Test device for a surgical tool

In various embodiments, a surgical test device for a surgical tool, such as a severing and/or sealing tool (e.g., a surgical stapler), is provided. In at least one embodiment, the surgical tool can be configured to supply at least one actuation motion to an end effector. The actuation motion(s) may cause a cutting member to move within and/or sealing members (e.g., staples) to eject from the end effector. Further, in at least one embodiment, the surgical test device can be releasably engaged to a portion of the surgical tool, such as the end effector. Additionally, the surgical test device can be configured to permit the surgical tool to supply the actuation motion(s) while preventing the tool from performing its intended surgical function. Accordingly, the surgical tool may be test fired without wasting a sealing member cartridge, while preventing inappropriate use of the tool when the test device is attached thereto.

BACKGROUND

The embodiments relate, in general, to surgical sealing and severing tools, such as a surgical stapler or endocutter, and, more particularly, to a test device for such a surgical tool.

An endocutter is a surgical stapler instrument that is capable of applying lines of staples to tissue while cutting the tissue between those staple lines. Surgical staplers have been used in the field 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.

An example of a surgical stapler suitable for endoscopic applications is described in U.S. Pat. Application Pub. No. 2004/0232196 A1, the disclosure of which is incorporated herein by reference in its entirety, 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.

It is often advantageous to build an end effector for the surgical stapler that is reusable. For instance, one patient may need a series of severing and stapling operations during a surgical procedure. Replacing an entire end effector for each operation during the procedure tends to be economically inefficient. This is especially true if the end effector is built to be strong and reliable over repeated operations. To that end, staple cartridges are fitted into the end effector prior to each operation of the surgical stapler. Thus, a much smaller amount of the surgical stapler is discarded after each use.

Further, while the staple cartridge provides numerous advantages, it is desirable to prevent inadvertent firing of the surgical stapler when an unfired staple cartridge is not present. Otherwise, the severing of tissue may occur without the staples present to minimize bleeding and/or leaking. Accordingly, some surgical staplers are equipped with a lockout mechanism to prevent firing unless an unfired staple cartridge is present. Exemplary surgical staplers including a lockout mechanism may include those described in the following documents, the disclosures of which are hereby incorporated by reference in their respective entireties: U.S. patent application Ser. No. 10/441,424, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Shelton, IV et al. (which issued as U.S. Pat. No. 7,044,352); U.S. patent application Ser. No. 10/441,565, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT,” to Shelton, IV et al. (which issued as U.S. Pat. No. 6,988,649); U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (which issued as U.S. Pat. No. 7,380,695); U.S. patent application Ser. No. 11/066,371, entitled “SURGICAL STAPLING INSTRUMENT HAVING AN ELECTROACTIVE POLYMER ACTUATED SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Shelton, IV et al. (which issued as U.S. Pat. No. 7,140,528); U.S. patent application Ser. No. 11/266,961, entitled “LOCKOUT MECHANISMS AND SURGICAL INSTRUMENTS INCLUDING SAME,” to Ortiz et al. (which published as U.S. Pat. App. Pub. No. 2007/0102475); and U.S. patent application Ser. No. 11/651,788, entitled “INTERLOCK AND SURGICAL INSTRUMENT INCLUDING SAME,” to Shelton, IV et al. (which published as U.S. Pat. App. Pub. No. 2008/0167670).

The foregoing discussion is intended only to illustrate the present field and should not be taken as a disavowal of claim scope.

SUMMARY

In various embodiments, a surgical instrument is provided. In at least one embodiment, the surgical instrument can comprise a surgical tool and a surgical test device releasably engaged to at least a portion of the surgical tool. In these embodiments, the surgical tool can be configured to supply at least one actuation motion to an end effector. Further, in these embodiments, the surgical tool can be configured to perform an intended surgical function. Moreover, in these embodiments, the surgical test device can be configured to permit the surgical tool to supply the at least one actuation motion while preventing the surgical tool from performing the intended surgical function.

In various embodiments, a surgical test device is provided. In at least one embodiment, the surgical test device can comprise a body that is sized and configured to engage an end effector of a surgical tool and a release member that is coupled to the body. In these embodiments, the body can lack sealing member openings and the release member can be configured to engage a lockout mechanism on the surgical tool.

In at least one embodiment, a surgical test device is provided that can comprise a body and a release member that is coupled to the body. In these embodiments, the body can comprise at least two side walls and a bottom wall. Further, in these embodiments, the side walls can extend from the bottom wall. Additionally, in these embodiments, the side walls and the bottom wall can define a cavity, and the cavity can be sized and configured to receive at least a portion of an end effector of a surgical tool. Moreover, in these embodiments, the release member can be configured to engage a lockout mechanism on the surgical tool.

