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WO2008063486A2 - Procédé et système de restriction gastrique pour un traitement de troubles alimentaires - Google Patents

Procédé et système de restriction gastrique pour un traitement de troubles alimentaires Download PDF

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Publication number
WO2008063486A2
WO2008063486A2 PCT/US2007/023809 US2007023809W WO2008063486A2 WO 2008063486 A2 WO2008063486 A2 WO 2008063486A2 US 2007023809 W US2007023809 W US 2007023809W WO 2008063486 A2 WO2008063486 A2 WO 2008063486A2
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WIPO (PCT)
Prior art keywords
synthesized
approximately
neurosignal
satiety
neuro
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WO2008063486A3 (fr
Inventor
Robert T. Stone
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NEUROSIGNAL TECHNOLOGIES Inc
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NEUROSIGNAL TECHNOLOGIES Inc
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Priority claimed from US11/982,651 external-priority patent/US20080161875A1/en
Application filed by NEUROSIGNAL TECHNOLOGIES Inc filed Critical NEUROSIGNAL TECHNOLOGIES Inc
Publication of WO2008063486A2 publication Critical patent/WO2008063486A2/fr
Publication of WO2008063486A3 publication Critical patent/WO2008063486A3/fr
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0026—Anti-eating devices using electrical stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes

Definitions

  • the present invention relates generally to medical methods and systems for treating eating disorders. More particularly, the invention relates to a gastric restriction method and system for treatment of eating disorders that includes means for generating and transmitting synthesized neurosignals that substantially correspond to neuro-electrical signals that are generated in the body and produce a satiety effect in the body.
  • Obesity is asserted to be the cause of approximately eighty percent of adult onset diabetes in the United States, and of ninety percent of sleep apnea cases. Obesity is also a substantial risk factor for coronary artery disease, stroke, chronic venous abnormalities, numerous orthopedic problems and esophageal reflux disease. More recently, researchers have documented a link between obesity, infertility and miscarriages, as well as post menopausal breast cancer.
  • Various "electrical stimulation" apparatus, systems and methods have also been employed to treat compulsive overeating and obesity.
  • the noted systems and methods typically include the transmission of a pre-programmed electrical pulse or signal to a subject to induce a satiety effect, e.g., feeling of fullness.
  • Illustrative are the systems and methods disclosed in U.S. Pat. Nos. 5,263,480 and 6,587,719, and U.S. Pat. Application Publications 2005/0033376 Al and 2004/0024428 Al .
  • a gastric restriction method and system for treating eating disorders that includes means for generating and transmitting synthesized neurosignals to a subject's body that substantially correspond to neuro-electrical coded signals that are generated in the body and produce or induce a satiety effect in the body.
  • It is another object of the invention to provide a gastric restriction method and system for treating eating disorders that includes means for constricting the stoma of the stomach and timed transmission of synthesized neurosignals to a subject's body that substantially correspond to neuro-electrical signals that are generated in the body and produce a satiety effect in the body. It is another object of the invention to provide a gastric restriction method and system for treating eating disorders that includes means for constricting the stoma of the stomach manual transmission of synthesized neurosignals to a subject's body that substantially correspond to neuro-electrical signals that are generated in the body and produce a satiety effect in the body.
  • the gastric restriction method for treating eating disorders generally comprises includes the steps of (i) generating a synthesized neurosignal that substantially corresponds to a neuro-electrical signal that is generated in a body and produces a satiety effect in the body, (ii) constricting the stoma of the stomach, and (iii) transmitting the synthesized neurosignal to the subject.
  • the synthesized neurosignal is transmitted at predetermined time intervals.
  • the synthesized neurosignal is transmitted manually. In another embodiment, the synthesized neurosignal is transmitted manually and at predetermined time intervals.
  • the synthesized neurosignal has a first region having a first positive voltage in the range of approximately 100 - 1500 mV for a first period of time in the range of approximately 100 - 400 ⁇ sec and a second region having a first negative voltage in the range of approximately -50 mV to -750 mV for a second period of time in the range of approximately 200-800 ⁇ sec.
  • the first positive voltage is approximately 800 mV
  • the first period of time is approximately 200 ⁇ sec
  • the first negative voltage is approximately -400 mV
  • the second period of time is approximately 400 ⁇ sec.
  • the synthesized neurosignals has a repetition rate in the range of approximately 0.01 - 4 KHz.
