# Patent

## Title
Surgical fastener applying apparatus

## Abstract

A surgical fastener applying apparatus for applying fasteners to body tissue. The apparatus includes a cartridge receiving half-section defining an elongated channel member, an anvil half-section, and a clamping lever. The cartridge receiving half-section releasably receives a cartridge and a firing assembly. The clamping lever includes a protrusion in a sidewall which is receivable in a bifurcated depression formed in a sidewall of the cartridge receiving half-section to releasably retain the clamping lever in a non-clamped position and in a clamped position. The apparatus includes a disposable firing assembly and SULU.

## Background
This application claims priority from provisional application Ser. No. 61/494,993, filed Jun. 9, 2011, the entire contents of which are incorporated herein by reference.


BACKGROUND
1. Technical Field
The present disclosure relates to a surgical fastener applying apparatus and, more particularly, to a surgical fastener applying apparatus having reusable and disposable components.
2. Discussion of Related Art
Surgical fastener applying apparatus, wherein tissue is first grasped or clamped between opposing jaw structures and then joined by means of surgical fasteners, are well known in the art. In some such apparatus, a knife is provided to cut the tissue which has been joined by the fasteners. The fasteners are typically in the form of surgical staples, although, other surgical fasteners may also be utilized, such as, for example, clips or two part polymeric surgical fasteners.
Surgical fastener applying apparatus typically include two elongated beam members which are used to capture or clamp tissue therebetween. Typically, one of the beam members carries a disposable cartridge assembly which houses a plurality of staples arranged in at least two lateral rows, while the other beam member includes an anvil which defines a surface for forming the staple legs as the staples are driven from the cartridge assembly. Where two part fasteners are used, the beam member which includes the anvil carries a mating part of the two part fastener, e.g. the receiver. Generally, the staple formation process is affected by the interaction between one or more longitudinally moving camming members and a series of individual staple pushers. As the camming members travel longitudinally through the cartridge carrying beam member, the individual pusher members are biased upwardly into a backspan of the staples supported within the cartridge assembly to sequentially eject the staples from the cartridge. A knife may be provided to travel with the camming members between the staple rows to cut the tissue between the rows of formed staples. An example of such an instrument is disclosed in U.S. Pat. No. 7,631,794, which is incorporated herein in its entirety by reference.
Because of the dangers associated with improper sterilization, surgical fastener applying apparatus are typically disposable after use. Although the cartridge assembly may be replaced to perform multiple fastener applying operations on a single patient, the staple applying apparatus is typically disposable after a surgical procedure has been completed on the patient. This requirement of disposability may increase the costs associated with surgical procedures. Although reusable fastener applying apparatus have been developed, such apparatus can be overly complex and prove difficult to sterilize.
A need exists in the art for a fastener applying apparatus which includes reusable components, is not overly complex and is configured to facilitate proper sterilization after use in a surgical procedure.
SUMMARY
The present disclosure relates to a surgical fastener applying apparatus comprising an anvil half-section including a distal anvil portion and a proximal handle portion and a cartridge receiving half-section defining an elongated channel member. The elongated channel member has a distal portion dimensioned to releasably receive a cartridge and a proximal portion configured to support a firing assembly. The cartridge receiving half-section further includes a sidewall defining a bifurcated depression having a first depression portion and a second depression portion separated by a raised depression divider. A clamping lever is secured to the cartridge receiving half-section and has a proximal portion including a handle portion and a distal portion. The clamping lever is operably associated with the anvil half-section and the cartridge receiving half-section and is movable from an unclamped position to a clamped position to releasably secure the anvil portion of the anvil half-section in close approximation with the cartridge. The clamping lever further includes a sidewall having a protrusion which is positionable within the first depression portion of the bifurcated depression to releasably retain the clamping lever in the unclamped position and is positionable within the second depression portion of the bifurcated depression to releasably retain the clamping lever in the clamped position.
In one embodiment the clamping lever is releasably secured to the cartridge receiving half-section.
The apparatus can also include a firing assembly which is configured to be releasably secured within the proximal portion of the cartridge receiving half-section and includes a firing lever and a cam bar fixedly secured to the firing lever. The firing assembly may also include a stationary housing, which is configured to be releasably supported in the proximal portion of the cartridge receiving portion.
In one embodiment, the stationary housing includes a U-shaped frame including a bottom wall and a pair of sidewalls, wherein each of the sidewalls has a proximal end having a firing assembly protrusion which is positioned to be releasably received in a recess formed in the proximal end of the elongated channel member to releasably retain the stationary housing within the proximal portion of the elongated channel member. The firing assembly may also include a knife actuating bar which is configured to engage a knife supported within the single use loading unit.
In one embodiment, the protrusion includes a flat sidewall which abuts the raised depression divider when the clamping lever is in the clamped position. The protrusion can be deformable and can pass over the raised depression divider when the clamp lever is moved between the unclamped position and the clamped position. The clamping lever may be pivotally secured to the cartridge receiving half-section wherein the clamping lever is pivotal to move the protrusion from the first depression portion of the bifurcated depression over the raised depression divider into the second depression portion of the bifurcated depression.
In one embodiment, the cartridge receiving half-section includes a pair of pivot members, each pivot member having a flat surface. In one embodiment, the flat surface is positioned at a proximal surface of the pivot member.
In one embodiment, the clamping lever includes a pair of C-shaped recesses having a width smaller than a diameter of the pivot member such that the pivot members need to be slid into the C-shaped recesses along the flat surfaces to attach the clamping lever to the cartridge receiving half-section. In one embodiment, the clamping lever is at a first angle with respect to the cartridge receiving half-section to attach the clamping lever to the cartridge receiving half-section and is at a second smaller angle with respect to the cartridge receiving half-section in the unclamped position.
In one embodiment, the cartridge receiving half-section has a pair of U-shaped recesses to receive lateral support members of the anvil half-section. The U-shaped recesses and pivot members of the cartridge receiving half-section can be distal of the bifurcated depression.



BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments of the presently disclosed surgical fastener applying apparatus will now be described herein with reference to the accompanying figures wherein:
FIG. 1 is a side perspective view from the distal end of one embodiment of the presently disclosed surgical fastener applying apparatus in the clamped position;
FIG. 1A is a side perspective view from the proximal end of the surgical fastener applying apparatus shown in FIG. 1 in the clamped position;
FIG. 2 is a side perspective view of the surgical fastener applying apparatus shown in FIG. 1 in the open position;
FIG. 2A is a side view of a portion of the cartridge receiving half-section and the clamping lever during assembly of the clamping lever and the cartridge receiving half-section;
FIG. 2B is a side perspective view of the fastener applying apparatus shown in FIG. 1 in the closed, unclamped position;
FIG. 2C is an enlarged view of the indicated area of detail shown in FIG. 2;
FIG. 2D is a cross-sectional view taken along section lines 2D-2D of FIG. 1A;
FIG. 3 is a side perspective view of the surgical fastener applying apparatus shown in FIG. 1 with parts separated;
FIG. 3A is a bottom, side cross-sectional view of the clamping lever of the surgical fastener applying apparatus shown in FIG. 1;
FIG. 4 is a side perspective view of the cartridge receiving half-section of the surgical fastener applying apparatus with the single use loading unit (“SULU”) and the firing assembly supported within the cartridge receiving half-section;
FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 4;
FIG. 6 is a perspective view from above of the cartridge receiving half-section of the surgical fastener applying apparatus with the SULU and the firing assembly supported therein;
FIG. 7 is an enlarged view of the indicated area of detail shown in FIG. 6;
FIG. 8 is a front end perspective view from above of the firing assembly of the surgical fastener applying apparatus shown in FIG. 3;
FIG. 9 is an enlarged view of the indicated area of detail shown in FIG. 8;
FIG. 9A is a top perspective view of the channel member with the firing assembly releasably secured therein;
FIG. 9B is an enlarged view of the indicated area of detail shown in FIG. 9A;
FIG. 9C is a top perspective view of a central portion of the channel member;
FIG. 10 is a rear end perspective view from above of the firing assembly shown in FIG. 8;
FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. 10;
FIG. 12 is a side perspective view of the firing assembly shown in FIG. 10 with parts separated;
FIG. 12A is a perspective view from below of the cam bar of the firing assembly shown in FIG. 12;
FIG. 12B is a perspective view from below of the firing lever of the firing assembly shown in FIG. 12;
FIG. 13 is a side perspective view of the SULU of the surgical fastener applying apparatus shown in FIG. 1;
FIG. 14 is an enlarged view of the indicated area of detail shown in FIG. 13;
FIG. 15 is a front perspective view of the SULU shown in FIG. 13;
FIG. 16 is an enlarged view of the indicated area of detail shown in FIG. 15;
FIG. 17 is a side perspective view with parts separated of the SULU shown in FIG. 15;
FIG. 18 is a side cross-sectional view of the surgical fastener applying apparatus shown in FIG. 1 in the open position;
FIG. 19 is an enlarged view of the indicated area of detail shown in FIG. 18;
FIG. 20 is an enlarged view of the indicated area of detail shown in FIG. 18;
FIG. 21 is a perspective view of the proximal end of the surgical fastener applying apparatus shown in FIG. 18 in the open position;
FIG. 22 is a side view of the cartridge receiving half-section and clamp lever of the surgical fastener applying apparatus shown in FIG. 1 with the clamp lever in the unclamped position;
FIG. 23 is an enlarged view of the indicated area of detail shown in FIG. 22;
FIG. 24 is a side perspective view of the surgical fastener applying apparatus shown in FIG. 1 in the clamped position;
FIG. 25 is a side cross-sectional view of the surgical fastener applying apparatus shown in FIG. 24 in the clamped position;
FIG. 26 is an enlarged view of the indicated area of detail shown in FIG. 25;
FIG. 27 is a side view of the cartridge receiving half-section and clamp lever of the surgical fastener applying apparatus shown in FIG. 1 with the clamp lever in the clamped position;
FIG. 27A is an enlarged view of the indicated area of detail shown in FIG. 27;
FIG. 28 is a cross-sectional view taken along section lines 28-28 of FIG. 26;
FIG. 29 is a top view of the surgical fastener applying apparatus shown in FIG. 1 as the firing assembly is moved through an actuating stroke to eject fasteners from the apparatus;
FIG. 30 is a side cross-sectional view of the surgical fastener applying apparatus shown in FIG. 29 with the firing assembly in the actuated position;
FIG. 31 is an enlarged view of the indicated area of detail shown in FIG. 30;
FIG. 32 is an enlarged view of the indicated are of detail shown in FIG. 30;
FIG. 33 is a side cross-sectional view of the surgical fastener applying apparatus shown in FIG. 1 after the apparatus has been fired and moved to the open position; and
FIG. 34 is an enlarged view of the indicated area of detail shown in FIG. 33.



