Surgical instrument and loading Unit for use Therewith

<u>CROSS-REFERENCE TO RELATED APPLICATIONS</u>

0001The present application is a continuation in part of <patcit id="pcit0001" dnum="US23575108A"><text>U.S. Patent Application Serial No. 12/235,751, filed September 23, 2008</text></patcit>, the disclosure of which is hereby incorporated by reference herein.

<u>BACKGROUND</u>

Technical

field

0002The present disclosure relates generally to instruments for surgically joining tissue and, more specifically, to surgical instruments having curved jaw members and loading units for use therewith.

Background of Related Art

0003Various types of surgical instruments used to surgically join tissue are known in the art, and are commonly used, for example, for closure of tissue or organs in transection, resection, anastomoses, for occlusion of organs in thoracic and abdominal procedures, and for electrosurgically fusing or sealing tissue.

0004One example of such a surgical instrument is a surgical stapling instrument, which may include an anvil assembly, a cartridge assembly for supporting an array of surgical staples, an approximation mechanism for approximating the cartridge and anvil assemblies, and a firing mechanism for ejecting the surgical staples from the cartridge assembly.

0005Using a surgical stapling instrument, it is common for a surgeon to approximate the anvil and cartridge members. Next, the surgeon can fire the instrument to emplace staples in tissue. Additionally, the surgeon may use the same instrument or a separate instrument to cut the tissue adjacent or between the row(s) of staples.

<u>SUMMARY</u>

0006The present disclosure relates to a surgical instrument for surgically joining tissue. The surgical instrument includes a handle assembly, a drive assembly, an endoscopic portion, a pair of jaw members, a dynamic clamping member, and a tissue stop. The drive assembly is disposed in mechanical cooperation with a movable handle of the handle assembly. The endoscopic portion defines a first longitudinal axis. The jaw members are each longitudinally curved with respect to the longitudinal axis. The dynamic clamping member is disposed in mechanical cooperation with a distal portion of the drive assembly and includes an upper beam, a lower beam, and a vertical beam having a cutting edge on a distal portion thereof. At least a portion of the dynamic clamping member is longitudinally curved with respect to the longitudinal axis. The tissue stop is disposed adjacent a distal portion of the first jaw member and configured to impede tissue from distally escaping the jaw members.

0007The present disclosure also relates to a loading unit configured for releasable engagement with a surgical instrument. The loading unit comprises a body portion, a drive assembly, a pair of jaw members, a dynamic clamping member, and a tissue stop. The body portion defines a longitudinal axis. A proximal portion of the body portion is configured for releasable engagement with an endoscopic portion of the surgical instrument. The drive assembly is slidingly disposed at least partially within the proximal body portion. The pair of jaw members extends generally distally from the proximal body portion and each of the jaw members is longitudinally curved with respect to the longitudinal axis. At least one of the jaw members is movable with respect to the other between an open position and an approximated position for engaging body tissue therebetween. The pair of jaw members includes a first jaw member and a second jaw member. The dynamic clamping member is disposed adjacent a distal portion of the drive assembly and includes an upper beam, a lower beam, and a vertical beam. The vertical beam connects the upper beam and the lower beam and includes a cutting edge on a distal portion thereof. The vertical beam is longitudinally curved with respect to the longitudinal axis. The tissue stop is disposed adjacent a distal portion of the first jaw member and is configured to impede tissue from distally escaping the jaw members.

0008The present disclosure also relates to a cartridge assembly for use with a surgical instrument. The cartridge assembly comprises a cartridge and a tissue stop. The cartridge includes a tissue contacting surface. The tissue stop is disposed in mechanical cooperation with a distal portion of the cartridge and is configured to impede tissue from distally escaping the jaw members. The tissue stop is movable from a first position wherein an upper surface of the tissue stop protrudes above the tissue contacting surface of the cartridge, and a second position wherein the upper surface is substantially flush with the tissue contacting surface of the cartridge.

0009The present disclosure also relates to a dynamic clamping member for use with a surgical instrument. The dynamic clamping member comprises an upper beam, a lower beam, and a vertical beam. The vertical beam connects the upper beam and the lower beam and includes a cutting edge on a distal portion thereof. The dynamic clamping member is asymmetrical about at least one of a vertical axis extending between a transverse center of the upper beam and a transverse center of the lower beam, and a horizontal axis extending transversely through a vertical center of the vertical beam. The horizontal axis is substantially perpendicular to the vertical axis.

<u>BRIEF DESCRIPTION OF FIGURES</u>

0010Various embodiments of the presently disclosed surgical instrument are disclosed herein with reference to the drawings, wherein:

0011<figref idref="f0001">Figure 1</figref> is a perspective view of a surgical stapling instrument including a loading unit in accordance with the present disclosure;

0012<figref idref="f0002">Figure 1A</figref> is a perspective view of another type of surgical stapling instrument including the loading unit of <figref idref="f0001">Figure 1</figref> in accordance with an embodiment of the present disclosure;

0013<figref idref="f0003">Figure 2</figref> is a perspective view of a handle assembly of the surgical stapling instrument of <figref idref="f0002">Figure 1A</figref>;

0014<figref idref="f0004">Figure 3</figref> is a perspective view of the loading unit of <figref idref="f0001">Figures 1 and 1</figref> A;

0015<figref idref="f0005">Figure 4</figref> is an enlarged view of the area of detail of <figref idref="f0001">Figures 1</figref> and <figref idref="f0002">1A</figref>;

