Adjustment of Surgical Device Settings Based on Tissue Whitening
The endoscopic surgical system addresses thermal damage risks by automatically adjusting settings based on tissue whitening detection, ensuring precise temperature control and effective treatment during procedures like laser lithotripsy.
Patent Information
- Application Number
- JP2023120013
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-07-22
- Filing Date
- 2023-07-24
- Publication Date
- 2025-06-24
- Estimated Expiration
- 2043-07-24
AI Technical Summary
Conventional manual temperature control methods for surgical sites during procedures like laser lithotripsy are inaccurate and inefficient, leading to potential thermal damage due to heat accumulation, compromising treatment efficiency and safety.
An endoscopic surgical system that automatically adjusts settings based on tissue whitening detection from images or video frames, using a control circuit to regulate laser output, irrigation, and aspiration to maintain safe surgical site temperatures.
Enhances temperature control accuracy and safety by preventing thermal damage while maintaining treatment effectiveness through automated adjustments of laser settings and fluid flows.
Smart Images

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Abstract
Description
Technical Field
[0001] Claim of Priority This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 369,099, filed Jul. 22, 2022, the content of which is incorporated herein by reference.
[0002] The present invention generally relates to an endoscopic surgical system, and more particularly to a method for adjusting one or more settings of an endoscopic surgical system based on tissue whitening detected from an image or video frame of at least a portion of a surgical site.
Background Art
[0003] Endoscopes are typically used to provide access to internal locations in a patient to provide the physician with visual access. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign objects from the patient's body. For example, a ureteroscope is used by clinicians to examine the urinary system and to perform various procedures under direct visual control. In a percutaneous nephrolithotomy (PCNL) procedure, a ureteroscope 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 passages, digestive tract, stomach, or tonsils, can be visualized and extracted.
[0004] Various medical devices, such as laser systems or plasma systems, have been used to deliver surgical laser energy to various target treatment areas, such as soft tissue or hard tissue. Examples of laser treatments include ablation, coagulation, evaporation, fragmentation, etc. In lithotripsy applications, lasers have been used to break down stone structures in the kidney, gallbladder, ureter, or to ablate large stones into smaller fragments, among several stone-forming areas. Stone fragments can be removed through the working channel of an endoscope (e.g., a ureteroscope) or can pass naturally through the patient after the procedure.
[0005] Heat accumulation is a potentially dangerous outcome of laser treatment of anatomical or stone targets, especially when relatively high-intensity laser output is used in treatment, such as laser lithotripsy to ablate or fragment stone targets of a particular size, shape, hardness, or composition. Excessive heat accumulation at or near the surgical site can result in thermal damage to non-target tissues or organs.
Summary of the Invention
Problems to be Solved by the Invention
[0006] Effective surgical site temperature control can help prevent tissue thermal damage caused by heat accumulation during medical procedures, such as laser lithotripsy or ultrasonic lithotripsy procedures. Conventionally, the temperature has been sensed from the surgical site and displayed to the user (e.g., a physician) during the procedure. The user can manually change the settings of the medical device (such as the laser output intensity) or can temporarily turn off the laser if the temperature of the surgical site reaches or exceeds the safety limit. Such manual temperature adjustment techniques may not provide accurate temperature control at the surgical site. Also, adjustment of the settings of the medical device (such as the laser output intensity) may not achieve appropriate and rapid temperature removal at the surgical site. For example, in some cases, reducing the laser output intensity or blocking the laser output may compromise treatment efficiency and / or may extend the treatment time. Although the medical device herein refers to a laser system, it should also be noted that any suitable medical device, such as an ultrasonic system that can be connected to or implemented with an endoscope to provide treatment or diagnosis of a target, is within the scope of the present invention.
Means for Solving the Problems
[0007] The present invention describes a system, device, and method for improving surgical site temperature control by automatically adjusting one or more device settings based on tissue whitening (also referred to as tissue blanching) that can be detected from an image or video frame of at least a portion of a surgical site. Tissue whitening can be an early indication of the risk of thermal damage to tissue induced by a laser. According to one embodiment, an exemplary endoscopic surgical system includes an endoscopic surgical device controllably coupled to a medical device (e.g., a laser system) and configured to deliver energy (e.g., laser energy) to a surgical site during a procedure, an imaging sensor configured to generate an image or video frame of at least a portion of the surgical site during the procedure, and a control circuit configured to analyze the generated image or video frame to determine whether the degree of heat accumulation at a first target in the surgical site exceeds a predetermined threshold. The predetermined threshold, which can be different for different types of tissue, can be represented by a threshold temperature (e.g., 42°C) at which an undesirable clinical effect in the tissue begins to occur. Since there is a positive correlation between the degree of tissue whitening and the degree of heat accumulation, the degree of heat accumulation can be inferred by evaluating the degree of tissue whitening at the first target, and the predetermined threshold for heat accumulation can be represented by the threshold degree of tissue whitening. Based on such a determination, the control circuit can determine whether to adjust at least one operating parameter associated with the endoscopic surgical system so as to avoid damaging the first target during the procedure while achieving or maintaining a therapeutic effect on a second target different from the first target in the surgical site. The surgical site temperature control techniques described herein can advantageously prevent thermal damage to tissue induced by energy (e.g., laser energy) delivered to the tissue site or can advantageously reduce the severity of thermal damage to the tissue. Various temperature control means enable a more diverse control of the temperature of the surgical site according to the state of the surgical site. Alternative temperature control means (e.g., irrigation or aspiration flow, and perfusion fluid therapy) can help avoid interruption or substantial reduction of the energy output in an endoscopic procedure (e.g., a laser or ultrasonic lithotripsy procedure).Thereby, more accurate and faster temperature control, as well as improved effectiveness of laser treatment and tissue safety, can be achieved.
[0008] Example 1 is an endoscopic surgical system comprising an endoscopic surgical device controllably coupled to a medical device for delivering energy to a surgical site during a procedure, an imaging sensor configured to generate an image or video frame of at least a portion of the surgical site during the procedure, analyzing the generated image or video frame to determine whether the degree of heat accumulation at a first target in the surgical site exceeds a predetermined threshold, and based on the determination, determining whether to adjust at least one operating parameter associated with the endoscopic surgical system so as to avoid damaging the first target during the procedure while achieving or maintaining a therapeutic effect on a second target different from the first target in the surgical site, and a control circuit configured to perform the above.
[0009] In Example 2, the first target includes tissue in the urinary system, the second target includes a target of a calculus, and the medical device optionally includes at least one laser system for delivering laser energy to treat the target of the calculus at the surgical site, as optionally included in the subject matter of Example 1.
[0010] In Example 3, the control circuit is further configured to detect, in the image or video frame, a change over time in the intensity of one or more color components associated with the first target in the image or video frame, and based on the detected change in the intensity of the one or more color components, determine whether tissue whitening has occurred at the first target, as optionally included in any one or more of the subject matters of Examples 1 - 2.
[0011] In Example 4, the endoscopic surgical device is configured to direct a targeting beam from a light source toward the surgical site, the targeting beam has characteristic color components, and the control circuit is configured to identify the footprint of the targeting beam in the generated image or video frame and determine the degree of heat accumulation at the first target based on an increase in the intensity of the characteristic color components in the vicinity of the footprint of the targeting beam, and any one or more of the subjects of Examples 1 to 3 optionally include this.
[0012] In Example 5, the control circuit is further configured to determine the rate of heat accumulation at the first target based on a comparison of images or video frames taken at different times during the procedure and adjust at least one operating parameter associated with the endoscopic surgical system according to the determined degree or rate of tissue whitening, and any one or more of the subjects of Examples 1 to 4 optionally include this.
[0013] In Example 6, the at least one operating parameter to be adjusted includes the laser output setting of at least one laser system, and the subject of Example 2 optionally includes this.
[0014] In Example 7, the laser output setting includes at least one of the pulse width of the laser pulse, the pulse shape of the laser pulse, the peak output of the laser pulse, or the pulse frequency representing the number of laser pulses per unit time, and the subject of Example 6 optionally includes this.
[0015] In Example 8, the control circuit is further configured to automatically adjust the laser output setting when it determines that the degree of heat accumulation at the first target exceeds a predetermined threshold, and the subject of Example 7 optionally includes this.
[0016] In Example 9, the control circuit is further configured to adjust the laser output setting to create a non-equilibrium irrigation flow or to promote the collapse of bubbles due to evaporation induced by laser energy, and any one or more of the subjects of Examples 6 to 8 optionally include this.
[0017] In Example 10, the laser output setting to be adjusted includes pulse sequencing representing the time distribution of laser pulses within a specific time interval, and the laser pulses are optionally included by the subject matter of Example 9 to be delivered to the second target according to the adjusted pulse sequencing.
[0018] In Example 11, the subject matter of Example 10 optionally includes that, to adjust the pulse sequencing, the control circuit is further configured to randomize the timing of each laser pulse within a specific time interval.
[0019] In Example 12, the subject matter of any one or more of Examples 6 - 11 optionally includes that, to adjust the laser output setting, the control circuit is further configured to prioritize the adjustment of the pulse shape or the pulse sequencing over the adjustment of the average output of the laser pulses.
[0020] In Example 13, an irrigation and / or aspiration system configured to provide irrigation fluid to the surgical site and to provide aspiration of fluid from the surgical site is optionally included by the subject matter of any one or more of Examples 1 - 12.
[0021] In Example 14, the subject matter of Example 13 optionally includes that at least one operating parameter associated with the endoscopic surgical system includes at least one of an irrigation flow or an aspiration flow respectively associated with the irrigation system and the aspiration system.
[0022] In Example 15, a pressure sensor configured to sense pressure at a surgical site during a procedure, wherein the control circuit increases the suction flow but not the irrigation flow when the sensed pressure exceeds a pressure upper limit, increases one or both of the irrigation flow or the suction flow when the sensed pressure is within a range defined by the pressure upper limit and a pressure lower limit, and increases the irrigation flow but not the suction flow when the sensed pressure drops below the pressure lower limit, and is further configured to selectively increase the irrigation flow or the suction flow via an irrigation and / or suction system, the pressure sensor, optionally including the subject matter of Example 14.
[0023] In Example 16, an irrigation fluid treatment unit configured to change the temperature of the irrigation fluid, wherein the control circuit is further configured to generate a control signal to the irrigation fluid treatment unit to adjust the temperature of the irrigation fluid before it reaches the surgical site when it determines that the degree of heat accumulation at a first target exceeds a predetermined threshold, the irrigation fluid treatment unit, optionally including one or more of the subjects of Examples 13 - 15.
[0024] In Example 17, an endoscopic surgical device includes an optical path with an adjustable distal portion, the optical path configured to direct laser energy towards a surgical site, and the control circuit is further configured to generate a control signal to an actuator coupled to the optical path to adjust the position or orientation of the distal portion of the optical path with respect to the surgical site when it determines that the degree of heat accumulation at a first target exceeds a predetermined threshold, optionally including one or more of the subjects of Examples 2 and 6 - 12.
[0025] In Example 18, at least one operating parameter associated with an endoscopic surgical system includes at least one of the temperature of the irrigation fluid before it is applied to the surgical site, the irrigation flow rate, the suction flow rate, or the laser output setting of a laser system, optionally including one or more of the subjects of Examples 1 - 17.
[0026] In Example 19, the control circuit is further configured to perform an adjustment by a bias towards one of the operating parameters based at least in part on at least one of the degree of heat accumulation at the first target or the pressure at the surgical site, which the subject matter of Example 18 optionally includes.
[0027] In Example 20, the control circuit is further configured to adjust at least one of the irrigation flow rate or the suction flow rate before adjusting the laser output setting when it is determined that the pressure at the surgical site is substantially less than the maximum allowable pressure, which the subject matter of Example 19 optionally includes.
[0028] In Example 21, the control circuit is further configured to adjust the laser output setting before adjusting the irrigation flow rate or the suction flow rate when it is determined that the pressure at the surgical site is substantially close to the maximum allowable pressure, which the subject matter of any one or more of Examples 19 to 20 optionally includes.
[0029] In Example 22, a user interface device configured to generate a warning when it is determined that the degree of heat accumulation at the first target exceeds a predetermined threshold is optionally included in the subject matter of any one or more of Examples 1 to 21.
