Abstract:
An endoscopic staple and related stapling device that can be used in conjunction with flexible or rigid endoscopy. The staple can also be used for other surgical procedures. The invention relates to performing a stapling operation on internal body tissues as part of a surgical procedure, diagnostic procedure or therapeutic procedure. This invention includes a surgical staple, an associated staple holder, and an associated staple delivery and deployment device. The staple holder and delivery system have a design iteration whereby the holder can be reloaded with additional staples to be used on the same patient. There is another design iteration whereby the staple holder and stapler are reusable after appropriate cleaning and sterilization.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to endoscopy and, more particularly, to a staple and a device used to secure or staple tissue inside the human body with said staple and device working in conjunction with a flexible endoscope.  
       BACKGROUND OF THE INVENTION  
       [0002]     Surgeons have developed a number of methods and techniques to treat a variety of medical anomalies in the abdomen and gastrointestinal tract. These procedures often involve stapling and must be performed during open surgery or rigid laparoscopic surgery because there is no device or reliable method for placing staples using flexible endoscopes. Suturing has the same current limitations and as such the medical community is unable to perform surgical procedures via natural body openings using flexible endoscopes. Surgical procedures for removing diseased organs, gastric bypass surgery performed in morbidly obese patients, and a variety of other surgical procedures must be performed during open or laparoscopic surgery.  
         [0003]     Providing the physicians with a flexible stapling device to be used in conjunction with a flexible endoscope would significantly reduce the length and complexity of the surgery. Consequently, morbidity and mortality would be reduced; hospital stay shortened, and cost savings provided. Because flexible endoscopic procedures are typically performed under conscious sedation and are much less invasive, they are naturally less traumatic to the body. Convalescence is significantly shortened, postoperative pain is virtually eliminated and patients are ambulatory within hours after an endoscopic procedure.  
         [0004]     The only means of treating a problem that requires surgery in the abdomen is through open or laparoscopic surgery. Bypass and gastric restrictive surgery for the morbidly obese patient is being performed during open or laparoscopic surgery. These operations take five to seven hours and are performed under general anesthesia. The recovery typically takes six weeks to three months if the operation is successful. Recently, a new procedure has been introduced during which a band is placed around the stomach. This operation is less complex than the abovementioned procedures but is also being performed through open or laparoscopic means.  
         [0005]     These complex and invasive surgical procedures require general anesthesia, surgical incisions, multiple days in the hospital, and significant use of medication for postoperative pain and lengthy periods of convalescence. Surgical procedures to treat morbidly obese patients have a high incidence of complications and thus limit the number of patients that can benefit from these procedures. These operations are currently performed through a large abdominal incision. The physician excludes or closes off a large portion of the stomach. In addition, a portion of the small intestine is bypassed, and a new connection to the stomach is made. Oftentimes the patient has had prior surgery causing adhesions, which bind the intestines together. The surgeon has to dissect these adhesions and free the bowel in order to get to the operative site. This procedure is quite difficult, and has to be performed before the actual bypass and gastric stapling operation has even begun. This surgery can also be performed laparoscopically. However, while the incisions are smaller, the abdomen is filled with a large amount of gas in order to distend it and enable the surgeon to perform the operation. The surgery is more difficult and typically takes two to three hours longer than the open operation. This requires longer anesthesia time increasing the danger to the patient. The distended abdomen impinges on the patient&#39;s lungs decreasing breathing capacity and adding morbidity. While this is a less invasive procedure than open surgery, it still entails significant complications and lengthy patient convalescence. Furthermore, because the surgery takes longer than open surgery, risk to the patient is increased from prolonged general anesthesia. The less traumatic banding procedure is less complicated, however reports of band slippage and postoperative infection exist. In addition, results have been poor.  
       OBJECTS OF THE INVENTION  
       [0006]     It is an object of this invention to provide a medical instrument for closing openings internal to a patients body utilizing flexible or rigid endoscopes inserted into the body primarily, though not exclusively, through existing body orifices.  
