CA2111896C - Surgical stapler with spent cartridge sensing and lockout means - Google Patents

Abstract

A stapler is disclosed that includes a mechanism for sensing whether the stapler is loaded with a fired cartridge housing and for preventing the stapler from being closed or fired when loaded with the fired cartridge. The mechanism also prevents the stapler from firing or clasping on tissue when the stapler is not loaded with a staple cartridge.

Description

--, 2~3.18~6 SURGICAL BTAPLER 11IT8 BPENT CARTRID(i8 BBNSIN(i AND
LOCKOUT lI811N8 This is a divisional of Canadian Patent Application Serial No. 2,068,581, filed May 13, 1992.
Technical Field The present invention relates generally to surgical stapling instruments and more particularly to the type of surgical stapling instruments used for applying linear parallel rows of staggered staples through compressed living tissue.
Bac Around Art Surgical stapling instruments used for applying parallel rows of staples through compressed living tissue are well known in the art, and are commonly used for closure of tissue or organs prior to transectfon, prior to resection, or in anastomoses, and for occlusion of organs fn thoracic and abdominal plasty procedures.
One known pneumo-intestinal surgical stapling instrument of this type has been in use for many years, and is currently available under the trade designation "The-PI Stapler", catalog # 3960 by Minnesota Mining and Manufacturing Company (3M); St. Paul, Minnesota, the use of which stapler is described in a publication entitled Surgical Stapling, Gastric and Small Bowel Procedures, Volume I", ISBN 0-937433-00-4, Library of Congress Catalog Number 85-082599 available from Xinnesota Kining and Manufacturing Company (3M), St. Paul, Minnesota.
That stapler and a sisilar stapler described in Freund et al. PCT l~pplication No. w0 83/02247, published July 7, 1983 are adapted !or Tiring staples into compressed living tissue lroa a staple lill~d cartridge or housing. The staplers have anvil and jaw portions, a cartridge holder including a removable cartridge and a handle lever.
"PI" type staplers have a handle lever, a generally C-shaped anvil portion having free and supported ends with an alignment aperture generally adjacent its Tree end, a cartridge transport member _ 2 _ adapted to releasably receive a cartridge or staple housing having an alignment through passage, and an alignment pin movable between an engaged or alignment position with the alignment pin extending through the through passage in the staple housing and into the alignment aperture in the anvil jaw and a release or disengaged position with the alignment pin spaced frog the alignment through passage and alignment aperture to afford removal and replacement of a spent staple cartridge.
The anvil and cartridge transport members are each elongate in a longitudinal direction, and the anvil portion has specially shaped anvil surfaces situated in a plane generally perpendicular to the longitudinal direction. When the alignment pin extends through the through passage in the staple housing and into the alignment aperture in the anvil jaw (i.e, when the alignment pin is in the alignment position), the specially shaped anvil surfaces are positioned generally opposite longitudinal slots in the cartridge or staple housing which contain unfired staples. The cartridge transport member/cartridge housing is movable between a --closed or clamping position with the cartridge housing and the anvil surfaces in closely spaced relationship, and an open position with the cartridge housing and the anvil surfaces spaced farther from each other than in the closed position.
Typically, a "PI" type stapler is positioned adjacent the tissue to be stapled, the anvil and jaw portions era approximated adjacent the tissue to be stapled, the alignment pin is moved to the alignment position, and the stapler is clamped on the tissue by moving the handle lever in a first movement to cause the cartridge holder to sova toward the anvil placing the cartridge housing in a closed "clamping" position where the staples say ba fired. Roving the handle lever in a second aowment "lines" the stapler (e.g. it ejects the staples from the cartridge).
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In some surgical procedures the clamping force results in tissue that is highly compressed to ensure, inter alia, proper hemostasis in the tissues being stapled. The clamping force is present in various degrees in each of the surgical procedures for a "PI"
type surgical stapler. Such a clamping force causes tissue trauma in the tissue to be stapled, at least to some degree.
Under a great clamping force, a prior art "PI"
type stapler without an engaged alignment pin typically "scissors" or fails by deflection of the anvil portion and the cartridge housing laterally relative to one another (e. g. where the anvil portion deflects laterally with respect to the longitudinal axis of the stapler and/or where the cartridge housing deflects in a lateral direction opposite the deflection direction of the anvil portion).
Moving the alignment pin to the alignment position before firing the stapler or before clamping tissue between the anvil and cartridge housing affords a more precisely controlled formation of the fired staples by aligning the specially shaped surfaces on the anvil portions with the staples in the cartridge housing and by preventing the cartridge housing and the specially shaped anvil surfaces from "scissoring". Hoving the aliqnmant pin to the alignment position also prevents tissue from escaping from between the anvil and cartridge housing when the cartridge assembly is clamped on the tissue to be stapled.
The prior art "PI" type staplers encounter problems because it is possible to fire the stapler or clamp tissue between the anvil and cartridge housing without the alignment pin in the alignment position. It is believed that it is difficult to determine whsthar the alignment pins o! the prior art "PI" type staplers era engaged, particularly in the surgical environment. 711so, it is possible to inadvertently fail to cove the alignment pin to the alignment position. If the alignment pin is not aovad to the alignment position ---. ~~~~~~~
-before clamping tissue between the anvil and cartridge housing, tissue intended to be stapled may escape from between the anvil and cartridge housing resulting in incomplete anastomoses and other undesirable results.
7~dditionally, if the alignment pin is not moved to the alignment position before the stapler is fired, the staples may be improperly formed. The prior art "PI" type staplers also encounter problems because it is difficult to determine when they are loaded with a "spent" cartridge or with a cartridge that does not contain staples. On occasion, a spent cartridge may ba inadvertently left in a stapler after it has been fired during a surgical procedure where the stapler is used several times for the same patient, or a spent cartridge may be inadvertently loaded into a stapler that is about to be fired in the patient. If a stapler is loaded with a cartridge housing other than a ready-to-fire cartridge housing and the stapler is clamped on tissue to be stapled, the compressive forces created by the stapler subject the tissue to undesirable and unnecessary trauma.
The sequence of (1) clamping the stapler with a spent cartridge on tissue, (2) firing the ~dud" stapler (3) subsequently rearming, (~) again approximating the stapler adjacent the tissue to be stapled and (5) reclamping the stapler wastes precious time during the surgical procedure.
Additionally, the prior art "PI" type staplers may ba used in procedures in which the surgeon uses a scalpel to manually create an incision on a side of closed staples (e.g, the procedure described in the article entitled "Resection o! the Lesion" on pages 14 and 15 of the publication entitled Surgical Stapling, Gastric and Small Bowel Procedures, Volume i", ISHN y ~ .
0-937433-00-4, Library o! Congress Catalog !lumber 85-082599 available from Minnesota Mining and Manufacturing Company (3M), St. Paul, Kinnesota). 71 spent stapler cartridge used in such procedures may result in unnecessary blood loss, inadequate hamostasis ~

