Handheld electromechanical surgical system with low tissue compression indication

Abstract

The surgical device includes a reload assembly having a plurality of staples and a memory device that stores data including a minimum clamping force limit value. The surgical device also includes an anvil assembly movable relative to the reload assembly, a power source, and a motor coupled to the power source. The surgical device further includes a transmission assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly. The surgical device also includes a force sensor configured to measure the force applied to the anvil assembly by the transmission assembly. The surgical device also includes a controller configured to activate the motor to move the anvil assembly relative to the reload assembly, compare the measured force to the minimum clamping force limit value, and output an alert in response to the measured force being lower than the minimum clamping force limit value.

Description

Technical Field

[0001] Cross - Reference to Related Applications 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 above - mentioned application is hereby incorporated by reference into this specification.

[0002] This disclosure relates to surgical devices. More specifically, this disclosure relates to a hand - held electromechanical surgical system for performing surgical procedures.

Background Art

[0003] Circular staplers are used in surgical procedures to re - attach a previously excised portion of the rectum or in similar procedures. The circular clamping, cutting, and stapling 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 at the distal end of the elongated shaft. A physician can insert the anvil assembly of the circular stapling instrument toward the portion of the rectum excised from the incision. Also, the physician can insert the remaining portion of the circular stapling instrument (including the cartridge assembly) into the patient's rectum and manipulate the instrument above the patient's large intestine tube and toward the excised portion of the rectum. The anvil and the cartridge assembly move closer to each other, staples are discharged from the cartridge assembly toward the anvil assembly, staples are formed in the tissue, end - to - end anastomosis is performed, and a circular knife advances to take a core of a portion of the clamped tissue. After end - to - end anastomosis is performed, the circular stapling instrument is removed from the surgical site. Also, powered surgical staplers that use one or more motors to clamp, cut, and staple tissue have been developed. Due to variations in the patient's anatomical structure, the thickness of the tissue to be stapled varies considerably. Therefore, it is necessary to measure the thickness of the tissue during the stapling procedure.

Summary of the Invention

Means for Solving the Problems

[0004] The present disclosure provides a powered circular stapler configured to operate in four sequences, namely, clamp, staple, cut, and unclamp, to form an anastomosis by connecting two portions of a structure (e.g., intestine, colon, etc.). The powered circular stapler includes a handle assembly having a power source and one or more motors coupled to the power source. The stapler also includes a plurality of transmission assemblies, such as an adapter assembly having a drive shaft, for transmitting actuation from the powered handle. The powered handle assembly and the adapter assembly may be reusable.

[0005] The powered surgical stapler operates in four stages, namely, clamp, staple, cut, and unclamp. Clamping is achieved by moving the anvil in the proximal direction to compress tissue between the anvil and a reload assembly that includes a plurality of staples. The anvil and the reload assembly may be disposable. During stapling, the staples are ejected from the reload assembly into the clamped tissue and deformed against the anvil. Cutting includes moving a circular knife through the compressed and stapled tissue until the knife contacts the anvil. During unclamping, the anvil assembly is moved distally from the cut tissue and the reload assembly.

[0006] Each of the steps of clamping, stapling, cutting, and clamp release may be monitored to ensure proper operation of the powered surgical stapler, including proper anvil release after the cutting process is complete. The powered surgical stapler includes a sensor configured to measure the force during each process, such as a strain gauge, and a controller configured to monitor the force during operation of the powered surgical stapler and detect anomalies. The powered stapler is configured to operate with a plurality of different sized reloads having a diameter of from about 20 mm to about 35 mm and having an anvil of a corresponding size. The minimum clamp force may be stored in device software present on the handle or any other suitable location such as a cloud service. In embodiments, each of the reloads may include a storage device storing various parameters including a minimum clamp force limit value.

[0007] This powered surgical stapler is configured to monitor the clamp force during surgery and determine the thickness of the tissue compressed between the anvil and the reload. Thereby, the user can select a more appropriate end effector, for example a smaller one, which conforms to the indication of a thinner thickness and ensures better results and a reduced likelihood of leakage. Accordingly, the present disclosure provides a method of determining whether the tissue compression pressure is lower than that recommended for the selected end effector and communicating that information to the surgeon prior to firing. Thereby, the surgeon can make a more informed decision based on the immediate feedback from the device.

