Handheld electromechanical surgical system

Abstract

To provide a handheld electromechanical surgical system.SOLUTION: A handheld electromechanical surgical device capable of effectuating a surgical procedure includes a handle assembly having: a power source; at least one motor coupled to the power source; and a controller configured to control the motor. The surgical device includes an adapter assembly having an electrical assembly having a proximal end in communication with the controller of the handle assembly. The surgical device includes a reload configured to selectively connect to a distal end of the adapter assembly. The reload includes: an annular array of staples; an annular staple pusher for ejecting the staples; and a data storage device selectively connectable to a distal end of the electrical assembly. The data storage device receives and stores performance data of the surgical device from the controller of the handle assembly.SELECTED DRAWING: None

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. Patent Application No. 15 / 972,641, filed May 7, 2018, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 517,276, filed June 9, 2017, and U.S. Provisional Patent Application No. 62 / 517,297, filed June 9, 2017. The entire disclosures of all of the foregoing applications are incorporated herein by reference.

[0002] 1.Technical Field The present disclosure relates to surgical devices and, more particularly, to handheld electromechanical surgical systems for performing surgical procedures. [Background technology]

[0003] 2. Background technology One type of surgical device is a circular clamping, cutting, and stapling device. Such devices can be employed in surgical procedures to reattach previously severed rectal segments or similar procedures. Conventional circular clamping, cutting, and stapling instruments have a pistol-shaped or straight-gripping structure having an elongated shaft extending therefrom and a staple cartridge supported at the distal end of the elongated shaft. In this case, a physician can insert the anvil assembly of the circular stapling instrument into the patient's rectum and manipulate the anvil assembly upward along the patient's colonic canal toward the severed rectal segment. The physician can also insert the remainder of the circular stapling instrument (including the cartridge assembly) through the incision toward the severed rectal segment. The anvil assembly and cartridge assembly are approximated toward one another, staples are expelled from the cartridge assembly toward the anvil assembly to form staples in the tissue to achieve the end-to-end anastomosis, and the circular knife is fired to remove the center of a portion of the clamped tissue segments. After achieving the end-to-end anastomosis, the circular stapling device is removed from the surgical site.

[0004] Many surgical device manufacturers have developed product lines with proprietary powered drive systems for operating and / or manipulating the surgical device. Often, the surgical device includes a reusable powered handle assembly, a disposable staple cartridge assembly, and an end effector that is selectively connected to the powered handle assembly prior to use and then disconnected from the staple cartridge assembly, or that is discarded following use or, in some cases, sterilized for reuse.

[0005] The use of powered electric and endo-mechanical surgical staplers, including those with intelligent battery power sources, has grown significantly over the past several decades. The advanced technology and informatics within these intelligent, battery-powered stapling devices provide the ability to collect clinical data, drive design improvements, and ultimately improve patient outcomes. Thus, a need exists for improved powered electric and endo-mechanical surgical staplers that can assess conditions that affect staple formation with the goal of building more intelligent stapling algorithms. Summary of the Invention [Means for solving the problem]

[0006] SUMMARY The present disclosure relates to a handheld electromechanical surgical system for performing surgical procedures.

[0007] According to aspects of the present disclosure, a handheld electromechanical surgical device capable of performing a surgical procedure is provided. The surgical device includes a handle assembly having a power source, at least one motor coupled to the power source, and a controller configured to control the motor. The surgical device includes an adapter assembly coupled to and extending from the handle assembly. The adapter assembly includes a force transmission and rotation conversion assembly for receiving rotation from the at least one motor of the handle assembly and transmitting it to an axially translating force of a drive assembly thereof, and an electrical assembly having a proximal end in communication with the controller of the handle assembly and a distal end. The surgical device includes a reloader configured to selectively connect to a distal portion of the adapter assembly. The reloader includes an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connectable to the distal end of the electrical assembly of the adapter assembly. The data storage device receives and stores performance data of the surgical device from the controller of the handle assembly.

[0008] The data storage device of the refill unit may include pre-stored information thereon prior to any use thereof, The pre-stored information may include at least one of a lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or demonstration mode.

[0009] The data storage device of the refill unit may be configured so that performance data is written to and stored thereon during or following any use thereof.

[0010] The data storage device of the refill portion may be configured such that performance data is written to and stored thereon following successful or unsuccessful firing of the surgical device.

[0011] The performance data written and stored in the data storage device of the refill unit may include clamping force for a surgical procedure, stapling force for a surgical procedure, cutting force for a surgical procedure, maximum clamping force, maximum stapling force, or maximum cutting force.

[0012] The performance data may be written to and stored in a controller in the handle assembly.

[0013] During or following any use of the surgical device, performance data relating to the use of the surgical device may be written to and stored in the data storage device of the refill unit.

[0014] Following successful or unsuccessful firing of the surgical device, performance data relating to the successful or unsuccessful firing may be written and stored in the data storage device of the refill unit.

[0015] The performance data written and stored in the data storage device of the refill unit may include clamping force for a surgical procedure, stapling force for a surgical procedure, cutting force for a surgical procedure, maximum clamping force, maximum stapling force, or maximum cutting force.

[0016] The data storage device of the refill unit may include pre-stored information thereon prior to any use thereof, the pre-stored information including at least one of lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or demonstration mode.

[0017] The performance data may be written to and stored in a controller in the handle assembly.

[0018] According to another aspect of the present disclosure, there is provided a surgical stapler reloader configured for selective connection to a surgical device capable of performing a surgical procedure, the surgical stapler reloader including an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connectable to an electrical assembly of the surgical device, the data storage device receiving and storing performance data from a controller of the surgical device.

[0019] The data storage device of the refill unit may include pre-stored information thereon prior to any use thereof, the pre-stored information including at least one of lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or demonstration mode.

[0020] The data storage device of the refill unit may be configured so that performance data is written to and stored thereon during or following any use thereof.

[0021] The data storage device of the refill portion may be configured such that performance data is written to and stored thereon following successful or unsuccessful firing of the surgical device.

[0022] The performance data written and stored in the data storage device of the refill unit may include clamping force for a surgical procedure, stapling force for a surgical procedure, cutting force for a surgical procedure, maximum clamping force, maximum stapling force, or maximum cutting force.

[0023] According to yet another aspect of the present disclosure, a method of collecting surgical procedure performance data for a surgical device is provided. The method includes performing a surgical procedure with the surgical device. The surgical device includes a handle assembly having a power source, at least one motor coupled to the power source, and a controller configured to control the motor, and a reloader configured to selectively connect to the handle assembly. The reloader includes an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connected to the controller of the handle assembly. The method includes communicating the surgical device performance data from the controller to the data storage device of the reloader and storing the surgical device performance data in the data storage device of the reloader.

[0024] The method may further include communicating and storing performance data in a data storage device of the refill portion following successful or unsuccessful firing of the surgical device.

[0025] The performance data written and stored in the data storage device of the refill unit may include clamping force for the surgical procedure, stapling force for the surgical procedure, cutting force for the surgical procedure, maximum clamping force, maximum stapling force, or maximum cutting force.

[0026] The method may further include writing the performance data to a controller of the surgical device and storing the performance data.

[0027] The method may further include disconnecting the refill unit from the surgical device and accessing performance data stored in a data storage device of the refill unit.

[0028] Storing the surgical device performance data in the refill unit's data storage device can occur while the surgical device is in the field of use, and accessing the performance data stored in the refill unit's data storage device can occur while the refill unit is outside the field of use.

[0029] According to a further aspect of the present disclosure, there is provided a method of operating a surgical device including a surgical stapler reloader and an anvil assembly having a head assembly movable between a non-tilted orientation and a tilted orientation for cooperation with the surgical stapler reloader to form a plurality of surgical staples, the method including monitoring an axial distance of the tilted head assembly relative to the reloader following full firing of the surgical device and following tilting of the head assembly of the anvil assembly from the non-tilted orientation to the tilted orientation.

[0030] The method may further include monitoring a force acting on the anvil assembly as the anvil assembly is translated toward the refill station.

[0031] The method may further include stopping axial translation of the anvil assembly when the force acting on the anvil assembly exceeds a predetermined threshold.

[0032] The method may further include monitoring a force acting on the tilt head assembly of the anvil assembly as the tilt head assembly is translated toward the refill station.

[0033] The method may further include stopping translation of the tilt head assembly toward reloading when the force acting on the tilt head assembly exceeds a predetermined threshold.

[0034] According to the method, an increase in the monitored force during axial translation of the anvil assembly can indicate that tissue is being captured between the tilt head assembly and the refill portion.

[0035] The method may further include activating an alert when the force acting on the anvil assembly exceeds a predetermined threshold.

[0036] The monitoring may be performed by a controller of the surgical device.

[0037] According to the method, the refill portion may be circular and may include a tissue contacting surface defining a refill portion plane that is orthogonal to an axis of translation of the anvil assembly, and the head assembly of the anvil assembly may be circular and may include a tissue contacting surface defining an anvil head plane that is (1) parallel to the refill portion plane when the head assembly is in the untilted orientation and (2) angled relative to the refill portion plane when the head assembly is in the tilted orientation. The method may include monitoring when an outer radial edge of the head assembly is relatively close to the tissue contacting surface of the refill portion while the head assembly is in the tilted orientation.

[0038] The method may further include monitoring an axial position of a trocar member of the surgical device relative to the refill portion to determine when the tilt head assembly of the anvil assembly is relatively close to the refill portion.

[0039] According to yet another aspect of the present disclosure, a method for operating a surgical device including a removable surgical stapler reloader is provided, the method including attaching a selected surgical stapler reloader to the surgical device, a controller of the surgical device reading information stored on the selected surgical stapler reloader, and setting a maximum cutting stroke for a knife of the selected surgical stapler reloader based on the information recorded on the selected surgical stapler reloader.

[0040] The method may further include the controller of the surgical device monitoring an axial position of a knife of the selected surgical stapler reloader relative to a housing of the selected surgical stapler reloader.

[0041] The information stored in the selected surgical stapler reload unit may include at least one of a staple size, a knife diameter, a lumen size, a minimum cutting stroke length, or a maximum cutting stroke length for the selected surgical stapler reload unit.

[0042] The method may further include setting a minimum cutting stroke for the knife of the selected surgical stapler reloader based on information recorded on the selected surgical stapler reloader.

[0043] The controller of the surgical device may set the cutting stroke for the selected surgical stapler reload.

[0044] The selected surgical stapler refill unit may be a first selected surgical stapler refill unit, and the method may include replacing the first selected surgical stapler refill unit with a second selected surgical stapler refill unit and setting a maximum cutting stroke for a knife of the second selected surgical stapler refill unit based on information stored in the second selected surgical stapler refill unit.

[0045] The cutting stroke for the knife of the first selected surgical stapler refill may be different from the cutting stroke for the knife of the second selected surgical stapler refill.

[0046] Each surgical stapler reloader may be an annular surgical stapler reloader including an annular knife and an annular array of staples.

[0047] According to a further aspect of the present disclosure, a method of operating a surgical device is provided that includes a handheld electromechanical surgical device capable of operating a surgical refill unit capable of performing a surgical procedure, and a surgical adapter assembly for selectively electrically and mechanically interconnecting the surgical device and the removable surgical refill unit. The method includes mechanically and electrically attaching the adapter assembly to the surgical device, a main controller of the surgical device interrogating an event log of an electronic temperature sensor of the adapter assembly, and when the interrogation indicates that the adapter assembly has undergone a sterilization cycle, the main controller of the surgical device enabling operation of the surgical device to perform operations of the surgical refill unit via the adapter assembly.

[0048] The method may further include logging sterilization cycles for the adapter assembly by an electronic temperature sensor in the adapter assembly.

[0049] The method may further include logging the temperature of the sterilization cycle with an electronic temperature sensor in the adapter assembly.

[0050] The method may further include logging the maximum temperature of the sterilization cycle by an electronic temperature sensor in the adapter assembly.

[0051] The method may further include logging the duration of the sterilization cycle with an electronic temperature sensor in the adapter assembly.

[0052] The method may further include disabling the adapter assembly when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained.

[0053] The method may further include disabling the surgical device when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained.

[0054] The method may further include the main controller of the surgical device disabling the adapter assembly when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained.

[0055] The method may further include the main controller of the surgical device interrogating a number of sterilization cycles registered by the electronic temperature sensor.

[0056] The electronic temperature sensor may be a thermistor. The present invention provides, for example, the following. (Item 1) 1. A handheld electromechanical surgical device capable of performing a surgical procedure, the surgical device comprising: 1. A handle assembly comprising: Power supply and at least one motor coupled to the power source; a controller configured to control the motor; and an adapter assembly coupled to and extending from the handle assembly, a force transmission and rotation conversion assembly for receiving rotation from the at least one motor of the handle assembly and transmitting it to an axially translating force of the drive assembly; an adapter assembly including an electrical assembly having a proximal end in communication with the controller of the handle assembly and a distal end; a reloader configured to selectively connect to a distal portion of the adapter assembly, an annular array of staples; an annular staple pusher for ejecting the staples; a reloading unit including a data storage device selectively connectable to the distal end of the electrical assembly of the adapter assembly, the data storage device receiving and storing performance data of the surgical device from the controller of the handle assembly. (Item 2) The surgical device described in the preceding item, wherein the data storage device of the refilling portion includes information pre-stored thereon prior to any use thereof, the pre-stored information including at least one of lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or demonstration mode. (Item 3) 10. The surgical device of claim 1, wherein the data storage device of the refill portion is configured such that performance data is written to and stored thereon during or following any use thereof. (Item 4) 10. A surgical device according to any of the preceding items, wherein the data storage device of the refill portion is configured such that performance data is written to and stored thereon following successful or unsuccessful firing of the surgical device. (Item 5) 10. The surgical device of claim 9, wherein the performance data written and stored in the data storage device of the refill unit includes a clamping force for the surgical procedure, a stapling force for the surgical procedure, a cutting force for the surgical procedure, a maximum clamping force, a maximum stapling force, or a maximum cutting force. (Item 6) The surgical device of any preceding item, wherein the performance data is written and stored in the controller of the handle assembly. (Item 7) A surgical device according to any of the preceding items, wherein during or following any use of the surgical device, performance data relating to the use of the surgical device is written and stored in the data storage device of the refill unit. (Item 8) A surgical device according to any of the preceding items, wherein following successful or unsuccessful firing of the surgical device, performance data relating to the successful or unsuccessful firing is written and stored in the data storage device of the refill unit. (Item 9) 10. The surgical device of claim 9, wherein the performance data written and stored in the data storage device of the refill unit includes a clamping force for the surgical procedure, a stapling force for the surgical procedure, a cutting force for the surgical procedure, a maximum clamping force, a maximum stapling force, or a maximum cutting force. (Item 10) The surgical device of any of the preceding items, wherein the data storage device of the refill portion includes information pre-stored thereon prior to any use thereof, the pre-stored information including at least one of a lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or a demonstration mode. (Item 11) The surgical device of any preceding item, wherein the performance data is written and stored in the controller of the handle assembly. (Item 12) 1. A surgical stapler reloader configured for selective connection to a surgical device capable of performing a surgical procedure, said surgical stapler reloader comprising: an annular array of staples; an annular staple pusher for ejecting the staples; a data storage device selectively connectable to an electrical assembly of the surgical device, the data storage device receiving and storing performance data from a controller of the surgical device. (Item 13) 10. The surgical stapler reloading unit of claim 1, wherein the data storage device of the reloading unit includes information pre-stored thereon prior to any use thereof, the pre-stored information including at least one of a lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, or a demonstration mode. (Item 14) 10. The surgical stapler refill unit of claim 1, wherein the data storage device of the refill unit is configured such that performance data is written to and stored thereon during or following any use thereof. (Item 15) 5. The surgical stapler reloader of claim 4, wherein the data storage device of the reloader is configured such that performance data is written to and stored thereon following successful or unsuccessful firing of the surgical device. (Item 16) 10. The surgical stapler refill unit of claim 1, wherein the performance data written and stored in the data storage device of the refill unit includes a clamping force for the surgical procedure, a stapling force for the surgical procedure, a cutting force for the surgical procedure, a maximum clamping force, a maximum stapling force, or a maximum cutting force. (Item 17) 1. A method for collecting surgical procedure performance data for a surgical device, the method comprising: a handle assembly having a power source, at least one motor coupled to the power source, and a controller configured to control the motor; performing a surgical procedure with a surgical device comprising: a reloader configured to selectively connect to the handle assembly, the reloader comprising an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connected to the controller of the handle assembly; communicating the performance data of the surgical device from the controller thereof to the data storage device of the refill unit; storing the performance data of the surgical device in the data storage device of the refill unit. (Item 18) 10. The method of claim 1, further comprising communicating and storing the performance data in the data storage device of the refill unit following successful or unsuccessful firing of the surgical device. (Item 19) 10. The method of claim 9, wherein the performance data written and stored in the data storage device of the refill unit includes a clamping force for the surgical procedure, a stapling force for the surgical procedure, a cutting force for the surgical procedure, a maximum clamping force, a maximum stapling force, or a maximum cutting force. (Item 20) 10. The method of claim 1, further comprising writing the performance data to the controller of the surgical device and storing the performance data. (Item 21) Disconnecting the refill station from the surgical device; 10. The method of claim 9, further comprising: accessing the performance data stored in the data storage device of the refill station. (Item 22) storing the performance data of the surgical device in the data storage device of the refill unit occurs while the surgical device is in the field of use; 10. The method of claim 1, wherein accessing the performance data stored on the data storage device of the refill unit occurs while the refill unit is outside of its field of use. (Item 23) 1. A method of operating a surgical device including a surgical stapler reloader and an anvil assembly having a head assembly movable between a non-inclined orientation and an inclined orientation for cooperation with the surgical stapler reloader to form a plurality of surgical staples, the method comprising: The method includes monitoring the axial distance of the tilt head assembly relative to the reload section following complete firing of the surgical device and following tilting of the head assembly of the anvil assembly from the untilted orientation to the tilted orientation. (Item 24) 10. The method of claim 1, further comprising monitoring a force acting on the anvil assembly as the anvil assembly is translated toward the refill station. (Item 25) 20. The method of claim 19, further comprising stopping axial translation of the anvil assembly when a force acting on the anvil assembly exceeds a predetermined threshold. (Item 26) 10. The method of claim 1, further comprising monitoring a force acting on the tilt head assembly of the anvil assembly as the tilt head assembly is translated toward the refill station. (Item 27) 10. The method of claim 9, further comprising: stopping translation of the tilt head assembly toward reloading when a force acting on the tilt head assembly exceeds a predetermined threshold. (Item 28) 10. The method of claim 1, wherein an increase in the force monitored during axial translation of the anvil assembly indicates that tissue is captured between the tilt head assembly and the refill section. (Item 29) 10. The method of claim 1, further comprising activating an alert when the force acting on the anvil assembly exceeds the predetermined threshold. (Item 30) 10. The method of claim 1, wherein the monitoring is performed by a controller of the surgical device. (Item 31) the refill portion is circular and includes a tissue contacting surface defining a refill portion plane that is perpendicular to an axis of translation of the anvil assembly; the head assembly of the anvil assembly is circular; the head assembly is parallel to the refill plane when in a non-oriented orientation; a tissue contacting surface defining an anvil head plane that is angled with respect to the refill portion plane when the head assembly is in an inclined orientation; A method according to any of the preceding items, wherein the method includes monitoring when an outer radial edge of the head assembly is relatively close to the tissue contact surface of the refill portion while the head assembly is in the tilted orientation. (Item 32) The method of any of the preceding items, further comprising monitoring the axial position of a trocar member of the surgical device relative to the refill section to determine when the tilt head assembly of the anvil assembly is relatively close to the refill section. (Item 33) 1. A method of operating a surgical device including a removable surgical stapler refill, the method comprising: attaching a selected surgical stapler refill to the surgical device; a controller of the surgical device reading information stored in the selected surgical stapler refill; and setting a maximum cutting stroke for a knife of the selected surgical stapler reloader based on the information recorded on the selected surgical stapler reloader. (Item 34) 10. The method of claim 1, further comprising: the controller of the surgical device monitoring an axial position of the knife of the selected surgical stapler reloader relative to a housing of the selected surgical stapler reloader. (Item 35) 10. The method of claim 1, wherein the information stored in the selected surgical stapler reload unit includes at least one of a staple size, a knife diameter, a lumen size, a minimum cutting stroke length, or a maximum cutting stroke length for the selected surgical stapler reload unit. (Item 36) 10. The method of claim 1, further comprising: setting a minimum cutting stroke for the knife of the selected surgical stapler reloader based on the information recorded on the selected surgical stapler reloader. (Item 37) 10. The method of claim 1, wherein the controller of the surgical device sets the cutting stroke for the selected surgical stapler reload. (Item 38) the selected surgical stapler refill station is a first selected surgical stapler refill station, and the method comprises: replacing the first selected surgical stapler refill with a second selected surgical stapler refill; and setting a maximum cutting stroke for a knife of the second selected surgical stapler reloader based on the information stored in the second selected surgical stapler reloader. (Item 39) 10. The method of claim 1, wherein the cutting stroke for the knife of the first selected surgical stapler reloader is different from the cutting stroke for the knife of the second selected surgical stapler reloader. (Item 40) 10. The method of claim 1, wherein each surgical stapler reload is an annular surgical stapler reload including an annular knife and an annular array of staples. (Item 41) 1. A method of operating a surgical device comprising: a handheld electromechanical surgical device capable of operating a surgical refill unit capable of performing a surgical procedure; and a surgical adapter assembly for selectively electrically and mechanically interconnecting the surgical device and a removable surgical refill unit, the method comprising: mechanically and electrically attaching the adapter assembly to the surgical device; a main controller of the surgical device interrogating an event log of an electronic temperature sensor of the adapter assembly; and when the query indicates that the adapter assembly has undergone a sterilization cycle, the main controller of the surgical device enables operation of the surgical device to perform operations of the surgical refill unit via the adapter assembly. (Item 42) 10. The method of claim 1, further comprising logging a sterilization cycle for the adapter assembly by the electronic temperature sensor of the adapter assembly. (Item 43) 10. The method of claim 1, further comprising logging the temperature of the sterilization cycle with the electronic temperature sensor of the adapter assembly. (Item 44) 10. The method of claim 1, further comprising logging the maximum temperature of the sterilization cycle by the electronic temperature sensor of the adapter assembly. (Item 45) 10. The method of claim 1, further comprising logging the duration of the sterilization cycle by the electronic temperature sensor of the adapter assembly. (Item 46) 10. The method of claim 1, further comprising disabling the adapter assembly when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained. (Item 47) The method of any of the preceding claims, further comprising disabling the surgical device when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained. (Item 48) The method of any of the preceding items, further comprising the main controller of the surgical device disabling the adapter assembly when the maximum temperature of the sterilization cycle is not obtained or when the minimum duration of the sterilization cycle is not obtained. (Item 49) 10. The method of claim 1, further comprising the main controller of the surgical device interrogating a number of sterilization cycles registered by the electronic temperature sensor. (Item 50) 10. The method of claim 1, wherein the electronic temperature sensor is a thermistor. (Item A17) 1. A surgical device, comprising: a handle assembly having a power source, at least one motor coupled to the power source, and a controller configured to control the motor; a reloading section configured to selectively connect to the handle assembly, the reloading section including an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connected to the controller of the handle assembly; Equipped with performance data of the surgical device is communicated from the controller of the handle assembly to the data storage device of the refill unit; The surgical device, wherein the performance data of the surgical device is stored in the data storage device of the refill unit. (Item A18) 2. The surgical device of claim 1, wherein the performance data is transmitted to and stored in the data storage device of the reload unit following successful or unsuccessful firing of the surgical device. (Item A19) 10. A surgical device according to any of the preceding items, wherein the performance data written and stored in the data storage device of the refill unit includes a clamping force for a surgical procedure, a stapling force for the surgical procedure, a cutting force for the surgical procedure, a maximum clamping force, a maximum stapling force, or a maximum cutting force. (Item A20) The surgical device of any of the preceding items, wherein the performance data is written and stored in the controller of the surgical device. (Item A21) the refill station is configured to be disconnected from the surgical device; 2. The surgical device of claim 1, wherein the performance data stored in the data storage device of the refill unit is accessible. (Item A22) storing the performance data of the surgical device in the data storage device of the refill unit occurs while the surgical device is in the field of use; 10. The surgical device of claim 1, wherein the performance data stored in the data storage device of the refill unit is accessible while the refill unit is outside its field of use. (Summary) A handheld electromechanical surgical device capable of performing surgical procedures includes a handle assembly having a power source, at least one motor coupled to the power source, and a controller configured to control the motor. The surgical device includes an adapter assembly having an electrical assembly with a proximal end in communication with the controller of the handle assembly. The surgical device includes a reloading portion configured to selectively connect to the distal end of the adapter assembly. The reloading portion includes an annular array of staples, an annular staple pusher for ejecting the staples, and a data storage device selectively connectable to the distal end of the electrical assembly. The data storage device receives and stores performance data of the surgical device from the controller of the handle assembly. [Brief explanation of the drawings]

