Low cost powered stapler with selectable end stops

Abstract

The present disclosure relates to low cost powered staplers with selectable end stops and provides a surgical stapler including a loading unit having a cartridge with a cartridge distance and a plurality of staples and an anvil forming the plurality of staples upon firing. The surgical stapler further includes a shaft assembly coupled to the loading unit. The shaft assembly includes a drive shaft longitudinally movable within the shaft assembly and configured to actuate the loading unit. The surgical stapler further includes a handle assembly having a power source and a motor coupled to the power source and configured to longitudinally move the drive shaft. The handle assembly further includes a distance setting interface including a plurality of switches, each of the switches corresponding to a travel distance of the motor moving the drive shaft, the travel distance corresponding to the cartridge distance.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 065,601, filed August 14, 2020. The entire contents of the foregoing application are incorporated herein by reference. Technical Field

[0003] This disclosure relates to an electric surgical suture device. More specifically, this disclosure relates to a handheld, electric electromechanical surgical suture device configured for use with detachable, disposable or reusable loading units of varying lengths, the loading units having user-selectable distance settings. Background Technology

[0004] Electric surgical suture devices utilize one or more electric motors to actuate various mechanical end effectors having an anvil and a staple cartridge. Suture end effectors may include reusable loading units and / or disposable loading units having staples of various sizes and arranged in one or more configurations (e.g., multi-row).

[0005] The loading unit has an end stop, which is an indicator that all nails have been fired. Rapid detection of the end stop is utilized in electric surgical staplers to prevent damage to the device. During surgery, the stapler can detect the end stop in the end effector assembly by measuring various operating parameters of the motor (e.g., torque or current). However, this method relies on complex software algorithms, which are costly to develop and implement. Furthermore, if the end stop is not detected correctly, various moving parts are likely to collide upon reaching the end stop as the motor continues to run, potentially causing device damage. In addition to the potential damage, reaching the mechanical limit can also cause twitching or unnecessary clamping movements within the loading unit, negatively impacting the accuracy and efficiency of the device during firing and potentially causing increasing damage over time.

[0006] Therefore, there is a need for a low-cost electromechanical stitcher that can avoid the negative effects of reaching mechanical limits without any expensive software algorithms based on torque or motor current. Summary of the Invention

[0007] This disclosure provides a surgical electric suture device having a user-configurable end-stop distance, the surgical electric suture device being equipped with a motor that actuates the suture end effector to move a predetermined distance related to a user-selectable distance setting.

[0008] According to one embodiment of this disclosure, a surgical stapler is disclosed. The surgical stapler includes a loading unit having: a staple cartridge having a cartridge distance and a plurality of staples, and an anvil that forms the plurality of staples upon firing. The surgical stapler also includes a shaft assembly coupled to the loading unit. The shaft assembly includes a drive shaft that is longitudinally movable within the shaft assembly and configured to actuate the loading unit. The surgical stapler further includes a handle assembly having a power source and a motor coupled to the power source and configured to longitudinally move the drive shaft. The handle assembly also includes a distance setting interface including a plurality of switches, each of which corresponds to a travel distance of the drive shaft moved by the motor, the travel distance corresponding to the cartridge distance.

[0009] According to one aspect of the above embodiments, the distance setting interface includes a sliding switch configured to move within a slit defined in a housing of the handle assembly. The sliding switch is configured to engage each of a plurality of switches.

[0010] According to another aspect of the above embodiments, each of the plurality of switches includes a light source activated in response to engagement of the corresponding switch. Each of the plurality of switches is a lockable push-button switch capable of moving from an unlocked state to a locked state upon actuation. The surgical stapler also includes a controller coupled to a distance setting interface and configured to reset the locked state of the actuation switch. A first switch of the plurality of switches is configured to operate the motor in a first mode. A second switch of the plurality of switches is configured to operate the motor in a second mode. During the first mode, the motor is configured to longitudinally move the drive shaft until a mechanical limit is reached. During the second mode, the motor is configured to longitudinally move the drive shaft until a travel distance is reached.

