Surgical instrument with indicator

A surgical stapling instrument including a handle assembly, an elongated body portion extending distally from the handle assembly, and a head portion. The handle assembly includes a firing trigger and a firing indicator. The firing trigger is movable between a first non-actuated position and a second actuated position. The head portion is disposed adjacent a distal portion of the elongated body portion and includes an anvil assembly and a shell assembly. The anvil assembly is movable in relation to the shell assembly between spaced and approximated positions. Engagement structure of the firing trigger moves the firing indicator from a first position to a second position when the firing trigger is moved from its first non-actuated position toward its second actuated position.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a surgical stapling instrument for applying surgical staples to body tissue. More particularly, the present disclosure relates to a surgical stapling instrument suitable with a firing indicator.

2. Background of Related Art

Anastomosis is the surgical joining of separate hollow organ sections. Typically, an anastomosis procedure follows surgery in which a diseased or defective section of hollow tissue is removed and the remaining end sections are to be joined. Depending on the desired anastomosis procedure, the end sections may be joined by either circular, end-to-end or side-to-side organ reconstruction methods.

In a circular anastomosis procedure, the two ends of the organ sections are joined by means of a stapling instrument which drives a circular array of staples through the end section of each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free the tubular passage. Examples of instruments for performing circular anastomosis of hollow organs are described for example in U.S. Pat. Nos. 6,053,390, 5,588,579, 5,119,983, 5,005,749, 4,646,745, 4,576,167, and 4,473,077, each of which is incorporated herein in its entirety by reference. Typically, these instruments include an elongated shaft having a handle portion at a proximal end to actuate the instrument and a staple holding component disposed at a distal end. An anvil assembly including an anvil rod with attached anvil head is mounted to the distal end of the instrument adjacent the staple holding component. Opposed end portions of tissue of the hollow organ(s) to be stapled are clamped between the anvil head and the staple holding component as these components are approximated. The clamped tissue is stapled by driving one or more staples from the staple holding component so that the ends of the staples pass through the tissue and are deformed by the anvil head. An annular knife is concurrently advanced to core tissue within the hollow organ to free a tubular passage within the organ.

Besides anastomosis of hollow organs, surgical stapling instruments for performing circular anastomosis have been used to treat internal hemorrhoids in the rectum. Typically, during use of a circular stapling instrument for hemorrhoid treatment, the anvil head and the staple holding component of the surgical stapling instrument are inserted through the anus and into the rectum with the anvil head and the staple holding component in an open or unapproximated position. Thereafter, a pursestring suture is used to pull the internal hemorrhoidal tissue towards the anvil rod. Next, the anvil head and the staple holding component are approximated to clamp the hemorrhoid tissue between the anvil head and the staple holding component. The stapling instrument is fired to remove the hemorrhoidal tissue and staple the cut tissue. In stapled hemorrhoidopexy, a strip of mucosa and submucosa at the top of the hemorrhoids is removed by the stapling instrument, thereby treating the hemorrhoids by inhibiting blood flow to the tissue.

In certain situations, it is desirable to provide an indication to the user regarding the firing status of the instrument. Accordingly, it would be desirable for a surgical instrument to include an indicator to let the user know when the instrument has been fired.

SUMMARY

The present disclosure relates to a surgical stapling instrument including a handle assembly, an elongated body portion extending distally from the handle assembly, and a head portion. The handle assembly includes a firing trigger and a firing indicator. The firing trigger is movable between a first non-actuated position and a second actuated position. The head portion is disposed adjacent a distal portion of the elongated body portion and includes an anvil assembly and a shell assembly. The anvil assembly is movable in relation to the shell assembly between spaced and approximated positions. Engagement structure of the firing trigger moves the firing indicator from a first position to a second position when the firing trigger is moved from its first non-actuated position toward its second actuated position.

In a preferred embodiment the firing indicator is rotatable with respect to a stationary handle of the handle assembly and includes a pawl engaged by the firing trigger when moved from its first non-actuated position toward its second actuated position. In a preferred embodiment, the engagement structure of the firing trigger includes a tab extending toward the stationary handle. The tab can be angled with respect to the longitudinal axis defined by the firing trigger.

