Abstract:
A surgical instrument for applying a fastener to tissue. The fastener includes a male component including a base having a hole, a needle receivable in the hole, and a female component including a base and a recess for receiving the needle. The instrument includes a shaft, a first jaw pivotally mounted on the shaft including a receiver for holding the base one component, and a second jaw statically mounted on the shaft including a receiver for releasably holding the base the other component. The first jaw is moveable between an open position and a closed position. The first and/or second jaw includes a channel for slideably receiving a needle. The instrument includes a mechanism for moving the first jaw between the open and closed positions and an ejector for driving the needle through the hole in the male component, through tissue and into the recess of the female component.

Description:
BACKGROUND 
       [0001]    This invention generally relates to a surgical instrument, and more particularly to an instrument for applying a fastener to tissue of a patient. 
         [0002]    Gastroesophageal reflux disease or persistent heartburn is caused by an improper relaxation of the lower esophageal sphincter, allowing acidic stomach contents to travel into the esophagus. If left untreated, chronic reflux may cause esophageal stricture, bleeding ulcers, perforation, and scarring. Continued reflux may lead to Barrett&#39;s esophagus, involving changes in the esophageal cells and possibly leading to cancer. Antacids and proton pump inhibitors are initially used to treat this condition. If these treatments are unsuccessful, surgical intervention is often recommended. 
         [0003]    One interventional surgical method is known as Nissen fundoplication. This procedure involves wrapping a fundus of the stomach around the lower end of the esophagus and fastening it in place to make the lower esophageal sphincter less compliant. Traditionally, this procedure was accomplished by open surgery using sutures to secure the plicated fundus of the stomach around the esophagus without penetrating the stomach. More recently, laparoscopic Nissen procedures have been used. In some laparoscopic procedures, surgical fasteners are used with an endoscopic applicator. Several different fastener designs have been developed. Some of these designs include a two piece fastener. A first of these pieces, a male component, includes a base having two straight elongate needles extending perpendicularly outward from the base generally parallel to each other. A second piece, a female component, includes a receiver element having openings positioned for receiving the needles of the first piece and a lock for holding the needles in place once received in the openings. In use, tissue is gathered, the needles of the first piece are pushed through the gathered tissue and the openings of the second piece to hold the tissue and fastener in place. 
         [0004]    Various applicators are used to apply the fastener to the tissue. One applicator includes an elongate shaft having two jaws pivotally attached to its end. The jaws include receptacles for holding the first and second pieces of the fastener. The jaws push the needles of the first piece through the gathered tissue and the openings of the second piece to hold the tissue and fastener in place. As will be appreciated by those skilled in the art, because both jaws are pivotally attached to the shaft, both pieces of the fastener sweep through arcs as the jaws pivot to pierce the tissue and push the needles into the corresponding openings. As a result of the fastener pieces sweeping through arcs, both fastener pieces move relative to the tissue, making precise placement of the fastener in the tissue difficult. Even when the needles engage the tissue, the folded tissue can move relative to the female fastener component before the fastener components are fastened together. Thus, there is a need for an applicator that reduces the opportunity for the tissue to move as the fastener is applied. 
       BRIEF SUMMARY 
       [0005]    The present invention relates a surgical instrument for applying a fastener to tissue of a patient. The fastener comprises a male component including a base having at least one hole therein, a needle slideably receivable in the hole, and a female component including a base and a recess for receiving a leading end of the needle of the male component. The instrument comprises an elongate shaft having a working end and a grip end opposite the working end. A first jaw is pivotally mounted on the working end of the elongate shaft. The first jaw includes a receiver for releasably holding the base of one of the male component and the female component. A second jaw is statically mounted on the working end of the elongate shaft. The second jaw includes a receiver for releasably holding the base of another of the male component and the female component. The first jaw is pivotally moveable between an open position in which the first jaw is sufficiently spaced from the second jaw so that tissue can be received between a female component held in the corresponding jaw and a male component held in its corresponding jaw of the instrument, and a closed position in which the opening of the male component is aligned with the recess of the female component. The first jaw and/or the second jaw includes a channel for slideably receiving a needle therein. The channel includes an opening in a face of the receiver of the corresponding jaw. The instrument also comprises a mechanism operatively connected to the first jaw for moving the first jaw between the open position and the closed position. Further, the instrument includes an ejector for driving the needle through the opening in the face of the receiver, through the hole in the base of the male component, through tissue held between the first jaw and the second jaw, and into the recess of the female component. 
