Surgical stapling and cutting instrument with articulatable end effector

[0001] The present invention relates in general to endoscopic surgical instruments including, but not limited to, surgical stapler instruments that are capable of applying lines of staples to tissue while cutting the tissue between those staple lines and, more particularly, to improvements relating to articulation joints used in connection with surgical stapler instruments with articulatable end effectors.

[0002] Endoscopic surgical instruments are often preferred over traditional open surgical devices since a smaller incision tends to reduce the post-operative recovery time and complications. Consequently, significant development has gone into a range of endoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.).

[0003] Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision. The end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument commonly includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil.

[0004] Examples of surgical staplers suitable for endoscopic applications are described in U.S. Pat. No. 6,905,057 to Jeffrey S. Swayze and Frederick E. Shelton, IV, entitled Surgical Stapling Instrument Incorporating a Firing Mechanism Having a Linked Rack Transmission and U.S. Pat. No. 7,083,075 to Jeffery S. Swayze, Frederick E. Shelton, IV, Kevin Ross Doll, and Douglas B. Hoffman entitled Multi-Stroke Mechanism With Automatic End of Stroke Retractions, the disclosures of which are herein incorporated by reference in their entireties.

[0005] Depending upon the nature of the operation, it may be desirable to further adjust the positioning of the end effector of an endoscopic surgical instrument. In particular, it is often desirable to orient the end effector at an angle relative to the longitudinal axis of the shaft of the instrument. The transverse or non-axial movement of the end effector relative to the instrument shaft is often conventionally referred to as “articulation”. This articulated positioning permits the clinician to more easily engage tissue in some instances, such as behind an organ. In addition, articulated positioning advantageously allows an endoscope to be positioned behind the end effector without being blocked by the instrument shaft.

[0006] Approaches to articulating a surgical stapling and severing instrument tend to be complicated by integrating control of the articulation along with the control of closing the end effector to clamp tissue and fire the end effector (i.e., stapling and severing) within the small diameter constraints of an endoscopic instrument. Generally, the three control motions are all transferred through the shaft as longitudinal translations. For instance, U.S. Pat. No. 5,673,840 to Schulze et al., the disclosure of which is herein incorporated by reference, discloses an accordion-like articulation mechanism (“flex-neck”) that is articulated by selectively drawing back one of two connecting rods through the implement shaft, each rod offset respectively on opposite sides of the shaft centerline. The connecting rods ratchet through a series of discrete positions.

[0007] Another example of longitudinal control of an articulation mechanism is U.S. Pat. No. 5,865,361 that includes an articulation link offset from a camming pivot such that pushing or pulling longitudinal translation of the articulation link effects articulation to a respective side. Similarly, U.S. Pat. No. 5,797,537 discloses a similar rod passing through the shaft to effect articulation. Still other examples of articulatable surgical stapling devices are disclosed in U.S. Pat. Nos. 6,250,532 and 6,644,532.

[0008] Due to the types end effector firing systems commonly employed, the actuator arrangements for articulating the end effector must often generate high amounts of torque to bend the firing structure. This problem is exacerbated by the lack of available space for accommodating actuating devices that are large enough to generated those required forces.

[0009] In an effort to address such challenges, surgical instruments with “passive articulation joints” have been developed. For example, U.S. Patent Publication No. US 2007/0027469 A1 to Kevin W. Smith, Matthew A. Palmer, Korey Robert Kline and Derek Dee Deville, the disclosure of which is herein incorporated by reference, discloses a medical device that employs a passive articulation joint. When actuated, the articulation joint is released into a freely articulating state to permit free articulation of the end effector with respect to the control handle dependent upon external forces acting upon the end effector.

[0010] While the above-mentioned medical device with a passive articulation arrangement effectively addresses various challenges encountered with active articulation arrangements, there is still a need for medical devices with improved passive articulation joint arrangements.

[0011] In one aspect of the invention, there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion and has a plurality of first planetary gear teeth formed thereon. The instrument may further comprise an end effector for performing a surgical operation. The end effector may have a plurality of second planetary gear teeth formed thereon. At least one pivot bar is pivotally coupled to the proximal frame portion and distal frame portion to retain the first gear teeth in permanent meshing orientation with the second gear teeth to facilitate pivotal travel of the end effector relative to the proximal frame portion.