  • the gastric restriction method for treating eating disorders includes the steps of (i) capturing neuro-electrical signals that are generated in the body and produce a satiety effect in the body, (ii) generating a synthesized neurosignal that substantially corresponds to at least one of the captured neuro-electrical signals, and (iii) transmitting the synthesized neurosignal to the subject.
  • the gastric restriction method for treating eating disorders includes the steps of (i) capturing neuro-electrical signals that are generated in the body and produce a satiety effect in the body, (ii) generating a synthesized neurosignal that substantially corresponds to at least one of the captured neuro-electrical signals, (iii) constricting the stoma of the stomach, and (iv) transmitting the synthesized neurosignal to the subject.
  • the gastric restriction system for treating eating disorders generally comprises (i) a gastric band adapted to constrict the stoma of the stomach, (ii) a processor adapted to generate at least a first synthesized neurosignal that substantially corresponds to a neuro-electrical signal that is generated in the body and produces a satiety effect in the body, and (iii) a signal transmitter adapted to be in communication with the subject's body for transmitting the first synthesized neurosignal to the subject.
  • the system includes a remote transponder that is adapted to transmit control signals to the processor.
  • the remote transponder is further adapted to remotely monitor the control parameters of the processor.
  • FIGURE IA is an illustration of a portion of a human torso, showing the gastrointestinal tract
  • FIGURE IB is an illustration of a human stomach
  • FIGURE 2 is a schematic illustration of one embodiment of a synthesized neurosignal of the invention
  • FIGURE 3 is a schematic illustration of one embodiment of a food intake control system, according to the invention.
  • FIGURE 4 is a schematic illustration of another embodiment of a food intake control system, according to the invention.
  • FIGURE 5 is a schematic illustration of another embodiment of a food intake control system, according to the invention.
  • FIGURE 6 is a perspective view of a prior art gastric band that is adapted to constrict the stoma of the stomach;
  • FIGURE 7 is another perspective view of the gastric band shown in FIGURE 6, illustrating an expanded state of the inflatable member
  • FIGURE 8 is a further illustration of the partial human torso shown in FIGURE IA, illustrating the placement of the gastric band shown in FIGURE 6 on the neck region of the stomach;
  • FIGURE 9 is a perspective view of one embodiment of a gastric restriction system, comprising the gastric band shown in FIGURE 6 and one embodiment of the control system shown in FIGURE 4, according to the invention;
  • FIGURES 10 and 1 1 are perspective views of additional embodiments of the gastric restriction system shown in FIGURE 9, according to the invention.
  • FIGURE 12 is a perspective view of yet another embodiment of the gastric restriction system shown in FIGURE 9, according to the invention.
  • FIGURE 13 is a perspective view of the gastric restriction system shown in FIGURE 9, showing an expanded state of the inflatable member;
  • FIGURE 14 is a further illustration of the partial human torso shown in FIGURE 1, illustrating the restrictive placement of the gastric restriction system shown in FIGURE 9 on the neck region of the stomach, according to the invention;
  • FIGURE 15 is a further illustration of the partial human torso shown in FIGURE 1, illustrating the "non-restrictive" placement of the gastric restriction system shown in FIGURE 9 on the neck region of the stomach, according to the invention.
  • FIGURE 16 is a front plan view of one embodiment of a gastric electrode positioning device, according to the invention.
  • patient and “subject”, as used herein, mean and include humans and animals.
  • substance and “satiety effect”, as used herein, mean a feeling of fullness experienced by a subject.
  • treating disorder means and includes, without limitation, compulsive eating and obesity, bulimia and anorexia nervosa.
  • targeting system means and includes the central nervous system, including the spinal cord, medulla oblongata, pons, cerebellum, midbrain, diencephalon and cerebral hemisphere, and the peripheral nervous system, including the neurons and glia.
  • plexus means and includes a branching or tangle of nerve fibers outside the central nervous system.
  • ganglion means and includes a group or groups of nerve cell bodies located outside the central nervous system.
  • vagus nerve and “vagus nerve bundle” are used interchangeably herein and mean and include one of the twelve (12) pair of cranial nerves that emanate from the medulla oblongata.
  • neuro-electrical signal means and includes a composite electrical signal that is generated in the body and carried by neurons in the body, including neurocodes, neurosignals and components and segments thereof, and generated neuro-electrical signals that substantially correspond thereto.
