Stapling and cutting to default values ​​when strain gauge data integrity is lost.

Abstract

The powered surgical device includes a power source and a motor coupled to the power source. The device may include a transmission assembly movable by the motor. The device may include a sensor configured to monitor movement of the transmission assembly and output sensor data. The device may include a controller configured to determine a position of the transmission assembly and operate the motor based on the position of the transmission assembly and the interruption of the sensor data.

Description

Technical Field

[0001] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to a handheld electromechanical surgical system for performing surgical procedures.

Background Art

[0002] Circular staplers are used in surgical procedures to reattach a previously severed portion of the rectum or similar procedures. Conventional circular clamping, cutting, and stapling instruments include a pistol-type or straight-grip structure having a long shaft extending from the instrument and a staple cartridge supported at the distal end of the long shaft. In this case, the physician can insert the anvil assembly of the circular stapling instrument into the patient's rectum and manipulate the anvil assembly upward along the patient's colon tube toward the severed rectal portion. The physician can further insert the remaining portion of the circular stapling instrument (including the cartridge assembly) through the incision toward the severed rectal portion. The anvil assembly and the cartridge assembly are brought close to each other, staples are discharged from the cartridge assembly toward the anvil assembly, and the staples are formed within the tissue to affect end-to-end anastomosis, and a circular knife is advanced to remove the center of a portion of the clamped tissue portion. After end-to-end anastomosis is affected, the circular stapling device is removed from the surgical site.

[0003] Electric surgical staplers have been developed that utilize one or more motors to clamp, cut, and staple tissue. These staplers also include one or more sensors that provide feedback used when controlling the motors. If sensor feedback is lost during one of the steps (e.g., stapling), a conventional electric stapler may have to interrupt the process, which can lead to a potentially dangerous situation where the stapler becomes stuck to the clamped tissue within it. Staple retrieval can result in tissue loss, and in particular, if the amount of tissue is limited, it may prevent the formation of an anastomosis at that site. [Overview of the project] [Means for solving the problem]

[0004] This disclosure provides an electric stapler having a strain gauge sensor configured to monitor force during a stapling process that discharges multiple staples and / or a cutting process that advances a knife to cut the stapled tissue. If the strain gauge fails during the stapling process, the electric stapler is configured to complete the stapling process and proceed to the cutting process. In particular, if the stapling process reaches a point where stopping staple discharge is more dangerous than continuing without strain gauge feedback and the strain gauge fails. The staple driver is moved to a default staple position, which is determined based on the size of the lumen to be stapled and an offset coefficient based on a variable force, which also depends on the lumen size. Once the stapling process is complete, the electric stapler enters the cutting process, which moves the knife assembly to a default distance based on the tissue gap. The default cutting process is performed at a set low rotation speed to prevent damage to the electric stapler and minimize tissue pressure on the cutting assembly.

[0005] According to one embodiment of the present disclosure, an electrically powered surgical device is disclosed. The surgical device includes a power supply and a motor coupled to the power supply. The device may include a transmission assembly that can be moved by the motor. The device may include a sensor configured to monitor the operation of the transmission assembly and output sensor data. The device may include a controller configured to determine the position of the transmission assembly and to operate the motor based on the position of the transmission assembly and the interruption of sensor data.

[0006] Embodiments of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the controller may further be configured to operate a motor to complete the process in response to the position of the transmission assembly being at or exceeding a threshold position. The controller may further be configured to operate a motor to terminate the process in response to the position of the transmission assembly not reaching a threshold position and the sensor data being interrupted. The surgical device may include a reload configured to selectively couple to the transmission assembly. The reload may include a plurality of staples that can be ejected from the reload by the transmission assembly. The reload may further include a cutting assembly. Completing the process may include advancing the transmission assembly and at least one of ejecting the plurality of staples or advancing the cutting assembly. Terminating the process may include retracting the transmission assembly. The sensor may include a strain gauge that can be configured to measure the force applied to the transmission assembly.

[0007] Another embodiment of the present disclosure discloses an electrically operated surgical device. The surgical device may include a power supply and a motor coupled to the power supply. The device may further include a reload, which has a plurality of staples that can be ejected from the reload and a cutting assembly. The device may also include a staple-retaining transmission assembly that can be moved by the motor to eject the plurality of staples. The device may also include a cutting transmission assembly that can be moved by the motor to advance the cutting assembly. The device may further include a sensor configured to monitor the operation of the staple-retaining transmission assembly and the cutting transmission assembly and to output sensor data. The device may also include a controller configured to determine the positions of the staple-retaining transmission assembly and the cutting transmission assembly. The controller may further be configured to operate the motor to move the staple-retaining transmission assembly based on the position of the staple-retaining transmission assembly and the interruption of sensor data. The controller may further be configured to operate the motor to move the cutting transmission assembly based on the position of the cutting transmission assembly and the interruption of sensor data.

