Powered surgical stapler with automated pre-fire mechanical lockout verification

Abstract

A powered or robotic surgical stapler includes a housing with an integrated motor, a removable cartridge assembly containing staples, an anvil assembly for staple deformation, and a lockout mechanism which may be disposed in the cartridge or a loading unit including the same. The stapler further incorporates a drive assembly connected to the motor, a sensor to measure motor or drive assembly parameters, and a processor for operational management. The processor executes an interlock verification process, moving the drive assembly to specific positions to assess the lockout mechanism's status, whether a staple ejecting sled is missing, or the cartridge has been fired, based on sensor data. Depending on the lockout mechanism's state, the processor enables or disables the firing process to eject staples.

Description

POWERED SURGICAL STAPLER WITH AUTOMATEDPRE-FIRE MECHANICAL LOCKOUT VERIFICATIONCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No.63 / 711,858, filed October 25, 2024, which is incorporated herein by reference in its entirety.BACKGROUND1. Technical Field

[0002] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to electromechanical surgical systems for performing stapling surgical procedures and for automated pre-fire mechanical lockout verification in a surgical stapler cartridge or loading unit (e.g., reload).2. Background of Related Art

[0003] Surgical stapling devices configured for endoscopic use are commonly used during surgical procedures to minimize patient trauma and reduce patient recovery times. Typically, endoscopic stapling devices include a tool assembly and a drive assembly that is movable in relation to the tool assembly to actuate the tool assembly. The tool assembly includes an anvil and a cartridge assembly that are coupled to each other by a pivot member and movable in relation to each other between unclamped and clamped positions in response to movement of the drive assembly from a retracted position to an advanced position. The cartridge assembly includes a staple cartridge that includes a cartridge body that supports staples and an actuation sled that is movable through the cartridge body in response to movement of the drive assembly from the retracted position to the advanced position to eject the staples from the cartridge body. The drive assembly or the actuation sled supports a knife or cutting blade that cuts tissue clamped between the anvil and the cartridge assembly as the drive assembly moves from the retracted position to the advanced position.

[0004] Some stapling devices include a staple cartridge that can be replaced after each firing of the stapling device to facilitate reuse of the stapling device. To ensure that a stapling device is not fired with a spent staple cartridge, i.e., a staple cartridge having no staples, or without a staple cartridge or necessary components of the staple cartridge, some stapling devices include lockouts to prevent firing of the stapling device unless an operable staple cartridge is present in the cartridgeassembly. A continuing need exists for a surgical stapling device having a cost-effective assembly for preventing firing of the stapling device when an operable staple cartridge is not present in the cartridge assembly.SUMMARY

[0005] The lockout verification system and method according to the present disclosure may be used in a variety of intelligent, powered surgical stapler devices, such as handheld powered staplers and robotically controlled staplers. Additionally, the lockout verification system may be used with stapler cartridges or loading units (e.g., reloads which, in addition to a stapler cartridge, also include other stapling components, such as an anvil, drive shaft, etc.). The stapler cartridges and loading units include a stapler pusher or sled for ejecting staples and a lockout mechanism for locking out the stapler if the sled is missing or fired. The lockout mechanism may be resettable, namely, locked out when there is something (e.g., sled) not present but functional when it is.

[0006] Certain powered surgical staplers are capable of detecting whether the reload has been previously fired and in response thereto are prevented from activating staple firing drive mechanism. Once the lockout within the reload is triggered, the device becomes unusable. Certain reloads use a lockout design that is only detectable on a subsequent firing (i.e., to determine if the reload has already been used). Thus, whether the lockout has been engaged cannot be detected on the initial attempt.

[0007] The lockout detection algorithm according to the present disclosure is directed to verifying lockout mechanisms that actuate when a sled is missing such that the stapler is not capable of firing on the initial attempt. The algorithm may be embodied as software instructions stored in memory and executable by a processor. The algorithm may be executed autonomously, which may be done at the earliest possible opportunity, which, for a cartridge-based system, may occur when the cartridge is attached, and for a reload-based system, when the reload is attached. The algorithm may be used to verify the state of any lockout design that can be detected on an initial firing attempt.

[0008] A powered surgical stapling device, which may be a handheld or a robotic device, is disclosed and includes a tool assembly including an anvil assembly, a cartridge assembly, and a drive assembly. The tool assembly may have a removable stapler cartridge or may be a loading unit, each of which supports a lockout mechanism for locking out the device if a sled is missing or fired. The term “powered” is used to generally refer to any motor-actuated mechanism foractuating the tool assembly. The cartridge assembly includes a deployable knife that is movable from a lowered position to a raised position in response to movement of the drive assembly from a drive retracted position towards a drive advanced position. The tool assembly supports a lockout mechanism that is movable from a locked position (i.e., interlock) to an unlocked position in response to advancement of the drive assembly from the drive retracted position towards the drive advanced position when an operable staple cartridge is received in a channel member of the cartridge assembly. As used herein, the term operable staple cartridge is used generally to refer to a staple cartridge that includes staples and an actuation sled and / or a knife to effectively treat tissue.

[0009] Current surgical stapling devices often detect a lockout condition only after the firing process has been initiated. In such devices, the surgeon may press the firing button, expecting the stapler to function, only to encounter an error mid-procedure when the lockout is triggered. This delayed detection can cause confusion for the surgeon, result in unnecessary delays, and extend surgery times, as the system does not prevent the initial attempt to fire a spent or improperly loaded cartridge.

[0010] The present disclosure provides an automated pre-fire lockout detection system that identifies potential issues, such as a missing or fired sled, at the earliest possible time — before the firing button is pressed. For a cartridge- based system, this verification occurs as soon as the cartridge is attached, and for a reload-based system, it happens when the reload is inserted. By performing lockout verification early, the system prevents the firing process from being initiated if a problem is detected, avoiding mid-procedure interruptions and enhancing the overall efficiency and safety of the surgical process. The ability to automatically detect lockout conditions before firing represents a significant improvement over existing systems by reducing errors and improving procedural workflow.

