| Percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineering -> Monitor Keywords |
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  Percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineeringUSPTO Application #: 20070265680Title: Percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineering Abstract: The invention includes an electro-acupuncture stimulation system for in vivo and in situ analgesia and tissue repair and regeneration. Electrodes, which can be acupuncture needles, are percutaneously implanted that deliver a pulsed electrical current that creates an electrical field, which envelopes the targeted tissue and restores cell-generating homeostasis to the affected tissue and thereby promotes analgesia and tissue re-growth in otherwise debilitated or deteriorating tissue. Methods and apparatuses are also disclosed that may include a needle locking system and acupuncture-needle assemblies for long-term in situ electrical stimulation. (end of abstract) Agent: Knobbe Martens Olson & Bear LLP - Irvine, CA, US Inventor: Y. King Liu USPTO Applicaton #: 20070265680 - Class: 607 46 (USPTO) The Patent Description & Claims data below is from USPTO Patent Application 20070265680. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001]This application claims priority under 35 U.S.C. .sctn.119 to U.S. Provisional Application No. 60/799,263, filed May 10, 2006, the disclosure of which is incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION [0002]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'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. To Applicants' knowledge, none have sought to percutaneously implant the acupuncture needles for a prolonged period of time. This invention describes such a system. FIELD OF THE INVENTION [0003]This invention relates to electro-acupunctural stimulation and more specifically to percutaneous nearly continual electrical stimulation of appropriately inserted acupuncture needles to specific known anatomical and acupuncture points to achieve certain in vivo and in situ therapeutic effects on analgesia and tissue regeneration and repair. SUMMARY OF THE INVENTION [0004]According to one embodiment of the invention, disclosed is an electro-acupuncture system, in which the acupuncture needles are percutaneously implanted through an acupuncture guide tube. The shank of a specially designed and constructed acupuncture-needle is a male screw thread. Once the needle is in place, a small hollow cylinder with a corresponding female thread in the inside diameter is used to fixate an antibacterial O-ring against the skin to prevent infection. The O-ring is placed in a cutout at one end of the hollow cylinder while the other end has a tapered section with rings and longitudinal sections trisecting the rings perpendicularly. A plastic winged butterfly fixture is molded to consist of a bendable piece of soft plastic with pieces of wire embedded as flexible reinforcement. Velcro is attached to one side of the butterfly surface. Near the tail of the other side of the butterfly is a metallic cup. The metallic cup has a slightly tapered internal inside diameter so that the shank of the implanted needle can be interference-fitted to the cup. A small wire is tied and soldered solidly to the cup and is then connected to an electrical stimulator. Both sides of the electrical stimulator are fitted with Velcro. In this fashion, when all the needles are fixated and in place, a double sided Velcro band is used to secure all the plastic butterflies snugly. The electrical stimulators are affixed to the first Velcro band. A one-sided Velcro band is then wrapped around the first band to complete the installation. [0005]In some embodiments, disclosed is a customized electrode in-dwelling stimulation assembly. This assembly is embodied in an expandable sleeve that form-fits over the knee and is secured with Velcro fixations. The assembly includes a battery-powered miniature electrical stimulator and is housed with butterfly snaps and wire leads that attach to a set of pre-inserted electrodes that allow the delivery of electrical stimulus, which envelopes joint cartilage within a custom tissue repairing electromagnetic field. [0006]In one embodiment, disclosed is a securable percutaneous electro-acupunctural system that includes at least one needle comprising an elongate body, proximal end, and distal end, the needle having a fastener component disposed on the elongate body; and a needle-securing element configured to lock said implanted needles in situ. The needle is preferably retained in a desired anatomical landmark, such as an acupuncture point. In some embodiments, the elongate body of the needle comprises a male screw threaded portion. The needles can have a diameter of between about 30 to 34 gauge. The needles can have a length between about 8 mm to 2.5 cm. The needle-securing element can include a female-threaded portion that is configured to interface with the male threaded portion of the needle. The system can further include an O-ring at a distal end of the needle-securing element. The O-ring can include an antimicrobial agent. The needle-securing element can have a press-fit outer surface. The system can further include a fixator cup sized to at least partially cover the needle-securing element. The fixator cup can also include a press-fit inner surface configured to attach to the press-fit outer surface of the needle-securing element. In some embodiments, the outside surface of the cup is tied or soldered with a ring, which is connected to an insulated wire. The wire is connected to one of the positive or negative leads of a jack, the jack having both the positive and negative leads connected to it; the jack operably connected to an output port of an electronic stimulator. The system can also include a skin overlaying component having a first side and a second side, the skin overlaying component configured to fit over the fixator cup and the contour of surrounding skin of a patient over the first side of the skin overlaying component. The skin overlaying component can include embedded flexible wires to facilitate