Patent Description:
Surgical staples are applied to tissue using surgical stapling instruments to join tissue or tissue segments in a fast and efficient manner in a variety of surgical procedures, e.g., anastomoses procedures.

Typically, a surgical staple includes a backspan and a pair of spaced legs. The legs are driven through tissue and into an anvil assembly of a surgical stapling instrument to deform the staple into a desired configuration, e.g., B-staple, to effect hemostasis. Current surgical staples are particularly sized and suited for tissue of a given thickness range to effect hemostasis. As such, a clinician must choose a staple having an appropriate size for a given tissue thickness range to ensure effective hemostasis. If the tissue thickness is misidentified by the clinician or if the tissue thickness falls near the outer edges of the range for a given staple size, the likelihood of ineffective hemostasis is increased.

<CIT> discloses a prior art staple cartridge assembly. <CIT> and <CIT> disclose prior art staples comprising a looped member in a backspan. <CIT> discloses a staple having an expandable backspan and a pair of spaced legs. The expandable backspan is configured to expand or deform to accommodate tissues of varying thicknesses. In one embodiment, the backspan is non-linear and defines a recess. In another embodiment, the backspan includes a deformable pad or spacer. The amount of deformation of the backspan is proportional to the thickness of the tissue, i.e., the greater the thickness of tissue, the greater the deformation of the backspan.

Accordingly, a continuing need exists in the suturing arts for a surgical staple that is capable of accommodating a greater range of tissue thicknesses to provide the clinician greater flexibility when performing a variety of surgical procedures.

The present disclosure provides in one aspect a surgical staple including a body having a first leg, a second leg, and a backspan. The first and second legs each have a first end portion and a second end portion. The backspan has a first portion, a second portion, and a third portion. The first portion of the backspan includes a looped member having a first end portion and a second end portion. The second portion of the backspan extends between the first end portion of the first leg and the first end portion of the looped member. The third portion of the backspan extends between the first end portion of the second leg and the second end portion of the looped member. The second portion of the backspan and the third portion of the backspan are in substantial lateral contact.

In certain embodiments, the second portion of the backspan extends in a direction parallel to the third portion of the backspan.

In some embodiments, the looped member of the backspan extends transversely between the second portion of the backspan and the third portion of the backspan.

In certain embodiments, the looped member of the backspan defines an axis that extends between a first end portion of the second portion of the backspan and a first end portion of the third portion of the backspan.

In some embodiments, the second portion of the backspan defines a first axis and the third portion of the backspan defines a second axis, wherein the first axis of the second portion is laterally offset from the second axis of the third portion to define an offset distance between the first axis of the second portion and the second axis of the third portion.

In certain embodiments, the looped member of the backspan includes an apex, the second portion of the backspan includes a first mid-portion, and the third portion of the backspan includes a second mid-portion. The apex of the looped member and the first and second mid-portions of the second and third portions of the backspan, define an axis that is perpendicular to the first axis of the second portion and the second axis of the third portion.

In some embodiments, the offset distance between the first axis of the second portion and the second axis of the third portion is equal to a diameter of the body of the surgical staple.

In certain embodiments, the surgical staple includes an unformed configuration and a formed configuration. In the unformed configuration of the surgical staple, the apex of the looped member of the backspan is spaced apart from each of the second portion and the third portion of the backspan a first distance. In the formed configuration of the surgical staple, the apex of the looped member of the backspan is spaced apart from each of the second portion and the third portion of the backspan a second distance that is less than the first distance of the unformed configuration.

In some embodiments, the surgical staple is deformable from the unformed configuration to the formed configuration upon engagement with tissue, wherein in the formed configuration of the surgical staple, the second distance between the apex of the looped member of the backspan and each of the second portion and the third portion of the backspan decreases as a thickness of tissue engaged by the backspan increases.

In certain embodiments, in the formed configuration of the surgical staple, the first leg is positioned on a first lateral side of the looped member and the second leg is positioned on a second lateral side of the looped member opposite the first lateral side of the looped member.

The present disclosure provides in another aspect a surgical staple including a body having a first leg, a second leg, and a backspan. The first and second legs each have a first end portion and a second end portion. The backspan has a first portion, a second portion, and a third portion. The first portion of the backspan has a looped member including a first end portion and a second end portion. The second portion of the backspan extends longitudinally between the first end portion of the first leg and the first end portion of the looped member. The third portion of the backspan extends longitudinally between the first end portion of the second leg and the second end portion of the looped member. The second portion of the backspan is positioned in close alignment with the third portion of the backspan.

