Systems and methods for controlling laser treatment

Abstract

To provide an improved system and method for controlling medical procedure processing. [Solution] The surgical laser system comprises a surgical optical fiber optically coupled to a light source, and a photodetector configured to receive a portion of light reflected from a treatment target, and to generate optical data corresponding to the portion of reflected light interacting with the photodetector. The system also comprises a computing device configured to analyze the optical data against a characteristic criterion, and to control the operation of the laser source based on a comparison of the optical data with the characteristic criterion.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Patent Application No. 63 / 062,118, titled "Artificial Intelligent Assisted Laser Urology Platform," filed on August 6, 2020, and U.S. Provisional Application No. 63 / 184,970, titled "Intelligent System to Facilitate Treatment of Tissues and Calculi with Directed Energy," filed on May 6, 2021, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Directed energy (such as electromagnetic including light, mechanical, and acoustic including ultrasonic) is increasingly being chosen as a method to treat various pathological conditions in the human body. One type of pathological condition for which directed energy is used in treatment is urolithiasis, including kidney stones and bladder stones, which are estimated to affect 12% of the world's population. Most patients with nephrolithiasis can pass the stones naturally, but in severe cases of nephrolithiasis (e.g., where the patient cannot pass the kidney stones), medical intervention, including the use of directed energy, is required. Leaving severe cases of nephrolithiasis untreated can be immediately followed by extreme pain, nausea, vomiting, infections, obstruction of urine flow, and loss of kidney function.

[0003] Laser lithotripsy is a method of treating urinary tract stones using directed energy, targeting the stones with directed laser energy delivered through a fiber. Laser lithotripsy can be advantageous over other forms of directed energy (such as ultrasound) because the laser light during laser lithotripsy can be delivered by a fiber flexible enough to curve and traverse various hard-to-reach structures. Furthermore, the small outer diameter of the fiber allows it to be inserted into the working channels of most surgical instruments, including virtually all scopes (rigid, semi-rigid, and flexible) used in urology. In laser lithotripsy, directed light energy from the laser is delivered to the stone, breaking it down into smaller particles that can pass through naturally, or larger fragments that can be removed using auxiliary tools (such as baskets). Alternatively, larger fragments can also be aspirated through the working channel of a scope (such as an endoscope). [Overview of the Initiative] [Problems that the invention aims to solve]

[0004] Typically, during laser lithotripsy, medical professionals (such as doctors and surgeons) identify the target of the stone by receiving images of the patient's internal region using a built-in endoscope camera. However, because the camera is the only device providing feedback to medical professionals, problems with the camera or image acquisition process (e.g., temporary obstruction of the camera's surgical field, malfunction of the camera's electronics) and variations in the surgeon's reaction time can lead to inaccuracies, inefficiencies, errors, and prolonged treatment times. Therefore, it is desirable to improve the systems and methods that control the medical procedure. [Means for solving the problem]

[0005] The embodiments and non-limiting examples relate to methods and systems for performing laser surgical treatment.

[0006] According to one aspect of the present disclosure, a surgical laser system is provided comprising a light source and a surgical fiber optically coupled to a photodetector configured to receive a portion of light from the light source that has been reflected from a treatment area, and to generate optical data corresponding to the portion of reflected light detected by the photodetector. The system includes a computing device configured to analyze the optical data against a characteristic criterion and to control the operation of the laser source based on a comparison of the optical data with the characteristic criterion.

[0007] In some embodiments, the light source is an illumination source associated with a scope configured to deliver a surgical fiber to the treatment area.

[0008] In some embodiments, the light source is a light-emitting diode (LED) or a lamp.

[0009] In a further embodiment, the light source is a probing beam configured to deliver light to the treatment area via a surgical fiber.

[0010] In some embodiments, the probing beam is a laser having a wavelength substantially within the wavelength range of 350 nm to 2700 nm.

[0011] In some embodiments, the probing beam is an LED.

[0012] In a further embodiment, the probing beam is a therapeutic laser source.

[0013] In some embodiments, the light source is thermal radiation from the treatment site.

[0014] In a further embodiment, the light source is fluorescence excited in the treatment area by a probing beam.

[0015] In some embodiments, the computing system is further configured to use optical data to determine whether the therapeutic target within the therapeutic area is a stone or tissue.

[0016] In a further embodiment, the computing system is further configured to use optical data to determine the type of stone or tissue.

[0017] In some embodiments, the computing system is further configured to use optical data to determine at least one of the following: a fracture of the surgical fiber within the scope or the location of the distal end of the surgical fiber.

[0018] In a further embodiment, the computing system is further configured to use optical data to determine the distance between the distal end of a surgical fiber and a therapeutic target within the treatment area.

[0019] In some embodiments, the computing system is further configured to use optical data to determine the distance between the distal end of a surgical fiber and a therapeutic target within the treatment area.

[0020] In some embodiments, the computing system is further configured to determine the temperature of the distal end of the fiber.

[0021] In a further embodiment, the computing system is further configured to determine flashing within the treatment area.

[0022] In some embodiments, a laser source configured for lithotripsy is included.

[0023] In a further embodiment, controlling the operation of a laser source includes controlling at least one of the following: power, pulse peak power, pulse shape, pulse width, pulse energy, interval between pulses, repetition rate, average power, and continuous wave (CW) power.

[0024] In some embodiments, the computing system is further configured to generate a visual or an audio signal for an operator.

[0025] In a further embodiment, the light detector is a photodiode.

[0026] In some embodiments, the light detector is a spectrometer.

[0027] In a further embodiment, a method of operating a surgical laser system is disclosed that includes placing a surgical fiber to receive a portion of light reflected from a treatment area and using a light detector from the surgical fiber to receive the portion of light reflected from the treatment area and generate optical data corresponding to the portion of the reflected light detected by the light detector. The method may also include using a computing device to analyze the optical data against a characteristic criterion and, based on a comparison of the optical data and the characteristic criterion, controlling the operation of the laser source or providing an audio or visual signal to an operator to control the laser source.

[0028] In other embodiments, the method may include using a computing system to determine, using the optical data, that a treatment target within the treatment area is a stone or tissue.

[0029] In some other embodiments, the method includes using a computing system to determine, using the optical data, at least one of a break in the surgical fiber within the scope or the position of the distal end of the surgical fiber.

[0030] In other embodiments, the method may include using a computing system to determine, using the optical data, the distance between the distal end of the surgical fiber and the treatment target.

[0031] In other embodiments, the method may include the step of generating a portion of the reflected light using a light source including at least one of a light-emitting diode (LED) light source, a laser source, a lamp light source, or a fluorescent light source.

[0032] In another embodiment, the method may include the step of using a computing system to determine the type of stone or tissue to be a therapeutic target within a therapeutic area using optical data.

[0033] In another embodiment, the method may include the step of using a computing system to determine the temperature of the distal end of a surgical fiber using optical data.

[0034] In another aspect of the present disclosure, an integrated surgical laser system is disclosed, comprising a laser source configured to emit laser light configured for use on a patient's therapeutic target, and a surgical optical fiber configured to have a distal end positioned in close proximity to the patient's therapeutic target during a surgical laser procedure. The system may also include a surgical scope configured to deliver the surgical fiber to a treatment area and to receive optical data from the treatment area, and a computing device configured to analyze the optical data in relation to a characteristic criterion and to control the operation of the laser source during a surgical laser procedure based on a comparison of the optical data with the characteristic criterion.

[0035] In another embodiment, the system may include at least one of a suction subsystem, a scrubbing subsystem, or a suction / scrubbing subsystem, configured to deliver a scrubbing fluid or scrubbing / suction fluid to a treatment area via a surgical scope, generate data relating to the flow or pressure of the scrubbing / suction fluid, and communicate the generated data with a computing device.

[0036] In a further embodiment, the system may include an imaging system configured to acquire images of therapeutic targets.

[0037] In another embodiment, the computing system is configured to use optical data to detect at least one therapeutic target stone or tissue.

[0038] In some other embodiments, the computing system is configured to use optical data to determine at least one of the types of stones or tissues in the therapeutic target.

[0039] In another embodiment, the computing system is configured to use optical data to determine at least one of the positions or distances of the distal end to the therapeutic target.

[0040] In a further embodiment, the computing system is configured to control an integrated surgical laser system to use optical data to sharpen the field of view of the treatment area.

[0041] In another embodiment, the computing system is configured to determine the presence of flashes or plasma within the treatment area.

[0042] In some other embodiments, the computing system is configured to determine the performance of aspiration or irrigation during surgical laser procedures.

[0043] Another aspect of this disclosure discloses a surgical laser system which may include a laser source configured to emit laser light configured for use on a patient's therapeutic target, and a surgical optical fiber configured to have a distal end positioned in close proximity to the patient's therapeutic target during a surgical laser procedure. The system may also include an optical adapter which optically couples the laser source to the proximal end of the surgical optical fiber, and a photodetector which is optically coupled to the optical adapter and configured to receive a portion of the light reflected from the therapeutic target and generate optical data corresponding to a portion of the reflected light received by the photodetector. The system may also include a computing device configured to analyze the optical data against a characteristic criterion and to control the operation of the laser source during a surgical laser procedure based on a comparison of the optical data with the characteristic criterion.

[0044] In other embodiments, the system may include at least one of a suction subsystem, a washing subsystem, or a suction / washing subsystem.

