Surgical stapler having a closure mechanism

A surgical stapler comprising a first handle portion comprising a staple cartridge channel configured to receive a staple cartridge and a second handle portion comprising an anvil. The stapler further comprises a rotatable latch and a latch projection, wherein the latch is rotatably coupled to one of the first handle portion and the second handle portion and wherein the latch projection extends from the other of the first handle portion and the second handle portion. The latch is configured to engage the latch projection to move the first handle portion and the second handle portion toward one another. In various embodiments, the latch projection comprises a rotatable bearing wherein the latch is configured to contact the rotatable bearing when the latch engages the latch projection.

BACKGROUND

i. Technical Field

The present invention relates to stapling instruments and, in various embodiments, to a surgical stapling instrument for producing one or more rows of staples.

ii. Background of the Related Art

In recent years, there has been an increasing tendency for surgeons to use stapling instruments to suture body tissues such as a lung, an esophagus, a stomach, a duodenum and/or other organs in the intestinal tract. The use of an appropriate stapling instrument in many instances may perform a better job in less time and simplify previously difficult surgical procedures such as gastrointestinal anastomoses. Previous linear two and four row cutting staplers comprised cartridge-less instruments into which staples were individually hand-loaded. Other previous devices have included a presterilized disposable staple loading unit and a cutting member which could be utilized for dividing the tissue and forming the rows of staples simultaneously. An example of such a surgical stapler is disclosed in U.S. Pat. No. 3,499,591, entitled INSTRUMENT FOR PLACING LATERAL GASTROINTESTINAL ANASTOMOSES, which issued on Mar. 10, 1970, the entire disclosure of which is hereby incorporated by reference herein.

A stapling instrument can include a pair of cooperating elongate jaw members, wherein each jaw member can be adapted to be inserted into an internal, tubular body organ to be anastomosed. In various embodiments, one of the jaw members can support a staple cartridge with at least two laterally spaced rows of staples, and the other jaw member can support an anvil with staple-forming pockets aligned with the rows of staples in the staple cartridge. Generally, the stapling instrument can further include a pusher bar and knife blade which are slidable relative to the jaw members to sequentially eject staples from the staple cartridge via camming surfaces on the pusher bar. In at least one embodiment, the camming surfaces can be configured to activate a plurality of staple drivers carried by the cartridge and associated with the individual staples to push the staples against the anvil and form laterally spaced rows of deformed staples in the tissue gripped between the jaw members. In typical stapling instruments, however, the anvil is unmovable relative to the staple cartridge once the jaw members have been assembled together and the formed height of the staples cannot be adjusted. In at least one embodiment, the knife blade can trail the pusher bar and cut the tissue along a line between the staple rows. Examples of such stapling instruments are disclosed in U.S. Pat. No. 4,429,695, entitled SURGICAL INSTRUMENTS, which issued on Feb. 7, 1984, the entire disclosure of which is hereby incorporated by reference herein.

SUMMARY

In at least one form of the present invention, a surgical stapler can comprise a first handle portion comprising a staple cartridge channel configured to receive a staple, cartridge and a second handle portion comprising an anvil. The stapler further comprises a rotatable latch and a latch projection, wherein the latch is rotatably coupled to one of the first handle portion and the second handle portion and wherein the latch projection extends from the other of the first handle portion and the second handle portion. The latch is configured to engage the latch projection to move the first handle portion and the second handle portion toward one another. In various embodiments, the latch projection comprises a rotatable bearing wherein the latch is configured to contact the rotatable bearing when the latch engages the latch projection.

In at least one form of the present invention, a surgical stapler can comprise an anvil having a plurality of staple pockets formed in a tissue contacting surface. Each staple pocket can comprise a longitudinal axis, a first forming cup, and a second forming cup. The first forming cup can comprise a first interior sidewall comprising a first vertical portion which is substantially perpendicular to the tissue contacting surface. The second forming cup can comprise a second interior sidewall comprising a second vertical portion which is substantially perpendicular to the tissue contacting surface. In various embodiments, the first vertical portion and the second vertical portion can extend through the longitudinal axis, wherein the first interior sidewall and the second interior sidewall can comprise a trap for deforming a first staple leg of a staple to a first side of the longitudinal axis and for deforming a second staple leg of the staple to a second side of the longitudinal axis.

In at least one form of the present invention, a method for deforming a staple comprising a base, a first staple leg, and a second staple leg, wherein the base, the first staple leg, and the second staple leg are positioned within a common plane prior to being deformed, the method comprising positioning the first staple leg within a first cup of a staple pocket, the first cup comprising a first inner surface, applying a first compressive force to an end of the first staple leg to bend the first staple leg toward the base and the second staple leg, contacting the first inner surface with the end of the first staple leg to bend the end of the first staple leg toward a first side of the base, and deforming the first staple leg such that the end of the first staple leg crosses a mid-line of the staple defined between the first staple leg and the second staple leg.

DETAILED DESCRIPTION

The entire disclosures of the following commonly-owned, non-provisional U.S. patent applications are hereby incorporated by reference herein:

A METHOD FOR FORMING A STAPLE, filed on even date herewith, U.S. patent application Ser. No. 12/622,130, now U.S. Publication No. 2011/0087276; and

Referring toFIG. 1, a surgical stapling instrument, generally100, can comprise a first handle portion102and a second handle portion104. In various embodiments, first handle portion102and second handle portion104can be configured to be grasped by a surgeon, for example, and can comprise hand grip portion106. In at least one embodiment, first handle portion102, referring toFIGS. 2 and 3, can include a first cover108attached to a first frame110and, similarly, second handle portion104can include a second cover112attached to a second frame114. Covers108and112can be ergonomically contoured, or otherwise suitably contoured, to assist a surgeon in manipulating stapling instrument100within a surgical site. In various embodiments, handle covers108and112, for example, can include enlarged protrusions109and113, respectively, which can facilitate the insertion of stapling instrument100into a surgical site. In various embodiments, handle covers108and112can be made of plastic, lightweight materials, and/or any other suitable material, for example, while handle frames110and114can be made of stainless steel, titanium, and/or any other suitable material, for example.

In various embodiments, referring again toFIGS. 1-3, the distal ends of handle portions102and104can comprise an end-effector120which can be configured to treat tissue within a surgical site, for example. In at least one such embodiment, end-effector120can include a staple cartridge channel122configured to receive and/or retain a staple cartridge as described in greater detail further below. In certain embodiments, staple cartridge channel122can comprise a one-piece elongated channel-shaped frame extending from first handle portion frame110. In at least one embodiment, staple cartridge channel122can include a pair of opposed, elongated side walls124connected by a bottom wall126. Along the rearward, or proximal, portion of staple cartridge channel122, a pair of spaced, upstanding side flanges128can extend upwardly from opposed side walls124. In various embodiments, the width of staple cartridge channel122between side flanges128can be greater than the width of the upper jaw member, or anvil,130extending from second handle portion104. In at least one embodiment, the distance between flanges128can be configured to permit at least a portion of anvil130to be received between side flanges128when the stapling instrument is assembled for operation. As shown inFIG. 2, each side flange128of can include a notch, or recess,127, for example, which can be configured to receive one or more latch projections131, for example, extending from anvil130, and/or any other suitable portion of second handle portion104, as described in greater detail further below.

As indicated above, referring once again toFIGS. 1-3, staple cartridge channel122can be configured to support and/or retain a staple cartridge, such as staple cartridge150, for example, within end-effector120, wherein the staple cartridge can include one or more staples (not illustrated) removably stored therein. In various embodiments, referring toFIGS. 8-10, staple cartridge150can include one or more staple cavities151which can be configured to store staples in any suitable arrangement, such as in at least two laterally-spaced longitudinal rows, for example. In at least one embodiment, referring toFIGS. 9 and 10, staple cartridge150can include staple cartridge body152and pan154, wherein staple cartridge body152and/or pan154can be configured to define a channel, or path, for slidably receiving a staple sled and/or cutting member therein. In at least one embodiment, pan154can include flexible arms155, for example, which can be configured to engage staple cartridge body152in a snap-fit and/or press-fit arrangement. Referring toFIGS. 10-12, staple cartridge150can further include staple sled assembly160which can include staple sled portion162and, in addition, cutting member164. In various embodiments, cutting member164can include cutting edge165and lock arm166, for example, wherein lock arm166can be configured to be press-fit and/or snap-fit into aperture163in staple sled162when cutting member164is assembled to staple sled portion162. In other various embodiments, staple sled portion162can be integrally molded to cutting member164.

Further to the above, referring toFIGS. 8-10, staple cartridge body152can include a slot, such as slot156, for example, which can be configured to receive at least a portion of cutting member164therein, and/or any other portion of staple sled assembly160and pusher bar assembly200(discussed below), wherein slot156can be configured to permit cutting member164to be moved between first and second positions within staple cartridge150. In various embodiments, slot156can be configured to permit cutting member164to be moved between a proximal position (FIG. 10) and a distal position in order to incise tissue positioned intermediate staple cartridge150and anvil130, for example. Referring again toFIGS. 10-12, staple sled portion162can include cam, ramp, or actuator, surfaces167which can be configured to engage staple drivers positioned within staple cartridge150. In various embodiments, referring toFIG. 9, staple cartridge150can include staple drivers168which can be lifted, or slid, upwardly within staple cavities151by sled portion162such that the upward movement of staple drivers168can eject, or deploy, staples at least partially positioned within staple cavities151. While staple drives168can be, in fact, lifted vertically upwardly, the term upward, and the like, can mean that staple drivers168, for example, are moved toward the top surface, or deck,158of the staple cartridge and/or toward anvil130, for example. In certain embodiments, as illustrated inFIG. 9, each staple driver168can include one or more sloped surfaces169oriented at the same angle as a cam surface167, and/or any other suitable angle, which can provide a relatively flat, or at least substantially flat, sliding contact surface between staple sled162and staple drivers168. In various embodiments, a staple driver can be configured to deploy only one staple, while, in certain embodiments, a staple driver can be configured to simultaneously deploy two or more staples located in adjacent rows, for example. Other devices are disclosed in U.S. patent application Ser. No. 12/030,424, entitled SURGICAL STAPLING INSTRUMENT WITH IMPROVED FIRING TRIGGER ARRANGEMENT, which was filed on Feb. 13, 2008, the entire disclosure of which is incorporated by reference herein.

In various embodiments, as described above, a surgical stapling instrument can include a cutting member/staple sled assembly configured to incise tissue and deploy staples from a staple cartridge. In certain embodiments, though, a surgical stapling instrument may not require, or include, a cutting member. In at least one such embodiment, a staple cartridge can include a staple sled positioned therein and/or a surgical instrument can be configured to move a staple sled into a staple cartridge in order to staple tissue, for example, without otherwise dissecting it. In certain other embodiments, a staple cartridge can include a staple sled positioned therein where a surgical instrument can include a cutting member movable into, or relative to, the staple cartridge. In at least one such embodiment, the cutting member can be advanced into contact with the staple sled such that the cutting member and staple sled can be advanced together. Thereafter, the cutting member can be sufficiently retracted to allow the staple cartridge to be detached from the surgical instrument and replaced with a new staple cartridge having a new staple sled. Such embodiments may be useful when a staple sled may become worn or deformed during use. Other embodiments are envisioned where a staple cartridge can include a cutting member positioned therein where a surgical instrument can include a staple sled movable into, or relative to, the staple cartridge. In at least one such embodiment, similar to the above, the staple sled can be advanced into contact with the cutting member such that the cutting member and staple sled can be advanced together. Thereafter, the staple sled can be sufficiently retracted to allow the staple cartridge to be detached from the surgical instrument and replaced with a new staple cartridge having a new cutting member. Such embodiments may be useful when a cutting member may become worn or deformed during use. In various embodiments, as described in greater detail below, the staple cartridge can include a protective housing or cover configured to prevent, or at least reduce the possibility of, a surgeon or other clinician from touching the cutting member positioned within the staple cartridge while handling the staple cartridge, for example.

In various embodiments, further to the above, staple cartridge channel122and/or staple cartridge150, for example, can include one or more co-operating projections and/or recesses, for example, which can be configured to removably retain staple cartridge150within staple cartridge channel122. Once staple cartridge150has been inserted into staple cartridge channel122, in various embodiments, the first handle portion102can be assembled to the second handle portion104. In other various embodiments, the staple cartridge may be inserted into the staple cartridge channel after the first and second handle portions have been assembled together. In either event, referring toFIGS. 1-7, first handle portion102and second handle portion104can include proximal ends103and105, respectively, which can be assembled together such that the first and second handle portions can be rotatably or pivotably coupled to one another. In various embodiments, referring toFIGS. 2 and 3, first handle portion102can include one or more pins, or projections,111extending therefrom which can be configured to be slidably received within one or more grooves, channels, or slots115in second handle portion104. In certain embodiments, slots115can be defined in second handle frame114and projections111can extend from a proximal end post107extending from first handle frame110, for example. In order to assemble first handle portion102and second handle portion104, referring toFIG. 4, the open ends of slots115can be aligned with projections111such that second handle portion104, for example, can be translated relative to first handle portion102and projections111can be slid within slots115. In at least one embodiment, as illustrated inFIGS. 2 and 3, the open ends of slots115can be located proximally with respect to their closed ends. In at least one such embodiment, proximal end105of second handle portion104can be positioned distally with respect to proximal end103of first handle portion102such that second handle portion104can be moved proximally in order to position projections111within slots115. In various other circumstances, first handle portion102can be positioned proximally with respect to second handle portion104and slid distally in order to position projections111within slots115.

