Patent Publication Number: US-2010131025-A1

Title: Apparatus and method for treating diabetic neuropathy and peripheral vascular pathologies

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/118,069 filed Nov. 26, 2008. 
    
    
     BACKGROUND 
     Treatments for diseases such as diabetic neuropathy and peripheral arterial disease and related conditions such as diabetic wounds are difficult to treat and few conventional therapies provide significant relief or improvement. 
     Diabetic neuropathy is manifested in a variety of ways including, for example, loss of coordination and balance, extreme sensitivity to touch, numbness or insensitivity to pain or temperature, tingling, burning, or prickling, sharp pains or cramps, atrophy of muscles, wounds that do not heal well and become easily infected, erectile or sexual dysfunction, loss of bladder or bowel control, abnormal sweating with inability to tolerate changes in temperature, abnormal blood pressure control, causing lightheadedness when standing up, trouble digesting food, double vision, aching behind the eye, inability to focus the eye, pain in the front of the thigh, paralysis on one side of the face (Bell&#39;s palsy), problems hearing, severe pain in pelvis or lower back, and chest or abdominal pain sometimes mistaken for angina, heart attack, or appendicitis. 
     Peripheral arterial disease (PAD) is a circulatory problem in which arteries have become sclerotic, thereby reducing blood flow to the limbs. Peripheral arterial disease causes the extremities, e.g., the legs, to have inadequate blood flow, which causes symptoms, most notably leg pain when walking, a condition called intermittent claudication. Peripheral arterial disease is likely to be a sign of widespread accumulation of fatty deposits in the arteries (atherosclerosis), which may be reducing blood flow to the heart and brain as well. Strictly speaking, peripheral arterial disease refers to a problem with any of the arteries outside, or peripheral to, the heart, but the term is commonly used to describe circulatory problems in the limbs or pelvis. Intermittent claudication is characterized by muscle pain or cramping in the legs or arms that is triggered by a certain amount of activity, such as walking, but disappears after a few minutes of rest. The location of the pain depends on the location of the clogged or narrowed artery. Calf pain is most common. The severity of intermittent claudication varies widely. Pain from this condition can range from mildly bothersome to debilitating. Severe intermittent claudication can impair one&#39;s ability to function and engage in any physical activity. Other signs and symptoms of peripheral arterial disease include, leg numbness or weakness, cold legs or feet, sores on the toes, feet or legs that won&#39;t heal, a change in the color of the legs, hair loss on the feet and legs, and changes in the nails. If peripheral arterial disease progresses, pain may even occur at rest or when lying down. This is called ischemic rest pain. It may be intense enough to prevent sleep or wake from sleep. One may be able to temporarily relieve the pain by hanging the legs over the edge of the bed or by walking around the room. The most common cause of peripheral arterial disease is atherosclerosis. In atherosclerosis, fatty deposits (plaques) build up in the artery walls and reduce blood flow. As noted, peripheral arterial disease can lead to open sores that don&#39;t heal, injury, or infection of the feet and legs, especially in persons who also have diabetes. Critical limb ischemia (CLI) is the extreme case of this condition and can cause tissue death (gangrene), sometimes requiring amputation of the affected limb. Stroke and heart attack are among the more serious and most common complications that accompany peripheral arterial disease. Atherosclerosis causing symptoms of peripheral arterial disease is not limited to the legs. Fat deposits also build up in arteries supplying the heart and brain. 
     Improved methods for treating these disease conditions would be highly desired. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a bottom plan view of a therapeutic cuff in accordance with an embodiment of the present invention. 
         FIG. 2  is a top plan view of a therapeutic cuff of  FIG. 1 . 
         FIG. 3  is a side cross-sectional view of the therapeutic cuff of  FIG. 1  taken through line  3 - 3 . 
         FIG. 4  is a front view of legs and a lower torso of a subject wearing several therapeutic cuffs as described herein. 
