Patent Description:
In addition, this application is a continuation-in-part of <CIT>, which is a national stage of <CIT>, which claims the benefit of, and priority to, <CIT>.

The present disclosure relates to circular surgical staplers and channel guides for use therewith. More particularly, the present disclosure relates to circular surgical staplers and their methods of use including a shell assembly having a port in communication with a body lumen.

Circular stapling apparatuses may be used in endoscopic procedures, laparoscopic procedures, or through natural body orifices, for fastening tissue. The circular stapling apparatuses may be powered or manually-operated and may include a tool assembly that is configured to operably couple to a distal end of an elongated member that extends from a handle assembly. The handle assembly may be reusable and the tool assembly may be disposable. The tool assembly may include an anvil assembly and a cartridge assembly that houses one or more fasteners therein.

In use, a circular stapling apparatus (or circular surgical staplers) may be used to reattach rectum portions that were previously transected. In this instance, a physician may insert a distal end (including an anvil assembly) of the circular stapling apparatus into a rectum of a patient and maneuver the distal end up the colonic tract of the patient toward the transected rectum portions. The physician may also insert the remainder of the circular stapling apparatus (including the cartridge assembly) through an incision and toward the transected rectum portions. The anvil and cartridge assemblies are approximated toward one another and staples are ejected from the cartridge assembly toward the anvil assembly to form the staples in tissue to affect an end-to-end anastomosis.

After the end-to-end anastomosis has been effected, the circular stapling apparatus is removed from the surgical site. The physician may use a sigmoidoscope or other suitable device to inspect the anastomosis for bleeding, patency, and/or blood perfusion. In certain instances, the physician uses the sigmoidoscope to introduce CO<NUM> into the colonic tract to check for leaks adjacent the anastomosis.

<CIT>, a document according to Article <NUM>(<NUM>) EPC, shows an adapter assembly for connecting a handle assembly with a loading unit. It has a trocar assembly supported within an elongate case from which a magnetized trocar unit is extended.

<CIT> relates to circular staplers for performing rectal mucosectomies and other surgical procedures. The circular staplers include a shaft having a proximal and a distal end, a cartridge assembly having a plurality of staples and operatively coupled to the distal end of the shaft, the cartridge assembly having a housing and a distal end defining an inner chamber, an anvil assembly operatively coupled to the cartridge assembly, and a channel adapted to communicate with a source of vacuum and the cartridge assembly to transmit a vacuum to the inner chamber of the cartridge assembly for drawing tissue into the inner chamber of the cartridge assembly.

While the aforementioned circular stapling apparatuses are suitable for their intended purposes, it may be beneficial to provide a circular stapling apparatus including a port to provide a passageway to the surgical site, as doing so may reduce the amount of instruments and/or incisions necessary to perform the surgical procedure. Additionally, it may be beneficial to provide a channel guide for use with a circular stapling apparatus, as doing so may reduce the amount of instruments and/or incisions necessary to perform the surgical procedure.

The present disclosure relates to an end effector for use with a circular stapling apparatus. The end effector includes a shell assembly, a port and a stepped lumen. The shell assembly is configured to support a cartridge assembly thereon. The shell assembly includes an outer wall. The port is disposed on the outer wall of the shell assembly. The stepped lumen is disposed in fluid communication with the port, and extends through the outer wall of the shell assembly.

In disclosed embodiments, the stepped lumen includes a first portion disposed in fluid communication with the port, and a second portion disposed in fluid communication with the first portion. The first portion is disposed at a first angle with respect to the second portion. It is disclosed that the first angle may be between about <NUM>° and about <NUM>°, or equal to about <NUM>°.

It is further disclosed that the stepped lumen includes a third portion disposed in fluid communication with the second portion. The second portion is disposed at a second angle with respect to the third portion. It is disclosed that the second angle may be between about <NUM>° and about <NUM>°, or equal to about <NUM>°. In disclosed embodiments, the first angle is equal to the second angle.

The present disclosure also relates to a method of performing a surgical procedure. The method comprises positioning a channel guide in engagement with a circular stapling apparatus such that an elongate passageway of the channel guide is disposed externally to and adjacent an elongated member of the circular stapling apparatus, aligning an aperture of a mounting portion of the channel guide with an opening of a shell assembly of the circular stapling apparatus, performing a surgical procedure with the circular stapling apparatus, and introducing at least one of a fluid or a device through the elongate passageway of the channel guide and through the aperture of the mounting portion of the channel guide.

In disclosed embodiments, positioning the channel guide in engagement with the circular stapling apparatus includes moving the mounting portion of the channel guide in a distal-to-proximal direction to mechanically engage the shell assembly of the circular stapling apparatus.

