Real-time stapling tissue perfusion assessment

Abstract

A surgical stapler includes a stapler cartridge having a plurality of staples. The surgical stapler also includes a spectroscopic assembly disposed within the stapler cartridge and having a plurality of light sources and a plurality of photodetectors interspersed between the plurality of light sources. The surgical stapler further includes a controller coupled to the spectroscopic assembly. The controller is configured to operate the plurality of light sources to irradiate light onto tissue in contact with the stapler cartridge. The controller is further configured to receive signals from the plurality of photodetectors based on the reflected light detected by the plurality of photodetectors and to determine the degree of blood perfusion within the tissue based on the signals.

Description

Technical Field

[0001] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to an electromechanical surgical system for performing stapling surgical procedures.

Background Art

[0002] Surgical fastener devices for applying fasteners or staples to tissue are well known. These fastener devices include surgical staplers, which can be manual or electric. There are multiple types of powered surgical staplers, such as linear staplers or circular staplers, which are specially designed for performing certain types of surgical procedures, including endoscopic procedures that provide real-time images of the surgical site through a laparoscope camera or an endoscope camera.

[0003] Linear staplers are used in various surgical procedures, such as resection or cutting of organs and other tissues. Circular staplers are used for reattaching a previously transected rectal portion or similar procedures. Linear staplers and circular staplers can be operated manually or power-operated and can include a pistol-type or linear grip-type structure having an elongated shaft extending therefrom and a staple cartridge supported at the distal end of the elongated shaft.

[0004] Regarding circular staplers, a physician can insert the anvil assembly of a circular stapling instrument through an incision towards the transected rectal portion. The physician can also insert the remaining portion of the circular stapling instrument (including the cartridge assembly) into the patient's rectum and skillfully move the instrument from the patient's colon towards the transected rectal portion. The anvil assembly and the cartridge assembly are brought closer to each other, staples are ejected from the cartridge assembly towards the anvil assembly, staples are formed in the tissue to affect end-to-end anastomosis, and a circular knife is advanced to core out a part of the clamped tissue portion. After the end-to-end anastomosis is affected, the circular stapling instrument is removed from the surgical site.

[0005] After staple placement, maintaining appropriate blood flow in the staple line region, whether linear or circular, aids tissue recovery. Currently, an instrument capable of evaluating angiogenesis between staples is needed as an indicator of appropriate blood flow in the staple line region. Summary of the Invention Means for Solving the Problems

[0006] The present disclosure provides a powered stapler (e.g., circular or linear) configured to form a staple line, such as a linear staple line or anastomosis, by connecting two portions of a structure (e.g., intestine, colon, etc.). The powered stapler includes a handle assembly having a power source and one or more motors coupled to the power source. The stapler also includes an adapter assembly having a plurality of transmission assemblies, such as drive shafts, for transmitting actuation from the powered handle. The powered handle assembly and the adapter assembly may be reusable.

[0007] The powered surgical stapler operates in four stages: clamp, staple placement, cut, and clamp release. In the case of a linear stapler, clamping, staple placement, and cutting occur while the drive shaft is being advanced, and clamp release occurs while the drive shaft is being reversed.

[0008] In the case of a circular stapler, clamping is achieved by moving the anvil in the proximal direction to compress tissue between the anvil and a reload assembly including a plurality of staples. The anvil and the reload assembly may be disposable. During staple placement, the staples are ejected from the reload assembly into the clamped tissue and deformed against the anvil. Cutting includes moving a circular knife through the compressed and stapled tissue until the knife contacts the anvil. During clamp release, the anvil assembly is moved distally from the cut tissue and the reload assembly.

[0009] The powered stapler includes a real-time near-infrared spectroscopy (NIRS) system that provides blood flow measurements within the reload assembly to enable the estimation of tissue perfusion during stapling procedures. The NIRS system, which may include diffuse correlation spectroscopy, is an optical method for evaluating blood flow within tissue using near-infrared light (NIR) (e.g., NIR light having wavelengths from about 700 nm to about 900 nm). Depending on the source-detector distance, the light passes through different depths of the tissue, and analysis of the collected backscattered light indicates the blood flow level within the tissue. One or more light sources and detectors can be placed within the circular stapler to enable tissue perfusion or oximetry evaluation around the staple line during or after the procedure.

[0010] The NIRS system according to the present disclosure can be incorporated into any surgical stapler, i.e., circular, linear, or other staplers, and the light sources and detectors are scattered along the staple line. In particular, the light source, which may be a laser, and the detector can be incorporated within the design of linear and / or circular staplers to create a reflectance-type laser doppler flowmeter for measuring the richness of the staple line.

[0011] In an embodiment, the NIRS system can include a ring-shaped or linear flexible circuit disposed adjacent to, e.g., behind, the staple guide of the reload assembly. The flexible circuit can be disposed adjacent to any staple row, e.g., the inner row, middle row, etc., along an outer row of the staple line. LEDs, combinations of IR LEDs, IR and red LEDs, or other light sources irradiate light through the openings of the staple guide, and the light reflected through the tissue travels towards photodiodes (i.e., light detectors) scattered between the light sources. The light sources and photodiodes are individually addressable, and the richness at the location of a particular photodiode can be determined.

