Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present patent application is a divisional of the patent application identified by U.S. Ser. No. 11/893,786, filed on Aug. 17, 2007, the entire content of which is hereby incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not applicable. 
       REFERENCE TO A “SEQUENCE LISTING”, A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISC AND AN INCORPORATION BY REFERENCE OF THE MATERIAL ON THE COMPACT DISC 
       [0004]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0005]    Electrical stimulation, or pacing, was advocated as a possible treatment for gastric motor dysfunction as early as 1963. Experimentation in the late 1960s and early 1970s, began to demonstrate the significance of gastrointestinal myoelectrical activity and its relation to contractile activity. 
         [0006]    Electrical stimulation has been shown to be able to alter, inhibit, or excite gastrointestinal motor functions, activate intrinsic and extrinsic neuronal pathways and/or solicit hormonal/peptide releases. Because of these characteristics, electrical stimulation has been shown to be effective in normalizing gastric dysrhythmia, accelerating gastric emptying, and reducing symptoms such as nausea and vomiting. Recently, electrical stimulation has also been studied as a therapy for obesity. 
         [0007]    Obesity is a growing public health problem with a lack of satisfactory treatments. Recent research seems to suggest that electrical stimulation may delay gastric emptying and thereby assist in prolonging meal intervals and reducing frequent snacking without the risks and complications of surgery. Fluid intake may also be induced by electrical stimulation so as to assist in reducing appetite, for example, by reducing the capacity for accommodating food within the gastrointestinal tract as detailed in “Therapeutic Potential of Duodenal Electrical Stimulation for Obesity: Acute Effects on Gastric Emptying and Water Intake” by Shi Liu, Xiaohua Hou, and J. D. Z. Chen in  American Journal of Gastroenterology , Volume 100, pages 792-796 (2005) that is hereby incorporated by reference in its entirety. 
         [0008]    Most of the devices developed to provide for electrical stimulation are located within the gastric region of the gastrointestinal tract. See GASTROINTESTINAL PACEMAKER HAVING PHASED MULTIPOINT STIMULATION (U.S. Pat. No. 5,690,691), GASTROINTESTINAL ELECTRICAL STIMULATION (U.S. Pat. No. 6,826,428), SENSOR BASED GASTROINTESTINAL ELECTRICAL STIMULATION FOR THE TREATMENT OF OBESITY OR MOTILITY DISORDERS (U.S. Patent Publication No. 2005/0222638), PROCESS FOR ELECTROSTIMULATION TREATMENT OF MORBID OBESITY (U.S. Patent Publication No. 2004/0088022), TACHYGASTRIAL ELECTRICAL STIMULATION (U.S. Patent Publication No. 2005/0222637), each of which is hereby incorporated by reference in its entirety. 
         [0009]    The enteric nervous system (ENS) contains numerous short axon and inter-neurons in the intestinal wall. The vast number of neurons and neuronal connections in the intestinal ENS carry out many digestive reflexes independent from the central nervous system. For example, the complex movements of peristalsis seen in the esophagus, stomach, and intestine are entirely initiated and regulated by the ENS. In addition, many neurotransmitters are released by ENS neurons to control glandular secretion and muscle contraction in the gut wall. Research has shown that stimulation in one area of the intestinal tract can provide stimulation in a whole other area within the ENS system. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    In one embodiment, the present invention is related to a method of using a stimulation device to emit a medium in the appendicular region for treatment of a gastrointestinal disorder. In general, a stimulation device is inserted into the luminal cavity of the appendix and delivers the medium for treatment of the gastrointestinal disorder or eating disorder. The stimulation device may be placed endoscopically and/or surgically inserted into the appendix. For example, the stimulation device may be inserted into the cavity of the appendix using endoscopic techniques by placing the stimulation device in a pouch underneath the skin. 
         [0011]    In one version, the stimulation device comprises at least two electrodes sized and shaped for insertion into the mucosa or submucosa of the appendix. The electrodes are in communication with a pulse generator located in the luminal cavity of the appendix. In another version, a pair of stimulation electrodes are inserted into the seromuscular layer of the appendix and connected to a generator inserted subcutaneously within the abdominal region. 