[0045] In some embodiments, the system may include artificial intelligence (AI) that manages an execution control center configured to control the operation of a subsystem of a surgical laser system.

[0046] In other embodiments, the system may include a scope configured to position the proximal end of a surgical optical fiber and an imaging system configured to acquire an image of a therapeutic target.

[0047] In another embodiment, the system may include an illumination source configured to illuminate a therapeutic target during treatment.

[0048] Further aspects, non-limiting examples, and the merits of these exemplary aspects and non-limiting examples will be discussed in detail below. Furthermore, it should be understood that both the information stated herein and the detailed description below are merely illustrative examples of various aspects and non-limiting examples, and are intended to provide an overview or framework for understanding the nature and characteristics of the claimed aspects and non-limiting examples. The non-limiting examples disclosed herein can be combined with other non-limiting examples, and references such as “non-limiting example,” “one example,” “several non-limiting examples,” “several examples,” “alternative non-limiting examples,” “various non-limiting examples,” “one non-limiting example,” “limiting example,” “at least one non-limiting example,” “this and other non-limiting examples,” and “a specific non-limiting example” 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 non-limiting example. The appearance of such terms herein does not necessarily all refer to the same non-limiting example.

[0049] The aforementioned and other aspects and advantages of this disclosure will become apparent from the following description. The description refers to the accompanying drawings, which form part of this specification, and which illustrate one or more exemplary variations. These variations do not necessarily represent the entire scope of the disclosure.

[0050] The following drawings are provided to illustrate various features of non-limiting examples of this disclosure and are not intended to limit the scope of this disclosure or exclude alternative implementations. [Brief explanation of the drawing]

[0051] [Figure 1] This is a schematic diagram of a non-limiting example of a smart laser system according to the embodiments of this disclosure. [Figure 2] This is a schematic diagram of an integrated laser surgery system equipped with the smart laser system shown in Figure 1, performed in a surgical environment. [Figure 3]Figure 2 is a schematic diagram of the optical adapter. [Figure 4] Figure 1 is a schematic diagram of a non-limiting example of a smart laser system, further illustrating additional or optional components of the system. [Figure 5] Figure 5 shows a schematic diagram of another laser system. Figure 5 also shows a schematic diagram of an optical adapter according to an embodiment of the present disclosure. [Figure 6] Figure 6 is a schematic diagram of another laser system. Figure 6 also shows a schematic diagram of another example of an optical adapter according to an aspect of the present disclosure. [Figure 7] This is a schematic diagram of another laser system, and a schematic diagram of yet another example of an optical adapter according to an aspect of the present disclosure. [Figure 8] This is a cross-sectional view of a multicore fiber and a light source and photodetector interacting with it. [Figure 9] This is a schematic diagram of a smart laser system utilizing fluorescence emission according to an aspect of this disclosure. [Figure 10] This describes the fluorescence response of human soft tissue (mucosa) and stones (calcium monophosphate oxalate) according to one or more embodiments of the present disclosure. [Figure 11] This is a graph of the autofluorescence response (e.g., fluorescence spectrum) to three different types of target substances (e.g., calcium oxyate monohydrate, struvite, and xanthine). [Figure 12] This is a schematic diagram of another example of a laser system. [Figure 13] This table outlines the specific functions of optical adapters. [Figure 14] This is a table of different examples of the types of features and functions provided by laser systems according to aspects of this disclosure. [Figure 15A] This is a flowchart of the process for determining whether a therapeutic target is a target substance or tissue. [Figure 15B] This graph shows an example of an optical data profile for use in laser treatment, as disclosed herein. [Figure 16]This graph shows examples of LED reflectance spectra for different therapeutic targets normalized to the maximum level, according to aspects of this disclosure. [Figure 17] This graph shows examples of LED light reflection spectra that are not LED normalized for the spectra of LEDs against different targets, according to aspects of this disclosure. [Figure 18] This is a table of the total (integral) values ​​of the reflected light from an LED in a specific spectral range for signals of different targets, according to aspects of this disclosure. [Figure 19] This graph shows examples of stone / tissue ratio spectra for different therapeutic targets according to aspects of this disclosure. [Figure 20] This is a flowchart of the process for determining whether a therapeutic target is a target substance or tissue. [Figure 21] This is a flowchart of the process for determining the distance between the distal end of the fiber and the therapeutic target. [Figure 22] This is a further flowchart for Figure 21 showing the process for determining the distance between the distal end of the fiber and the therapeutic target. [Figure 23] Figure 23 is a schematic diagram of a calibration routine according to an embodiment of the present disclosure. The upper part of Figure 23 is a schematic diagram of a calibration routine using a pulsed probing or pilot beam source according to an embodiment of the present disclosure. The lower part of Figure 23 is a schematic diagram of a calibration routine using a continuous wave probing source or pilot beam according to an embodiment of the present disclosure. [Figure 24] This is a graph showing the relationship between the contact coefficient value and the contact distance between the tip of the fiber and the target, according to an aspect of this disclosure. [Figure 25] This is a graph showing the relationship between the derivative of the contact coefficient and the contact distance between the tip of the fiber and the target, according to an aspect of this disclosure. [Figure 26] This is a graph showing the relationship between the contact coefficient and different types of stone and soft tissue materials, according to aspects of this disclosure. [Figure 27] This is a flowchart of the process for determining the presence of plasma within the treatment area. [Figure 28]This graph illustrates the spectral responses from two different physiological substances according to the embodiments of this disclosure. [Figure 29] This is another graph illustrating spectral responses from two different physiological substances according to aspects of the present disclosure. [Figure 30] This is a flowchart of the process for determining the temperature of the components of a laser system or the treatment area. [Figure 31] This is a flowchart of the process for determining the presence of bubbles within the treatment area. [Figure 32] This graph shows the pulse energy characteristics of different portions of pulsed laser emission for ablation and coagulation applications, respectively, according to aspects of this disclosure. [Figure 33] This is another graph showing the pulse energy characteristics of different portions of pulsed laser emission in ablation and coagulation applications, respectively, according to aspects of this disclosure. [Figure 34] This is a flowchart of the process for detecting problems related to optical transmission through a fiber. [Figure 35] This is another example of a functional diagram of a different laser system. [Figure 36] This is a flowchart of the process for determining the distance between the distal end of the fiber optic cable and the distal end of the medical scope. [Figure 37] This is a schematic diagram showing different surgical fiber tip positions relative to the distal end of an endoscope according to aspects of the present disclosure. [Figure 38] This graph shows the relationship between the LED signal measured by the laser system and the position of the distal end of the fiber in the endoscope according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0052] As described above, there are various medical procedures and treatments that utilize lasers and phototherapy. One non-limiting example of medical treatment is the optical or laser treatment of target materials using optical fibers, which are surgical optical fibers. In non-limiting examples, the target material may include stones or calculi, or other substances. Stones or calculi may be located in the bladder (e.g., often called bladder stones), in the kidneys (e.g., often called kidney stones), in the kidneys or other parts of the urinary system (e.g., called urinary tract stones, kidney stones, or other stones), or elsewhere. Additionally or alternatively, the target material may not be a stone or calculi, or may not be related to the kidneys or urinary system, but may be a substance located elsewhere in the body or in other systems of the body. Other relevant examples of laser procedures include the treatment of various urinary tract conditions such as benign prostatic hyperplasia (BPH), bladder / prostate cancer, and ureteral stricture. In these procedures, laser energy is used for tissue ablation / vaporization, incision, coagulation, and hemostasis. Furthermore, essentially the same procedures are used in other surgical fields, such as gastroenterology and laryngosurgery.

[0053] Regardless of the specific clinical application or target substance, it can be challenging for healthcare professionals to perform medical procedures on target substances within a patient. For example, the camera's field of view (FOV) may only become clear immediately before the laser pulse is applied to the target substance, and therefore the laser pulse can obscure the camera's FOV (e.g., the laser pulse undesirably interacts with the camera's image sensor, thereby hindering the clear representation of features in the image, including the laser beam against the target substance). Therefore, relying solely on image data from an endoscope camera may only yield a non-ideal image of the surgical field, which may have limitations in spatial and temporal resolution. Furthermore, even assuming perfectly clear image data, safe and efficient treatment requires a wide range of healthcare professional skills, abilities, and experience (e.g., healthcare professionals who can respond to changing situations during treatment).

[0054] As another example, the interaction between the light from the laser and the target material can make it difficult to ensure that the laser beam is actually directed at the target material (not healthy tissue) throughout all the procedures. Laser lithotripsy excision procedures can be characterized by several processes, including (1) the formation of water vapor bubbles (and vapor channels) in front of the distal end of the fiber, (2) the superheating of water in the operating region due to the absorption of laser energy, and (3) the formation of craters on the target material (with the effect of backward migration), which ultimately leads to the fragmentation and pulverization of the target material (e.g., stone).