0016<figref idref="f0006">Figure 5</figref> is a top view of the loading unit of <figref idref="f0004">Figures 3</figref> and <figref idref="f0005">4</figref>;

0017<figref idref="f0006">Figure 6</figref> is a side view of the loading unit of <figref idref="f0004 f0005 f0006">Figures 3-5</figref>, illustrated with a cartridge assembly in the open position;

0018<figref idref="f0007">Figure 7</figref> is a perspective, partial cross-sectional view of the loading unit of <figref idref="f0004 f0005 f0006">Figures 3-6</figref>;

0019<figref idref="f0008">Figure 8</figref> is a transverse cross-sectional view of the loading unit of <figref idref="f0004 f0005 f0006 f0007">Figures 3-7</figref>;

0020<figref idref="f0009">Figure 9</figref> is a longitudinal cross-sectional view of a portion of the loading unit of <figref idref="f0004 f0005 f0006 f0007 f0008">Figures 3-8</figref>;

0021<figref idref="f0010">Figure 10</figref> is a perspective assembly view of the loading unit of <figref idref="f0004 f0005 f0006 f0007 f0008 f0009">Figures 3-9</figref>;

0022<figref idref="f0011">Figure 11</figref> is a perspective view of a drive assembly and dynamic clamping member of the loading unit of <figref idref="f0004 f0005 f0006 f0007 f0008 f0009 f0010">Figures 3-10</figref>;

0023<figref idref="f0011">Figure 12</figref> is an enlarged view of the area of detail of <figref idref="f0011">Figure 11</figref>;

0024<figref idref="f0012">Figure 13</figref> is a perspective assembly view of the drive assembly and dynamic clamping member of <figref idref="f0011">Figures 11 and 12</figref>;

0025<figref idref="f0013 f0014">Figures 14-17</figref> are various views of the dynamic clamping member according to an embodiment of the present disclosure;

0026<figref idref="f0014">Figure 17A</figref> is a rear view of another embodiment of a dynamic clamping member according to another embodiment of the present disclosure;

0027<figref idref="f0014">Figure 17B</figref> is a perspective view of another embodiment of a dynamic clamping member according to another embodiment of the present disclosure;

0028<figref idref="f0015">Figures 18-20</figref> are various views of an actuation sled in accordance with an embodiment of the present disclosure;

0029<figref idref="f0016">Figures 21 and 22</figref> are perspective views of staples and staple pushers in accordance with embodiments of the present disclosure;

0030<figref idref="f0017">Figures 23-25</figref> are perspective views of various staple pushers in accordance with embodiments of the present disclosure;

0031<figref idref="f0018">Figure 26</figref> is a perspective view of a tissue stop for use with the loading unit of <figref idref="f0004 f0005 f0006 f0007 f0008 f0009 f0010">Figures 3-10</figref>;

0032<figref idref="f0018">Figure 27</figref> is a cross-sectional view of the tissue stop of <figref idref="f0018">Figure 26</figref> coupled to the loading unit; and

0033<figref idref="f0019 f0020">Figures 28-30</figref> are perspective views of the loading unit of <figref idref="f0004 f0005 f0006 f0007 f0008 f0009 f0010">Figures 3-10</figref> interacting with a layer of tissue at various stages of operation of the loading unit.

<u>DETAILED DESCRIPTION</u>

0034Embodiments of the presently disclosed surgical instrument, and loading unit for use therewith, are described in detail with reference to the drawings, wherein like reference numerals designate corresponding elements in each of the several views. As is common in the art, the term 'proximal" refers to that part or component closer to the user or operator, e.g., surgeon or physician, while the term "distal" refers to that part or component farther away from the user.

0035A first type of surgical stapling instrument of the present disclosure is indicated as reference numeral 10 in <figref idref="f0001">Figure 1</figref>. Another type of surgical stapling instrument of the present disclosure is indicated as reference numeral 10a in <figref idref="f0002">Figures 1A</figref> and <figref idref="f0003">2</figref>. Additionally, while not explicitly shown, the present application also relates to surgical stapling instruments having parallel jaw members and to electrosurgical instruments used to join tissue. Collectively, all surgical instruments (including surgical stapling instruments 10 and 10a) are referred to herein as "surgical instrument" and referred to as reference numeral 10. Similarly, several features that are common to both surgical stapling instruments are collectively referred to as the same reference number (e.g., handle assembly 12, rotation knob 14, and endoscopic portion 18). Further details of an endoscopic surgical stapling instrument are described in detail in commonly-owned <patcit id="pcit0002" dnum="US6953139B"><text>U.S. Patent No. 6,953,139 to Milliman et al.</text></patcit>, the entire contents of which are hereby incorporated by reference herein.

0036A loading unit (or "DLU") 500 for use with surgical instrument 10 is shown in <figref idref="f0004 f0005 f0006 f0007 f0008 f0009 f0010">FIGS. 3-10</figref> and <figref idref="f0019 f0020">28-30</figref>. DLU 500 is attachable to an elongated or endoscopic portion 18 of surgical instrument 10, e.g., to allow surgical instrument 10 to have greater versatility. DLU 500 may be configured for a single use, and/or may be configured to be used more than once. Examples of loading units for use with a surgical stapling instrument are disclosed in commonly-owned United States Patent No. <patcit id="pcit0003" dnum="US5752644A"><text>5,752,644 to Bolanos et al.</text></patcit>, the entire contents of which are hereby incorporated by reference herein.

