Devices and methods for highly efficient hard and soft tissue ablation

Abstract

A system and method for use in laser lithotripsy procedures. The system may include a laser source configured to generate pulsed laser energy, an optical fiber configured to direct the pulsed laser energy to a target, and a controller. The controller is configured to receive input parameters, determine at least one procedure parameter, and calculate an N factor (Nf) corresponding to the number of laser pulses delivered to the treatment zone on the target and having a diameter approximately equal to the diameter of the laser crater generated by the pulsed laser energy. Nf is compared to a maximum N factor value (Nfmax) and used in response to the comparison to adjust the laser operating parameters or control the laser source.

Description

[Technical Field]

[0001] (Related applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 462,588, filed on 28 April 2023, entitled “DEVICE AND METHOD FOR HIGHLY EFFICIENT HARD AND SOFT TISSUE ABLATION,” the contents of which are incorporated herein by reference in their entirety.

[0002] background (Field of invention) This technical field generally relates to laser lithotripsy, and more specifically to a laser system configured to determine the optimal laser pulse parameters for a laser lithotripsy procedure. [Background technology]

[0003] Introduction Laser lithotripsy is one of the most effective and minimally invasive urological surgical procedures for treating litholithiasis, including kidney, bladder, and ureteral stones. Directed laser energy is guided from a laser source through an optical fiber to target the stones (e.g., uric acid stones, calcium oxalate monohydrate stones, cysteine ​​stones, etc.). Typically, the surgeon uses a flexible or rigid / semi-rigid scope (endoscope, ureteroscope, cystoscope, nephroscope, etc.) with a built-in camera and illumination source to guide the distal end of the fiber toward the target (stone, litholithic lesion, etc.) inside the patient's body.

[0004] To treat natural calculus lesions, the laser energy power density must exceed the ablation threshold (i.e., the ablation threshold). The ablation threshold is inversely proportional to the absorption coefficient of the calculus lesion. Therefore, Ho:YAG, Tm:YAG, and thulium pulsed fiber lasers are the most efficient in laser lithotripsy because their wavelengths (2.1, 2.01, and 1.94 μm, respectively) match the peaks in the absorption spectrum of water, which is the dominant chromophore in the near-IR wavelength range.

[0005] When the surgeon is confident that the distal end of the fiber is positioned in front of the target at an effective distance, for example, when the distance between the target and the tip of the fiber is less than 1 mm, the surgeon will turn on the laser or otherwise activate it to treat the stone.

[0006] Laser treatment is still a process involving multiple complex factors. During stone treatment, several processes can occur simultaneously or sequentially, namely: 1) the laser pulse overheats and evaporates the water in front of the distal end of the fiber, causing the evaporated bubbles to form and begin to grow at the top of the fiber tip, reaching the stone surface (the so-called "Moses effect" or "Moses channel"), 2) the laser pulse overheats and ablates the stone surface, creating a laser crater, and 3) small stone particles formed as part of the laser ablation product pass in all directions, including the direction of the fiber tip, and the laser beam... These particles are absorbed and scattered, creating a so-called "debris screening" at the bottom of the laser crater from the laser beam; 4) the water pressure wave and the jet effect of the ablated particles (so-called "backward thrust effect") cause the calculus to detach from the fiber tip; 5) calculus craters and fragmentation occur, the calculus cracks become larger and finer particles or calculus dust, the fiber tip overheats and is damaged; 6) when the laser pulse repetition rate falls below a threshold level, the bubbles collapse and the gap between the fiber tip and the target is filled with water.

[0007] The calculus ablation process and its efficiency depend on various factors (parameters) such as laser wavelength, pulse energy, peak power, pulse shape, pulse width, pulse frequency (repetition rate), average power, fiber diameter, gap between the fiber tip and the target surface, target type (calculus type / chemical composition and calculus structure / shape), fiber tip conditions, surgical instrument type (rigid, semi-rigid, flexible endoscope), instrument manipulation (movement) speed or scanning speed inside the body (depending on the surgeon and their skill and style), and many other factors (but not limited to these).

[0008] Performing operations within the body (and locations within the body) also affects process efficiency. From a safety standpoint, to avoid overheating and damaging the interior (e.g., tissues and organs), the average laser power should be extremely low, for example, inside the ureters, compared to inside the bladder or kidneys, due to the volume of free space inside each organ. If the endoscope supports the flow of water, the flow rate is also an influencing factor.

[0009] Traditionally, surgeons manually set laser parameters (pulse energy, pulse width, pulse frequency, etc.) through trial and error, based on their clinical experience, the capabilities of the selected laser system, and literature data and advice from colleagues. In many cases, the selected parameters are not optimal and fall far short of achieving high ablation efficiency. Often, there is no clear and obvious relationship between the laser settings and their effect on the ablated gallstone.

[0010] Literature data Numerous literature sources propose precise (predetermined) optimal laser parameters for different types of ablation modes (fragmentation, dusting, popcorning), and their dependence on laser type (Ho:YAG, thulium fiber laser (TFL)), calculus type (artificial begolith, COM, uric acid, etc.), organ type (environment), and fiber diameter. Figures 1A, 1B, and 1C summarize various examples from these sources, and Table 1 below lists the references for each example.

[0011] [Table 1]

[0012] For example, in the dusting ablation operating mode, the proposed laser parameters are in the range of average power 10-28W, pulse energy 0.05-0.5J, and pulse frequency 10-80Hz. Nevertheless, there are few sources explaining why these ranges of proposed laser parameters are actually optimal. Generally, the explanations are based on ablation experiments performed, regardless of the nature and / or reasons for stone ablation. Currently, there is no clear methodology proposed to determine optimal laser parameters that depend on different changing factors (situations), whether for a real-time process (during surgery) or pre-procedure.

[0013] The applicant argues that the published recommendation data is contradictory and difficult to use for the purpose of providing the best laser treatment.

[0014] In general, several efforts have been made to increase the efficiency of laser lithotripsy, particularly the efficiency of stone ablation. Non-limited examples of these efforts include the use of real-time sensory feedback (e.g., sensors for determining distance to the target, tissue type sensors, stone type and size sensors), improvements to fiber scanning with automated periodic motion, the application of specially shaped laser pulses or modulated periodic pulse sets, and the use of presets specific to certain stones and surgical areas / organs. For example, some laser systems can support specific presets with certain parameters.

[0015] Some laser systems for lithotripsy can utilize so-called smart real-time feedback systems to increase lithotripsy efficiency. For example, in Chinese patent CN110811826, titled "Intelligent Lithotripsy System," the intelligent system implements distance sensors (based on ultrasonic distance sensors, laser distance measuring devices, or structured optical distance measuring devices), temperature sensors, and pressure sensors. Furthermore, the composition, structure, color, hardness, degree of stone fragmentation, and lesion environment of the lithotripsy are automatically determined via image recognition technology through negative feedback, automatically matched with a large database, and provided surgeons with appropriate laser pulse energy, laser pulse duration, and other parameters for surgical reference. This configuration utilizes a large data platform and artificial intelligence deep learning system to propose efficient laser parameters for laser lithotripsy.

[0016] International Publication No. 2013154708, titled "Surgical Laser Systems and Laser Lithotripsy Techniques," describes a lithotripsy analyzer comprising an imager and a laser Doppler vibrometer (LDV) or laser-induced breakdown spectrometer (LIBS) to determine the characteristics of the target stone (such as the size and shape of the stone, and the composition of the target stone). The received feedback is mapped to laser energy settings (e.g., pulse repetition rate, pulse width, etc.) to generate laser energy adjusted to fragment the target stone. In some embodiments, a laser controller determines, based on the identified stone type, the laser treatment to be performed to fragment the stone.

[0017] International Publication No. 2021026161, titled "Laser Control Using a Spectrometer," describes a spectrometer-based surgical feedback control system comprising a feedback analyzer configured to receive reflected signals from a target in response to electromagnetic radiation directed at the target, and a controller capable of performing predetermined actions based on the received reflected signals, including determining the composition of the target or programming laser settings to direct laser energy towards the target. The system continuously identifies the composition of the target through the endoscope and updates the laser settings throughout the procedure. The spectrometer system collects information about the target material, which is useful for diagnostic purposes and to ensure that the laser parameters are optimal for the target. The feedback analyzer can automatically optimize the operating mode of the laser system (using an optimal setup database library), reducing the risk of human error.

[0018] The laser system controller described in International Publication No. 2021026164, titled "Endoscopic Laser Energy Delivery System and Methods of Use," can automatically program laser therapy using appropriate laser parameter settings based on the target composition, based on a machine learning algorithm trained with spectral data.

[0019] International Publication No. 2016201092, titled "Bodily Substance Detection by Evaluating Photoluminescent Response to Excitation Radiation," describes how intelligent feedback is used to detect human kidney stones and their distance by evaluating the photoluminescent radiation level response (fluorescence emission) emitted by stones excited by a low-power probe laser, in order to avoid perforating the walls of the urinary tract. This method also includes one or more parameters of the ablation energy output, which are adjusted based on the receiving parameters of the detected photoluminescent radiation.

[0020] International Publication No. 2019157406, titled "System, Method and Computer-Readable Storage Device for Controlling Laser Light Source of Lithotripsy Device," describes a laser controller system that, during the lithotripsy ablation process, selects and modifies one of the variable operating parameters of the laser source of the lithotripsy device (energy, peak power, pulse width, average power, and frequency of the laser light output from the laser source), and then determines which of several basic settings is more suitable for destroying or rupturing another layer of the lithotripsy. User assistance is still required in reaching conclusions regarding increased ablation efficiency in each specific case.

[0021] In International Publication No. 2015175151, titled "Computer-Aided Image-Based Enhanced Intracorporeal Lithotripsy," the laser system's processor is programmed to execute image processing routines and use an analysis program to determine the characteristics of the lithotripsy. The system utilizes the time-varying characteristics of a database of the current lithotripsy accumulated since the start of ablation. Using these characteristics, the processor calculates the optimal power parameters and sends them to the controller, which adjusts the power settings in response to one or more energy generation parameters.

[0022] In U.S. Patent No. 11160573, titled "Scanning Ureteroscope for Maximizing Efficiency in Laser Lithotripsy," the periodic movement of the scope's (scanning) rocker arm is coordinated by a computer with the laser pulses so that the laser energy from each pulse is directed not to one area, but to two different areas of the stone, allowing for continuous drilling. This approach results in more laser energy being spent on breaking up the stone rather than heating the water.

[0023] There is a laser system that uses a set of periodic pulses of a predetermined amplitude for “Shaped Pulsed Laser Lithotripsy” to provide a high ablation rate while minimizing the backward thrust of the ablation product, as described in the applicant’s International Publication No. 2020033121, “Method and Apparatus for Laser Lithotripsy”. The proposed preset is divided into different stages of lithotripsy: fragmentation, dusting, and popcorning, depending on the size of the lithotripsy being treated. To achieve a minimal backward thrust effect combined with high ablation efficiency, it has been proposed to use an extended pulse width or a dual pulse regime (modulation or periodic variation of pulse energy, peak power, and pulse frequency, as well as the formation of an optimal pulse shape). The pulse energy is separated so that water is evaporated and bubbles (Moses channels) are formed, and the pulse energy is used to ablate the lithotripsy. High power in the first pulse, which overheats the water and generates a force wave pressure that leads to the backward thrust of the ablation product, is not required. Once the Moses channel is overcome, the pulse power can be increased to increase the ablation rate.

[0024] One approach involves analyzing the large amount of data received during laser lithotripsy and implementing analytical approximation formulas based on that data to calculate different parameters of the procedure. For example, to increase the efficiency of lithotripsy of stones located in the upper third of the ureter, the risk coefficient for "proximal displacement" (posterior thrust of the stone or its fragments due to dilation of the ureter proximal to the stone, pressure of the irrigation fluid, and the effect of the laser on the ureteral mucosa) can be calculated, and the optimal therapeutic approach can be selected using proposed empirical formulas, such as those disclosed in Russian patent RU2725961, titled "Method of Choosing Therapeutic Approach in Laser Contact Ureterollithotripsy of Stones of Upper Third of Ureter," which are expressed as follows: Y=exp(b0+b1* X1 + b2 * X2 - b3 * X3 + b4 * X4 + b5 * (X5) / [1 + exp(b0 + b1 * X1 + b2 * X2 - b3 * X3 + b4 * X4 + b5 * X5)]、 Wherein, Y = Risk coefficient of proximal displacement, b0~b5 = Determined regression coefficients, X1 = Distance from the stone, X2 = Maximum size of the stone, X3 = Minimum size of the stone, X4 = Presence of hydronephrosis as hydrostatic dilation of the renal pelvis and calyces as a result of obstruction of urine flow downstream (0 if absent, 1 if present), X5 = Stagnation period of the stone (0 if up to 30 days, 1 if more than 30 days).

[0025] If the value of the risk coefficient Y is 30% or less, it is proposed to perform lithotripsy with a rigid ureteroscope. If the value of the risk factor Y exceeds 30%, it is proposed to perform lithotripsy with a flexible ureteroscope.

[0026] Appropriate selection of laser lithotripsy parameters enables the ability to provide safe and rapid stone removal, which, at the same time,1. Prevents thermal damage to the kidney, ureter, or bladder due to overheating of water depending on the average laser power and perfusion and outflow.

[0027] 2. Prevents perforation of the wall of the kidney, ureter, or bladder due to soft tissue ablation. The chance of perforation increases with laser pulse energy and repetition rate.

[0028] 3. Minimizes the time of laser treatment depending on the ablation efficiency and the amount of time the laser is on during treatment. This is particularly important in the case of large stones because the time of anesthesia is limited.

Summary of the Invention

[0029] The embodiments and models relate to methods and systems for use in laser lithotripsy procedures.

[0030] According to an exemplary embodiment, a system is provided for use in laser lithotripsy procedures, comprising a laser source configured to generate pulsed laser energy, an optical fiber configured to direct the pulsed laser energy to a target, and a controller coupled to the laser source, wherein the controller receives one or more input parameters, determines at least one treatment parameter, the at least one treatment parameter comprising one or more laser operating parameters, calculates an N-factor (Nf) at least partially based on the one or more treatment parameters and at least one input parameter, the Nf corresponding to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the diameter of a laser crater (Dc) generated by pulsed laser energy directed to a treatment zone on a target, compares the Nf to a maximum Nf (Nfmax), and in response to the determination that Nf is greater than Nfmax, adjusts at least one of the one or more laser operating parameters, or in response to the determination that Nf is less than or equal to Nfmax, controls the laser source using one or more laser operating parameters.

