US 20070005082 A1
Stomach tissue is manipulated to form, for example, a restored flap of a gastroesophageal flap valve. The manipulation includes gripping stomach tissue from within the stomach while the stomach is inflated to promote visualization and stabilization of the gripped stomach tissue. Once the stomach tissue is gripped, the stomach is deflated and pulled into a mold. The molded tissue is then fastened with at least one fastener. The stomach is inflated to a first pressure during visualization and then to a second higher pressure during the stomach tissue gripping.
1. A method of restoring a flap of a gastroesophageal flap valve associated with a stomach, comprising:
inflating the stomach;
gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach;
deflating the stomach;
pulling the gripped stomach tissue into a mold to form molded tissue; and
deploying at least one fastener through the molded tissue.
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10. A method of restoring a flap of a gastroesophageal flap valve associated with a stomach, comprising:
gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach;
collapsing the stomach;
pulling the gripped stomach tissue into a mold to form folded flap of tissue; and
deploying at least one fastener through the folded flap of tissue.
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28. A method of gripping stomach tissue from within a stomach, comprising:
visualizing the stomach from within the stomach to determine a gripping location;
inflating the stomach; and
gripping the stomach at the gripping location while the stomach is inflated.
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31. An assembly for restoring a gastroesophageal flap valve associated with a stomach, comprising:
an elongated member having a distal end for placement in the stomach; and
a gastroesophageal flap valve restoration device including a chassis and a bail carried at the elongated member distal end, the chassis having a proximal end connected to the elongated member distal end and a distal end hingedly coupled to the bail, the chassis and bail arranged to mold stomach tissue there between, the chassis further including a window that permits gastroesophageal anatomy visualization.
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40. A method of deploying a fastener through stomach tissue a predetermined distance from a gastroesophageal junction, comprising:
providing a fastener deployment apparatus, the apparatus including a window permitting visualization of gastroesophageal anatomy when placed in an esophagus, a location marker viewable in the window, and a fastener deployer that ejects a fastener for deployment at a predetermined location relative to the location marker;
feeding the apparatus down the esophagus;
aligning the location marker with respect to the gastroesophageal junction to cause the fastener deployer to be aboral of the gastroesophageal junction; and
ejecting a fastener from the fastener deployer with the location marker aligned with respect to the gastroesophageal junction.
41. A fastener deployment apparatus that deploys a fastener in body tissue, comprising:
a window permitting visualization of internal body anatomy when placed in a body;
a location marker viewable in the window; and
a fastener deployer having a predetermined orientation relative to the location marker that ejects a fastener for deployment at a predetermined location relative to the location marker.
42. A device for folding tissue, comprising a chassis and a bail, the chassis having a distal end hingedly coupled to the bail, the chassis and bail arranged to fold tissue there between, the chassis further including a window that permits anatomy visualization.
The present invention generally relates to manipulation of stomach tissue as by folding, molding, and/or fastening and to treating gastroesophageal reflux disease using such techniques. The present invention more particularly relates to locating tissue fixation devices for fixing stomach tissue to stomach tissue in surgical environments to promote reliable fixating of stomach tissue.
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.
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.
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's Esophagus) in which a cancerous esophageal adenocarcinoma can develop.
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.
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'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.
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.
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.
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.
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.
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.
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.
Locating the proper gripping point in the stomach is not a simple matter. When the stomach is empty, it is normally in a collapsed state. Visualization within the stomach is extremely difficult. Once a desired gripping point is found, it is then necessary to form the GEFV flap and maintain its shape without involving the esophageal tissue. Still further, these manipulations of the stomach tissue must be repeated many times about the esophageal/stomach opening. Such further manipulation must repeat the dimensions of the manipulated stomach tissue to result in a valve structure of uniform geometry. This is, of course, extremely difficult under the circumstances provided by the anatomy of the stomach.
In maintaining the shape of the manipulated stomach tissue, fasteners may be employed. However, care must be taken against inadvertently fixing esophageal tissue to stomach tissue. As previously mentioned, this is fraught with potential complications.
Still further, the mere act of gripping stomach tissue may be problematic. For example, one way stomach tissue may be gripped is snare it with a helical coil. In doing so, the helical coil is screwed into the tissue. Unfortunately, the mere act of turning the coil can cause the stomach tissue to also rotate and “ball-up” about the helix. Such an event greatly complicates the therapeutic procedure.
Hence, there is a need in the art for techniques and devices which enable more ready manipulation of stomach tissue from within the stomach. The present invention addresses these and other issues.