0037DLU 500 includes a proximal body portion 502 and a tool assembly 504. Proximal body portion 502 defines a longitudinal axis "A-A," and is releasably attachable to a distal end of elongated body portion 18 of surgical instrument 10. Tool assembly 504 includes a pair of jaw members including an anvil assembly 506 and a cartridge assembly 508. One jaw member is pivotal in relation to the other. In the illustrated embodiments, cartridge assembly 508 is pivotal in relation to anvil assembly 506 and is movable between an open or unclamped position (e.g., <figref idref="f0005">FIGS. 4</figref> and <figref idref="f0006">6</figref>) and a closed or approximated position (e.g., <figref idref="f0008">FIG. 8</figref>). Cartridge assembly 508 is urged in the open position via a biasing member, e.g., a pair of compression springs 533 disposed between anvil cover 510 and cartridge 518 (see <figref idref="f0010">FIG. 10</figref>).

0038With reference to <figref idref="f0001">FIGS. 1</figref> and <figref idref="f0010">10</figref>, for example, tool assembly 504 has a pair of jaws including anvil assembly 506 and cartridge assembly 508. As shown, each of anvil assembly 506 and cartridge assembly 508 is longitudinally curved. That is, anvil assembly 506 and cartridge assembly 508 are curved with respect to the longitudinal axis "A-A" defined by proximal body portion 502. The term "distal" typically refers to that part or component of the instrument that is farther away from the user. As used herein, the terms "distal" and "proximal" will take into account the curvature of curved parts of the surgical instrument 10 of the present disclosure. For example, "distal" will refer to the portion of the curved part that is farthest from the user, along a trajectory defined by the curved part, such as trajectory C-C shown in <figref idref="f0005">FIG. 4</figref>. That is, while an intermediate portion of a curved part may be farther from the user during use, the portion of the curved part that is farthest along its longitudinal axis is considered "distal." Anvil assembly 506 has a proximal end 506a and a distal end 506b and cartridge assembly 508 has a proximal end 508a and a distal end 508b.

0039In certain embodiments, the radius of curvature of both anvil assembly 506 and cartridge assembly 508 is between about 1.00 inches and about 2.00 inches, and in particular, may be approximately 1.40 inches. The curved jaw members, as compared to straight jaw members, may help facilitate access to lower pelvis regions, e.g., during lower anterior resection ("LAR"). Additionally, the inclusion of curved jaw members may allow increased visualization to a surgical site and may also allow more room for a surgeon to manipulate target tissue or the jaw members themselves with his or her hand.

0040With reference to <figref idref="f0010">FIG. 10</figref>, anvil assembly 506 includes a cover and an anvil that are formed as an anvil cover 510 that is curved with respect to the longitudinal axis A-A, and an anvil plate 512 that is curved with respect to the longitudinal axis A-A, which includes a plurality of staple forming depressions 514 (<figref idref="f0009">FIG. 9</figref>). Anvil plate 512 is secured to an underside of anvil cover to define a channel 511 (<figref idref="f0008">FIG. 8</figref>) between plate 512 and cover 510. When tool assembly 504 is in the approximated position (<figref idref="f0008">FIG. 8</figref>), staple forming depressions 514 are positioned in juxtaposed alignment with cartridge assembly 508.

0041Cartridge assembly 508 includes a curved carrier 516 that is curved with respect to the longitudinal axis and which receives a curved cartridge 518 via a snap-fit connection. Cartridge 518 includes a pair of support struts 524 which rest on sidewalls 517 of carrier 516 to stabilize cartridge 518 on carrier 516. Support struts 524 also set the height or location of cartridge 518 with respect to anvil plate 512. An external surface of carrier 516 includes an angled cam surface 516a.

0042Cartridge 518 defines a plurality of laterally spaced staple retention slots 528, which are configured as holes in tissue contacting surface 540 (see <figref idref="f0007">FIG. 7</figref>). Each slot 528 is configured to receive a staple 530 therein. Cartridge 518 also defines a plurality of cam wedge slots 529 (see <figref idref="f0009">FIG. 9</figref>) which accommodate staple pushers 532 and which are open on the bottom (i.e., away from tissue contacting surface 540) to allow a longitudinally curved actuation sled 536 to pass therethrough.

0043Staple cartridge 518 includes a central slot 526 that is curved with respect to the longitudinal axis A-A, and three curved rows of staple retention slots 528 positioned on each side of curved longitudinal slot 526 (see <figref idref="f0007">FIGS. 7</figref> and <figref idref="f0008">8</figref>). More specifically, actuation sled 536 passes through cam wedge slots 529 and forces staple pushers 532 towards respective staples 530. The staples are then forced out of their respective staple retention slots 528.

0044With reference to <figref idref="f0016">FIGS. 21 and 22</figref>, pushers 532 of the illustrated embodiments each engage two or more staples 530. Pushers 532 include a single distally-located triple pusher 532a (<figref idref="f0017">FIG. 23</figref>), a single proximally-located double pusher 532b (<figref idref="f0017">FIG. 24</figref>), and a series of triple pushers 532c (one triple pusher 532c is shown in <figref idref="f0017">FIG. 25</figref>) which extend between double pusher 532b and triple pusher 532a on each side of slot 526. In disclosed embodiments, portions of pushers 532a, 532b, 532c are curved, or the pusher plates that support the surgical staples are offset or angled with respect to one another. In certain embodiments, at least some of the pushers 532a, 532b, 532c include no curved surfaces and the pusher plates that support and drive the surgical staples are angled with respect to one another.