[0031] According to another exemplary embodiment, a method for performing a laser lithotripsy procedure is provided, the method comprising providing a controller which receives one or more input parameters, determines at least one procedure parameter, the at least one procedure parameter comprising one or more laser operating parameters, calculates an N factor (Nf) at least in part on the one or more procedure parameters and at least one input parameter, the Nf corresponding to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the diameter of a laser crater (Dc) generated by pulsed laser energy directed to a treatment zone on a target, compares the Nf to a maximum value Nf (Nfmax), and in response to the determination that Nf is greater than Nfmax, adjusts at least one laser operating parameter, or in response to the determination that Nf is less than or equal to Nfmax, controls a laser source using one or more laser operating parameters.

[0032] In one example, one or more laser operating parameters include pulse energy, pulse frequency, average power, peak power, and / or pulse width.

[0033] For example, when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust at least one laser operating parameter so that Nf becomes less than or equal to Nfmax.

[0034] In one example, the controller is further configured to display Nf on a display device coupled to the controller, and to output a negative alert message on the display device in response to a determination that Nf is greater than Nfmax, or to output a positive alert message on the display device in response to a determination that Nf is less than or equal to Nfmax.

[0035] In one example, one or more treatment parameters used to calculate Nf include the laser pulse frequency, laser crater diameter (Dc), and optical fiber velocity (υ). In a further example, Nf is given by the formula: Nf = (f * D c It is calculated according to ) / υ, where f(Hz) is the laser pulse frequency and D c (mm) is the laser crater diameter, and υ is the speed of the optical fiber directing the pulsed laser energy towards the treatment zone.

[0036] In one example, the laser crater diameter Dc is within the range of the following equation:

[0037]

number

[0038] In the formula, NA is the numerical aperture of the fiber, Δ (mm) is the gap between the distal tip of the fiber and the surface of the calculus, d (mm) is the core diameter of the fiber, and P peak (W) is the peak power of the laser pulse, E1(J) is the single pulse energy, and F'(J / cm² peak power of the laser pulse, and F'(J / cm²) is the peak power of the laser pulse. 2 ) is the threshold for lithotripsy.

[0039] In one example, the controller is configured to calculate Nfmax, which corresponds to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the laser crater diameter Dc, providing an average per-pulse ablation efficiency for the maximum number of pulses that is greater than or equal to a predetermined K value corresponding to the ablation efficiency achieved after a collision from a single (first) pulse.

[0040] In one example, the K value is in the range of approximately 25-75%, including both ends. In another example, the K value is in the range of approximately 25-50%, including both ends.

[0041] In one example, the controller is configured to calculate Nfmax, which is given by the formula: Nfmax = (12.4 - 3.4d) + (3.3d - 8.4) / (1 + 4.7 × 10) -5 exp(P peak / 0.0375))-((14.7d-16)+(80-65d)P peak +(55d-62)P peak 2 ) / (1+0.34E 5.5-2.6Ppeak ) is calculated according to P peak This represents peak power.

[0042] In one example, Nfmax is in the range of 1 to 12, including both ends. In another example, Nfmax is in the range of 1 to 7, including both ends. In yet another example, Nfmax is in the range of 1 to 5, including both ends. In yet another example, Nfmax is in the range of 1 to 3, including both ends.

[0043] In one example, the controller is configured to display at least one laser operating parameter on a display device based on a comparison.

[0044] In one example, the controller is configured to display at least one of Nf and Nfmax on a display device.

[0045] In one example, the system further includes at least one sensor coupled to a controller and configured to measure at least one input parameter and / or at least one treatment parameter. In a further example, the at least one sensor includes a sensor configured to measure fiber velocity.

[0046] For example, when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust at least one laser operating parameter so that Nf becomes less than or equal to Nfmax.

[0047] In one example, the controller is further configured to output a negative alert message, which includes at least one of an audible alert message, a visual alert message, and a haptic alert message, in response to a determination that Nf is greater than Nfmax, or to output a positive alert message, which includes at least one of an audible alert message, a visual alert message, and a haptic alert message, in response to a determination that Nf is less than or equal to Nfmax.

[0048] In one example, the controller is configured to output an alert message in response to a comparison, which includes at least one of an audible alert message, a visual alert message, and a haptic alert message. In a further example, the system further includes a user input device coupled to the controller, which is configured to receive input from the user, which includes at least one value of a laser operating parameter used by the controller to control the laser source. In a further example, the alert message includes information to the user regarding whether Nf is greater than Nfmax or whether Nf is less than or equal to Nfmax.

[0049] In one example, the input parameters include at least one of the target parameters, system parameters, and safety parameters. In another example, the input parameters include target parameters, which include target type, target location, and one or more target characteristics. In one example, the target is a calculus lesion, and one or more target characteristics include the size and / or hardness of the calculus lesion. In another example, the input parameters include at least one system parameter, which includes fiber diameter and / or fiber numerical aperture. In yet another example, the input parameters include at least one safety parameter, which includes maximum average power, maximum peak power, maximum pulse energy, and / or maximum pulse frequency.

[0050] In one example, the method further includes measuring at least one input parameter and / or at least one treatment parameter using at least one sensor. In a further example, the at least one input parameter includes fiber velocity.

[0051] In one example, the controller is further configured to receive input from a user input device, the input including at least one value of a laser operating parameter used by the controller to control a laser source.

[0052] According to another exemplary embodiment, a system is provided for use in laser lithotripsy procedures, the system comprising a laser source configured to generate pulsed laser energy, an optical fiber configured to direct the pulsed laser energy to a target, and a controller coupled to the laser source, the controller receiving one or more input parameters, determining at least one treatment parameter, the at least one treatment parameter comprising one or more laser operating parameters, calculating an N factor (Nf) at least in part on the one or more treatment parameters and at least one input parameter, the Nf corresponding to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the diameter of a laser crater (Dc) generated by pulsed laser energy directed to a treatment zone on a target, displaying the Nf on a display device coupled to the controller, comparing the laser operating parameters to a threshold, and adjusting at least one of the one or more laser operating parameters in response to a determination that the laser operating parameters are greater than the threshold, or controlling the laser source using the one or more laser operating parameters in response to a determination that the laser operating parameters are less than the threshold.

[0053] In one example, the laser operating parameter compared to the threshold is the pulse energy. In another example, the controller is further configured to calculate the pulse energy based at least partially on the pulse frequency. In yet another example, the controller is further configured to calculate the pulse frequency based at least partially on the maximum N factor (Nmax).

[0054] In one example, the controller is configured to adjust at least one laser operating parameter so that Nf is determined to be less than or equal to the maximum N factor Nfmax.

[0055] In one example, in response to a determination that the laser operating parameter is greater than a threshold, the controller is configured to adjust the laser operating parameter value to the maximum safe value associated with the laser operating parameter.

[0056] In one example, the controller is configured to display at least one laser operating parameter based on a comparison.

[0057] Further embodiments, forms, and advantages of these exemplary aspects and embodiments are discussed in detail below. Furthermore, it should be understood that the information described herein and the detailed description below are merely illustrative examples of various aspects and embodiments and are intended to provide an overview or framework for understanding the nature and features of the claimed aspects and embodiments. The embodiments disclosed herein may be combined with other embodiments, and references such as “one embodiment,” “one example,” “several embodiments,” “several examples,” “alternative embodiment,” “various embodiments,” “one embodiment,” “at least one embodiment,” “this embodiment and other embodiments,” and “a particular embodiment” are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described may be included in at least one embodiment. The appearance of such terms herein does not necessarily refer to the same embodiment in all cases. [Brief explanation of the drawing]

[0058] Various aspects of at least one embodiment are discussed below with reference to the accompanying drawings, which are not intended to be drawn to scale. The drawings are included to illustrate and further understand the various aspects and embodiments and are incorporated herein and constitute part of this specification, but are not intended to define any limitation to any particular embodiment. The drawings, together with the rest of this specification, are helpful in illustrating the principles and operation of the described and claimed aspects and embodiments. In the drawings, each identical or substantially identical component illustrated in various drawings is represented by similar numbers. For clarity, not all components may be labeled in all drawings. The drawings are as follows: [Figure 1A] This is a table of laser settings for lithotomy procedures, compiled from various literature sources. [Figure 1B] This is a table of laser settings for lithotomy procedures, compiled from various literature sources. [Figure 1C] This is a table of laser settings for lithotomy procedures, compiled from various literature sources. [Figure 2] This table shows typical fiber velocities for different scope types and human organ types. [Figure 3] This is a schematic diagram of the N factor as the number of pulses at a single spot / point according to various embodiments of the present invention. [Figure 4] This is a table showing the safe maximum values ​​of various laser operating parameters for different body organs according to aspects of the present invention. [Figure 5] This is a photograph of a crater array on the surface of begosite as a function of pulse energy and pulse number for different peak powers, according to an aspect of the present invention. [Figure 6] These are photographs and diagrams of the surface of a bego stone and its measured cross-sectional profile according to an embodiment of the present invention. [Figure 7] The following are multiple graphs of crater depth profiles on the surface of begosite for various pulse energies (single pulse, 500W peak power) according to aspects of the present invention. [Figure 8] A table shows the measured crater diameter after collision from a single pulse for different fiber sizes with various gaps (distance between the fiber and the calculus), pulse energy, and peak power, according to aspects of the present invention. [Figure 9] A table showing the measured saturated crater diameters after collisions from multiple pulses for different fiber sizes, as a function of gap, pulse energy, and peak power, according to aspects of the present invention. [Figure 10] This is a photograph of a groove array on the surface of a begostone as a function of average power for different fiber scanning speeds, according to an aspect of the present invention. [Figure 11] This is a table of measured specific crater volumes in scanning mode as a function of peak power, pulse energy, and N (number of pulse sequences) according to an aspect of the present invention. [Figure 12] This is a pair of tables showing a comparison between measured and calculated crater diameters after collisions from a single and multiple pulses, according to aspects of the present invention. [Figure 13] Three separate graphs, according to aspects of the present invention, show a comparison between the measured crater diameter and the calculated crater diameter as a function of pulse energy for different gaps between the begoite and the fiber tip. [Figure 14] These are three separate graphs showing a comparison between measured and calculated saturated crater diameters as a function of pulse energy for different gaps between the begoite and the fiber tip, according to aspects of the present invention. [Figure 15] Three graphs showing the calculated crater volume of a 0.2 mm fiber for different (number of pulse sequences) as a function of peak power and pulse energy, according to aspects of the present invention, are shown. [Figure 16] This is a table showing measured versus calculated values ​​of the most efficient number of pulses within a single spot for different fiber diameters, as a function of peak power and pulse energy, according to an aspect of the present invention. [Figure 17]These are three graphs showing the most efficient N-factor as a function of pulse energy and peak power for different fiber diameters, according to aspects of the present invention. [Figure 18] This is a flowchart illustrating the steps in an example of a smart assistant operation mode ("first" approach) according to an aspect of the present invention. [Figure 19] This flowchart illustrates the steps in another example of a smart assistant operating mode ("second" approach) according to an aspect of the present invention. [Figure 20] This flowchart illustrates the steps in another example of a smart assistant operating mode ("third" approach) according to an aspect of the present invention. [Figure 21] The present invention includes two screenshots from a GUI illustrating an example of a notification that can be displayed to the user on a laser system display device screen regarding the N factor, according to an aspect of the present invention. [Figure 22] This is a block diagram of a stone crushing system according to an aspect of the present invention. [Figure 23] This is a block diagram of a configuration for pulsed laser energy output according to an aspect of the present invention. [Modes for carrying out the invention]

[0059] Physical characteristics and properties of the ablation process After the formation of a Moses channel between the fiber tip and the target stone, the laser energy begins to primarily impact the stone, initiating the ablation process. The irradiation area on the stone's surface depends on the fiber output aperture and the distance to the target surface. The further away the stone is and the larger the fiber output aperture, the larger the irradiation area and the lower the laser power density on the stone's surface. However, if the ablation process is linked only to the dissociation of material within the irradiation area when the laser power density exceeds the stone's fracture threshold, the resulting crater or cavity on the stone's surface should correspond to (fit) the irradiation area, which can be calculated as follows: D=2* NA * L+d (1) During the ceremony, D is the diameter of the irradiated area on the surface of the stone. NA is the numerical aperture of a fiber. L is the distance to the surface of the stone. d is the fiber core diameter (size of the light source).

[0060] If the laser power density distribution at the fiber tip is uniform, and the laser power density remains uniform on the stone surface above the stone fracture threshold, it is reasonable to assume that the ablation crater generated on the stone will be the same as the irradiated area. If this distribution on the stone surface is non-uniform (e.g., Gaussian distribution), then the generated ablation crater should be the same as the irradiated area where the laser power density is above the stone fracture threshold. As a result, the ablation crater may be the same as or less than the irradiated area. According to some conventional reasoning, there is no obvious reason why the ablation crater could be larger than the irradiated area in either case. It is also reasonable to assume that there is no correlation between the ablation crater area and the number of irradiation pulses. An increase in the number of pulses on a single stone point can be associated with an increase in the depth of the crater and an increase in the distance between the fiber tip and the stone surface. Backward thrust impacts can also increase the distance from the fiber tip to the stone. In both cases, the result is a decrease in the laser power density on the stone surface.

[0061] However, as practice and experimentation demonstrate, the diameter of the ablation crater is usually larger than the irradiation area, even for a single laser pulse. For example, when using a pulsed thulium laser with a wavelength of 1940 nm and a peak power of 500 W, a 200 μm core fiber (less than 100 μm from the target) positioned in contact with a calculus and surrounded by water, after impact with a single 6 J pulse on the calculus surface, creates an ablation crater with a diameter of approximately 1 mm, which is five times the fiber diameter. This indicates that the nature of the ablation process is more complex than simple dissociation of the material in the laser-irradiated area.

[0062] The physical / properties of the ablation process depend on many factors, namely, laser parameters such as irradiation wavelength, mean and peak power, pulse width, energy and frequency, and laser pulse shape, also referred herein to as laser operating parameters; the equipment used (scope type, fiber diameter, fiber tip conditions, fiber movement speed, etc.); the properties of the calculus (chemical composition, structure, size, absorption, etc.); environmental characteristics (distance to the target, material in the intermediate layer between the fiber tip and the calculus surface, organ type, calculus volume, etc.); and others. These varying parameters affect the various physical processes and mechanisms of ablation, including one or more of the photomechanical, photothermal, and photochemical or photothermochemical mechanisms, as described in the applicant's International Publication No. 2020033121.

