US20080197167A1 - Surgical stapler with timer and feedback display - Google Patents

Abstract

A surgical apparatus has a clamp and a stapling mechanism. The clamp has a first jaw and a second jaw to clamp on a body tissue at a desired location for a stapling operation. The stapling mechanism is controlled by a trigger handle or a switch assembly. The surgical apparatus has a controller for providing a delay between clamping and actuating of the firing mechanism of the stapling mechanism. The delay provides for a desired amount of time for tissue compression producing a more uniform staple formation. The surgical apparatus also has an indicator. The indicator provides feedback about the status of the stapling mechanism and also displays a time of tissue compression by the clamp.

Description

CROSS REFERENCE TO RELATED PATENT APPLICATIONS
• This patent application claims priority to U.S. Provisional Patent Application Ser. No. 60/687,406 to Viola, et al., filed on Jun. 3, 2005 which is herein incorporated by reference in its entirety. This patent application also claims priority to U.S. Provisional Patent Application Ser. No. 60/687,244 to Viola, et al., filed on Jun. 3, 2005 which is also herein incorporated by reference in its entirety. This patent application also relates to U.S. patent application Ser. No. ______to Viola, et al, (Attorney Docket No. H-US-00377 (2034730) filed contemporaneously with the instant patent application which is herein incorporated by reference in its entirety.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to surgical instruments. More particularly, the present disclosure relates to a surgical stapling device that has a feedback and a timer device. Even more particularly, the present disclosure relates to a surgical stapling device that has a controller to modulate one or more parameters of the surgical stapling device and to provide for compression of tissue. Still even more particularly, the present disclosure relates to a surgical stapling device that may also include a sensory indicator (i.e., visual, audible, tactile) which determines position, time, or other valuable user feedback.
• 2. Background of the Related Art
• Once under pressure from a jawed structure, such as a clamping device, of a surgical stapler, the body tissue will slowly compress. Compression by a clamping device reduces the amount of blood and fluid to the clamped tissue. Without such compression, an uncompressed body tissue remains thicker whereas the compressed body tissue would be thinner, and more compact. Compressing the tissue also causes blood and other fluid to generally traverse from the high pressure or compressed area to another low pressure or adjacent area.
• Once released, the fluid due to the visco-elastic property of the tissue will return from the adjacent area to the previously compressed tissue. Some current surgical stapling devices initially compress tissue prior to the introduction of the staple into the body tissue. The amount of time tissue is compressed is currently left to the discretion of the surgeon. The surgeon manually controls the amount of time that the tissue is compressed prior to firing the staples into tissue. It would be therefore desirable to have a surgical stapling device that consistently fires staples after a predetermined amount of compression.
SUMMARY
• According to a first embodiment of the present disclosure, there is provided a surgical stapler that has a handle assembly including a stationary handle and a pivotable handle mounted for manipulation through an actuating stroke. In another embodiment, the stapler may have a trigger that is operable to manipulate a cam member through the actuating stroke. The stapler also has an elongated body extending distally from the handle assembly and defining a longitudinal axis and a staple cartridge supported adjacent the distal end of the elongated body and containing a plurality of staples.
• The stapler further has an anvil pivotally mounted in relation to the cartridge adjacent the distal end of the elongated body with the anvil having a fastener forming surface thereon and being mounted for pivotal movement in relation to the cartridge between an open position having a distal end spaced from the staple cartridge and a closed position in close cooperative alignment with the staple cartridge. The stapler also has an actuation sled supported within the cartridge. The actuation sled moves to urge the plurality of staples from the cartridge.
• The stapler further has a drive assembly including a body having a working end and a cam member supported on the working end. The cam member is positioned to translate relative to the anvil to maintain the anvil in the closed position during firing of the stapler. The trigger or pivotable handle is operatively connected to the drive assembly such that manipulation of the pivotable handle through its actuating stroke effects translation of the cam member relative to the anvil. The stapler also has a channel for supporting the staple cartridge and a controller configured to control the actuation sled supported within the cartridge. The controller delays movement of the actuation sled to urge the plurality of staples from the cartridge for a predetermined time period when the anvil is in the closed position and in cooperative alignment with the staple cartridge.
• According to another aspect of the present disclosure, the surgical stapler has a handle assembly including a stationary handle and a trigger configured to manipulate a cam member through an actuating stroke. The stapler also has an elongated body extending distally from the handle assembly and defining a longitudinal axis and a staple cartridge supported adjacent the distal end of the elongated body with staples. The stapler further has an anvil pivotally mounted in relation to the cartridge adjacent the distal end of the elongated body. The anvil has a fastener forming surface thereon and is mounted for pivotal movement in relation to the cartridge between an open position having a distal end spaced from the staple cartridge and a closed position in close cooperative alignment with the staple cartridge.
• The stapler also has an actuation sled supported within the cartridge. The actuation sled moves to urge the staples from the cartridge. The drive assembly includes a body having a working end and a cam member supported on the working end. The cam member is positioned to translate relative to the anvil to maintain the anvil in the closed position during firing of the stapler.
• The trigger is connected to the drive assembly such that manipulation of the trigger through its actuating stroke effects translation of the cam member relative to the anvil. The stapler also has a channel for supporting the staple cartridge. The stapler also has a controller. The controller is configured to control the actuation sled supported within the cartridge. The controller delays the actuation sled's movement to urge the plurality of staples from the cartridge for a predetermined time period when the anvil is in the closed position and in cooperative alignment with the staple cartridge. The surgical stapler also has an indicator connected to the controller. The controller controls the indicator to provide an indication when the predetermined time period is reached.