[0055] During each of these processes, fragments of stone and air bubbles (including water vapor) can be tracked in all directions, scattering the light and obstructing or obscuring the view of the treatment area. In fact, as the procedure progresses naturally, the camera's FOV can become increasingly clogged (due to contamination, etc.), eventually making it very difficult to identify targets in the image from the camera. At these moments, some medical professionals consider two options. First, the medical professional can take a more lenient approach to the treatment and direct the laser at what they believe to be the target material (or particles of the target material). However, because the medical professional's "viewpoint" becomes obscured (e.g., the camera's FOV becomes significantly obscured), the risk of collateral damage to soft tissue (e.g., inadvertently directing the laser beam at a non-treatment target, including healthy tissue) can increase significantly, as can the risk of fiber breakage (e.g., due to mechanical pressure on the stone). Secondly, medical professionals may take a more conservative approach to treatment, which may include stopping the firing, reducing laser power, or temporarily increasing the flow of irrigation fluid (for example, to sharpen the camera's field of view). However, undesirable consequences of this conservative approach may include prolonged treatment time, extended anesthesia time (which can be very important in some cases), and significantly increased treatment costs (e.g., requiring multiple treatment sessions) by limiting the medical professional's ability to complete treatment in a single session. Regardless of the treatment approach, major complications involving soft tissue damage (which are very rare, occurring in less than 1% of interventions) can still occur and can be very serious. In fact, in the most serious cases, this can lead to perforation of the kidney or ureter wall, ultimately requiring unnecessary emergency kidney or ureteral surgery.

[0056] While accurately and precisely directing the laser beam to the treatment target is one crucial aspect of laser lithotripsy (and other laser-based procedures to address target material), other critical aspects exist, including those related to safety and efficiency. For example, during lithotripsy or surgical soft tissue procedures, including the treatment of benign prostatic hyperplasia (BPH), and the incision or evaporation of vesicoureteral and renal tumors, there are multiple conditions within the surgical area that influence the efficiency of tissue interaction and the overall quality of clinical outcomes. Some of these conditions include (1) using laser operating parameters appropriate for the specific target tissue or stone type, (2) accurately determining the distance from the distal end of the surgical optical fiber to the tissue surface (e.g., to ensure that the laser beam is properly directed to the treatment target), (3) ensuring that the quality of the distal end of the surgical optical fiber is maintained throughout the procedure (e.g., to ensure that the distal end of the surgical optical fiber is clear enough to transmit the laser beam to the treatment target), and (4) ensuring that the laser beam does not unnecessarily obscure the FOV and does not impair the visibility of the medical personnel (e.g., a plasma flame to block the laser radiation). This includes (5) ensuring that the temperature of the treatment area (or in other words, the working area) does not rise to an undesirable level (e.g., potentially damaging healthy tissue within the treatment area), (6) ensuring that the presence of vapor bubbles and controlling their growth to efficiently process the target material, (7) ensuring that the fiber is undamaged (e.g., not damaged) and properly positioned within the scope, (8) ensuring that stone movement during laser ablation is minimized to maintain contact or near-contact with the target, and (9) ensuring that accidental breakage of the fiber within the scope does not lead to damage to the scope, etc. The ability to properly recognize and respond to these conditions greatly improves the outcome of the treatment (e.g., efficiency, safety, etc.), but currently, in general laser lithotripsy, even detecting these conditions is difficult, if not impossible, let alone dealing with them properly.In other words, typical laser lithotripsy systems cannot even detect these conditions.

[0057] Some non-limiting examples of this disclosure provide advantages to these problems (and others) by providing improved systems and methods for treating certain target materials, including medical stones or litholiths and soft tissue lesions. For example, some non-limiting examples of this disclosure provide systems and methods for detecting the above (and others) conditions and appropriately addressing them. In some cases, simply detecting the conditions can greatly assist healthcare professionals (or computing devices) in achieving safe and effective laser treatment and appropriately addressing them (for example, by interpreting diagnostic information obtained from the treatment site and surrounding areas) by analyzing the conditions.

[0058] In some non-limiting examples, a laser system (e.g., the computing device of the laser system) can determine the distance between the therapeutic target or target material (e.g., kidney stones) and act appropriately based on the determined distance (e.g., modifying therapeutic laser parameters such as CW power, pulse peak power, pulse shape and pulse width, interval between pulses, pulse frequency and average power, completely blocking the laser light, notifying the operator of the detected state, etc.). In this way, targeting of the laser light to the target material can be made more efficient. For example, if the surgical optical fiber is not in complete contact with the target material, and more laser energy is spent heating water while the laser is emitting pulses, the ablation efficiency decreases, which reduces the fluency (power density) of the laser at the therapeutic target. In other words, the laser light is not as focused on a specific location in the target material where liquid water has already evaporated, but rather distributed more around the area surrounding that specific location containing liquid water, so that the laser light is used to heat the water (rather than being directed at and fracturing the target material).

[0059] As another example, the formation of bubbles during treatment can further move the stone away from the tip of the fiber (e.g., called backward movement), potentially increasing the distance between the distal end of the fiber and the target material, thereby making the treatment inefficient. Regardless of the cause of the undesirable change in distance (or non-ideal distance), determining the distance between the tissue and the distal end of the fiber (including ensuring a predetermined distance) can improve treatment efficiency (and allow the laser system or medical professional to act accordingly).

[0060] In some non-restrictive examples, a laser system can distinguish between different types of stones and differentiate between stones and tissue (e.g., soft tissue). In this way, the laser system can determine whether a treatment target is actually being targeted by the laser beam and determine specific laser operating parameters tailored to the treatment target (e.g., different treatment targets may require different laser operating parameters). For example, if the treatment target is a stone and the laser system determines that the laser beam is targeting tissue and not stone, the laser system (or the medical professional controlling the laser system) can then act accordingly (e.g., turn the laser, reduce the laser power, etc.). Alternatively, if the treatment target is a stone and the laser system determines that the laser beam is targeting the stone (and not the tissue), the laser system (or the medical professional) can then increase the laser power (frequency, pulse width, etc.), appropriately trusting that the laser beam is directed towards the stone. In another example, a laser system can determine whether a treatment target is a target substance or tissue, and if the treatment target is a target substance, it can determine the type of target substance. In this way, the laser system (or medical professional) can adjust the laser operating parameters (e.g., CW power, pulse peak power, pulse shape and pulse width, pulse interval, pulse frequency and average power of the laser light) based on the determination of the target material (or tissue) and its type. For example, different types of stones have different material properties (e.g., different hardnesses) and can benefit from different laser operating parameters. In particular, harder stones may require higher energy laser pulses, while softer stones may require lower energy laser pulses. Regardless of the treatment target, the ability to distinguish between stones (and their types) and tissues can reduce treatment time and improve treatment outcomes.

[0061] In some non-limiting examples, the laser system can provide information about whether the fiber is in contact with tissue and optimize the interaction mechanism between the laser light and the tissue for a desired effect (e.g., using the mechanical energy of bubbles (e.g., for separating the prostatic capsule and glandular tissue), using the thermomechanical energy emitted by the absorption of laser light, using the thermal energy emitted by the absorption of laser energy, etc.). For example, the laser system can be used to identify different types of tissue (e.g., prostatic capsule, glandular tissue, etc.), each of which may have a different desired predetermined distance from the distal tip of the fiber to the treatment target (tissue in this case), and which may have a different desired predetermined distance than a calculus. For example, the tissue may be at a predetermined distance between the distal tip of the fiber and the treatment target, i.e., the tissue may be in the range of 1 to 10 millimeters (e.g., this can enhance the mechanical effect of the tissue). As another example, the calculus (or tissue to be removed or coagulated) may have a predetermined distance between the distal tip of the fiber and the treatment target, ranging from 0 to 5 millimeters (for example, this may facilitate thermal ablation, thermomechanical ablation, etc., which can be used for tissue vaporization, incision, coagulation, etc.).

[0062] In some non-restrictive cases, a laser system can determine the position of the fiber tip to ensure proper fiber positioning within a scope (e.g., an endoscope). For example, if the fiber is located within the scope (e.g., behind the distal end of the scope) and the laser emits laser light, the laser light could damage components of the scope. Furthermore, if the distal end of the fiber is too far from the distal end of the scope (e.g., more than 4 mm), the fiber may be undesirably bent and damaged by mechanical pressure from the scope.

[0063] As previously mentioned, this scope may be any of the various surgical or other medical scopes, including specialized or special-purpose scopes. The scope may include an imaging system and / or camera for receiving images of the patient's internal region. Image data from the scope may be used in the integrated system described herein for analysis, control, and / or user feedback.

[0064] In some non-limiting examples, a laser system can determine the integrity of a fiber. For example, a laser system can determine if a fiber is cracked, bent, discolored, or broken. In another example, a laser system can determine if a fiber is curved beyond its curvature vector (for example, it can indicate that the fiber cannot properly guide the laser light so that it is emitted from its distal end).

[0065] In some non-limiting cases, including when tissue contact is desirable, laser systems can create bubbles in a controlled manner. For example, a laser system can generate a prepulse of laser light (e.g., not the treatment laser light) that forms controlled bubbles (and vapor channels, i.e., "Moses" channels). Correspondingly, the laser system can determine whether (and when) it will reach the stone or tissue material (e.g., the vapor channels that will contact the stone or other target) within these bubbles. In this way, the treatment laser light can be avoided until the vapor channels contact the stone, thereby allowing for better control of laser light delivery and reducing the backward displacement of the stone (e.g., improved visibility, better targeting of the treatment target, improved treatment efficiency, etc.). In some cases, this controlled bubble formation can be continuous even at the distal end of the fiber (e.g., the bubbles remain continuously present while the treatment laser light is delivered), thereby avoiding the uncontrolled evaporation of other water in the treatment area and increasing tissue ablation efficiency. In some configurations, such as using controlled bubbles continuously created at the distal end of the fiber, the laser system can control the laser so that the therapeutic laser light is only permitted when target tissue is detected, for example in the non-contact (popcorn) mode of lithotripsy (using the procedures described herein).

