Abstract:
An apparatus includes an elongated member configured for transoral placement into a stomach, and a distal end effector including first and second members configured to engage stomach tissue, e.g., tissue beyond the: esophageal junction. The first and second members are movable relatively toward one another generally in a first plane, and the distal end effector is movable relative to the elongated member in a second plane generally transverse to the first plane. A third member of the distal end effector is configured to engage stomach tissue. The third member is movable in a distal direction relative to the first and second members. A tissue securement member of the apparatus is coupled to at least one of the first and second members for securing together tissue engaged thereby. The tissue securement member includes first and second parts, a suture attached to the first part, and a securing element attached to the suture and configured for engagement with the second part when the first and second members move relatively toward one another to engage tissue, to thereby secure the second part to the first part.

Description:
This application is a continuation-in-part of copending application U.S. Ser. No. 09/520,273, filed Mar. 7, 2000, entitled METHODS AND DEVICES FOR TISSUE RECONFIGURATION, hereby incorporated by reference, and copending application U.S. Ser. No. 09/519, 945, filed Mar. 7, 2000, entitled DEVICE AND METHOD FOR CORRECTION OF A PAINFUL BODY DEFECT, hereby incorporated by reference, both of which claim priority from provisional application U.S. Serial No. 60/140,492, filed Jun. 22, 1999, entitled STOMACH ELEVATOR METHOD AND DEVICE, hereby incorporated by reference. 
    
    
     BACKGROUND 
     This invention relates to methods and apparatus for reconfiguring tissue, and more particularly to reconfiguring tissue in the vicinity of the gastroesophageal junction. 
     Gastroesophageal reflux disease (GERD) is a common upper-gastrointestinal disorder in which acidic contents of the stomach flow inappropriately from the stomach into the esophagus. Backflow of gastric contents into the esophagus results when gastric pressure is sufficient to overcome the resistance to flow that normally exists at the gastroesophageal junction (GEJ) or when gravity acting on the contents is sufficient to cause flow through the GEJ. Medication, open surgical procedures, minimally invasive surgical techniques, and endoscopic techniques are known for treating GERD. 
     SUMMARY 
     According to one aspect of the invention, an apparatus includes an elongated member configured for transoral placement into the stomach, and a distal end effector including first and second members configured to engage stomach tissue, e.g., stomach tissue beyond the esophageal junction. The first and second members are movable relatively toward one another generally in a first plane, and the distal end effector is movable relative to the elongated member in a second plane generally transverse to the first plane. 
     Embodiments of this aspect of the invention may include one or more of the following features. 
     The distal end effector includes a third member configured to engage stomach tissue. The third member is movable in a distal direction relative to the first and second members. The third member includes a tissue engaging portion, e.g., a coil having a tissue penetrating tip. 
     The apparatus includes a tissue securement member for coupling to at least one of the first and second members for securing together tissue engaged thereby. The tissue securement member includes a first part for coupling to the first member for engagement with a first tissue section, a second part for coupling to the second member for engagement with a second tissue section to be secured to the first tissue section, a suture attached to the first part, and a securing element attached to the suture and configured for engagement with the second part when the first and second members are moved relatively toward one another to engage the first and second tissue sections, thereby to secure the second part to the first part. The securing element is configured for deployment from the first member, and the first member includes a deploying element for deploying the securing element from the first member. The first member includes tissue piercing elements defining a channel for receiving securing elements. 
     The second plane is generally perpendicular to the first plane. The distal end effector is configured for movement between a first position generally aligned with the elongated member and a second position in which the distal end effector has moved in the second plane out of alignment with the elongated member. A cable actuatable from a proximal end of the apparatus and coupled to the distal end effector moves the distal end effector in the second plane. A cable actuatable from the proximal end of the apparatus and coupled to the distal end effector moves the first and second members generally in the first plane. 
     The elongated member defines a channel for receiving an endoscope. 
