Coated surgical staples and an illuminated staple cartridge for a surgical stapling instrument

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.

BACKGROUND

1. Technical Field

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's position in tissue and positioning of the internal components of the staple cartridge.

2. Background of Related Art

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.

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.

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.

Thus, there is a need for a surgical stapling device having a distal end which can be more visible within the patient'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

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.

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.

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.

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.

DETAILED DESCRIPTION OF EMBODIMENTS

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.

Referring toFIG. 1, there is disclosed a surgical fastener or surgical staple10which 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 staple10into the characteristic “B” fully formed shape. Staple10generally includes a backspan12having first and second legs14and16, respectively, extending distally from backspan12. First leg14terminates in a tissue penetrating tip18and second leg16terminates in a similar tissue penetrating tip20.

Referring toFIGS. 1 and 1A, staple10includes a core22having an active coating24applied to core22. Core22can be formed of a metallic substance such as, for example, stainless steel, titanium, or other deformable/malleable material etc. Active coating24may include of materials having molecular fluorescence, molecular phosphorescence, chemiluminescence, etc. which emit visible rays “R” enabling staple10to be easily visualized within the body of a patient. By coating core22with one or more of these active coatings24, staple10can 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.

In the formation of staple10, the above described coatings24may be applied to core22by numerous means well-known in the art. For example, coatings24may 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 coatings24are fairly specific as disclosed herein, other coatings known in the art to enhance visibility of core22are within the contemplated scope of the present disclosure.

During the specific coating of core22with coatings24, tissue penetrating tips18and20may be masked, or otherwise covered to avoid receiving coating24. This may be desirable to prevent blunting of tissue penetrating tips18and20thereby enabling tips18and20to more cleanly penetrate tissue.

Referring now toFIGS. 2 and 2A, and initially with respect toFIG. 2, there is disclosed an alternative fastener or coil fastener30also configured to be easily visualized within tissue without the aid of reflected light. Coil fastener30generally includes a helical coil body32having a tissue penetrating tip34formed on a distal end36of helical coil body32. Helical coil body32additionally includes a compressed proximal end coil38to facilitate driving coil fastener30into tissue.

Referring specifically toFIG. 2A, and like staple10described hereinabove, coil fastener30includes a metal core40having an active coating42applied thereto. Coating42also emits visible rays “R” which enable coil faster30to be easily visualized within tissue. Coating42is formed from, and is applied to core40, in manners similar to that described hereinabove with respect to staple10. As with tissue penetrating tips18and20described hereinabove with respect to staple10, tissue penetrating tip34may be covered during coating to avoid blunting.

Referring now toFIGS. 3 and 4, and initially with respect toFIG. 3, the use of a surgical stapling device (not shown) having a distal end44portion to apply a fastener, such as, for example, staple10to tissue will now be described. Distal end44portion includes an elongate tubular member46having a staple cartridge48mounted thereto. An anvil member50is movably attached to elongate tubular member46and is movable between an open position substantially spaced apart from staple cartridge48to a closed position substantially adjacent staple cartridge48.

Referring toFIG. 4, staple cartridge48is formed with a knife slot52extending longitudinally through staple cartridge48. A knife blade54is associated with distal end44and movable through knife slot52so as to sever tissue captured between staple cartridge48and anvil member50. Staple cartridge48further includes multiple rows of staples10positioned within staple pockets56for application to a tissue, such as tubular tissue section T. In use, distal end44is applied to tissue section T such that tissue section T is captured between staple cartridge48and anvil member50movably mounted on elongate tubular member46. Thereafter, the surgical stapler is actuated so as to eject staples10from staple pockets56within staple cartridge48, through tissue section T and into anvil member50thereby stapling tissue section T in a known manner. Thereafter, knife blade54is advanced through knife slot52so as to cut tubular tissue section T between rows of staples10now applied to tubular tissue section T.

Upon removal of distal end44of the surgical stapler from about tubular tissue section T, the rows of staples10, as well as the proper formation of each individual staple10, can be easily visualized in the now free ends of tubular tissue section T by rays “R” emitted from staples10. Thus, the proper positioning and formation of staples10within a tissue section can be easily visualized without being obscured by reflected light.

Referring now toFIG. 5, there is disclosed a surgical stapler60having staple cartridge62incorporating one or more light sources to facilitate visualizing the positioning of staple cartridge62within the body of a patient. Additionally, as described in more detail hereinbelow, staple cartridge62also provides an indication of proper functioning of surgical stapler60as it applies staples to tissue and cuts the staple tissue. Surgical stapler60generally includes a pistol grip handle64having an elongated tubular member66extending distally from pistol grip handle64. Illuminated staple cartridge62is mounted on a distal end68of elongate tubular member66and includes a transparent cartridge insert70housed within a generally U-shaped outer channel72. Cartridge insert70is provided to transmit optical radiation, in the form of a visible light, to the area surrounding illuminated staple cartridge62while U-shaped outer channel72shields a portion of the optical radiation. One or more light sources may be associated with surgical stapler60to provide a light source for illuminating staple cartridge62.

