Articulatable surgical instrument system

[0001] The present invention relates to stapling instruments and, in various embodiments, to a surgical stapling instrument for producing one or more rows of staples.

[0002] A stapling instrument can include a pair of cooperating elongate jaw members, wherein each jaw member can be adapted to be inserted into a patient and positioned relative to tissue that is to be stapled and/or incised. In various embodiments, one of the jaw members can support a staple cartridge with at least two laterally spaced rows of staples contained therein, 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 a knife blade which are slidable relative to the jaw members to sequentially eject the staples from the staple cartridge via camming surfaces on the pusher bar and/or camming surfaces on a wedge sled that is pushed by 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 staples in order to push the staples against the anvil and form laterally spaced rows of deformed staples in the tissue gripped between the jaw members. In at least one embodiment, the knife blade can trail the camming surfaces and cut the tissue along a line between the staple rows. Examples of such stapling instruments are disclosed in U.S. Pat. No. 7,794,475, entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, the entire disclosure of which is hereby incorporated by reference herein.

[0003] The foregoing discussion is intended only to illustrate various aspects of the related art in the field of the invention at the time, and should not be taken as a disavowal of claim scope.

[0033] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate various embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

[0034] Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and illustrative. Variations and changes thereto may be made without departing from the scope of the claims.

[0035] The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a surgical system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of a system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.

[0036] The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

[0037] Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device that has a working channel through which the end effector and elongated shaft of a surgical instrument can be advanced.

[0038] A surgical stapling system 100 is depicted in FIGS. 1-7. Referring primarily to FIG. 1, the surgical stapling system 100 comprises a shaft 120 and an end effector 110 extending from the shaft 120. The end effector 110 comprises a first jaw 112 and a second jaw 114. The first jaw 112 comprises a staple cartridge 140. The staple cartridge 140 is insertable into and removable from the first jaw 112; however, other embodiments are envisioned in which a staple cartridge is not removable from, or at least readily replaceable from, the first jaw 112. The second jaw 114 comprises an anvil 130 configured to deform staples ejected from the staple cartridge 140. The second jaw 114 is pivotable relative to the first jaw 112 about a closure axis 131; however, other embodiments are envisioned in which first jaw 112 is pivotable relative to the second jaw 114. The surgical stapling system 100 further comprises an articulation joint 150 configured to permit the end effector 110 to be rotated, or articulated, relative to the shaft 120. The end effector 110 is rotatable about an articulation axis 151 extending through the articulation joint 150. The articulation axis 151 is orthogonal to a longitudinal axis 121 of the shaft 120 and a longitudinal axis 111 of the end effector 110.

[0039] Referring primarily to FIG. 2, the staple cartridge 140 comprises a cartridge body 142. The cartridge body 142 includes a proximal end 148, a distal end 149, and a deck 141 extending between the proximal end 148 and the distal end 149. In use, the staple cartridge 140 is positioned on a first side of the tissue to be stapled and the anvil 130 is positioned on a second side of the tissue. The anvil 130 is moved toward the staple cartridge 140 to compress and clamp the tissue against the deck 141. Thereafter, staples removably stored in the cartridge body 142 can be deployed into the tissue. The cartridge body 142 includes staple cavities 145 defined therein wherein staples 185 (FIG. 10) are removably stored in the staple cavities 145. The staple cavities 145 are arranged in six longitudinal rows. Three rows of staple cavities 145 are positioned on a first side of a longitudinal slot 143 and three rows of staple cavities 145 are positioned on a second side of the longitudinal slot 143. Other arrangements of staple cavities 145 and staples 185 may be possible.

[0040] Referring again to FIG. 2, the staples 185 are supported by staple drivers 180 in the cartridge body 142. The drivers 180 are movable between a first, or unfired position, and a second, or fired, position to eject the staples 185 from the staple cavities 145. The drivers 180 are retained in the cartridge body 142 by a retainer 144 which extends around the bottom of the cartridge body 142 and includes resilient members 147 configured to grip the cartridge body 142 and hold the retainer 144 to the cartridge body 142. The drivers 180 are movable between their unfired positions and their fired positions by a sled 170. The sled 170 is movable between a proximal position adjacent the proximal end 148 and a distal position adjacent the distal end 149. The sled 170 comprises a plurality of ramped surfaces 175 configured to slide under the drivers 180 and lift the drivers 180, and the staples 185 supported thereon, toward the anvil 130.

[0041] Further to the above, the sled 170 is moved distally by a firing member 160. The firing member 160 is configured to contact the sled 170 and push the sled 170 toward the distal end 149. The longitudinal slot 143 defined in the cartridge body 142 is configured to receive the firing member 160. Referring primarily to FIG. 5, the anvil 130 also includes a slot 134 configured to receive the firing member 160. The firing member 160 further comprises a first cam 162 which engages the first jaw 112 and a second cam 164 which engages the second jaw 114. As the firing member 160 is advanced distally, the first cam 162 and the second cam 164 can control the distance, or tissue gap, between the deck 141 of the staple cartridge 140 and the anvil 130. The firing member 160 also comprises a knife 163 configured to incise the tissue captured intermediate the staple cartridge 140 and the anvil 130. It is desirable for the knife 163 to be positioned at least partially proximal to the ramped surfaces 175 such that the staples 185 are ejected ahead of the knife 163.

[0042] Further to the above, the knife 163 applies a longitudinal force to the tissue as the firing member 160 is moved distally toward the distal end 149. It should be understood that, while the knife 163 transects the tissue as the firing member 160 is moved distally, the knife 163 may also push the tissue distally toward the distal end 149 of the staple cartridge 140. In various circumstances, as a result, a portion of the tissue that the surgeon intended to staple may not be stapled. As discussed in greater detail below, the surgical stapling system 100 includes a tissue stop configured to impede and/or prevent the flow of tissue out of the distal end of the surgical stapling system 100.

[0043] Referring primarily to FIGS. 3 and 4, the staple cartridge 140 includes a tissue stop 190. The tissue stop 190 is positioned in the longitudinal slot 143 defined in the cartridge body 142. More specifically, the tissue stop 190 includes a pin portion 198 positioned in a pin aperture 146 defined in the longitudinal slot 143. The pin portion 198 is closely received in the pin aperture 146. The tissue stop 190 further includes a head 192 which extends above the deck 141. In various instances, referring primarily to FIG. 6, the anvil 130 can directly contact, or abut, the head 192 of the tissue stop 190. In such instances, the tissue stop 190 can comprise an anvil stop. In some such instances, which are described in greater detail further below, the anvil 130 and the tissue stop 190 can trap tissue between the anvil 130 and the staple cartridge 140 when the anvil 130 is moved into a closed position. In other circumstances, tissue may be positioned intermediate the head 192 of the tissue stop 190 and the anvil 130. In some such circumstances, the anvil 130 can compress the tissue against the tissue stop 190 when the anvil 130 is moved into a closed position. Alternative embodiments are envisioned in which the staple cartridge is movable relative to the anvil. In such circumstances, the tissue stop can be moved toward the tissue when the surgical stapling system is closed.

[0044] As discussed above, the knife 163 can push the tissue toward the tissue stop 190 as the knife 163 transects the tissue. The tissue stop 190 can inhibit and/or prevent the longitudinal flow of the tissue. The tissue stop 190 can dam the longitudinal flow of tissue. When the firing member 160 is moved from its proximal-most position toward its distal-most position (FIG. 5), the tissue can be pushed against the tissue stop 190 wherein an internal pressure and/or structural impedance can be generated within the tissue. The tissue stop 190 can provide a backstop. The head 192 of the tissue stop 190 is longitudinally-aligned with the knife 163 such that the tissue stop 190 can stop the flow of tissue along the cutting path of the knife 163. The tissue stop 190 includes a detent 196 configured to hold the tissue stop 190 in the pin aperture 146. The detent 196 can comprise one or more annular lips extending around the tissue stop 190 which are engaged with an edge defined on the cartridge body 142, for example. The detent 196 can inhibit the tissue stop 190 from lifting out of the pin aperture 146. In various embodiments, the tissue stop 190 and the pin aperture 146 can be configured and arranged such that the tissue stop 190 does not move relative to the cartridge deck 141. Other embodiments are envisioned in which the tissue stop 190 can move relative to the cartridge deck 141.

