Systems and methods for power surgical circular stapler instrument rotation adjustment

Abstract

The present disclosure relates to a system and method for power surgical circular stapling instrument rotation adjustment. The method for power surgical stapling instrument rotation adjustment includes measuring a change in a position of a first motor shaft of a surgical stapling instrument relative to a stored rotational check position of the first motor shaft resulting from a manual rotation of an adapter assembly of the surgical stapling instrument relative to a handle assembly of the surgical stapling instrument, determining a distance traveled by a first drive assembly of the adapter assembly of the surgical stapling instrument resulting from the change in the position of the first motor shaft, comparing the determined distance traveled to a first stored rotational check position of the first motor shaft, determining whether the compared distance falls within a predetermined acceptable range of rotational positions, and adjusting the position of the drive shaft if the compared distance is not within the predetermined range.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 052,583, filed July 16, 2020, the entire contents of which are hereby incorporated by reference. Technical Field

[0003] This disclosure generally relates to surgical anastomosis instruments, and more specifically to systems and methods for rotational adjustment of powered surgical circular staplers. Background Technology

[0004] Anastomosis is the surgical joining of individual hollow organ segments. Typically, an anastomosis procedure is performed postoperatively, in which diseased or defective segments of the organ are removed, and the remaining end segments of the organ are joined via surgical staplers. Depending on the desired anastomosis process, the end segments may be joined using, for example, circular or side-to-side organ reconstruction methods.

[0005] In circular anastomosis procedures, the remaining end segments of the organ are joined using surgical staplers that drive an array of circular staples through the end segments and simultaneously remove any tissue within the driven array of staples to clear tubular passageways within the organ. Typically, these surgical staplers include a reloading assembly, an adapter assembly, and a handle assembly. The reloading assembly is detachable from the adapter assembly and is disposable. To provide cost savings, the adapter assembly can be removed from the handle assembly for sterilization and cleaning.

[0006] In known powered staplers, the handle assembly includes a motor, which is coupled via a gear assembly to a drive assembly within an adapter assembly. Actuation of the motor causes axial movement of the drive assembly, influencing various operations of the stapler, namely clamping, firing, and cutting. The relative position of the motor to the drive assembly is determined to calculate the actuation stroke required for proper tissue treatment.

[0007] In some powered instruments, an adapter assembly is connected to a handle assembly via a manually rotated knob that rotates the adapter assembly relative to the handle assembly to facilitate repositioning of the tool assembly within the body cavity. During surgical procedures, manual rotation of the adapter assembly relative to the handle assembly alters the relative position of the motor and drive assembly and affects the actuation stroke required for proper tissue handling.

[0008] A power handle assembly that can continuously identify when recalibration of surgical staplers is needed is required. Summary of the Invention

[0009] According to the present disclosure, a method for power surgical stapling instrument rotation adjustment, the method comprising measuring a change in a position of a first motor shaft of a surgical stapling instrument relative to a stored rotational check position of the first motor shaft resulting from a manual rotation of an adapter assembly of the surgical stapling instrument relative to a handle assembly of the surgical stapling instrument, determining a distance traveled by a first drive assembly assembly of the adapter assembly of the surgical stapling instrument resulting from the change in the position of the first motor shaft, comparing the determined distance traveled to the first stored rotational check position of the first motor shaft, determining whether the compared distance falls within a predetermined acceptable range of rotational positions, and adjusting the position of the drive shaft if the compared distance is not within the predetermined range.

[0010] In one aspect, the method can further comprise determining a rotation compensation value based on a difference between the predetermined rotational position and the compared distance. The adjusting of the position of the drive shaft can be based on the rotation compensation value.

[0011] In another aspect, the method can further comprise determining a distance traveled by a second drive assembly.

[0012] In yet another aspect, the determined distance traveled by the second drive assembly can be based on a ratio measure relationship between a first gear ratio of the first drive assembly and a second gear ratio of the second drive assembly.

[0013] In one aspect, the first gear can be associated with a first mode and the second gear is associated with a second mode of the surgical stapling instrument.

[0014] In another aspect, the determining of the rotational check position can be based on a predetermined distance traveled by the first drive assembly.

[0015] In yet another aspect, the method can further comprise displaying a graphical warning on a display indicating an invalid rotation if the first drive assembly can not be in a valid position.

[0016] In still yet another aspect, the method can further comprise calculating a clamp percentage based on the determined distance traveled by the first drive assembly.

[0017] In still yet another aspect, the first mode can comprise a clamping function.

