Abstract:
A system and method forms a gastric reduction pouch within a stomach associated with an esophagus. The method includes the steps of delivering, down the esophagus, a substantially planar annular member into the stomach, drawing stomach wall tissue to a juxtaposed relation with the annular member; and securing, to the annular member, the stomach wall tissue juxtaposed to the annular member.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention is generally directed to a therapy for treating obesity. The present invention is more particularly directed to a transesophageal gastric reduction method and device for performing gastric reduction surgery while minimizing surgical invasion. 
       BACKGROUND OF THE INVENTION 
       [0002]    Obesity is a complex chronic disease involving environment, genetic, physiologic, metabolic, behavioral and psychological components. It is the second leading cause of preventable death in the United States. 
         [0003]    Obesity affects nearly one-third of the adult American population (approximately 60 million). The number of overweight and obese Americans has continued to increase since 1960. The trend is not slowing down. Today, 64.5% of adult Americans are categorized as being overweight or obese. Each year, obesity causes at least 300,000 excess deaths in the United States, and healthcare costs of American adults with obesity amounted to approximately $100,000,000,000 (100 billion dollars). 
         [0004]    Obesity is not limited to the United States but is increasing worldwide. It is increasing worldwide in both developing and developed countries and is thought to be caused by environmental and behavioral changes resulting from economic development, modernization, and urbanization. Obesity is increasing in children as well. It is believed that the true health consequences of obesity have not yet become totally apparent. 
         [0005]    Obesity is currently treated by dietary therapy, physical activity, behavioral therapy, drug therapy, and combinations thereof. Dietary therapy involves instruction on how to adjust a diet to reduce the number of calories eaten. Physical activity strategies include use of aerobic exercise, brisk walking, jogging, cycling, and swimming. Behavioral therapy involves changing diet and physical activity patterns and habits to new behaviors that promote weight loss. Drug therapy is most often used only in conjunction with appropriate lifestyle modifications. 
         [0006]    One last treatment for obesity is surgery. Surgery is a treatment option which is generally reserved for persons with severe obesity and those who are morbidly obese. In addition, surgery is not generally performed until other methods of weight loss have been attempted and have been found to be ineffective. Persons who are severely obese are generally unable to physically perform routine daily activities, whether work-related or family functions and have a severely impaired quality of life due to the severity of their obesity. 
         [0007]    Most obesity surgeries involve making changes to the stomach and/or small intestines. Currently, there are two types of obesity surgery: (1) restrictive; and (2) combined restrictive and malabsorptive. Operative procedures have been developed for each type of surgery. Each type of surgery has its own risks and side effects. 
         [0008]    In restrictive surgery, bands or staples are used to create food intake restriction. The bands or staples are surgically placed near the top of the stomach to section off a portion that is often called a stomach pouch. A small outlet, about the size of a pencil eraser, is left at the bottom of the stomach pouch. Since the outlet is small, food stays in the pouch longer and the feeling of fullness lasts for a longer time. Current operative procedures for restrictive surgery include vertical banded gastroplasty, gastric banding, and laparoscopic adjustable gastric banding. In vertical banded gastroplasty, a stomach pouch is surgically created. In gastric banding, a band is used to create the stomach pouch. In laparoscopic adjustable gastric banding, a less invasive procedure, smaller incisions are made to apply the band. The band is inflatable and may be adjusted over time. 
         [0009]    Each of the foregoing therapies for severe obesity has its risks and side effects. Each is invasive surgery and hence exhibits the risks commonly associated with all surgical procedures. Complications may include leaking of stomach juices into the abdomen, injury to the spleen, band slippage, erosion of the stomach by the band, breakdown of the staple line, and stomach pouch stretching from overeating. 
         [0010]    However, reductive surgery has proven successful. About 80% of patients lose some weight and 30% reach a normal weight. Hence, the benefits of gastric reduction surgery are generally believed to outweigh the attendant risks and potential complications. 
         [0011]    The present invention is directed to an alternative method and device for achieving gastric reduction. As will be seen hereinafter, the method does not require surgical incisions and is thus less invasive than previous reduction therapies. 
