Abstract:
A transoral gastroesophageal flap valve (GEFV) restoration device presents stomach tissue for fastening. The device comprises a longitudinal member having a portion arranged for transoral placement into a stomach. A tissue shaper is carried on the distal end of the longitudinal member that shapes stomach tissue within the stomach into a GEFV. The tissue shaper comprises a pair of hingedly coupled first and second arms for receiving the stomach tissue there between. The device further comprises a fastener director that directs a fastener into the stomach tissue along a path that is devoid of any deviations or bends greater than 45 degrees.

Description:
RELATED APPLICATION DATA  
       [0001]     The present patent application is a continuation-in-part application of U.S. patent application Ser. No. 11/235,668, filed Sep. 26, 2005. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention generally relates to manipulation of stomach tissue as by folding or molding and fastening to treat gastroesophageal reflux disease. The present invention more particularly relates to positioning tissue for fixation with devices in the stomach to promote reliable fixating of stomach tissue.  
       BACKGROUND  
       [0003]     Gastroesophageal reflux disease (GERD) is a chronic condition caused by the failure of the anti-reflux barrier located at the gastroesophageal junction to keep the contents of the stomach from splashing into the esophagus. The splashing is known as gastroesophageal reflux. The stomach acid is designed to digest meat, and will digest esophageal tissue when persistently splashed into the esophagus.  
         [0004]     A principal reason for regurgitation associated with GERD is the mechanical failure of a deteriorated gastroesophageal flap to close and seal against high pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap may deteriorate into a malfunctioning Grade III or absent valve Grade IV gastroesophageal flap. With a deteriorated gastroesophageal flap, the stomach contents are more likely to be regurgitated into the esophagus, the mouth, and even the lungs. The regurgitation is referred to as “heartburn” because the most common symptom is a burning discomfort in the chest under the breastbone. Burning discomfort in the chest and regurgitation (burping up) of sour-tasting gastric juice into the mouth are classic symptoms of gastroesophageal reflux disease (GERD). When stomach acid is regurgitated into the esophagus, it is usually cleared quickly by esophageal contractions. Heartburn (backwashing of stomach acid and bile onto the esophagus) results when stomach acid is frequently regurgitated into the esophagus and the esophageal wall is inflamed.  
         [0005]     Complications develop for some people who have GERD. Esophagitis (inflammation of the esophagus) with erosions and ulcerations (breaks in the lining of the esophagus) can occur from repeated and prolonged acid exposure. If these breaks are deep, bleeding or scarring of the esophagus with formation of a stricture (narrowing of the esophagus) can occur. If the esophagus narrows significantly, then food sticks in the esophagus and the symptom is known as dysphagia. GERD has been shown to be one of the most important risk factors for the development of esophageal adenocarcinoma. In a subset of people who have severe GERD, if acid exposure continues, the injured squamous lining is replaced by a precancerous lining (called Barrett&#39;s Esophagus) in which a cancerous esophageal adenocarcinoma can develop.  
         [0006]     Other complications of GERD may not appear to be related to esophageal disease at all. Some people with GERD may develop recurrent pneumonia (lung infection), asthma (wheezing), or a chronic cough from acid backing up into the esophagus and all the way up through the upper esophageal sphincter into the lungs. In many instances, this occurs at night, while the person is in a supine position and sleeping. Occasionally, a person with severe GERD will be awakened from sleep with a choking sensation. Hoarseness can also occur due to acid reaching the vocal cords, causing a chronic inflammation or injury.  
         [0007]     GERD never improves without intervention. Life style changes combined with both medical and surgical treatments exist for GERD. Medical therapies include antacids and proton pump inhibitors. However, the medical therapies only mask the reflux. Patients still get reflux and perhaps emphysema because of particles refluxed into the lungs. Barrett&#39;s esophagus results in about 10% of the GERD cases. The esophageal epithelium changes into tissue that tends to become cancerous from repeated acid washing despite the medication.  
