Real-time stapling tissue perfusion assessment

Abstract

A surgical stapler includes a staple cartridge having a plurality of staples. The surgical stapler also includes a spectral assembly disposed within the staple 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 spectral assembly. The controller is configured to activate the plurality of light sources to irradiate tissue contacting the staple cartridge with light. 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 a degree of blood perfusion in the tissue based on the signals.

Description

Technical Field

[0001] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to electromechanical surgical systems for performing suturing 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 motor-driven. There are many types of electric surgical staplers (such as linear or circular staplers) that are specifically designed to perform certain types of surgical procedures, including endoscopic procedures that provide real-time video of the surgical site through a laparoscope or endoscopic camera.

[0003] Linear staplers are used in a variety of surgical procedures, such as resection and transecting organs and other tissues. Circular staplers are used to reattach a previously transected portion of the rectum or for similar procedures. Linear staplers and circular staplers can be manually actuated or driven and can include a pistol-style or linear grip-style structure having an elongated shaft extending therefrom and a staple cartridge supported on the distal end of the elongated shaft.

[0004] For the circular stapler, the doctor can insert the anvil assembly of the circular suturing device through the incision and toward the transected rectal portion. The doctor can also insert the rest of the circular suturing device (including the cartridge assembly) into the patient's rectum and manipulate the device along the patient's colon tract toward the transected rectal portion. The anvil assembly and the cartridge assembly are moved toward each other, and the nail is discharged from the cartridge assembly toward the anvil assembly to form the nail in the tissue, thereby achieving an end-to-end anastomosis, and the annular knife is advanced to core a portion of the clamped tissue portion. After completing the end-to-end anastomosis, the circular suturing device is removed from the surgical site.

[0005] After linear or circular suturing procedures, maintaining adequate blood flow in the staple line area supports tissue recovery. Currently, there is a need for a device that can assess vascularization between staples as a measure of whether blood flow in the staple line area is adequate. Summary of the invention

[0006] The present disclosure provides an electric stapler (e.g., circular or linear) configured to form a staple line, such as a linear staple line or anastomosis, by connecting two parts of a structure (e.g., intestine, colon, etc.). The electric 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 a drive shaft, that transmit actuation from an electric handle. The electric handle assembly and the adapter assembly can be reusable.

[0007] Electric surgical staplers operate in four stages, namely clamping, suturing, cutting, and loosening. For linear staplers, clamping, suturing and cutting occur when the drive shaft advances, and loosening occurs during the drive shaft retreats.

[0008] For circular staplers, clamping is accomplished by moving the anvil in a proximal direction to compress tissue between the anvil and a reload assembly comprising a plurality of staples. The anvil and reload assembly may be disposable. During the suturing process, the staples are ejected from the reload assembly into the clamped tissue and deformed against the anvil. Cutting includes moving the annular knife through the compressed and stapled tissue until the knife contacts the anvil. During the release process, the anvil assembly moves distally away from the cut tissue and the reload assembly.

[0009] The electric stapler includes a real-time near infrared spectroscopy (NIRS) system that provides blood flow measurement in the reloader assembly to allow for estimation of tissue perfusion during suturing surgery. The NIRS system (which may also include diffuse correlation spectroscopy) is an optical method for evaluating blood flow in tissue using near infrared light (NIR) (e.g., NIR light with a wavelength from about 700nm to about 900nm). Depending on the source-detector distance, light travels through tissues of varying depths, and analysis of the collected backscattered light indicates blood flow levels within the tissue. One or more light sources and detectors may be provided within the circular stapler to allow for evaluation of tissue perfusion or blood oxygen measurement around the staple line during or after surgery.

[0010] NIRS systems according to the present disclosure can be incorporated into any surgical stapler (i.e., circular, linear, etc.) where light sources and detectors are interspersed along the staple line. In particular, light sources (which can be lasers) and detectors can be incorporated into linear and / or circular stapler designs to create a reflective photoplethysmography method to measure staple line fullness.

[0011] In an embodiment, the NIRS system may include an annular or linear flexible circuit that is disposed adjacent to, for example, behind, the nail guide of the reloader assembly. The flexible circuit may be placed along the outer row of nails, adjacent to any nail row (e.g., inner row, middle row, etc.). An LED, IR LED, combined IR and red LED, or other light source illuminates light through an opening in the nail guide, and any reflected light is returned through the tissue toward photodiodes (i.e., photodetectors) dispersed between the light sources. The light source and the photodiode may be individually addressable, allowing the fullness at a particular photodiode position to be determined.

[0012] The flexible circuit can be routed to a wiring harness that connects the NIRS system to the adapter and handle assembly. Since the analog signal transmitted along the wiring harness will be susceptible to electromagnetic interference, analog-to-digital (A / D) conversion can be performed at the far end of the adapter or on the flexible circuit itself. In an embodiment, the transmission can be completed wirelessly. In another embodiment, the signal from the photodetector can be received at a processing unit disposed in the electric handle, and the processing unit is connected to the detector through an optical fiber passing through the adapter. In an embodiment, the light source and the photodiode can be connected to an optical connector so that the light is transmitted through an optical fiber that is arranged to pass through each component (e.g., end effector, adapter, handle) of the electric surgical stapler.

