Electric Handle Surgical Stapler

Abstract

To provide a powered handle for a reliable surgical stapling system for clamped tissue without any complex mechanism.SOLUTION: A powered handle for a surgical stapler has a drive system including an electric motor. The powered handle includes a manual articulation mechanism to articulate a jaw assembly coupled to a reload shaft connected to the handle. The manual articulation mechanism includes a ball screw mechanism that translates an articulation member in response to rotation of an articulation knob. The articulation mechanism includes a release function that allows the jaw assembly to return to a longitudinally centered orientation state. The powered handle includes a battery pack serving as the power supply for the drive system. A control system should control actuation of the motor on the basis of user input and operating parameters of the stapler. The powered handle includes a manual return mechanism.SELECTED DRAWING: Figure 14

Description

TECHNICAL FIELD

[0001] The present application relates generally to surgical occlusion instruments, and more particularly to powered surgical staplers.

[0002] DESCRIPTION OF RELATED APPLICATIONS This application is a priority claiming application of the currently pending U.S. Provisional Patent Application No. 62 / 321,629, filed on April 12, 2016, entitled "SURGICAL STAPLER HAVING A POWERED HANDLE".

BACKGROUND ART

[0003] Surgical staplers are used to approximate or clamp tissue and staple the clamped tissue to each other. Accordingly, surgical staplers have mechanisms that ensure the tissue is properly positioned and captured, and that drive staples into the tissue. As a result, this gives rise to numerous triggers and handles in association with, for example, complex mechanisms to enable proper stapling of the clamped tissue. These complex mechanisms may increase the manufacturing burden for surgical staplers, as well as create potential sources of device failure and confusion for the user. Thus, there is a demand for reliable stapling of clamped tissue without complex mechanisms.

SUMMARY OF THE INVENTION

[0004] In certain embodiments, a powered handle for a surgical stapling system is provided herein. The powered handle may have a drive system that is powered by a power source to selectively actuate an actuation adapter. The powered handle may have a manual articulation mechanism for selectively actuating an articulation adapter. The powered handle may further have a coupler with a bayonet coupling for simultaneously coupling the articulation adapter and the actuation adapter to an articulation member and a drive member disposed in a replaceable shaft.

[0005] In a particular embodiment, the motorized handle of a surgical stapling system has a control system for operating the drive system in response to user input from a movable trigger and a fire / return button provided on the motorized handle. The control system can further change the operating profile of the drive system in response to various operating parameters, including the drive system operating torque, the longitudinal position of the operating adapter, and the length or configuration of the jaw assembly.

[0006] In a particular embodiment, the electric handle of a surgical stapling system includes a manual articulation system having a ball screw mechanism. The ball screw mechanism can enable continuous articulation of the jaw assembly of the stapling system within a predetermined range of articulation. The ball screw mechanism can be biased to a longitudinal centering position and can be quickly centered using a release mechanism.

[0007] In a particular embodiment, a handle assembly for a surgical stapler is provided. The handle assembly includes a handle body, an electric motor, an operating shaft, and a mechanical return mechanism. The handle body has a stationary handle and a trigger rotatably coupled to the handle body. The electric motor is housed within the handle body. The operating shaft is slidable along its longitudinal axis within the handle body and rotatable about its longitudinal axis within the handle body. A rack is formed on the operating shaft. The operating shaft is rotatable from a first position in which the rack operatively engages with the electric motor to allow the operating shaft to slide longitudinally, to a second position in which the rack is disengaged from the electric motor and engages with the manual return mechanism.

[0008] In a particular embodiment, a handle assembly for a surgical stapler is provided. The handle assembly includes a handle body, an electric motor, an operating shaft, a motor gear, an auxiliary gear, a crown gear, a potentiometer, and a control system. The handle body has a stationary handle and a trigger rotatably coupled to the handle body. The electric motor is housed within the handle body. The electric motor has an output shaft. The operating shaft is slidable along its longitudinal axis within the handle body. The motor gear is coupled to the motor's output shaft. The auxiliary gear is driven into mesh with the motor gear. The motor gear is operatively engaged with a rack. The crown gear is housed within the handle in a meshing engagement relationship with the motor gear. The potentiometer is coupled to the crown gear. The control system is electrically coupled to the trigger, the electric motor, and the potentiometer.

[0009] In a particular embodiment, a handle assembly for a surgical stapler is provided. The handle assembly includes a handle body, a power system, an operating shaft, and an articulation mechanism. The handle body has a stationary handle and a trigger rotatably coupled to the handle body. The power system is located within the handle body. The operating shaft is operatively coupled to the power system. The operating shaft is slidable along its longitudinal axis within the handle body. The articulation mechanism includes a manual articulation knob and an articulation adapter. The manual articulation knob is positioned at the proximal end of the handle body and is rotatable around its longitudinal axis. The articulation adapter is positioned at the distal end of the handle body. The articulation adapter is operatively coupled to the articulation knob such that rotation of the operating knob around its longitudinal axis causes the articulation adapter to slide longitudinally. [Brief explanation of the drawing]