[0011] The powered surgical stapling device is configured to detect whether the staple cartridge or the loading unit was previously used. The detection is performed based on one or more motor parameters (e.g., current or torque) or a mechanical parameter (e.g., force or strain). These parameters are used to determine whether a mechanical hard stop is encountered before firing since the detected hard stop corresponds to the lockout mechanism being in the locked position (i.e., interlock). The verification may be performed automatically during attachment of reload or cartridge, during clamp test, or after safety button is pressed but before the firing process isinitiated, e.g., pressing of a firing button. As stated above, this verification was previously performed manually by a user when initiating the firing process, e.g., pressing a firing button. Detection of a mechanical hard stop before the firing process is indicative that the staple cartridge has a missing sled or whether the cartridge or the loading unit has already been fired. This detection is performed during a specific detection zone of a firing drive that is used to advance a sled and / or knife before initiating the firing process. The mechanical hard stop is a physical barrier detected by the system through motor or mechanical parameters, such as torque or force. When the system encounters this stop, it indicates that the lockout is engaged. The system compares the detected force in this zone to a predetermined interlock threshold, which is derived from the fully clamped position's parameters, to confirm whether the stapler can proceed with firing.

[0012] The present disclosure provides for automatic detection of interlock verification before firing has begun. The powered surgical stapling device includes a safety button that is pressed along with a fire button to initiate the firing sequence to prevent accidental firing by only engaging the fire button. Pressing the safety button initiates a checking process to ensure that the powered surgical stapling device is capable of firing before allowing the user to press the fire button, i.e., pressing of the fire button before the checking process is completed will not initiate firing. The checking process includes automatic detection of the interlock to verify whether the stapler cartridge was previously used (or essential element is missing, e.g., sled). During the detection process, the firing drive is advanced to the interlock detection zone, then retracts back to the fully clamped position. The interlock detection zone is the area where the firing drive advances during the checking process to determine if the lockout mechanism is engaged. This zone allows the system to verify whether the stapler cartridge has already been used or if a key component, like the sled, is missing. If a hard stop is detected in this zone, it indicates that the lockout mechanism is active, preventing the device from firing.

[0013] Detection of the mechanical hard stop during this process may be based on any of the motor or mechanical parameters described above. The specific thresholds for the mechanical hard stop indicative of the interlock may vary and may be based on other thresholds (e.g., threshold torque corresponding to a fully clamped position). The fully clamped position refers to the state where the anvil assembly and cartridge assembly are brought together to securely hold tissue between them, preparing the device for firing. This position is verified by the system using motor parameters, such as torque or strain, to confirm proper clamping of the tissue. The stapler mustreach this position before proceeding with the firing process. Thus, the interlock threshold may be setup as a difference from the fully clamped position threshold.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:

[0015] FIG. 1 is a side perspective view of a powered surgical stapling device with a tool assembly of the stapling device in an unclamped position, pre-fired position according to an embodiment of the present disclosure;

[0016] FIG. 2 is an enlarged view of the indicated area of detail shown in FIG. 1;

[0017] FIG. 3 is a side perspective, exploded view of the tool assembly of the stapling device shown in FIG. 1 ;

[0018] FIG. 4 is a schematic diagram of the surgical stapling device of FIG. 1 ;

[0019] FIG. 5 is a cross-sectional view taken along section line 5-5 of FIG. 2 showing the tool assembly in the pre-fired unclamped position;

[0020] FIG. 6 is an enlarged view of the indicated area of detail shown in FIG. 5;

[0021] FIG. 7 is a cross-sectional view of the proximal portion of the tool assembly with the tool assembly in a clamped, pre-fired position;

[0022] FIG. 8 is a cross-sectional view of the proximal portion of the tool assembly as a drive assembly of the stapling device moves from a drive clamped position towards a drive advanced position;

[0023] FIG. 9 is a cross-sectional view of the proximal portion of the tool assembly as the drive assembly of the stapling device moves from the drive advanced position back towards the drive retracted position;

[0024] FIG. 10 is a cross-sectional view of the proximal portion of the tool with the tool assembly in a post fired clamped position;

[0025] FIG. 11 is a schematic illustration of a surgical robotic system including a control tower, a console, and one or more surgical robotic arms each disposed on a movable cart according to an embodiment of the present disclosure;

[0026] FIG. 12 is a perspective view, with parts separated, of an instrument drive unit and a surgical instrument according to an embodiment of the present disclosure;

[0027] FIG. 13 is a perspective view of a surgical robotic stapler instrument in an unarticulated position according to an embodiment of the present disclosure;

[0028] FIG. 14 is an enlarged, perspective view of a loading unit of the surgical robotic stapler instrument of FIG. 13 in an unarticulated position; and

[0029] FIG. 15 is a flow chart of a method for automated pre-fire mechanical lockout verification according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF EMBODIMENTS

[0030] The disclosed powered surgical stapling device is described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that disclosed aspects of the surgical stapling device are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.

[0031] In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician during use of the device in its customary fashion, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician during use of the device in its customary fashion. In addition, directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure. Further, the terms “clinician” and “user” are used generally to refer to medical personnel including doctors, nurses, surgeons, and support personnel.

[0032] The disclosure is directed to a powered or robotic surgical stapling device that includes a tool assembly including an anvil assembly, a cartridge assembly, and a drive assembly. In embodiments, the entire tool assembly or the cartridge assembly may be replaceable. The cartridge assembly may include an optional deployable knife that is movable from a lowered position to a raised position in response to movement of the drive assembly from a drive retracted position towards a drive advanced position. In certain embodiments, the cartridge may only include staples and an actuation sled for ejecting the staples. The tool assembly supports a lockout mechanismthat is movable from a locked position to an unlocked position when an operable staple cartridge is received in a channel member of the cartridge assembly. As used herein, the term operable staple cartridge is used generally to refer to a staple cartridge that includes staples and an actuation sled and / or a knife to effectively treat tissue.

[0033] FIGS. 1 and 2 illustrate a powered surgical stapling device shown generally as stapler 10 that includes a housing (e.g., handle assembly) 12, a shaft (e.g., an elongated body) 14, and a tool assembly 16. The handle assembly 12 includes a stationary handgrip 18 and an actuation button or buttons 19. As shown in FIG. 4, the handle assembly 12 includes one or more motors, a battery, and control circuitry to drive the mechanisms of the stapler 10. A fire button 19 is disposed on the handle assembly 12 and is operable to activate the motor to actuate various functions of the tool assembly 16 via the elongated body 14, i.e., approximation of the tool assembly 16, and stapling and cutting of tissue. In addition, a safety button 21 is also disposed on the handle assembly 12 and is operable to initiate pre-fire mechanical lockout verification as described below.