         [0008]     Several open laparotomy and laparoscopic surgical procedures are available for treating GERD. One surgical approach is the Nissen fundoplication. The Nissen approach typically involves a 360-degree wrap of the fundus around the gastroesophageal junction. The procedure has a high incidence of postoperative complications. The Nissen approach creates a 360-degree moveable flap without a fixed portion. Hence, Nissen does not restore the normal movable flap. The patient cannot burp because the fundus was used to make the repair, and may frequently experience dysphagia. Another surgical approach to treating GERD is the Belsey Mark IV (Belsey) fundoplication. The Belsey procedure involves creating a valve by suturing a portion of the stomach to an anterior surface of the esophagus. It reduces some of the postoperative complications encountered with the Nissen fundoplication, but still does not restore the normal movable flap. None of these procedures fully restores the normal anatomical anatomy or produces a normally functioning gastroesophageal junction. Another surgical approach is the Hill repair. In the Hill repair, the gastroesophageal junction is anchored to the posterior abdominal areas, and a 180-degree valve is created by a system of sutures. The Hill procedure restores the moveable flap, the cardiac notch and the Angle of His. However, all of these surgical procedures are very invasive, regardless of whether done as a laparoscopic or an open procedure.  
         [0009]     New, less surgically invasive approaches to treating GERD involve transoral endoscopic procedures. One procedure contemplates a machine device with robotic arms that is inserted transorally into the stomach. While observing through an endoscope, an endoscopist guides the machine within the stomach to engage a portion of the fundus with a corkscrew-like device on one arm. The arm then pulls on the engaged portion to create a fold of tissue or radial plication at the gastroesophageal junction. Another arm of the machine pinches the excess tissue together and fastens the excess tissue with one pre-tied implant. This procedure does not restore normal anatomy. The fold created does not have anything in common with a valve. In fact, the direction of the radial fold prevents the fold or plication from acting as a flap of a valve.  
         [0010]     Another transoral procedure contemplates making a fold of fundus tissue near the deteriorated gastroesophageal flap to recreate the lower esophageal sphincter (LES). The procedure requires placing multiple U-shaped tissue clips around the folded fundus to hold it in shape and in place.  
         [0011]     This and the previously discussed procedure are both highly dependent on the skill, experience, aggressiveness, and courage of the endoscopist. In addition, these and other procedures may involve esophageal tissue in the repair. Esophageal tissue is fragile and weak, in part due to the fact, that the esophagus is not covered by serosa, a layer of very sturdy, yet very thin tissue, covering and stabilizing all intraabdominal organs, similar like a fascia covering and stabilizing muscle. Involvement of esophageal tissue in the repair of a gastroesophageal flap valve poses unnecessary risks to the patient, such as an increased risk of fistulas between the esophagus and the stomach.  
         [0012]     A new and improved apparatus and method for restoration of a gastroesophageal flap valve is fully disclosed in U.S. Pat. No. 6,790,214, issued Sep. 14, 2004, is assigned to the assignee of this invention, and is incorporated herein by reference. That apparatus and method provides a transoral endoscopic gastroesophageal flap valve restoration. A longitudinal member arranged for transoral placement into a stomach carries a tissue shaper that non-invasively grips and shapes stomach tissue. A tissue fixation device is then deployed to maintain the shaped stomach tissue in a shape approximating a gastroesophageal flap.  
         [0013]     Whenever tissue is to be maintained in a shape as, for example, in the improved assembly last mentioned above, it is necessary to first grip stomach tissue and then fasten at least two layers of gripped tissue together. In applications such as gastroesophageal flap valve restoration, it is desirable to grip stomach tissue displaced from the esophageal opening into the stomach so that when the stomach tissue is pulled aborally to form a flap, the flap will have sufficient length to cover the opening and function as a flap valve. With the gastroesophageal anatomy thus restored, the GERD will be effectively treated.  
         [0014]     Deploying fasteners through the flap forming stomach tissue is not a simple matter. The formed flap is generally parallel to the center axis of the longitudinal member. Hence, to deploy a fastener to maintain the flap, a fastener must be driven into the tissue layers substantially perpendicular to the tissue layers and hence perpendicular to the longitudinal member center axis. This requires a nearly ninety degree (90°) bend in the fastener driver. Such bends dramatically reduce the drive force which may be imparted to a fastener making deployment more difficult.  
