Adjusting surgical device settings based on predicted surgical site conditions

Abstract

To provide modulation of surgical device settings based on forecasted surgical site conditions.SOLUTION: Systems and methods for automatic control of a surgical site temperature during an endoscopic procedure are disclosed. An exemplary endoscopic surgical system comprises an endoscopic surgical device controllably coupled to a medical instrument in order to deliver energy to an anatomical target at a surgical site, a temperature sensor to measure a temperature at the surgical site at different times during the procedure, and a controller circuit to generate a temperature trend or prediction of a future temperature at the surgical site using the temperature measurements. On the basis of at least in part, the generated temperature trend or the prediction of the future temperature at the surgical site, the controller circuit can adjust at least one operating parameter associated with the endoscopic surgical system in order to substantially achieve or maintain a desired temperature at the surgical site during the procedure, or prevent or reduce severity of laser-induced tissue thermal damage.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 369,098, filed July 22, 2022, the contents of which are incorporated herein in their entirety.

[0002] The present invention relates generally to endoscopic surgery systems, and more particularly to techniques for adjusting one or more settings of an endoscopic surgery system based on predicted surgical site conditions. [Background technology]

[0003] Endoscopes are typically used to access internal locations of a patient to provide visual access to the physician. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign bodies from a patient's body. For example, nephroscopes are used by clinicians to examine the renal system and perform various procedures under direct visual control. In a percutaneous nephrolithotomy (PCNL) procedure, a nephroscope is placed into the renal pelvis through the patient's flank. For example, stones or masses from various areas of the body, including the urinary system, gallbladder, nasal cavity, digestive tract, stomach, or tonsils, may be visualized and extracted.

[0004] Various medical devices, such as laser or plasma systems, have been used to deliver surgical laser energy to various target treatment areas, such as soft or hard tissue. Examples of laser treatments include ablation, coagulation, vaporization, fragmentation, etc. In lithotripsy applications, lasers have been used to break up stone structures in the kidney, gallbladder, and ureter, among other stone-forming areas, or to ablate larger stones into smaller fragments. Stone fragments may be removed through the working channel of an endoscope (e.g., ureteroscope) or may be naturally expelled by the patient following the procedure.

[0005] Heat accumulation is a potentially dangerous effect of laser irradiation of anatomical or lithotripsy targets, especially when relatively high intensity laser output is used in treatment, such as laser lithotripsy to ablate or fragment stone targets of specific size, shape, hardness, or composition. Excessive heat accumulation at or near the surgical site can cause thermal damage to non-target tissues or organs. Summary of the Invention [Problem to be solved by the invention]

[0006] Effective surgical site temperature control can help prevent thermal tissue damage caused by heat accumulation during medical procedures, such as laser lithotripsy or ultrasonic lithotripsy procedures. Traditionally, temperature is sensed from the surgical site and displayed to a user (e.g., physician) during the procedure. A user may manually change the settings of the medical device (e.g., laser output intensity) or temporarily turn off the medical device if the surgical site temperature is above a safe limit. Such manual temperature adjustments may not accurately implement surgical site temperature control. Furthermore, adjustments of the medical device settings (e.g., laser output intensity) may not achieve adequate and rapid temperature relief at the surgical site. For example, in some cases, reducing the laser output intensity or shutting off the laser output may reduce treatment efficiency and / or increase treatment time. It should be noted that while medical devices herein refer to laser systems, any suitable medical instrument, such as an ultrasound system, that may be coupled to or implemented in an endoscope to perform targeted treatment or diagnosis, is also within the scope of the present invention. [Means for solving the problem]

[0007] The present invention describes systems, devices, and methods for improving surgical site temperature control by automatically adjusting one or more device settings based on predicted surgical site conditions, such as a temperature trend or a prediction of future temperature at or near the surgical site. According to one embodiment, an exemplary endoscopic surgery system includes an endoscopic surgery device controllably coupled to a medical instrument (e.g., a laser system) and configured to deliver energy (e.g., laser energy) to an anatomical target at the surgical site during a procedure, a temperature sensor configured to measure the temperature at the surgical site at various times during the procedure, and a controller circuit for generating a temperature trend or a prediction of future temperature near the surgical site using the temperature measurements at various times. Based at least in part on the generated temperature trend or prediction of future temperature at the surgical site, the controller circuit may adjust at least one operating parameter associated with the endoscopic surgery system to achieve or maintain substantially a desired temperature at the surgical site during a procedure. As used herein, the term "substantially" means ±10%, and in some embodiments ±5%. The surgical site temperature control techniques described herein may advantageously prevent or reduce the severity of tissue thermal damage caused by excessive energy (e.g., laser energy) delivered to the tissue site. Various temperature control means allow for more versatile control of surgical site temperature according to surgical site conditions. Alternative temperature control means (e.g., irrigation or aspiration of fluids, and irrigation treatments) may help to avoid interruptions or substantial reductions in energy output in endoscopic procedures (e.g., laser or ultrasonic lithotripsy procedures). Thus, accurate and rapid temperature control, as well as improved efficacy of laser therapy and tissue safety, may be achieved.

[0008] Example 1 is an endoscopic surgery system comprising: an endoscopic surgery device controllably coupled to a medical instrument for delivering energy to an anatomical target at a surgical site during a procedure; a temperature sensor for measuring temperature near the surgical site at various times during the procedure; and a controller circuit configured to generate a temperature trend or a prediction of future temperature at the surgical site based at least in part on the temperature measurements at the various times, and to adjust at least one operating parameter associated with the endoscopic surgery system to achieve or maintain a substantially desired temperature at the surgical site during the procedure based at least in part on the generated temperature trend or prediction of future temperature at the surgical site.

[0009] In Example 2, the subject matter of Example 1 optionally includes that the medical device comprises at least one laser system for delivering laser energy to a stone target at the surgical site when the endoscopic surgical system operates according to the adjusted at least one operating parameter.

[0010] In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes that the controller circuit is further configured to use the generated temperature trend to determine a rate of temperature change at the surgical site, and adjust at least one operating parameter in response to the determined rate of temperature change exceeding a predetermined threshold rate of temperature change.

[0011] In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes that the controller circuit is further configured to generate a trained predictive model using the temperature measurements at various times, further use the trained predictive model to generate a prediction of a future temperature at the surgical site, and adjust at least one operating parameter in response to a prediction of the future temperature exceeding a temperature threshold.

[0012] In Example 5, the subject matter of any one or more of Examples 1-4 optionally includes the controller circuit being further configured to estimate a safe operating time window representing an estimate of the time required to reach a safe operating temperature limit at the surgical site using the temperature measurements at various times, and adjust at least one operating parameter in response to the estimated safe operating time window falling below a time threshold.

[0013] In Example 6, the subject matter of Example 2 optionally includes, wherein the at least one operating parameter adjusted includes a laser power setting of the at least one laser system.

[0014] In Example 7, the subject matter of Example 6 optionally includes, to adjust the laser power setting, the controller circuitry is further configured to switch between at least a first predetermined pulse profile and a second predetermined pulse profile based at least in part on a temperature trend or a prediction of future temperature generated at the surgical site, the second predetermined pulse profile having a lower average power than the first predetermined pulse profile.

[0015] In Example 8, the subject matter of any one or more of Examples 6-7 optionally includes, to adjust the laser power setting, the controller circuit is further configured to reduce the average power of the laser pulses delivered to the surgical site in response to (i) a generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) a prediction of a future temperature exceeding a temperature threshold.

[0016] In Example 9, the subject matter of Example 8 optionally includes, wherein reducing the average power of the laser pulse includes reducing at least one of a pulse width of the laser pulse, a peak power of the laser pulse, and a pulse frequency representing the number of laser pulses per unit time.

[0017] In Example 10, the subject matter of any one or more of Examples 1-9 optionally includes an irrigation and / or aspiration system configured to supply irrigation fluid to the surgical site and aspirate fluid from the surgical site.

[0018] In Example 11, the subject matter of Example 10 optionally includes, in order to adjust at least one operating parameter, the controller circuitry is further configured to adjust at least one of irrigation flow or aspiration flow via the irrigation and / or aspiration system based at least in part on the generated temperature trend or prediction of future temperature at the surgical site.

[0019] In Example 12, the subject matter of Example 11 optionally includes, wherein the controller circuit is configured to increase at least one of the irrigation flow or the aspiration flow in response to (i) a generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) a prediction of a future temperature exceeding a temperature threshold.

[0020] In Example 13, the subject matter of any one or more of Examples 11-12 optionally includes a pressure sensor configured to sense pressure at the surgical site during a procedure, and the controller circuitry is further configured to selectively increase irrigation flow or aspiration flow via the irrigation and / or aspiration system, including increasing the aspiration flow or reducing the irrigation flow when the sensed pressure exceeds an upper pressure limit, increasing one or both of the irrigation flow or aspiration flow when the sensed pressure is within a range defined by an upper pressure limit and a lower pressure limit, and increasing the irrigation flow or reducing the aspiration flow when the sensed pressure falls below the lower pressure limit.

[0021] In Example 14, the subject matter of any one or more of Examples 10 to 13 optionally includes an irrigation processing unit configured to alter the temperature of the irrigation fluid, and the controller circuitry is further configured to generate a control signal to the irrigation processing unit to adjust the temperature of the irrigation fluid before it reaches the surgical site based at least in part on the generated temperature trend or prediction of future temperature at the surgical site.

[0022] In Example 15, the subject matter of Example 14 optionally includes that the irrigation processing unit includes a cooling system configured, under control of the controller circuit, to cool the irrigation fluid before it reaches the surgical site in response to (i) a generated temperature trend indicating a rise in temperature at a rate exceeding a rate threshold, or (ii) a predicted future temperature exceeding a temperature threshold.

[0023] In Example 16, the subject matter of any one or more of Examples 14-15 optionally includes that the irrigation processing unit includes a fluid mixer configured, under control of the controller circuit, to mix at least two sources of irrigation fluid of different temperatures before reaching the surgical site in response to (i) a generated temperature trend indicating a temperature increase at a rate exceeding a rate threshold, or (ii) a predicted future temperature exceeding a temperature threshold.

[0024] In Example 17, the subject matter of any one or more of Examples 2 and 6-9 optionally includes, wherein the endoscopic surgical device includes an optical path having an adjustable distal portion, the optical path configured to direct laser energy to an anatomical target, and the controller circuitry is further configured to generate a control signal to an actuator coupled to the optical path to adjust a position or orientation of the distal portion of the optical path relative to the anatomical target based at least in part on the generated temperature trend or prediction of future temperature at the surgical site.

[0025] In Example 18, the subject matter of any one or more of Examples 1 to 17 optionally includes that at least one operating parameter associated with the endoscopic surgical system includes at least one of a temperature of the irrigation fluid before it is applied to the surgical site, an irrigation flow rate, an aspiration flow rate, or a laser output setting of the laser system.

