Surgical staplers and related methods

Surgical staplers and methods of their use are provided. In one embodiment, a surgical stapler includes a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, a head assembly extending from the distal end of the tubular shaft, and an insertion guide configured to extend through the head assembly. The insertion guide includes an expandable member configured to move between a collapsed configuration and an expanded configuration.

TECHNICAL FIELD

The present disclosure relates generally to surgical instruments and methods, and more particularly to surgical staplers and related methods of using such staplers to perform an end-to-end anastomosis between two tubular tissue segments.

BACKGROUND

Various types of surgical procedures may necessitate anastomosis between two tubular tissue segments in order to restore the natural function of the tissue segments. For example, during colon and rectal resection surgery, a diseased or otherwise defective portion of the colon of a patient may be removed, and the colon segments above and below the removed portion may need to be reconnected to restore the natural flow through the colon. Traditionally, the upper and lower colon segments were rejoined by suturing the respective ends of the colon segments to one another. In recent years, surgical staplers have been developed for performing an end-to-end anastomosis between two tubular tissue segments, allowing clinicians to reconnect the tissue segments in a more efficient and reliable manner during a surgical procedure.

Existing surgical staplers for performing an end-to-end anastomosis generally may include an elongated tubular shaft, a handle attached to a proximal end of the tubular shaft, and a head assembly attached to a distal end of the tubular shaft. The head assembly may include an outer shell that contains a mechanism for forming a circular array of staples to connect two tubular tissue segments. For example, a staple guide may be fixedly positioned within the outer shell along a distal end thereof, and a staple pusher may be movably positioned within the outer shell and configured for advancing a plurality of staples through the staple guide. The head assembly also may include a mechanism for coring respective portions of the tissue segments being stapled to one another. For example, a circular knife may be movably positioned within the outer shell and configured for cutting inner portions of the tissue segments within the circular array of staples. The formation of the array of staples and the removal of the inner portions of the tissue segments may be facilitated by an anvil that is removably attached to a trocar of the head assembly. The trocar may be movably positioned within the outer shell and configured to draw an anvil head of the anvil adjacent to the distal end of the outer shell. In this manner, the staples may be advanced through the staple guide, through respective portions of the tissue segments, and against the anvil head to facilitate desired deformation of the staples. Additionally, the circular knife may be advanced through respective portions of the tissue segments and against the anvil head to cut and remove inner portions of the tissue segments within the circular array of staples.

When existing surgical staplers are used to perform an end-to-end anastomosis between two colon segments, the head assembly and a portion of the tubular shaft of the stapler may be inserted through the anus of the patient and advanced through the rectum to the end of the lower color segment, while the handle remains outside of the patient to allow the clinician to control positioning and operation of the stapler. The head assembly generally may be relatively large in order to accommodate the various components for staple formation and for cutting the inner portions of the colon segments being joined. Further, the distal end face of the head assembly may be flat or relatively flat in order to cooperate with the mating portion of the anvil head, resulting in an abrupt edge along the outer circumference of the head assembly. In many instances, it may be challenging for the clinician to insert the head assembly through the anus and the rectum and advance the head assembly to the desired location at the end of the lower colon segment. For example, due to the size and/or shape of the head assembly, it may be difficult to advance the head assembly through the anus and then through the contours of the rectum without snagging on the mucosa folds. In some instances, as the head assembly is advanced to the desired location, the size and/or shape of the head assembly may result in injury to the surrounding anatomy and various complications for the patient. For example, introduction of the head assembly may result in anal sphincter injury, which may lead to loss of voluntary control of bowel function. Additionally, as the head assembly is moved to the desired location, it may engage and cause damage to the internal lining of the colon, which may lead to bleeding or potentially a leak along the respective region of the colon. Finally, in view of the known challenges in advancing the head assembly to the desired location, clinicians often may remove a larger portion of the colon than is truly needed in order to ease insertion and positioning of the head assembly within the patient.

There remains a need for improved surgical staplers and methods of using such staplers to perform an end-to-end anastomosis between two tubular tissue segments, such as colon segments following resection of a portion of the colon. In particular, it would be advantageous to provide a surgical stapler that eases insertion and advancement of a head assembly of the stapler to a desired location for performing the anastomosis, while reducing incidence of injury to the surrounding anatomy and complications for the patient.

BRIEF SUMMARY

Surgical staplers and methods of using such staplers to perform an end-to-end anastomosis between two tubular tissue segments are provided. According to one aspect, a surgical stapler is provided. In one embodiment, the surgical stapler includes a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, a head assembly extending from the distal end of the tubular shaft, and an insertion guide configured to extend through the head assembly. The insertion guide includes an expandable member configured to move between a collapsed configuration and an expanded configuration.

In some embodiments, the head assembly includes a distal end face, and the insertion guide is configured to extend distally beyond the distal end face of the head assembly. In some embodiments, the expandable member is configured to engage the distal end face of the head assembly when the expandable member is in the expanded configuration. In some embodiments, the expandable member is configured to be spaced apart from the distal end face of the head assembly when the expandable member is in the collapsed configuration. In some embodiments, the head assembly includes an outer shell including a central bore defined therein, and the insertion guide is configured to extend at least partially through the central bore. In some embodiments, the central bore has a proximal end and a distal end, and the insertion guide is configured to extend through the distal end of the central bore. In some embodiments, the outer shell also includes a lateral opening defined in an outer surface of the outer shell and in communication with the central bore, and the insertion guide is configured to extend through the lateral opening and into the central bore. In some embodiments, the insertion guide is configured to be inserted through the lateral opening and into the central bore when the expandable member is in the collapsed configuration. In some embodiments, the head assembly also includes a staple guide positioned within the central bore, and the insertion guide is configured to extend through a central aperture of the staple guide. In some embodiments, the head assembly also includes a circular knife positioned within the central bore, and the insertion guide is configured to extend through a central aperture of the circular knife. In some embodiments, the expandable member is configured to be positioned at least partially within the central bore when the expandable member is in the expanded configuration. In some embodiments, the expandable member is configured to be withdrawn from the central bore when the expandable member is in the collapsed configuration.

