Surgical stapler with electric handle

Abstract

The powered handle of the surgical stapler has a drive system including an electric motor. The powered handle includes a shaft recognition mechanism, so that when a reload shaft used with the surgical stapler is attached, the control system can activate the drive system with the recognized shaft. The powered handle further includes an LED light ring driven by a light control scheme that indicates the status of the handle. The control system also includes a startup module that evaluates the performance of the hardware and control system before use. The startup module evaluates different criteria depending on whether the handle is new, previously used, or previously reset. The control system of the powered handle further includes a lockout module configured to identify when a lockout has occurred. The lockout module applies different criteria depending on whether the motor is operating at or below maximum speed.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 63 / 107,336, entitled "Surgical Stapler Having a Powered Handle," filed on October 29, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] This application generally relates to surgical occlusion instruments and, more particularly, to surgical electric staplers.

Background Art

[0003] Surgical staplers are used to bring tissues together or clamp them and staple the clamped tissues together. Thus, surgical staplers have a mechanism for clamping tissues and passing staples through the tissues. As a result, multiple triggers and handles have been produced in relation to complex mechanisms for, for example, correctly stapling clamped tissues. Due to these complex mechanisms, surgical staplers can have high manufacturing overheads and potential sources of device failure and user confusion. Thus, it is desirable to be able to reliably staple clamped tissues without the accompaniment of complex mechanisms.

[0004] Surgical staplers having an electric motor can suppress the mechanical complexity described above. Electric surgical staplers can incorporate a control system that facilitates reliable operation of the stapler and the transmission of the stapling state to the user.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

[0006] In some embodiments of this specification, a surgical stapling system is provided. The surgical stapling system includes a handle body, an electric motor, an actuating shaft, a coupler, and a shaft recognition mechanism. The handle body includes a fixed handle and a trigger pivotably coupled to the handle body. The electric motor is located within the handle body. The actuating shaft is slidable along its longitudinal axis within the handle body. The coupler is configured to be removably coupled to a reload shaft assembly. The shaft recognition mechanism includes a lockout sleeve that is longitudinally movable to a detection position when the reload shaft is inserted into the coupler and longitudinally movable to a predetermined recognition position when the reload shaft assembly is coupled to the coupler.

[0007] In some embodiments, a handle assembly for a surgical stapler is provided. The handle assembly includes a handle body, an electric motor, an actuation shaft, a motor gear, an auxiliary gear, and a control system. The handle body includes a fixed handle and a trigger pivotably coupled to the handle body. The electric motor is located within the handle body. The electric motor includes an output shaft. The actuation shaft is slidable along its longitudinal axis within the handle body. The actuation shaft includes a rack formed on it. The motor gear is coupled to the motor's output shaft. The auxiliary gear engages with the motor gear for drive and operably engages with the rack. The control system is operable to control the electric motor. The control system includes a startup module that is operable when power is supplied to the control system. The startup module includes a new handle submodule, a used handle submodule, and a reset detected submodule.

[0008] In some embodiments, a handle assembly for a surgical stapler having a removable coupled instrument shaft with a lockout mechanism is provided. The handle assembly includes a handle body, a power system, an actuation shaft, a position sensor, and a control system. The handle body includes a fixed handle and a trigger pivotably coupled to the handle body. The power system resides within the handle body. The power system includes a motor and a power supply that can be located within the handle body. The actuation shaft is operably coupled to the power system. The actuation shaft is longitudinally slidable within the handle body. The position sensor is configured to determine the longitudinal position of the actuation shaft. The control system is electrically coupled to the power system, the trigger, and the position sensor. The control system includes a lockout module configured to monitor the motor current draw and the longitudinal position of the actuation shaft, calculate the slope of the motor current draw profile, and use the monitored slope to detect engagement of the lockout mechanism. The lockout module applies a first evaluation criterion to detect lockout engagement when the motor is operating in the maximum pulse width modulation state, and applies a second evaluation criterion to detect lockout engagement when the motor is not operating in the maximum pulse width modulation state. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of an embodiment of a surgical stapling system having an electric handle. [Figure 2] Figure 1 is a side view of the electric handle of the surgical stapling system. [Figure 3] Figure 2 is a partially cutaway perspective view of the electric handle with components removed to show the drive system. [Figure 4] Figure 2 is a perspective view of an embodiment of the electric steering drive system. [Figure 5] Figure 4 is a perspective view of the drive system. [Figure 6] Figure 4 is an exploded perspective view of the drive system. [Figure 7] It is a perspective view of the drive system of FIG. 4. [Figure 8] It is a perspective view of an embodiment of the power supply of the electric handle of FIG. 2. [Figure 9] It is a cross-sectional perspective view of an embodiment of the power supply of FIG. 8. [Figure 10] It is a top view of the notch of the electric handle of FIG. 2. [Figure 11] It is a top view of the notch of an embodiment of the articulation mechanism of the electric handle of FIG. 2. [Figure 12] It is a top view of the notch of the articulation mechanism of FIG. 10 in the articulation position. [Figure 13] It is a top view of the notch of the articulation mechanism of FIG. 10 in another articulation position. [Figure 14] It is a top view of the notch of the articulation mechanism of FIG. 10 with the release button actuated in the central position. [Figure 15] It is a top view of the notch of the articulation mechanism of FIG. 10 with the release button actuated in the central position. [Figure 16] It is a top view of the notch of the electric handle of FIG. 2 with the articulation mechanism in the lockout configuration. [Figure 17] It is a top view of the notch of the electric handle of FIG. 2 with the articulation mechanism in the unlocked configuration. [Figure 18] It is a perspective view of the drive system and the articulation mechanism of the electric handle of FIG. 2. [Figure 19A] It is a perspective view of the articulation link and the lockout arm of the articulation mechanism of the electric handle of FIG. 2. [Figure 19B] It is a side view of an embodiment of the reload shaft of the surgical stapling system of FIG. 1. [Figure 19C] It is a perspective end view of the proximal end of the reload shaft of FIG. 19B. [Figure 19D] It is a side view of some embodiments of the lockout key groove of the reload shaft of FIG. 19B. [Figure 19E] It is a perspective view of the lockout sleeve of the electric handle of FIG. 2. [Figure 19F]It is a schematic diagram showing the coupling operation between the embodiment of the lockout key groove of the reload shaft and the lockout sleeve of the electric handle. [Figure 19G] It is a cutaway perspective view of the electric handle and the reload shaft in which the reload shaft has advanced in the proximal direction during the coupling operation. [Figure 19H] It is a cutaway perspective view of the electric handle and the reload shaft where the reload shaft is coupled to the electric handle. [Figure 19I] It is a cutaway perspective view of the lockout arm of the articulation mechanism and the shaft recognition mechanism of the electric handle in FIG. 2. [Figure 19J] It is a side view of an embodiment of a circuit board including a shaft recognition sensor for the shaft recognition mechanism of the electric handle in FIG. 2. [Figure 19K] It is an exemplary distribution of the shaft recognition zones of the shaft recognition sensors in FIG. 19J. [Figure 20] It is a perspective view of the electric handle in FIG. 2 where the override return mechanism is in the released configuration. [Figure 21] It is a perspective view of the electric handle in FIG. 2 that is unlocked so that the override return mechanism moves to the return configuration. [Figure 22] It is a partial cutaway perspective view of the electric handle in FIG. 2 that is unlocked so that the override return mechanism moves to the return configuration. [Figure 23] It is a partial cutaway side view of the electric handle in FIG. 2 where the override return mechanism is in the released configuration. [Figure 24] It is a partial cutaway side view of the electric handle in FIG. 2 that is unlocked so that the override return mechanism moves to the return configuration. [Figure 25] It is a perspective view of the electric handle in FIG. 2 where the override return mechanism is in the return configuration. [Figure 26] It is a partial cutaway perspective view of the electric handle in FIG. 2 where the override return mechanism is in the return configuration. [Figure 27] It is a partial cutaway perspective view of the electric handle in FIG. 2 where the override return mechanism is in the return configuration and the manual return cycle has been started. [Figure 27A] Figure 2 is a perspective view of the return pawl of the override return mechanism of the electric handle. [Figure 27B] Figure 2 is a side view of the override return mechanism of the electric steering wheel. [Figure 27C] Figure 2 is a side view of the override return mechanism of the electric steering wheel. [Figure 28] This is a side view of another embodiment of the override return mechanism of a surgical stapler. [Figure 29] Figure 28 is a perspective view of the override return mechanism. [Figure 30] Figure 28 is a perspective view of the override return mechanism. [Figure 31] Figure 28 is a side view of the override return mechanism. [Figure 32] This is a perspective view of a reload cartridge used in several embodiments of a surgical stapling device. [Figure 33] This is a perspective view of the launch beam and launch member used in several embodiments of the elongated shaft assembly of a surgical stapling device. [Figure 34] This is a partially exploded perspective view of the proximal end of the jaw assembly in several embodiments of an elongated shaft assembly of a surgical stapling device. [Figure 35] This is a cutaway side view of the proximal end of a jaw assembly in several embodiments of an elongated shaft assembly for a surgical stapling device. [Figure 36] Figure 35 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 37] Figure 35 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 38] Figure 35 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload partially inserted. [Figure 39] Figure 35 is a cutaway side view of the proximal end of the jaw assembly with an unfired reload inserted. [Figure 40] This is a cutaway side view of the proximal end of the jaw assembly in Figure 35, with at least a partially fired reload inserted. [Figure 41] Figure 35 is a cutaway side view of the proximal end of the jaw assembly without a reload inserted. [Figure 42] Figure 2 is a partially cutaway side view of an electric handle having an electrically coupled optical ring user display. [Figure 43] Figure 2 is a side view of the optical ring user display for the electric handle. [Figure 44] Figure 2 is a perspective view of the optical ring user display for the electric steering wheel. [Figure 45A] Figure 2 shows information and a power flow block diagram of an embodiment of the control system for the electric handle. [Figure 45B] Figure 2 is a block diagram of the process flow at the beginning of the embodiment of the startup module of the electric handle control system. [Figure 45C] Figure 2 is a block diagram of the process flow of the first part of a new handle submodule in an embodiment of the start module of the electric handle control system. [Figure 45D] Figure 2 is a block diagram of the process flow of the second part of a new handle submodule in an embodiment of the start module of the electric handle control system. [Figure 45E] Figure 2 is a block diagram of the process flow of the reset detected submodule in an embodiment of the startup module of the electric handle control system. [Figure 45F] Figure 2 is a block diagram of the process flow of the used handle submodule in an embodiment of the startup module of the electric handle control system. [Figure 46A] Figure 2 is an illustrative flowchart of the operation sequence of the electric handle. [Figure 46B] Figure 2 is an illustrative flowchart of the operation sequence of the electric handle. [Figure 47]Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during the gripping operation of an electric handle, such as an electric handle. [Figure 48] Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during the gripping operation of an electric handle, such as an electric handle. [Figure 49] Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during a gripping operation involving multiple trigger actions of an electric handle, such as the electric handle shown in Figure 2. [Figure 50] Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during a gripping operation encountered by a lockout mechanism in an electric handle, such as the electric handle shown in Figure 2. [Figure 51] Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during a gripping operation encountered by a lockout mechanism in an electric handle, such as the electric handle shown in Figure 2. [Figure 52] Figure 2 shows a plot of motor load versus elapsed time for one exemplary jaw assembly during a gripping operation involving multiple trigger actions encountered by the lockout mechanism in an electric handle, such as the electric handle shown in Figure 2. [Figure 53] This is an exemplary lockout mechanism control logic profile for an embodiment of an electric steering assembly. [Modes for carrying out the invention]

[0010] Figures 1 and 2 show embodiments of a surgical stapling system. The illustrated embodiment of the surgical stapler 10 includes an elongated shaft 20, a jaw assembly 30, and a handle assembly 40. Figure 1 shows the surgical stapler 10 with the jaw assembly 30 in an open configuration, and an embodiment of the electric handle having powered staple firing and manual jaw assembly articulation. Figure 2 shows the electric handle 40 of the surgical stapler system 10 with the elongated shaft removed. The electric handle 40 in Figure 2 has powered staple firing and manual jaw assembly articulation. In the illustrated embodiments, the shaft 20 and the jaw assembly 30 can be freely rotated around a longitudinal axis defined by the shaft 20 by rotating the rotary knob on the handle 40. In other embodiments, the stapling system can be configured to allow rotation of the jaw assembly within a predetermined range around the longitudinal axis, or to allow a rotatably fixed jaw assembly.

[0011] Continuing to refer to Figure 1, the illustrated embodiment of the surgical stapler 10 may have a size and configuration suitable for use in laparoscopic surgery. For example, the elongated shaft 20 and jaw assembly 30 may have a size and configuration suitable for introduction into the surgical field through an access port or trocar cannula. In some embodiments, the elongated shaft 20 and jaw assembly 30 may have a size and configuration suitable for insertion through a trocar cannula having a relatively small working channel diameter, such as less than 8 mm. In other embodiments, the elongated shaft 20 and jaw assembly 30 may have a size and configuration suitable for insertion through a trocar cannula having an even larger working channel diameter, such as 10 mm, 11 mm, 12 mm, or 15 mm. In other embodiments, it is conceivable that some aspects of the surgical stapler described herein may also be incorporated into a surgical stapling device used in open surgery.

[0012] Continuing to refer to Figure 1, as shown in the figure, the elongated shaft 20 includes a generally tubular member. The elongated shaft 20 extends from the proximal end to the distal end. The elongated shaft 20 defines the central longitudinal axis L of the surgical stapler 10, which extends between the proximal end 22 and the distal end 24.

[0013] Continuing to refer to Figure 1, in the illustrated embodiment, a jaw assembly 30 is coupled to the elongated shaft 20 at its distal end. The jaw assembly 30 includes a first jaw 32 and a second jaw 34 pivotably coupled to the first jaw 32. In the illustrated embodiment, the first jaw 32 is fixed to the distal end 24 of the elongated shaft 20 so as to extend distally along the central longitudinal axis L and articulate relative to the elongated shaft 20 in response to the articulation mechanism of the handle 40. In the initial configuration, the first jaw 32 includes a plurality of staples 36 arranged within the reload 50. In other embodiments, the reload 50 can be integrated with the jaw assembly 30 so that the entire shaft assembly 20 and the jaw assembly 30 loaded with staples constitute a single reload assembly. In some embodiments, the staples may also be initially located within the second jaw 34.

[0014] Continuing to refer to Figure 1, in the illustrated embodiment, the jaw assembly 30 can be operated from an open configuration (Figure 1) to a closed configuration relative to the staping configuration by a drive member or beam that is longitudinally slidable within an elongated shaft. In the initial position, the beam can be located at the distal end 24 of the elongated shaft 20. With the beam in the initial position, the jaw assembly 30 becomes open by the second jaw 34 pivoting away from the first jaw 32. As the actuating member or beam is translated distally along the longitudinal axis L, the actuating beam engages with the second jaw 34. When the actuating beam is translated distally by a first distance from the initial position, the jaw assembly can be operated from the open configuration to the closed configuration. When the jaw assembly 30 is in the closed configuration, the jaw assembly 30 can be returned to the open configuration by moving the actuating beam proximally by a first distance. The distal end of the working beam can advance a staple slider configured to deploy staples from the first jaw 32, so that as the working beam moves further distally beyond the first distance, multiple staples 36 are deployed from the reload 50 of the first jaw 32.

