Abstract:
The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation or anchor is placed and secured into soft tissue. An objective of this invention is to provide a method to reduce gastroesophageal reflux by endosonography-guided intervention. Specifically, endosonography is used to insert a ligation element through the esophageal wall, through the diaphragmatic crus and into the fundus of the stomach. This ligation element placed from the esophagus and around the Angle of His to create a barrier to gastroesophageal reflux.

Description:
CLAIM OF PRIORITY 
     This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/688,837, filed Jun. 9, 2005, the entire contents of which are hereby expressly incorporated by reference. 
    
    
     BACKGROUND 
     1. Field of the Invention 
     The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation or anchor is placed and secured into soft tissue. 
     2. Background of the Invention 
     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 refluxing back into the esophagus. 
     Surgical fundoplication is the gold standard for anatomic correction of the cardia in patients with GERD. However this procedure can have a high incidence of postoperative complications and extended recovery times. Therefore endoscopic methods for enhancing the lower esophageal sphincter have been developed as an alternative to surgery. Endoscopic treatments of GERD target the esophageal and gastric wall in the region of the lower esophageal sphincter. Methods including suture plication, radiofrequency energy ablation, and implant insertion are employed to prevent reflux by mechanisms that include the creation of a mechanical barrier by narrowing the lumen, altering the esophago-gastric angle (angle of His or “flap valve”), and altering the lower esophageal sphincter to enhance its function or decrease transient lower esophageal sphincter relaxations. The endoscopic methods can be performed entirely through the endoscope placed transorally, avoiding any abdominal incisions. 
     Endoscopic treatment is often limited because the operator can only visualize the mucosal lining of the gastrointestinal wall that is located directly in front of the endoscope. Structures deep within the wall, and outside the wall, cannot be seen. The ability to visualize these structures may influence the proper placement of a treatment apparatus and may expand the therapeutic strategies. For example placement of a suture or ligating element through the esophageal and fundal walls that also includes placement through the diaphragmatic crura may be useful. The use of endoscopic ultrasonography may address this limitation. In this procedure a combination endoscope and ultrasound instrument called an echoendoscope is utilized. From the distal esophagus, pertinent structures visualized with the echoendoscope include the lower esophageal sphincter (LES) within the wall, the crural diaphragm, and the fundus of the stomach. The diaphragmatic crura are typically seen interposed between the distal esophageal wall and the fundus of the stomach. One aspect of this invention utilizes the visualization capabilities of ultrasound endoscopy to permit a novel device and method for treating GERD. 
     BRIEF SUMMARY OF THE INVENTION 
     Accordingly, an objective of this invention is to provide a method to reduce gastroesophageal reflux by endosonography-guided intervention. Specifically, endosonography is used to insert a ligation element through the esophageal wall, through the diaphragmatic crus and into the fundus of the stomach. This ligation element placed from the esophagus and around the angle of His may create a barrier to gastroesophageal reflux. 
     The present invention is directed to a device, system and method that, as embodied and broadly described herein, includes an implantable ligation element for fastening layers of tissue together. The ligation element has proximal and distal ends and is suitable for insertion through the esophageal wall, the crura and into the fundus of the stomach. The distal end of the ligation element can be brought from the fundus, around the gastro-esophageal flap valve and secured to the proximal end of the ligation element in the esophagus. This ligating element forms a loop that can be used to draw the tissues described together. 
     In a further aspect of the invention, a system for fastening tissue is provided. The system includes a tissue securement apparatus that can be initially positioned in the esophagus using an echoendoscope. The securement apparatus is comprised of a hollow needle with a detachable needle tip. A connecting element is positioned inside the needle and attached to the needle tip. When an inner stylet is advanced, the needle tip separates from the needle body and the needle tip with a portion of the connecting element moves apart from the needle body to reside in the fundus of the stomach. 
     In another aspect of the invention, the system for fastening tissue also includes a ligating element that can be attached to the proximal end of the connecting element once the hollow needle is removed. The ligating element may utilize a dilating element positioned at its distal end that is sized to dilate a tissue tunnel so that the ligating element may be drawn more easily through the tissue structures. 