[0030] In Example 23, a user interface device, in which the control circuit is further configured to generate a recommended adjustment of at least one operating parameter and to receive user input for confirming, rejecting, or changing the recommended adjustment, is optionally included in the subject matter of any one or more of Examples 1 to 22.
[0031] Example 24 is a method for controlling the temperature at a patient's surgical site during an endoscopic procedure using an endoscopic surgical system, the method comprising: directing energy generated by a medical device towards the surgical site; using an imaging sensor to generate an image or video frame of at least a portion of the surgical site; analyzing the generated image or video frame to determine whether the degree of heat accumulation at a first target in the surgical site exceeds a predetermined threshold; and based on the determination, determining whether to adjust at least one operating parameter associated with the endoscopic surgical system so as to avoid damaging the first target during the procedure while achieving or maintaining a therapeutic effect on a second target different from the first target in the surgical site.
[0032] In Example 25, the first target includes tissue in the urinary system, the second target includes a stone target, and the energy generated by the medical device optionally includes laser energy generated by at least one laser system for treating the stone target at the surgical site, as optionally included in the subject matter of Example 24.
[0033] In Example 26, the at least one operating parameter to be adjusted optionally includes a laser output setting of at least one laser system, the laser output setting including at least one of a pulse width of a laser pulse, a pulse shape of a laser pulse, a peak output of a laser pulse, or a pulse frequency representing the number of laser pulses per unit time, as optionally included in the subject matter of Example 25.
[0034] In Example 27, the laser output setting to be adjusted optionally includes a pulse sequencing representing the temporal distribution of laser pulses within a specific time interval, and the laser pulses are delivered to the surgical site according to an adjusted pulse sequencing that creates a non-equilibrium irrigation flow and promotes the collapse of bubbles due to evaporation induced by the laser pulses, as optionally included in the subject matter of Example 26.
[0035] In Example 28, the adjustment of the pulse sequencing, which the subject matter of Example 27 optionally includes, includes randomizing the timing of each of the laser pulses within a specific time interval.
[0036] In Example 29, in an image or video frame, detecting a change over time in the intensity of one or more color components associated with a first target in the image or video frame, and determining whether tissue whitening has occurred at the first target based at least in part on the detected change in the intensity of the one or more color components, which one or more of the subject matters of Examples 24 to 28 optionally include.
[0037] In Example 30, directing a aiming beam from a light source towards a surgical site, the aiming beam having a characteristic color component, identifying the footprint of the aiming beam in the generated image or video frame, and determining the degree of heat accumulation at the first target based at least in part on an increase in the intensity of the characteristic color component in the vicinity of the footprint of the aiming beam, which one or more of the subject matters of Examples 24 to 29 optionally include.
[0038] In Example 31, determining the rate of heat accumulation at the first target based on a comparison of images or video frames taken at different times during the procedure, and adjusting at least one operating parameter associated with the endoscopic surgical system according to the determined degree or rate of tissue whitening, which one or more of the subject matters of Examples 24 to 30 optionally include.
[0039] In Example 32, adjusting at least one operating parameter associated with the endoscopic surgical system, which one or more of the subject matters of Examples 24 to 31 optionally include, includes adjusting at least one of the irrigation flow of the perfusion fluid to the surgical site or the suction flow of the fluid out of the surgical site.
[0040] In Example 33, the step of using a pressure sensor to sense the pressure at the surgical site during the procedure, and adjusting at least one of the irrigation flow or the suction flow, includes increasing the suction flow but not increasing the irrigation flow when the sensed pressure exceeds the pressure upper limit, increasing one or both of the irrigation flow or the suction flow when the sensed pressure is within the range defined by the pressure upper limit and the pressure lower limit, and increasing the irrigation flow but not increasing the suction flow when the sensed pressure drops below the pressure lower limit. The step is optionally included in the subject matter of Example 32.
[0041] In Example 34, adjusting at least one operating parameter includes adjusting the temperature of the irrigation fluid before it reaches the surgical site via an irrigation fluid treatment unit connected to the irrigation and / or suction system when it is determined that the degree of heat accumulation at the first target exceeds a predetermined threshold. The subject matter of any one or more of Examples 24 to 33 is optionally included.
[0042] In Example 35, adjusting at least one operating parameter includes adjusting the position or orientation of the distal portion of the optical path to the surgical site and directing energy through the optical path to the surgical site when it is determined that the degree of heat accumulation at the first target exceeds a predetermined threshold. The subject matter of any one or more of Examples 24 to 34 is optionally included.
[0043] In Example 36, the step of prioritizing the adjustment of two or more operating parameters of the endoscopic surgical system, including the temperature of the irrigation fluid before it is applied to the surgical site, the irrigation flow rate, the suction flow rate, and the laser output setting of the laser system, is optionally included in the subject matter of any one or more of Examples 24 to 35.
[0044] In Example 37, when it is determined that the degree of heat accumulation in the first target exceeds a predetermined threshold, it includes, optionally, any one or more of the subjects of Examples 24 to 36: a step of generating a warning, or a step of generating a recommended adjustment of at least one operating parameter and receiving user input for determining, rejecting, or modifying the recommended adjustment.
[0045] This summary is a general description of some of the teachings of this application and is not intended to be an exclusive or exhaustive discussion of the subject matter. Further details regarding the subject matter can be 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 by viewing the drawings that form a part of the detailed description, and each of the detailed description and the drawings is not to be construed in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents.
[0046] Various embodiments are shown using examples in the figures of the accompanying drawings. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the subject matter.
Brief Description of the Drawings
[0047]
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Best Mode for Carrying Out the Invention
[0048] Endoscopic procedures are medical procedures that look at and operate on internal organs and / or deliver energy (e.g., laser energy or ultrasonic energy) to a target body area to achieve a specific diagnostic or therapeutic effect. For example, laser endoscopes have been used for the treatment of soft and hard tissues (e.g., damaging or destroying cancer cells) or in the application of lithotripsy. During the procedure, the operator can insert a scope through an incision in the patient's ureter into the patient's kidney. Through the scope, the operator can find a specific stone in the kidney or upper ureter and break the stone into smaller fragments by illuminating the stone with a relatively high-power infrared laser beam through the scope. The laser beam can ablate the stone into smaller fragments. Therefore, the stone fragments can be removed from the kidney. The scope can be an endoscope, a pyeloureteroscope, and / or a cystoscope.
[0049] Laser energy delivered to an environment for laser treatment (e.g., ablation and fragmentation of a calculus target) of at least a portion of a surgical site and an anatomical target may cause heat accumulation at or near the surgical site. Specifically, when a relatively high-intensity laser output is used, such as for ablating or fragmenting a calculus target of a specific size, hardness, or composition, it may cause heat accumulation. To prevent dangerous outcomes such as thermal damage to tissue, the temperature within the body or at the surgical site can be monitored during the procedure to ensure that it remains within a safe temperature range. Conventional temperature control of the surgical site involves monitoring the temperature in real time. When the temperature reading reaches or exceeds a safety limit (e.g., a pre-set threshold), the user (e.g., a physician) can reduce or temporarily disable the laser output intensity. Such manual temperature adjustment has several limitations. First, the temperature of the surgical site can rise rapidly, especially when a high laser output is used during the procedure, and reducing or blocking the laser output when the temperature reading reaches or exceeds the safety limit may be too late to prevent laser-induced thermal damage to the tissue. Second, the timing of laser output adjustment is important for preventing tissue damage without compromising the efficiency of ablation or fragmentation. Manual adjustment of the laser output not only burdens the operating physician but may lack accuracy and predictability, especially for less experienced physicians. Third, reducing or blocking the laser output may not produce appropriate and rapid temperature removal in a specific surgical site or tissue biostructure. In some cases, it may not be possible to block or significantly reduce the laser output without compromising the efficiency of ablation. For at least the above reasons, the inventor recognized the unmet need for devices and methods for automatic and more efficient temperature control to prevent heat accumulation at the surgical site during procedures such as laser lithotripsy procedures.
[0050] The present invention describes a system, device, and method for automatic control of surgical device settings based on tissue whitening that can be detected from an image or video frame of at least a portion of a surgical site. An exemplary endoscopic surgical system includes an endoscopic surgical device controllably coupled to a medical device (e.g., a laser system) and configured to deliver energy (e.g., laser energy) to a surgical site during a procedure, an imaging sensor configured to generate an image or video frame of at least a portion of the surgical site during the procedure, and a control circuit configured to analyze the generated image or video frame to determine whether a degree of heat accumulation at a first target (e.g., tissue) in the surgical site exceeds a predetermined threshold. Since there is a positive correlation between the degree of tissue whitening and the degree of heat accumulation, the determination of the degree of heat accumulation can be based on whether tissue whitening has occurred and the degree of heat accumulation at the first target. Based on such a determination, the control circuit can determine whether to adjust at least one operating parameter associated with the endoscopic surgical system so as to avoid damaging the first target during the procedure while achieving or maintaining a therapeutic effect on a second target (e.g., a calculus target) different from the first target in the surgical site.
[0051] The systems, devices, and methods according to various embodiments contemplated herein improve real-time temperature control of the surgical site during laser endoscopic procedures. The features described herein may be further used with respect to endoscopes, laser surgery, laser lithotripsy or ultrasonic lithotripsy, irradiation parameter setting, and / or spectroscopy. Examples of targets and applications can include laser lithotripsy or ultrasonic lithotripsy of kidney stones, and laser resection or evaporation of soft tissue. In an example of an endoscopic system incorporating features as described herein, the condition of the surgical site, such as excessive heat accumulation, is detected by analyzing at least a portion of an image or video frame of the surgical site taken during the procedure and identifying tissue whitening as an early indication of tissue thermal damage from the image or video frame. Compared to conventional displays of temperature measurements, the image-based temperature control of the surgical site as described in this document enables the detection of tissue whitening at an early stage of heat accumulation in the surgical site. The identification of tissue whitening can enable the taking of earlier and more effective preventive measures before the temperature rises to critical levels, thereby preventing thermal damage to the tissue and improving patient safety.
[0052] This document describes various temperature control means for regulating the temperature of the surgical site, such as keeping the temperature below a critical level or within a desired safety range. In the examples, the laser output intensity or one or more laser irradiation parameters (e.g., one or more laser pulse parameters such as output, duration, frequency, or pulse shape, exposure time, or emission angle) can be adjusted. In some examples, the pulse sequencing (representing the temporal distribution of laser pulses within a specific time) can be adjusted or randomized to create a non-equilibrium state of the irrigation flow. Such a flow can help prevent or reduce the possibility of bubbles (induced by laser pulses) due to evaporation by continuously hitting the same area of tissue that can exacerbate local heat accumulation. For example, adjusting the laser settings can result in a non-equilibrium flow that directs the bubbles created by the laser energy over a wide range of tissue areas rather than a single tissue area where tissue whitening is observed. In one embodiment, the non-equilibrium irrigation flow can promote the collapse of bubbles due to evaporation at or near the surgical site. In addition or as an alternative to adjusting the laser output settings, regulating the inflow of irrigation to and / or the outflow (suction) from the surgical site can also keep the temperature of the surgical site under control. In some embodiments, the perfusion fluid may be treated (e.g., cooled) before flowing to the surgical site to more rapidly and effectively reduce the temperature of the surgical site. One or more of such temperature control means may be optimized based on the state of the surgical site. For example, based on the pressure of the tissue at or near the surgical site, the irrigation or suction flow may be adjusted to create a temperature control effect while achieving or maintaining a desired ambient pressure at or near the surgical site. In some examples, multiple temperature control means (e.g., adjusting the laser output or irradiation parameters, adjusting the irrigation or suction flow, or providing perfusion fluid treatment) can be combined or arranged to form a stepwise temperature control strategy based on the state of the surgical site.Compared to conventional techniques that focus on controlling laser output, the various temperature control means and staged temperature control strategies as contemplated in this document advantageously enable more diverse control of the temperature of the surgical site in accordance with the condition of the surgical site. By using alternative temperature control means such as irrigation or suction flow and perfusion fluid therapy, it is possible to help avoid interruption or substantial reduction of the laser energy output during a laser lithotripsy procedure so that the effectiveness of the laser treatment is not significantly impaired. As a result, more accurate and faster temperature control, as well as improved laser treatment effectiveness and tissue safety, can be achieved.