[0015] Continuing to refer to Figure 1, in the illustrated embodiment, the handle assembly is configured to be coupled to the elongated shaft 20 at its proximal end. As shown, the handle assembly 40 has a pistol grip configuration including a housing that defines a fixed handle 42 and a movable handle 44 or trigger pivotably coupled to the fixed handle 42. In other embodiments, it is assumed that surgical stapler devices, including the embodiments described herein, may also have handle assemblies in other configurations, such as a scissor grip configuration or an in-line configuration. As will be described in more detail below, the handle assembly 40 houses a powered actuation mechanism configured to selectively advance the actuation shaft in response to the movement of the movable handle 44.

[0016] In the illustrated embodiment, the surgical stapler 10 may include a plurality of staples 36 located within a disposable cartridge reload 50, while the jaw assembly 30 is configured to be reused with a plurality of staple cartridge reloads 50 in a single surgery. In some embodiments, the elongated shaft 20 and the jaw assembly 30 define a disposable reload shaft that can be detachably coupled to a handle assembly 40. Thus, in the illustrated embodiment, the handle assembly 40 includes a coupler 46 at its distal end. The coupler 46 is adapted to engage with the elongated shaft 20 of the surgical stapler 10. The coupler 46 may have a bayonet connection having an outer connector that can detachably couple the handle assembly 42 to the elongated shaft 20, a first inner connector that can detachably couple the working shaft of the handle assembly 42 to the drive member of the elongated shaft 20, and a second inner connector that can detachably couple the articulation coupler of the handle assembly 42 to the articulation link of the elongated shaft 20. These three detachable couplings occur simultaneously when the elongated shaft 20 is coupled to the handle assembly 42. Therefore, the surgical stapler 10 can be configured so that the handle assembly 40 can be reused along with the multiple reload shafts 20 during surgery. In other embodiments, it is assumed that the handle assembly and some parts of the elongated shaft can be reused, while the remaining part of the elongated shaft in the jaw assembly constitutes a disposable cartridge. In some other embodiments, the handle assembly and elongated shaft can be reused, while the jaw assembly constitutes a disposable cartridge. In yet another embodiment, the jaw inserts that house multiple staples may constitute a disposable cartridge, while the rest of the surgical stapler is reusable.

[0017] Figure 2 shows an embodiment of an electric handle for a surgical stapling system. The electric handle can be used with various shaft reloads and cartridges, allowing the shaft configuration, jaw assembly configuration, and staple configuration to be selected to suit a specific surgery. In the illustrated handle embodiment, jaw clamping and release, as well as staple line firing, are performed electrically (motor-driven). The joint movement of the jaw assembly can be manually controlled by an articulation knob rotated by the operator. The motor is controlled by an implanted control system that determines the function of the handle during different stages of use.

[0018] Continuing to refer to Figure 2, the electric handle 40 includes a pistol grip configuration having a fixed handle 42 and a movable handle 44 or trigger pivotably coupled to the fixed handle 42. A power supply 130 or battery may be located on the underside of the fixed handle. The electric handle 40 may further include user controls such as a fire or fire / reverse button 150 that allows the user to selectively control the stapling sequence. The electric handle 40 may further include a redundant manual override return system 170 that allows the user to manually return the stapling system to an open configuration in the event of electric system failure, control system failure, power supply failure, "lockjaw" or other mechanical binding. The electric handle may further include a manual articulation mechanism including a rotatable articulation knob 190. In the illustrated embodiment, the articulation knob 190 is located at the proximal end of the electric handle and can rotate around an axis that substantially corresponds to the longitudinal axis of the stapling system. In some embodiments, the electric handle may further include an illuminated user display, such as an annular light ring, which displays a desired status indicia to the user.

[0019] Various embodiments of the powered handle assembly and associated operating mechanisms are disclosed in U.S. Patent Application Publication No. 16 / 287,748, filed February 27, 2019, entitled "Surgical Stapler Having a Powered Handle," U.S. Patent Application Publication No. 15 / 486,227, filed April 12, 2017, entitled "Reload Shaft Assembly for Surgical Stapler," and U.S. Patent Application Publication No. 15 / 486,008, also filed April 12, 2017, all of which are incorporated herein by reference in their entirety.

[0020] Electric drive system Figure 3 shows a partial cutaway view of the electric handle. In the illustrated cutaway view, several components of the electric handle have been removed to clearly show the drive system of the electric handle. In the illustrated embodiment, the drive system includes a motor 112 located within the fixed handle 42, a motor gear 114 located on the output shaft of the motor 112, and an auxiliary gear 116 that drives and engages with the motor gear 114. In some embodiments, the motor 112 is a brushed DC gear motor. The force transmission through the auxiliary gear 116 has the advantage that the motor 112 can be positioned laterally centered within the fixed handle, enabling improved handle balance and user ergonomics. Furthermore, in some embodiments, the motor gear 114 and the auxiliary gear 116 can be configured to provide a desired operating torque to the rack 122. In some embodiments, the motor 112 may include a multi-gear transmission that drives between the motor gear 114 coupled to the auxiliary gear 116 to provide a desired operating torque. The motor 112 can be electrically coupled to a power supply 130 via a control system. The control system within the handle works in conjunction with the drive system to measure the position of the actuation shaft 120 and, consequently, the operation of the jaw assembly.

[0021] The drive system is mounted on hardware that provides information to a control system, including a microcontroller in the handle. This embedded system can control the motor speed and torque. This embedded system can also control the function of the device based on user input (trigger movement and press of the fire / reverse button) and the position of the drive system. The control system can also measure feedback from the motor to determine whether the load is too high to continue firing staples or whether the reload cartridge lockout has been activated. The control system can also measure battery life to limit the number of shots the device can fire. The drive system is configured primarily for electric operation, but in some embodiments, it may be desirable to provide a manual return mechanism that takes precedence over electric operation, as further described herein.

[0022] Figures 4 to 6 show detailed diagrams of the electric handle drive system. In the illustrated embodiment, the drive system includes a bifurcated auxiliary gear 116 supported between its endpoints by a support plate 121. This support configuration for the auxiliary gear 116 has the advantage of providing a robust mechanism that can significantly reduce the tendency for the motor gear 114 to separate from the auxiliary gear 116 under heavy load conditions.

[0023] Referring to Figures 5 and 6, the branching auxiliary gear 116 includes a first gear segment 113 rotatably coupled to a second gear segment 115. The first gear segment 113 may include a first engagement surface, and the second gear segment 115 may include a second engagement surface, so that the first and second engagement surfaces are coupled to rotatably couple the first gear segment 113 to the second gear segment 115. In the illustrated embodiment, the first gear segment 113 includes a boss extending axially and defining a first engagement surface, and the second gear segment 115 includes a boss extending axially and defining a second engagement surface. The axially extending bosses of the first and second gear segments each include a square-toothed or "castle" cross-sectional shape that enables the rotational coupling of the first gear segment 113 and the second gear segment 115. In some embodiments, when the first and second gear segments 113 and 115 are rotatably coupled, the axially extending bosses engage with each other to form a central region having an outer diameter smaller than the outer diameter of either the first gear segment 113 or the second gear segment 115.

[0024] Figure 6 shows an exploded view of a drive system having a branching auxiliary gear 116. As shown, the drive system further includes a support plate 121 positioned between the first and second ends of the auxiliary gear 116. The support plate 121 can be a rigid plate on which the auxiliary gear bore 123 and the motor gear bore 125 are formed. In some embodiments, the support plate 121 can be made of a metallic material. The drive system may further include an auxiliary gear bushing 117 located within the auxiliary gear bore 123 and a motor gear bushing 119 located within the motor gear bore 125. The bushings 117 and 119 can be made of a material with a relatively low coefficient of friction, such as DELRIN® material. An operating shaft bracket or guide member 127 can facilitate engagement between the rack 122 of the operating shaft 120 and the second gear segment 115 of the auxiliary gear 116.

[0025] As can be seen with reference to Figures 5 and 6, the first gear segment 113 and the second gear segment 115 of the auxiliary gear 116 can be assembled around a support plate 121 such that the central region of the auxiliary gear 116 is supported between the first and second ends of the auxiliary gear 116, passing through the auxiliary gear bore 123 and the auxiliary gear bushing 117. In the illustrated embodiment, the first gear segment 113 of the auxiliary gear 116 gears with the motor gear 114. The second gear segment 115 of the auxiliary gear 116 gears with the rack surface 122 of the operating shaft 120. The support plate 121 can be enclosed by the wall of the handle assembly housing and the bosses formed therein to support the drive system.

[0026] As can be seen with reference to Figure 7, during electric operation, the auxiliary gear 116 meshes with the rack 122 on the actuation shaft 120, which extends longitudinally within the handle body. In the illustrated embodiment, the auxiliary gear is supported within a guide member, through which the actuation shaft 120 slides. The guide member 127 assists in maintaining meshed contact between the auxiliary gear 116 and the rack 122. The distal end of the actuation shaft 120 is freely rotatably coupled to an actuation adapter 124 that extends longitudinally within a coupler 46 (Figure 1) at the distal end of the electric handle.

[0027] The actuation adapter 124 connects to the drive member in the shaft 20 via a bayonet connection, by coupling the shaft 20 to the coupler 46 of the electric handle 40. Thus, when the shaft 20 is attached to the handle 40, the motor 112 and rack 122 drive the drive member that extends within the instrument shaft 20 and is coupled to the jaw assembly. Thus, the drive system within the handle includes a "rack and pinion" design. The operation of the motor 112 in response to user input drives the actuation shaft 120 longitudinally forward and backward, selectively operating the stapler in closing, firing, or opening operations.

[0028] Figures 8 and 9 show embodiments of the power supply 130 for the electric handle 40. The power supply 130 can be configured to supply DC to the electric handle motor and control system. In the illustrated embodiment, the stapler can operate at 12V. The illustrated power supply may include four 3V lithium-ion batteries 132 connected in series to form a 12V power supply. As shown, the batteries 132 are stacked in a 4x1 configuration within a plastic housing 134 to form a battery pack. In other embodiments, the battery pack can be formed using individual battery cells of a different number and configuration. For example, in some embodiments, the battery pack can be made of AA, AAA, or other standard or dedicated disposable or rechargeable chemical batteries. In the illustrated embodiment of the electric handle 40, the battery pack is located at the bottom of the fixed handle. This positioning is desirable as it provides a stable surface to set the handle 40 on a plane. In other embodiments, it is assumed that the power supply can also be located elsewhere in the handle, such as at the proximal end of the handle. The power supply 130 may include a main power switch and indicator lights such as light-emitting diodes. Indicator lights can be configured to display other power status information, such as the power on / off status, low power status, or recharge status, through the use of illumination color, flashing sequence, or solid illumination.

[0029] Continuing to refer to Figures 8 and 9, in some embodiments, the power supply 130 can be packaged together with the handle 40, but the power supply 130 is not installed before use. The user can install the battery pack by engaging the power supply 130 with the bottom of the handle 40 when in use. Shipping without the battery pack installed has the advantage of preventing unintended battery discharge before use. Furthermore, if the battery pack is removable, the stapler system can be easily upgraded with a new battery when a new battery becomes available. In other embodiments, the power supply can also be packaged and installed within the handle with a removable strip that disconnects the electrical connection of the battery pack. In yet another embodiment, a power cable configured to plug into an AC or DC power source such as a wall outlet, USB connector, or other standard electrical connection point can be included with the handle.

[0030] In some embodiments, the power supply further includes a memory module, such as a non-volatile memory, capable of storing a digital record of stapler usage. For example, the memory module may be configured to record details of each stapler firing, including periodic sampling of battery voltage and motor current during firing, a set of states of the software state machine, any possible unexpected events, the type of shaft used, the number of firings, the interval between firings, and the model and serial number of the stapler handle. The memory module may also be configured to record the use of a handle assembly to prevent a disposable handle assembly from being reused after being used in a surgical procedure. The memory module may also record whether the battery pack itself has been used to prevent the user from reusing the battery pack. In other embodiments, the memory module may be located within the handle assembly, separated from the power supply, so that the memory module is not integrated with the power supply, for example, on or electrically coupled to a circuit board 144 (Figure 4), or positioned so that it can be easily detached from an electrical port on the handle assembly.

[0031] In some embodiments, the electric handle 40 and associated power supply 130 can be configured to be used in a single surgery and discarded afterward. The power supply 130 may include a power drain to reduce the opportunity for reuse. The user can remove the battery pack from the handle 40 after use in a surgical procedure. Removing the battery pack from the handle 40 can initiate battery draining. For example, after the battery pack has been used once, a low-value resistor or a mechanical feature that allows the battery to be short-circuited by connecting terminals to an electrical feature can accomplish the same task for the circuit. Also, if the battery pack remains in the handle 40 after the completion of the surgical procedure, in some embodiments, the handle's control system is programmed to disable the function and drain the battery pack after a maximum time limit. For example, in embodiments of a power supply including a memory module, a microcontroller may include a firing management module that can modify a storage location, such as a firing count storage location on the memory module, after a predetermined number of firing strokes. The microcontroller may be configured to evaluate the firing count storage location in the startup operation sequence. If this memory location indicates that the battery is depleted, in some embodiments, the microcontroller can be configured to disable the stapler and activate the discharge circuit in the power supply. The microcontroller can also be configured to activate the discharge circuit under other predetermined operating conditions, such as if the handle assembly has been turned on for a predetermined period of time, such as longer than 12 hours in one embodiment; if more than a predetermined number of firings have occurred, such as 12 times in one embodiment; if the manual override reset mechanism has been deployed; or if an irrecoverable failure has occurred.

[0032] Figures 4 and 10 show embodiments of a position sensor mechanism used in an electric handle. During operation, as the motor gear 114 rotates, the crown gear 142 mounted in the handle 40 rotates in response. The crown gear 142 is coupled to a potentiometer, which allows the position of the motor gear 114, and therefore the actual position of the actuation rack, to be determined based on the measured change in resistance in the potentiometer. In some embodiments, the potentiometer can be mounted on a circuit board 144 on which a control system can be arranged. While the illustrated embodiments include a position sensor mechanism based on a potentiometer, other embodiments may also use other position sensing mechanisms, such as the use of a magnetic encoder including a Hall effect sensor, a limit switch that operates when the actuation shaft has moved a predetermined distance, a photodiode that measures the movement of a pattern along the actuation shaft, an optical encoder located on the motor shaft, or other position sensing systems.

