Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a divisional of application Ser. No. 13/356,401, filed on Jan. 23, 2012, the entire contents of which are incorporated herein by reference. 
    
    
     FIELD 
     The present invention generally relates to medical systems, devices and uses thereof for treating obesity and/or obesity-related diseases. More specifically, the present invention relates to an implant for replicating one or more satiety inducing mechanisms associated with gastric banding system. 
     BACKGROUND 
     Gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically placed gastric band (e.g., the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP BAND AP® (Allergan, Inc., Irvine, Calif.) gastric band). Generally, gastric bands are placed about the cardia, or upper portion, of a patient&#39;s stomach forming a stoma that restricts the food&#39;s passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. 
     The interface between the physician and the patient at any point post-operation is generally limited to the physician injecting or removing fluid via the access port implanted in the patient&#39;s body to further promote weight loss. Metrics such as volume, pressure and patient response (e.g., vomiting, nausea, poor weight loss, and the like) are monitored to determine appropriate band pressure and stoma size. 
     However, certain patients might not desire having an access port implanted, for instance, as the access port may be aesthetically unpleasing. Therefore, what is needed is an alternative obesity treatment system. 
     Some attempts have been made to provide for an alternative obesity treatment system. For example, Kagan, et al., U.S. Patent Pub. No. 2004/0148034, discloses a non-adjustable artificial stoma implant with a connection to a gastric sleeve as illustrated in  FIG. 1A . However, the cuff and sleeve of Kagan, et al., is very complex and may require an invasive implantation/removal procedure. In addition, the cuff and sleeve of Kagan do not replicate an internal gastric band. More particularly, the cuff functions as an anchor for the malabsorptive gastric sleeve and does not assist the peristaltic bolus transport. 
     Laufer, et al., U.S. Patent Pub. No. 2009/0018389, discloses performing restriction via tissue plication with adjustability from technique as illustrated in  FIG. 1B . However, performing restriction via tissue plication has been shown to encourage erosion and/or necrosis. 
     Stack, et al., U.S. Pat. No. 7,431,725, discloses forming plications and then coupling or seating medical devices against the plications as illustrated in  FIG. 1C . However, such a system also suffers from the drawback of encouraging erosion and/or necrosis. 
     Shalon, et al., U.S. Patent Pub. No. 2010/0137891, discloses a passive GEJ implant for treatment of GERD as illustrated in  FIG. 1D . However, the system of Shalon, et al., does not function to limit food transport into the stomach, but only discourages reflux from entering the esophagus to combat excessive GERD. 
     Taylor, et al., U.S. Patent Pub. No. 2004/0243152, discloses stomach volume restriction via serosal constriction as illustrated in  FIG. 1E . However, Taylor, et al., requires a very complex system which includes rotating inner and outer device layers. 
     However, neither of these provide for a self-adjusting esophageal dilation implant for the treatment of obesity, or related apparatus, methods or systems thereof. 
     SUMMARY 
     Generally described herein are apparatus, systems and methods related to a novel esophageal device implantable in the patient&#39;s body and designed to replicate the restrictive and satiety mechanism associated with gastric banding systems known in the art. In one or more embodiments, the device can be a compliant and tubular-shaped artificial stoma and fixated within the gastro-esophageal lumen using tissue anchors. 
     In this manner, the device is a minimally invasive, non-surgical alternative to existing restriction and satiety inducing devices currently used to treat obesity. In addition, the device is compliant and may, in certain embodiments, require no direct adjustment performed by a physician. The highly compliant nature of the device renders it self-adjusting (and thus obstruction tolerant) such that the device can form and shape with peristalsis, thereby naturally moving the bolus through the restriction. Even in the embodiments which allows for physician adjustments, implant manipulation is performed under full endoscopic vision. Furthermore, the device can be removed non-surgically, using full endoscopic instrumentation. This provides a benefit to patients who are adverse to surgery or cannot be operated on. 
