Patent Document

BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The invention relates to surgical instruments and methods. More particularly, the invention relates to methods and apparatus for the minimally invasive treatment of gastric ulcers using a cautery device, although it is not limited thereto.  
           [0003]    2. State of the Art  
           [0004]    Minimally invasive (also known as endoscopic) surgery is not a new technology. However, it is only in recent years that such surgery has become so widely accepted that it is used in many diverse procedures. Minimally invasive surgery typically involves the making of a small incision (5-10 mm) in the vicinity of the surgical site, the installation of a port through the incision, and the extension of an endoscope through the port to the surgical site. Alternatively, an endoscope is sometimes lubricated and inserted through a body cavity such as the rectum or esophagus.  
           [0005]    Gastrointestinal bleeding is a somewhat common and serious condition that can be fatal if left untreated. This problem has prompted the development of a number of endoscopic therapeutic approaches to achieve hemostasis, such as the injection of sclerosing agents, the attachment of mechanical hemostatic devices and contact electrocautery techniques. Mechanical hemostatic devices are typically in the form of clamps, clips, staples, sutures, etc. which are able to apply sufficient constrictive forces to blood vessels so as to limit or interrupt blood flow. Such devices are disclosed in U.S. Pat. No. 6,001,110. Electrocautery techniques involve the use of either monopolar or bipolar electrodes which are contacted to ulcerous tissue. A well known electrocautery device is disclosed in U.S. Pat. No. 5,336,222.  
           [0006]    The known clip techniques and cautery techniques are only adequate for relatively small ulcers because the clips and/or cautery probes must be delivered through the working lumen of an endoscope. In addition to optical elements which carry fiber optics to illuminate the surgical site and which deliver an image from the surgical site, the endoscope typically has two or three lumena: one or two lumen(a) for aspiration and irrigation, and one (the working lumen) through which a surgical tool may be passed. The working lumen is typically very small in size (e.g., about 3 mm in diameter), and thus the size of the tools which may be used with a typical endoscope are severely limited in size.  
           [0007]    Bleeding gastric ulcer lesions are not limited in size and are frequently too large to be effectively treated with the known mechanical and electrical techniques.  
         SUMMARY OF THE INVENTION  
         [0008]    It is therefore an object of the invention to provide methods and apparatus for the minimally invasive treatment of gastric ulcers.  
           [0009]    It is also an object of the invention to provide methods and apparatus for the minimally invasive treatment of gastric ulcers using a cautery device.  
           [0010]    It is another object of the invention to provide methods and apparatus for the minimally invasive treatment of gastric ulcers using a cautery device which is capable of treating relatively large lesions.  
           [0011]    It is a further object of the invention to provide methods and apparatus for the minimally invasive treatment of gastric ulcers using a cautery device which is usable in conjunction with existing endoscopes.  
           [0012]    In accord with these objects which will be discussed in detail below, the apparatus of the present invention includes a flexible coil having a proximal end and a distal end (as used herein proximal end means the end closest to the practitioner and distal end means the end closest to the surgical site) with a pull wire extending therethrough. An actuation device is coupled to the proximal ends of the coil and the pull wire for reciprocally moving one of the pull wire and the coil relative to the other. A pair of jaws are coupled to the distal ends of the coil and pull wire such that relative movement of the coil and pull wire causes opening and closing of the jaws. The jaws are rotatably coupled to a clevis means which is adapted to be coupled to the distal end of an endoscope. According to the invention, at least one jaw has an “open” structure, with a rim but substantially no jaw cup. The jaws are U-shaped, semi-circular, or horse shoe shaped and are provided with a cautery capability by selectively coupling the coil, the pull wire, or both to a source of cauterizing energy.  
           [0013]    According to one of the methods of the invention, the clevis is attached to the distal end of an endoscope and the distal end of the endoscope is delivered to the surgical site with the aid of the optics of the endoscope and with the jaws of the invention closed by activation of the actuation device. A grasper (used herein to denote any instrument such as a forceps, biopsy forceps, snare, suction device or other instrument for mechanically or otherwise grabbing, gripping, or retaining tissue) is inserted through the working lumen of the endoscope. The jaws of the apparatus of the invention are then opened so that the grasper is extended between the opened jaws (typically through the open structure of at least one jaw) to grasp the ulcerous tissue. The grasping instrument is withdrawn to pull the ulcerous tissue between the opened jaws. When the tissue is in place, the jaws of the present invention are closed and the cauterizing energy is activated to cauterize the ulcerous tissue and thereby hemostasis. The procedure may be repeated for treatment of other ulcerous tissue in the vicinity before the apparatus is withdrawn with the endoscope.  