  • synthetic neurosignal means and includes an electrical signal made up of mathematical descriptors which, when applied to a animal nervous system elicit the same physiological response as a natural neuro-electrical signal elicits within the animal. In general, the amplitude and duration of synthesized neurosignals have key characteristics that are similar to action potentials found naturally in neurons; although their time-amplitude appearance may be different.
  • a synthesized neurosignal can be derived via various processes of synthesis, including, without limitation, time domain synthesis, frequency domain synthesis, bi-normal synthesis, and other conventional signal processing techniques.
  • time domain synthesis means synthesis or summation of components, which have an amplitude and duration as descriptive specifications of components of the signal which are linearly or non-linearly combined to form a composite signal.
  • frequency domain synthesis means synthesis or formation of a composite signal from elements that are specified as having a frequency, amplitude, and phase, which elements are combined either linearly or non-linearly to form the composite signal.
  • the term “synthesized satiety signal”, as used herein, means a synthesized neurosignal that produces or induces a satiety effect in a subject when transmitted thereto.
  • digestion means and includes all physiological processes associated with extracting nutrients from food and eliminating waste from the body.
  • gastrointestinal system means and includes, without limitation, the gastrointestinal tract and, hence, all organs and systems involved in the process of digestion.
  • the "gastrointestinal system” also includes the nervous system associated with the noted organs and systems.
  • Fig. IA there is shown an illustration of a typical gastrointestinal tract (designated generally "10").
  • the gastrointestinal tract 10 generally includes the oesophagus or esophagus 12, stomach 13, small intestines 15 and large intestines 16, which includes the cecum 17, colon 18 and rectum 19.
  • the stomach 13 includes the fundus region (or fundus) 14a and pyloric antrum (or antrum) 14b.
  • the brain regulates (or controls) feeding behavior and gastrointestinal function via electrical (or neuro-electrical) signals (i.e. action potentials), which are transmitted through the nervous system.
  • electrical or neuro-electrical signals
  • Short-term cues consist primarily of chemical properties of the food that act in the mouth to stimulate feeding behavior and in the gastrointestinal system and liver to inhibit food intake.
  • Short-term neuro-electrical (or satiety) signals which are associated with (or provided by) the short-term cues, are transmitted through the nervous system and impinge on the hypothalamus through visceral afferent pathways, communicating primarily with the lateral hypothalamic regions (or satiety centers) of the brain.
  • the effectiveness of short-term cues is modulated by long-term neuro-electrical signals that reflect body weight. These long-term signals are similarly transmitted through the nervous system.
  • adipocytes One important long-term neuro-electrical signal is the peptide leptin, which is secreted from fat storage cells (i.e. adipocytes). By means of this signal, body weight is kept reasonably constant over a broad range of activity and diet.
  • Action potentials are rapid and transient "all-or-none" nerve impulses.
  • Action potentials typically have an amplitude of approximately 100 millivolts (mV) and a duration of approximately 1 msec.
  • the neurosignal also includes an instruction set for proper organ and/or system function.
  • a neurosignal that controls gastrointestinal function would thus include an instruction set for the muscles of the colon and anus to perform an efficient elimination or retention of a stool bolus, including information regarding initial muscle tension, degree (or depth) of muscle movement, etc.
  • Neurosignals are thus signals that contain complete sets of information for control of organ function.
  • a nerve-specific signal or instruction i.e. simulated neurosignal, can be generated and transmitted to a subject to control gastrointestinal function and, hence, treat a multitude of digestive system diseases and disorders, including, but not limited to, bowel (or fecal) incontinence, constipation and diarrhea.
  • bowel or fecal
  • a simulated neurosignal can also be generated and transmitted to a subject to regulate food intake and, hence, treat various eating disorders, including, but not limited to, compulsive overeating and obesity, bulimia and anorexia nervosa. As discussed in detail in Co-pending U. S Application No.
  • the vagus nerve bundle which contains both afferent and efferent pathways, conducts neurosignals from the medulla oblongata to direct aspects of the digestive process, including the secretion of digestive chemicals, operation of the salivary glands and regulation of gastrointestinal muscles (e.g., puborectalis, puboccygeus and iliococcygeus muscles).
  • the vagus nerve bundle thus plays a significant role in mediating afferent information from the stomach to the satiety centers of the brain.
  • the present invention substantially reduces or eliminates the disadvantages and drawbacks associated with prior art systems and methods for treating eating disorders.