[0008] Embodiments of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the controller may further be configured to operate the motor to complete the stapling process in response to the position of the stapling transmission assembly being at or exceeding a threshold position. Completing the process may include advancing the stapling transmission assembly to release a plurality of staples. The controller may further be configured to operate the motor to terminate the stapling process in response to the position of the stapling transmission assembly not reaching a threshold position and the sensor data being interrupted. Terminating the process may include retracting the stapling transmission assembly. The controller may further be configured to operate the motor to complete the cutting process in response to the position of the cutting transmission assembly being at or exceeding a threshold position. Completing the process may include advancing the cutting transmission assembly. The controller may further be configured to operate the motor to terminate the cutting process in response to the position of the cutting transmission assembly not reaching a threshold position and the sensor data being interrupted. Terminating the process may include retracting the cutting transmission assembly. The sensor may include strain gauges. The strain gauges are configured to measure the forces applied to the stapled transmission assembly and the cut transmission assembly. The present invention provides, for example, the following: (Item 1) A surgical device, Power supply and A motor coupled to the aforementioned power supply, A transmission assembly that can be moved by the aforementioned motor, A sensor configured to monitor the operation of the transmission assembly and output sensor data, It is a controller, Determine the position of the aforementioned transmission assembly, A surgical device comprising: a controller configured to operate the motor based on the position of the transmission assembly and the interruption of the sensor data. (Item 2) The aforementioned controller further, The surgical device according to item 1, configured to operate the motor to complete a process in response to the position of the transmission assembly being at or exceeding a threshold position. (Item 3) The aforementioned controller further, The surgical device according to item 2, wherein the motor is configured to operate to terminate the process in response to the position of the transmission assembly not reaching the threshold position and the sensor data being interrupted. (Item 4) The surgical device according to item 3, further comprising a reload configured to selectively bond to the transmission assembly, wherein the reload includes a plurality of staples that can be ejected from the reload by the transmission assembly. (Item 5) The reload further comprises a cutting assembly, as described in item 4. (Item 6) Completing the process comprises advancing the transmission assembly and at least one of releasing the plurality of staples or advancing the cutting assembly, as described in item 5. (Item 7) Terminating the process includes retracting the transmission assembly, as described in item 6. (Item 8) The sensor is a surgical device as described in item 1, including a strain gauge. (Item 9) The surgical device according to item 8, wherein the strain gauge is configured to measure the force applied to the transmission assembly. (Item 10) A surgical device, Power supply and A motor coupled to the aforementioned power supply, A reload, comprising a plurality of staples and cutting assemblies that can be ejected from the reload, A staple fastening transmission assembly that can be moved by the motor to release the plurality of staples, A cutting transmission assembly that can be moved by the motor to advance the cutting assembly, A sensor configured to monitor the operation of the staple fastening transmission assembly and the cutting transmission assembly and to output sensor data, It is a controller, The positions of the staple fastening transmission assembly and the cutting transmission assembly are determined, Based on the position of the staple fastening transmission assembly and the interruption of the sensor data, the motor is operated to move the staple fastening transmission assembly. A surgical device comprising: a controller configured to operate the motor to move the cutting transmission assembly based on the position of the cutting transmission assembly and the interruption of the sensor data. (Item 11) The aforementioned controller further, The surgical device according to item 10, configured to operate the motor to complete the stapling process in response to the position of the stapling transmission assembly being at or exceeding a threshold position. (Item 12) Completing the process includes advancing the staple fastening transmission assembly to release the plurality of staples, as described in item 11. (Item 13) The aforementioned controller further, The surgical device according to item 11, wherein the motor is configured to terminate the stapling process in response to the position of the stapling transmission assembly not reaching the threshold position and the sensor data being interrupted. (Item 14) Terminating the process includes retracting the staple-fastened transmission assembly, as described in item 13. (Item 15) The aforementioned controller further, The surgical device according to item 10, configured to operate the motor to complete the cutting process in response to the position of the cutting transmission assembly being at or exceeding a threshold position. (Item 16) Completing the process includes advancing the cutting transmission assembly to advance the cutting assembly, as described in item 15. (Item 17) The aforementioned controller further, The surgical device according to item 15, configured to operate the motor to terminate the cutting process in response to the position of the cutting transmission assembly not reaching the threshold position and the sensor data being interrupted. (Item 18) The surgical device according to item 17, wherein terminating the process includes retracting the cutting and transmission assembly. (Item 19) The sensor is a surgical device as described in item 10, including a strain gauge. (Item 20) The surgical device according to item 19, wherein the strain gauge is configured to measure the force applied to the stapled transmission assembly and the cutting transmission assembly. [Brief explanation of the drawing]

[0009] Embodiments of the present disclosure are described herein with reference to the accompanying drawings.

[0010] [Figure 1] This is a perspective view of an electric circular stapler, including a handle assembly, an adapter assembly, and an end effector, according to one embodiment of the present disclosure.

[0011] [Figure 2] Figure 1 is a schematic diagram of the handle assembly, adapter assembly, and end effector.

[0012] [Figure 3] This is a side perspective view of the adapter assembly and end effector, annular reload and anvil assembly attached to the adapter assembly shown in Figure 1, according to an embodiment of the present disclosure.

[0013] [Figure 4] This is a perspective view of the clamp transmission assembly located within the adapter assembly shown in Figure 1, partially indicated by dashed lines.

[0014] [Figure 5]This is a perspective view of the staple-fastened transmission assembly located within the adapter assembly shown in Figure 1, partially indicated by dashed lines.