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and tissue trauma for the patient undergoing the procedure.
Surgical stapler cartridge safety devices are described in U.S. Patents No. 4,863,088 and 4,955,959, and U.S. Patent Application 07/629,597. The firing mechanisms in those staplers sequentially close staples into tissue. Since each staple is closed within tissue one alter another in succession, the force required to fire such staplers is generally lass than the force required to lire a "PI" type stapler where all the staples are generally closed in tissue at the same time.
Unlike the present invention wherein the same part (e.g. a lever or "handle") is operable in both a lust movement to approximate and clamp tissue and a second movement to close all the staples within tissue generally simultaneously, the "ILA" type staplers described in U.S. Patents No. 4,863,088 and 4,955,959, and U.S. Patent Application 07/629,597 utilize separate and distinct member to (1) sequentially fire the staples (e.g, a firing tab or button) and (2) clamp onto the tissue (an element of the stapler that does not include the firing tab or button).
U.S. Patent No._4,527,724 to Chow et al. and assigned to Seamed, Inc., of Cincinnati, Ohio disclose a surgical stapler similar to the surgical stapler sold by Ethicon, Inc., of Somarville, N.J. under the trade name "Proximate". That stapler includes a lockout device which precludes rotation o! an adjustment knob to clamp the stapler on tissue unless the alignment and retaining pin is shilted to its operative position. The lockout device, however, is only operative until the user slides the alignment and retaining pin to the operative position. Once the user slides the alignaent and retaining pin to the operative position, the lockout 95 device is not designed to be easily reactivated. Thus, to defeat the lockout device, s user need only slide the pin to the operative position and then sway frog the operative position. The stapler has no feature which ~
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retains the pin in the operative position when the stapler is clamped on tissue.
Disclosure of the Invention ~
The present invention provides a surgical stapler comprising an anvil frame elongate in a longitudinal direction and including anvil surfaces in a plane generally perpendicular to the longitud:~al direction, surfaces delining an alignment aperture ~
opening onto the anvil surfaces, and a cartridge assembly movable relative to the anvil frame between an open position with the cartridge assembly spaced from the anvil surfaces and a closed position with the cartridge assembly and the anvil surfaces in closely spaced relationship. The cartridge assembly comprises a cartridge housing containing a plurality of staples disposed in rows positioned in opposition to the anvil surfaces.
The surgical stapler also includes a longitudinally extending alignment pin mounted on the stapler for movement between an alignment position with the alignment pin extending into the alignment aperture, ~
and a release position with-the alignment pin spaced from the alignment aperture.
8y including a mechanism for engaging the cartridge assembly and anvil for continuously preventing the cartridge assembly from moving from the open to the w .
closed position whenever the alignment pin is in a position other than the alignment position, and for preventing the alignment pin from moving from the alignment position toward the release position when the cartridge assembly is in the closed position, the present invention provide a stapler which (1) contributes to the proper formation o! staples, (2) promotes proper ~S hemostasis in the tissue to be stapled, (3) prevents , "scissoring" o! the anvil and cartridge portions o! the stapler, (4) prevents tissue from ucaping froa between the anvil and cartridge housing when the cartridge assembly is clamped on the tissue to be stapled, and (5) v \ ~~~ i y~.", ~';' ~! t ~ 4y . -, i a7 . , .. .
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_,_ reduces the likelihood of a weak joint or an absence of blood flow in the joint and tissue.
The stapler according to the invention includes a mechanism for firing the stapler by engaging and closing the staples in tissue between the cartridge housing and the anvil surfaces, and a means preventing the cartridge assembly from moving from the open to the closed position unless the stapler is loaded with a ready-to-fire cartridge housing. The means for preventing the cartridge assembly lrom moving from the open to the closed position (1) prevents approximation and clamping of living tissue between anvil and cartridge components of the stapler when the stapler is loaded with a spent stapler cartridge, (2) prevents the user from attempting to refire the stapler, and (3) provides a stapler that reduces the chances of unnecessary tissue trauma, blood loss, inadequate hemostasis, and squandered time during surgery.
llccording to a preferred embodiment o! the stapler of the present invention, there is provided a stapling instrument comprising an anvil frame having proximal and distal ends and a pair of lateral side portions that are each elongate in a longitudinal direction and spaced to define a channel therebetween.
The anvil frame has a handle portion generally adjacent the proximal end with first and second ends, and a jaw portion having anvil surfaces generally adjacent the distal end. The jaw portion includes surfaces defining an alignment aperture opening onto the anvil surfaces, 3o and the anvil surfaces are positioned in a plane generally perpendicular to the longitudinal direction.
An elongate aanually movable handle or lever part having first and second ends is pivotally mounted at its second end to alford pivotal movement o! the lever part relative to the anvil frame between a release position with the first end of the lever part bsing spaced from the lirst end o! the handle portion and an actuation position with the lever part and the handle portion in closely spaced relationship. 71 biasing means S

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7~ cartridge assembly having proximal and distal ends is mounted in the channel between the lateral aide portions for longitudinal movement relative to the anvil frame. The cartridge assembly comprises a cartridge transporting member having first and second side portions that are each elongate in the longitudinal direction and that are spaced to define a ram channel therebetween.
The first and second side portions have surfaces def fining a cartridge groove generally adjacent the distal end of the cartridge assembly.
The cartridge groove surfaces are adapted to releasably receive a cartridge housing containing a plurality of staples disposed in rows positioned in opposition to the anvil surfaces, and pusher means, such as a pusher, for pressing the staples within the cartridge housing against the anvil surfaces to engage and close the staples in tissue between the cartridge housing and the anvil surfaces. The pusher has a pair o!
edges and is positioned proximate the staples for movement between pre-fired and fired positions with the pusher adapted to cove distally relative to the cartridge housing when the stapler is tired. The cartridge housing also includes surfaces defining an alignment through .
passage positioned in opposition to the alignment aperture and whose function will be described later.
a means counts the cartridge assembly !or longitudinal movement relative to the anvil frame between a closed position with the cartridge housing and the anvil surfaces in closely spaced relationship, and an open position with the cartridge housing and the anvil surfaces spaced farther from each other than in the closed position.
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-. 9 -An elongate T-bar or "ram" is mounted in the ram channel between the first and second side portions for longitudinal movement relative to the cartridge transporting member and the anvil frame. The ram is adapted to engage and drive the pusher distally to fire the stapler when the cartridge housing the anvil surlacas are in the closed position.
1~n actuation moans is present to initially move the cartridge assembly from the open to the closed position by a first movement of the lever part from the ' release to the actuation position and for subsequently firing the stapler (i.e, moving the ram distally relative to the cartridge transporting member to cause the pusher to eject the staples from the cartridge housing, to press the staples against the anvil surfaces and to engage and close the staples in tissues between the cartridge housing and the anvil jaw portion) by a second movement of the lever part from the release to the actuation position. Another biasing means (such as a coil spring connected between the anvil frame and the ram) biases the cartridge assembly from the closed to the open position, That biasing means preferably comprises a coil spring connected between the anvir frame and the ram.
The actuation aeons preferably comprises a toggle joint linkage having an over center pivoting portion and first and second ends with the first end fixed to the anvil frame and with the second and connected to the cartridge transporting member. Tha over canter pivoting portion pralarably has surfaces adapted to engage the lever part when the lever part is first moved from the release to the actuation position to nova the toggle joint liNcag~ lrom a retracted position past an in-line or centered position with the toggle joint linkage generally straight, to a slightly inverted (relative to the ratract~d position) extended position to drive the cartridge assembly from the open to the closed positions. The actuation means also preferably include means for retaining the cartridge assembly in the closed position against the bias o! the coil spring that biases ; , h ..~ :v.,:~, . ..; ., ~..
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the cartridge assembly from the closed to the open position. Preferably, such a means comprises a stop flange on the over center pivoting portion o! the toggle joint linkage that prevents the toggle joint linkage from moving past the extended position. J~lternatively such a means may comprise a stop surface located on a handle cover.
The actuation means also preferably includes surfaces defining a cam shoulder surface on the ram, and a pawl having lirst and second ends and a cam surface generally adjacent the second end of the pawl, and aeans mounting the pawl on the lever part for movement between a first position with the cam surface generally spaced from the cam shoulder surface on the ram and a second position with the cam surface engaged with the cam shoulder surface on the ram to afford firing of the stapler by driving the ram distally relative to the cartridge transporting member. ~rlso preferably, the stapler further includes means, such as a torsion spring, !or biasing the pawl toward the second position, and the ran has surfaces which are adapted to retain the pawl in the first position until the cartridge assembly is moved from the open to the closed position. ...
J~dditionally, the stapler preferably further includes a release arm having a first end pivotally mounted to the proximal end of the anvil frame and a second engagement end. The release arm has surfaces adapted to engage the pawl and the toggle joint linkage "":,, to cove the pawl frog the second to the first position 30. and to cove the toggle joint linkage from the extended toward the retracted position to afford movement o! the cartridge asseably from the closed to the open position under the bias of the means !or biasing the cartridge assembly from the closed to the open position (e.g, the coil spring).
The stapler according to the present invention also includes a means for sensing whether the stapler is loaded with a fired cartridge housing and for preventing 2~~.18~6 the stapler from being closed or fired when loaded with the fired cartridge.
In a first embodiment of a stapler according to the present invention, the means for preventing the cartridge assembly from moving from the open to the closed position when the stapler is loaded with a spent cartridge housing comprises the anvil frame having surfaces defining a safety aperture opening into the surface o! the anvil frame and having a bottom surface, 1o and a locking pin having first and second ends. The locking pin is mounted within the safety aperture for movement between a free travel position with the first and of the locking pin abutting an edge of the pusher to afford a single, reciprocating aovement of the cartridge assembly between the open and closed positions, and a blocking position with the first end of the locking pin projecting beyond the safety aperture and into the path of the ram to prevent subsequent aovement of the cartridge assembly from the open to the closed position.
A biasing means biases the locking pin toward the blocking position. That biasing aeana preferably comprises a coil spring having a first end connected to the second and of the locking pin and a second end connected to the bottom surface of the safety aperture.
Zn a second embodiment of stapler according to the present invention, the stapler includes a different scans for preventing the cartridge assembly frog aoving from the open to the closed position when the stapler is loaded with a cartridge housing with the pusher in a fired position comprising a locking notch in the cartridge transport aeaber of the cartridge assembly such that the locking pin engages with the surfaces of the locking notch to prevent aoveaent of the cartridge assembly lrom the open to the closed position when the locking pin is in the blocking position. =n the second embodiment, the locking pin engages the locking notch to prevent movement of the cartridge assembly rather than simply acting as an obstacle to the ram.
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_ 12 _ In a third embodiment of stapler according to the present invention, the locking notch and/or the locking pin have sloped or tamped caroming surlaces to cam the locking pin toward the free travel position when the cartridge assembly initially moves from the open to the closed position.
The three embodiments mentioned above may also include a safety guide member. The safety guide member comprises (1) a sleeve slidably counted on the anvil frame for longitudinal movement relative thereto and having proximal and distal ends, (2j a longitudinally extending alignment pin mounted on the distal end of the sleeve for movement between an alignment position with the pin passing through the cartridge housing alignment y through passage and extending into the alignment aperture and a release position with the alignment pin spaced lrom .
the alignment through passage and the alignment aperture, and (3) means for preventing the cartridge assembly from w moving from the open to the closed positions unless the alignment pin is in the alignment position, -and for preventing the alignment pin from moving from the alignment position toward the release position when the cartridge assembly is in the closed position.
The means for preventing the cartridge assembly from moving from the open to the closed positions unless the alignment pin is in the alignment position, and for preventing the alignment pin from moving from the alignment position toward the release position when the cartridge assembly is in the closed position preferably comprises surfaces defining a safety notch in the anvil !tame, cartridge transport member and ram, and a salety gate having cam shoulder surfaces and surfaces dalining w hole. The surfaces defining a safety notch in the anvil frame, cartridge transport aember and ray are aligned when the cartridge assembly is in !ha open position to define a continuous salety notch extending laterally across the stapler and era staggered when the cartridge assembly is in the closed position.