       SUMMARY OF THE INVENTION 
       [0012]    The invention provides a method of forming a gastric reduction pouch within a stomach associated with an esophagus. The method comprises the steps of delivering, down the esophagus, a substantially planar annular member into the stomach, drawing stomach wall tissue to a juxtaposed relation with the annular member, and securing, to the annular member, the stomach wall tissue juxtaposed to the annular member. 
         [0013]    The step of securing may include deploying a plurality of fasteners about the annular member. The step of drawing may include forming a fold of stomach tissue juxtaposed to and about the annular member. The step of securing may more particularly include deploying a plurality of fasteners about the annular member to fasten the tissue folds to the annular member. The fold of stomach tissue may be formed oral of the annular member or aboral of the annular member. 
         [0014]    The method may further comprise the step of adjusting the circumference of the annular member. The annular member may be star shaped or ring shaped. 
         [0015]    The annular member includes a passageway having a size, and the method may further comprise adjusting the size of the passageway. The size of the passageway may be adjusted by inserting a hollow bushing into the annular member passageway. The step of drawing stomach wall tissue to a juxtaposed relation with the annular member may comprise pulling a vacuum in the stomach. 
         [0016]    The invention further provides a system for forming a gastric reduction pouch within a stomach associated with an esophagus comprising an annular member and a device that delivers the annular member into the stomach from the esophagus, draws stomach wall tissue to a juxtaposed relation with the annular member, and that secures the juxtaposed stomach wall tissue to the annular member. 
         [0017]    In one embodiment, the system comprises a piston member having a distal end and being arranged to be passed down the esophagus to place the distal end within the stomach. The system further comprises an elongated member slidingly arranged on the piston member. The elongated member has a cross-sectional dimension greater than the piston member to form a movable annular support surface. The elongated member further comprises a plurality of fastener deployment channels communicating with the annular support surface. The system further comprises an annular member carried on the piston member adjacent the movable annular support surface, a tissue grabber that grabs stomach tissue and disposes the grabbed stomach tissue between the annular member and the movable annular support surface, and a plurality of fasteners deployable through the fastener deployment channels. 
         [0018]    With stomach tissue disposed between the annular member and the movable annular support surface to form a fold of stomach tissue about the piston member between the annular member and the movable annular support surface, the plurality of fasteners may be deployed through the fastener deployment channels to secure the stomach tissue fold to the annular member about the piston member to form the gastric reduction pouch within the stomach. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein: 
           [0020]      FIG. 1  is a front cross-sectional view of the esophageal-gastro-intestinal tract from a lower portion of the esophagus to the duodenum; 
           [0021]      FIG. 2  is a front cross-sectional view with portions cut away illustrating a device according to an embodiment of the invention after being deployed by a method according to one embodiment of the invention and forming a gastric reduction pouch; 
           [0022]      FIG. 3  is a front cross-sectional view with portions cut away illustrating another device according to an embodiment of the invention after being deployed and forming a gastric reduction pouch; 
           [0023]      FIG. 4  is a front cross-sectional view with portions cut away illustrating the device of  FIG. 2  after being deployed by a method according to another embodiment of the invention and forming a gastric reduction pouch; 
           [0024]      FIG. 5  is a front cross-sectional view with portions cut away illustrating another device according to an embodiment of the invention after being deployed and forming a gastric reduction pouch; 
           [0025]      FIG. 6  is a side plan view illustrating a system for forming a gastric reduction pouch according to the embodiment illustrated in  FIG. 4 ; 
           [0026]      FIG. 7  is a side plan view, to an enlarged scale, of a distal portion of the system of  FIG. 6 ; 
           [0027]      FIG. 8  is a side plan view illustrating an initial step in the use of the system of  FIG. 6  in forming a gastric reduction pouch according to an embodiment of the invention; 
           [0028]      FIG. 9  is a side plan view illustrating a further step in the use of the system of  FIG. 6 ; 