         [0006]    In another aspect, the present invention includes a surgical instrument for applying a fastener to tissue of a patient. The fastener comprises a male component including a base having at least one hole therein, a needle slideably receivable in the hole, and a female component including a base and a recess for receiving a leading end of the needle of the male component. The instrument comprises an elongate shaft having a working end and a grip end opposite the working end. Further, the instrument includes a stationary jaw statically mounted on the working end of the shaft including a receiver for holding one of the male component and the female component. In addition, the instrument includes a pivoting jaw mounted on the working end of the elongate shaft adjacent the stationary jaw including a receiver for releasably holding another of the male component and the female component. The pivoting jaw selectively pivots between an open position in which tissue can be received between the jaws and a closed position in which the hole of the male component is aligned with the recess of the female component. At least one of the stationary jaw and the pivoting jaw includes an ejector for driving the needle through the hole in the male component base, through tissue between the jaws, and into the recess of the female component. 
         [0007]    Other aspects of the present invention will be in part apparent and in part pointed out hereinafter. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a fragmented side elevation of a surgical instrument of the present invention; 
           [0009]      FIG. 2  is a perspective of an end effector of the surgical instrument shown with a fastener while in a closed position; 
           [0010]      FIG. 3  is a the perspective of the end effector shown with a fastener while in an open position; 
           [0011]      FIG. 4  is a perspective of the end effector shown without the fastener while in the closed position; 
           [0012]      FIG. 5  is a perspective of the end effector shown without the fastener while in the open position; 
           [0013]      FIG. 6  is a perspective of the end effector shown without a portion of a housing while in the open position; 
           [0014]      FIG. 7  is a perspective of the end effector shown without the portion of the housing while in the closed position; 
           [0015]      FIG. 8  is a perspective of the end effector shown without the portion of the housing while in a fully collapsed position; 
           [0016]      FIG. 9  is a section of a grip of the instrument; and 
           [0017]      FIG. 10  is a schematic cross section of a male jaw of an alternate embodiment of the present invention. 
       
    
    
       [0018]    Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0019]    Referring now to the drawings and in particular  FIG. 1 , a surgical instrument of the present invention is generally designated by the reference number  20 . The instrument is specifically adapted for performing endoscopic surgery to fold and fasten tissue. The instrument  20  generally includes an end effector (generally designated by  22 ) and a handle assembly (generally designated by  24 ) mounted on opposite ends of an elongate shaft  26 . The shaft  26  has a working end  28 , on which the end effector  22  is mounted, and a grip end  30 , on which the handle assembly  24  is mounted. 
         [0020]    In one embodiment, the shaft  26  is a flexible hollow tube having a circular cross section, a length of between about fifty centimeters (cm) and about 150 cm, and an outside diameter of between about two millimeters (mm) and about five mm. Although the shaft  26  may be made of other materials without departing from the scope of the present invention, in one embodiment the shaft is made of coiled stainless steel wire. In an alternative embodiment, it is envisioned that the shaft  26  may be rigid. 
         [0021]    The end effector  22  is adapted apply a two-part fastener  40  to tissue to hold it in position. Although the end effector  22  may be adapted to apply other types of fasteners without departing from the scope of the present invention, in one embodiment the end effector is adapted for use with a two-part fastener, generally designated by  40 , such as described in U.S. Pat. No. 7,033,378. As shown in  FIGS. 2 and 3 , the fastener  40  includes a male component, generally designated by  42 , and a female component, generally designated by  44 . The male component  42  includes a base  46  and needles or protrusions  48  extending outward from the base. The female component  44  includes a base  50  and openings or recesses  52  for receiving the needles  48  of the male component  42 . As the use and construction of two-part fasteners  40  such as disclosed in U.S. Pat. No. 7,033,378 are well known by those skilled in the art, they will not be described in further detail. The female component  44  includes a lock  54  for locking the female component on the male component  42  when the protrusions are positioned in the recesses  52 . 