     An intragastric device for the treatment of obesity is described and shown. The intragastric device includes a compliant portion containing a gel, an anchoring portion defining an opening and integral with the compliant portion, and a tissue fixation component for insertion through the opening of the anchoring portion. The tissue fixation component is capable of penetrating or configured to penetrate a patient tissue to attach the anchoring portion and the compliant portion in an intragastric position, thereby treating obesity. The opening can be a hole, a lumen, a channel, an orifice, or other space that can receive or allow passage of the tissue fixation component. 
     In one embodiment, provided is an endoscopic device fixable to a patient&#39;s mucosal-serosal tissue for the treatment of obesity. The endoscopic device includes a compliant portion filled with a gel for emulating natural peristaltic behavior, an anchoring portion connected to the compliant portion having a plurality of holes, and a tissue fixation component for penetrating a corresponding hole of the plurality of holes. The tissue fixation component is configured for further penetrating the patient&#39;s mucosal-serosal tissue to fix the anchoring portion and the compliant portion in place. 
     In one embodiment, provided is an endoscopic device fixable to a patient&#39;s mucosal-serosal tissue for the treatment of obesity. The endoscopic device includes a compliant, low-durometer body housing a low viscosity fluid and configured to emulate natural peristalsis such that when a bolus of food contacts a top portion of the housing, the fluid is transferred in a downward direction, and when the bolus of food contacts a middle portion of the housing, the fluid is transferred in both an upward and downward direction, and when the bolus of food contacts a bottom portion of the housing, the fluid is transferred in an upward direction. 
     In one embodiment, provided is an endoscopic device fixable to a patient&#39;s mucosal-serosal tissue for the treatment of obesity. The endoscopic device includes a housing defining a food passage, and a conical valve housed within the housing. The conical valve is configured for controlling a restriction of the food passage such that reducing separation between the housing and the conical valve increases the restriction of the food passage. 
     In one embodiment, provided is an endoscopic device fixable to a patient&#39;s mucosal-serosal tissue for the treatment of obesity. The endoscopic device includes a housing defining an opening, and a plurality of pivotable plates attached to the housing such that manipulation of the plates controls a size of the opening. 
     In one embodiment, provided is an endoscopic device insertable into a patient&#39;s digestive track and for the treatment of obesity. The endoscopic device includes a stent for migration resistance and for maintaining fixation to a patient&#39;s digestive tract when implanted into the patient&#39;s digestive tract, the stent defining a passageway for a bolus of food, a gel-filled, pliable and compliant artificial stoma for emulating natural peristaltic behavior and further extending the passageway for the bolus of food, the artificial stoma coupled to the stent, and a liner disposed between the stent and the artificial stoma, the liner configured to couple the stent to the artificial stoma and further extending the passageway for the bolus of food. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The features, obstacles, and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein: 
         FIG. 1A  illustrates a prior art, non-adjustable artificial stoma implant with a connection to a gastric sleeve. 
         FIG. 1B  illustrates a prior art, tissue plication device. 
         FIG. 1C  illustrates a prior art, tissue plication device. 
         FIG. 1D  illustrates a prior art, GEJ implant for treatment of GERD. 
         FIG. 1E  illustrates a prior art, stomach volume restriction via serosal constriction. 
         FIG. 2A  illustrates a self-adjusting esophageal implant according to an embodiment of the present invention. 
         FIG. 2B  illustrates the self-adjusting esophageal implant of  FIG. 2A  according to an embodiment of the present invention. 
         FIG. 2C  illustrates a cross-sectional view of the self-adjusting esophageal implant of  FIG. 2B  according to an embodiment of the present invention. 
         FIG. 2D  illustrates an anchor member for the implant of  FIG. 2A  according to an embodiment of the present invention. 
         FIG. 2E  illustrates the anchor member of  FIG. 2D  according to an embodiment of the present invention. 
         FIG. 2F  illustrates a self-adjusting esophageal implant disposed within a patient&#39;s body according to an embodiment of the present invention. 
