US20060241662A1 - Method for performing endoluminal fundoplication and apparatus for use in the method - Google Patents

Abstract

A method and device for performing endoluminal fundoplication are described. A device is inserted in the patient's stomach through the esophagus, including an unit adapted to grasp and pull a portion of the gastroesophageal junction into the stomach, and an unit adapted to move a portion of the fundus towards the esophagus. The device also can place fasteners to hold the gastric wall and the esophageal wall secured together, thus forming a valve between esophagus and stomach. An adhesive compound can be used to stabilize the juncture of the two walls.

Description

• This application is a continuation of application Ser. No. 10/773,308, filed Feb. 9, 2004, which is a division of application Ser. No. 09/675,601, filed Sep. 29, 2000, now U.S. Pat. No. 6,736,828, all of which are incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention relates generally to the art of fundoplicating the stomach to the esophagus. More specifically, the present invention relates to a method for performing such a fundoplication endoluminally, and to an apparatus for securing the fundus to the esophagus.
BACKGROUND OF THE INVENTION
• Fundoplication is a surgical procedure which is typically used to treat Gastroesophageal Reflux (GER) condition, a malady often resulting from a deformity of the gastroesophageal junction (GEJ), and/or a dysfunctional lower esophageal sphincter (LES). One symptom commonly associated with GER is regurgitation or reflux of stomach contents into the esophagus. Fundoplication procedures are directed towards manipulating esophageal and gastric tissue so as to form a valve at the GEJ which limits reflux into the esophagus. The valve is formed by manipulation of the esophagus so as to invaginate the stomach, then wrapping the fundus of the stomach around the distal end of the esophagus and securing the stomach in that wrapped position.
• The most commonly used fundoplication procedures require abdominal or thoracic incisions through which the abdominal wrapping and securing can be performed. Due to the highly invasive nature of such surgery,2 complications and morbidity occur in a significant percentage of cases. In addition, these procedures are lengthy, often taking a number of hours to perform, and may leave disfiguring scars where the incisions were made.
• Other recently developed fundoplication procedures somewhat limit the necessity of making large surgical incisions by utilizing laparoscopic ports or percutaneous endoscopic gastrostomy. (See, e.g. U.S. Pat. Nos. 5,403,326, and 5,088,979, the contents of which are hereby incorporated by reference). Although these procedures are less invasive than those involving large abdominal and thoracic incisions, they are invasive nonetheless, and have costs and risks associated with such invasive surgery. For example, general anaesthesia is typically used during these procedures which adds to the expense of these procedures and entails well known risks.
• In addition to the complications, risks, and costs associated with the invasive nature of current fundoplication methods, these methods have other problems as well. One such problem is unwrapping of the fundus, also referred to as slippage of the fundal wrap. Slippage frequently occurs with current methods, as they fail to adequately secure the plicated fundus.
SUMMARY OF THE INVENTION
• The present invention is directed to a method for endoluminal fundoplication in which a flexible endoscope is first used to locate an attachment site at the gastroesophageal junction. A tissue grasping device is then positioned at the distal end of the endoscope, and attached to the body tissue at the located attachment site. Next, a tissue displacement device is positioned at the distal end of the endoscope and used to displace the fundus of the stomach, so as to create an intussusception of the esophagus into the gastric lumen. A fastener delivery device is then positioned adjacent to a first desired fastener delivery location and used to place a first fastener through the tissue which forms the intussusception at the desired fastener delivery location. The first fastener secures a first portion of the gastric fundus to the esophagus. The fastener delivery device is then used to place additional fasteners at a plurality of additional desired fastener locations, thus securing the gastric fundus around the esophagus. In one exemplary embodiment, the fastener delivery device, the tissue grasping device, and the tissue displacement device can be incorporated into a single unit.
• Finally, an injection device is positioned at the distal end of the endoscope and used to inject a bonding agent into the tissue which forms the intussusception. For example, the bonding agent can be an agent for fibrotic fixation or adhesion.