[0045] As the firing member 160 is advanced distally toward the tissue stop 190, as discussed above, the knife 163 can approach the tissue stop 190. The tissue stop 190 comprises a slot, or catch, 194 defined therein configured to at least partially receive the knife 163. In various instances, the knife 163 can abut the head 192 of the tissue stop 190 when the firing member 160 has reached its distal-most position. When the knife 163 contacts the tissue stop 190, the tissue stop 190 can also serve as a knife stop. When the knife 163 is in contact with the tissue stop 190, the firing member 160 can be prevented from being advanced further distally. In the event that the firing member 160 is being advanced by a manually-actuated firing trigger extending from the handle of the surgical instrument, the surgeon operating the surgical instrument can sense that the firing member 160 has been fully advanced when the knife 163 contacts the tissue stop 160. At such point, the surgeon can operate the surgical instrument to retract the firing member 160. In the event that the firing member 160 is being advanced by an electric motor, a computer or processor operating the electric motor can be configured to detect a sudden increase in force experienced by the firing member 160 and/or a sudden increase in torque generated by the electric motor and, in response thereto, determine that the firing stroke of the firing member 160 has been completed and/or automatically retract the firing member 160 proximally.

[0046] The tissue stop 190 is comprised of plastic, for example; however, the tissue stop 190 can be comprised of any suitable material. When the tissue stop 190 is configured to serve as a knife stop, the tissue stop 190 can be comprised of a material that can resist, or at least substantially resist, the incising force applied thereto by the knife 163. When the knife 163 is not readily replaceable, it is desirable to fabricate the tissue stop 190 out of a material that will not damage the knife 163. The knife 163 may not be readily replaceable when the knife 163 is part of the surgical stapling instrument, and not part of the replaceable cartridge. When the knife 163 is, in fact, part of the replaceable cartridge, damage to the knife 163 from contacting the tissue stop 190 may be less of a concern as the damage to the knife 163 would not occur until the end of the firing stroke and the knife 163 would not be used to cut tissue thereafter.

[0047] In addition to or in lieu of the tissue stop 190 acting as a knife stop, referring again to FIG. 5, the distal end 149 of the cartridge body 142 can serve as a distal stop for the firing member 160. More specifically, the firing member 160 can push the sled 170 distally until it contacts an interior distal wall 172 of the distal end 149 and, at such point, the distal advancement of the firing member 160, and the sled 170, can be impeded.

[0048] In various instances, further to the above, the tissue stop 190 may not deflect or displace downwardly within the pin aperture 146. In such instances, the tissue stop 190 can withstand the downward clamping force applied thereto when the anvil 130 is moved into a closed position and, in addition, the downward compression force applied thereto when the anvil 130 is moved downwardly toward the cartridge 140 by the firing member 160. As discussed above, the firing member 160 comprises a first cam 162 configured to engage the first jaw 112 and a second cam 164 configured to engage the second jaw 114 wherein, when the firing member 160 is advanced distally, the firing member 160 can pull the anvil 130 toward the cartridge 140 and apply a compressive force to, one, the tissue captured between the anvil 130 and the cartridge 140 and, two, the tissue stop 190. The compressive force applied to the tissue stop 190 by the firing member 160 can increase as the firing member 160 is advanced distally. For instance, the firing member 160 can apply an initial compressive force to the tissue stop 190 at the beginning of the firing stroke and a maximum compressive force to the tissue stop 190 when the firing member 160 reaches the end of its firing stroke. The interaction between the detent 196 and the cartridge body 142 can be sufficient to support the tissue stop 190 in position throughout the firing stroke of the firing member 160.

[0049] In various other instances, further to the above, the tissue stop 190 may deflect and/or displace downwardly within the pin aperture 146. The tissue stop 190 can be slidably mounted in the pin aperture 146, for example. In at least one instance, the tissue stop 190 can withstand the downward clamping force applied thereto when the anvil 130 is moved into a closed position and then deflect and/or displace downwardly during the firing stroke of the firing member 160. In some instances, the tissue stop 190 can deflect and/or displace downwardly as a result of the initial compressive force applied to the tissue stop 190 at the beginning of the firing stroke of the firing member 160. In such instances, the tissue stop 190 comprises a feature which resists recessing under a load less than the load experienced during the firing stroke. In certain instances, the tissue stop 190 can deflect and/or displace downwardly as a result of the maximum compressive force applied to the tissue stop 190 at the end of the firing stroke of the firing member 160. In other instances, the tissue stop 190 can deflect and/or displace downwardly when the firing member 160 is between the beginning and the end of the firing stroke. In embodiments including the detent 196, the detent 196 can be configured to hold the tissue stop 190 in position until the compressive force applied to the tissue stop 190 exceeds a threshold force. At such point, the detent 196 can be defeated and the tissue stop 190 can move downwardly into the pin aperture 146. In various embodiments, the head 192 of the tissue stop 190 may recede entirely below the deck 141 of the cartridge 140 while, in other embodiments, the head 192 may not recede entirely below the deck 141. Even though the tissue stop 190 may give way during the firing stroke of the firing member 160, the tissue stop 190 may still perform the function of preventing and/or limiting the distal flow of the tissue before it gives way. At such point, a portion of the firing stroke, and possibly a large portion of the firing stroke, may have been completed.

[0050] In addition to or in lieu of the detent 196, a support can be positioned under the tissue stop 190 to prevent the tissue stop 190 from deflecting and/or displacing downwardly. The support can be pushed distally by the firing member 160 during the firing stroke of the firing member 160 such that the support no longer supports the tissue stop 190 and, as a result, the tissue stop 190 can give way or recess during the firing stroke of the firing member 160, as discussed above. In various instances, the support can be pushed out of the way at the end of the firing stroke of the firing member 160, for example. In other instances, the support can be pushed out of the way prior to the end of the firing stroke of the firing member 160. The support can be comprised of foam, for example. In various instances, the support can be comprised of a resilient material which can permit the tissue stop 190 to partially recess under a compressive load until the support is pushed out from underneath the tissue stop 190. In certain instances, the support can be comprised of a rigid material which does not permit the tissue stop 190 to recess, or at least substantially recess, until the support is pushed out from underneath the tissue stop 190.

[0051] The tissue stop 190 further comprises a slot 193 defined therein. The slot 193 is a clearance slot configured to receive a portion of the firing member 160 as the firing member 160 moves distally.

[0052] The head 192 of the tissue stop 190 can comprise any suitable configuration. In various instances, the head 192 can comprise a substantially cylindrical configuration, for example. In some instances, the head 192 can comprise a substantially rectangular configuration, for example. Such a rectangular shape can utilize the space in between the innermost rows of drivers and can be guided by the side walls of the cartridge slot 143. The head 192 can comprise rounded edges and/or surfaces which can reduce the pressure or stress applied to the tissue.

[0053] Referring again to the staple cartridge 140 depicted in FIG. 2, the staple cavities 145 defined in the staple cartridge 140 are arranged in three parallel rows on a first side of the longitudinal slot 143 which are parallel to the longitudinal slot 143 and three parallel rows on a second side of the longitudinal slot 143 which are also parallel to the longitudinal slot 143. On each side of the longitudinal slot 143, a first row of staple cavities 184′ is adjacent the longitudinal slot 143, a second row of staple cavities 184″ is adjacent the first row of staple cavities 184′, and a third row of staple cavities 184′″ is adjacent the second row of staple cavities 184″. The staple cavities 145 deploy an array of staples which include overlapping staples. With particular regard to the staple cavities 145 in the first row of staple cavities 184′, a gap is present between adjacent staple cavities 145 within the first row 184′; however, such gaps are laterally overlapped by staple cavities 145 in the second row of staple cavities 184″. Similarly, a gap is present between adjacent staple cavities 145 in the second row of staple cavities 184″ wherein such gaps are laterally overlapped by staple cavities 185 in the third row of staple cavities 184′″.

[0054] A staple cartridge 240 is depicted in FIG. 8. The staple cartridge 240 is similar to the staple cartridge 140 in many respects and can be used as part of the surgical stapling system 100 discussed above. When a staple cartridge 240 is used with the surgical stapling system 100, such a system can be referred to as a surgical stapling system 200 (FIG. 9). The staple cartridge 240 comprises a cartridge body 242, a deck 241 defined on the cartridge body 242, a longitudinal slot 243, a proximal end 248, and a distal end 249. The cartridge body 242 includes a plurality of first staple cavities 245a, a plurality of second staple cavities 245b, and a plurality of third staple cavities 245c defined therein. The first staple cavities 245a each include a first staple 285a removably stored therein. The second staple cavities 245b each include a second staple 285b removably stored therein. The third staple cavities 245c each include a third staple 285c removably stored therein. The first staples 285a are different than the second staples 285b and the third staples 285c. The second staples 285b are different than the third staples 285c. The first staples 285a, the second staples 285b, and the third staples 285c define an advantageous staple pattern, as described in greater detail further below.