         [0012]    In general, the pulse generator delivers pulses to the electrodes located in the mucosa and/or submucosa or serosa of the appendix such that the electrodes provide stimulation to the appendicular wall and thus the gastrointestinal tract through the enteric nervous system of the user. The pulses can be provided in a variety of different manners, such as intermittent pulses, continuous pulses, and/or a train of intermittent and/or continuous pulses. Such pulses can be delivered via the pulse generator to the electrodes via any suitable medium, such as electricity, acoustic waves, radiation, photons, or the like. 
         [0013]    The method provides treatment for several gastrointestinal diseases and disorders. For example, the method may be used in the treatment of dyspepsia, postoperative ileus, irritable bowel syndrome, constipation, diarrhea, fecal incontinence, pain and discomfort associated with visceral organs, obstructed intestines, eating disorders including obesity, nausea and/or emesis, including chemotherapy-induced emesis. 
         [0014]    In one version, the method further includes the step of programming a controller in communication with the pulse generator with a stimulation parameter. The controller is located either external and/or internal to the body. The controller can communicate with the pulse generator via any suitable manner such as leads, electromagnetic waves, inductive coupling, or the like. In one preferred embodiment, the controller electromagnetically controls the pulse generator. 
         [0015]    Preferably, the controller is programmed with a stimulation parameter either prior to or subsequent to insertion of the stimulation device in the appendix. The stimulation parameter is utilized by the controller to control the stimulation device such that the stimulation device delivers predetermined types of pulses to the submucosa of the appendix. Stimulation parameters can include frequency, pulse width, amplitude, and the like. It should be understood that the stimulation parameters utilized to control the controller can be modified according to the desires of the designer and/or the user. 
         [0016]    In one version, the stimulation device is further provided with a sensor system for detecting environmental conditions around the stimulation device or any part of the gastrointestinal tract. The environmental conditions can be used to determine parameters regarding the external environment of the stimulation device when inserted in the appendix. Information received from the sensor system can provide feedback to help control the stimulation device. The sensor system can include one or more sensors for sensing a variety of different types of environmental factors which may be surrounding the stimulation device or the gastrointestinal tract such as, for example, mechanical contractions, pressure, tension, electrical signals, temperature, pH or the like. 
         [0017]    In another version, the stimulation device is further provided with a power source for supplying power to the stimulation device. The power source can be implemented in a variety of manners, such as a battery supported by the stimulation device, or a separate device provided external to the user which provides power to the stimulation device through a wireless mechanism, such as inductive loop coupling. 
         [0018]    In another aspect, the present invention is directed to a method of using a stimulation device to emit a medium to the rectum for treatment of a gastrointestinal disorder and/or eating disorder. In general, the stimulation device is inserted into the internal wall of the rectum. The medium is delivered, via the stimulation device, to the rectum for the treatment of the gastrointestinal disorder and/or eating disorder. 
         [0019]    In another aspect, the present invention is directed to a stimulator device for emitting a medium to the gastrointestinal tract of a user. In general, the stimulator device is comprised of at least two electrodes sized and shaped for insertion into the mucosa, submucosa or serosa of the appendix of the user. The electrodes supply the medium to the appendix. Additionally, a pulse generator, for delivering pulses of the medium to the electrodes, is placed subcutaneously in the user. Additionally, a controller, in communication with the pulse generator, controls the pulses. Preferably, the electrodes, pulse generator, and controller are supported by a housing. 
         [0020]    In another aspect, the present invention is directed to a delivery system for providing a stimulator device to the appendix. In general, the delivery system includes an elongated tubular member having a distal end adapted for insertion into an anal orifice. A stimulator device is supported by the elongated tubular member and deployed in the appendicular area. The stimulator device includes a housing constructed of a bio-compatible non-digestible material; a pulse generator disposed in the housing for generating pulses; a controller disposed in communication with the pulse generator for controlling the pulses; and, at least two electrodes supplying a medium containing the pulses generated by the pulse generator to the gastrointestinal tract. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0021]    So that the above recited features and advantages of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to the embodiments thereof that are illustrated in the appended drawings. It is to be noted however that the appended drawings illustrate only typical embodiments of the invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments. 
           [0022]      FIG. 1A  is a diagrammatic view of lower digestive system including the appendicular region and rectal region. 
           [0023]      FIG. 1B  is a schematic block diagram view of one embodiment of a stimulator device positioned in the appendicular region in accordance with the present invention. 