• In one embodiment, the invention is a method for performing endoluminal fundoplication of a patient's esophagus and stomach, having the steps of forming an intussusception of the esophagus into the stomach by pulling a selected portion of the esophagus into the stomach, and by displacing a fundus portion of the stomach towards the esophagus, placing a fastener across the intussusception, said fastener maintaining an esophageal wall and a gastric wall forming the intussusception adjacent to one another, and injecting a bonding agent between the esophageal wall and a gastric wall to bond the intussusception.
• In another embodiment, the invention is a device for performing endoluminal fundoplication of a patient's esophagus and stomach, comprising a flexible tube having a distal end adapted for insertion in the stomach through the esophagus, a tissue grasping device disposed at the distal end of the flexible tube, adapted to grasp a selected portion of the esophagus, a tissue displacement device disposed adjacent the tissue grasping device, adapted to move a fundus portion of the stomach towards the esophagus and an anvil portion, pivotable relative the tissue displacement portion, wherein the tissue displacement device and the anvil portion releasably carry complementary portions of a fastener, such that said complementary portions are joined when the fundus portion is moved towards the esophagus.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will be more readily understood through the following detailed description, with reference to the accompanying drawings, in which:
• FIGS. 1 through 4 illustrate the method of endoluminal fundoplication according to one embodiment of the present invention;
• FIG. 1 shows a cross-sectional view of the distal end of an esophagus and the upper gastric wall, with an endoscope inserted through the esophagus and into the gastric lumen, and a tissue grasping device attached to a site on the gastroesophageal junction;
• FIG. 2 shows the cross-sectional view as inFIG. 1 and, in addition, shows a tissue displacement device and the gastric fundus displaced so as to form an intussusception of the esophagus into the gastric lumen;
• FIG. 3 shows the cross-sectional view as inFIG. 2 and, in addition, shows a tissue fastener device and a fastener placed through the intussusception;
• FIG. 4 shows a cross-sectional view of the distal end of an esophagus and the upper gastric wall, with an endoscope inserted through the esophagus and into the gastric lumen, two fasteners placed within the intussusception, and an injection device inserted into the intussusception;
• FIG. 5 shows a cross-sectional view of an intussusception of the esophagus into the gastric lumen with a hypotube inserted through both the esophageal and gastric walls;
• FIG. 6 shows the cross-sectional view as inFIG. 5, with the distal end of a T-fastener deployed;
• FIG. 7 shows the cross-sectional view as inFIG. 5, with the hypotube retracted from within the body tissue, and with both the proximal and distal ends of the T-fastener deployed;
• FIG. 8 shows an elevation view of a T-fastener with a T-bar bolster at each end;
• FIG. 9 shows an elevation view of a fastener with a four-pronged bolster at each end;
• FIG. 10 shows an elevation view of a fastener with a three-pronged bolster at each end;
• FIG. 11 shows an elevation view of a fastener with a six-pronged bolster at each end, in which the prongs are curved;
• FIG. 12 shows an elevation view of a fastener with inflatable bolsters on each end;
• FIG. 13ais a longitudinal view of a fastener with deformable portions near each end, with the fastener in the undeformed position;
• FIG. 13bis a longitudinal view of the fastener shown inFIG. 13a,with the deformable portions near each end in the deformed position;
• FIG. 14 is an isometric drawing showing another embodiment of a fastener according to the invention, having a portion with a barbed tack, and another portion with a mating washer;
• FIGS. 15aand15bare cross sectional views showing two embodiments of an endoscope, with one and two overtubes;
• FIGS. 16a,16b,16cand16dare side views showing the deployment device for a fastener according to another embodiment of the present invention; and
• FIGS. 17ato17eare diagrams showing the steps of operation of a different embodiment of a system according to the present invention, which includes a fundoplication device.
DETAILED DESCRIPTION OF THE INVENTION