  • the method for treating eating disorders includes the step of transmitting at least one synthesized, i.e. simulated, neurosignal to a subject that substantially corresponds to or is representative of at least one neuro-electrical signal that is naturally generated in the body and produces a satiety effect in the body.
  • the synthesized neurosignal comprises a synthesized satiety signal that substantially corresponds to a short-term satiety signal that produces or induces a feeling a fullness.
  • the method for treating eating disorders includes the steps of (i) generating at least one synthesized satiety signal that substantially corresponds to a neuro-electrical signal that is generated in a body and produces a satiety effect in the body and (ii) transmitting the synthesized satiety signal to the subject.
  • a plurality of synthesized satiety signals are generated and transmitted to the subject.
  • the methods for treating eating disorders include the pre-programmed or timed transmission of the synthesized satiety signals.
  • a synthesized satiety signal or a plurality of synthesized satiety signals can be transmitted at set intervals at, near and/or between customary meal times to induce a feeling of fullness.
  • the transmission of the synthesized satiety signals can also be accomplished manually.
  • manual transmission of a signal is useful in situations where the subject has an earnest desire to control his or her eating behavior, but requires supportive measures due to insufficient will power to refrain from compulsive and/or damaging behavior.
  • the methods for treating eating disorders includes the step of capturing neuro-electrical signals from a subject's body that produce a satiety effect in the body.
  • the captured neuro-electrical signals can be employed to generate the synthesized neurosignals and/or synthesized satiety signals of the invention.
  • suitable neuro-electrical signals that produce a satiety effect in the body can be captured or collected from the vagus nerve bundle.
  • a preferred location is in the neck region of the stomach, which is enervated by the vagus nerve.
  • the captured neuro-electrical signals are preferably transmitted to a processor or control module.
  • the control module includes storage means adapted to store the captured signals.
  • the control module is further adapted to store the components of the captured signals (that are extracted by the processor) in the storage means according to the function performed by the signal components.
  • the stored neuro-electrical signals can subsequently be employed to establish base-line satiety signals.
  • the module can then be programmed to compare neuro-electrical signals (and components thereof) captured from a subject to base-line satiety signals and, in some embodiments, generate a synthesized neurosignal or satiety signal based on the comparison for transmission to a subject.
  • the captured neuro-electrical signals can be processed by known means to generate a synthesized neurosignal that produces a satiety effect in the body (i.e. a synthesized satiety signal).
  • the synthesized neurosignal substantially corresponds to or is representative of at least one captured neuro-electrical signal.
  • the synthesized neurosignal is similarly preferably stored in the storage means of the control module.
  • the synthesized neurosignals are processed as follows: Sinusoidal elements of a frequency, amplitude, and phase, which have been identified from the recorded neuro-electrical signals as indicative of a sense of satiety or "fullness", are combined into a composite signal.
  • the resulting spectrum of the synthesized neurosignal i.e. satiety signal
  • a synthesized neurosignal 100 of the invention which has been derived via the frequency domain synthesis disclosed above.
  • the signal 100 substantially corresponds to or is representative of neuro-electrical signals that are naturally generated in the body and produce a satiety effect in the body.
  • the signal 100 is thus referred to hereinafter as a "synthesized satiety signal”.
  • the synthesized satiety signal 100 preferably includes a positive voltage region 102 having a first positive voltage (Vi) for a first period of time (T
  • the first positive voltage (Vi) is in the range of approximately 100 - 1500 mV, more preferably, in the range of approximately 700 - 900 mV, even more preferably, approximately 800 mV;
  • the first period of time (Ti) is in the range of approximately 100 - 400 ⁇ sec, more preferably, in the range of approximately 150 - 300 ⁇ sec, even more preferably, approximately 200 ⁇ sec;
  • the first negative voltage (V 2 ) is in the range of approximately -50 mV to -750 mV, more preferably, in the range of approximately -350 mV to -450 mV, even more preferably, approximately -400 mV;
  • the second period of time (T 2 ) is in the range of approximately 200 - 800 ⁇ sec, more preferably, in the range of approximately 300 - 600 ⁇ sec, even more preferably, approximately 400 ⁇ sec.
  • the synthesized satiety signal 100 thus comprises a continuous sequence of positive and negative voltage (or current) regions or bursts of positive and negative voltage (or current) regions, which preferably exhibits a DC component signal substantially equal to zero.
