US20060180634A1 - Surgical stapling instrument incorporating an e-beam firing mechanism - Google Patents

Abstract

A surgical severing and stapling instrument clamps, suitable for laparoscopic and endoscopic clinical procedures, clamps tissue within an end effector of an elongate channel pivotally opposed by an anvil. An E-beam firing bar moves distally through the clamped end effector to sever tissue and to drive staples on each side of the cut. The E-beam firing bar affirmatively spaces the spaces the anvil from the elongate channel to assure properly formed closed staples, especially when an amount of tissue is clamped that is inadequate to space the end effector. In particular, an upper pin of the firing bar longitudinally moves through an anvil slot and a channel clot is captured between a lower cap and a middle pin of the firing bar to assure a minimum spacing.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This is a continuation of prior application Ser. No. 10/443,617, entitled “SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHISM” to Frederick Shelton IV et al., filed 20 May 2003. AND
• Four co-pending and commonly-owned applications filed on even date herewith, the disclosure of each is hereby incorporated by reference in their entirety, these four applications being respectively entitled:
• (1) application Ser. No. 10/443,617 entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING” to Frederick E. Shelton IV et al., filed on 20 May 2003; application Ser. No. 10/441,424 entitled “SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING & FIRING SYSTEMS” to Frederick E. Shelton IV et al., filed on 20 May 2003. application Ser. No. 10/441,632, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT” to Frederick E. Shelton IV et al., filed on 20 May 2003 and application Ser. No. 10/441,565 entitled “SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL” to Frederick E. Shelton IV et al., filed on 20 May 2003.
FIELD OF THE INVENTION
• The present invention relates in general 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 stapler instruments and improvements in processes for forming various components of such stapler instruments.
BACKGROUND OF THE INVENTION
• Surgical staplers have been used in the prior art to simultaneously make a longitudinal incision in tissue and apply lines of staples on opposing sides of the incision. Such instruments commonly include a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges 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.
• The simultaneous severing of tissue while forming rows of staples on each side of the cut reduces bleeding and simplifies the surgical procedure. However, an appropriate amount of tissue should be clamped between the jaws so that proper staple formation is achieved and so that a cutting member does not bind or otherwise fail to fully cut the clamped tissue.
• A stapling and severing instrument that maintains a maximum jaw spacing is described in U.S. Pat. No. 4,429,695. In particular, a central knife carrier has an upper shoe that enters an upper passageway through an opening when the upper jaw is closed and has a lower shoe that is received within a lower passageway of the lower jaw. Thus, as the knife carrier is advanced distally, the shoes vertically and laterally position the upper and lower jaws. U.S. Pat. No. 4,429,695 teaches that the shoes are attached to the central knife carrier to resist vertical deflection (opening) of the jaws during ejection and forming of staples. As taught, the forces tend to vertically open the jaws during stapling. However, no mention is made of resisting forces that might be applied to vertically close the jaws. Additionally, this reference teaches that the device described therein is assembled from two separate, unconnected elements that are brought together and clamped onto tissue. The two elements form a device suitable only for an open procedure that has no size limitations.
• Increasingly, endoscopic and laparoscopic procedures are preferred over open procedures due to their reduced post-operative recovery times and other advantages. Endoscopic stapling and severing instruments use a long slender jaw member that tends to deflect upwardly when clamped onto thick tissues. On thick tissue, this upward deflection of the free (distal) end of the jaw can cause differences in height of the formed staples as the distal gap between the anvil and cartridge is larger than the proximal gap. To ensure more uniform proximal to distal staple formation, the anvil is frequently cambered or bent inwardly toward the staple cartridge. This camber is better for thick tissue and can cause tighter staple forms at the distal end when used on thin tissue. To overcome this tight distal closure, pins or bumps have been added to the clamping surface of the cartridge adjacent to the distal end of the cartridge. The closure of the anvil onto the pin ensures a minimum gap at the distal end. However, surgeons were concerned about the pins or bumps causing tissue trauma. What is needed is a mechanism for maintaining a minimal gap between the anvil and cartridge and a mechanism for maintaining a maximum gap between the anvil and cartridge.
• An example of a surgical stapler suitable for endoscopic applications is described in U.S. Pat. No. 5,465,895, which advantageously provides distinct closing and firing actions. Thereby, a clinician is able to close the jaw members upon tissue to position the tissue prior to firing. Once the clinician has determined that the jaw members are properly gripping tissue, the clinician can then fire the surgical stapler, thereby severing and stapling the tissue. The simultaneous severing and stapling avoids complications that may arise when performing such actions sequentially with different surgical tools that respectively only sever or staple.
