slide the appliance over the target area.
  • the appliance 10 will expand to allow proper placement of the appliance yet once placed, will conform to the target area.
  • FIGs 7A and 7B illustrate two views of an embodiment of the present invention utilizing a Helmholtz Coil configuration.
  • This apparatus comprises two parallel coils 38 separated by spacers 42. At least one spacer is configured to open at a joint. This joint is closeable by a latch 44 or other fastener. The patient' s knee is disposed between the parallel coils. In this embodiment, both coils are parallel and directly opposite each other separated by a distance equal to the coil radius.
  • the coil may be placed in an ergonomic wrap (not shown) and would utilize moderately flexible spacers 42 to make sure that the proper distances are maintained. The coils will be held at the correct distance by a latching mechanism 44, accessible through the wrap and holding one of the spacers together.
  • one embodiment of the present invention illustrated in Figure 8A and 8B provides two conducting coils 38 configured with an ergonomic curve. This curve will allow the coil to be easily placed and latched 21 around the knee 15 while delivering a magnetic field of similar consistency to the more awkward Helmholtz coil of Figures 7A and 7B. Once again, these coils will be placed in an ergonomic wrap (not shown) as with all the previous applicators.
  • FIGs 9- 12 Another embodiment of the present invention, illustrated in Figs 9- 12 provides a PES appliance 10 having a self-inflating foam layer 50 disposed on the interior of the appliance 10. At least one layer of insulation 54 is provided to protect a user from shock or other injury. At least one air valve 53 is coupled to said self inflating foam layer 50, whereby air is supplied to, or withdrawn from the self inflating foam layer 50, thereby allowing the layer 53 to inflate or deflating the layer 53.
  • Fig. 9 illustrates the placement of a PES appliance 10 around a limb of a patient 36.
  • the self-inflating foam layer 50 is deflated.
  • the opening in the center of the appliance 10 dilates allowing for the free admission of the patient's limb through the center of the solenoid.
  • the self-inflating foam layer 50 is allowed to inflate, securely holding the appliance 10 to the target limb 36.
  • a pump 56 for the deflation of the self-inflating foam layer 50 may be either manual or automatic.
  • the pump may also be used to inflate the inflatable layer 50.
  • the target limb may be readily removed from the appliance.
  • a pulsed electrical signal is generated by the controller unit 22 and transmitted through the appliance 10.
  • the electrical pulse then generates a magnetic signal or pulse in the appliance.
  • This signal may be generated in a variety of different waveforms. In some instances this waveform is asymmetrical, in contrast to symmetrical waveforms such as sinusoidal or square waveforms.
  • the signal may be in a "peak and decay waveform" wherein the pulse is strongest at the beginning of a period and decays asymptotically toward zero prior to the beginning of the next period.
  • the rise time of such an embodiment may be from between 0.1 ms (milliseconds) to 10 ms.
  • the amplitude of the magnetic signal generated is between 5 and 200 Gauss.
  • the waveform may have a single or narrow band frequency of between 5 and 60 Hz.
  • a 30 Amp electrical pulse producing a 100 Gauss magnetic signal is provided. This pulse is produced in a 15 Hz peak and decay waveform, with a 0.5 ms rise time.
  • Alternative embodiments wherein the electrical pulse is between 20 - 50 Amps would likewise be within the scope of the invention.
  • FIG 14. A schematic of one embodiment of the present invention is illustrated in Figure 14. This embodiment is composed of two parts: the coil 11 and the pulse generator 22.
  • the coil 11 has the purpose of producing in the body part to which it is applied a magnetic field of suitable characteristic for the therapy to be effective, when the coil is driven by a current of suitable characteristics.
  • the pulse generator 22 has the purpose of driving the coil 11 with the current.
  • the coil 11 of one embodiment of the present invention is a foldable coil, made of 80 turns of super flexible wire, of about 80 cm length for each turn, enclosed in a wrap of fabric.
  • the wire has to be super flexible so that the whole coil can be wrapped around the body part where the magnetic field is needed.
  • the number of turns is determined by a reasonable compromise between the competing needs of producing a very large current to drive the coil 1 1 , if the turns are too few, or producing a very large voltage to drive the coil 1 1 , if the turns are too many.
  • the magnetic field With 80 turns the magnetic field, with the coil tightly wrapped around a leg of normal size, is between 3.5 and 4 gauss for each A of current in the coil. This leads to a current of 50 A peak for a peak field of between 175 and 200 gauss. 50 A is quite a large current, but in short pulses, it is still quite manageable with normal electronic components. In other embodiments a less powerful current of 30 A or less may be used to induce a field of 110 Gauss in a similarly wrapped coil.
  • the magnetic field rises from zero to the peak value in a time less than or equal to 0.5 ms, the current must rise in the same time, because the field waveform follows exactly the waveform of the current.
  • the coil 11 has an inductance and an electrical resistance, both depending on its physical dimensions. For the coil 1 1 with rise time as described above the required voltage is about 150 V. The magnetic field thus produced by the coil 1 1 in such a configuration is parallel to the bone.
  • a wrap having a reduced weight may be obtained by decreasing the number of coils.
  • An increase in current strength can compensate for the reduction in field strength resulting from the decreased coil count.
  • a 50% reduction in the number of coils is balanced with a doubling of the strength of the current.
  • the peak intensity is unchanged, while the rise and decay times are halved.
  • the pulse generator of one embodiment as illustrated in Figure 14 comprises: a DC power supply 62, of adequate output voltage, and capable of giving current pulses of the peak value, duration etc. as required by the powered circuit;
  • the DC power supply 62 does not need to be stabilized; a controlled switch 66; means for measuring the instant current flowing in the switch, current transducer, or current sensor 68, a diode 64, a means for controlling the switch 66, turning it on at a predefined frequency, and turning it off as the current reaches a predefined value 70.
  • the power supply 62 is a DC power supply powered by the domestic 110 V AC power grid.
  • the capacitor 76 flattens the pulsed voltage emitted by the rectifier 74 and acts as a reservoir, such that when the switch is closed, the current comes primarily from the capacitor 76 rather than from the transformer 72. Such a configuration, among other benefits enables a more compact and lighter transformer 72 to be used.