[0010] [Figure 1] This is a perspective view of one embodiment of a surgical stapling system, including an embodiment of an electric handle. [Figure 2]Figure 1 is a side view of another embodiment of the motorized handle for the surgical stapling system. [Figure 2A] Figure 2 is a disassembled and assembled perspective view of the electric handle for a surgical stapling system. [Figure 3] Figure 2 is a partially cutaway perspective view of the electric handle in which some components have been omitted to illustrate the drive system of the electric handle in Figure 2. [Figure 4] Figure 2 is a perspective view of one embodiment of a drive system for an electric steering wheel. [Figure 5] Figure 2 is a side view of one embodiment of a drive system for an electric steering wheel. [Figure 6] Figure 2 is a perspective view of one embodiment of a power supply for an electric steering wheel. [Figure 7] Figure 2 is a side view of the electric handle with the power supply in its designated mounting position. [Figure 8] Figure 2 is a perspective view of one embodiment of a positioning system for an electric steering wheel. [Figure 9A] Figure 2 is a perspective view of one embodiment of a shaft coupler for an electric handle, with one embodiment of the shaft in the detached position. [Figure 9B] Figure 2 is a perspective view of one embodiment of a shaft coupler for an electric handle, with one embodiment of the shaft in a partially inserted position. [Figure 9C] Figure 2 is a perspective view of one embodiment of a shaft coupler for an electric handle, with the shaft in the fully inserted position. [Figure 9D] Figure 2 is a perspective view of one embodiment of a shaft coupler for an electric handle, with one embodiment of the shaft in a holding position. [Figure 10A] This is a cutaway side view of one embodiment of the shaft coupler shown in Figure 2, with the shaft in a holding position. [Figure 10B]FIG. 2 is a cutaway side view of one embodiment of the shaft coupler of FIG. 2 with one embodiment of the shaft in a latched position. [Figure 11] FIG. 3 is a cutaway side view of one embodiment of the articulation mechanism of the power handle of FIG. 2. [Figure 12] FIG. 12 is a perspective view of the articulation mechanism of FIG. 11 in a position after articulation. [Figure 13A] FIG. 11 is a cutaway side view of the articulation mechanism of FIG. 11. [Figure 13B] FIG. 12 is a cutaway side view of the articulation mechanism of FIG. 11 with the release button pressed. [Figure 13C] FIG. 13 is a cutaway side view of the articulation mechanism of FIG. 11 with the release button pressed and partially returned to the centered position. [Figure 13D] FIG. 13 is a cutaway side view of the articulation mechanism of FIG. 11 with the release button pressed and returned to the centered position. [Figure 13E] FIG. 13 is a cutaway side view of the articulation mechanism of FIG. 11 in the centered position with the release button partially released. [Figure 13F] FIG. 13 is a cutaway side view of the articulation mechanism of FIG. 11 in the centered position. [Figure 14] FIG. 13 is a perspective view of one embodiment of a manual return assembly for the power handle of FIG. 2. [Figure 15] FIG. 15 is a perspective view of the manual return assembly of FIG. 14 with the uncoupling mechanism actuated. [Figure 16A] FIG. 15 is a side view of the manual return assembly of FIG. 14 with the return mechanism partially actuated. [Figure 16B] FIG. 15 is a side view of the manual return assembly of FIG. 14 with the return mechanism actuated over the full return stroke. [Figure 17] FIG. 18 is a perspective view of one embodiment of a manual return assembly for the power handle of FIG. 2. [Figure 18] FIG. 18 is a perspective view of the manual return assembly of FIG. 17 with the uncoupling mechanism actuated. [Figure 19A]Figure 17 is a side view of the manual return assembly in a partially activated state. [Figure 19B] Figure 17 is a side view of the manual return assembly in the state where the return mechanism is operated over the entire return stroke. [Figure 20] Figure 2 shows information and a schematic diagram of the power flow for one embodiment of the control system for the electric steering wheel. [Figure 21] Figure 2 is an operational sequence flowchart illustrating the operational sequence of an example electric handle. [Modes for carrying out the invention]

[0011] Referring to Figures 1 and 2, one embodiment of a surgical stapling system is shown. The illustrated embodiment of the surgical stapler 10 has 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 one embodiment of the electric handle is an electric staple firing system and an electric jaw assembly joint movement system. Figure 2 shows another embodiment of the electric handle 40 of the surgical stapler system with the elongated shaft removed. The electric handle 40 in Figure 2 is an electric staple firing system and a manual jaw assembly joint movement system. In the illustrated embodiment, the shaft 20 and the jaw assembly 30 are freely rotatable around the longitudinal axis defined by the shaft 20 by the rotation of a rotary knob provided on the handle 40. In other embodiments, the stapling system may be configured to allow rotation of the jaw assembly around the longitudinal axis within a specified range or in a rotationally fixed jaw assembly.

[0012] Continuing to refer to Figure 1, the surgical stapler 10 as an illustrated embodiment is preferably sized and shaped for use in laparoscopic surgical procedures. For example, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be introduced into the surgical field through an access port or trocar cannula. In some embodiments, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be inserted through a trocar cannula with a relatively small working channel diameter, e.g., less than 8 mm. In other embodiments, the elongated shaft 20 and jaw assembly 30 are preferably sized and shaped to be inserted through a trocar cannula with a large working channel diameter, e.g., 10 mm, 11 mm, 12 mm, or 15 mm. In other embodiments, it is envisioned that certain aspects of the surgical stapler described herein can be incorporated into a surgical stapling device usable in open surgical procedures.

[0013] Continuing to refer to Figure 1, as shown in the figure, the elongated shaft 20 has a tubular member as a whole. The elongated shaft 20 extends from the proximal end to the distal end. The elongated shaft 20 defines the longitudinal central axis L of the surgical stapler 10, which extends between the proximal end 22 and the distal end 24.