• One specific advantage of being able to close upon tissue before firing is that the clinician is able to verify via an endoscope that a sufficient amount of tissue has been captured between opposing jaws. Otherwise, opposing jaws may be drawn too close together, especially pinching at their distal ends, and thus not effectively forming closed staples in the severed tissue. Moreover, a firing bar that traverses between opposing jaws to sever the tissue and to drive the wedges that drive the staples may encounter resistance due to the pinched opposing jaws.
• Thus, while such surgical staplers have been a significant advance in surgical procedures, an opportunity has been recognized for enhancing their effectiveness. In particular, it would be desirable to affirmatively maintain proper spacing between the opposing jaws during firing, both opening and closing deflections. In particular, endoscopic devices need to fit into an access device such a trocar, and must maintain a small shaft diameter. To date, no endoscopic stapling device has been provided that has room for a pair for longitudinal passageways for shoes on a cutter that resists both tensile and compressive jaw loadings.
• Furthermore, it is desirable to maintain other advantages of U.S. Pat. No. 5,465,895 to include a wedge sled integral to a staple cartridge, rather than having camming surfaces attached to a cutter. Thereby, fabrication of the cutter is simplified, as is installation of the staple cartridge. Significantly, an integral wedge sled may be designed specifically for each size and application of a staple cartridge, allowing the stapling and severing instrument increased number of uses. In particular, the thickness of the staple cartridge may be based on the desired tissue thickness. Also, the number and spacing of rows of staples may vary.
• Consequently, a significant need exists for an improved surgical stapling and severing instrument that maintains proper spacing in its end effector to achieve proper stapling of the severed tissue, yet retains the advantages of a staple cartridge having an integral wedge sled.
BRIEF SUMMARY OF THE INVENTION
• The invention overcomes the above-noted and other deficiencies of the prior art by providing a firing mechanism that affirmatively vertically spaces an end effector of a surgical stapling and severing instrument. Thus, the instrument structurally assures adequate spacing to achieve proper stapling, even in instances where too little tissue is clamped in the end effector.
• In one aspect of the invention, a surgical instrument includes a handle portion operable to produce a firing motion that actuates an implement portion. This implement portion has an elongate channel that receives a staple cartridge opposed by a pivotally attached anvil. A firing device includes a distally presented cutting edge longitudinally received between the elongate channel and the anvil, an upper member engageable to the anvil channel, a lower member engaging the channel slot, and a middle member operable to actuate the wedge sled, which is integral to the staple cartridge. The middle member advantageously opposes pinching of the end effector, assuring proper staple formation even when an otherwise too small amount of tissue has been clamped.
• In another aspect of the invention, a surgical instrument is provided that is suitable for endo-surgical and laparoscopic procedures by have a diametrically sized end effector and shaft of the implement portion. A handle portion produces both a closing motion and firing motion that are transferred distally through the shaft of the implement portion. The firing mechanism responds to the firing motion by engaging both the anvil and the elongate channel to effect severing of clamped tissue and to affirmatively space the anvil and elongate channel to assure proper staple formation.
• These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
BRIEF DESCRIPTION OF THE FIGURES
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
• FIG. 1 depicts a partially cut-away side elevation view of a surgical stapling and severing instrument in an open position.
• FIG. 2 depicts a cross-sectional side elevation detail view along the line2-2 ofFIG. 1 of an end effector of the surgical stapling and severing instrument.
• FIG. 3 depicts an enlarged side elevation view of the firing bar of the surgical stapling and severing instrument ofFIG. 2.
• FIG. 4 depicts an enlarged front view of the firing bar of the surgical stapling and severing instrument ofFIG. 2.
• FIG. 5 depicts a cross-sectional side elevation detail view of an alternative end effector for the surgical stapling and severing instrument ofFIG. 1, incorporating a firing bar that lacks a middle pin for preventing pinching of the end effector.
• FIG. 6 depicts a side elevational view of a handle portion of a proximal end of the surgical stapling and severing instrument ofFIG. 1 with a left side removed to expose interior parts in an unclamped, unfired (“start”) position.
• FIG. 7 depicts a perspective, exploded view of the handle portion of the proximal end of the surgical stapling and severing instrument ofFIG. 1.
• FIG. 8 depicts a side elevational view of the handle portion of the proximal end of the surgical stapling and severing instrument ofFIG. 1 with the left side removed to expose interior parts in the closed (“clamped”) position.
• FIG. 9 depicts a side elevational view of the handle portion of proximal end of surgical stapling and severing instrument ofFIG. 1 with the left side removed to expose interior parts in the stapled and severed (“fired”) position.
• FIG. 10 depicts an isometric view of the end effector at the distal end of the surgical stapling and severing instrument ofFIG. 1 with the anvil in the up or open position exposing the staple cartridge and cutting edge of the firing bar.