[0012] The flexible circuit may be connected to a wire harness, which connects the NIRS system to the adapter and handle assembly. Analog / digital (A / D) conversion is performed at the distal end of the adapter or within the flexible circuit itself because analog signals transmitted along the wire harness are susceptible to electromagnetic interference. In an embodiment, the transmission can be wireless. In a further embodiment, the signal from the photodetector can be received by a processing unit disposed within a powered handle and connected to the detector by an optical fiber through an adapter. In an embodiment, the light source and photodiode may be coupled to an optical connector such that light is transmitted through an optical fiber disposed through each component of the powered surgical stapler (e.g., end effector, adapter, handle).

[0013] According to one embodiment of the present disclosure, a surgical stapler is disclosed. The surgical stapler includes a stapler cartridge having a plurality of staples. The surgical stapler also includes a spectroscopy assembly disposed within the stapler cartridge having a plurality of light sources and a plurality of photodetectors interspersed between the plurality of light sources. The surgical stapler further includes a controller coupled to the spectroscopy assembly. The controller is configured to activate the plurality of light sources to irradiate light onto tissue in contact with the stapler cartridge. The controller is further configured to receive signals from the plurality of photodetectors based on the reflected light detected by the plurality of photodetectors and determine the degree of blood perfusion within the tissue based on the signals.

[0014] The embodiments of the above-described embodiments may include one or more of the following features. According to one aspect of the above-described embodiments, the stapler cartridge may have a linear or annular shape, include a plurality of staples, and include a tissue contact surface having a plurality of staple pockets that define a plurality of openings. The spectroscopic assembly may include a flexible circuit having a linear or annular shape on which a plurality of light sources and a plurality of photodetectors are disposed. Each light source of the plurality of light sources and each photodetector of the plurality of photodetectors are aligned with one of the plurality of openings. The surgical stapler may include a tubular housing configured to removably couple to the stapler cartridge. The tubular housing may include an electrical connector configured to electrically couple to the flexible circuit and a wire harness that extends through the tubular housing and connects the electrical connector to a controller. The tubular housing may include an optical connector configured to couple to the plurality of light sources and the plurality of photodetectors. The optical connector is coupled to one or more optical fibers disposed within the tubular housing and is coupled to at least one analog / digital converter configured to convert signals from the plurality of photodetectors from analog to digital. The electrical connector may include at least one analog / digital converter configured to convert signals from the plurality of photodetectors from analog to digital. The surgical stapler may also include a display configured to display a graphical user interface. The controller may be further configured to output the degree of blood perfusion on the graphical user interface.

[0015] According to another embodiment of the present disclosure, a surgical stapler is disclosed. The surgical stapler includes an annular reload having a stapler cartridge containing a plurality of staples. The annular reload also includes an anvil assembly movable relative to the annular reload and configured to compress tissue therebetween, and a knife assembly disposed within the annular reload and configured to cut tissue. The annular reload further includes a spectroscopic assembly disposed within the stapler cartridge having a plurality of light sources and a plurality of photodetectors interspersed between the plurality of light sources. The surgical stapler also includes a handle assembly having one or more motors configured to operate the anvil assembly, the stapler cartridge, and the knife assembly. The handle assembly also includes a controller coupled to the spectroscopic assembly. The controller is configured to control the motors. The controller is further configured to operate the plurality of light sources to irradiate light onto tissue in contact with the stapler cartridge. The controller is also configured to receive signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors and to determine the degree of blood perfusion within the tissue based on the signals.

[0016] The embodiments of the above-described embodiments may include one or more of the following features. According to one aspect of the above-described embodiments, the controller may be further configured to control at least one motor based on the degree of blood perfusion. The stapler cartridge may include a tissue contact surface having an annular shape, including a plurality of staples and having a plurality of staple pockets defining a plurality of openings. The spectroscopic assembly may include a flexible circuit having an annular shape on which a plurality of light sources and a plurality of photodetectors are disposed. Each light source of the plurality of light sources and each photodetector of the plurality of photodetectors are aligned with one of the plurality of openings. The surgical stapler may include a tubular housing coupled to the housing assembly. The tubular housing may be configured to removably couple to the stapler cartridge. The tubular housing may also include an electrical connector configured to electrically couple to the flexible circuit to a wire harness that extends through the tubular housing and connects the electrical connector to the controller. The electrical connector may include at least one analog / digital converter configured to convert a signal from the plurality of photodetectors from analog to digital. The surgical stapler may also include a display configured to display a graphical user interface. The controller may be further configured to output the degree of blood perfusion on the graphical user interface. The controller may also be configured to output the degree of blood perfusion on the graphical user interface for each segment of the tissue corresponding to each photodetector of the plurality of photodetectors.

[0017] According to a further embodiment of the present disclosure, a surgical stapler is disclosed. The surgical stapler includes a first jaw having a stapler cartridge with a plurality of staples, and a second jaw movable relative to the first jaw and configured to compress tissue therebetween. The surgical stapler also includes a spectroscopic assembly disposed within at least one of the first jaw or the second jaw, the spectroscopic assembly including a plurality of light sources and a plurality of photodetectors interspersed among the plurality of light sources. The surgical stapler further includes a handle assembly having at least one motor configured to move at least one of the first jaw or the second jaw and to eject the plurality of staples, and a controller coupled to the spectroscopic assembly. The controller is configured to control the at least one motor and to activate the plurality of light sources to irradiate light onto tissue in contact with the stapler cartridge. The controller is further configured to receive signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors and to determine the degree of blood perfusion within the tissue based on the signals.

[0018] Embodiments of the present disclosure are described herein with reference to the accompanying drawings.