           [0024]      FIG. 1C  is a diagrammatic view of another embodiment of a stimulator device positioned in the appendicular region in accordance with the present invention. 
           [0025]      FIG. 1D  is a diagrammatic view of another embodiment of a stimulator device positioned in the rectal region in accordance with the present invention. 
           [0026]      FIG. 1E  is a diagrammatic view of another embodiment of a stimulator device positioned in the rectal region in accordance with the present invention. 
           [0027]      FIG. 2  is a diagrammatic view of the embodiment of the stimulator device illustrated in  FIG. 1C  and  FIG. 1D  constructed in accordance with the present invention. 
           [0028]      FIG. 3  is a schematic, block diagram of another embodiment of a stimulator device constructed in accordance with the present invention. 
           [0029]      FIGS. 4   a - 4   e  illustrate a variety of exemplary pulses which can be generated by a stimulator devices for treating a variety of types of gastrointestinal disorders. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0030]    Present embodiments of the invention are shown in the above-identified figures and described in detail below. In describing the embodiments, like or identical reference numerals are used to identify common or similar elements. The figures are not necessarily to scale and certain features in certain views of the figures may be shown exaggerated in scale or in schematic in the interest of clarity and conciseness. Please add/modify explanations of figures based on my addition and changes to the figures. 
         [0031]    Referring now to the drawings, and in particular to  FIGS. 1A-1E , shown therein and designated by reference numeral  10  is a stimulator device (hereinafter referred to as “stimulator device”), constructed in accordance with the present invention, for providing stimulation to a gastrointestinal tract  12  of a user  14 . The gastrointestinal tract  12  of the user  14  includes the alimentary canal and organs associated with the alimentary canal such as the stomach, small intestine, large intestine, and the like. Users  14  may include humans, mammals, or other multicellular organism having a gastrointestinal tract  12 . 
         [0032]    In general, the stimulator device  10  is placed in the appendix or within an appendicular region  16  and/or rectal region  18  of a lower digestive tract  17  of the user  14 . The vermiform appendix is located at the junction of the small intestine and the large intestine. The appendix is generally credited with no significant function and is most commonly explained as a vestigial structure within the body. It is routinely removed without any ill effects or side effects. However, the linkage of the appendix within the ENS to the gastrointestinal tract  12  provides an avenue for electrical stimulation in the treatment of gastrointestinal disorders giving a desirable use and purpose for this vestigial structure. 
         [0033]    The rectum is also linked within the ENS to the gastrointestinal tract  12  and offers another option for convenient placement of the stimulator device  10 . Specifically, the relative proximity of the anal orifice to the rectum allows placement of the stimulator device  10  in the rectum without the need for extensive surgical procedures currently practiced in gastrointestinal stimulator placement. 
         [0034]    Preferably, at least a portion of the stimulator device  10  is placed in contact with the appendicular wall  20  and/or rectal wall  22  of the user  14 . The stimulator device  10  may contact the external appendicular wall  20  and/or rectal wall  22 , the interior appendicular wall  20  and/or rectal wall  22 , and/or be within the appendicular wall  20  and/or rectal wall  22 . For example, the stimulator device may be placed in contact with the mucosal surface, underlying vascular submucosa, serosa, and/or layered muscularis externa of the appendicular wall  20  and/or rectal wall  22 . Preferably, the stimulator device  10  is inserted into the submucosa of the appendicular wall  20  and/or rectal wall  22 . 
         [0035]    Optionally, the stimulator device  10  may be attached to the appendicular wall  20  and/or rectal wall  22  to prevent migration of the stimulator device  10  through the gastrointestinal tract  12 . The stimulator device  10  may be attached to the appendicular wall  20  and/or rectal wall  22  through the use of projections, barbs, umbrella connectors, sutures, adhesives, and/or the like. Additionally, multiple stimulator devices  10  may be placed within the user  14 . For example, the user  14  may have a first stimulator device  10  within the appendicular region  16  and a second stimulator device  10  within the rectal region  18  of the user  14 . 
         [0036]    Once positioned in contact with the appendicular wall  20  and/or rectal wall  22 , the stimulator device  10  delivers pulses of a medium and provides stimulation to the gastrointestinal tract  12  through the enteric nervous system. Placement of the stimulator device  10  within one area of the enteric nervous system provides stimulation not only at the area of contact, but also provides stimulation within other areas of the ENS system. For example, placement of the stimulator device  10  within the appendicular region  16  can provide stimulation initiating peristaltic activity within the gastrointestinal tract  12 . 