The invention provides a method of restoring a flap of a gastroesophageal flap valve associated with a stomach. The method comprises inflating the stomach, gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach, and deflating the stomach. The method further comprises pulling the gripped stomach tissue into a mold to form molded tissue, and deploying at least one fastener through the molded tissue.
The method may further comprise gripping a wall of the esophagus prior to gripping the stomach. The step of gripping a wall of the esophagus may include gripping the wall of the esophagus with a vacuum.
The method may further comprise reinflating the stomach before deploying the at least one fastener. The inflating step may include inflating the stomach to a first pressure. The method may further comprise visualizing the stomach from within the stomach after inflating the stomach to the first pressure, and increasing inflation pressure within the stomach to a second pressure after visualizing the stomach before gripping stomach tissue.
The invention further provides a method of restoring a flap of a gastroesophageal flap valve associated with a stomach, comprising gripping stomach tissue from within the stomach at a point displaced from the esophageal opening of the stomach and collapsing the stomach. The method further comprises pulling the gripped stomach tissue into a mold to form folded flap of tissue and deploying at least one fastener through the folded flap of tissue.
The gripping, collapsing, pulling, and deploying steps may be repeated for forming another folded flap of tissue. Another fastener displaced from the at least one fastener may be deployed. The method may further comprise inflating the stomach before deploying the at least one fastener.
The method may further comprise inflating the stomach before gripping the stomach tissue. The method may then comprise the further step of re-inflating the stomach prior to deploying the at least one fastener.
Before the gripping step, the stomach may be inflated to a first pressure. This may be followed by visualizing the stomach from within the stomach, and inflating the stomach to a second pressure. The second pressure may be greater than the first pressure. The method may further comprise repeating the inflating, gripping, collapsing, pulling, and deploying steps for forming another folded flap of tissue and deploying at least one other fastener displaced from the at least one fastener. The method may further comprise measuring from the folded flap of tissue prior to repeating the gripping step.
The invention still further provides a method of gripping stomach tissue from within a stomach. The method comprises visualizing the stomach from within the stomach to determine a gripping location, inflating the stomach, and gripping the stomach at the gripping location while the stomach is inflated.
The invention still further provides an assembly for restoring a gastroesophageal flap valve associated with a stomach. The assembly comprises an elongated member having a distal end for placement in the stomach, and a gastroesophageal flap valve restoration device. The device includes a chassis and a bail carried at the elongated member distal end. The chassis has a proximal end connected to the elongated member distal end and a distal end hingedly coupled to the bail. The chassis and bail are arranged to mold stomach tissue there between. The chassis further includes a window that permits gastroesophageal anatomy visualization.
The window is at the proximal end of the chassis. The device may further comprise a passage that slidingly receives an endoscope adjacent the window.
The device may further include a fastener deployment guide having a predetermined orientation relative to the window. The fastener deployment guide may comprise at least one guide lumen.
The window may include a location marker. The device may further include a fastener deployment guide that guides a fastener into molded tissue. The deployment guide may have a predetermined orientation relative to the location marker. A fastener deployer may then deploy a fastener in molded tissue at a predetermined location relative to the location marker.
The invention still further provides a method of deploying a fastener through stomach tissue a predetermined distance from a gastroesophageal junction. The method comprises providing a fastener deployment apparatus including a window permitting visualization of gastroesophageal anatomy when placed in an esophagus, a location marker viewable in the window, and a fastener deployer that ejects a fastener for deployment at a predetermined location relative to the location marker. The method further comprises feeding the apparatus down the esophagus, aligning the location marker with respect to the gastroesophageal junction to cause the fastener deployer to be aboral of the gastroesophageal junction, and ejecting a fastener from the fastener deployer with the location marker aligned with respect to the gastroesophageal junction.
The invention further provides a fastener deployment apparatus that deploys a fastener in body tissue. The apparatus comprises a window permitting visualization of internal body anatomy when placed in a body, a location marker viewable in the window, and a fastener deployer having a predetermined orientation relative to the location marker that ejects a fastener for deployment at a predetermined location relative to the location marker.
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:
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.
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.
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.
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.
The deteriorated gastroesophageal flap 55 shown in
Referring now to
The device 100 has a longitudinal passage 101 to permit an endoscope 110 to be guided through the device and into the stomach. This permits the endoscope to service as a guide for guiding the device 100 through the patient'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.
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, as will be seen, the stomach is 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. Further details concerning the flexibility of the chassis 104 and the bail 106 may be found in the aforementioned referenced application.