         [0015]     Hence, there is a need in the art for techniques and devices which enable more ready manipulation and fastening of stomach tissue from within the stomach. The present invention addresses these and other issues.  
       SUMMARY  
       [0016]     The invention provides a transoral gastroesophageal flap valve restoration device. The device comprises a longitudinal member, a portion of which is arranged for transoral placement into a stomach, and having a longitudinal axis. The device further comprises a tissue shaper carried on the longitudinal member that shapes stomach tissue into a shape, and a fastener director that directs a fastener into the stomach. The fastener director is devoid of any deviation greater than 45 degrees.  
         [0017]     The fastener director may comprise a guide lumen that extends from the longitudinal member to the tissue shaper. The tissue shaper may comprise a pair of hingedly coupled first and second arms for receiving the stomach tissue there between, the second arm including an opening permitting the fastener to be driven through the stomach tissue while being held between the first and second arms. The second arm may have a distal end and the opening may be at the distal end of the second arm.  
         [0018]     The first arm may include a wall generally transverse to the fastener director and the fastener director may direct the fastener through the wall. The guide lumen, within the longitudinal member, communicates with the wall. The distal end of the second member is closely adjacent the wall with the opening aligned with the lumen when a fastener is directed through the stomach tissue.  
         [0019]     The device may comprise a plurality of fastener directors, each fastener director being arranged to direct a fastener into the stomach tissue along a path that is devoid of any deviation greater than 45 degrees. Each fastener director may comprise a guide lumen that extends through the longitudinal member to the tissue shaper.  
         [0020]     The invention further provides a transoral gastroesophageal flap valve restoration device comprising a longitudinal member having a longitudinal axis and a portion arranged for transoral placement into a stomach and a tissue shaper carried on the longitudinal member that shapes stomach tissue into a shape. The tissue shaper comprises a pair of hingedly coupled first and second arms for receiving the stomach tissue there between. The device further comprises a fastener director that directs a fastener into the stomach tissue along a path that is devoid of any deviation greater than 45 degrees.  
         [0021]     The invention further provides an assembly for transoral gastroesophageal flap valve restoration. The assembly comprises a longitudinal member, a portion of which is arranged for transoral placement into a stomach. The longitudinal member also has a longitudinal axis. The assembly further comprises a tissue shaper carried on the longitudinal member that shapes stomach tissue into a shape, a fastener that maintains the stomach tissue in the shape, and a fastener director that directs the fastener into the stomach tissue along a path that is devoid of any deviation greater than 45 degrees.  
         [0022]     The fastener director may comprise a guide lumen that extends from the longitudinal member to the tissue shaper. The assembly may further comprise a deployment wire arranged to slidingly receive the fastener and guide the fastener down the guide lumen and into the stomach tissue. The assembly may further comprise a pusher that pushes the fastener along the deployment wire down the guide lumen.  
         [0023]     The fastener may comprise first and second members having first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first and second members are separated by the connecting member, and one of the first and second members has a through channel for being received on the deployment wire.  
         [0024]     The tissue shaper may comprise a pair of hingedly coupled first and second arms for receiving the stomach tissue there between, the second arm including an opening permitting the fastener to be driven through the stomach tissue while being held between the first and second arms. The second arm may have a distal end and the opening may be at the distal end of the second arm.  
         [0025]     The first arm may include a wall generally transverse to the fastener director and the fastener director may direct the fastener through the wall. The guide lumen, within the longitudinal member, communicates with the wall. The distal end of the second member is closely adjacent the wall with the opening aligned with the lumen when a fastener is directed through the stomach tissue.  
         [0026]     The assembly may comprise a plurality of fastener directors, each fastener director being arranged to direct a fastener into the stomach tissue along a path that is devoid of any deviation greater than 45 degrees. Each fastener director may comprise a guide lumen that extends through the longitudinal member to the tissue shaper.  