It is further disclosed that the method includes rotating a mounting portion of the channel guide with respect to the shell assembly while the channel guide is engaged with the circular stapling apparatus.

Additionally, it is disclosed that introducing at least one of a fluid or a device through the aperture of the mounting portion includes delivering fluid distally through the elongate passageway of the channel guide, through the aperture, and to a surgical site.

In disclosed embodiments, introducing at least one of a fluid or a device through the aperture of the mounting portion includes removing fluid from a surgical site through the aperture of the channel guide and proximally through the elongate passageway of the channel guide.

It is further disclosed that introducing at least one of a fluid or a device through the aperture of the mounting portion includes advancing a camera distally through the elongate passageway of the channel guide, through the aperture, and to a surgical site.

Additionally, it is disclosed that introducing at least one of a fluid or a device includes introducing at least one of a guide wire or an endoscopic camera through the elongate passageway of the channel guide, through the aperture, and to a surgical site.

In aspects of the present disclosure, a method of inserting a circular stapling apparatus into a body lumen includes inserting a distal portion of a shell assembly of the circular stapling apparatus in an entrance to a body lumen, introducing an insufflation fluid through an aperture defined in an outer surface of the shell assembly, and inserting a remainder of the shell assembly and a portion of an elongated member of the circular stapling apparatus into the body lumen. Introducing the insufflation fluid through the aperture flows insufflation fluid into the body lumen.

In aspects, introducing the insufflation fluid through the aperture includes inserting a hose through the port such that the hose extends from within the shell assembly and into the body lumen. Introducing the insufflation fluid through the aperture may include the insufflation fluid being a liquid that lubricates the body lumen. Additionally or alternatively, introducing the insufflation fluid through the aperture may include increasing a volume of the body lumen.

In some aspects, the method includes engaging a channel guide with the aperture of the shell assembly. Engaging the channel guide with the aperture of the shell assembly may include positioning a mounting portion of the channel guide about the shell assembly. Introducing the insufflation fluid through the aperture includes introducing the insufflation fluid through a passageway that is defined by the channel guide. The passageway may be in fluid communication with the aperture.

In certain aspects, engaging the engaging the channel guide with the aperture of the shell assembly includes inserting a nipple of the channel guide into the aperture of the shell assembly. Inserting the nipple of the channel guide into the aperture may include securing the nipple to the shell assembly with tabs that extend from the nipple. Engaging the channel guide with the aperture of the shell assembly may occur after inserting the distal portion of the shell assembly of the circular stapling apparatus into a body lumen.

In particular aspects, engaging the channel guide with the aperture of the shell assembly includes moving the mounting portion of the channel guide in a distal-to proximal direction to mechanically engage the shell assembly. The method may include rotating the mounting portion of the channel guide with respect to the shell assembly while the channel guide is engaged with the circular stapling apparatus. The method may include advancing a camera distally through the channel guide, through the aperture, and to a surgical site. Additionally or alternatively, the method may include advancing a guide wire through the channel guide, through the aperture, and to a surgical site.

In another aspect of the present disclosure, a method of removing a circular stapling apparatus from a body lumen includes withdrawing a distal portion of a shell assembly of a circular stapling apparatus from a body lumen and introducing an insufflation fluid through an aperture defined in an outer surface of the shell assembly such that the insufflation fluid flows into the body lumen while withdrawing the distal portion.

In aspects, introducing the insufflation fluid through the aperture includes supplying the insufflation fluid through a hose in communication with the port such that the hose extends from within the shell assembly into the body lumen. Introducing the insufflation fluid through the aperture may include the insufflation fluid being a liquid which lubricates the body lumen. Introducing the insufflation fluid through the aperture may include increasing a volume of the body lumen.

Further, to the extent consistent, any of the aspects and/or embodiments described herein may be used in conjunction with any or all of the other aspects described herein.

Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:.

Particular embodiments of the present circular surgical staplers will be described herein with reference to the accompanying figures. As shown in the figures and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the term "proximal" refers to the portion of the device that is closer to the user and the term "distal" refers to the portion of the device that is farther from the user. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.

<FIG> illustrates a powered circular stapling apparatus <NUM> in accordance with embodiments of the present disclosure. Generally, circular stapling apparatus <NUM> includes a housing or handle assembly <NUM> having an actuator <NUM>, and an elongated member <NUM> extending distally from handle assembly <NUM>. In the illustrated embodiment, elongated member <NUM> is curved. However, it is envisioned that the elongated member <NUM> may be linear to suit a particular surgical procedure, e.g., mucosectomy, hemorrhoidectomy, etc. A tool assembly <NUM> (e.g., a multi-use loading unit, or a single-use loading unit) is coupled to or is configured to operably couple to a distal end of elongated member <NUM> and includes an end effector <NUM>. In disclosed embodiments, a proximal portion of the tool assembly <NUM> is formed as a single component with the elongated member <NUM>.