           [0014]    According to the presently preferred embodiment, one of the jaws of the cautery device is coupled to the coil and the other is coupled to the pull wire, whereas both jaws are coupled to the clevis. This arrangement permits the jaws to assume two different closed positions: a first closed position wherein both jaws extend substantially parallel and adjacent to the face of the distal end of the endoscope and a second closed position where both jaws extend substantially perpendicular to the face of the distal end of the endoscope. The first closed position is preferred when moving the endoscope to and from the surgical site, and because the jaws have an open structure, the jaws do not block the optical “vision” of the endoscope.  
           [0015]    According to a further preferred aspect of the invention, the clevis is provided with upper and lower stops and the coil and pull wire are coupled to the jaws in such a way that different moment arms result. This permits the jaws to be moved from the first closed position to an open position, to the second closed position, and back to the first closed position with a single actuation device having a single linear movement.  
           [0016]    According to still another preferred aspect of the invention, the jaws are insulated from each other at their pivotal connection to the clevis so that they may be provided with bipolar cautery capability via separate connections to the coil and pull wire which are also insulated from each other.  
           [0017]    Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]    [0018]FIG. 1 is a schematic broken side elevation view in partial section and partial perspective of a first embodiment of the apparatus of the invention;  
         [0019]    [0019]FIG. 2 is a schematic distal end view of the apparatus of FIG. 1 with the jaws closed;  
         [0020]    [0020]FIG. 3 is a view similar to FIG. 2 with the jaws opened;  
         [0021]    [0021]FIG. 4 is a schematic broken side elevation view of the apparatus of FIG. 1 with the jaws opened and a grasper extended from the endoscope grasping ulcerous tissue;  
         [0022]    [0022]FIG. 5 is a view similar to FIG. 4 with the grasped tissue drawn into the jaws;  
         [0023]    [0023]FIG. 6 is a view similar to FIG. 5 with the jaws closed around the tissue;  
         [0024]    [0024]FIG. 7 is a schematic broken perspective view of a presently preferred embodiment of the jaw assembly of the invention with the jaws in a first closed position;  
         [0025]    [0025]FIG. 7 a  is a schematic distal end view of the presently preferred embodiment with the jaws in the closed position;  
         [0026]    [0026]FIG. 8 is a view similar to FIG. 7 with the jaws in an opened position; and  
         [0027]    [0027]FIG. 9 is a view similar to FIG. 8 with the jaws in the second closed position. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0028]    Turning now to FIG. 1, an apparatus  10  according to a first embodiment of the invention includes a flexible coil  12  having a proximal end  14  and a distal end  16  with a pull wire  18  extending therethrough. An actuation device  20 , described in more detail below, is coupled to the proximal end  14  of the coil and the proximal end  22  of the pull wire for reciprocally moving one of the pull wire and the coil relative to the other. A clevis  24  is coupled to the distal end  16  of the coil  12  and a pair of jaws  26 ,  28  are rotatably coupled to the clevis. The jaws  26 ,  28  are also coupled to the distal end  30  of the pull wire  18  such that movement of one of the pull wire or the coil relative to the other causes the jaws to open or close. According to one aspect of the invention, the clevis  24  is provided with an upstanding ring  32  which is adapted to attach to the distal end  2  of a conventional endoscope  3  having optical elements  4  and  5  which carry fiber optics for illumination and a lens and fiber optics for capturing an image, an irrigation/aspiration lumen  6 , and a lumen  7  which constitutes a hollow working channel for receiving an instrument. According to another aspect of the invention, the jaws  26 ,  28  are substantially larger than the working channel  7  so as to be able to cauterize relatively large ulcers.  
         [0029]    According to a preferred embodiment, the coil  12  or the pull wire  18 , or both are provided with an electrical coupling  34 ,  36 , respectively for coupling to a source of cautery current. Those skilled in the art will appreciate that when two electrical couplings are provided, the pull wire  18  will be provided with insulation so that it does not electrically contact the coil  12 . Alternatively, two electrically insulated pull wires may be mechanically coupled to the spool, but electrically coupled to different poles. It will also be appreciated that in either bipolar configuration, the jaws  26 ,  28  will be electrically insulated from each other. Certain techniques for providing electrical bipolar couplings are disclosed, e.g., in U.S. Pat. No. 5,395,369 to McBrayer et al., the complete disclosure of which is hereby incorporated herein by reference.  
         [0030]    The actuation device  20  is substantially the same as used in many conventional endoscopic biopsy forceps. It includes a shaft  38  having a distal throughbore  40 , a slot  42  in communication with the throughbore  40  and a proximal thumb ring  44 . A spool  46  having a cross member  48  is disposed over the slot  42 . The proximal end  14  of the coil  12  is coupled to the shaft  38  and the proximal end  22  of the pull wire  18  is coupled to the cross member  48  of the spool.  