?~1~8~6 The safety gate is mounted adjacent the anvil frame for relative movement thereto between a latched position with the safety gate engaged with the surfaces defining the continuous safety notch to prevent relative movement between the cartridge assembly and the anvil frame, and an unlatched position with the safety gate spaced from the safety notches to afford relative movement of the cartridge assembly and the anvil frame between the open and closed positions.
The safety guide member includes safety gate deactivating guides projecting proximally lrom the proximal end of the sleeve and through the safety gate hole. The guides are adapted to bias the safety gate toward the latched position when the alignment pin is in a position other than the alignment position and have cam surfaces at a proximal end adapted to engage the cam shoulder surfaces of the safety gate to drive the safety gate from the latched to the unlatched position when the alignment pin is moved to the alignment position.
The means for preventing the alignment pin from moving From the alignment position toward the release position when the cartridge assembly is in the closed position includes the safety gate deactivating guides having return cam aurfacas generally opposite the cam surfaces adapted to engage surfaces on the safety gate to drive the safety gate from the unlatched toward the latched position when the alignment pin is aovad away from the alignment position, and surfaces on the cartridge transport aeabar and ram adapted to engage the 3o salety gate to prevent the return cam surfaces lrom driving the safety gate from the unlatched position toward the latched position to thereby prevent the ~
alignment pin from moving lrom the alignment position toward !he release position when the cartridge assembly is in tha closed position.
br3a! Description of the Drawing The present invention will be further described with reference to the accompanying drawing wherein like : , , ;.
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- 14 - . w reference numerals refer to like parts in the several views, and wherein:
Figure 1 is a perspective view of the surgical stapling instrument according to the present invention;
Figures 2 through 5 are enlarged first side views of the surgical instrument of Figure 1 which sequentially illustrate the operation of the stapler wherein:
Figure 2 shows the relative positions of the anvil !rams and the cartridge assembly in an open position and has portions broken away to show details; ", Figure 3 illustrates the positions of the anvil frame and the cartridge assembly just after the cartridge assembly fs moved to the closed position and has portions broken away to show details;
Figure 4 shows the positions of the anvil frame and the cartridge assembly just before the stapler is fired and has portions broken away to show details;
Figure 5 illustrates the stapler just after the stapler is fired;
Figure 6 is an enlarged bottom view of the surgical instrument of Figure 1 which has portions broken away to show details;
Figure 7 is an enlarged sectional view o! the staples of Figure 1 taken approximately along line 7-7 0!
Figure 5;
Figure 8 is an enlarged sectional view of the stapler o! Figure 1 taken approximately along lira 8-8 0!
Figure 2 and having portions broken away to show details;
Figure 9 is an enlarged second side view o! the stapler o! Figure 1 having portions broken away to show details o! an actuation mechanism;
Figure io is an enlarged second side view o!
the stapler o! Figure 1 having portions broken away to show details o! an actuation mechanism and which illustrates the proximal and o! the stapler;
Figure li is an enlarged first side view o! the stapler o! Figure 1 having portions broken away to show details of an actuation mechanism;