[0034] The elongated body 14 of the stapler 10 defines a longitudinal axis “X” and includes a proximal portion 14a and a distal portion 14b. The proximal portion 14a of the elongated body 14 is coupled to the handle assembly 12, and the distal portion 14b of the elongated body 14 supports the tool assembly 16. In aspects of the disclosure, the tool assembly 16 is pivotably coupled to the distal portion 14b of the elongated body 14 to facilitate articulation of the tool assembly 16 in relation to the elongated body 14 about an articulation axis “Y”.

[0035] The tool assembly 16 includes an anvil assembly 20 and a cartridge assembly 22. In aspects of the disclosure, the cartridge assembly 22 is pivotably supported in relation to the anvil assembly 20 to facilitate movement of the tool assembly 16 between an unclamped position (FIG. 1) and a clamped position (FIG. 7). In some aspects of the disclosure, the tool assembly 16 includes a mounting assembly 24 that supports the anvil assembly 20 and the cartridge assembly 22 for movement between the unclamped position and the clamped position and for coupling the tool assembly 16 to the elongated body 14 for articulation about the articulation axis “Y”. In certain aspects of the disclosure, the anvil assembly 20 and the cartridge assembly 22 are coupled to the mounting assembly 24 by screws or pins 25 (FIG. 3). The mounting assembly 24 can be formed from mounting members 24a, 24b (FIG. 3) that are coupled together with rivets, screws, pins, adhesives, welding, or the like. In aspects of the disclosure, the mounting assembly 24 is fixedly coupled to the anvil assembly 20 and pivotably supports the cartridge assembly 22.

[0036] FIGS. 2 and 3 illustrate the cartridge assembly 22 which includes a channel member 26 and a staple cartridge 28. The channel member 26 includes side walls 30 and a bottom wall 32 that define a cavity 34. The staple cartridge 28 is removably received within the cavity 34 of the channel member 26 and is replaceable to facilitate reuse of the stapler 10 after each firing of the stapler 10 (FIG. 1). Each of the side walls 30 of the channel member 26 has an upper end that defines a recess 36. The bottom wall 32 of the channel member 26 includes an internal wall portion 32a and an outer wall portion 32b that define an internal channel 37 that extends from the proximal end of the channel member 26 towards the distal end of the channel member 26 along the longitudinal axis of the channel member 26. The inner wall portion of the bottom wall 32 defines an elongated slot (not shown) that communicates with the cavity 34 and the internal channel 37. The internal channel 37 and the elongate slot receive a portion of a drive assembly as described below.

[0037] The staple cartridge 28 includes a cartridge body 38 (FIG. 3), an actuation sled and knife assembly 40 having a knife 90 and a spring 82, staples 42, pushers 44, and a staple guard 46. The cartridge body 38 defines a knife slot 48 and staple receiving pockets 50 that are positioned on each side of the knife slot 48. In aspects of the disclosure, the staple receiving pockets 50 are aligned in two or more rows on opposite sides of the knife slot 48, and the knife slot 48 is longitudinally aligned with the elongate slot 37a in the channel member 26.

[0038] The cartridge body 38 includes laterally extending protrusions 51 (only one is shown) that are received within the recesses 36 (FIG. 2) of the channel member 26 to properly position the staple cartridge 28 within the cavity 34 of the channel member 26. The staples 42 and the pushers 44 are received within the staple receiving pockets 50 of the cartridge body 38, and the staple guard 46 is secured to the bottom of the cartridge body 38 to retain the staples 42 and pushers 44 within the cartridge body 38. The staple guard 46 also includes a bottom wall that defines an elongate slot 46a that is aligned with the elongate slots 37a and 48 defined in the cartridge body 38 and the channel member 26, respectively.

[0039] The actuation sled and knife assembly 40 is received within and is movable through the cartridge body 38 from a sled retracted position to a sled advanced position and includes an actuation sled 52 and a knife assembly 54. The actuation sled 52 includes angled inner and outer cam members 52a, 52b (FIG. 3) that have angled cam surfaces that are positioned to sequentially engage the pushers 44 as the actuation sled 52 moves through the cartridge body 38 from the sled retracted position towards the sled advanced position to lift the pushers 44 within the staplereceiving pockets 50 and eject the staples 42 from the cartridge body 38. The knife assembly 54 is supported on the actuation sled 52 as described below.

[0040] With reference to FIG. 4, the handle assembly 12 includes a main controller circuit board 142, a rechargeable battery 144 configured to supply power to any of the electrical components of handle assembly 12, and a plurality of motors, e.g., a first motor 152a, a second motor 152b, and a third motor 152c coupled to the battery 144. The handle assembly 12 also includes a display 146. In embodiments, the motors 152a, 152b, 152c may be coupled to any suitable power source configured to provide electrical energy to the motors 152a, 152b, 152c, such as an AC / DC transformer. Each of the motors 152a, 152b, 152c is coupled to a motor controller 143 which controls the operation of the corresponding motors 152a, 152b, 152c including the flow of electrical energy from the battery 144 to the motors 152a, 152b, 152c. A main controller 147 is provided that controls the handle assembly 12. The main controller 147 is configured to execute software instructions embodying algorithms, such as clamping, stapling, and cutting algorithms which control operation of the handle assembly 12.

[0041] The motor controller 143 includes a plurality of sensors 160a ... 160n configured to measure operational states of the motors 152a, 152b, 152c and the battery 144. The sensors 160a-160n include a strain gauge 160b and may also include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The strain gauge 160b may be disposed within the elongated body 14 or in contact with any other mechanical components of the stapler 10. The sensors 160a-160n may measure voltage, current, and other electrical properties of the electrical energy supplied by the battery 144. The sensors 160a-160n may also measure angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operational properties of the motors 152a, 152b, 152c. The sensor 160a also includes an encoder configured to count revolutions or other indicators of the motors 152a, 152b, 152c, which is then use by the main controller 147 to calculate linear movement of components movable by the motors 152a, 152b, 152c. Angular velocity may be determined by measuring the rotation of the motors 152a, 152b, 152c or a drive shaft (not shown) coupled thereto and rotatable by the motors 152a, 152b, 152c. The position of various axially movable drive shafts may also be determined by using various linear sensors disposed in or in proximity to the shafts or extrapolated from the RPM measurements. In embodiments, torque may be calculated based on the regulated current draw of the motors 152a, 152b, 152c at a constantRPM. In further embodiments, the motor controller 143 and / or the main controller 147 may measure time and process the above-described values as a function of time, including integration and / or differentiation, e.g., to determine the rate of change in the measured values. The main controller 147 is also configured to determine distance traveled of various components of the elongated body 14 and / or the tool assembly 16 by counting revolutions of the motors 152a, 152b, 152c.

