Abstract:
A device, system and method for providing tissue and organ restriction. A device is described with respect to restricting gastric capacity while avoiding nutritional deficiencies and other complications. Additionally, a system and method are described for using the device to restrict gastric capacity to perform a non surgical gastric procedure.

Description:
PRIORITY 
     The present application is related to, and claims the priority benefit of, International Patent Application Serial No. PCT/US2008/000837, filed Jan. 23, 2008, which: (1) is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 60/881,838, filed Jan. 23, 2007; and (2) is related to, and claims the priority benefit of, International Patent Application Ser. No. PCT/US2007/015238, filed Jun. 29, 2007, which is related to, and claims the priority benefit of, U.S. Provisional Patent Application Serial No. 60/817,423, filed Jun. 30, 2006. The contents of each of these applications are hereby incorporated by reference in their entirety into this disclosure. 
    
    
     BACKGROUND 
     Obesity and overweight conditions are a global epidemic and are the most frequent nutritional disorder in Western civilization. Currently, the conditions of “overweight” and “obesity” are classified by body mass index (“BMI”), which is a statistical measure of the weight of a person scaled according to height. From the period of 1988-1994 to the period of 1999-2000, the incidence of overweight adults augmented from 55.9% to 64.5% while the prevalence of obesity increased from 22.9% to 30.5%. The United States especially faces grave public policy concerns with respect to the morbidly obese, i.e. being over 100 pounds above their desirable weight or having one or more serious medical conditions in association with obesity. 
     In order to treat obesity, conventional procedures involve attempts to either 1) restrict food intake into the body via a restrictive bariatric procedure (a “Restrictive Procedure”), or 2) alter the anatomy of the small intestine or divert the peristalsis of a person&#39;s normal food intake past the small intestine to decrease caloric absorption via a malabsorptive bariatric procedure, which is commonly known as a gastric bypass (a “Malabsorptive Procedure”). It is also known to combine the two procedures such that both of the aforementioned techniques are employed jointly. 
     Each of the abovementioned procedures has advantages and disadvantages. The Malabsorptive Procedures, which entail short circuiting the gastric pouch, have previously been more successful in bringing about sustained weight loss; however, they are typically more difficult to perform, have higher rates of catastrophic post-operative complications, and produce long-term deleterious changes due to the rerouting of the alimentary flow. Restrictive Procedures have encountered more success than Malabsorptive Procedures because the Restrictive Procedures tend to be simpler, have fewer major complications, and do not disturb normal digestive tract continuity. 
     In Malabsorptive Procedures, an intestinal bypass is typically performed. This results in the exclusion of almost all of the small intestine from the digestive tract, such that a lower amount of calories and nutrients can be absorbed. One example of a specific Malabsorptive Procedure is the biliopancreatic diversion (“BPD”). BPD is a procedure in which about three-fourths (¾) of the stomach is removed in order to restrict food intake and decrease stomach acid production. The effect of this procedure is to alter the anatomy of the small intestine via the formation of an alimentary limb. The alimentary limb diverts the passage of food past the first portion of the small intestine, including the duodenum and jejunum, thereby preventing all of the bile and pancreatic juices from digesting the ingested food. As briefly noted above, this process does not come without significant risks. 
     Conversely, in Restrictive Procedures a passageway is generally constructed from the upper portion of the stomach to the lower portion, thereby preventing the stomach from storing large amounts of food and slowing the passage of food from the esophagus to the small intestine. Conventional Restrictive Procedures rely on the banding and/or stapling of the stomach to create a small pouch on the superior portion of the stomach near the gastroesophageal junction. When first created, this pouch can contain no more than approximately one (1) ounce of food and liquid, but typically later distends to store two (2) to three (3) ounces. 
     The lower outlet of the created pouch is nondilatable and is typically only one half (½) inch in diameter or smaller. The small pouch receives food and liquid directly from the esophagus and fills quickly. The pouch also diverts the passage of food and liquid to the lower portion of the stomach, thus avoiding storage of food in the stomach itself. Due to the pouch&#39;s size and the relatively narrow outlet into the larger stomach, the patient experiences early satiety, which in turn decreases appetite and results in weight loss. Purely Restrictive Procedures for obesity include adjustable gastric banding and vertical banded gastroplasty. These procedures do not affect the digestive process and thus do not result in the risks associated with Malabsorptive Procedures. In addition, Restrictive Procedures are safer than Malabsorptive Procedures and can be performed laparoscopically, thereby further reducing risks of complications. 
