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Endoscopic surgical instrument with pivotable and rotatable staple cartridge    
United States Patent5431323   
Link to this pagehttp://www.wikipatents.com/5431323.html
Inventor(s)Smith; Jack E. (Dayton, OH); Bedi; James J. (Cincinnati, OH); Sierocuk; Thomas J. (Blue Ash, OH); Graves, Jr.; Thomas H. (Milford, OH)
AbstractA surgical instrument is provided which is insertable through an endoscopic tube to enable a surgeon to perform a surgical technique inside a body cavity. The surgical instrument includes a shaft with a pivotally mounted tip attached thereto, the shaft extending from a handle for gripping the instrument for insertion to the body cavity. The tip of the shaft is adjustable to different angular orientations relative to the support shaft and is rotatable at any angular orientation of the tip. The support shaft may be rotatable about its longitudinal axis relative to the handle, or it may be fixed with respect to the handle, in which case the handle may be rotated to rotate the shaft inside the body cavity. In one embodiment, the surgical instrument comprises an endoscopic stapling device and the tip of the instrument comprises a staple cartridge which is rotatable 360.degree. about its axes after the cartridge has been articulated with respect to the support shaft. An improved device for articulating the shaft tip is also provided in which a control knob is mounted to the support shaft for providing sweeping articulation of the shaft tip. Separate actuator mechanisms are provided on the handle to control the pivotal movement of the shaft tip, as well as the rotation of the shaft tip and the rotation of the support shaft.
   














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Drawing from US Patent 5431323
Endoscopic surgical instrument with pivotable and rotatable staple

     cartridge - US Patent 5431323 Drawing
Endoscopic surgical instrument with pivotable and rotatable staple cartridge
Inventor     Smith; Jack E. (Dayton, OH); Bedi; James J. (Cincinnati, OH); Sierocuk; Thomas J. (Blue Ash, OH); Graves, Jr.; Thomas H. (Milford, OH)
Owner/Assignee     Ethicon, Inc. (Somerville, NJ)
Patent assignment
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Publication Date     July 11, 1995
Application Number     08/080,462
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     June 21, 1993
US Classification     227/177.1 227/19 227/182.1
Int'l Classification     A61B 017/068
Examiner     Rada; Rinaldi I.
Assistant Examiner    
Attorney/Law Firm     Coletti; Paul A.
Address
Parent Case     This application is a continuation-in-part of Serial No. 959,184, filed Oct. 9, 1992, entitled "Endoscopic Surgical Instrument with Pivotable and Rotatable Staple Cartridge", now U.S. Pat. No. 5,381,943.
Priority Data    
USPTO Field of Search     227/19 227/175 227/177 227/178 227/180 227/181 227/176 227/182
Patent Tags     endoscopic surgical instrument pivotable rotatable staple cartridge
   
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McGarry

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 Technical Review Submit all comments and votes
 Claims Submit all comments and votes
 


We claim:

1. A surgical stapling instrument for applying one or more surgical staples to tissue, comprising:

a handle including a staple actuator mechanism;

a tubular support shaft defining a first longitudinal axis and a circumferential cross-section and extending from said handle;

a staple cartridge mounted on said support shaft and connected to said staple actuator mechanism for applying one or more staples to the tissue;

said staple cartridge being mounted for articulatable movement relative to said support shaft about an axis of articulation, said axis of articulation being transverse to said longitudinal axis of said support shaft;

said staple cartridge having a circumferential cross-section no greater than said shaft cross-section;

said support shaft being either rotatable about said first longitudinal axis or fixed relative to said handle, said staple cartridge being rotatable relative to said shaft about a second longitudinal axis defined by said staple cartridge;

a cartridge rotating means for accommodating rotation of said cartridge relative to said support shaft about said second longitudinal axis of said cartridge;

first means formed from a memory metal for articulating said staple cartridge about said axis of articulation, wherein said first means also comprises a means for providing a staple driving force to said staple cartridge to drive staples contained in said staple cartridge.

2. The stapling instrument of claim 1 which includes:

second means for rotating said support shaft about its longitudinal axis.

3. The stapling instrument of claim 1 wherein said first means comprises a memory metal band having a permanent bend in one end thereof for articulating said staple cartridge as said band is slid with respect to said staple cartridge.

