Surgical stapling device with firing lockout mechanism

A surgical stapling device includes a tool assembly including an anvil and a cartridge assembly that are movable in relation to each other between open and clamped positions. The cartridge assembly includes a staple cartridge that can be replaced after each firing of the stapling device to facilitate reuse of the stapling device. The anvil includes a lockout mechanism that prevents operation of the stapling device when the staple cartridge has been previously fired. The lockout mechanism is adapted to move from a locked position to an unlocked position when the staple cartridge is replaced and the tool assembly is moved from the open position to the clamped position.

FIELD

The disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices with lockout mechanisms to prevent firing of the stapling device with a spent staple cartridge.

BACKGROUND

Surgical stapling devices for simultaneously stapling and cutting tissue are well known in the art. Typically, these stapling devices include a tool assembly and a drive assembly. The tool assembly includes an anvil assembly and a cartridge assembly having a staple cartridge including a knife and an actuation sled. The drive assembly is movable in relation to the anvil and cartridge assemblies to move the tool assembly between open and clamped positions and to advance the knife and actuation sled to eject staples from the staple cartridge and cut tissue clamped between the anvil and cartridge assemblies. After the stapling device is fired, the actuation sled remains in an advanced position within the tool assembly.

In some stapling devices, the staple cartridge is received within a channel member of the cartridge assembly and is replaceable to facilitate reuse of the stapling device. In order to prevent advancement of the knife of the tool assembly after the staples have been fired from the staple cartridge, the tool assembly may include a lockout assembly. The lockout assembly is movable from an unlocked position to a locked position into engagement with the drive assembly when the sled is in its advanced position to prevent readvancement of the drive assembly. In some stapling devices, the lockout assembly is movable to the unlocked position in response to insertion of a new staple cartridge into the channel member.

A continuing need exists for a lock mechanism of simple construction that can prevent advancement of a drive assembly of a stapling device when a spent staple cartridge is positioned within the channel member of the cartridge assembly.

SUMMARY

This disclosure is directed to a surgical stapling device having a tool assembly that includes an anvil and a cartridge assembly that are movable in relation to each other between open and clamped positions. The cartridge assembly includes a staple cartridge that can be replaced after each firing of the stapling device to facilitate reuse of the stapling device. The anvil includes a lockout mechanism that prevents operation of the stapling device when the staple cartridge has been previously fired. The lockout mechanism moves from a locked position to an unlocked position when the staple cartridge is replaced and the tool assembly is moved from the open position to the clamped position.

One aspect of the disclosure is directed to a surgical stapling device including an elongate body, a tool assembly, a lock mechanism, and a drive assembly. The elongate body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongate body and includes an anvil and a cartridge assembly. The cartridge assembly includes a channel member and a staple cartridge that is removably received within the channel member. The staple cartridge includes a cartridge body, staples, and an actuation sled assembly including an actuation sled and a knife supported on the actuation sled. The actuation sled assembly is movable through the cartridge body between retracted and advanced positions. The anvil includes an anvil body and is coupled to the cartridge assembly such that the tool assembly is movable between open and clamped positions. The lock mechanism is supported on the anvil and includes a lock member that is movable between a locked position and an unlocked position in response to movement of the tool assembly from the open position to the clamped position. The drive assembly includes a clamp member that is movable in relation to the tool assembly between retracted and advanced positions. The lock member is positioned to prevent movement of the clamp member from the retracted position to the advanced position in the locked position.

Another aspect of the disclosure is directed to an anvil assembly that includes an anvil and a lock mechanism. The anvil includes an anvil body having a staple forming surface that defines a plurality of staple forming pockets and a central knife slot. The staple forming pockets are positioned on opposite sides of the central knife slot. The lock mechanism is supported on the anvil body and includes a lock member that is movable between a locked position and an unlocked position.

In aspects of the disclosure, the lock member is biased to the locked position.

In some aspects of the disclosure, the lock member engages the actuation sled assembly when the actuation sled assembly is in its retracted position to retain the lock member in the unlocked position.

In certain aspects of the disclosure, the lock mechanism includes a pivot member that pivotably secures the lock member to the anvil body.

