The disclosure is directed to surgical stapling devices and, more particularly, to devices for detecting the presence of an actuation sled in a tool assembly of a surgical stapling device.
Surgical stapling devices for simultaneously stapling and cutting tissue are known in the art and are available in a variety of open and endoscopic configurations including linear, circular, and curved. Typically, linear surgical stapling devices that are configured for endoscopic use include a staple cartridge that includes a knife bar for cutting tissue and a sled that is movable through the staple cartridge to eject staples from the staple cartridge. In some devices, the sled is positioned to be engaged and advanced through the staple cartridge by the knife bar.
When an actuation sled is not present in the tool assembly, advancement of the knife bar through the staple cartridge of the stapling device cuts body tissue but does not affect stapling of the body tissue. This may have serious consequences for the patient. Although multiple checks are provided during a manufacturing process to confirm the presence of an actuation sled within a tool assembly of the stapling device, a continuing need exists in the art for a mechanism that can more accurately detect the absence of an actuation sled within the tool assembly and/or prevent the use of the tool assembly that does not include a sled assembly.
One aspect of the disclosure is directed to a surgical stapling device and package assembly including a stapling device, a shipping wedge, and a package. The stapling device includes a tool assembly including an anvil, a cartridge assembly, and a knife bar. The cartridge assembly is coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The cartridge assembly includes an actuation sled, and the knife bar and the actuation sled are movable through the tool assembly to eject staples from the staple cartridge. The shipping wedge is releasably coupled to the stapling device and includes a body and a detection member supported on the body for movement between first and second positions. The detection member is positioned to extend into the tool assembly and engage the actuation sled when the shipping wedge is coupled to the stapling device, wherein engagement of the detection member with the actuation sled moves the detection member from the second position to the first position. The package defines a cavity for receiving the stapling device and shipping wedge when the shipping wedge is coupled to the stapling device, the cavity being configured to receive the stapling device and shipping wedge within the cavity when the detection member is in the first position and to prevent reception of the stapling device and shipping wedge within the cavity when the detection member is in the second position.
In embodiments, the shipping wedge includes a biasing assembly that is positioned to bias the detection member towards the second position.
In some embodiments, the shipping wedge includes a housing portion that defines a channel and a transverse bore that extends through the housing portion into the channel, and the detection member defines a detection member bore that is aligned with the transverse bore when the detection member is in the first position and is misaligned with the transverse bore when the detection member is in the second position.
In certain embodiments, the package includes a post that positioned within the cavity and is configured to pass through the transverse bore of the housing portion of the shipping wedge and the detection member bore when the detection member is in the first position and to prevent placement of the stapling device and shipping wedge into the cavity when the detection member is in the second position.
In embodiments, the shipping wedge includes a plurality of resilient clip members that are configured to releasably engage the stapling device to secure the shipping wedge to the stapling device.
In some embodiments, the anvil includes a through bore and the detection member extends through the through bore and into the cartridge assembly when the shipping wedge is secured to the stapling device.
In certain embodiments, the shipping wedge includes a housing portion that defines a channel having first and second ends, and the detection member extends from the first end of the channel when the detection member is in the first position and extends from the second end of the channel when the detection member is in the second position.
In embodiments, the cavity of the package is configured to receive the stapling device and the shipping wedge when the detection member is in the first position and to prevent placement of the stapling device and the shipping wedge into the cavity when the detection member is in the second position.
