Patent Description:
Linear clamping, cutting and stapling devices are used in surgical procedures, for example to resect cancerous or anomalous tissue from a gastro-intestinal tract. Conventional clamping, cutting and stapling instruments include a pistol grip-styled structure having an elongated shaft and an end effector having a pair of gripping members disposed at a distal end of the shaft to clamp, cut, and staple tissue. Conventional stapling instruments may also include end effectors having circular stapler attachments. Actuation of the gripping members is usually accomplished by actuating a trigger coupled to the handle, in response to which one of the two gripping members, such as the anvil portion, moves or pivots relative to the elongated shaft while the other gripping element remains fixed. The fixed gripping member includes a staple cartridge and a mechanism for ejecting the staples through the clamped tissue against the anvil portion, thereby stapling the tissue. The end effector may be integrally formed with the shaft or may be detachable allowing for interchangeability of various gripping and stapling members.

A number of surgical device manufacturers have also developed proprietary powered drive systems for operating and/or manipulating the end effectors. The powered drive systems may include a powered handle assembly, which may be reusable, and a disposable end effector that is removably connected to the powered handle assembly.

Many of the existing end effectors for use with existing powered surgical devices and/or handle assemblies are driven by a linear driving force. For example, end effectors for performing endo-gastrointestinal anastomosis procedures, end-to-end anastomosis procedures, and transverse anastomosis procedures, are actuated by a linear driving force. As such, these end effectors are not compatible with surgical devices and/or handle assemblies that use rotary motion.

Thus, there is a need to ensure compatibility between various systems and as well as ensure proper functionality of all of the drive components based on mechanical limitations of the system as a whole.

<CIT> discloses an electromechanical surgical device having a processor configured to run a calibration module.

<CIT> discloses a surgical instrument for applying fasteners includes a drive motor, a replaceable loading unit having an end-effector assembly, and an adapter configured to releaseably couple a replaceable loading unit to the drive motor. The adapter includes a strain gauge having a drive circuit coupled thereto. The strain gauge and the drive circuit are configured to directly measure a driving force in the adapter. The drive circuit includes a microprocessor and factory-calibrated force measurements including slope and offset correction factors are permanently stored in the microprocessor of the drive circuit.

According to one embodiment of the present disclosure, a surgical system includes: an adapter assembly; an end effector configured to couple to a distal portion of the adapter assembly; and a surgical device configured to couple to a proximal portion of the adapter assembly. The surgical device includes: a power source; a motor coupled to the power source, the motor configured to actuate at least one of the adapter assembly or the end effector, the surgical system further includes: a force sensor coupled to at least one of the adapter assembly, the end effector, or the motor, and the force sensor is configured to measure a force imparted on at least one of the adapter assembly, the end effector, or the motor; and a controller operatively coupled to the motor and configured to calibrate the motor based on the measured force while at least one of the adapter assembly or the end effector is actuated by the motor.

According to another aspect of the above embodiment, the force sensor is coupled to the controller and is configured to provide a force measurement signal indicative of the force.

According to a further aspect of the above embodiment, the surgical device further includes a memory coupled to the controller that is configured to store calibration data in the memory based on the force measurement signal. The controller is further configured to operate the motor based on the calibration data.

According to one aspect of the above embodiment, the adapter assembly includes a first storage device, which stores a first value corresponding to operation of the adapter assembly. The controller is further configured to read the first value and to adjust the first value based on the calibration data to obtain an adjusted first value and to operate the motor based on the adjusted first value.

According to another aspect of the above embodiment, the end effector includes a second storage device, which stores a second value corresponding to operation of the adapter assembly. The controller is further configured to read the second value and to adjust the second value based on the calibration data to obtain an adjusted second value and the controller is configured to operate the motor based on the adjusted second value.