0045During operation of stapler 10, actuation of its movable handle 22 through successive strokes causes distal advancement of its drive bar 30 (a distal portion of which is illustrated in <figref idref="f0003">FIG. 2</figref>), such that drive bar 30 pushes a drive assembly 560 through cartridge 518. (Further details of how actuation of movable handle 22 causes distal advancement of drive bar 30 are explained in <patcit id="pcit0004" dnum="US6953139B"><text>U.S. Patent No. 6,953,139 to Milliman et al.</text></patcit>, which has been incorporated by reference herein.) The movement of drive assembly 560, and in particular, a dynamic clamping member 606 affixed thereto, moves a longitudinally curved actuation sled 536 (see <figref idref="f0015">FIGS. 18-20</figref>) through cartridge 518. As sled 536 moves through cartridge 518, longitudinally curved cam wedges 534 of actuation sled 536 sequentially engage pushers 532 to move pushers 532 vertically within staple retention slots 528 and eject staples 530 into staple forming depressions 514 of anvil plate 512. Subsequent to the ejection of staples 530 from retention slots 528 (and into tissue), a cutting edge 606d of dynamic clamping member 606 severs the stapled tissue as cutting edge 606d travels through curved slot 526 of cartridge 518.

0046Referring to <figref idref="f0008">FIG. 8</figref> and in accordance with embodiments of the present disclosure, cartridge 518 includes a tissue contacting surface 540 including surfaces 540a, 540b, and 540c. Surface 540a is adjacent longitudinal slot 526 and defines a first gap between tissue contacting surface 540 and a bottom surface 544 of anvil plate 512. Surface 540b is located adjacent surface 540a and defines a second gap between tissue contacting surface 540 and bottom surface 544. Surface 540c is located proximal to an outer perimeter of cartridge 518 and defines a third gap between tissue contacting surface 540 and bottom surface 544. The first gap is less than the second gap, which is less than the third gap. When anvil 506 is approximated towards cartridge 508, layers of tissue located between bottom surface 544 and tissue contacting surface 540 are compressed. Since the first gap is the smallest, tissue located between surface 540a and bottom surface 544 is compressed the most. Similarly, the tissue located between surface 540c and bottom surface 544 is compressed the least, with the tissue located between surface 540b and bottom surface 544 being compressed to an intermediate degree. The arrangement of surfaces 540a, 540b, 540c on tissue contacting surface 540 provides a tissue compression gradient extending transverse to a longitudinal axis of the cartridge 518.

0047Referring to <figref idref="f0008">FIGS. 8</figref>, <figref idref="f0016">21 and 22</figref> in conjunction with the stepped arrangement of tissue contacting surface 540, the illustrated embodiment of staples 530 include varying leg lengths for cooperating with the varying gaps. Staples 530a have the shortest leg length and are associated with surface 540a. Similarly, staples 530b have an intermediate leg length and are associated with surface 540b, while staples 530c have the longest leg length and are associated with surface 540c. The leg length of staples 530b is between the leg length of staples 530a and 530c. Since the tissue between surface 540a and bottom surface 544 has been compressed the most, the resulting thickness of the tissue is at a minimum, thereby allowing a staple having a shorter leg length (i.e. staple 530a) to be used to join the layers of tissue. The layers of tissue between surface 540b and bottom surface 544 are compressed to an intermediate degree of compression and the resulting thickness of the tissue layers allows a staple having an intermediate leg length (i.e. staple 530b) to be used when joining the layers of tissue. The layers of tissue between surface 540c and bottom surface 544 are compressed the least amount and are thicker than the other layers requiring staples that have the longest leg length (i.e. staples 530c) for joining the layers of tissue.

0048In particular, the illustrated embodiment of pusher 532 includes plates 53 1 a, 531 b, 531c, which cooperate with staples 530a, 530b, 530c, respectively. Plate 531a has a height which is greater than the height of plate 531b. Additionally, the height of plate 531b is greater than the height of plate 531c. Pusher 532 further includes cam members 542 that are longitudinally staggered. As sled 536 translates distally through cartridge 518, cam wedges 534 engage cam members 542 of pusher 532, thereby urging pusher 532 in a direction transverse to the longitudinal axis of cartridge 518 and urging staples 530 towards staple forming depressions 514 of anvil plate 512. In particular, cam wedges 534 are longitudinally staggered such that when they engage staggered cam members 542, the resulting forces applied to move pusher 532 towards tissue contacting surface 540 are evenly applied.

0049With continued reference to <figref idref="f0016">FIGS. 21 and 22</figref>, staples 530a, 530b, 530c ride on pusher 532 (for illustrative purposes, pusher 532c from <figref idref="f0017">FIG. 25</figref> is shown). Additionally, cam members 542 of each pusher 532 include cam surfaces 542a and 542b. Each cam surface 542a, 542b is configured to be contacted by cam wedges 534. In particular, and with reference to <figref idref="f0016 f0017">FIGS. 21-25</figref>, cam wedges 534a are configured to cam surfaces 542a; cam wedges 534b are configured to engage cam surfaces 542b; central section 534c of sled 536 is configured to travel through slot 526.

0050Referring to <figref idref="f0015">FIG. 20</figref>, the illustrated embodiment of actuation sled 536 includes a curved projection 535 depending from a lower surface thereof. Projection 535 is configured to travel within a slot 515 (<figref idref="f0010">FIG. 10</figref>) of carrier 516.