[0026] In Example 19, the subject matter of Example 18 optionally includes, wherein the controller circuitry is further configured to bias and perform an adjustment to one of the operating parameters based at least in part on at least one of the generated temperature trend, a prediction of future temperature, or pressure at the surgical site.

[0027] In Example 20, the subject matter of Example 19 optionally includes, when the controller circuit determines that the pressure at the surgical site has fallen substantially below a maximum allowable pressure, further configured to adjust at least one of the irrigation flow rate or the aspiration flow rate before adjusting the laser output setting.

[0028] In Example 21, the subject matter of any one or more of Examples 19-20 optionally includes, when the controller circuit determines that the pressure at the surgical site is substantially close to a maximum allowable pressure, adjusting the laser output setting before adjusting the irrigation flow rate or the aspiration flow rate.

[0029] In Example 22, the subject matter of any one or more of Examples 1-21 optionally includes a user interface device configured to generate a surgical site temperature rise warning in response to (i) a generated temperature trend indicating a temperature rise at a rate exceeding a rate threshold, or (ii) a prediction of a future temperature exceeding a temperature threshold.

[0030] In Example 23, the subject matter of Example 22 optionally includes, wherein the user interface device is configured to generate recommended adjustments of at least one operating parameter and receive user input for confirming, rejecting, or modifying the recommended adjustments.

[0031] Example 24 is a method for controlling a temperature at a patient's surgical site during an endoscopic procedure using an endoscopic surgery system, the method including the steps of directing energy generated by a medical device to an anatomical target at the surgical site, measuring the temperature near the surgical site at various times during the procedure, generating a temperature trend or a prediction of future temperature at the surgical site based at least in part on the temperature measurements at the various times, and adjusting at least one operating parameter associated with the endoscopic surgery system to achieve or maintain a substantially desired temperature at the surgical site during the procedure based at least in part on the generated temperature trend or prediction of future temperature at the surgical site.

[0032] In Example 25, the subject matter of Example 24 optionally includes a step of determining a rate of temperature change at the surgical site using the generated temperature trend, and the step of adjusting at least one operating parameter is responsive to the determined rate of temperature change exceeding a predetermined threshold value of the rate of temperature change.

[0033] In Example 26, the subject matter of any one or more of Examples 24 to 25 optionally includes a step of generating a trained predictive model using temperature measurements at various times, wherein generating a prediction of a future temperature at the surgical site is done by using the trained predictive model, and wherein adjusting at least one operating parameter is responsive to a prediction of the future temperature exceeding a predetermined temperature threshold.

[0034] In Example 27, the subject matter of any one or more of Examples 24 to 26 optionally includes a step of estimating a safe operating time window using temperature measurements at various times, the safe operating time window representing an estimate of the time required to reach a safe operating temperature limit at the surgical site, and the step of adjusting the operating parameters optionally includes a step of adjusting the operating parameters in response to the estimated safe operating time window falling below a time threshold.

[0035] In Example 28, the subject matter of any one or more of Examples 24-27 optionally includes, wherein adjusting at least one operating parameter includes reducing an average power of laser pulses delivered to the surgical site via at least one laser system in response to (i) a generated temperature trend indicating an increase in temperature at a speed exceeding a speed threshold, or (ii) a prediction of a future temperature exceeding a temperature threshold.

[0036] In Example 29, the subject matter of any one or more of Examples 24-28 optionally includes, wherein adjusting at least one operating parameter includes increasing, via the irrigation and / or aspiration system, at least one of an irrigation flow of irrigation fluid to the surgical site or an aspiration flow of fluid from the surgical site in response to (i) a generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) a prediction of a future temperature exceeding a temperature threshold.

[0037] In Example 30, the subject matter of Example 29 includes a step of sensing pressure at the surgical site during the procedure using a pressure sensor, and the step of adjusting at least one of the irrigation flow or the aspiration flow optionally includes a step of increasing the aspiration flow or decreasing the irrigation flow when the sensed pressure exceeds an upper pressure limit, a step of increasing one or both of the irrigation flow or the aspiration flow when the sensed pressure is within a range defined by an upper pressure limit and a lower pressure limit, and a step of increasing the irrigation flow or decreasing the aspiration flow when the sensed pressure falls below the lower pressure limit.

[0038] In Example 31, the subject matter of any one or more of Examples 24 to 30 optionally includes, wherein adjusting at least one operating parameter includes adjusting a temperature of the irrigation fluid prior to flowing into the surgical site based at least in part on the generated temperature trend or prediction of future temperature at the surgical site via an irrigation processing unit coupled to the irrigation and / or suction system.

[0039] In Example 32, the subject matter of any one or more of Examples 24 to 31 optionally includes, wherein adjusting at least one operating parameter includes adjusting a position or orientation of a distal portion of the optical path relative to an anatomical target at the surgical site, and directing energy to the anatomical target via the optical path.

[0040] In Example 33, the subject matter of any one or more of Examples 24 to 32 optionally includes that at least one operating parameter associated with the endoscopic surgical system includes at least one of a temperature of the irrigation fluid before it is applied to the surgical site, an irrigation flow rate, an aspiration flow rate, or a laser output setting of the laser system.

[0041] In Example 34, the subject matter of any one or more of Examples 24 to 33 optionally includes generating, on a user interface, a warning of an increase in surgical site temperature in response to (i) a generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold or (ii) a prediction of a future temperature exceeding the temperature threshold; generating a recommended adjustment of at least one operating parameter; and receiving user input to confirm, reject, or modify the recommended adjustment.

[0042] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details regarding the present subject matter are found in the detailed description and the appended claims. Other aspects of the present disclosure will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, each of which should not be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents.

[0043] Various embodiments are illustrated by way of example in the accompanying drawing figures. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present subject matter. [Brief description of the drawings]

[0044] [Figure 1] FIG. 1 is a block diagram illustrating an example of a laser energy delivery system configured to perform laser treatment on an anatomical target at or near a surgical site. [Diagram 2] FIG. 1 is a block diagram illustrating an endoscopic surgery system with automatic surgical site state control and at least a portion of the environment in which the system may operate. [Diagram 3] FIG. 1 illustrates an example of an endoscopic laser lithotripsy system with automatic surgical site condition control. [Figure 4] FIG. 1 illustrates an example of a temperature trend and a prediction of future temperatures using the trend. [Diagram 5] 1 is a flow chart illustrating an exemplary method for controlling surgical site temperature during an endoscopic procedure for treating an anatomical target. [Figure 6A] 1 is a flow chart illustrating an example of a method for generating a temperature management plan based on surgical site conditions, such as surgical site temperature, surgical site pressure, etc. [Figure 6B] 13 is a flow chart illustrating an example of generating a temperature management plan having priorities for controlling surgical site temperature. [Figure 7] FIG. 1 is a block diagram illustrating an example machine upon which any one or more of the techniques (e.g., methodologies) described herein may be implemented. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] An endoscopic procedure is a medical procedure in which internal organs are viewed and manipulated and / or energy (e.g., laser or ultrasonic energy) is delivered to a targeted body area to achieve a particular diagnostic or therapeutic effect. For example, laser endoscopes have been used for soft and hard tissue treatment (e.g., damage or destruction of cancer cells), or for lithotripsy applications. During a procedure, a practitioner may insert a scope into a patient's kidney through an incision in the patient's ureter. Through the scope, the practitioner may identify the location of a particular stone in the kidney or upper ureter and break the stone into small fragments by irradiating the stone through the scope with a relatively high-powered infrared laser beam. The laser beam may ablate the stone into small fragments. The stone fragments may then be removed from the kidney. The scope may include an endoscope, a nephroscope, and / or a cystoscope.

[0046] Laser energy delivered to the surgical site environment and laser treatment of anatomical targets (e.g., ablation and fragmentation of stone targets) can cause heat buildup at or near the surgical site, especially when relatively high intensity laser power is used to ablate or fragment stone targets of a particular size, hardness, or composition. To prevent dangerous effects such as thermal damage to tissue, the temperature within the body or at the surgical site can be monitored during the procedure to ensure it is maintained within a safe temperature range. Traditional surgical site temperature control involves monitoring the temperature in real time. If the temperature reading is at or above a safety limit (e.g., a pre-set threshold), the user (e.g., physician) can reduce the laser power intensity or temporarily disable the laser power. Such manual temperature adjustment has several limitations. First, because surgical site temperatures can rise rapidly, especially when high laser power is used during the procedure, reducing or shutting off the laser power when the temperature reading is at or above a safety limit may be too late to prevent laser-induced thermal damage to tissue. Second, the timing of laser power adjustment is important to prevent tissue damage without compromising ablation or fragmentation efficiency. Manual adjustment of laser power not only places a burden on the surgeon, but may lack precision and predictability, especially for inexperienced physicians. Third, reducing or shutting off laser power may not provide adequate and rapid temperature relief at a particular surgical site or tissue anatomy. In some cases, it is not feasible to shut off or significantly reduce laser power without compromising ablation efficiency. For at least the above reasons, the inventors have recognized an unmet need for devices and methods for automatic and effective temperature control to prevent heat accumulation at a surgical site during procedures such as laser lithotripsy or ultrasonic lithotripsy procedures.

[0047] This specification describes systems, devices, and methods for automatically controlling surgical device settings based on predicted conditions, such as predictions of future temperatures at or near a surgical site. According to one embodiment, an exemplary endoscopic surgical system includes an endoscopic surgical device controllably coupled to a medical instrument (e.g., a laser system) and configured to deliver energy (e.g., laser energy) to an anatomical target at the surgical site during a procedure, a temperature sensor that measures temperature near the surgical site at various times during the procedure, and a controller circuit for generating a temperature trend or a prediction of future temperatures at the surgical site using the measured temperatures at various times. Based at least in part on the generated temperature trend or prediction of future temperatures at the surgical site, the controller circuit may adjust at least one operating parameter associated with the endoscopic surgical system to substantially achieve or maintain (e.g., ±10%, or in some embodiments, ±5%) a desired temperature at the surgical site during a procedure. This approach may advantageously prevent or reduce the severity of thermal tissue damage caused by excessive energy (e.g., laser energy) delivered to the tissue site.

[0048] Systems, devices, and methods according to various embodiments described herein improve real-time surgical site temperature control during laser endoscopic procedures. The features described herein may be further used in connection with endoscopy, laser surgery, laser or ultrasonic lithotripsy, irradiation parameter settings, and / or spectroscopy. Example targets and applications may include laser or ultrasonic lithotripsy of kidney stones, and laser dissection or vaporization of soft tissue. In one example of an endoscopic system incorporating the features described herein, the surgical site temperature may be monitored and trended, and future temperatures may be predicted based on the temperature trend. Compared to traditional displays of temperature measurements, prediction of future temperatures may facilitate taking early and effective preventative measures before the temperature rises to dangerous levels, thereby preventing thermal damage to tissue and improving patient safety.

