Abstract:
Suture holding devices and methods are disclosed, including devices and methods useful in performing a transoral surgical procedure, such as a posterior gastropexy procedure. A device is disclosed which can be used by a physician in a medical procedure to automatically lock and cut a suture in one motion and without the need for additional cutting instrumentation, rather than perform separate locking and cutting actions.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims priority to and incorporates by reference the following applications: U.S. Provisional Application 60/571,117 filed May 14, 2004; U.S. provisional Application 60/571,119 filed May 14, 2004; and U.S. Provisional Application 60/571,000 filed May 14, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to endoscopic suturing devices and methods, including devices and methods which may pass through or be employed in connection with the working channel of various endoscopic and ultrasound devices.  
       BACKGROUND  
       [0003]     Application of sutures in the gastrointestinal tract is required for several different types of medical procedures, for example, for transoral endoscopic valvuloplasty for gastroesophageal reflux disease (GERD), gastroplasty, fundoplication, anterior gastropexy, posterior gastropexy, suturing esophageal perforations, or closure of the esophageal side of the tracheo-esophageal fistula. Traditionally, these procedures are performed by physicians, such as gastroenterologists or surgeons, either by laparoscopy or open surgical techniques. Such procedures are invasive, as laparoscopy requires that small access incision(s) be made in the body of the patient, through which a laparoscope and other surgical enabling tools are provided, while open surgical techniques are traditionally invasive and can have complications and cause long patient recovery periods.  
         [0004]     The solution to these problems is to perform these medical procedures through the gastroesophageal tract via the mouth or other naturally occurring orifice. Already available flexible endoscopes, commonly called gastroscopes, can be provided through the gastroesophageal tract and enable illumination and visualization of tissue along the gastroesophageal tract on a video display for diagnostic purposes. These flexible endoscopes also provide an instrumentation means for applying sutures in tissue, such as in the wall of the stomach. What is needed are improved methods of providing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoid more invasive laparoscopic procedures.  
         [0005]     New endoscopic suturing methods performed through the gastroesophageal tract as an alternative to the invasive laparoscopic method of, for example, a posterior gastropexy procedure, are currently being developed. For example, suturing methods under the control of endoscopic ultrasound (EUS) are being evaluated. EUS is a procedure that combines endoscopy and ultrasound. In particular, a Mar. 14, 2003 publication authored by Fritscher-Ravens, Mosse, Mukherjee, Yazaki, Park, Mills, and Swain, entitled, “Transgastric gastropexy and hiatal hernia repair for GERD under EUS control: a porcine model,” (American Society for Gastrointestinal Endoscopy) describes how endoluminal operations for gastroesophageal reflux are currently limited by the inability of the surgeon to visualize and manipulate structures outside the wall of the gut. The publication describes a way to define the EUS anatomy of structures outside the gut that influence reflux, to place stitches in the median arcuate ligament, to perform posterior gastropexy, and to test the feasibility of crural repair, under EUS control, in pigs. More specifically, by using a linear-array EUS, the median arcuate ligament and part of the right crus were identified and punctured with a needle, which served as a carrier for a tag and suture. These were anchored into the muscle. An endoscopic sewing device was used, which allowed stitches to be placed through a 2.8-mm accessory channel to any predetermined depth.  
         [0006]     The publication also describes new methods of knot tying and suture cutting through the 2.8-mm channel of the EUS. More specifically, stitches were placed through the gastric wall into the median arcuate ligament, and one stitch was placed just beyond the wall of the lower esophageal sphincter. The stitches were tied together and locked against the gastric wall, and the surplus length of suture material was then cut and removed. While this publication describes a suitable transgastric gastropexy and hiatal hernia repair procedure, further improvements in methodology and equipment to perform such procedures would be beneficial. For example, the publication describes a process for locking and cutting the suture from inside the stomach. However, the suture requires that a separate suture cutting step, along with its associated cutting instrumentation, be available via the working channel of the endoscope. This may result in multiple passes of instrumentation back and forth through the working channel of the endoscope. What is needed is a way to both lock and cut a suture automatically with a single device and thereby simplify the medical procedure, such as a posterior gastropexy procedure.  
