Patent ID: 12213674

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical devices, and adapter assemblies for surgical devices and/or handle assemblies 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 surgical instrument, or component thereof, farther from the user, while the term “proximal” refers to that portion of the surgical instrument, or component thereof, closer to the user.

The present disclosure provides a powered circular stapler10having a handle assembly, an adapter assembly coupled to the handle assembly, and an end effector coupled to the adapter assembly. The stapler allows for full, independent control of three functions: clamping, stapling, and cutting.FIG.1illustrates a surgical device, such as, for example, a powered circular stapler10for forming end-to-end anastomosis (“EEA”), including a handle assembly100, which is configured for selective connection with an adapter assembly200. The adapter assembly200is configured for selective connection with an end effector300, which includes a reload400and an anvil assembly500. The end effector300is configured to produce a surgical effect on tissue of a patient, namely, forming an anastomosis by connecting two portions of a structure (e.g., intestine, colon, etc.) by clamping, stapling, and cutting tissue grasped within the end effector300.

The handle assembly100includes a power handle101and an outer shell housing11configured to selectively receive and encase power handle101. The shell housing11includes a distal half-section11aand a proximal half-section11bpivotably connected to distal half-section11a. When joined, distal and proximal half-sections11a,11bdefine a shell cavity therein in which power handle101is disposed.

While the powered circular stapler10is described herein as a modular device including a plurality of interconnected components, such as the handle assembly100, the removable shell housing11, and the adapter assembly200, etc. The powered circular stapler10may be formed as an integrated device with one or more of the components being securely attached to each other, e.g., during manufacturing of the powered circular stapler.

Distal and proximal half-sections11a,11bof shell housing11are divided along a plane that traverses a longitudinal axis “X” of adapter assembly200. Distal half-section11aof shell housing11defines a connecting portion20configured to accept a corresponding drive coupling assembly210(FIG.3) of adapter assembly200. Distal half-section11aof shell housing11supports a toggle control button30. Toggle control button30is capable of being actuated in four directions (e.g., a left, right, up and down).

With reference toFIGS.1and2, the power handle101includes a main controller circuit board142, a rechargeable battery144configured to supply power to any of the electrical components of handle assembly100, and a plurality of motors, i.e., a first motor152a, a second motor152bcoupled to the battery144. The power handle101also includes a display146. In embodiments, the motors152aand152bmay be coupled to any suitable power source configured to provide electrical energy to the motors152aand152b, such as an AC/DC transformer. Each of the motors152aand152bis coupled a motor controller143which controls the operation of the corresponding motors152aand152bincluding the flow of electrical energy from the battery144to the motors152aand152b. A main controller147is provided that controls the power handle101. The main controller147is configured to execute software instructions embodying algorithms disclosed herein, such as clamping, stapling, and cutting algorithms which control operation of the power handle101.

The motor controller143includes a plurality of sensors408a. . .408nconfigured to measure operational states of the motors152aand152band the battery144. The sensors408a-ninclude a strain gauge408band may also include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors408a-408nmay measure voltage, current, and other electrical properties of the electrical energy supplied by the battery144. The sensors408a-408nmay also measure angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operational properties of the motors152aand152b. The sensor408aalso includes an encoder configured to count revolutions or other indicators of the motors152aand152b, which is then used by the main controller147to calculate linear movement of components movable by the motors152aand152b. Angular velocity may be determined by measuring the rotation of the motors152aand152bor a drive shaft (not shown) coupled thereto and rotatable by the motors152aand152b. The 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 motors152aand152bat a constant RPM. In further embodiments, the motor controller143and/or the main controller147may measure time and process the above-described values as a function of time, including integration and/or differentiation, e.g., to determine the rate of change in the measured values. The main controller147is also configured to determine distance traveled of various components of the adapter assembly200and/or the end effector300by counting revolutions of the motors152aand152b.

The motor controller143is coupled to the main controller147, which includes a plurality of inputs and outputs for interfacing with the motor controller143. In particular, the main controller147receives measured sensor signals from the motor controller143regarding operational status of the motors152aand152band the battery144and, in turn, outputs control signals to the motor controller143to control the operation of the motors152aand152bbased on the sensor readings and specific algorithm instructions. The main controller147is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc. coupled to the main controller147).