In some embodiments, the head assembly has a first outer diameter, the expandable member has a second outer diameter when the expandable member is in the collapsed configuration, and the second outer diameter is less than the first outer diameter. In some embodiments, the expandable member has a third outer diameter when the expandable member is in the expanded configuration, and the third outer diameter is equal to or greater than the first outer diameter. In some embodiments, the expandable member includes a balloon configured to radially expand and collapse to move the expandable member between the collapsed configuration and the expanded configuration. In some embodiments, the balloon is formed of an elastomeric material. In some embodiments, the balloon has a curved outer surface when the expandable member is in the expanded configuration. In some embodiments, the insertion guide also includes a tube extending from a proximal end of the expandable member and in fluid communication with an internal reservoir of the balloon. In some embodiments, the insertion guide also includes a port attached to a proximal end of the tube and configured to attach to a fluid delivery device. In some embodiments, the insertion guide is configured to extend through the tubular shaft and the head assembly.

In another embodiment, the surgical stapler includes a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, a head assembly extending from the distal end of the tubular shaft, and an insertion guide. The head assembly includes a distal end face and a central bore defined therein. The insertion guide is configured to be positioned at least partially within the central bore. The insertion guide includes an expandable member configured to move between a collapsed configuration and an expanded configuration. The expandable member is configured to be spaced apart from the distal end face when the expandable member is in the collapsed configuration, and the expandable member is configured to engage the distal end face when the expandable member is in the expanded configuration.

In some embodiments, the expandable member is configured to be positioned at least partially within the central bore when the expandable member is in the expanded configuration. In some embodiments, the head assembly has a first outer diameter, the expandable member has a second outer diameter when the expandable member is in the collapsed configuration, and the second outer diameter is less than the first outer diameter. In some embodiments, the expandable member has a third outer diameter when the expandable member is in the expanded configuration, and the third outer diameter is equal to or greater than the first outer diameter. In some embodiments, the head assembly also includes a lateral opening defined in an outer surface of the head assembly and in communication with the central bore, and the insertion guide is configured to extend through the lateral opening and into the central bore. In some embodiments, the head assembly also includes a staple guide positioned within the central bore, and the insertion guide is configured to extend through a central aperture of the staple guide. In some embodiments, the head assembly also includes a circular knife positioned within the central bore, and the insertion guide is configured to extend through a central aperture of the circular knife. In some embodiments, the expandable member includes a balloon configured to radially expand and collapse to move the expandable member between the collapsed configuration and the expanded configuration. In some embodiments, the insertion guide is configured to extend through the tubular shaft and the head assembly.

In still another embodiment, the surgical stapler includes a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, a head assembly extending from the distal end of the tubular shaft, and an insertion guide configured to extend through the head assembly. The insertion guide includes a balloon and a tube. The balloon is configured to move between a collapsed configuration and an expanded configuration. The tube extends from a proximal end of the balloon and is in fluid communication with an internal reservoir of the balloon.

In some embodiments, the head assembly includes a distal end face, and the insertion guide is configured to extend distally beyond the distal end face. In some embodiments,

In some embodiments, the balloon is configured to be spaced apart from the distal end face when the balloon is in the collapsed configuration, and the balloon is configured to engage the distal end face when the balloon is in the expanded configuration. In some embodiments, the head assembly comprises a central bore defined therein, and the insertion guide is configured to extend at least partially through the central bore. In some embodiments, the balloon is configured to be positioned at least partially within the central bore when the balloon is in the expanded configuration. In some embodiments, the head assembly also includes a lateral opening defined in an outer surface of the head assembly and in communication with the central bore, and the insertion guide is configured to extend through the lateral opening and into the central bore. In some embodiments, the head assembly also includes a staple guide and a circular knife positioned within the central bore, and the insertion guide is configured to extend through a central aperture of the staple guide and a central aperture of the circular knife. In some embodiments, the head assembly has a first outer diameter, the balloon has a second outer diameter when the balloon is in the collapsed configuration, and the second outer diameter is less than the first outer diameter. In some embodiments, the balloon has a third outer diameter when the balloon is in the expanded configuration, and the third outer diameter is equal to or greater than the first outer diameter. In some embodiments, the insertion guide is configured to extend through the tubular shaft and the head assembly.

In another aspect, a method of introducing a surgical stapler into a patient is provided. In one embodiment, the method includes the steps of advancing an insertion guide through a head assembly of the surgical stapler, such that the insertion guide extends distally beyond a distal end face of the head assembly, moving an expandable member of the insertion guide from a collapsed configuration to an expanded configuration, and inserting the expandable member and the head assembly into a tubular tissue structure of the patient while the expandable member is in the expanded configuration.