[0018] According to the present disclosure, a surgical circular stapling instrument includes an adapter assembly, a handle assembly, a processor, and a memory. The adapter assembly includes an anvil assembly including an anvil head and an anvil center rod extending proximally from the anvil head, a reload assembly including an annular cartridge of staples, a staple pusher, and a first drive assembly including a first lead screw and a first nut configured to move through a predetermined stroke to move the anvil assembly relative to the cartridge. The handle assembly includes a first motor shaft configured to advance the first drive assembly. The memory includes instructions stored thereon that, when executed, cause the surgical circular stapling instrument to verify a position of the first motor shaft relative to a stored rotational check position of the first motor shaft resulting from a manual rotation of the adapter assembly of the surgical stapling instrument relative to the handle assembly of the surgical stapling instrument, determine a distance traveled by the first drive assembly of the adapter assembly of the surgical stapling instrument resulting from the change in position of the first motor shaft, compare the determined distance traveled to the first stored rotational check position of the first motor shaft, determine whether the compared distance falls within a predetermined acceptable range of rotational positions, and adjust the position of the drive shaft if the compared distance is not within the predetermined range.

[0019] In another aspect, the instructions, when executed, can further cause the surgical stapling instrument to determine a rotational compensation value based on a difference between the predetermined rotational position and the compared distance. The adjusting of the position of the drive shaft can be based on the rotational compensation.

[0020] In yet another aspect, the adapter assembly can further include a second drive assembly including a second lead screw and a second nut, the second lead screw being movable through a predetermined stroke to move the staple pusher relative to the cartridge. The handle assembly can further include a second motor including a second motor shaft configured to advance the second drive assembly. The instructions, when executed, can further cause the surgical stapling instrument to determine a distance traveled by the second drive assembly.

[0021] In still yet another aspect, the determined distance traveled by the anvil assembly can be based on a ratio measure relationship between a first gear ratio of the first drive assembly and a second gear ratio of the second drive assembly.

[0022] In yet another aspect, the first gear is associated with a first mode and the second gear can be associated with a second mode of the surgical stapling instrument.

[0023] In still yet another aspect, the determining of the rotational check position can be based on a predetermined distance traveled by the first drive assembly.

[0024] In still yet another aspect, the instructions, when executed, can further cause the surgical stapling instrument to display a graphical warning on a display indicating an invalid rotation if the first drive assembly is not in an active position.

[0025] In yet another aspect, the instructions, when executed, can further cause the surgical stapling instrument to emit an error tone indicating an invalid rotation if the first drive assembly is not in an active position

[0026] In one aspect, the instructions, when executed, can further cause the surgical stapling instrument to calculate a clamp percentage based on a determined distance traveled by the first drive assembly.

[0027] According to the present disclosure, a non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform a method for surgical stapling instrument rotation adjustment, the method comprising measuring a change in a position of a first motor shaft of a surgical stapling instrument relative to a stored rotation check position of the first motor shaft resulting from a manual rotation of an adapter assembly of the surgical stapling instrument relative to a handle assembly of the surgical stapling instrument, determining a distance traveled by a first drive assembly of the adapter assembly of the surgical stapling instrument resulting from the change in the position of the first motor shaft, comparing the determined distance traveled to the first stored rotation check position of the first motor shaft, determining whether the compared distance falls within a predetermined acceptable range of rotation positions, and adjusting the position of the drive shaft if the compared distance is not within the predetermined range. BRIEF DESCRIPTION OF DRAWINGS

[0028] Systems and methods for powered circular stapler instrument rotation adjustment are disclosed herein with reference to the accompanying drawings, wherein:

[0029] Figure 1 is a perspective view of a surgical stapling instrument according to the present disclosure;

[0030] Figure 2A is a side cross-sectional view taken through a proximal portion of an adapter assembly of a surgical stapling instrument shown in Figure 1

[0031] Figure 2B is a cross-sectional view taken through a distal portion of an adapter assembly and tool assembly of a surgical stapling instrument shown in Figure 1

[0032] Figure 2C is a cross-sectional view taken through a distal portion of a handle assembly of a surgical stapling instrument shown in Figure 1

[0033] Figure 3 is a block diagram of a controller provided according to the present disclosure and configured for use with a surgical system of Figure 1 ; and

[0034] Figure 4 is a flowchart of a method for rotation check according to the present disclosure. DETAILED DESCRIPTION ​​​

[0035] The disclosed surgical instrument will now be described in detail with reference to the drawings, in which like reference numerals designate each of the several views. However, as will be understood by those skilled in the art, the various aspects of the disclosure can be embodied in various forms. To avoid unnecessary detail, well-known functions or constructions are not described in detail. Therefore, the specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriate detailed structure. Further, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and like terms are used for purposes of aiding understanding of the description, and are not intended to limit the disclosure.

[0036] In this description, the term“proximal” is generally used to refer to the portion of the device closer to the clinician, while the term“distal” is generally used to refer to the portion of the device further from the clinician. Further, the term“clinician” is generally used to refer to medical personnel, including doctors, nurses, and support staff.