     In all Restrictive Procedures, the volume of the small pouch above the band can increase in size up to ten (10) times after the initial operation. Therefore, the pouch volume during surgery needs to initially be very small. To enable the patient to consume sufficient nutrition immediately after the operation considering such a small gastric pouch  11 , the opening to the stomach initially must be relatively large. Thereafter, as the pouch volume increases, the stoma opening must be subsequently reduced to enjoy optimal results of the procedure. In addition, the size of the stoma opening should be gradually reduced during the first year after surgery as the gastric pouch continues to increase in size. 
     One Restrictive Procedure, adjustable gastric binding (“AGB”), provides an adjustment means, thereby enabling minor post-operation adjustments of the size of the stoma opening. In AGB, a band is placed around the superior portion of the stomach to form a small pouch and a narrow passageway to the rest of the stomach. The band itself typically comprises a hollow silicone rubber band having an inflatable cavity. The inflatable cavity of the band is capable of being inflated with a fluid—typically an isotonic salt solution—through a tube that connects the band to an access port, which is typically located subcutaneously so that it may be easily accessed by the patient. Over time, the band may be tightened or loosened to modify the size of the stoma opening by increasing or decreasing the quantity of fluid within the cavity of the band. By adding liquid to the cavity of the band, the band expands radially inward and decreases the size of the stoma opening. 
     A great disadvantage of AGB, however, is that as a result of the direct manipulation of the bands, the rubber bands forming the gastric pouch tend to slip or wear away. In addition, in the conventional AGB process where the fluid is added to the band cavity by way of an injection into the access port, repeated injections into the same area increases the risk of infection in the area surrounding the access port. In addition, it is uncomfortable for the patient when the necessary post-operation adjustments of the stoma opening are carried out by using a needle to access the port through the skin. 
     Similar to AGB, vertical banded gastroplasty (“VBG”) is a Restrictive Procedure that utilizes rubber bands as well as staples to create the small stomach pouch. Unlike AGB, however, VBG is not manually adjustable. The VBG procedure involves puncturing the stomach to create a pouch. Like AGB, VBG is prone to slippage and/or band deterioration. Additional complications also may arise with VBG, including staple-line disruption, which can result in stomach content leakage and/or serious infection. Such complications may require prolonged hospitalization with antibiotic treatment and even additional operations. Based on the associated risks, VBG has been classified by the American Medical Association as a “severely dangerous” operation. 
     Combined operations consisting of Malabsorptive and Restrictive Procedures are the most common bariatric procedures performed today. Such combined procedures restrict both food intake and the amount of calories and nutrients that the body is capable of absorbing. An example of a combined procedure is the Extended (Distal) Roux-en-Y Gastric Bypass (“RYGBP-E”) in which a stapling creates a small (approximately 15 to 20 cc) stomach pouch completely separated from the remainder of the stomach. The small intestine is divided just beyond the duodenum (the hollow tube connecting the stomach to the jejunum), and is re-arranged into a Y-configuration to enable outflow of food from the small upper stomach pouch, via a “Roux limb”. Accordingly, the small intestine forms the outlet of the newly formed stomach pouch, which empties directly into the lower portion of the jejunum, thus bypassing caloric absorption. The length of either segment of the intestine can be increased to adjust the levels of malabsorption. 
     Because the duodenum is bypassed in this procedure, poor absorption of iron and calcium can result in a decreased total body iron concentration and a predisposition to iron deficiency anemia. Additional complications of the RYGBP-E procedure include a condition known as “dumping syndrome”. Normally, the pyloric valve at the lower end of the stomach regulates the release of food into the bowel. Dumping syndrome is a condition in which the stomach contents rapidly pass into the small intestine resulting in extremely unpleasant conditions including nausea, weakness, sweating, faintness and, on occasion, diarrhea after eating. Because sugar passes especially rapidly into the bowel, some patients are unable to eat any form of sweets after RYGBP-E surgery. 
     Being obese has many health ramifications. Obesity is an important risk factor for a number of diseases and increases risk factors that heavily predispose for cardiovascular disease. In addition, systemic hypertension, pulmonary hypertension (left ventricular failure, chronic hypoxia), and coronary heart disease all occur at very high rights in obese individuals and may be the source or influence in cardiac structure and function alterations. The risk of sudden cardiac death is also elevated in obese individuals. 
     Accordingly, a need exists for a safe and effective method of treating obesity. The current Restrictive, Malabsorptive, and combination procedures present a high risk of several complications, including malnutrition, infections, vomiting, and recurrence resulting from band slippage or deterioration. There is therefore a need for a new restrictive, nonsurgical technique that is not subject to the complications associated with the conventional procedures known in the art. 