[0015] [Figure 6] This is a perspective view of the cutting transmission assembly located within the adapter assembly shown in Figure 1, partially indicated by dashed lines.

[0016] [Figure 7] Figure 1 is a cross-sectional view of the end effector reload.

[0017] [Figure 8] A perspective view of an adapter assembly with a strain gauge assembly, shown in partial disassembled form.

[0018] [Figure 9] This is a schematic diagram showing the travel distance and speed of the driver and corresponding motor during a stapling sequence performed by the handheld surgical device of Figure 1, according to one embodiment of the present disclosure.

[0019] [Figure 10] This is a schematic diagram showing the travel distance and speed of the knife assembly and corresponding motor during a cutting sequence performed by the handheld surgical device of Figure 1, according to one embodiment of the present disclosure.

[0020] [Figure 11] This is a flowchart of a method for controlling an electric circular stapler during the stapling process shown in Figure 9, according to an embodiment of the present disclosure.

[0021] [Figure 12] This is a flowchart of a method for controlling an electric circular stapler during the stapling process shown in Figure 10, according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0022] Embodiments of the surgical devices of this disclosure, and adapter assemblies and / or handle assemblies for the surgical devices, are described in detail with reference to the drawings, where similar reference numerals indicate the same or corresponding elements in each of several figures. As used herein, the term “distal” refers to the part or component of a surgical instrument that is further from the user, while the term “proximal” refers to the part or component of a surgical instrument that is closer to the user.

[0023] This disclosure provides an electric circular stapler 10 having a handle assembly, an adapter assembly coupled to the handle assembly, and an end effector coupled to the adapter assembly. The stapler allows for complete independent control of three functions: clamping, stapling, and cutting. This makes it possible for specific parts of the stapler to adapt even when the tissue presents non-ideal conditions.

[0024] Figure 1 shows a surgical device, such as an electric circular stapler 10 for forming an end-to-end anastomosis ("EEA"), which includes, for example, a handle assembly 100 configured for selective connection with an adapter assembly 200. The adapter assembly 200 is configured for selective connection with an end effector 300, which includes a reload 400 and an anvil assembly 500. The end effector 300 is configured to form an anastomosis by connecting two parts of a structure (e.g., intestine, colon) to produce a surgical effect on the patient's tissue, i.e., by clamping, stapling, and cutting the tissue grasped within the end effector 300.

[0025] The handle assembly 100 includes a power handle 101 and an outer shell housing 11 configured to selectively receive and enclose the power handle 101. The shell housing 11 includes a distal half 11a and a proximal half 11b pivotably connected to the distal half 11a. When connected, the distal half 11a and the proximal half 11b define a shell cavity within which the power handle 101 is disposed.

[0026] Although the electric circular stapler 10 is described herein as a modular device comprising several interconnecting components such as a handle assembly 100, a removable shell housing 11, and an adapter assembly 200, the electric circular stapler 10 may be formed, for example, during the manufacture of the electric circular stapler as an integrated device in which one or more of the components are securely attached to one another.

[0027] The distal half 11a and proximal half 11b of the shell housing 11 are divided along a plane that crosses the longitudinal axis "X" of the adapter assembly 200. The distal half 11a of the shell housing 11 defines a connection portion 20 configured to receive the corresponding drive coupling assembly 210 (Figure 3) of the adapter assembly 200. The distal half 11a of the shell housing 11 supports a toggle control button 30. The toggle control button 30 can be actuated in four directions (e.g., left, right, up, and down).

[0028] Referring to Figures 1 and 2, the power handle 101 includes a main controller circuit board 142, a rechargeable battery 144 configured to supply power to any of the electrical components of the handle assembly 100, and a plurality of motors coupled to the battery 144, namely a first motor 152a and a second motor 152b. The power handle 101 also includes a display 146. In embodiments, motors 152a and 152b may be coupled to any suitable power source configured to provide electrical energy to motors 152a and 152b, such as an AC / DC transformer. Each of motors 152a and 152b is coupled to a motor controller 143 that controls the operation of the corresponding motors 152a and 152b, including the flow of electrical energy from the battery 144 to motors 152a and 152b. A main controller 147 is provided to control the power handle 101. The main controller 147 is configured to execute software instructions that implement algorithms disclosed herein, such as a clamping algorithm, a stapling algorithm, and a cutting algorithm, which control the operation of the power handle 101.

[0029] The motor controller 143 includes a plurality of sensors 408a...408n configured to measure the operating status of motors 152a and 152b and battery 144. Sensors 408a-n include strain gauges 408b and may include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. Sensors 408a-408n may measure the voltage, current, and other electrical characteristics of the electrical energy supplied by battery 144. Sensors 408a-408n may also measure the angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operating characteristics of motors 152a and 152b. Sensor 408a also includes an encoder configured to count the rotation or other indicators of motors 152a and 152b, which is then used by the main controller 147 to calculate the linear movement of components movable by motors 152a and 152b. Angular velocity can be determined by measuring the rotation of motors 152a and 152b, or a drive shaft (not shown) coupled to them and rotatable by motors 152a and 152b. The position of the drive shaft, which is movable in various axial directions, can also be determined by using various linear sensors disposed in or near the shaft, or by extrapolating from RPM measurements. In embodiments, torque can be calculated based on the regulated current draw of motors 152a and 152b at a constant RPM. In further embodiments, motor controllers 143 and / or main controllers 147 can measure time and process the above values ​​as a function of time, including integration and / or differentiation, to determine, for example, the rate of change in the measurements. The main controller 147 is also configured to determine the travel distance of various components of the adapter assembly 200 and / or end effector 300 by counting the rotations of motors 152a and 152b.

