Abstract:
A surgical staple device which accommodates various tissue thicknesses by employing unique modified surfaces with increased friction is disclosed. The staple device includes a U-shaped staple body with modified surfaces on its legs, whereas the modified surfaces may be designed as ratchet teeth, barbs, hooks, grooves, and channels. The staple device further includes a footplate to receive and engage the legs.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a non-provisional and claims benefit to U.S. Provisional Application No. 61/397,987 entitled “Ratcheting Staple” filed on Jun. 18, 2010, and U.S. Provisional Application No. 61/516,097 entitled “Surgical Staple” filed on Mar. 29, 2011, both of which are hereby incorporated by reference. 
     
    
     FIELD 
       [0002]    The present application relates to surgical devices and more particularly to a ratcheting staple, which can be used to securely join tissues and blood vessels. 
       BACKGROUND 
       [0003]    During a surgical procedure, a conventional surgical staple is typically used to secure tissue sections together. Conventional surgical staples generally have two equal-length legs joined by a cross section. The staples have a general “U-shape” configuration, where the two legs are driven through the tissue secures and then deformed by an anvil to curve back towards the secured tissue. 
         [0004]    The length of the staple legs used in a procedure is often dictated by the amount of tissue to be secured. Therefore, conventional staples come in a variety of sizes that must be continually restocked at medical facilities. Inadequate staple length can cause severe complications if the staple fails to secure the tissue. Such complications often go undiscovered until the patient is out of surgery or away from the medical facility. It is very costly to continually maintain a supply of different staples. In addition, using an inadequate staple length can be very dangerous. 
       SUMMARY 
       [0005]    In one embodiment, a surgical staple device includes a staple body defining a first leg, a second leg, and a base having a first end and a second end. The base has a first leg extending from the first end and a second leg extending from the second end. The first leg has a first surface and the second leg has a second surface, wherein the first surface and the second surface are modified surfaces to prevent retrograde motion of the surgical staple device. A footplate is mechanically engaged to the modified surfaces. The footplate also has a first footplate end defining a first channel to receive the first leg and a second footplate end defining a second channel to receive the second leg. 
         [0006]    In another embodiment, a surgical staple device includes a staple body defining a first leg, a second leg, and a base having a first end and a second end. The first leg extends from the first end and the second leg extends from the second end. The first leg has a first inner surface and a first outer surface and the second leg has a second inner surface and a second outer surface, wherein the first inner surface and the second inner surface face have modified surfaces to prevent retrograde motion of the surgical staple device. A footplate is mechanically engaged to the modified surfaces, the footplate having a first footplate end defining a first channel to receive the first leg and a second footplate end defining a second channel to receive the second leg. 
         [0007]    In yet another embodiment, a surgical staple device includes a staple body defining a first leg, a second leg, and a base having a first end and a second end. The first leg extends from the first end and the second leg extends from the second end. The first leg has a first outer surface and a first outer surface and the second leg has a second outer surface and a second outer surface, wherein the first outer surface and the second outer surface face have modified surfaces to prevent retrograde motion of the surgical staple device. A footplate is mechanically engaged to the modified surfaces, the footplate having a first footplate end defining a first channel to receive the first leg and a second footplate end defining a second channel to receive the second leg. 
         [0008]    In one embodiment, a surgical stapler device includes an elongated shaft having a proximal end and a distal end. A handle is mounted on the proximal end of the elongated shaft and a staple device forming mechanism is mounted on the distal end of the elongated shaft. 
         [0009]    The staple device forming mechanism includes a plurality of staple devices having a staple body defining a first leg, a second leg, and a base having a first end and a second end. The base has a first leg extending from the first end and a second leg extending from the second end. The first leg has a first surface and the second leg has a second surface, wherein the first surface and the second surface are modified surfaces to prevent retrograde motion of the staple body. 
         [0010]    The staple device forming mechanism further includes a footplate mechanism containing a plurality of footplates. Each of the plurality of footplates is configured to engage the modified surfaces of one of the plurality of staple devices. Each of the plurality of footplates has a first footplate end defining a first channel to receive the first leg and a second footplate end defining a second channel to receive the second leg. 
         [0011]    In another embodiment, method for manufacturing a surgical staple device includes modifying a first surface at a first end of an elongated material to form a first modified surface having at least one of a first plurality of projections or a first plurality of recesses. A second surface is modified at a second end of the elongated material to form a second modified surface having at least one of a second plurality of projections or a second plurality of recesses. 