[0011] According to another aspect of the above embodiments, a method for controlling a surgical suture device is disclosed. The method includes coupling a loading unit to a shaft assembly, the loading unit including a cartridge having a cartridge distance and a plurality of staples, and an anvil forming the plurality of staples upon firing. The method further includes activating one of a plurality of switches disposed on a handle assembly, and setting a travel distance corresponding to the cartridge distance in response to the activation of the switch. The method further includes activating a motor disposed within the handle assembly to longitudinally move a drive shaft a travel distance to actuate the loading unit.

[0012] According to one aspect of the above embodiments, setting the travel distance includes a sliding switch configured to move within a slit defined in a housing of the handle assembly. The sliding switch is configured to engage each of a plurality of switches. The method further includes activating a light source associated with an activated switch.

[0013] According to another aspect of the above embodiments, each of the plurality of switches is a lockable push-button switch that can be moved from an unlocked state to a locked state upon actuation. The method further includes resetting the locked state of the actuating switch. The method also includes activating a first switch among the plurality of switches to operate the motor in a first mode and activating a second switch among the plurality of switches to operate the motor in a second mode. The method further includes longitudinally moving the drive shaft until a mechanical limit is reached during the first mode and longitudinally moving the drive shaft until a travel distance is reached during the second mode. Attached Figure Description

[0014] The following describes various aspects of a disclosed surgical suturing device, including an active end-stop selection mechanism, with reference to the accompanying drawings, wherein:

[0015] Figure 1 This is a perspective view of an electric surgical instrument according to an embodiment of the present disclosure;

[0016] Figure 2 Based on embodiments of this disclosure and Figure 1 A perspective view of the loading unit used in conjunction with an electric surgical suture device;

[0017] Figure 3 According to embodiments of this disclosure Figure 2 Exploded perspective view of the loading unit;

[0018] Figure 4 According to embodiments of this disclosure Figure 1 A schematic diagram of surgical instruments;

[0019] Figure 5 According to another embodiment of this disclosure Figure 1 A perspective view of the handle assembly of a surgical instrument; and

[0020] Figure 6 This is according to yet another embodiment of the present disclosure. Figure 1 A perspective view of the handle assembly of a surgical instrument. Detailed Implementation

[0021] The disclosed electric surgical suture device is described in detail with reference to the accompanying drawings, in which similar reference numerals denote the same or corresponding elements in each of the several views. However, it should be understood that the aspects of this disclosure described herein are merely examples and can be implemented in various forms. To avoid unnecessarily obscuring this disclosure, well-known functions or constructions have not been described in detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as the basis for the claims and a representative basis for teaching those skilled in the art to use this disclosure differently with virtually any suitable detailed construction.

[0022] In this specification, the term "proximal" is generally used to refer to the portion of the device that is closer to the clinician during its conventional use, while the term "distal" is generally used to refer to the portion of the device that is farther from the clinician during its conventional use. Additionally, the term "endoscope" is generally used to refer to any other surgical procedure performed via endoscopy, laparoscopy, arthroscopy, and / or through a small-diameter incision or cannula. Furthermore, the term "clinician" is generally used to refer to medical personnel, including doctors, nurses, and support staff.

[0023] The system described herein can utilize one or more controllers to receive various information and transform the received information to generate output. The controller may include any type of computing device, computing circuitry, or any type of processor or processing circuit capable of executing a series of instructions stored in memory. The controller may include multiple processors and / or a multi-core central processing unit (CPU), and may include any type of processor, such as a microprocessor, digital signal processor, microcontroller, etc. The controller may also include memory for storing data and / or algorithms to execute a series of instructions.

[0024] Any of the methods, programs, algorithms, or code described herein may be contained on one or more machine-readable media or memories. The term "memory" may include mechanisms that provide information in a machine-readable form (e.g., storing and / or transmitting) such as a processor, computer, or digital processing device. For example, memory may include read-only memory (ROM), random access memory (RAM), disk storage media, optical storage media, flash memory devices, or any other volatile or non-volatile memory storage devices. The code or instructions contained thereon may be represented by carrier signals, infrared signals, digital signals, and other similar signals.