The main controller147is also coupled to a memory141. The memory141may include volatile (e.g., RAM) and non-volatile storage configured to store data, including software instructions for operating the power handle101. The main controller147is also coupled to the strain gauge408bof the adapter assembly200using a wired or a wireless connection and is configured to receive strain measurements from the strain gauge408bwhich are used during operation of the power handle101.

The power handle101includes a plurality of motors152aand152beach including a respective motor shaft (not explicitly shown) extending therefrom and configured to drive a respective transmission assembly. Rotation of the motor shafts by the respective motors function to drive shafts and/or gear components of adapter assembly200in order to perform the various operations of handle assembly100. In particular, motors152aand152bof power handle101are configured to drive shafts and/or gear components of adapter assembly200in order to selectively extend/retract a trocar member274(FIG.4) of a trocar assembly270of adapter assembly200. Extension/retraction of the trocar member274opens/closes end effector300(when anvil assembly500is connected to trocar member274of trocar assembly270), fire an annular array of staples423of reload400, and move an annular knife444of reload400.

Turning now toFIGS.3and4, adapter assembly200includes an outer knob housing202and an outer tube206extending from a distal end of knob housing202. Knob housing202and outer tube206are configured and dimensioned to house the components of adapter assembly200. The knob housing202includes an electrical connector312and a storage device310coupled thereto. The storage device310is configured to store various operating parameters pertaining to the adapter assembly200. Adapter assembly200is configured to convert rotation of coupling shafts (not explicitly shown) of handle assembly100into axial translations useful for operating trocar assembly270of adapter assembly200, anvil assembly500, and/or staple driver430or knife assembly440of reload400.

Adapter assembly200further includes the trocar assembly270removably supported in a distal end of outer tube206. Trocar assembly270includes a trocar member274and a drive screw276operably received within trocar member274for axially moving trocar member274relative to outer tube206. A distal end274bof trocar member274is configured to selectively engage anvil assembly500, such that axial movement of trocar member274, via a rotation of drive screw276, results in a concomitant axial movement of anvil assembly500.

With reference toFIG.4, a clamping transmission assembly240includes first rotatable proximal drive shaft212coupled to one of the motors152aand152b, a second rotatable proximal drive shaft281, a rotatable distal drive shaft282, and a coupling member286, each of which are supported within the outer tube206of adapter assembly200. Clamping transmission assembly240functions to extend/retract trocar member274of trocar assembly270of adapter assembly200, and to open/close the anvil assembly510when anvil assembly510is connected to trocar member274.

With reference toFIG.5, the adapter assembly200includes a stapling transmission assembly250for interconnecting the first motor152aand a second axially translatable drive member of reload400, wherein the stapling transmission assembly250converts and transmits a rotation of the first motor152ato an axial translation of an outer flexible band assembly255of adapter assembly200, and in turn, the staple driver430of reload400to fire staples423from the reload400and against anvil assembly510.

The stapling transmission assembly250of adapter assembly200includes the outer flexible band assembly255secured to staple driver coupler254. A second rotatable proximal drive shaft220is coupled to the second motor152band is configured to actuate that staple driver coupler254, which converts rotational movement into longitudinal movement. Outer flexible band assembly255includes first and second flexible bands255a,255blaterally spaced and connected at proximal ends thereof to a support ring255cand at distal ends thereof to a proximal end of a distal pusher255d. Each of first and second flexible bands255a,255bis attached to support ring255cand distal pusher255d. Outer flexible band assembly255further includes first and second connection extensions255e,255fextending proximally from support ring255c. First and second connection extensions255e,255fare configured to operably connect outer flexible band assembly255to staple driver coupler254of stapling transmission assembly250.

The adapter assembly200also includes a cutting transmission assembly260for interconnecting the second motor152band the annular knife444of reload400, wherein the cutting transmission assembly260converts and transmits a rotation of one of the second motor152bto an axial translation of an outer flexible band assembly265of adapter assembly200, and in turn, a knife carrier442of reload400to advance the annular knife444from the reload400and against anvil assembly510.

Inner flexible band assembly265includes first and second flexible bands265a,265blaterally spaced and connected at proximal ends thereof to a support ring265cand at distal ends thereof to a proximal end of a support base265d. Each of first and second flexible bands265a,265bare attached to support ring265cand support base265d.

Inner flexible band assembly265further includes first and second connection extensions265e,265fextending proximally from support ring265c. First and second connection extensions265e,265fare configured to operably connect inner flexible band assembly265to knife driver264of cutting transmission assembly260. Support base265dextends distally from flexible bands265a,265band is configured to connect with a knife assembly440of reload400.

