Abstract:
A coated surgical fastener is provided for an easy visualization within tissue. The coated surgical fastener includes a core and a relatively non-reflective coating applied about the core. There is also disclosed an illuminated staple cartridge for use with a surgical stapling device having a light source. The illuminated staple cartridge includes a transparent insert and a relatively nontransparent U-shaped outer channel at least partially surrounding the transparent insert. Windows formed in sides of the U-shaped outer channel allow defined amounts of light to project from the sides of the illuminated staple cartridge.

Description:
BACKGROUND 
       [0001]    1. Technical Field 
         [0002]    The present disclosure relates to surgical staples for use in a surgical stapling instrument. More particularly, the present disclosure relates to surgical staples coated to enhance visibility of placement in tissue. The present disclosure further relates to a staple cartridge having internal illumination to enhance visibility of the cartridge&#39;s position in tissue and positioning of the internal components of the staple cartridge. 
         [0003]    2. Background Of Related Art 
         [0004]    During certain surgical procedures various surgical stapling devices are used to apply one or more rows of staples to tissue and, in some cases, cut the tissue between the rows of staples. The visibility of the distal end of the stapling device used within the body of a patient is important to insure proper placement of the stapling device about tissue. The ability to visually monitor the distal end of the surgical stapling device is also useful to determine how much tissue has actually been stapled and/or how much of the tissue has actually been cut by the surgical stapling device. 
         [0005]    The ability to visualize the distal end of the surgical stapling device is more difficult when the surgical stapling device is used endoscopically or laparoscopically. In these situations, the surgical stapling device is inserted into the body through a port in the body. The surgical operation is performed under visualization through an endoscope or laparoscope having a limited field of view. This may make it difficult to verify that the surgical stapling device has functioned properly and to evaluate the integrity of the staple line formed by the surgical stapling device. 
         [0006]    The ability to evaluate the integrity of the staple line may be hindered by the use of conventional staples formed of stainless steel and/or titanium as these materials tend to reflect light back towards the lens in the endoscope or laparoscope obscuring a clear view of the staple line. 
         [0007]    Thus, there is a need for a surgical stapling device having a distal end which can be more visible within the patient&#39;s body during use. There is also a need for a surgical fastener capable of being clearly visualized within the body without reflecting significant amounts of light back towards the viewing device. 
       SUMMARY 
       [0008]    A surgical fastener is formed as a conventional U-shaped surgical staple having a backspan and a pair of legs extending distally from the backspan. Each of the legs terminates in a tissue penetrating tip. The surgical staple is coated with a material configured to enhance the visibility of the surgical staple within tissue while at the same time reducing the reflectivity of the surgical staple. In a specific embodiment, the tissue penetrating tips of the surgical staple are not coated so as to avoid blunting of the sharp tips. 
         [0009]    In an alternative embodiment, the surgical fastener is formed as a helical coil fastener having a sharp distal tissue penetrating tip in a compressed proximal coil facilitating insertion in tissue. The disclosed helical coil fastener is coated to enhance visibility while reducing reflectivity. 
         [0010]    There is also disclosed a staple cartridge for use with a surgical stapling device having a light source. The staple cartridge generally includes a U-shaped outer channel member and a transparent insert positioned within the U-shaped outer channel member. The transparent insert includes a body portion having a tapered leading edge and an upwardly facing surface for emitting light. In a particular embodiment, the U-shaped outer channel is formed with a series of longitudinally extending windows allowing light transmitted through side surfaces of the transparent insert to pass there through. In use, the relative positioning of staple drivers and a knife blade, associated with a surgical stapling device, attenuate the amount of light passing through the transparent insert and out through the windows in the U-shaped outer channel. The sled or pushers will block any light for distal light windows until it progresses past, thus indicating staple line positional status. 
         [0011]    There is also disclosed a surgical stapling device having a staple cartridge to facilitate visual positioning of the distal end of the surgical stapling device within tissue. The staple cartridge is positioned on a distal end of the surgical stapling device such that a light source associated with the surgical stapling device is in position to transmit light to the transparent insert associated with the staple cartridge. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0012]    Various embodiments of the presently disclosed surgical staples and surgical instrument incorporating an illuminated staple cartridge are disclosed herein with reference to the drawings, wherein: 
           [0013]      FIG. 1  is a side view of a coated surgical staple; 
           [0014]      FIG. 1A  is an end view, partially shown in section, of the coated surgical staple of  FIG. 1 ; 
           [0015]      FIG. 2  is a side view of an alternative embodiment of a coated surgical staple; 
           [0016]      FIG. 2A  is a side view, partially shown in section, of the coated surgical staple of  FIG. 2 ; 
           [0017]      FIG. 3  is a perspective view of the distal end of a surgical stapling device positioned about a tubular tissue section; 
           [0018]      FIG. 4  is a perspective view of the distal end of the surgical stapling device and tubular tissue section of  FIG. 3  after stapling and cutting the tubular tissue section; 
           [0019]      FIG. 5  is a perspective view of a surgical stapling device incorporating a staple cartridge to illuminate the distal end of the surgical stapling device; 
           [0020]      FIG. 6  is a perspective view, with parts separated, of the distal end of the surgical stapling device; 
           [0021]      FIG. 7  is a perspective view of the assembled and illuminated distal end of the surgical stapling device; 
           [0022]      FIG. 8  is a perspective view of the distal end of the surgical stapling device, with an anvil in the open position, partially illuminated during a stapling stroke; 
           [0023]      FIG. 9  is a perspective view of the distal end of the surgical stapling device, with the anvil in the open position, partially illuminated during a cutting stroke; and 
           [0024]      FIG. 10  is a perspective view of the partially illuminated distal end of the surgical stapling device positioned about a tubular tissue section. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0025]    Embodiments of the presently disclosed surgical fasteners and surgical stapling device will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user. 
         [0026]    Referring to  FIG. 1 , there is disclosed a surgical fastener or surgical staple  10  which includes a coating, coloring or other material to assist in viewing the staple within the body of a patient and to assist in viewing the proper formation of staple  10  into the characteristic “B” fully formed shape. Staple  10  generally includes a backspan  12  having first and second legs  14  and  16 , respectively, extending distally from backspan  12 . First leg  14  terminates in a tissue penetrating tip  18  and second leg  16  terminates in a similar tissue penetrating tip  20 . 
         [0027]    Referring to  FIGS. 1 and 1A , staple  10  includes a core  22  having an active coating  24  applied to core  22 . Core  22  can be formed of a metallic substance such as, for example, stainless steel, titanium, or other deformable/malleable material etc. Active coating  24  may include of materials having molecular fluorescence, molecular phosphorescence, chemiluminescence, etc. which emit visible rays “R” enabling staple  10  to be easily visualized within the body of a patient. By coating core  22  with one or more of these active coatings  24 , staple  10  can be visualized within the body of a patient without reliance on substantially reflected light. For example, some of the above coatings may be activated by ultraviolet light such that they fluorescence or “glow-in-the-dark”. Alternatively, other of the above coatings emit their own sources of light to facilitate visualization of the staple or may emit no visible light such that the staple can be viewed due to substantial contrast against the underlying tissue. 
         [0028]    In the formation of staple  10 , the above described coatings  24  may be applied to core  22  by numerous means well-known in the art. For example, coatings  24  may be applied by the following methods: anodizing, dying, electro-coating, photoluminescent coating, application of nitrides, methyl methacrylate, painting, powder coating, coating with paraffins, oil stains or phosphor coatings, the use of hydroxyapatite, polymers, titanium oxinitrides, zinc sulfides, carbides, etc. It should be noted that, while the listed coatings  24  are fairly specific as disclosed herein, other coatings known in the art to enhance visibility of core  22  are within the contemplated scope of the present disclosure. 
         [0029]    During the specific coating of core  22  with coatings  24 , tissue penetrating tips  18  and  20  may be masked, or otherwise covered to avoid receiving coating  24 . This may be desirable to prevent blunting of tissue penetrating tips  18  and  20  thereby enabling tips  18  and  20  to more cleanly penetrate tissue. 
         [0030]    Referring now to  FIGS. 2 and 2A , and initially with respect to  FIG. 2 , there is disclosed an alternative fastener or coil fastener  30  also configured to be easily visualized within tissue without the aid of reflected light. Coil fastener  30  generally includes a helical coil body  32  having a tissue penetrating tip  34  formed on a distal end  36  of helical coil body  32 . Helical coil body  32  additionally includes a compressed proximal end coil  38  to facilitate driving coil fastener  30  into tissue. 
         [0031]    Referring specifically to  FIG. 2A , and like staple  10  described hereinabove, coil fastener  30  includes a metal core  40  having an active coating  42  applied thereto. Coating  42  also emits visible rays “R” which enable coil faster  30  to be easily visualized within tissue. Coating  42  is formed from, and is applied to core  40 , in manners similar to that described hereinabove with respect to staple  10 . As with tissue penetrating tips  18  and  20  described hereinabove with respect to staple  10 , tissue penetrating tip  34  may be covered during coating to avoid blunting. 
         [0032]    Referring now to  FIGS. 3 and 4 , and initially with respect to  FIG. 3 , the use of a surgical stapling device (not shown) having a distal end  44  portion to apply a fastener, such as, for example, staple  10  to tissue will now be described. Distal end  44  portion includes an elongate tubular member  46  having a staple cartridge  48  mounted thereto. An anvil member  50  is movably attached to elongate tubular member  46  and is movable between an open position substantially spaced apart from staple cartridge  48  to a closed position substantially adjacent staple cartridge  48 . 