     In still another aspect of the invention, the system may also utilize an endoscopically guided grasper to grasp the distal end of a connecting element and pull the ligating element across the esophageal wall and into the stomach. The system may also utilize a securement element that is configured to engage the proximal and distal ends of the ligating element together. This may prevent the ligating element loop from loosening. 
     In yet another aspect, the present invention includes a method of treating gastroesophageal reflux disease. In the method, a ligating element having a proximal end and a distal end is passed transorally through the esophagus to a position near the junction between the esophagus and the stomach. The distal end of the ligating element is placed through the wall of the esophagus, through a portion of the diaphragmatic crura and into the gastric fundus using ultrasonic guidance. The distal end of the ligating element is grasped in the fundus, wrapped around the gastro-esophageal flap valve and secured to the proximal end of the ligation element in the esophagus. 
     All of these embodiments are intended to be within the scope of the present invention herein disclosed. These and other embodiments of the present invention will become readily apparent to those skilled in the art from the following detailed description of he preferred embodiments having reference to the attached figures. The invention is not limited to any particular preferred embodiment(s) disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross sectional view of the esophageal-gastro-intestinal tract. 
         FIG. 2  is a view of the esophagus and stomach showing an echoendoscope placed in the distal portion of the esophagus; 
         FIG. 3  is a section view of a needle having a detachable needle tip; 
         FIG. 4  is a view similar to  FIG. 2  showing the needle tip detached from the needle body after placement through a tissue wall; 
         FIG. 5  is a view of a ligating element with an attached dilating element; 
         FIG. 6   a  is a view of a ligating element including one embodiment of a securement element; 
         FIG. 6   b  is a view of a ligating element showing an alternative embodiment of a securement element; 
         FIG. 7  is a view showing a lower esophageal wall with a delivery needle inserted into the fundus from the esophagus; 
         FIG. 8  is a view showing a gastroscope in the stomach with an extended grasper capturing the retrieval loop on the needle tip; 
         FIG. 9  is a view showing a gastroscope in the lower esophagus with the ligating element forming a loop around the gastro-esophageal flap valve and the stomach drawn up to the lower esophageal wall; 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The system and method described herein may offer improvements over the techniques currently utilized to perform endoscopic procedures. This tissue securement system has several embodiments that are intended to work together to create a novel device and method for the treatment of GERD. However these embodiments also function independently and some of the embodiments of this system may be removed and the system may still achieve its desired function. Alternatively several of these embodiments may be useful as stand alone devices. The principle elements of this system are; an echoendoscope, a delivery needle, a stylet, a needle tip, a connecting element, a ligating element and securement elements. 
       FIG. 1  is a cross sectional view of the esophageal-gastro-intestinal tract shown from the esophagus  1  to the stomach  2 . The fundus  3  forms the superior portion of the stomach  2 . The esophagus  1  enters the stomach  2  at a point below the fundus  3  forming the cardiac notch  4  and an acute angle with respect to the fundus  3  known as the Angle of His  5 . The lower esophageal sphincter (LES)  6  is an important primary sphincter that controls the movement of fluids and food into the stomach. The gastro-esophageal flap valve  7  includes a moveable portion and a more stationary portion. The moveable portion is a moveable flap that is formed at the junction of the esophagus  1  and the stomach  2 . This flap is approximately 4-5 cm long and is partially held against the opposing wall of the stomach  2  by the internal pressures of the stomach. The esophageal tract is primarily controlled by the LES  6  and the gastro-esophageal flap valve  7 . When either the LES  6  or the gastro-esophageal flap valve  7  does not close properly the condition known as Gastroesophageal Reflux Disease (GERD) can occur. It is the intent of this invention to provide a treatment method for GERD by supporting the LES  6  and the gastro-esophageal flap valve  7 . 