         [0037]    Stimulation of the gastrointestinal tract  12  through the enteric system will alter, inhibit, or excite gastrointestinal motor functions, activate intrinsic and extrinsic neuronal pathways and/or solicit hormonal/peptide releases. The effects of stimulation on these functions/pathways are related to the selection of stimulation parameters which are discussed in greater detail below and have therapeutic potentials for various diseases/disorders. The stimulator device  10  can thus be used for treating a variety of digestive and eating disorders as well as in use in treating chemotherapy-induced emesis. Exemplary eating disorders include obesity, binging, bulimia, and the like. Gastrointestinal disorders include dysphagia, gastroesophageal reflux diseases, functional dyspepsia, gastroparesis, postoperative ileus, irritable bowel syndrome, constipation, diarrhea, fecal incontinence, pain/discomfort, nausea and vomiting, and the like. 
         [0038]    The stimulator device  10  can be programmed with stimulation parameters prior to placement of the stimulator device  10  within the appendicular region  16  and/or rectal region  18  of the user  14  so that a particular disease or disorder will be treated. A health care provider or user may be presented with a variety of stimulator devices  10  with each stimulator device  10  pre-programmed to treat a different disorder. Alternatively, the stimulator device  10  can be programmed to treat a particular disorder immediately prior to administration. Alternatively, the stimulator device  10  can be programmed with a variety of different types of treatment regimens for different diseases and/or disorders so that the stimuli can be changed during treatment of the gastrointestinal disorder without need for the removal of the stimulator device  10 . 
         [0039]    As illustrated in  FIGS. 1B and 1E , the stimulator device  10  includes at least two electrodes  26  and  28  in communication with a pulse generator  30 . The electrodes  26  and  28  can be provided as one or multiple pairs and in varying shapes. For example, the electrodes  26  and/or  28  can be provided as a point electrode, a ring electrode, or a patch electrode. 
         [0040]    The electrodes  26  and  28  may be surgically implanted or insertably placed within the appendicular region  16  and/or rectal region  18 . For example, for the placement of stimulator into the appendix or rectum, colonoscopy or endoscopy can be utilized. For the placement of stimulator in other areas, various surgical techniques may be used depending on the location of placement. For example, both traditional surgical techniques and/or laparoscopic techniques may be used in placing the stimulator device  10  in the appendicular region  16  and/or rectal region  18 . Preferably, laproscopic techniques, using small incisions in comparison to large incisions of traditional surgery, are used to place the stimulator device  10 . Additionally, other forms of surgical placement, known now or developed within the future, may be used as long as the stimulation device is placed in contact with the appendicular wall  20  and/or rectal wall  22  of the user  14 . 
         [0041]    The electrodes  26  and  28  are in communication with the pulse generator  30  such that pulses can be provided from the pulse generator  30  to the electrodes  26  and  28 . The pulse generator delivers a frequency of pulses to the electrodes  26  and  28  providing emission of the medium to the appendicular wall  20  and/or rectal wall  22 . For example, the pulse generator  30  delivers pulses to the electrodes  26  and  28  in contact with the appendicular wall  20  such that the electrodes  26  and  28  provide stimulation to the gastrointestinal tract  12  of the user  14  through the enteric nervous system. 
         [0042]    The pulses provided by the pulse generator  30  to the electrodes  26  and  28  can be provided in a variety of different manners, such as intermittent pulses, continuous pulses, and/or a train of intermittent and/or continuous pulses. Selection of the pulses is determined based on the particular gastrointestinal disease(s) and/or disorder(s) being treated as described in more detail below. 
         [0043]    Such pulses can be delivered via the pulse generator  30  to the electrodes  26  and  28  via any suitable medium, such as electricity, acoustic waves, radiation, photons, or the like. Preferably, the medium is in the form of electrical stimulation to the appendicular wall  20  and/or rectal wall  22 . 