     According to another aspect of the invention, a method includes advancing an apparatus including an elongated member transorally into the stomach. The apparatus includes a distal end effector having first and second members configured to engage stomach tissue. The first and second members are movable relatively toward one another generally in a first plane. The method includes then moving the distal end effector relative to the elongated member in a second plane generally perpendicular to the first plane to position the first and second members for engagement with the tissue. 
     Embodiments of this aspect of the invention may include one or more of the following features. 
     The first and second members are moved relatively toward one another in the first plane to engage tissue, e.g., stomach tissue beyond the esophageal junction. Moving the first and second members engages a first tissue section with a first securing part and a second tissue section with a second securing part. The first securing part includes a suture attached thereto and a securing element attached to the suture. The method includes moving the securing element into engagement with the second securing part to secure the second securing part to the first securing part. Moving the first and second members causes tissue piercing elements of the first member to pierce tissue. Securing elements are deployed through the tissue piercing elements. 
     The method further includes piercing the tissue with a third member of the distal end effector prior to engaging the tissue with the first and second members. 
     The instrument and method of the invention advantageously provide an endoscopic approach to treating GERD that does not require the surgical formation of portals to access the GEJ. The procedure can be performed as an outpatient procedure done under sedation, without general anesthesia being required. The procedure can be performed by gastroenterologists rather than a surgeon, and takes less time, has fewer complications and side-effects and has lower overall procedure costs than surgical methods. The procedure recreates or augments the natural anatomy, and is easily reversible. 
     Other features, objects, and advantages of the invention will be apparent from the following detailed description, and from the claims. 
    
    
     DESCRIPTION OF DRAWINGS 
     FIG. 1 is a diagrammatic representation of an instrument in use to reconfigure tissue in the vicinity of the gastroesoplageal junction of the stomach; 
     FIG. 2 shows a tissue fixation device deployed by the instrument of FIG. 1 in use to secure a bulge formed in the tissue; 
     FIG. 3A is an illustration of the instrument of FIG. 1; 
     FIG. 3B shows a proximal end of the instrument; 
     FIG. 3C shows the working channels in a shaft of the instrument; 
     FIG. 3D is an illustration of a coil assembly of the instrument; 
     FIG. 4A is a top view of a distal end of the instrument, shown with first and second jaw members in an open position; 
     FIG. 4B shows the distal end of the instrument located off-axis relative to a shaft of the instrument; 
     FIG. 5 is a side view of the distal end of the instrument, turned 90 degrees relative to FIG. 4A; 
     FIG. 6A is an illustration of a first part of the tissue fixation device of FIG. 2; 
     FIG. 6B is an illustration of the first jaw member with the first part of the tissue fixation device mounted to the jaw member; 
     FIG. 7 is an illustration of the second jaw member; 
     FIG. 8 is an illustration of the tissue fixation device of FIG. 2; 
     FIGS. 9A-9F show the instrument of FIG. 1 in use; and 
     FIG. 10 is an illustration of tissue secured with the tissue fixation device of FIG.  2 . 
    
    
     DETAILED DESCRIPTION 
     Referring to FIG. 1, an instrument  700  for reconfiguring stomach tissue, e.g., stomach tissue in the vicinity of the gastroesophageal junction (GEJ)  702 , such as tissue  704  of the lesser curvature of the stomach, is shown. The GEJ is the region of transition from the esophagus to the stomach. The lesser curvature of the stomach is a portion of the stomach located beyond the GEJ. Instrument  700  includes an elongated shaft  710  dimensioned to permit transoral access,to the stomach, and a tissue manipulator  712  for manipulating stomach tissue. Positioned within a lumen  714  defined by shaft  710  is a standard GI endoscope  715  providing visual guidance of the reconfiguring procedure. Instrument  700  is particularly adapted for treating GERD. Using instrument  700 , as described below, a bulge, plication or tissue wrap is formed in the vicinity of gastroesophageal junction  702  to reduce reflux of stomach fluids into the esophagus. 
