Surgical staple fastening device with firing lockout mechanism

Abstract

The surgical stapling device includes a tool assembly and a drive assembly for actuating the tool assembly. The tool assembly includes a cartridge assembly having a staple cartridge and an anvil assembly supporting a lockout mechanism. The staple cartridge includes a cartridge body and an actuation sled and knife assembly including an actuation sled and a knife. The actuation sled and knife assembly is movable relative to the cartridge body to eject staples from the cartridge body and sever tissue. The anvil assembly supports a lockout mechanism including a lockout member movable between a locked position and an unlocked position. The drive assembly is movable from a retracted position to an advanced position to move the actuation sled and knife assembly from its retracted position to its advanced position.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a surgical stapling device having a staple cartridge, and more particularly, to a surgical stapling device having a lockout mechanism that prevents firing of the stapling device when a knife is not present in the staple cartridge.

BACKGROUND ART

[0002] Surgical stapling devices for simultaneously stapling and cutting tissue are well known in the art and include a tool assembly and a drive assembly. The tool assembly includes an anvil assembly and a cartridge assembly having a channel member and a staple cartridge received within the channel member. Typically, the staple cartridge includes a cartridge body that supports staples, pushers, and an actuation sled. The actuation sled is movable through the cartridge body from a retracted position to an advanced position and sequentially engages the pushers to sequentially eject staples from the cartridge body.

[0003] In some stapling devices, a knife is supported on the actuation sled and is movable with the actuation sled through the cartridge body. The drive assembly is positioned proximal to the actuation sled, and is movable relative to the anvil assembly and the cartridge assembly to advance the actuation sled and the knife through the staple cartridge, move the tool assembly between an open position and a clamped position, eject staples from the cartridge body, and cut tissue clamped between the anvil assembly and the cartridge assembly. After the stapling device is fired, the actuation sled and the knife remain in the distal portion of the staple cartridge.

[0004] When a stapling device is fired with a staple cartridge that does not have an operating thread and / or knife present in the proximal portion of the staple cartridge, the staples are not ejected from the staple cartridge and the tissue is not cut. A simple locking mechanism is still needed that can prevent the drive assembly of the stapling device from advancing through the staple cartridge when the thread and / or knife is not present in the proximal portion of the staple cartridge. [Overview of the project] [Means for solving the problem]

[0005] This disclosure relates to a stapling device having a tool assembly including a cartridge assembly, an anvil assembly, and a drive assembly. The anvil assembly supports a lockout mechanism, which prevents the drive assembly from advancing when the cartridge assembly does not have an actuating thread or knife present in the proximal portion of the cartridge assembly.

[0006] Aspects of this disclosure relate to a surgical stapling device comprising an elongated body, a tool assembly, and a drive assembly. The elongated body has a proximal and a distal portion. The tool assembly includes a cartridge assembly and an anvil assembly supported on the distal portion of the elongated body and coupled to each other to facilitate movement of the tool assembly between an open position and a clamped position. The cartridge assembly includes a staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly. The actuating thread and knife assembly includes an actuating thread and a knife supported on the actuating thread for movement between an elevated position and a lowered position. The actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject staples from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly. The anvil assembly includes a lockout mechanism that is linearly movable from a locked position to an unlocked position. The actuating thread and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the actuating thread and knife assembly is in its retracted position. The drive assembly is positioned proximal to the actuating thread and knife assembly and is movable relative to the tool assembly between the retracted and advanced positions to move the tool assembly between the open and clamped positions, and to move the actuating thread and knife assembly from its retracted position to its advanced position. The lockout mechanism is positioned to prevent the drive assembly from moving from its retracted position to its advanced position when the lockout mechanism is in its locked position.

[0007] In aspects of this disclosure, the lockout mechanism includes a lockout member that is movable between a locked position and an unlocked position.

[0008] In some aspects of the present disclosure, the lockout mechanism includes a biasing member positioned to bias a biasing member to a locked position.

[0009] In one embodiment of the present disclosure, an anvil plate supporting a housing that defines an opening is included, and a lockout member and a biasing member are positioned within the housing.

[0010] In embodiments of this disclosure, the lockout member is movable through an opening in the housing between a locked position and an unlocked position.

[0011] In some aspects of the present disclosure, the anvil assembly includes an anvil plate defining a central knife slot defining a longitudinal axis, and a lockout member extends over at least a portion of the central knife slot when the lockout member is in the locked position.

[0012] In certain aspects of the present disclosure, the drive assembly includes a clamping member in the form of an I-beam, and includes an operating member having a first beam, a second beam, and a vertical support connecting the first beam to the second beam.

[0013] In aspects of this disclosure, the vertical support is positioned to translate through the central knife slot of the anvil plate as the drive assembly moves between its retracted and advanced positions.

[0014] In some aspects of the present disclosure, the lockout member has a distally facing cam surface that defines a plane forming an acute angle with the longitudinal axis of the central knife slot of the anvil plate.

[0015] In certain embodiments of the present disclosure, as the drive assembly moves from a forward position to a retracted position, moving the lockout member from a locked position to an unlocked position, the distally facing cam surface engages with the vertical support of the drive assembly.

[0016] In embodiments of this disclosure, the lockout member includes a proximal-facing stop surface that defines a plane substantially perpendicular to the longitudinal axis of the central knife slot of the anvil plate.