[0012] In another general aspect of various embodiments of the present invention there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion. The instrument may further include an end effector for performing a surgical operation. At least two flexible bands are attached to the proximal frame portion and the end effector and extend therebetween such that at least one of the at least two flexible bands crosses another one of the at least two flexible bands.

[0013] In still another general aspect of various embodiments of the present invention there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion. The instrument may further include an end effector for performing a surgical operation. A series of interlocking flexible sockets are coupled to the proximal frame portion and the end effector and extend therebetween.

[0014] In another general aspect of various embodiments of the present invention there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion. The proximal frame portion may define a longitudinal axis. The instrument may further include an end effector for performing a surgical operation. At least two substantially rigid bars may be pivotally attached to the proximal frame portion and the end effector and extend therebetween such that one end of at least one of the rigid bars is attached to the proximal frame portion along the longitudinal axis.

[0015] In another general aspect of various embodiments of the present invention there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion. The proximal frame portion may define a longitudinal axis. The instrument may further include an end effector for performing a surgical operation that is coupled to the proximal frame portion by an articulation joint. The articulation joint may include first and second arcuate slots in one of the end effector and the proximal frame portion. Each arcuate slot is oriented to slidably receive therein a corresponding pin that protrudes from the other of the end effector and proximal frame portion to facilitate pivotal travel of the end effector relative to the proximal frame portion about a pivot axis that is substantially transverse to the longitudinal axis.

[0016] In another general aspect of various embodiments of the present invention there is provided a surgical instrument that may include a handle portion and a proximal frame portion that is coupled to the handle portion. The proximal frame portion may define a longitudinal axis. The instrument may further include an end effector for performing a surgical operation that is coupled to the proximal frame portion by an articulation joint. The articulation joint may include a concave surface defining a bowl on one of the proximal frame portion and the end effector. A convex surface may be formed on the other of the proximal frame portion and the end effector and be in confronting relationship with the concave surface to define a pivot axis extending through the convex and concave surfaces about which the end effector may pivot relative to the proximal frame portion such that the end effector can only pivot in one plane that is substantially perpendicular to the pivot axis.

[0017] These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.

[0034] Turning to the Drawings, wherein like numerals denote like components throughout the several views, FIG. 1 depicts a surgical instrument, which in the illustrative versions is more particularly a surgical stapling and severing instrument 10, capable of practicing the unique benefits of the present invention. In particular, the surgical stapling and severing instrument 10 is sized for insertion, in a nonarticulated state as depicted in FIG. 1, through a trocar cannula passageway to a surgical site in a patient (not shown) for performing a surgical procedure. An end effector, depicted in the illustrative version as a staple applying assembly 20, is distally attached to a shaft portion 16 by an articulation joint 100. After the staple applying assembly 20 has been inserted through the trocar cannula passageway, the clinician can move the staple applying assembly 20 to a desired articulated orientation by “passively” bringing the staple applying assembly 20 into contact with the organ or other portion of the body or another medical instrument to apply an external force to the staple applying instrument 20 to cause it to articulate as will be discussed in further detail below. Such an angled position may have advantages in approaching tissue from a desired angle for severing and stapling, approaching tissue otherwise obstructed by other organs and tissue, and/or allowing an endoscope to be positioned behind and aligned with the staple applying assembly 20 for confirming placement.

[0035] The surgical and stapling and severing instrument 10 may include a handle portion 22 proximally connected to the implement portion 12 for providing positioning, articulation, closure and firing motions thereto. The handle portion 22 may include a pistol grip 24 toward which a closure trigger 26 is pivotally and proximally drawn by the clinician to cause clamping, or closing, of the staple applying assembly 20. A firing trigger 28 may be positioned further outboard of the closure trigger 26 and is capable of being pivotally drawn by the clinician to cause the stapling and severing of tissue clamped in the staple applying assembly 20. Thereafter, a closure release button 30 is depressed to release the clamped closure trigger 26, and thus the severed and stapled ends of the clamped tissue. The handle portion 22 also includes a rotation knob 32 coupled for movement with the elongate shaft 16 to rotate the shaft 16 and the articulated staple applying assembly 20 about the longitudinal axis of the shaft 16. The handle portion 22 also includes a firing retraction handle 34 to assist in retracting a firing mechanism (not depicted in FIG. 1) should binding occur, so that opening of the staple applying assembly 20 may occur thereafter.