         FIG. 2G  illustrates an anchor member for the implant of  FIG. 2F  according to an embodiment of the present invention. 
         FIG. 2H  illustrates the anchor member of  FIG. 2F  according to an embodiment of the present invention. 
         FIG. 3A  illustrates one embodiment of a compliant, self-adjusting endoscopic device according to an embodiment of the present invention. 
         FIG. 3B  illustrates the operation of the endoscopic device of  FIG. 3A  with respect to a bolus of food according to an embodiment of the present invention. 
         FIG. 3C  illustrates the operation of the endoscopic device of  FIG. 3A  with respect to a bolus of food according to an embodiment of the present invention. 
         FIG. 3D  illustrates the operation of the endoscopic device of  FIG. 3A  with respect to a bolus of food according to an embodiment of the present invention. 
         FIG. 3E  illustrates the operation of the endoscopic device of  FIG. 3A  with respect to a bolus of food according to an embodiment of the present invention. 
         FIG. 4A  illustrates a conical valve in a first position according to an embodiment of the present invention. 
         FIG. 4B  illustrates the conical valve of  FIG. 4A  in a second position according to an embodiment of the present invention. 
         FIG. 4C  illustrates a top view of the conical valve of  FIG. 4A  according to an embodiment of the present invention. 
         FIG. 4D  illustrates a bottom view of the conical valve of  FIG. 4A  according to an embodiment of the present invention. 
         FIG. 5A  illustrates an iris mechanism related to controlling the size of a stoma in a first position according to an embodiment of the present invention. 
         FIG. 5B  illustrates the iris mechanism of  FIG. 5A  in a second position according to an embodiment of the present invention. 
         FIG. 6A  illustrates a top view of an endoscopic device having a variably sized opening according to an embodiment of the present invention. 
         FIG. 6B  illustrates a cross sectional, side view of the endoscopic device of  FIG. 6A  according to an embodiment of the present invention. 
         FIG. 6C  illustrates a top view of the endoscopic device of  FIG. 6A  transporting a bolus of food according to an embodiment of the present invention. 
         FIG. 6D  illustrates a cross sectional, side view of the endoscopic device of  FIG. 6A  transporting a bolus of food according to an embodiment of the present invention. 
         FIG. 7  illustrates a top view of an endoscopic device having a variably sized opening according to an embodiment of the present invention. 
         FIG. 8  illustrates a top view of an endoscopic device having a variably sized opening according to an embodiment of the present invention. 
         FIG. 9A  illustrates one embodiment of an endoscopic device disposed within the esophagus of a patient according to an embodiment of the present invention. 
         FIG. 9B  illustrates the endoscopic device of  FIG. 9A  according to an embodiment of the present invention. 
         FIG. 9C  illustrates a top perspective view of the endoscopic device of  FIG. 9A  according to an embodiment of the present invention. 
         FIG. 9D  illustrates a side view of the endoscopic device of  FIG. 9A  according to an embodiment of the present invention. 
         FIG. 10  illustrates one embodiment of an endoscopic device disposed within the esophagus of a patient according to an embodiment of the present invention. 
         FIG. 11  illustrates one embodiment of an endoscopic device disposed within the esophagus of a patient according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Apparatuses, systems and/or methods that implement the embodiments of the various features of the present invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate some embodiments of the present invention and not to limit the scope of the present invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. 
       FIG. 2A  illustrates an esophageal implant device  205  implanted into a patient&#39;s esophageal junction between an esophagus  206  and a stomach  200 . These devices can also be referred to as intragastric devices. As shown, the esophageal implant device  205  is fixed within the esophageal lumen via tissue fixation means  215  anchoring the esophageal implant device  205  in place through a plurality of holes  220 . That is, each of the plurality of holes  220  may have its own corresponding tissue fixation means  215 . Furthermore, the number of holes  220  and corresponding tissue fixation means  215  may be configured as desired. 