Another aspect of the disclosure is directed to a surgical stapling device including a tool assembly, a body portion, and a shipping wedge. The tool assembly includes an anvil and a cartridge assembly coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The body portion supports a drive assembly including a knife bar. The cartridge assembly includes a channel and a staple cartridge positioned within the channel. The channel includes a wall defining a longitudinal slot that facilitates passage of the knife bar through the cartridge assembly. The staple cartridge includes an actuation sled, and the knife bar and the actuation sled are movable through the tool assembly from a retracted position to an advanced position to eject staples from the staple cartridge. The shipping wedge is releasably coupled to the stapling device and includes a body portion, a retaining member, and a detection member. The retaining member extends through the longitudinal slot in the channel of the cartridge assembly to secure the shipping wedge to the stapling device. The retaining member is movable within the longitudinal slot of the channel from a locked position in which the retaining member is locked within the longitudinal slot to an unlocked position in which the retaining member is removable from the longitudinal slot. The detection member is supported on the body for movement between first and second positions and extends into the tool assembly into engagement with the actuation sled when the shipping wedge is coupled to the stapling device. Engagement of the detection member with the actuation sled moves the detection member from the second position to the first position, wherein in the second position, the detection member is positioned to prevent movement of the retaining member from the locked position to the unlocked position.
In embodiments, the retaining member includes a vertical strut and a transverse shoulder, wherein the vertical strut extends through the longitudinal slot of the channel and the transverse shoulder engages the wall of the channel when the retaining member is in the locked position to obstruct removal of the shipping wedge from the stapling device.
In some embodiments, the vertical strut is movable within the longitudinal slot of the channel to move the retaining member between the locked position and the unlocked position.
In certain embodiments, the detection member is supported on a resilient arm that is positioned within the longitudinal slot of the channel adjacent to the vertical strut of the retaining member when the detection member is in the second position to prevent movement of the retaining member from the locked position to the unlocked position.
In embodiments, the shipping wedge includes a plurality of resilient clip members that are configured to releasably engage the stapling device to secure the shipping wedge to the surgical stapling device.
In some embodiments, the stapling device includes a mounting assembly that is secured to the tool assembly, wherein the mounting assembly pivotably couples the tool assembly to the body portion of the stapling device such that the tool assembly can pivot in relation to the body portion.
In certain embodiments, each of the plurality of clip members includes a finger that is received between the mounting assembly and the body portion of the stapling device when the shipping wedge is coupled to the tool assembly to obstruct pivotable movement of the tool assembly in relation to the body portion of the surgical stapling device.
In embodiments, the shipping wedge includes a stop member that is positioned to extend through the longitudinal slot of the channel to obstruct movement of the knife from the retracted position towards the advanced position when the shipping wedge is coupled to the stapling device.
In some embodiments, the shipping wedge includes a stop member that extends outwardly from the body portion and is positioned to engage the anvil when the shipping wedge is coupled to the tool assembly to retain the tool assembly in the open position.
Another aspect of the disclosure is directed to a surgical stapling device including a tool assembly, a body portion, and a shipping wedge. The tool assembly extends from the body portion and includes an anvil and a cartridge assembly coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The anvil defines a through bore. The body portion supports a drive assembly including a knife bar. The cartridge assembly includes a staple cartridge having an actuation sled, and the knife bar and the actuation sled are movable through the tool assembly to eject staples from the staple cartridge. The shipping wedge is releasably coupled to the stapling device and includes a body portion and a detection member supported on the body portion. The detection member is supported on a resilient arm that extends from the body portion and includes a locking member. The detection member is positioned to extend through the through bore of the anvil and into the tool assembly into engagement with the actuation sled when the shipping wedge is coupled to the stapling device. The detection member is movable between a first position in which the locking member is positioned externally of the through bore of the anvil when the shipping wedge is coupled to the stapling device to a second position in which the locking member is positioned through the through bore of the anvil when the shipping wedge is coupled to the stapling device to lock the shipping wedge onto the stapling device, wherein engagement between the detection member and the actuation sled during coupling of the shipping wedge to the stapling device moves the detection member from the second position to the first position.
In some embodiments, the locking member includes a stepped shoulder formed on the detection member.
In certain embodiments, the detection member includes a cam surface and the stepped shoulder is positioned along the cam surface.
In embodiments, the cam surface is positioned to engage a portion of the anvil defining the through bore to resiliently deform the detection member such that when the locking member passes through the through bore, the stepped shoulder snaps into engagement with the portion of the anvil defining the through bore to lock the shipping wedge onto the stapling device.
In some embodiments, engagement between the detection member and the actuation sled deforms the resilient arm to prevent entry of the locking member into the tool assembly.
