Endoscopic lithotripsy system with optical temperature measurement

Abstract

Systems and methods for monitoring and controlling surgical site temperature based on fluid near-infra red (NIR) light absorption spectra at the surgical site are disclosed. An exemplary system comprises an endoscopic surgical device operably coupled to an energy source for providing energy to an anatomical target at a fluid surgical site, a lighting system including an infrared light source to emit an NIR light to the anatomical target, and a controller circuit to determine fluid NIR light absorption spectra and estimate a fluid temperature using the NIR light absorption spectra. Based on the estimated fluid temperature, the controller circuit can adjust an operating parameter of the endoscopic surgical system to achieve or maintain a desired temperature at the fluid surgical environment during the procedure.

Description

ENDOSCOPIC LITHOTRIPSY SYSTEM WITH OPTICALTEMPERATURE MEASUREMENTPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 617,953, filed lanuary 5, 2024, the contents of which are incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] This invention relates generally to an endoscopic surgical system, and more specifically relates to an endoscopic lithotripsy system with optical temperature measurement.BACKGROUND

[0003] Endoscopes are typically used to provide access to an internal location of a patient so that a doctor is provided with visual access. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign objects from the body of the patient. For example, a nephroscope is used by a clinician to inspect the renal system, and to perform various procedures under direct visual control. In a percutaneous nephrolithotomy (PCNL) procedure, a nephroscope is placed through the patient’s flank into the renal pelvis. Calculi or mass from various regions of a body including, for example, urinary system, gallbladder, nasal passages, gastrointestinal tract, stomach, or tonsils, can be visualized and extracted.

[0004] Various medical instruments such as laser or plasma systems have been used for delivering surgical laser energy to various target treatment areas such as soft or hard tissue. Examples of the laser treatment include ablation, coagulation, vaporization, fragmentation, etc. In lithotripsy applications, laser has been used to break down calculi structures in kidney, gallbladder, ureter, among other stone-forming regions, or to ablate large calculi into smaller fragments. The calculi fragments may be removed via a working channel of an endoscope (e.g., an ureteroscope) or may be passed naturally by the patient following the procedure.

[0005] Heat buildup is a potentially hazardous consequence of laser irradiation of an anatomical or calculi target, particularly in cases where relatively high intensity laser output is used in the treatment, such as laser lithotripsy to ablate or fragment a calculi target of certain size, shape, hardness, or composition. Excessive heat buildup at or near the surgical site may cause thermal damage of non-targeted tissue or organs. Even with sufficient irrigation, high-power lasers can potentially induce injurious temperatures which makes in vivo real-time fluid temperature control important.SUMMARY

[0006] In vivo real-time monitoring and control of surgical site temperature can help prevent tissue thermal damage caused by heat buildup during medical procedures such as laser lithotripsy or ultrasound lithotripsy procedures. Conventionally, temperature is sensed from a surgical site using a temperature sensor. The sensed temperature is displayed to a user (e.g., a physician) during the procedure, and the user manually adjust device setting such as laser output, or temporarily turning off the laser output if the surgical site temperature reaches or exceeds a safety limit. A dedicated temperature sensor adds system complexity and cost. Manual temperature adjustment may not provide precise temperature control at the surgical site. Additionally, in some cases, adjustment of laser output intensity alone may not achieve adequate and fast temperature relief at the surgical site. In some cases, reducing laser output intensity or shutting off laser output may compromise therapy efficiency and / or extend procedure time. It should be noted that although the present document is focused on laser therapy, other suitable medical instrument or device, such as an ultrasound system, may be used for diagnostic or therapeutic purposes, which are within the scope of the present invention.

[0007] The present document describes systems, devices, and methods for monitoring and controlling surgical site temperature based on fluid near-infra red (NIR) light absorption spectra at the surgical site, and adjusting a device setting based at least in part on estimated temperature. An exemplary endoscopic surgical system comprises an endoscopic surgical device operably coupled to an energy source for providing energy to an anatomical target at a fluid surgicalenvironment, a lighting system including an infrared light source to emit an NIR light to the anatomical target, and a controller circuit to determine fluid NIR light absorption spectra in a vicinity of the anatomical target and estimates fluid temperature using the NIR light absorption spectra. Based at least in part on the estimated fluid temperature, the controller circuit can adjust an operating parameter of the endoscopic surgical system to achieve or maintain substantially a desired temperature at the fluid surgical site during the procedure. In this document, the term “substantially” means ±10%, and in some embodiments, ±5%.

[0008] The fluid NIR light absorption spectra-based temperature estimation technique as described herein does not require additional temperature sensing hardware such as a dedicated temperature sensor, thereby reducing system complexity and cost. The temperature control approach described herein may advantageously prevent or reduce the severity of tissue thermal damage due to excessive energy delivered to the tissue site (e.g., laser irradiation). Various temperature control means allow more versatile management of surgical site temperature. In particular, irrigation or suction flow and irrigant treatment, among other temperature control means, can help avoid discontinuation or reduced energy output during the procedure. Accordingly, more precise and faster temperature control and improved laser therapy efficacy and tissue safety can be achieved.

[0009] Example 1 is an endoscopic surgical system. The system includes: an endoscopic surgical device configured to operably couple to an energy source for providing energy to an anatomical target at a fluid surgical site during a procedure; a lighting system, including a first light source configured to emit a near infrared (NIR) light at a specific wavelength range to the anatomical target; and a controller circuit configured to: determine fluid NIR light absorption spectra in a vicinity of the anatomical target; estimate fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; and based at least in part on the estimated fluid temperature, adjust at least one operating parameter of the endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure.

[0010] In Example 2, the subject matter of Example 1 optionally includes the anatomical target that may include a calculi target, wherein the endoscopic surgical device is an endoscopic lithotripsy device configured to ablate or fragment the calculi target.

[0011] In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes, wherein the first light source is configured to emit the NIR light at a wavelength range of 700-1000 nanometers.

[0012] In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes, wherein to determine the fluid NIR light absorption spectra, the controller circuit is configured to detect an absorption spectral peak over the specific wavelength range, and to determine a spectral property including at least one of: an intensity of the absorption spectral peak; a wavelength corresponding to the absorption spectral peak; or a bandwidth of the absorption spectral peak.

[0013] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include the controller circuit that may be configured to determine a change or a rate of change in the estimated fluid temperature in the vicinity of the anatomical target, and to adjust the at least one operating parameter of the endoscopic surgical system based on the determined change or rate of change in the estimated fluid temperature.

[0014] In Example 6, the subject matter of Example 5 optionally includes controller circuit that may be configured to determine an increase or a rate of increase in the estimated fluid temperature in the vicinity of the anatomical target based on at least one of: an increase in absorption spectral peak intensity; a decrease in absorption spectral peak wavelength; or a narrowing of absorption spectral bandwidth.

[0015] In Example 7, the subject matter of any one or more of Examples 1-6 optionally includes the controller circuit that may be further configured to: generate a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times; and adjust the at least one operating parameter in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

[0016] In Example 8, the subject matter of Example 7 optionally includes, wherein to adjust the at least one operating parameter, the controller circuit is configured to reduce an average power of laser pulses delivered to the surgical site in response to (i) the generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) the prediction of future temperature exceeding a temperature threshold.

[0017] In Example 9, the subject matter of any one or more of Examples 1-8 optionally includes the energy source that may include at least one laser source to provide laser pulses, wherein the at least one operating parameter to be adjusted includes a laser output setting of the at least one laser source, wherein the controller circuit is configured to generate a control signal to the at least one laser source to deliver the laser pulses in accordance with the adjusted at least one operating parameter.

[0018] In Example 10, the subject matter of Example 9 optionally includes, wherein to adjust the laser output setting, the controller circuit is configured to, in response to the estimated fluid temperature exceeding a temperature threshold, reduce an average power of the laser pulses delivered to the anatomical target, including reducing at least one of a pulse width, a peak power, or pulse frequency of the laser pulses.

[0019] In Example 11, the subject matter of any one or more of Examples 9-10 optionally include, wherein to adjust the laser output setting, the controller circuit is configured to, in response to estimated fluid temperature exceeding a temperature threshold, at least temporarily disable the at least one laser source from delivering the laser pulses to the anatomical target.

[0020] In Example 12, the subject matter of any one or more of Examples 1-11 optionally includes an irrigation and / or suction system configured to provide irrigant into, and suction of fluid from, the anatomical target during the procedure, wherein to adjust the at least one operating parameter, the controller circuit is configured to increase at least one of an irrigation flow or a suction flow via the irrigation and / or suction system in response to the estimated fluid temperature exceeding a temperature threshold.

[0021] In Example 13, the subject matter of Example 12 optionally includes an irrigant treatment unit configured to alter a temperature of theirrigant, wherein the controller circuit is configured to, based at least in part on the estimated fluid temperature, generate a control signal to the irrigant treatment unit to adjust a temperature of the irrigant before reaching the anatomical target.

[0022] In Example 14, the subject matter of any one or more of Examples 1-13 optionally includes the lighting system that may further include a second light source configured to emit a visible light to the anatomical target, the visible light having a wavelength range different from the wavelength range of the NIR light, wherein the controller circuit is further configured to: determine a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target; identify a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target; and adjust the at least one operating parameter of the endoscopic surgical system based at least in part on the identified type or composition of the anatomical target.

[0023] In Example 15, the subject matter of Example 14 optionally includes, wherein the second light source is configured to emit the visible light at a wavelength range of 400-700 nanometers.

[0024] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include the controller circuit that may be configured to, in response to the estimated fluid temperature exceeding a temperature threshold, enable the energy source to: deliver the energy to the anatomical target if the anatomical target is identified as a calculi target; and at least temporarily disable the energy source from delivering the energy to the anatomical target if the anatomical target is identified as an anatomical tissue to protect tissue from injury.

[0025] In Example 17, the subject matter of any one or more of Examples 14-16 optionally includes the controller circuit that may be configured to synchronize emission of the NIR light and the visible light respectively from the first light source and the second light source.

[0026] Example 18 is a modular endoscopic surgical system. The system includes: an endoscopic surgical device configured to operably access an anatomical target at a fluid surgical site during a procedure; and modular devices detachably coupled to, or operatively communicate with, the endoscopic surgicaldevice, the modular devices including: an energy source configured to provide energy to the anatomical target; at first light source configured to emit a near infrared (NIR) light at a specific wavelength range to the anatomical target; a feedback analyzer module configured to determine fluid NIR light absorption spectra in a vicinity of the anatomical target; a temperature monitor module configured to estimate fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; and a controller module configured to, based at least in part on the estimated fluid temperature, adjust at least one operating parameter of the modular endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure.

[0027] In Example 19, the subject matter of Example 18 optionally includes the modular devices that may further include a second light source configured to emit a visible light to the anatomical target, the visible light having a wavelength range different from the wavelength range of the NIR light, wherein the feedback analyzer module is further configured to determine a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target, and to identify a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target, wherein the controller module is configured to adjust the at least one operating parameter of the modular endoscopic surgical system further based on the identified type or composition of the anatomical target.