[0057] Embodiments of the present disclosure are described herein with reference to the accompanying drawings.

[0058] [Figure 1] FIG. 1 is a perspective view of a handheld surgical device and adapter assembly illustrating their connection with an end effector or reloader according to an embodiment of the present disclosure; [Figure 2] FIG. 2 is a front perspective view of a handle assembly of the surgical device of FIG. 1. [Figure 3] FIG. 3 is a front perspective view, with parts separated, of the handle assembly of FIG. 2; [Figure 4] FIG. 3 is a rear perspective view, with parts separated, of the handle assembly of FIG. 2; [Figure 5] FIG. 10 is a perspective view illustrating insertion of a handle assembly into an outer shell housing assembly according to the present disclosure; [Figure 6] FIG. 10 is a perspective view illustrating a handle assembly inserted into the proximal half of the shell housing assembly in accordance with the present disclosure; [Figure 7] FIG. 1 is a side elevational view of the outer shell housing shown in an open position. [Figure 8] FIG. 2 is a front perspective view of the outer shell housing shown in an open position. [Figure 9] FIG. 10 is a front perspective view of the shell housing shown partially open and with the insertion guide removed. [Figure 10] FIG. [Figure 11] FIG. [Figure 12] FIG. 1 is a front perspective view of the power handle with the inner rear housing separated. [Figure 13] FIG. 1 is a rear perspective view of the power handle with the inner rear housing removed. [Figure 14] FIG. 2 is a perspective view of a power handle core assembly of the power handle. [Figure 15] FIG. 15 is a front perspective view of the motor assembly and control assembly of the power handle core assembly of FIG. [Figure 16] FIG. 16 is a rear perspective view, with parts separated, of the motor assembly and control assembly of FIG. [Figure 17] FIG. 3 is a longitudinal cross-sectional view of the handle assembly of FIG. 2. [Figure 18] FIG. 18 is an enlarged view of the indicated area of ​​detail of FIG. 17; [Figure 19] 19 is a cross-sectional view of the handle assembly taken along line 19-19 of FIG. 17. [Figure 20] FIG. 2 is a front perspective view of the adapter assembly of FIG. 1. [Figure 21] FIG. 21 is a rear perspective view of the adapter assembly of FIGS. 1 and 20. [Figure 22] FIG. 10 is a perspective view showing the connection between the adapter assembly and the handle assembly. [Figure 23] FIG. 1 is a perspective view of an adapter assembly showing a reloading portion secured to its distal end. [Figure 23A] FIG. 24 is an enlarged perspective view of the indicated area of ​​detail of FIG. 23 showing the head assembly of the anvil assembly in a tilted position; [Figure 24] FIG. 10 is a perspective view of the adapter assembly without a reloading portion secured to its distal end. [Figure 25]FIG. 1 is a perspective view of the adapter assembly, partially shown in phantom, showing the first force / rotation transmission / conversion assembly. [Figure 26] FIG. 26 is a perspective view of the first force / rotation transmitting / converting assembly of FIG. 25. [Figure 27] FIG. 26 is a longitudinal cross-sectional view of the first rotatable proximal drive shaft, the first rotatable distal drive shaft, and the coupling member of the first force / rotation transmission / conversion assembly of FIG. 25; [Figure 28] 26 is a perspective view, with parts separated, of the trocar assembly of the first force / rotation transmission / translation assembly of FIG. 25. FIG. [Figure 29] FIG. 26 is a perspective view of the distal end portion of the first force / rotation transmitting / converting assembly of FIG. 25, showing its support block. [Figure 30] 26 is a perspective view of the distal end portion of the first force / rotation transmitting / converting assembly of FIG. 25, with its support block shown in phantom. [Figure 31] FIG. 31 is a cross-sectional view taken along line 31-31 in FIG. 29. [Figure 32] FIG. 32 is a cross-sectional view taken along line 32-32 of FIG. 29. [Figure 33] FIG. 33 is a cross-sectional view taken along line 33-33 in FIG. [Figure 34] FIG. 10 is a perspective view of the adapter assembly, partially shown in phantom, showing the second force / rotation transmission / conversion assembly. [Figure 35] FIG. 35 is a perspective view of the second force / rotation transmission / conversion assembly of FIG. 34. [Figure 36] FIG. 36 is an enlarged view of the indicated area of ​​detail of FIG. 35; [Figure 37] FIG. 35 is a perspective view, with parts separated, of the planetary gear set and staple driver of the second force / rotation transmission / conversion assembly of FIG. [Figure 38] FIG. 28 is a cross-sectional view taken along line 38-38 of FIG. 24. [Figure 39] FIG. 10 is a perspective view of the adapter assembly, partially shown in phantom, showing a third force / rotation transmission / conversion assembly. [Figure 40] FIG. 40 is a perspective view of the third force / rotation transmission / conversion assembly of FIG. 39; [Figure 41] FIG. 41 is an enlarged view of the indicated area of ​​detail of FIG. 40; [Figure 42] FIG. 40 is a perspective view, with parts separated, of the planetary gear set and knife driver of the third force / rotation transmission / conversion assembly of FIG. 39; [Figure 43] FIG. 10 is a perspective view of a distal portion of the adapter assembly. [Figure 44] FIG. 10 is a further perspective view, with parts separated, of a distal portion of the adapter assembly; [Figure 45] FIG. 10 is a rear perspective view of the internal components of the distal end portion of the adapter assembly. [Figure 46] FIG. 46 is an enlarged view of the indicated area of ​​detail of FIG. 45; [Figure 47] FIG. 10 is a front perspective view of the internal components of the distal end portion of the adapter assembly. [Figure 48] FIG. 48 is an enlarged view of the indicated area of ​​detail of FIG. 47; [Figure 49] FIG. 49 is a front perspective view of the internal components of the more distal end of the adapter assembly of FIGS. 45-48. [Figure 50] FIG. 50 is a front perspective view, with parts separated, of the internal components of the more distal end of the adapter assembly of FIG. 49. [Figure 51] FIG. 51 is a perspective view, with parts separated, of a distal end portion of the adapter assembly of FIGS. [Figure 52] FIG. 52 is a perspective view of the distal end portion of the adapter assembly of FIGS. 45-51, showing its electrical assembly. [Figure 53] FIG. 1 is a perspective view of an electrical assembly of the adapter assembly of the present disclosure. [Figure 54] FIG. 54 is a perspective view of a strain gauge assembly of the electrical assembly of FIGS. 52 and 53. [Figure 55] FIG. 55 is a cross-sectional view taken along line 55-55 of FIG. 54. [Figure 56]FIG. 51 is a longitudinal cross-sectional view of the more distal end of the adapter assembly shown in FIGS. 49 and 50. [Figure 57] FIG. 10 is a longitudinal cross-sectional view of a knob assembly of the adapter assembly of the present disclosure. [Figure 58] FIG. 10 is a perspective view of a rotation assembly of the knob assembly. [Figure 59] FIG. 59 is a longitudinal cross-sectional view of the rotating assembly of FIG. 58. [Figure 60] FIG. 59 is a perspective, partial cross-sectional view with parts separated of the rotating assembly of FIG. 58. [Figure 61] 1 is a perspective view of the rotating assembly, illustrating its operation. [Figure 62] FIG. 10 is a rear perspective view of the adapter assembly illustrating the rotation of the rotation assembly and shaft assembly relative to its drive coupling assembly. [Figure 63] FIG. 10 is a rear perspective view of the adapter assembly showing the adapter assembly in its non-rotated position. [Figure 64] FIG. 64 is a cross-sectional view taken along line 64-64 of FIG. 63. [Figure 65] FIG. 64 is a cross-sectional view taken along line 64-64 of FIG. 63, illustrating the rotation of the rotating assembly and shaft assembly relative to the drive coupling assembly. [Figure 66] FIG. 1 is a perspective view, with parts separated, of a reloader according to the present disclosure; [Figure 67] FIG. 67 is a longitudinal cross-sectional view of the assembled reloader of FIG. 66; [Figure 68] FIG. 68 is a perspective view of the electrical connector of the reloader of FIGS. 66 and 67; [Figure 69] FIG. 69 is a cross-sectional view taken along line 69-69 of FIG. 68. [Figure 70] FIG. 70 is a rear perspective view of the reloader of FIGS. 66-69, showing the release ring and retaining ring separated; [Figure 71] FIG. 10 is a longitudinal cross-sectional view showing the reloading portion aligned with and separated from the more distal end of the adapter assembly. [Figure 72]FIG. 10 is a longitudinal cross-sectional view showing the reloading portion aligned with and connected to the more distal end of the adapter assembly. [Figure 73] FIG. 10 is a front perspective view of an anvil assembly of the present disclosure; [Figure 74] FIG. 74 is a rear perspective view of the anvil assembly of FIG. 73; [Figure 75] FIG. 75 is a perspective view, with parts separated, of the anvil assembly of FIGS. 73 and 74; [Figure 76] FIG. 10 is a rear perspective view of the reloading portion and more distal end of the adapter assembly, showing the connection of the irrigation tubing thereto. [Figure 77] FIG. 10 is a rear perspective view of the reloading portion and more distal end of the adapter assembly, showing the irrigation tubing separated therefrom. [Figure 78] FIG. 78 is an enlarged view of the indicated area of ​​detail of FIG. 77; [Figure 79] FIG. 1 is a perspective view of an irrigation tube. [Figure 80] FIG. 80 is an enlarged view of the indicated area of ​​detail of FIG. 79; [Figure 81] FIG. 80 is an enlarged view of the indicated area of ​​detail of FIG. 79; [Figure 82A] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82B] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82C-1] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82C-2] Same as above. [Figure 82D-1] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82D-2] Same as above. [Figure 82E] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82F] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 82G] 2 shows a flowchart of a method for operating the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 83] 2 is a schematic diagram illustrating the travel distance and speed of an anvil assembly and corresponding motor during a clamping sequence performed by the handheld surgical device of FIG. 1 according to an embodiment of the present disclosure. FIG. [Figure 84] 2 is a schematic diagram illustrating the travel distance and speed of a driver and corresponding motor during a stapling sequence performed by the handheld surgical device of FIG. 1 according to an embodiment of the present disclosure. FIG. [Figure 85] 2 is a schematic diagram illustrating the travel distance and speed of a knife assembly and corresponding motor during a cutting sequence performed by the handheld surgical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 86] 2 shows a flowchart of a method for a controlled tissue compression algorithm performed by the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 87A] 2 shows a flowchart of a method for a stapling algorithm executed by the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 87B] 2 shows a flowchart of a method for a stapling algorithm executed by the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 88A] 2 shows a flowchart of a method for a cutting algorithm executed by the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 88B] 2 shows a flowchart of a method for a cutting algorithm executed by the handheld surgical device of FIG. 1 according to one embodiment of the present disclosure. [Figure 89]FIG. 1 is a schematic diagram of a handheld surgical device, an adapter assembly, and a reloader according to an embodiment of the present disclosure; DETAILED DESCRIPTION OF THE INVENTION

[0059] Embodiments of the presently disclosed surgical device, adapter assembly for a surgical device, and / or handle assembly will now be described in detail with reference to the drawings, in which like reference numerals indicate identical or corresponding elements in each of the several views. As used herein, the term "distal" refers to that portion of, or component of, the adapter assembly or surgical device that is farther from the user, while the term "proximal" refers to that portion of, or component of, the adapter assembly or surgical device that is closer to the user.

[0060] A surgical device according to one embodiment of the present disclosure is a handheld surgical device in the form of a powered electromechanical handle assembly configured to selectively attach a plurality of different reloading parts via a plurality of respective adapter assemblies, each of the plurality of adapter assemblies configured for actuation and operation by the powered electromechanical handle assembly.

[0061] The surgical device includes a handle assembly 100 configured for selective connection with an adapter assembly 200, and the adapter assembly 200 is configured for selective connection with a selected reloading portion 400 (of a plurality of reloading portions), the plurality of reloading portions being configured to produce a surgical effect on the patient's tissue.

[0062] 1-11, handle assembly 100 includes a power handle 101 and a shell housing 10 configured to selectively receive and accommodate power handle 101. Shell housing 10 includes a distal half 10a and a proximal half 10b pivotally connected to distal half 10a by a hinge 16 located along the upper ends of distal and proximal halves 10a, 10b. When joined together, distal and proximal halves 10a, 10b define a shell cavity 10c within which power handle 101 is selectively disposed.

[0063] The distal and proximal halves 10 a , 10 b of shell housing 10 are divided along a plane that intersects the longitudinal axis “X” of adapter assembly 200 .

[0064] Each of the distal and proximal halves 10a, 10b of shell housing 10 includes a respective bottom shell portion 12a, 12b and a respective bottom shell portion 14a, 14b. Bottom shell portions 14a, 14b define snap closure features 18 for selectively securing bottom shell portions 14a, 14b to one another and maintaining shell housing 10 in a closed state. Shell housing 10 includes right and left snap closure features 18a for further securing distal and proximal halves 10a, 10b of shell housing 10 to one another.

[0065] Distal half 10a of shell housing 10 defines a connecting portion 20 configured to receive a corresponding drive coupling assembly 210 of adapter assembly 200. Specifically, distal half 10a of shell housing 10 has a recess 20 that receives a portion of drive coupling assembly 210 of adapter assembly 200 when adapter assembly 200 is mated to handle assembly 100.

[0066] Connecting portion 20 of distal half 10a defines a pair of axially extending guide rails 20a, 20b that project radially inward from an inner side thereof. Guide rails 20a, 20b assist in rotationally orienting adapter assembly 200 relative to handle assembly 100 when adapter assembly 200 is mated to handle assembly 100.

[0067] The connecting portion 20 of the distal half 10a defines three openings 22a, 22b, 22c formed in its distal-facing surface and disposed in a common plane or line with one another. The connecting portion 20 of the distal half 10a also defines an elongated slot 24 (for containing a connector 66, see FIG. 3) formed in its distal-facing surface.