[0008] This method involves establishing a minimum clamping force limit value for each size of end effector such that an equivalent "low pressure limit value" is the same for end effectors of all sizes, since 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 each different end effector, different "minimum clamping force limit values" are established for each end effector so that the "low tissue pressure limit value" is the same for all sizes. Thus, when clamping a specified tissue gap with a particular end effector, if the final clamping force at the specified tissue gap falls below the minimum clamping force limit value, the powered surgical stapler may display or provide to the user some other indication that the tissue pressure may be too low, and it is necessary to warn that it may be necessary to evaluate the situation and decide whether to fire, reduce the size, or form an anastomosis in some other way (e.g., suturing, etc.) after obtaining information.

[0009] According to one embodiment of the present disclosure, a surgical device is disclosed. The surgical device includes a reload assembly having a plurality of staples. The surgical device also includes an anvil assembly movable relative to the reload assembly, a power source, and a motor coupled to the power source. The surgical device further includes a transmission assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly. The surgical device also includes a force sensor configured to measure the force applied to the anvil assembly by the transmission assembly, and a memory device storing data including a minimum clamping force limit value. The surgical device also includes a controller configured to activate the motor to move the anvil assembly relative to the reload assembly, compare the measured force with the minimum clamping force limit value, and output an alert in response to the measured force being lower than the minimum clamping force limit value.

[0010] The embodiments of the above-described embodiments may include one or more of the following features. According to one aspect of the above-described embodiments, the data may further include a clamp distance. The controller may be further configured to operate the motor to move the anvil assembly relative to the reload assembly until the clamp distance is reached. The controller may also be configured to compare the force measured at the clamp distance with a minimum clamp force limit value. The controller may be further configured to enable the ejection of a plurality of staples in response to the measured force being higher than the minimum clamp force limit value. The controller may also be configured to determine an alternative reload assembly in response to the measured force being lower than the minimum clamp force limit value. The surgical device may also include a display screen configured to display at least one of an alert or information regarding the alternative reload.

[0011] According to another embodiment of the present disclosure, a method of controlling a surgical device is disclosed. The method includes receiving, at a controller, a minimum clamp force limit value stored in a memory device. The method also includes operating a motor to move a transmission assembly coupled to an anvil assembly movable relative to a reload assembly having a plurality of staples. The method further includes measuring, via a force sensor, a force applied to the anvil assembly by the transmission assembly. The method also includes comparing, at the controller, the measured force with the minimum clamp force limit value. The method further includes outputting, by the controller, an alert in response to the measured force being lower than the minimum clamp force limit value.

[0012] The embodiments of the above-described embodiments may include one or more of the following features. According to one aspect of the above-described embodiments, the method may further include, in a controller, receiving a clamp distance stored in a reload storage device. Further, the method may include operating a motor to move an anvil assembly relative to a reload assembly until the clamp distance is reached. The method may further include, in a controller, comparing a force measured at the clamp distance with a minimum clamp force limit value. The method may further include enabling ejection of a plurality of staples in response to the measured force being higher than the minimum clamp force limit value. The method may also include, in a controller, determining an alternative reload assembly in response to the measured force being lower than the minimum clamp force limit value. The method may further include outputting at least one of an alert or information regarding the alternative reload to a display screen.

[0013] According to a further embodiment of the present disclosure, a surgical device is disclosed. The surgical device includes a reload assembly having a plurality of staples and a storage device storing data regarding the reload assembly. The data includes a minimum clamp force limit value and a clamp distance. The device also includes an anvil assembly movable relative to the reload assembly. The device further includes a power source and a motor coupled to the power source. The device further includes a transmission assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly. The device further includes a force sensor configured to measure a force applied to the anvil assembly by the transmission assembly. The device further includes a display and a controller configured to: operate the motor to move the anvil assembly relative to the reload assembly until the clamp distance is reached; compare a force measured at the clamp distance with the minimum clamp force limit value; and output an alert to the display in response to the measured force being lower than the minimum clamp force limit value.