     Tissue manipulator  712  has an elongated cable assembly  716  housed within lumen  714  of shaft  710 , and a distal end effector  718  actuated to perform the various steps in the tissue reconfiguring procedure by cable assembly  716 . End effector  718  includes first and second jaw members  720 ,  722  which engage tissue  704 . Cable assembly  716  includes first and second cable pairs  724   a ,  724   b , and  726   a ,  726   b  for moving jaws  720 ,  722  relatively toward and away from one another, respectively, in a first plane, and a third cable  728  for moving end effector  718  relative to shaft  710  in a second plane generally transverse to, and preferably perpendicular to, the first plane, as described further below. During insertion into the stomach, end effector  718  is aligned with shaft  710  (as shown in FIG.  3 A). Once positioned in the stomach, cable  728  is actuated to articulate end effector  718  out of alignment with shaft  710  (as shown in FIG.  1 ). 
     Cable assembly  716  includes a spring beam  784 , formed from, e.g., stainless steel, extending into shaft  710 . End effector  718  is attached to beam  784  at a distal end  785  of beam  784 . Beam  784 , in its rest state, is biased toward a straight alignment. Pulling cable  728  bends beam  784 . When cable  728  is released, beam  784  returns toward the straight alignment. 
     Referring also to FIG. 2, mounted to first jaw  720  is a first part  732  of a tissue securement member, e.g., a fixation device  730 , and mounted to second jaw  722  is a second part  734  of tissue fixation device  730 . As described further below, after jaws  720 ,  722  engage tissue  704  and manipulate the tissue in a wrapping action to create a bulge  736  in, e.g., the lesser curvature of the stomach, tissue fixation device  730  is deployed to secure the engaged tissue together. Cable assembly  716  includes a fourth cable  737  for deploying fixation device  730 , as described further below. 
     End effector  718  further includes a tube  738  and a third tissue engaging member, e.g., a coil  740 , received within tube  738 , for purposes described below. Coil  740  is housed within an overtube  742 , and coil  740  and overtube  742  can be moved axially proximally and distally relative to jaws  720 ,  722 , along the axis, A, of cable assembly  716 . Coil  740  can be rotatably advanced into tissue. 
     Referring to FIG. 3A, instrument  700  has, at its proximal end  745 , a handle  743  with a control knob  744  for controlling cables  724   a ,  724   b ,  726   a ,  726   b  to close and open jaws  720 ,  722 , and a control knob  746  for controlling cable  728  to move end effector  718 . Handle  743  includes a port  748  through which coil  740  and overtube  742  can be introduced into shaft lumen  714 , and a pull-knob  750  for deploying tissue fixation device  730 , as described below. As shown in FIG. 3B, handle  743  defines a channel  752  through which endoscope  715  is introduced into shaft lumen  714 . 
     Referring to FIGS. 1 and 3C, which shows the working channels in shaft  710  for receiving the various cables, overtube  742  and endoscope  715 , within lumen  714  of shaft  710  are cable housings  760   a ,  760   b  defining channels  762   a ,  762   b  in which cables  724   a ,  724   b  for closing jaws  720 ,  722  are received, and cable housings  764   a ,  764   b  defining channels  766   a ,  766   b  in which cables  726   a ,  726   b  for opening jaws  720 ,  722  are received. Within lumen  714  are also a cable housing  768  defining a channel  770  in which cable  728  for bending end effector  718  is received, and a cable housing  772  defining a channel  774  in which cable  737  for deploying fixation device  730  is received. Coil  740  and overtube  742  are received in a channel  778  defined in a coil housing  776  in lumen  714 . Housing  776  extends from port  748  to tube  738 . As shown in FIG. 3D, coil  740  has a tissue penetrating tip  741  and a distal section  740   a  having a looser wound coil than the remainder of coil  740 . Endoscope  715  is received in a channel  782  defined in an endoscope housing  780  in lumen  715 . 
     Spring beam  784  is located generally between cable housing  776  and endoscope housing  780 , and extends about 4 inches into shaft  710  from the distal end of the shaft where beam  784  is mounted to shaft  710  by, e.g., silicone adhesive/sealant. The various cable housings and spring beam  784  do not move relative to shaft  710  and handle  743 . It is the movement of the cables within the cable housings that actuate end effector  718 . Shaft  710  is preferably formed from, e.g., heat-shrink tubing. 
