Patent Abstract:
A surgical stapling device is configured for use in open and/or laparoscopic surgical procedures. The device includes a staple holder with a first support element and a second support element for supporting a beltless continuous staple chain. Each staple of the staple chain is configured to be frangibly separated from the staple chain to pierce and secure a target tissue when each staple is deployed. The device also includes a plurality of standoff members wherein each of the plurality of standoff members is configured to support one of each staple of the staple chain when the one of each staple is being deployed. The surgical stapling device may be a cartridge-based or a cartridge-less based staple device.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This patent application claims priority to Provisional U.S. Patent Application Ser. No. 61/781,196, filed Mar. 14, 2013, which is herein incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The invention generally relates to surgical staplers and stapling devices. 
     BACKGROUND 
     An endocutter is a surgical tool that staples and cuts tissue to transect that tissue while leaving the cut ends hemostatic. An endocutter is small enough in diameter for use in minimally invasive surgery, where access to a surgical site is obtained through a trocar, port, or small incision in the body. A linear cutter is a larger version of an endocutter, and is used to transect portions of the gastrointestinal tract. A typical endocutter receives at its distal end a disposable single-use staple cartridge with several rows of staples, and includes an anvil to oppose and deform the deployed staples in the staple cartridge. The staples may be held in individual pockets, with staple drivers underneath each staple. As a wedge advances into the cartridge, that wedge sequentially pushes a number of staple drivers upward, and the staple drivers in turn both linearly push each corresponding staple upward out of its pocket, deforming it against an anvil. 
     During actuation of an endocutter, the cartridge fires all of the staples that it holds. In order to deploy more staples, the endocutter must be moved away from the surgical site and removed from the patient, after which the old cartridge is exchanged for a new cartridge. The endocutter is then reinserted into the patient. 
     SUMMARY OF THE INVENTION 
     A surgical stapling device is configured for use in open and/or laparoscopic surgical procedures. The device includes a staple holder with a first support element and a second support element for supporting a continuous staple chain. Each staple of the staple chain is configured to be frangibly separated from the staple chain to pierce and secure a target tissue when each staple is deployed. The device also includes a plurality of standoff members wherein each of the plurality of standoff members is configured to support one of each staple of the staple chain when the one of each staple is being deployed. The surgical stapling device may be a cartridge-based or a cartridge-less staple device. 
     As mentioned, a staple holder of the surgical stapling device may include a first support element and a second support element for supporting a continuous staple chain that is belt-less or without a feeder belt. The first support element may provide lateral support to the staple chain, while the second support element provides vertical support to the staple chain. In addition, each of the plurality of standoff members may be respectively coupled to the first support element along various locations or positions along a length or surface of the first support element. The arrangement is such that each staple of the staple chain is being held in place by a respective or corresponding standoff member while one of each staple of the staple chain is being deployed. The arrangement of the staple chain is that each staple of the staple chain is frangibly coupled to at least one other staple of the staple chain. The staple chain is comprised of an end portion of one of each staple of the staple chain being frangibly coupled to a head portion of another one of each staple of the staple chain. One of each staple of the staple chain is frangibly separated from another one of each staple of the staple chain at a frangibly connection region, location, or point when the one of each staple of the staple chain is being deployed. The frangibly connection region, location, or point is where an end portion of one of each staple of the staple chain meets, connects, couples, or joins to a head portion of another one of each staple of the staple chain. A wedge element, being deployed within the staple holder, configured to directly act on or push each staple of the staple chain to deploy each staple. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a perspective view of an exemplary cartridge and exemplary wedge assembly. 
         FIG. 2  illustrates a top cutaway view of the exemplary cartridge of  FIG. 1 . 
         FIG. 3  illustrates a perspective cutaway view of the exemplary cartridge of  FIG. 1 . 
         FIG. 4  illustrates a side cross-section view of the exemplary cartridge of  FIG. 1 , with staples omitted for clarity. 