[0030] The motor controller 143 is coupled to a main controller 147 which includes multiple inputs and outputs for interface with the motor controller 143. In particular, the main controller 147 receives measured sensor signals from the motor controller 143 regarding the operating status of motors 152a and 152b and battery 144, and then outputs control signals to the motor controller 143 to control the operation of motors 152a and 152b based on sensor readings and specific algorithmic instructions. The main controller 147 is also configured to accept multiple user inputs from a user interface (e.g., switches, buttons, touchscreens, etc., coupled to the main controller 147).

[0031] The main controller 147 is also coupled to memory 141. Memory 141 may include volatile (e.g., RAM) and non-volatile storage devices configured to store data including software instructions for operating the power handle 101. The main controller 147 is also coupled to the strain gauge 408b of the adapter assembly 200 using a wired or wireless connection and is configured to receive strain measurements from the strain gauge 408b used during the operation of the power handle 101.

[0032] The power handle 101 includes a number of motors 152a and 152b, each containing its own motor shaft (not explicitly shown) extending from it and configured to drive its own transmission assembly. The rotation of the motor shaft by each motor functions to drive the shaft and / or gear components of the adapter assembly 200 to perform various operations of the handle assembly 100. In particular, the motors 152a and 152b of the power handle 101 are configured to drive the shaft and / or gear components of the adapter assembly 200 to selectively extend / retract the trocar member 274 (Figure 4) of the trocar assembly 270 of the adapter assembly 200. Extending / retracting the trocar member 274 opens and closes the end effector 300 (when the anvil assembly 500 is connected to the trocar member 274 of the trocar assembly 270), starts the annular array of staples 423 of the reload 400, and moves the annular knife 444 of the reload 400.

[0033] The reload 400 includes a storage device 402 configured to store operating parameters of the reload 400, including the starting clamping force, maximum clamping force, and force coefficient. Each type of reload 400 may have a corresponding starting clamping force, which can be automatically obtained by the main controller 147 by reading it from the storage device 402, and / or manually set by the user by directly selecting either the type of reload 400 or the clamping force. The starting clamping force may be any preferred threshold between approximately 100 pounds and approximately 200 pounds, and in embodiments, the target clamping force may be approximately 150 pounds. In embodiments, a 33 mm size reload 400 may have a clamping force of approximately 150 lbs.

[0034] Referring here to Figures 3 and 4, the adapter assembly 200 includes an outer knob housing 202 and an outer tube 206 extending from the distal end of the knob housing 202. The knob housing 202 and the outer tube 206 are configured and dimensionally determined to accommodate the components of the adapter assembly 200. The knob housing 202 includes an electrical connector 312 and a memory device 310 coupled thereto. The memory device 310 is configured to store various operating parameters relating to the adapter assembly 200. The adapter assembly 200 is configured to convert the rotation of the coupling shaft (not explicitly shown) of the handle assembly 100 into axial translation useful for operating the trocar assembly 270, the anvil assembly 500, and / or the staple driver 430 or knife assembly 440 of the reload 400 of the adapter assembly 200.

[0035] The adapter assembly 200 further includes a trocar assembly 270 detachably supported at the distal end of the outer tube 206. The trocar assembly 270 includes a trocar member 274 and a drive screw 276 operably received within the trocar member 274 for axial movement of the trocar member 274 relative to the outer tube 206. The distal end 274b of the trocar member 274 is configured to selectively engage with the anvil assembly 500, so that axial movement of the trocar member 274 via rotation of the drive screw 276 results in accompanying axial movement of the anvil assembly 500.

[0036] Referring to Figure 4, the clamp transmission assembly 240 includes a first rotatable proximal drive shaft 212 coupled to one of the motors 152a and 152b, a second rotatable proximal drive shaft 281, a rotatable distal drive shaft 282, and a coupling member 286, each of which is supported within the outer tube 206 of the adapter assembly 200. The clamp transmission assembly 240 functions to extend / retract the trocar member 274 of the trocar assembly 270 of the adapter assembly 200, and to open / close the anvil assembly 510 when the anvil assembly 510 is connected to the trocar member 274.

[0037] Referring to Figure 5, the adapter assembly 200 includes a staple-fastening transmission assembly 250 for interconnecting the first motor 152a and a second axially translatable drive member of the reload 400, the staple-fastening transmission assembly 250 converts and transmits the rotation of the first motor 152a to the axial translation of the outer flexible band assembly 255 of the adapter assembly 200, and then transmits it to the staple driver 430 of the reload 400, the staple driver 430 of the reload 400, and starts staples 423 from the reload 400 and to the anvil assembly 510.

