Staple cartridges for forming staples having differing formed staple heights

A staple cartridge for use with a stapling device that has an actuator that is selectively actuatable in an axial direction and an anvil portion that is selectively movable between open and closed positions is disclosed. Various embodiments of the present invention include a cartridge body that movably supports first and second staple drivers. The staple drivers each support a staple thereon and serve to drive the staples into forming contact with the anvil upon actuation by the actuator. The various embodiments of the present invention enable the final formed heights of the staples to be varied so as to apply various clamping forces and pressures to soft tissue captured within the staples. In at least one embodiment, the staples can include crowns formed thereon which can be utilized to adjust or control the clamping force and/or pressure applied by the staples.

FIELD OF THE INVENTION

The present invention relates in general to stapling instruments that are capable of applying lines of staples and, more particularly, to improvements relating to staple cartridges for use with surgical stapling instruments that are capable of applying lines of staples having differing formed staple heights to tissue while simultaneously cutting the tissue.

BACKGROUND OF THE INVENTION

Surgical staplers have been used in the prior art to simultaneously make a longitudinal incision in tissue and apply lines of staples on opposing sides of the incision. Such instruments commonly include a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges that, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications is described in U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVING SEPARATE AND DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21, 2006, the entire disclosure of which is hereby incorporated by reference herein. In use, a clinician is able to close the jaw members of the stapler upon tissue to position the jaw members prior to firing. Once the clinician has determined that the jaw members are properly gripping tissue, the clinician can then fire the surgical stapler, thereby severing and stapling the tissue. The simultaneous severing and stapling avoids complications that may arise when performing such actions sequentially with different surgical tools that respectively only sever or staple.

Whenever a transection of tissue is across an area of varied tissue composition, it would be advantageous for the staples that are closest to the cut line to have one formed height that is less than the formed height of those staples that are farthest from the cut line. In practice, the rows of inside staples serve to provide a hemostatic barrier, while the outside rows of staples with larger formed heights provide a cinching effect where the tissue transitions from the tightly compressed hemostatic section to the non-compressed adjacent section. In other applications, it may be useful for the staples in a single line of staples to have differing formed heights. U.S. Pat. Nos. 4,941,623 and 5,027,834 to Pruitt disclose surgical stapler and cartridge arrangements that employ staples that have different prong lengths to ultimately achieve lines of staples that have differing formed heights. Likewise, WO 2003/094747A1 discloses a surgical stapler and cartridge that has six rows of staples wherein the outer two rows of staples comprise staples that are larger than the staples employed in the inner two rows and middle rows of staples. Although the above-disclosed staples and staple cartridges may be suitable for their intended purpose, what is needed is an improvement over the foregoing.

BRIEF SUMMARY OF THE INVENTION

In at least one form of the invention, a staple cartridge can be configured to deploy staples in rows, where the staples in a first row can be deformed to a different height than the staples in a second row. In at least one embodiment, the staple cartridge can include a first driver for deploying a staple in the first row a first distance and a second driver for deploying a staple in the second row a second distance, wherein the first distance can differ from the second distance. Owing to the different distances in which the staples can be deployed, the staples can be deformed to various heights such that the staples within the first row can apply different clamping forces to soft tissue captured therein as compared to the staples within the second row.

In at least one form of the invention, a staple cartridge can include other various features which can deform staples to different heights and/or create different clamping forces within the staples. In various embodiments, the staples in a first row of a staple cartridge can include a crown, a tissue-contacting surface on the crown, and a deformable member extending from the crown, where a first distance can be defined between the tissue-contacting surface and a bottom surface of the crown. The staples in a second row of the staple cartridge can also include a crown, a tissue-contacting surface on the crown, and a deformable member, where a second distance can be defined between the tissue-contacting surface and a bottom surface of the crown. In at least one such embodiment, the first distance can differ from the second distance such that the first staples can apply a first force to tissue captured therein and the second staples can apply a second force, where the first force can differ from the second force.

In at least one form of the invention, the crowns of various staples can include tissue-contacting surfaces which can comprise contact areas across which soft tissue can be supported by the crowns. In various embodiments, such tissue-contacting surfaces can reduce the clamping pressure applied by the staples. In at least one embodiment, staples which are deformed to shorter heights and/or apply a larger clamping force can include larger tissue-contacting surfaces as compared to the tissue-contacting surfaces of staples which are deformed to taller heights and/or apply a smaller clamping force so as to substantially equalize, or at least control, the pressures applied by the staples to soft tissue captured within the staples, for example. As a result, embodiments are envisioned in which the size of the tissue-contacting area and/or the anticipated deformed staple height can be selected to provide a larger and/or smaller clamping pressure to a particular area of the treated tissue.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the Drawings, wherein like numerals denote like components throughout the several views,FIGS. 1 and 2depict one embodiment of a surgical stapling and severing instrument10that is capable of practicing the unique benefits of the present invention. As the present Detailed Description proceeds, the reader will appreciate, however, that the unique and novel aspects of the present invention may be advantageously employed in connection with a variety of other staplers and stapler instruments without departing from the spirit and scope of the present invention. Accordingly, the scope of protection afforded to the various embodiments of the present invention should not be limited to use only with the specific type of surgical stapling and severing instruments described herein.

As can be seen inFIGS. 1 and 2, the surgical stapling and severing instrument10incorporates an end effector12having an actuator or E-beam firing mechanism (“firing bar”)14that advantageously controls the spacing of the end effector12. In particular, an elongate channel16and a pivotally translatable anvil18are maintained at a spacing that assures effective stapling and severing. The problems are avoided associated with varying amounts of tissue being captured in the end effector12.

It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping a handle of an instrument. Thus, the end effector12is distal with respect to the more proximal handle portion20. It will be further appreciated that for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

The surgical and stapling and severing instrument10includes a handle portion20that is connected to an implement portion22, the latter further comprising a shaft23distally terminating in the end effector12. The handle portion20includes a pistol grip24toward which a closure trigger26is pivotally drawn by the clinician to cause clamping, or closing, of the anvil18toward the elongate channel16of the end effector12. A firing trigger28is farther outboard of the closure trigger26and is pivotally drawn by the clinician to cause the stapling and severing of clamped tissue in the end effector12.

In practice, closure trigger26is actuated first. Once the clinician is satisfied with the positioning of the end effector12, the clinician may draw back the closure trigger26to its fully closed, locked position proximate to the pistol grip24. Then, the firing trigger28is actuated. The firing trigger28springedly returns when the clinician removes pressure. A release button30when depressed on the proximal end of the handle portion20releases any locked closure trigger26.

A closure sleeve32encloses a frame34, which in turn encloses a firing drive member36that is positioned by the firing trigger28. The frame34connects the handle portion20to the end effector12. With the closure sleeve32withdrawn proximally by the closure trigger26as depicted, the anvil18springedly opens, pivoting away from the elongate channel16and translating proximally with the closure sleeve32. The elongate channel16receives a staple cartridge37.

With particular reference toFIGS. 2-4, the firing bar14includes three vertically spaced pins that control the spacing of the end effector12during firing. In particular, an upper pin38is staged to enter an anvil pocket40near the pivot between the anvil18and elongate channel16. When fired with the anvil18closed, the upper pin38advances distally within a longitudinal anvil slot42extending distally through anvil18. Any minor upward deflection in the anvil18is overcome by a downward force imparted by the upper pin38. Firing bar14also includes a lowermost pin, or firing bar cap,44that upwardly engages a channel slot45in the elongate channel16, thereby cooperating with the upper pin38to draw the anvil18and the elongate channel16slightly closer together in the event of excess tissue clamped therebetween. The firing bar14advantageously includes a middle pin46that passes through a firing drive slot47formed in a lower surface of the cartridge300and an upward surface of the elongate channel16, thereby driving the staples therein as described below. The middle pin46, by sliding against the elongate channel16, advantageously resists any tendency for the end effector12to be pinched shut at its distal end. To illustrate an advantage of the middle pin46,FIG. 5depicts an alternative end effector12′ that lacks a middle pin on a firing bar14′. In this depiction, the end effector12′ is allowed to pinch shut at its distal end, which tends to impair desired staple formation.

Returning toFIGS. 2-4, a distally presented cutting edge48between the upper and middle pins38,46on the firing bar14traverses through a proximally presented, vertical slot49in the cartridge37to sever clamped tissue. The affirmative positioning of the firing bar14with regard to the elongate channel16and anvil18assure that an effective cut is performed. The affirmative vertical spacing provided by the E-Beam firing bar14is suitable for the limited size available for endoscopic devices. Moreover, the E-Beam firing bar14enables fabrication of an anvil15with a camber imparting a vertical deflection at its distal end, similar to the position depicted inFIG. 5. This cambered anvil15advantageously assists in achieving the desired gap in the end effector12even with an anvil15having a reduced thickness, which may be more suited to the size limitations of an endoscopic device.

With reference toFIGS. 6-9, the handle portion20is comprised of first and second base sections50and52, which are molded from a polymeric material such as a glass-filled polycarbonate. The first base section50is provided with a plurality of cylindrically-shaped pins54. The second base section52includes a plurality of extending members56, each having a hexagonal-shaped opening58. The cylindrically-shaped pins54are received within the hexagonal-shaped openings58and are frictionally held therein for maintaining the first and second base sections50and52in assembly.

