Abstract:
This invention provides a method and system for the curative treatment of obesity. A first aspect of this invention is that it enables identification of the nerves responsible for the relaxation of the stomach muscles that occurs prior to and during eating. A second aspect of the invention is that it allows the physician to identify focal nerve sites in the stomach and upper duodenum that are associated with producing sensations of hunger and satiety. Nervous transmission from these sites can be modulated or blocked all together so as to minimize the sensation of hunger. A third aspect of this invention is that allows a physician to shrink selected portions of the innermost oblique muscle and middle circular muscle layers of the stomach. This can be performed in a physician&#39;s office using local anesthesia. Shrinkage of these muscles produces a feeling of satiety that enhances the patient&#39;s efforts to restrict his caloric intake.

Description:
RELATED APPLICATIONS  
       [0001]     This application is a continuation of co-pending U.S. application Ser. No. 09/571,080, filed May 15, 2000, which claims the benefit of provisional U.S. Application Ser. No. 60/134,672, filed May 18, 1999. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to controlling obesity.  
       BACKGROUND OF THE INVENTION  
       [0003]     Obesity is directly associated with disorders such as osteoarthritis (especially in the hips) sciatica, varicose veins, thromboembolism, ventral and hiatal hernias, hypertension, insulin resistance and hyperinsulinemia. All of these conditions can be ameliorated by treatment of obesity, provided the weight loss is significant and enduring.  
         [0004]     The known art of treating obesity includes behavioral strategies, various different pharmaceutical interventions and surgery.  
         [0005]     One problem in the known art of behavioral strategies is patient compliance. Extremely high levels of patient compliance over a long period of time are required to produce a significant weight loss.  
         [0006]     Problems in the known art of pharmaceutical intervention include drug dependence and side effects. Treatment with amphetamine analogs requires habitual use of an addictive drug to produce a significant weight loss. Treatment with drugs such dexfenfluramine and fenfluramine is frequently associated with primary pulmonary hypertension and cardiac valve abnormalities. Drugs such as sibutramine cause a substantial increase in blood pressure in a large number of patients.  
         [0007]     The known art of surgical treatment of obesity includes operative procedures such as end-to-end anastomosis of about 38 cm of proximal jejunum to 10 cm of terminal ileum and other variants of jejunoileal manipulation. While such procedures are extremely effective, the overall rates of surgical mortality and associated hepatic dysfunction are so high that this treatment is only indicated for younger patients who are morbidly obese.  
         [0008]     Accordingly, it would be advantageous to provide a method and system for treatment of obesity that produces reasonably rapid weight loss, long term results, low surgical mortality, few side effects and can be performed under local anesthesia. This advantage is achieved is an embodiment of an invention in which a balloon bearing an array of electrodes is deployed in the stomach and upper duodenum. This device maps and ablates nerves in these tissues and causes shrinkage of stomach muscle by creating a pattern of thermal lesions. Weight control is achieved by creating a sense of satiety in the patient. This can be achieved by direct modulation of nerves responsible for the sensation of hunger or by inhibiting the let-down reflex of the stomach muscles that serves as a precursor to digestion.  
       SUMMARY OF THE INVENTION  
       [0009]     This invention provides a method and system for the curative treatment of obesity.  
         [0010]     A first aspect of this invention is that it enables identification of the nerves responsible for the relaxation of the stomach muscles that occurs prior to and during eating. Relaxation and extension of these muscles allows the stomach to take in a greater quantity of food and facilitates the feeding process. In the event that impulses from the gastric cardia fail to transmit information to the vagus nerve and hindbrain, the muscular tone of the stomach will remain normal during a meal. The result is early satiety and correspondingly, less food intake. In a preferred embodiment, this invention can be used to modulate these nerves in the gastric cardia and inhibit the relaxation of stomach muscles, thereby creating a sensation of fullness more rapidly than would occur otherwise.  
         [0011]     A second aspect of the invention is that it allows the physician to identify focal nerve sites in the stomach and upper duodenum that are associated with producing sensations of hunger and satiety. Nervous transmission from these sites can be modulated or blocked all together so as to minimize the sensation of hunger.  