4. A surgical stapling instrument for applying one or more surgical staples to tissue, comprising:

a handle including a staple actuator mechanism;

a tubular support shaft defining a first longitudinal axis and a circumferential cross-section and extending from said handle;

a staple cartridge mounted on said support shaft and connected to said staple actuator mechanism for applying one or more staples to the tissue;

said staple cartridge being mounted for articulatable movement relative to said support shaft about an axis of articulation, said axis of articulation being transverse to said longitudinal axis of said support shaft;

said staple cartridge having a circumferential cross-section no greater than said shaft cross-section;

said support shaft being either rotatable about said first longitudinal axis or fixed relative to said handle, said staple cartridge being rotatable relative to said shaft about a second longitudinal axis defined by said staple cartridge;

a cartridge rotating means for accommodating rotation of said cartridge relative to said support shaft about said second longitudinal axis of said cartridge; and

wherein said stapling instrument includes means for providing rotational motion of said staple cartridge, comprising torque transfer means rotatably positioned within said support shaft, said torque transfer means being fastened at its distal end to said rotatable staple cartridge via flexible attachment means, said torque transfer means being attached at its proximal end to external torque transfer means.

5. The surgical stapling instrument of claim 4, said flexible attachment means comprising flexible cable means adapted for flexing through any said angle of articulation of said staple cartridge and for transferring torque from, and initiated at, said external torque transfer means to said rotatable staple cartridge.

6. The surgical stapling instrument of claim 5, wherein said flexible cable means is fabricated from material selected from the group consisting of wire, rod, chain, flex shaft, and multi-strand cable.

7. The surgical stapling instrument of claim 4, wherein said flexible cable means is fastened at its distal end to said rotatable staple cartridge and fastened at its proximal end to a rigid portion of said torque transfer means.

8. The surgical stapling instrument of claim 7, wherein said rigid portion comprises a rod rotatably disposed within said support shaft.

9. The surgical stapling instrument of claim 5, wherein said flexible cable is slidably positioned within a flexible conduit.

10. A surgical stapling instrument for applying one or more surgical staples to tissue, comprising:

a handle including a staple actuator mechanism;

a tubular support shaft defining a first longitudinal axis and a circumferential cross-section and extending from said handle;

a staple cartridge mounted on said support shaft and connected to said staple actuator mechanism for applying one or more staples to the tissue;

said staple cartridge being mounted for articulatable movement relative to said support shaft about an axis of articulation, said axis of articulation being transverse to said longitudinal axis of said support shaft;

said staple cartridge having a circumferential cross-section no greater than said shaft cross-section;

said support shaft being either rotatable about said first longitudinal axis or fixed relative to said handle, said staple cartridge being rotatable relative to said shaft about a second longitudinal axis defined by said staple cartridge;

a cartridge rotating means for accommodating rotation of said cartridge relative to said support shaft about said second longitudinal axis of said cartridge;

wherein said cartridge rotating means is operable from a location proximally of said cartridge for providing rotational motion of said staple cartridge, and comprises torque transfer means rotatably positioned within said support shaft, said torque transfer means being fastened at its distal end to said rotatable staple cartridge via flexible attachment means, said torque transfer means being attached at its proximal end to external torque transfer means, said torque transfer means further comprising staple driver means;

means for articulating said staple cartridge about said axis of articulation comprising means for providing pushing and/or pulling forces in a direction generally parallel to said support shaft and for directing said forces around clevis means for pivoting said staple cartridge about said axis of articulation;

wherein said means for articulating said staple cartridge comprises an articulation driver means slidably positioned in said support shaft and spaced from said torque transfer means; and further including spacer means for maintaining spacing between said torque transfer means and said articulation driver means.

11. The surgical stapling instrument of claim 10, wherein said articulation driver means comprises a rigid section having fastened to its distal end a flexible member, said flexible member providing both sufficient flexibility for bending about said axis of articulation and sufficient stiffness and tensile strength for transferring pushing and pulling forces, respectively, around said clevis means.

12. The surgical stapling instrument of claim 11, wherein said flexible member comprises a flexible cable.

13. The surgical stapling instrument of claim 12, wherein said flexible cable is fabricated from material selected form the group consisting of wire, rod, chain, flex shaft, and multi-strand cable.