  • the synthesized satiety signal 100 has a repetition rate (or frequency) in the range of approximately 0.01 - 4 KHz, more preferably, in the range of approximately 1 - 2 KHz. Even more preferably, the repetition rate is approximately 1.6 KHz..
  • the maximum amplitude of the synthesized satiety signal 100 is approximately 500 mV. In a preferred embodiment of the invention, the maximum amplitude of the synthesized satiety signal 100 is approximately 200 mV.
  • the effective amplitude for the applied voltage is a strong function of several factors, including the electrode employed and the placement of the electrode(s).
  • the synthesized satiety signals of the invention can be employed to construct "signal trains", comprising a plurality of synthesized satiety signals.
  • the signal train can comprise a continuous train of synthesized satiety signals or can included interposed signals or rest periods, i.e., zero voltage and current, between one or more synthesized satiety signals.
  • the signal train can also comprise substantially similar synthesized satiety signals, different synthesized satiety signals or a combination thereof.
  • the different synthesized satiety signals can have different first positive voltage (Vi) and/or first period of time (T]) and/or first negative voltage (V 2 ) and/or second period of time (T 2 ).
  • the synthesized satiety signal is derived via time domain synthesis. Details of a suitable time domain synthesis process and resulting synthesized neurosignals are set forth in Co-Pending Application No. 1 1/265,402; which is incorporated herein in its entirety.
  • the synthesized satiety signal (or signals) is accessed from the storage means and transmitted to the subject via a transmitter (or probe).
  • the applied voltage of the synthesized satiety signals of the invention can be up to 20 volts to allow for voltage loss during the transmission of the signals.
  • current is maintained to less than 2 amp output.
  • the control system 2OA includes a control module 22, which is adapted to receive neuro-electrical signals from a signal sensor (shown in phantom and designated 21) that is in communication with a subject, and at least one treatment member 24 that is adapted to communicate with the body.
  • the control module 22 is further adapted to generate synthesized satiety signals that substantially correspond to or are representative of neuro-electrical signals that are generated in the body and produce a satiety effect in the body, and transmit the synthesized satiety signals to the treatment member 24 at predetermined periods of time (or time intervals) and/or manually, i.e. upon activation of a manual switch (not shown).
  • control module 22 can be unique, i.e., tailored to a specific operation and/or subject, or can comprise a conventional device.
  • control module 22 and treatment member 24 are separate components or elements, which allows system 2OA to be operated remotely.
  • the module 22 is adapted to "wirelessly" transmit the synthesized satiety signals to the treatment member 24.
  • various wireless transmission means can be employed within the scope of the invention to effectuate the wireless transmission of signals from the module 22 to the treatment member 24.
  • the module 22 is adapted to transmit synthesized satiety signals to the treatment member 24 via at least one interconnect wire 23. Illustrative is the embodiment shown in Fig. 4, discussed below.
  • the treatment member 24 receives the synthesized satiety signals from the control module 22 and transmits the signals to the body.
  • the treatment member 24 can comprise an electrode, antenna, a seismic transducer, or any other suitable form of conduction attachment for transmitting the neuro-electrical satiety signals to a subject.
  • the treatment member 24 comprises an electrode system 25 (see Fig. 9). Referring now to Fig. 4, there is shown a further embodiment of a control system
  • the system 2OB is similar to system 2OA shown in Fig. 3. However, in this embodiment, the control module 22 and treatment member 24 are connected via interconnect wire 23.
  • the control system 2OB includes a remote transponder 27 that is adapted to transmit control signals to the module 22.
  • the transponder 27 is further adapted to monitor the control parameters of the module 22.
  • FIG. 5 there is shown yet another embodiment of a control system 2OC of the invention.
  • the control system 2OC similarly includes a control module 22 and a treatment member 24.
  • the system 2OC further includes at least one signal sensor 21.
  • the system 2OC also includes a processing module (or computer) 26.
  • the processing module 26 can be a separate component or a sub-system of a control module 22', as shown in phantom.
  • the processing module 26 preferably includes storage means adapted to store the captured neuro-electrical signals that produce a satiety effect in the body.
  • the processing module 26 is further adapted to extract and store the components of the captured neuro-electrical signals in the storage means according to the function performed by the signal components.
  • control system 2OC also includes a remote transponder 27 that is adapted to transmit controls signals to the module 22' and/or processing module 26.