     The esophageal implant device  205  functions to emulate natural tissue behavior (e.g., esophageal constriction, expansion, peristalsis, and the like) to allow the transport of food boluses through the esophageal implant device  205 , albeit at a potentially slower rate due to the restriction caused by the esophageal implant device  205 . More particularly, the natural tissue behavior emulated by the esophageal implant device  205  is produced, at least in part, by the compliance of the esophageal implant device  205  which may be due to the gel (or saline) or other appropriate compliance producing filling  210 . 
       FIG. 2B  illustrates the esophageal implant device  205  outside of the patient&#39;s body and shown without the tissue anchors for the sake of clarity. The esophageal implant device  205  may be bell-shaped (or cylindrical-shaped with an outwardly tapered bottom end or hour-glass shaped) with the portion of the esophageal implant device  205  extending into the stomach of the patient flaring outwards (i.e., similar to an inverted funnel). That is, in one embodiment, the circumference of a bottom portion  260  of the esophageal implant device  205  where a food bolus exits is larger than a circumference of a top portion  255  where the food bolus enters the esophageal implant device  205 . 
     As shown in the cross-sectional illustration of  FIG. 2C , the esophageal implant device  205  may be compliant, lowdurometer (e.g., 0-30 Shore A) and gel-filled or saline-filled. In one embodiment, the esophageal implant device  205  may be divided by a separating wall  225  into an anchoring portion  230  having the holes  220  and a compliant portion  235 . The anchoring portion  230  may be unfilled or constructed out of a sturdier material such as a polymer, while the compliant portion  235  may be filled with a compliant gel or other appropriate filling  210 . The filling  210  may be silicone or other gel materials (e.g., as derived from breast implant devices or dermal filling applications). The separating wall  225  prevents the filling  210  from entering into the anchoring portion  230 . 
     In one or more alternative embodiments, the esophageal implant device  205  might not include a separating wall  225 . Accordingly, the entire or substantially entire esophageal implant device  205  may be filled with the filling  210 . 
     As shown above, for example in  FIG. 2A , the esophageal implant device  205  may be fixed to the patient&#39;s esophageal lumen via a tissue fixation means  215 . 
       FIG. 2D  illustrates one embodiment of a tissue fixation means, and in particular, a mesh tissue anchor  250 . The mesh tissue anchor  250  may be fully collapsible to allow delivery via endoscopic instrumentation (e.g., a needle driver). After penetration through the mucosal-serosal tissue  201 , the mesh tissue anchor  250  may expand to prevent immediate retraction back within the esophageal lumen. 
     More particularly, the mesh tissue anchor  250  may include a pin  251  and a collapsible pin anchor  255 . The pin  251  may include a head portion  252  connected to a stem portion  253 , which in turn is connected to an anchor interface  254  connected to the collapsible pin anchor  255 . When collapsed, the collapsible pin anchor  255  may be configured to be smaller than the holes  220  such that the collapsible pin anchor  255  may be insertable into any one of the holes  220 . The stem portion  253  may be substantially the same dimension or slightly smaller as any of the holes  220  to allow the stem portion  253  to engage and hold the pin  251  in place after the collapsible pin anchor  255  is inserted through any one of the holes  220 . The head portion  252  may be configured to be larger than the holes  220  to prevent the pin  251  from slipping through the holes  220 . After the collapsible pin anchor  255  pierces through the mucosal-serosal tissue  201 , the collapsible pin anchor  255  may be expanded dimensionally to prevent the aforementioned retraction. In this manner, the mesh tissue anchor  250  fixes the esophageal implant device  205  to the patient&#39;s mucosal-serosal tissue  201 . 