[0025] First refer to Figure 1 An electromechanical, handheld, electric surgical stapler according to aspects of this disclosure is shown and generally designated as 10. The electric surgical stapler 10 includes a handle assembly 100 configured to selectively attach via a shaft assembly 120 to a plurality of different loading units 300, each loading unit being configured to be actuated and manipulated by the handle assembly 100. The shaft assembly 120 includes a distal coupler 230 configured to connect to the loading unit 300 and house a drive shaft 240. The drive shaft 240 is longitudinally movable within the shaft assembly 120.

[0026] The handle assembly 100 can be configured to selectively connect with the shaft assembly 200, and the shaft assembly 120 is subsequently configured to selectively connect with the loading unit 300. The handle assembly 100 includes a handle housing 102 that accommodates the following... Figure 4Various components are described, such as the electric motor, drive shaft, and / or gear components configured to actuate the loading unit 300.

[0027] refer to Figure 2 and 3 The loading unit 300 includes an end effector 304 having an anvil assembly 306 and a bin assembly 308. The drive assembly 360 of the loading unit 300 includes a flexible drive shaft 364 having a distal end fixed to a drive beam 365 and a proximal end engagement portion 368, the proximal end engagement portion being configured to couple to the drive shaft 240 of the shaft assembly 120 when the loading unit 300 is attached to the distal coupler 230 of the shaft assembly 120. Figure 1 ).

[0028] As the drive assembly 360 is advanced distally within the loading unit 300, the upper beam of the drive beam 365 moves within the channel defined between the anvil plate 312 and the anvil cover 310, and the lower beam moves within the channel of the nail cartridge 305 and across the outer surface of the carrier 316 to close the end effector 304 and launch nails from it.

[0029] The proximal body portion 302 of the loading unit 300 includes a sheath or outer tube 301 surrounding the upper housing portion 301a and the lower housing portion 301b. The housing portions 301a and 301b surround a hinged link 366 having a hook-shaped proximal end 366a extending from the proximal end of the loading unit 300. When the loading unit 300 is secured to the distal housing 232 of the shaft assembly 120, the hooked proximal end 366a of the hinged link 366 engages a coupling hook (not shown) of the shaft assembly 120. When the drive rod (not shown) of the shaft assembly 120 advances or retracts as described above, the hinged link 366 of the loading unit 300 advances or retracts within the loading unit 300 to pivot the end effector 304 relative to the distal end of the proximal body portion 302.

[0030] The end effector 304's cartridge assembly 308 includes a staple cartridge 305 that can be supported in a carrier 316. The staple cartridge 305 defines a central longitudinal slot 305a, and three linear rows of staple holding slots 305b are positioned on each side of the longitudinal slot 305a. Each of the staple holding slots 305b receives a single staple 307 and a portion of a staple pusher 309. During operation of the electric surgical suture device 10, the drive assembly 360 abuts the actuation slide 350 and pushes the actuation slide 350 through the cartridge 305. As the actuation slide moves through the cartridge 305, the cam wedge of the actuation slide 350 continuously engages the staple pusher 309 to vertically move the staple pusher 309 within the staple holding slot 305b and continuously ejects the staple 307 from the staple holding slot to abut against the anvil plate 312.

[0031] refer to Figure 4The electric surgical suture device 10 includes a motor 164, which can be any electric motor configured to actuate one or more drive shafts 240. The motor 164 is coupled to a battery 156, which can be a DC battery (e.g., a rechargeable lead-acid battery, nickel-based battery, lithium-ion battery, etc.), an AC / DC transformer, or any other suitable power source for supplying power to the motor 164.