         [0007]     It is another object of the invention to provide a surgical procedure for closing openings internal to a patient&#39;s body, which is quicker, safer and less invasive than the conventional surgical procedures, thereby, significantly reducing patient morbidity and mortality.  
         [0008]     It is a further object of this invention to provide a means to entirely eliminate external scars from surgery because the entire operation is to be performed inside the body and through an existing orifice.  
         [0009]     It is another object of this invention to reduce anesthesia time, strength of anesthetics used, post operative pain, hospital stay and convalescence time, particularly with respect to operations closing openings internal to a patients body.  
         [0010]     It is a further object of this invention to provide a staple used to close or clamp tissue within the body that can be passed through a flexible endoscope.  
         [0011]     It is another object of this invention to provide a staple delivery instrument that can be used in conjunction with flexible and rigid endoscopes with a working channel diameter no larger than 3.8 millimeters.  
         [0012]     It is yet another object of this invention to provide a long, flexible staple delivery device that can be passed deep into the organ to be operated upon.  
         [0013]     It is also an object of this invention to provide a special staple that will enter into the organ deeply enough to hold the desired tissues together, and with a closure strong enough to keep these tissues securely affixed to one another.  
         [0014]     These and other objects of the invention will be apparent from the drawings and descriptions herein. Every object of the invention is believed to be attained by at least one embodiment of the invention. However, there is not necessarily any single embodiment that achieves all of the objects of the invention.  
       SUMMARY OF THE INVENTION  
       [0015]     In accordance with the present invention, there is provided an endoscopic staple and related stapling device that can be used in conjunction with flexible or rigid endoscopy. The staple can also be used during other surgical procedures. The invention relates to performing a stapling operation on internal body tissue as part of a surgical procedure, diagnostic procedure or therapeutic procedure. This invention includes a surgical staple, an associated staple holder, and an associated staple delivery and deployment device. The staple holder and delivery system have a design iteration whereby the holder can be reloaded with additional staples to be used on the same patient. There is another design iteration whereby the staple holder and stapler are reusable after appropriate cleaning and sterilization.  
         [0016]     An endoscopic stapling assembly for securing tissue internal to the body, utilizing a flexible endoscope, comprises, in accordance with the present invention, a staple for clamping or securing tissue inside of the body and a locking element operatively engageable with the staple for securing the staple in a closed position once staple is positioned and closed on desired tissue. The stapling assembly additionally comprises a tubular member providing a working channel for active stapler components, and a stapler holder connected to the tubular member for holding the staple during deployment thereof and manipulating the staple into an open or closed position. The active stapler components are operatively connected to the staple holder for operating the same. The assembly further comprises means such as a tray for holding additional staples to facilitate loading of the additional staples into the staple holder.  
         [0017]     The staple, preferably made of a shape memory or flexible material is insertable into tissue for clamping together opposing segments of tissue. Preferably, the staple is biased to an open position having an open-position angle greater than an open-position angle of the staple holder.  
         [0018]     Pursuant to a further feature of the present invention, the staple is provided with notches along a backside of the staple to guide, accept, and secure a locking element in the form of a backbone or brace. The backbone is made of rigid material having a pair of legs or prongs slidable over a backside of the staple and securable firmly over the closed staple. The backbone legs have inwardly extending protrusions engageable in the notches or recesses provided in the staple for locking into place over the closed staple. The jaws of the staple holder are re-loadable with additional staples and backbone locking elements from the staple-holding tray.  
         [0019]     The staple is preferably configured with opposing legs of a single folded-over material, the legs being formed in an arc configuration and having pointed distal tips that touch one another when the staple is in a closed position.  
         [0020]     To secure the staple in a closed position, an actuator in the form of a push bar is provided for advancing the backbone over the staple, the push bar being connected to a handle mechanism at a proximal end of the tube providing the working channel.  
         [0021]     The staple holder may specifically comprise formed metal components connected to a drive-wire and handle mechanism. The formed metal components may be comprised of opposing jaws, whereby opposing edges or inner surfaces of the jaws are formed to securely hold the staple, and wherein the jaws are adapted to enter and grasp tissue.  
