Surgical stapling device with two-position lockout mechanism

Abstract

To provide a surgical stapler with a lockout mechanism.SOLUTION: When a jaw assembly 270 is empty, the empty jaw assembly lockout mechanism can arrest an open-close stroke of the jaw assembly. When an at least partially fired reload is present in the jaw assembly, a fired reload lockout mechanism can allow operation of the jaw assembly through a substantial portion of an open-close stroke, but restrict operation of the jaw assembly in a firing stroke. The separate lockout mechanisms can be embodied in a single lockout lever actuatable by lockout actuators in three distinct positions or in two independently operable lockout levers.SELECTED DRAWING: Figure 12

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 62 / 811457, entitled "Surgical Stapling Instrument Having a Two - Position Lockout Mechanism", filed on February 27, 2019, the entire disclosure of which is hereby incorporated by reference.

[0002] This application generally relates to surgical occlusion instruments, and more specifically to surgical staplers.

Background Art

[0003] Surgical staplers are used to bring tissue together or clamp tissue and staple the clamped tissue together. Thus, surgical staplers have mechanisms to ensure proper positioning and capture of the tissue and to pass staples through the tissue. As a result, multiple triggers and handles have been produced in relation to complex mechanisms for, for example, properly stapling clamped tissue. These complex mechanisms can result in high manufacturing overhead and potential sources of device failure and user confusion. Thus, it is desirable to be able to reliably staple clamped tissue without the accompaniment of complex mechanisms.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

[0005] Surgical staplers may further include a cutting blade for cutting the tissue to be stapled. These staplers may have a mechanism to restrict the movement of the cutting blade when no staples are present in the device. To enhance the user's tactile experience and patient safety in some stapler configurations, it is desirable to further improve the mechanism for restricting the movement of the cutting blade of the surgical stapler. [Means for solving the problem]

[0006] In some embodiments of this specification, surgical stapling devices are provided. A surgical stapling device includes an elongated shaft, a firing beam, and a jaw assembly. The elongated shaft has a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The firing beam has a proximal end and a distal end. At least a portion of the firing beam is longitudinally slidable within the elongated shaft. A firing member is present at the distal end of the firing beam. The jaw assembly is located at the distal end of the elongated shaft. The jaw assembly includes a first jaw, a second jaw, an empty jaw assembly lockout mechanism, and a fired reload lockout mechanism. The first jaw defines an anvil. The second jaw defines a reload support configured to house a reload cartridge having multiple staples deployable from the reload cartridge. The first jaw is pivotally coupled to the second jaw. The launching member is longitudinally slidable within the jaw assembly to move the jaw assembly in an opening / closing stroke that pivots the first jaw from an open configuration to a closed configuration relative to the second jaw, and a firing stroke distal to the opening / closing stroke that fires staples from the reload cartridge. An empty jaw assembly lockout mechanism restricts the distal movement of the launching member in the opening / closing stroke when no reload cartridge is present in the reload support. A fired reload lockout mechanism prevents the distal movement of the launching member from the opening / closing stroke to the firing stroke.

[0007] In some embodiments of this specification, a surgical stapler is provided. The surgical stapler includes an elongated shaft, a launch beam, a launch member, and a jaw assembly. The elongated shaft has a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The launch beam has a proximal end and a distal end. At least a portion of the launch beam is longitudinally slidable within the elongated shaft. The launch beam includes a first notch formed internally and a second notch formed internally. The launch member is located at the distal end of the launch beam. The jaw assembly is located at the distal end of the elongated shaft. The jaw assembly includes a first jaw, a second jaw, and a lockout lever. The first jaw defines an anvil. The second jaw defines a reload support configured to house a reload cartridge having multiple staples deployable from the reload cartridge. The lockout lever is pivotably coupled to the second jaw. The lockout lever has a proximal end, a distal end, and a pivot axis between the proximal and distal ends. The lockout lever is pivotable between a first position where the proximal end of the lockout lever is at a first height corresponding to a first notch, a second position where the proximal end of the lockout lever is at a second height corresponding to the position of a second notch, and an unlocked position where the proximal end of the lockout lever is at a third height spaced apart from the first and second notches.

[0008] In some embodiments of this specification, a surgical stapler is provided. The surgical stapler includes an elongated shaft, a launch beam, a launch member, and a jaw assembly. The elongated shaft has a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The launch beam has a proximal end and a distal end. At least a portion of the launch beam is longitudinally slidable within the elongated shaft. The launch beam includes a first notch formed internally and a second notch formed internally. The launch member is located at the distal end of the launch beam. The jaw assembly is located at the distal end of the elongated shaft. The jaw assembly includes a first jaw, a second jaw, a first lockout lever, and a second lockout lever. The first jaw defines an anvil. The second jaw defines a reload support configured to house a reload cartridge having a plurality of staples deployable from the reload cartridge. The first lockout lever is pivotably coupled to the second jaw. The first lockout lever has a proximal end, a distal end, and a pivot axis between the proximal and distal ends. The second lockout lever is pivotably coupled to the second jaw. The second lockout lever has a proximal end, a distal end, and a pivot axis between the proximal and distal ends. The first lockout lever is pivotable between a first position where the proximal end of the first lockout lever is at a first height spaced away from the first notch, and a second position where the proximal end of the first lockout lever is at a second height corresponding to the position of the first notch. The second lockout lever is pivotable between a first position where the proximal end of the second lockout lever is at a first height spaced away from the second notch, and a second position where the proximal end of the second lockout lever is at a second height corresponding to the position of the second notch. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of an embodiment of a surgical stapling device in which the jaws are in an open configuration. [Figure 2] Figure 1 is a perspective view of an embodiment of the reload shaft of a surgical stapling device in which the jaws are in a closed configuration. [Figure 3] This is a perspective view of an embodiment of a handle assembly having an articulated joint mechanism for a surgical stapling device. [Figure 4] This is a perspective view of an embodiment of a surgical stapling system having an electric handle. [Figure 5] Figure 1 is a side view of the electric handle of the surgical stapling system. [Figure 6] This is a perspective view of the reload lockout mechanism of the shaft assembly. [Figure 7] This is a side view of the reload lockout mechanism of the shaft assembly. [Figure 8] This is a side view of the reload lockout mechanism of the shaft assembly in a locked configuration. [Figure 9] This is a side view of the reload lockout mechanism of the shaft assembly in the unlock configuration. [Figure 10] This is a perspective view of a reload cartridge used in several embodiments of a surgical stapling device. [Figure 11] This is a perspective view of the launch beam and launch member used in several embodiments of the elongated shaft assembly of a surgical stapling device. [Figure 12] This is a partially exploded perspective view of the proximal end of the jaw assembly in several embodiments of an elongated shaft assembly of a surgical stapling device. [Figure 13] This is a cutaway side view of the proximal end of a jaw assembly in several embodiments of an elongated shaft assembly for a surgical stapling device. [Figure 14] Figure 13 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 15] Figure 13 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 16] Figure 13 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 17]A notch side view of the proximal end of the Joe assembly of FIG. 13 with an un-fired reload inserted. [Figure 18] A notch side view of the proximal end of the Joe assembly of FIG. 13 with a at least partially fired reload inserted. [Figure 19] A notch side view of the proximal end of the Joe assembly of FIG. 13 with no reload inserted. [Figure 20] A perspective view of a firing beam and a firing member used in some embodiments of an elongated shaft assembly of a surgical stapling device. [Figure 21] A partial exploded perspective view of the proximal end of a Joe assembly used in some embodiments of an elongated shaft assembly of a surgical stapling device. [Figure 22] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the first side with an un-fired reload cartridge inserted. [Figure 23] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the second side with an un-fired reload cartridge inserted. [Figure 24] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the second side with a fired reload cartridge inserted. [Figure 25] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the first side with no reload cartridge inserted. [Figure 26] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the first side with no reload cartridge inserted and the firing beam not advanced longitudinally. [Figure 27] A notch side view of the proximal end of the Joe assembly of FIG. 21 as seen from the second side with no reload cartridge inserted.