         [0033]    Referring to  FIG. 4 , staple cartridge  48  is formed with a knife slot  52  extending longitudinally through staple cartridge  48 . A knife blade  54  is associated with distal end  44  and movable through knife slot  52  so as to sever tissue captured between staple cartridge  48  and anvil member  50 . Staple cartridge  48  further includes multiple rows of staples  10  positioned within staple pockets  56  for application to a tissue, such as tubular tissue section T. In use, distal end  44  is applied to tissue section T such that tissue section T is captured between staple cartridge  48  and anvil member  50  movably mounted on elongate tubular member  46 . Thereafter, the surgical stapler is actuated so as to eject staples  10  from staple pockets  56  within staple cartridge  48 , through tissue section T and into anvil member  50  thereby stapling tissue section T in a known manner. Thereafter, knife blade  54  is advanced through knife slot  52  so as to cut tubular tissue section T between rows of staples  10  now applied to tubular tissue section T. 
         [0034]    Upon removal of distal end  44  of the surgical stapler from about tubular tissue section T, the rows of staples  10 , as well as the proper formation of each individual staple  10 , can be easily visualized in the now free ends of tubular tissue section T by rays “R” emitted from staples  10 . Thus, the proper positioning and formation of staples  10  within a tissue section can be easily visualized without being obscured by reflected light. 
         [0035]    Referring now to  FIG. 5 , there is disclosed a surgical stapler  60  having staple cartridge  62  incorporating one or more light sources to facilitate visualizing the positioning of staple cartridge  62  within the body of a patient. Additionally, as described in more detail hereinbelow, staple cartridge  62  also provides an indication of proper functioning of surgical stapler  60  as it applies staples to tissue and cuts the staple tissue. Surgical stapler  60  generally includes a pistol grip handle  64  having an elongated tubular member  66  extending distally from pistol grip handle  64 . Illuminated staple cartridge  62  is mounted on a distal end  68  of elongate tubular member  66  and includes a transparent cartridge insert  70  housed within a generally U-shaped outer channel  72 . Cartridge insert  70  is provided to transmit optical radiation, in the form of a visible light, to the area surrounding illuminated staple cartridge  62  while U-shaped outer channel  72  shields a portion of the optical radiation. One or more light sources may be associated with surgical stapler  60  to provide a light source for illuminating staple cartridge  62 . 
         [0036]    An anvil member  74  is movably mounted to distal end  68  of elongated tubular member  66 . Anvil member  74  is movable from an open position spaced apart from illuminated staple cartridge  62  to a closed position substantially adjacent to illuminated staple cartridge  62 . A trigger  76  is provided on pistol grip handle  64  to anvil member  74  between the open and closed positions, as well as, to eject staples from illuminated staple cartridge  62  in a manner described in more detail hereinbelow. Finally, a rotation collar  78  is provided to rotate elongate tubular member  66  and orient illuminated staple cartridge  62  and anvil member  74  relative to tissue. 
         [0037]    Referring now to  FIG. 6 , cartridge insert  70  generally includes a body portion  80  having a tapered leading edge  82 . As noted hereinabove, body portion  80  is transparent to optical radiation such that once a light source is applied to body portion  80 , light rays are emitted from a face surface  84 , side surfaces  86  and  88 , as well as from an undersurface  90  of body portion  80 . 
         [0038]    Body portion  80  additionally includes a plurality of staple pockets  92  containing staples  94  for insertion into tissue. Staples  94  may be conventional in manner or may be similar to those described with respect to staple  10  hereinabove. Staple drivers  96  and  98  are provided to extend into corresponding slots in cartridge insert  70  and drive staples  94  out of staple pockets  92  and into tissue. A knife slot  100  extends longitudinally through body portion  80  and face surface  84 . A knife blade  102  is associated with surgical stapler  60  and is movable through knife slot  100  so as to sever tissue captured between illuminated staple cartridge  62  and anvil member  74 . 
         [0039]    As shown, U-shaped outer channel member  72  includes a plurality of windows  104 . Windows  104  are provided for the passage of light rays from side surfaces  86  and  88  of body portion  80 . Windows  104  may additionally be used as mounting structures for corresponding projections formed in body portion  80  (not shown) to facilitate mounting cartridge insert  70  within U-shaped outer channel  72 . 