[0033] Joint movement mechanism Figures 11 to 17 show embodiments of the articulation mechanism of the electric handle 40. In the illustrated embodiments, the handle can articulate the jaw assembly at the distal end of the shaft up to 45° in any direction relative to the longitudinal center position in the full articulated position. In some embodiments, the electric handle uses a manual articulation mechanism which includes a series of components coupled to a manually operated articulation knob 190 at the proximal end of the handle. In other embodiments, the manually operated articulation knob and some related elements of the articulation mechanism may be located at other positions on the handle, such as adjacent to the distal end of the handle.

[0034] As can be seen with reference to Figures 11 and 12, when the reload shaft is coupled to the handle, the articulation mechanism is coupled to an articulation member that extends longitudinally within the reload shaft. When the articulation mechanism acts longitudinally, the articulation member translates proximal or distal to the shaft, causing the jaw assembly at the distal end of the shaft to articulate.

[0035] Referring to Figure 11, the articular movement mechanism includes a ball screw 192 having at least one helical groove or thread 195 on which one or more ball bearings 194 can be mounted. In the illustrated embodiment, the articular movement mechanism includes two ball bearings 194 that can engage within two threads 195. The ball bearings 194 are positioned within a ball bearing aperture 189 of a ball sleeve 191 located radially outward from the ball screw 192. The ball bearings 194 are held within the threads 195 by a release sleeve 196 located radially outward from the ball bearings 194. When an articular movement knob 190, coupled to the ball sleeve 191 by a connecting pin 193 or the like, rotates, the ball sleeve 191 rotates around the axis of rotation, causing the ball bearings 194 to move within the threads 195, and correspondingly the ball screw 192 translates longitudinally. The articulation of the jaw assembly is achieved by the rotation of the articulation knob 190, which causes the ball sleeve 191 and ball bearing 194 to rotate around the axis of rotation, while their longitudinal positions remain constant along the axis of rotation. At this time, the ball bearing 194, engaged in the threads 195 of the ball screw 192, translates the ball screw 192 forward and backward along the axis of rotation. In the illustrated embodiment, the ball sleeve 191 is generally tubular with a cavity formed inside, and a portion of the ball screw 192 is located within the cavity and translates longitudinally within the cavity. The illustrated embodiment of the articulation mechanism includes two ball bearings that can engage with the threads of the ball screw, but in other embodiments, the articulation mechanism may have fewer than two or more ball bearings, such as a single ball bearing located in a single helical screw, or three or four or more ball bearings in a corresponding number of helical threads.

[0036] Referring to Figures 11 and 12, the ball screw 192 extends to a distal end 200 coupled to a pair of articulation links 202. The articulation links 202 are preferably spaced apart from each other so that they can be positioned radially outward from the drive system and actuation shaft within the handle. The distal ends of the articulation links 202 can be rotatably coupled to an articulation adapter 204, which can be coaxially positioned radially outward from the actuation adapter at the distal end of the handle. This rotatable coupling may include an articulation bearing 205 having relatively low friction characteristics. This articulation bearing 205 can facilitate the rotation of the coupled reload shaft relative to the handle assembly and the longitudinal movement of the articulation adapter 204 during the operation of the articulation mechanism. While the illustrated embodiment of the articulation mechanism includes two articulation links laterally offset from the actuation mechanism within the handle, other embodiments may also be assumed to have fewer than two or more articulation links, such as one articulation link or three or four or more articulation links.

[0037] Continuing to refer to Figures 11 to 13, the joint movement adapter 204 can be connected to the joint movement member within the shaft by a bayonet connection when the shaft is coupled to the handle. The thread 195 can be configured such that when the ball screw is moved proximal, the jaw assembly articulates to the left relative to the longitudinal center position when viewed from the handle, and when the ball screw 192 is moved distally, the jaw assembly articulates to the right relative to the longitudinal center position when viewed from the handle. Figures 12 and 13 show the joint movement mechanism in a fully articulated configuration that defines the end of the range of motion.

[0038] Since the helical threads 195 of the ball screw 192 are continuous, the articulation mechanism has the advantage that it can allow the jaw assembly to articulate to substantially infinite angular positions within a desired range of motion. In some embodiments, the articulation mechanism can be configured to provide an articulation range of motion of the jaw assembly of -45° to +45° with respect to a longitudinal center position defined by the longitudinal axis of the shaft. In other embodiments, the articulation mechanism can also be configured to provide other articulation ranges, including a range that provides articulation greater than + / -45° or a range that provides articulation less than + / -45°. In some embodiments, the articulation mechanism can be configured to provide articulation in a single direction with respect to the longitudinal center position.

[0039] In some embodiments, the pitch of the threads 195 on the ball screw 192 is variable. For example, the threads 195 may include a pitch that narrows relatively towards the ends of the thread to provide a mechanical advantage when the jaw assembly may require a large force to articulate. The threads 195 may also include a pitch that widens relatively towards the center of the thread to allow for quick movement at a relatively low mechanical advantage when the jaw assembly may require a small force to articulate. In other embodiments, the threads 195 include a constant pitch so that the amount of articulation of the stapler jaw assembly by rotating the articulation knob is proportional and does not change across the range of motion of the articulation mechanism. It is desirable that a ball screw with such a constant-pitch thread provides an easily predictable response during the operation of the actuation mechanism.

[0040] Referring to Figures 14 and 15, the joint movement mechanism may include a release mechanism that can reset the joint movement mechanism from any joint movement position to a longitudinal center position. The release mechanism is operated by the user pressing a release button 198. In the illustrated embodiment, the release button 198 is radially nested within the joint movement knob 190.

[0041] As can be seen with reference to Figure 14, when the release button 198 is operated, the release sleeve 196 advances distally. The radial inner surface of the release sleeve 196 has a step that includes an engagement surface 186 with a relatively small inner diameter and a release surface 188 with a relatively large inner diameter, with a smooth slope between the engagement surface and the release surface. During operation, the engagement surface of the release sleeve holds the ball bearing 194 within the threads 195 of the ball screw 192. When the release button 198 is pressed, the ball bearing 194 is released from the threads 195 as the engagement surface advances distally, allowing it to advance radially outward through the ball bearing aperture 189 within the ball sleeve and contact the release surface.

[0042] Continuing to refer to Figure 14, with the ball bearing 194 released from the thread 195, the joint movement mechanism can be biased to its central position. In some embodiments, the ball screw 192 is biased to its central position by a spring force from the shaft and biasing members such as two springs. The ball bearing 194, located at the central position along the thread 195, corresponds to the longitudinal center position of the jaw assembly.

[0043] As can be seen with reference to Figure 15, when the release button 198 is able to return to its original configuration (undisturbed configuration), the release sleeve 196 retracts proximally by a spring. As the release sleeve 196 moves proximally, the ball bearing 194 is forced to engage with the threads 195 of the ball screw. As a result, the jaw assembly can be articulated from its longitudinal center position using the articulation mechanism, or the stapler can be used with the jaw assembly in its longitudinal center position.

[0044] Figures 16-17 show shaft recognition and articulation lockout mechanism 300 in several embodiments of the articulation mechanism. The articulation mechanism may include an articulation lockout mechanism that maintains the articulation mechanism in a central position when the instrument shaft is not coupled to the handle assembly. Thus, the central position of the articulation adapter 204 is maintained, facilitating the bayonet coupling between the instrument shaft and the handle assembly described above. If the articulation mechanism is maintained in an engaged configuration even when the instrument shaft is not coupled to the handle assembly, it may become difficult to align the articulation member within the instrument shaft with the articulation adapter 204 when attempting to couple the instrument shaft to the handle assembly. In the illustrated embodiment of the handle assembly, the articulation lockout mechanism can be coupled to the shaft recognition mechanism.

[0045] Continuing with reference to Figures 16-17, the shaft recognition and joint movement lockout mechanism includes a lockout sleeve 302 at the distal end of the handle assembly and at least one lockout arm 304 coupled to the lockout sleeve. In the illustrated embodiment, the lockout sleeve 302 may be located radially outward of the joint movement adapter 204. As shown, the joint movement lockout mechanism includes two lockout arms 304 extending longitudinally within the handle assembly from a proximal end coupled to a release sleeve 196 to a distal end coupled to the lockout sleeve 302. The lockout arms may be located laterally outward of the joint movement link 202 and the actuation shaft 120, as well as other drive mechanism components. In other embodiments, more than one or two lockout arms 304 may be coupled to the lockout sleeve 302 and the release sleeve 196, or the lockout arms 304 may be positioned in different lateral positions than in the illustrated embodiment.

[0046] During operation, when the instrument shaft is coupled to the handle assembly, the lockout sleeve 302 contacts a boss, tab, collar, or other element at the proximal end of the instrument shaft. Because a bayonet coupling is in place, this contact causes the lockout sleeve to translate a predetermined amount in the proximal direction. When the instrument shaft is not coupled to the handle assembly (Figure 16), the joint movement lockout mechanism and release sleeve 196 are configured such that the release sleeve 196 is positioned with the ball bearing in contact with the release surface of the release sleeve 196. Thus, the joint movement mechanism is in a lockout configuration. Therefore, when the instrument shaft is not coupled to the handle assembly, the ball bearing is released from the threads of the ball screw, allowing the joint movement knob to be rotated without operating the joint movement mechanism.

[0047] As can be seen with reference to Figure 17, when the instrument shaft is coupled to the handle assembly, the articular movement lockout mechanism transitions to an engaged configuration. When the instrument shaft engages with the lockout sleeve, the lockout sleeve 302 and the lockout arm 304 coupled to it translate proximal. The proximal end of the lockout arm 304 is coupled to the release sleeve 196 of the articular movement mechanism, so that as the lockout arm 304 moves proximal, the release sleeve 196 also moves proximal, engaging the ball bearing with the threads of the ball screw. Therefore, when the instrument shaft is installed, rotating the articular movement knob translates the articular movement adapter, causing the end effector coupled to the instrument shaft to articulate.

[0048] Referring to Figures 18 and 19, each of the joint movement mechanism and the shaft recognition / joint movement lockout mechanism may include sensors 306, 308 that identify the position of their respective mechanisms. In the illustrated embodiments, the sensors of the joint movement mechanism may include a potentiometer that gear-engages with a toothed rack formed on one joint movement link 202, and the sensors of the shaft recognition / joint movement lockout mechanism may include a potentiometer that gear-engages with a lockout arm 304. In some embodiments, each sensor of the joint movement mechanism and the shaft recognition / joint movement latch mechanism may be mounted on a circuit board 144 on which a control system can be located. Thus, the control system can capture one or both of the joint movement position data and the shaft recognition position data during the opening / closing, firing, and return operations of the electric handle to modify the motor drive profile. For example, by capturing the joint movement position and applying correction values ​​to the measured actuator rack and actuator positions, the control system can control a specific operating state of the motor based on the actuator position corrected to take into account a given measured joint movement. The illustrated embodiment includes a position sensor mechanism based on a potentiometer, but it is assumed that other embodiments may use other position detection mechanisms.

[0049] Shaft recognition mechanism In some embodiments, the electric handle can be configured to be used with three reload shafts, each having a different jaw length. For example, the electric handle can be configured to be used with reload shafts having jaw lengths of approximately 30 mm, 45 mm, and 60 mm. The electric handle can be configured to operate with any of the reload shafts having a predetermined jaw length, and the reload shafts can be used and replaced throughout the target life of the device. Since the operating shaft of the electric handle can pass through different longitudinal positions during the gripping and firing operations of reload shafts having different jaw lengths, each of these jaw lengths can have a corresponding operating profile in the electric handle's control system, as will be further described with reference to Figures 45-46. Therefore, it is desirable that the electric handle include a shaft recognition mechanism that detects whether the reload shaft connected to the electric handle has a predetermined jaw length, whether an unrecognized shaft is connected, or whether no shaft is connected. When the control system recognizes a reload shaft having a particular jaw length, it can operate the electric handle using the corresponding operating profile. As described above, in some embodiments, the shaft recognition mechanism can be configured to distinguish reload shafts having jaw lengths of 30 mm, 45 mm, and 60 mm, while in other embodiments, the shaft recognition mechanism can be configured to distinguish more or less jaw lengths than the three jaw lengths, as well as to distinguish reload shafts having various other jaw lengths. Furthermore, in other embodiments, the shaft recognition mechanism can be configured to distinguish other shaft attributes, such as jaw shape (e.g., linear, curved, or circular laparoscope), different versions of the reload shaft (e.g., if the shaft mechanism, hardware components, materials, and / or shape are revised during the development of different versions of the reload shaft), or other shaft attributes for which it is desirable to provide a corresponding operating profile.

[0050] In some embodiments, the electric handle is connected to the reload shaft via mechanical components in a coupler 46 (Figures 1-2). The control system within the electric handle, further described with reference to Figures 45-46, interprets this connection process through position readings from an internal shaft recognition sensor 306 (Figure 19). In some embodiments, the shaft recognition sensor 306 includes a potentiometer. In some embodiments, the control system is configured to enter a shaft recognition state each time the device is turned on to determine whether the reload shaft is inserted. The shaft can be inserted before power is supplied to the device, but can only be considered recognized and authenticated when it first reaches a position where the shaft is not present. The control system may be configured to disable the operation of the electric handle until the reload shaft is authenticated as “recognized”. The system shall enter an “unrecognized shaft” state if it cannot correctly authenticate the shaft.

[0051] Once the electric handle is deemed ready for use by the control system and the inserted reload shaft is authenticated as "recognized" by the shaft recognition mechanism, the control system can determine and assign position values ​​for the full travel of the working shaft that operates the jaw assembly for grasping, tissue dissection, and staple formation. Since the user can replace the shaft and this system may be damaged during surgery, the shaft recognition mechanism and related aspects of the control system undergo continuous checks throughout the device's lifespan.

[0052] The relevant aspects of this shaft recognition mechanism and control system are advantageous in facilitating reliable staple firing of reload shafts with various jaw shapes. Misinterpreting the length of the shaft jaw assembly can result in no staple being formed, deformed staples, or damage to the jaw assembly, thus potentially damaging the device if a misrecognized shaft connection is interpreted.

[0053] Figures 19B and 19C show embodiments of a reload shaft used in conjunction with a shaft recognition mechanism. Figure 19B is a side view of a reload shaft 20 having a proximal end 22 (Figures 1-2) configured to couple with a coupler 46 of a handle assembly. Figure 19C is a detailed perspective view of the proximal end 22 of the reload shaft 20 having a lockout keyway 310 inside. At least one identification notch 312 is formed within the lockout keyway 310 to facilitate recognition of the shaft jaw assembly by the shaft recognition mechanism.

[0054] Figure 19D shows exemplary embodiments of three lockout keyways 310, 314, and 316. The illustrated lockout keyways 310, 314, and 316 each have the same overall height H to the proximal edge, but the depths of the identification notches 312, 318, and 320 are each unique. Each lockout keyway includes an inclined edge extending between the proximal edge and at least one side of the identification notches 312, 318, and 320. Each lockout keyway further includes a key, such as a rib 322, which restricts the rotation of the lockout keyway relative to the reload shaft when the reload shaft is coupled to the handle assembly.