Best Modes for Carrying Out the Invention

[0010] Figures 1 to 5 show embodiments of surgical stapling devices. The embodiments of the stapling device shown in Figures 1 to 3 include a mechanical handle assembly 40, and the embodiments of the stapling device shown in Figures 4 to 5 include an electric handle assembly 40'. The illustrated embodiment of the surgical stapler 10 includes an elongated shaft 20, a jaw assembly 30, and handle assemblies 40, 40'. Various embodiments of the elongated shaft 20 and jaw assembly 30 described herein can be used indiscriminately with either the mechanical handle assembly 40 or the electric handle assembly 40'. Figure 1 shows the surgical stapler 10 with the jaw assembly 30 in an open configuration. Figure 2 shows a removable reload shaft assembly including the elongated shaft 20 and jaw assembly 30 of the surgical stapler 10 with the jaw assembly 30 in a closed configuration.

[0011] Continuing with reference to Figures 1 and 2, the illustrated embodiment of the surgical stapler 10 can have a size and configuration suitable for use in laparoscopic surgery. For example, the elongated shaft 20 and jaw assembly 30 can have a size and configuration suitable for introduction into the surgical field through an access port or trocar cannula. In some embodiments, the elongated shaft 20 and jaw assembly 30 can have a size and configuration suitable for insertion through a trocar cannula having a relatively small working channel diameter, such as less than 8 mm. In other embodiments, the elongated shaft 20 and jaw assembly 30 can have a size and configuration suitable for insertion through a trocar cannula having an even larger working channel diameter, such as 10 mm, 11 mm, 12 mm, or 15 mm. In other embodiments, it is conceivable that some aspects of the surgical stapler described herein could also be incorporated into a surgical stapling device used in open surgery.

[0012] Continuing to refer to Figures 1 and 2, as shown in the figures, the elongated shaft 20 includes a generally tubular member. The elongated shaft 20 extends from the proximal end to the distal end. The elongated shaft 20 defines the central longitudinal axis L of the surgical stapler 10, which extends between the proximal end 22 and the distal end 24.

[0013] Continuing to refer to Figures 1 and 2, in the illustrated embodiment, a jaw assembly 30 is coupled to the elongated shaft 20 at its distal end 24. The jaw assembly 30 includes a first jaw 34 pivotally coupled to a second jaw 32. In the embodiments shown in Figures 1 and 2, the jaw assembly is fixed in an orientation aligned longitudinally with the central longitudinal axis L. In other embodiments, the elongated shaft may include a jaw assembly articulated to the elongated shaft so that the jaw assembly can be selectively positioned in an articulated position relative to the central longitudinal axis L. The handle assembly in Figure 3 includes an articulation knob 190 and an articulation mechanism configured to allow continuously selectable articulation throughout the articulation range of the jaw assembly of the elongated shaft assembly. In the initial configuration, the second jaw 32 includes a plurality of staples 36 located inside it.

[0014] Continuing to refer to Figures 1 and 2, in the illustrated embodiment, the jaw assembly 30 can be operated from an open configuration (Figure 1) to a closed configuration (Figure 2) relative to a staping configuration by an actuating member or beam that is longitudinally slidable within an elongated shaft. In the initial position, the beam can be located at the distal end 24 of the elongated shaft 20. With the beam in the initial position, the jaw assembly 30 becomes open by the first jaw 34 pivoting away from the second jaw 32. As the actuating member or beam is translated distally along the longitudinal axis L, the actuating beam engages with the first jaw 34. When the actuating beam is translated distally by a first distance from the initial position, the jaw assembly can be operated from the open configuration to the closed configuration. When the jaw assembly 30 is in the closed configuration, the jaw assembly 30 can be returned to the open configuration by moving the actuating beam proximally by a first distance. The distal end of the working beam can advance a staple slider configured to deploy staples from a second jaw 32, so that as the working beam moves further distally beyond a first distance, a plurality of staples 36 are deployed from the second jaw 32.

[0015] Referring to Figures 1 to 3, in the illustrated embodiment, the handle assembly is coupled to the elongated shaft 20 at its proximal end 22. As shown, the handle assembly 40 has a pistol grip configuration including a housing that defines a fixed handle 42 and a movable handle 44 or trigger pivotably coupled to the fixed handle 42. In other embodiments, it is assumed that surgical stapler devices, including the embodiments described herein, may also have handle assemblies in other configurations, such as a scissor grip configuration or an in-line configuration. The handle assembly 40 houses an operating mechanism configured to selectively advance the operating shaft to operate an operating beam in the elongated shaft by a first distance in an opening / closing stroke to close the jaw assembly from an initial open position, and to operate it by a second distance exceeding the first distance in a firing stroke to fire a staple, and to return the operating beam to the initial position by the second and first distances in response to the movement of the movable handle 44. In some embodiments, a sliding selector 72 on the handle assembly allows the user to select whether the handle assembly operates to operate the jaw assembly in an opening / closing stroke or in a firing stroke. Various embodiments of the handle assembly and associated actuation mechanism are disclosed in U.S. Patent No. 9,668,732, entitled "Surgical Stapler Handle Assembly Having Actuation Mechanism With Longitudinal Rotatable Shaft," and U.S. Patent Application No. 15 / 485620, filed April 12, 2017, entitled "Surgical Stapler Having Articulation Mechanism," both of which are incorporated herein by reference in their entirety.

[0016] Referring to Figure 2, in some embodiments, the surgical stapler 10 may include multiple staples 36 located in a disposable reload cartridge 50, while the handle assembly 40 and elongated shaft 20 are configured to be reused with multiple staple reload cartridges. The gripping and firing lockout mechanisms described herein have the advantage of being able to restrict the function of the handle assembly and warn the user if there is no reload cartridge in the jaw assembly, or if there is a partially or completely fired reload cartridge in the jaw assembly, thereby enhancing patient safety. In an exemplary embodiment of Figure 1, the elongated shaft 20 and jaw assembly 30 define a reusable shaft assembly that can be detachably coupled to the handle assembly 40. The shaft assembly and its one or more disposable cartridges can restrict the function of the handle assembly after staples have been partially or completely fired from the jaw assembly using various embodiments of the lockout mechanisms described herein.