[0063] The photothermal mechanism is the absorption of radiant energy by the target material, which is converted into thermal energy. This thermal energy then generates thermomechanically induced stress in the calculus within the irradiated area and, possibly by conduction, around the irradiated area. The localized increase in temperature causes thermal expansion of the calculus material or evaporation of water trapped within the calculus, resulting in high pressure and mechanical stress that can exceed the tensile strength of the calculus. It should be noted that varying degrees of tensile strength (crystalline bonding or bridging of large domains versus small domains) can exist throughout any given calculus. The thermomechanical mechanism also begins to act when cavitation bubbles collapse near the surface of the calculus, leading to the formation of microscopic cracks and other defects within the calculus. The induced stress propagates as stress waves in and out of the irradiated zone. Such cavitation bubbles can be induced by shock waves, which are produced, in turn, by the violent collapse of large laser-induced bubbles generated via the photothermal process. Photothermochemical mechanisms relate to thermally induced changes in chemical composition that can induce dissociation of molecular bonds within the calculus bulk based on the absorption of high-energy photons, or changes in one or more mechanical properties such as changes in the absorption of laser radiation from the calculus and changes in mechanical strength. For example, thermal effects can trigger chemical reactions such as thermal decomposition within or on the mineral matrix of the calculus if organic materials are present. The former process results in direct mechanical damage to the calculus, while the latter generates cavitation bubbles that can mechanically damage nearby calculus.

[0064] These ablation mechanisms, along with an understanding of the structural and chemical composition of the calculus, suggest that, depending on the calculus's structure and chemical composition, the ablation crater can become larger than the irradiated area through stress wave propagation, thermal diffusion, and / or stress propagation.

[0065] There are three surgical techniques developed through experiments involving the mechanisms described. The fragmentation mode technique utilizes lower frequency pulses at higher peak laser power, applied to a small area of ​​the stone over a relatively long time period. This technique results in a relatively deep, large-area pore with macrocracks generated by photothermal and subsequent thermomechanical stress. The dusting (scanning, dancing) mode technique utilizes a fiber that moves continuously across the stone surface during the delivery of higher frequency laser pulses. This technique ablates a thin layer of the stone along the path the laser traverses. Finally, the so-called popcorning mode technique utilizes a stationary fiber directed to a cluster of stones and fragments generated by repeated laser firing. Each laser pulse induces the expansion and collapse of bubbles in the surrounding water, which in turn produces a fluid flow within a confined volume, such as that found in the renal calyces of the kidney or the bladder. Each specific surgical technique may be efficient for one type of stone but less efficient for another. In other words, there is no universal, general-purpose laser mode that is applicable to all types of kidney stones and environments.

[0066] For a given type of fiber, it can be inferred that the greater the laser impact (power density) applied to the calculus, the larger the size of the ablation crater. However, this is not entirely true because it ignores other outcomes of the ablation process. According to one publication [Boris Majaron et al., "Debris screening and heat diffusion in Er:YAG drilling of hard dental tissues," Proc. SPIE 2973, Lasers in Dentistry III, (15 May 1997)], the dependence of the depth and volume of ablation craters on the applied laser fluence while human dentin and enamel are exposed to Er:YAG laser pulses shows a nonlinear quasi-logarithmic dependence. The process of laser drilling of calculus in lithotomy may be similar to the process in human dentin and therefore should also exhibit such nonlinearity. Debris screening nonlinearity is complex and has multiple origins. Debris ejection and the ablation effect on the stones may interfere with the current laser pulse if they are long enough, but may not interfere with the next laser pulse if the pulse frequency is low enough. On the other hand, debris adhesion to the fiber tip can be permanent and persistent throughout the entire procedure unless the fiber is cut.

[0067] When the incident laser fluence of a single pulse at a given spot exceeds the threshold for stone fracture, the depth and volume of the ablation crater initially increase with increasing laser fluence (energy density). However, further increases in laser fluence beyond a certain fluence level do not lead to further crater growth, and therefore additional laser energy is wasted. This fluence level can be determined and occurs due to so-called "debris screening," which is the screening (coating) of the fiber tip with ejected debris particles from the stone. This (very hot) debris is ejected in all possible directions, and any portion directed toward the tip may adhere to the tip or, at the very least, be in the path of the laser during emission, partially interfering with energy delivery to the stone surface by scattering or absorbing radiation. The debris formation process is nonlinear, and the imbalance becomes more pronounced when greater laser energy is applied. Therefore, an unbalanced decrease in the ablation rate can be expected with increasing laser power density (or fluence).

[0068] Furthermore, if debris adheres to the fiber tip, the debris will continue to absorb laser energy and transfer heat to the fiber. The fiber tip may be thermally damaged, which can then directly absorb laser energy, leading to further fiber tip damage. At this point, most of the applied laser energy is blocked from striking the stone, and the clinician must remove the fiber from the endoscope and initiate the cutting of the fiber tip.

[0069] In summary, despite the harmful effects of backward thrust, higher pulse energies can be ineffective and even harmful. On the other hand, pulse energies that are too low can reduce the size of the ablation crater, prolong the procedure, or, in the worst case, fall below the ablation threshold. Therefore, the most efficient pulse energy for a given peak power lies somewhere between these two limits. Thus, it is important to have a deeper understanding and quantification of the ablation process so that an optimal range of laser parameters can be found to optimize ablation efficiency and, therefore, increase the safety and effectiveness of lithotomy surgical procedures.

[0070] Ablation rate and ablation efficiency The efficiency of the calculus ablation process has been shown to vary under factors related to laser parameters, environmental characteristics, and target type. The potential efficacy of the ablation process can be characterized by the ablation rate and ablation efficiency.

[0071] Ablation rate (A R mm 3 A) is the rate of volume removal or dissociation of the target. Ablation rate quantifies how quickly the target can be ablated and removed. In other words, A R On average, this is how much volume (mm³) is absorbed per unit exposure time (e.g., 1 second). 3 This quantifies whether the substance is deleted / removed. The ablation rate can be expressed as follows:

[0072] A R =V / t (2) Here, V(mm 3) is the target volume, and t(s) is the time of complete target laser irradiation for destruction / dissociation / removal. In other words, the ablation rate indicates how quickly a current target with a given volume can be destroyed, which affects the laser oscillation time and the operation (treatment) time. As explained above, the ablation rate is expected to be a function of the laser parameter settings, and the objective is to minimize this metric for a given treatment.

[0073] The ablation threshold, the ablation process, and the competing adverse effects of screening, posterior thrust, and tip damage all depend on the power density, which is proportional to the energy-to-time ratio for a given fiber type and environment. This means that additional metrics need to be introduced to properly characterize the ablation process in lithotomy. Ablation rate is an important metric for determining the treatment time for a given stone size, but it is even more important to minimize the total laser energy required for a given treatment and stone. For example, there are situations where applying extra pulse energy does not lead to an increase in ablation rate. For instance, at the same power density, 3J may have the same ablation rate as 6J. At lower power densities, a 3J energy pulse may provide a higher ablation rate than 6J. This can happen due to the competing effects discussed above, and possibly other effects. If the same ablation rate can be achieved with lower pulse energy (energy efficiency), there is no prudent reason to apply additional energy.

[0074] Ablation efficiency (A E mm 3 / J) is the volume of calculus (mm³) that is removed / eliminated by applying laser energy to the target. 3This is the amount of the applied laser pulse energy. This reflects the efficiency of the applied laser pulse energy. For example, the ablation efficiency of a single laser pulse is the volume of the resulting crater / cavity divided by the pulse energy. For multiple pulses applied to a single target point, the ablation efficiency is the final crater volume divided by the total applied energy, which is the sum of the energies of each applied pulse. The average ablation efficiency can be expressed as follows:

[0075] A E =V / Σ(E) (3) Here, Σ(E)(J) is the total laser energy applied, and Σ(E) = E1 + E2 + ... + E n (n = number of pulse sequences or number of pulses). The energy of each pulse is the same E for all j. j If =E, then Σ(E j )=N * E is the number of pulses, where N is the number of pulses.

[0076] In other words, ablation efficiency reveals the target volume that can be removed by applying a specific unit of laser energy (e.g., 1 joule).

[0077] When applied to lithotomy procedures in which a fiber can be moved relative to the stone, the ablation efficiency can be expressed as follows:

[0078]

number

[0079] In the formula, S(mm 2 ) is the vertical cross-sectional area of ​​the laser-generated crater after scanning, and υ (mm / sec) is the relative velocity of the fiber to the stone.

[0080]

number

[0081] This is the average laser power. In certain situations, the reciprocal of the ablation efficiency (1 / A) is used. E , J / mm 3 It should be noted that this can also be called ablation efficiency. In this case, the reciprocal indicates how much energy should be expended to ablate a unit target volume (e.g., 1 cubic millimeter).

[0082] It is important to evaluate the ablation efficiency during the procedure. If the ablation efficiency is known and the stone volume V is known, the laser oscillation time T of the procedure can be evaluated using the following formula.

[0083]

number

[0084] Considering equation (3), the laser oscillation time can also be expressed as follows:

[0085]

number

[0086] Equation (5) shows that increasing ablation efficiency reduces laser oscillation time and therefore the procedure time, which is important for treating large stones and completing the procedure within the anesthesia time. To achieve this, it is first necessary to understand that ablation efficiency depends, for example, on what the target material is, and that things can be done to increase ablation efficiency.

[0087] Ablation efficiency depends on many factors, including laser wavelength, pulse energy, pulse frequency, pulse width, pulse shape, average and peak power, laser power density, fiber diameter, energy distribution within the fiber, numerical aperture of the fiber, condition and shape of the fiber tip, distance to the target, target type (stone type / chemical composition and stone structure / shape), target absorption, type of surgical instrument (rigid, semi-rigid, flexible endoscope) and speed of instrument manipulation (movement), clinician skill, and other factors.

[0088] For illustrative purposes, the ablation efficiency of a fiber located in contact with a calculus will be higher than that of a fiber located 1-2 mm away from the calculus, all other factors being equal, because less laser is absorbed by the medium (water) in the gap between the fiber tip and the calculus, and, in some cases, because of a higher power density on the ablated calculus surface (a smaller laser spot size due to laser beam divergence can increase the ablation rate). In addition, a fiber with a larger diameter and aperture located at the same distance from the calculus may have a lower ablation efficiency, all other factors being equal, because it delivers a lower power density to the calculus surface and therefore has a lower ablation efficiency, depending on the level of power density relative to the ablation threshold. Therefore, to perform lithotomy more efficiently, it is important to carefully select the appropriate power, energy, and fiber type and to control the distance to the target.

[0089] As discussed above with reference to perforation of human dentin, it is expected that a similar nonlinearity of ablation efficiency may apply to multiple pulses delivered to the same point on a calculus. The ablation efficiency of multiple consecutive pulses to a single point or spot on a target calculus is lower than that of the first pulse to that point or spot. The crater created by the first (or previous) pulse increases the distance from the fiber to the calculus surface (bottom of the crater), and therefore reduces the incident power density and fluence of the next (subsequent) pulse. The laser radiation of the subsequent pulse will be attenuated due to many factors described above, including, but not limited to, the longer distance between the distal end of the fiber tip and the laser target, attenuation due to ablation through deeper, water-filled craters, and other factors, which provide greater opportunities for attenuation due to scattering and absorption by the ablation products. Thus, the number of pulses hitting a single target spot on a calculus and its effect on ablation efficiency depend on both the pulse frequency and the fiber velocity. The higher the fiber velocity, the fewer pulses will hit a given target point. In conventional procedures, urologists select only three laser parameters for treatment: laser energy, repetition rate, and pulse width (or peak power). These selections control / determine the average laser power, which is crucial for preventing overheating and damage to surrounding soft tissue. Conventional understanding dictates that energy should be selected within a range that provides acceptable levels of ablation efficiency, backward thrust, and visibility per pulse. Frequency (repetition rate) f is important for preventing thermal damage to soft tissue from overheating, and average power P=E * f is selected to be as high as possible, up to the maximum fmax, while maintaining f at the safe level Pmax. However, this approach to increasing the repetition rate is not effective in maximizing ablation efficiency and / or minimizing treatment time, due to the mechanism mentioned above, which degrades ablation efficiency between multiple pulses on the same point on the target. For this reason, the applicant proposes a new parameter, the N factor, to be considered for laser lithotripsy.

[0090] N factor During laser lithotripsy, the clinician directs the laser pulse towards the stone and moves the scope tube with the fiber positioned in front of the stone (dusting mode). The speed at which the fiber is moved depends on the clinician, the type of scope, and the organ being treated. For example, Figure 2 shows a table illustrating typical fiber movement speeds for different scopes and organ types.

[0091] Fiber velocity and pulse frequency are parameters that determine the number of pulses for a spot on the target, and this is equal to the crater diameter D. c This is determined. Therefore, the fiber velocity and pulse frequency determine the ablation efficiency. For the purposes of this disclosure, the number of pulses hitting one target point or spot is the "N factor" (=N f ) is called N f This can be expressed as follows: Nf=(f * D c ) / υ (7) During the ceremony, f(Hz) is the laser pulse frequency (repetition rate), D c (mm) is the laser crater diameter, υ(mm / s) is the velocity of the fiber relative to a point on the stone (i.e., the relative velocity of the distal tip of the fiber moving in a direction parallel to the stone surface).

[0092] Increasing the pulse frequency directly leads to an increase in the N factor. Increasing the pulse energy in the current peak power (applied to a single target point) can result in an increase in the crater diameter, and therefore, unless there is the nonlinearity in ablation efficiency mentioned earlier, it can increase the N factor. As another example, the crater diameter also depends on the distance to the target surface, and therefore, the closer the fiber is to the target stone, the smaller the crater diameter will be, and thus a smaller N factor will result. In addition, increasing the fiber velocity υ leads to a lower N factor.

[0093] The visualization of the N factor can be represented as shown in the schematic diagram in Figure 3. As shown in Figure 3, according to a particular embodiment, Nf can be considered to correspond to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the diameter of the laser crater (Dc) formed by pulsed laser energy directed to the treatment zone on the target (e.g., a lithic lesion). For example, as shown in Figure 3, Nf=2 means that the fiber scans the target surface (e.g., during dusting) and any point within this scan is exposed to two consecutive laser pulses. In other words, the scanning region received a total of two laser pulses at all points along the scan. Similarly, N f =4 means that the fiber scans the target surface so that each spot in the scan is exposed to four consecutive laser pulses.

[0094] Considering equations (4) and (7), the ablation efficiency can be expressed in terms of Nf as follows:

[0095]

number

[0096] S * D c is, N f It is proportional to the crater volume after the cumulative effect of the pulses, and therefore S = S(N f ) and D c =D c (N f Please note that the maximum ablation efficiency is N. f Despite the increase in multi-shot crater volume associated with the increase in N, the crater size does not increase proportionally, therefore the first pulse delivered to the treatment spot, N fThis corresponds to =1. For example, the crater size after two pulses is less than twice the crater size after a single pulse. Therefore, the ablation efficiency decreases with each subsequent laser pulse. Nevertheless, dusting ablation techniques assume that the fiber is scanning in a continuous groove formation, not the fabrication of separate perforations / holes / craters.