[0068] The connecting portion 20 of the distal half 10a further defines a female connecting feature 26 (see FIG. 2) formed thereon. The female connecting feature 26 selectively engages with a male connecting feature of the adapter assembly 200, as described in more detail below.

[0069] Distal half 10a of shell 10 supports a distally facing toggle control button 30. Toggle control button 30 can be actuated in the left, right, up and down directions by applying a corresponding force or depressing force thereto.

[0070] Distal half 10a of shell 10 supports a right pair of control buttons 32a, 32b (see FIG. 3) and a left pair of control buttons 34a, 34b (see FIG. 2). Right control buttons 32a, 32b and left control buttons 34a, 34b can be actuated by applying a corresponding force or a depressing force thereto.

[0071] The proximal half 10b of the shell housing 10 supports a right firing button 36a (see FIG. 3) and a left firing button 36b (see FIG. 2). The right firing button 36a and the left firing button 36b can be actuated by applying a corresponding force or a downward force thereto.

[0072] The distal and proximal halves 10a, 10b of the shell housing 10 are made from polycarbonate and may be clear, transparent, or overmolded.

[0073] 5-11, handle assembly 100 includes an insertion guide 50 configured and shaped to seat on and completely surround distally facing end 10d (FIGS. 3 and 9) of proximal half 10b. Insertion guide 50 includes a body portion 52 defining a central opening therein and a hand / finger grip tab 54 extending from the bottom of body portion 52.

[0074] In use, when the body portion 52 of the insertion guide 50 is seated against the distal-facing end 10d of the proximal half 10b, the central opening of the insertion guide 50 provides access to the shell cavity 10c of the shell housing 10 for insertion of the non-sterile power handle 101 of the handle assembly 100 into the proximal half 10b of the sterile shell housing 10.

[0075] 2-4, the shell housing 10 includes a sterile barrier plate assembly 60 selectively supported in the distal half 10a. Specifically, the sterile barrier plate assembly 60 is disposed within the shell cavity 10c of the shell housing 10 behind the connecting portion 20 of the distal half 10a. The plate assembly 60 includes a plate 62 that rotatably supports three connecting shafts 64a, 64b, and 64c. Each connecting shaft 64a, 64b, and 64c extends from opposite sides of the plate 62 and has a trilobal cross-sectional profile. Each connecting shaft 64a, 64b, and 64c extends through a respective opening 22b, 22c, and 22a in the connecting portion 20 of the distal half 10a when the sterile barrier plate assembly 60 is disposed within the shell cavity 10c of the shell housing 10.

[0076] Plate assembly 60 further includes an electrical connector 66 supported on plate 62. Electrical connector 66 extends from the opposite side of plate 62. Each coupling shaft 64a, 64b, 64c extends through a respective opening 22a, 22b, 22c in connecting portion 20 of distal half 10a of shell housing 10 when sterile barrier plate assembly 60 is disposed within shell cavity 10c of shell housing 10. Electrical connector 66 includes a tip and defines a plurality of contact paths each including an electrical conduit for extending an electrical connection across plate 62.

[0077] When the plate assembly 60 is disposed within the shell cavity 10c of the shell housing 10, the distal ends of the coupling shafts 64a, 64b, 64c and the distal end of the pass-through connector 66 are disposed or positioned within the connecting portion 20 of the distal half 10a of the shell housing 10 and electrically and / or mechanically engage with corresponding features of the adapter assembly 200, as described in more detail below.

[0078] In operation, with a new and / or sterile shell housing 10 in an open configuration (e.g., with distal half 10a separated from proximal half 10b about hinge 16) and with insertion guide 50 in place relative to the distal end 10d of proximal half 10b of shell housing 10, power handle 101 is inserted through the central opening of insertion guide 50 and into shell cavity 10c of shell housing 10. With power handle 101 inserted into shell cavity 10c of shell housing 10, insertion guide 50 is removed from proximal half 10b and distal half 10a is pivoted about hinge 16 to the closed configuration of shell housing 10. In the closed configuration, snap-closure feature 18 of bottom shell portion 14a of distal half 10a engages with snap-closure feature 18 of bottom shell portion 14b of proximal half 10b. Additionally, right and left side snap closure features 18a engage to further maintain the shell housing 10 in a closed configuration.

[0079] In operation, following a surgical procedure, snap closure features 18 on bottom shell portion 14a of distal half 10a are disengaged from snap closure features 18 on bottom shell portion 14b of proximal half 10b, and right and left side snap closure features 18a are disengaged, thereby allowing distal half 10a to pivot away from proximal half 10b about hinge 16 and open shell housing 10. With shell housing 10 open, power handle 101 is removed from shell cavity 10c of shell housing 10 (specifically, from proximal half 10b of shell housing 10), and shell housing 10 is discarded.

[0080] The power handle 101 is then sterilized and cleaned. The power handle 101 should not be submerged in water and should not be disinfected.

[0081] 3-6 and 12-19, handle assembly 100 includes a power handle 101. Power handle 101 includes an inner handle housing 110 having a lower housing portion 104 and an upper housing portion 108 extending from and / or supported on lower housing portion 104. Lower housing portion 104 and upper housing portion 108 are separated into a distal half 110a and a proximal half 110b connectable to distal half 110a by a plurality of fasteners. When joined together, distal and proximal halves 110a, 110b define inner handle housing 110 having an inner housing cavity 110c therein in which power pack core assembly 106 is disposed.

[0082] Power pack core assembly 106 is configured to control various operations of handle assembly 100, as described in further detail below.

[0083] The distal half 110a of the inner handle housing 110 defines a distal opening 111a therein that is configured and adapted to support a control plate 160 of the power pack core assembly 106. When the power handle 101 is disposed within the shell housing 10, the control plate 160 of the power handle 101 abuts against the rear surface of the plate 62 of the sterile barrier plate assembly 60 of the shell housing 10.

[0084] 12 , the distal half 110a of the inner handle housing 110 supports a distal toggle control interface 130 that is operatively aligned with the distal toggle control button 30 of the shell housing 10. In use, when the power handle 101 is disposed within the shell housing 10, actuation of the toggle control button 30 exerts a force on the toggle control interface 130.

[0085] The distal half 110a of the inner handle housing 110 also supports a right pair of control interfaces 132a, 132b and a left pair of control interfaces 134a, 134b. In use, when the power handle 101 is disposed within the shell housing 10, actuation of one of the right pair of control buttons 32a, 32b or the left pair of control buttons 34a, 34b on the distal half 10a of the shell housing 10 exerts a force on a respective one of the right pair of control interfaces 132a, 132b or the left pair of control interfaces 134a, 134b on the distal half 110a of the inner handle housing 110.

[0086] During use, the control button 30 on the distal half 110a of the inner handle housing 110, the right firing button 36a or the left firing button 36b, the right pair of control interfaces 132a, 132b, and the left pair of control interfaces 134a, 134b are inactive or non-functional unless the shell housing 10 is verified.

[0087] The proximal half 110b of the inner handle housing 110 defines a right control opening 136a and a left control opening 136b. In use, when the power handle 101 is disposed within the shell housing 10, actuation of one of the right or left firing buttons 36a, 36b on the proximal half 10b of the shell housing 10 causes the right or left firing button 36a, 36b to extend into and across the right or left control opening 136a, 136b on the proximal half 110b of the inner handle housing 110.

[0088] 12-19, inner handle housing 110 provides a housing in which power pack core assembly 106 is disposed. Power pack core assembly 106 includes a battery circuit 140, a controller circuit board 142, and a rechargeable battery 144 configured to provide power to any of the electrical components of handle assembly 100. Controller circuit board 142 includes a motor controller circuit board 142a, a main controller circuit board 142b, and a first ribbon cable 142c interconnecting motor controller circuit board 142a and main controller circuit board 142b.

[0089] The power pack core assembly 106 further includes a display screen 146 supported on the main controller circuit board 142b. The display screen 146 is viewable through a clear or transparent window 110d (see FIGS. 12 and 17) in the proximal half 110b of the inner handle housing 110.

[0090] The power pack core assembly 106 further includes a first motor 152, a second motor 154, and a third motor 156, each electrically connected to the controller circuit board 142 and the battery 144. The motors 152, 154, and 156 are disposed between the motor controller circuit board 142a and the main controller circuit board 142b. Each motor 152, 154, and 156 includes a respective motor shaft 152a, 154a, and 156a extending therefrom. Each motor shaft 152a, 154a, and 156a has a trilobal cross-sectional profile for transmitting rotational force or torque.

[0091] Each motor 152, 154, 156 is controlled by a respective motor controller. The motor controllers are disposed on motor controller circuit board 142a and are A3930 / 31K motor drivers manufactured by Allegro Microsystems. The A3930 / 31K motor drivers are designed to control three-phase brushless DC (BLDC) motors with N-channel external power MOSFETs, such as motors 152, 154, 156. Each of the motor controllers is coupled to a main controller disposed on main controller circuit board 142b. The main controller is coupled to memory also disposed on main controller circuit board 142b. The main controller is an ARM Cortex M4 processor manufactured by Freescale Semiconductor and includes 1024 kilobytes of internal flash memory. The main controller communicates with the motor controllers through an FPGA, which provides control logic signals (e.g., coast, brake, etc.). The control logic of the motor controller then outputs corresponding energization signals to each of the motors 152, 154, 156 using fixed frequency pulse width modulation (PWM).

[0092] Each motor 152, 154, 156 is supported on the motor bracket 148 such that the motor shaft 152 a, 154 a, 156 a is rotatably disposed within a respective opening in the motor bracket 148. As shown in FIGS. 16 and 19 , the motor bracket 148 rotatably supports three rotatable drive connector sleeves 152 b, 154 b, 156 b that are keyed to the respective motor shafts 152 a, 154 a, 156 a of the motors 152, 154, 156. The drive connector sleeves 152 b, 154 b, 156 b non-rotatably receive the proximal ends of the respective coupling shafts 64 a, 64 b, 64 c of the plate assembly 60 of the shell housing 10 when the power handle 101 is disposed within the shell housing 10. The drive connector sleeves 152b, 154b, 156b are each spring biased away from the respective motors 152, 154, 156.

[0093] Rotation of motor shafts 152 a, 154 a, 156 a by respective motors 152, 154, 156 functions to drive shafts and / or gear components of adapter assembly 200 to perform various operations of handle assembly 100. In particular, motors 152, 154, 156 of power pack core assembly 106 are configured to drive shafts and / or gear components of adapter assembly 200 to selectively extend / retract trocar member 274 of trocar assembly 270 of adapter assembly 200, to open and close reloading portion 400 (when anvil assembly 510 is connected to trocar member 274 of trocar assembly 270), to fire the annular array of staples of reloading portion 400, and to fire annular knife 444 of reloading portion 400.

[0094] The motor bracket 148 also supports an electrical receptacle 149. The electrical receptacle 149 is electrically connected to the main controller circuit board 142b by a second ribbon cable 142d. The electrical receptacle 149 defines a plurality of electrical slots for receiving respective electrical contacts or blades extending from the pass-through connector 66 of the plate assembly 60 of the shell housing 10.

[0095] During use, when the adapter assembly 200 is mated to the handle assembly 100, each of the coupling shafts 64a, 64b, 64c of the plate assembly 60 of the shell 10 of the handle assembly 100 mates with a corresponding rotatable connector sleeve 218, 222, 220 of the adapter assembly 200 (see FIG. 22 ). In this regard, the mating surfaces of the corresponding first coupling connector 64a and first connector sleeve 218, the mating surfaces of the corresponding second coupling shaft 64b and second connector sleeve 222, and the mating surfaces of the corresponding third coupling shaft 64c and third connector sleeve 220 are keyed together, whereby rotation of each of the coupling shafts 64a, 64b, 64c of the handle assembly 100 causes a corresponding rotation of the corresponding connector sleeve 218, 222, 220 of the adapter assembly 200.

[0096] The mating of coupling shafts 64a, 64b, 64c of handle assembly 100 with connector sleeves 218, 222, 220 of adapter assembly 200 allows rotational force to be transmitted independently through each of the three respective connector interfaces. Coupling shafts 64a, 64b, 64c of handle assembly 100 are configured to be independently rotated by respective motors 152, 154, 156.

[0097] Each of the drive shafts 64a, 64b, 64c of the handle assembly 100 has a keyed and / or substantially non-rotatable interface with a respective connector sleeve 218, 220, 222 of the adapter assembly 200, so that when the adapter assembly 200 is coupled to the handle assembly 100, rotational force(s) are selectively transmitted from the motors 152, 154, 156 of the handle assembly 100 to the adapter assembly 200.

[0098] Selective rotation of coupling shaft(s) 64a, 64b, 64c of handle assembly 100 enables handle assembly 100 to selectively actuate different functions of reloader 400. As discussed in more detail below, selective and independent rotation of first coupling shaft 64a of handle assembly 100 corresponds to selective and independent extension / retraction of trocar member 274 of adapter assembly 200 (when anvil assembly 510 is connected to trocar member 274) and / or selective and independent opening and closing of reloader 400. Also, selective and independent rotation of third coupling shaft 64c of handle assembly 100 corresponds to selective and independent firing of the annular array of staples of reloader 400. Additionally, selective and independent rotation of second coupling shaft 64b of handle assembly 100 corresponds to selective and independent firing of annular knives 444 of reloader 400.

[0099] 12-19, the power pack core assembly 106 further includes a switch assembly 170 supported within the distal half 110a of the inner handle housing 110, positioned below and aligned with the toggle control interface 130, the right pair of control interfaces 132a, 132b, and the left pair of control interfaces 134a, 134b. The switch assembly 170 includes a first set of four push button switches 172a-172d arranged around the stem 30a of the toggle control button 30 of the shell housing 10 when the power handle 101 is disposed within the shell housing 10. The switch assembly 170 also includes a second pair of push button switches 174a, 174b disposed below the right pair of control interfaces 132a, 132b in the distal half 110a of the inner handle housing 110 when the power handle 101 is disposed within the shell housing 10. The switch assembly 170 further includes a third pair of push button switches 176a, 176b disposed below the left pair of control interfaces 134a, 134b in the distal half 110a of the inner handle housing 110 when the power handle 101 is disposed within the outer shell housing 10.

[0100] The power pack core assembly 106 includes a single right push button switch 178a disposed beneath the right control opening 136a in the proximal half 110b of the inner handle housing 110 and a single left push button switch 178b disposed beneath the left control opening 136b in the proximal half 110b of the inner handle housing 110. The push button switches 178a, 178b are supported on the controller circuit board 142. The push button switches 178a, 178b are disposed beneath the right and left firing buttons 36a, 36b in the proximal half 10b of the shell housing 10 when the power handle 101 is disposed within the shell housing 10.

[0101] Actuation of push button switch 172c of switch assembly 170 of power handle 101, corresponding to downward actuation of toggle control button 30, causes controller circuit board 142 to provide an appropriate signal to motor 152 to activate and retract trocar member 274 of adapter assembly 200 and / or close handle assembly 100 (e.g., bring anvil assembly 510 closer to reloading section 400).

[0102] Actuation of push button switch 172a of switch assembly 170 of power handle 101, corresponding to upward actuation of toggle control button 30, activates controller circuit board 142, advances trocar member 274 of adapter assembly 200 and / or opens handle assembly 100 (e.g., releases anvil assembly 510 relative to reloading section 400).

[0103] Actuation of the firing switch 178a or 178b on the power handle 101, corresponding to actuation of the right or left control button 36a, 36b, causes the controller circuit board 142 to provide appropriate signals to activate the motors 154 and 156, as appropriate, to fire the staples in the reloader 400 and in turn advance (e.g., fire) and retract the annular knife 444 in the reloader 400.

[0104] Actuation of switches 174a, 174b (by the user's right thumb) or 176a, 176b (by the user's left thumb) of switch assembly 170, corresponding to actuation of right-side pair of control buttons 32a, 32b or left-side pair of control buttons 34a, 34b, respectively, causes controller circuit board 142 to provide an appropriate signal to motor 152 to activate, advance or retract trocar member 274 of adapter assembly 200.

[0105] 12 and 14, the power pack core assembly 106 of the handle assembly 100 includes a USB connector 180 supported on the main controller circuit board 142b of the controller circuit board 142. The USB connector 180 is accessible through the control plate 160 of the power pack core assembly 106. When the power handle 101 is disposed within the outer shell housing 10, the USB connector 180 is covered by the plate 62 of the sterile barrier plate assembly 60 of the shell housing 10.

[0106] As shown in FIGS. 1 and 20-65, handle assembly 100 is configured for selective connection with adapter assembly 200, and adapter assembly 200 is configured for selective connection with reloader 400.

[0107] The adapter assembly 200 is configured, as shown in FIG. 22 and described in more detail below, to convert rotation of the connecting shaft(s) 64a, 64b, 64c of the handle assembly 100 into axial translation useful for advancing / retracting the trocar member 274 of the adapter assembly 200, for opening and closing the handle assembly 100 (when the anvil assembly 510 is connected to the trocar member 274), for firing the staples of the reloading portion 400, and for firing the annular knife 444 of the reloading portion 400.

[0108] The adapter assembly 200 includes a first drive transmission / conversion assembly for interconnecting the first connecting shaft 64a of the handle assembly 100 and the anvil assembly 510, the first drive transmission / conversion assembly converts and transmits rotation of the first connecting shaft 64a of the handle assembly 100 into axial translation of the trocar member 274 of the trocar assembly 270, and the anvil assembly 510 connected to the trocar member 274 opens and closes the handle assembly 100.

[0109] The adapter assembly 200 includes a second drive transmission / conversion assembly for interconnecting the third connecting shaft 64c of the handle assembly 100 and the second axially translatable drive member of the reloading section 400, the second drive transmission / conversion assembly converting and transmitting rotation of the third connecting shaft 64c of the handle assembly 100 into axial translation of the outer flexible band assembly 255 of the adapter assembly 200, and the driver adapter 432 of the staple driver assembly 430 of the reloading section 400 firing staples from the staple cartridge 420 of the reloading section 400 against the anvil assembly 510.

[0110] The adapter assembly 200 includes a third drive transmission / conversion assembly for interconnecting the second connecting shaft 64b of the handle assembly 100 and the third axially translatable drive member of the reloading section 400, the third drive transmission / conversion assembly converting and transmitting rotation of the second connecting shaft 64b of the handle assembly 100 into axial translation of the internal flexible band assembly 265 of the adapter assembly 200, and the knife assembly 440 of the reloading section 400 firing the annular knife 444 against the anvil assembly 510.

[0111] 20-24 , adapter assembly 200 includes an outer knob housing 202 and an outer tube 206 extending from a distal end of knob housing 202. Knob housing 202 and outer tube 206 are configured and dimensioned to accommodate the components of adapter assembly 200. Knob housing 202 includes a drive coupling assembly 210 configured and adapted to connect to connecting portion 108 of handle housing 102 of handle assembly 100.

[0112] The adapter assembly 200 is configured to convert rotation of any of the first, second or third coupling shafts 64a, 64b, 64c, respectively, of the handle assembly 100 into axial translation useful for operating the trocar assembly 270, the anvil assembly 510, and / or the staple driver assembly 430 or the knife assembly 440 of the reloading portion 400, as described in more detail below.

[0113] 57-61 , adapter assembly 200 includes a proximal inner housing member 204 disposed within knob housing 202. Inner housing member 204 rotatably supports first, second, and third rotatable proximal drive shafts 212, 214, and 216 therein. Each proximal drive shaft 212, 214, and 216 functions as a rotation receiving member for receiving rotational force from a respective coupling shaft 64a, 64c, and 64b of handle assembly 100, as described in more detail below.

