Abstract:
A knee brace for continual electro-acupuncture stimulation system comprises: a first electrode configured to electrically coupled to acupuncture point Heting “(S  156 )”; a second electrode configured to electrically coupled to acupuncture point “Spleen  10  ”; a third electrode configured to electrically coupled to acupuncture point “Stomach  34  ”; a fourth electrode configured to electrically coupled to acupuncture point “Hsiyen (S  145 )”; a fifth electrode configured to electrically coupled to acupuncture point “Stomach  35  ”; a sixth electrode configured to electrically coupled to acupuncture point “Bladder  40  ”. The first, second, and third electrodes are connected to a polarity of voltage, and the fourth, fifth, and sixth electrodes are connected to an opposite polarity of voltage, such that electric currents flow in a body of a patient to achieve analgesia, cartilage repair and regeneration in the knee joint.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority under 35 U.S.C. §120 as a continuation-in-part application of U.S. patent application Ser. No. 12/626,034 filed on Nov. 25, 2009 which claims priority under 35 U.S.C. §120 as a continuation application of U.S. patent application Ser. No. 11/747,075 filed on May 10, 2007 which in turn claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 60/799,263, filed May 10, 2006. The disclosure of all priority applications is hereby incorporated by reference in their entireties. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to continual electro-acupunctural stimulation and more specifically to knee braces for continual electro-acupunctural stimulation for in vivo and in situ therapeutic effects on analgesia and tissue regeneration and repair. 
     BACKGROUND OF THE INVENTION 
     In China, the insertion of acupuncture needles into acupuncture points to treat diseases has been practiced for at least 2,000 years. The addition of electricity or electro-acupuncture was documented in a French text as early as in 1825. Its author, Chevalier Solardiere, claimed that when static electricity, generated by rubbing a silk scarf against ebony was discharged into the inserted acupuncture needles, the electrical discharge enhanced the therapeutic results of acupuncture. In the 1950&#39;s, Chinese acupuncture practitioners used an automobile starter motor as a continuous source of electrical stimuli to acupuncture needles to enhance the efficacy and efficiency of the acupuncture therapeutic effects. Since that original motor-starter stimulator, various electronic stimulators have been employed with a plethora of therapeutic claims. The stimuli delivered by these stimulators to the acupuncture points through the acupuncture needles have varied in frequency, voltage, current, pulse shape and duration. The duration of the electrical stimuli is generally very brief, such as ranging from 10 to 60 minutes. One such system and method can be found in U.S. Pat. No. 7,200,444 to Gavronsky et al., herein incorporated by reference in its entirety. 
     SUMMARY OF THE INVENTION 
     According to one embodiment of the invention, a knee brace for continual electro-acupuncture stimulation system comprises a first electrode configured to electrically couple to acupuncture point “Heting (S  156 )”, a second electrode configured to electrically couple to acupuncture point “Spleen  10 ”, a third electrode configured to electrically couple to acupuncture point “Stomach  34 ”, a fourth electrode configured to electrically couple to acupuncture point “Hsiyen (S  145 )”, a fifth electrode configured to electrically couple to acupuncture point “Stomach  35 ”, a sixth electrode configured to electrically couple to acupuncture point “Bladder  40 ”. The first, second, and third electrodes are connected to a polarity of voltage, and the fourth, fifth, and sixth electrodes are connected to an opposite polarity of voltage, such that electric currents flow in a body of a patient to be treated for analgesia, cartilage repair and regeneration in the knee joint. 
     According to one embodiment of the invention, the electrodes of the knee brace are connected to an external controller unit enclosing a battery for supplying electric currents, a switch for turning the electric power of the battery on and off, and an electro stimulator for modulating the electric currents supplied by the battery. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is further illustrated in the following Figures. 
         FIGS. 1A-1B  show an overview of the continual electro-acupuncture stimulation system applied to produce analgesia, repair and/or regeneration of cartilage in the knee joint. 
         FIG. 2  illustrates a schematic diagram of a knee brace for continual electro-acupuncture stimulation system, according to an embodiment of the invention. 