[0013] According to one embodiment of the present disclosure, a surgical stapler is disclosed. The surgical stapler includes a staple cartridge having a plurality of staples. The surgical stapler also includes a spectral assembly disposed within the staple cartridge, the spectral assembly having a plurality of light sources and a plurality of photodetectors dispersed between the plurality of light sources. The surgical stapler further includes a controller coupled to the spectral assembly. The controller is configured to activate the plurality of light sources to illuminate tissue contacting the staple cartridge with light. 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 in the tissue based on the signals.

[0014] Implementations of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the staple cartridge may have a linear or annular shape and may include a tissue contact surface having a plurality of staple pits for accommodating a plurality of staples and defining a plurality of openings. The spectral 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 of the plurality of light sources and each of the plurality of photodetectors is aligned with one of the plurality of openings. The surgical stapler may include a tubular housing configured to be removably coupled to the staple cartridge. The tubular housing may include: an electrical connector configured to be electrically coupled to the flexible circuit; and a wiring harness extending through the tubular housing and connecting the electrical connector to the controller. The tubular housing may include an optical connector configured to be coupled to a plurality of light sources and a plurality of photodetectors. The optical connector is coupled to one or more optical fibers disposed in the tubular housing and is coupled to at least one analog-to-digital converter configured to convert signals from the plurality of photodetectors from analog to digital. The electrical connector may include at least one analog-to-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 show a graphical user interface. The controller may be further configured to output the blood perfusion level 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 reloader having a staple cartridge including a plurality of staples. The annular reloader also includes: an anvil assembly that is movable relative to the annular reloader and configured to compress tissue therebetween; and a knife assembly that is disposed in the annular reloader and configured to cut tissue. The annular reloader further includes a spectral assembly that is disposed in the staple cartridge and has a plurality of light sources and a plurality of photodetectors dispersed between the plurality of light sources. The surgical stapler also includes a handle assembly that has one or more motors that are configured to actuate the anvil assembly, the staple cartridge, and the knife assembly. The handle assembly also includes a controller coupled to the spectral assembly. The controller is configured to control the motor. The controller is further configured to activate a plurality of light sources to illuminate tissue contacting the staple cartridge with light. 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 in the tissue based on the signals.

[0016] Implementations of the above embodiments may include one or more of the following features. According to one aspect of the above embodiments, the controller may be further configured to control at least one motor based on the degree of blood perfusion. The staple cartridge has an annular shape and may include a tissue contact surface having a plurality of staple pits for accommodating a plurality of staples and defining a plurality of openings. The spectral 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 of the plurality of light sources and each of the plurality of photodetectors is 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 be removably coupled to the staple cartridge. The tubular housing may further include: an electrical connector configured to be electrically coupled to the flexible circuit; and a wiring harness extending through the tubular housing and connecting the electrical connector to the controller. The electrical connector may include at least one analog-to-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 show 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, on the graphical user interface, a blood perfusion level for each segment of tissue corresponding to each photodetector of the plurality of photodetectors.

[0017] According to another embodiment of the present disclosure, a surgical stapler is disclosed. The surgical stapler includes: a first jaw having a staple cartridge having a plurality of staples; a second jaw movable relative to the first jaw and configured to compress tissue therebetween. The surgical stapler also includes a spectral component disposed in at least one of the first jaw or the second jaw, the spectral component including a plurality of light sources and a plurality of photodetectors dispersed between 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 discharge a plurality of staples; and a controller coupled to the spectral component. The controller is configured to control at least one motor and activate a plurality of light sources to illuminate tissue contacting the staple cartridge with light. The controller is further configured to receive signals from a plurality of photodetectors based on reflected light detected by a plurality of photodetectors, and to determine the degree of blood perfusion in the tissue based on the signals. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which:

[0019] Figure 1is a perspective view of an electric circular stapler according to an embodiment of the present disclosure, the electric circular stapler including a handle assembly, an adapter assembly, and an end effector;

[0020] Figure 2 yes Figure 1 Schematic diagram of a handle assembly, an adapter assembly, and an end effector;

[0021] Figure 3 According to the embodiments of the present disclosure Figure 1 A side perspective view of a circular adapter assembly and end effector of the embodiment of the present invention, and an annular reloader and anvil assembly attached to the circular adapter assembly;

[0022] Figure 4 Is set in Figure 1 A perspective view of a clamping drive assembly within an adapter assembly, partially shown in phantom;

[0023] Figure 5 Is set in Figure 1 A perspective view of a suture drive assembly within an adapter assembly, partially shown in phantom;

[0024] Figure 6 Is set in Figure 1 A perspective view of a cutting drive assembly within an adapter assembly, partially shown in phantom;

[0025] Figure 7 yes Figure 1 A cross-sectional view of a circular end effector;

[0026] Figure 8 is a perspective view of a circular adapter assembly with a strain gauge assembly, the circular adapter assembly being shown partially disassembled;