[0114] As briefly described above, drive coupling assembly 210 of adapter assembly 200 is also configured to rotatably support first, second, and third connector sleeves 218, 222, and 220, respectively, that are disposed in a common plane or line with one another. Each of connector sleeves 218, 220, 222 is configured to mate with respective first, second, and third coupling shafts 64a, 64c, and 64b of handle assembly 100, as described above. Each of connector sleeves 218, 220, 222 is further configured to mate with the proximal end of respective first, second, and third proximal drive shafts 212, 214, 216 of adapter assembly 200.

[0115] Drive coupling assembly 210 of adapter assembly 200 also includes first, second, and third biasing members 224, 226, and 228 disposed distally of respective first, second, and third connector sleeves 218, 222, 220, as shown in FIGS. 26, 34, 35, and 40. Each of biasing members 224, 226, and 228 is disposed about respective first, second, and third rotatable proximal drive shafts 212, 216, and 214. Biasing members 224, 226, and 228 act on respective connector sleeves 218, 222, and 220 to help maintain connector sleeves 218, 222, and 220 in engagement with the distal ends of respective coupling shafts 64a, 64b, and 64c of handle assembly 100 when adapter assembly 200 is connected to handle assembly 100.

[0116] In particular, first, second, and third biasing members 224, 226, and 228 function to proximally bias respective connector sleeves 218, 222, and 220. In this manner, while connecting handle assembly 100 to adapter assembly 200, when first, second, and / or third connector sleeves 218, 222, and / or 220 are misaligned with coupling shafts 64a, 64b, and 64c of handle assembly 100, first, second, and / or third biasing member(s) 224, 226, and / or 228 are compressed. Thus, when the handle assembly 100 is operated, the coupling shafts 64a, 64c, and 64b of the handle assembly 100 rotate, causing the first, second, and / or third biasing member(s) 224, 228, and / or 226 to slide back the respective first, second, and / or third connector sleeve(s) 218, 220, and / or 222 proximally, effectively connecting the coupling shafts 64a, 64c, and 64b of the handle assembly 100 to the first, second, and / or third proximal drive shaft(s) 212, 214, and 216 of the drive coupling assembly 210.

[0117] As briefly mentioned above, adapter assembly 200 includes first, second, and third force / rotation transmission / conversion assemblies 240, 250, 260 disposed within inner housing member 204 and outer tube 206, respectively. Each force / rotation transmission / conversion assembly 240, 250, 260 is configured and adapted to transmit or convert rotation of first, second, and third coupling shafts 64a, 64c, and 64b of handle assembly 100 into axial translation to effect operation of trocar assembly 270 of adapter assembly 200 and staple driver assembly 430 or knife assembly 440 of reloader 400.

[0118] 25-28 , first force / rotation transmission / conversion assembly 240 includes first rotatable proximal drive shaft 212, second rotatable proximal drive shaft 281, rotatable distal drive shaft 282, and coupling member 286, as described above, each of which is supported within inner housing member 204, drive coupling assembly 210, and / or outer tube 206 of adapter assembly 200. First force / rotation transmission / conversion assembly 240 functions to extend / retract trocar member 274 of trocar assembly 270 of adapter assembly 200, and to open and close handle assembly 100 (when anvil assembly 510 is connected to trocar member 274).

[0119] The first rotatable proximal drive shaft 212 includes a non-circular or shaped proximal end portion configured to connect with a first connector 218 connected to each first coupling shaft 64a of the handle assembly 100. The first rotatable proximal drive shaft 212 includes a non-circular recess formed therein that is configured to key with a respective complementarily shaped proximal end 281a of the second rotatable proximal drive shaft 281. The second rotatable proximal drive shaft 281 includes a distal end portion 281b defining an oversized recess therein that is configured to receive the proximal end portion 282a of the first rotatable distal drive shaft 282. The proximal end portion 282a of the first rotatable distal drive shaft 282 is pivotally fixed within a recess in the distal end 281b of the second rotatable proximal drive shaft 281 by a pin 283a received through an oversized recess in the distal end portion 281b of the second rotatable proximal drive shaft 281.

[0120] The first rotatable distal drive shaft 282 includes a proximal end portion 282a and a distal end portion 282b pivotally secured within a recess in the coupling member 286. The distal end portion 282b of the first rotatable distal drive shaft 282 is pivotally secured within a recess in the proximal end of the coupling member 286 by a pin 283b received through a recess in the proximal end portion of the coupling member 286. The proximal and distal end portions 282a, 282b of the first rotatable distal drive shaft 282 define oversized openings for receiving the pins 283a, 283b, respectively.

[0121] The coupling member 286 includes a proximal end 286a defining a recess 286c for receiving the distal end portion 282b of the first rotatable distal drive shaft 282, and a distal end 286b defining a recess 286d for operably receiving the non-circular stem 276c on the proximal end 276a of the drive screw 276 of the trocar assembly 270.

[0122] First force / rotation transmission / conversion assembly 240 further includes a trocar assembly 270 removably supported on the distal end of outer tube 206. Trocar assembly 270 includes a tubular outer housing 272, a trocar member 274 slidably disposed within tubular outer housing 272, and a drive screw 276 operably received within trocar member 274 for axially moving trocar member 274 relative to tubular housing 272. In particular, trocar member 274 includes a proximal end 274a having an internally threaded portion that engages with a threaded distal portion 276b of drive screw 276. Trocar member 274 further includes at least one longitudinally extending flat formed on its outer surface that mates with a corresponding flat formed within tubular housing 272, thereby preventing rotation of trocar member 274 relative to tubular housing 272 when drive screw 276 is rotated. Distal end 274b of trocar member 274 is configured to selectively engage anvil assembly 510 (FIGS. 73-75).

[0123] The tubular housing 272 of the trocar assembly 270 is axially and rotationally fixed within the outer tube 206 of the adapter assembly 200. The tubular housing 272 defines a pair of radially opposed and radially oriented openings 272a configured and dimensioned to cooperate with a pair of locking pins 275c of the trocar assembly release mechanism 275. With reference to FIGS. 29-33 , the adapter assembly 200 includes a support block 292 fixedly disposed within the outer tube 206. As described in more detail below, the support block 292 is positioned proximal to the connector sleeve 290 and proximal to the strain sensor 320a of the strain gauge assembly 320. The pair of locking pins 275c extend through the support block 292 into the tubular housing 272 of the trocar assembly 270 to connect the trocar assembly 270 to the adapter assembly 200.

[0124] As shown in FIGS. 29-33, the trocar assembly release mechanism 275 includes a release button 275a pivotally supported on the support block 292 and within the outer tube 206. The release button 275a is spring-biased to a locked / extended state. The trocar assembly release mechanism 275 further includes a spring clip 275b connected to the release button 275a, the spring clip 275b including a pair of legs that extend through the support block 292 and across the trocar assembly 270. Each of the pair of legs of the spring clip 275b extends through a respective radial opening 272a in the tubular housing 272 and a respective locking pin 275c slidably disposed within the radial opening 292a in the support block 292 (see FIG. 31).

[0125] During use, when release button 275a is depressed (e.g., radially inward, FIG. 33 ), release button 275a moves spring clip 275b laterally relative to trocar assembly 270. As spring clip 275b is moved laterally relative to trocar assembly 270, the pair of legs of spring clip 275b translate through the pair of locking pins 275c such that the gooseneck of each leg acts to cam and urge the pair of locking pins 275c radially outward. Each of the pair of locking pins 275c is urged radially outward a sufficient distance to pass through a respective opening 272a in tubular housing 272. Once the pair of locking pins 275c are free to separate from tubular housing 272, trocar assembly 270 can be axially withdrawn from within the distal end of outer tube 206 of adapter assembly 200.

[0126] In operation, rotation of the first rotatable proximal drive shaft 212, due to rotation of the first connector sleeve 218, causes rotation of the second rotatable distal drive shaft 281 as a result of rotation of the first coupling shaft 64a of the handle assembly 100. Rotation of the second rotatable distal drive shaft 281 results in simultaneous rotation of the first rotatable distal drive shaft 282. Rotation of the first rotatable distal drive shaft 282 causes simultaneous rotation of the coupling member 286, which in turn causes simultaneous rotation of the drive screw 276 of the trocar assembly 270. As the drive screw 276 rotates within and relative to the trocar member 274, engagement of the internally threaded portion of the trocar member 274 with the threaded distal portion 276b of the drive screw 276 causes axial translation of the trocar member 274 within the tubular housing 272 of the trocar assembly 270. Specifically, rotation of the drive screw 276 in a first direction causes axial translation of the trocar member 274 in the first direction (e.g., extension of the trocar assembly 270 of the handle assembly 100), and rotation of the drive screw 276 in a second direction causes axial translation of the trocar member 274 in the second direction (e.g., retraction of the trocar assembly 270 of the handle assembly 100).

[0127] When the anvil assembly 510 is connected to the trocar member 274, axial translation of the trocar member 274 in a first direction causes the reloading portion 400 to open, and axial translation of the trocar member 274 in a second direction causes the reloading portion 400 to close, as described in detail below.

[0128] The force during closure of the actuation or trocar member 274 or reloading portion 400 can be measured by strain sensor 320a of strain gauge assembly 320 to: - Determine the presence and proper engagement of the trocar assembly 270 in the adapter assembly 200. - Determines the presence of the anvil assembly 510 during calibration. - Determine misalignment of the splines of the trocar member 274 with the longitudinally extending ridges 416 of the reloading portion 400. - Determine retightening of a previously tiled anvil assembly 510. - Determine the presence of an obstruction during tightening or closing of the reloader 400. - Determine the presence of the anvil assembly 510 and its connection with the trocar member 274. - Monitor and control the compression of tissue disposed within the reloader 400. - Monitoring the relaxation of tissue clamped within the reloader 400 over time. - Monitors and controls the firing of staples from the reloader 400. - Detect the presence of staples in the reloader 400. - Monitoring the force during firing and formation of the staples as they are ejected from the reloader 400. - Optimizing staple formation (e.g., staple crimp height) as staples are being ejected from the reloader 400 for different tissue indications. - Monitoring and controlling the firing of the annular knife 444 of the reloader 400. -Monitoring and controlling the completion of launch and disconnection procedures. -Monitor maximum firing force and control firing and disconnection procedures to protect against exceeding the predetermined maximum firing force.

[0129] During operation, strain sensor 320a of strain gauge assembly 320 of adapter assembly 200 measures and monitors retraction of trocar member 274, as described above. When head assembly 512 of anvil assembly 510 contacts tissue, an obstruction, staple cartridge 420, or the like during closure of reloader 400, a reaction force generally in the distal direction is exerted on head assembly 512. This distally directed reaction force is transmitted from head assembly 512 to central rod assembly 514 of anvil assembly 510 and thence to trocar assembly 270. Trocar assembly 270 then transmits the distally directed reaction force to pair of pins 275c of trocar assembly release mechanism 275, which then transmits the reaction force to support block 292. Support block 292 then transmits the distally directed reaction force to strain sensor 320a of strain gauge assembly 320.

[0130] The strain sensor 320a of the strain gauge assembly 320 is a device configured to measure the strain (a dimensionless quantity) of the object to which it is attached (e.g., the support block 292); when the object deforms, the metal foil of the strain sensor 320a also deforms, changing its electrical resistance; the change in resistance is then used to calculate the load experienced by the trocar assembly 270.

[0131] The strain sensors 320a of the strain gauge assembly 320 then communicate signals to the main controller circuit board 142b of the power pack core assembly 106 of the handle assembly 100. A graphic is then displayed on the display screen 146 of the power pack core assembly 106 of the handle assembly 100 to provide the user with real-time information related to the firing status of the handle assembly 100.

[0132] 34-38 , second force / rotation transmission / conversion assembly 250 of adapter assembly 200 includes, as described above, second proximal drive shaft 214, first coupling shaft 251, planetary gear set 252, staple lead screw 253, and staple driver 254, each of which is supported within inner housing member 204, drive coupling assembly 210, and / or outer tube 206 of adapter assembly 200. Second force / rotation transmission / conversion assembly 250 functions to fire the staples of reload portion 400 for formation against anvil assembly 510.

[0133] The second rotatable proximal drive shaft 214 includes a non-circular or shaped proximal end portion configured to connect with a second connector or coupler 220 connected to each second coupling shaft 64c of the handle assembly 100. The second rotatable proximal drive shaft 214 further includes a distal end portion 214b having a spur gear non-rotatably connected thereto.

[0134] The first coupling shaft 251 of the second force / rotation transmission / conversion assembly 250 includes a proximal end portion 251 a having a spur gear non-rotatably connected thereto and a distal end portion 251 b having a spur gear non-rotatably connected thereto. The spur gear at the proximal end portion 251 a of the first coupling shaft 251 meshingly engages with the spur gear at the distal end portion 214 b of the second rotatable proximal drive shaft 214.

[0135] Planetary gear set 252 of second force / rotation transmission / conversion assembly 250 includes first cannulated sun gear 252a, first set of planetary gears 252b, ring gear 252c, second set of planetary gears 252d, and second cannulated sun gear 252e. First sun gear 252a meshes with a spur gear at distal end portion 251b of first connecting shaft 251. First set of planetary gears 252b is positioned between and meshes with first sun gear 252a and ring gear 252c. Second set of planetary gears 252d is positioned between and meshes with second sun gear 252e and ring gear 252c. Ring gear 252c is non-rotatably supported in outer tube 206 of adapter assembly 200.

[0136] The planetary gear set 252 of the second force / rotation transmission / conversion assembly 250 includes a washer 252f disposed within the ring gear 252c and between the first set of planetary gears 252b and the second set of planetary gears 252d. The first set of planetary gears 252b is radially rotatably supported around the washer 252f, and the second sun gear 252e is non-rotatably connected to the center of the washer 252f.

[0137] The staple lead screw 253 of the second force / rotation transmission / conversion assembly 250 includes a proximal flange 253a and a distal threaded portion 253b extending from the flange 253a. The staple lead screw 253 defines a lumen 253c therethrough. A second set of planetary gears 252d is radially rotatably supported about the proximal flange 253a of the staple lead screw 253.

[0138] Staple driver 254 of second force / rotation transmission / conversion assembly 250 includes a central threaded lumen 254a extending therethrough and is configured and dimensioned to support distal threaded portion 253b of staple lead screw 253 therein. Staple driver 254 includes a pair of tabs 254b projecting radially from its outer surface and configured to connect to outer flexible band assembly 255 of adapter assembly 200, as described in more detail below.

[0139] 34, 35, and 43-51, second force / rotation transmission / conversion assembly 250 of adapter assembly 200 includes an outer flexible band assembly 255 secured to staple driver 254. Outer flexible band assembly 255 includes first and second flexible bands 255a, 255b connected at a proximal end thereof to a support ring 255c and at a distal end thereof to the proximal end of a support base 255d in laterally spaced apart relation. Each of first and second flexible bands 255a, 255b is attached to support ring 255c and support base 255d.

[0140] The outer flexible band assembly 255 further includes first and second connecting extensions 255e, 255f extending proximally from the support ring 255c. The first and second connecting extensions 255e, 255f are configured to operably connect the outer flexible band assembly 255 to the staple driver 254 of the second force / rotation transmission / conversion assembly 250. In particular, the first and second connecting extensions 255e, 255f each define an opening configured to receive a respective tab 254b of the staple driver 254. Reception of the tab 254b of the staple driver 254 in the opening of the respective first and second connecting extensions 255e, 255f secures the outer flexible band assembly 255 to the staple driver 254 of the second force / rotation transmission / conversion assembly 250.

[0141] Support base 255 d extends distally from flexible bands 255 a , 255 b and is configured to selectively contact driver adapter 432 of staple driver assembly 430 of reloader 400 .

[0142] The flexible bands 255a, 255b are fabricated from semi-hard stainless steel 301 and are configured to transmit an axial compressive force along a curved path.

[0143] Second force / rotation transmission / conversion assembly 250 and outer flexible band assembly 255 are configured to receive first rotatable proximal drive shaft 212, first rotatable distal drive shaft 282, and trocar assembly 270 of first force / rotation transmission / conversion assembly 240 therethrough. Specifically, first rotatable proximal drive shaft 212 is non-rotatably connected to second rotatable proximal drive shaft 281, which is rotatably disposed within and through first cannulated sun gear 252a of first planetary gear set 252, second cannulated sun gear 252e of planetary gear set 252, staple lead screw 253, and staple driver 254.

[0144] Second force / rotation transmission / conversion assembly 250 and outer flexible band assembly 255 are also configured to receive therethrough third force / rotation transmission / conversion assembly 260. Specifically, inner flexible band assembly 265 is slidably disposed within and through outer flexible band assembly 255, as described below.

[0145] The first rotatable distal drive shaft 282 of the first force / rotation transmission / conversion assembly 240 is rotatably disposed within the support base 255d of the outer flexible band assembly 255, while the trocar member 274 of the trocar assembly 270 of the first force / rotation transmission / conversion assembly 240 is slidably disposed within the support base 255d of the outer flexible band assembly 255.

[0146] The outer flexible band assembly 255 is also configured to receive the inner flexible band assembly 265 therethrough.

[0147] In operation, rotation of second rotatable proximal drive shaft 214, resulting from rotation of second connector sleeve 220 as a result of rotation of second connector shaft 64c of handle assembly 100, causes rotation of first connector shaft 251, which in turn causes rotation of first planetary gear 252a. Rotation of first cannulated sun gear 252a causes simultaneous rotation of first set of planetary gears 252b, which in turn causes washer 252f to simultaneously rotate second cannulated sun gear 252e. Rotation of second cannulated sun gear 252e causes simultaneous rotation of second set of planetary gears 252d, which in turn causes simultaneous rotation of staple lead screw 253. Rotation of staple lead screw 253 causes axial translation of staple driver 254, which in turn causes axial translation of outer flexible band assembly 255. As the outer flexible band assembly 255 translates axially, the support base 255d pushes against the driver adapter 432 of the staple driver assembly 430 of the reloader 400, advancing the driver 434 distally and firing the staples "S" (FIG. 67) of the reloader 400 against the anvil assembly 510 for the formation of the staples "S" in the underlying tissue.

[0148] 39-42 and 45-51 , third force / rotation transmission / conversion assembly 260 of adapter assembly 200 includes, as described above, third proximal drive shaft 216, second coupling shaft 261, planetary gear set 262, knife lead screw 263, and knife driver 264, each of which is supported within inner housing member 204, drive coupling assembly 210, and / or outer tube 206 of adapter assembly 200. Third force / rotation transmission / conversion assembly 260 functions to fire the knife of reloader 400.

[0149] The third rotatable proximal drive shaft 216 includes a non-circular or shaped proximal end portion configured to connect with a third connector or coupler 222 connected to each third coupling shaft 64b of the handle assembly 100. The third rotatable proximal drive shaft 216 further includes a distal end portion 216b having a spur gear non-rotatably connected thereto.

[0150] The second coupling shaft 261 of the third force / rotation transmission / conversion assembly 260 includes a proximal end portion 261 a having a spur gear non-rotatably connected thereto and a distal end portion 261 b having a spur gear non-rotatably connected thereto. The spur gear at the proximal end portion 261 a of the second coupling shaft 261 meshingly engages with the spur gear at the distal end portion 216 b of the third rotatable proximal drive shaft 216.