     Referring again to FIG. 3A, end effector  718  has a length, L 1 , of about 2 inches, cable assembly  716  extends axially by a length, L 2 , of about 2.5 inches from shaft  710 , shaft  710  has a length, L 3 , of about 23.5 inches, and handle  743  has a length, L 4 , of about 5 inches. Cable assembly  716 , spring beam  784 , and shaft  710  have the necessary flexibility to permit transoral placement of instrument  700  into the stomach. The length, L 1 , of relatively rigid end effector  718  is minimized to ensure the necessary flexibility of instrument  700  is maintained. The distance that cable assembly  716  extends axially from shaft  710  is selected to cantilever beam  784  permitting the desired bending of end effector  718  relative to shaft  710  to position jaws  720 ,  722  against the inner surface of the stomach in the vicinity of the GEJ. 
     Distal end effector  718  is sized to fit through a 12-16 mm diameter channel (corresponding to the diameter of the esophagus) and shaft  710  has an outer diameter of about 12 to 16 mm to enable transoral passage of instrument  700  into the stomach. Scope channel  782  has a diameter of either about 8 mm or 10 mm. An 8 mm diameter scope channel allows passage of 7.9 mm pediatric gastroscope, and a 10 mm diameter scope channel allows passage of a 9.8 mm adult gastroscope. Channel  778  has a diameter of about 2-3 mm for receiving cable  742 . 
     Distal end effector  718  is shown in more detail in FIGS. 4A and 4B. End effector  718  includes a central mount  800  defining a slot  801 . Spanning slot  801  and supported by mount  800  is a pin  803  to which  720 ,  722  are pivotally mounted. Central mount  800  also houses two pulleys  802  over which cables  724   a ,  724   b  are respectively passed for closing jaws  720 ,  722 . Cables  724   a ,  724   b  terminate at points  804 ,  806  on jaws  720 ,  722 , respectively. Cables  726   a ,  726   b  for opening jaws  720 ,  722  terminate at points  808 ,  810  on jaws  720 ,  722 , respectively, proximal of points  804 ,  806 . Tube  738  of end effector  718  for receiving coil  740  and overtube, 742  is attached to mount  800 , and cable  728  for bending end effector  718  terminates at point  811  on tube  738 . 
     Pulling cables  724   a ,  724   b  proximally moves jaws  720 ,  722  toward one another generally in a first plane (in the plane of the paper in FIG.  4 A). Pulling cables  726   a ,  726   b  proximally moves jaws  720 ,  722  away from one another generally in the first plane. Pulling cable  728  proximally bends beam  784  moving end effector  718  in a second plane (out of the plane of the paper in FIG. 4A) generally perpendicular to the first plane. 
     Referring also to FIG. 5, jaw  720  includes two guide tubes  816   a ,  816   b  and a slider  812  including two push rods  814   a ,  814   b  guided within tubes  816   a ,  816   b , respectively. Slider  812  is mounted to jaw  720  to slide relative to jaw  720 . Tubes  816   a ,  816   b  curve about jaw  720  to terminate in tissue penetrating tips  818   a ,  818   b  (FIG.  6 B), respectively. Push rods  814   a ,  814   b  can be formed from molded plastic such as polyethylene or polypropylene or as a braided stainless steel cable to provide the flexibility to follow the curve of tubes  816   a ,  816   b . Cable housing  772  is attached to slider  812  and cable  737  terminates at a fixed point  739  on jaw  720 . Actuation of cable  737  pushes slider  812  distally, as described below. 
     First part  732  of tissue fixation device  730  is shown in more detail in FIGS. 6A and 6B. First part  732  of tissue fixation device  730  defines through holes  820   a ,  820   b  (FIG.  6 A), and part  732  is loaded onto jaw  720  with tips  818   a ,  818   b  received in through holes  820   a ,  820   b , respectively. Connected to part  732  with a suture  822  are two securing elements, e.g., bars  824   a ,  824   b . Each bar  824   a ,  824   b  defines two through holes  826   a ,  826   b . Suture  822  is threaded through holes  826   a ,  826   b  of the bars and through holes  820   a ,  820   b  of part  732 , and is tied together forming a knot  823  to secure bars  824   a ,  824   b  to part  732 . Tubes  818   a ,  818   b  each define a channel  827  for receiving one of bars  824   a ,  824   b , and a slot  828  communicating with channel  827  for receiving suture  822  therethrough. 
