Handheld electromechanical surgical system with low tissue compression indication

Abstract

A surgical device includes a reloader assembly having a plurality of staples and a storage device that stores data including a minimum gripping force limit. The surgical device also includes an anvil assembly movable relative to the reloader assembly, a power source, and a motor coupled to the power source. The surgical device further includes a transmission assembly movable under the action of the motor and configured to move the anvil assembly relative to the reloader assembly. The surgical device also includes a force sensor configured to measure a force exerted by the transmission assembly on the anvil assembly. The surgical device also includes a controller configured to activate the motor to move the anvil assembly relative to the reload assembly; comparing the measured force with a minimum clamping force limit; and outputting an alert in response to the measured force being below the minimum gripping force limit.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 393,326, filed on July 29, 2022. The entire disclosure of the foregoing application is incorporated herein by reference. background 1. Technical Field

[0002] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to handheld electromechanical surgical systems for performing surgical procedures. 2. Related technical background

[0003] Circular staplers are used in surgical procedures for reattaching previously transected rectal sections or in similar procedures. The circular clamping, cutting and suturing instrument can be manually actuated and can include a pistol-type or linear grip-type structure having an elongated shaft extending therefrom and a staple cartridge supported on the distal end of the elongated shaft. The doctor can insert the anvil assembly of the circular suturing instrument through the incision and toward the transected rectal section. The doctor can also insert the rest of the circular suturing instrument (including the cartridge assembly) into the patient's rectum and manipulate the instrument along the patient's colon toward the transected rectal section. The anvil assembly and the cartridge assembly are brought closer to each other, and the staples are discharged from the cartridge assembly toward the anvil assembly to form the staples in the tissue, thereby achieving end-to-end anastomosis, and the annular knife is advanced to core a portion of the clamped tissue section. After completing the end-to-end anastomosis, the circular suturing device is removed from the surgical site. An electric surgical stapler has also been developed, and the electric surgical stapler utilizes one or more motors to clamp, cut and suturing tissue. Due to differences in patient anatomy, the thickness of the tissue being sutured varies considerably. Therefore, it is necessary to determine the thickness of the tissue during the suture procedure. Summary of the invention

[0004] The present disclosure provides an electric circular stapler configured to operate in four sequences (i.e., clamping, suturing, cutting, and releasing) to form an anastomosis by connecting two parts of a structure (e.g., intestine, colon, etc.). The electric circular stapler includes a handle assembly having a power source and one or more motors coupled to the power source. The stapler also includes an adapter assembly having a plurality of transmission assemblies, such as a drive shaft, that transmit actuation from an electric handle. The electric handle assembly and the adapter assembly may be reusable.

[0005] The electric surgical stapler operates in four stages, namely clamping, suturing, cutting, and loosening. Clamping is accomplished by moving the anvil in a proximal direction to compress the tissue between the anvil and a reloader assembly comprising a plurality of staples. The anvil and reloader assembly may be disposable. During the suturing process, the staples are ejected from the reloader assembly into the clamped tissue and deformed against the anvil. Cutting includes moving an annular knife through the compressed and sutured tissue until the knife contacts the anvil. During loosening, the anvil assembly moves distally away from the cut tissue and the reloader assembly.

[0006] Each of the clamping phase, suturing phase, cutting phase, and loosening phase can be monitored to ensure the correct operation of the electric surgical stapler, including the correct release of the anvil after the cutting process is completed. The electric surgical stapler includes a sensor (e.g., a strain gauge) configured to measure force during each process, and a controller configured to monitor force and detect any abnormalities during the operation of the electric surgical stapler. The electric stapler is configured to operate with a plurality of reloaders of different sizes and anvils of corresponding sizes, and the reloader can have a diameter from about 20 mm to about 35 mm. The minimum clamping force can be stored in the device software resident on the handle or in any other suitable location, such as a cloud service. In an embodiment, each reloader may include a storage device that stores various parameters including the minimum clamping force limit.

[0007] The electric surgical stapler is configured to monitor the clamping force during surgery and determine the thickness of the tissue compressed between the anvil and the reloader. This allows the user to select a more appropriate end effector (e.g., downsized) that fits the lower thickness indication to ensure better results and less likelihood of leakage. Therefore, the present disclosure provides a method for determining whether the tissue compression pressure is lower than the pressure recommended for the selected end effector and communicating this information to the surgeon before firing. This allows the surgeon to make more informed decisions based on immediate feedback from the device.