• According to another embodiment of the present disclosure, there is provided a method for stapling tissue. The method includes the steps of locating tissue between a staple cartridge and an anvil and compressing tissue between the staple cartridge and the anvil. The method also has the step of manipulating an actuator to fire staples from the staples cartridge. The actuator is configured to automatically delay firing staples for a predetermined time period. The predetermined time period is suitable in length to allow compression of the tissue for the predetermined time period and to allow tissue to settle from a first initial state into a second compressed state. The method also has the steps of urging staples from the staple cartridge through the tissue at the elapse of the predetermined time period when the tissue is in the second compressed state.
• According to another aspect of the present disclosure, the surgical stapler has a controller to place a delay between actuation of the firing mechanism component and actual firing of the staple.
• According to another aspect of the present disclosure, the surgical stapler has a control device that controls a stroke parameter, a distance parameter and/or a time parameter of a firing mechanism component to increase a tissue compression time of the clamp.
• According to still another aspect of the present disclosure, the surgical stapler has a motor and a first switch. The first switch is connected to a motor and delays the motor from actuating in order to achieve an amount of tissue compression by a clamp. The surgical stapler may have a second switch. The second switch senses another location of a drive screw and actuates a reverse function of the motor to return the drive screw to an initial position.
• According to still yet another aspect of the present disclosure, the surgical stapler has an indicator that measure a distance traveled of the drive screw or a tissue compression time of the clamp.
• According to still another aspect of the present disclosure, the surgical stapler has a visual indicator that indicates a position of the firing mechanism component or indicates a status condition of the surgical stapling.
• In another embodiment of the present disclosure, there is provided a surgical stapler. The stapler has a handle assembly including a trigger and a clamping device with a staple cartridge including a plurality of staples and an anvil having a fastener forming surface thereon. The stapler has a controller configured to determine an occurrence of clamping by the anvil and the staple cartridge. The controller controls a firing of the plurality of staples from the staple cartridge. When the trigger is actuated the controller delays firing of the plurality of staples from the staple cartridge to provide for a predetermined time period of tissue compression of the tissue between the anvil and staple cartridge. The controller outputs a control signal to allow firing once the predetermined time period is reached.
DESCRIPTION OF THE DRAWINGS
• Other and further objects, advantages and features of the present disclosure will be understood by reference to the following specification in conjunction with the accompanying drawings, in which like reference characters denote like elements of structure and:
• FIG. 1 is a perspective view of a first embodiment of a surgical stapler of the present disclosure;
• FIG. 2 is a block diagram of a number of components of the surgical stapler ofFIG. 1;
• FIG. 2A is an exploded view of a channel of the surgical stapler ofFIG. 1;
• FIG. 2B is an exploded view of the staple cartridge, anvil and the drive sled ofFIG. 1;
• FIG. 3 is a perspective view of another embodiment of the surgical stapler of the present disclosure having a plurality of lights;
• FIG. 4 is a perspective view of still another embodiment of the surgical stapler with a linear indicator or display;
• FIG. 5 is a perspective view of yet another embodiment of the surgical stapler having a digital indicator or display;
• FIG. 6 is a perspective view of still another embodiment of the surgical stapler with an analog indicator or display;
• FIG. 7 is a cross sectional view of the surgical stapler ofFIG. 3 along line7-7;
• FIG. 8 is another cross sectional view of still another embodiment of the surgical stapler of the present disclosure along line7-7 ofFIG. 3 with the stapler having a first switch and a second switch;
• FIG. 8A is another cross sectional view of another embodiment of the stapler ofFIG. 8 having the first switch which engages a tab on the lever;
• FIG. 8B is still another cross sectional view of yet another embodiment of the stapler ofFIG. 8 having the first switch located distally on the lever;
• FIG. 9 is another perspective view of still another embodiment of the surgical stapler with an audible alarm;
• FIG. 10 is still another perspective view of another embodiment of the surgical stapler having the display showing an image;
• FIG. 11 is a schematic/cross sectional view of a travel path of a drive member through an endoscopic portion of the surgical stapler with a resistor strip; and
• FIG. 12 is a schematic of another embodiment of the surgical stapler having a non-contact sensor.
DETAILED DESCRIPTION
• In the drawings and in the description which follows, the term “proximal”, as is traditional, will refer to the end of the apparatus which is closest to the operator, while the term “distal” will refer to the end of the apparatus which is furthest from the operator.
• The present disclosure can be used with any stapler device known in the art and is intended to encompass the same, and is intended to be discussed in terms of both conventional and endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic”, “endoscopically”, and “endoscopic portion”, among others, should not be construed to limit the present disclosure to an apparatus for use only in conjunction with an endoscopic tube. The apparatus of present disclosure may find use in procedures in these and other uses including but not limited to uses where access is limited to a small incision such as arthroscopic and/or laparoscopic procedures, or other conventional medical procedures. The present mechanism may also be used with surgical stapling devices that have independent or combined clamping and firing procedures. The present disclosure may further be incorporated with surgical stapling devices that have simultaneous or dependent clamping and firing mechanisms. The present disclosure is also intended to be used with such surgical stapling devices which have a discrete clamping gradient.