[0027] Fig. 9 According to the embodiments of the present disclosure Figure 1 A perspective view of a reloader of an end effector;

[0028] Fig.10 According to the embodiments of the present disclosure Figure 1 A partially disassembled perspective view of a circular end effector;

[0029] Fig.11 is a perspective view of an electric linear stapler according to an embodiment of the present disclosure, the electric linear stapler including a handle assembly, an adapter assembly, and an end effector;

[0030] Fig.12 According to the embodiments of the present disclosure Fig.11 A perspective view of an end effector of ; and

[0031] Fig.13According to the embodiments of the present disclosure Fig.11 A partially disassembled perspective view of an end effector. DETAILED DESCRIPTION

[0032] Embodiments of the presently disclosed surgical device and adapter assembly, and / or handle assembly for a surgical device are described in detail with reference to the accompanying drawings, in which like reference numerals represent identical or corresponding elements in each of the several views. As used herein, the term "distal" refers to that portion of a surgical instrument or a component thereof that is further away from a user, and the term "proximal" refers to that portion of a surgical instrument or a component thereof that is closer to a user.

[0033] The present disclosure provides an electric stapler (i.e., linear or circular) having a handle assembly, an adapter assembly coupled to the handle assembly, and an end effector coupled to the adapter assembly. The stapler allows complete, independent control of the following three functions: clamping, suturing, and cutting. This allows certain portions of the stapler to adapt when tissue presents non-ideal conditions.

[0034] Figure 1 A surgical device, such as an electric circular stapler 10 for forming an end-to-end anastomosis ("EEA"), is shown, which includes a handle assembly 100 configured to selectively connect to an adapter assembly 200. In an embodiment, the electric stapler 10 can be a linear stapler. The adapter assembly 200 is configured to selectively connect to an end effector 300, which includes a reloader 400 and an anvil assembly 500. The end effector 300 is configured to produce a surgical effect on the patient's tissue, i.e., to connect two parts of a structure (e.g., intestine, colon, etc.) to form an anastomosis by clamping, stapling and cutting tissue grasped within the end effector 300.

[0035] The handle assembly 100 includes an electric handle 101 and an outer cover shell 11, which is configured to selectively receive and enclose the electric handle 101. The cover shell 11 includes a distal half section 11a and a proximal half section 11b pivotally connected to the distal half section 11a. The distal half section 11a and the proximal half section 11b define a cover cavity therein when connected, and the electric handle 101 is disposed in the cover cavity.

[0036] Although the electric circular stapler 10 is described herein as a modular device that includes multiple interconnected components (such as a handle assembly 100, a removable cover body 11, and an adapter assembly 200, etc.), the electric circular stapler 10 can be formed as an integrated device in which one or more components are securely attached to each other, for example during manufacture of the electric circular stapler.

[0037] The distal half-section 11a and the proximal half-section 11b of the cover body 11 are separated along a plane that passes through the longitudinal axis "X" of the adapter assembly 200. The distal half-section 11a of the cover body 11 defines a connecting portion 20 that is configured to receive a corresponding drive coupling assembly 210 ( Figure 3 ). The distal half-section 11a of the housing body 11 supports a toggle control button 30. The toggle control button 30 can be actuated in four directions (eg, left, right, up, and down).

[0038] refer to Figure 1 and Figure 2 The electric handle 101 includes a circuit board 142, a rechargeable battery 144 configured to power any electrical component of the handle assembly 100, and a plurality of motors (i.e., a first motor 152a, a second motor 152b, and a third motor 152c) connected to the battery 144. The electric handle 101 also includes a display 146. In an embodiment, the motors 152a, 152b, and 152c can be connected to any suitable power source (e.g., an AC / DC transformer) configured to provide electrical energy to the motors 152a, 152b, and 152c. Each of the motors 152a, 152b, and 152c is connected to a motor controller 143, which controls the operation of the corresponding motor 152a, 152b, and 152c, including the flow of electrical energy from the battery 144 to the motors 152a, 152b, and 152c. A main controller 147 is provided, which controls the electric handle 101. The main controller 147 is configured to execute software instructions embodying the algorithms disclosed herein, such as the clamping algorithm, the suturing algorithm, and the cutting algorithm that control the operation of the power handle 101. The main controller 147 also processes optical signals from a spectrometer assembled as described in more detail below.