[0049] This specification describes various temperature control means for regulating the surgical site temperature, such as maintaining the temperature below dangerous levels or within a desired safe range. In one example, the laser output intensity or one or more laser delivery parameters (e.g., one or more laser pulse parameters such as power, duration, frequency or pulse shape, exposure time, or delivery angle) may be adjusted. Additionally or alternatively, irrigation inflow to the surgical site and / or outflow (aspiration) from the surgical site may be adjusted to keep the surgical site temperature under control. In some embodiments, irrigation fluid may be treated (e.g., cooled) before flowing into the surgical site to quickly and effectively reduce the temperature of the surgical site. One or more of such temperature control means may be optimized based on the surgical site conditions. For example, based on tissue pressure at or near the surgical site, irrigation or aspiration flow may be adjusted to achieve or maintain a desired environmental pressure at or near the surgical site while providing a temperature control effect. In some examples, multiple temperature control measures (e.g., adjusting laser power or irradiation parameters, adjusting irrigation or aspiration flow, or performing irrigation treatment) may be combined and / or prioritized to establish a tiered temperature control strategy based on surgical site conditions. Compared with conventional approaches that focus on controlling laser power, various temperature control measures and tiered temperature control strategies as described herein advantageously allow for generic control of surgical site temperature according to surgical site conditions. Using alternative temperature control measures and irrigation treatments, such as irrigation or aspiration flow, may help avoid interruptions or substantial reductions in laser energy output during laser lithotripsy procedures, so that the effectiveness of the laser treatment is not significantly compromised. As a result, accurate and fast temperature control, as well as improved laser treatment effectiveness and tissue safety, may be achieved.

[0050] 1 is a block diagram illustrating an example of a laser energy delivery system 100 configured to perform laser treatment on an anatomical target at or near a surgical site 122 within a subject's body, such as an anatomical structure (e.g., soft tissue, hard tissue, or abnormal tissue such as cancerous tissue) or a stone structure (e.g., a kidney or pancreatic bile duct or gallbladder stone). In some examples, the laser energy delivery system 100 may perform precisely controlled therapeutic treatment of tissue or other anatomical structures (e.g., tissue ablation, coagulation, vaporization, etc.), or treatment of a non-anatomical structure (e.g., ablation or fragmentation of a stone structure).

[0051] The laser energy delivery system 100 may 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 illustrates a laser feedback system connected to a first laser system 102 and optionally connected to a second laser system 104 (shown in dotted lines). 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 a power source, a display, a cooling system, and the like. The first laser system 102 may also include a first optical path 108 operatively coupled to the first laser source 106. In one example, the first optical path 108 includes an optical fiber. The first optical path 108 may be configured to transmit a laser beam from the first laser source 106 to a target structure at or near the surgical site 122.

[0052] The feedback control system 101 may receive feedback signals 130 from the target. Various feedback signals may be used to control the laser delivery, laser energy output, and / or other system parameters to improve therapeutic effects and to achieve or maintain desired conditions, such as a desired temperature at or near the surgical site to prevent or reduce the severity of laser-induced thermal tissue damage. In one example, the feedback signal 130 may include a signal indicative of a surgical site condition, such as a temperature or pressure at or near the surgical site during a procedure. In one example, the feedback signal 130 may include an acoustic signal generated by a laser pulse propagating through a medium (e.g., liquid and vapor) and irradiating the target, causing the target to vibrate. In another example, the feedback signal 130 may include a reflected electromagnetic signal (e.g., reflected illumination light emitted from a light source). In yet another example, the feedback signal 130 may include a reflected laser signal. The feedback control system 101 may analyze the feedback signal 130, generate signal characteristics from the feedback signal 130, and control the laser power (e.g., energy intensity or other laser delivery parameters such as power, duration, frequency or pulse shape, exposure time, or delivery angle) or other system parameters according to the signal characteristics. In examples where the feedback signal 130 is indicative of a surgical site condition, such as a temperature during a procedure, the feedback control system 101 may use the feedback signal 130 to generate a temperature trend or a prediction of a future temperature at the surgical site. Based on the temperature trend or prediction of a future temperature, the feedback control system 101 may adjust the laser power 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 a procedure, and to prevent or reduce the severity of laser-induced thermal tissue damage.

[0053] 1, based on analysis of the feedback signal 130, the feedback control system 101 may control the first laser system 102 and / or the second laser system 104 to generate appropriate laser power to achieve a desired therapeutic effect and to achieve or maintain desired conditions, such as a desired temperature at or near the surgical site, to prevent or reduce the severity of laser-induced thermal tissue damage. For example, the feedback control system 101 may monitor characteristics of a target structure during a therapeutic procedure (e.g., ablation of a stone, such as a kidney stone, into small fragments) to determine whether tissue has been adequately ablated prior to another therapeutic procedure (e.g., coagulation of a blood vessel).

[0054] In one example, the first laser source 106 may be configured to provide a first output 110. The first output 110 may span a first wavelength range, such as one that corresponds to a portion of the absorption spectrum of the target structure at the surgical site 122. Because the first output 110 spans a wavelength range that corresponds to the absorption spectrum of tissue, the first output 110 may result in effective ablation and / or carbonation of the target structure.

[0055] In one example, the first output 110 emitted in a first wavelength range may be configured to absorb light with high absorption of the incident first output 110 by tissue (e.g., approximately 250 cm -1 The first laser source 106 may be configured to correspond to a wavelength range of 1900 nm to 3000 nm (e.g., corresponding to high absorption by water) and / or between about 400 nm to 520 nm (e.g., corresponding to high absorption by oxygenated and / or deoxygenated hemoglobin). Clearly, there are two main mechanisms of light interaction with tissue: absorption and scattering. When tissue absorption is high (above 250 cm), the light is scattered. -1 ), the first absorption mechanism dominates and when absorption is low (absorption coefficients above 250 cm -1 For lasers in the wavelength range of 800 nm to 1100 nm, for example, the scattering mechanism dominates.

[0056] A variety of commercially available medical grade laser systems may be suitable for the first laser source 106. For example, a semiconductor laser may be used, such as an InXGa1-XN semiconductor laser providing a first output 110 in a first wavelength range of about 515 nm to about 520 nm or about 370 nm to about 493 nm. Alternatively, an infrared (IR) laser may be used, such as those summarized in Table 1 below.

[0057] [Table 1]

[0058] The optional second laser system 104 may include a second laser source 116 for providing a second output 120 and associated components such as a power supply, a display, a cooling system, etc. The second laser system 104 may be operatively separate from the first laser source 106 or may be operatively coupled to the first laser source 106. In some embodiments, the second laser system 104 may include a second optical path 118 (separate from the first optical path 108) operatively coupled to the second laser source 116 for transmitting the second output 120. Alternatively, the first optical path 108 may be configured to transmit both the first output 110 and the second output 120.

[0059] In certain aspects, the second output 120 may span a second wavelength range that is different from the first wavelength range. Thus, there may be no overlap between the first and second wavelength ranges. Alternatively, the first and second wavelength ranges may at least partially overlap each other. In advantageous aspects of the present disclosure, the second wavelength range may not correspond to a portion of the absorption spectrum of the target structure where the incident radiation is strongly absorbed by tissue that has not previously been ablated or carbonized. In some such aspects, the second output 120 may not advantageously ablate non-carbonized tissue. In another embodiment, the second output 120 may ablate carbonized tissue that has previously been ablated. In further embodiments, the second output 120 may provide an additional therapeutic effect. For example, the second output 120 may be suitable for coagulation of tissue or blood vessels.

[0060] 2 is a block diagram illustrating an endoscopic surgery system 200 with automatic surgical site condition control and at least a portion of the environment in which the system 200 may operate. The system 200 may be an embodiment of the laser energy delivery system 100 or a lithotripsy system that may be used to break up hardened masses such as kidney stones, gastroliths, gallstones, among other stone structures. The system 200 may monitor and control the conditions of the surgical site 122 during laser surgery, such as to maintain the surgical site temperature at a substantially desired level during the procedure to prevent or reduce the severity of laser-induced thermal tissue damage.

[0061] The endoscopic surgery system 200 may include a feedback control system 210, one or more sensors 220, a laser system 230, an irrigation and / or aspiration system 240, and a user interface device 250. The feedback control system 210, which is one embodiment of the feedback control system 101 of the laser energy delivery system 100, may include a feedback analyzer 212 and a controller circuit 218. According to an exemplary embodiment, the feedback control system 210 may include a processor, such as a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or any other equivalent integrated or discrete logic circuit, and any combination of such components for performing one or more of the functions attributed to the feedback control system 210. The feedback analyzer 212 may be communicatively coupled to the one or more sensors 220 to receive feedback signals therefrom and analyze the feedback signals to generate one or more signal characteristics that may be used to control surgical site conditions. In the example shown in FIG. 2, the one or more sensors 220 may include a temperature sensor 222 configured to sense the temperature near the surgical site during the laser procedure. Examples of the temperature sensor 222 may include a thermocouple, a thermistor, a resistance temperature detector, or a semiconductor sensor integrated into an integrated circuit (IC). The temperature sensor 222 may be located at a distal portion of the laser delivery system (e.g., at the distal end of an optical path or laser fiber for directing the laser energy to the surgical site) or at a distal portion of an endoscope to expose the temperature sensor within the environment of the surgical site and directly measure the temperature therein. The one or more sensors 220 may further include a pressure sensor 224 for sensing the surgical site pressure during the procedure.

[0062] The feedback analyzer 212 may include one or more of a temperature trend circuit 214 or a temperature predictor circuit 216. The temperature trend circuit 214 may generate a trend of temperature measurements over time. Based on the temperature trend, the feedback analyzer 212 may determine a temperature rate of change (ΔT / Δt) indicating an amount of change in temperature (ΔT) per unit time (Δt), such as the rate of temperature rise at or near the surgical site.

[0063] In some examples, the temperature sensor 222 may be located at a location away from the surgical site, such as part of the irrigation and / or aspiration system 240, to measure an "off-site" temperature that is not equivalent to, but correlates with, the surgical site temperature. The feedback analyzer 212 may estimate the surgical site temperature using the trained estimation model and the measured off-site temperature. In some examples, the estimation of the surgical site temperature may be further based on other conditions, such as the laser energy output settings (e.g., power, pulse width, pulse frequency) of the laser system 230, and the irrigation inflow and outflow settings of the irrigation and / or aspiration system 240. U.S. Patent Application Serial No. 15 / 686,465, entitled "Automatic Irrigation-Coordinated Lithotripsy," refers to devices and methods for estimating the temperature of a surgical site using a variety of factors, including, for example, the temperature of the irrigation fluid, the amount of irrigation, and the energy applied to the surgical site. The entirety of such references is incorporated herein by reference.