[0014] Continuing to refer to Figure 1, in the illustrated embodiment, the 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 rotatably 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 longitudinal central axis L, and this first jaw is articulate relative to the elongated shaft 20 in response to an articulation mechanism in the handle 40. In an early embodiment, a plurality of staples 36 are arranged within the first jaw 32, housed within a replaceable section 50. In other embodiments, the replaceable section 50 is preferably integrated with the jaw assembly 30 so that the entire shaft assembly 20 and the jaw assembly 30 loaded with staples constitute a single replaceable assembly. In some embodiments, the staples are preferably initially positioned within the second jaw 34.

[0015] 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, i.e., a stapled configuration, by a drive member or beam that is slidable longitudinally within an elongated shaft. In the initial position, the beam is preferably positioned at the distal end 24 of the elongated shaft 20. With the beam in the initial position, the second jaw 34 is rotated away from the first jaw 32 so that the jaw assembly 30 is in the open configuration. The actuation beam engages with the second jaw 34 when the actuation member or beam is translated distally along the longitudinal axis L. By translating the actuation beam distally from the initial position over a first distance, the jaw assembly can be operated from the open configuration to the closed configuration. With the jaw assembly 30 in the closed configuration, by returning the actuation beam proximally over a first distance, the jaw assembly 30 can be returned to the open configuration. The distal end of the working beam can advance a staple slider configured to deploy staples from the first jaw 32, and as a result, when the working beam is translated further distally beyond the first distance, multiple staples 36 are deployed from the replacement section 50 in the first jaw 32.

[0016] Continuing to refer to Figure 1, in the illustrated embodiment, the handle assembly is coupled to the elongated shaft 20 at its proximal end. As shown, the handle assembly 40 has a pistol grip configuration with a housing comprising a stationary handle 42 and a movable handle 44 or trigger rotatably coupled to the stationary handle 42. In other embodiments, it is conceivable that a surgical stapler instrument, including the aspects described herein, may have a handle assembly 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 an electrically operated mechanism configured to selectively advance the operating shaft in response to the movement of the movable handle 44.

[0017] In the illustrated embodiment, the surgical stapler 10 preferably has a plurality of staples 36 positioned within a disposable cartridge replacement section 50, while the jaw assembly 30 is configured to be reused in a single procedure along with the multiple staple cartridge replacement sections 50. In some embodiments, the elongated shaft 20 and the jaw assembly 30 constitute a disposable replaceable 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 configured to engage with the elongated shaft 20 of the surgical stapler 10. The coupler 46 preferably has a plug-in connector with an outer connector that can detachably couple the elongated shaft 20 to the handle assembly 42 and an inner connector that can detachably couple the working shaft of the handle assembly 40 to the drive member of the elongated shaft 20. Thus, the surgical stapler 10 preferably has a handle assembly 40 that can be reused along with the multiple replaceable shafts 20 during surgical procedures. In other embodiments, it is preferable that a portion of the handle assembly and elongated shaft be reusable, with the remainder of the elongated shaft within the jaw assembly forming a disposable cartridge. In certain other embodiments, the handle assembly and elongated shaft are reusable, with the jaw assembly forming a disposable cartridge. In yet another embodiment, a jaw insert containing multiple staples can form a disposable cartridge, while the remainder of the surgical stapler is reusable.

[0018] Referring to Figure 2, one embodiment of an electric handle for a surgical stapling system is shown. The electric handle can be used with various interchangeable shafts and cartridges, thereby allowing selection of shaft configurations, jaw assembly configurations, and staple configurations for specific procedures. The illustrated embodiment of the handle provides electric (motor-driven) clamping and releasing of the jaws and firing of the staple line. The joint movement of the jaw assembly can be manually controlled by an articulation knob turned by the operator. The motor is controlled by an embedded control system that defines the function of the handle during different stages of use.

[0019] Continuing to refer to Figure 2, the electric handle 40 has a pistol grip configuration with a stationary handle 42 and a movable handle 44 or trigger rotatably coupled to the stationary handle. A power supply 130 or battery is preferably located on the underside of the stationary handle. The electric handle 40 may further have a user control unit, such as a fire or fire / reverse button 150, to allow the user to selectively control the stapling sequence. The electric handle 40 may further have a redundant manual return system 170 to allow the user to manually return the stapling system to an open configuration in the event of a failure of the electric system, a failure of the control system, a power supply failure, or a "lock jaw" or other mechanical binding. The electric handle may further have 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 is rotatable as a whole around an axis that coincides with the longitudinal axis of the stapling system.

[0020] Referring to Figure 2A, the electric handle of Figure 2 is shown in an exploded assembly view. Various elements of the illustrated embodiment of the electric handle, which will be further described herein, are shown in the exploded assembly view.

[0021] Referring to Figure 3, a partial cutaway view of the electric handle is shown with the shaft 20 positioned within the handle coupler 46. In the illustrated cutaway view, several components of the electric handle are omitted to clearly show the drive system of the electric handle. In the illustrated embodiment, the drive system includes a motor 112 positioned within the stationary handle 42, a motor gear 114 mounted on the output shaft of the motor 112, and an auxiliary gear 116 that is driven-meshed with the motor gear 114. In some embodiments, the motor 112 is a brushed DC gear motor. Advantageously, the motor 112 can be laterally centered within the stationary handle by transmitting power through the auxiliary gear 116, thereby improving the balance of the handle and the user ergonomics. Furthermore, in some embodiments, the motor gear 114 and the auxiliary gear 116 are preferably configured to provide a desired operating torque at the rack 122. In some embodiments, the motor 112 preferably has a multi-gear transmission operatively coupled between the motor gear 114, which is coupled to the motor 112 and the auxiliary gear 116, to provide a desired operating torque. The motor 112 is preferably electrically coupled to the power supply 130 via a control system. The control system in the handle interfaces with the drive system to measure the position of the actuation shaft 120 and thus the operating state of the jaw assembly.