A rotating knob60has a bore62extending completely through it for engaging and rotating the implement portion22about its longitudinal axis. The rotating knob60includes an inwardly protruding boss64extending along at least a portion of the bore62. The protruding boss64is received within a longitudinal slot66formed at a proximal portion of the closure sleeve32such that rotation of the rotating knob60effects rotation of the closure sleeve32. It will be appreciated that the boss64further extends through frame34and into contact with a portion of the firing drive member36to effect their rotation as well. Thus, the end effector12(not shown inFIGS. 6-9) rotates with the rotating knob60.

A proximal end68of the frame34passes proximally through the rotating knob60and is provided with a circumferential notch70that is engaged by opposing channel securement members72extending respectively from the base sections50and52. Only the channel securement member72of the second base section52is shown. The channel securement members72, extending from the base sections50,52serve to secure the frame34to the handle portion20such that the frame34does not move longitudinally relative to the handle portion20. The closure trigger26has a handle section74, a gear segment section76, and an intermediate section78. A bore80extends through the intermediate section78. A cylindrical support member82extending from the second base section52passes through the bore80for pivotably mounting the closure trigger26on the handle portion20. A second cylindrical support member83extending from the second base section52passes through a bore81of firing trigger28for pivotally mounting on the handle portion20. A hexagonal opening84is provided in the cylindrical support member83for receiving a securement pin (not shown) extending from the first base section50.

A closure yoke86is housed within the handle portion20for reciprocating movement therein and serves to transfer motion from the closure trigger26to the closure sleeve32. Support members88extending from the second base section52and securement member72, which extends through a recess89in the yoke86, support the yoke86within the handle portion20.

proximal end90of the closure sleeve32is provided with a flange92that is snap-fitted into a receiving recess94formed in a distal end96of the yoke86. A proximal end98of the yoke86has a gear rack100that is engaged by the gear segment section76of the closure trigger26. When the closure trigger26is moved toward the pistol grip24of the handle portion20, the yoke86and, hence, the closure sleeve32move distally, compressing a spring102that biases the yoke86proximally. Distal movement of the closure sleeve32effects pivotal translation movement of the anvil18distally and toward the elongate channel16of the end effector12and proximal movement effects closing, as discussed below.

The closure trigger26is forward biased to an open position by a front surface130interacting with an engaging surface128of the firing trigger28. Clamp first hook104that pivots top to rear in the handle portion20about a pin106restrains movement of the firing trigger28toward the pistol grip24until the closure trigger26is clamped to its closed position. Hook104restrains firing trigger28motion by engaging a lockout pin107in firing trigger28. The hook104is also in contact with the closure trigger26. In particular, a forward projection108of the hook104engages a member110on the intermediate section78of the closure trigger26, the member100being outward of the bore80toward the handle section74. Hook104is biased toward contact with member110of the closure trigger26and engagement with lockout pin107in firing trigger28by a release spring112. As the closure trigger26is depressed, the hook104is moved top to rear, compressing the release spring112that is captured between a rearward projection114on the hook104and a forward projection116on the release button30. As the yoke86moves distally in response to proximal movement of the closure trigger26, an upper latch arm118of the release button30moves along an upper surface120on the yoke86until dropping into an upwardly presented recess122in a proximal, lower portion of the yoke86. The release spring112urges the release button30outward, which pivots the upper latch arm118downwardly into engagement with the upwardly presented recess122, thereby locking the closure trigger26in a tissue clamping position, such as depicted inFIG. 8.

The latch arm118can be moved out of the recess122to release the anvil18by pushing the release button30inward. Specifically, the upper latch arm118pivots upward about pin123of the second base section52. The yoke86is then permitted to move proximally in response to return movement of the closure trigger26.

A firing trigger return spring124is located within the handle portion20with one end attached to pin106of the second base section52and the other end attached to a pin126on the firing trigger28. The firing return spring124applies a return force to the pin126for biasing the firing trigger28in a direction away from the pistol grip24of the handle portion20. The closure trigger26is also biased away from pistol grip24by engaging surface128of firing trigger28biasing front surface130of closure trigger26.

As the closure trigger26is moved toward the pistol grip24, its front surface130engages with the engaging surface128on the firing trigger28causing the firing trigger28to move to its “firing” position. When in its firing position, the firing trigger28is located at an angle of approximately 45° to the pistol grip24. After staple firing, the spring124causes the firing trigger28to return to its initial position. During the return movement of the firing trigger28, its engaging surface128pushes against the front surface130of the closure trigger26causing the closure trigger26to return to its initial position. A stop member132extends from the second base section52to prevent the closure trigger26from rotating beyond its initial position.

The surgical stapling and severing instrument10additionally includes a reciprocating section134, a multiplier136and a drive member138. The reciprocating section134comprises a wedge sled in the implement portion22(not shown inFIGS. 6-9) and a metal drive rod140.

The drive member138includes first and second gear racks141and142. A first notch144is provided on the drive member138intermediate the first and second gear racks141,142. During return movement of the firing trigger28, a tooth146on the firing trigger28engages with the first notch144for returning the drive member138to its initial position after staple firing. A second notch148is located at a proximal end of the metal drive rod140for locking the metal drive rod140to the upper latch arm118of the release button30in its unfired position.

The multiplier136comprises first and second integral pinion gears150and152. The first integral pinion gear150is engaged with a first gear rack154provided on the metal drive rod140. The second integral pinion gear152is engaged with the first gear rack141on the drive member138. The first integral pinion gear150has a first diameter and the second integral pinion gear152has a second diameter which is smaller than the first diameter.

FIGS. 6,8and9depict respectively the handle portion20in the start position (open and unfired), a clamped position (closed and unfired) and a fired position. The firing trigger28is provided with a gear segment section156. The gear segment section156engages with the second gear rack142on the drive member138such that motion of the firing trigger28causes the drive member138to move back and forth between a first drive position, shown inFIG. 8, and a second drive position, shown inFIG. 9. In order to prevent staple firing before tissue clamping has occurred, the upper latch arm118on the release button39is engaged with the second notch148on the drive member138such that the metal drive rod140is locked in its proximal-most position, as depicted inFIG. 6. When the upper latch arm118falls into the recess122, the upper latch arm118disengages with the second notch148to permit distal movement of the metal drive rod140, as depicted inFIG. 9.

Because the first gear rack141on the drive member138and the gear rack154on the metal drive rod140are engaged with the multiplier136, movement of the firing trigger28causes the metal drive rod140to reciprocate between a first reciprocating position, shown inFIG. 8, and a second reciprocating position, shown inFIG. 9. Since the diameter of the first pinion gear150is greater than the diameter of the second pinion gear152, the multiplier136moves the reciprocating section134a greater distance than the drive member138is moved by the firing trigger28. The diameters of the first and second pinion gears150and152may be changed to permit the length of the stroke of the firing trigger28and the force required to move it to be varied. It will be appreciated that the handle portion20is illustrative and that other actuation mechanisms may be employed. For instance, the closing and firing motions may be generated by automated means.

One embodiment of an end effector12of the surgical stapling and severing instrument10is depicted in further detail inFIGS. 18,19, and23-26. As described above, the handle portion20produces separate and distinct closing and firing motions that actuate the end effector12. The end effector12advantageously maintains the clinical flexibility of this separate and distinct closing and firing (i.e., stapling and severing). In addition, the end effector12introduces the aforementioned ability to affirmatively maintain the closed spacing during firing after the clinician positions and clamps the tissue. Both features procedurally and structurally enhance the ability of the surgical stapling and severing instrument10by ensuring adequate spacing for instances where an otherwise inadequate amount of tissue is clamped and to enhance the clamping in instances where an otherwise excessive amount of tissue has been clamped.FIG. 10depicts a staple cartridge embodiment300of the present invention installed in the end effector12with the firing bar14in its unfired, proximal position. The staple cartridge300has a cartridge body302that is divided by an elongated slot310that extends from a proximal end304of the cartridge300towards a tapered outer tip306. A plurality of staple-receiving channels320a-320fare formed within the staple cartridge body302and are arranged in six laterally spaced longitudinal rows500,502,504,506,508,510, with three rows on each side of the elongated slot310. Positioned within the staple-receiving channels320a-320fare the staples222. SeeFIGS. 10 and 11.

The cartridge300further includes four laterally spaced longitudinal rows of staple drivers330a,330b,370a, and370bas shown inFIG. 11. The “first” inside staple drivers330aare slidably mounted within corresponding channels320band320csuch that each driver330asupports two staples222, one in a channel320band one in a channel320c. Likewise, the “second” inside drivers330bare slidably mounted within channels320dand320esuch that each driver330bsupports two staples222, one in a channel320dand one in a channel320e. The “outside” drivers370aand370bare slidably mounted within the staple-receiving channels320aand320f, respectively. Each of the outside drivers370aand370bsupports a single staple222. Drivers370aare referred to herein as “first” outside drivers and drivers370bare referred to herein as “second” outside drivers.

FIG. 12illustrates a staple222that may be used in connection with the various embodiments of the present invention. The staple222includes a main portion223and two prongs225. The prongs225each have a length “P” and the main portion has a width “W”. The reader will appreciate that a variety of different types of staples may be employed. For example, for a vascular staple, “P” may be approximately 0.102 inches; for a regular staple, “P” may be approximately 0.134 inches; and for a thick tissue staple, “P” may be approximately 0.160 inches. For all such staples, “W” may be approximately 0.120 inches. Other sizes of staples222may be employed in the manners discussed below.