In aspects of the disclosure, the lock mechanism includes a biasing member for urging the lock member towards the locked position.

In some aspects of the disclosure, the biasing member includes a torsion spring.

In certain aspects of the disclosure, the lock mechanism includes a dowel that extends through the anvil body and engages the lock member to prevent outward movement of the lock member.

In aspects of the disclosure, the lock member is secured to the anvil body in cantilevered fashion and includes a resilient arm that is deformable to move the lock member from the locked position to the unlocked position.

In some aspects of the disclosure, the lock mechanism includes a biasing mechanism that is supported on the anvil body and is positioned to urge the arm of the lock member towards the locked position.

In certain aspects of the disclosure, the biasing mechanism includes a post and a coil spring that is positioned about the post and is engaged with the arm of the lock member to urge the lock member towards the locked position.

In aspects of the disclosure, the lock mechanism includes a lock plate and the lock member, and the anvil body defines first and second through bores.

In some aspects of the disclosure, the lock plate includes a clevis and a guide member, and the clevis extends through the first through bore and is pivotably coupled to the lock member and the guide member extends through the second through bore.

In certain aspects of the disclosure, the lock member is pivotable between the locked and unlocked positions.

In aspects of the disclosure, the anvil body includes an outer surface that defines a recess and the lock plate is received within the recess and is movable between raised and lowered positions.

In some aspects of the disclosure, the raised position corresponds to the locked position of the lock member and the lowered position corresponds to the unlocked position of the lock plate.

In certain aspects of the disclosure, the lock mechanism includes a first biasing member that is positioned to urge the lock plate towards the lowered position.

In aspects of the disclosure, the lock mechanism includes a second biasing member that is positioned to urge the lock member towards the locked position.

Other features of the disclosure will be appreciated from the following description.

DETAILED DESCRIPTION

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

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

The disclosed surgical stapling device includes a tool assembly and a drive assembly for actuating the tool assembly. The tool assembly includes an anvil and a cartridge assembly that are movable in relation to each other between open and clamped positions. The cartridge assembly includes a channel member and a staple cartridge that is releasably received within the channel member and replaceable to facilitate reuse of the stapling device. The staple cartridge includes a clamp member, a knife, and an actuation sled that are movable through a body of the staple cartridge in response to movement of the drive assembly from a retracted position to an advanced position to move the tool assembly from the open position to the clamped position, to eject staples from the staple cartridge, and to cut tissue clamped between the anvil and the cartridge assembly. The anvil supports a lock mechanism that is movable from a locked position to an unlocked position in response to movement of the tool assembly from the open position to the clamped position. In the locked position, the lock mechanism obstructs movement of the drive assembly from its retracted to its advanced position to prevent operation of the stapling device. In the unlocked position, the lock mechanism is positioned to allow the drive assembly to move from the retracted position to the advanced position to operate the stapling device.

FIGS.1-3illustrate a surgical stapling device according to aspects of the disclosure shown generally as stapling device10which includes a handle assembly12, an elongate body14, and a tool assembly100. The elongate body14defines a longitudinal axis “X”. The handle assembly12includes a body18that defines a hand grip18a, a plurality of actuator buttons20, a rotation knob22, and an articulation lever24. The rotation knob22is rotatably supported on a distal portion of the body18of the handle assembly12and supports the elongate body14to facilitate rotation of the elongate body14and the tool assembly100in relation to the handle assembly12about the longitudinal axis “X”. The actuator buttons20control operation of the various functions of the stapling device10including approximation, firing and cutting. The articulation lever24is rotatably supported on the rotation knob22and is pivotable to effect articulation of the tool assembly100in relation to the elongate body14about an axis transverse to the longitudinal axis “X” of the elongate body14. Although the stapling device10is illustrated as an electrically powered stapling device, it is envisioned that the disclosed tool assembly100would also be suitable for use with manually powered surgical stapling devices or with a robotic system for robotically controlling a stapling device. U.S. Pat. No. 9,055,943 discloses a surgical stapling device including a powered handle assembly and U.S. Pat. No. 6,241,139 discloses a surgical stapling device including a manually actuated handle assembly. U.S. Pat. No. 9,962,159 discloses a stapling device that is configured for use with a robotic system.