According to another embodiment of the present disclosure, a method for controlling a surgical system includes: coupling an adapter assembly to a surgical device; coupling an end effector to the adapter assembly; energizing a motor of the surgical device to actuate at least one of the adapter assembly or the end effector; measuring a parameter associated with actuation of at least one of the adapter assembly or the end effector; and calibrating the motor based on the parameter associated with the actuation of at least one of the adapter assembly or the end effector.

The measurement of the parameter is performed by a force sensor coupled to at least one of the adapter assembly, the end effector, or the motor. The measurement of the parameter includes measuring a force imparted on at least one of the adapter assembly, the end effector, or the motor, the force sensor.

According to another aspect of the above embodiment, the method further includes transmitting a force measurement signal indicative of the force to a controller.

According to a further aspect of the above embodiment, the method further includes storing calibration data in a memory coupled to the controller based on the force measurement signal; operating the motor based on the calibration data; reading a value corresponding to operation of at least one of the end effector or the adapter assembly from a storage device associated with at least one of the end effector or the adapter assembly; and operating the motor based on the value adjusted by the calibration data.

Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:.

Embodiments of the presently disclosed surgical devices and adapter assemblies for use with the surgical devices are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term "distal" refers to that portion of the adapter assembly or surgical device, or component thereof, farther from the user, while the term "proximal" refers to that portion of the adapter assembly or surgical device, or component thereof, closer to the user.

The present disclosure provides a powered surgical device including one or more motors configured to actuate a surgical end effector coupled to the surgical device via an adapter assembly. More specifically, the powered surgical device is configured to couple to an adapter assembly, which in turn, couples to the end effector. One or more force sensors are embedded in one or more of the surgical device, the adapter assembly, and/or the end effector and are configured to monitor the forces imparted on various mechanical components of each of them. The force sensors are configured to provide force measurements to a controller of the surgical device, which then utilizes the measured force to calibrate operation of its motors.

The surgical device according to the present disclosure is configured to monitor the position of various mechanical components, e.g., those of surgical device, the adapter, and the end effector. The powered surgical device is also configured to monitor and react accordingly to forces measured during usage by a force sensor. In particular, the powered surgical device implements an adaptive stapling algorithm executable by the controller in which the surgical device monitors mechanical forces and adjusts the motor speed in response thereto. Execution of the algorithm decreases the motor speed to reduce forces and thus can provide benefits such as improved reliability, better staple formation, and stronger staple lines to reduce leaks. The algorithm may also utilize a shut off force value utilized by the controller to ensure proper functionality of the surgical device without exceeding mechanical limits of the system (e.g., powered surgical device, adapter assembly, and end effector) as a whole.

The powered surgical device according to the present disclosure is also configured to perform force calibration of the powered surgical device, adapter assembly, and/or end effector, which allows for quantifying inherent forces seen within the surgical system that are specific to the components (e.g., adapter assembly and end effector) being used. The measured force is used as a delta factor by the motor control algorithm during the stapling process. The delta factor encompasses variables associated with each of the components of the system, such as the type of the end effector, movement of the end effector, articulation angle, type of tissue, and reloads inclusive of a buttress reinforcement material, and the like. This allows the powered surgical device to incorporate such factors into its motor control algorithm as well as adjust the acceptable force range and/or motor movement based on this factor.

As illustrated in <FIG>, a surgical system <NUM> according to the present disclosure includes a surgical device <NUM>, which is shown as a powered hand held electromechanical instrument, configured for selective attachment to a plurality of different types of end effectors <NUM> having a circular stapler reload <NUM> and anvil <NUM>. In particular, surgical device <NUM> is configured for selective connection with an adapter <NUM>, and, in turn, adapter <NUM> is configured for selective connection with the end effector <NUM>.

<FIG> illustrates another embodiment of a surgical system <NUM>' which also includes the surgical device <NUM> of <FIG>, but utilizes a different type of an adapter <NUM>' that is suitable for use with end effectors <NUM>' or single use loading units ("SULU's"), such as a linear stapler end effectors. Thus, the surgical device <NUM> is configured to operate with a variety of types of end effectors <NUM> or <NUM>' and corresponding adapters <NUM> or <NUM>'.