The inside staple drivers330alocated on one side of the elongated slot310are referred to herein as “first” inside staple drivers and the inside staple drivers330blocated on the other side of the elongated slot310are referred to herein as “second” inside staple drivers. As will be discussed in further detail below, in one embodiment, the second inside staple drivers330bare identical to the first inside staple drivers330a, except for their orientation in their respective channels in the cartridge body302.

FIGS. 13-15illustrate one embodiment of a “first” inside double driver330afor supporting and driving staples222. As can be seen in those Figures, the staple driver330ahas a primary driver portion340and a secondary driver portion350that is connected to the first primary portion340by a central base member360. The primary driver portion340has a primary driver base342that has a groove343therein adapted to mate with a corresponding vertically extending tongue (not shown) in the cartridge body302for guiding and stabilizing the driver330aas it moves within its respective channel. The primary driver portion340further has a first forward support column344and a first rearward support column346protruding upward from the first driver base342. The first forward support column344has a first forward staple-receiving groove345therein and the first rearward support column346has a first rearwardly staple-receiving groove347therein. SeeFIGS. 13-15. The first forward support column344and the first rearward support column346are spaced from each other and collectively form a first staple cradle348for supporting the main portion223of the staple222therein.

Similarly, the secondary driver portion350has a secondary driver base352and a secondary forward support column354and a secondary rearward support column356protruding out from the second driver base352. The secondary forward support column354has a secondary forward staple-receiving groove355therein and the secondary rearward support column356has a secondary rearward staple-receiving groove357therein. The secondary forward support column354and the secondary rearward support column356are spaced from each other and collectively form a secondary staple cradle358for supporting the main portion223of another staple222therein.

As can be seen inFIGS. 13 and 15, the central base member360has an angled rearwardly facing edge362adapted to be engaged by a corresponding sled cam as will be discussed in further detail below. As can be seen inFIGS. 13 and 14, in this embodiment, the secondary forward support column354of the secondary driver portion is oriented relative to the first rearward support column346such that the staple222that is supported in the secondary staple cradle358is longitudinally offset from the staple222in the first staple cradle348. The reader will appreciate that the first inside drivers330aare each installed in one orientation into a corresponding pair of channels320band320clocated on one side of the elongated slot310in the cartridge body302. The second inside staple drivers330b(located on the opposite side of the elongated slot310from the first inside staple drivers330a) comprise inside drivers330arotated 180 degrees so that their respective angled surfaces363face towards the proximal end304of the cartridge300to enable them to be installed in pairs of corresponding channels320dand320e. Thus, in this embodiment, only one inside driver configuration is employed which thereby eliminates the need for two different inside staple driver configurations for channels on each side of the elongated slot310.

FIGS. 16 and 17illustrate one embodiment of a “first” outside staple driver370a. As can be seen in those FIGS., a first outside staple driver370ahas a second base372that has an angled rearwardly facing portion374. Protruding upward from the second base372is a second forward support column375that has a second forward staple-receiving groove376therein. A second rearward support column377also protrudes upward from the second base372in a spaced-apart relationship with respect to the second forward support column375. The second rearward support column377has a second rearward staple-receiving groove378therein. The support columns375,377collectively form a second staple cradle379that is configured to support a staple222therein as illustrated inFIGS. 16 and 17. The staple drivers370aalso have a laterally protruding rib371which is received in a corresponding groove (not shown) in the cartridge body302for guiding and stabilizing the driver370aas it moves within its respective channel.

The reader will appreciate that a first outside driver370ais installed in one orientation into a corresponding channel320aon one side of the elongated slot310. A second outside staple driver370b(to be located on the opposite side of the elongated slot310from the first outside staple drivers370a) comprises an outside driver370arotated 180 degrees so that the angled surface374′ thereon faces toward the proximal end304of the cartridge300to enable it to be installed in a corresponding channel320fin the cartridge body302. Thus, in this embodiment, only one outside staple driver configuration is employed which avoids the need for two different outside staple driver configurations for channels on each side of the elongated slot310.

FIGS. 19 and 19Aillustrate in cross-section one embodiment of a staple cartridge of the present invention mounted within one type of end effector12. The end effector12in this embodiment employs a “stepped” anvil18of the type illustrated inFIGS. 23-25. In other embodiments, however, the bottom surface of the anvil is planar and not stepped. Other As can be seen inFIGS. 19A, and23-25, the anvil18has a central portion19that is offset or not coplanar with the two lateral side portions21,23. Accordingly, in this embodiment, the upper surface306of the cartridge300is provided with a recessed central portion307and two lateral side portions309that are adapted to closely mate with the corresponding portions19,21,23, respectively, of the anvil18, when the anvil18is in the closed position. SeeFIG. 19A. As can be seen inFIG. 24, in this embodiment, the under surfaces200of anvil18are provided with a series of forming pockets202that may be arranged in rows that correspond to the rows of channels in the cartridge300. That is, row205of pockets202may correspond to channel row500. Row207of pockets may correspond to channel row502. Row209of pockets202may correspond to channel row504. Row211of pockets202may correspond to channel row506. Row213of pockets202may correspond to channel row508. Row215of pockets202may correspond to channel row510. Each pocket202has at least one forming surface203therein that is adapted to contact the ends of the staple prongs225being driven therein to thereby cause the prongs225to bend inwardly toward each other. In one embodiment, each pocket202has two intersecting arcuate forming surfaces203that are oriented as shown inFIG. 14A. Each arcuate forming surface has an apex203′ that defines a maximum pocket depth “Z”. However other forming pocket configurations could be employed.

Returning toFIGS. 18 and 19, it can be seen that in one embodiment, the cartridge body302is mounted within the cartridge tray224. As illustrated inFIG. 19, the cartridge body302is formed with two inside longitudinally extending slots390and two outside longitudinally extending slots392. Slots390and392extend from the proximal end304of the cartridge to its tapered outer tip306(shown inFIG. 10). This embodiment further includes a wedge sled400that slidably supported on the cartridge tray224. One wedge sled embodiment400includes a pair of inside sled cams410, wherein one inside sled cam410corresponds to one of the inside longitudinally extending slots390and wherein the other inside sled cam410corresponds to the other inside longitudinally extending slot390. SeeFIG. 19. The wedge sled400further includes a pair of outside sled cams420, wherein one outside sled cam420corresponds to one of the outside longitudinally extending slots392and the other outside sled cam420corresponds to the other outside longitudinally extending slot392as shown inFIG. 19. When assembled, the cartridge tray224holds the wedge sled400and the drivers330a,330b,370a,370binside the cartridge body302.

As can be seen inFIG. 18, the elongate channel16has a proximally placed attachment cavity226that receives a channel anchoring member228on the distal end of the frame34for attaching the end effector12to the handle portion20. The elongate channel16also has an anvil cam slot230that pivotally receives an anvil pivot232of the anvil18. The closure sleeve32that encompasses the frame34includes a distally presented tab234that engages an anvil feature236proximate but distal to the anvil pivot232on the anvil18to thereby effect opening and closing of the anvil18. The firing drive member36is shown as being assembled from the firing bar14attached to a firing connector238by pins240, which in turn is rotatingly and proximally attached to the metal drive rod140. The firing bar14is guided at a distal end of the frame by a slotted guide239inserted therein.

FIGS. 20-23illustrate one embodiment of the wedge sled400of the present invention. As can be seen inFIGS. 20 and 23, the wedge sled400includes a central spacer portion402that extends between the inside sled cams410. A pusher block404is formed on the central spacer portion402for engagement with the middle pin46of the firing bar14. A side profile of one embodiment of an inside sled cam410is depicted inFIG. 21. As can be seen in that FIG., the inside sled cam410has a bottom surface412, and a first camming surface414that forms an angle “G” with the bottom surface412and a second camming surface415that extends to a top surface416. In one embodiment, for example, the angle “G” may be 35 degrees and the angle “G′” may be 20 degrees. The height of the inside sled cam410(the distance between the bottom surface412and the top surface416) is represented as “first” sled cam height “H”. In one embodiment, distance “H′” is approximately 0.173 inches and the length of the top surface416may vary from embodiment to embodiment. As will be further evident as the present Detailed Description proceeds, the first sled cam height represents the vertical distance that the inside sled cams410will drive the corresponding inside drivers330a,330btoward the anvil18during operation.

The wedge sled400further comprises lateral spacer portions406that extend between the inside sled cams410and the outside sled cams420as shown inFIGS. 20 and 23. A side profile of one embodiment of an outside sled cam420is depicted inFIG. 22. In this embodiment, the outside sled cam420has a bottom surface422and a first camming surface424that forms an angle “I” with respect to the bottom surface422and a second camming surface425that to a top surface426. In one embodiment, angle “I” may be approximately 35 degrees and angle “I′” may be approximately 20 degrees. The height of the outside sled cam420(the distance between the bottom surface412and the top surface416) is represented as the “second” sled cam height “J”. In one embodiment, distance “J′” is approximately 0.163 inches. The second sled cam height represents the vertical distance that the outside sled cams420will drive the corresponding outside drivers370a,370btoward the anvil18during operation. The reader will understand that the above-recited dimensions are illustrative of one embodiment and may vary for other embodiments.

