Patent Document

PRIORITY 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/348,275, entitled “Methods and Devices for Regulating the Activation of Ghrelin Hormones within a Stomach,” filed May 26, 2010, the disclosure of which is incorporated by reference herein. 
     
    
     FIELD OF INVENTION 
       [0002]    The present invention relates to methods and devices for regulating the activation of ghrelin hormones within a stomach. 
       BACKGROUND OF THE INVENTION 
       [0003]    Ghrelin is a hormone produced mainly by P/D1 cells lining the majority of the human stomach. These cells are distributed throughout the stomach and portions of the duodenum, but are highly concentrated in the area of the fundus and along the greater curvature of the stomach. Ghrelin, commonly called the hunger hormone, is associated with eating and fasting cycles in the body. It has been found that ghrelin levels increase before meals and decrease after meals. Further, it has been discovered that ghrelin levels in the plasma of obese individuals are typically lower than those in leaner individuals, while those suffering from the eating disorder anorexia nervosa typically have high plasma levels of ghrelin compared to both the constitutionally thin and normal-weight controls. These findings suggest that ghrelin plays a role in weight disorders. 
         [0004]    Additionally, increased Ghrelin levels have been linked to enhanced learning and memory, a reduction in stress-induced depression, and shorter sleep durations. 
         [0005]    Accordingly, there remains a need for methods and devices for regulating the activation of ghrelin hormones within a stomach in order to treat weight disorders, to promote learning and memory functions, to treat stress-induced depression, and to promote healthy sleep duration. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention generally provides methods and devices for regulating the activation of ghrelin hormones within a stomach in order to treat weight disorders, to promote learning and memory functions, to treat stress-induced depression, and to control sleep duration. Through recent research, it has been discovered that the enzyme Ghrelin-Octanoyl Acyl-Transferase (GOAT) mediates the control of ghrelin activation within the stomach. While dietary lipids serve as a substrate for GOAT which is used for acylation of circulating ghrelin, ghrelin acylation by GOAT may depend on the presence of specific dietary lipids. GOAT/ghrelin is a gastrointestinal lipid sensing system, yet the secretion and activation of ghrelin are two independently regulated processes. It is believed that the primary means for activating ghrelin is through the contact of the ghrelin producing cells of the stomach and/or intestines with stomach contents carrying the GOAT enzyme and dietary lipids necessary for activating ghrelin. The activated ghrelin, Human-Acyl-Ghrelin, moves from the stomach and/or intestines into the blood stream and its levels may be measured in the blood through known testing procedures. It has been found through testing that the Human Acyl-Ghrelin levels present in the blood stream decrease under fasting conditions. Accordingly, increased Human Acyl-Ghrelin levels in the blood stream may not reflect an empty stomach as previously thought; rather these increased Human Acyl-Ghrelin levels in the blood stream may actually be a signal indicating the availability of specific dietary lipids which may prepare the body for optimal nutrient partitioning and storage. 
         [0007]    By blocking GOAT&#39;s access to ghrelin, ghrelin may be maintained in a non-activated state within the stomach, and may thereby reduce or eliminate hunger, promote learning and memory functions, treat stress-induced depression, and promote healthy sleep duration. Inversely, by facilitating GOAT&#39;s access to ghrelin, ghrelin may be maintained in an activated state within the stomach, and may thereby increase hunger or appetite, and alter healthy sleep duration. As may be appreciated, proper regulation of the activation of ghrelin hormones within a stomach may be utilized to treat or cure metabolic disorders, obesity, anorexia, depression, insomnia, learning or attention disorders, memory loss and the like. 
         [0008]    In one embodiment, a method for regulating activation of ghrelin hormones within a stomach comprises a means for isolating ghrelin producing cells from food content and dietary lipids within the stomach is provided. These means for isolating may take any number of forms and may comprise one or more of a surgical procedure, an implanted device, or an ingestible substance. 