[0036] It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping a handle of an instrument. Thus, the surgical stapling assembly 20 is distal with respect to the more proximal handle portion 22. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0037] An illustrative multi-stroke handle portion 22 for the surgical stapling and severing instrument 10 of FIGS. 1-2 is described in greater detail in the following co-pending and commonly-owned U.S. patent applications, the disclosures of which are herein incorporated by reference, with additional features and variations as described herein:

[0038] (1) U.S. Patent Publication No. US 2006/0289602A1 to Kenneth S. Wales and Eugene L. Timperman, entitled “Surgical Instrument With Articulating Shaft With Double Pivot Closure And Single Pivot Frame Portion;

[0039] (2) U.S. Patent Publication No. US 2006/0190029A1 to Kenneth S. Wales, entitled “Surgical Instrument With Laterally Moved Shaft Actuator Coupled to Pivoting Articulation Joint;

[0040] (3) U.S. Patent Publication No. US 2006/0190031 A1 to Kenneth S. Wales and Cad P. Boudreaux, entitled “Surgical Instrument With Articulating Shaft With Rigid Firing Bar Supports”; and.

[0041] (4) U.S. Publication No. 20050070958 A1 to Swayze and Shelton IV, entitled “Surgical Stapling Instrument Incorporating a Multistroke Firing Position Indicator and Retraction Mechanism”.

[0042] While a multi-stroke handle portion 22 advantageously supports applications with high firing forces over a long distance, applications consistent with the present invention may incorporate a single firing stroke, such as described in co-pending and commonly owned U.S. Pat. No. 7,000,818, entitled “Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems” to Frederick E. Shelton IV, Michael E. Setser, and Brian J. Hemmelgarn, the disclosure of which is hereby incorporated by reference in its entirety.

[0043] In FIGS. 2 and 3, the implement portion 12 may advantageously incorporate the multiple actuation motions of longitudinal rotation, articulation, closure and firing within a small diameter suitable for endoscopic and laparoscopic procedures. The staple applying assembly 20 (“end effector”) has a pair of pivotally opposed jaws, depicted as an elongate channel 40 with a pivotally attached anvil 42 (FIGS. 1 and 3). Closure and clamping of the anvil 42 to the elongate channel 40 is achieved by longitudinally supporting the elongate channel 40 with a frame assembly 44 (FIG. 2) rotatingly attached to the handle portion 22 over which a double pivot closure sleeve assembly 46 longitudinally moves to impart closing and opening motions respectively to the anvil 42, even with the staple applying assembly 20 articulated.

[0044] With particular reference to FIG. 2, the frame assembly 44 may include a single pivot frame portion 48 whose proximal end is engaged to the rotation knob 32, with a right half shell 50 thereon shown in FIG. 2. It should be appreciated that a proximal end of the closure sleeve assembly 46, specifically of closure straight tube 52, encompasses the proximal end of the frame portion 48, passing further internally to the handle portion 22 to engage closure components (not shown) that longitudinally translate the closure sleeve assembly 46. A circular lip 54 at the proximal end of the closure straight tube 52 provides a rotating engagement to such components. Engaging components of the rotation knob 32 pass through a longitudinal slot 56 on a proximal portion of the straight closure tube 52 to engage an aperture 58 proximally positioned on the frame portion 48. The longitudinal slot 56 is of sufficient length to allow the closure longitudinal translation of the closure sleeve assembly 46 at various rotational angles set by the rotation knob 32 to the closure sleeve assembly 46 and the frame portion 48.

[0045] The elongate shaft 16 supports the firing motion by receiving a firing rod 60 that rotatingly engages firing components of the handle portion 22 (not shown). The firing rod 60 enters a proximal opening 62 along the longitudinal centerline of the frame portion 48. The distal portion of the frame portion 48 includes a firing bar slot 64 along its bottom that communicates with the proximal opening 62. A firing bar 66 longitudinally translates in the firing bar slot 64 and includes an upwardly projecting proximal pin 68 that engages a distal end 70 of the firing rod 60.

[0046] With particular reference to FIG. 3, the articulation joint 100 may include a distal closure tube segment 116 that may be constructed as shown for enhanced manufacturability and may include a short closure tube 146 that is attached to an articulating attachment collar 148 that may include proximally projecting pivot tabs 126, 128. Similarly, the straight closure tube 52 may be assembled from a long closure tube segment 150 that attaches to an aft attachment collar 152 that may include the distally projecting pivot tabs 119, 120. The horseshoe aperture 118 in the short tube 146 is designed to engages an upwardly projecting anvil feature 154 that is slightly proximal to lateral pivot pins 156 that engage pivot recesses 158 inside of the elongate channel 40. See FIG. 3.

[0047] In various embodiments, the firing bar 66 may distally terminate in an E-beam 165 that includes upper guide pins 166 that enter an anvil slot 168 in the anvil 42 to verify and assist in maintaining the anvil 42 in a closed state during staple formation and severing. See FIG. 3. Spacing between the elongate channel 40 and anvil 42 may be further maintained by the E-beam 165 by having middle pins 170 slide along the top surface of the elongate channel 40 while a bottom foot 172 opposingly slides along the undersurface of the elongate channel 40, guided by a longitudinal opening 174 in the elongate channel 40. A distally presented cutting surface 176 of the E-beam 165, which is between the upper guide pins 166 and middle pin 170, severs clamped tissue while the E-beam actuates a replaceable staple cartridge 178 by distally moving a wedge sled 180 that causes staple drivers 182 to cam upwardly driving staples 184 out of upwardly open staple holes 186 in a staple cartridge body 188, forming against a staple forming undersurface 190 of the anvil 42. A staple cartridge tray 192 encompasses from the bottom the other components of the staple cartridge 178 to hold them in place. The staple cartridge tray 192 includes a rearwardly open slot 194 that overlies the longitudinal opening 174 in the elongate channel 40, thus the middle pins 170 pass inside of the staple cartridge tray 192. One form of a and end effector or staple applying assembly that may be employed is described in greater detail in co-pending and commonly-owned U.S. Patent Publication No. 20070084897 A1, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism” to Frederick E. Shelton IV, et al., the disclosure of which is hereby incorporated by reference in its entirety.

[0048] With reference to FIGS. 2-4, the articulation joint 100 may advantageously incorporate the double pivot closure sleeve assembly 46 described above. One exemplary arrangement of these mechanisms and their operation will now be described in further detail. In various embodiments, for example, the distal end 49 of the proximal frame portion 48 may be provided with a downwardly facing concave lower surface 200 that is adapted to receive a correspondingly shaped convex surface 204 on the distal frame member 114. Those of ordinary skill in the art will appreciate that, in an alternative embodiment, the concave surface may be provided on the distal frame member 114 and the convex surface may be formed on the proximal frame portion 48 without departing from the spirit and scope of the present invention.

[0049] Such joint arrangement 100 facilitates pivotal travel of the distal frame member 114 relative to the proximal frame portion 48 around a pivot axis, generally referenced as axis A-A in FIG. 4 such that the distal frame member 114 (and staple applying assembly 20) is generally pivotable about axis A-A in a plane “P-P” in which the proximal frame portion 48 also lies. As shown in FIG. 4, axis A-A is substantially perpendicular to a plane P-P. Stated another way, such arrangement of concave and convex surfaces 200, 204 restricts rotation of the distal frame member 114 about pivot axis A-A relative to the proximal frame portion 48 within a common plane of rotation P-P. Thus, this joint arrangement does not enable the distal frame member 114 to pivot in a plane that is substantially different from a plane in which the proximal frame portion 48 lies. Such arrangement does, however, afford relatively easy pivoting and rotation of the staple applying assembly 20. When the closure sleeve assembly 46 is moved distally to pivot anvil 42 closed, the closure tube 52 moves distally about proximal frame portion 48 and the articulated distal closure tube segment 116 moves distally along the articulated distal frame member 114 as urged by pivot links 134, 140. Dual pivoting pins 136, 138 and 142, 144 on links 134, 140, respectively, facilitate engagement with closure tube 52 and articulated distal closure tube segment 116 as they are urged towards the distal closure position when the device is articulated (not shown).