0051With reference to <figref idref="f0010">FIG. 10</figref>, proximal body portion 502 includes an inner body 503 formed from molded half-sections 503a and 503b, a drive assembly 560 and a drive locking assembly 564. Proximal body portion 502 is coupled to tool assembly 504 by a mounting assembly 570. Mounting assembly 570 has a pair of extensions 576 which extend into a proximal end of carrier 516. Each extension 576 has a transverse bore 578 which is aligned with a hole 580 in the cartridge 518 such that mounting assembly 570 is pivotally secured to cartridge 518 by pin 582. Mounting assembly 570 is fixedly secured to half-section 503a by a pair of vertical protrusions 584. Vertical protrusions 584 extend upwardly from mounting assembly 570 and frictionally fit into corresponding recesses (not shown) in half-section 503a.

0052With continued reference to <figref idref="f0010">FIG. 10</figref>, the illustrated embodiment of anvil cover 510 includes a proximally extending finger 588 having a pair of cutouts 590 formed therein. Cutouts 590 are positioned on each lateral side of finger 588 to help secure anvil cover 510 to half-section 503a. More particularly, half-section 503a includes a channel 505 therein, and channel 505 includes a pair of protrusions 505a. Finger 588 of anvil cover 510 mechanically engages channel 505 of half-section 503a, such that cutouts 590 are aligned with protrusions 505a. An outer sleeve 602 covers the finger and channel. The configuration of finger 588 and channel 505 facilitates a secure connection between anvil cover 510 and half-section 503a. Moreover, this connection results in a non-movable (e.g., non-pivotable) anvil assembly 506 with respect to proximal body portion 502.

0053Referring to <figref idref="f0011 f0012">FIGS. 11-13</figref>, drive assembly 560 includes a flexible drive beam 604 which is constructed from three stacked metallic sheets 604 a-c and a proximal engagement portion 608. At least a portion of drive beam 604 is sufficiently flexible to be advanced through the curvature of the tool assembly 504. Drive beam 604 has a distal end which is secured to a dynamic clamping member 606 via a butt weld 606f (<figref idref="f0011">FIG. 12</figref>), spot weld, adhesive, joint or other connection. Spot welds 606h, which are configured to hold sheets 604 a-c together, are also shown in <figref idref="f0011">FIG. 12</figref>.

0054Engagement section 608 is fastened to a proximal portion of middle sheet 604b (e.g., via a butt weld) and includes a stepped portion defining a shoulder 610. A proximal end of engagement section 608 includes diametrically opposed inwardly extending fingers 612. Fingers 612 engage a hollow drive member 614 to fixedly secure drive member 614 to the proximal end of beam 604. Drive member 614 defines a proximal porthole 616 which receives the distal end of a control rod of drive bar 30 (see <figref idref="f0003">FIG. 2</figref>) when DLU 500 is attached to surgical stapling instrument 10.

0055With reference to <figref idref="f0013 f0014">FIGS. 14-17</figref>, dynamic clamping member 606 includes a vertical strut or vertical portion 606a, an upper beam 606b and a lower beam 606c. A knife or cutting edge 606d is formed on a distal face of vertical strut 606a. As illustrated, the width of vertical strut 606a is equal to the width of drive beam 604 of drive assembly 560 (see <figref idref="f0011">FIG. 12</figref>). With particular reference to <figref idref="f0013">FIG. 16</figref>, vertical strut 606a and knife 606d are longitudinally curved from a first lateral side 606e of clamping member towards a second lateral side 606f of clamping member 606. Both upper beam 606b and lower beam 606c are linearly disposed with respect to longitudinal axis "A-A."

0056As illustrated in <figref idref="f0013 f0014">FIGS. 14-17A</figref>, the present disclosure includes embodiments of dynamic clamping member 606 that are asymmetrical. For instance, in the embodiment illustrated in <figref idref="f0013">FIGS. 15 and 17</figref>, lower beam 606c larger in height than upper beam 606b. In this embodiment, dynamic clamping member 606 is asymmetrical about horizontal axis "H-H" extending through the center of the vertical portion or strut, as illustrated in <figref idref="f0013">FIG. 17</figref>. It is envisioned that lower beam 606c includes a height "T_L". It is envisioned that upper beam 606b includes a height "T_U".

0057An additional example of an asymmetrical dynamic clamping member 606 is also illustrated in <figref idref="f0013">FIG. 17</figref>. In this embodiment, the transverse cross-sectional shape of upper beam 606b includes an upper planar surface 606b1 and a lower planar surface 606b2. The cross-sectional shape of lower beam 606c includes an upper planar surface 606c 1 and a lower arcuate surface 606c2. In this embodiment, dynamic clamping member 606 is asymmetrical about the horizontal axis "H-H."

0058The embodiment shown in <figref idref="f0013">FIGS. 16 and 17</figref> illustrates distal portion of vertical portion or strut 606a being off-center with respect to the remainder of clamping member 606 so that the cutting edge faces off-center with respect to an axis B-B through the clamping member 606. In certain embodiments, the upper beam and lower beam are polygonal in shape and not curved. For example, the upper beam and lower beam can be rectangular, as seen in <figref idref="f0013">FIG. 16</figref>. In other embodiments, the upper beam and/or lower beam can be formed from a pin or roller mounted in the vertical portion. In this embodiment, dynamic clamping member 606 is asymmetrical about vertical axis "V-V" illustrated in <figref idref="f0013">FIG. 17</figref>.