           [0029]      FIG. 10  is a side plan view illustrating a further step in the use of the system of  FIG. 8  wherein the stomach is evacuated to draw the stomach wall to the system; 
           [0030]      FIG. 11  is a side plan view illustrating a further step in the use of the system of  FIG. 8  wherein the system is folding the stomach wall in juxtaposed relation to a device for maintaining a gastric reduction pouch according to this embodiment of the invention; 
           [0031]      FIG. 12  is a side plan view illustrating a still further step in the use of the system of  FIG. 8  wherein the system is compacting the fold in the stomach wall juxtaposed to the device for maintaining a gastric reduction pouch according to this embodiment of the invention; 
           [0032]      FIG. 13  is a side plan view illustrating a still further step in the use of the system of  FIG. 8  wherein the system has secured the folded stomach wall to the device for maintaining a gastric reduction pouch according to this embodiment of the invention; 
           [0033]      FIG. 14  is a side plan view illustrating a still further step in the use of the system of  FIG. 8  wherein the system is being separated from the device for maintaining a gastric reduction pouch according to this embodiment of the invention; 
           [0034]      FIG. 15  is a side plan view of a gastric reduction pouch formed by the system of  FIG. 8  being maintained by the device for maintaining the gastric reduction pouch according to this embodiment of the invention; 
           [0035]      FIG. 16  is a side view with portions cut away illustrating another system for forming a gastric reduction pouch according to another embodiment of the present invention; 
           [0036]      FIG. 17  is a side view with portions cut away illustrating the system of  FIG. 16  at an intermediate stage for forming a gastric reduction pouch according to this embodiment of the present invention; 
           [0037]      FIG. 18  is a side view with portions cut away illustrating the system of  FIG. 16  at a further stage in forming a gastric reduction pouch according to this embodiment of the present invention; 
           [0038]      FIG. 19  is a side view with portions cut away illustrating the device deployed by the system of  FIGS. 16-18  and the gastric reduction pouch thus formed; and 
           [0039]      FIG. 20  is a side view illustrating a manner in which a stomach formed according to the invention may be reduced in size. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0040]      FIG. 1  is a front cross-sectional view of the esophageal-gastro-intestinal tract  40  from a lower portion of the esophagus  41  to the duodenum  42 . The stomach  43  is characterized by the greater curvature  44  on the anatomical left side and the lesser curvature  45  on the anatomical right side. The tissue of the outer surfaces of those curvatures is referred to in the art as serosa tissue. As will be seen subsequently, the nature of the serosa tissue is used to advantage for its ability to bond to like serosa tissue. The fundus  46  of the greater curvature  44  forms the superior portion of the stomach  43 , and traps gas and air bubbles for burping. The esophageal tract  41  enters the stomach  43  at an esophageal orifice  58  below the superior portion of the fundus  46 , forming a cardiac notch  47  and an acute angle with respect to the fundus  46  known as the Angle of His  57 . The lower esophageal sphincter (LES)  48  is a discriminating sphincter able to distinguish between burping gas, liquids, and solids, and works in conjunction with the fundus  46  to burp. The gastroesophageal flap valve (GEFV)  49  includes a moveable portion and an opposing more stationary portion. The moveable portion of the GEFV  49  is an approximately 180 degree, semicircular, gastroesophageal flap  50  (alternatively referred to as a “normal moveable flap” or “moveable flap”) formed of tissue at the intersection between the esophagus  41  and the stomach  43 . The opposing more stationary portion of the GEFV  49  comprises a portion of the lesser curvature  45  of the stomach  43  adjacent to its junction with the esophagus  41 . The gastroesophageal flap  50  of the GEFV  49  principally comprises tissue adjacent to the fundus  46  portion of the stomach  43 , is about 4 to 5 cm long ( 51 ) at its longest portion, and the length may taper at its anterior and posterior ends. The gastroesophageal flap  50  is partially held against the lesser curvature  45  portion of the stomach  43  by the pressure differential between the stomach  43  and the thorax, and partially by the resiliency and the anatomical structure of the GEFV  49 , thus providing the valving function. The GEFV  49  is similar to a flutter valve, with the gastroesophageal flap  50  being flexible and closeable against the other more stationary side. 