         FIG. 5  illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a different rigid rack. 
         FIG. 6  illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a single flexible rack. 
         FIG. 7  illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a single flexible rack, where staples extend from the flexible rack. 
         FIG. 8  illustrates a top view of an exemplary feeder belt configured to engage a gear. 
         FIG. 9  illustrates a side view of an exemplary continuous feeder belt. 
         FIG. 10  illustrates a side view of an exemplary belt-less staple chain. 
         FIG. 11  illustrates a close-up side view of the exemplary belt-less staple chain. 
         FIG. 12  illustrates a perspective view of an exemplary belt-less staple chain. 
         FIG. 13  illustrates a close-up perspective view of the exemplary belt-less staple chain. 
         FIG. 14  illustrates one example of mounting an exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less stapling device. 
         FIG. 15  illustrates a close-up view of one example of mounting the exemplary belt-less staple chain. 
         FIG. 16  illustrates a perspective view of mounting an exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less staple device. 
         FIG. 17  illustrates a close-up perspective view of mounting the exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less staple device. 
         FIG. 18  illustrates a further close-up view of the belt-less staple chain and mounting provisions. 
         FIG. 19A  and  FIG. 19B  illustrate one example of belt-less staple chains mounted in a staple cartridge. 
         FIG. 20A  through  FIG. 20E  illustrate staple deployment of staples on an exemplary belt-less staple chain by a wedge element. 
         FIG. 21A  and  FIG. 21B  illustrate one example of an end effector or distal portion of a stapling device using a belt-less staple chain. 
         FIG. 22A  and  FIG. 22B  illustrate another example of an end effector or distal portion of a stapling device using a belt-less staple chain. 
         FIG. 23  illustrates one example of a stapling device using a belt-less staple chain. 
     
    
    
     The use of the same reference symbols in different figures indicates similar or identical items. 
     DETAILED DESCRIPTION 
     U.S. patent application Ser. No. 12/400,790, entitled “True Multi-Fire Surgical Stapler Configured to Fire Staples of Different Sizes”, filed on Mar. 9, 2009 (the “Feeder Belt Document”), is hereby incorporated by reference herein in its entirety. The Feeder Belt Document describes exemplary feeder belts used in a surgical stapler, to which plurality of staples are frangibly connected. Because new staples are fed to an end effector of a surgical stapler by the feeder belts for sequential deployment, the surgical stapler of the Feeder Belt Document does not need or utilize plurality of single-use cartridges in order to deploy multiple sets of staples. 
     As is commonly used in the medical device industry, particularly in the surgical stapler business, the term “cartridge” means, and is expressly defined in this document to mean, a portion of a surgical stapler that holds at least one staple, and that is insertable within and releasably connected to a remainder of the surgical stapler. Referring to  FIG. 1 , an exemplary cartridge  2  is shown, along with an exemplary wedge assembly  4  and knife  6 . The cartridge  2  may be utilized in conjunction with any surgical stapler that is capable of receiving it, and that includes at least a wedge assembly  4  capable of moving into the cartridge  2  to deploy staples (as described in greater detail below) and then moving out of the cartridge  2  to allow the spent cartridge  2  to be removed from the surgical stapler. The cartridge  2  may be received in a remainder of a surgical stapler in any suitable manner, such as by a pressure fit or interference fit; passively or affirmatively; or in any other suitable manner. The cartridge  2  may be received at the distal end of a remainder of the surgical stapler, and/or along the side of a remainder of the surgical stapler. The cartridge  2  may be useful in conjunction with an articulated surgical stapler having an articulation proximal to the location at which the cartridge is attached to the stapler. Such an articulation may be, for example, as described in U.S. patent application Ser. No. 12/400,760, entitled “Articulated Surgical Instrument”, filed on Mar. 9, 2009, or in U.S. patent application Ser. No. 12/612,614, entitled “Surgical Stapler with Variable Clamp Gap”, filed on Nov. 4, 2009, both of which are hereby incorporated by reference in their entirety. 