[0151] The planetary gear set 262 of the third force / rotation transmission / conversion assembly 260 includes a first cannulated sun gear 262a, a first set of planet gears 262b, a ring gear 262c, a second set of planet gears 262d, and a second cannulated sun gear 262e. The first sun gear 262a is non-rotatably supported on the distal end portion of a hollow shaft 269. The hollow shaft 269 includes a spur gear 269a non-rotatably supported on its proximal end. The spur gear 269a of the hollow shaft 269 meshes with the spur gear at the distal end portion 261b of the second coupling shaft 261. The first set of planet gears 262b is positioned between and meshes with the first sun gear 262a and the ring gear 262c. A second set of planet gears 262d is positioned between and meshes with the second sun gear 262e and the ring gear 262c, which is non-rotatably supported in the outer tube 206 of the adapter assembly 200.

[0152] The planetary gear set 262 of the third force / rotation transmission / conversion assembly 260 includes a washer 262f disposed within the ring gear 262c and between the first set of planetary gears 262b and the second set of planetary gears 262d. The first set of planetary gears 262b is radially rotatably supported around the washer 262f, and the second sun gear 262e is non-rotatably connected to the center of the washer 262f.

[0153] The staple lead screw 263 of the second force / rotation transmission / conversion assembly 260 includes a proximal flange 263a and a distal threaded portion 263b extending from the flange 263a. The knife lead screw 263 defines a lumen 263c therethrough. A second set of planet gears 262d is radially rotatably supported about the proximal flange 263a of the knife lead screw 263.

[0154] Knife driver 264 of second force / rotation transmission / conversion assembly 260 includes a central threaded lumen 264a extending therethrough and is configured and dimensioned to support distal threaded portion 263b of knife lead screw 263 therein. Staple driver 264 includes a pair of tabs 264b projecting radially from its outer surface and configured to connect to inner flexible band assembly 265 of adapter assembly 200, as described in more detail below.

[0155] 39-42, third force / rotation transmission / conversion assembly 260 of adapter assembly 200 includes an internal flexible band assembly 265 secured to knife driver 264. Internal flexible band assembly 265 includes first and second flexible bands 265a, 265b connected at a proximal end thereof to a support ring 265c and at a distal end thereof to the proximal end of a support base 265d in laterally spaced-apart relation. Each of first and second flexible bands 265a, 265b is attached to support ring 265c and support base 265d. Internal flexible band assembly 265 is configured to receive first rotatable proximal drive shaft 212, first rotatable distal drive shaft 282, and trocar assembly 270 of first force / rotation transmission / conversion assembly 240 therethrough.

[0156] The inner flexible band assembly 265 further includes first and second connecting extensions 265e, 265f extending proximally from the support ring 265c. The first and second connecting extensions 265e, 265f are configured to operably connect the inner flexible band assembly 265 to the knife driver 264 of the third force / rotation transmission / conversion assembly 260. In particular, the first and second connecting extensions 265e, 265f each define an opening configured to receive a respective tab 264b of the knife driver 264. Reception of the tab 264b of the knife driver 264 in the opening of the respective first and second connecting extensions 265e, 265f secures the inner flexible band assembly 265 to the knife driver 264 of the third force / rotation transmission / conversion assembly 260.

[0157] Support base 265 d extends distally from flexible bands 265 a , 265 b and is configured to connect with knife carrier 442 of knife assembly 440 of reloader 400 .

[0158] The flexible bands 265a, 265b are fabricated from semi-hard stainless steel 301 and are configured to transmit an axial compressive force along a curved path.

[0159] Third force / rotation transmission / conversion assembly 260 and inner flexible band assembly 265 are configured to receive first rotatable proximal drive shaft 212, first rotatable distal drive shaft 282, and therethrough trocar assembly 270 of first force / rotation transmission / conversion assembly 240. Specifically, first rotatable proximal drive shaft 212 is rotatably disposed within and through hollow shaft 269, first cannulated sun gear 262a of first planetary gear set 262, second cannulated sun gear 262e of planetary gear set 262, knife lead screw 263, and knife driver 264.

[0160] The first rotatable distal drive shaft 282 of the first force / rotation transmission / conversion assembly 240 is also rotatably disposed within the support base 265d of the outer flexible band assembly 265, while the trocar member 274 of the trocar assembly 270 of the first force / rotation transmission / conversion assembly 240 is slidably disposed within the support base 265d of the inner flexible band assembly 265.

[0161] In operation, rotation of the third rotatable proximal drive shaft 216, resulting from rotation of the third connector sleeve 222 as a result of rotation of the third coupling shaft 64b of the handle assembly 100, causes rotation of the second coupling shaft 261, which in turn causes rotation of the hollow shaft 269. Rotation of the hollow shaft 269 causes simultaneous rotation of the first set of planetary gears 262b, which in turn causes washer 262f to rotate the second cannulation sun gear 262e. Rotation of the second cannulation sun gear 262e causes simultaneous rotation of the second set of planetary gears 262d, which in turn rotates the knife lead screw 263. Rotation of the knife lead screw 263 causes axial translation of the knife driver 264, which in turn causes axial translation of the inner flexible band assembly 265. As the internal flexible band assembly 265 translates axially, the support base 265d pushes against the knife carrier 442 of the reloading unit 400, advancing the knife carrier 442 distally and firing the annular knife 444 of the reloading unit 400 against the anvil assembly 510 to cut the tissue clamped to the reloading unit 400.

[0162] 21-24 , adapter assembly 200 includes an outer tube 206 extending from knob housing 202. As described above, outer tube 206 is configured to support first, second, and third force / rotation transmitting / converting assemblies 240, 250, 260, respectively. Adapter assembly 200 further includes a frame assembly 230 supported within outer tube 206. Frame assembly 230 is configured to support and guide flexible bands 255 a, 255 b of outer flexible band assembly 255 and flexible bands 265 a, 265 b of inner flexible band assembly 265 as flexible bands 255 a, 255 b, 265 a, 265 b axially translate through outer tube 206.

[0163] Frame assembly 230 includes first and second proximal spacer members 232 a, 232 b and first and second distal spacer members 234 a, 234 b. When secured together, first and second proximal spacer members 232 a, 232 b define a pair of interior longitudinal slots 234 c for slidably receiving first and second flexible bands 265 a, 265 b of interior flexible band assembly 265 and a pair of exterior longitudinal slots 234 d for slidably receiving first and second flexible bands 255 a, 255 b of exterior flexible band assembly 255. The first and second proximal spacer members 232a, 232b further define longitudinal passages therethrough for receiving the first force / rotation transmission / conversion assembly 240 and the trocar assembly 270.

[0164] First and second distal spacer members 234a, 234b define a pair of internal slots 234c for slidably receiving first and second flexible bands 265a, 265b of inner flexible band assembly 265, and a pair of internal slots 234d for slidably receiving first and second flexible bands 255a, 255b of outer flexible band assembly 255. First and second distal spacer members 234a, 234b further define longitudinal passages therethrough for receiving first force / rotation transmission / conversion assembly 240 and trocar assembly 270.

[0165] The first and second proximal spacer members 232a, 232b and the first and second distal spacer members 234a, 234b are formed of plastic to reduce friction with the flexible bands 255a, 255b of the outer flexible band assembly 255 and the flexible bands 265a, 265b of the inner flexible band assembly 265.

[0166] 44-50 , frame assembly 230 further includes seal member 235. Seal member 235 sealingly engages outer tube 206, inner and outer flexible bands 255 a, 255 b and 265 a, 265 b of respective inner and outer flexible band assemblies 255, 265, trocar assembly 270, and the wiring extending therethrough. In this manner, seal member 235 operates to provide a fluid-tight seal between the distal and proximal ends of outer tube 206.

[0167] The adapter assembly 200 further includes a connector sleeve 290 fixedly supported at the distal end of the outer tube 206. The connector sleeve 290 is configured to selectively secure a fixed reload member 400 to the adapter assembly 200, as described in more detail below. The connector sleeve 290 is also configured to be disposed about the distal end of the outer and inner flexible assemblies 255, 265 and the trocar assembly 270. In particular, the proximal end of the connector sleeve 290 is configured to be received within and securely mounted to the distal end of the outer tube 206 and to engage with the dye gauge assembly 320 of the adapter assembly 200, and the distal end of the connector sleeve 290 is configured to selectively engage with the proximal end of the reload member 400.

[0168] 52-55, 60, and 69, adapter assembly 200 includes an electrical assembly 310 disposed within adapter assembly 200 and configured for electrical connection with and between handle assembly 100 and reloader 400. Electrical assembly 310 functions to enable calibration and communication information (e.g., identification information, life cycle information, system information, force information) to main controller circuit board 142b of power pack core assembly 106 via electrical receptacle 149 of power pack core assembly 106 of handle assembly 100.

[0169] The electrical assembly 310 includes a proximal pin connector assembly 312 , a proximal harness assembly 314 in the form of a ribbon cable, a distal harness assembly 316 in the form of a ribbon cable, a strain gauge assembly 320 , and a distal electrical connector 322 .

[0170] A proximal pin connector assembly 312 of the electrical assembly 310 is supported within the inner housing member 204 of the knob housing 202 and the drive coupling assembly 210. The proximal pin connector assembly 312 is supported on a circuit board 312b and includes a plurality of electrical contact blades 312a that enable electrical connection to the pass-through connector 66 of the plate assembly 60 of the outer shell housing 10 of the handle assembly 100. A proximal harness assembly 314 is electrically connected to the circuit board 312b of the proximal pin connector assembly 312 ( FIGS. 53 and 54 ).

[0171] Strain gauge assembly 320 is electrically connected to proximal pin connector assembly 312 via proximal and distal harness assemblies 314, 316. Strain gauge assembly 320 includes a strain sensor 320a supported on outer tube 206 of adapter assembly 200. Strain sensor 320a is electrically connected to distal harness assembly 316 via sensor flex cable 320b. Strain sensor 320a defines a lumen therethrough, through which trocar assembly 270 extends.

[0172] 29-33, the trocar assembly 270 of the first force / rotation transmission / conversion assembly 240 extends through the strain sensor 320a of the strain gauge assembly 320. The strain gauge assembly 320 provides closed-loop feedback on the firing / clamping loads presented by the first, second, and third force / rotation transmission / conversion assemblies 240, 250, 260, respectively.

[0173] Strain sensor 320a of strain gauge assembly 320 is supported within outer tube 206 and is positioned between connector sleeve 290 and support block 292. Support block 292 includes a raised ledge 292b (see FIG. 29) extending distally therefrom that contacts strain sensor 320a.

[0174] 53-55, electrical assembly 310 includes a distal electrical connector 322 supported within connector sleeve 290, as described above. Distal electrical connector 322 is configured to selectively mechanically and electrically connect to tip assembly 460 of reload unit 400 when reload unit 400 is connected to adapter assembly 200.

[0175] Distal electrical connector 322 includes plug member 322a, first and second wires 323a, 323b, and first and second contact members 324a, 324b electrically connected to the respective first and second wires 323a, 323b. Plug member 322a includes a pair of arms 322b, 322c that support first and second contact members 324a, 324b, respectively. The pair of arms 322b, 322c are sized and dimensioned to be received within cavity 461a of tip assembly 460 and around circuit board assembly 464 of reload unit 400 when reload unit 400 is connected to adapter assembly 200.

[0176] When the reloading unit 400 is connected to the adapter assembly 200, the first and second contact members 324a, 324b of the distal electrical connector 322 are configured to engage with respective contact members 464b of the circuit board assembly 464 of the chip assembly 460 of the reloading unit 400.

[0177] 57-65, adapter assembly 200 includes a rotation assembly 330 configured to enable rotation of adapter assembly 200 relative to handle assembly 100. Specifically, outer knob housing 202 and outer tube 206 of adapter assembly 200 are rotatable relative to drive coupling assembly 210 of adapter assembly 200.

[0178] Rotation assembly 330 includes a lock button 332 operably supported on outer knob housing 202. As described in further detail below, when rotation assembly 330 is in the unlocked configuration, outer knob housing 202 and outer tube 206 are rotatable along the longitudinal axis of adapter assembly 200 relative to drive coupling assembly 210. When rotation assembly 330 is in the locked configuration, knob housing 202 and outer tube 206 are rotationally fixed relative to drive coupling assembly 210. Notably, because outer tube 206 has a curved profile, rotation of outer knob housing 202 and outer tube 206 about the longitudinal axis of adapter assembly 200 positions handle assembly 100 in various orientations relative to adapter assembly 200, providing the clinician with increased flexibility in manipulating surgical instruments at a target surgical site.

[0179] Lock button 332 of rotation assembly 330 is configured to operably engage inner housing member 204 of adapter assembly 200. Inner housing member 204 is a substantially cylindrical member defining a pair of longitudinal openings for receiving at least a portion of first and second force / rotation transmitting / converting assemblies 240, 250 therethrough. Inner housing member 204 includes proximal and distal annular flanges 204a, 204b and further defines proximal and distal outer annular grooves. The proximal annular groove of inner housing member 204 receives the inner annular flange of outer knob housing 202 to rotatably secure outer knob housing 202 to inner housing member 204.

[0180] 57-65, distal annular flange 204b and distal annular groove of inner housing member 204 operate in combination with rotation assembly 330 of adapter assembly 200 to secure outer knob housing 202 in a fixed rotational orientation relative to inner housing member 204. In particular, distal annular flange 204b of inner housing member 204 defines first, second, and third radial notches 204c, 204d, 204e configured to selectively receive lock shoe 334 of lock button 332 of rotation assembly 330. First and third notches 204c, 204e oppose one another, and second notch 204d is oriented perpendicular to first and third notches 204c, 204e.

[0181] 60-61 , outer knob housing 202 has a frustoconical profile including a plurality of ridges configured for operable engagement by a clinician. Outer knob housing 202 defines a radial opening for operably supporting lock button 332. The opening in outer knob housing 202 is positioned in alignment with or in registration with the distal annular groove of inner housing member 204 such that lock button 332 of rotation assembly 330 is receivable in the distal annular groove and selectively receivable within first, second, and third notches 204c, 204d, 204e in distal annular flange 204b of inner housing member 204.

[0182] As described above, rotating assembly 330 of adapter assembly 200 includes a lock button 332 operably supported within an opening in outer knob housing 202 and configured to actuate rotating assembly 330. Rotating assembly 330 further includes a lock shoe 334 disposed between outer knob housing 202 and inner housing member 204 and axially slidable relative to lock button 332 and inner housing member 204. A biasing member 336 is interposed between lock button 332 and lock shoe 334 to urge lock button 332 to a locked position, where lock shoe 334 is disposed within one of first, second, and third notches 204c, 204d, 204e in distal annular flange 204b of inner housing member 204.

[0183] The lock button 332 is configured for operable engagement by a clinician. The lock button member 332 defines an angled cam slot 332a formed therein for receiving a cam pin or boss 334a of the lock shoe 334. A biasing member 336 biases the lock button 332 and the lock shoe 334 away from each other, causing the lock shoe 334 to contact the distal annular flange 204b of the inner housing member 204 and press into one of the first, second, and third notches 204c, 204d, and 204e in the distal annular flange 204b when the lock shoe 334 is aligned with one of the first, second, and third notches 204c, 204d, and 204e.

[0184] As described above, lock shoe 334 is configured to be selectively received within one of first, second, and third radial notches 204c, 204d, 204e in distal annular flange 204b of inner housing member 204. Specifically, lock shoe 334 includes or defines a shoulder 334a protruding from a surface thereof for reception within one of first, second, and third radial notches 204c, 204d, 204e in distal annular flange 204b when shoulder 334a of lock shoe 334 is aligned with one of first, second, and third radial notches 204c, 204d, 204e in distal annular flange 204b and lock button 332 is not depressed. When shoulder 334a of lock shoe 334 is disengaged from any of first, second, and third radial notches 204c, 204d, 204e in distal annular flange 204b (e.g., rotating assembly 330 is in an unlocked state), outer knob housing 202 rotates freely relative to inner housing member 204, and therefore adapter assembly 200 rotates freely relative to handle assembly 100.

[0185] Operation of rotation assembly 330 will now be described with continued reference to Figures 57-65. Referring initially to Figures 58, 59, 61, and 64, rotation assembly 330 is shown in a locked state. In particular, in the locked state, shoulder 334a of lock shoe 334 is received within first notch 204c in distal annular flange 204a of inner housing member 204. Also in the locked state, lock button 332 of rotation mechanism 330 is biased radially outward by biasing member 336.

[0186] When the lock button 332 of the rotating assembly 330 is pressed, the lock button 332 moves radially inward against the bias of the biasing member 336, as shown by arrow "A" in FIG. 64 . As the lock button 332 moves radially inward, the lock shoe 334 slides axially distally against the bias of the biasing member 336. The axial sliding of the lock shoe 334 moves the shoulder 334 a of the lock shoe 334 out from within the first radial notch 204 c in the distal annular flange 204 b of the inner housing member 204, thus placing the rotating assembly 330 in an unlocked state and allowing the outer knob housing 202 to freely rotate relative to the inner housing member 204, as shown by arrow "B" in FIG. 62 .

[0187] 65, once the rotation assembly 330 is in the unlocked state, the outer knob housing 202 can be rotated relative to the inner housing member 204. Releasing the lock button 332 allows the biasing member 336 to bias the lock button 332 to its initial position. Similarly, the biasing member 336 biases the lock shoe 334 to its initial position. When the lock shoe 334 is realigned with one of the first, second, and third radial notches 204c, 204d, 204e in the distal annular flange 204b of the inner housing member 204, as the outer knob housing 202 rotates relative to the inner housing member 204, the shoulder 334a of the lock shoe 334 is freely received within the respective first, second, and third notches 204c, 204d, 204e, rotationally locking the outer knob housing 202 relative to the inner housing member 204 and driving the drive coupling assembly 210 of the adapter assembly 200.

[0188] Rotation assembly 330 may be used throughout a surgical procedure to rotate handle assembly 100 and adapter assembly 200 relative to one another.

[0189] During rotation of outer knob housing 202 relative to inner housing member 204 and drive coupling assembly 210 of adapter assembly 200, proximal drive shafts 212, 214, 216 are supported within drive coupling assembly 210, and first coupling shaft 251 of second force / rotation transmission / conversion assembly 250, second coupling shaft 261 of third force / rotation transmission / conversion assembly 260, and second rotatable proximal drive shaft 281 of first force / rotation transmission / conversion assembly 240 are supported within inner housing member 204, so that the respective angular orientations of proximal drive shaft 212 relative to second rotatable proximal drive shaft 281, proximal drive shaft 216 relative to second coupling shaft 261, and proximal drive shaft 214 relative to first coupling shaft 251 are changed relative to each other.

[0190] The adapter assembly 200 further includes an attachment / detachment button 342 supported thereon, as seen in FIGS. 57-59 . Specifically, the button 342 is supported on the drive coupling assembly 210 of the adapter assembly 200 and is biased to an inactivated state by a biasing member 344. The button 342 includes a lip or ledge 342 a configured to snap behind a corresponding lip or ledge 20 a ( FIG. 18 ) defined along the recess 20 of the connecting portion 108 of the handle housing 102 of the handle assembly 100. During use, when the adapter assembly 200 is connected to the handle assembly 100, the lip 342 a of the button 342 is disposed behind the lip 108 b of the connecting portion 108 of the handle housing 102 of the handle assembly 100, securing and holding the adapter assembly 200 and the handle assembly 100 together. To enable the adapter assembly 200 and the handle assembly 100 to be disconnected from one another, the button 342 is depressed or actuated against the bias of the biasing member 344 to disengage the lip 342a of the button 342 from the lip 108b of the connecting portion 108 of the handle housing 102 of the handle assembly 100.

