Abstract:
A surgical apparatus may include a cartridge, and surgical staples affixed to and frangibly separable from that cartridge. A method for surgical stapling utilizing that apparatus may include providing at least one wedge; and moving at least one wedge into the cartridge, where that moving deforms and then shears from the cartridge at least one staple. A method of manufacturing an apparatus for use with a surgical stapler may include fabricating a cartridge configured to be received by the surgical stapler; fabricating staples; and fixing the staples to the cartridge.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/571,319 (attorney docket no. 350), filed Aug. 9, 2012, which, in turn, is a divisional of U.S. patent application No. 12/683,382 (attorney docket no. 292), filed Jan. 6, 2010, now U.S. Pat. No. 8,261,958, issued Sep. 11, 2012, both of which are herein incorporated by reference in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention generally relates to surgical staplers and stapling. 
       BACKGROUND 
       [0003]    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 cartridge with several rows of staples, and includes an anvil opposed to the 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. The manufacturing process required to place those small individual staples and staple drivers in the corresponding small pockets is difficult, and the number of parts involved complicates the system and requires a minimum size of cartridge that may be larger than optimally desired. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]      FIG. 1  is a perspective view of an exemplary cartridge and exemplary wedge assembly. 
           [0005]      FIG. 2  is a top cutaway view of the exemplary cartridge of  FIG. 1 . 
           [0006]      FIG. 3  is a perspective cutaway view of the exemplary cartridge of  FIG. 1 . 
           [0007]      FIG. 4  is a side cross-section view of the exemplary cartridge of  FIG. 1 , with staples omitted for clarity. 
       
    
    
       [0008]    The use of the same reference symbols in different figures indicates similar or identical items. 
       DETAILED DESCRIPTION 
       [0009]    U.S. patent application Ser. No. 12/400,790, 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 a 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 a plurality of single-use cartridges in order to deploy multiple sets of staples. 
         [0010]    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, filed on Mar. 9, 2009, or in U.S. patent application Ser. No. 12/612,614, filed on Nov. 4, 2009, both of which are hereby incorporated by reference in their entirety. 
         [0011]    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. 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. 
         [0012]    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 . 
         [0013]    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 . 
         [0014]    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 . 
         [0015]    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 . 
         [0016]    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 . 
         [0017]    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. 
         [0018]    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. 
         [0019]    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 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 method set forth in the above description or illustrated in the drawings. Statements in the abstract of this document, and any summary statements in this document, are merely exemplary; they are not, and cannot be interpreted as, limiting the 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 except in accordance with the following claims and their legal equivalents.