14. The surgical stapling instrument of claim 12, wherein said flexible cable is fabricated from material selected from the group consisting of steel, nitinol, nylon, and fiberglass.

15. The surgical stapling instrument of claim 11, wherein said instrument further includes:

a control means mounted externally on said support shaft proximate said handle for transferring motion to said articulation driver means in a longitudinal direction generally parallel to the longitudinal axis of said support shaft.
 Description Submit all comments and votes
 


FIELD OF THE INVENTION

This invention relates to surgical instruments having an articulating end pivotally connected to a shaft, wherein the articulating end may be rotated about a longitudinal axis over a plurality of angles of articulation with respect to the longitudinal axis of the shaft. More specifically, the present invention relates to endoscopic instruments such as a surgical stapling instrument for applying surgical staples to internal body tissue and, more particularly, to a surgical stapler which can be used endoscopically for the repair of hernias. Most specifically, this invention relates to an endoscopic surgical stapling instrument including a staple cartridge which is pivotally and rotatably mounted to allow the surgical staples to be applied to the internal body tissue in any desired orientation. Additionally, the present invention relates to an improved mechanism for providing articulation to the articulating end of the instrument.

BACKGROUND OF THE INVENTION AND PRIOR ART

With the proliferation of endoscopic surgery, it has been realized that there are many procedures typically performed in open surgery which can be performed endoscopically. In endoscopic surgery, a trocar, which is a pointed piercing device, is inserted into the body with a cannula placed around the trocar. After the trocar pierces the body cavity walls, it is removed and the cannula remains in the body. Through this cannula, endoscopic procedures can be conducted. Generally, the endoscopic procedures are performed under insufflation. Some of the more typical endoscopic procedures have included gall bladder removal, tissue repair, and sterilization procedures such as occluding of fallopian tubes.

Surgeons realize that it may be possible to perform additional procedures endoscopically, once the proper materials and mechanisms become available for performing these procedures. One of the more basic, and quite logical extensions of current endoscopic procedures has been focused on the repair of hernias. It is realized that to have the capability of performing hernia repair endoscopically will benefit the medical community in many ways. Specifically, it is realized that endoscopic hernia repair will allow the patient to recuperate more rapidly, and without the more than likely extensive physical therapy currently practiced as a result of a hernia repair performed by open surgery.

Moreover, it is realized that hernia repair procedures may contain aspects which are applicable in other procedures. For instance, if it is possible to cover, or reinforce and constrain a hernia, it may be possible to apply this procedure to other vessels or organs, in a similar manner. Also, it is realized that once a device becomes available wherein hernias can be repaired, many of the functional components of the hernia repair device will be useful in other devices capable of performing other procedures. Also, naturally, these mechanisms may be useful for procedures in which open surgery is performed.

In response to the above described needs, a number of surgical instruments have been developed for use in endoscopic stapling procedures. One such device, copending U.S. patent application Ser. No. 759,014, filed Sep. 12, 1991, Attorney Docket No. SEN-83, expressly incorporated in its entirety by reference herein, discloses a surgical stapler having a rigid, rotatable shaft containing a stack of staples aligned in a horizontal plane with respect to the shaft. This mechanism has proven quite effective in performing endoscopic surgical procedures; it does not, however, offer means for articulating the tip of the shaft containing the staples in response to a surgeon's need to alter the orientation of the device once it has been inserted into the patient.

Copending U.S. patent application Ser. No. 959,184 (END-26), also expressly incorporated in its entirety by reference herein, discloses an endoscopic surgical device which includes an articulating tip allowing the surgeon to articulate a staple cartridge after the device has been inserted into the patient. The staple cartridge includes a stack of staples oriented in a vertical plane, which allows for a more efficient packing of staples in the device.

Although the articulation device of the aforedescribed application is effective ill providing articulation of the tip of the shaft, it is limited to providing a predetermined number of angles of articulation by use of a ratchet mechanism. Occasionally, the ratchet mechanism may bind and become difficult to operate smoothly.

It would, therefore, be useful to provide an endoscopic surgical instrument that is capable of having an articulatable tip that could be rotated about its longitudinal axis in a plurality of angles of articulation with respect to the shaft. Additionally, a significant advance in the art would be realized if a new articulation device could be developed to better solve the aforementioned problems of ratchet-type articulation.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide an endoscopic surgical stapler for applying staples to secure a hernia repair patch to internal body tissue.