[0014] The embodiments of the above-described embodiments may include one or more of the following features.

[0015] In another embodiment, if the clamping force falls below the minimum clamping force limit when the anvil reaches the normal clamping distance, the stapler may continue to move the anvil proximally toward the reload so as to be below the normal clamping distance and stop clamping when the minimum clamping force is achieved. At this point, the stapler may need to display or provide some other indication to the user that they need to evaluate the situation and make a decision about whether to fire, reduce the size, or form an anastomosis in some other way (e.g., suturing, etc.) based on the information obtained. If firing is selected with this reduced clamp gap, the device adjusts the staple and cutting strokes to compensate for the more proximal position of the anvil to ensure good staple formation and cutting of the anastomosis in this reduced gap state (smaller than the normal clamp gap).

[0016] Embodiments of the present disclosure are described herein with reference to the accompanying drawings.

Brief Description of the Drawings

[0017]

Figure 1

Figure 2

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Figure 8

Figure 9A

Figure 9B

[0018] Embodiments of the surgical devices, and adapter assemblies and / or handle assemblies for surgical devices, disclosed herein are described in detail with reference to the drawings, in which like reference numerals refer to the same or corresponding elements in each of several figures. As used herein, the term "distal" refers to the portion of a surgical instrument or component thereof that is farther from the user, while the term "proximal" refers to the portion of a surgical instrument or component thereof that is closer to the user.

[0019] The present disclosure provides a powered 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 enables complete, independent control of four functions, namely clamp, staple, cut, and unclamp. This allows adaptation of specific portions of the stapler in cases where the tissue presents non-ideal situations.

[0020] FIG. 1 shows a surgical device, such as a powered circular stapler 10 for forming, for example, an end-to-end anastomosis (EEA), which includes 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 effect a surgical result on a patient's tissue by clamping, stapling, and cutting tissue held within the end effector 300, i.e., forming an anastomosis by connecting two portions of a structure (e.g., intestine, colon, etc.).

[0021] 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 pivotally connected to the distal half 11a. When joined, the distal and proximal halves 11a, 11b define a shell cavity within which the power handle 101 is disposed.

[0022] The powered circular stapler 10 is described herein as a modular device that includes a plurality of interconnected components, such as the handle assembly 100, the removable shell housing 11, and the adapter assembly 200, among others. However, the powered circular stapler 10 may be formed as an integral device in which one or more of the components are fixedly attached to each other, for example, during the manufacture of the powered circular stapler.

[0023] The distal and proximal halves 11a, 11b of the shell housing 11 are divided along a plane that intersects 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 a corresponding drive coupling assembly 210 (FIG. 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).

[0024] Referring to FIGS. 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, a second motor 152b, and a third motor 152c. The power handle 101 also includes a display 146. In an embodiment, the motors 152a, 152b, 152c can be coupled to any suitable power source configured to supply electrical energy to the motors 152a, 152b, 152c, such as an AC / DC transformer. Each of the motors 152a, 152b, 152c is coupled to a motor controller 143 that controls the operation of the corresponding motor 152a, 152b, 152c, including the flow of electrical energy from the battery 144 to the motors 152a, 152b, 152c. A main controller 147 for controlling the power handle 101 is provided. The main controller 147 is configured to execute software instructions that implement algorithms disclosed herein, such as clamp, staple, and cut algorithms, to control the operation of the power handle 101.