DETAILED DESCRIPTION

Certain embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments and that the scope of these embodiments is defined solely by the claims. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Further, where an ordering of steps in a process is indicated, such ordering may be rearranged or the steps may be carried out contemporaneously as desired unless illogical or the listed order is explicitly required. Such modifications and variations are intended to be included within the scope of the appended claims.

In the following description, like reference characters designate like or corresponding parts throughout the several views. Also in the following description, it is to be understood that terms such as “forward,” “rearward,” “front,” “back,” “right,” “left,” “over,” “under,” “upwardly,” “downwardly,” “proximally,” “distally,” and the like are words of convenience and are not to be construed as limiting terms. The description below is for the purpose of describing various embodiments and is not intended to limit the appended claims.

The various embodiments generally relate to various surgical test devices configured to override a sealing member lockout on a surgical severing and/or sealing tool, such as a surgical stapler or endocutter. Such surgical staplers may be configured to function through a natural orifice, such as the anus, mouth and/or vagina, or through an incision cut through a body wall. Further, such surgical staplers may be designed as endoscopic tools, including laparoscopic tools. In any event, a surgical test device, according to various embodiments described herein, may allow a surgeon, nurse, or other user to fire and test the surgical stapler to ensure that the device is working properly before using the stapler on a patient. As will be seen, a surgical test device may be a low-cost disposable unit that facilitates the test firing of a surgical tool for one or more actuation cycles without damaging the surgical tool or using more expensive sealing member cartridges, such as staple cartridges or similar replaceable units. A surgical test device may be removed after a brief test and replaced by an actual sealing member cartridge, such as a staple cartridge and/or fastener reload unit, prior to use on a patient.

Focusing now on one exemplary surgical stapler, the surgical stapler10depicted inFIGS. 1 and 2may comprise a handle6, a shaft8, and an end effector12connected to the shaft8. In various embodiments, the end effector12can be articulated about an articulation pivot14located in a distal portion of shaft8. One or more rotation and/or articulation controls16′,16″ may be provided adjacent to the handle6to effect rotation of the end effector12about the articulation pivot14. In the illustrated embodiment, the end effector12is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. More details regarding RF devices may be found in U.S. Pat. No. 5,403,312 and U.S. patent application Ser. No. 12/031,573, entitled “SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES,” filed Feb. 14, 2008, the disclosures of which are hereby incorporated by reference in their entireties.

The handle6of the stapler10may include a closure trigger18and a firing trigger20for actuating the end effector12. It will be appreciated that staplers having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector12. The end effector12is shown separated from the handle6by the elongate shaft8. In one embodiment, a clinician or operator of the stapler10may articulate the end effector12relative to the shaft8by utilizing the articulation controls16′ and/or16″, as described in more detail in published U.S. patent application Pub. No. 2007/0158385 A1, entitled “SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR,” by Geoffrey C. Hueil et al., which is incorporated herein by reference in its entirety. Additional details regarding articulating end effectors and their control may be found in one or more of the following U.S. patent applications, the disclosures of each being hereby incorporated by reference in their respective entireties: (1) “SURGICAL INSTRUMENT INCORPORATING AN ARTICULATION MECHANISM HAVING ROTATION ABOUT THE LONGITUDINAL AXIS”, Ser. No. 10/615,973, now U.S. Pat. No. 7,111,769, to Frederick E. Shelton, Brian J. Hemmelgarn, Jeff Swayze, Kenneth S. Wales, filed 9 Jul. 2003; (2) “SURGICAL STAPLING INSTRUMENT INCORPORATING AN ARTICULATION JOINT FOR A FIRING BAR TRACK”, Ser. No. 10/615,962, now U.S. Pat. No. 6,786,382 to Brian J. Hemmelgarn, filed 9 Jul. 2003; (3) “A SURGICAL INSTRUMENT WITH A LATERAL-MOVING ARTICULATION CONTROL”, Ser. No. 10/615,972, now U.S. Pat. No. 6,981,628, to Jeff Swayze, filed 9 Jul. 2003; (4) “SURGICAL STAPLING INSTRUMENT INCORPORATING A TAPERED FIRING BAR FOR INCREASED FLEXIBILITY AROUND THE ARTICULATION JOINT”, Ser. No. 10/615,974, now U.S. Pat. No. 7,055,731, to Frederick E. Shelton, Mike Setser, Bruce Weisenburgh, filed 9 Jul. 2003; and (5) “SURGICAL STAPLING INSTRUMENT HAVING ARTICULATION JOINT SUPPORT PLATES FOR SUPPORTING A FIRING BAR”, Ser. No. 10/615,971, now U.S. Pat. No. 6,964,363, to Jeff Swayze, Joseph Charles Hueil, filed 9 Jul. 2003.