         [0007]     Additionally, the locking mechanism described in the publication is too large to pass through the working channel of an endoscope and, thus, it must be inserted into the patient separately from the endoscope, which again adds complexity to the medical procedure. What is needed are suture locking and cutting mechanisms that are small enough to pass through the working channel of various endoscopic and ultrasound devices (typical working channel diameter is 2.8-3.4 mm).  
       SUMMARY OF THE INVENTION  
       [0008]     Applicants recognize the desirability of providing improved methods of performing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoid more-invasive laparoscopic procedures. Applicants also recognize the desirability of providing a single mechanism for automatically locking and cutting a suture and thereby simplifying medical procedures, such as, but not limited to, a posterior gastropexy procedure; and the desirability of providing suture locking and cutting mechanisms that are small enough to pass through the working channel of various endoscopic and ultrasound devices.  
         [0009]     Certain embodiments of the present invention are directed to providing improved methods of performing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoiding more-invasive laparoscopic procedures. One embodiment of the present invention provides a device and method that allows a physician in a medical procedure to automatically lock and cut a suture in one motion and without the need for additional cutting instrumentation, rather than perform separate locking and cutting actions.  
         [0010]     In one embodiment of the invention, a suture lock assembly in combination with a lock actuating device is provided. The lock comprises an extension spring arranged between two endcaps, wherein one or more sutures are locked within the coils thereof. Extending the extension spring allows for one or more sutures to be threaded therethrough and, by relaxing the extension spring, provides a clamping action upon the sutures and a torturous path within the coils. The lock actuating device provides a cutting mechanism. Furthermore, both the suture lock assembly, in combination with a lock actuating device, are suitably small enough to pass through the working channel of various endoscopic and ultrasound devices.  
         [0011]     In another embodiment of the invention, a suture lock assembly is provided that forms a hollow body, within which a clamp device is engaged and through which one or more sutures is threaded. Depending upon the slidable position of the clamp device within the body, the suture within the clamp device is engaged to clamp the suture permanently. The suture lock assembly of this embodiment is likewise suitably small enough to pass through the working channel of various endoscopic and ultrasound devices.  
         [0012]     The various embodiments of the invention can be employed with various types of suture, including without limitation monofilament suture and braided suture. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     While the novel features of the invention are set forth with particularity in the appended claims, the invention, in all its embodiments, may be more fully understood with reference to the following description and accompanying drawings.  
         [0014]      FIG. 1A  illustrates a perspective view of a suture lock assembly in accordance with a first embodiment of the invention;  
         [0015]      FIG. 1B  illustrates a cross-sectional view of the suture lock assembly in accordance with a first embodiment of the invention;  
         [0016]      FIG. 2  illustrates a side view of an exemplary lock actuating device according to the first embodiment;  
         [0017]      FIGS. 3A and 3B  illustrate a side view and a top view, respectively, of the distal end of the lock actuating device with the suture lock assembly of the first embodiment engaged therein in the default state;  
         [0018]      FIGS. 4A and 4B  illustrate a side view and a top view, respectively, of the distal end of the lock actuating device with the suture lock assembly of the first embodiment engaged therein in the lock state;  
         [0019]      FIGS. 5A and 5B  illustrate a side view and a top view, respectively, of the distal end of the lock actuating device with the suture lock assembly of the first embodiment engaged therein in the cut state;  
         [0020]      FIG. 6  illustrates a side view of the suture lock assembly of the first embodiment engaged therein in the release state;  
         [0021]      FIG. 7  illustrates a flow diagram of an example method of using the suture lock assembly of the first embodiment in combination with the lock actuating system;  
         [0022]      FIG. 8  illustrates a perspective view of a suture lock assembly in accordance with a second embodiment of the invention.  