  • the power supply 62, switch 66, and current sensor 68 are connected to each other in series and series connected to the coil 11 , such that when the switch 66 closes, the whole DC voltage produced by the power supply 62 is applied to the coil 1 1.
  • the resistance of the switch when on, and the resistance of the current monitor, are low enough to be ignored.
  • the diode 64 is connected to the coil 11 in parallel, with polarity such as not to conduct when the switch 66 closes and thereby applying voltage to the coil 11.
  • the DC power supply 62 does not need to be stabilized, as the value at which the current ceases to increase and starts to decrease is determined by the current transducer and the control circuit 70, as a result, even if the value of the DC voltage produced varies, the peak current value will not.
  • the control circuit 70 comprises an oscillator 80, a latch or logic circuit 82 and a voltage comparator 84.
  • the oscillator 80 emits signals at the same frequency as desired for the current pulses. These signals trigger the closing of the switch 66, and thereby initiate current pulses.
  • the voltage comparator 84 emits a signal when the voltage coming from the current sensor 68 has reached a preset level corresponding to the desired peak current.
  • the signal from the oscillator 80 sets the latch 82, which, when set, drives the switch in conduction.
  • the signal from the comparator resets the latch, ending the conduction of the switch as the current has reached the preset value.
  • the control circuit 70 receives the current value measured by the current meter 68, and drives the switch 66 between the closed and open states.
  • the circuit 70 periodically drives the switch 66 to the closed state, and keeps it closed until the current value measured by current sensor 68 reaches the predefined peak value.
  • the switch 66 is closed, the whole voltage V supplied by the power supply is applied to the coil, which has inductance L and resistance R.
  • the current starts rising with a slope equal to V/L, then the slope decreases as the voltage developed across R is subtracted from V and decreases the voltage applied to L.
  • a photo of an oscilloscope graphing the waveform produce is illustrated in Figure 13 wherein the frequency is 15 Hz and the peak intensity of the magnetic field produced is 500 Gauss.
  • V was chosen accordingly to both R and L values, so as to give the wanted total rise time, less than 0.5 ms.
  • the circuit drives the switch open.
  • the current in the coil 1 1 cannot stop flowing, due to L.
  • the voltage across the coil 1 1 changes and becomes slightly negative; this brings the diode 64 into conduction.
  • the current continues to flow trough the diode 64, and the slope changes to downward, decaying exponentially because of the losses in R.
  • the current sensor 68 utilizes a shunt resistor 78 is provided.
  • the shunt resistor 78 is a resistor of low enough resistance so as to not interfere with the operating of the circuit to which it is series connected. It is of known resistance and the voltage developed across it by the flowing current can be used as a measure of the current value. This information is then relayed to the control circuit 70.
  • a conductive layer 14 is connected to ground and is disposed between the coil 11 and the target member, a second current sensor 82 is disposed between the conductive layer 14 and ground.
  • the second current sensor 82 is coupled to a switch 84 disposed such that when said switch 84 is open, the current to the pulse control and generation system 22 is interrupted.
  • the conductive layer 14, the sensor, 82 and the switch 84 act as a distributed ground fault interrupt.
  • Some embodiments of the present invention include a variety of additional features.
  • a means may be provided for verifying that the pulse current are effectively flowing through the coil, and for lighting a LED on the front panel if they are flowing. This is mainly to ensure that the coil is connected and is not broken.
  • Other alarms and indicators may be provided whereby the user may be alerted to problems within the device.
  • the control circuit 70 temporarily suspends device operation, and upon reconnection or restart, the device will resume operations at the point in the cycle at which it was terminated.
  • Various means for resetting the device may be provided including the depression of a combination of buttons or a dedicated reset button.
  • Adjustable controls on the front panel may also be provided for selecting the frequency of the pulses and peak current value, though one skilled in the art will readily appreciate that in some embodiments the frequency and intensity of the pulses need not be adjustable.
  • Two timers may be provided, either separate from or integrated into the control circuit 70, one whereby the user can control the duration of a therapeutic session and a second whereby usage is limited to the prescribed time per day.
  • the memory required to preserve the timers is powered by a 9 volt battery or other power storage device during an interruption of the primary power supply to the device.
  • the first timer for the user to program the time duration of a therapy session.
  • the user may have an input control to select the duration of the therapy session, and a start/stop pushbutton to start and temporarily stop the therapy.
  • the device will automatically stop.
  • a user timer configured according to one embodiment may provide 6 preset time selections, ranging from 10 to 60 minutes in duration at 10-minute increments.
  • similar indicator lights may be employed to indicate the time remaining in a selected treatment session. The selection may be changed during operation and takes immediate effect. In some embodiments, light emitting diode indicators may be lit to indicate the selected time.
  • a second timer may be set by the factory, physician, clinician, or retailer to prevent the user from having the device running for more than 2 hours total in each 20-hour period.
  • Other embodiments may be set to different time periods and limits based on testing indicating the efficacy and safety of various periods of exposure.
  • the 20-hour time period is preserved in memory even in the event of a power failure to the device.
  • Results from clinical tests of one embodiment of the present invention and its efficacy in treating osteoarthritis knee pain are summarized in the following tables. Subjects pain was measured by primary end points including: modified WOMAC index for knee osteoarthritis, and 100mm VAS as assessed both after 4 weeks of treatment sessions.
  • the test was a randomized, placebo controlled, double-blind trial to evaluate efficacy of the investigational device in reducing pain and improving function in persons with osteoarthritis of the knees.