[0064] The temperature predictor circuit 216 may generate a prediction of future temperatures at the surgical site at a specified future time based on the surgical site temperatures measured at various 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 controlling the temperature of the surgical site) remain unchanged. In one example, the temperature predictor circuit 216 may generate a predictive model using multiple temperature measurements and generate a prediction of future temperatures using the predictive model. The predictive model may be generated using techniques such as curve fitting, and surface fitting, time series regression, or machine learning (ML) techniques. The predictive model may be generated by a model training process using a training data set that includes the surgical site temperatures measured at various times and a model type. The training process includes algorithmically adjusting model parameters (e.g., weights assigned to nodes in the input layer, output layer, or any hidden layer of the neural network model) until a convergence criterion or training stopping criterion is met. The predictive model may include a linear model or a nonlinear model, and the surgical site temperature may be modeled to have a linear or nonlinear relationship with time. In one example, as shown in FIG. 2, the temperature predictor circuit 216 may use the temperature trend or temperature change rate generated by the temperature trend circuit 214 to generate a prediction of future surgical site temperatures. FIG. 4 shows an example of a temperature trend 415 and a prediction of future temperatures using that trend. In this example, the temperature trend 415 as generated by the temperature trend circuit 214 is a linear trend generated using a regression analysis of past temperature measurements at various times (represented by data points 410) and a current temperature T(t0) at time t0 (represented by data points 420) as measured using the temperature sensor 222. The linear temperature trend 415 may be characterized by a temperature change rate represented by the slope of the linear trend 415. For example, the temperature trend circuit 214 may analyze a temperature measurement that increased by 3° C. over the previous 6 seconds prior to the current measurement and determine a temperature change rate of +0.5° C. / sec (+0.5° C. / sec, where "+" indicates a temperature increase).Based on the current temperature T(t0) (e.g., 40°C) and the temperature rise rate (e.g., +0.5°C / sec), the temperature predictor circuit 216 predicts a future temperature represented by a data point 430 at a future time t1 (t1=t0+Δt).

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[0065] In some instances, the measured temperature value exceeds a predefined upper "safe operating" temperature limit (i.e., maximum temperature, T max ), the temperature predictor circuit 216 detects that the temperature is below the “safe operating” temperature limit T max As shown in FIG. 4, a safe operating time window may be estimated, which represents the time when

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[0066] The controller circuit 218 may be coupled to the feedback analyzer 212 by a wired or wireless connection. The controller circuit 218 may compare the monitored surgical site temperature to a particular temperature range, such as the upper "safe operating" temperature limit previously described. When the measured surgical site temperature is within the particular 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 aspiration system 240, according to one or more of the temperature trend (or rate of temperature change) generated by the temperature trend circuit 214, or a prediction of future temperature generated by the temperature predictor circuit 216, or an estimated safe operating time window. For example, if the surgical site temperature meets criteria that warrant temperature adjustment (e.g., if the rate of temperature rise (e.g., +0.8°C / sec) exceeds a rate threshold (e.g., +0.5°C / sec), or if a prediction of the future temperature in the next X seconds (e.g., 15 seconds) exceeds a "safe operating" temperature limit, or if an estimated safe operating time window (e.g., 10 seconds until the surgical site temperature rises to the "safe operating" temperature limit) is shorter than a predetermined threshold window length), the controller circuit 218 may automatically adjust, 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 described further below.

[0067] A laser system 230, which is an example of the laser system 102 or laser system 104 shown in FIG. 1, may include a laser source (such as the first laser source 106) and an optical path (such as the first optical path 108) for directing laser energy to a surgical site. The laser source may generate laser energy according to a laser output intensity or one or more laser delivery parameters (e.g., one or more laser pulse parameters such as power, duration, frequency or pulse shape, exposure time, or delivery angle). At least some of the laser parameters are programmable or adjustable, such as automatically by the controller circuit 218, or manually by a user via the user interface device 250. When the measured surgical site temperature is within a certain temperature range (e.g., below a "safe operating" temperature limit), the controller circuit 218 may automatically adjust the laser output settings according to one or more of the temperature trend (or temperature change rate) generated by the temperature trend circuit 214, or a prediction of future temperature or an estimated safe operating time window generated by the temperature predictor circuit 216. For example, when the surgical site temperature meets a temperature adjustment criterion (if the rate of temperature rise exceeds a rate threshold, or if a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or if an estimated safe operating time window is shorter than a predetermined threshold window length), the controller circuit 218 may automatically reduce the average power of the laser pulses delivered to the surgical site, such as by reducing one or more of the pulse width of the laser pulse, the peak power of the laser pulse, or the pulse frequency, which represents the number of laser pulses per unit time. Reducing the average power of the laser pulses can reduce the laser-induced heating effects at or near the surgical site, thereby preventing thermal damage to tissue during the procedure and improving patient safety.

[0068] In addition to or instead of adjusting one or more laser output parameters, the controller circuit 218 may automatically select one of a plurality of predefined laser output settings or pulse profiles having various energy output levels based on one or more of the temperature trend (or temperature change rate) generated by the temperature trend circuit 214 or the future temperature prediction or estimated safe operating time window generated by the temperature predictor circuit 216. In one example, the controller circuit 218 may automatically switch between at least a first "high power" setting and a second "low power" setting with respective predefined parameter values. The "low power" setting is a lower average power than the "high power" setting. When the surgical site temperature meets the temperature adjustment criteria, the laser output setting may be automatically switched to the "low power" setting.

[0069] In some examples, when the measured surgical site temperature is within a particular temperature range (e.g., below a "safe operating" temperature limit), the controller circuit 218 may generate a control signal to an actuator coupled to the optical path (e.g., laser fiber) of the laser system 230 to adjust the position or orientation of a distal portion of the optical path (laser-illuminated portion) relative to an anatomical target at or near the surgical site. Adjusting the position or orientation of the distal portion of the optical path may include adjusting the distance between the distal portion and the anatomical target (the "fiber-to-target" distance), or the aiming angle of the distal portion relative to the anatomical target, according to one or more of the temperature trend (or rate of temperature change) generated by the temperature trend circuit 214, or a prediction or estimated safe operating time window of future temperature generated by the temperature predictor circuit 216. For example, when the surgical site temperature meets a temperature adjustment criterion (e.g., the rate of temperature rise exceeds a rate threshold, or a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or an estimated safe operating time window is shorter than a predetermined threshold window length), the controller circuit 218 can automatically, via the actuator, move a distal portion of the optical path farther from the surgical site (i.e., increase the fiber-to-target distance) and / or rotate the distal portion of the optical path to point the laser away from the surgical site (increase the aim angle). By increasing the fiber-to-target distance and / or increasing the aim angle, the density of laser energy incident on the surgical site and the laser-induced heat delivered to the surgical site can be reduced.

[0070] The irrigation and / or aspiration system 240 may include one or more irrigation and / or aspiration sources that may provide a flow of irrigation fluid (also referred to as irrigation fluid, e.g., saline) to the surgical site via at least one irrigation channel, such as that included in the endoscope during the procedure. The irrigation fluid may facilitate removal of tissue debris, stone fragments, and other undesirable material via the aspiration channel. The irrigation flow may also have a cooling effect on tissue at or near the surgical site, and on the surgical instruments (e.g., endoscopic tissue removal device), aiding in the dissipation of heat generated during ablation of stones. An example of the irrigation and / or aspiration system 240 is described below with reference to FIG. 3.

[0071] When the measured surgical site temperature is within a certain temperature range (e.g., below a "safe operating" temperature limit), the controller circuit 218 may automatically adjust one or more irrigation parameters, such as irrigation flow or aspiration flow, according to one or more of the temperature trend (or rate of temperature change) generated by the temperature trend circuit 214, or a prediction of future temperature or an estimated safe operating time window generated by the temperature predictor circuit 216. For example, when the surgical site temperature meets a temperature adjustment criterion (e.g., the rate of temperature rise exceeds a rate threshold, or a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or an estimated safe operating time window is shorter than a predetermined threshold window length), the controller circuit 218 may automatically increase irrigation flow from the irrigation source to the surgical site to increase convective heat transfer. Additionally or alternatively, the controller circuit 218 may automatically increase aspiration flow (or aspiration pressure) to improve heat dissipation and reduce surgical site temperature.

[0072] Application of irrigation or aspiration flow to control surgical site temperature can fluctuate pressure at or near the surgical site. For example, irrigation flow to the surgical site generally raises the surgical site pressure (positive pressure change), and aspiration pressure (i.e., outflow) generally lowers the surgical site pressure (negative pressure change). Such irrigation and / or aspiration induced positive or negative pressure changes can be harmful to tissues or organs at or near the surgical site if not properly regulated. To keep the pressure of the anatomical environment under control during the procedure and avoid or reduce pressure-related tissue damage, the system 200 can include a pressure sensor 224 that senses the surgical site pressure during the procedure. When the surgical site temperature meets temperature regulation criteria (e.g., the temperature rise rate exceeds a rate threshold, or the predicted future temperature in the next X seconds exceeds a "safe operating" temperature limit, or the estimated safe operating time window is shorter than a predetermined threshold window length), the controller circuit 218 can selectively activate or adjust the irrigation or aspiration flow based on the measured surgical site pressure (P). For example, an increase in irrigation flow to the surgical site may lead to a positive pressure change at or near the surgical site, so that the measured surgical site pressure P may be adjusted to exceed a predetermined or user-specified upper pressure limit P max (P>P max ), the controller circuit 218 may increase aspiration flow to reduce the surgical site temperature and avoid increasing irrigation flow to prevent a further increase in surgical site pressure. For example, irrigation flow may be maintained at its current rate, or set to a reduced rate, or temporarily stopped. Increasing aspiration flow may also serve to reduce the surgical site pressure to a level that is within the desired pressure range. If the measured surgical site pressure exceeds the upper pressure limit P max and the lower limit pressure P min If the pressure is within the desired range between min <P<P max ), the controller circuit 218 may increase either or both of the irrigation and aspiration flows to reduce the surgical site temperature. Since an increase in aspiration flow can lead to a negative pressure change at or near the surgical site, it is desirable to ensure that the measured surgical site pressure does not exceed the lower pressure limit P min If it falls below (P <P min), the controller circuit 218 may increase irrigation flow to the surgical site to reduce surgical site temperature and avoid increasing aspiration flow to prevent further reduction in surgical site pressure. For example, the aspiration flow may be maintained at its current rate, or set to a reduced rate, or temporarily stopped. Increasing irrigation flow may also serve to increase the surgical site pressure to a level within a desired pressure range.