[0017] In some aspects of the present disclosure, the knives of the actuating thread and knife assembly are positioned to engage with the lockout member when the actuating thread and knife assembly is in a retracted position to hold the lockout member in an unlocked position.

[0018] Other aspects of the present disclosure relate to a tool assembly including a cartridge assembly, an anvil assembly, and a lockout mechanism. The cartridge assembly includes a staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly. The actuating thread and knife assembly includes an actuating thread and a knife supported on the actuating thread for movement between an elevated position and a lowered position. The actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject staples from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly. The anvil is coupled to the cartridge assembly to facilitate movement of the tool assembly between an open position and a clamped position. A lockout mechanism is supported on the anvil assembly and is linearly movable from a locked position to an unlocked position. The actuating thread and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the actuating thread and knife assembly is in its retracted position.

[0019] Yet another aspect of the present disclosure relates to a tool assembly including a cartridge assembly, an anvil assembly, and a lockout mechanism. The cartridge assembly includes a staple cartridge having a cartridge body, staples, a pusher, and an actuation sled and knife assembly. The actuation sled and knife assembly includes an actuation sled and a knife. The actuation sled and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject staples from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly. The anvil is coupled to the cartridge assembly to facilitate movement of the tool assembly between an open position and a clamping position. The lockout mechanism is supported on the anvil assembly and is linearly movable from a locked position to an unlocked position. The actuation sled and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the actuation sled and knife assembly is in its retracted position.

[0020] Other features of the present disclosure will be understood from the following description. The present invention provides, for example, the following: (Item 1) A surgical staple fastening device, An elongated body having a proximal portion and a distal portion, A tool assembly supported on the distal portion of the elongated body, wherein the tool assembly includes a cartridge assembly and an anvil assembly coupled to each other to facilitate movement of the tool assembly between an open position and a clamped position, the cartridge assembly includes a staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly, the actuating thread and knife assembly includes an actuating thread and a knife supported on the actuating thread for movement between an elevated position and a lowered position, the actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject the staples from the cartridge body to cut tissue clamped between the cartridge assembly and the anvil assembly, the anvil assembly includes a lockout mechanism that is linearly movable from a locked position to an unlocked position, and the actuating thread and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the actuating thread and knife assembly is in its retracted position, A drive assembly positioned proximal to the operating thread and knife assembly, the drive assembly being movable relative to the tool assembly between a retracted position and a forward position so as to move the tool assembly between the open position and the clamped position, and move the operating thread and knife assembly from its retracted position to its forward position, comprising: A surgical stapling device wherein the lockout mechanism is positioned to prevent the drive assembly from moving from its retracted position to its forward position when the lockout mechanism is in its locked position. (Item 2) The surgical stapling device according to item 1, wherein the lockout mechanism includes a lockout member that is movable between the locked position and the unlocked position. (Item 3) The surgical stapling device according to item 2, wherein the lockout mechanism includes a biasing member positioned to bias the lockout member to the locked position. (Item 4) The surgical stapling device according to item 3, wherein the anvil assembly includes an anvil plate supporting a housing that defines an opening, and the lockout member and the biasing member are positioned within the housing. (Item 5) The surgical stapling device according to item 4, wherein the lockout member is movable through the opening in the housing between the locked position and the unlocked position. (Item 6) The surgical stapling device according to item 2, wherein the anvil assembly includes an anvil plate defining a central knife slot defining a longitudinal axis, and the lockout member extends over at least a portion of the central knife slot when the lockout member is in the locked position. (Item 7) The surgical stapling device according to item 6, wherein the drive assembly includes an operating member having an I-beam configuration, the operating member having a first beam, a second beam, and a vertical support connecting the first beam to the second beam, the vertical support being positioned to translate through the central knife slot of the anvil plate as the drive assembly moves between its retracted and advanced positions. (Item 8) The surgical stapling device according to item 7, wherein the lockout member has a distally facing cam surface defining a plane, the plane defining an acute angle with the longitudinal axis of the central knife slot of the anvil plate, and the distally facing cam surface engages with the vertical support of the drive assembly as the drive assembly is moved from the forward position to its retracted position to move the lockout member from the locked position to the unlocked position. (Item 9) The surgical stapling device according to item 2, wherein the lockout member includes a proximal-facing stop surface that defines a plane substantially perpendicular to the longitudinal axis of the central knife slot of the anvil plate. (Item 10) The surgical stapling device according to item 9, wherein the knife of the actuating thread and knife assembly is positioned to engage with the lockout member when the actuating thread and knife assembly is in a retracted position to hold the lockout member in the unlocked position. (Item 11) A tool assembly, A cartridge assembly comprising a staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly, wherein the actuating thread and knife assembly includes an actuating thread and a knife supported on the actuating thread for movement between an elevated position and a lowered position, and the actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject the staples from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly, To facilitate the movement of the tool assembly between the open position and the clamped position, an anvil assembly is coupled to the cartridge assembly, A tool assembly comprising: a lockout mechanism supported on the anvil assembly, wherein a lockout member is linearly movable from a locked position to an unlocked position, and the working thread and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the working thread and knife assembly is in its retracted position. (Item 12) The tool assembly according to item 11, wherein the lockout mechanism includes a lockout member that is movable between the locked position and the unlocked position. (Item 13) The tool assembly according to item 12, wherein the lockout mechanism includes a biasing member positioned to bias the biasing member to the locked position. (Item 14) The tool assembly according to item 13, wherein the anvil assembly includes an anvil plate supporting a housing that defines an opening, and the lockout member and the biasing member are positioned within the housing. (Item 15) The tool assembly according to item 14, wherein the lockout member is movable through the opening in the housing between the locked position and the unlocked position. (Item 16) The tool assembly according to item 12, wherein the anvil assembly includes an anvil plate defining a central knife slot defining a longitudinal axis, and the lockout member extends over at least a portion of the central knife slot when the lockout member is in the locked position. (Item 17) The tool assembly according to item 16, wherein the lockout member has a distally facing cam surface defining a plane, the plane defining an acute angle with the longitudinal axis of the central knife slot of the anvil plate. (Item 18) The tool assembly according to item 17, wherein the lockout member includes a proximal-facing stop surface that defines a plane substantially perpendicular to the longitudinal axis of the central knife slot of the anvil plate. (Item 19) The tool assembly according to item 18, wherein the knife of the actuating thread and knife assembly is positioned to engage with the lockout member when the actuating thread and knife assembly is in the retracted position in order to hold the lockout member in the unlocked position. (Item 20) A tool assembly, A cartridge assembly comprising a staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly, wherein the actuating thread and knife assembly includes an actuating thread and a knife, and the actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject the staples from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly, To facilitate the movement of the tool assembly between the open position and the clamped position, an anvil assembly is coupled to the cartridge assembly, A tool assembly comprising: a lockout mechanism supported on the anvil assembly, wherein a lockout member is linearly movable from a locked position to an unlocked position, and the working thread and knife assembly is positioned to bias the lockout mechanism to its unlocked position when the working thread and knife assembly is in its retracted position.

