Patent Description:
Surgical stapling devices for stapling tissue during a surgical procedure are well known. Such devices allow a clinician to suture tissue more quickly than traditional suturing techniques to shorten the length of the surgical procedure and minimize patient trauma. During operation of a stapling device, tissue is simultaneously cut and stapled to perform a variety of different surgical procedures. Typically, a surgical stapling device includes a central knife slot and rows of staples positioned on each side of the central knife slot.

During an oncological surgical procedure, in order classify the extent of spread of cancerous tissue, a surgeon resects tissue surrounding cancerous tissue and sends it to pathology for immediate examination. For a pathologist to examine a tissue specimen, the pathologist must remove the staples from the tissue specimen one by one, stain the specimen, and freeze the specimen. The frozen specimen is sectioned and analyzed microscopically to determine if cancer cells are present in the specimen. Typically, examination of the tissue should be done within <NUM> minutes of tissue removal. Most of the <NUM> minutes is spent removing the staples from the tissue. As such, to avoid delay, clinicians sometimes just cut the staple line from the tissue.

The staple line is closest to the cancerous tissue and defines a true margin which should be examined to determine the extent of cancer spread. When tissue is stapled with rows of staples, the tissue along the staple line is compressed by the rows of staples and may not be acceptable for analysis. A close margin for analysis is about <NUM>. In some instances, the staple line has a width of up to <NUM>. As such, it is undesirable to cut the staple line from the tissue to be examined.

A continuing need exists in the art for a surgical stapling device that includes a tool assembly that forms a staple line that minimizes damage to tissue and can be quickly removed from tissue to facilitate pathological examination. <CIT> is a surgical stapling device including a tool assembly having pushers for ejecting staples from a staple cartridge of the stapling device. <CIT> is a surgical fastener for closing a trocar incision.

Certain optional features of the invention are defined in the dependent claims. Aspects of this disclosure are directed to a staple cartridge including a cartridge body, a plurality of first staples, and a plurality of second staples. The cartridge body defines a longitudinal axis, a central knife slot, a plurality of first staple receiving slots, and a plurality of second staple receiving slots. The plurality of first staple receiving slots is aligned in rows on a first side of the central knife slot and the plurality of second staple receiving slots is aligned in a row on a second side of the central knife slot. Each of the plurality of second staple receiving slots has a Y-shaped configuration. Each first staple of the plurality of first staples is received within one of the plurality of first receiving slots. Each second staple of the plurality of second staples is received within one of the plurality of second staple receiving slots and has a Y-shaped configuration.

Other aspects of this disclosure are directed to an anvil that includes an anvil plate. The anvil plate defines a longitudinal axis and has a staple forming surface. The staple forming surface defines a central knife slot, a plurality of first staple forming pockets, and a plurality of second staple forming pockets. The plurality of first staple forming pockets is aligned in rows on a first side of the central knife slot, and the plurality of second staple forming pockets is aligned in a row on a second side of the central knife slot. Each second staple forming pocket of the plurality of second staple forming pockets is aligned in a row on a second side of the central knife slot and has a Y-shape.

Another aspect of the disclosure is directed to a tool assembly that includes a staple cartridge and an anvil. The staple cartridge includes a cartridge body, a plurality of first staples, and a plurality of second staples. The cartridge body defines a longitudinal axis, a first central knife slot, a plurality of first staple receiving slots, and a plurality of second staple receiving slots. The plurality of first staple receiving slots is aligned in rows on a first side of the first central knife slot. The plurality of second staple receiving slots is aligned in a row on a second side of the first central knife slot. Each second staple receiving slot of the plurality of second staple receiving slots has a Y-shaped configuration. Each first staple of the plurality of first staples is received within one first staple receiving slot of the plurality of first receiving slots. Each second staple of the plurality of second staples is received within one second staple receiving slot of the plurality of second staple receiving slots and has a Y-shaped configuration. The anvil includes an anvil plate that defines a longitudinal axis and has a staple forming surface. The staple forming surface defines a second central knife slot, a plurality of first staple forming pockets, and a plurality of second staple forming pockets. The plurality of first staple forming pockets is aligned in rows on a first side of the second central knife slot. The plurality of second staple forming pockets is aligned in a row on a second side of the second central knife slot. Each second staple forming pocket of the plurality of second staple forming pockets is aligned in a row on a second side of the second central knife slot and has a Y-shape.