[0037] When the clinician manually changes the position of the adapter assembly relative to the handle assembly, the disclosed system and method uses software to correlate the position of the motor of the handle assembly of the surgical stapling instrument with the position of the drive assembly of the adapter assembly of the surgical stapling instrument. This correlation allows the surgical stapling instrument to provide the proper clamping gap, stapling stroke (staple formation), and cutting stroke during operation of the surgical stapling instrument.

[0038] During calibration of the surgical stapling instrument, the stroke of each of the drive assemblies of the surgical stapling instrument used to perform the various functions of the instrument (i.e., clamping, stapling, and cutting) is set to a predetermined distance (rotation check position). Throughout the different stages of the surgical procedure in which the surgical stapling instrument is used to treat tissue, the adapter assembly of the surgical stapling instrument can be manually rotated by the clinician relative to the handle assembly of the surgical stapling instrument prior to actuating the surgical stapling instrument to reposition the tool assembly within the body cavity of the patient. This change in position of the adapter assembly relative to the handle assembly can change the relative position of the motor within the handle assembly and the drive assembly within the adapter assembly, and thus change the appropriate stroke of the drive assembly needed to properly actuate the tool assembly. Therefore, rotation of the adapter assembly relative to the handle assembly can require the surgical stapling instrument to be compensated for or recalibrated prior to actuating the surgical stapling instrument. The present disclosure provides a method of recalibrating the motor position and the drive assembly position when the relative position of the motor and the drive assembly has been changed due to the manual rotation of the adapter assembly by the clinician relative to the handle assembly prior to actuating the surgical stapling instrument.

[0039] Figure 1 A surgical stapling instrument is illustrated generally as a stapling instrument 10. The stapling instrument 10 is a circular stapling instrument and includes a handle assembly 20, an adapter assembly 100 extending distally from the handle assembly 20, a reload assembly 16 supported on a distal portion of the adapter assembly 100, an anvil assembly 50 operably coupled to the adapter assembly 100, and a controller 300 supported within the handle assembly 20. Figure 3 ) The reload assembly 16 supports an annular cartridge 48 including a plurality of staples (not shown). The anvil assembly 50 includes an anvil head 28 including a staple forming surface 29 Figure 2B ) that defines a staple forming recess 48a Figure 2B ) and is movable relative to the cartridge 48 between open and clamped positions.

[0040] The handle assembly 20 is illustrated as a powered assembly and includes a fixed grip 22, an actuation button 24 for controlling firing of staples (not shown) from the annular cartridge 48 of the reload assembly 16, and access buttons 26a, 26b for controlling axial displacement of the anvil assembly 50 toward and away from the reload assembly 16 between open and clamped positions. For a detailed description of the structure and function of an exemplary powered handle assembly, reference can be made to U.S. Patent Application Publication Nos. 2020 / 0015820 and 2019 / 0343517. Although the present disclosure illustrates a powered assembly, it is contemplated that the advantages of the present disclosure as described in detail below are applicable to robotically actuated surgical instruments as well.

[0041] The handle assembly 20 can include an electrical assembly including a strain gauge 51 Figure 2B ) configured to determine whether a motor 152, 154, 156 Figure 2C ) of the stapling instrument 10 is under load or whether it is within a predetermined load range, the load being caused by tissue clamped between the anvil assembly 50 and the cartridge 48.

[0042] Figure 2A An adapter assembly 100 is illustrated including a fixed portion 102 coupled to the handle assembly 20 Figure 1 ) and a rotatable portion 104 rotatably coupled to the fixed portion 102. The fixed portion 102 includes a first drive shaft 106, a second drive shaft 108, and a third drive shaft 110 coupled to motors 152, 154, 156 Figure 1 ) supported within the handle assembly 20 Figure 2CThe drive shafts 152a, 154a, and 156a of the adapter assembly 100. The drive shaft 106 in the fixed portion 102 of the adapter assembly 100 is geared to the drive assembly 114 in the rotatable portion 104 of the adapter assembly 100 to control the movement of the anvil assembly 50 relative to the staple cartridge 48 between the open and clamping positions. The drive shaft 108 in the fixed portion 102 of the adapter assembly 100 is geared to the drive assembly 119 in the rotatable portion 104 of the adapter assembly 100 to control the movement of the anvil assembly 50 relative to the staple cartridge 48 during reloading of the assembly 16. Figure 1 The pusher assembly 61 (inside) Figure 2B The movement of ) to control the movement from the pin cartridge 48 ( Figure 1 The firing pin. The drive shaft 110 in the fixed portion 102 of the adapter assembly 100 is connected to the drive assembly 116 via gears to control the cutting of tissue. Drive assemblies 114, 116, 119 ( Figure 2A Each of the components includes a screw and a nut (not described in detail herein), wherein the nut is driven relative to the screw to achieve longitudinal movement of the screw.