[0038] The staple-fastening transmission assembly 250 of the adapter assembly 200 includes an outer flexible band assembly 255 fixed to a staple driver coupler 254. A second rotatable proximal drive shaft 220 is coupled to a second motor 152b and configured to actuate the staple driver coupler 254, which converts rotational motion into longitudinal motion. The outer flexible band assembly 255 includes first and second flexible bands 255a, 255b that are laterally spaced apart and connected at their proximal ends to a support ring 255c and at their distal ends to the proximal end of a distal pusher 255d. Each of the first and second flexible bands 255a, 255b is attached to the support ring 255c and the distal pusher 255d. The outer flexible band assembly 255 further includes first and second connecting extensions 255e, 255f that extend proximal from the support ring 255c. The first and second connecting extensions 255e and 255f are configured to operably connect the outer flexible band assembly 255 to the staple driver coupler 254 of the staple fastening transmission assembly 250.

[0039] The adapter assembly 200 also includes a cutting transmission assembly 260 for interconnecting a second motor 152b and the annular knife 444 of the reload 400, the cutting transmission assembly 260 converts and transmits the rotation of one of the second motors 152b into axial translation of the outer flexible band assembly 265 of the adapter assembly 200, and the knife carrier 442 of the reload 400 then advances the annular knife 444 from the reload 400 and toward the anvil assembly 510.

[0040] The internal flexible band assembly 265 includes first and second flexible bands 265a and 265b, which are spaced laterally apart and connected at their proximal ends to the support ring 265c and at their distal ends to the proximal end of the support base 265d. Each of the first and second flexible bands 265a and 265b is attached to the support ring 265c and the support base 265d.

[0041] The internal flexible band assembly 265 further includes first and second connecting extensions 265e, 265f that extend proximal to the support ring 265c. The first and second connecting extensions 265e, 265f are configured to operably connect the internal flexible band assembly 265 to the knife driver 264 of the cutting transmission assembly 260. The support base 265d extends distally from the flexible bands 265a, 265b and is configured to connect to the knife assembly 440 of the reload 400.

[0042] Referring to Figure 7, the staple driver 430 of the reload 400 includes a staple cartridge 420 having a driver adapter 432 and a driver 434. The proximal end 432a of the driver adapter 432 is configured for selective contact and abutment with the distal pusher 255d of the outer flexible band assembly 255 of the staple fastening transmission assembly 250 of the adapter assembly 200. During operation, as the outer flexible band assembly 255 advances distally, the distal pusher 255d of the outer flexible band assembly 255 contacts the proximal end 432a of the driver adapter 432, as described above, to advance the driver adapter 432 and the driver 434 from a first or proximal position to a second or distal position. The driver 434 includes a plurality of driver members 436 aligned with the staple pocket 421 of the staple cartridge 420 for contact with staples 423. Therefore, the forward movement of the driver 434 relative to the staple cartridge 420 causes the staples 423 to be released from the staple cartridge 420.

[0043] The knife assembly 440 of the reload 400 includes a knife carrier 442 and an annular knife 444 fixed around the distal end 442b of the knife carrier 442. The proximal end 442a of the knife carrier 442 is configured to engage with the support base 265d of the inner flexible band assembly. During operation, as the inner flexible band assembly 265 advances distally, the support base 265d of the inner flexible band assembly 265 connects with the proximal end 442a of the knife carrier 442, advancing the knife carrier 442 and the annular knife 444 from a first or proximal position to a second or advanced position, causing the cutting of tissue disposed between the staple cartridge 420 and the anvil assembly 510.

[0044] The forces during the operation of the trocar member 274, the closing of the end effector 300 (e.g., the retraction of the anvil assembly 500 relative to the reload 400), the release of the staples 423 from the reload 400, and the forward movement of the knife assembly 440 may be measured by strain gauges 408b to monitor and control various processes such as the initiation of the staples 423 from the reload 400, to monitor the forces during the initiation and formation of the staples 423 when the staples 423 are being released from the reload 400, to optimize the formation of the staples 423 (e.g., staple crimp height) when the staples 423 are being released from the reload 400 for different structural indicators, and to monitor and control the initiation of the annular knife of the reload 400.

[0045] Referring to Figure 8, the strain gauge 408b of the adapter assembly 200 is housed within the strain gauge housing 320. The strain gauge 408b measures and monitors the retraction of the trocar member 274, as well as the release and formation of staples 423 from the reload 400. During the closing of the end effector 300, when the anvil assembly 500 comes into contact with tissue, obstacles, the tissue contact surface of the reload 400, staple release, etc., a reaction force is applied to the anvil assembly 500, which is generally directed distally. This distally directed reaction force is transmitted from the anvil assembly 500 to the strain gauge 408b. The strain gauge 408b then communicates a signal to the main controller circuit board 142 of the power handle 101 of the handle assembly 100. The graphic (Figure 8) is then displayed on the display 146 of the handle assembly 100 to provide the user with real-time information regarding the starting status of the handle assembly 100.

[0046] The trocar assembly 270 is fixed axially and rotatably within the outer tube 206 of the adapter assembly 200. Referring to Figure 8, the adapter assembly 200 includes a support block 292 fixedly disposed within the outer tube 206. The strain gauge housing 320 is disposed between the support block 292 and the connector sleeve 290. The reload 400 is removably coupled to the connector sleeve 290.

