Surgical fastener applying apparatus

ES 2 398 538 T3

DESCRIPTION

Surgical Fastener Application Apparatus

BACKGROUND

1. Technical field

The present disclosure relates to surgical fastener applicators and, more particularly, to surgical fastener applicators for sequentially applying a plurality of surgical fasteners to body tissue.

2. Description of Related Art

Surgical devices are well known in the art in which tissue is first grasped or squeezed between opposing jaw structures and then attached by means of surgical fasteners. In some such instruments, a blade is arranged to cut the tissue that has been joined by the fasteners. The fasteners are typically in the form of surgical staples, however other surgical fasteners may also be used, for example metal points or two-part polymer surgical fasteners.

Instruments for applying surgical fasteners typically include two elongated arm members that are used, respectively, to capture or squeeze tissue therebetween. Typically, one of the arm members carries a disposable cartridge that houses a plurality of staples arranged in at least two lateral rows, while the other arm member comprises an anvil that defines a surface to form the legs of the staple, as the staples are driven from the cartridge. In the case where two-part fasteners are used, said arm member carries the mating part, for example the receiver element, for the fasteners driven from the cartridge. In general, the staple formation process is effected by the interaction between a longitudinally movable camming surface and a series of individual staple pusher members. As the camming surface moves longitudinally through the cartridge support member, the individual pusher members are laterally loaded by acting on the staples to sequentially eject them from the cartridge. A blade can be moved with the pusher between the rows of staples to longitudinally cut tissue between the rows of formed staples. In US Patent No. 3,079,606 and US Patent No. No. 3,490,675 describes examples of such instruments.

A later dated stapler described in US Patent No. 3,499,591 applies a double row of staples to each side of the incision. This is accomplished by providing a cartridge assembly in which a cam member moves through an elongated guide path between two sets of splines carrying staggered staples. The staple driving members are located within the grooves and are positioned such that the longitudinally movable cam contacts them to effect staple ejection.

US Patent No. 5,908,427 describes a replaceable staple cartridge assembly according to the preamble of claim 1.

SUMMARY

An object of the present invention is to provide a surgical fastener application apparatus, which apparatus will not discharge if a disposable staple cartridge is not properly loaded within the apparatus or is not fully loaded into the apparatus.

Another object of the present invention is to provide a surgical fastener application apparatus that will not open during the discharge stroke of the apparatus.

A further object of the present invention is a surgical fastener application apparatus that will not accept a fully discharged or partially discharged disposable staple cartridge therein.

Yet another object of the present invention is to provide a surgical fastener applying apparatus that will not discharge while in a loosening state.

The present invention provides a replaceable staple cartridge assembly as defined in claim 1.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the disclosed surgical fastener application apparatus will be described herein with reference to the accompanying drawing figures, in which:

Figure 1 is a perspective view of one embodiment of a surgical fastener apparatus constructed in accordance with the present disclosure;

Figure 2 is a top plan view of the embodiment of Figure 1;

Figure 3 is a side elevational view of the embodiment of Figure 1;

Figure 4 is a side elevation view of the embodiment of Figure 1, taken from the opposite side to that shown in Figure 3;

Figure 5 is a bottom plan view of the embodiment of Figure 1;

Figure 6 is a front elevation view of the embodiment of Figure 1;

Figure 7 is a rear elevational view of the embodiment of Figure 1;

Figure 8 is a perspective view of a disposable staple cartridge assembly of the disclosed surgical fastener applying apparatus;

Figure 9 is a perspective view, parts separated, of the disposable staple cartridge assembly of Figure 8;

Figure 10 is a schematic view of a pair of staple pushers;

Figure 11 is an enlarged-scale distal perspective view from the left of a staple cartridge loading and locking mechanism;

Figure 12 is a perspective proximal view, from the right side and on an enlarged scale, of the loading and locking mechanism of Figure 11;

Figure 13 is a perspective view, broken away, showing installation of a staple cartridge assembly over a cartridge half-section of the disclosed surgical fastener application apparatus;

Figure 14 is an enlarged perspective view from the bottom of the loading and locking mechanism with a staple cartridge in place thereon;

Figure 15 is an enlarged perspective view similar to Figure 12, with a staple cartridge in place;

Figure 16 is an enlarged side perspective view showing the relative positioning of the loading and locking mechanism with a staple cartridge installed and with an anvil half section in place in a tight condition;

Fig. 17 is a perspective view showing a surgical stapling apparatus after partial or complete discharge in a loosening state with a staple cartridge safety lock piece in a locked position;