         [0041]    The esophageal tract is controlled by an upper esophageal sphincter (UES) near the mouth for swallowing, and by the LES  48  and the GEFV  49  at the stomach. The normal anti-reflux barrier is primarily formed by the LES  48  and the GEFV  49  acting in concert to allow food and liquid to enter the stomach, and to considerably resist reflux of stomach contents into the esophagus  48  past the gastroesophageal tissue junction  52 . Tissue aboral of the gastroesophageal tissue junction  52  is generally considered part of the stomach because the tissue protected from stomach acid by its own protective mechanisms. Tissue oral of the gastroesophageal junction  52  is generally considered part of the esophagus and it is not protected from injury by prolonged exposure to stomach acid. At the gastroesophageal junction  52 , the juncture of the stomach and esophageal tissues form a zigzag line, which is sometimes referred to as the “Z-line.” For the purposes of these specifications, including the claims, “stomach” means the tissue aboral of the gastroesophageal junction  52 . 
         [0042]      FIGS. 2-4  show various embodiments of gastric reduction according to the present invention. In  FIG. 2 , it may be noted that a reduced diameter portion  100  of a stomach  43  is formed in accordance with an embodiment of the present invention to result in a gastric reduction pouch  110 . The gastric reduction pouch  110  is formed by a fold  102  made circumferentially about the stomach  43  aboral of the Z line  52 . The fold  102  is formed by circumferentially gathering the stomach tissue in juxtaposed relation to a major surface  104  of an annular member  106 . The annular member  106  is secured to the fold  102  of stomach tissue by a plurality of fasteners  108  that extend through the surface  104  of the annular member  106  and both tissue layers of the fold  102  about the annular member  106 . 
         [0043]    The annular member  106  may be ring shaped as shown. This provides an opening  107  through which food may pass from the pouch  110  to the rest of the stomach. 
         [0044]    The annular member  106  may be formed of most any biocompatible substantially non-elastic material that will maintain its shape. Such materials may include, for example, titanium, Nitinol, silicone rubber, biocompatible plastics, and fabric meshes, of the type and compositions known in the art. 
         [0045]    The fasteners may be of the type described in co-pending application Ser. No. 11/121,697, filed Jan. 25, 2005 titled SLITTED TISSUE FIXATION DEVICE AND ASSEMBLIES FOR DEPLOYING THE SAME which application is incorporated herein in its entirety. As may be appreciated, other fasteners and fastener assemblies may be used in securing the stomach tissue fold  102  to the annular member  106  without departing from the present invention. When the annular member is formed of a material that may be pierced by a stylet, the fasteners may be deployed through the annular material. However, if the annular member is formed of a material that may not be pierced by a stylet, apertures may be provided within the major surface  104  through which the fasteners may be deployed. 
         [0046]    Referring now to  FIG. 3 , it shows a similar annular device  126  for maintaining a gastric reduction pouch  110  formed in a stomach  43 . As in the previous embodiment, the gastric reduction pouch  110  is formed by a fold  102  made circumferentially about the stomach  43  aboral of the Z line  52 . Also as in the previous embodiment, the fold  102  is formed by circumferentially gathering the stomach tissue in juxtaposed relation to a major surface  124  of the annular member  126 . The annular member  126  is secured to the fold  102  of stomach tissue by a plurality of fasteners  108  that extend through the surface  104  of the annular member  106  and both tissue layers of the fold  102  about the annular member  106 . 
         [0047]    The annular member  126  is ring shaped as shown. This provides an opening  127  through which food may pass from the pouch  110  to the rest of the stomach. 
         [0048]    The annular member  126  may be seen to further include an adjustment mechanism  130  which may be employed to adjust the size or circumference of the annular member  126 . The adjustment mechanism includes a chain  132  which is weaved in and out through the annular member  126  about its circumference, much like a purse string. The chain  132 , at one end, includes a series of spaced apart bumps  133 , and at the other end, a locking clasp  134 . As the chain  132  is pulled through the clasp  134 , the circumference of the annular member is made smaller. The co-action of the bumps  133  and clasp  134  maintain the circumference to a desired length. To permit this operation, the annular member  126  must be formed of a substantially flexible material such as, for example, silicone rubber or a fabric mesh. 
         [0049]      FIG. 4  shows an embodiment where the annular member  106  is positioned on the aboral side of the stomach tissue fold  102 . This may be preferable from the standpoint that food passing from the gastric reduction pouch into the rest of the stomach  43  is shielded from the annular member  106  by the fold  102  so that it may be less likely for the food to get caught on the annular member  106 . A procedure for positioning the annular member  106  as shown in  FIG. 4  is described in detail herein after. 