         [0022]    As shown in  FIG. 2 , the end effector  22  includes a housing, generally designated by  60 , mounted on the working end  28  of the shaft  26 . The end effector  22  includes a first jaw or male jaw, generally designated by  62 , pivotally mounted on the housing  60  with a pin  64 . The male jaw  68  includes a generally rectangular receptacle or receiver  66  ( FIG. 4 ) adapted for receiving a base  46  of a male component  42  as illustrated. The end effector  22  also includes a first jaw or female jaw, generally designated by  68 , statically mounted on the housing  60 . The female jaw  68  extends generally parallel to the shaft toward the grip end  30  of the shaft  26 . The female jaw  68  includes a generally rectangular receptacle or receiver  70  ( FIG. 4 ) adapted for receiving a base  50  of a female component  44  as illustrated in  FIG. 2 . The receptacle  64  of the male jaw  68  receives the base  46  of the male component  42  as illustrated so the needles  48  of the male component generally face the openings  52  in the female component  44 . The instrument  20  may be actuated as explained below so the male jaw  68  pivots about the pin  64  between an open position as shown in  FIG. 3  for receiving tissue between the male and female jaws to a closed position as shown in  FIG. 2  for joining the male component  42  of the fastener  40  with the female component  44  of the fastener thereby applying the fastener to the tissue of the patient. 
         [0023]    A sleeve  72  is provided on the housing  60  for receiving a tip of an endoscope (not shown) so the physician can view the tissue as the fastener is applied. The sleeve  72  includes an opening  74  having a diameter corresponding to a small endoscope (e.g., about twelve mm). The sleeve  72  may be mounted on the housing  60  with screw fasteners  76  as shown in  FIG. 5  so the sleeve can be removed when not in use to reduce the overall effective cross-sectional area of the instrument  20 . Although the sleeve  72  may be made of other materials without departing from the scope of the present invention, in one embodiment the sleeve is made of a soft, low friction, lubricious material such as polytetrafluoroethylene (PTFE), nylon, or silicone to facilitate the endoscope entering the opening  72 . 
         [0024]    As illustrated in  FIGS. 4 and 5 , the receptacle  70  of the female jaw  68  includes a large rectangular opening  80  that is sized to receive the base  50  of the female component  44  of the fastener  40 . The receptacle  64  has a ledge  82  at one end, and a lug  84  extending into the opening  80  from each side. The female component  44  of the fastener  40  is inserted into the opening  80  in a locked position (as shown in  FIG. 2 ) so a locking feature  86  is spaced from a head  88  of the female component. The base  50  of the component  44  is overlapped with the ledge  82  and the locking feature  86  and head  88  are positioned on opposite sides of the lugs  84 . Once the female component  44  is in position, the locking feature  86  of the component is moved toward the head  88  so the female component is in an unlocked position (as shown in  FIG. 3 ). When the female component  44  is in the unlocked position, the head  86  overlaps the ledge  82  and the locking feature  86  captures the lugs  84  so the female component  44  is held firmly in the receptacle  70  of the female jaw  68 . As shown in  FIG. 5 , a torsion spring  90  is provided on the female jaw  62  for forcing the female component  44  of the fastener toward the end of the jaw. The torsion spring  90  aligns the female component  44  with the male component  42  as the male jaw  68  is rotated toward the female jaw  68 . Further, the female jaw  68  includes a push rod  92  for pushing the female component  46  so it does not overlap the ledge  82  to release the female component from the receptacle  72  as described below. 
         [0025]    The male jaw  68  includes a rectangular recess  66  adapted to receive the base  46  of the male component  42  of the fastener  40 . The recess  66  includes two counterbored holes  94  and two threaded holes  96 . When the male component  42  is loaded into the recess  66  of the male jaw  68 , the stub ends  98  of the protrusions  48  are received in the counterbored holes  94  to hold the protrusions in an upright configuration and prevent them from rotating into a collapsed configuration. As shown in  FIG. 2 , the outside of the male jaw  62  also includes a recess  100 . A releasable catch  102  is positioned in the recess  100  for engaging holes  104  provided in each of the stub ends  98  of the protrusions  48  of the male component  42  to hold the component in the receptacle  66 . A cantilevered cover  106  is positioned above each threaded hole  96  and held in place with a screw fastener  108 . The covers  106  reduce a potential for inadvertently releasing the catch  102  from holes  104  in the stub ends  98  of the protrusions  48  of the male component  42 . 
         [0026]    Referring to  FIG. 5 , the housing  60  includes a mount  110  to which the shaft  26  ( FIG. 1 ) is attached. Although the mount  110  may be integrally formed with the housing  60 , in one embodiment the mount is pivotally attached to the housing with a pin  112  to permit the end effector  22  angle to be adjusted relative to the shaft  26 . 