Another aspect of the disclosure is directed to a surgical stapling device including a tool assembly and a body portion. The tool assembly extends from the body portion and includes an anvil and a cartridge assembly coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The body portion supports a drive assembly including a knife bar. The cartridge assembly includes a channel and a staple cartridge positioned within the channel having an actuation sled. The channel includes a wall defining a longitudinal slot that facilitates passage of the knife bar through the cartridge assembly, the knife bar and the actuation sled being movable through the tool assembly from a retracted position to an advanced position to eject staples from the staple cartridge. A locking member is supported on the channel that has a finger positioned distally of the knife bar. The finger is movable from a first position blocking distal movement of the knife bar to a second position removed from a path of the knife bar. The actuation sled is positioned between the finger of the locking member and the knife bar and includes an engagement member that is positioned to engage the finger of the resilient locking member when the knife bar is moved from the retracted position towards the advanced position to move the finger from the first position to the second position.
In embodiments, the locking member is formed of a resilient material and the finger is biased towards the first position.
In some embodiments, the engagement member of the actuation sled includes a ramp member that is movable into engagement with the finger to bias the finger to the second position.
Another aspect of the disclosure is directed to a tool assembly including a body portion, an anvil, and a cartridge assembly. The cartridge assembly is coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The body portion supports a drive assembly including a knife bar. The cartridge assembly includes a channel and an actuation sled. The channel has a wall defining a longitudinal slot that facilitates passage of the knife bar through the cartridge assembly such that the knife bar and the actuation sled are movable through the tool assembly to eject staples from the staple cartridge. The actuation sled supports a readable identifier that can be read to facilitate confirmation of the presence of an actuation sled within the tool assembly from a position externally of the tool assembly.
In embodiments, the readable identifier is a barcode.
In some embodiments, the readable identifier is an RFID.
In certain embodiments, the readable identifier is visible through the longitudinal slot of the channel of the cartridge assembly.
Another aspect of the disclosure is directed to a surgical stapling device including a tool assembly, a body portion, and a shipping wedge. The tool assembly extends from the body portion and includes an anvil defining a through bore and a cartridge assembly that is coupled to the anvil such that the tool assembly is movable between an open position and a clamped position. The body portion supports a drive assembly that includes a knife bar. The cartridge assembly includes a staple cartridge having an actuation sled. The knife bar and the actuation sled are movable through the tool assembly to eject staples from the staple cartridge. The shipping wedge is releasably coupled to the stapling device and includes a body portion and a detection member supported on the body portion. The detection member includes a locking member having a locking surface. The detection member is positioned to extend through the through bore of the anvil and into the tool assembly into engagement with the actuation sled when the shipping wedge is coupled to the stapling device. The detection member is movable between a first position in which the locking surface of the locking member does not pass through the through bore of the anvil when the shipping wedge is coupled to the stapling device to a second position in which the locking member passes through the through bore of the anvil when the shipping wedge is coupled to the stapling device to lock the shipping wedge onto the stapling device. The detection member is positioned to engage the actuation sled during coupling of the shipping wedge to the stapling device to move the detection member from the second position to the first position.
Another aspect of the disclosure is directed to a shipping wedge including a body portion and a detection member supported on the body portion. The detection member includes a locking member having a locking surface. The detection member is positioned to extend through a bore of a tool assembly into engagement with an inner component of the tool assembly when the shipping wedge is coupled to the tool assembly. The detection member is movable between a first position in which the locking surface of the locking member does not pass through the through bore of the tool assembly when the shipping wedge is coupled to the tool assembly to a second position in which the locking member is positioned to pass through the through bore of the tool assembly when the shipping wedge is coupled to the tool assembly to lock the shipping wedge onto the tool assembly. The detection member is positioned to engage the inner component of the tool assembly during coupling of the shipping wedge to the tool assembly to move the detection member from the second position to the first position.
In embodiments, the detection member is supported on a resilient arm that extends from the body portion of the shipping wedge.