         [0031]    According to another aspect of the invention, the jaws  26 ,  28  are “open” shapes (e.g. U-shaped, semi-circular, horse shoe shaped). That is, the jaws are defined by a rim but substantially no jaw cup. Thus, the jaws do not obstruct with the optical elements or lumena  4 - 7  at the distal end  2  of the endoscope  3 .  
         [0032]    Turning now to FIGS.  2 - 6 , according to one of the methods of the invention, after the clevis has been attached to the distal end of the endoscope, the jaws  26 ,  28  are closed as shown in FIG. 2 by activation of the actuation device  20 . In the closed position, the optical elements  4 ,  5  of the endoscope are not obstructed by the jaws  26 ,  28 . After the endoscope is delivered to the surgical site with the aid of the optical lumina, the jaws  26 ,  28  are opened as shown in FIG. 3. In the opened position shown in FIG. 3, neither the optical elements nor the lumina (including the working channel  7 ) of the endoscope are obstructed. As shown in FIG. 4, with the jaws open, a grasping instrument  8  such as a forceps, a biopsy forceps, a snare, a suction device, etc., is extended through the working channel  7 , through an opening in the jaw  28  and/or into a space between the opened jaws  26 ,  28 . The grasper is then actuated to grasp or retain the tissue  9  (e.g., by actuating jaws or suction), and the grasper is then partially withdrawn and/or the distal end of the endoscope is moved closer to the tissue as shown in FIG. 5 to pull the tissue between the opened jaws  26 ,  28 . Once the tissue is between the jaws of the bipolar apparatus  10 , the jaws are closed as shown in FIG. 6. According to one aspect of the invention, cauterizing energy is delivered to the jaws  26 ,  28  when the jaws are in the position shown in FIG. 6 to cauterize the tissue therebetween. The procedure may be repeated for treatment of other tissue in the vicinity before the apparatus is withdrawn with the endoscope.  
         [0033]    Referring now to FIGS. 7, 7 a ,  8 , and  9 , a second embodiment of the invention is disclosed which is substantially similar to the first embodiment but for the configuration of the clevis and the jaws (i.e., the proximal actuation mechanism is as shown in FIG. 1). In this embodiment, the clevis means  124  includes an upper ring portion  132  for coupling to the distal end  2  of an endoscope. The upper portion  132  may have an inner diameter which is substantially the same size as the outer diameter of the endoscope and cemented, press fit, or otherwise affixed to the distal end of the endoscope. Alternatively, the upper ring portion may be sized to slide over the distal end of the endoscope. The clevis means  124  also includes a lower side throughbore  133  which is dimensioned to allow the distal end of the coil to move therethrough. Jaws  126 ,  128  are rotatably coupled to pivot pins  124   a ,  124   b  of the clevis  124 . The jaws are preferably substantially semi-circular in shape as shown and are electrically isolated from each other by insulating washers  124   c   1 ,  124   c   2 ,  124   d   1 ,  124   d   2 . It should be mentioned that the clevis element, including the upper ring is preferably non-conductive. The distal jaw  126  is provided with a rotator arm  127  to which the distal end of the coil is coupled at pivot pin  127   a . The coil  112  actually has a rigid extension  116  at its distal end with a side opening which allows the pull wire  118  to make a 90° turn proximally of the distal end of the coil extension. The distal end of the rigid extension is coupled to the pivot pin  127   a . The proximal jaw  128  is provided with a rotator arm  129  to which the distal end of the pull wire  118  is coupled at hole  129   a . FIG. 7 illustrates the jaws in a first closed position. FIG. 8 shows the jaws in an open position. FIG. 9 shows the jaws in a second closed position. As shown in the Figures, the clevis means  124  is provided with a stop  125  which engages the moment arm  127  when the jaws are in the open position shown in FIG. 8 and prevents further forward movement of the jaw  126 . Similarly, the upper ring  132  has a distal face  135  which prevents backward movement of the jaw  128  beyond the position shown in FIGS. 7 and 8. According to this embodiment of the invention, the distance between the pivot pin  127   a  and the pivot pin  124   a  is slightly longer than the distance between the hole  129   a  and the pivot pin  124   a , giving the rotator arm  127  a longer moment than the rotator arm  129 .  