     SUMMARY 
     Devices, systems and methods are provided for the treatment of obesity and, specifically, for restricting the medically effective volume of a stomach. In one embodiment, the device comprises a probe comprising at least one lumen and a plurality of openings therein, a puncturing device for insertion within the at least one lumen of the probe, and a vacuum source. Embodiments of the device can be endoscopically placed within the stomach and operated to create two stomach portions. The first portion of the stomach is for the primary digestion of ingested food, while the second portion of the stomach is bypassed in the digestive process. 
     In additional embodiments, a device is provided for restricting the capacity of a stomach and forming a gastric evacuation channel. The device comprises a double-lumen probe having a plurality of openings and a plurality of suction ports, a vacuum source, and a component comprising a plurality of retractable needles. The component comprising the plurality of retractable needles may further include a sheath configured to encase the component such that the retractable needles will be retracted therein and shielded from surrounding tissue or organs. In one embodiment, the component is further configured to be slidably inserted within the lumen of the probe operatively connected with the plurality of openings and the vacuum source is configured to be coupled with the lumen of the probe operatively connected to the plurality of suction ports. In this manner, suctional force provided through the plurality of suction ports can be used to attract and adhere to an interior wall of a stomach such that two stomach portions are formed. Further, the plurality of retractable needles can be used to puncture an interior wall of a stomach by extending through the plurality of openings. 
     In yet another embodiment, the plurality of retractable needles comprise hollow needles and are capable of applying an adhesive to a tissue. In one embodiment, the plurality of retractable needles can be used to pierce a stomach wall such that the adhesive is applied to the exterior wall of the stomach. In certain embodiments, a first magnetic adhesive comprising a first polarity and a second magnetic adhesive comprising an opposite polarity can be applied to the external walls of the stomach through the retractable needles. In one embodiment, the first magnetic adhesive can be applied to the exterior of the posterior wall of the stomach and the second magnetic adhesive can be applied to the anterior wall of the stomach. In this manner, the attractive magnetic force between the adhesive particles functions to pull the two walls of the stomach together and thereby maintain and stabilize the division between two stomach portions. In certain other embodiments, an additional adhesive may be delivered through the probe to the interior of the stomach to form a continuous seal between the anterior and posterior walls of the stomach such that the two portions of the stomach do not communicate. 
     In another embodiment, a system and method is provided for using the devices disclosed herein to reduce the medically effective volume of a stomach. One embodiment of the system comprises a device for restricting the capacity of a stomach and a balloon. The balloon is capable of being endoscopically delivered to the stomach and of inflating to a predetermined size. In some embodiments, the balloon serves as a model for the desired volume of the first stomach portion. In yet another embodiment, a method is provided for endoscopically placing the device and balloon into a stomach, suctioning the anterior and posterior walls of the stomach together to form a first stomach portion and a second stomach portion, puncturing the stomach walls to deliver a magnetic adhesive to the exterior of the anterior and posterior stomach walls; and sealing the interior junction between the anterior and posterior stomach walls to ensure minimal communication between the first stomach portion and the second stomach portion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  shows a side view of at least one embodiment of a probe and a shaft of a gastric remodeling device; 
         FIG. 1B  shows a side view of at least one embodiment of the gastric remodeling device shown  FIG. 1A ; 
         FIG. 1C  shows a cross-sectional view of at least one embodiment of the shaft of the gastric remodeling device shown in  FIG. 1A ; 
         FIG. 1D  shows a side view of at least one embodiment of the gastric remodeling device shown in  FIG. 1A  having a plurality of needles extended therefrom; 
         FIG. 2A  shows a perspective view of at least one embodiment of a gastric remodeling device; 
         FIG. 2B  shows a side view of one embodiment of the components of the gastric remodeling device shown in  FIG. 2A ; 
         FIG. 2C  shows a cross-sectional view of the gastric remodeling device of  FIG. 2B  taken along axis B-B; 
         FIG. 2D  shows a cross-sectional view of the gastric remodeling device of  FIG. 2B  taken along axis A-A; 
         FIG. 3A  shows a side view of a system comprising at least one embodiment of the gastric remodeling device of  FIGS. 1A-1D  and a balloon positioned within a stomach; 
         FIG. 3B  shows a top, cross-sectional view of the system shown in  FIG. 3A  positioned within a stomach; 
         FIG. 4  shows a flow chart of one embodiment of a method for using the gastric remodeling device of  FIGS. 2A-2D  to create a small gastric pouch in a stomach; 
         FIG. 5A  shows a perspective view of the outside of a stomach that has been divided into a first stomach portion and a second stomach portion by at least one embodiment of the gastric remodeling device of  FIGS. 2A-2D ; and 
         FIG. 5B  shows a cross-sectional view of the stomach of  FIG. 5A  taken along axis C-C. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of scope is intended by the description of these embodiments. 