In aspects of the disclosure, each second staple of the plurality of second staples includes first, second, and third legs.

In some aspects of the disclosure, each second staple of the plurality of second staples includes a first back span that interconnects the first leg to the third leg and a second back span that interconnects the second leg to the third leg.

In certain aspects of the disclosure, each of the first, second, and third legs includes a tapered tip for piercing tissue.

In aspects of the disclosure, the staple cartridge includes a plurality of first pushers and a plurality of second pushers.

In some aspects of the disclosure, each first staple of the plurality of first staples is supported within one first staple receiving slot of the plurality of first staple receiving slots on one first pusher of the plurality of first pushers, and each second staple of the plurality of second staples is supported within one second staple receiving slot of the plurality of second staple receiving slots on one second pusher of the plurality of second pushers.

In certain aspects of the disclosure, each second pusher of the plurality of second pushers is V-shaped.

In aspects of the disclosure, the staple cartridge includes an actuation sled that is movable from a retracted position to an advanced position within the cartridge body into engagement with the plurality of first and second pushers to eject the plurality of first and second staples from the cartridge body.

In some aspects of the disclosure, each first staple receiving pocket of the plurality of first staple receiving pockets defines a longitudinal axis that is parallel to the longitudinal axis of the cartridge body.

In certain aspects of the disclosure, the plurality of first staple receiving pockets is aligned in three rows on the first side of the central knife slot.

In aspects of the disclosure, each first staple forming pocket of the plurality of first staple forming pockets defines a longitudinal axis that is parallel to the longitudinal axis of the anvil plate.

Various aspects of the disclosure are described herein below with reference to the drawings, wherein:.

The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the aspects of the disclosure are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.

In this description, the term "proximal" is used generally to refer to that portion of the device that is closer to a clinician, while the term "distal" is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term "endoscopic" is used generally used to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through a small diameter incision or cannula. Further, the term "clinician" is used generally to refer to medical personnel including doctors, nurses, and support personnel.

The disclosure is directed to a surgical stapling device having a tool assembly that minimizes damage to a tissue specimen that requires pathological examination. The tool assembly includes a staple cartridge having a cartridge body that defines a central knife slot, rows of first staple receiving pockets on one side of the central knife slot, and a row of staple receiving pockets on a second side of the knife slot. The first staple receiving pockets receive first staples having a substantially U-shaped configuration that can be formed into a B-shape. The second staple receiving slots receive substantially Y-shaped second staples which minimize damage to tissue and can be removed from the tissue more easily to allow for pathological examination of the tissue. The stapling device includes an anvil having a staple forming surface for forming the first and second staples.

<FIG> illustrates the disclosed surgical stapling device shown generally as stapling device <NUM> which includes a handle assembly <NUM>, an elongate body <NUM>, and a tool assembly <NUM>. Although not described in detail herein, the tool assembly <NUM> can form part of a reload assembly <NUM> that is releasably coupled to the elongate body <NUM> and includes a proximal body portion 16a and the tool assembly <NUM>. Alternately, the tool assembly <NUM> can be secured directly to a distal portion 14a of the elongate body <NUM>.

The elongate body <NUM> defines a longitudinal axis "X". The handle assembly <NUM> includes a body <NUM> that defines a hand grip 18a, a trigger <NUM> that is mounted on the body <NUM> and is movable towards the hand grip 18a, and a rotation knob <NUM>. The rotation knob <NUM> is rotatably supported on a distal portion of the body <NUM> of the handle assembly <NUM> and supports the elongate body <NUM> to facilitate rotation of the elongate body <NUM> and the tool assembly <NUM> in relation to the handle assembly <NUM> about the longitudinal axis "X". The trigger <NUM> is manually operable to control operation of the various functions of the stapling device <NUM> including approximation, firing and cutting. In aspects of the disclosure, the handle assembly <NUM> also supports an articulation knob <NUM> which is operable to pivot the tool assembly <NUM> about a pivot member defining an axis "Z" (<FIG>) that is transverse to the longitudinal axis "X" of the elongate body <NUM>. Although the stapling device <NUM> is illustrated as a manually operated stapling device, it is envisioned that aspects of this disclosure are suitable for use with robotically controlled stapling devices and electrically powered stapling devices. <CIT> (the '<NUM> Patent) discloses a surgical stapling device including an electrically powered handle assembly and <CIT> (the '<NUM> Patent) discloses a manually actuated handle assembly. For a more detailed description of construction and operation of an exemplary handle assembly and elongate body <NUM> which are suitable for use with the tool assembly <NUM> of the stapling device <NUM>, see, e.g., the '<NUM> and '<NUM> Patents.

<FIG> illustrate the tool assembly <NUM> of the stapling device <NUM> (<FIG>). The tool assembly <NUM> includes an anvil assembly <NUM> and a cartridge assembly <NUM>. The anvil assembly <NUM> and the cartridge assembly <NUM> are movable in relation to each other between an open position (<FIG>) and a clamped position. The anvil <NUM> includes a base member <NUM> and an anvil plate <NUM> that is coupled to the base member <NUM>. The anvil plate <NUM> has a staple forming surface <NUM> (<FIG>) that defines a central knife slot <NUM> and a plurality of first staple forming pockets 124a positioned on one side of the central knife slot <NUM> and a plurality of second staple forming pockets 124b formed on the other side of the central knife slot <NUM>. The staple forming pockets 124a and 124b are described in further detail below. For a detailed description of exemplary aspects of the anvil assembly <NUM>, see the '<NUM> Patent.

The cartridge assembly <NUM> includes a cartridge channel <NUM> and a staple cartridge <NUM>. The cartridge channel <NUM> defines a cavity 130a (<FIG>) that receives the staple cartridge <NUM>. In aspects of the disclosure, the staple cartridge <NUM> is removable from the cartridge channel <NUM> to facilitate reuse of the stapling device <NUM>. Alternately, the staple cartridge <NUM> can be fixedly secured within the cavity 130a of the cartridge channel <NUM> and the reload <NUM> (<FIG>) can be removed from the elongate body <NUM> of the stapling device <NUM> to facilitate reuse of the stapling device <NUM>.

The staple cartridge <NUM> includes a cartridge body <NUM> that defines a central knife slot <NUM> and a plurality of first staple receiving pockets 144a positioned on one side of the central knife slot <NUM> and a plurality of second staple receiving pockets 144b positioned on the other side of the central knife slot <NUM>. The staple receiving pockets 144a on the first side of the central knife slot <NUM> are illustrated as being aligned in three rows. However, it is envisioned that two or more rows of staple receiving pockets 144a can be provided in the cartridge body <NUM>. In aspects of the disclosure, the first staple receiving pockets 144a have a linear configuration and extend in a direction that is parallel to a longitudinal axis of the cartridge body <NUM>. The staple receiving pockets 144b on the second side of the central knife slot <NUM> are substantially Y-shaped (<FIG>) and are longitudinally aligned in a single row along the length of the cartridge body <NUM>. Each of the staple receiving pockets 144a receives a first staple <NUM> and each of the staple receiving pockets 144b receives a second staple <NUM>.

<FIG> illustrates one of the first staples <NUM>. Each of the is substantially U-shaped and is aligned with a respective first staple forming pockets 124a formed in the staple forming surface <NUM> (<FIG>) of the anvil plate <NUM> of the anvil assembly <NUM> when the tool assembly is in the clamped position. Each of the staples <NUM> is supported on a pusher <NUM> on the first side of the central knife slot <NUM> within the cartridge body <NUM> and includes a back span <NUM> and a leg <NUM> that extends from each end of the back span <NUM>. The back span <NUM> is supported on a respective pusher <NUM> and the legs <NUM> extend towards the anvil assembly <NUM>. Each of the legs <NUM> has a tapered end 158a that is configured to pierce tissue. In some aspects of the disclosure, the staples <NUM> are formed from titanium and the legs <NUM> and the back span <NUM> line in a common plane prior to formation of the staple <NUM>. In some aspects of the disclosure, two or more, e.g., three, pushers <NUM> are coupled together by a sled <NUM> and move as a single unit when the stapling device is fired.

<FIG> and <FIG> illustrate one of the second staples <NUM>. Each of the second staples <NUM> is substantially Y-shaped and includes three legs including a first leg <NUM>, a second leg <NUM>, and a third leg <NUM>. The first and third legs <NUM> and <NUM>, respectively, are interconnected by a first back span <NUM>, and the second and third legs <NUM> and <NUM>, respectively, are interconnected by a second back span <NUM>. In aspects of the disclosure, ach of the three legs includes a tapered tip 160a, 162a, and 164a that is configured to pierce tissue. The first and second back spans <NUM> and <NUM>, respectively, of each of the second staples <NUM> are supported on a respective pusher <NUM> such that the second staples are aligned with a respective second staple forming pockets 124b formed in the staple forming surface <NUM> (<FIG>) of the anvil plate <NUM> of the anvil assembly <NUM> when the tool assembly is in the clamped position.