With particular reference toFIG. 23, a portion of the staple cartridge300is removed to expose portions of the elongate channel16, such as recesses212,214and to expose some components of the staple cartridge300in their unfired position. In particular, the cartridge body302(shown inFIG. 18) has been removed. The wedge sled400is shown at its proximal, unfired position with a pusher block404contacting the middle pin46(not shown inFIG. 23) of the firing bar14. The wedge sled400is in longitudinal sliding contact upon the cartridge tray224and includes wedges sled cams410,420that force upward the double drivers330a,330band the single drivers370b,370bas the wedge sled400moves distally. Staples222(not shown inFIG. 23) resting upon the drivers330a,330b,370a,370bare thus also forced upward into contact with the anvil forming pockets202in anvil18to form closed staples. Also depicted is the channel slot45in the elongate channel16that is aligned with the elongated slot310in the staple cartridge300.

FIG. 24depicts the end effector12, which is in an open position by a retracted closure sleeve32, with a staple cartridge300installed in the elongate channel16. The firing bar14is at its proximal position, with the upper pin38aligned in a non-interfering fashion with the anvil pocket40. The anvil pocket40is shown as communicating with the longitudinal anvil slot42in the anvil18. The distally presented cutting edge48of the firing bar14is aligned with and proximally from removed from the vertical slot49in the staple cartridge300, thereby allowing removal of a spent cartridge and insertion of an unfired cartridge, which may be “snapfit” into the elongate channel16. Specifically, in this embodiment, extension features316,318of the staple cartridge300engage recesses212,214, respectively (shown inFIG. 23) of the elongate channel16.

FIG. 25depicts the end effector12ofFIG. 23with all of the staple cartridge300removed to show the middle pin46of the firing bar14as well as portion of the elongate channel16removed adjacent to the channel slot45to expose the firing bar cap44. In addition, portions of the shaft23are removed to expose a proximal portion of the firing bar14. Projecting downward from the anvil18near the pivot is a pair of opposing tissue stops244which serve to prevent tissue from being positioned too far up into the end effector12during clamping.FIG. 26depicts the end effector12in a closed position with the firing bar14in an unfired position. The upper pin38is in the anvil pocket40and is vertically aligned with the anvil slot42for distal longitudinal movement of the firing bar14during firing. The middle pin46is positioned to push the wedge sled400distally so that the sled cams410,420contact and lift double drivers330a,330band the single drivers370a,370b, respectively, to drive them upwardly toward the anvil18.

As can be appreciated from reference toFIGS. 14A,15A and19A, in one embodiment of the present invention, the distance between the bottom of the first staple-receiving grooves345,347forming the first staple cradle349and the apex203′ of forming surfaces203of the corresponding forming pocket202of anvil18, when the anvil18is in the closed position and when the inside driver330a,330bis supported on the cartridge tray224, is referred to herein as the first staple forming distance “A”. The distance between the bottom of the secondary staple-receiving grooves345,347forming the secondary staple cradle349and the apex203′ of the forming surface203of the corresponding forming pocket202in the anvil18when the anvil18is in the closed position and the inside driver330a,330bis supported on the cartridge tray224is referred to herein as the secondary staple forming distance “B”. In one embodiment, the first staple forming distance “A” and the secondary staple forming distance “B” are substantially equal to each other. In other embodiments, those distances “A” and “B” may differ from each other.

As illustrated inFIGS. 16A and 19Athe distance between the bottom of the second staple-receiving grooves376,378that form the second staple cradle379and the apex203′ of the forming surface203of a corresponding forming pocket202in anvil18when the anvil18is in the closed position and the outside drivers370a,370bare supported on the cartridge channel224, is referred to herein as a “second” staple forming distance “C”.FIGS. 27 and 28illustrate the forming of staples supported on some of the first outside drivers370a. InFIG. 27, one of the outside sled cams420of the wedge sled400is initially contacting one of the outside drivers370a. As the wedge sled400continues in the driving direction represented by arrow “K” inFIG. 28, the outside sled cam420causes the outside drivers370adrive the staples222supported thereby into the staple forming pockets202in the anvil18. Likewise, as the wedge sled400is driven in the driving direction “K”, the inside sled cams410contact the inside drivers330a,330band causes them to drive the staples222supported thereby into the corresponding staple forming pockets202in the anvil18.

As indicated above, in some applications involving an area of varied tissue composition, it can be desirable to form rows of staples wherein the formed (final) heights of the staples in a row that is the farthest distance away from the cut line are greater than the formed (final) heights of those staples in the row that is closest to the cut line. In other applications, it may be desirable for the formed heights of the staples in a single row to increase (or decrease) from staple to staple. Another clinical benefit would be to have the formed heights of the staples in the outermost rows larger than formed heights of the staples in the inside rows. The various embodiments of the subject invention can provide these results while employing identical staples in all of the rows.

As the present Detailed Description proceeds, those staples222in the outermost rows520,530of staples (those staples formed using the outside staple drivers370a,370b) will be referred to hereinafter as staples222′ and those staples in the innermost rows522,524,526,528of staples (those staples formed using the inside staple drivers330a,330b) will be referred to hereinafter as staples222″. It will be understood, however, that staples222′ and222″ are identical to each other prior to being formed by the various embodiments of the present invention. That is, staples222′ and222″ each have identical prong lengths “P” and widths “W”. Returning toFIGS. 14A-16Aand21and22, the above desired effects may be attained by altering the staple forming distances “A”, “B”, and “C” relative to each other and/or the sled cam heights “H” and “J”. In one embodiment of the subject invention, for example, the height “H” of each of the inside sled cams410is substantially equal to the sled height “J” of each of the outside sled cams420. SeeFIGS. 21 and 22. In this embodiment, the staple forming distances “A” and “B” are substantially equal to each other, but distances “A” and “B” are less than the staple forming distance “C”. The distance “D” between the bottoms of the first staple-receiving grooves345,347and the bottom surface342′ of the primary driver base342is substantially equal to the distance “E” between the bottoms of the secondary staple-receiving grooves356,357and the bottom surface352′ of the secondary driver base portion352. SeeFIG. 15. Also in this embodiment, the distance “F” between the bottoms of the second staple-receiving grooves376and378and the bottom surface373of the third base372of the outside drivers370a,370b(FIG. 16) is less than distances “D” and “E”(FIG. 15). Because the forming distance “C” is greater than the forming distances “A” and “B”, the staples222supported and formed by the outside drivers370a,370bare not compressed as much as the staples supported and formed by the inside drivers330a,330b. It will be understood that similar results may be attained on the opposite side of the elongated slot310and the cut line600formed in the tissue by using the same arrangements and sizes of inside drivers330band outside drivers370b. In an alternative embodiment, the same effect may be achieved by altering the depths of the forming pockets202corresponding to the drivers330aand370bsuch that forming distance “C” is greater than the forming distances “A” and “B”. That is, the depth (distance “Z′” inFIG. 16A) of the those forming pockets202corresponding to the outside drivers370a.370bmay be greater than the depth (distance “Z” inFIG. 14A) of the forming pockets202that correspond to the inside drivers330a,330b.

FIG. 29illustrates the rows of staples formed on each side of a cut line600utilizing this embodiment of the present invention wherein the forming distances “A” and “B” are equal to each other and the forming distance “C” is greater than the forming distances “A” and “B”. For example, if forming distance “C” is 0.020″ greater than forming distances “A” and “B”, the formed height of the outside staples222′ (represented as dimension “L” inFIG. 30) in rows520and530would be 0.020 inches is greater than the formed height of the inside staples222″ (represented as dimension “M” inFIG. 31) in rows522,524,526,528.

The same result may be achieved by utilizing another embodiment of the present invention wherein the forming distances “A”, “B” and “C” are essentially equal. In this embodiment, however, the height of each of the inside sled cams410(distance “H” inFIG. 21) is greater than the height of each of the outside sled cams420(distance “J” inFIG. 22). Thus, because the height “H” of the inside sled cams410is greater than the height “J′” of the outside sled cams420, the inside sled cams410will drive the corresponding inside drivers330a,330bfurther towards the anvil than the outside sled cams420will drive the corresponding outside drivers370a,370b. Such driving action will cause the staples supported by the inside drivers330a,330bto be compressed to a greater extent than those staples supported by the outside drivers370a,370b. For example, if distance “H” is 0.020 inches greater than distance “J”, the formed height of staples222′ in lines520,530would be 0.020″ greater than the formed height of staples222″ in lines522,524,526,528.

When employing yet another embodiment of the present invention, the outside rows520,530of staples222′ and the inside rows522,528of staples222″ may be formed with heights that are greater than the formed heights of the staples222″ in the inside rows524,526. SeeFIG. 32. This result is achieved by making the forming distances “C” greater than the forming distance “A” and making forming distance “A” greater than secondary forming distance

Another embodiment of the present invention can be used to install staples where it is desirable for the formed heights of staples in a single row to vary. One such arrangement is depicted inFIG. 33. As can be seen inFIG. 33, the formed heights of the staples222′ in the outside rows520,530increase when moving from the proximal ends521,531of each row520,530, respectively to the distal ends523,533of each row520,530, respectively. This effect may be accomplished by decreasing the forming distance “C” for each succeeding driver370a,370b. That is, the driver370aclosest the proximal end of the cartridge300would be sized to establish a forming distance “C” that is greater than the forming distance “C” achieved by the adjacent driver370aand so on to achieve a condition wherein each succeeding staple222′ (moving in the direction from the proximal end to the distal end of the cartridge300) would have larger formed heights. This result could also be attained in the staples222″ in rows522,524,526,528by similarly altering the forming distances “A” and/or “B” attained by each driver330a,330b. Likewise, formed heights of the staples222′ in the outside rows520,530could be made to decrease when moving from the proximal ends521,531of each row520,530, respectively, to the distal ends523,533of each row520,530, respectively. This result may be attained by increasing the forming distance of each succeeding driver370a,370b. That is, the driver370aclosest the proximal end of the cartridge300would have a forming distance “C” that is less than the forming distance “C” of the adjacent driver370aand so on to achieve a condition wherein each succeeding staple222′ (moving in the direction from the proximal end to the distal end of the cartridge) would have smaller formed heights. SeeFIG. 34.