         [0050]      FIG. 5  shows a further embodiment of the invention. Here, the annular member  140  has a sinusoidal star-shaped configuration. This wavy shape of the member  140  serves to increase radial compliance for passing a large bolus of food from the gastric reduction pouch  110  into the rest of the stomach  43 . This would even result if the material forming the member  140  is relatively non-compliant. The member may be formed from material such as polypropylene, EPTFE, or PVDF, for example. A plurality of fasteners  108  secure the stomach tissue fold  102  to the annular member  140 . 
         [0051]    Referring now to  FIG. 6 , it show a system  200  for forming a gastric reduction pouch in a manner embodying the present invention. The system  200  includes an annular member  206  and a device  202  that draws stomach tissue to the annular member  206  and secures the drawn stomach tissue to the annular member to form a gastric reduction pouch. The device  202  includes an elongated member  204  and an inner sleeve or piston  212 . The elongated member is flexible and dimensioned for being fed down an esophagus and into a stomach wherein the gastric reduction pouch is to be formed. The elongated member  204  includes a solid end portion  210  that terminated in a moveable annular support surface  211  at its distal end  208 . It also has a central lumen  214 , a plurality of fastener guide channels  216 , and a plurality of vacuum ports  218 . The central lumen  214  is dimensioned to slidingly receive the piston  212 . 
         [0052]    The piston  212  includes a plurality of vacuum ports  220 . It also has a central lumen  222  dimensioned to slidingly receive an endoscope  224 . 
         [0053]      FIG. 7  shows details of the connection between the piston  212  and the annular member  206 . As may be noted, the piston  212  terminates in an annular flange  226  which is received within an annular grove  228  of the annular member. Like the elongated member  204 , the piston  212  is formed of flexible material. As a result, the annular flange  226  may be pulled out of the annular groove  228  to separate the annular member  206  from the piston  212  after the gastric reduction pouch has been formed. 
         [0054]      FIG. 8  shows a first step in a procedure for forming a gastric reduction pouch with the system  200  of  FIG. 6  according to one embodiment of the invention. Here it may be seen that the elongated member  204  has been fed down the esophagus  41  and into the stomach  43 . The endoscope  224  has been advanced through the device and into the stomach  43  to enable visualization. 
         [0055]    In the next step of  FIG. 9 , a vacuum is pulled through the vacuum ports  218  of the elongated member  204 . This causes the esophageal wall to be drawn to the elongated member to provide a seal between the esophagus  41  and the elongated  204 . In some cases, this step may not be necessary, and hence elective. 
         [0056]    In the next step shown in  FIG. 10 , a vacuum is pulled through a working channel  226  of the endoscope  224  This causes the wall of the stomach to be drawn to the device and sealed against at least the distal portion  208  of the elongated member  204  and the annular member  206  carried by the sleeve 
         [0057]    Next, as shown in  FIG. 11 , a vacuum is drawn through the vacuum ports  220  of the piston  212  to cause the wall of the stomach to be drawn in between the annular surface  211  and the annular member  206 . As will be noted, this causes the stomach wall to be folded inwardly to create a fold  102 . Then, as shown in  FIG. 12 , the piston  212  is moved relative to the elongated member  204  to cause the fold to be squeezed or flattened between the annular member  206  and the distal end portion  208  of the elongated member  204 . Hence, the vacuum ports  220  have grasped the stomach tissue and folded it in juxtaposed relation to the major surface  207  of the annular member  206 . 
         [0058]    The annular member  206  and the stomach tissue fold  102  are now ready to be secured together. To that end, as shown in  FIG. 13 , a plurality of fasteners  108  may be advanced down the guide channels  216  and deployed through openings  209  of the annular member  206 . This may be implemented as described, for example, in the prior referenced application Ser. No. 11/121,697. 
         [0059]    With the stomach tissue fold  102  secured to the annular member  206 , the annular member  206  and sleeve  212  are now ready to be separated. This may be accomplished as previously described by the piston  212  being moved relative to the elongated member  204  and thus the annular member  206 . The vacuum seals may now be released and the elongated member  204  pulled upward and out through the esophagus.  FIG. 14  shows this step being performed. 