         [0012]     A third aspect of this invention is that it allows a physician to shrink selected portions of the innermost oblique muscle and middle circular muscle layers of the stomach. This can be performed in a physician&#39;s office using local anesthesia. Shrinkage of these muscles produces a feeling of satiety that enhances the patient&#39;s efforts to restrict his caloric intake.  
         [0013]     One method provides for delivering energy to ablate tissue in a least one of the stomach, duodenum, and gastric cardia. Ablating tissue creates a thermal lesion that causes shrinkage of stomach muscle. In one embodiment, the method further comprises, prior to delivering energy, identifying nerves responsible for relaxation of stomach muscles. Delivering energy can serve to modulate nerves in the gastric cardia to inhibit the relaxation of stomach muscles. In one embodiment, energy is delivered to portions of the duodenum that are generally proximate to the stomach. In one embodiment, the energy delivered is radio frequency energy.  
         [0014]     An apparatus for treatment of obesity comprises a catheter capable of being disposed proximate to a junction between the stomach and the duodenum of a patient, a first balloon, a second balloon, a plurality of electrodes embedded in the outer surfaces of said first balloon and said second balloon, and a plurality of lumens. The catheter can be disposed in the gastric cardia, greater curvature, collar of helvetius, middle circular stomach muscle layers, longitudinal and circular muscles of the duodenum, the pylorus, and other structures proximate to the stomach. The catheter is sized and configured to be inserted orally or through a surgical opening. The length of the catheter is responsive to the relative size or age of the patient and the manner of insertion.  
         [0015]     The first and second treatment balloons may be comprised of kevlar, mylar, or any biologically non-reactive polymer. The first and second treatment balloons may include a plurality of micropores that can be used for delivery of irrigating fluids, chilling liquids or pharmaceutical agents. The first and second treatment balloons are capable of being expanded so as to be in proximity of the interior of a stomach, duodenum or organs adjacent thereto, such as the pylorus. The first and second treatment balloons include at least one localized receiver that is responsive to the potential of a nerve, impedence, temperature, current or voltage.  
         [0016]     The plurality of electrodes may include a set of needle-like electrodes. In one embodiment, the plurality of needle-like electrodes is arced. In one embodiment, each electrode includes a thermocouple. The transmission of energy from each electrode may be responsive to feedback from the thermocouple.  
         [0017]     In one embodiment, the electrodes are disposed to deliver radio frequency energy. The electrodes may also be disposed to deliver infrared light, microwave, ultrasound, electromagnetic, photodynamic therapy, or other forms of energy.  
         [0018]     In one embodiment, the apparatus includes a spacer so as to separate the first and second balloons in such a way that the first balloon delivers energy and liquids to the duodenum and the second balloon delivers energy and substances to a location in the stomach simultaneously or sequentially.  
         [0019]     In one embodiment, lumens conduct liquid or energy to and from a source external to the patient and a targeted portion of the interior of a stomach, duodenum and pylorus.  
         [0020]     An alternative apparatus for treatment of obesity includes a catheter capable of being disposed proximate to a junction between the stomach and the duodenum, a treatment balloon, a set of struts, a plurality of electrodes embedded in said set of struts, and a plurality of lumens. The catheter can be disposed, either by oral insertion or through a surgical opening, proximate to a gastric cardia, greater curvature, collar of helvetius, middle circular stomach muscle layers, longitudinal and circular muscles of the duodenum, the pylorus, and other structures in the digestive system.  
         [0021]     The length of the catheter may be responsive to the relative age or size of the patient and the manner of insertion. The treatment balloon may be comprised of kevlar, mylar, or any biologically non-reactive polymer.  
         [0022]     The treatment balloon may include a plurality of micropores that can be used for delivery of irrigating fluids, chilling liquids, or pharmaceutical agents. The treatment balloon may be capable of being expanded so as to cause the plurality of struts to be in immediate proximity to the interior of a stomach, duodenum, or organs adjacent thereto. The set of struts may encompass the exterior surface of the treatment balloon in such a way that expansion of the balloon causes outward movement of said struts.  