In some embodiments, the locking surface of the locking member includes a stepped shoulder formed on the detection member.
In certain embodiments, the detection member includes a cam surface and the stepped shoulder is positioned along the cam surface.
In embodiments, the cam surface is positioned to engage a portion of the anvil defining the through bore to resiliently deform the detection member such that when the locking member passes through the through bore, the stepped shoulder snaps into engagement with the portion of the anvil defining the through bore to lock the shipping wedge onto the anvil.
In some embodiments, engagement between the detection member and the actuation sled deforms the resilient arm to prevent entry of the locking member into the tool assembly.
In certain embodiments, the detection member is coupled to the body portion of the shipping wedge by a pivot member.
In embodiments, the detection member includes an upper body portion and a lower body portion that supports the locking member.
In some embodiments, the locking member includes a resilient finger that extends towards the upper body portion and transversely outwardly from the lower body portion of the locking member.
In certain embodiments, the lower body portion of the detection member includes an engagement surface that is positioned to engage the actuation sled when the shipping wedge is attached to the tool assembly, wherein the engagement surface is angled towards the upper body portion in a proximal direction.
Various embodiments of the disclosed device for detecting the presence of an actuation sled within a tool assembly of a surgical stapling device are described herein below with reference to the drawings, wherein:
The disclosed devices for detecting the presence of an actuation sled within a tool assembly of a surgical stapling device and their associated methods of use 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 disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “endoscopic” is used generally used to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through small diameter incision or cannula. Further, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel.
Referring also to
The cartridge assembly 22 includes a staple cartridge 28 having a body 30 that defines a plurality of rows of staple receiving slots 32 and a knife slot 36. The staple receiving slots 32 are positioned on opposite sides of the knife slot 36 and receive a plurality of staples (not shown). The cartridge assembly 22 also includes a channel 38 that is positioned and dimensioned to receive the staple cartridge 28. The channel 38 includes a bottom wall 40 that defines a knife slot 40a (
The staple reload 10 includes a drive assembly 42 (
The shipping wedge 50 includes a body 56 that is formed of a resilient material and includes a grip portion 58, a housing portion 60, an extension 62, and a plurality of clip members 66 that extend from the grip portion 58 and/or the housing portion 60. The extension 62 extends distally from the housing portion 60 and may be grasped to assist in removal of the shipping wedge 50 from the staple reload 10. The clip members 66 are configured be snap-fit over the staple reload 10 to secure the shipping wedge 50 to the staple reload 10. In embodiments, the clip members 66 are semi-circular in shape and can flex outwardly to receive the staple reload 10.
The housing portion 60 of the shipping wedge 50 defines a channel 68 that is aligned with the through bore 26 in the anvil 20 when the shipping wedge 50 is coupled to the staple reload 10 and receives the detection device 52. The housing portion 60 of the shipping wedge 50 also defines a bore 70 that intersects and defines an axis that is transverse to the longitudinal axis of the channel 68.
The detection device 52 includes a detection member or slide 72 and a biasing member 74. The slide 72 is received within the channel 68 of the housing portion 60 and includes an abutment, e.g., flexible detent 76, that is received in a groove 78 formed in the housing portion 60 to limit movement of the slide 72 within the channel 68 between a first position (
The actuation sled 54 is received within the tool assembly 14 and is movable through the staple cartridge 28 in response to movement of the drive assembly 42 between retracted and advanced positions to eject staples (not shown) from the staple cartridge 28. See, e.g., the '993 and '683 Patents. When the actuation sled 54 is in its retracted position, the actuation sled 54 is aligned with the through bore 26 in the anvil 20. As such, when the shipping wedge 50 is attached to the staple reload 10, the slide 72 passes through the through bore 26 into the tool assembly 14 and into engagement with the actuation sled 54 when an actuation sled 54 is present within the tool assembly 14. When the slide 72 engages the actuation sled 54 as the shipping wedge 50 is clipped onto the staple reload 10, the slide 72 is moved from its second position to its first position (
Referring to
When the staple reload 10 and the shipping wedge 50′ assembly are placed within the blister package 90′ after manufacturing, a cavity 96′ defined by the package 90′ is configured to only receive the staple reload 10 and shipping wedge 50′ when the slide 72′ is in the first position (
The spacer 154 is supported on the distal portion of the central body portion 152 and includes a cantilevered leg 170 and a transverse portion 174. The cantilevered leg 170 extends outwardly from the central body portion 152 and defines a channel 172 with the central body portion 152 that is dimensioned to receive a distal portion of the cartridge assembly 22 (
The retaining member 158 of the shipping wedge 150 is also dimensioned to be received through the slot 40a in the bottom wall 40 of the channel 38 of the cartridge assembly 22 (
The detection member 160 (
The configuration of the shipping wedge 150 prevents removal of the shipping wedge 150 from the staple reload 10 when the tool assembly 14 does not include an actuation sled 54 to prevent use of the staple reload 10 when an actuation sled 54 is not present within the staple reload 10. This provides a clear indication to a clinician to discard the staple reload 10.