       FIGS. 1A-1D  show several views of at least one embodiment of a gastric remodeling device  10 . In this embodiment, the gastric remodeling device  10  enables a clinician to resize a patient&#39;s stomach, while avoiding the nutritional deficiencies observed with Malabsorptive Procedures. Further, the gastric remodeling device  10  does not require sutures or staples that could lead to dehiscence (e.g., the opening of the suture site) or fistula (e.g., an abnormal connection between organs or intestines). Moreover, application of the embodiments of the gastric remodeling device  10  to reduce the medically effective size of a stomach do not produce a significant amount of regurgitation and vomiting, which are commonly observed in connection with conventional methods used to treat obesity. 
     In the embodiment shown in  FIGS. 1A ,  1 B,  1 C, and  1 D, the gastric remodeling device  10  is comprised of an esophagogastric malleable probe comprising a first component  12  and a second component  13 . The first component  12  of the gastric remodeling device  10  comprises an elongated probe having a proximal end  20 , a distal end  22 , and an interior  24 . The interior  24  of the first component  12  extends throughout the length of the first component  12  and provides a channel through which the distal end  22  of the first component  12  may be accessed when the distal end  22  of the first component  12  is positioned within a body. 
     As shown in  FIG. 1B , the proximal end  20  of the first component  12  comprises a vacuum port  28  and a device port  29 . Both the vacuum port  28  and the device port  29  communicate with the interior  24  of the first component  12 . For example, when a device is inserted into the device port  29 , the device is slidably received by the interior  24  such that the device can be extended to the distal end  22  of the first component  12 . Further, when a suctional force is applied by a vacuum source to the vacuum port  28 , the force is communicated throughout the interior  24  of the first component  12  and a vacuum is created therein. In one embodiment, a syringe or other vacuum source (not shown) may be coupled with the vacuum port  28  in order to provide appropriate suction throughout the interior  24  of the first component  12 . It will be understood that any type of vacuum source may be used to supply suction throughout the interior  24 , such as a controlled vacuum system providing specific suction pressures. 
     The distal end  22  of the first component  12  comprises a plurality of openings  26  disposed thereon. Each of the plurality of openings  26  is in communication with the interior  24  of the first component  12 . Further, each of the plurality of openings  26  comprises a configuration capable of attaching to a targeted tissue  75 . When a vacuum source is coupled with the vacuum port  28  and an appropriate amount of suctional force is applied, a vacuum is created within the interior  24  of the first component  12 , which, in turn, produces an amount of suction through the plurality of openings  26 . If sufficient suctional force is provided, the suction within the plurality of openings  26  can effectively pull a targeted tissue  75  into contact with the first component  12  such that a releasable seal is formed therewith. Further, this releasable seal can be maintained for as long as sufficient suctional force is supplied by the vacuum source. 
     The second component  13  of the gastric remodeling device  10  comprises an elongated shaft  14 . The shaft  14  is configured be slidably received by the interior  24  of the first component  12  and comprises a proximal end  40 , a distal end  42 , an interior, and a plurality of needles  44 . The plurality of needles  44  extend from both sides of the shaft  14  and, in at least one embodiment, are concentrated at the distal end  42  thereof. In another embodiment, the location of the needles  44  on the shaft  14  corresponds with the placement of the openings  26  on the first component  12 , such that when the distal end  42  of the second component  13  is inserted within the interior  24  of the first component  12 , the needles  44  protrude through the openings  26  of the first component  12  (see  FIG. 1D ). 
     In at least one embodiment, each of the needles  44  comprises an open tip and a hollow configuration such that a channel  60  is disposed therethrough. The channel  60  is in communication with the interior of the shaft  14  and extends to the open tip of each needle  44  such that a substance can be introduced at the proximal end of the shaft  40 , advanced through the interior of the shaft  14 , advanced through the channel  60  of the needle  44 , and delivered to a targeted tissue through the open tip. 