         [0023]     The electrodes may have at least one localized receiver that is responsive to the potential of a nerve, impedance, temperature, current, or voltage. The plurality of electrodes may include a set of needle-like electrodes. In one embodiment, the set of needle-like electrodes is arced. In one embodiment, each electrode in includes a thermocouple. The transmission of energy from each electrode may be responsive to feedback from the thermocouple. In one embodiment, the electrodes are disposed to deliver radio frequency energy. The electrodes may also be disposed to deliver infrared light, microwave, ultrasound, electromagnetic, photodynamic therapy, or other forms of therapeutic energy.  
         [0024]     In one embodiment, lumens conduct liquid or energy to and from a source external to the patient and a targeted portion of the interior of a stomach, duodenum, pylorus, or associated structure.  
         [0025]     A method is provided for treatment of obesity which includes inserting a catheter, either orally or through a surgical opening, into the stomach of a patient, identifying particular nervous tissue and other structures within the stomach and associated structures, inflating a first treatment balloon, inflating a second treatment balloon, and deploying at least one electrode in a tissue.  
         [0026]     Nervous tissue may be identified by visual inspection, measurement of nervous potential or impedance, or by other means.  
         [0027]     The first and second treatment balloons may be inflated with a chilled liquid, an irrigating liquid or a pharmaceutical agent. The chilled liquid, irrigating fluid, or pharmaceutical agent may be delivered to a tissue included in the stomach or duodenum through micropores in the first or second balloon.  
         [0028]     Deploying the at least one electrode may include creating thermal or other lesions in a stomach, duodenum, pyloris, or associated structures. Deploying the electrode may also include starting the flow of energy into a tissue through the electrode in response to feedback from a thermocouple or other sensor. Deploying the electrode may also include ablating a nerve so as to inhibit the relaxation of a stomach muscle. Deploying the electrode may also include delivering microwave, radio frequency, laser, infrared, ultrasound, or other therapeutic energy to the interior of a stomach, duodenum, or pylorus.  
         [0029]     Another method for treatment of obesity, includes inserting a catheter, either orally or through a surgical opening, into the stomach of a patient, identifying particular nervous tissue and other structures within the stomach and associated structures, inflating a treatment balloon in such a way that at least one strut is positioned relatively proximate to the interior wall of a stomach or a duodenum, and deploying at least one electrodes in a tissue.  
         [0030]     Nervous tissue may be identified by visual inspection, measurement of nervous potential or impedance, or by other means.  
         [0031]     The treatment balloon may be inflated with a chilled liquid, an irrigating liquid or a pharmaceutical agent. The chilled liquid, irrigating fluid, or pharmaceutical agent may be delivered to a tissue included in the stomach or duodenum through micropores in the treatment balloon.  
         [0032]     Deploying the at least one electrode may include creating thermal or other lesions in a stomach, duodenum, pyloris, or associated structures. Deploying the electrode may also include starting the flow of energy into a tissue through the electrode in response to feedback from a thermocouple or other sensor. Deploying the electrode may also include ablating a nerve so as to inhibit the relaxation of a stomach muscle. Deploying the electrode may also include delivering microwave, radio frequency, laser, infrared, ultrasound, or other therapeutic energy to the interior of a stomach, duodenum, or pylorus. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0033]      FIG. 1  is a block diagram of a first device used in a system for treatment of obesity.  
         [0034]      FIG. 2  is a block diagram of a second device used in a system for treatment of obesity.  
         [0035]      FIG. 3  is a block diagram of a control apparatus to be used with a first or second device in a system for treatment of obesity.  
         [0036]      FIGS. 4A and 4B  show a process flow diagram of a method for the treatment of obesity. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0037]     In the following description of a preferred embodiment of the invention is described with regard to preferred process steps and data structures. Those skilled in the art would recognize, after perusal of this application, that embodiments of the invention can be implemented using circuitry or other structures adapted to particular process steps and data structures, and that implementation of the process steps and data structures described herein would not require undue experimentation or further invention.  
         [0038]     System Elements  
         [0039]      FIG. 1  is a block diagram of a first device used in a system for treatment of obesity.  
         [0040]     A system  100  includes a treatment element  110 , a catheter  310  and a control apparatus  315 . The treatment element  110  is mounted on the most distal end of the catheter  310  in such a way that the treatment element  110  and catheter  310  form one contiguous piece. This Figure is restricted to the treatment element  110 . The catheter  310  and control apparatus  315  are described in greater detail in  FIG. 3 .  