[0043] The rotatable portion 104 of the adapter assembly 100 includes a rotary knob 120 rotatably coupled to and about the axle portion 126 of the fixed portion 102 of the adapter assembly 100. The rotary knob 120 is coupled to the outer tube 122 of the rotatable portion 104 of the adapter assembly 100 such that manual rotation of the rotary knob 120 about its longitudinal axis “X” causes the rotatable portion 102 of the adapter assembly 100 to rotate relative to the fixed portion 102 of the adapter assembly 100 and relative to the handle assembly 20 about the longitudinal axis “X”. U.S. Patent Publication No. 2018 / 0353186 (“186 Publication”) includes a detailed description of the construction of a suitable adapter assembly.

[0044] Figure 1 The reloading assembly 16 is described as being supported on the distal portion of the outer tube 122 of the adapter assembly 100 and including a housing 46 supporting the staple cartridge 48. In aspects of this disclosure, the staple cartridge 48 defines an annular row of staple receiving recesses 48a for receiving staples (not shown). In some aspects of this disclosure, the reloading assembly 16 is releasably coupled to the distal portion of a tubular shaft (not shown) to facilitate replacement of the annular staple cartridge 48 after each use, thereby facilitating the reuse of the surgical instrument 10. A detailed description of exemplary aspects of the powered handle assembly and the releasable adapter assembly can be found in U.S. Patent No. 10,085,744.

[0045] The staple storage recess 48a of the staple cartridge 48 Figure 2BEach of the support staples (not shown) in the staple cartridge 48 can be fired from the staple cartridge 48 via actuation of the actuation button 24 of the actuation handle assembly 20. The housing shell 46 of the reload assembly 16 defines an annular cavity 60. The annular cavity 60 supports a staple pusher 61 ( Figure 2A ) and an annular knife 62 of knife drivers nuts 264 of the drive assembly 119( Figure 2A ) and the drive assembly 116( Figure 2B ), respectively, such that the staple pusher 61 and the annular knife 62 are movable relative to the staple cartridge 48 to eject staples from the staple cartridge 48 and to dissect or cut tissue positioned within an annulus defined by the staple cartridge 48. As the staples (not shown) are fired from the staple cartridge 48, the staples are driven into and form within staple-forming depressions 29a( Figure 2B ) of a staple-forming surface 29 of the anvil head 28 of the anvil assembly 50.

[0046] As described above, the first, second, and third shafts 106, 108, and 110 of the adapter assembly 100 are coupled to the powered handle assembly 20 by motor shafts 152a, 154a, 156a that are coupled to the motors 152, 154, 156( Figure 2C ) within the handle assembly 20 by a gear assembly (not shown). Rotation of the motor shafts 152a, 154a, 156a by the motors 152, 154, 156 is controlled by the controller 300 such that the motors 152, 154, 156 move the drive shafts 106, 108, and 110, move the drive assembly 114, the drive assembly 119, and the drive assembly 116 through a predetermined stroke, move the anvil assembly 50 relative to the staple cartridge 48 from an open position to a clamped position, define a predetermined tissue gap between the anvil assembly 50 and the staple cartridge 48, advance a pusher (not shown) within the housing shell 46 to eject staples from the staple cartridge 48, and advance a knife carriage (not shown) within the housing shell 46 to cut tissue. The predetermined stroke is calculated from a reference position that is based on a rotational position of the motor drive shafts 152a, 154a, 156a within the handle assembly 20.

[0047] Rotation of the adapter assembly 100 relative to the handle assembly can change the position of the drive assemblies 114, 119, 116, thereby requiring a change in stroke. The disclosed method determines whether the adapter assembly 100 of the stapling instrument 10 has been rotated relative to the handle assembly 20 of the stapling instrument 10 throughout the surgical procedure by performing a series of staple calibration checks prior to actuation of the surgical instrument 10. The gear ratios of the gear assemblies interconnecting the motor shafts 152a, 154a, 156a with the drive assemblies 114, 116, 119 are fixed relative to their specific functions. Thus, the distance traveled when the stapling instrument 10 is rotated is a ratioed measure between the stapling, clamping, and cutting functions. Using these known ratios, a calibration distance difference window (e.g., range) can be established for each rotational position of the adapter assembly 100 relative to the handle assembly 20 (e.g., 0°, 90°, or 180°). Each respective position can have an associated tolerance window (e.g., range) in which a normal calibration distance difference can be reported.