[0047] During operation, the strain gauge 408b of the adapter assembly 200 measures and monitors the retraction of the trocar member 274 as it passes through the strain gauge 408b. Since the first and second flexible bands 255a, 255b also pass through the strain gauge 408b, the strain gauge 408b of the adapter assembly 200 also measures and monitors the release of staples 423 from the reload 400. During clamping, stapling, and cutting, reaction forces are applied to the anvil assembly 500 and the reload 400, and these reaction forces are transmitted to the support block 292, which then transmits these reaction forces to the strain sensor of the strain gauge 408b.

[0048] The strain sensor of the strain gauge 408b can be any device configured to measure the strain (a dimensionless quantity) in the object to which it is bonded (e.g., the support block 292), and as a result, when the object deforms, the metal foil of the strain sensor also deforms, changing its electrical resistance, which is then used to calculate the load experienced by the trocar assembly 270. The strain gauge 408b provides closed-loop feedback to the starting / clamping loads indicated by the first, second and third force / rotation transmission / conversion assemblies.

[0049] Next, the strain sensor of the strain gauge 408b communicates a signal to the main controller circuit board 142. Then, the figure is displayed on the display 146 of the power pack core assembly 106 of the handle assembly 100 to provide the user with real-time information about the starting status of the handle assembly 100. The strain gauge 408b is also electrically connected to the electrical connector 312 (Figure 3) via the proximal harness assembly 314 and the distal harness assembly 316.

[0050] Further details regarding the configuration and operation of the circular stapler and its components can be found in International Application US / 2019 / 040440, filed on 3 July 2019, which is incorporated herein by reference in its entirety.

[0051] During operation, the anvil assembly 500 (already positioned by the surgeon) is attached to the trocar member 274, and the user initiates the clamping process for the tissue sandwiched between the reload 400 and the anvil assembly 500 by pressing the bottom portion of the toggle control button 30. During clamping, the anvil assembly 500 is retracted toward the reload 400 until it reaches a preset fully clamped position, i.e., the position of the anvil assembly 500 where the tissue is fully clamped between the anvil assembly 500 and the reload 400. The preset fully clamped position varies for each of the different types of reloads. While clamping, the strain gauge assembly 408b continuously provides the main controller 147 with measurements of the force applied to the trocar member 274 as the trocar member 274 moves the anvil assembly 500 to clamp the tissue between the anvil assembly 500 and the reload 400.

[0052] The user initiates the surgical procedure by positioning the adapter assembly 200, which includes the trocar member 274 and the anvil assembly 510, within the colorectal or upper gastrointestinal region. The user presses the toggle control button 30 to extend the trocar member 274 until it penetrates the tissue. After the trocar member 274 is extended, the anvil assembly 510, previously positioned by the surgeon, is attached to the trocar member 274, and the user initiates the clamping process for the tissue sandwiched between the reload 400 and the anvil assembly 510 by pressing the bottom portion of the toggle control button 30. Once the clamping is successfully completed, the user initiates the stapling sequence.

[0053] To start the stapling sequence, the user presses one of the safety buttons 36 on the power handle 101. The safety button 36 acts as a safety device, activating the toggle control button 30 and initiating stapling. When the safety button 36 is activated, a rotational verification calibration check is performed. The display 146 transitions to a stapling sequence display, which includes a circle showing an animation of the circular anastomosis, a progress bar, and a staple icon. The stapling sequence screen remains displayed until the user starts or ends the stapling sequence, or removes the clamp.

[0054] To initiate the stapling sequence, the user presses the toggle control button 30, which moves the stapling transmission assembly 250, converting its rotation into linear motion, and releasing and forming the staples 423 from the circular reload 400. In particular, during the starting sequence, the first motor 152a uses the stapling transmission assembly 250 to advance the driver 434. The force applied to the stapling transmission assembly 250 is monitored by the strain gauge 408b. The process is considered complete when the stapling transmission assembly 250 reaches the target stapling position corresponding to the stapling stroke information stored on the memory device 402 of the reload 400 and the force compensation factor detected by the strain gauge 408b. This indicates that the staples 423 have been successfully released and deformed relative to the anvil assembly 510.

[0055] Referring to Figure 9, the distance and speed of the first motor 152a when advancing the driver 434 within the reload 400 are schematically shown. The staple driver is initially advanced at a first speed from a first position 608 (e.g., hard stop) to a second position 610 (e.g., base position) for a first segment. From the second position 610, the driver 434 advances at a second speed, slower than the first speed, until it reaches a third position 612 (e.g., target staple position), releasing the staples 423.

[0056] After reaching the second position 610, the first motor 152a operates at a second, slower speed to release the staple 423 from the reload 400. During the second segment, as the staple 423 is released from the reload 400 and staples the tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 408b and determines whether the force corresponding to the measured strain is between the minimum and maximum stapling forces. The range of stapling forces may be stored in the memory device 402 of the reload 400 and can be used by the main controller 147 during the stapling sequence. The determination of whether the measured force is below the minimum stapling force is used to verify that the staple 423 is present in the reload 400. In addition, a low force may also indicate a failure of the strain gauge 408b. If the measured force is below the minimum stapling force, the main controller 147 signals the first motor 152a to retract the driver 434 to the second position 610. The main controller 147 also displays a sequence on the display 146 instructing the user to terminate the stapling sequence and retract the anvil assembly 510. After removing the anvil assembly 510, the user can replace the circular adapter assembly 200 and reload 400 and restart the stapling process.