FIGS.2and3illustrate the tool assembly100which includes an anvil102and a cartridge assembly104. The cartridge assembly104includes a staple cartridge106and a channel member108that receives the staple cartridge106. In aspects of the disclosure, the staple cartridge106is releasably supported within the channel member108and is replaceable to facilitate reuse of the tool assembly100. The staple cartridge106includes a cartridge body110, an actuation sled112(FIG.5), and a plurality of staples114(FIG.9). The cartridge body110defines a central knife slot116and staple receiving pockets118. In aspects of the disclosure, the staple receiving pockets118are aligned in rows positioned on each side of the central knife slot116. Although three rows of staple receiving pockets118on each side of the central knife slot116are shown inFIG.2, it is envisioned that the cartridge body110may define one or more rows of staple receiving pockets118on each side of the central knife slot116. Each of the staple receiving pockets118receives a staple114. Although not shown, the staple cartridge104also includes pushers that support the staples114and are engaged by the actuation sled112(FIG.5) as the actuation sled112is advanced through the cartridge body110to eject the staples114from the cartridge body110. More specifically, the actuation sled112includes angled cam surfaces112a(FIG.5) that engage and lift the pushers within the cartridge body110of the staple cartridge104to eject the staples114from the cartridge body110.

FIGS.4-7illustrate the actuation sled112of the staple cartridge106. In aspects of the disclosure, the actuation sled112supports a knife120to form an assembly that is movable through the cartridge body110from a retracted position to an advanced position. The knife120includes a longitudinal body portion122and a vertically positioned cutting member124that extends from the body122through the central knife slot116in the cartridge body110towards the anvil102.

FIGS.7and8illustrate the anvil102of the tool assembly100which includes an anvil body130that has a proximal portion132and a distal portion134. The distal portion134of the anvil body130has a staple forming surface136that defines staple forming pockets136a. The staple forming surface136is movable into juxtaposed alignment with the staple cartridge106when the tool assembly100is moved from the open position to the clamped position to position the staple forming pockets136ain alignment with the staple receiving pockets118of the staple cartridge106. The anvil body130defines a channel138and a central knife slot140that communicates with the channel138. The channel138has a proximal portion that is defined by ramped surfaces142that are positioned on each side of the central knife slot140. The proximal portion132of the anvil body130includes side flanges144that define openings146. Each of the openings146receives a pivot member148(FIG.3) to pivotably couple the anvil102to the channel member108of the cartridge assembly104.

The stapling device10(FIG.1) includes a drive assembly including a drive screw150(FIG.9) and a clamp member152. As known in the art, the drive screw150is axially fixed but rotatably supported within the cartridge assembly104.

FIGS.4-6illustrate the clamp member152which includes a body154having a first beam156, a second beam158, and a central portion160that interconnects the first beam156and the second beam158. The central portion160includes a vertical strut162and a hub164. The vertical strut162defines a distal stop surface172and has a first end that is secured to the first beam156and a second end that is secured to a first side of the hub164. The hub164has a second side that is connected to the second beam158. The hub164defines a threaded through bore166that receives the drive screw150. When the drive screw150is rotated within the cartridge assembly104, the clamp member152is driven longitudinally along the drive screw150within the staple cartridge106between retracted and advanced positions.

The first beam156is received within the channel138defined within the anvil body130of the anvil102. When the clamp member152moves from its retracted position to its advanced position, the first beam156of the clamp member152engages the ramped surfaces142of the anvil body130to pivot the anvil102in relation to the cartridge assembly104from the open position to the clamped position. The first beam156of the clamp member152includes a distally extending finger156athat has a downwardly extending projection170that slides along the central knife slot140(FIG.7) of the anvil102to push tissue from within the knife slot140.