         FIG. 3  illustrates a schematic diagram of a knee brace for continual electro-acupuncture stimulation system having a controller unit external to the brace, according to an embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Disclosed herein are devices and methods for analgesia and tissue repair and regeneration that does not require major surgery or a research-intensive stem cell approach and, at the same time, it is a non-invasive fast-acting treatment. The disclosed treatment is inexpensive when compared to surgical treatments. This recent biomedical breakthrough is a vast improvement over current treatment modalities, whether measured by cost or by time-to-heal effectiveness. 
     According to some embodiments of the invention, disclosed is a set of electrodes applied externally to certain selected acupuncture points for treating osteoarthritis including pain, joint stiffness, limitation of range of motion and limitation of overall function through the use of sub-sensory unidirectional voltage or current pulses. The electrical stimulus can be applied, in one embodiment, through six electrodes disposed onto the appropriate anatomical points of the patient such that it is close to the cartilaginous surfaces of an osteoarthritic joint. The electrotherapeutic stimulation restores the normal electromagnetic field enveloping the joint. For the cartilage tissue, the field stimulates chondrocyte functioning, and increases synthesis of proteoglycans and Type II collagen molecules in cartilage resulting in the efficient and efficacious repair of damaged cartilage. The devices and methods disclosed herein can be more efficient and efficacious than, for example, transcutaneous electrical stimulation through non-specifically placed surface electrodes. Articular cartilage and fibrocartilage repair can potentially take place after three to four weeks of continuous treatment. 
     Most current treatments for advanced osteoarthritis involve surgically invasive interventions, such as total knee replacement or total hip replacement. These treatments are costly and for some they can be quite perilous in terms of patient morbidity and mortality. Post surgical recovery requires significant time and total joint replacement surgery presents complications or compromised functionality for about 10% of patients. There are few alternative treatments that have shown effectiveness compared to conservative as well as standard surgical practices. Those that do exist require months of treatment. To the contrary, the device and method shown can provide a fast-acting non-invasive alternative treatment that works continuously or substantially continuously and, in most cases, will permit daily patient ambulation, which will further patient rehabilitation. 
       FIGS. 1A-1B  illustrates some possible advantageous locations to produce analgesia, repair and/or regeneration of cartilage  9  in the knee joint  50 .  FIG. 1A  is a lateral schematic view of the knee  50  illustrating acupuncture points “Hsiyen (S  145 ) point”, also known as “eye of the knee”  8 , “Heting point (S  156 )”  4 , and “Bladder  40 ”  6 .  FIG. 1B  is a frontal schematic view of the knee illustrating other advantageous acupuncture points for knee analgesia, repair, and/or regeneration of cartilage, such as “Hsiyen (S  145 )”  8 , “Spleen  10 ”  7 , “Heting point (S 156 )”  4 , “Stomach  34 ”  11 , and “Stomach  35 ”  13 . These points can be located by one of ordinarily skill in the art as described below: 
     “Hsiyen (S  145 )”  8 : Locate this point with knee flexed, at the lower border of the patella in the depression lateral to the patellar ligament. 
     “Stomach  34 ”  11 : Locate this point with knee flexed, two finger-widths (comparable to the patients fingers size) above the medio-superior border of the patella on the bulge of the medial portion of the quadriceps femoris muscle. 
     “Stomach  35 ”  13 : Locate this point in the depression, medial to the patellar ligament, locating the point with the knee flexed. 
     “Spleen  10 ”  7 : Locate this point with the knee flexed, measure two thumb widths (comparable to the patients thumb size) above the latero-superior border of the patella. 
     “Heting (S  156 )”  4 : Locate this point at the depression of the midpoint of the superior patellar border. 
     “Bladder  40 ”  6 : Locate this point at the midpoint of the transverse crease of the popliteal fossa, between the tendons of the biceps femoris and semitendinosus muscles. 