[0066] In some non-limiting cases, using light from a source other than the treatment laser is advantageous because the light from other sources does not undesirably interact with tissue, stones, etc. For example, advantageously, the light can have a lower power than the laser treatment light from the treatment laser.

[0067] Figure 1 is a schematic diagram of a non-limiting example of a smart laser system 100 according to an aspect of the present invention. As used herein, the term “smart” refers to the ability of one or more components of the laser system 100 to engage in bidirectional communication (i.e., transmit and / or receive signals) with one or more other components of the system, such as a controller or control system of the laser system 150. For example, a control system (described in more detail below) can control other components of the system, such as a laser driver 101 or a laser source 110, in response to signals corresponding to a patient and / or treatment area transmitted to the control system via one or more sensors (e.g., by changing laser operating parameters).

[0068] System 100 comprises a multifunctional optical adapter 105, a laser source 110 for generating therapeutic radiation, a laser driver 101, a control system 150 including a processor for performing smart functions, and a surgical optical fiber 145 which may be part of the laser system or a separate device. The laser driver 101 is a current and voltage source for laser pumping. For example, the laser driver 101 may be a driver for a diode laser or a flash lamp. A diode laser may be used for direct tissue treatment or for pumping solid or fiber lasers. A flash lamp may be used for pumping solid lasers. The laser source 110 generates laser radiation which is delivered to the optical adapter 105 via an optical fiber or free beam 140. The laser radiation is partially reflected by the optical adapter 105 for laser power monitoring and coupled to the surgical optical fiber 145. The laser radiation from the distal end of the surgical optical fiber 145 interacts with the therapeutic target in the surgical treatment environment 102 (i.e., treating tissue or stones). The optical adapter 105 is also connected to the source of the probe signal 130, for example, the probe light source (which is also the excitation light source), and one or more sensors 120 of electromagnetic radiation. The probe signal from the probe signal source 130 is also coupled (via the optical adapter 105) to the surgical optical fiber 145 and the return probe signal (also referred to herein as probe signal data), and other electromagnetic radiation generated in the surgical treatment environment may be partially deflected to the sensors 120 (via the optical adapter 105) for further reference and analysis.

[0069] During the interaction of surgical laser radiation with fluids in the treatment zone, such as biological tissues like baskets, stones, and / or surgical components, specific electromagnetic signals may be reflected or generated in response to excitation and propagated through the surgical optical fiber 145 to the optical adapter 105, which may further be directed to specific sensors 120. These electromagnetic signals may include probe signal data based on the source of the probe signal, and the electromagnetic signals may be directed to the sensors 120 (via the optical adapter 105). In some cases, these electromagnetic signals are reflected from structural non-uniformity of the surgical optical fiber 145 or special structures at the distal end of the fiber (e.g., Bragg grating, special shapes of the tip such as a fluorescent doped end or cone, unilateral bending, etc.). The control system 150 receives signals from the sensors 120 and performs analysis used in the control system 150 to control other components of the system, such as the laser driver 101 and the laser source 110. The laser source 110 may be any laser with parameters optimized for desired therapeutic effect and transmission through the surgical fiber 145. For example, in urological procedures such as lithotomy, silica fiber can be used as a laser source with wavelengths in the range of 1.85–2.2 μm, pulse energy of 0.001–10 J, peak power of 0.1–100 kW, and average power of 2–200 W. It may also be Ho:YAG, Tm:YAG, Tm:YLF, and other solid-state lasers with parameters such as a flash lamp or diode pump. Another example is a Tm fiber laser with a diode pump in free-running or Q-switched operating mode. This laser can also be used for soft tissue procedures. Furthermore, lasers with wavelengths of 400–600 nm may be used. For example, a diode laser with a second harmonic of an Nd:YAG laser with wavelengths of 400–460 nm, or 780–1100 nm, or 1300–2100 nm, or 530 nm may be used. Such lasers can operate in continuous wave (CW) mode at powers of 10–300 W. Diodes or diode pump lasers, such as fiber laser sources, may also be desirable in some configurations.

[0070] In another aspect of the present invention, the smart laser may be part of an integrated therapeutic system that, in addition to the laser system 100 and surgical fiber 145, may include an artificial intelligence (AI) managing a (flexible, semi-flexible, or rigid) scope 155, a suction, irrigation, or suction / irrigation subsystem 170, and a control center 151 (Figure 2). The AI ​​control center performs initial processing of signals from the imaging system 166 of the scope 167 and the suction / irrigation subsystem 170, and performs synchronization with the laser system 110 and laser driver 101. The scope 167 includes a handle with an imaging sensor 171, a rigid, semi-rigid, or flexible shaft 168, and an illumination source such as an LED or lamp 169 (a lamp with fiber delivery) with illumination emission from the distal end of the shaft. The AI-managed control center 151 may be integrated with the laser system controller 150, be a separate unit, or be integrated with the scope imaging system 166 with initial processing and control of the video sensor 171. Such an integrated system greatly extends the benefits of the smart laser for both the patient and the operator.

[0071] For example, according to one embodiment, the smart laser can receive and process visual information received by the video camera of the scope 169. This information can be used in combination with other information channels available to the system from sensor 120 (elastic scattering, fluorescence, etc.) and information on laser parameters from controller 150. This information can be used to detect and recognize various treatment conditions such as 1) detecting / identifying soft tissue and stones, 2) recognizing stone type and the underlying structure of the stone, 3) recognizing soft tissue type (e.g., capsule / glandular tissue boundary, detection / identification of tumor and normal tissue), 4) the distance between the tissue or stone and the distal end of the fiber, 5) tissue bleeding, 6) visualization quality of the surgical field that may be impaired by scattering light into ablation products, 7) backward displacement of the stone, 8) pop coning performance, 9) damage or contamination of the distal tip, 10) flash in the treatment area, and 11) recognition of the treatment organ.

[0072] The camera images can be further processed by an image processor 166 or an AI-managed control center. Image processing algorithms are developed, optimized, and validated for each clinical embodiment using clinical endoscopic video imaging and machine learning method analysis.

[0073] The use of information from the imaging system of the endoscope 166 further improves the accuracy of the measured distance to the target, distinguishes between stones and soft tissue, and identifies the type of stone or tissue. When the scope's LED is used for target illumination, the LED spectrum becomes available in real time at the control center, ensuring accurate dynamic normalization of the elastic / fluorescence spectrum (Figure 3D).

[0074] In another embodiment, the suction / wash subsystem may be provided with a set of pressure / flow sensors and temperature sensors that transmit measurements to an AI-controlled control center 151. This information can be used to: 1) measure the temperature of the suction and wash fluids to prevent overheating and damage to the tissue epithelium and deeper layers; 2) measure the fluid flow rate to calculate the temperature within the treatment organ, which is directly proportional to the laser output and inversely proportional to the fluid flow rate; and 3) measure the wash or suction pressure and its difference to prevent damage to the treatment organ due to excessively high positive pressure or excessively low negative pressure. The laser emission can then be synchronized with the flow rate and pressure ratio of the wash and / or suction pumps via signaling from the AI-controlled control center to achieve maximum clinical outcomes and safety. For example, the wash and suction pumps can operate in pulse mode and synchronize with the laser pulses to pulsate the wash, thereby improving the suction rate by achieving maximum clear visibility of the surgical target and maintaining a safe margin.

[0075] Real-time information from the imaging system 166 and sensor 120 can be integrated and processed in real time within the laser control system or AI-managed control system to enhance accuracy and combine and process for redundancy. For example, the distance between a stone or tissue and the distal fiber end can be measured by processing the back reference signal from the endoscope LED (see the "Use of Integrated Signals" section) or the image from the endoscope video system. If both signals are within acceptable limits, commands can be issued to enable or disable changes to laser emission or laser parameters within a predefined range.

[0076] The smart laser system (Figure 1) or the smart laser system integrated with an endoscope or other device of the proposed invention (Figure 2) is designed to operate in the following steps: The first step is to acquire signals from the surgical treatment environment 102 using signals from the surgical fiber 145 and sensor 120 or / or other devices such as the endoscopic imaging system 166 and cleaning / suction system 170. The second step is to process these signals to provide information about the surgical treatment environment or the surgical fiber and instruments in the surgical treatment environment. The third step is to send signals from the laser system control unit to the laser driver to automatically change the pumping current and / or voltage, and to adjust the interval of the laser pulse power, time profile and peak power, laser energy, laser pulse and repetition rate, and average laser power to achieve the desired clinical outcome. The fourth step is to evaluate the desired clinical outcome. The third step may, in certain cases, be to completely interrupt the laser energy delivery. In some embodiments, the third step may involve generating an auditory or visual signal for the operator with an optional coding of the color of a visual signal and / or the intensity of an auditory signal of different tones and intensities, accompanied by an intensity that prompts the operator to change the laser parameters. Step 4 is to evaluate the achieved clinical outcomes and decide whether to stop or continue the treatment.

[0077] Table 1 below is a non-limiting list of the types of features and functions provided by the disclosed system and method.