         [0023]      FIG. 9  illustrates a cross-sectional view of the suture lock assembly of the second embodiment in the unlocked state.  
         [0024]      FIG. 10  illustrates a cross-sectional view of the suture lock assembly of the second embodiment in the locked state.  
         [0025]      FIGS. 11A and 11B  illustrate cross section views of an alternative locking device with a one-way flap inside a tubular segment, in a loading state, and a locked state, respectively.  
         [0026]      FIGS. 12A and 12B  show a cross section view of alternative one-piece clip in a default state, and a cross section view of the one-piece clip in a locked state, respectively. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]      FIG. 1A  illustrates a perspective view of a suture lock assembly  100  in accordance with a first embodiment of the invention. Suture lock assembly  100  includes an extension spring  112  arranged between a distal endcap  114  and a proximal endcap  116 .  
         [0028]     Extension spring  112  is formed of any nontoxic, noncorrosive metal, such as stainless steel, and distal endcap  114  and proximal endcap  116  are formed of, for example, molded plastic or stainless steel. Also shown in  FIG. 1  is a suture  118  threaded first through a hole  120  in distal endcap  114  and then through multiple coils of extension spring  112 , wherein suture  118  is clamped because of the pressure of the coils and the tortuous path within the coils. Suture lock assembly  100  is not limited to a single suture  118  installed therein; a plurality of sutures  118  may be engaged within a single suture lock assembly  100 .  
         [0029]      FIG. 1B  illustrates a cross-sectional view of suture lock assembly  100  taken along line AA of  FIG. 1A . This view shows that proximal endcap  116  further includes a hollow channel  121  that runs through its center. Furthermore, hole  120  in distal endcap  114  is angled from the center of an outer end of distal endcap  114  toward the sidewall of distal endcap  114 , which thereby allows suture  118  to exit distal endcap  114  external to extension spring  112 . Distal endcap  114  and proximal endcap  116  may be insert-molded onto extension spring  112  or use other methods or procedures of providing a smooth, trauma free extension of spring coils.  
         [0030]     In operation, suture  118  is threaded first through hole  120  in distal endcap  114 ; extension spring  112  is then extended and suture  118  is threaded through multiple coils of extension spring  112 ; extension spring  112  is then relaxed, which thereby applies a tortuous path in addition to a clamping or locking action upon suture  118  between the coils thereof. The overall diameter of suture lock assembly  100  is suitably small enough to allow it to pass through the working channel of various endoscopic and ultrasound devices, which is typically between 2.8 and 3.4 mm in diameter. See Table 1 for example dimensions of suture lock assembly  100 .  
                                           TABLE 1                           Example dimensions of suture lock assembly 100                Example Dimension                            Suture lock assembly 100 overall length   0.70   in           Extension spring 112 outside diameter   0.060   in           Extension spring 112 inside diameter   0.040   in           Distal endcap 114 outside diameter   0.07   in           Distal endcap 114 length   0.15   in           Proximal endcap 116 outside diameter   0.07   in           Proximal endcap 116 length   0.125   in           Hollow channel 121 diameter   0.04   in           Hole 120 diameter   0.04   in           Hole 120 angle   45   degrees                      
 
         [0031]      FIG. 2  illustrates a side view of a lock actuating device  200 , which is exemplary only and representative of any suitable actuating device for use with suture lock assembly  100 . In this example, lock actuating device  200  includes a body  210  that has a knob  212  arranged at its proximal end for grasping by the user. Mechanically coupled to body  210  is a retract handle  214 , which has a retract handle body  216  and a retention handle  218  that is slidably arranged within retract handle body  216 . Furthermore, a compression spring  220  is mechanically coupled between a spring retainer  222 , which is coupled to knob  212 , and the proximal end of retract handle body  216 . Mechanically coupled to the distal end of retract handle body  216  is a hollow retractable sleeve  224 , within which is first arranged a hollow retention sleeve  225 , which has a retention jaw  226  at its distal end. Furthermore, arranged within retention sleeve  225  is an actuating shaft  228 .  FIG. 2  also shows that arranged within the distal end of retractable sleeve  224  is a first slot  230  that is aligned opposite a second slot  232 . Also, arranged within the distal end of retention sleeve  225  is a hole  234  that is aligned opposite a slot  236 .  