End effector <NUM> includes a shell assembly <NUM> that is configured to support a cartridge assembly <NUM> thereon. Cartridge assembly <NUM> is configured to house a plurality of fasteners (not shown) and includes a corresponding plurality of pusher members <NUM> (<FIG>) that are operatively engagable with the fasteners to eject the fasteners from the cartridge assembly <NUM>. While fasteners are not shown in the accompanying figures, it is known in the art to include fasteners within a cartridge assembly. As such, the present disclosure includes a cartridge assembly <NUM> with a plurality of fasteners housed therein.

End effector <NUM> also includes an anvil assembly <NUM> that is supported to move in relation to the cartridge assembly <NUM> between spaced and approximated positions. Anvil assembly <NUM> includes a plurality of pockets or depressions (not explicitly shown) that are each configured to receive and deform a fastener when the fasteners are deployed from cartridge assembly <NUM>. Additionally, a channel guide <NUM> including a mounting portion <NUM> and an elongate passageway <NUM> is coupled to the shell assembly <NUM> as described in further detail below.

<FIG> illustrates a manually operated circular stapling apparatus <NUM> in accordance with embodiments of the present disclosure. Circular stapling apparatus <NUM> includes a handle assembly <NUM>, an elongated member <NUM> extending distally therefrom, a tool assembly <NUM>, which may be removably or fixedly coupled to the elongated member <NUM>, and an end effector <NUM>. The elongated body <NUM> extends distally from a distal end portion of the handle assembly <NUM> to a proximal end portion of the tool assembly <NUM>. End effector <NUM> includes a shell assembly <NUM> that is configured to support a cartridge assembly <NUM> thereon, and an anvil assembly <NUM>. Cartridge assembly <NUM> is configured to house a plurality of fasteners (not shown) and includes a corresponding plurality of pusher members that are substantially identical to pusher members <NUM> (<FIG>) and which are operatively engagable with the fasteners (not shown). Anvil assembly <NUM> is supported to move in relation to cartridge assembly <NUM> between spaced and approximated positions and includes a plurality of pockets or depressions (not explicitly shown) that are configured to receive and deform corresponding fasteners when the fasteners are deployed from cartridge assembly <NUM>. The handle assembly <NUM> includes a rotatable advancing member <NUM> for longitudinally moving anvil assembly <NUM> with respect to cartridge assembly <NUM> and a pivotable trigger member <NUM> for ejecting fasteners from cartridge assembly <NUM>. Additionally, a channel guide <NUM> including a mounting portion <NUM> and an elongate passageway <NUM> is coupled to the shell assembly <NUM>.

Further details of circular stapling apparatuses are disclosed in <CIT>, <CIT>, <CIT>and <CIT>.

With particular reference to <FIG>, embodiments of circular stapling apparatus <NUM> are shown. Additionally, while circular stapling apparatus <NUM> is not explicitly shown in <FIG>, the features disclosed in <FIG> are also applicable to the embodiments of circular stapling apparatus <NUM>. Here, instead of channel guide <NUM>, shell assembly <NUM> includes a port <NUM> disposed thereon. Port <NUM> is formed on an exterior wall of the shell assembly <NUM> and is configured to receive an elongated and/or flexible instrument (e.g., an endoscopic camera "EC," a tube associated with an irrigation device "ID" and/or a suction device "SD, etc.) therethrough, such that a portion of the elongated instrument can access the surgical site. Other surgical instruments that may be received in the port <NUM> for passage to the surgical site may include, but are not limited to, endoscopic graspers, endoscopic forceps, and endoscopic electrosurgical devices, which are shown schematically as "SI" in <FIG>. The port <NUM> also provides an inlet for fluid "F" through the shell assembly <NUM> to a surgical site, and an outlet for fluid from the surgical site though the shell assembly <NUM>, as will be described in detail below.

The port <NUM> is in fluid communication with a lumen <NUM> defined or secured within the shell assembly <NUM>. The lumen <NUM> has a proximal end that is in fluid communication with port <NUM> and a distal, open end that may be positioned adjacent a distal end of a circular knife <NUM>, for example, which is provided in the shell assembly <NUM> to sever stapled tissue sections. As shown in <FIG>, the lumen <NUM> includes a first or proximal portion 52a, a second or intermediate portion 52b, and a third or distal portion 52c, which together define lumen <NUM> having a stepped or non-linear configuration. That is, the proximal portion 52a is disposed at an angle α1 with respect to the intermediate portion 52b, and the intermediate portion 52b is disposed at an angle α2 with respect to the distal portion 52c. It is envisioned that angle α1 may be between about <NUM>° and about <NUM>°; in embodiments angle α1 may be equal to about <NUM>°. It is envisioned that angle α2 may be between about <NUM>° and about <NUM>°; in embodiments angle α2 may be equal to about <NUM>°. It is further envisioned that angle α1 may be equal to or different from angle α2. Alternatively, other lumen configurations are envisioned.