[0055] Figure 19E shows an exemplary lockout sleeve 302 of the shaft recognition mechanism of an electric handle. In the illustrated embodiment, the lockout sleeve 302 includes an engagement feature, such as a flange 332 at its proximal end, and at least one rib 334 or other key element that protrudes from the outer surface of the flange 332 and maintains the orientation of the lockout sleeve 302 with respect to the longitudinal axis of the operating shaft. As shown, the lockout sleeve 302 further includes at least one mating protrusion, such as a tooth 336, which extends distally from the distal end of the lockout sleeve 302 and is arranged to engage with a corresponding notch in the lockout keyway of the connected reload shaft. At least one tooth 336 may have a similarly inclined edge 338 so as to be able to matingly engage with an identification notch in the lockout keyway having an inclined edge. In the illustrated embodiment, the lockout sleeve 302 includes two teeth 336 positioned opposite each other at the distal end of the lockout sleeve 302 to engage with two corresponding identification notches. In other embodiments, it is assumed that the number and position of the mating features included in the lockout keyway and lockout sleeve of the shaft recognition mechanism can also be changed.

[0056] Figure 19F shows an exemplary sequence of interactions between the lockout sleeve 302 and the lockout keyway 310 when mounting a shaft to an electric handle. As shown in the figure, the shaft mounting sequence proceeds from left to right. In the left panel, as the shaft is positioned within the coupler 46 (Figure 1) of the handle assembly, the lockout sleeve 302 is oriented so that the teeth 336 are misaligned with the identification notch 312. The coupler 46 and the shaft engage in a bayonet connection that rotates around the longitudinal axis after the shaft advances longitudinally proximal to the handle. The center panel shows the proximal longitudinal movement in which the lockout sleeve 302 is displaced proximal to the handle as the rotational motion of the shaft brings the teeth 336 closer to alignment with the identification notch 312. The right panel shows the bayonet connection locked in place after the rotation of the shaft relative to the handle assembly is complete. As shown in the figure, when the shaft is coupled to the handle assembly, the teeth 336 of the lockout sleeve 302 engage with the identification notch 312 of the lockout keyway 310 and are positioned inside it. Thus, during coupling, the lockout sleeve 302 is initially displaced proximal due to the mounting of the shaft with its teeth misaligned with the identification notch, and then returns distally as the teeth 336 engage with the identification notch.

[0057] Figures 19G to 19H show an exemplary series of interactions between the lockout sleeve 302 and the lockout keyway 310 when the shaft 20 is attached to the electric handle. In Figure 19G, the proximal end 22 of the shaft seats within the coupler 46 of the handle, and the teeth 336 on the lockout sleeve 302 advance proximal to align with the identification notch 312 of the lockout keyway 310. In Figure 19H, as the bayonet coupling occurs, the shaft 20 and the lockout keyway 310 rotate around the longitudinal axis of the shaft, causing the teeth 336 of the lockout sleeve 302 to nest within the identification notch 312 of the lockout keyway 310. In the illustrated embodiment, the lockout sleeve 302 is biased distally by a spring 340 to maintain the engagement of the teeth 336 with the identification notch 312. The lockout sleeve 302 has at least one lockout at the flange 332 of the lockout sleeve arm Joined to 304. Lockout. arm A rack located in one of the 304 engages with the pinion of the shaft recognition sensor 306. In some embodiments, the shaft recognition sensor includes a potentiometer. Thus, when the shaft is coupled to the handle assembly, the potentiometer locks out. Arm 304 Initially positioned in a first position corresponding to the initial proximal movement of the shaft, and then as the shaft rotates in the bayonet coupling, the potentiometer is positioned in a second position corresponding to the mating engagement between the teeth 336 of the lockout sleeve and the identification notch 312 of the lockout keyway 310. Thus, the depth of the identification notch determines the second position of the potentiometer.

[0058] Referring to Figure 19I, in some embodiments, a lockout includes a rack that engages with the shaft recognition sensor 306. arm 304 may include a bend 342 internally. The bend 342 reduces gear lash, thereby locking out arm It is desirable to enhance the meshing engagement between the rack 304 and the corresponding pinion of the shaft recognition sensor 306.

[0059] Referring to Figures 19J and 19K, in some embodiments, the electric handle system can be configured for use with different reload shaft assemblies having correspondingly different gripping and / or firing characteristics. For example, the electric handle system can be configured for use with three reload shaft assemblies, each having a different jaw assembly length. In these embodiments, the shaft recognition mechanism can be configured to recognize the presence of a reload shaft and that the shaft is a shaft recognizable by the control system of the electric handle assembly, by positioning the shaft recognition sensor 306 in three different position ranges. Figure 19J schematically shows the shaft recognition sensor 306 on the printed circuit board 144 of the electric stapler handle, identifying angular position ranges of several recognition zones.

[0060] Continuing with reference to Figures 19J and 19K, in some embodiments, the shaft recognition sensor 306 includes a potentiometer that includes a variable resistor whose voltage can be correlated to the angular displacement of an input member. In some embodiments, the potentiometer may have an angular operating window of about 330 degrees and a blind spot of 30 degrees. In some embodiments, the control system of the electric handle may include a shaft recognition module that assigns state criteria to a plurality of subdivided ranges within the operating window of the potentiometer, each representing the positioning of the potentiometer by the shaft recognition mechanism. In some embodiments, the shaft recognition module may be configured to distinguish the positioning of the potentiometer in at least a shaft detection zone and a plurality of recognition zones, each corresponding to the coupling of a recognizable reload shaft and handle assembly. In other embodiments, the shaft recognition module may be configured to distinguish a shaft type, a shaft version, or another shaft attribute, which is desirable to have a corresponding operating profile. The shaft recognition module may be further configured to distinguish a no-shaft zone indicating the absence of a reload shaft coupled to the electric handle, and a plurality of gap zones between the shaft recognition zones, in order to improve the recognition accuracy of recognizable reload shafts and identify misalignments in the coupling of the reload shaft.

[0061] During use, the shaft recognition module in the control system can be configured to monitor whether the shaft recognition potentiometer, upon detection in the detection zone, is located within a first predetermined time between the shaftless zone (indicating that the reload shaft is separated from the electric handle) or the recognition zone (indicating that it is coupled with a recognizable reload shaft). Once the shaft recognition mechanism places the potentiometer in the recognition zone, the shaft recognition module can monitor whether the potentiometer's position is away from the recognition zone for a second predetermined time, longer than the first predetermined time, to allow for a greater range of operation during use of the stapling system. The shaft recognition module can detect the presence of the potentiometer in a position corresponding to a predetermined gap between recognition zones or between a recognition zone and a detection zone, and if the potentiometer's position does not move out of the gap within a third predetermined time, it can disable the handle by configuring the control system to a shaft-unrecognized state and trigger a user alarm or alert, as further described with reference to the optical ring user indicators in Figures 42-44.

[0062] The shaft recognition mechanism can be configured to position the potentiometer in one of three discrete recognition zones 350, 352, and 354 when a reloadable shaft recognizable by the shaft recognition mechanism is coupled to the electric handle. As described above with reference to Figures 19G and 19H, once a recognizable reloadable shaft is mounted, the shaft recognition mechanism is further configured to position the potentiometer in the shaft detection zone 356 corresponding to the initial proximal movement of the lockout sleeve 302 before the potentiometer is positioned in the recognition zones 350, 352, and 354. The gap 360 between the recognition zones can enhance the operation of the shaft recognition mechanism and the shaft recognition module.

[0063] Figure 19K shows a schematic diagram of an embodiment of the arrangement of various zones recognizable by the shaft recognition module of the control system. In the schematic diagram shown, the shaft recognition module further includes a shaftless zone 362. When the shaft is not connected to the handle assembly, the lockout sleeve can be biased to position the shaft recognition mechanism with the potentiometer in the shaftless zone. In some embodiments, the shaft recognition module may report a shaft unrecognized state if the potentiometer is not present in the shaftless zone 362 when the handle assembly is first turned on. Furthermore, when the reload shaft is separated from and removed from the handle assembly, the shaft recognition module verifies that the potentiometer entered the shaft detection zone 356 and then entered the shaftless zone 362 for a predetermined period of time. The arrangement of zones in the shaft recognition module may also further include a maximum extension zone beyond the shaft detection zone. If the potentiometer advances into the maximum extension zone, it may indicate a hardware failure of the shaft recognition mechanism or an attempt to connect an unrecognized reload shaft, and the shaft recognition module may report an alert or error state to the control system.

[0064] Referring to Figure 19K, in the illustrated arrangement of recognition zones, it is desirable that the positions of the shaft detection zones and recognition zones within the shaft recognition design be ordered from the shortest jaw assembly length to the longest jaw assembly length adjacent to the shaft detection zone, so that the shaft recognition module is less likely to mistake a long shaft for a short shaft. Accordingly, as shown in the illustration, the shaft recognition mechanism and shaft recognition module are configured to reduce the risk of incomplete firing of reload shafts with relatively long jaw assemblies.

[0065] Manual override taking system Figures 20 to 27 show embodiments of the manual return mechanism for the electric handle. The manual return mechanism can advantageously provide a redundant return mechanism in the event of power supply failure, failure of other power components, or mechanical failure or locking.

[0066] Referring to Figures 20 to 25, the manual return mechanism includes three separate, independently operable subassemblies that are operated sequentially to return the operating shaft 120 to the nearest position within the handle corresponding to the open configuration of the jaw assembly. As shown, the manual return mechanism 170 includes a return locking mechanism, a shaft rotation mechanism, and a shaft retraction mechanism. Figure 20 shows the motorized handle in motorized operation mode with the return locking mechanism in the locked configuration. If it is desirable to manually return the stapler to the open configuration during operation, the return locking mechanism is first activated to unlock the manual return mechanism.

[0067] As shown in Figures 21 and 22, to activate the return lock mechanism, the return lock 171 is first slid proximally against the housing of the handle assembly. This movement of the return lock 171 unlocks the shaft rotation mechanism and the shaft retraction mechanism. In the illustrated embodiment, the return lock 171 moves from a position that was obstructing the movement of the shaft rotation mechanism, exposing it for use. At the same time, the return lock 171 is released from the lock projection 173 or tab on the shaft retraction mechanism, allowing the shaft retraction mechanism to pivot away from the handle assembly. When the return lock slides proximally, the lever of the shaft retraction mechanism is biased to move away from the handle assembly, allowing it to pivot away from the handle assembly.

[0068] As can be seen with reference to Figures 23 and 24, the return lock 171, when slid proximal to unlock the return mechanism, electrically couples to the control device of the handle assembly, thereby stopping the handle assembly. Therefore, once the return lock mechanism is operated, the handle can be made unusable, even if the user attempts to manually reposition it for repeated use of the manual return mechanism and drive system. In the illustrated embodiment, when the handle assembly is configured to be electrically operated (Figure 23), the return lock is electrically released from the circuit board 144 having the control device. When the return lock slides proximal to unlock the return mechanism, it moves a stamped spring component 175, which electrically engages with the circuit on the circuit board 144, in the proximal direction, stopping the handle assembly. The spring component 175 is configured to move only in the proximal direction and not in the distal direction, even if the return lock returns distally towards its initial position. Therefore, when the return mechanism is unlocked by sliding the return lock 171, the electric function of the handle assembly is permanently disabled.

[0069] As can be seen with reference to Figures 25 and 26, the user rotates a rotating lever 172, which extends over the outer surface of the handle and is not obstructed at this point by the movement of the return lock, in order to operate the shaft rotation mechanism of the manual return mechanism 170. The rotating lever 172 is coupled to a shaft rotation collar that is rotatably coupled to the actuating shaft. In the illustrated embodiment, the actuating shaft 120 is slidable through the shaft rotation collar 176. Therefore, when the shaft rotation collar 176 is rotated, the actuating shaft 120 rotates about 90 degrees around its longitudinal axis. This rotation places the rack 122 of the actuating shaft in a position that disengages it from the auxiliary gear 116 of the drive system. Since the actuating shaft 120 is rotatably coupled to the actuating adapter (Figure 5), this rotation can be performed without affecting the actuating adapter.

[0070] The illustrated embodiment includes a shaft rotation mechanism having a rotation lever 172 that is rotated by the user, but in other embodiments, the shaft rotation mechanism may be configured to self-deploy when the return lock moves proximally. For example, a self-deploying shaft rotation mechanism may include a shaft rotation collar having a torsional bias. In some embodiments, the shaft rotation collar is coupled to the handle assembly by a torsion spring. When the return lock slides proximally, the torsional bias of the shaft rotation causes the actuation rack to rotate, disengaging from the auxiliary gear and making it easier to engage with the shaft retraction mechanism.

[0071] As can be seen with reference to Figures 26 and 27, when the shaft rotation mechanism is operated, the shaft retraction mechanism operates to return the operating shaft proximal to the handle. Sliding the return lock proximal to the handle assembly unlocks the return lever 180 on the electric handle. The return lever 180 is pivotally coupled to the return pawl 182 at the pivot joint 184. The rack 122 of the operating shaft 120 rotates and engages with the shaft retraction mechanism when it rotates and is released from engagement with the drive system. The return lever 180 rotates once or through a series of return cycles (Figures 26 and 27) to engage the return pawl 182 with the rack 122 on the operating shaft 120, allowing the operating shaft 120 to retract proximal to the handle in a ratchet-like motion.

[0072] As can be seen with reference to Figures 27A to 27C, the return pawl 182 can be configured to facilitate the retraction of the operating shaft. In the illustrated embodiment, the return pawl 182 includes a protruding boss or second pawl tooth 183 positioned to interact with the guide member 127 of the motor mount during a portion of the return cycle. During the electric operation of the handle assembly, the second pawl tooth 183 contacts the guide member 127 to restrict the return pawl 182 from engaging with the rack 122 of the operating shaft 120 (Figure 27B). During the operation of the manual return mechanism, it is desirable that the second pawl tooth 183 be positioned to restrict the engagement of the return pawl 182 with the rack 122 during a portion of the return cycle, otherwise the user would have a relatively low mechanical magnification. As shown in the figure, the second claw teeth 183 prevent the return claw 182 from engaging with the rack 122 until the return lever 180 is positioned at a predetermined angle with respect to the longitudinal axis of the operating shaft 120 to obtain the desired mechanical magnification (Figure 27C).

[0073] Figures 28 to 31 show another embodiment of the manual return mechanism for the electric handle. The components and operation of the manual return mechanism 170' are the same as those described above for the manual return mechanism 170 in Figures 20 to 27. However, when using the manual return mechanism 170', the functions of the return lock and shaft rotation mechanism can be provided by a worm gear-driven shaft rotation collar 176'. Thus, the user can first rotate the actuation shaft 120 away from the electric drive system by rotating the worm gear drive, for example, using a hexagonal key. The shaft rotation mechanism releases the shaft retraction mechanism through the rotation of the worm gear, disengaging the actuation rack from the electric drive and positioning the actuation rack to engage with the shaft retraction mechanism (Figure 31). The shaft retraction mechanism of the manual return mechanism 170' includes a ratchet-type operation similar to that described above for the manual return mechanism 170, in which the return lever 180' is pivotably coupled to the return pawl 182'.