[0191] As shown in Figures 1 and 66-80, reloader 400 is configured to be operably connected to adapter assembly 200 and configured to fire and form an annular array of surgical staples and to circularly cut tissue.

[0192] Reloader 400 includes a shipping cap assembly (not shown) that is selectively received on distal end 402 of reloader 400 and that can function to facilitate insertion of reloader 400 into a target surgical site and to maintain staples "S" ( FIG. 67 ) within staple cartridge 420 of reloader 400. Shipping cap assembly 401 also functions to prevent premature advancement of staple driver assembly 430 ( FIG. 66 ) of reloader 400 and knife assembly 440 ( FIG. 66 ) of reloader 400 prior to and during attachment of reloader 400 to adapter assembly 200.

[0193] Referring now to Figures 66 to 72, the reloading portion 400 includes a housing 410 having a proximal end portion 410a and a distal end portion 410b, a staple cartridge 420 secured to the distal end portion 410b of the housing 410, a staple driver assembly 430 operably received within the housing 410, a knife assembly 440 operably received within the housing 410, a bushing member 450 received within the proximal end 410a of the housing 410, and a tip assembly 460 mounted around the bushing member 450.

[0194] The housing 410 of the reloading portion 400 includes an outer cylindrical portion 412 and an inner cylindrical portion 414. A plurality of ribs (not shown) interconnect the outer and inner cylindrical portions 412, 414. The outer and inner cylindrical portions 412, 414 of the reloading portion 400 are coaxial and define therebetween a recess 412a ( FIG. 67 ) configured to operably receive the staple driver assembly 430 and the knife assembly 440. The inner cylindrical portion 412 of the reloading portion 400 includes a plurality of longitudinally extending ridges 416 ( FIG. 67 ) projecting from an inner surface thereof and configured to radially align (e.g., clock) the anvil assembly 510 with the reloading portion 400 during a stapling procedure. As described in further detail below, the proximal ends 416a of the longitudinal ridges 416 are configured to facilitate selective securement of the shipping cap assembly 401 with the reloading portion 400. An annular ridge 418 (FIG. 67) is formed on the outer surface of inner cylindrical portion 412 and is configured to help maintain knife assembly 440 in the retracted position.

[0195] Staple cartridge 420 of reloading portion 400 is fixedly secured to distal end 410b of housing 410 and includes a plurality of staple pockets 421 formed therein that are configured to selectively fasten staples "S."

[0196] 66-72, staple driver assembly 430 of reloader 400 includes a driver adapter 432 and a driver 434. Proximal end 432a of driver adapter 432 is configured for selective contact and abutment with support base 255d of outer flexible band assembly 255 of second force / rotation transmission / conversion assembly 250 of adapter assembly 200. In operation, while outer flexible band assembly 255 is distally advanced, support base 255d of outer flexible band assembly 255 contacts proximal end 432a of driver adapter 432, advancing driver adapter 432 and driver 434 from a first or proximal position to a second or distal position, as described above. Driver 434 includes a plurality of driver members 436 aligned with staple pockets 421 of staple cartridge 420 for contacting staples "S." As such, advancement of driver 434 relative to staple cartridge 420 causes ejection of staples "S" from staple cartridge 420.

[0197] 66-72 , knife assembly 440 of reloader 400 includes a knife carrier 442 and a circular knife 444 secured about a distal end 442b of knife carrier 442. A proximal end 442a of knife carrier 442 is configured to operatively connect with support base 265d of internal flexible band assembly 265 of third force / rotation transmission / conversion assembly 260 of adapter assembly 200. In operation, while internal flexible band assembly 265 is distally advanced, support base 265d of internal flexible band assembly 265 connects with proximal end 442a of knife carrier 442 to advance knife carrier 442 and circular knife 444 from a first or proximal position to a second or advanced position, causing severing of tissue disposed between staple cartridge 420 and anvil assembly 510, as described above.

[0198] The distal end 452 b of the bushing member 450 is secured within the proximal end 414 a of the inner cylindrical portion 414 of the housing 410 by a plurality of ridges 452 c formed on the distal end 452 b of the bushing member 450 .

[0199] The tip assembly 460 of the reloading unit 400 includes a housing 461 having an annular flange 462 extending therefrom. The annular flange 462 extends perpendicular to the longitudinal axis of the housing 461. The annular flange 462 is configured to be received around the distal end 452b of the bushing member 450.

[0200] The chip assembly 460 of the reloading unit 400 includes a circuit board assembly 464 secured within a cavity 461a of the housing 461. The circuit board assembly 464 includes a circuit board 464a, a pair of contact members 464b, and a chip 464c (e.g., a storage device 405). A first end of the circuit board 464a supports the chip 464c, and a second end of the circuit board 464a supports the first and second contact members 464b. The chip 464c is a writable / erasable memory chip. The chip 464c contains stored information such as the lot number, staple size, knife diameter, lumen size, firing count, manufacturing stroke offset, excess force index, presence of a shipping cap assembly, and demonstration mode. Chip 464c includes a write function that allows power handle 101 to encode into chip 464c that reload 400 has been used to prevent reuse of an empty, used, or fired reload.

[0201] Further to the foregoing, it is contemplated that the chip 464c (e.g., storage device 405) of the chip assembly 460 of the refill unit 400 is configured to be written with specific performance data related to a currently performed surgical procedure before, during, and / or after the surgical procedure, or a previously performed surgical procedure. Such performance data may be written to the chip 464c upon completion of a successful firing of the surgical device or upon an unsuccessful firing, for example, when the power handle 101 enters a recovery state as described herein.

[0202] Such performance data includes, but is not limited to, clamping force for the surgical procedure, stapling force for the surgical procedure, and / or cutting force for the surgical procedure (e.g., maximum clamping force, maximum stapling force, and / or maximum cutting force). This performance data is also written to an event log in memory 141 of main controller 147 of power handle 101 and recorded in raw data files.

[0203] In this manner, the refiller 400 may be separated from the adapter 200 and / or power handle 101 and returned to a reprocessing facility, manufacturer, or some other facility for disposal, repair, recycling, refurbishment, reprocessing, diagnostic testing, etc. Thus, with the performance data and other aforementioned information stored on the chip 464c of the refiller 400, when the refiller 400 is returned to a facility as part of a field return, etc., the performance data and other aforementioned information may be downloaded or accessed from the chip 464c to provide a technician with information regarding the firings performed by the power handle 101 on that refiller 400. The reprocessing facility may include, but is not limited to, a location within the sterile field of the surgery in an operating room (e.g., within the field of use) and / or an operating room location outside the sterile field of the surgery, a dedicated area / location within the hospital or venue where the surgery is performed, and / or a dedicated location outside the hospital or venue where the surgery is performed (e.g., outside the field of use).

[0204] The data downloaded from the chip 464c of the reloader 400 may be used to diagnose or troubleshoot the root cause of performance issues that may have occurred in the surgical field during use with either the reloader 400, the adapter assembly 200, and / or the power handle 101. For example, because the performance data contained in the reloader 400 matches the performance data contained in the power handle 101, the data on the chip 464c of the reloader 400 may be used to help identify the specific event log in which the problematic firing occurred. The performance data, and / or other aforementioned information stored on the chip 464c of the reloader 400, may be used to provide information about how the firing of the reloader 400 was performed by the power handle 101, as well as potential information about underlying tissue conditions and other surgical conditions during surgery (e.g., environmental conditions, physical / operating conditions of the reloader 400, the adapter assembly 200 and / or the power handle 101, etc.).

[0205] For example, with reference to FIG. 82G and FIGS. 82A-82F (described in more detail below), following a successful stapling sequence, as shown in FIG. 82D, the procedure enters a cutting sequence. In accordance with the present disclosure, performance data is written to tip 464c of reloader 400 when the cutting sequence is successful or when the cutting sequence fails (when power handle 101 enters the recovery state, as described above). More specifically, as shown in FIG. 82G, with respect to writing performance data to tip 464c during the cutting sequence (described in more detail below), power handle 101 actuates reloader 400 to fire annular knife 444 (see FIG. 67) of reloader 400 to cut tissue clamped between staple cartridge 420 of reloader 400 and head assembly 512 of anvil assembly 510. When the cutting sequence is stopped, the power handle 101 automatically writes performance data to the chip 464c of the refill section 400, whether the cutting was successful or unsuccessful, regardless of whether the cutting sequence was stopped or not.

[0206] If the cut is successful and the writing of performance data to tip 464c of refiller 400 is complete, the surgical procedure enters a cut complete state (described in detail below and shown in FIG. 82F) in which head assembly 512 of anvil assembly 510 may tilt. If the cut is unsuccessful and the writing of performance data to tip 464c of refiller 400 is complete, the surgical procedure enters a recovery state (e.g., a surgical site extraction state) in which surgical intervention, etc. may be required (described in detail below and shown in FIG. 82F).

[0207] As noted throughout, in accordance with the present disclosure, the power handle 101 of the handle assembly 100 is configured and capable of actuating / firing various sizes of reloading portions 400 (e.g., having staples of different lengths depending on the thickness of the tissue to be stapled and / or having knives of different diameters depending on the diameter of the tissue to be anastomosed). To enable the firing of various reloading portions 400, each potentially loaded with staples of different lengths, the main controller 147 of the power handle 101 is configured and programmed to monitor and record the axial position of the outer flexible band assembly 255 and the inner flexible band assembly 265 to achieve and monitor the actuation of a specific length of the reloading portion 400 to ensure proper formation and firing of the specific size staples loaded therein, and to ensure proper advancement of the annular knife 444 to fully sever the tissue drawn within the reloading portion and complete the anastomosis.

[0208] According to the present disclosure, the main controller 147 of the power handle 101 monitors the axial position of the outer flexible band assembly 255 and the inner flexible band assembly 265, so that the minimum and maximum lengths of actuation of each particular reloading unit 400 connected to the power handle 101 can be set based on information stored in the chip 464c of the reloading unit 400 (e.g., staple size, knife diameter, lumen size, minimum cutting stroke length, maximum cutting stroke length, etc.). For example, the minimum and maximum lengths of actuation of the inner flexible band assembly 265 for a reloading unit 400 having relatively short staples will be different from the minimum and maximum lengths of actuation of the inner flexible band assembly 265 for a reloading unit 400 having relatively long staples. In this manner, the minimum and maximum cutting stroke for the annular knife 444 can be set for the particular reloading unit 400 attached. For example, for a reloading unit 400 having relatively short staples, the minimum and maximum cutting strokes of each annular knife 444 may be different from the minimum and maximum cutting strokes of each annular knife 444 of a reloading unit 400 having relatively long staples.

[0209] Further, in accordance with the present disclosure, monitoring the maximum cutting stroke of the inner band assembly 265 (associated with a particular reload unit 400) can avoid excessive cutting band actuation and / or tissue compression. Specifically, the maximum cutting stroke of the inner band assembly 265 can be set by the main controller 147 of the power handle 101 depending on the particular reload unit 400 connected to the power handle 101 (via the adapter assembly 200). The main controller 147 then monitors and records the axial position of the inner band assembly 265 to ensure that the maximum cutting stroke (previously set) is not exceeded.

[0210] As described above, and in accordance with the present disclosure, the minimum and maximum cutting stroke values ​​can be unique to each particular reloader 400 (e.g., based on staple size, knife diameter, etc.), and the minimum and maximum cutting strokes can be changed with each firing of the power handle 101 based on information stored in the chip 464c of the reloader 400 and / or based on information stored in or communicated to the power handle 101.

[0211] 66-72, the proximal end 410a of the housing 410 is configured for selective connection to the connector sleeve 290 of the adapter assembly 200. Specifically, the outer cylindrical portion 412 of the housing 410 terminates in a proximal cylindrical flange 412a having an inner diameter that is larger than the diameter of the distal end portion 290a of the connector sleeve 290 of the adapter assembly 200. Additionally, the proximal end 432a of the driver adapter 432 has an outer diameter that is smaller than the diameter of the distal end portion 290a of the connector sleeve 290.

[0212] Reloader 400 includes a compression release ring 413 supported on flange 412a of outer cylindrical portion 412 of housing 410. Release ring 413 has a substantially oval profile including a relative major axis and a relative minor axis. In operation, when a radially inward force acts along the major axis of release ring 413 (as shown by arrow "A1" in FIG. 70), release ring 413 flexes radially outward along its minor axis (as shown by arrow "A2" in FIG. 70).

[0213] The release ring 413 includes a ramp feature 413a that protrudes radially inward and is located substantially along a minor axis of the release ring 413. The ramp feature 413a of the release ring 413 extends through a window 412b defined in a flange 412a of the outer cylindrical portion 412 of the housing 410. The ramp feature 413a of the release ring 413 protrudes radially inward sufficiently to be selectively received in a window 290b defined in the distal end portion 290a of the connector sleeve 290.

[0214] The reloader 400 includes a retaining ring 415 connected to the outer cylindrical portion 412 of the housing 410 and configured to help retain the release ring 413 on the outer cylindrical portion 412 of the housing 410 .

[0215] For radial alignment and clocking of the reloading portion 400 with the adapter assembly 200, the reloading portion 400 includes a longitudinally extending rib 412c protruding radially inward from the outer cylindrical portion 412 of the housing 410 configured for slidable reception within a longitudinally extending slot 290c defined in the distal end portion 290a of the connector sleeve 290.

[0216] To connect the reload portion 400 to the adapter assembly 200, the ribs 412c of the reload portion 400 are radially aligned with the longitudinally extending slots 290c of the connector sleeve 290 of the adapter assembly 200. The reload portion 400 and the adapter assembly 200 are then axially moved toward one another until the distal end portion 290a of the connector sleeve 290 is received within the flange 412a of the outer cylindrical portion 412 of the housing 410 and the ramp feature 413a of the release ring 413 is received in the window 290b of the connector sleeve 290. Thus, the reload portion 400 and the adapter assembly 200 are locked together.

[0217] When reload unit 400 is connected to adapter assembly 200 , distal electrical connector 322 of adapter assembly 200 is mechanically and electrically connected to tip assembly 460 of reload unit 400 .

[0218] To disconnect the reload portion 400 and the adapter assembly 200 from one another, the release ring 413 is squeezed along its longitudinal axis (in the direction of arrow "A1"), thereby disengaging the ramp feature 413a of the release ring 413 from within the window 290b of the connector sleeve 290. Thus, the reload portion 400 and the adapter assembly 200 can be axially separated from one another.

[0219] 71-75, anvil assembly 510 is provided and configured for selective connection to trocar member 274 of adapter assembly 200 and for cooperation with reloader 400.

[0220] Anvil assembly 510 includes a head assembly 512 and a central rod assembly 514. Head assembly 512 includes a post 516, a housing 518, a cutting ring 522, a cutting ring cover 523, an anvil plate 524, a spacer or washer 525, a cam latch member 526, and a retaining member 527. Post 516 is centrally positioned within housing 518.

[0221] Still referring to Figures 73-75, anvil plate 524 is supported within an exterior annular recess 528 of housing 518 and includes a plurality of staple pockets 530 formed therein and configured to receive and form staples.

[0222] The cutting ring 522 includes a central opening positioned around the post 516 within an internal annular recess of the housing 518 between the post 516 and an external annular recess 528. The cutting ring 522 is formed from polyethylene. A cutting ring cover 523 is secured to the outward or proximal surface of the cutting ring 522.

[0223] The retaining member 527 is positioned in an internal annular recess between the cutting ring 522 and the rear wall of the housing 518. The retaining member 527 is annular and includes a plurality of deformable tabs that engage the rear surface of the cutting ring 522. The retaining member 527 prevents the cutting ring 522 from moving or being forced into the internal annular recess of the housing 518 until a predetermined force is applied to the cutting ring 522 sufficient to deform the tabs. For example, when a predetermined force is reached during cutting of tissue, the cutting ring 522 is forced into the internal annular recess 536, compressing the retaining member.

[0224] Returning to FIG. 75 , anvil center rod assembly 514 includes a center rod 552, a plunger 554, and a plunger spring 556. A first end of center rod 552 includes a pair of arms 159 that define a cavity 159 a. A pivot member 562 is provided to pivotally secure post 516 to center rod 552 such that anvil head assembly 512 is pivotally mounted to anvil center rod assembly 514.

[0225] Cam latch member 526 is pivotally mounted within a transverse slot in post 516 of housing 518 and about pivot pin 562. Cam latch member 526 has an external cam profile that allows plunger 554 to move forward when cam latch member 526 rotates clockwise and allows plunger 554 to retract when cam latch member rotates counterclockwise.

[0226] Plunger 554 is slidably positioned in a hole formed in a first end of central rod 552. Plunger 554 includes an engagement finger that is offset from the pivot axis of anvil head assembly 512 and biased to engage an end of cam latch 526. Engagement of the finger of plunger 554 with the end of cam latch 526 causes a tip portion of the end of cam latch 526 to press against the inner periphery of cut ring 522, urging anvil head assembly 512 onto central rod 552 into an operative or non-tilted position.

[0227] In the pre-fired tilted position, the anvil head assembly 512 can be tilted relative to the anvil center rod assembly 514. The tilt of the anvil head assembly 512 relative to the anvil center rod assembly 514 allows the body portion of the cam latch member 526 to engage the finger 166 of the plunger 554. As the cam latch 526 rotates with the tilt of the anvil head assembly 512, the plunger 554 retracts with the bore of the anvil center rod assembly 514, thereby compressing the spring 556. In this manner, the finger 566 of the plunger 554 is biased distally against the body portion of the cam latch member 526.

[0228] 74 and 75 , a second end of central rod 552 includes a bore 580 defined by a plurality of flexible arms 582. The proximal end of each of flexible arms 582 includes an internal shoulder dimensioned to releasably engage a shoulder of trocar 274 of trocar member 270 of adapter assembly 200 to secure anvil assembly 510 to adapter assembly 200. A plurality of splines 586 are formed around central rod 552. Splines 586 function to align and / or clock anvil assembly 510 with staple cartridge 420 of reloader 400.

[0229] 76-81, the reloader 400 is configured for selective optional connection to an external irrigation source via irrigation tube 590. Irrigation tube 590 is configured to deliver air or saline to the anastomosis site for purposes of leak testing, improved insertion, or insufflation of the rectal stump.

[0230] Irrigation tube 590 terminates at its proximal end 590a with a proximal luer fitting 591 configured to connect to a syringe (not shown) and at its distal end 590b with a distal fitting 592 configured to selectively snap-fit ​​connect to port 410c of housing 410 of reloading unit 400. Distal fitting 592 includes a pair of resilient fingers 592a configured to engage respective shoulders 410d defined in port 410c of housing 410.

[0231] 89, a schematic diagram of the power handle 101, the circular adapter assembly 200, and the reloader 400 is shown. For simplicity, only one of the motors 152, 154, 156 is shown, namely, motor 152. The motor 152 is coupled to the battery 144. In an embodiment, the motor 152 may be coupled to any suitable power source configured to provide electrical energy to the motor 152, such as an AC / DC transformer.