         [0022]     Pursuant to an additional feature of the present invention, the distal ends of the jaws are pointed for enabling the jaws to enter targeted tissue. The staple holder includes means for operating the jaws to clamp the staple closed over the tissue, the jaws being provided along mutually facing surfaces with grooves for seating the staple and allowing for the backbone to slide over the closed staple.  
         [0023]     The staple-holding tray is provided with preformed holes to securely hold staples in an open configuration and is also provided with orientation structure for maintaining a plurality of backbones at proximal ends of the staples in the tray. The backbones are engageable with the respective staples to maintain the staples in a closed post-firing configuration.  
         [0024]     A staple assembly for use in rigid or flexible endoscopy for securing tissue internal to the body comprises, in accordance with the present invention, means for clamping or securing tissue inside of the body, and means, engageable with the means for clamping or securing, for locking the staple in a closed position once the staple is positioned and closed on desired tissue.  
         [0025]     In a preferred embodiment of the invention, the means for clamping or securing tissue inside of the body comprises a staple capable of being opened and closed. The staple is biased to an open position and has an open position angle that is is greater then an open position angle of a staple holder component. The staple may include opposing legs of a single folded-over member, the legs being formed in an arc configuration and having pointed distal tips that touch when the legs are in a closed position. In addition, the means for locking includes a backbone element, the staple having notches along a back of the staple to guide, accept, and secure the backbone to the staple.  
         [0026]     An endoscopic staple and stapler assembly for securing tissue internal to the body comprises, in accordance with a specific embodiment of the present invention, a staple holder component and a staple capable of being opened and closed. The staple is releasably held by the staple holder component and is biased to an open position. The staple has a biased open position angle that is greater then an open position angle of the staple holder component. The staple is made from shape memory or flexible metal and has opposing legs of a single folded-over member, the legs being formed in an arc configuration. The staple legs have pointed distal tips that touch when the staple is in a closed position, the distal tips of the legs being pointed for the purpose of clamping or entering tissue for securing tissue inside of the body. The endoscopic staple and stapler assembly further includes a backbone made of rigid material that is slidable over a backside of the staple. The staple has notches or recesses along a backside to guide, accept, and secure the backbone firmly over the staple in a closed position once the staple is positioned and closed on desired tissue. A push bar is included in the endoscopic staple and stapler assembly for advancing the backbone over the staple, the push bar being temporarily effectively coupled to the backbone. The staple holder component includes a pair of opposing jaws formed to securely hold the staple, adapted to enter and grasp tissue, and attached to a drive mechanism that opens and closes the jaws. The jaws hold the staple securely, grasp targeted tissue, and clamp the staple closed over the tissue while the backbone is slid over the closed staple. An elongate tube has a distal end connected to the jaw mechanism and a proximal end connected to an actuation and handle mechanism. The tube has at least one lumen and is made of a flexible material, for providing a working channel for active stapler components, securely connected to the staple holder. A handle mechanism provided for actuation and manipulation is securely connected to the elongate tube and operatively connected to the push bar.  
         [0027]     The present invention is directed in part to a tray provided with a plurality of first preformed holes adapted to securely hold staples in an open configuration. The tray also includes a plurality of second preformed holes aligned with respective ones of the first preformed holes for maintaining staple-locking backbones disposed in a prelocking position on proximal ends of respective ones of the staples, the tray serving to facilitate loading of the staples and backbones into a staple-holding jaw mechanism of a stapling device. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0028]     A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which:  
         [0029]      FIG. 1  is a schematic perspective view, of a cross-section of an endoscopic stapling device in accordance with the present invention, showing a staple, a backbone, and a staple holder mechanism, in an open position.  
         [0030]      FIG. 2  is a schematic perspective view, similar to  FIG. 1 , showing the endoscopic stapling device of that drawing figure in a closed position.  
         [0031]      FIG. 3  is an exploded schematic perspective view showing the staple and the backbone of  FIGS. 1 and 2 .  