Another object of the invention is to provide an endoscopic surgical stapler including a staple cartridge which is pivotally and rotatably mounted to allow the staples to be fastened to the tissue in any desired orientation.

It is also an object of the invention to provide an endoscopic surgical stapling instrument in which the pivotal movement and rotation of the staple cartridge can be controlled from a remote actuator handle assembly.

It is another object of the invention to provide an endoscopic surgical stapling instrument which facilitates manipulation by a surgeon to control the orientation and actuation of the staple cartridge.

A further object of the invention is to provide a staple cartridge for use with a surgical stapling instrument which includes an improved staple forming mechanism for advancing the staples one at a time into engagement with an anvil about which the staple is formed to secure the staple to the tissue.

Yet another object of the invention is to provide an endoscopic surgical instrument having an articulatable tip, which tip may be rotated 360.degree. about its axis after the tip has been articulated with respect to the longitudinal axis of the shaft to which it is pivotally connected.

It is still another object of the invention to provide a retrofittable device for use on existing articulatable endoscopic surgical instruments for providing the aforedescribed 360.degree. rotation of the tip of the device after articulation.

It is still a further object of the invention to provide a mechanism for smoothly articulating the tip of the instrument in a sweeping, as opposed to a ratcheting, motion.

The aforedescribed objects are satisfied with the present invention, which includes a device for providing rotational motion to the distal end of any surgical instrument having a shaft for introducing surgical apparatus to a patent. The shaft of the instrument includes an articulatable tip which, as previously described, may be rotated about its axis after the tip has been articulated with respect to the shaft longitudinal axis. Surgical apparatus which may be used in connection with the shaft include cannulas, cameras, staplers, ligation devices, forceps, drills, suction devices, insulation devices, cutting devices, scalpel devices, clamps, absorption devices, injection devices, drainage devices, lasers, cryogenic devices, sonic devices, illumination devices, and stitching devices. In the aforedescribed surgical instruments, devices similar to those previously described are employed to provide the desired rotational movement of the articulatable tip of the surgical instrument shaft.

In another embodiment of the invention, the invention is adapted to provide rotational motion to a rotatable, articulatable staple cartridge of a surgical stapling instrument having a support shaft supporting the staple cartridge. The stapling instrument includes a pivot for pivoting the staple cartridge relative to the support shaft, and the staple cartridge has a longitudinal axis forming an angle of articulation relative to an axis passing longitudinally through the support shaft. The device of the invention allows the staple cartridge to be rotated about its longitudinal axis over a plurality of angles of articulation of the staple cartridge after the staple cartridge has been articulated with respect to the support shaft.

In one preferred embodiment of the invention, the device includes a first external sleeve rotatably positioned on the support shaft and a second external sleeve positioned on and engaging the staple cartridge. The first external sleeve has a distal end terminating proximate the pivot and the second external sleeve has a proximal end terminating proximate the pivot. The distal and proximal sleeve ends of the first and second sleeves engage one another for transferring rotational motion from the first external sleeve to the second external sleeve and to the staple cartridge.

In another preferred embodiment of the invention, the distal and proximal sleeve ends comprise interconnecting teeth positioned about the external sleeves. In another embodiment of the invention, the distal and proximal sleeve ends comprise frictional annular flanges. In yet another embodiment of the invention, the first and second sleeves are connected with a series of flexible film strips that are adhesively connected to the ends of the first and second sleeves.

In yet another preferred embodiment of the invention, a stapling instrument is provided having an improved articulation device that includes a control knob rotatably mounted to the support shaft proximate the handle of the instrument. The device further includes a mechanism for transferring rotational motion of the control knob to an articulation driver in a longitudinal direction generally parallel to the longitudinal axis of the support shaft. The device further includes a flexible cable slidably positioned within the support shaft and connected at one end to the articulation driver and connected at its other end to the staple cartridge at a point spaced from the longitudinal axis of the staple cartridge.

In yet another preferred embodiment of the invention, the control knob includes a worm gear for transferring rotational motion about the axis of the control knob to the articulation driver.