         [0012]    An open-ended staple body is formed from the elongated material by bending the first end to form a first leg and bending the second end to form a second leg. A footplate defining a first channel at proximal end of the footplate and defining a second channel at a distal end of the footplate is provided. The first channel further defines a first pawl and the second channel further defines a second pawl. 
         [0013]    The first channel is configured to slidably engage the first leg and the first pawl is configured to mechanically engage the first modified surface. The second channel is also configured to slidably engage the second leg and the second pawl is configured to mechanically engage the second modified surface. 
         [0014]    In one embodiment, a method for using a surgical staple device includes providing a surgical stapler device including an elongated shaft further having a proximal end and a distal end, a handle mounted on the proximal end of the elongated shaft. The surgical stapler device also has a staple device forming mechanism mounted on the distal end of the elongated shaft and a footplate mechanism mounted on the distal end of the elongated shaft opposite the staple device forming mechanism. The staple device forming mechanism further including a plurality of staple devices having modified surfaces and the footplate mechanism including a plurality of footplates configured to mechanically engage the modified surfaces. 
         [0015]    A first portion of tissue is positioned adjacent to a second portion of tissue and the distal end of the elongated shaft is positioned to enclose the first portion of tissue and the second portion of tissue between the staple device forming mechanism and the footplate mechanism. The handle is manipulated to compress the first portion of tissue and the second portion of tissue between the staple device forming mechanism and the footplate mechanism. At least one of the plurality of staple devices pierces the first portion of tissue and the second portion of tissue and at least one of the plurality of footplates mechanically engages the at least one of the plurality of staple devices compressing the first portion of tissue and the second portion of tissue there between. 
         [0016]    Additional objectives, advantages, and novel features will be set forth in the description which follows or will become apparent to those skilled in the art upon examination of the drawings and detailed description which follows. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a perspective view showing one embodiment of a ratcheting staple and a footplate; 
           [0018]      FIG. 2  is a perspective view showing the ratcheting staple engaged with the footplate; 
           [0019]      FIG. 3  is a cross-sectional view of the ratcheting staple engaged with the footplate; 
           [0020]      FIG. 4  is an elevated perspective view of the footplate; 
           [0021]      FIG. 5  is a is a perspective cross-sectional view of the footplate; 
           [0022]      FIG. 6  is a top-down view of another embodiment of the of the footplate; 
           [0023]      FIG. 7  is a perspective view showing one embodiment of a ratcheting staple and a footplate; 
           [0024]      FIG. 8  is a perspective view showing the ratcheting staple of  FIG. 7  engaged with the footplate. 
           [0025]      FIG. 9  is a perspective view showing one embodiment of a ratcheting staple and a footplate; 
           [0026]      FIG. 10  is a perspective view showing the ratcheting staple of  FIG. 9  engaged with the footplate; 
           [0027]      FIG. 11  is a perspective view showing one embodiment of a ratcheting staple and a footplate; 
           [0028]      FIG. 12  is a perspective view showing the ratcheting staple of  FIG. 11  engaged with the footplate; 
           [0029]      FIG. 13  is a side view showing one embodiment of a stapler device; 
           [0030]      FIG. 14  is a side view showing a sequence of one embodiment of the ratcheting staple being deployed; 
           [0031]      FIG. 15  is a side view showing one embodiment of a stapler device; and 
           [0032]      FIG. 16  is a side view showing a sequence of one embodiment of the ratcheting staple being deployed. 
       
    
    
       [0033]    Corresponding reference characters indicate corresponding elements among the view of the drawings. The headings used in the figures should not be interpreted to limit the scope of the claims. 
       DETAILED DESCRIPTION 
       [0034]    Aspects of the present disclosure include devices and methods for using a ratcheting staple. In particular, the ratcheting staple device includes a staple body having two or more legs surface modifications that mechanically engage with a footplate to prevent retrograde motion of the staple body once secured to tissue. The ratcheting staple can accommodate a variety tissues and tissue thickness. 
         [0035]    The ratcheting staple device may be formed from any appropriate material having desirable rigidness and flexibility appropriate for the intended use. For example, the ratcheting staple device may be composed of metals, alloys, plastics, composites, polymers, among others. The ratcheting staple device may also be composed of degradable materials that will dissolve or be absorbed by surrounding tissue over time. 