In some embodiments, the surgical stapler also includes a tubular shaft extending from a proximal end of the head assembly, and the method also includes advancing the insertion guide through the tubular shaft. In some embodiments, advancing the insertion guide through the head assembly includes advancing the expandable member through the head assembly while the expandable member is in the collapsed configuration. In some embodiments, the head assembly includes a central bore defined therein and a lateral opening defined in an outer surface of the head assembly and in communication with the central bore, and advancing the insertion guide through the head assembly includes advancing the expandable member through the lateral opening and at least partially through the central bore. In some embodiments, moving the expandable member from the collapsed configuration to the expanded configuration comprises engaging the distal end face with the expandable member. In some embodiments, the expandable member includes a balloon, and moving the expandable member from the collapsed configuration to the expanded configuration includes inflating the balloon. In some embodiments, the insertion guide also includes a tube extending from a proximal end of the balloon and in fluid communication with an internal reservoir of the balloon, and inflating the balloon includes delivering a fluid through the tube and into the internal reservoir.

In some embodiments, the head assembly has a first outer diameter, the expandable member has a second outer diameter when the expandable member is in the collapsed configuration, the expandable member has a third outer diameter when the expandable member is in the expanded configuration, the second outer diameter is less than the first outer diameter, and the third outer diameter is equal to or greater than the first outer diameter. In some embodiments, the method also includes the steps of advancing the expandable member and the head assembly through the tubular tissue structure to a target location, moving the expandable member from the expanded configuration to the collapsed configuration while the expandable member is at the target location, and removing the insertion guide from the head assembly. In some embodiments, the tubular tissue structure includes a segment of a colon of the patient.

In still another aspect, a method of using a surgical stapler to perform an end-to-end anastomosis between a first tubular tissue segment and a second tubular tissue segment of a patient is provided. In one embodiment, the method includes the steps of inserting an anvil of the surgical stapler at least partially into the first tubular tissue segment, advancing an insertion guide through a head assembly of the surgical stapler, such that the insertion guide extends distally beyond a distal end face of the head assembly, moving an expandable member of the insertion guide from a collapsed configuration to an expanded configuration, inserting the expandable member and the head assembly into the patient while the expandable member is in the expanded configuration, advancing the expandable member and the head assembly through the second tubular tissue segment to a target location adjacent an end of the second tubular tissue segment, moving the expandable member from the expanded configuration to the collapsed configuration while the expandable member is at the target location, removing the insertion guide from the head assembly, advancing a trocar of the surgical stapler through the end of the second tubular tissue segment, attaching the anvil to the trocar, and connecting the first tubular tissue segment to the second tubular tissue segment via a plurality of staples.

In some embodiments, the surgical stapler also includes a tubular shaft extending from a proximal end of the head assembly, and the method also includes advancing the insertion guide through the tubular shaft. In some embodiments, advancing the insertion guide through the head assembly includes advancing the expandable member through the head assembly while the expandable member is in the collapsed configuration. In some embodiments, the head assembly includes a central bore defined therein and a lateral opening defined in an outer surface of the head assembly and in communication with the central bore, and advancing the insertion guide through the head assembly comprises advancing the expandable member through the lateral opening and at least partially through the central bore. In some embodiments, moving the expandable member from the collapsed configuration to the expanded configuration includes engaging the distal end face with the expandable member. In some embodiments, the expandable member includes a balloon, and moving the expandable member from the collapsed configuration to the expanded configuration comprises inflating the balloon. In some embodiments, the insertion guide also includes a tube extending from a proximal end of the balloon and in fluid communication with an internal reservoir of the balloon, and inflating the balloon includes delivering a fluid through the tube and into the internal reservoir.

In some embodiments, the head assembly has a first outer diameter, the expandable member has a second outer diameter when the expandable member is in the collapsed configuration, the expandable member has a third outer diameter when the expandable member is in the expanded configuration, the second outer diameter is less than the first outer diameter, and the third outer diameter is equal to or greater than the first outer diameter. In some embodiments, the first tubular tissue segment includes an upper colon segment, the second tubular tissue segment includes a lower colon segment, and inserting the expandable member and the head assembly into the patient includes inserting the expandable member and the head assembly through an anus of the patient while the expandable member is in the expanded configuration. In some embodiments, the method also includes advancing the expandable member and the head assembly through a rectum of the patient while the expandable member is in the expanded configuration.

These and other aspects and embodiments of the present disclosure will be apparent or will become apparent to one of ordinary skill in the art upon review of the following detailed description when taken in conjunction with the drawings and the appended claims.

DETAILED DESCRIPTION

Improved surgical staplers and methods have been developed for performing an end-to-end anastomosis between two tubular tissue segments, such as colon segments following resection of a portion of the colon. Such surgical staplers and methods advantageously may ease insertion and advancement of a head assembly of a stapler to a desired location for performing an anastomosis, while reducing incidence of injury to the surrounding anatomy and corresponding complications for the patient. In particular, the surgical staplers described herein may include an insertion guide having an atraumatic expandable member, such as a balloon, that is configured to be positioned about a distal end of the head assembly. The expandable member may be moved, or transitioned, from a collapsed configuration to an expanded configuration prior to introduction of the stapler into the patient. While in the expanded configuration, the expandable member may cover a distal end face of the head assembly, thereby inhibiting the distal end face from engaging the surrounding anatomy as the head assembly is advanced toward a desired location within a tissue segment. Once the expandable member reaches the desired location, the expandable member may be moved, or transitioned, from the expanded configuration to the collapsed configuration, and the insertion guide may be withdrawn from the head assembly and removed from the patient.