[0053] FIG. 1 is a block diagram showing an example of a laser energy delivery system 100 configured to provide laser treatment to an anatomical target at or near a surgical site 122 in a subject's body, such as an anatomical structure (e.g., an abnormality such as soft tissue, hard tissue, or cancerous tissue) or a stone structure (e.g., a kidney stone, a pancreaticobiliary stone, or a gallbladder stone). In some examples, the laser energy delivery system 100 can deliver precisely controlled therapeutic procedures (e.g., tissue ablation, coagulation, or vaporization) to tissue or other anatomical structures, or treatment of non-anatomical structures (e.g., ablation or dust removal of a stone structure).
[0054] The laser energy delivery system 100 may include a feedback control system 101 and at least one laser system 102 operably communicating with the feedback control system 101. By way of example and not limitation, FIG. 1 shows a laser feedback system connected to a first laser system 102 and, optionally (shown in dashed lines), a second laser system 104. Additional laser systems are contemplated within the scope of the present disclosure. The first laser system 102 may include a first laser source 106 and associated components such as a power supply, a display device, and a cooling system. The first laser system 102 may also include a first optical path 108 operably coupled to the first laser source 106. In the 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.
[0055] The feedback control system 101 can receive a feedback signal 130 from a target. Various feedback signals can be used to achieve or maintain a desired state, such as a desired temperature at or near the surgical site, in order to improve the effectiveness of treatment and to prevent or reduce the severity of thermal damage to tissue induced by a laser, by controlling laser delivery, laser energy output, and / or other system parameters. In an example, the feedback signal 130 can include a signal indicating the state of the surgical site, such as the temperature or pressure at or near the surgical site during the procedure. In an example, the feedback signal 130 can include an acoustic signal generated by a laser pulse propagating through a medium (e.g., liquid and vapor), being projected onto a target, and causing the target to vibrate. In another example, the feedback signal 130 can include a reflected electromagnetic signal (e.g., illumination light emitted from a light source and reflected). In yet another example, the feedback signal 130 can include a reflected laser signal. The feedback control system 101 can analyze the feedback signal 130, generate signal characteristics from the feedback signal 130, and control the laser output (e.g., energy intensity, or other laser irradiation parameters such as output, duration, frequency, or pulse shape, exposure time, or emission angle). In an example, the feedback signal 130 can include an image or video frame of at least a portion of the surgical site, such as that generated by an imaging sensor during the procedure. The feedback control system 101 can analyze the image or video frame to determine whether the degree of heat accumulation in a first target (e.g., tissue) at the surgical site exceeds a predetermined threshold. The predetermined threshold, which can vary for different types of tissue, can be represented by a threshold temperature (e.g., 42°C) at which an undesirable clinical effect in the tissue begins to occur. Since there is a positive correlation between the degree of tissue whitening and the degree of heat accumulation, the degree of heat accumulation can be inferred by evaluating the degree of tissue whitening in the first target, and the predetermined threshold for heat accumulation can be represented by the degree of the threshold of tissue whitening.Based on the determination of the degree of heat accumulation (e.g., tissue whitening in the first target), the feedback control system 101 can adjust the laser output or laser delivery, and / or other system parameters to achieve or maintain the therapeutic effect on the second target (e.g., the target of a calculus) at a surgical site different from the first target while avoiding damaging the first target during the treatment. In the example, the first target can be tissue in the urinary system, and the second target can be the target of a kidney stone. The feedback control system 101 can achieve or maintain the desired state of the desired surgical site, such as the temperature of the desired surgical site during the lithotripsy procedure, to maintain the therapeutic effect of ablating or fragmenting the target of the kidney stone while preventing or reducing the severity of thermal damage to the tissue induced by the laser, by adjusting the laser output or laser delivery, and / or other system parameters.
[0056] As shown in FIG. 1, based on the analysis of the feedback signal 130, the feedback control system 101 can control the first laser system 102 and / or the second laser system 104 to generate an appropriate laser output to achieve the desired therapeutic effect and to achieve or maintain the desired state, such as the desired temperature at or near the surgical site, to prevent or reduce the severity of thermal damage to the tissue induced by the laser. For example, the feedback control system 101 can monitor the characteristics of the target structure during a treatment procedure (e.g., ablating a calculus such as a kidney stone into smaller fragments) to determine whether the tissue has been appropriately ablated prior to another treatment procedure (e.g., coagulation of blood vessels).
[0057] In the example, the first laser source 106 can be configured to provide a first output 110. The first output 110 can extend over a first wavelength range, such as corresponding to a portion of the absorption spectrum of the target structure. Since the first output 110 extends over a wavelength range corresponding to the absorption spectrum of the tissue, effective ablation and / or carbonization of the target structure can be provided.
[0058] In the example, the first laser source 106 may be configured such that the first output 110 emitted in the first wavelength range has a high absorption (e.g., greater than about 250 cm -1 -1) by the tissue. In an exemplary aspect, the first laser source 106 can emit the first output 110 between about 1900 nanometers (nm) and about 3000 nm (e.g., corresponding to high absorption by water), and / or between about 400 nm and about 520 nm (e.g., corresponding to high absorption by oxyhemoglobin and / or deoxyhemoglobin). Clearly, there are two main mechanisms of light interaction with tissue, namely absorption and scattering. When the absorption of the tissue is high (absorption coefficient greater than 250 cm -1 -1), the first absorption mechanism is dominant, and when the absorption is low (absorption coefficient less than 250 cm -1 -1), such as a laser in the wavelength range of 800 - 1100 nm, the scattering mechanism is dominant.
[0059] Various commercially available medical - grade laser systems may be suitable for the first laser source 106. For example, semiconductor lasers such as InXGa1 - XN semiconductor lasers that provide the first output 110 in a first wavelength range between about 515 nm and about 520 nm, or between about 370 nm and about 493 nm, may be used. Alternatively, infrared (IR) lasers such as those summarized in Table 1 below may be used.
[0060]
Table 1
[0061] An 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 device, and a cooling system. The second laser system 104 may be either operably separated from the first laser source 106 or operably 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) operably 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.
[0062] In certain aspects, the second output 120 can extend over a second wavelength range different from the first wavelength range. Thus, there may be no overlap between the first wavelength range and the second wavelength range. Alternatively, the first wavelength range and the second wavelength range may have at least a partial overlap with each other. In advantageous aspects of the present disclosure, the second wavelength range may not correspond to a portion of the absorption spectrum of a target structure where incident radiation is strongly absorbed by previously ablated or carbonized tissue. In some such aspects, the second output 120 can advantageously not ablate non-carbonized tissue. In another embodiment, the second output 120 can ablate previously ablated and carbonized tissue. In additional embodiments, the second output 120 can provide an additional therapeutic effect. For example, the second output 120 may be more suitable for coagulating tissue or blood vessels.
[0063] FIG. 2 is a block diagram showing an endoscopic surgical system 200 with automatic surgical site state control and at least a portion of an environment in which the system 200 can operate. The system 200 can be an embodiment of the laser energy delivery system 100 or, among several lithotripsy systems, an embodiment of a lithotripsy system that can be used to destroy hardened masses such as kidney stones, gastric stones, and gallstones. The system 200 can monitor and control the state of the surgical site 122 or around it during laser treatment to maintain the temperature of the surgical site at a substantially desired level during the treatment to prevent or reduce the severity of laser-induced thermal damage to tissue. In this document, the term "substantially" means ± 10%, and in some embodiments, ± 5%.
[0064] The endoscopic surgical 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 an embodiment of the feedback control system 101 of the laser energy delivery system 100, may include a feedback analyzer 212 and a control circuit 218. According to an example embodiment, the feedback control system 210 may include a processing device, 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, as well as any combination of such components to perform one or more of the functions attributed to the feedback control system 210. The feedback analyzer 212 can be communicatively coupled to one or more sensors 220, receive a feedback signal from the sensors 220, and analyze the feedback signal to generate one or more signal characteristics that can be used to control the state of the surgical site. In an example as shown in FIG. 2, the one or more sensors 220 may include an imaging sensor 222 configured to generate an image or video frame of at least a portion of the surgical site 122 during the procedure. The imaging sensor 222 may be included in an imaging system that further includes an optical lens system. Examples of the image sensor 222 may include a CCD or CMOS camera that can sense at ultraviolet (UV), visible light (VIS), or infrared (IR) wavelengths. The imaging sensor 222 can position the distal portion of the endoscope for use during the procedure, an example of which is shown in FIG. 3. The imaging sensor 222 can generate images or video frames at different times. The one or more sensors 220 may additionally include a pressure sensor 224 to sense the pressure of the surgical site during the procedure.
[0065] The image or video frame of the surgical site can be transmitted to the feedback analysis device 212. The feedback analysis device 212 may include an image analysis circuit 214 and a tissue whitening detection circuit 216. The image analysis circuit 214 can process the image or video frame to detect image features indicating the temporal change in the color of the tissue from the image or video frame. The tissue whitening detection circuit 216 can use the detected image features to detect an indication of tissue whitening. Tissue whitening can indicate the degree of heat accumulation in a first target (e.g., tissue) at the surgical site. In an example, the image analysis circuit 214 can compare images or video frames taken at different times during the procedure and identify changes in the intensity of one or more characteristic color components (e.g., CMOS or CCD color components) at a registered location in the image or video frame. The registered location corresponding to a particular tissue site can be specified by the user. In an example, a targeting beam can be used to assist in specifying the registered location corresponding to a particular tissue site, as will be discussed later. The tissue whitening detection circuit 216 compares the intensity of one or more characteristic color components (e.g., RGB values) at the registered location with respective threshold values for the color "white" (RGB(255, 255, 255)) or a predetermined "whitened" color (e.g., RGB(240, 240, 240)) (e.g., threshold RGB values, RGB TH) can be compared. When the intensity values of one or more color components (e.g., from 0 to 255) are sufficiently close to the "white" color within a specific margin (e.g., RGB values within the range of (240 - 255, 240 - 255, 240 - 255)), tissue whitening is considered to be detected. In some examples, the image analysis circuit 214 can compare continuously captured images or perform frame-by-frame comparison of video frames, and determine the rate of change of color intensity towards the "white" color or a predetermined "whitened" color at the registered location. The tissue whitening detection circuit 216 can compare the rate of change of color intensity with a speed threshold, and when the rate of change of color intensity exceeds the speed threshold, it can determine the presence of tissue whitening. The tissue whitening thus detected indicates that the degree of heat accumulation in the tissue at the surgical site exceeds a predetermined threshold corresponding to the RGB TH or the threshold rate of change of threshold color intensity.
[0066] The control circuit 218 can be connected by a wired or wireless connection to the feedback analysis device 212. The control circuit 218 can generate a control signal for adjusting the operating parameters associated with the system 200 to substantially achieve or maintain a desired temperature (e.g., ±10%, or in some cases ±5%) at the surgical site in response to the identified tissue whitening. In an example, the tissue whitening detection circuit 216 determines the degree of tissue whitening ΔRGB based on the difference between the intensity values of the color components (e.g., RGB values) of the image or video frame taken at time t (RGB t ) and the threshold value RGB for the "white" color (RGB(255, 255, 255)) or a predetermined "whitened" color (e.g., RGB(240, 240, 240)), that is, ΔRGB = RGB TH - RGB t - RGB THcan be determined. A smaller ΔRGB value indicates a higher degree of tissue whitening (i.e., closer to "white" or a predetermined "whitened" color), and thus a higher temperature at the surgical site and a higher risk of tissue thermal damage. In another example, the tissue whitening detection circuit 216 can determine the speed of tissue whitening ΔRGB / Δt (i.e., the amount of change in color intensity towards the "white" color or a predetermined "whitened" color per unit time). A higher tissue whitening speed ΔRGB / Δt indicates faster heat accumulation at the surgical site and, by extension, a higher risk of tissue thermal damage. The control circuit 218 can determine the aggressiveness of parameter adjustment (e.g., by adjusting laser output settings, irrigation flow rate and / or suction flow rate, or irrigation fluid temperature control) based on the degree of tissue whitening ΔRGB or the speed of tissue whitening ΔRGB / Δt. For example, if a higher degree of tissue whitening or a higher speed of tissue whitening (i.e., faster tissue whitening) is detected, the control circuit 218 can provide a more aggressive adjustment of one or more system parameters (e.g., a greater reduction in laser output, a higher irrigation flow rate and / or a higher suction flow rate, or a greater cooling of the irrigation fluid before it flows to the surgical site) to bring the temperature of the surgical site under control.