In another preferred embodiment of the invention, the articulation driver includes a sleeve rotatably positioned on the support shaft, having an annular channel therein for slidably receiving a flange connected to the articulation driver. The channel is inclined with respect to the longitudinal axis of the support shaft, thereby providing longitudinal motion of the flange and articulation driver as the sleeve is rotated by the worm gear.

The present invention further achieves an improved endoscopic surgical stapler which is adapted for insertion through an endoscopic tube or cannula into a body cavity to apply one or more surgical staples to the internal body tissue. The surgical stapling instrument includes a staple cartridge which is pivotally mounted at the distal end of a tubular support shaft extending from a handle which includes a staple actuator mechanism for actuating the staple cartridge to fasten the staples seriatim to the tissue. The staple cartridge is mounted for pivotal movement relative to the support shaft about an axis transverse to the longitudinal axis of the support shaft to permit the angular orientation of the staple cartridge to be adjusted. Also, the staple cartridge is mounted for rotation relative to the support shaft to permit the rotational orientation of the staple cartridge to be adjusted. In addition, the support shaft is rotatable about its longitudinal axis relative to the handle. These features of the stapling instrument allow the staple cartridge to be precisely aligned with the desired region of the internal body tissue to which the staple is applied. Separate actuator mechanisms are provided on the handle for controlling the rotation of the support shaft, the pivoting of the staple cartridge relative to the support shaft, and the rotation of the staple cartridge relative to the support shaft. These actuator mechanisms facilitate manipulation of the stapling instrument by a surgeon to position the staple cartridge in a desired orientation.

In accordance with one aspect of the invention, the surgical stapling instrument is provided with pivot means at the distal end of the support shaft for mounting the staple cartridge for pivotal movement about an axis transverse to the longitudinal axis of the support shaft. Actuator means is provided on the handle for pivoting the staple cartridge about the transverse axis to adjust the angular position of the staple cartridge relative to the support shaft. The stapling instrument includes means for retaining the staple cartridge in different angular positions relative to the support shaft. The staple cartridge has a staple forming mechanism which can be actuated by the staple actuator mechanism with the staple cartridge oriented in any of its different angular positions.

The surgical stapling instrument includes actuator means on the handle for rotating the support shaft about its longitudinal axis to adjust the rotational orientation of the support shaft and the staple cartridge. Also, means is provided for retaining the support shaft in different rotational positions as the support shaft is rotated about its longitudinal axis.

In a preferred embodiment of the surgical stapling instrument, the staple cartridge is mounted for rotation about its longitudinal axis relative to the support shaft. Actuator means is provided on the handle for rotating the staple cartridge to adjust the rotational position of the staple cartridge relative to the support shaft. Also, means is provided for retaining the staple cartridge in different rotational positions as the staple cartridge is rotated about its longitudinal axis relative to the support shaft.

In accordance with another aspect of the invention, a staple cartridge for use with a stapling instrument for applying one or more surgical staples to tissue comprises a cartridge housing adapted to receive a plurality of staples in a row for longitudinal movement therethrough, an anvil mounted on the housing, means for advancing the forwardmost staple in the row into engagement with the anvil, means for rotating the forwardmost staple from a transverse orientation into a longitudinal orientation as the staple is advanced toward the anvil, and means for forming the forwardmost staple about the anvil to attach the staple to the tissue. The staple advancing means comprises a staple holder slidably mounted within the cartridge housing for advancing the forwardmost staple from the row and clamping the staple against the anvil. The staple rotating means comprises ramp means on the cartridge housing for engaging and rotating the forwardmost staple into a longitudinal orientation as the staple is advanced by the staple holder. The staple forming means comprises a staple former slidably mounted within the cartridge housing for movement relative to the staple holder and adapted to form the forwardmost staple about the anvil. Preferably, the staple holder includes an ejector arm for removing the forwardmost staple from the anvil after the staple is formed.