[0097] As shown below, in reality, the ablation crater diameter is N f As increases, it will asymptotically "saturate" or reach a constant value. This means that at some point, additional pulses (increases in the N factor) will not increase the diameter and depth, and therefore the volume, of the crater. The ablation efficiency of each pulse after saturation begins is zero, and therefore the total ablation efficiency begins to decrease rapidly.

[0098] The N-factor value provides, on the one hand, continuous target scanning / grooving, and on the other hand, sufficient ablation efficiency for each subsequent laser pulse. In practice, one might ask, "What purpose does additional exposure to the current target spot with additional pulses serve if it does not result in visible / valuable ablation?" This point is emphasized by the idea that the desirable objective is to minimize the energy accumulated in the body as much as possible. In certain embodiments, it is better to target / move the fiber to a new spot / position so as not to waste energy and time simply heating the water in the surrounding area. Therefore, simply increasing the pulse energy and / or pulse frequency is not the optimal way to increase ablation efficiency, as is sometimes the case with conventional approaches taken by many physicians (and can even be harmful).

[0099] Another aspect of implementing the N factor is to adopt the most efficient laser parameters or set of laser parameters (which provide maximum ablation efficiency with minimum energy) at the physician's typical moving speed. While fiber speed is an poorly controlled parameter that depends entirely on the clinician's skill, the N factor is still effective. fFurthermore, it is also a continuously changing factor. In addition, a laser configured in smart assistant mode (implemented by the controller) can use feedback to control laser parameters (e.g., pulse energy, pulse frequency, average power, pulse width, peak power, etc.) (in real time or by preset) to maintain efficient treatment.

[0100] Generally, higher pulse energy results in larger crater size and a greater fiber velocity that the physician can use to provide efficient ablation. Alternatively, physicians may use lower pulse frequencies, which have a similar effect on the N factor and ablation efficiency as an increase in fiber velocity (N). f =fD c (v). On the other hand, if physicians tend to use low fiber velocities, the pulse energy and / or pulse frequency should also be limited to effectively suit the physician's style of ablation process (A E =Sv / (E p f).

[0101] There are also important aspects of N-factor limits related to the basic safety of the procedure. To avoid overheating and damage to organs, there are basic upper limits (or ranges), referred to herein as safety parameters, for applicable laser operating parameters such as pulse energy and average power, based on safety considerations. These safety parameter limits (or ranges) are organ type dependent. Figure 4 is a table showing the limits of various safety parameters for different organs. Using equation (7), the N-factor can be considered to depend at least in part on both pulse energy and pulse frequency, which depend on the aforementioned safety considerations that must first be examined and permitted before implementing any laser operating parameter preset.

[0102] Despite the fact that laser lithotripsy offers numerous advantages over other optimal methods for removing stones, such as mechanical and acoustic / ultrasonic methods, various issues and challenges still need to be addressed, including increasing procedure safety, reducing procedure time, and maximizing procedure efficiency. Many of the factors described above directly influence these challenges and need to be considered together.

[0103] Therefore, it is highly valuable to have an intelligent laser system (so-called smart assistant mode) that can automatically calculate, determine, and propose the optimal set or range of laser parameters (pulse energy, frequency, peak power, pulse width, etc.) for laser lithotripsy in real time. Such an algorithm depends on at least some of the physical properties / nature of the ablation process and related variable factors (fiber diameter, average power, organ type, endoscope type, physician's typical fiber velocity, etc.) to increase the efficiency of the procedure and reduce the procedure time. The specific objective in this case is an algorithm that adjusts the laser parameters to continuously optimize the N factor (e.g., ensuring that Nf is less than or equal to Nfmax), as will be explained in more detail below.

[0104] Experiments, methods, and measurements In various embodiments, an implemented smart assistant mode is provided to help the physician select the most efficient and precise laser mode (i.e., set of laser parameters) for ablating the current target (e.g., calculus or soft tissue). As used herein, such treatment is calculus lesion or calculus (hard tissue) treatment, and as used herein, the term "calculus lesion" refers to calculus lesions (calculus) located in anatomical locations such as the ureter, kidney, or bladder. Calculus lesions include all types of calculus in the body of a human or animal. However, it should be understood that similar methods can also be applied to the ablation, cutting, incision, and ablation of soft tissue. The selection of which laser mode to use should be done in real time before or during the procedure. To achieve this, it is necessary to characterize the ablation efficiency and procedure of calculus, and to understand what the ablation efficiency depends on, and therefore which factors are most important for increasing the ablation efficiency.

[0105] As mentioned above, ablation efficiency depends on many dynamic and static variables / parameters / factors. Despite the fact that some of these variables are static or not precisely controlled (e.g., fiber movement speed, fiber size), other available parameters (e.g., laser settings such as pulse energy, pulse frequency, peak and average power) can be precisely controlled in real time during the procedure.

[0106] The key is to understand the relationships between these different classes of factors and how they affect ablation efficiency. This understanding is crucial for implementing the optimal smart assistant mode.

[0107] There are several methods for determining these relationships. The first approach is to study theoretical models (scientific theories) of the processes that occur during laser ablation of stones / tissue and to identify and define variables based on these theoretical models. However, it is frequently found that the predictions of theoretical models may differ from actual measurements because there are important factors / variables that are not included in the theoretical models. Nevertheless, even if the precise representation is known and the theoretical model is incomplete, analytical approximations can provide a sufficiently accurate solution to the problem while greatly reducing its complexity.

[0108] The second approach involves performing heuristic analytical approximation, which includes conducting a comprehensive experimental program that incorporates controllable and uncontrollable factors during the procedure, providing appropriate measurements, analysis of results, and development of an analytical approximation model of the ongoing ablation process that predicts experimental results to a certain level of accuracy. Using this model, the ongoing ablation process can be computed and predicted, and thus appropriate laser parameter settings can be selected to provide maximum ablation efficiency in clinical cases.

[0109] As an example of this approach, the applicant identified and characterized parameters relevant to improving the safety and efficiency of surgical procedures for laser lithotripsy and soft tissue manipulation, introduced an analytical model for laser oscillation time and procedure length depending on laser parameters and N-factor-dependent ablation efficiency, and derived equations (5) and (8) above. As the next step in such a program, the applicant performed a wide-ranging and comprehensive series of in vitro experiments of laser ablation in scanning mode on the stone surface, as discussed below, the data of which provided for the determination of the optimal N-factor and then defined the most efficient use of the laser for a given clinical procedure.

[0110] In these experiments, Bego stones were used as target stones. These stones are composed of a special type of hard gypsum and are generally recognized in the industry as a good model of urinary phantom stones. The Bego stones had dimensions of approximately 60 × 40 × 5 mm, a flat and even surface, and were placed in water in a cuvette. The stone surface level was controlled by a leveling tool. A factory-cut surgical fiber tip was directed onto the stone surface at a right angle and a predetermined, precisely controlled distance (gap). A thulium fiber laser was used to generate directed optical pulse energy. An electric precision linear two-axis stage was used to move the fiber to a new location after each impact (perforation or scanning) of the laser pulse, forming an array of laser-treated sites. Scanning of the fiber parallel to the stone surface at an adjustable constant speed was controlled by an electric XY linear stage. The primary objective of the experimental program was to identify and quantify the laser-generated craters as a function of the laser parameters in the stone model.

[0111] A crater matrix / array is formed on the surface of the calculus, and each crater is generated by specific laser parameters, the extent of which is defined below.

[0112] 1. The surgical fibers used had core diameters ranging from 0.2 to 0.94 mm.

[0113] 2. The distance between the fiber tip and the surface of the calculus ranged from 0.1 (near-contact) to 1 mm.

[0114] 3. The pulse energy was in the range of 0.1 to 6 J.

[0115] 4. Peak power was in the range of 250-2000W.

[0116] 5.1 The number of pulses (N factor) at point 5.1 ranged from 1 to 20 per crater (pc).

[0117] Figure 5 shows the peak power (P) of 500, 750, and 1000W. peakThe following are photographs of examples of crater arrays on the surface of Begoite after laser pulse impact, as functions of pulse energy (E) and N factor (Nf) (all using a 200 μm fiber and a 0.1 mm gap between the fiber and the Begoite surface).

[0118] After drying the begoite (waiting 24 hours at 25°C before measurement), all crater diameters and cross-sections were measured using an optical profilometer (Zygo NewView® 8300), as illustrated in the figure shown in Figure 6. The cross-section of each crater has a "U-shape," as shown in the graph results shown in Figure 7 (and also seen in Figure 6), which shows the "U-shaped" depth profile of different craters as a function of pulse energy (single pulse, 500W peak power). Crater diameters were determined from digitized images using sampling at 886 points (pc) per crater. The size and shape of the craters (diameter, depth, cross-section, volume) are related to, or otherwise function of, the laser pulse parameters (pulse energy, N factor, peak power) and other conditions (fiber diameter and gap, etc.).

[0119] Figure 8 is a table of crater diameters formed by a single laser pulse. The results show that crater diameter increases with increasing pulse energy or peak power, respectively, due to increases in total laser fluence or laser fluence rate (power density). Similarly, crater diameter increases with increasing fiber diameter for higher power but not for lower power, because lower power pulses are closer to the threshold power density, making the beam profile more important. As the gap increases, the trend becomes more complex due to interactions between the laser, lithotripsy, and water resulting from Moses channel dynamics.

[0120] The crater diameter begins to saturate when the N factor value is in the range of 10-20, depending on other pulse parameters. This means that the rate of increase in crater diameter with additional laser pulses decreases significantly. Figure 9 shows the results for 10-20 pulses (Nf The results for saturated crater diameter after 10-20 pulses are shown. The data indicate that the "saturated" (maximum) crater diameter exhibits a similar trend to that shown by the diameter of a single-pulse crater with fluctuating pulse energy and peak power for a given fiber diameter and gap. However, the value of the saturated crater diameter is not even twice that of the single-pulse crater.

[0121] The scanning / groove matrix / array depends on variable / changing parameters. The experiment utilized factors within the following range (note that the distance between the distal tip of the fiber and the stone surface was kept constant at 0.5 mm for all data points).

[0122] 1. The surgical fibers had core diameters ranging from 0.2 to 0.94 mm.

[0123] 2. The pulse energy was in the range of 0.2 to 6 J.

[0124] 3. Peak power was in the range of 250-1000W.

[0125] 4. The average power consumption was in the range of 10-40W.

[0126] 5. The pulse frequency was in the range of 5 to 55 Hz.

[0127] 6. The fiber scanning speed was constant for each scan and was within the range of 0.5 to 10 mm / s.

[0128] 7. The Nf and N factors were in the range of 1 to 20. Each scan was unique to itself. As an example, Figure 10 shows the average power for fiber scanning speeds of 0.5, 1.25, and 2 mm / s (200 μm fiber, 500 W peak power, 0.8 J pulse energy, 0.5 mm gap between the fiber and the Begosite surface).

[0129]

number

[0130] As a function of N, the image shows a photograph of the groove array on the surface of the Begoite after impact with scanning laser pulses. Thus, the range of the number of shots per point across the grooves in this figure is N. f This is 4-64 shots per spot.

[0131] The total number of data points collected for measuring scanning depth and cross-section was 88 pc (per crater). The depth and cross-section of each scan were measured using the same optical profilometer.

[0132] After the scanning experiment, the area of ​​the ablation crater cross-section in the vertical plane (S, mm) 2 ) Different laser parameters, namely pulse energy (E, J), average power

[0133]

number

[0134] The pulse frequency (f, Hz) and fiber scanning speed (υ, mm / s) were measured.

[0135] Figure 11 is a table showing the results of groove measurements after impact from scanning pulses, and shows the calculated specific crater (groove) volume (volume contribution of individual pulses) in scanning mode for a 0.2 mm fiber core diameter as a function of peak power, pulse energy, and N (number of pulse sequences). Specific crater (groove) volume (mm 3 ) is calculated according to the following formula: V=(S * υ) / f (9) During the ceremony, S(mm 2 ) = Area of ​​the crater (groove) cross-section, υ(mm / s) = fiber scanning speed (constant during each scan), and f(1 / s) = pulse frequency.

[0136] Calculation, approximation, and consideration To explain the relationship between crater diameters at a single point after the first laser pulse (FP), an analytical formula with adjustable coefficients was fitted to the experimental data. The result is given by the following formula:

[0137]

number

[0138] During the ceremony, NA = Numerical Aperture of Fiber Δ(mm) = Gap between the fiber tip and the surface of the calculus. d(mm) = fiber core diameter, P peak (W) = peak power of the laser pulse. E1(J) = Single pulse energy, F'(J / cm 2 For the Begoite model at a wavelength of 1.94 μm, the radiation level is 20 J / cm². 2 This is the threshold for target stone disruption (threshold ablation).

[0139] Equation (10) is an analytical approximation that depends on physical factors. For example, the factor (2NAΔ+d) is the diameter of the irradiation spot on the target as a function of the distance to the target, Δ, the fiber diameter (core) d, and the numerical aperture NA. Factor E1 / (0.25π(2NAΔ+d)) 2 ) is J / cm 2 It can be described in units of and reflects the energy fluence (energy density) on the target surface. Dividing this factor by F' yields a partial excess of energy / fluence that exceeds the ablation threshold. The remaining formula / value is a total correction factor with small physical significance.

[0140] Equation (10) is not the only possible expression to approximate, explain, or otherwise reveal the crater diameter behavior as a function of the variable of interest. While many other analytical approximations can be found based on experimental data, the solutions for crater diameter should be equal to each other, regardless of which equation is used, since they must all fit / predict the same experimental data.

[0141] Figure 12 is a pair of tables showing a comparison of experimental and calculated data using the proposed equation (10) for crater diameter after collisions from single and multiple pulses for a 200 μm fiber and a 0.5 mm gap, as a function of pulse energy and peak power. Figure 13 shows an example of the application of equation (10) (solid line in the graph in Figure 13), reflecting a graph showing a comparison between measured experimental data and calculated data (via the proposed equation 10) for gaps of 0.1 mm, 0.5 mm, and 1 mm, and for a 0.2 mm fiber and a peak power of 500 W. The shape of the curves indicates that the relationship between crater diameter and pulse energy is logarithmic. The error of the proposed equation (10) (i.e., the difference between measured and calculated data divided by the average of measured and calculated data) is within 30% for all energies.

[0142] To explain the existing relationship between saturated crater diameters after multiple laser pulses (Nf=10~20), another analytical approximation formula was found.