[0017] Referring to Figure 3, the handle assembly 40 includes a coupler 46 at its distal end. The coupler 46 is fitted to engage with the elongated shaft 20 of the surgical stapler 10. The coupler 46 may have a bayonet connection having an outer connector that can detachably connect the handle assembly 40 to the elongated shaft 20 and an inner connector that can detachably connect the working shaft of the handle assembly 42 to the working member of the elongated shaft 20. Thus, the surgical stapler 10 can be configured so that the handle assembly 40 can be reused during surgery along with multiple shaft assemblies and reload cartridges. In other embodiments, it is assumed that the handle assembly and some parts of the elongated shaft can be reused, while the rest of the elongated shaft and jaw assembly define a disposable cartridge. In some other embodiments, the handle assembly and elongated shaft can be reused, while the jaw assembly defines a disposable cartridge. In yet another embodiment, the jaw inserts that house multiple staples may define a disposable cartridge, while the rest of the surgical stapler is reusable.

[0018] Figures 4 and 5 show embodiments of a surgical stapling system including an electric handle assembly. The illustrated embodiment of the surgical stapler 10' includes an elongated shaft 20, a jaw assembly 30, and a handle assembly 40'. Figure 4 shows an embodiment of the surgical stapler 10' with the jaw assembly 30 in an open configuration, and an embodiment of an electric handle having powered staple firing and manual jaw assembly articulation. Figure 5 shows the electric handle 40' of the surgical stapler system 10' with the elongated shaft removed. In the illustrated embodiments, the shaft 20 and the jaw assembly 30 can be freely rotated around a longitudinal axis defined by the shaft 20 by rotating the rotary knob on the handle 40'. In other embodiments, the stapling system can be configured to allow rotation of the jaw assembly within a predetermined range around the longitudinal axis, or to allow a rotatably fixed jaw assembly.

[0019] Figure 5 shows an embodiment of a motorized handle for a surgical stapling system. The motorized handle can be used with various shaft reloads and cartridges to allow selection of shaft configurations, jaw assembly configurations, and staple configurations to suit specific surgeries. The motor is controlled by an implanted control system that determines the function of the handle during different stages of use. The joint movement of the jaw assembly can be manually controlled by an articulation knob 190' rotated by the operator. In the illustrated embodiment, the articulation knob 190' is located at the proximal end of the motorized handle and is rotatable around an axis that roughly corresponds to the longitudinal axis of the stapling system.

[0020] Continuing to refer to Figure 5, the electric handle 40' includes a pistol grip configuration having a fixed handle 42' and a movable handle 44' or trigger pivotably coupled to the fixed handle 42'. A power supply 130 or battery may be located on the underside of the fixed handle. The electric handle 40' may further include user controls such as a firing or firing / reversing button 150, which allows the user to selectively control the stapling sequence and selectively actuate the handle assembly to operate the jaw assembly in an open / close stroke and a firing stroke. The electric handle 40' may further include a redundant manual override return system 170, which allows the user to manually return the stapling system to an open configuration in the event of electric system failure, control system failure, power supply failure, "lockjaw" or other mechanical binding.

[0021] Various embodiments of the powered handle assembly and associated operating mechanisms are disclosed in U.S. Patent Application No. 15 / 486,227, filed April 12, 2017, entitled "Reload Shaft Assembly for Surgical Stapler," and U.S. Patent Application No. 15 / 486,008, filed April 12, 2017, entitled "Surgical Stapler Having a Powered Handle," both of which are incorporated herein by reference in their entirety.

[0022] Referring to Figures 6, 7, 8, and 9, in some embodiments the jaw assembly may include a binary reload lockout mechanism 80. The reload lockout mechanism 80 can prevent the forward movement of the launcher when no reload is located in the jaw assembly or when an empty reload is located in the jaw assembly. The reload lockout mechanism 80 includes a lockout lever 82 pivotably coupled to a reload support. The axis defined by the pivot extends roughly across the longitudinal axis of an elongated shaft. When the launcher 240 is fully retracted and the jaw assembly is in an open configuration, a tail 247 extending proximally from the launcher 240 pivots and maintains the lockout lever 82 in the unlocked position. In the illustrated embodiments, the proximal portion of the lockout lever 82 near the pivot axis is forked or bifurcated to accommodate the launcher 240 inside, so that the tail 247 can act on the surface of the lockout lever 82 near the pivot axis. If no reload is inserted, attempting to advance the launch member 240 causes the tail portion 247 of the launch member to move distally along the lockout lever, allowing the lockout lever to pivot from the unlocked position to the locked position around the pivot point 84 (Figure 8). When the lockout lever 82 is in the locked position, the proximal lock end 86 of the lockout lever interferes with the lock recess 60 on the drive member 26, preventing further distal movement of the drive member.

[0023] Continuing to refer to Figures 6, 7, 8, and 9, when an unfired reload is inserted into the reload support (Figure 9), the tail portion 54 extending proximal from the slider 55 engages with the distal end of the lockout lever 82. The slider 55 is longitudinally slidable within the reload, from a proximal to a distal position, to deploy multiple staples from the reload. As shown, the tail portion 54 acts on the underside of the distal portion of the lockout lever 82 away from its pivot point. This engagement between the slider tail portion 54 and the distal end of the lockout lever 82 causes the proximal end of the lockout lever 82 to pivot away from the drive member 26, even if the tail portion 247 of the firing member 240 no longer acts on the proximal portion of the lockout lever. Thus, the drive member 26 and the firing member 240 can advance distally to fire staples from the reload. Once the firing stroke is complete, the slider 55 remains at the distal end of the reload. Therefore, when returning the jaw assembly to the open configuration and retracting the firing member, the fired reload should be removed, a new unfired reload inserted, and the reload lockout released.

[0024] The dual lockout lever reload lockout mechanism described with respect to Figures 6 to 9 advantageously prevents the firing of the jaw assembly when no reload cartridge is present or when a partially or completely fired reload is present, while under certain conditions, it is possible to close the jaw assembly and advance the firing member 240 to the pre-firing position within the jaw assembly by operating the handle assembly to activate the jaw assembly in the opening and closing motion and the initial part of the firing stroke. The safety of the dual lockout mechanism can be enhanced by positioning the lock recess 60 of the drive member at a position corresponding to the position on the firing member 240 within the opening and closing stroke of the jaw assembly, or by including a stop member or protective member to protect the blade of the firing member, so that the blade of the firing member 240 retracts when the lockout mechanism is locked. However, further improvements and advantages can also be achieved by using an independent empty jaw assembly lockout mechanism and a fired reload lockout mechanism. As will be further described below, in some embodiments, these independent mechanisms can be linked by a two-position lockout lever having two lockout positions and one unlock position (Figures 12 to 19), or by a lockout lever assembly having two independently operable lockout levers (Figures 21 to 27).

[0025] Figure 10 shows a reload cartridge 250 used with an elongated shaft of a surgical stapler device having an independent empty jaw assembly and a fired reload lockout mechanism. As will be further described below, if a user attempts to grip the jaw assembly in an opening / closing stroke without a reload cartridge 250 present in the jaw assembly, a two-position lockout lever moves to a first locked position. As shown, the reload cartridge includes a first lockout actuator sized and positioned to position the two-position lockout lever to a second position that defeats the empty jaw assembly lockout mechanism when a reload is located within the reload support of the jaw assembly. In some embodiments, the first lockout actuator may include a ramped boss 252 extending laterally inward from the side wall of the cartridge body.