[0078] [Table 1]

[0079] Figure 3 shows a schematic diagram of the optical adapter 105, which is an example of the optical components of the optical adapter 105 that can easily direct light to and from different ports. For example, the optical adapter 105 may include beam splitters 214, 216, 218, 220 and lenses 222, 224. Each of the beam splitters 214, 216, 218, and 220 can be placed within the optical adapter 105 (e.g., the housing of the optical adapter 105) and each can be oriented in the same way (e.g., angled as shown in Figure 3). The angle between the axis of the laser beam and the normal to the beam splitter surface is in the range of 10 to 70 degrees, and depending on the application, 30 to 50 degrees is preferable. However, although four beam splitters are shown in the figure, other numbers of beam splitters can also be used, for example, especially if the number of port pairs is different. Therefore, in some cases, the number of beam splitters may coincide with the number of aligned ports on the optical adapter 105 (except for ports 162 and 164, for example). Furthermore, although all beam splitters 214, 216, 218, and 220 are shown as being oriented in the same direction, it should be understood that beam splitters 214, 216, 218, and 220 can be oriented in different ways, such that the direction of light between ports is altered by the orientation of the beam splitter. Each beam splitter is coated with a dielectric coating to maximize the transmittance of the laser beam and obtain optimal reflections across the spectral range of the probing beam, resulting in back-reflected signals associated with the ports connected to that beam splitter. In addition, some ports include lenses or sets of lenses that can re-image the proximal end of the surgical fiber 159 onto the detector.

[0080] As shown in Figure 3, a beam splitter 214 can be positioned (and aligned) between ports 166 and 174, another beam splitter 216 can be positioned (and aligned) between ports 168 and 176, another beam splitter 218 can be positioned (and aligned) between ports 170 and 178, and a further beam splitter 220 can be positioned (and aligned) between ports 172 and 180, with each of the beam splitters 214, 216, 218, and 220 being positioned (and aligned) between ports 162 and 164. Each of the beam splitters 214, 216, 218, and 220 can direct light to (and from) their respective ports 174, 176, 178, and 180, while each can transmit laser light through thereto to optical port 164 (and to surgical fiber 145). For example, light can be emitted into port 174 and directed by beam splitter 214 through optical port 164 to the proximal end of fiber 145, following direction 226 (e.g., extending from the proximal end to the distal end of fiber 145). As another example, light directed toward the distal end of fiber 145 along direction 228 (e.g., extending from the distal end to the proximal end of surgical fiber 145) can be emitted through port 164, pass through lens 224, and directed by beam splitter 220 through port 180.

[0081] In some non-limiting examples, lens 222 can communicate optically with the therapeutic laser 152 and may be positioned before port 162 in the optical adapter 105 behind each of the beam splitters 214, 216, 218, and 220. In some cases, lens 222 may be a collimating lens. In this way, the laser light can be collimated after passing through lens 222. In some non-limiting examples, lens 224 may be a focusing lens that can focus light passing through the focusing lens in direction 226 and diverge light passing through the focusing lens in direction 228. In some cases, lens 224 may be positioned behind port 164 and before each of the beam splitters 214, 216, 218, and 220 in the optical adapter 105.

[0082] In some non-limiting examples, lens 222 can communicate optically with the therapeutic laser described above. In some cases, lens 222 may be a collimating lens. In this way, the laser therapeutic light can be collimated after passing through lens 222. In some non-limiting examples, lens 224 may be a focusing lens that can focus the light passing through the focusing lens in direction 226 and diverge the light passing through the focusing lens in direction 228. In some cases, lens 224 may be located behind port 164 and before each of the beam splitters 214, 216, 218, 220 in the optical adapter 105.

[0083] Figure 4 shows a schematic diagram of Figure 1, but further includes an input device 262 and an output device 260. That is, the system described above with respect to Figure 1 can be adapted to include various user interfaces, such as a display which can form the output device 260, and various user controls or input devices which can form the user input 262.

[0084] Figure 5 shows a schematic diagram of the laser system 300, which may be a specific implementation of the laser system described above or other laser systems described herein. The laser system 300 may also include an optical adapter 105 (which may also be called an optical coupler, optical module, etc.), shown in Figure 3. A non-limiting list of components or features shown in Figure 3 that may be included in the optical adapter 105 includes at least one port, an inverse fiber combiner 381 (also shown in Figure 8), a laser power monitor 382, ​​a quartz block 383, a collimating lens 384, beam splitters 385a, 385b, a aiming light source 386, a focusing lens 387, a protective window 388, a coupling lens 389, a filter 390, and a fiber connector 391.

[0085] The optical adapter 305 may be a multifunctional component that can guide light along different optical paths. For example, the optical adapter 305 can use lenses 384 and 387 to direct laser radiation from the laser 310 to the surgical fiber 345. Furthermore, the optical adapter 305 can direct light to one or more detectors to monitor the temperature of the distal end of the surgical fiber or liquid, back reflections from target or non-target light, fluorescence, other light, etc., each of which can be an indicator of proper working conditions in the treatment area. In some cases, the light source can emit a visible laser beam (e.g., green light in Figure 5) as a targeting beam into the surgical fiber 345 using a beam splitter 385a. For example, a visible laser beam may be emitted towards the beam splitter 385a, which can guide the visible laser beam to be directed towards the proximal end of the surgical fiber 345.

[0086] In some non-limiting examples, the probe light from the probe light source 330 can be directed to the proximal end of the surgical fiber 345 using a reflecting prism or mirror NUMBER. The light transmitted from the distal end to the proximal end (and outward) and returned through the surgical fiber 345 can be separated using a beam splitter and additional beam splitters (not shown) and directed to a single-core or multi-core fiber (e.g., using a coupling lens to direct the light into the fiber), and this light can be delivered to one or more photodetectors. Furthermore, in some non-limiting examples, all photodetectors can be configured with spectral filters to select one or more desired wavelengths. In some non-limiting examples, one or more photodetectors can be configured as a spectrometer to measure the spectral distribution of this light (e.g., back-reflected light from the scope, broad-spectrum illumination sources such as LEDs, fluorescence, or thermal radiation).

[0087] Figure 6 shows a schematic diagram of laser system 301, and Figure 7 shows a schematic diagram of laser system 303, each of which may be a specific implementation of laser systems 100, 300, or others described herein. Each of laser systems 301, 303 includes an optical adapter 105 configured to direct light to a spectrometer. For example, light directed to the distal end of a surgical fiber 345 may be back-reflected from a target, or directed to fiber 392 (see Figure 6) and coupled to a detector such as a photodiode or spectrometer using a beam splitter 185b, which may be illumination light for the scope reflected from a target or thermal radiation for the distal fiber end or a heated treatment area. Optical data from the spectrometer is transferred to a computing device via cable 396. In some cases, light from the treatment area reflected from beam splitter 385b is coupled to fiber 380b at lens 389 and input to the fiber of an inverse fiber combiner 381. Some of the seven fibers of the inverse fiber combiner can be connected to the spectrometer 394, and the others can be connected to photodiodes. In some cases, this light directed to the distal end of the surgical fiber 345 may originate from the illumination light of the endoscope (e.g., this light is reflected and scattered by tissues, stones, particles, surgical components in the liquid environment of the treatment area) and may be broad-spectrum light (e.g., including multiple wavelengths in the range of 400 nm to 800 nm). In some cases, this light (e.g., light delivered to the treatment area via the surgical fiber and reflected back by tissues, stones, particles in the liquid environment of the treatment area, surgical components, etc.) may be broad-spectrum light originating from a probing light source configured to emit light having wavelengths in the range of 300 to 2700 nm. In some cases, this light may be broad-spectrum photothermal radiation generated in the treatment area in response to laser light (e.g., high-power laser radiation) and interacting with tissue, stones, surgical components, ablation products created by the interaction of laser light, or the distal end of a surgical fiber. In some configurations, this light may be fluorescence induced by a probing laser source, a broad-spectrum light source (e.g., an LED), a targeting beam, etc.In some cases, this light may be fluorescence generated from additional molecules or particles (e.g., fluorescent markers) delivered to the patient (e.g., during treatment) by means of a lavage solution or injection into the bloodstream. In some cases, this fluorescence may be induced by a probing light source (e.g., a probing laser source, LED, aiming beam, etc.).

[0088] Regardless of the configuration, this light (e.g., broad-spectrum light) can be directed to the spectrometer 394, thereby generating an optical spectrum that can be received by a computing device. In some cases, this optical spectrum can be analyzed using the computing device or the spectrometer 394 itself (e.g., using the signal processing electronics of the spectrometer 394). In some cases, an optical database of the spectrum may be received by the computing device via cable 396 based on the information provided by the analysis of the optical spectrum and may be used to generate auditory, visual, or other signals (such as control commands) to the laser system, to the user, or to determine (or change) laser operating parameters.

[0089] In some non-limiting examples, light (e.g., broad-spectrum light) can be delivered to the spectrometer 394 by fiber 192 (see Figure 6) or through one or more cores of the multicore fiber 381 (see Figure 7). In these non-limiting examples, other cores of the multicore fiber 381 can be used for other signal detection (e.g., photodetection). For example, other signal detection may include probing light reflected from tissue, stones, surgical parts, etc., and directed toward the distal end of the surgical fiber 345, and fluorescent light (without spectral resolution) also directed toward the distal end of the surgical fiber 345. In some cases, the central core of the multicore fiber 381 can be used to deliver light (e.g., monochromatic or broad-spectrum light) to the treatment area. For example, a light source coupled to the central fiber can travel through the coupling lens 189 and be directed toward the proximal end of the surgical fiber 345 by the beam splitter 385b and lens 189. In this case, a portion of this light may be back-reflected light, and may also be used in a similar manner to broad-spectrum endoscopic illumination light for detecting and distinguishing the type of tissue, stone, surgical component, ablation product, and other therapeutic characteristics based on analysis of the optical spectrum of the back-reflected (scattered) light, and compared with the optical spectrum of light emitted from a light source coupled to a central fiber.