In various embodiments, referring toFIG. 5, second handle portion104can be rotated toward first handle portion102such that anvil130can be moved into position relative to staple cartridge150and/or staple cartridge channel122. In certain embodiments, first handle portion102can be rotated toward second handle portion104and/or the first and second handle portions can be rotated toward each other. In any event, projections111and slots115, when engaged with one another, can comprise a pivot about which one or both of the first and second handle portions can be moved relative to each other. In various embodiments, second handle portion104can be moved relative to first handle portion102such that anvil130is moved into close opposition to staple cartridge150. In certain embodiments, referring toFIG. 6, second handle portion104can be moved relative to first handle portion102such that latch projections131extending from second handle portion104can be aligned with and/or inserted into recesses127within first handle portion102. In various embodiments, referring primarily toFIGS. 2 and 3, first handle portion102can further include latching mechanism180rotatably mounted thereto which can be utilized to engage latch projections131extending from second handle portion104and secure the first and second handle portions together. Although not illustrated, other embodiments are envisioned in which a latching mechanism is rotatably mounted to the second handle portion and latch projections can extend from the first handle portion. In any event, in at least one embodiment, latching mechanism180can be mounted to first frame110by one or more pivot pins182which can be configured to define an axis about which latch180can be rotated.

In certain embodiments, referring now toFIGS. 4 and 5, latching mechanism180can include latch frame184and, in addition, latch cover186assembled to latch frame184. In other various embodiments, the latch cover and the latch frame can comprise an integral unit or, in certain embodiments, the latching mechanism may not even include a cover. In certain embodiments, latch frame184can be channel-shaped and can include a pair of opposed, elongated side walls185which are spaced apart by a distance sufficient to span first frame portion110. In at least one embodiment, latch cover186can be made of plastic, lightweight materials, and/or any other suitable materials, for example, while latch frame184can be made of stainless steel and/or any other suitable material, for example. In certain embodiments, when latching mechanism180is closed, as illustrated inFIG. 7, latch cover186can be aligned with first handle cover108. Latch cover186can include contoured portion187which can be configured to assist a surgeon in manipulating surgical instrument100wherein, in at least one embodiment, contoured portion187can be aligned with, or at least substantially aligned with, protrusion109extending from first handle cover108. Latching mechanism180can further include one or more latch arms188extending therefrom which can be configured to engage one or more latch projections131extending from second handle portion104and pull and/or secure projections131within recesses127as illustrated inFIG. 7. In at least one embodiment, at least one of latch arms188can be integrally-formed with latch frame184. In certain embodiments, referring toFIG. 6, at least one of latch arms188can include a distal hook189which can be configured to wrap around at least a portion of projections131so as to encompass or surround, or at least partially encompass or surround, projections131. In at least one embodiment, latch arms188can act as an over-center latch to maintain latching mechanism180in its latched, or closed, position.

In use, in various circumstances, one of the first handle portion102and the second handle portion104can be positioned on a first side of tissue within a surgical site and the other handle portion can be rotated into position on the opposite side of the tissue. In such embodiments, staple cartridge150can be positioned on one side of the tissue and anvil130can be positioned on the other side of the tissue. Thereafter, as also outlined above, latching mechanism180can be actuated such that it can be moved between an open position and a closed position in order to latch second handle portion104to first handle portion102and apply a clamping force to the tissue positioned between staple cartridge150and anvil130. In certain circumstances, latching mechanism180can be moved between an open position (FIG. 5), a partially-closed, or intermediate, position (FIG. 6), and a closed position (FIG. 7). In at least one such embodiment, referring toFIGS. 5 and 6, latching mechanism180can be moved between an open position in which latch arms188are not engaged with projections131and a partially-closed position in which latch arms188are engaged with projections131such that, although anvil130has been at least partially brought into opposition to staple cartridge150, a sufficient gap can remain between anvil130and staple cartridge150which can allow end-effector120to be repositioned relative to the tissue, for example. Once the anvil130and staple cartridge150have been sufficiently positioned relative to the tissue, latching mechanism180can be moved between its partially-closed position and a closed position, as illustrated inFIG. 7.

In various embodiments, further to the above, a surgical stapling instrument can further include a biasing member which can be configured to bias the first handle portion of a stapling instrument away from a second handle portion. In at least one embodiment, as described in greater detail further below, a spring, and/or any suitably resilient material, can be positioned intermediate the first and second handle portions such that the anvil and staple cartridge of the stapling instrument can be biased away from each other. In certain embodiments, the spring can be configured to at least partially separate the first and second handle portions such that a gap exists between the anvil and the staple cartridge, wherein the gap can be sufficient to allow tissue to be positioned therebetween. In use, a surgeon can position such a surgical stapling instrument without having to separate and hold the first and second handle portions apart from each other. Such an instrument may be especially useful when the stapling instrument is in a partially-closed configuration and the surgeon is manipulating the instrument within a surgical site. After the surgeon is satisfied with the positioning of the stapling instrument, the surgeon can compress and/or disengage the spring and place the stapling instrument in a closed configuration.

In various circumstances, as outlined above, the distal end of first handle portion102can be moved relative to the distal end of second handle portion104, especially when latching mechanism180is not engaged with, or only partially engaged with, projections131of second handle portion104. In such circumstances, projections111and slots115at the proximal ends of the first and second handle portions can be configured to retain at least the proximal ends of the first and second handle portions together when the distal ends of the first and second handle portions are being moved relative to each other, for example. Stated another way, projections111and slots115can cooperate to prevent, or at least inhibit, first handle portion102from becoming completely detached from second handle portion104. In certain embodiments, a first handle portion can include a first lock portion and a second handle portion can include a second lock portion, wherein the first and second lock portions can be configured to be engaged with one another and prevent the first handle portion from becoming completely detached from the second handle portion. In at least one embodiment, projections111can comprise the first lock portion and slots115can comprise the second lock portion. Previous stapling instruments lacked such lock portions and instead relied on a sole latching mechanism to keep the first and second handle portions together. In circumstances where the latching mechanisms of these previous stapling instruments were not fully engaged with both of the first and second handle portions, the first and second handle portions could become completely detached from one another, thereby requiring a surgeon, for example, to reposition and reassemble the handle portions. In certain circumstances, a complete detachment of the first and second handle portions of these previous staples could expose at least a portion of a cutting member.

In various embodiments, as outlined above, latching mechanism180can be configured to be moved between an open position, a partially-closed position, and a closed position. When latching mechanism180is in its open position, as also outlined above, projections111can be inserted into and/or removed from slots115. When latching mechanism180is in its partially-closed position, referring toFIG. 6, latch arms188can be configured to engage latch projections131such that projections111cannot be removed from slots115. In at least one such embodiment, latch arms188and latch projections131can be configured to prevent, or at least inhibit, second handle portion104from being moved distally with respect to first handle portion102and, as a result, prevent, or at least inhibit, projections111from being disengaged from slots115. Correspondingly, latch arms188and latch projections131can be configured to prevent first handle portion102from being moved proximally with respect to second handle portion104. Similar to the above, in various embodiments, latch arms188and latch projections131can also be configured to prevent, or at least inhibit, projections111from being removed from slots115when latching mechanism180is in its closed position (FIG. 7). In certain embodiments, further to the above, latch projections131can extend from second handle portion104at a location which is intermediate its proximal and distal ends. In at least one such embodiment, projections111and slots115can be configured to hold the first and second handle portions together at their proximal ends while latching mechanism180can be utilized to hold the first and second handle portions together at an intermediate location. In any event, in certain embodiments, the first and second handle portions cannot be disengaged from one another unless latching mechanism180is moved into its fully open position. In at least one such embodiment, projections111and slots115cannot be disengaged from one another when latching mechanism180is in a closed and/or partially-closed position.

Once anvil130and staple cartridge150have been sufficiently positioned, the tissue positioned intermediate anvil130and staple cartridge150can be stapled and/or incised. In various embodiments, referring toFIG. 3, surgical stapling instrument100can further include pusher bar assembly200which can be configured to advance and/or retract staple sled assembly160within staple cartridge150, for example. In at least one embodiment, pusher bar assembly200can include pusher bar202and firing actuator204, wherein firing actuator204can be configured to move pusher bar202and staple sled assembly160distally to deploy staples from staple cartridge150and deform the staples against anvil130as described above. In at least one embodiment, referring toFIGS. 11 and 12, staple sled162can include a groove, channel, or slot161which can be configured to receive, and can be operably connected to, a distal end201(FIG. 3) of pusher bar202. In certain embodiments, staple sled assembly160can be operably engaged with pusher bar202when staple cartridge150is inserted into staple cartridge channel122. In at least one embodiment, distal end201and slot161can include cooperating features which can allow distal end201and slot161to be assembled in a transverse direction but prevent, or at least inhibit, distal end201and slot161from being disassembled from one another in a proximal direction and/or distal direction. In other embodiments, pusher bar202can be advanced distally before contacting and engaging staple sled assembly160. In at least one such embodiment, the staple sled assembly160can remain stationary until contacted by pusher bar202. In any event, as outlined above, actuator204can be operably connected to pusher bar202such that a pushing and/or pulling force can be applied to actuator204and transmitted to pusher bar202. In certain embodiments, as described in greater detail below, actuator204can be pivotably connected to a proximal end203of pusher bar202such that actuator204can be selectively rotated between at least first and second positions.

Further to the above, referring toFIGS. 1,13, and14, actuator204can be movable between a first position on a first side116of surgical stapling instrument100(FIG. 13), a second position on a second side117(FIG. 14), and an intermediate position (FIG. 1) located at the proximal ends103and105of the first and second handle portions102and104. Once actuator204has been rotated into position on one of the first and second sides116,117, actuator204can be advanced distally. In various circumstances, as a result, a surgeon may select whether to move actuator204distally along first side116or second side117. Such circumstances may arise when it is more likely that actuator204may impinge on tissue surrounding the surgical site, for example, when actuator204is moved distally along one side of the surgical instrument as compared to the other. In various embodiments, referring toFIGS. 2 and 3, actuator204can include arm206extending therefrom where arm206can be pivotably mounted to proximal end203of pusher bar202. In certain embodiments, referring once again toFIGS. 1,13, and14, surgical instrument100can include a first slot (not illustrated) extending along first side116and a second slot118extending along second side117, wherein the first and second slots can be configured to slidably receive at least a portion of actuator204. In at least one embodiment, the sidewalls of the first and second slots can confine, or at least assist in confining, the movement of actuator204such that it can be moved along a predetermined path. Referring toFIG. 14, second slot118, for example, can be defined between first handle portion102and second handle portion104such that, when actuator204is moved distally along second side117, arm206of actuator204can be slid intermediate the first and second handle portions. Similar to the above, the first slot can also be defined intermediate the first and second handle portions. In various embodiments, referring again toFIGS. 13 and 14, surgical instrument100can further include intermediate slot119which can also be configured to allow arm206, and/or any other suitable portion of actuator204, to slide therein. In at least one such embodiment, intermediate slot119can connect the first and second slots such that, when actuator204is positioned in its intermediate position, actuator204can be moved into either one of its first and second positions. In certain embodiments, the first slot, second slot117, and intermediate slot119can be parallel, or at least substantially parallel, to one another and/or lie in the same plane, although other embodiments are envisioned in which one or more of the slots is not parallel to the others and/or lies in a different plane. Furthermore, although the first and second sides of the illustrated embodiment are located on opposite sides of surgical instrument100, other embodiments are envisioned where the first and second slots, for example, are located on adjacent sides and/or sides which are not directly opposite to each other. Furthermore, other embodiments are envisioned in which the sides of a stapling instrument are not readily discernable, such as instruments having round and/or arcuate portions.

In various embodiments, further to the above, surgical stapling instrument100can further include a locking mechanism which can prevent, or at least inhibit, actuator204and, correspondingly, staple sled assembly160, from being advanced prematurely. In at least one embodiment, the locking mechanism can be configured to prevent, or at least inhibit, actuator204from being advanced distally prior to latching mechanism180being moved into a closed, or an at least partially-closed, position. In certain embodiments, generally referring toFIG. 5, surgical stapling instrument100can further including locking mechanism220which can be engaged with actuator204and can remain engaged with actuator204while latching mechanism180is in a fully open position (FIG. 5) and/or an at least substantially-open position. In various embodiments, locking mechanism220can include lock222which can be biased into engagement with actuator204by a biasing force applied thereto by lock spring224, for example. In at least one such embodiment, actuator204can include one or more grooves, channels, or slots (not illustrated) which can be configured to receive at least a portion of lock222. In use, locking mechanism220can hold actuator204in position until latching mechanism180is moved into its fully closed position (FIG. 7) and/or an at least substantially closed position. In such circumstances, in at least one embodiment, latching mechanism180can be configured to engage locking mechanism220and disengage lock222from actuator204. In at least one such embodiment, referring toFIGS. 5-7, latching mechanism180can further include cam183which can be configured to engage cam surface223on lock222when latching mechanism180is moved into its closed position and, as a result, slide, and/or otherwise move, lock222away from actuator204. In various embodiments, cam183can comprise a wall, rib, and/or ridge extending from latch cover186and/or latch frame184. In any event, once lock222has been sufficiently disengaged from actuator204, in at least one embodiment, actuator204can be moved from its intermediate position, illustrated inFIG. 1, into one of its first and second positions, as illustrated inFIGS. 13 and 14.