[0026] Continuing to refer to Figure 10, in the illustrated embodiment, the reload cartridge 250 includes a second lockout actuator of a size and configuration such that it positions a two-position lockout lever in an unlocked position, which disables the fired reload lockout mechanism when an unfired reload is located within the jaw assembly. Thus, the two-position lockout lever can pivot to an unlocked position in addition to the two lockout positions. In some embodiments, the second lockout actuator includes a tail 254 extending proximal from the slider 255 of the reload cartridge 250. When the reload cartridge 250 is unfired, the slider 255 is in a proximal position such that the slider tail 254 extends proximal and engages with the lockout lever. As the firing member advances distally in its firing stroke, it strikes the slider in the reload cartridge, causing the slider to advance distally. As the slider 255 advances longitudinally distally from the proximal position to the distal position within the reload, several staples are deployed from the reload. Therefore, when the reload cartridge 250 is partially (or fully) fired, the slider tail 254 extending in the proximal direction is no longer in a position that disables the fired reload lockout mechanism.

[0027] Figure 11 shows a launch beam 226 used with an elongated shaft assembly of a surgical stapler device having an independent empty jaw assembly and a launched reload lockout mechanism. The launch beam 226 extends from a proximal end to a distal end 230. A launch member 240 having a roughly I-beam configuration is positioned at the distal end 230 of the launch beam 226. The upper and lower horizontal flanges 242, 244 of the I-beam launch member 240 ride on the channels of the first and second jaws of the jaw assembly to bring the jaws closer together and maintain the spacing between the jaws during subsequent staple launches. Cutting edges 245 are positioned on the vertical portion of the I-beam profile to cut tissue between rows of staples. The I-beam launch member 240 can be attached to the distal end of the launch beam 226 by interlock fit, welding, another joining method, or any combination thereof. The proximal edge of the I-beam launch member 240 may have a proximal projection or tail 247 that can rest on the proximal portion of the lockout lever when the launch beam 226 is in a fully retracted position corresponding to the open jaw assembly.

[0028] Continuing to refer to Figure 11, the launch beam may include a first lockout notch 222 used with an empty jaw assembly lockout mechanism and a second lockout notch 224 used with a fired reload lockout mechanism. In the illustrated embodiment, the first lockout notch 222 extends by a first height from the adjacent lower edge 220 of the launch beam 226. As will be further described below, the first height is selected to correspond to the height of the proximal end of the lockout lever when the empty jaw assembly lockout is activated by an attempt to bring the jaw assembly closer in the absence of a reload cartridge.

[0029] Continuing to refer to Figure 11, in the illustrated embodiment, the second lockout notch 224 is located on the launch beam proximal to the first lockout notch 222. The second lockout notch 224 extends by a second height from the adjacent lower edge 220 of the launch beam 226. As will be further described below, the second height is selected to correspond to the height of the proximal end of the lockout lever when the fired reload lockout mechanism is activated by an attempt to fire a previously fired or partially fired reload.

[0030] In the illustrated embodiment of the launch beam 226, by having substantially continuous first lockout notches 222 and second lockout notches 224, the adjacent lower edges 220 of the launch beam are reduced over the longitudinal distance corresponding to the first lockout notches 222 and second lockout notches 224. In other embodiments, it is conceivable that the first and second lockout notches can be spaced apart from each other by an unreduced segment of the lower edge of the launch beam. As will be further described below, the height and longitudinal position of the first and second lockout notches can be configured to achieve desired operating characteristics of the stapler handle assembly.

[0031] Figures 12 and 13 show a partial exploded view (Figure 12) and a cutaway side view (Figure 13) of a portion of a jaw assembly 270 with various components concealed for the purpose of illustrating an empty jaw assembly lockout mechanism and a fired reload lockout mechanism. In some embodiments, the lockout mechanism includes a two-position lockout lever 280, a biasing spring 290, a first lockout notch 222, and a second lockout notch 224. The two-position lockout lever 280 has a distal end 282 configured to engage with a first lockout actuator and a second lockout actuator on a reload cartridge, a pivot shaft 284 adjacent to the distal end, and a proximal end 286 configured to engage with either the first lockout notch or the second lockout notch, or not to engage with either. The biasing spring 290 has at least one lower spring arm 292 that biases the distal end of the lockout lever 280 on the pivot shaft 284 downward toward the reload support of the second jaw 274. In the illustrated embodiment, the biasing spring has two lower spring arms 292, with a gap between them through which the launch member 240 and the launch beam 226 can pass. The biasing spring 290 may have at least one upper spring arm 294 that biases the first jaw 272 toward an open configuration. The biasing spring 290 may be configured to straddle the launch beam 226 and may have a central saddle member from which at least one lower spring arm 292 and at least one upper spring arm 294 extend.

[0032] Figures 14–19 illustrate the operation of two lockout mechanisms. In the partial cutaway side views of the proximal end of some embodiments of these jaw assemblies, some elements of the jaw assembly (such as biasing springs) are not shown, and some components (such as the firing member 240) are shown as transparent elements to improve visibility of the operation of the lockout mechanism. Figures 14–17 illustrate the function of the lockout mechanism when a fully unfired staple reload 250 cartridge is located within the reload support of the second jaw 274. Figure 18 illustrates the operation of the fired reload lockout mechanism. Figure 19 illustrates the operation of the empty jaw assembly lockout mechanism.

[0033] Figure 14 shows a cutaway of the proximal end of the jaw assembly. The jaw assembly is in an open configuration such that the first jaw 272 is biased to an open position relative to the second jaw 274. The launch member 240 and launch beam 226 are in a fully retracted position in the proximal direction such that the proximal face of the lockout lever 280 rests on the tail portion 247 extending proximal to the launch member 240. As a result, the distal end 282 of the lockout lever 280 rises slightly away from the reload support, allowing the lockout actuator to be positioned between the reload support and the lockout lever 280.

[0034] Continuing to refer to Figure 14, a slight upward movement of the distal end 282 of the lockout lever 280 allows it to receive the inclined proximal surface or inclined boss 252 of the first lockout actuator formed on the reload cartridge body. The distal end 282 of the lockout lever 280 has a lateral extension 283 (Figure 12) positioned to engage with the first lockout actuator when the reload cartridge 250 slides proximal when the jaw assembly is inserted into the reload support, and an inner surface 281 (Figure 12) positioned to engage with the second lockout actuator.

[0035] Figure 15 shows a cutaway of the proximal end of the jaw assembly with a partially inserted reload 250 cartridge. As shown, the lateral extension 283 of the distal end 282 of the lockout lever 280 engages with the inclined proximal surface 283 of the inclined boss 252. As the reload 250 cartridge slides further proximal, the lateral extension 283 rises its inclined surface to a first height relative to the reload support, pivoting the lockout lever 280 to a second position and disabling the empty jaw assembly lockout mechanism. The operation of the empty jaw assembly lockout mechanism will be further described below with reference to Figure 19. In the illustrated embodiment, when the distal end 282 of the lockout lever 280 is raised to a first height from the reload support by the first lockout actuator, the second lockout actuator or slider tail 254 of the unfired reload 250 cartridge is positioned at a height immediately distal to the first lockout actuator, so as to engage with the inner surface 281 of the distal end 282 of the lockout lever 280. Thus, when viewed in a cutaway side view as shown in Figure 15, the first and second lockout actuators define a progressive ramped profile configured to raise the distal end 282 of the lockout lever 280 to two predetermined positions when the reload 250 cartridge is inserted into the reload support.