[0022] The drive system is mounted on hardware that provides information to a control system, which includes a microprocessor in the handle. This embedded system can control the motor's speed and torque. The system can also control the device's functions based on user input (moving the trigger and pressing the fire / reverse button) and the drive system's position. 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 lockout for the replaceable cartridge has been activated. The control system can also measure battery life and further limit the number of shots the device can fire.

[0023] Referring to Figure 20, a schematic flowchart showing data and power flow for an exemplary control system for an electric steering wheel is provided. In the illustrated flowchart, the control system includes the illustrated microcontroller. In various embodiments, the microcontroller may have an application-specific integrated circuit or a general-purpose microprocessor running application-specific firmware and / or software. As shown, the microcontroller receives power and battery status data from the battery in the power supply. The microcontroller further receives data from various mechanical hardware of the stapler, such as the motor drive unit and current monitor, the actuation rack position detection mechanism, and the shaft coupling and type monitor. The microcontroller further receives data from the user via a trigger position sensor, a push-button switch, and a Bluetooth® communication transceiver. The control system can output control signals to actuate the drive system of the electric steering wheel via the motor drive unit. The control system can also output certain operating parameter information to a memory module provided in the power supply, and certain data for the user to observe via LED lights provided on the steering wheel and the Bluetooth® communication transceiver.

[0024] In certain embodiments, the control system is also configured to further define the operating parameters of the electric handle. For example, by querying a memory module provided in the power supply or the control system itself, the control system can detect whether the electric handle has been used for more than one procedure. In some embodiments, the stapling system is designed for use in a single procedure and is not designed for re-sterilization. In addition, the control system can also query the power supply or a memory module provided in the control system to detect the number of staple firings and thereby evaluate whether there is enough battery power remaining to complete additional firings.

[0025] In certain embodiments, the control system is configured to detect tissue characteristics that can prevent staple firing. In some embodiments, the control system can monitor the position, speed, and torque supplied by the motor in 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 too slowly. These conditions may indicate that the tissue within the jaw assembly is too thick or too dense for the stapler to function effectively. In certain embodiments, the control system can monitor the position of the working shaft over time, and evaluate the monitored position and time against a baseline "zero-load" time reference position to assess tissue characteristics, such as thickness and density. If the drive system exceeds predetermined operating parameters, the control system can signal an error condition and stop the firing operation.

[0026] In some embodiments, the control system can provide user information via a Bluetooth® connection. The electric handle preferably has a low-power Bluetooth® transceiver that can discreetly display data on a Bluetooth® connected display, such as operating parameters, battery status, remaining shots, and estimated tissue thickness.

[0027] Referring to Figure 21, a schematic diagram of the operational flowchart for an example firing sequence of a control system is shown. As illustrated, the control system integrates user input from the trigger and firing buttons, as well as hardware input from various sensors and monitors, to advance the jaw assembly from the fully open position to the fully closed position and then return it to the fully open position in accordance with the firing sequence.

[0028] Referring to Figures 3 to 5, during electric operation, the auxiliary gear 116 is engaged with a rack 122 located on an operating shaft 120 that extends longitudinally within the handle body. In the illustrated embodiment, the auxiliary gear is supported within a guide member, through which the operating shaft 120 slides. The guide member helps maintain the engaged contact between the auxiliary gear and the rack 122. The distal end of the operating shaft 120 is freely rotatably coupled to an operating adapter 124 that extends longitudinally within a coupler 46 at the distal end of the electric handle.

[0029] With the shaft 20 coupled to the coupler 46 of the electric handle 40, the actuation adapter 124 is connected to the drive member inside the shaft 20 by a plug-in connector. Thus, when the shaft 20 is attached to the handle 40, the motor 112 and rack 122 drive the drive member 22 coupled to the jaw assembly. Thus, the drive system inside the handle is of the "rack and pinion" type. In response to user input, the motor 112 drives the actuation shaft 120 longitudinally, thereby selectively operating the stapler in the closing, firing, or opening state.

[0030] Referring to Figures 6 and 7, one embodiment of a power supply 130 for the electric handle 40 is shown. The power supply 130 is preferably configured to supply a DC current to the electric handle motor and control system. In the illustrated embodiment, the stapler can operate at 12V. The illustrated power supply preferably consists of four 3V lithium-ion batteries 132 connected in series to produce 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, a battery pack can also be formed using other numbers and configurations of individual battery cells. For example, in a particular embodiment, the battery pack may consist of AA, AAA, or other standard or dedicated single-use or rechargeable chemical batteries. In the illustrated embodiment of the electric handle 40, the battery pack is located at the bottom of the stationary handle. Preferably, this positioning provides a stable surface for mounting the handle 40 on a flat surface. In other embodiments, the power supply may be located elsewhere within the handle, for example, at its proximal end (see, for example, the embodiment in Figure 1).