[0039] The motor controller 143 includes a plurality of sensors 408a, ..., 408n, which are configured to measure the operating state of the motors 152a, 152b, 152c and the battery 144. The sensors 408a-n include strain gauges 408b, and may also include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n may measure the voltage, current, and other electrical characteristics of the electrical energy supplied by the battery 144. The sensors 408a-408n may also measure the angular velocity (e.g., rotation speed) in revolutions per minute (RPM), torque, temperature, current consumption, and other operating characteristics of the motors 152a, 152b, 152c. The sensor 408a also includes an encoder configured to count the number of revolutions or other indicators of the motors 152a, 152b, 152c, which the main controller 147 then uses to calculate the linear movement of the components that can be moved by the motors 152a, 152b, 152c. Angular velocity can be determined by measuring the rotation of the motors 152a, 152b, 152c or the drive shaft (not shown) connected to these motors and can be rotated by the motors 152a, 152b, 152c. The positions of the various axially movable drive shafts can also be determined by using various linear sensors disposed in or near the shafts, or extrapolated from RPM measurements. In an embodiment, torque can be calculated based on the adjusted current consumption of the motors 152a, 152b, 152c at a constant RPM. In other embodiments, the motor controller 143 and / or the main controller 147 can measure time and process the above values ​​as a function of time (including integration and / or differentiation), for example, to determine the rate of change of the measured values. The main controller 147 is also configured to determine the distance traveled by the various components of the adapter assembly 200 and / or the end effector 300 by counting the number of revolutions of the motors 152a, 152b, 152c.

[0040] The motor controller 143 is coupled to a main controller 147, which includes a plurality of inputs and outputs for interacting with the motor controller 143. In particular, the main controller 147 receives measured sensor signals from the motor controller 143 regarding the operating status of the motors 152a, 152b, 152c and the battery 144, and 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 accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc.) coupled to the main controller 147.

[0041] The main controller 147 is also coupled to the memory 141. The memory 141 may include volatile memory (e.g., RAM) and non-volatile memory 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, which are used during operation of the power handle 101.

[0042] The electric handle 101 includes a plurality of motors 152a, 152b, 152c, each of which includes a respective motor shaft (not explicitly shown) extending therefrom and configured to drive a respective transmission assembly. The rotation of the motor shaft caused by the respective motor serves to drive the shaft and / or gear components of the adapter assembly 200 so as to perform various operations of the handle assembly 100. In particular, the motors 152a, 152b, 152c of the electric handle 101 are configured to drive the shaft and / or gear components of the adapter assembly 200 so as to selectively cause the trocar member 274 ( Figure 4 ) is extended / retracted, and the trocar member may be fixed or removable. Extension / retraction of trocar member 274 opens / closes end effector 300 (when anvil assembly 500 is connected to trocar member 274 of trocar assembly 270), fires the annular array of staples 423 of reloader 400, and moves annular knife 444 of reloader 400.

[0043] Now go to Figure 3 and Figure 4 , the adapter assembly 200 includes an outer knob housing 202 and a tubular housing 206 extending from a distal end of the knob housing 202. The knob housing 202 and the tubular housing 206 are configured and sized to accommodate the components of the adapter assembly 200. The knob housing 202 includes an electrical connector 312 and a storage device 310 coupled to the electrical connector. The storage device 310 is configured to store various operating parameters related to the adapter assembly 200. The adapter assembly 200 is configured to convert a rotation of a coupling shaft (not explicitly shown) of the handle assembly 100 into an axial translation that can be used to operate the trocar assembly 270, the anvil assembly 500, and / or the staple driver 430 or knife assembly 440 of the reloader 400 of the adapter assembly 200.

[0044] Adapter assembly 200 further includes a trocar assembly 270 removably supported at the distal end of tubular housing 206. Trocar assembly 270 includes a trocar member 274 and a drive screw 276 operably received within trocar member 274 for axially moving trocar member 274 relative to tubular housing 206. Distal end 274b of trocar member 274 is configured to selectively engage anvil assembly 500 such that axial movement of trocar member 274 achieved by rotation of drive screw 276 causes concomitant axial movement of anvil assembly 500.

[0045] refer to Figure 4 , the clamp 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 clamp transmission assembly 240 plays the following roles: extending / retracting the trocar member 274 of the trocar assembly 270 of the adapter assembly 200; and opening / closing the anvil assembly 500 when the anvil assembly 500 is connected to the trocar member 274.

[0046] refer to Figure 5 , the adapter assembly 200 includes a suturing drive assembly 250 for interconnecting the second motor 152b and the second axially translatable drive member of the reloader 400, wherein the suturing drive assembly 250 converts and transmits the rotation of the second motor 152b into an axial translation of the external flexible belt assembly 255 of the adapter assembly 200 and further converts and transmits it into an axial translation of the nail driver 430 of the reloader 400, so as to fire the nail 423 from the reloader 400 and abut against the anvil assembly 500.

[0047] The suture drive assembly 250 of the adapter assembly 200 includes an external flexible belt assembly 255, which is fixed to the nail driver coupler 254. The second rotatable proximal drive shaft 220 is connected to the second motor 152b and is configured to actuate the nail driver coupler 254, which converts the rotational movement into the longitudinal movement. The external flexible belt assembly 255 includes a first flexible belt 255a and a second flexible belt 255b, which are laterally spaced apart and connected to a support ring 255c at the proximal ends of the first flexible belt and the second flexible belt, and connected to the proximal end of the distal pusher 255d at the distal ends of the first flexible belt and the second flexible belt. Each of the first flexible belt 255a and the second flexible belt 255b is attached to the support ring 255c and the distal pusher 255d. The external flexible belt assembly 255 further includes a first connection extension 255e and a second connection extension 255f extending proximally from the support ring 255c. First connecting extension 255e and second connecting extension 255f are configured to operably connect outer flexible band assembly 255 to staple driver coupler 254 of suture drive assembly 250 .