With reference to <FIG>, surgical device <NUM> includes a power-pack <NUM> (<FIG>), and an outer shell housing <NUM> (<FIG>) configured to selectively receive and enclose the power-pack <NUM>. Outer shell housing <NUM> includes a distal half-section 10a and a proximal half-section 10b. The proximal half-section 10b pivotably connected to distal half-section 10a by a hinge <NUM> located along an upper edge of distal half-section 10a and proximal half-section 10b such that distal and proximal half-sections 10a, 10b are divided along a plane that traverses a longitudinal axis defined by adapter <NUM>. When joined, distal and proximal half-sections 10a, 10b define a shell cavity 10c (<FIG>) for receiving power-pack <NUM>.

With reference to <FIG>, each of distal and proximal half-sections 10a, 10b includes a respective upper shell portion 12a, 12b, and a respective lower shell portion 14a, 14b. Lower shell portion 14a includes a closure tab 18a configured to engage a closure tab 18b of the lower shell portion 14b to selectively secure distal and proximal half-sections 10a, 10b to one another and for maintaining shell housing <NUM> in a closed configuration.

Distal half-section 10a of shell housing <NUM> also includes a connecting portion <NUM> configured to couple to a corresponding drive coupling assembly <NUM> of adapter <NUM> (<FIG>). Specifically, the connecting portion <NUM> includes a recess <NUM> configured to receive a portion of drive coupling assembly <NUM> of adapter <NUM> when adapter <NUM> is mated to surgical device <NUM>. Connecting portion <NUM> of distal half-section 10a also defines three apertures 22a, 22b, 22c and an elongate slot <NUM> formed in a distally facing surface thereof.

Distal half-section 10a of shell housing <NUM> also includes a plurality of buttons such as a toggle control button <NUM>. In embodiments, toggle control button <NUM> may be a two-axis control stick configured to be actuated in a left, right, up and down direction. The toggle control button <NUM> may also be depressible (e.g., along a third axis).

Distal half-section 10a of shell housing <NUM> may also support a plurality of other buttons such as a right-side pair of control buttons and a left-side pair of control button. These buttons and other components are described in detail in <CIT>.

With reference to <FIG>, shell housing <NUM> includes a sterile barrier plate <NUM> removably supported in distal half-section 10a. The sterile barrier plate <NUM> interconnects the power-pack <NUM> and the adapter <NUM>. Specifically, sterile barrier plate <NUM> is disposed behind connecting portion <NUM> of distal half-section 10a and within shell cavity 10c of shell housing <NUM>. Plate <NUM> includes three coupling shafts 64a, 64b, 64c rotatably supported therein. Each coupling shaft 64a, 64b, 64c extends through a respective aperture 22a, 22b, 22c of connecting portion <NUM> of distal half-section 10a of shell housing <NUM>.

Plate <NUM> further includes an electrical pass-through connector <NUM> supported thereon. Pass-through connector <NUM> extends through aperture <NUM> of connecting portion <NUM> of distal half-section 10a when sterile barrier plate <NUM> is disposed within shell cavity 10c of shell housing <NUM>. Coupling shafts 64a, 64b, 64c and pass-through connector <NUM> electrically and mechanically interconnect respective corresponding features of adapter <NUM> and the power-pack <NUM>.

During use, the shell housing <NUM> is opened (i.e., distal half-section 10a is separated from proximal half-section 10b about hinge <NUM>), power-pack <NUM> is inserted into shell cavity 10c of shell housing <NUM>, and distal half-section 10a is pivoted about hinge <NUM> to a closed configuration. In the closed configuration, closure tab 18a of distal half-section 10a engages closure tab 18b of proximal half-section 10b. Following a surgical procedure, shell housing <NUM> is opened and the power-pack <NUM> is removed from shell cavity 10c of shell housing <NUM>. The shell housing <NUM> may be discarded and the power-pack <NUM> may then be disinfected and cleaned.