bending to fit the contour of the surrounding skin of a patient. The second side of the skin overlaying component can include fastener material. The system can also include an electrical stimulator. The electrical stimulator can be at least partially covered by a fastener material; the fastener material of the electrical stimulator configured to attach to the fastener material of the second side of the skin overlaying component. In some embodiments, the system further includes a strap with a first side and a second side; the first side of the strap comprising fastener material configured to attach to the fastener material of the electrical stimulator. [0007]Also disclosed herein is a method of treating a patient. The method includes the steps of providing a plurality of needles; selecting one or more treatment sites on a patient; inserting the needles percutaneously into the treatment site of the patient; providing an electrical stimulator; connecting the needles to the stimulator, and activating the stimulator; wherein the needles remain percutaneously inserted in the treatment site for at least 24 hours. In some embodiments, the step of activating the stimulator involves increasing the power on the stimulator to a threshold level of sensation by the patient, and decreasing the power until it becomes sub-sensory to the patient. The treatment site can be a joint, such as a knee. In some embodiments, the treatment site comprises one or more acupuncture points selected from the group consisting of Heting (S156), Spleen 10, Stomach 34, Bladder 40, Stomach 35, and Hsiyen (S145). In some embodiments, the needles remain percutaneously inserted in the treatment site for at least a twenty-four hour period. The needles can be operably connected to a needle-securing element configured to keep the needle in its originally inserted position. The patient may exhibit signs and/or symptoms of osteoarthritis. The duration of the percutaneous electrical stimulus is governed by the severity of the osteoarthritis disease being treated. For example, Grade I osteoarthritis, might include electrical stimulus over the course of one week versus a treatment period of three or more weeks for Grade III osteoarthritis. For all treatments, clinical judgment will determine the duration of electrical stimulus period. In some embodiments, the treatment sites include the points Heting (S156), Spleen 10, Stomach 34, Bladder 40, Stomach 35, and Hsiyen (S145) and the needles inserted into the treatment sites Heting (S156), Spleen 10, and Stomach 34 serve as positive electrodes while the needles inserted into treatment sites Bladder 40, Stomach 35, and Hsiyen (S145) serve as negative electrodes. In some embodiments, the stimulator is activated for at least about 4 hours per day. BRIEF DESCRIPTION OF THE DRAWINGS [0008]The invention is further illustrated in the following Figures. [0009]FIGS. 1A-1B show an overview of the acupuncture-needle assembly system applied to produce analgesia, repair and/or regeneration of cartilage in the knee joint. [0010]FIG. 2 illustrates how the percutaneous acupuncture-needle assembly is fixated against the skin, according to some embodiments of the invention. [0011]FIG. 2A is an exploded view of an acupuncture needle assembly, according to some embodiments of the invention. [0012]FIGS. 3A-B further illustrates the inter-relationship between the skin overlaying component and the fixator cup. In this illustration, the skin overlaying component is bent so as to fit the contours of the skin. This is also shown in FIG. 2. [0013]FIGS. 4A-B illustrates how the Velcro strap is used to bind the three acupuncture points: Bladder 40, Stomach 35 together with the Special Point (S145), Hsiyen or "the Eye of the Knee". These three acupuncture points are connected to the negative terminals of the electronic stimulator. [0014]FIGS. 5A-B illustrates how the Velcro strap is used to bind the three acupuncture points: Spleen 10, Stomach 34 and the Special Point (S156) Heting or "the Crown of the Crane". These three acupuncture points are connected to the positive terminals of the electronic stimulator. [0015]FIG. 6 shows how the electronic stimulator is attached to the double-sided Velcro by the one-sided Velcro. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0016]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 minimally invasive fast-acting treatment. The disclosed treatment is inexpensive when compared to surgical treatments and faster acting than current non-invasive devices. This recent biomedical breakthrough is a vast improvement over current treatment modalities, whether measured by cost or by time-to-heal effectiveness. [0017]According to some embodiments of the invention, disclosed is an externally implanted electrotherapeutic in-dwelling system for treating osteoarthritis including pain, joint stiffness, limitation of range of motion and limitation of overall function through the use of percutaneous sub-sensory unidirectional voltage or current pulses. The electrical stimulus can be applied, in one embodiment, through six 30-34 gauge needle electrodes inserted into 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 chrondrocyte 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. [0018]Most current treatments for advanced arthritis, such as 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 minimally invasive alternative treatment that works continuously or substantially continuously and, in most cases, will permit daily patient ambulation, which will further patient rehabilitation. Continue reading... Full patent description for Percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineering Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Percutaneous continual electro-acupuncture stimulation system for in vivo and in situ tissue engineering patent application. Patent Applications in related categories: 20080195176 - Raynaud's conditions - This document provides methods and materials for treating Raynaud's conditions such as Raynaud's syndrome, Raynaud's phenomenon, and Raynaud's disease. 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