[0050] In various embodiments, a dog bone link 160 may be employed and configured to provide support to the firing bar 66 which may be of flexible construction. The frame portion 48 may also include a frame knife slot (not shown) that runs along the bottom of frame portion 48 and a distal knife slot (not shown) that runs along the bottom of the distal frame member 114 for the sliding reception of the firing bar 66 (not shown) therein. The dog bone link 160 may be rotatably connected on proximal pin end 157 and movably connected on distal pin end 159 and include left and right lateral guides 1818, 1820, defining therebetween a guidance slot 1822 for sliding passage of a firing bar 66 (FIG. 5). Thus, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 is pivotally attached to frame portion 48 and slidingly attached to distal frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame member 114. Articulation of staple applying assembly 20 to an angle of such as 45 degrees from the longitudinal axis pivots pivoting dog bone 160 in bore 1824 at its proximal pin 157, and distal pin 157 slides in slot 1826 at its distal end 1814 to bend firing bar 66 to two spaced apart angles that are half of the angle of the staple applying assembly 20.

[0051] The distal frame member 114 can pivot relative to the proximal frame portion 48 about pivot axis A-A by virtue of the concave and convex surface arrangement. Those of ordinary skill in the art will understand that in various embodiments the friction between the surfaces 200 and 204 will serve to retain the distal frame member 114 (and the staple applying assembly 20) in the articulated position relative to the proximal frame portion 48 and additional clamping arrangements may be used to apply clamping forces thereto to retain those components in the desired articulated position. The end effector may be articulated by applying an articulation force thereto by bringing the end effector into contact with a portion of the patient's body or with another instrument which may also be inserted into the patient's body.

[0052] FIGS. 6 and 7 illustrate another articulation joint 300 that may be employed in connection with various embodiments of the present invention. This embodiment may be substantially identical in construction to the above-described embodiment, except for the following differences. For example, in this embodiment, the proximal end 115 of the distal frame member 114 may have two arcuate slots 310, 312 formed therein for receiving corresponding pins 320, 322 formed on the distal end 49 of the proximal frame portion 48. Thus, the distal frame member 114 is constrained to pivot relative to the frame portion 48 by the travel of the pins 320, 322 in their respective slots 310, 312 about pivot axis B-B that extends through the center 311 between the arcuate slots 310, 312. Pivot axis B-B may be substantially perpendicular to the longitudinal axis L-L of the proximal frame portion 48. This joint arrangement may also serve to restrict the pivotal travel of the distal frame member 114 about the pivot axis B-B such that the distal frame member 114 is substantially retained in the common plane of rotation P-P with the proximal frame portion 48. Those of ordinary skill in the art will appreciate that in alternative embodiments, the arcuate slots 310, 312 may be provided in the distal end 49 of the proximal frame portion 48 and the pins 320, 322 may be provided in the distal frame member 114 without departing from the spirit and scope of the present invention. In still other embodiments, the distal frame member 114 and the proximal frame portion 48 may each have one arcuate slot and one pin wherein the pin is oriented to be slidably received in the slot in the other part.

[0053] Also in these embodiments, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 may pivotally attached to frame portion 48 and slidingly attached to distal frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame 114. Articulation of staple applying assembly 20 to an angle of such as 45 degrees from the longitudinal axis pivots pivoting dog bone 160 in bore 1824 at its proximal pin 157, and distal pin 157 slides in slot 1826 at its distal end 1814 to bend firing bar 66 to two spaced apart angles that are half of the angle of the staple applying assembly 20. In various embodiments, a bellows-like sleeve or cover 350 made from an elastomeric or polymeric material may be positioned over the shaft to at the location of the articulation joint to prevent debris and fluids from entering the joint. See FIG. 6. The end effector may be articulated by applying an articulation force thereto by bringing the end effector into contact with a portion of the patient's body or with another instrument which may also be inserted into the patient's body.

[0054] FIGS. 8 and 9 illustrate another articulation joint 400 that may be employed in connection with various embodiments of the present invention. This embodiment may be substantially identical in construction to the above-described embodiments, except for the following differences. For example, this embodiment may employ a pair of substantially rigid linkage bars 410, 420 to pivotally interconnect the distal frame member 114 and the frame portion 48. As can be seen in FIG. 8, for example, the lower linkage bar 410 may have a distal pin portion 414 protruding from a distal end 412 thereof that is constructed to be received in a first hole 260 in the distal frame member 114. Distal frame member 114 may also be provided with an undercut portion 262 to accommodate the pivotal travel of the distal end 412 of the lower linkage bar 410 therein about a first pivot axis C-C defined by the distal pin 414 and hole 262. As can also be seen in FIG. 8, the proximal end 416 of the lower linkage bar 410 may have a proximal pin 418 protruding therefrom that is constructed to be received within a hole 264 in the distal end 49 of the frame portion 48. The proximal pin 418 and hole 264 also serve to define a second pivot axis D-D.