• The method of the present invention can be performed, for example, using aflexible endoscope16, which is preferably equipped with a tissue grasping device18 (shown inFIG. 1), a tissue displacement device22 (shown inFIG. 2), a fastener delivery device24 (shown inFIG. 3), and an injection device28 (shown inFIG. 4). The endoscope preferably has one or more oversheath channels through which various devices may pass. For example, the endoscope may be equipped with a tissue displacement device which passes through the lumen of an oversheath channel, and can be controllably extended past the distal end of the endoscope by the endoscopist. In addition, the endoscope preferably has a second oversheath channel through which a fastener delivery device passes and an injection device operable at its distal end. The endoscopist can operate the endoscope, including the tissue grasping device, tissue displacement device, fastener delivery device, and injection device from the proximal end of the endoscope.
• Different types of endoscopes can be used for this procedure. If necessary, an overtube with one or more passages can be slipped over the endoscope to the location of the fundoplication, to facilitate insertion of additional tools. For example,FIG. 15ashows anendoscope16 havingseveral channels15 that provide irrigation, suction, illumination and video feedback. Thisexemplary endoscope16 includes one working channel A. To facilitate insertion of additional tools, anovertube20 can be used, forming a sheath that defines additional working channels E and F that reach the distal end ofendoscope16. Similarly,FIG. 15bshows anendoscope16′ having two working channels A and B. In this case, anovertube20′ only has to provide a passage for one additional working channel F. In this discussion, an “endoscopic device” is used to generally indicate and endoscope and, when required, an overtube defining additional working channels.
• In one embodiment, the patient's stomach is insufflated to facilitate the operation. The patient can also be sedated with an intravenous anesthesia injection during the procedure.
• Using the present method, theflexible endoscope16 is first inserted into the patient's mouth, passed through theesophagus10 and into the stomach, as shown inFIG. 1. The insertedendoscope16 is then used to locate anattachment site14 at the gastroesophageal junction. The endoscopist, or other practitioner performing the procedure, can locate the site by viewing the GEJ through the endoscope. These methods for endoscopically locating target sites are well known and widely used in the art.
• Thetissue grasping device18 can be positioned at the locatedattachment site14, and engaged so as to grasp and hold that tissue, as shown inFIG. 1. Thetissue grasping device18 passes through a lumen of theendoscope16 and is operable from the proximal end of theendoscope16 by the practitioner. Preferably, the practitioner can control the engaging/disengaging of thedevice18, as well as the tension which thedevice18 applies to the engaged tissue. This tension can be controlled by extending thedevice18 past or retracting thedevice18 towards the distal end of theendoscope16. The means with which thetissue grasping device18 engages, or grasps, and holds the tissue can consist of a hook, clamp, grasper, a combination thereof, or the like, as is known in the art.
• After tissue at the GEJ has been grasped, thetissue displacement device22 is used to displace thegastric fundus12 so as to effectively create anintussusception30 of theesophagus10 into thestomach32, as shown inFIG. 2. Thetissue displacement device22 passes through a lumen of anovertube20 which surrounds theendoscope16, and can be pushed or rotated to a position distal to the distal tip of theendoscope16. Thedevice22 preferably comprises aspherical tip23 located at the distal end of a stiff cable or Nitinol band. The practitioner can operate thetissue displacement device22, for example, by pushing and rotating it into position against the gastric fundus.
• Once in position against thegastric fundus12, thetissue displacement device22 is further pushed and rotated so as to press against and reposition thegastric fundus12. Simultaneously, thetissue grasping device18 holds the tissue at theattachment site14, applying a force which opposes force supplied by thetissue displacement device22. The net effect of these counteracting forces is that thegastric fundus12 is brought in closer proximity to the esophagus, which makes the angle of His, identified at reference numeral34, more acute. The displacement of thegastric fundus12 creates atissue flap30, which is effectively an intussusception of theesophagus10 into thestomach32. In one preferred embodiment, the flaps of tissue can have an approximate length between 1 and 3 cm.
• In a preferred embodiment, the steps of pulling the tissue with thetissue grasping device18 and displacing the fundus with thetissue displacement device22 are repeated at several positions around the circumference of the intussusception. For example, the procedure can be performed at four to twelve equidistant locations around the circumference of the esophagus.