A guide channel in the form of a hose <NUM> is couplable to the port <NUM> of the shell assembly <NUM>. The hose <NUM> may provide a passageway to the port <NUM> for a surgical instrument being inserted through the port <NUM>, e.g., an irrigation device "ID" or suction device "SD. " In the embodiment illustrated in <FIG>, the hose <NUM> is formed from a material that is relatively flexible (e.g., plastic, rubber, etc.). Alternatively, the hose <NUM> may be formed from a material that is relatively rigid (e.g. plastic, metal, etc.).

In embodiments, the hose <NUM> extends longitudinally at least partially along the elongated member <NUM>, <NUM> (<FIG> and <FIG>) and may be fixedly secured to a portion of the circular stapling apparatus <NUM> (e.g., the shell assembly <NUM>, the elongated member <NUM>, and/or the handle assembly <NUM>) via one or more suitable securement methods (e.g., low tack adhesives, clips, bands, press- or friction-fit, etc.), not explicitly shown. It is further envisioned that hose <NUM> can be any reasonable length and may extend beyond the circular stapling apparatus <NUM>.

A distal portion <NUM> (<FIG>) of the hose <NUM> may be coupled to the port <NUM> via one or more suitable coupling methods, e.g., adhesive, welding, etc. In embodiments, the distal portion <NUM> of the hose may be removably coupled to the port <NUM> such that the port <NUM> may receive different types of hoses and/or different sizes of hoses. In this instance, the port <NUM> and the distal portion <NUM> of the hose <NUM> may couple to one another via a press- or friction-fit connection, a mechanical interface, or other suitable coupling methods. Alternatively, hose <NUM> may slidingly engage port <NUM> without any connection therebetween.

With particular reference to <FIG>, the hose <NUM> includes a proximal end <NUM> that is configured to engage an irrigation device "ID," a suction device "SD," and/or another surgical instrument "SI," which are shown schematically in <FIG> as a single unit. Such irrigation/suction devices are known in the art and, therefore, are not described in further detail.

In embodiments, after an anastomosis has been created, the irrigation device "ID" can be coupled to the port <NUM> or the proximal end <NUM> of the hose <NUM> to circulate one or more suitable fluids "F" (e.g., saline, CO<NUM>, etc.) through the hose <NUM> and/or port <NUM>, and through the lumen <NUM> to the anastomosis site. As described above, introducing such fluids "F" into the colonic tract, for example, can be useful to check for leaks adjacent the anastomosis. The suction device "SD" may be coupled to the port <NUM> or the proximal end <NUM> of the hose <NUM> to remove fluid "F" from the anastomosis site, or to remove and/or suction other matter from the anastomosis site, e.g., tissue, etc..

In some embodiments, fluids "F" can be introduced to the anastomosis site during insertion of the stapling apparatus <NUM>. By introducing fluids "F" into the anastomosis site during insertion of the stapling apparatus <NUM>, the volume of the tissue lumen "T" can be increased to facilitate an injury-free insertion of the stapling apparatus <NUM> to the anastomosis site. Additionally or alternatively, introducing fluids "F" into the anastomosis site may lubricate the tissue lumen "T" to facilitate friction-free insertion of the stapling apparatus <NUM>.

Additionally, other devices may be coupled to or extend through port <NUM>. Such devices include endoscopic cameras "EC", guide wires, etc. Referring to <FIG>, endoscopic camera "EC" is shown extending through hose <NUM> and port <NUM>, and is within a tissue lumen "T. " Endoscopic cameras are known in the art and, therefore, are not described herein in further detail. In embodiments, before and/or after an anastomosis has been created, a distal end of the endoscopic camera "EC" may be inserted through the hose <NUM> and/or port <NUM> of the shell assembly <NUM>, and through the lumen <NUM> to the anastomosis site, for example. As described above, a user may use the endoscopic camera "EC" to inspect the anastomosis for bleeding, patency, and/or blood perfusion, for instance.

Additionally, it is envisioned that the stepped nature of lumen <NUM> helps maintain surgical instruments "SI" at a desired position within tissue. For example, when a flexible surgical instrument "SI" is inserted through the stepped lumen <NUM> such that a distal end of the surgical instrument "SI" is within tissue, the surgical instrument "SI" is less likely to move proximally with respect to the shell assembly <NUM> because of the non-linear path of the stepped lumen <NUM>. That is, a surgical instrument "SI" will be physically hindered as it travels through a stepped lumen <NUM>. By contrast, if the lumen <NUM> were linear, movement of fluid within the body tissue, contact between the surgical instrument "SI" and tissue, etc. may cause the surgical instrument "SI" to freely translate proximally or distally through such a linear lumen and thus not be optimally positioned.