• FIG. 10 depicts an isometric, exploded view of the implement portion of the surgical stapling and severing instrument ofFIG. 1.
• FIG. 12 depicts an isometric view of the end effector at the distal end of the surgical stapling and severing instrument ofFIG. 1 with the anvil in the up or open position with the cartridge largely removed exposing a single staple driver and a double staple driver as exemplary and the wedge sled in its start position against a middle pin of the firing bar.
• FIG. 13 depicts an isometric view of the distal end of the surgical stapling and severing instrument ofFIG. 1 with the anvil in the up or open position with the staple cartridge completely removed and a portion of an elongate channel removed to expose a lowermost pin of the firing bar.
• FIG. 14 depicts a side elevation view in section showing a mechanical relationship between the anvil, elongate channel, and staple cartridge in the closed position of the surgical stapling and severing instrument ofFIG. 1, the section generally taken along lines14-14 ofFIG. 10 to expose wedge sled, staple drivers and staples but also depicting the firing bar along the longitudinal centerline.
• FIG. 15 depicts a section view of the end effector of the surgical stapling and severing instrument with the cartridge and firing bar in the start position taken along line15-15 ofFIG. 10.
• FIG. 16 depicts a section view taken along line16-16 ofFIG. 15 showing the cross-sectional relationship between the firing bar, elongate channel, wedge sled, staple drivers, staples and staple cartridge.
• FIG. 17 depicts a side elevation section view of the surgical stapling and severing instrument ofFIG. 1 taken along the longitudinal centerline of the end effector in a partially closed but unclamped position gripping tissue.
• FIG. 18 depicts a partially cut-away side elevational view of the surgical stapling and severing instrument ofFIG. 1 in the closed or clamped position.
• FIG. 19 depicts a side elevation view in centerline section of the distal end of the surgical stapling and severing instrument ofFIG. 1 in the closed or clamped position with tissue properly compressed.
• FIG. 20 depicts a partially cut-away side elevation view of the surgical stapling and severing instrument ofFIG. 1 in a partially fired position.
• FIG. 21 depicts a view in centerline section of the distal end of the surgical stapling and severing instrument ofFIG. 1 in a partially fired position.
• FIG. 22 depicts a partially cut-away side elevation view of the surgical stapling and severing instrument ofFIG. 1 in a fully fired position.
• FIG. 23 depicts a view in centerline section of the distal end of the surgical stapling and severing instrument ofFIG. 1 in a fully fired position.
DETAILED DESCRIPTION OF THE INVENTION
• Turning to the Drawings, wherein like numerals denote like components throughout the several views,FIG. 1 and2 depict a surgical stapling and severinginstrument10 that is capable of practicing the unique benefits of the present invention. The surgical stapling and severinginstrument10 incorporates anend effector12 having an E-beam firing mechanism (“firing bar”)14 that advantageously controls the spacing of theend effector12. In particular, anelongate channel16 and a pivotallytranslatable anvil18 are maintained at a spacing that assures effective stapling and severing. The problems are avoided associated with varying amounts of tissue being captured in theend effector12.
• The surgical and stapling and severinginstrument10 includes ahandle portion20 connected to an implementportion22, the latter further comprising ashaft23 distally terminating in theend effector12. Thehandle portion20 includes apistol grip24 toward which aclosure trigger26 is pivotally drawn by the clinician to cause clamping, or closing, of theanvil18 toward theelongate channel16 of theend effector12. A firingtrigger28 is farther outboard of theclosure trigger26 and is pivotally drawn by the clinician to cause the stapling and severing of clamped tissue in theend effector12.
• It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping a handle of an instrument. Thus, theend effector12 is distal with respect to the moreproximal handle portion20. It will be further appreciated that for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
• Closure trigger26 is actuated first. Once the clinician is satisfied with the positioning of theend effector12, the clinician may draw back theclosure trigger26 to its fully closed, locked position proximate to thepistol grip24. Then, the firingtrigger28 is actuated. The firingtrigger28 springedly returns when the clinician removes pressure. Arelease button30 when depressed on the proximal end of thehandle portion20 releases any lockedclosure trigger26.
• Aclosure sleeve32 encloses aframe34, which in turn encloses afiring drive member36 that is positioned by the firingtrigger28. Theframe34 connects thehandle portion20 to theend effector12. With theclosure sleeve32 withdrawn proximally by theclosure trigger26 as depicted, theanvil18 springedly opens, pivoting away from theelongate channel16 and translating proximally with theclosure sleeve32.
• Theelongate channel16 receives astaple cartridge37 that is responsive to the firingbar14 to drive staples into forming contact with theanvil18. It will appreciated that although a readilyreplaceable staple cartridge37 is advantageously described herein, astaple cartridge37 consistent with aspects of the present invention may be permanently affixed or integral to theelongate channel16, for instance when a larger portion of theend effector12 is replaced after each firing.
• E-Beam Firing Mechanism