[0232] The battery 144 and motor 152 are coupled to a motor controller circuit board 142a having a motor controller 143 that controls the operation of the motor 152, including the flow of electrical energy from the battery 144 to the motor 152. A main controller circuit board 142b (FIGS. 12 and 13) includes a main controller 147 that controls the power handle 101. The motor controller 143 includes a plurality of sensors 408a, 408b, ... 408n configured to measure the operating conditions of the motor 152 and the battery 144. The sensors 408a-n may include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n can measure the voltage, current, and other electrical characteristics of the electrical energy supplied by the battery 144. The sensors 408a-408n can also measure the angular velocity (e.g., rotational speed) of the motor 152, such as revolutions per minute (RPM), torque, temperature, current draw, and other operating characteristics. Angular velocity can be determined by measuring the rotations of motor 152 or a drive shaft (not shown) coupled to and rotatable by motor 152. The position of the drive shaft, which is movable in various axial directions, may be determined using various linear sensors disposed in or near the shaft or may be estimated from RPM measurements. In embodiments, torque may be calculated based on the adjusted current draw of motor 152 at a constant RPM. In further embodiments, motor controller 143 and / or main controller 147 may measure time and process the values ​​as a function of time, including integration and / or differentiation, to determine, for example, the rate of change of the measurements. Main controller 147 is also configured to determine the distance traveled by various components of circular adapter assembly 200 and / or reloader 400 by counting rotations of motors 152, 154, and 156.

[0233] Motor controller 143 is coupled to main controller 147, which includes a number of inputs and outputs for interfacing with motor controller 143. In particular, main controller 147 receives measured sensor signals from motor controller 143 regarding the operating conditions of motor 152 and battery 144, and then outputs control signals to motor controller 143 to control the operation of motor 152 based on the sensor readings and the instructions of certain algorithms, which are discussed in more detail below. Main controller 147 is also configured to accept a number of user inputs from a user interface (e.g., switches, buttons, a touchscreen, etc., coupled to main controller 147).

[0234] The main controller 147 is also coupled to a memory 141 disposed on the main controller circuit board 142b. The memory 141 may include volatile (e.g., RAM) and non-volatile storage devices configured to store data including software instructions for operating the power handle 101. The main controller 147 is also coupled to the strain gauges 320 of the circular adapter assembly 200 using a wired or wireless connection and is configured to receive strain measurements from the strain gauges 320 used during operation of the power handle 101.

[0235] Reloader 400 includes a data / information storage device 405 (e.g., chip 464c). Circular adapter assembly 200 also includes a storage device 407. Storage devices 405 and 407 also include non-volatile storage media (e.g., EEPROM) configured to store any data related to reloader 400 and circular adapter assembly 200, respectively, including, but not limited to, usage counts, identification information, model numbers, serial numbers, staple sizes, knife diameters, stroke lengths, maximum actuation forces, minimum actuation forces, factory calibration data, and the like. In embodiments, the data may be encrypted and decryptable only by a device (e.g., main controller 147) with the appropriate key. The data may also be used by main controller 147 to authenticate circular adapter assembly 200 and / or reloader 400. Storage devices 405 and 407 can be configured in read-only or read / write mode, which allows main controller 147 to read and write data to storage devices 405 and 407 .

[0236] The operation of the handle assembly 100, the circular adapter assembly 200, and the reloader 400 will now be described with reference to Figures 82A-82F, which illustrate a flowchart of the operation process. With particular reference to Figure 82A, the power handle 101 is removed from a charger (not shown) and activated. The power handle 101 performs a self-check upon activation, and if the self-check is passed, the power handle 101 displays an animation on the display screen 146 showing how the power handle 101 should be inserted into the shell 10.

[0237] After the power handle 101 is inserted into the shell housing 10, the power handle 101 verifies that it is properly inserted into the shell housing 10 by establishing communication with the electrical connector 66 of the shell housing 10, which has a chip (not shown) disposed therein. The chip in the electrical connector 66 stores a usage counter that the power handle 101 uses to verify that the shell housing 10 has not been used previously. The data stored on the chip (e.g., the number of uses) is encrypted and authenticated by the power handle 101 before determining whether the number of uses stored on the chip exceeds a threshold (e.g., if the shell housing 10 has been used previously).

[0238] Referring to FIG. 82B , after the power handle 101 is enclosed within the shell housing 10 to form the handle assembly 100, the adapter assembly 200 is coupled to the handle assembly 100. After attachment of the circular adapter assembly 200, the handle assembly 100 first verifies that the circular adapter assembly 200 is coupled to the handle assembly 100 and authenticates the circular adapter assembly 200 by establishing communication with the storage device 407 of the circular adapter assembly 200. Data stored in the storage device 407 (e.g., number of uses) is encrypted and authenticated by the power handle 101 before determining whether the number of uses stored in the storage device 407 exceeds a threshold (e.g., if the adapter assembly 200 has been used before). The power handle 101 then performs a verification check (e.g., lifespan check, missing trocar member 274, etc.), and the handle assembly 100 calibrates the circular adapter assembly 200 after confirming that the trocar member 274 is attached.

[0239] After the circular adapter assembly 200 has been calibrated, an unused reload part 400, along with a shipping cap assembly 401, is coupled to the circular adapter assembly 200. The handle assembly 100 verifies that the circular reload part 400 is attached to the circular adapter assembly 200 by establishing communication with the storage device 405 of the circular reload part 400. Referring to FIG. 82C, the power handle 101 also verifies that the circular reload part 400 has not been previously activated by authenticating the storage device 405 and checking the number of uses. The number of uses is adjusted and encoded by the handle assembly 100 after use of the circular reload part 400. If the circular reload part 400 has been previously used, the handle assembly 100 displays an error indicating so on the display screen 146.

[0240] The power handle 101 also performs a calibration using the reloader 400 attached to the circular adapter assembly 200 to determine the hard stop initiation position. The main controller 147 calculates the distance traveled by the motors 152, 154, and 156 to calculate the hard stops. The main controller 147 also uses the distance traveled during calibration to verify that the reloader 400 is unused. Thus, if the distance traveled is determined to exceed a predetermined hard stop threshold, the main controller 147 verifies that staples have previously been ejected from the reloader 400 and marks the reloader 400 as used if it was not previously properly marked. Once the anvil assembly 510 is attached, the main controller 147 performs another calibration.

[0241] 82C , upon installation of the circular reloader 400 and verification that the circular reloader 400 is unused and authenticated, the handle assembly 100 prompts the user to eject the shipping cap assembly 401 by prompting the user to press the top of the toggle control button 30. The prompt is animated on the display screen 146 along with a flashing arrow pointing toward the toggle control button 30. When the user presses the top of the toggle control button 30, they activate the automatic extension (and retraction) of the trocar member 274 until the shipping cap assembly 401 is ejected, at which point the shipping cap ejection process is complete and the handle assembly 100 is now ready for use.

[0242] In an embodiment, the circular adapter assembly 200 also operates with a reloader 400 having a disposable transanal / abdominal introducer. Once the reloader 400 with introducer is attached, the handle assembly 100 displays a ready screen. This allows the user to more easily insert the circular adapter assembly 200, along with the reloader 400, through an abdominal incision. Thus, when the toggle control button 30 is pressed, a prompt to eject the introducer is displayed, similar to the animation for ejecting the shipping cap assembly 401. When the user presses the top of the toggle control button 30, this activates automatic extension (and retraction) of the trocar member 274 until the introducer is ejected, at which point the introducer ejection process is complete.

[0243] 82C , after the shipping cap assembly 401 or introducer is removed, the user begins the surgical procedure, which includes preparing the target tissue area and positioning the circular adapter assembly 200 within the colorectal or upper gastrointestinal region, or until the trocar members 274 are sufficiently extended to allow penetration of the tissue. The user presses the toggle control button 30 to extend the trocar members 274 until they penetrate the tissue. While the trocar members 274 are being extended, an animation depicting the extension process is displayed on the display screen 146. In addition, a scale indicates the distance traveled by the trocar members 274, and an arrow indicates the direction of travel of the trocar members 274. The trocar members 274 are extended until they reach the maximum extension distance, as indicated on the display screen 146.

[0244] 82C-82D and 86, which show a flowchart of the clamping process, after trocar member 274 is extended, anvil assembly 510 (already positioned by the surgeon) is attached to trocar member 274, and the user initiates the clamping process of tissue placed between circular reloader 400 and anvil assembly 510 by pressing the bottom of toggle control button 30. The clamping process is also shown as an animation on display screen 146, with an arrow indicating the retraction direction, for example, highlighted, as the reverse of the animation of trocar member 274 extension.

[0245] During clamping, the anvil assembly 510 retracts toward the circular reloading portion 400 until it reaches a fully compressed position, i.e., the position of the anvil assembly 510 where the tissue is fully compressed between the anvil assembly 510 and the reloading portion 400. The fully compressed distance is different for each different type of reloading portion (e.g., the distance is approximately 29 mm for a 25 mm reloading portion). During clamping, the strain gauge assembly 320 continuously provides measurements to the main controller of the force applied to the first rotational transfer assembly 240 when moving the anvil assembly 510.

[0246] Referring to FIG. 83 , which schematically illustrates the travel distance and speed of the anvil assembly 510 as it is retracted by the first motor 152, the anvil assembly 510 initially retracts a first segment from the fully open position marker 600 to a first distance marker 602 at a first speed. The anvil assembly 510 then traverses a second distance from the first distance marker 602 to a second distance marker 604 at a second speed slower than the first speed. As the anvil assembly 510 traverses the second segment, the main controller 147 continuously verifies whether the measured force is within predefined parameters to determine whether the measured force exceeds a high force threshold limit before reaching the compression start distance ( FIGS. 83 and 86 ). This measurement is used to detect misalignment of the splines 586 of the trocar member 274 with the longitudinally extending ridges 416 of the reloading portion 400. If the force is higher than the high force threshold, the power handle 101 temporarily reverses the rotational transmission assembly 240 to retract the anvil assembly in an attempt to correct the misalignment of the spline 586. The main controller 147 then retries to continue tightening until the third distance marker 604 is reached. If the third distance marker 604 is not reached within a predetermined period of time, the main controller 147 then issues an error, including an alarm on the display screen 146, prompting the user to inspect the anvil assembly 510. After inspecting and removing the obstruction, the user can resume the tightening process.

[0247] When the anvil assembly 510 reaches the third distance marker 604 at the end of the second segment, the power handle 101 performs a rotational verification to check the position of the anvil assembly 510. The main controller then initiates a controlled tissue compression (“CTC”) algorithm, which varies the clamping speed during tissue compression without exceeding the target compressive force.

[0248] The CTC uses a second-order predictive force filter to compensate for slowly and rapidly changing forces applied to the tissue during compression. As the predicted force approaches the target force, the clamping rate slows to prevent overshoot. If the measured force reaches the target force and the clamping gap has not yet been achieved, clamping is stopped to allow tissue relaxation. During tissue relaxation, the CTC resumes after the measured force falls below the target clamping force. The force applied to the tissue is derived from strain measurements by the main controller 147 from the strain gauge assembly 320.

[0249] During CTC, the user continues to press toggle control button 30 to continue operating handle assembly 100. The third distance marker 604, at which the controller initiates CTC, corresponds to the distance at which the anvil assembly 510 begins compressing tissue against the staple guides of the circular reloader 400 for the remainder of the clamping process. The CTC controls the movement of the anvil assembly 510 during the third segment from the third distance marker 604 to the fourth distance marker 606, which corresponds to a fully compressed position of the anvil assembly 510. The CTC continues until the anvil assembly 510 reaches the fourth distance marker 606. If no force is detected during clamping, the handle assembly 100 identifies that the anvil assembly 510 is missing, and the handle assembly 100 issues an error.

[0250] CTC is run for predetermined periods of time, i.e., a first period and an optional second period. During CTC, the main controller monitors the force, based on the strain measured by the strain gauge assembly 320, imparted to the first rotational transmission assembly 240 as it moves the anvil assembly 510 until the measured force approaches the target clamping force.

[0251] During CTC execution, the main controller 147 determines whether the measured force approaches the target clamping force by calculating a predicted clamping force using a quadratic predictive filter. The target clamping force may be any suitable threshold between approximately 100 pounds and approximately 200 pounds, and in embodiments, the target clamping force may be approximately 150 pounds. The CTC calculates the predicted clamping force and compares it to the target clamping force. The main controller samples multiple strain gauge values ​​at a predetermined frequency (e.g., every 1 millisecond) during a predetermined sampling period. The main controller 147 then calculates a filtered strain gauge value using a first plurality of strain gauge samples acquired during the sampling period. The main controller 147 stores the multiple filtered strain gauge values ​​and uses three strain gauge samples to predict the target clamping force. In particular, the main controller 147 first calculates a first difference between the first two (e.g., first and second) filtered strain gauge values, which provides a primary comparison. More specifically, the main controller 147 then calculates a second difference between two subsequent filtered strain gauge values ​​(e.g., second and third values). In embodiments, the subsequent filtered strain gauge value does not contain the second value used to calculate the first difference, but may be any other subsequent value. The first difference is then divided by the second difference to obtain a difference percentage. The main controller determines a target clamping force based on the predicted strain change, which is calculated by multiplying the first difference by the difference percentage and a value representing the strain extrapolation for a future period. The predicted strain change is then added to the current filtered strain gauge value to determine a predicted strain value corresponding to the predicted clamping force.

[0252] If the predicted tightening force exceeds the target force, the PWM voltage driving the motor 152 driving the first rotational transmission assembly 240 is set to zero. The force continues to be monitored, and if the force falls below the target threshold, the speed of the motor 152 is set to an updated speed to continue the tightening process. This process is repeated until the fourth distance marker 606 is reached.

[0253] The target speed is calculated by the main controller 147 based on the strain ratio. The strain ratio is calculated by subtracting the predicted strain value from the target clamping force and dividing the difference by the target clamping force. The strain ratio is then used to determine a speed offset by multiplying the difference between the maximum and minimum speeds of the motor 152 by the strain ratio. The speed offset is then added to the minimum speed of the motor 152 to determine the target speed. The target speed is used to control the motor 152 in response to the motor deviating by a predetermined amount from its currently set speed (e.g., when the motor 152 deviates by approximately 50 revolutions per minute). Additionally, if the current speed of the motor 152 is zero, for example, when the predicted clamping force approaches the target force, the motor 152 is set to the newly calculated target speed. This allows the speed of the motor 152 to be varied while maintaining the desired force on the tissue during clamping.

[0254] The target clamping force is fixed for a first period. If thick tissue is encountered, the clamping gap may not be reached within the first period (e.g., the fourth distance marker 606 is reached), and clamping is stopped and the operator is notified via the display screen. If the operator chooses to continue the clamping operation, the CTC continues operation for a second period, during which the target clamping force is incremented until the maximum force is reached. During the second period, the clamping travel distance is monitored to determine whether the anvil assembly 510 is moved in response to an increase in incremental force. Thereafter, the clamping distance is periodically monitored for minimum movement. If minimum movement is not detected, the target force is dynamically incremented by a proportional amount based on the difference between the current clamping position and the fourth distance marker 606. If a maximum force higher than the target clamping force is detected, all clamping is stopped. Additionally, if clamping is not achieved within the second period, the CTC issues a warning. This may include instructing the user on the display screen 146 to check the clamping site for obstructions. If none are found, the user can continue the clamping process. If clamping is not complete, for example, if the second time period expires and / or the maximum force limit is reached, another warning is triggered instructing the user to check tissue thickness and restart the clamping process using a larger reloader 400.

[0255] 82C-82D and 86, when the CTC is initiated, after the main controller 147 determines the presence of the anvil assembly 510 based on minimum force detection, the display screen 146 displays the CTC user interface. In particular, the distance scale on the display screen 146 is replaced with a gauge indicating the force being applied to the tissue, and the trocar is replaced with the anvil and tissue being compressed. Also displayed is the progress of tightening until the fourth distance marker 606 is reached. Thus, as the anvil assembly 510 moves to compress the tissue beneath the CTC, the gauge, animation of the anvil, and the distance traveled by the anvil assembly 510 are continually updated to provide real-time feedback on the progress of the CTC.

[0256] During CTC, the strain gauge assembly 320 continuously provides measurements to the main controller of the force applied to the first rotational transmission assembly 240 when moving the anvil assembly 510. The force measured by the strain gauge assembly 320 is represented by a gauge on the display screen 146, which is divided into three zones. Zone 1 indicates a force from 0% to 50% of the target clamping force, Zone 2 indicates a force from 51% to 100%, and Zone 3 indicates a maximum force above the target clamping force. A high force caution graphic is displayed on the screen in Zone 3, and the user must perform a second actuation of the toggle to confirm clamping despite the high force in Zone 3.

[0257] The user can then press the toggle control button 30 to re-clamp, which will move the anvil assembly 510 until the force reaches the maximum force limit of Zone 3. This allows for further compression of the tissue in certain situations as the user deems necessary, for example, based on tissue thickness. Once the CTC algorithm is complete and the tissue is compressed, the handle assembly 100 will activate an LED and issue an audible signal. A CTC screen showing 100% compression will be continuously displayed on the display screen 146 until the stapling sequence is initiated. A pre-fire calibration is performed prior to the initiation of the stapling sequence.

[0258] 82D and 87A-87B, to initiate a stapling sequence, the user presses one of the safety buttons 36a or 36b on the power handle 101, which functions as a safety and enables the toggle control button 30 to be armed and begin stapling. When the safety button 36a or 36b is actuated, a second rotation verification calibration check is performed. The display screen 146 transitions to a stapling sequence display, including a circle showing an animated representation of a circular anastomosis, a progress bar, and staple icons. The stapling sequence screen is displayed until the user initiates the stapling sequence, terminates the stapling sequence, or releases clamping. At the start of the stapling sequence, an LED begins flashing and an audio sound plays. The LED continues flashing throughout the duration of the stapling and severing sequence.

[0259] To initiate the stapling sequence, the user depresses the toggle control button 30, which moves the second rotational transfer assembly 250, converting rotation into linear motion to eject and form staples from the circular reloader 400. In particular, during the firing sequence, the second motor 152 advances the driver 434 using the second rotational transfer assembly 250. The force applied to the second rotational transfer assembly 250 is monitored by the strain gauge assembly 320. The process is considered complete when the second rotational transfer assembly 250 reaches a hard stop corresponding to the force threshold, as detected by the strain gauge assembly 320. This indicates that the staples have been successfully ejected and deformed against the anvil assembly 510.

[0260] 84, which schematically illustrates the distance and speed of travel of the second motor 154 when advancing the driver 434, the driver 434 initially advances from a first position marker 608 (e.g., a hard stop) at a first speed a first segment from the first distance marker 608 to a second distance marker 610. From the second distance marker 610, the driver 434 advances at a second speed slower than the first speed until it reaches a third distance marker 612, ejecting the staples.

[0261] During the first segment, the second motor 154 advances the driver 434 until it contacts a staple and initiates firing. The main controller 147 also writes to the storage devices 405 and 407 of the reloader 400 and the circular adapter assembly 200. In particular, the main controller 147 marks the reloader 400 as "used" in the storage device 405 and increments the usage count in the storage device 407 of the circular adapter assembly 200.

[0262] After reaching the second distance marker 610, the second motor 154 operates at a second, slower speed to eject the staples from the reloader 400. Referring to FIG. 87B , during the second segment, as the staples are ejected from the reloader 400 into the stapled tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 320 and determines whether the force corresponding to the measured strain is between the minimum and maximum staple fastening forces. The staple fastening force range can be stored in the memory device 405 of the reloader 400 and used by the main controller 147 during the stapling sequence. Determining whether the measured force is below the minimum staple fastening force is used to verify that staples are present in the reloader 400. Additionally, a low force can also indicate a failure of the strain gauge 320. If the measured force is below the minimum stapling force, main controller 147 sends a signal to second motor 154 to retract driver 434 to second distance marker 610. Main controller 147 also terminates the stapling sequence and displays a sequence on display 146 instructing the user on the steps to retract anvil assembly 510. After removing anvil assembly 510, the user can replace circular adapter assembly 200 and reloader 400 and restart the stapling process.