Brief Description of the Drawings

[0019]

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[0020] Embodiments of the surgical devices, adapter assemblies, and / or handle assemblies for surgical devices disclosed herein are described in detail with reference to the drawings, in which like reference numerals refer to the same or corresponding elements in each of several figures. As used herein, the term "distal" refers to the portion of a surgical instrument or component thereof that is farther from the user, while the term "proximal" refers to the portion of a surgical instrument or component thereof that is closer to the user.

[0021] The present disclosure provides a powered stapler (e.g., circular or linear) having a handle assembly, an adapter assembly coupled to the handle assembly, and an end effector coupled to the adapter assembly. The stapler enables complete, independent control of three functions, namely, clamping, suturing, and cutting. This allows adaptation of specific portions of the stapler when the tissue presents non-ideal situations.

[0022] FIG. 1 shows a surgical device, such as a powered circular stapler 10 for forming, for example, an end-to-end anastomosis (“EEA”), including a handle assembly 100 configured for selective connection with an adapter assembly 200. In an embodiment, the powered stapler 10 can be a linear stapler. The adapter assembly 200 is configured for selective connection with an end effector 300, including a reload 400 and an anvil assembly 500. The end effector 300 is configured to effect a surgical effect on a patient's tissue by clamping, suturing, and cutting tissue held within the end effector 300, i.e., forming an anastomosis by connecting two portions of a structure (e.g., intestine, colon, etc.).

[0023] The handle assembly 100 includes a power handle 101 and an outer shell housing 11 configured to selectively receive and enclose the power handle 101. The shell housing 11 includes a distal half 11a and a proximal half 11b pivotally connected to the distal half 11a. When joined, the distal and proximal halves 11a, 11b define a shell cavity within which the power handle 101 is disposed.

[0024] The powered circular stapler 10 is described herein as a modular device including a plurality of interconnected components such as the handle assembly 100, the removable shell housing 11, and the adapter assembly 200, among others, but the powered circular stapler 10 may be formed as an integral device, for example, during manufacture of the powered circular stapler, in which one or more of the components are fixedly attached to each other.

[0025] The tip and base halves 11a, 11b of the shell housing 11 are divided along a plane transverse to the longitudinal axis "X" of the adapter assembly 200. The tip half 11a of the shell housing 11 defines a connection portion 20 configured to receive the corresponding drive coupling assembly 210 (FIG. 3) of the adapter assembly 200. The tip half 11a of the shell housing 11 supports a toggle control button 30. The toggle control button 30 can be actuated in four directions (e.g., left, right, up, and down).

[0026] Referring to FIGS. 1 and 2, the power handle 101 includes a circuit board 142, a rechargeable battery 144 configured to supply power to any of the electrical components of the handle assembly 100, and a plurality of motors coupled to the battery 144, namely a first motor 152a, a second motor 152b, and a third motor 152c. The power handle 101 also includes a display 146. In an embodiment, the motors 152a, 152b, 152c can be coupled to any suitable power source configured to supply electrical energy to the motors 152a, 152b, 152c, such as an AC / DC transformer. Each of the motors 152a, 152b, 152c is coupled to a motor controller 143 that controls the operation of the corresponding motor 152a, 152b, 152c, including the flow of electrical energy from the battery 144 to the motors 152a, 152b, 152c. A main controller 147 is provided for controlling the power handle 101. The main controller 147 is configured to execute software instructions that implement algorithms disclosed herein, such as clamp, staple, and cut algorithms, for controlling the operation of the power handle 101. The main controller 147 also processes optical signals from the assembled spectrometer, as described in more detail below.

[0027] The motor controller 143 includes a plurality of sensors 408a…408n configured to measure the operating states of motors 152a, 152b, 152c and battery 144. Sensors 408a~n include strain gauges 408b and may also include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. Sensors 408a~408n may measure the voltage, current, and other electrical characteristics of the electrical energy supplied by battery 144. Sensors 408a~408n may also measure the angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operating characteristics of motors 152a, 152b, 152c. Sensor 408a also includes an encoder configured to count the rotation or other indicators of motors 152a, 152b, 152c, which is then used by main controller 147 to calculate the linear movement of the components movable by motors 152a, 152b, 152c. The angular velocity may be determined by measuring the rotation of motors 152a, 152b, 152c or a drive shaft (not shown) coupled to motors 152a, 152b, 152c and rotatable by motors 152a, 152b, 152c. The position of the drive shaft movable in various axial directions may also be determined by using various linear sensors disposed on or proximate to the shaft, or may be estimated from the RPM measurements. In an embodiment, the torque may be calculated based on the regulated current draw of motors 152a, 152b, 152c at a constant RPM. In a further embodiment, motor controller 143 and / or main controller 147 may measure time, for example, to determine the rate of change of the measured values, and process the values described above, including integration and / or differentiation, over time. Main controller 147 is also configured to determine the travel distances of the various components of adapter assembly 200 and / or end effector 300 by counting the rotations of motors 152a, 152b, 152c.

[0028] The motor controller 143 is coupled to the main controller 147, and the main controller 147 includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 147 receives measured sensor signals regarding the operating states of the motors 152a, 152b, 152c from the motor controller 143, and the battery 144, in turn, outputs control signals to the motor controller 143 to control the operation of the motors 152a, 152b, 152c based on the sensor readings and specific algorithm instructions. The main controller 147 is also configured to receive a plurality of user inputs, for example, from a user interface (such as switches, buttons, touchscreens, etc.) coupled to the main controller 147.