         [0041]     The treatment element  110  includes a distal tip  111 , a first balloon  115 , a spacer  120 , a second balloon  125 , and a plurality of lumens (not shown). Both the first balloon  115  and second balloon  125  include a set of electrodes  135  and a set of thermocouples  136 .  
         [0042]     The distal tip  111  is composed of a long, relatively narrow tubular element composed of relatively stiff, biologically non-reactive plastic that is disposed for insertion into the stomach and the portion of the duodenum immediately proximate to the stomach. In a preferred embodiment, the distal tip  111  is an extension of the catheter  310  (described supra).  
         [0043]     The first balloon  115  is mounted between the distal tip  111  and the spacer  120 . In a preferred embodiment, the first balloon  115  is approximately three times as long as it is wide, with the long end running between the distal tip  111  and the spacer  120 . The walls of the first balloon  115  are comprised of mylar or a similar biologically non-reactive material that can be inflated with a variety of liquids such as saline, Ringers or water. In some embodiments, the first treatment balloon  115  includes micropores for delivery of liquid to a tissue. In these embodiments, pharmacological agents such as irrigating fluids, antibiotics, anti-inflammatories, anti-spasmodics and anesthetics can be exuded from micropores in the balloon  115 . Some of the lumens included in the plurality of lumens are dedicated to inflation and deflation of the first balloon  115 .  
         [0044]     The electrodes  135  are distributed equidistant to each other in concentric rings along a longitudinal axis of the first treatment balloon  115 . Each electrode  135  includes a thermocouple  136  so that the temperature of each electrode  135  can be monitored separately.  
         [0045]     In a preferred embodiment, the electrodes  135  included in the first balloon  115  are disposed to deliver RF energy to portions of the duodenum that are generally proximate to the stomach. In other embodiments, the electrodes  135  may be disposed to deliver microwave, laser, ELF (extremely low frequency) or other therapeutic energies.  
         [0046]     A spacer  120  lies between the first treatment balloon  115  and the second treatment balloon  125 . In a preferred embodiment, the spacer  120  lies in the same plane as the distal tip  115  and is composed of relatively stiff material comparable to that of the distal tip  115  and catheter. Although the size of the spacer  120  may vary (for example, a spacer  120  used in a device to treat children will be smaller than a spacer  120  used in a device to treat adults), the relative proportions between the spacer  120  and the size of the first and second treatment balloons  115  and  125  do not vary.  
         [0047]     In a preferred embodiment the spacer  120  separates the first treatment balloon  115  and second treatment balloon  125 , thereby allowing two separate and distinct areas (that is, areas in the duodenum and stomach) to be treated individually and simultaneously.  
         [0048]     The second treatment balloon  125  is mounted between the spacer  120  and the catheter  310  and control apparatus  315 . In a preferred embodiment, the shape of the second balloon  125  is similar to a bisected sphere with the center of the spherical side coupled to the spacer  120  and the flat portion coupled to the catheter  310 . The widest portion of the second treatment balloon  125  is approximately three times wider than the width of the first treatment balloon  120 . In a preferred embodiment, the second treatment balloon  125  is disposed in a stomach while the first treatment balloon  115  is disposed in a duodenum.  
         [0049]     Similar to the first treatment balloon  115 , the second treatment balloon  125  is comprised of mylar or other similar biologically non-reactive material that can be inflated with air or a variety of liquids such as saline, Ringers or water. In some embodiments of the invention, the second treatment balloon  125  includes micropores for delivery of a liquid to a tissue. In these embodiments, pharmacological agents such as irrigating fluids, antibiotics, anti-inflammatories, anti-spasmodics and anesthetics may be exuded from micropores in the balloon  125 . Some of the lumens included in the plurality of lumens  140  are dedicated to inflation and deflation of the second balloon  125 .  
         [0050]     The electrodes  135  are distributed equidistant to each other in concentric rings along a spherical portion of the second treatment balloon  115 . There are no electrodes  135  on the proximal side of the second treatment balloon  125  (that is, the portion of the balloon  125  coupled to the catheter  310  and control apparatus  315 ). Each electrode  135  includes a thermocouple  136  so that the temperature of each electrode  135  can be monitored separately.  