[0021] Various aspects of this disclosure are described below herein with reference to the drawings. [Brief explanation of the drawing]

[0022] [Figure 1] This is a side perspective view of a surgical stapling device according to an aspect of the present disclosure, including a tool assembly in the open position.

[0023] [Figure 2] Figure 1 shows a side perspective view of the tool assembly of a surgical stapling device, with the cartridge assembly separated from the channel member of the tool assembly.

[0024] [Figure 3] Figure 2 shows a magnified view of the detailed area displayed, which represents the proximal portion of the anvil assembly.

[0025] [Figure 4] Figure 2 is a side perspective exploded view of the operating thread and knife assembly of the staple cartridge shown.

[0026] [Figure 5] Figure 2 is an exploded perspective view of the staple cartridge in the cartridge assembly shown.

[0027] [Figure 5A] Figure 5 is a side perspective exploded view of the operating thread and knife assembly of the staple cartridge shown.

[0028] [Figure 6] Figure 2 is a side perspective view of the anvil assembly of the tool assembly shown.

[0029] [Figure 7] This is an enlarged view of the detailed area shown in Figure 6, illustrating the lockout mechanism.

[0030] [Figure 8] Figure 7 is a side perspective view of the lockout member of the lockout mechanism shown.

[0031] [Figure 9] Figure 7 is a top perspective view of the lockout member of the lockout mechanism shown.

[0032] [Figure 10] Figure 6 is a top view of the proximal portion of the anvil assembly shown.

[0033] [Figure 11] Figure 10 is an enlarged view of the displayed detail area.

[0034] [Figure 12] Figure 1 is a first side view of the distal portion of the drive assembly of the staple fastening device shown.

[0035] [Figure 13] Figure 12 is a second side cross-sectional perspective view of the distal portion of the drive assembly shown.

[0036] [Figure 14] Figure 2 is an enlarged view of the detailed area shown.

[0037] [Figure 15] Figure 1 is a side perspective view of the proximal portion of the tool assembly of the staple fastening device, where the anvil assembly and cartridge assembly are shown by dashed lines as the working member of the drive assembly is advanced from the retracted position to the position that moves the tool assembly to the clamping position.

[0038] [Figure 16] This is a schematic diagram showing the positions of the lockout mechanism, the working members of the drive assembly, and the knife of the working thread and knife assembly before the knife engages with the lockout mechanism.

[0039] [Figure 17]This is a side perspective view of the working member of the drive assembly and the working thread and knife assembly when the drive assembly lifts the knife of the working thread and knife assembly from the lowered position to the raised position.

[0040] [Figure 18] This is a schematic diagram showing the lockout mechanism, the working members of the drive assembly, and the position of the knife in the operating thread and knife assembly, where the knife engages with the lockout mechanism, moving the lockout mechanism from the locked position to the unlocked position.

[0041] [Figure 19] This is a top view of the proximal portion of the anvil assembly and the drive assembly, showing the drive assembly returning to its retracted position after the staple fastening device has been fired, with the lockout mechanism held in the unlocked position by the drive assembly.

[0042] [Figure 20] This is a top view of the proximal and distal portions of the anvil assembly, indicated by dashed lines, with the drive assembly in its retracted position and the lockout mechanism in the locked position. [Modes for carrying out the invention]

[0043] The surgical stapling devices disclosed herein will be described in detail with reference to the drawings, where similar reference numerals in the drawings indicate the same or corresponding elements in each of the multiple figures. However, it should be understood that the embodiments of this disclosure are merely illustrative and can be embodied in various forms. To avoid ambiguity of this disclosure due to unnecessary detail, well-known functions or configurations are not described in detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limitations, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to employ this disclosure in various forms in substantially any appropriately detailed configuration.