[0025] The motor controller 143 includes a plurality of sensors 408a...408n configured to measure the operating states of motors 152a, 152b, 152c and battery 144. Sensors 408a~n include strain gauges 408b and may also 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, 152b, 152c. Sensor 408a also includes an encoder configured to count the rotation or other indicators of motors 152a, 152b, 152c, which is then used by main controller 147 to calculate the linear movement of the components movable by motors 152a, 152b, 152c. The angular velocity may be determined by measuring the rotation of motors 152a, 152b, 152c or a drive shaft (not shown) coupled to motors 152a, 152b, 152c and rotatable by motors 152a, 152b, 152c. The position of the drive shaft movable in various axial directions may also be determined by using various linear sensors disposed on or proximate to the shaft, or may be estimated from the RPM measurements. In an embodiment, the torque may be calculated based on the regulated current draw of motors 152a, 152b, 152c at a constant RPM. In a further embodiment, motor controller 143 and / or main controller 147 may measure time, for example, to determine the rate of change of the measured values, and process the values described above, including integration and / or differentiation, in accordance with time. Main controller 147 is also configured to determine the travel distance of the various components of adapter assembly 200 and / or end effector 300 by counting the rotation of motors 152a, 152b, 152c.

[0026] The motor controller 143 is coupled to the main controller 147, and the main controller 147 includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 147 receives measured sensor signals regarding the operating states of the motors 152a, 152b, 152c from the motor controller 143, and the battery 144, 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 algorithm instructions. The main controller 147 is also configured to receive a plurality of user inputs, for example, from a user interface (such as switches, buttons, touchscreens, etc.) coupled to the main controller 147.

[0027] The main controller 147 is also coupled to the memory device 141. The memory device 141 may include volatile (e.g., RAM) and non-volatile memory 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.

[0028] The power handle 101 includes a plurality of motors 152a, 152b, 152c, each including a respective motor shaft (not explicitly shown) that extends therefrom and is configured to drive a respective 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, 152b, 152c 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 of the trocar assembly 270 of the adapter assembly 200 (Figure 4). The extension / retraction of the trocar member 274 opens and closes the end effector 300, fires the annular array of staples 423 of the reload 400, and moves the annular knife 444 of the reload 400 (when the anvil assembly 500 is connected to the trocar member 274 of the trocar assembly 270).

[0029] Referring now to FIGS. 3 and 4, the adapter assembly 200 includes an outer knob housing 202 and an outer tube 206 that extends from the tip of the knob housing 202. The knob housing 202 and the outer tube 206 are configured and dimensioned to house 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 related to the adapter assembly 200. The adapter assembly 200 is configured to convert the rotation of a coupling shaft (not explicitly shown) of the handle assembly 100 into an axial translational movement 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.

[0030] The adapter assembly 200 further includes a trocar assembly 270 removably supported at the tip of the outer tube 206. The trocar assembly 270 includes a trocar member 274 and a driving screw 276 operably received within the trocar member 274 for axially moving the trocar member 274 relative to the outer tube 206. The tip 274b of the trocar member 274 is configured to selectively engage the anvil assembly 500 such that axial movement of the trocar member 274 results in an associated axial movement of the anvil assembly 500 via rotation of the driving screw 276.

[0031] Referring to FIG. 4, the tightening 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 tightening 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 500 when the anvil assembly 500 is connected to the trocar member 274.

[0032] Referring to FIG. 5, the adapter assembly 200 includes a stitching transmission assembly 250 for interconnecting the second motor 152b and the second axially translatable driver member of the reload 400. The stitching transmission assembly 250 converts and transmits the rotation of the second motor 152b into axial translation of the outer flexible band assembly 255 of the adapter assembly 200 and thence to the staple driver 430 of the reload 400 to fire staples 423 from the reload 400 and against the anvil assembly 500.

[0033] The suture transmission assembly 250 of the adapter assembly 200 includes an outer flexible band assembly 255 fixed to the stapler driver coupler 254. The second rotatable proximal drive shaft 220 is coupled to the second motor 152b and is configured to operate the stapler driver coupler 254, which converts rotational movement into longitudinal movement. The outer flexible band assembly 255 includes first and second flexible bands 255a, 255b that are laterally spaced apart and are connected at their proximal ends to the support ring 255c and at their distal ends to the proximal end of the 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 connection extensions 255e, 255f that extend proximally from the support ring 255c. The first and second connection extensions 255e, 255f are configured to operably connect the outer flexible band assembly 255 to the stapler driver coupler 254 of the suture transmission assembly 250.