     The nature and location of various points and meridians used in Chinese acupuncture are described in many texts, such as the following; the book “Acupuncture in Medical Practice”, Louise O. Wensel, M.D., published 1980 by Reston Publishing (A Prentice Hall Company) is particularly noted; the book “Acupuncture, The Ancient Chinese Art of Healing and How it Works Scientifically”, Felix Mann, M.B. published 1973 by Vintage Books, a division of Random House, New York; the book “Chinese Acupuncture and Moxibustion”, Revised Edition, Chief Editor Cheng Xinnong published 1999 by Foreign Languages Press, Beijing, and; the book “A Manual of Acupuncture” by Peter Deadman et al. published 2001 by Journal of Chinese Medicine Publications. All of these four texts are herein incorporated by reference in their entirety. Appropriate corresponding anatomical landmarks can be selected in order to produce the desired clinical result. 
       FIG. 2  shows a schematic diagram of a knee brace  100  for continual electro-acupuncture stimulation system, according to an embodiment. Knee brace  100  has a patella-shaped hole  102  for anchoring the knee brace to the knee joint of a patient when knee brace  100  is fixed to the knee. Knee brace is fixed referring to an arrow  104  showing the up direction of the knee. Knee brace  100  comprises non-invasive electrodes  204 ,  207 , and  211  grouped as a group  220 , and non-invasive electrodes  208 ,  213 , and  206  grouped as a group  222 . For example, group  220  may be connected to positive voltage, and group  222  may be connected to negative voltage from the same source such as a battery or batteries. It is also possible to connect group  220  to negative voltage and group  222  to positive voltage. 
     When knee brace  100  is fixed to the knee: electrode  204  is configured to electrically coupled to acupuncture point “Heting (S  156 )”  4 ; electrode  207  is configured to electrically coupled to acupuncture point “Spleen  10 ”  7 ; electrode  211  is configured to electrically coupled to acupuncture point “Stomach  34 ”  11 ; electrode  208  is configured to electrically coupled to acupuncture point “Hsiyen (S  145 )”  8 ; electrode  213  is configured to electrically coupled to acupuncture point “Stomach  35 ”  13 ; electrode  206  is configured to electrically coupled to acupuncture point “Bladder  40 ”  6 . 
     In an embodiment, when knee brace  100  is fixed to the knee, and the electric power is turned on, electric currents flow from acupuncture points “Heting (S  156 )”  4 , “Spleen  10 ”  7 , and “Stomach  34 ”  11 , to acupuncture points “Hsiyen (S  145 )”  8 , “Stomach  35 ”  13 , and “Bladder  40 ”  6 , inside the body of a patient to achieve analgesia, cartilage repair and regeneration in the knee joint. 
     Knee brace  100  has at least one strap to fix it to the knee. For example, knee brace  100  may have three straps  106 ,  108 , and  110  to wrap around knee brace  100  for fixing knee brace  100  to the knee. Straps  106 ,  108 , and  110  may have fastening components  112  for fastening knee brace  100 . Fastening components  112  may be a hook-and-loop fastener material, such as Velcro. 
     In an embodiment, knee brace  100  may include a battery  120  or batteries for supplying electric currents that flow through electrodes  204 ,  207 , and  211 , to electrodes  208 ,  213 , and  206 . Knee brace  100  may also include a switch  122  for turning the electric power of battery  120  on and off. The electric current from battery  120  is modulated by an electro stimulator  124 . The electric current modulated by electro stimulator  124  is distributed to electrodes  204 ,  207 , and  211  through a wire  126 , and then is collected from electrodes  208 ,  213 , and  206  through wire  128 . The electrodes may be made of conducting rubber, conducting silicone, or the like, or metal. In an embodiment, battery  120 , switch  122 , electro stimulator  124 , wires  126  and  128  may be embedded internally inside the knee brace. 
       FIG. 3  shows an embodiment where battery  120 , switch  122 , and electro stimulator  124  are enclosed in a controller unit  132  disposed externally to knee brace  100 , according to the disclosure. Other parts of  FIG. 3  are the same as  FIG. 2 . Controller unit  132  may be disposed in a pocket on knee brace  100 . Controller unit  132  may be connected to wires  126  and  128  using wires  134  and  136 , respectively, through a connector  130 . In some implementation, wires  134  and  136  may be long enough for keeping controller unit  132  far from knee brace  100 , for example, keeping controller unit  132  in a pocket of shirt, dress, or pant worn by the patient. Wires  126  and  128  may be embedded in knee brace  100 , and only connector  130  may be extending from knee brace  100 . 