Referring to <FIG>, power-pack <NUM> includes an inner handle housing <NUM> having a lower housing portion <NUM> and an upper housing portion <NUM> extending from and/or supported on lower housing portion <NUM>. The inner handle housing <NUM> also includes a distal half-section 110a and a proximal half-section 110b, which define an inner housing cavity 110c (<FIG>) for housing a power-pack core assembly <NUM> (<FIG>). Power-pack core assembly <NUM> is configured to control the various operations of surgical device.

With reference to <FIG>, distal half-section 110a of inner handle housing <NUM> supports a distal toggle control interface <NUM> that is operatively engaged with toggle control button <NUM> of shell housing <NUM>, such that when power-pack <NUM> is disposed within shell housing <NUM>, actuation of toggle control button <NUM> exerts a force on toggle control interface <NUM>. Distal half-section 110a of inner handle housing <NUM> also supports various other control interfaces which operatively engage other buttons of shell housing <NUM>.

With reference to <FIG> and <FIG>, power-pack core assembly <NUM> includes a battery circuit <NUM>, a motor controller circuit <NUM>, a main controller circuit <NUM>, a main controller <NUM>, and a rechargeable battery <NUM> configured to supply power to any of the electrical components of surgical device <NUM>. Power-pack core assembly <NUM> further includes a display screen <NUM> supported on main controller circuit <NUM>. Display screen <NUM> is visible through a clear or transparent window 110d disposed in proximal half-section 110b of inner handle housing <NUM>.

Power-pack core assembly <NUM> further includes a first motor <NUM> (<FIG>), a second motor <NUM> (<FIG>), and a third motor <NUM> (<FIG>) each electrically connected to controller circuit <NUM> and battery <NUM>. Motors <NUM>, <NUM>, <NUM> are disposed between motor controller circuit <NUM> and main controller circuit <NUM>. Each motor <NUM>, <NUM>, <NUM> is controlled by a respective motor controller (not shown) that are disposed on motor controller circuit <NUM> and are coupled to a main controller <NUM>. The main controller <NUM> is also coupled to memory <NUM> (<FIG>), which is also disposed on the motor controller circuit <NUM>. The main controller <NUM> communicates with the motor controllers through an FPGA, which provides control logic signals (e.g., coast, brake, etc. and any other suitable control signals). The motor controllers output corresponding energization signals to their respective motors <NUM>, <NUM>, <NUM> using fixed-frequency pulse width modulation (PWM) or any other suitable control signals.

Power-pack core assembly <NUM> also includes an electrical receptacle <NUM>. Electrical receptacle <NUM> is in electrical connection with main controller board <NUM> via a second ribbon cable (not shown). Electrical receptacle <NUM> defines a plurality of electrical slots for receiving respective electrical contacts extending from pass-through connector <NUM> of plate <NUM> (<FIG>) of shell housing <NUM>.

Each motor <NUM>, <NUM>, <NUM> includes a respective motor shaft 152a, 152b, 152c extending therefrom. Each motor shaft 152a, 152b, 152c may have a recess defined therein having a tri-lobe transverse cross-sectional profile for receiving proximal ends of respective coupling shaft 64a, 64b, 64c of plate <NUM> of shell housing <NUM>.

Rotation of motor shafts 152a, 152b, 152c by respective motors <NUM>, <NUM>, <NUM> actuates shafts and/or gear components of adapter <NUM> in order to perform various operations of surgical device <NUM>. In particular, motors <NUM>, <NUM>, <NUM> of power-pack core assembly <NUM> are configured to actuate shafts and/or gear components of adapter <NUM> in order to selectively actuate components of the end effector <NUM>, to rotate end effector <NUM> about a longitudinal axis, and to pivot the end effector <NUM> about a pivot axis perpendicular to the longitudinal axis defined by the adapter <NUM>.