[0090] With respect to the optical adapter 305, fiber 381 can be split into multiple optical channels, each consisting of its own photodetector (or light source). In some cases, functions responsible for critical operations can be split to ensure redundancy and reduce the risk of malfunction (for example, multiple optical channels sensing the same type of light, such as light of the same wavelength). This optical splitting can be further used to direct other probe light into the optical path defined by the surgical fiber 345. In some cases, a computing device can receive signals (such as data) from each optical detector and each spectrometer, which can be analyzed to determine system parameters and improve the efficiency and safety of treatment.

[0091] As shown in Figure 7, the spectrometer 394 can communicate optically with one or more optical channels of the multicore fiber 381 so that light from each optical channel can be directed to the spectrometer 394. In some cases, the multicore fiber 381 may include an inverse combiner (e.g., a tree coupler) that can couple the light from each optical channel so that it is directed through port 380d (and to the distal end of the surgical fiber 345). Correspondingly, the light from the proximal end of the surgical fiber 345 can be directed to the inverse combiner and can be divided (e.g., evenly) among each of the optical channels of the multicore fiber 381.

[0092] Figure 8 shows a cross-sectional view of the multicore fiber 381. As shown in Figure 8, the multicore fiber 381 contains multiple optical channels (for example, seven as shown), each optical channel being associated with a photodetector or light source. For example, in a first configuration, the first optical channel can communicate optically with a spectrometer, the second optical channel can communicate optically with a spectrometer (or another spectrometer), and the third, fourth, fifth, and sixth optical channels can communicate optically with their respective photodetectors. In some cases, the seventh optical channel can communicate optically with a light source.

[0093] In the second configuration, each of the first, second, third, fourth, and sixth optical channels can communicate optically with its respective photodetector (or light source). In some cases, the seventh optical channel can communicate optically with the light source. In the third configuration, the first and second optical channels can communicate optically with the first photodetector, the third and fourth optical channels can communicate optically with the second photodetector, and the fifth and sixth optical channels can communicate optically with the third photodetector.

[0094] In some configurations, each optical channel of the multicore fiber 381 can communicate optically with its respective light source and its respective photodetector. For example, each light source can emit light into its respective optical channel of the multicore fiber 318, while each photodetector can receive light from its respective optical channel. In some configurations, each optical channel of the multicore fiber 318 can include a beam splitter, each beam splitter facilitating the directing of light from its respective light source to its respective optical channel and the reception of light from its respective optical channel to its respective photodetector. In some cases, this configuration, with a light source and photodetector for each optical channel, can reduce the number of ports required for the optical adapter 305. In some cases, although a multicore fiber 381 is shown, the multicore fiber 381 can be replaced with multiple fibers. In this case, each of the multiple fibers corresponds to an optical channel of the multicore fiber 381.

[0095] In another, less restrictive example, fluorescence emission from tissues and stones can be used to identify the type of target and select optimal therapeutic parameters. Either fluorescence from endogenous chromophores (autofluorescence) or fluorescence from exogenous chromophores (inducible fluorescence) can be used for identification.

[0096] Figure 9 is a schematic diagram of a non-limiting example of a laser system 400 that uses fluorescence emission detection for control and treatment optimization. A fluorescence light source 437 (e.g., a laser or LED) (also referred to herein as an excitation light source) acts as a probe light source and is used to excite fluorescence. In a non-limiting example of autofluorescence, a preferred range of excitation wavelengths for the excitation light is 290 nm to 900 nm, more preferably 330 nm to 700 nm, and even more preferably 360 nm to 400 nm. In a non-limiting example of exogenous fluorescence, the excitation wavelength is selected based on the phosphor used.

[0097] The excitation light from the excitation source 437 can be directed to an optical fiber instrument, for example, a fiber, which is preferably the same fiber that transmits the therapeutic laser light from the laser source 410. The feedback light from the fluorescence emission can be transmitted through the same fiber 445 to detectors 446, 447, and spectrometer 448. At least one (preferably two or more) detectors, for example 446, 447, can be used to detect the fluorescence in different wavelength bands. In some cases, one or more of the detectors can be PIN photodiodes, APD photodiodes, photomultiplier tubes, etc. The control system 450 may include additional components that facilitate accurate signal acquisition, such as a lock-in amplifier and heterodyne electronics. Some non-limiting examples may include the use of a spectrometer to collect complete spectral fluorescence information. For example, the spectrometer 448 can receive the light emitted from the proximal end of the fiber 445, which is returned through the distal end of the fiber 445.

[0098] In some non-restrictive cases, the laser source 410 can emit continuous wave (CW) light. In non-restrictive cases of CW light, target identification is performed by at least one of (1) or (2). In case (1), the ratio of the fluorescence signal to the reflected excitation signal can be used. For example, the ratio of the fluorescence signal F to the reflected signal R (F / R) is expected to be higher for rock than for soft tissue, and if the F / R ratio exceeds a predetermined limit (e.g., 10) or a desired range, this means that the target is rock and not soft tissue (and vice versa). For (2), the ratio of two or more fluorescence signals measured in different wavelength bands can be used (e.g., the ratio of fluorescence signal F1 in the 400-500 nm band to fluorescence signal F2 in the 550-650 nm band). For example, the ratio of fluorescence signal F1 to fluorescence signal F2 is expected to be lower for rock than for soft tissue, and if F1 / F2 falls below a predetermined limit or range, this means that the target is rock and not soft tissue (and vice versa).

[0099] The selection of the appropriate wavelength band varies depending on the condition being treated. In lithotripsy applications, this selection is indicated by the fluorescence spectra of stones and soft tissues. Figure 10 shows the fluorescence responses (x-axis = wavelength, y-axis = normalized intensity) of two different types of biological materials, calcium oxalate monohydrate (COM) and human soft tissue (mucosa), using an excitation wavelength of 365 nm. Of note is the prominent feature at approximately 450 nm in the mucosa spectrum. This feature can be used to further enhance the distinction between stones and soft tissues.

[0100] In a further non-limiting example, the dynamic characteristics of a fluorescence signal can be measured by system 400. This can be achieved by pulsing or modulating the excitation source 437 and detecting the fluorescence signal (response) in the time or frequency domain to measure the fluorescence lifetime. From these measurements, the fluorescence lifetime can be determined. Target identification may be based on the contrast between the characteristics of the phosphor observed in the target region (e.g., a calculus) and the surrounding intact region (e.g., soft tissue) (e.g., the base difference of their respective fluorescence spectra or lifetimes). Fluorescence spectral analysis can be performed by spectrometer 448 or by measuring the signal in a predetermined spectral bandpass defined by a spectral filter.

[0101] In yet another non-limiting example, a polarized excitation light source 437 can be used to measure the polarization state of the fluorescence signal. In this case, the optical fiber instrument 445 consists of a polarization storage channel to accurately transmit the polarization state to the sensor. By analyzing the polarization state of the fluorescence signal, the fluorescence lifetime can be indirectly evaluated and the difference between the target region and the non-target region can be revealed.

[0102] Figure 11 shows graphs of the autofluorescence response (e.g., fluorescence spectrum) for three different types of stones (e.g., calcium oxyate monohydrate, struvite, and xanthine).

[0103] Figure 12 shows a schematic diagram of another example of a laser system 500 having a surgical fiber 545 and an endoscope 560. The laser system 500 can combine three types of light sources: a therapeutic laser, a pilot laser, and a probing light source. The light is distributed from the proximal end to the distal end of the surgical fiber 545 or guided in other ways. The surgical fiber 545 can be inserted into the endoscope 560 and may include a flexible component with a distal fiber tip. The end of the endoscope 560 can be directed towards the patient's organs 552 (e.g., urethra, bladder, ureters, kidneys, etc.). As shown in Figure 12, an illumination light source 564 (e.g., an LED light source) may be provided at the distal end of the shaft of the endoscope 560. This light source 564 can illuminate the surgical / operational field within the organ (or elsewhere in the patient). The endoscope 560 may include a video camera (imaging sensor) 562 that can convert real-time images of the surgical / operational field to an external monitor / screen and optionally to an image processor. Using one or more analyzed signals from cameras and smart sensor systems, physicians can guide surgical fibers along the urethra, bladder, ureters, and kidney channels to approach and locate targets such as stones that need to be fragmented or soft tissue (such as tumors) that need to be treated (vaporized, coagulated, or excised).

[0104] The probing light source can be any one of many different light sources, including narrow-spectrum or broad-spectrum LED light sources, and these light sources can have any number of different wavelength ranges, including wavelength ranges such as UV, visible, and near-IR ranges. In some non-limiting examples, the probing light source may also be a laser light source having any of many different wavelengths, including those that match the peak absorption of the target chromophore, such non-limiting examples include 400–450 nm, 500–600 nm, 940–1100 nm, 1150–1350 nm, 1400–1600 nm, and 1850–2200 nm. In some cases, these wavelengths may correspond to specific physiological characteristics. For example, 400–450 nm and 500–600 nm are associated with hemoglobin absorption, and since soft tissue contains hemoglobin and stones do not, they can be used to distinguish between tissue and stone material (e.g., tissue absorbs these wavelengths more than stones). In another example, 520–540 nm relates to a commonly used range of aiming beam wavelengths (see, for example, the aiming beam of the optical adapter in Figure 5), and the aiming beam can be used as a probing beam. In yet another example, 940–1000 nm, 1400–1600 nm, and 1850–2200 nm relate to peaks of water absorption (tissue contains more water than stone), while 400–940 nm or 1150–1350 nm relate to the opposite case of water transmission. Thus, these wavelengths may show different probing responses from stone and soft tissue and can be used to distinguish between these two types of physiological materials.