Although only one port <NUM> is shown on the shell assembly <NUM> (<FIG>), it is envisioned that the shell assembly <NUM> may include a plurality of ports <NUM> that are positioned on the exterior surface thereof. In these embodiments, each port <NUM> may be in fluid communication with the lumen <NUM> defined in the shell assembly <NUM>. Alternatively, each port <NUM> may be in fluid communication with a corresponding lumen of a plurality of lumens <NUM> defined in the shell assembly <NUM>. In such embodiments, for example, the suction device "SD" can be coupled to a first port, and an endoscopic camera "EC" can be coupled to a second port.

In embodiments, the port <NUM> may extend longitudinally at least partially along the tool assembly <NUM> and/or the elongated member <NUM> of the circular stapling apparatus <NUM>. Additionally, the port <NUM> may be monolithically formed with the tool assembly <NUM> and/or the elongated member <NUM>. As can be appreciated, in such embodiments, hose <NUM> may be omitted.

It is envisioned that the lumen <NUM> can extend from the shell assembly <NUM> to the handle portion <NUM> (e.g., to a proximal end of the handle portion <NUM>). In such embodiments, the port <NUM> is positioned on the handle portion <NUM> and allows endoscopic camera "EC," irrigation device "ID," and/or suction device "SD" to be inserted from a location adjacent the handle portion <NUM>, through at least a majority of the circular stapling apparatus <NUM>, and into fluid communication with the anastomosis site, for example.

Referring to <FIG> a channel guide <NUM> according to embodiments of the present disclosure is illustrated. In <FIG>, the channel guide <NUM> is shown coupled to the circular stapling apparatus <NUM>. Channel guide <NUM> is configured to engage (either fixedly or removably) shell assembly <NUM> of circular stapling apparatus <NUM>.

Channel guide <NUM> includes a mounting portion <NUM> and an elongate passageway <NUM> extending proximally therefrom. Mounting portion <NUM>, which defines a longitudinal aperture <NUM>, is sized and configured to mechanically engage shell assembly <NUM> of circular stapling apparatus <NUM>.

More particularly, shell assembly <NUM> can be inserted (e.g., in a proximal-to-distal direction) at least partially through longitudinal aperture <NUM> of mounting portion <NUM>. That is, mounting portion <NUM> can be positioned onto shell assembly <NUM> in a distal-to-proximal direction. In such embodiments, a distal portion <NUM> of channel guide <NUM> can flex radially outwardly to allow a portion of shell assembly <NUM> having a larger outer diameter "OD" than an inner diameter "ID" of channel guide <NUM> to be inserted into the mounting portion <NUM>. Further, and with particular reference to <FIG>, channel guide <NUM> includes inwardly depending lip(s) or rib <NUM> (e.g., annular lips <NUM>) configured to be received within recess(es) <NUM> (e.g., annular recesses <NUM>) of shell assembly <NUM>. It is envisioned that the receipt of between lip(s) <NUM> within recess(es) <NUM> helps longitudinally align and sealingly secure the channel guide <NUM> to the shell assembly <NUM>. It is further envisioned that alternatively or in addition to lip(s) <NUM> and recess(es) <NUM>, channel guide <NUM> may be attached to shell assembly <NUM> with an adhesive.

It is also disclosed to mechanically engage channel guide <NUM> and circular stapling instrument <NUM> by first inserting elongated member <NUM> through longitudinal aperture <NUM> of mounting portion <NUM>, then engaging shell assembly <NUM> with a distal end of elongated member <NUM>, and then moving mounting portion <NUM> distally with respect to shell assembly <NUM>. Here, too, lip(s) <NUM> is received within recess(es) <NUM> to help longitudinally align and sealingly secure the channel guide <NUM> to shell assembly <NUM>.

Mounting portion <NUM> includes a body <NUM> defining an aperture <NUM> and a lumen <NUM> therein. Aperture <NUM> extends through a wall of body <NUM> and is disposed in fluid communication with lumen <NUM>, which extends through body <NUM> and through elongate passageway <NUM> of channel guide <NUM>. Additionally, aperture <NUM> of mounting portion <NUM> is configured to align with an opening <NUM> extending through an outer wall of shell assembly <NUM> that is in fluid communication with an interior space of shell assembly <NUM>. Thus, the lumen <NUM> of elongate passageway <NUM> of channel guide <NUM> is in fluid communication with opening <NUM> of shell assembly <NUM>, and with the interior space of shell assembly <NUM>. In disclosed embodiments, as shown in <FIG> and <FIG>, elongate passageway <NUM> is a tube that extends externally of and parallel to elongate body <NUM>. A proximal end of elongate passageway <NUM> may be disposed proximally of handle assembly <NUM>, aligned with a portion of handle assembly <NUM>, or disposed distally or handle assembly <NUM>. As can be appreciated, devices (e.g., an endoscopic camera "EC") and/or fluid "F" can travel through a proximal end of elongate passageway <NUM>, into the interior space of shell assembly <NUM>, and to the surgical site.