[0048] When the adapter assembly 100 of the stapling instrument 10 has been rotated relative to the handle assembly 20 and with the disclosed rotation verification method, the position of the anvil assembly 50 relative to the cartridge 48 of the surgical instrument 10 will be adjusted based on the difference window into which the determined distance falls. This verification occurs when there is no load on the surgical instrument 10. The disclosed method maintains consistency in staple formation, maintains a consistent tissue gap, prevents tissue over compression, and reduces surgical time, reducing surgical intervention.

[0049] When the rotatable portion 104 of the adapter assembly 100 is rotated about the longitudinal axis “X” of the rotation knob 120 relative to the fixed portion 102 of the adapter assembly 100 to reposition the reload assembly 16 and the anvil assembly 50 within the body cavity of the patient, Figure 2A ) the rotation of the rotatable portion 104 of the adapter assembly 100 relative to the handle assembly 20 changes the reference position of each of the drive assemblies 114, 116, 119 within the adapter assembly 100. As such, prior to actuation of the stapling instrument 10, the stapling instrument 10 needs to be recalibrated.

[0050] The drive assembly 119( Figure 2A ) includes a staple guide screw 253 and a staple driver nut 254, wherein the staple driver nut 254 is driven relative to the staple guide screw 253 to effect longitudinal movement of the staple guide screw 253. The drive assembly 116( Figure 2A ) includes a knife guide screw 263 and a knife driver nut 264, wherein the knife driver nut 264 is driven relative to the knife guide screw 263 to effect longitudinal movement of the knife guide screw 263. The drive assembly 114( Figure 2B) includes a lead screw 125 and a nut 127, where the nut 127 is driven relative to the lead screw 125 to effect longitudinal movement of the lead screw 125.

[0051] Figure 3 A controller 300 according to the present disclosure is described, including a processor 320 connected to a computer readable storage medium or memory 330. The computer readable storage medium or memory 330 can be a volatile type of memory, such as RAM, or a non-volatile type of memory, such as flash memory medium, disk medium, etc. In various aspects of the present disclosure, the processor 320 can be another type of processor, such as but not limited to a digital signal processor, a microprocessor, an ASIC, a graphics processing unit (GPU), a field programmable gate array (FPGA), or a central processing unit (CPU). In certain aspects of the present disclosure, in contrast to the processor, network inference can also be accomplished in a system that can implement weights as mediators, chemically or other inference calculations.

[0052] In aspects of the present disclosure, the memory 330 can be a random access memory, a read only memory, a disk memory, a solid state memory, an optical disk memory, and / or another type of memory. In some aspects of the present disclosure, the memory 330 can be separate from the controller 300 and can communicate with the processor 320 through a communication bus of a circuit board and / or through a communication cable such as a Serial ATA cable or other type of cable. The memory 330 includes computer readable instructions that can be executed by the processor 320 to operate the controller 300. In other aspects of the present disclosure, the controller 300 can include a network interface 340 to communicate with other computers or servers. A storage device 310 can be used to store data.

[0053] The controller 300 includes a plurality of sensors (not shown) configured to measure operating conditions of the motors 152, 154, 156. The sensors can include, for example, voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors can measure voltage, current, and other electrical characteristics of the electrical energy supplied to the motors 152, 154, 156. The sensors can also measure angular velocity (e.g., rotational speed), such as revolutions per minute (RPM), torque, temperature, current draw, and other operating characteristics of the motors 152, 154, 156. Angular velocity can be determined by measuring rotation of the motors 152, 154, 156 or drive shafts (not shown) coupled to them and rotatable by the respective motors. The position of various axially movable drive shafts can also be determined by using various linear sensors disposed in or proximate to the shafts, or extrapolated from RPM measurements. In aspects, torque can be calculated based on the adjusted current draw of the motor at a constant RPM. In other aspects, the controller 300 can measure time and process the above-described values over time, including, for example, integration and / or differentiation, to determine rates of change of the measured values. The controller 300 is also configured to determine distances traveled by various components of the adapter assembly 100 and / or reload assembly 16 by counting the revolutions of the motors 152, 154, and 156.

[0054] The disclosed methods can be run on the controller 300 or on a user device, including, for example, on a mobile device, IoT device, or server system.

[0055] Figure 4 A flowchart illustrating a computer-implemented method 400 for controlling a stapling instrument 10 to determine adapter rotation and allow recalibration of the stroke of the drive assemblies 114, 119, and 116 to ensure the correct stroke is produced after actuation of the stapling instrument 10 is described. During calibration of the stapling instrument 10 Figure 1 ) the cut stroke of the drive assembly 116 is set to a predetermined distance, which can be defined by a predetermined number of turns of the staple driver nut 264 relative to the staple guide screw 263. The clamp stroke of the drive assembly 114 is set to a predetermined distance, which can be defined by a predetermined number of turns of the nut 127 relative to the guide screw 125.