The end effector12includes, in this example, among other things, a sealing member cartridge channel, such as staple cartridge channel22, and a pivotally translatable clamping member, such as an anvil24, which are maintained at a spacing that assures, when the anvil24is in its clamped or closed position, effective stapling and severing of tissue clamped in the end effector12. As discussed in more detail below, the staple cartridge channel22may releasably retain a staple cartridge37containing staples. The handle6includes a downwardly extending pistol grip25, towards which a closure trigger18is pivotally drawn by the clinician to cause clamping or closing of the anvil24toward the staple cartridge channel22of the end effector12to thereby clamp tissue positioned between the anvil24and channel22. The firing trigger20is farther outboard of the closure trigger18. Once the closure trigger18is locked in the closure position, the firing trigger20may rotate slightly toward the pistol grip25so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firing trigger20toward the pistol grip25to cause the stapling and severing of clamped tissue in the end effector12. In other embodiments, different types of clamping members besides the anvil24could be used. The handle6may also include an upper portion28that may sit on top of the user's hand when the user grips the pistol grip portion25with his/her hand.

It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the handle6of an stapler10. Thus, the end effector12is distal with respect to the more proximal handle6. 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 staplers are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

In operational use, referring still toFIGS. 1 and 2, the closure trigger18may be actuated first. Once the clinician is satisfied with the positioning of the end effector12, the clinician may draw back the closure trigger18to its fully closed, locked position proximate to the pistol grip25. The firing trigger20may then be actuated. The firing trigger20returns to the open position (shown inFIGS. 1 and 2) when the clinician removes pressure. A release button on the handle6, when depressed may release the locked closure trigger18. The release button may be implemented in various forms such as, for example, as disclosed in published U.S. Patent application Pub. No. 2007/0175955, entitled “SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM,” which is incorporated herein by reference in its entirety.

Referring toFIG. 4, the end effector12may include a cutting member26, comprising a knife, for example, for cutting tissue clamped in the end effector12when the firing trigger20is retracted by a user. The end effector12may also comprise means for fastening and/or sealing the tissue severed by the cutting member, such as staples, two-part fasteners, RF electrodes, adhesives, etc. More details regarding possible configurations of the end effector12may be found in the following patents and published patent applications, which are incorporated herein by reference in their entirety: U.S. Pat. No. 5,709,680; U.S. Pat. No. 5,688,270; U.S. Pat. No. 7,000,818; Pub. No. 2005/0173490 A1; Pub. No. 2006/0025809 A1; Pub. No. 2007/0102453 A1; No. 2007/0102452 A1; Pub. No. 2009/0206134 A1; and Pub. No. 2009/0206124 A1.

Referring back toFIGS. 1 and 2, the stapler10may also comprise a closure system for closing (or clamping) the end effector upon closure (or retraction) of the closure trigger18. More details regarding embodiments of an exemplary closure system for closing (or clamping) the anvil24of the end effector12by retracting the closure trigger18are provided in the following U.S. patent references, which are incorporated herein by reference in their respective entireties: Pub. No. 2004/0232196 A1; Pub. No. 2007/0175956 A1; Pub. No. 2007/0158385 A1; Pub. No. 2007/0175962 A1; U.S. Pat. No. 7,464,849; and the references cited in the paragraph above.

A longitudinally movable drive shaft located within the shaft8of the stapler10may drive/actuate the cutting member and the fastening means in the end effector12. An electric motor, located in the pistol grip portion25of the handle6of the stapler10, may be used to drive, indirectly, the drive shaft, as described further herein. In various embodiments, the motor may be a DC brushed driving motor having a maximum rotation of, approximately, 25,000 RPM. In other embodiments, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery (or “power source” or “power pack”), such as a Li ion battery, may be provided in the pistol grip portion25of the handle6adjacent to the motor. The battery supplies electric power to the motor via a motor control circuit. According to various embodiments, a number of battery cells connected in series may be used as the power source to power the motor. In addition, the power source may be replaceable and/or rechargeable. Additional details regarding surgical stapler10may be found in U.S. patent application Ser. No. 12/647,100, now U.S. Pat. No. 8,220,688, entitled “MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY,” filed on Dec. 24, 2009, the disclosure of which is hereby incorporated by reference in its entirety.