As compared to existing staplers for performing an end-to-end anastomosis, the surgical staplers described herein may allow clinicians to more easily and efficiently introduce a stapler into a patient in a manner that inhibits injury to the surrounding anatomy. For example, in the context of rejoining an upper colon segment and a lower colon segment following resection of a portion of the colon, the atraumatic expandable member of the insertion guide may ease insertion of the head assembly through the anus and advancement of the head assembly through the rectum to the closed end of the lower colon segment. In particular, the expandable member may engage portions of the surrounding anatomy instead of the head assembly, and the curved shape and flexible nature of the expandable member may facilitate advancement of the head assembly through restricted regions and contours of the anatomy without causing injury to the patient. As a result, the surgical staplers described herein may reduce incidence of anal sphincter injury and/or damage to the internal lining of the colon, as may be experienced during use of existing surgical staplers. Further, the surgical staplers described herein may obviate the clinical practice of removing a larger portion of the colon than is needed for the purpose of easing insertion and positioning of the stapler.

Surgical Staplers

FIGS. 1A-1Gillustrate a surgical stapler100(which also may be referred to as an “circular stapler” or simply a “stapler”) configured to perform an end-to-end anastomosis between two tubular tissue segments of a patient, in accordance with one or more embodiments of the disclosure. For example, the surgical stapler100may be used following resection of a portion of a patient's colon to reconnect upper and lower colon segments, as described below with respect toFIGS. 2A-2H. As shown inFIG. 1A, the surgical stapler100includes a tubular shaft110, a handle112, a head assembly114, a trocar116, an anvil118, and an insertion guide120. During use of the surgical stapler100, the head assembly114and a portion of the tubular shaft110may be inserted into a patient, while the handle112remains outside of the patient to allow a clinician to control operation of the stapler100. As described below, the insertion guide120may be used to facilitate insertion of the head assembly114into the patient and to guide advancement of the head assembly114to a target location for performing an anastomosis. Once the head assembly114is positioned at or near the target location, the insertion guide120may be removed from the patient, and the head assembly114, the trocar116, and the anvil118then may be used in a conventional manner to connect two tubular tissue segments via a circular array of staples.

The tubular shaft110may be formed as elongated hollow member having a proximal end and a distal end. As shown, the handle112may extend from the proximal end of the tubular shaft110, and the head assembly114may extend from the distal end of the tubular shaft110. In some embodiments, the handle112and the head assembly114may be fixedly attached to the tubular shaft110. In other embodiments, the handle112and/or the head assembly114may be removably attached to the tubular shaft110. As shown, the tubular shaft110may have a contoured shape including one or more curved regions and one or more straight regions. Alternatively, the tubular shaft110may have a straight shape extending from the proximal end to the distal end thereof. As described below, various internal components of the surgical stapler100may be positioned within or extend through the lumen of the tubular shaft110to allow components of the head assembly114to be controlled by the clinician from outside of the patient during use of the stapler100. It will be appreciated that the illustrated tubular shaft110is merely one example embodiment, and that other shapes and configurations of the tubular shaft110may be used with the surgical stapler100.

The handle112may be formed as an elongated member extending proximally from the proximal end of the tubular shaft110. As shown, the handle112may have a contoured shape to allow the clinician to easily grasp the handle112and move the surgical stapler100relative to the patient. In some embodiments, a portion or all of the handle112may be formed as a hollow member defining an interior space for containing various internal components of the surgical stapler100therein. It will be appreciated that the illustrated handle112is merely one example embodiment, and that other shapes and configurations of the handle112may be used with the surgical stapler100.

The head assembly114may be formed as an elongated assembly extending distally from the distal end of the tubular shaft110. As shown, the head assembly114may include an outer shell122that is attached to a distal end portion of the tubular shaft110and configured to contain other components of the head assembly114therein. The outer shell122may be formed as a substantially hollow member including a central bore124defined therein. The central bore124may extend from a distal end toward a proximal end of the outer shell122. In this manner, the central bore124may be in communication with the lumen of the tubular shaft110to allow various components of the surgical stapler100to extend through the tubular shaft110and the head assembly114. As shown, the outer shell122also may include a lateral opening126that is defined in an outer surface of the outer shell122and in communication with the central bore124. In other words, the lateral opening126may extend from the outer surface of the outer shell122to the central bore124. As described below, the lateral opening126may allow the insertion guide120to pass through the lateral opening126and into the central bore124during use of the insertion guide120.

The head assembly114may include one or more components to facilitate formation of a circular array of staples to connect two tubular tissue segments. For example, the head assembly114may include a staple guide128and a staple pusher130. The staple guide128may be fixedly positioned within the central bore124of the outer shell122. As shown, the staple guide128may extend to the distal end of the outer shell122. In this manner, the distal end of the staple guide128and the distal end of the outer shell122may define a distal end face132of the head assembly114. The distal end face132may be a planar or substantially planar surface extending transverse to, such as perpendicular to, the longitudinal axis of the head assembly114. As shown, the staple guide128may be formed as a ring-shaped member having a plurality of slots134defined therein and a central aperture extending through the staple guide128. The slots134may be arranged in a circular array, and each slot134may be configured to receive a respective staple therein. In this manner, the slots134of the staple guide128may maintain the plurality of staples in respective positions around the longitudinal axis of the head assembly114to facilitate formation of a circular array of staples for joining the tubular tissue segments. The staple pusher130may be movably positioned within the central bore124of the outer shell122. For example, the staple pusher130may be configured to translate relative to the outer shell122along the longitudinal axis of the head assembly114between a retracted position and an extended position. As shown, the staple pusher130may be positioned axially between the staple guide128and the outer shell122. The staple pusher130may include a base portion and a plurality of protrusions extending distally from the base portion and corresponding to the slots134of the staple guide128. When the staple pusher130moves from the retracted position to the extended position, the protrusions of the staple pusher130may engage the respective slots134and cause the staples to be ejected therefrom. In some embodiments, the staple pusher130may include an aperture that is aligned with the lateral opening126of the outer shell122when the staple pusher130is in the retracted position. In this manner, the insertion guide120may pass through the lateral opening126, through the aperture of the staple pusher130, and into the central bore124during use of the insertion guide120.