It is envisioned that aperture <NUM> extends around a portion (e.g., majority or entirety) of a perimeter of mounting portion <NUM>, thus facilitating radial alignment between aperture <NUM> and opening <NUM> of shell assembly <NUM>. Additionally, the engagement between annular lip(s) <NUM> and annular recess(es) <NUM> may facilitate and/or enable the relative rotation of channel guide <NUM> with respect to shell assembly <NUM>, e.g., to help align aperture <NUM> with opening <NUM> to provide a pathway to the surgical site.

In the illustrated embodiments, a distal end of mounting portion <NUM> includes a flange <NUM> extending along an outer periphery thereof. It is envisioned that flange <NUM> provides a surface for a user to grasp to facilitate coupling the channel guide <NUM> to the shell assembly <NUM>, for example. While flange <NUM> is shown on a distal part of mounting portion <NUM>, it is envisioned that flange <NUM> can be disposed on a different part of mounting portion <NUM> (e.g., on a proximal part thereof), and that mounting portion <NUM> can include more than one flange <NUM> thereon. For instance, it is envisioned that mounting portion <NUM> includes a first flange <NUM> on a proximal part thereof, and a second flange <NUM> on a distal part thereof.

It is further envisioned that channel guide <NUM> includes a seal member or grommet disposed in mechanical cooperation with aperture <NUM> and/or with a portion of lumen <NUM> to help seal or otherwise contain air or fluid pressurizations within tissue and/or to prevent spillage of such fluid.

Methods of using circular stapling apparatus <NUM>, <NUM> and/or channel guide <NUM>, as described above, are also disclosed herein. Additionally, the present disclosure includes methods of coupling channel guide <NUM> with circular stapling apparatus <NUM>, <NUM>, as disclosed herein.

For example, disclosed methods of performing a surgical procedure include selectively engaging channel guide <NUM> with circular stapling apparatus <NUM>, aligning aperture <NUM> of channel guide <NUM> with opening <NUM> of shell assembly <NUM>, performing a surgical procedure with circular stapling apparatus <NUM>, and transporting at least one of a fluid "F" or a device (e.g., an endoscopic camera "EC") through aperture <NUM> of channel guide <NUM>.

Additionally, embodiments of the disclosed methods include positioning channel guide <NUM> in engagement with circular stapling apparatus <NUM> such that elongate passageway <NUM> of channel guide <NUM> is disposed externally to and adjacent elongated member <NUM> of circular stapling apparatus <NUM>, aligning an aperture <NUM> of mounting portion <NUM> of channel guide <NUM> with opening <NUM> of shell assembly <NUM> of circular stapling apparatus <NUM>, performing a surgical procedure with circular stapling apparatus <NUM>, and introducing at least one of a fluid "F" or surgical instrument "SI" through elongate passageway <NUM> of channel guide <NUM> and through aperture <NUM> of mounting portion <NUM> of channel guide <NUM>.

Further aspects of the methods include positioning channel guide <NUM> in a distal-to-proximal direction to mechanically engage shell assembly <NUM> of circular stapling apparatus <NUM>, and rotating mounting portion <NUM> of channel guide <NUM> with respect to shell assembly <NUM> while channel guide <NUM> is engaged with circular stapling apparatus <NUM>. It is envisioned that rotation of mounting portion <NUM> with respect to the shell assembly <NUM> helps orient a surgical instrument "SI" in a desired location within tissue with respect to the shell assembly <NUM>, for example.

It is envisioned that channel guide <NUM> is usable with various different types of surgical instruments, including those that include a replaceable cartridge assembly <NUM>. It is further envisioned that channel guide <NUM> can be engaged and disengaged with circular stapling apparatus <NUM>, or that circular stapling apparatus <NUM> is manufactured to include channel guide <NUM> already engaged therewith.

Referring to <FIG>, embodiments of a circular stapling apparatus <NUM> are shown. The circular stapling apparatus <NUM> is similar to the circular stapling apparatus <NUM> detailed above with similar structures represented with reference numerals including a "<NUM>" preceding the previous reference numeral. Additionally, while circular stapling apparatuses <NUM> and <NUM> are not explicitly shown in <FIG>, the features disclosed in <FIG> are also applicable to the embodiments of circular stapling apparatuses <NUM> and <NUM>. With particular reference to <FIG>, the circular stapling apparatus <NUM> includes an end effector <NUM> including a shell assembly <NUM> that is releasably coupled to an elongate member <NUM>, and a guide channel or irrigation tube <NUM> that is coupled to the shell assembly <NUM>.