As noted above, the surgical stapler10may include a staple cartridge lockout. In particular, various components of such a lockout within and/or coupled to the end effector12may prevent the cutting member26and/or a staple driver sled38, within the end effector12, from actuating unless an unspent staple cartridge37is present in staple cartridge channel22. Exemplary lockouts and staple cartridges may be found in U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (issued as U.S. Pat. No. 7,380,695), mentioned above among others.

An exemplary staple cartridge37is illustrated inFIGS. 3-4. The staple cartridge37may be sized and configured to be received at least partially within staple cartridge channel22. The staple cartridge37may include a sled38that is configured to be driven by a cutting member26located within the end effector12. Accordingly, as cutting member26is fired and moves sled38in distal direction “DD,” staples (not shown) may be ejected from staple cavities and through sealing member or staple openings39. As used herein, a sealing member may include, but is not limited to, staples, two-part fasteners, adhesives, and the like. Accordingly, in various embodiments, a sealing member opening, such as staple openings39, may be configured to eject a sealing member therethrough.

While a staple cartridge lockout may be useful to prevent inadvertent firings of the stapler, a user, such as a surgeon or an operating room staff person, may desire to test each instrument prior to using it and/or presenting it to the surgeon. This may be especially true for electrically powered surgical instruments that require battery assembly. For example, a nurse typically runs a surgical drill for 1-3 seconds after connecting the battery and before handing the drill to a surgeon, ensuring the drill and battery are functioning properly. However, a surgical stapler, such as stapler10, may come equipped with the aforementioned safety lockout to prevent the device from functioning until it is properly and fully setup and placed in the actual surgical environment. Specifically, many instruments can only be test-fired by inserting and firing an actual fastener cartridge/reload, which could be costly and/or dangerous to do in the operating room instrument prep area (colloquially known as the “back table”). Such lockouts may prevent an operating room nurse, for example, from doing the testing necessary to gain confidence that the device is functional.

Focusing now on at least one non-limiting embodiment, as can be seen inFIGS. 5-6, a surgical instrument1is shown that may comprise a surgical tool, such as stapler10, that may be configured to supply an actuation motion or motions to an end effector12, and a surgical test device, such as test device100. As discussed above, the actuation motion(s) may cause a cutting member to move through the end effector and/or eject sealing members, e.g., staples, from the end effector. Further, the surgical tool may be configured to perform an intended surgical function, such as eject a sealing member or members from the end effector12, be passed, at least partially, through a trocar or cannula (e.g., the end effector12and/or shaft8may be sized and configured to fit through the inner lumen of a trocar), and/or receive tissue within the end effector12. Also, the surgical test device may be configured to permit the surgical tool to supply the actuation motion or motions to the end effector, while preventing the surgical tool from performing at least one of its intended surgical functions.

In more detail, in one embodiment, the surgical test device100may be releasably attached to the end effector12of a surgical stapling and/or severing tool, such as stapler10, is shown. The end effector12may comprise a cutting member. Further, the surgical stapler10may also include a lockout mechanism, discussed below, configured to prevent the cutting member26from moving within the end effector12when the lockout engages at least a portion of the cutting member26(seeFIG. 4). As used herein and as described in more detail below, the lockout mechanism may include various portions of the surgical tool, such as, but not limited to, portions of the cutting member and/or the end effector. Further, the test device100may comprise a body101releasably engaged to the end effector12. Unlike a staple cartridge, the body lack staple cavities or slots for ejecting staples therethrough, and, accordingly, the test device need not include staples. Further, also discussed in more detail below, a release member may be coupled to the body and be configured to engage at least a portion of the lockout mechanism to prevent the lockout mechanism from engaging the cutting member26, thereby allowing one to test fire the surgical stapler10, without fear of ejecting a sealing member or members, such as staples, therefrom.

The surgical test device100may further prevent or reduce the probability that the device will be improperly used without an unspent staple cartridge. For example, referring toFIGS. 5 and 6, the test device100, owing to its relative size and when attached to a surgical stapling and/or severing tool, such as stapler100, may prevent the end effector12from being inserted into and/or through a trocar. In more detail, the surgical test device may further comprise a bottom wall105and at least one side wall, such as side walls102and103, extending from the bottom wall101. Further, an end wall, such as end wall104, for example, may also extend from the body101and connect with side walls102,103. The bottom wall may be adjacent to the staple cartridge channel22and the side walls and/or end wall104may extend past staple cartridge channel22toward and/or past anvil24. Referring briefly toFIG. 9, the side walls102,103, end wall104, and/or bottom wall105may define a cavity106that is sized and configured to receive at least a portion of the end effector12. In any event, referring back toFIGS. 5 and 6, the side walls102,103and/or end wall104may be size and configured to be larger than a trocar through which end effector12(when closed) and/or shaft8may normally, absent test device100, fit. In other words, the side walls102,103and/or end wall104may serve as a guard against inserting the surgical instrument1through a trocar until a user removes test device100and inserts an unspent staple cartridge37(seeFIGS. 3-4).