Figure 18 is an enlarged-scale view of the indicated area of ​​detail of Figure 17;

Figure 19 is a perspective view of the surgical stapling apparatus open from one side of the anvil half section, a clamp lever of the anvil half section being open and a clamp lever of the cartridge half section closed;

Figure 20 is a perspective view of the surgical stapling apparatus open from one side of the cartridge half section, a cartridge half section clamping lever being open and a cartridge half section clamping lever closed;

Figure 21 is a perspective view, with parts broken away, showing the structural relationship of the various components of a clamping lever lock and safety interlocking mechanism;

Figure 22 is a plan view looking down the anvil half-section of the surgical stapling apparatus with a release lever in the most proximal position;

Figure 23 is a cross-sectional view taken along section line 23-23 of Figure 22;

Figure 24 is an enlarged view of the indicated area of ​​detail of Figure 23;

Figure 25 is a view, on an enlarged scale, of the indicated area of ​​detail of Figure 23;

FIG. 26 is a plan view, similar to FIG. 22, showing the release lever advanced distally a small distance;

Figure 27 is a cross-sectional view taken along section line 27-27 of Figure 26;

Figure 28 is a view, on an enlarged scale, of the indicated area of ​​detail of Figure 27;

Figure 29 is a view, on an enlarged scale, of the indicated area of ​​detail of Figure 27;

Figure 30 is a perspective view of the cartridge half section of the surgical stapling apparatus;

Figure 31 is a perspective view of a disposable staple cartridge assembly in accordance with an alternate embodiment of the present invention;

Figure 32 is a perspective view, parts broken away, of the disposable staple cartridge assembly of Figure 31;

Figure 33 is a perspective view of the disposable staple cartridge assembly, as shown in Figure 31, with the shipping wedge removed therefrom;

Figure 34 is a perspective view of a cartridge half section in accordance with the alternative embodiment of the present invention;

Figure 35 is an enlarged-scale distal perspective view from the left of a staple cartridge loading and locking mechanism;

Figure 36 is a perspective proximal view, from the right side and on an enlarged scale, of the loading and locking mechanism of Figure 35;

Figure 37 is an enlarged-scale perspective view as viewed from the bottom of the loading and locking mechanism, in accordance with the alternate embodiment of the present invention, with a staple cartridge in place thereon;

Figure 38 is an enlarged, partially exploded, perspective view as viewed from the bottom of the loading and locking mechanism shown in Figure 37;

Figure 39 is an enlarged perspective view similar to Figure 36, with a staple cartridge in place;

Figure 40 is an enlarged side perspective view showing the relative positioning of the loading and locking mechanism with a staple cartridge installed and with an anvil half-section in place in a tight condition;

Fig. 41 is a perspective view of the surgical stapling apparatus opened from one side of the anvil half section, a clamp lever of the anvil half section being open and a clamp lever of the cartridge half section closed;

Figure 42 is a perspective view of the surgical stapling apparatus open from one side of the cartridge half section, a cartridge half section clamping lever being open and a anvil half section clamping lever closed;

Figure 43 is a perspective view, with parts broken away, showing the structural relationship of the various components of a clamping lever lock and safety interlocking mechanism;

Figure 44 is a cross-sectional view of the surgical stapler taken along its longitudinal center line;

Figure 45 is an enlarged view of the indicated area of ​​detail of Figure 44;

Figure 46 is an enlarged view of the indicated area of ​​detail of Figure 44;

Figure 47 is a cross-sectional view of the surgical stapler taken along its longitudinal center line;

Figure 48 is an enlarged view of the indicated area of ​​detail of Figure 47;

Figure 49 is an enlarged view of the indicated area of ​​detail of Figure 47;

ES 2 398 538 T3 Figure 50 is a perspective view of the cartridge half section of the surgical stapling apparatus after partial or complete discharge with a safety locking piece of the staple cartridge in a locked position; and Figure 51 is a perspective view of the surgical stapling apparatus open both from the side of the cartridge half-section, the clamping lever of the cartridge half-section being open, and from the side of the anvil half-section, the lever being open. tightening of the anvil half section.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the disclosed surgical fastener apparatus will now be described in detail with reference to the drawing figures, in which like reference numerals identify similar or identical structural elements. As shown in the drawings and set forth throughout the following description, which is common when referring to relative positioning on a surgical instrument, the term "proximal" refers to the end of the apparatus that is closest to the user and the term "Distal" refers to the end of the apparatus that is furthest from the user.