[0032] Battery 156 and motor 164 are coupled to motor drive circuitry 404 mounted on circuit board 154. Motor drive circuitry controls the operation of motor 164, including the flow of electrical energy from battery 156 to motor 164. Drive circuitry 404 may include multiple sensors 408a, 408b, ... 408n configured to measure the operating states of motor 164 and battery 156. Sensors 408a-n may include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. Sensors 408a-408n can measure the voltage, current, and other electrical properties of the electrical energy supplied by battery 156. Sensors 408a-408n can also measure the rotational speed (e.g., revolutions per minute (RPM)), torque, temperature, current draw, and other operating properties of motor 164. RPM can be determined by measuring the rotation of motor 164. The position of drive shaft 240 can also be determined by using various linear sensors mounted in or near the shaft, or by extrapolating the position from RPM measurements. In one embodiment, torque can be calculated based on the regulated current drawn by the motor 164 at a constant RPM. In other embodiments, the drive circuit 404 and / or controller 406 can measure time and process the values ​​described above that vary over time, including integration and / or differentiation, for example, to determine changes in the measured values, etc.

[0033] The drive circuit 404 is also coupled to a controller 406, which may be any suitable logic control circuit adapted to perform calculations and / or operate according to a set of instructions described in further detail below. The controller 406 may include a central processing unit operatively connected to a memory, which may include transient type memory (e.g., RAM) and / or non-transient type memory (e.g., flash media, disk media, etc.). The controller 406 includes multiple inputs and outputs for interfacing with the drive circuit 404. Specifically, the controller 406 receives sensor signals from the motor circuit 404 regarding the operating state of the motor 164 and the battery 156, and then outputs control signals to the motor circuit 404 to control the operation of the motor 164 based on sensor readings and specific algorithmic instructions (discussed in more detail below). The controller 406 is also configured to accept multiple user inputs from a user interface (e.g., buttons 202 and 204 coupled to the controller 406, distance setting interface 205, etc.).

[0034] refer to Figure 1 The electric surgical suture device 10 includes a pair of buttons 202 and 204 configured to activate a motor 164 to operate a drive shaft 240 in the longitudinal direction, distally and proximally, respectively. When button 202 is pressed, the motor 164 operates in the first direction, for example, rotating clockwise, and the drive shaft 240 moves distally, causing the drive assembly 360 of the loading unit 300 to also move distally along with the drive beam 365. This, in turn, moves the anvil assembly 306 toward the chamber assembly 308 and simultaneously ejects staples 307 to clamp, suture, and cut the tissue held between the anvil assemblies 306 as they move toward the chamber assembly 308. Pressing button 204 reverses the motor 164, and the motor 164 operates in the second direction, for example, rotating counterclockwise. The drive shaft 240 is retracted and moved proximally, causing the drive assembly 360 to retract and the anvil assembly 306 to move away from the chamber assembly 308.

[0035] The end effector 304 can have any suitable size, such as 30mm, 45mm, and 60mm, and the setup interface 205 includes options for configuring the distance of each end effector 304 that can be used with the electric surgical suture device 10. (Reference) Figure 1 The electric surgical suture device 10 includes a distance setting interface 205 having a sliding switch 206 and a plurality of switches 205a, 205b, 205c, each switch being associated with a predetermined travel distance of the drive beam 365 during firing, namely 30mm, 45mm, and 60mm. Switches 205a, 205b, 205c may be push-button switches or limit switches, such that when the sliding switch 206 moves within the slit 210, the sliding switch 206 actuates the switch 205a, 205b, 205c corresponding to the desired distance. The slit 210 is defined within the housing 102 of the handle assembly 100. Each switch 208a, 208b, 208b generates a distance signal corresponding to the desired distance. The desired distance signal is transmitted to a controller 406 or directly to a motor 164, which is then configured to rotate a corresponding number of revolutions based on the distance signal to achieve the selected distance. The number of revolutions is pre-programmed into the controller 406 or the drive circuit 404, so there is no need to rely on feedback from sensors 408a to 408n to control the movement of the drive assembly 360.

[0036] Once the loading unit 300 is coupled to the shaft assembly 120, the user inputs the travel distance corresponding to the size of the end effector 304 by moving the sliding switch 206 to engage the corresponding switches 205a, 205b, 205c. If an incorrect switch is pressed, the user can move the switch to the desired position. The position of the sliding switch 206 is indicated by lights 209a, 209b, 209c corresponding to each of the switches 205a, 205b, 205c. Once the distance is set, the user presses button 202, causing the motor 164 to operate in the first direction, for example, rotating clockwise a predetermined number of times to reach the selected distance. The motor 164 actuates the end effector 304 to clamp, suture, and cut the tissue held between the anvil assemblies 306 moving toward the compartment assembly 308. Subsequently, the user presses button 204, causing the motor 164 to operate in the opposite direction the same number of times to retract the drive assembly 360 and move the anvil assemblies 306 away from the compartment assembly 308.