• Referring now to the figures, wherein like reference numerals identify similar structural elements of the subject disclosure, there is illustrated inFIG. 1 a self-contained, powered surgical stapler constructed in accordance with an embodiment of the subject disclosure and designated generally byreference numeral10. Thesurgical stapler10 is generally intended to be disposable, however the disposable arrangement is non-limiting and other non-disposable arrangements may be contemplated and are within the scope of the present disclosure.
• Thesurgical stapler10 of the present disclosure (shown in a perspective view inFIG. 1 and described herein) includes a frame generally represented byreference numeral12 and handle generally represented byreference numeral14. Theframe12 defines a series of internal chambers or spaces for supporting various inter-cooperating mechanical components of thesurgical stapler10 as well as a number of staples therein for the application to the body tissue.
• Theframe12 supports aportion16 or an extended tube-like portion. Theportion16 is capable of being rotated and has a relatively narrow diameter in a range of about 10 millimeters, and is for insertion into a small opening or tube inserted into the body, such as in the abdominal cavity, or other similar body cavities. Theportion16 has a longitudinal axis and has a length appropriate for reaching the operation site in the interior of the body. Thesurgical stapler10 may be used in conjunction with other instruments such as endoscopes or other such optical devices for visually examining the interior of the body, for example, cameras by means of CCD devices, fiber optics or other optical or recording devices.
• Generally,portion16 of thesurgical stapler10 is inserted through the small opening or wound, and is manipulated to the operation site. The present disclosure is intended to be used with any surgical stapler including but not limited to surgical staplers having simultaneous clamping and independent clamping.
• Portion16 has a fastening assembly generally represented byreference number18 and cutting assembly (not shown) that is known in the art. Thefastening assembly18 and the cutting assembly (not shown) are located in ahousing20 which carries a fastener and an optional cutter to the operation site. Thefastening assembly18 in this particular embodiment has a jaw or astaple cartridge21 and a second jaw oranvil22. Thestaple cartridge21 and theanvil22 may be brought into close cooperative alignment with one another so thejaws21,22 form a clamp therebetween. Thejaws21,22 may be a first and second jaw that open and close or may be another different clamping type structure as is known in the art. Thestaple cartridge21 may be located at the distal end of thehousing20, in thejaws21,22 themselves or may be located in other locations as described in U.S. Pat. No. 7,044,353 to Mastri, et al. which is herein incorporated by reference in its entirety. Thestaple cartridge21 has one or a number of rows of staples. Thesurgical stapler10 also has an anvil (not shown) and further may include an optional knife (not shown) as is well known in the art for accomplishing the stapling. It is appreciated that the closing of thejaws21,22 with thestaple cartridge21 and theanvil22 may be accomplished by pivoting theanvil22 relative to thestaple cartridge21, or by pivoting thestaple cartridge21 relative to theanvil22, or by pivoting both thestaple cartridge21 and theanvil22 relative to one another.
• Generally, actuating the operating portion of thefastening assembly18 is accomplished via intermediate components disposed on or within the narrow longitudinally extendingtubular portion16. In one non-limiting embodiment, a cylindrical tubular sleeve member surrounds theportion16. The sleeve may be manipulated in a direction with the longitudinal axis of the surgical stapling device. The sleeve slides onto theanvil22 for closing thejaws21,22 that are biased open by a biasing device (not shown) to accomplish the clamping. Thesurgical stapler10 of the present disclosure has three basic actions or functions, however, the present disclosure is intended to be used with any surgical stapler including but not limited to surgical staplers having simultaneous clamping (i.e., clamping and firing the stapler at the same time) and independent clamping (i.e., clamping prior to the staple firing).
• First,portion16 is introduced into the human or animal body and is positioned with thejaws21,22 aligned at the desired stapling site to receive the target tissue. This may involve rotation of theportion16 relative to the body, either by rotating thesurgical stapler10 as a whole, by rotating simply theportion16 relative to theframe12 as permitted, or a combination of both actions. Thereafter (i.e., secondly), thesurgical stapler10 secures the target body tissue between the staple cartridge orjaw21 in the distal portion of thehousing20 and theanvil22. This is accomplished by a clamping action of thejaws21,22 or alternatively by another similar or different clamping member.
• Thejaws21,22 are allowed to remain in the closed position for a desired period of time depending on the particular tissue. By configuring thejaws21,22 to remain closed for a predetermined period of time allows any excess liquid or fluid in the tissues to drain out of the body tissues prior to actuation of the staplingcartridge21. This ensures that the liquid does not traverse out of the tissues after firing to form non-uniform staples and instead ensures a proper and uniform staple formation.
• With the target tissue clamped between theanvil22 and thestaple cartridge21, a camming surface which surrounds thehousing20 andanvil22 is employed to close thejaws21,22 of thesurgical stapler10 and clamp the tissue between theanvil22 and the tissue contacting surface of thestaple cartridge21. Thejaws21,22 are clamped by actuation of alever24 opposite thejaws21,22 as is known in the art. Thereafter, the surgeon applies the staples to the body tissue. A longitudinally extending channel is employed to deliver longitudinal motion to an axial drive member and a tissue cutting knife as is known in the art.
• The axial drive member or an axial drive screw contacts pusher elements. The pusher elements drive the staples through the body tissue against the fastener or forming surface of the anvil as discussed herein. Typically, in the art thesurgical stapler10 fires usually by an actuation of a first trigger handle or alternatively using atrigger switch26. Thereafter, the clamping action of thejaws21,22 is released and thesurgical stapler10 or a portion thereof may be withdrawn from the body.
• Referring now toFIG. 2, there is shown a block diagram of thesurgical stapler10 of the present disclosure. According to a first aspect of the present disclosure, thesurgical stapler10 may have anoptional controller28. Thecontroller28 is any electronic device being coupled to a memory for executing one or more readable program instructions or alternatively may be a suitable analog circuit. Still further, thecontroller28 may be a suitable mechanical member or linkage for controlling one or more functions of thesurgical stapler10.