[0044] In this description, the term “proximal” is generally used to refer to the part of the device closer to the clinician when using the stapled device in the usual manner, and the term “distal” is generally used to refer to the part of the device further away from the clinician when using the stapled device in the usual manner. In addition, the term “clinician” is generally used to refer to healthcare professionals, including physicians, nurses, and support staff. Furthermore, directional terms such as anterior, posterior, superior, inferior, upper, bottom, and similar terms are used to aid in understanding the description and are not intended to limit this disclosure.

[0045] The disclosed surgical stapling device includes a tool assembly and a drive assembly for acting on the tool assembly. The tool assembly includes a cartridge assembly having a staple cartridge and an anvil assembly supporting a lockout mechanism. The staple cartridge includes a cartridge body and an actuating thread and knife assembly including an actuating thread and knife. The actuating thread and knife assembly is movable relative to the cartridge body to eject staples from the cartridge body and cut tissue. The anvil assembly supports a lockout mechanism including a lockout member that is linearly movable between a locked position and an unlocked position. The drive assembly is movable from a retracted position to an advanced position to move the actuating thread and knife assembly from its retracted position to its advanced position. In the locked position, the lockout member prevents the drive assembly from moving from the retracted position to the advanced position.

[0046] Figure 1 shows a surgical staple device according to an aspect of the present disclosure, generally referred to as staple device 10. Staple device 10 includes a handle assembly 12, an elongated body 14, and a tool assembly 16. The elongated body 14 defines a longitudinal axis "X" (Figure 1). The handle assembly 12 includes a body 18 defining a handgrip 18a, an actuator button 20, and a rotary knob 22. The rotary knob 22 is rotatably supported on the distal portion of the body 18 of the handle assembly 12 and supports the elongated body 14 to facilitate rotation of the elongated body 14 and the tool assembly 16 relative to the handle assembly 12 about the longitudinal axis "X". The actuator button 20 controls the operation of various functions of staple device 10, including articulation of tissue, clamping, firing, and cutting.

[0047] The tool assembly 16 includes an anvil assembly 24 and a cartridge assembly 26, which are coupled together to facilitate the movement of the tool assembly 16 between an open position and a clamped position. Although the stapling device 10 is shown as an electrically operated stapling device, it is assumed that the tool assembly 16 of this disclosure may also be suitable for use in manually operated surgical stapling devices and robotically operated stapling systems. U.S. Patent No. 9,055,943 discloses a surgical stapling device including a powered handle assembly, U.S. Patent No. 6,241,139 discloses a surgical stapling device including a manually operated handle assembly, and U.S. Patent No. 9,962,159 discloses a stapling device configured for use with a robotic system.

[0048] Figures 2 to 5 show a cartridge assembly 26 (Figure 1) including a staple cartridge 28 and a channel member 30 defining a recess 30a for receiving the staple cartridge 28. In embodiments of this disclosure, the staple cartridge 28 is removably supported within the recess 30a of the channel member 30 and is replaceable to facilitate the reuse of the stapling device 10.

[0049] The staple cartridge 28 includes a cartridge body 32, an actuating thread and knife assembly 34 (Figure 4), a pusher 36 (Figure 5), staples 38 (Figure 5), and a base plate 40. The cartridge body 32 defines a central knife slot 42 and staple receiving pockets 44. In embodiments of this disclosure, the staple receiving pockets 44 are aligned in rows positioned on each side of the central knife slot 42. Although three rows of staple receiving pockets 44 are shown on each side of the central knife slot 42, it is assumed that the cartridge body 32 may define one or more rows of staple receiving pockets 44 on each side of the central knife slot 42. Each staple receiving pocket 44 receives one of the staples 38 and one of the pushers 36. The pusher 36 supports the staple 38 and engages with the actuating thread 34a of the actuating thread and knife assembly 34 as the actuating thread and knife assembly 34 advances through the cartridge body 32 and ejects the staple 38 from the cartridge body 32. The base plate 40 is fixed to the bottom of the cartridge body 32 and prevents the pusher 36 and staples 38 from falling off the cartridge body 32 before the staple fastening device 10 (Figure 1) is fired.

[0050] Figures 4 to 5A show the actuator thread and knife assembly 34 (Figure 5A), which includes the actuator thread 34a, the knife 66, and the biasing member 68 (Figure 5A). The actuator thread 34a supports the knife 66 and is movable from a retracted position to a forward position within the cartridge body 32 (Figure 5). The actuator thread 34a includes a body 50 (Figure 5A) having a central portion 52 and cam surfaces 54 positioned on both sides of the central portion 52 of the body 50. The cam surfaces 54 define inclined surfaces positioned to engage with the pusher 36 as the actuator thread 34a moves from its retracted position to its forward position, sequentially ejecting the staples 38 from the cartridge body 32.