[0048] refer to Figure 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 reloader 400, wherein the cutting transmission assembly 260 converts and transmits the rotation of the third motor 152c into an axial translation of the external flexible belt assembly 265 of the adapter assembly 200 and further converts and transmits it into an axial translation of the knife holder 442 of the reloader 400 to advance the annular knife 444 from the reloader 400 and abut against the anvil assembly 500.

[0049] The inner flexible band assembly 265 includes a first flexible band 265a and a second flexible band 265b which are laterally spaced apart and connected to a support ring 265c at their proximal ends and to a proximal end of a support base 265d at their distal ends. Each of the first flexible band 265a and the second flexible band 265b is attached to the support ring 265c and the support base 265d.

[0050] The inner flexible band assembly 265 further includes a first connection extension 265e and a second connection extension 265f extending proximally from the support ring 265c. The first connection extension 265e and the second connection extension 265f are configured to operably connect the inner flexible band assembly 265 to the knife drive 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.

[0051] refer to Figure 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 to selectively contact and abut with the distal pusher 255d of the outer flexible belt assembly 255 of the suture drive assembly 250 of the adapter assembly 200. In operation, during the distal advancement of the outer flexible belt assembly 255, as described above, the distal pusher 255d of the outer flexible belt assembly 255 contacts the proximal end 432a of the driver adapter 432 to advance the driver adapter 432 and the driver 434 from a first or proximal position to a second or distal position. The driver 434 includes a plurality of driver members 436 that are aligned with the staple pockets 421 of the staple cartridge 420 to facilitate contact with the staples 423. Accordingly, the advancement of the driver 434 relative to the staple cartridge 420 causes the staples 423 to be ejected from the staple cartridge 420.

[0052] The knife assembly 440 of the reloader 400 includes a knife bracket 442 and an annular knife 444 fixed around the distal end 442b of the knife bracket 442. The proximal end 442a of the knife bracket 442 is configured to engage with the support base 265d of the internal flexible belt assembly. In operation, during the distal advancement of the internal flexible belt assembly 265, the support base 265d of the internal flexible belt assembly 265 is connected to the proximal end 442a of the knife bracket 442 to advance the knife bracket 442 and the annular knife 444 from a first or proximal position to a second or advanced position, thereby cutting tissue disposed between the staple cartridge 420 and the anvil assembly 500.

[0053] The forces during actuation of the cannula needle assembly 274, closing of the end actuator 300 (e.g., retraction of the anvil assembly 500 relative to the reloader 400), ejection of the nail 423 from the reloader 400, and advancement of the knife assembly 440 can be measured by the strain gauge 408b in order to monitor and control various processes (such as firing the nail 423 from the reloader 400); monitor the forces during the firing and formation of the nail 423 as the nail 423 is being ejected from the reloader 400; optimize the formation of the nail 423 as the nail 423 is being ejected from the reloader 400 (e.g., the nail curl height) for different tissue indications; and monitor and control the firing of the annular knife of the reloader 400.

[0054] refer to Figure 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 retraction of the cannula needle member 274 and the expulsion and formation of the nail 423 from the reloader 400. During the closing of the end actuator 300, when the anvil assembly 500 contacts tissue, obstacles, tissue contact surfaces of the reloader 400, nails are expelled, etc., a reaction force is applied to the anvil assembly 500, which is generally in the distal direction. This distally directed reaction force 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 electric handle 101 of the handle assembly 100. A graphic ( Figure 8 ) to provide the user with real-time information related to the firing status of the handle assembly 100.

[0055] Trocar assembly 270 is axially and rotationally fixed within tubular housing 206 of adapter assembly 200. Figure 8 , the adapter assembly 200 includes a support block 292 that is fixedly disposed within the tubular housing 206. 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.

[0056] In operation, the strain gauge 408b of the adapter assembly 200 measures and monitors the retraction of the trocar member 274, which passes through the strain gauge 408b. Since the first flexible band 255a and the second flexible band 255b also pass through the strain gauge 408b, the strain gauge 408b of the adapter assembly 200 also measures and monitors the ejection of the staples 423 from the reload 400. During clamping, stapling and cutting, a reaction force is exerted on the anvil assembly 500 and the reload 400, which is transmitted to the support block 292, which then transmits the reaction force to the strain sensor of the strain gauge 408b.

[0057] The strain sensor of strain gauge 408b may be any device configured to measure strain (a dimensionless quantity) on the object to which it is attached (e.g., support block 292) such that when the object deforms, the metal foil of the strain sensor also deforms causing a change in its resistance which is then used to calculate the load experienced by trocar assembly 270. Strain gauge 408b provides closed loop feedback to the firing / clamping load presented by the first, second, and third force / rotation transmitting / converting assemblies.