     A first component of the tissue securement system, the delivery needle  10 , is shown in  FIGS. 2 and 3  and is designed to be inserted through the instrumentation channel of an endoscope or preferably an echoendoscope  12 . The delivery needle  10  can be manually advanced and retracted. The proximal end of the delivery needle may include a handle (not shown) which can be secured to the inlet port of the instrumentation channel by a luer lock mechanism. The delivery needle  10  can be housed in a protective outer sheath  18  which serves to protect the instrumentation channel of an endoscope or echoendoscope from damage from the sharp needle tip and to provide support as the delivery needle  10  is advanced. The outer sheath  18  can be manually advanced to cover the length of the delivery needle  10 . 
     In one embodiment shown in  FIG. 3 , the delivery needle  10  consists of a needle body  20  which is constructed from a hollow tube and utilizes a hollow stylet  22  located coaxially inside. The delivery needle  10  is sized to fit through the working channel of an echoendoscope although this system may function equally well with larger diametric requirements. The size of the delivery needle  10  is preferably 18 to 26 gauge. More preferably the size is 19 to 23 gauge. A needle tip  24  is located near the distal end  26  of the needle body and is detachably coupled to the needle body  20 . The needle body  20  has an inner diameter  30  that provides support to the needle tip  24  during insertion. The needle tip  24  has a mating retention boss  32  located on the proximal end of the needle tip that is formed so that the needle tip  24  fits snugly inside the inner diameter  30  of the needle body  20 . Although a peg and hole arrangement is depicted in the drawings, various other features such as a tongue and groove, a bayonet and slot or other common mechanical stabilizing features could easily function with the same intended result; to hold and support the needle tip  24  in position at the end portion of the needle body  20  until the delivery needle is deployed as described later. 
     A connecting element  40  is connected to the needle tip  24  at point  41  and the connecting element  40  extends through the hollow pusher stylet  22  to the proximal end of the needle where it can be manipulated by the operator outside the patient&#39;s body. Upon advancement of the delivery needle  10  into soft tissue, the operator places tension on the connecting element  40  which firmly seats the needle tip  24  in the needle body  20 . This facilitates the introduction of the needle body  20  and needle tip  24  through tissue and into a targeted delivery site. Once at the delivery site, the tension can be released. The connecting element  40  is preferably a suture, thread, plastic filament or wire. The pusher stylet  22  extends along the length of the needle body  20  to the proximal end of the needle tip located at the retention boss  32 . 
     Once the delivery needle  10  is advanced to a point where the needle tip  24  is at the delivery site, the stylet  22  can be used to deploy the needle tip  24  and connecting element  40 . As shown in  FIG. 4 , when the stylet  22  is advanced the needle tip  24  separates from the needle body  20  and the needle tip  24  and the attached connecting element  40  are delivered to the delivery site. The stylet  22  is next withdrawn into the needle body  20  and the delivery needle  10  can be withdrawn into the protective sheath  18  inside the working channel of an endoscope or echoendoscope. The echoendoscope along with the delivery needle  10  is then withdrawn leaving behind the needle tip  24  with the connecting element  40  extending out through the patient&#39;s mouth. The needle tip  24  helps prevent inadvertently pulling out the connecting element  40  from the soft tissue as the echoendoscope  12  and the delivery needle  10  are withdrawn. The connecting element  40  can be attached to the proximal end of the needle tip at  41  or can be connected to a center portion of the tip so that the tip swivels away from the connecting element  40  further preventing inadvertent pullout of the connecting element  40 . 
     The needle tip  24  may utilize a retrieval loop  44  attached near its apex  46  as illustrated in  FIGS. 3 and 4 . The retrieval loop  44  is a small piece of string or wire that is collapsed along the side of the needle tip  24  while the needle tip  24  is inside the protective sheath  18 . The retrieval loop  44  expands once the needle tip  24  and connecting element  40  are deployed as shown in  FIG. 4 . The retrieval loop  44  may be positioned inside a groove  50  that is formed or cut into the side wall  52  of the needle tip  24 . The retrieval loop  44  may be important to guide the needle tip  24  into the working lumen of a gastroscope as the needle tip  24  and connecting element  40  are retrieved as part of the method of this application. 