[0008] The method includes establishing a minimum clamping force limit for each size of the end effector, so that for all sizes of end effectors, the equivalent "lower pressure limit" is the same, because the pressure is calculated by dividing the applied force by the surface area of ​​the end effector. Since the surface area in contact with the tissue varies for different end effectors, a different "minimum clamping force limit" is established for each end effector, so that the "lower tissue pressure limit" is the same for all sizes. Therefore, when clamped to the specified tissue gap for the particular end effector, if the final clamping force at the specified tissue gap is lower than the minimum clamping force limit, the electric surgical stapler displays or provides some other indication to the user, that is, the tissue pressure may be too low and alerts them that they may need to assess the situation and make an informed decision, whether to fire, reduce the size, or produce anastomosis in some other way (e.g., suture, etc.).

[0009] According to one embodiment of the present disclosure, a surgical device is disclosed. The surgical device includes a reloader assembly having a plurality of nails. The surgical device also includes an anvil assembly movable relative to the reloader assembly, a power source, and a motor connected to the power source. The surgical device further includes a transmission assembly that is movable under the action of the motor and is configured to move the anvil assembly relative to the reloader assembly. The surgical device also includes a force sensor and a storage device, the force sensor being configured to measure the force applied by the transmission assembly to the anvil assembly, and the storage device storing data including a minimum clamping force limit. The surgical device also includes a controller configured to: enable the motor to move the anvil assembly relative to the reloader assembly; compare the measured force with the minimum clamping force limit; and output an alarm in response to the measured force being lower than the minimum clamping force limit.

[0010] Implementations of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the data may further include a clamping distance. The controller may be further configured to enable the motor to move the anvil assembly relative to the reloader assembly until the clamping distance is reached. The controller may also be configured to compare the force measured at the clamping distance with the minimum clamping force limit. The controller may be further configured to enable multiple nails to be ejected in response to the measured force being higher than the minimum clamping force limit. The controller may also be configured to determine an alternative reloader assembly in response to the measured force being lower than the minimum clamping force limit. The surgical device may also include a display screen configured to display at least one of an alarm or information related to an alternative reloader.

[0011] According to another embodiment of the present disclosure, a method for controlling a surgical device is disclosed. The method includes receiving a minimum clamping force limit stored in a storage device at a controller. The method also includes enabling a motor to move a transmission assembly connected to an anvil assembly, the anvil assembly being movable relative to a reloader assembly having a plurality of nails. The method further includes measuring a force applied to the anvil assembly by the transmission assembly via a force sensor. The method also includes comparing the measured force with the minimum clamping force limit at the controller. The method further includes outputting an alarm by the controller in response to the measured force being lower than the minimum clamping force limit.

[0012] Implementations of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the method may further include receiving a clamping distance stored in a storage device of a reloader at a controller. The method may also include enabling a motor to move the anvil assembly relative to the reloader assembly until the clamping distance is reached. The method may additionally include comparing the force measured at the clamping distance with a minimum clamping force limit at the controller. The method may further include enabling the discharge of multiple nails in response to the measured force being higher than the minimum clamping force limit. The method may also include determining an alternative reloader assembly at the controller in response to the measured force being lower than the minimum clamping force limit. The method may further include outputting an alarm or at least one of information related to an alternative reloader on a display screen.

[0013] According to another embodiment of the present disclosure, a surgical device is disclosed. The surgical device includes a reloader assembly having a plurality of nails and a storage device storing data related to the reloader assembly. The data includes a minimum clamping force limit and a clamping distance. The device also includes an anvil assembly that is movable relative to the reloader assembly. The device further includes a power supply and a motor connected to the power supply. The device further includes a transmission assembly that is movable under the action of the motor and is configured to move the anvil assembly relative to the reloader assembly. The device further includes a force sensor configured to measure the force applied by the transmission assembly to the anvil assembly. The device further includes a display and a controller configured to: enable the motor to move the anvil assembly relative to the reloader assembly until the clamping distance is reached; compare the force measured at the clamping distance with the minimum clamping force limit; and output an alarm on the display in response to the measured force being lower than the minimum clamping force limit.

[0014] Implementations of the above embodiments may include one or more of the following features.

[0015] In another embodiment, if the clamping force is below the minimum clamping force limit when the anvil reaches the normal clamping distance, the stapler can continue to move the anvil toward the reloader in the proximal direction, move to below the normal clamping distance, and then stop clamping when the minimum clamping force is reached. At this point, the stapler displays or provides some other indication to the user, that is, they may need to assess the situation and make an informed decision, whether to fire, reduce the size, or produce anastomosis in some other way (e.g., line suturing, etc.). If they choose to fire under this reduced clamping gap condition, the device will adjust the suturing and cutting strokes to compensate for the more proximal position of the anvil to ensure that good staple formation and anastomotic cutting are achieved under this reduced gap state, and the reduced gap is less than the normal clamping gap. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which:

[0017] Figure 1 is a perspective view of an electric circular stapler according to an embodiment of the present disclosure, the electric circular stapler including a handle assembly, an adapter assembly, and an end effector;