[0074] Two-position lockout mechanism Figure 32 shows a reload cartridge 250 used with an elongated shaft of a surgical stapler device having an independent empty jaw assembly and a fired reload lockout mechanism. As will be further described below, if the user attempts to grasp the jaw assembly in an open-close stroke without a reload cartridge 250 present in the jaw assembly, the two-position lockout lever moves to a first locked position. As shown, the reload cartridge includes a first lockout actuator sized and positioned such that the two-position lockout lever is positioned in a second position that defeats the empty jaw assembly lockout mechanism when the reload is located within the reload support of the jaw assembly. The first lockout actuator may include a ramped boss 252 extending laterally inward from the side wall of the cartridge body.

[0075] Continuing to refer to Figure 32, in the illustrated embodiment, the reload cartridge 250 includes a second lockout actuator of a size and configuration such that a two-position lockout lever is positioned in an unlocked position, which disables the fired reload lockout mechanism when an unfired reload is located within the jaw assembly. Thus, the two-position lockout lever can pivot to an unlocked position in addition to the two lockout positions. In some embodiments, the second lockout actuator includes a tail 254 extending proximal to the slider 255 of the reload cartridge 250. When the reload cartridge 250 is unfired, the slider 255 is in a proximal position such that the slider tail 254 extends proximal to engage with the lockout lever. As the firing member moves distally in its firing stroke, it contacts the slider in the reload cartridge, causing the slider to advance distally. Therefore, when the reload cartridge 250 is partially (or fully) fired, the slider tail 254 extending in the proximal direction is no longer in a position to disable the fired reload lockout mechanism.

[0076] Figure 33 shows a firing beam 226 used with an elongated shaft assembly of a surgical stapler device having an independent empty jaw assembly and a fired reload lockout mechanism. The firing beam 226 extends from a proximal end to a distal end 230. A firing member 240 having a roughly I-shaped beam configuration is positioned at the distal end 230 of the firing beam 226. The upper and lower horizontal flanges 242, 244 of the I-beam firing member 240 ride on the channels of the first and second jaws of the jaw assembly to bring the jaws closer together and maintain the spacing between the jaws during subsequent staple firing. A cutting blade 245 is positioned on the vertical portion of the I-beam profile to cut tissue between rows of staples. The I-beam firing member 240 can be attached to the distal end of the firing beam 226 by interlock fit, welding, another joining method, or any combination thereof. The proximal edge of the I-beam launch member 240 may have a proximal projection or tail 247 that can rest on the proximal portion of the lockout lever when the launch beam 226 is in a fully retracted position corresponding to the open jaw assembly.

[0077] Continuing to refer to Figure 33, the launch beam may include a first lockout notch 222 used with an empty jaw assembly lockout mechanism and a second lockout notch 224 used with a fired reload lockout mechanism. In the illustrated embodiment, the first lockout notch 222 extends by a first height from the adjacent lower edge 220 of the launch beam 226. As will be further described below, the first height is selected to correspond to the height of the proximal end of the lockout lever when the empty jaw assembly lockout is activated by an attempt to bring the jaw assembly closer in the absence of a reload cartridge.

[0078] Continuing to refer to Figure 33, in the illustrated embodiment, the second lockout notch 224 is located on the launch beam proximal to the first lockout notch 222. The second lockout notch 224 extends by a second height from the adjacent lower edge 220 of the launch beam 226. As will be further described below, the second height is selected to correspond to the height of the proximal end of the lockout lever when the fired reload lockout mechanism is activated by an attempt to fire a previously fired or partially fired reload.

[0079] In the illustrated embodiment of the launch beam 226, by having substantially continuous first lockout notches 222 and second lockout notches 224, the adjacent lower edges 220 of the launch beam are reduced over the longitudinal distance corresponding to the first lockout notches 222 and second lockout notches 224. In other embodiments, it is conceivable that the first and second lockout notches can be spaced apart from each other by an unreduced segment of the lower edge of the launch beam. As will be further described below, the height and longitudinal position of the first and second lockout notches can be configured to achieve desired operating characteristics of the stapler handle assembly.

[0080] Figures 34 and 35 show a partial exploded view (Figure 34) and a cutaway side view (Figure 35) of a portion of a jaw assembly 270 with various components concealed for the purpose of illustrating an empty jaw assembly lockout mechanism and a fired reload lockout mechanism. In some embodiments, the lockout mechanism includes a two-position lockout lever 280, a biasing spring 290, a first lockout notch 222, and a second lockout notch 224. The three-position lockout lever 280 has a distal end 282 configured to engage with a first lockout actuator and a second lockout actuator on a reload cartridge, a pivot shaft 284 adjacent to the distal end, and a proximal end 286 configured to engage with either the first lockout notch or the second lockout notch, or not to engage with either. The biasing spring 290 has at least one lower spring arm 292 that biases the distal end of the lockout lever 280 on the pivot shaft 284 downward toward the reload support of the second jaw 274. In the illustrated embodiment, the biasing spring has two lower spring arms 292, with a gap between them through which the launch member 240 and the launch beam 226 can pass. The biasing spring 290 may have at least one upper spring arm 294 that biases the first jaw 272 toward an open configuration. The biasing spring 290 may be configured to straddle the launch beam 226 and may have a central saddle member from which at least one lower spring arm 292 and at least one upper spring arm 294 extend.

[0081] Figures 36 to 41 show the operation of two lockout mechanisms. In the partial cutaway side views of the proximal end of some embodiments of these jaw assemblies, some elements of the jaw assembly (such as biasing springs) are not shown, and some components (such as the firing member 240) are shown as transparent elements to improve visibility of the operation of the lockout mechanism. Figures 36 to 39 show the function of the lockout mechanism when a fully unfired staple reload 250 cartridge is located within the reload support of the second jaw 274. Figure 40 shows the operation of the fired reload lockout mechanism. Figure 41 shows the operation of the empty jaw assembly lockout mechanism.

[0082] Figure 36 shows a cutaway of the proximal end of the jaw assembly. The jaw assembly is in an open configuration such that the first jaw 272 is biased to an open position relative to the second jaw 274. The launch member 240 and launch beam 226 are in a fully retracted position in the proximal direction such that the proximal face of the lockout lever 280 rests on the tail portion 247 extending proximal to the launch member 240. As a result, the distal end 282 of the lockout lever 280 rises slightly away from the reload support, allowing the lockout actuator to be positioned between the reload support and the lockout lever 280.

[0083] Continuing to refer to Figure 36, the distal end 282 of the lockout lever 280 rises slightly to receive the inclined proximal surface or inclined boss 252 of the first lockout actuator formed on the reload cartridge body. The distal end 282 of the lockout lever 280 has a lateral extension 283 (Figure 34) positioned to engage with the first lockout actuator when the reload cartridge 250 slides proximal when the jaw assembly is inserted into the reload support, and an inner surface 281 (Figure 34) positioned to engage with the second lockout actuator.

[0084] Figure 37 shows a cutaway of the proximal end of the jaw assembly with a partially inserted reload 250 cartridge. As shown, the lateral extension 283 of the distal end 282 of the lockout lever 280 engages with the inclined proximal surface 283 of the inclined boss 252. As the reload 250 cartridge slides further proximal, the lateral extension 283 rises its inclined surface to a first height relative to the reload support, pivoting the lockout lever 280 to a second position and disabling the empty jaw assembly lockout mechanism. The operation of the empty jaw assembly lockout mechanism will be further described below with reference to Figure 41. In the illustrated embodiment, when the distal end 282 of the lockout lever 280 is raised to a first height from the reload support by the first lockout actuator, the second lockout actuator or slider tail 254 of the unfired reload 250 cartridge is positioned at a height immediately distal to the first lockout actuator, so as to engage with the inner surface 281 of the distal end 282 of the lockout lever 280. Thus, when viewed in a cutaway side view as shown in Figure 37, the first and second lockout actuators define a progressive ramped profile configured to raise the distal end 282 of the lockout lever 280 to two predetermined positions when the reload 250 cartridge is inserted into the reload support.

[0085] Figure 38 shows a cutaway of the proximal end of the jaw assembly with the reload 250 cartridge nearly fully inserted. As shown, the inner surface 281 of the distal end 282 of the lockout lever 280 engages with the inclined proximal surface of the second lockout actuator or slider tail 254. In the illustrated embodiment, the tail 254 extending proximal to the slider of the reload 250 has a lead-in ramped surface that engages with the distal end 282 of the lockout lever 280 when the reload cartridge is unfired. In some embodiments, the lockout lever 280 and the slider tail 254 can be configured to enable smooth, relatively low-friction reload insertion, reducing the possibility of the slider becoming trapped or unintentionally advancing during cartridge insertion. For example, in some embodiments, the inner surface 281 of the distal end 282 of the lockout lever 280 may have a rounded distal end so that the lockout lever 280 pivots by interaction with the slider tail despite the possibility of slight angular misalignment between the reload 250 cartridge and the reload support. Furthermore, in some embodiments, the inclined proximal surface of the slider tail 254 may extend from a first height relative to the reload support at a proximal end lower than the height of the first lockout actuator relative to the reload support. Thus, when an unfired reload 250 cartridge is located within the reload support, the distal end 282 of the lockout lever 280 can smoothly transition from the first lockout actuator to the second lockout actuator with a wide range of angular alignment between the reload cartridge and the reload support.

[0086] Figure 39 shows a cutaway of the proximal end of the jaw assembly with a fully inserted reload 250 cartridge. As shown, the inner surface 281 of the distal end 282 of the lockout lever 280 advances along the inclined proximal surface of the second lockout actuator or the slider tail 254. This advance along the inclined surface of the slider tail 254 causes the lockout lever 280 to pivot around the pivot axis 284, so that the distal end 282 of the lockout lever 280 is at a second height relative to the reload support. When the distal end of the lockout lever 280 is at the second height, the lockout lever is in the unlocked position corresponding to the unlocked state of the empty jaw assembly lockout mechanism and the unlocked state of the fired reload lockout mechanism.

[0087] Continuing to refer to Figure 39, when the lockout lever 280 is in the unlocked position, the proximal end 286 of the lockout lever 280 is positioned lower than the lower edge of the firing beam. Thus, the firing member 240 and the firing beam 226 can advance distally through the opening / closing stroke and firing stroke in response to user input from a mechanically or electrically operated handle assembly (Figures 1 to 5) that is operably coupled. Thus, when an unfired reload cartridge is inserted into the reload support of the jaw assembly, both the empty jaw assembly lockout mechanism and the fired reload lockout mechanism are deactivated, allowing the user to operate the stapler handle assembly to grasp tissue with the jaw assembly and fire staples from the jaw assembly by translating the firing beam and firing member distally within the jaw assembly.

[0088] As can be seen with reference to Figure 40, when the reload 250 cartridge is at least partially fired, the slider within the reload 250 advances distally from its proximal unfired position. Once the firing stroke is complete, with the slider remaining in the distal position within the reload cartridge, the firing beam 226 and firing member 240 can be retracted proximal in response to operation of the handle assembly in a return or retraction stroke. Thus, when the reload 250 cartridge is partially or completely fired, the second lockout actuator or slider tail is no longer in a position to engage with the distal end 282 of the lockout lever 280. However, in some embodiments, the first lockout actuator or inclined boss 252 is fixed to the body of the cartridge. Thus, when the partially or completely fired reload 250 is located within the reload support, the first lockout actuator engages with the distal end 282 of the lockout lever 280, positioning the distal end 282 of the lockout lever 280 at a first height relative to the reload support. When the distal end 282 of the lockout lever 280 reaches a first height corresponding to the second position of the lockout lever, the empty jaw assembly lockout mechanism is deactivated, but the fired reload lockout mechanism is locked.

[0089] Continuing to refer to Figure 40, when the lockout lever 280 is in the second position, the proximal end 286 of the lockout lever 280 is at a height corresponding to the second lockout notch 224 on the firing beam 226. Furthermore, in some embodiments, a biasing spring 290 (Figure 34) exerts force on the upper surface of the distal end 282 of the lockout lever 280, making it easier to maintain the proximal end 286 of the lockout lever 280 at a height corresponding to the second lockout notch 224 on the firing beam 226. Thus, if a user attempts to operate the jaw assembly while a fired reload cartridge is present in the jaw assembly, the firing beam 226 can advance distally until the proximal end 286 of the lockout lever 280 is accommodated within the second lockout notch 224 of the firing beam 226, indicating engagement of the fired reload lockout mechanism and preventing further distal movement of the firing beam and firing member.

[0090] Continuing to refer to Figure 40, in some embodiments, the fired reload lockout mechanism can be configured to allow operation of the stapling device's jaw assembly for at least a portion of its opening and closing stroke. For example, in some embodiments, the position of the second lockout notch 224 and the length of the lockout lever 280 can be sized and configured such that the firing beam 226 is arrested when the fired reload mechanism engages in a position corresponding to a fully closed or nearly fully closed configuration of the jaw assembly. In such a jaw assembly configuration, the firing member 240 maintains the cutting edge 245 in a substantially retracted position even if it advances to a distal position that brings the first and second jaws closer together. A fired reload lockout configured to allow an opening and closing stroke has the advantage that, after firing staples from a reload cartridge, the user can operate the jaw assembly for one or more opening and closing strokes to evaluate the thickness and consistency of the tissue at various positions where a potential second reload may be applied. Similarly, insertion of stapling devices through surgical access ports such as trocars may generally require the jaw assembly to be in a closed configuration, allowing the user to retract and reinsert the jaw assembly through one or more surgical access ports to evaluate the thickness and consistency of the tissue at various locations within the surgical site.

[0091] Continuing with reference to Figure 40, in some embodiments, the fired reload lockout mechanism can be further configured to prevent the operation of the stapling device during the firing stroke. A mechanical electric stapler handle assembly, typically configured for use with the elongated shaft and jaw assemblies described herein, such as those described with reference to Figures 1 to 5, includes a firing mode selector mechanism or firing safety switch that allows the user to actively select the firing stroke operation of the jaw assembly only when the jaw assembly is in a closed configuration. Thus, in some embodiments, the position of the second lockout notch 224 and the length of the lockout lever 280 can be sized and configured such that the firing beam 226 stops when the fired reload lockout mechanism is engaged in a position corresponding to the position of the jaw assembly near the fully closed configuration. Thus, in these embodiments, when the fired reload lockout mechanism is engaged, the user is unable to select the firing stroke operation on the handle assembly. The operation of the fired reload lockout mechanism that prevents the selection of the firing stroke on the handle assembly is advantageous as it serves to indicate to the user that the lockout has been engaged.