As described above, locking mechanism220can be configured to prevent, or at least inhibit, drive bar202from being advanced distally prior to latching mechanism180being moved into a predetermined position, such as, for example, a closed position and/or partially-closed position. Advantageously, locking mechanism220may also prevent, or at least inhibit, staple sled assembly160from being advanced prior to the first handle portion102and the second handle portion104being assembled together. In effect, locking mechanism220can prevent tissue positioned intermediate anvil130and staple cartridge150from being cut and/or stapled prior to anvil130and staple cartridge150being properly positioned relative to the tissue. Also, in effect, locking mechanism220can prevent staples from being deployed into the tissue prior to an appropriate clamping force being applied to the tissue. In any event, when latching mechanism180is returned to its fully open position, and/or a partially-open position, cam183can be moved away from lock222such that lock spring124can bias lock222into engagement with actuator204once again. In various other embodiments, referring toFIGS. 15 and 16, locking mechanism220′ can include a lock222′ comprising a cam surface223′ and, in addition, a stop226′ which can limit the relative movement of lock222′. In at least one embodiment, cam183, for example, can be configured to contact cam surface223′ and, owing to the contoured, beveled, and/or angled surface of cam surface223′, cam183can be configured to drive lock222′ distally as illustrated inFIG. 16. Lock222′ can be driven distally such that pin228′, which extends from lock222′, can be moved between a first position (FIG. 15) in which it is positioned within aperture229′ in actuator204′ and a second position (FIG. 16) in which pin228′ has been sufficiently removed from aperture229′. In various embodiments, stop226′ can be configured such that, as lock222′ is driven distally, stop226′ can come into contact with cam183once lock222′ has been sufficiently displaced. In such embodiments, stop226′ can be configured to control the second, or displaced, position of lock222′. Similar to the above, as actuator180is moved out of its closed position and cam183is disengaged from locking mechanism220′, lock spring224′ can move lock222′ into engagement with actuator204′ once again.

In various embodiments, as described above, a firing actuator can be utilized to move a pusher bar, staple sled, and/or cutting member between first and second positions. As also described above, pusher bar assembly200, for example, can be utilized to move a staple sled assembly, such as staple sled assembly160, for example, between a proximal position (FIG. 10) and a distal position. In certain embodiments, a staple cartridge, such as staple cartridge150, for example, can include a staple sled assembly160contained therein, wherein staple sled assembly160can be positioned in a distal position, as illustrated inFIG. 10, when the staple cartridge is assembled to or inserted into staple cartridge channel122. In at least one such embodiment, referring toFIGS. 8-10, staple cartridge150can include further housing170which can be configured to cover at least a portion of cutting member164when staple sled assembly160is in its distal position, for example. In various embodiments, housing170can be configured to protect a surgeon, for example, when handling the staple cartridge, when inserting the staple cartridge into the surgical stapler, and/or assembling two or more portions of the surgical stapler together, for example. In at least one such embodiment, at least an upper portion of cutting edge165can extend above deck, or top surface,158of staple cartridge150and, absent a protective housing, such as housing170, for example, the upper portion of cutting edge165may be exposed.

In various embodiments, as described above, cutting member165can be at least partially positioned within slot; or channel,156and, as illustrated inFIG. 10, at least the upper, or top, portion of cutting member164can extend above deck158. In at least one embodiment, referring toFIGS. 8-10, housing170can include a first wall, or portion,172extending from a first portion157of staple cartridge body152, a second wall, or portion,174extending from a second portion159of staple cartridge body152, and a top wall, or portion,176extending between first wall172and second wall174. In certain embodiments, a housing may comprise only one support wall, or support portion, extending from a staple cartridge body and, in addition, a top wall, or top portion, extending therefrom. In other embodiments, a housing may comprise one or more side walls, or portions, and no top wall. In at least one such embodiment, the side walls of the housing can be configured such that they extend above the top of the cutting member, or at least extend above a cutting edge of the cutting member, for example. In any event, as illustrated inFIG. 10, at least a portion of cutting member164can be positioned underneath top wall176and/or between side walls172and174when staple sled assembly160is in its proximal position. In certain embodiments, cutting member164can be entirely positioned underneath top wall176, and/or entirely positioned within housing170. In at least one embodiment, cutting member164can be positioned underneath top wall176such that cutting surface165does not extend beyond the distal edge175and/or the proximal edge177of top wall176. In at least one embodiment, housing170can include a rear wall178which can be configured to limit the proximal movement of cutting member164and/or any other portion of staple sled assembly160. In various embodiments, at least a portion of housing170, for example, can be integrally-formed with staple cartridge body152. In at least one such embodiment, first wall172, second wall174, top wall176, and/or rear wall178can be formed when staple cartridge body152is injection molded, for example. In certain embodiments, at least a portion of housing170can be assembled to staple cartridge body152via a snap-fit arrangement, press-fit arrangement, and/or any other suitable manner.

In various embodiments, further to the above, cutting member164can be defined by a planar, or an at least substantially planar, body having a knife edge extending along at least one side of the cutting member body. In at least one such embodiment, first wall172and/or second wall174can be configured and arranged such that they can include planar, or at least substantially planar, interior surfaces173which are parallel, or at least substantially parallel, to the side surfaces of cutting member164. In certain embodiments, cutting member164can be closely received between the interior surfaces173of walls172and174. In at least one such embodiment, the distance between walls172and174may be the same as, or at least substantially the same as, the width of slot156. In any event, a housing can be configured such that at least a portion of the housing extends over at least a portion of slot156, for example. In certain embodiments, housing170can completely enclose or surround a cutting member164and/or cutting surface165. In at least one embodiment, although not illustrated, a housing can include a break-away and/or incisable portion which can be at least partially detached, separated, and/or otherwise deformed in order to permit a cutting member to exit the housing. In at least one such embodiment, the tissue cutting surface can be configured to contact the housing to break and/or incise a housing wall, for example. In various embodiments, the housing wall can include a thin portion, a reduced-thickness portion, score mark, and/or any other configuration to facilitate the deformation and/or incision of the housing wall. In certain embodiments, a cutting member can include one or more additional cutting surfaces and/or anvils, for example, which can be configured to deform and/or incise the housing. In at least one embodiment, the housing can include a movable and/or flexible portion, such as a hinged member and/or flexible flap, for example, which can be configured to sufficiently move and/or flex to allow the cutting member to pass thereby. In any event, embodiments are envisioned in which the cutting member can have any suitable configuration for incising tissue and the protective housing can have any suitable configuration for at least partially enclosing or surrounding the cutting member. Furthermore, although a cutting member can comprise a sharpened edge as described above, other suitable cutting members are envisioned, such as those supplied with an electrical current sufficient to dissect tissue, for example.

As described above, housing170can be configured to at least partially cover, enclose, and/or surround a cutting member when it is in its proximal position. In various embodiments, the cutting member can be advanced distally to incise tissue, for example, and then retracted proximally in order to position the cutting member within housing170once again. In such embodiments, the cutting member can be at least partially covered by housing170when the staple cartridge is assembled to and removed from a surgical stapling instrument. In certain embodiments, a new, or unspent, staple cartridge can be inserted into the staple cartridge channel to replace the at least partially spent staple cartridge. In at least one such embodiment, the new staple cartridge can include a new cutting member and/or staple sled assembly positioned therein, although embodiments are envisioned in which the previously-used cutting member and/or staple sled assembly can be sufficiently withdrawn from the spent staple cartridge and advanced into the new staple cartridge in order to be reused once again. In embodiments where a new cutting member and/or staple sled assembly is provided with each new staple cartridge, a sharp cutting edge, for example, can be utilized with each staple cartridge.

In various embodiments, although not illustrated, a staple cartridge can include two or more housings configured to at least partially cover a cutting member when it is in two or more positions. In at least one embodiment, a staple cartridge can include a proximal housing configured to at least partially cover the cutting member when it is in a proximal position, for example, and, in addition, a distal housing configured to at least partially cover the cutting member when it is in a distal position, for example. In at least one such embodiment, the cutting member can be positioned within the proximal housing when the staple cartridge is assembled to a surgical stapling instrument and, in certain embodiments, the cutting member can be advanced into the distal housing after it has transected tissue positioned within the end-effector, for example. In such embodiments, as a result, the cutting member can be at least partially positioned within the distal housing when the staple cartridge is removed from the surgical stapler. Such embodiments may be particularly useful when a vessel, for example, is positioned intermediate the proximal housing and the distal housing of the staple cartridge. In various embodiments, although not illustrated, a cutting member can be moved proximally from a distal position to a proximal position, and/or any other suitable position.

In various embodiments, further to the above, anvil130can include one or more apertures, slots, or recesses179(FIG. 17) which can be configured to receive at least a portion of housing170when anvil130is brought into close opposition to staple cartridge150, for example. In at least one embodiment, sufficient clearance can be present between housing170and recess179such that anvil130and staple cartridge150can be moved relative to each other without interference, or at least substantial interference, therebetween. In embodiments having more than one cutting member housing as outlined above, an opposing anvil can have more than one corresponding aperture for receiving the housings. In various embodiments, an anvil can include a movable cutting member and at least one housing for at least partially covering, enclosing, and/or surrounding the cutting member. In certain embodiments, although not illustrated, both an anvil and a staple cartridge can comprise at least one movable cutting member and/or at least one housing configured to at least partially cover, surround, or enclose the cutting members when they are in a proximal position, for example.

As outlined above, pusher bar assembly200can be advanced distally in order to move staple sled assembly160within staple cartridge assembly150. In various embodiments, as also outlined above, the wedge-like cam surfaces167of staple sled162can be moved into engagement with the sloped surfaces169on staple drivers168to sequentially, and/or simultaneously, drive staples from staple cartridge150against anvil130and form the staples into any suitable configuration, such as B-shaped configurations, for example. In at least one such embodiment, referring toFIG. 17, anvil130can include one or more staple forming surfaces, such as staple pockets132, for example, which can be configured to deform the staples. In certain embodiments, anvil130can further include a slot, channel, or groove133which can be configured to slidably receive at least a portion of staple sled162, cutting member164, and/or pusher bar202, for example. In at least one embodiment, although not illustrated, an anvil can include an anvil plate which can be securely and/or immovably positioned within an anvil channel defined within the anvil. In various other embodiments, as illustrated inFIGS. 18 and 19and described in greater detail below, anvil130can include an anvil plate134movably positioned within anvil channel136. In certain embodiments, anvil channel136can include opposite side walls137and, in addition, a base138extending between side walls137. In at least one embodiment, anvil130can further include a distal nose portion139, for example, assembled thereto wherein nose portion139can be configured to be press-fit and/or snap-fit into anvil channel136, for example, such that nose portion139can be securely retained therein. In certain embodiments, nose portion139can be comprised of a soft and/or pliable material, such as rubber, for example, and can comprise any suitable shape which can facilitate the insertion of anvil130into a surgical site, for example. In some embodiments, referring toFIG. 28, a nose portion, such as nose portion139′ can be retained to an anvil by one or more fasteners139a′. Similarly, referring toFIG. 1, a staple cartridge channel and/or staple cartridge, such as staple cartridge150, for example, can include a nose portion, such as nose portion153, for example, which can facilitate the insertion of staple cartridge150into a surgical site, for example

As indicated above, staples can be deployed from a staple cartridge and deformed against an anvil. In various circumstances, the distance between the staple forming surfaces on anvil130and staple sled162can determine the amount in which the staples are deformed. For example, if the distance between anvil pockets132on anvil130and top surfaces135on staple sled162(FIGS. 10-12) is relatively large, the staples will be deformed a lesser amount as compared to when the distance between anvil pockets132and sled surfaces135is relatively small. Correspondingly, if the distance between anvil pockets132and sled surfaces135is relatively small, the staples will be deformed a greater amount as compared to when the distance between anvil pockets132and sled surfaces135is relatively large. Often, the distance between anvil pockets132and sled surfaces135is referred to as the forming height of the staples. Sometimes the forming height of the staples can be measured between the top surface, or deck, of the staple cartridge and the staple forming surfaces on the anvil. For the purpose of this application, however, any reference to a staple forming height, or the like, can include one or both manners of measurement, where appropriate, and/or any other suitable manner of measurement. In any event, as described in greater detail below, a surgical stapling instrument, such as stapling instrument100, for example, can include means for adjusting the staple forming height.

In various embodiments, further to the above, an anvil can include one or more forming surfaces which can be moved toward and/or away from a staple cartridge in order to set the forming height of the staples. In at least one embodiment, referring toFIGS. 17-23, anvil130can include anvil plate134which can be movably and/or slidably positioned within anvil channel136. In certain embodiments, anvil130can further include one or more retention, or guide, pins140, wherein anvil plate134can include one or more retention, or guide, slots141configured to slidably receive at least a portion of pins140. In at least one such embodiment, pins140and/or slots141can be configured to define a predetermined path along which anvil plate134can be moved. Referring toFIG. 18, pins140and slots141can be structured and arranged such that anvil plate134can be moved along a linear, or at least substantially linear, path, wherein the linear path can be at least partially defined by axes142and143, for example. Other embodiments are envisioned in which an anvil plate can be moved along a non-linear path, such as a curved and/or curvi-linear path, for example. In certain embodiments, at least a portion of pins140can be retained within apertures144in side walls137wherein, in at least one embodiment, pins140can be press-fit within apertures144. In any event, as described herein, pins140can guide anvil plate134as it is moved toward and/or away from staple cartridge150, for example.