         [0060]    When the device is fully removed, or as the device is being removed, the stomach may be inflated to assume its new anatomical configuration as shown, for example, in  FIG. 15 . Here it may be seen that a gastric reduction pouch  110  has been formed in stomach  43 . The opening  205  through the annular member  206  together with the fold  102  of stomach tissue define the opening of the gastric reduction pouch into the rest of the stomach  43 . As may be noticed, the annular member is disposed on the aboral side of the stomach tissue fold. 
         [0061]    Referring now to  FIG. 16 , it illustrates a system  300  for deploying an annular member  306  on the oral side of a tissue fold to form a gastric reduction pouch according to another embodiment of the invention. The system  300  generally includes an elongated member  302 , an inner tube  304 , and an endoscope  308 . 
         [0062]    At the distal end of the system  300 , the elongated member carries a first balloon  310  and the inner tube  304  carries a second balloon  312 . Intermediate the first and second balloons  310  and  312  is an annular member  306 . The first and second balloons  310  and  312  and the annular member  306  are disposed within the stomach  43  aboral of the Z line  52 . The endoscope extends down the inner tube and is retroflexed to provide visualization of the procedure. 
         [0063]    The system  300  further includes a fastener deploying device  320 . Here the fastener deploying device includes a guide tube that extends along side of the elongated member  302 . The fastener deploying divide further includes a stylet  324  the terminates in a sharpened tip  328  and a pusher  326  that pushes a fastener  108  to be deployed along the stylet  324  within the guide tube  322 . 
         [0064]    In a first stage of deploying the annular member  306 , the stomach  43  is evacuated by pulling a vacuum through, for example, a working channel of the endoscope  308 . The serves to collapse the tissue of the stomach about the system  300  within the stomach in close proximity to the balloons  310  and  312 . 
         [0065]    As may be seen in  FIG. 17 , the balloons  310  and  312  are inflated. The balloon  310  is generally spherical when inflated and the balloon  312  assumes a mushroom shape when inflated. The result of inflating the balloons  310  and  312  is to form a circumferential fold  402  of stomach about the inner tube  304  between the balloons  310  and  312 . The inflation of balloon  310  also causes the annular member  306  to open or spread into a substantially planar configuration between the balloon  310  and the tissue fold  402  and in juxtaposed relation to the tissue fold  402 . 
         [0066]    In a further step illustrated in  FIG. 18 , the fastener deploying device  320  deploys a plurality of fasteners  108  through the tissue fold  402  and the annular member  306 , one at a time. Once the fasteners are deployed, the balloons  310  and  312  are deflated. Once collapsed, the balloons  310  and  312  now permit the system  300  to be removed from the stomach  43 . During such removal, the second balloon  312  and the inner tube  304  pass through an opening  307  in the annular member  306 . The opening  307 , as in the previous embodiments permits food to pass to the remainder of the stomach  43  from the pouch  410  thus formed. 
         [0067]      FIG. 19  shows the annular member  306  and the formed gastric reduction pouch  410  after the system  300  has been removed from the stomach  43 . It may be noted that a reduced diameter portion  400  of a stomach  43  is formed in accordance with this embodiment of the present invention to result in the gastric reduction pouch  410 . The gastric reduction pouch  410  is formed by the fold  402  of stomach tissue made circumferentially about the stomach  43  aboral of the Z line  52 . The fold  402  is formed in juxtaposed relation to the annular member  306 . The annular member  306  is secured to the fold  402  of stomach tissue by a plurality of fasteners  108  that extend through the annular member  306  and both tissue layers of the fold  402  about the opening  307  of the annular member  306 . The annular member  306  is disposed on the oral side of the tissue fold  402 . 
         [0068]    Lastly,  FIG. 20  illustrates how the reduced diameter portion  102  of the stomach may be further reduced in size. Here it may be seen that hollow bushing  428  has been inserted into the annular member  106 . The bushing may be formed of silicon rubber, for example, to facilitate its being positioned on and within the annular member  106 . 
         [0069]    While particular embodiments of the present invention have been shown and described, modifications may be made, and it is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention.