This disclosure relates generally to powered surgical stapling instruments, and more particularly, to a method for controlling surgical stapling instruments based upon staple formation range and to a surgical stapling instrument for performing the method.
Anastomosis is the surgical joining of separate hollow organ sections. Typically, an anastomosis procedure follows surgery in which a diseased or defective section of an organ is removed, and the remaining end sections of the organ are joined via a surgical stapling instrument. Depending on the desired anastomosis procedure, the remaining end sections may be joined by circular or side-to-side organ reconstruction methods, for instance.
In a circular anastomosis procedure, the remaining end sections of the organ are joined by means of a surgical stapling instrument which drives a circular array of staples through the remaining end sections and simultaneously cores any tissue interior of the driven circular array of staples to free a tubular passage within the organ. Staples delivered during the circular anastomosis procedure should be formed such that the contents of the gastrointestinal tracts do not leak into the abdominal or thoracic cavity.
A continuing need exists for a stapling instrument that can distinguish between staple formations that may prevent leaks and staple formations that are not sufficiently closed.
In accordance with the disclosure, a computer-implemented method for controlling a surgical stapling instrument for stapling tissue includes advancing a pusher towards an anvil assembly of the surgical stapling instrument from a first position to a second position, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument, determining whether the pusher stopped advancing towards the anvil assembly prior to the second position, measuring a force of staple compression of a staple being ejected from the staple cartridge by the pusher, and determining if the force of staple compression is outside of a predetermined range.
In an aspect, the method further includes entering a tissue cutting mode of the surgical stapling instrument in response to the force of staple compression based on a predetermined acceptable range of staple compression.
In another aspect, the force of staple compression may be measured by a strain gauge.
In yet another aspect, the force of staple compression may be measured based on a current of a motor configured to advance the pusher.
In an aspect, the method may further include preventing staple firing in response to the force of staple compression being greater than the predetermined range.
In another aspect, the method may further include displaying a warning in response to the force of staple compression being greater than the predetermined range.
In yet another aspect, the displayed warning may include a warning to inspect a surgical site and/or to unclamp tissue.
In still yet another aspect, the method may further include retracting the pusher.
In still yet another aspect, the method may further include generating an audio warning in response to the force of staple compression being greater than the predetermined range.
In still yet another aspect, the method may further include determining whether a functionally closed staple formation has been achieved.
In accordance with aspects of the disclosure, a surgical stapling instrument includes an anvil assembly including an anvil head and an anvil center rod extending proximally from the anvil head, a reload assembly including a pusher and an annular staple cartridge including a plurality of staples. The pusher is configured to eject staples from the annular staple cartridge. The surgical stapling instrument further includes a processor and a memory. The memory includes instructions stored thereon, which, when executed, cause the surgical stapling instrument to advance the pusher towards the anvil assembly from a first position to a second position, determine if the pusher stopped advancing towards the anvil assembly prior to the second position, measure a force of staple compression of a staple being ejected from the annular staple cartridge by the pusher, in response to the pusher having stopped advancing towards the anvil assembly, and determine if the force of staple compression is outside of a predetermined range.
In an aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to enter a tissue cutting mode of the surgical stapling instrument in response to the force of staple compression based on a predetermined acceptable range of staple compression.
In another aspect, the force of staple compression is measured by a strain gauge.
In yet another aspect, the force of staple compression is measured based on a current of a motor configured to advance the pusher.
In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to prevent staple firing in response to the force of staple compression being greater than the predetermined range.
In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to display a warning on a display if the force of staple compression is greater than the predetermined range
In still yet another aspect, the displayed warning may include a warning to inspect a surgical site and/or to unclamp tissue.
In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to retract the pusher.
In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to generate an audio warning in response to the force of staple compression being greater than the predetermined range.
In accordance with other aspects of the disclosure, a non-transitory computer-readable medium stores instructions which, when executed by a processor, cause the processor to perform a method for controlling a surgical stapling instrument, including: advancing a pusher towards an anvil assembly of the surgical stapling instrument from a first position to a second position, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument; determining whether the pusher stopped advancing towards the anvil assembly prior to the second position; measuring a force of staple compression of a staple being ejected from the staple cartridge by the pusher; and determining if the force of staple compression is outside of a predetermined range.
Systems and methods for controlling surgical stapling instruments for clamping and stapling are disclosed herein with reference to the drawings, wherein:
The disclosed surgical device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the aspects of the disclosure are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
This disclosure is directed to a surgical stapling instrument that controls stapling of tissue based in part on determination of a closure state of the staple, in particular, distinguishing between staple formations that are sufficient and prevent leaks and staple formations that are insufficient.
The handle assembly 20 is illustrated as a powered assembly and includes a grip 22, an actuation button 24 for controlling firing of staples (not shown) from the annular staple cartridge 48 of the reload assembly 16, and approximation buttons 26a, 26b for controlling axial displacement of the anvil assembly 50 towards and away from the reload assembly 16 between the open and clamped positions. For a detailed description of the structure and function of exemplary powered handle assemblies, reference may be made to U.S. Patent Application Publication Nos. 2020/0015820 and 2019/0343517. Although the disclosure illustrates a powered assembly, it is envisioned that advantages of the disclosure, as described in detail below, are also applicable to robotically actuated surgical instruments.