         [0032]      FIG. 4  is a schematic perspective view similar to  FIG. 3 , showing the staple in an open position with the backbone in a proximal position.  
         [0033]      FIG. 5  is a schematic perspective view showing the staple of  FIGS. 3 and 4  in a closed position with the backbone disposed over the staple, locking the staple in the closed position.  
         [0034]      FIG. 6  is a schematic perspective view showing the staple and stapler device of  FIGS. 1 and 2  approaching tissue to be secured  
         [0035]      FIG. 7  is a schematic perspective view showing the staple and stapler device inserted into tissue to be secured  
         [0036]      FIG. 8  is a schematic perspective view showing the staple and stapler in closed position securing tissue  
         [0037]      FIG. 9  is a schematic perspective view showing the staple and backbone deployed into tissue and released from stapler.  
         [0038]      FIGS. 10A-10E  are partially schematic side elevational views of a proximal end and partially schematic cross-sectional views of a distal end of an endoscopic stapling device in accordance with the present invention, showing successive steps in the utilization of the device.  
         [0039]      FIG. 11  is a schematic perspective view showing a staple tray assembly in accordance with the present invention. 
     
    
       [0040]     For purposes of clarity and brevity, like elements and components will bear the same designations and numbering throughout the FIGURES.  
       DEFINITIONS  
       [0041]     The term “endoscopic” is used herein to designate any of a variety of minimally invasive surgical procedures wherein optical elements are used to view internal spaces and tissues of the patient through relatively small, natural or surgically created openings in a patient. Concomitantly, the term “endoscope” as used herein refers to any optical instrument inserted through such a small opening for purposes of enabling visualization of internal tissues during a minimally invasive procedure.  
         [0042]     An endoscopic stapling device as described herein is inserted through a working channel of an endoscopic instrument. An “endoscopic instrument” may include optical illumination and image transmission components or may be a simple tube, such as a cannula. More generally, an endoscopic instrument may be any instrument that is used to perform an endoscopic diagnostic or surgical procedure.  
         [0043]     The term “open position angle” refers herein to the most open configuration of a staple or a pair of jaws. Two relatively inclined elements (legs, prongs, jaws) subtending a larger open position angle than another two relatively inclined elements means that the first two elements naturally open to a wider extent than the second two elements.  
         [0044]     The term “backbone” as used herein denotes a locking element that is engageable with a staple or clip to hold the staple or clip in a closed configuration in the tissues of a patient. The term “backbone” is more particularly meant to designate a locking element that fits along the back or outside of a spring-biased staple to provide rigidity and stability to the staple in a closed configuration. Preferably, a staple used with a backbone as described herein is spring biased by internal stresses of its memory or shape alloy material to an open configuration. The backbone counteracts that spring bias to hold the staple closed upon deployment in organic tissues. In a specific embodiment disclosed herein, a staple backbone comprises a pair of legs pr prongs projecting in parallel to one another, the legs or prongs being provided with inwardly extending protrusions for mating with similarly shaped notches or recesses in respective staple legs to secure the backbone to the staple. The staple in addition or alternatively may be provided along outer surfaces of its own legs or prongs with grooves that receive the legs or prongs of the backbone in a seating relationship.  
         [0045]     The term “active stapler components” refers herein generally to movable components of an endoscopic stapling device, which move during use of the device to effect various steps in an endoscopic stapling procedure. Those steps include, but are not necessarily limited to, ejection of a staple holder, the opening and closing of staple holder jaws, the insertion of a staple holder and an entrained staple into internal organic tissues of a patient, the movement of a backbone over a staple, the removal of staple jaws from a deployed and locked staple.  
       DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0046]      FIG. 1  is a perspective view, partly in cross section , of a distal end of an endoscopic stapling device or assembly  8  for use in inserting a staple  10  deeply into internal organic tissues of a patient. Staple  10  includes a pair of legs or prongs  10   a  and  10   b  each provided with a staple notch, aperture, or recess  13  for enabling a locking of the staple in a closed post-firing configuration. Staple  10  is locked in the closed configuration by a backbone  12  (see  FIGS. 2-5 ) comprising a pair of legs or prongs  12   a  and  12   b  projecting parallel to one another from a body portion  12   c . Body portion  12   c  has opposing planar faces  12   d  and is provided at a rear or proximal end with a cutout  12   e  serving as a seat for the distal end of a push bar  22 . As discussed below, backbone  12  is disposed back behind the staple  10  until the staple is inserted into the tissues and is ready to be locked.  
         [0047]     In addition to staple  10 , backbone  12  and pushbar  22 , endoscopic stapling assembly  8  includes a staple holder  16 , an elongate tube  14 , and one or more drive wires or rods  26 . Staple  10  initially sits within the jaws  16   a  and  16   b  of the staple holder  16  with the backbone  12  positioned at a proximal end of the staple  10  and contained within the staple holder  16  and elongate tube  14 .  
         [0048]     Jaws  16   a  and  16   b  of staple holder  16  are formed along inner surfaces (not labeled) with respective longitudinally extending grooves or recesses  16 c and  16 d for removably receiving legs  10   a  and  10   b  of staple  10 . Grooves  16   c  and  16   d  may be approximately the same size and shape as staple legs  10   a  and  10   b , for seating the staple so as to prevent a forward or lateral displacement of the staple from the staple holder  16  prior to completion of a staple closing operation.  
         [0049]     Staple  10  is biased to an open position angle greater than the open position angle of staple holder  16 , thus exerting outward pressure on staple holder  16  and serving to maintain staple  10  within staple holder  16  in an open configuration of the staple and the staple holder. This force contributes to staple retention and maintaining staple  10  in position inside the staple holder  16  when staple  10  and staple holder  16  are inserted into the targeted tissue to be secured. Backbone  12  contributes to staple  10  maintaining the preferred position inside staple holder  16  jaws by providing resistance against staple  10  and keeping staple  10  from sliding proximally as these components are inserted into tissue. Staple holder  16  is connected to elongate tube  14  and an actuation assembly, which includes drive wires or rods  26  that activate the jaws  16   a  and  16   b  of the staple holder  16 . Elongate tube  14  contains push bar  22  which slides distally to push backbone  12  over staple  10  after the staple and the holder  16  have been inserted into tissues, as discussed below with reference to  FIGS. 6-9 . Push bar  22  is operatively connected to a component of a handle mechanism  24  ( FIGS. 10A-10E ) which controls the forward motion of the push bar  22 .  
         [0050]      FIG. 2  is a cross sectional view of the distal end of endoscopic stapling assembly  8 , showing staple  10  with staple notches  13   a  and  13   b  in legs  10   a  and  10   b , backbone  12  with two protrusions  15   a  and  15   b  extending inwardly from respective legs or prongs  12   a  and  12   b , staple holder  16 , elongate tube  14 , drive wires  26 , and push bar  22 , with staple  10  and holder  16  disposed in a closed position. After the insertion of holder  16  and staple  10  into target tissues inside a patient, backbone  12  is slid forward over the closed staple  10  and locked into position by means of staple notches  13   a  and  13   b  and backbone protrusions  15   a  and  15   b . Staple holder  16  is made from a rigid metal with opposing jaws that meet and align when closed. The closing of staple holder  16  jaws results in the closing of staple  10  and alignment of staple legs  10   a  and  10   b.    
         [0051]      FIG. 3  is a perspective view of staple  10  which is composed of a flexible metal that allows for repeat opening and closing of staple  10 . Legs  10   a  and  10   b  of staple  10  are joined at the proximal end or formed by bending or folding a single metal component at a center point. Staple legs  10   a  and  10   b  have preformed channels  11   a  and  11   b  on the outside surfaces of the legs. Notches  13   a  and  13   b  communicate with the respective channels or grooves  11   a  and  11   b . Channels  11   a  and  11   b  serve to guide legs  12   a  and  12   b  of backbone  12  over legs  10  and  10   b  of staple  10  during a distally directed staple-closing stroke of push bar  22 , while notches  13   a  and  13   b  serve to guide and secure the backbone  12  and, more specifically, backbone protrusions  15   a  and  15   b  when backbone  12  is slid over the closed staple  10  in the target organic tissues. Backbone  12  is composed of rigid metal whose structural force is greater than the open angle force of staple  10 . Channels  11   a  and  11   b  may be opposite end portions of a single channel or groove in the backside or outwardly facing surface (not separately labeled) of staple  10 .  