In various embodiments, further to the above, a surgical stapling instrument, such as stapling instrument100, for example, can include one or more adjustment members configured to position a portion of an anvil, such as anvil plate134, for example, relative to other portions of an anvil assembly and/or an opposing staple cartridge. In certain embodiments, referring toFIGS. 18 and 19, stapling instrument100can include anvil plate adjustment member230which can be configured to limit the range of motion of anvil plate134. In at least one such embodiment, referring toFIGS. 20 and 21, adjusting member230can be positioned intermediate anvil plate134in a first position in which first surface, or step,231of adjusting member230is positioned intermediate base138of anvil channel136and first positioning surface145on anvil plate134. In such a first position, first step231can define the amount of relative movement possible, or permitted, between anvil plate134and anvil channel136. For example, when anvil130is clamped against tissue as described above, anvil plate134can contact the tissue and slide upwardly toward base138until first positioning surface145contacts first step231. Once surface145and step231are in contact, adjusting member230can prevent, or at least inhibit, anvil plate134from moving further toward base138. In at least one such embodiment, as a result, adjusting member230can act as a stop such that the distance between base138and tissue-contacting surface148on anvil plate134can be defined by a first distance234. While base138is used as a reference datum in the present example, other portions of anvil130and/or an opposing staple cartridge, for example, could be used as reference datums. When adjusting member230is in its first position, as described above, second surface, or step,232of adjusting member230can be positioned intermediate base138and second positioning surface146on anvil plate134, and, in addition, third surface, or step,233can be positioned intermediate base138and third positioning surface147. Referring toFIG. 20, adjustment member230can include two or more sets of steps,231,232, and/or233and anvil plate134can include two or more sets of positioning surfaces145,146, and/or147. While first step231and first positioning surface145are described above as being configured to control the position of anvil plate134, the second and third steps (232,233) of adjustment member230and the second and third positioning surfaces (146,147) of anvil plate134, respectively, can also be configured to control the position of anvil plate134. For the sake of brevity, though, the present example will be described in reference to the first surface, or step231, as being the surface which controls the position of anvil plate134, although the reader will understand that the steps232and233can control the position of anvil plate134as well.

In certain embodiments, the first position of adjustment member230can provide for a relatively small, or short, staple forming height. In other embodiments, although not illustrated, the first position of an adjustment member can provide for an intermediate, a relatively large, and/or any other suitable staple forming height. In the event that the forming height associated with the first position of the adjustment member is suitable, a surgeon can proceed to use the surgical stapling instrument to staple and/or incise tissue as described above. In the event, however, that the staple forming height is unsuitable, a surgeon, or other clinician, can move adjustment member230such that adjustment member230can permit anvil plate134to slide upwardly a different distance when anvil plate134contacts tissue positioned intermediate anvil130and staple cartridge150. In at least one such circumstance, the distance in which anvil plate134is permitted to slide upwardly can be larger, thereby providing a larger forming height for the staples. Correspondingly, in other circumstances, the adjustment member can be moved such that anvil plate134can slide upwardly a shorter distance when anvil plate134contacts the tissue, for example, thereby providing a shorter staple forming height. While the term “upward”, and the like, can mean vertically upward, the term is not so limited; rather, “upward” can mean any direction which is toward the base of the anvil and/or away from a staple cartridge, for example. In any event, adjustment member230can be moved between its first position, illustrated inFIG. 21, and a second position, illustrated inFIG. 22, in order to increase the staple forming height. As indicated by arrow “P” inFIG. 22, adjustment member230can be slid proximally in order to move adjustment member230between its first and second positions, although embodiments are envisioned where an adjustment member can be slid distally and/or any other suitable direction in order to adjust adjustment member230. Once adjustment member230has been moved into its second position, referring toFIG. 22, first surface, or step,231can be positioned intermediate base138and second positioning surface146of anvil plate134. In such a second position, first step231can once again define the amount of relative movement permitted between anvil plate134and anvil channel136. In at least one embodiment, similar to the above, adjusting member230can act as a stop such that the distance between base138and tissue-contacting surface148on anvil plate134can be defined by a second distance235.

Further to the above, adjustment member230can be moved between its second position, illustrated inFIG. 22, and a third position, illustrated inFIG. 23, in order to once again increase the staple forming height. As indicated by arrow “P” inFIG. 23, adjustment member230can be slid proximally in order to move adjustment member230between its second and third positions. Once adjustment member230has been moved into its third position, referring toFIG. 23, first surface, or step,231can be positioned intermediate base138and third positioning surface147. In such a third position, first step231can once again define the amount of relative movement between anvil plate134and anvil channel136. In at least one embodiment, similar to the above, adjusting member230can act as a stop such that the distance between base138and tissue-contacting surface148on anvil plate134can be defined by a third distance236. While adjustment member230can be selectively moved between three positions as described above to provide three different staple forming heights, other embodiments are envisioned which comprise an adjustment member which can be moved between more than three positions to provide more than three different staple forming heights. For example, an adjustment member can be movable between four positions in order to provide four staple forming heights. Further embodiments are envisioned which comprise an adjustment member which can be moved between two positions to provide two staple forming heights. Furthermore, while surfaces, or steps,231,232, and233of adjustment member230are arranged in a descending order, other arrangements are envisioned in which the surfaces, or steps, are arranged in an ascending order. Other arrangements are envisioned in which the surfaces, or steps, are not necessarily arranged in either an ascending or a descending order. Similarly, positioning surfaces145,146, and147of anvil plate134can be arranged in an ascending order, a descending order (FIG. 20), and/or any other suitable order. Furthermore, while adjustment member230can be slid along an axis, other embodiments are envisioned where an adjustment member can be moved along any suitable path such as curved and/or curvi-linear paths, for example.

As described above, referring toFIG. 21, adjustment member230can comprise three surfaces, or steps,231,232, and233while anvil plate134can comprise three corresponding adjustment surfaces145,146, and147. When adjustment member230is in its first position, for example, first surface231can be positioned such that it abuts or is adjacent to first adjustment surface145, second surface232can be positioned such that it abuts or is adjacent to second adjustment surface146, and third surface233can be positioned such that it abuts or is adjacent to third adjustment surface147. As adjustment member230is slid relative to anvil plate134, as described above and referring toFIGS. 22 and 23, surfaces231,232, and233of adjustment member230can be sequentially indexed relative to surfaces145,146, and147of anvil plate134. In at least one such embodiment, an adjustment member can have the same number of steps as the number of positioning surfaces on an anvil plate. Other embodiments are envisioned where an adjustment member has more steps than positioning surfaces on the anvil plate. In at least one such embodiment, an anvil plate can include one positioning surface wherein the steps of an adjustment member can be selectively utilized to limit the upward movement of the anvil plate, for example. In various embodiments, referring generally to adjustment member230and anvil plate134, an anvil plate may include one positioning surface, such as positioning surface145, for example, where steps231,232, and233of adjustment member230, for example, can be selectively positioned intermediate base138and positioning surface145. In such embodiments, first step231can have a first thickness or height which can stop, or limit, the upward movement of anvil plate134so as to define a first staple forming height, second step232can have a second thickness or height which can stop, or limit, the upward movement of anvil plate134so as to define a second staple forming height, and, in addition, third step233can have a third thickness or height which can stop, or limit, the upward movement of anvil plate134so as to define a third staple forming height. In at least one embodiment, the thickness or height of steps231,232, and/or233can be measured between a back surface237of adjustment member230and a surface on the steps (231,232,233) which will contact anvil plate134. In various embodiments, the difference in height, or thickness, between first step231and second step232can be the same, or at least substantially the same, as the difference in height, or thickness, between second step232and third step233. In at least one such embodiment, as a result, the step heights can increase at a linear rate, or an at least substantially linear rate. In alternative embodiments, the difference in height, or thickness, between the first and second steps can be different than the difference in height, or thickness, between the second and the third steps. In at least one such embodiment, the first, second, and third steps may not increase or decrease in height, or thickness, at a linear rate; rather, although not illustrated, the steps may increase or decrease in height, or thickness, in a non-linear and/or geometric rate.

As described above, an adjustment member, such as adjustment member230, for example, can be movable between two or more positions. In various embodiments, a surgical stapling instrument can include an actuator configured to move the adjustment member. In at least one embodiment, referring toFIGS. 17-20, surgical stapling instrument100can include actuator250which can be operably attached to adjustment member230such that a force can be applied to actuator250and transmitted to adjustment member230. In certain embodiments, actuator250can include grasping portions, or handles,252which can be configured to be grasped by a surgeon, for example, in order to advance or retract adjustment member230within anvil130as described above. In certain embodiments, grasping portions252can extend from actuator body251, wherein actuator body251can include one or more apertures, slots, or cavities253which can be configured to receive at least a portion of adjustment member230. In at least one such embodiment, referring toFIG. 19, adjustment member230can include lock254extending therefrom, wherein at least a portion of lock254can be received within aperture253so as to retain actuator body251to adjustment member230. In various embodiments, lock254can include one or more resilient, or flexible, legs255which can be deflected when they are inserted into aperture253but resiliently return, or at least partially return, to their unflexed position after feet256of legs255are sufficiently pushed through aperture253. In at least one such embodiment, feet256can prevent, or at least inhibit, actuator body251from being detached from adjustment member230.

In various embodiments, further to the above, surgical stapling instrument100can further include a detent mechanism which can be configured to hold, or releasably hold, actuator250and/or adjustment member230in position. In at least one embodiment, referring toFIG. 19, detent member260can be attached to actuator250wherein, in at least some embodiments, actuator body251can include one or more channels, grooves, or recesses257which can be configured to receive and/or retain a detent body261of detent member260therein. In at least one embodiment, detent body261can include one or more apertures263, and/or any other suitable channels, slots, or grooves, which can be configured to receive one or more fasteners for securing detent body261to actuator251, for example. Detent member260can further include detent legs262which can be configured to engage one or more recesses, apertures, or grooves101(FIGS. 2-7) in first frame portion110, for example. More particularly, referring toFIGS. 2 and 3, each side flange128can include one or more recesses101(101a,101b, and101c) defined therein wherein detent legs262can be biased into engagement with the top surfaces of side flanges128such that detent legs262can be slid into, and slid out of, recesses101. In the illustrated embodiment, each side flange can include three recesses101which can be configured to removably hold actuator250in a first, distal position, a second, intermediate position, and a third, proximal position, wherein the first, second, and third positions of actuator250can respectively correspond with the first, second, and third positions of adjustment member230described above. For example, when actuator250is in its first, distal position, detent legs262of detent member260can be positioned within recess101aso as to removably retain actuator250and adjustment member230in their first positions. Upon the application of a sufficient force, actuator250can be moved proximally into its second position such that detent legs162are positioned within recess101band actuator250and adjustment member230are retained in their second positions. Similarly, upon the application of a sufficient force, actuator250can be moved proximally into its third position such that detent legs162are positioned within recess101cand actuator250and adjustment member230are retained in their third positions. In various embodiments, detent legs162can be configured such that actuator250can be returned to its first and/or second positions.

As described above, adjustment member230can be moved along a pre-determined path between two or more positions by actuator250. In various embodiments, surgical stapling instrument100, for example, can include one or more guides for controlling or limiting the movement of adjustment member230and/or actuator250. In some embodiments, adjustment member230can be closely received between side walls137of anvil130such that side walls137can guide adjustment member230. In at least one such embodiment, side walls137can be configured to control or limit the lateral or side-to-side movement of adjustment member230. In various embodiments, detent legs162of detent member160can comprise resilient members which can be configured to apply an upward biasing or pulling force on adjustment member230so as to position adjustment member230against, or at least adjacent to, base138and intermediate side walls137. In certain embodiments, referring toFIG. 19, base138of anvil130can further include guide slot149which can be configured to receive at least a portion of adjustment member230and/or actuator250therein such that guide slot149can limit the movement of adjustment member230and actuator250. In at least one such embodiment, lock254of adjustment member230can be configured to extend through guide slot149such that, when lock254is inserted into aperture253of actuator250as described above, base138of anvil130can be captured intermediate adjustment member230and actuator250. In certain embodiments, guide slot149can be configured to limit the movement of lock254such that adjustment member230can be prevented, or at least inhibited, from being moved distally when adjustment member230is in its first, or distal-most, position and/or, similarly, prevented, or at least inhibited, from being moved proximally when adjustment member230is in its third, or proximal-most, position.

In various embodiments, further to the above, a detent member, similar to detent member260, for example, can be utilized to bias first handle portion102and second handle portion104away from one another. In at least one embodiment, referring toFIG. 37, surgical stapling instrument100′ can include a detent member260′ configured to position first handle portion102and second handle portion104such that a gap exists between anvil130and staple cartridge150. Such a feature, as outlined above, can allow a surgeon to easily manipulate the surgical instrument without having to hold the first and second handle portions apart from one another. In certain embodiments, detent member260′ can be sufficiently mounted to second handle portion104such that detent legs262′ extending from detent member260′ can contact flanges128and, when compressed, apply a biasing force to the first and second handle portions. As seen inFIG. 37, legs262′ can contact surfaces101don flanges128. In order to compress detent legs262′, latch mechanism180can be moved into a partially-closed position such that latch arms188can engage, and at least partially surround, latch projections131. In this configuration, a surgeon can manipulate the instrument and, when satisfied with its position, move latch mechanism180into a closed position and further compress detent legs262′. Similar to the above, detent member260′ can be affixed, or otherwise operably engaged with, actuator250such that, when actuator250is moved between its first, second, and third positions as described above, legs262′ can engage recesses101a,101b, and101c, respectively. In at least one such embodiment, as a result, actuator250can have a pre-staged position in which actuator250is positioned distally with respect to its first position and, in addition, surfaces101dcan comprise pre-stage surfaces against which legs262′ can be positioned when actuator250is in its pre-staged position.