[0036] Figure 16 shows a cutaway of the proximal end of the jaw assembly with the reload 250 cartridge nearly fully inserted. As shown, the inner surface 281 of the distal end 282 of the lockout lever 280 engages with the inclined proximal surface of the second lockout actuator or slider tail 254. In the illustrated embodiment, the tail 254 extending proximal to the slider of the reload 250 has a lead-in ramped surface that engages with the distal end 282 of the lockout lever 280 when the reload cartridge is in an unfired state. In some embodiments, the lockout lever 280 and the slider tail 254 can be configured to enable smooth, relatively low-friction reload insertion, reducing the possibility of the slider becoming trapped or unintentionally advancing during cartridge insertion. For example, in some embodiments, the inner surface 281 of the distal end 282 of the lockout lever 280 may have a rounded distal end so that the lockout lever 280 pivots by interaction with the slider tail despite the possibility of slight angular misalignment between the reload 250 cartridge and the reload support. Furthermore, in some embodiments, the inclined proximal surface of the slider tail 254 may extend from a first height relative to the reload support at a proximal end lower than the height of the first lockout actuator relative to the reload support. Thus, when an unfired reload 250 cartridge is located within the reload support, the distal end 282 of the lockout lever 280 can smoothly transition from the first lockout actuator to the second lockout actuator with a wide range of angular alignment between the reload cartridge and the reload support.

[0037] Figure 17 shows a cutaway of the proximal end of the jaw assembly with a fully inserted reloaded 250 cartridge. As shown, the inner surface 281 of the distal end 282 of the lockout lever 280 advances along the inclined proximal surface of the second lockout actuator or the slider tail 254. This advance along the inclined surface of the slider tail 254 causes the lockout lever 280 to pivot around the pivot axis 284, so that the distal end 282 of the lockout lever 280 is at a second height relative to the reload support. With the distal end of the lockout lever 280 at the second height, the lockout lever is in the unlocked position corresponding to the unlocked state of the empty jaw assembly lockout mechanism and the unlocked state of the fired reload lockout mechanism.

[0038] Continuing to refer to Figure 17, when the lockout lever 280 is in the unlocked position, the proximal end 286 of the lockout lever 280 is positioned lower than the lower edge of the firing beam. Thus, the firing member 240 and the firing beam 226 can advance distally through the opening / closing stroke and firing stroke in response to user input from a mechanically or electrically operated handle assembly (Figures 1-5) that is operably coupled. Consequently, when an unfired reload cartridge is inserted into the reload support of the jaw assembly, both the empty jaw assembly lockout mechanism and the fired reload lockout mechanism are deactivated, allowing the user to operate the stapler handle assembly to grasp tissue with the jaw assembly and fire staples from the jaw assembly by translating the firing beam and firing member distally within the jaw assembly.

[0039] As can be seen with reference to Figure 18, when the reload 250 cartridge is at least partially fired, the slider within the reload 250 advances distally from its proximal unfired position. Once the firing stroke is complete, the slider remains in the distal position within the reload cartridge, allowing the firing beam 226 and firing member 240 to retract proximal in response to operation of the handle assembly during the return or retraction stroke. Thus, when the reload 250 cartridge is partially or fully fired, the second lockout actuator or slider tail is no longer in a position to engage with the distal end 282 of the lockout lever 280. However, in some embodiments, the first lockout actuator or inclined boss 252 does not move relative to the cartridge body. Therefore, when the partially or fully fired reload 250 is located within the reload support, the first lockout actuator engages with the distal end 282 of the lockout lever 280, positioning the distal end 282 of the lockout lever 280 at a first height relative to the reload support. When the distal end 282 of the lockout lever 280 reaches a first height corresponding to the second position of the lockout lever, the empty jaw assembly lockout mechanism is disabled, but the fired reload lockout mechanism is locked.

[0040] Continuing to refer to Figure 18, when the lockout lever 280 is in the second position, the proximal end 286 of the lockout lever 280 is at a height corresponding to the second lockout notch 224 on the firing beam 226. Furthermore, in some embodiments, a biasing spring 290 (Figure 34) exerts force on the upper surface of the distal end 282 of the lockout lever 280, tending to maintain the proximal end 286 of the lockout lever 280 at a height corresponding to the second lockout notch 224 on the firing beam 226. Thus, if a user attempts to operate the jaw assembly while a fired reload cartridge is present in the jaw assembly, the firing beam 226 advances distally until the proximal end 286 of the lockout lever 280 is accommodated within the second lockout notch 224 of the firing beam 226, indicating engagement of the fired reload lockout mechanism and preventing further distal movement of the firing beam and firing member.

[0041] Continuing to refer to Figure 18, in some embodiments, the fired reload lockout mechanism can be configured to allow operation of the stapling device's jaw assembly for at least a portion of its opening and closing stroke. For example, in some embodiments, the position of the second lockout notch 224 and the length of the lockout lever 280 can be sized and configured such that the firing beam 226 is arrested when the fired reload mechanism is engaged in a position corresponding to a fully closed or nearly fully closed configuration of the jaw assembly. In such a jaw assembly configuration, the firing member 240 maintains the cutting edge 245 in a substantially retracted position even if it advances to a distal position that brings the first and second jaws closer together. A fired reload lockout configured to allow an opening and closing stroke has the advantage that, after firing staples from a reload cartridge, the user can operate the jaw assembly for one or more opening and closing strokes to evaluate the thickness and consistency of the tissue at various positions where a potential second reload may be applied. Similarly, insertion of stapling devices through surgical access ports such as trocars may generally require the jaw assembly to be in a closed configuration, allowing the user to retract and reinsert the jaw assembly through one or more surgical access ports to evaluate the thickness and consistency of the tissue at various locations within the surgical site.

[0042] Continuing with reference to Figure 18, in some embodiments, the fired reload lockout mechanism can be further configured to prevent the operation of the stapling device during the firing stroke. Mechanical and electric stapler handle assemblies, typically configured for use with the elongated shafts and jaw assemblies described herein, such as those described with reference to Figures 1 to 5, include a firing mode selector mechanism or firing safety switch that allows the user to actively select the firing stroke operation of the jaw assembly only when the jaw assembly is in a closed configuration. Thus, in some embodiments, the position of the second lockout notch 224 and the length of the lockout lever 280 can be sized and configured such that the firing beam 226 stops when the fired reload lockout mechanism is engaged in a position corresponding to the position of the jaw assembly near the fully closed configuration. Thus, in these embodiments, when the fired reload lockout mechanism is engaged, the user can select the firing stroke operation on the handle assembly, but the handle assembly will not engage the firing beam during the firing stroke. The operation of the fired reload lockout mechanism that prevents the firing stroke operation on the handle assembly is advantageous as it serves to indicate to the user that the lockout has been engaged.

[0043] Figure 19 shows a cutaway of the proximal end of the jaw assembly with no reload cartridge inserted and the launch member and launch beam slightly advanced longitudinally. In the absence of a reload, as the tail 247 of the launch member 240 advances from the proximal end 286 of the lockout lever 280, the biasing spring 290 (Figure 12) exerts force toward the reload support on the upper surface of the distal end 282 of the lockout lever 280. Thus, when the launch beam 226 first advances in response to the user operating the handle assembly to advance the jaw assembly in an opening and closing stroke, the lockout lever 280 pivots to a first position corresponding to the locked configuration of the empty jaw assembly lockout mechanism. As the launch beam 226 advances distally, the proximal end 286 of the lockout lever 280 engages with the empty jaw assembly lockout mechanism by engaging with the first lockout notch 222 on the launch beam 226, preventing further distal translation of the launch beam 226 and the launch member 240.