Referring initially to Figure 1, an illustrative embodiment of the disclosed surgical fastener apparatus is illustrated therein and is generally referred to as a surgical stapler 10. The surgical stapler 10 is particularly adapted to apply a plurality of rows adjacent staples to body tissue squeezed in between the two main sections of the instrument, a receiving cartridge half-section 12 and an anvil half-section 14. Typical applications of the disclosed surgical fastener apparatus include, for example, the creation of a hemostatic seal in general, thoracic, and urologic surgery for resection, transection, and anastomosis creation. Specific tissue structures where the instrument can be used are, for example, the stomach, large and small intestines, lungs, and esophagus.

Figures 1 through 7 illustrate a preferred overall ornamental design for the disclosed surgical fastener application apparatus, in which each of these various figures shows a surgical stapler 10 with an anvil tip removed to illustrate the procedure. extreme cross-sectional profile of the anvil half-section. The anvil tip is the same as the tip at the distal end of the staple cartridge.

Referring to Figures 8-10, surgical stapler 10, which is designed for use with a disposable staple cartridge assembly, such as a disposable single-use loading unit ("SULU") 16, includes a body. 18 of the cartridge, a plurality of staple pusher members 20, a bottom cap 22, a blade 24 having an angled sharp leading edge 24a, a plurality of staples 26, a pivotally mounted safety lock piece 28 and a removable transport wedge 30. As in the case of known staple cartridge designs, the cartridge body 18 has a plurality of rows of staple retention slots 32 formed in the same. Surgical stapler 10 can be manufactured and assembled in different sizes to receive SULU 16s of different sizes. For example, surgical stapler 10 can be made in different sizes to accept SULUs having staple line lengths of 60mm, 80mm, and 100mm.

Alternatively, the SULUs 16 may be adapted such that a common surgical stapler 10 accepts multiple SULUs of different staple counts. For example, SULUs 16 may be configured so that each SULU of different staple count shares a common size cartridge body 18 to facilitate mounting to surgical stapler 10.

In the illustrated embodiment, there are two staggered rows of grooves 32 formed on each side of a linear grooved track 34 that guides blade 24 during its longitudinal movement. A single staple 26 is positioned in each of the slots 32. The rows of staples preferably extend a certain distance distally beyond the distal end of blade track 34 to facilitate formation of the staples beyond the blade stroke length 24.

Each of the staple pushers 20 are aligned with the slots 32 such that a single staple pusher 20 is positioned below the staple 26 retained in the slot 32. The staple pushers 20 are formed so that they are fixed between yes in groups of two pairs of offset-oriented pushers, shown schematically in Figure 10, and have an actuation surface connecting each pair of two pushers 20.

The pairs of pushers are arranged in two series, one on each side of the slotted track 34, such that the actuation surfaces of each series of pairs of pushers form a centered line between the staggered row of staples 26. The actuation surfaces act as cam followers and interact with a pair of stepped camming surfaces 36, 38 (see FIG. 11) that extend from a channel 40 of the cam bar to eject the pairs of staples 26 into each side of blade track 34. As illustrated, the camming surfaces 36, 38 form a single angle relative to the horizontal. In certain applications, for example with staples having an unformed leg height of approximately 4.5mm, the action surfaces

ES 2 398 538 T3 per cam 36, 38 may be formed by a plurality of angles to facilitate optimal deformation of the staples with a given discharge force. Since cam channel 40 is distally displaced, this sequence is repeated until distal movement of cam 40 is intentionally stopped by the user to form fewer than all of the staples 26 or until they are ejected. all SULU 26 staples

16.

The lower cap 22 partially closes the bottom of a channel formed by the upper surface and the side walls of the cartridge body 18. A longitudinal ridge 22a is formed on the upper surface of the lower cap 22 and serves as a bearing surface for the blade bearing channel 42, secured to the lower edge of the blade 24, as it travels on the blade track 34 . A pair of grooves are formed, one on each side of the longitudinal ridge 22a. The outer limit of each slot is defined by the outer wall of the cartridge body 18 on the respective side of the ridge 22a. Said grooves facilitate the alternating longitudinal movement of the extensions of the camming surfaces 36, 38 of the channel 40 of the cam bar. The blade support channel 42, which is wider than the blade track 34, is secured to the lower surface of the blade such that the blade support channel member 42 circulates between the track 34 of the blade. blade and longitudinal ridge 22a of bottom cap 22. In this manner, blade 24 is prevented from experiencing substantial vertical movement during longitudinal movement in blade track 34.