[0031] Continuing to refer to Figures 6 and 7, in some embodiments, the power supply 130 is preferably packaged with the handle 40 but not installed before use. When in use, the user may install the battery pack by inserting it into a battery cavity 136 located at the handle 40. Advantageously, transporting the battery pack in an uninstalled state reduces the rate of accidental battery discharge before use. Furthermore, a removable battery pack allows the stapler system to be easily upgraded with new batteries when new battery technology becomes available. In other embodiments, the power supply is preferably packaged in a state where a removable strip prevents the electrical connection of the battery pack from being made. In yet another embodiment, the handle is supplied with an AC or DC power supply, and a power cable configured to plug into, for example, a wall socket or outlet, a USB connector, or another standard electrical connection.

[0032] In some embodiments, the power supply further includes a memory module, such as non-volatile memory, capable of storing a digital record of the stapler's usage status. For example, the memory module may be configured to record details of each stapler firing, including the battery voltage and motor current during firing, a sequence of software and machine states, any unforeseen circumstances that may have occurred, the type of shaft used, the number of firings, the interval between firings, and periodic sampling of the stapler handle model and serial number. The memory module may also record whether the user is unable to reuse the battery pack using the battery pack itself.

[0033] In some embodiments, the electric handle 40 and associated power supply 130 are preferably configured to be used in a single procedure and disposable thereafter. The power supply 130 is preferably provided with a power drain to reduce the risk of reuse. Following use in a surgical procedure, the user can remove the battery pack from the handle 40. Removing the battery pack from the handle 40 initiates battery draining or depletion. For example, after the battery pack has been used once, the battery can be short-circuited by connecting its terminals to a low-value resistor or an electrical feature, and the same work can be accomplished with the same circuit. In addition, if the battery pack remains in the handle 40 after the surgical procedure is completed, in some embodiments, the handle's control system is programmed to deactivate the function after a maximum time limit to deplete the battery pack.

[0034] Referring to Figures 2 and 8, one embodiment of a position sensor mechanism used in an electric handle is shown. In terms of operation, the rotation of a motor gear 114 causes a corresponding rotation of a crown gear 142 located within the handle 40. The crown gear 142 is coupled to a potentiometer, so that the position of the motor gear 114 and thus the actual position of the actuation rack can be determined based on the measurement of the change in resistance at the potentiometer. In some embodiments, the potentiometer is preferably mounted on a circuit board 144 on which a control system can be implemented. While the illustrated embodiment includes a position sensor mechanism utilizing a potentiometer, other embodiments may use other position detection mechanisms, such as the use of a magnetic encoder with a Hall effect sensor, a limit switch that acts when the actuation shaft has moved a predetermined distance, an optical system for measuring the amount of movement of a pattern along the actuation shaft, such as the use of a photodiode, or other position detection systems.

[0035] Referring to Figures 9A to 9D, the operational sequence of engagement between the stapler shaft 20 and the handle coupler 46 is shown. In the illustrated embodiment, the connection between the replaceable shaft 20 and the handle 40 consists of a plug-in connection, in which the user inserts the replaceable shaft 20 into the handle 40 axially, and then rotates the replaceable shaft 20 by approximately 90° to connect them. This plug-in connection operatively couples the two mechanical functions of the plug-in shaft 20 to the corresponding actuators of the handle 40. When the plug-in connection is fully coupled, the articulated member within the shaft 20 is coupled to the articulated adapter of the handle, and the drive member within the shaft 20 is coupled to the actuating adapter. Furthermore, the handle 40 and shaft 20 are preferably configured with a latch mechanism provided at the coupler 46 to prevent the user from removing the shaft 20 once the actuating adapter and drive member are actuated. Furthermore, the connection point at the coupler 46 may have a replacement part identification mechanism so that the handle control system can detect whether a replacement shaft has been connected and what the jaw length of the replacement part is when installed there. It is assumed that the electric handle can be used with replacement shafts 20 that include jaw mechanisms of various lengths. For example, in some embodiments, the same handle 40 can be used with either a 45 mm or 60 mm jaw assembly. Thus, once the jaw assembly length is identified by the electric handle control system, the control system can determine a motor operating profile for the stapler firing stroke corresponding to the identified length of the jaw assembly.

[0036] In Figure 9A, the shaft 20 is positioned parallel to the coupler 46 provided on the handle, and the release knob of the coupler 46 is retracted to expose the insertion channel 152 of the coupler 46 when the coupler 46 is rotated into place. The shaft 20 may have a retaining post 22 or boss that can be positioned within the insertion channel 152. In the illustrated embodiment, the shaft has two bosses positioned 180° apart on its outer surface, and the coupler 46 has two corresponding insertion channels 152. In other embodiments, it is conceivable that other numbers and forms of bosses and insertion channels can be used to achieve the desired coupling strength and ease of alignment.

[0037] Referring to Figure 9B, the shaft retaining post 22 is positioned within the insertion channel 152. Referring to Figure 9C, the replaceable shaft 20 is rotated 90° relative to the handle, so that the shaft retaining shaft 22 reaches the connecting end of the insertion channel 152. Referring to Figure 9D, the coupler release knob is released so that the retaining recess 154 provided in the release knob can hold the retaining post 22 of the replaceable shaft 20.