       FIG. 2E  illustrates the mesh tissue anchor  250  outside the patient&#39;s body for clarity. As shown here, the mesh tissue anchor  250  is in its expanded orientation. While not shown, the mesh tissue anchor  250  may also be collapsed in another orientation. In one embodiment, generally-speaking, the mesh tissue anchor  250  may be loosely analogous to the operation of an umbrella operable to be collapsed or expanded. The collapsible pin anchor  255  may include a supporting portion  256  designed to be smooth and flat and for contacting an outside surface of the patient&#39;s serosal tissue when the collapsible pin anchor  255  is expanded. The collapsible pin anchor  255  may further include an apex  257  for holding the pin  251  to the collapsible pin anchor  255 . 
     In one embodiment, when expanded and positioned as shown in  FIG. 2D , the collapsible pin anchor  255  may allow for tissue in-growth thereby providing even greater fixating potential and biocompatibility. In addition, discrete anchor implantation and/or removal may be performed by endoscopy. 
       FIG. 2F-2H  illustrates another example of a tissue fixation means. Here, tissue fixation may be accomplished using a combination of anchors that mate with a gastric band that wraps around the exterior of the patient&#39;s esophagus. The gastric band may be advantageous due to the proven longevity of the support (e.g., over 10 years) and further promoting satiety by providing a presence about the surrounding satiety nerves. Implantation and removal of this embodiment of fixation may be performed laparoscopically. 
       FIG. 2F  illustrates one embodiment of how the esophageal implant device  205  may be attached to the patient&#39;s mucosal-serosal tissue  201  via anchors  270  and further holding the gastric band  275  in place. 
     More particularly, as shown in  FIG. 2G , a plurality of anchors  270  may be positioned circumferentially and uniformly about the patient&#39;s esophagus. The anchors  270  advantageously hold the esophageal implant device  205  in place while also functioning similarly to belt loops creating a barrier against undesired movement in three directions with respect to the gastric band  275 , thereby holding the gastric band  275  in place contacting the patient&#39;s esophagus. 
       FIG. 2H  illustrates how the anchors  270  are placed into position. The anchors  270  may include a pin component  276  having a stem portion  277  and a head portion  278 , and a hook component  279 . The stem portion  277  of the pin component  276  may penetrate holes  220  of the esophageal implant device  205  and mucosal-serosal tissue  201  prior to being received and joined to the hook component  279 . In this manner, the anchors  270  function to hold in place the esophageal implant device  205  on the mucosal side of the mucosal-serosal tissue  201  and the gastric band  275  on the serosal side the mucosal-serosal tissue  201 . 
       FIGS. 3A-3E  illustrates another embodiment of an esophageal implant device  300 . The esophageal implant device  300  may be compliant, low-durometer (e.g., 0-30 Shore A), and low viscosity fluid filled. As shown, substantially the entire interior of the esophageal implant device  300  may be filled with a low viscosity fluid. For example, low viscosity fluids may include saline, silicone or other substances. Similar to the esophageal implant device  200  of  FIG. 2A , the esophageal implant device  300  may emulate natural tissue behavior. However, the esophageal implant device  300  may further self-regulate internal pressures when implanted within the patient&#39;s esophagus  301 . Furthermore, a “gating” effect may cause the bolus of food  350  traveling in the direction of arrow  310  to be further broken down as a result of the pressures on the esophagus  301 . 
       FIGS. 3B-3E  illustrate how the esophageal implant device  300  may function. As shown in  FIG. 3B , when the bolus of food  350  reaches the esophageal implant device  300  in the direction of arrows  310 , the body  305  of the esophageal implant device  300  is in an equilibrium state. 
     However, as the bolus of food  350  begins to transport through the esophageal implant device  300  as illustrated in  FIG. 3C , the bolus of food  300  begins to exert a pressure causing the fluid within the esophageal implant device  300  to move in the direction of arrows  315 . Here, the bolus  350  also applies an outward pressure and gates off the bottom portion of the esophageal implant device  300  (via the bulge beneath arrows  315 ) reservoir thereby slowing the digestion process and helping the patient feel satiated for a longer period of time. 