[0057] If the measured force exceeds the maximum stapling force, which may be approximately 580 pounds, the main controller 147 displays a sequence on the display 146 instructing the user to stop the first motor 152a and terminate the stapling sequence. However, the user can continue the stapling process without force limit detection by pressing the toggle control button 30.

[0058] The main controller 147 determines that the stapling process is successfully completed if the first motor 152a reaches a third position 612 associated with the stapled tissue, and the strain measured during this movement is within the limits of the minimum and maximum stapling force. The first motor 152a then retracts the driver 434 to a fourth position 614 to release the pressure on the tissue before initiating the cutting sequence.

[0059] Referring to Figure 10, the distance and speed of the second motor 152b when advancing the knife assembly 440 are schematically shown. The knife assembly 440 first advances from the first position 616 to the second position 618 by a first segment at a first speed. From the second position 618, the knife assembly 440 advances at a second speed, which is slower than the first speed, until it reaches the third position 620, cutting the stapled tissue.

[0060] During the first segment, the second motor 152b advances the knife assembly 440 until it contacts the stapled tissue. After reaching the second position 618, the third motor 154 operates at a second slower speed to cut the stapled tissue. As the knife assembly 440 advances to cut the tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 320 and determines whether the force corresponding to the measured strain is between the target cutting force and the maximum cutting force. The target cutting force and the maximum cutting force may be stored in the storage device 405 of the reload 400 and may be used by the main controller 147 during the cutting sequence. If the target cutting force is not reached during the cutting sequence and this indicates an improper cut, the main controller 147 signals the second motor 152b to retract the knife assembly 440, allowing the user to open the reload 400 and abort the cutting sequence. The main controller 147 also displays on the display 146 a sequence instructing the user to terminate the cutting sequence and retract the anvil assembly 510. After removing the anvil assembly 510, the user can replace the circular adapter assembly 200 and reload 400 and resume the stapling process. If the measured force exceeds the maximum cutting force, the main controller 147 displays on the display 146 a sequence instructing the user to stop the second motor 152b and terminate the cutting sequence.

[0061] Referring to Figures 11 and 12, the motorized circular stapler 10 is configured to operate during the stapling and cutting process when the main controller 147 is no longer receiving data from the strain gauge 408b due to, for example, a failure of the strain gauge 408b or an input / output error between the strain gauge 408b and the main controller 147. Figure 10 shows the process for operating the motorized circular stapler 10 during the stapling process when the sensor data flow is interrupted. First, the stapling process is started by toggling the control button 30. An interruption in sensor data can be defined as a loss of sensor data for a predetermined period, i.e., about 1 second to about 5 seconds, so that the main controller 147 does not take corrective action due to a temporary interruption. The main controller 147 continuously receives strain data from the strain gauge 408b during the stapling process. As used herein, “continuously” refers to sampling and / or polling of the strain gauge 408b at any preferred rate. If the data flow is not interrupted, the main controller 147 continues the stapling process as described above with respect to Figure 9. However, if the strain data flow is interrupted for any reason, the main controller 147 checks whether the staple driver 434 is at a threshold position 611 between the second position 612 and the third position 614. The threshold position 611 can be determined based on the size of the lumen, i.e., the circumference of the reload 400, as well as sensor data collected during the tissue clamping process. The distance check is based on distance data from the encoder or any other suitable position sensor. Therefore, if the strain data flow is interrupted before the staple driver 434 reaches the threshold position 611, the stapling process is terminated and the staple driver 434 is retracted. However, if the strain data flow is interrupted while the staple driver 434 is advancing from the threshold position 611 to the third position 614, the main controller 147 continues the stapling process and the staple driver 434 is allowed to advance without interruption. When the staple driver 434 reaches the third position 612, the retraction process of the staple driver is performed as described above with respect to Figure 9.

[0062] Figure 12 shows the process for operating the electric circular stapler 10 during the cutting process in the event of an interruption in the sensor data flow. During the cutting process, just as in the stapling process, the main controller 147 continuously receives strain data from the strain gauge 408b. If the data flow is not interrupted, the main controller 147 continues the cutting process as described above with respect to Figure 10. However, if the strain data flow is interrupted for any reason, the main controller 147 checks whether the knife assembly 440 is at a second position 618 (e.g., the base position) corresponding to the threshold position. The threshold position can be determined based on the size of the lumen, i.e., the circumference of the reload 400, as well as the sensor data collected during the tissue clamping process. Therefore, if the strain data flow is interrupted before the knife assembly 440 reaches or is at the threshold position, the cutting process is terminated and the knife assembly 440 is retracted. However, if the strain data flow is interrupted while the knife assembly 440 is advancing from the second position 618, i.e., past the threshold position to the third position 620 corresponding to the completion of cutting, the main controller 147 continues the cutting process and the knife assembly 440 is advanced without interruption. When the knife assembly 440 reaches the third position 618, the retraction process is performed as described above with respect to Figure 10. If the sensor data is interrupted during the stapling process, the cutting process may also be performed as described above. This allows the stapling and cutting processes to be completed even if the sensor data is interrupted.