         [0009]    In an exemplary method, the stomach may be partitioned into a first and second chamber; the first chamber containing and permitting flow therethrough of food content and dietary lipids; and the second chamber containing the bulk of the ghrelin hormone producing cells. Partitioning may be accomplished via a surgical procedure such as a Magenstrasse and Mill (M&amp;M) procedure or the like, through the implanting of a device such as a gastric sleeve or the like, or through a combination of a surgical procedure and an implanted device. The Magenstrasse and Mill (M&amp;M) procedure is an evolving gastroplasty technique wherein the greater curvature of the stomach is separated (e.g., stapled and cut) from the path of food, leaving a tube of stomach, the Magenstrasse, which is comprised of the lesser curvature. This procedure is similar to Vertical Banded Gastroplasty (VBG) except that the longitudinal separation line of the stomach extends further along the lesser curvature and into the antrum. The theory behind leaving the antral “mill” is that it will continue to serve its normal function of mixing, grinding, retropulsion, and well-orchestrated expulsion of chyme into the duodenum. Non-limiting disclosures of the M&amp;M procedure can be found in U.S. patent application Ser. No. 12/242,381, filed Sep. 30, 2008, entitled “Methods and Devices for Performing Gastroplasties Using Multiple Port Access”, and U.S. patent application Ser. No. 12/242,353, filed Sep. 30, 2008, entitled “Methods and Devices for Performing Gastrectomies and Gastroplasties” which are incorporated herein by reference. A non-limiting study on the operation is incorporated herein by reference in its entirety (Johnston et. al. The Magenstrasse and Mill Operation for Morbid Obesity; Obesity Surgery 13, 10-16). Non-limiting disclosure of the implanting of a bariatric sleeve devices can be found in U.S. Pat. No. 7,476,256 B2 to Meade et al., U.S. Pat. No. 7,347,875 B2 to Levine et al., U.S. Pat. No. 7,329,285 B2 to Levine et al., U.S. Pat. No. 7,267,694 to Levine et al., U.S. Pat. No. 7,122,058 B2 to Levine et al. and U.S. Pat. No. 7,025,791 B2 to Levine et al., which are hereby incorporated by reference in their entirety. The method further includes providing a means for preventing dietary lipids from contacting ghrelin producing cells, thus preventing GOAT from utilizing the dietary lipids to activate the ghrelin. The means for preventing dietary lipids from contacting ghrelin producing cells may be accomplished by at least one of a surgical procedure and an implanted device. The surgical procedure for preventing dietary lipids from contacting ghrelin producing cells may comprise creating a passive biological one-way valve via tissue folding and/or removal. The implanted device for permitting controlled evacuation of non-activated ghrelin hormones contained within the second stomach chamber may comprise an elongate tubular device having an internal bore; the device may further include a valve assembly. Exemplary valve assemblies may comprise at least one of a duck bill valve, a ball valve, a one-way osmotic membrane, and the like. 
         [0010]    Other means for isolating ghrelin producing cells from food content and dietary lipids within the stomach, such as introducing a substance within the stomach which substantially regulates the activation of ghrelin producing cells, or performing an ablation procedure on at least some ghrelin producing cells present within the stomach and/or intestines are also contemplated. These means may be provided alone or in concert with any other means for regulating activation of ghrelin producing cells within a stomach and/or intestines disclosed herein, in order to achieve the desired effect of treating or curing weight disorders, promoting learning and memory functions, treating stress-induced depression, and/or promoting healthy sleep duration. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: 
           [0012]      FIG. 1  is a schematic view of a human stomach. 
           [0013]      FIG. 2  is a schematic view of a human stomach following a Magenstrasse and Mill (M&amp;M) surgical procedure. 
           [0014]      FIG. 3  is schematic partially transparent view of a human stomach following a Magenstrasse and Mill (M&amp;M) surgical procedure and implantation of a controlled evacuation device. 
           [0015]      FIG. 4  is a schematic view of a human stomach following a Magenstrasse and Mill (M&amp;M) surgical procedure and creation of a passive biological one-way valve. 
           [0016]      FIG. 5A  is a schematic partially transparent view of a human stomach following the implantation of a gastric sleeve. 
           [0017]      FIG. 5B  is a schematic partially transparent view of a human stomach following the implantation of a gastric sleeve. 
           [0018]      FIG. 6A  is a cross-sectional view of a passive biological one-way valve in an open position. 