         [0027]     According to another embodiment, a transoral gastroesophageal flap valve restoration device comprises a longitudinal member, a portion of which is arranged for transoral placement into a stomach, a tissue shaper carried on the longitudinal member that shapes stomach tissue into a shape, and a fastener director that directs a fastener along a fastener deployment wire and a path into the stomach tissue. The fastener deployment wire has a distal tip end and the tissue shaper is configured to receive and enclose the deployment wire tip end. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0028]     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 objects 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 like elements, and wherein:  
         [0029]      FIG. 1  is a front cross-sectional view of the esophageal-gastro-intestinal tract from a lower portion of the esophagus to the duodenum;  
         [0030]      FIG. 2  is a front cross-sectional view of the esophageal-gastro-intestinal tract illustrating a Grade I normal appearance movable flap of the gastroesophageal flap valve (in dashed lines) and a Grade III reflux appearance gastroesophageal flap of the gastroesophageal flap valve (in solid lines);  
         [0031]      FIG. 3  is a side view of an apparatus for restoring the flap of a GEFV according to an embodiment of the invention;  
         [0032]      FIG. 4  is a view of the apparatus of  FIG. 3  according to an embodiment of the invention being used to mold stomach tissue into a GEFV and to prepare the molded tissue for fixation;  
         [0033]      FIG. 5  is a perspective view illustrating a manner in which the device of  FIGS. 3 and 4  may deploy a fastener through molded stomach tissue layers;  
         [0034]      FIG. 6  is a perspective view showing a fastener fully deployed;  
         [0035]      FIG. 7  is a partial side view of an apparatus according to another embodiment; and  
         [0036]      FIG. 8  is a side view of another apparatus according to a further embodiment. 
     
    
     DETAILED DESCRIPTION  
       [0037]      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.  
         [0038]     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 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.  
         [0039]     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 . It is about 4 to 5 cm long ( 51 ) at it longest portion, and its length may taper at its anterior and posterior ends.  
         [0040]     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) in the neck 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  41  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]      FIG. 2  is a front cross-sectional view of an esophageal-gastro-intestinal tract illustrating a Grade I normal appearance movable flap  50  of the GEFV  49  (shown in dashed lines) and a deteriorated Grade III gastroesophageal flap  55  of the GEFV  49  (shown in solid lines). As previously mentioned, a principal reason for regurgitation associated with GERD is the mechanical failure of the deteriorated (or reflux appearance) gastroesophageal flap  55  of the GEFV  49  to close and seal against the higher pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap  50  of the GEFV  49  may deteriorate into a Grade III deteriorated gastroesophageal flap  55 . The anatomical results of the deterioration include moving a portion of the esophagus  41  that includes the gastroesophageal junction  52  and LES  48  toward the mouth, straightening of the cardiac notch  47 , and increasing the Angle of His  57 . This effectively reshapes the anatomy aboral of the gastroesophageal junction  52  and forms a flattened fundus  56 .  
         [0043]     The deteriorated gastroesophageal flap  55  shown in  FIG. 2  has a gastroesophageal flap valve  49  and cardiac notch  47  that are both significantly degraded. Dr. Hill and colleagues developed a grading system to describe the appearance of the GEFV and the likelihood that a patient will experience chronic acid reflux. L. D. Hill, et al., The gastroesophageal flap valve: in vitro and in vivo observations, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill&#39;s grading system, the normal movable flap  50  of the GEFV  49  illustrates a Grade I flap valve that is the least likely to experience reflux. The deteriorated gastroesophageal flap  55  of the GEFV  49  illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flap valve is the most likely to experience reflux. Grades II and III reflect intermediate grades of deterioration and, as in the case of III, a high likelihood of experiencing reflux. With the deteriorated GEFV represented by deteriorated gastroesophageal flap  55  and the fundus  46  moved inferior, the stomach contents are presented a funnel-like opening directing the contents into the esophagus  41  and the greatest likelihood of experiencing reflux. Disclosed subsequently is a device, assembly, and method which may be employed to advantage according to an embodiment of the invention in restoring the normal gastroesophageal flap valve anatomy.  
         [0044]     Referring now to  FIG. 3 , it shows a device  100  according to an embodiment of the present invention. The device  100  includes a longitudinal member  102  for transoral placement of the device  100  into the stomach. The longitudinal member  102  has a longitudinal axis  103 . The device further includes a first arm  104 , hereinafter referred to as the chassis, and a second arm  106 , hereinafter referred to as the bail. The chassis  104  and bail are hingedly coupled at  107 . The chassis  104  and bail  106  form a tissue shaper which, as described subsequently in accordance with this embodiment of the present invention, shapes tissue of the stomach into the flap of a restored gastroesophageal flap valve that is substantial parallel to the axis  103 . The chassis  104  and bail  106  are carried at the distal end of the longitudinal member  102  for placement in the stomach.  