     The cartridge  2  may be shaped in any suitable manner. As one example, the cartridge  2  may include an upper surface  8 . The upper surface  8  may be generally flat, and generally rectangular. However, the upper surface  8  need not be generally flat along all or part of its area, and may be shaped in a manner other than rectangular. Further, the upper surface  8  need not be a discrete part of the cartridge  2 , and instead simply may be a portion of a larger surface or area of the cartridge  2 . The upper surface  8  of the cartridge  2  may include a plurality of openings  10  defined completely therethrough. As described in greater detail below, each opening  10  may be aligned with a corresponding staple, such that a staple may be deployed through each opening  10 . Each opening  10  may be generally longitudinally-oriented, and generally rectangular in shape. Alternately, the orientation and/or shape of at least one opening  10  may be different from the other openings  10 . The openings  10  may be organized into one or more generally-longitudinally-oriented rows, corresponding to the locations of staples in the cartridge  2 . As another example, the openings  10  may be interconnected to form one or more larger openings, such that more than one staple may be deployed through a single opening  10 . Alternately, the upper surface  8  may be omitted altogether, thereby rendering openings  10  superfluous. 
     Referring also to  FIGS. 2-4 , the cartridge  2  also may include one or more rails  12 . The rails  12  may be oriented generally longitudinally, and may be shaped generally as rectangular solids. At least one rail  12  may be dimensioned greater in lateral width than in vertical height, as seen most clearly in  FIG. 3 . As another example, at least one rail  12  may be oriented and/or shaped in any other suitable manner. The rails  12  may be spaced laterally apart from one another. The rails  12  may be fabricated from any suitable material, and in any suitable manner. At least one rail  12  may be vertically spaced apart from the upper surface  8  of the cartridge  2  by a gap  14 . One or more pins  17  may extend from at least one rail  12  across the gap  14  to the upper surface  8 . The pins  17  may be fabricated integrally with the corresponding rail  12  and/or upper surface  8 , or may be fabricated separately and later connected thereto. At least one pin  17  may be generally cylindrical in shape. However, at least one pin  17  may be shaped differently. The pins  17  advantageously are shaped the same as one another, but at least one pin  17  may be shaped differently than at least one other pin  17 . 
     A plurality of staples  16  may be affixed to and frangibly separable from the cartridge  2 . The staples  16  may be shaped substantially in the same manner as the staples described in the Feeder Belt Document, or may be shaped in any other suitable manner. Each staple  16  may have a free end  18 , and an opposite end  20  that is connected to a stem  22 . The portion of the staple  16  between the free end  18  and the opposite end  20  may be referred to as the tine  24 . The stem  22  of at least one staple  16  may be substantially perpendicular to the tine  24  of that staple  16 . As another example, the stem  22  and tine  24  of a staple  16  may be oriented at a different angle to one another. The stem  22  may be substantially planar and rectangular, but may be shaped differently if desired. Each tine  24  may be fixed to the corresponding stem  22 . Advantageously, the tine  24  and corresponding stem  22  are integral, and may be fabricated by stamping a piece of flat sheet metal, then bending the tine  24  and the stem  22  to the desired angle relative to one another. Advantageously, each staple  16  is positioned on a corresponding rail  12 , such that the stem  22  is positioned on top of that rail  12 . The thickness of the stem  22  may be substantially the same as the height of the gap  14  between each rail  12  and the upper surface  8 . Alternately, the thickness of at least one stem  22  may be less than the height of the gap  14  between each rail  12  and the upper surface  8 . Each staple  16  may be fixed to the upper surface  8  of the cartridge and/or to a rail  12 , in any suitable manner. As one example, at least one stem  22  may include at least one aperture  26  defined therethrough. That aperture  26  may receive a corresponding pin  17  that extends from the upper surface  8  to a rail  12 . As another example, at least one stem  22  may be welded to the top of a corresponding rail  12  and/or to the bottom of the upper surface  8 . As another example, at least one stem may be affixed to the top of a corresponding rail  12  and/or to the bottom of the upper surface  8  by adhesive. As another example, at least one stem  22  may be pressure-fit between the upper surface  8  and the corresponding rail  12 . As another example, at least one stem  22  may be fixed to a corresponding rail  12  and/or the upper surface  8  in two or more ways, such as, for example, by welding and by receiving a pin  17  through an aperture  26  in the stem  22 . At least one staple  16  may be fabricated separately from a remainder of the cartridge  2 , then affixed to the cartridge  2  as set forth above. Alternately, at least one staple  16  may be integral with a remainder of the cartridge  2 . 