[0051] The central portion 52 of the operating thread 34a supports the knife 66 and includes spaced walls 56 and a housing 58. Each of the spaced walls 56 defines a circular recess 60 (Figure 5A). The housing 58 extends distally along the longitudinal axis defined by the spaced walls 56 and is positioned between the longitudinal axes. The housing 58 defines a recess 62 that aligns with the central knife slot 42 of the cartridge body 32.

[0052] The knife 66 has a Z-shaped configuration and a body 70 including an elongated arm 72, a first portion 74 extending downward from the distal end of the elongated arm 72, and a second portion 76 extending upward from the proximal end of the elongated arm 72. The first portion 74 of the body 70 of the knife 66 supports a pivot member 78 that is received in a circular recess 60 in spaced-out walls 56 of the actuating thread 34a, so that the knife 66 is pivotably supported on the actuating thread 34a between an elevated position and a lowered position. In the elevated position of the knife 66, the first portion 74 of the body 70 of the knife 66 is received in a recess 62 in the housing 58 of the central portion 52 of the actuating thread 34a. A second portion 76 of the body 70 of the knife 66 defines a distally facing cutting edge 80 that is concealed within the central knife slot 42 of the cartridge body 32 when the knife 66 is in the lowered position and extends above the central knife slot 42 when the knife 66 is in the raised position. The body 70 of the knife 66 also includes a projection 82 that extends laterally from an elongated arm 72. In embodiments of this disclosure, the projection 82 is positioned on the proximal portion of the elongated arm 72 of the knife 66.

[0053] The biasing member 68 of the actuating thread and knife assembly 34 is received in a recess 62 of the housing 58 of the central portion 52 of the actuating thread 34a and engages with a first portion 74 of the body 70 of the knife 66 at a position above the axis defined by the pivot member 78 of the knife 66, thereby biasing the knife 66 toward the downward position. In embodiments of this disclosure, the biasing member 68 includes a coil spring, but it is conceivable that other types of biasing mechanisms or members may be used instead of a coil spring.

[0054] Figures 6 and 7 show an anvil assembly 24 including an anvil cover 90 and an anvil plate 92. The anvil cover 90 includes a mounting portion 94 and a cover portion 96 (Figure 15) that extends distally from the mounting portion 94 along the anvil plate 92. The mounting portion 94 includes a spaced-out extension portion 98 that defines a bore 100 and extends downward from the anvil plate 92 toward the channel 30 of the cartridge assembly 26. The anvil plate 92 includes a tissue engagement surface 102 that is juxtaposed with the staple cartridge 28 when the tool assembly 16 is in the clamped position (Figure 1). The tissue engagement surface 102 defines a plurality of staple deformation recesses 104. The distal edge of the spaced-out extension portion 98 defines a tissue stop portion 98a that is positioned slightly distal to the nearest staple deformation recess 104. The anvil plate 92 has a side opposite to the tissue engagement surface 102 that defines an elongated recess 91 (Figure 16). The anvil cover 90 is fixed to the anvil plate 92, for example by welding or crimping, such that the cover portion 96 (Figure 15) of the anvil cover 90 surrounds the elongated recess 91 of the anvil plate 92 and defines a channel 93 (Figure 16) within the anvil assembly 24. The anvil plate 92 also extends through the tissue engagement surface 102 of the anvil plate 92 and defines a central knife slot 108 that communicates with an elongated recess (not shown) of the anvil plate 92.

[0055] A bore 100 within the extension 98 of the anvil cover 90 receives a pivot member 112 (Figure 2), which extends through the bore 100 into a bore (not shown) defined within the proximal portion of the channel member 30 (Figure 2), thereby pivotably securing the anvil assembly 24 to the cartridge assembly 26. In embodiments of this disclosure, the cartridge assembly 26 can pivot toward the anvil assembly 24 between an open position and a clamped position. It is also conceivable that the tool assembly 16 (Figure 2) may be configured to pivot toward the cartridge assembly 26.

[0056] The anvil assembly 24 includes a lockout mechanism 114 (Figure 7) shown in Figures 6 to 11, which is supported on the anvil plate 92 between the extensions 98 of the mounting portion 94 of the anvil assembly 24, proximal to the tissue engagement surface 102 of the anvil plate 92. In an embodiment of this disclosure, the lockout mechanism 114 is supported on the outer surface 102a of the anvil plate 92 adjacent to the tissue engagement surface 102 of the anvil plate 92. The lockout mechanism 114 includes a lockout member 116 and a biasing member 118. The lockout member 116 is housed in a housing 120 fixed to the surface 102a of the anvil plate 92 and defines a cavity 122. In an embodiment of this disclosure, the housing 120 has a rectangular configuration and defines an opening 124 (Figure 7) facing a central knife slot 108.

[0057] The lockout member 116 includes a body 125 having a first end that is received within a cavity 122 of the housing 120 supported on the anvil plate 92 of the anvil assembly 24, and a second end that extends laterally through an opening 124 of the housing 120 toward the central knife slot 108 of the anvil assembly 24. The first end portion of the body 125 of the lockout member 116 supports wings 128 that extend distally and proximal from the body 125. The wings 128 extend from the body 125 within the cavity 122 defined by the housing 120 to prevent the lockout member 116 from passing through the opening 124 completely. In the locked position of the lockout mechanism 114, the wings 128 engage with the inner wall 120a (Figure 11) of the housing 120 that defines the opening 124. The second end portion of the body 125 of the lockout member 116 includes a distally facing cam surface 126 and a proximal facing stop surface 127. The distally facing cam surface 126 defines a plane that forms an acute angle with the longitudinal axis defined by the central knife slot 108 of the anvil plate 92. The proximal facing stop surface 127 defines a plane that is substantially perpendicular to the longitudinal axis of the central knife slot 108 of the anvil plate 92.