         [0052]      FIG. 4  is a perspective view of staple  10  and backbone  12  in proximal position to staple  10 . The configuration of  FIG. 4  occurs when staple holder  16  and staple  10  are partially opened after insertion of the distal end portion of assembly  8  into a patient during an endoscopic or laparoscopic surgical procedure.  
         [0053]      FIG. 5  is a perspective view of the backbone  12  with legs or prongs  12   a  and  12   b  disposed in the staple closed position over respective legs  10   a  and  10   b  of staple  10 . Backbone  12  is slid from the proximal end of staple  10  toward the distal end of staple  10  along the preformed channels  11   a  and  11   b  in the outer walls of staple  10 . Backbone protrusions  15   a  and  15   b  have diameters that match the diameters of channels  11   a  and  11   b  and of notches  13   a  and  13   b  formed in the outside surfaces or faces of staple  10 . Backbone protrusions  15   a  and  15   b  lock into the respective notches  13   a  and  13   b  when backbone  12  is fully pushed down channels  11   a  and  11   b  of staple  10  in the closed position. Backbone  12  locks in place, maintaining staple  10  in a fully closed position over the captured tissue.  
         [0054]      FIG. 6  is a perspective view of the distal end of endoscopic stapling device or assembly  8  as the device is passed through a working channel  30  of an endoscope  32  and approaches target tissue TS. Staple holder  16  is opened by manipulation of handle  24  ( FIGS. 10A-10E ) after the holder emerges from the distal end of the endoscope  32 . In the opened configuration of holder  16  shown in  FIG. 7 , the staple  10  and the backbone  12  have the configurations and relative positions shown in  FIG. 4 .  
         [0055]     It is to be noted that staple holder  16  has a pointed distal end for penetrating the targeted tissue. More particularly, holder jaws  16   a  and  16   b  have pointed tips  16 e and  16 f that enable a deep penetration of jaws  16   a ,  16   b  and concomitantly staple  10  into the target tissue TS.  
         [0056]      FIG. 7  is a perspective view of the distal end of endoscopic stapling device  8  as the jaws  16   a  and  16   b , together with staple  10 , penetrate the targeted tissue TS. When the tissue TS is located by the endoscopist, staple holder  16 , in the open position, is pushed into the tissue. Staple  10  and backbone  12  still have the configurations and relative positions of  FIG. 4 .  
         [0057]      FIG. 8  is a perspective view of the distal end of the endoscopic stapling device  8  as the staple holder  16  is closed over the captured tissue TS. The closure of holder  16  causes staple  10  to close as well. Staple holder  16  is closed by manipulation of the device handle  24 , capturing the targeted tissue TS. More specifically, this closure may be effectuated, for instance, by drawing wires or rods  26  in a proximal direction. Handle  24  is then manipulated in a second movement, which shifts the push bar  22  in the distal direction and consequently advances the backbone  12  over the closed staple  10  that is inside the staple holder  16 . Backbone  12  locks in place on the closed staple  10 , as discussed above with references to  FIGS. 2 and 5 , and secures the captured tissue TS. Staple holder  16  is then opened by a reverse manipulation of the handle  24  and removed from the tissue. Staple  10  and backbone  12  remain on the captured tissue.  
         [0058]      FIG. 9  is a perspective view of the distal end of the endoscopic stapling device  8  after deployment of staple  10  and backbone  12 . Staple holder  16  is closed by manipulation of handle  24  and pulled back through the endoscope working channel  30 .  