[0055] The staple cavities 245a-245c, and the staples 285a-285c positioned therein, are arranged in three longitudinal rows on a first side of the longitudinal slot 243 and three longitudinal rows on a second side of the longitudinal slot 243. The three longitudinal rows of staple cavities 245a-245c, and staples 285a-285c, on the second side of the longitudinal slot 243 are a mirror image of three longitudinal rows of staple cavities 245a-245c, and staples 285a-285c, on the first side of the longitudinal slot 243; however, alternative embodiments are envisioned in which the second side is not a mirror image of the first side. Referring again to FIG. 8, a first longitudinal row of staple cavities 284′ is adjacent the longitudinal slot 283, a second longitudinal row of staple cavities 284″ is adjacent the first longitudinal row of staple cavities 284′, and a third longitudinal row of staple cavities 284′″ is adjacent the second longitudinal row of staple cavities 284″. The first longitudinal row 284′, the second longitudinal row 284″, and the third longitudinal row 284′″ are parallel to each other and to the longitudinal slot 243; however, alternative embodiments are envisioned in which the first longitudinal row 284′, the second longitudinal row 284″, and/or the third longitudinal row 284′″ are not parallel to each other and/or to the longitudinal slot 243.

[0056] The first longitudinal row 284′ comprises two first staple cavities 245a at a proximal end thereof and, in addition, two first staple cavities 245a at a distal end thereof. A large longitudinal gap is present between the proximal first staple cavities 245a and the distal first staple cavities 245a in the first row 284′. This large longitudinal gap is large enough such that more than one first staple cavity 245a could be positioned therein. Stated another way, if a pattern of first staple cavities 245a were arranged in the first row 284′ at regular intervals, several of the first staple cavities 245a are missing, or not present, within the large longitudinal gap. The first longitudinal row of staple cavities 284′ comprises an interruption in the pattern of staple cavities. The interruption comprises an absence of staple cavities. As a result, the first longitudinal row of staples comprises an interruption in the pattern of staples. This interruption comprises an absence of staples.

[0057] Similar to the above, the second longitudinal row 284″ comprises two first staple cavities 245a at a proximal end thereof and, in addition, two first staple cavities 245a at a distal end thereof. A large longitudinal gap is present between the proximal first staple cavities 245a and the distal first staple cavities 245a in the second row 284″. This large longitudinal gap is large enough such that more than one first staple cavity 245a could be positioned therein. Stated another way, if a pattern of first staple cavities 245a were arranged in the second row 284″ at regular intervals, several of the first staple cavities 245a are missing, or not present, within the large longitudinal gap. The second longitudinal row of staple cavities 284″ comprises an interruption in the pattern of staple cavities. The interruption comprises and an absence of staple cavities. As a result, the second longitudinal row of staples comprises an interruption in the pattern of staples. This interruption comprises an absence of staples.

[0058] The third longitudinal row 284′″ comprises two second staple cavities 245b at a proximal end thereof and, in addition, two second staple cavities 245b at a distal end thereof. The third row 284′″ further comprises third staple cavities 245c positioned intermediate the proximal second staple cavities 245b and the distal second staple cavities 245b. As illustrated in FIG. 8, the third staple cavities 245c are longitudinally wider than the second staple cavities 245b. The wider third staple cavities 245c comprise a disruption in the pattern of second staple cavities 245b in the third row 284′″. The second staple cavities 245b and the third staple cavities 245c comprise a continuous, albeit disrupted, pattern of staple cavities. As also illustrated in FIG. 8, the third staples 285c are longitudinally wider than the second staples 285b. The wider third staples 285c comprise a disruption in the pattern of second staples 285b in the third row 284′″. The second staples 285b and the third staples 285c comprise a continuous, albeit disrupted, pattern of staples.

[0059] Further to the above, and referring again to FIG. 8, the interruption, or longitudinal gap, in the first row of staple cavities 284′ is aligned, or at least substantially aligned, with the interruption, or longitudinal gap, in the second row of staple cavities 284″. As also illustrated in FIG. 8, the disruption in the third row of staple cavities 284′″ is aligned, or at least substantially aligned, with the interruption, or longitudinal gap, in the second row of staple cavities 284″ and the interruption, or longitudinal gap, in the first row of staple cavities 284′. The third row of staple cavities 284′″ includes staple cavities which span from the proximal end 248 to the distal end 249 of the staple cartridge 240 while the first row 284′ and the second row 284″ do not.

[0060] Referring again to FIG. 8, the first staples 285a are comprised of wire, for example. The wire can be comprised of stainless steel and/or titanium, for example. The wire has a circular cross-section; however, alternative cross-sections may be utilized. Each first staple 285a can comprise any suitable configuration such as, for example, a V-shaped configuration or a U-shaped configuration. A first staple 285a comprising a V-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are non-parallel to one another. A first staple 285a comprising a U-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are parallel to one another.

[0061] The second staples 285b are comprised of wire, for example. The wire can be comprised of stainless steel and/or titanium, for example. The wire has a rectangular cross-section; however, alternative cross-sections may be utilized. Each second staple 285b can comprise any suitable configuration such as, for example, a V-shaped configuration or a U-shaped configuration. A second staple 285b comprising a V-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are non-parallel to one another. A second staple 285b comprising a U-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are parallel to one another.

[0062] The third staples 285c are comprised of wire, for example. The wire can be comprised of stainless steel and/or titanium, for example. The wire has a circular cross-section; however, alternative cross-sections may be utilized. Each third staple 285c can comprise any suitable configuration such as, for example, a V-shaped configuration or a U-shaped configuration. A third staple 285c comprising a V-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are non-parallel to one another. A third staple 285c comprising a U-shaped configuration can include a base, a first leg extending from a first end of the base, and a second leg extending from a second end of the base, wherein the first leg and the second leg extend in directions which are parallel to one another.

[0063] As discussed above, the third staples 285c are longitudinally wider than the second staples 285b. In various instances, the third staples 285c are twice as wide, longitudinally, than the second staples 285b, for example. The third staples 285c can be at least twice as wide, longitudinally, than the second staples 285b, for example. In some instances, the third staples 285c are thrice as wide, longitudinally, than the second staples 285b, for example. Similar to the above, the third staples 285c are longitudinally wider than the first staples 285a. In various instances, the third staples 285c are twice as wide, longitudinally, than the first staples 285a, for example. The third staples 285c can be at least twice as wide, longitudinally, than the first staples 285a, for example. In some instances, the third staples 285c are thrice as wide, longitudinally, than the first staples 285a, for example. Other embodiments are envisioned in which the first staples 285a, the second staples 285b, and the third staples 285c comprise any suitable width.

[0064] The second staples 285b are laterally wider than the third staples 285c. In various instances, the second staples 285b are twice as wide, laterally, than the third staples 285c, for example. The second staples 285b can be at least twice as wide, laterally, than the third staples 285c, for example. In some instances, the second staples 285b are thrice as wide, longitudinally, than the third staples 285c, for example. Similar to the above, the second staples 285b are laterally wider than the first staples 285a. In various instances, the second staples 285b are twice as wide, laterally, than the first staples 285a, for example. The second staples 285b can be at least twice as wide, laterally, than the first staples 285a, for example. In some instances, the second staples 285b are thrice as wide, laterally, than the first staples 285a, for example. The second staples 285b are comprised of thicker wire stock than the first staples 285a and the third staples 285c; however, other embodiments are envisioned in which the first staples 285a, the second staples 285b, and the third staples 285c comprise any suitable thickness.

[0065] The first staples 285a, the second staples 285b, and the third staples 285c have the same unformed height; however, other embodiments are envisioned in which the first staples 285a have a different unformed height than the second staples and/or the third staples. Similarly, other embodiments are envisioned in which the second staples 285b have a different unformed height than the third staples 285c. The first staples 285a, the second staples 285b, and the third staples 285c have the same deformed height; however, other embodiments are envisioned in which the first staples 285a have a different deformed height than the second staples and/or the third staples. Similarly, other embodiments are envisioned in which the second staples 285b have a different deformed height than the third staples 285c. The disclosures of U.S. Pat. No. 7,866,528, entitled STAPLE DRIVE ASSEMBLY, which issued on Jan. 1, 2011; U.S. Pat. No. 7,726,537, entitled SURGICAL STAPLER WITH UNIVERSAL ARTICULATION AND TISSUE PRE-CLAMP, which issued on Jun. 1, 2010; U.S. Pat. No. 7,641,091, entitled STAPLE DRIVE ASSEMBLY, which issued on Jan. 5, 2010; U.S. Pat. No. 7,635,074, entitled STAPLE DRIVE ASSEMBLY, which issued on Dec. 22, 2009; and U.S. Pat. No. 7,997,469, entitled STAPLE DRIVE ASSEMBLY, which issued on Aug. 16, 2011, are hereby incorporated by reference herein in their respective entireties.