The head assembly114also may include one or more components for coring respective portions of the tubular tissue segments being connected to one another. For example, the head assembly114may include a circular knife136. The circular knife136may be movably positioned within the central bore124of the outer shell122. For example, the circular knife136may be configured to translate relative to the outer shell122along the longitudinal axis of the head assembly114between a retracted position and an extended position. The circular knife136may be formed as a tubular member having a cutting edge along the distal end of the circular knife136and a central aperture extending through the circular knife136. In some embodiments, the circular knife136may be fixedly attached to the staple pusher130. In this manner, the circular knife136may move along with the staple pusher130between the retracted position and the extended position. When the circular knife136is in the extended position, the cutting edge thereof may extend distally beyond the staple guide128to engage and cut radially inner portions of the tubular tissue segments. It will be appreciated that the illustrated head assembly114is merely one example embodiment, and that other shapes and configurations of the head assembly114may be used with the surgical stapler100.

The trocar116may be formed as an elongated member extending along the longitudinal axis of the head assembly114. The trocar116movably positioned within the tubular shaft110and/or the head assembly114. For example, the trocar116may be configured to translate relative to the outer shell122along the longitudinal axis of the head assembly114between a retracted position, as shown inFIG. 1B, and an extended position, as shown inFIGS. 1A and 1C. When the trocar116is in the retracted position, a proximal portion of the trocar116may be positioned within the tubular shaft110, and a distal portion of the trocar116may be positioned within the head assembly114. When the trocar116is in the extended position, a proximal portion of the trocar116may be positioned within the head assembly114, and a distal portion of the trocar116may extend distally beyond the distal end of the head assembly114. As shown, the trocar116may include a distal tip138configured to penetrate tissue during use of the surgical stapler100, as described below. The trocar116also may include a protrusion140extending along the outer circumference of an intermediate portion of the trocar116and configured to facilitate attachment of the anvil118to the trocar116during use of the surgical stapler100. It will be appreciated that the illustrated trocar116is merely one example embodiment, and that other shapes and configurations of the trocar116may be used with the surgical stapler100.

The anvil118may be formed as an elongated assembly configured for attachment to the trocar116. As shown, the anvil118may include an anvil shaft142and an anvil head144attached to one another. In some embodiments, the anvil head144may be fixedly attached to the anvil shaft142, with the anvil head144extending perpendicular to the longitudinal axis of the anvil shaft142. In other embodiments, the anvil head144may be pivotably attached to the anvil shaft142, such that the orientation of the anvil head144relative to the longitudinal axis of the anvil shaft142may be adjusted, for example, to ease insertion of the anvil head144into or removal of the anvil head144from a tubular tissue segment. The anvil shaft142may include a central passage146for receiving a distal portion of the trocar116therein, as shown inFIG. 1D. The anvil shaft142also may include a groove148extending along the inner circumference of the central passage146and configured to receive the protrusion140of the trocar116therein as well as one or more elongated slots150to facilitate a snap-fit connection between the anvil shaft142and the trocar116. During use of the surgical stapler100, the anvil118may be attached to the trocar116and then moved relative to the head assembly114from an extended position, as shown inFIG. 1D, to a retracted position, as shown inFIG. 1E. In this manner, the movement of the trocar116from its extended position to its retracted position may move the anvil118from its extended position to its retracted position. When the anvil118is in the retracted position, the anvil head144may be positioned adjacent to or near the distal end of the head assembly114. In this manner, the anvil head144may facilitate desired deformation of the staples when the staples are ejected from the staple guide128and the free ends of the staples engage the anvil head144. Additionally, the anvil head144may facilitate coring of the radially inner portions of the tissue segments when the circular knife136passes through the tissue segments and engages the anvil head144. It will be appreciated that the illustrated anvil118is merely one example embodiment, and that other shapes and configurations of the anvil118may be used with the surgical stapler100.

The surgical stapler100may include one or more components configured to allow the clinician to control movement of the trocar116and the anvil118relative to the head assembly114from outside of the patient during use of the stapler100. For example, the surgical stapler100may include a knob152that is attached to the handle112and coupled to the trocar116. The knob152may be rotatably attached to the handle112such that the knob152is configured to rotate about the longitudinal axis of the handle112. The knob152may be mechanically coupled to the trocar116such that rotation of the knob152in a first direction (e.g., counter-clockwise) causes the trocar116to move distally relative to the head assembly114and rotation of the knob152in an opposite second direction (e.g., clockwise) causes the trocar116to move proximally relative to the head assembly114. Various types of components may be used to mechanically couple the knob152to the trocar116in this manner, such as one or more threaded members, geared members, cams, couplings, and/or other mechanical components. It will be appreciated that such components may be positioned within respective portions of the tubular shaft110, the handle112, and/or the head assembly114.