Abstract

La présente invention concerne un système de stimulation électromagnétique pulsée d'une cible. Ce système comprend un unité de commande et de génération d'impulsion, un appareil d'élément conforme couplé à cette unité de commande et de génération d'impulsion et, un matériau conducteur isolé placé à l'intérieur de cet appareil, ce matériau conducteur isolé étant placé à proximité de la cible et produisant un champ magnétique pulsé lorsqu'une impulsion électrique est envoyée à travers ce matériau conducteur par l'unité de commande et de génération d'impulsion.
PCT/US2004/013978 2003-05-05 2004-05-05 Procede et appareil de stimulation electromagnetique de nerf, de muscle et de tissus anatomiques WO2004098700A2 (fr)

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Cited By (4)

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WO2010109298A1 (fr) * 2009-03-23 2010-09-30 Politecnico Di Milano Système de pompe circulatoire abdominale
CN107412954A (zh) * 2017-07-25 2017-12-01 上官秀丰 一种强磁脉冲理疗器
CN109976199A (zh) * 2017-12-27 2019-07-05 高权 一种信号发生装置以及具有信号发生装置的设备
WO2022254015A1 (fr) * 2021-06-04 2022-12-08 Deleo Système de stimulation électromagnétique

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US4757804A (en) * 1986-08-25 1988-07-19 Lti Biomedical, Inc. Device for electromagnetic treatment of living tissue

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US4757804A (en) * 1986-08-25 1988-07-19 Lti Biomedical, Inc. Device for electromagnetic treatment of living tissue

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010109298A1 (fr) * 2009-03-23 2010-09-30 Politecnico Di Milano Système de pompe circulatoire abdominale
CN107412954A (zh) * 2017-07-25 2017-12-01 上官秀丰 一种强磁脉冲理疗器
CN109976199A (zh) * 2017-12-27 2019-07-05 高权 一种信号发生装置以及具有信号发生装置的设备
CN109976199B (zh) * 2017-12-27 2024-05-07 高权 一种信号发生装置以及具有信号发生装置的设备
WO2022254015A1 (fr) * 2021-06-04 2022-12-08 Deleo Système de stimulation électromagnétique
FR3123571A1 (fr) * 2021-06-04 2022-12-09 Deleo Système de stimulation électromagnétique

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