The firing indicator preferably includes indicia thereon wherein the indicia is visible to the user when the firing indicator is in its second position.

The present disclosure also relates to a surgical stapling instrument including a handle assembly, an elongated body portion, a head portion, an approximation indicator and a firing indicator. The handle assembly includes a firing trigger. The firing trigger is movable between a first non-actuated position and a second actuated position. The elongated body portion extends distally from the handle assembly. The head portion is disposed adjacent a distal portion of the elongated body portion and includes an anvil assembly and a shell assembly. The anvil assembly is movable in relation to the shell assembly between spaced and approximated positions. The approximation indicator is disposed in mechanical cooperation with the handle assembly and is configured to move from a first position towards a second position in response to the anvil assembly moving in relation to the shell assembly towards its approximated position. The firing indicator is disposed in mechanical cooperation with the handle assembly and is configured to move from a first position towards a second position in response to the firing trigger moving towards its second actuated position.

In a preferred embodiment the firing indicator is rotatable with respect to a stationary handle of the handle assembly and includes a pawl engaged by the firing trigger when moved from its first non-actuated position toward its second actuated position. In a preferred embodiment, the engagement structure of the firing trigger includes a tab extending toward the stationary handle. The tab can be angled with respect to the longitudinal axis defined by the firing trigger.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical stapling instrument will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views.

Throughout this description, the term “proximal” will refer to the portion of the instrument closer to the operator and the term “distal” will refer to the portion of the instrument further from the operator.

FIGS. 1-3illustrate one embodiment of the presently disclosed surgical stapling instrument shown generally as reference numeral10. Briefly, surgical stapling instrument10includes a handle assembly12, an elongated body portion14including a curved elongated outer tube14a, and a head portion16. Alternately, in some surgical procedures, e.g., the treatment of hemorrhoids, it is desirable to have a substantially straight body portion. The length, shape and/or the diameter of body portion14and head portion16may also be varied to suit a particular surgical procedure.

With continued reference toFIGS. 1-3, handle assembly12includes a stationary handle18, a firing trigger20, a rotatable approximation knob22, an approximation indicator mechanism100and a firing indicator200. Head portion16includes an anvil assembly30and a shell assembly31. Anvil assembly30is movable in relation to shell assembly31between spaced and approximated positions.

Still referring toFIGS. 1-3, in operation, rotation of approximation knob22causes movement of anvil assembly30in relation to shell assembly31between spaced (FIG. 1) and approximated positions (FIGS. 2-3), as approximation knob22is operatively associated with anvil retainer38(FIG. 1), which is connected to anvil shaft or center rod33of anvil assembly30. Rotation of approximation knob22in a first direction (e.g., clockwise) causes proximal movement of anvil assembly30by retracting anvil retainer38, and rotation of approximation knob22in a second opposite direction (i.e., counter-clockwise) causes distal movement of anvil assembly30as anvil retainer38is advanced distally. Other approximation mechanisms are also contemplated.

More specifically, referring toFIGS. 4A and 4B, approximation knob22is mechanically engaged with a screw40and the screw40is in mechanical cooperation with anvil retainer38which is engaged with anvil assembly30. As shown inFIG. 4A, the proximal potion of screw40has a helical channel35and is slidably positioned within central bore33aof rotatable sleeve34. The proximal portion of sleeve34extends through an opening in the proximal end of the stationary handle18and elongated ribs39on its outer surface are received in internal slots49aof rotation knob22to fix sleeve34to knob22. A pin37extends through cylindrical collar36of sleeve34into helical channel35. Since sleeve33is axially fixed with respect to stationary handle18, rotation of sleeve34about screw40causes pin37to move along channel35of screw40to effect axial movement of screw40. Further details of the approximation mechanism are described in U.S. Pat. No. 7,303,106, the entire contents of which are incorporated herein by reference. Rotation of approximation knob22in the first direction causes the screw stop40to move proximally, which in turn causes proximal movement of anvil retainer38to approximate the attached anvil toward the fasteners.