     One of ordinary skill in the art will readily appreciate that a wide variety of fastening materials can be substituted for hook-and-loop fastener material for any or all of the disclosed components. Such fastening materials include, for example, snap fasteners, button fasteners, adhesives, tapes, buckle fasteners, locks, magnetic fasteners, custom made orthotics, and the like. 
     In some embodiments, electrical stimulator  124  can have the following settings: 0-5 milliamp current, 0-18V voltage, 1-100 Hz frequency, 1-99% duty cycle. The pulse waveform is preferably square; however, other morphologies such as triangular, sinusoidal, sawtooth, spike, j-spike, and the like can also be used depending on the desired clinical result. Electrical stimulator  124  is preferably battery powered; hoWever, electrical stimulator  124  could also be powered by AC outlet using an adaptor (not shown). The battery may be rechargeable. In an embodiment, a square wave of 2 Hz frequency may be applied. 
     However, it is to be understood that the above construction is only an idealization for ease of illustration, and in reality any of the components could vary in any one or more or any combination of size, shape, size distribution, shape distribution, or other geometric or orthotic characteristics. 
     In one embodiment, a patient with a disease to be treated, such as osteoarthritis of the knee, is selected. A general overall health assessment for electrotherapy, a focused gait examination, and a Visual Analog Scale (VAS) pain assessment is conducted to better assess the patient&#39;s pre-treatment pain. The patient can receive diagnostic bi-planar X-rays and/or Tesler 3 or 7 magnetic resonance imaging (MRI) exams with a patient body weight preload. If the patient is determined to be a suitable candidate, treatment is commenced by fixing the knee brace to patient&#39;s knee In one embodiment, the electrodes at points “Heting (S  156 )”  4 , “Spleen  10 ”  7 , and “Stomach  34 ”  11  serve as positive electrodes. The electrodes at points “Bladder  40 ”  6 , “Stomach  35 ”  13 , and “Hsiyen (S 145 )”  8  serve as negative electrodes. In another embodiment, the polarity may be reversed. 
     The electrodes are operably connected to electrical stimulator  124 . The power of the stimulator is then increased to a threshold level of sensation by the patient, and then decreased to a sub-sensory level for patient comfort, as well as potentially advantageously promoting analgesia and cartilage repair and/or remodeling. In an embodiment, the practitioner will be able to determine with an appropriate treatment duration depending on the desired clinical result and patient progress through regular serial follow-up visits, physical examinations, pain assessments, radiographs and/or MRIs. In an embodiment, the patient may self-administer the use of the device. 
     In some embodiments, the electrical stimulator power remains above a threshold sensory level during treatment. In other embodiments, the stimulator power remains sub-sensory throughout the time the electrodes are operably connected to the stimulator. In still other embodiments, the stimulator power can cycle between sensory and sub-sensory power levels during treatment. Candidates for total joint replacement may benefit by undergoing nearly continuous stimulation over an extended period of time. In some embodiments, the system is left in place for 2-5 weeks as a therapeutic trial before contemplating more invasive surgical procedures. In some embodiments, the system can be applied for at least about 1, 2, 3, 5, 7, 10, 14, 21, 28, 35, 42, 60, 90, 120 or more days depending upon the desired clinical result. The various fastening mechanisms disclosed herein can advantageously assist in providing secure implantation of the system for extended periods of time. 
     The electrical stimulator may be turned on continuously for 24 hours each day. However, in some embodiments, it may be preferable that the electrical stimulator be only activated for only a portion of each day, for example, at least about 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20 hours or more each day, and not be active when the patient is more actively moving the area to be treated in activities such as standing, walking, sleeeping, or the like. In some embodiments, the electrical stimulator may have a mercury switch automatically that turns off the stimulator when the patient stands and resumes stimulation when the patient is seated or in a recumbent position. In other embodiments, the stimulator can be turned on and off manually. 
     While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and sub-combinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof. For the disclosed methods, the steps need not necessarily be performed sequentially. 
     The terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification and the claims. Rather, the scope is to be determined entirely by the following claims, which are to be construed in accordance with established doctrines of claim interpretation. The present specification and figures are accordingly to be regarded as illustrative rather than restrictive.