Referring to <FIG>, the irrigation tube <NUM> includes a flexible tube <NUM>, a distal coupling <NUM>, and a proximal coupling <NUM>. The flexible tube <NUM> has a distal portion <NUM> and a proximal portion <NUM> and defines a central lumen <NUM> and two channels <NUM> positioned on either side of the central lumen <NUM> between distal and proximal portions <NUM>, <NUM>. The flexible tube <NUM> may be constructed from a clear plastic that is extruded to form the flexible tube <NUM>. The flexible tube <NUM> has an inner surface 511a and an outer surface 511b. The inner surface 511a has a radius substantially equal to a radius of an outer surface of the elongate member <NUM> (<FIG>) of circular stapling apparatus <NUM> such that the inner surface 511a is in substantial contact with the elongate member <NUM> when the distal coupling <NUM> is secured to the shell assembly <NUM> as detailed below. With reference momentarily to <FIG>, the surface profile of inner surface 511a (e.g., the radius of curvature) is such that application of fluid/moisture (F) to inner surface 511a of irrigation tube <NUM> helps to adhere irrigation tube to elongate member <NUM> of circular stapling apparatus <NUM> by way of a suctioning effect.

The outer surface 511b of the flexible tube <NUM> has a radius slightly less than the radius of the inner surface 511a such that the outer surface 511b meets the inner surface 511a at edges <NUM>. The outer surface 511b is shaped such that the outer surface 511b forms a smooth transition with the outer surface of the elongate member <NUM> when the distal coupling <NUM> is secured to the shell assembly <NUM> as detailed below. With reference to <FIG>, the smooth transition between the outer surface 511b of the flexible tube <NUM> and the outer surface of the elongate member <NUM> allows a sphincter (S) to form a seal about the elongate member <NUM> with the irrigation tube <NUM> attached. Specifically, the smooth transition eliminates gaps between the flexible tube <NUM> and the elongate member <NUM> which may prevent a sphincter from fully sealing about the elongate member <NUM> when the irrigation tube <NUM> is attached, for example, as is the case with other irrigation tubes having transverse cross-sectional profiles that are circular or of other shape.

The distal coupling <NUM> includes a central connector <NUM> that extends proximally into the central lumen <NUM> defined by the flexible tube <NUM>. The central connector <NUM> may include ribs that engage walls defining the central lumen <NUM> to prevent the distal coupling <NUM> from separating from flexible tube <NUM>. The distal coupling <NUM> also includes one or more proximally extending protrusions <NUM> (<FIG>) that are each received within one of the passages <NUM> of the flexible tube <NUM> to secure the distal coupling <NUM> with the flexible tube <NUM>. Each protrusion <NUM> may be shaped to conform to the shape of a respective passage <NUM>. The distal coupling <NUM> also includes a nipple <NUM> that is substantially orthogonal to the central connector <NUM>. The nipple <NUM> and the central connector <NUM> define a coupler lumen <NUM> that is in fluid communication with the central lumen <NUM> of the flexible tube <NUM> when the central connector <NUM> is received within the central lumen <NUM>. The nipple <NUM> also includes tabs <NUM> on opposite sides of the nipple <NUM> and includes outer detents <NUM> that are configured to engage the shell assembly <NUM> to couple the distal coupling <NUM> to the shell assembly <NUM> as detailed below. The tabs <NUM> are resilient and biased outward.

The proximal coupling <NUM> includes a central connector <NUM> that extends distally into the central lumen <NUM> defined by the flexible tube <NUM>. The central connector <NUM> may include ribs that engage walls defining the central lumen <NUM> to prevent the proximal coupling <NUM> from separating from flexible tube <NUM>. The proximal coupling <NUM> also includes one or more distally extending protrusions <NUM> that are received within one of the passages <NUM> of the flexible tube <NUM> to secure the proximal coupling <NUM> with the flexible tube <NUM>. Each protrusion <NUM> may be shaped to conform to the shape of a respective passage <NUM>. The proximal coupling <NUM> includes a proximally extending connection <NUM> that is configured to couple to a fluid source. As shown, the proximally extending connection <NUM> is a male luer connector but it is contemplated that the proximally extending connection <NUM> may be a female luer connector or another known fluid coupling device. The proximally extending connection <NUM> and the central connector <NUM> define a coupler lumen <NUM> that is in fluid communication with the central lumen <NUM> when the central connector <NUM> is received within the central lumen <NUM>.