DETAILED DESCRIPTION OF EMBODIMENTS
Embodiments of the presently disclosed surgical fastener applying apparatus in accordance with the present disclosure will now be described in detail with reference to the drawings wherein like reference numerals identify similar or identical structural elements. As used herein, as is traditional, the term “proximal” refers to the end of the apparatus which is closer to the user and the term distal refers to the end of the apparatus which is further away from the user.
FIGS. 1-34 illustrate an illustrative embodiment of the presently disclosed surgical fastener applying apparatus designated generally as surgical stapler 10. Referring specifically to FIGS. 1-3, surgical stapler 10 includes an anvil half-section 12, a cartridge receiving half-section 14, a clamping lever 16, a single use loading unit or cartridge 18 (hereinafter “SULU”) and a firing assembly 20. In one embodiment, anvil half-section 12, cartridge receiving half-section 14 and clamping lever 16 are constructed to be reusable components and, as such, are constructed from a biocompatible material suitable for sterilization and repeated use, e.g., stainless steel. In contrast, SULU 18 and firing assembly 20 are constructed to be disposable and, as such, may be constructed from any suitable biocompatible material, e.g., plastics, metals, combinations thereof, having the requisite strength characteristics. SULU 18 and firing assembly 20 can alternatively be constructed as an integral unit to be loaded as a single unit into the cartridge receiving half-section 18.
Referring to FIGS. 3-7, cartridge receiving half-section 14 defines an elongated channel member 22 which defines a substantially U-shaped channel 24 having a distal portion 24a dimensioned to releasably receive a SULU 18 and a proximal portion 24b dimensioned to releasably receive firing assembly 20. Firing assembly 20 includes a stationary housing 26 (see also FIG. 12) having a proximal end including flexible protrusions 28 which extend into recesses 30 formed in a proximal portion of cartridge receiving half-section 14 to releasably secure the proximal end of firing assembly 20 within the proximal portion 24b of channel member 22. The distal end of firing assembly 20 defines an extension 64d which is positioned to engage a protrusion 65 formed on an inner wall of channel member 22 (see FIGS. 9A-9C) to releasably secure the distal end of firing assembly 20 within channel member 22. Protrusion 65 is positioned on top of extension 64d as shown in FIG. 9B. The structure of firing assembly 20 will be discussed in further detail below. SULU 18 includes a pair of distal protrusions 32 (FIG. 3) which are positioned in cutouts 34 formed at the distal end of channel member 22 to releasably secure SULU 18 within the distal portion 24a of channel member 22. During assembly, firing assembly 20 must be inserted into proximal portion 24b of channel member 22 before SULU 18 is inserted into distal portion 24a of channel member 22 as will be discussed below. To position SULU 18 in channel member 22, protrusions 32 on SULU 18 are positioned within cutouts 34 while SULU 18 is positioned above and at an angle to channel member 22. Thereafter, SULU 18 can be rotated downwardly into distal portion 24a of U-shaped channel 24. This allows for the drive components of firing assembly 20 to properly align with components of SULU 18 and also facilitates engagement of the firing assembly 20 with a knife 40 (FIG. 17) supported within SULU 18. A proximal end of SULU 18 includes an outwardly extending serrated surface 42 (FIG. 7) to facilitate gripping of the proximal end of SULU 18 for removal and/or replacement of SULU 18 from channel member 22. Prior to movement of stapler 10 to the clamped position, as will be discussed below, serrated gripping surface 42 will not fully seat within distal portion 24a of channel member 22.
Referring to FIGS. 8-12, firing assembly 20 includes stationary housing 26, a knife actuating bar 44, a cam bar 46, a guide block 48, a firing lever 50, a slide block 52 and a pedal 54. In one embodiment, stationary housing 26 includes a U-shaped frame 60 including a bottom wall 62 and a pair of sidewalls 64. A proximal end of each sidewall 64 supports a respective flexible protrusion 28. Protrusions 28 are able to flex inwardly into recesses 30 of channel member 22 (FIG. 21) to releasably secure firing assembly 20 within proximal portion 24b (FIG. 3) of channel member 22 as discussed above. The distal end of each sidewall 64 defines a proximal step 64b, an angled portion 64c and a distal angled portion (extension) 64d. As discussed above, extension 64d is positioned to engage protrusion 65 (FIG. 9B) formed on an inner wall of channel member 22 to retain the distal end of firing assembly 20 within channel member 22. Each sidewall 64 includes an overhang 66 for slidably retaining slide block 52 within stationary housing 26.
Guide block 48 includes a body defining three longitudinal slots 70a-c and a pair of outwardly extending protrusions 72. In one embodiment, each protrusion 72 is substantially cylindrical and includes a tapered portion 72a (FIG. 9). Alternately, other protrusion configurations are envisioned. Protrusions 72 are dimensioned to be received in openings 74 (FIG. 12) formed in sidewalls 64 of stationary housing 26 to axially fix guide block 48 within the distal end of stationary housing 26. Protrusions 72 allow for a degree of pivotal movement of guide block 48 within U-shaped frame 60. As will be discussed in further detail below, guide block 48 is pivotal from a first position (FIG. 19) in locking engagement with notches 49 and 51 of knife actuating bar 44 to a second position (FIG. 26) disengaged from notches 49 and 51 of knife actuating bar 44 in response to movement of stapler 10 to the clamped position. A torsion spring (not shown) is provided about protrusions 72 to urge the guide block 48 towards the first position. Each of slots 70a and 70c is dimensioned to slidably receive a respective sidewall 114 of cam bar 46. Similarly, slot 70b is dimensioned to slidably receive knife actuating bar 44.