Safety locking member 28 is pivotably disposed at the upper proximal end of cartridge body 18 and is movable from a locked orientation to an unlocked orientation. Preferably, the safety locking member 28 is loaded away from the locked orientation toward an orientation substantially perpendicular to the longitudinal axis of the cartridge body 18. Any suitable load member may be used such as, for example, springs 44, 46. To overcome the load towards the perpendicular orientation, the safety lock piece 28 includes a horizontal transverse surface 28a (see FIG. 24) formed at its underside, engaging a hook 24b formed on the upper edge surface of blade 24. This collaborative application serves to retain the safety lock piece 28 in the locked orientation, in which the piece 28 covers the blade 24.

When the surgical stapler 10 has been untightened, as will be described in further detail further herein, after partial or complete discharge, the safety lock piece 28 is loaded toward the perpendicular orientation (see Figures 17 and 18), extending upward away from cartridge half-section 12. In this way, the surgical stapler 10 cannot be re-tightened until the partially or completely discharged SULU 16 is removed and replaced with a new SULU 16. The safety lock piece 28 also provides a gripping surface 28b with cutouts, whereby the SULU 16 can be easily removed from the surgical stapler 10.

As previously noted, the transport wedge 30 can be removably attached to the cartridge body 18. When installed in the SULU 16, the transport wedge 30 covers the entire surface area of ​​the staple rows 26 and the blade track 34. Additionally, the transport wedge 30 includes an abutment 30a that extends upwardly and proximally from the upper proximal surface of said transport wedge 30. The abutment 30a, in collaboration with the safety locking piece 28, covers the sharp distal edge 24a of the blade 24. This feature prevents the blade from being exposed to the user during manipulation of the SULU 16. Additionally, the abutment The abutment 30a prevents a pivotal movement of the safety lock piece 28 from the locked orientation. Accordingly, even if the SULU 16 is properly loaded into the surgical stapler 10, the staples 26 cannot be discharged until the transport wedge 30 is first removed.

The transport wedge 30 also includes a protrusion 30b that extends downwardly from the underside near the proximal end. Protrusion 30b fits into a complementary shaped opening 18c made in cartridge body 18 at the proximal end of blade track 34. With the transport wedge 30 in place, the protrusion 30b blocks any potential distal movement of the blade 26. In an alternative embodiment, the SULU 16 may also be devoid of a blade in applications where it is desirable to perform non-transection stapling. In such an embodiment, the blade 26 is replaced with a starter as a replacement for the blade to interact with the safety lock piece 28.

The cartridge body 18 is provided with several molded surfaces to facilitate mounting and alignment of the SULU 16 with respect to the cartridge half-section 12 of the surgical stapler 10. Such alignment facilitating surfaces may be formed in any suitable position on the various components of the cartridge body 18, to correspond to complementary surfaces on the cartridge half-section 12. In the illustrated embodiment, surfaces 18a with positioning / alignment features are formed extending downwardly on each side of the SULU 16, near its proximal end, and molded surfaces 18b are formed on each side of the cartridge body 18, near from its distal end. When the SULU 16 is properly installed in the surgical stapler 10, the surfaces 18a seat in a pair of notches 48, 50 (see FIG. 13) formed in the cartridge half-section 12.

ES 2 398 538 T3

Referring to Figures 11 to 16, a loading and locking mechanism for the SULU 16 will now be described in detail. In these figures, a channel frame 12a (see Figure 21) of the cartridge half-section 12 is not shown. , so that the loading and locking mechanism can be illustrated more clearly. The loading and locking mechanism facilitates loading of the SULU 16 and prevents unloading of the surgical stapler 10, until said SULU 16 is properly loaded onto the cartridge half-section 12 and said surgical stapler 10 is properly clamped closed. The loading and locking mechanism includes a rocker 52 which is pivotally mounted on the channel frame 12a (see FIG. 21) of the cartridge half-section 12 by means of projecting portions 52a that extend transversely and seat in openings formed through through the side walls of the channel frame 12a. The protrusions 52a are provided with angled downwardly facing surfaces to facilitate mounting of the rocker 52 with the channel frame 12a. Rocker 52 is preferably a molded plastic component and is provided with three grooves, namely, open bottom grooves 52b, 52c to allow longitudinal movement of cam channel 40 and a closed groove 52d to allow passage. of a central bar 54.