[0028] In Example 20, the subject matter of any one or more of Examples 18-19 optionally includes the energy source that may include at least one laser source configured to provide laser pulses to the anatomical target, wherein to adjust the at least one operating parameter, the controller module is configured to adjust a laser output setting of the at least one laser source, and to generate a control signal to the at least one laser source to deliver the laser pulses in accordance with the adjusted at least one operating parameter.

[0029] In Example 21, the subject matter of Example 20 optionally includes, wherein to adjust the laser output setting, the controller module is configured to, in response to the estimated fluid temperature exceeding atemperature threshold, reduce an average power of the laser pulses delivered to the anatomical target, including reducing at least one of a pulse width, a peak power, or a pulse frequency of the laser pulses.

[0030] In Example 22, the subject matter of any one or more of Examples 18-21 optionally includes the temperature monitor module that may be further configured to generate a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times, Wherein the controller module is configured to adjust the at least one operating parameter further in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

[0031] In Example 23, the subject matter of any one or more of Examples 18-22 optionally include, further comprising an irrigation and / or suction system configured to provide irrigant into, and suction of fluid from, the anatomical target during the procedure, wherein the controller module is configured to adjust the at least one operating parameter including at least one of an irrigation flow or a suction flow to be adjusted via the irrigation and / or suction system.

[0032] Example 24 is a method for monitoring and controlling temperature at a fluid surgical site of a patient during an endoscopic procedure using an endoscopic surgical system. The method includes steps of: directing a near infrared (NIR) light at a specific wavelength range from a first light source to an anatomical target at a fluid surgical site; determining fluid NIR light absorption spectra in a vicinity of the anatomical target via a feedback analyzer; estimating fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; based at least in part on the estimated fluid temperature, adjusting at least one operating parameter of the endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure; and providing energy to the anatomical target at the fluid surgical site via an energy source.

[0033] In Example 25, the subject matter of Example 24 optionally includes further steps of: directing a visible light from a second light source to the anatomical target, the visible light having a wavelength range different fromthe wavelength range of the NIR light; determining a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target; and identifying a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target; wherein adjusting the at least one operating parameter of the endoscopic surgical system is further based on the identified type or composition of the anatomical target.

[0034] In Example 26, the subject matter of any one or more of Examples 24-25 optionally includes, wherein the energy provided to the anatomical target includes laser pulses generated by at least one laser source, wherein adjusting the at least one operating parameter includes adjusting a laser output setting of the at least one laser source, wherein the laser pulses are delivered to the anatomical target in accordance with the adjusted at least one operating parameter.

[0035] In Example 27, the subject matter of any one or more of Examples 24-26 optionally includes generating a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times, wherein adjusting the at least one operating parameter is further in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

[0036] In Example 28, the subject matter of any one or more of Examples 24-27 optionally includes adjusting the at least one operating parameter which may include, in response to the estimated fluid temperature exceeding a temperature threshold, reducing an average power of laser pulses delivered to the surgical site via at least one laser system, including reducing at least one of a pulse width, a peak power, or a pulse frequency of the laser pulses.

[0037] In Example 29, the subject matter of any one or more of Examples 24-28 optionally includes adjusting the at least one operating parameter which may include, via an irrigation and / or suction system, increasing at least one of an irrigation flow of irrigant into the surgical site or a suction flow of fluid out of the surgical site, in response to the estimated fluid temperature exceeding a temperature threshold.

[0038] Various embodiments of the temperature monitoring and control system as described in this document may be used to in procedures involving different energy sources (e.g., laser, radio-frequency (RF), or ultrasound), including lithotripsy, procedures in urology area such as RF prostate resection or Transurethral Resection Prostate (TURP) surgery, or Non-Muscle Invasive Bladder Cancer resection (NMIBC), among others. In these procedures, saline fluid is used to create a working environment for RF cutting and vaporizing electrodes. Heat produced by the RF devices may cause temperature rise in the fluid environment that may potentially damage the tissue, at least in part due to the small nature of the environment (e.g., in prostate resection procedures). The temperature monitoring and control systems and methods as described in this document can effectively and efficiently prevent overheating of the fluid environment and ensure tissue safety during the procedure.

[0039] This summary is an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Various embodiments are illustrated by way of example in the figures of the accompanying drawings. Such embodiments are demonstrative and not intended to be exhaustive or exclusive embodiments of the present subject matter.

[0041] FIG. l is a block diagram illustrating an example of a laser energy delivery system configured to provide laser treatment to an anatomical target at or near a surgical site.

[0042] FIG. 2 is a block diagram illustrating an endoscopic surgical system with in vivo surgical site temperature monitoring and control, and at least a portion of the environment in which the system may operate.

[0043] FIG. 3 illustrates an example of an endoscopic laser lithotripsy system with automatic surgical site temperature monitoring and control.

[0044] FIG. 4 illustrates by way of example a portion of a fluid absorption spectra at specific wavelength ranges obtained in response to NIR light and visible light incident on a calculi target.

[0045] FIG. 5 illustrates an NIR absorption spectra of pure water measured as a function of temperature.

[0046] FIGS. 6A-6K illustrate, by way of example and not limitations, modularized endoscopic systems each comprising one or more of the devices or functional blocks as described above with respect to FIGS. 2 and 3.

[0047] FIG. 7 illustrates an exemplary computer-based clinical decision support system (CDSS) that is configured to determine a proper laser output setting based on estimated temperature and target identification results.

[0048] FIG.8 is a flowchart illustrating a method for monitoring and controlling temperature at a fluid surgical site during an endoscopic procedure.

[0049] FIG. 9 is a block diagram illustrating an example machine upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform.DETAILED DESCRIPTION

[0050] An endoscopic procedure is a medical procedure of viewing and operating on an internal organ, and / or delivering energy (e.g., laser energy or ultrasound energy) to a target body region to achieve a particular diagnostic or therapeutic effect. For example, laser endoscopy have been used for treatment of soft and hard tissue (e.g., damaging or destroying cancer cells), or in lithotripsy applications. During the procedure, a practitioner can insert a scope through an incision in a patient’s ureter and into the patient’s kidney. Through the scope, the practitioner can locate certain stones in the kidney or upper ureter, break the stones into smaller fragments by illuminating the stone, through the scope, with relatively high-powered infrared laser beam. The laser beam can ablate a stoneinto smaller fragments. The stone fragments can then be withdrawn from the kidney. The scope can include an endoscope, a nephroscope, and / or a cystoscope.

[0051] Laser energy delivered to the environment of the surgical site and laser treatment of anatomical target (e.g., ablation and fragmentation of a calculi target) may cause heat buildup at or near the surgical site, particularly in cases where relatively high intensity laser output is used, such as to ablate or fragment a calculi target of certain size, hardness, or composition. In an example of endoscopic laser lithotripsy, laser emission can induce significant temperature rise in calyceal fluid. For example, studies of laser lithotripsy procedures have found that extended laser treatment may cause thermal injury towards ureter and kidney tissue. Ideally the temperature should be maintained below a safe range below 43 °C, and higher fluid temperature can damage the non-targeted renal tissue. Even with sufficient irrigation, high-power laser settings can potentially induce injurious temperatures which makes in vivo real-time fluid temperature control important.

[0052] To prevent hazardous consequences such as tissue thermal damage, intracorporeal or surgical-site temperature can be monitored during the procedure to ensure it remains within a safe temperature range. Conventionally, temperature is sensed from a surgical site using a dedicated temperature sensor, such as a thermistor, a thermocouple, or other microelectromechanical system (MEMS) based temperature sensors. The sensed temperature is displayed to a user (e.g., a physician) during the procedure. The user can manually change an energy source setting (e.g., laser output intensity), or temporarily turning off the energy source, if the surgical site temperature reaches or exceeds a safety limit. However, a dedicated temperature sensor adds the system complexity and cost. Manual temperature adjustment also has several limitations. First, since the surgical site temperature can rise quickly especially when high laser output is used during the procedure, reducing or shutting off laser output when the temperature reading reaches or exceeds a safety limit may be too late to prevent laser-induced tissue thermal damage. Second, timing of laser output adjustment is critical for preventing tissue damage without compromising ablation or fragmentation efficiency. Manual adjustment of laser output not only puts onuson the operating physician, but may lack precision and predictability, particularly for inexperienced physicians. Third, reducing or shutting off laser output may not produce adequate and fast temperature relief at certain surgical sites or tissue anatomy. In some cases, it is not feasible to shut off or significantly reduce laser output without compromising ablation efficiency. For at least the above reasons, the present inventors have recognized an unmet need for devices and methods for automatic and more effective temperature control to prevent heat buildup at surgical site during a procedure such as a laser lithotripsy or ultrasound lithotripsy procedure.

[0053] The present document describes systems, devices, and methods for in vivo temperature monitoring and control based on fluid NIR light absorption spectra, and automatically adjusting a device setting based at least in part on estimated temperature. According to one embodiment, an exemplary endoscopic surgical system comprises an endoscopic surgical device operably coupled to an energy source configured to provide energy to an anatomical target at a fluid surgical site during a procedure, a lighting system including an infrared light source to emit a near infrared (NIR) light to the anatomical target, and a controller circuit to determine fluid NIR light absorption spectra and estimate a fluid temperature in the vicinity of the anatomical target using the NIR light absorption spectra. Based on the estimated fluid temperature, the controller circuit can adjust an operating parameter of the endoscopic surgical system to achieve or maintain substantially a desired temperature at the fluid surgical environment during the procedure.

[0054] The systems, devices, and methods according to various embodiments discussed herein improve non-invasive, in vivo surgical site temperature control during a laser endoscopy procedure. Features described herein may further be used in regard to an endoscope, laser surgery, laser lithotripsy or ultrasound lithotripsy, irradiation parameter settings, and / or spectroscopy. Examples of targets and applications may include laser lithotripsy or ultrasound lithotripsy of renal calculi and laser incision or vaporization of soft tissue. In an example of endoscopic system that incorporate the features as described herein, surgical site temperature may be monitored in vivo and in substantially real time based on spectroscopic analysis of NIR light absorptionspectra. Compared to conventional temperature monitoring and control techniques, the optical, NIR light absorption spectra-based temperature as described herein allows timely detection of excessive heat buildup at the surgical site, such that more effective preventive actions may be taken well before the temperature rises to a critical level, thereby preventing tissue thermal damage and improving patient safety.