[0038] Referring to Figures 10A and 10B, a cut-out side view of the coupler 46 is shown together with the replaceable shaft 20. The retaining post 22 of this shaft is positioned within the retaining recess of the insertion channel. The actuating adapter 124 is coupled to a drive member 26 that extends longitudinally within the shaft 20. Figure 10B shows a lock-in or retaining mechanism that operates during the initial distal advance of the actuating adapter 124. As shown, the locking member 24 is rotatably coupled to the proximal end of the shaft 20.

[0039] Continuing to refer to Figure 10B, the locking member 24 preferably has an inclined or tapered locking surface at its proximal edge. As illustrated in Figure 10A, the shaft 20 is coupled to the coupler 46 but in a disengaged configuration. In the coupled disengaged configuration, the shaft 20 can be removed from the coupler 46 via the plug-in connector by reversing the sequence of operations shown in Figures 9A to 9D. Once the operating adapter 124 moves forward to operate the stapler, the operating adapter 124 interacts with the inclined surface of the locking member 24, causing the locking member to move radially outward to the locked position. In the locked position (Figure 10B), the locking member 24 engages with a locking shelf-like projection provided on the coupler 46 to lock into the shaft. When the shaft 20 is locked in to the handle 40, the shaft 20 cannot be removed from the handle 40 until the operating adapter 124 returns to a position that is fully retracted to the proximal side (typically corresponding to the full closure of the jaw assembly and its return to the jaw-open configuration following the stapling cycle).

[0040] Thus, the "lock-in" feature prevents the user from removing the shaft from the handle once the drive member 26 is driven forward. Once the locking member 24 is positioned in the slot or shelf projection of the rotating insert of the coupler 46, the release knob of the coupler 46 cannot be pulled back. This locking action on the coupler prevents the user from rotating the shaft 20 and removing it from the insertion connection of the coupler 46 once the stapler operation has begun.

[0041] Referring to Figures 11, 12, and 13A–13F, one embodiment of an articulation mechanism for an electric handle 40 is shown. In the illustrated embodiment, the handle can articulate the jaw assembly up to 45° in any direction at the distal end of the shaft, after full articulation relative to the longitudinally centered position. In some embodiments, the electric handle uses a manual articulation mechanism that includes a series of components coupled to a manual actuation knob 190 at the proximal end of the handle. In other embodiments, the manual actuation knob and certain associated elements of the articulation mechanism may be positioned at other locations on the handle, for example, adjacent to the distal end of the handle.

[0042] Referring to Figures 11 and 12, the joint movement mechanism is connected to a longitudinally extending joint movement member 206 within the replaceable shaft when the replaceable shaft is coupled to the handle. When the joint movement mechanism is operated longitudinally, the joint movement member 206 translates proximal or distal to the shaft, causing the jaw assembly to articulate at the distal end of the shaft.

[0043] Referring to Figure 11, the articulated joint 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 fitted. In the illustrated embodiment, the articulated joint mechanism includes two ball bearings 194 that can be fitted into two threads 195. The ball bearings 194 are positioned in ball bearing holes 189 provided in a ball sleeve 191 positioned radially outward from the ball screw 192. The ball bearings 194 are held in the threads 195 by a release sleeve 196 positioned radially outward from the ball bearings 194. For example, rotation of an articulated joint knob 190 coupled to the ball sleeve 191 by a connecting pin 193 causes the ball sleeve 191 to rotate around its axis of rotation, thereby moving the ball bearings 194 within the threads 195 and correspondingly translating the ball screw 192 longitudinally. The articulation of the jaw assembly is achieved by rotating the articulation knob 190, which in turn rotates the ball sleeve 191 and ball bearing 194 around the axis of rotation, with their longitudinal positions fixed along the axis of rotation. The ball bearing 194, fitted into the threads 195 of the ball screw 192, then translates the ball screw 192 back and forth along the axis of rotation. In the illustrated embodiment, the ball sleeve 191 is tubular as a whole, and a cavity is formed in this ball sleeve, in which a portion of the ball screw 192 is positioned and translated longitudinally within the cavity. The articulation mechanism in the illustrated embodiment includes two ball bearings that can engage with the threads in the ball screw, but in other embodiments, the articulation mechanism may include fewer than two or more ball bearings, for example, a single ball bearing positioned in a single helical screw or three or four or more ball bearings positioned in a corresponding number of helical threads.

[0044] 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 spaced apart from each other, thereby preferably positioning the articulation links radially outward from the drive system and actuation shaft within the handle. As shown in Figure 12, the articulation links 202 may have mating feature parts, such as slots, which can be keyed into a corresponding mating feature part, such as a post, extending radially inward from the handle body. The slots can stabilize the articulation links relative to the handle, and the interaction between the handle post and the end of the slot can define the range of articulation of the articulation mechanism. The distal end of the articulation link 202 may be rotatably coupled to an articulation adapter 204, which can be positioned radially outward coaxially with the actuation adapter at the distal end of the handle. This rotatable coupling may include an articulation bearing 205 with relatively low friction characteristics. The articulation bearing 205 facilitates the rotation of the replaceable shaft coupled to the handle assembly and the longitudinal movement of the articulation adapter 204 during the operation of the articulation mechanism. The articulation mechanism in the illustrated embodiment includes two articulation links offset laterally from the actuation mechanism in the handle, but in other embodiments, the articulation mechanism may include fewer than two or more articulation links, such as one articulation link or three or four or more articulation links.