         [0044]    The pulse generator  30  adjacent to the electrodes  26  and  28  or separate from the electrodes  26  and  28 . In one embodiment, the pulse generator  30  is separate from the electrodes  26  and  28  and inserted subcutaneously within the abdominal region. Preferably, the pulse generator  30  is inserted subcutaneously within the abdominal region above the belt line of the user  14 . In another embodiment, as illustrated in  FIGS. 1C and 1D , the pulse generator  30  is adjacent to the electrodes  26  and  28 . 
         [0045]    Additionally, pulse generator  10  may utilize an internal power source or an external power source. It is contemplated that the power source may be located external to the user  14 , provided the power source is in communication with the pulse generator  30 . For example, the power source may be provided external to the user  14  through a wireless mechanism, such as inductive loop coupling, electromagnetic control, or the like. 
         [0046]    The stimulator device may optionally include a controller  32 . The controller  32  communicates with the pulse generator  30  for controlling the pulses generated by the pulse generator  30 . The controller  32  can be analog, digital, or a combination of both. The controller  32  may be a computer, a microcontroller, a microprocessor, or the like. 
         [0047]    The controller  32  uses stimulation parameters to regulate the pulse generator  30  and provide a variety of different types of treatment regimens for different diseases and/or disorders. Stimulation parameters, as discussed in more detail below, may include frequency, pulse width, amplitude, and the like. Programming of the controller  32  can regulate pulses generated by the pulse generator  30  so that can the pulses change based upon the treatment regime for the user  14 . The controller  32  may be programmed with stimulation parameters prior to insertion and/or placement of the stimulator device  10  and/or after insertion and/or placement of the stimulator device  10 . 
         [0048]    Shown in  FIG. 2  is a diagrammatic view of one example of the stimulator device illustrated in  FIG. 1C  and  FIG. 1D  constructed in accordance with the present invention. The stimulator device  10  is provided with two electrodes  26  and  28 , the pulse generator  30 , and the controller  32 . Additionally, the stimulator device includes a housing  34  and a power source  36 . 
         [0049]    The housing  34  is constructed of a biocompatible, non-digestible material for use within the appendicular region  16  and/or the rectal region  18  of the user  14 . Examples of biocompatible, non-digestible materials suitable for use in forming the housing  34  are, but not limited to, biocompatible metals, such as unalloyed titanium, wrought titanium alloy, nitrogen austenitic steel, stainless steel, and biocompatible plastic such as polyvinylchloride, polytetrafluoroethelyne, polyethersulfone, polyurethane, polycarbonate, polyetheretherketone and polypropylene. 
         [0050]    The housing  34  is sized and shaped for placement within the appendicular region  16  and/or rectal region  18 . Preferably, the housing is sized and shaped for transport through the anal orifice. For example, the housing  34  can be shaped in the form of a capsule. However, it should be understood that the housing  34  can be provided in other shapes and/or sizes, so long as the housing  34  can be inserted through the anal orifice and/or placed in at least a portion of the appendicular region  16  and/or rectal region  18  preferably without causing any negative side effects, such as irritation. It is also desirable for the housing  34  to be sized and shaped so as not to block the appendicular region  16  and/or rectal region  18  leading to interference with the operation of the gastrointestinal tract  12 . Further, it should be understood that rather than simply being constructed of a biocompatible, non-digestible material, the housing  34  can be formed of a non-biocompatible, or even digestible material that is coated with a biocompatible non-digestible material. 
         [0051]    The housing  34  is formed with the electrodes  26  and  28  separated by an insulating material  38 . The electrodes  26  and  28  are connected to the insulating material  38  so as to form a sealed container. The housing  34  defines an interior space containing the pulse generator  30 , the controller  32 , and the power source  36 . However, it should be understood that at least the power source  36 , and the controller  32  can be external to the housing  34  so long as the power source  36  and/or controller  32  can communicate and/or provide power, and/or control to the pulse generator  30 . 
         [0052]    As discussed above, the controller  32  communicates with the pulse generator  30  for controlling the pulses generated by the pulse generator  30 . The electrodes  26  and  28  supply a medium containing the pulses generated by the pulse generator  30  to the appendicular wall  20  and/or rectal wall  22 . As discussed above, the medium can be provided in a variety of forms such as electricity, acoustic waves, radiation, photons, or the like. 
         [0053]    The electrodes  26  and  28  can be provided as one or multiple pairs and can be provided on the housing  34  in various locations and different shapes. For example, the electrodes  26  and/or  28  can be provided as a point electrode, a ring electrode, or a patch electrode. The distance between the electrodes  26  and  28  in a pair can also vary. 