Additionally,FIGS. 1-4show a lockout mechanism including a trigger lock50. Trigger lock50is disposed in mechanical cooperation with handle assembly12and maintains firing trigger20in an open inactivated position until anvil assembly30and shell assembly31have been approximated. With the trigger lock50in the blocking position shown inFIGS. 1 and 4B, wherein the anvil is in an unapproximated position, firing trigger20cannot be squeezed. As can be appreciated, the lockout mechanism therefore helps prevent staples from being fired prematurely, i.e. before approximation of the anvil assembly, by blocking movement of the firing trigger20.

When the rotation knob22is rotated to approximate the anvil assembly30, screw40and screw stop40move proximally, and a downwardly extending tab portion43of the screw stop49urges a safety plate44of the lockout mechanism proximally against the bias of a spring42. This moves a tab47of safety plate44(FIG. 6A) out of engagement with the upper surface of the trigger lock50(as viewed in the orientation ofFIG. 6A) to permit pivoting of trigger lock50in the direction of arrow “B” inFIG. 2, thereby unblocking the firing trigger20and enabling firing of surgical stapling instrument10. This is described in detail in the aforementioned U.S. Pat. No. 7,303,106.

As shown inFIGS. 1-4B, approximation indicator mechanism100of the present disclosure includes a bulbous approximation indicator102, lens cover104(FIG. 4B) and slide member110. Indicator102is pivotally supported via pin109on projecting portion112of pivot member106which may be formed monolithically with handle assembly12. Lens cover104(or window of handle assembly12) is positioned above indicator102and may be formed of magnification material to facilitate easy visualization of indicator102. Slide member110is slidably positioned within handle assembly12. A biasing member, e.g., a coil spring120, is configured to urge slide member110distally within stationary handle18. In the unapproximated (spaced) and unfired position of instrument10(FIGS. 1 and 4B), biasing member120urges slide member110distally to maintain indicator102in a first position, which provides indication to a surgeon that the instrument10has not been approximated and is not in a fire-ready condition (seeFIGS. 1 and 4B). In an alternative embodiment, rather than the indicator attached to pivot member106by a pin, projecting portion112engages an inner surface of the indicator102to maintain the indicator in the first position.

During approximation of anvil assembly30and shell assembly31, a tab41of screw stop49passes through a slot of slide member110and engages a proximal end of the slot. Upon continued approximation of instrument10, screw40(a portion of which being in contact with the proximal end of slot) moves slide member110proximally within stationary handle18against the bias of spring120such that indicator102is rotated due to the pin attachment. Approximation indicator100pivots (or rotates) to a second position in the same manner as described in U.S. Pat. No. 7,303,106, the entire contents of which was incorporated hereinabove by reference. In an alternative embodiment where the indicator is not pinned, the projecting portion112of slide member110engages a portion of indicator102causing indicator102to pivot (or rotate) to a second position. In the second position, indicator102provides indication to a surgeon that the instrument has been approximated and is now in a fire-ready position ofFIG. 2.

Actuation of firing trigger20(i.e., pivoting in the direction of arrow “A” inFIG. 1) causes staples to be ejected from shell assembly31towards anvil assembly30. That is, firing trigger20is disposed in mechanical cooperation with a pusher (not explicitly shown in the illustrated embodiments), such that actuation of firing trigger20causes advancement of the pusher into contact with the staples to eject the staples into staple deforming pockets of anvil assembly130. More specifically, when firing trigger20is actuated, i.e. pivoted about pivot member29, firing link27(FIG. 4B) is moved proximally. Firing trigger20moves distally to advance a pusher link26distally against its spring bias. The distal end of pusher link26, attached to a pusher back (not shown), advances the pusher back to eject the annular rows of staples from the shell assembly31. Details of the firing mechanism are described in U.S. Pat. No. 7,303,106, incorporated by reference above.