[0073] In some examples, the irrigation and / or aspiration system 240 may include an irrigation processing unit that may adjust the temperature of the irrigation fluid (irrigation liquid) before it is applied to the surgical site. When the measured surgical site temperature is within a certain temperature range (e.g., below a "safe operating" temperature limit), the controller circuit 218 may generate a control signal to the irrigation processing unit to modify the temperature of the irrigation liquid according to one or more of the temperature trend (or rate of temperature change) generated by the temperature trend circuit 214 or the prediction of future temperature or estimated safe operating time window generated by the temperature predictor circuit 216. In one example, the irrigation processing unit may include a cooling system (e.g., a radiator, or an in-line chiller). When the surgical site temperature meets temperature adjustment criteria (e.g., the rate of temperature rise exceeds a rate threshold, or the predicted future temperature in the next X seconds exceeds a "safe operating" temperature limit, or the estimated safe operating time window is shorter than a predetermined threshold window length), the cooling system, under the control of the controller circuit 218, may cool the irrigation liquid before it reaches the surgical site. In another example, the irrigation processing unit includes a fluid mixer. The fluid mixer, under control of the controller circuit 218, may mix at least two sources of irrigation fluid of different temperatures before reaching the surgical site if the rate of temperature rise exceeds a rate threshold, or if a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or if the estimated safe operating time window is shorter than a predetermined threshold window length. Cooled irrigation fluid via the cooling system or mixed irrigation fluid via the fluid mixer, when applied to the surgical site, may improve convective heat transfer therein and effectively and efficiently reduce the surgical site temperature.

[0074] In some examples, the controller circuit 218 may maintain the surgical site temperature substantially at a desired level or range according to a temperature management plan. The temperature management plan may include prioritization of two or more of the above temperature control measures, including, for example, modifying the laser power setting or one or more laser delivery parameters, adjusting the position or orientation of a distal portion of the optical path (e.g., laser fiber), activating or adjusting irrigation flow to the surgical site and / or aspiration flow away from the surgical site, or modifying the temperature of the irrigation fluid before it is applied to the surgical site, among other measures. The temperature management plan may be programmed or modified by a user, such as via the user interface device 250. The order of the temperature control measures may be determined based on availability (e.g., irrigation cooling system), efficiency of temperature control, or potential adverse effects on the surgical site. In one example, the temperature management plan may be programmed with a bias to maintain an optimal or user-selected laser power setting while adjusting other device settings (e.g., position or orientation of a distal portion of the optical path, irrigation and / or aspiration flow, irrigation temperature) appropriate for managing the surgical site temperature. Maintaining the laser power setting may be desirable during the laser lithotripsy procedure to reduce procedure time and ensure efficacy and efficiency of treatment. Furthermore, adjusting the laser power setting (e.g., lowering the average laser power) may have a slower effect on the surgical site temperature. In some instances, the lithotripsy system may be biased to maintain the physician-selected laser peak power setting even when adjusting the laser power setting. Laser pulse energy may be related to pulse width and peak power according to the following equation (1): Pulse Energy = Pulse Width * Peak Power (1)

[0075] Thus, in some examples, the pulse energy may be reduced by decreasing the pulse width without reducing the peak power. Furthermore, the average laser power may be related to the pulse energy and the pulse frequency (i.e., the number of pulses per second) according to the following equation (2): Average Power = Pulse Energy * Pulse Frequency (2)

[0076] Since fluid temperature increases proportionally to the laser average power, by lowering the pulse energy and maintaining the same pulse frequency, the average power delivered by the laser to the anatomical site can be lowered. Combining equations (1) and (2) yields the following equation (3): Average power = pulse width * peak power * pulse frequency (3)

[0077] Equation (3) defines the relationship between three laser variables (pulse width, peak power, pulse frequency). The above laser variables may be adjusted individually or collectively to produce a desired average power (heating capacity) of the laser emission delivered to the anatomical site. For example, in some instances, the average power may be reduced by lowering the pulse frequency and keeping both the peak power and pulse width constant.

[0078] In some examples, to prevent irrigation and / or aspiration induced pressure fluctuations at or near the surgical site, a temperature management plan may be programmed to use irrigation fluid temperature control (e.g., cooling the irrigation fluid before it is applied to the surgical site) before attempting to adjust irrigation or aspiration flow. For example, when the measured surgical site temperature meets a temperature adjustment criterion (e.g., the rate of temperature rise exceeds a rate threshold, or the predicted future temperature in the next X seconds exceeds a "safe operating" temperature limit, or the estimated safe operating time window is shorter than a predefined threshold window length), the controller circuit 218 may first generate a control signal to the irrigation processing unit of the irrigation and / or aspiration system 240 to cool the irrigation fluid before it is applied to the surgical site. The feedback control system 210 may then reevaluate the surgical site temperature to determine whether it still meets the temperature adjustment criterion, and if so, the controller circuit 218 may generate a control signal to the irrigation and / or aspiration system 240 to increase the irrigation and / or aspiration flow to reduce the surgical site temperature. The selection between irrigation and aspiration flows, or the order of their application, may be based on the surgical site pressure, as described above. For example, if the surgical site temperature is the "safe operation" temperature limit Tmax To prevent this, the system will increase the current surgical site pressure P by a predetermined or user-specified upper pressure limit P max The current surgical site pressure P may be compared to P max Substantially less than (e.g., P and P max If the difference between the current surgical site pressure P and P exceeds a threshold, the irrigation inflow rate may be increased to increase convective heat transfer via irrigation. Additionally or alternatively, the aspiration flow may be increased to efficiently remove heat from the surgical site. In contrast, if the current surgical site pressure P is greater than P max If the current surgical site pressure P is substantially close to (e.g., within a user-specified or predetermined margin, e.g., +10%), the laser power setting may be decreased rather than increasing the irrigation inflow rate. In embodiments where the aspiration flow is actively controlled (e.g., via a pump), the current surgical site pressure P may be increased by 100% relative to the aspiration flow rate. max If the pressure at the surgical site is substantially close to 0.05, the aspiration flow rate may be increased instead of, or in addition to, lowering the laser power setting to reduce the surgical site pressure. Although body tissues can generally accommodate some positive pressure changes, many organs are relatively defenseless against negative pressure changes. Thus, in some instances, one may attempt to increase the irrigation flow before activating or increasing the aspiration flow.

[0079] The feedback control system 210 then re-evaluates the surgical site temperature to determine whether it still meets the temperature adjustment criteria, and if so, the controller circuit 218 may generate a control signal to the laser system 230 to adjust the position or orientation of a distal portion of the optical path or to modify the laser power setting or one or more laser delivery parameters. The tiered sequential actuation or adjustment of various temperature control means may help achieve or maintain desired surgical site conditions (e.g., temperature, pressure) during a procedure without compromising the effectiveness and efficiency of treatment or imposing additional risk of tissue damage at or near the surgical site.

[0080] The user interface device 250 may be in operative communication with the feedback control system. The user interface device 250 may include an output / display unit 252 for displaying information including, for example, surgical site conditions such as temperature, pressure, or other information sensed by the sensor 220, feedback signals generated by the feedback analyzer 212 including temperature trends, predictions of future temperatures, or safe operating time windows (the time it takes for the temperature to be at or above the "safe operating" temperature limit), or current device settings such as laser power settings or irrigation or aspiration flow rates. The output / display unit 252 may display UI elements including visual elements, warnings, haptic feedback, or any combination thereof. The output / display unit 252 may generate warnings regarding potentially dangerous conditions at or near the surgical site, such as an increase in temperature that meets temperature regulation criteria that warrants preventative temperature regulation, or an increase in surgical site pressure. The warnings may be presented in an audible, visual, tactile, or human perceptible form. In one example, the output / display unit 252 may display a countdown timer, progress bar, or other UI element to graphically and / or textually represent the safe operating time window and a “safe operating” temperature limit T max The user may be encouraged to adjust one or more system parameters (e.g., reduce laser power or increase irrigation and / or suction) to extend the time before the surgical site temperature reaches the “safe operating” temperature limit T at 30 seconds. max If the temperature predictor circuit 216 predicts that T will be reached, the output / display unit 252 may display a countdown timer and / or instruct the laser setting to be lowered or max The user may be prompted to take other temperature control measures, such as those described above, to extend the time it takes for the temperature to reach .

[0081] The user interface device 250 may include one or more input units 254 for receiving user programming of the device, such as parameter values ​​defining temperature adjustment criteria (temperature rise rate threshold, "safe operating" temperature limit, or threshold window length of a safe operating time window), and user inputs for adjusting laser power settings, irrigation or aspiration flow parameters, among other device parameters for controlling surgical site temperature. In some examples, the user may provide, via the one or more input units 254, a temperature management plan that specifies the priority of two or more of the above temperature control measures. For example, the user may direct the controller circuit 218 to first reduce the irrigation fluid temperature (if available) without adjusting the laser power of the irrigation flow rate. Then, the user may select a temperature threshold (T th ), the irrigation and / or aspiration flow rates may be increased and / or the laser power may be reduced. th Both and Δt may be defined by a user via one or more input units 254. In one example, as shown in FIG. th is T max and Δt is the safe operating time window.

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[0082] In some examples, the output / display unit 252 may generate recommendations to take preventative measures to prevent tissue damage, such as recommended adjustments to laser power or other system parameters. A user may provide input via one or more input units 254 to confirm, reject, or modify the recommended adjustments.

[0083] FIG. 3 illustrates an example of an endoscopic laser lithotripsy system 300 with automatic surgical site state control, which may be an example of an endoscopic surgery 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, and an irrigation processing unit 342. The endoscope 301 has a proximal portion and an elongated 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 visualization or destruction or treatment of kidney stones or other stones or other targets. As shown in FIG. 3, the endoscope 301 may include or provide visualization and illumination optics, such as a visualization optical path 360 and an illumination optical path 350, each of which may extend longitudinally along the elongated body of the endoscope 301. An eyepiece or camera or imaging display may be provided in or coupled to the visualization optical path 360 to allow user or machine visualization of a target area at or near the distal end of the endoscope 301. The target area may be illuminated by light 370, such as provided by an illumination light source 324 at the proximal end of the illumination optical path 350 and emitted from the distal end of the illumination optical path 350. The light source 324 may include, for example, a xenon lamp, a light emitting diode (LED), a laser diode (LD), or any combination thereof. In one example, the light source 324 may include two or more light sources that emit light with various illumination characteristics, referred to as illumination modes. In one 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 autofluorescence imaging mode, or an infrared imaging mode. The special light illumination may, for example, concentrate and intensify light of a particular wavelength to provide better visualization of tissue or other structures at the surgical site.

[0084] The lithotripsy system 300 may include or be coupled to at least one laser source 332, which may be the first laser source 106, the second laser source 116, or an example of a laser source included in the laser system 230. The laser source 332 may be mechanically and optically connected to an optical path 334, which may include a single optical fiber or a bundle of optical fibers. The optical path 334, which is an embodiment of the first optical path 108 or the second optical path 118, or an optical path included in the laser system 230, may be introduced through a proximal access port to extend into a working channel or other longitudinal passage or lumen of the endoscope 301 or similar instrument.