[0058] The strain sensor of strain gauge 408b then transmits the signal to main controller 147. Graphics are then displayed on display 146 of handle assembly 100 to provide the user with real-time information related to the firing status of handle assembly 100. Strain gauge 408b is also electrically connected to electrical connector 312 ( Figure 3 ). The wiring harness 314 can be any ribbon cable or any other suitable cable or wiring assembly. The distal portion 314b of the wiring harness 314 is coupled to a distal connector 322 supported in 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 be coupled to the storage device 402.

[0059] For further details about 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 July 3, 2019, the entire contents of which are incorporated herein by reference.

[0060] The reload 400 includes a storage device 402, and the circular adapter assembly 200 also includes a storage device 310 ( Figure 4 ). Storage devices 402 and 310 include non-volatile storage media (e.g., EEPROM) configured to store any data related to reload 400 and circular adapter assembly 200, respectively, including, but not limited to, usage counts, identification information, model numbers, serial numbers, nail sizes, stroke lengths, maximum actuation forces, minimum actuation forces, factory calibration data, etc. In an embodiment, the data may be encrypted and can only be decrypted by a device (e.g., master controller 147) with the appropriate key. The data may also be used by master controller 147 to authenticate circular adapter assembly 200 and / or reload 400. Storage devices 402 and 310 may be configured in a read-only mode or a read / write mode, thereby allowing master controller 147 to read data from and write data to storage devices 402 and 310.

[0061] refer to Fig. 9and Fig.10 , a spectral 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 may be in the range of about 700 nm to about 900 nm. In an embodiment, the light sources 602 may also output light in the red and NIR ranges, which may be in the range from about 650 nm to about 850 nm.

[0062] NIRS system 600 operates by transmitting light from a light source 602 into tissue interposed between reload 400 and anvil assembly 500 and detecting light reflected from the tissue at a plurality of photodetectors 604. Photodetectors 604 may be photodiodes or any other suitable light sensitive element configured to operate in the spectrum of light source 602.

[0063] The light sources 602 and the photodetectors 604 are dispersed along the outer perimeter of the reload 400. In particular, the light sources 602 and the photodetectors 604 are disposed on an annular flexible circuit 606 that provides electrical connections (e.g., traces) for each of the light sources 602 and the photodetectors 604. The flexible circuit 606 can be disposed at any location of the reload 400, for example, inward from the perimeter. The flexible circuit 606 is disposed within the staple cartridge 420, which includes a plurality of openings 426 defined in the suturing surface 428. The openings 426 can be aligned with each of the light sources 602 and the photodetectors 604 to enable light transmission. The openings 426 can have any suitable depth (e.g., from about 0.1 mm to about 2 mm) and prevent external light from illuminating the photodetectors 604.

[0064] The flexible circuit 606 also includes a lead 608 having a pair of connectors 608a and 608b that are configured to couple to the contacts 322a and 322b of the connector 322 ( Figure 8 ). The connector 322 may be electrical or optical and may include an A / D converter to convert the analog signal from the photodetector 604 for transmission along the wiring harness 314 to the main controller 147. In an embodiment, the A / D converter may be provided in the handle assembly 100.

[0065] The main controller 147 is configured to process signals from the photodetectors 604 to determine the perfusion level in the sutured tissue. In an embodiment, the photodetectors 604 may be individually addressable so that perfusion may be assessed by the main controller 147 at each location of the photodetectors 604. In an embodiment, the main controller 147 may display a graphical user interface (GUI) on the display 146 indicating the degree of perfusion and / or whether the perfusion is at a desired level corresponding to a successful suturing operation. The GUI may be displayed on any other display present in the operating room. The GUI may use color-coded indicators (e.g., red, yellow, green) to indicate perfusion assessments. In an embodiment with individually addressable photodetectors 604, perfusion for each photodetector may be displayed individually, for example, in a ring segmented into regions corresponding to each of the addressable photodetectors 604.

[0066] Before the electric circular stapler 10 is operated, the electric handle 101 is enclosed in the housing 11, and the adapter assembly 200 is coupled to the handle assembly 100. After the circular adapter assembly 200 is attached, the handle assembly 100 first verifies that the circular adapter assembly 200 is coupled to the handle assembly by establishing communication with the storage device 310 of the circular adapter assembly 200, and authenticates the circular adapter assembly 200. The data stored on the storage device 310 (e.g., the usage count) is encrypted and authenticated by the electric handle 101, and then it is determined whether the usage count stored on the storage device 310 exceeds a threshold value (e.g., if the adapter assembly 200 has been previously used). Then, the electric handle 101 performs a verification check (e.g., end-of-life check, missing trocar component 274, etc.), and calibrates the circular adapter assembly 200 after the handle assembly 100 confirms that the trocar component 274 has been attached.

[0067] The user begins the surgical procedure by positioning the adapter assembly 200 (including the trocar member 274 and the anvil assembly 500) in the colorectal or upper gastrointestinal region. The user presses the toggle control button 30 to extend the trocar member 274 until the trocar member pierces the tissue. After extending the trocar member 274, the anvil assembly 500 previously positioned by the surgeon is attached to the trocar member 274, and the user begins the process of clamping the tissue interposed between the reload 400 and the anvil assembly 500 by pressing the bottom portion of the toggle control button 30.