     The staples  16  may be arranged in the cartridge  2  in any suitable manner. As one example, one or more staples  16  may be arranged against a corresponding rail  12 , with each stem  22  fixed to the corresponding rail  12 . The staples  16  may be arranged relative to the rail  12  and to one another such that the tine  24  extending from a particular staple  16  is positioned on one lateral side of the rail  12 , and the tine  24  extending from each longitudinally-adjacent staple  16  is positioned on the other lateral side of the rail  12 . In this way, the tines  24  alternate sides relative to the rail  12  longitudinally along the rail  12 , as seen most clearly in  FIGS. 2-3 . As another example, each staple  16  may include a single stem  22 , with two tines  24  extending from it. Each tine  24  may extend from a lateral side opposed to the other. The stem  22  may be positioned on top of a rail  12 , with each stem  22  fixed to the corresponding rail  12 , and with each tine  24  positioned on a different lateral side of the corresponding rail  12 . One tine  24  may be positioned longitudinally distal to the other tine  24  extending from the same stem  22 . Such staples  16  may be arranged relative to the rail  12  such that the tines  24  alternate sides relative to the rail  12  longitudinally along the rail  12 . As another example, at least one staple  16  is integral with the upper surface  8 , and is affixed to a remainder of the upper surface  8  at the end  20  of the tine  24 . In such a configuration, the staple  16  may be fabricated by punching, stamping, or otherwise dislodging it from the upper surface  8 , such that the staple  16  extends from one end of a corresponding opening  10  in the upper surface  8 , and the opening  10  results from the fabrication of the staple  16  associated with it. Further, in such a configuration, the stem  22  may be omitted from the staple  16 . Regardless of the particular configuration of the staples  16 , each tine  24  may be positioned adjacent to a corresponding opening  10  in the upper surface  8 , and/or may be affixed to the upper surface  8  in proximity to the corresponding opening  10 . 
     At least part of each staple  16  may be frangibly affixed to a remainder of the cartridge  2 . “Frangibly affixed” is defined to mean that at least part of each staple  16  is fixed to a remainder of the cartridge  2  in such a manner that it must be sheared or otherwise broken off from a remainder of the cartridge  2  to be removed therefrom. As one example, at least one staple  16  may be frangible at the junction between the stem  22  and the tine  24 . Such a junction may have a weakened area to facilitate frangibility. As another example, at least one staple  16  may remain intact during deployment, and the stem  22  of the staple  16  is frangible from the corresponding rail  12  and/or the upper surface  8 . As another example, where the tine  24  is integral with the upper surface  8 , the tine  24  may be frangible at the junction between the tine  24  and the upper surface  8 . 