Additionally, the surgical test device100may help prevent or reduce the probability that a user or another person may be unintentionally injured by the stapler10, or that a patient's tissue is cut without sealing members, e.g., staples, in the stapler10. Referring toFIGS. 7 and 8, the surgical test device100is shown in transparency for clarity. The test device100is attached to the end effector12, which is shown in an open position (FIG. 7) and a closed position (FIG. 8). As can be seen, the end effector's two jaw members, e.g., staple cartridge channel22and anvil24, are movable between the aforementioned open and closed positions and at least one of side walls102,103and/or end wall104may be sized and configured to cover the staple cartridge channel22and anvil24when the channel22and24are in the open position. In other words, one or more of side walls102,103and/or end wall104may extend away from the bottom wall105, past the open position (FIG. 7) of the anvil24. Further, one or more of side walls102,103may have a sloped profile, as shown, that correlates with the open position of the anvil24. The angle of the walls' profile may be substantially equal to the angle of the open position of the anvil24. These angles may be measured with respect to the bottom wall105and/or staple cartridge channel22, which may be substantially parallel in orientation. Such a sloped profile of side walls102,103may reduce the amount of material needed to manufacture surgical test device100. In any event, the side walls102,103, and/or end wall104may serve as a guard to ensure that an unintended object, such as a patient's tissue and/or a non-patient's finger, for example, are not inserted into the surgical stapler10while the test device100is positioned on end effector12. Accordingly, one may be protected from the cutting member26(seeFIG. 4) and/or other sharp features of the end effector12.

The surgical test device100may be further configured to disable a lockout feature of the surgical stapler10. For example, the test device100may include a release member, such as release member107, that may be coupled to the body101and be configured to engage the lockout to prevent the same from engaging the cutting member, thereby allowing one to test fire the stapler10without wasting a staple cartridge37(seeFIGS. 3-4). Referring toFIG. 9, a top perspective view of the surgical test device100is shown unattached to an end effector.FIG. 10also shows a side cross-sectional view of the surgical test device100attached to an end effector12of surgical stapler10(seeFIGS. 1-2). InFIG. 10, two jaw members, e.g., staple cartridge channel22and anvil24, and a cutting member26are illustrated; however, various additional components are omitted for the purposes of clarity. Additional exemplary details regarding such components may again be found in U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (issued as U.S. Pat. No. 7,380,695), noted above. Further, the cutting member26is shown in transparency in FIGS.10and12-13C for the purposes of clarity. Referring toFIGS. 9 and 10, the release member107may protrude from the bottom wall105of body101. The release member107may be separately formed and then attached to the body101, or the release member107may be unitary and integrally formed from the same piece of material as the body101. Regardless, release member107may be positioned and configured to engage at least one component of a lockout mechanism of a surgical stapling and/or severing tool, such as stapler10(seeFIGS. 1-2).

In more detail, portions of such a lockout mechanism may be best seen inFIGS. 11-12.FIG. 11shows a partial perspective cross-sectional view of the surgical test device100attached to the end effector10of the surgical stapler10. The cutting member26may be coupled to a firing bar29that is configured to apply an actuation or firing motion, to push, or to otherwise move the cutting member in a distal direction DD when the firing trigger20(seeFIGS. 5-6) is actuated. Further, the firing bar may retract the cutting member26to a starting position shown inFIGS. 10 and 11, for example, upon completion of the firing stroke. The firing bar29may be biased toward the bottom of the staple cartridge channel22by a spring, such as leaf spring31that slidingly contacts a portion of firing bar29. Further, the cutting member26may include wings or pins27that extend laterally therefrom. Thus, when the firing bar29drives the cutting member26in the distal direction DD, the cutting member26, at least initially, and the pins27are driven towards the bottom of staple channel22.

The staple channel22may further include a lockout trough23located near the starting position of the cutting member26that is sized and configured to receive the pins27. Accordingly, when the cutting member26is moved distally from the starting position shown inFIGS. 10 and 11, the pins27may become lodged or otherwise stuck in trough23, thereby preventing further distal movement of the cutting member26, seeFIG. 12.FIG. 12illustrates the cutting member26resting in the lockout trough23in a locked position.