• With particular reference toFIGS. 2-4, the firingbar14 includes three vertically spaced pins that control the spacing of theend effector12 during firing. In particular, anupper pin38 is staged to enter ananvil pocket40 near the pivot between theanvil18 andelongate channel16. When fired with theanvil18 closed, theupper pin38 advances distally within alongitudinal anvil slot42 extending distally throughanvil18. Any minor upward deflection in theanvil18 is overcome by a downward force imparted by theupper pin38.
• Firingbar14 also includes a lower most pin, or firing bar cap,44 that upwardly engages achannel slot45 in theelongate channel16, thereby cooperating with theupper pin38 to draw theanvil18 and theelongate channel16 slightly closer together in the event of excess tissue clamped therebetween.
• The firingbar14 advantageously includes amiddle pin46 that passes through afiring drive slot47 formed in a lower surface of thecartridge37 and an upward surface of theelongate channel16, thereby driving the staples therein as described below. Themiddle pin46, by sliding against theelongate channel16, advantageously resists any tendency for theend effector12 to be pinched shut at its distal end. To illustrate an advantage of themiddle pin46,FIG. 5 depicts analternative end effector12′ that lacks a middle pin on a firingbar14′. In this depiction, theend effector12′ is allowed to pinch shut at its distal end, which tends to impair desired staple formation.
• Returning toFIGS. 2-4, a distally presented cuttingedge48 between the upper andmiddle pins38,46 on the firingbar14 traverses through a proximally presented,vertical slot49 in thecartridge37 to sever clamped tissue. The affirmative positioning of the firingbar14 with regard to theelongate channel16 andanvil18 assure that an effective cut is performed.
• Cambered Anvil with Selected Cartridge Gap
• The affirmative vertical spacing provided by theE-Beam firing bar14 is suitable for the limited size available for endoscopic devices. Moreover, theE-Beam firing bar14 enables fabrication of ananvil16 with a camber imparting a vertical deflection at its distal end, similar to the position depicted inFIG. 5. Thiscambered anvil16 advantageously assists in achieving the desired gap in theend effector12 even with ananvil16 reduced thickness, which is thus more suited to the size limitations of an endoscopic device.
• TheE-Beam firing bar14 further enables increased applications, especially in combination with a range of configurations of staple cartridges. For instance, a clinician may select a gray staple cartridge yielding a 0.02 mm tissue gap, a white staple cartridge yielding a 0.04 mm tissue gap, a blue cartridge yielding a 0.06 mm tissue gap, or a green cartridge yielding a 0.10 mm tissue gap. The vertical height of each respective staple cartridge in combination with the length of staples and an integral wedge sled (described in more detail below) predetermines this desired tissue thickness with theanvil18 appropriately vertically spaced by theE-Beam firing bar14.
• Two-Axis Handle
• With reference toFIGS. 6-9, thehandle portion20 is comprised of first andsecond base sections50 and52, which are molded from a polymeric material such as a glass-filled polycarbonate. Thefirst base section50 is provided with a plurality of cylindrical-shaped pins54. Thesecond base section52 includes a plurality of extendingmembers56, each having a hexagonal-shapedopening58. The cylindrical-shapedpins54 are received within the hexagonal-shapedopenings58 and are frictionally held therein for maintaining the first andsecond base sections50 and52 in assembly.
• A rotatingknob60 has abore62 extending completely through it for engaging and rotating the implementportion22 about its longitudinal axis. The rotatingknob60 includes an inwardly protrudingboss64 extending along at least a portion of thebore62. The protrudingboss64 is received within a longitudinal slot66-formed at a proximal portion of theclosure sleeve32 such that rotation of therotating knob60 effects rotation of theclosure sleeve32. It will be appreciated that theboss64 further extends throughframe34 and into contact with a portion of the firingdrive member36 to effect their rotation as well. Thus, the end effector12 (not shown inFIGS. 6-9) rotates with the rotatingknob60.
• Aproximal end68 of theframe34 passes proximally through the rotatingknob60 and is provided with acircumferential notch70 that is engaged by opposing channel securement members72 extending respectively from thebase sections50 and52. Only the channel securement member72 of thesecond base section52 is shown. The channel securement members72 extending from thebase sections50,52 serve to secure theframe34 to thehandle portion20 such that theframe34 does not move longitudinally relative to thehandle portion20.
• Theclosure trigger26 has ahandle section74, agear segment section76, and anintermediate section78. A bore80 extends through theintermediate section78. Acylindrical support member82 extending from thesecond base section52 passes through thebore80 for pivotably mounting theclosure trigger26 on thehandle portion20. A second cylindrical support member83 extending from thesecond base section52 passes through abore81 of firingtrigger28 for pivotally mounting on thehandle portion20. Ahexagonal opening84 is provided in the cylindrical support member83 for receiving a securement pin (not shown) extending from thefirst base section50.
• Aclosure yoke86 is housed within thehandle portion20 for reciprocating movement therein and serves to transfer motion from theclosure trigger26 to theclosure sleeve32.Support members88 extending from thesecond base section52 and securement member72, which extends through arecess89 in theyoke86, support theyoke86 within thehandle portion20.