[0068] The electric circular stapler 10 can also initiate an optical verification or baseline test before starting a suturing procedure. The clamping process may include controlled tissue compression until a desired threshold is reached. Once the tissue is compressed, the user can initiate the suturing process by pressing a toggle control button 30. In an embodiment, the baseline test can occur after the tissue is compressed.

[0069] In an embodiment, once tissue compression is confirmed by the main controller 147, the suturing process can be started automatically. After the suturing is completed, the cutting is initiated automatically or by pressing the toggle control button 30, at which time the main controller 147 initiates a perfusion check, which includes energizing the light source 602 to illuminate the sutured tissue. The reflected light or backscattered light is received by the photodetector 604, which provides the detected signal to the main controller 147, which then compares the signal with the perfusion threshold. The main controller 147 can also display the perfusion level on the display 146. In an embodiment, the perfusion assessment can be performed at other stages of the operation, including at the end of the operation, that is, after suturing.

[0070] Fig.11 A linear electric stapler 700 is shown, which can share a common electric platform with the electric circular stapler 10, namely a handle assembly 100 including one or more motors, a power source, a main controller, a storage device, a transmitter / receiver, etc. The stapler 700 also includes a linear adapter 702, which is configured to connect the handle assembly 100 to a loading unit 704, which includes an end effector 706 having a first jaw 708 and a second jaw 712, the first jaw having a staple cartridge 710, and the second jaw having an anvil 714. The linear adapter 702 includes various mechanical linkages that couple the end effector 706 to the handle assembly 100, so that the end effector 706 can be actuated to perform various functions, such as clamping, suturing, and cutting. For further details on the construction and operation of the linear stapler components, reference can be made to U.S. Patent No. 9,839,425 filed on March 30, 2015, the entire contents of which are incorporated herein by reference.

[0071] refer to Fig.12 and Fig.13 , another embodiment of a spectroscopy assembly or NIRS system 800 is shown that is substantially similar in function to the NIRS system 600, but differs in shape, i.e., linear versus annular. 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, which may be in the range from about 650 nm to about 850 nm.

[0072] NIRS system 800 operates in the same manner as NIRS system 600 by transmitting light from a light source 802 into tissue interposed between first jaw 708 and second jaw 712 and detecting light reflected or backscattered from the tissue at a plurality of photodetectors 804. Photodetectors 804 may be photodiodes or any other suitable light sensitive element configured to operate in the spectrum of light source 802.

[0073] The NIRS system 800 can be disposed in one or both of the first jaw 708 and the second jaw 712. The light source 802 can be disposed in one of the jaws 708 and 712, wherein the photodetector 804 is disposed in the other of the jaws 708 and 712. In further embodiments, each of the jaws can include a light source 802 and a photodetector 804, such as Fig.13 shown.

[0074] The light sources 802 and the photodetectors 804 can be distributed along the outer periphery of the first jaw 708. In particular, the light sources 802 and the photodetectors 804 are disposed on a linear shape flexible circuit 806 that provides electrical connections (e.g., traces) for each of the light sources 802 and the photodetectors 804. The flexible circuit 806 can be disposed at any position of the first jaw 708, for example, inward from the periphery. The flexible circuit 806 is disposed within the first jaw 708, and the staple cartridge 710 includes a plurality of openings 720 defined in the suturing surface 722. The openings 720 can be aligned with each of the light sources 802 and the photodetectors 804 to enable light transmission. The openings 720 can have any suitable depth (e.g., from about 0.1 mm to about 2 mm) and prevent external light from irradiating the photodetectors 804.

[0075] The flexible circuit 806 also includes a lead 808 having a pair of electrical contacts 808a and 808b, which are configured to be optically or electrically coupled to contacts (not shown) of the linear adapter 702. The linear adapter 702 or the handle assembly 100 may include an A / D converter to convert analog signals from the photodetector 804 for transmission to the main controller 147 along the wiring harness. The main controller 147 is configured to process the signals from the photodetector 804 to determine the perfusion level in the sutured tissue. In an embodiment, the photodetector 804 may be individually addressable so that perfusion can be assessed by the main controller 147 at each position of the photodetector 804. In an embodiment, the main controller 147 may display a graphical user interface (GUI) on the display 146 indicating the degree of perfusion and / or whether the perfusion is at a desired level corresponding to a successful suturing operation. The GUI may be displayed on any other display present in the operating room. The GUI may use color-coded indicators (e.g., red, yellow, green) to indicate perfusion assessment. In embodiments having individually addressable photodetectors 804 , the perfusion for each photodetector may be displayed individually, for example, in a ring segmented into regions corresponding to each of the addressable photodetectors 804 .

[0076] During use, the linear electric stapler 700 is advanced to the surgical site, for example, through the access port. The user presses the toggle control button 30 to start the suturing process, which initially clamps the tissue between the first jaw 708 and the second jaw 712. The drive rod (e.g., an I-beam) can engage the first jaw 708 and the second jaw 712 to move the jaws 708 and 712 toward each other.