[0042] The motor controller 143 is coupled to the main controller 147, which includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 147 receives measured sensor signals from the motor controller 143 regarding operational status of the motors 152a, 152b, 152c and the battery 144 and, in turn, outputs control signals to the motor controller 143 to control the operation of the motors 152a, 152b, 152c based on the sensor readings and specific algorithm instructions. The main controller 147 is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons 19 and 21, touch screen, etc.) coupled to the main controller 147.

[0043] The main controller 147 is also coupled to a memory 141. The memory 141 may include volatile (e.g., RAM) and non-volatile storage configured to store data, including software instructions for operating the handle assembly 12. The main controller 147 is also coupled to the strain gauge 160b using a wired or a wireless connection and is configured to receive strain measurements from the strain gauge 160b which are used during operation of the handle assembly 12.

[0044] The handle assembly 12 includes a plurality of motors 152a, 152b, 152c each including a respective motor shaft (not shown) extending therefrom and configured to drive a respective transmission assembly. Rotation of the motor shafts by the respective motors functions to drive shafts and / or gear components (not shown) of elongated body 14 in order to perform the various operations of handle assembly 12. In particular, motors 152a, 152b, 152c of handle assembly 12 are configured to drive shafts and / or gear components of elongated body 14 in order to actuate the tool assembly 16.

[0045] The handle assembly 12 may also include a communication interface 162 configured to connect to the interface device 104 using a wired (e.g., Firewire®, USB®, Serial RS232®, Serial RS485®, USART®, Ethernet®, etc.) or wireless (e.g., Bluetooth®, ANT3®, KNX®, ZWave®, X10® Wireless USB®, IrDA®, Nanonet®, Tiny OS®, ZigBee®, 802.11 IEEE, and other radio,infrared, UHF, VHF communications and the like) connection. The interface device 104 is configured to store the data transmitted thereto by the stapler 10 as well as process and analyze the data. The interface device 104 is also connected to other devices, such as the display 146.

[0046] FIGS. 5 and 6 illustrate the proximal portion of the tool assembly 16 with the tool assembly 16 in the unclamped position, the knife 90 in the non-deploy ed position, and the actuation sled and knife assembly 40 in the sled retracted position. When the knife 90 and the actuation sled and knife assembly 40 are in retracted positions, the lockout member 66 of the lockout mechanism 60 is positioned within the internal channel 37 of the channel member 26 by the biasing member 64 in a position to prevent advancement of the drive assembly 120.

[0047] FIGS. 7 and 8 illustrate the proximal portion of the tool assembly 16 as the drive assembly 120 moves from the drive clamped position towards the drive advanced position. When the drive assembly 120 moves from the drive clamped position towards the drive advanced position in the direction indicated by arrow “A”, the vertical strut 130 of the working member 124 of the drive assembly 124 engages the proximal portion 92 of the knife 90 to pivot the knife assembly 54 in the direction indicated by arrow “B” from the non-deployed position to the deployed position. In aspects of the disclosure, the cam surface 134 of the vertical strut 130 and the proximal portion 92 of the knife 90 may define curved engagement surfaces. When the knife 90 is in the deployed position, the proximal portion 92 of the knife 90 is received within the recess 132 defined in the vertical strut 130 and the cutting blade 98, and the cutting blade 98 of the knife 90 extends across the tissue gap defined between the anvil assembly 20 and the cartridge assembly 22. As the knife 90 pivots from the non-deployed position towards the deployed position, the abutment 106 on the distal portion 96 of the knife 90 engages the lockout member 66 of the lockout mechanism 60 to pivot the lockout member 66 in the direction indicated by arrow “C” (FIG. 13) to the unlocked position outwardly of the internal channel 37 in the channel member 26 to allow the drive assembly 120 to pass towards the drive advanced position. When the lockout member 66 moves towards the unlocked position, the biasing member 64 resiliently deforms outwardly.

[0048] FIGS. 9 and 10 illustrate the drive assembly 120 as the drive assembly 120 moves in the direction indicated by arrow “D” from the drive advanced position toward the drive retracted position. It is noted that the actuation sled and knife assembly 54 remain in the distal end of the cartridge body 38 when the drive assembly 120 is retracted. When a proximal angled portion 130a of the vertical strut 130 engages the lockout member 66 of the lockout mechanism 60, the lockoutmember 66 is urged towards the unlocked position to allow the lockout member 66 to move in the direction of arrow “E” to the unlocked position to allow the working member 124 of the drive assembly 120 to pass proximally of the lockout member 66. With the lockout member 66 in the locked position and the drive assembly 120 in the drive retracted position, the lockout member 66 returns to a position within the internal channel 37 of the channel member 26 to prevent readvancement of the drive assembly 120.

[0049] With reference to FIG. 11, a surgical robotic system 210 includes a control tower 220, which is connected to all of the components of the surgical robotic system 210 including a surgeon console 230 and one or more movable carts 260. Each of the movable carts 260 includes a setup arm 261 supporting a robotic arm 240 having an instrument, such as a robotic stapler 250 coupled thereto. The robotic arms 240 also couple to the movable carts 260. The robotic system 210 may include any number of movable carts 260 and / or robotic arms 240.

[0050] The robotic stapler 250 is configured for use during minimally invasive surgical procedures. In embodiments, the robotic stapler 250 may be a surgical stapler including a pair of jaws configured to grasp and clamp tissue while deploying a plurality of tissue fasteners, e.g., staples, and cutting stapled tissue.