     The cartridge  2  may be actuated, and the staples  16  deployed, substantially as set forth in the Feeder Belt Document, with the following general differences. The wedge assembly  4  includes one or more wedges  30  configured generally as set forth in the Feeder Belt Document. Initially, the wedge or wedges  30  may be positioned proximal to the cartridge  2 . In this way, the wedge or wedges  30  do not interfere with the insertion of the cartridge  2  into a remainder of the surgical stapler. The cartridge  2  may be inserted into the stapler, or may already be present in the stapler, prior to actuation of the stapler. The wedge assembly  4  is moved distally, advantageously by sliding. As the wedge assembly  4  moves distally, it slides the wedge or wedges  30  distally as well. Advantageously, one wedge  30  slides along a corresponding row of staples  16  to sequentially deform staples  16  outward through the corresponding openings  10  in the upper surface  8 , and then break staples  16  from the cartridge  2 . Such deformation and later breakage of the staple may be as set forth generally in the Feeder Belt Document. As one example, the stem  22  of one or more staples  16  is held substantially in place by its affixation to a corresponding rail  12  and/or to the upper surface  8 , as set forth above. As a wedge  30  slides distally relative to the staple  16 , the wedge  30  first engages the tine  24  of that staple  16 , causing the tine  24  to move upward and to rotate about the junction between the tine  24  and the stem  22 . Rotation of the tine  24  upward causes the tine  24  to move up through a corresponding opening  10  in the upper surface  8 , through tissue, and then move into contact with an anvil (not shown), such as set forth in the Feeder Belt Document. Contact between the tine  24  and the anvil deforms the tine  24  to its closed configuration. As the wedge  30  continues to move distally relative to the staple  16 , both the wedge  30  and the tine  24  may be shaped such that the wedge  30  may continue to contact and exert force on the tine  24  after the tine  24  has been deformed. This force increases until the tine  24  is broken, sheared or otherwise separated from the stem  22 . As another example, this force increases until the stem  22  is broken, sheared or otherwise separated from a remainder of the cartridge  2 , such as from a corresponding rail  12  and/or the upper surface  8  of the cartridge  2 . The wedge  30  thereby may sequentially separate the frangible staples  16  from a remainder of the cartridge  2 . 
     A knife  6  also may be connected to the wedge assembly  4 , and may slide upward through the corresponding knife slot  32  in the upper surface  8  as the wedge assembly  4  moves distally through the cartridge  2 . The knife  6  may be actuated, and may cut tissue, substantially as set forth in the Feeder Belt Document. Optionally, the knife  6  may be omitted from the wedge assembly  4 , if desired. The knife  6  may be configured to move into the cartridge  2 , then move upward through and out of the knife slot  32 , then slide along the knife slot  32 , then move downward through the knife slot  32 . In this way, the knife  6  may be held in a position in which it does not extend through the knife slot  32  both before and after it has cut tissue, in order to enhance safety for the user and the patient. 
     After the wedge assembly  4  has been actuated to deploy one or more of the staples  16 , the cartridge  2  is spent. The wedge assembly  4  then may be retracted proximally through and then out of the proximal end of the cartridge  2 . The spent cartridge  2  then may be removed from a remainder of the surgical stapler. If desired, a new cartridge  2  may then be inserted into the surgical stapler in place of the previous, spent cartridge  2 . The new cartridge  2  may be actuated substantially as described above. 
     In addition, Cardica, Inc. of Redwood City, Calif. has developed a true multi-fire endocutter that is capable of firing multiple times without the need to utilize single-use-cartridges. That is, the true multi-fire endocutter is a cartridge-less device capable of firing multiple sets of staples without the need of reloading a new cartridge of staples for repeated firing. An example of such an endocutter is described in U.S. patent application Ser. No. 12/263,171, entitled “Multiple-Use Surgical Stapler”, filed on Oct. 31, 2008 (the “Endocutter Application”), which is hereby incorporated by reference in its entirety. 
     Referring to  FIG. 5 , the Endocutter Application, among other items, discloses a feeder belt  52  to which a plurality of staples  54  are frangibly attached. The feeder belt  52  bends around a pulley  56  at its distal end. Each end of the feeder belt  52  is connected to a different rigid, toothed rack  58 , and each rack engages a gear  50 . The racks  58  are substantially rigid, and as a result, advancement of one rack  58  causes the gear  50  to rotate and thereby move the other rack  58  in the opposite direction. The gear  50  is located in a shaft  62  of the tool, between the handle and a distal end of the shaft. Because the racks  58  are substantially rigid, the linear travel of the racks  58  is limited by the length of the shaft  62  and of the handle connected to the shaft. Consequently, the number of firings that can be made by the tool is limited by the linear distance that the racks  58  can travel within the shaft  12  and structure connected to the shaft  12 . 