[0067] A laser system 230, which is an example of a laser system 102 or a laser system 104 as shown in FIG. 1, may include a laser source (such as a first laser source 106) and an optical path (such as a first optical path 108) for directing laser energy towards a surgical site. The laser source can generate laser energy according to a laser output intensity or one or more laser irradiation parameters (for example, one or more laser pulse parameters such as output, duration, frequency, or pulse shape, exposure time, or emission angle). At least some of such laser parameters can be programmably or adjustably either automatically by a control circuit 218 or the like, or manually by a user via a user interface device 250. In response to an indication of tissue whitening (as detected by a tissue whitening detection circuit 216), the control circuit 218 can automatically adjust the laser output setting according to one or more of the degree of tissue whitening ΔRGB or the speed of tissue whitening ΔRGB / Δt. For example, the control circuit 218 can automatically reduce the average output of the laser pulses delivered to the surgical site, such as by reducing one or more of the pulse width of the laser pulses, the peak output of the laser pulses, or the pulse frequency representing the number of laser pulses per unit time. Reducing the average output of the laser pulses can reduce the laser-induced heating effect at or near the surgical site, thereby preventing thermal damage to the tissue and improving the safety of the patient during the procedure.
[0068] In addition to or as an alternative to adjusting one or more laser output parameters, the control circuit 218 can automatically select one of a plurality of predetermined laser output settings or pulse profiles with different energy output levels according to the degree of tissue whitening ΔRGB or the tissue whitening speed ΔRGB / Δt. In an example, the control circuit 218 can automatically switch between a first "high output" setting and a second "low output" setting, each with a value of a respective predetermined parameter. The "low output" setting has a lower average output than the "high output" setting. When the degree of tissue whitening ΔRGB or the tissue whitening speed ΔRGB / Δt exceeds their respective thresholds, the "low output" setting will be automatically selected.
[0069] In some examples, the laser system 230 can include a first laser source 232 and a different second laser source 234. The first laser source 232 can generate therapeutic laser energy directed at a target at the surgical site through an optical path such as the first optical path 108. Examples of the first laser source 232 can include, among others, a thulium laser, Ho:YAG, Nd:YAG, and CO2. The second laser source 234 can be optically coupled to the same or a different optical path, such as the second optical path 118. The second laser source 234 can generate an aiming beam directed at the target through the same or a different optical path. For example, the wavelength of the aiming beam can be in the range of 500 - 550 nm. In some examples, the second laser source 234 can emit at least two different aiming beams with different characteristics, such as one or more of wavelength, output level, or emission pattern. For example, the first aiming beam can have a wavelength in the range from 500 nm to 550 nm, and the second aiming beam can have a wavelength in the range from 635 nm to 690 nm. The characteristics of the different aiming beams can be selected based on the visibility of the aiming beams in an image or video frame of the surgical site.
[0070] The aiming beam can be emitted when the target is illuminated by light (such as the illumination light source 324 as shown in FIG. 3). In some examples, the aiming beam can be generated using a light source different from the second laser source 234. The light source can generate an aiming beam with a clearly different color to distinguish from the illuminated background of the surgical site. By way of example, and not limitation, the aiming beam can be green light in the range of approximately 520 nm, or in another example can be red in the range of approximately 620 nm.
[0071] The aiming beam incident on the tissue at the surgical site can be captured by the imaging sensor 222 and shown as the footprint of the aiming beam in an image or video frame. FIG. 4 shows an endoscopic image 410 including a graphic depiction of the illuminated target site within the field of view of the imaging sensor 222 and a circular aiming beam footprint 412. Also shown in the image 410 is an image of the distal tip 413 of the optical path (e.g., the distal end 336 of the optical path 334 as shown in FIG. 3), and an image of the distal portion 414 of the endoscope (such as the endoscope 301 as shown in FIG. 3). When a colored (e.g., green) aiming beam is used, the aiming beam footprint 412 can appear green in the endoscopic image 410. The tissue whitening detection circuit 216 can identify the aiming beam footprint 412 from each of a series of images or video frames of the surgical site and can detect tissue whitening from a portion of the image or video frame at or near the aiming beam footprint. In one embodiment, when the tissue becomes "whitened", a colored (e.g., green or red) aiming beam incident on the "whitened" tissue can appear brighter in the image or video frame than in "non-whitened" tissue. For example, for a green aiming beam, a brighter green footprint can indicate a higher degree of tissue whitening than a duller green footprint. The brightness of the color of the footprint can be measured as the intensity or saturation of the color (e.g., RGB values). In the example, the tissue whitening detection circuit 216 can detect tissue whitening (and further determine the degree of tissue whitening ΔRGB and / or the tissue whitening rate ΔRGB / Δt) based on an increase in color intensity at or near the aiming beam footprint. Based on the tissue whitening indicated by the aiming beam, the control circuit 218 can adjust one or more system parameters to bring the temperature of the surgical site under control.
[0072] As described above, in response to the detection of tissue whitening (by the tissue whitening detection circuit 216), the control circuit 218 can automatically adjust a laser output setting including one or more laser irradiation parameters according to the degree of tissue whitening ΔRGB or the speed of tissue whitening ΔRGB / Δt to reduce the temperature of the surgical site. Maintaining the desired state (e.g., temperature) of the surgical site can help achieve or maintain the desired therapeutic effect (e.g., ablation or fragmentation of the stone target) at the target of the treatment at the surgical site, while avoiding damaging the tissue in the vicinity of the treatment target during the procedure. An example of a laser irradiation parameter adjusted to control the temperature of the surgical site is pulse sequencing (also referred to as pulse profile). Pulse sequencing represents the timing or time distribution of laser pulses within a specific time. Adjusting the pulse sequencing can change the heat distribution in the surgical space, such as by changing the formation, flow, and amount of evaporation-induced bubbles generated by the pulsed laser beam. Such evaporation-induced bubbles can be formed when the laser pulse propagates through the surgical space into contact with the tissue wall. The tissue region in contact with the evaporation-induced bubbles tends to be heated by the bubbles. For example, in some cases, a temperature increase of 25°C to 30°C can occur in the tissue region where the bubbles contact. Also, the temperature increase of the tissue at or near the surgical site can be affected by the size of the bubbles and the position of the optical path (e.g., the fiber-tissue distance). Therefore, reducing the size and number of evaporation-induced bubbles and / or redistributing the bubbles over a wide range of tissue regions (to prevent the bubbles from constantly contacting the same tissue region) can help reduce the temperature of the surgical site and prevent or help reduce the severity of thermal damage to the tissue.
[0073] A constant pulse sequencing of the laser may facilitate the bubbles to progress towards a point of constant contact with the tissue wall in an equilibrium state. Under such an equilibrium state, a predictable turbulent flow of bubbles towards the same tissue region may always hit the tissue region and cause heat accumulation. To mitigate the disruption effect on a single point of the tissue that constantly absorbs the heat induced by the laser through the bubble flow, the control circuit 218 generates a control signal to the first laser source 232 to adjust the laser output settings, including the laser pulse sequencing, so as to prevent the bubbles from progressing in an equilibrium state and continuously hitting the same region of the tissue, in response to the identification of tissue whitening in an image or video frame. Specifically, by changing the pulse sequencing (i.e., changing the temporal distribution of the laser pulses within a specific time), a non-equilibrium irrigation flow or a more disordered and unpredictable irrigation flow can be created in which the bubbles hit a wider range of tissue regions than a single tissue region where tissue whitening may be observed. The pulse sequencing can be changed periodically or at a time specified by the user. FIGS. 5A-5D show an example of changing the pulse sequencing from a first pulse profile 510 (in FIG. 5A) to a different second pulse profile 520 (in FIG. 5B) within a given time period T, and the resulting irrigation flow and bubble state. The second pulse profile 520 is characterized by a distribution of random laser pulses 522 that is different from the distribution of pulses 512 of the first pulse profile 510. In the example, a random number generator can be used to determine the timing for the laser pulses 522 within a given time period T. FIG. 5C shows the equilibrium state created by the laser pulses emitted from the distal end 501 into the surgical space of the tissue 502 according to the first pulse profile 510. The equilibrium state is characterized by a predictable and steady turbulent flow 530, in which the bubbles 532 due to evaporation flow towards site "A" of the tissue 502 and always hit the same tissue site "A", causing heat accumulation there. In contrast, FIG. 5D shows the non-equilibrium state created by the laser pulses delivered according to the second pulse profile 520.The non-equilibrium state is characterized by a more unpredictable irrigation flow 540 with fewer bubbles 542 due to less evaporation because of the higher likelihood of bubble collapse. Bubbles 542 in the non-equilibrium state can cover a wide range of regions of the tissue 502 rather than a single tissue region "A", thereby preventing or reducing the severity of thermal damage to the tissue at the surgical site.
[0074] In some examples, in response to an indication of tissue whitening (such as detected by the tissue whitening detection circuit 216), the control circuit 218 can generate a control signal to an actuator coupled to the optical path (e.g., a laser fiber) of the laser system 230 to adjust the position or orientation of the adjustable distal portion (laser emission portion) of the optical path with respect to the anatomical target at or near the surgical site. Adjusting the position or orientation of the adjustable distal portion of the optical path can include adjusting the distance between the distal portion and the anatomical target ("fiber-target" distance), or the aiming angle of the distal portion with respect to the anatomical target, in response to one or more of the degree of tissue whitening ΔRGB or the rate of tissue whitening ΔRGB / Δt provided by the tissue whitening detection circuit 216. For example, the control circuit 218 can automatically move the distal portion of the optical path away from the surgical site (i.e., increase the fiber-target distance) via the actuator, and / or rotate the distal portion of the optical path to aim the laser away from the surgical site (to increase the aiming angle). By increasing the fiber-target distance and / or increasing the aiming angle, the density of the laser energy incident on the surgical site and the laser-induced heat transmitted to the surgical site can be reduced.
[0075] While the target intended to be treated is not an anatomical tissue or organ, but a mass such as a calculus structure at the surgical site in a specific treatment (e.g., lithotripsy), the identification of tissue whitening can be an indication of insufficient aiming of the laser fiber. Adjusting the position or orientation of the distal portion of the optical path (e.g., via an actuator representing tissue whitening) to change the aiming angle or the "fiber-target" distance can redirect the laser energy back to the intended calculus target while improving the effectiveness of the treatment and preventing thermal damage to the tissue.
[0076] The irrigation and / or aspiration system 240 can comprise one or more irrigation and / or aspiration sources capable of providing a flow of irrigation fluid (also referred to as a perfusion fluid such as an aqueous saline solution) to the surgical site through at least one irrigation passage, such as those included in an endoscope during the procedure. The irrigation fluid can facilitate the removal of tissue fragments, stone fragments, and other unwanted substances through the aspiration passage. The irrigation flow may have a cooling effect on the tissue at and near the surgical site and the surgical tool (e.g., an endoscopic tissue removal device) and can help dissipate the heat generated during ablation of the calculus. Examples of the irrigation and / or aspiration system 240 are considered below with reference to FIG. 3.
[0077] In some examples, in response to an indication of tissue whitening (such as detected by the tissue whitening detection circuit 216), the control circuit 218 can automatically adjust one or more irrigation parameters, such as the irrigation flow or the aspiration flow, according to the degree of tissue whitening ΔRGB or the tissue whitening speed ΔRGB / Δt provided by the tissue whitening detection circuit 216. For example, the control circuit 218 can automatically increase the irrigation flow from the irrigation source to the surgical site to increase convective heat transfer. Additionally or alternatively, the control circuit 218 can automatically increase the aspiration flow (or aspiration pressure) to more effectively draw the fluid away from the surgical site, improve heat dissipation, and reduce the temperature of the surgical site.