In normal use, referring toFIGS. 3 and 11, when a staple cartridge37is inserted in staple cartridge channel22, a notch32at the distal portion of cutting member26may engage sled38and thereby prevent the pins27from moving into lockout trough23. Further exemplary details regarding overcoming the lockout mechanism with a staple cartridge may be found in the above mentioned U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (issued as U.S. Pat. No. 7,380,695).

In at least one embodiment, the lockout may be overcome by the surgical test device100. In other words, the surgical test device100may prevent the pins27from becoming lodged in lockout trough23. Referring now toFIGS. 13A-13C, the surgical test device100is shown attached to the end effector12as the cutting member is moved into a release member of the test device and over the lockout trough. In more detail,FIG. 13Ashows the cutting member26in a starting position, as mentioned above.FIG. 13Bshows the cutting member26as it is being advanced in a distal direction DD. The cutting member26and pins27are being biased towards lockout trough23by spring29(seeFIG. 11). However, as the pins27commence to enter the trough23, a bottom portion30of cutting member26contacts a ramp or inclined surface108of release member107. As the cutting member26is further fired in the distal direction DD, the cutting member26may slide up the inclined surface108to prevent the pins27from engaging the lockout trough23.FIG. 13Cshows the cutting member26as it is further advanced distally such that the bottom portion30slides along a plateau or elevated surface109formed in the body101, for example, thereby allowing the cutting member26to smoothly move through the end effector12.

While the cutting member26is moving distally through the end effector12, a user may wish to observe or otherwise confirm the cutting member's travel therethrough, to ensure that the surgical stapler10(seeFIG. 5) is functioning appropriately. Accordingly, in various embodiments, the surgical test device100may include features to inform a user that the stapler10is properly firing. In at least one embodiment, the user may visually see the cutting member26move. For example, referring again toFIG. 9, the test device100may include openings or slots111defined by end wall104and/or bottom wall105. Further, referring toFIGS. 11 and 12, for example, the bottom portion30of the cutting member may be externally accessible and/or visible through a slot in the bottom of staple channel22. Thus, when viewed from the underside, the advancement of cutting member26, while surgical test device100is attached to end effector12, may be at least partially viewed through slots111(seeFIG. 9). Further, the body101may be transparent, thereby allowing one to also see the cutting member26move through the end effector12through one or more of walls102,103,104, and105.

The surgical test device100may be releasably engaged to an end effector12as follows. Flex or snap tabs110may be attached to, formed in, and/or defined by side walls102,103. Each tab110may be configured to releasably engage a portion of the end effector12, such as staple cartridge channel22(seeFIG. 10) and cooperate with bottom wall105to hold the end effector12thereto. Accordingly, referring toFIGS. 9 and 10, the end effector12may be pressed into cavity106until tabs110snap onto the staple cartridge channel22, for example. The tabs110may also be configured to resist the forces created when the cutting member26contacts the release member107, and thereby hold the test device100in place during firing of the cutting member26.

Removing the surgical test device100from the end effector may be effectuated by pulling, twisting, and/or otherwise dislocating the tabs110from the end effector12. In at least one embodiment, the test device's body101may be flexible and/or made of a resilient plastic material or materials. Further, the slot111defined by end wall104may be open at the top of the test device100, seeFIG. 9, thereby better allowing the body101to be pealed off the end effector12, owing to separation between portions of end wall104. Also, the test device100may further comprise at least one finger tab or grip112extending from the at least one side wall such that a user may grip the test device100and apply the aforementioned pealing motion.

Referring still toFIG. 9, the surgical test device may also include positioning tabs113extending from the side walls and configured to slidably engage the anvil24when the anvil is opened and closed, seeFIGS. 7-8. Positioning tabs113may help align the distal portion of the test device when opening and closing the anvil24with respect to the staple cartridge channel22.

Referring toFIGS. 9 and 10, when firing the surgical stapler10, the side walls102,103may tend to flex near the release member107as the cutting member26is advanced over the release member107, jeopardizing clearance of the lockout trough23by pins27. Accordingly, the surgical test device may further comprise at least one reinforcing rib114connected to and/or formed in the side walls102,103. To overcome the aforementioned flexing, the reinforcing ribs114may also be located at the same longitudinal position along the body101as where the release member is located, seeFIG. 10.