0059With reference to <figref idref="f0014">FIG. 17A</figref>, dynamic clamping member 606' is shown. Lower beam 606c' is wider than upper beam 606b' of dynamic clamping member 606'. More particularly, it is envisioned that a width "wl" of lower beam 606c' is between about 0.180 inches and about 0.200 inches, and that a width "wu" of upper beam 606b' is between about 0.160 inches and about 0.180 inches. In this embodiment, dynamic clamping member 606' is asymmetrical about the horizontal axis "H-H." Further, while not explicitly shown, it is envisioned that upper beam 606b' is wider than lower beam 606c' of a dynamic clamping member 606 of the present disclosure. Additionally, dynamic clamping member 606' is shown as being longitudinally linear (vis-à-vis longitudinally curved), in accordance with embodiments of the present disclosure.

0060The asymmetrical embodiments of dynamic clamping member 606 of the present disclosure help ensure proper orientation of dynamic clamping member 606 during assembly of surgical stapling instrument 10 or DLU 500. That is, the asymmetry of dynamic clamping member 606 prevents dynamic clamping member 606 from improper placement with respect to tool assembly 504, since dynamic clamping member 606 can only physically fit in a particular orientation. In particular, the asymmetry ensures that knife 606d faces distally and is positioned to travel through the space between cartridge assembly 508 and anvil assembly 506, for example.

0061With reference to <figref idref="f0014">FIG. 17B</figref>, the present disclosure includes another embodiment of a dynamic clamping member 606" that is also configured to help ensure proper orientation of dynamic clamping member 606" during assembly of surgical stapling instrument 10 or DLU 500. Dynamic clamping member 606" includes a protrusion 607 extending from a proximal surface 606i thereof. In the illustrated embodiment, a drive assembly 560" has a smaller height than embodiment of drive assembly 560' illustrated in <figref idref="f0010 f0011 f0012">FIGS. 10-13</figref>. Protrusion 607 is shown being disposed on a lower portion of dynamic clamping member 606" (i.e., on the opposite side as cutting edge 606d") and to one side of drive assembly 560", but it is envisioned that protrusion 607 is disposed on the other side of drive assembly 560".

0062As discussed above, the inclusion of protrusion 607 helps ensure proper orientation of dynamic clamping member 606". More particularly, it is envisioned that extensions 576 of mounting assembly 570 would physically prevent further assembly of dynamic clamping member 606" being incorrectly fastened to drive assembly 560" (e.g., when dynamic clamping member 606" is up-side-down with respect to drive assembly 560".

0063It is further envisioned that dynamic clamping member 606, 606' may include any combination of the asymmetrical features discussed herein and may also include protrusion 607 of dynamic clamping member 606".

0064With additional reference to dynamic clamping member 606 of <figref idref="f0013 f0014">FIGS. 14-17A</figref>, it is envisioned that each of upper beam 606b and 606c includes a plastic material or layer which is injection molded onto an outwardly facing surface of each beam 606b and 606c. Plastic layer provides reduced frictional engagement between dynamic clamping member 606 and cartridge and anvil assemblies 508 and 506, respectively, during actuation of tool assembly 504.

0065Referring back to <figref idref="f0008">FIG. 8</figref>, channel 511 is configured and dimensioned accordingly to accommodate a corresponding embodiment of upper beam 606b of clamping member 606; slot 526 is configured and dimensioned accordingly to accommodate a corresponding embodiment of vertical strut 606a of clamping member 606. As can be appreciated, when used with the embodiment of dynamic clamping member 606 of <figref idref="f0014">FIG. 17A</figref>, channel 511 is too narrow to accommodate lower beam 606c of dynamic clamping member 606.

0066With reference to <figref idref="f0010">FIG. 10</figref>, when drive assembly 560 is advanced distally within tool assembly 504, upper beam 606b moves within channel 511 defined between anvil plate 512 and anvil cover 510, and lower beam 606c moves over an exterior surface of carrier 516. When lower beam 606c engages and moves over cam surface 516a, cartridge assembly 508 pivots from the open position to the closed position. As dynamic clamping member 606 continues to move distally along and through tool assembly 504, the maximum gap between anvil plate 512 and cartridge 518 is defined by engagement of layer 606e on upper beam 606b (<figref idref="f0011">FIG. 12</figref>) and a lower surface defining channel 511, and engagement of a layer 606g on lower beam 606c with the external surface of carrier 516. In disclosed embodiments, the height of channel 511 is greater than the height of upper beam 606b, providing clearance between the upper surface of dynamic clamping member 606 and the anvil plate 512 so that upper beam 606b of dynamic clamping member 600 does not simultaneously engage the upper and lower surfaces of anvil channel 511.

0067With continued reference to <figref idref="f0010">FIG. 10</figref>, DLU 500 includes a locking mechanism 564 including a locking member 620 and a locking member actuator 622. Locking member 620 is rotatably supported within a longitudinal or axial slot 625 formed in a proximal portion of an upper housing half 503a of inner body 503 of DLU 500. Locking member 620 is movable from a first position, in which locking member 620 maintains drive assembly 560 in a prefired position, to a second position in which drive assembly 560 is free to move axially.

0068Locking member 620 includes a semi-cylindrical body 624 which is slidably positioned within transverse slot 625 formed in upper housing half 503a of body portion 503. Body 624 includes a radially inwardly extending cam member 628 and a radially inwardly extending finger 630. Finger 630 is dimensioned to be received within a notch 632 formed in drive assembly 560. Engagement of finger 630 in notch 632 of drive assembly 560 prevents drive assembly 560 from moving linearly within body portion 503 to prevent actuation of DLU 500 prior to attachment of DLU 500 to surgical instrument 10.