In some embodiments, the second portion of the backspan extends in a direction parallel to the third portion of the backspan.

In certain embodiments, the looped member of the backspan includes an apex, the second portion of the backspan includes a first mid-portion, and the third portion of the backspan includes a second mid-portion. The apex of the looped member and the first and second mid-portions of the second and third portions of the backspan defining an axis that is parallel to at least one of the first leg and the second leg.

In some embodiments, the surgical staple is deformable from an unformed configuration to a formed configuration. In the formed configuration of the surgical staple, the second end portion of the first leg is positioned on a first lateral side of the looped member of the backspan and the second end portion of the second leg is positioned on a second lateral side of the looped member of the backspan, opposite the first lateral side of the looped member of the backspan.

In certain embodiments, the second portion of the backspan and the third portion of the backspan are in lateral contact.

The present disclosure provides in yet another aspect a staple cartridge assembly for use with a surgical stapling instrument including a plurality of surgical staples, a staple cartridge, and a plurality of pushers. The plurality of surgical staples are in a spaced relation to each other and each includes a first leg, a second leg, and a backspan. The first and second legs each have a first end portion and a second end portion. The backspan has a first portion, a second portion, and a third portion. The first portion of the backspan includes a looped member having a first end portion and a second end portion. The second portion of the backspan extends between the first end portion of the first leg and the first end portion of the looped member. The third portion of the backspan extends between the first end portion of the second leg and the second end portion of the looped member. The staple cartridge has a plurality of staple pockets disposed in rows and skewingly positioned relative to a longitudinal axis of the staple cartridge. Each of the plurality of staple pockets is configured to receive at least one of the plurality of surgical staples such that the first leg and the second leg of each of the plurality of surgical staples is longitudinally aligned relative to the first leg and the second leg of each of the other plurality of surgical staples. Each of the plurality of pushers is associated with a respective one of the plurality of staple pockets. Each of the plurality of pushers is configured to advance one of the plurality of surgical staples from the respective one of the plurality of staple pockets.

In some embodiments, each of the plurality of staple pockets includes a contour having a first segment shaped and dimensioned to receive the first leg of the surgical staple, a second segment shaped and dimensioned to receive the second leg of the surgical staple, and an intermediate segment shaped and dimensioned to receive the backspan of the surgical staple. The contour of each of the plurality of staple pockets is skewingly positioned relative to the longitudinal axis of the staple cartridge.

In certain embodiments, each of the plurality of pushers includes a staple seat configured to releasably receive a respective backspan of each of the plurality of surgical staples, the staple seat being skewingly positioned relative to a longitudinal axis of each of the plurality of pushers. The staple seat of each of the plurality of pushers is adapted to align each of the plurality of surgical staples with each of the plurality of staple pockets of the staple cartridge.

In some embodiments, the staple seat of each of the plurality of pushers includes a first wall projecting from a first portion of the staple seat, and a second wall projecting from a second portion of the staple seat, the first wall and the second wall defining a skewed channel extending between the first portion of the staple seat and the second portion of the staple seat, the skewed channel being skewingly positioned relative to the longitudinal axis of the pusher.

In certain embodiments, the skewed channel of the staple seat of each of the plurality of pushers is adapted to releasably receive the respective backspan of each of the plurality of surgical staples such that each of the plurality of surgical staples are skewingly positioned on the staple seat of each of the plurality of pushers relative to the longitudinal axis of each of the plurality of pushers.

In some embodiments, when each of the plurality of surgical staples are positioned on a respective staple seat of each of the plurality of pushers, the first wall of respective staple seat is configured to engage the second portion of the respective backspan of each of the plurality of surgical staples and the second wall of the respective staple seat is configured to engage the third portion of the respective backspan of each of the plurality of surgical staples to releasably receive the respective backspan of each of the plurality of surgical staples.

Various embodiments of the presently disclosed expandable backspan staples and cartridges for supporting the staples are disclosed herein with reference to the drawings, wherein:.

Embodiments of the presently disclosed surgical staple will now be described in detail with reference to the drawings wherein like references numerals identify similar or identical elements. In the drawings, and in the following description, the term "proximal" should be understood to refer to that portion or end of the instrument that is closest to a user during proper use, while the term "distal" should be understood to refer to that portion or end of the instrument that is furthest from a user during proper use, as is traditional and conventional in the art.

Referring initially to <FIG>, an exemplary embodiment of the present disclosure is shown generally as a surgical staple <NUM>. The surgical staple <NUM> includes a body <NUM> having a backspan <NUM>, a first leg <NUM>, and a second leg <NUM>. The surgical staple <NUM> has an unformed configuration, as shown in <FIG>, wherein the first leg <NUM> and the second leg <NUM> are parallel, or substantially parallel, to one another and spaced a distance from one another. Alternatively, in the unformed configuration, the first and second legs <NUM>, <NUM> can diverge slightly or converge slightly, etc. in relation to each other.

Each of the first and second legs <NUM>, <NUM> includes a first end portion 14a, 16a, respectively, and a second end portion 14b, 16b, respectively. Each of the second end portions 14b, 16b of the first and second legs <NUM>, <NUM> includes a tissue-penetrating tip 14c, 16c. In one embodiment, each of the tissue-penetrating tips 14c, 16c of the respective first and second legs <NUM>, <NUM> of the surgical staple <NUM> can be formed with beveled or tapered end to facilitate penetration of the first and second legs <NUM>, <NUM> into tissue "T" (see <FIG>). Alternately, the tissue penetrating tips 14c, 16c of the respective first and second legs <NUM>, <NUM> of the surgical staple <NUM> need not be tapered, can be tapered in a different direction, or can define a conical or flat surface.

With continued reference to <FIG>, the backspan <NUM> includes a first portion 12a having a looped member <NUM>, a second portion <NUM> that is substantially linear and extends between the first end portion 14a of the first leg <NUM> and a first end portion 18a of the looped member <NUM>, and a third portion <NUM> that is substantially linear and extends between the first end portion 16a of the second leg <NUM> and a second end portion 18b of the looped member <NUM>. The looped member <NUM> of the backspan <NUM> includes an arcuate portion <NUM> that extends between the second and third portions <NUM>, <NUM> of the backspan <NUM>. In the unformed configuration of the surgical staple <NUM>, the second portion <NUM> of the backspan <NUM> may be substantially parallel to the third portion <NUM> of the backspan <NUM> and in lateral contact or close alignment with the third portion <NUM> of the backspan <NUM>, as illustrated in <FIG>.

In embodiments, the arcuate portion <NUM> of the looped member <NUM> extends transversely between the second portion <NUM> and the third portion <NUM> of the backspan <NUM>. In the unformed configuration of the surgical staple <NUM>, the second portion <NUM> of the backspan <NUM> defines an axis "X1-X1" and the third portion <NUM> of the backspan <NUM> defines an axis "X2-X2". The axis "X1-X1" of the second portion <NUM> and the axis "X2-X2" of the third portion <NUM> may be laterally offset from each other an offset distance "OD". It is envisioned that the offset distance "OD" between the axis "X1-X1" of the second portion <NUM> and the axis "X2-X2" of the third portion <NUM> may be substantially equal to a diameter "BD" of the body <NUM> of the surgical staple <NUM> such that the second portion <NUM> and the third portion <NUM> are closely positioned or in contact with each other.

The arcuate portion <NUM> of the looped member <NUM> defines an axis "X3-X3" that extends between a first end portion 20a of the second portion <NUM> of the backspan <NUM> and a first end portion 22a of the third end portion <NUM> of the backspan <NUM>. In embodiments, the looped member <NUM> and the second and third portions <NUM>, <NUM> may define an enclosed opening <NUM> which may have a circular or oval configuration. It is envisioned that the arcuate portion <NUM> of the looped member <NUM> of the backspan <NUM> can be formed having any desired radius of curvature to suit a particular need, surgical procedure, or range of tissue thicknesses (as will be discussed below). It is also envisioned that the opening <NUM> defined by the backspan <NUM> need not be circular or oval but rather may have other configurations, such as, for example, U-shaped, trapezoidal, rectangular, etc. The backspan can have other shapes, such as round, rectilinear, etc., and the member <NUM> can be straight, angled or curved. Further, in embodiments, the backspan <NUM> may include more than one looped member <NUM>.

The body <NUM> of the surgical staple <NUM> can have a circular cross-section throughout its length. Alternatively, it is envisioned that the body <NUM> of the surgical staple <NUM> may have a variety of different cross-sectional shapes including rectangular, oval, square, triangular, trapezoidal, etc. It is also envisioned that the backspan <NUM> of the surgical staple <NUM> and the first and second legs <NUM>, <NUM> of the surgical staple <NUM> may have different cross-sectional shapes. For example, in one embodiment, the backspan <NUM> of the surgical staple <NUM> can have a rectangular cross-sectional shape and the first and second legs <NUM>, <NUM> of the surgical staple <NUM> can have an oval cross-sectional shape.