[0105] Figure 13 shows a table of specific functions of the laser system described herein (e.g., including determination of treatment conditions), and Figure 14 shows a more specific table of the table in Figure 13 (e.g., each function is described in more detail). Some of the other figures (and corresponding descriptions) provide information about these and other functions. For example, Figure 13 shows a non-limiting list of functions of the optical adapter of the laser system. Arrows indicate various combinations of diagnostic light sources and detectors. As shown in these figures (and others), organizing the elements of the optical adapter, and the associated multiple detectors, light sources, and probe signal data from the probe light sources, can perform a non-limiting list of “smart” functions listed herein to ensure a more efficient, safer, and faster overall treatment procedure with improved clinical outcomes. The systems described herein can be used whole or in part for multiple functions. For example, different probe signal data and different back-reflected signals can provide information about specific conditions within a particular surgical environment.

[0106] Figure 15A shows a flowchart of process 600 for determining whether the therapeutic target is a target substance or tissue. As described above, the target substance may be a stone or calculus, or other substance. The stone or calculus may be located in a target area such as the bladder, ureter, or kidney, or in the kidney or other part of the urinary system. Additionally or alternatively, the target substance may not be a stone or calculus, or may not be related to the kidney or urinary system, but may be a substance located elsewhere in the body or in another system of the body.

[0107] The procedure 600 can be performed using any of the laser systems described herein (e.g., laser system 100), and the procedure 600 can be performed using one or more computing devices (e.g., computing device 130) as needed. Furthermore, as described below, the procedure can utilize a robotic surgical system or, instead of robotic control, utilize clinician control.

[0108] In 602, process 600 may include the step of moving the fiber into a treatment area containing a therapeutic target (e.g., a target substance). In one non-limiting example, the fiber may be moved manually. In another non-limiting example, a computing device may move the fiber into a robotic surgical system and position the fiber in a desired location relative to the therapeutic target. In some cases, the computing device may include inserting the fiber into the tube of a medical scope and inserting the medical scope into the patient (e.g., with the fiber positioned inside it). In one example, insertion may be performed through the patient's urethra, whether manually or robotically. In other cases, a clinician or computing device may insert the shaft of the medical scope into the patient's treatment area and then insert the fiber into the working channel of the shaft of the medical scope until the distal end of the fiber is inserted through the shaft of the medical scope. This description is based on a computing device, but this is just one non-limiting example. Process 600 may include a healthcare professional or clinician controlling the system and medical scope, which includes positioning the slope and / or fiber on the patient and moving the fiber until the distal end of the fiber reaches the treatment area (e.g., at a predetermined distance from the treatment target).

[0109] In 604, the process 600 may include the step of a computing device (or medical professional) causing a light source to emit first light toward a treatment area. For example, the light source may emit first light toward the proximal end of a fiber, which can propagate through the fiber and radiate toward the treatment area toward the distal end of the fiber. In some cases, the light source may be located within or adjacent to the treatment area (e.g., coupled to a medical scope). In some cases, the first light may be light of a broad continuous spectrum, or the first light may include one or more wavelengths in the range substantially between 400 nm and substantially 750 nm. In some cases, the first light may be pulsed (e.g., having multiple pulses, each having a pulse width). In some cases, the first light may be white light (e.g., the first light source is configured to emit white light, such as a white LED). In some configurations, the first light may be coherent light (e.g., the light source is a laser source). In some cases, the first light may be non-therapeutic light (for example, first light that is not configured to induce a therapeutic response when directed at a target, which may include excision, coagulation, etc.). In some cases, the average power of the first light may be less than 100 mW. In this way, the first light does not interfere with the reception of some of the first light, thereby avoiding undesirable interactions with the therapeutic target that could interfere with the identification of the therapeutic target.

[0110] In 606, the process 600 may include the step of directing a portion of the first light to a photodetector. In some cases, the portion of the first light is sent back to the distal end of the fiber, propagates through the fiber, is emitted from the proximal end of the fiber, and directed to the detector (e.g., via an optical adapter). In some cases, the portion of the first light may pass through an optical filter before reaching the detector. Thus, for example, the process 600 may include filtering a portion of the first light by passing a portion of the first light through an optical filter that restricts the portion of the first light to wavelengths within a certain range (e.g., the visible light range). In some cases, the optical filter may communicate optically with an optical filter that can be located in a port of the optical adapter. In some configurations, the portion of the first light may be backscattered, backreflected, etc.

[0111] In 608, the process 600 may include a computing device that receives data from a photodetector. For example, the data may correspond to a portion of the first light that interacts with the photodetector (e.g., filtered). In some cases, the photodetector may be a spectrometer. In some cases, the data may include the intensity of one or more wavelengths of the portion of the first light. For example, one or more wavelengths may be in the range substantially between 350 nm and substantially between 750 nm, in the range substantially between 400 nm and substantially between 700 nm, etc. In some cases, the data may include a back-reflected light spectrum. In some cases, the computing device may normalize the data based on the emission spectrum of the light source (e.g., because the amplitude of the first light is not perfectly uniform across all wavelengths of the first light). In some cases, the computing device may filter the data (e.g., using a low-pass filter, high-pass filter, band-pass filter, band-stop filter) to remove or amplify one or more intensity values ​​(for one or more wavelengths within the wavelength range).

[0112] In 610, the process 600 may include a computing device that determines, based on optical data, that the therapeutic target is tissue or target material. The optical data is signals from an optical detector (photosensor). Examples include photodiodes, 1D or 2D matrices of photosensors (e.g., charge-coupled devices (CCDs)). 1D matrix optical data is generated by a spectrometer, and 2D data is generated by an imaging sensor. The optical data may represent current or voltage from the photodetector in analog or digital format and be later transmitted to the computing device.

[0113] A data profile, optical data profile, or optical data time profile can refer to data or optical data as a function of time. A data profile can be a single optical data profile from a single detector, or a matrix of optical data profiles from a 1D or 2D matrix of optical sensors. Also, as will be discussed later, a characteristic optical data profile or characteristic optical data time profile can refer to stored / known data as a function of time, thereby making the underlying material or material properties that generated the profile known, for example, as a predefined calibrated or preset profile. For this purpose, a characteristic data profile can be used to identify the data profile in the target environment during a clinical procedure. That is, as will be discussed later, the data profile can be used to control the therapeutic laser during treatment by comparing it with a characteristic data profile.

[0114] For example, a computing device can use data to analyze the intensity of light at a selected wavelength or multiple wavelengths, for instance, by comparing an optical data profile with a characteristic data profile or other criteria, and based on that comparison, it can determine that the therapeutic target is a tissue or target substance. In a more specific example, a computing device can analyze the intensity profile of an optical signal acquired by a detector and compare this detected optical profile with a characteristic optical data profile that serves as a criterion for determining that the therapeutic target is a target substance.

[0115] As will be further explained, a data profile, optical data profile, or optical data time profile can refer to data or optical data as a function of time. A data profile is a single optical data profile from a single detector, or a matrix of optical data profiles from a 1D or 2D matrix of an optical sensor. As will also be explained, a characteristic optical data profile or property may refer to stored / known data as a function of time, thereby the underlying material or material property that generated the profile is known, for example, as a predefined calibrated or preset profile. For this purpose, a characteristic data profile can be used to identify the data profile in the target environment during a clinical procedure. That is, as will be discussed later, the data profile can be used to control the therapeutic laser in comparison to a characteristic data profile during treatment.

[0116] Furthermore, such data profiles can be used as characteristic criteria. For the purposes of this application, “characteristic criteria” may mean a previously generated optical data profile associated with a specific analytical conclusion based on preclinical or clinical collection studies stored in a computing device. Such characteristic criteria may be substantially transient, as described with respect to Figure 15B, which provides a signal profile for reflecting light indicating the stone or tissue being targeted, or they may be based on absolute or relative units, such as spectral profiles seen in Figures 16, 17, and 18, which identify the type of tissue and stone.