         [0051]     In a preferred embodiment, the electrodes  135  included in the second balloon  125  are disposed to deliver RF energy to portions of the stomach, in other embodiments, the electrodes  135  may be disposed to deliver microwave, laser, ELF (extremely low frequency) or other therapeutic energies.  
         [0052]     The lumens are disposed to control the electrodes  135 , transmit the RF energy or channel the fluids to the first treatment balloon  115  and the second treatment balloon  125 . All of the lumens traverse the entire length of the catheter  310  and terminate at the treatment element  110  at an electrode  135 , a thermocouple  136 , the interior of a first treatment balloon  115  or the interior of a second treatment balloon  125 .  
         [0053]      FIG. 2  is a block diagram of a second device used in a system for treatment of obesity.  
         [0054]     A system  200  includes a treatment element  210 , a catheter  310  and a control apparatus  315 . The treatment element  210  is mounted on the most distal end of the catheter  310  in such a way that the treatment element  210  and catheter  310  form one contiguous piece.  FIG. 2  is restricted to the treatment element  210 . The catheter  310  and control apparatus  315  are described in greater detail in  FIG. 3 .  
         [0055]     The treatment element  210  includes a distal tip  211 , a plurality of struts  215 , a balloon  220  and a plurality of lumens (not shown). The set of struts  215  includes a set of electrodes  235  and a set of thermocouples  236 .  
         [0056]     The distal tip  211  is composed of a long, relatively narrow tubular element composed of relatively stiff, biologically non-reactive plastic that is disposed for insertion into the stomach and the portion of the duodenum immediately proximate to the stomach. In a preferred embodiment, the distal tip  211  is an extension of the catheter  310  (described supra).  
         [0057]     The plurality of struts  215  is mounted between the distal tip  211  and catheter so that the distal end of each strut terminates at the proximal end of the distal tip  211  and the proximal end of each strut terminates at the catheter  310 . The length of struts included in the plurality of struts  215  between the distal tip  211  and catheter is between three and four times as long as the distal tip  211 . In a preferred embodiment, there are between ten and twenty individual struts  215 . Other embodiments may include different numbers of struts  215 .  
         [0058]     Each strut in the plurality of struts  215  includes at least one electrode from the plurality of electrodes  235 . Each electrode  235  includes a thermocouple  236  so that the temperature of each electrode  235  can be monitored separately. The electrodes  235  are slightly arced needle electrodes, mounted in such a way as to curve away from the distal tip  211 . Each electrode  235  is staggered along the length of the strut  215  relative to the other electrodes  235  so that taken together, the plurality of electrodes  235  are evenly distributed at different lengths along the struts  215 .  
         [0059]     In a preferred embodiment, the electrodes  235  are disposed to deliver RF energy to the stomach and portions of the duodenum that are generally proximate to the stomach. In other embodiments, the electrodes  235  may be disposed to deliver microwave, laser, ELF (extremely low frequency) or other therapeutic energies. The electrodes  235  may also be disposed to deliver a variety of substances such as cooling liquids and pharmaceutical agents.  
         [0060]     In addition to the struts  215 , a balloon  220  is also mounted between the distal tip  215  and the catheter  310 . The balloon  220  is coupled in such a way that the exterior portion of the balloon  220  is encircled by the set of struts  215 . Inflation of the balloon  220  causes the electrodes  235  to be brought into closer proximity to the targeted tissue in the duodenum and stomach. In a preferred embodiment, the balloon  220  can be inflated with a variety of cooling liquids such as saline, Ringers or water. In other embodiments, the balloon  220  includes a plurality of micropores. In such embodiments, pharmacological agents such as irrigating fluids, antibiotics, anti-inflammatories, anti-spasmodics and anesthetics can be exuded from micropores in the balloon. Some of the lumens included in the plurality of lumens are dedicated to inflation and deflation of the balloon  220 .  