An anvil member74is movably mounted to distal end68of elongated tubular member66. Anvil member74is movable from an open position spaced apart from illuminated staple cartridge62to a closed position substantially adjacent to illuminated staple cartridge62. A trigger76is provided on pistol grip handle64to anvil member74between the open and closed positions, as well as, to eject staples from illuminated staple cartridge62in a manner described in more detail hereinbelow. Finally, a rotation collar78is provided to rotate elongate tubular member66and orient illuminated staple cartridge62and anvil member74relative to tissue.

Referring now toFIG. 6, cartridge insert70generally includes a body portion80having a tapered leading edge82. As noted hereinabove, body portion80is transparent to optical radiation such that once a light source is applied to body portion80, light rays are emitted from a face surface84, side surfaces86and88, as well as from an undersurface90of body portion80.

Body portion80additionally includes a plurality of staple pockets92containing staples94for insertion into tissue. Staples94may be conventional in manner or may be similar to those described with respect to staple10hereinabove. Staple drivers96and98are provided to extend into corresponding slots in cartridge insert70and drive staples94out of staple pockets92and into tissue. A knife slot100extends longitudinally through body portion80and face surface84. A knife blade102is associated with surgical stapler60and is movable through knife slot100so as to sever tissue captured between illuminated staple cartridge62and anvil member74.

As shown, U-shaped outer channel member72includes a plurality of windows104. Windows104are provided for the passage of light rays from side surfaces86and88of body portion80. Windows104may additionally be used as mounting structures for corresponding projections formed in body portion80(not shown) to facilitate mounting cartridge insert70within U-shaped outer channel72.

As noted hereinabove, surgical stapler60may be provided with various light sources to facilitate illumination of and through insert70. In one embodiment, surgical stapler60is provided with a light source106positioned within distal end68of elongate tubular member66. Light source106may 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 source106is disclosed as being positioned within distal end68of elongate tubular member66, light source106may alternatively be incorporated directly into cartridge insert70. In an alternative embodiment, light source106may be an additive infused in cartridge insert70having a UV reactive light fluorescence or phosphorescent additive to allow cartridge70to be visible. Furthermore, additional means may be utilized to channel a light source via a fiber-optic conduit to cartridge insert70. Surfaces of cartridge insert70may be polished or coated with a reflective material to amplify and focus the light source forward towards tapered leading edge82of body portion80.

While not specifically shown, surgical stapler60, and in particular, handle64may be provided with various known means of supplying light, and/or electricity, to staple cartridge62. 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 handle64.

Referring now toFIG. 7, and as noted hereinabove, illumination of cartridge insert70causes light rays “R” to be emitted from body portion80. Specifically, as shown, light rays “R” are emitted from tapered leading edge82and face surface84so as to allow proper positioning of illuminated staple cartridge62within the body of a patient. Further, as body portion80projects distally beyond U-shaped outer channel72, light rays emanating from undersurface90can be used to determine the specific orientation of anvil member74and illuminated staple cartridge62within the body of a patient. Additionally, light rays “R” emitted from side surfaces86and88project through windows104formed in U-shaped outer channel72. The intensity of the light rays “R” emitted through windows104may be also utilized to give a general indication of the positioning of staple drivers96and98as well as the position of knife blade102within body portion80of cartridge insert70and/or the anvil member74.

Referring now toFIGS. 8 and 9, movement of staple drivers96and98as well as movement of knife blade102within body portion80of cartridge insert70blocks internal transmission of a portion of the light provided to cartridge insert70by light source106. With specific reference toFIG. 8, as staple driver96moves distally within body portion80to eject staples94out of staple pockets92, staple driver96blocks the substantial amount of light internal to body portion80thereby greatly diminishing or eliminating the amount of light projected from windows104in U-shaped outer channel72. During use, the surgeon may take advantage of this feature by noting how many windows104adjacent the proximal end of illuminated staple cartridge62are not emitting light thereby giving an indication of the position of staple driver96and thus an indication of which staples94have been actually fired into tissue.

As shown inFIG. 9, as knife blade102is advanced within knife slot100formed within body portion80a specific amount of light from one side of body portion80is prevented from being transmitted to the opposed side of body portion80by the presence of knife blade102. This results in a reduced or diminished amount of light rays “R1” projecting out of windows104in U-shaped outer channel72. Thus, the position of knife blade104within illuminated staple cartridge62can be determined during use by the surgeon to assure that a subject tissue section has been completely cut.

Referring now toFIG. 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 cartridge62may 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 cartridge62and anvil member74. For example, as shown, when viewed slightly from above, tissue section T obscures light rays emitted from most of windows104while allowing light rays to be visible off of tapered leading edge82and a distal most window104.

Thus, in this manner it can be seen that staple cartridge62can 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 cartridge62itself.

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.