• Aproximal end90 of theclosure sleeve32 is provided with aflange92 that is snap-fitted into a receivingrecess94 formed in adistal end96 of theyoke86. Aproximal end98 of theyoke86 has agear rack100 that is engaged by thegear segment section76 of theclosure trigger26. When theclosure trigger26 is moved toward thepistol grip24 of thehandle portion20, theyoke86 and, hence, theclosure sleeve32 move distally, compressing aspring102 that biases theyoke86 proximally. Distal movement of theclosure sleeve32 effects pivotal translation movement of theanvil18 distally and toward theelongate channel16 of theend effector12 and proximal movement effects closing, as discussed below.
• Theclosure trigger26 is forward biased to an open position by afront surface130 interacting with anengaging surface128 of the firingtrigger28. Clampfirst hook104 that pivots top to rear in thehandle portion20 about apin106 restrains movement of the firingtrigger28 toward thepistol grip24 until theclosure trigger26 is clamped to its closed position.Hook104 restrains firingtrigger28 motion by engaging alockout pin107 in firingtrigger28. Thehook104 is also in contact with theclosure trigger26. In particular, aforward projection108 of thehook104 engages amember110 on theintermediate section78 of theclosure trigger26, themember110 being outward of thebore80 toward thehandle section74.Hook104 is biased toward contact withmember110 of theclosure trigger26 and engagement withlockout pin107 in firingtrigger28 by arelease spring112. As theclosure trigger26 is depressed, thehook104 is moved top to rear, compressing therelease spring112 that is captured between arearward projection114 on thehook104 and aforward projection116 on therelease button30.
• As theyoke86 moves distally in response to proximal movement of theclosure trigger26, anupper latch arm118 of therelease button30 moves along anupper surface120 on theyoke86 until dropping into an upwardly presentedrecess122 in a proximal, lower portion of theyoke86. Therelease spring112 urges therelease button30 outward, which pivots theupper latch arm118 downwardly into engagement with the upwardly presentedrecess122, thereby locking theclosure trigger26 in a tissue clamping position, such as depicted inFIG. 8.
• Thelatch arm118 can be moved out of therecess122 to release theanvil18 by pushing therelease button30 inward. Specifically, theupper latch arm118 pivots upward aboutpin123 of thesecond base section52. Theyoke86 is then permitted to move proximally in response to return movement of theclosure trigger26.
• A firingtrigger return spring124 is located within thehandle portion20 with one end attached to pin106 of thesecond base section52 and the other end attached to apin126 on the firingtrigger28. The firingreturn spring124 applies a return force to thepin126 for biasing the firingtrigger28 in a direction away from thepistol grip24 of thehandle portion20. Theclosure trigger26 is also biased away frompistol grip24 by engagingsurface128 of firingtrigger28 biasingfront surface130 ofclosure trigger26.
• As theclosure trigger26 is moved toward thepistol grip24, itsfront surface130 engages with theengaging surface128 on the firingtrigger28 causing the firingtrigger28 to move to its “firing” position. When in its firing position, the firingtrigger28 is located at an angle of approximately 45° to thepistol grip24. After staple firing, thespring124 causes the firingtrigger28 to return to its initial position. During the return movement of the firingtrigger28, its engagingsurface128 pushes against thefront surface130 of theclosure trigger26 causing theclosure trigger26 to return to its initial position. Astop member132 extends from thesecond base section52 to prevent theclosure trigger26 from rotating beyond its initial position.
• The surgical stapling and severinginstrument10 additionally includes areciprocating section134, amultiplier136 and adrive member138. Thereciprocating section134 comprises a wedge sled in the implement portion22 (not shown inFIG. 6-9) and ametal drive rod140.
• Thedrive member138 includes first and second gear racks141 and142. Afirst notch144 is provided on thedrive member138 intermediate the first and second gear racks141,142. During return movement of the firingtrigger28, atooth146 on the firingtrigger28 engages with thefirst notch144 for returning thedrive member138 to its initial position after staple firing. Asecond notch148 is located at a proximal end of themetal drive rod140 for locking themetal drive rod140 to theupper latch arm118 of therelease button30 in its unfired position.
• Themultiplier136 comprises first and second integral pinion gears150 and152. The firstintegral pinion gear150 is engaged with afirst gear rack154 provided on themetal drive rod140. The secondintegral pinion gear152 is engaged with thefirst gear rack141 on thedrive member138. The firstintegral pinion gear150 has a first diameter and the secondintegral pinion gear152 has a second diameter which is smaller than the first diameter.
• FIGS. 6, 8 and9 depict respectively thehandle portion20 in the start position (open and unfired), a clamped position (closed and unfired) and a fired position. The firingtrigger28 is provided with agear segment section156. Thegear segment section156 engages with thesecond gear rack142 on thedrive member138 such that motion of the firingtrigger28 causes thedrive member138 to move back and forth between a first drive position, shown inFIG. 8, and a second drive position, shown inFIG. 9. In order to prevent staple firing before tissue clamping has occurred, theupper latch arm118 on therelease button30 is engaged with thesecond notch148 on thedrive member138 such that themetal drive rod140 is locked in its proximal-most position, as depicted inFIG. 6. When theupper latch arm118 falls into therecess122, theupper latch arm118 disengages with thesecond notch148 to permit distal movement of themetal drive rod140, as depicted inFIG. 9.