         [0045]     The device  100  has a longitudinal passage (not shown) to permit an endoscope  110  to be guided through the device and into the stomach. Such a passage may be seen, for example, in copending application Ser. No. 11/172,427, filed Jun. 29, 2005, for APPARATUS AND METHOD FOR MANIPULATING STOMACH TISSUE AND TREATING GASTROESOPHAGEAL REFLUX DISEASE, and which application is incorporated herein by reference. This permits the endoscope to service as a guide for guiding the device  100  through the patient&#39;s throat, down the esophagus, and into the stomach. It also permits the gastroesophageal flap valve restoration procedure to be viewed at each stage of the procedure.  
         [0046]     As will be seen subsequently, to facilitate shaping of the stomach tissue, the stomach tissue is drawn in between the chassis  104  and the bail  106 . Further, to enable a flap of sufficient length to be formed to function as the flap of a gastroesophageal flap valve, the stomach tissue is pulled down so that the fold line is substantially juxtaposed to the opening of the esophagus into the stomach. Hence, the stomach is preferably first gripped at a point out and away from the esophagus and the grip point is pulled to almost the hinged connection  107  of the chassis  104  and bail  106 . As described in copending application Ser. No. 11/001,666, filed Nov. 30, 2004, entitled FLEXIBLE TRANSORAL ENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE AND METHOD, which application is incorporated herein by reference, the device  100  is fed down the esophagus with the bail  106  substantially in line with the chassis  104 . To negotiate the bend of the throat, and as described in the aforementioned referenced application, the chassis  104  and bail  106  are rendered flexible. The chassis  104  is rendered flexible by the slots  108  and the bail  106  is rendered flexible by the hingedly coupled links  112  including a distal link  109 . Further details concerning the flexibility of the chassis  104  and the bail  106  may be found in the aforementioned referenced application.  
         [0047]     The device further includes a tissue gripper (not shown). The gripper, as shown and described in the aforementioned copending application Ser. No. 11/172,427, comprises a helical coil. The coil is carried at the end of a cable (not shown) and may be attached to the end of the cable or be formed from the cable.  
         [0048]     With continued reference to  FIG. 3 , the device  100  further comprises a fastener director  140 . The fastener director includes a plurality of fastener deployment guides  142 . Each fastener deployment guide  142  takes the form of a guide lumen. The guide lumens extend through the longitudinal member  102  to the first member  104  and terminate at delivery points  144  where a fastener is driven into the molded stomach tissue. The delivery ports  144  are within a wall  143  of the first member that is transverse to the longitudinal axis  103  of the longitudinal member  102  and the fastener director lumens  142 .  
         [0049]     The device  100  further includes a window  130  within the chassis  104 . The window is formed of a transparent or semi-transparent material. This permits gastroesophageal anatomy, and more importantly the gastroesophageal junction (Z-line) to be viewed with the endoscope. The window includes a location marker  132  which has a know position relative to the fastener delivery points  144 . Hence, by aligning the marker with a known anatomical structure, the fastener will be delivered a known distance from or at a location having a predetermined relation to the marker. For example, by aligning the marker with the Z-line, it will be know that the fastener will be placed aboral of the Z-line and that serosa tissue will be fastened to serosa tissue. As previously mentioned, this has many attendant benefits.  
         [0050]     It may also be mentioned at this point that the device  100  further includes an invaginator  145  including a plurality of orifices  146 . These orifices  146 , which alternatively may be employed on the longitudinal member  102 , are used to pull a vacuum to cause the device  100  to grip the inner surface of the esophagus. This serves to stabilize the esophagus and maintains device positioning during the procedure. This vacuum gripping of the esophagus may also be used to particular advantage if the patient suffers from a hiatal hernia. Upon being thus gripped, the esophagus may be moved downwardly with the device toward the stomach to eliminate the hiatal hernia.  