[0055] The present document describes various temperature control means to regulate surgical site temperature, such as keeping the temperature below a critical level or within a desired safety range. In one example, laser output intensity or one or more laser irradiation parameters (e.g., one or more laser pulse parameters such as, power, duration, frequency, or pulse shape, exposure time, or firing angle) may be adjusted. Additionally or alternatively, irrigation inflow into the surgical site and / or outflow (suction) out of the surgical site may be regulated to put the surgical site temperature under control. In some embodiments, irrigant can be treated (e.g., chilled) before flowing into the surgical site to more quickly and effectively reduce the surgical site temperature. Compared to conventional approach that focuses on controlling laser output, the various temperature control means and the tiered temperature control strategy as discussed in this document advantageously allows for more versatile control of surgical site temperature in accordance with the surgical site conditions. Using alternative temperature control means such as irrigation or suction flow and irrigant treatment can help avoid discontinuation or substantial reduction of laser energy output during a laser lithotripsy procedure, such that laser therapy efficacy would not be significantly compromised. Consequently, more precise and faster temperature control and improved laser therapy efficacy and tissue safety may be achieved.

[0056] According to some embodiments, a single spectrometer may be used to provide both NIR light absorption spectra-based temperature measurement and spectral -based target identification (e.g., for identifying target type or composition). Spectral contents at different respective wavelength ranges may be analyzed to obtain temperature estimates and information about target characteristics. With the use of a single spectrometer as described herein, thesystem complexity and cost can be greatly reduced without compromising the performances of temperature measurement and target identification.

[0057] FIG. l is a block diagram illustrating an example of a laser energy delivery system 100 configured to provide laser treatment to an anatomical target at or near a surgical site of the target structure 122 in a body of a subject, such as anatomical structure (e.g., soft tissue, hard tissue, or abnormal such as cancerous tissue) or calculi structure (e.g., kidney or pancreobiliary or gallbladder stone). In some examples, the laser energy delivery system 100 may deliver precisely controlled therapeutic treatment of tissue or other anatomical structures (e.g., tissue ablation, coagulation, vaporization, or the like) or treatment of non-anatomical structures (e.g., ablation or dusting of calculi structures).

[0058] The laser energy delivery system 100 can include a feedback control system 101, and at least one laser system 102 in operative communication with the feedback control system 101. By way of example and not limitation, FIG. 1 shows the laser feedback system connected to a first laser system 102 and optionally (shown in dotted lines) to a second laser system 104. Additional laser systems are contemplated within the scope of the present disclosure. The first laser system 102 may include a first laser source 106, and associated components such as power supply, display, cooling systems and the like. The first laser system 102 may also include a first optical pathway 108 operatively coupled with the first laser source 106. In an example, the first optical pathway 108 includes an optical fiber. The first optical pathway 108 may be configured to transmit laser beams from the first laser source 106 to the target structure at or near a surgical site of the target structure 122.

[0059] The feedback control system 101 may receive feedback signals 130 from the target. Various feedback signals may be used to control laser delivery, laser energy output, and / or other system parameters to improve therapy efficacy and to achieve or maintain a desired condition such as a desired temperature at or near the surgical site to prevent or reduce the severity of laser- induced tissue thermal damage. In an example, the feedback signals 130 may include signals indicative of surgical site condition such as a temperature at or near the surgical site during the procedure. In an example, the feedback signals130 may include an acoustic signal produced by a laser pulse propagating through the media (e.g., liquid and vapor), projecting to the target and causing the target to vibrate. In another example, the feedback signals 130 may include reflected electromagnetic signal (e.g., reflected illumination light emitted from a light source). In yet another example, the feedback signals 130 may include reflected laser signal. The feedback control system 101 may analyze the feedback signals 130, generate signal properties from the feedback signals 130, and control laser output (e.g., energy intensity, or other laser irradiation parameters such as power, duration, frequency, or pulse shape, exposure time, or firing angle) or other system parameters according to the signal properties. In an example where the feedback signals 130 are indicative of surgical site conditions such as temperature during the procedure, the feedback control system 101 may generate a temperature trend or a prediction of future temperature at the surgical site using the feedback signals 130. The feedback control system 101 may adjust laser output or laser delivery and / or other system parameters to achieve or maintain a desired surgical site condition, such as a desired surgical site temperature during the procedure to prevent or reduce the severity of laser- induced tissue thermal damage.

[0060] As shown in FIG. 1, based on the analysis of the feedback signals 130, the feedback control system 101 may control the first laser system 102 and / or the second laser system 104 to generate suitable laser outputs to achieve a desired therapeutic effect and to achieve or maintain a desired condition such as a desired temperature at or near the surgical site to prevent or reduce the severity of laser-induced tissue thermal damage. For instance, the feedback control system 101 may monitor properties of the target structure during a therapeutic procedure (e.g., ablating calculi such as kidney stones into smaller fragments) to determine if the tissue was suitably ablated prior to another therapeutic procedure (e.g., coagulation of blood vessels).

[0061] In an example, the first laser source 106 may be configured to provide a first output 110. The first output 110 may extend over a first wavelength range, such as one that corresponds to a portion of the absorption spectrum of the target structure at the surgical site of the target structure 122. The first output 110 may provide effective ablation and / or carbonation of thetarget structure since the first output 110 is over a wavelength range that corresponds to the absorption spectrum of the tissue.

[0062] In an example, the first laser source 106 may be configured such that the first output 110 emitted at the first wavelength range corresponds to high absorption (e.g., exceeding about 250 cm’1) of the incident first output 110 by the tissue. In example aspects, the first laser source 106 may emit first output 110 between about 1900 nanometers (nm) and about 3000 nm (e.g., corresponding to high absorption by water) and / or between about 400 nm and about 520 nm (e.g., corresponding to high absorption by oxy- hemoglobin and / or deoxy-hemoglobin). Appreciably, there are two main mechanisms of light interaction with a tissue: absorption and scattering. When the absorption of a tissue is high (absorption coefficient exceeding 250 cm’1) the first absorption mechanism dominates, and when the absorption is low (absorption coefficient less than 250 cm’1), for example lasers at 800-1100 nm wavelength range, the scattering mechanism dominates.

[0063] Various commercially available medical-grade laser systems may be suitable for the first laser source 106. For instance, semiconductor lasers such as InXGal-XN semiconductor lasers providing the first output 110 in the first wavelength range of about 515 nm and about 520 nm or between about 370 nm and about 493 nm may be used. Alternatively, infrared (IR) lasers such as those summarized in Table 1 below may be used.Table 1 Example List of suitable IR lasersLaser Wavelength Absorption Coefficient Optical Penetration Depth (n s (cnr1) 8 (pm)Thulium fiber laser: 1908 88 / 150 114 / 67Thulium fiber laser: 1940 120 / 135 83 / 75Thulium: YAG: 2010 62 / 60 161 / 167Holmium:YAG: 2120 24 / 24 417 / 417ErbitsnrYAG: 2940 12.000 / 1.000 1 / 10

[0064] The optional second laser system 104 may include a second laser source 116 for providing a second output 120, and associated components, such as power supply, display, cooling systems and the like. The second laser system 104 may either be operatively separated from or, in the alternative, operatively coupled to the first laser source 106. In some embodiments, the second laser system 104 may include a second optical pathway 118 (separate from the first optical pathway 108) operatively coupled to the second laser source 116 fortransmitting the second output 120. Alternatively, the first optical pathway 108 may be configured to transmit both the first output 110 and the second output 120.

[0065] In certain aspects, the second output 120 may extend over a second wavelength range, distinct from the first wavelength range. Accordingly, there may not be any overlap between the first wavelength range and the second wavelength range. Alternatively, the first wavelength range and the second wavelength range may have at least a partial overlap with each other. In advantageous aspects of the present disclosure, the second wavelength range may not correspond to portions of the absorption spectrum of the target structure where incident radiation is strongly absorbed by tissue that has not been previously ablated or carbonized. In some such aspects, the second output 120 may advantageously not ablate uncarbonized tissue. In another embodiment, the second output 120 may ablate carbonized tissue that has been previously ablated. In additional embodiments, the second output 120 may provide additional therapeutic effects. For instance, the second output 120 may be more suitable for coagulating tissue or blood vessels.

[0066] FIG. 2 is a block diagram illustrating an endoscopic surgical system 200 with in vivo surgical site temperature monitoring and control, and at least a portion of the environment in which the system 200 may operate. The system 200 can be an embodiment of the laser energy delivery system 100, or a lithotripsy system that may be used for destructing hardened masses like kidney stones, bezoars, gallstone, among other calculi structures. The system 200 can monitor and control the temperature of the surgical site of the target structure 122 during the procedure, such that the surgical site temperature can be maintained at substantially a desired level during a procedure to prevent or reduce the severity of laser-induced tissue thermal damage.

[0067] The endoscopic surgical system 200 may include a feedback control system 210, a light source 201, one or more sensors including a spectroscopic sensor 220, a laser system 230, an irrigation and / or suction system 240, and a user interface device 250. The feedback control system 210, which is an embodiment of the feedback control system 101 of the laser energy delivery system 100, may include a spectral analyzer 212, a temperature estimator circuit216, a target identification circuit 217, and a controller circuit 218. According to example embodiments, the feedback control system 210 may include processors, such as microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components for performing one or more of the functions attributed to the feedback control system 210.

[0068] The spectral analyzer 212 may be communicatively coupled to one or more sensors, including a spectroscopic sensor 220. The spectroscopic sensor 220 may sense a spectroscopic signal in response to light from the light source 201 incident on the target structure 122. The light source 201 may be configured to produce near infrared (NIR) light 202 and visible light 204. By way of example and not limitation, the spectroscopic sensor 220 may include a Fourier Transform Infrared (FTIR) spectrometer, a Raman spectrometer, a UV- VIS spectrometer, a UV-VIS-IR spectrometer, or a fluorescent spectrometer, among others. Each spectroscopic sensor 220 corresponds to a spectroscopy technique. For example, UV-VIS reflection spectroscopy may be used to gather information from the light reflected off an object similar to the information yielded from the eye or a color image made by a high resolution camera, but more quantitatively and objectively. The reflection spectroscopy may offer information about the material since light reflection and absorption depends on its chemical composition and surface properties. Information about both surface and bulk properties of the sample may be obtained using this technique. The reflection spectroscopy may be used to recognize composition of hard or soft tissue. Fluorescent spectroscopy is a type of electromagnetic spectroscopy that analyzes fluorescence from a sample. It involves using a beam of light, usually ultraviolet, that excites a material compound and causes the material compound to emit light, typically in visible or IR area. The method may be applied for analysis of some organic components such as hard and soft tissue. FTIR spectroscopy may be used for rapid materials analysis, and has relatively good spatial resolution and gives information about the chemical composition of the material. Raman spectroscopy may be used for identifying hard and soft tissue components. As a high spatial resolution technique, it is also useful fordetermining distribution of components within a target. The spectroscopy techniques as described above may be used alone or in combination to analyze the spectroscopic signal by the spectroscopic sensor 220 to generate one or more spectroscopic properties indicative of structure types with respective distinct compositions.