It is contemplated that the protrusions <NUM> and <NUM> may define openings in fluid communication with the respective passages <NUM> and that the proximal coupling <NUM> and the distal coupling <NUM> may include additional connectors to fluidly connect the passages with a fluid source and to the circular stapling apparatus <NUM>. In addition, the nipple <NUM> and/or the proximally extending connection <NUM> may be segmented such that a single connection may provide three distinct fluid channels between the distal and proximal couplings <NUM>, <NUM>. It is envisioned that each of the channels may provide a fluid to or withdraw a fluid from the circular stapling apparatus <NUM>.

Referring now to <FIG>, the shell assembly <NUM> defines an opening or port <NUM> that is in fluid communication with a lumen <NUM> defined within the shell assembly <NUM>. The lumen <NUM> passes through the shell assembly <NUM> such that the port <NUM> is in fluid communication with an anastomosis site through the lumen <NUM>. The port <NUM> is defined by walls <NUM> that extend inward from an outer surface of the shell assembly <NUM>.

With reference to <FIG>, the nipple <NUM> of the distal coupling <NUM> of the irrigation tube <NUM> is coupled to the port <NUM> of the shell assembly <NUM>. As the nipple <NUM> is inserted into the port <NUM>, the detents <NUM> engage the walls <NUM> such that the tabs <NUM> are urged inwardly as the nipple <NUM> enters the port <NUM>. When the detents <NUM> extend past the walls <NUM>, the resilience of the tabs <NUM> snap the detents <NUM> outward to engage an inner surface of the walls <NUM> to couple the distal coupling <NUM> to the port <NUM>. When the distal coupling <NUM> is coupled to the port <NUM>, the nipple <NUM> seals the port <NUM> such that fluid may flow into the lumen <NUM> of the shell assembly <NUM> from the central lumen <NUM> of the irrigation tube <NUM> and/or from the lumen <NUM> of the shell assembly <NUM> into the central lumen <NUM> of the irrigation tube <NUM>. As shown, when the distal coupling <NUM> is coupled to the shell assembly <NUM>, the irrigation tube <NUM> is non-removably attached to the shell assembly <NUM>. However, it is contemplated that the irrigation tube <NUM> may include a release mechanism (not shown) that allows the distal coupling <NUM> to releasably couple to the shell assembly <NUM>.

With particular reference to <FIG>, a method of inserting the stapling apparatus <NUM> into a tissue lumen "T" in accordance with the present disclosure is disclosed. While detailed herein below with reference to apparatus <NUM>, it will be appreciated that the method may also be used with stapling apparatuses <NUM> and <NUM>. Initially, the stapling apparatus <NUM> is brought into close proximity with the tissue lumen "T" such that the shell assembly <NUM> can be inserted into an end of the tissue lumen "T" as shown in <FIG>.

With the shell assembly <NUM> positioned within the end of the tissue lumen "T", an insufflation fluid "F" is introduced through the port <NUM> defined in the shell assembly <NUM>. The insufflation fluid "F" can be a liquid, e.g., saline, that lubricates the tissue lumen "T" and increases the volume of the tissue lumen "T" to facilitate atraumatic insertion of the shell assembly <NUM> into the tissue lumen "T". When the tissue lumen "T" is insufflated to an appropriate degree, the stapling apparatus <NUM> can be advanced to the anastomosis site as detailed above.

After the stapling apparatus <NUM> is advanced to the anastomosis site, the stapling apparatus <NUM> is fired. After the stapling apparatus <NUM> is fired, the stapling apparatus <NUM> is removed from the patient. It has been shown that additional insufflation fluid "F" can be introduced through the port <NUM> as the stapling apparatus <NUM> is removed from the patient to assist in removing the stapling apparatus <NUM> from the patient. Specifically, the additional insufflation fluid "F" may expand the tissue lumen "T" and/or lubricate the tissue lumen "T" to assist in removing the stapling apparatus <NUM> from the tissue lumen "T".

The irrigation tube <NUM> may be provided as a part of a kit with a surgical stapling apparatus, e.g., surgical stapling apparatus <NUM>, <NUM>, <NUM>.

Claim 1:
A circular stapling apparatus comprising:
an end effector including a shell assembly configured to support a cartridge assembly thereon said cartridge assembly configured to house a plurality of fasteners, and comprising a distal portion, wherein said distal portion is configured to be inserted into an entrance to a body lumen;
an aperture defined in an outer surface of the shell assembly in fluid communication with a lumen of said shell assembly ; and
an elongated member releasably coupled from the shell assembly, further comprising a channel guide, wherein the channel guide defines a passageway, said passageway configured to be in fluid communication with the aperture,
characterised in that
the channel guide further comprises a nipple configured for insertion into the aperture of the shell assembly, wherein said nipple is secured to the shell assembly via tabs extending form the nipple.