The surgical stapler100also may include one or more components configured to allow the clinician to control movement of the staple pusher130and the circular knife136relative to the outer shell122and the staple guide128from outside of the patient during use of the stapler100. For example, the surgical stapler100may include a lever154that is attached to the handle112and coupled to the staple pusher130. The lever154may be pivotably attached to the handle112such that the lever154is configured to pivot relative to the handle112. The lever154may be mechanically coupled to the staple pusher130such that pivotal movement of the lever154in a first direction (e.g., toward the handle112) causes the staple pusher130to move distally relative to the outer shell122and the staple guide128and pivotal movement of the lever154in an opposite second direction (e.g., away from the handle112) causes the staple pusher130to move proximally relative to the outer shell122and the staple guide128. Various types of components may be used to mechanically couple the lever154to the staple pusher130in this manner, such as one or more threaded members, geared members, cams, couplings, and/or other mechanical components. It will be appreciated that such components may be positioned within respective portions of the tubular shaft110, the handle112, and/or the head assembly114.

The insertion guide120may be formed as an elongated assembly configured for engaging the head assembly114. As shown, the insertion guide120may include an expandable member162, a tube164, a port166, and a distal tip168. The expandable member162may be configured to move or be transitioned between a collapsed configuration, as shown inFIG. 1F, and an expanded configuration, as shown inFIGS. 1A and 1G. For example, the expandable member162may be configured to radially expand and collapse about the longitudinal axis of the expandable member162between the collapsed configuration and the expanded configuration. In some embodiments, as shown, the expandable member162may be an inflatable atraumatic balloon that is formed of a flexible, elastomeric material, e.g., silicone, polyurethane, etc. In this manner, the expandable member162may include an internal reservoir170that is configured to receive a fluid, such as air, water, or saline, to facilitate expansion of the expandable member162from the collapsed configuration to the expanded configuration. In some embodiments, the expandable member162expands by elastic deformation upon being filled with the fluid. As shown, the expandable member162may have a curved outer surface when the expandable member162is in the expanded configuration. In this manner, when the expandable member162is in the expanded configuration, the curved outer surface may facilitate insertion of the expandable member162into the patient and advancement of the expandable member162through surrounding anatomy and to a target location within the patient, without causing injury to the patient. According to various embodiments, the expandable member162may have a spherical shape, an egg shape, a toroidal shape, or other shape having a curved outer surface when the expandable member162is in the expanded configuration. It will be appreciated that the illustrated expandable member162is merely one example embodiment, and that other shapes and configurations of the expandable member162may be used with the surgical stapler100.

The tube164of the insertion guide120may be formed as an elongated, hollow member extending from the proximal end of the expandable member162. The tube164may be fixedly attached to the expandable member162. In some embodiments, as shown, a distal portion of the tube164may be positioned within the expandable member162. The tube164may include an internal lumen172that extends from the proximal end of the tube164toward the distal end of the tube164and is in fluid communication with the internal reservoir170of the expandable member162. For example, the lumen172may terminate at an opening174that is defined in a sidewall of the tube164and provides fluid communication between the lumen172and the internal reservoir170of the expandable member162. In this manner, a fluid may be delivered through the lumen172and into the internal reservoir170to facilitate expansion of the expandable member162from the collapsed configuration to the expanded configuration. Similarly, the fluid may be subsequently released from the internal reservoir170and through the lumen172to facilitate contraction of the expandable member162from the expanded configuration to the collapsed configuration. In some embodiments, the tube164may be formed of a flexible material configured to allow the shape of the tube164to be manipulated during use of the insertion guide120. In other embodiments, the tube164may be formed of a rigid or substantially rigid material configured to maintain a predetermined shape of the tube164during use. It will be appreciated that the illustrated tube164is merely one example embodiment, and that other shapes and configurations of the tube164may be used with the surgical stapler100.

The port166of the insertion guide120may be fixedly attached to the proximal end of the tube164and configured to facilitate attachment of a fluid delivery device, such as a syringe. In this manner, the fluid delivery device may be used to deliver the fluid through the tube164and into the expandable member162or to withdraw the fluid from the expandable member162and the tube164. In some embodiments, the port166may include a luer lock connection or other type of connection for attaching the fluid delivery device thereto. It will be appreciated that the illustrated port166is merely one example embodiment, and that other shapes and configurations of the port166may be used with the surgical stapler100.

The distal tip168of the insertion guide120may be formed as a non-expandable, elongated member extending from the distal end of the expandable member162. The distal tip168may be fixedly attached to the expandable member162. In some embodiments, as shown, a proximal portion of the distal tip168may be positioned within the expandable member162. In some embodiments, the distal tip168may be hollow. In other embodiments, the distal tip168may be solid. In some embodiments, the distal tip168may be formed of a flexible material configured to allow the distal tip168to elastically deform as the distal tip168engages surrounding anatomy of the patient during use of the insertion guide120. In other embodiments, the distal tip168may be formed of a rigid or substantially rigid material configured to maintain a predetermined shape of the distal tip168during use. It will be appreciated that the illustrated distal tip168is merely one example embodiment, and that other shapes and configurations of the distal tip168may be used with the surgical stapler100. In some embodiments, the distal tip168may be omitted, such that the distal end of the expandable member162defines the distal end of the insertion guide120.