         [0027]    As shown in  FIG. 6 , a first bell crank  120  is rotatably mounted in the housing  60  for rotation about a screw fastener  122  ( FIG. 2 ). A control cable  124  is connected to one side of the bell crank  120  and a wire linkage  126  is connected to the other side of the bell crank. The linkage  126  is wrapped around a hub  130  of the male jaw  62 . When the control cable  124  is pushed, the bell crank  120  rotates to push the wire linkage  126  and rotate the male jaw  62  to the open position shown in  FIG. 6 . Pulling the control cable  124 , rotates the bell crank  120  to pull the wire linkage  126  and rotate the male jaw  62  to the closed position shown in  FIG. 7 . Referring to  FIG. 6 , when the male jaw  62  is in the fully open position tissue may be positioned between the male and female jaw. As the male jaw  62  is closed, the relative position between the tissue and the female jaw  68  does not change. Thus, the configuration described above in which only the male jaw  62  rotates facilitates proper positioning of the fastener  40 . Once the fastener  40  is applied and withdrawn from the receptacles of the male and female jaws,  62 ,  68 , respectively, the control cable  124  may be pulled to rotate the bell crank  120  farther to pull the wire linkage  126  and close the jaws more as shown in  FIG. 8  to facilitate withdrawal of the instrument  20  from the patient. 
         [0028]    Referring to  FIGS. 6-8 , a second bell crank  140  is also rotatably mounted in the housing  60  for rotation about another screw fastener  142  ( FIG. 2 ). A control cable  144  is connected to one side of the bell crank  140 . A finger  146  extends from the other side of the bell crank  140 . The finger  146  is aligned with the push rod release element  92  and the catch  102  ( FIG. 6 ) when the male jaw  62  is in the closed position ( FIG. 7 ). When the male jaw  62  is in the closed position as shown in  FIG. 6  and the control cable  144  is pushed, the second bell crank  140  turns forcing the finger  146  against the release element  92 . As the release element  92  in the female jaw  68  moves outward in the jaw, the element engages the female component  46  to lock it on the male component  42  and to release it from the receptacle  70  of the jaw. Simultaneously, the finger  146  is forced against the catch  102  to release the stub ends  98  of the protrusions  48  from their respective counterbored holes  94 , thereby releasing the male component  42  from the recess  66  of the male jaw  62 . As will be appreciated by those skilled in the art, other control means may be substituted for the bell cranks  120 ,  140  and corresponding cables without departing from the scope of the present invention. As numerous alternative embodiments of the control means are well within the abilities of the ordinary artisan, they will not be described in any detail. 
         [0029]    The handle assembly  24  operates the control the male jaw  62  to open and close the end effector  22  and to lock and release the fastener  40  from the surgical instrument  20  as described in detail below. As illustrated in  FIG. 9 , the handle assembly  24  includes a stationary pistol grip  150  and a lever  152  pivotally attached to the grip when a pin  154 . The grip  150  is integrally firmed with a housing  156  having a slot  158  forming in one side. The control cable  144  connected the second bell crank  140  controlling the push rod  92  and releasable catch  102  for locking the fastener  40  and ejecting it from the end effector  24  is attached to a sliding knob  160  captured in the slot  158 . The control cable  124  extends from an end of the shaft  26 , around a pulley  170  mounted in the housing and connects to the lever  152  so the control cable is pulled as the lever is moved toward the pistol grip  150  to move the male jaw  62  toward the closed position. The lever  152  is biased away from the grip  150  by a first spring  172  extending between the lever and a mount  174  on the housing  156 . The lever  152  also includes a lock, generally designated by  180 , for locking it in position relative to the grip  150 . The lock  180  includes a pawl  182  biased against teeth  184  on the lever  152  by a spring  186  extending between the pawl and a mount  188  on the housing  156 . A cam  190  mounted on the housing adjacent the pawl  182  is connected to a knob  192  ( FIG. 1 ) that may be turned to disengage the pawl from the teeth  184  to allow the lever to return to its most forward position. 
         [0030]    In operation, when the handle assembly lever  162  is pivoted toward to the stationary grip  150 , the male jaw  62  closes. With the male jaw  62  in the closed position, the cross bar knob  160  is moved forward relative to the housing  156  to lock and release of the fastener  40 . After a fastener  40  is released, the cam knob  192  is turned to release the lever lock  180  permit the lever  152  to return to its initial position and allow the male jaw  62  to open. 
         [0031]    Although the handle assembly  24  may be made of other materials without departing from the scope of the present invention, in one embodiment the handle assembly is molded from polycarbonate. Although the end effector  22  may be made of other materials without departing from the scope of the present invention, in one embodiment the end effector is made from stainless steel. 