[0143]

number

[0144] Again, equation (11) is not the only possible equation that can predict the saturated crater diameter as a function of the dependent variable. Many other analytical approximations can be found and fitted to experimental data, but all approximations should yield experimental crater diameters.

[0145] According to at least one embodiment, the crater diameter Dc It lies within the range of equation (10) and equation (11), according to the following formulas: D c FP ≤D c ≤D c SAT or

[0146]

number

[0147] In the expressions, the variables are defined above for those expressions.

[0148] Figure 14 shows three graphs in which the saturated crater diameter can be obtained using the application of equation (11), reflecting a comparison between measured experimental data and calculated data (equation (11)) for 0.2 mm fiber and 500 W peak power for gaps of 0.1 mm, 0.5 mm, and 1 mm. Similar to Figure 13, the shape of the curves shows that the relationship between crater diameter and pulse energy is also logarithmic. The error of the proposed equation (11) (i.e., the difference between measured and calculated data divided by the average of measured and calculated data) is within 30% for all pulse energies.

[0149] Figure 15 shows different N values ​​as a function of peak power and pulse energy. f Three graphs show the calculated specific crater volume for a 0.2 mm fiber against the (number of pulse sequences) value. The gap between the fiber tip and the calculus is 0.5 mm. The points (data points) reflect experimental data points, and the lines reflect the curves of the calculated data approximation. The error is less than 30%.

[0150] Figure 16 is a table comparing the most efficient measured and calculated pulse counts at a single spot for different fiber diameters, as a function of peak power and pulse energy. The error is less than 30%.

[0151] As described above, increasing the pulse frequency while using the same pulse energy and increasing Nf (the number of pulses to one spot) does not necessarily lead to an increase in ablation efficiency or the overall efficiency of the treatment. Starting from the "exact moment", it is clear that each additional irradiation pulse on the same target spot does not necessarily result in efficient ablation of the target volume. According to various aspects, new parameters, namely, the most efficient number of pulses within one spot, or Nf that satisfies the following formula max can be named and utilized: A E (Nf max ) / A E (Nf = 1)=K (12) Here, A E (Nf max ) is the average ablation efficiency per pulse after Nfmax pulses in a single spot, and A E (Nf = 1) is the ablation efficiency of the first pulse to the spot, which is the ablation efficiency per pulse at the maximum possible (or the ablation efficiency of a single pulse). The K value is a predetermined value, and according to some embodiments, it can be selected to be in the range of about 0.25 to 0.75 (25 to 75%) (including both ends), more preferably in the range of about 0.50 to 0.75 (50 to 75%). In some embodiments, the K value is in the range of about 25 to 75% including both ends, and in some embodiments, the K value is in the range of about 25 to 50% including both ends. A higher K value provides higher ablation efficiency and shorter treatment time. According to at least one embodiment, Nfmax is in the range of 1 to 12 including both ends. In another embodiment, Nfmax is in the range of 1 to 7 including both ends. In yet another embodiment, Nfmax is in the range of 1 to 5 including both ends, and in yet another embodiment, Nfmax is in the range of 1 to 3 including both ends.

[0152] Equation (12) is for Nf maxHowever, this means that it is determined to be the exact number of pulses within a single spot that provides an ablation efficiency of K or greater than the maximum possible ablation efficiency or the ablation efficiency of a single pulse. In some embodiments, Nfmax corresponds to the number of laser pulses delivered to a treatment zone having a diameter approximately equal to the laser crater diameter Dc, providing an average ablation efficiency per pulse for a maximum number of pulses of a predetermined K or greater than the ablation efficiency achieved after collision from a single (first) pulse. In other words, all current spots on the target are irradiated by the minimum number of most efficient pulses. In one embodiment, when the ablation efficiency of an additional pulse is reduced to a value less than the maximum possible ablation efficiency or from the ablation efficiency of a single pulse to K, it is not meaningful to irradiate the current spot with an additional laser pulse, and it is far more efficient to move the fiber to a new target spot during target scanning (dusting technique). In other embodiments, the same applies to K values ​​of 0.25 or greater, 0.50 or greater, or 0.75 or greater than the maximum value.

[0153] Since the ablation efficiency and the ablated volume are related by equation (3), Nf max It can also be found by using the specific crater volume.

[0154] V(Nf max ) / [Nf max * V(Nf=1)]=K (13) Equation (13) is Nf maxHowever, this means that it can be determined as the exact number of pulses within a single spot that provides a per-pulse stone volume ablation of at least 1 / K of the maximum possible ablation volume generated by the collision of the first pulse. In other words, every spot on the target is irradiated by the minimum number of most efficient pulses. The example in equation (13) provides a per-pulse stone ablation volume of at least K of the maximum possible (first pulse) ablation volume, but other percentage values, including K=0.25, K=0.50, and up to K=0.75 of the maximum possible first pulse ablation volume, are also within the scope of this disclosure. If the ablation volume of the additional pulses is reduced to 25, 50, 70, or 75% of the maximum possible first pulse ablation volume, there is no reason to irradiate this current spot with additional laser pulses, and it is far more efficient to move the fiber into the new target spot during target scanning.

[0155] According to at least one embodiment, Nf is compared to Nfmax. This can be done by the controller, as discussed in more detail below. In response to a determination that Nf is less than or equal to Nfmax, the laser source is controlled using one or more laser operating parameters used to calculate Nf in order to control the laser source during the laser lithotripsy procedure. In response to a determination that Nf is greater than Nfmax, the controller (or user) can adjust at least one laser operating parameter used to control the laser during the lithotripsy procedure. In this case, the objective is to adjust the laser operating parameter so that the Nf value is less than or equal to Nfmax. This approach is discussed in more detail below. In addition, the controller may be configured to display at least one laser operating parameter on a display device based on the comparison, and in some cases, at least one of Nf and Nfmax may be displayed on the display device.

[0156] According to at least one embodiment, Nf is selected to be less than or equal to Nfmax or otherwise adjusted. In some embodiments, this is done by adjusting one or more laser operating parameters such as pulse energy, pulse frequency, average power, peak power, and / or pulse width. As described above, Nfmax corresponds to the number of laser pulses delivered to the tissue surface at a particular spot within the treatment zone, and all pulses at that spot ablate a volume of calculus (increasing the diameter / depth / volume of the crater formed from the previous pulse), and in some embodiments, at least 25% of the ablation efficiency achieved with the first (single) pulse, in some embodiments, at least 50%, and in still other embodiments, at least 75% of the average calculus ablation efficiency per pulse. In one embodiment, the 75% criterion is calculated according to Equation (14) described below.

[0157] This approach is shown in the three graphs of FIG. 17, where the Nfmax (solid line) determined for each fiber diameter (0.2, 0.55, and 0.94 mm) for a peak power of 0.5 kW can be seen. The graphs show the most efficient N factor as a function of pulse energy and peak power for different fiber diameters using a gap of 0.5 mm between the fiber and the calculus surface. The data points reflect the measured experimental data, and the solid line curves show the data calculated using an analytical approximation. For example, for a fiber diameter of 0.2 mm with a peak power of 0.5 kW and a pulse energy of 6 J, the maximum ablation volume (ablation volume for a single pulse) is V(Nf = 1) = 0.37 mm 3 is. Using Equation (13), (V(Nf<( max ) / (Nfmax * V(Nf = 1)) = 0.7 = 0.7 * 0.37 mm 3 = 0.26 mm 3The calculation was performed. The corresponding number of pulses for Nfmax=12, which corresponds to the calculated ablation efficiency value, is found by interpolating the volume between Nfmax=10 and 12 in the table in Figure 11. This value represents the maximum number of pulses in a single spot that has an acceptablely high ablation efficiency per pulse.

[0158] Figure 16 also shows this approach having the most efficient number of pulses at a single spot for different fiber diameters (0.2, 0.55, and 0.94 mm) as a function of peak power (0.25–1 kW) and pulse energy (0.2–6 J).

[0159] Using the Nfmax measurement data from the table in Figure 11, another approximation formula was determined that describes the dependence of the highest efficiency N factor on other factors, namely, the fiber lithotripsy gap d, peak power, and pulse energy E and K = 0.75.

[0160] Nfmax=(12.4-3.4d)+(3.3d-8.4) / (1+4.7×10 -5 exp(P peak / 0.0375))- ((14.7d-16)+(80-65d)P peak +(55d-62)P peak 2 ) / (1+0.34E 5.5-2.6(Ppeak) ) (14) Since the number of pulses is a natural number, the result of equation (14) must be rounded to the nearest integer. Equation (14) is also not the only possible equation that describes the most efficient N-factor behavior as a function of the variables. It is only one of several possible approximations that describe this relationship. Therefore, many other possible analytical approximations can be found based on the experimental data obtained, but the most efficient solution to the N-factor equation must predict the experimental data from Figure 11.

[0161] According to various embodiments, Nfmax is determined based on a database of stored Nf data obtained from experiments (e.g., the data behind Figure 11). Preclinical and clinical trial data from laser lithotripsy procedures are analyzed, and Nfmax values ​​are calculated for different combinations of input and procedure parameters to determine the most efficient number of pulses within a single spot, and in accordance with safety parameter thresholds to avoid encountering tissue damage or other adverse effects.

[0162] Returning to Figure 17, the three graphs show examples of the application of equation (14) and a comparison between measured experimental data and data calculated via the proposed equation for peak powers of 250W, 500W, and 1000W using a 0.5mm gap, for 0.2mm, 0.55mm, and 0.94mm fibers. The data calculated using this proposed equation is also shown in the table in Figure 16. The accuracy of the proposed equation (14) (i.e., the difference between the measured and calculated data divided by the average of the measured and calculated data) is within 30% for all pulse energies.

[0163] Based on the data from Equation 14, Table 16, and Figure 17, Nfmax may be in the range of 3 to 12. Nfmax increases with energy and peak power. This defines that the optimal value of Nfmax is 12 or less, preferably 7 or less, more preferably 5 or less, and most preferably 3 or less. According to various embodiments, during treatment, Nf may be less than the value within the above interval.

[0164] The most efficient pulse number Nf max It is clear that Nf increases with increasing peak power. For a given power, max It begins to grow and eventually saturates with increasing pulse energy. For example, when increasing the pulse energy from 0.2 J to 3 J for a 0.55 μm fiber and a peak power of 1 kW, Nf max It increases from 4 to 10, but even if the pulse energy is further increased to 6J, Nf maxIt does not increase any further. The proposed equations (10), (11), and (14) are sufficient for an algorithm that provides pulse energy and frequency for optimized treatment (maximum efficiency with minimum energy) for lithotripsy, taking into account the explained changing factors (e.g., fiber diameter, gap, peak power).

[0165] Proposed smart assistant mode approach According to various embodiments, there are several ways to implement the smart assistant mode and its possible integration into a laser system. For the purposes of this disclosure, three non-limiting examples are considered: a first example as process 1800 in Figure 18, a second example as process 1900 in Figure 19, and a third example as process 2000 in Figure 20. However, it should be understood that other modifications to the approach are also within the scope of this disclosure. In addition, equations (10), (11), and (14) can be used in other non-limiting approaches and applications of the smart assistant mode during laser lithotripsy. One or more steps included in these processes may be performed by a controller 150 or components of the controller, which are discussed in more detail below with respect to system 100 in Figure 22.

[0166] At the outset of all proposed approaches, the first step (1802, 1902, 2002) includes receiving or otherwise acquiring one or more input parameters. According to various embodiments, the one or more input parameters include at least one of target parameters, system parameters, and safety parameters. The controller 150 may be configured to receive one or more input parameters.

[0167] In some embodiments, one or more input parameters comprise target parameters, such as information about the target and target location. Target parameters may include target type (e.g., lithic lesion), target location (e.g., kidney, bladder, ureter), and / or one or more target characteristics. For example, according to one embodiment where the target is a lithic lesion, one or more target characteristics may include the size and hardness of the lithic lesion. In addition, according to another embodiment where the target is a lithic lesion, one or more target parameters may include proposed ablation techniques such as fragmentation, dusting, or popcorning. These latter parameters may be based in part on one or more target characteristics, such as the size and hardness of the lithic lesion.

[0168] According to at least one embodiment, one or more input parameters include system parameters such as laser type, laser characteristics, and other information relating to the system performing the procedure. Non-limiting examples of system parameters include laser type, e.g., thulium fiber laser (TFL), Ho:YAG, Tm:YAG solid-state laser and / or laser wavelength, fiber diameter (i.e., the diameter of the optical fiber (e.g., optical fiber 110 in Figure 22, also referred to herein as a surgical fiber) that directs the laser energy toward the target), and instrument type such as flexible, rigid, and / or semi-rigid scopes.

[0169] According to at least one embodiment, one or more input parameters include safety parameters, including a maximum laser operating parameter, to ensure that the patient being treated is not exposed to unnecessary damage. In some embodiments, the safety parameters include at least one of the following: maximum average power, maximum peak power, maximum pulse energy, and / or maximum pulse frequency. In some embodiments, the safety parameters also include a minimum pulse energy.

[0170] Input parameters may be received or otherwise determined by the controller 150 in several different ways. For example, a user 120 (e.g., a physician) may input one or more input parameters to the system 100 via a user input device 135 (e.g., a touchscreen). In one embodiment, the physician 120 inputs at least one target parameter (e.g., target location, and, if the target is a litholithic lesion, target size and hardness). In some cases, target size and hardness may be determined by visually inspecting the target beforehand using an imaging device. In another embodiment, the user 120 (physician) inputs input parameters to the system (e.g., via a user input device 135 such as a touchscreen) that include one or more system parameters such as fiber diameter and / or fiber numerical aperture. In another embodiment, the user 120 (physician) inputs input parameters that include one or more safety parameters such as maximum average power, maximum pulse energy, and / or maximum peak power. In some embodiments, the user 120 may input one or more safety parameters, such as maximum average power and maximum pulse energy, at least in part based on safety considerations, using (e.g.) the table in Figure 4. In other embodiments, the controller 150 itself may be configured to determine one or more safety parameters based at least partially on one or more other input parameters (e.g., target type, target characteristics, target location, fiber size, and / or instrument type). For example, information stored by the controller 150 (e.g., a table including information from Figure 4) may be used at least partially by the controller 150 to determine one or more safety parameters based on one or more other input parameters.

[0171] According to another embodiment, the controller 150 calculates and / or uses the stored input parameters. For example, in one embodiment, the user 120 selects one or more proposed (predetermined) input parameter values ​​(using a user input device 135, such as a GUI touchscreen, for example), and the controller 150 calculates the maximum average power and safe energy range (E) based on other input parameters such as the organ to be treated (e.g., kidney, ureter, bladder), the type of instrument (rigid, semi-rigid, flexible), the fiber diameter, and the required ablation technique (fragmentation, dusting, popcorning). min -E max It automatically determines input parameters such as ).