         [0059]      FIGS. 10A-10E  are partially schematic elevational views of the handle mechanism  24  at a proximal end of an endoscopic stapling device  34 .  FIGS. 10A-10E  are also partially schematic cross-sectional views of a stapling mechanism  36  at a distal end of the endoscopic stapling device  34 .  FIGS. 10A-10E  shows successive steps in the utilization of the device.  
         [0060]     As shown in  FIGS. 10A-10E , stapling device  34  includes elongate tube  38  fixed at a proximal end to handle mechanism  24 . A staple holder  40  similar to staple holder  16  is connected to elongate tube  38  and an actuation assembly which includes a drive wire or rod  42  that activates jaws  40   a  and  40   b  of the staple holder  40 . This actuation mechanism is connected at its proximal end to handle mechanism  24 .  
         [0061]     Handle mechanism  24  is composed of formed plastic or metal components that slide within each other. One set of components  44  controls the opening and closing of the staple holder jaws  40   a  and  40   b  another set of components  46  controls the sliding of a push bar  48  that advances a backbone  50  over a staple  52  once the staple has been inserted and closed in target tissue. Backbone  50  and staple  52  have interacting locking structures as described above particularly with references to  FIGS. 3-5 .  
         [0062]     Drive wire or rod  42  effectuates the closing of jaws  40   a  and  40 . Like jaws  16   a  and  16   b , jaws  40   a  and  40   b  may be provided with a biasing spring (not shown) tending to open the jaws upon an ejection thereof into a body cavity. Alternatively, drive wire or rod  42  may be used to both open and close the jaws  40   a  and  40   b  in response to distal and proximal movement of actuation component  44  under the direct control of the operator. Jaws  40   a  and  40   b  may be connected to another tube (not shown) internal to tube  38 .  
         [0063]      FIG. 10 A  shows staple  52  and staple holder  40  disposed within the distal end of tube  38  prior to ejection therefrom during an endoscopic or laparoscopic stapling procedure.  FIG. 10B  shows staple  52  and staple holder  40  opened by a controlled distal movement of actuation components  44  and  46  (arrows  45  and  47  in  FIGS. 10A and 10B ). Staple  52  is now opened with backbone  50  disposed proximally thereof, as discussed above with reference to  FIG. 4 . After an insertion of the opened staple holder  40  and staple  52  into a desired tissue site (see  FIGS. 7 and 8 , actuation component  44  is manipulated to close jaws  40   a  and  40   b  and actuation component  46  is pushed in the distal direction, as indicated by an arrow  54  to cause push bar  48  to advance backbone  50  over staple  50  ( FIGS. 10C and 10D ), as discussed above with reference to  FIGS. 5 and 8 . After the locking of staple  52  by backbone  50 , actuation components  44  and  46  are moved in opposing directions, as indicated by arrows  56  and  58  in  FIG. 10E , to eject backbone  50  and close jaws  40   a  and  40   b.    
         [0064]      FIG. 11  is a perspective view of a staple tray  18 , which is a formed holder that contains additional staples  10  (or  52 ) and backbones  60  and facilitates in the reloading of staple holder  16  (or  40 ). Staple tray  18  has a base  62  formed with a series of holes or slots  64 , which accept the distal tips of staples  10  in the open configuration thereof. A second level  68  of staple tray  18  is positioned securely over the base  62  of the staple tray  18  and has a series of aligned holes  66  that securely hold backbones  60  in proximal contact to staples  10 . The second tray level  68  thus serves as an orientation structure for maintaining a plurality of backbones  60  at proximal ends of the staples  10  in the base  62  of the tray  18 . When reloading staple holder  16 , the staple holder is placed at the proximal end of backbone  60 , push bar  22  (or  48 ) is retracted and staple holder  16  is slid over staple  10  capturing staple  10  in the opposing slots  16   c ,  16   d  on the inside surfaces of the staple holder jaws  16   a  and  16   b.    
         [0065]     Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.  
         [0066]     Having thus described the invention, what is desired to be protected by Letters Patent is presented in the subsequently appended claims.