This invention is in the field of methods and devices to be used by human subjects to decrease or eliminate pain without the use of ingested or injected drugs or implanted medical devices.
It is well known that there are literally millions of patients throughout the world who suffer pain in various parts of their bodies. Three of the most frequent sites for pain are: (1) foot pain caused by chemotherapy or diabetic neuropathy; (2) shoulder pain often resulting from a tear or inflammation of the rotator cuff; and (3) lower back pain caused by a large variety of medical problems, particularly associated with the spine and the nerves surrounding the vertebrae. Although there are many pain medications to reduce the level of pain experienced by such patients, these drugs often are not sufficiently palliative and they typically can cause serious side effects.
One early invention to utilize magnetic fields to treat pain is described by Robert R, Holcomb in International Publication Number: WO 91/15263. The invention described in that document consists of four magnetic coils that are placed in the back of a chair or under a table where the patient's back would be exposed to the magnetic field. A DC current is placed through the four coils which results in an unchanging magnetic field to be experienced by the patient.
In U.S. Pat. No. 6,402,678, Robert E. Fischell, et al describe a device to be placed on the head which can eliminate or reduce the pain of migraine headaches by the application of an intense magnetic pulse. This device was approved by the US FDA on May 22, 2014 and is currently in use to treat patients with migraine headaches. The Fischell, et al device operates by charging capacitors to a high voltage and then discharging them into a magnetic coil to create a magnetic pulse as high as one Tesla in intensity. By Faraday's law, this changing magnetic pulse creates an electrical pulse within the brain that has been shown to eliminate migraine headaches. Because it takes about 45 seconds to charge the condensers from a battery within this Transcranial Magnetic Stimulation (TMS) device, the rate of applying magnetic pulses to the brain is extremely slow; i. e., only one pulse in about 45 seconds. Even at that, the time rate of change of the magnetic field within the brain results in an electrical current in the neurons of the brain which eliminates most migraine headaches. However, the application of more pulses per unit time could result in a more effective treatment for the relief of pain from other parts of the human body such as the feet, the shoulders or the back.
An existing system that is currently available to treat lower back pain is called TENS which is an acronym for Transcutaneous Electrical Nerve Stimulator. This device has two adhesive covered electrodes that are pasted onto the skin along the lower back. The device can then be turned on and adjusted so that the pain in the skin is acceptable while some electrical pulses enter the body in the vicinity of the spine where they can provide some relief for lower back pain. However, it would be highly advantageous to use a system that could introduce higher intensity electrical pulses into that region without causing any skin pain. That can be accomplished with TransCutaneous Magnetic Stimulation or TCMS as described herein.
The present invention is a means and method to apply TransCutaneous Magnetic Stimulation (TCMS) to relieve pain in a human subject without the use of an analgesic drug. The TCMS system consists of a computer-controlled electrical pulse generator that would typically be plugged into a wall electrical socket and would provide repeated magnetic pulses through the skin at a site where a patient was experiencing pain. The magnetic pulses would be created by means of a pulse of electric current through a magnetic coil that has been placed in close proximity to the patient's skin at that location where the patient is experiencing pain.
For different locations on the patient's body, the magnetic coil would have a different shape. For example, for the treatment of lower back pain, a racetrack shaped coil could be placed at that region of the lower back (typically the lumbar or sacral region) where the pain is felt by the patient. The racetrack shaped coil could be attached to and placed within a specially designed belt that would place that coil in close proximity to the skin on the lower back with the buckle for the belt being located at the abdomen as is typical for belts used with male trousers. It should also be understood that pressure or inflammation of a nerve in the back can also result in pain in the buttocks and into the leg and feet. Thus, a device located on the lower back to apply TCMS in that region could also be used to reduce or even eliminate referred pain in regions of the body below the location of that nerve in the back that causes the pain in the extremities.
Another application of the present invention is a magnetic coil that is placed around the shoulder for the treatment of rotator cuff pain or any other source of shoulder pain. The unique shape for the shoulder magnetic coil would ideally be in the form of two separate coils, one on each side of the shoulder. The coil portion on each side of shoulder would cause magnetic fields that are in the same direction so as to enhance the magnetic field acting upon the tissue in the shoulder. This type of coil could also be used to wrap around the neck or the knee or any other generally cylindrical portion of a human body to reduce pain in that part of the body.