[0078] The application of an irrigation or suction flow to control the temperature of the surgical site can vary the pressure at or near the surgical site. For example, an irrigation flow to the surgical site will generally increase the pressure at the surgical site (a positive pressure change), while a suction pressure (i.e., outflow) will generally decrease the pressure at the surgical site (a negative pressure change). Such positive or negative pressure changes induced by irrigation and / or suction can be harmful to the tissue or organ at or near the surgical site if not properly regulated. To keep the pressure of the anatomical environment under control during the procedure and to avoid or reduce tissue damage related to pressure, the system 200 can include a pressure sensor 224 to sense the pressure at the surgical site during the procedure. When the degree of tissue whitening ΔRGB or the tissue whitening speed ΔRGB / Δt meets their respective conditions (e.g., ΔRGB is less than a threshold value, or ΔRGB / Δt exceeds a threshold value), the control circuit 218 can selectively activate or adjust the irrigation flow or the suction flow based on the measured pressure (P) at the surgical site. For example, an increase in the irrigation flow to the surgical site can introduce a positive pressure change at or near the surgical site, and if the measured pressure at the surgical site exceeds a predetermined or user-specified pressure upper limit (also referred to as the maximum allowable pressure) P max (P > P max ), the control circuit 218 can decrease the temperature of the surgical site to prevent a further increase in the pressure at the surgical site, but can increase the suction flow to avoid increasing the irrigation flow. For example, the irrigation flow can be maintained at its flow rate, set to a reduced flow rate, or temporarily deactivated. The increased suction flow can also help to lower the pressure at the surgical site to a level within the desired pressure range. If the measured pressure at the surgical site is within the desired pressure range between the pressure upper limit P max and the pressure lower limit P min (P min < P < P max) The control circuit 218 can increase one or both of the irrigation flow and the suction flow to lower the temperature of the surgical site. An increase in the suction flow can introduce a negative pressure change at or near the surgical site, and when the measured pressure at the surgical site is below the pressure lower limit P min (P < P min ), the control circuit 218 can increase the irrigation flow to the surgical site to lower the temperature of the surgical site, but can avoid increasing the suction flow to prevent a further decrease in the pressure at the surgical site. For example, the suction flow can be maintained at its flow rate, set to a reduced flow rate, or temporarily deactivated. The increased irrigation flow can also help increase the pressure at the surgical site to a level within the desired pressure range.
[0079] In some examples, the irrigation and / or suction system 240 can include a perfusion fluid treatment unit that can adjust the temperature of the perfusion fluid (irrigation solution) before it is applied to the surgical site. In some examples, in response to an indication of tissue whitening (such as detected by the tissue whitening detection circuit 216), the control circuit 218 can generate a control signal to the perfusion fluid treatment unit to change the temperature of the perfusion fluid according to one or more of the degree of tissue whitening ΔRGB or the tissue whitening speed ΔRGB / Δt provided by the tissue whitening detection circuit 216. In an example, the perfusion fluid treatment unit can include a cooling system (such as a radiator or an in-line cooler) that can cool the perfusion fluid before it reaches the surgical site under the control of the control circuit 218. In another example, the perfusion fluid treatment unit can include a fluid mixer that can mix at least two perfusion fluids at different temperatures before they reach the surgical site under the control of the control circuit 218. The cooled irrigation via the cooling system or the mixed perfusion fluid via the fluid mixer can improve the convective heat transfer when applied to the surgical site and can effectively and efficiently reduce the temperature of the surgical site.
[0080] In some examples, the control circuit 218 can maintain the temperature of the surgical site at a substantially desired level or range according to a temperature management plan. The temperature management plan can include, among other things, for example, changing the laser output setting or one or more laser irradiation parameters, adjusting the position or orientation of the distal portion of the optical path (e.g., laser fiber), activating or adjusting the irrigation flow to and / or the suction flow away from the surgical site, or changing the temperature of the irrigation fluid before it is applied to the surgical site, and can include a prioritized order of two or more of the temperature control means described above. The temperature management plan can be programmed or modified by the user, such as via the user interface device 250. The order of the temperature control means can be determined based on availability (e.g., irrigation fluid cooling system), efficiency of temperature control, or potential adverse effects at the surgical site. In an example, the temperature management plan can be programmed with a bias towards adjusting other device settings (e.g., position or orientation of the distal portion of the optical path, irrigation and / or suction flow, irrigation fluid temperature) suitable for maintaining the temperature of the surgical site while maintaining the optimal or user-selected laser output setting. Maintaining the laser output setting can be desirable during a laser lithotripsy procedure to shorten the treatment time and ensure the effectiveness and efficiency of the treatment. Also, adjusting the laser output setting (e.g., reducing the average laser output) can have a slow effect on the temperature of the surgical site. In another example, the temperature management plan can be programmed such that irrigation fluid temperature control (e.g., cooling the irrigation fluid before it is applied to the surgical site) can be used before attempting to adjust the irrigation or suction flow to prevent pressure fluctuations induced by irrigation and / or suction near or at the surgical site. For example, in response to an indication of tissue whitening (such as detected by the tissue whitening detection circuit 216), the control circuit 218 can first generate a control signal to the irrigation fluid processing unit of the irrigation and / or suction system 240 to cool the irrigation fluid before it is applied to the surgical site.Next, the feedback control system 210 can re-evaluate the image or video frame to determine whether tissue whitening still persists or deteriorates. In such a case, the control circuit 218 can generate a control signal to the irrigation and / or suction system 240 to increase the irrigation flow and / or suction flow to lower the temperature of the surgical site. The choice between the irrigation flow and the suction flow, or the order in which the irrigation flow and the suction flow are applied, can be based on the pressure at the surgical site, as previously discussed. For example, to maintain the temperature of the surgical site substantially at a desired level or range during the procedure, the system can compare the current pressure P at the surgical site with a predetermined pressure upper limit or a pressure upper limit P specified by the user. max and. The current pressure P at the surgical site can be substantially P max If it is less than (for example, if the difference between P and P max exceeds a threshold), the irrigation inflow rate can be increased to increase the convective heat transfer through irrigation. Additionally or alternatively, the suction flow can be increased to efficiently remove heat from the surgical site. In contrast, if the current pressure P at the surgical site is substantially close to P max (for example, within a margin specified by the user such as ±10% or within a predetermined margin), instead of increasing the irrigation inflow rate, the laser output setting can be decreased. In embodiments where the suction flow is actively controlled (for example, via a pump), if the current pressure P at the surgical site is substantially close to P max , the suction flow rate can be increased to lower the pressure at the surgical site, as an alternative or in addition to decreasing the laser output setting. While body tissues can generally tolerate some positive pressure changes, many organs are relatively defenseless against negative pressure changes. Thus, in some examples, increasing the irrigation flow can be attempted before activating or increasing the suction flow.
[0081] Next, the feedback control system 210 can re-evaluate the image or video frame to determine whether tissue whitening still persists or deteriorates. In such a case, the control circuit 218 can generate a control signal to the laser system 230 to adjust the position or orientation of the distal portion of the optical path or to change the laser output setting or one or more laser irradiation parameters. The laser irradiation parameters can be adjusted in a predetermined order or priority. For example, adjustment of the pulse shape or pulse sequencing (temporal distribution of laser pulses within a specific time) is given priority over adjustment of the average output of the laser pulses. The stacked and continuous operation or adjustment of different temperature control means can help maintain the desired state of the surgical site (e.g., temperature, pressure) during the procedure without compromising the effectiveness and efficiency of the treatment or imposing an additional risk of tissue damage at or near the surgical site.
[0082] The user interface device 250 can communicate operably with the feedback control system. The user interface device 250 can include, for example, an output / display unit 252 for displaying information, including images, pressures, or other information sensed by the sensor 220, feedback signals generated by the feedback analyzer 212, including detected indications of tissue whitening, the degree of tissue whitening ΔRGB, the rate of tissue whitening ΔRGB / Δt, or the current device settings such as laser output setting, irrigation flow rate, or suction flow rate, including the state of the surgical site. The output / display unit 252 can display UI elements, including visual elements, warnings, tactile feedback, or any combination thereof. The output / display unit 252 can generate a warning about a potentially dangerous state at or near the surgical site, such as an elevated temperature indicated by tissue whitening or an elevated pressure at the surgical site. The warning can be provided in an audible form, a visible form, a tactile form, or other recognizable form for others.
[0083] The user interface device 250 may include one or more input units 254 to accept programming of the user's device, such as parameter values used to detect tissue whitening (e.g., including RGB values that pre-determine the color of "whitened", threshold values for the degree of tissue whitening ΔRGB and / or the tissue whitening speed ΔRGB / Δt). The user input may include parameter adjustments of the laser output setting, irrigation flow, or suction flow, among several device parameters for controlling the temperature of the surgical site. In some examples, the user can provide a temperature management plan that determines the prioritized order of two or more temperature control means as described above via one or more input units 254. For example, the user can first direct the control circuit 218 to reduce the irrigation fluid temperature (if available) without adjusting the laser output of the irrigation flow rate. Next, if tissue whitening at the surgical site persists or worsens, the flow rate can be increased and / or the irrigation fluid temperature can be decreased. Examples of prioritizing means for controlling the surgical site are discussed below with reference to FIGS. 7A-7B.
[0084] In some examples, the output / display unit 252 can generate recommendations for taking preventive actions to prevent tissue damage, such as recommended adjustments to the laser output or other system parameters. The user can provide input via one or more input units 254 to confirm, reject, or change the recommended adjustments.
[0085] FIG. 3 shows an example of an endoscopic laser lithotripsy system 300 that may be an example of the endoscopic surgical system 200 with automatic surgical site state control. The endoscopic laser lithotripsy system 300 may include an endoscope 301, a feedback control system 310, an actuator 338, an irrigation and / or aspiration system 340, and a perfusion fluid treatment unit 342. The endoscope 301 has a proximal portion and an elongated distal portion configured to be inserted into a patient's surgical site during an endoscopic laser lithotripsy procedure. The endoscope 301 can provide not only visual inspection or treatment of soft tissue (e.g., non-calcified tissue) or hard tissue (e.g., calcified tissue), but also visualization, destruction, or other treatment of kidney stones, other stones, or other targets. As shown in FIG. 3, the endoscope 301 can include or provide an optical system for visualization and illumination, such as a visualization optical path 360 and an illumination optical path 350 that can each extend longitudinally along the elongated body of the endoscope 301. An eyepiece, camera, or imaging display device can be provided in or coupled to the visualization optical path 360 to enable visual recognition of the target area by a user or machine at or near the distal end of the endoscope 301. The target area can 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 can include, for example, a xenon lamp, a light emitting diode (LED), a laser diode (LD), or any combination thereof. In an example, the light source 324 can include two or more light sources that emit light having different illumination characteristics, referred to as illumination modes. In an example, the illumination modes can 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. Special light illumination can concentrate and increase light of a specific wavelength, resulting in, for example, better visualization of tissue or other structures at the surgical site.
[0086] The lithotripsy system 300 can comprise, or be connectable to, at least one laser source 332, which can be an example of the first laser source 106, the second laser source 116, or a laser source included in the laser system 230. The laser source 332 can be mechanically and optically connected to an optical path 334, which can comprise 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, can be introduced through a proximal access port to extend within a working channel of the endoscope 301 or a similar instrument, another longitudinal passage, or a lumen.
[0087] In some examples, the laser source 332 can comprise a first laser source (such as the first laser source 232) for generating a treatment beam and a second different laser source for generating an aiming beam (such as the second laser source 234). The treatment beam and the aiming beam can be directed to the target through the same or different optical paths. In some examples, the aiming beam can be generated using a light source different from the second laser source. As described previously with reference to FIG. 2, the aiming beam can have a distinctly different color (e.g., green or red) to distinguish it from the illuminated background of the surgical site.
[0088] The lithotripsy system 300 may include a camera or imaging device 325. The camera or imaging device 325 may include an imaging sensor (such as imaging sensor 222) capable of generating an imaging signal of a target in response to electromagnetic radiation of the target (such as illumination light 370) at or near the surgical site. The imaging signal may be transmitted through optical path 360 or, alternatively, through optical path 334 to a feedback control system 310 (an embodiment of feedback control system 210). The feedback control system 310 may include a feedback analyzer 312 and a control circuit 318. In an example, the imaging signal may pass through an optical splitter before reaching the feedback analyzer 312. The feedback analyzer 312 may include a spectrometer capable of generating one or more spectral characteristics from the imaging data. The feedback analyzer 312 may use the one or more spectral characteristics to recognize the target as a target of a calculus or an anatomical target at or near the surgical site, or to classify the target as a certain type of tissue or a certain type of calculus with a clearly different composition. In some examples, the feedback analyzer 312 may use the spectral characteristics to calculate or estimate the fiber-target distance. The control circuit 318 may generate a control signal to the laser source 332 for adjusting the laser output setting, a control signal to the actuator 338 for adjusting the position or orientation of the distal end 346 of the irrigation and / or aspiration passage 344 (such as the fiber-tissue distance, or the aiming angle), or a control signal to the irrigation and / or aspiration system 340 for adjusting the irrigation flow or the aspiration flow based on the structure, composition, or type of the target.