[0029] The main controller 147 is also coupled to the memory 141. 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 gauge 408b of the adapter assembly 200 using a wired or wireless connection and is configured to receive strain measurements from the strain gauge 408b used during the operation of the power handle 101.

[0030] The power handle 101 includes a plurality of motors 152a, 152b, 152c, each including a respective motor shaft (not explicitly shown) that extends therefrom and is configured to drive a respective transmission assembly. The rotation of the motor shaft by each motor functions to drive the shaft and / or gear components of the adapter assembly 200 to perform various operations of the handle assembly 100. In particular, the motors 152a, 152b, 152c of the power handle 101 are configured to drive the shaft and / or gear components of the adapter assembly 200 to selectively extend / retract the trocar member 274 of the trocar assembly 270 of the adapter assembly 200 (FIG. 4), and this trocar member 274 may be fixed or removable. The extension / retraction of the trocar member 274 opens and closes the end effector 300, fires the annular array of staples 423 of the reload 400, and moves the annular knife 444 of the reload 400 (when the anvil assembly 500 is connected to the trocar member 274 of the trocar assembly 270).

[0031] Referring now to FIGS. 3 and 4, the adapter assembly 200 includes an outer knob housing 202 and a tubular housing 206 that extends from the tip of the knob housing 202. The knob housing 202 and the tubular housing 206 are configured and dimensioned to house the components of the adapter assembly 200. The knob housing 202 includes an electrical connection 312 and a memory device 310 coupled thereto. The memory device 310 is configured to store various operating parameters related to the adapter assembly 200. The adapter assembly 200 is configured to convert the rotation of a coupling shaft (not explicitly shown) of the handle assembly 100 into an axial translational motion useful for operating the trocar assembly 270, the anvil assembly 500, and / or the staple driver 430 or knife assembly 440 of the reload 400 of the adapter assembly 200.

[0032] The adapter assembly 200 further includes a trocar assembly 270 removably supported at the tip of the tubular housing 206. The trocar assembly 270 includes a trocar member 274 and a driving screw 276 operably received within the trocar member 274 for axially moving the trocar member 274 relative to the tubular housing 206. The tip 274b of the trocar member 274 is configured to selectively engage the anvil assembly 500 such that axial movement of the trocar member 274 results in an associated axial movement of the anvil assembly 500 via rotation of the driving screw 276.

[0033] Referring to FIG. 4, the tightening transmission assembly 240 includes a first rotatable proximal drive shaft 212 coupled to the first motor 152a, a second rotatable proximal drive shaft 281, a rotatable distal drive shaft 282, and a coupling member 286, each of which is supported within the tubular housing 206 of the adapter assembly 200. The tightening transmission assembly 240 functions to extend / retract the trocar member 274 of the trocar assembly 270 of the adapter assembly 200 and to open / close the anvil assembly 500 when the anvil assembly 500 is connected to the trocar member 274.

[0034] Referring to FIG. 5, the adapter assembly 200 includes a suturing transmission assembly 250 for interconnecting the second motor 152b and the second axially translatable driver member of the reload 400. The suturing transmission assembly 250 converts and transmits the rotation of the second motor 152b into an axial translation of the outer flexible band assembly 255 of the adapter assembly 200 and thus into the stapler driver 430 of the reload 400 to fire staples 423 from the reload 400 and against the anvil assembly 500.

[0035] The suture transmission assembly 250 of the adapter assembly 200 includes an outer flexible band assembly 255 fixed to the staple driver coupler 254. The second rotatable proximal drive shaft 220 is coupled to the second motor 152b and is configured to operate the staple driver coupler 254, which converts rotational movement into longitudinal movement. The outer flexible band assembly 255 includes first and second flexible bands 255a, 255b that are laterally spaced apart and are connected at their proximal ends to the support ring 255c and at their distal ends to the proximal end of the tip pusher 255d. Each of the first and second flexible bands 255a, 255b is attached to the support ring 255c and the tip pusher 255d. The outer flexible band assembly 255 further includes first and second connection extensions 255e, 255f that extend proximally from the support ring 255c. The first and second connection extensions 255e, 255f are configured to operably connect the outer flexible band assembly 255 to the staple driver coupler 254 of the suture transmission assembly 250.

[0036] Referring to FIG. 6, the adapter assembly 200 also includes a cutting transmission assembly 260 having a third rotatable proximal drive shaft 222 for interconnecting the third motor 152c and the annular knife 444 of the reload 400. The cutting transmission assembly 260 converts and transmits one rotation of the third motor 152c into axial movement of the outer flexible band assembly 265 of the adapter assembly 200 and thus the knife carrier 442 of the reload 400, advancing the annular knife 444 from the reload 400 toward the anvil assembly 500.

[0037] The inner flexible band assembly 265 includes first and second flexible bands 265a, 265b that are laterally spaced apart and are connected at their proximal ends to the support ring 265c and at their distal ends to the proximal end of the support base 265d. Each of the first and second flexible bands 265a, 265b is attached to the support ring 265c and the support base 265d.

[0038] The inner flexible band assembly 265 further includes first and second connection extensions 265e, 265f that extend proximally from the support ring 265c. The first and second connection extensions 265e, 265f are configured to operably connect the inner flexible band assembly 265 to the knife driver 264 of the cutting transmission assembly 260. The support base 265d extends distally from the flexible bands 265a, 265b and is configured to connect to the knife assembly 440 of the reload 400.