Referring now toFIGS. 4B-6, a complete actuation of firing trigger20causes firing indicator200to pivot (or rotate) (e.g., against an initial bias) from its first position (FIGS. 4B and 4C) to its second position (FIGS. 3 and 5). Specifically, once firing trigger20is actuated an engagement structure of firing trigger20(e.g., a tab24thereon) contacts a portion of firing indicator200(e.g., a pawl210extending from firing indicator200and being monolithically formed therewith or operatively connected thereto). Firing indicator200is disposed in mechanical cooperation (e.g., pivotable or rotatable) with stationary handle18. The engagement between firing trigger20and firing indicator200(e.g., the engagement between tab24and pawl210shown inFIG. 5) causes pawl210of firing indicator200(e.g., pawl210) to rotate in the general direction of arrow “C” (FIG. 6). The indicator200rotates about a pivot point (e.g., a post within stationary handle18extending through an opening219(FIG. 6) of firing indicator200. The post is omitted inFIG. 6for clarity. In the illustrated embodiment, tab24includes an angled engagement surface24a(FIG. 4C) which is angled with respect to a longitudinal axis “A-A” defined by movable handle (firing trigger)20. Angled engagement surface24afacilitates the movement of pawl210of firing indicator200in a distal direction. Note in stapling devices applying annular rows of staples having two movable handles, tab24can be positioned on one of the handles.

FIG. 6illustrates firing indicator200in its first position with detents240, disposed on opposing sides of indicator200, positioned below ribs252(only one of which is shown) in the respective housing half. After firing indicator200is moved to its second position ofFIG. 3, firing indicator200is maintained in its second position by detents240engaging a respective recess250(only a single recess250is shown inFIG. 6for clarity since the other housing half has been removed) between ribs252,254in each of the body halves. After firing, the firing indicator200stays in the second position (i.e., with detents240between ribs252,254), until a user manually resets the firing indicator200to its first position by moving (rotating) a portion of firing indicator200(e.g., pawl210) proximally in the direction opposite arrow C to override the detent240/recess250engagement.

As firing indicator200rotates in the direction of arrow C to its second (completed firing) position, indicia220(FIG. 6; e.g., color, words, letters, bumps, etc.) thereon is moved from a first position towards a second position. In its second position (i.e., when firing indicator200is in its second position, as shown inFIG. 5), indicia220is visible to the user, e.g., through a window or opening230(FIG. 5) of stationary handle18. While not explicitly illustrated, it is contemplated that each side of handle assembly12includes a lens cover or window thereon. The lens could optionally be made of magnification material. In a preferred embodiment, firing indicator200includes a pair of indicia220thereon, one on each side, such that each indicia is visible through a corresponding window or opening230on each side of the instrument when firing indicator200is in its second position.

FIG. 4Cillustrates firing trigger20in an initial pre-fired position, where firing indicator200in is first position and where indicia220is in its first position not visible through window230.FIG. 5illustrates firing trigger20in a fired position, where firing indicator200is in its second position and wherein indicia220is visible through window230, thus providing an indication to a surgeon that the instrument has been fired.

Further details of other features of surgical instrument10, such as the approximation assembly, firing assembly, lock out mechanism and approximation indicator mechanism are disclosed in U.S. Pat. Nos. 7,168,604 and 7,303,106, the entire contents of each of which are incorporated by reference herein.

The present disclosure also relates to a method of performing a surgical procedure. The method includes providing a surgical instrument10including handle assembly12, elongated body portion14and head portion16. Handle assembly12includes a, firing trigger20and firing indicator200. Elongated body portion14extends distally from handle assembly12. Head portion16is disposed adjacent a distal portion of elongated body portion14and includes anvil assembly30and shell assembly31. The method also includes positioning surgical instrument10adjacent a surgical site and moving firing trigger20(preferably relative to stationary handle18) between a first non-actuated position and a second actuated position such that a portion of firing trigger20makes initial contact with a portion of firing indicator200(e.g., pawl210) when firing trigger20is moved to its second actuated position. Firing indicator200moves from a first position towards a second position upon contact between firing trigger20and firing indicator200.