Slide block 52 includes a hub 80 which includes a resilient finger 80a configured to be snap-fit into a pivot hole 82 formed in firing lever 50. Firing lever 50 is pivotal about hub 80 when the slide block 52 is in a retracted position to facilitate actuation of the firing assembly 20 from either side of stapler 10. Pedal 54 is reciprocally received within a hole 84 formed in slide block 52. Pedal 54 includes a split body portion 54a which is configured to straddle a proximal end 102 of knife actuating bar 44. In one embodiment, split body portion 54a includes an angled distal surface 86. A pin 88 extends upwardly from pedal 54 through hole 84 in slide block 52. A biasing member 90 is positioned between split body portion 54a and slide block 52, about pin 88 to urge pedal 54 downwardly away from slide block 52. In the retracted position of slide block 52, pedal 54 is received in a cutout 55 formed in a bottom wall 22a of channel member 22 (FIG. 20).
Firing lever 50 includes first and second finger engagement members 50a and 50b, either one of which can be selectively engaged to move the firing lever 50 through a firing stroke from either side of stapler 10. An arcuate recess 94 (FIG. 12B) is formed in a bottom surface of firing lever 50 which slidably receives pin 88 of pedal 54 to define the range of rotation through which firing lever 50 can pivot about hub 80 of slide block 52. As used herein, a firing stroke is defined as movement of firing lever 50 from a fully retracted position (FIG. 25) to a fully advanced position (FIG. 30). A stop recess 94a is formed at each end of arcuate recess 94. Stop recesses 94a are configured and dimensioned to receive the end of pin 88 of pedal 54 to prevent pivotal movement of firing lever 50 about hub 80 during a firing stroke of surgical stapler 10. More specifically, when the firing assembly 20 is actuated to advance slide block 52 distally within stationary housing 26, angled distal surface 86 of pedal 54 engages channel member 22 and is cammed out of cutout 55 (FIG. 20) to urge pin 88 upwardly into a stop recess 94a to prevent pivotal movement of firing lever 50 during movement of firing lever 50 through a firing stroke. As is evident, pin 88 must be positioned beneath a stop recess 94a to allow pedal 54 to lift upwardly from cutout 55 to allow firing lever 50 to be moved through the firing stroke. Thus, firing lever 50 must be pivoted to one side or the other of firing assembly 20 before the firing lever 50 can be moved through a firing stroke.
Knife actuating bar 44 includes a proximal end having a stepped portion 100 which includes a proximal first step 102 having a first height and a second step 104 having a second height which is greater than the first height. A distal end of actuating bar 44 includes an upturned hook portion 106 and upper and lower notches 49 and 51. A finger 108 projects upwardly from knife actuating bar 44 between first and second steps 102 and 104. As shown in FIG. 20, finger 108 is slidably received within a recess 110 formed in an underside of slide block 52. When slide block 52 is advanced distally within stationary housing 26, finger 108 moves within recess 110 such that slide block 52 moves in relation to knife actuating bar 44 until finger 108 engages a wall 112 (FIG. 32) defining a proximal end of recess 110. When finger 108 engages wall 112, further distal movement of slide block 52 will also effect distal movement of knife actuating bar 44. As will be evident below, this arrangement allows for staples to be ejected from SULU 18 prior to cutting of tissue.
Referring to FIGS. 12 and 12A, cam bar 46 includes a pair of sidewalls 114 and a base wall 116. The proximal end 114a of each sidewall 114 includes a raised wall portion 118. Each raised wall portion 118 is configured to be fixedly received in a slot (not shown) formed in an underside of slide block 52 to fixedly secure the proximal end of cam bar 46 to slide block 52. Alternately, slide block 52 may be molded about the proximal end of knife actuating bar 44. The distal end of each sidewall 114 includes an angled camming surface 114b. Base wall 116 defines a distally extending elongated slot 123 (FIG. 12A) which extends from the distal end of cam bar 46 along a substantial length of the cam bar 46 and a proximally extending longitudinal slot 121. Slot 121 is positioned to facilitate the passage of pedal 54 through cutout 55 of channel member 22 when slide block 52 is in the retracted position (see FIG. 20).
Sidewalls 114 of cam bar 46 are slidably positioned in slots 70a and 70c of guide block 48 and knife actuating bar 44 is slidably positioned in longitudinal slot 70b of guide block 48. When firing assembly 20 is supported in channel member 22 and firing lever 50 is pivoted to one side of stationary housing 26 and pushed distally, slide block 52 is moved distally within stationary housing 26. As slide block 52 begins to move distally, tapered surface 86 of pedal 54 engages a distal edge of channel member 22 defining cutout 55 to urge pedal 54 upwardly out of cutout 55, through slot 121 of cam bar 46, and onto an inner surface of stationary housing 26 of firing assembly 20 (FIG. 20). As this occurs, pin 88 of pedal 54 moves into a stop recess 94a to prevent further pivotal movement of firing lever 50. If firing lever 50 is not pivoted to a position in which pin 88 is positioned beneath a stop recess 94a, pedal 54 will be prevented from moving upwardly out of cutout 55 and firing lever 50 will be prevented from moving through a firing stroke. As firing lever 50 is moved distally, finger 108 moves within recess 110 such that knife actuating bar 44 remains stationary as cam bar 46 is advanced distally. When finger 108 engages proximal wall 112 defining recess 110, knife actuating bar 44 is moved distally with slide block 52 and cam bar 46. As will be discussed below, when cam bar 46 and knife actuating bar 44 are moved distally within stationary housing 26 of firing assembly 20 and channel member 22, angled camming surfaces 114b of cam bar 46 are moved through SULU 18 to eject fasteners from SULU 18. Simultaneously, although with a preset delay equal to the length of recess 110 (FIG. 20), knife actuating bar 44 drives a knife blade 40 through SULU 18 to dissect tissue.
U.S. Pat. No. 7,631,794 (“the '794 patent”) discloses a surgical fastener applying apparatus which includes a firing assembly similar to that described above. The '794 patent is incorporated herein by reference in its entirety.