         [0032]     Actuating shaft  228  of a fixed length is mechanically coupled at one end to the distal end of spring retainer  222  while passing through spring retainer  222 . Actuating shaft  228  passes through a hollow channel within retract handle body  216 , then passes through the hollow channel of retention jaw  226  within retractable sleeve  224 . The tip of actuating shaft  228  extends through an opening at the distal end of retention jaw  226  within retractable sleeve  224 . Using retract handle  214  and retention handle  218 , retractable sleeve  224  and retention sleeve  225  are slidable along the length of actuating shaft  228 . As a result, the relative axial position of retractable sleeve  224 , retention jaw  226 , and actuating shaft  228  may vary one to another under user control. Lock actuating device  200  may include well-known mechanical methods and elements (not shown) for holding retractable sleeve  224  and retention jaw  226  at various positional states.  
         [0033]     The operation of suture lock assembly  100  in combination with lock actuating device  200  for automatically locking and cutting a suture includes a sequential transition from a default state (i.e., undeployed state) to a lock state, a cut state and, finally, a release state (i.e., deployed state), as described in reference to  FIGS. 3A, 3B ,  4 A,  4 B,  5 A,  5 B,  6 , and  7 . Additionally,  FIGS. 3A, 3B ,  4 A,  4 B,  5 A,  5 B, and  6  show suture lock assembly  100  in use and, therefore, it includes suture  118 , which runs through the center of suture lock assembly  100  and approximates a first tissue  122  and a second tissue  124 . Suture  118  is anchored to second tissue  124  with a T-tag  126 , which is a well-known medical device for anchoring a suture into body tissue.  
         [0034]      FIGS. 3A and 3B  illustrate a side view and a top view, respectively, of the distal end of lock actuating device  200  with suture lock assembly  100  engaged therein in the default state, which is described as follows.  
         [0035]     Default state: In the default or undeployed state, extension spring  112  is extended suitably to allow suture  118  to slide freely through its coils. This is accomplished by the physician&#39;s passing actuating shaft  228  through hollow channel  121  of proximal endcap  116 , then through the center of extension spring  112 , until the tip of actuating shaft  228  abuts the inner surface of distal endcap  114 . By using retention handle  218 , which is attached to the proximal end of retention sleeve  225 , the physician extends retention jaw  226  to allow it to grip proximal endcap  116  and then pull proximal endcap  116  into the tip of retractable sleeve  224 , as shown in  FIGS. 3A and 3B , which thereby extends extension spring  112 , relative to the tip of actuating shaft  228 . The distance between the tip of actuating shaft  228  and the tip of retractable sleeve  224  is predetermined to suitably extend extension spring  112 . Additionally, suture  118  is threaded first through hole  120  in distal endcap  114 , then within the extended coils of extension spring  112  is wrapped multiple times around actuating shaft  228 , through first slot  230  of retractable sleeve  224 , through hole  234  of retention sleeve  225 , passes around actuating shaft  228 , through slot  236  of retention sleeve  225  and, finally, through second slot  232  of retractable sleeve  224 .  
         [0036]      FIGS. 4A and 4B  illustrate a side view and a top view, respectively, of the distal end of lock actuating device  200  with suture lock assembly  100  engaged therein in the lock state, which is described as follows.  