[0069] In some example, the light source 201 may include a first lightemitting diode (LED) to emit NIR light 202, and a second LED to emit visible light 204 for illumination and visual inspection of the target structure 122 and the surrounding environment. The NIR light 202 and the visible light 204 have different wavelengths or wavelength ranges. In a non-limiting example, the NIR light 202 has a wavelength in a range of approximately 700-1000 nanometers (nm), the visible light 204 has a wavelength in a range of approximately 400-700 nm. The NIR light 202 and the visible light 204 may be transmitted through respective different optical pathways. Alternatively, the NIR light 202 and the visible light 204 may be transmitted through one common optical pathway. In response to the NIR light 202 and the visible light 204 incident on the target structure 122, the spectroscopic sensor 220 may sense a spectroscopic signal from the target structure 122, and the spectral analyzer 212 may determine fluid absorption spectra using the spectroscopic signal. Referring to FIG. 4, the diagram therein illustrates by way of example at least a portion of a fluid absorption spectra 400 over a specific wavelength ranges in response to NIR light and visible light incident on a calculi target. As illustrated in FIG. 4, the fluid absorption spectra 400 includes a first spectral content 410 over the visible light’s wavelength (e.g., approximately 400-700 nm), and a second spectral content 420 over the NIR light’s wavelength (e.g., approximately 700-1000 nm). The second spectral content 420 represents the amount of NIR light absorption by the fluid in the vicinity of the target structure 122, hence also referred to as fluid NIR light absorption spectra 213, as shown in FIG. 2. The first spectral content 410 at the 400-700 nm range represents the target structure’s spectroscopic property 214.

[0070] The spectral analyzer 212 may generate one or more spectral features from the sensed spectroscopic signal. Examples of the spectroscopic features may include characteristics such as reflectivity, reflectance spectrum,absorption index, and the like. In an example, first one or more spectral features may be generated from the target structure’s spectroscopic property 214 (e.g., the first spectral content at the 400-700 nm range). The first one or more spectral features may be provided to the target identification circuit 217 for target detection and identification. In an example, second one or more spectral features may be generated from the NIR light absorption spectra 213 (e.g., the second spectral content at the 700-1000 nm range). The NIR light absorption spectral features may be provided to the temperature estimator circuit 216 to estimate a temperature or a change in temperature at the vicinity of the target structure 122.

[0071] The temperature estimator circuit 216 may estimate a temperature, or a change or a rate of change in temperature at the vicinity of the anatomical target, and to adjust an operating parameter of the endoscopic surgical system based on the determined change or rate of change in the estimated fluid temperature. Referring to FIG. 5, the diagram 500, reprinted from “Non-invasive tissue temperature measurements based on quantitative diffuse optical spectroscopy (DOS) of water” by Chung et al., Physics In Medicine and Biology, 55 (2010) 3753-3765, illustrates an NIR absorption spectra of pure water as a function of temperature, which varies from 15-65 °C. Each absorption spectrum at a specific temperature can be represented by spectral intensities (1 / millimeter) over a range of wavelengths (e.g., 650-1100 nm range, as shown in FIG. 5). A spectral peak can be identified typically within a 800-1100 nm range. Spectral features of water NIR absorption spectra may vary with the temperature and water binding state. At the initial test temperature, the water NIR absorption spectrum peaks at approximately 970 nm. As temperature increases, the water NIR absorption spectral peak intensity increases from Si to S2, the spectral bandwidth (which can be determined as the width at a level of X% of the peak intensity where X is greater than 0 and less than 100, e.g., 75%) narrows from Di to D2, and the spectral peak wavelength decreases from Wi to W2 (a phenomenon also known as a “blue shift”, as a reduction in peak wavelength corresponds to an increase in peak frequency). The data demonstrates a correlation between NIR absorption spectral features (e.g., spectral peak intensity, spectral peak wavelength, or spectral bandwidth) and temperature, which forms the basis of the spectra-based temperature estimation.Based on such an established correlation, the temperature estimator circuit 216 may estimate a change in fluid temperature at the vicinity of the target structure 122 using characteristic changes in one or more absorption spectral features derived from the fluid NIR light absorption spectra 213, such as a an increase in spectral peak intensity, a decrease in spectral peak wavelength, or a narrowing in spectral bandwidth.

[0072] In some examples, the temperature estimator circuit 216 can predict a future temperature at the vicinity of the anatomical target at a specified future time based on the measured temperatures at different times, under the assumption that the laser energy applied to the surgical site and the heat dissipation mechanisms (e.g., natural, or artificially applied such as via irrigation flow or other means of surgical site temperature control) remain unchanged. In an example, the temperature estimator circuit 216 may generate a prediction model using the plurality of temperature measurements, and generate a prediction of future temperature using the prediction model. The prediction model can be generated using techniques such as curve and surface fitting, time series regression, or machine learning (ML) approaches. The prediction model can be generated through a model training process using a training dataset including surgical site temperatures measured at different times and a model type. The training process includes algorithmically adjusting model parameters (e.g., weights assigned to nodes of an input layer, output layer, or any hidden layers of a neural network model) until a convergence criteria or a training stopping criterion is satisfied. The prediction model can include a linear prediction model in one example, or a non-linear prediction model in another example, in which the surgical site temperature can be modeled to have a linear relationship or a nonlinear relationship with time. In an example, the temperature estimator circuit 216 may predict a future temperature using a temperature trend, or a rate of temperature change indicating an amount of change in temperature over a unit time period, such as a temperature rising rate at or near the surgical site. In an example, a linear temperature trend may be generated using a regression analysis of temperature measurements at past times. As will be discussed further below, the temperature trend or the prediction of future temperature may be used to feedback control of laser output or other systemparameters to achieve or maintain substantially a desired temperature at the surgical site during the procedure.

[0073] The target identification circuit 217 may identify the target structure 122 as one of a plurality of structure types of the same category, such as a particular tissue type within an identified category of anatomical structure, or as a particular calculi type within an identified category of calculi structure, based at least in part on the target spectroscopic property 214, which may be derived from the first spectral content 410 at 400-700 nm range as shown in FIG. 4. In an example, the spectral analyzer 212 may identify a calculi structure as one of stone types with distinct chemical compositions, such as one of a CaP stone, a MAP stone, a COM stone, a COD stone, a cholesterol-based stone, a cystine stone, or a uric acid (UA) stone. The target identification may be made based on one or more of spectroscopic properties or acoustic properties, such as intensity, power, frequency or spectral content, or a graphical feature or shape of the received spectroscopic or acoustic signal, or one or more statistical features generated from the received signal. In some example, the spectral analyzer 212 may identify an identified anatomical structure as one of plurality of tissue types. The tissue types may include tissue at distinct anatomical locations, such as calyx tissue, cortex tissue, medulla tissue, or ureter tissue. In another example, the spectral analyzer 212 may identify an anatomical structure as normal tissue or abnormal tissue (e.g., cancerous tissue). In another example, the spectral analyzer 212 may identify an anatomical structure as a treatment area (e.g., tumor or polyp intended for removal) or a non-treatment area (e.g., blood vessels, muscle, etc.).

[0074] In various examples, one or more of the temperature estimator circuit 216 or the target identification circuit 217 may use artificial intelligence (Al) or machine learning (ML) based techniques to perform respective tasks such as to estimate a temperature or a change or a rate of change in temperature at the vicinity of the anatomical target, or to identify target type or composition, respectively. For example, the NIR light absorption spectra 213 may be applied to a first trained ML model to automatically estimate a temperature or a change or a rate of change in temperature, and / or the target spectroscopic property 214 may be applied to a second trained ML model to automatically identify targettype or composition or other characteristics during the procedure. Examples of the ML model used for recognizing anomaly from endoscopic images or video streams include Convolutional Neural Networks, bi-directional LSTM, Recurrent Neural Networks, Conditional Random Fields, Dictionary Learning, or other machine learning techniques (support vector machine, Bayesian models, decision trees, k-means clustering), among other ML techniques. The trained ML model may be stored in a storage device.

[0075] The controller circuit 218 may be coupled by wired or wireless connections to the temperature estimator circuit 216 and the target identification circuit 217. The controller circuit 218 may adjust at least one operating parameter associated with the endoscopic surgical system to achieve or maintain substantially a desired temperature at the fluid surgical environment during the procedure. In an example, the controller circuit 218 may compare the monitored surgical site temperature against a specific temperature range, such as the upper “safe-operating” temperature limit. When the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), the controller circuit 218 may adjust one or more system parameters, such as laser energy output via the laser system 230 and / or irrigation flow via the irrigation and / or suction system 240. For example, if the surgical site temperature satisfies a criterion that warrants temperature adjustment (e.g., if the temperature rising rate (e.g., + 0.8°C / sec) exceeds a rate threshold (e.g., +0.5°C / sec), or if the estimated temperate exceed the “safe-operating” temperature limit, then the controller circuit 218 can automatically, or prompt the user to manually, adjust one or more system parameters to prevent or reduce the severity of laser-induced tissue thermal damage, as to be further discussed below. In some examples, the controller circuit 218 may adjust at least one operating parameter to achieve or maintain substantially a desired temperature at the surgical site during the procedure based at least in part on the temperature trend or the prediction of future temperature. For example, the controller circuit 218 may adjust at least one operating parameter to reduce laser output in response to the generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or in response to the prediction of future temperature exceeding a temperature threshold.

[0076] According to some embodiments, a single spectrometer, such as the spectroscopic sensor 220, may sense the spectroscopic signal containing a first spectral content over the visible light’s wavelength (e.g., approximately 400-700 nm) and a second spectral content over the NIR light’s wavelength (e.g., approximately 700-1000 nm). NIR light absorption spectra-based temperature measurement and spectral-based target identification may be performed using respective spectral contents at distinct wavelength ranges. With the use of a single spectrometer as described herein, the system complexity and cost can be greatly reduced without compromising the performances of temperature measurement and target identification.

[0077] The laser system 230, which is an example of the laser system 102 or the laser system 104 as shown in FIG. 1, can include a laser source (such as the first laser source 106) and an optical pathway (such as the first optical pathway 108) for directing the laser energy to the surgical site. The laser source can generate laser energy in accordance with a laser output intensity or one or more laser irradiation parameters (e.g., one or more laser pulse parameters such as, power, duration, frequency, or pulse shape, exposure time, or firing angle). At least some of the laser parameters are programmable or adjustable either automatically such as by the controller circuit 218, or manually by a user via the user interface device 250. When the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), the controller circuit 218 can automatically adjust a laser output setting in accordance with the estimated temperature at the surgical site (as provided by the temperature estimator circuit 216) and / or the results of target identification (as provided by the target identification circuit 217). For example, when the surgical site temperature satisfies a temperature adjustment criterion (the temperature rising rate exceeds a rate threshold, or if the estimated temperature exceeds the “safe-operating” temperature limit, then the controller circuit 218 may automatically reduce average power of laser pulses delivered to the surgical site, such as by reducing one or more of a pulse width of a laser pulse, a peak power of a laser pulse, or a pulse frequency representing a number of laser pulses per unit time. Reducing the average power of laser pulses can decreasethe laser-induced heating effect at or near the surgical site, thereby preventing tissue thermal damage and improving patient safety during the procedure.