[0044] Continuing to refer to Figure 19, in some embodiments, the empty jaw assembly lockout mechanism can be configured to stop the movement of the launch beam in a position corresponding to a substantially open configuration of the jaw assembly. For example, the position of the first lockout notch 222 on the launch beam 226, the length of the lockout lever 280, and the length of the tail 247 of the launch member 240 can be sized and configured such that the empty reload lockout mechanism locks in the initial part of the opening and closing stroke of the jaw assembly. Configuring the empty jaw assembly lockout mechanism to lock in the initial part of the opening and closing stroke has the advantage that the jaw assembly cannot be closed enough for the user to operate the handle assembly and insert it through the surgical access port if there is no reload cartridge in the jaw assembly. Thus, with the empty jaw assembly lockout mechanism configured in this way, the user can get tactile indication that there is no reload cartridge in the jaw assembly before accidentally introducing an empty jaw assembly to the surgical site. Furthermore, it is desirable that such an empty jaw assembly lockout maintains the cutting edge 245 of the launch member 240 in a substantially retracted protective position for jaw assemblies in which there is no reload.

[0045] Referring to Figures 20 to 27, in some embodiments, the elongated shaft and jaw assembly used in a surgical stapling device may have an independently operable empty jaw assembly lockout mechanism and a fired reload lockout mechanism. In the illustrated embodiments, the jaw assembly may include a first lockout lever and a second lockout lever that are independently operable by the corresponding first and second lockout actuators, rather than including a two-position lockout lever having surfaces operable by first and second lockout actuators as described with reference to Figures 10 to 19.

[0046] Figure 20 shows an embodiment of the launch beam 326 used in conjunction with the lockout mechanism of Figures 21 to 27. In the illustrated embodiment, the launch beam 326 includes a first lockout notch 322 and a second lockout notch 324. The first lockout notch 322 has a first height relative to the lower edge 320 of the launch beam 326, and the second lockout notch 324 has a second height relative to the lower edge 320 of the launch beam 326. In some embodiments, the second height is greater than the first height. The first lockout notch can be separated from the second lockout notch by a tab 328 that reinforces the first lockout notch. Other embodiments of the launch member 340 and the launch beam 326 are as described above with respect to the launch member and launch beam used substantially with a two-position lockout lever.

[0047] In some embodiments, Figure 21 shows a partially exploded view of the first jaw 372 and the second jaw 374 of a jaw assembly 370, with various components hidden to illustrate the empty jaw assembly lockout mechanism and the fired reload lockout mechanism. In some embodiments, the lockout mechanism includes a first empty jaw assembly lockout lever 380, a second fired reload lockout lever 480, a biasing spring 390, a first lockout notch 322, and a second lockout notch 324. In the illustrated embodiments, the first lockout lever 380 and the second lockout lever 480 are pivotably coupled to the second jaw 374 of the jaw assembly, and the first lockout lever 380 and the second lockout lever 480 are independently pivotable. In the illustrated embodiment, the first lockout lever 380 and the second lockout lever 480 are located on opposite sides of the launch member 340 and the launch beam 326, and each pivots around a pivot axis that crosses the longitudinal axis of the jaw assembly 370. In some embodiments, the first lockout lever 380 and the second lockout lever 480 pivot around the same pivot axis. In other embodiments, the pivot axis of the first lockout lever 380 may be longitudinally offset from the pivot axis of the second lockout lever 480.

[0048] Continuing to refer to Figure 21, in the illustrated embodiment, the first lockout lever 380 has a proximal end 386, a distal end 382, ​​and a pivot shaft 384 located between the proximal end 386 and the distal end 382. The biasing spring 390 has a lower spring arm 392 located on the upper surface of the distal end 382 of the first lockout lever 380. The biasing spring 390 biases the distal end 382 of the lockout lever 380 downward toward the reload support of the second jaw 374. The biasing spring may further include at least one upper spring arm 394 that biases the first jaw 372 to pivotably separate from the second jaw 374, thereby positioning the jaw assembly in an open configuration. Therefore, the biasing spring 390 exerts a spring force on the distal end 382 of the first lockout lever 380 that tends to pivot the proximal end 386 of the first lockout lever 380 upward away from the reload support. As shown in the figure, when the firing member 340 and firing beam 326 are in the fully retracted position corresponding to the open jaw assembly, the proximal tail portion 347 on the firing member 340 engages with the proximal end 386 of the first lockout lever 380, overcoming the force applied by the biasing spring 390 and positioning the distal end 382 of the first lockout lever 380 in an elevated position relative to the reload support, thereby allowing the reload cartridge to be inserted into the reload support.

[0049] Continuing to refer to Figure 21, in the illustrated embodiment, the second lockout lever 480 has a proximal end 486, a distal end 482, and a pivot shaft 484 located between the proximal end 486 and the distal end 482. In some embodiments, a biasing member 490 is located on the underside of the distal end 482 of the second lockout lever 480. The biasing member 490 is configured to maintain the distal end 482 of the second lockout lever 480 in an elevated position when no reload cartridge is present in the jaw assembly. As shown, in some embodiments, the biasing member 490 includes a compressible puck located on the underside of the distal end 482 of the second lockout lever 480, which maintains the distal end 482 of the second lockout lever 480 in an elevated position relative to the reload support. In other embodiments, other biasing members, such as a coil spring, may be located on the underside of the distal end of the second lockout lever. In yet another embodiment, the biasing member may be positioned on a reload support below the distal end of the second lockout lever.

[0050] Figures 22 and 23 show a cutaway view of the proximal end of the jaw assembly with a reload cartridge inserted, where the launch member 340 and the launch beam have advanced slightly longitudinally toward the closed configuration of the jaw assembly. Figure 22 shows the first side of the proximal end of the jaw assembly, including the first lockout lever 380. Figure 23 shows the second side of the proximal end of the jaw assembly, including the second lockout lever 480. When an unfired reload cartridge 350 is located within the jaw assembly, the empty jaw assembly lockout mechanism is deactivated and in the unlocked configuration, and the fired reload lockout mechanism is also deactivated and in the unlocked configuration.

[0051] As can be seen with reference to Figure 22, when the reload cartridge 350 is inserted into the reload support of the second jaw 374 of the jaw assembly, the first lockout actuator 352 at the proximal end of the reload 350 advances proximal between the reload support and the distal end 382 of the first lockout lever 380. In the illustrated embodiment, the first lockout actuator 352 includes a protruding surface on the reload cartridge. For example, in some embodiments, the reload cartridge may include a cartridge body partially surrounded by a metal jacket. The metal jacket may include a folding surface or a raised surface that contacts the underside of the distal end 382 of the first lockout lever 380 when the reload cartridge 350 is present in the jaw assembly, maintaining the height of the distal end 382 of the first lockout lever 380 relative to the reload support. With the distal end 382 of the first lockout lever 380 maintained at the height of the first lockout actuator 352, the proximal end 386 of the first lockout lever 380 is positioned away from the first lockout notch 322 and the second lockout notch, and at a height lower than the lower edge of the launch beam 326. Thus, when a reload cartridge 350 is present in the reload support, the empty jaw assembly lockout mechanism is disabled. In some embodiments, the lockout mechanism can be configured to allow translation of the launch beam 326 and the launch member 340 with the empty jaw lockout mechanism disabled, thereby allowing a portion of the opening and closing stroke of the jaw assembly with a reload cartridge inside, regardless of whether a reload has been fired.