[0058] The biasing member 118 of the lockout mechanism 114 is positioned within a cavity 122 of the housing 120 and biases the lockout member 116 from an unlocked position spaced apart outside the central knife slot 108 of the anvil assembly 24 toward a locked position. In the locked position, the lockout member 116 extends at least partially across the central knife slot 108 of the anvil assembly 24 to prevent the drive assembly 130 from advancing. In aspects of this disclosure, the biasing member 118 is fixed to a post 129 supported on the anvil assembly 24 within the cavity 122 of the housing 120, so that the biasing member 118 is compressed and positioned between the post 129 and the lockout member 116. In some aspects of this disclosure, the lockout member 116 defines a bore 129a (Figure 8) that receives one end of the biasing member 118. In aspects of this disclosure, the biasing member 118 includes a coil spring, but other types of biasing members are also conceivable.

[0059] Figures 12 and 13 show a drive assembly 130 of a staple fastening device 10 (Figure 1), including an elastic and / or flexible drive beam 132 and an operating member 134. The elastic drive beam 132 has a proximal portion (not shown) that is coupled to a drive rod (not shown) supported within an elongated body 14 of the staple fastening device 10 (Figure 1), and a distal portion that is coupled to the operating member 134. In aspects of this disclosure, the elastic drive beam 132 is formed from a material welded to the operating member 134, for example, a laminated sheet of steel. Alternatively, other constituent materials and fastening techniques are envisioned.

[0060] The working member 134 of the drive assembly 130 has an I-beam configuration and includes a first beam 138, a second beam 140, and a vertical support 142 connecting the first beam 138 to the second beam 140. The vertical support 142 is positioned below the first beam 138 and defines a notch 142a (Figure 13) that receives the second portion 76 (Figure 4) of the knife 66 when the knife 66 moves to its raised position. The working member 134 is positioned proximal to the actuating thread 34a (Figure 12) and is movable between the retracted and advanced positions through the tool assembly 16 (Figure 1) to move the actuating thread and knife assembly 34 from its retracted position to its advanced position through the tool assembly 16 (Figure 1). As the working member 134 moves through the cartridge assembly 26, the first beam 138 is received in a channel 93 (Figure 16) defined within the anvil assembly 24 (Figure 6), the second beam 140 engages with the cartridge assembly 26, and the vertical support 142 moves through the central knife slots 42 (Figure 3) and 108 (Figure 6) of the cartridge body 32 and the anvil plate 92, respectively.

[0061] The vertical support 142 defines the cam channel 152. The cam channel 152 (Figure 13) is angled upward and proximal to the central portion of the vertical support 142 and is positioned to receive the projection 82 (Figure 4) of the knife 66 when the drive assembly 130 moves from its retracted position to its forward position, moving the knife 66 from its lowered position to its raised position.

[0062] Figure 14 shows the drive assembly 130 in the retracted position. When the drive assembly 130 is in its retracted position, the tool assembly 16 is in the open position, the cartridge assembly 26 is pivoted away from the anvil assembly 24, and the working member 134 of the drive assembly 130 is aligned with the anvil assembly 24. The working thread and drive assembly 34 are supported within the cartridge assembly 26 and are not aligned with the drive assembly 130. In the retracted position of the drive assembly 130, the lockout member 116 of the lockout mechanism 114 extends at least partially across the central knife slot 108 (Figure 6) of the anvil assembly 24 and is positioned within the notch 142a of the vertical support 142.

[0063] Figures 15 and 16 show the proximal portion of the tool assembly 16 as the drive assembly 130 is advanced from its retracted position toward the clamped position in the direction of arrow "A". As the working member 134 of the drive assembly 130 advances toward the clamped position, the working member 134 moves and engages with the tool assembly 16, moving the tool assembly 16 from the open position (Figure 1) toward the clamped position. In the clamped position of the drive assembly 130, the vertical support 142 of the working member 134 of the drive assembly 130 is still spaced apart from the central portion of the working thread 34a of the working thread and knife assembly 34, so that the working thread and knife assembly 34 remains in its retracted position. The lockout member 116 of the lockout mechanism 114 also remains in the locked position, extending at least partially into the notch 142a of the vertical support 142 across the central knife slot 108 (Figure 6) of the anvil assembly 24.

[0064] Figures 16 and 17. Figure 16 shows a schematic diagram of the drive assembly 130 and the actuating thread and knife assembly 34 as the drive assembly 130 moves forward from the clamped position, moving the knife 66 from the lowered position (Figure 15) to the raised position (Figure 17). As the drive assembly 130 moves from its clamped position toward its forward position, the projection 82 (Figure 4) on the knife 66 is received within the cam channel 152 (Figure 13) in the vertical support 142 of the drive assembly 130. As the drive assembly 130 continues to move forward, the projection 82 of the knife 66 moves upward through the cam channel 152, pivoting the knife 66 around the pivot member 78 (Figure 4) in the direction of arrow "B" in Figure 17 from the lowered position to the raised position. When the knife 66 is in the raised position, the vertical support 142 of the working member 134 of the drive assembly 130 is positioned in contact with the central portion 52 of the working thread 34a so that further advancement of the drive assembly 130 advances the working thread and knife assembly 34 through the cartridge body 32 (Figure 5) of the staple cartridge 28.