     In an alternative embodiment shown in  FIG. 1C , the interior of the shaft  14  may comprise a first channel  48  and a second channel  49  extending along the length of the shaft  14 . In this embodiment, the needles  44  of the first component  12  are also arranged into a first set of needles  44  and a second of needles  44 A. In the embodiments shown in  FIG. 1C , the first set of needles extends from one side of the shaft  14  and the second set of needles extends from a second side of the shaft  14 . Further, the two channels  48 ,  49  of the shaft  14  are in fluid communication with the hollow interiors of the needles  44  and  44 A, respectively. Specifically, the first channel  48  communicates with the channels  60  of the first set of needles  44  and the second channel  49  communicates with the channels  60  of the second set of needles  44 A. In this manner, different materials may be inserted through the first and second channels  48 ,  49  for delivery through the first and second sets of needles  44 , respectively. 
     Accordingly, different materials can be inserted into the first channel  48  and the second channel  49  for delivery to the targeted tissue  75 . For example, one substance can be advanced through the first channel  48 , through the channels  60  of each of the needles  44  comprising the first set of needles  44 , and delivered to the targeted tissue  75  through the open tips of each of those needles  44 . Likewise, the same steps can be repeated with a second substance using the second channel  49  and the channels  60  of the second set of needles  44 A. In this manner, a clinician may use the independent first and second channels  48 ,  49  to deliver different substances to the targeted tissue without combining the substances. In one embodiment, a magnetic glue having a first polarity may be delivered through the first channel  48 , while a magnetic glue having an opposite polarity can be concurrently delivered through the second channel  49 . As the two channels  48 ,  49  are independent, the two polarities of glue can be separately applied to the targeted tissue through the same shaft  14 . 
     While in one embodiment the first and second channels  48 ,  49  extend from the proximal end  40  of the shaft  14  to the distal end  42  of the shaft  14 , it will be understood that the channels  48 ,  49  may comprise any length and, furthermore, need not be similarly configured. For example, in one embodiment, the first channel  48  extends into the distal end  42  of the shaft  14 , whereas the second channel  49  only extends partially throughout the length of the shaft  14 . Additionally, while the first channel  48  and the second channel  49  are shown in  FIG. 1C , it will be appreciated that the interior of the shaft  14  may comprise any number of channels extending therethrough. 
     Each of the plurality of needles  44  is capable of moving between a first resting position and a second retracted position when a force is applied. When no force is applied to the plurality of needles  44  (i.e. the needles  44  are in a resting state), the plurality of needles  44  are positioned in the first resting position. Each of the plurality of needles  44  can be moved into the second retracted position by applying a force. As each of the plurality of needles  44  are biased towards the first resting position, when force is no longer applied, the plurality of needles  44  automatically return to the first resting position. 
     In one embodiment, when the needles  44  are in the first resting position, the needles  44  are substantially perpendicular to the shaft  14 . Further, when the plurality of needles  44  are moved to the second retracted position, the needles  44  are substantially parallel to the shaft  14  and, in one embodiment, lay flat thereon. In another embodiment, when the needles  44  are in the first resting position, each of the needles  44  form about a 45° angle with the shaft  14  (see  FIG. 1A ). In yet another embodiment, when the plurality of needles  44  are in the first resting position, each of the needles  44  form less than a 90° angle with the shaft  14  and extend away from the proximal end  40  of the shaft  14 . 
     As shown in  FIGS. 1A and 1C , the second component  13  may further comprise a sheath  16  having a tubular body, at least one open end, and a lumen. The lumen of the sheath  16  is configured to slidably receive the shaft  14  therein. Further, the sheath  16  is configured to be slidably received by the interior  24  of the first component  12 , such that when the sheath  16  is received therein, the plurality of openings  26  of the first component  12  can still communicate with the interior  24  of the first component  12 . In other words, the diameter of the sheath  16  is less than the diameter of the interior  24 . 
     When the sheath  16  is applied over the shaft  14 , the sheath  16  supplies the requisite force to transition the plurality of needles  44  of the shaft  14  from the first resting position to the second retracted position. In this manner, when the sheath  16  is applied over the shaft  14 , the plurality of needles  44  lay in the second retracted position within the lumen of the sheath  16 . Further, when the sheath  16  is slidably removed from the shaft  14 , the plurality of needles  44  return to the first resting position. 
     Now referring to  FIGS. 2A-2D , at least one embodiment of a gastric remodeling device  100  is shown. Unlike the gastric remodeling device  10  previously described, the gastric remodeling device  100  comprises a first component  112  having a double-lumen probe. 
     The gastric remodeling device  100  comprises a proximal end  120 , a distal end  122 , a first component  112 , and the second component  13 . It will be understood that the second component  13  of the gastric remodeling device  100  is identical to the second component  113  of the gastric remodeling device  10  described in conjunction with  FIGS. 1A-1D . Accordingly, the configuration of the second component  13  will not be described in detail with respect to the gastric remodeling device  100 , and like reference numerals between  FIGS. 1A-1D  and  FIGS. 2A-2D  will refer to like components. 