         [0037]     Lock state: In the lock state, extension spring  112  is relaxed, which allows its coils to clamp against suture  118  and thereby prevent suture  118  from sliding freely between the coils of extension spring  112 . By using retention handle  218 , which is attached to the proximal end of retention sleeve  225 , the physician extends retention jaw  226  while gripping proximal endcap  116  in a direction toward distal endcap  114  and while maintaining the relative distance between the tip of actuating shaft  228  and the tip of retractable sleeve  224 , as set in the default state. Although the relative position of hole  234  and slot  236  to first slot  230  and second slot  232 , respectively, is changed, suture  118  is intact and passing freely through first slot  230  of retractable sleeve  224 , through hole  234  of retention sleeve  225 , passes around actuating shaft  228 , through slot  236  of retention sleeve  225 , and through second slot  232  of retractable sleeve  224 , as shown in  FIGS. 4A and 4B .  
         [0038]      FIGS. 5A and 5B  illustrate a side view and a top view, respectively, of the distal end of lock actuating device  200  with suture lock assembly  100  engaged therein in the cut state, which is described as follows.  
         [0039]     Cut state: In the cut state, the relative distance between the tip of actuating shaft  228  and the tip of retention jaw  226  is maintained, as set in the lock state. By using retract handle  214 , which is attached to the proximal end of retractable sleeve  224 , the physician retracts tip of retractable sleeve  224  in a direction away from the tip of retention jaw  226 , which causes the position of hole  234  and slot  236  within retention sleeve  225  to change, relative to first slot  230  and second slot  232 , respectively, such that suture  118  within hole  234  is cut as hole  234  passes underneath the edge of first slot  230 , which has a ground edge suitable for cutting suture  118 .  
         [0040]      FIG. 6  illustrates a side view of suture lock assembly  100  in the release state, which is described as follows.  
         [0041]     Release state: In the release state, the physician manipulates the grasp of retention jaw  226  and proximal endcap  116  is released, which allows all instrumentation, such as lock actuating device  200  and the endoscope, as well as the surplus length of suture  118 , to be removed. Extension spring  112  remains relaxed and, thus, the locking action upon suture  118  is maintained indefinitely within the patient.  
         [0042]     In an alternative embodiment, rather than wrapping the suture  118  multiple times around shaft  228  within the extended coils of spring  112 , the suture  118  can be manually threaded through or otherwise positioned between the extended coils, such as in a serpentine fashion, so that the coils hold the suture when the coils are permitted to close together. Such manual positioning of the suture through the coils may be employed if the shaft  228  is not employed or is otherwise not positioned within the spring  112  when the suture is positioned with respect to the coils of spring  112 .  
         [0043]      FIG. 7  illustrates a flow diagram of an example method  700  of using suture lock assembly  100  in combination with lock actuating device  200  in accordance with the invention. More specifically, method  700  provides an example of a posterior gastropexy procedure that uses suture lock assembly  100  of the present invention. The use of suture lock assembly  100  is not limited to a posterior gastropexy procedure; suture lock assembly  100  may be used in any of various, similar medical procedures. Furthermore, method  700  is not limited to a single suture  118  installed within suture lock assembly  100 ; a plurality of sutures  118  may be engaged within a single suture lock assembly  100 .  
         [0044]     At step  710 , a physician passes an EUS endoscope through a patient&#39;s mouth and esophagus and into the stomach. Example EUS endoscopes include endoscope model GF-UC160P-AT8 manufactured by Olympus Europe (Hamburg, Germany) and endoscope model EG-3630U manufactured by Pentax Medical Company (Orangeburg, N.Y.). The working channel of the EUS endoscope is preloaded with a standard EUS needle, such as is manufactured by Wilson-Cook (Winston-Salem, N.C.), that serves as a carrier for a tag and suture, such as T-tag  126  and suture  118 . Suture  118  may run either through the needle or outside the needle, but still inside the working channel of the EUS endoscope.  
         [0045]     At step  712 , under the guidance of the EUS endoscope, the physician locates and identifies structures outside the stomach wall and selects a fixation point, such as the median arcuate ligament.  
         [0046]     At step  714 , under the guidance of the EUS endoscope, the physician pushes the EUS needle, which is carrying T-tag  126  and suture  118 , through the stomach wall, which is represented by first tissue  122  in  FIGS. 3A, 3B ,  4 A,  4 B,  5 A,  5 B, and  6 .  