[0037] Another embodiment of the distance setting interface 225 is in Figure 5 As shown, each of switches 225a, 225b, and 225c is a push-button switch, which is manually toggled by the user rather than via a sliding toggle 206. Switches 225a, 225b, and 225c may incorporate an indicator light within the button to indicate their toggling state. In other embodiments, switches 225a, 225b, and 225c may be latching switches, which remain pressed after being toggled. After being toggled, the user then operates the electric surgical stapler 10 by pressing buttons 202 and 204 to turn the end effector 304 on and off. The toggling of switches 225a, 225b, and 225c is reset after the loading unit 300 is removed.

[0038] Another embodiment of the distance setting interface 235 is in Figure 6 As shown in the diagram, distance setting interface 235 is similar to distance setting interface 225 and includes push-button toggle switches 235a and 235b, each associated with different travel distance settings for motor 164. Switches 235a and 235b may also include light indicators and may be lockable, resettable switches as described above. In one embodiment, switch 235a activates motor 164 to operate in a first mode, which may be used for obesity or general purposes, during which motor 164 is continuously operated until it reaches a mechanical limit and stops. Switch 235b activates motor 164 to operate in a second mode, during which motor 164 is operated for a predetermined distance, similar to the distance modes of distance setting interfaces 205 and 225.

[0039] Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is contemplated that elements and features illustrated or described in connection with one exemplary embodiment may be combined with elements and features of another without departing from the scope of this disclosure. Similarly, those skilled in the art will understand other features and advantages of this disclosure based on the foregoing embodiments. Therefore, this disclosure is not limited to what has been specifically shown and described, except as indicated by the appended claims.

Claims

1. A surgical suture device comprising: Loading unit, comprising: A staple cartridge, which has a cartridge spacing and multiple staples; and Anvil, which forms the plurality of nails upon firing; A shaft assembly coupled to the loading unit, the shaft assembly including a drive shaft that is longitudinally movable within the shaft assembly and configured to actuate the loading unit; The handle assembly includes: power supply; An electric motor, coupled to the power source and configured to move the drive shaft longitudinally; and The distance setting interface includes multiple switches, each of which corresponds to a selected travel distance for the motor to move the drive shaft, the selected travel distance corresponding to the bin distance, and... A controller, which is coupled to the distance setting interface; Each of the plurality of switches generates a distance signal, which is transmitted to the controller or directly to the motor, thereby setting the motor to rotate a corresponding number of revolutions based on the distance signal to achieve the selected travel distance.

2. The surgical suture device of claim 1, wherein the distance setting interface includes a sliding switch configured to move within a slit defined in the housing of the handle assembly.

3. The surgical suture device of claim 2, wherein the sliding switch is configured to engage each of the plurality of switches.

4. The surgical suture device of claim 1, wherein each of the plurality of switches includes a light source that is activated in response to engagement of the corresponding switch.

5. The surgical suture device of claim 1, wherein each of the plurality of switches is a lockable push-button switch that can be moved from an unlocked state to a locked state upon actuation.

6. The surgical suture device of claim 5, further comprising a controller coupled to the distance setting interface and configured to reset the locked state of the actuation switch.

7. The surgical suture device of claim 6, wherein the first switch of the plurality of switches is configured to operate the motor in a first mode.

8. The surgical suture device of claim 7, wherein the second switch of the plurality of switches is configured to operate the motor in a second mode.

9. The surgical suture device of claim 8, wherein during the first mode, the motor is configured to longitudinally move the drive shaft until a mechanical limit is reached.

10. The surgical suture device of claim 9, wherein during the second mode, the motor is configured to longitudinally move the drive shaft until the travel distance is reached.

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