         FIG. 5  is a back view of the subject of  FIG. 4 . 
         FIG. 6  is a schematic view of an operating control device for the therapeutic cuff of the present invention. 
         FIG. 7  is a side view of the control device of  FIG. 6 . 
         FIG. 8  is a diagram of a subject&#39;s head having a therapeutic cuff of the present invention secured thereabout. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention is directed to an apparatus and method for treating a person afflicted with diabetic neuropathy, diabetically-associated wound or peripheral arterial disease (PAD). The apparatus comprises one or more cuffs constructed from straps or bands which can be secured about a limb or body part of a patient (e.g., leg and/or arm) and which are constructed with low intensity (cold laser) diodes for applying laser light and with electrical electrodes for applying electrical pulses, respectively, to the patient&#39;s limbs at the locations of the cuffs. This could be used as a pad with the diodes embedded in the pad to hold it in place which would not require the cuff. 
     Each therapeutic cuff of the apparatus comprises at least one laser diode and at least one electrode. Preferably there are a plurality of laser diodes and at least two electrode pads disposed on the cuff. One embodiment of the therapeutic cuff is shown in  FIG. 1 , and designated as therapeutic cuff  10 . The therapeutic cuff  10  is shown constructed of a flexible band of material  12  having an inner surface  14  and outer surface  16 . Externally positioned on the inner surface  14  are one or more electrodes  18  ( FIG. 1  shows three electrodes  18 ) and a plurality of laser diodes  20  which are positioned around and between the electrodes  18 . Each electrode  18  is connected to an embedded internal electrical lead (not shown) which supplies an electrical current and each laser diode  20  is connected to an embedded internal fiber optic lead (not shown) which supplies coherent laser light to each laser diode  20 . The electrical leads and fiber optic leads are preferably bundled together in a cable  22  which extends from a terminal portion or intermediate portion of the band of material  12 . The therapeutic cuff  10  preferably further comprises a fastening system such as pins, clips, snaps, or hook and loop fasteners such as are known in the art as Velcro® fasteners. For example, the inner surface  14  may have a hook and loop fastener  24  at a terminal portion thereof, and a complementary hook and loop fastener  26  on the outer surface  16  of the band of material  12  for connecting the therapeutic cuff  10  about the limb or body part. 
     In a preferred embodiment, the electrode  18  is a portion of a Transcutaneous Electrical Nerve Stimulation unit (or TENS unit) which is an electrical device which produces mild electrical signals to stimulate nerves through unbroken skin. The TENS unit comprises a plurality of electrodes, a pulse generator, a small transformer and frequency and intensity controls. Examples of TENS devices and power and intensity levels which may be used herein are shown in U.S. Pat. Nos. 3,817,254 and 6,751,506, which are hereby expressly incorporated by reference herein in their entirety. TENS units are commercially available. 
     In a preferred embodiment, each laser diode  20  is a low intensity laser diode. The preferred laser light wavelength range is 400-1400 nm, and more preferably 650-950 nm and the irradiation rate is generally 1-1500 mW/cm 2  and more preferably 10-100 mW/cm 2 . The laser irradiation may be pulsed or continuous and may comprise only one, or both, of the transverse magnetic (TM) polarization mode or the transverse electric (TE) polarization mode of the optical signal. Other optical and power parameters which may be employed during use of the laser diode  20  of the present invention may be found in U.S. Pat. Nos. 5,445,146 and 6,494,900 which are hereby expressly incorporated herein by reference in their entireties. 
     Shown in  FIGS. 4 and 5  is a subject  30  having a lower torso  32 , a right leg  34  and a left leg  36 . A plurality of the therapeutic cuffs  10  are positioned on each of the right leg  34  and left leg  36  of the subject  30  in positions on the thigh area  38 , the cuff area  40 , and the upper ankle area  42 . Preferably the therapeutic cuffs  10  are placed over arteries, veins and lymph nodes or vessels in the right leg  34  and left leg  36 . In an alternative embodiment, therapeutic cuffs  10  are placed only on the right leg  34  or the left leg  36  (not both) or may be suitably placed on an arm or the arms of a subject (not shown) along with those on the legs or in substitution thereof. 