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Figure 12 is an enlarged first side view of the distal end of the stapler of Figure 1 illustrating a pusher in a pre-fired position;
Figure 13 is an enlarged first side view of the distal end of the stapler of Figure 1 illustrating a pusher in a fired position;
Figure 14 is an enlarged sectional view of the stapler o! Figure 13 taken approximately along lima i4-14 o! Figure 13 and having portions broken away to show l0 details;
Figure 15 is an enlarged first side view of a distal and of a second embodiment of surgical stapler according to the present invention whose proximal end is generally identical to the proximal end of the stapler o!
Figure i, and which illustrates a pusher in a pre-tired position;
Figure 16 is an enlarged first side view of the ~
distal end of the stapler of Figure 15 illustrating a pusher in a fired position;
Figure 17 is an enlarged sectional view of the stapler of Figure 15 taken approximately along line 17-17 of Figure 16 and having portions broken away to show , details; --Figure 18 is an enlarged perspective view of the stapler of Figure 1 having portions broken away to show detail and showing a safety gate in a latched position;
Figure 19 is a sectional view of the stapler o!
Figure 1 taken approxiaately along line 19-19 of Figure "
9;
Figure 20 is an enlarged first side view o! a distal end of a third embodiment of surgical stapler .
according to the present invention whose proximal and is generally identical to the proximal end of the stapler of Figure 1, with portions broken away to shown details o!
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- 16 - , Figure 21 is an enlarged first side view of the distal end of the stapler of Figure 20 illustrating a pusher in a farad position.
Detailed Description Referring now to Figures 1 through 14 of the drawing, there is shown a first embodiment of surgical stapling instrument according to the present invention, generally designated by the reference numeral 10.
Generally the surgical stapling instrument 10 comprises an anvil frame 12 having proximal 14 and distal 16 ends and a pair of lateral side portions 17 and 18 ' that era each elongate in a longitudinal direction and spaced to define a channel therabatween. The anvil frame 12 has a handle portion 19 generally adjacent the proximal end 14 with first 20 and second 21 ends, and a jaw portion 22 having anvil surfaces 23 generally adjacent the distal end 16. The anvil surfaces 23 are specially shaped and are positioned in a plane generally perpendicular to the longitudinal direction. The jaw portion 22 includes surfaces defining an alignment aperture 15 opening onto the anvil surfaces 23, the function of which will be described later.
a handle housing 24 is attached to the anvil frame 12 and may be constructed frog any suitable material such as but not limited to a polymeric material such as nylon, polypropylene, high density polyethylene, acrylonitrile butadiene styrene (lirBS), polyatherimide, polystyrene, acetal or polycarbonate. 11n elongate manually movable handle or lever part Z5 (sae Figure 9) having first 26 and second 27 ends is pivotally mounted at its second end 27 to the anvil frame 12 by means such as a pin 28. 11 handle cover 29 is attached to the lever part 25 and may be constructed from any suitable material such as but not limited to a polymeric material similar to the material used to construct the handle housing 24.
The handle cover 29 and the handle housing Z4 era shaped to afford convenient, efficient manual grasping of the A.
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stapler 10 and may be snap fit to the stapler 10 (e. g.
the lever part 25 and anvil frame 12 respectively).
The lever part 25 is connected to the anvil w frame 12 at a position generally adjacent the second end 21 of the handle portion 19. The pin 28 mounts the handle part 25 and handle cover 29 to the anvil frame 12 to afford pivotal movement of the lever part 25 relative to the anvil frame 12 between a release position (Figures l, 2 and 4) with the first and 26 of the lever part 25 spaced from the first end 14 0! the handle portion 19 and an actuation position (Figures 3 and 5) with the lever part 25 and the handle portion 19 in closely spaced relationship. A biasing means biases the lever part 25 toward the release position. Preferably, the biasing means comprises an extension coil spring 30 mounted at one end to the anvil frame 12 and at the other end to the lever part 25.
~r cartridge assembly 32 having proximal 33 and distal 34 ends is aounted in the channel between the lateral side portions 17 and 18 for longitudinal movement relative to the anvil frame 12. The cartridge assembly 32 comprises a cartridge transporting member 35 having first 36 and second 37 'side portions that are each elongate in the longitudinal direction and that are spaced to define a ram channel therebetween. The first and second side portions 36 and 37 have surfaces defining a cartridge groove 38 generally adjacent the distal end 34 of the cartridge assembly 32. Tha cartridge groove surfaces 38 era adapted to ralaasably receive a cartridge housing 40.
Tha cartridge housing 40 includes a plurality o! ataplu 41 disposed in rows oriented in planas generally perpendicular to the longitudinal direction and positioned in opposition to the anvil surfaces 23, and manually activatable aeans, such as a pusher 42, !or prauinq the staple 41 within longitudinal slots 46 in the cartridge housing 40 against specially shaped anvil surfaces 23 to engage and close the staples 41 in tissue between the cartridge housing 40 and the anvil surfaces 2~1~.~~6 - 18 - . .
23. The pusher 42 has a pair of edges 43 and is positioned proximate the staples 41 for movement between pre-fired (Figure 12) and fired (Figure 13) positions with the pusher 42 adapted to move distally relative to the cartridge housing 40 when the stapler 10 is fired.
The cartridge housing 40 also has surfaces defining a close fitting hole or alignment through passage 58 positioned in opposition to the alignment aperture 15 in the anvil !tame 12. The alignment through passage 58 and the alignment aperture 15 may be generally cylindrical and coaxial and perform a function to be described later.
11 means such as pins 44 and grooves 45 mounts the cartridge assembly 32 for longitudinal movement relative to the anvil frame 12 between a closed position (Figures 3, 4 and 5) with the cartridge housing 40 and the anvil surfaces 23 in closely spaced relationship, and an open position (Figures 1 and 2) with the cartridge housing 40 and the anvil surfaces 23 spaced farther from each other than in the closed position.
An elongate T-bar or ram 48 is mounted in the ram channel between the first and second side portions 36 and 37 of the cartridge transport member 35 for longitudinal movement relative to the cartridge transporting member 35 and the anvil frame 12. The T-bar or ram 48 is adapted to engage the pusher 42 to drive the pusher 42 distally to eject the staples 41 from the cartridge housing 40, to press the staples 41 against the specially shaped anvil surfaces 23 and to engage and close the staples 11 in tissues between the cartridge housing 40 and the anvil jaw portion 22 when the cartridge housing 40 and the anvil surfaces 23 are in the closes position.
Figures 2 through 5 sequentially illustrate the operation o! the stapler 10. 11n actuation means 50 ' operable in a lirst aovemant of the lever part 25 from the release to the actuation position initially mows the cartridge assembly 32 from the open to the closed position (Figure 2 and 3) . Tha actuation means 50 is 21~~t~~ o operable in a second movement (Figures 4 and 5) of the lever part 25 from the release to the actuation position to subsequently fire the stapler 10 (e. g, the actuation means 50 drives the ram 48 distally relative to the cartridge transporting member 35 to engage and move the pusher 42 distally to eject the staples 41 from the cartridge housing 40, to press the staples 41 against the anvil surfaces 23 and to engage and close the staples 41 in tissues between the cartridge housing 40 and the anvil jaw portion 22). 1~ means such as a coil spring 51 connected between the anvil frame 12 and the ram 48 bias the cartridge assembly 32 trom the closed to the open poaition and is temporarily overcome by the actuation .
means 50.
The actuation means 50 preferably comprises a toggle joint linkage 52 having an over center pivoting portion 53 and first 54 and second 55 ends with the first end 54 pivotally mounted to the anvil frame 12 by pin 56 and with the second end 55 pivotally connected to the cartridge transporting member 35 by a pin 57. The over center pivoting portion 53 preferably has surfaces adapted to engage cooperable surfaces on the lever part when the lever part 25 is first moved from the release to the actuation position to move the toggle joint 25 linkage 52 from a retracted position (see Figures 1 and 2 with the cartridge assembly 32 in the open position) past an in-line or centered position with the toggle joint linkage generally straight, to an extended position (Figures 3, 4, 5 and 10) with the toggle joint linkage 52 being slightly bent in a direction inverted relative to the retracted position. Movement of the toggle joint linkage 52 from the retracted to the sxtended position drives the cartridge assembly 32 lrom the open to the v closed positions.
The actuation means also preferably includes means for retaining the cartridge assembly 32 in the closed position against the bias of the coil spring 51 for biasing the cartridge assembly 32 from the cloud to the open position. Prelerably, such a means comprises a 21~.~8~6 stop flange 66 on the over center pivoting portion 53 0!
the toggle joint linkage 52. The stop flange 66 is w adapted to engage surfaces on the toggle joint linkage 52 to prevent the toggle joint linkage 52 from moving past the extended position. Alternatively such a means may comprise a stop surface located on the handle housing 24.
Also, a relatively weak torsion spring (not shown) may be mounted on the over canter pivoting portion 53 0! the toggle joint linkage 52 to bias the toggle joint linkage 52 toward the extended position and to prevent the cartridge assembly from accidentally opening when the handle lever 15 is moved from the actuation to the release position just alter firing the stapler 10.
The actuation means 50 preferably includes surfaces defining a cam shoulder surface 49 on the ram 48, and a pawl 60 having first 61 and second 62 ends and a cam surface 63 generally adjacent the second and 62.
A means such as pin 64 mounts the pawl 60 on the lever part 25 for movement between a first position (Figures 2, 3 and 9) with the cam surface 63 spaced from the cam shoulder surface 49 on the ram 48 and a second position (Figures 4, 10 and ii) with the cam surface 63 engaged with the cam shoulder surface 49 on the ram 48 to afford firing of the stapler 10 by driving the ram 48 distally relative to the cartridge transporting member 35 when the cartridge assembly 32 is in the closed position. Also preferably, the stapler 10 further includes means for biasing the pawl toward the second position such as torsion spring 65, and the ram 48 has sliding surfaces 47 adapted to retain the pawl 6o in the first position until the cartridge assembly 32 is moved from the open to the closed position.
Additionally, the stapler 1o includes a release era 70 having a first end pivotally mounted to the proximal end 14 0! the anvil frame 12 by pin 56 and a second end connected to manually activatable release button 72 extending laterally from the handle housing =4.
The release arm 70 has surfaces 73 adapted to engage shoulder portions or "pin" 67 of the pawl 60 and , _ 2~.~.1~~~

laterally inwardly projecting surfaces (not shown) adapted to engage the over center portion 53 of the toggle joint linkage 52 to initially move the pawl s0 from the second toward the f first position and to then move the toggle joint linkage 52 from the extended toward the retracted position to afford movement of the cartridge assembly 32 from the closed to the open position under the bias of spring 51.
The function o! the alignment through passage 58 and the alignment aperture 15 will now be described relative to the function of a safety guide member 88 comprising a sleeve 89 having proximal and distal ends.
Tha sleeve 89 is slidably mounted on the anvil frame 12 for longitudinal movement relative thereto. ~
longitudinally extending alignment or retention pin 90 is mounted on the distal end of the sleeve 89 for movement between an alignment position (Figures 3, ~ and 5) with the alignment pin 90 passing through the cartridge housing alignment through passage 58 and extending into the alignment aperture 15 to position the rows of staples ~
41 relative to the specially shaped surfaces 23 on the anvil frame 12 to afford_a more precisely controlled ~
formation of fired staples and to prevent tissue from escaping from between the cartridge housing 40 and the anvil surfaces 23 when the cartridge assembly 32 is moved to the closed position, and a release position (Figures .;
1 and 2) with the alignment pin 90 spaced from the alignment through passage 58 and the alignment aperture 15 to afford removal and rsplacament of the cartridge housing with s new cartridge housing, w In the slignmant position, the alignment pin 90 is adapted to position the rows of staples 41 r~lativa to the specially shaped surfaces 23 on the anvil frame 12 to afford a more pr~cis~ly controlled formation of fired staples and to prevent tissue from escaping from between the cartridge housing 10 and the anvil aurfacas 23 when the cartridge assembly 3Z is moved to the closed position.
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There may also be present means 94 !or preventing the cartridge assembly 32 from waving from the open to the closed_position unless the alignment pin 90 is in the alignment position, and for preventing the alignment pin 90 from moving from the alignment position toward the release position when the cartridge assembly 32 is in the closed position comprising surfaces defining a safety notch 92 in the cartridge assembly 32 (including both the ram 48 and the cartridge transport member 35) and the anvil frame 12.
The surfaces defining a safety notch 92 in the anvil frame i2, cartridge transport member 35 and ram 48 era aligned when the cartridge assembly 32 is in the open position to define a continuous safety notch (Figures 2, 9, 18 and 19) extending laterally across the stapler 10 and are staggered (see Figures 3, 4 and 10) when the cartridge assembly 32 is in the closed position.
The means 94 includes a safety gate 95 (Figures 18 and 19) having cam shoulder surfaces 85 and return cam surfaces 8 generally opposite the cam surfaces 85. The safety gate 95 includes surfaces defining a safety Bats hole 87. The safety gate 95 is mounted adjacent the anvil frame 12 for relativc movement thereto between a latched position (Figure 2) with the safety gate 95 engaged with the surfaces defining the continuous safety notch 92 to prevent relative movement between the cartridge assembly 32 and the anvil frame 12 when the cartridge assembly 32 is in the open position, and an unlatched position (Figures 3, 4 and 9) with the safety gate 95 spaced lrOD the satsty notch 92 to a!lord relative longitudinal movement of the cartridge assembly 32 and the anvil !rams 12 between the open and closed positions. The handle housing 24 includes guide surfaces defining a slot 77 that a!lords reciprocating soveasnt o!
the safety gate 95 between the latched and unlatched positions.
As part o! the means 94, the safety guide aember 88 includes safety gate deactivating guides 98 projecting proximally troy the proximal end o! the sleeve a. a t a i aa' .l a \ '[~< a., '~\ Tlaaa a . 1 ; ' ~1 'f V
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2~.1~p~ o 89 and through the safety gate hole 8i. Return cam surfaces 8 of the guides 98 bias the safety gate 95 toward the latched position when the alignment pin 90 is in a position other than the alignment position. The cam surfaces 99 at a proximal end of the guides 98 are adapted to engage the cam shoulder surfaces 85 of the safety gate 95 to drive the safety gate 95 from the latched to the unlatched position when the alignment pin 90 is moved to the alignment position. Surfaces 7 l0 (Figure 18) on the cartridge transport aembsr 35 and ram 48 era adapted to engage the "top" of the safety gate 95 to prevent the return cam surfaces 8 from driving the safety gate 95 from the unlatched position toward the latched position when the cartridge assembly is in the closed position. Thus, once the alignment pin 90 is moved to the aligned position, the means 94 also prevents the alignment pin 90 from moving from the alignment position toward the release position when the cartridge assembly 32 is in the closed position.
The stapler 10 according to the present invention also includes a means preventing the cartridge ..
assembly from moving from th_e open to the closed position unless the stapler 10 is_ loaded with a ready-to-lire staple cartridge.
~s best seen in Figures 12 though 14, a first embodiment of a stapler 10 according to the present invention may comprise a means for preventing the cartridge assembly 32 from aoving from the open to the closed position when the stapler 10 is loaded with a cartridge housing 4o having a pusher 42 in a lirad position. Such a means prevents approximation and clamping of living tissue between anvil (a.g. 23) and cartridge (e.g. 40) components of the stapler 10 when the stapler 10 is loaded with a spent stapler cartridge, and .
prevents firing o! the stapler 10 when the stapler is loaded with a spent stapler cartridge. Figures 12 through 14 illustrate a stapler to wherein the means !or preventing the cartridge assembly 32 from moving lrom the open to the closed position comprises the anvil frame 12 ;.,, ~" -", , . ,, .,.~..~.:.: ' ' k ' ,: r""... :.:: ,. :-'. ; ~
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21~~.8~6 having surfaces defining a safety aperture 81 opening , into the surface of the anvil frame 12 and having a bottom surface, and a locking plate or pin 82 having first 83 and second 84 ends. The lacking pin 82 is mounted within the safety aperture 81 !or movement between a free travel position (Figure 12) with the first end 83 of the locking pin 82 generally abutting an edge 43 of the pusher 42 to afford a single, reciprocating movement of the cartridge assembly 32 between the open and closed positions, and a blocking position (Figure 13) with the lirst end 83 of the locking pin 82 projecting beyond the safety aperture 81 and into the path of the ram 48 to prevent movement of the cartridge assembly 32 from the open to the closed position. a biasing means biases the locking pin 82 toward the blocking position.
That biasing means preferably comprises a coil spring 86 having a first end connected to the second end 84 of the locking pin 82 and a second end connected to the bottom surface of the safety aperture 81.
OPERATION
The operation of the present invention may now be described with reference to the stapler 10. Figures 2 through 5 sequentially illustrate the operation of the stapler 10.
Figure 2 illustrates the relative positions of the anvil frame 12 and the cartridge assembly 32 in an open position. Typically the stapler l0 may be .
positioned adjacent the tissue to be stapled, and the alignment pin 90 is then moved trom the release position (Figure 2) to the alignment position (Figures 3, 4 and 5) by moving the sleeve 89 distally. When the alignment pin 90 is located in the alignment position, the cam surfaces 99 move the safety Bata 95 to the unlatched position to afford relative movement between the cartridge assembly 32 and the anvil !tame 12.
Zn the alignment position, the alignment pin 90 passes through the cartridge housing alignment through passage 58 and extends into the alignment aperture 15 to ,~ 's Z