[0066] The first staples 285a and the second staples 285b at the proximal ends of the rows 284′, 284″, and 284′″ comprise a proximal sealing cluster configured to seal tissue positioned over the proximal end of the staple cartridge 240. The first staples 285a and the second staples 285b at the distal ends of the rows 284′, 284″, and 284′″ comprise a distal sealing cluster configured to seal tissue positioned over the distal end of the staple cartridge 240. A sealing cluster of staples is configured to clamp the tissue and limit the flow of fluids, such as blood, for example, therethrough. A sealing cluster can also hold or bind the tissue together. The third staples 285c comprise a holding or binding cluster configured to hold or bind the tissue together. The holding or binding cluster may also seal the tissue; however, the hemostasis that can be achieved with only one row of staples can be limited in certain circumstances.

[0067] Referring again to FIG. 8, the staple cartridge 240 also includes a tissue stop 190 which is configured to perform the same function as the tissue stop 190 of the staple cartridge 140, which is illustrated in FIG. 2. Referring again to FIG. 2, the distal-most staple cavities 145 and, thus, the distal-most staples 185, are positioned laterally with respect to the tissue stop 190. The tissue stop 190 extends proximally with respect to the distal ends of the first staple cavity row 184′ and the third staple cavity row 184′″. Such an arrangement stops the knife 163 proximally with respect to the distal-most staples 185 such that the knife 163 does not cut beyond the distal ends of the staple lines. Similarly, referring again to FIG. 8, the distal-most staple cavities 245a-245c and, thus, the distal-most staples 285a-285c, are positioned laterally with respect to the tissue stop 190. The tissue stop extends proximally with respect to the distal end of at least one staple cavity row 284′, 284″, and 284′″. Such an arrangement stops the knife 163 proximally with respect to the distal-most staples 285a-285c such that the knife 163 does not cut beyond the distal ends of the staple lines. In various instances, the tissue stop 190 comprises a pin that extends or reaches into the staple pattern.

[0068] Turning now to FIGS. 9-12, a surgical technique for performing a surgical anastomosis is disclosed. In various instances, an anastomosis is performed to remove a section of a patient's gastrointestinal (GI) tract. As illustrated in FIG. 9, a surgical stapling system 100 can be attached to a surgical instrument 101 and inserted laparascopically into the patient. The anvil 130 can be opened such that the anvil 130 and the staple cartridge 140 of the stapling system 100 are positioned relative to the patient's colon C. When the anvil 130 is moved into a closed position, the anvil 130 can clamp the colon C against the staple cartridge 140. In various instances, the tissue stop 190 can be positioned on one side of the colon C such that, when the anvil 130 is closed, the colon C can be entirely trapped within the stapling system 100.

[0069] As also illustrated in FIG. 9, a surgical stapling system 200 can be attached to a surgical instrument 201 and inserted laparascopically into the patient. The anvil 130 can be opened such that the anvil 130 and the staple cartridge 240 of the stapling system 200 are positioned relative to the patient's colon C. When the anvil 130 is moved into a closed position, the anvil 130 can clamp the colon C against the staple cartridge 240. In various instances, the tissue stop 190 can be positioned on one side of the colon C such that, when the anvil 130 is closed, the colon C can be entirely trapped within the stapling system 200. At such point, a section C′ of the colon C can be intermediate the clamped first stapling system 100 and the clamped second stapling system 200.

[0070] Turning now to FIG. 10, the first stapling system 100 can be operated to completely transect and staple the colon Cat a first, or upper, location. Three rows 184 of the staples 185 are implanted on the upper side of the transection and three rows of the staples 185 are implanted in the colon section C′. The second stapling system 200 can be operated to completely transect and staple the colon C at a second, or lower, location. Three rows of staples, i.e., a first row 284a, a second row 285b, and a third row 285c, are implanted on the lower side of the transection and three rows of staples, i.e., a first row 284a, a second row 285b, and a third row 285c, are implanted in the colon section C′. Once the colon has been transected and stapled at the upper location and the lower location, the colon section C′ can be removed from the patient, as illustrated in FIG. 10.

[0071] Referring again to FIG. 10, a surgical stapling system 300 can be utilized to reconnect the upper portion and the lower portion of the colon C. A staple cartridge portion 340 of the stapling system 300 is inserted into the rectum R of the patient into the lower portion of the colon C. A connecting rod 310 extending from the stapling system 300 is then inserted through the staple line 284c and the interruptions in the staples 284a and 284b. An anvil portion 330 of the stapling system 300 is positioned in the upper portion of the colon C. In various instances, the sidewall of the upper portion of the colon C can be incised and the anvil portion 330 can then be positioned inside the upper portion. A connection portion 331 of the anvil 330 can positioned such that it protrudes through the sidewall of the upper colon portion and can be connected to the connecting rod 310 of the staple cartridge portion 340. Referring now to FIG. 11, the connecting rod 310 can be retracted to pull the anvil portion 330 toward the staple cartridge portion 340 and the upper colon portion toward the lower colon portion. The anvil portion 330 can be retracted until the tissue of the upper colon portion and the lower colon portion are compressed against the staple cartridge 340.

[0072] The stapling assembly 300 comprises a circular stapling assembly. A circular stapling assembly can form one or more circular rings of staples in the tissue captured between the anvil portion 330 and the staple cartridge portion 340. The staple cartridge 340 comprises a plurality of staples 385 removably stored therein which are pushed toward the anvil 330 by staple pushers 380. The pushers 380 are pushed toward the anvil portion 330 by a firing member movably positioned in a shaft 320 of the stapling assembly 300. The firing member also pushes a circular knife 363 toward the anvil portion 330 to transect the tissue positioned radially inwardly with respect to the staple lines created by the staple cartridge portion 340. After the staples 385 have been fired and the tissue has been transected, the anvil portion 330 is disconnected from the connecting rod 310. The cartridge portion 340 of the stapling assembly 300 is then withdrawn from the patient's rectum. The anvil portion 330 is removed from the patient's colon and the incision used to insert the anvil portion 330 into the colon is closed via suturing, for example. The transected tissue, discussed above, often takes the shape of an annular ring which passes naturally through the patient's GI tract. The disclosure of U.S. Pat. No. 8,360,297, entitled SURGICAL CUTTING AND STAPLING INSTRUMENT WITH SELF ADJUSTING ANVIL, which issued on Jan. 29, 2013, is incorporated by reference in its entirety.

[0073] As illustrated in FIG. 11, the staples 385 can be deployed into the colon such that the third staples 285c are positioned within the ring, or rings, of staples 385. In certain circumstances, the ring of staples 385 may overlap with some of the third staples 285c. In various instances, the knife 263 may transect the tissue such that the third staples 285c are positioned in the transected ring of tissue. In such instances, all of the third staples 285c can be removed with the transected tissue. In some circumstances, the knife 263 may transect a third staple 285c and, as a result, a portion of a third staple 285c can be left in the remaining colon tissue.

[0074] At the end of the surgical technique, referring primarily to FIG. 12, the upper colon portion and the lower colon portion can be held together by the staples 385 deployed by the third stapling assembly 300. The lower colon portion can remain at least partially sealed by the first staples 285a and/or the second staples 285b. In various instances, some of the first staples 285a and/or the second staples 285 can be removed with the transected ring of tissue. In some instances, the staples 385 can overlap with the first staples 285a and the second staples 285b.

[0075] Referring again to FIG. 9, the surgical instrument 101 comprises an articulation joint 150 about which the stapling assembly 100 can be articulated. The stapling assembly 100 is articulatable about the articulation axis 151 (FIG. 1) which is perpendicular to the rotation axis 131 (FIG. 1) about which the anvil 130 is rotated. Similarly, the surgical instrument 201 comprises an articulation joint 250 about which the stapling assembly 200 can be articulated. Also, similarly, the stapling assembly 200 is articulatable about an articulation axis which is perpendicular to the rotation axis 131 about which the anvil 130 is rotated. The disclosure of U.S. Patent Application Publication No. 2013/0168435, entitled SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR, which published on Jul. 4, 2013, is incorporated by reference in its entirety.