     As shown in  FIGS. 2A and 2B , the first component  112  comprises an elongated double-lumen probe having a first end  140 , a second end  142 , an interior  124 , a plurality of openings  126 , and a plurality of suction ports  130 . The interior  124  of the first component  112  is divided into two cavities: a vacuum channel  101  and a lumen  103 . Both the vacuum channel  101  and the lumen  103  each define an interior space. The vacuum channel  101  is for suction and infusion, and the lumen  103  is for slidably receiving the second component  113 . The sizes of the vacuum channel  101  and the lumen  103  can vary depending on the specific application for which the gastric remodeling device  100  is used. 
     As shown in  FIGS. 2C and 2D , the vacuum channel  101  is disposed around the circumference of the first component  112  and the lumen  103  is disposed within the interior  124  of the first component  112 . In this manner, the lumen  103  is wholly surrounded by the vacuum channel  101 . It will be appreciated that the vacuum channel  101  and the lumen  103  may be disposed in any fashion within the interior  124  of the first component  112  so long as the vacuum channel  101  communicates with the plurality of suction ports  130  of the first component  112 . For example, although the vacuum channel  101  and the lumen  103  are shown in  FIG. 2A  as extending from the first end  140  of the first component  112  along a substantial portion of the length of the first component  112 , the vacuum channel  101  and the lumen  103  may or may not span the entire length of the first component  112 . Particularly, in at least one embodiment, the vacuum channel  101  does not extend to the second end  142  of the first component  112  to ensure that the suction may be distributed relatively evenly around the circumference of the first component  112  through a plurality of suction ports  130  (as is further discussed below). 
     The lumen  103  is capable of slidably receiving the second component  13  through the first end  140  of the first component  112 , and is further in communication with a plurality of openings  126  disposed on the second end  142  of the first component  112 . As such, the plurality of needles  44  of the second component  13  may extend through the plurality of openings  126  when the second component  13  is inserted into the lumen  103  and the shaft  16  is withdrawn. 
     The vacuum channel  101  is capable of operative connection with a vacuum source at the first end  140  of the first component  112 . In one embodiment, when a vacuum source is applied to the vacuum channel  101  at the first end  140 , the suctional force is communicated throughout the vacuum channel  101  along the length of the first component  112  and a vacuum is created therein. A syringe or other vacuum source (not shown) may be coupled with the vacuum channel  101  of the first component  112 . It will be understood that any type of vacuum source may be used to supply suction throughout the vacuum channel  101 , such as a controlled vacuum system providing specific suction pressures. At the second end  142  of the first component  112 , a plurality of suction ports  130  are in communication with the vacuum channel  101  for contacting a targeted tissue  75 . Each of the plurality of suction ports  130  may comprise any configuration that is capable of attaching to the targeted tissue  75  such that a reversible seal with the targeted tissue  75  is formed when the vacuum source is activated and coupled with the vacuum channel  101 . 
     In clinical application, the gastric remodeling devices  10 ,  100  may be used to non-surgically and reversibly adjust the medically effective volume of a stomach  77 . Specifically, the gastric remodeling devices  10 ,  100  may be employed to form a small gastric pouch  150  that extends from the gastroesophageal junction (“GEJ”)  80  to the duodenum  82  (see  FIG. 3A ). Further, the gastric remodeling device  10 ,  100  may be applied such that a gastric evacuation channel is further formed adjacent to the duodenum  82 . The small gastric pouch  150  comprises an inlet at the GEJ and an outlet at the duodenum  82 , which are the customary entrance for food and fluid entering the stomach  77  and the customary exit for digested food and fluid leaving the stomach  77 , respectively. Therefore, even with the gastric remodeling device  10 ,  100  restricting the medically effective volume of the stomach  77 , food digestion occurs through the normal digestive process, thereby avoiding any interruption in the absorption of vitamins and electrolytes typically resulting from Malabsorptive Procedures. 