[0092] Figure 41 shows a cutaway of the proximal end of the jaw assembly with no reload cartridge inserted and the launch member and launch beam slightly advanced longitudinally. When no reload is present, as the tail 247 of the launch member 240 advances from the proximal end 286 of the lockout lever 280, the biasing spring 290 (Figure 34) exerts force toward the reload support on the upper surface of the distal end 282 of the lockout lever 280. Thus, when the launch beam 226 first advances in response to the user operating the handle assembly to advance the jaw assembly in an opening and closing stroke, the lockout lever 280 pivots to a first position corresponding to the locked configuration of the empty jaw assembly lockout mechanism. As the launch beam 226 advances distally, the proximal end 286 of the lockout lever 280 is accommodated in the first lockout notch 222 on the launch beam 226 and engages with the empty jaw assembly lockout mechanism, preventing further distal translation of the launch beam 226 and the launch member 240.

[0093] Continuing to refer to Figure 41, in some embodiments, the empty jaw assembly lockout mechanism can be configured to stop the movement of the launch beam in a position corresponding to a substantially open configuration of the jaw assembly. For example, the position of the first lockout notch 222 on the launch beam 226, the length of the lockout lever 280, and the length of the tail portion 247 of the launch member 240 can be sized and configured such that the empty reload lockout mechanism locks in the initial part of the opening and closing stroke of the jaw assembly. When the empty jaw assembly lockout mechanism is configured to lock in the initial part of the opening and closing stroke, there is an advantage that the jaw assembly cannot be closed enough for the user to operate the handle assembly and insert it through the surgical access port if there is no reload cartridge in the jaw assembly. Thus, when the empty jaw assembly lockout mechanism is configured in this way, the user can get tactile indication that there is no reload cartridge in the jaw assembly before accidentally introducing an empty jaw assembly to the surgical site. Furthermore, it is desirable that such an empty jaw assembly lockout maintains the cutting edge 245 of the launch member 240 in a substantially retracted, shielded position for jaw assemblies in which there is no reload.

[0094] Light Ring User Display In some embodiments, the handle assembly may include a control device that processes operational data, including information regarding firing difficulty, test time, and device status, and optionally stores or saves it in a memory module. Therefore, it is desirable that the stapler include a user display that communicates specific operational information to the surgeon so that the surgeon can make intelligent decisions regarding the firing they are about to perform. For example, in some cases, it is desirable to provide the user with some information regarding the clamping time and whether the thickness of the clamped tissue is suitable for stapling within the operational parameters of the staple reload cartridge at the stapler's end effector.

[0095] Referring to Figure 42, in some embodiments, the handle assembly may include a multifunctional illuminated display as a user display, such as an annular illuminated "light ring" user display subassembly 402. During surgical procedures, the handle assembly is repositioned and operated in various angular directions, so the annular configuration of the light ring subassembly is advantageous in providing a highly visible user display to the operator from any device orientation.

[0096] Referring to Figures 43-44, in the illustrated embodiment, the optical ring user display 402 includes an annular light reflector 404, an annular optical ring 406, and a plurality of light sources 408. The annular light reflector 404 is positioned radially inward of the annular optical ring 406 so that illumination from the light sources 408, which emit light radially inward, is reflected from the annular light reflector and propagates through the annular optical ring. The material of the optical ring 406 can be selected to control light dispersion so that external bright spots are not visible to the user while enabling high light transmittance. As shown, the user display 402 includes four light sources 408 spaced substantially equally apart around the optical ring user display 402. In some embodiments, each of these light sources may include an RGB light-emitting diode capable of illuminating in various colors and luminances. The optical ring user display 402 can be electrically coupled to a control device of a handle assembly, such as a circuit board on a flexible printed circuit board, such as a Rigid Flex printed circuit board. As shown in the figure, the flexible printed circuit board 410 can be formed in an annular configuration and placed between the annular optical ring 406 and the annular optical reflector 404. The light source 408 can be mounted on the inner surface of the flexible electrical cable 410 so as to emit light radially inward toward the annular optical reflector 404. It is desirable that the shape of the flexible printed circuit board and the housing reflector be such that the light source can be easily held at any angle that maximizes reflected light and minimizes bright spots.

[0097] While one embodiment of the optical ring user display 402 has been illustrated and described above, it is assumed that other embodiments of the optical ring user display may include other aspects. For example, in some embodiments, more or fewer than four light sources 408 may be used within the optical ring user display, and different or further illumination techniques may be used. In some embodiments, light sources may be placed on the outer surface of the flexible electrical cable 410 so that they emit light directly through the annular optical ring 406 without including an annular light reflector in the optical ring user display. In other embodiments, light can be emitted from the light sources without using a separate annular optical ring by using a surface formed on one or both halves of the housing of the handle assembly.

[0098] As can be seen with reference to Figure 42, the optical ring user display 402 is assumed to be electrically coupled to a control device and configured to display various status messages to the user. For example, color, brightness, flashing sequence, or steady on / off illumination can be controlled to convey desired information to the user. In some embodiments, information can also be conveyed to the user using the occurrence and / or speed of specific color or brightness transitions. In some display control profiles, a first color can be used to indicate that the handle is in open-to-clamp functionality, where firing is not possible, and a second color can be used to indicate that the stapler is in firing mode, configured to fire staples. Further colors or other indicators can also be used to represent other events or operating states of the stapler, such as completion of firing, reversal of the firing mechanism, and occurrence of firing errors.

[0099] In some embodiments, the user display of the electric handle includes two groups of RGB LEDs: (1) a status indicator and (2) an LED ring. The status indicator is an "always-on" light that indicates to the user that sufficient power is being properly supplied to the microcontroller. Thus, the status indicator can quickly show the user whether the electric handle is "off" or "on".

[0100] In embodiments having separate status indicators and LED rings, the status indicators can be RGB LED assemblies, currently available on the market as Sun LED part number XZFBBM2ACRDG92W-3, and the LED rings can contain up to four more of these RGB LED assemblies. In an exemplary circuit driving the status indicators and LED rings, each RGB LED assembly includes three shunt resistors, one corresponding to each color. The shunt resistors have the same value for each color on each RGB LED assembly. The shunt resistors are housed in 0603 packages, available up to 1 / 4 watt, so that the brightness can be changed by increasing or decreasing the current. The current to the RGB LED assemblies is controlled through MMBT2222A transistors, each having a 1.00 kΩ base, and all LEDs of the same color are controlled by a single transistor; therefore, the status indicators can include three transistors corresponding to their red, green, and blue LEDs, and the LED rings can include three transistors, each electrically coupled to all of their red, green, and blue LEDs.

[0101] In some embodiments, an LED ring is the primary user interface of the system, indicating the handle operating state determined by a light control scheme within the handle assembly's control system. Specific device states correlate with indicator color (white / blue / green / yellow / red / off), brightness, and load cycle. Operators and assistants are instructed to use the indicators provided via the LEDs for setting up, using, and troubleshooting the device. An LED ring positioned at the proximal end of the handle assembly and extending radially around the handle is advantageous in clearly indicating the status of the motorized handle to the operator and other members of the surgical staff, regardless of the handle's orientation relative to the surgical site. Previous staplers in this field have been known to be difficult to see in certain orientations due to excessive indications placed in one location, making them difficult for users and other medical personnel to interpret. In contrast, an LED indicator system coupled with a light control scheme (status machine / alarm table) clearly and simply indicates all necessary device operating states.

[0102] The optical control scheme can be configured to warn the user of invalid manufacturing or calibration data, device damage, and / or incorrect settings before use in surgery. It is desirable that the optical control scheme and LED light ring enable the user to quickly troubleshoot and use the device by interpreting its status. An optical control scheme implemented in a control microcontroller is advantageous because it can achieve various brightness levels by switching each color on / off and modulating the pulse width of each color.

[0103] In some embodiments, the optical control scheme may apply a first indicator to indicate a user alarm condition in the electric handle system. For example, the first indicator may include the flashing of a red LED ring. In some embodiments, the user alarm condition may include an indication that the handle has exceeded a predetermined number of firings, an indication that power has been supplied to the handle for a predetermined time, or an indication that the battery life of the handle's battery is relatively short. Furthermore, the user alarm condition may also include an indication that the trigger appears not to have moved beyond a predetermined time threshold, the firing button appears not to have moved beyond a predetermined time threshold, the operating shaft position appears to be out of range or not changing, or the motor current exceeds a predetermined maximum limit. Furthermore, the user alarm condition may also include an indication that the manual reset mechanism has been activated, or that a hardware or control system failure has occurred. In addition to warning the user through the optical control scheme, the control system may also disable all handle functions when a user alarm condition occurs.

[0104] In some embodiments, the optical control scheme may display a second indicator to show the end-of-life state of the handle in an operating electric handle system. The second indicator may include solid red illumination of an LED ring. If an end-of-life state occurs in the handle assembly during operation, which may correspond to the completion of the maximum number of shots, the elapsed maximum power supply time, or battery depletion, the control system may warn the user of the handle's end-of-life state by having the optical control scheme display the second indicator, and may allow the handle assembly to operate in grip mode until the next power cycle, at which point the handle assembly may be disabled.

[0105] In some embodiments, the light control scheme may display a third indicator to indicate that user attention is desirable for the continuation of the stapling operation. The third indicator may include flashing yellow illumination of an LED ring. Certain instances of operation of the electric stapler may be advanced with further user input. For example, if the firing button or trigger is pressed for a duration shorter than a predetermined threshold indicating a button or trigger stack during a particular operation sequence, the third indicator may indicate to the user that the button or trigger should be released to allow the sequence to proceed. For example, if the trigger is pressed for a duration shorter than a threshold indicating a trigger stack when the reload shaft assembly is first loaded, when the jaws are fully closed before stapling, or when the stapler is fully fired, the light control scheme may display flashing yellow illumination of an LED ring to indicate to the user that the trigger should be released. If the firing button is pressed for a duration shorter than a threshold indicating a firing button stack when the jaw assembly is open or the device is ready to fire, the light control scheme may display flashing yellow illumination of an LED ring to indicate that the firing button should be released.

[0106] The light control scheme may further include a fourth indicator, including monochromatic yellow illumination of the LED ring, to indicate that further user intervention is desirable for the continuation of the stapling operation. For example, if a reload shaft assembly not recognized by the control system is installed, or if a motor current exceeding a predetermined high threshold occurs during jaw closure (indicating the presence of excessively thick or dense tissue or other items such as clips within the grasped specimen), or if reload shaft lockout is involved, the light control scheme may illuminate the LED ring in monochromatic yellow.

[0107] The light control scheme may further include additional indicators that show specific instances indicating that the handle assembly is functioning correctly. For example, in some embodiments, the light control scheme may illuminate an LED ring in monochromatic blue to indicate that tissue is gripped and the jaw assembly is locked in preparation for firing. If the jaw assembly is subsequently released, the light control scheme may illuminate the LED ring in flashing blue. If the firing operation is canceled, the light control scheme may illuminate the LED ring in flashing green.

[0108] control device As described above with respect to some features of the illustrated handle assembly, the handle assembly may further include a control unit. As shown in the illustration, the control unit may include a microcontroller electrically coupled to a circuit board electrically coupled with various additional sensors, power supply and user display components. The control unit may be configured to drive a motor to provide an open-clamp function and then a staple firing function in the stapler jaw assembly. The control unit may be further configured to modify the motor's operating parameters based on sensor data from one or more of the following: a motor load sensor, an actuation rack position sensor, a shaft recognition sensor and an articulation position sensor.

[0109] Figure 45A shows a schematic flowchart illustrating the data and power flow of an exemplary control system for an electric steering wheel. In the illustrated flowchart, the control system includes the illustrated microcontroller 502. In various embodiments, the microcontroller may include an application-specific integrated circuit or a general-purpose microcontroller running application-specific firmware and / or software. As shown, the microcontroller receives power and battery status data from the battery 504 in the power supply. The microcontroller further receives data from various mechanical hardware of the stapler, such as the motor driver 506, current monitor 508, actuation rack position sensing mechanism 510, and shaft connection and type monitor 512. As described above with respect to the joint movement mechanism, the microcontroller 502 may further receive joint movement position information from the joint movement position sensing mechanism 514. The microcontroller may further receive data from the user via the trigger position sensor 516 and push-button switches. The control system may output control signals to operate the drive system of the electric steering wheel through the motor driver 506. The control system can output some operational parameter information to a memory module 520, which in some embodiments may include a removable module, and can also output some data visible to the user through LED lighting 522 on the handle, such as the optical ring user display described herein. In some embodiments, the control system can be configured to provide the user with haptic feedback such that the user feels a tactile sensation but the position of the operating rack is not significantly affected, by means of operating an independent haptic module or a haptic generation motor drive profile that can instruct the motor rotation to make one or more small forward and reverse displacements. In some embodiments, the microcontroller can be configured to send and receive information wirelessly, for example, via Bluetooth, WiFi, or another wireless protocol.

[0110] In some embodiments, the control system is also configured to further define the operating parameters of the electric handle. For example, the control system can detect whether the electric handle has been used in more than one surgery by querying a memory module on the power supply or the control system itself. In some embodiments, the stapling system is designed for use in a single surgery and is not designed to be re-sterilized. The control system can also query the power supply or a memory module on the control system to detect the number of staples fired and evaluate whether there is enough battery power remaining to complete further firings.

[0111] In some embodiments, the control system may include one or more modules that address specific aspects of the operation of the electric handle. For example, the control system may include a shaft recognition module configured to recognize specific reload shaft characteristics and apply corresponding control signals to the motor, as described with reference to Figures 19B to 19K. In some embodiments, the control system may include a lockout control module that can be configured to detect when jaw assembly lockout is activated, as described with reference to Figures 47 to 53. Furthermore, the control system may include an optical control scheme for an optical ring display configured to provide a visual indicator to the user when a specific operating state occurs, as described with reference to Figures 42 to 44.

[0112] In some embodiments, the control system is configured to detect tissue characteristics that promote staple formation. In some embodiments, the control system is configured to detect tissue characteristics that may prevent staple firing. In some embodiments, the control system can monitor the position, speed, and torque supplied by the motor of the drive system. The control system can detect whether excessive time is required to close the jaw assembly, or whether excessive torque is required to close the jaw assembly if the jaws are closing at a slow speed. These conditions may indicate that the thickness or density of the tissue in the jaw assembly is too high for the stapler to be effective. In some embodiments, the control system can monitor the position of the operating shaft against time and evaluate this monitored position and time against a baseline "zero load" time reference position and time to assess tissue characteristics such as thickness and density. If the drive system exceeds predetermined operating parameters, the control system can indicate an error condition and stop the firing operation.