[0055] As indicated above, this embodiment may further comprise an upper linkage bar 420 that has a distal end 422 and a proximal end 426. A distal pin 424 protrudes from the distal end 422 and is constructed to be received in a second hole 266 in the distal frame member 114. The pin 424 and the hole 266 serve to define a third pivot axis E-E. A proximal pin 428 protrudes from the proximal end 426 of the upper linkage bar 420 and is constructed to be received in a second hole 268 in the distal end 49 of the frame portion 48. The proximal pin 428 and hole 268 serve to define a fourth pivot axis F-F. As can be seen in FIG. 8, the first axis C-C, the second axis D-D, the third axis E-E, and the fourth axis F-F may all be substantially transverse and perpendicular to the longitudinal axis L-L of the proximal frame portion 48. As can also be seen in FIG. 9, at least one of the pins 424, 428 lie along longitudinal axis L-L.

[0056] Also in this embodiment, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 may pivotally attached to frame portion 48 and slidingly attached to frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame 114. As can be seen in FIG. 8, the lower linkage bar 410 lies along a lower plane G-G and the upper linkage bar 420 lies along an upper plane H-H that is not coplanar with the lower plane G-G. Such arrangement enables the linkage bars 410, 420 to pivot to an axially aligned position wherein the shaft 16 can be inserted through a trocar passage (FIG. 1) and other non-axially aligned articulated positions (FIG. 9). In various embodiments, a bellows-like sleeve 450 made from an elastomeric or polymeric material may be positioned over the shaft to at the location of the articulation joint 400 to prevent debris and fluids from entering the joint. See FIG. 9. The end effector may be articulated by applying an articulation force thereto by bringing the end effector into contact with a portion of the patient's body or with another instrument which may also be inserted into the patient's body.

[0057] FIGS. 10 and 11 illustrate another articulation joint 500 that may be employed in connection with various embodiments of the present invention. This embodiment may be substantially identical in construction to the above-described embodiments, except for the following differences. For example, this embodiment may employ a series 510 of flexible interlocking sockets 512 for pivotally and rotatably interconnecting the distal frame member 114 and the frame portion 48. As can be seen in FIG. 10, for example, a proximal end of the series of flexible interlocking sockets may be attached to the distal end 49 of the frame portion 48. A distal end 514 of the series 510 may be attached to the proximal end 115 of the frame member 114. A tension cable 520 may be employed such that it extends from the handle portion (not shown) through the proximal closure tube segment 150 and is coupled to the frame member 114. When tension is applied to the cable 520, the sockets 512 interlock to retain the sockets 512 in the substantially locked position. To reposition the staple applying assembly 20, tension is relaxed on the cable 520 to thereby permit the application of an external force to the staple applying assembly 20 to enable it to be articulated and/or rotated to a desired orientation. Once the staple applying assembly 20 has been positioned in the desired orientation, tension is reapplied to the cable 520 to retain the interlocking sockets 512 in position.

[0058] Also in this embodiment, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 may pivotally attached to frame portion 48 and slidingly attached to frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame 114. In various embodiments, a bellows-like sleeve 550 made from an elastomeric or polymeric material may be positioned over the shaft to at the location of the articulation joint to prevent debris and fluids from entering the joint. See FIG. 10. The end effector may be articulated by applying an articulation force thereto by bringing the end effector into contact with a portion of the patient's body or with another instrument which may also be inserted into the patient's body.