           [0019]      FIG. 6B  is a cross-sectional view of a passive biological one-way valve in a closed position. 
           [0020]      FIG. 7  is a schematic partially transparent view of a controlled evacuation device comprising a duck bill valve. 
           [0021]      FIG. 8  is a schematic partially transparent view of a controlled evacuation device comprising an internal ball valve. 
           [0022]      FIG. 9  is a schematic partially transparent view of a controlled evacuation device comprising an osmotic membrane. 
           [0023]      FIG. 10A  is a schematic view of a human stomach at a first step of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. 
           [0024]      FIG. 10B  is a schematic view of a human stomach at a second step of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. 
           [0025]      FIG. 10C  is a schematic view of a human stomach at a third step of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. 
           [0026]      FIG. 10D  is a schematic view of a human stomach at a forth step of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. 
           [0027]      FIG. 10E  is a schematic view of a human stomach at a fifth step of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. 
           [0028]      FIG. 11  is a schematic partially transparent view of a human stomach following the implantation of a duodenal sleeve. 
           [0029]      FIG. 12  is schematic partially transparent view of a human stomach following a Magenstrasse and Mill (M&amp;M) surgical procedure and implantation of a controlled evacuation device and a duodenal sleeve. 
           [0030]      FIG. 13  is schematic partially transparent view of a human stomach following a sleeve gastrectomy procedure and implantation of a duodenal sleeve. 
           [0031]      FIG. 14A  is schematic view of a unitary implantable hydrophilic foam barrier. 
           [0032]      FIG. 14B  is schematic view of a segmented ingestible hydrophilic foam barrier prior to suturing. 
           [0033]      FIG. 14C  is schematic view of a segmented ingestible hydrophilic foam barrier after suturing. 
           [0034]      FIG. 15A  is a schematic partially transparent view of a human stomach following a first step in a transoral introduction and laparoscopic fixation of a barrier. 
           [0035]      FIG. 15B  is a schematic partially transparent view of a human stomach following a second step in a transoral introduction and laparoscopic fixation of a barrier. 
           [0036]      FIG. 15C  is a schematic view of a human stomach following a third step in a transoral introduction and laparoscopic fixation of a barrier. 
           [0037]      FIG. 15D  is a schematic view of a human stomach following a transoral introduction and laparoscopic fixation of a barrier and details thereof. 
           [0038]      FIG. 15E  is a cross sectional view of a human stomach following a transoral introduction and laparoscopic fixation of a barrier and details thereof. 
           [0039]      FIG. 15F  is a schematic partially transparent view of a human stomach following a transoral introduction and laparoscopic fixation of a barrier illustrating a water path within the stomach. 
           [0040]      FIG. 15G  is a schematic partially transparent view of a human stomach following a transoral introduction and laparoscopic fixation of a barrier illustrating a lipid path within the stomach. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]    Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. 
         [0042]      FIG. 1  is a schematic view of a human stomach  100 . Esophagus  102 , which meets stomach  100  at antrum  104 , serves as an inlet for ingested food content. At the uppermost region of stomach  100  resides fundus  106 . Fundus  106  is the region of the stomach where most of the ghrelin hormone producing cells reside. Stomach  100  is generally defined by greater curvature  108  and lesser curvature  110 , and is bound by anterior wall  112 . At the lowermost region of the stomach reside angular notch  114 , pylorus  116  and duodenum  118 . Together, angular notch  114 , pylorus  116  and duodenum  118  serve as an outlet for the contents of the stomach to pass into the intestines (not shown); the digestive process being aided by gall bladder  122 . Ghrelin expression zones  120  are defined within stomach  100  in areas generally defined by fundus  106  and duodenum  118 . 