[0018] Figure 2 yes Figure 1 Schematic diagram of a handle assembly, an adapter assembly, and an end effector;

[0019] Figure 3 According to the embodiments of the present disclosure Figure 1 an adapter assembly and end effector, and a side perspective view of an annular reloader and anvil assembly attached to the adapter assembly;

[0020] Figure 4 Is set in Figure 1 A perspective view of a clamping drive assembly within an adapter assembly, partially shown in phantom;

[0021] Figure 5 Is set in Figure 1 A perspective view of a suture drive assembly within an adapter assembly, partially shown in phantom;

[0022] Figure 6 Is set in Figure 1 A perspective view of a cutting drive assembly within an adapter assembly, partially shown in phantom;

[0023] Figure 7 yes Figure 1 A cross-sectional view of a reloader of an end effector;

[0024] Figure 8 is a perspective view of an adapter assembly with a strain gauge assembly, the adapter assembly being shown partially disassembled; and

[0025] Fig.9A and Fig. 9B is a flow chart of a method for determining an indication of low tissue compression according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0026] Embodiments of the presently disclosed surgical device and adapter assembly, and / or handle assembly for a surgical device are described in detail with reference to the accompanying drawings, in which like reference numerals represent identical or corresponding elements in each of the several views. As used herein, the term "distal" refers to that portion of a surgical instrument or a component thereof that is further away from a user, and the term "proximal" refers to that portion of a surgical instrument or a component thereof that is closer to a user.

[0027] The present 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 complete, independent control of the following four functions: clamping, suturing, cutting, and loosening. This allows certain portions of the stapler to adapt when tissue presents non-ideal conditions.

[0028] Figure 1 A surgical device, such as an electric circular stapler 10 for forming an end-to-end anastomosis (“EEA”), is shown, which includes a handle assembly 100 configured to selectively connect to an adapter assembly 200. The adapter assembly 200 is configured to selectively connect to an end effector 300, which includes a reloader 400 and an anvil assembly 500. The end effector 300 is configured to produce a surgical effect on the patient's tissue, i.e., to connect two parts of a structure (e.g., intestine, colon, etc.) to form an anastomosis by clamping, stapling and cutting tissue grasped within the end effector 300.

[0029] The handle assembly 100 includes an electric handle 101 and an outer cover shell 11, which is configured to selectively receive and enclose the electric handle 101. The cover shell 11 includes a distal half section 11a and a proximal half section 11b pivotally connected to the distal half section 11a. The distal half section 11a and the proximal half section 11b define a cover cavity therein when connected, and the electric handle 101 is disposed in the cover cavity.

[0030] Although the electric circular stapler 10 is described herein as a modular device including a plurality of interconnected components (such as the handle assembly 100, the removable cover housing 11, and the adapter assembly 200, etc.), the electric circular stapler 10 can be formed as an integrated device in which one or more components are securely attached to each other, for example, during manufacture of the electric circular stapler.

[0031] The distal half-section 11a and the proximal half-section 11b of the cover body 11 are separated along a plane that passes through the longitudinal axis "X" of the adapter assembly 200. The distal half-section 11a of the cover body 11 defines a connecting portion 20 that is configured to receive a corresponding drive coupling assembly 210 ( Figure 3 ). The distal half-section 11a of the housing body 11 supports a toggle control button 30. The toggle control button 30 can be actuated in four directions (eg, left, right, up, and down).

[0032] refer to Figure 1 and Figure 2 The electric handle 101 includes a main controller circuit board 142, a rechargeable battery 144 configured to power any electrical component of the handle assembly 100, and a plurality of motors (i.e., a first motor 152a, a second motor 152b, and a third motor 152c) connected to the battery 144. The electric handle 101 also includes a display 146. In an embodiment, the motors 152a, 152b, and 152c can be connected to any suitable power source (e.g., an AC / DC transformer) configured to provide electrical energy to the motors 152a, 152b, and 152c. Each of the motors 152a, 152b, and 152c is connected to a motor controller 143, which controls the operation of the corresponding motor 152a, 152b, and 152c, including the flow of electrical energy from the battery 144 to the motors 152a, 152b, and 152c. A main controller 147 is provided, which controls the electric handle 101. The main controller 147 is configured to execute software instructions embodying the algorithms disclosed herein, such as a clamping algorithm, a stapling algorithm, and a cutting algorithm that control the operation of the power handle 101 .