         [0040]    As noted hereinabove, surgical stapler  60  may be provided with various light sources to facilitate illumination of and through insert  70 . In one embodiment, surgical stapler  60  is provided with a light source  106  positioned within distal end  68  of elongate tubular member  66 . Light source  106  may include one or more lights including LED lights, incandescent lights, electroluminescent lights, light sources utilizing xenon or halogen bulbs, etc. or may be channeled to its desired location by fiber optic filaments or wire, while light source  106  is disclosed as being positioned within distal end  68  of elongate tubular member  66 , light source  106  may alternatively be incorporated directly into cartridge insert  70 . In an alternative embodiment, light source  106  may be an additive infused in cartridge insert  70  having a UV reactive light fluorescence or phosphorescent additive to allow cartridge  70  to be visible. Furthermore, additional means may be utilized to channel a light source via a fiber-optic conduit to cartridge insert  70 . Surfaces of cartridge insert  70  may be polished or coated with a reflective material to amplify and focus the light source forward towards tapered leading edge  82  of body portion  80 . 
         [0041]    While not specifically shown, surgical stapler  60 , and in particular, handle  64  may be provided with various known means of supplying light, and/or electricity, to staple cartridge  62 . Various known means of providing electricity along with switching mechanisms are well-known in the art with respect to electrocaurtery devices and may be incorporated into handle  64 . 
         [0042]    Referring now to  FIG. 7 , and as noted hereinabove, illumination of cartridge insert  70  causes light rays “R” to be emitted from body portion  80 . Specifically, as shown, light rays “R” are emitted from tapered leading edge  82  and face surface  84  so as to allow proper positioning of illuminated staple cartridge  62  within the body of a patient. Further, as body portion  80  projects distally beyond U-shaped outer channel  72 , light rays emanating from undersurface  90  can be used to determine the specific orientation of anvil member  74  and illuminated staple cartridge  62  within the body of a patient. Additionally, light rays “R” emitted from side surfaces  86  and  88  project through windows  104  formed in U-shaped outer channel  72 . The intensity of the light rays “R” emitted through windows  104  may be also utilized to give a general indication of the positioning of staple drivers  96  and  98  as well as the position of knife blade  102  within body portion  80  of cartridge insert  70  and/or the anvil member  74 . 
         [0043]    Referring now to  FIGS. 8 and 9 , movement of staple drivers  96  and  98  as well as movement of knife blade  102  within body portion  80  of cartridge insert  70  blocks internal transmission of a portion of the light provided to cartridge insert  70  by light source  106 . With specific reference to  FIG. 8 , as staple driver  96  moves distally within body portion  80  to eject staples  94  out of staple pockets  92 , staple driver  96  blocks the substantial amount of light internal to body portion  80  thereby greatly diminishing or eliminating the amount of light projected from windows  104  in U-shaped outer channel  72 . During use, the surgeon may take advantage of this feature by noting how many windows  104  adjacent the proximal end of illuminated staple cartridge  62  are not emitting light thereby giving an indication of the position of staple driver  96  and thus an indication of which staples  94  have been actually fired into tissue. 
         [0044]    As shown in  FIG. 9 , as knife blade  102  is advanced within knife slot  100  formed within body portion  80  a specific amount of light from one side of body portion  80  is prevented from being transmitted to the opposed side of body portion  80  by the presence of knife blade  102 . This results in a reduced or diminished amount of light rays “R 1 ” projecting out of windows  104  in U-shaped outer channel  72 . Thus, the position of knife blade  104  within illuminated staple cartridge  62  can be determined during use by the surgeon to assure that a subject tissue section has been completely cut. 
         [0045]    Referring now to  FIG. 10 , in situations where the subject tissue section, such as, for example tissue section T is obscured, i.e., is not completely visible to the surgeon, illuminated staple cartridge  62  may be used in a manner to identify the location of tissue section T and/or assure that tissue section T has been properly grasped between illuminated staple cartridge  62  and anvil member  74 . For example, as shown, when viewed slightly from above, tissue section T obscures light rays emitted from most of windows  104  while allowing light rays to be visible off of tapered leading edge  82  and a distal most window  104 . 
         [0046]    Thus, in this manner it can be seen that staple cartridge  62  can be utilized to both indicate the positioning of the distal end of the surgical stapler within the body of a patient as well as given indication of the relative positions of the staple drivers and knife blade within staple cartridge  62  itself. 
         [0047]    It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the above disclosure may relate to fasteners other than the disclosed conventional staple and helical coil fasteners such as, for example, surgical clips, two-part fasteners, etc. Further, while the above disclosure is given with regard to illuminating a staple cartridge and a surgical stapling device, the present disclosure may find equal utility when incorporated into a surgical instrument having a pair of jaws by illuminating one or both of the jaws to facilitate visualization of the orientation of the surgical instrument within a patient. Additionally, and as noted hereinabove, the disclosed insert within the illuminated staple cartridge and/or anvil may be completely transparent or may include specific zones or regions of transparency so as to facilitate visualization by an operator. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.