With reference to <FIG> and <FIG>, the adapter <NUM> includes an outer knob housing <NUM> and an outer tube <NUM> extending from a distal end of knob housing <NUM>. Knob housing <NUM> is configured and adapted to connect to connecting portion <NUM> of shell housing <NUM> of surgical device <NUM> via the drive coupling assembly <NUM> as described above. The outer tube <NUM> is configured for selective connection with the end effector <NUM> (<FIG>).

The drive coupling assembly <NUM> extends proximally from the knob housing <NUM> and includes a plurality of rotatable connector sleeves <NUM>, <NUM>, <NUM>. The drive coupling assembly <NUM> is configured to couple to the recess <NUM> of the connecting portion <NUM> of the shell housing <NUM>. The adapter <NUM>' is configured to couple to the surgical device <NUM> in a similar manner. A connector <NUM> of the adapter assembly <NUM> is configured to mate with the pass-through connector <NUM> of the surgical device <NUM>. Once the adapter <NUM> is mated to the surgical device <NUM>, the coupling shafts 64a, 64b, 64c of the surgical device <NUM> engage the corresponding rotatable connector sleeves <NUM>, <NUM>, <NUM>. Each of connector sleeves <NUM>, <NUM>, <NUM> is configured to interconnect respective first, second and third coupling shafts 64a, 64b, 64c of surgical device <NUM> with respective proximal drive shafts (not shown) of adapter <NUM>. Each of the proximal drive shafts is configured to actuate various components of the adapter <NUM>, the end effector <NUM>, and/or the anvil <NUM>.

With reference to <FIG>, the connector sleeve <NUM> is coupled to a rotatable proximal drive shaft <NUM>, which is in turn coupled to a second rotatable drive shaft <NUM>, that is coupled to a trocar assembly <NUM>. For brevity only the mechanical linkages coupled to the connector sleeve <NUM> are shown. The trocar assembly <NUM> is selectively couplable to a trocar member <NUM> or the anvil assembly <NUM>. The adapter <NUM> also includes a force sensor <NUM> disposed in support block <NUM> that is fixedly coupled within the outer tube <NUM>. The force sensor <NUM> is configured to measure and monitor forces imparted on the trocar member <NUM> during extension and retraction thereof. In addition, the force sensor <NUM> is also configured to monitor forces imparted on any other movable components of the adapter <NUM> that are mechanically coupled to the force sensor <NUM>. The force sensor <NUM> is coupled to the main controller <NUM> of the surgical device <NUM> using a wired or a wireless connection. A wired connection may be any suitable wired interface (e.g., <NUM>-wire) through the connector <NUM> and the pass-through connector <NUM>. Wireless connection may be implemented any suitable electromagnetic wave communication protocol, such as BLUETOOTH®, near-field communication protocols, radio-frequency identification protocols, and the like. In embodiments, the force sensor <NUM> may be disposed within the adapter assembly <NUM>', the end effectors <NUM> or <NUM>', and/or the surgical device <NUM>.

With reference to <FIG>, a schematic diagram of the power-pack <NUM> is shown. For brevity, only one of the motors <NUM>, <NUM>, <NUM> is shown, namely, motor <NUM>. The motor <NUM> is coupled to the battery <NUM>. In embodiments, the motor <NUM> may be coupled to any suitable power source configured to provide electrical energy to the motor <NUM>, such as an AC/DC transformer.