The handle assembly 20 may include an electrical assembly including a strain gauge 51 (
Each of the staple receiving pockets 48a (
As described above, the first, second, and third shafts are 106, 108, and 110 of the adapter assembly 100 are coupled to the powered handle assembly 20 by motor shafts 152a, 154a, 156a that are coupled to motors 152, 154, 156 (
Drive assembly 119 (
When the surgical stapling instrument 10 is fired, the staple legs 504 (
The handle assembly 20 may include a sensor such as the strain gauge 51 (
In aspects of the disclosure, the memory 330 can be random access memory, read-only memory, magnetic disk memory, solid-state memory, optical disc memory, and/or another type of memory. In some aspects of the disclosure, the memory 330 can be separate from the controller 300 and can communicate with the processor 320 through communication buses of a circuit board and/or through communication cables such as serial ATA cables or other types of cables. The memory 330 includes computer-readable instructions that are executable by the processor 320 to operate the controller 300. The memory 330 may include volatile (e.g., RAM) and non-volatile storage configured to store data, including software instructions for operating the handle assembly 20. In other aspects of the disclosure, the controller 300 may include a network interface 340 to communicate with other computers or to a server. A storage device 310 may be used for storing data.
In aspects of the disclosure, the strain gauge 51 (
With reference to
The battery 144 and the motor 152 are coupled to the motor controller circuit board 142a having a motor controller 143 which controls the operation of the motor 152 including the flow of electrical energy from the battery 144 to the motor 152. The main controller 300 (
The motor controller 143 is coupled to the main controller 300, which includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 300 receives measured sensor signals from the motor controller 143 regarding operational status of the motor 152 and the battery 144 and, in turn, outputs control signals to the motor controller 143 to control the operation of the motor 152 based on the sensor readings and specific algorithm instructions, which are discussed in more detail below. The main controller 300 is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc. coupled to the main controller 300).
The main controller 300 is also coupled to the strain gauge 51 of the circular adapter assembly 200 using a wired or a wireless connection and is configured to receive strain measurements from the strain gauge 51 which are used during operation of the handle assembly 20.
The reload assembly 16 includes a storage device 405 (e.g., chip 464c). The adapter assembly 200 also includes a storage device 407. The storage devices 405 and 407 include non-volatile storage medium (e.g., EEPROM) that is configured to store any data pertaining to the reload assembly 16 and the circular adapter assembly 200, 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 aspects, the data may be encrypted and is only decryptable by devices (e.g., main controller 300) have appropriate keys. The data may also be used by the main controller 300 to authenticate the circular adapter assembly 200 and/or the reload assembly 16. The storage devices 405 and 407 may be configured in read only or read/write modes, allowing the main controller 300 to read as well as write data onto the storage device 405 and 407.
Once the pusher 61 is moved in relation to the anvil assembly 50, if the controller 300 determines that the pusher 61 has stopped advancing towards the anvil assembly 50 before it has reached a predetermined second position (Step 404), a force of staple compression on the staple “S” clamped between the staple cartridge 48 and the anvil assembly 50 is measured (Step 406). As discussed above, the stapling force of the staple “S” clamped between the anvil assembly 50 and the pusher 61 of the within the reload assembly 16 (
The controller 300 determines if the staple compression force is outside of a predetermined acceptable range (Step 408). For example, the staple compression force may spike beyond the range of forces measured during staple formation.
If the compression force on the staple is within the predetermined acceptable range of compression, the surgical stapling instrument 10 enters the tissue cutting mode to allow a surgeon to cut the tissue and complete the procedure (Step 410). In aspects, the predetermined acceptable range of staple compression may vary depending on the type of tissue that is being treated and may be set automatically by the instrument 10 or by the user. In various aspects, the predetermined acceptable range of staple compression may be based on using different reloads, different staple heights, and/or different types of surgical staplers.
If the compression force is greater than the predetermined acceptable range of compression, the pusher 61 is retracted, and the surgical stapling instrument 10 exits firing mode (Step 412). In some aspects of the disclosure, the controller may provide a warning on a display 146 (
Although this disclosure is directed to a powered surgical stapling instrument, it is envisioned the principles of this disclosure are applicable to manually powered stapling instruments. For example, the clamping pressure on tissue clamped between an anvil assembly and a staple cartridge of the stapling instrument can be measured as the stapling instrument is moved through a predetermined acceptable tissue gap range. In such a device, an indicator such as a light can be provided on the instrument. When the clamping pressure of the tissue enters the predetermined acceptable range of compression with the instrument within the predetermined acceptable gap range, the indicator can be activated to notify the surgeon that the instrument is ready to be fired.
It is envisioned that the aspects of this disclosure, although illustrated in association with a circular stapling instrument, are equally applicable to other types of stapling instruments, including linear stapling devices, vessel sealing devices, and other devices for joining tissue sections together.
Persons skilled in the art will appreciate that one or more operations of the method 500 may be performed in a different order, repeated, and/or omitted without departing from the scope of the disclosure. In various aspects, the illustrated method 400 can operate in the controller 300 (
Persons skilled in the art will understand that the instruments and methods specifically described herein and illustrated in the accompanying drawings are non-limiting. It is envisioned that the elements and features may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure.
The present application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/056,746, filed on Jul. 27, 2020, the entire content of which being hereby incorporated by reference.
Number | Date | Country | |
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63056746 | Jul 2020 | US |