[0045] Continuing to refer to Figure 12, once the shaft is connected to the handle, the joint movement adapter 204 can be inserted and connected to the joint movement member 206 inside the shaft by the connecting part. The screw thread 195 is preferably configured such that when the ball screw is moved in the proximal direction, the jaw assembly articulates to the left relative to the longitudinal centering position as viewed from the handle, and when the ball screw 192 is moved distally, the jaw assembly articulates to the right relative to this longitudinal centering position as viewed from the handle.

[0046] Advantageously, since the helical threads 195 of the ball screw 192 are continuous, the articulation mechanism can articulate the jaw assembly to virtually infinite angular positions between desired ranges of motion. In some embodiments, the articulation mechanism is preferably configured to provide an articulation range of motion of the jaw assembly from -45° to +45° with respect to a longitudinal centered position defined by the longitudinal axis of the shaft. In other embodiments, the articulation mechanism may be configured to provide other ranges of motion, including ranges that result in articulation greater than ±45° or ranges that result in articulation less than ±45°. In some embodiments, the articulation mechanism may be configured to provide articulation in a single direction with respect to the longitudinal centered position.

[0047] In some embodiments, the pitch of the threads 195 provided on the ball screw 192 varies. For example, the threads 195 may have a relatively small pitch toward the ends of the threads to provide a significant mechanical advantage when the jaw assembly may require a greater force to articulate. The threads 195 may have a relatively large pitch toward the center of the threads to allow for rapid movement with a relatively small mechanical advantage when the jaw assembly may require a small force to articulate. In other embodiments, the threads 195 provide a proportional amount of articulation of the stapler jaw assembly that does not change over the range of articulation of the articulation mechanism as a result of the rotation of the articulation knob. Preferably, such a constant-pitch threaded ball screw can, as a result, provide an easily predictable response during operation of the operating mechanism.

[0048] Referring to Figures 13A to 13F, the joint movement mechanism preferably includes a release mechanism that allows the joint movement mechanism to be reset from any post-joint movement position to a longitudinally centered position. The release mechanism is activated by the user pressing a release button 198. In the illustrated embodiment, the release button 198 is positioned radially fitted within the joint movement knob 190.

[0049] Referring to Figure 13B, the release sleeve 196 advances distally when the release button 198 is activated. The radial inner surface of the release sleeve 196 is stepped to have an engagement surface 186 with a relatively small inner diameter and a release surface 188 with a relatively large inner diameter, and the inclination between the engagement surface and the release surface is smooth. To explain the operating principle, the engagement surface of the release sleeve holds the ball bearing 194 within the threads 195 of the ball screw 192. Once the release button 198 is pressed, the engagement surface is advanced distally, thereby allowing the ball bearing 194 to disengage from the threads 195 and advance radially outward through the ball bearing hole 189 provided in the ball sleeve to strike the release surface.

[0050] Referring to Figures 13C and 13D, the joint mechanism is preferably biased to the centered position with the ball bearing 194 disengaged from the thread 195. In some embodiments, the ball screw 192 is biased to the centered position by a biasing member, such as two springs 197 and spring force from a shaft. The ball bearing 194, positioned to the centered position (Figure 13D) along the thread 195, corresponds to the longitudinal centered position of the jaw assembly.

[0051] Referring to Figures 13E and 13F, once the release button 198 is returned to an unobstructed position, the release sleeve 196 is retracted proximally (indicated by arrow 199) by the spring. The proximal movement of the release spring 196 causes the ball bearing 194 to engage with the threads 195 of the ball screw. Thus, the articulated mechanism can then be used to articulate the jaw assembly from its longitudinally centered position, or the stapler can be used with the jaw assembly in its longitudinally centered position.

[0052] Referring to Figures 14, 15, and 16A and 16B, one embodiment of the manual return mechanism for an electric handle is shown. The manual return mechanism can be a redundant return mechanism, which is advantageous in the event of a power failure, failure of other electric components, or mechanical failure or binding.

[0053] Referring to Figures 14 and 15, the manual return mechanism includes two separately and independently operable subassemblies that operate in sequence to return the actuarial shaft 120 to its most proximal position within the handle, which corresponds to the open configuration of the jaw assembly. As shown, the manual return mechanism 170 includes a shaft rotation mechanism and a shaft retraction mechanism. To explain the operating principle, if it is desirable to manually return the stapler to the open configuration, the shaft rotation mechanism is activated first.

[0054] Referring to Figures 14 and 15, to actuate the shaft rotation mechanism of the manual return mechanism 170, the user pulls a disengagement or release tab 172 located on the outer surface of the handle. A disengagement or release rack 174 is formed on the disengagement tab 172. The disengagement rack 174 is engaged with a shaft rotation rack 176 formed on the shaft rotation collar 176. The actuating shaft 120 passes through and is slidable through the shaft rotation collar 176. Thus, by pulling the disengagement tab 172, the rotation shaft 120 rotates approximately 90° around its longitudinal axis. This rotation positions the rack 122 of the actuating shaft so as to disengage from the auxiliary gear 116 of the drive system. Furthermore, in some embodiments, the removal of the disengagement tab 172 from the handle can also disengage the power supply from the drive system or, in a different way, the control system, thereby preventing further electric operation of the electric handle. Furthermore, the shaft rotation mechanism is preferably configured to be operated only once. For example, in the illustrated embodiment, the shaft retraction mechanism has a return claw 182 that, once it pulls the shaft rotation release tab 172, has an obstruction lobe 183 that is dimensioned and shaped to obstruct the drive system in order to prevent the return lever from closing and to prevent the rotation of the rotating shaft 120 from returning to the engaged state with the auxiliary gear. Thus, once the shaft rotation mechanism is operated, the handle can be disabled so that it cannot be used any further.