[0085] The lithotripsy system 300 may include one or more sensors for sensing information from an anatomical target or surgical site, such as a temperature sensor 222 and a pressure sensor 224. As described above with reference to FIG. 2, the temperature sensor 222 may sense the surgical site temperature and the pressure sensor 224 may sense the surgical site pressure during a procedure. The temperature sensor 222 and the pressure sensor 224 may be disposed at the distal end 336 of the optical path 334. Alternatively, the temperature sensor 222 and the pressure sensor 224 may be disposed elsewhere, such as at the distal end 346 of the irrigation and / or aspiration channel 344. In some examples, the temperature sensor 222 and the pressure sensor 224 may be associated with various device components. For example, the temperature sensor 222 may be disposed at the distal end 336 of the optical path 334 and the pressure sensor 224 may be disposed at the distal end of the irrigation and / or aspiration channel 344, or vice versa.

[0086] The irrigation and / or aspiration system 340 (one embodiment of the irrigation and / or aspiration system 240) can include an irrigation source and an aspiration source, each of which is fluidly coupled to a working channel of the endoscope 301, such as an irrigation and / or aspiration channel 344. The irrigation and / or aspiration channel 344 may be a common unified channel for providing irrigation inflow and aspiration outflow at various times. Alternatively, in some examples, the irrigation and / or aspiration channel 344 may comprise two separate channels, such as an irrigation channel and an aspiration channel. The separate irrigation and aspiration channels may be parallel to one another or may be coaxially arranged on a common axis, such as in a nested configuration. The irrigation source may function to supply irrigation fluid (irrigation liquid) to the irrigation and / or aspiration channel 344. The irrigation fluid may be gravity fed or pressurized. In one example, a pump may generate a pressurized irrigation flow through the irrigation and / or aspiration channel 344 to the surgical site. The suction source may function to draw, aspirate, pull, suck, or otherwise move or remove fluids and undesirable materials from the surgical site into a receptacle. The suction source may perform the above functions by generating and applying a vacuum, suction, or negative pressure to the irrigation and / or aspiration channel 344.

[0087] The feedback control system 310 may receive feedback information generated by one or more sensors including, for example, surgical site temperature measurements generated by the temperature sensor 222 and surgical site pressure measurements generated by the pressure sensor 224. The feedback control system may include a feedback analyzer 312 and a controller circuit 318. The feedback analyzer 312 (one embodiment of the feedback analyzer 212) may analyze the temperature measurements generated by the temperature sensor 222 and generate one or more temperature metrics, such as a rate of temperature rise, a prediction of future temperature in the next X seconds, or an estimated safe operating time window. Controller circuit 318 (one embodiment of controller circuit 218) may determine whether the monitored surgical site temperature is within a particular temperature range (e.g., below an upper "safe operating" temperature limit) and whether the temperature rise at or near the surgical site meets temperature adjustment criteria indicating that temperature adjustment is warranted to prevent thermal tissue damage (e.g., if the rate of temperature rise exceeds a rate threshold, or a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or an estimated safe operating time window is less than a predetermined threshold window length), as described above with reference to FIG. 2. If the temperature adjustment criteria are met, controller circuit 318 may automatically adjust, or prompt the user to manually adjust, one or more system parameters to adjust the surgical site temperature to prevent or reduce the severity of laser-induced thermal tissue damage.

[0088] Various temperature control means may be used to regulate the surgical site temperature during a procedure. In one example, the controller circuit 318 may generate a control signal to the laser source 332 to automatically adjust a laser power setting, such as the average power of the laser pulse delivered to the surgical site, such as by lowering one or more of the pulse width of the laser pulse, the peak power of the laser pulse, or the pulse frequency, which represents the number of laser pulses per unit time. In another example, the controller circuit 318 may generate a control signal to an actuator 338 to adjust the position of the laser emitting end relative to a target at the surgical site. The actuator 338 may be coupled to a portion of the optical path 334 and in electrical communication with the controller circuit 318. In one 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 that actuates or enables longitudinal or rotational positioning of the distal end 336 of the optical path 334 relative to the working channel or other longitudinal passage of the endoscope 301, or relative to another reference position for which the endoscope 301 may serve as a reference frame. In response to control signals from the controller circuit 318, the actuator 338 may adjust the position or orientation of the distal end 336 of the optical path 334, such as adjusting the longitudinal position by moving the distal end 336 away from the surgical site (to increase the fiber-to-target distance) and / or adjusting the rotational position by steering the distal end 336 away from the surgical site (to increase the aiming angle).

[0089] In yet another example, the controller circuit 318 may generate control signals to the irrigation and / or aspiration system 340 to automatically adjust one or more irrigation parameters, such as irrigation flow or aspiration flow. The irrigation or aspiration flow may aid in the dissipation of heat generated during a procedure (e.g., laser treatment of tissue or stone fragmentation). The irrigation or aspiration flow may also aid in the removal of fluids and undesirable material (e.g., tissue debris or stone fragments) and may maintain pressure at the surgical site under control, such as maintaining pressure substantially at a user-specified pressure level (e.g., a user-specified pressure with a tolerance such as ±5%-10%). When the monitored surgical site temperature is within a particular temperature range (e.g., below an upper "safe operating" temperature limit) and meets temperature adjustment criteria, the controller circuit 318 may control the irrigation and / or aspiration system 340 to automatically increase irrigation flow to the surgical site to increase convective heat transfer and / or increase aspiration flow (or aspiration pressure) to draw fluid from the surgical site to improve heat dissipation and reduce the surgical site temperature. In some examples, irrigation or aspiration flow may be selectively activated or adjusted based on the surgical site pressure monitored via pressure sensor 224, as described above with reference to FIG. 2.

[0090] In another example, the controller circuit 318 may generate a control signal to the irrigation processing unit 342 to automatically adjust the temperature of the irrigation fluid before it is applied to the surgical site. The irrigation processing unit 342 may include a cooling system (e.g., a radiator, or an in-line chiller) for cooling the irrigation fluid, or a fluid mixer for mixing at least two irrigation fluids of different temperatures. When the monitored surgical site temperature is within a certain temperature range (e.g., below an upper "safe operating" temperature limit) and meets the temperature adjustment criteria, the controller circuit 318 may control the irrigation and / or aspiration system 340 to automatically cool the irrigation fluid via the cooling system or fluid mixer. The irrigation / aspiration system 340 may then apply the cooled irrigation fluid to the surgical site via the irrigation and / or aspiration channels 344 to improve convective heat transfer therein and effectively and efficiently reduce the temperature of the surgical site.

[0091] The controller circuit 318 may generate or receive from a user a temperature management plan that specifies the priority of two or more of the above temperature control measures including, for example, among other means, altering the laser power setting or one or more laser delivery parameters, adjusting the position or orientation of a distal portion of the optical path (e.g., the laser fiber), activating or adjusting irrigation flow to and / or aspiration flow away from the surgical site, or altering the temperature of irrigation fluid before it is applied to the surgical site.

[0092] In some examples, the lithotripsy system 300 may include a camera or imaging device 325 for collecting imaging signals reflected from a target in response to the electromagnetic radiation (e.g., illumination light 370) of a target at or near the surgical site. The imaging signals may be transmitted to the feedback analyzer 312 via optical path 360. Alternatively, the imaging signals reflected from the target or surgical site may be transmitted through optical path 334. An optical splitter may direct the reflected imaging signals to the feedback analyzer 312. The feedback analyzer 312 may include a spectrometer that may generate one or more spectral characteristics from the imaging data. The feedback analyzer 312 may recognize the target as a stone target or an anatomical target at or near the surgical site, or may classify the target as a type of tissue or a type of stone of a different composition using the one or more spectral characteristics. In some examples, the feedback analyzer 312 may calculate or estimate the fiber-to-target distance using the spectral characteristics. The controller circuit 318 may generate control signals to the laser source 332 to adjust laser power settings, to the actuator 338 to adjust the position or orientation (e.g., inter-fibrous distance, or aiming angle) of the distal end 346 of the irrigation and / or aspiration channel 344, and / or to the irrigation and / or aspiration system 340 to adjust irrigation or aspiration flow based on the structure, composition, or type of target.

[0093] 5 is a flow chart illustrating a method 500 for controlling surgical site conditions (such as surgical site temperature) during an endoscopic procedure for treating an anatomical target (e.g., soft tissue, hard tissue, cancerous tissue, or stone structures such as kidney or pancreatic biliary duct or gallbladder stones). Method 500 may be implemented in or performed by endoscopic surgery system 200 or endoscopic laser lithotripsy system 300. Although the processes of method 500 are depicted in a single flow chart, they need not be performed in a particular order. In various examples, some of the processes may be performed in a different order than that shown herein.

[0094] At 510, laser energy (e.g., a laser beam or a series of laser pulses) is delivered to the anatomical target. The laser energy may be generated by a laser source (such as the first laser source 106, the second laser source 116, or the laser source 332) and transmitted through an optical path (such as the first optical path 108, the second optical path 118, or the optical path 334). At 520, the temperature at the surgical site may be sensed at various times during the procedure, such as using the temperature sensor 222. At 530, the surgical site temperature measurements may be trended over time to generate a temperature trend, such as using the temperature trending circuit 214. Additionally or alternatively, a rate of temperature change may be determined using the surgical site temperature measurements. The rate of temperature change (ΔT / Δt) indicates the amount of change in temperature (ΔT) in a unit of time (Δt), such as, for example, the rate of temperature rise at or near the surgical site. In some examples, a prediction of future surgical site temperature at a specified future time (e.g., 5 seconds from the current temperature measurement) may be generated based on surgical site temperature measurements at various past times prior to the current measurement, such as using the temperature predictor circuit 216. The prediction may be made 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 some examples, a predictive model may be generated based on past temperature measurements at various times. For example, various models may be used, including curve fitting, and surface fitting, time series regression, or machine learning (ML) techniques. The predictive model may be trained using a training data set that includes the surgical site temperatures measured at various times and the model type. The training process includes algorithmically adjusting model parameters (e.g., weights assigned to nodes in the input layer, output layer, or any hidden layer of the neural network model) until a convergence criterion or training stopping criterion is met. The trained predictive model may be used to generate a prediction of future surgical site temperature at a specified future time.In some examples, when the measured temperature falls below a predetermined upper "safe operating" temperature limit (maximum temperature), a safe operating time window may be estimated at 530. The safe operating time window represents the time it takes for the temperature to rise above the "safe operating" temperature limit.