[0056] The clamp stroke, staple firing stroke, and cut stroke are calculated based on the respective reference positions of each of the drive assemblies 114, 116, 119. However, when the adapter assembly 100 is manually rotated relative to the handle assembly 20, the reference positions of each of the drive assemblies 114, 116, 119 within the adapter assembly 100 change, and if the positions are outside of a predetermined range, calibration must be performed.

[0057] When the adapter assembly 100 is first coupled to the handle assembly 20, with the reload assembly 16 fastened to the adapter assembly, the handle assembly 20 performs a calibration to determine the starting hard stop positions. The controller 300 calculates the distance traveled by the motors 152, 154, 156 to determine the hard stop positions. The hard stop positions are the mechanical end stop positions that correspond to a spike in the current draw of the motor related to the torque minimum of the knife driver nut 264( Figure 2A ) and / or the staple driver nut 254( Figure 2A ) on the respective guide screws 263, 253. The hard stop position is determined for each of the motors 152, 154, 156( Figure 2C ). This is accomplished during calibration of the instrument 10 by moving each of the respective drive assemblies 114 until the torque threshold of the respective motor is reached. The rotation check position is the initial predetermined starting point of the drive shafts 106, 108, 110 that can be set when the drive assemblies 114, 116, 119 are moved a predetermined distance, such as a value of turns of the guide screw, for example five turns, from the hard stop position. This can be determined by measuring the turns of the motors 152, 154, 156( Figure 2C ). The rotation check position is stored in the memory of the controller 300.

[0058] A method for operating the surgical instrument 10 is described and can be performed prior to actuating the surgical instrument 10 after the surgical instrument 10 is properly positioned relative to the tissue to be treated, for example stapled. The method is performed prior to the tissue being clamped between the cartridge 48( Figure 1 ) and the anvil assembly 50 and the stroke of the various functions of the stapling instrument 10 (clamping, stapling and cutting the tissue) being readjusted based on the position of the drive assemblies 114, 116, 119 of the adapter assembly 100, which can have changed in response to manipulating the adapter assembly 100 relative to the handle assembly 20.

[0059] Initially, at step 402, the method determines the respective motor shafts 152a, 154b, 156c( Figure 2CThe method can determine a difference between the stored rotational check position and a change in the number of turns of the motor shaft as the motor shaft moves through a predetermined stroke. The rotational check position is the position that the motor shaft should be in, e.g., if the motor shaft moves through a predetermined stroke, a predetermined tissue gap is formed. The predetermined tissue gap and the predetermined stroke are controlled by the controller 300. For example, if the clinician rotates the adapter assembly 100 relative to the handle assembly 20 between a cutting function and a stapling function, the method will measure the movement of the corresponding motor shaft, determine the change in the position of the motor shaft relative to the rotational check position.

[0060] Next, at step 404, the method determines the distance traveled by the motor shaft. Once this is determined, the distance traveled by the drive shaft can be calculated based on a ratio measure relationship between a first gear ratio of a first drive assembly, e.g., drive assembly 114, and a second gear ratio of a second drive assembly, e.g., drive assembly 119. The first gear ratio is associated with a first mode, e.g., the clamping function, and the second gear ratio is associated with a second mode of the stapling instrument 10, e.g., the stapling function. For example, for clamping, the first gear ratio can be about 2: 1 (input turns to output turns at the lead screw 125), and for stapling, the second gear ratio can be about 19: 1 (input turns to output turns at the lead screw 253).

[0061] If the motor shaft 152a, 154b, 156c( Figure 2C ) is within a predetermined position to properly perform the selected function, e.g., clamp tissue or form a staple, at step 406, the method updates the motor shaft position and stores the updated motor shaft position in memory.

[0062] To determine the distance the motor shaft has moved, the rotation of the motor used to rotate the motor shaft and drive the anvil assembly 50 can be measured. For example, the motor can include a predetermined number of "ticks" per revolution (e.g., 36 ticks per revolution) and an encoder can be provided to count the ticks to identify the exact position of the drive shaft 152a, 154a, 156a( Figure 2C ) as the shaft rotates (in response to manual rotation of the adapter assembly 100 relative to the handle assembly 20). Using this information, the position of the drive assemblies 114, 116, and 119 can be determined, e.g., to determine the position of the anvil assembly 50 relative to the staple cartridge 48. An encoder is an electromechanical device that can measure motion or position. An encoder can use an optical sensor to provide an electrical signal in the form of a pulse train, which can in turn be converted to motion, direction, or position. Each step of position is one "tick." For example, an encoder with 360 steps will have 360 "ticks." In various aspects, motor rotation can be determined based on current draw of the motor of the stapling instrument 10 at a hard stop position.