[0172] In some embodiments, the fiber diameter can also be automatically determined by the controller 150 by using, for example, a built-in NFC or RFID chip associated with a surgical fiber instrument (e.g., an endoscope) (e.g., a sensor such as sensor 125 in Figure 22).

[0173] In some embodiments, one or more treatment parameters (also referred to herein as therapeutic parameters), such as laser operating parameters, can be automatically determined (calculated) by the controller 150. For example, peak power can be automatically determined by the controller 150 based on the potential / capacitance / characteristics of the laser source 105 and the safety parameters used in the treatment.

[0174] Three examples of laser systems that utilize the N factor as a treatment parameter, depending on the specific configuration, are described below. In addition, other treatment parameters such as pulse energy, frequency, pulse width (or peak power), and average power are used to provide maximum ablation efficiency and minimum treatment time. For example, one or two users (a urologist or their assistant) may use the N factor within an optimal range. <N fmax Select treatment parameters to maintain the optimal range. Example 3 of the laser system uses real-time measurement of fiber velocity and the N factor to set the optimal range ≤ N. fmaxThis includes automatic adjustment of laser parameters to maintain them.

[0175] First example of a laser system with a smart assistant mode Figure 18 shows a flowchart of an example of steps used in a first approach using the smart assistant mode or in process 1800. As previously stated, one or more of the steps included in process 1800 may be performed by a controller (e.g., controller 150, which is discussed below). The first step in 1802 includes receiving one or more input parameters (e.g., by the controller), as described above. According to at least one embodiment, the input parameters include target parameters. In one embodiment, the target parameters include a target type, a target location, and one or more target characteristics. In some embodiments, the target type is a calculus lesion and the target location is the kidney, bladder, or ureter. In certain embodiments, the target type is a calculus lesion and one or more target characteristics include the size and / or hardness of the calculus lesion. In some embodiments, the input parameters include at least one system parameter, and in one embodiment, at least one system parameter includes at least one of fiber diameter, fiber numerical aperture, and instrument type. For example, as shown in Figure 22, the optical fiber 110 is used to direct pulsed laser energy, and the fiber diameter and optical aperture are related to the distal end of the optical fiber 110 (the end from which the pulsed laser energy is emitted). In some embodiments, the instrument type is flexible or rigid scope type. In other embodiments, the input parameters include at least one safety parameter, and in one embodiment, at least one safety parameter includes maximum average power, maximum peak power, maximum pulse energy, and / or maximum pulse frequency.

[0176] According to another embodiment, at least one procedure parameter (also referred to herein as a process parameter) is determined. The procedure parameter may include one or more parameters used by the physician and / or system or otherwise implemented when performing a lithotomy procedure. Non-limiting examples of procedure parameters include pulse frequency, peak power, pulse energy, laser crater diameter, fiber velocity, gap between the fiber tip and the target, and target ablation threshold. According to a particular embodiment, the N factor Nf or maximum N factor Nfmax may also be considered a procedure parameter and / or laser operating parameter.

[0177] In some embodiments, at least one procedure parameter to be determined includes fiber velocity (υ). This can be done automatically by the controller 150 using the table in Figure 2, based on one or more previously received parameters (e.g., input parameters such as organ type, instrument type, fiber diameter, etc.). Alternatively, the physician can input the fiber velocity they need or intend to use. Another approach is for the physician to select a proposed relative regime / style of fiber manipulation (e.g., slow, average, or fast) that they need or intend to use, and the laser system automatically determines the corresponding fiber velocity (minimum, typical, maximum) using the proposed data, for example, as shown in the table in Figure 2. The fiber movement velocities in Figure 2 were determined based on the processing of endoscopic video captured during calculus laser treatment performed by several different urologists. Specific values ​​in this table can be averaged across different urologists or collected for a specific user and stored in the controller for Nfmax calculation. In other embodiments, the physician can predefine the fiber velocity.

[0178] According to some embodiments, the mean safe pulse energy is calculated based on one or more safety parameters or determined otherwise. For example, in step 1806, the mean safe pulse energy

[0179]

number

[0180] It is calculated according to the following formula, based on the maximum pulse energy Emax and the minimum pulse energy Emin (for example, the minimum pulse energy required to perform ablation).

[0181]

number

[0182] Emin can be determined from memory data obtained from previous preclinical and / or clinical trial data and corresponds to the minimum pulse energy that provides minimally acceptable efficiency (i.e., an acceptable amount of ablation to the target stone lesion).

[0183] In some embodiments, at least one treatment parameter to be determined is the crater diameter Dc. For example, in step 1808, the controller 150 uses the proposed formula (10) or (11) to determine the crater diameter (D c The system can be configured to calculate the following: Since the crater diameter is a function of the gap (Δ), another procedure parameter that can be determined is the gap between the fiber and the target. This can be determined by the controller 150 and, in some examples, can be considered the typical average gap for fiber lithotripsy (e.g., 0.5 mm), and is therefore a value stored in memory (e.g., memory 140 in Figure 22) by the controller 150. Alternatively, the physician 120 can input the gap they need or intend to use (e.g., via the user interface device 135). The crater diameter is also a function of the target threshold (F'). This is the average typical threshold of the target stone during lithotripsy or the threshold of the Bego stone (e.g., 20 J / cm²). 2) can be accepted by the controller 150 or otherwise determined. Alternatively, the physician 120 can input a target threshold that he requests or intends to use during treatment. Another approach may be that the physician selects the type of stone (target and target properties) (e.g., target properties such as uric acid, cysteine, calcium oxalate monohydrate (COM), struvite, xanthine, silicate, mixed / combined type stones) at the start of treatment, inputs this information as an input parameter (via the user interface device 135), and the controller 150 determines the stone threshold using a pre-set / predetermined value (e.g., previously acquired / measured threshold data for each stone type stored in memory 140).

[0184] In another embodiment, the maximum N factor (Nfmax, also referred to herein as Nmax) is calculated or otherwise determined, and Nfmax may be considered to be the most efficient number of pulses, as discussed earlier. In process 1800, Nfmax is determined in step 1810 (e.g., by controller 150) using equation (14).

[0185] In some embodiments, treatment parameters such as pulse frequency are calculated, which may be based at least in part on Nfmax. For example, in process 1800, the pulse frequency (f) is calculated in step 1812 using equation (7).

[0186] f=(Nf max * D c ) / υ (15) According to another embodiment, treatment parameters such as pulse energy are calculated. In some embodiments, pulse energy is calculated at least in part based on the pulse frequency (e.g., by controller 150). For example, in step 1816 of process 1800, pulse energy (E) is calculated using the following formula:

[0187]

number

[0188] In the next step 1816, the safety of the calculated parameters is checked. For example, treatment parameters such as pulse energy E may be compared (e.g., by controller 150) with a threshold (e.g., Emax) corresponding to the safety parameter value.

[0189] In a further embodiment, if the calculated pulse energy E is less than or equal to the threshold Emax, a second comparison calculation may be performed in step 1822 (e.g., by the controller 150). For example, the calculated pulse energy E is less than or equal to the mean safe pulse energy calculated in step 1806.

[0190]

number

[0191] The calculated pulse energy E can be compared to the second threshold.

[0192]

number

[0193] Rather than a predetermined amount (for example, 20%)

[0194]

number

[0195] When only large, in some embodiments, the process returns to step 1808 and uses the calculated pulse energy (calculated at step 1814 using equation (16)) to determine the crater diameter Dc using the proposed equation (10) or (11) (e.g., by controller 150), and the process continues from step 1808. If the calculated pulse energy E is a predetermined amount (e.g., 20%) less than the second threshold

[0196] [Number]

[0197] If the following, controller 150 displays one or more of the treatment parameters (such as laser operating parameters (e.g., pulse energy, power, and frequency)), whether already calculated or calculated at this step, on display device 130. This is shown in step 1824 of process 1800.

[0198] When returning to step 1816, if the calculated pulse energy is greater than the threshold or exceeds the threshold (E>E max ), controller 150 sets the pulse energy E as the maximum pulse energy (safe pulse energy value) Emax in step 1818, and then in step 1820, the pulse frequency is recalculated using equation (16) (e.g., by controller 150). With the pulse frequency recalculated, controller 150 displays one or more of the processing parameters (e.g., laser operating parameters such as pulse energy, pulse frequency, average power, peak power) on display device 130 (e.g., step 1824 discussed above).

[0199] In some embodiments, if the pulse energy E is less than or equal to a threshold (e.g., Emax), the controller 150 outputs a positive alert message on the display device 130. An example of such a positive alert message 157 is shown on the left side of Figure 21 (i.e., "You are currently using the optimal parameters"). In alternative embodiments, if the pulse energy E is greater than a threshold (e.g., Emax), the controller 150 outputs a negative alert message 159 on the display device 130. An example of such a negative alert message is shown on the right side of Figure 21 (i.e., "You are currently deviating from the optimal parameters").

[0200] According to at least one embodiment, the final step of the process is for the user 120 to approve the displayed treatment parameters from step 1824. For example, a physician may approve the calculated parameters in step 1826 (e.g., by interacting with the user input device 135 and / or by initiating the treatment). The treatment is then initiated using these displayed treatment parameters.

[0201] Second example of a laser system with a smart assistant mode Figure 19 shows a flowchart of the steps illustrating an example of a second approach using Smart Assistant Mode 1900. The first step in 1902 is similar to step 1802 discussed above with reference to process 1800 in Figure 18, and includes receiving one or more input parameters (e.g., by the controller) as described earlier.

[0202] According to another embodiment, at least one treatment parameter is determined. For example, a second step 1904 of process 1900 includes determining at least one treatment parameter, such as determining the fiber velocity (υ), in a manner similar to that described above with reference to step 1804 of the first approach method 1800.

[0203] The next step is split into two parallel processes / actions.

[0204] The first parallel process / action begins in step 1906 with the physician inputting a pulse energy E(E) that falls within the safety range (e.g., the safety range is based on the input safety parameters) that he wishes to use (via the user input device 135). In some cases, this step may be performed by the controller 150 based on one or more input parameters. Another procedure parameter that may be calculated includes the crater diameter Dc, which is done in step 1908 using the proposed equations (10) or (11). In some embodiments, the crater diameter Dc in step 1908 may be at least partially based on the input pulse energy E introduced in step 1906. This step may be performed by the controller 150. The fiber gap (Δ) and target threshold (F') may be input as constant values ​​in step 1908 in a manner similar to that described above. The next step 1910 is to calculate the pulse frequency (f) using equation (16), which is done by the controller 150. Subsequently, in step 1912, the number of pulses, i.e., the N factor (Nf), is calculated using equation (7) (this can also be done by the controller 150).

[0205] The second parallel process / operation is performed in a manner similar to that described above with reference to step 1806 of process 1800, within the received safe energy range

[0206]

number

[0207] The process begins in step 1914, where the mean safe energy is calculated using (which can also be calculated by the controller 150 or determined otherwise). In step 1916, treatment parameters such as the crater diameter Dc are calculated (e.g., by the controller 150) using the proposed equation (10) or (11), as described above with reference to step 1808 of process 1800. The fiber gap (Δ) and target threshold (F') can be entered here as constant values ​​in a similar manner to that described above.

[0208] The next step, 1918, is to calculate the maximum N factor Nfmax, i.e., the most efficient pulse number (e.g., by the controller 150), using equation (14) in a manner similar to that described above with reference to step 1810 of process 1800. Treatment parameters such as pulse frequency (f) are calculated in step 1920 using equation (15) in a manner similar to that described above with reference to step 1812 of process 1800. Then, other treatment parameters such as pulse energy E using equation (16) are calculated in step 1922 in a manner similar to that described above with reference to step 1814 of process 1800.

[0209] In step 1924, a safety check similar to that in step 1816 of process 1800 is performed on the calculated parameters. For example, treatment parameters such as pulse energy E are compared by controller 150 to a threshold (Emax). If the calculated pulse energy is greater than or otherwise exceeds the threshold, controller 150 sets (adjusts) the pulse energy E to the maximum pulse energy Emax (E=Emax) in step 1926, and the pulse frequency is recalculated in step 1928 (for example, using equation (16)) in a similar manner to that described above with reference to steps 1818 and 1820 of process 1800. In process 1900, after step 1928, the process returns to step 1918 and calculates the maximum N factor using equation (14) due to the changed energy and frequency parameters (E=Emax in step 1926, which triggers the pulse frequency change in step 1928). If the calculated pulse energy E does not exceed the upper limit of the safety range (E≦E max ), the second parallel process / operation terminates.

[0210] The next step in process 1900, 1930, is to compare Nf with Nfmax. For example, the Nf calculation performed in step 1912 is compared with the Nfmax value calculated in step 1918. It should be recalled that the crater diameter Dc value calculated in step 1908, which is used to calculate Nf in step 1912, may itself depend on the pulse energy value entered by the physician in step 1906. Although this comparison of Nf and Nfmax is explicitly shown in Figure 19, it should be understood that this step may be included in all approaches considered herein.

[0211] If Nf is greater than Nfmax, in step 1934, the controller 150 provides feedback, for example, via a positive or negative alert message, to inform the physician that they are currently outside the optimal laser parameters. This can be implemented using one of several different methods, such as (but not limited to) outputting a corresponding warning (notification) on the screen (visual notification) in combination with the current Nf value. Figure 21 shows two different screens (GUI screenshots) of the output to the user 120 on the display device 130. The screenshot on the right is an example of a negative alert message 159 (i.e., you are currently outside the optimal parameters) indicating to the user 120 that Nf 155 (value 17) is greater than Nfmax and the optimal treatment parameters (i.e., laser operating parameters) have not been calculated. Suboptimal treatment parameters may also be displayed to the user 120 on the display device 130. If Nf is less than or equal to Nfmax, in step 1932, the controller 150 provides positive feedback to the user 120. For example, the screenshot on the left of Figure 21 is an example of a positive alert message indicating to the user that the N factor 155 (value of 5) is less than Nfmax and that the optimal treatment parameters, including the laser operating parameters, have been calculated (i.e., you are currently using the optimal parameters). The optimal treatment parameters may also be displayed to the user 120 on the display device 130.

[0212] According to some embodiments, in response to a determination that Nf is greater than Nfmax, at least one laser operating parameter may be adjusted, as illustrated in step 1924, the pulse energy set to the maximum safe value, and then fed back into the process to calculate a new Nfmax value. In some embodiments, in response to a determination that Nf is less than or equal to Nfmax, the laser source may be controlled using the laser operating parameter.

[0213] Although not explicitly shown in process 1900, before the physician approval step at 1936, the controller 150 may display on the display device 130 one or more of the treatment parameters (such as laser operation parameters (e.g., pulse energy, power, and frequency), whether already calculated or calculated at this step) in a similar manner as described above with reference to step 1824 of process 1800.