[0095] At 540, at least one operating parameter associated with the endoscopic surgery system may be adjusted based at least in part on the generated temperature trend or prediction of future temperature at the surgical site, such as using the controller circuit 218 or the controller circuit 318. By adjusting the at least one operating parameter, a desired temperature at the surgical site may be reached or maintained during the procedure, and potential thermal tissue damage due to excessive heat induced by the laser at the surgical site may be avoided. The adjustment of the at least one operating parameter may be performed automatically, for example, by the controller circuit 218 or the controller circuit 318, which is electrically coupled to various devices of the endoscopic surgery system. Alternatively, information regarding the temperature trend, prediction of future temperature, or safe operating time window may be presented to a user, such as via the user interface device 250. The user may be alerted to an increase in temperature at the surgical site and encouraged to take appropriate precautions, such as adjusting the laser power or other system parameters, well before the temperature reaches a "safe operating" temperature limit.

[0096] For example, as described above with reference to Figures 2 and 3, various temperature control measures may be attempted, including, among other measures, modifying the laser power setting or one or more laser delivery parameters, adjusting the position or orientation of a distal portion of the optical path (e.g., laser fiber), activating or adjusting irrigation flow to the surgical site and / or aspiration flow away from the surgical site, or modifying the temperature of irrigation fluid before it is applied to the surgical site. In some examples, the surgical site temperature may be controlled according to a temperature management plan. Figure 6A is a flow chart illustrating an example of a method for generating such a temperature management plan based on surgical site conditions, including, for example, surgical site temperature and surgical site pressure. The temperature management plan may include a priority order for two or more temperature control measures, as described above. At 601, a temperature trend, or a prediction of future surgical site temperature, as obtained from step 530 of method 500, may be compared to a temperature adjustment criteria. Temperature adjustment criteria may include, for example, (i) the measured surgical site temperature is within a particular temperature range (e.g., below a "safe operating" temperature limit) and (ii) at least one of the following: the rate of temperature rise exceeds a rate threshold, a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or an estimated safe operating time window is shorter than a predetermined threshold window length. At 602, pressure may be sensed at the surgical site, such as using pressure sensor 224. At 603, the sensed surgical site pressure P is measured against a predetermined or user-specified upper pressure limit P, also referred to as the maximum allowable pressure. maxAt 604, a temperature management plan may be determined based on the temperature check at 601 and the pressure check at 603. The availability and efficiency of temperature control means (e.g., irrigation cooling system) or potential adverse effects on the surgical site may also be considered to determine an individualized temperature management plan for the patient. The temperature management plan may include, for example, prioritization of two or more of the temperature control means described above, including, among other means, modifying the laser power setting or one or more laser delivery parameters, adjusting the position or orientation of a distal portion of the optical path (e.g., laser fiber), activating or adjusting irrigation flow to the surgical site and / or aspiration flow away from the surgical site, or modifying the temperature of the irrigation fluid before it is applied to the surgical site. In the example shown in FIG. 6A, when the temperature trend or prediction of future surgical site temperature meets the temperature adjustment criteria at 601, the priority between adjusting the laser power setting and adjusting the irrigation or aspiration flow is determined at 605 based on the surgical site pressure P being above the upper pressure P max The surgical site pressure P may be based at least in part on whether the surgical site pressure P reaches a level substantially close to P max (e.g., P and P max If the difference between P and P exceeds a threshold, the irrigation flow rate may be increased at 606. max is substantially close to (e.g., user-specified or P max Within a predetermined margin of, e.g., +10%), the priority of the temperature control measures may be determined based on whether the option to increase aspiration flow is available at 607. If aspiration flow is not available or is not activated by the user, the laser power setting may be adjusted at 608, such as by lowering the laser power. However, if aspiration flow is available and activated by the user at 607, the aspiration flow rate may be increased at 609. Following temperature control operation at any of steps 606, 608 and 609, other temperature control measures may be attempted in an on-demand mode (e.g., activated by the user). Monitoring of the surgical site temperature may continue at 520.

[0097] 6B is a flow chart illustrating an example of a temperature management plan having an override for controlling surgical site temperature, which may be one embodiment of step 540 of adjusting at least one operating parameter associated with an endoscopic surgical system to achieve or maintain a substantially desired temperature at the surgical site. The temperature trend, prediction of future surgical site temperature, or estimated safe operating time window generated at 530 may be used to determine whether temperature adjustment criteria are met at 610. Such temperature adjustment criteria may include, for example, (i) the measured surgical site temperature is within a particular temperature range (e.g., below a "safe operating" temperature limit) and (ii) at least one of the following: the rate of temperature rise exceeds a rate threshold, a prediction of future temperature in the next X seconds exceeds a "safe operating" temperature limit, or the estimated safe operating time window is less than a predetermined threshold window length. If the criteria are not met at 610, the surgical site temperature is considered normal, the parameters are not adjusted, and monitoring of the surgical site temperature may continue at 620. If the criteria are met at 610, an option is provided at 620 to cool the irrigation fluid before it enters the surgical site. If the irrigation fluid cooling option is available and selected (e.g., by a user), at 622 the irrigation fluid may be cooled before it reaches the surgical site, such as by using a cooling system (e.g., a radiator or in-line chiller included in the irrigation processing unit 342) or by mixing at least two sources of irrigation fluid at different temperatures. The cooled irrigation fluid may be applied to the surgical site to improve convective heat transfer therein. Monitoring of the surgical site temperature may continue at 520.

[0098] If the irrigation fluid cooling option is unavailable or not selected at 620, then an option is provided at 630 to use an irrigation and / or aspiration system (such as irrigation and / or aspiration system 240 or irrigation and / or aspiration system 340). As described above with reference to Figures 2 and 3, the irrigation and / or aspiration system may provide irrigation inflow to the surgical site and / or aspiration flow (outflow) of fluid from the surgical site. In addition to aiding in the removal of tissue debris, stone fragments, and other undesirable material during the procedure, the irrigation and aspiration flows also have a cooling effect on tissue at or near the surgical site. If the irrigation and / or aspiration option is unavailable or not selected (e.g., by a user) at 630, then the laser power settings may be adjusted at 632. For example, the average power of the laser pulse may be reduced, such as by reducing one or more of the pulse width of the laser pulse, the peak power of the laser pulse, or the pulse frequency, which represents the number of laser pulses per unit time. Reducing the average power of the laser pulses can reduce the laser-induced heating effects at or near the surgical site, thereby preventing thermal damage to tissue during the procedure and improving patient safety. In some examples, the position or orientation of a distal portion of the optical path relative to an anatomical target at the surgical site may be adjusted, such as via actuator 338 to adjust the position or orientation of distal end 336 of optical path 334. The position or orientation may be adjusted to increase the fiber-to-target distance and / or to increase the aiming angle, thereby reducing the density of laser energy incident on the surgical site and the laser-induced heat delivered to the surgical site. Monitoring of the surgical site temperature may continue at 520.

[0099] At 630, irrigation and / or aspiration options are available and, if selected, at 640, pressure at the surgical site may be sensed, such as using pressure sensor 224. Depending on the sensed pressure (P) at the surgical site, one or both of the irrigation or aspiration flows may be selectively activated or adjusted to achieve temperature control at the surgical site temperature. At 650, the measured surgical site pressure is adjusted to a predetermined or user-specified upper pressure limit P max The measured surgical site pressure P is compared to P max If it exceeds (P>P max ), at 652, only the aspiration flow rate (and not the irrigation flow rate) is increased to reduce the surgical site temperature. Additionally or alternatively, the irrigation flow rate may be reduced to reduce the pressure at the surgical site. Since an increase in irrigation flow to the surgical site may lead to a positive pressure change at or near the surgical site, further increases in irrigation flow should be avoided to prevent further increases in surgical site pressure. If the measured surgical site pressure is greater than P max If so, then at 660 the measured surgical site pressure is below a predetermined or user-specified lower pressure limit P min The measured surgical site pressure can be further compared to P min and P max If it is within the range defined by (P min <P<P max ), at 670, one or both of the irrigation flow rate or aspiration flow rate may be increased to reduce the surgical site temperature. However, if the measured surgical site pressure at 660 is below the lower pressure limit P min If it is less than (P <P min), at 662, only the irrigation flow into the surgical site (not the aspiration flow) is increased to reduce the surgical site temperature, but increasing the aspiration flow is avoided to prevent further reduction in surgical site pressure. Additionally or alternatively, the aspiration flow may be reduced to increase the pressure at the surgical site. Further increases in aspiration flow should be avoided to prevent further reduction in surgical site pressure, since increasing the aspiration flow may lead to negative pressure changes at or near the surgical site. After adjusting the irrigation or aspiration flow at 652, 662 or 670, monitoring of the surgical site temperature may continue at 620.

[0100] 7 generally illustrates a block diagram of an example machine 700 upon which any one or more of the techniques (e.g., methodologies) described herein may be implemented. Portions of this description may apply to the computing framework of various portions of endoscopic surgery system 200 or endoscopic surgery system 300.

[0101] In alternative embodiments, the machine 700 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked arrangement, the machine 700 may operate in the capacity of a server machine, a client machine, or both in a server-client network environment. In one example, the machine 700 may operate as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. The machine 700 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a web appliance, a network router, a switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify operations to be performed by the machine. Furthermore, although only a single machine is shown, the term "machine" should also be construed to include any collection of machines that individually or jointly execute a set (or sets) of instructions to perform any one or more of the methods described herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations, etc.

[0102] Examples may include or operate by logic or some components, or mechanisms, as described herein. A circuit set is a collection of circuits implemented in a tangible entity that includes hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership is flexible over time and may vary with the underlying hardware. A circuit set includes members that, alone or in combination, may perform a specified operation when in operation. In one example, the hardware of a circuit set may be invariably designed to perform a specific operation (e.g., wiring). In one example, the hardware of a circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) that include computer-readable media (e.g., magnetic, electrical, movable arrangements of immutable mass particles, etc.) that are physically modified to encode instructions for a specific operation. In connecting the physical components, the underlying electrical properties of the hardware components are changed, for example, from insulators to conductors or vice versa. The instructions enable the embedded hardware (e.g., execution units or load mechanisms) to create the members of the circuit set in the hardware through the variable connections to perform some of the specific operations during operation. Thus, the computer-readable medium is communicatively coupled to other components of the circuit set members when the device is operating. In one example, any of the physical components may be used in more than one member of more than one circuit set. For example, during operation, an execution unit may be used in a first circuit of a first circuit set at any one time and reused by a second circuit in the first circuit set or by a third circuit in the second circuit set at various times.

[0103] The machine (e.g., a computer system) 700 may include a hardware processor 702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 704, and a static memory 706, some or all of which may communicate with each other via an interlink (e.g., a bus) 708. The machine 700 may further include a display unit 710 (e.g., a raster display, a vector display, a holographic display, etc.), an alphanumeric input device 712 (e.g., a keyboard), and a user interface (UI) navigation device 714 (e.g., a mouse). In one example, the display unit 710, the input device 712, and the UI navigation device 714 may be touch screen displays. The machine 700 may further include a storage device (e.g., a drive unit) 716, a signal generating device 718 (e.g., a speaker), a network interface device 720, and one or more sensors 721, such as a Global Positioning System (GPS) sensor, a compass, an accelerometer, or other sensor. The machine 700 may include an output controller 728, such as a serial connection (e.g., Universal Serial Bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.), to communicate with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).