  • transponder 27 is further adapted to monitor the control parameters of the module 22' and/or processing module 26.
  • the food intake control systems 2OA, 2OB, 2OC can be employed as stand-alone systems or employed in conjunction with (or as an integral component or sub-system of) another gastric device, such as a gastric band.
  • the food intake control systems 2OA, 2OB, 2OC can be employed in conjunction with or as an integral component (or sub-system) of various gastric bands.
  • gastric bands disclosed in U.S. Patent. No. 5,601 ,604, U.S. Application Nos. 1 1/1 18,452 (Pub. No. 2006/0247719), 1 1/296,258 (Pub. No. 2006/0129027) and 1 1/1 18,980 (Pub. No. 2006/0247722) and EP Application Nos. 1205148 and 1547549.
  • the gastric band (designated generally "30") includes a body portion 32 having an inner stomach facing surface 34.
  • the body portion 32 includes a head end 35 and a tail end 37 having one or more suture holes therein.
  • the gastric band 30 further includes a fill tube 36 (having a lumen therein) that is in fluid communication with an inflatable member 38, which is disposed on the inner surface 34.
  • the inflatable member 38 includes a lumen opening 37a that is adapted to receive the fill tube lumen.
  • the head end 35 of the body portion 32 includes a buckle 40.
  • the buckle 40 includes a pull tab 42 having a suture hole 44 integral therewith.
  • the gastric band 30 is placed in a circling position around the stomach 13; preferably, the neck region of the stomach 13. This is typically accomplished by pushing the fill tube 36 through a laparoscopic canula (not shown) in the patient's abdomen.
  • the end of the fill tube 36 is passed around the stomach 13, and the tail 37 is attached to the buckle 40, so that the buckle 40 and the tail 37 are irreversibly affixed to one another.
  • the adjustment of the stoma; the narrow opening in the stomach created by the band is calibrated by a second step after the band 30 is secured in this single position.
  • the interior of the inflatable member 38 is in fluid communication with an injection reservoir (not shown) by means of the fill tube 36.
  • the inflatable member 38 is gradually filled with saline, whereby the inflatable member 38 expands (see Fig. 7), and, as illustrated in Fig. 8, presses on and contracts the upper portion of the stomach wall underlying the band 30. This results in the decrease of the opening (stoma) inside the stomach 13 directly under the encircling band 30.
  • the gastric restriction system (designated generally "50A") includes the gastric band 30 and control system 2OB, discussed above.
  • control system 2OB any of the aforementioned food intake control systems, i.e. 2OA,
  • 2OB, 2OC, and equivalents thereof can be employed with the gastric restriction system 50A illustrated in Fig. 9.
  • the illustrated system 50A should thus not be construed as limiting the scope of the invention in any manner.
  • the transmitter of the gastric restriction system 50A comprises an electrode system, having at least two (2) electrodes.
  • the electrode system (designated generally "25”) includes two electrodes 25a, 25b that are disposed concentrically, i.e. longitudinally, on the exterior surface of the inflatable member 38.
  • the gastric restriction system (designated “5OB”) similarly includes electrodes 25a, 25b.
  • the electrodes 25a, 25b are, however, disposed in a substantially angular or perpendicular orientation on the inflatable member 38.
  • the electrode system 25 can also comprise a band of multiple electrodes, i.e. multiple pairs of electrodes. The band of multiple electrodes can similarly be disposed concentrically, or substantially angularly or perpendicular on the inflatable member 38 (see system 5OC in Fig. 1 1).
  • the electrode system 50 includes two interconnect wires 23a, 23b that are in communication with the electrodes 25a, 25b and the control module (not shown).
  • the electrodes 25a, 25b can comprise any suitable biocompatible, conductive material, such as platinum foil and platinum-iridium.
  • the electrode interconnect wires, i.e. 23 (see Fig. 4) and 23a, 23b (see Fig. 9) can be fabricated from any suitable biocompatible, conductive, and, preferably, low fatigue material, such as platinum-iridium.
  • control module can be disposed external of the body or implanted in the subject, e.g., secured to a wall of the stomach 13.
  • control module 22 is disposed on the gastric band 30 or an integral component thereof. Illustrative is the embodiment shown in Fig. 12, wherein the control module 22 is disposed on the buckle 40 of the gastric band 30.