         [0051]     Referring now to  FIG. 4 , it shows the device  100  forming a flap to restore a GEFV from stomach tissue layers  180  and  182 . The tissue layers have been pulled in between the bail  106  and chassis  104  by the gripper and cable (not shown) and the bail has been rotated about pivot  107  to close on the tissue to form a flap portion from tissue layers  180  and  182 .  
         [0052]     It may be noted in  FIG. 4  that the bail  106  has a distal end  145  that includes an opening  147 . The opening permits a deployment stylet  264 , fed down the guide lumen  142  and through the delivery port  144  to pierce through both tissue layer  180  and  182  during the deployment of a fastener through tissue layers  180  and  182 .  
         [0053]     More specifically, when the bail  106  is closed on the chassis as shown in  FIG. 4 , the wall  143  and bail distal end  145  are closely adjacent. The delivery port  144  is aligned with the opening  145  and the tissue layers are bent so that the tissue layers are disposed substantially transverse to the longitudinal axis  103  and presented to the stylet path for fastener deployment. This permits the fastener director guide lumen  142  to direct a fastener along the stylet  264  in a path that is continuously substantially parallel to the longitudinal axis  103 . This is in direct contrast to prior arrangements where the guide lumen paths were bent to present a fastener substantially transverse to tissue layers which were not bent. As a result, unlike prior arrangements, the force with which a fastener may be deployed is not diminished. Also, since the fastener is translated over a substantially straighter path, the fastener travel through the guide lumen is rendered much smoother.  
         [0054]     Hence, with the bail  106  closed on the chassis  104  with the tissue layers  180  and  182  there between and the delivery port  144  aligned with the opening  147 , the stylet may be advanced down the guide lumen  142 , through the port  144 , through the tissue layers  180  and  182  and through the opening  147  into the distal link  109  of the ball  106 . A fastener may now be deployed to fasten the tissue layers  180  and  182  together to maintain the formed flap.  
         [0055]     As mentioned above, the end of the stylet  264  is directed into the distal link  109  of the bail  106 . The distal link  109  includes a hollow portion which may be referred to as a stylet house that captures and encloses the end of the stylet  264 . The stylet distal tip  270  is thus rendered unexposed to surrounding tissue. This safety feature of this embodiment precludes the possibility of the stylet  264  causing injury to surrounding tissue.  
         [0056]     It may also be observed that the distal link  109  further includes a side port  149 . This side port  149  permits the stylet  264  to be visualized with an endoscope to assist in the proper axial positioning of the stylet  264 . It may further serve to permit visualization of the fastener being deployed to both assist in deployment and to confirm fastener deployment.  
         [0057]      FIGS. 5 and 6  illustrate a manner in which the device  100  of  FIGS. 3 and 4  may deploy a fastener  200  through the layers  180  and  182  of stomach tissue. The fastener  200  generally includes a first member  202 , a second member  204 , and a connecting member  206 . As may be noted in  FIG. 6 , the first member  202  and second member  204  are substantially parallel to each other and substantially perpendicular to the connecting member  206  which connects the first member  202  to the second member  204 .  
         [0058]     The first member  202  is generally cylindrical or can be any shape. It has a channel  212  that extends therethrough. The through channel  212  is dimensioned to be slidingly received on the tissue piercing deployment wire  264 .  
         [0059]     The first member  202  includes a pointed tip  224 . The tip  224  may be conical and more particularly takes the shape of a truncated cone. The tip can also be shaped to have a cutting edge in order to reduce tissue resistance.  
         [0060]     The first member  202  also has a continuous lengthwise slit  225 . The slit  225  includes an optional slot  226  that communicates with the through channel  212 . The slot  226  has a transverse dimension for more readily enabling receipt of the tissue piercing deployment wire  264  during deployment of the fastener  200 .  
         [0061]     The fastener member  202  is preferably formed of flexible material. The slit  225  may thus be made larger through separation to allow the deployment wire to be snapped into and released from the through channel  212 .  