The surgical staple <NUM> may be fabricated from a formable material, such as, for example, titanium, stainless steel or a variety of different bio-compatible polymers. In this manner, the surgical staple <NUM> may be introduced over tissue while in an unformed configuration, and then deformed or fastened onto the tissue to secure the surgical staple <NUM> to the tissue. It is contemplated that the surgical staple <NUM> may be fabricated from any nondegradable, biocompatible material known by those having skill in the art.

Referring now to <FIG>, in some embodiments, the first and second legs <NUM>, <NUM> of the surgical staple <NUM> are deformed against an anvil assembly <NUM> (see <FIG>) of a surgical stapling instrument <NUM> into a substantially B-shaped staple configuration. Since the first and second legs <NUM>, <NUM> of the surgical staple <NUM> extend from the second and third portions <NUM>, <NUM> of the backspan <NUM>, respectively, and the axis "X1-X1" of the second portion <NUM> and the axis "X2-X2" of the third portion <NUM> are laterally offset from each other by the offset distance "OD," which is substantially equal to the diameter "BD" of the body <NUM> of the surgical staple <NUM>, it is envisioned that in the formed configuration of the surgical staple <NUM>, the first leg <NUM> of the surgical staple <NUM> is positioned on a first lateral side 24a of the arcuate portion <NUM> of the looped member <NUM> and the second leg <NUM> is positioned on a second, opposite lateral side 24b of the arcuate portion <NUM> of the looped member <NUM> (see <FIG>, <FIG>).

In the formed configuration, the arcuate portion <NUM> of the looped member <NUM> of the backspan <NUM> is configured to deform relative to the second and third portions <NUM>, <NUM> of the backspan <NUM>, wherein the first and second transverse portions <NUM>, <NUM> of the looped member <NUM> of the backspan <NUM> remain substantially linear. Specifically, the deformation of the backspan <NUM> of the surgical staple <NUM> is dependent upon a thickness, e.g., "T1," "T2," "T3," etc., of the tissue "T" to be fastened. Initially, in the unformed configuration of the surgical staple <NUM>, the looped member <NUM> of the backspan <NUM> includes an uncompressed distance "D1" between an apex 24c of the arcuate portion <NUM> of the looped member <NUM> and the second and third portions <NUM>, <NUM> of the backspan <NUM>, as illustrated in <FIG>. In some embodiments, it is contemplated that the apex 24c of the arcuate portion <NUM> and a mid-portion "M1" (see <FIG>) of the second portion <NUM> of the backspan <NUM> and a mid-portion "M2" (see <FIG>) of the third portion <NUM> of the backspan <NUM> defines an axis "X4-X4" that is substantially parallel to at least one of the first and second legs <NUM>, <NUM> of the surgical staple <NUM> and/or substantially perpendicular to the axis "X1-X1" of the second portion <NUM> of the backspan <NUM> and the axis "X2-X2" of the third portion <NUM> of the backspan <NUM>. Upon engagement with the tissue "T," the looped member <NUM> of the backspan <NUM> is compressed between the tissue "T" and anvil assembly <NUM> (see <FIG>) of a surgical stapling instrument <NUM> such that, the looped member <NUM> of the backspan <NUM> defines a compressed distance "D2" between the apex 24c of the arcuate portion <NUM> of the looped member <NUM> and the second and third portions <NUM>, <NUM> of the backspan <NUM>, as illustrated in <FIG>. As the looped member <NUM> contacts tissue "T" positioned between the first and second legs <NUM> and the looped member <NUM> as the staples <NUM> are deformed, the distance ""D2" decreases an amount that is directly related to the thickness of the tissue "T". More specifically, as the thickness of the tissue increases, the force applied to the looped member <NUM> by the tissue "T" positioned between the first and second legs <NUM>, <NUM> and the looped member <NUM> of the staples <NUM> as the staples <NUM> are deformed increases, to increase the amount of deformation of the looped member <NUM>.

<FIG> illustrates a staple <NUM> as the staple <NUM> is formed in relatively thin tissue "T" having a first thickness "T1". As the staple <NUM> is deformed about relatively thin tissue "T" having a thickness "T1", the tissue "T" is compressed between the first and second legs <NUM>, <NUM> and the looped member <NUM> of the staples <NUM>. As the first and second legs <NUM>, <NUM> of the staple <NUM> are deformed into a B-configuration against the anvil assembly <NUM> of the surgical stapling instrument <NUM> (<FIG>), the first and second legs <NUM>, <NUM> push tissue "T" towards and against the looped member <NUM> of the backspan <NUM>. Because the anvil assembly <NUM> is disposed a fixed distance from the cartridge assembly <NUM> when the stapling instrument is fired (as described in detail below), all of the tissue "T" must fit between the first and second legs <NUM>, <NUM> and the looped member <NUM> of the backspan <NUM>. Thus, where the tissue "T" is relatively thin, the tissue does not apply any substantial forces onto the looped member <NUM> as the first and second legs <NUM>, <NUM> are deformed and little or no deformation to the looped member <NUM> occurs. Thus, the distance "D2" between the apex 24c of the arcuate portion <NUM> of the looped member <NUM> and the second and third portions <NUM>, <NUM> of the surgical staples <NUM> remains substantially unchanged or only decreases slightly. Referring to <FIG>, where the tissue "T" has a moderate thickness of "T2", the tissue "T" requires more space between the first and second legs <NUM>, <NUM> and the looped member <NUM> of the backspan <NUM>. Thus, as the first and second legs <NUM>, <NUM> are deformed against the anvil assembly <NUM> and the tissue "T" is pushed towards the looped member <NUM> of the backspan <NUM>, a greater force is applied to the looped member <NUM> to cause greater amount of deformation of the looped member <NUM> of the backspan <NUM>. Thus, the distance "D2" between the apex 24c of the arcuate portion <NUM> of the looped member <NUM> and the second and third portions <NUM>, <NUM> of the backspan <NUM> of the surgical staple <NUM> decreases a moderate amount. Similarly, where the tissue "T" has a large thickness of "T3" as shown in <FIG>, the tissue "T" requires even more space between the first and second legs <NUM>, <NUM> and the looped member <NUM> of the backspan <NUM> as the staple <NUM> is deformed. Thus, as the first and second legs <NUM>, <NUM> are deformed against the anvil assembly <NUM> and the tissue "T" is pushed towards the looped member <NUM> of the backspan <NUM>, an even greater force is applied to the looped member <NUM> to cause a greater amount of deformation of the looped member <NUM> of the backspan <NUM> to further reduce the distance D2" between the apex 24c of the arcuate portion <NUM> of the looped member <NUM> and the second and third portions <NUM>, <NUM> of the backspan <NUM> of the surgical staple <NUM>.

As illustrated in <FIG>, it is envisioned that the arcuate portion <NUM> of the looped member <NUM> of the backspan <NUM> becomes progressively more linear as the thickness of the tissue "T" increases. The ability of the backspan <NUM> of the surgical staple <NUM> to deform in accordance with the relative thickness of the tissue "T" facilitates the use of the presently disclosed staples with tissue having a wider range of thicknesses while providing effective hemostasis.

In order to place the presently disclosed surgical staple <NUM> in the tissue "T," a surgical apparatus in the form of the surgical stapling instrument <NUM> is provided, as illustrated in <FIG>. The surgical stapling instrument <NUM> is approximated and fired similarly to, and in accordance with other known surgical stapling instrument, for example, the surgical stapling instrument disclosed in<CIT>.

As illustrated in <FIG>, the surgical stapling instrument <NUM> generally includes a handle assembly <NUM> with a movable handle 1003a and a stationary handle 1003b, an elongated shaft <NUM> extending distally from the handle assembly <NUM>, and a loading unit <NUM> that is coupled to a distal portion of the elongated shaft <NUM>. In any of the embodiments disclosed herein, the handle assembly can include, or be attached to, one or more motors, or could be configured to work with a surgical robotic system.

With reference to <FIG>, the loading unit <NUM> of the surgical stapling instrument <NUM> includes a tool assembly <NUM> having a staple cartridge assembly <NUM> housing a plurality of surgical staples <NUM> (see <FIG>) and an anvil assembly <NUM> movably secured in relation to the staple cartridge assembly <NUM> such that the tool assembly <NUM> is movable between an open configuration (see <FIG>) where the staple cartridge assembly <NUM> is spaced apart from the anvil assembly <NUM>, and a clamped configuration (see <FIG>) where the staple cartridge assembly <NUM> and the anvil assembly <NUM> are approximated. Alternately, the cartridge assembly <NUM> can be movably supported in relation to the anvil assembly <NUM>.

Turning now to <FIG>, the staple cartridge assembly <NUM> includes a carrier <NUM> having an elongated support channel <NUM>. The elongated support channel <NUM> is dimensioned and configured to receive a staple cartridge <NUM>. The staple cartridge assembly <NUM> includes a pair of elastic or resilient members 1316a, 1316b that are configured and dimensioned to apply and maintain a constant compressive force to the tissue "T" positioned between the staple cartridge assembly <NUM> and the anvil assembly <NUM> (see <FIG>) of the tool assembly <NUM>. In embodiments, the pair of elastic or resilient members 1316a, 1316b may be configured as two substantially parallel, elongate members that are positioned between the staple cartridge <NUM> and a pair of shoulders 1318a, 1318b formed on the carrier <NUM>, respectively. The pair of elastic members 1316a, 1316b may be attached to, or otherwise disposed on, the pair of shoulders 1318a, 1318b of the carrier <NUM>, and may be fixedly or releasably attached thereto in alternative embodiments. The pair of elastic members 1316a, 1316b is configured to compress to accommodate tissues of different thicknesses between the cartridge assembly <NUM> and the anvil assembly <NUM>. For a more detailed description of the construction and operation of an example of the pair of elastic members 1316a, 1316b, reference may be made to <CIT>.

The staple cartridge <NUM> of the staple cartridge assembly <NUM> includes a plurality of staple pockets <NUM> that are arranged in rows. The plurality of staple pockets <NUM> are dimensioned for receiving the plurality surgical staples <NUM> and a plurality of pushers <NUM>, as will be detailed below. The staple cartridge assembly <NUM> includes an actuation sled <NUM> movably supported with in the elongated support channel <NUM> of the carrier <NUM>. During operation, the actuation sled <NUM> is configured to advance along the elongated support channel <NUM> of the carrier <NUM> to sequentially contact the plurality of pushers <NUM>, such that the plurality of pushers <NUM> are displaced within the plurality of staple pockets <NUM> to eject the plurality of surgical staples <NUM> from the plurality of staple pockets <NUM> towards the anvil assembly <NUM>.

As detailed above with reference to <FIG>, the axis "X1-X1" of the second portion <NUM> of the backspan <NUM> and the axis "X2-X2" of the third portion <NUM> of the backspan <NUM>" are laterally offset from each other by the offset distance "OD". In order to compensate for the laterally offset orientation of the backspan12 of the surgical staple <NUM> and ensure that the first and second legs <NUM>, <NUM> of each of the plurality of surgical staples <NUM> are longitudinally aligned relative to the other plurality of surgical staples <NUM> in a corresponding row of surgical staples <NUM>, the plurality of staple pockets <NUM> of the staple cartridge <NUM> and a plurality of staple seats <NUM> of the plurality of pushers <NUM> are dimensioned and shaped as detailed below.

Specifically, with reference to <FIG>, each of the plurality of staple pockets <NUM> of the staple cartridge <NUM> includes a contour "C" that corresponds to the orientation of the surgical staple <NUM> as shown in the top view of the surgical staple <NUM> in <FIG>. The contour "C" of the staple pocket <NUM> of the staple cartridge <NUM> includes a first portion "C1" that is shaped and dimensioned to receive the first leg <NUM> of the surgical staple <NUM>, a second portion "C2" that is shaped and dimensioned to receive the second leg <NUM> of the surgical staple <NUM>, and an intermediate portion "C3" positioned between the first portion "C1" and the second portion "C2" that is shaped and dimensioned to receive the backspan <NUM> of the surgical staple <NUM>. The plurality of staple pockets <NUM> of the staple cartridge <NUM> are skewingly positioned relative to a longitudinal axis "A-A" of the staple cartridge <NUM> such that the first and second legs <NUM>, <NUM> of each of the plurality of surgical staples <NUM> are longitudinally aligned relative to the other plurality of surgical staples <NUM> in the corresponding row of surgical staples <NUM>.