  • the gastric system 50 would include a remote transponder 27, discussed above, to facilitate communications by and between the subject (and/or medical practitioner) and the control module.
  • the gastric restriction system 50 is initially positioned on the neck of the stomach.
  • the inflatable member 38 is then gradually filled with a predetermined amount of saline, whereby the inflatable member 38 expands (see Fig. 13), places the electrodes 25a, 25b in intimate contact with the neck of the stomach, and constricts the stoma of the stomach (see Fig. 14), during which time one or more synthesized satiety signals are transmitted to the subject.
  • the synthesized satiety signals are transmitted proximate the positioned system 50.
  • the synthesized satiety signals can be transmitted at pre-programmed set intervals and/or manually.
  • the gastric restriction system 50 can also effectively transmit synthesized satiety signals to the subject without inflating the inflatable member 38 and, hence, constricting the stoma of the stomach.
  • this can be achieved by "non-restrictively" positioning the gastric restriction system 50 on the neck of the stomach 13, whereby the electrodes 25a, 25b are placed in intimate contact with the neck of the stomach 13 (see Fig. 15).
  • various other non-restrictive electrode positioning techniques and devices can also be employed to position the electrodes at desired locations proximate the stomach.
  • the positioning device 60 comprises a thin, elongated band having an engagement end 65 and a securing end 67.
  • the securing end 67 preferably includes internal means for receiving and securing the engagement end 65.
  • the positioning device 60 further includes at least one, preferably, a plurality of highly elastic regions 62 that facilitate expansion of the device 60 while disposed on the neck of the stomach 13.
  • the highly elastic regions can be provided by various means.
  • the elastic regions can comprise regions of reduced area, thinner cross-section, corrugated regions, etc., and combinations thereof.
  • the highly elastic regions 62 comprise regions of reduced area.
  • the highly elastic regions comprise regions having thinner cross-sections.
  • the highly elastic regions comprise corrugated regions.
  • the electrodes can be disposed on the positioning device 60 in any operable location, whereby the electrodes are in contact with the neck of the stomach 13 when the positioning device is non-restrictively positioned thereon.
  • the illustrated positioning device 60 includes multiple electrodes 64. As illustrated in Fig. 16, the electrodes 64 are disposed in spaced regions of the device 60 between the highly elastic regions 62.
  • the method for treating eating disorders thus includes the steps of (i) generating a synthesized neurosignal that substantially corresponds to a neuro-electrical signal that is generated in a body and produces a satiety effect in the body and (ii) transmitting the synthesized satiety signal to the subject.
  • the synthesized neurosignal comprises a synthesized satiety signal.
  • the method for treating eating disorders includes the step of constricting the stoma of the stomach.
  • the synthesized neurosignal is transmitted at predetermined time intervals.
  • the synthesized neurosignal is transmitted manually. In another embodiment, the synthesized neurosignal is transmitted manually and at predetermined time intervals.
  • the synthesized neurosignal has a first region having a first positive voltage in the range of approximately 100 - 1500 mV for a first period of time in the range of approximately 100 - 400 ⁇ sec and a second region having a first negative voltage in the range of approximately -50 mV to -750 mV for a second period of time in the range of approximately 200-800 ⁇ sec.
  • the first positive voltage is approximately 800 mV
  • the first period of time is approximately 200 ⁇ sec
  • the first negative voltage is approximately -400 mV
  • the second period of time is approximately 400 ⁇ sec.
  • the synthesized neurosignal has a repetition rate in the range of approximately 0.01 - 4 KHz.
  • the method for treating eating disorders includes the steps of (i) capturing neuro-electrical signals that are generated in the body and produce a satiety effect in the body, (ii) generating a synthesized neurosignal that substantially corresponds to at least one of the captured neuro-electrical signals, and (iii) transmitting the synthesized neurosignal to the subject.
  • the synthesized neurosignal comprises a synthesized satiety signal.
  • the method for treating eating disorders includes the step of constricting the stoma of the stomach.
  • a single synthesized neurosignal or a plurality of synthesized neurosignals can be transmitted to the subject in conjunction with one another.
  • the system for treating eating disorders in accordance with one embodiment of the invention, generally comprises (i) a processor adapted to generate at least a first synthesized neurosignal that substantially corresponds to a neuro-electrical signal that is generated in the body and produces a satiety effect in the body, and (ii) a signal transmitter adapted to be in communication with the subject's body for transmitting the first synthesized neurosignal to the subject.