A preferred embodiment of the staple cartridge is adapted for use with a staple having a generally U-shaped body including a crown with a central offset portion and a pair of depending legs at opposite sides of the crown. The staple cartridge comprises an elongated hollow cylindrical cartridge housing including a pair of spaced parallel guide rails therein for slidably supporting a stack of staples for longitudinal movement there along with the staple crowns resting on the guide rails and the staple legs oriented perpendicularly to the longitudinal axis of the cartridge housing. A staple follower is slidably mounted on the guide rails for urging the staples forwardly on the guide rails toward the distal end of the cartridge housing. An anvil is mounted adjacent to the distal end of the cartridge housing. A staple holder is slidably mounted between the guide rails for engaging the central offset portion of the forwardmost staple to advance the staple from the stack into engagement with the anvil. Ramp means is provided on the cartridge housing for engaging the crown of the forwardmost staple advanced by the staple holder and rotating the staple into a longitudinal orientation with the staple legs oriented parallel to the longitudinal axis of the cartridge housing. A staple former is slidably mounted between the guide rails and movable relative to the staple holder for engaging the crown of the forwardmost staple to form the staple about the anvil to attach the staple to the tissue.

In the preferred embodiment of the staple cartridge, the staple former comprises an elongated channel-shaped member including upstanding side flanges extending along its opposite sides for engaging and forming the staple. The staple holder comprises an elongated plate-like member slidably supported on the staple former and located between the side flanges. The staple holder includes a notch at its distal end for receiving the forwardmost staple to be advanced. The staple holder also includes a pusher finger at its distal end for engaging the forwardmost staple and clamping the staple against the anvil. In addition, the staple holder includes an ejector arm at its distal end for removing the formed staple from the anvil when the staple holder is retracted.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, aspects and advantages will be better understood and more readily apparent to those of ordinary skill in the art, as the following detailed description of the preferred embodiments of the invention proceeds, particularly with reference to the accompanying illustrative figures, in which:

FIG. 1 is an overall perspective view of an endoscopic surgical stapling instrument constructed in accordance with a preferred embodiment of this invention;

FIG. 2 is a partially cutaway side view of the stapling instrument of FIG. 1;

FIG. 3 is an enlarged longitudinal section of the stapling head and cartridge assembly of FIG. 2;

FIG. 4 is an enlarged longitudinal section of the stapling head and cartridge assembly from the opposite side of FIG. 3;

FIG. 4a is a schematic plan view of a portion of the first and second sleeves of a preferred embodiment of the invention, illustrating the interlocking teeth.

FIGS. 5 and 6 are exploded perspective views showing the components of the stapling instrument of FIG. 1;

FIG. 7 is an enlarged partially cutaway horizontal section of a portion of the stapling head assembly and support shaft of FIG. 2;

FIG. 8 is an enlarged partially cutaway vertical section of a portion of the stapling head assembly and support shaft of FIG. 2;

FIG. 9 is an enlarged, exploded perspective view showing the staple cartridge and the staple forming mechanism of the stapling head assembly;

FIG. 10 is an enlarged longitudinal section of the staple cartridge of FIG. 9;

FIG. 11 is an enlarged longitudinal section of the staple cartridge along line 11--11 of FIG. 10;

FIG. 12 is an enlarged proximal end view of the staple cartridge;

FIG. 13 is an enlarged distal end view of a portion of the stapling head assembly of FIG. 3; FIG. 14 is an enlarged fragmentary section of the staple cartridge taken along line 14--14 of FIG. 11;

FIG. 15 is a longitudinal section of a slide actuator for pivoting the stapling head assembly;

FIG. 16 is a proximal end view of the slide actuator of FIG. 15.

FIG. 17 is an enlarged plan view of a staple for use with the surgical stapling instrument of this invention;

FIG. 18 illustrates a hernia repair patch fastened to tissue with staples applied by the surgical stapling instrument of this invention;

FIG. 19 is an enlarged longitudinal section of the staple cartridge of FIG. 9 showing the staple forming mechanism in a retracted position;

FIG. 20 is an enlarged longitudinal section of the staple cartridge of FIG. 9 showing the staple forming mechanism advanced to rotate a staple into a longitudinal orientation;

FIG. 21 is an enlarged longitudinal section of the staple cartridge of FIG. 9 showing the staple forming mechanism advanced to clamp the staple against an anvil of the staple cartridge;

FIGS. 22-26 illustrate the operation of the staple forming mechanism in advancing and forming a staple;

FIGS. 27-31 are fragmentary views showing the operation of a precock ratchet mechanism in the actuator handle assembly;

FIG. 32 is an overall perspective view of an alternative embodiment of