Still another application of the present invention is a coil to be used for the treatment of foot and/or ankle pain. This type of coil could be extended around the ankle to reduce pain in both the foot and the ankle. This unique design for a magnetic coil would be particularly advantageous for those patients who suffer foot and ankle pain resulting from chemotherapy or from diabetic neuropathy.
Still another application of the present invention is a flat, circular coil with an adhesive placed onto one surface so that it could be removably attached to the patient's skin at any location on a human body.
It should be understood that the electrical pulse generator would typically get its power by being plugged into a wall electrical socket. However, the use of a primary or rechargeable battery for the electrical pulse generator is certainly possible. Still further, the design described herein could obtain its electrical power from a cigar lighter electrical receptacle as located in an automobile or a truck.
The waveform for treatment would be a magnetic pulse with a rise time between 10 and 1,000 microseconds. A pulse length of approximately 200 microseconds would be ideal for this purpose. The stimulation pulse rate would optimally be at a rate between 0.1 Hz and 10 Hz with an optimum frequency being approximately 0.5 to 1.0 Hz. It is also conceived that the wave form could be approximately half of one sine wave or a square wave to optimize the relief of pain. The peak amplitude for the magnetic pulses at the patient's skin should be at least 0.1 Tesla with an optimum magnetic pulse strength at the skin being between 0.5 and 3.0 Tesla.
It should also be understood that the present invention could be used for the relief of pain that extends through a major or limited portion of a human body such as the pain of fibromyalgia, spinal stenosis, arthritis, pinched or otherwise damaged nerves, vascular inflammation, diabetic neuropathy, pain caused by chemotherapy or any other source of pain in a human body.
Thus one object of the present invention is to provide a means and method to treat pain of a human patient by the application of high intensity magnetic pulsations through the patient's skin at a location where those magnetic pulsations create subcutaneous electrical currents that result in a decrease of the patient's level of pain.
Another object of this invention is to optimize the size and shape of the magnetic coil to best fit at that specific location on the patient's body where the pain is to be treated.
Still another object of this invention is to have two magnetic coils on each side of a body part with each of the two coils enhancing the magnetic field to which that body part is exposed.
Still another object of this invention is a method to diminish the pain caused by diabetic neuropathy.
Still another object of this invention is a method to diminish the pain caused by chemotherapy.
Still another object of this invention is a method to diminish the pain caused by pressure or inflammation on the nerves in the back in the vicinity of the spine, the pain being observed in the back or below that region into the buttocks, legs and feet.
Still another object of this invention is the use of a racetrack shaped coil to be within a covering that has belt loops that can be attached around the patient's abdomen by means of a typical belt, the belt being selected to have a length ideally suited for the girth of a particular patient.
Still another object of this invention is to have an electrical current pulse generator designed to be used with a variety of shapes and sizes of magnetic coils to provide the electrical current pulses that generate the desired magnetic pulses when attached to any one of a number of different designs for magnetic coils, some of which designs are described in detail herein.
Still another object of this invention is to have an electrical current pulse generator that indicates to the operator of the generator (whether it is a medical practitioner or the patient himself/herself) as to several attributes of the treatment about to be obtained with that electrical current pulse generator.
These and other objects and advantages of this invention will become obvious to a person of ordinary skill in this art upon reading the detailed description of this invention including the associated drawings as presented herein.
Although the optimum electrical pulse generator system 20 would get its power as shown in
The electrical pulse generator system 20 would include conventional circuitry to generate a pulse waveform, a sinusoidal wave form, a square wave waveform or any other wave form that is found to be effective for stimulation of nerves. The frequency of the pulses could be anything between 0.1 Hz and 10 Hz with an optimum pulse rate being approximately 0.5 to 1.0 Hz. The pulse amplitude generated by the magnetic coil 10 could be anything between 0.1 Tesla and 5.0 Tesla with an optimum magnetic pulse peak intensity being between approximately 0.5 and 3.0 Tesla. When pulses are used for TCMS, the pulse rise time could be between 10 and 1,000 microseconds with an optimum pulse rise time being approximately 175±50 microseconds.