[0039] Referring to FIG. 7, the staple driver 430 of the reload 400 includes an annular staple cartridge 420 having a driver adapter 432 and a driver 434. The proximal end 432a of the driver adapter 432 is configured for selective contact and abutment with the tip pusher 255d of the outer flexible band assembly 255 of the suture transmission assembly 250 of the adapter assembly 200. During operation, as described above, during the forward movement of the outer flexible band assembly 255 to the distal end side, the tip pusher 255d of the outer flexible band assembly 255 contacts the proximal end 432a of the driver adapter 432, advancing the driver adapter 432 and the driver 434 from the first or proximal position to the second or distal position. The driver 434 is a plurality of driver members 436, including a plurality of driver members 436 aligned with the staple pockets 421 of the staple cartridge 420 for contact with the staples 423. Correspondingly, the advancement of the driver 434 relative to the staple cartridge 420 causes the staples 423 to be removed from the staple cartridge 420.

[0040] The knife assembly 440 of the reload 400 includes a knife carrier 442 and an annular knife 444 fixed around the distal end 442b of the knife carrier 442. The proximal end 442a of the knife carrier 442 is configured to engage the support base 265d of the inner flexible band assembly. During operation, during the distal advancement of the inner flexible band assembly 265, the support base 265d of the inner flexible band assembly 265 connects with the proximal end 442a of the knife carrier 442 to advance the knife carrier 442 and the annular knife 444 from a first position or a proximal position to a second position or an advanced position, causing the cutting of tissue disposed between the staple cartridge 420 and the anvil assembly 500.

[0041] During the actuation of the trocar member 274, during the closure of the end effector 300 (e.g., the storage of the anvil assembly 500 relative to the reload 400), during the ejection of the staples 423 from the reload 400, and during the advancement of the knife assembly 440, the forces can be measured by the strain gauge 408b to monitor and control various processes such as the firing of the staples 423 from the reload 400; to monitor the forces during the firing and formation of the staples 423 as the staples 423 are ejected from the reload 400; to optimize the formation (e.g., staple crimp height) of the staples 423 as the staples 423 are ejected from the reload 400 for different conditions of the tissue; and to monitor and control the firing of the annular knife of the reload 400.

[0042] Referring to FIG. 8, the strain gauge 408b of the adapter assembly 200 is disposed within the strain gauge housing 320. The strain gauge 408b measures and monitors the storage of the trocar member 274 and the extraction and formation of staples 423 from the reload 400. During the closing of the end effector 300, when the anvil assembly 500 contacts tissue, an obstacle, the tissue contact surface of the reload 400, staple extraction, etc., a reaction force in the generally distal direction is applied to the anvil assembly 500. This reaction force directed towards the distal side is transmitted from the anvil assembly 500 to the strain gauge 408b. The strain gauge 408b then transmits a signal to the main controller 147 of the power handle 101 of the handle assembly 100. A graphic (FIG. 8) is then displayed on the display 146 of the handle assembly 100 to provide the user with real-time information related to the firing status of the handle assembly 100.

[0043] The trocar assembly 270 is fixed within the tubular housing 206 of the adapter assembly 200 so as not to move axially and not to rotate. Referring to FIG. 8, the adapter assembly 200 includes a support block 292 disposed within the tubular housing 206 so as not to move. The strain gauge housing 320 is disposed between the support block 292 and the connector sleeve 290. The reload 400 is removably coupled to the connector sleeve 290.

[0044] During operation, the strain gauge 408b of the adapter assembly 200 measures and monitors the storage of the trocar member 274 passing through the strain gauge 408b. Since the first and second flexible bands 255a, 255b also pass through the strain gauge 408b, the strain gauge 408b of the adapter assembly 200 also measures and monitors the extraction of staples 423 from the reload 400. During clamping, suturing, and cutting, reaction forces are applied to the anvil assembly 500 and the reload 400, which are transmitted to the support block 292, which then transmits the reaction forces to the strain sensor of the strain gauge 408b.

[0045] When the object deforms, the strain sensor of the strain gauge 408b also deforms the metal foil of the strain sensor, changing its electrical resistance, and this change in resistance is then used to calculate the load received by the trocar assembly 270, and it can be any device configured to measure the strain (a dimensionless quantity) of the object (such as the support block 292) to which it is attached. The strain gauge 408b provides closed-loop feedback to the firing / tightening load presented by the first, second, and third force / rotation transfer / conversion assemblies.

[0046] Next, the strain sensor of the strain gauge 408b transmits a signal to the main controller 147. Next, a graphic is displayed on the display 146 of the handle assembly 100, and real-time information related to the firing state of the handle assembly 100 is provided to the user. The strain gauge 408b is also electrically connected to the electrical connector 312 (FIG. 3) via a wire harness 314 having a proximal portion 314a. The wire harness 314 can be any ribbon cable or any other suitable cable or wire assembly. The distal portion 314b of the wire harness 314 is coupled to a distal connector 322 supported by the connector sleeve 290. The distal connector 322 is configured to selectively mechanically, electrically, and / or optically connect to the reload 400 when the reload 400 is connected to the adapter assembly 200. In particular, the connector 322 can include a plug having a pair of contacts 322a and 322b. The connector 322 is also configured to couple to the memory device 402.

[0047] For further details regarding the construction and operation of the circular stapler and its components, reference may be made to the pamphlet of International Publication No. PCT / US2019 / 040440 filed on July 3, 2019, the entire content of which is incorporated herein by reference.