In use, the surgical stapling and severing instrument10is used as depicted inFIGS. 1-2and35-41. InFIGS. 1-2, the instrument10is in its start position, having had an unfired, fully loaded staple cartridge300snap-fitted into the distal end of the elongate channel16. Both triggers26,28are forward and the end effector12is open, such as would be typical after inserting the end effector12through a trocar or other opening into a body cavity. The instrument10is then manipulated by the clinician such that tissue248to be stapled and severed is positioned between the staple cartridge300and the anvil18, as depicted inFIG. 35. With reference toFIGS. 36 and 37, the clinician then moves the closure trigger26proximally until positioned directly adjacent to the pistol grip24, locking the handle portion20into the closed and clamped position. The retracted firing bar14in the end effector12does not impede the selective opening and closing of the end effector12, but rather resides within the anvil pocket40. With the anvil18closed and clamped, the E-beam firing bar14is aligned for firing through the end effector12. In particular, the upper pin38is aligned with the anvil slot42and the elongate channel16is affirmatively engaged about the channel slot45by the middle pin46and the firing bar cap44.

With reference toFIGS. 38 and 39, after tissue clamping has occurred, the clinician moves the firing trigger28proximally causing the firing bar14to move distally into the end effector12. In particular, the middle pin46enters the staple cartridge300through the firing drive slot47to effect the firing of the staples222(not shown inFIGS. 38 and 39) via wedge sled400toward the anvil18. The lowermost pin, or firing bar cap44, cooperates with the middle pin46to slidingly position cutting edge48of the firing bar14to sever tissue. The two pins44,46also position the upper pin38of the firing bar14within longitudinal anvil slot42of the anvil18, affirmatively maintaining the spacing between the anvil18and the elongate channel16throughout its distal firing movement.

With reference toFIGS. 40 and 41, the clinician continues moving the firing trigger28until brought proximal to the closure trigger26and pistol grip24. Thereby, all of the ends of the staples222are bent over as a result of their engagement with the anvil18. The firing bar cap44is arrested against a firing bar stop250projecting toward the distal end of the channel slot45. The cutting edge48has traversed completely through the tissue. The process is complete by releasing the firing trigger28and by then depressing the release button30while simultaneously squeezing the closure trigger26to open the end effector12.

In various embodiments, as outlined above, a staple cartridge can include a first row of staples which can be deformed to a first height and, in addition, a second row of staples which can be deformed to a second height, wherein the first height can be shorter than the second height. As a result, the staples within the first row can apply a larger clamping force to soft tissue captured therein as compared to the clamping force applied by the staples within the second row. Such embodiments can be utilized to apply a larger clamping force along the perimeter of incised tissue, for example, in order to reduce bleeding therefrom while providing a smaller clamping force to the tissue in an adjacent row, or rows, of staples. In various embodiments, such adjacent rows of staples can provide additional support to the soft tissue without unnecessarily stiffening the soft tissue or constricting the flow of blood therein.

In at least one embodiment, referring toFIG. 48, each of the staples within a first, or inner, staple row can be deformed to a height within a first height range and each of the staples within a second, or middle, staple row can be deformed to a height within a second height range, wherein the first height range can be different than the second height range. In various embodiments, the first height range and the second height range can be mutually exclusive or, in at least one embodiment, there can be some overlap between the two ranges. In at least one embodiment, the staples within the first row can be deformed to a first average height and the staples within the second row can be deformed to a second average height, wherein the first average height can be different than the second average height. Similar to the above, each of the staples within a third row of staples can be deformed to a height within a third height range which is different than the first height range and the second height range in order to apply different clamping forces to the soft tissue.

Oftentimes, further to the above, a larger clamping force can generate a larger clamping pressure within the soft tissue captured by a staple. More particularly, in at least one embodiment, a clamping force can be proportional to the product of the pressure that it applies and the area across which it is applied. As a result, a staple which is deformed to a shorter staple height can create a larger clamping pressure within the soft tissue as compared to a staple which is deformed to a larger staple height, assuming that the area across which the clamping forces are applied is the same. In view of the above, a surgical staple can include tissue-contacting areas configured to increase and/or decrease the clamping pressure applied by a given clamping force.

In various embodiments, referring toFIG. 42, a staple622can include crown624and deformable members, or legs,630and634which can extend from crown624. In at least one embodiment, crown624can include tissue-contacting surfaces625which can be configured to support soft tissue, for example, thereon when deformable members630and634are deformed to capture the soft tissue within staple622. As compared to portion223of staple222(FIG. 12), surfaces625can provide a larger surface area to support soft tissue and, as a result, reduce the pressure applied to the soft tissue by the deformed staple legs. Further to the above, in various embodiments, crowns624and/or tissue-contacting surfaces625, for example, can define a width which is wider than the width of the deformable members. Referring toFIG. 48, for example, crowns624, and/or tissue-contacting surfaces thereon, can be defined by a width “W2” which is wider than a width “W1” defined by the cross-section of deformable members630, for example. In various embodiments, the width of crowns624and/or surfaces625can be selected such that a desired clamping pressure is applied to the tissue captured within the staples. For example, a crown624or surface625can be selected such that it is only slightly wider than one of the deformable members wherein, in such embodiments, less surface area is available to support the tissue which can increase the clamping pressure within the tissue as compared to the surface area provided by the crowns624or surfaces625illustrated inFIGS. 46 and 47which are much wider than the deformable members. In at least one embodiment, although not illustrated, the staples within a first row can include crowns having a first width and the staples within a second row can include crowns having a different, or second, width such that the first row of staples can apply a first clamping pressure to the soft tissue while the second row of staples can apply a different, or second, clamping pressure.

In various embodiments, deformable members630and634of staple622, for example, can be comprised of separate deformable wires or, alternatively, deformable members630and634can comprise a single contiguous wire extending through at least a portion of crown624. In at least one embodiment, the deformable members can be comprised of one or more metals, or any other suitable deformable material, such as titanium, for example. In any event, crown624can be overmolded onto, or otherwise suitably attached to, at least a portion of deformable members630and634in order to form tissue-contacting surfaces625. In various embodiments, referring toFIG. 43, a staple cartridge can include an inner row of staples622which can be deformed to a first height (represented by dimension “M”), a middle row of staples622which can be deformed to a second height (represented by dimension “M′”), and an outer row of staples622which can be deformed to a third height (represented by dimension “L”). Similar to the above, a staple cartridge can include various staple drivers, for example, for driving staples622against an anvil, for example, to deform the staples to such various heights.

In various embodiments, referring toFIG. 47, a staple cartridge600can include staple drivers670aand670b, for example, which can be configured to deploy staples622from staple cartridge600. In at least one embodiment, similar to the above, staple driver670bcan include a first, or inner, cradle626for supporting a first, or inner, staple622a distance “A” from datum603, a second, or middle, cradle627for supporting a second, or middle, staple622a distance “B” from datum603, and a third, or outer, cradle628for supporting a third, or outer, staple622a distance “C”. Datum603can represent a forming surface of an anvil against which the staples can be deformed although, in various embodiments, an anvil can include various forming surfaces which may not lie along a single datum. In any event, referring toFIG. 48, the inner staple622can be deformed to a staple height represented by dimension M, the middle staple622can be deformed to a staple height represented by dimension M′, and the outer staple622can be deformed to a staple height represented by dimension L. In such embodiments, the inner staple622can be part of a first row of staples which apply a first, or larger, clamping force to tissue “T”, the middle staple622can be part of a second row of staples which apply a second, or intermediate, clamping force to tissue T, and the outer staple622can be part of a third row of staples which apply a third, or smaller, clamping force to tissue T.

In various other embodiments, referring toFIG. 46, a staple cartridge600′ can include staple drivers670a′ and670b′ which can, similar to the above, be configured to deploy staples622from staple cartridge600. In at least one embodiment, staple driver670b′ can include a first, or inner, cradle626′ for supporting a first, or inner, staple622a distance A′ from datum603, a second, or middle, cradle627′ for supporting a second, or middle, staple622a distance B′ from datum603, and a third, or outer, cradle628′ for supporting a third, or outer, staple622a distance C′ from datum603, where C′ can be shorter than B′, and where B′ can be shorter than A′. In at least one such embodiment, the outer staple622can be deformed to a staple height which is shorter than the staple height to which the inner and middle staples are deformed.