[0078] In addition or alternative to adjusting one or more laser output parameters, the controller circuit 218 may automatically select one of a plurality of pre-determined laser output settings or pulse profiles with different energy output levels based at least on the estimated surgical site temperature. In an example, the controller circuit 218 may automatically toggle between at least a first “high output” setting and a second “low output” setting with respective predetermined parameter values. The “low output” setting has a lower average power than the “high output” setting. When the surgical site temperature satisfies the temperature adjustment criterion, the laser output setting can be automatically switched to “low output” setting. In certain examples where a radiofrequency source or an acoustic / ultrasound source is provided as an alternative or additional energy source other than the laser system 230, the output of such alternative or additional sources may be similarly adjusted to achieve or maintain the temperature at the fluid site within a saft-operating or desired temperature range.

[0079] In some examples, when the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), the controller circuit 218 may generate a control signal to an actuator coupled to an optical pathway (e.g., a laser fiber) of the laser system 230 to adjust the position or orientation of a distal portion (laser firing portion) of the optical pathway relative to the anatomical target at or near the surgical site. The adjustment of the position or orientation of the distal portion of the optical pathway can include adjusting a distance between the distal portion and the anatomical target (the “fiber-target” distance), or an aiming angle of the distal portion with respect to the anatomical target, in accordance with the estimated surgical site temperature. For example, when the surgical site temperature satisfies a temperature adjustment criterion (e.g., the temperature rising rate exceeds a rate threshold, or the estimated temperature exceeds the “safe-operating” temperature limit), the controller circuit 218 may automatically, via the actuator, move the distal portion of the optical pathway farther away from the surgical site (i.e., increase the fiber-target distance) and / or rotating thedistal portion of the optical pathway to aim the laser away from the surgical site (to increase the aiming angle). By increasing the fiber-target distance and / or increasing the aiming angle, the density of the laser energy incident on the surgical site and the laser-induced heat transferred into the surgical site can be reduced.

[0080] The irrigation and / or suction system 240 may include one or more irrigation and / or suction sources that can provide a flow of irrigation fluid (also referred to as irrigant, e.g., saline solution) to the surgical site through at least one irrigation channel such as included in an endoscope during the procedure. The irrigation fluid can facilitate removal of the tissue debris, stone fragments, and other unwanted matters through a suction channel. The irrigation flow also has a cooling effect on the tissue at or near the surgical site and the surgical tools (e.g., endoscopic tissue removal device), and can help dissipate the heat generated during ablation of calculi. Examples of the irrigation and / or suction system 240 are discussed below with reference to FIG. 3.

[0081] When the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), the controller circuit 218 may automatically adjust one or more irrigation parameters, such as an irrigation flow or a suction flow, in accordance with the estimated temperature at the surgical site. For example, when the surgical site temperature satisfies a temperature adjustment criterion, the controller circuit 218 may automatically increase the irrigation flow from the irrigation source to the surgical site to increase convective heat transfer. Additionally or alternatively, the controller circuit 218 can automatically increase the suction flow (or suction pressure) to more effectively withdraw the fluid away from the surgical site to improve heat dissipation and reduce the surgical site temperature.

[0082] In some examples, the irrigation and / or suction system 240 may include an irrigant treatment unit that can adjust the temperature of the irrigation fluid (irrigant) before being applied to the surgical site. When the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), the controller circuit 218 can generate a control signal to the irrigant treatment unit to alter the temperature of the irrigant in accordance with the estimated temperature at the surgical site. In an example,the irrigant treatment unit can include a cooling system (e.g., a radiator, or an inline chiller). When the surgical site temperature satisfies a temperature adjustment criterion, the cooling system can, under the control of the controller circuit 218, cool the irrigant before reaching the surgical site. In another example, the irrigant treatment unit includes a fluid mixer. If the temperature rising rate exceeds a rate threshold, or if the estimated temperature exceeds the “safe-operating” temperature limit, the fluid mixer can, under the control of the controller circuit 218, mix at least two irrigant sources of different temperatures before reaching the surgical site. The cooled irrigate via the cooling system or the mixed irrigant via the fluid mixer, when applied to the surgical site can improve convective heat transfer therein and effectively and efficiently reduce the surgical site temperature.

[0083] In various examples, the controller circuit 218 may use Al or ML based techniques to adjust the operation of the system including, for example, laser setting, irrigation, and / or suction, among other system operating parameters. For example, the estimated temperature (from the temperature estimator circuit 216) and information of target identification (from the target identification circuit 217) may be applied to a trained ML model to automatically determine a proper laser setting, or an irrigation and / or suction setting to be used during the procedure. Examples of using a trained ML model to determine a laser setting are discussed below with respect to FIG. 7.

[0084] The user interface device 250 may be operatively in communication with the feedback control system. The user interface device 250 can include an output / di splay unit 252 to display information including, for example, spectroscopic information sensed by the spectroscopic sensor 220, NIR light absorption spectra-based surgical site temperature estimates provided by the temperature estimator circuit 216, target detection and identification results provided by the target identification circuit 217, and current device settings such as the laser output setting or irrigation or suction flow rates, etc. The output / di splay unit 252 can display UI elements including visual elements, alerts, tactile feedback, or any combination thereof. The output / di splay unit 252 can generate an alert about potentially hazardous condition at or near the surgical site, such as an elevated temperature satisfying a temperature adjustmentcriterion that warrants preventive temperature adjustment. The alert can be presented in an audible, visible, tactile, or otherwise human-perceptible format. In an examples, the output / di splay unit 252 can display a countdown timer, a progress bar, or other UI element to graphically and / or textually represent the safe-operation time window, and recommend the user to adjust one or more system parameters (e.g., lowering the laser output or increasing irrigation and / or suction) to prevent overheating at the surgical site.

[0085] The user interface device 250 can include one or more input units 254 to receive user programming of the device, such as parameter values that define the temperature adjustment criterion (e.g., the “safe-operating” temperature limit), and user input to adjust laser output setting, irrigation or suction flow parameters, among other device parameters for controlling surgical site temperature. In some examples, the output / di splay unit 252 may generate a recommendation for taking preventive actions to prevent tissue damage, such as recommended adjustment of laser output or other system parameters. A user may provide an input via the one or more input units 254 to confirm, reject, or modify the recommended adjustment.

[0086] FIG. 3 illustrate an example of an endoscopic laser lithotripsy system 300 with automatic surgical site temperature monitoring and control, which can be an example of the endoscopic surgical system 200. The endoscopic laser lithotripsy system 300 may include an endoscope 301, a feedback control system 310, an actuator 338, an irrigation and / or suction system 340, an irrigant treatment unit 342. The endoscope 301 has a proximal portion and an elongate distal portion configured to be inserted into a surgical site of a patient during an endoscopic laser lithotripsy procedure. The endoscope 301 may provide visual inspection or treatment of soft (e.g., non-calcified) or hard (e.g., calcified) tissue as well as for visualizing or breaking up or otherwise treating kidney stones or other stones or other targets. As illustrated in FIG. 3, the endoscope 301 may include or provide visualization and illumination optics, such as a visualization optical pathway 360 and an illumination optical pathway 350, each of which may extend longitudinally along the elongate body of the endoscope 301. An eyepiece or camera or imaging display may be provided at or coupled to the visualization optical pathway 360 to permit user or machine visualization of atarget region at or near a distal end of the endoscope 301. The target region may be illuminated by light 370, such as provided by at least one light source 324 at a proximal end of the illumination optical pathway 350 and emitted from a distal end of the illumination optical pathway 350. The at least one light source 324 may include, for example, a Xenon lamp, a light-emitting diode (LED), a laser diode (LD), or any combination thereof.

[0087] In an example, the at least one light source 324 may include two or more light sources that emit light having different illumination characteristics, referred to as illumination modes. In an example, the illumination modes may include a white light illumination mode, or a special light illumination mode such as a narrow band imaging mode, an auto fluorescence imaging mode or an infrared imaging mode. A special light illumination can concentrate and intensify specific wavelengths of light, for example, resulting in a better visualization of tissue or other structures at the surgical site.

[0088] In an example, the at least one light source 324 may include at least a first infrared light source configured to emit a NIR light at a specific wavelength range, and a second visible light source configured to emit a visible light at a wavelength range different from the wavelength range of the NIR light. In an example, the infrared light source and the visible light source are distinct light-emitting diodes (LEDs). In a non-limiting example, the first light source can emit NIR light in a range of approximately 700-1000 nanometers (nm), the second light source can emit visible light in a range of approximately 400-700 nm. The NIR light and the visible light may be transmitted through respective different optical pathways. Alternatively, the NIR light and the visible light may be transmitted through one common optical pathway. The controller circuit 318 may synchronize emission of the visible light and the NIR light from respective light sources.

[0089] The lithotripsy system 300 may include or be coupled to at least one laser source 332, which may be an example of the first laser source 106, the second laser source 116, or the laser source included in the laser system 230. The laser source 332 may be mechanically and optically connected to an optical pathway 334, which may include a single optical fiber or a bundle of optical fibers. The optical pathway 334, which is an embodiment of the first opticalpathway 108 or the second optical pathway 118, or the optical pathway included in the laser system 230, may be introduced via a proximal access port to extend within a working channel or other longitudinal passage or lumen of the endoscope 301 or similar instrument.

[0090] The lithotripsy system 300 may include one or more sensors to sense information from the anatomical target or the surgical site, including a spectroscopic sensor 220. As described above with reference to FIG. 2, the spectroscopic sensor 220 may sense a spectroscopic signal in response to the NIR light 202 and the visible light 204 incident on the target structure 122. The spectroscopic sensor 220 may be located at a distal end 336 of the optical pathway 334. Alternatively, the spectroscopic sensor 220 may be located at other locations, such as a distal end 346 of an irrigation and / or suction channel 344.

[0091] The irrigation and / or suction system 340 (an embodiment of the irrigation and / or suction system 240) may include an irrigation source and a suction source, each fluidly coupled to a working channel of the endoscope 301, such as an irrigation and / or suction channel 344. The irrigation and / or suction channel 344 can be a common, unified channel for conducting irrigation inflow and suction outflow at different times. Alternatively, in some examples, the irrigation and / or suction channel 344 can comprise two separate channels, such as an irrigation channel and a suction channel. The separate irrigation channel and the suction channel may be parallel to each other, or coaxially disposed with a common axis, such as in a nested configuration. The irrigation source may function to provide irrigation fluid (irrigant) to the irrigation and / or suction channel 344. The irrigation fluid may be gravity fed or pressurized. In an example, a pump may produce pressurized irrigation flow through the irrigation and / or suction channel 344 into the surgical site. The suction source may function to pull, suck, draw, aspirate, or otherwise move or remove fluid and unwanted matters from the surgical site to a receptacle. The suction source may perform the aforementioned functions by generating and applying vacuum, suction, or negative pressure to the irrigation and / or suction channel 344.