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_ 25 _ orient and position the rows of staples 41 relative to the specially shaped surfaces 23 on the anvil frame 12 to afford a more precisely controlled formation of fired staples. Placing the alignment pin 90 in the alignment position also prevents tissue from escaping lrom between the cartridge housing 40 and the anvil surfaces 23 when the cartridge assembly 32 is moved to the closed position.
Figure 3 illustrates the positions of the anvil !tame 12 and the cartridge assembly 32 just after the cartridge assembly 32 is moved to the closed position by a first movement of the lever part 25 from the release position to the actuation position, after which the coil spring 30 returns the lever part 25 to the release position shown in Figure 4, when the cartridge assembly is in the closed position, the surfaces 7 (Figure 18) on w the cartridge transport member 35 and ram 48 are adapted .
to engage the "top" of the safety gate 95 and prevent the return cam surfaces 8 from driving the safety gate 95 from the unlatched position toward the latched position.
Thus, once the alignment pin 90 is moved to the aligned position as shown in Figure 3, the means 94 also prevents the alignment pin 90 frog moving from the alignment position toward the release position when the cartridge assembly 32 is in the closed position. This feature prevents a user from (1) clamping the stapler 10 on the tissue to be stapled and (2) thereafter moving the alignment pin 90 from the alignment position.
Figure 4 shows the positions of the anvil frame 12 and the cartridge assembly 32 just before the stapler 10 is fired. Attar the cartridge assembly 32 is moved to the closed position, the pawl 60 moves to the ucond position with the cam surface 67 generally engaged with the cam shoulder surface 49 of the raa 48. In this ~s position, the stapler 10 is ready to be fired. 11 second movement o! the lover part Z5 lrom the releau position to the actuation position (Figure 5) cauus the ram 48 to cove distally relative to the cartridge transport member and the anvil frame iZ, which drives the pusher 4Z

2~1~896 distally to eject the staples 41 from the cartridge housing 40 to press the staples 41 against the specially shaped anvil surfaces 23 and to engage and close the staples 41 in tissues between the cartridge housing 40 and the anvil jaw portion 22.
Once the cartridge assembly 32 is moved to the closed position, the spring 51 biases the cartridge assembly toward the open position but is prevented from moving the cartridge assembly 32 to the open position by engagement between a stop flange 66 of the toggle joint linkage 52 with another portion of the toggle joint linkage 52 generally adjacent the over center pivoting portion 53. Optionally, engagement between the toggle joint linkage 52 and surfaces on the handle housing Z4 may prevent further movement of the toggle joint linkage 52. A torsion spring (not shown) prevents the toggle joint linkage from accidentally "popping-up" or returning to the retracted position when the stapler 10 is fired.
After the stapler 10 is fired, the user may control the return of the cartridge assembly 32 to the open position by moving manually activatable release button 72 "upward" to engage surfaces 73 of release arm 70 with shoulder portions or pin 67 of the pawl 60 and to ' engage laterally inwardly projecting surfaces (not shown) on the arm 70 with the over center portion 53 of the toggle joint linkage 52 to move the pawl 60 from the second toward the first position and to move the toggle joint linkage 52 from the extended toward the retracted position against the bias of the torsion spring (not shown). Such a movement of the release era 70 allows the spring 51 to return the cartridge assembly 3Z to the open position.
Once the cartridge assembly 3Z is moved to the ' open position, the return caa surfacae 8 era Eras to drive the safety gate 95 into engagement with the safety notch 92 to prevent the cartridge assembly 32 lroa moving from the open to the closed position unless the alignaant v pin 90 is again moved to the alignment position. Thus, ~~r zi.~ ~'~ '~l:'' ' y ,.; ~ a <~