0069Locking member actuator 622 is slidably positioned within axial slot 625 formed in upper housing half section 503a of body portion 503 of DLU 500. Actuator 622 includes a proximal abutment member 636, a distal spring guide 627, and a central cam slot 640. Axial slot 641 in the housing half section 503a intersects transverse slot 625 such that cam member 628 of locking member 620 is slidably positioned within cam slot 640 of locking member actuator 622. A biasing member or spring 642 is positioned about spring guide 627 between a distal surface of actuator 622 and a wall 641a defining the distal end of axial slot 641. Spring 642 urges actuator 622 to a first position within axial slot 641. In the first position, abutment member 636 is positioned on insertion tip 650 of proximal body portion 502 (<figref idref="f0004">FIG. 3</figref>) and cam slot 640 is positioned to locate cam member 628 such that finger 630 of lock member 620 is positioned within notch 632 of drive assembly 560.

0070Prior to attachment of DLU 500 onto surgical instrument 10, spring 642 urges actuator 622 to the first position to maintain the lock member 620 in its first position as discussed above. When insertion tip 650 of DLU 500 is linearly inserted into the open end of the body portion 18 (<figref idref="f0003">FIG. 2</figref>) of surgical instrument 10, nubs 652 of insertion tip 650 (<figref idref="f0004">FIG. 3</figref>) move linearly through slots (not shown) formed in open end of body portion 18. As nubs 652 pass through the slots, the proximal end of abutment member 636, which is angularly offset from nubs 652, abuts a wall defining the slots for receiving nubs. As DLU 500 is moved farther into body portion, locking member actuator 622 is moved from its first position to its second position. As actuator 622 is moved to its second position, lock member 620 is cammed from its first position engaged with notch 632 of drive assembly 560 to its second position to move finger 630 from notch 632. The locking mechanism including locking member 620 and locking member actuator 622 prevents advancement of the drive assembly 560 of DLU 500 prior to loading of DLU 500 onto a surgical instrument 10.

0071In the embodiments illustrated in <figref idref="f0004">FIGS. 3</figref> and <figref idref="f0010">10</figref>, locking member actuator 622 includes an articulation lock portion 637 disposed thereon. In particular, articulation lock portion 637 extends in an approximate right angle from abutment member 636. Articulation lock portion 637 is configured to physically prevent the longitudinal translation of an articulation member (not shown) of a handle portion of a surgical instrument having articulation capabilities. That is, even when DLU 500 is engaged with a surgical instrument 10 that is otherwise capable of articulation (i.e., pivotable movement of the jaw members with respect to the elongated portion 18), articulation lock portion 637 of DLU 500 prevents an articulation member from entering DLU 500.

0072Referring to <figref idref="f0010">FIG. 10</figref>, upper half-section 503a of proximal body portion 502 defines a longitudinal slot 660 which receives a leaf spring 662. Leaf spring 662 is confined within slot 660 by outer sleeve 602. Leaf spring 662 has an angled proximal end 664 which is positioned to abut shoulder 610 (<figref idref="f0011">FIG. 11</figref>) of engagement section 608 of drive beam 604 when drive beam 604 is in its retracted position. When drive beam 604 is advanced distally by advancing drive bar 30, as described above, leaf spring 662 is flexed upwardly by shoulder 610 of drive beam 604 to permit distal movement of drive beam 604.

0073Referring to <figref idref="f0005">FIGS. 4</figref>, <figref idref="f0007">7</figref>, and <figref idref="f0018 f0019 f0020">26-30</figref>, DLU 500 also includes a tissue stop 700. Tissue stop 700 includes a body 710, a pair of legs 720 extending proximally from the body 710, a stopping portion 730, a pair of laterally opposed protrusions 740 extending transversely from body 710 (See <figref idref="f0018">FIG. 26</figref>), and a knife channel 750 disposed between pair of legs 720. Tissue stop 700 is pivotally connected to a distal portion of cartridge assembly 508 via the engagement between protrusions 740 and a corresponding pair of apertures (not shown) disposed within cartridge assembly 508. Cartridge assembly 508 includes an opening 519 (<figref idref="f0007">FIGS. 7</figref> and <figref idref="f0010">10</figref>) adapted to receive both legs 720 of tissue stop 700. A recess 521 is positioned distally of opening 519 and is adapted to receive a portion of tissue stop 700 therein. The recess 521 and opening 519 are shown in <figref idref="f0010">FIG. 10</figref>.

0074Tissue stop 700 is movable between a first position (<figref idref="f0005">FIG. 4</figref>), which corresponds to when the jaw members are in an open position where an upper surface 701 thereof is disposed between cartridge assembly 508 and anvil assembly 506 (<figref idref="f0005">FIG. 4</figref> illustrates the jaw members in a partially approximated position; <figref idref="f0006">FIG. 6</figref> illustrates the jaw members in a fully opened position), and a second position (<figref idref="f0020">FIG. 30</figref>), which corresponds to when the jaw members are in the approximated position and where upper surface 701 of tissue stop 700 is substantially flush with tissue contacting surface 514 of cartridge 518. (In <figref idref="f0020">FIG. 30</figref>, upper surface 701 is hidden as upper surface 701 is within cartridge assembly 508.) A biasing member 760 (<figref idref="f0010">FIG. 10</figref>), a portion of which is disposed around protrusion 740, urges tissue stop 700 towards its first position. Tissue stop 700 also includes a finger 770 (<figref idref="f0018">FIG. 26</figref>) extending distally from each leg 720. With specific reference to <figref idref="f0018">FIG. 27</figref>, when the jaw members are in the open position, fingers 770 of tissue stop 700 engage a lip 523 disposed on cartridge assembly 508 to limit the amount of movement imparted by biasing member 760 in the general direction of arrow "B" in <figref idref="f0018">FIG. 27</figref>.