[0034] Referring to FIG. 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 reload 400. The cutting transmission assembly 260 converts and transmits one rotation of the third motor 152c into axial movement of the inner flexible band assembly 265 of the adapter assembly 200 and thus of the knife carrier 442 of the reload 400, advancing the annular knife 444 from the reload 400 towards the anvil assembly 500.

[0035] The inner flexible band assembly 265 includes first and second flexible bands 265a, 265b that are laterally spaced apart and are 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, 265b is attached to the support ring 265c and the support base 265d.

[0036] The inner flexible band assembly 265 further includes first and second connection extensions 265e, 265f that extend proximally from the support ring 265c. The first and second connection extensions 265e, 265f are configured to operably connect the inner 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.

[0037] Referring to FIG. 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 tip pusher 255d of the outer flexible band assembly 255 of the suture transmission assembly 250 of the adapter assembly 200. During operation, as described above, during forward movement of the outer flexible band assembly 255 to the tip side, the tip pusher 255d of the outer flexible band assembly 255 contacts the proximal end 432a of the driver adapter 432, advancing the driver adapter 432 and the driver 434 from the first or proximal position to the second or distal position. The driver 434 is a plurality of driver members 436, including a plurality of driver members 436 aligned with the staple pockets 421 of the staple cartridge 420 for contact with the staples 423. Correspondingly, the advancement of the driver 434 relative to the staple cartridge 420 causes the staples 423 to be removed from the staple cartridge 420.

[0038] 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 a support base 265d of the inner flexible band assembly. During operation, during the distal advancement of the inner flexible band assembly 265, the support base 265d of the inner flexible band assembly 265 connects with the proximal end 442a of the knife carrier 442 to advance the knife carrier 442 and the annular knife 444 from a first position or a proximal position to a second position or an advanced position, causing the cutting of tissue disposed between the staple cartridge 420 and the anvil assembly 500.

[0039] During the actuation of the trocar member 274, during the closure of the end effector 300 (e.g., the housing of the anvil assembly 500 relative to the reload 400), during the ejection of the staples 423 from the reload 400, and during the advancement of the knife assembly 440, the forces can be measured by the strain gauge 408b to monitor and control various processes such as the firing of the staples 423 from the reload 400; to monitor the forces during the firing and formation of the staples 423 when the staples 423 are ejected from the reload 400; to optimize the formation (e.g., staple crimp height) of the staples 423 when the staples 423 are ejected from the reload 400 for different conditions of the tissue; and to monitor and control the firing of the annular knife of the reload 400.

[0040] Referring to FIG. 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 storage of the trocar member 274 and the extraction and formation of staples 423 from the reload 400. During the closing of the end effector 300, when the anvil assembly 500 contacts tissue, an obstacle, the tissue contact surface of the reload 400, staple extraction, etc., a reaction force in the generally distal direction is applied to the anvil assembly 500. This reaction force directed towards the distal side is transmitted from the anvil assembly 500 to the strain gauge 408b. The strain gauge 408b then transmits a signal to the circuit board 142 of the power 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.

[0041] The trocar assembly 270 is fixed so as not to move axially and not to rotate within the outer tube 206 of the adapter assembly 200. Referring to FIG. 8, the adapter assembly 2 has a support block 292 disposed therein so as not to move 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.

[0042] During operation, the strain gauge 408b of the adapter assembly 200 measures and monitors the storage of the trocar member 274 passing 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 extraction of staples 423 from the reload 400. During clamping, stapling and cutting, a reaction force is applied to the anvil assembly 500 and the reload 400, which is transmitted to the support block 292, which in turn transmits the reaction force to the strain sensor of the strain gauge 408b.

[0043] The strain sensor of the strain gauge 408b can be any device configured to measure the strain (a dimensionless quantity) of an object (such as the support block 292) to which it is attached, such that when the object deforms, the metal foil of the strain sensor also deforms, changing its electrical resistance, and this change in resistance is then used to calculate the load received by the trocar assembly 270. The strain gauge 408b provides closed-loop feedback to the firing / tightening load presented by the first, second, and third force / rotation transfer / conversion assemblies.