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this feature operates continuously, even if the stapler y is subsequently reused in the same patient.
As best seen in Figure 13, after the stapler 10 is fired and the cartridge assembly 32 is moved to the open position, the pusher 42 is located closer to the cartridge housing 40 than in the pre-fired position so that the second end of pin 82 no longer engages the edge , 43 of pusher 42. Thus alter the ram 48 moves back to the open position, the spring 86 biases the pin 82 lrom the free-travel to the blocking position with the lirst and 83 of the locking pin 82 projecting beyond the safety aperture 81 and into the path of the ram 48 to thereby prevent movement of the cartridge assembly 32 from the open to the closed position. It should be pointed out that the pin 82 will not only prevent the stapler 10 from firing when loaded with a spent cartridge, but will also prevent the firing of the stapler 10 when the stapler is not loaded with a cartridge housing 40 at all.
hlso, the pin 82 prevents firing o! the stapler 10 should the fired cartridge housing be replaced. with another fired cartridge, since the edge portion of the pusher of the fired cartridge would not be able to move the pin 82 from the blocking to the free-travel position. ...
The stapler 10 can be refined only by replacing the fired cartridge housing with an unfired or ready-to-fire cartridge housing 40 having an edge surface 43.of the pusher 42 in the proper position to move the pin 82 to the lree-travel position.
It should ba noted that the aechanical advantage provided by the toggle joint linkage 52 is at its minimum when the cartridge assembly 32 is in the open position and generally increases as the cartridge assembly 32 moves toward the closed position. Thus, it is important to prevent the cartridge assembly 32 from moving lrom the open toward the closed position to thereby minimize the shear !once transmitted through the toggle joint linkage 52 to the pin 82.
Figures 15 through 17 illustrate a second embodiment of surgical stapler generally designated by y~ ; . , :.. , . ::
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the reference character 100 which has many parts that are essentially the same ae the parts of the stapler 10 and which have been identified by the same reference numeral to which the suffix "A" has been added. Like the stapler 10, the stapler 100 includes comprises an anvil frame 12A
having proximal and distal 16A ends and a pair of lateral side portions 17A and 18A that are each elongate in a longitudinal direction and spaced to define a channel therabetween. The anvil !rams 12A has a handle portion (not shown but generally identical to the handle i9 of stapler 10) generally adjacent the proximal end with first and second ends, and a jaw portion 22A having specially shaped anvil surfaces 23A generally adjacent the distal end 16A. The anvil surfaces 23A are positioned in a plane generally perpendicular to the longitudinal direction. The jaw portion 22A includes surfaces defining an alignment aperture 15A opening onto the anvil surfaces 23A.
Like the stapler 10, the stapler 100 includes a cartridge assembly 32A having proximal and distal 31A
ends that is mounted in the channel between the lateral side portions 17A and 38A for longitudinal movement relative to the anvil frame-12A. The cartridge assembly 32A comprises a cartridge transporting msmber 35A having lirst and second side portions that are each elongate in the longitudinal direction and that are spaced to define a ram channel thsrsbstvean. The first and second side portions have surfaces defining a cartridge groove 38A
generally adjacent the distal end 3111 of the cartridge assembly 32A. The cartridge groove surfaces 38A are adapted to relsasably receive a cartridge housing 4011.
Ths cartridge housing IoA includes a plurality of staples I1A disposed in sows oriented in planes generally perpendicular to the longitudinal direction and positioned in opposition to the anvil surface 23A, and manually activatable scans, such as a pusher 42A, for pressing the staples 1111 within longitudinal slots in the cartridge housing IOA against the specially shaped anvil surfaces 2311 to, engage and close the staples I1A in N:l:~~~~~
_ 29 tissue between the cartridge housing 4011 and the anvil surfaces 23A. The pusher 42A has a pair of edges 43A and is positioned proximate the staples 41A for movement between pre-fired (Figure 15j and fired (Figure 16) positions with the pusher 42A adapted to move distally relative to the cartridge assembly 32A when the stapler 100 is fired. The cartridge housing 40A also has surfaces defining a close fitting hole or alignment through passage positioned in opposition to the alignment .
aperture 15A in the anvil frame 12A. The alignment through passage and the alignment aperture 15A may ba generally cylindrical and coaxial.
An elongate T-bar or ram 48A is mounted in the ram channel between the lirst and second side portions of the cartridge transport member 35A for longitudinal movement relative to the cartridge transporting member 35A and the anvil frame 12A. The T-bar or ram 48A is adapted to drive the pusher 42A distally to eject the staples 41A from the cartridge housing 40A to press the staples 41A against the specially shaped anvil surfaces 23A and to engage and close the staples 41A in tissues between the cartridge housing 40A and the anvil jaw portion 22A when the cartridge housing 40A the anvil surfaces 23A are fn the closed position.
Unlike the stapler 10, the stapler 100 includes a different aeans 102 for preventing the cartridge assembly 32A from moving from the open to the closed position when the stapler 100 is loaded with a cartridge housing 40A with the pusher 42A in a fired position.
Lika the means 80, the aaans i02 prevents approximation and clamping of living tissue between anvil (e. g. 23A) and cartridge (e.g. 40A) components of the stapler 100 when the stapler 100 is loaded with a spent stapler cartridge, and prevents Tiring o! the stapler 100 when the stapler l00 is loaded with a spent stapler cartridge.
The means 102 comprises the anvil lrame 12A .
having surfaces defining a safety aperture 103 opening into the surface of the anvil frame 12A and having a bottom surface, a locking notch il0 in the cartridge ~~~.~~~n transport member 35A of the cartridge assembly 32A, and a locking plate or pin 104 having first 105 and second 106 ends.
. The locking pin 104 is mounted within the safety aperture 103 for movement between a free travel position (Figure 15) with the first end 105 of the locking pin 104 generally abutting an edge 43A of the pusher 42A and spaced from the locking notch 110 to afford a single, reciprocating movement of the cartridge l0 assembly 32A between the open and closed positions, and a blocking position (Figure 16) with the first end 105 of the locking pin 104 projecting beyond the safety aperture 103 and engaged with the surfaces of the locking notch 110 to prevent movement of the cartridge assembly 32A
from the open to the closed position. Biasing means, such as a coil spring 109 having a first end connected to the second end 106 of the locking pin 104 and a second and connected to the bottom surface of the safety aperture 103, biases the locking pin 104 toward the 2o blocking position.
Figures 20 and 21 illustrate a third embodiment of surgical stapler according to the present invention generally designated by the-reference character 200 which has many parts that are essentially the sane as the parts of the stapler 100 and which have been identified by the same reference numeral to which the suffix ~B" has been added. Like the stapler 100, the stapler 200 includes comprises an anvil frame 12B which is elongate in a longitudinal direction. The anvil frame 12B has a handle portion (not shown but generally identical to the handle 19 0! stapler 10) , and a jaw portion 22B having specially shaped anvil surfsces (not shown but generally identical to the anvil surfaces 23 and 23A). Tha anvil surfaces are positioned in a plane generally perpendicular to the longitudinal direction. Tha jaw portion 228 includes surlaces defining an alignment aperture opening onto the anvil surfaces.
Like the stapler 100, the stapler 200 includes a cartridge assembly 32B that is mounted for longitudinal 2~118~u movement relative to the anvil frame 128. The cartridge assembly 32B comprises a cartridge transporting member 35B surfaces defining a cartridge groove generally adjacent a distal end of the cartridge assembly 328. Tha cartridge groove surfaces are adapted to releasably receive a cartridge housing (not shown but generally identical to the cartridge housings 40 and 40A).
The cartridge housing includes a plurality of staples (not shown but generally identical to the staples l0 41 and 41) disposed in rows oriented in planes generally perpendicular to the longitudinal direction and positioned in opposition to the anvil surfaces and manually activatable means, such as a pusher 428, !or pressing the staples within longitudinal slots in the cartridge housing against the specially shaped anvil surfaces to engage and close the staples in tissue between the cartridge housing and the anvil surfaces.
The pusher 42A has a pair of edges 43B and is positioned proximate the staples for movement between pre-fired (Figure 20) and fired (Figure 21) positions with the pusher 42B adapted to move distally relative to the cartridge assembly 32B when the stapler 200 is fired. ~ .
The cartridge housing also has surfaces defining a close fitting hole or alignment through passage positioned in opposition to an alignment aperture in the anvil frame 128. The alignment through passage and the alignment aperture say be generally cylindrical and coaxial.
7~n elongate T-bar or ram 488 is mounted in the ram channel between the first and second side portions of the cartridge transport member for longitudinal movement relative to the cartridge transporting aeaber and the anvil lrame 128. The T-bar or ram 488 is adapted to drive the pusher 42B distally to eject the staples from the cartridge housing to press the staples against the w specially shaped anvil surfaces and to engage and close the staples in tissues between the cartridge housing and the anvil jaw portion 228 when the cartridge housing the anvil surfaces are in the closed position.

Unlike the stapler 100, the stapler 200 includes a different means 202 for preventing the cartridge assembly.32H from moving from the open to th_e closed position unless the stapler 200 is loaded with a ready-to-fire cartridge housing. Like the means 102, the means 202 prevents approximation and clamping of living tissue between anvil and cartridge components o! the stapler 200 when the stapler 200 is unloaded or loaded with a spent stapler cartridge, and prevents tiring of the stapler 200 when the stapler 200 is unloaded or loaded with a spent stapler cartridge.
hlso like the means 102, the means 202 comprises the anvil frame 128 having surfaces defining a safety aperture 103B opening into the surface of the anvil frame 12B and having a bottom surface. Unlike the means 102, the means 202 includes a locking notch 210 in the cartridge transport member of the cartridge assembly 32B having sloped surfaces 220, and a locking plate or pin 204 having first 205 and second 206 ends with a romped caroming surface 230 generally adjacent the first end 205.
The locking pin 204 is mounted within the safety aperture 103B for movement between a free travel position (Figure 20) with the first end 205 of the locking pin 204 generally abutting an edge of the pusher 42B and spaced from the locking notch 210 to aflord a single, reciprocating movement of the cartridge assembly 32B between the open and closed positions, and a blocking position (Figure 16) with the first and 205 of the locking pin 204 projecting beyond the safety aperture 1038 and engaged with the surfaces of the locking notch 210 to prevent aoveaent o! the cartridge assembly 328 Eros the open to the closed position.
Biasing aeons such as a coil spring i09B having a first and connected to the second end 206 0! the locking pin 204 and a second end connected to the bottom surface of the safety aperture 103B biases the locking pin 204 toward the blocking position.