[0048] Reload 400 includes a memory device 402, and the circular adapter assembly 200 also includes a memory device 310 (FIG. 4). The memory devices 402 and 310 each include non-volatile memory media (e.g., EEPROM) configured to store any data related to the reload 400 and the circular adapter assembly 200, including but not limited to the number of uses, identification information, model number, serial number, staple size, stroke length, maximum operating force, minimum operating force, factory calibration data, etc. In an embodiment, the data can be encrypted and can be decrypted only by a device (e.g., the main controller 147) having an appropriate key. The data can also be used by the main controller 147 to authenticate the circular adapter assembly 200 and / or the reload 400. The memory devices 402 and 310 can be configured in a read-only mode or a read / write mode, enabling the main controller 147 not only to read the data but also to write data to the memory devices 402 and 310.

[0049] Referring to FIGS. 9 and 10, a spectroscopic assembly or NIRS system 600 is shown. The NIRS system 600 includes a plurality of light sources 602, which may be laser diodes, configured to output NIR light that can be in the range of about 700 nm to about 900 nm. In an embodiment, the light sources 602 can also output light in the red and NIR ranges that can be in the range of about 650 nm to about 850 nm.

[0050] The NIRS system 600 operates by transmitting light from the light sources 602 through the tissue intervening between the reload 400 and the anvil assembly 500 and detecting the light reflected therefrom with a plurality of photodetectors 604. The photodetectors 604 can be photodiodes or any other suitable photosensitive elements configured to operate at the spectrum of the light sources 602.

[0051] The light source 602 and the photodetector 604 are scattered along the outer periphery of the reload 400. In particular, the light source 602 and the photodetector 604 are disposed on a ring-shaped flexible circuit 606 that provides electrical connections, such as traces, to each of the light source 602 and the photodetector 604. The flexible circuit 606 can be disposed at any position of the reload 400, for example, from the periphery to the inside. The flexible circuit 606 is disposed within the staple cartridge 420, and the staple cartridge 420 includes a plurality of openings 426 defined in the staple fastening surface 428. The openings 426 can be aligned with each of the light source 602 and the photodetector 604 to allow light transmission. The openings 426 can have any suitable depth, for example, from about 0.1 mm to about 2 mm in depth, to prevent external light from hitting the photodetector 604.

[0052] The flexible circuit 606 also includes leads 608 having a pair of connectors 608a and 608b configured to couple to the contacts 322a and 322b of the connector 322 (FIG. 8). The connector 322 can be electrical or optical and can include an A / D converter for converting an analog signal from the photodetector 604 for transmission along the wire harness 314 to the main controller 147. In an embodiment, the A / D converter can be disposed within the handle assembly 100.

[0053] The main controller 147 is configured to process signals from the photodetector 604 to determine the level of perfusion within the stapled tissue. In an embodiment, the photodetector 604 may be individually addressable such that perfusion can be evaluated by the main controller 147 at each location of the photodetector 604. In an embodiment, the main controller 147 may display on the display 146 a graphical user interface (GUI) indicating the degree of perfusion and / or whether the perfusion is at a desired level corresponding to the success of the stapling operation. The GUI may be displayed on any other display present in the operating room. The GUI can use color-coded indicators, e.g., red, yellow, green, to indicate the perfusion assessment. In embodiments having individually addressable photodetectors 604, each perfusion may be separately displayed within a segmented ring in an area corresponding to each of the addressable photodetectors 604, for example.

[0054] Prior to operation of the powered circular stapler 10, the power handle 101 is enclosed within the shell housing 11 and the adapter assembly 200 is coupled to the handle assembly 100. After attachment of the circular adapter assembly 200, the handle assembly 100 first confirms that the circular adapter assembly 200 is coupled thereto by establishing communication with the memory device 310 of the circular adapter assembly 200 and authenticates the circular adapter assembly 200. The data stored in the memory device 310 (e.g., number of uses) is encrypted and authenticated by the power handle 101 before determining whether the number of uses stored in the memory device 310 exceeds a threshold (e.g., whether the adapter assembly 200 has been used previously). Next, the power handle 101 performs a verification check (e.g., end-of-life check, absence of the trocar member 274, etc.), and after the handle assembly 100 confirms that the trocar member 274 is attached, calibrates the circular adapter assembly 200.

[0055] The user begins a surgical procedure by positioning an adapter assembly 200, which includes a trocar member 274 and an anvil assembly 500, within the recto-colon or upper gastrointestinal region. The user presses a toggle control button 30 to extend the trocar member 274 until it pierces tissue. After the trocar member 274 is extended, the anvil assembly 500, which has been pre-positioned by the surgeon, is attached to the trocar member 274, and the user begins a clamping process on the tissue inserted between the reload 400 and the anvil assembly 500 by pressing the bottom of the toggle control button 30.

[0056] The powered circular stapler 10 may also initiate an optical verification or a baseline test before starting a stapling procedure. The clamping process may include controlled tissue compression until a desired threshold is reached. When the tissue is compressed, the user may initiate the stapling process by pressing the toggle control button 30. In an embodiment, the baseline test may be performed after the tissue has been compressed.

[0057] In an embodiment, when tissue compression is verified by the main controller 147, the stapling process may be automatically initiated. When stapling is complete, cutting is initiated automatically or by pressing the toggle control button 30, at which point the main controller 147 begins a perfusion check that includes energizing a light source 602 to illuminate the stapled tissue. The reflected or backscattered light is received by a photodetector 604, which provides the detected signal to the main controller 147, and the main controller 147 compares the signal to a perfusion threshold. The main controller 147 may also display the perfusion level on a display 146. In an embodiment, the perfusion assessment may be performed at the end thereof, i.e., at other stages of the procedure including after stapling.