         [0047]     At step  716 , under the guidance of the EUS endoscope, the physician deploys and affixes T-tag  126 , with suture  118  attached thereto, to the fixation point, such as to the median arcuate ligament, which is represented by second tissue  124  in  FIGS. 3A, 3B ,  4 A,  4 B,  5 A,  5 B, and  6 .  
         [0048]     At step  718 , the physician withdraws the EUS endoscope and associated instrumentation from the patient, but leaves a length of suture  118  still threaded through the patient&#39;s gastroesophageal tract and anchored to second tissue  124  (e.g., median arcuate ligament). The length of suture  118  extends out of the patient&#39;s mouth and is accessible to the physician.  
         [0049]     At step  720 , the physician threads the length of suture  118  that is extending out of the patient&#39;s mouth into the distal end and out of the proximal end of the working channel of a standard endoscope that has a standard vision system (i.e., not an EUS endoscope).  
         [0050]     At step  722 , while holding tension on suture  118 , the physician passes the endoscope through the patient&#39;s mouth and esophagus and into the stomach. A length of suture  118  is left extending out of the proximal end of the working channel of the endoscope and is accessible to the physician.  
         [0051]     At step  724 , the physician loads suture lock assembly  100  into the distal end of lock actuating device  200  and sets suture lock assembly  100  into the default state, as described in reference to  FIGS. 3A and 3B .  
         [0052]     At step  726 , with suture lock assembly  100  in the default state and loaded into lock actuating device  200 , the physician first threads the length of suture  118  that is extending out of the proximal end of the endoscope through hole  120  in distal endcap  114 , then within the extended coils of extension spring  112  is wrapped multiple times around actuating shaft  228 , then threaded through hole  234  of retention sleeve  225 , then threaded through first slot  230  of retractable sleeve  224 , then threaded through second slot  236  of retention sleeve  225  and, finally, threaded through second slot  232  of retractable sleeve  224 , as shown in  FIGS. 3A and 3B .  
         [0053]     At step  728 , while holding tension on suture  118 , which is extending out of second slot  232  of retractable sleeve  224 , the physician passes the suture lock assembly  100  and retractable sleeve  224  of lock actuating device  200  through the working channel of the endoscope and into the patient&#39;s stomach. Suture lock assembly  100  is sliding freely along suture  118  in the default state, until distal endcap  114  is firmly abutted against the inside of the stomach wall, which is represented by first tissue  122  in  FIGS. 3A, 3B ,  4 A,  4 B,  5 A,  5 B, and  6 .  
         [0054]     At step  730 , having determined that the desired geometry change between the stomach and the median arcuate ligament (represented by first tissue  122  and second tissue  124 ) is achieved and while continuing to hold tension on suture  118 , the physician sets suture lock assembly  100  into the lock state by using retention handle  218 , as described in reference to  FIGS. 4A and 4B , which causes the coils of extension spring  112  to relax and create a torturous path and, thus, clamp against suture  118 , as shown in  FIGS. 4A and 4B .  
         [0055]     At step  732 , having secured suture lock assembly  100  against first tissue  122  with suture  118 , the physician sets suture lock assembly  100  into the cut state by using retract handle  214 , as described in reference to Figures SA and  5 B, which causes suture  118  to be cut as hole  234  passes underneath the edge of first slot  230 , which has a geometry suitable for cutting suture  118 , as shown in  FIGS. 5A and 5B .  
         [0056]     At step  734 , having secured suture lock assembly  100  against first tissue  122  and having cut suture  118 , the physician releases retention jaw  226  from proximal endcap  116  of suture lock assembly  100 , which allows all instrumentation, such as lock actuating device  200  and the endoscope, and the surplus length of suture  118 , to be withdrawn from the patient, while suture  118  remains firmly clamped, as shown in  FIG. 6 . Method  700  ends.  