     The delivery needle  10  has several potential advantages over other delivery systems that deliver T-tags, plugs or anchors. First, the working channel of a standard echoendoscope has a small diameter in the range of 2.8 mm. This small size limits the size of the needle and T-tag that can be delivered through the working channel. A T-tag may be preloaded inside the hollow core of a needle, but this requires that the T-tag be very small for the procedure. T-tags of this size are difficult to handle by the physician and may be less effective. An alternative to placing the T-tag within a needle requires multiple instrument exchanges whereby first a needle is delivered to the intended site, a guidewire is inserted through the needle lumen, the needle coaxially exchanged for a sheath over the guidewire and the guidewire removed so that a T-tag can be delivered with a pushing stylet. The delivery needle  10  described in this application facilitates a simple delivery of a 19-23 gauge needle tip that acts like a T-tag. This delivery needle can save the operator time and permit delivery of an anchor with a single instrument. 
     The system so far described is designed to deliver a connecting element  40  and needle tip  24  through soft tissue to an intended delivery site. More preferably this system is designed to deliver the connecting element  40  and the needle tip  24  through the esophageal and stomach wall for the treatment of GERD. In this position, the connecting element  40  can be used to pull another component of the system, a ligating element  60 , through soft tissue. 
     The ligating element  60  as shown in  FIG. 5  is a length of material that is suitable for long term contact with patient tissue, and is used to tie together layers of soft tissue. It may be a suture, a tie, a thread, a band, a web, a strap, a belt, an elongated piece of mesh, a wire, or a Teflon patch. It may be a single filament or may be folded or coiled up for delivery as illustrated in side “A” of  FIG. 5  and then be deployed in an unfolded or uncoiled configuration as illustrated in side “B” of  FIG. 5  once in position. It should have enough bulk to reduce the potential for pulling out of soft tissue when force is applied to the ligating element  60 . The ligating element  60  has a proximal end  62  and a distal end  64 . The distal end  64  of the ligating element  60  can be connected to the proximal end of the connecting element  40  outside the patient&#39;s body. The distal end  64  of the ligating element may have a dilating element  66  that is intended to dilate and widen the initial channel through tissue formed by the connecting element  40 . The dilating element  66  is a tapered element or bougie that has a diameter similar to the connecting element  40  at its distal end and a diameter similar to the ligating element  60  at its proximal end. It is formed or attached coaxially to the ligating element  60 . As the ligating element  60  is drawn into tissue, the dilating element  66  expands the lumen so that the ligating element  60 , which may have a larger profile, can transverse the lumen without high forces or causing clinically unacceptable tissue trauma. 
     The proximal end  62  and distal end  64  of the ligating element  60  may have securement elements  70  and  72  respectively as illustrated in  FIGS. 6   a  and  6   b . The securement elements  70  and  72  are designed to connect both ends of the ligation element  60  together so that the ligation element  60  forms a loop. The securement elements  70  and  72  may incorporate an additional feature which will permit one way slippage so that the diameter of the loop formed can be reduced but not increased. However the ligating element  60  may function equally as well without any securement elements incorporated into the ligating element  60 . By example a simple crimping ferrule or wire clip may be utilized with similar results. The securement elements  70  and  72  function similarly to a string loop secured with a slip knot that can be pulled at one end and the loop diameter reduced. As shown in  FIG. 6   a , the securement element  70  is a suture loop  74  attached to the proximal end of the ligating element  60  formed using a slip knot. The loop  74  is large enough so that a gastroscope can be introduced through the loop. As the distal end  64  of the ligating element is brought through the loop  74 , the loop reduces and secures the ligating element  60  in position. 