     In one embodiment, the gastric remodeling device  100  is used in conjunction with a balloon  50  to form the small gastric pouch  150 . The balloon  50  can be any mannequin balloon known in the art as long as the balloon  50  can be introduced endoscopically and the volume of the balloon  50  can be modified when the balloon  50  is positioned within a stomach. When used in conjunction with the gastric remodeling device  10 ,  100 , the balloon  50  serves as a model for the volume of the small gastric pouch  150  that is desired. In other words, the balloon  50  provides a reference point for the clinician with respect to the desired size of the effective volume of the stomach, thereby facilitating accuracy and increasing the overall speed of the procedure. While the application of the gastric remodeling device  10 ,  100  is described in conjunction with a balloon  50  to facilitate the proper sizing of the effective volume, it will be appreciated that the gastric remodeling device  10 ,  100  can be delivered to the stomach without the use of a balloon  50  or other modeling device. Furthermore, the gastric remodeling device  10 ,  100  can be used in conjunction with any other modeling device known in the art, so long as the modeling device is capable of endoscopic insertion. 
     Now referring to  FIG. 4 , a flow chart is shown of a method  300  for using the gastric remodeling device  100  to reduce the effective size of a stomach. For ease of understanding, the steps of the related methods described herein will be discussed relative to components of the gastric remodeling device  100  shown in  FIGS. 2A-2D , but it will be appreciated by one skilled in the art that any such system or device can be used to perform these methods, including without limitation the gastric remodeling device  10 , so long as the device has a probe, a shaft that is slidably moveable with respect to the probe, a plurality of needles, and a plurality of vacuum ports for attaching to a targeted tissue. 
     At step  202 , the balloon  50  is introduced into a stomach  77  endoscopically under fluoroscopic control. In one embodiment, the balloon  50  is positioned adjacent to the lesser curvature of the stomach, as shown in  FIG. 3A . Once the balloon  50  is properly positioned within the stomach, the balloon  50  is inflated to the desired size through a tube or other means commonly known in the art. At step  204 , the gastric remodeling device  100  is endoscopically introduced into the stomach of the patient. Prior to inserting the gastric remodeling device  100  into the patient, the sheath  16  of the second component  13  is applied over the shaft  14  and the second component  13  is slidably engaged with the interior  124  of the first component  112 . As such, the plurality of needles  44  of the shaft  14  are not exposed when the gastric remodeling device  100  is endoscopically introduced. After the components of the gastric remodeling device  100  are properly configured, the distal end of the gastric remodeling device  10  is delivered to the stomach  77  endoscopically under fluoroscopic control. 
     In one embodiment, the gastric remodeling device  100  is positioned immediately adjacent to the balloon  50  and situated such that the plurality of openings  126  on each side of the first component  112  are adjacent to the anterior and posterior walls of the stomach  77 . After the gastric remodeling device  100  is positioned in the desired location within the stomach  77 , at step  206  the gastric remodeling device  100  engages the interior stomach walls using a suctional force. Specifically, a vacuum source is coupled with vacuum channel  101  and used to supply suction therethrough along the length of the first component  112 . In this manner, a suctional force is exerted through the plurality of suction ports  130 , which pulls the anterior and posterior walls of the stomach  77  into contact with the first component  112 . As, in this embodiment, the gastric remodeling device  100  is positioned immediately adjacent to the balloon  50 , the suction effectively wraps the walls of the stomach  77  around the balloon  50 . Further, the stomach walls are held in place around the balloon  50  for as long as the suction is supplied through the vacuum channel  101  of the first component  112 . As shown in  FIGS. 3A and 3B , the stomach is now divided into two sections, a small gastric pouch  150  having a volume substantially equal to the volume of the inflated balloon  50  contained therein, and a residual gastric chamber  160  that is bypassed in digestive functions. 
     With the walls of the stomach  77  securely coupled to the gastric remodeling device  100 , at step  208  the balloon  50  may optionally be deflated and removed through the esophagus  80 . Alternatively, the method  300  may proceed directly from step  206  to step  210  and withdraw the balloon  50  at some later point in the procedure. At step  210 , the sheath  16  is withdrawn through the proximal end  120  of the first component  112 , thereby deploying the plurality of needles  44  against the portions of the interior stomach wall that are suctioned against the gastric remodeling device  100 . Specifically, when the sheath  16  is slidably removed from the shaft  14 , there is no longer a force holding the plurality of needles  44  in the second retracted position. Accordingly, as previously described, each of the needles  44  automatically shifts from the second retracted position to the first resting position. The plurality of needles  44  aligned with the plurality of openings  126  extend through the plurality of openings  126 , thereby puncturing the interior anterior and posterior walls of the stomach suctioned thereto. In one embodiment, the plurality of needles  44  completely puncture the stomach walls such that the open tips of the needles  44  clear the exterior wall of the stomach  77 . 