[0092] The feedback control system 310 may receive feedback information including the spectroscopic signal from the spectroscopic sensor 220. The feedback control system 310 may a feedback analyzer 312 and acontroller circuit 318. The feedback analyzer 312, which is an embodiment of the spectral analyzer 212 and the temperature estimator circuit 216 and the target identification circuit 217, may perform spectral analysis of the received spectroscopic signal, and estimate a temperature at the surgical site based on the fluid NIR light absorption spectra (e.g., the second spectral content 420 at the 700-1000 nm wavelength range as shown in FIG. 4). The controller circuit 318 (an embodiment of the controller circuit 218) can determine whether the monitored surgical site temperature falls within a specific temperature range (e.g., below an upper “safe-operating” temperature limit), and satisfies a temperature adjustment criterion indicating the rise in temperature at or near the surgical site warrants temperature adjustment to prevent tissue thermal damage, as described above with reference to FIG. 2. If the temperature adjustment criterion is met, the controller circuit 318 can automatically, or prompt the user to manually, adjust one or more system parameters to regulate the surgical site temperature to prevent or reduce the severity of laser-induced tissue thermal damage.

[0093] Various temperature control means can be used to regulate surgical site temperature during a procedure. In an example, the controller circuit 318 can generate a control signal to the laser source 332 to automatically adjust a laser output setting, such as average power of laser pulses delivered to the surgical site, such as by reducing one or more of a pulse width of a laser pulse, a peak power of a laser pulse, or a pulse frequency representing a number of laser pulses per unit time. In another example, the controller circuit 318 can generate a control signal to an actuator 338 to adjust a position of a laser emitting end relative to the target at the surgical site. The actuator 338 can be coupled to a portion of the optical pathway 334, and can be in electrical communication with the controller circuit 318. In an example, the actuator 338 may be located at or near the distal end of the endoscope 301. The actuator 338 may include one or more of an electromagnetic element, an electrostatic element, a piezoelectric element, or other actuating element such as to actuate or otherwise permit longitudinal or rotational positioning of the distal end 336 of the optical pathway 334 with respect to the working channel or other longitudinal passage of the endoscope 301, or with respect to another reference location for which theendoscope 301 may serve as a frame of reference. In response to the control signal from the controller circuit 318, the actuator 338 can adjust the position or orientation of a distal end 336 of the optical pathway 334, such as adjusting the longitudinal position by moving the distal end 336 farther away from the surgical site (to increase the fiber-target distance), and / or adjusting the rotational position by steering the distal end 336 away from the surgical site (to increase the aiming angle).

[0094] In yet another example, the controller circuit 318 can generate a control signal to the irrigation and / or suction system 340 to automatically adjust one or more irrigation parameters, such as an irrigation flow or a suction flow. The irrigation flow or suction flow can help dissipate the heat generated during the procedure (e.g., laser treatment of tissue or calculi fragmentation). The irrigation flow or a suction flow may also assist in removal of fluid and unwanted matters (e.g., tissue debris or stone fragments). When the monitored surgical site temperature falls within a specific temperature range (e.g., below an upper “safe-operating” temperature limit), and satisfies the temperature adjustment criterion, the controller circuit 318 can control the irrigation and / or suction system 340 to automatically increase the irrigation flow into the surgical site to increase convective heat transfer, and / or increase the suction flow (or suction pressure) to withdraw the fluid away from the surgical site to improve heat dissipation and reduce the surgical site temperature.

[0095] In another example, the controller circuit 318 can generate a control signal to the irrigant treatment unit 342 to automatically adjust the temperature of the irrigant before being applied to the surgical site. The irrigant treatment unit 342 can include a cooling system (e.g., a radiator, or an in-line chiller) to cool the irrigant, or a fluid mixer to mix at least two irrigant of different temperatures. When the monitored surgical site temperature falls within a specific temperature range (e.g., below an upper “safe-operating” temperature limit), and satisfies the temperature adjustment criterion, the controller circuit 318 can control the irrigation and / or suction system 340 to automatically cool the irrigant via the cooling system or the fluid mixer. The irrigant / suction system 340 can then apply the cooled irrigate to the surgical site via the irrigation and / orsuction channel 344 to improve convective heat transfer therein and effectively and efficiently reduce the surgical site temperature.

[0096] The feedback analyzer 312 may additionally identify target type and composition based on the target spectroscopic properties (e.g., the spectral content 420 at the 400-700 nm wavelength range as shown in FIG. 4). For example, the feedback analyzer 312 may recognize the target as a calculi target or anatomical target at or near the surgical site, or classify the target as one type of tissue or one type of calculi of distinct composition using the one or more spectroscopic properties. In some examples, the feedback analyzer 312 may calculate or estimate the fiber-target distance using the spectroscopic properties. The controller circuit 318 may generate a control signal to the laser source 332 to adjust a laser output setting, a control signal to the actuator 338 to adjust the position or orientation of the distal end 346 of an irrigation and / or suction channel 344 (e.g., the fiber-tissue distance, or an aiming angle), or a control signal to the irrigation and / or suction system 340 to adjust irrigation flow or suction flow, based on the structure, composition, or type of the target.

[0097] In some examples, the lithotripsy system 300 can include a camera or imaging device 325 to collect imaging signal reflected from the target in response to electromagnetic radiation (e.g., illumination light 370) of the target at or near the surgical site. The imaging signal may be transmitted to the feedback analyzer 312 through the optical pathway 360. Alternatively, the imaging signal reflected from the target or the surgical site may be transmitted through the optical pathway 334. An optical splitter may direct the reflected imaging signal to the feedback analyzer 312. The feedback analyzer 312 may use the imaging signal to determine target location. The imaging signal may also be used to assist in target identification, such as identifying a calculi target or anatomical target at or near the surgical site, or classify the target as one type of tissue or one type of calculi of distinct composition using the one or more spectroscopic properties. In some examples, the feedback analyzer 312 may calculate or estimate the fiber-target distance using the spectroscopic properties. The controller circuit 318 may generate a control signal to the laser source 332 to adjust a laser output setting, a control signal to the actuator 338 to adjust the position or orientation of the distal end 346 of an irrigation and / or suctionchannel 344 (e.g., the fiber-tissue distance, or an aiming angle), or a control signal to the irrigation and / or suction system 340 to adjust irrigation flow or suction flow, based on the structure, composition, or type of the target.

[0098] FIGS. 6A-6K illustrate, by way of example and not limitations, modularized endoscopic systems each comprising one or more of the devices or functional blocks as described above with respect to FIGS. 2 and 3. FIG. 6A illustrates an example endoscopic surgical system 600A comprising a surgical endoscope 610 with a distal probe operably inserted into an fluid anatomical environment 601 of a target structure 122. The surgical endoscope 610 may include connection ports configured to be detachably coupled to one or more devices or functional modules including a video processing unit (VPU) 622 to process endoscopic images or video stream collected during the procedure, a light source 624 (an example of the light source 201 of FIG. 2), a laser system 626 (an example of the laser system 230 of FIG. 2), and a spectral analyzer 628 (an example of the spectral analyzer 212 of FIG. 2). In an example, the light source 624 may include an infrared light source configured to emit NIR light to the target structure 122, and a visible light (illumination) source configured to emit visible light to the target structure 122. The infrared light source may be located next to the visible light (illumination) source, as illustrated in FIG. 3. Alternatively, the infrared light source may be located elsewhere such as associated with or proximal to other device components.

[0099] FIG. 6B illustrates another example endoscopic surgical system 600B, which is a variant of the system 600A. In this example, the VPU 622 can be integrated into or combined with the light source 624 to form a unified “VPU- light source” device 632. The surgical endoscope 610 is detachably coupled to the unified VPU-light source device 632, as well as the laser system 626 and the spectral analyzer 628.

[0100] FIG. 6C illustrates an example endoscopic monitor system 600C, which is a variant of the system 600B. In this example, the surgical endoscope 610 is detachably coupled to the unified “VPU-light source” device 632, and the spectral analyzer 628. Unlike the surgical system 600B that can provide endoscopic laser treatment to a target structure, the monitor system 600C does not include the laser system 626. The monitor system 600C may be usedprimarily as a patient monitor and diagnostic device, such as to monitor surgical site temperature or a change in temperature, and to identify target type or composition.

[0101] FIG. 6D illustrates an example endoscopic surgical system 600D, which is a variant of the system 600A. In this example, the laser system 626 is integrated into or combined with the spectral analyzer 628 are to form a unified “laser-spectral analyzer” device 646. The surgical endoscope 610 is detachably coupled to the unified laser-spectral analyzer device 646, as well as the VPU 622 and the light source 624.

[0102] FIG. 6E illustrates an example endoscopic surgical system 600E, which is a variant of the system 600C or the system 600D. In this example, the surgical endoscope 610 is detachably coupled to the unified laser-spectral analyzer device 646 (as illustrated in FIG. 6D) and the unified VPU-light source device 632 (as illustrated in FIG system. 6C).

[0103] FIG. 6F illustrates another example endoscopic surgical system 600F, which is a variant of the system 600A. In this example, the VPU 622, the light source 624, and the spectral analyzer 628 can all be integrated or combined together into a unified “VPU-light source-spectral analyzer” device 656. The surgical endoscope 610 is detachably coupled to the unified VPU-light source- spectral analyzer device 656, as well as the laser system 626.

[0104] FIG. 6G illustrates another example endoscopic surgical system 600G, which is a variant of the system 600A. In this example, the VPU 622, the light source 624, the laser system 626, and the spectral analyzer 628 are all integrated or combined together to form a unified “VPU-light source-spectral analyzer-laser system” 666. The surgical endoscope 610 is detachably coupled to the unified VPU-light source-spectral analyzer-laser system 666.

[0105] FIG. 6H illustrates an example endoscopic monitor system 600H, which is a variant of the system 600A. In this example, the VPU 622, the light source 624, and the spectral analyzer 628 are integrated or combined together into a unified “VPU-light source-spectral analyzer” 676. The monitor system 600H does not include the laser system 626. Instead of being used for laser treatment of a target structure, the monitor system 600H may be used primarilyas patient monitor and diagnostic device such as to monitor the surgical site temperature or change in temperature, and to identify target type or composition.