         [0062]     In addition to the fastener  200  and the deployment wire  264 , the assembly shown in  FIGS. 5 and 6  further includes a pusher  266  and a guide tube  268 . The subassembly of the tissue piercing wire  264 , fastener  200 , and pusher  266  may be guided to its intended location relative to the tissue layers  180  and  182  by the guide tube  268 . The tissue piercing wire  264 , fastener  200 , and the pusher  266  are all initially within the guide tube  268 . The guide tube  268  is representative of the fastener deployment guide and to that end, includes the fastener deployment guide lumen  142 . The subassembly of the tissue piercing wire  264 , fastener  200 , and pusher  266  may be guided to its intended location relative to the tissue layers  180  and  182  by the guide lumen  142 .  
         [0063]     As shown in  FIGS. 5 and 6 , the tissue piercing wire  264  has a tip  270  helping it pierce the tissue layers  180  and  182  that will form the restored gastroesophageal flap valve. The pusher  266  has pushed the first member  202  of the fastener  200  through the tissue layers  180  and  182  on the tissue piercing wire  264 . This may be accomplished by moving the wire  264  and the pusher  266  together.  
         [0064]     As may be further noted in  FIG. 5 , the first member  202  is clearing the wire  264  and tissue layer  182 . The tissue piercing wire  264  may now be retracted into the pusher  266  and the tissue piercing wire  264  and pusher  266  may be withdrawn.  
         [0065]      FIG. 6  illustrates the fastener  200  in its fully deployed position. It will be noted that the fastener has returned to its original shape. The tissue layers  180  and  182  are fastened together between the first member  202  of the fastener  200  and the second member  204  of the fastener  200 . The connecting member  206  extends through the tissue layers  180  and  182 . If the additional fastener deployment guides are provided, the foregoing steps for deploying further fasteners may be repeated.  
         [0066]     To render the flap uniform about the opening of the orifice into the stomach, it may be necessary to rotate the device  100  and repeat the previously described procedure for forming a further flap portion. When the appearance of the valve flap is satisfactory as viewed through an endoscope, for example, the bail  106  may be moved to a fully opened position as seen, for example, in  FIG. 3  and the device  100  may be removed from the stomach and esophagus. This would then complete the procedure of restoring to GEFV.  
         [0067]     Referring now to  FIG. 7 , it shows the chassis  304  of another apparatus  300  embodying the present invention. The apparatus  300 , as in the previous embodiment, includes the fastener director  140  in the form of fastener directing guide lumens  142 . The main difference between the apparatus  300  and the apparatus previously described is that the window for observing tissue is within the wall  143  that is substantially transverse to the fastener director lumens  142 . Through this window, the color of the tissue may be readily observed so that it may be known where the Z line is and to make sure that the fasteners are driven into the stomach tissue aboral of the Z line.  
         [0068]      FIG. 8  shows yet another embodiment. Here, the apparatus  400  includes a non-linked bail  406  hingedly coupled to its associated chassis  404  at the pivot point  407 . The apparatus also includes a fastener director  440  which, as in the previous embodiments, may be one or more fastener guide lumens  442 . Here however, it will be noted that the fastener director  440  deviates from a line  446  substantially parallel to the longitudinal axis at point  448  by an angle theta (θ). The lumen  442  then terminates at the wall  443  which is still substantially transverse to the lumen  442 .  
         [0069]     As may be appreciated by those skilled in the art, the drive force applied to a fastener beyond point  448  will be split into two components, a longitudinal component, and a lateral component. More specifically, the lateral component will vary with the sine of theta and be equal to the total drive force (F) times the sine of theta (F×sine θ). Similarly, the longitudinal component will vary with the cosine of theta and be equal to the total drive force times the cosine of theta (F×cosine θ). When the lateral force becomes greater than the longitudinal force, the fastener will be pushed sideways and the longitudinal force component will become relatively ineffective at driving a fastener through the tissue as required. To make sure that the longitudinal force component is always greater than the lateral force component, F×cosine θ must always be greater than F×sin θ and theta must be no greater than 45 degrees. Hence, at the delivery end of lumen  442 , the deviation θ is no greater than 45 degrees. Further, it is preferable the fastener director be devoid of any deviation greater than 45 degrees.  
         [0070]     While particular embodiments of the present invention have been shown and described, modifications may be made, and it is thereto intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention.