Abstract:
A medical staple formed from a nitinol wire, the staple having two elongated arms which extend upwardly and outwardly from a central loop in two opposing generally semicircular courses forming an arc extending upwardly and outwardly and an end second comprising a sharpened endpoint, the endpoint being the arms bendable under resistance, is disclosed. In some embodiments the arms extend upwardly on a parallel course and then outwardly. The material is preferably an alloy with hyperelastic characteristics. The staples are placed in a flexible endoscope and a lumen catheter within the endoscope, using a hook or forceps in the lumen catheter having a distal end in the lumen of the catheter and the staple distal to the forceps in folded configuration with the arms folded inward in the lumen catheter, positioning the distal end of the lumen catheter at a location in the patient&#39;s gastrointestinal tract where stapling is desired, moving the forceps distally so as to force the staple forward out of the lumen catheter and cause the end points to pierce the patient&#39;s inner wall of the gastrointestinal tract.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims benefit of provisional applications Ser. No. 60/747,712 filed May 19, 2006 and 60/884,770 filed Jan. 12, 2007. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to the field of medicine, particularly to securing medical devices to tissue or organs, and to reversing the procedure and removing the devices. 
     The most common way to secure medical tissues to tissues or organs is by stapling with conventional surgical staples formed from a single length of wire in an approximate U-shape. For example, McGarry, et al., in U.S. Pat. No. 5,366,479, disclose endoscopic application of staples for attaching surgical mesh to body tissue in laparoscopic hernia surgery. In this patent, the stapler is a rigid instrument and cannot be used through the mouth into the esophagus where a flexible instrument is needed. Furthermore, the stapling system of this patent is not reversible. 
     For certain types of devices placed through the mouth, conventional stapling with a rigid stapler is not possible and so various alternatives using flexible instruments have been devised. For example, to treat a condition known as Gastro-Esophageal Reflux Disease (GERD), a tubular valve has been designed for letting free passage of food from the esophagus into the stomach but stopping food and gastric content such as hydrochloric acid and bile from refluxing from the stomach into the esophagus. Godin, U.S. Pat. No. 5,861,036, described a Gastro-esophageal Anti-Reflux Device (GARD) and Godin, U.S. Pat. No. 6,764,518 described a system for securing the GARD comprising a ring which could be collapsed into a smaller diameter for placement through the mouth and placed in a hiatus hernia after calibration of the diameter of the hernia with a catheter. Such ring was designed to place the GARD tubular valve in the lower esophagus or in a hiatus hernia associated with severe GERD and keep it in place for a significant amount of time, such as months and years, as severe GERD is a chronic condition. 
     While the aforementioned method of placing a GARD worked for some patients, it was insufficient in certain cases. 
     In a different approach to addressing GERD, endoluminal fundoplication surgery, a flexible endoscope was disclosed by Adams, et al., in U.S. Pat. No. 6,736,828, as being useful in endoluminal fundoplication surgery where a bonding agent is injected into tissue which forms an intussusception formed by pulling a selected portion of the esophagus into the stomach and displacing a fundus portion of the stomach towards the esophagus, placing a fastener across the intussusception for maintaining an esophageal wall and a gastric wall forming the intussusception adjacent to one another and then injecting the bonding agent to bond the intussusception. The disclosed fasteners are all symmetrical at both ends. Adams, et al., did not describe a flexible echo endoscopic procedure. The intussusception site is located by Adams, et al., by viewing the gastroesophogeal junction (GEJ) through the endoscope. The fastener is preferably made of polypropylene but can alternatively be made of a biocompatible material and can be a T-fastener. The fastener is inserted through a hypotube which first penetrates tissue of both the esophageal and gastric walls; then the T-fastener is inserted so the distal end of the T-fastener engages the gastric wall as the hypotube is retracted; and then the hypotube is further retracted into the sheath of a fastener delivery device. The proximal end of the T-fastener is pulled out of the hypotube by the tension exerted from the distal end of the T-fastener and then the proximal end seats against the inner wall of the esophagus, thereby holding the gastric wall and the esophagus together. One of the T-fasteners has a simple T-bar at each end, referred to herein as a fastener since the T-bars are normally biased in a T-configuration with respect to the longer joining portion but can be maintained in a reduced diameter configuration, with the T-bars “tilted” or compressed toward the longer joining portion, while inserted and maintained in a hypotube such as a hypodermic needle delivery device. Such fasteners are advanced through the hypotube until the distal portion exits the distal end of the hypotube delivery device and then regains its normally radially expanded position. In Adams, the T-bars when placed on both sides of the intussusception are visible on both sides with conventional endoscopes as one T-bar is on the esophageal side and the other one on the gastric fundal side. No echoendoscope is necessary and none is described. The Adams T-bars are not used to hold a device attached to the mucosa. 
     A system for suturing, tissue fixation, and transgastric penetration to facilitate surgery on the wall of the GI tract and adjacent hollow organs under Endoscopic Ultrasound (EUS) control was described by Fritscher-Ravens, et al., in Gastrointestinal Endoscopy, vol. 56, No. 5, 2002, pgs. 737 to 742. In this paper, one single tag is placed under EUS control through the mucosa. A free piece of thread as described in Figs. A-E on page 738 comes out of the tag and from the tip of the needle that is modified in order to let the thread come out of the needle. The free thread has then to be attached using either suturing systems or pledgets or tying knots that are not easily done or used through a flexible endoscope. Furthermore, the Fritscher-Ravens, et al., system was not described for use for securing medical devices, for example a GARD, to the gastrointestinal tract or any other organ. 
     A rigid rather than flexible laparoscopic surgery appliance for installing temporary plastic resorbable fasteners, for example for fixing parietal and visceral reinforcements, is described by Bailly, et al., in U.S. Pat. No. 6,779,701. Bailly, et al., teach binding nets for treatment of inguinal hernias. A plunger for forcing the catching bars to pivot is disclosed. 
     A self-securing suture wire with a T-shaped toggle designed for insertion into a bodily structure, tissue, or organ, delivered by a slotted needle, is disclosed by Levinson, et al., in U.S. Pat. No. 6,596,014. The toggle end portion can be made of nitinol, stainless steel, or biocompatible material. The suture is designed to be placed in a blood vessel from the outside of the vessel. 
     A T-bar fastener with a sharp end or point on the bar-like head portion, or T, so that the sharp end or point embeds itself in body tissue to securely anchor the T-bar head is disclosed by Richards, et al., in U.S. Pat. No. 4,669,473. A tool receives a fastener with the bar-like head positioned inside a bore of a sheath and the filament portion of the fastener extending out through a slot in the tool bore, the head making a sliding fit in the sheath. 
     Staples of various configurations have been suggested for unrelated surgical procedures and applications, for example for repair of arteries, Phillips, et al., US Patent Pub. 2003/0033006, disclose a device with a central section for abutment contact with the inner wall of a graft and two elongate members with distal ends for contacting the outer wall of the artery when the device is pierced through the graft and the artery. In FIGS. 7 and 8 of Phillips, et al., a device with a central loop is shown in unstressed configuration and in stressed configuration in a delivery tube. 
     A suture anchor was described by Gatturna, et al., U.S. Pat. No. 5,192,303 wherein a coupling member at one end and a barb on the other end are used to anchor a suture to bone. 
     Irnich, et al., U.S. Pat. No. 3,814,104, disclose a pacemaker electrode with an electrode tip having two crossing arms and a central loop. 
     It is an object of the present invention to provide a method and apparatus for esophageal and gastrointestinal stapling. 
     It is another object to provide an improved device for effectively securing medical devices to a patient&#39;s inner mucosa and reversibly remove the staple. 
     It is a further object to provide an improved apparatus for securing a GARD valve to a hiatus hernia or wall of a gastro-intestinal tract of a patient suffering from severe GERD associated with a hiatus hernia. 
     A still further object is to provide an improved staple for stomach stapling surgery to treat obesity and a method of reversing such stapling surgery for obesity. 
     It is also an object to place a manometric probe or several manometric probes in the colon to treat Irritable Bowel Syndrome (IBS). 
     A still further object is to use the clips to staples with a joining ring and make stomach folds in the cardia, i.e., the upper part of the stomach, to make pleats to treat mild to moderate GERD. 
     A still further object is to use the staples to create a small reservoir in the upper part of the stomach to create a restrictive pouch in the stomach to treat moderate obesity, creating a reversible endoscopic vertical banding gastroplasty. 
     It is a further object to use pairs of staples to create a horizontal line of stapling creating a small gastric cavity at the top of the stomach, at the cardia, mimicking endoscopically the gastric pouch obtained by the laparoscopic banding (LAP-BAND) operations for obesity. 
     It is a further object to provide an improved device for effectively securing restrictive and bypass tubes to treat obesity, called OB tubes as described in PCT/US06/35568. 
     SUMMARY OF THE INVENTION 
     These objects, and others which will become apparent from the following disclosure, are achieved by the present invention which in one aspect comprises a gull shaped staple having two wings and a central loop, the staple formed from a single length of flexible, resilient metal alloy wire. The wings may be folded inward for insertion in a catheter of the type used for flexible endoscopy. The staple may be placed by a surgeon, gastroenterologist, or other medical professional, using a flexible catheter with a grasping forceps in the catheter, placed through the working channel of a gastroscope or endoscope. For loading the staple, the grasping forceps grasps the central loop of the staple and pulls the staple in the catheter. The catheter is placed through the working channel of the endoscope. When in position the tip of the catheter is firmly applied against a device being implanted or against tissue for stapling, the grasping forceps is pushed out of the catheter, which expels the staple. The staple immediately resumes its original wing shape so that the wings open and the staple is placed in position. 
     In order to remove the staple, under endoscopic control, the tooth of the grasping forceps seizes the loop in the middle of the staple and the staple is pulled back into the catheter. Then the catheter with grasping forceps and staple can be removed out of the body of the patient. 
     Another aspect of the invention is a surgical method comprising attaching a medical device to the inner mucosa of a gastro-intestinal tract of a patient with a the gull shaped staple using a conventional straight viewing video or fiberoptic endoscope or a lateral viewing endoscope for positioning of the staples. In order to assure stability and avoid a back-jump of the flexible endoscope while firing, an inflatable balloon can be attached at the tip of the endoscope and inflated before firing the staple. The balloon is deflated after firing so that the forceps can move and release or ungrasp the staple. Alternatively, an overtube with an internal part sold by US Endoscopy under the name the Guardus overtube can also be used with or without the internal introducer part to give stiffness to the endoscope when firing the staple. 
     Another aspect of the invention is a surgical method comprising attaching medical devices to the inner mucosa of a gastro-intestinal tract of a patient with a the gull shaped staple using ultrasound real time visualization and a flexible endoscope in order to determine exact penetration of the wall of the GI tract. 
     An additional aspect of the invention is an article useful for implanting a medical device comprising an electrical lead, a flexible joining member, and a gull shaped staple at a terminal end used for attaching an electronic pace setter. 
     Another aspect is a method of implanting a medical device having an electrical lead comprising providing a terminal staple of the aforementioned gull shaped configuration on an electrical lead or a flexible joining member attached to an electrical lead, placing the staple in a first lumen of the lumen catheter, injecting saline solution through the second lumen, and using ultrasound to implant the staple, thereby fixing the electrical lead of the medical device in a predetermined layer of the GI tract. 
     Another aspect of the invention, a device as described in my U.S. Pat. No. 6,764,518, referred to as the GARD device, can be inserted through the mouth and the esophagus and, when located at the intersection of the esophagus and stomach mucosa, a ring portion of the GARD device is stapled to a hiatus hernia with the gull shaped staples using a flexible endoscope with forward view or lateral view as in a standard gastroscope or a lateral view duodenoscope, which facilitates precise placement and stapling. In some embodiments the ring described in my aforementioned U.S. Pat. No. 6,764,518, FIG. 1, is modified. Oval holes are punched through the ring at regular intervals around the circumference. In certain embodiments, the spring in the ring has 10 loops and, under every second loop, an oval hole is punched through the ring. The oval hole has to be wide enough to fit the tip of the flexible catheter holding the staple. Around the ring, a narrow 0.2 mm to 0.3 mm net or mesh of polypropylene or a net made of another biocompatible material dipped in silicone is glued around the ring to close the holes. This configuration allows the tip of the catheter with the staple to fit into the niche created by the holes to avoid slippage of the catheter before shooting the staple. Also, the thinner wall created by the net will allow the staple to hold the ring and attach the ring and the device to the wall of the esophagus/hernia. In order to make the oval holes more visible endosopically, a colored marking such as a black ring of biocompatible silicone around the hole can be added to make the niche more visible for the endoscopist and help him/her see the holes for stapling. 
     In certain embodiments, a balloon is attached outside of the endoscope. Before shooting the staple with the catheter, the balloon is inflated. The inflated balloon blocks the tip of the endoscope in the ring of the GARD device or the ring of the OB tubes and prevents the endoscope from jumping back or backfiring when the staple is fired. The inflation of the balloon allows better penetration of the staples through the ring and into the tissues without risking a back movement of the flexible endoscope and incomplete penetration of the staple, which can happen when no balloon is used. After the staple is fired, the balloon is deflated. The selection of the diameter of the inflated balloon depends on the diameter of the endoscope and the inner size of the ring. The diameter of the inflated balloon in some embodiments is between 5 mm and 25 mm, preferably between 10 mm and 20 mm. The purpose of the balloon is to make the tip of the flexible endoscope more rigid. Alternatively the inner tube of a Guardus overtube can be used. The inner tube acts like a rigidifying sheath for the flexible endoscope and allows better penetration of the staples through the silicone ring, closing the holes and the tissues to which the device has to be attached. 
     In the case of surgical treatment of obesity, the invention comprises a device as described in my PCT/US06/35568 filed Sep. 11, 2006, which is hereby incorporated by reference, describing a GARD and an alternative procedure to staple the stomach endoscopically and reversibly vertically or horizontally in order to do a gastric restrictive operation for moderate obesity or yet to staple a by-pass tube from the esophagus to the small bowel and pace the gastro-intestinal tract to allow progression of the alimentary bolus for morbid obesity. 
     In my PCT/US06/35568 in which tubes with an upper ring to treat obesity are described, said upper ring may also be modified with oval holes and netting wrapped around the ring to allow implantation of the reversible staples. The holes can be underlined in some embodiments with a different color biomaterial such as black silicone. 
     In some embodiments, the staple of the invention is constructed of a single length of nitinol wire formed into a central loop, two parallel-like arms with each of the arms extending from the parallel direction in two opposing courses formed of an arc extending upwardly and outwardly and two ends comprising sharpened endpoints, the endpoint being more than about 0.5 mm above the top part of the central loop, depending on the size of the staple, the arms bendable under resistance; the article adapted to fold so as to fit within a flexible tube having an internal diameter of about 2 mm to 4 mm and to unfold elastically when pushed out of the tube at a location through the medical device. 
     The staple is preferably constructed of nickel-titanium alloy, and staples of such material are novel and advantageous for several reasons. In most embodiments the staple will use the hyperelastic characteristic of nickel-titanium alloy, allowing folding under stress in a narrow tube for placement in a catheter and resuming the original position when unstressed without permanent deformation of the staple. 
     For applications where temporary staples are needed, the staples can be constructed of biodegradable material, as long as the material is elastic enough to return to normal position after bending the tags to a substantially parallel position during the insertion steps. Such temporary applications include stapling to the esophagus or gastro-intestinal tract of captors monitoring pressure, pH and/or temperature or any other physical parameter. The biodegradable staple can be made of absorbable materials such as lactide, glycolide, or e-caprolactone for such temporary placement. 
     For permanent applications such as with a GARD device, the flexible joining material can be made in implant grade steel, nitinol, surgical thread, or implant grade polymer such as nylon, for example. However, nitinol (nickel-titanium alloy) is the preferred material because of its hyperelastic characteristics. The wing at each end of the joining member can also be made of steel, nitinol, implant-grade polymers such as nylon or any other biocompatible implantable material. In a preferred embodiment, the wing and flexible joining segment are each made of a non-absorbable material, preferably the aforementioned nitinol alloy which exhibits the flexibility needed when released from the catherer. In most cases the staples are constructed in an hyperelastic nickel-titanium alloy that does not use the configuration changes from martensite to austenite. The hyperelastic characteristics of the nickel-titanium alloy allows the staples to be pulled (loaded) in a relatively narrow catheter of 2 mm to 3.0 mm in diameter and when released to conserve the hyperelastic characteristics and almost instantly resume the original wing shaped configuration to function as a staple. To remove the staple, in one embodiment a toothed forceps grasps the loop of the staple and the staple is pulled back into the catheter for removal through the endoscope. An important advantage of certain embodiment of the invention is the reversibility of the stapling operation and the simplicity of the removal of the staples. 
     For treatment of IBS, one or more manometric probes are placed in the colon using the stapling system of this invention. The manometric probes are described in PCT/US03/13773, which is hereby incorporated by reference. The staple can attach a device to the alimentary tract but can also be used directly on the mucosa, often in pairs linked by a central ring, either to create a pleat or to staple two opposite walls of the alimentary tract together as in stapling the posterior wall to the anterior wall to create a gastroplasty. Also, part of each staple is flat, not curved, so as to stay in the muscularis layer of the gastro-intestinal tract. The staple ends are sharpened but at introduction the hyperelastic nitinol staple can be introduced in a smaller needle and, when released in the tissues, adopts the original configuration. Also, when using an endoscope, the catheter can be placed in a niche of a ring to avoid slippage, then the staple can be expelled through the catheter with a hook or a small forceps. 
     Several shapes of symmetrical staple wings can be used in order to allow suitable stapling force, yet allow the staple to be removable. 
     The staples can be kept at room temperature as their hyperelastic characteristic is used in stapling reversibly at flexible endoscopy. 
     In order to attach two opposite staples together to create as gastric reservoir to treat obesity in a vertical or horizontal line of staples, two staples are first placed opposite to each other on the posterior and anterior walls of the stomach. Then a thread is passed with a forceps and the flexible endoscope through the mouth and through the central ring of the staple and pulled out again. A standard gastroscope or, preferably, a double channel endoscope, can be used to facilitate the passage of the thread through the central loop and pulling it through the loop and out again. The same procedure is repeated with the other staple. Two double threads are then at the mouth of the patient and a small thin-walled titanium tube is then slid over the four pieces of thread through the mouth and esophagus into the stomach, allowing approximation of the anterior and posterior walls. Once the small titanium tube is in placed near the two central rings of the two staples, the tube is crimped with a forceps passed in the second working channel of the endoscope. The four threads are cut and the same procedure is repeated to create a small reservoir. A horizontally placed line of staples can be placed with a small opening for food. This operation mimics the laparoscopic banding operation, with the advantage of being done non-invasively through the mouth with staples that are reversible. Alternatively, a small circular joining element can attach both central loops of the two staples to gether. 
     In some embodiments a tilt-tag is attached to the central loop with a non-resorbable surgical thread to prevent the staple from being placed too deeply and to help in retrieving the staple. 
     When a tilt-tag is used, a catheter having an outer sheath and a forceps with a tooth can be used to grab the central loop and pull the staple into the catheter to load the catheter and place the tilt-tag in the outer sheath. In some embodiments the catheter can have a long flexible part and a short metal tube, for example about 3 to 4 cm, which will lodge the staple. The end of the catheter can be cut in order to end as a short 3 mm needle with a thin slit in the upper part of the tube to let the surgical thread linking the staple in the flexible catheter and the tilt-tag placed in the outer tube. The staple with tilt-tag is loaded by pulling the central loop of the staple into the catheter with the toothed forceps, for example. The surgical joining thread passes through the narrow slit of the needle and the tilt-tag is placed in the outer sheath. In these embodiments, a larger diameter catheter may be needed in order to accommodate the tilt-tag in the outer sheath. In some embodiments an endoscope or gastroscope with a 3.7 mm or larger channel such as the Olympus GIF 1T 30, a GIF XT30, a FIG. 2T 20, or video endoscope XTQ 160 can be used. Certain endoscopes have multiple channels, which are suitable for use with staples having tilt-tags. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1   a  illustrates a top view of an embodiment of a staple according to the invention. 
         FIG. 1   b  illustrates a side elevational view of the staple of  FIG. 1   a.    
         FIG. 1   c  illustrates a side elevational view of a second embodiment of a staple of the invention. 
         FIGS. 2 ,  3 ,  4 , and  5  illustrate several additional embodiments of the staple according to the invention. 
         FIG. 6   a  illustrates an embodiment of a rounded tip grasping forceps holding a staple. 
         FIG. 6   b  illustrates an embodiment of a rounded tip grasping forceps holding a staple folded in a flexible tube 
         FIG. 7   a  illustrates an embodiment of a needle tipped flexible catheter with a stopper and a hook. 
         FIG. 7   b  illustrates an embodiment of a staple being grasped by a flexible catheter. 
         FIG. 7   c  illustrates an embodiment of a staple pulled into a catheter. 
         FIG. 8   a  to  8   c  illustrate the different stages of one of the embodiments of the staple when it is loaded then fired. 
         FIG. 9   a  illustrates a perspective view of a needle with a hook in a catheter grasping one staple according to the invention. 
         FIG. 9   b  illustrates a perspective view of a needle with a two-pronged rounded tweezer in a catheter loaded with one staple according to the invention. 
         FIG. 10  illustrates a partial cutaway view of an esophagus with a straight viewing endoscope and a rounded end catheter inserting one staple of the invention through both a gastrointestinal anti-reflux device (GARD) and the inner mucosa. 
         FIG. 11  illustrates a partial cutaway view of the esophagus with a lateral viewing endoscope, a needle catheter, and a balloon inserting one staple of the invention through both a GARD and the inner mucosa. 
         FIGS. 12   a  and  12   b  illustrate a side elevational cutaway view and a top cross-sectional view of a GARD stapled to the inner mucosa in the muscularis layer of the mucosa, with the staple being pulled out toward the inside in an uninstalling operation. 
         FIG. 13  illustrates the positioning of staples in pairs through a straight viewing gastroscope in order to create pleats to treat mild to moderate gastrointestinal reflux disease (GERD). A larger balloon (not shown) can be used to apply the end of the endoscope to the mucosa. 
         FIG. 14  illustrates the OB device stapled to the lower part of the esophagus or in a hiatus hernia. 
         FIG. 15  illustrates a vertical series of pairs of staples stapling the anterior wall of the stomach to the posterior wall and creating a vertical banding gastroplasty for obesity, endoscopically and with reversible staples. 
         FIG. 16  is a cross-sectional view of posterior and anterior walls of a stomach stapled with two staples and joined with a ring. 
         FIG. 17  is a top view of two staples joined by a small open ring through the loops of the staples. 
         FIG. 18  is a partial cross-sectional view of a stomach which illustrates a horizontal line of staples creating a small reversible reservoir to treat obesity. 
         FIG. 19  is a view of two double threads placed through the loops of the staples and a cross-sectional view of a thin-walled tube sliding on the threads in order to join two stomach walls and create a gastric reservoir. 
         FIG. 20  illustrates the tube of  FIG. 19  that has been crimped and blocking the threads to create the gastric reservoir. 
         FIG. 21  illustrates how two pairs of double threads passed in the central loop held together by the crimped tube separate the top part of the gastric reservoir from the main portion of the stomach in the bottom. 
         FIG. 22  is a cross-sectional view of a stomach and a perspective view of a GERD tube stapled from the lower esophagus along the lesser curvature of the stomach passing the middle of the stomach, creating a vertical reservoir similar to vertical banding gastroplasty. 
         FIGS. 23   a  thru  23   e  illustrate different lengths of OB tubes creating internal by-pass tubes stapled from the lower part of the esophagus through the stomach ( FIGS. 23   a  and  23   b ) duodenum ( FIGS. 23   c  and  23   d ) or junction of duodenum and jejunum ( FIG. 23   e ). 
         FIG. 23   f  illustrates a long OB tube reaching the jejunum and with a pace-maker and leads. 
         FIG. 24  illustrates a removable staple holding a manometric probe in the lumen for treatment of Irritable Bowel Syndrome (IBS). 
         FIG. 25  is a perspective view of an embodiment of a staple and tilt tag joined by surgical thread. 
         FIG. 26  is a perspective view of a staple joined by surgical thread to a second embodiment of a tilt tag via a knot of thread. 
         FIG. 27  is a perspective view of a staple joined to a tilt tag via a hook or ring at the distal end of the tilt tag. 
         FIG. 28  is a GARD tube with placed in an esophagus, the tube having holes for placement of staples. 
         FIG. 29  is a view of a staple with tilt tag being inserted through a hole in a GARD ring with a flexible tube having a stopper. 
         FIG. 30  is a view of a staple being inserted through a hole in a GARD ring with a flexible tube, forceps, outer sheath, tag, and thin net system. 
         FIG. 31  is a side elevational partial cross-sectional view of a flexible catheter having a needle formed from a metal tube cut at a slant with edges sharpened, a forceps with a tooth in the central lumen of the needle, a stopper to limit the depth to which the needle may be inserted, a staple with tilt tag joined by surgical thread illustrated distal to the tip of the needle prior to being grabbed by the teeth or tooth of the forceps. 
         FIG. 32  is a side elevational view of the catheter-needle-forceps system illustrated in  FIG. 31 , illustrating the staple being pulled into the needle by action of the forceps grabbing the central loop of the staple and pulling in a proximal direction, with the tilt tag located in the lumen of the outer sheath but outside of the needle. 
         FIG. 33  is a top elevational view of the catheter-needle forceps system of  FIG. 32 , illustrating a lateral slit in the sharpened needle which receives the surgical thread connecting the tilt tag and staple when the staple is pulled into the needle and the tilt tag is placed in the lumen of the catheter outside of the needle. 
         FIG. 34  is a side elevational cross-section of a staple-loop-thread-tilt tag system with the staple inserted through a hole in the GARD ring and through the net of the GARD, with the central loop of the staple within the ring and through the net of the GARD, with the central loop of the staple within the hole and the tilt tag loosely connected with thread to the central loop and disposed on the inside of an esophagus. 
         FIG. 35  is a similar view to  FIG. 34 , illustrating the thread passed in the ring or hook at the ends of the tilt tag and the tilt tag tightened against the central loop of the staple. 
         FIG. 36  illustrates a pair of staples inserted in two tissue walls of a stomach with tilt tags facing each other and thread from the first staple-tag system being used to join the second staple-tag system of the pair. 
         FIG. 37  illustrates the pair of staples of  FIG. 36  wherein the thread has cross-hooked the opposing tilt tags and has tightened the tilt tags toward each other so as to draw the two opposing tissue walls toward each to form a gastric stapling. 
     
    
    
     DETAILED DESCRIPTION 
     Referring first to  FIGS. 1   a  and  1   b , an example of a staple  10  of the invention is shown wherein a first  1  and a second  2  wing are joined perpendicularly at respective ends of joining member  3 . In the illustrated embodiment, the staple  10  is molded in one piece from Nitinol, commercially available nickel-titanium alloy. Distance A in  FIG. 1   a  varies between 4 mm and 30 mm but preferably 6 mm to 20 mm, and more preferably 10 mm to 16 mm. Preferably, the distance from the bottom of the loop to the endpoints is about 2.0 mm or more to avoid the endpoints piercing back into the lumen. Distance B can vary between 1 mm and 5 mm depending on the organ in which the staple is used (the stomach is much thicker than the esophagus or small and large bowel) but preferably is about 3 mm. Distance D in  FIG. 1   b  can vary between 2 mm and 10 mm depending on the organ in which the staple is used (the stomach is much thicker than the esophagus or small and large bowel). Distance C in  FIG. 1   b  can vary between 0.5 mm to 4 mm, more preferably about 2.0 mm. Importantly, Distance E which determines the distance between the base of the central loop  3  and the sharpened tip of wing  4  can vary between −2 mm and 10 mm (depending on Distance D), having a negative value when the tip  4  is below the base of the central loop  3  ( FIG. 1   c ). 
     Referring to  FIG. 2 , an example of a staple  10  of the invention is shown wherein a first wing  1  and a second wing  2  are parallel at a portion adjacent to central loop joining member  3 . Each of the wings  1  and  2  extend from the parallel direction in two opposing courses forming an arc  5  extending upwardly and outwardly and two ends  4  comprising sharpened endpoints, the endpoint being in this example a Distance D, of 1.0 mm above the top part of the central loop, but can be varied, depending on the size of the staple. Distance A, the width of the staple, is 15 mm in this example, and distance F, the length of the parallel segment between the bottom of the loop  3  and the beginning of the arc  5 , is 3.0 mm in this embodiment. 
     Staple  10  is preferably molded in one piece from nickel-titanium alloy such as Nitinol, a brand of commercially available nickel-titanium alloy. 
     Referring now to  FIGS. 3 ,  4  and  5 , several variations of the staples are illustrated. In  FIG. 3  both wings  1 ,  2  of the staples  10  are roughly perpendicular to the parallel elements  1   a  and  2   a . In  FIG. 4  the ends have an S shape and in  FIG. 5  the ends are facing backwards towards the central loop. 
     Referring now to  FIGS. 6   a  and  6   b , the staple  10  is pulled ( FIG. 6   a ) with a grasping forceps  6  with a little tooth  12  and inserted in a flexible catheter  7  which is slightly wider than the diameter of the joining member, allowing both wings to bend inside the flexible catheter  7  as in  FIG. 6   b . The flexible catheter  7  acts as a sheath for the forceps  6  and staple  10  assembly. The flexible catheter  7  is preferably made in a Pebax thermoplastic elastomer flexible tube. A short tube  8  can be welded, glued or otherwise attached at the end of the Pebax flexible tube to avoid excessive friction of the endpoints  4  of the staples  10  when loading into the catheter  7  and particularly when expelling of the staple  10  in tissue is desired. 
     The flexible Pebax catheter  7  with the forceps  6  and the staple  10  are passed in the working channel of a standard endoscope. In order to place the staple  10  in tissue or through a medical device such as a GARD, the rounded tip  9  of the catheter  7  is placed against the device or tissue that has to be stapled ( FIG. 10 ) and the staple  10  is pushed out with the forceps  6 . 
     Referring to  FIGS. 7   a  and  7   b , a variation of the catheter is presented where the rounded end as in  FIG. 6   a  is alternatively a sharpened needle  11 . Rather than a tooth  12 , a small hook  14  is used to grab the staple  10  by its central loop  3 . In order to control the depth of penetration and to avoid causing lesions of organs beyond the wall of the esophagus or hernia such as the aorta or vena cava, a stopper  13  can be placed at a predetermined distance from the tip of the needle  11 , for example between about 3 mm and 20 mm, and preferably about 4 mm to 6 mm. Such stopper can be used to hit the inner wall of the GARD and avoid deep penetration. Alternatively, a mark (not shown) on the needle  11  can inform the surgeon of the depth of penetration but will not control it. An echoendoscope EUS (not shown) could also be used for that purpose, however few endoscopists use EUS echoendoscope on a regular basis. A stopper or echoendoscope are not necessary when a round end catheter  9  ( FIG. 6   a ) is used and the staple  10  with sharp endpoints  4  is used to staple the device and penetrate tissue, which is an advantage of the embodiment of  FIGS. 6   a  and  6   b.    
     Referring now to  FIG. 8   a , a staple  10  is shown being grabbed by central loop  3  and being pulled in the direction of the arrow into the round ended flexible catheter  7  with the forceps  6 . In  FIG. 8   b , the catheter  7  is shown loaded with the staple  10  being held by forceps  6 . 
       FIG. 8   c  illustrates firing out the staple of the round end of catheter  7  in tissue  15 . 
     Referring now to  FIG. 9   a , a different embodiment of forceps  6  has a hook  16  that pulls the staple  10  in the flexible catheter  7 . 
       FIG. 9   b  illustrates a staple  10  having been loaded in a catheter  7  with forceps  6  having hook  16 . 
     Referring now to  FIG. 10  GARD  100  anti-GERD valve is shown in place and the flexible catheter  7  with round end  9  have been passed through the flexible endoscope  16  through an overtube  17 . The round tip  9  of the catheter  7  has been placed in a niche of the ring  80  and the staple  10  is positioned in the wall of the hernia  90 . Several staples  10  will be placed around the perimeter of the ring  80 . In this embodiment the central loop  3  acts to prevent staple  10  from going all the way through ring  80 . 
     In this way, without tying complicated knots or using any pledgets or other devices to attach the free piece of thread, a reversible staple can be placed through the inner wall of the gastrointestinal tract and hold any device in place that needs to be held either for a long period of time such as the GARD that is placed for years, or shorter periods of time such as pressure, pH monitoring devices or other pressure devices that can be placed for a few weeks. When used with absorbable staples the monitoring devices will fall in the lumen of the esophagus, stomach or bowel once he staples and joining segment dissolve and will be expelled naturally. When used with the reversible staples, each staple  10  can be recovered by flexible endoscopy by pulling on the central loop  3 . 
     Referring to  FIG. 11  a lateral viewing endoscope  160  (or a standard straight viewing endoscope) is placed through an overtube  17 , and balloon  300  is blown to offer a certain amount of counter-pressure. The staple  10  is placed in the ring  80  of the GARD  100  for reversible stapling using the balloon  300  to maintain the forceps  6  toward the ring  80 . 
     Referring to  FIG. 12   a  an enlargement shows staple  10  in the muscular layer of the gastro-intestinal wall  15 . Removal of the staple illustrated in  FIG. 12   b  which shows a direction arrow toward the inside of esophagus  15  with staple  10  being pulled by central loop  3 . 
     Referring to  FIG. 13 , staples  10  are placed in pairs at the cardia region of the stomach  60 , creating a pleat  70  to block mild reflux. The endoscope  160 , overtube  17 , and needle  7  catheter with forceps  6  are also shown. The overtube or the inner part of the Guardus overtube sold by US Endoscopy can act as a counterpressure device where the balloon cannot be used because the stomach organ is large. 
     Referring to  FIG. 14  staples  10  attach an obesity OB  200  device using the same technique as described in placement of the GARD in  FIG. 13 . OB tubes  200  are preferably those disclosed in my U.S. Pat. No. 5,861,036 which is hereby incorporated by reference and are usually longer than 10 cm for treatment of obesity, using the ring disclosed in U.S. Patent Publication 20030009239 of Jan. 9, 2003, also incorporated by reference, preferably with the ring  80  having a zig-zag shaped nitinol spring  81 . 
     Referring to  FIG. 15 , a vertical reservoir  82  is made along the lesser curvature with a series of removable staples placed in pairs  10   a  and  10   b  and linked together to staple the posterior wall of the stomach  61  to the anterior wall  62  as shown in  FIG. 16 . This operation, made endoscopically with a straight viewing endoscope, allows a reversible reservoir to be made to treat obesity. 
       FIG. 17  shows detail of the linking of the two staples  10   a  and  10   b  of a pair. The staples  10   a  and  10   b  can be linked by a ring  20  or sutured together by two threads as illustrated in  FIG. 18  which shows a horizontal endoscopic reversible stapling of the stomach for obesity. A small reservoir is made in “A”. An anterior reversible staple  10   a  is placed on the anterior wall  62  with a double thread  30  to the mouth, a second reversible staple  10   b  is placed on the posterior wall  61  of the cardia of the stomach  30  with a thread  30  and a small tube  40  is slid from the mouth on both threads and crimped in place  50  as illustrated in FIG.  19 ,  FIG. 20  and  FIG. 21 . Both threads are cut as in  FIG. 21 . This procedure is repeated along the width of the cardia leaving a small passage for food. This procedure creates a reservoir A similar to the reservoir currently created by the prior art laparoscopic band, but endoscopically and reversibly according to the invention. 
     The process of linking two staples can also be used to repair tears in a stomach or esophagus. Such tears can be accidental or can be intentional. A relatively new technique involves intentionally perforating the stomach in order to do operations endoscopically but outside of the stomach. A problem faced in the use of this new technique is how to close the perforations which were intentionally made. The use of two staples  10  and  10   a  ( FIG. 17 ) with thread connecting them, one on either side of the tear, can be used to repair such tears. 
     Referring to  FIG. 22 , an obesity tube  200  is introduced in the stomach  60 , stapled  10  to the hiatus hernia  90 . This tube  200  creates a small reservoir as in  FIG. 14  but is longer and easier to staple in place than creating a reservoir as in the operation described in  FIG. 15  with a series of pairs of staples. 
     Referring to  FIG. 23   a , an internal by-pass tube  200  is introduced in the stomach and stapled  10  to the lower esophagus or hiatus hernia  90 , allowing food to pass directly into the stomach  60 . 
       FIG. 23   b  illustrates total gastric bypasses according to the invention. 
       FIG. 23   c  illustrates total gastric bypass and partial duodenum  83  bypass with bypass tube  200  and stapled  10  to lower esophagus  84 . 
       FIG. 23   d  illustrates a total gastric  60  bypass and total duodenum  70  bypass tube  200 . The tube  200  can be semipermeable to allow fluids to pass but stops food particles to enter the stomach  60 , duodenum  83 , and proximal jejunum  75 , causing a calibrated malabsorption. The length of the tube  200  is calibrated according to the excess weight loss, creating a “pseudo” short bowel syndrome. 
       FIG. 23   e  illustrates a total gastric  60  bypass with total duodenum  83  bypass and partial intestinal (jejunal  75 ) bypass. 
       FIG. 23   f  illustrates a total gastric  60  bypass, total duodenum  83  bypass, partial intestinal (jejunal  75 ) bypass with a stimulator in the form of a gastrointestinal pacemaker  500  and the leads  600 . The tube can let gastric and duodenal water secretions penetrate in the tube  200  but not to leave it, thereby decreasing the length of small bowel used for absorption of food and causing weight loss. The tube leaves space  65  between the wall of the duodenum  83  and the external wall so that bile secretion and pancreatic secretions as well as gastric secretions can flow freely. A stimulator  500  can be used to pace the stomach  60 , duodenum  83  and small bowel to allow peristaltic contractions (not shown) transmitted to the inner tube for progression of the bolus of food in the tube. Contractions induced to the gastrointestinal tract by the pace setter stimulator  500  increase the pressure in the bypass tube  200 . 
     Referring to  FIG. 24  a staple  10  is placed in the wall of the colon  400  using the same technique as described in  FIG. 10  using a colonoscope or sigmoidoscope. The staple  10  holds a manometric probe  450  that transmits pressure readings telemetrically to a sensor  480  held outside the body to treat irritable bowel syndrome (IBS). 
     Referring to  FIG. 25 , an embodiment of staple  10  having a tilt tag  18  attached with surgical thread  30  to central ring  3  and secured at tilt tag hook  50  is illustrated. Using the tilt tag  18  helps prevent implantation of the staple  10  too deeply in either GARD ring  80  ( FIG. 30 ) or tissue  60  ( FIG. 13 ). 
       FIG. 26  illustrates an embodiment of tilt tag  18  using a knot  11  of thread  30  rather than the hook  50  of  FIG. 25 . 
       FIG. 27  illustrates thread  30  engaged to hook  50  of tilt tag  18 . 
       FIG. 28  illustrates a GARD valve  100  having thick ring  80  with holes  19  placed in esophagus  84 . The ring  80  has a thin net  85 , with silicone covering holes  19 . 
       FIG. 29  illustrates an example of a staple  10  with tilt tag  18  being inserted through a hole  19  in a GARD ring  80  with a flexible tube  7  having a stopper  13 . 
       FIG. 30  is an embodiment of a staple  10  being inserted through a hole  19  in a GARD ring  80  with a flexible tube, forceps  6 , outer sheath  17 , tag  18 , and thin net  85  system. 
       FIG. 31  shows a flexible catheter  7  having a needle  91  formed from a metal tube cut at a slant  92  with edges sharpened, a forceps  6  with a tooth  93  in the central lumen of the needle, a stopper  13  to limit the depth to which the needle  91  may be inserted, a staple  10  with tilt tag  18  joined by surgical thread  30  illustrated distal to the tip of the needle prior to being grabbed by the teeth or tooth  93  of the forceps  6 . 
       FIG. 32  is the catheter-needle-forceps system illustrated in  FIG. 31 , illustrating the staple  10  being pulled into the needle  91  by action of the forceps  6  tooth  93  grabbing the central loop  3  of the staple  10  and pulling in a proximal direction, with the tilt tag  18  located in the lumen of the outer sheath  86  but outside of the needle  91 . 
       FIG. 33  is a top view of the catheter-needle forceps system of  FIG. 32 , illustrating a lateral slit  94  in the sharpened needle  91  which receives the surgical thread  30  connecting the tilt tag  18  and staple  10  when the staple  10  is pulled into the needle  91  and the tilt tag  18  is placed in the lumen of the catheter  86  outside of the needle  91 . 
       FIG. 34  illustrates a staple-loop-thread-tilt tag system with the staple wings  1 ,  2  inserted through a hole  19  in the GARD ring  80  and through the net  85  of the GARD, with the central loop  3  of the staple within the hole  19  and through the net  85  of the GARD, and the tilt tag  18  loosely connected with thread  30  to the central loop  3  and disposed on the inside of an esophagus. The thread  30  passed in the ring or hook  50  of at the ends of the tilt-tag  18  tightens the tilt-tag  18  against the loop  3  of the staple. 
       FIG. 35  is a similar view to  FIG. 34 , illustrating the thread  30  passed in the ring or hook  50  at the ends of the tilt tag  18  and the tilt tag  18  tightened against the central loop  3  of the staple. 
       FIG. 36  illustrates a pair of staples  10 ,  10   a  inserted in two tissue walls  15 ,  15   a  of a stomach with tilt tags  18 ,  18   a  facing each other and thread  30  from the first staple-tag system being used to join the second staple-tag system of the pair. 
       FIG. 37  illustrates the pair of staples of  FIG. 36  wherein the thread  30  has cross-hooked the opposing tilt tags  18 ,  18   a  and has tightened the tilt tags  18 ,  18   a  toward each other so as to draw the two opposing tissue walls  15 ,  15   a  toward each to form a gastric stapling. 
     While the invention has been described in detail and several embodiments have been illustrated, other embodiments, alternatives, and modifications should become apparent to those skilled in the art without departing from the spirit and scope of the invention.