         [0034]    As mentioned above, the jaws  126 ,  128  are coupled via the coil and pull wire respectively to an actuator such as the actuation device  20  in FIG. 1. It should be intuitively clear that when the spool  46  of the actuator  20 , which is attached to the pull wire, is moved distally, the distal end of the pull wire moves distally relative to the distal end of the coil. However, because movement of the pull wire cannot effect rotation of the jaw  28  as it is stopped against the face of the ring  132 , the coil is effectively pulled in the proximal direction relative to the clevis means  124 , thereby causing the jaw  126  to rotate about the pins  124   a ,  124   b  which constitutes the rotation axis for both jaws. This results in the jaws assuming the position shown in FIG. 8 where the rotator arms  127  and  129  are as far apart as they can be because further movement of the jaws  126 ,  128  is limited by the stop  125  and the distal face  135 . When the spool is moved proximally, it urges proximal movement of the pull wire and distal movement of the coil. From the position of the jaws shown in FIG. 8, proximal movement of the spool will move the pull wire proximally causing the jaw  128  to move toward the jaw  126 . Jaw  126 , on the other hand, will only move slightly because it is impeded by the tissue it is grabbing. Thus, when the spool is moved proximally, the jaws will assume the position shown in FIG. 9 with the tissue (not shown) therebetween for cauterization. Further proximal movement of the spool would have no effect on the jaws but for the longer moment of rotator arm  127  as compared to rotator arm  129 . Further proximal movement of the spool urges further proximal movement of the pull wire. However, because the pull wire is now in a most proximal position, stopped by the jaws being closed, a relative proximal movement is effected only by distal movement of the coil relative to the clevis means. The longer moment arm of the jaw  126 , makes the distal movement of the coil possible. This additional movement of the coil causes the jaws to rotate about the pivots and move from the position shown in FIG. 9 to the initial closed position shown in FIG. 7. In the closed position in FIG. 7, the jaws are substantially perpendicular to the longitudinal axis of the endoscope and do not substantially block the optics or the working channel of the endoscope.  
         [0035]    As with the first embodiment, it will be appreciated that cautery current is applied to one or both of the end effectors (jaws  126 ,  128 ) via the pull wire and/or coil. Where bipolar cautery is desired, the end effectors are preferably electrically insulated relative to each other, and each end effector is provided with a different pole.  
         [0036]    According to another aspect of the invention, bipolar cauterization of the surgical site may be achieved by providing the grasping device which extends through the endoscope with one pole, and by providing one or both jaws of the external tool with a second electrical pole.  
         [0037]    It will be appreciated that the disclosed invention provides several inventive aspects. It is believed that the aspect of providing a rotatable treating member at the distal end of an endoscope without passing through a lumen of the endoscope is inventive. It is also believed that providing a cautery treatment element at the distal end of an endoscope without passing through a lumen of the endoscope is inventive. It is further believed that it is inventive to provide an arrangement of jaws (or other end effectors such as graspers, dissectors, scissors, clip appliers, staplers, etc.) and a single actuation means whereby the single actuation means can move the jaws from a first closed position to an open position and to a second closed position which is displaced from the first closed position. It is believed to be additionally inventive to provide such an arrangement whereby the single actuation means can then move the jaws back to the first closed position. It is believed that it is inventive to provide a pair of jaws at the distal end of an endoscope which are relatively large but which do not interfere with the operation of the endoscope when the jaws are opened or closed. It is believed that it is an inventive surgical procedure to pass a grasper through a pair of open jaws of a surgical tool, grasp tissue with the grasper, pull the tissue with the grasper between the open jaws and then close the jaws on the tissue. It is believed that it is inventive to provide a grasper which extends through an endoscope with a first electrical pole, and a tool external the endoscope with a second electrical pole for conducting a bipolar cautery procedure on tissue.  
         [0038]    There have been described and illustrated herein several embodiments of a surgical instrument for use with an endoscope. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while the illustrative embodiments incorporate most or all of the inventive features of the invention, it will be appreciated as described above that some of the inventive features may be applied alone or in combinations other than those of the disclosed embodiments. In addition, it will be appreciated that while particular embodiments have been shown, other embodiments of the invention can be utilized. For example, rather than providing a tool adjacent and clipped to the endoscope which utilizes a coil and a pull wire, the coil could be replaced with a tube (e.g., a hypotube), and/or the pull wire could be replaced with a rod, or a cable (metallic or otherwise). In each case, the extent of flexibility of tube and rod can be dependent upon the application in which the endoscope is used. Also, rather than providing a tool where the jaws rotate about pivot pins or axis, one jaw could be caused to rotate, pivot, or otherwise open relative to the other jaw, e.g., using an arcuate coupling such as disclosed in U.S. Pat. No. 5,389,104 to Hahnen et al., which is hereby incorporated by reference herein in its entirety. For purposes herein, all such rotation or pivoting is called “rotation”. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed.

Technology Category: 1