     Continuous Feeder Belt Assembly with Flexible Rack 
     Referring to  FIG. 6 , a feeder belt  52  bends around a pulley  56  at its distal end, such that an upper portion  64  of the feeder belt  52  is above and spaced apart from a lower portion  66  of the feeder belt  52 . The upper portion  64  and lower portion  66  of the feeder belt  52  may be, but need not be, substantially parallel to one another. The upper portion  64  and lower portion  66  of the feeder belt  52  each have a proximal end, and the proximal end of each portion  64 ,  66  may be connected to a flexible rack  68 . That is, the feeder belt  52  is connected at each end to a flexible rack  68 . The combination of the feeder belt  52  and the flexible rack  68  may be referred to as the belt assembly  70 . The belt assembly  70  is continuous, meaning that the belt assembly  70  defines a continuous, unbroken loop. The flexible rack  68  may be flexible in any suitable manner. As one example, the flexible rack  68  may be made from a flexible material with sufficient strength and other material properties to allow it to bend around the gear  50 , and to be attached to and exert tension on the feeder belt  52 . As another example, the flexible rack  68  may be a chain or other mechanism with individual, small links that are themselves rigid but that are collectively flexible. As another example, the flexible rack  68  may be fabricated from nickel-titanium alloy or other superelastic material. 
     Where the flexible rack  68  is utilized, the gear  50  may be located at the proximal end of the continuous belt assembly  70 . In this way, the gear  50  may be utilized to tension the feeder belt  52  between the gear  50  and the pulley  56  at the distal end of the feeder belt  52 . If so, the gear  50  may be located at or near the proximal end of the shaft  62 , which may be held within a handle  74 , or may be located proximal to or outside the shaft  62  inside the handle  74  or other structure attached to the shaft  62 . Further, the initial position of the feeder belt  52  may be as shown in  FIG. 6 , where staples  54  extend from the upper portion  64  of the feeder belt  52  along substantially all of the upper portion  64 . In this way, the feeder belt  52  is able to include more staples  54  along its length than the feeder belt  52  of  FIG. 5 , such that more staple firings can be made with a single feeder belt  52 . 
     The feeder belt  52  may be assembled into an endocutter or other surgical apparatus, and may be actuated by that endocutter or other surgical apparatus, substantially as described in the Endocutter Application. Optionally, the gear  50  may be directly driven by a handle such as described in the Endocutter Application, thereby reducing the number of parts and simplifying the overall assembly relative to that handle. 
     Optionally, referring also to  FIG. 7 , staples  54  may be frangibly connected to the flexible rack  68  as well as to the feeder belt  52 . The staples  54  may be connected to the flexible rack  68  in substantially the same manner as described in the Endocutter Application. Alternately, the staples  54  may be connected to the flexible rack  68  in any other suitable manner. Where staples  54  are carried by the flexible rack  68 , the upper portion  64  of the feeder belt  52  may be spaced apart from the lower portion  66  of the feeder belt  52  a distance sufficient that the staples  54  extending from each portion  64 ,  66  do not interfere with or engage one another. Alternately, the staples  54  instead, or also, may be laterally spaced relative to one another, such that in the initial position of the feeder belt  52 , the staples  54  extending from the upper portion  64  of the continuous belt assembly  70  are laterally spaced a first distance from a longitudinal centerline of that continuous belt assembly  70 , and the staples  54  extending from the lower portion  66  of the continuous belt assembly  70  are laterally spaced a second distance from a longitudinal centerline of that continuous belt assembly  70 , where the first distance and the second distance are sufficiently different from one another that the staples  54  extending from different portions  64 ,  66  pass by one another without colliding or interfering with one another during actuating of the continuous belt assembly  70 . That is, the continuous belt assembly  70  is arranged in any suitable manner such that the staples  54  along the feeder belt  52  and the flexible rack  68  of the continuous belt assembly  70  do not interfere with one another. 