FIGS. 13-17 illustrate SULU 18. SULU 18 includes a body 120, a plurality of staple pushers 122 (only one is shown), a bottom cover 124, a knife 40 having an angled sharpened leading edge or blade 40a, a plurality of staples 126 (only one is shown), and a pivotally mounted safety lockout 128. A proximal end of body 120 includes a flexible finger 120a which projects slightly beyond the outer wall defining body 120. Finger 120a frictionally engages an inner wall of channel member 22 (FIG. 14) to retain the proximal end of SULU 18 within channel member 22 when SULU 18 is releasably positioned within channel member 22. As is known in the art, body 120 has a plurality of rows of staple retaining slots 130, e.g., four, six, etc. and a linear slotted knife track 132 centrally disposed in body 120. Surgical stapler 10 can be dimensioned to receive or accommodate SULU's of different staple line lengths including, e.g., 60 mm, 80 mm and 100 mm. Knife 40 includes a downturned hook portion 40b which is positioned to engage upturned hook portion 106 (FIG. 12) of knife actuating bar 44 when SULU 18 is positioned within channel member 22.
In the illustrated embodiment, body 120 includes two staggered rows of slots 130 formed on either side of linear slotted knife track 132. The staggered rows of slots 130 extend beyond the distal end of knife track 132 to facilitate staple formation beyond the distal end of the stroke of the knife blade 40.
Staple pushers 122 may be configured to extend into one or more slots 130. In one embodiment, a single pusher is associated with each slot 130. Alternately, as illustrated in FIG. 17, each pusher 122 can be configured to extend into two adjacent slots 130 and is positioned beneath respective staples 126 which are retained in slots 130. As is known in the art, each pusher 122 includes a lower cam surface 122a which is positioned to engage one of cam surfaces 114b (FIG. 12) on the distal end of cam bar 46 such that movement of cam bar 46 through SULU 18 sequentially lifts each respective pusher 122 within its respective slot or slots 130 to eject staples from slots 130.
Bottom cover 124 partially encloses a channel 125 (FIG. 18) formed within the cartridge body 120. A longitudinal ridge 134 (FIG. 17) is formed on an upper surface of bottom cover 124 and provides a bearing surface for a knife supporting member 136 which is secured to a bottom edge of knife 40. Knife 40 may be secured to supporting member 136 via pins, welding or other known fastening techniques. During a firing stroke, knife 40 is guided along knife track 132 as the firing lever 50 is advanced through channel member 22. A pair of slots 138 are defined between the sides of ridge 134 and an outer wall of cartridge body 120. Longitudinal ridge 134 is positioned within body 120 and dimensioned to be slidably received in elongated slot 123 (FIG. 12a) of cam bar 46 such that cam bar 46 is slidably movable through cartridge body 120 about longitudinal ridge 134 to eject staples 126 from SULU 18.
Safety lockout 128 is pivotally disposed on an upper proximal end of body 120 and is pivotal about a pivot member 150 from a locked orientation (FIG. 26) to unlocked orientation (FIG. 34). Pivot member 150 is received in openings 154 in body 120. A biasing member, e.g., spring 152, is positioned between knife supporting member 136 and safety lockout 128 to urge safety lockout 128 towards the unlocked orientation. Safety lockout 128 includes a proximal hook 156 which is positioned to receive an engagement member 158 formed on the knife 40 to retain the safety lockout 128 in the locked orientation when the knife 40 is in the retracted position (FIG. 19). When the knife 40 is moved towards the advanced position during a firing stroke, engagement member 158 is moved away from proximal hook 156 to allow safety lockout 128 to pivot towards the unlocked position in response to the urging of spring 152. It is noted that safety lockout 128 is prevented from pivoting to the unlocked position when the anvil half-section 12 and cartridge receiving half-section 14 are in the clamped position because the top surface 128a of safety lockout 128 engages an inner surface of anvil half-section 12 to prevent pivoting of safety lockout 128. Safety lockout 128 defines a slot 160 (FIG. 16) dimensioned to slidably receive the knife 40. In the retracted position of the knife 40, the leading edge 40a of knife 40 is confined within slot 160 of safety lockout 128 to prevent accidental engagement and injury to medical personnel with leading edge 40a of knife 40.
Referring again to FIGS. 2-3, anvil half-section 12 includes a proximal handle portion 12a and a distal anvil portion 12b. Anvil portion 12b includes a staple deforming portion 198 which, as known in the art, includes a plurality of staple deforming recesses and faces a top surface of SULU 18 when SULU 18 is positioned in the channel member 22. As is also known in the art, the staple deforming portion 198 includes a central longitudinal slot (not shown) for receiving the knife 40 (FIG. 17) as the knife 40 is moved through the SULU 18. The staple deforming portion 198 can be formed integrally with anvil half-section 12, or in the alternative, secured to anvil half-section 12 by a fastening process such as welding. A pair of locating fingers 170 are positioned adjacent the proximal end of the staple deforming portion 198 of anvil portion 12b and engage grooves in SULU 18 to properly align SULU 18 with staple deforming portion 198.
A central portion of anvil half-section 12 includes a pair of cylindrical lateral support members 172. During assembly of anvil half-section 12 and cartridge receiving half-section 14, lateral support members 172 are supported in U-shaped recesses 174 formed on a central portion 173 of cartridge receiving half-section 14 (FIG. 28). Lateral support members 172 are also positioned to be received in cutouts 176 formed on spaced flange portions 178 of clamping lever 16 when the clamping lever 16 is moved to the clamped position (FIG. 1). Proximal handle portion 12a is ergonomically formed and includes a thumb-engaging abutment 180 and a gripping portion 182. A proximal end of handle portion 12a includes a downwardly extending finger 184 (FIG. 21) which includes a pair of opposed teardrop shaped protrusions 186 which will be discussed in further detail below. Alternately, protrusions 186 may assume a variety of configurations.