[0063] It will be understood that various modifications can be made to the embodiments of the adapter assemblies described herein. Therefore, the above description should not be construed as limiting, but merely as illustrative of embodiments. Those skilled in the art will anticipate other modifications within the scope and spirit of this disclosure.

[0064] In one or more embodiments, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. When implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include non-temporary computer-readable media corresponding to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0065] Instructions may be executed by one or more processors, such as digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated circuits or discrete logic circuits. Therefore, the term "processor," as used herein, may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described technology. Furthermore, the technology may be fully implemented by one or more circuits or logic elements.

Claims

1. A surgical device, Power supply and A motor coupled to the aforementioned power supply, A transmission assembly that can be moved by the motor, the transmission assembly includes either a stapled transmission assembly or a cut transmission assembly, A sensor configured to monitor the operation of the transmission assembly and output sensor data, A controller, wherein the controller is Determining the position of the aforementioned transmission assembly, The motor is operated based on the position of the transmission assembly and the interruption of the sensor data. A controller and Surgical devices, including [specific components].

2. The aforementioned controller further, The surgical device according to claim 1, wherein the motor is configured to operate to complete a process in response to the position of the transmission assembly being at or exceeding a threshold position, the process being a stapling process if the transmission assembly is a stapling transmission assembly, and the process being a cutting process if the transmission assembly is a cutting transmission assembly.

3. The aforementioned controller further, The surgical device according to claim 2, wherein the motor is configured to operate the process in response to the position of the transmission assembly not reaching the threshold position and the sensor data being interrupted, the process being terminated during the process without completing the process, the process being a stapling process if the transmission assembly is a stapling transmission assembly, and the process being a cutting process if the transmission assembly is a cutting transmission assembly.

4. The surgical device according to claim 3, further comprising a reload configured to be selectively coupled to the transmission assembly, the reload comprising a plurality of staples that can be ejected from the reload by the transmission assembly.

5. The surgical device according to claim 4, wherein the reload further comprises a cutting assembly.

6. Completing the process comprises advancing the transmission assembly and at least one of releasing the plurality of staples or advancing the cutting assembly, according to claim 5.

7. The surgical device according to claim 6, wherein terminating the process includes retracting the transmission assembly.

8. The surgical device according to claim 1, wherein the sensor includes a strain gauge.

9. The surgical device according to claim 8, wherein the strain gauge is configured to measure the force applied to the transmission assembly.

10. A surgical device, Power supply and A first motor coupled to the power supply, A second motor coupled to the power supply, wherein the second motor is different from the first motor, A reload, wherein the reload includes a plurality of staples and a cutting assembly that can be ejected from the reload, A staple fastening transmission assembly that can be moved by the first motor to release the plurality of staples, A cutting transmission assembly that can be moved by the second motor to advance the cutting assembly, A sensor configured to monitor the operation of the staple fastening transmission assembly and the cutting transmission assembly and to output sensor data, A controller, wherein the controller is Determining the positions of the staple fastening transmission assembly and the cutting transmission assembly, Based on the interruption of the position of the staple fastening transmission assembly and the sensor data, the first motor is operated to move the staple fastening transmission assembly. Based on the position of the cutting transmission assembly and the interruption of the sensor data, the second motor is operated to move the cutting transmission assembly. A controller and Surgical devices, including [specific components].

11. The aforementioned controller further, The surgical device according to claim 10, wherein the first motor is configured to operate to complete the stapling process in response to the position of the stapling transmission assembly being at or exceeding a threshold position.

12. Completing the stapling process comprises advancing the stapling transmission assembly to release the plurality of staples, according to claim 11.

13. The aforementioned controller further, The surgical device according to claim 11, wherein the first motor is configured to operate in response to the position of the staple fastening transmission assembly not reaching the threshold position and the sensor data being interrupted, so as to terminate the stapling process without completing the stapling process during the stapling process.

14. The surgical device according to claim 13, wherein terminating the stapling process includes retracting the stapling transmission assembly.

15. The aforementioned controller further, The surgical device according to claim 10, wherein the second motor is configured to operate to complete the cutting process in response to the position of the cutting transmission assembly being at or exceeding a threshold position.

16. The surgical device according to claim 15, wherein completing the cutting process includes advancing the cutting transmission assembly to advance the cutting assembly.

17. The aforementioned controller further, The surgical device according to claim 15, wherein the second motor is configured to operate in response to the position of the cutting transmission assembly not reaching the threshold position and the sensor data being interrupted, so as to terminate the cutting process without completing the cutting process during the cutting process.

18. The surgical device according to claim 17, wherein terminating the cutting process includes retracting the cutting transmission assembly.

19. The surgical device according to claim 10, wherein the sensor includes a strain gauge.

20. The surgical device according to claim 19, wherein the strain gauge is configured to measure the force applied to the stapled transmission assembly and the cutting transmission assembly.

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