  • the system in another embodiment, includes a gastric band that is adapted to constrict the stoma of the stomach.
  • the system includes a signal sensor that is adapted to be in communication with the subject's body for sensing neuro-electrical signals that are generated in the body and transmitting the sensed signals to the processor.
  • system includes a remote transponder that is adapted to transmit control signals to the processor.
  • remote transponder is further adapted to remotely monitor the control parameters of the processor.
  • a 45 year old female suffers from morbid obesity. She has been overweight since a first pregnancy, and her weight is now in excess of 200 percent of her ideal weight. She suffers from hypertension and sleep apnea, which her physician believes are directly related to her weight problem.
  • the patient consults with a physician and dietician to work out a diet and walking regimen for long-term weight loss. In coordination with this regimen, the patient has a gastric restriction system, such as system 50 (discussed above), implanted in her body.
  • the gastric restriction system is designed to generate and transmit synthesized neurosignals that correspond to neuro-electrical signals that derive from the neck of the stomach that elicit a feeling of fullness or satiety in the brain.
  • the patient monitors her weight weekly. It is expected that the patient will have periodic visits to her primary care physician for adjustment in the gastric band, if necessary, and timing and duration of the synthesized signals. It is also anticipated that the patient will remain on the exercise and diet regimen during treatment.
  • the present invention provides numerous advantages. Among the advantages are the provision of a method and system for treating eating disorders having: • Enhanced effectiveness;

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Abstract

L'invention concerne un procédé pour traiter des troubles alimentaires, comportant les étapes consistant à générer un signal de satiété neuroélectrique qui correspond sensiblement à un signal neuroélectrique qui est généré dans le corps et produit un effet de satiété dans le corps, à resserrer la stomie de l'estomac, et à transmettre le signal de satiété neuroélectrique au sujet.
PCT/US2007/023809 2006-11-21 2007-11-14 Procédé et système de restriction gastrique pour un traitement de troubles alimentaires Ceased WO2008063486A2 (fr)

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US86096506P 2006-11-21 2006-11-21
US60/860,965 2006-11-21
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US11/982,651 US20080161875A1 (en) 2006-11-21 2007-11-01 Gastric restriction method and system for treatment of eating disorders

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2318089A4 (fr) * 2008-07-11 2011-08-10 Gep Technology Inc Appareil et procédés minimalement invasifs pour un traitement de l'obésité
US8214049B2 (en) 2007-07-25 2012-07-03 Intrapace Inc. Gastric stimulation systems and methods utilizing a transgastric probe
US8239027B2 (en) 2001-05-01 2012-08-07 Intrapace, Inc. Responsive gastric stimulator
US8715181B2 (en) 2009-04-03 2014-05-06 Intrapace, Inc. Feedback systems and methods for communicating diagnostic and/or treatment signals to enhance obesity treatments
US8934976B2 (en) 2004-09-23 2015-01-13 Intrapace, Inc. Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060173508A1 (en) * 2003-05-16 2006-08-03 Stone Robert T Method and system for treatment of eating disorders by means of neuro-electrical coded signals

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8239027B2 (en) 2001-05-01 2012-08-07 Intrapace, Inc. Responsive gastric stimulator
US8364269B2 (en) 2001-05-01 2013-01-29 Intrapace, Inc. Responsive gastric stimulator
US9517152B2 (en) 2001-05-01 2016-12-13 Intrapace, Inc. Responsive gastric stimulator
US8934976B2 (en) 2004-09-23 2015-01-13 Intrapace, Inc. Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors
US9259342B2 (en) 2004-09-23 2016-02-16 Intrapace, Inc. Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors
US9662240B2 (en) 2004-09-23 2017-05-30 Intrapace, Inc. Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors
US8214049B2 (en) 2007-07-25 2012-07-03 Intrapace Inc. Gastric stimulation systems and methods utilizing a transgastric probe
EP2318089A4 (fr) * 2008-07-11 2011-08-10 Gep Technology Inc Appareil et procédés minimalement invasifs pour un traitement de l'obésité
US8868215B2 (en) 2008-07-11 2014-10-21 Gep Technology, Inc. Apparatus and methods for minimally invasive obesity treatment
US8715181B2 (en) 2009-04-03 2014-05-06 Intrapace, Inc. Feedback systems and methods for communicating diagnostic and/or treatment signals to enhance obesity treatments

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