[0089] In some examples, the camera or imaging device 325 can include an imaging sensor (such as imaging sensor 222) that can generate an image or video frame of the target. The image or video frame of the surgical site can be transmitted to the feedback analysis device 312. Similar to the feedback analysis device 212, the feedback analysis device 312 (an embodiment of the feedback analysis device 212) can detect an indication of tissue whitening from the image or video frame of the surgical site. In an example, tissue whitening can be determined based on a comparison of the intensity of the color components (e.g., RGB values) with a threshold value for a predetermined "whitened" color (RGB TH ). In another example, the feedback analysis device 312 can perform a frame-by-frame comparison of the video frame to determine the rate of change of the color intensity towards the color "white" (RGB(255, 255, 255)) or a predetermined "whitened" color. The feedback analysis device 312 can determine the degree of tissue whitening ΔRGB or the rate of tissue whitening ΔRGB / Δt based on the difference between the intensity values (RGB values) (RGB t ) of the image or video frame taken at time t and the threshold value RGB TH , as previously discussed with reference to FIG. 2.
[0090] In some examples, the feedback analysis device 312 can detect tissue whitening (and can determine the degree of tissue whitening ΔRGB or the rate of tissue whitening ΔRGB / Δt) from a footprint of the aiming beam incident on the tissue at the surgical site or a portion of the image or video frame in the vicinity thereof, as described with reference to FIG. 4. Tissue whitening (including the degree and rate of tissue whitening) can be detected based on an increase in the color intensity in the aiming beam footprint or in its vicinity.
[0091] The detection of tissue whitening, including the degree and / or speed of tissue whitening, can be used by the control circuit 318 to regulate the temperature of the surgical site, such as by adjusting the operating parameters of one or more devices, such as the laser source 332, the irrigation and / or aspiration system 340, or the irrigation fluid treatment unit 342.
[0092] The irrigation and / or aspiration system 340 (an embodiment of the irrigation and / or aspiration system 240) can include an irrigation source and an aspiration source that are each fluidly coupled to the working channel of the endoscope 301, such as an irrigation and / or aspiration passage 344. The irrigation and / or aspiration passage 344 can be a common unified passage for performing irrigation inflow and aspiration outflow at different times. Alternatively, in some examples, the irrigation and / or aspiration passage 344 may comprise two separate passages, such as an irrigation passage and an aspiration passage. The separate irrigation passage and aspiration passage can be parallel to each other or coaxially arranged on a common axis, such as in a nested configuration. The irrigation source can function to provide an irrigation fluid (irrigation solution) to the irrigation and / or aspiration passage 344. The irrigation fluid can be fed by gravity or pressurized. In an example, a pump can create a pressurized irrigation flow to the surgical site through the irrigation and / or aspiration passage 344. The aspiration source can function to pull, suck, draw, aspirate, or otherwise move or remove fluid and undesirable substances from the surgical site to a container. The aspiration source can perform the aforementioned functions by generating a vacuum, suction, or negative pressure and applying it to the irrigation and / or aspiration passage 344.
[0093] The feedback analyzer 312 of the feedback control system 310 can receive feedback information generated by one or more sensors, including, for example, an imaging sensor in a camera or imaging device 325 and a pressure sensor 224 configured to sense the pressure at the surgical site during a procedure. The pressure sensor 224 can be positioned at the distal end 336 of the optical path 334. Alternatively, the pressure sensor 224 may be positioned at other locations, such as the distal end 346 of the irrigation and / or aspiration passage 344. As described above, the feedback analyzer 312 can detect an indication of tissue whitening from an image or video frame of the surgical site and can determine the degree of tissue whitening ΔRGB or the rate of tissue whitening ΔRGB / Δt. According to the identified degree and / or rate of tissue whitening, the control circuit 318 (an embodiment of the control circuit 218) can automatically adjust one or more system parameters or prompt the user to manually adjust them to regulate the temperature of the surgical site to prevent or reduce the severity of laser-induced thermal damage to the tissue.
[0094] Various temperature control means can be used to regulate the temperature of the surgical site during a procedure. In an example, the control circuit 318 can generate a control signal to the laser source 332 to automatically adjust the laser output settings, including one or more laser irradiation parameters, in response to the degree of tissue whitening ΔRGB or the rate of tissue whitening ΔRGB / Δt. In an example, the laser output settings can be adjusted by changing the pulse sequencing (i.e., changing the temporal distribution of the laser pulses within a specific time) to create a non-equilibrium irrigation flow where the bubbles hit a wider range of tissue areas than a single tissue area where tissue whitening may be observed, or a more chaotic and unpredictable irrigation flow, as described above with reference to FIGS. 5B and 5D.
[0095] In addition to or as an alternative to adjusting the laser output settings, in some examples, the control circuit 318 can generate a control signal to the actuator 338 to adjust the position of the laser emission end relative to the target at the surgical site. The actuator 338 can be coupled to a portion of the optical path 334 and can be in electrical communication with the control circuit 318. In an example, the actuator 338 can be positioned at or near the distal end of the endoscope 301. The actuator 338 can actuate the distal end 336 of the optical path 334 with respect to the working channel or other longitudinal passage of the endoscope 301 or with respect to another reference location to which the endoscope 301 can serve as a coordinate system, or enable other longitudinal or rotational positioning of the distal end 336, and can include one or more of an electromagnetic element, an electrostatic element, a piezoelectric element, or other actuating element. In response to the identified tissue whitening, the control circuit 318 can adjust the longitudinal position by moving the distal end 336 further away from the surgical site (to increase the fiber-target distance), and / or adjust the rotational position by maneuvering the distal end 336 away from the surgical site (to increase the aiming angle), etc., and can actuate the actuator 338 to adjust the position or orientation of the distal end 336 of the optical path 334.
[0096] In yet another example, the control circuit 318 can generate control signals to the irrigation and / or aspiration system 340 to automatically adjust one or more irrigation parameters, such as an irrigation flow or an aspiration flow. The irrigation flow or aspiration flow can help dissipate heat generated during a procedure (laser treatment of tissue or fragmentation of a calculus). The irrigation flow or aspiration flow can also assist in the removal of fluid and unwanted substances (e.g., tissue fragments or stone fragments), and can maintain the pressure at the surgical site under control, such as to substantially maintain the pressure at a user-specified pressure level (e.g., a user-specified pressure with a tolerance such as ±5 - 10%). In response to a specified tissue whitening, the control circuit 318 can control the irrigation and / or aspiration system 340 to automatically increase the irrigation flow to the surgical site to increase convective heat transfer and / or to increase the aspiration flow (or aspiration pressure) to draw fluid away from the surgical site, so as to improve heat dissipation and reduce the temperature at the surgical site. In some examples, the irrigation flow or aspiration flow can be selectively actuated or adjusted based on the pressure at the surgical site monitored via the pressure sensor 224 as described previously with reference to FIG. 2.
[0097] In another example, the control circuit 318 can generate control signals to the perfusion fluid treatment unit 342 to automatically adjust the temperature of the irrigation before it is applied to the surgical site. The perfusion fluid treatment unit 342 can include a cooling system (e.g., a radiator or an in-line cooler) for cooling a perfusion fluid or fluid mixer to mix at least two perfusion fluids of different temperatures. In response to a specified tissue whitening, the control circuit 318 can control the irrigation and / or aspiration system 340 to automatically cool the irrigation fluid via the cooling system or fluid mixer. Thus, the irrigation / aspiration system 340 can apply the cooled irrigation to the surgical site via the irrigation and / or aspiration passage 344 to improve convective heat transfer and effectively and efficiently reduce the temperature at the surgical site.
[0098] Among other things, the control circuit 318 can generate or accept from the user a temperature management plan that determines the prioritized order of two or more of the temperature control means described above, including, for example, changing the laser output setting or one or more laser irradiation parameters, adjusting the position or orientation of the distal portion of the optical path (e.g., laser fiber), actuating or adjusting the irrigation flow to the surgical site and / or the suction flow away from the surgical site, or changing the temperature of the irrigation fluid before it is applied to the surgical site.
[0099] FIG. 6 is a flow diagram showing a method 600 for controlling the state of a surgical site (such as the temperature of the surgical site) during an endoscopic procedure for treating an anatomical target (e.g., soft tissue, hard tissue, cancerous tissue, or a stone structure such as a kidney stone, pancreatic duct stone, or gallbladder stone). The method 600 can be implemented in the endoscopic surgical system 200 or the endoscopic laser lithotripsy system 300, or can be executed by the endoscopic surgical system 200 or the endoscopic laser lithotripsy system 300. The process of the method 600 is depicted in one flow diagram, but need not be performed in a specific order. In various examples, some of the processes may be performed in an order different from that shown herein.
[0100] At 610, laser energy (e.g., a laser beam or a series of laser pulses) is delivered to an anatomical target. The laser energy can be generated by a laser source (the first laser source 106, the second laser source 116, or the laser source 332) and transmitted through an optical path (the first optical path 108, the second optical path 118, or the optical path 334). At 620, images or video frames of the surgical site taken at different times can be generated using an imaging sensor such as the imaging sensor 222. At 630, the images or video frames can be analyzed using, for example, the image analysis circuit 214 and are used to determine whether the degree of heat accumulation in a first target (e.g., tissue) at the surgical site exceeds a predetermined threshold. In an example, the determination of the degree of heat accumulation can be made based on whether tissue whitening (brightening of the color of the tissue) can be detected in the image or video frame and the detected degree of tissue whitening. In an example, images or video frames taken at different times can be compared to each other to identify changes in the intensity of one or more color components (e.g., RGB values) at registered locations in the image or video frame. The registered location corresponding to the tissue site can be specified by the user. In an example, the intensity of one or more color components can be compared to respective threshold values (RGB TH ) for the color "white" (RGB(255, 255, 255)) or a predetermined "whitened" color (e.g., RGB(240, 240, 240)). If the intensity value of one or more color components (e.g., values from 0 to 255) is close enough to the color "white" within a specific margin (e.g., RGB values within the range (240 - 255, 240 - 255, 240 - 255)), at 630, tissue whitening is considered to be detected. In some examples, frame - by - frame comparison of video frames or comparison of continuously captured images can be used to determine the speed of color intensity change towards the color "white" (RGB(255, 255, 255)) or a predetermined "whitened" color at registered locations in the image or video frame. If the speed of color intensity change exceeds a speed threshold, it is considered tissue whitening. The tissue whitening thus detected indicates that the degree of heat accumulation in the tissue at the surgical site is RGBTH or indicates exceeding a threshold corresponding to the threshold color intensity change speed.
[0101] In some examples, in addition to detecting an indication of tissue whitening, the degree and / or speed of tissue whitening can be determined at 630. The degree of tissue whitening is the intensity value (e.g., RGB value) of the color components of the image or video frame taken at time t(RGB t ), and the threshold value RGB for the color component representing the "white" color or a predetermined "whitened" color TH The difference between, that is, ΔRGB = RGB t - RGB TH It can be determined based on. A smaller ΔRGB value indicates a higher degree of tissue whitening, and thus a higher temperature at the surgical site and a higher risk of tissue thermal damage. The speed of tissue whitening ΔRGB / Δt represents the amount of change in color intensity towards the "white" color or a predetermined "whitened" color per unit time. A higher tissue whitening speed ΔRGB / Δt indicates faster heat accumulation at the surgical site and, by extension, a higher risk of tissue thermal damage.