[0059] FIGS. 12 and 13 illustrate another articulation joint 600 that may be employed in connection with various embodiments of the present invention. This embodiment may be substantially identical in construction to the above-described embodiments, except for the following differences. For example, in this embodiment, a first series of planetary-like gear teeth 610 may be formed on at least a portion of the circumference of the proximal end 115 of the frame member 114. Likewise a second series of planetary-like gear teeth 620 are formed on at least a portion of the circumference of the distal end 49 of the frame portion 48. The gear teeth 610 are retained in permanent meshing engagement with gear teeth 620 by a pivot bar 630 that pivotally interconnects the proximal end 115 of the frame member 114 with the distal end 49 of the frame portion 48. As can be seen in FIG. 12, a distal pin portion 634 protrudes from a distal end 632 of the pivot bar 630 and is constructed to be rotatably received in a hole 260 formed in the underside of the frame member 114. The frame member 114 may also have an undercut area 262 formed therein to accommodate the pivotal travel of the pivot bar 630. Likewise, a proximal end 636 of the pivot bar 630 has a proximal pin portion 638 that protrudes therefrom and is sized to be rotatably received in a hole 640 in the frame portion 48. An undercut area 642 may also be provided in the distal end 49 of the frame portion 48 to accommodate the pivotal travel of the pivot bar 630.

[0060] Also in this embodiment, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 may pivotally attached to frame portion 48 and slidingly attached to frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame 114. In various embodiments, a bellows-like sleeve 650 made from an elastomeric or polymeric material may be positioned over the shaft to at the location of the articulation joint to prevent debris and fluids from entering the joint. See FIG. 12.

[0061] FIGS. 14 and 15 illustrate another articulation joint 700 that may be employed in connection with various embodiments of the present invention. This embodiment may be substantially identical in construction to the above-described embodiments, except for the following differences. For example, in this embodiment, the distal end 49 of the frame portion 48 is formed as a protrusion 710 extending in a distal direction. In various embodiments, the distal protrusion 710 has a first lateral side 712 and a second lateral side 714. Similarly, the proximal end 115 of the distal frame member 114 is also formed as a protrusion 720 that extends in the proximal direction in confronting relationship relative to the distal protrusion 710. The proximal protrusion 720 has a primary lateral side 722 that corresponds to the first lateral side 712 of the distally extending protrusion 710. The proximally extending protrusion 720 further has a secondary lateral side 724 that corresponds to the second lateral side 714 of the distally extending protrusion 710.

[0062] In this embodiment, the flexible joint 700 may further include a first flexible band 730 that has a proximal end 732 attached to the first lateral side 712 of the distally extending protrusion 710 and a distal end 734 attached to the secondary lateral side 724 of the proximally extending protrusion 720. This embodiment may further include a second flexible band 740 that has a proximal end 742 attached to the second lateral side 714 of the distally extending protrusion 710 and a distal end 744 that is attached to the primary lateral side 722 of the proximally extending protrusion 720. In various embodiments the first flexible band 730 and second flexible band 740 may be fabricated from spring steel or other suitable flexible materials and be attached to the protrusions 710, 720, respectively, by suitable fastener arrangements such as screws, adhesive, etc. As can be seen in FIG. 14, the first flexible band has a first notch 736 therein and the second flexible band 740 has a second notch 746 therein to enable the bands 730, 740 to be arranged as shown in FIG. 15.

[0063] Also in this embodiment, to bridge the gap between frame portion 48 and the distal frame member 114, the fixed wall pivoting dog bone link 160 may pivotally attached to frame portion 48 and slidingly attached to frame member 114. Proximal pin 157 of the pivoting dog bone 160 is pivotally received in a bore 1824 in frame portion 48 enabling pivotal dog bone 160 to pivot therein. A distal pin 159 extends from pivotal dog bone 160 and is slidingly received in a slot 1826 in distal frame 114. In various embodiments, a bellows-like sleeve 750 made from an elastomeric or polymeric material may be positioned over the shaft to at the location of the articulation joint to prevent debris and fluids from entering the joint. See FIG. 14. The end effector may be articulated by applying an articulation force thereto by bringing the end effector into contact with a portion of the patient's body or with another instrument which may also be inserted into the patient's body.

[0064] While several embodiments of the invention have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the invention. For example, 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. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the disclosed invention as defined by the appended claims.

[0065] 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 may be reconditioned for reuse after at least one use. Reconditioning may 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 may be disassembled, and any number of 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 may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device may utilize a variety of different 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.

[0066] 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 higher 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.

[0067] 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.

[0068] The invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such equivalents, variations and changes which fall within the spirit and scope of the present invention as defined in the claims be embraced thereby.