As outlined above, an adjustment member can be slid, or translated, between first and second positions so as to adjust the forming height of staples deployed by a surgical stapling instrument. In various embodiments, although not illustrated, an adjustment member can be configured to positively displace an anvil plate toward and/or away from an opposing staple cartridge, for example. In at least one such embodiment, a surgical stapling instrument can include one or more biasing members, such as springs, for example, configured to position the anvil plate against the adjustment member such that, when the adjustment member is moved between its first and second positions, the adjustment member can displace the anvil plate between first and second positions in order to set first and second staple forming heights. In various embodiments, as a result of the above, an adjustment member can be configured to cam a portion of an anvil into position. In at least one such embodiment, an adjustment member can be slid along an axis in order to positively displace an anvil plate. In other embodiments, a rotatable adjustment member can be configured to positively displace an anvil plate toward and/or away from a staple cartridge, for example.

Further to the above, as described in greater detail below, an adjustment member can be rotated to adjust the staple forming height. Referring toFIGS. 24-36, surgical instrument100′ can include, similar to the above, a first handle portion102′, a second handle portion104′, and a latching mechanism180′ which can be utilized to clamp tissue intermediate anvil130′ and staple cartridge150′. Referring toFIG. 25, also similar to the above, latching mechanism180′ can be pivotably coupled to first portion102′ by one or more pivot pins182′, wherein latching mechanism180′ can include one or more latch arms188′ which can be configured to engage second portion104′ and latch the first and second handle portions together. Also similar to the above, referring toFIGS. 25 and 27, surgical instrument100′ can further include pusher bar assembly200′ which can be configured to advance a cutting member and/or staple sled within end-effector120′. In at least one such embodiment, pusher bar assembly200′ can include a proximal end203′ and an actuator204′, wherein actuator204′ can be rotatably mounted to proximal end203′ and selectively positioned on first and second sides of stapling instrument100′. In various embodiments, surgical stapling instrument100′ can comprise the same, or similar, features to those described in connection with surgical stapling instrument100and can be operated in the same manner, or a similar manner, as instrument100and, as a result, such details are not repeated herein.

In various embodiments, referring toFIG. 27, surgical instrument100′ can include a rotatable adjustment member230′ which can be selectively positioned in at least first and second positions so as to provide different staple forming heights. In certain embodiments, surgical instrument100′ can include an actuator250′ which can be operably connected to adjustment member230′ such that actuator250′ can move adjustment member230′ between at least its first and second positions. In at least one embodiment, referring toFIG. 28, actuator250′ can include actuator body251′ and grasping portion, or handle,252′. Actuator body251′ can include an aperture258′ which can be configured to receive a proximal end238′ of adjustment member230′ such that rotational motion, torque, and/or forces can be transmitted between actuator250′ and adjustment member230′. In at least one such embodiment, referring to FIG.36, aperture258′ can comprise a non-circular profile and/or a profile which includes one or more flat drive surfaces configured to transmit rotational motion between actuator body251′ and actuator230′. In certain embodiments, aperture258′ can be sized and configured to closely receive proximal end238′ of actuator230′. In at least one embodiment, aperture258′ can be configured to receive proximal end238′ in a press-fit and/or snap-fit arrangement. In various embodiments, referring again toFIG. 28, handle portion104′ can include one or more slots259′ which can be configured to permit at least a portion of actuator body251′ to extend therethrough such that grasping portion252′ can be assembled to actuator body251′ with at least a portion of handle portion104′ positioned therebetween. In at least one such embodiment, second handle portion104′ can further include recess253′ which can be configured such that at least a portion, if not all, of grasping portion252′ is positioned within recess253′. In certain embodiments, recess253′ can be configured such that grasping portion252′ does not extend above the top surface of second handle portion104′ although, in other embodiments, an upper portion of grasping portion252′ can extend above second handle portion104, as illustrated inFIG. 30, such that grasping portion252′ can be easily accessed by a surgeon.

In various embodiments, as outlined above, an adjustment member can be rotatable between at least first and second positions in order to adjust the forming height of staples deployed by a surgical stapler. In certain embodiments, referring toFIG. 28, a surgical stapling instrument can include an adjustment member rotatably positioned within an anvil wherein the adjustment member can be configured to limit the relative movement of a movable anvil portion. In at least one such embodiment, surgical stapling instrument100′ can include an anvil plate134′ which can be slidably retained within anvil channel136′ by retention, or guide, pins140′, wherein guide pins140′ can be configured to allow anvil plate134′ to slide upwardly when anvil plate134′ comes into contact with tissue as described above. Referring toFIGS. 27,30, and31, adjustment member230′ can be positionable in a first position, or orientation, such that it can limit the upward movement of anvil plate134′ within anvil channel136′ and dictate the staple forming height of the staples. In at least one such embodiment, referring toFIGS. 30 and 31, adjustment member230′ can include opposing first surfaces231′ which can be positioned intermediate base138′ of anvil channel136′ and positioning surface145′ of anvil plate134′ such that, when positioning surface145′ contacts one of first surfaces231′, tissue-contacting surface148′ of anvil plate134′ can be positioned a first distance234′ away from a datum surface129′ on anvil130′, for example. Correspondingly, forming surfaces132′ can be positioned a first distance away from a staple cartridge such that, when staples are deployed from the staple cartridge, the staples can be deformed to a first staple height. Further to the above, a first diameter241′ can be defined between first surfaces231′ wherein the first diameter241′ can define the maximum upward position of anvil plate134′ within anvil channel136′.

As indicated above, adjustment member230′ can be rotated in order to adjust the forming height of the staples. In various embodiments, adjustment member230′ can be rotated between its first position, or orientation, (FIGS. 30 and 31) and a second position, or orientation (FIGS. 32 and 33). In at least one embodiment, referring toFIGS. 32 and 33, handle252′ can be rotated in a direction indicated by arrow “A” in order to move adjustment member230′ between its first and second positions. Similar to the above, when actuator230′ is in its second position, or orientation, actuator230′ can limit the upward movement of anvil plate134′ within anvil channel136′ and dictate the staple forming height of the staples. In at least one such embodiment, referring toFIGS. 32 and 33, adjustment member230′ can include opposing second surfaces232′ which can be positioned intermediate base138′ and positioning surface145′ such that, when positioning surface145′ contacts one of second surfaces232′, tissue-contacting surface148′ of anvil plate134′ can be positioned a second distance235′ away from datum surface129′, for example. Correspondingly, forming surfaces132′ can be positioned a second distance away from a staple cartridge such that, when staples are deployed from the staple cartridge, the staples can be deformed to a second staple height. In various embodiments, similar to the above, a second diameter242′ can be defined between second surfaces232′, wherein second diameter242′ can define the maximum upward position of anvil plate134′ within anvil channel136′. Although first surfaces231′ and second surfaces232′ can be defined by flat, or at least substantially flat, surfaces, other embodiments are envisioned in which the first and second surfaces231′ and232′ can include at least partially arcuate, or curved, contours. In any event, referring toFIG. 27, adjustment member230′ may include one or more clearance slots240′ which can be configured to provide clearance between actuator230′ and retention pins140′. Clearance slots240′ can be configured to provide clearance between actuator230′ and retention pins140′ when actuator230′ is in its first position, second position, and/or any other suitable position.

In various embodiments, further to the above, adjustment member230′ can be rotated between its first position, or orientation, (FIGS. 30 and 31) and a third position, or orientation (FIGS. 34 and 35). In at least one embodiment, referring toFIGS. 34 and 35, handle252′ can be rotated in a direction indicated by arrow “B” in order to move adjustment member230′ between its first and third positions. Similar to the above, when actuator230′ is in its third position, or orientation, actuator230′ can limit the upward movement of anvil plate134′ within anvil channel136′ and dictate the staple forming height of the staples. In at least one such embodiment, referring toFIGS. 34 and 35, adjustment member230′ can include opposing third surfaces233′ which can be positioned intermediate base138′ and positioning surface145′ such that, when positioning surface145′ contacts one of third surfaces233′, tissue-contacting surface148′ of anvil plate134′ can be positioned a third distance236′ away from datum surface129′, for example. Correspondingly, forming surfaces132′ can be positioned a third distance away from a staple cartridge such that, when staples are deployed from the staple cartridge, the staples can be deformed to a third staple height. In various embodiments, similar to the above, a third diameter243′ can be defined between third surfaces233′, wherein third diameter243′ can define the maximum upward position of anvil plate134′ within anvil channel136′. Referring once again toFIGS. 34 and 35, third surfaces233′ can be defined by an at least partially arcuate contour, although other embodiments are envisioned in which third surfaces233′ can include flat, or at least substantially flat, contours. In at least one embodiment, adjustment member230′ can be configured such that the largest distance, or diameter, between the arcuate third surfaces233′ can be utilized to define the third staple height.

As described above, referring toFIGS. 30 and 31, adjustment member230′ can be positioned in a first position, or orientation, to set a first forming height for the staples deployed by surgical stapling instrument100′. As also described above, referring toFIGS. 32 and 33, actuator250′ can be utilized to move adjustment member230′ into its second position, or orientation, to set a second forming height for the staples. To do this, in at least one embodiment, a force can be applied to handle252′ which can cause handle252′, and adjustment member230′ attached thereto, to rotate in a direction indicated by arrow “A”. In at least one embodiment, adjustment member230′ and/or actuator250′ can be sufficiently retained such that, when adjustment member230′ is rotated, adjustment member230′ can be rotated about an axis, such as axis245′ (FIG. 27), for example. In at least one embodiment, referring toFIG. 25, the proximal end203′ of pusher bar assembly200′ can include one or more grooves, channels, or recesses205′ which can be configured to receive and/or retain at least a portion of adjustment member230′ and/or actuator250′ therein. In any event, as illustrated inFIGS. 30-33, the second position, or orientation, of adjustment member230′ can allow anvil plate134′ to slide a larger distance within anvil channel136′ as compared to when adjustment member230′ is in its first position. In at least one embodiment, as a result, the second staple forming height can be larger than the first staple forming height. As also described above, referring toFIGS. 34 and 35, actuator250′ can be utilized to move adjustment member230′ into its third position, or orientation, to set a third forming height for the staples. To do this, in at least one embodiment, a force can be applied to handle252′ which can cause handle252′, and adjustment member230′ attached thereto, to rotate in a direction indicated by arrow “B”. As illustrated inFIGS. 30,31,34, and35, the third position, or orientation, of adjustment member230′ can allow anvil plate134′ to slide a smaller distance within anvil channel136′ as compared to when adjustment member230′ is in its first position. In at least one embodiment, as a result, the first and second staple forming heights can be larger than the third staple forming height. In at least one such embodiment, the first position of adjustment member230′, and actuator250′, can represent an intermediate position, wherein adjustment member230′ can be selectively moved into its second and third positions directly from its first position. In effect, the first position of adjustment member230′ can represent an intermediate staple height, wherein the second and third staple positions of adjustment member230′ can represent taller and shorter staple heights, respectively. In certain embodiments, referring toFIG. 24, surgical stapling instrument100′ can include one or more indicia thereon which can be configured to convey the staple forming heights, or at least relative forming heights, that can be selected. For example, second handle portion104′ can include a first indicium245′ which can indicate an intermediate, or first, staple height, a second indicium246′ which can indicate a taller, or second, staple height, and, in addition, a third indicium247′ which can indicate a shorter, or third, staple height.

In various embodiments, further to the above, one or more of first surfaces231′, second surfaces232′, and third surfaces233′ can comprise or define, or at least partially comprise or define, a perimeter, or circumference, of adjustment member230′. As discussed above, owing to the first, second, and third diameters (241′,242′, and243′) defined by the first, second, and third surfaces (231′,232′, and233′), respectively, the perimeter, or circumference, of adjustment member230′ may be non-circular. In certain embodiments, though, the perimeter, or circumference of adjustment member230′, may be symmetrical, substantially symmetrical, and/or non-symmetrical. In various embodiments, further to the above, an adjustment member can comprise a cam rotatably positioned intermediate base138′ of anvil130′ and adjustment surface145′ of anvil plate134′, for example. In at least one such embodiment, one or more of first surfaces231′, second surfaces232′, and third surfaces233′, for example, can comprise or define a cam profile which, similar to the above, can be configured to either positively position anvil plate134′ and/or provide a stop against which anvil plate134′ can be positioned. In any event, although not illustrated, various embodiments are envisioned in which an adjustment member can be slid and rotated in order to set two or more staple forming heights for staples deployed by a surgical stapling instrument. In at least one such embodiment, an adjustment member can comprise a cam profile which can be defined along the length of the adjustment member wherein longitudinal and/or rotational movement can be utilized to move the cam profile between at least first and second positions.

In various embodiments, similar to the above, surgical instrument100′ can further include a detent mechanism configured to hold, or at least releasably hold, actuator250′ in position. In at least one embodiment, referring toFIGS. 25 and 26, surgical instrument100′ can further include detent member260′ comprising detent body261′ and one or more detent legs262′. Referring toFIG. 26, detent body261′ can include one or more grooves, recesses, or channels263′ which can be configured to receive at least a portion of proximal end105′ of second handle portion104′ therein such that detent member260′ can be retained in position. In at least one such embodiment, proximal end105′ can further include one or more grooves, channels, or recesses265′ which can be configured to closely receive detent member260′. In certain embodiments, at least a portion of detent body261′, such as channel263′, for example, can be press-fit, snap-fit, and/or otherwise suitably retained in recess265′. As also illustrated inFIG. 26, each detent leg262′ of detent member260′ can include one or more projections264′ extending therefrom which can be configured to engage actuator body251′ and releasably hold actuator250′ in position. In at least one embodiment, referring toFIG. 36, actuator body251′ can include one or more recesses, or holes,269′ which can be configured to receive a projection264′. When a projection264′ is positioned within recess269′, the projection can be configured to hold actuator250′ in its first position, for example, until a sufficient force is applied to actuator250′ so as to cause the projection264′ to be displaced out of recess269′. More particularly, the force applied to actuator250′ can be transmitted to the projection264′ and, owing to cooperating surfaces between the projection264′ and recess269′, the detent leg262′ associated with the projection264′ can be flexed or moved proximally to allow actuator body251′ to be moved relative thereto. In order to accommodate such proximal movement, referring toFIG. 25, recess265′ can include elongate portions266′ which can each be configured to receive at least a portion of legs262′ such that legs262′ can move relative to handle portion104′. As actuator250′ is moved into either its second or third position, actuator body251′ can contact a projection264′ extending from another leg262′ and deflect the leg262′ proximally such that, once actuator250′ is in its second or third positions, the leg262′ can spring forward, or distally, such that the projection264′ can be secured within recess269′. In at least one embodiment, further to the above, the interaction between projections264′ and the sidewalls of recess269′ can be such that actuator250′ can be securely held in one of its first, second, and third positions, for example, yet permit actuator250′ to be moved upon a sufficient application of force. In such embodiments, the detent member260′ can prevent, or at least inhibit, actuator250′ and, correspondingly, adjustment member230′ from being unintentionally displaced.