[0058] FIG. 11 shows a linear power stapler 700 that can share a common power platform with the power circular stapler 10, i.e., a handle assembly 100 that includes one or more motors, a power source, a main controller, a memory device, a transceiver, etc. The stapler 700 also includes a linear adapter 702 configured to connect the handle assembly 100 to a loading unit 704 that includes an end effector 706 having a first jaw 708 with a stapler cartridge 710 and a second jaw 712 with an anvil 714. The linear adapter 702 includes various mechanical couplings that couple the end effector 706 to the handle assembly 100 and enable the operation of the end effector 706 to perform various functions, such as clamping, stapling, and cutting. For further details regarding the structure and operation of the components of the linear stapler, reference can be made to U.S. Patent No. 9,839,425, filed on Mar. 30, 2015, the entire content of which is incorporated herein by reference.

[0059] Referring to FIGS. 12 and 13, another embodiment of a spectroscopic assembly or NIRS system 800 is shown, which has substantially the same functionality as the NIRS system 600 but a different shape, i.e., linear versus circular. The NIRS system 800 includes a plurality of light sources 802, which may be laser diodes, configured to output NIR light that may be in the range of about 700 nm to about 900 nm. In an embodiment, the light sources 802 may also output light in the red and NIR ranges that may be in the range of about 650 nm to about 850 nm.

[0060] The NIRS system 800 operates in a similar manner to the NIRS system 600 by transmitting light from the light sources 802 through tissue intervening between the first jaw 708 and the second jaw 712 and detecting the light reflected or backscattered therefrom with a plurality of photodetectors 804. The photodetectors 804 may be photodiodes or any other suitable photosensitive element configured to operate at the spectrum of the light sources 802.

[0061] The NIRS system 800 can be disposed on one or both of the first Joe 708 and the second Joe 712. The light source 802 can be disposed on one of the Joes 708 and 712, and the photodetector 804 is disposed on the other of the Joes 708 and 712. In a further embodiment, each of the Joes may include a light source 802 and a photodetector 804, as shown in FIG. 13.

[0062] The light source 802 and the photodetector 804 may be distributed along the outer periphery of the first Joe 708. In particular, the light source 802 and the photodetector 804 are disposed on a linear flexible circuit 806 that provides an electrical connection, such as a trace, to each of the light source 802 and the photodetector 804. The flexible circuit 806 can be disposed at any position of the first Joe 708, for example, from the periphery to the inside. The flexible circuit 806 is disposed within the first Joe 708, and the staple cartridge 710 includes a plurality of openings 720 defined in the staple fastening surface 722. The openings 720 can be aligned with each of the light source 802 and the photodetector 804 to allow light transmission. The openings 720 can have any suitable depth, for example, a depth from about 0.1 mm to about 2 mm, to prevent external light from hitting the photodetector 804.

[0063] The flexible circuit 806 also includes leads 808 having a pair of electrical contacts 808a and 808b configured to optically or electrically couple to contacts (not shown) of the linear adapter 702. The linear adapter 702 or the handle assembly 100 may include an A / D converter that converts the analog signal from the photodetector 804 for transmission along the wire harness to the main controller 147. The main controller 147 is configured to process the signal from the photodetector 804 to determine the level of perfusion in the stapled tissue. In an embodiment, the photodetector 804 may be individually addressable such that perfusion can be evaluated by the main controller 147 at each location of the photodetector 804. In an embodiment, the main controller 147 may display on the display 146 a graphical user interface (GUI) indicating the degree of perfusion and / or whether the perfusion is at a desired level corresponding to the success of the stapling operation. The GUI may be displayed on any other display present in the operating room. The GUI can use color-coded indicators, such as red, yellow, green, to indicate the perfusion assessment. In embodiments having individually addressable photodetectors 804, each perfusion may be separately displayed, for example, within a segmented ring in an area corresponding to each of the addressable photodetectors 804.

[0064] In use, the linear power stapler 700 is advanced to the surgical site, for example, via an access port. The user presses the toggle control button 30 to initiate the stapling process, which first clamps the tissue between the first jaw 708 and the second jaw 712. A drive rod (e.g., an I-beam) can engage the first and second jaws 708 and 712 to move the jaws 708 and 712 closer to each other.

[0065] After the clamping is completed, the main controller 147 can start an optical verification or a baseline test before starting the stapling procedure. During cutting and stapling, the drive rod is continuously advanced, whereby the ejector (e.g., the sled) is pushed together with the knife blade to cut and staple the tissue until the ejector and / or the knife reach mechanical limits, e.g., the distal ends of the first and second jaws 708 and 712. Thereafter, the drive rod is retracted, whereby the knife is retracted, but the sled may remain in the distal position. When the drive rod is further retracted, the first and second jaws 708 and 712 are unclamped.

[0066] Prior to unclamping, the main controller 147 starts a perfusion check that includes energizing the light source 802 to irradiate the clamped tissue. The reflected or backscattered light is received by the photodetector 804, and the photodetector 804 supplies the detected signal to the main controller 147, which compares the signal to a perfusion threshold. The main controller 147 can also display the perfusion level on the display 146. In embodiments, the perfusion assessment may be performed at other stages of the procedure, i.e., after the initial clamp and before stapling.

[0067] It is understood that various modifications may be made to the stapler embodiments disclosed herein. Accordingly, the above should be construed as illustrative of embodiments and not as a limitation. Those skilled in the art may envision other modifications within the scope and spirit of the present disclosure.