• The reduction in the angle of His34 and formation of anintussusception30 reduces the degree to which stomach contents can reflux into theesophagus10. A valve is essentially built between the stomach and the esophagus. As gases build up in thegastric lumen32 and, more specifically, in thegastric fundus12, pressure is brought to bear on the wrapped portion of theesophagus10, closing it off from the stomach. In addition, stomach contents move around within thegastric lumen32 due to contraction of the stomach muscles, and body movement in general. Theintussusception30 alleviates GER by creating a valve like barrier which stomach contents must pass through in order to reach theesophagus10.
• Theintussuscepted esophagus30 is then fastened to the wall of thegastric fundus12 to fix the arrangement. Thefastener delivery device24 is used to insertfasteners26 within theintussusception30 to hold the gastric and esophageal tissue in place. Since a number of nerves and blood vessels typically run through the tissue being manipulated, the practitioner should, before inserting thefasteners26, locate the nerves and blood vessels, so as not to damage or sever them. In particular, the practitioner should locate the Vagus nerve bundle which runs alongside the esophagus, the aorta, and the various gastric blood vessels. Numerous methods for locating such anatomical features are well known in the art, including use of ultrasound, fluoroscopy and x-ray.
• Once the aforementioned features are located, the practitioner loads afastener26 into thefastener delivery device24 and inserts thedevice24 through asecond sheath channel25 until the operating end of thedelivery device24 is positioned at a desired fastener insertion site. Thedevice24 is then used to place a fastener at a desired site, as shown inFIG. 3.Fasteners26 are preferably inserted through the intussusception at 1 cm and 2.5 cm above thetip14 of the newly-formedtissue flap30, which extends into thegastric lumen32. Thefasteners26 can be inserted also at other locations along the length of the tissue flap, which in the preferred case has a length of between about 1 and 3 cm.
• Thefastener delivery device24 can be rotated within the esophagus and gastric lumen so as to insert fasteners around the entire circumference of the esophagus. Preferably, fasteners are inserted at locations approximately 30° apart. For example, from an initial insertion site, thedevice24 may be rotated in one direction, inserting fasteners at 30°, 60°, 120°, and 180° from the initial site. Thedevice24 is then returned to the initial insertion site and rotated in the opposite direction, again inserting fasteners at, for example, 30° intervals, until the entire circumference of the intussusception has been fastened.
• Preferably, the intussusception should extend a full 360 degrees, i.e., the entire circumference of the esophagus. The valve formed by the intussusception is similar to the “gerd standard” open or laparosopic procedure, a Nissen Fundoplication. However, a full 360 degrees may not be achievable with an endoluminal approach. In that case, a Toupet fundoplication, spanning approximately 270 degrees of the circumference around the esophagus can be performed. The endoluminal procedure thus cannot generally be performed on an arc of approximately 60 degrees, on the backside of the esophagus. In the remaining portion of the esophagus circumference, fasteners can be attached, for example, at 30 degrees intervals.
• FIG. 5 shows ahypotube40 with a beveled edge which has been inserted through thefastener delivery device24 and further advanced so as to penetrate tissue of both the esophageal and gastric walls,44 and46 respectively.Hypotube40 can be, for example, an hypodermic needle cannula, or another type of thin tubing, preferably of stainless steel.
• A T-fastener42 of the type known in the art can be inserted through thehypotube40 until the distal end of thefastener42 is deployed on the stomach side of the intussusception. Thehypotube40 is then retracted towards thesheath24 so that the deployed distal end of the T-fastener engages thegastric wall46 as thehypotube40 is retracted, as shown inFIG. 6. As shown inFIG. 7, thehypotube40 is further retracted into thesheath24 until the proximal end of the T-fastener is pulled out of thehypotube40 by the tension exerted from the distal end of the T-fastener42. The proximal end of the T-fastener42 then seats against the inner wall of the esophagus, thereby holding the gastric wall and the esophagus together. The length of the longitudinal center portion of the T-fastener determines the maximum distance between the inner wall of the esophagus and the inner wall of the fundus.