[0104] The storage device 716 may include a machine-readable medium 722 that stores one or more sets of data structures or instructions 724 (e.g., software) embodied or utilized by any one or more of the techniques or functions described herein. The instructions 724 may also reside, completely or at least partially, within the main memory 704, within the static memory 706, or within the hardware processor 702 during its execution by the machine 700. In one example, one or any combination of the hardware processor 702, the main memory 704, the static memory 706, or the storage device 716 may constitute a machine-readable medium.

[0105] Although the machine-readable medium 722 is shown 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 one or more instructions 724.

[0106] The term "machine-readable medium" may include any medium capable of storing, encoding, or carrying instructions for execution by the machine 700, causing the machine 700 to perform any one or more of the techniques of this disclosure, or capable of storing, encoding, or carrying data structures used by or related to such instructions. Non-limiting examples of machine-readable media may include solid-state memory, as well as optical and magnetic media. In one example, a large-scale machine-readable medium includes a machine-readable medium having a plurality of particles having an unchanging (e.g., stationary) mass. Thus, the large-scale machine-readable medium is not a transitory propagating signal. Specific examples of large-scale machine-readable media may include non-volatile memories 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, removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks.

[0107] The instructions 724 may further be transmitted or received over a communications network 726 using a transmission medium via a network interface device 720 utilizing any of a number of transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Exemplary communications networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile telephone networks (e.g., cellular networks), plain old telephone (POTS) networks, and wireless data networks (e.g., the Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, the IEEE 802.16 family of standards known as WiMax®, etc.), the IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In one example, the network interface device 720 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to the communications network 726. In one example, the network interface device 720 may include multiple antennas for wireless communication 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" should be interpreted to include any intangible medium capable of storing, encoding, or carrying instructions for execution by the machine 700 and including digital or analog communication signals or other intangible media for facilitating communication of such software.

[0108] Additional Notes The above detailed description includes reference 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 may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples that use any combination or permutation of the elements shown or described (or one or more aspects thereof) with respect to the particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0109] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, regardless of any other instance or use of "at least one" or "one or more." In this document, the term "or" is used to refer to non-exclusive or, unless otherwise specified, "A or B" includes "A but not B," "B but not A," and "A and B." 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, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to those recited after such terms in a claim is still considered to be 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.

[0110] The above description is illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Upon reviewing the above description, other embodiments may be used by those of ordinary skill in the art, etc. The Abstract is provided to comply with 37 CFR §1.72(b) to enable 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 construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the invention may lie in less than all features of a particular disclosed embodiment. Thus, it is construed that the following claims are incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and 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. [Explanation of symbols]

[0111] 100 Laser energy delivery system 101 Feedback Control System 102 First Laser System 104 Second Laser System 106 First Laser Source 108 First Optical Path 110 First Output 116 Second Laser Source 118 Second Path 120 Second Output 122 Surgical site 130 Feedback Signal 200 Endoscopic surgery system 210 Feedback Control System 212 Feedback Analyzer 214 Temperature trend circuit 216 Temperature predictor circuit 218 Controller Circuit 220 Sensors 222 Temperature Sensor 224 Pressure Sensor 230 Laser System 240 Irrigation and / or Aspiration Systems 250 User Interface Devices 252 output / display units 254 input units 300 Endoscopic Laser Lithotripsy System 301 Endoscope 310 Feedback Control System 312 Feedback Analyzer 318 Controller Circuit 324 Lighting source 325 Camera or imaging device 332 Laser Source 334 Light path 336 Distal end 338 Actuator 340 Irrigation and / or Aspiration Systems 342 Irrigation Treatment Unit 344 Irrigation and / or Aspiration Channels 346 Distal end 350 Illumination light path 360 visualization light path 370 light 410 data points 415 Temperature trend 420 data points 430 data points 700 machines 702 Hardware Processor 704 Main Memory 706 Static Memory 708 Interlink 710 Display Unit 712 Alphanumeric Input Device 714 User Interface (UI) Navigation Devices 716 Storage Devices 718 Signal Generating Device 720 Network Interface Device 721 Sensors 722 Machine-readable media 724 Data Structure or Instruction 726 Communication Network 728 Output Controller

Claims

1. An endoscopic surgery system, comprising: an endoscopic surgical device controllably coupled to the medical instrument for delivering energy to an anatomical target at a surgical site during a procedure; a temperature sensor for measuring the temperature proximate the surgical site at various times during the procedure; 1. A controller circuit comprising: generating a temperature trend or a prediction of future temperature at the surgical site based at least in part on the temperature measurements at various times; adjusting at least one of a plurality of operating parameters associated with the endoscopic surgical system to achieve or maintain a desired temperature at the surgical site during the procedure based at least in part on the generated temperature trend or the prediction of the future temperature at the surgical site. a controller circuit configured to Equipped with The plurality of operational parameters associated with the endoscopic surgery system include: the temperature of the irrigation fluid prior to application to the surgical site; irrigation flow rate, Aspiration flow rate, and a laser power setting of at least one laser system for delivering laser energy to a stone target at the surgical site; Including, The endoscopic surgery system, wherein the controller circuit is further configured to perform the adjustments according to a temperature management plan including prioritization of the plurality of operating parameters based at least in part on at least one of the generated temperature trend, the prediction of future temperature, or tissue pressure at the surgical site.

2. the controller circuit Using the generated temperature trend to determine a rate of temperature change at the surgical site; adjusting the at least one operating parameter in response to the determined rate of change of temperature exceeding a predetermined threshold. The endoscopic surgery system of claim 1 , further configured as follows:

3. the controller circuit generating a trained predictive model using the temperature measurements at the various times; further using the trained predictive model to generate a prediction of the future temperature at the surgical site; adjusting the at least one operating parameter in response to the prediction of the future temperature exceeding a temperature threshold. The endoscopic surgery system according to claim 1 or 2, further configured as follows.

4. the controller circuit using the temperature measurements at the various times to estimate a safe operating time window representing an estimate of the time it will take to reach a safe operating temperature limit at the surgical site; adjusting the at least one operating parameter in response to the estimated safe operating time window falling below a time threshold. The endoscopic surgery system according to claim 1 , further configured as follows:

5. the at least one operating parameter that is adjusted includes a laser power setting of the at least one laser system; 2. The endoscopic surgery system of claim 1, wherein the controller circuitry is further configured to switch between at least a first predetermined pulse profile and a second predetermined pulse profile based at least in part on the generated temperature trend or the prediction of the future temperature at the surgical site, the second predetermined pulse profile having a lower average power than the first predetermined pulse profile.

6. 6. The endoscopic surgery system of claim 5, wherein to adjust the laser power setting, the controller circuit is further configured to reduce the average power of laser pulses delivered to the surgical site in response to (i) the generated temperature trend indicating a temperature increase at a rate exceeding a rate threshold, or (ii) a prediction of the future temperature exceeding a temperature threshold.

7. Reducing the average power of the laser pulses The pulse width of the laser pulse, the peak power of the laser pulse; A pulse frequency, which represents the number of laser pulses per unit time; and The endoscopic surgery system of claim 6 , further comprising lowering at least one of:

8. the endoscopic surgery system comprising an irrigation and / or aspiration system configured to deliver irrigation fluid to the surgical site and to aspirate fluid from the surgical site; 8. The endoscopic surgery system of claim 1, wherein the controller circuitry is further configured to adjust at least one of irrigation flow or aspiration flow via the irrigation and / or aspiration system based at least in part on the generated temperature trend or prediction of future temperature at the surgical site to adjust the at least one operating parameter.

9. 9. The endoscopic surgery system of claim 8, wherein the controller circuitry is configured to increase at least one of the irrigation flow or the aspiration flow in response to (i) the generated temperature trend indicating a temperature increase at a rate exceeding a rate threshold, or (ii) a prediction of the future temperature exceeding a temperature threshold.

10. the endoscopic surgery system further comprising a pressure sensor configured to sense tissue pressure at the surgical site during the procedure; the controller circuit increasing the aspiration flow or decreasing the irrigation flow when the sensed pressure exceeds an upper pressure limit; increasing one or both of the irrigation flow or the aspiration flow when the sensed pressure is within a range defined by the upper and lower pressure limits; increasing the irrigation flow or decreasing the aspiration flow when the sensed pressure falls below the lower pressure limit; 9. The endoscopic surgery system of claim 8, further configured to selectively increase the irrigation flow or the aspiration flow via the irrigation and / or aspiration system.

11. the endoscopic surgery system includes an irrigation processing unit configured to modify a temperature of the irrigation fluid; The endoscopic surgery system of claim 8, wherein the controller circuit is further configured to generate a control signal to the irrigation processing unit to adjust the temperature of the irrigation fluid before it reaches the surgical site based at least in part on the generated temperature trend or the prediction of the future temperature at the surgical site.

12. The endoscopic surgery system of claim 11, wherein the irrigation processing unit includes a cooling system configured, under the control of the controller circuit, to cool the irrigation fluid before it reaches the surgical site in response to (i) the generated temperature trend indicating a temperature increase at a rate exceeding a rate threshold, or (ii) the predicted future temperature exceeding a temperature threshold.

13. The endoscopic surgery system of claim 11, wherein the irrigation processing unit includes a fluid mixer configured, under control of the controller circuit, to mix at least two sources of irrigation fluid of different temperatures before reaching the surgical site in response to (i) the generated temperature trend indicating a temperature increase at a rate exceeding a rate threshold, or (ii) the predicted future temperature exceeding a temperature threshold.

14. the endoscopic surgical device includes an optical path having an adjustable distal portion, the optical path configured to direct the laser energy to the anatomical target; The endoscopic surgery system of claim 1, wherein the controller circuitry is further configured to generate a control signal to an actuator coupled to the optical path to adjust a position or orientation of the distal portion of the optical path relative to the anatomical target based at least in part on the generated temperature trend or the prediction of the future temperature at the surgical site.

15. 15. The endoscopic surgery system of claim 1, wherein the prioritization of the multiple operating parameters includes maintaining a set value for a laser power setting and adjusting at least one of the irrigation temperature, the irrigation flow rate, or the aspiration flow rate based at least in part on at least one of the generated temperature trend, the prediction of the future temperature, or tissue pressure at the surgical site.

16. the controller circuit increasing the irrigation flow rate or decreasing the aspiration flow rate when it is determined that the pressure at the surgical site has fallen below a maximum allowable pressure, and then increasing the laser power setting; upon determining that the pressure at the surgical site is substantially close to a maximum allowable pressure, decreasing the laser power setting followed by reducing the irrigation flow rate or increasing the aspiration flow rate. The endoscopic surgery system of claim 1 , further configured as follows:

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