[0044] Next, the strain sensor of the strain gauge 408b transmits a signal to the main controller circuit board 142. Thereafter, a graphic is displayed on the display 146 of the handle assembly 100, providing the user with real-time information related to the firing state of the handle assembly 100. The strain gauge 408b is also electrically connected to the electrical connector 312 (FIG. 3) via the proximal and distal harness assemblies 314, 316.

[0045] For further details regarding the construction and operation of the circular stapler and its components, reference may be made to International Publication No. PCT / US2019 / 040440, filed Jul. 3, 2019, the entire contents of which are incorporated herein by reference.

[0046] Reload 400 includes a memory device 402, and the circular adapter assembly 200 also includes a memory device 310 (FIG. 4). The memory devices 402 and 310 each include a non-volatile memory medium (e.g., EEPROM) configured to store any data related to the reload 400 and the circular adapter assembly 200, including but not limited to the number of uses, identification information, model number, serial number, staple size, stroke length, maximum operating force, minimum operating force, factory calibration data, etc. In an embodiment, the data can be encrypted and decodable only by a device (e.g., the main controller 147) having an appropriate key. The data can also be used by the main controller 147 to authenticate the circular adapter assembly 200 and / or the reload 400. The memory devices 402 and 310 can be configured in a read-only mode or a read / write mode, allowing the main controller 147 to not only read the data but also write data to the memory devices 402 and 310.

[0047] Prior to the operation of the power circular stapler 10, the power handle 101 is enclosed within the shell housing 11, and the adapter assembly 200 is coupled to the handle assembly 100. After the attachment of the circular adapter assembly 200, the handle assembly 100 first confirms that the circular adapter assembly 200 is coupled thereto by establishing communication with the memory devices 310 and 402, and authenticates the reload circular adapter assembly 200 and the reload 400. The data (e.g., the number of uses) stored in the memory devices 310 and 402 is encrypted and authenticated by the power handle 101 before determining whether the number of uses stored in the memory devices 310 and 402 exceeds a threshold value (e.g., whether the adapter assembly 200 has been used previously). Next, after the power handle 101 confirms that the trocar member 274 is attached to the handle assembly 100, a verification check (e.g., a life check, loss of the trocar member 274, etc.) is performed to calibrate the circular adapter assembly 200.

[0048] The user initiates a surgical procedure by positioning an adapter assembly 200, which includes a trocar member 274 and an anvil assembly 500, within the recto-colon or upper gastrointestinal region. The user presses a toggle control button 30 to extend the trocar member 274 until it pierces the tissue. After the extension of the trocar member 274, the anvil assembly 500, which has been pre-positioned by the surgeon, is attached to the trocar member 274, and the user initiates a clamping process on the tissue inserted between the reload 400 and the anvil assembly 500 by pressing the bottom of the toggle control button 30.

[0049] Referring to FIGS. 9A and 9B, a method for determining low tissue compression includes, at step 600, receiving, at a power handle 101, data associated with a reload 400 from a memory device 141 of the stapler 10 or any other memory device. The data may include the size of the reload 400 indicating its diameter of approximately 20 mm to approximately 35 mm. The diameter of the reload 400 depends on the size (diameter) of the colon, intestine, etc. to be joined, which is determined by the surgeon. The data may also include a clamp distance indicating the distance by which the anvil 500 is moved to clamp the tissue during the clamping phase. The value of the clamp distance may include a first clamp distance, i.e., the distance at which complete clamping occurs, and a second clamp distance, i.e., the minimum clamp distance that provides a larger clamp gap. In addition to the diameter, the data may also include thickness information of the reload 400, e.g., medium thickness (MT), extra thick (XT) suitable for different thicknesses of tissue.

[0050] The data may also include various force limit values, such as a minimum clamp force limit value and a maximum clamp force limit value, a starting clamp force, a target clamp force, and others. The starting clamp force can be any suitable threshold value, for example, from about 10 pounds to about 50 pounds. In an embodiment, the target clamp force can be about 150 pounds. The minimum clamp force can be about 10 pounds, and the maximum clamp force can be about 250 pounds. In an embodiment, the main controller 147 can calculate the minimum clamp force limit value based on the size of the reload 400. More specifically, the main controller 147 can store the low tissue pressure limit value and calculate the minimum clamp force limit value by multiplying the low tissue pressure limit value by the surface area. The low tissue pressure limit value may be derived empirically from anastomotic tissue tests.