     As the bolus of food  350  continues to move downward in the direction of arrow  310 , proximal to the middle portion of the esophageal implant device  300 , the pressure exerted on the esophageal implant device  300  now causes some fluid to move in the direction of arrows  315  and some fluid to move in the direction of arrows  320 , thereby facilitating the move of the bolus  350  downwards while also applying an outward pressure on the esophagus  301 . 
     As peristalsis further transports the bolus of food  350  downward, proximal to the bottom portion of the esophageal implant device  300 , the bolus of food  350  now exerts a pressure causing the fluid within the esophageal implant device  300  to move upwards in the direction of arrows  320 . 
     As shown, the top portions of the esophageal implant device  300  above the arrows  320  bulges inward due to the influx of fluid thereby resulting in a gating effect. That is, the influx of fluid moving to the top portion of the esophageal implant device  300  above the arrows  320  momentarily prevents any other bolus from passing through the esophageal implant device  300 . 
     Satiety may be correlated with bolus activity about the gastric band (e.g., moving up and back down), and therefore, in the manner illustrated in  FIGS. 3B-3E , the patient may experience improved satiety after swallowing a bolus of food. In addition, the gating effect may assist to guide the bolus  350  through the esophageal implant device  300 . 
     Other embodiments of an endoscopic device for the treatment of obesity may include a variable-sized opening for the passage of a bolus of food. 
     For example, a mechanical stoma may be provided. Due to the presence of mechanics, the relative ability for the mechanical stoma to emulate natural tissue motions may be less than the endoscopic devices  200  and  300  but still remain non-stiff. 
       FIGS. 4A-4D  illustrate one embodiment of the mechanical stoma in the form of a conical valve  405 . The conical valve  405  allows for regulating control over the overall restrictive capability of the esophageal implant  400 . The restriction adjustment is based on the relative separation between the conical valve  405  and the housing  410 . That is, the greater the separation, the less restriction the esophageal implant  400  can maintain. In one embodiment, the esophageal implant  400  may be physician adjusted. 
     As shown in  FIG. 4A , the conical valve  405  is completely inserted into the housing  410 , and as a result, the esophageal implant  400  is relatively very restrictive in this orientation. 
     Conversely, as shown in  FIG. 4B , the conical valve  405  is not fully inserted into the housing  410 , and as a result, the esophageal implant  400  is not as restrictive in this orientation as compared to the orientation of  FIG. 4A . The arrow  420  illustrates a direction that the conical valve  405  may be manipulated to cause the esophageal implant  400  to be more restrictive. Conversely, manipulating the conical valve in the reverse direction may cause the esophageal implant  400  to be less restrictive. 
       FIGS. 4C and 4D  illustrate a top view and a bottom view, respectively, of the esophageal implant  400  showing the gaps where the food may pass through between the conical valve  405  and the housing  410 . As the conical valve  405  is manipulated to be increasingly restrictive, the gaps where the food may pass through become decreasingly smaller. In this manner, the conical valve  405  may be manipulated to control the level of restriction. 
     Manipulation of the conical valve  405  may be performed by the physician via a mechanical interface (e.g., a screw, spring or friction). Alternatively, the conical valve  405  may include a motor controllable by a remote computing device outside the body. 
       FIGS. 5A and 5B  illustrate another embodiment of a mechanical stoma  500 , here shown to include a plurality of plates  505  which pivot and/or overlap to vary the opening for the bolus of food. 
       FIG. 5A  is a top view of the mechanical stoma  500  having a plurality of plates  505  attached to a body  510  via pivoting member  515 . The plates  505  may be pivotably fixed to the body  510  to create a variably-sized opening for the passage of a bolus of food. As shown, the plates  505  are positioned in a relatively “closed” orientation resulting in a relatively small opening. 
     In one embodiment, the plates  505  may further engage one another such that movement of one plate may trigger the movement of an adjacent plate. Alternatively, the plates  505  might not contact each other and may be controlled independently. The physician may control the positioning of the plates  505  manually via an endoscopic device or the plates  505  may include a motor controllable by a remote computing device outside the body. 