As discussed above and as shown inFIG. 2, each side flange128of first handle portion102can include a notch, or recess,127, for example, which can be configured to receive one or more latch projections131, for example, extending from anvil130, and/or any other suitable portion of second handle portion104. As also discussed above, referring primarily toFIGS. 2 and 3, first handle portion102can further include latching mechanism180rotatably mounted thereto which can be utilized to engage latch projections131extending from second handle portion104and secure the first and second handle portions102,104together. Latching mechanism180can include one or more latch arms188extending therefrom which can be configured to engage latch projections131and pull and/or secure projections131within recesses127as illustrated inFIG. 7. Referring toFIG. 6, at least one of latch arms188can include a distal hook189which can be configured to wrap around at least a portion of projections131so as to encompass or surround, or at least partially encompass or surround, projections131. In at least one embodiment, latch arms188can act as an over-center latch to maintain latching mechanism180in its latched, or closed, position.

In various embodiments, referring now toFIG. 38, each projection131can comprise a slot, or groove,190positioned intermediate sidewall191and an enlarged end, or head,192of projection131, wherein the slot190can be configured to receive at least a portion of latch arm188. More particularly, in at least one embodiment, the slot190can have a width which is greater than the width of the latch arm188such that, when the latch arm188is engaged with the projection131, the latch arm188can enter into slot190. In some circumstances, the width of each slot190may be slightly larger than the width of a latch arm188such that the latch arm is closely received within the slot190. In various circumstances, the slot190, the sidewall191, and the head192of projection131can be sized and configured so as to prevent, or at least limit, relative lateral movement, i.e., movement away from or to the sides of anvil130, between latch arm188and projection131. Further to the above, however, the latch arms188can slide longitudinally within the grooves190as the latch arms188move the projections131into the recesses127in first portion102. Owing to such relative sliding movement between latch arms188and projections131, frictional forces can be generated therebetween which can resist the movement of latch arms188. In various circumstances, the magnitude of such frictional forces can be significant when the normal, or perpendicular, contact forces between the latch arms188and the sidewalls of groove190are large. In many circumstances, as a result, the operator of the surgical instrument has to overcome these frictional forces when actuating clamping mechanism180.

In various alternative embodiments, referring now toFIGS. 39 and 40, a surgical instrument can comprise one or more latch projections having a rotatable bearing which can reduce the magnitude of the friction forces between the latch arms of a latching mechanism and the latch projections. In at least one embodiment, an anvil330, which can be substantially similar to anvil130in many respects, can comprise a latch projection331extending from each side thereof, wherein each latch projection331can comprise a rotatable bearing393. In use, the latch arms188of latching mechanism180, for example, can contact the rotatable bearings393in order to position the latch projections331in recesses127. In various circumstances, the latch arms188can slide across the surface, or outer diameter, of bearings393; however, as bearings393can rotate relative to the latch arms188, the magnitude of the frictional forces between the latch arms188and projections331can be lower than the magnitude of the frictional forces between latch arms188and projections131. Owing to such lower frictional forces, a lower closing, or clamping, force may be required to actuate clamping mechanism180, for example.

In various embodiments, referring primarily toFIG. 41, each rotatable bearing393can comprise a circular, or round, outer diameter394and, in addition, a circular, or round, bearing aperture395extending therethrough. In certain embodiments, each projection331can further comprise a shaft portion396extending from sidewall391and an enlarged end, or head,392extending from shaft portion396, wherein, as illustrated inFIG. 31, the shaft portion396can extend through the bearing aperture395of rotatable bearing393. In various embodiments, the shaft portion396can comprise a circular, or round, outer diameter which can be closely received within bearing aperture395such that there is little, if any, relative radial movement therebetween. The diameter of the bearing aperture395, however, may be sufficiently larger than the outer diameter of shaft portion396such that bearing393can rotate relative to shaft portion396about an axis399. In various embodiments, the rotatable bearing393can be retained on shaft portion396by the enlarged head392. More particularly, in at least one embodiment, the enlarged head392may be larger than, or define a larger diameter than, the diameter of bearing aperture395such that rotatable bearing393cannot slide off the end of shaft portion396. In certain embodiments, the sidewall391and the head392can define a gap distance therebetween and, in addition, the bearing393can comprise a width, wherein the gap distance can be larger than the width of bearing393. In at least one embodiment, the gap distance may be slightly larger than the width of bearing393such that bearing393does not tilt, or at least substantially tilt, relative to axis399, for example.

As discussed above, the latch arms188of latching mechanism180can be configured to engage bearings393and position bearings393within recesses127. In various alternative embodiments, referring primarily toFIG. 40, a surgical instrument can comprise a latching mechanism380which can comprise first and second latch arms388extending therefrom on opposite sides of anvil331and staple cartridge channel324. In use, similar to the above, the latch arms388can contact bearings393in order to move bearings393into recesses327in staple cartridge channel324and move anvil331toward staple cartridge channel324. Such movement is illustrated with phantom lines inFIG. 41. In various embodiments, each latch arm388can at least partially define a groove, or slot,397therein, wherein each slot397can be configured to receive a bearing393. In at least one embodiment, a slot397can comprise a first drive surface, or sidewall,398awhich can be positioned against bearing393and, as a closing force is applied to latching mechanism380, the latch arm388can apply a closing force to the bearing393. In such circumstances, the bearing393can move further into slot397as latching mechanism380is rotated into its closed position. In various circumstances, the slot397can further comprise a second drive surface, or sidewall,398bwhich can be positioned against another and/or opposite side of bearing393such that an opening force can be applied to the bearing393via latch arm388. As the latching mechanism380is moved into its open position, the bearing393can move out of slot397. In any event, the first drive surface398aand the second drive surface398bcan define a slot width therebetween which can be larger than the outside diameter of bearing393such that bearing393can move within slot397. In some embodiments, the slot width may be slightly larger than the outside diameter of bearing393. In at least one embodiment, at least portions of the first drive surface398aand the second drive surface398bcan be parallel, or at least substantially parallel, to one another. In at least one such embodiment, at least portions of the first drive surface398acan be positioned opposite the second drive surface398b.

As described above, a surgical stapling instrument can be configured to deform one or more surgical staples between a first, undeployed, configuration and a second, deployed, configuration. In various embodiments, referring now toFIG. 39, a surgical staple, such as staple400, for example, can comprise a base402, a first leg, or deformable member,404extending from base402, and, in addition, a second leg, or deformable member,406extending from base402. In certain embodiments, the base402, the first leg404, and the second leg406can be comprised of a continuous wire, wherein, in at least one embodiment, the first leg404and the second leg406can each be bent in a direction which is perpendicular to the base402prior to staple400being inserted into and deformed by a surgical stapler. More particularly, the staple400can be manufactured such that base402is oriented along a baseline401and such that the legs404and406are oriented along lines409and411, respectively, which are perpendicular, or at least substantially perpendicular, to the baseline401. In various embodiments, the first leg404can be positioned at a first end of base402and the second end406can be positioned at a second end of base402, wherein, in at least one embodiment, a mid-line403can be defined which extends through a midpoint of base402and which extends in a direction which is perpendicular to baseline401. The staple400can be configured such that the base402, first leg404, and second leg406lie, or at least substantially lie, in the same, or common, plane when the staple400is in its first, or undeployed, configuration. In such embodiments, the baseline401, along which the base402is oriented, and the perpendicular lines409and411, along which the legs404and406are oriented, can lie in the same plane.

In various embodiments, further to the above, the continuous wire comprising the base402, the first leg404, and the second leg406can be comprised of titanium and/or stainless steel, for example. In at least one embodiment, the first leg404can comprise a first end405and the second leg406can comprise a second end407, wherein the ends405and407can each comprise a sharp, or chisel, tip which can be configured to puncture bone and/or tissue. In use, the staple400can be deformed by a surgical stapler in order to capture tissue, for example, within the staple400. In various embodiments, the staple400can be deployed from a staple cartridge such that the ends405and407of staple legs404and406, respectively, contact an anvil positioned opposite the staple400. In such circumstances, a first compressive force F1can be applied to the first leg404and a second compressive force F2can be applied to the second leg406while the base402is supported by at least a portion of the staple cartridge. As described in greater detail below, the anvil can comprise a staple pocket which can apply the first compressive force F1to the first leg404such that the end405of staple leg404is moved toward the base402. Similarly, the staple pocket can apply the second compressive force F2to the second staple leg406such that the end407of staple leg404is also moved toward base402. In addition to the above, as also discussed in greater detail below, referring now toFIGS. 50-52, the staple pocket can bend the first staple leg404to a first side of base402and the second staple leg406to a second, or opposite, side of base402.

In various embodiments, referring toFIGS. 49 and 50, the first leg404of staple400can be bent such that the end405of the first leg404is moved toward the base402and toward the second leg406when the first leg404is deformed by the first compressive force F1. In at least one embodiment, the end405can be moved from a first side410of midline403, as illustrated inFIG. 49, to a second side412of midline403, as illustrated inFIG. 50. Similarly, the second leg406of staple400can be bent such that the end407of the second leg406is moved toward the base402and toward the first leg404when the second leg406is deformed by the second compressive force F2. In at least one embodiment, the end407can be moved from a second side412of midline403, as illustrated inFIG. 49, to a first side410of midline403, as illustrated inFIG. 50. In the deployed, or deformed, configuration of staple400, as illustrated inFIG. 50, the ends405and407of staple legs404and406can extend across the midline403in such a way that they form an angle therebetween. More particularly, the end405of the first leg404, when it is in its deformed configuration, can extend along or with respect to a first axis414and, similarly, the end407of the second leg406, when it is in its deformed configuration, can extend along or with respect to a second axis416such that the first axis414and the second axis416define an angle417therebetween. In some embodiments, the angle417may be approximately 90 degrees, for example. In certain embodiments, the angle417may be in a range between approximately 0.1 degrees and approximately 89 degrees, for example. In various embodiments, the angle417may be greater than 90 degrees, while, in at least one embodiment, the angle417may be greater than approximately 90 degrees but less than 180 degrees, for example.

In various embodiments, further to the above, the first axis414and the second axis416can, in various embodiments, be oriented, or crossed, at a transverse angle with respect to each other, i.e., at least when the staple400is viewed from the side or elevational view ofFIG. 50. More particularly, upon reviewingFIG. 52, it becomes evident that, although axes414and416extend in transverse directions when viewed from the side (FIG. 50), the axes414and416may not, in at least one embodiment, actually intersect one another. In such embodiments, when viewing the staple400from the top or bottom (FIG. 52), for example, the axes414and416may extend in parallel, or at least substantially parallel, directions. Furthermore, in various embodiments, the reader will note that the first axis414and the second axis416are not perpendicular with baseline401. Stated another way, the end405of first staple leg404and the end407of second staple leg406are not pointing directly downwardly toward base402and baseline401. In at least one such embodiment, the first axis414and the second axis416can each extend at an acute angle with respect to baseline401, for example.

As described above, a surgical instrument can be configured to deform the staple400ofFIG. 49, for example, between an undeformed shape (FIG. 49) and a deformed shape (FIG. 50). In various embodiments, as also described above, the surgical instrument can comprise an anvil having a staple pocket configured to receive and deform at least a portion of the staple. In certain embodiments, referring now toFIG. 42, an anvil can comprise a tissue-contacting surface501and a plurality of staple pockets500formed therein, wherein each staple pocket500can be configured to deform a staple400. In various embodiments, each staple pocket500can comprise a longitudinal axis599(FIG. 43) and, in addition, a first forming cup502and a second forming cup504positioned relative to the longitudinal axis599. In use, the first forming cup502can be configured to receive the first staple leg404of staple400and the second forming cup504can be configured to receive the second staple leg406. More particularly, in at least one embodiment, the staple pocket500can be positioned relative to the staple400such that, as the staple400is ejected from a staple cartridge, for example, the end405of first leg404can enter the first forming cup502and the end407of second leg406can enter the second forming cup504. Further to the above, the end405of first staple leg404can contact the base506of first forming cup502such that the first compressive force F1can be applied to the first leg404and, similarly, the end407of second staple leg406can contact the base508of second forming cup504such that the second compressive force F2can be applied to the second leg406.