Further, referring again toFIG. 9, to better maintain position and alignment at the distal portion of the test device100when the release member107is engaged by cutting member26, a raised surface115including a boss116extending from the bottom wall105may be incorporated and/or attached to the body101. Referring toFIGS. 9 and 10, when the end effector12is received in cavity106, the outer surface of staple cartridge channel22may nest on raised surface115(seeFIG. 9) and the boss116may engage a bottom groove of the channel22(seeFIG. 10). Also, as the cutting member26engages the release member107, the distal portion of the test device100may be urged upwards; the boss116and/or raised surface115accordingly may help prevent the test device100from moving undesirably during actuation of the cutting member over the lockout trough23(seeFIGS. 13B-13C) by stabilizing the distal portion of the test device100against the end effector12.

Additionally, the surgical test device100, in at least one embodiment may also include one or more of the following. The surgical test device100may be attached to a surgical tool, such as stapler10(seeFIG. 5), before shipping the stapler10to a user. Thus, the test device100may also help protect the end effector12during storage and/or shipment. Also, the surgical test device may be clearly marked for use in test firing only and/or for disposal prior to surgical use.

In various embodiments, a surgical test device may include features to benefit a surgical tool with an articulating end effector. For example, referring now toFIGS. 14-16, various views of a surgical test device200are provided.FIG. 14is a perspective view the test device200,FIG. 15is a side cross-sectional view of the test device200, andFIG. 16is a bottom view of the surgical test device200. The test device200may be similar to that described above and may include release member207extending from body201, a finger grip (with a visual instruction, “PULL”) also extending from the body201, and slots211defined in the body211(seeFIG. 16). However, the surgical test device may further comprise a panel218hingedly mounted to a proximal portion217of the body201. The panel218may be hingedly mounted to the proximal body portion217by a living hinge219or other known hinges, for example. While the panel218is shown in an open position inFIGS. 14-16, the panel218may be configured to cover an articulation pivot, such as articulation pivot14adjacent to end effector12of surgical stapler10(seeFIGS. 1-2), for example, when in a closed position and when the surgical test device200is releasably engaged to the end effector, as described above. The panel218may also include a lip220extending therefrom that is configured to engage the proximal body portion217when the panel218is closed, to create a releasable snap fit.

Referring toFIGS. 1-2and14, the panel218may serve at least two functions. First, the panel218, when closed and in conjunction with proximal body portion218, may assist in protecting the articulation pivot14during transportation and/or storage of the surgical stapler10, for example. Second, the panel218, again when closed and in conjunction with proximal body portion218, may also help contain or hold lubricant against the articulation pivot14, until the stapler10is ready for use in a patient, at which point, the panel218may be opened as seen inFIG. 14, for example, and the test device200removed from the stapler10by pulling the finger grip212away from the stapler10.

In various embodiments, a surgical test device may engage the lockout mechanism of a surgical tool differently than that described above. For example, while the above-described release members engaged the lockout mechanism of stapler10by protruding from outside the end effector12and through the staple cartridge channel22(see, e.g.,FIG. 10), a surgical test device may include a release member that is configured to engage the lockout mechanism without passing through the staple cartridge channel22, in a manner that may be at least partially similar to the way that a regular, unspent staple cartridge prevents the lockout from functioning.

In at least one embodiment and referring toFIGS. 17-18, a surgical test device300may include a body301that is sized and configured to fit within a staple cartridge channel22(seeFIG. 10) in place of a staple cartridge37(seeFIG. 4).FIG. 17is a top perspective view of the surgical test device300andFIG. 18is a bottom perspective view of a proximal portion of the test device300. The surgical test device300may further comprise a release member307that includes a projection322extending from a cantilevered arm321formed in body301. Further, the projection322, cantilevered arm321, and/or body301may define a slot that is sized and configured to receive cutting member26therethrough (see, again,FIG. 4).

The release member307may engage the lockout mechanism of a surgical tool, such as stapler10, as follows. Referring toFIG. 17for test device300andFIG. 11for the stapler's components, when test device300is inserted in staple cartridge channel22, the notch32at the distal portion of cutting member26may engage release member307at projection22and thereby prevent the pins27from moving into lockout trough23. As the cutting member26is advanced in a distal direction DD, the cantilevered arm321may flex away from the cutting member26, thereby allowing the cutting member26to pass. After the cutting member26passes the projection22, the cantilevered arm26may resiliently bend back into the initial position seen inFIG. 18, for example. Accordingly, as with test devices100and200, discussed above, the test device300may be used multiple times within the same surgical stapler10. Notably, the projection322may be positioned with respect to body301such that the projection322may engage the cutting member notch32before the cutting member pins27move into or otherwise engage the lockout trough23. Also, as can be seen inFIG. 17, the body301does not include any staple cavities or openings therein.