[0076] As discussed above, referring again to FIG. 2, the sled 170 is advanced distally by a firing member 160 which is pushed distally by a surgical instrument. In certain other embodiments, referring now to FIG. 13, a sled 170′ can be pushed distally by a rotatable firing member 360. The sled 170′ includes a threaded aperture 361 which is threadably engaged with a thread 362 defined on the outside surface of the rotatable firing member 360. The sled 170′ is constrained from rotating relative to the staple cartridge and, as a result, the rotation of the firing member 360 displaces the sled 170′ proximally or distally, depending on the direction in which the firing member 360 is rotated. The sled 170′ can comprise a nut which is displaced longitudinally by a screw portion of the firing member 360. The disclosure of U.S. Patent Application Publication No. 2007/0175950, entitled DISPOSABLE STAPLE CARTRIDGE HAVING AN ANVIL WITH TISSUE LOCATOR FOR USE WITH A SURGICAL CUTTING AND FASTENING INSTRUMENT AND MODULAR END EFFECTOR SYSTEM THEREFOR, which published on Aug. 2, 2007, is incorporated by reference in its entirety.

[0077] The embodiment disclosed in FIG. 13 can be utilized in embodiments with articulation joints and without articulation joints. In embodiments with articulation joints, for example the firing member 360 can include a first rotatable shaft portion positioned proximally with respect to the articulation joint and a second rotatable shaft portion positioned distally with respect to the articulation joint. The first rotatable shaft portion can comprise a first gear, such as a bevel gear, for example, which is engaged with a second gear, such as a bevel gear, for example, to transmit the rotational motion therebetween. The first gear and the second gear can remain operably intermeshed throughout an articulation range of the surgical stapling system. In at least one instance, the articulation joint comprises an articulation axis which is parallel to the rotation axis 131 about which the anvil 130 is rotated, for example. In certain instances, the articulation joint can comprise an articulation axis which is not perpendicular to the rotation axis 131, for example. In such instances, the surgical stapling system can be maneuvered into positions that may not be reachable utilizing the articulation joint 150 and/or the articulation joint 250. In at least one instance, a surgical stapling system can be rotated into a ninety degree angle with respect to a shaft of a surgical stapling instrument, for example. In such instances, the second rotatable shaft can be orthogonal to the first rotatable shaft.

[0078] The entire disclosure of U.S. patent application Ser. No. 14/512,637, entitled STAPLE CARTRIDGE, which was filed on Oct. 13, 2014, is incorporated by reference herein.

[0079] A surgical instrument assembly 500 is illustrated in FIGS. 14-20. The surgical instrument assembly 500 comprises an end effector 510, a shaft 520, and an articulation joint 550 rotatably connecting the end effector 510 to the shaft 520. The shaft 520 comprises a longitudinal shaft axis 521, a spine, or frame, 522, and an outer tube 523. The end effector 510 comprises a longitudinal axis 511, a first jaw 512, and a second jaw 514. The first jaw 512 includes a replaceable staple cartridge 540 which is readily attachable to and detachable from the first jaw 512; however, other embodiments are envisioned in which the staple cartridge 540 is not readily removable from the first jaw 512. The staple cartridge 540 includes a cartridge body and a plurality of staples removably stored therein. The second jaw 514 includes an anvil 530 configured to deform the staples when the staples are ejected from the staple cartridge 540.

[0080] The second jaw 514 is movable relative to the first jaw 512; however, other embodiments are envisioned in which the first jaw 512 is movable relative to the second jaw 514. The second jaw 514 is rotatable about a closure axis 131 between an open position (FIG. 20) and a closed position (FIGS. 14, 15, 18, and 19). The closure axis 131 is transverse to the longitudinal end effector axis 511. In various instances, the closure axis 131 is orthogonal, for example, to the end effector axis 511. The second jaw 514 comprises pivot pins 516 extending laterally therefrom which are positioned in pivot windows 517 defined in the first jaw 512. The pivot pins 516 and the pivot windows 517 are sized and configured to permit the pivot pins 516 to float within the pivot windows 517; however, other embodiments are envisioned in which the pivot pins 516 and the pivot windows 517 define a fixed axis pivot. In either event, the pivot pins 516 and the pivot windows 517 define the closure axis 131.

[0081] Referring again to FIGS. 14-20, the articulation joint 550 connects a distal end of the shaft 520 to a proximal end of the end effector 510. Referring primarily to FIG. 16, the first jaw 512 of the end effector 510 comprises a channel mount 513 which includes articulation pins 518 extending laterally therefrom. The articulation pins 518 are positioned in articulation apertures 528 defined in the outer tube 523 of the shaft 520. The articulation pins 518 are closely received in the articulation apertures 528 to form a fixed axis pivot which defines an articulation axis 551 about which the end effector 510 is articulated relative to the shaft 520. The articulation axis 551 is transverse to the longitudinal shaft axis 521. In various instances, the articulation axis 551 is orthogonal, for example, to the shaft axis 521. The articulation axis 551 is parallel to the closure axis 131. The articulation axis 551 and the closure axis 131 are parallel if they are precisely parallel or substantially parallel. The articulation axis 551 and the closure axis 131 are longitudinally offset, but are laterally aligned, or point in the same general direction.

[0082] As discussed above, the end effector 510 is articulatable relative to the shaft 520. The end effector 510 is movable between an unarticulated position, such as the position illustrated in FIGS. 14, 15 and 18, and an articulated position, such as the position illustrated in FIGS. 19 and 20. The articulated position of the end effector 510 in FIGS. 19 and 20 is a fully articulated position; however, other articulated positions are envisioned. In an unarticulated position of the end effector 510, the longitudinal end effector axis 511 is longitudinally aligned with the longitudinal shaft axis 521. In an articulated position of the end effector 510, the longitudinal end effector axis 511 is no longer longitudinally aligned with, and extends transversely to, the longitudinal shaft axis 521. In the fully articulated position of the end effector 510 depicted in FIGS. 19 and 20, the end effector axis 511 is orthogonal to the shaft axis 521.

[0083] The surgical instrument assembly 500 further comprises an articulation actuation system configured to move the end effector 510 between an unarticulated position and an articulated position. Referring primarily to FIGS. 15-18 which depict the articulation actuation system in an unactuated configuration, the articulation actuation system comprises an electric motor 552 positioned in the shaft 520. More specifically, the housing of the electric motor 552 is positioned in a motor cavity 584 defined in the frame 522 of the shaft 520. The electric motor 552 can be mounted in the motor cavity 584 in such a way so as to prevent or inhibit the housing of the electric motor 552 from rotating relative to the shaft frame 522. The electric motor 552 can be operably coupled to a power source in the surgical instrument assembly 500, such as a battery, for example, which can be positioned in a handle or housing, for example, of the surgical instrument assembly 500. Electrically conductive wires, for example, can extend through a wire channel 584 defined in the shaft frame 522 to the power supply and/or control circuit positioned in the handle or housing of the surgical instrument assembly 500. The electric motor 552 further comprises a rotatable output shaft 553 which extends distally toward the end effector 510.

[0084] The articulation actuation system further comprises an articulation slide 554 positioned in the shaft 520. The articulation slide 554 includes a proximal drive aperture 555 defined therein. The motor output shaft 553 and the slide drive aperture 555 can be threadably engaged such that, when the motor output shaft 553 is rotated in a first direction, the articulation slide 554 is advanced distally and, when the motor output shaft 553 is rotated in a second, or opposite, direction, the articulation slide 554 is retracted proximally. The articulation slide 554 further comprises a longitudinal anti-rotation rib 556 extending therefrom which is positioned within, and keyed to, a longitudinal anti-rotation slot 526 defined in the outer tube 523 of the shaft 520. The anti-rotation rib 556 and slot 526 are sized and configured to prevent or inhibit the rotation of the articulation slide 554 within the shaft 520. As a result of the above, the rotation movement of the output shaft 553 is converted to longitudinal movement of the articulation slide 554.