In various embodiments, further to the above, the first forming cup502can comprise an inside portion510and an outside portion512, wherein, when the end405of first staple leg404enters into the first forming cup502, the end405can enter into the outside portion512. Upon entering into the outside portion512of forming cup502, the end405can contact base506and, owing to a concave curve of base506, the end405can be directed inwardly toward the inside portion510. More particularly, referring now toFIGS. 46-48, the base506can be curved toward tissue-contacting surface501such that, as the staple leg404contacts the base506, the end405can be directed downwardly, i.e., away from tissue-contacting surface501, and inwardly along the curved concave surface toward an inflection point595. In various embodiments, the inflection point595can represent the point in which the concave surface of base506will begin to deflect the end405of first leg404upwardly toward the tissue-contacting surface501. In various embodiments, the radius of curvature, r, of the concave surface can be constant, or at least substantially constant, in the longitudinal direction along the length thereof as illustrated inFIGS. 47 and 48. In certain embodiments, the radius of curvature r of the concave surface of base506can be consistent across the width of base506between a first interior sidewall516and a first exterior sidewall517. In any event, as the end405of first leg404is advanced into the inside portion510of forming cup502, the end405can come into contact with a radius transition514positioned intermediate the base506and the first interior sidewall516. In such embodiments, the radius transition514can be configured to direct the end405against the first interior sidewall516.

As illustrated inFIG. 43, further to the above, the first interior sidewall516can be oriented at an angle with respect to staple pocket longitudinal axis599. In certain embodiments, the first interior sidewall516can be oriented at an acute angle, such as 10 degrees, for example, with respect to longitudinal axis599. In various embodiments, the first interior sidewall516and the longitudinal axis599may be neither perpendicular nor parallel to one another. In any event, the first interior sidewall516can extend through the axis599such that a first portion of the first interior sidewall516is positioned on a first side515of axis599and a second portion of the first interior sidewall516is positioned on a second side517of axis599. In various embodiments, as a result, the first interior sidewall516can extend between the first outside portion512and the first inside portion510. When the end405of first leg404contacts the first interior sidewall516, as described above, the end405can be directed along the first interior sidewall516and away from longitudinal axis599such that the staple leg404is bent away from the common plane of staple400toward the first side515of axis599. As the end405of first leg404is directed along, or bent by, the first interior sidewall516, as described above, the staple leg404can also be directed, or bent, by base506. Stated another way, the first sidewall516and the first base506can co-operate to deform the first staple leg404such that end405is re-directed toward the base402and, at the same time, to a first side of the base402as described above. At some point during the insertion of first staple leg404into first forming cup502, the end405of first staple leg404can emerge from the first inside portion510of first forming cup502and, as the staple leg404is further deformed by the staple pocket500, the end405can be directed along the first axis414(FIG. 50) as described above.

In various embodiments, further to the above, the first interior sidewall516can extend along an interior side of the first base506, wherein, in at least one embodiment, the first forming cup502can further comprise a first exterior sidewall517extending along an opposite side of the first base506. In certain embodiments, similar to the above, the first forming cup502can further comprise a transition radius519positioned intermediate the base506and the exterior sidewall517. In at least one embodiment, referring now toFIG. 43, the exterior sidewall517can extend in a direction which is parallel, or at least substantially parallel, to the staple pocket longitudinal axis599. As also illustrated inFIG. 43, the first interior sidewall516and the first exterior sidewall517can extend in directions which are transverse to one another. In at least one embodiment, the interior sidewall516can extend at an acute angle, such as approximately 15 degrees, for example, with respect to the exterior sidewall517. In various embodiments, as a result, the outside portion512of first forming cup502can be wider than the inside portion510. In at least one such embodiment, the width of the outside portion512and the inside portion510can taper between a first width and a second width.

In various embodiments, referring once again toFIG. 43, the outside portion512of first forming cup502can comprise a first outside wall513which can extend in a direction which is perpendicular to the first exterior wall517and/or the longitudinal axis599and can define the outermost portion of forming cup502. In at least one embodiment, further to the above, the width of the first outside wall513can be such that the outside portion512can capture the end405of first leg404and guide it into the inside portion510of cup502as described above. In at least one such embodiment, the first outside wall513can be at least as twice as wide as the diameter of the first leg404. In certain embodiments, the first forming cup502can further comprise a channeling surface528surrounding the first inner portion510and the first outer portion512which can be configured to guide the staple leg404into and/or out of the forming cup502. In various embodiments, the inside portion510can further comprise an inside wall511which can define the innermost portion of forming cup502. Similar to the above, the inside wall511can also define the narrowest portion of forming cup502. In at least one embodiment, the width of the inside wall511may be the same, or at least substantially the same, as the diameter of first leg404such that the inside wall511can control the location in which the end405emerges from staple forming cup502.

In various embodiments, further to the above, the second forming cup504can comprise an inside portion520and an outside portion522, wherein, when the end407of second staple leg406enters into the second forming cup504, the end407can enter into the outside portion522. Upon entering into the outside portion522of forming cup504, the end407can contact base508and, owing to a concave curve of base508, the end407can be directed inwardly toward the inside portion520. More particularly, similar to the above, the base508can be curved toward tissue-contacting surface501such that, as the staple leg406contacts the base508, the end407can be directed downwardly, i.e., away from tissue-contacting surface501, and inwardly along the curved concave surface toward an inflection point596. In various embodiments, the inflection point596can represent the point in which the concave surface of base508will begin to deflect the end407of second leg406upwardly toward the tissue-contacting surface501. In various embodiments, the radius of curvature, r, of the concave surface can be constant, or at least substantially constant, in the longitudinal direction along the length thereof, similar to the base506of first forming cup502illustrated inFIGS. 47 and 48. In any event, as the end407of second leg406is advanced into the inside portion520of forming cup504, the end407can come into contact with a radius transition524positioned intermediate the base508and a second interior sidewall526. In such embodiments, the radius transition524can be configured to direct the end407against the second interior sidewall526.

As illustrated inFIG. 43, further to the above, the second interior sidewall526can be oriented at an angle with respect to staple pocket longitudinal axis599. In certain embodiments, the second interior sidewall526can be oriented at an acute angle, such as 10 degrees, for example, with respect to longitudinal axis599. In various embodiments, the second interior sidewall526and the longitudinal axis599may be neither perpendicular nor parallel to one another. In any event, the second interior sidewall526can extend through the axis599such that a first portion of the second interior sidewall526is positioned on a first side515of axis599and a second portion of the second interior sidewall526is positioned on a second side517of axis599. In various embodiments, as a result, the second interior sidewall526can extend between the second outside portion522and the second inside portion520. When the end407of second leg406contacts the interior sidewall526, as described above, the end407can be directed along the interior sidewall526such that the staple leg406is bent away from the common plane of staple400toward the second side517of axis599. As the end407of second leg406is directed along, and bent by, the interior sidewall526, as described above, the staple leg406can also be directed, and bent, by base508. Stated another way, the second interior sidewall526and the second base508can co-operate to deform the second staple leg406such that end407is re-directed toward the base402and, at the same time, toward a second, or opposite, side of the base402as described above. At some point during the insertion of second staple leg406into second forming cup504, the end407of second staple leg406can emerge from the second inside portion520of second forming cup504and, as the staple leg406is further deformed by the staple pocket500, the end407can be directed along the second axis416(FIG. 50) as described above.

In various embodiments, further to the above, the second interior sidewall526can extend along an interior side of the second base508, wherein, in at least one embodiment, the second forming cup504can further comprise a second exterior sidewall527extending along an opposite side of the second base508. In certain embodiments, similar to the above, the second forming cup504can further comprise a transition radius529positioned intermediate the base508and the exterior sidewall527. In at least one embodiment, referring now toFIG. 43, the exterior sidewall527can extend in a direction which is parallel, or at least substantially parallel, to the staple pocket longitudinal axis599. As also illustrated inFIG. 43, the second interior sidewall526and the second exterior sidewall527can extend in directions which are transverse to one another. In at least one embodiment, the interior sidewall526can extend at an acute angle, such as approximately 15 degrees, for example, with respect to the exterior sidewall527. In various embodiments, as a result, the outside portion522of second forming cup504can be wider than the inside portion520. In at least one such embodiment, the width of the outside portion522and the inside portion520can taper between a first width and a second width.

In various embodiments, referring once again toFIG. 43, the outside portion522of second forming cup504can comprise a second outside wall523which can extend in a direction which is perpendicular to the second exterior wall527and/or the longitudinal axis599and can define the outermost portion of forming cup504. In at least one embodiment, further to the above, the width of the second outside wall523can be such that the outside portion522can capture the end407of second leg406and guide it into the inside portion520of cup504as described above. In at least one such embodiment, the second outside wall523can be at least as twice as wide as the diameter of the second leg406. In certain embodiments, the second forming cup504can further comprise a channeling surface529surrounding the second inner portion520and the second outer portion522which can be configured to guide the staple leg406into and/or out of the forming cup504. In various embodiments, the inside portion520can further comprise an inside wall521which can define the innermost portion of forming cup504. Similar to the above, the inside wall521can also define the narrowest portion of forming cup504. In at least one embodiment, the width of the inside wall521may be the same, or at least substantially the same, as the diameter of second leg406such that the inside wall521can control the location in which the end407emerges from staple forming cup504.

As discussed above, referring again toFIGS. 43-45, the first forming cup502can comprise a first interior sidewall516and the second forming cup504can comprise a second interior sidewall526. As illustrated inFIG. 43, the first inside portion510of forming cup502can be positioned in close proximity to, or close relation to, the second inside portion520of forming cup504such that the first interior sidewall516can be positioned adjacent to the second interior sidewall526. In at least one embodiment, the first interior portion510, or at least a substantial portion thereof, can be offset from the staple pocket longitudinal axis599in the first direction515while the second interior portion520, or at least a substantial portion thereof, can be offset from the longitudinal axis599in the second direction517. In various embodiments, the staple pocket500can comprise a wall530positioned intermediate the first inside portion510and the second inside portion520, wherein a first side of wall530can comprise the first interior sidewall516and wherein a second side of wall530can comprise the second interior sidewall526. In at least one such embodiment, the first interior sidewall516can be parallel, or at least substantially parallel to, the second interior sidewall526. More particularly, in at least one embodiment, the first interior sidewall516can define a first plane and the second interior sidewall526can define a second plane, wherein the first plane and the second plane can be parallel, or at least substantially parallel, to one another. In various embodiments, referring again toFIGS. 44 and 45, the first interior sidewall516can be perpendicular, or at least substantially perpendicular, to the tissue-contacting surface501and, similarly, the second interior sidewall526can be perpendicular, or at least substantially perpendicular, to the tissue-contacting surface501.

In various embodiments, further to the above, the first interior sidewall516can comprise a first vertical portion516awhich is perpendicular, or at least substantially perpendicular, to the tissue-contacting surface501. In at least one embodiment, the first vertical portion516acan extend through, or transect, the longitudinal axis599. In various embodiments, the first vertical portion516acan extend along the entirety of, or only a portion of, the first interior sidewall516. Similarly, the second interior sidewall526can comprise a second vertical portion526awhich is perpendicular, or at least substantially perpendicular, to the tissue-contacting surface501. In at least one embodiment, such a second vertical portion526acan extend through, or transect, the longitudinal axis599. In various embodiments, the second vertical portion526acan extend along the entirety of, or only a portion of, the second interior sidewall526. During the deployment of staple400, further to the above, the end405of first leg404can be in contact with the first vertical portion516aof first interior sidewall516at the same time the end407of second leg406is in contact with the second vertical portion526aof second interior sidewall526. In such circumstances, the first vertical portion516aand the second vertical portion526acan comprise a vertical trap. More particularly, the vertical portions516aand526acan co-operate to control, deflect, and bend the staple legs404and406in opposite directions, i.e., in directions to the sides of a common plane, as described above, when the legs404and406come into contact with the interior sidewalls516and526of forming cups502and504, respectively. For example, referring again toFIG. 52, the first vertical portion516acan be configured to deflect and bend the staple leg404to a first side of base402and the second vertical portion526acan be configured to deflect and bend the staple leg406to a second, or opposite, side of base402.

In various embodiments, further to the above, the vertical trap comprising vertical portions516aand526acan extend along the entire length of the first and second interior sidewalls516and526, while, in other embodiments, the vertical trap may extend along only a portion of the sidewalls516and526. In at least one embodiment, the vertical trap can be approximately 0.05 inches long, i.e., the overlap of the first vertical surface516aand the second vertical surface526acan be approximately 0.05 inches, for example, along the lengths of interior surfaces516and526. In various embodiments, the length of the vertical trap can be between approximately 0.03 inches and approximately 0.10 inches, for example. In certain embodiments, the length of the vertical trap can be approximately twice the radius of curvature (r) of the curved concave surface of base506, for example. In various embodiments, the length of the vertical trap can be approximately equal to the radius of curvature (r) of base506, for example. In at least one embodiment, the length of the vertical trap can be between approximately 0.5*r and approximately 2*r, for example. In various embodiments, further to the above, the vertical trap can extend through the longitudinal axis599of staple pocket500such that, in at least one embodiment, at least a portion of the vertical trap can be positioned on a first side and/or a second side of axis599. In certain embodiments, the vertical trap can extend through the central portions of the first and second forming cups502and504.

In various embodiments, the first interior sidewall516can further comprise a first angled portion which, in at least one embodiment, can be oriented at an acute angle with respect to the tissue-contacting surface501. In at least one such embodiment, the first angled portion can be positioned outwardly with respect to the first vertical portion516a. In certain embodiments, the first interior sidewall516can comprise an angled portion positioned toward the outside portion512which can become progressively more perpendicular toward the inside portion510of the first forming cup502until the angled portion transitions into the first vertical portion516a. In various embodiments, the second interior sidewall526can further comprise a second angled portion which, in at least one embodiment, can be oriented at an acute angle with respect to the tissue-contacting surface501. In at least one such embodiment, the second angled portion can be positioned outwardly with respect to the second vertical portion526a. In certain embodiments, the second interior sidewall526can comprise an angled portion positioned toward the outside portion522which can become progressively more perpendicular toward the inside portion520of the second forming cup504until the angled portion transitions into the second vertical portion526a.