• Because thefirst gear rack141 on thedrive member138 and thegear rack154 on themetal drive rod140 are engaged with themultiplier136, movement of the firingtrigger28 causes themetal drive rod140 to reciprocate between a first reciprocating position, shown inFIG. 8, and a second reciprocating position, shown inFIG. 9. Since the diameter of thefirst pinion gear150 is greater than the diameter of thesecond pinion gear152, themultiplier136 moves the reciprocating section134 a greater distance than thedrive member138 is moved by the firingtrigger28. The diameters of the first and second pinion gears150 and152 may be changed to permit the length of the stroke of the firingtrigger28 and the force required to move it to be varied.
• It will be appreciated that thehandle portion20 is illustrative and that other actuation mechanisms may be employed. For instance, the closing and firing motions may be generated by automated means.
• Separate and Distinct Closing and Firing End Effector
• Theend effector12 of the surgical stapling and severinginstrument10 is depicted in further detail inFIGS. 10-16. As described above, thehandle portion20 produces separate and distinct closing and firing motions that actuate theend effector12. Theend effector12 advantageously maintains the clinical flexibility of this separate and distinct closing and firing (i.e., stapling and severing). In addition, theend effector12 introduces the aforementioned ability to affirmatively maintain the closed spacing during firing after the clinician positions and clamps the tissue. Both features procedurally and structurally enhance the ability of the surgical stapling and severinginstrument10 by ensuring adequate spacing for instances where an otherwise inadequate amount of tissue is clamped and to enhance the clamping in instances where an otherwise excessive amount of tissue has been clamped.
• FIG. 10 depicts theend effector12, which is in an open position by a retractedclosure sleeve32, with astaple cartridge37 installed in theelongate channel16. On alower surface200 of theanvil18, a plurality ofstapling forming pockets202 are arrayed to correspond to a plurality ofstapler apertures204 in anupper surface206 of thestaple cartridge37. The firingbar14 is at its proximal position, with theupper pin38 aligned in a noninterfering fashion with theanvil pocket40. Theanvil pocket40 is shown as communicating with thelongitudinal anvil slot42 in theanvil18. The distally presented cuttingedge48 of the firing.bar14 is aligned with and proximally from removed from thevertical slot49 in thestaple cartridge37, thereby allowing removal of a spent cartridge and insertion of an unfired cartridge, which is snapfit into theelongate channel16. Specifically, extension features208,210 of thestaple cartridge37 engagerecesses212,214 (shown inFIG. 12) of theelongate channel16.
• FIG. 11 shows the implementportion22 of the surgical stapling and severinginstrument10 in disassembled form. Thestaple cartridge37 is shown as being comprised of acartridge body216, awedge sled218, single anddouble drivers220,staples222, and acartridge tray224. When assembled, thecartridge tray224 holds thewedge sled218, single anddouble drivers220, andstaples222 inside thecartridge body216.
• Having awedge sled218 integral to thestaple cartridge37 enables a number of flexible design options as compared to incorporating camming surfaces onto a firing bar itself. For instance, a number of different staple cartridges may be selected for use in theinstrument10 with each staple cartridge having a different configuration of rows of staples, each thus having a unique wedge sled configured to contact themiddle pin46 of the firingbar14 while causing the driving of thestaples222. As another example, theintegral wedge sled218 provides an opportunity for a number of lockout features, described in greater detail in the first and third aforementioned co-pending applications.
• Theelongate channel16 has a proximally placedattachment cavity226 that receives achannel anchoring member228 on the distal end of theframe34 for attaching theend effector12 to thehandle portion20. Theelongate channel16 also has ananvil cam slot230 that pivotally receives ananvil pivot232 of theanvil18. Theclosure sleeve32 that encompasses theframe34 includes a distally presentedtab234 that engages ananvil feature236 proximate but distal to theanvil pivot232 on theanvil18 to thereby effect opening and closing of theanvil18. The firingdrive member36 is shown as being assembled from the firingbar14 attached to afiring connector238 bypins240, which in turn is rotatingly and proximally attached to themetal drive rod140. The firingbar14 is guided at a distal end of the frame by a slottedguide239 inserted therein.
• With particular reference toFIG. 12, a portion of thestaple cartridge37 is removed to expose portions of theelongate channel16, such asrecesses212,214 and to expose some components of thestaple cartridge37 in their unfired position.
• In particular, the cartridge body216 (shown inFIG. 11) has been removed. Thewedge sled218 is shown at its proximal, unfired position with apusher block242 contacting the middle pin46 (not shown inFIG. 12) of the firingbar14. Thewedge sled218 is in longitudinal sliding contact upon thecartridge tray224 and includeswedges228 that force upward the single anddouble drivers220 as thewedge sled218 moves distally. Staples222 (not shown inFIG. 12) resting upon thedrivers220 are thus also forced upward into contact with theanvil forming pockets202 on theanvil18 to form closed staples. Also depicted is thechannel slot45 in theelongate channel16 that is aligned with thevertical slot49 in thestaple cartridge37.
• FIG. 13 depicts theend effector12 ofFIG. 12 with all of thestaple cartridge37 removed to show themiddle pin46 of the firingbar14 as well as portion of theelongate channel16 removed adjacent to thechannel slot45 to expose the firingbar cap44. In addition, portions of theshaft23 are removed to expose a proximal portion of the firingbar14. Projecting downward from theanvil18 near the pivot, a pair of opposing tissue stops244 prevent tissue being positioned too far up into theend effector12 during clamping.