Referring back to FIG. 3, cartridge receiving half-section 14 includes a central portion 173 which defines spaced centrally disposed U-shaped recesses 174 positioned to support lateral support members 172 of anvil half-section 12. A distal wall 173a of central portion 173 defines tissue stops. A pair of lateral cylindrical pivot members 187 are positioned beneath recesses 174. Each pivot member defines a flat 187a (see also FIG. 2A). The proximal end of cartridge receiving half-section 14 also includes a pair of vertical support members 188. Each vertical support member 188 includes an elongated vertical slot 188a having a rounded bottom surface. Vertical slots 188a are dimensioned to receive protrusions 186 formed on finger 184 of anvil half-section 12 (FIG. 21) when the anvil half-section 12 is supported on the cartridge receiving half-section 14 during assembly. By positioning protrusions 186 within vertical slots 188a, anvil half-section 12 can be pivoted in a scissor-like action with respect to the cartridge receiving half-section 14 between open and closed positions. In one embodiment, protrusions 186 have a teardrop profile. At least one sidewall of cartridge receiving half-section 14 includes a bifurcated depression 189 (see FIG. 3) which will be discussed in further detail below.
Clamping lever 16 includes a handle portion 190 including a grip 190a and a thumb engaging abutment 192. As discussed above, a pair of spaced flange portions 178 are supported on the distal end of clamping lever 16. Each flange portion 178 defines a cutout 176 dimensioned to receive a respective lateral support member 172 of anvil half-section 12 when stapler 10 is moved towards clamped position (FIG. 2B). The distal end of clamping lever 16 also defines a pair of distal C-shaped recesses 194 which are dimensioned to receive pivot members 187 of cartridge receiving half-section 14. Each recess 194 defines a mouth which is smaller in width than the diameter of the pivot members 187. Because the mouth of each C-shaped recess 194 is smaller in width than the diameter of the pivot member 187, when clamp lever 16 is secured to cartridge receiving half-section 14 (FIG. 24), the pivot members 187 must be slid into recesses 194 in the direction indicated by arrow “x” in FIG. 2A along the surface of flats 187a of the pivot members 187. As such, clamping lever 16 must be positioned at an acute angle to cartridge receiving half-section 14 as shown in FIG. 2A to pivotally secure clamping lever 16 about pivot members 187 of cartridge receiving half-section 14. As shown, this angle is at a greater angle with respect to the cartridge receiving half-section than the angle of the clamping lever with respect to the cartridge receiving half-section in the unclamped position. After positioning pivot members 187 in C-shaped recesses 194, clamping lever 16 can be rotated in a counter-clockwise direction as shown in FIG. 2A to the position shown in FIG. 2 to secure clamp lever 16 to cartridge receiving half-section 14.
As shown in FIG. 3A, an inner wall of flange portion 178 of clamping lever 16 includes a circular protrusion 201 having a flat side wall 201a. As clamping lever 16 is rotated from the position shown in FIG. 2A to the position shown in FIG. 2B, protrusion 201 moves along and is deformed by an outer wall of cartridge receiving half-section 14 until protrusion 201 moves into a first portion 189a of bifurcated depression 189 (FIG. 2A) formed in the sidewall of cartridge receiving half-section 14. Bifurcated depression 189 is formed proximal of U-shaped recesses 174 and proximal of the lateral support members 172 of the cartridge receiving half-section 14. By positioning protrusion 201 in first portion 189a of depression 189, clamping lever 16 is prevented from rotating to a position in which the clamping lever 16 can be disengaged with the cartridge receiving half-section 14 (FIG. 2A) and is, thus, retained in the open position or unclamped position (FIG. 22). Upon movement of clamp lever 16 to the clamped position, protrusion 201, which is deformable, passes over a raised depression divider 189c (FIG. 5) into a second portion 189b of bifurcated depression 189b to retain clamp lever 16 in the clamped position (FIG. 27A). In this position, flat side wall 201a of protrusion 201 abuts depression divider 189c. Note that the first and second depression portions 189a, 189b are of different configurations, but alternatively could be of similar configurations. Also note the depression portions 189a, 189b can have a height or space exceeding the diameter of the protrusion 201 to provide room for the protrusion to move within portions 189a, 189b. 
Referring to FIGS. 2 and 2C, after clamping lever 16 has been secured to cartridge receiving half-section 14 and SULU 18 and firing assembly 20 are loaded into channel member 22, anvil section 12 can be assembled to cartridge receiving half-section 14. It is noted that SULU 18 and firing assembly 20 can be loaded into channel member 22 prior to or after securement of clamping lever 16 to cartridge receiving half-section 14. To attach anvil half-section 12 to cartridge receiving half-section 14, protrusions 186 of finger 184 are positioned in vertical slots 188a of vertical support member 188 of cartridge receiving half-section 14. Thereafter, anvil half-section 12 is rotated towards cartridge receiving half-section 14 to position lateral supports members 172 in U-shaped recesses 174.
In order to position surgical stapler 10 in the clamped position, clamping lever 16 is rotated in a counter-clockwise direction from the position shown in FIG. 2B. As clamping lever 16 is rotated, lateral support members 172 are received in cutouts 176 of flange portions 178 and cammed towards cartridge receiving half-section 14. In the clamped position shown in FIG. 1, the staple deforming portion 198 is positioned in close approximation with the top surface of SULU 18.