[0106] FIG. 61 illustrates an example endoscopic monitor system 6001, which is a variant of the system 600H. In addition to the unified “VPU-light source-spectral analyzer” 676 as illustrated in FIG. 6H, the monitor system 6001 may include a fluid pump system 680. The fluid pump system 680, as an embodiment of the irrigation / suction system 340 of FIG. 3, can include an irrigation source to provide irrigant into the surgical site of the target structure, and a suction source to provide suction of fluid from the surgical site. The irrigation and suction can help achieve or maintain substantially a desired temperature at the fluid surgical environment during the procedure, in addition to facilitating removal of tissue or calculi fragments. As described above with respect to FIG. 3, one or more operating parameters, such as an irrigation flow and / or a suction flow, may be controllably adjusted during the procedure. In some examples, the fluid pump system 680 may include an irrigant treatment unit configured to alter a temperature of the irrigant. Based at least in part on the fluid temperature at the surgical site, the irrigant treatment unit may cool the irrigant before it reaches the target structure.

[0107] The fluid pump system 680 may be fluidly coupled to the surgical endoscope 610 to provide irrigation and / or suction when needed. The fluid pump system 680 may be communicatively coupled to the unified VPU-light source- spectral analyzer 676, such that when the VPU decides that the surgical site temperature reaches a critical value and / or when the a particular target type or composition is identified, the fluid pump system 680 may responsively be activated to provide proper irrigation or suction.

[0108] FIG. 6J illustrates an example endoscopic surgical system 600J, which is a variant of the system 6001. In addition to the unified “VPU-light source-spectral analyzer” 676 and the fluid pump system 680, the surgical endoscope 610 may further be coupled to the laser system 626 to provide surgical laser treatment of the target structure. Unlike the monitor system 600H which is used primarily as patient monitor and diagnostic device, the system 600J can provide feedback controlled laser treatment to the target structure.

[0109] FIG. 6K illustrates an example endoscopic surgical system 600K, which is a variant of the system 600A. In this example, similar to the system 600F of FIG. 6F, the VPU 622, the light source 624, and the spectral analyzer 628 can all be integrated or combined into a unified “VPU-light source-spectral analyzer” device 656, which can be detachably coupled to the surgical endoscope 610. The system 600K additionally includes a robotic surgery system 690 that can be coupled to a robotic surgical endoscope 612 (a variant of the surgical endoscope 610) to provide at least partially robotic manipulation of the endoscope 612 during the procedure. The robotic surgery system 690 may include an energy source, such as a laser source included in the laser system 626, a radiofrequency source, or acoustic / ultrasound source, among other energy sources.

[0110] FIG. 7 is a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 710 that is configured to determine a proper laser output setting based on estimated temperature and target identification results (hereinafter the “input features”). In various embodiments, the CDSS 710 includes an input interface 712 through which the input features which are specific to a patient are provided to a trained ML model 714 (also referred to as an Al model). The controller circuit 218 (shown in FIG. 2) performs an inference operation in which the input features are applied to the ML model 714 to generate a laser output setting as an inference output at the output interface 716. The inference output may be output to an output device 740, which may include a user interface (UI) through which the laser output setting can be communicated to a user, e.g., a clinician, or to a controller device such as the controller circuit 218 for performing a desired action.

[0111] In some embodiments, the input interface 712 may be a direct data link between the CDSS 710 and one or more feature generating devices 730 that generate at least some of the input features. For example, the input interface 712 may transmit the input features directly to the CDSS 710 during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 712 may be a classical user interface that facilitates interaction between a user and the CDSS 710. For example, the input interface 712 may facilitate a user interface through which the user may manually enter atleast some of the input features. Additionally, or alternatively, the input interface 712 may provide the CDSS 710 with access to a database of electronic patient record 720 from which one or more input features may be extracted. In any of these cases, the input interface 712 is configured to collect one or more of the image or video frames or features in association with a specific patient on or before a time at which the CDSS 710 is used to determine a proper laser output setting.

[0112] The controller circuit 218 may perform an inference operation using the ML model 714 to generate a proper laser output setting. For example, input interface 712 may deliver the one or more input features into an input layer of the ML model 714 which propagates these input features through the ML model 714 to an output layer. The ML model 714 can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The ML model 714 explores the study and construction of algorithms (e.g., machinelearning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an ML model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments, such as determining or adjusting the laser output setting, as stated above.

[0113] The trained ML model is able to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The ML model explores the study and construction of algorithms (e.g., ML algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building the ML model from training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0114] The ML model may be trained using supervised learning or unsupervised learning. Supervised learning uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised learning is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the samerelationships when given inputs to generate the corresponding outputs. Unsupervised learning is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised learning is useful in exploratory analysis because it can automatically identify structure in data.

[0115] Common tasks for supervised learning are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values. Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM). Examples of DNN include a convolutional neural network (CNN), a recurrent neural network (RNN), a deep belief network (DBN), or a hybrid neural network comprising two or more neural network models of different types or different model configurations.Some common tasks for unsupervised learning include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised learning algorithms are K-means clustering, principal component analysis, and autoencoders.

[0116] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0117] The training of the ML model may be performed continuously or periodically, or in near real time as additional procedure data are made available. The training process involves algorithmically adjusting one or more ML modelparameters (e.g., weights or bias at any particular layer of a neural network model), until the ML model being trained satisfies a specified training convergence criterion. By way of example and not limitation, the ML model may be trained with weighted square loss (for explicit feedback) or with binary cross-entropy loss (for implicit feedback). Other training techniques, such as deep factorization machine, wide and deep learning, deep structured semantic models, or autoencoder based recommender systems, may be used. Then, during the inference operation, the patient specific input features provided to the ML model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the laser output setting. During and / or subsequent to the inference operation, the laser output setting may be communicated to the user via the user interface (UI) and / or automatically cause the controller circuit 218 for performing a desired action.

[0118] FIG. 8 is a flowchart illustrating a method 800 for monitoring and controlling temperature at a fluid surgical site during an endoscopic procedure, such as one for treating an anatomical target (e.g., soft tissue, hard tissue, cancerous tissue, or a calculi structure such as kidney or pancreobiliary or gallbladder stone). The method 800 may be implemented in and executed by the endoscopic surgical system 200, or the endoscopic laser lithotripsy system 300. Although the processes of the method 800 are drawn in one flowchart, they are not required to be performed in a particular order. In various examples, some of the processes may be performed in a different order than that illustrated herein.

[0119] At step 810, a near infrared (NIR) light at a specific wavelength range may be directed from a first light source to an anatomical target at a fluid surgical site. In a non-limiting example, the NIR light has a wavelength of approximately 700-1000 nanometers (nm).

[0120] At step 820, fluid NIR light absorption spectra may be determined in a vicinity of the anatomical target, as by using the spectroscopic signal collected by a spectroscopic sensor in response to the NIR light incident on the anatomical target, as described above with respect to FIGS. 2 and 3.

[0121] At step 830, spectral analysis of the received spectroscopic signal may be performed to estimate a temperature at the surgical site based on the fluid NIR light absorption spectra. As illustrated in FIG. 5, a correlation can beestablished between the temperature and certain NIR light absorption spectral features (e.g., spectral peak intensity, spectral peak wavelength, or spectral bandwidth). In an example, a change or a rate of change in the estimated fluid temperature in the vicinity of the anatomical target may be determined, such as based on one or more of an increase in absorption spectral peak intensity, a decrease in absorption spectral peak wavelength, or a narrowing of absorption spectral bandwidth.

[0122] In various examples, artificial intelligence (Al) or machine learning (ML) based techniques may be used to estimate a temperature or a change or a rate of change in temperature at the vicinity of the anatomical target. For example, NIR light absorption spectra may be applied to a trained ML model to automatically estimate a temperature or a change or a rate of change in temperature. Examples of the ML model used for recognizing anomaly from endoscopic images or video streams include Convolutional Neural Networks, bidirectional LSTM, Recurrent Neural Networks, Conditional Random Fields, Dictionary Learning, or other machine learning techniques (support vector machine, Bayesian models, decision trees, k-means clustering), among other ML techniques. The trained ML model may be stored in a storage device.

[0123] At 840, based at least in part on the estimated fluid temperature, at least one operating parameter of the endoscopic surgical system may be adjusted to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure. Various temperature control means may be attempted, including, for example, changing a laser output setting or one or more laser irradiation parameters, adjusting the position or orientation of the distal portion of the optical pathway (e.g., a laser fiber), activating or adjusting an irrigation flow into the surgical site and / or a suction flow away from the surgical site, or altering the temperature of the irrigant before being applied to the surgical site, among other means, as described above with reference to FIGS. 2 and 3. In an example, the monitored surgical site temperature may be compared against a specific temperature range, such as the upper “safe-operating” temperature limit. When the measured surgical site temperature is within the specific temperature range (e.g., below the “safe-operating” temperature limit), one or more system parameters, such as laser energy output or an irrigation flowor suction flow, may be adjusted to reduce the temperature at the surgical site, thereby preventing laser-induced tissue thermal damage. In some examples, the estimated temperature, optionally along with the information of target identification, may be applied to a trained ML model to automatically determine at least one operating parameter of the endoscopic surgical system, such as a proper laser setting, or an irrigation and / or suction setting to be used during the procedure.

[0124] At step 850, energy (e.g., laser energy) may be provided to the anatomical target at the fluid surgical site via an energy source. In an example, laser energy may be delivered in accordance with a laser output intensity or one or more laser irradiation parameters (e.g., one or more laser pulse parameters such as, power, duration, frequency, or pulse shape, exposure time, or firing angle). At least some of the laser parameters are programmable or adjustable in accordance with the estimated temperature at the surgical site.

[0125] In some examples, the adjustment of at least one operating parameter at step 840 may be further based on identification of an anatomical target as one of a plurality of structure types of the same category, such as a particular tissue type within an identified category of anatomical structure, or as a particular calculi type within an identified category of calculi structure. The target identification may be based on one or more spectroscopic properties or acoustic properties of the anatomical target. In an example, in addition to NIR light emitted from a first light source at step 810, a visible light may be emitted from a second light source to the anatomical target, and a spectroscopic property of the anatomical target may be determined based on the spectra of a portion of the visible light reflected from the anatomical target at 400-700 nm wavelength range, as described above with respect to FIG. 4. Identification of a type or composition of the anatomical target may be performed based at least in part on the determined spectroscopic property of the anatomical target. One or more operating parameter of the endoscopic surgical system, such as laser output intensity or one or more laser irradiation parameters, may be adjusted further based on the identified type or composition of the anatomical target.

[0126] FIG. 9 illustrates generally a block diagram of an example machine 900 upon which any one or more of the techniques (e.g.,methodologies) discussed herein may perform. Portions of this description may apply to the computing framework of various portions of the endoscopic surgical system 200 or the endoscopic laser lithotripsy system 300.

[0127] In alternative embodiments, the machine 900 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 900 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 900 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 900 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0128] Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms. Circuit sets are a collection of circuits implemented in tangible entities that include hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership may be flexible over time and underlying hardware variability. Circuit sets include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the executionunits or a loading mechanism) to create members of the circuit set in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuit set member when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuit set. For example, under operation, execution units may be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.