[0052] As can be seen with reference to Figure 23, when the reload cartridge 350 is inserted, the proximal tail portion 354 on the slider 355 is positioned between the reload support and the lower surface of the distal end 482 of the second lockout lever 480. The biasing member 490 or compressible pack maintains the height of the distal end 482 of the second lockout lever 480, housing the tail portion 354 of the slider 355 below the distal end 482 of the second lockout lever 480. In some embodiments, the reload cartridge 350 further includes a cartridge biasing spring 492 that biases the upper surface of the distal end 482 of the second lockout lever 480 downward toward the reload support.

[0053] Continuing to refer to Figure 23, with the distal end 482 of the second lockout lever 480 maintained at the height of the tail 354 of the slider 355, the proximal end 486 of the second lockout lever 480 is located away from the first and second lockout notches and lower than the lower edge of the firing beam 326. Therefore, when a reload cartridge 350 is present in the reload support, the fired reload lockout mechanism is disabled. Thus, when an unfired reload 350 is located in the reload support of the jaw assembly, both the empty jaw assembly lockout mechanism and the fired reload lockout mechanism are disabled, and the user can operate the operably coupled handle assembly to advance the firing beam and firing member in the firing stroke and deploy the staples from the reload cartridge 350.

[0054] Figure 24 shows a cutaway of the proximal end of a jaw assembly with a partially or fully fired reloaded cartridge inserted, in which the firing member and firing beam are slightly advanced longitudinally in accordance with the closed configuration of the jaw assembly. When a partially or fully fired cartridge is present in the jaw assembly, the empty jaw assembly lockout mechanism is deactivated and in the unlocked configuration, and the fired reload lockout mechanism is in the locked configuration.

[0055] With a fired reload cartridge inserted, the position of the first lockout lever on the first side of the jaw assembly is the same as the position described above for an unfired reload cartridge (Figure 22). Therefore, when a reload cartridge is fired at least partially, or when a previously used reload cartridge is reinserted into the reload support of the jaw assembly, the empty jaw assembly lockout mechanism is deactivated.

[0056] Referring to Figure 24, with the fired reload cartridge 350 inserted, the cartridge biasing spring exerts a downward force toward the reload support on the distal end 482 of the second lockout lever 480. The cartridge biasing spring 492 is configured to exert a force sufficient to overcome the biasing force of the biasing member 490 between the reload support and the second lockout lever 480. In some embodiments, the cartridge biasing spring 492 is coupled to the reload cartridge 350 at its proximal end. In the illustrated embodiment, the slider tail is not in the proximal position, and the cartridge biasing spring 492 exerts a force sufficient to press the compressible pack against the underside of the distal end 482 of the second lockout lever 480, causing the distal end 482 of the second lockout lever 480 to pivot to a relatively low height relative to the reload support. With the distal end 482 of the second lockout lever 480 in this relatively low position, the fired reload lockout mechanism is locked because the proximal end 486 of the second lockout lever 480 is positioned at a height corresponding to the second lockout notch 324 of the firing beam 326. As shown in the figure, when the firing beam moves forward by the user attempting to operate the jaw assembly in an opening and closing stroke, the proximal end 486 of the second lockout lever 480 engages with the second lockout notch 324 of the firing beam 326, stopping the firing beam 326 from moving further longitudinally distally, thus engaging the fired reload lockout mechanism.

[0057] Continuing to refer to Figure 24, in the illustrated embodiment, the fired reload lockout mechanism is configured to allow a certain range of movement of the jaw assembly during the opening and closing stroke in response to user input in the handle assembly. For example, the position of the proximal end of the second lockout lever and the second lockout notch can be selected to result in engagement of the fired reload lockout mechanism at the position of the firing beam corresponding to a closed or nearly closed configuration of the jaw assembly. Thus, the user has the advantage of being able to grasp tissue with the jaw assembly and evaluate tissue thickness and consistency without moving the stapling device from the surgical site after firing staples from the reload cartridge. Furthermore, the fired reload lockout mechanism can be configured to prevent the user from selecting the firing action in the handle assembly of the stapling device by engaging before the opening and closing stroke of the jaw assembly is completed. Thus, it is possible to prevent the user from inadvertently advancing the firing member and firing beam to a position corresponding to the firing stroke of the jaw assembly where the cutting edge of the firing beam may reach the tissue.

[0058] Figures 25, 26, and 27 show cutaway views of the proximal end of a jaw assembly corresponding to the open configuration of the jaw assembly, where no reload cartridge is inserted and the launch member and launch beam are fully retracted longitudinally (Figures 25 and 27), or substantially fully retracted (Figure 26). Figure 25 shows the first side of the proximal end of the jaw assembly, including the first lockout lever 380. Figure 26 shows the first side of the proximal end of the jaw assembly with the launch member slightly advanced, illustrating the operation of the empty jaw assembly lockout mechanism. Figure 27 shows the second side of the proximal end of the jaw assembly, including the second lockout lever 480. In the illustrated embodiment, no reload cartridge is located within the jaw assembly, the empty jaw assembly lockout mechanism is in a locked configuration, and the fired reload lockout mechanism is in an unlocked configuration.

[0059] Referring to Figure 25, when the jaw assembly is in the open configuration with no reload cartridge inserted, the position of the first lockout lever 380 is initially maintained such that the distal end 382 of the first lockout lever 380 is raised from the reload support to accommodate the reload cartridge. When the jaw assembly is in the open configuration, the launch beam 326 is in the fully retracted position, and the tail 347 on the launch member 340 is located on the proximal end 386 of the first lockout lever 380, positioning the distal end 382 of the first lockout lever 380 to accommodate the reload cartridge. However, if the user attempts to operate the jaw assembly in the opening and closing stroke (Figure 26), the tail 347 on the launch member 340 moves longitudinally forward away from the proximal end 386 of the first lockout lever 380. The biasing spring 390 can pivot the first lockout lever 380 by applying force to the upper surface of the distal end 382 of the first lockout lever 380, thereby positioning the proximal end 386 of the first lockout member at a height from the reload support corresponding to the height of the first lockout notch 322 on the launch beam 326. Referring to Figure 26, if the user continues to attempt to operate the jaw assembly in the opening and closing stroke, the proximal end 386 of the first lockout lever 380 will engage with the first lockout notch 322 on the launch beam 326 during the initial distal movement of the launch beam. Thus, the empty jaw assembly lockout mechanism becomes locked.

[0060] Continuing to refer to Figures 25-26, the empty jaw assembly lockout mechanism can be configured to restrict further distal movement of the launch beam during the initial portion of the jaw assembly's opening and closing stroke. For example, the size of the tail portion 347 on the launch member 340, the position of the proximal end 386 of the first lockout lever 380, and the first lockout notch 322 can be configured to stop the launch beam 326 during its initial distal movement. Thus, the empty jaw assembly lockout mechanism engages with the jaw assembly in a partially or substantially open configuration. This engagement of the empty jaw assembly lockout mechanism is desirable to indicate to the user that the jaw assembly is empty before it is introduced into the surgical site.