The battery <NUM> and the motor <NUM> are coupled to the motor controller circuit <NUM> which controls the operation of the motor <NUM> including the flow of electrical energy from the battery <NUM> to the motor <NUM>. The motor controller circuit <NUM> includes a plurality of sensors 408a, 408b,. 408n configured to measure operational states of the motor <NUM>, the battery <NUM>, or any other components of the system <NUM>. The sensors 408a-n may include the force sensor <NUM>, voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n may measure voltage, current, and other electrical properties of the electrical energy supplied by the battery <NUM>. The sensors 408a-408n may also measure angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operational properties of the motor <NUM>. Angular velocity may be determined by measuring the rotation of the motor <NUM> or a drive shaft (not shown) coupled thereto and rotatable by the motor <NUM>. Position of various axially movable drive shafts may also be determined by using various linear sensors disposed in or in proximity to the shafts or extrapolated from the RPM measurements. In embodiments, torque may be calculated based on the regulated current draw of the motor <NUM> at a constant RPM. In further embodiments, the motor controller circuit <NUM> and/or the controller <NUM> may measure time and process the above-described values as a function thereof, including integration and/or differentiation, e.g., to determine the rate of change in the measured values.

The motor controller circuit <NUM> is also coupled to the controller <NUM>, which includes a plurality of inputs and outputs for interfacing with the motor controller circuit <NUM>. In particular, the controller <NUM> receives measured sensor signals from the motor controller circuit <NUM> regarding operational status of the motor <NUM> and the battery <NUM> and, in turn, outputs control signals to the motor controller circuit <NUM> to control the operation of the motor <NUM> based on the sensor readings and specific algorithm instructions, which are discussed in more detail below. The controller <NUM> is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc. coupled to the controller <NUM>).

With reference to <FIG>, <FIG>, and <FIG>, each of the end effectors <NUM> or <NUM>' include a storage device <NUM> which stores data pertaining to the end effector <NUM> or <NUM>', respectively. The storage device <NUM> may include non-volatile storage medium (e.g., EEPROM) that is configured to store any data pertaining to the end effector <NUM> or <NUM>', including but not limited to, usage count, identification information, model number, serial number, staple size, stroke length, maximum actuation force, minimum actuation force, factory calibration data, and the like.

With continued reference to <FIG> and <FIG>, each of the adapters <NUM> and <NUM>' also include a storage device <NUM>, similar to the storage device <NUM>. The storage device <NUM> is configured to store any data pertaining to the adapters <NUM> and <NUM>', including but not limited to, designation of which of the rotatable connector sleeves <NUM>, <NUM>, <NUM> correspond to specific functions of the end effector <NUM> or <NUM>' (e.g., mapping connector sleeves <NUM>, <NUM>, <NUM> to functions), usage count, identification information, model number, serial number, identification information, model number, serial number, maximum and/or minimum actuation force for each of the rotatable connector sleeves <NUM>, <NUM>, <NUM>, factory calibration data, and the like.

The storage devices <NUM> and <NUM> are configured to communicate with the main controller <NUM> of the surgical device <NUM> using a wired or a wireless connection. A wired connection may be any suitable wired interface (e.g., <NUM>-wire) through the connector <NUM> and the pass-through connector <NUM>. In embodiments, the storage devices <NUM> and <NUM> may also be used to authenticate the attached component, e.g., the adapter <NUM> or <NUM>', the end effector <NUM> or <NUM>'.

The present disclosure provides for an apparatus and method for controlling the surgical device <NUM> or any other powered surgical instrument, including, but not limited to, linear powered staplers, circular or arcuate powered staplers, graspers, electrosurgical sealing forceps, rotary tissue morcellating devices, and the like. In particular, the surgical device <NUM> is configured to adjust the speed of the motor <NUM> based on force measurements, including calibration, from the force sensor <NUM>. The force feedback may be utilized during any operation of the motor <NUM>, e.g., whether the motor <NUM> is actuating articulation of the end effector <NUM>', ejecting staples from the end effector <NUM> or <NUM>', moving the anvil <NUM>, etc. In addition, to using continuous force feedback during operation of the motor <NUM>, the surgical device <NUM> is also configured to calibrate the motor <NUM> based on the adapter <NUM> or <NUM>'along with the end effector <NUM> or <NUM>' to account for inherent mechanical losses associated with each individual component attached to the surgical device <NUM> (e.g., adapter <NUM> or <NUM>', the end effector <NUM> or <NUM>'). In embodiments, the surgical device <NUM> may also utilize calibration data stored on the storage device <NUM> and/or storage device <NUM>. The calibration data may be used in conjunction with force calibration performed by the surgical device <NUM> as described in further detail below.