[0129] Machine (e.g., computer system) 900 may include a hardware processor 902 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 904 and a static memory 906, some or all of which may communicate with each other via an interlink (e.g., bus) 908. The machine 900 may further include a display unit 910 (e.g., a raster display, vector display, holographic display, etc.), an alphanumeric input device 912 (e.g., a keyboard), and a user interface (UI) navigation device 914 (e.g., a mouse). In an example, the display unit 910, input device 912 and UI navigation device 914 may be a touch screen display. The machine 900 may additionally include a storage device (e.g., drive unit) 916, a signal generation device 918 (e.g., a speaker), a network interface device 920, and one or more sensors 921, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensors. The machine 900 may include an output controller 928, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0130] The storage device 916 may include a machine readable medium 922 on which is stored one or more sets of data structures or instructions 924 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 924 may also reside, completely or at least partially, within the main memory 904, within static memory 906, or within the hardware processor 902 during execution thereof by the machine 900. In an example, one or any combination of the hardware processor 902, the mainmemory 904, the static memory 906, or the storage device 916 may constitute machine readable media.

[0131] While the machine-readable medium 922 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 924.

[0132] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 900 and that cause the machine 900 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Nonlimiting machine-readable medium examples may include solid-state memories, and optical and magnetic media. In an example, a massed machine-readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine- readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EPSOM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0133] The instructions 924 may further be transmitted or received over a communication network 926 using a transmission medium via the network interface device 920 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 920may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communication network 926. In an example, the network interface device 920 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 900, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.Additional Notes

[0134] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0135] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includeselements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0136] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is:

1. An endoscopic surgical system, comprising: an endoscopic surgical device configured to operably couple to an energy source for providing energy to an anatomical target at a fluid surgical site during a procedure; a lighting system, including a first light source configured to emit a near infrared (NIR) light at a specific wavelength range to the anatomical target; and a controller circuit configured to: determine fluid NIR light absorption spectra in a vicinity of the anatomical target; estimate fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; and based at least in part on the estimated fluid temperature, adjust at least one operating parameter of the endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure.

2. The endoscopic surgical system of claim 1, wherein the anatomical target includes a calculi target, wherein the endoscopic surgical device is an endoscopic lithotripsy device configured to ablate or fragment the calculi target.

3. The endoscopic surgical system of any of claims 1-2, wherein the first light source is configured to emit the NIR light at a wavelength range of 700- 1000 nanometers.

4. The endoscopic surgical system of any of claims 1-3, wherein to determine the fluid NIR light absorption spectra, the controller circuit is configured to detect an absorption spectral peak over the specific wavelength range, and to determine a spectral property including at least one of: an intensity of the absorption spectral peak; a wavelength corresponding to the absorption spectral peak; or a bandwidth of the absorption spectral peak.

5. The endoscopic surgical system of any of claims 1-4, wherein the controller circuit is configured to determine a change or a rate of change in the estimated fluid temperature in the vicinity of the anatomical target, and to adjust the at least one operating parameter of the endoscopic surgical system based on the determined change or rate of change in the estimated fluid temperature.

6. The endoscopic surgical system of claim 5, wherein the controller circuit is configured to determine an increase or a rate of increase in the estimated fluid temperature in the vicinity of the anatomical target based on at least one of: an increase in absorption spectral peak intensity; a decrease in absorption spectral peak wavelength; or a narrowing of absorption spectral bandwidth.

7. The endoscopic surgical system of any of claims 1-6, wherein the controller circuit is further configured to: generate a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times; and adjust the at least one operating parameter in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

8. The endoscopic surgical system of claim 7, wherein to adjust the at least one operating parameter, the controller circuit is configured to reduce an average power of laser pulses delivered to the surgical site in response to (i) the generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) the prediction of future temperature exceeding a temperature threshold.

9. The endoscopic surgical system of any of claims 1-8, wherein the energy source includes at least one laser source to provide laser pulses,wherein the at least one operating parameter to be adjusted includes a laser output setting of the at least one laser source, wherein the controller circuit is configured to generate a control signal to the at least one laser source to deliver the laser pulses in accordance with the adjusted at least one operating parameter.

10. The endoscopic surgical system of claim 9, wherein to adjust the laser output setting, the controller circuit is configured to, in response to the estimated fluid temperature exceeding a temperature threshold, reduce an average power of the laser pulses delivered to the anatomical target, including reducing at least one of a pulse width, a peak power, or pulse frequency of the laser pulses.

11. The endoscopic surgical system of claim 9, wherein to adjust the laser output setting, the controller circuit is configured to, in response to estimated fluid temperature exceeding a temperature threshold, at least temporarily disable the at least one laser source from delivering the laser pulses to the anatomical target.

12. The endoscopic surgical system of any of claims 1-11, further comprising an irrigation and / or suction system configured to provide irrigant into, and suction of fluid from, the anatomical target during the procedure, wherein to adjust the at least one operating parameter, the controller circuit is configured to increase at least one of an irrigation flow or a suction flow via the irrigation and / or suction system in response to the estimated fluid temperature exceeding a temperature threshold.

13. The endoscopic surgical system of claim 12, further comprising an irrigant treatment unit configured to alter a temperature of the irrigant, wherein the controller circuit is configured to, based at least in part on the estimated fluid temperature, generate a control signal to the irrigant treatment unit to adjust a temperature of the irrigant before reaching the anatomical target.

14. The endoscopic surgical system of any of claims 1-13, wherein the lighting system further includes a second light source configured to emit a visible light to the anatomical target, the visible light having a wavelength range different from the wavelength range of the NIR light, wherein the controller circuit is further configured to: determine a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target; identify a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target; and adjust the at least one operating parameter of the endoscopic surgical system based at least in part on the identified type or composition of the anatomical target.

15. The endoscopic surgical system of claim 14, wherein the second light source is configured to emit the visible light at a wavelength range of 400-700 nanometers.

16. The endoscopic surgical system of claim 14, wherein the controller circuit is configured to, in response to the estimated fluid temperature exceeding a temperature threshold, enable the energy source to: deliver the energy to the anatomical target if the anatomical target is identified as a calculi target; and at least temporarily disable the energy source from delivering the energy to the anatomical target if the anatomical target is identified as an anatomical tissue to protect tissue from injury.

17. The endoscopic surgical system of claim 14, wherein the controller circuit is configured to synchronize emission of the NIR light and the visible light respectively from the first light source and the second light source.

18. A modular endoscopic surgical system, comprising:an endoscopic surgical device configured to operably access an anatomical target at a fluid surgical site during a procedure; and modular devices detachably coupled to, or operatively communicate with, the endoscopic surgical device, the modular devices including: an energy source configured to provide energy to the anatomical target; at first light source configured to emit a near infrared (NIR) light at a specific wavelength range to the anatomical target; a feedback analyzer module configured to determine fluid NIR light absorption spectra in a vicinity of the anatomical target; a temperature monitor module configured to estimate fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; and a controller module configured to, based at least in part on the estimated fluid temperature, adjust at least one operating parameter of the modular endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure.

19. The modular endoscopic surgical system of claim 18, wherein the modular devices further include a second light source configured to emit a visible light to the anatomical target, the visible light having a wavelength range different from the wavelength range of the NIR light, wherein the feedback analyzer module is further configured to determine a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target, and to identify a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target, wherein the controller module is configured to adjust the at least one operating parameter of the modular endoscopic surgical system further based on the identified type or composition of the anatomical target.

20. The modular endoscopic surgical system of any of claims 18-19,wherein the energy source comprises at least one laser source configured to provide laser pulses to the anatomical target, wherein to adjust the at least one operating parameter, the controller module is configured to adjust a laser output setting of the at least one laser source, and to generate a control signal to the at least one laser source to deliver the laser pulses in accordance with the adjusted at least one operating parameter.

21. The modular endoscopic surgical system of claim 20, wherein to adjust the laser output setting, the controller module is configured to, in response to the estimated fluid temperature exceeding a temperature threshold, reduce an average power of the laser pulses delivered to the anatomical target, including reducing at least one of a pulse width, a peak power, or a pulse frequency of the laser pulses.

22. The modular endoscopic surgical system of any of claims 18-21, wherein the temperature monitor module is further configured to generate a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times,Wherein the controller module is configured to adjust the at least one operating parameter further in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

23. The modular endoscopic surgical system of any of claims 18-21, further comprising an irrigation and / or suction system configured to provide irrigant into, and suction of fluid from, the anatomical target during the procedure, wherein the controller module is configured to adjust the at least one operating parameter including at least one of an irrigation flow or a suction flow to be adjusted via the irrigation and / or suction system.

24. A method for monitoring and controlling temperature at a fluid surgical site of a patient during an endoscopic procedure using an endoscopic surgical system, the method comprising:directing a near infrared (NIR) light at a specific wavelength range from a first light source to an anatomical target at a fluid surgical site; determining fluid NIR light absorption spectra in a vicinity of the anatomical target via a feedback analyzer; estimating fluid temperature in the vicinity of the anatomical target using the determined fluid NIR light absorption spectra; based at least in part on the estimated fluid temperature, adjusting at least one operating parameter of the endoscopic surgical system to achieve or maintain substantially a target temperature at the fluid surgical site during the procedure; and providing energy to the anatomical target at the fluid surgical site via an energy source.

25. The method of claim 24, further comprising: directing a visible light from a second light source to the anatomical target, the visible light having a wavelength range different from the wavelength range of the NIR light; determining a spectroscopic property of the anatomical target using at least a portion of the visible light reflected from the anatomical target; and identifying a type or composition of the anatomical target based at least in part on the determined spectroscopic property of the anatomical target; wherein adjusting the at least one operating parameter of the endoscopic surgical system is further based on the identified type or composition of the anatomical target.

26. The method of any of claims 24-25, wherein the energy provided to the anatomical target includes laser pulses generated by at least one laser source, wherein adjusting the at least one operating parameter includes adjusting a laser output setting of the at least one laser source, wherein the laser pulses are delivered to the anatomical target in accordance with the adjusted at least one operating parameter.

27. The method of any of claims 24-26, further comprising generating a temperature trend or a prediction of future temperature at the fluid surgical site based at least in part on a plurality of estimated fluid temperatures at different times, wherein adjusting the at least one operating parameter is further in response to the temperature trend or the prediction of future temperature satisfying respective conditions.

28. The method of any of claims 24-27, wherein adjusting the at least one operating parameter includes, in response to the estimated fluid temperature exceeding a temperature threshold, reducing an average power of laser pulses delivered to the surgical site via at least one laser system, including reducing at least one of a pulse width, a peak power, or a pulse frequency of the laser pulses.

29. The method of any of claims 24-28, wherein adjusting the at least one operating parameter includes, via an irrigation and / or suction system, increasing at least one of an irrigation flow of irrigant into the surgical site or a suction flow of fluid out of the surgical site, in response to the estimated fluid temperature exceeding a temperature threshold.

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