         [0043]      FIG. 2  is a schematic view of human stomach  100  following a Magenstrasse and 
         [0044]    Mill (M&amp;M) surgical procedure. The M&amp;M surgical procedure is generally accomplished by creating a vertical transection, division or separation  200  of the gastric cavity of stomach  100  generally along lesser curvature  110  from antrum  104  to a point roughly 4-6 cm from pylorus  116 . A transorally delivered bougie (not shown) is often placed into the pylorus. The bougie is pressed against lesser curvature  110  with a stapling device (not shown) and helps determine the location of separation  200 . The size of the bougie chosen by the surgeon aids in determining the size of the lumen of first stomach chamber  202 . The bougie also helps the surgeon create a lumen in chamber  202  that is uniform in diameter. As may be appreciated, the performance of an M&amp;M surgical procedure serves the function of partitioning stomach into a first chamber  202  and a second chamber  204 . First chamber  202  contains and permits flow therethrough of food content and dietary lipids (not shown). Second chamber  204  contains the bulk of the ghrelin hormone producing cells present in stomach  100 . It should be appreciated that similar procedures for separating the stomach, whether physically or virtually are contemplated and may be performed in place of or in concert with the M&amp;M surgical procedure disclosed herein. Details of such a procedure are disclosed herein with respect to  FIGS. 10A-10E . 
         [0045]      FIG. 3  is schematic partially transparent view of human stomach  100  following a Magenstrasse and Mill (M&amp;M) surgical procedure and implantation of a controlled evacuation device  300 . In this particular embodiment, controlled evacuation device  300  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  302  and an outlet  304 . In this particular embodiment, controlled evacuation device  300  is illustrated as a conical or funnel shaped device where inlet  302  substantially surrounds the space between vertical separation  200  and the bottom portion of anterior wall  112  to substantially create a seal between first chamber  202  and second chamber  204 , although it should be understood that various other shapes may be employed by one having ordinary skill in the art without departing from the scope of the present invention. Accordingly, in this embodiment, controlled evacuation device  300  may prevent contact within the stomach of the non-activated ghrelin cells and dietary lipids of first chamber  202  in order to induce or maintain a fat burning metabolic state, thereby causing weight loss in an obese patient. As will be discussed in greater detail later herein, controlled evacuation device  300  may comprise a valve which is functional to provide controlled one-way fluid flow therethrough, and to prevent retrograde flow of food content and dietary lipids through controlled evacuation device  300  by way of peristaltic stomach motions. As may be appreciated, controlled evacuation device  300  may have alternate forms and placements within stomach  100  without departing from the scope of the present invention. 
         [0046]      FIG. 4  is a schematic view of human stomach  100  following a Magenstrasse and Mill (M&amp;M) surgical procedure and creation of a passive biological one-way valve  400 . In this particular embodiment, passive biological one-way valve  400  is functional to regulate the contact between dietary lipids of first chamber  202  and the non-activated ghrelin cells contained within second chamber  204  in order to achieve a desired effect. Passive biological one-way valve  400  may be formed, for example, via tissue folding or tissue removal. Cross-sectional views of a passive biological one-way valve taken along section line A-A will be discussed in greater detail later herein with respect to  FIGS. 6A and 6B . Further, passive biological one-way valve  400  may also include an implantable prosthetic device such as a one-way osmotic membrane. As may be appreciated, passive biological one-way valve  400  may have alternate forms and placements within stomach  100  without departing from the scope of the present invention. 
         [0047]      FIGS. 5A and 5B  are schematic partially transparent views of human stomach  100  following the implantation of a gastric sleeve  500 . In these particular embodiments, gastric sleeve  500  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  502  and an outlet  504 . In these particular embodiments, gastric sleeve  500  is secured at its inlet  502  to esophagus  102  near antrum  104  via anchoring stent  506 . In  FIG. 5A , outlet  504  extends to a point beyond pylorus  116 , but terminates prior to ghrelin expression zone  120  of duodenum  118 . In  FIG. 5B , outlet  504  extends to a point beyond ghrelin expression zone  120  of duodenum  118 . In this manner, the length of gastric sleeve  500  may be tailored to the specific needs of the patient, as determined by their physician without departing from the scope of the present invention. Accordingly, food content and dietary lipids are effectively separated from the ghrelin hormone producing cells present in fundus  106  and/or duodenum  118 , thereby preventing activation of ghrelin by the enzyme Ghrelin-Octanoyl Acyl-Transferase (GOAT). This isolation may aid in reducing or eliminating hunger sensations, as well as inducing or maintaining a fat burning metabolic state, thereby causing weight loss in an obese patient. As may be appreciated, gastric sleeve  500  may have alternate forms and placements within stomach  100  with the primary function remaining as separating food content and dietary lipids from the ghrelin hormone producing cells present in fundus  106 . Further, it should be understood that known gastric sleeves and sleeve gastrectomy methods may be employed, without changing or altering the scope of the present invention. 