21~~3~ii Optionally, either the locking notch 210 and/or the locking pin 204 may have sloped or camped caroming surfaces to cam the locking pin 204 to the free travel position when the cartridge assembly initially moves from the open to the closed position, but which does not cam the locking pin 204 to the free-travel position when the stapler is unloaded or when the stapler is loaded with a staple cartridge other than a ready-to-fire staple cartridge.
The means 202 is believed to provide a mechanism which is easier to construct than the means 102 as the sloped surlaces 220 and the camped caroming surface 230 era believed to be lass sensitive to individual part differences or tolerances, in for example, the relative positions of the cartridge housing 40H, the cartridge transport member 35B and the edge 43H of the pusher 428.
The present invention has now been described with reference to several embodiments thereof. It will be apparent to those skilled in the art that many changes can be made in the embodiment described without departing from the scope of the present invention. For example, the pin 82 and the spring 86 may be replaced with a plastic part with an integrally molded spring. ~rlso, the pin 104 may be adapted to engage a slot (not shown) in the cartridge housing 40~r rather than the locking notch 110 in the cartridge assembly 32. l~dditionally, the aaans 94 could be completely eliminated lrom the stapler l0 according to the present invention, and the anvil fraaa 12 and the cartridge assembly 32 say be constructed frow any suitable material such as but not limited to a metal or plastic material. Noraover, the locking plate or pins 82, 104, 204 may be constructed lrom any suitable, tough aaterial such as metal or plastic and may have arcuate portions (not shown) adjacent their ands which are adapted to engage the edge (e.g. 43H) of the pusher. The arcuate edges cam the pins toward the free trawl position when the stapler is loaded with an unfired cartridge and the cartridge assembly initially coves toward the closed position. Thus the scope o! the '; ' y ;~:, ~ , ; :;. - , .. - ;.. ; :. ..
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Claims (15)

CLAIMS:

1. a surgical stapler comprising:
an anvil frame having proximal and distal ends and a pair of lateral side portions each being elongate in a longitudinal direction and spaced to define a channel therebetween, said anvil frame having a handle portion generally adjacent said proximal end and having first and second ands, and a jaw portion having specially shaped anvil surfaces generally adjacent said distal end and positioned in a plane generally perpendicular to said longitudinal direction, said jaw portion including surfaces defining an alignment aperture opening onto said anvil surfaces, an elongate manually movable handle part having first and second ends, said handle part having pivot means at said second end adapted for affording relative pivotal movement of said handle part and said anvil frame between a release position with said first end of said handle part being spaced from said first end of said handle portion and an actuation position with said handle part and said handle portion in closely spaced relationship;

biasing means for biasing said handle portion toward said release position, a cartridge assembly having proximal and distal ends and being mounted in said channel between said lateral side portions for longitudinal movement relative to said anvil frame;
said cartridge assembly comprising:
a cartridge transporting member having first and second side portions each being elongate in said longitudinal direction and being spaced to define a ram channel therebetween, said first and second side portions having surfaces defining a cartridge groove generally adjacent said distal end of said cartridge assembly, said cartridge groove surfaces being adapted to releasably receive a cartridge housing containing a plurality of staples disposed in rows positioned in opposition to said anvil surfaces, the cartridge housing having surfaces defining an alignment through passage positioned in opposition to the alignment aperture, means mounting said cartridge assembly for longitudinal movement relative to said anvil frame between a closed position with said cartridge housing and said anvil surfaces in closely spaced relationship, and an open position with said cartridge housing and said anvil surfaces spaced farther from each other than in said closed position, an elongate ram being mounted in said ram channel between said first and second side portions for longitudinal movement relative to said cartridge transporting member and said anvil frame, said ram being adapted for ejecting the staples from the cartridge housing to press the staples against said anvil surfaces and to engage and close the staples in tissues between said cartridge housing and said anvil jaw portion when said cartridge housing and said anvil surfaces are in said closed position, actuation means operable in a first movement of said handle part from said release to said actuation positions to initially move said cartridge assembly from said open to said closed positions and operable in a second movement of said handle part from said release to said actuation positions to subsequently fire said stapler by moving said ram distally relative to said cartridge transporting member to eject the staples from the cartridge housing to press the staples against said anvil surfaces and to engage and close the staples in tissues between said cartridge housing and said anvil jaw portion, means for biasing said cartridge assembly from said closed to said open position, and a safety guide member comprising;
a sleeve having proximal and distal ends and being slidably counted on said anvil frame for longitudinal movement relative thereto, a longitudinally extending alignment pin mounted on acid distal end of said sleeve for movement between an alignment position with said pin passing through said cartridge housing alignment through passage and extending into said alignment aperture to position said rows of staples relative to said specially shaped surfaces on said anvil to afford a sore precisely controlled formation of fired staples and to prevent tissue from escaping from between the cartridge housing and the anvil surfaces when the cartridge assembly is moved to the closed position, and a release position with said alignment pin spaced from said alignment through passage and said alignment aperture to afford removal and replacement of said cartridge housing with a new cartridge housing, and means, mounted on said safety guide member, for repeatably and continuously preventing said cartridge assembly from moving from said open to said closed position unless said alignment pin is in said alignment position.

2. A surgical stapler comprising:
an anvil frame having proximal and distal ands and a pair of lateral side portions each being elongate in a first longitudinal direction and spaced to define a channel therebetween, said anvil frame having a handle portion generally adjacent said proximal end and having first and second ends, and a jaw portion having specially shaped anvil surfaces generally adjacent said distal end and positioned in a plane generally perpendicular to said first longitudinal direction, said jaw portion including surfaces defining an alignment aperture opening onto said anvil surfaces, an elongate manually movable handle part having first and second ends, said handle part having pivot means at said second and adapted for affording relative pivotal movement of said handy part and said anvil frame between a release position with said first end of said handle part being spaced from said first end of said handle portion and an actuation position with said handle part and said handle portion in closely spaced relationship;
biasing means for biasing said handle portion toward said release position, a cartridge assembly having proximal and distal ends and being mounted in said channel between said lateral side portions for longitudinal movement relative to said anvil frame;
said cartridge assembly comprising:
a cartridge transporting member having first and second side portions each being elongate in said longitudinal direction and being spaced to define a ram channel therebetween, said first and second side portions having surfaces defining a cartridge groove generally adjacent said distal end of said cartridge assembly, said cartridge groove surfaces being adapted to releasably receive a cartridge housing containing a plurality of staples disposed in rows positioned in opposition to said anvil surfaces, the cartridge housing having surfaces defining an alignment through passage positioned in opposition to the alignment aperture, and means mounting said cartridge assembly !or longitudinal movement relative to said anvil frame between a closed position with said cartridge housing and said anvil surfaces in closely spaced relationship, and an open position with said cartridge housing and said anvil surfaces spaced farther from each other than in said closed position, an elongate ram being mounted in said ram channel between said first and second side portions for longitudinal movement relative to said cartridge transporting member and said anvil frame, said ra~ being adapted for ejecting the staples from the cartridge housing to press the staples against said anvil surfaces and to engage and close the staples in tissues between said cartridge housing and said anvil jaw portion when said cartridge housing and said anvil surfaces era in said closed position, actuation means operable in a first movement of said handle part from said release to said actuation positions to initially move said cartridge assembly from said open to said closed positions and operable in a second movement of said handle part from said release to said actuation positions to subsequently fire said stapler by moving said ram distally relative to said cartridge transporting member to eject the staples from the cartridge housing to press the staples against said anvil surfaces and to engage and close the staples in tissues between said cartridge housing and said anvil jaw portion, means for biasing said cartridge assembly from said closed to said open position, and a safety guide member comprising:
a sleeve having proximal and distal ends and being slidably mounted on said anvil frame for longitudinal movement relative thereto, a longitudinally extending alignment pin mounted on said distal end of said sleeve for movement between an alignment position with said pin passing through said cartridge housing alignment through passage and extending into said alignment aperture to position said rows o! staples relative to said specially shaped surfaces on said anvil to afford a more precisely controlled formation of fired staples and to prevent tissue from escaping from between the cartridge housing and the anvil surfaces when the cartridge assembly is moved to the closed position, and a release position with said alignment pin spaced from said alignment through passage and said alignment aperture to afford removal and replacement of said cartridge housing with a new cartridge housing, and means for repeatably and continuously preventing said cartridge assembly from moving from said open to said closed position unless said alignment pin is in said alignment position comprising:
said anvil frame, cartridge transport member and ram each having surfaces defining safety notches which are aligned when said cartridge assembly is in said open position, a safety gate having cam shoulder surfaces and surfaces defining a hole, said safety gate being mounted adjacent said anvil frame for relative movement thereto between a latched position with the safety gate engaged with the surfaces defining the safety notches to prevent relative movement between the cartridge assembly and the anvil frame when the cartridge assembly is in said open position, and an unlatched position with the safety gate spaced from said safety notches to afford relative movement of the cartridge assembly and the anvil frame between the open and closed positions, and said safety guide member including safety gate deactivating guides projecting proximally from the proximal end of said sleeve and through said safety gate hole, said guides being adapted to drive said safety gate toward said latched position when the alignment pin is in a position other than the alignment position and having cam surfaces at a proximal end adapted to engage the cam shoulder surfaces of said safety gate to drive the safety gate from said latched to said unlatched position when the alignment pin is moved to the alignment position.