       FIG. 5B  illustrates a top view of the mechanical stoma  500  having the plurality of plates  500  positioned in a relatively “open” orientation resulting in a relatively large opening for the passage of food. 
     In another embodiment, an endoscopic device having a variably sized opening or iris may be provided to restrict a patient&#39;s consumption of food. For example,  FIG. 6A  illustrates a top view of an endoscopic device  600  defining an opening  605  for the passage of a bolus of food. In one embodiment, the endoscopic device  600  may be a biocompatible diaphragm  610  stretched across a frame  615 , which may be rigid. The frame  615  may be attached to a patient&#39;s esophageal-gastric junction via tissue fixation means (e.g., as described herein).  FIG. 6B  illustrates a cross-sectional side view of the biocompatible diaphragm  610  fixed across the frame  615 . 
       FIG. 6C  illustrates the operation of the endoscopic device  600  with respect to a bolus of food  670 . As the bolus of food  670  swallowed by the patient reaches the biocompatible diaphragm  610 , the bolus of food  670  may cause a downward pressure on the opening  605  of the diaphragm  610  thereby temporarily enlarging the opening  605  and allowing the bolus of food  670  to pass through.  FIG. 6D  illustrates how the opening  605  of the endoscopic device  600  stretches to accommodate the bolus of food  670 . The biocompatible diaphragm  610  as shown, defines one opening  605 , but in other embodiments, may include additional openings of varying or uniform sizes. 
     The physician may be able to adjust the endoscopic device  600  in any of a plurality of ways to customize the size, shape and firmness of the diaphragm  600 . For example, the physician may cut the opening  605  to size endoscopically or prior to implantation. The physician may also configure how taut the diaphragm  600  is when fixed to the frame  615  thereby controlling the size and/or shape of the opening  605 , and further controlling the material&#39;s ability to stretch. In one or more embodiments, the material of the diaphragm (e.g., rubber) itself may be configured to be stiffer or more compliant as desired by the physician. 
       FIG. 7  illustrates a top view of an endoscopic device  700  having a “cross-hair shaped”, variably sized opening  705  defined by a diaphragm  710 , which may be stretched and/or fixed to a frame  715  according to an embodiment of the present invention. The endoscopic device  700  may operate and/or be configured similarly to endoscopic device  600  of  FIG. 6A . Assuming all else equal, such a shaped opening may allow for better control of bolus transport through the device than the iris-shaped opening of  FIG. 6A . 
       FIG. 8  illustrates a top view of an endoscopic device  800  having an ellipsoid-shaped, variably sized opening  805  defined by a diaphragm  810 , which may be stretched and/or fixed to a frame  815  according to an embodiment of the present invention. The endoscopic device  800  may operate and/or be configured similarly to endoscopic device  600  of  FIG. 6A . Assuming all else equal, the ellipsoid-shaped opening  805  may allow for easier passage of fluids due to being larger than the opening  605  of  FIG. 6A . However, the configuration, and namely because the opening  805  is more narrow than the opening  605  of  FIG. 6A , the passage of larger boluses of food may be more restricted with respect to the endoscopic device  800 . 
     In certain embodiments, esophageal implants may include artificial esophageal stomas and stents or stent-like fixation means. Using such artificial stomas may provide substantial advantages including, but not limited to, (1) providing a noninvasive, non-surgical alternative to existing obesity treatment devices, (2) including stent or stent-like portions for positioning and fixating means to hold the artificial stoma in place, (3) providing non-invasive means for determining implant location within a patient&#39;s body due to being visible under fluoroscopy or other radiographic imagining, (4) having pliable and complaint characteristics making the artificial esophageal stoma obstruction tolerant, (5) allowing variability in the size of the stoma/stent (e.g., by removing a stoma/stent of one size and replacing it with a stoma/stent of a second size), and/or (6) allowing removal of the artificial esophageal stoma using non-surgical, full endoscopic instrumentation. 