[0113] Referring to Figures 45B to 45F, in some embodiments, the control system may include an initialization module or a startup module. The startup module can verify that certain operating parameters of the handle assembly hardware, microcontroller, and memory are at predetermined values ​​or within predetermined ranges before the control system enables the handle assembly to operate in gripping and firing operations. Figure 45B shows an example process flow sequence of the starting portion of the startup module of the control system. The starting portion can be executed first by the control system when the handle assembly is powered on. During use, power-on operations can occur when a new handle assembly is powered on for the first time, when a previously used handle is powered on, or when the handle assembly experiences a loss of power during the operation sequence. In the illustrated example process flow sequence, the initial portion of the startup module enters one of the new handle submodule, used handle submodule, or reset detected submodule when evaluating certain initial parameters.

[0114] Referring to Figure 45B, the startup module initiation is executed by the microcontroller when the power is turned on. The initiation queries the operating parameters of the handle assembly (550a-550f). In various embodiments, the operating parameters can be stored in the microcontroller's memory registers or in a memory module on the printed circuit board. In the illustrated example, the operating parameters 550a-550f may indicate that the handle has previously encountered a hardware or control system failure that could prevent the operation of the handle assembly. For example, in the illustrated process flow, the operating parameters include stored values ​​for specific defined operating conditions, such as a data abort flag 550a, a watchdog failure flag 550b, a manual return flag 550c, a dead handle flag 550d, a battery voltage within a predetermined range 550e, and a microcontroller temperature within an operating range 550f. If any of the queried operating parameters 550a-550f do not return an operating value or a value within an operating range, the startup module initiation configures the control system into a critical startup error state. The operating parameters of battery voltage 550e and microcontroller temperature 550f can be reset in subsequent power cycles, but various flags indicating hardware or control system failures in other operating parameters 550a to 550d are stored during subsequent power cycles.

[0115] As can be seen with reference to Figure 45B, if all the queried operating parameters 550a to 550f return operable values, the startup part evaluates the handle state and selects the corresponding submodule of the startup module to be executed. The control system is configured to use a reset detection module to detect the occurrence of a power reset and to store a true value in a memory location when a reset is detected. The PCB may include a reset detection line electrically coupled to the control system. In the illustrated process flow, the control system may disable this reset detection module. Therefore, the startup part evaluates whether the reset detection module is enabled. If the reset detection module is enabled, the startup part queries the reset detection flag value to evaluate whether the handle assembly has been powered on after a transient power state that may have occurred due to a brief power interruption to the microcontroller or ambient electromagnetic interference. If the stored reset detection flag value indicates that a reset has occurred, the reset detected submodule 552 is selected for execution. If the reset detection module is disabled, or if the query flag of the reset detection module indicates that a reset has not occurred, the startup part queries a stored value indicating whether the handle has been used before. If the stored value indicates that the handle has been used previously, the used handle submodule 554 of the startup module is selected. If the stored value indicates that the handle has not been used previously, the new handle submodule 556 is selected.

[0116] Figure 45C schematically shows an example of the process flow of the first part of the new handle submodule 556. In the first part, the new handle submodule queries various operating parameters to evaluate whether the handle hardware and control system are operational. In the illustrated example, the new handle submodule can identify the presence of the external memory module 560a and record its value if it does not exist. The new handle submodule can query operating parameter values ​​to authenticate the handle device, including a valid device serial number 560b, a printed circuit board assembly (PCBA) lot number 560c, and a handle lot number 560d. If any of these operating parameters are invalid, the new handle submodule can set the control system to a critical startup error condition and set the dead handle flag value to true (because an indication of a dead handle flag with a true value during queries in the initial part of the startup module stops the startup operation), preventing power cycling and restarting of the handle. Next, the new handle module can verify certain hardware and control system operating parameters, including verifying that the device is properly calibrated 560e, 560f, 560g, that the motor is operational 560h, 560i, and that the operating shaft position sensor is within the activation range 560j. If any of these operating parameters are not valid, the new handle submodule can set a critical activation error condition in the control system and set the dead handle flag value to true to prevent power cycling and reuse of the handle. If all queried operating parameters 560a-560j are operational or within the operational range, the new handle submodule sets the control system to a power-on operating condition and starts the second part 562 of the new handle submodule.

[0117] Figure 45D shows an example of the process flow of the second part 562 of the new handle submodule. In the illustrated example, the second part 562 verifies that the handle is operational by querying the positions of the actuation shaft 565a, shaft recognition module 565b, joint motion sensor 565c, trigger 565d and firing button 565e, and motor operating characteristics 565f. If a specific position value or combination of position values ​​is returned when the second part of the new handle submodule performs a position query, the new handle submodule can identify a specific hardware failure, such as a trigger and actuation shaft position failure or a motor stall failure, and determine whether an unrecognized reload shaft is attached to the handle.

[0118] Figure 45E shows an example of the process flow of the Reset Detected submodule 552. In the illustrated example, if a reset has been previously detected, the Reset Detected submodule first queries whether the handle has previously completed its initial firing and therefore has used handle operating parameters. If the handle has been fired previously, the Reset Detected submodule queries the position of the actuarial shaft to determine the position of the actuarial shaft rack (564) and evaluates whether the jaws are in the fully closed position, the open position, the partially closed position, or the advanced position beyond the fully closed position. Next, the Reset Detected submodule returns the actuarial shaft to the position corresponding to the jaw opening (566). Next, the Reset Detected submodule queries the Shaft Recognition module to evaluate whether the recognized reload shaft is coupled to the handle assembly (568). If the handle has never been fired previously, the Reset Detected submodule 552 performs a similar process flow to determine the position of the actuarial shaft and returns the actuarial shaft to the position corresponding to the jaw opening, and then queries whether the recognized reload shaft is coupled to the handle assembly. Under certain conditions, the reset detected submodule 552 may further query (570) whether external memory exists and log the event (572).

[0119] Figure 45F shows an example of the process flow of the used handle submodule 554. When a used handle is detected, in the illustrated example, the used handle submodule queries the positions of the actuation shaft 574, the shaft recognition module 576, and the trigger 578 to verify that the handle is operational. If a specific position value or combination of position values ​​is returned when the used handle submodule performs the position query, the used handle submodule 554 can restrict the operation of the handle assembly and set the dead handle flag to true.

[0120] Figures 46A and 46B show block diagrams of the operation flowcharts of an exemplary firing sequence of the control system. As shown, the control system integrates user input from the trigger and firing button with hardware input from various sensors and monitors to advance the jaw assembly from a fully open state 530 to a fully closed state 532 for the firing sequence 534, and then back to the fully open state 530. Figure 46A shows the operation flowchart from the initial power-on state to the fully closed jaw state. Figure 46B shows the operation flowchart from the fully closed jaw state to the firing sequence. In one exemplary operation sequence, when the jaws are in the fully closed state 532, the control system can detect whether the trigger has been fully released (531). In another exemplary operation sequence, when the jaws are in the fully closed state, the control system can detect whether the firing button has been pressed (533). Once the firing sequence is complete, the control system can return the handle assembly 535 to the gripping configuration.

[0121] During the firing operation, the control unit can monitor the position of the actuarial shaft to be provided and provide a desired motor drive profile. In some embodiments, the microcontroller operates using a motor drive logic profile that identifies various operating zones of the actuarial rack position and can apply predetermined motor drive parameters, such as motor speed and motor load monitoring, for each of these zones and various actuarial rack positions within these zones. In some embodiments, the motor drive logic profile can be a software or firmware-based calculation program stored in a memory module, such as a computer-readable medium within the control unit or a computer-readable medium electrically coupled to the control unit. In some embodiments, the motor drive logic profile can define one or more operating parameters from gripping zones, lockout zones, firing zones, full firing zones, return zones, and release zones, and the sequence of operations through them. In some embodiments, the motor drive logic profile can be configured to adjust the relevant zones and several positions in response to sensor inputs received from one or more of the following: joint motion position sensors, shaft recognition sensors, motor load monitors, or other sensor inputs.

[0122] The gripping zone corresponds to the movement zone of the actuari rack between the jaw open position and the jaw clamped position of the end effector mounted on the instrument shaft. In this region, the microcontroller can be configured to drive the jaw assembly in proportion to the degree of trigger movement input by the user and transmitted to the microcontroller by a trigger position sensor such as a trigger potentiometer. When the trigger is fully pressed, the device advances the actuari shaft to a position where the jaws of the end effector are fully closed. When the trigger is fully released, the device returns to the jaw open position. When the trigger is fully pulled and the fire button is pressed simultaneously, the actuari shaft advances to the lockout zone. In other embodiments, in the gripping zone, the microcontroller can be configured to drive the motor in proportion to the displacement angle of the trigger, such that the jaw closing speed in the gripping zone is determined by the trigger movement, rather than the amount of jaw closure being determined by the trigger movement.

[0123] In some embodiments, the motor speed can be changed to a desired travel speed through pulse width modulation in a specific zone. In some embodiments, the motor can be pulse-width modulated at less than 100% load cycles in the gripping device zone. In some embodiments, it may be desirable to drive the motor at approximately 50% to 90% load cycles in the gripping device zone. In some embodiments, the motor drive logic profile can be configured so that the motor is pulse-width modulated at 70% load cycles in the gripping device zone.

[0124] In some embodiments of the control system, when the user presses the firing button on the handle, the control unit moves from the jaw closed position in the gripping instrument zone to a lockout zone in the motor-driven logic profile. The lockout zone can be configured to provide a motor control profile for the instrument shaft and jaw assembly that includes a firing lockout that prevents the stapler from firing if a fired stapler reload cartridge is present or absent. When this type of lockout is activated, the motor load can increase significantly because it prevents any part of the firing mechanism in the instrument shaft or jaw assembly from advancing further to a predetermined operating position of the actuator. Therefore, the control unit can monitor sensor information from the actuator rack position sensor and motor load sensor for expected spikes in motor load while in the lockout zone.

[0125] In some embodiments of the control system, rather than incorporating a separate lockout zone, the control system can monitor for the presence of a lockout when the handle assembly is in the gripping instrument zone. Thus, in some embodiments, the control system does not include a dedicated gripping instrument zone and continuously monitors whether a lockout exists within the gripping instrument zone. Such embodiments of the control system can facilitate indication of the presence of a lockout where the reload mechanism is clearly missing or used, as described with reference to Figures 33 to 41.

[0126] Lockout control module As described above, in some embodiments, the control system can be configured to monitor the current within a defined “lockout zone” of the actuator position. In these embodiments, the control system can determine the presence of lockout mechanism engagement based solely on a current threshold. In some embodiments, the current threshold is determined based on a sample at the start of the lockout zone plus a constant 300 mA indicating that reload lockout has not been disabled and the actuator movement has stopped. However, the one-factor lockout sensing module of this control system is most effective outside the gripping area when the actuator is approaching the firing stroke of the jaw assembly. The control system directs a constant PWM operation of the motor outside the gripping area. Furthermore, when the actuator advances distally beyond the gripping area, tissue clamping has already occurred, thus minimizing any potential current fluctuations due to variations in tissue thickness and consistency. However, the two-position lockout mechanism described above with reference to Figures 32-41 offers some operational advantages when engageable within the gripping instrument zone, which may necessitate further improvements to the lockout sensing module of the control system.

[0127] As described above with respect to Figures 32 to 41, it is desirable that the two-position lockout mechanism be able to engage at two different actuator positions corresponding to an empty jaw assembly and at least a partially fired reload. In some embodiments, the lockout notches formed in the firing beam can be substantially continuous so that these lockout actuator positions are relatively close to each other. Furthermore, in some embodiments, each of these actuator positions can be located within a gripping zone or region of the control system operation. In the gripping region, the control system can be configured to provide full user control of opening and closing the jaws of the jaw assembly before entering the firing state. The user can partially close, re-open, and re-close the jaws without restriction. In some embodiments, in the gripping region, the trigger is associated with proportional jaw closing, i.e., pulling the trigger 25% closes the jaws 25%. However, each time the user interrupts, opens, or closes the jaws, the motor stops and restarts. Further power is required for the motor to overcome inertia and ramp up to full speed, resulting in a large instantaneous current spike. Furthermore, since jaw assemblies typically compress tissue during jaw closure in the gripping area, the load on the motor increases in response to an increase in the thickness or density of the tissue located between the jaws. Consequently, in some cases, a lockout module in a control system based solely on current sensing may produce false positive indicators where one or more lockout mechanisms may engage at actuator positions within the gripping instrument area due to transient user input and tissue compression conditions.

[0128] Figures 47–52 show plots of exemplary current profiles 600, 601, 603, 605, 607, 609, and 611 of a power stapler under various operating conditions. These plots show the motor load or current draw (measured in milliamperes) tracked over operating time (measured in tens of milliseconds). Figure 47 shows plot 600 of an exemplary current profile of the gripping instrument region of an unloaded stapler (representing, for example, a substantially empty jaw assembly during a gripping operation). This plot includes an initial current spike 602 when the trigger is first pulled and the motor accelerates, followed by a relatively constant current region 604 as the motor operates at a relatively constant speed. Figure 48 shows plot 601 of an exemplary current profile of the gripping instrument region of a stapler with a relatively high load (representing, for example, the jaw assembly gripping a relatively thick tissue specimen during a gripping operation). This plot includes an initial current spike 606 when the trigger is first pulled and the motor accelerates, and a subsequent region 608 where the current increases as the motor operates at a relatively constant speed and compresses the tissue gripped by the jaw assembly.

[0129] Figure 49 shows a plot 603 of an exemplary current profile of the gripping area of ​​a stapler where the trigger is repeatedly pressed (for example, representing the jaw assembly being activated by the application of the trigger multiple times during a gripping operation). This plot includes multiple current spikes 610 as the trigger is repeatedly pulled and the motor accelerates, and a corresponding subsequent region 612 where the current is relatively constant with respect to each spike 610 as the motor then operates at a relatively constant speed to compress the tissue gripped by the jaw assembly.

[0130] Figure 50 shows a plot of exemplary current profiles in the stapler's gripping area 605 when no reload cartridge is present and 607 when a partially fired reload cartridge is present. This plot includes an initial current spike 614 when the trigger is first pulled and the motor accelerates, a subsequent region 616 where the current is relatively constant as the motor operates at a relatively constant speed to compress the tissue gripped by the jaw assembly, a region 618 where the current increases when a reload lockout failure occurs, and a region 620 where the current increases in another plot when a partial firing of the reload lockout occurs. Note that this increasing region has a slope that falls within a different range than the slope of the initial spike, and therefore the lockout module of the control system can monitor the motor current to detect the presence of a motor current exhibiting this different range of slope.

[0131] Figure 51 shows a plot 609 of an exemplary current profile of a stapler gripping instrument region with a relatively high load due to the presence of a partially fired reload (for example, indicating that the jaw assembly is gripping a relatively thick tissue specimen and the reload cartridge mounted within the jaw assembly is partially fired or used). Plot 609 includes an initial current spike 622 as the trigger is pulled and the motor accelerates, and a subsequent region 624 in which the current gradually increases as the tissue is gripped and compressed by the jaw assembly. Finally, this plot includes a rising region 626 when a partially fired reload lockout occurs. Note that the slope of the rising region 626 is different from both the initial spike 622 and the gradually rising region 624.