[0068] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. When 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. The computer-readable medium may include a non-transitory computer-readable medium corresponding to a tangible medium such as a data storage medium (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).

[0069] The 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 gate arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Correspondingly, the term “processor” as used herein may refer to any of the foregoing structures or any other physical structure suitable for implementation of the described techniques. The techniques may also be fully implemented in one or more circuits or logic elements.

Claims

1. a stapler cartridge containing a plurality of staples; a spectroscopic assembly disposed within the stapler cartridge, the spectroscopic assembly including a plurality of light sources and a plurality of light detectors interspersed among the plurality of light sources; a controller coupled to the spectroscopic assembly, activating the plurality of light sources to illuminate tissue contacting the stapler cartridge; receiving signals from the plurality of photodetectors based on the reflected light detected by the plurality of photodetectors; determining a degree of blood perfusion in the tissue based on the signal; With a controller configured as 1. A surgical stapler including:

2. The surgical stapler of claim 1 , wherein the stapler cartridge includes a tissue contacting surface having a plurality of staple pockets that contain the plurality of staples and define a plurality of openings.

3. The surgical stapler of claim 2 , wherein the light spectroscopy assembly includes a flexible circuit having the plurality of light sources and the plurality of light detectors disposed thereon.

4. The surgical stapler of claim 3 , wherein each light source of the plurality of light sources and each light detector of the plurality of light detectors is aligned with an opening of the plurality of openings.

5. The surgical stapler of claim 4 , further comprising a tubular housing configured to removably couple to the stapler cartridge.

6. The tubular housing comprises: a connector configured to electrically or optically couple to the flexible circuit; a wire harness extending through the tubular housing and connecting the connector to the controller; 6. The surgical stapler of claim 5, comprising:

7. The surgical stapler of claim 6, wherein the connector includes at least one analog-to-digital converter configured to convert signals from the plurality of photodetectors from analog to digital.

8. The surgical stapler of claim 1 , further comprising a display configured to display a graphical user interface, the controller being further configured to output the degree of blood perfusion on the graphical user interface.

9. 1. A surgical stapler comprising: an annular reload including a stapler cartridge having a plurality of staples; an anvil assembly movable relative to the annular reload and configured to compress tissue therebetween; a knife assembly disposed within the annular reload configured to cut the tissue; a spectroscopic assembly disposed within the stapler cartridge, the spectroscopic assembly including a plurality of light sources and a plurality of light detectors interspersed among the plurality of light sources; A handle assembly comprising: at least one motor configured to actuate the anvil assembly, the stapler cartridge, and the knife assembly; and a controller coupled to the spectroscopic assembly, controlling the at least one motor; activating the plurality of light sources to illuminate the tissue contacting the stapler cartridge; receiving signals from the plurality of photodetectors based on the reflected light detected by the plurality of photodetectors; determining a degree of blood perfusion in the tissue based on the signal; A controller configured as follows: a handle assembly including:

1. A surgical stapler including:

10. The surgical stapler of claim 9, wherein the controller is further configured to control the at least one motor based on a degree of blood perfusion.

11. The surgical stapler of claim 9, wherein the stapler cartridge has an annular shape and includes a tissue contacting surface having a plurality of staple pockets containing the plurality of staples and defining a plurality of openings.

12. The surgical stapler of claim 11 , wherein the light-splitting assembly includes a flexible circuit having an annular shape on which the plurality of light sources and the plurality of light detectors are disposed.

13. The surgical stapler of claim 12, wherein each light source of the plurality of light sources and each light detector of the plurality of light detectors is aligned with an opening of the plurality of openings.

14. The surgical stapler of claim 13, further comprising a tubular housing coupled to the handle assembly, the tubular housing configured to removably couple to the stapler cartridge.

15. The tubular housing comprises: a connector configured to electrically or optically couple to the flexible circuit; a wire harness extending through the tubular housing and connecting the connector to the controller; 15. The surgical stapler of claim 14, comprising:

16. The surgical stapler of claim 15, wherein the connector includes at least one analog-to-digital converter configured to convert signals from the plurality of photodetectors from analog to digital.

17. The surgical stapler of claim 9, further comprising a display configured to display a graphical user interface.

18. The surgical stapler of claim 17, wherein the controller is further configured to output a degree of blood perfusion or oximetry on the graphical user interface.

19. 18. The surgical stapler of claim 17, wherein the controller is further configured to output a degree of blood perfusion or oximetry on the graphical user interface for each segment of the tissue corresponding to each photodetector of the plurality of photodetectors.

20. 1. A surgical stapler comprising: a first jaw including a stapler cartridge having a plurality of staples; a second jaw movable relative to the first jaw and configured to compress tissue therebetween; a spectroscopic assembly disposed within at least one of the first jaw or the second jaw, the spectroscopic assembly including a plurality of light sources and a plurality of photodetectors interspersed among the plurality of light sources; A handle assembly comprising: at least one motor configured to move at least one of the first jaw or the second jaw and to eject the plurality of staples; and a controller coupled to the spectroscopic assembly, controlling the at least one motor; activating the plurality of light sources to illuminate the tissue contacting the stapler cartridge; receiving signals from the plurality of photodetectors based on the reflected light detected by the plurality of photodetectors; determining a degree of blood perfusion in the tissue based on the signal; A controller configured as follows: a handle assembly including:

1. A surgical stapler including:

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