• FIGS. 9-11 illustrate various configurations of T-fasteners which may be used to secure the esophageal and gastric walls. The traditional T-fastener48 has a simple T-bar at each end. With this fastener, the forces of securing the gastric and esophageal tissue in the post-deformation position are borne by the T-bars at each end of the fastener, which have a small area over which to distribute the forces. This type of T-bar may pull through either the gastric or esophageal wall. Thus, it may be desirable to utilize T-fasteners in conjunction with the present invention which have T-bar configurations with increased area over which the forces of securing the tissue will be distributed.
• FIG. 9 shows a T-fastener with two T-bar bolster at each end. In addition, the area over which the forces of securing tissue are distributed can be increased by, for example, utilizing a T-fastener with three prongs, four prongs, or six prongs. (Shown inFIGS. 10, 9, and11 respectively.)
• FIG. 12 shows analternative fastener56 which can be used to secure gastric and esophageal tissue according to the present invention. Thefastener56 has a longitudinal center portion withinflatable balloons58 at each end. Thisfastener56 may be inserted through the gastric and esophageal tissue in the same manner as that described above with respect to T-fastener insertion. Once thefastener56 is in place, air, water or other material may be introduced into the inflatable ends58, thereby inflating theends58 and securing the gastric and esophageal tissue. The inflatable ends may be spherical or disk-shaped.
• In one exemplary embodiment, the balloon can be formed on the distal end offastener42, as shown inFIG. 12, and can be stored inhypotube40 during insertion throughwalls44,46. Ashypotube40 is retracted, the balloon can be inflated with a fluid passing through an inflation tube formed withinhypotube40. A similar process can take place to inflate a balloon at the proximal end offastener42, before separation fromhypotube40. Seals of known design can be used to maintain both balloons inflated.
• FIGS. 13-14 show yet anotheralternative fastener60 which may be used to secure gastric and esophageal tissue according to the present invention. Thefastener60 is a longitudinal member withdeformable portions62,64 near the proximal and distal ends, and may preferably be made of polypropylene or other biocompatible durable material.
• Thedeformable portions62,64 preferably have a mesh-like structure which may be expanded radially by, for example, buckling when the ends of thefastener60 are compressed toward on another. Thefastener60 is inserted into the gastric and esophageal tissue in the same manner as described above with respect to T-fastener insertion, as shown inFIGS. 5-7. When the proximal and distal ends are in desired positions within the esophagus and the stomach respectively, the ends are expanded.
• In one exemplary embodiment, thefastener60 may be formed such that it is normally biased toward the deformed position, as shown inFIG. 13b.Afastener60 of this type can be maintained in the reduced diameter configuration while contained within in thehypotube40, and would expand due to its natural bias upon release therefrom. Thedeformable portions62 and64 are compressed so as to allow insertion of the fastener through thedelivery device24 and through both gastric and esophageal tissue. Thefastener60 can then be advanced through thehypotube40 until the distaldeformable portion64 exits the distal end of thehypotube40, and regains its normally radially expanded position. Thehypotube40 can then be retracted, allowing the proximaldeformable portion62 to expand to its normally radially expanded position. Thedeformed portions62 and64 then act as bolsters which secure the gastric and esophageal tissue in place.
• Alternatively, afastener60 withdeformable portions60 may be formed such that it is normally in the un-deformed position, as shown inFIG. 13a.The normally un-deformed fastener would be inserted through the gastric and esophageal tissue in the same manner as described above with respect to the normally deformed embodiment. The normally un-deformed fastener must then be manipulated into the deformed position shown inFIG. 13bafter being placed in the desired position spanning the esophageal and stomach tissue. A crimping device, inserted through the lumen of the endoscope, can be used to perform such manipulation. This device may resemble a known mechanism used for inserting rivets. As would be understood by those skilled in the art, any device which may be inserted through the lumen of an endoscope and which can compress the ends of thefastener60 so as to buckle the deformable portions may be used as the crimping device.