[0132] Figure 52 shows a plot 611 of an exemplary current profile of the gripping instrument region of a stapler where the trigger is repeatedly pressed, the load is relatively high, and a partially fired reload is present (for example, the jaw assembly is operated by the application of the trigger multiple times during a gripping operation, the jaw assembly is gripping a relatively thick tissue specimen, and a partially fired or used reload is present in the jaw assembly). Plot 611 includes multiple current spikes 628 as the trigger is repeatedly pulled and the motor accelerates, and a corresponding subsequent region 630 in which the current gradually increases after the spikes 628 as the motor operates and compresses the tissue gripped by the jaw assembly. Finally, this plot includes a rising region 632 when a partially fired reload lockout occurs. Again, the slope of the rising region 632 is different from that of the initial spike 628 and the gradually increasing current region 630.

[0133] The load and detected position may vary depending on the specifications of the motor, battery, and gearing, as well as the size and configuration of the elongated shaft, jaw assembly, and lockout mechanism. Therefore, the plots in Figures 47 to 52 only show the performance of several embodiments of the electric stapler. Despite the different lockout positions and nominal current draws, the slope of the current profile when the lockout condition occurs appears to be consistent across all tests.

[0134] The reliability of the time and position of lockout states that the control system can monitor may be low, and their rate of change is inconsistent across different loads that may occur in the gripping zone of actuator movement. Current draw conditions that occur during normal gripping device use can erroneously induce the current threshold on their own, and the voltage also changes with battery depletion. However, one consistent lockout state is the slope of the current profile relative to the actuator position, as shown in Figure 50, which falls within different tolerances when a lockout state is present. Nominal current draw shows a low slope, while gripping device use has a much steeper slope. Except in rare cases, lockout engagement has a unique current-versus-time plot that lies between other instances. The lockout slope tolerance for an elongated shaft of a particular configuration can be calculated by examining the lockout slope from a large sample size. In some embodiments, the control system may include a lockout module that monitors the slope of current draw relative to the operating shaft position and detects whether the current profile slope falls within the lockout tolerance indicating that the lockout mechanism has engaged. The lockout module of the control system can be configured to release the motor when the lockout mechanism is engaged, and to take further measures as described with respect to the motor drive profiles in Figures 50-52.

[0135] In some embodiments, the lockout module of the control system can be further improved to provide more consistent lockout engagement detection, even in the case of transient inconsistencies in monitoring the motor pull-in versus position, which should show a slope corresponding to the engagement of the lockout mechanism. In some cases, the current profile may be prone to instantaneous inconsistencies due to changes in tissue density, wear of drivetrain components, or delays in data acquisition. The current may temporarily deviate from the expected slope if one of the gears is scratched or burred, or if an unusually thick pocket of tissue is compressed. To counteract these fluctuations, in some embodiments of the lockout module in the control system, the changes in current (slope) can be averaged across multiple data entries to show a stable and reliable trend. In some embodiments, the slope of the current profile can be averaged across five data entries. While this averaging may slightly delay the detection of lockout engagement, the benefit to the false detection rate can outweigh the slight additional force that the component can withstand during this delay period.

[0136] As mentioned above, it is rare but possible for the slope to coincidentally fall within the acceptance window. One such instance is due to transient load conditions related to trigger activation. After the trigger is activated, the current profile shows a corresponding current spike. At the peak of this spike, the current settles for a moment before returning to the nominal value. During these few counts of settling, the current change may occasionally fall within the lockout tolerance range.

[0137] In embodiments of a lockout module that detects lockout engagement based solely on current gradient or profile, these data points may incorrectly indicate lockout mechanism engagement. Therefore, in some embodiments, the lockout module can be configured to detect lockout mechanism engagement only when the lowest of several consecutive averages of current gradients falls within a predetermined tolerance range. For example, the lockout module can be configured to detect lockout mechanism engagement only when three consecutive averages of current gradients fall within a tolerance range. If the average (of previous multiple current gradient profiles) falls within the lockout tolerance range, the control system stores this average, and the lockout module, at the next data acquisition by the control system (after 10 ms in some embodiments), uses the new data points to recalculate the average of the previous multiple current profiles (without including the oldest current profile value from the initial multiple current profiles), and compares this new average to the lockout tolerance range. If three consecutive values ​​fall within the lockout tolerance range, the lockout module can indicate that the lockout mechanism has engaged. If the second or third average falls outside the acceptable window, the control system can clear any stored averages and continue monitoring three consecutive current profile averages within a predetermined lockout range.

[0138] In some embodiments, the lockout module can be further improved to eliminate transient conditions that may result in incorrect lockout engagement instructions. Some motor load profiles in the gripping region have current spikes that can generate a series of consecutive current profile averages within a predetermined tolerance range, corresponding to the slope of the current profile empirically determined to be within the lockout engagement region. In some embodiments, the tolerance range can be 22.1 to 200, calculated from a current profile with current draw measured in mA units and the actuator position measured in count units in a potentiometer-based position sensing mechanism. In other embodiments, the tolerance range can be 21.1 to 200, calculated from a current profile with current draw measured in mA units and the actuator position measured in count units in a potentiometer-based position sensing mechanism. In other embodiments, the tolerance range may have different ranges based on different calculation units or different handle assemblies, shaft assemblies, or lockout mechanism configurations. As a basic principle, the control system can monitor specific qualification criteria to trigger the operation of the lockout module. For example, in some embodiments, the control system can periodically collect motor current samples and associated actuarial shaft rack position data until enough samples are available for the calculation of the average calculated by the lockout module. In some embodiments, the control system can be configured to collect samples every 10 ms, and it may be necessary to take six consecutive samples to perform the averaging calculation of the lockout module. Once enough samples have been collected, the control system can query whether the actuarial shaft is in a position that indicates that lockout may exist. In some embodiments, the control system can query the position of the actuarial shaft. In other embodiments, the control system can verify that the handle assembly is in a gripping state. In some embodiments, further qualification checks are performed to verify that the current is increasing when the actuarial shaft is moving forward.The control system can further query whether the motor current of the last collected sample is greater than or equal to that of the previous two samples, and whether the actuation shaft rack position of the last sample is greater than or equal to that of the previous samples. If all of these qualification conditions are met, the lockout module begins to evaluate whether the collected sample indicates lockout activation.

[0139] In light of the descriptions of several embodiments for detecting lockout mechanism engagement in the gripping region described above, in some embodiments, the control system may include a lockout module configured to consistently distinguish lockout mechanism engagement from other transient load conditions on the motor in the gripping region. In some embodiments, the control system may periodically monitor motor current, actuator position and elapsed time, and the lockout module may include a set of computer processor executable instructions embodied in software or firmware for calculating whether the current gradient profile indicates lockout mechanism engagement. In one embodiment, the lockout module may be configured to indicate that lockout has been engaged based generally on the following criteria: • If the system is within the lockout area • If the motor current of the test sample is greater than or equal to that of the previous two samples. • If the position of the operating shaft is greater than or equal to that of the previous sample. ·yn = motor current Δyn = slope = change in current = (yn - yn - 1) ·xn = Average of the previous 5 Δy = [(Δyn + Δyn-1 + Δyn-2 + Δyn-3 + Δyn-4) / 5] • 21.1~200 = Acceptable range = 21.1 ≤ Xn < 200 Three consecutive values ​​are required = 21.1 ≤ Xn, Xn-1, Xn-2 < 200

[0140] If it is determined that three consecutive averaged samples fall within the acceptable range, the lockout module can further assess whether lockout is present by using a bifurcated assessment, which has different calculations depending on whether the motor is operating at maximum pwm (indicating that the trigger is fully pressed) or at a pwm lower than maximum pwm.

[0141] If the trigger is pressed or released while gripping is engaged, the motor must transition from stationary to full speed. If the motor is commanded to rotate at full speed instantaneously, the resulting current spike will be large due to the sudden increase in speed. Alternatively, the current spike can be minimized by controlling the motor speed through a ramp-up cycle. This control utilizes pulse width modulation (PWM), which determines the percentage of power the motor receives. When PWM = 100, the motor operates at full speed. When PWM = 50, the motor operates at 50% of its maximum speed. By ramping up the PWM at a set interval after the trigger is moved, the motor transitions to full speed even more slowly, and any resulting current spikes are significantly reduced, although they still exist. In some embodiments, the ramp-up profile of the PWM ramp-up in the gripping region takes less than 100 ms to complete, so the motor operates at maximum PWM for most of the lockout region (which can be transitioned in about 1.5 seconds in some embodiments).

[0142] The lockout module, upon identifying three consecutive average values ​​within an acceptable range, can branch to apply different evaluation criteria depending on whether the motor is operating at maximum pWM to account for several less likely but possible use scenarios. For example, suppose a user pulls the trigger just enough to move the actuator within a small position count of the lockout mechanism, and then stops it. When the trigger is re-engaged, the user ramps up the shaft to pWM, and the jaw assembly simultaneously physically engages the lockout mechanism. Relying on the aforementioned lockout module during this unstable region would result in a delayed detection of the lockout mechanism. Instead, in some embodiments, the lockout module may further include a first criterion for identifying the presence of lockout when the motor is operating at maximum pWM and a second criterion for identifying the presence of lockout when the motor is not operating at maximum pWM, in order to more quickly detect the engagement of the lockout mechanism in the above use scenario.

[0143] The lockout module determines whether the pwm is at its maximum after it has shown that three consecutive average values ​​are within the acceptable range, which can be identified by the monitored current across the position index count. If so, the lockout module applies the first lockout evaluation criterion. If it is determined that the pwm is not at its maximum, the lockout module applies the second lockout evaluation criterion. This branch control scheme can evaluate the motor current against the baseline using a correction factor based on the expected load of the motor in operation. If the pwm is at its maximum, the gripping device function is not being utilized, and therefore the motor current is expected to be low. If the pwm is not at its maximum, the handle motor is ramping up, and therefore the motor current is expected to be high.

[0144] The evaluation criteria for the final state all rely on baseline current measurements that take into account the system's nominal current. Since the control system's lockout modules should ideally conform to the arrangement of handles, shafts, reloads, and tissue density, the system can define a baseline current for each application of the lockout module and evaluate whether the current deviates significantly from the nominal value. This baseline current measurement is performed at the first point when the system operates at maximum speed or maximum pWM. Because this measurement is performed before tissue compression, the current stabilizes at a reliable value unaffected by the load at maximum speed.

[0145] For each evaluation criterion, a position-dependent current correction value is added to this current baseline to establish a current threshold. This current correction value takes into account the positional increase in nominal current resulting from clamping and tissue compression performed within the gripping area. The position-dependent current correction value can be empirically determined for a given elongated shaft and lockout mechanism assembly by plotting the maximum nominal current value at the ideal lockout position and calculating the linear equation connecting them. These predetermined current correction values ​​can then be stored so that the lockout module can use them when evaluating the presence of lockout mechanism engagement.

[0146] In the operation of the lockout module, current thresholds are calculated for both the maximum PWM evaluation criterion and the ramp-up evaluation criterion. The monitored current is compared to the corresponding calculated current threshold, depending on whether the motor is considered to be operating at maximum PWM or ramped up. If the monitored current exceeds the corresponding calculated current threshold, the lockout module indicates that the lockout mechanism is engaged. In some embodiments, the branch evaluation criterion is embodied in a software or firmware program that operates according to the following logical structure. ·yb = current baseline = y in the first instance of maximum pwm ·yths_m=maximum speed threshold=yb+[(5 * [position)-200] ·yths_r=ramp-up threshold=yb+[(5 * position)+50] • The current must exceed the current threshold = yn>yths_m: or yn>yths_r • If the above is true, then it is locked out.

[0147] Figure 53 shows an exemplary flowchart of the lockout module. In the illustrated embodiment, when the control system refreshes the current and position monitoring (every 10 ms in some embodiments), the handle collects samples until enough are collected to perform averaging of the lockout module. The control system then evaluates various initial conditions 652, including determining whether the actuator is in the lockout region and whether both the motor current and operating position are increasing. If the initial conditions are met, the lockout module 654 is started. After verifying that the average of three consecutive current changes falls within a predetermined tolerance window, the lockout module applies a branch evaluation criterion 656 depending on whether the motor is operating at maximum pWM or below maximum pWM.

[0148] A further element of the lockout algorithm is communication with a light ring on the handle. The light ring is illuminated by an LED assembly and provides 360° light to communicate the status of the handle to the user (Figure 42). The light ring can be configured to change color based on changes in the handle assembly to a specific state. The lockout module can trigger a state specific to the control system when a lockout condition is detected, which is communicated to the user by being relayed to the light ring via the light control scheme.

[0149] While this application discloses several preferred embodiments and examples, those skilled in the art will understand that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, obvious modifications and equivalents. Furthermore, various features of these inventions can be used individually or in combination with other features of these inventions not explicitly described above. Accordingly, the scope of the present invention as disclosed herein should not be limited by the specific disclosed embodiments described above, but should be determined solely by a fair reading of the following claims. [Explanation of symbols]

[0150] 10 Surgical staplers 20 Long, slender shafts 22 Proximal end 24 Distal end 30 Jaw Assembly 32 Joe the First 34 The Second Joe 36 staples 40 Handle Assembly 42 Fixed handle 44 Trigger 46 Couplers 50 Reload L: Center longitudinal axis

Claims

1. A surgical stapling system, A handle body comprising a fixed handle and a trigger pivotably coupled to the handle body, An electric motor located inside the handle body, An operating shaft that is slidable along the longitudinal axis within the handle body, A coupler configured to be removably coupled to the reload shaft assembly, A shaft recognition mechanism, The coupler includes a lockout sleeve having a proximal end and a distal end, the lockout sleeve including at least one tooth protruding distally from the distal end, the lockout sleeve being movable to a first position proximal in the longitudinal direction when the reload shaft of the reload shaft assembly is inserted into the coupler, and being movable to a second position distal in the longitudinal direction from the first position when the reload shaft is coupled to the coupler. The lockout sleeve includes at least one lockout arm coupled to the proximal end, the lockout arm extending longitudinally within the handle body, and the lockout arm being longitudinally movable together with the lockout sleeve. Shaft recognition mechanism, A surgical stapling system characterized by having the following features.

2. The shaft recognition mechanism further includes a shaft recognition sensor disposed within the handle body and engaging with the lockout arm. The surgical stapling system according to claim 1.

3. The lockout arm includes a rack positioned on the lockout arm, and the shaft recognition sensor includes a pinion that engages with the rack of the lockout arm. The surgical stapling system according to claim 2.

4. The lockout arm includes a bent segment for positioning the rack by engaging it with the pinion. The surgical stapling system according to claim 3.

5. The coupler includes a bayonet connection, the lockout sleeve is displaced proximal to the first position when the reload shaft is inserted, and the lockout sleeve is displaced distally from the first position to the second position when the reload shaft rotates to the coupling position. The surgical stapling system according to claim 4.

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