In various embodiments, as illustrated inFIGS. 46 and 47, staples622can have the same, or at least substantially the same, undeformed height “P”. In other various embodiments, as illustrated inFIGS. 44 and 45, a staple cartridge can include staples having different undeformed staple heights. In at least one embodiment, referring toFIG. 44, staple cartridge600″, for example, can include inner staple622asupported a distance A″ away from datum603, middle staple622bsupported a distance B″ away from datum603, and outer staple622csupported a distance C″ away from datum603, where inner staple622acan be taller than staples622band622cwhen measured in their undeformed configurations. In various embodiments, the undeformed heights of the staples and the distances in which the staples are displaced can be calculated to provide a suitable arrangement of deformed staple heights within the targeted soft tissue. Similar to the above, in at least one embodiment and referring toFIG. 45, staple cartridge600′″, for example, can include inner staple622dsupported a distance A′″ away from datum603, middle staple622esupported a distance B′″ away from datum603, and outer staple622fsupported a distance C′″ away from datum603, where inner staple622dcan be shorter than staples622eand622f, and where middle staple622ecan be shorter than staple622fwhen measured in their undeformed configurations.

As outlined above, a staple can be configured to apply a clamping force and pressure to soft tissue captured therein. In various circumstances, it may be desirable to maintain such a clamping force and pressure for a prolonged period of time. In other circumstances, it may be desirable for the clamping force and/or pressure to increase and/or decrease during the healing process. In various embodiments, various portions of a staple, such as the crown and/or deformable members, for example, can be coated in a material which can expand and increase the clamping force and/or pressure to the soft tissue after the staple has been deployed into the tissue. In at least one embodiment, various portions of a staple can be comprised of a dissolvable, bioabsorbable, or biofragmentable material which, as the material breaks down, can slowly relieve the clamping force and/or pressure applied to the soft tissue. Such embodiments are described in greater detail below.

In various embodiments, referring toFIG. 49, a surgical staple722can include a first deformable member730including first leg731and second leg732and, in addition, a second deformable member734including first leg735and second leg736. In at least one embodiment, staple722can further include dissolvable crown724which can be configured to hold deformable members730and734relative to each other and, after crown724has been dissolved, permit deformable members730and734to move relative to each other. Similar to the above, referring toFIGS. 50 and 51, a surgical staple722′ can include a first deformable member730′, a second deformable member734′, and a crown724′ which can connect the deformable members before it is dissolved. In various embodiments, each deformable member can include a base723′ which can connect the first and second legs of the deformable member where, in at least one embodiment, the bases723′ of the deformable members can be embedded in a material which is overmolded thereon. In various embodiments, as outlined above, the material can include a dissolvable, bioabsorbable, or biofragmentable material such as Vicryl and/or PDS from Ethicon, Inc., for example. As used herein, the terms dissolvable, bioabsorbable, and biofragmentable all generally refer to materials that can be at least partially assimilated by the body after being implanted into a patient, for example.

In use, staple722′, for example, can be inserted into soft tissue via a stapler and can be deformed into the configuration illustrated inFIG. 52. More particularly, in at least the illustrated embodiment, deformable members730′ and734′ can be deformed by the anvil of the stapler such that ends733′ of legs731′ and735′ are brought into close proximity to crown724′, for example. Once staple722′ is implanted into the tissue, crown724′ may begin to break down, dissolve, and weaken. More particularly, referring toFIG. 53, the bioabsorbable material of crown724′ may deteriorate to the point where first member730′ and second deformable member734′ become disconnected from each other. Once first member730′ and second member734′ have become disconnected, they can move relative to one another as illustrated inFIG. 54. The time required for crown724′ to sufficiently dissolve may depend on the material used and/or the size of crown724′. Polyglatin910material, sold under the tradename Vicryl, for example, may dissolve in 7-14 days.

In various embodiments, a dissolvable crown may provide several therapeutic advantages. For example, when staple722′ is initially deployed, deformable members730′ and734′ may significantly compress the tissue within the staple against crown724′. In some applications, this compression may be desirable to limit bleeding from the tissue. As crown724′ deteriorates, the gap between the deformed members730′ and734′ and crown724′ may increase thereby relaxing the compressive forces acting on the tissue. In some applications, relaxing the compression forces during the healing process may allow the tissue to slowly expand and return to its normal thickness over a period of time. In some embodiments, crown724′ can be coated with a hydrophilic material that initially expands to compress the tissue captured within the staple before dissolving away thereafter. In these embodiments, the hydrophilic material can expand by absorbing water from the surrounding tissue and fluids. In addition to the above, staple722′, when it is inserted into the tissue, may be very stiff and, if several staples are inserted into the tissue, the tissue may not be permitted to move and expand during the healing process. However, after crowns724′ of staples722′ have dissolved, the deformable members of the staples may be able to move relative to each other while still holding the underlying tissue together.

In various embodiments, the deformable members of a staple may be comprised of a substantially non-dissolvable or non-bioabsorbable material. In other embodiments, at least one of the deformable members may be comprised of a dissolvable, bioabsorbable, or biofragmentable material such as magnesium or iron, for example. In at least one embodiment, the iron is pure iron. In either event, the dissolvable material of the deformable members730′ and734′, for example, can be selected such that they dissolve at the same rate as, slower than, or faster than the dissolvable material of crown724′, for example. In at least one example, the material of crown724′ can be selected such that it completely dissolves away while deformable members730′ and734′ are still holding tissue together. In other various embodiments, the material of first deformable member730′ can be selected such that it dissolves faster than the material of second deformable member734′. Accordingly, the deformable members of these embodiments may allow for a staggered release of the tissue. In other various embodiments, at least two adjacent staples can be connected by a bridge before and/or after the staples have been deployed into the tissue. In these embodiments, the bridge connecting the staples can be comprised of materials that dissolve away at the same rate, and/or a different rate, than the first and second staples. In these embodiments, the bridges can dissolve away before the first staples and/or the second staples allowing for a staggered release of the tissue.

In various embodiments, the staples described above can be used to approximate tissue, i.e., the staples can secure resected or damaged tissue such that the strength of the resected or damaged tissue approximates that of healthy tissue. To this end, a method of approximating tissue can include suturing tissue with a surgical staple comprised of a dissolvable material and a non-dissolvable material to approximate tissue in a first state, and dissolving the dissolvable material to cause the remaining non-dissolvable material to approximate the tissue in a second state. In at least one embodiment, the tissue approximation in the second state is more flexible than in the first state.

In addition to the above, a crown may be comprised of at least two overmolded or co-molded materials. More particularly, referring toFIG. 55, crown724″ of staple722″ may be comprised of a first material740″ overmolded onto at least a portion of deformable members730″ and734″ and a second material742″ overmolded onto first material740″, for example. In such an embodiment, second material742″ can be configured to dissolve away quickly thereby allowing deformable members730″ and734″ to separate from each other early on in the healing process. However, in at least one embodiment, first material740″ can be selected to dissolve at a slower rate than second material742″ in order for crown724″ to continue to provide a compressive force on the tissue even after second material742″ has completely dissolved away. In at least one embodiment, first material740″ can be injection molded onto deformable members730″ and734″ and then permitted to cure, and/or substantially solidify, before second material742″ is injection molded onto first material740″. In other various embodiments, first material740″ and second material742″ can be injection molded onto deformable members730″ and734″ at substantially the same time or in rapid succession. In these embodiments, the first and second materials can chemically bond together to provide sufficient strength therebetween so that the staple may be handled without the first and second materials separating from one another. In other embodiments, the first and second materials can form mechanically interlocking features to accomplish the same result.

In at least one embodiment, referring to the embodiment illustrated inFIG. 51, crown724′ may include reduced cross-section737′ intermediate portions738′ and739′. In use, intermediate section737′, as it has a smaller cross-section than portions738′ and739′, may completely dissolve away before sections738′ and739′ thereby allowing first member730′ to become unconnected from second member734′ before the entirety of crown724′ has dissolved. In at least one embodiment, the cross-sections of sections737′,738′, and739′can be selected such that deformable members730′ and734′ can become unconnected at a desired stage in the healing process. In at least one embodiment, referring toFIG. 56A, crown734′″ of staple722′″ can include score marks743′″ which reduce the thickness of crown724′″ in the scored areas. In these embodiments, the score marks may be formed when crowns724′″ are overmolded onto deformable members730′″ and734′″ or formed by a cutting tool thereafter. As a result of score marks743′″, crown724′″, as it dissolves, can break up into several small pieces which are, in some circumstances, more easily absorbable by the body. In at least one embodiment, referring toFIG. 56B, crown724″″ may include a plurality of pockets744″″ intermediate raised portions745″″. In use, the material intermediate raised portions745″″ may dissolve away leaving behind a lattice, or grid, of raised portions745″″ intermediate deformable members730″″ and734″″.

In at least one embodiment, a crown of a surgical staple can also comprised of at least one therapeutic drug. In these embodiments, as the dissolvable material deteriorates, the therapeutic drug can be absorbed by the surrounding tissue. In some embodiments, the drug is dispersed throughout the dissolvable material such that the drug is steadily released during the healing process. In other embodiments, however, the therapeutic drug may be unevenly dispersed throughout the dissolvable material, or layered within and/or on the material, to provide an increased dosage of the drug at a particular stage in the healing process.

In various embodiments, a crown overmolded or assembled onto various portions of a staple may act as an electrical insulator. In at least one embodiment, a staple having such a crown or insulator may reduce the possibility of arcing along a row of staples when an electrocautery device is used in situ, for example. In effect, the absorbable insulators, or crowns, on the staples can substantially prevent an electrical current from jumping between staples as the top of each staple may not be electrically conductive under normal operating conditions. As a result, the possibility of damaging tissue may be reduced.