<FIG> shows a method according to the present disclosure of operating the surgical device <NUM>. The method is described below with respect to the adapter <NUM> and the end effector <NUM>, but is applicable with respect to adapter <NUM>' and the end effector <NUM>' or any other suitable attachments. Initially, the adapter <NUM> is coupled to the surgical device <NUM>. The surgical device <NUM>, and namely, main controller <NUM> verifies that the adapter <NUM> is authentic based on the data stored on the storage device <NUM>. After verification, the main controller <NUM> may also read additional data from the storage device <NUM>, such as calibration data, maximum actuation force data, etc..

The main controller <NUM> commences a first calibration process for the adapter <NUM>. This includes actuating each of the coupling shafts 64a, 64b, 64c to rotate connector sleeves <NUM>, <NUM>, <NUM> and their corresponding drive trains. While each of the connector sleeves <NUM>, <NUM>, <NUM> are actuated, the force sensor <NUM> measures force imparted on the drive trains. Calibration may include obtaining a reference force measurement while driving the connector sleeves <NUM>, <NUM>, <NUM> in a first direction until their respective mechanical limits are reached and then returning the connector sleeves <NUM>, <NUM>, <NUM> back to their starting position or until another mechanical limit is reached. In embodiments, each or all of the connector sleeves <NUM>, <NUM>, <NUM> may be calibrated. The encountered force for each of the mechanical limits of the connector sleeves <NUM>, <NUM>, <NUM> is stored in the memory <NUM>. In addition, the main controller <NUM> also records the force imparted on the drive trains of the adapter <NUM> for the duration of calibration, namely, the force associated while the connector sleeves <NUM>, <NUM>, <NUM> are actuated between mechanical limits. Since the adapter <NUM> is not acting on any mechanical loads, e.g., the end effector <NUM> and/or tissue, the measured force corresponds to the force required to drive only the components of the adapter <NUM>, which is stored as a first (e.g., adapter) force calibration data.

After the calibration of the adapter <NUM>, the end effector <NUM> is coupled to the adapter <NUM>. The surgical device <NUM>, and namely, main controller <NUM> verifies that the end effector <NUM> is authentic based on the data stored on the storage device <NUM>. After verification, the main controller <NUM> may also read additional data from the storage device <NUM>, such as calibration data, maximum actuation force data, etc..

The main controller <NUM> commences a second calibration process for the end effector <NUM> and/or the anvil <NUM>. This includes actuating each of the coupling shafts 64a, 64b, 64c to rotate connector sleeves <NUM>, <NUM>, <NUM> and their corresponding drive trains while the end effector <NUM> and/or the anvil <NUM> are attached to the adapter <NUM>. While each of the connector sleeves <NUM>, <NUM>, <NUM> are actuated, the force sensor <NUM> measures the forces imparted on the drive trains while actuating the end effector <NUM> and/or the anvil <NUM>. Calibration may include obtaining reference force measurements while driving the connector sleeves <NUM>, <NUM>, <NUM> in a first direction until mechanical limits of the end effector <NUM> and/or the anvil <NUM> are reached and then returning the articulation shaft back to the starting position or until another mechanical limit is reached. The encountered force for each of the mechanical limits is stored in the memory <NUM>. In addition, the main controller <NUM> also records the force imparted on the drive trains of the adapter <NUM> for the duration of calibration, namely, the force associated while the end effector <NUM> and/or the anvil <NUM> are actuated between mechanical limits. Since during the second calibration the adapter <NUM> is actuating the end effector <NUM> and/or the anvil <NUM>, the measured force corresponds to the combined force that is used to drive various components of the adapter <NUM> as well as those of the end effector <NUM> and/or the anvil <NUM>, which is stored as a second (e.g., combined) force calibration data.