0075When tissue stop 700 is in its first position, tissue "T" is proximally insertable (in the general direction of arrow "A" in <figref idref="f0019">FIG. 28</figref>) from distally beyond tissue stop 700, to a location that is between anvil assembly 206 and cartridge assembly 508 and proximal of tissue stop 700 (see <figref idref="f0019">FIGS. 28 and 29</figref>). In this position, stopping portion 730, which is disposed at an oblique angle (e.g., between about 45° and about 90°) with respect to tissue contacting 540 of cartridge assembly 508, impedes tissue from distally escaping the tool assembly 504. When the jaw members are approximated (e.g., when cartridge assembly 508 is pivoted towards anvil assembly 506), tissue stop 700 (or tissue "T") contacts anvil assembly 506, thus causing tissue stop 700 to pivot from its first position towards its second position. Legs 720 of tissue stop 700 are configured to lie within opening 519 (i.e., equal to or below the tissue contacting surface 540) of cartridge assembly 508 when tissue stop 700 is in its second position, such that legs 720 do not interfere with the location of the tissue with respect to the cartridge assembly 508 and respect to anvil assembly 506 (i.e., so that the staples can be deployed into tissue lying over the tissue stop). When the cartridge assembly 508 moves away from anvil assembly 506, tissue stop 700, under the influence of biasing member 760, returns to its first position.

0076With additional regard to knife channel 750, knife channel 750 is configured to allow vertical strut 606a (including cutting edge 606d) of dynamic clamping member 606 to travel distally past a portion of tissue stop 700 (i.e., at least to a location adjacent the distal-most longitudinal slot 528). Additionally, it is envisioned that at least a portion of knife channel 750 (e.g., the portion that is contacted by cutting edge 606d) is over molded with plastic or another suitable material, or the knife channel 750 has disposed therein a material for receiving the knife blade as the knife reaches the end of its travel during the operation of the instrument.

0077While not explicitly illustrated, it is also envisioned that tissue stop 700 is usable with a surgical instrument having parallel jaws and/or an electrosurgical instrument. An example of a surgical instrument having parallel jaws is described in commonly-owned <patcit id="pcit0005" dnum="US7237708B"><text>U.S. Pat. No. 7,237,708 to Guy et al.</text></patcit>, the entire contents of which are hereby incorporated by reference herein. An example of an electrosurgical instrument is described in commonly-owned Patent Application No. <patcit id="pcit0006" dnum="US10369894B"><text>10/369,894, filed on February 20, 2003</text></patcit>, entitled VESSEL SEALER AND DIVIDER AND METHOD OF MANUFACTURING THE SAME, the entire contents of which are hereby incorporated by reference herein.

0078The present disclosure also relates methods of using the described surgical instrument 10 or DLU 500 to perform a lower anterior resection. Such a method includes providing surgical instrument 10 or DLU 500, positioning jaw members adjacent tissue, and approximating one jaw member (e.g., cartridge assembly 508) with respect to the other jaw member (e.g., anvil assembly 506). The drive assembly 560 is advanced incrementally such that dynamic clamping member 606 and at least a portion of drive assembly 560 move along a curvilinear path an incremental distance for each stroke of the movable handle. The drive assembly 560 moves distally to cause staples 530 to be ejected into tissue "T" and to cut tissue "T." In other embodiments, the drive assembly is moved the length of the jaws of the instrument in one stroke. In other embodiments, the instrument is operated by motor or pneumatic power, rather than by manual power. In certain embodiments, the jaw members are approximated, and the interior of the intestinal tissue is then washed out or otherwise cleansed. The tissue is then cut and stapled. In this way, the interior intestinal tissue is cleansed up to the location of the jaw members. A clamp may be used to isolate a portion of the intestine for cleaning, and the clamp may comprise a separate instrument, or may be incorporated in the surgical stapling instrument or loading unit.

0079The present disclosure also relates to methods of assembling surgical instrument 10 or DLU 500. Such a method includes positioning asymmetrical dynamic clamping member 606, 606' in mechanical engagement with a portion of tool assembly 504, and wherein the positioning step automatically results in the proper positioning of asymmetrical dynamic clamping member 606. In another embodiment, the clamping member is positioned with respect to the anvil assembly and the fit of the clamping member with the anvil assembly is determined. If the clamping assembly does not initially fit, the clamping assembly is rotated 180 degrees. Another method includes attaching dynamic clamping member 606" to drive assembly 560" in a way that would enable fail-safe positioning of dynamic clamping member 606" with respect to tool assembly 504.

0080In certain embodiments of the present disclosure, a surgical stapling instrument as discussed above has a replaceable cartridge rather than a replaceable loading unit with a complete tool assembly having a pair of jaws. The jaws of the surgical stapling instrument are attached to the endoscopic portion and handle and include a channel for receiving the replaceable cartridge. The cartridge is an assembly having a tissue stop incorporated with the cartridge assembly. The tissue stop may otherwise be as described above.

0081While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the present disclosure, but merely as illustrations of various embodiments thereof. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.