[0065] Figure 18 shows the interaction between the knife 66 and the lockout mechanism 114 as the knife 66 moves from the lowered position to the raised position. As the knife 66 moves from the lowered position to the raised position in the direction of arrow "C" in Figure 18, the second portion 76 of the body 70 of the knife 66 (Figure 17) engages with the distally facing cam surface 126 of the lockout member 116, biasing the lockout member 116 in the direction of arrow "D" relative to the biasing of the biasing member 118, from a locked position that extends at least partially across the central knife slot 108 of the anvil assembly 24 to a further unlocked position within the housing 120 of the lockout mechanism 114. When the lockout member 116 of the lockout mechanism 114 moves to the unlocked position in response to the movement of the knife 66 to the raised position, the drive assembly 130 moves freely from its clamped position to its forward position, advancing the operating thread and knife assembly 34 through the cartridge body 32 (Figure 5), ejecting staples 38 from the staple cartridge 28 (Figure 5), and cutting the tissue clamped between the anvil assembly 24 and the cartridge assembly 26. Note that the lockout member 116 is held in the unlocked position when the drive assembly 130 moves through the cartridge body 32 of the staple cartridge 28 via its engagement with the flexible drive beam 132 of the drive assembly 130.

[0066] Figures 19 and 20 show the drive assembly and anvil assembly 24 as the drive assembly 130 moves from its forward position back to its retracted position. As the drive assembly 130 moves from its forward position back to its retracted position in the direction of arrow "E" in Figure 19, the actuating thread and knife assembly 34 remains in its forward position, and the flexible drive beam 132 engages with the lockout member 116 of the lockout mechanism 114, holding the lockout member 116 in the unlocked position. As the actuating member 134 moves proximally past the lockout member 116 of the lockout mechanism 114, the lockout member 116 moves back to the locked position by the biasing member 118. In the locked position, the lockout member 116 moves back into the notch 142a of the vertical support 142 of the working member 134 of the drive assembly 130, and as a result, the proximal-facing stop surface 127 is positioned at least partially across the central knife slot 108 of the anvil assembly 24, preventing the drive assembly 130 from moving forward again.

[0067] In some aspects of the present disclosure, depending on the configuration of the drive assembly, the distally facing cam surface 126 of the lockout member 116 may be positioned to engage with the vertical support 142 of the drive assembly 130 as the drive assembly moves from an advanced position to its retracted position, moving the lockout member 116 from a locked position to an unlocked position.

[0068] If the staple cartridge 28 does not contain the working thread and knife assembly 34 or the knife 66, the lockout member 116 cannot move from the locked position (Figure 20) to the unlocked position, as described above. Therefore, the stapling device 10 (Figure 1) cannot fire. The disclosed lockout mechanism 114 prevents the stapling device 10 (Figure 1) with a used staple cartridge 28 (Figure 5) from being re-fired, and also prevents the stapling device 10 with a staple cartridge that does not contain a knife from being fired.

[0069] Those skilled in the art will understand that the devices and methods described herein and illustrated in the accompanying drawings are non-limiting and exemplary embodiments. It is anticipated that elements and features illustrated or described in relation to one exemplary embodiment may be combined with elements and features of another embodiment without departing from the scope of this disclosure. Similarly, those skilled in the art will understand the further features and advantages of this disclosure based on the embodiments described above. Therefore, this disclosure is not limited by what is specifically shown and described, except as indicated by the accompanying claims.

Claims

1. A surgical stapling device, wherein the surgical stapling device is A long, slender body having a proximal part and a distal part, A tool assembly supported on the distal portion of the elongated body, the tool assembly includes a cartridge assembly and an anvil assembly coupled to each other to facilitate movement of the tool assembly between an open position and a clamped position, the cartridge assembly includes a staple cartridge, the staple cartridge having a cartridge body defining a central knife slot, staples, a pusher, and an actuating thread and knife assembly, the actuating thread and knife assembly including an actuating thread and a knife defining a cutting edge, the knife being supported on the actuating thread for movement between an up position and a down position, the cutting edge being the central knife of the cartridge body in the up position A tool assembly comprising: an operating thread and knife assembly extending above the slot, wherein in the lowered position the cutting edge is obscured within the central knife slot of the cartridge body, the operating thread and knife assembly being movable within the cartridge body from a retracted position to an advanced position to eject the staple from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly, the anvil assembly including a lockout mechanism, the lockout mechanism being linearly movable from a locked position to an unlocked position, and the operating thread and knife assembly being positioned to bias the lockout mechanism to its unlocked position when the operating thread and knife assembly is in its retracted position; A drive assembly positioned proximal to the actuating thread and knife assembly, wherein the drive assembly is movable relative to the tool assembly between a retracted position and a forward position so as to move the tool assembly between the open position and the clamped position, and move the actuating thread and knife assembly from its retracted position to its forward position. Equipped with, A surgical stapling device, wherein the lockout mechanism is positioned to prevent the drive assembly from moving from its retracted position to its forward position when the lockout mechanism is in its locked position.