[0033] The motor controller 143 includes a plurality of sensors 408a, ..., 408n, which are configured to measure the operating state of the motors 152a, 152b, 152c and the battery 144. The sensors 408a-n include a strain gauge 408b, and may also include a voltage sensor, a current sensor, a temperature sensor, a telemetry sensor, an optical sensor, and a combination thereof. The sensors 408a-408n may measure the voltage, current, and other electrical characteristics of the electrical energy supplied by the battery 144. The sensors 408a-408n may also measure the angular velocity (e.g., rotation speed) in revolutions per minute (RPM), torque, temperature, current consumption, and other operating characteristics of the motors 152a, 152b, 152c. The sensor 408a also includes an encoder configured to count the number of revolutions or other indicators of the motors 152a, 152b, 152c, which the main controller 147 then uses to calculate the linear movement of the components that can be moved by the motors 152a, 152b, 152c. Angular velocity can be determined by measuring the rotation of the motors 152a, 152b, 152c or the drive shaft (not shown) connected to these motors and can be rotated by the motors 152a, 152b, 152c. The positions of the various axially movable drive shafts can also be determined by using various linear sensors disposed in or near the shafts, or extrapolated from RPM measurements. In an embodiment, torque can be calculated based on the adjusted current consumption of the motors 152a, 152b, 152c at a constant RPM. In other embodiments, the motor controller 143 and / or the main controller 147 can measure time and process the above values ​​as a function of time (including integration and / or differentiation), for example, to determine the rate of change of the measured values. The main controller 147 is also configured to determine the distance traveled by the various components of the adapter assembly 200 and / or the end effector 300 by counting the number of revolutions of the motors 152a, 152b, 152c.

[0034] The motor controller 143 is coupled to a main controller 147, which includes a plurality of inputs and outputs for interacting 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 the motors 152a, 152b, 152c and the battery 144, and in turn outputs control signals to the motor controller 143 to control the operation of the motors 152a, 152b, 152c based on the sensor readings and specific algorithmic instructions. The main controller 147 is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc.) coupled to the main controller 147.

[0035] The main controller 147 is also coupled to a storage device 141, which may include a volatile storage device (e.g., RAM) and a non-volatile storage device 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, which are used during operation of the power handle 101.

[0036] The electric handle 101 includes a plurality of motors 152a, 152b, 152c, each of which includes a respective motor shaft (not explicitly shown) extending therefrom and configured to drive a respective transmission assembly. The rotation of the motor shaft caused by the respective motor serves to drive the shaft and / or gear components of the adapter assembly 200 so as to perform various operations of the handle assembly 100. In particular, the motors 152a, 152b, 152c of the electric handle 101 are configured to drive the shaft and / or gear components of the adapter assembly 200 so as to selectively cause the trocar member 274 ( Figure 4 Extension / retraction of trocar member 274 opens / closes end effector 300 (when anvil assembly 500 is connected to trocar member 274 of trocar assembly 270), fires annular array of staples 423 of reload 400, and moves annular knife 444 of reload 400.

[0037] Now go to Figure 3 and Figure 4 , the adapter assembly 200 includes an outer knob housing 202 and an outer tube 206 extending from a distal end of the knob housing 202. The knob housing 202 and the outer tube 206 are configured and sized to accommodate the components of the adapter assembly 200. The knob housing 202 includes an electrical connector 312 and a storage device 310 coupled to the electrical connector. The storage device 310 is configured to store various operating parameters related to the adapter assembly 200. The adapter assembly 200 is configured to convert a rotation of a coupling shaft (not explicitly shown) of the handle assembly 100 into an axial translation that can be used to operate the trocar assembly 270, the anvil assembly 500, and / or the staple driver 430 or knife assembly 440 of the reloader 400 of the adapter assembly 200.

[0038] Adapter assembly 200 further includes a trocar assembly 270 removably supported in the distal end of outer tube 206. Trocar assembly 270 includes a trocar member 274 and a drive screw 276 operably received within trocar member 274 for axially moving trocar member 274 relative to outer tube 206. Distal end 274b of trocar member 274 is configured to selectively engage anvil assembly 500 such that axial movement of trocar member 274 achieved by rotation of drive screw 276 causes concomitant axial movement of anvil assembly 500.

[0039] refer to Figure 4 , the clamp transmission assembly 240 includes: a first rotatable proximal drive shaft 212 coupled to the first motor 152a, 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 plays the following roles: extending / retracting the trocar member 274 of the trocar assembly 270 of the adapter assembly 200; and opening / closing the anvil assembly 500 when the anvil assembly 500 is connected to the trocar member 274.

[0040] refer to Figure 5 , the adapter assembly 200 includes a suturing drive assembly 250 for interconnecting the second motor 152b and the second axially translatable drive member of the reloader 400, wherein the suturing drive assembly 250 converts and transmits the rotation of the second motor 152b into an axial translation of the external flexible belt assembly 255 of the adapter assembly 200 and further converts and transmits it into an axial translation of the nail driver 430 of the reloader 400, so as to fire the nail 423 from the reloader 400 and abut against the anvil assembly 500.