Referring to FIGS. 3, 12, 19 and 26, as discussed above, guide block 48 is pivotally supported in stationary housing 26 of firing assembly 20. Guide block 48 includes a distally extending nose portion 220 (FIG. 12) which rests beneath SULU 18 when SULU 18 is supported in channel member 22. The internal surface of guide block 48 includes locking surfaces 222 (FIG. 19) which are received in notches 49 and 51 of knife actuating bar 44 when the stapler 10 is in an unclamped position. When the SULU 18 is positioned in the channel member 22, prior to moving clamp lever 16 to the clamped position, SULU 18 is positioned atop nose portion 220 and is not fully seated in the channel member 22, as discussed above. When the stapler 10 is moved to the clamped position, locating fingers 170 (FIG. 3) of anvil half-section engage a top surface of body 120 of SULU 18 to fully seat SULU 18 in channel member 22. Thereafter, locating fingers 170 engage grooves SULU 18 to properly position SULU 18 in relation to anvil portion 12b. As SULU 18 is fully seated in channel member 22, SULU 18 presses downwardly on nose portion 220 of guide block 48 to pivot guide block 48 about protrusions 72. When guide block 48 pivots, locking surfaces 222 move from notches 49 and 51 to unlock knife actuating bar 44 (FIG. 26). This configuration prevents movement of the knife actuating bar 44 in relation to guide block 48 prior to clamping to ensure that the knife actuating bar 44 and SULU knife 40 remain properly positioned for operational engagement prior to use.
Referring to FIGS. 24-28, when stapler 10 is in the clamped, unfired position, slide block 52 of firing assembly 20 is in the retracted position at the proximal end of channel member 22 and stationary housing 26 (see FIG. 25). In this position, pedal 54 is positioned in cutout 55 of channel member 22 and pin 88 of pedal 54 is positioned in arcuate recess 94 of firing lever 50 beneath stop recesses 94a (FIG. 12B). As such, firing lever 50 can be pivoted to facilitate actuation of stapler 10 from either side of the stapler 10. In addition, in this position of slide block 52, finger 108 of knife actuating bar 44 is positioned adjacent the distal wall of recess 110 of slide block 52. Protrusion 201 is positioned in second portion 189b of bifurcated depression 189 to retain clamping lever 16 in the clamped position. As discussed above, flat sidewall 201a of protrusion 201 is positioned to abut depression divider 189c to prevent inadvertent removal of protrusion 201 from second portion 189b (FIG. 27A).
Referring to FIGS. 25 and 26, when slide block 52 is in the retracted position, knife 40 and cam surfaces 114b (FIG. 9) of cam bar 46 are positioned in the proximal end of SULU 18 and, proximal hook 156 of safety lockout 128 is positioned in engagement with engagement member 158 of knife 40 to retain safety lockout 128 in the locked orientation. In addition, downturned hook portion 40b of knife 40 is engaged with upturned hook portion 106 of knife actuating bar 44 to connect firing assembly 20 to knife 40 of SULU 18.
Referring to FIGS. 29-32, when the firing lever 50 is advanced distally in the direction indicated by arrow “A” in FIG. 29, slide block 52 (FIG. 32) is moved distally within stationary housing 26 of firing assembly 20 to effect corresponding movement of cam bar 46 and delayed movement of knife actuating bar 44. As discussed above, the delayed movement of the knife actuating bar 44 is equal to the length of recess 110 of slide block 52 and results from movement of finger 108 of knife actuating bar 44 within recess 110 of slide block 52. Movement of knife actuating bar 44 with slide block 52 begins when finger 108 abuts the proximal wall 112 of recess 110. As cam bar 46 is moved distally through stationary housing 26 of firing assembly 20, cam surfaces 114b on sidewalls 114 of cam bar 46 are advanced through SULU 18 to sequentially engage pushers 122 (FIG. 17) to eject staples 126 from slots 130 of body 120. Concurrently, since the distal end of knife actuating bar 44 is engaged with knife 40, knife 40, after the preset delay, is advanced through SULU 18 to incise tissue between the staple lines.
As shown in phantom in FIG. 32, when slide block 52 moves distally within stationary housing 26, pedal 54 rides up over channel member 22 and moves along inner surface of stationary housing 26 of firing assembly 20. When this occurs, pin 88 of pedal 54 moves into a stop recess 94a to prevent further pivotal movement of firing lever 50.
Referring to FIG. 32, when knife 40 is moved distally within SULU 18, engagement member 158 of knife 40 is disengaged with proximal hook 156 of safety lockout 128.
Referring to FIGS. 33 and 34, when the firing lever 50 is returned to its proximal-most position to retract cam bar 46 and knife 40, clamping lever 16 is manually pivoted to disengage protrusion 201 from second portion 189b of bifurcated depression 189 to move clamp lever 16 to its unclamped position to allow stapler 10 to move to the open position. In the open position, anvil half-section 12 is spaced from cartridge receiving half-section 14 and spring 152 (FIG. 17) pivots safety lockout 128 in the direction indicated by arrow B in FIG. 34 about pivot member 150 to its unlocked position such that safety lockout 128 projects upwardly from SULU 18. In the unlocked position, safety lockout 128 prevents movement of the stapler 10 back to the clamped position. In order to reuse stapler 10, used SULU 18 must be replaced with a new SULU 18.
During a surgical procedure, SULU 18 can be replaced multiple times to facilitate multiple uses of stapler 10 on a single patient. If an integrated unit is provided, the SULU and firing assembly can be replaced multiple times. Since each SULU 18 is provided with a fresh knife 40, tearing of tissue is minimized. After the surgical procedure, the used SULU(S) 18 and the firing assembly 20 can be removed from the channel member 22 and disposed of in an appropriate manner. Thereafter, clamping lever 16 can be removed from cartridge receiving half-section 14 by rotating clamping lever 16 to the position shown in FIG. 2A and disengaging pivot members 187 from C-shaped recesses 194. The anvil half-section 12, cartridge receiving half-section 14 and clamping lever 16 can now be sterilized, such as by autoclaving, and reused with a new SULU 18 and firing assembly 20 in the manner discussed above.
It will be understood that various modifications may be made to the embodiments of the surgical fastener applying apparatus disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