[0063] Next, in step 410, the method calculates the motors 152, 154, 156 for each function (e.g., clamping, fastening, and / or cutting). Figure 2C The method calculates the change in the number of motor clicks (e.g., the number of motor clicks) from the corresponding hard stop position. For example, the method may calculate the change in the number of motor clicks as the adapter assembly 100 rotates relative to the handle assembly 20 after performing the function of clamping tissue and before stapling has begun. The movement of different functions (e.g., clamping, stapling, and / or cutting) is based on their respective gear ratios being proportional to each other. The gear ratio is fixed for its particular function. Therefore, between clamping tissue and stapling tissue (or stapling and cutting), the distance traveled by the corresponding motor shaft as the stapling instrument 10 rotates is measured in a ratio (i.e., proportionally). Based on this ratio, a predetermined range (e.g., a calibration distance difference window) can be used for each of the rotational positions (e.g., 0°, 90°, or 180°).

[0064] Next, in step 412, the method compares the determined distance traveled by the corresponding motor shaft with a predetermined range of each of the rotational positions (e.g., 0°, 90°, or 180°) of the adapter assembly 100 relative to the handle assembly 20. For example, the distance traveled by the motor shaft may have to be within a predetermined range based on the ratio measurement relationship of the gear ratio.

[0065] Next, in step 414, the method determines the rotational position (e.g., 0°, 90°, or 180°) of the adapter assembly 200 relative to the handle assembly 20 based on a predetermined range of each of the rotational positions. For example, the adapter assembly 200 may rotate approximately 93° relative to the handle assembly 20. The predetermined range for the 90° rotational position may be approximately 75° to 105°.

[0066] Next, in step 418, the method determines whether the stapler 10 is in an effective position, i.e., where the tissue gap is within a predetermined range for a determined rotational position (e.g., 0°, 90°, or 180°). The predetermined range of the tissue gap is controlled by the controller 300. If the stapler 10 is not in an effective position ("No" in step 418), then in step 424, the method determines the percentage of patient tissue held. If the stapler is not in an effective position ("Yes" in step 418), then in step 424, the method issues an error tone, and in step 422, the method sends a graphic signal indicating invalid rotation to the display, such as "Error Invalid Rotation (ERR INVALID ROTATE)".

[0067] Next, at step 420, the method determines whether the anvil assembly 50 is in a valid position based on the position of the corresponding motor shaft, i.e., for a determined rotational position (e.g., 0°, 90°, or 180°), the tissue gap is within a predetermined range. In aspects of the present disclosure, the method can determine a rotational compensation value based on a difference between the determined rotational position and the predetermined range. The rotational compensation value is an amount that the motor shaft must rotate to place the motor shaft in a suitable position for performing a selected function (e.g., clamping, stapling, and / or cutting tissue). For example, the method can adjust the drive assembly 114 to adjust the position of the anvil assembly 50 (e.g., proximate the anvil assembly 50) of the stapling instrument 10 to be in a position for proper stapling formation. The rotational compensation value is used to recalibrate the surgical instrument 10 to ensure that the correct stroke for each drive assembly 114, 116, 119 is generated upon actuation to properly treat tissue.

[0068] If the drive assembly is not in a valid position, the method can also display a graphical warning on a display indicating the invalid rotation or emit an error tone indicating the invalid rotation.

[0069] One skilled in the art will appreciate that one or more operations of the method 400 can be performed, repeated, and / or omitted in a different order without departing from the scope of the present disclosure. In various aspects of the present disclosure, the illustrated method 400 can be operated in the controller 300 ( Figure 3 ), in a remote device, or in another server or system. Other variations are considered within the scope of the present disclosure. The operations of the method 400 will be described with respect to a controller, such as the controller 300 of the stapling instrument 10 ( Figure 3 ), but it should be understood that the illustrated operations are also applicable to other systems and components thereof.

[0070] One skilled in the art will appreciate that the instruments and methods specifically described herein, and illustrated in the drawings, are non-limiting. It is contemplated that elements and features can be combined with another element or feature. Also, one skilled in the art will appreciate other features and advantages of the present disclosure.

Claims

1. A non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform a method for power surgical stapling instrument rotation adjustment, the method comprising: measuring a change in a position of a first motor shaft of a surgical stapling instrument relative to a stored rotational check position of the first motor shaft resulting from a manual rotation of an adapter assembly of the surgical stapling instrument relative to a handle assembly of the surgical stapling instrument; determining a distance traveled by a first drive assembly of the adapter assembly of the surgical stapling instrument resulting from the change in the position of the first motor shaft; comparing the determined distance traveled to the stored rotational check position of the first motor shaft; determining whether the compared distance falls within a predetermined acceptable range of rotational positions; and adjusting the position of the first motor shaft if the compared distance is not within the predetermined acceptable range.