         [0061]     The lumens are disposed to control the electrodes  235 , transmit the RF energy or channel the fluids to the treatment balloon  220 . All of the lumens  130  traverse the entire length of the catheter  310  and terminate at the treatment element  210  either at an electrode  235 , a thermocouple  236  or in the interior of a treatment balloon  220 .  
         [0062]      FIG. 3  is a block diagram of a control apparatus to be used with a first or second device in a system for treatment of obesity.  
         [0063]     A system  300  is used to control the delivery of energy, cooling fluids and pharmaceutical agents through the first and second devices described infra.  
         [0064]     A system  300  includes a catheter  310  and control mechanism  315 . The control mechanism  315  houses all the elements needed to control the treatment element  110  or treatment element  210 . As such, the control mechanism  315  includes a handgrip  320 , an electrode manipulation element  325 , a therapeutic energy connector  330 , an inflation control port  335  and a deflation control port  340 .  
         [0065]     The catheter  310  is coupled on the distal end to treatment element  110  or treatment element  210  and coupled on the proximal end to the control mechanism  315 . The catheter  310  is comprised of biologically non-reactive material and is sufficiently flexible so as to be introduced through the oral cavity, threaded through an esophagus and into a stomach. The overall length of the catheter may vary, but is responsive to the distance from a mouth to a duodenum. In alternative embodiments, the overall length of the catheter  310  may be responsive to the distance between a surgical incision and a duodenum. The catheter  310  is disposed to house lumens (not shown), which traverse the entire length of the catheter  310 .  
         [0066]     The electrode manipulation element  325  is mounted on the most distal portion of the control apparatus  325  immediately adjacent and contiguous with the handgrip  320 . The electrode manipulation element  325  is coupled to proximal end of some of the lumens  140 . As such, the electrode manipulation element  325  can be used to activate or deactivate electrodes included in systems  100  or  200 . These electrodes can be controlled either individually or in combination. Activation or deactivation is also responsive to feedback from thermocouples  136  or  236  or to the physician&#39;s professional judgment.  
         [0067]     The therapeutic energy connector  330  is mounted on the most proximal end of the control apparatus  325 . As such, it is coupled to the most proximal end of some of the lumens  140  or  240  that traverse the interior of the catheter  310  and handgrip  320 . In a preferred embodiment, the therapeutic energy connector  330  is disposed to be connected to an RF generator. In other embodiments, the therapeutic energy connector  330  can be disposed to be connected to a generator of microwaves, infrared, ELF, laser or other therapeutic energy.  
         [0068]     The inflation control port  335  is mounted immediately between the therapeutic energy connector  330  and the deflation control port  340  on the top portion of the control apparatus  325 . The proximal end of some of the lumens terminate at the inflation control port  325 .  
         [0069]     In a preferred embodiment, the inflation control port  335  is disposed to be coupled to a source of cooling liquids or pharmaceutical agents in liquid form. Examples of substances that can be introduced through the fluid input port  335  include sterile saline, sterile water, Ringers, antibiotic solutions, local anesthetics and other agents.  
         [0070]     Deflation control port  340  is immediately adjacent to the inflation control port  335 . The interior portion of the deflation control port  340  is coupled to some of the lumens in such a way that fluids used to inflate the first treatment balloon  115 , second treatment balloon  125  or treatment balloon  220  can be suctioned away and the balloons deflated.  
         [0071]     In a preferred embodiment the fluid output port  340  may be coupled to a pump or other apparatus to remove fluids. Pumping may occur in response to liquids entering the inflation control port  335 , so as to achieve a continuously circulating stream of cooling liquid.  
         [0072]     Method of Use  
         [0073]      FIGS. 4A and 4B  show a process flow diagram of a method for the treatment of obesity.  
         [0074]     A method  400  is performed by a system  100  or  200  and a system  300 .  
         [0075]     At a flow point  400 , the therapeutic energy connector  330  is coupled to art RF generator. In other embodiments, the therapeutic energy connector  330  is coupled to an RF generator. In other embodiments, the therapeutic energy connector  330  is coupled to other sources of therapeutic energy such as laser, ELF, infrared or microwave.  