[0263] If the measured force exceeds the maximum stapling force, which may be approximately 500 pounds, the main controller 147 stops the second motor 154 and displays a sequence on the display 146 instructing the user on steps to terminate the stapling sequence. However, the user can continue the stapling process without force limit detection by pressing the toggle control button 30.

[0264] The main controller 147 determines that the stapling process is successfully completed when the second motor 154 reaches the third distance marker 612 associated with the stapled tissue and the strain measured during this movement is within the minimum and maximum staple force limits. The second motor 154 then retracts the driver 434 to the fourth distance marker 614 to release pressure on the tissue, and then to the second distance marker 610, before initiating the cutting sequence.

[0265] The main controller 147 is also configured to compensate for band compression of the outer flexible band assembly 255 during the stapling process, which can result in a non-linear relationship between the motor positions determined by the main controller 147 and the positions of the components of the circular adapter assembly 200. The main controller 147 is configured to resolve discrepancies between the calculated positions of the motors 152, 154, 156 and the actual positions of the components of the circular adapter assembly 200 using a quadratic mapping of the force changes that result in the discrepancies. The force changes are based on strain measurements from the strain gauge assembly 320. In particular, the main controller 147 maintains a count of lost rotations by the motors 152, 154, 156, i.e., rotations that did not result in movement of the components of the circular adapter assembly 200 based on the force applied to the components of the circular adapter assembly 200, e.g., due to compression. The main controller 147 accumulates the total number of lost rotations each time the applied force changes by a predetermined amount, e.g., approximately 5 pounds. The motor position is then adjusted by the sum of the accumulated lost revolutions values ​​to determine if the target position has been reached.

[0266] Referring to FIG. 82D, the progression of staple firing is indicated by animations of the anastomosis, firing progress bar, and staple formation. In particular, the animation shows the staple legs penetrating the tissue and then forming to create a concentric staple line. Once the stapling sequence is complete, the perimeter is displayed in green. The staple icon also initially shows an unformed staple, followed by the staple legs curling inward. The progress bar is divided into two segments, the first segment showing the stapling process and the second segment showing the cutting process. Thus, as the stapling sequence progresses, the progress bar continues to fill until it reaches the midpoint.

[0267] 82E and 88A-88B, after the stapling sequence is completed, the power handle 101 automatically initiates a cutting sequence. During the cutting sequence, the third motor 154 advances the knife assembly 440 using the third rotational transmission assembly 260. The force applied to the third rotational transmission assembly 260 is monitored by the strain gauge assembly 320. The process is considered complete when the third rotational transmission assembly 260 reaches a hard stop corresponding to a force threshold and is detected by the strain gauge assembly 320, or reaches a maximum position. This indicates that the knife assembly 320 has cut the stapled tissue.

[0268] 85, which schematically illustrates the distance and speed of travel of the third motor 156 when advancing the knife assembly 440. The knife assembly 440 initially advances from the first position marker 616 at a first speed a first segment from the first distance marker 616 to the second distance marker 618. From the second distance marker 618, the knife assembly 440 advances at a second speed slower than the first speed until it reaches the third distance marker 620, cutting the stapled tissue.

[0269] During the first segment, the third motor 156 advances the knife assembly 440 until it contacts the stapled tissue. After reaching the second distance marker 618, the third motor 154 operates at a second, slower speed to cut the stapled tissue. Referring to FIGS. 88A-88B , during the second segment, as the knife assembly 440 advances to cut the tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 320 and determines whether the force corresponding to the measured strain is between the target cut force and the maximum cut force. The target cut force and the maximum cut force can be stored in the memory device 405 of the reloader 400 and used by the main controller 147 during the cutting sequence. If the target cut force is not reached during the cutting sequence, indicating an improper cut, the main controller 147 signals the third motor 156 to retract the knife assembly 440 and allows the user to open the reloader 400 to abort the cutting sequence. The main controller 147 also displays a sequence on the display 146 instructing the user to terminate the cutting sequence and retract the anvil assembly 510. After removing the anvil assembly 510, the user can replace the circular adapter assembly 200 and the reloader 400 and resume the stapling process. If the measured force exceeds the maximum cut force, the main controller 147 displays a sequence on the display 146 instructing the user to stop the third motor 156 and terminate the cutting sequence.

[0270] The main controller 147 determines that the stapling process is successfully completed when the knife assembly 440, being moved by the third motor 156, reaches the third distance marker 620 associated with the cut tissue and the strain measured during this movement is within the target and maximum cut force limits. The third motor 154 then retracts the knife assembly 440 back to the first distance marker 616.

[0271] Each of the distance markers 600-620 is stored in memory 141 and / or storage device 405 and is used by main controller 147 to control the operation of power handle 101 and, accordingly, actuate various components of circular adapter assembly 200. As noted above, distance markers 600-620 may vary for different types of reloaders, compensating for variations in staple size, reloader diameter, etc. Additionally, distance markers 600-620 are set from hard stops determined during the calibration process described above.

[0272] Referring to FIG. 82E, the cutting sequence is indicated by the same user interface, except that the staple icon is grayed out and the knife icon is highlighted. During the cutting sequence, the knife icon is animated, with a progress bar moving from the midpoint to the right. Additionally, when the cutting sequence is complete, the inner circumference of the circle is displayed in green. During the cutting sequence, the force applied to the third rotational transmission assembly 260 is monitored by the strain gauge assembly 320 to ensure that the maximum force limit is not exceeded. The process is considered complete when the third rotational transmission assembly 260 reaches a hard stop or force threshold detected by the strain gauge assembly 320, indicating that the knife has successfully incised the tissue. Completion of the cutting sequence is indicated by another sound, and the LED stops flashing and remains lit.

[0273] Referring to FIG. 82F , after the stapling and severing sequence is completed, the user initiates an unclamping sequence to release the anvil assembly 510 from the trocar member 274 by pressing the top of the toggle control button 30. When the toggle control button 30 is pressed up, the trocar member 274 automatically extends distally, thereby moving the anvil assembly 510 away from the circular reloader 400 and unclamping the tissue to a preset anvil tilt distance. The unclamping sequence is shown on the display screen 146. In particular, the unclamping animation shows the anvil assembly 510 moving distally and the head assembly 512 tilting. In addition, the display screen 146 also shows a lock icon indicating that the anvil assembly 510 is secured to the trocar member 274. Once the anvil assembly 510 has moved its tilt distance away from the reloader 400, the display screen 146 shows the anvil assembly 510 in an extended position with the head assembly 512 tilted. This indicates that the user may remove the circular adapter assembly 200 from the patient. The LED then turns off. Once the circular adapter assembly 200 is removed, the user can unlock the anvil assembly 510 from the trocar member 274 by pressing one of the left or right control buttons 32a, 32b, 34a, 34b on the power handle 101 for a predetermined period of time (e.g., three seconds or more). The display screen 146 indicates which button on the power handle 101 must be pressed to unlock the anvil assembly 510. While the user is pressing one of the control buttons 32a, 32b, 34a, 34b, the display screen 146 displays a countdown (e.g., 3, 2, 1) and the lock icon indicates that it is in the unlocked state. At this point, the anvil assembly 510 is unlocked and can be removed. The user can then remove the reloader 400 and the severed tissue from the resection procedure. The circular adapter assembly 200 is also removed from the handle assembly 100 and cleaned and sterilized for later reuse.The shell 10 is opened and discarded, and the power handle 101 is removed therefrom for reuse.

[0274] With regard to cleaning and / or sterilization of adapter assembly 200 for later reuse, the interior of adapter assembly 200 is sealed against the ingress of any, or most, fluids or moisture. If fluids or moisture were to enter the interior of adapter assembly 200, during a surgical procedure or cleaning / sterilization process, the sterilization (for subsequent use) and electronic functionality (e.g., of electrical assembly 310, see FIG. 53 ) of adapter assembly 200 could be affected. If the internal temperature of adapter assembly 200 reaches a sufficiently high temperature or for a sufficiently long period during any sterilization and / or autoclave cycle, any fluids or moisture that enter adapter assembly 200 can be reliably evacuated. Therefore, adapter assembly 200 is equipped with certain features to more reliably ensure that complete evacuation of fluids or moisture is achieved by the end of the autoclave cycle, regardless of the settings of the autoclave equipment and / or fluctuations in the internal temperature of adapter assembly 200 achieved during the autoclave cycle.

[0275] According to the present disclosure, to address the above-described occurrences of fluid or moisture entering or leaving the adapter assembly 200, the adapter assembly 200 is equipped with thermal data logging capabilities. Specifically, and returning immediately to FIG. 53 , the electronics assembly 310 of the adapter assembly 200, and more specifically, the circuit board 312b of its proximal pin connector 312, may include an electronic temperature sensor 312c (e.g., a thermistor) integrated onto the circuit board 312b. The electronic temperature sensor 312c can be interrogated by an on-board microprocessor (not shown) of the circuit board 312b to log the temperature of the adapter assembly 200.

[0276] Achieving a particular temperature threshold and / or a particular duration / time threshold has been established to correlate with complete drainage / ejection of moisture from adapter assembly 200 during a sterilization or autoclaving cycle, etc. In accordance with the present disclosure, upon connecting adapter assembly 200 to power handle 101, a user can be provided with information regarding complete sterilization / autoclaving of adapter assembly 200 and / or complete drainage of fluids or moisture from within adapter assembly 200. For example, this may be accomplished by providing a separate indicator (not shown) on adapter assembly 200 and / or by activating an image / signal on display screen 146 (see FIG. 12 ).

[0277] It is further contemplated that adapter assembly 200 may include a mechanical temperature logger (not shown) in addition to or in lieu of electronic temperature sensor 312c. For example, the mechanical temperature logger may include a wax piece of known size, mass, melting point, etc., which melts after a minimum temperature threshold is achieved during the sterilization / autoclaving cycle, thereby indicating that adequate heat has been applied for an appropriate period of time to indicate that the liquid or moisture has been completely expelled.

[0278] According to the methods of the present disclosure, following a surgical procedure, adapter assembly 200 is reusable and is subjected to a cleaning, sterilization, and / or autoclaving cycle in which cleaning fluid is pumped into adapter assembly 200 (possibly under pressure), the cleaning fluid is drained from adapter assembly 200 (possibly under negative pressure), and adapter assembly 200 is heated for a set time and at a set temperature to completely drain the cleaning fluid therefrom. During the sterilization / autoclaving cycle, electronic temperature sensor 312c of adapter assembly 200 monitors temperature and time, and then logs the maximum temperature and / or logs the duration of the sterilization / autoclaving cycle. If the maximum allowable temperature is reached and the sterilization / autoclave cycle has been performed for the minimum time duration, the electronic temperature sensor 312c may record and log the event as a successful sterilization / autoclave cycle, increment its counter, update its log to indicate that a certain number of remaining sterilization / autoclave cycles are available, log that no further sterilization / autoclave cycles are available, and / or log that the sterilization / autoclave cycle was a failed or insufficient cycle.

[0279] Thereafter, when the adapter assembly 200 is connected to the power handle 101, the main controller 147 of the power handle 101 interrogates the electronic temperature sensor 312c, accesses its event log, and activates a signal or display screen 146 commensurate with the information contained in the electronic temperature sensor's 312c event log. For example, the power handle 101 may activate a signal indicating that the adapter assembly 200 is properly sterilized and ready for use, that the adapter assembly 200 is not properly sterilized, or that the adapter assembly 200's life cycle is complete and it cannot be used any further (e.g., disabling use of the power handle 101 and / or adapter assembly 200).

[0280] According to the present disclosure, and referring again to FIG. 82E, after the stapling and cutting sequence is completed, the position of the trocar member 274 is monitored by the main controller 147 of the power handle 101 to prevent the tilted anvil assembly 510 (e.g., the anvil assembly 510 with the head assembly 512 in the titling state) from clamping against the circular refill portion 400, potentially pinching and / or trapping the anastomosed tissue between the head assembly 512 and the circular refill portion 400. In this manner, when power handle 101 is in this "surgical site extraction state" (i.e., after the anastomosis is completed and before the surgical device is removed from the surgical site), and when trocar member 274 (of trocar assembly 270 of adapter assembly 200, see FIGS. 28 and 82E) is positioned such that head assembly 512 of anvil assembly 510 is proximate to refill portion 400 (and may allow tissue to become trapped between tilt head assembly 512 of anvil assembly 510 (see FIG. 23a) and refill portion 400), the force applied to strain gauge assembly 320 (see FIGS. 52-54) is monitored (by main controller 147) to detect whether / when tilt head assembly 512 of anvil assembly 510 is retracted / retracted into refill portion 400.

[0281] Thus, if a predetermined threshold force applied to the strain gauge assembly 320 is exceeded during the "surgical site extraction state" (e.g., as the tilt head assembly 512 is being retracted / retracted into the reloading portion 400) (e.g., by the tilt head assembly 512 pinching or catching tissue against a surface such as the reloading portion 400), the main controller 147 may disable or stop the power handle 101 from further moving the tilt head assembly 512 toward the reloading portion 400, thereby stopping undesirable pinching or catching of tissue between the head assembly 512 and the reloading portion 400. Additionally, it is contemplated that the main controller 147 may activate an audible, visual, and / or tactile alert for the user. As can be appreciated, the main controller 147's entry into the "re-clamp" monitoring state may depend on the relative sizes (e.g., staple size, knife diameter, etc.) of the trocar assembly 270, the center rod assembly 514 and / or the head assembly 512, and the reloading portion 400 attached to the adapter assembly 200.

[0282] Power staplers according to the present disclosure are also configured to enter a recovery state during a clamping, stapling, and cutting sequence if an error is encountered in any of the components, such as the power handle 101, the circular adapter assembly 200, the circular reloader 400, and / or the anvil assembly 510. The recovery state is a software state executed by the main controller 147 that guides the user through correcting and / or troubleshooting the error and allows the user to resume any of the clamping, stapling, and cutting sequences once the error is corrected.

[0283] At the start of each operation sequence (e.g., clamping, stapling, firing, etc.), the main controller 147 writes a recovery code associated with the operation sequence to the storage device 407 of the circular adapter assembly 200. Thus, at the start of a procedure, the storage device 407 stores an initialization recovery code indicating that the circular adapter assembly 200 has not yet been used. However, as the circular adapter assembly 200 is used throughout the procedure, i.e., as the different sequences described above progress, a corresponding recovery code is written to the storage device 407. In addition, the main controller 147 writes a corresponding recovery state to the memory 141. In either case, this allows either the adapter assembly 200 and / or the power handle 101 to be replaced in response to an error condition, at which point both components store their last recovery state locally, i.e., in the storage device 407 or memory 141, respectively.

[0284] 87A and 88A, which illustrate a recovery procedure during a stapling sequence and a cutting sequence, respectively, during the procedure, the power handle 101 may identify a defect in one or more components of the power handle 101, the circular adapter assembly 200, and / or the reloader 400. These recovery procedures are exemplary, and it is envisioned that similar procedures may be implemented in other motion sequences of the power handle 101, such as the clamping sequence. Recovery procedures may include, but are not limited to, attaching a new power handle 101 to the adapter assembly 200 inserted into the patient and replacing the adapter assembly 200 and / or the reloader 400.

[0285] When the adapter assembly 200 is attached to the power handle 101, the power handle 101 reads the recovery code from the storage device 407 to determine the state of the adapter assembly 200. The recovery code was written when the adapter assembly 200 was previously removed from the power handle 101. As described above, at the beginning of a procedure, the recovery code indicates an initial state, which instructs the power handle 101 to proceed to a start-up sequence, e.g., calibration. If the adapter assembly 200 is removed midway through a procedure, e.g., clamping, stapling, or cutting, the corresponding recovery code provides an entry point back into the mainline flow after performing a recovery procedure. This allows the operator to continue the surgical procedure at the point when the adapter assembly 200 was originally removed.

[0286] Similarly, in situations where the power handle 101 is being replaced, the new power handle 101 is configured to read the recovery status from the adapter assembly 200, thereby allowing the new power handle 101 to resume the operation of the previous power handle 101. Thus, during any of the operation sequences, e.g., clamping, stapling, cutting, etc., the adapter assembly 200 can be left in the corresponding configuration, e.g., clamping, stapling, etc., and operation can resume after the new power handle 101 is attached.

[0287] It should be understood that various modifications may be made to the embodiments of the presently disclosed adapter assembly. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

Claims

1. 1. A handheld electromechanical surgical device capable of performing a surgical procedure, comprising: the surgical device comprises a handle assembly, an adapter assembly coupled to and extending from the handle assembly, and a reloader configured to selectively connect to a distal portion of the adapter assembly; The handle assembly includes: Power supply and at least one motor coupled to the power source; a controller configured to control the at least one motor; Including, The adapter assembly includes: a drive assembly; a force transmission and rotation conversion assembly for receiving rotation from the at least one motor of the handle assembly and converting the rotation into axial translation of the drive assembly for the purpose of advancing or retracting the drive assembly; an electrical assembly having a proximal end in communication with the controller of the handle assembly and a distal end; Including, The reloading unit includes: an annular array of a plurality of staples; an annular staple pusher for ejecting the plurality of staples; a knife assembly including an annular knife; a data storage device selectively connectable to the distal end of the electrical assembly of the adapter assembly, the data storage device receiving and storing stapling and / or severing forces of the surgical device from the controller of the handle assembly, the stapling and / or severing forces corresponding to strains measured when the surgical device is used to perform the surgical procedure; 1. A surgical device comprising:

2. 2. The surgical device of claim 1, wherein the reloader includes a shipping cap assembly selectively received on a distal end of the reloader, the shipping cap assembly being present and received on the distal end of the reloader prior to use of the reloader, and the data storage device of the reloader includes information pre-stored therein prior to use of the reloader, the pre-stored information including at least one of a lot number, a staple size, a diameter of the annular knife, a number of uses, or the presence of the shipping cap assembly.

3. 10. The surgical device of claim 1, wherein the data storage device of the reloader is configured such that the stapling force and / or the severing force are written to and stored within the data storage device during or following use of the surgical device.

4. 4. The surgical device of claim 3, wherein the data storage device of the reloader is configured such that following successful or unsuccessful stapling or severing of the reloader of the surgical device, the stapling force and / or the severing force are written to and stored within the data storage device.

5. A surgical device as described in claim 4, wherein the stapling force includes a maximum stapling force corresponding to a maximum strain measured when the surgical device is used to perform stapling, and the cutting force includes a maximum cutting force corresponding to a maximum strain measured when the surgical device is used to perform cutting.

6. A surgical device as described in claim 5, wherein the stapling force and / or the cutting force are written and stored in the controller of the handle assembly.

7. 10. The surgical device of claim 1, wherein the stapling force and / or the severing force of the surgical device are written and stored in the data storage device of the reloader during or following use of the surgical device.

8. 8. The surgical device of claim 7, wherein the data storage device of the reloader includes information pre-stored therein prior to use of the reloader, the pre-stored information including at least one of a lot number, staple size, diameter of the annular knife, number of uses, or presence of the shipping cap assembly.

9. A surgical device as described in claim 8, wherein the stapling force and / or the cutting force are written and stored in the controller of the handle assembly.

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