[0085] The articulation actuation system further comprises articulation links 557 extending distally from the articulation slide 554. The articulation slide 554 comprises a distal pin aperture which is aligned with proximal link apertures 558 defined in the proximal ends of the articulation links 557. The distal pin aperture and the proximal link apertures 558 are configured to receive a proximal link pin therein which is configured to transmit the movement of the articulation slide 554 to the articulation links 557. The channel mount 513 comprises a projection lug extending proximally therefrom which includes a mounting aperture 519 (FIG. 17) aligned with distal link apertures 559 defined in the distal ends of the articulation links 557. The mounting lug aperture 519 and the distal link apertures 559 are configured to receive a distal link pin therein which is configured to transmit the movement of the articulation slide 554 and the articulation links 557 to the channel mount 513 of the first jaw 512. When the articulation slide 554, the articulation links 557, and the first jaw 512 are pushed distally by the articulation motor 552, as discussed above, the end effector 510 is rotated from its unarticulated position to its articulated position about the articulation axis 551. As discussed above, the second jaw 514 is rotatably mounted to the first jaw 512 and, as a result, the second jaw 514 rotates with the first jaw 512 as the end effector 510 is rotated into its articulated position.

[0086] In order to return the end effector 510 to its unarticulated position, further to the above, the articulation motor 552 is operated in the opposite direction to retract the articulation slide 554, the articulation links 557, and the first jaw 512 and rotate the end effector 510 about the articulation axis 511 in the opposite direction. In various instances, the articulation actuation system can be moved through a full articulation stroke in which the end effector 510 is moved between an unarticulated position and a fully articulated position. The beginning and the end of the articulation stroke can be controlled mechanically and/or electronically. For instance, the surgical instrument assembly 500 can comprise a control system including an encoder and a microprocessor, for example, configured to count the rotations of the articulation motor shaft 553 and interrupt the power supplied to the articulation motor 552 once a predetermined maximum number of rotations has been reached. Also, for instance, the anti-rotation slot 526 defined in the shaft tube 523 can comprise a distal end which limits the distal movement of the anti-rotation rib 556 of the articulation slide 554 and, thus, limits the articulation of the end effector 510. Similarly, the anti-rotation slot 526 can comprise a proximal end which limits the proximal movement of the anti-rotation rib 556 and, thus, limits the return articulation of the end effector 510.

[0087] The surgical instrument assembly 500 further comprises a firing drive configured to eject the staples from the staple cartridge 540, as discussed above. The firing drive comprises a first drive portion in the shaft 520 and a second drive portion in the end effector 510. In the unarticulated position of the end effector 510, referring primarily to FIGS. 15 and 18, the first drive portion is not operably engaged with the second drive portion. Thus, even if the first drive portion is motivated, the second drive portion will not respond to the motivation of the first drive portion. The second drive portion of the end effector 510 is engaged with the first drive portion of the shaft 520 when the end effector 510 is articulated, as illustrated in FIGS. 19 and 20. In various embodiments, the second drive portion is engaged with the first drive portion only when the end effector 510 is fully articulated, and not when the end effector 510 is only in a partially articulated position. In other embodiments, the second drive portion can be engaged with the first drive portion when the end effector 510 is in a partially articulated position, i.e., prior to the end effector 510 reaching a fully articulated position. In at least one such embodiment, the second drive portion of the end effector 510 is engaged with the first drive portion of the shaft 520 throughout a range of articulation positions of the end effector 510.

[0088] The first drive portion of the shaft 520 comprises a rotatable drive shaft 580. The drive shaft 580 is rotatable by any suitable means, such as an electric motor an/or a mechanical hand crank, for example. The electric motor and/or mechanical hand crank can be positioned within the handle or housing discussed above. In some instances, the handle or housing can comprise an articulation motor for operating the articulation actuation drive and a separate firing motor for operating the firing drive. In other instances, the articulation drive and the firing drive can be operated by the same electric motor. The disclosure of U.S. patent application Ser. No. 14/200,111, entitled CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS, which was filed on Mar. 7, 2014, now U.S. Patent Application Publication No. 2014/0263539, is incorporated by reference in its entirety. The drive shaft 580 is rotatably supported in a bearing aperture 581 extending through the frame 522 and a bearing aperture 582 extending through the articulation slide 554. The distal end of the drive shaft 580 comprises a shaft bevel gear 569 which is mounted to the drive shaft 580 such that the rotation of the drive shaft 580 is transmitted to the shaft bevel gear 569.

[0089] The second drive portion of the shaft 520 comprises an end effector bevel gear 568 mounted to the proximal end of a transfer shaft 567. The transfer shaft 567 is rotatably supported in a bearing aperture defined in the channel mount 513. The distal end of the transfer shaft 567 comprises a pinion gear 566 which is mounted to the transfer shaft 567 such that the rotation of the transfer shaft 567 is transmitted to the pinion gear 566. The pinion gear 566 is meshingly engaged with an intermediate gear 565 which is rotatably supported in the channel mount 513. The intermediate gear 565 is meshingly engaged with a driven gear 562 mounted to a firing shaft 560. The driven gear 562 is meshed with the intermediate gear 565 and the intermediate gear 565 is meshed with the pinion gear 566 such that the rotation of the pinion gear 566 is transmitted to the driven gear 562. The driven gear 562 is mounted to the firing shaft 560 such that the rotation of the driven gear 562 is transmitted to the firing shaft 560. As will be discussed in greater detail below, the rotation of the firing shaft 560 in a first direction fires, or ejects, the staples from the staple cartridge 540.

[0090] When the end effector 510 is in its unarticulated configuration, as illustrated in FIGS. 15 and 18, the shaft bevel gear 569 is not operably engaged with the end effector bevel gear 568. Stated another way, the teeth of the shaft bevel gear 569 are not meshingly engaged with the teeth of the end effector bevel gear 568 when the end effector 510 is in its unarticulated position. As a result, the drive shaft 580 cannot drive the firing shaft 560 when the end effector 510 is in its unarticulated position. When the end effector 510 is rotated into its articulated position, as illustrated in FIGS. 19 and 20, the teeth of the end effector bevel gear 568 can become meshingly engaged with the teeth of the shaft bevel gear 569. At such point, the drive shaft 580 can drive the firing shaft 560. It is envisioned that the drive shaft 580 will not be rotating when the bevel gears 568 and 569 are operably engaged; however, alternative embodiments are possible in which the end effector bevel gear 568 can mate with the shaft bevel gear 569 when the drive shaft 580 is moving.

[0091] In various instances, further to the above, at least one of the drive shaft 580 and the transfer shaft 567 can be free to rotate to accommodate and account for misalignment between the teeth of the end effector bevel gear 568 and the shaft bevel gear 569. Stated another way, the end effector bevel gear 568 may not always be presented to the shaft bevel gear 569 in a perfect alignment and, as a result, one or both of the bevel gears 568 and 569 may need to rotate slightly to mesh completely with one another. The disclosure of U.S. patent application Ser. No. 14/248,590, entitled MOTOR DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS, which was filed on Apr. 9, 2014, now U.S. Patent Application Publication No. 2014/0305987, is incorporated by reference in its entirety. In any event, the drive shaft 580 can drive the firing shaft 560 when the end effector 510 is in an articulated position. When the end effector 510 is rotated from its articulated position toward its unarticulated position, the end effector bevel gear 568 can become operably decoupled from the shaft bevel gear 569 and, as a result, the drive shaft 580 cannot drive the firing shaft 560.

[0092] In addition to the above, the firing shaft 560 comprises a proximal bearing 564 positioned at a proximal end thereof and a distal bearing 563 positioned at a distal end thereof which rotatably support the firing shaft 560 in the first jaw 512. The firing shaft 560 further comprises a threaded portion 561 which is threadably engaged with a firing member, or sled, 570. Referring primarily to FIG. 17, the sled 570 comprises a threaded aperture 571 which is threadably engaged with the threaded portion 561 of the firing shaft 560 such that, when the firing shaft 560 is rotated in a first direction, the sled 570 is advanced distally toward the distal bearing 563 and, when the firing shaft 560 is rotated in a second, or opposite, direction, the sled 570 is retracted proximally toward the proximal bearing 564. The sled 570 comprises one or more ramps 575 configured to slide under drivers movably positioned in staple cavities 541 defined in the staple cartridge 540 as the sled 570 is advanced distally. The ramps 575 lift the staple drivers, and the staples, positioned within the staple cavities 541 toward a top, or deck, surface 542 defined on the cartridge 540 and then continue to lift the staples into contact with the anvil 530 where the staples are deformed into a suitable configuration. The sled 570 further comprises a cutting portion 573, such as a knife edge, for example, which moves within and/or relative to a longitudinal slot 543 defined in the staple cartridge 540. The knife edge transects the tissue captured between the staple cartridge 540 and the anvil 530 as the tissue is being stapled during a firing stroke. The cutting portion 573 is integrally formed with the ramps 575; however, other embodiments are envisioned in which the cutting portion 573 and the ramps 575 comprise separate components.