The detection member 258 extends from the body 252 in the direction of the clip members 260 and is positioned to extend through the through bore 26 of the anvil 20 into the tool assembly 14. The detection member 258 is supported on a resilient arm 262 that extends from the body 252 of the shipping wedge 250 and includes a curved body 264 having an engagement surface 264a. The curved body 264 includes a cam surface 266 including a locking member or surface. In embodiments, the locking member or surface includes a stepped shoulder 268. The cam surface 266 is positioned to engage an inner wall of the anvil 20 defining the distal end of the through bore 26 when the detection member 258 is inserted through the through bore 26 in the anvil 20.
When the shipping wedge 250 is secured to the staple reload 10, and the detection member 258 is inserted through the through bore 26 of the anvil 20, the engagement surface 264a of the detection member 258 is positioned to engage the actuation sled 54 within the tool assembly 14 to prevent further insertion of the detection member 258 into the tool assembly 258 (
Referring to
The configuration of the shipping wedge 250 prevents removal of the shipping wedge 250 from the staple reload 10 when the tool assembly 14 does not include an actuation sled 54 to prevent use of the staple reload 10. This provides a clear indication to a clinician to discard the staple reload 10.
Referring to
When the knife bar 344 is retracted, the knife bar 344 will engage the resilient finger 306 of the resilient locking member 304 and pass under the locking member 304 as it moves through the tool assembly towards its retracted position. In its retracted position, the knife bar 344 is positioned proximally of the resilient finger 306 of the locking member 304 and is ready for subsequent uses. In devices in which the staple cartridge is reusable such as devices that use multi-use loading units, the locking member 304 will function to lockout the tool assembly wherein newly loaded staple cartridges do not include an actuation sled.
In an alternate embodiment, the bar code can be replaced with a radio frequency identification tag (“RFID”) that is affixed to the actuation sled 454B (
The detection member 608 extends from the body 602 of the shipping wedge 600 in the direction of the clip members 610 and is positioned to extend through a through bore 726 (
The locking member 622 includes a resilient finger 636 that extends towards the upper body portion 614a and transversely outwardly from the lower body portion 614b of the locking member 622. The resilient finger 636 is positioned to prevent the detection member 608 from being removed from the anvil 720 of the tool assembly 714 when the resilient finger 636 passes through the slot 726 to prevent removal of the shipping wedge 600 from the staple reload 700 to effectively disable the staple reload 700.
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
This application is a continuation of U.S. patent application Ser. No. 17/745,144, filed May 16, 2022, now U.S. Pat. No. 11,701,108, which is a continuation of U.S. patent application Ser. No. 16/837,586, filed Apr. 1, 2020, now U.S. Pat. No. 11,331,098, the entire contents of each of which are incorporated by reference herein.
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Number | Date | Country | |
---|---|---|---|
Parent | 17745144 | May 2022 | US |
Child | 18220393 | US | |
Parent | 16837586 | Apr 2020 | US |
Child | 17745144 | US |