[0214] It should be understood that in addition to the positive or negative alert messages 157 and 159 shown in FIG. 21, other visual signals, and / or audio signals (voice notifications), and / or tactile notifications may be provided simultaneously as possible feedback.

[0215] The last step 1936 is for the physician (or the physician's assistant) 120 to approve the desired parameters in a similar manner as described above with reference to step 1826 of process 1800. The user 120 here needs to choose whether to still use sub-optimal laser parameters and perform a less efficient treatment, or here, to choose to accept the proposed calculated (and most efficient) laser parameters. Alternatively, the operator can still choose to change the laser parameters (e.g., pulse energy and / or frequency) for which the condition of Nf≦Nf max still applies.

[0216] A Third Example of a Laser System with Smart Assistant Mode A flowchart showing the steps in a third exemplary approach method 2000 using the smart assistant mode is shown in FIG. 20. According to a particular aspect, this approach is considered to be a more accurate and effective method because it assumes the implementation of a real-time feedback system and one or more laser sensors 125 (e.g., fiber speed, current fiber distance to the target, current stone type and / or structure recognition, e.g., sensor 125 of FIG. 22).

[0217] The first step in 2002 is similar to step 1802 discussed above with reference to process 1800 in Figure 18, and includes receiving one or more input parameters (e.g., by the controller), as described earlier. Step 2004 is the calculation of the average safety energy based on the received safety energy range.

[0218]

number

[0219] This includes the calculation and is similar to step 1806 described later in process 1800.

[0220] The next step is divided into three parallel processes / actions.

[0221] The first parallel process / operation is the acquisition of current fiber velocity data (υ) in step 2006. This can be achieved using different methods such as relative fiber velocity calculation based on so-called real-time visual image computer processing (e.g., processing images including the treatment zone and the fiber (distal tip)), an internal fiber velocity sensor such as an accelerometer, or other techniques. For example, sensor 125 in Figure 22 may include a sensor configured as a fiber velocity sensor, i.e., a sensor configured to measure fiber velocity. If a fiber velocity sensor is not present in the lithotomy system, this current approach can still be used by inputting the fiber velocity as a constant value in this step, in a manner similar to that described above with reference to step 1804 of process 1800 and step 1904 of process 1900.

[0222] The second parallel process / operation in step 2008 involves acquiring data from a distance sensor (e.g., sensor 125 in Figure 22 may include a distance sensor) that measures the current gap between the fiber tip and the target surface. This can be achieved by different possible methods such as relative target size calculation based on the relationship between the target size and the fiber diameter (e.g., so-called real-time visual image computer processing as mentioned above), back reflection / scattering sensors, ultrasonic sensors, etc. If a fiber distance sensor is not present in the lithotripsy system, this current approach can still be used by inputting a constant value for the fiber gap in this step, in a manner similar to that described above in processes 1800 and 1900.

[0223] A third parallel process / operation in step 2010 involves acquiring data on the type and / or structure of the calculus currently located in front of the fiber. This can be achieved using different techniques such as (but not limited to) back-reflection / scattering sensors, fluorescence sensors, vision sensors, or other techniques / sensors (e.g., sensor 125 in Figure 22).

[0224] According to at least one embodiment, the data (treatment parameters) collected in steps 2006, 2008, and / or 2010 are received by the controller 150.

[0225] Procedure parameters such as the ablation threshold F' for the calculus lesion or calculus can be calculated in 2012 (e.g., by the controller 150). This can be achieved by the controller 150 based on the target input parameter, using pre-set values ​​stored in memory 140 (e.g., previously obtained / measured threshold data for each calculus type). In some embodiments, if a calculus type and / or structure sensor is not present in the lithotomy system, this current approach can still be used by inputting the target threshold as a constant value in this step, in a manner similar to that described above with reference to processes 1800 and 1900.

[0226] This step (involving three parallel processes) ends when all currently required sensor data regarding the treatment parameters and / or target parameters has been acquired for all parallel data acquisition processes / operations.

[0227] The next step in 2014 is to check whether the acquired sensor data differs from previously collected data. One or more treatment parameters (e.g., fiber velocity, distance between the fiber tip and the target, target characteristics) are compared by the controller 150 to stored treatment parameters. Essentially, the system checks whether any changes have occurred since the last automated laser parameter setting calculation. In some embodiments, step 2014 may be optional, such as at the start of the process. Step 2014 may be important because, in some embodiments, the fiber movement velocity and / or characteristics such as the gap between the fiber tip and the stone may change during treatment, and these values ​​need to be rechecked.

[0228] If the fiber is moving at the same constant velocity (υ), the target is the same calculus with the same threshold (F'), and it is located at the same distance (Δ), then none of the previous laser parameter settings (if any) need to be changed. Therefore, if, in step 2014, the acquired sensor data related to one or more treatment parameters is the same as (or there is no previously collected data yet), then the next step in 2016 is to use the proposed equation (10) or (11) to determine the crater diameter (D c The process involves calculating at least one treatment parameter, such as ). Otherwise, i.e., if the acquired data (fiber velocity, distance between the fiber tip and the target) and / or target characteristics (ablation threshold) differ from those previously collected, the process returns to the step of acquiring new real-time sensor data (2006, 2008, 2010).

[0229] In the next step 2018, Nfmax is calculated using equation (14), followed by the calculation of the pulse frequency (f) using equation (15) in step 2020, and then the calculation of the pulse energy (E) using equation (16) in step 2030. Each of these steps is similar to steps 1810, 1812, and 1814 described earlier in process 1800, and can be performed by the controller 150.

[0230] In step 2032, a safety check of the calculated parameters is performed in a manner similar to that described above with reference to step 1816 of process 1800. Also, as described above with reference to process 1800, a positive or negative alert message may be displayed on the display device as a result of comparing the pulse energy (or Nf) with a threshold (Emax or Nfmax).

[0231] If the calculated pulse energy is less than or equal to the threshold (E ≤ E max), in step 2036, a second comparison calculation is performed in a manner similar to that described above with reference to step 1822 of process 1800. For example, if the calculated pulse E is greater than the second threshold by a predetermined amount, in some embodiments, the process returns to step 2016 and determines the crater diameter (e.g., by the controller 150) in a manner similar to returning to step 1808 of process 1800 as described above. If the calculated pulse energy E is less than or equal to the second threshold, the controller 150 displays one or more treatment parameters (whether already calculated or calculated in this step), such as laser operating parameters (e.g., pulse energy, pulse frequency, average power), on the display device 130 in step 2040. These laser operating parameters may be considered proposed or “current” laser operating parameters, and according to at least one embodiment, the controller 150 may use these laser operating parameters to control the laser source 105. Therefore, process 2000 skips the "physician approval" step 1826 of process 1800 and step 1936 of process 1900.

[0232] Returning to step 2032, if the calculated pulse energy E is greater than the threshold (Emax), i.e., E > Emax, then in step 2034, the controller 150 sets the pulse energy E as the maximum pulse energy (safe pulse energy value) Emax in a manner similar to that described above with reference to step 1818 of process 1800, and then in step 2038, the pulse frequency is recalculated (e.g., by the controller 150) using equation (16) (similar to step 1820 of process 1800). Once recalculated, the controller 150 displays one or more process parameters (e.g., laser operating parameters such as pulse energy, pulse frequency, average power, etc.) on the display device 130, and then controls the laser source 105 using these laser operating parameters (e.g., step 2040 discussed above).

[0233] The final step of this process is to return to the steps of acquiring data from the sensor (steps 2006, 2008, 2010) until it is determined in step 2042 that the lithotomy procedure is complete. In a particular embodiment, user 120 may determine that the process is complete when the lithotripsy lesion is no longer visible in the scope image sensor, and / or controller 150 may determine that the procedure is complete when no lithotripsy material is detected in the volume of interest (kidney, ureter, bladder). The entire process is periodic and consists of real-time sensor data acquisition and real-time calculation and setting of the most efficient current laser parameters based on the acquired data.

[0234] The faster the sensor 125 can operate (measure and communicate), the faster the laser parameters can adapt to real-time changing process parameters (e.g., fiber speed, gap, stone type / structure), making lithotomy procedures more efficient.

[0235] General System Description Figure 22 is a block diagram of one non-limiting example of a laser system (also referred to herein as a lithotripsy system), generally shown as 100, provided by at least one embodiment for use in lithotripsy procedures. According to various embodiments, system 100 can operate in smart assistant operating mode according to the flowchart described in Figures 18, 19, and 20. System 100 has a controller 150 coupled to a display device 130 and a user input device 135.

[0236] The display device 130 is configured to display information (output) to the user 120 (e.g., a physician), and the user input device 135 is configured to receive information (input) (e.g., one or more input parameters) from the user 120. In some embodiments, the display device 130 and the user input device 135 may be integrated into a single device. For example, a graphical user interface (GUI) may be displayed to the user 120 on a touchscreen to display information (e.g., N factor) to the user and to receive information from the user 120 (via the touchscreen). The controller 150 is coupled to the display device 130 and is configured to display information such as treatment parameters, laser operating parameters, Nf, and / or Nfmax on the display device 130.

[0237] The user input device 135 is configured to receive input from a user 120, such as a physician, and can take any one of several different forms, including a touchscreen. Other non-limiting examples of user input devices, besides a touch-sensitive screen, include a cursor control device (CCD) such as a mouse, trackball, or joystick, a keyboard, one or more buttons, switches, or knobs, and a voice input system. In some embodiments, the input from the user constitutes user input data that can be used (at least partially) by a controller 150 to control one or more components of the system 100, such as a laser source 105.

[0238] User input data may include initial user input data received from user 120 at the start of the procedure. In some embodiments, the initial user input data includes input parameters, which include at least one of (1) one or more characteristics of the laser lithotripsy system, (2) one or more characteristics of the target, and (3) one or more safety parameters.

[0239] According to at least one embodiment, system 100 also includes a laser source 105 configured to generate pulsed laser energy. Non-limiting examples of the laser source 105 include a thulium-doped fiber laser (TFL), an erbium-doped fiber laser, a yttrium-doped fiber laser, a Ho:YAG solid-state laser, a Tm:YAG solid-state laser, or a Nd:YAG solid-state laser. Although not explicitly shown in Figure 22, either the controller 150 or the processing laser 110 itself includes a driver for the laser source. According to one embodiment, pulsed laser energy is generated using an energy storage device 109, as shown in the configuration shown in Figure 23. In this configuration, system 100 includes a power supply 103, a laser driver 107, a pump 111, and an energy storage device 109 (e.g., an electric capacitor and / or inductor). The pump 111 consists of one or more diode lasers that provide laser radiation to the laser source 105. Power supply 103 provides power to the system, and energy storage device 109 is configured to store a sufficient amount of energy to form laser pulses. The laser driver 107 of pump 111 forms electrical pulses of specified characteristics in response to control signals from controller 150. The electrical pulses are received by one or more diodes of pump 111, which form optical pulses necessary to pump the laser medium of laser source 105.

[0240] In alternative embodiments, pulsed laser energy can be generated via any one of several techniques, including laser modulators (e.g., AOM, EOM, EAM), Q-switching, mode-locking, cavity damping, and / or gain-switching.

[0241] Returning to Figure 22, according to at least one embodiment, the system 100 also includes an optical fiber 110 configured to direct pulsed laser energy towards a target 115. The pulsed laser energy is output as a laser beam 112 and may be used to treat any one of several urinary conditions in the target. According to some embodiments, the optical fiber 110 may be configured as a component of a lithotripsy device. A lithotripsy device (e.g., a cystoscope, a sheathed / unsheathed flexible endoscope (percutaneous nephrolithotomy, PCNL) / rigid endoscope, a mini / ultramini PCNL endoscope)) may include other related support components such as a fluid flow device (e.g., irrigation and suction functionality), one or more optical systems, a reflective device, an articulated arm, and / or a mechanical or robotic device configured to assist in performing the lithotripsy procedure.

[0242] The controller 150 is coupled to the laser source 105, the user input device 135, and the display device 130, as well as (optionally) one or more sensors 125 (as discussed above with reference to procedures 1800, 1900, and 2000). Although only one sensor 125 is shown in Figure 22, it should be understood that two or more sensors may be used in the lithotomy system. According to at least one embodiment, the sensor 125 is configured to measure at least one input parameter and / or at least one procedure parameter. It should also be understood that the sensor 125 may, for example, be a video sensor of the treatment area as part of an endoscope, and the processed endoscopic video may be used for calculating the fiber tip velocity and / or fiber gap distance, as well as for calculating the N factor in real time and / or adjusting the laser parameters (which is an automated algorithm, as described with reference to Figure 20). The endoscope may include a processor configured to determine these values, but for simplicity, it should be understood that this function will be described here using the controller 150 in Figure 22. Fiber velocity can be measured using a variety of other methods and devices, such as a velocity sensor integrated into the distal tip of the endoscope.

[0243] The controller 150 includes circuits that may be separate or integrated components. It will be understood by those skilled in the art that the operations performed by the controller 150 may be performed by one or more controllers, processors, and / or other electronic components, including software and / or hardware components. For example, the controller 150 includes a processor 145 (which may include two or more processors and may also be referred to as a central processing unit CPU, as understood by those skilled in the art), a computer-readable storage device (not explicitly shown in Figure 22), and memory 140 (also referred to as a storage device or storage memory), as well as other hardware and software components as understood by those skilled in the art.

[0244] The processor 145 may be a single-core or multi-core processor, or multiple processors for parallel processing, and may execute a set of machine-readable instructions that can be embodied in a program or software. The instructions may be stored in a memory location such as memory 140. The instructions may be directed to the processor 145, which may then be programmed or otherwise configured to implement the methods and / or steps of the present disclosure.

[0245] The storage memory 140 includes one or more computer-readable and / or writable media, which may include, for example, magnetic disks (e.g., hard disk drives HDDs), optical disks (e.g., DVDs, Blu-ray®, etc.), magneto-optical disks, semiconductor memory (e.g., non-volatile memory cards, Flash® memory, solid-state drives, SRAM, DRAM), EPROMs, EEPROMs, etc. The storage memory 140 may store computer-readable data and / or computer-executable instructions, including operating system (OS) programs and control and processing programs.

[0246] The electronically stored information is stored in the memory 140 of the controller 150. According to at least one embodiment, the electronically stored information may include lookup tables, empirical functions, and / or analytical models. In some embodiments, this information is generated by inputting results from preclinical and clinical trials, studies, and research.