         [0054]    As shown in  FIG. 2 , the controller  32  is supported by the housing  34  and is contained within the interior space of the housing  34 . The controller  32  can be external to the housing  34  or at least portions of the controller  32  can be external to the housing  34  so long as the controller  32  can communicate with and/or control the pulse generator  30 . 
         [0055]    The power source  36  is also supported by the housing  34 . Preferably, the power source  36  is within the internal space of the housing  34 . However, it is contemplated that the power source  36  may be located external to the housing  34 , provided the power source  36  is in communication with the pulse generator  30  and/or the controller  32 . For example, the power source  36  may be provided external to the user  14  through a wireless mechanism, such as inductive loop coupling, electromagnetic control, or the like. 
         [0056]    The housing  34  may optionally include means for attaching the stimulator device  10  to the appendicular wall  20  and/or rectal wall  22 . As previously discussed, attachment means include, but are not limited to, projections, barbs, umbrella connectors, sutures, adhesives, and/or the like. 
         [0057]    Referring to  FIG. 3 , regulation of the pulse generator  30  by the controller  32  may include an open-loop system  40 , a closed loop system  42 , or a combination of the like. In the open loop system  40 , pulses are delivered to the electrodes  26  and  28  without the use of sensing inputs such as a sensor system  44 . In the closed loop system  42 , pulses are delivered to the electrodes  26  and  28  based on inputs to the controller  32  via the sensor system  44 . For example, the sensor system  44  can deliver electrical signals to the controller  32  that vary or are indicative of the following conditions: mechanical contractions, pressure, tension, electrical signals, temperature, pH or the like. Although  FIG. 3  shows the controller  32 , it should be noted the stimulator device  10  may include the pulse generator  30  supplying pulses to the electrodes  26  and  28  without the use of the controller  32 . 
         [0058]    One embodiment of the open loop system  40  includes the controller  32 , the pulse generator  30 , and the electrodes  26  and  28 . The controller  32  is in communication with the pulse generator  30  and regulates pulses generated by the pulse generator  30 . The pulse generator  30  provides the pulses to the electrodes  26  and  28 . The controller  32  may optionally contain a timing mechanism, such as an internal clock, for further controlling the pulses. In another embodiment (not illustrated), the controller  32  is in direct communication with the electrodes  26  and  28  directly and alters the pulses supplied to the electrodes  26  and  28  directly. 
         [0059]    The closed-loop system  42 , as illustrated in  FIG. 3 , includes the controller  32 , the pulse generator  30 , the electrodes  26  and  28 , and the sensor system  44 . The sensor system  44  communicates with the controller  32  and detects environmental conditions external to the stimulator device  10 . The environmental conditions can be used to determine the location of the stimulator device  10  within the gastrointestinal tract  12  of the user  14  if the stimulator device  10  migrates. Additionally the environmental conditions can be used to vary the frequency and/or intensity of the pulses generated by the pulse generator  30  as needed. The sensor system  44  can include one or more sensors for sensing a variety of different types of environmental factors which may be surrounding the stimulator device  10 . For example, mechanical contractions, pressure, tension, electrical signals, temperature, pH or the like. 
         [0060]    The information received from the sensor system  44  is fed back to the controller  32  so that the controller  32  can vary stimulation parameters and regulate pulses generated by the pulse generator  30 . For example, the sensor system  44  can detect the effect of stimulation to the appendicular region  16  and/or rectal region  18 . The location or effect of the stimulator device  12  within the user  14  is fed back to the controller  32 . The controller  32  then regulates the frequency, duration, and/or amplitude of the pulses generated by the pulse generator  30  based on the effect of the stimulator device  10  within the appendicular region  16  and/or rectal region  18  of the user  14 . 
         [0061]    The sensor system  44  can also provide a method for synchronized stimulation such that pulses can be provided to the appendicular region  16  and/or rectal region  18  of the user  14  upon detection by the sensor system  44  of a mechanical contraction within the user  14 . Synchronizing each pulse with the intrinsic physiological activity of the user  14  may enhance gastrointestinal contractions and accelerate transport of nutrients along the gastrointestinal tract. 