• FIG. 14 depicts theend effector12 closed in a tissue clamping position with the firingbar14 unfired. Theupper pin38 is in theanvil pocket40, vertically aligned with theanvil slot42 for distal longitudinal movement of the firingbar14 during firing. Themiddle pin46 is positioned to push thewedge sled218 distally so thatwedge228 sequentially contacts and liftsdouble drivers220 and therespective staples222 into forming contact withstaple forming pockets202 in thelower surface200 of theanvil18.
• FIG. 15 depicts theupper surface206 of thestaple cartridge37 with the firingbar14 in its unfired, proximal position. Thestapler apertures204 are arrayed on each side of thevertical slot49 in thestaple cartridge37.
• FIG. 16 depicts theend effector12 near the pivot showing that theelongate channel16 has opposingramp portions246 to thereby cooperate with the tissue stops244 of the anvil18 (not shown inFIG. 16) to prevent tissue from jamming theend effector12. Also depicted in greater detail are thedouble drivers220 and their relation to thestaples222.
• Operation
• In use, the surgical stapling and severinginstrument10 is used as depicted inFIGS. 1, 2, and17-23. InFIGS. 1-2, theinstrument10 is in its start position, having had an unfired, fully loadedstaple cartridge37 snap-fitted into the distal end of theelongate channel16. Both triggers26,28 are forward and theend effector12 is open, such as would be typical after inserting theend effector12 through a trocar or other opening into a body cavity. Theinstrument10 is then manipulated by the clinician such thattissue248 to be stapled and severed is positioned between thestaple cartridge37 and theanvil18, as depicted inFIG. 17.
• With reference toFIGS. 18-19, next, the clinician moves theclosure trigger26 proximally until positioned directly adjacent to thepistol grip24, locking thehandle portion20 into the closed and clamped position. The retractedfiring bar14 in theend effector12 does not impede the selective opening and closing of theend effector12, but rather resides within theanvil pocket40. With theanvil18 closed and clamped, theE-beam firing bar14 is aligned for firing through theend effector12. In particular, theupper pin38 is aligned with theanvil slot42 and theelongate channel16 is affirmatively engaged about thechannel slot45 by themiddle pin46 and the firingbar cap44.
• With reference toFIGS. 20-21, after tissue clamping has occurred, the clinician moves the firingtrigger28 proximally causing the firingbar14 to move distally into theend effector12. In particular, themiddle pin46 enters thestaple cartridge37 through the firingdrive slot47 to effect the firing of the staples222 (not shown inFIGS. 20-21) viawedge sled218 toward theanvil18. The lower most pin, or firingbar cap44, cooperates with themiddle pin46 to slidinglyposition cutting edge48 of the firingbar14 to sever tissue. The twopins44,46 also position theupper pin38 of the firingbar14 withinlongitudinal anvil slot42 of theanvil18, affirmatively maintaining the spacing between theanvil18 and theelongate channel16 throughout its distal firing movement.
• With reference toFIGS. 22-23, the clinician continues moving the firingtrigger28 until brought proximal to theclosure trigger26 andpistol grip24. Thereby, all of the ends of thestaples222 are bent over as a result of their engagement with theanvil18. The firingbar cap44 is arrested against a firingbar stop250 projecting toward the distal end of thechannel slot45. Thecutting edge48 has traversed completely through the tissue. The process is complete by releasing the firingtrigger28 and by then depressing therelease button30 while simultaneously squeezing theclosure trigger26 to open theend effector12.
• While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.
• For example, the affirmative spacing of theanvil18 andelongate channel16 is achieved in part with twopins44,46 on the firingbar14 engaging opposite sides of achannel slot47 and a singleupper pin38 entrained within ananvil slot42. It would consistent with aspects of the invention for the anvil to be captured by opposing pins on either side of a longitudinal slot and/or for an elongate channel to have an internal slot that entrains a lower pin.
• For another example, although theE-beam firing beam14 has advantages for an endoscopically employed surgical severing and staplinginstrument10, a similar E-Beam may be used in other clinical procedures. It is generally accepted that endoscopic procedures are more common than laparoscopic procedures. Accordingly, the present invention has been discussed in terms of endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic”, should not be construed to limit the present invention to a surgical stapling and severing instrument for use only in conjunction with an endoscopic tube (i.e., trocar). On the contrary, it is believed that the present invention may find use in any procedure where access is limited to a small incision, including but not limited to laparoscopic procedures, as well as open procedures.
• For yet another example, although anillustrative handle portion20 described herein is manually operated by a clinician, it is consistent with aspects of the invention for some or all of the functions of a handle portion to be powered (e.g., pneumatic, hydraulic, electromechanical, ultrasonic, etc.). Furthermore, controls of each of these functions may be manually presented on a handle portion or be remotely controlled (e.g., wireless remote, automated remote console, etc.).
• As yet an additional example, although a simultaneous stapling and severing instrument is advantageously illustrated herein, it would be consistent with aspects of the invention for stapling to comprise other types of fasteners and attachment techniques.