Each of the pushers <NUM> includes a substantially V-shaped body <NUM> and a sled <NUM> that supports the V-shaped body <NUM>. The sled <NUM> includes a tapered cam surface <NUM>. The V-shaped body <NUM> includes a substantially V-shaped support surface <NUM> that supports the first and second back spans <NUM> and <NUM> of a respective one of the second staples <NUM> such that the first, second, and third legs <NUM>, <NUM>, and <NUM> of each of the respective staples <NUM> projects towards the anvil assembly <NUM>.

The staple cartridge <NUM> of the cartridge assembly <NUM> as illustrated in <FIG> also includes an actuation sled <NUM> and a cartridge cover <NUM>. The actuation sled <NUM> is movable from a retracted position within the cartridge body <NUM> to an advanced position into engagement with the sleds <NUM> and <NUM> of the pushers <NUM> and <NUM> to sequentially eject the first and second staples <NUM> and <NUM> from the cartridge body <NUM> of the staple cartridge <NUM>. The '<NUM> Patent describes the interaction between an actuation sled and pushers to eject staples from a cartridge body of a staple cartridge in further detail. The cartridge cover <NUM> is coupled to the bottom of the cartridge body <NUM> to prevent the staples and pushers from falling from the cartridge body <NUM> prior to insertion of the staple cartridge <NUM> into the channel member <NUM>.

In aspects of the disclosure, the tool assembly <NUM> includes a clamping member <NUM> that is coupled to a drive assembly (not shown) that is supported within the proximal body portion 16a of the reload assembly <NUM> (or the elongate body <NUM> if a reload is not provided). The clamping member <NUM> is movable through the cartridge body <NUM> from a retracted position to an advanced position to advance the actuation sled <NUM> from its retracted position to its advanced position to eject the staples <NUM> and <NUM> from the cartridge body <NUM>. In aspects of the disclosure, the clamping member <NUM> includes a first beam <NUM>, a second beam <NUM>, and a central strut <NUM> that interconnects the first beam <NUM> and the second beam <NUM>. The first beam <NUM> is engaged with the anvil assembly <NUM> and the second beam <NUM> is engaged with the cartridge assembly <NUM> such that movement of the clamping member <NUM> from its retracted position to its advanced position not only advances the actuation sled <NUM> within the cartridge body <NUM> but moves the tool assembly <NUM> from the open position to the clamped position. In aspects of the disclosure, the central strut <NUM> supports a knife blade <NUM> that is movable through the central knife slots <NUM> and <NUM> in the anvil plate <NUM> of the anvil assembly <NUM> and in the cartridge body <NUM> of the cartridge assembly <NUM> to cut tissue clamped between the anvil assembly <NUM> and the cartridge assembly <NUM>.

<FIG> illustrates the staple forming surface <NUM> of the anvil plate <NUM> of the anvil assembly <NUM> including the plurality of first and second staple forming pockets 124a and 124b (<FIG>) that are positioned on opposite sides of the central knife slot <NUM>. The staple forming pockets 124a are aligned in rows on a first side of the central knife slot <NUM> and are positioned to receive the staples <NUM>. The staple forming pockets 124a are longitudinally aligned with a longitudinal axis of the anvil assembly <NUM> and are positioned to receive the legs <NUM> of the staples <NUM> and form the each of the staples <NUM> into a substantially B-shape. Although three rows of staple forming pockets 124a are illustrated on the first side of the central knife slot <NUM>, it is envisioned that two or more rows of staple forming pockets 124a can be provided. When the tool assembly <NUM> is in the clamped position, each of the staple forming pockets 124a is in juxtaposed alignment with one of the staple receiving pockets 144a (<FIG>) of the cartridge body <NUM> of the staple cartridge <NUM>.

As summarized above, the staple forming pockets 124b defined by the staple forming surface <NUM> of the anvil assembly <NUM> are positioned on a second side of the central knife slot <NUM> to receive the substantially Y-shaped staples <NUM> (<FIG>) supported within the cartridge body <NUM> of the staple cartridge <NUM>. The staple deforming pockets 124b are longitudinally aligned along the second side of the central knife slot <NUM> and are Y-shaped to receive the legs <NUM>, <NUM>, and <NUM> of the staples <NUM> when the staples are ejected from the cartridge body <NUM>. When the tool assembly <NUM> is in the clamped position, each of the staple forming pockets 124b is in juxtaposed alignment with one of the staple receiving pockets 144b (<FIG>) of the cartridge body <NUM> of the staple cartridge <NUM>.

When the stapling device <NUM> (<FIG>) is fired, the clamping member <NUM> (<FIG>) is advanced through the anvil assembly <NUM> and the cartridge assembly <NUM> to initially move the tool assembly <NUM> (<FIG>) from the open position to the clamped position and to subsequently advance the actuation sled <NUM> through the cartridge body <NUM> of the staple cartridge <NUM>. As the actuation sled <NUM> advances through the cartridge body <NUM>, the actuation sled engages the pushers <NUM> and <NUM> to sequentially eject the rows of first staples <NUM> and row of second staples <NUM> from the cartridge body <NUM> into the first and second staple receiving pockets 144a and 144b, respectively. As the first staples <NUM> exit the first staple receiving pockets 144a, the first staples <NUM> are sequentially received within and formed by the first staple forming pockets 124a and are formed into a substantially B-shaped configuration such that three lines of staples <NUM> are formed in the tissue "T". Similarly, as the staples <NUM> exit the second staple receiving pockets 144b, the second staples <NUM> are sequentially received within and formed by the second staple forming pockets 124b. The knife <NUM> (<FIG>) of the clamping member <NUM> moves through the knife slots <NUM> and <NUM> of the anvil and cartridge assemblies <NUM> and <NUM> to cut tissue that is clamped between the anvil and cartridge assemblies <NUM> and <NUM>.

<FIG> illustrates one of the second staple forming pockets 124b. Each of the second staple forming pockets 124b defines a substantially Y-shaped channel <NUM> that includes a first channel portion <NUM> that receives the first leg <NUM> of a staple <NUM>, a second channel portion <NUM> that receives the second leg <NUM> of the staple <NUM>, and a third channel portion <NUM> that receives the third leg <NUM> of the staple <NUM>. The first and second channel portions <NUM> and <NUM> of the second staple forming pocket are configured to form the first and second legs <NUM> and <NUM> of the first staple <NUM> over a curved path towards the third leg <NUM> of the staple <NUM>. The third channel portion <NUM> of the second staple forming pocket 124b is configured to form the third leg <NUM> of the second staple <NUM> over a curved path towards the first and second legs <NUM> and <NUM> of the second staples <NUM>.

<FIG> illustrates one of the staples <NUM> in a formed state in tissue "T". As illustrated, tissue "T" is captured between the first, second, and third legs <NUM>, <NUM>, and <NUM> of the second staple <NUM> and the back spans <NUM> and <NUM> of the second staples <NUM>. The first and second legs <NUM> and <NUM> of the second staple <NUM> are curved upwardly towards the third leg <NUM>, and the third leg <NUM> of the second staple <NUM> is positioned between and curved downwardly towards the first and second legs <NUM> and <NUM>.

Claim 1:
A tool assembly (<NUM>) comprising:
a staple cartridge (<NUM>) including:
a cartridge body (<NUM>) defining a longitudinal axis, a first central knife slot (<NUM>), a plurality of first staple receiving slots(144a), and a plurality of second staple receiving slots(144b), the plurality of first staple receiving slots aligned in rows on a first side of the first central knife slot, the plurality of second staple receiving slots aligned in a row on a second side of the first central knife slot, each of the plurality of second staple receiving slots having a Y-shaped configuration;
a plurality of first staples(<NUM>), each first staple of the plurality of first staples received within one of the plurality of first receiving slots; and
a plurality of second staples(<NUM>), each second staple of the plurality of second staples received within one of the plurality of second staple receiving slots and having a Y-shaped configuration; and
an anvil (<NUM>) including an anvil plate (<NUM>) defining a longitudinal axis and having a staple forming surface(<NUM>), the staple forming surface defining a second central knife slot(<NUM>), a plurality of first staple forming pockets(124a), and a plurality of second staple forming pockets(124b), the plurality of first staple forming pockets aligned in rows on a first side of the second central knife slot, and the plurality of second staple forming pockets aligned in a row on a second side of the second central knife slot, each second staple forming pocket of the plurality of second staple forming pockets being aligned in a row on a second side of the second central knife slot and having a Y-shape.