         [0062]    As illustrated in  FIG. 3 , the stimulator device  10  may optionally include a telemetry system  46  that assists in providing external control, external programming, and/or permitting measurement and reporting of information regarding the stimulator device  10  and/or the environmental conditions surrounding the stimulator device  10 . The telemetry system provides communication between an internal controller, located within the user  14  such as the sensor system  44  and/or controller  32 , while an external controller  48  is external to user. The external controller  48  can be either proximally located to the user  14  or located at a distance to the user  14  so long as the telemetry system can provide communication between the internal controller, such as the sensor system  44  and/or controller  32 , and the external controller  48 . The communication can be through radio frequency, infrared light, laser light, visible light, acoustic energy, or the like. Both the internal controller, such as the sensor system  44  and/or controller  32 , and external controller  48  are preprogrammed to provide monitoring, alerting, transmitting, and/or record-keeping of information generated and/or needed for the stimulator device  10 . 
         [0063]    In one embodiment, communication between the sensor system  44 , as the internal controller, and a microprocessor, as the external controller  48 , provides monitoring of environmental information surrounding the stimulator device  10  and provides an alerting function if the microprocessor and/or sensor system  44  detect abnormal conditions within the appendicular region  16  and/or rectal region  18  of the user  14 . In another embodiment, communication between the sensor system  44 , as the internal controller, and the microprocessor, as the external controller  48 , allows for the analysis of the environmental information using a decision-making algorithm to provide stimulation parameters. The environmental information is provided by the sensor system  44  and communicated by the telemetry system  46  to the microprocessor. The microprocessor uses the algorithm to determine the stimulation parameters. Such stimulation parameters are communicated again through the telemetry system  46  to either the controller  32  and/or sensor system  44  to regulate the pulses generated by the pulse generator  30 . 
         [0064]    As previously discussed, stimulation parameters are utilized by the controller  32  to control the pulse generator  30 . Stimulation parameters can include frequency, pulse width, amplitude, and the like. The pulses may be intermittent pulses, continuous pulses, and/or trains of intermittent and/or continuous pulses. The controller  32  can vary the stimulation parameters to provide variations in the pulses such that the pulse generator  32  provides long-pulse, short-pulse, dual phase pulses, trains of short-pulses, biphasic trains of pulses, or other variation of pulses.  FIGS. 4   a - e  graphically illustrates the relative duration and amplitude of a variety of the exemplary pulses which can be generated by a pulse generator  30  based on the various stimulation parameters provided by the controller  32 . It should be understood that the stimulation parameters utilized by the controller  32  can be modified according to the desires of the designer and/or the patient. 
         [0065]      FIG. 4   a  graphically illustrates repetitive long-pulses having a pulse width in the order of milliseconds. The long pulse method is able to ‘pace’ or entrain natural slow waves of the digestive tract. In this method, the electrical stimulus is composed of repetitive single pulses with a pulse width in the order of milliseconds and a stimulation frequency in the vicinity of the physiological frequency of the gastric slow wave as detailed in the article “Systematic review: applications and future of gastric electrical stimulation” by J. Zhang and J. D. Z. Chen in  Alimentary Pharmacology  &amp;  Therapeutics , Volume 24, pages 991-1002 (2006) that is hereby incorporated by reference in its entirety. 
         [0066]      FIG. 4   b  graphically illustrates repetitive short pulses having a pulse width that is substantially shorter than the long pulse of  FIG. 4   a  and is in the order of a few hundred microseconds as opposed to milliseconds. The stimulation frequency is usually a few times higher or substantially higher than the physiological frequency of the gastric slow wave. 
         [0067]      FIG. 4   c  graphically illustrates the combining of short pulses and long pulses into a dual phase pulsing. This repetitive pulsing method is composed of one short pulse, or a multitude of short pulses, in the order of a few hundred microseconds, followed by a long pulse, in the order of a few hundred millisecond. Dual phase pulsing has been shown to provide normalizing of gastric dysrhythmia and improvement in the symptoms such as nausea and vomiting. Alternatively, dual phase pulsing may include a long pulse followed by a short pulse, or other combinations of long and short pulses. 