     Referring particularly to FIGS. 4B and 7, jaw  722  has a distal member  830  defining a slot  832  for receiving second part  734  of fixation device  730 , and slots  834   a ,  834   b  for receiving tissue penetrating tips  818   a ,  818   b . Second part  734  of fixation device  730  defines through holes  836   a ,  836   b  for receiving tips  818   a ,  818   b . When jaws  720 ,  722  are closed, tips  818   a ,  818   b  pass through slots  834   a ,  834   b  and holes  836   a ,  836   b . Actuation of fixation device deployment cable  737  after closing jaws  720 ,  722  pushes slider  812  and push rods  814   a ,  814   b  distally, advancing bars  824   a ,  824   b  out of tissue penetrating tips  818   a ,  818   b , and locating bars  824   a ,  824   b  on the far side  838  of second part  734  of fixation device  730 , as shown in FIG.  8 . 
     Referring to FIGS. 9A-9F, in use, under endoscopic guidance, the physician advances instrument  700  transorally to position end effector  718  in the stomach. During advancement into the stomach, end effector  718  is generally aligned along the axis of shaft  710 , as shown in FIG.  9 A. The physician then turns control knob  746  to pull cable  728  proximally, thereby bending beam  784  moving end effector  718  out of alignment with shaft  710  to the position shown in FIG.  9 B. By then turning control knob  744  to pull cables  726   a ,  726   b , jaws  720 ,  722  are pivoted about pins  803  to the open position shown in FIG.  9 C. 
     The physician then advances coil  740  and overtube  742  by pushing the coil and overtube distally in channel  778  advancing coil  740  and overtube  742  out of tube  738  and into contact with stomach tissue, preferably stomach tissue beyond the gastroesophageal junction, as shown in FIG.  1 . With overtube  742  pressing against the tissue to stabilize the tissue, the physician rotates coil  740  while applying slight distal pressure to advance the coil into the tissue, as shown in FIG.  9 D. Coil  740  and overtube  742  are then pulled proximally to pull tissue between jaws  720 ,  722 . Jaws  720 ,  722  are then closed by turning control knob  744  to pull cables  724   a ,  724   b  proximally, as shown in FIG.  9 E. The turning of the control knob can also be the action that pulls coil  740  and overtube  742  proximally, ensuring that coil  740  and overtube  742  are positioned out of the way of the closing of the jaws. A lockout can be incorporated to prevent the jaws from closing if coil  740  and overtube  742  are not in their proximal position. 
     The closing of the jaws places parts  732 ,  734  of fixation device  730  in contact with two tissue sections, e.g., against two spaced tissue surfaces in the stomach, and causes tissue penetrating tips  818   a ,  818   b  to penetrate through the tissue and into holes  836   a ,  836   b  in second part  734  of fixation device  730 . To deploy fixation device  730 , the physician pulls cable  737  proximally removing slack from cable  737 . Because cable housing  772  is of fixed length and is non-movably attached to the handle, removing slack from cable  737  causes cable housing  772  to move distally, advancing slider  812  to push t-bars  824   a ,  824   b  out of tissue penetrating tips  818   a ,  818   b , as shown in FIG.  9 F. 
     The physician then opens the jaws, disengages jaw  722  from second part  734 , returns the distal end effector to its original position generally aligned with shaft  710 , closes the jaws and removes instrument  700 . FIG. 10 shows a cross-section of the tissue with fixation device  730  in place securing bulge  736 . 
     Other embodiments are within the scope of the following claims. 
     For example, rather than a coil  740 , alternative tissue penetrating or grasping elements such as a T-bar suture or two small grasping jaws can be employed. Instrument  700  can be used without the third tissue, engaging member.