As best shown in Figures 12 and 14, rocker 52 is further provided with a downwardly extending locking surface 52e in vertical alignment with an opening formed through the lower surface of cam channel 40. , when the channel 40 of the cam bar is in its most proximal position. The rocker 52 is loaded, by means of a spring 56 disposed between a downwardly extending leg 52f and an end wall 58a of an arm member 58, toward a locked position in which the locking surface 52e extends through of the opening 40a. In this manner, cam bar channel 40 is prevented from experiencing distal longitudinal movement. In versions of surgical stapler 10 that use shorter SULU 16s, arm 58 can be removed.

Upon loading of the SULU 16 into the cartridge half section, as shown in Figures 15 and 16, spring loading maintains the rocker 52 in the locked position. It is only when the anvil half section 14 is joined with the cartridge half section 12 and the half sections are tightened together, thereby causing the downwardly extending leg portions 60a formed on each side of the channel member 60 of the anvil half-section are loaded against the SULU 16, that the rocker 52 is urged to rotate by camming the proximal end surface of the SULU 16 against the distal end surface of said rocker 52. In this manner, the locking surface 52e is brought out of longitudinal alignment with the opening 40a in the channel 40 of the cam bar, thereby allowing its distal longitudinal movement.

Referring to Figures 17 and 18, once the surgical stapler 10 has been discharged, at least partially, if the instrument is opened, the safety locking piece 28 of the SULU 16 automatically moves to the perpendicular orientation due to the mounting on it of the spring load. In this orientation, the surgical stapler 10 cannot be retightened. Accordingly, if the user wishes to apply additional staples, the SULU 16 must first be removed and replaced with a non-discharged SULU 16.

Referring to Figures 19 to 21, the surgical stapler 10 is provided with selectable double clamping levers 62, 64 and a pivotally mounted release lever 65. The clamping levers 62, 64 provide the user with the new exclusive option of opening the surgical stapler 10 from any half-section 12 or 14. Additionally, unload lever 65 provides the user with the ability to unload surgical stapler 10 from either left or right side.

Clamp levers 62, 64 are pivotally mounted on cartridge half section 12 and anvil half section 14, respectively. A pair of ergonomic contoured handles 66, 68 are secured to clamp levers 62, 64, respectively, to provide the user with a convenient grip handle. To further improve the grip of the surgical stapler 10 by the user, a pair of friction enhancing inserts 70, 72 are secured to the handles 66, 68. The inserts 70, 72 can be formed of any suitable friction enhancing material, eg, rubber. Half sections 12 and 14 are preferably configured and dimensioned to provide the user with the ability to wrap around both halves and comfortably close surgical stapler 10 with a single hand operation to approximate captured tissue.

Referring to Figures 21 to 23, 25 to 27 and 29, a clamping and safety interlocking element engagement mechanism is provided at the proximal end of surgical stapler 10. The clamping and safety interlocking element engagement mechanism serves to retain the clamping levers 62, 64 in a tight orientation, as well as to provide a safety interlock that prevents the opening of any clamping lever 62, 64 an time the release lever 65 is distally displaced. Each half section 12 and 14 is provided with a clamping and safety interlock assembly which is essentially the same and which works to engage the clamping levers 62, 64 in a tight configuration after depressing said clamping levers 62, 64 to the closed position. Accordingly, the following description of the various components that make up the assembly will be directed to those of the cartridge half-section 12, as shown in Figure 21.

ES 2 398 538 T3

The latch and safety latch engagement mechanism includes a distal latch 74 for the pinch levers and a proximal latch latch 76 that is spring loaded distally toward a latched position. When the surgical stapler 10 is in the tight configuration with the release lever 65 in the most proximal position, a slide release block 78 loads the latch 76 proximally to overcome distal spring loading, as shown in Figure 25. , to move a shoulder 76a of latch 76 out of lateral alignment with a proximal shoulder 74a formed on latch 74, thereby placing latch 76 in a disengaged position. In this position, the user can loosen any clamping lever 62, 64 by depressing spring-loaded finger pad portions 80a, 80b of latch handle release member 80 which pushes latch 74 proximally that the distal shoulder 74b is brought out of lateral alignment with the locking structure formed on the cartridge half-section 12a or the anvil half-section 14a (not shown).

Once release lever 65 is moved distally to begin the release sequence of surgical stapler 10, as shown in Figures 26, 27, and 29, slide block 78 is also moved distally thereby eliminating the loading force that exceeded the distal spring load of the hitch 76. Consequently, shoulder 76a comes into lateral alignment with shoulder 74a of latch 74, thereby preventing clamp lever 62 from opening until release lever 65 is moved, once again, to the most proximal position. The instrument is therefore prevented from opening during the discharge stroke.