The second beam158is positioned to move within a channel108a(FIG.11) that extends along the channel member108(FIG.2) of the cartridge assembly104as the clamp member152moves between its retracted and advanced positions. Engagement of the first and second beams156and158with the anvil102and the cartridge assembly104, respectively, sets a maximum tissue gap between the staple forming surface136of the anvil102and the staple cartridge106(FIG.2) as the clamp member152moves through the tool assembly100.

When the staple cartridge106is received within the channel member108of the cartridge assembly104, the clamp member152is positioned proximally of and adjacent to the actuation sled112. In this position, the cutting member124of the knife120is positioned adjacent to the distal stop surface172(FIG.4) of the vertical strut162of the clamp member152.

FIGS.7and8illustrate a lock mechanism180of the tool assembly100which includes a lock member182, a biasing member184, and a pivot member186. The lock member182includes a circular hub portion188, an arm190that extends proximally from the hub portion188, and a central tab189. The central hub189includes an angled side wall189a. The arm190includes a proximal abutment surface192. The hub portion188is pivotably secured within a circular recess194defined in the anvil body130(FIG.8) by the pivot member186such that the lock member182is pivotable about an axis “Z” (FIG.8) that is transverse to the longitudinal axis “X” of the tool assembly100. The biasing member184includes a central hub portion196that is received about the pivot member186and first and second spring arms198and200. The first spring arm198is secured to the lock member182and the second spring arm200is received with the circular recess194of the anvil body130to urge the lock member182to a locked position. In the locked position, the proximal abutment surface192of the lock arm182is axially aligned with the distal stop surface172of the clamp member152to prevent movement of the clamp member152within the tool assembly100from the retracted position towards the advanced position.

A pin or dowel204is inserted through an opening206in the anvil body130. The dowel204defines a flat208that engages the arm190of the lock member182to obstruct outward movement of the lock member182towards the anvil body130of the anvil102.

FIGS.9-11illustrate the tool assembly100in the clamped position with the lock mechanism180in the unlocked position. When a new staple cartridge106, i.e., unfired, is positioned within the channel member108of the cartridge assembly104and the tool assembly100is moved to the clamped position, the staple forming surface136(FIG.8) of the anvil102moves into juxtaposed alignment with the staple cartridge106. The cartridge body110of the staple cartridge106defines a cutout110a(FIG.11) that receives a portion of the lock member182when the tool assembly100is moved to the clamped position. As the anvil102pivots in relation to the staple cartridge106, the angled side wall189a(FIG.11) of the central tab189of the lock member182engages the knife120to urge the lock member182of the lock mechanism180against the urging of the biasing member184from the locked position (FIG.12) to the unlocked position (FIG.9). In the unlocked position, the lock member182is engaged with the knife120and the proximal abutment surface192of the lock arm182is maintained in a position outwardly of the distal stop surface172of the clamp member152. In this position, the stapling device10(FIG.1) can be fired.

FIGS.12-14illustrate the tool assembly100with the lock mechanism180in the locked position. When the stapling device10is fired, the clamp member152is advanced through the tool assembly100from a retracted position to an advanced position. As the clamp member152moves through the tool assembly100, the clamp member152abuts and advances the actuation sled112and the knife120(which is supported on the actuation sled112) through the staple cartridge106. Since the actuation sled112is only in abutting relationship with the clamp member152, when the clamp member152is moved from the advanced position back to the retracted position, the actuation sled112and the knife120remain in the distal end of the staple cartridge106. As such, after the stapling device10(FIG.1) is fired and the clamp member152is returned to the retracted position, the knife120and/or actuation sled112are no longer positioned to obstruct movement of the lock member182of the lock mechanism180from the unlocked position to the locked position. Thus, after the stapling device10(FIG.1) is fired and the clamp member152is retracted, the lock member182is moved by the biasing member184from the unlocked position (FIG.9) to the locked position (FIG.12) in which the proximal abutment surface192of the lock member182is positioned in alignment with the distal stop surface172of the clamp member152to prevent distal movement (or readvancement) of the clamp member152.