[0102] In an example, the aiming beam can be used to assist in identifying tissue whitening at a registered location in an image or video frame. The aiming beam, such as that generated by a second laser source 234 or other light source, may be emitted when the target is illuminated. The aiming beam may have a distinctly different color (green light in the range of approximately 520 nm, or red in the range of approximately 620 nm) to distinguish it from the illuminated background of the surgical site, as shown in FIG. 4. When the aiming beam incident on the tissue at the surgical site is within the field of view of the imaging sensor, it can be captured by the imaging sensor. The footprint of the aiming beam can be identified from the image or video frame of the surgical site. When a colored (e.g., green) aiming beam is used, the aiming beam footprint may also be shown in green in the image or video frame. As previously described with reference to FIG. 4, when the tissue becomes "whitened", the colored (e.g., green or red) aiming beam incident on the "whitened" tissue can appear brighter in the image or video frame than in the "non-whitened" tissue. Tissue whitening can be detected from a portion of the image or video frame in the footprint of the aiming beam or in its vicinity. The degree of tissue whitening ΔRGB, or the tissue whitening speed ΔRGB / Δt, can also be determined based on the increase in color intensity in the aiming beam footprint or in its vicinity.
[0103] At 640, at least one operating parameter associated with the endoscopic surgical system can be adjusted at least in part based on the degree of heat accumulation at a first target at the surgical site, such as tissue whitening detected from an image or video frame, using control circuit 218 or control circuit 318. By adjusting the at least one operating parameter, a desired state of the surgical site, such as a desired temperature, can be maintained during the procedure. Maintaining the desired state of the surgical site (e.g., temperature) avoids potential thermal damage to tissue due to overheating induced by the laser at the surgical site, while helping to achieve or maintain a therapeutic effect at the surgical site (e.g., ablation or fragmentation of a stone target). Adjustment of the at least one operating parameter can be performed automatically by, for example, control circuit 218 or control circuit 318, which is electrically coupled to various devices of the endoscopic surgical system. Alternatively, the identified tissue whitening can be presented to the user via a user interface device 250 or the like. The user can be warned about the temperature increase at the surgical site and be recommended to take appropriate preventive actions, such as adjusting the laser output or other system parameters.
[0104] As described above with reference to FIGS. 2 and 3, among numerous temperature control means, for example, changing the laser output setting or one or more laser irradiation parameters, adjusting the position or orientation of the distal portion of the optical path (e.g., laser fiber), activating or adjusting the irrigation flow to the surgical site and / or the suction flow away from the surgical site, or changing the temperature of the irrigation fluid before it is applied to the surgical site, can be attempted. In some examples, the temperature of the surgical site can be controlled according to a temperature management plan. The temperature management plan can include the order of priority of two or more temperature controls described above. The temperature management plan can be programmed or modified by the user, such as via the user interface device 250. The order of the temperature control means can be determined based on availability (e.g., irrigation fluid cooling system), the efficiency of temperature control, or potential adverse effects at the surgical site. In some examples, the aggressiveness of parameter adjustment (e.g., by adjusting the laser output setting, irrigation flow rate and / or suction flow rate, or irrigation fluid temperature control) can be determined based on the degree of tissue whitening ΔRGB, or the rate of tissue whitening ΔRGB / Δt. For example, if a higher degree of tissue whitening, or a higher rate of tissue whitening (i.e., faster tissue whitening) is detected, the control circuit 218 can provide a more aggressive adjustment of one or more system parameters (e.g., a greater reduction in laser output, a higher irrigation flow rate and / or a higher suction flow rate, or a greater cooling of the irrigation fluid before it flows to the surgical site) to bring the temperature of the surgical site under control.
[0105] FIG. 7A is a flowchart showing an example method of generating such a temperature management plan based on the state of the surgical site, including, for example, whitening and pressure of the surgical site. The temperature management plan can include an ordered sequence of two or more prioritized temperature controls as described above. At 701, the tissue whitening identified at 630 can be evaluated against a criterion of tissue whitening, such as a threshold of tissue whitening exceeding a speed threshold or a degree of ΔRGB of tissue whitening less than the speed. At 702, pressure can be sensed at the surgical site, such as using pressure sensor 224. At 703, the measured pressure P of the surgical site is compared with a predetermined pressure upper limit P, also referred to as the maximum allowable pressure max , or a pressure upper limit P specified by the user max . At 704, a temperature management plan can be determined based on the temperature confirmation at 701 and the pressure confirmation at 703. The availability (e.g., perfusion fluid cooling system) and efficiency of the temperature control means, or potential adverse effects on the surgical site, may be considered to determine an individual temperature management plan for the patient. The temperature management plan can include, among other things, changing, for example, the laser output setting or one or more laser irradiation parameters, adjusting the position or orientation of the distal portion of the optical path (e.g., laser fiber), activating or adjusting the perfusion flow to and / or the suction flow away from the surgical site, or changing the temperature of the perfusion fluid before it is applied to the surgical site, and can include an ordered sequence of two or more prioritized temperature control means as described above. In the example as shown in FIG. 7A, when the temperature trend or prediction of the future temperature of the surgical site meets the temperature adjustment criterion at 701, the priority order between adjusting the laser output setting and adjusting the perfusion or suction flow can be at least partially based on whether the pressure P of the surgical site has reached a level substantially close to the pressure upper limit P at 705 max . If the pressure P of the surgical site is substantially less than P max (e.g., if the difference between P and P max exceeds a threshold), the perfusion flow rate can be increased at 706. If the pressure P of the surgical site is substantially P maxWhen close to (e.g., within ±10% etc., within the margin specified by the user of P max or within a predetermined margin), the prioritization of the temperature control means can be determined based on whether options for increasing the suction flow are available at 707. If the suction flow is not available or cannot be actuated by the user, the laser output setting can be adjusted, such as by decreasing the laser output at 708. However, at 707, if the suction flow is available and can be actuated by the user, the suction flow rate can be increased at 709. Following the temperature control operation in any of steps 706, 708, and 709, other temperature control means may be attempted in an on-demand mode (e.g., actuated by the user). Monitoring of the temperature of the surgical site can continue at 620.
[0106] FIG. 7B is a flowchart showing an example of a temperature management plan by a prioritization means for controlling the temperature of a surgical site, which can be an embodiment of step 640 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. At 710, the tissue whitening specified at 630 can be evaluated against a criterion for tissue whitening, such as a threshold of tissue whitening exceeding a speed threshold or a degree of tissue whitening ΔRGB less than the speed. If the criterion is not met at 710, the temperature of the surgical site is considered normal, the parameters are not adjusted, and monitoring of the temperature of the surgical site can continue at 620. If the criterion is met at 710, an option for cooling the perfusion fluid before it flows to the surgical site is provided at 720. If the option for perfusion fluid cooling is available and is selected (e.g., by the user), at 722, the perfusion fluid can be cooled before reaching the surgical site using a cooling system (e.g., a radiator or in-line cooler included in the perfusion fluid treatment unit 342), or by mixing at least two perfusion fluid sources at different temperatures. The cooled irrigation can be applied to the surgical site to improve convective heat transfer at the surgical site. Monitoring of the temperature of the surgical site can continue at 620.
[0107] If the option of perfusion fluid cooling is not available, or is not selected at 720, the option of using an irrigation and / or aspiration system (such as irrigation and / or aspiration system 240, or irrigation and / or aspiration system 340) is provided at 730. As previously discussed with reference to FIGS. 2 and 3, the irrigation and / or aspiration system can provide an irrigation inflow to the surgical site and / or a suction flow (outflow) of fluid from the surgical site. In addition to assisting in the removal of tissue fragments, stone fragments, and other undesirable substances during the procedure, the irrigation flow and the suction flow also have a cooling effect on the tissue at or near the surgical site. At 730, if the option of irrigation and / or aspiration is not available, or is not selected (e.g., by the user), the laser output settings can be adjusted at 732. For example, the average output of the laser pulse can be reduced, such as by reducing one or more of the pulse width of the laser pulse, the peak output of the laser pulse, or the pulse frequency representing the number of laser pulses per unit time. Reducing the average output of the laser pulse can reduce the laser-induced heating effect at or near the surgical site, thereby preventing thermal damage to the tissue and improving the safety of the patient during the procedure. The amount (aggressiveness) of adjustment of the laser output settings, including one or more laser irradiation parameters, can depend on the degree or speed of tissue whitening. In the example, the laser irradiation parameters adjusted at 732 can include pulse sequencing parameters representing the timing or temporal distribution of the laser pulses within a specific time period. As previously described with reference to FIGS. 5A and 5C, a certain pulse sequencing of the laser can potentially facilitate the progression of bubbles due to laser-induced evaporation to a point of constant contact with the walls of the tissue in an equilibrium state. Under such an equilibrium state, predictable turbulence of the bubbles towards the same tissue area can always hit the tissue area and cause heat accumulation.As previously described with reference to FIGS. 5B and 5D, adjusting the laser pulse sequencing can help redistribute the bubbles over a wide range of tissue regions and prevent the bubbles from advancing in an equilibrium state and hitting the same region of the tissue continuously. The non-equilibrium state of the flow can promote the collapse of the bubbles due to evaporation and can also reduce the number and size of the bubbles due to evaporation, thereby reducing the temperature of the surgical site and preventing thermal damage to the tissue.
[0108] In addition to or as an alternative to adjusting the laser output settings, including one or more laser irradiation parameters, in some examples, the position or orientation of the distal portion of the optical path relative to the anatomical target at the surgical site can be adjusted, such as via the actuator 338, to adjust the position or orientation of the distal end 336 of the optical path 334. The position or orientation can be adjusted to decrease the density of the laser energy incident on the surgical site and the laser-induced heat transmitted to the surgical site by increasing the fiber-target distance and / or by increasing the aiming angle. Monitoring of the temperature of the surgical site can be continued at 620.
[0109] Irrigation and / or suction options are available and, when selected at 730, the pressure can be sensed at the surgical site, such as using the pressure sensor 224, at 740. Depending on the sensed pressure (P) at the surgical site, one or both of the irrigation flow or the suction flow can be selectively actuated or adjusted to achieve temperature control at the temperature of the surgical site. At 750, the measured pressure at the surgical site is compared to a predetermined pressure upper limit P max , or a pressure upper limit P specified by the user max . The measured pressure at the surgical site is compared to P max . If the measured pressure at the surgical site exceeds P (P > P max)、At 752, only the aspiration flow rate is increased (the irrigation flow rate cannot be increased) to lower the temperature of the surgical site. Additionally or alternatively, the irrigation flow rate can be decreased to lower the pressure at the surgical site. An increase in the irrigation flow to the surgical site can induce a positive pressure change at or near the surgical site, so further increases in the irrigation flow should be avoided to prevent further increases in the pressure at the surgical site. If the measured pressure at the surgical site is P max less, the measured pressure at the surgical site can be further compared at 760 to a predetermined pressure lower limit P min or a pressure lower limit P min specified by the user. If the measured pressure at the surgical site is within the range defined by P min and P max (P min < P < P max ), at 770, one or both of the irrigation flow rate or the aspiration flow rate can be increased to lower the temperature of the surgical site. However, at 560, if the measured pressure at the surgical site drops below the pressure lower limit P min (P < P min ), at 762, only the irrigation flow rate to the surgical site is increased (the aspiration flow rate cannot be increased) to lower the temperature of the surgical site while avoiding increasing the aspiration flow to prevent further decreases in the pressure at the surgical site. Additionally or alternatively, the aspiration flow rate can be decreased to increase the pressure at the surgical site. An increase in the aspiration flow can induce a negative pressure change at or near the surgical site, so further increases in the aspiration flow should be avoided to prevent further decreases in the pressure at the surgical site. After adjusting the irrigation or aspiration flow at 752, 762, or 770, monitoring of the temperature of the surgical site can continue at 620.
[0110] FIG. 8 generally shows a block diagram of a machine 800 of an example in which any one or more of the techniques (e.g., methodologies) contemplated herein may be implemented. Portions of this description may be applicable to the computing frameworks of various portions of the endoscopic surgical system 200 or the endoscopic surgical system 300.
[0111] In an alternative embodiment, the machine 800 may operate as a stand-alone device or may be connected to other machines (e.g., may be networked). In a network deployment, the machine 800 may operate with the capabilities of a server machine, a client machine, or both, in a server-client network environment. In an example, the machine 800 may operate as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. The machine 800 can be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a cellular phone, a web appliance, a network router, a switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, although only a single machine is shown, the term "machine" shall be construed to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to implement any one or more of the methodologies as contemplated herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations, and the like.