         [0076]     At a step  405 , suction, inflation or fluid infusion apparatus is coupled to the inflation control port  235  and deflation control port  340  so that the balloons  115  and  125  or  220  may be inflated with a continuously circulating stream of liquids or pharmacological agents. The type of fluid used to inflate the balloons is responsive to the professional judgment of the physician.  
         [0077]     At a step  410 , the visualization apparatus such as a fluoroscope, an endoscope, a display screen or other visualization device is turned on and positioned so as to be used in a patient. The choice of visualization apparatus and method of use are responsive to judgments by medical personnel. If other equipment is needed (for example, monitoring equipment for patient vital signs), the equipment is prepared at this time.  
         [0078]     At a step  415 , the patient is positioned on a treatment table, in an appropriate position. Depending upon the professional judgment of the physician, varying degrees of local or general anesthesia may be induced.  
         [0079]     At a step  420 , the treatment element  110  or  210  is inserted through the oral cavity, distal tip first. Visualization apparatus is used to track the treatment element  110  or  210  as it is threaded through the esophagus. Upon entry into the stomach, the collar of helvetius, middle circular stomach muscle layers, longitudinal muscle of duodenum, circular muscle of the duodenum, pyloris and gastric cardia and other associated structures are identified. Regardless whether the first or second device is used, all of the treatment balloons associated with a particular device are deflated to facilitate inflation.  
         [0080]     At a step  425 , the tissues targeted for treatment are identified and the associated nerves are mapped. The treatment element  110  or  210  is positioned so as to be relatively proximate to a targeted area.  
         [0081]     At a step  430 , the inflation control port  335 , deflation control port  340  and equipment associated therewith are manipulated and the balloons associated with treatment elements  110  or  210  are inflated from a continuously circulating stream of cooling fluid such as saline, water, Ringers or other liquids. Inflation of the balloon(s)  115  and/or  125 , or balloon  220  brings electrodes  135  or electrodes  235  in contact with the targeted tissues. If treatment element  110  is used, balloons  115  and  125  may be inflated dependently or independently of each other. This circulating cooling liquid lowers the relative temperature of the targeted tissue and prevents collateral thermal damage that might otherwise occur. If a microporous balloon(s) is used, the balloon may also be inflated with pharmaceutical agents such as antibiotics, antacids, anti-inflammatories and other drugs including those that might be useful in pretreating the targeted areas. The choice of cooling liquid(s) and pharmaceutical agent(s) are responsive to the professional judgment of the physician.  
         [0082]     At a step  435 , the electrode manipulation element  325  is activated so as to select which electrodes included in the plurality of electrodes  135  or  235  are appropriate for treatment and to cause a release of energy from these selected electrodes. The duration and frequency of energy are responsive to judgments by medical personnel. This release of energy creates a pattern of lesions in the tissues of the stomach, duodenum and gastric cardia. Depending upon the professional judgment of the physician, energy may be directed toward nerves in the gastric cardia so as to prevent relaxation of stomach muscles. In other embodiments, treatment may include direct modulation of nerves associated with the sensation of satiety or tightening of tissues in portions of the stomach and duodenum that are proximate to each other. This step may be repeated in other portions of the stomach in a manner that is responsive to the professional judgment of the physician. In some embodiments of the invention, the second treatment balloon  125  includes micropores for delivery of liquid to a tissue.  
         [0083]     In a preferred embodiment, the temperature increase that accompanies the release of energy from each electrode  135  or  235  is monitored by the thermocouple  136  or  236  associated with that particular electrode in such a way that if the temperature approaches a preset limit, then that particular electrode is automatically deactivated.  
         [0084]     At a step  440 , the inflation control port  345  is manipulated so as to stop the flow of liquids into the system  100  or system  200 . This causes the balloons associated with treatment elements  110  or  210  to deflate.  
         [0085]     At a step  445 , the treatment element  110  or  210  is withdrawn from the stomach via the oral cavity. In embodiments that involve surgical introduction of the treatment element  110  or  210 , the element is removed through the surgical incision. Appropriate follow-up care is responsive to the professional judgment of the physician.  
       Alternative Embodiments  
       [0086]     Although preferred embodiments are disclosed herein, many variations are possible which remain within the concept, scope, and spirit of the invention, and these variations would become clear to those skilled in the art after perusal of this application.