## Claims

1. A surgical fastener applying apparatus comprising:
an anvil half-section including a distal anvil portion and a proximal handle portion;
a cartridge receiving half-section defining an elongated channel member, the elongated channel member having a distal portion dimensioned to releasably receive a cartridge and a proximal portion configured to support a firing assembly, the cartridge receiving half-section further including a sidewall having an outer surface defining a bifurcated depression having a first depression portion and a second depression portion separated by a raised depression divider;
a clamping lever secured to the cartridge receiving half-section, the clamping lever having a proximal portion and a distal portion and including a handle portion,
the clamping lever being operably associated with the anvil half-section and the cartridge receiving half-section and being movable from an unclamped position to a clamped position to releasably secure the anvil portion of the anvil half-section in close approximation with the cartridge, wherein the clamping lever further includes a sidewall having an inner surface in opposition to the outer surface of the sidewall of the cartridge receiving half-section, the inner surface having a protrusion, the protrusion being positionable within the first depression portion of the bifurcated depression to releasably retain the clamping lever in the unclamped position and the protrusion being positionable within the second depression portion of the bifurcated depression to releasably retain the clamping lever in the clamped position.

2. The surgical fastener applying apparatus according to claim 1, wherein the clamping lever is releasably secured to the cartridge receiving half-section.

3. The surgical fastener applying apparatus according to claim 1, further including a firing assembly, the firing assembly configured to be releasably secured within the proximal portion of the cartridge receiving half-section and including a firing lever and a cam bar fixedly secured to the firing lever.

4. The surgical fastener applying apparatus according to claim 3, wherein the firing assembly further includes a stationary housing, the stationary housing being configured to be releasably supported in the proximal portion of the cartridge receiving portion.

5. The surgical fastener applying apparatus according to claim 4, wherein the stationary housing includes a U-shaped frame including a bottom wall and a pair of sidewalls, each of the sidewalls having a proximal end having a firing assembly protrusion, each of the firing assembly protrusions being positioned to be releasably received in a recess formed in the proximal end of the elongated channel member to releasably retain the stationary housing within the proximal portion of the elongated channel member.

6. The surgical fastener applying apparatus according to claim 5, wherein the firing assembly further includes a knife actuating bar which is configured to engage a knife supported within a cartridge received in the cartridge receiving half-section.

7. The surgical fastener applying apparatus according to claim 1, wherein the protrusion includes a flat sidewall which abuts the raised depression divider when the clamping lever is in the clamped position.

8. The surgical fastener applying apparatus according to claim 1, wherein the protrusion is deformable and passes over the raised depression divider when the clamping lever is moved between the unclamped position and the clamped position.

9. The surgical fastener applying apparatus according to claim 1, wherein the clamping lever is pivotally secured to the cartridge receiving half-section, and is pivotal to move the protrusion from the first depression portion of the bifurcated depression over the raised depression divider into the second depression portion of the bifurcated depression.

10. The surgical fastener applying apparatus according to claim 1, wherein the cartridge receiving half-section includes a pair of pivot members, each pivot member having a flat surface.

11. The surgical fastener applying apparatus according to claim 10, wherein the clamping lever includes a pair of C-shaped recesses, each C-shaped recess having a width smaller than a diameter of the pivot member such that the pivot members need to be slid into the C-shaped recesses along the flat surfaces to attach the clamping lever to the cartridge receiving half-section.

12. The surgical fastener applying apparatus according to claim 11, wherein the clamping lever is at a first angle with respect to the cartridge receiving half-section to attach the clamping lever to the cartridge receiving half-section and is at a second smaller angle with respect to the cartridge receiving half-section in the unclamped position.

13. The surgical fastener applying apparatus according to claim 10, wherein the flat surface is positioned at a proximal surface of the pivot member.

14. The surgical fastener applying apparatus according to claim 1, wherein the cartridge receiving half-section has a pair of U-shaped recesses to receive lateral support members of the anvil half-section.

15. The surgical fastener applying apparatus according to claim 14, wherein the U-shaped recesses are distal of the bifurcated depression.

16. The surgical fastener applying apparatus according to claim 14, wherein the cartridge receiving half-section includes a pair of pivot members, the pivot members positioned distal of the bifurcated depression.

17. The surgical fastener applying apparatus according to claim 1, wherein the first and second depression portions are of different configurations.

18. The surgical fastener applying apparatus according to claim 1, wherein a height of the first and second depression portions exceeds a diameter of the protrusion.