         [0032]    To use the instrument  20  described above, a male component  42  of a fastener  40  is loaded in the receiver  66  of the first jaw  62  so the stub ends  98  of the protrusions  48  extend through the counterbored holes  94 . The knob  160  is moved in the slot  158  so the catch  102  engages the holes  104  in the stub ends  98  of the protrusions  48  to hold the male component  42  in the receiver  66  of the first jaw. A female component  44  of the fastener  40  is loaded into the receiver  40  of the second jaw  68 . The female component  44  is unlocked so its lock  54  overlaps the ledge  82  of the second jaw  68  and the lugs  84  are captured between the locking feature  86  and the head  88  to retain the female component in the receiver  40  of the second jaw. 
         [0033]    Once the male and female components  42 ,  44 , respectively, are loaded in the first and second jaws  62 ,  68 , respectively, the handle assembly  150  is manipulated to position female jaw adjacent the tissue to be fastened. A conventional tissue retractor (not shown) may be used to position the tissue adjacent the female component  44  held in the female jaw  68 . Once the tissue is in position relative to the second jaw  68 , the lever  152  is pulled toward the handle  150  to pivot the male jaw  62  toward the tissue and the female jaw. As the male jaw  62  pivots, the protrusions  48  of the male component  42  pierce the tissue and enter the openings  52  in the female component  44 . While the male jaw  62  is in this closed position, the knob  160  is moved to disengage the catch  102  from the openings  104  in the stub ends  98  of the protrusions  48  to release the male component  62 . Simultaneously, the release  92  extends into the opening  80  of the female jaw  68 , activating the lock  54  of the female component  44  so the protrusions  48  are locked in the openings  52 . Further, the release  92  disengages the lock  54  from the ledge and spaces the locking feature  86  from the head  88  so the lugs  84  are released, thereby releasing the female component  44  from the female jaw  68 . Once the male and female components  42 ,  44 , respectively, are released from the respective jaws, the knob  192  can be turned to release the lever lock  180 , allowing the lever  152  to be moved away from the grip  150 . As the lever  152  is moved away from the grip  150 , the jaws are spaced to completely disengage the fastener  40 . The lever  152  may again be moved toward the grip  150  to totally collapse the jaws against each other as shown in  FIG. 4 , reducing the end effector  22  profile for withdrawing the end effector from the patient. Once removed, the end effector  22  can be reloaded and the procedure may be repeated. 
         [0034]    Many conventional fastener systems have jaws that move relative to the handle assembly  24 , making it difficult to precisely position the fastener  40  on the tissue. The instrument  20  of the present invention overcomes this problem by allowing only one jaw to move and keeping the other jaw stationary relative to the handle assembly  24 . 
         [0035]      FIG. 10  illustrates a male jaw  200  of another embodiment of a surgical instrument of the present invention. The male jaw  200  includes internal channels  202 , each of which end in an opening  204  at a face  206  of the jaw. One elongate needle  210  is slidably received in each channel  202 . Each of the needles  210  includes a pointed tip  212  at a leading end of the needle for reducing trauma to tissue T as the end of the needle enters the tissue. Further, each needle  210  includes a head  214  on an end opposite the pointed tip  212 . Although the needles  210  may have other dimensions without departing from the scope of the present invention, in one embodiment each of the needles has a length of between about eight mm and about fifteen mm, and a width of between about one mm and about 1.5 mm. Although the needles  210  may be made of other materials without departing from the scope of the present invention, in one embodiment the needles are made of Nitinol and have shape memory so that once they are ejected from the channel  202 , they return to a straight shape. An ejector rod  220  is positioned in each channel  202  behind the head  214  of the needle  210 . A conventional mechanism (e.g., a bell crank) may be used to advance the ejector rods  220  to eject the needles from the openings  204  in the face  206  of the jaw  200 . The male jaw  200  also includes a receiver  230  for receiving a male fastener plate  232  having holes  234  through which the needles  210  are driven. The needles continue through the tissue and into corresponding openings in the base of a female component as described above. As will be appreciated by those skilled in the art, this embodiment permits the fasteners to be positioned very precisely, because the female component of the fastener and the male fastener plate  232  can be precisely positioned before the needles  210  are advanced through the tissue. As will be further appreciated by those skilled in the art, the needles  210  may be ejected from the stationary jaw (making it the male jaw) without departing it from the scope of the present invention. Because the other features of the instrument of the second embodiment may be identical to those of the first embodiment described above, they will not be described in further detail. 
         [0036]    When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. 
         [0037]    As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.