         [0057]      FIG. 8  illustrates a perspective view of a suture lock assembly  800  in accordance with a second embodiment of the invention. Suture lock assembly  800  includes a cylindrical-shaped lock body  810  that further includes a plurality of suture channels  812  that run therethrough, and which have an associated plurality of locking holes  814  arranged on the outer surface of lock body  810 . Suture lock assembly  800  further includes a lock sleeve  816  that further includes a cavity  818  (shown in  FIGS. 9 and 10 ) within which lock body  810  is inserted. Lock body  810  further includes a first groove  824  and a second groove  826 , which are detents formed around the outer perimeter of lock body  810 . Lock sleeve  816  further includes a first locking ring  820  and a second locking ring  822 , which are raised regions protruding from the inside perimeter of cavity  818  that are sized to lock within the detents formed by first groove  824  and second groove  826  of lock body  810 .  
         [0058]     Also shown in  FIG. 8  is suture  118 , which is anchored to second tissue  124  with T-tag  126  passes through first tissue  122  and into one of the suture channels  812 , and exits lock body  810  via one of associated locking holes  814 . Only a small portion of the distal end of lock body  810  is inserted into cavity  818 , such that locking holes  814  are not within cavity  818  of lock sleeve  816 . Lock body  810  and lock sleeve  816  are formed of, for example, molded plastic or stainless steel.  
         [0059]      FIG. 9  illustrates a cross-sectional view of a suture lock assembly  800  and shows suture  118  passing through one of the suture channels  812  and existing lock body  810 .  FIGS. 8 and 9  are representative of suture lock assembly  800  in the default, unlocked state wherein one or more sutures  118  may be threaded freely through lock body  810 . In the default or unlocked state first locking ring  820  of lock sleeve  816  is engaged within second groove  826  of lock body  810 , as shown in  FIGS. 8 and 9 .  
         [0060]      FIG. 10  illustrates a cross-sectional view of a suture lock assembly  800  in a locked state wherein or more sutures  118  is threaded through lock body  810  and locked therein. More specifically, in the lock state, lock sleeve  816  is pushed over the entire length of lock body  810 , such that suture  118  is clamped between the outer surface of lock body  810  and the wall of cavity  818  of lock sleeve  816 , after which any surplus suture  118  material is cut, which leaves suture lock assembly  800  secured against first tissue  122 . In order to achieve the locked state enough force is applied to lock sleeve  816  against lock body  810  such that first locking ring  820  of lock sleeve  816  disengages from within second groove  826  of lock body  810 . In doing so, lock sleeve  816  slides upon lock body  810  until first locking ring  820  and second locking ring  822  are engaged within first groove  824  and second groove  826 , respectively, of lock body  810 , as shown in  FIG. 10 . The mechanical features of suture lock assembly  800  for coupling lock sleeve  816  to lock body  810  are exemplary only and are not limited to first locking ring  820 , second locking ring  822 , first groove  824 , and second groove  826 . Any well-known coupling method that allows a default and lock state by sliding lock sleeve  816  upon lock body  810  may be used.  
         [0061]     The overall diameter of suture lock assembly  800  is suitably small enough to allow it to pass through the working channel of various endoscopic and ultrasound devices, which is typically between 2.8 and 3.4 mm in diameter. See Table 2 for example dimensions of suture lock assembly  800 .  
                                       TABLE 2                           Example dimensions of suture lock assembly 800                Example Dimension                            Lock body 810 length    0.35 in           Lock body 810 outside diameter    0.07 in           Suture channels 812 diameter   0.015 in           Lock sleeve 816 length    0.38 in           Lock sleeve 816 inside diameter    0.07 in           Suture lock assembly 800 overall length    0.39 in           when locked                      
 
         [0062]     The method of using suture lock assembly  800 , in combination with suture  118 , T-tag  126 , first tissue  122 , and second tissue  124 , is generally the same as described in  FIG. 7 , in reference to suture lock assembly  100 , in that it is fed down the working channel of an endoscope and into, for example, a patient&#39;s stomach, in much the same manner. However, suture lock assembly  800  requires no special actuating device; instead, it may be pushed through the working channel of an endoscope with, for example, the tip of a standard catheter. Additionally, its use differs from suture lock assembly  100 , in that suture lock assembly  800  requires separate instrumentation for cutting the one or more sutures  118  engaged therein.  