[0041] The suture drive assembly 250 of the adapter assembly 200 includes an external flexible belt assembly 255, which is fixed to the nail driver coupler 254. The second rotatable proximal drive shaft 220 is connected to the second motor 152b and is configured to actuate the nail driver coupler 254, which converts the rotational movement into the longitudinal movement. The external flexible belt assembly 255 includes a first flexible belt 255a and a second flexible belt 255b, which are laterally spaced apart and connected to a support ring 255c at the proximal ends of the first flexible belt and the second flexible belt, and connected to the proximal end of the distal pusher 255d at the distal ends of the first flexible belt and the second flexible belt. Each of the first flexible belt 255a and the second flexible belt 255b is attached to the support ring 255c and the distal pusher 255d. The external flexible belt assembly 255 further includes a first connection extension 255e and a second connection extension 255f extending proximally from the support ring 255c. First connecting extension 255e and second connecting extension 255f are configured to operably connect outer flexible band assembly 255 to staple driver coupler 254 of suture drive assembly 250 .

[0042] refer to Figure 6 The adapter assembly 200 also includes a cutting transmission assembly 260 having a third rotatable proximal drive shaft 222 for interconnecting the third motor 152c and the annular knife 444 of the reloader 400, wherein the cutting transmission assembly 260 converts and transmits the rotation of the third motor 152c into an axial translation of the internal flexible belt assembly 265 of the adapter assembly 200 and further converts and transmits it into an axial translation of the knife holder 442 of the reloader 400 to advance the annular knife 444 from the reloader 400 and abut against the anvil assembly 500.

[0043] The inner flexible band assembly 265 includes a first flexible band 265a and a second flexible band 265b which are laterally spaced apart and connected to a support ring 265c at their proximal ends and to a proximal end of a support base 265d at their distal ends. Each of the first flexible band 265a and the second flexible band 265b is attached to the support ring 265c and the support base 265d.

[0044] The inner flexible band assembly 265 further includes a first connection extension 265e and a second connection extension 265f extending proximally from the support ring 265c. The first connection extension 265e and the second connection extension 265f are configured to operably connect the inner flexible band assembly 265 to the knife drive 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.

[0045] refer 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 to selectively contact and abut with the distal pusher 255d of the outer flexible belt assembly 255 of the suture drive assembly 250 of the adapter assembly 200. In operation, during the distal advancement of the outer flexible belt assembly 255, as described above, the distal pusher 255d of the outer flexible belt assembly 255 contacts the proximal end 432a of the driver adapter 432 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 that are aligned with the staple pockets 421 of the staple cartridge 420 to facilitate contact with the staples 423. Accordingly, the advancement of the driver 434 relative to the staple cartridge 420 causes the staples 423 to be ejected from the staple cartridge 420.

[0046] The knife assembly 440 of the reloader 400 includes a knife bracket 442 and an annular knife 444 fixed around the distal end 442b of the knife bracket 442. The proximal end 442a of the knife bracket 442 is configured to engage with the support base 265d of the internal flexible belt assembly. In operation, during the distal advancement of the internal flexible belt assembly 265, the support base 265d of the internal flexible belt assembly 265 is connected to the proximal end 442a of the knife bracket 442 to advance the knife bracket 442 and the annular knife 444 from a first or proximal position to a second or advanced position, thereby cutting tissue disposed between the staple cartridge 420 and the anvil assembly 500.

[0047] The forces during actuation of the cannula needle assembly 274, closing of the end actuator 300 (e.g., retraction of the anvil assembly 500 relative to the reloader 400), ejection of the staples 423 from the reloader 400, and advancement of the knife assembly 440 can be measured by the strain gauge 408b in order to monitor and control various processes (such as firing the staples 423 from the reloader 400); monitor the forces during the firing and formation of the staples 423 as the staples 423 are being ejected from the reloader 400; optimize the formation of the staples 423 as the staples 423 are being ejected from the reloader 400 (e.g., staple curl height) for different tissue indications; and monitor and control the firing of the annular knife of the reloader 400.

[0048] refer to Figure 8 , the strain gauge 408b of the adapter assembly 200 is disposed within the strain gauge housing 320. The strain gauge 408b measures and monitors the retraction of the cannula needle member 274 and the ejection and formation of the nail 423 from the reload 400. During the closing of the end effector 300, when the anvil assembly 500 contacts tissue, obstacles, tissue contact surfaces of the reload 400, nails are ejected, etc., a reaction force is applied to the anvil assembly 500, which is generally in the distal direction. The reaction force directed distally is transmitted from the anvil assembly 500 to the strain gauge 408b. The strain gauge 408b then transmits a signal to the main controller circuit board 142 of the electric handle 101 of the handle assembly 100. A graphic is then displayed on the display screen 146 of the handle assembly 100 to provide the user with real-time information related to the firing status of the handle assembly 100.