Claims (11)

1. A surgical instrument comprising:

a handle portion operable to produce a firing motion;

an implement portion responsive to the firing motions from the handle portion, the implement portion comprising:

an elongate channel coupled to the handle portion and including a channel slot,

a staple cartridge received by the elongate channel and incorporating a proximally positioned wedge member aligned to cam upward a driver supporting a staple,

an anvil pivotally coupled to the elongate channel and including an anvil channel,

a firing device including a distally presented cutting edge longitudinally received between the elongate channel and the anvil, an upper member engageable to the anvil channel, a lower member engaging the channel slot, and a middle member operable to actuate the staple cartridge by distally translating the wedge member of the staple cartridge.

2. The surgical instrument ofclaim 1, wherein the anvil forms an inwardly biased relation to the elongate channel configured to assist the firing device in affirmatively spacing between the anvil and elongate channel during actuation of the staple cartridge.

3. The surgical instrument ofclaim 1, wherein the staple cartridge is a selected type of a plurality of staple cartridge types, each staple cartridge type characterized by a thickness selected for a desired spacing between the anvil and elongate channel and characterized by staples having a length suitable for the desired spacing.

4. The surgical instrument ofclaim 3, wherein the wedge sled comprises a plurality of connected camming wedges each having a preselected height configured for the selected type of staple cartridge, the middle member of the firing device oriented to abut each of the plurality of staple cartridge types.

5. A surgical instrument comprising:

a handle portion operable to produce a firing motion and a closing motion;

an implement portion responsive to the firing motions from the handle portion and diametrically dimensioned for endo-surgical use, the implement portion comprising:

a shaft coupled to the handle portion operable to separately transfer the firing motion and the closing motion;

an elongate channel coupled to the shaft and including a channel slot,

an anvil pivotally coupled to the elongate channel, responsive to the closing motion from the shaft, and including an anvil channel,

a firing device including a distally presented cutting edge longitudinally received between the elongate channel and the anvil, the firing device configured to affirmatively space the anvil from the elongate channel during longitudinal travel between the anvil and elongate channel.

6. The surgical instrument ofclaim 5, further comprising a staple cartridge engaged by the elongate channel and including a proximally opened slot for receiving the cutting edge of the firing device, the staple cartridge including a plurality of staples cammed upwardly by the distal longitudinal movement of the firing mechanism.

7. The surgical instrument ofclaim 6, wherein the staple cartridge further includes a plurality of drivers supporting the plurality of staples and a wedge sled responsive to the distal longitudinal movement of the firing mechanism to cam upwardly the drivers and thus form the plurality of staples against the anvil.

8. The surgical instrument ofclaim 6, wherein the anvil forms an inwardly biased relation to the elongate channel configured to assist the firing device in affirmatively spacing between the anvil and elongate channel during actuation of the staple cartridge.

9. The surgical instrument ofclaim 6, wherein the staple cartridge is a selected type of a plurality of staple cartridge types, each staple cartridge type characterized by a thickness selected for a desired spacing between the anvil and elongate channel and characterized by staples having a length suitable for the desired spacing.

10. The surgical instrument ofclaim 9, wherein the wedge sled comprises a plurality of connected camming wedges each having a preselected height configured for the selected type of staple cartridge, the middle member of the firing device oriented to abut each of the plurality of staple cartridge types.

11. A surgical instrument, comprising:

a handle means for producing a closing motion and a firing motion;

a clamping means responsive to the closing motion to clamp tissue;

a firing means responsive to the firing motion for vertically spacing the clamping means and for causing severing and stapling of clamped tissue therein.

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