• Thefastener60 may also be formed with a needle-like point at its distal end to aid insertion. Such a distal end would enable insertion of thefastener60 directly through the gastric and esophageal tissue, eliminating the need for thehypotube40.
• As shown inFIG. 16, thehypotube40 previously described with reference toFIGS. 5-7 can be replaced with aninsertion device100 that deploys afastener102. Wheninsertion device100 is in position across the esophageal andgastric walls44,46, as shown inFIG. 16a,anactuating wire104 that extends the length ofendoscope16 is pulled, so that adistal stent106 is deployed, as seen inFIG. 16b.As theinsertion device100 is withdrawn,actuating wire104 is pulled again as shown inFIG. 16c,so thatproximal stent108 is deployed, and thewalls44,46 are sandwiched betweenstents106,108, as shown inFIG. 16d.
• In a different embodiment according to the invention, a two-piece fastener comprising abarbed tack70 and amating washer74, as shown inFIG. 14, may be employed. Thebarbed tack70 consists of adisk portion71 with abarbed connector72. Thebarbed connector72 can be inserted through themating washer74 such that theconnector72 is engaged by thewasher74. Bothcomponents70 and74 can preferentially be made of a resilient polymeric material.
• In one alternative exemplary embodiment of a device according to the invention, thebarbed tack70 andmating washer74 may be inserted using afundoplication device120, that is described inFIGS. 17ato17e.FIG. 17ashows adevice120 at the end of aflexible tube121, that is inserted throughesophagus10 into the patient'sstomach32. Anendoscope16 can also be introduced, to visually monitor the procedure. Once in position,device120 deploys a pivotabletissue displacing portion124, shown inFIG. 17b,that is moved in position towards thegastric fundus12.
• A grippingportion128 ofdevice120 is used to grasp anattachment site14 at the gastroesophageal junction, as shown inFIG. 17c,so that downward movement ofdevice120 pulls that region of theesophagus10 intostomach32. Aspike130 can also be used to facilitate this procedure. Once the esophagus opening is in the proper position,tissue displacement portion124 is pivoted towards ananvil portion126 of thedevice120, so thatfundus12 is pushed towards the esophagus, forming an intussusception.
• Whentissue displacement portion124 reachesanvil portion126, as shown inFIG. 17d,thebarbed portion70 of the fastener, mounted ontissue displacement portion124, pierces thegastric wall46 andesophageal wall44, and is secured tomating washer74, mounted onanvil portion126. This procedure results in formation of a flap oftissue132. As previously discussed for other embodiments according to the invention, this procedure can be repeated at different circumferential locations around the esophagus, to form a valve of desiredshape separating stomach32 fromesophagus10, as shown inFIG. 17e.
• Finally, a bonding agent can be injected into the tissue of the intussusception, as shown inFIG. 4, causing a fibrotic reaction which secures the gastric and esophageal tissue of the fundoplication. Sodium morrhuate, for example, is a known agent that may be injected into the tissue fold formed between the gastric and esophageal tissue, so as to create a fibrotic reaction that adheres the gastric fundus to the esophagus permanently.
• Several compounds can be used as bonding agents. For example, among the adhesive compounds, cyanoacrylate can be used, as well as fibrin sealant, muscle adhesive protein, Transforming Growth Factor Beta, Prolamine gel, Gelatin-Resorcinol-Formol glue and Hystoacryl. Among the sclerosant compounds, Morrhuate Sodium, Sodium Tetradecyl Sulfate, Ethanolamine Oleate, aerosol-tale and sterile Bleomycin Sulfate can be used.
• When such a bonding agent is used, the fastener need only secure the tissue until the reaction caused by the agent has sufficiently secured the tissue in place. The fastener used may then be made of a biodegradable or bioabsorbable material, or can be removed.

Claims (3)

1-17. (canceled)

18. A device for performing endoluminal fundoplication of a patient's esophagus and stomach, comprising:

a flexible tube having a distal end adapted for insertion in the stomach through the esophagus;

a tissue grasping device disposed at the distal end of the flexible tube, adapted to grasp a selected portion of the esophagus;

a tissue displacement device disposed adjacent the tissue grasping device, adapted to move a fundus portion of the stomach towards the esophagus; and

an anvil portion, pivotable relative the tissue displacement portion, wherein the tissue displacement device and the anvil portion releasably carry complementary portions of a fastener, such that said complementary portions are joined when the fundus portion is moved towards the esophagus.

19-22. (canceled)

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