[0055] Referring to Figures 15, 16A, and 16B, once the shaft rotation mechanism is activated, the shaft retraction mechanism can be operated to return the operating shaft to its proximal position within the handle. Removing the release tab 172 from the handle exposes the return lever 180 located on the electric handle. The return lever 180 is rotatably coupled to the return pawl 182 at the pivot joint 184. When the rack 122 of the operating shaft 120 is rotated to disengage it from the drive system, this rack is rotated to engage with the shaft retraction mechanism. Rotating the return lever 180 over one or a series of return cycles (Figures 16A and 16B) allows the return pawl 182 to engage with the rack 122 of the operating shaft 120, and the operating shaft 120 can be retracted to its proximal position within the handle in a ratchet-type operation.

[0056] Referring to Figures 17, 18, and 19A and 19B, another embodiment of the manual return mechanism for an electric handle is shown. The components and operating principle of the manual return mechanism 170' are substantially the same as those described above with reference to the manual return mechanism 170 in Figures 14, 15, and 16A and 16B. However, in using the manual return mechanism 170', the disengagement tab 172' from the handle assembly exposes the shaft rotation collar 176' from which the rotating lever 178' protrudes. When the handle assembly is in an electrically operated state, the disengagement tab 172' covers the shaft rotation collar 176' which is located on the outer surface of the handle. Once the disengagement tab is removed, the user can then operate the rotating lever 178' to rotate the actuating shaft 120, thereby activating the shaft retraction mechanism and returning the actuating shaft to the proximal side within the handle. The shaft retraction mechanism of the manual return mechanism 170' has the same ratchet-type operating mechanism as described above with respect to the manual return mechanism 170. Preferably, in some handle configurations, the rotating lever 178' can provide a significant mechanical advantage in facilitating the rotation of the operating shaft compared to a shaft rotation mechanism including the disengagement rack 174 in Figures 14, 15, and 16A and 16B.

[0057] While this application discloses certain preferred embodiments and examples, as will be understood by those skilled in the art, the present invention extends beyond the specifically disclosed embodiments to other modified embodiments and / or uses of the invention, as well as obvious modifications and their equivalents. Furthermore, various features of these inventions can be used individually or in combination with other features of these inventions other than those explicitly described above. Thus, the scope of the present invention disclosed herein is not intended to be limited by the specific disclosed embodiments described above, but rather to be determined solely by a fair interpretation of the claims.

Claims

1. A handle assembly for a surgical stapler, wherein the handle assembly is A handle body, the handle body having a stationary handle and a trigger rotatably coupled to the handle body, A power system provided within the handle body, An operating shaft connected to the power system, wherein the operating shaft is slidable along its longitudinal axis within the handle body, Joint connection mechanism and The manual return mechanism includes a mechanism that can be selectively operated to disengage the power system from the operating shaft and retract the operating shaft to the proximal side. A handle assembly characterized by the following features.

2. The aforementioned joint connecting mechanism is A manually operated articulated connecting knob is positioned at the proximal end of the handle body and is rotatable around the longitudinal axis, The handle assembly according to claim 1, further comprising an articulated connector adapter positioned at the distal end of the handle body, wherein the articulated connector adapter is coupled to the manual articulated connector knob such that the articulated connector adapter slides in the longitudinal direction by the rotation of the manual articulated connector knob around the longitudinal axis.

3. The handle assembly according to claim 2, further comprising a release mechanism.

4. The handle assembly according to claim 3, wherein the release mechanism is configured to reset the joint connecting adapter to the longitudinally centered position.

5. The aforementioned joint connecting mechanism is The invention further includes a ball screw, the ball screw having a helical thread formed within it. The ball screw is positioned radially outward and further includes a ball sleeve with a hole formed in it, The handle assembly according to claim 2, further comprising a ball bearing positioned within the hole of the ball sleeve and fitted into the helical threads of the ball screw.

6. The handle assembly according to claim 5, wherein the ball screw is movable in the longitudinal direction relative to the handle body, and the ball screw moves in the longitudinal direction due to the movement of the ball bearing within the helical threads.

7. The handle assembly according to claim 5, wherein the ball screw has a distal end, and the handle assembly further includes an articulated link that is coupled to the distal end of the ball screw and extends distally within the handle body to the articulated adapter.

8. The handle assembly according to claim 5, wherein the ball sleeve is rotatably coupled to the manual articulated connecting knob.

9. The handle assembly according to claim 5, wherein the joint connecting mechanism further includes a release mechanism configured to reset the joint connecting adapter to a longitudinally centered position.

10. The handle assembly according to claim 9, wherein the release mechanism includes a release button engaged with a release sleeve, and the ball bearing is released from the helical threads by operation of the release button.

11. The handle assembly according to claim 10, wherein the release sleeve has an inner surface including an engaging surface having a first inner diameter and a release surface having a second inner diameter larger than the first inner diameter.

12. The handle assembly according to any one of claims 1 to 11, wherein the operating shaft is rotatable from a first position in which the operating shaft is connected to the power system to a second position in which the operating shaft is disengaged from the power system and engaged with the manual return mechanism.

13. The manual return mechanism is A shaft rotation mechanism configured to rotate the operating shaft from the first position to the second position, The handle assembly according to claim 12, further comprising a shaft retraction mechanism configured to retract the operating shaft to the proximal side.

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