With reference toFIG.7, staple driver430of reload400includes a staple cartridge420having a driver adapter432and a driver434. A proximal end432aof driver adapter432is configured for selective contact and abutment with distal pusher255dof outer flexible band assembly255of stapling transmission assembly250of adapter assembly200. In operation, during distal advancement of outer flexible band assembly255, as described above, distal pusher255dof outer flexible band assembly255contacts proximal end432aof driver adapter432to advance driver adapter432and driver434from a first or proximal position to a second or distal position. Driver434includes a plurality of driver members436aligned with staple pockets421of staple cartridge420for contact with staples423. Accordingly, advancement of driver434relative to staple cartridge420causes ejection of the staples423from staple cartridge420.

The knife assembly440of the reload400includes a knife carrier442and an annular knife444secured about a distal end442bof knife carrier442. A proximal end442aof knife carrier442is configured to engage the support base265dof inner flexible band assembly. In operation, during distal advancement of inner flexible band assembly265, support base265dof inner flexible band assembly265connects with proximal end442aof knife carrier442to advance knife carrier442and annular knife444from a first or proximal position to a second or advanced position to cause the cutting of tissue disposed between staple cartridge420and anvil assembly510.

Forces during an actuation of trocar member274, closing of end effector300(e.g., a retraction of anvil assembly500relative to reload400), ejecting staples423from the reload400, and advancement of the knife assembly440may be measured by the strain gauge408bin order to monitor and control various processes, such as firing of staples423from reload400; monitor forces during a firing and formation of the staples423as the staples423are being ejected from reload400; optimize formation of the staples423(e.g., staple crimp height) as the staples423are being ejected from reload400for different indications of tissue; and monitor and control a firing of the annular knife of reload400.

With reference toFIG.8, the strain gauge408bof adapter assembly200is disposed within a strain gauge housing320. The strain gauge408bmeasures and monitors the retraction of trocar member274as well as the ejection and formation of the staples423from the reload400. During the closing of end effector300, when anvil assembly500contacts tissue, an obstruction, a tissue-contacting surface of the reload400, staple ejection, or the like, a reaction force is exerted on anvil assembly500which is in a generally distal direction. This distally directed reaction force is communicated from anvil assembly500to the strain gauge408b. The strain gauge408bthen communicates signals to main controller circuit board142of power handle101of handle assembly100. Graphics (FIG.8) are then displayed on the display146of handle assembly100to provide the user with real-time information related to the status of the firing of handle assembly100.

The trocar assembly270is axially and rotationally fixed within outer tube206of adapter assembly200. With reference toFIG.8, adapter assembly200includes a support block292fixedly disposed within outer tube206. The strain gauge housing320is disposed between the support block292and a connector sleeve290. The reload400is removably coupled to the connector sleeve290.

In operation, strain gauge408bof adapter assembly200measures and monitors the retraction of trocar member274, which passes through the strain gauge408b. The strain gauge408bof adapter assembly200also measures and monitors ejection of the staples423from the reload400, since the first and second flexible bands255a,255balso pass through the strain gauge408b. During clamping, stapling and cutting, a reaction force is exerted on anvil assembly500and the reload400, which is communicated to support block292, which then communicates the reaction force to a strain sensor of the strain gauge408b.

Strain sensor of strain gauge408bmay be any device configured to measure strain (a dimensionless quantity) on an object that it is adhered to (e.g., support block292), such that, as the object deforms, a metallic foil of the strain sensor is also deformed, causing an electrical resistance thereof to change, which change in resistance is then used to calculate loads experienced by trocar assembly270. Strain gauge408bprovides a closed-loop feedback to a firing/clamping load exhibited by first, second and third force/rotation transmitting/converting assemblies.

Strain sensor of strain gauge408bthen communicates signals to main controller circuit board142. Graphics are then displayed on display146of power-pack core assembly106of handle assembly100to provide the user with real-time information related to the status of the firing of handle assembly100. Strain gauge408bis also electrically connected to the electrical connector312(FIG.3) via proximal and distal harness assemblies314,316.

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

The reload400includes a storage device402and the circular adapter assembly200also includes a storage device310(FIG.4). The storage devices402and310include non-volatile storage medium (e.g., EEPROM) that is configured to store any data pertaining to the reload400and the circular adapter assembly200, respectively, 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. In embodiments, the data may be encrypted and is only decryptable by devices (e.g., main controller147) having appropriate keys. The data may also be used by the main controller147to authenticate the circular adapter assembly200and/or the reload400. The storage devices402and310may be configured in read only or read/write modes, allowing the main controller147to read as well as write data onto the storage device402and310.