• Thecontroller28 is connected to an internal or external power supply and a motor and is connected between theanvil22 and the staplingcartridge21. In an alternative embodiment, a trigger handle or another actuating switch orcomponent26 is mechanically or electronically linked or otherwise connected to the staplingcartridge21 as is known in the art as indicated by a dotted line, and the present disclosure is not intended to be limited to any configuration. Once the staplingcartridge21 is fired using thetrigger switch26, thejaws21,22 are opened and the firing mechanism is retracted. Thesurgical stapler10 as a whole may be withdrawn from the body tissue or may be manipulated for a next or second stapling operation as shown.
• The presentsurgical stapler10 has thecontroller28 which is connected to one of the jaw oranvil21 or jaw orstaple cartridge21 and thetrigger switch26 or is connected to bothjaws21,22 and thetrigger switch26. In one embodiment, once the desired site is reached, the surgeon uses thejaws21,22 to compress the selected body tissue. Alternatively, thesurgical stapler10 may have a single drive component that can actuate both theanvil22 and staplingcartridge21.
• Thereafter, thecontroller28 may provide for a requisite amount of delay between clamping and firing (or after clamping and before firing) to ensure tissue compression and expulsion of fluid. After the desired compression is reached, the staplingcartridge21 may be automatically engaged by thecontroller28 to fire the staples from the staplingcartridge21 into the body tissue or alternatively thecontroller28 may send a signal to the surgeon thereby informing the surgeon a suggestion that the surgeon is to fire the staples. It is envisioned that the firing may be automatic or manual.
• Furthermore, thecontroller28 may control the speed with which the staples are fired from thestaple cartridge21. Still further, thecontroller28 may control an amount of delay before firing. Thecontroller28 in one embodiment may provide for a predetermined amount of time to elapse prior to outputting a signal to the staplingcartridge21. In another powered stapler embodiment, thecontroller28 may slow a motor speed to increase the body tissue compression time.
• In still another embodiment, thecontroller28 may engage a dampeningdevice30. The dampeningdevice30 is configured to slow the actuating of thestaple cartridge21 in order to increase the overall compression time of the body tissue. Such a dampeningdevice30 may be a hydraulic or a pneumatic type damper or any other device that may dampen or modulate the operation of one or more components of thesurgical stapler10. In another embodiment, thetrigger26 may simply hold the fire signal for a predetermined time period in associated control circuitry and upon the expiration of the predetermined time period may communicate the signal to the staplingcartridge21.
• Thecontroller28 may be configured to slow a motor speed, modulate a gear or, still further, engage a circuitry of the motor to slow an operation thereof to otherwise reduce actuation, i.e., a rotation rate of the axial drive screw. Still further, thesurgical stapler10 may also include an override switch32. The override switch32 is an automatic or manual device (or other switch) that selectively disengages thecontroller28 to permit direct actuation of the staplingcartridge21 by thetrigger switch26 without any delay at the surgeon's discretion.
• In one aspect of the present disclosure, the presentsurgical stapler10 includesjaws21,22 which compresses tissue between theanvil130 and thestapler cartridge132 of the stapling cartridge21 (FIG. 2B). Thejaws21,22 are understood in the art as a device that allows the surgeon to manipulate and compress tissue between theanvil130 and thestaple cartridge132 prior to urging of thestaples158 from thestaple cartridge132 as shown inFIG. 2B. Thejaws21,22 may be independently powered by a power source such as a motor or pneumatic device, or may be powered by the same power source as thestaple cartridge21. Thesurgical stapler10 uses thejaws21,22 to clamp tissue between thestapler cartridge132 and the anvil130 (FIG. 2b), then when thestapler10 is fired thejaws21,22 may be further tightened and then thestaples158 urged from the staplingcartridge21.
• In one aspect, thesurgical stapler10 may pre-clamp or compress tissue using thejaws21,22 for a first interval. The first time interval may be preset and fixed, or variable depending on the tissue type. The first time interval may be for minutes, seconds or any other variable or fixed predetermined period of time. Then prior to stapling, thejaws21,22 may further tighten to further compress the tissue for another second compression time interval and then fire. The second time interval may be different from the first time interval and can be shorter or longer than the first. In another aspect, the instrument may pre-clamp or compress tissue using thejaws21,22 and then simply automatically fire the device to urge thestaples158 from thestaple cartridge132 at the conclusion of the first interval. Various configurations are possible, and the presentsurgical stapler10 may have program instructions for any number of compression intervals desired by the surgeon and/or designer. Thesurgical stapler10 may alternatively further use a second separate clamping device in association with thestapler10. It is understood that the present disclosure may be incorporated into an instrument that approximates the tissue before firing such as with a TA surgical stapler such as U.S. Pat. No. 6,817,508 to Racenet, et al. which is herein incorporated by reference in its entirety, or can be used with an instrument that requires no such approximation before firing.
• In another embodiment of the present disclosure, thesurgical stapling device10 may provide the surgeon with feedback by virtue of anindicator36. Theindicator36 may display an amount of compression time and/or provide feedback of the status of the stapling, or display information relating to the location of the drive screw, or drive member. In another embodiment of the present disclosure, thesurgical stapler10 may not have separate clamping and firing actuators and include a clampinggradient indicator36 or simultaneous clamping and firing indication mechanism. For example, thesurgical stapler10 may be configured to allow control of the firing speed which, in turn, controls the clamping speed and timing and then provide optimal compression for squeezing the tissue and pushing the blood and fluid out of the tissue at the desired site.
• FIG. 2A shows an exploded view of a number of components of thesurgical stapler10 ofFIG. 1. Thestapler10 has arack100 that is slidable in thehandle portion14. Therack100 interfaces with aclamp tube102. On a distal side of theclamp tube102 is achannel104. Thechannel104 engages with theclamp tube102 and a pair offorks106,108 on a distal side thereof. Thestapler10 also has anupper cover110 and alower cover112, and anextension tube114. Theextension tube114 engages with acollar tube116. Thestapler10 also has arotation knob118 with achannel portion120. Thechannel portion120 has a pair of camming surfaces122 on a distal end. The distal end also has acrimp124 in a distal side to receive theanvil22.