Surrounding the magnetic coil 14 would be a coil covering member 15 that could be formed from a plastic material or from certain cloth materials. It should also be understood that the wires 14 could be adhesively attached to the outer layer 12 or there could be a plastic fill material situated between each turn of the wires of the magnetic coil 14.
The present invention conceives of the magnetic coil system 10 being made available to the patient in at least three different shoe sizes with as many as 10 different shoe sizes being envisaged as being possible for this product.
An important aspect of the present invention is the design of the back of the magnetic coil system 30 as shown in
It should be understood that the design of the TCMS system 30 to treat lower back pain allows the system 30 to be applied while a patient is working at his/her desk or even if the patient is lying in bed. Thus the pain relief can be applied at most times when it would be truly convenient for such a patient to utilize such a device.
It should be understood that any of the hollow wires shown in
A useful and novel attribute of the system shown in
Although the electrical pulse generator system 20 as described herein is always shown to have knobs 22 and 23 to adjust the intensity and frequency of the electrical current pulses emanating from that device, it should be understood that it could also have fixed values of frequency and pulse amplitude so that adjustment knobs would not be needed. It should also be understood that the magnetic pulse generator 21 could have an electrical switch to turn it to ON or OFF or it could turn on automatically when plugged into a wall socket.
A patient who has significant pain in at least one of the regions described herein may very well wish to transport his TCMS system from home to work and back or to take each system on travel. To that end, it is envisaged that each of the magnetic coil systems 10, 30 and 40 as described herein, and also the magnetic coil system 20 could have a special carrying case that has wheels and a pull-up handle as is commonly used for suitcases. The electrical pulse generator system 20 may also be designed with wheels and a pull-up handle so as to make moving it from one place to the other less difficult.
The electrical current pulse generator 50 of
When the WAIT light 52 has gone to its off state, the operator can then: 1) rotate the knob 53 to set the number of seconds between each pulse as indicted in the box 54; 2) rotate the knob 55 to set the total number of pulses that the operator feels will be sufficient to ease the pain of the patient to be treated as indicated in box 56; and 3) rotate the knob 57 to adjust the amplitude of the magnetic pulses that are expected to be delivered just below the patient's skin as indicated in box 58. After the operator feels that each of the settings are optimum for a particular patient and for a particular magnetic coil design, then the operator can press the button 60 (which turns on a green light surrounding that button) to start the treatment with a series of magnetic pulses into the patient's tissues. Using the settings as shown in
There are many advantages to this type of design for a generator that is used to create electrical current pulses that enter magnetic coils to create magnetic pulses into a patient's body. It is anticipated that some patients would be more comfortable and gain more pain relief if the time between pulses was either less than or more than 4 seconds. Thus, the operator could use any number of seconds for the treatment between approximately 1.0 second and (let us say) 10 seconds. Later research might even show that pulse periods either less than one second or greater than 10 seconds may be beneficial for some pain patients.
In a similar manner, it might be shown that more or less than 225 pulses would be optimum for some patients for some levels of pain in different parts of a human body. It is also possible that magnetic pulse peak amplitudes greater than or less than 1.6 Tesla may be advantageous for some patients.
The advantages of the novel features of the electrical current pulse generator 50 as described herein are that it teaches that each of these most significant parameters can be adjusted to optimize pain relief for different patients and for different body locations. The settings shown in
Another significant advantage of the design of the face plate for the electrical current pulse generator 50 shown in
Although the use of the electrical current pulse generator 50 as described herein consistently discusses its use for human patients, it should be understood that this equipment can also be useful to reduce the pain suffered by animals such as dogs, cats or horses or any other animal that has pain. To that end, wherever herein the word “patient” is used, that patient could also be considered to be any animal that is suffering from a condition of pain.
Various other modifications, adaptations and alternative designs are of course possible in light of the teachings as presented herein. Therefore it should be understood that, while still remaining within the scope and meaning of the appended claims, this invention could be practiced in a manner other than that which is specifically described herein.
This is a continuation-in-part application based upon the prior patent application entitled “Transcutaneous Magnetic Stimulation for the Treatment of Pain,” Ser. No. 14/304,309 filed with the USPTO on Jun. 13, 2014.
Number | Date | Country | |
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Parent | 14304309 | Jun 2014 | US |
Child | 14338439 | US |