[0247] The controller 150 can display data (e.g., one or more treatment parameters, Nf, Nfmax, etc.) on the display device 130. The display device may provide three-dimensional or two-dimensional images, and non-limiting examples include touchscreen displays and / or flat-panel displays, or any other suitable visual output devices capable of displaying graphical data and / or text to the user. In some embodiments, a touchscreen may function as both the display device 130 and the user input device 135. According to at least one embodiment, the controller 150 is configured to generate a graphical user interface (GUI) on the display device 130 that receives user input in conjunction with the user input device 135.

[0248] The systems and user interfaces disclosed herein may enable physicians and technicians to make smarter and faster decisions to improve the outcomes of lithotomy procedures (e.g., optimize stone removal), reduce procedure time, and lessen the cognitive load required during the procedure. This is especially true when the system is more fully automated with control / monitoring using a computer, such as the algorithm described above in Figure 20, which provides the most precise control of laser parameters and the N factor, as well as the shortest procedure time.

[0249] robot systems In some embodiments, joystick control of a mechanical arm that controls the position and movement of the fiber is considered. The clinician controls the insertion and positioning of the device via joystick control, which moves and positions the fiber and, optionally, the endoscope together more precisely. The velocity and position of the fiber can be measured directly via sensors that monitor electronic / pneumatic signals to and from the mechanical arm / joystick control system. This information can be used in the laser control portion of the algorithms discussed above in this disclosure. In addition, images from the endoscope camera can be processed by image processing algorithms that can, for example, assess the type of stone, verify the fiber velocity and position (used in conjunction with the electronic sensing signals mentioned above), and detect unsafe conditions within the treatment zone, such as a fiber directed towards an unsafe target. The laser control module receives data for adjusting the laser parameters discussed above in this disclosure. Referring to Figure 22 as mentioned earlier, the display device 130 and the user input device 135 can be combined into a single subsystem, e.g., a computer applicable to this monitoring and control system. Computer algorithms can perform calculations in real time to update laser parameters, assess unsafe conditions, and provide corrective feedback much faster than a human could if erroneous fiber movement is detected.

[0250] The embodiments disclosed herein in accordance with the present invention are not limited in their application to the configuration details and arrangement of components described below or illustrated in the accompanying drawings. These embodiments may envision other embodiments and may be carried out or implemented in various ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to limit them. Specifically, actions, components, elements, and features considered in relation to any one or more embodiments are not intended to be excluded from similar roles in any other embodiments.

[0251] Furthermore, the expressions and terms used herein are for illustrative purposes only and should not be considered limiting. Any singular reference to an example, embodiment, component, element, or act of a system or method herein may include plural embodiments, and any plural reference to any embodiment, component, element, or act herein may include singular embodiments. References in the singular or plural form are not intended to limit the systems or methods, their components, acts, or elements of the disclosure. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof herein means that they include the items and their equivalents listed thereafter, as well as additional items. References to “or” may be interpreted as comprehensive, such that any term used with “or” may refer to one, two or more, or all of the terms listed. In addition, if there is any inconsistency in the use of terms between this specification and the literature incorporated herein by reference, the use of terms in the incorporated reference shall complement the use herein. In the event of any inconsistency, the use of terminology as defined herein shall prevail. Furthermore, headings or subtitles may be used herein for the convenience of the reader, and these shall not affect the scope of the invention.

[0252] Although several aspects of at least one embodiment have been described in this manner, it should be understood that various changes, modifications, and improvements will be readily conceivable to those skilled in the art. For example, the examples disclosed herein may be used in other contexts. Such changes, modifications, and improvements are intended to be part of this disclosure and within the scope of the embodiments considered herein. Accordingly, the foregoing description and drawings are merely examples.

Claims

1. A system for use in laser lithotripsy procedures, A laser source configured to generate pulsed laser energy, An optical fiber configured to direct the pulsed laser energy toward a target, The system comprises a controller coupled to the laser source, and the controller is It receives one or more input parameters, Determine at least one treatment parameter, wherein the at least one treatment parameter includes one or more laser operation parameters. Based at least partially on one or more treatment parameters and at least one input parameter, an N factor (Nf) is calculated, wherein Nf corresponds to the number of laser pulses delivered to the treatment zone having a diameter approximately equal to the diameter of the laser crater (Dc) generated by the pulsed laser energy directed to the treatment zone on the target. Compare Nf with the maximum value Nf (Nfmax), and In response to the determination that Nf is greater than Nfmax, at least one of the one or more laser operating parameters is adjusted, or A system configured to control the laser source using one or more laser operating parameters in response to a determination that Nf is less than or equal to Nfmax.

2. The system according to claim 1, wherein the one or more laser operating parameters include pulse energy, pulse frequency, average power, peak power, and / or pulse width.

3. The system according to claim 1, wherein when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust at least one laser operating parameter so that Nf is less than or equal to Nfmax.

4. The aforementioned controller, The Nf is displayed on a display device connected to the controller, and In response to the determination that Nf is greater than Nfmax, a negative alert message is output on the display device, or The system according to claim 1, further configured to output a positive alert message on the display device in response to the determination that Nf is less than or equal to Nfmax.

5. The system according to claim 1, wherein the one or more treatment parameters used to calculate Nf include a laser pulse frequency, a laser crater diameter (Dc), and an optical fiber velocity (υ).

6. Nf is calculated according to the following formula: Nf=(f ＊ D ｃ ) / υ In the formula, f (Hz) is the laser pulse frequency, and D ｃ The system according to claim 5, wherein (mm) is the diameter of the laser crater and υ is the speed of the optical fiber directing the pulsed laser energy to the treatment zone.

7. The laser crater diameter Dc is within the range specified by the following formula: [Math 1] In the formula, NA is the numerical aperture of the fiber, Δ (mm) is the gap between the tip of the optical fiber and the surface of the calculus, d (mm) is the core diameter of the optical fiber, and P ｐｅａｋ (W) is the peak power of the laser pulse, and E １ (J) is the single pulse energy, and F' (J / cm) ２ The system according to claim 6, wherein ) is the threshold for lithotripsy.

8. The system according to claim 1, wherein the controller is configured to calculate Nfmax, which corresponds to the number of laser pulses delivered to the treatment zone having a diameter substantially equal to the laser crater diameter Dc, providing an average stone ablation efficiency per pulse for a maximum number of pulses that are greater than or equal to a predetermined K value corresponding to the ablation efficiency achieved after a collision from a single (first) pulse.

9. The system according to claim 8, wherein the K value is in the range of approximately 25 to 75%.

10. The system according to claim 9, wherein the K value is in the range of approximately 25 to 50%.

11. The controller is configured to calculate Nfmax, which is calculated according to the following formula: Nfma8=(12.4-3.1d)+(3.3d-8.4) / (1+4.7×10 －５ exp(P ｐｅａｋ / 0.0375))-((14.7]-16)+(80-65])P ｐｅａｋ +(55d-62)P ｐｅａｋ ２ ) / (1+0.34E ５．５－２．６Ｐｐｅａｋ ) In the formula, P ｐｅａｋ The system according to claim 1, wherein the peak power is...

12. The system according to claim 1, wherein Nfmax is in the range of 1 to 12.

13. The system according to claim 12, wherein Nfmax is in the range of 1 to 7.

14. The system according to claim 13, wherein Nfmax is in the range of 1 to 5.

15. The system according to claim 14, wherein Nfmax is in the range of 1 to 3.

16. The system according to claim 1, wherein the controller is configured to display at least one laser operating parameter on a display device based on the comparison.

17. The system according to claim 1, wherein the controller is configured to display at least one of Nf and Nfmax on a display device.

18. The system according to claim 1, further comprising at least one sensor coupled to the controller and configured to measure at least one input parameter and / or at least one treatment parameter.

19. The system according to claim 18, wherein the at least one sensor includes a sensor configured to measure fiber velocity.

20. The system according to claim 19, wherein when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust the at least one laser operating parameter so that Nf is less than or equal to Nfmax.

21. The aforementioned controller, In response to a determination that Nf is greater than Nfmax, a negative alert message is output, which includes at least one of an audio alert message, a visual alert message, and a haptic alert message, or The system according to claim 1, further configured to output a positive alert message including at least one of an audio alert message, a visual alert message, and a haptic alert message in response to a determination that Nf is less than or equal to Nfmax.

22. The system according to claim 1, wherein the controller is configured to output an alert message in response to the comparison, the alert message comprising at least one of an audio alert message, a visual alert message, and a haptic alert message.

23. The system according to claim 22, further comprising a user input device coupled to the controller, the user input device being configured to receive input from a user, the input comprising at least one value for a laser operating parameter used by the controller to control the laser source.

24. The system according to claim 23, wherein the alert message includes information to the user regarding whether Nf is greater than Nfmax or whether Nf is less than or equal to Nfmax.

25. The system according to claim 1, wherein the input parameter includes at least one of a target parameter, a system parameter, and a safety parameter.

26. The system according to claim 25, wherein the input parameters include target parameters, and the target parameters include target type, target location, and one or more target characteristics.

27. The system according to claim 26, wherein the target is a calculus lesion, and the one or more target characteristics include the size and / or hardness of the calculus lesion.

28. The system according to claim 27, wherein the input parameter includes at least one system parameter, the at least one system parameter includes fiber diameter and / or fiber numerical aperture.

29. The system according to claim 23, wherein the input parameters include at least one safety parameter, the at least one safety parameter includes a maximum average power, a maximum peak power, a maximum pulse energy, and / or a maximum pulse frequency.

30. A method for performing laser lithotripsy, This includes providing a controller, the controller being, It receives one or more input parameters, Determine at least one treatment parameter, wherein the at least one treatment parameter includes one or more laser operation parameters. Based at least partially on one or more treatment parameters and at least one input parameter, an N factor (Nf) is calculated, wherein Nf corresponds to the number of laser pulses delivered to the treatment zone having a diameter approximately equal to the laser crater diameter (Dc) generated by pulsed laser energy directed to the treatment zone on the target. Compare Nf with the maximum value Nf (Nfmax), and In response to the determination that Nf is greater than Nfmax, adjust at least one laser operating parameter, or A method configured to control a laser source using one or more laser operating parameters in response to a determination that Nf is less than or equal to Nfmax.

31. The method according to claim 30, wherein when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust the at least one laser operating parameter so that Nf is less than or equal to Nfmax.

32. The aforementioned controller, The Nf is displayed on a display device connected to the controller, and In response to the determination that Nf is greater than Nfmax, a negative alert message is output on the display device, or The method according to claim 30, further configured to output a positive alert message on the display device in response to the determination that Nf is less than or equal to Nfmax.

33. Nf is calculated according to the following formula: Nf=(f ＊ D ｃ ) / υ In the formula, f (Hz) is the laser pulse frequency, and D ｃ The method according to claim 32, wherein (mm) is the diameter of the laser crater and υ is the speed of the optical fiber directing the pulsed laser energy to the treatment zone.

34. The laser crater diameter Dc is within the range specified by the following formula: [Math 2] In the formula, NA is the numerical aperture of the fiber, Δ (mm) is the gap between the tip of the optical fiber and the surface of the calculus, d (mm) is the core diameter of the optical fiber, and P ｐｅａｋ (W) is the peak power of the laser pulse, and E １ (J) is the single pulse energy, and F' (J / cm) ２ The method according to claim 33, wherein ) is the threshold for lithotripsy.

35. The method according to claim 30, wherein the controller is configured to calculate Nfmax, the number of laser pulses delivered to the treatment zone having a diameter substantially equal to the laser crater diameter Dc, which provides an average stone ablation efficiency per pulse for a maximum number of pulses that are greater than or equal to a predetermined K value corresponding to the ablation efficiency achieved after a collision from a single (first) pulse.

36. The method according to claim 35, wherein the K value is in the range of approximately 25 to 75%.

37. The controller is configured to calculate Nfmax, which is calculated according to the following formula: Nfma8=(12.4-3.1d)+(3.3d-8.4) / (1+4.7×10 －５ exp(P ｐｅａｋ / 0.0375))-((14.7]-16)+(80-65])P ｐｅａｋ +(55d-62)P ｐｅａｋ ２ ) / (1+0.34E ５．５－２．６Ｐｐｅａｋ ) In the formula, P ｐｅａｋ The method according to claim 30, wherein the peak power is...

38. The method according to claim 30, wherein Nfmax is in the range of 1 to 12.

39. The method according to claim 30, further comprising measuring at least one input parameter and / or at least one treatment parameter using at least one sensor.

40. The method according to claim 39, wherein the at least one input parameter includes fiber velocity.

41. The method according to claim 40, wherein when the controller determines that Nf is greater than Nfmax, the controller is configured to adjust the at least one laser operating parameter so that Nf is less than or equal to Nfmax.

42. The method according to claim 30, wherein the controller is configured to output an alert message in response to the comparison, the alert message comprising at least one of an audio alert message, a visual alert message, and a haptic alert message.

43. The method according to claim 42, wherein the controller is further configured to receive input from a user input device, the input comprising at least one value of a laser operating parameter used by the controller to control a laser source.

44. The method according to claim 43, wherein the alert message includes information regarding whether Nf is greater than Nfmax or whether Nf is less than or equal to Nfmax.

45. A system for use in laser lithotripsy procedures, A laser source configured to generate pulsed laser energy, An optical fiber configured to direct the pulsed laser energy toward a target, The system comprises a controller coupled to the laser source, and the controller is It receives one or more input parameters, Determine at least one treatment parameter, wherein the at least one treatment parameter includes one or more laser operation parameters. Based at least partially on one or more treatment parameters and at least one input parameter, an N factor (Nf) is calculated, wherein Nf corresponds to the number of laser pulses delivered to the treatment zone having a diameter approximately equal to the diameter of the laser crater (Dc) generated by the pulsed laser energy directed to the treatment zone on the target. The Nf is displayed on a display device connected to the controller, and The laser operating parameters are compared with a threshold, and In response to the determination that the laser operating parameter is greater than the threshold, at least one of the one or more laser operating parameters is adjusted, or A system configured to control the laser source using one or more laser operating parameters in response to a determination that the laser operating parameters are less than the threshold.

46. The system according to claim 45, wherein the laser operating parameter compared to the threshold is pulse energy.

47. The system according to claim 46, wherein the controller is further configured to calculate the pulse energy based at least in part on the pulse frequency.

48. The system according to claim 47, wherein the controller is further configured to calculate the pulse frequency based at least in part on a maximum N factor (Nmax).

49. The system according to claim 45, wherein the controller is configured to adjust the at least one laser operating parameter such that Nf is determined to be less than or equal to the maximum N factor Nfmax.

50. The system according to claim 45, wherein, in response to a determination that the laser operating parameter is greater than the threshold, the controller is configured to adjust the laser operating parameter value to the maximum safe value associated with the laser operating parameter.

51. The system according to claim 45, wherein the controller is configured to display at least one laser operating parameter based on the comparison.

Images