After the initial distal movement, the release lever 65 becomes locked against any pivoting movement, by the fact that the release lever 65 is cam-driven downward to overcome an upward spring load, as shown in the Operatively progressive views of Figures 25 and 29. In particular, as best shown in Figure 30, recessed notches 65a, 65b are formed as keyways engaging a key 78a formed on slide block 78, respectively, depending on side discharge lever 65 being rotated. during the download. Release lever 65 can be returned to the most proximal position at any time during the release stroke. Release lever 65 must be returned to the most proximal position before the levers can be released and the instrument untightened. As previously described, if the instrument is opened after partial or complete discharge, the safety lock 28 on the SULU 16 is configured to prevent the user from re-tightening the instrument.

Turning now to Figures 31 through 51, an alternate embodiment of a disposable staple cartridge assembly is shown generally at 116. The staple cartridge assembly 116 includes a cartridge body 118, a plurality of staple pusher members 120, a bottom cap 122, a blade 124 having an angled sharp leading edge 124a, a plurality of staples 126, a pivotally mounted safety lock 128 and a removable transport wedge 130. As is the case with known staple cartridge designs, the cartridge body 118 has a plurality of rows of staple retention slots 132 formed therein.

Alternatively, cartridge assembly 116 may be adapted such that a common surgical stapler 100 (see Figures 41 and 42) accepts multiple cartridge assemblies 116 of different staple counts. For example, cartridge assemblies 116 may be configured so that each cartridge assembly 116 of different staple count shares a cartridge body 118, of common size, to facilitate mounting to surgical stapler 100.

In the present illustrated embodiment, there are two staggered rows of grooves 132 formed on each side of a linear grooved track 134 that guides blade 124 during its longitudinal movement. A single staple 126 is located in each of the slots 132. The rows of staples preferably extend a certain distance distally beyond the distal end of the blade track 134 to facilitate formation of the staples beyond the length of the stroke of the blade 124. The staple pushers 120 they are formed so that they are fixed to each other in groups of two pairs of displacement oriented pushers.

The pairs of pushers are arranged in two series, one on each side of the slotted track 134, such that the actuation surfaces of each series of pairs of pushers form a centered line between the staggered row of staples 126. The actuation surfaces act as cam followers and interact with a pair of stepped camming surfaces 136 and 138 (see Figures 34 to 36) that extend from a pair of cam bars 140 to eject the pairs of staples 126 on each side of blade track 134. As illustrated, the camming surfaces 136 and 138 form a single angle relative to the horizontal. Since each cam bar 140 is distally displaced, this sequence is repeated until the distal movement of each cam bar 140 is intentionally stopped by the user to form fewer than all of the staples 126 or until all of the staples are expelled. staples 126 of cartridge assembly 116.

The lower cap 122 partially closes the bottom of a channel formed by the upper surface and the side walls of the cartridge body 118. A longitudinal ridge 122a is formed on the upper surface of the lower cap 122 and serves as a bearing surface for the blade bearing channel 142, secured to the lower edge of the blade 124, as said blade 124 travels on the track 134 of the blade. They are formed a

ES 2 398 538 T3 pair of grooves, one on each side of longitudinal ridge 122a. The outer boundary of each slot is defined by the outer wall of the cartridge body 118 on the respective side of the ridge 122a. Said grooves facilitate the alternating longitudinal movement of the extensions of the camming surfaces 136, 138 of each cam bar 140. The blade support channel 142, which is wider than the blade track 134, is secured to the lower surface of the blade such that the blade support channel member 142 circulates between the track 134 of the blade. blade and longitudinal ridge 122a of bottom cap 122. In this manner, blade 124 is prevented from experiencing substantial vertical movement during longitudinal movement in blade track 134.

Safety lock member 128 is pivotably disposed at the upper proximal end of cartridge body 118 and is movable from a locked orientation to an unlocked orientation. Preferably, the safety lock member 128 is loaded away from the locked orientation toward an orientation substantially perpendicular to the longitudinal axis of the cartridge body 118. Any suitable loading member may be used such as, for example, a spring 144. To overcome the load towards the perpendicular orientation, the safety lock member 128 includes a horizontal transverse surface 128a (see FIG. 45) formed on its underside. , which engages a hook 124b formed on the upper edge surface of blade 124. This helper application serves to retain the safety lock piece 128 in the locked orientation, when said piece 128 covers the blade 124.