[0061] Referring to Figure 27, when no reload cartridge is inserted into the jaw assembly, the biasing member 490 or compressible pack maintains the distal end 482 of the second lockout lever 480 in an elevated position relative to the reload support. With the distal end 482 of the second lockout lever 480 in this elevated position, the proximal end 486 of the second lockout lever 480 is positioned adjacent to the reload support at a relatively low height, spaced apart from the first and second lockout notches of the firing beam 326. Thus, the fired reload lockout mechanism is in an unlocked configuration. As shown in the figure, when the firing beam moves forward by the user attempting to operate the jaw assembly in an opening and closing stroke, the fired reload lockout mechanism remains in an unlocked configuration, and the proximal end of the second lockout lever remains adjacent to the reload support.

[0062] While this application discloses several preferred embodiments and examples, those skilled in the art will understand that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, obvious modifications and equivalents. Furthermore, various features of these inventions can be used individually or in combination with other features of these inventions not explicitly described above. Accordingly, the scope of the present invention as disclosed herein should not be limited by the specific disclosed embodiments described above, but should be determined solely by a fair reading of the following claims. [Explanation of Symbols]

[0063] 222 First lockout notch 224 Second lockout notch 226 Launch beam 240 launching components 270 Jaw Assembly 272 The First Joe 274 The Second Joe 280 Lockout Lever 281 Inner surface 282 Distal end 283 Lateral extension 284 Pivot axis 286 Proximal end 290 biasing spring 292 Lower spring arm 294 Upper spring arm

Claims

1. It is a surgical stapler, An elongated shaft having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, A launch beam having a proximal end and a distal end, at least a portion of which is slidable longitudinally within the elongated shaft, and including a first notch and a second notch formed inside, The launching member at the distal end of the launching beam, The jaw assembly at the distal end of the elongated shaft, The jaw assembly is equipped with, The first Joe who sets up the anvil, A second jaw defines a reload support configured to house the reload cartridge having multiple staples that can be deployed from the reload cartridge, A first lockout lever pivotably connected to the second jaw, having a proximal end, a distal end, and a pivot axis between the proximal and distal ends, A second lockout lever pivotably connected to the second jaw, having a proximal end, a distal end, and a pivot axis between the proximal end and the distal end, Includes, The first lockout lever is pivotable between a first position in which the proximal end of the first lockout lever is at a first height spaced apart from the first notch, and a second position in which the proximal end of the first lockout lever is at a second height corresponding to the position of the first notch, wherein the first lockout lever defines an empty jaw assembly lockout mechanism, which has a lock configuration defined by the second position of the first lockout lever when no reload cartridge is present in the reload support, and in this lock configuration, the proximal end of the first lockout lever is configured to engage with the first notch to restrict further distal movement of the firing beam. The second lockout lever is pivotable between a first position in which the proximal end of the second lockout lever is at a first height spaced apart from the second notch, and a second position in which the proximal end of the second lockout lever is at a second height corresponding to the position of the second notch, wherein the second lockout lever defines a fired reload lockout mechanism, which has a lock configuration defined by the second position of the second lockout lever when a fired reload cartridge is located within the reload support, and in this lock configuration, the proximal end of the second lockout lever is configured to engage with the second notch to restrict further distal movement of the firing beam. A surgical stapler characterized by the following features.

2. The device further comprises a spring that biases the distal end of the first lockout lever toward the reload support. The surgical stapler according to claim 1.

3. The second lockout lever includes a biasing member positioned on the lower surface of the distal end of the second lockout lever. The surgical stapler according to claim 1.

4. The reload cartridge is further removably disposed within the reload support, and the reload cartridge includes a first lockout actuator disposed to engage with the distal end of the first lockout lever to maintain the first lockout lever in the first position when the reload cartridge is disposed within the reload support, and a second lockout actuator disposed to engage with the distal end of the second lockout lever to position the second lockout lever in the first position when the reload cartridge in the reload support is not fired. The surgical stapler according to claim 1.

5. The reload cartridge includes a cartridge body and a cartridge jacket that partially surrounds the cartridge body, and the first lockout actuator includes a protrusion formed within the cartridge jacket. The surgical stapler according to claim 4.

6. The reload cartridge includes a plurality of staples located within the reload cartridge and a slider that is longitudinally slidable within the reload cartridge from a proximal position to a distal position to deploy the plurality of staples, wherein the slider includes a tail portion extending in the proximal direction that defines the second lockout actuator when the slider is in the proximal position. The surgical stapler according to claim 4.

7. The reload cartridge further includes a cartridge spring, the cartridge spring being positioned such that the distal end of the second lockout lever is biased toward the reload support when the slider moves distally from the proximal position, so that the second lockout lever is in the second position. The surgical stapler according to claim 6.

8. It is a surgical stapler, An elongated shaft having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, A launch beam having a proximal end and a distal end, at least a portion of which is slidable longitudinally within the elongated shaft, and including a first notch and a second notch formed inside, The launching member at the distal end of the launching beam, The jaw assembly at the distal end of the elongated shaft, The jaw assembly is equipped with, The first Joe who sets up the anvil, A second jaw defines a reload support configured to house the reload cartridge having multiple staples that can be deployed from the reload cartridge, A lockout lever pivotably connected to the second jaw, having a proximal end, a distal end, and a pivot axis between the proximal end and the distal end, Includes, The aforementioned lockout lever is A first position is where the proximal end of the lockout lever is at a first height corresponding to the first notch, the first position defines an empty jaw assembly lockout mechanism, the empty jaw assembly lockout mechanism having a lock configuration defined by the first position of the lockout lever when no reload cartridge is present in the reload support, the lock configuration in which the proximal end of the lockout lever is configured to engage with the first notch to restrict further distal movement of the firing beam, The second position is such that the proximal end of the lockout lever is at a second height corresponding to the position of the second notch, and the second position defines a fired reload lockout mechanism, which has a lock configuration defined by the second position of the lockout lever when a fired reload cartridge is located within the reload support, and in this lock configuration, the proximal end of the lockout lever is configured to engage with the second notch to restrict the further distal movement of the firing beam. The proximal end of the lockout lever is located at a third height spaced apart from the first and second notches, and is pivotable between an unlocked position that allows distal movement of the firing beam, and an unlocked position in which an unfired reload cartridge is located within the reload support, and the empty jaw assembly lockout mechanism and the fired reload lockout mechanism are disabled. A surgical stapler characterized by the following features.

9. The reload cartridge further comprises a reload cartridge that can be removably disposed within the reload support. The surgical stapler according to claim 8.

10. The reload cartridge includes an inclined boss protruding from the reload cartridge, the inclined boss being arranged to engage the distal end of the lockout lever with the reload cartridge located within the reload support, The engagement of the distal end of the lockout lever with the inclined boss causes the lockout lever to pivot to the second position. The surgical stapler according to claim 9.

11. The reload cartridge further includes a plurality of staples located within the reload cartridge, and a slider that can slide longitudinally within the reload cartridge from a proximal position to a distal position to deploy the plurality of staples from the reload cartridge. The surgical stapler according to claim 10.

12. The slider includes a tail portion extending proximal to the slider, and the tail portion is configured to engage with the distal end of the lockout lever when the reload cartridge is located within the reload support and the slider is in the proximal position. The engagement of the distal end and tail of the lockout lever causes the lockout lever to pivot to the unlocked position as an unfired reload cartridge is inserted into the reload support. The surgical stapler according to claim 11.

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