[0051] After the anvil assembly 500 (which is positioned at a predetermined position by the surgeon) is attached to the trocar member 274, in step 602, when the user presses the bottom of the toggle control button 30, a clamping process is initiated on the tissue intervening between the reload 400 and the anvil assembly 500. During clamping, the anvil assembly 500 is drawn towards the reload 400 until it reaches a preset fully clamped position, i.e., the position where the tissue is fully clamped between the anvil assembly 500 and the reload 400. This position is continuously monitored in step 604. The preset fully clamped position varies for each different type of reload (for example, the distance is about 0.61 mm for an MT reload and about 0.94 mm for an XT reload) and is based on the clamp distance read from the memory device 141. During clamping, the strain gauge 408b continuously provides the main controller 147 with measurements regarding the force applied to the trocar member 274 when moving the anvil assembly 500 to clamp the tissue between the anvil assembly 500 and the reload 400. Further, the clamping time, i.e., the time until the fully clamped position is reached, and the clamping pressure are also monitored as a safety check.

[0052] When the anvil assembly 500 reaches the fully clamped position, at step 606, the main controller 147 compares the final clamping force, i.e., the clamping force measured when the fully clamped position is reached, with the minimum clamping force limit value to determine whether sufficient tissue is disposed and compressed between the anvil assembly 500 and the reload 400. If the final clamping force exceeds the minimum clamping force limit value, i.e., the minimum clamping force limit value calculated by the main controller 147 or read from the memory device 141, this indicates that sufficient tissue exists between the anvil assembly 500 and the reload 400 for proceeding to the stapling and cutting stages of the process at step 608.

[0053] If the final clamping force is below the minimum clamping force limit value, this indicates that the tissue existing between the anvil assembly 500 and the reload 400 is insufficient. At step 610, the controller 147 continues the clamping process, during which the anvil assembly 500 continues to be drawn towards the reload 400 towards the minimum clamping gap. During this stage, continuously, or at a predetermined sampling rate (e.g., 5 Hz), at step 612, the controller 147 compares the clamping force with the minimum clamping force limit value. If the measured clamping force is still not equal to the minimum clamping force (i.e., the minimum clamping force has not been reached), at step 614, the controller 147 also 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 been reached, the controller 147 returns to step 610 to continue the clamping process.

[0054] Return to step 614. If the clamping force is not equal to the minimum clamping force, i.e., has not reached the minimum clamping force, while the clamping gap is equal to the minimum clamping gap, i.e., has reached the minimum clamping gap, the controller 147 outputs a clamping alert at step 616. This alert can be a prompt displayed on the display screen 146 indicating that the compression of the tissue is too low and / or that the anvil assembly 500 has come loose.

[0055] At step 618, in addition to the clamping alert, the controller 147 disables the subsequent steps, i.e., the ejection and cutting of staples. The only remaining operation that is enabled is the draw-in to allow the user to retry the process by releasing the clamp and pulling out the stapler 10.

[0056] Return to step 612. If the measured clamping force is equal to the minimum clamping force, at step 620, the controller 147 stops the clamping process and outputs another alert on the display screen 146 indicating that the tissue pressure is too low, probably due to insufficient tissue. The surgeon or assistant can check the cause of the low pressure. At step 622, the controller 147 can also output another prompt recommending an examination of the tissue, evaluate the selection of the reload 400, or recommend suturing. In particular, if the XT reload 400 was used first and the tissue pressure was detected to be too low, the MT reload 400 can be selected by the user and / or recommended by the controller 147.