[0051] One of the robotic arms 240 may include an endoscopic camera 251 configured to capture video of the surgical site. The endoscopic camera 251 may be a stereoscopic endoscope configured to capture two side-by-side (i.e., left and right) images of the surgical site to produce a video stream of the surgical scene. The endoscopic camera 251 is coupled to a video processing device 256, which may be disposed within the control tower 220. The video processing device 256 may be any computing device as described below configured to receive the video feed from the endoscopic camera 251 and output the processed video stream.

[0052] The surgeon console 230 includes a first display 232, which displays a video feed of the surgical site provided by camera 251 disposed on the robotic arm 240, and a second display 234, which displays a user interface for controlling the surgical robotic system 210. The first display 232 and second display 234 may be touchscreens allowing for displaying various graphical user inputs. The surgeon console 230 also includes a plurality of user interface devices, such as foot pedals 236 and a pair of input handle controllers 238a and 238b, which are used by a user to remotely control robotic arms 240. The surgeon console further includes an armrest 233 used to support the clinician’s arms while operating the input controllers 238a and 238b.

[0053] The control tower 220 includes a display 223, which may be a touchscreen that may display the graphical user interfaces (GUIs). The control tower 220 also acts as an interface between the surgeon console 230 and one or more robotic arms 240. In particular, the control tower 220 is configured to control the robotic arms 240, such as to move the robotic arms 240 and the corresponding robotic stapler 250, based on a set of programmable instructions and / or input commands from the surgeon console 230, in such a way that robotic arms 240 and the robotic stapler 250 execute a desired movement sequence in response to input from the foot pedals 236 and the input controllers 238a and 238b.

[0054] Each of the control tower 220, the surgeon console 230, and the robotic arm 240 includes a respective computer 221, 231, 241. The computers 221, 231, 241 are interconnected to each other using any suitable communication network based on wired or wireless communication protocols. The term “network,” whether plural or singular, as used herein, denotes a data network, including, but not limited to, the Internet, Intranet, a wide area network, or a local area network, and without limitation as to the full scope of the definition of communication networks as encompassed by the present disclosure. Suitable protocols include, but are not limited to, transmission control protocol / internet protocol (TCP / IP), datagram protocol / internet protocol (UDP / IP), and / or datagram congestion control protocol (DCCP). Wireless communication may be achieved via one or more wireless configurations, e.g., radio frequency, optical, Wi-Fi, Bluetooth (an open wireless protocol for exchanging data over short distances, using short length radio waves, from fixed and mobile devices, creating personal area networks (PANs), ZigBee® (a specification for a suite of high level communication protocols using small, low-power digital radios based on the IEEE 122.15.4-1203 standard for wireless personal area networks (WPANs)).

[0055] The computers 221, 231, 241 may include any suitable processor (not shown) operably connected to a memory (not shown), which may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and / or set of instructions described in the present disclosure including, but not limited to, a hardware processor, a field programmable gate array (FPGA), a digital signal processor (DSP), a central processing unit (CPU), a microprocessor, and combinations thereof. Those skilled in the art will appreciate that the processor may be substitutedby using any logic processor (e.g., control circuit) adapted to execute algorithms, calculations, and / or set of instructions described herein.

[0056] With reference to FIG. 12, the IDU 252 is shown in more detail and is configured to transfer power and actuation forces from its motors 352a, 352b, 352c, 352d to the robotic stapler 250 to drive movement of components of the robotic stapler 250, such as articulation, rotation, pitch, yaw, clamping, cutting, etc.

[0057] The IDU 252 includes a motor pack 350 and a sterile barrier housing 330. Motor pack 350 includes motors 352a, 352b, 352c, 352d for controlling various operations of the robotic stapler 250. The robotic stapler 250 is removably couplable to IDU 252. As the motors 352a, 352b, 352c, 352d of the motor pack 350 are actuated, rotation of the drive transfer shafts 354a, 354b, 354c, 354d of the motors 352a, 352b, 352c, 352d, respectively, is transferred to the drive assemblies of the robotic stapler 250. The robotic stapler 250 is configured to transfer rotational forces / movement supplied by the IDU 252 (e.g., via the motors 352a, 352b, 352c, 352d of the motor pack 350) into longitudinal movement or translation of the cables or drive shafts to effect various functions of an end effector.

[0058] Each of the motors 352a, 352b, 352c, 352d includes a current sensor 353, a torque sensor 355, and a position sensor 357. For conciseness only operation of the motor 352a is described below, however, it will be understood that motors 352b-d may operate in a similar manner. The sensors 353, 355, 357 monitor the performance of the motor 352a. The current sensor 353 is configured to measure the current draw of the motor 352a and the torque sensor 355 is configured to measure motor torque. The torque sensor 355 may be any force or strain sensor including one or more strain gauges configured to convert mechanical forces and / or strain into a sensor signal indicative of the torque output by motor 352a. Position sensor 357 may be any device that provides a sensor signal indicative of the number of rotations of the motor 352a, such as a mechanical encoder or an optical encoder. Parameters which are measured and / or determined by position sensor 357 may include speed, distance, revolutions per minute, position, and the like. The sensor signals from sensors 353, 355, 357 are transmitted to an IDU controller (not shown), which then controls the motors 352a, 352b, 352c, 352d based on the sensor signals. In particular, the motors 352a, 352b, 352c, 352d are controlled by an actuator controller 359, which controls torque output and angular velocity of the motors 352a, 352b, 352c, 352d. In embodiments, additional position sensors may also be used, which include, but are not limited to, potentiometers coupled to movablecomponents and configured to detect travel distances, Hall Effect sensors, accelerometers, and gyroscopes. In embodiments, a single controller can perform the functionality of the IDU controller and the actuator controller 359.

[0059] With reference to FIG. 13, a surgical robotic stapler 250 is coupled to one of the robotic arms 240a-d and includes an adapter 360 having a housing 362 at a proximal end portion thereof and an elongated shaft 364 that extends distally from housing 362. Housing 362 of adapter 360 is configured to selectively couple to IDU 252, to enable motors 352a-d of IDU 252 to operate the loading unit 440 coupled to the robotic stapler 250. Housing 362 of adapter 360 supports a drive assembly that mechanically and / or electrically cooperates with motors 352a-d of IDU 252. Drive assembly 450 of robotic stapler 250 may include any suitable electrical and / or mechanical component to effectuate driving force / movement.