[0093] The beginning and the end of the firing stroke can be controlled mechanically and/or electronically. For instance, the surgical instrument assembly 500 can comprise a control system including an encoder and a microprocessor, for example, configured to count the rotations of the drive shaft 580 and interrupt and/or reverse the polarity of the power supplied to the firing drive motor once a predetermined maximum number of rotations has been reached. Also, for instance, the staple cartridge 540 can comprise a distal stop which is contacted by the sled 570 at the end of the firing stroke.

[0094] The sled 570 further comprises a first camming member 572 configured to engage the first jaw 512 and a second camming member 574 configured to engage the second jaw 514. The first camming member 572 and the second camming member 574 can co-operate to position the second jaw 514 relative to the first jaw 512 as the sled 570 is advanced distally. In such instances, the camming members 572 and 574 position the anvil 530 relative to the staple cartridge 540 to control the gap, or tissue gap, between the anvil 530 and the staple cartridge 540. Moreover, the camming members 572 and 574 control the forming distance between the staple drivers and the anvil 530 and, as a result, control the formed height of the staples. Further to the above, alternative embodiments are envisioned in which the staple cartridge is moved relative to the anvil. In such embodiments, the camming members 572 and 574 could position the staple cartridge relative to the anvil.

[0095] As discussed above, the sled 570 is part of a firing system configured to fire the staples from the staple cartridge 540. The sled 570 may also be part of a closure system configured to close the second jaw 514. In such instances, the sled 570 may be advanced distally to contact the second jaw 514 and move the anvil 530 toward the staple cartridge 540 in order to clamp tissue against the staple cartridge 540. More specifically, the second camming member 574 would contact the second jaw 514 to move the second jaw 514 into a closed position. In order to re-open the second jaw 514 and reposition the end effector 510, for instance, the sled 570 could be retracted proximally such that the second camming member 574 is no longer in contact with the second jaw 514. A biasing member, such as a spring, for example could bias the second jaw 514 back into its open position.

[0096] In addition to or in lieu of the above, the surgical instrument assembly 500 further comprises a closure drive system. The closure drive system comprises a closure motor 590 positioned in the channel mount 513. The closure motor 590 comprises a motor housing supported by the channel mount 513 such that the motor housing is prevented or inhibited from rotating relative to the channel mount 513. Notably, the closure motor 590 is positioned distally with respect to articulation joint 550. The closure motor 590 can be operably coupled to a power source in the surgical instrument assembly 500, such as a battery, for example, which can be positioned in a handle or housing, for example, of the surgical instrument assembly 500. The battery can be positioned distally or proximally with respect to the articulation joint 550. Electrically conductive wires, for example, can extend through a wire channel defined in the shaft frame 522 to the power supply and/or control circuit positioned in the handle or housing of the surgical instrument assembly 500. The electrical wires can traverse the articulation joint 550 when the power supply and/or control circuit is located proximally with respect to the articulation joint 550.

[0097] The articulation motor 590 further comprises a rotatable output shaft 591 which extends distally toward the distal end of the end effector 510. The closure drive further comprises a closure slide 592 movably mounted to the channel mount 513 of the first jaw 512. The closure slide 592 comprises a proximal threaded aperture 593. The motor output shaft 591 comprises a threaded portion which is threadably engaged with the threaded aperture 593 defined in the closure slide 592 such that, when the motor output shaft 591 is rotated in a first direction, the closure slide 592 is advanced distally and, when the motor output shaft 591 is rotated in a second, or opposite, direction, the closure slide 592 is retracted proximally. The closure slide 592 comprises at least one lateral guide 594 received within a lateral slot defined in the channel mount 513 of the first jaw 512 which can constrain the movement of the closure slide 592. The closure slide 592 can be constrained such that it slides longitudinally between a proximal position and a distal position; however, other embodiments are envisioned in which the closure slide 592 comprises any suitable movement.

[0098] The second jaw 514 comprises a closure tab 515 extending upwardly from the proximal end thereof. The closure tab 515 is positioned within a window 595 defined in the distal end of the closure slide 592. When the closure slide 592 is advanced distally, a proximal sidewall of the window 595 contacts the closure tab 515 and rotates the anvil 530 of the second jaw 514 toward the staple cartridge 540 of the first jaw 512. The closure slide 592 can also push, or translate, the second jaw 514 distally if such motion is accommodated by the closure pivot joint connecting the second jaw 514 to the first jaw 512. If the closure pivot joint comprises a fixed axis pivot, the motion of the second jaw 514 is limited to rotational motion. When the closure slide 592 is retracted proximally, a distal sidewall of the window 595 contacts the closure tab 515 and rotates the anvil 530 of the second jaw 514 away from the staple cartridge 540 of the first jaw 512. The closure slide 592 can also pull, or translate, the second jaw 514 proximally if such motion is accommodated by the closure pivot joint.

[0099] Further to the above, the closure slide 592 is movable by the closure motor 590 through a full closure stroke in order to move the second jaw 514 between an open position and a closed position and, in addition, through a full opening stroke in order to move the second jaw 514 between a closed position and an open position. The channel mount 513 can comprise a proximal stop configured to stop the proximal movement of the closure slide 592 and limit the opening movement of the second jaw 514. The channel mount 513 can further comprise a distal stop configured to stop the distal movement of the closure slide 592 and limit the closing movement of the second jaw 514. In certain instances, the surgical instrument assembly 500 can comprise a control system including an encoder and a microprocessor, for example, configured to count the rotations of the closure motor shaft 591 and interrupt the power supplied to the closure motor 590 once a predetermined maximum number of rotations has been reached.

[0100] The closure slide 592 can be moved distally through the full closure stroke to clamp tissue against the staple cartridge 540 and then retracted proximally through the full opening stroke if the clinician is unsatisfied with the positioning of the tissue within the end effector 510. In some instances, the closure slide 592 may be moved only partially through its closure stroke to clamp tissue against the staple cartridge 540. In such instances, the clinician can assess whether the tissue is properly positioned within the end effector 510 before fully closing the second jaw 514. In some instances, the closure slide 592 may be moved only partially through its opening stroke to release the tissue. In such instances, the end effector 510 can be repositioned relative to the tissue without having to fully open the second jaw 514.

[0101] In use, in certain instances, the second jaw 514 can be moved into an open position such that a staple cartridge 530, for example, can be inserted into the first jaw 512. The second jaw 514 can then be moved into a closed position, or an at least substantially closed position, such that at least the end effector 510 of the surgical instrument assembly 500 can be inserted through a trocar into a patient. The end effector 510 can be in an unarticulated configuration when it is inserted through the trocar. Once the end effector 510 has passed through the trocar, the end effector 510 can be rotated into its articulated position by the articulation actuation system, discussed above, and/or the second jaw 514 can be re-opened by the closure drive system, also discussed above. The electrical controls of the surgical instrument assembly 500 can be configured to permit the closure drive system to be operated when the end effector 510 is in an unarticulated position and/or an articulated position.

[0102] In some instances, further to the above, it may be desirable to operate the closure drive system at the same time as the articulation actuation system. Such instances can make the surgical instrument assembly 500 readily manipulatable. In other instances, it may not be desirable to operate the closure drive system at the same time as the articulation drive system as doing so may make the surgical instrument assembly 500 difficult to control for an inexperienced clinician. In such instances, the electrical controls of the surgical instrument assembly 500 can be configured to interrupt the supply of power to the closure motor 590 when the articulation motor 552 is being operated. Similarly, the electrical controls of the surgical instrument assembly 500 can be configured to interrupt the supply of power to the articulation motor 552 when the closure motor 590 is being operated. When tissue is clamped between the anvil 530 and the staple cartridge 540, it may not be desirable to articulate the end effector 540. The electrical controls of the surgical instrument assembly 500 can interrupt power to the articulation motor 552 when the second jaw 514 is in an at least partially closed position and the end effector 510 is in an articulated position. In certain instances, the surgical instrument assembly 500 can include an electronic lockout system, such as those disclosed in U.S. Pat. No. 7,644,848, entitled ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENT INCLUDING SAME, which issued on Jan. 12, 2010. The entire disclosure of U.S. Pat. No. 7,644,848, entitled ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENT INCLUDING SAME, is incorporated by reference.