[0057] Following the prompt, the user has the option to either continue stapling at step 624 or release the clamp at step 626, for example, if a suitable alternative reload 400 is not available. The selection can be made via the toggle control button 30, for example, by pressing down to proceed with stapling and cutting to step 624 and pressing up for releasing the clamp at step 626. At step 624, the controller 147 operates the stapler 10 in a "clamp gap reduction" state and then automatically adjusts the staple and cut strokes to compensate for the more proximal position of the anvil to ensure good staple formation and cutting of the anastomosis in this reduced gap state, which is smaller than the normal clamp gap in the fully clamped position.

[0058] It is understood that various modifications can be made to the embodiments of the adapter assembly disclosed herein. Accordingly, the above should be construed as illustrative of the embodiments and not as a limitation. Those skilled in the art may envision other modifications within the scope and spirit of the present disclosure.

[0059] In one or more examples, 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 code 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 corresponding 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 desired program code in the form of instructions or data structures and can be accessed by a computer).

[0060] The commands can 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. Correspondingly, the term "processor", as used herein, can refer to any of the foregoing structures or any other physical structure suitable for implementation of the described technology. Also, the technology can be implemented entirely in one or more circuits or logic elements.

Claims

1. A reload assembly including a plurality of staples, An anvil assembly movable relative to the reload assembly, A power source, 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 to the anvil assembly by the transmission assembly, A memory device storing data including a minimum clamp force limit value, A controller, Actuating the motor to move the anvil assembly relative to the reload assembly, Comparing the measured force with the minimum clamp force limit value, Outputting an alert in response to the measured force being lower than the minimum clamp force limit value, A controller configured as such, And a surgical device including the same.

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

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

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

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 higher than the minimum clamp force limit value.

6. The surgical device according to claim 1, wherein the controller is further configured to determine an alternative reload assembly in response to the measured force being lower than the minimum clamp force limit value.

7. A display screen configured to display at least one of the alert or information regarding the alternative reload, The surgical device according to claim 6, further including the same.

8. A method for controlling a surgical device, comprising: Receiving, by a controller, a minimum clamp force limit value stored in a memory device; Actuating a motor to move a transmission assembly coupled to an anvil assembly movable relative to a reload assembly having a plurality of staples; Measuring, via a force sensor, the force applied to the anvil assembly by the transfer assembly; Comparing, in the controller, the measured force with the minimum clamp force limit value; Outputting, by the controller, an alert in response to the measured force being lower than the minimum clamp force limit value A method comprising.

9. Receiving, in the controller, the clamp distance stored in the memory device of the reload; The method according to claim 8, further comprising.

10. Actuating the motor to move the anvil assembly relative to the reload assembly until the clamp distance is reached; The method according to claim 9, further comprising.

11. Comparing, in the controller, the force measured at the clamp distance with the minimum clamp force limit value; The method according to claim 10, further comprising.

12. Enabling the ejection of the plurality of staples in response to the measured force being higher than the minimum clamp force limit value; The method according to claim 8, further comprising.

13. Determining, in the controller, an alternative reload assembly in response to the measured force being lower than the minimum clamp force limit value; The method according to claim 9, further comprising.

14. Determining, in the controller, to further retract the anvil until the minimum clamp force is achieved in response to the force measured at the clamp distance being less than the minimum clamp force, then warning of a low tissue compression state, and further comprising providing an option to proceed with the ejection of the plurality of staples, and in the case of ejection, the controller reducing the staples and the cutting stroke to compensate for a more proximal position of the anvil; The method according to claim 13.

15. A reload assembly including a plurality of staples and a memory device storing data regarding the reload assembly, the data including a minimum clamp force limit value and a clamp distance; An anvil assembly movable relative to the reload assembly; A power source; A motor coupled to the power source; A transfer assembly movable by the motor and configured to move the anvil assembly relative to the reload assembly; A force sensor configured to measure the force applied to the anvil assembly by the transmission assembly, A display, A controller, Actuating the motor to move the anvil assembly relative to the reload assembly until the clamp distance is reached, Comparing the force measured at the clamp distance with the minimum clamp force limit value, Outputting an alert to the display in response to the measured force being lower than the minimum clamp force limit value, A controller configured as such, A surgical device comprising.

16. The surgical device according to claim 15, wherein the controller is further configured to determine a thickness indication of an alternative reload assembly based on the measured force.

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

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

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