[0060] Elongated shaft 364 is configured to couple to a loading unit 440 having an end effector 444. With reference to FIGS. 13-15, the loading unit 440 includes a proximal body portion 442 and the end effector 444. Proximal body portion 442 is releasably attached to a distal end portion of the robotic stapler 250, and end effector 444 is pivotally attached to a distal end of proximal body portion 442. End effector 444 includes an anvil assembly 446 and a cartridge assembly 448. Anvil assembly 446 is pivotable in relation to the cartridge assembly 448 and is movable between an open or unclamped position and a closed or clamped position. Proximal body portion 442 includes a drive assembly 450.

[0061] Drive assembly 450 includes a drive shaft 454, which may be flexible, and has a distal end portion 454a and a proximal engagement section 454b. The distal end portion 454a includes an I-beam 455 having a knife 455a. The I-beam 455 is configured to travel through the anvil assembly 446 and the cartridge assembly 448, thereby pushing the anvil assembly 446 toward the cartridge assembly 448 to clamp tissue. The proximal engagement section 454b includes diametrically opposed inwardly extending fingers 454c that engage a drive member (not shown) of the robotic stapler 250 to fixedly secure drive member to the proximal end of flexible drive shaft 454. Drive member is actuated by the IDU 252. The end effector 444 is pivotally coupled to a base 443 and is articulated via an articulation link 445, which is longitudinally movable by one of the motors 352a-d of the IDU 252.

[0062] Cartridge assembly 448 of end effector 444 includes a staple cartridge 458 removably supported in a carrier 460. Staple cartridge 458 defines a central longitudinal slot 458a, and aplurality of linear rows of staple retention slots 458b positioned on each side of the central longitudinal slot 458a. Each of the staple retention slots 458b receives a staple 462 and a portion of a staple pusher 464. During operation, drive assembly 450 abuts an actuation sled 466 and pushes actuation sled 466 through the staple cartridge 458. As the actuation sled 466 moves through staple cartridge 458, cam wedges of the actuation sled 466 sequentially engage staple pushers 464 to move staple pushers 464 vertically within staple retention slots 458b and sequentially eject the staples 462 therefrom for formation against an anvil plate 446a of anvil assembly 446. In addition, the drive shaft 454 closes the anvil assembly 446 and the cartridge assembly 448 and simultaneously advances the knife 455a and the actuation sled 466. Once clamping, cutting, and stapling are completed, the drive shaft 454 is retracted in a reverse (i.e., proximal) direction.

[0063] The loading unit 440 includes a lockout mechanism 470 disposed at a proximal end portion of the drive assembly 450. The lockout mechanism 470 is locked out upon attachment of the cartridge whether from a cartridge based system or a reload based system.

[0064] When the drive assembly 450 retracts, the lockout mechanism 470 passes over additional projections until it is positioned proximally to the final projection, where it locks into place. This configuration prevents the stapler from being refired. If an attempt is made to refire, the control rod contacts the lockout mechanism 470, which rotates into a locked position against the projection, blocking further movement and preventing reactivation of the device. This effectively disables the stapler after one use, ensuring that it cannot be reused improperly. Detailed description of operation of the lockout mechanism 470 in the loading unit 440 is provided in U.S. Patent No.6,241,139 titled “Surgical Stapling Apparatus”, the entire disclosure of which is incorporated by reference herein. The lockout mechanism 470

[0065] FIG. 15 shows a flow chart of a method 500 for automated pre-fire mechanical lockout verification according to an embodiment of the present disclosure. The method may be embodied as software instructions stored in memory and executable by a processor (e.g., main controller 147). While the method is described with respect to the stapler 10, the method is applicable to the robotic system 210 described above as well.

[0066] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by ahardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0067] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0068] At step 502 the interlock verification process is initiated in response to one or more of the following events: attachment of reload or cartridge, during clamp test, or after user input via the user interface of the surgical stapler 10 (e.g., pressing the safety button 21) or robotic system 210. If performed during the clamp test, the anvil assembly 20 is approximated toward the cartridge assembly 22 to reach a fully clamped position as shown in FIG. 7. In addition, the verification process may result in clamping if the actuation sled 52 is disposed distally of the point at which full clamp is achieved. The term “fully clamped” refers to the position of the tool assembly 16, where the anvil assembly 20 and the cartridge assembly 22 are approximated toward each other to securely hold tissue between them in preparation for firing. In this position, the anvil assembly 20 and cartridge assembly 22 have moved from the unclamped position (FIG. 1) to the clamped position (FIG. 7), with the drive assembly 120 having advanced the vertical strut 130 to pivot the anvil assembly 20 towards the cartridge assembly 22, as indicated by the direction of movement in FIG. 7.

[0069] At step 504 the drive assembly 120 is advanced (e.g., past the fully clamped position) to move the vertical strut 130 to the interlock zone as shown in FIG. 10. With respect to FIG. 14, the system detects lockout prior to clamping on tissue - so if the interlock is not detected - the system 210 or the surgical stapler 10 do not immediately enter firing they will be able to continue through the process until firing is requested. In other words, the verification algorithm will not prevent use of the cartridge / reload if interlock is not detected but if the interlock is detected the algorithm will output an error and require a new cartridge to be attached.

[0070] At step 506, the main controller 147 checks whether the vertical strut 130 engages the lockout member 66 while in the interlock zone. The main controller 147 may detect the engagement based on any of the motor or mechanical parameters measured by the sensors 160a-n by comparing one or more operational parameters to thresholds indicative of mechanical hard stops, such as, motor current draw exceeding a threshold, motor torque exceeding a threshold, mechanical strain on the drive assembly 120 exceeding a threshold, and the like. For instance, the system may detect the engagement by monitoring whether motor current draw exceeds a predetermined threshold, motor torque surpasses a specified limit, or mechanical strain on the drive assembly 120 exceeds a threshold value. The lockout threshold represents a specific value for current, torque, or strain that corresponds to the engagement of the lockout mechanism. For example, if the current drawn by the motor exceeds the threshold or if the torque and strain values surpass their respective limits, the system interprets this as a mechanical hard stop, indicating that the lockout mechanism is engaged. This threshold is specifically calibrated for the conditions encountered in the interlock zone and is continuously monitored during the advancement of the drive assembly 120.