FIGS.15-19illustrate a tool assembly300(FIG.18) including an alternate version of the anvil and lock mechanism of the stapling device10(FIG.1) which are shown generally as anvil302and lock mechanism380. The anvil302is substantially like the anvil102(FIG.7) except that the anvil302defines a cutout304and a through bore306. The anvil302includes side flanges344. The lock mechanism380includes a lock member382and a securement member386. In aspects of the disclosure, the securement member386includes a screw although other securement members are envisioned. The lock member382has a resilient arm390that includes a proximal portion390aand a distal portion390b. The proximal portion390adefines a bore392and the distal portion390bincludes an abutment member394that has an abutment surface394a. The proximal portion390aof the lock member382is secured to an inner wall of one of the side flanges344of the anvil302in cantilevered fashion by inserting the screw386through the through bore306in the side flange344of the anvil302and the through the bore392in the proximal portion390aof the lock member382and securing the screw386to an inner surface of the anvil302. The arm390includes a central portion390cof reduced thickness that allows the arm390to flex outward from a non-deformed locked position (FIG.18) to a deformed unlocked position (FIG.20).

FIGS.17and18illustrate the tool assembly300with the anvil302in a clamped position and the lock mechanism380in an unlocked position. When the anvil302is moved to the clamped position (FIG.18) prior to firing of the stapling device10, the abutment member394engages the cutting member124of the knife120to deflect the abutment member394outwardly of the distal stop surface172of the clamp member152. In this position, the clamp member152can move along the drive screw150from its retracted position towards its advanced position to move the actuation sled112and the knife120through the staple cartridge106to eject staples114from the staple cartridge106and cut tissue clamped between the anvil302and the staple cartridge106.

FIGS.19and20illustrate the tool assembly300with the anvil302in the clamped position and the lock mechanism380in the locked position. After the stapling device10(FIG.1) is fired, the actuation sled112and the knife120(FIG.18) remain in the distal portion of the staple cartridge106. When the clamp member152is returned to its retracted position, the resilient arm390of the lock member382flexes inwardly to its non-deformed position to position the abutment surface394ain alignment with the distal stop surface172of the clamp member152. In this position, the lock member382prevents readvancement of the clamp member152within the tool assembly300.

FIGS.21-26illustrate a tool assembly400(FIG.24) including an alternate version of the anvil and lock mechanism of the stapling device10(FIG.1) which are shown generally as anvil402and lock mechanism480. The anvil402is substantially like the anvil302(FIG.16) except that the anvil402includes a second through bore408that receives a biasing mechanism484as described below. The lock mechanism480includes a lock member482, the biasing mechanism484, and a securement member486. In aspects of the disclosure, the securement member486includes a screw although other securement members are envisioned. The lock member482has a resilient arm490that includes a proximal portion490aand a distal portion490b. The proximal portion490adefines a first bore492and the distal portion490bincludes an abutment member494that has an abutment surface494a. The proximal portion490aof the lock member482is secured to an inner wall of one of the side flanges444of the anvil402in cantilevered fashion by inserting the screw486through the through bore406in the side flange444of the anvil402and the through the bore492in the proximal portion490aof the lock member482and securing the screw486to an inner surface of the anvil402. The arm490includes a central portion490cof reduced thickness that allows the arm490to flex outward from a non-deformed locked position (FIG.24) to a deformed unlocked position (FIG.26).

The biasing mechanism484includes a post484aand a biasing member484b. The post484aextends through the second through bore408in the anvil402and supports the biasing member484b. In aspects of the disclosure, the biasing member484bincludes a coil spring that is positioned about the post484aand is engaged with the abutment member494of the lock member482to urge the arm490of the lock member482towards the locked position.

FIGS.23and24illustrate the tool assembly400with the anvil402in a clamped position and the lock mechanism480in an unlocked position. When the anvil402is moved to the clamped position (FIG.24) prior to firing of the stapling device10, the abutment member494engages the cutting member124of the knife120to deflect the abutment member494against the urging of the biasing member484boutwardly of the distal stop surface172of the clamp member152. In this position, the clamp member152can move along the drive screw150from its retracted position towards its advanced position to move the actuation sled112and the knife120through the staple cartridge106to eject staples114from the staple cartridge106and cut tissue clamped between the anvil402and the staple cartridge106.