     In one embodiment, the shaft  14  may be slightly advanced or withdrawn within the first component  112  of the gastric remodeling device  100  to facilitate the complete puncture of the stomach walls. Fluoroscopic vision may further be utilized at step  210  to assist in controlling the penetration of the plurality of needles  44  through the walls of the stomach  77 . Further, in at least one embodiment, the vacuum source increases the amount of suctional force supplied at step  210  in order to ensure that an adequate amount of pressure is maintained between the plurality of needles  44  and the interior walls of the stomach when the plurality of needles  44  are deployed. 
     After the plurality of needles  44  successfully puncture the stomach walls, an adhesive is advanced through the interior of the shaft, the channels  60  of the needles  44 , and onto the exterior of the stomach  77  at step  212 . The adhesive may comprise any micromagnetic adhesive known in the art, including without limitation, microbeads, magnetic liposomes, or other magnetic glue beads. In the embodiment of the interior of the shaft  14  of the gastric remodeling device  100  comprises a first channel  48  and a second channel  49  and the shaft comprises a first and second set of needles  44 , the first and second channels  48 ,  49  may be employed to prevent magnetic adhesives comprising opposite polarities from mixing. Specifically, in this embodiment, a magnetic adhesive comprising a first polarity is injected into the first channel  48  and advanced through the proximal end of the shaft  14 , the channels  60  of the first set of needles  44 , and out of the open tips of the needles  44 . In this manner, the magnetic adhesive comprising a first polarity is applied to the posterior exterior surface of the stomach  77 . Concurrently or thereafter, a magnetic adhesive comprising an opposite polarity is applied to the anterior exterior surface of the stomach  77  in the same manner: the magnetic adhesive comprising the opposite polarity is injected into the second channel  49  and advanced through the proximal end of the shaft  14 , the channels  60  of the second set of needles  44 , and out of the open tips of the needles  44 . 
     As the two sets of needles  44  are positioned on opposite sides of the stomach (through both the anterior and posterior walls), the two exterior stomach surfaces are coated with attracting particles or attracting magnetic liposomes. In this manner, a magnetic force is generated that provides a sandwiching effect on the stomach wall, thereby forcing the collapse of the stomach  77  along the line of adhesive application. Further, the magnetic force is sufficient to hold the stomach walls together without the assistance of the gastric remodeling device  100 . Accordingly, at step  212 , the suction provided through the vacuum channel  101  of the first component  112  is no longer required to maintain the division between the small gastric pouch  150  and the residual gastric chamber  160 . 
     At step  214 , the suctional force provided by the vacuum source through the vacuum channel  101  is ceased and the gastric remodeling device  100  is slowly withdrawn under fluoroscopic control. In the event the balloon  50  has not yet been withdrawn from the stomach  77 , the balloon  50  is also withdrawn at this step. As the gastric remodeling device  100  is withdrawn, a second adhesive is delivered to the interior walls of the stomach  77  adjacent to where the posterior wall and the anterior walls meet. Specifically, the second adhesive may be injected to the interior  124  of the first component  112  and applied to the tissue through the plurality of openings  126  in the first component  112 . Alternatively or concurrently, the second adhesive may be injected into the vacuum channel  101  and applied to the tissue through the plurality of suction ports  130 . In this manner, a seal is formed on the interior of the stomach  77  between the anterior and posterior gastric walls that held together by the magnetic force generated by the magnetic adhesive applied to the exterior of the stomach walls. After a sufficient amount of time has passed to allow the adhesive to form a seal within the interior of the stomach, a radioscopic control may be performed to corroborate the gastric pouch size (i.e. the size of the first stomach section  70 ), the sealing continuity, and to identify any possible leaks that may exist. 
     Using the gastric remodeling devices  10 ,  100  described herein in the treatment of obesity avoids the nutritional deficiencies observed after Malabsorptive Procedures, does not require sutures or staples which may lead to dehiscence or fistula formation, or produce the degree of regurgitation and vomiting observed in connection with conventional methods. Moreover, each of the devices described herein may be inserted into the body cavity endoscopically, thereby decreasing the stress associated with the procedure and the patient&#39;s recovery time. It will be recognized by one of skill in the art that any of the devices described herein may be employed in combination with the other conventional bariatric procedures. 
     While various embodiments of devices, systems, and methods for restricting the medically effective size of a stomach have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the disclosure. It will therefore be understood by those skilled in the art that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the disclosure. Indeed, this disclosure is not intended to be exhaustive or to limiting. The scope of the disclosure is to be defined by the appended claims, and by their equivalents. 
     Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations on the claims. In addition, the claims directed to a method and/or process should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present disclosure. 
     It is therefore intended that this description and the appended claims will encompass, all modifications and changes apparent to those of ordinary skill in the art based on this disclosure.