[0071] If the cartridge assembly 22 was previously fired or the sled 52 is missing, at step 508, interlock is detected in the manner described above. At step 510, an error is indicated via the display 146 and / or as an auditory alert. In addition, the stapler 10 may prevent further actuation of the fire button 19 such that the stapler 10 does not fire the defective cartridge (e.g., previously fired cartridge assembly 22 or cartridge with missing sled 52. Thereafter, at step 512 the drive assembly 120 is retracted from the interlock zone of FIG. 10 (e.g., to the fully clamped position of FIG. 7 or any other position). This step occurs also if the interlock is not detected during step 510.

[0072] In addition, the display 146 may indicate that the interlock was not detected, and the firing process may be commenced. The firing process is then enabled by the main controller 147 and the stapler 10 may then proceed with the firing process by pressing the fire button 19 (e.g., second time), in response to which the main controller 147 activates one of the motors 152a-c to advance the drive assembly 120 moving the vertical strut 130 distally all the way through the cartridge assembly 22 ejecting the staples and cutting the stapled tissue.

[0073] The method may also include outputting messages on a display, such as display 146, to indicate the status of the lockout mechanism. Specifically, if the lockout mechanism is activated, the system may display a message such as “Lockout Mechanism Activated.” Conversely, if thelockout mechanism is not engaged, a message such as “Lockout Mechanism Not Activated” may be shown.

[0074] The interaction between the system and the user may involve pressing specific buttons on the handle assembly 12. For instance, pressing the safety button 21 first initiates the verification process. The fire button 19, on the other hand, becomes operable only after the verification process is completed successfully and the lockout is cleared. If the system detects that the lockout is not activated, the message on the display may indicate that the stapler is ready for use, allowing the user to proceed by pressing the fire button 19.

[0075] Additionally, the operational parameters used in the verification process, such as motor torque or current draw, may be detected using sensors like a torque sensor or current sensor, for example sensor 160a-n. If the operational parameter is force imparted on the drive assembly, a strain gauge 160b may be used to measure this force. Based on the data from these sensors, the system determines whether the lockout mechanism is engaged, and the appropriate message is displayed to the user.

[0076] Further aspects and embodiments of the present disclosure are set out in the below numbered clauses:1. A powered or robotic surgical stapler comprising:a housing including a motor;an elongated body extending from the housing;an end effector or a cartridge assembly removably attached to the elongated body, the end effector or the cartridge assembly includes a lockout mechanism activatable when the attached end effector or the cartridge assembly is defective;a drive assembly operatively connected to the motor, wherein activation of the motor causes the drive assembly to longitudinally move through the cartridge assembly;a sensor configured to measure an operational parameter of the motor or of the drive assembly; anda processor operatively connected to the motor, the processor configured to:perform an interlock verification process to determine whether the lockout mechanism is activated, the interlock verification process including:controlling the motor to advance the drive assembly to a verification position;comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; anddetermining whether the lockout mechanism is activated based on the comparison; anddisable a firing process in response to the determination the lockout mechanism is activated, wherein during the firing process the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly.2. The powered or robotic surgical stapler according to clause 1 , wherein a defect in the end effector or the cartridge includes at least one of being previously used or missing at least one of component.3. The powered or robotic surgical stapler according to clause 2, wherein the processor is further configured to enable the firing process in response to a determination the lockout mechanism is not activated.4. The powered or robotic surgical stapler according to clause 3, further comprising:a display configured to output at least one of a first message indicating the lockout mechanism is not activated or a second message indicating the lockout mechanism is activated.5. The powered or robotic surgical stapler according to any of clauses 1 to 4, wherein the processor is further configured to control the motor to retract the drive assembly prior to commencing the firing process.6. The powered or robotic surgical stapler according to any of clauses 1 to 5, further comprising:a user input interface configured to receive user input to initiate the interlock verification process.7. The powered or robotic surgical stapler according to any of clauses 1 to 6, wherein the processor is further configured to autonomously initiate the interlock verification process in response to attachment of the end effector or the cartridge assembly.8. The powered or robotic surgical stapler according to any of clauses 1 to 7, wherein the operational parameter is a motor parameter is one of torque, current draw, or force imparted on the drive assembly and the sensor is one of a torque sensor, a current sensor, or a strain gauge, respectively.9. A powered or robotic surgical stapler comprising:a housing including a motor;an elongated body extending from the housing;an end effector positioned at the distal end of the elongated body, the end effector including:a cartridge assembly;a drive assembly operatively connected to the motor, wherein activation of the motor causes the drive assembly to longitudinally move through the cartridge assembly;a lockout mechanism engaged by the drive assembly and activatable in response to the end effector or the cartridge assembly being defective;a sensor configured to measure an operational parameter of the motor or of the drive assembly; anda processor operatively connected to the motor, the processor configured to:perform an interlock verification process to determine whether the lockout mechanism is activated, the interlock verification process including:controlling the motor to advance the drive assembly to a verification position;comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; anddetermining whether the lockout mechanism is activated based on the comparison; anddisable a firing process in response to the determination the lockout mechanism is activated, wherein during the firing process the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly.10. The powered or robotic surgical stapler according to clause 9, wherein the processor is further configured to enable the firing process in response to a determination the lockout mechanism is not activated.11. The powered or robotic surgical stapler according to clause 10, further comprising: a display configured to output at least one of a first message indicating the lockout mechanism is not activated or a second message indicating the lockout mechanism is activated.12. A method for verifying interlock status in a powered or robotic surgical stapler comprising:detecting attachment of an end effector or a cartridge assembly to the stapler;upon attachment of the end effector or the cartridge assembly, performing an interlock verification process using a processor to determine whether a lockout mechanism activatable when the end effector or the cartridge attached to the stapler is defective, the interlock verification process including:controlling a motor to advance a drive assembly of the stapler to a verification position, the drive assembly operatively connected to the motor, wherein activation of the motor causes the drive assembly to move longitudinally through the end effector or the cartridge;measuring an operational parameter of the motor of the drive assembly using a sensor;comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; and determining whether the lockout mechanism is activated based on the comparison; anddisabling, using the processor, a firing process in response to the determination the lockout mechanism is activated.13. The method according to clause 12, further comprising enabling, using the processor, a firing process during which the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly in response to a determination the lockout mechanism is not activated.14. The method according to clause 13, further comprising:outputting on a display a message indicating the lockout mechanism is not activated.15. The method according to any one of clauses 12 to 14, further comprising:outputting on a display a message indicating the lockout mechanism is activated.16. The method according to any one of clauses 12 to 15, further comprising:controlling the motor using the processor to retract the drive assembly prior to commencing the firing process.17. The method according to any one of clauses 12 to 16, further comprising:receiving an input at a user input interface and initiating the interlock verification process in response thereto.18. The method according to any one of clauses 12 to 17, further comprising:autonomously initiating using the processor the interlock verification process in response attachment of the end effector or the cartridge assembly.19. The method according to any one of clauses 12 to 18, wherein a defect in the end effector or the cartridge includes at least one of being previously used or missing at least one of component.20. The method according to any one of clause 12 to 19, wherein the operational parameter is a motor parameter is one of torque, current draw, or force imparted on the drive assembly and the sensor is one of a torque sensor, a current sensor, or a strain gauge, respectively.