       FIG. 9A  illustrates one embodiment of an esophageal implant  900  positioned within a patient&#39;s esophagus  905 . The esophageal implant  900  may include a stent portion  910  and an artificial stoma portion  915 . 
     The esophageal implant  900  is shown outside the patient&#39;s body for clarity in  FIG. 9B . The stent portion  910  may be constructed out of nitinol, nitinol-platinum alloys or other materials with similar properties and may be configured to have any of a number of different geometries to assist with fixation and migration resistance when implanted into the esophagus  905 . The stent portion  910  may also include barbs, ribs, fins, struts or other outward members to further prevent migration and maintain fixation within the patient&#39;s esophagus  905 . In addition, the stent portion  910  may be coupled with tissue fixation means (e.g., such as mesh anchor  250 ). 
     The stent portion  910  may be attached to the artificial stoma portion  915  via a lining portion  925 . The lining portion  925  may be constructed out of silicone and may cover the stent portion  910  partially (as shown) or entirely (not shown). The lining portion  925  may be attached to the stent portion  910  and the artificial stoma portion  915  via any one of a number of different techniques including but not limited to (1) situating the lining portion  925  along the inner diameter of the stent portion  910  (e.g., in a “belt-and suspenders” type design), (2) overmolding the stoma shell over the stent and then filling the shell with gel, and/or (3) utilizing mechanical fixation means or other appropriate fixation means. 
     The artificial stoma portion  915  may be gel-filled and both pliable and compliant. For example, the artificial stoma portion  915  may operate in a manner similar to endoscopic devices  200  and  300  of  FIGS. 2A and 3A , respectively. 
     The esophageal implant  900  may also include grasping members  920  fixed to the top of the stent portion  910  as shown in  FIGS. 5B and 5C  for easier implantation and/or removal. Alternatively and/or in addition, a suture running through the stent portion  910  may assist to collapse the esophageal implant  900  for removal. 
     In one or more embodiments, the esophageal implant  900  may act as a “funnel” such that the opening  935  at the top of the stent portion  910  may be larger than the opening  930  at the bottom of the artificial stoma portion  915  to guide a bolus of food and to provide the restrictive features of the artificial stoma portion  915 . 
     Many variations to the esophageal implant  900  may be possible. For example, the artificial stoma portion  915  may be endoscopically removed leaving the stent portion  910  in place. In this manner, removal of the restrictive stoma portion  910  may be performed while enabling future reattachment of a similarly sized or differently sized stoma portion. 
     Other variations to the esophageal implant  900  may include changing the conical geometry to a cylindrical geometry over varied lengths, including flared ends or including ribs, fins or other barb-like features along the stent body to assist with fixation within the esophageal lumen and to prevent migration during normal and/or increased peristalsis. The stent portion  910  may also be braided or laser cut to improve the collapsibility of the esophageal implant  900  for delivery, opening force and compliance within the patient&#39;s body. 
       FIG. 9D  is a close-up view of  FIG. 9A  showing the endoscopic device having the stent portion  910  located above the artificial stoma portion  915  (i.e., the artificial stoma portion  915  being distal to the stent portion  910 ). 
     However, alternative embodiments as shown in  FIGS. 10 and 11  may include endoscopic devices  1000  and  1100  where the artificial stoma portion is located above the stent portion (as shown in  FIG. 10  wherein the artificial stoma portion  1015  being proximal to the stent portion  1010 ) or contained within the stent portion (as shown in  FIG. 11  wherein the stoma portion is integrated within the stent portion  1110  effectively reducing longitudinal contact on the mucosal tissue). 
     Certain embodiments have been disclosed to clarify the concepts including the above structural configurations. However, one skilled in the art will recognize that an endless number of implementations may be performed with the concepts herein. For example, the tube may be a catheter and may be used in other applications which require transferring fluid or gas. 
     Unless otherwise indicated, all numbers expressing quantities of ingredients, volumes of fluids, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
     The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
     Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
     Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. 
     Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety. 
     Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. 
     In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.

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