• In operation, therack100 slides and moves theclamp tube102 distally. Thedamp tube102 is provided to interconnect thehandle portion14 and theextension tube114. Thechannel104 is slidably mounted for reciprocal longitudinal motion. Theextension tube114 provides support for thesurgical stapler10 and has slots that interface with thecollar tube116. Thesurgical stapler10 also has asupport120 for longitudinal motion and to operate the stapling mechanism as described inFIG. 2b. The operation of these components is well known and is disclosed in U.S. Pat. No. 5,318,221 to Green, et al., which is herein incorporated by reference in its entirety.
• Advantageously, therack100 moves distally to advance thechannel104 in a distal manner. Thechannel104 delivers longitudinal motion to a pusher cam bar as is known in the art for operation of thestapler cartridge21 shown inFIG. 2b. It should be appreciated that the components shown inFIG. 2aonly illustrate one embodiment of the presentsurgical stapler10, and instead of therack100, thesurgical stapler10 may have a drive screw (not shown) for longitudinal motion and in order to actuate thestapler cartridge21. Referring now toFIG. 2b, there is shown an exploded view of theanvil22 and thestapler cartridge132 having an actuation sled169.
• Referring toFIG. 2b, thestapler cartridge21 includes ananvil assembly130 and acartridge assembly132 shown in an exploded view for illustration purposes. Theanvil assembly130 includesanvil portion22 having a plurality of staple deforming concavities (not shown) and acover plate136 secured to a top surface of anvil portion134 to define a cavity (not shown). Thecover plate136 prevents pinching of tissue during clamping and firing of thesurgical stapler10. The cavity is dimensioned to receive a distal end of anaxial drive assembly138.
• Theanvil130 has alongitudinal slot140 that extends throughanvil portion130 to facilitate passage ofretention flange142 of theaxial drive assembly138 into theanvil slot140. Acamming surface144 formed onanvil22 is positioned to engageaxial drive assembly138 to facilitate clamping of tissue. A pair ofpivot members146 formed onanvil portion130 is positioned withinslots146′ formed incarrier148 to guide theanvil portion130 between the open and clamped positions.
• Thestapler10 has a pair of stabilizing members152 engage a respective shoulder formed oncarrier148 to preventanvil portion30 from sliding axially relative tostaple cartridge132 as camming surface of theanvil130 is deformed.Cartridge assembly132 includes thecarrier148 which defines anelongated support channel154.Elongated support channel154 is dimensioned and configured to receive thestaple cartridge132 which is shown above thecarrier148 in the exploded view ofFIG. 2b. Corresponding tabs and slots formed alongstaple cartridge132 andelongated support channel148′ function to retainstaple cartridge132 withinsupport channel154 ofcarrier148. A pair of support struts formed on thestaple cartridge132 are positioned to rest on side walls ofcarrier148 to further stabilizestaple cartridge132 withinsupport channel154, however other arrangements to support thecartridge132 on thechannel154 can be used and this arrangement is not limiting.
• Staple cartridge132 includesretention slots156 for receiving a plurality offasteners158 andpushers160.Longitudinal slots156 extend throughstaple cartridge132 to accommodateupstanding cam wedges162 of theactuation sled164. A centrallongitudinal slot166 extends along the length ofstaple cartridge132 to facilitate passage of a knife blade (not shown). During operation ofsurgical stapler10,actuation sled164 is drive distally to translate throughlongitudinal slot156 ofstaple cartridge132 and to advancecam wedges162 distally and into sequential contact withpushers160, to causepushers160 to translate vertically withinslots156 andurge fasteners158 fromslots156 into the staple deforming cavities ofanvil assembly130 to effect the stapling of tissue.
• Referring toFIG. 3, thesurgical stapler10 may includeindicator36 which may be any device known in the art to provide sensory feedback to the surgeon. Theindicator36 may be any device that permits a visual, tactile or audible monitoring of one or more conditions of thesurgical stapler10. Theindicator36 may be disposed onouter surface34 and disposed on thehandle14. Alternatively, theindicator36 may be disposed onportion16, on thetrigger switch26, on thelever24 or in any other suitable location where theindicator36 may be easily viewed by the surgeon without a change in position of change in footing by the surgeon.
• In one embodiment, as shown theindicator36 includes a number oflight bulbs38. Thelights38 may be one light or a series of many lights bulbs or LEDs with one color or an assortment of two or more colors. Each of thelights38 may have a color representing one or more conditions of thesurgical stapler10. Alternatively, one or all of thelights36 may flash to indicate a condition of thesurgical stapler10.
• Upon being actuated by thetrigger switch26, thesurgical stapler10 may impart a delay before firing of the staples. However, in order to provide the proper feedback to the surgeon, thelights38 provide, for example, a visual indication of the progress of the firing of the staplingcartridge21. For example, still referring toFIG. 3, there is shown afirst light40, asecond light42, athird light44, afourth light46, and afifth light48. As the axial drive screw (not shown and in the handle) travels the predetermined drive path thelights40,42,44,46, and48 illuminate in series to portray the relative distance of the drive screw on the exterior of the handle. When thelights40,42,44,46, and48 are illuminated, the staplingcartridge21 fires which ensures that proper tissue compression occurs prior to deployment of the staples.
• Referring now toFIG. 4, in another exemplary embodiment of the present disclosure, thesurgical stapler10 includes alinear indicator50 having a plurality of discrete segments,first segment52,second segment54,third segment56,fourth segment58, andfifth segment60. Again, once thetrigger switch26 is actuated to fire the staplingcartridge21, thesegments52,54,56,58, and60 each illuminate in a predetermined pattern to indicate to the surgeon the status of the progression of the drive screw in thehandle14.
• Upon all of thesegments52,54,56,58, and60 being illuminated, the staplingcartridge21 fires the staple into the body tissue with assurance that an amount of compression time of the body tissue has lapsed.Linear display50 may have one or more different colors or combinations of colors to indicate a position of the drive screw such as “red” to indicate firing and “green” to indicate that the firing is complete or vice versa. Still further thelinear display50 may display one or more graphical representations, images, or pictures to indicate one or more conditions or operating parameters of thesurgical stapler10.