[0103] The reader should appreciate that, although the closure drive system can be operated when the end effector 510 is in an unarticulated position, the second drive portion of the firing drive system is operably disconnected from the first drive portion of the firing drive system when the end effector 510 is in an unarticulated position. The electrical controls of the surgical instrument assembly 500 can be configured to detect when the end effector 510 is in a position in which the first drive portion is not operably engaged with the second drive portion and prevent the first drive portion of the firing drive system from being operated. Similar to the above, the power supplied to the electrical motor of the firing drive system can be interrupted to prevent the first drive portion of the firing drive system from being operated. In such instances, a hard or sudden start of the sled 570 can be avoided by preventing, or at least reducing the possibility of, the first drive portion engaging an already moving second drive portion. Once the electrical controls detect that the end effector 510 is in a position in which the first drive portion is engaged with the second drive portion, the electrical controls can permit the first drive portion of the firing drive system to be operated.

[0104] Once the end effector 510 has been suitably articulated, the second drive portion of the firing drive system has been engaged with the first drive portion, and the tissue has been properly clamped between the anvil 530 and the staple cartridge 540, the firing drive system can be operated to advance the sled 570 distally through a firing stroke to staple and incise the tissue. The first camming member 572 and second camming member 574 can co-operate to position the anvil 530 relative to the staple cartridge 540 and control the height in which the staples are formed. It may be desirable that the end effector 510 is not articulated during the firing stroke. The electrical controls of the surgical instrument assembly 500 may prevent the articulation actuation system from being operated while the firing drive system is being operated. Similarly, it may be desirable to prevent the closure drive from attempting to open the second jaw 514 during a firing stroke. The electrical controls of the surgical instrument assembly 500 may prevent the closure drive system from being operated while the firing drive is operated. It may also be desirable to prevent the articulation actuation system and the closure drive system from being operated if the sled 570 has been at least partially advanced regardless of whether the firing drive system is currently being operated. After at least some of the staples stored in the staple cartridge 540 have been fired, the sled 570 must be retracted before the anvil 530 can be re-opened to release the tissue. Once the tissue has been released, the end effector 510 can be returned back to its unarticulated position and the second jaw 514 can be re-closed before the end effector 510 is withdrawn from the patient through the trocar, for example.

[0105] As discussed above, the firing drive system of the surgical instrument assembly 500 is operably coupled when the end effector 510 is articulated. Other embodiments are envisioned in which any suitable drive system, such as a closure drive system, for example, is operably coupled when an end effector is introduced into a surgical site, and then articulated, for example.

[0106] The surgical instrument assembly 500 is also illustrated in FIGS. 21-28. In these figures, a staple cartridge 640 is positioned in the first jaw 512 instead of the staple cartridge 540. The staple cartridge 640 is similar in many respects to the staple cartridge 240 discussed above. Like the staple cartridge 240, the staple cartridge 640 also includes a tissue stop. The staple cartridge 640 includes a tissue stop 690 configured to prevent or at least inhibit the distal migration of tissue within the end effector 510. The tissue stop 690 is deployable between an undeployed position, as illustrated in FIG. 25, and a deployed position, as illustrated in FIG. 26. Referring primarily to FIGS. 21 and 22, the tissue stop 690 is positioned in the distal end of the longitudinal slot 243 of the staple cartridge 640. The tissue stop 690 comprises a first end 691 rotatably mounted to the cartridge body and a second end 692 configured to be in contact with the anvil 530. The staple cartridge 640 further comprises a biasing member, such as a torsion spring, for example, configured to bias the tissue stop 690 toward its deployed position.

[0107] In use, referring to FIG. 25, the staple cartridge 640 can be positioned in the first jaw 512 and the tissue stop 690 can be held in its undeployed position by the second jaw 514 as the end effector 510 is inserted through a trocar, for example, into a patient. In such an undeployed position, the tissue stop 690 can be at least partially stowed in the longitudinal slot 243. When the second jaw 514 is moved into an open position to position tissue between the anvil 530 and the staple cartridge 640, referring to FIG. 26, the torsion spring can bias the tissue stop 690 into its deployed position. In various instances, referring primarily to FIG. 23, the staple cartridge 640 can be positioned on a first side of a patient's colon C and the anvil 530 can be positioned on a second side of the colon C. Referring to FIGS. 23 and 24, the design of the surgical instrument assembly 500 can be advantageously utilized to easily position the articulated end effector 510 relative to the colon C. The colon C can be positioned in the end effector 510 such that the colon C is positioned proximally with respect to the tissue stop 690, as illustrated in FIG. 26. When the second jaw 514 is closed once again, the anvil 530 can contact the second end 692 of the tissue stop 690 and trap the colon C in the end effector 510, as illustrated in FIG. 27. In various instances, the anvil 530 can then be driven toward the staple cartridge 640 to deform the tissue stop 690 and move the anvil 530 into a fully closed position. Such deformation may be plastic deformation and/or elastic deformation. In certain instances, the anvil 530 can permanently deform the tissue stop 690. In at least one instance, the anvil 530 can crush the tissue stop 690, as illustrated in FIG. 28. The staple cartridge 640 can comprise a lock configured to hold the tissue stop 690 in its deployed configuration. In various instances, the tissue stop 690 can be comprised of plastic, for example.

[0108] In various instances, further to the above, the anvil 530 may deform the tissue stop 690 prior to the firing stroke of the end effector 510. In other instances, the anvil 530 may not deform the tissue stop 690 prior to the firing stroke of the end effector 510. The anvil 530 may deform the tissue stop 690 as the sled 570 is advanced distally. In at least one instance, the anvil 530 can gradually deform the tissue stop 690 as the sled 570 is advanced distally. In such instances, the amount in which the tissue stop 690 is deformed is a function of the position of the sled 570. This function may be a linear function or a non-linear function, for example. In other instances, the tissue stop 690 can deform, buckle, and/or collapse suddenly. The tissue stop 690 can collapse at the beginning of the firing stroke or at some later point in the firing stroke.

[0109] The entire disclosures of:

[0110] U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC DEVICE, which issued on Apr. 4, 1995;

[0111] U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21, 2006;

[0112] U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK, which issued on Sep. 9, 2008;

[0113] U.S. Pat. No. 7,464,849, entitled ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS, which issued on Dec. 16, 2008;

[0114] U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR, which issued on Mar. 2, 2010;

[0115] U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS, which issued on Jul. 13, 2010;

[0116] U.S. Pat. No. 8,393,514, entitled SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE, which issued on Mar. 12, 2013;

[0117] U.S. patent application Ser. No. 11/343,803, entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES; now U.S. Pat. No. 7,845,537;

[0118] U.S. patent application Ser. No. 12/031,573, entitled SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES, filed Feb. 14, 2008;

[0119] U.S. patent application Ser. No. 12/031,873, entitled END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb. 15, 2008, now U.S. Pat. No. 7,980,443;

[0120] U.S. patent application Ser. No. 12/235,782, entitled MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT, now U.S. Pat. No. 8,210,411;

[0121] U.S. patent application Ser. No. 12/249,117, entitled POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM, now U.S. Pat. No. 8,608,045;

[0122] U.S. patent application Ser. No. 12/647,100, entitled MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY, filed Dec. 24, 2009; now U.S. Pat. No. 8,220,688;

[0123] U.S. patent application Ser. No. 12/893,461, entitled STAPLE CARTRIDGE, filed Sep. 29, 2012, now U.S. Pat. No. 8,733,613;

[0124] U.S. patent application Ser. No. 13/036,647, entitled SURGICAL STAPLING INSTRUMENT, filed Feb. 28, 2011, now U.S. Pat. No. 8,561,870;

[0125] U.S. patent application Ser. No. 13/118,241, entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Patent Application Publication No. 2012/0298719;

[0126] U.S. patent application Ser. No. 13/524,049, entitled ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, filed on Jun. 15, 2012, now U.S. Patent Application Publication No. 2013/0334278;

[0127] U.S. patent application Ser. No. 13/800,025, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. Patent Application Publication No. 2014/0263551;

[0128] U.S. patent application Ser. No. 13/800,067, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. Patent Application Publication No. 2014/0263552;

[0129] U.S. Patent Application Publication No. 2007/0175955, entitled SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM, filed Jan. 31, 2006; and

[0130] U.S. Patent Application Publication No. 2010/0264194, entitled SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR, filed Apr. 22, 2010, now U.S. Pat. No. 8,308,040, are hereby incorporated by reference herein.

[0131] Although the various embodiments of the devices have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. Also, where materials are disclosed for certain components, other materials may be used. Furthermore, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. The foregoing description and following claims are intended to cover all such modification and variations.

[0132] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0133] Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

[0134] While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

[0135] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.