In various embodiments, referring now toFIG. 52A, the staple pocket500can be configured to deform the first staple leg404such that the first end405is deflected a first distance X1from baseline401. Similarly, the second staple leg406can be deformed such that the second end407is deflected a second distance X2from baseline401. In certain embodiments, the distance X1and the distance X2can be the same, or at least substantially the same. In various other embodiments, the distances X1and X2can be different. In at least one such embodiment, the first leg404can be deformed such that the first end405is positioned closer to base402than the second end407, for example. In such embodiments, the first axis414of deformed staple leg404and the second axis416of deformed staple leg406may be non-parallel. More particularly, in at least one embodiment, the first axis414can extend at a first angle with respect to baseline401and the second axis416can extend at a second angle with respect to baseline401wherein the second angle is different than the first angle. In various embodiments, the first leg404and the second leg406can extend across midline403at different angles. In certain other embodiments, the first leg404and the second leg406can be extend at different angles with respect to baseline401although one or both of the legs404and406may not extend across the midline403.

In various embodiments, further to the above, a surgical stapler can comprise a staple pocket which can be configured to deform one staple leg of staple400such that it lies within, or substantially within, a common plane with base402and, in addition, deform the other staple leg of staple400to a side of base402as described above. In at least one embodiment, the first leg404can be deformed such that it extends through midline403in a direction which is co-planar, or at least substantially co-planar, with base402and, in addition, the second leg406can be deformed such that it extends through midline403in a direction which is transverse to the plane. Stated another way, in at least one embodiment, axis414and baseline401of staple400can be coplanar, or at least nearly co-planar, with one another while second axis416can extend in a direction which extends through such a plane. In certain embodiments, at least one of the first leg404and the second leg406may not extend through the midline403.

In various embodiments, further to the above, the staple pocket500can be configured to deform the staple legs404and406of staple400simultaneously, or at least substantially simultaneously. In at least one embodiment, the base506of first forming cup502can contact end405of first staple leg404at the same time, or at least substantially the same time, that the base508of second forming cup504contacts end407of second staple leg406. In certain other embodiments, a staple pocket can be configured to deform the staple legs404and406sequentially. In at least one such embodiment, a first forming cup can be brought into contact with the first staple leg404before a second forming cup is brought into contact with the second staple leg406, for example. In various alternative embodiments, although not illustrated, a surgical staple can comprise more than two staple legs, such as three staple legs or four staple legs, for example, and a staple pocket can comprise a corresponding quantity of staple forming cups for deforming the staple legs.

In various embodiments, further to the above, the wire comprising the surgical staple400can comprise a circular, or at least substantially circular, cross-section. In various other embodiments, referring now toFIGS. 53-56, a surgical staple, such as staple600, for example, can comprise a non-circular cross-section. In at least one embodiment, the staple600can comprise a base602, a first leg604, and a second leg606, wherein the base602and legs604and606can be comprised of a continuous wire. In various embodiments, the continuous wire can comprise a rectangular cross-section, for example. In at least one embodiment, referring toFIG. 56, the rectangular cross-section can comprise a base (b) and a height (h), wherein the base (b) can be defined relative to a central lateral axis (x), and wherein the height (h) can be defined relative to a central longitudinal axis (y). In various circumstances, the rectangular cross-section can be defined as having two moments of inertia, i.e., a first moment of inertia (Ix) defined with respect to axis (x) and a second moment of inertia (Iy) defined with respect to axis (y). In at least one circumstance, the first moment of inertia (Ix) can be calculated as (b*h^3)/12 while the second moment of inertia (Iy) can be calculated as (h*b^3)/12. Although staple600comprises a rectangular, or at least substantially rectangular cross-section, any other suitable non-circular cross-section can be utilized, such as oblate, elliptical, and/or trapezoidal cross-sections, for example.

As illustrated inFIG. 56, the base (b) of surgical staple600is larger than the height (h) and, in view of the above, the moment of inertia (Iy) of the rectangular cross-section is larger than the moment of inertia (Ix). In various embodiments, as a result, the moment of inertia ratio, i.e., Iy/Ix, of the rectangular cross-section can be greater than 1.0. In certain embodiments, the moment of inertia ratio can be between approximately 2.0 and approximately 2.7, for example. In certain other embodiments, the moment of inertia ratio can be between approximately 1.1 and approximately 3.0, for example. As a result of the above, the leg604is more likely to bend about axis (x) than about axis (y) when a force, such as compressive load F1, for example, is applied to the leg604. In any event, absent all other considerations, the leg604, in such embodiments, is more likely to bend within a common plane defined by the staple600when it is in its undeformed state than bend to a side of staple base602. In various embodiments, however, a surgical stapler comprising an anvil and staple pocket in accordance with the embodiments described herein, such as staple pocket500, for example, can be utilized to cause the legs604and606of staple600to bend out of their common plane when they are deformed. In such embodiments, this lateral deflection can occur despite the fact that the moment of inertia Iy, which resists such twisting, is greater than the moment of inertia1x. As illustrated inFIG. 55, the first leg604of staple600can be deformed such that it is bent relative to both axis (x) and axis (y) of its cross-section and, as a result, the first staple leg604can be twisted or deformed such that the end605of first staple leg604is positioned on a first side of base602. Similarly, the second leg606can be deformed such that it is bent relative to both axis (x) and axis (y) of its cross-section and, as a result, the second staple leg606can be twisted or deformed such that the end607of second staple leg606is positioned on a second side of base602.

In various embodiments, referring now toFIG. 57, a surgical staple, such as surgical staple700, for example, can comprise a base702and, in addition, a first leg704and a second leg706extending from base702. In certain embodiments, similar to the above, the base702, the first leg704, and the second leg706can lie, or at least substantially lie, in a common plane when the staple700is an undeformed, or undeployed, configuration, i.e., a configuration prior to being deformed by an anvil of a surgical stapler, for example. In the deformed or deployed configuration of staple700, as illustrated inFIG. 57, the first leg704can be deformed such that end705points toward base702and second leg706. More particularly, in at least one embodiment, the end705can lie along, or with respect to, a first axis714which is oriented at angle with respect to midline703. Similarly, the second leg706can be deformed such that end707points toward base702and first leg704. More particularly, in at least one embodiment, the end707can lie along, or with respect to, a second axis716which is oriented at angle with respect to midline703. In various embodiments, the ends705and707of legs704and706may not cross mid-line703. In certain embodiments, similar to the above, the end705of first leg704may be deformed such that it extends to a first side of base702and the end707of second leg706may be deformed such that it extends to a second, or opposite, side of base702such that legs704and706are not entirely positioned in-plane with base702in their deformed configuration, for example.

In various embodiments, a surgical staple, such as staple800(FIG. 58), for example, can comprise a base802, a first leg804, and a second leg806, wherein the staple800can comprise a substantially U-shaped configuration in its undeformed, or undeployed, configuration. In at least one such embodiment, legs804and806can extend in a perpendicular, or at least substantially perpendicular, direction with respect to base802. In various circumstances, the staple800can be deformed into a B-shaped configuration as illustrated inFIG. 58. In at least one such embodiment, the first leg804can be bent downwardly toward base802such that axis814extending through end805is perpendicular, or at least substantially perpendicular, to baseline801. Similarly, the second leg806can be bent downwardly toward base802such that axis816extending through end807is perpendicular, or at least substantially perpendicular, to baseline801. In at least one such circumstance, the legs804and806can be bent such that axes814and816are parallel, or at least substantially parallel, to one another. In various embodiments, referring again toFIG. 58, the staple legs804and806can be deformed such that they do not cross centerline803. The staple legs804and806can be deformed such that they remain in-plane, or at least substantially in-plane, with base802.

Various examples described below are envisioned which incorporate one or more aspects of the various embodiments described above. Such examples are exemplary and various aspects of various embodiments described in this application can be combined in a single embodiment. In each of the examples described below, the surgical staple can comprise a base defining a baseline, a first leg and a second leg which extend from the base, and a midline midway between the first leg and the second leg.

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Crosses the midline (FIG. 50)Extends in-plane, or substantially in-Extends out of plane with theplane, with the base (FIG. 58)base (FIG. 52)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Crosses the midline (FIG. 50)Extends out of plane with theExtends out of plane with thebase (FIG. 52) to the same sidebase (FIG. 52) to the same sideof the base as the second leg,of the base as the first leg,the distance X1 being differentthe distance X1 being differentthan X2 (FIG. 52A)than X2 (FIG. 52A)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegDoes not cross the midlineDoes not cross the midline(FIG. 57)(FIG. 57)Extends out of plane with theExtends out of plane with thebase (FIG. 52) to a first sidebase (FIG. 52) to a second sideof the base, the distance X1of the base, the distance X1being different than X2 (FIG. 52A)being different than X2 (FIG. 52A)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegDoes not cross the midlineDoes not cross the midline(FIG. 57)(FIG. 57)Extends out of plane with theExtends out of plane with thebase (FIG. 52) to the same sidebase (FIG. 52) to the same sideof the base as the second leg,of the base as the second leg,the distance X1 being differentthe distance X1 being differentthan X2 (FIG. 52A)than X2 (FIG. 52A)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegDoes not cross the midlineDoes not cross the midline(FIG. 57)(FIG. 57)Extends in-plane, or substantially in-Extends out of plane with theplane, with the base (FIG. 58)base (FIG. 52)The end extends in a perpendicularThe end extends in a non-direction with the baseline (FIG. 58)perpendicular direction with thebaseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Does not cross the midline (FIG. 57)Extends out of plane with theExtends out of plane with thebase (FIG. 52) to a first sidebase (FIG. 52) to a second sideof the base, the distance X1of the base, the distance X1being different than X2 (FIG. 52A)being different than X2 (FIG. 52A)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Does not cross the midline (FIG. 57)Extends out of plane with theExtends out of plane with thebase (FIG. 52) to the same sidebase (FIG. 52) to the same sideof the base as the second leg,of the base as the second leg,the distance X1 being differentthe distance X1 being differentthan X2 (FIG. 52A)than X2 (FIG. 52A)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Does not cross the midline (FIG. 57)Extends out of plane with theExtends in-plane, or substantially in-base (FIG. 52)plane, with the base (FIG. 58)The end extends in a non-The end extends in a perpendicularperpendicular direction with thedirection to the baseline (FIG. 58)baseline (FIG. 50)

A surgical staple can be deformed such that:

First LegSecond LegCrosses the midline (FIG. 50)Does not cross the midline (FIG. 57)Extends in-plane, or substantiallyExtends out of plane with thein-plane, with the base (FIG. 58)base (FIG. 52)The end extends in a non-The end extends in a non-perpendicular direction with theperpendicular direction with thebaseline (FIG. 50)baseline (FIG. 50)

Several of the deformed staples described above comprise one or more staple legs which cross the mid-line of the staple base. In various embodiments, as a result, the deformed staple legs may at least partially overlap with one another. More particularly, the deformed staple legs, when viewed from the side, may co-operate to traverse the staple base from one end to the other leaving no gap therebetween. Such embodiments can be particularly useful, especially when used to staple vascular tissue. More specifically, the overlapping staple legs can compress blood vessels within the tissue regardless of where the blood vessels extend through the staple. Staples having gaps between the legs, or legs which do not extend along the entire length of the staple base when deformed, may not be able to properly compress every blood vessel in the tissue and, as a result, one or more blood vessels may leak.

In various embodiments, further to the above, a surgical instrument can be configured to deploy a plurality of staples400in the manner described above and illustrated inFIGS. 50-52. In at least one such embodiment, the surgical stapler can deploy the staples400in a sequential manner along a staple path and/or in a simultaneous manner, for example. In certain embodiments, a surgical instrument can be configured to deploy a plurality of staples600in the manner described above and illustrated inFIG. 55. In at least one such embodiment, similar to the above, the surgical stapler can deploy the staples600in a sequential manner along a staple path and/or in a simultaneous manner, for example. In various embodiments, further to the above, a surgical instrument can be configured to deploy a plurality of staples700in the manner described above and illustrated inFIG. 57. In at least one such embodiment, the surgical stapler can deploy the staples700in a sequential manner along a staple path and/or in a simultaneous manner, for example.

In various embodiments, further to the above, a surgical staple can be comprised of titanium, such as titanium wire, for example. In certain embodiments, a surgical staple can be comprised of an alloy comprising titanium, aluminum, and/or vanadium, for example. In at least one embodiment, the surgical staple can be comprised of surgical stainless steel and/or an alloy comprised of cobalt and chromium, for example. In any event, the surgical staple can be comprised of metal, such as titanium, and a metal oxide outer surface, such as titanium oxide, for example. In various embodiments, the metal oxide outer surface can be coated with a material. In certain embodiments, the coating material can be comprised of polytetrafluoroethylene (PTFE), such as Teflon®, and/or a tetrafluoroethylene (TFE) such as ethylene-tetrafluoroethylene (ETFE), perfluoroalkoxyethylene-tetrafluoroethylene (PFA), and/or Fluorinated Ethylene Propylene (FEP), for example. Certain coatings can comprise silicon. In various embodiments, such coating materials can prevent, or at least inhibit, further oxidation of the metal. In certain embodiments, the coating materials can provide one or more lubricious surfaces against which the anvil, or staple pockets, can contact the staples in order to reduce the friction force therebetween. In various circumstances, lower friction forces between the staples and the staple pockets can reduce the force required to deform the staples.