[0049] Trocar assembly 270 is axially and rotationally fixed within outer tube 206 of adapter assembly 200. Figure 8 , the adapter assembly 200 includes a support block 292 that is 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.

[0050] In operation, the strain gauge 408b of the adapter assembly 200 measures and monitors the retraction of the trocar member 274, which passes through the strain gauge 408b. Since the first flexible band 255a and the second flexible band 255b also pass through the strain gauge 408b, the strain gauge 408b of the adapter assembly 200 also measures and monitors the ejection of the staples 423 from the reload 400. During clamping, stapling and cutting, a reaction force is exerted on the anvil assembly 500 and the reload 400, which is transmitted to the support block 292, which then transmits the reaction force to the strain sensor of the strain gauge 408b.

[0051] The strain sensor of strain gauge 408b may be any device configured to measure strain (a dimensionless quantity) on an object to which it is attached (e.g., support block 292) such that when the object deforms, the metal foil of the strain sensor also deforms causing a change in its resistance which is then used to calculate the load experienced by trocar assembly 270. Strain gauge 408b provides closed loop feedback to the firing / clamping load presented by the first, second, and third force / rotation transmitting / converting assemblies.

[0052] The strain sensor of the strain gauge 408b then transmits the signal to the main controller circuit board 142. The graphics are then displayed on the display 146 of the handle assembly 100 to provide the user with real-time information related to the firing status of the handle assembly 100. The strain gauge 408b is also electrically connected to the electrical connector 312 ( Figure 3 ).

[0053] For further details about the construction and operation of the circular stapler and its components, reference may be made to International Application Publication No. PCT / US2019 / 040440, filed on July 3, 2019, the entire contents of which are incorporated herein by reference.

[0054] Reload 400 includes storage device 402, and circular adapter assembly 200 also includes storage device 310 ( Figure 4 ). Storage devices 402 and 310 include non-volatile storage media (e.g., EEPROM) configured to store any data related to reload 400 and circular adapter assembly 200, respectively, including, but not limited to, usage counts, identification information, model numbers, serial numbers, nail sizes, stroke lengths, maximum actuation forces, minimum actuation forces, factory calibration data, etc. In an embodiment, the data may be encrypted and can only be decrypted by a device (e.g., master controller 147) with the appropriate key. The data may also be used by master controller 147 to authenticate circular adapter assembly 200 and / or reload 400. Storage devices 402 and 310 may be configured in a read-only mode or a read / write mode, allowing master controller 147 to read data from and write data to storage devices 402 and 310.

[0055] Before the electric circular stapler 10 is operated, the electric handle 101 is enclosed in the housing 11, and the adapter assembly 200 is coupled to the handle assembly 100. After the circular adapter assembly 200 is attached, the handle assembly 100 first verifies that the circular adapter assembly 200 is coupled to the handle assembly by establishing communication with the storage devices 310 and 402, and authenticates the reload circular adapter assembly 200 and the reload 400. The data (e.g., usage count) stored on the storage devices 310 and 402 is encrypted and authenticated by the electric handle 101, and then it is determined whether the usage count stored on the storage devices 310 and 402 exceeds a threshold value (e.g., if the adapter assembly 200 has been previously used). Then, the electric handle 101 performs a verification check (e.g., end-of-life check, missing trocar member 274, etc.), and calibrates the circular adapter assembly 200 after the handle assembly 100 confirms that the trocar member 274 has been attached.

[0056] The user begins the surgical procedure by positioning the adapter assembly 200 (including the trocar member 274 and the anvil assembly 500) in the colorectal or upper gastrointestinal region. The user depresses the toggle control button 30 to extend the trocar member 274 until the trocar member pierces the tissue. After extending the trocar member 274, the anvil assembly 500 previously positioned by the surgeon is attached to the trocar member 274, and the user begins the process of clamping the tissue interposed between the reload 400 and the anvil assembly 500 by depressing the bottom portion of the toggle control button 30.

[0057] refer to Fig.9A and Fig. 9B , a method for determining low tissue compression includes: at step 600, receiving data related to the reloader 400 from the storage device 141 of the stapler 10 or any other storage device at the electric handle 101. The data may include the size of the reloader 400, representing a diameter from about 20 mm to about 35 mm. The diameter of the reloader 400 depends on the size (diameter) of the colon, intestine, etc. being engaged, which is determined by the surgeon. The data may also include a clamping distance, which represents the distance that the anvil 500 moves during the clamping phase in order to clamp the tissue. The clamping distance value may include a first clamping distance (ie, a full clamping distance) and a second clamping distance (ie, a minimum clamping distance that provides a larger clamping gap). In addition to the diameter, the data may also include thickness information of the reloader 400, for example, medium / thick (MT), extra thick (XT) suitable for tissues of different thicknesses.