     Alternately, where staples  54  extend from the flexible rack  68 , the feeder belt  52  may be omitted, such that the flexible rack  68  is continuous and holds and deploys all of the staples  4 . 
     Rack-Less Continuous Feeder Belt Assembly 
     Referring to  FIG. 8 , a feeder belt  52  such as described in the Endocutter Application may include a plurality of apertures  76  defined therein. The apertures  76  may be sized, shaped and spaced apart from one another such that they engage teeth on the gear  50 . The feeder belt  52  is sufficiently flexible to wrap around and be driven around the pulley  56 , and consequently is sufficiently flexible to wrap around and be driven by or around the gear  50 . In such an embodiment, the rack or racks  58 ,  68  may be omitted, and the feeder belt  52  is itself continuous and forms a continuous loop, as shown in  FIG. 9 . Alternately, the apertures  76  may be omitted, and the underside of the feeder belt  52  may include teeth similar to one of the racks  58 ,  68  configured to engage the gear  50 . Alternately, the apertures  76  may be omitted, and the feeder belt  52  may be held in tension or otherwise manipulated such that the flat feeder belt  52  is capable of being advanced without the use of features on the feeder belt  52  configured to engage a gear, or without the use of a rack  58 ,  68  connected to or otherwise engaging the feeder belt  52 . 
     Belt-Less Staple Chain 
     Referring to  FIG. 10  and  FIG. 12 , a continuous belt-less staple chain  100  may be used for both cartridge and cartridgeless applications in stapling devices, an example of a stapling device  230  is illustrated in  FIG. 23 . The belt-less staple chain  100  may not require a feeder belt, hence it is belt-less. Instead, the staples  54  are frangibly connected to each other such that they do not need to be connected to a feeder belt. For example, a substantially sharp-end or tail-end  102  of one staple  54  is frangibly connected to a substantially dull-end or head-end of the next staple  54  in the staple chain  100  at a frangible connection  106 , as illustrated in  FIG. 11  and  FIG. 13 . 
       FIG. 14  and  FIG. 16  illustrate one example of positioning or mounting the belt-less staple chain  100 , in a cartridge or a cartridge-less system. For example, the belt-less staple chain  100  may be supported by a lateral support element  142  and a bottom support element  144 , as illustrated in  FIG. 14 ,  FIG. 15 ,  FIG. 16 , and  FIG. 17 . The lateral support element  142  may be a support rail, a support strip, or any suitable support element that can provide lateral support to the belt-less staple chain  100 . The lateral support element  142  may be an element or component of a staple cartridge, in a cartridge-based staple device. Alternatively, the lateral support element  142  may be an element or component within an application shaft of a cartridge-less based staple device. As described and can be appreciated, the bottom support element  144  may be a surface of a staple cartridge, such as a bottom surface or any surface that can provide vertical support to the belt-less staple chain  10 , in either a cartridge-based staple device or a cartridge-less based staple device. 
       FIG. 18  illustrates a close-up view of the connection point between two staples in a belt-less staple chain  100 . As illustrated, a tail-end portion  102  of a first staple  54  is connected to a head-end portion of a second staple  54  by way of a frangible connection  106 . To be discussed in more detail, a stand-off element or boss element  152  (illustrated in  FIG. 15  and  FIG. 18 ) also acts as a support element to the belt-less staple chain that substantially holds the second staple  54  in place while the first staple  54  is deployed by a wedge element  194 . 