• For example, thelinear display50 may indicate “FIRE” or “COMPLETE”, or any other graphical representation to indicate thatsurgical stapler10 will fire at the predetermined time period. Various possible combinations are possible and all are within the scope of the present disclosure.
• In still another exemplary embodiment of the present disclosure shown inFIG. 5, thesurgical stapler10 may include adigital display62. Thedigital display62 may indicate a count down or count up (or other time interval) after actuation of thetrigger switch26. For example, thedigital display62 may count down to the desired stapling time after compression to ensure a predetermined amount of tissue compression by thejaws21,22. Thedigital display62 may be activated by thejaws21,22 being brought in close alignment with one another or activated independent of clamping. A desired clamping interval may be preset for desired tissue.
• Alternatively, thedigital display62 may be selectively preset and input by the surgeon using an input device (not shown) or button. The surgeon may input a time period of clamping into thedisplay62. Thereafter, thedisplay62 will suggest firing at the elapse of the clamping time period, or may automatically fire after a predetermined clamping time elapses (e.g., such as from about ten seconds to forty five seconds) to ensure proper tissue compression. Thedigital display62 may be configured to count down from the predetermined set interval of clamping and visually communicate a signal to thecontroller28. Thecontroller28 after receiving the signal allows the to desired time period of clamping to elapse. After the set time period expires, thecontroller28 may communicate a second signal to actuate the staplingcartridge21. Alternatively, thecontroller28 may simply modulate the speed of the motor to commence operation at a speed suitable to actuate the staplingcartridge21 at the end of the desired time period. In still yet another embodiment, thedigital display62 may be configured to initiate counting after commencement of the clamping of tissue and then simply display the time from that point onwards to allow the surgeon to monitor and manually actuate thetrigger switch26 at the expiration of the desired time period. Thereafter, thedigital display62 may simply display or flash the compression time to the surgeon and the exact amount of elapsed time. It is appreciated that the instrument may provide a predetermined delay and then indicate that the instrument is ready to be manually fired, or alternatively the instrument may delay then indicate and then automatically fire.
• Referring now toFIG. 6, thesurgical stapler10 may alternatively have ananalog display64 disposed on the outer surface of thehandle14 which functions similar to thedigital display62.Analog display64 may have an audible alarm or alternatively have a flashing light to indicate that the appropriate tissue compression time has been reached or exceeded.
• Referring now toFIG. 7, there is shown a cross sectional view of thehandle12 of the surgical stapler along line7-7 ofFIG. 3. In this embodiment, thesurgical stapler10 is a powered device and has amotor66 with a driving mechanism. The driving mechanism is adrive output shaft68.Shaft68 connects to afirst gear70. Thefirst gear70 is connected to asecond gear72 which, in turn, engages anaxial drive screw74. Themotor66 may be a device that drives one or more components of thesurgical stapler10.
• Thedrive screw74 is a threaded rod having a number of helical grooves that are intended to rotate and contact another member to actuate the staplingcartridge21 in the distal location of thesurgical stapler10 once compression is made by the surgeon using the clamp orjaws21,22. Theaxial drive screw74 is disposed in toothed engagement through acentral bore76 of thesecond gear72. The axial drive screw may also be disposed offset from thesecond gear72 or in any other desired geared arrangement. Upon actuation of themotor66, theaxial drive screw74 rotates and traverses distally through theportion16 of thesurgical stapler10 to engage thestapler cartridge21 as is well known in the art. Alternatively, thesurgical stapler10 may have a drive piston or plunger instead of theaxial drive screw74 or a single drive mechanism to control both theanvil22 and the staplingcartridge21. Such mechanisms are well known in the art and may be found in U.S. Pat. No. 6,330,965 B1 to Milliman, et al., U.S. Pat. No. 6,250,532 B1 to Green, et al., U.S. Pat. No. 6,241,139 B1 to Milliman, et al., U.S. Pat. No. 6,109,500 to Alli et al., U.S. Pat. No. 6,202,914 B1 to Geiste, et al. U.S. Pat. No. 6,032,849 to Mastri, et al. and U.S. Pat. No. 5,954,259 to Viola, et al., which are all herein incorporated by reference in their entirety.
• Thesurgical stapler10 may include afirst switch80.Switch80 is located in a fixed position of the handle as shown. Thestapler10 also has asecond switch82 disposed distally relative to thefirst switch80 that is distal or near the path of thedrive screw74 in the firstinitial position78. Likewise, thesecond switch82 in asecond firing position84 which is disposed distally from the first initial position and proximal or near the path of thedrive screw74. Each of the first andsecond switches80,82 is a limit switch, but alternatively may be any switch known in the art to change or toggle from a first position to a second position by a simple motion of theaxial drive screw74 traversing past or adjacent to the respective limit switch.
• Once theaxial drive screw74 or a portion thereof traverses past thefirst switch80, the first switch communicates a signal to thecontroller28 bylead86. Thecontroller28 thus illuminates theindicator36 or a portion thereof bylead88 to indicate to the surgeon a first location of theaxial drive screw74.
• Thereafter, thedrive screw74 or a portion thereof traverses or contacts thesecond switch82 at thesecond firing position84. Thesecond switch82 is also a limit switch and communicates a second signal to thecontroller28 bylead90 of the location or firing of thestapler cartridge21. Thecontroller28 then illuminates indicator36 (or another portion thereof) bylead88 to indicate to the surgeon that the stapling has been completed. At the conclusion of the stapling, the surgeon/operator will initiate retraction and then will reverse a direction of themotor66 bylead92. Themotor66 then reverses operation and returns theaxial drive screw74 to theinitial position78 for the next stapling operation.
• Alternatively,controller28 upon receiving the first signal from thefirst switch80 bylead86 modulates one or more operations of thesurgical stapler10. For example, in response to receiving of the first signal, thecontroller28 can control one or more parameters of thesurgical stapler10 including tissue gap, speed of themotor66, control stroke of theaxial drive screw74, axial drive screw travel distance, rotational rate of the axial drive screw and any combinations thereof.