2. The non-transitory computer readable medium of claim 1, further comprising: determining a rotational compensation value based on a difference between the predetermined acceptable range of rotational positions and the compared distance, wherein adjusting the position of the first motor shaft is based on the rotational compensation value.

3. The non-transitory computer readable medium of claim 1, further comprising determining a distance traveled by a second drive assembly.

4. The non-transitory computer readable medium of claim 3, wherein the determined distance traveled by the second drive assembly is based on a ratio measure relationship between a first gear ratio of the first drive assembly of a surgical stapling instrument and a second gear ratio of the second drive assembly of a surgical stapling instrument.

5. The non-transitory computer readable medium of claim 4, wherein the first gear ratio is associated with a first mode of operation of the surgical stapling instrument and the second gear ratio is associated with a second mode of operation of the surgical stapling instrument.

6. The non-transitory computer readable medium of claim 2, wherein determining the rotational check position is based on a predetermined distance traveled by the first drive assembly.

7. The non-transitory computer readable medium of claim 1, wherein in the event that the first drive assembly is not in a valid position, the method further comprises displaying a graphical warning on a display indicating an invalid rotational position.

8. The non-transitory computer readable medium of claim 1, wherein in the event that the first drive assembly is not in a valid position, the method further comprises sounding an error tone indicating an invalid rotational position.

9. The non-transitory computer readable medium of claim 1, further comprising calculating a clamp percentage based on the determined distance traveled by the first drive assembly.

10. The non-transitory computer readable medium of claim 5, wherein the first mode comprises a clamping function.

11. A surgical circular stapling instrument, comprising: an adapter assembly comprising: an anvil assembly comprising an anvil head and an anvil center rod extending proximally from the anvil head; A reload assembly comprising an annular staple cartridge comprising a plurality of staples, and a staple pusher; and A first drive assembly comprising a first lead screw and a first nut, the first lead screw movable through a predetermined stroke to move the anvil assembly relative to the staple cartridge; A handle assembly comprising: A first motor comprising a first motor shaft configured to advance the first drive assembly; A processor; and A memory comprising instructions stored thereon that, when executed, cause the surgical circular stapling instrument to: Measure a change in a position of the first motor shaft relative to a stored rotational check position of the first motor shaft resulting from a manual rotation of the adapter assembly of the surgical circular stapling instrument relative to a handle assembly of the surgical circular stapling instrument; Determine a distance traveled by a first drive assembly of the adapter assembly of the surgical circular stapling instrument resulting from the change in the position of the first motor shaft; Compare the determined distance traveled to the stored rotational check position of the first motor shaft; Determine whether the compared distance falls within a predetermined acceptable range of rotational positions; and Adjust the position of the first motor shaft if the compared distance is not within the predetermined acceptable range.

12. The surgical circular stapling instrument of claim 11, the instructions, when executed, further cause the surgical circular stapling instrument to determine a rotational compensation value based on a difference between the predetermined acceptable range of rotational positions and the compared distance, wherein adjusting the position of the first motor shaft is based on the rotational compensation.

13. The surgical circular stapling instrument of claim 11, wherein the adapter assembly further comprises a second drive assembly comprising a second lead screw and a second nut, the second lead screw movable through a predetermined stroke to move the staple pusher relative to the staple cartridge, wherein the handle assembly further comprises a second motor comprising a second motor shaft configured to advance the second drive assembly, and wherein the instructions, when executed, further cause the surgical circular stapling instrument to determine a distance traveled by the second drive assembly.

14. The surgical circular stapling instrument of claim 13, wherein the determined distance traveled by the second drive assembly is based on a ratio measure relationship between a first gear ratio of the first drive assembly and a second gear ratio of the second drive assembly.

15. The surgical circular stapling instrument of claim 14, wherein a first gear is associated with a first mode of the surgical circular stapling instrument and a second gear is associated with a second mode of the surgical circular stapling instrument.

16. The surgical circular stapling instrument of claim 12, wherein determining the rotational check position is based on a predetermined distance traveled by the first drive assembly.

17. The surgical circular stapling instrument of claim 11, the instructions, when executed, further cause the surgical circular stapling instrument to display a graphical warning on a display indicating an invalid rotation if the first drive assembly is not in an active position.

18. The surgical circular stapling instrument of Claim 11, wherein the instructions, when executed, further cause the surgical circular stapling instrument to emit an error tone indicating an ineffective rotation if the first drive assembly is not in an effective position.

19. The surgical circular stapling instrument of Claim 11, wherein the instructions, when executed, further cause the surgical circular stapling instrument to calculate a clamp percentage based on the determined distance traveled by the first drive assembly.

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