As further shown in
The helical coil 115 is shown in an approximate position to engage the stomach tissue out and away from the opening of the esophagus to the stomach. The helical coil 115 is guided into position by a guide structure 120 carried on the bail 106. The guide structure 120 comprises a guide tube 122. When the device 100 is first introduced down the esophagus into the stomach, the helical coil 115 is caused to reside well within the guide tube 122 to preclude the helical coil from accidentally or inadvertently snagging esophageal or stomach tissue.
The guide tube includes a longitudinal slit 126 having a circuitous configuration. The slit 126 permits the end of the cable to release or disassociate from the bail after the stomach tissue is gripped. The circuitous configuration of the slit 126 assures confinement of the cable 116 within the guide tube 122 until release of the cable is desired. The proximal end of the slit 126 has an enlarged portion or opening (not shown). This opening permits the cable and helical coil to reenter the lumen when the device 100 is readied for a repeated stomach tissue shaping procedure. To that end, the guide 118 has a conical surface that serves to guide the cable end back into the opening of the slit 126.
With continued reference to
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 110. The window includes a location marker 132 which has a know position relative to the fastener delivery point 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.
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 will serve to stabilize the esophagus and maintain 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.
Now that a device 100 according to the present invention and which may be used in a method of restoring the flap of a gastroesophageal flap valve according to this embodiment of the present invention has been described, reference may now be made to
Next, the bail 106 is moved to be substantially in line with the chassis 104. Next, the endoscope 110 is inserted into the device with an appropriate lubricant on the endoscope. Next, a bite block, of the type well known in the art, is inserted into the patient's mouth. A lubricant may be applied to the device and the device may now be inserted through the bite block in the subject's mouth. With the endoscope leading the device as illustrated in
As previously mentioned, the device 100 is able to clear the bend in the patient's throat by virtue of being flexible as previously described. With the endoscope serving as a guide tube, very little force should be needed to get the device around the neck into the pharynx and down into the esophagus.
Once the device is positioned in the stomach as shown in
Referring now to
Referring now to
Next, the device positioning relative to the Z-line 52 is checked to make sure that the marker 132 is in its desired position relative to the Z-line 52. In accordance with this embodiment, the marker 132 is placed adjacent or is aligned with the Z-line 52.
With the device in the correct starting position as shown in
Referring now to
With the helical coil 115 firmly seated in the tissue, the wind-up in the cable 116 is released. Referring now to
With the bail 106 slightly opened and the helix 115 engaged with the tissue 43, the interior of the stomach is now deflated through the endoscope 110. The stomach should be deflated such that the tissue appears loose and collapsed with the Mucosa folds being prominent. However, enough room should be left to view the device.
Referring now to
With the tissue layers 180 and 182 now disposed within the mold of the chassis 104 and bail 106, the bail 106 may now be locked with respect to the chassis 104. It is now time to fasten the tissue layers 180 and 182 together by ejecting a fastener from the fastener deployer lumen 142 at the fastener delivery point 144.
Before a fastener is ejected from the fastener deployer lumen 142, the stomach is once again inflated through the endoscope 110. The stomach is inflated to a point where one has a good view of the tissue fold and bail 106.
The first member 202 is generally cylindrical or can any shape. It has a channel 212 that extends therethrough. The though channel 112 is dimensioned to be slidingly received on a tissue piercing deployment wire 264.
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.
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. Also, because the fastener member 202 is formed of flexible material, the slit 225 may be made larger through separation to allow the deployment wire to be snapped into and released from the through channel 212.
In addition to the fastener 200 and the deployment wire 264, the assembly shown in
As shown in
As may be further noted in
In accordance with a further method of utilizing the fastener deployment assembly of
With the fasteners successfully deployed, the vacuum pull through orifices 146 may now be turned off to release the device from the esophagus wall as illustrated in
To render the flap uniform about the opening of the orifice into the stomach, it is necessary at this time to rotate the device 102 and repeat the previously described procedure for forming a further flap portion. Before this is done, however, it is desirable to position the bail 106 to an almost closed position. Then, the device 100 is moved aborally further into the stomach until the tip end 107 of the bail 106 comes to rest on the tip 151 of the newly formed flap portion. This is the location where the helical coil 115 will next engage the stomach tissue for molding and fixating as previously described.
The foregoing is repeated until a complete valve flap is formed. When the appearance of the valve flap is satisfactory as viewed through the endoscope for visual confirmation, the helical coil 115 is reloaded back into its original position with the device 100. The vacuum suction through orifices 146 is turned off to release the wall of the esophagus from the device. The bail 106 is then moved to a fully opened position as seen, for example, in
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.