In some embodiments, as shown inFIGS. 1F and 1G, the insertion guide120may be inserted through the head assembly114of the surgical stapler100. In particular, the insertion guide120may be inserted through the head assembly114such that a distal portion of the insertion guide120extends distally beyond the distal end face132of the head assembly114, a proximal portion of the insertion guide120extends proximally from the head assembly114, and an intermediate portion of the insertion guide120is positioned within the head assembly114. As shown inFIG. 1F, the insertion guide120may be advanced through the head assembly114while the expandable member162is in the collapsed configuration. Similarly, the insertion guide120may be removed from the head assembly114while the expandable member162is in the collapsed configuration. As described above, the insertion guide120may extend through the lateral opening126of the head assembly114, through the central bore124of the head assembly114, and distally beyond the distal end face132of the head assembly114. In this manner, the insertion guide120also may extend through the central aperture of the staple guide128, through the opening of the staple pusher130, and through the central aperture of the circular knife136. As shown, the head assembly114may have a first outer diameter OD1and the expandable member162may have a second outer diameter OD2when the expandable member162is in the collapsed configuration, with the second outer diameter OD2being less than the first outer diameter OD1.

After inserting the insertion guide120through the head assembly114, the expandable member162may be moved from the collapsed configuration to the expanded configuration, as shown inFIG. 1G. In some embodiments, the expandable member162may engage the distal end face132of the head assembly114when the expandable member162is in the expanded configuration. In some embodiments, a proximal portion of the expandable member162may be positioned within the central bore124of the head assembly114when the expandable member162is in the expanded configuration. In this manner, the proximal portion of the expandable member162may assist in self-centering the expandable member162relative to the longitudinal axis of the head assembly114when the expandable member162is moved from the collapsed configuration to the expanded configuration. In other embodiments, the entirety of the expandable member162may be positioned outside of the central bore124of the head assembly114and distally beyond the distal end face132when the expandable member162is in the expanded configuration. As shown, the expandable member162may have a third outer diameter OD3when the expandable member162is in the expanded configuration. In some embodiments, the third outer diameter OD3may be greater than the first outer diameter OD1of the head assembly114. In other embodiments, the third outer diameter OD3may be equal to the first outer diameter OD1of the head assembly114.

In some embodiments, as shown inFIGS. 1H and 1I, the insertion guide120may be inserted through the tubular shaft110and the head assembly114of the surgical stapler100. In particular, the insertion guide120may be inserted through the tubular shaft110and the head assembly114such that a distal portion of the insertion guide120extends distally beyond the distal end face132of the head assembly114, a proximal portion of the insertion guide120extends proximally from the tubular shaft110, and an intermediate portion of the insertion guide120is positioned within the tubular shaft110and the head assembly114. In some embodiments, the insertion guide120may extend through the lumen of the tubular shaft110along with other internal components of the surgical stapler100. In some embodiments, the tubular shaft110may include a dedicated tube, passage, or channel positioned within the lumen of the tubular shaft110and configured to receive the insertion guide120therethrough. In this manner, the tubular shaft110may have a predefined pathway for allowing the insertion guide120to extend therethrough and to shield the insertion guide120from other internal components within the tubular shaft110. As shown inFIG. 1H, the insertion guide120may be advanced through the tubular shaft110and the head assembly114while the expandable member162is in the collapsed configuration. Similarly, the insertion guide120may be removed from the tubular shaft110and the head assembly114while the expandable member162is in the collapsed configuration. In some embodiments, the insertion guide120may extend through a lateral opening126′ of the handle112, through a portion of the internal space of the handle112, through the lumen of the tubular shaft110, through the central bore124of the head assembly114, and distally beyond the distal end face132of the head assembly114. In this manner, the insertion guide120also may extend through the central aperture of the staple guide128, through an opening of the staple pusher130, and through the central aperture of the circular knife136. As shown, the head assembly114may have a first outer diameter OD1and the expandable member162may have a second outer diameter OD2when the expandable member162is in the collapsed configuration, with the second outer diameter OD2being less than the first outer diameter OD1.

After inserting the insertion guide120through the tubular shaft110and the head assembly114, the expandable member162may be moved from the collapsed configuration to the expanded configuration, as shown inFIG. 1I. In some embodiments, the expandable member162may engage the distal end face132of the head assembly114when the expandable member162is in the expanded configuration. In some embodiments, a proximal portion of the expandable member162may be positioned within the central bore124of the head assembly114when the expandable member162is in the expanded configuration. In this manner, the proximal portion of the expandable member162may assist in self-centering the expandable member162relative to the longitudinal axis of the head assembly114when the expandable member162is moved from the collapsed configuration to the expanded configuration. In other embodiments, the entirety of the expandable member162may be positioned outside of the central bore124of the head assembly114and distally beyond the distal end face132when the expandable member162is in the expanded configuration. As shown, the expandable member162may have a third outer diameter OD3when the expandable member162is in the expanded configuration. In some embodiments, the third outer diameter OD3may be greater than the first outer diameter OD1of the head assembly114. In other embodiments, the third outer diameter OD3may be equal to the first outer diameter OD1of the head assembly114.

In some embodiments, the surgical stapler100may include both the lateral opening126of the head assembly114and the lateral opening126′ of the handle112, as shown inFIG. 1A. In this manner, the clinician may have the option of using the lateral opening126of the head assembly114to extend the insertion guide120through only the head assembly114, as described above with respect toFIGS. 1F and 1G, or using the lateral opening126′ of the handle112to extend the insertion guide120through both the tubular shaft110and the head assembly114, as described above with respect toFIGS. 1H and 1I. In other embodiments, the lateral opening126of the head assembly114or the lateral opening126′ of the handle112may be omitted.