FIGS.25and26illustrate the tool assembly400with the anvil402in the clamped position and the lock mechanism480in the locked position. After the stapling device10(FIG.1) is fired, the actuation sled112and the knife120(FIG.26) remain in the distal portion of the staple cartridge106. When the clamp member152is returned to its retracted position, the arm490of the lock member482, which is urged by the biasing member484b, flexes inwardly to its non-deformed position to position the abutment surface494ain alignment with the distal stop surface172of the clamp member152. In this position, the lock member482prevents readvancement of the clamp member152within the tool assembly400.

FIGS.27-34illustrate a tool assembly500(FIG.30) including an alternate version of the anvil and lock mechanism of the stapling device10(FIG.1) which are shown generally as anvil502and lock mechanism580.FIGS.27and28illustrate the anvil502and the lock mechanism580. The anvil502is substantially like the anvil102(FIG.7) except that the anvil502defines first and second through bores510and512(FIG.28) that are positioned on opposite sides of a central knife slot516of the anvil502. Each of the through bores510and512is substantially rectangular. In some aspects of the disclosure, the anvil502defines circular recesses514on each side of the first through bore510.

The lock mechanism580includes a lock member582, a lock plate584, a first biasing member586, a second biasing member588, and a pivot member590. The lock plate584includes a body584athat includes a clevis592that extends through the first through bore510of the anvil502and a guide member594that extends through the second through bore512. The body584ais received within a recess596(FIG.30) defined in an outer surface of the anvil502and is movable between a raised position and a lowered position.

The lock member582, which may be in the form of a lever, has a first end that is pivotably coupled to the clevis592of the lock plate584and a second end that defines an abutment member598having an abutment surface598a. The lock member582is movable between an unlocked position (FIG.31) in which the abutment member598is spaced outwardly of the clamp member152and a locked position (FIG.34) in which the abutment member598is aligned with the distal stop surface172of the clamp member152to obstruct advancement of the clamp member152. The second biasing member588is received in the circular recesses514(FIG.27) in the anvil502and engages the pivot member590to urge the lock plate584towards its lowered position (FIG.34) within the recess596(FIG.30) in the outer surface of the anvil502. In aspects of the disclosure, the second biasing member588includes a coil spring. The first biasing member586includes a torsion spring and is engaged with the lock member582to pivot the lock member582about the pivot member590towards its locked position.

FIGS.29-31illustrate the tool assembly500with the anvil502in the clamped position and the lock mechanism580in the unlocked position. In the unlocked position, the abutment598of the lock member582is engaged with the knife120to prevent the lock member582from moving to the locked position. Engagement of the abutment member594of the lock member582with the knife120also prevents the second biasing member588from moving the lock plate584of the lock mechanism to its lowered position. When the lock plate584is in its raised position, a clinician is given notice that the knife120and the actuation sled112(FIG.29) of the staple cartridge106are in their retracted positions and the staple cartridge has yet to be fired.

FIGS.32-34illustrate the tool assembly500with the anvil502in the clamped position and the lock mechanism580in the locked position. After the stapling device10(FIG.1) is fired, the actuation sled112and the knife120(FIG.29) remain in the distal portion of the staple cartridge106. As such, when the clamp member152is retracted to a position proximally of the abutment member598of the lock member582, the lock member582is urged to its locked position in which the abutment surface598aof the abutment member598is aligned with and positioned distally of the distal stop surface172of the clamp member152to prevent distal movement of the clamp member152within the tool assembly500. The biasing member588also moves the lock plate584downwardly in the direction of arrow “A” inFIG.32to the lowered position to indicate to a clinician that the actuation sled112and knife120(FIG.29) are not positioned in the proximal portion of the staple cartridge506and the stapling device10(FIG.1) is not ready to fire.

As described above, each of the lock mechanisms disclosed is supported on the anvil of the tool assembly of the stapling device. By positioning the lock mechanism on the anvil, the lock mechanism remains in a locked position until the tool assembly is moved to the clamped position rather than upon insertion of the staple cartridge into the cartridge assembly of the stapling device.