When the surgical stapler 100 has been untightened, as will be further described in further detail herein, after partial or complete discharge, the safety lock member 128 is loaded toward the perpendicular orientation (see FIG. 50), extending toward up away from cartridge half section 112. In this manner, surgical stapler 100 cannot be re-tightened until partially or completely discharged cartridge assembly 116 is removed and replaced with a new cartridge assembly 116. Safety lock member 128 also provides a gripping surface 128b with cut-out areas, whereby cartridge assembly 116 can be easily removed from surgical stapler 100.

As previously noted, the transport wedge 130 can be removably attached to the cartridge body 118. When installed in cartridge assembly 116, transport wedge 130 covers the entire surface area of ​​staple rows 126 and blade track 134. The transport wedge 130 includes a protrusion 130b that extends downwardly from the underside near its proximal end. Protrusion 130b fits into a complementary shaped opening 118c made in cartridge body 118 at the proximal end of blade track 134. With the transport wedge 130 in place, the protrusion 130b blocks any potential distal movement of the blade 126. The protrusion 130b keeps the blade 134 retained within the safety locking piece 128, thereby ensuring that the sharp distal edge 124a of blade 124 is covered. Again, the cartridge assembly 116 may be devoid of a blade in applications where it is desirable to perform non-transection stapling. In such an embodiment, the blade 126 is replaced with a starter as a replacement for the blade to interact with the security lock 128.

Cartridge body 118 includes a series of finger grip portions 127 formed along the upper sides of body 118 near its proximal end. Finger gripping portions 127 assist the user in gripping cartridge assembly 116 both for installation of cartridge assembly 116 in cartridge half section 112 and for removal. Cartridge body 118 also includes a pair of friction retaining pawls 129 disposed on each side near its proximal end. The friction retaining claws 129 are configured and adapted to project outwardly from the cartridge body 118 and to frictionally engage the interior surface of the cartridge half-section 112. In this manner, friction retaining claws 129 prevent cartridge assembly 116 from falling out of cartridge half-section 112.

Referring to Figures 35-40, a loading and locking mechanism for cartridge assembly 116 will now be described in detail. The loading and locking mechanism facilitates loading of cartridge assembly 116 and prevents discharge of the surgical stapler. 100 until cartridge assembly 116 is properly loaded onto cartridge half section 112 and surgical stapler 100 is properly snapped closed. The loading and locking mechanism includes a rocker arm 152 that is pivotally mounted on the channel frame 112a (see FIG. 43) of the cartridge half-section 112 by means of projecting portions 152a which extend transversely and seat in openings formed through through the side walls of the channel frame 112a. Protruding portions 152a are provided with angled downwardly facing surfaces to facilitate mounting of rocker 152 with channel frame 112a. Rocker 152 is preferably a molded plastic component and is provided with three slots, namely, open bottom slots 152b, 152c to allow longitudinal movement of the cam bar channel 140 and a closed slot 152d to allow passage. of a central bar 154.

As best shown in Figures 37 and 39, rocker 152 is further provided with a downwardly extending locking surface 152e in vertical alignment with an opening 140a formed through the bottom surface of each cam bar 140, when each cam bar 140 is in its most proximal position. The rocker 152 is loaded, by means of a spring 156 disposed on the protruding portion 152a extending transversely and between a ridge 152f formed on one side of the rocker 152 and the upper surface of the cartridge half-section.

ES 2 398 538 T3

112 (see FIG. 35), toward a locked position in which locking surface 152e extends through aperture 140a. In this manner, each cam bar 140 is prevented from experiencing distal longitudinal movement.

After loading the cartridge assembly 116 into the cartridge half section 112, as shown in Figures 37-40, spring loading maintains the rocker arm 152 in the locked position. It is only when the anvil half section 114 is joined with the cartridge half section 112 and the half sections are squeezed together, thereby causing the downwardly extending leg portions 160a formed on each side of the channel member 160 of the anvil half-section are loaded against cartridge assembly 116, that rocker arm 152 is urged to rotate by camming the proximal end surface of cartridge assembly 116 against the distal end surface of rocker arm 152. In this manner, locking surface 152e is brought out of longitudinal alignment with the opening 140a of each cam bar 140, thereby allowing its distal longitudinal movement.

Similar to the first embodiment, once the surgical stapler 100 has been at least partially unloaded, if the instrument is opened, the safety locking piece 128 of the cartridge assembly 116 automatically moves to the perpendicular orientation due to mounting in the same of the spring load. In this orientation, surgical stapler 100 cannot be re-tightened. Accordingly, if the user wishes to apply additional staples, the discharged or partially discharged cartridge assemblies 116 must first be removed and replaced with a non-discharged cartridge assembly 116.