Further, referring toFIG. 17, the surgical test device300may further include walls302,303, and304formed at the distal portion of the body301. As can be seen, the side walls302and303may only extend partially along the length of an end effector12(seeFIG. 1). Accordingly, owing to the lack of a wall along the length of an end effector, a user may not only observe a cutting member moving through an end effector from the bottom of the end effector, but he or she may also directly observe a cutting member moving from the side of the end effector.

In at least one embodiment, referring toFIGS. 19-20, a surgical test device, such as surgical test device400, may be similar to a staple cartridge37(seeFIGS. 3-4), except at least that the test device400does not include staple cavities, staple openings, or staples or any other form of a sealing member cavity, sealing member opening, or sealing member(s). Additional details regarding a staple cartridge may be found in the aforementioned U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (issued as U.S. Pat. No. 7,380,695). In more detail, referring back toFIGS. 19-20, the surgical test device400may include a body401that is sized and configured to engage a staple cartridge channel22. In particular, the body401is designed to fit at least partially within the staple cartridge channel22and may comprise a lower portion401aand an upper portion401b. Further, the body401lacks staple or sealing member openings defined in upper surface423. Referring toFIG. 19, the test device400may further include a release member407coupled to the body that is configured to engage a lockout on a surgical severing and/or sealing device, such as stapler10(seeFIG. 20). As can be seen inFIG. 19, the release member407may comprise a movable member, such as sled425, held between lower and upper body portions,401aand401b, respectively. The movable sled425may be similar to sled38discussed above with respect to staple cartridge37(seeFIG. 3). In any event, referring toFIGS. 11 and 19, the sled may include a release surface424that is configured to engage the notch32at the distal portion of cutting member26as the cutting member26is advanced in a distal direction DD and thereby prevent the pins27from moving into lockout trough23. As the cutting member26is driven distally, the sled425may be unable to return to the initial position shown inFIG. 19, and thus the surgical test device400may be a single use device. Limiting the test device400to a single use may be beneficial to help protect the battery life of an electrically powered surgical stapler, such as stapler10, as the lockout mechanism may then re-engage the cutting member once the cutting member is returned to it its starting position, as described above.

While surgical test device400may include at least three parts (i.e., lower body portion401a, upper body portion401b, and sled425), a surgical test device including a movable sled may only have two parts: a body and a movable sled. For example, in at least one embodiment and referring toFIG. 21, a side perspective view of a surgical test device500is shown. Similar to surgical test devices300and400, described above, the surgical test device500may include a body501sized and configured to at least partially fit inside and engage a cartridge channel of a surgical severing and/or sealing device, such as stapler10(seeFIG. 1). Further, the body501does not have staple cavities, staple openings, or staples or any other form of a sealing member cavity, sealing member opening, or sealing member(s). The surgical test device500may further include a release member507coupled to the body that is configured to engage a lockout on the surgical stapler10. Similar to that described above, the release member507may be a movable member, such as sled525. However, body501may be a single piece and movable sled525may be slidably engaged in a slot511defined by body501. For example, the sled525may include snap-fit features to allow the sled525to be snapped into slot511. In any event, sled525may at least slide in a distal direction DD along slot511. In use, the sled525may function similar to sled425, described above, at least in that the sled525may include a surface (not shown) that is configured to engage the notch32on cutting member26such that the pins27do not engage the lockout trough23(seeFIG. 11) as the cutting member is advanced in the distal direction DD. Again, as the cutting member is driven distally, the sled525may be unable to return to the initial position shown inFIG. 21, and thus the surgical test device500may be a single use device and provide various related advantages.

The surgical test device500may include walls502,503, and504, similar to that discussed above. At least one wall, such as wall502may include a symbol526formed, printed, and/or attached thereon that indicates to a user that the test device500is disposable.

While the embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to the embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the various embodiments. For example, according to various embodiments, a single component or step may be replaced by multiple components or steps, and multiple components or steps may be replaced by a single component or step, to perform a given function or functions or accomplish a given objective. Further, the various components described above may be made from a variety of materials. For example, the components may be made from any combination of metal, plastic, and/or a biocompatible material. Additionally, while in at least one embodiment, an electrically powered surgical stapler10is described for use with a surgical test device, a surgical test device, according to one or more of the various embodiments described herein, may be used with a manually powered surgical severing and/or sealing instrument, such as the surgical stapler described in U.S. patent application Ser. No. 10/687,503, entitled “SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING,” to Doll et al. (issued as U.S. Pat. No. 7,380,695), mentioned above. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the appended claims.