With reference to <FIG>, each of the plurality of staple seats <NUM> of the plurality of pushers <NUM> is adapted for releasably receiving the backspan <NUM> of the surgical staple <NUM>. The staple seat <NUM> of the pusher <NUM> is skewingly positioned relative to a longitudinal axis "B-B" of the pusher <NUM>, as illustrated in <FIG>. It is envisioned that the skewed configuration of the staple seat <NUM> of the pusher <NUM> is adapted to align the surgical staple <NUM> with the skewingly positioned staple pocket <NUM> of the staple cartridge <NUM>, as the surgical staple <NUM> is ejected through the staple pocket <NUM> towards the anvil assembly <NUM>, as illustrated in <FIG>, <FIG>. Specifically, the staple seat <NUM> of the pusher <NUM> includes a first wall 1326a projecting from a first portion 1326b of the staple seat <NUM> and towards the staple pocket <NUM> of the staple cartridge <NUM>, and a second wall 1326c projecting from a second portion 1326d of the staple seat <NUM> and towards the staple pocket <NUM> of the staple cartridge <NUM>. The first and second walls 1326a, 1326c of the staple seat <NUM> of the pusher <NUM> defines a skewed channel <NUM> extending between the first and second portions 1326b, 1326d of the staple seat <NUM> of the pusher <NUM>. The skewed channel <NUM> of the staple seat <NUM> is skewingly positioned relative to the longitudinal axis "B-B" of the pusher <NUM>.

When the surgical staple <NUM> is located on the staple seat <NUM> of the pusher <NUM>, the first wall 1326a of the staple seat <NUM> is configured to engage the second portion <NUM> of the backspan <NUM> and the second wall 1326b of the staple seat <NUM> is configured to engage the third portion <NUM> of the backspan <NUM> to releasably receive the backspan <NUM> of the surgical staple <NUM>. Since the skewed channel <NUM> of the staple seat <NUM> is skewingly positioned relative to the longitudinal axis "B-B" of the pusher <NUM>, it is envisioned that when the surgical staple <NUM> is located on the staple seat <NUM> of the pusher <NUM>, the surgical staple <NUM> is skewingly positioned relative to the longitudinal axis "B-B" of the pusher <NUM>, as illustrated in <FIG>.

Turning now to <FIG>, <FIG>, <FIG>, in embodiments, the plurality of staple pockets <NUM> are arranged in rows on lateral sides of a knife slot <NUM> extending through the staple cartridge <NUM> of the staple cartridge assembly <NUM>. The knife slot <NUM> is configured to accommodate movement of a knife <NUM>, or other such cutting element to sever the tissue "T" (see <FIG>) disposed between the staple cartridge assembly <NUM> and the anvil assembly <NUM>. In embodiments, the knife slot <NUM> may extend along a centerline "CL" of the staple cartridge <NUM> of the staple cartridge assembly <NUM>, as illustrated in <FIG>. Alternatively, the knife slot <NUM> may be laterally offset from the centerline "CL" of the staple cartridge <NUM> of the staple cartridge assembly <NUM>.

With reference to <FIG>, the anvil assembly <NUM> includes a corresponding knife slot <NUM> on a tissue-facing surface <NUM> of the anvil assembly <NUM> that is configured to accommodate movement of the knife <NUM>. In embodiments, the knife <NUM> includes an I-beam configuration such that a top portion 1332a of the knife <NUM> is movably disposed within the knife slot <NUM> of the anvil assembly <NUM> and a bottom portion 1332b of the knife <NUM> is movably disposed within the knife slot <NUM> of the staple cartridge <NUM> of the staple cartridge assembly <NUM>. In any of the embodiments disclosed herein, the knife can have other shapes, or could be part of or attached to the sled.

With continued reference to <FIG>, the knife <NUM> includes a height "H". When the staple cartridge assembly <NUM> and the anvil assembly <NUM> are approximated and the knife <NUM> is translated through the respective knife slots <NUM>, <NUM>, the height "H" of the knife <NUM> provides for a constant distance "D3" between the anvil assembly <NUM> and each of the plurality of staple seats <NUM> of the plurality of pushers <NUM>, regardless of the thickness of the tissue "T" (see <FIG>) disposed between the staple cartridge assembly <NUM> and the anvil assembly <NUM> and regardless of the positioning of the staple cartridge <NUM>. The height "H" of the knife <NUM> also provides for a maximum tissue gap when the knife <NUM> is translated through the respective knife slots <NUM>, <NUM>.

Referring now to <FIG>, in operation, the surgical stapling instrument <NUM> is manipulated such that the tissue "T" is disposed between the staple cartridge assembly <NUM> and the anvil assembly <NUM> with the tool assembly <NUM> spaced-apart, in the open configuration (see <FIG>). The staple cartridge assembly <NUM> and the anvil assembly <NUM> are then approximated by actuating the movable handle 1003A of the handle assembly <NUM> to clamp the tissue "T" disposed between the staple cartridge assembly <NUM> and the anvil assembly <NUM> such that a compressive force is applied to the tissue "T".

With the tissue "T" securely clamped between the staple cartridge assembly <NUM> and the anvil assembly <NUM>, the surgical stapling instrument <NUM> is then fired to eject the plurality of surgical staples <NUM> by actuating the movable handle 1003A. Upon firing the surgical stapling instrument <NUM>, the actuation sled <NUM> (<FIG>) advances along the elongated support channel <NUM> of the carrier <NUM> to sequentially contact the plurality of pushers <NUM>, such that the plurality of pushers <NUM> are displaced within the plurality of staple pockets <NUM> to eject the plurality of surgical staples <NUM> from the plurality of staple pockets <NUM> towards the anvil assembly <NUM>.

The plurality of surgical staples <NUM> pass through the plurality of staple pockets <NUM> of the staple cartridge <NUM> (see <FIG>) and through the tissue "T". After passing through the tissue "T," the plurality of surgical staples <NUM> engage the tissue-facing surface <NUM> of the anvil assembly <NUM> and are deformed into the substantially B-staple configuration (see <FIG>). Upon formation within the tissue "T," the plurality of surgical staples <NUM> maintain a compressive force on the tissue "T" to effect hemostasis.

Sequential firing of the surgical staples <NUM> continues until the actuation sled <NUM> is advanced to a distal end of the staple cartridge <NUM>, at which time all of the plurality of surgical staples <NUM> housed the staple cartridge <NUM> will have been ejected. The knife <NUM> may then be translated through the tool assembly <NUM> to form an incision between the rows of stapled tissue "T".

In any of the embodiments disclosed herein, the tool assembly can be incorporated with the elongate portion of the handle assembly. The staple cartridge can be a removable and replaceable assembly, in an instrument with a replaceable loading unit or tool assembly or incorporated tool assembly.

The surgical staples described herein can be utilized in a configuration where the backspan is not intended to be deformed. In certain embodiments, the backspan can be configured to house a material or object, with a deformable backspan or a backspan that is not deformable. The material or object can include medically useful materials such as a hemostat or sealant, pharmaceuticals such as chemotheraphy agents, and even radio-active agents such as brachytherapy particles or seeds. Such materials or objects can be disposed in the opening formed by the looped member or incorporated in a mesh, woven, braided, non-woven material, or a suture, that is disposed in the looped member.

Claim 1:
A staple cartridge assembly (<NUM>) for use with a surgical stapling instrument, the staple cartridge assembly comprising:
a plurality of surgical staples (<NUM>) supported in a spaced relation to each other, each of the plurality of surgical staples including:
a first leg (<NUM>) having a first end portion (14a) and a second end portion (14b);
a second leg (<NUM>) having a first end portion (16a) and a second end portion (16b); and
a backspan (<NUM>) including:
a first portion (12a) having a looped member (<NUM>), the looped member including a first end portion (18a) and a second end portion (18b);
a second portion (<NUM>) extending between the first end portion (14a) of the first leg and the first end portion (18a) of the looped member; and
a third portion (<NUM>) extending between the first end portion (16a) of the second leg and the second end portion (18b) of the looped member;
a staple cartridge (<NUM>) having a plurality of staple pockets (<NUM>) disposed in rows and skewingly positioned relative to a longitudinal axis ("A-A") of the staple cartridge, wherein each of the plurality of staple pockets (<NUM>) is configured to receive at least one of the plurality of surgical staples (<NUM>) such that the first leg (<NUM>) and the second leg (<NUM>) of each of the plurality of surgical staples is longitudinally aligned relative to the first leg and the second leg of each of the other plurality of surgical staples of a same row; and
a plurality of pushers (<NUM>), each of the plurality of pushers associated with a respective one of the plurality of staple pockets (<NUM>) and each of the plurality of pushers configured to advance one of the plurality of surgical staples (<NUM>) from the respective one of the plurality of staple pockets, the staple cartridge assembly (<NUM>) further including a carrier (<NUM>) having an elongated support channel (<NUM>), the elongated support channel (<NUM>) being dimensioned and configured to receive the staple cartridge (<NUM>), characterized by the staple cartridge assembly (<NUM>) further including a pair of elastic or resilient members (1316a, 1316b) that are configured and dimensioned to apply and maintain a constant compressive force to the tissue ("T") positionable between the staple cartridge assembly (<NUM>) and an anvil assembly (<NUM>).