[0058] The data may also include various force limits, such as minimum and maximum clamping force limits, a starting clamping force, a target clamping force, and the like. The starting clamping force may be any suitable threshold, such as from about 10 pounds to about 50 pounds. In an embodiment, the target clamping force may be about 150 pounds. The minimum clamping force may be about 10 pounds and the maximum clamping force may be about 250 pounds. In an embodiment, the master controller 147 may calculate the minimum clamping force limit based on the size of the reloader 400. More specifically, the master controller 147 may store a tissue pressure lower limit and may calculate the minimum clamping force limit by multiplying the tissue pressure lower limit by the surface area. The tissue pressure lower limit may be empirically derived from anastomotic tissue testing.

[0059] After the anvil assembly 500 (placed in place by the surgeon) is attached to the trocar member 274, the user begins the clamping process of the tissue interposed between the reload 400 and the anvil assembly 500 by pressing the bottom of the toggle control button 30 at step 602. During clamping, the anvil assembly 500 is retracted toward the reload 400 until a preset full clamp position is reached, i.e., a position of the anvil assembly 500 at which the tissue is fully clamped between the anvil assembly 500 and the reload 400. This position is continuously monitored at step 604. The preset full clamp position varies for each different type of reload (e.g., for MT reloads, the distance is about 0.61 mm, for XT reloads, the distance is about 0.94 mm), and is based on the clamping distance read from the memory device 141. When clamping, the strain gauge 408b continuously provides the main controller 147 with measurements of the forces exerted on the trocar member 274 as it moves the anvil assembly 500 to clamp tissue between the anvil assembly 500 and the reload 400. In addition, the clamp time (i.e., the time to reach the fully clamped position) and the clamp pressure are also monitored as safety checks.

[0060] Once anvil assembly 500 reaches the fully clamped position, at step 606, master controller 147 compares the final clamping force (i.e., the clamping force measured when the fully clamped position is reached) to the minimum clamping force limit to determine whether sufficient tissue is disposed and compressed between anvil assembly 500 and reload 400. If the final clamping force is above the minimum clamping force limit (i.e., the minimum clamping force limit calculated by master controller 147 or read from memory device 141), this indicates that sufficient tissue is present between anvil assembly 500 and reload 400 to proceed with the stapling and cutting phases of the process at step 608.

[0061] If the final clamping force is less than the minimum clamping force limit, this indicates that insufficient tissue exists between the anvil assembly 500 and the reload 400. At step 610, the controller 147 continues the clamping process during which the anvil assembly 500 continues to retract toward the reload 400 toward the minimum clamping gap. During this stage, at step 612, the controller 147 compares the clamping force to the minimum clamping force limit continuously or at a predetermined sampling rate (e.g., 5 Hz). If the measured clamping force is still not equal to (i.e., has not yet reached) the minimum clamping force, then at step 614, the controller 147 additionally determines whether the measured clamping gap (i.e., the distance between the anvil assembly 500 and the reload 400) has reached the minimum clamping gap. If the minimum clamping distance has not yet been reached, the controller 147 returns to step 610 to continue the clamping process.

[0062] Returning to step 614, if the clamp gap is equal to (i.e., has reached) the minimum clamp gap and the clamp force is not equal to (i.e., has not yet reached) the minimum clamp force, the controller 147 outputs a clamp alarm at step 616. The alarm may be a prompt displayed on the display screen 146 indicating that tissue compression is too low and / or the anvil assembly 500 is disengaged.

[0063] At step 618, in addition to the clamping alarm, the controller 147 prohibits the subsequent stages, namely ejecting staples and cutting. The only remaining action available is retraction to allow the user to retry the process by releasing and withdrawing the stapler 10.

[0064] Returning to step 612, if the measured clamping force is equal to the minimum clamping force, then at step 620, the controller 147 stops the clamping process and outputs another alarm on the display screen 146 indicating that the tissue pressure is too low, possibly due to insufficient tissue. The surgeon or assistant can verify the cause of the low pressure. At step 622, the controller 147 can also output another prompt, i.e., recommending to inspect the tissue, evaluate the selection of the reload 400, or recommend suture. In particular, if the XT reload 400 is initially used and the tissue pressure is detected to be too low, the user can select and / or the controller 147 can recommend the MT reload 400.