[0077] After clamping is completed, the main controller 147 can initiate an optical verification or baseline test before starting the suturing operation. During cutting and suturing, the drive rod is continuously advanced, which pushes the ejector (e.g., slider) together with the blade to cut and suturing tissue until the ejector and / or the knife reaches a mechanical limit, such as the distal end of the first jaw 708 and the second jaw 712. Thereafter, the drive rod is retracted, which retracts the knife, and the slider can remain in the distal position. When the drive rod is further retracted, the first jaw 708 and the second jaw 712 are released.

[0078] Prior to release, the master controller 147 initiates a perfusion check that includes energizing the light source 802 to illuminate the clamped tissue. The reflected light or backscattered light is received by the photodetector 804, which provides the detected signal to the master controller 147, which then compares the signal to the perfusion threshold. The master controller 147 may also display the perfusion level on the display 146. In an embodiment, the perfusion assessment may be performed at other stages of the procedure, i.e., after the initial clamp and before suturing.

[0079] It should be understood that various modifications may be made to the embodiments of the currently disclosed stapler. Therefore, the above description should not be interpreted as restrictive, but merely as an example of an embodiment. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

[0080] 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 codes 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 tangible media 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 can be accessed by a computer).

[0081] 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 circuits. Accordingly, the term "processor" as used herein may refer to any of the above structures or any other physical structures suitable for implementing the described techniques. In addition, these techniques may be fully implemented in one or more circuits or logic elements.

Claims

1. A surgical stapler, comprising: A staple cartridge, the staple cartridge comprising a plurality of staples; a spectroscopy assembly disposed within the staple cartridge and comprising a plurality of light sources and a plurality of photodetectors dispersed between the plurality of light sources; as well as a controller coupled to the spectroscopy assembly, the controller being configured to: activating the plurality of light sources to illuminate tissue contacting the staple cartridge with light; receiving signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors; as well as A level of blood perfusion in the tissue is determined based on the signal.

2. The surgical stapler according to claim 1, wherein: The staple cartridge includes a tissue contacting surface having a plurality of staple pockets for receiving the plurality of staples and defining a plurality of openings.

3. The surgical stapler according to claim 2, wherein: The spectroscopy assembly includes a flexible circuit, and the plurality of light sources and the plurality of photodetectors are disposed on the flexible circuit.

4. The surgical stapler according to claim 3, wherein: Each of the plurality of light sources and each of the plurality of photodetectors is aligned with one of the plurality of openings.

5. The surgical stapler of Claim 4, further comprising a tubular housing configured to be removably coupled to the staple cartridge.

6. The surgical stapler according to claim 5, wherein: The tubular housing comprises: a connector configured to electrically or optically couple to the flexible circuit; and A wiring harness extends through the tubular housing and connects the connector to the controller.

7. The surgical stapler according to 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 according to claim 1, further comprising a display configured to display a graphical user interface, wherein The controller is further configured to output the blood perfusion level on the graphical user interface.

9. A surgical stapler, comprising: an annular reloader comprising a staple 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 reloader and configured to cut the tissue; a spectroscopy assembly disposed within the staple cartridge and comprising a plurality of light sources and a plurality of photodetectors dispersed between the plurality of light sources; as well as A handle assembly, the handle assembly comprising: at least one motor configured to actuate the anvil assembly, the staple cartridge, and the knife assembly; and a controller coupled to the spectroscopy assembly, the controller being configured to: controlling the at least one motor; activating the plurality of light sources to illuminate the tissue contacting the staple cartridge with light; receiving signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors; and A level of blood perfusion in the tissue is determined based on the signal.

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

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

12. The surgical stapler according to claim 11, wherein: The spectroscopy assembly includes a flexible circuit having a ring shape, and the plurality of light sources and the plurality of photodetectors are disposed on the flexible circuit.

13. The surgical stapler according to claim 12, wherein: Each of the plurality of light sources and each of the plurality of photodetectors is aligned with one 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 being configured to be removably coupled to the staple cartridge.

15. The surgical stapler according to claim 14, wherein: The tubular housing comprises: a connector configured to electrically or optically couple to the flexible circuit; and A wiring harness extends through the tubular housing and connects the connector to the controller.

16. The surgical stapler according to 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 according to claim 17, wherein: The controller is further configured to output the blood perfusion level or blood oximetry on the graphical user interface.

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

20. A surgical stapler, comprising: a first jaw comprising a staple cartridge having a plurality of staples; a second jaw movable relative to the first jaw and configured to compress tissue therebetween; a spectroscopy assembly disposed within at least one of the first jaw or the second jaw, the spectroscopy assembly comprising a plurality of light sources and a plurality of photodetectors interspersed between the plurality of light sources; as well as A handle assembly, the handle assembly comprising: at least one motor configured to move at least one of the first jaw or the second jaw and eject the plurality of staples; and a controller coupled to the spectroscopy assembly, the controller being configured to: controlling the at least one motor; activating the plurality of light sources to illuminate the tissue contacting the staple cartridge with light; receiving signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors; and A level of blood perfusion in the tissue is determined based on the signal.

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