       FIG. 19A  and  FIG. 19B  illustrate one example of structural elements that may be involved in a cartridge-based staple device using the belt-less staple chain. Also, similar or equivalent structural elements may be incorporated in a cartridge-less based staple device using the belt-less staple chain. Such similar or equivalent structural elements may be incorporated into an end-effector or staple deployment component of an endocutter, as illustrated in  FIG. 21  through  FIG. 23 . 
       FIG. 20A  through  FIG. 20E  illustrate one example of staple deployment process. As illustrated in  FIG. 20A  and  FIG. 20B , the process starts with advancement of one or more wedges  194  to engage one or more staples  54  in one or more belt-less staple chains  100  in a cartridge-based or cartridge-less based staple device or system. As illustrated in  FIG. 20C  through  FIG. 20E , the wedge element  194  may be advanced progressively forward against a first staple  54 . The forward advancement of the wedge element  194  causes the head-end portion  102  of the staple  54  to pivot against the stand-off element  152  and the tail-end portion  104  to swing upwardly in a substantially arc-like motion. Referring to the close-up view of  FIG. 18 , the head-end portion of the second staple  54  is being held substantially in place by a corresponding stand-off element or pivot element  152 , such as the upward motion of the tail-end portion of the first staple  54  is being resisted by the substantially stable or held-in-placed of the head-end portion of the second staple  54 . Accordingly, as the wedge element  152  continue to urge against the first staple  54 , the first staple  54  frangibly separates from the second staple  54  at the frangible connection  106  between the two staples  54 , as illustrated in  FIG. 20C , and the tail-end portion  104  continues its upward arc-like motion or travel. As a staple device is deployed in a surgical procedure, the upward arc-like travel of the tail-end portion  104  of the staple  54  would encounter and pierce tissue. In an application setting, as the staple  54  is deployed by the wedge element  194 , the tail-end portion  104  would encounter the staple pocket elements  204  of an anvil  202  after piercing tissue. The staple pocket element  204  of the anvil  202  would deform the initially open configuration of the staple  54  into a closed staple, see  FIG. 20D  and  FIG. 20E , thus stapling the tissue and leaving it hemostatic. 
       FIG. 21A  and  FIG. 21B  illustrate an anvil element  202  and a staple holder element  212  of a staple device. Typically, a staple holder element  212  holds and deploys staples, such as one or more belt-less staple chains, and an anvil element  202  engages with one or more deployed staple  54  and deforms it from an initial configuration to a deployed configuration. An initial configuration may be an “open” configuration similar to the ones illustrated  FIG. 10  through  FIG. 20E . A deployed configuration may be a “closed” configuration similar to the one illustrated in  FIG. 20E , where a deployed staple  54  has been deformed by a staple pocket element  204 .  FIG. 22A  and  FIG. 22B  illustrate the open-jaw configuration for the anvil  202  and stapler holder  212 . In the open-jaw configuration, a staple cartridge holder  224  is illustrated with its covers, shell, or skin, and separate cartridge holder  222  is illustrated without its covers, shell, or skin.  FIG. 23  illustrates a staple device  230  where the belt-less staple chain  100  can be used. Similar or equivalent structural configuration and deployment arrangements are applicable to both a cartridge-base stapling device and a cartridge-less stapling device. 
     While the invention has been described in detail, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed without departing from the spirit and scope of the present invention. It is to be understood that the invention is not limited to the details of construction, the arrangements of components, and/or the methods set forth in the above description or illustrated in the drawings. Statements in this disclosure are merely exemplary; they are not and cannot be interpreted as limiting the spirit and scope of the claims. Further, the figures are merely exemplary and not limiting. Topical headings and subheadings are for the convenience of the reader only. They should not and cannot be construed to have any substantive significance, meaning or interpretation, and should not and cannot be deemed to indicate that all of the information relating to any particular topic is to be found under or limited to any particular heading or subheading. Therefore, the invention is not to be restricted or limited; instead, it is to be interpreted in accordance with the following claims and their equivalents.

Technology Classification (CPC): 0