• Referring now toFIG. 8, the surgeon may operate/engage the firing mechanism in order to actuate the staplingcartridge21. The firing mechanism actuates themotor66 shown inFIG. 8. Theaxial drive screw74 commences rotation and by traversingpast switch80 thedrive screw74 actuates thefirst switch80. Thefirst switch80 outputs the signal to thecontroller28 bylead86. Thecontroller28 in response to the signal from thefirst switch80 then actuates thefirst light40 bylead92. Thesurgical stapler10 may further have a suitable structure in order to engage a stop feature. The stop feature prohibits overdrive of thedrive screw74. Thereafter, after theaxial drive screw74 traverses a predetermined distance to ensure tissue compression by the clamp orjaws21,22. Thesecond switch82 is actuated and outputs a second signal to thecontroller28 bylead90. Thecontroller28 in response to the second signal illuminates thesecond light42 by lead94. Thesecond light42 indicates that the staplingcartridge21 has fired. Thesecond switch82 may further emit a signal to thecontroller28 to reverse or cease motion in that direction of themotor66 or to return theaxial drive screw74 to the initial position. The physician/operator may also manually reverse the direction of themotor66. Athird light44 may illuminate to indicate to the surgeon that theaxial drive screw74 is returning to theinitial position78.
• FIG. 8A illustrates another embodiment of the present stapler. In the embodiment shown, the surgeon may operate/engage the firing mechanism in order to actuate the staplingcartridge21. However, thefirst switch80′ is in a different location than the embodiment shown inFIG. 8. In this embodiment thefirst switch80′ is located immediately under thelever24 proximal to handle14. Theswitch80′ in the embodiment ofFIG. 8A engages atab24′ disposed on thelever24. When thelever24 is actuated and driven toward thehandle14, thetab24′ contacts switch80′, and theswitch80′ outputs the signal to thecontroller28 bylead86. Thecontroller28 in response to the signal from thefirst switch80 then actuates thefirst light40 bylead92.
• Thereafter, after theaxial drive screw74 traverses a predetermined distance to ensure tissue compression by the clamp orjaws21,22, thesecond switch82 is actuated and outputs a second signal to thecontroller28 bylead90. Again, thecontroller28 in response to the second signal illuminates thesecond light42 by lead94. Thesecond light42 indicates that the staplingcartridge21 has fired. Thesecond switch82 that is actuated byswitch80′ may further emit a signal to thecontroller28 to reverse or cease motion in that direction of themotor66 or to return theaxial drive screw74 to the initial position. Athird indicator44 may be included to indicate to the surgeon that theaxial drive screw74 is returning to theinitial position78.
• FIG. 8B shows still another embodiment wherein thefirst switch80″ is located at still another location of thehandle14, and on an opposite distal side of thelever24 in proximity to pivot Various configurations are possible and within the scope of the present disclosure, and switch80″ may be placed in various configurations relative to thelever24.
• FIG. 9 shows thesurgical stapler10 with alever24. Thelever24, shown in the elevated position, controls the clamp orjaws21,22, however this arrangement is not limiting and another driving member may control the clamp orjaws21,22 such as the motor66 (FIG. 7). Thelever24 opens and closes thejaws21,22 of the clamp to compress the body tissue prior to surgical stapling. Thesurgical stapler10 further includes anelectrical contact96 with an electrically conductive member to complete a suitable analog or digital circuit. Theelectrical contact96 is in a complementary nesting location of thelever24 when the lever is in a lowered position or mating with thehandle14. When thelever24 is lowered from an elevated or raised position to the lowered position or contacting thehandle14, thelever24 engages theelectrical contact96. The electrical contact may complete a suitable timer circuit of thedisplay62 when in the lowered position. In this embodiment, theelectrical contact96 commences thedisplay62. Thedisplay62 may count upwards from zero to a predetermined time limit, or may count down from an ideal predetermined tissue compression time interval. Once the displayed time reaches the predetermined time interval, anaudible alarm98 may sound. Theaudible alarm98 provides the surgeon with a cue that the optimal tissue compression time has been reached, and that the firing mechanism should be actuated in order to fire the staple from thestaple cartridge21 to ensure a uniform staple formation.
• FIG. 10 illustrates in still another embodiment where the clamp formed byjaws21,22 is actuated by lowering thelever24. Contemporaneously, the timer circuit of thedisplay62 is activated by theelectrical contact96 on thelever24. Theindicator36 may be thelinear display50 which indicates a first color to prompt for the actuation of thestapling mechanism21 by the trigger switch orbutton26. Thedisplay50 may then display a second image or illuminate the number of segments corresponding to a travel path of theaxial drive screw74 as shown inFIG. 7. Upon actuation, thesecond switch82 outputs a signal to thecontroller28. Thecontroller28 then stops themotor66, and the controller outputs a control signal to thedisplay50 to modulate the display from the first color to another second color or from a first image to a second image to indicate that the staplingcartridge21 has fired. Optionally, thecontroller28 may further sound theaudible alarm98 indicating that the staplingcartridge21 has fired. The alarm may be any sound or audible pattern, including a buzzer, a song, a chirp, a chime or any combinations thereof. Various indicator configurations are possible and within the scope of the present disclosure.
• In still another embodiment, thejaws21,22 may be actuated by lowering thelever24. Contemporaneously, the timer circuit of thedisplay62 is activated by thelever24. Thereafter, theindicator36 indicates a first indication to prompt for an actuation of the staplingcartridge21 by actuatingswitch26 after a desired time period elapses. Once thetrigger switch26 is actuated, thecontroller28 activates themotor30. Themotor30 then moves thedrive screw74 as shown inFIG. 7.
• As theaxial drive screw74 moves in an axial manner, the drive screw (or anotherplunger100 connected thereto as shown inFIG. 11) contacts asecond member102.Second member102 may be any member that modulates based on the motion of theplunger100 and that can be detected or sensed by another device to provide an indication to the surgeon. Thesecond member102 may be a resistor strip which changes a resistance along atravel surface104 of theplunger100 as theplunger100 or theaxial drive screw74 traverses along theportion16 of the surgical stapler10 (or other suitable travel surface location). Theresistor strip102 is coupled toindicator36 such that the change in resistance of theresistor strip102 selectively illuminates each of thelights40 through48 to signal an amount of travel by theaxial drive screw74 or theplunger100 or other suitable drive member.