     The positions of the therapeutic cuffs  10  in  FIGS. 4 and 5  are considered to be merely exemplary of a variety of specific positions which may be used. Preferably the therapeutic cuffs  10  are positioned so as to place the electrodes  18  and laser diodes  20  over or adjacent arteries, veins, and lymph vessels in the limbs. Further, the electrodes  18  may be positioned over muscles in the limbs. 
     The therapeutic cuff  10  of the present invention in an alternate embodiment could be secured about (1) the head, for treating migraine headaches, TMJ, stress headaches (e.g.,  FIG. 8 ), (2) the back of the neck, for treating neck pain, (3) the back, for treating back pain, (4) shoulder for treating shoulder pain and tightness, (5) Chest for treating chest pain and tightness of muscles, (6) Wrist for treating pain and tightness, (7) Hand for treating pain and tightness, (7) Hip for treating hip pain and tightness, (8) Knee for treating knee pain and tightness. Units will be designed to accommodate the specific body part that will be treated for the desired effect. 
     Without wishing to be held to theory, it is thought that the low intensity laser irradiation from the laser diodes  20  has its effect in strengthening arterial and venous vessel walls and constriction thereof thereby reducing swelling in the limbs (edema) thereby resulting in an acute improvement in blood flow and a reduction in pain and swelling. When laser is used alone, these effects tend to be temporary, i.e., the improvements generally last only a few days or weeks. Further, without wishing to be bound by theory, electrical stimulation alone appears to cause stimulation of muscles in and surrounding blood vessels thereby helping to increase blood flow therethrough. 
     When both laser light and electrical stimulation is used in the present invention, the laser and electrical stimulation act synergistically to cause significantly longer lasting improvements, even to the point that subjects having severe cases of diabetic neuropathy and PAD who could not walk prior to the treatment contemplated herein are able to walk and even exercise after treatment. For example, when laser or electrical stimulation is used alone there may be an increase of 10 mm of basal blood pressure, whereas when laser and electrical stimulation are used simultaneously together (as contemplated herein) they act synergistically, for example, the resulting increase in blood pressure can be from 25-75 mm. 
     In a preferred embodiment, as shown in  FIGS. 4-7 , the cables  22  which lead from each therapeutic cuff  10  are operatively connected to an operating control and power device  50  which is clipped to a belt  52  or other device by a clip  54  (or other holding device). The control and power device  50  has a power source such as a battery or AC current and which has an optical signal generator for providing the laser signals to each therapeutic cuff  10 . Power controls are represented on control device  50  by dials  56  which can be turned to regulate the power and/or intensity of the optical and/or electrical signals wherein the power or intensity level is shown in LED windows  58 . An on/off button switch  50  is represented as well as signal buttons  62  which can be turned on or off to cause the optical and/or electrical signals to be emitted in specific configurations such as “pulsing”, “continuous”, “massaging”, “tapping”, or other desired modes. 
     Treatment protocols vary depending on the particular affliction experienced by the subject and the magnitude or severity thereof. For example, a single treatment may last for 5 to 30 minutes, and may be repeated one to several times/day, or week. For example, a subject may be given a single treatment or several each day for two to four weeks or until relief is attained. The intensity of the laser and electrical signals may be those described elsewhere herein. The entire content of each patent or published application cited herein is expressly incorporated herein by reference in its entirety. 
     The present invention is not to be limited in scope by the specific embodiments described herein, since such embodiments are intended as but single illustrations of one aspect of the invention and any functionally equivalent embodiments are within the scope of this invention. Indeed, various modifications of the methods of the invention in addition to those shown and described herein will become apparent to those skilled in the art form the foregoing description.