Prior to operation of the powered circular stapler10, the power handle101is enclosed within the shell housing11the adapter assembly200is coupled to handle assembly100. After attachment of circular adapter assembly200, handle assembly100initially verifies that circular adapter assembly200is coupled thereto by establishing communications with the storage device310of the circular adapter assembly200and authenticates circular adapter assembly200. The data (e.g., usage count) stored on the storage device310is encrypted and is authenticated by the power handle101prior to determining whether the usage count stored on the storage device310exceeds the threshold (e.g., if the adapter assembly200has been previously used). Power handle101then performs verification checks (e.g., end of life checks, trocar member274missing, etc.) and calibrates circular adapter assembly200after the handle assembly100confirms that the trocar member274is attached.

With reference toFIG.9a method for determining whether the staples423of the reload400have been previously ejected includes, at step600, the main controller147receiving a staple home position value, e.g., by reading from the storage device310, and calculating other staple position reference values, such as calibration position. At step602, the main controller147also compares the staple home position value read from the storage device310to the maximum and minimum values stored in the memory141. If the value is outside the range, at step604, an error screen is displayed and the power handle101transitions to a lock up state, preventing use of the adapter assembly200. The absolute minimum value is set at 0.0 turns for the first motor152a.

If the staple home position value is within the expected absolute values, the adapter assembly200may be used and the reload400is coupled to circular adapter assembly200. At step606, the handle assembly100verifies that reload400is attached to circular adapter assembly200by establishing communications with the storage device402of reload400.

At step608, the power handle101authenticates the storage device402and confirms that circular reload400has not been previously fired by checking the usage count. The usage count is adjusted and encoded by handle assembly100after use of reload400. If circular reload400has been previously used, handle assembly100displays an error indicating the same on the display screen146.

At step610, the power handle101performs a staple calibration process including moving stapling transmission assembly250distally for a short period of time (e.g., about 200 milliseconds) to move the stapling transmission assembly250off a hard stop position700(FIG.10), which is a proximal mechanical limit. This is done for the purpose of moving the stapling transmission assembly250off the hard stop position700in the event that the stapling transmission assembly250is already pinned against the hard stop position700.

At step612, the stapling transmission assembly250is moved proximally by the first motor152ato the hard stop position700to establish a zero-position reference point. The stapling transmission assembly250may be disposed at any distance away from the hard stop position700. However, if the distance is too large, then the stapling transmission assembly250may inadvertently push out the staples423of the reload400. The following steps determine whether the staples423have been previously ejected, by checking the distance travelled by the stapling transmission assembly250to the hard stop position700.

At step614, the main controller147calculates the distance travelled by the stapling transmission assembly250, i.e., by monitoring rotations of the first motor152a. The first motor152amoves the stapling transmission assembly250until a specified current limit is detected indicative of the stapling transmission assembly250hitting the hard stop position700.

At step616, the main controller147also monitors the current draw of the movement. At step618, the main controller147compares the measured current draw to a current limit, and if the current limit is exceeded before reaching the hard stop position700due to a mechanical malfunction, e.g., broken gears, motor, etc., the main controller147exits calibration and outputs an error message at step604and/or requests a new adapter assembly200and/or handle assembly100.

The main controller147also monitors the time during the movement, and if the motor movement times-out (e.g., 5-20 seconds), due to a mechanical malfunction, e.g., broken gears, motor, etc. At step620, the main controller147continuously checks if a time out has occurred, and if the time limit is exceeded before the hard stop is reached, the main controller147exits calibration and outputs an error message at step604and/or requests a new adapter assembly200and/or handle assembly100.

At step622, the main controller147utilizes the traveled distance during calibration to confirm that the reload400is unused. Thus, if the traveled distance is determined to be above a predetermined hard stop threshold, then the main controller147confirms that the staples423were previously ejected from the reload400and at step624marks the reload400as used, regardless of the previous status of the reload400. The main controller147exits calibration and may output an error message and/or requests a new reload400.

At step626, the calibration is successfully completed once the hard stop position700is reached within the predetermined time, without exceeding time, current, and distance thresholds.

It will be understood that various modifications may be made to the embodiments of the presently disclosed circular staplers. Therefore, 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.

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

Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.