• Alternatively, theresistor strip102 may be coupled to anotherindicator36 such as alinear display50. Thedisplay50 may illuminate the number ofsegments52,54,56,58, and60 corresponding to a travel of theaxial drive screw74 or theplunger100 until the axial drive screw actuates thestapler cartridge21. Upon actuated, theresistor strip102 outputs a signal to thecontroller28 which modulates the operation of themotor66, and sends another second signal to thedisplay50 to indicate that the staplingcartridge21 has fired. Thedisplay50 in response thereto may then display a suitable graphical image, another color, a textual message, or any other indication to indicate to the surgeon that the firing of the staplingcartridge21 has concluded. Various indicator configurations are possible and within the scope of the present disclosure.
• Referring now toFIG. 12, in yet another embodiment of the present disclosure, thesurgical stapler10 may further include anon-contact sensor106. Thenon-contact sensor106 may optionally be a so-called “Hall effect non-contact sensor” (or alternatively any other non-contact sensor) that is based in part on the physical principle of the Hall effect named after its discoverer E. H. Hall.
• For example, end108 of theaxial screw74 is directly connected, geared to, or offset from themotor74, and a cap likefree end110 ofaxial screw74 contacts thestapler cartridge21 to actuate the stapler cartridge and to fire the staple as discussed previously. Thefree end110 of thedrive screw74 has amagnetic member112 which connects thereto and which will not become dislodged by a rotation of thedrive screw74. Alternatively, themagnetic member112 may be disc shaped and simply connect to thefree end110. In one initial orientation,free end110 and themagnetic member112 are disposed closely adjacent, or near to thenon-contact sensor106. At this initial orientation, themagnetic member112 is separated by a first distance “d” from thenon-contact sensor106.
• Once the trigger switch orbutton26 is actuated, themotor66 is actuated, and rotates, the driveaxial screw74 to traverse distally to actuate thestapler cartridge21 as described above. In the second orientation after themotor66 has been actuated, themagnetic member112 moves and is a second distance “d” away from thenon-contact sensor106. The second distance is any distance greater than the first distance “d”. As themagnetic member112 moves away from thenon-contact sensor106, the non-contact sensor now located the second distance away from the magnetic field of themagnetic member112 modulates an operation of themotor66.
• The term “modulation” is defined as modulating amount of voltage received by themotor66 in a dynamic manner, turning the motor “off” at a desired stroke, changing the motor speed, drive gear reduction of the motor, reduction of the axial drive screw pitch, or a change in the voltage or the current input of the motor, or changing another firing component, a change of the motor components and any combinations thereof. This may thereby slow the operation of themotor66 to increase an amount of compression time of the body tissues betweenjaws21,22. In another alternative embodiment, themagnetic member112 may be disposed on a suitable drive piston instead of thedrive screw66. As the drive piston travels away from thenon-contact sensor106, a reduced or modulated amount of voltage may be provided to themotor66. Still further in another alternative embodiment, thenon-contact sensor106 may be placed at thefree end110 of thedrive screw74 and themagnetic member112 fixed.
• In another embodiment of the present disclosure, the surgical stapler may have a combined drive mechanism. The combined drive mechanism may control both a firing component of the stapling mechanism and a clamping mechanism. Thesurgical stapler10 may, upon being actuated, has the drive mechanism advance to commence the clamping using the clamping mechanism and then hold and wait thus providing a predetermined delay. Thesurgical stapler10 would then provide an indication to the surgeon/operator once a desired amount of compression is reached. Thereafter, the surgeon/operator would then actuate the drive mechanism after the time delay. The drive mechanism would then fire the staples from the staplingcartridge21 into the compressed tissues and thus ensure a uniform staple formation. Thesurgical stapler10 thus provides a time delay prior to stapling to ensure tissue compression.
• Although being shown as an endoscopic surgical stapler, the present drive system may be used with any surgical stapling device known in the art, such as endoscopic surgical stapling devices, a pulmonary stapling device, a GIA surgical stapling devices, an endo-GIA stapling device, a TA surgical stapling device and any other stapler device for surgery know in the art. The present disclosure may also be used with a single drive surgical stapler that drives both the clamp and the stapling device. The present disclosure may be incorporated into a device that approximates and then fires such as with a TA surgical stapling device or with a surgical stapler without any such approximation of tissue.
• It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.

Claims (7)

1-35. (canceled)

36. A surgical stapler comprising:

a handle assembly including a trigger;

a clamping device having a staple cartridge containing a plurality of staples and an anvil having a fastener forming surface thereon; and

a controller configured to determine an occurrence of clamping by the anvil and the staple cartridge, the controller controlling firing of the plurality of staples from the staple cartridge;

wherein when the trigger is actuated the controller delays firing of the plurality of staples from the staple cartridge to provide for a predetermined time period of tissue compression of the tissue between the anvil and staple cartridge and wherein the controller outputs a control signal to allow firing once the predetermined time period is reached.

37. The surgical stapler ofclaim 36, wherein the controller is operatively connected to a drive member to urge the plurality of staples from the staple cartridge.

38. The surgical stapler ofclaim 36, wherein the controller is operatively connected to a motor to urge the plurality of staples from the staple cartridge.

39. The surgical stapler ofclaim 36, wherein the staples are fired automatically after the predetermined time period.

40. The surgical stapler ofclaim 36, wherein the staples are fired manually after the predetermined time period.

41. The surgical stapler ofclaim 36, further comprising an indicator connected to the controller, the indicator indicating a signal to the surgeon after the predetermined time period.

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