     Another embodiment of the securement element  70 , shown in  FIG. 6   b , has a pre formed loop  80  attached to the proximal end  62  of the ligating element  60 . The loop  80  is large enough so that a gastroscope can be introduced through the loop  80 . The dilating element  66  located near the distal end  64  of the ligating element  60  has a series of grooves  82  that are formed or cut in the side of the tapered dilating element  66 . As the dilating element  66  is brought through the loop  80 , the series of grooves  82  contact the pre formed loop  80  and the loop  80  successively moves into the recesses of the grooves. This prevents the dilating element  66  from pulling out of the loop  80  but the ligating element  60  can be successively tightened as the dilating element  66  is drawn into the loop  80 . Many other types of securement elements such as a rack and pinion, mechanical ratchet are possible and the examples illustrated here are not meant to be limiting. In fact many other suture retention apparatus are equally feasible as known to those in the art. 
     Methods of treating GERD are discussed with reference to  FIGS. 1-8 . Although the invention is described in connection with the structure shown in these figures, and in connection with treating GERD, it should be understood that the system in its broadest sense is not so limited. 
     As shown in  FIG. 7 , an echoendoscope  12  is positioned through the patient&#39;s esophagus  1  to a position near the lower esophageal sphincter (LES)  6 . Although an endoscope  12  may be used an echoendoscope is preferred so that structures and hollow spaces that are positioned behind tissue walls can be visualized. When the echoendoscope  12  is properly positioned, the working channel is directed toward the inner wall of the esophagus  100  and the delivery needle  10  is advanced. The delivery needle  10  pierces the esophageal wall  100  and is then directed through the diaphragmatic crura  106  under ultrasonic guidance and through the wall of the stomach  108  and into fundus  3 . It is important that the delivery needle  10  transverse the diaphragmatic crura  106  because is thought that this is a stable structure that will anchor the system as opposed to anchoring to soft tissue alone. Once the distal end  26  of the delivery needle is positioned in the fundus  3 , the stylet  22  is advanced to separate the needle tip  24  from the needle body  20 . The needle tip  24  with the attached connecting element  40  is deposited in the fundus  3  and the delivery needle  24  is withdrawn. The echoendoscope  12  can be withdrawn leaving behind the connecting element  40  extending from the fundus  3  to the mouth of the patient. 
     The distal end  64  of the ligating element is attached to the proximal end of the connecting element  40  outside the patient&#39;s body. As shown in  FIG. 8 , a gastroscope  112  is then inserted into the patient&#39;s mouth down the esophagus  1  and into the stomach and positioned so that the needle tip  24  and the retrieval loop  44  can be visualized. A grasper  114  is extended from the working channel of the gastroscope  112  and it grabs the retrieval loop  44  of the needle tip  24 . The needle tip  24  and connecting element  40  are pulled by the grasper  114  into the working lumen of the gastroscope. The connecting element  40  in turn pulls the ligating element  60  down the esophagus  1  through the esophageal wall  100  and into the fundus  3 . The ligating element  60  is drawn near the end of the gastroscope and the gastroscope is withdrawn from the stomach to a position near the LES  6  as shown in  FIG. 9 . When the securement elements  70  and  72  are brought into close proximity to each other, a loop  120  consisting primarily of the ligating element is formed. This loop  120  formed when the ligating element  60  transverses the esophageal wall  100 , the diaphragmatic crura  106 , and the fundus  3  of the stomach, around the gastro-esophageal flap valve  7  and back to the esophageal wall  100 . 
     An important feature of the securement elements is that the securement formed between the two ends of the ligating element is slidable so that the diameter of the loop  120  can be reduced to cinch various anatomical features together. By cinching down the loop  120 , the fundus  3  of the stomach  2  is drawn into close proximity with the esophageal wall  100 . This causes the stomach  2  to be partially wrapped around the esophagus so that esophagus  1  and stomach  2  are positioned in a method similar to a Nissen fundoplication procedure. As the internal pressure of the stomach  2  increases during digestion, the stomach applies a compressive force to the esophagus  1  that tends to reduce the internal luminal diameter of the esophagus. The compressive force reduces the likelihood of the stomach contents being able to pass through the esophagus  1 . In other words the lower esophagus functions like a properly functioning lower esophageal sphincter. 
     This invention has been described and specific examples of the invention have been portrayed. The use of those specifics is not intended to limit the invention in anyway. Additionally, to the extent that there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is my intent that this patent will cover those variations as well.