[0112] Examples, as described herein, may include, or be operated by, logic or several components or mechanisms. A circuit set is a collection of circuits implemented in a tangible medium that includes hardware (e.g., simple circuits, gates, logic circuits, etc.). The components of a circuit set can be flexible with respect to time and the diversity of the underlying hardware. A circuit set may include components that can perform certain operations, either alone or in combination, when operating. In an example, the hardware of a circuit set can be fixedly designed to perform a particular operation (e.g., can be realized by hardware). In an example, the hardware of a circuit set includes physically changeable (e.g., magnetically, electrically, movable arrangement of massless particles, etc.) computer-readable media for encoding instructions for a particular operation, and variably connected physical elements (e.g., execution units, transistors, simple circuits, etc.). When connecting physical components, the basic electrical characteristics of the hardware components are changed, e.g., from an insulator to a conductor, or vice versa. Instructions enable embedded hardware (e.g., execution units or loading mechanisms) to create members of a circuit set in the hardware via variable connections to perform a part of a particular operation when operating. Thus, the computer-readable media is communicatively coupled to other components of the circuit set member when the device is operating. In an example, any of the physical components may be used by two or more members of two or more circuit sets. For example, during operation, an execution unit may be used by a first circuit of a first circuit set at a point in time, and may be reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set, at different times.
[0113] A machine (e.g., a computer system) 800 can include a hardware processing device 802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory device 804, and a static memory 806, some or all of which can communicate with each other via an interlink (e.g., a bus) 808. The machine 800 can further include a display unit 810 (e.g., a raster display, a vector display, a holographic display, etc.), an alphanumeric input device 812 (e.g., a keyboard), and a user interface (UI) guiding device 814 (e.g., a mouse). In an example, the display unit 810, the input device 812, and the UI guiding device 814 can be a touch screen display device. The machine 800 can additionally include a storage device (e.g., a drive unit) 816, a signal generation device 818 (e.g., a speaker), a network interface device 820, and one or more sensors 821 such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensors. The machine 800 can include an output control device 828, such as a serial (e.g., a universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection), to communicate with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).
[0114] The storage device 816 can include a machine-readable medium 822 that stores one or more sets of data structures or instructions 824 (e.g., software) that embody or are utilized by any one or more of the techniques or functions described herein. The instructions 824 may be fully or at least partially present in the main memory device 804, the static memory 806, or the hardware processing device 802 during execution thereof by the machine 800. In an example, one or any combination of the hardware processing device 802, the main memory device 804, the static memory 806, or the storage device 816 can constitute a machine-readable medium.
[0115] Although the machine-readable medium 822 is shown as a single medium, the term "machine-readable medium" can include more than one medium configured to store one or more instructions 824 (e.g., a centralized or distributed database, and / or associated cache or server).
[0116] The term "machine-readable medium" can be any medium that can store, encode, or carry instructions for execution by the machine 800, and can cause the machine 800 to perform any one or more of the techniques of this disclosure, or can store, encode, or carry data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, and magnetic media. In an example, a mass machine-readable medium includes a readable medium with a plurality of particles having an invariant (e.g., stationary) mass. Thus, a mass machine-readable medium is not a transient propagation signal. Specific examples of mass machine-readable media can include non-volatile memories such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)), and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks.
[0117] Command 824 can be transmitted or received over a communication network 826 using a transmission medium via a network interface device 820 that utilizes any one of several transfer protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Examples of communication networks include, among others, Local Area Networks (LANs), Wide Area Networks (WANs), packet data networks (e.g., the Internet), cellular phone networks (e.g., cellular networks), Plain Old Telephone Service (POTS) networks, and wireless data networks (e.g., wireless data networks), the Institute of Electrical and Electronics Engineers (IEEE) 802.11 standards group known as WiFi (registered trademark), the IEEE 802.16 standards group known as WiMax (registered trademark), the IEEE 802.15.4 standards group, and peer-to-peer (P2P) networks. In an example, the network interface device 820 can include one or more physical jacks (e.g., Ethernet jack, coaxial jack, or phone jack), or one or more antennas for connecting to the communication network 826. In an example, the network interface device 820 can include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO) technology, multiple-input multiple-output (MIMO) technology, or multiple-input single-output (MISO) technology. The term "transmission medium" is interpreted to include any intangible medium that can store, encode, or carry instructions for execution by the machine 800, and includes digital or analog communication signals or other intangible media to facilitate such software communication.
[0118] Additional Notes The foregoing detailed description includes references to the accompanying drawings that form a part of the detailed description. The drawings illustrate, by way of example, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." These examples may include elements in addition to those illustrated or described. However, the inventor has also considered examples in which only the elements illustrated or described are provided. Further, the inventor has considered examples in which any combination or permutation of the elements (or one or more aspects thereof) illustrated or described, with respect to any specific example (or one or more aspects thereof), or any other example (or one or more aspects thereof) illustrated or described herein, is used.
[0119] As used herein, the term "a" or "an," as is common in patent documents, is used to include one or more than one, independent of any other instance or use of "at least one" or "one or more." As used herein, the term "or," when not otherwise indicated, refers non-exclusively to "A or B" as including "A but not B," "B but not A," and "A and B." As used herein, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the appended 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 listed after such terms in a claim is still considered to be within that claim. Further, in the appended claims, terms such as "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.
[0120] The foregoing description is intended to be illustrative and not limiting. For example, the examples of the foregoing description (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by those skilled in the art, such as by considering the foregoing description. The abstract is provided to comply with 37 C.F.R. § 1.72(b) and to quickly confirm for the reader the essence of the disclosure of this technology. The abstract 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 simplify the disclosure. This should not be construed as intending that the disclosed features not claimed are essential to any of the claims. Rather, the subject matter of the invention may lie in less than all of the features of a particular disclosed embodiment. Accordingly, the appended claims are hereby incorporated by reference as examples or embodiments into the specification, and each claim stands on its own as a separate embodiment, and it is contemplated that such embodiments may 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 equivalent to that given in such claims.
Description of Reference Numerals
[0121] 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 optical path 120 Second output 122 Surgical site 130 Feedback signal 200 Endoscopic surgical system 210 Feedback control system 212 Feedback analyzer 214 Image analysis circuit 216 Tissue whitening detection circuit 218 Control circuit 220 Sensor 222 Imaging sensor, image sensor 224 Pressure sensor 230 Laser system 232 First laser source 234 Second laser source 240 Irrigation and / or aspiration system 250 User interface device 252 Output / display unit 254 Input unit 300 Endoscopic laser lithotripsy system 301 Endoscope 310 Feedback control system 312 Feedback analyzer 318 Control circuit 324 Illumination light source 325 Camera, imaging device 332 Laser source 334 Optical path 336 Distal end 338 Actuator 340 Irrigation and / or aspiration system 342 Perfusion fluid treatment unit 344 Irrigation and / or aspiration passage 346 Distal end 350 Illumination optical path 360 Visualization optical path 370 Illumination light 410 Endoscopic image 412 Aiming beam footprint 413 Distal tip 501 Distal end 502 Tissue 510 First pulse profile 512 Pulse of the first pulse profile 510 520 Second Pulse Profile 522 Laser Pulse of Second Pulse Profile 520 530 Predictable and Steady Turbulence 532 Bubbles Due to Evaporation 540 Unpredictable Irrigation Flow 542 Bubbles Due to Evaporation 800 Machine 802 Hardware Processing Device 804 Main Memory Device 806 Static Memory 808 Interleaving 810 Display Unit 812 Alphanumeric Input Device 814 User Interface (UI) Induction Device 816 Storage Device 818 Signal Generation Device 820 Network Interface Device 821 Sensor 822 Machine Readable Medium 824 Data Structure, Instruction 826 Communication Network 828 Output Control Device A Tissue Site, Tissue Region T Time Period
Claims
1. An endoscopic surgical system comprising: an endoscopic surgical device controllably coupled to a medical device for delivering energy to a surgical site during a procedure; an imaging sensor configured to generate an image or video frame of at least a portion of the surgical site with white light illumination present during the procedure; analyzing the generated image or video frame to determine whether a degree of heat accumulation at a first target in the surgical site exceeds a predetermined threshold; based on the determination, when the degree of heat accumulation at the first target exceeds the predetermined threshold, while avoiding damaging the first target during the procedure, determining whether to adjust at least one operating parameter associated with the endoscopic surgical system so as to achieve or maintain a therapeutic effect on a second target different from the first target in the surgical site; a control circuit configured to perform the above; and comprising: To determine whether the degree of heat accumulation at the first target in the surgical site exceeds the predetermined threshold, the control circuit detects, in the image or video frame, the speed of change over time of the intensity of one or more color components associated with the first target in the image or video frame, and determines the progression of tissue whitening at the first target based on the detected speed of change in the intensity of the one or more color components. An endoscopic surgical system configured to perform the above.
2. The first target includes tissue in the urinary system, the second target includes a target of a calculus, and the medical device comprises at least one laser system for delivering laser energy to treat the target of the calculus in the surgical site. The endoscopic surgical system according to claim 1.
3. The endoscopic surgical device is configured to direct a aiming beam from a light source towards the surgical site, and the aiming beam has characteristic color components. The control circuit is further configured to identify a footprint of the aiming beam in the generated image or video frame, and to determine a degree of heat accumulation in the first target based on an increase in an intensity of the characteristic color component in the vicinity of the footprint of the aiming beam. The endoscopic surgical system according to claim 1 or 2.
4. The control circuit is configured to determine a rate of heat accumulation in the first target based on a comparison of the images or video frames taken at different times during the procedure, and to adjust at least one operating parameter associated with the endoscopic surgical system according to the determined degree or rate of tissue whitening. The endoscopic surgical system according to any one of claims 1 to 3.
5. At least one operating parameter to be adjusted includes a laser output setting of the at least one laser system, and the control circuit is further configured to adjust the laser output setting to create a non-equilibrium irrigation flow or to promote the collapse of bubbles due to evaporation induced by the laser energy. The endoscopic surgical system according to claim 2.
6. The laser output setting to be adjusted includes a pulse sequencing representing a time distribution of laser pulses within a specific time interval, and the laser pulses are delivered to the second target according to the adjusted pulse sequencing. The endoscopic surgical system according to claim 5.
7. To adjust the laser output setting, the control circuit is further configured to prioritize adjustment of the pulse shape or pulse sequencing over adjustment of the average output of the laser pulse. The endoscopic surgical system according to claim 5.
8. The endoscopic surgical system according to any one of claims 1 to 7 further comprises an irrigation and / or suction system configured to provide irrigation fluid to the surgical site and to provide suction of fluid from the surgical site.
9. At least one operating parameter associated with the endoscopic surgical system includes at least one of an irrigation flow or a suction flow respectively associated with the irrigation system and the suction system. The endoscopic surgical system according to claim 8.
10. further comprising a pressure sensor configured to sense pressure at the surgical site during the treatment, the control circuit, when the sensed pressure exceeds the pressure upper limit, increasing the suction flow but not increasing the irrigation flow, when the sensed pressure is within the range defined by the pressure upper limit and the pressure lower limit, increasing one or both of the irrigation flow or the suction flow, when the sensed pressure drops below the pressure lower limit, increasing the irrigation flow but not increasing the suction flow, The endoscopic surgical system according to claim 9, further configured to selectively increase the irrigation flow or the suction flow via the irrigation and / or suction system, including the above.
11. further comprising an irrigation fluid treatment unit configured to change the temperature of the irrigation fluid, When the control circuit determines that the degree of heat accumulation at the first target exceeds the predetermined threshold, the control circuit is further configured to generate a control signal to the irrigation fluid treatment unit to adjust the temperature of the irrigation fluid before reaching the surgical site. The endoscopic surgical system according to claim 8.
12. The endoscopic surgical device includes an optical path with an adjustable distal portion, and the optical path is configured to direct the laser energy toward the surgical site, When the control circuit determines that the degree of heat accumulation at the first target exceeds the predetermined threshold, the control circuit is further configured to generate a control signal to an actuator coupled to the optical path to adjust the position or orientation of the distal portion of the optical path relative to the surgical site. The endoscopic surgical system according to claim 2.
13. The at least one operating parameter associated with the endoscopic surgical system is the temperature of the irrigation fluid before being applied to the surgical site, irrigation flow rate, suction flow rate, or laser output setting of the laser system, The endoscopic surgical system according to any one of claims 1 to 12, including at least one of the above.
14. The endoscopic surgical system according to claim 13, wherein the control circuit is further configured to perform the adjustment by a bias toward one of the operating parameters based at least in part on at least one of the degree of heat accumulation at the first target or the pressure at the surgical site.
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