[0065] After the prompt, the user can choose to staple at step 624 (e.g., if no suitable replacement reload 400 is available), or to release at step 626, for example, to try another reload 400. The selection can be made via the toggle control button 30, for example, pressing down to enter step 624 for stapling and cutting and pressing up to release clamping at step 626. At step 624, the controller 147 operates the stapler 10 in a "reduced clamp gap" condition and then automatically adjusts the stapling stroke and the cutting stroke to compensate for the more proximal position of the anvil to ensure that good staple formation and anastomotic cutting are achieved in this reduced gap state, which is less than the normal clamp gap of the fully clamped position.

[0066] It should be understood that various modifications may be made to the embodiments of the adapter assembly disclosed herein. Therefore, the above description should not be construed as restrictive, but merely as an example of an embodiment. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

[0067] In one or more examples, the described techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can 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 a non-transitory computer-readable medium, which corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store the desired program code in the form of instructions or data structures and can be accessed by a computer).

[0068] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Accordingly, the term "processor" as used herein may refer to any of the above structures or any other physical structures suitable for implementing the described techniques. In addition, these techniques may be fully implemented in one or more circuits or logic elements.

Claims

1. A surgical device, comprising: a reload assembly, the reload assembly comprising a plurality of staples; an anvil assembly movable relative to the reload assembly; power supply; a motor coupled to the power source; a transmission assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly; a force sensor configured to measure a force applied by the transmission assembly to the anvil assembly; a storage device storing data including a minimum clamping force limit; as well as A controller, the controller being configured to: activating the motor to move the anvil assembly relative to the reload assembly; comparing the measured force to the minimum clamping force limit; and An alarm is output in response to the measured force being below the minimum clamping force limit.

2. The surgical device according to claim 1, wherein: The data further includes a clamping distance.

3. The surgical device according to claim 2, wherein: The controller is further configured to activate the motor to move the anvil assembly relative to the reload assembly until the clamping distance is reached.

4. The surgical device according to claim 3, wherein: The controller is further configured to compare the force measured at the clamping distance to the minimum clamping force limit.

5. The surgical device according to claim 1, wherein: The controller is further configured to enable ejection of the plurality of staples in response to the measured force being above the minimum clamping force limit.

6. The surgical device according to claim 1, wherein: The controller is further configured to determine an alternate reload assembly in response to the measured force being below the minimum grip force limit.

7. The surgical device according to claim 6, further comprising: A display screen is configured to display at least one of the alert or information related to the replacement reload.

8. A method for controlling a surgical device, the method comprising: receiving, at a controller, a minimum clamping force limit stored in a storage device; activating a motor to move a drive assembly coupled to an anvil assembly movable relative to a reload assembly having a plurality of staples; measuring the force applied by the transmission assembly to the anvil assembly by a force sensor; comparing, at the controller, the measured force to the minimum clamping force limit; as well as An alarm is output by the controller in response to the measured force being below the minimum clamping force limit.

9. The method according to claim 8, further comprising: A grip distance stored in a storage device of the reload is received at the controller.

10. The method according to claim 9, further comprising: The motor is activated to move the anvil assembly relative to the reload assembly until the clamping distance is reached.

11. The method according to claim 10, further comprising: At the controller, the force measured at the clamping distance is compared to the minimum clamping force limit.

12. The method according to claim 8, further comprising: In response to the measured force being above the minimum clamping force limit, ejection of the plurality of staples is enabled.

13. The method according to claim 9, further comprising: An alternate reload assembly is determined at the controller in response to the measured force being below the minimum clamping force limit.

14. The method according to claim 13, further comprising: In response to the measured force at the clamping distance being less than the minimum clamping force, a determination is made at the controller to further retract the anvil until the minimum clamping force is reached, and then an alarm is issued for a low tissue compression condition, and the option is provided to continue to eject the plurality of staples, in which case the controller reduces the stapling and cutting strokes to compensate for the more proximal position of the anvil.

15. A surgical device comprising: a reload assembly including a plurality of staples and a storage device storing data related to the reload assembly, the data including a minimum clamping force limit and a clamping distance; an anvil assembly movable relative to the reload assembly; power supply; a motor coupled to the power source; a transmission assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly; a force sensor configured to measure a force applied by the transmission assembly to the anvil assembly; monitor; as well as A controller, the controller being configured to: activating the motor to move the anvil assembly relative to the reload assembly until the clamping distance is reached; comparing the force measured at the clamping distance to the minimum clamping force limit; and An alarm is output on the display in response to the measured force being below the minimum clamping force limit.

16. The surgical device according to claim 15, wherein: The controller is further configured to determine an alternate reload assembly thickness indicator based on the measured force.

17. The surgical device according to claim 16, wherein: The controller is further configured to output information on the display related to the alternate reload assembly thickness indication.

18. The surgical device according to claim 15, wherein: The controller is further configured to enable ejection of the plurality of staples in response to the measured force being above the minimum clamping force limit.

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