         [0068]      FIG. 4   d  graphically illustrates repetitive trains of pulses derived from the combination of two signals. The first signal is a continuous short pulse with a high frequency. The second signal is a control signal to turn the pulses on and off. For example, the second signal can contain a stimulation parameter providing that the duration of the pulse is ‘on’ for x seconds and ‘off’ for y seconds. The addition of x and y can then determine the frequency of the pulse train. This kind of stimulation is frequently used in nerve stimulation and other related areas. It should be understood that trains of pulses can include trains of short-pulses, trains of long-pulses, and/or a combination of the both long and short pulses. 
         [0069]      FIG. 4   e  graphically illustrates biphasic trains of pulses in which pulse pairs are repeatedly symmetrically generated. The first pulse of each pair has a positive amplitude and the second pulse of each pair has a negative amplitude. Similar to  FIG. 4   d , pulses are repeatedly generated from the combination of two signals. The first signal includes continuous pulse pairs that are repeatedly symmetrically generated. The second signal is a control signal to turn the pulses on and off. For example, the second signal can contain a stimulation parameter providing that the duration of the pulse is ‘on’ for x seconds and ‘off’ for y seconds. The addition of x and y can then determine the frequency of the pulse train. 
         [0070]    It is contemplated, that in certain applications, it may be beneficial to vary the pulses during treatment of the gastrointestinal disorder or in the treatment of multiple disorders. For example, short pulses may be used if the device is used for treating disorders associated with the nervous systems such as pain, nausea and vomiting, long pulses or train of pulses may be used if the device is used for treating disorders associated with the movement of nutrient through the gastrointestinal tract, such as obesity or impaired gastrointestinal motility; a combination of short and long pulses will be used if the device is used to treat disorders affected by both the nervous systems and gastrointestinal motility. Additionally, although a particular pulse may be used by stimulator device  10 , it may be beneficial to vary the amplitude, frequency, and/or duration of the pulse depending on location of the stimulator device  10 . 
         [0071]    As discussed above, the stimulator device  10  is used to emit a medium for treatment of eating disorders such as obesity or a gastrointestinal disorder or disease, such as dysphagia, gastroesophageal reflux diseases, functional dyspepsia, gastroparesis, postoperative ileus, irritable bowel syndrome, constipation, diarrhea, fecal incontinence, pain/discomfort, nausea and vomiting, obesity, eating disorders as well as in the treatment of chemotherapy-induced emesis. 
         [0072]    In general, use of the stimulator device  10  includes providing the stimulator device  10  to the user  14 . The stimulator device  10  is placed in the gastrointestinal tract  12  of the user  14 . Methods of administering the stimulator device  10  include placement of the stimulator device within the appendicular region  16  and/or rectal region  18  of the user  14  such as through traditional surgical procedures, laparoscopic procedures, and the like. 
         [0073]    Additionally, methods of administering the stimulator device  10  may include non-surgical methods such as insertion of the stimulator device  10  into the anal orifice of the user through the use of a delivery catheter. The delivery catheter includes an elongated tubular member having at least one end adapted for insertion into the anal orifice. The stimulator device  10  is supported by the elongated tubular member for deployment within the appendicular region  16  and/or rectal region  18 . 
         [0074]    Once the stimulator device  10  is in contact with the appendicular wall  20  and/or rectal wall  22 , the stimulator device  10  delivers pulses of the medium for treatment of gastrointestinal diseases and/or disorders. Such pulses can be intermittent pulses, continuous pulses, and/or trains of intermittent and/or continuous pulses as discussed previously. 
         [0075]    It is contemplated that the stimulator device  10  may be distributed in a variety of methods. One method of distribution may include providing the stimulator device  10  to the user  14  by a medical professional. For example, a pharmaceutical distributor can distribute the stimulator device  10  to a medical professional for use in treating gastrointestinal disorders, diseases, and/or for use in chemotherapy-induced emesis. Alternatively, the stimulator device  10  can be distributed to a pharmacy and/or provided to a retailer for over-the-counter distribution to a user  14  for use in treating gastrointestinal disorders, diseases and/or for use in chemotherapy-induced emesis as well as obesity. The pharmacy and/or retailer may then sell the stimulator device  10  directly to the user  14 . Additionally, the stimulator device  10  may be provided in a kit containing the delivery catheter. 
         [0076]    The foregoing disclosure includes the best mode for practicing the invention. It is apparent, however, that those skilled in the relevant art will recognize variations of the invention that are not described herein. While the invention is defined by the appended claims, the invention is not limited to the literal meaning of the claims, but also includes these variations.

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