[0077] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the disclosure. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the disclosure. Also, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A powered or robotic surgical stapler (10, 250) comprising:a housing (12, 362) including a motor (152a-c, 352a-d);an elongated body (14, 364) extending from the housing;an end effector (16, 444) or a cartridge assembly (22, 448) removably attached to the elongated body, the end effector or the cartridge assembly includes a lockout mechanism (60, 470) activatable when the attached end effector or the cartridge assembly is defective;a drive assembly (120, 450) operatively connected to the motor, wherein activation of the motor causes the drive assembly to longitudinally move through the cartridge assembly;a sensor (160a-n, 353, 355, 357) configured to measure an operational parameter of the motor or of the drive assembly; anda processor (147, 221, 231, 341) operatively connected to the motor, the processor configured to:perform an interlock verification process to determine whether the lockout mechanism is activated, the interlock verification process including:controlling the motor to advance the drive assembly to a verification position;comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; anddetermining whether the lockout mechanism is activated based on the comparison; anddisable a firing process in response to the determination the lockout mechanism is activated, wherein during the firing process the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly.

2. The powered or robotic surgical stapler according to claim 1, wherein a defect in the end effector or the cartridge includes at least one of being previously used or missing at least one of component.

3. The powered or robotic surgical stapler according to claim 2, wherein the processor is further configured to enable the firing process in response to a determination the lockout mechanism is not activated.

4. The powered or robotic surgical stapler according to claim 3, further comprising: a display (146, 223, 232, 234) configured to output at least one of a first message indicating the lockout mechanism is not activated or a second message indicating the lockout mechanism is activated.

5. The powered or robotic surgical stapler according to any of claims 1 to 4, wherein the processor is further configured to control the motor to retract the drive assembly prior to commencing the firing process.

6. The powered or robotic surgical stapler according to any of claims 1 to 5, further comprising:a user input interface (19, 21, 234) configured to receive user input to initiate the interlock verification process.

7. The powered or robotic surgical stapler according to any of claims 1 to 6, wherein the processor is further configured to autonomously initiate the interlock verification process in response to attachment of the end effector or the cartridge assembly.

8. The powered or robotic surgical stapler according to any of claims 1 to 7, wherein the operational parameter is a motor parameter is one of torque, current draw, or force imparted on the drive assembly and the sensor is one of a torque sensor (355), a current sensor (353), or a strain gauge (160b), respectively.

9. A powered or robotic surgical stapler (10, 250) comprising:a housing (12, 362) including a motor (152a-c, 352a-d);an elongated body (14, 364) extending from the housing;an end effector (16, 444) positioned at the distal end of the elongated body, the end effector including:a cartridge assembly (22, 448);a drive assembly (120, 450) operatively connected to the motor, wherein activation of the motor causes the drive assembly to longitudinally move through the cartridge assembly;a lockout mechanism (60, 470) engaged by the drive assembly and activatable in response to the end effector or the cartridge assembly being defective;a sensor (160a-n, 353, 355, 357) configured to measure an operational parameter of the motor or of the drive assembly; anda processor (147, 221, 231, 341) operatively connected to the motor, the processor configured to:perform an interlock verification process to determine whether the lockout mechanism is activated, the interlock verification process including:controlling the motor to advance the drive assembly to a verification position;comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; anddetermining whether the lockout mechanism is activated based on the comparison; anddisable a firing process in response to the determination the lockout mechanism is activated, wherein during the firing process the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly.

10. The powered or robotic surgical stapler according to claim 9, wherein the processor is further configured to enable the firing process in response to a determination the lockout mechanism is not activated.

11. The powered or robotic surgical stapler according to claim 10, further comprising:a display (146, 223, 232, 234) configured to output at least one of a first message indicating the lockout mechanism is not activated or a second message indicating the lockout mechanism is activated.

12. A method (500) for verifying interlock status in a powered or robotic surgical stapler (10, 250) comprising:detecting attachment of an end effector (16, 444) or a cartridge assembly (22, 448) to the stapler;upon attachment of the end effector or the cartridge assembly, performing an interlock verification process using a processor (147, 221, 231, 341) to determine whether a lockout mechanism (60, 470) activatable when the end effector or the cartridge attached to the stapler is defective, the interlock verification process including:controlling a motor (152a-c, 352a-d) to advance a drive assembly (120, 450) of the stapler to a verification position, the drive assembly operatively connected to the motor, wherein activation of the motor causes the drive assembly to move longitudinally through the end effector or the cartridge;measuring an operational parameter of the motor of the drive assembly using a sensor (160a-n, 353, 355, 357);comparing the operational parameter to a threshold indicative of engagement of the drive assembly with the lockout mechanism at the verification position; and determining whether the lockout mechanism is activated based on the comparison; anddisabling, using the processor, a firing process in response to the determination the lockout mechanism is activated.

13. The method according to claim 12, further comprising enabling, using the processor, a firing process during which the drive assembly is advanced to eject a plurality of staples disposed in the end effector or the cartridge assembly in response to a determination the lockout mechanism is not activated.

14. The method according to claim 13, further comprising:outputting on a display a message indicating the lockout mechanism is not activated.

15. The method according to any one of claims 12 to 14, further comprising:outputting on a display (146, 223, 232, 234) a message indicating the lockout mechanism is activated.

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