         [0048]      FIG. 6A  is a cross-sectional view of a passive biological one-way valve  400  in an open position, as taken along section line A-A of  FIG. 4 . As disclosed previously herein, passive biological one-way valve  400  may be formed, for example, via tissue plication or tissue removal. Accordingly, in this particular embodiment, passive biological one-way valve  400  includes a first tissue fold  602  and a second tissue fold  604  which cooperate to form a valve which separates second chamber  204  of stomach  100  from the formed outlet chamber  606 . In the open position of  FIG. 6A , the stomach fluids contained within second chamber  204  are free to be evacuated into outlet chamber  606 , and subsequently through outlet passage  608 . As may be appreciated, passive biological one-way valve  400  may have alternate forms (e.g., one or more plications may be created to obtain the desired effect) and placements within stomach  100  with the primary function remaining as controlling evacuation of stomach fluids from second chamber  204 . 
         [0049]      FIG. 6B  is a cross-sectional view of a passive biological one-way valve  400  in a closed position, as taken along section line A-A of  FIG. 4 . As disclosed previously herein, passive biological one-way valve  400  may be formed, for example, via tissue plication or tissue removal. Accordingly, in this particular embodiment, passive biological one-way valve  400  includes a first tissue fold  602  and a second tissue fold  604  which cooperate to form a valve which separates second chamber  204  of stomach  100  from the formed outlet chamber  606 . In the closed position of  FIG. 6B , the stomach fluids contained within second chamber  204  are collected before being evacuated into outlet chamber  606 , and subsequently through outlet passage  608 . In this embodiment, dietary lipids are prevented from contacting the ghrelin producing cells in second chamber  204 . As may be appreciated, passive biological one-way valve  400  may have alternate forms and placements within stomach  100  with the primary function remaining as controlling evacuation of stomach fluids from second chamber  204 . 
         [0050]      FIG. 7  is a schematic partially transparent view of a controlled evacuation device  700  comprising a duck bill valve. In this particular embodiment, controlled evacuation device  700  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  702  and an outlet  704 . Within the internal bore resides a duck bill valve formed by a first elongated member  706  and a second elongated member  708 . First elongated member  706  and a second elongated member  708  are resiliently biased to a normally closed configuration as seen in  FIG. 7 , but allow for passage of materials therethrough. In one embodiment, the material passing therethrough is the stomach fluids contained within second chamber  204  as described previously herein with respect to  FIG. 3 . 
         [0051]      FIG. 8  is a schematic partially transparent view of a controlled evacuation device  800  comprising an internal ball valve. In this particular embodiment, controlled evacuation device  800  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  802  and an outlet  804 . Within the internal bore resides a ball valve formed by a first elongated member  806  and a second elongated member  808  which interact with a ball  810 . Ball  810  may be resiliently biased to a normally closed configuration as seen in  FIG. 8 , but allow for passage of materials therethrough. In one embodiment, the material passing therethrough is the stomach fluids contained within second chamber  204  as described previously herein with respect to  FIG. 3 . As may be appreciated, ball  810  may be constructed of a suitable material such as Polyetheretherketone (PEEK) or silicone and have a suitable size and shape for use within a human stomach. 
         [0052]      FIG. 9  is a schematic partially transparent view of a controlled evacuation device  900  comprising an osmotic membrane. In this particular embodiment, controlled evacuation device  900  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  902  and an outlet  904 . Within the internal bore resides an osmotic membrane  906 . Osmotic membrane  906  allows for one-way fluid passage therethrough. In one embodiment, the fluid passing therethrough is the stomach fluids contained within second chamber  204  as described previously herein with respect to  FIG. 3 . 