In various circumstances, when one or more of the deformable members of a staple are inserted through soft tissue, for example, the deformable members can puncture the soft tissue creating holes therein. As a result, eventhough the deformable members can substantially fill the puncture holes, blood may flow, at least initially, from the soft tissue surrounding the puncture holes. In various embodiments of the present invention, as indicated above, at least a portion of the deformable members can expand and apply a compressive force against the soft tissue in order to stop, or at least reduce, bleeding from the soft tissue surrounding the puncture holes. In at least one embodiment, referring toFIGS. 81-87, at least a portion of first and second deformable members1130and1134can be coated with expandable coating1199. In various embodiments, referring toFIG. 82, expandable coating1199can have a first diameter when it is initially inserted into the soft tissue and can apply, depending upon the size of the deformable members and the puncture holes, a first compressive force to the soft tissue surrounding the deformable members. Thereafter, referring toFIG. 86, expandable coating1199can increase in size to apply a larger, or second, compressive force to the soft tissue surrounding the deformable members. In various embodiments, this second compressive force may be sufficient to close, or at least constrict, the blood vessels in the soft tissue surrounding the puncture hole to eliminate, or at least reduce, the flow of blood therethrough.

In various embodiments, expandable coating1199can be comprised of a hydrophilic material, or any other suitable material which has an affinity for water, that can absorb blood, or other fluids in the surgical site, in order to expand as described above. In at least one embodiment, a fluid can be introduced into the surgical site which can cause expandable coating1199to expand. In various embodiments, expandable coating1199can be comprised of a cross-linked ester compound having a polyethylene glycol base polymer, for example. In at least one such embodiment, expandable coating1199can be overmolded onto at least a portion of staple1122using an injection molding process. In various embodiments, the deformable members and/or crown, such as crown1124, for example, can be entirely, or at least partially, comprised of an expandable material. In at least one such embodiment, the deformable members and/or crown can expand to compress the tissue captured within the deformable members after they have been deformed. In either event, after expandable material1199has expanded, at least a portion thereof can begin to dissolve and can be absorbed by the patient's body. In such embodiments, the second compressive force applied to the soft tissue can be relaxed and the soft tissue can be permitted to expand and grow in order to fill the puncture holes, for example. Such embodiments can be particularly useful when the deformable members and/or crown are also comprised of dissolvable or bioabsorbable materials as described above. In various embodiments, the expandable coating can also comprise a therapeutic agent, for example, which can be released as expandable coating1199is dissolved, for example. Further embodiments are disclosed in U.S. patent application Ser. No. 11/824,446, entitled SURGICAL STAPLE HAVING AN EXPANDABLE PORTION, which was filed on Jun. 29, 2007, the entire disclosure of which is hereby incorporated by reference herein.

In various embodiments, referring toFIGS. 88-91, surgical staple1222can include crown1224, first deformable member1230, and second deformable member1234where deformable members1230and1234can extend from crown1224. In at least one embodiment, at least a portion of first deformable member1230and/or second deformable member1234can have a non-circular cross-section. More particularly, referring toFIG. 88, the cross-section of deformable member1234, for example, can include arcuate portion1295and flat portion1297. In various embodiments, deformable members1230and/or1234can comprise a wire having a cross-section which is substantially constant throughout the length of the wire or, in other embodiments, a wire having more than one cross-section. In at lest one embodiment, although not illustrated, a first deformable member and a second deformable member can have different cross-sections. In at least one such embodiment, the first deformable member can include a substantially circular cross-section, for example, and the second deformable member can include a non-circular cross-section, for example. In other various embodiments, the first deformable member can include a non-circular cross-section which is different than a non-circular cross-section of the second deformable member.

In various embodiments, the cross-sectional geometry of deformable members1230and1234, for example, can control the manner and direction in which deformable members1230and1234are bent when they are deformed by an anvil as described above. In at least one embodiment, flat portions1297can be oriented such that they are facing each other and, as a result, flat portions1297can cause deformable members1230and1234to bend toward each other when a force is applied thereto. In other various embodiments, flat portions1297, for example, can be oriented in any suitable manner to allow the deformable members to bend in a desired direction. In effect, the size and location of flat portion1297can affect the moment of inertia of the cross-section of the deformable members and, correspondingly, affect the manner in which the deformable members respond to the bending stress applied thereto. In at least one embodiment, the deformation of the deformable members can be controlled in order to apply a desired compressive force to the soft tissue captured within the staple. More particularly, in at least one embodiment, deformable members1230and1234can be bent until they contact the soft tissue and apply a compressive force to the soft tissue where the amount of force applied is largely determined by the amount and direction in which deformable members1230and1234are deformed and, in addition, the geometry of the portion of the deformable members which is in contact with the soft tissue. For example, a flat portion of a deformable member can be configured to apply a lower clamping pressure to soft tissue than a round portion as a flat portion may provide more contact area across which the clamping force can be applied. In further various embodiments, the cross-sections of deformable members can include any suitable combination of flat, arcuate, and/or radiused surfaces including those disclosed in U.S. patent application Ser. No. 11/824,299, entitled SURGICAL STAPLE HAVING A DEFORMABLE MEMBER WITH A NON-CIRCULAR CROSS-SECTIONAL GEOMETRY, which was filed on Jun. 29, 2007, the entire disclosure of which is hereby incorporated by reference herein.

In various embodiments, referrring toFIGS. 57-65, staple822can include base823, first deformable member830, and second deformable member834where, in at least one embodiment, staple822can further include crown824having apertures846defined therein which can be configured to receive the first and second deformable members. As described in further detail below, deformable members830and834can be configured to move, or slide, within apertures846such that base823can be moved relative to crown824. In at least one such embodiment, each aperture846can define an axis847extending therethrough where the deformable members can be configured to move along axes847when they are moved within apertures846. In various embodiments, crown824, referring toFIG. 60, can include recess848which can be configured to receive base823and at least limit, if not prevent, relative movement between base823and crown824. In at least one embodiment, base823can be movably positioned within recess848such that recess848can permit deformable members830and834to move along axes847but at least inhibit base823from moving transversely to axes847. In various embodiments, recess848can be configured to receive base823in a press-fit and/or snap-fit configuration such that, once base823is positioned in recess848, base823can be substantially immovable relative to crown824.

In various embodiments, referring toFIGS. 66-69, staples822can be removably stored within a staple cartridge, such as staple cartridge800, for example. In at least one embodiment, staple cartridge800can include body801having cavities802defined therein. Staple cartridge body801can further include deck803having top surface804where cavities802can include an opening in top surface804. In various embodiments, each cavity802can be configured to receive at least a portion of a staple822where deck823can include recesses805which can be configured to removably receive crowns824. In use, referring toFIG. 66, base823can be situated in a first position in cavity802before it is moved toward crown824. In at least one embodiment, deformable members830and834can include ends819where, in this first position, ends819can be positioned within or proximal to apertures846. In such embodiments, as a result, when deformable members830and834are moved relative to crown824as described above, deformable members830and834can be pre-aligned with axes847and the possibility of deformable members830and834becoming misaligned with apertures846can be reduced.

In various embodiments, referring toFIGS. 67 and 68, deformable members830and834and base823of staple822can be moved, or slid, relative to crown824by driver850. In at least one embodiment, as outlined above, staple cartridge800can further include a wedge sled configured to lift driver850and move base823toward crown824. Although the wedge sled is not illustrated inFIGS. 67 and 68, exemplary sleds are described and illustrated in the present application and can include wedge sled400inFIG. 20, for example. In various embodiments, referring toFIG. 67, driver850can push or slide base823upwardly until base823contacts crown824and engages recess848as described above. Thereafter, referring toFIGS. 68 and 69, base823and crown824can be forced upwardly by driver850such that crown824is removed from recess805. In various embodiments, crown824, for example, can be press-fit or snap-fit within recesses805such that driver850must apply a sufficient force to dislodge crown824from recess805. In other various embodiments, as described in greater detail below, crown824, for example, can be integrally molded with deck803such that driver850must apply a sufficient force to base823to break crown824away from staple cartridge body801.

In various embodiments, driver850, for example, can be configured to drive deformable members830and834against an anvil such that the deformable members are deformed by the anvil, as described above. As a result, also similar to the above, the deformable members can capture the soft tissue and compress it against crown824. In various embodiments, crown824may further include tissue-contacting surface825which can be used to control the compressive pressure applied to the soft tissue as outlined above. By way of example, when surface825includes a large area against which the soft tissue is compressed, the compressive pressure applied to the soft tissue can be much less than when surface825includes a smaller area. In at least one embodiment, tissue-contacting surface825can have a first width and base823can have a second width. In at least one such embodiment, the first width of tissue-contacting surface825can be wider than the second width of base823such that tissue-contacting surface825comes into contact with tissue and not base823.