         [0036]    Referring to  FIGS. 1-6 , an embodiment of the ratcheting staple device is illustrated and generally indicated as  100 . The ratcheting staple device  100  includes a staple body  102  that is used to puncture the tissue and a footplate  104  to mechanically engage the staple body  102 . The footplate  104  secures the tissue between the staple body  102  and the footplate  104 . 
         [0037]    The staple body  102  includes a base  106  having a first end  108  and second end  110 . Extending from the first end  108  and the second end  110  are a first leg  112  and a second leg  114 , respectively. In one embodiment, the first leg  112  and the second leg  114  extend substantially perpendicular to the base  106 , and terminate in tapered points  116  and  118 . The first and second legs  108  and  110 , respectively, may have a length between approximately 0.5 mm and approximately 10 mm. Preferably, the first leg  112  and the second leg  114  are the same length. 
         [0038]    The first leg  112  includes a modified inner surface  120  that is configured to mechanically engage with the foot plate  104 . For example, the modified inner surface  120  may include ratchet teeth, barbs, grooves, channels, or other recesses. In one aspect, the modified inner surface  120  protrudes from the first leg  112  and is angled toward the base  106 . In another aspect, the modified inner surface  120  may be recessed into the body of the first leg  112 . Although, not shown, the second leg  114  may also include a modified inner surface  120 , similar to the modified inner surface  120  of the first leg  112 . 
         [0039]    In one aspect, the footplate  104  defines a first and second cavity  122  and  124  configured to receive the first leg  112  and the second leg  114 , respectively. The footplate  104  also includes first and second locking members  126  and  128  to mechanically engage the respective modified inner surface  120  for each of the first leg  112  and the second leg  114 . For example, the first and second locking members  126  and  128  may be semi-rigid pawls or unidirectional leaves that are cantilevered from a central portion  130  of the footplate  104 , as shown in  FIG. 2 . The first and second locking members  126  and  128  slidably engage the modified inner surface  120  and pivot away, as indicated by  132  from the base  106  as the footplate  104  travels towards the base  106 . The first and second locking members  126  and  128  cannot pivot towards the base  106 , and therefore the footplate  104  is prevented from traveling in a retrograde motion once mechanically engaged to the modified inner surface  120 . The distance between the base  106  footplate  104 , indicated generally as  134 , can be selectively controlled such that the secured tissue thickness can range between 0.6 mm to 9.0 mm. 
         [0040]    In another aspect, the first and second locking members  126  and  128  may be protrusions that engagingly fit within recesses of the modified inner surface  120 . In this aspect, the recesses reduce the potential for injury to the tissue being secured. 
         [0041]    In yet another aspect, the footplate  104  may not define the first and second cavities  122  and  124 . In this aspect, the first and second legs  112  and  114  are configured to puncture the surface of the footplate  104 , thereby compressively engaging the first and second legs  112  and  114  to prevent retrograde motion along the modified inner surface  120 . 
         [0042]    Referring to  FIGS. 7 and 8 , in some embodiments the ratcheting staple device  100  may have the first leg  112  and the second leg  114  both terminate in flat ends  136  and  138 . In this aspect, the modified inner surfaces  120  are recessed within the first leg  112  and second leg  114 , respectively. Similarly, in  FIGS. 9 and 10 , some embodiments of the ratcheting staple device  100  may have the first leg  112  and the second leg  114  that terminate in chisel-point ends  140  and  142 . 
         [0043]    In one embodiment, shown in  FIGS. 11-12 , the ratcheting staple device, designated  200 , may have a staple body  202  having a base  206 , a first leg  212 , and a second leg  214  with the first leg  212  and second leg  214  defining a modified outer surface  220 . In this aspect, the footplate  204  defines a first and second cavity  222  and  224  configured to receive the first leg  212  and the second leg  214 , respectively. The footplate  204  also includes first and second locking members  226  and  228  to mechanically engage the modified outer surfaces  220  for each of the first leg  212  and the second leg  214 . For example, the first and second locking members  226  and  228  may be semi-rigid pawls or unidirectional leaves that are cantilevered from a peripheral edge  230  of the footplate  204 . The first and second locking members  226  and  228  slidably engage the modified outer surfaces  220  and pivot away from the base  206  as the footplate  204  travels towards the base  206 . 
         [0044]    Referring to  FIGS. 13 and 14 , an embodiment of a stapler device is illustrated and generally indicated as  300 . The stapler device  300  has an elongated body  302  having a proximal end  304  and a distal end  306 . The proximal end of the elongated body  302  is attached to a handle  308  having a pivotable mounted trigger  310 . The trigger  310  is in mechanical communication with a staple forming mechanism  312  attached to the distal end  306  of the elongated body  302 . 
