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Fully Implantable Miniature Neurostimulator for Gastrointestinal Nerve and/or Muscle Stimulation as a Therapy for Gastrointestinal Motility and Sphincteric Disorders

IP.com Disclosure Number: IPCOM000030566D
Publication Date: 2004-Aug-17

Publishing Venue

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Abstract

A small implantable stimulator(s) having at least two electrodes is small enough to be implanted adjacent to a gastrointestinal nerve and/or muscle for the stimulation treatment of gastrointestinal motility and/or sphincteric disorders. The small stimulator provides a means of stimulating a nerve structure(s) and/or muscles when desired, and may be implanted via a minimal surgical procedure.

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Fully Implantable Miniature Neurostimulator for Gastrointestinal Nerve and/or Muscle Stimulation as a Therapy for Gastrointestinal Motility and Sphincteric Disorders

Background

                    The present invention generally relates to implantable stimulator systems and methods, and more particularly relates to implantable stimulator systems and methods utilizing one or more implantable microstimulators as a therapy for gastrointestinal motility and sphincteric disorders.

                    A microminiature implantable electrical stimulator, referred to herein as a microstimulator, and known as the BION® microstimulator, has been developed (by Advanced Bionics of Valencia, California) to overcome some of the disadvantages of traditional leaded systems.  The standard BION device is a leadless microstimulator, as the implantable pulse generator and the electrodes have been combined into a single microminiature package.  A standard configuration of the BION device is a cylinder that is about 3 mm in diameter and between about 2 and 3 cm in length.  This form factor allows the BION device to be implanted with relative ease and rapidity, e.g., via endoscopic or laparoscopic techniques.  With this configuration, the BION device consists of only two electrodes: a reference, or indifferent, electrode at one end and an active electrode at the other end.  In addition, with this configuration, electrical signals delivered to nerves travel away from the stimulation location along the nerve fibers in both directions.

                    The present invention provides a means of chronically stimulating the nerves and muscles that contribute to the function of the gastrointestinal system with the BION device.  Electrical stimulation of such targets may provide significant therapeutic benefit in the management of gastrointestinal motility disorders and sphincteric disorders.

                    Gastrointestinal disorders may be due to a number of underlying etiologies and may manifest a number of symptoms.  Gastrointestinal motility disorders and sphincteric disorders may be caused by musculature that fails to contract, musculature that fails to relax, or musculature that fails to contract and relax in a coordinated fashion.  An understanding of these various diseases requires some description of the anatomy and the physiology of the gastrointestinal system.

                    The gastrointestinal (GI) system consists of the gastrointestinal tract and associated glandular organs that produce secretions.  The major structures of the gastrointestinal tract are the mouth, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, and ileum), large intestine (colon), rectum, and anus.  Associated glandular organs include the salivary glands, liver, gallbladder, and pancreas.

                    Most of the GI tract is covered with a thin outermost layer known as the serosa (adventitia), which is primarily connective tissu...