Methods of Use

FIGS. 2A-2Hillustrate an example method of using the surgical stapler100to perform an end-to-end anastomosis between two tissue segments of a tubular tissue structure of a patient, in accordance with one or more embodiments of the disclosure.FIG. 2Ashows a tubular tissue structure200of a patient, which includes a first tissue segment202, a second tissue segment204, and an intermediate portion206of the tubular tissue structure200to be removed from the patient. In some embodiments, the tubular tissue structure200may be a colon of the patient, the first tissue segment202may be an upper colon segment, and the second tissue segment204may be a lower colon segment. Following resection of the intermediate portion206, the first tissue segment202and the second tissue segment204may need to be reconnected to one another by performing an end-to-end anastomosis to restore the natural function of the tubular tissue structure200.

The anastomosis procedure may begin by inserting the anvil head144of the anvil118into the first tissue segment202and securing the free end of the first tissue segment202around the anvil shaft142of the anvil118, as shown inFIG. 2B. In this manner, the anvil shaft142may extend outside of the first tissue segment202, while the anvil head144is maintained within the first tissue segment202. In some embodiments, the free end of the first tissue segment202may be secured around the anvil shaft142by suturing the tissue, for example, to form a purse-string suture208. Meanwhile, the free end of the second tissue segment204may be closed by suturing the tissue, for example, to form a linear suture210, as shown inFIG. 2B.

After closing the free end of the second tissue segment204, the head assembly114of the surgical stapler100may be inserted into the patient and advanced toward the closed end of the second tissue segment204. As described above, the insertion guide120may be used to facilitate insertion of the head assembly114and advancement of the head assembly114to the closed end of the second tissue segment204. In particular, the insertion guide120may be inserted through the head assembly114, as described above with respect toFIG. 1F, and the expandable member162may be moved from the collapsed configuration to the expanded configuration, as described above with respect toFIG. 1G. Alternatively, the insertion guide120may be inserted through the tubular shaft110and the head assembly114, as described above with respect toFIG. 1H, and the expandable member162may be moved from the collapsed configuration to the expanded configuration, as described above with respect toFIG. 1I. For example, the expandable member162may be expanded to the expanded configuration by delivering a fluid through the tube164and into the internal reservoir170of the expandable member162via a fluid delivery device attached to the port166. The insertion guide120and the head assembly114then may be inserted into the patient and advanced through the surrounding anatomy until the expandable member162and the head assembly114are positioned adjacent to the closed end of the second tissue segment204, as shown inFIG. 2C. Meanwhile, the port166and the fluid delivery device may remain positioned outside of the patient. In embodiments in which the tubular tissue structure200is the colon of the patient and the second tissue segment204is the lower colon segment, the expandable member162may ease insertion of the head assembly114through the anus, through the contours of the rectum, and through the lower colon segment, while inhibiting the distal end face132of the head assembly114from engaging the surrounding anatomy.

After the expandable member162and the head assembly114are positioned adjacent to the closed end of the second tissue segment204, the expandable member162may be moved from the expanded configuration to the collapsed configuration. For example, the fluid delivery device may be used to withdraw the fluid from the internal reservoir170of the expandable member162, thereby causing the expandable member162to assume the collapsed configuration. The insertion guide120then may be withdrawn proximally from the head assembly114and removed from the patient. After removal of the insertion guide120from the head assembly114, the head assembly114may be further advanced to a position adjacent to the closed end of the second tissue segment204, as shown inFIG. 2D.

With the head assembly114positioned adjacent to the closed end of the second tissue segment204, the trocar116may be passed through the closed end of the second tissue segment204, as shown inFIG. 2E. For example, the knob152of the surgical stapler100may be rotated counter-clockwise to cause the trocar116to move from the retracted position to the extended position. In this manner, the trocar116may be advanced through the closed end of the second tissue segment204and extend into the space between the first tissue segment202and the second tissue segment204.

The anvil118and the trocar116then may be attached to one another, as shown inFIG. 2F. For example, the anvil118and/or the trocar116may be grasped via one or more surgical instruments, such as forceps, and moved relative to one another such that the anvil118is advanced over the trocar116and secured thereto by the connection between the protrusion140and the groove148.

After attaching the anvil118to the trocar116, the anvil118and the trocar116may be moved from the extended position to the retracted position, as shown inFIG. 2G. For example, the knob152of the surgical stapler100may be rotated clockwise to cause the trocar116and the anvil118to move from the extended position to the retracted position. In this manner, the respective ends of the first tissue segment202and the second tissue segment204may be drawn together and captured between the anvil head144and the distal end face132of the head assembly114. The head assembly114then may be actuated to facilitate formation of a circular array of staples through the respective end portions of the first tissue segment202and the second tissue segment204and to core respective inner portions of the first tissue segment202and the second tissue segment204. For example, the lever154of the surgical stapler100may be moved relative to the handle112to actuate the head assembly114. The actuation of the head assembly114may cause the staple pusher130and the circular knife136to move distally relative to the outer shell122and the staple guide128. As described above, the movement of the staple pusher130may cause the staples to be ejected from the staple guide128, advanced through the respective end portions of the first tissue segment202and the second tissue segment204, and deformed against the anvil head144. In this manner, a circular array of staples212may be formed to reconnect the first tissue segment202and the second tissue segment204. Meanwhile, the movement of the circular knife136may cause the cutting edge thereof to cut the respective inner portions of the first tissue segment202and the second tissue segment204against the anvil head144. In this manner, fluid communication between the first tissue segment202and the second tissue segment204may be restored. After actuating the head assembly114, the surgical stapler100may be removed from the patient, leaving the first tissue segment202and the second tissue segment204reconnected by an end-to-end anastomosis, as shown inFIG. 2H.

Modifications and variations of the devices, systems, and methods described herein will be obvious to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to come within the scope of the appended claims.