         [0045]    In one aspect, the trigger  310  is in mechanical communication with the staple forming mechanism  312  through a lumen  314  defined by the elongated body  302 . For example, the trigger  310  may be mechanically engaged with the staple forming mechanism  312  through an arrangement of wires, springs, cams, or other components (not shown) such that actuation of the trigger effectuates actuation of the staple forming mechanism  312 . 
         [0046]    The staple forming mechanism  312  includes a staple cartridge  314  axially aligned with the elongated body  302  and an anvil  316  having a footplate cartridge  318 . As shown in the detailed view  320 , the staple cartridge  314  includes one or more staple bodies  102 . The anvil  316  is pivotably attached to the elongated body  302  and is configured to maintain a normal displacement  322  away from the staple cartridge  314 . The anvil  316  rotates about a pivot  324  in response to actuation of the trigger  310 . 
         [0047]    As shown in  FIG. 14 , the actuation of the trigger  310  also causes a beveled ejector  326  for the staple cartridge  314  to engage the staple body  102  and eject the staple body  102  out of the staple cartridge  314 . The staple body  102  is ejected perpendicular to the staple cartridge  314  to engage tissue (not shown), the footplate  104 , and the anvil  316 . In one embodiment, the footplate  104  includes a groove or recess (not shown) on the surface of the footplate  104  facing the anvil  316  to receive the legs  112  and  114  of the staple body  102  as the legs  112  and  114  are curved towards the footplate  104  by the anvil  316 . 
         [0048]    Referring now to  FIGS. 15 and 16 , an embodiment of a stapler device is illustrated and generally indicated as  400 . The stapler device  400  has an elongated body  402  having a proximal end  404  and a distal end  406 . The proximal end of the elongated body  402  is attached to a handle  408  having a pivotable mounted trigger  410 . The trigger  410  is in mechanical communication with a staple forming mechanism  412  attached to the distal end  406  of the elongated body  402 . 
         [0049]    In one aspect, the trigger  410  is in mechanical communication with the staple forming mechanism  412  through a lumen  414  defined by the elongated body  402 . For example, the trigger  410  may be mechanically engaged with the staple forming mechanism  412  through an arrangement of wires, springs, cams, or other components (not shown) such that actuation of the trigger effectuates actuation of the staple forming mechanism  412 . 
         [0050]    The staple forming mechanism  412  includes a circular staple cartridge  414  attached to the distal end  406  of the elongated body  402  and perpendicular to a central axis  700  of the elongated body  402 . As shown in the detailed view  420 , the staple cartridge  414  includes one or more of the staple body  102 . The staple forming mechanism  412  also includes an anvil  416  having a footplate cartridge  418 . The anvil  416  is attached to the elongated body  402  through a piston  424  and is configured to be parallel to and facing the staple cartridge  414 . The anvil  416  is brought into engagement with the staple cartridge  414  upon compression of the piston  424  in response to actuation of the trigger  410 . 
         [0051]    As shown in  FIG. 14 , the actuation of the trigger  410  also causes an ejector (not shown) of the staple cartridge  414  to engage the staple body  102  and eject the staple body  102  out of the staple cartridge  414 . The staple body  102  may be ejected perpendicular to the staple cartridge  414  to engage tissue (not shown), the footplate  104 , and the anvil  416 . 
         [0052]    It is believed that the present disclosure and many of its attendant advantages will be understood by the foregoing description, and it will be apparent that various changes may be made in the form, construction, and arrangement of the components without departing from the disclosed subject matter or without sacrificing all of its material advantages. The form described is merely explanatory, and it is the intention of the following claims to encompass and include such changes. 
         [0053]    While the present disclosure has been described with reference to various embodiments, it will be understood that these embodiments are illustrative and that the scope of the disclosure is not limited to them. Many variations, modifications, additions, and improvements are possible. More generally, embodiments in accordance with the present disclosure have been described in the context of particular implementations. Functionality may be separated or combined in blocks differently in various embodiments of the disclosure or described with different terminology. These and other variations, modifications, additions, and improvements may fall within the scope of the disclosure as defined in the claims that follow. 
         [0054]    Those skilled in the art will appreciate that variations from the specific embodiments disclosed above are contemplated by the invention. The following invention should not be restricted to the above embodiments, but should be measured by the following claims.