         [0053]      FIGS. 10A-10E  illustrate a schematic view of human stomach  100  undergoing the basic steps of a modified Magenstrasse and Mill (M&amp;M) type surgical procedure. In  FIG. 10A , a first division or separation  1000  is created in stomach  100 . In  FIG. 10B , a second division or separation  1002  is created in stomach  100 . In  FIG. 10C , first division or separation  1000  is separated to create two distinct stomach chambers; first stomach chamber  202  and second stomach chamber  204 . In  FIG. 10D , second division or separation  1002  is also separated to further define first stomach chamber  202  and second stomach chamber  204 . In  FIG. 10E , second stomach chamber  204  is secured to inert structural tissue  1004  in the abdominal cavity of the patient by sutures  1006  or the like. In this manner, narrow passage  1008  between first division or separation  1000  and second division or separation  1002  serves as the only fluid communication passage between first stomach chamber  202  and second stomach chamber  204 , thereby controlling the fluid communication between the dietary lipids contained within first stomach chamber  202  and the ghrelin hormone producing cells present second stomach chamber  204 . This in turn prevents activation of the non-activated ghrelin cells which will induce or maintain a fat burning metabolic state, thereby causing weight loss in an obese patient. As may be appreciated, passage  1008  may further include a valve means (not shown) which may, for example, comprise either an implanted mechanical device or a surgically created biological one-way valve which have been detailed previously herein in other embodiments. 
         [0054]      FIG. 11  is a schematic partially transparent view of human stomach  100  following the implantation of a duodenal sleeve  1100 . In this particular embodiment, duodenal sleeve  1100  is anchored at its inlet  1108  by anchoring stent  1102  within duodenum  118 . In these particular embodiments, duodenal sleeve  1100  is an implanted device having a tubular configuration with an internal bore passing therethrough, thereby defining an inlet  1108  and an outlet  1110 . In  FIG. 11 , outlet  1110  of duodenal sleeve  1100  extends to a point beyond ghrelin expression zone  120  of duodenum  118  (see  FIG. 1 ). In this manner, the length of duodenal sleeve  1100  may be tailored to the specific needs of the patient, as determined by their physician without departing from the scope of the present invention. Accordingly, food content and dietary lipids  1104  pass through duodenal sleeve  1100  in a direction indicated by flow arrow  1106  and are effectively separated from the ghrelin hormone producing cells present in duodenum  118 , thereby preventing activation of ghrelin by the enzyme Ghrelin-Octanoyl Acyl-Transferase (GOAT). This isolation may aid in reducing or eliminating hunger sensations, as well as inducing or maintaining a fat burning metabolic state, thereby causing weight loss in an obese patient. As may be appreciated, duodenal sleeve  1100  may have alternate forms and placements within duodenum  118  with the primary function remaining as separating food content and dietary lipids from the ghrelin hormone producing cells present in duodenum  118 . Further, it should be understood that known duodenal sleeves and sleeve gastrectomy methods may be employed, without changing or altering the scope of the present invention. 
         [0055]      FIG. 12  is schematic partially transparent view of human stomach  100  following a Magenstrasse and Mill (M&amp;M) surgical procedure and implantation of a controlled evacuation device  1200  and a duodenal sleeve  1100 . Controlled evacuation device  1200  includes an inlet  1202  and an outlet  1204  and comprises a valve which is functional to provide controlled one-way fluid flow therethrough, and to prevent retrograde flow of food content and dietary lipids through controlled evacuation device  1200  by way of peristaltic stomach motions. Accordingly, in this embodiment, controlled evacuation device  1200  may prevent contact within the stomach of the non-activated ghrelin cells and dietary lipids of first chamber  202  in order to induce or maintain a fat burning metabolic state, thereby causing weight loss in an obese patient. As may be appreciated, controlled evacuation device  1200  may have alternate forms (e.g., a passive biological one-way valve as in  FIG. 4  above) and placements within stomach  100  without departing from the scope of the present invention. The M&amp;M procedure of  FIG. 12  is equivalent to that of the M&amp;M procedure detailed previously herein with respect to  FIG. 2 . The implantation of duodenal sleeve  1100  is equivalent to that of the procedure detailed previously herein with respect to  FIG. 11 . 