3. A stapler according to claim 22 wherein said stapler includes means for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position comprising:
said safety gate deactivating guides having return cam surfaces generally opposite said cam surfaces adapted to engage surfaces on said safety gate to drive the safety gate from the unlatched toward the latched position when the alignment pin is moved away from the alignment position, and surfaces on said cartridge transport member and ram adapted to engage the safety gate to prevent the alignment pin from moving from the alignment position toward the release position when the cartridge assembly is in the closed position.

4. A surgical stapler comprising:
an elongate anvil including anvil surfaces in a plane generally perpendicular to the direction of elongation of said anvil and surfaces defining an alignment aperture opening onto said anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surfaces and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, a longitudinally extending alignment pin assembly mounted on said stapler for movement between an alignment position with said alignment pin assembly extending into said alignment aperture, and a release position with said alignment pin assembly spaced from said alignment aperture, and means, mounted on said alignment pin assembly, adapted to engage said cartridge assembly for repeatedly and continuously preventing said cartridge assembly from moving from said open toward said closed position whenever said alignment pin is in a position other than said alignment position.

5. A stapler comprising:
an elongate anvil including anvil surfaces in a plane generally perpendicular to the direction of elongation of said anvil, and surfaces defining an alignment aperture opening onto said anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surfaces and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, a longitudinally extending alignment pin mounted on said stapler for movement between an alignment position with said alignment pin extending into said alignment aperture, and a release position with said alignment pin spaced from said alignment aperture, and means adapted to engage said cartridge assembly for repeatedly and continuously preventing said cartridge assembly from moving from said open toward said closed position whenever said alignment pin is in a position other than said alignment position comprising:
surfaces defining a safety notch in said cartridge assembly and anvil when said cartridge assembly is in said open position, a safety gate having cam shoulder surfaces and surfaces defining a hole, said safety gate being mounted adjacent said anvil for relative movement thereto between a latched position with the safety gate engaged with the surfaces defining the safety notch to prevent relative movement between the cartridge assembly and the anvil, and an unlatched position with the safety gate spaced from said safety notch to afford relative movement of the cartridge assembly and the anvil between the open and closed positions, and a safety guide member including a sleeve with safety gate deactivating guides projecting proximally from a proximal and of said sleeve and through said safety gate hole, said guides being adapted to bias said safety gate toward said latched position when the alignment pin is in a position other than the alignment position and having cam surfaces at a proximal end adapted to engage the cam shoulder surfaces of said safety gate to drive the safety gate from said latched to said unlatched position when the alignment pin is moved to the alignment position.

6. stapler according to claim 5 wherein said cartridge assembly includes a cartridge transport member, said stapler includes a ram, and said stapler includes means for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position comprising:
said safety gate deactivating guides having return cam surfaces generally opposite said cam surfaces, said return cam surfaces being adapted to engage surfaces on said safety gate to drive the safety gate from the unlatched toward the latched position when the alignment pin is moved away from the alignment position, and surfaces on said cartridge transport member and ram adapted to engage the salety gate to prevent the return caroming surfaces from driving the safety gate to the latched position to thereby prevent the alignment pin from moving lrom the alignment position toward the release position when the cartridge assembly is in the closed position.

7. A surgical stapler comprising:
an anvil elongate in a longitudinal direction and including anvil surfaces in a plane generally perpendicular to said longitudinal direction and surfaces defining an alignment aperture opening onto said anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surfaces and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, a longitudinally extending alignment pin mounted on said stapler for movement between an alignment position with said alignment pin extending into said alignment aperture, and a release position with said alignment pin spaced from said alignment aperture, and means for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position.

8. A surgical stapler comprising:
an anvil elongate in a longitudinal direction and including anvil surfaces and surfaces defining an alignment aperture opening onto said anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced lrom said anvil surlaces and a closed position with maid cartridge assembly and said anvil surfaces in closely spaced relationship, a longitudinally extending alignment pin mounted on said stapler for movement between an alignment position with said alignment pin extending into said alignment aperture, and a release position with said alignment pin spaced from said alignment aperture, and weans adapted to engage said cartridge assembly !or continuously preventing said cartridge assembly from moving from said open to said closed position whenever said alignment pin is in a position other than said alignment position, and for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position.

9. A surgical stapler comprising:
an anvil elongate in a longitudinal direction and including anvil surfaces in a plane generally perpendicular to said longitudinal direction and surfaces defining an alignment aperture opening onto said anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surfaces and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, a longitudinally extending alignment pin mounted on said stapler for movement between an alignment position with said alignment pin extanding into said alignment aperture, and a release position with said alignment pin spaced from said alignment aperture, and means for continuously preventing said cartridge assembly lrom moving from said open to said closed position whenever said alignment pin is in a position other than said alignment position, and for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position.

10. A stapler according to claim 9 wherein said means for continuously preventing said cartridge assembly from moving from said open to said closed position whenever said alignment pin is in a position other than said alignment position, and for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position comprises:
a safety guide member comprising:
a sleeve having proximal and distal ends and being slidably mounted on said anvil for longitudinal movement relative thereto, said anvil and cartridge assembly each having surfaces defining safety notches which are aligned when said cartridge assembly is in said open position and which are staggered when said cartridge assembly is in said closed position, a safety gate having cam shoulder surfaces and surfaces defining a hole, said safety gate being mounted adjacent said anvil for relative movement thereto between a latched position with the safety gate engaged with the surfaces defining the safety notches to prevent relative movement between the cartridge assembly and the anvil when the cartridge assembly is in said open position, and an unlatched position with the safety gate spaced lrom said safety notches to a!lord relative movement of the cartridge assembly and the anvil between the open and closed positions, said salety guide member including safety gate deactivating guides projecting proxisally from the proximal end o! said sleeve and through said safety gate hole, said guides having return cam surfaces to bias said salaty gate toward said latched position when the alignment pin is in a position other than the alignment position and having cam surfaces generally opposite said return cam surfaces that are adapted to engage the cam shoulder surfaces of said safety gate to drive the safety gate from said latched to said unlatched position when the alignment pin is moved to the alignment position, and surfaces on said cartridge assembly adapted to engage the safety gate to prevent the alignment pin from moving from the alignment position toward the release position when the cartridge assembly is in the closed position.

11. a surgical stapler comprising:
an elongate anvil including anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surfaces and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, an alignment pin mounted on said stapler for movement between an alignment position adapted to align the cartridge assembly with said anvil and a release position with said alignment pin spaced from said anvil, and means for preventing said alignment pin from moving from said alignment position toward said release position when said cartridge assembly is in said closed position.

12. A surgical stapler comprising:
an elongate anvil including anvil surfaces, a cartridge assembly movable relative to said anvil between an open position with the cartridge assembly spaced from said anvil surlacea and a closed position with said cartridge assembly and said anvil surfaces in closely spaced relationship, an alignment pin assembly mounted on said stapler for movement between an alignment position adapted to align the cartridge assembly with said anvil surfaces and a release position with said alignment pin assembly spaced from said anvil surfaces, and means, mounted on said alignment pin assembly, for continuously and repeatedly preventing said cartridge assembly from moving from said open toward said closed position whenever said alignment pin assembly is in a position other than said alignment position.

13. A stapler according to claim 12, wherein said stapler includes surfaces defining a safety notch in said cartridge asaembly and anvil when said cartridge assembly is in said open position, and said means, mounted on said alignment pin assembly comprises:
a safety gate having cam shoulder surfaces and surfaces defining a hole, said safety gate being mounted on said alignment pin assembly for relative movement thereto between a latched position with the safety gate engaged with the surfaces defining the safety notch to prevent relative movement between the cartridge assembly and the anvil, and an unlatched position with the safety gate spaced from said salety notch to afford relative movement of the cartridge assembly and the anvil between the open and closed positions.

14. A stapler according to claim 13 wherein said alignment pin assembly comprises a safety guide member including a sleeve with safety gate deactivating guides projecting proximally from a proximal end of said sleeve and through said safety gate hole, said guides being adapted to bias said safety gate toward said latched position when the alignment pin assembly is in a position other than the alignment position and having cam surfaces at a proximal end adapted to engage the cam shoulder surfaces of said safety gate to drive the safety gate from said latched to said unlatched position when the alignment pin assembly is moved to the alignment position.

15, A stapler according to claim 14 wherein said cartridge assembly includes a cartridge transport member, said stapler includes a ram, and said stapler includes means for preventing said alignment pin assembly from moving from said alignment position toward said release position when said cartridge assembly is in said closed position comprising:
said safety gate deactivating guides having return cam surfaces generally opposite said cam surfaces, said return cam surfaces being adapted to engage surfaces on said safety gate to drive the safety gate from the unlatched toward the latched position when the alignment pin assembly is moved away from the alignment position, and surfaces on said cartridge transport member and ram adapted to engage the safety gate to prevent the return caroming surfaces from driving the safety gate to the latched position to thereby prevent the alignment pin assembly from moving from the alignment position toward the release position when the cartridge assembly is in the closed position.