In embodiments, the first and second calibration processes may be performed as a single sequence, namely, the first calibration may be omitted and combined with the second calibration, such that a single calibration occurs after the adapter <NUM> is coupled to the surgical device <NUM>, and the end effector <NUM> with the anvil <NUM> is coupled to the adapter <NUM>) to obtain the combined force calibration data. In further embodiments, the controller <NUM> may determine the calibration data for the end effector <NUM> and/or the anvil <NUM> based on the difference between the first and second calibration data.

The controller <NUM> also uses the first and/or second force calibration data to adjust values loaded from the storage device <NUM> and/or <NUM>. In addition to the values loaded from the storage device <NUM> and/or <NUM>, the controller <NUM> also uses the first and/or second force calibration data to adjust threshold values stored in memory <NUM>. Each of the individual sequences (e.g., cutting, stapling, articulation, etc.) may include a plurality of corresponding force threshold values. The threshold values are stored in the memory <NUM> and are used by the controller <NUM> to control each of the sequences. One of the threshold values may be a maximum force value beyond which operation of the motor <NUM> may result in damage to the surgical device <NUM>, the adapter <NUM>, end effector <NUM>, and/or anvil <NUM>. In embodiments, each one of these components may have its own individual maximum threshold force value that may be stored in the storage device <NUM> or <NUM>, respectively, and read by the controller <NUM> as described above.

The controller <NUM> uses the measured first and/or second calibration data to adjust the stored threshold values in memory <NUM>. Adjustment of threshold values may include using the calibration data to derive offset values, which are then used to modify the threshold values. Offset values derived from the calibration data may then be used to adjust the threshold values by using any suitable mathematical function defining the relationship between calibration data and threshold values.

Once calibration is performed and the threshold values are updated based on the first and and/or second calibration data, the system <NUM> may be used to perform the surgical procedure. The motor <NUM> is energized to actuate various components of the adapter <NUM> as well as the end effector <NUM> and/or anvil <NUM> based on user's input commands. During operation, the force is continuously measured by the force sensor <NUM>. The collected force data is utilized to control the stapling, cutting, articulation, and any other sequences that the surgical device <NUM> is programmed to perform. In embodiments, the force thresholds may be used to execute specific functions and/or subsequences used during certain operational sequences, such as a first threshold may be used to determine whether a clamping sequence is complete, a second threshold may be used to determine if a stapling sequence is complete, and a third threshold may be used to determine if a cutting sequence is complete.

In embodiments, the controller <NUM> may also continuously compare measured force from the force sensor <NUM> such that it does not exceed the maximum force threshold. The maximum force threshold is continuously monitored by the controller <NUM> based on the feedback from the force sensor <NUM>. This acts as a so-called "watchdog" function to ensure safe functionality of the system <NUM>. Thus, if the maximum threshold is exceeded, the controller <NUM> terminates the operational sequence by cutting off supply of electrical current to the motor <NUM> and/or notifying the user of the error.

Claim 1:
A surgical system (<NUM>) comprising:
an adapter assembly (<NUM>, <NUM>');
an end effector (<NUM>, <NUM>') configured to couple to a distal portion of the adapter assembly; and
a surgical device (<NUM>) configured to couple to a proximal portion of the adapter assembly, the surgical device including:
a power source (<NUM>);
a motor (<NUM>) coupled to the power source, the motor configured to actuate at least one of the adapter assembly or the end effector;
a force sensor (<NUM>) coupled to at least one of the adapter assembly, the end effector, or the motor, the force sensor configured to measure a force imparted on at least one of the adapter assembly, the end effector, or the motor; and
a controller (<NUM>) operatively coupled to the motor, characterised in that the controller is configured to calibrate the motor based on the measured force from said force sensor while at least one of the adapter assembly or the end effector is actuated by the motor.