Referring to Figures 41 and 42, surgical stapler 100 is provided with selectable dual clamp levers 162 and 164 and a pivotally mounted release lever 165. Similar to pinch levers 62 and 64 of the first embodiment, pinch levers 162 and 164 of the present embodiment provide the user with the new exclusive option of opening surgical stapler 100 from either half section 112 or 114. Additionally, unload lever 165 provides the user with the ability to unload surgical stapler 100 from either the left or right side.

Clamp levers 162 and 164 are pivotally mounted on cartridge half section 112 and anvil half section 114, respectively. The clamp levers 162 and 164 provide the user with the ability to open the surgical stapler from the anvil half section 114, as seen in Figure 41, from the cartridge half section 112, as seen in Figure 42, or simultaneously both from the cartridge half section 112 as well as from the anvil half section 114, as seen in FIG. 51. A pair of ergonomic contoured handles 166 and 168 are secured to clamp levers 162 and 164, respectively, to provide the user with a convenient grip handle. To further improve the grip of surgical stapler 100 by the user, a pair of friction enhancing inserts 170 and 172 are secured to handles 166 and 168.

Unlike the first embodiment, the surgical stapler 100 according to the alternative embodiment does not have a safety interlock mechanism. In this manner, the user can open the surgical stapler 100 after a complete or partial discharge of the cartridge assembly 116. Referring now to Figures 43 through 49, a clamping element engagement mechanism, according to the alternative embodiment, is disposed at the proximal end of surgical stapler 100, which serves to retain clamping levers 162 and 164 in a tight orientation. Each half section 112 and 114 is provided with a clamping element engagement mechanism which is essentially the same and which works to engage the clamping levers 162 and 164 in a tight configuration after depressing said clamping levers 162 and 164 to the position closed. Accordingly, the following description of the various components that make up the clamping element engagement mechanism will be directed to those of the cartridge half section 112.

As shown in FIG. 43, the fastener engagement mechanism includes a distal engagement lever engagement 174, formed at the proximal end of the cartridge half-section 112, and a latch handle release member 180. , operatively coupled to the proximal end of clamp lever 162. The latch handle release member 180 is spring loaded proximally toward a latched position and is provided with a latch latch 182 for engaging latch 174 of the clamp levers. To release clamp lever 162, the user presses release member 180 in the distal direction, thereby disengaging locking latch 182 from latch 174.

In order to prevent inadvertent opening of clamp lever 162, release member 180 is provided with a protrusion 184 extending downwardly from its proximal end, which protrusion 184 is seated within a shield 186 formed at the proximal end. lever 162. It is envisioned that shield 186 may be integral with handles 166 and 168 and is made of a resilient material to allow the user to more easily displace shield 186 and thereby squeeze release member 180.

Furthermore, as seen in FIG. 43, the surgical stapler 100 is provided with a slide block 188 of the release lever. Sliding block 188 includes a central piece 190 protruding therefrom and that is configured and adapted to be received in a pivot hole 192 formed in release lever 165. Sliding block 188 is configured and adapted to be slidably received in cartridge half section 112 or anvil half section 114. When used, the dump lever 165 can pivot

ES 2 398 538 T3 around the center piece 190 thereby providing the user with the ability to manipulate the release lever 165 from each side of the surgical stapler 100.

As seen in Figures 41 through 43 and 50, surgical stapler 100 is provided with a staple gap adjustment mechanism 200 that allows each stapler 100 to be manufactured and assembled with a very precise 5 staple gap between the cartridge assembly and the anvil structure of the surgical stapler. According to the present embodiment, the gap adjustment mechanism 200 includes a pair of vertical hinge plates 202 formed along the sides of the cartridge half section 112 and an eccentric cam 206. Each hinge plate 202 is provided with a coaxial through hole. 204 formed therein and is configured and adapted to receive eccentric cam 206 therein. When used, as eccentric cam 206 is rotated, eccentric cam 206 pushes against anvil half section 114 until the desired staple gap is achieved between anvil half section 114 and cartridge half section 112. At which point the eccentric cam 206 is fixedly secured in the through holes 204.

It will be understood that various modifications can be made to the embodiments of the surgical fastener applying apparatus described herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will be able to envision other modifications within the scope of the present invention, as defined in the appended claims.