         [0056]      FIG. 13  is schematic partially transparent view of human stomach  100  following a sleeve gastrectomy procedure and implantation of a duodenal sleeve  1100 . In  FIG. 13 , a division or separation  1302  is created in stomach  100  in order to create two distinct stomach portions; first portion  1304  and second portion  1306 . In this embodiment, second portion  1306  comprising fundus  106  is excised leaving stomach  100  having portion  1304  as its new effective volume. In this manner, the ghrelin producing portions of fundus  106  are removed from the body and are therefore incapable of being contacted by the dietary lipids and food content within stomach  100 . Non-limiting disclosures of the sleeve gastrectomy procedure can be found an example of this is disclosed in US2005/0131386A1, Jun. 16, 2005 “METHOD AND DEVICE FOR MINIMALLY INVASIVE IMPLANTATION OF BIOMATERIAL”, which is hereby incorporated by reference in their entirety. The implantation of duodenal sleeve  1100  is equivalent to that of the procedure detailed previously herein with respect to  FIG. 11 . 
         [0057]      FIGS. 14A-C  are schematic views of hydrophilic foam barrier  1400 . In  FIG. 14A , hydrophilic foam barrier  1400  is a unitary implantable device, whereas in  FIGS. 14B and 14C  barrier  1400  is a segmented ingestible device. In these figures, barrier  1400  is constructed from multiple smaller sections  1402 . Each section  1402  would be small enough to pass in the expanded state shown. One embodiment of a construction method would be to hold the sections together with bioabsorbable suture  1404 . That way, barrier  1400  could be implanted in one easily maneuverable piece, but would break up into passable sections in the unlikely event that it becomes dislodged from the gastric fixturing means (discussed below). The idea described in this document uses a moist barrier to repel lipids from areas of the stomach or small bowel that contain GOAT. In one embodiment, barrier  1400  is a highly hydrophilic and is constructed of a porous material. 
         [0058]      FIGS. 15A-C  are schematic partially transparent views of human stomach  100  following a transoral introduction and laparoscopic fixation of hydrophilic foam barrier  1400 .  FIG. 15A  illustrates a first step in the process wherein barrier  1400  is rolled, compressed and inserted into stomach  100  orally.  FIG. 15B  illustrates a second step in the process wherein barrier  1400  is unrolled and positioned in fundus  106  using a flexible endoscope with standard tools (not shown).  FIG. 15C  illustrates a third step in the process wherein using a laparoscopic device  1500 , the anterior and posterior layers of stomach  100  are forced into contact with barrier  1400 , not compressing the barrier fully. Fasteners  1502  are inserted through the anterior stomach layer, barrier  1400  and the posterior stomach layer in order to hold barrier  1400  in place. 
         [0059]      FIGS. 15D-E  are a schematic view and cross sectional view respectively of human stomach  100  following a transoral introduction and laparoscopic fixation of an hydrophilic foam barrier  1400  and details thereof. As shown and described previously herein with respect to  FIGS. 15A-C ,  FIG. 15D  illustrates barrier  1400  fastened between the anterior stomach layer and the posterior stomach layer via fasteners  1502  and further includes a section line A-A.  FIG. 15E  as taken along section line A-A illustrates barrier  1400  fastened between the anterior stomach layer and the posterior stomach layer via fasteners  1502  in order to be better understood. 
         [0060]      FIGS. 15F-G  is are schematic partially transparent views of human stomach  100  following a transoral introduction and laparoscopic fixation of a barrier illustrating a water path and a lipid path respectively within stomach  100 . In  FIG. 15F  a portion of water  1504  introduced by ingestion is retained in barrier  1400 . Also, secretions from fundus area  106  of stomach  100  can pass through barrier  1400  for drainage, because they are water based. However, as seen in  FIG. 15G , ingested lipids  1506  are repelled by barrier  1400  due to the fact that the porous material is engorged with water  1504 , and lipids  1506  are hydrophobic. Therefore, it is ensured that lipids  1506  do not contact the GOAT containing tissue within fundus  106 . This isolation may aid in reducing or eliminating hunger sensations, as well as inducing or maintaining a fat burning metabolic state, thereby causing weight loss in an obese patient. 
         [0061]    One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Technology Category: 1