In various embodiments, tissue can be captured and compressed between staple cartridge800and the anvil before staples822are deployed into the soft tissue. In at least one embodiment, crowns824can be positioned within recesses805of staple cartridge body801such that surfaces825of crowns824can be aligned, or substantially flush, with top surface804of deck803. In at least one such embodiment, as a result, the compressive force, or pressure, applied to the soft tissue by deck803and crowns824can be substantially the same. In other various embodiments, crowns824can be positioned within recesses805such that surfaces825are positioned above top surface804of staple deck803. In such embodiments, the compressive force, or pressure, applied to the soft tissue by crowns825can be larger than the compressive force, or pressure, applied by deck803. In various embodiments, the relative distance between surfaces825and top surface804can be selected to provide a desired pre-deployment compression force, or pressure, to the soft tissue. In other various embodiments, surfaces825can be positioned below top surface804of deck803such that the compression force, or pressure, applied to the soft tissue by surfaces825is less than the compressive force, or pressure, applied by deck803.

In various embodiments, referring toFIGS. 58,61, and64, staple822′ can include deformable members830′ and834′ which may be configured to pierce crown824′ in lieu of passing through apertures as described above with respect to staple822. In such embodiments, ends819′ of the deformable members can be sharp enough to puncture crown824′ and create holes therein which can allow deformable members830′ and834′ to move, or slide, relative thereto. In other various embodiments, referring toFIGS. 59,62, and65, staple822″ can include deformable members830″ and834″ which can be positioned outside the perimeter of crown824″. In at least one such embodiment, although not illustrated, crown824″ can include recesses, or slots, which can be configured to slidably receive deformable members830″ and834″. In any event, referring toFIGS. 70-73, a staple, such as staple822′″, for example, can include a slidable crown, such as slidable crown824′″, which can be slid relative to deformable members830′″ and834′″ before, during, and/or after the deformable members are deformed by an anvil. In at least one embodiment, a staple822′″, or any other suitable staple described herein, can be deformed to a staple height designated by distance “L”, for example, or a shorter staple height designated by distance “M” in order to achieve the advantages discussed herein.

As outlined above, a portion of a staple cartridge can be broken away from the body of the staple cartridge as a staple is deployed therefrom. In various embodiments, this portion can be configured to be positioned intermediate the base of the staple and soft tissue captured within the staple. In at least one embodiment, referring toFIGS. 74-76, a surgical stapling system can include staple cartridge900having staple pads924integrally molded into deck903of staple cartridge900. Further to the above, staple cartridge900can include one or more score marks951and slots952surrounding staple pads924such that staple pads924can be easily separated from deck903. In at least one embodiment, referring toFIG. 76, the stapling system can include drivers950having shears953which can be configured to press against staple pads924when bases923of staples922are brought in close proximity to staple saddles948of pads924and “punch-out” staple pads924from deck903. In at least one embodiment, after staple pads924have been punched out from deck903, the staple pads can be positioned intermediate bases923and the tissue captured within staples922. As a result, staple pads924can be configured to act as the crown of the staple or, in alternative embodiments, act as a buttressing member intermediate the staple and the tissue. In at least one embodiment, similar to the above, staple pads924can be comprised of a bioabsorbable material.

Similar to staple cartridges600and800, for example, staple cartridge900can be configured to deploy staples922such that they can be deformed to various staple heights utilizing various staple drivers and/or various staple leg lengths to provide a desired clamping force and/or pressure as described above. In various embodiments, referring toFIGS. 77-79, other means can be utilized to provide a desired clamping force and/or pressure to soft tissue including, in at least one embodiment, a staple cartridge having one or more rows of staples stored therein which have different crown heights. More particularly, in at least one embodiment, a staple cartridge can include a first row of first staples1022which have a crown height of Y, a second row of staples1022′ which have a crown height of Y1, and a third row of staples1022″ which have a crown height of Y2. Owing to the different crown heights of the staples, the third staples1022″, for example, can be configured to apply a larger clamping force to soft tissue captured therein as compared to staples1022and1022′, assuming that deformable members1030and1034of the staples are deformed the same amount. Similarly, second staples1022′ can be configured to apply a larger clamping force than first staples1022.

In various embodiments, further to the above, the distance between tissue-contacting surfaces1025of crown1024and tips1019of the deformable members of first staples1022, i.e., distance X, can be larger than the distances between the tissue-contacting surfaces1025and deformable member tips1019of staples1022′ and1022″, i.e., distances X1and X2, respectively. In such embodiments, when deformable members1030and1034of each of the staples are deformed the same distance, staple1022can define a larger area, or volume, for the soft tissue to reside therein as compared to staples1022′ and1022″. Owing to the larger area, or volume, defined by staple1022, deformable members1030and1034may apply a lesser clamping force to the soft tissue as compared to staples1022′ and1022″ and, as a result, such staples can be selectively utilized to provide a desired therapeutic effect. In at least one such embodiment, each staple1022,1022′, and1022″ can have the same overall undeformed stapled height represented by distance “Z”, where the sum of the distances of X and Y, X1and Y1, and X2and Y2can respectively equal, or at least substantially equal, Z. To achieve the above, crowns1024,1024′, and1024″ can be overmolded onto at least portions of the deformable members of staples1022,1022′, and1022″, respectively, such the position of tissue-contacting surfaces1025with respect to tips1019can be controlled through an injection molding process.

In various embodiments, further to the above, a staple cartridge can include, among other things, a first row of first staples1022, a second row of staples1022′, and a wedge sled for deploying staples1022and1022′ from the staple cartridge, for example. In at least one embodiment, the staple cartridge can further include at least one staple driver which can be configured to cooperate with the wedge sled to deploy the staples. Similar to the above, in various embodiments, each staple driver can include a first cradle for supporting a first staple1022and a second cradle for supporting a second staple1022′ wherein the first and second cradles can be positioned relative to an anvil forming surface such that they can define the same, or nearly the same, distance therebetween. In such embodiments, owing to the different crown heights of staples1022and1022′ as outlined above, staples1022can apply a different clamping force than staples1022′ eventhough they are driven the same, or at least substantially the same, staple-deforming distance by the staple drivers. Stated another way, the tissue-contacting surfaces1025of staples1022′ can be positioned closer to the staple forming surface than the tissue-contacting surfaces1025of staples1022eventhough the bottom surfaces1055of staples1022and1022′ are supported at substantially the same distance relative to the staple-forming surface.

In various alternative embodiments, further to the above, the staple drivers for deploying the various staples described herein can be integrally-formed with the crowns of the staples, for example. In at least one embodiment, such integrally-formed drivers can simplify the assembly of the staple cartridge and, in various circumstances, reduce the possibility of misalignment between the staple drivers and the staples. In various embodiments, the integrally-formed drivers can be at least partially comprised of a bio-absorbable material, for example, such that, when the staple drivers are deployed with the staples into the patient, the staple drivers can dissolve during the healing process.

As described above and illustrated herein, rows of staples can be arranged in a linear, or at least substantially linear, arrangement, and can be deployed by various surgical staplers including those disclosed in U.S. Pat. No. 5,697,543, entitled LINEAR STAPLER WITH IMPROVED FIRING STROKE, which issued on Dec. 16, 1997; U.S. Pat. No. 6,131,789, entitled SURGICAL STAPLER, which issued on Oct. 17, 2000; and U.S. Pat. No. 7,143,923, entitled SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL, which issued on Dec. 5, 2006, the entire disclosures of which are hereby incorporated by reference herein, although the present invention is not so limited. In various embodiments, rows of staples can be arranged in arcuate, curved, and/or curvi-linear arrangements to achieve the advantages and effects outlined herein and can be deployed by surgical staplers including those disclosed in U.S. patent application Ser. No. 11/652,165, entitled SURGICAL STAPLING DEVICE WITH A CURVED END EFFECTOR, which was filed on Jan. 11, 2007, the entire disclosure of which is hereby incorporated by reference herein. In at least one embodiment, referring toFIG. 80, for example, a staple cartridge can be configured to deploy concentric, or at least substantially concentric, rows of staples including a first row of staples having a first deformed height represented by dimension “M” and, in addition, a second row of staples having a second deformed height represented by dimension “L”. In various circumstances, such rows of staples can be deployed by surgical staplers including those disclosed in U.S. Pat. No. 5,271,544, entitled SURGICAL ANASTOMOSIS STAPLING INSTRUMENT, which issued on Dec. 21, 1993, the entire disclosure of which is hereby incorporated by reference herein.

Further to the above, the various staple cartridges disclosed herein can be disposable. In at least one embodiment, an expended staple cartridge, or an at least partially expended staple cartridge, can be removed from a surgical stapler and replaced with another staple cartridge. In other various embodiments, the staple cartridge may not be removable and/or replaceable during the ordinary use of the surgical instrument but, in some circumstances, may be replaceable while and/or after the surgical stapler is reconditioned as described in greater detail below. In various embodiments, the staple cartridge can be part of a disposable loading unit or end-effector which can further include a staple cartridge carrier, anvil, cutting member, and/or staple driver. In at least one such embodiment, the entire, or at least a portion of, the disposable loading unit or end-effector can be detachably connected to a surgical instrument and can be configured to be replaced.

While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Furthermore, the present invention has been discussed in terms of endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic” should not be construed to limit the present invention to a surgical stapling and severing instrument for use only in conjunction with an endoscopic tube (i.e., trocar). On the contrary, it is believed that the present invention may find use in any procedure where access is limited to a small incision, including but not limited to laparoscopic procedures, as well as open procedures. Moreover, the unique and novel aspects of the various staple cartridge embodiments of the present invention may find utility when used in connection with other forms of stapling apparatuses without departing from the spirit and scope of the present invention.