         [0063]      FIGS. 11A and 11B  illustrate an alternative locking device similar in function to those previously mentioned. The locking device of  FIGS. 11A and 11B  are designed to lock onto suture  118 , when used in conjunction with the endoscope. The locking device of  FIGS. 11A and 11B  may be placed on suture  118  attached to T-tag  126 , that has been placed through first tissue  122  and second tissue  124  using the previously-described technique.  
         [0064]     This embodiment comprises a tubular sleeve  1100 , a flap  1105 , and a detent  1120 . Tubular sleeve  1100  may have an outer diameter of about 2.6 mm and an inner diameter of about 1 mm, and may be injection molded from a suitable polymer, such as polycarbonate, as a single piece or as separate pieces which are then fused together to form a unitary structure. In a resting state, flap  1105  is biased toward contact with detent  1120 . Therefore, to load suture  118  into tubular segment  1100 , an introducer  1130  may be used to create space between flap  1105  and detent  1120  as shown in  FIG. 11A . Introducer  1130  may be placed into tubular segment  1100  by pushing from a distal end  1122  of tubular segment  1100 , so that flap is moved away from detent  1120 . Suture may be placed through a central lumen  1135  of introducer  1130 , so that ultimately suture  118  is positioned within tubular segment  1100 . Introducer  1130  is then removed by pulling it out of tubular segment  1100  from a proximal end  1133 , so that introducer  1130  is not trapped between tubular segment  1100  and second tissue  124 .  
         [0065]     After introducer  1130  is removed, tubular segment  110  may be pushed along suture  118  toward second tissue  124  with a pusher  1140  especially designed for that purpose, as shown in  FIG. 11B . Tension on suture  118  acts to pull flap  1105  partially away from detent  1120  during advancement. When distal end  1122  of tubular segment  1100  reaches second tissue  124 , pusher  1140  is withdrawn and flap  1105  traps suture  118  against detent  1120  so that tubular segment  1100  is held securely in place.  
         [0066]      FIGS. 12A and 12B  show another alternative concept for locking onto suture  118 .  FIG. 12A  shows a perspective view of a clip  1200  comprising a first gripping surface  1210 , a second gripping surface  1220 , an opening  1230 , and a clasp  1240 . In a default state, clip  1200  is open as shown in  FIG. 12A , so that suture  118  can pass freely through opening  1230 . Clip  1200  may be placed on suture  118  attached to T-tag  126 , that has been placed through first tissue  122  and second tissue  124  using the previously-described technique. Clip  1200  may be placed onto suture  118  so that clasp  1280  is directed toward second tissue  124  and opening  1230  is directed toward the user. Clip  1200  may be pushed down suture  118  using a long flexible tube, such as an endoscope.  
         [0067]     To lock clip  1200  onto suture  118 , a horn  1270  including a tapered surface  1272  may be used to apply force at a proximal end of clip  1200 , so that first gripping surface  1210  mates with second gripping surface  1220  to securely hold onto suture  118 , while clasp  1280  holds clip  1200  closed. Clip  1200  may be made from any suitable polymer material, such as nylon. Clip  1200  may be injection molded as a unitary piece with a “living hinge” that biases the part to an open position in which a first gripping surface  1210  is held away from second gripping surface  1220  in a default open state or assembled from multiple pieces.  
         [0068]     While the present invention has been illustrated by description of various embodiments, it is not the intention of the applicants to restrict or limit the spirit and scope of the appended claims to such detail. Numerous other variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. It will be understood that the foregoing description is provided by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended Claims.