2. The surgical stapling device according to claim 1, wherein the lockout mechanism includes a lockout member that is movable between the locked position and the unlocked position.

3. The surgical stapling device according to claim 2, wherein the lockout mechanism includes a biasing member positioned to bias the lockout member to the locked position.

4. The surgical stapling device according to claim 3, wherein the anvil assembly includes an anvil plate supporting a housing that defines an opening, and the lockout member and the biasing member are positioned within the housing.

5. The surgical stapling device according to claim 4, wherein the lockout member is movable through the opening in the housing between the locked position and the unlocked position.

6. The surgical stapling device according to claim 2, wherein the anvil assembly includes an anvil plate defining a central knife slot defining a longitudinal axis, and the lockout member extends over at least a portion of the central knife slot when the lockout member is in the locked position.

7. The surgical stapling device according to claim 6, wherein the drive assembly includes an operating member having an I-beam configuration, the operating member having a first beam, a second beam, and a vertical support connecting the first beam to the second beam, the vertical support being positioned to translate through the central knife slot of the anvil plate as the drive assembly moves between its retracted position and its forward position.

8. The surgical stapling device according to claim 7, wherein the lockout member has a distally facing cam surface defining a plane, the plane defining an acute angle with the longitudinal axis of the central knife slot of the anvil plate, and the distally facing cam surface engages with the vertical support of the drive assembly as the drive assembly is moved from the forward position to its retracted position to move the lockout member from the locked position to the unlocked position.

9. The surgical stapling device according to claim 6, wherein the lockout member includes a proximal-facing stop surface, the proximal-facing stop surface defines a plane perpendicular to the longitudinal axis of the central knife slot of the anvil plate.

10. The surgical stapling device according to claim 9, wherein the knife of the actuating thread and knife assembly is positioned to engage with the lockout member when the actuating thread and knife assembly is in a retracted position to hold the lockout member in the unlocked position.

11. A tool assembly, wherein the tool assembly is A cartridge assembly and anvil assembly coupled to each other to facilitate movement of the tool assembly between an open position and a clamped position, wherein the cartridge assembly includes a staple cartridge, the staple cartridge having a cartridge body defining a central knife slot, a staple, a pusher, and an actuating thread and knife assembly, the actuating thread and knife assembly including an actuating thread and a knife defining a cutting edge, the knife being supported on the actuating thread for movement between an elevated position and a lowered position, in the elevated position the cutting edge extends above the central knife slot of the cartridge body, and in the lowered position the cutting edge is obscured within the central knife slot of the cartridge body, and the actuating thread and knife assembly is movable within the cartridge body from a retracted position to an advanced position to eject the staple from the cartridge body and cut tissue clamped between the cartridge assembly and the anvil assembly, and Equipped with, A tool assembly comprising an anvil assembly including a lockout mechanism, the lockout mechanism being linearly movable from a locked position to an unlocked position, and the actuating thread and knife assembly being positioned to bias the lockout mechanism to its unlocked position when the actuating thread and knife assembly is in its retracted position.

12. The tool assembly according to claim 11, wherein the lockout mechanism includes a lockout member that is movable between the locked position and the unlocked position.

13. The tool assembly according to claim 12, wherein the lockout mechanism includes a biasing member positioned to bias the lockout member to the locked position.

14. The tool assembly according to claim 13, wherein the anvil assembly includes an anvil plate supporting a housing that defines an opening, and the lockout member and the biasing member are positioned within the housing.

15. The tool assembly according to claim 14, wherein the lockout member is movable through the opening in the housing between the locked position and the unlocked position.

16. The tool assembly according to claim 12, wherein the anvil assembly includes an anvil plate defining a central knife slot defining a longitudinal axis, and the lockout member extends over at least a portion of the central knife slot when the lockout member is in the locked position.

17. The tool assembly according to claim 16, wherein the lockout member has a distally facing cam surface that defines a plane, the plane defining an acute angle with the longitudinal axis of the central knife slot of the anvil plate.

18. The tool assembly according to claim 17, wherein the lockout member includes a proximal-facing stop surface, the proximal-facing stop surface defines a plane perpendicular to the longitudinal axis of the central knife slot of the anvil plate.

19. The tool assembly according to claim 18, wherein the knife of the actuating thread and knife assembly is positioned to engage with the lockout member when the actuating thread and knife assembly is in a retracted position in order to hold the lockout member in the unlocked position.

20. A tool assembly, wherein the tool assembly is A cartridge assembly and anvil assembly coupled to each other to facilitate movement of the tool assembly between an open position and a clamped position, wherein the cartridge assembly includes a staple cartridge, the staple cartridge having a cartridge body, staples, a pusher, and an actuating thread and knife assembly, the actuating thread and knife assembly including an actuating thread and a knife, and the actuating thread and knife assembly being movable within the cartridge body from a retracted position to an advanced position to eject the staples from the cartridge body and cut the clamped tissue between the cartridge assembly and the anvil assembly. Equipped with, A tool assembly comprising an anvil assembly including a lockout mechanism, the lockout mechanism being linearly movable from a locked position to an unlocked position, and the actuating thread and knife assembly being positioned to bias the lockout mechanism to its unlocked position when the actuating thread and knife assembly is in its retracted position.

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