[0117] Referring to Figure 15B, a graph is provided showing an example of an optical data profile for use in the laser treatment described above. The data or optical data collected from the detector receives reflected light or probing light (target area) from the illumination source of the surgical scope from the surgical environment (target area). The intensity or output of the backreflected light changes continuously during treatment and exhibits different levels and time behavior depending on the position of the distal end of the fiber and scope relative to the target and non-target material and the laser operation. When the distal end of the fiber is far from the target, which can be 1 to several millimeters (time intervals 1701 and 1702), the level of backreflected light 1717 is low, indicating scattering from the entire environment, including liquid and the walls of the organ being treated. When the surgeon operates the laser at this fiber and scope position, bubbles form and collapse at the distal end of the surgical fiber, and the corresponding backreflected light is scattered into these bubbles at interval 1702, causing the backreflected signal to oscillate. As the fiber approaches the stone surface at 1703 (approximately 1-2 mm), the intensity of the backreflected light increases towards the maximum level achieved at 1704 when contact with the stone is made. In particular, the amplitude and irregularity of the vibration may also increase simultaneously due to additional backreflections of light caused by the products of stone ablation. During 1705, the distal end of the fiber loses contact with the stone. Upon loss of contact with the stone, the backreflected signal decreases towards a level similar to that before contact with the stone at interval 1706, as shown at 1705. As the surgeon moves the fiber toward soft tissue such as the ureteral wall, the backreflected signal increases to the maximum level achieved at interval 1707 when contact with soft tissue is made, and the amplitude of the vibration increases at 1708. As will be discussed later, determining such a data profile allows either the surgeon or the system to disable the laser source, reduce the laser power, adjust the energy or the interval between pulses, etc. This continues until the backreflected signal decreases to a level typical of backreflections from the tissue.

[0118] During this time, the control system compares this optical data profile with the characteristic optical data profile in real time. Several criteria may be used for the comparison. For example, signal levels 1717 and 1718 can be compared with known non-contact and contact levels for contact with or non-contact with the target, with or without therapeutic laser operation. Furthermore, statistics related to the average level 1711, 1714, maximum 1712, 1712, 1716, minimum level 1713, 1716, interval between vibrations 1718, vibration length, time interval, and vibration amplitude may be evaluated. Thus, the characteristic or known optical data profile or its important attributes are processed or compared against optical data profiles collected in preclinical or clinical studies in different surgical treatment environments. The computing device (control system) compares the optical data profile with the characteristic optical data profile in real time using one or more criteria.

[0119] Additionally or alternatively, the computing device can determine the integrated intensity by determining the region below the optical back reflection spectrum within a wavelength range (e.g., 540 nm to 590 nm), or by summing together the intensity values ​​for each wavelength of data within the wavelength range. The computing device can then determine that the therapeutic target is a target substance based on whether the integrated intensity value is greater than a reference value, or that the therapeutic target is a tissue based on whether the integrated intensity value is less than a reference value.

[0120] In some cases, such as when the data includes absorbance spectra, the computing device can compare the optical backreflection spectrum to a first predetermined optical backreflection spectrum associated with the target substance (e.g., the average of several optical backreflection spectra obtained from different stones) and a second predetermined or characteristic optical backreflection spectrum associated with the tissue (e.g., the average of several optical backreflection spectra obtained from different tissues). The computing device can then determine which of the first or second predetermined optical backreflection spectra the optical backreflection spectrum more closely matches, and accordingly determine that the therapeutic target is the target substance (based on the optical backreflection spectrum being closer to the first predetermined optical backreflection spectrum) or that the therapeutic target is the tissue (based on the optical backreflection spectrum being closer to the second predetermined optical backreflection spectrum). In some cases, this matching may include the computing device determining the amount of overlap between each of the two optical backreflection spectra.

[0121] In 612, the process 600 may include a computing device that, for example, determines the type of target substance of a therapeutic target (e.g., urinary stones, calcium oxalate monohydrate stones, cysteine ​​stones, etc.) based on the data after the computing device has determined that it is a target substance of a therapeutic target. In some cases, the computing device may determine the type of target substance from several possible types of target substances by following a similar process in block 610. For example, the computing device may compare a wavelength profile or intensity value to a reference value and determine the type of target substance based on the comparison with the characteristic profile or intensity. In another example, the computing device may compare an integrated intensity value to a reference and determine the type of target substance based on the comparison. In some cases, the computing device may determine the type of target substance based on comparing the intensity profile of the data to a characteristic profile. Additionally or alternatively, the computing device may compare the amplitude of a wavelength to one or more reference values. For example, the computing device may determine that the target substance is urinary stones based on the fact that the amplitude (or integrated intensity value) of a selected wavelength of data is greater than a first criterion and a second criterion, where the second criterion is greater than the first criterion. As another example, a computing device may determine that the target substance is calcium oxalate monohydrate based on the fact that the amplitude (or integrated intensity value) of the data's wavelength is between a first criterion and a second criterion. As yet another example, a computing device may determine that the target substance is cysteine ​​based on the fact that the amplitude (or integrated intensity value) of the data's wavelength is below both the first and second criterion.

[0122] In 614, the process 600 may include a computing device that determines the distance between the distal end of the fiber and the therapeutic target based on the determined therapeutic target. For example, different types or characteristics of therapeutic targets (e.g., size) may have corresponding predetermined desired distances associated with them (e.g., stored in a database). In a more specific example, the computing device may receive predetermined distances associated with the determined therapeutic target or target characteristics such as size (e.g., in a database). For example, the computing device may receive predetermined distances of a therapeutic target corresponding to a target substance (and / or the size of the target substance) based on the computing device's determination that the therapeutic target is a target substance (and type of target substance). Accordingly, the computing device may receive predetermined distances of a therapeutic target corresponding to a tissue based on the computing device's determination that the therapeutic target is tissue. In some cases, this may be advantageous in that the predetermined distance can be optimized for a particular therapeutic target. For example, a therapeutic target that is tissue may be desired to be further away than a stone (e.g., stones benefit more from a laser beam focal point closer to the stone, corresponding to better ablation performance, while tissue benefits more from a more dispersed laser beam, corresponding to better coagulation). Furthermore, harder types of stones, in contrast to softer stones, can be benefited from shorter distances (for example, by directing a more focused laser beam towards harder stones). Therefore, for example, if the treatment target is determined to be a target substance, the distance may be smaller than a predetermined distance for tissue, and if the treatment target is determined to be tissue, the distance may be larger than a predetermined distance for tissue. Correspondingly, if the treatment target is determined to be a target substance with hard material properties, the distance may be less than a predetermined distance for a target substance with softer material properties than for a hard material.

[0123] In 616, the process 600 may include a computing device that determines the laser operating parameters of a therapeutic laser based on the analysis described above. In some cases, the laser operating parameters may include pulse peak power, pulse shape, pulse width of the laser light emitted by the therapeutic laser, interval between pulses, frequency of the laser light, power output of the laser light (e.g., average power), and total duration of the laser light. In some cases, the computing device may receive one or more predetermined laser operating parameters for a therapeutic target corresponding to a target substance (and type of target substance) based on the computing device's determination that the therapeutic target is a target substance (and type of target substance). In other cases, the computing device may receive one or more predetermined laser operating parameters for a therapeutic target corresponding to a tissue based on the computing device's determination that the therapeutic target is tissue. In some non-limiting examples, having predetermined laser operating parameters may be advantageous in that the predetermined laser operating parameters can be tailored to a particular therapeutic target and its type. For example, tissue may benefit more from CW power operation than from a stone in the case of pulsed operation at high peak power (e.g., a larger amount of laser light directed at a stone may be advantageous for fragmenting the target substance). Therefore, one or more predetermined laser operating parameters for tissue may be lower than one or more predetermined laser operating parameters for stones (and vice versa). Similarly, one or more predetermined laser operating parameters for a first type of stone may be higher than one or more predetermined laser operating parameters for a second type of stone (for example, a first type of stone is harder than a second type of stone).

[0124] In some non-limiting examples, block 616 may include a computing device that notifies a healthcare professional based on the results of one or more determinations. For example, the computing device may display the results of the determinations from block 610 on a laser system or endoscopic image display, which may include displaying on the display that the therapeutic target is a target substance (and its type) or that the therapeutic target is tissue. Furthermore, the computing device may display on the display a determined distance (e.g., a predetermined distance) related to the therapeutic target, or determined laser dynamic parameters related to the therapeutic target.

[0125] In some non-limiting examples, the therapeutic target is already determined to be tissue or target material (and its type). In this case, for example, process 600 can be used to determine whether the current therapeutic target (e.g., in front of the distal end of the fiber) matches a predetermined therapeutic target. In this case, the computing device can determine whether the current therapeutic target (e.g., determined in blocks 610, 612) corresponds to or does not correspond to a predetermined therapeutic target. If the computing device determines that the current therapeutic target matches a predetermined therapeutic target, it can then control the operation of the therapeutic laser (including, for example, enabling the firing of the therapeutic laser, causing the therapeutic laser to emit laser light, increasing one or more laser operating parameters to make the therapeutic laser work). However, if the computing device determines that the current therapeutic target does not match a predetermined therapeutic target (e.g., the predetermined therapeutic target is a stone and the current therapeutic target is tissue), it can then control the operation of the therapeutic laser (including, for example, disabling the firing of the therapeutic laser, stopping the therapeutic laser from emitting laser light, changing one or more laser operating parameters). Furthermore, if the computing device determines that the current treatment target does not match a predetermined treatment target, it can alert the medical professional, for example, by displaying a warning on the display, flashing, or emitting a sound. In this way, during laser treatment, the computing device can adjust the operation of the treatment laser in real time if the current treatment target is not the actual predetermined treatment target, thereby preventing undesirable laser firing and improving treatment efficiency and safety.

[0126] In some non-limiting examples, stones may be identified as target material relative to tissue because they may reflect, scatter, etc., more light than tissue, particularly within specific wavelength ranges (e.g., the wavelength ranges of 410nm–460nm and 550nm–590nm), as tissue absorbs light within a wavelength range (e.g., hemoglobin absorbs light). For example, Figure 16 is a graph showing examples of backreflected light spectra of scope light LED illumination from various types of stones and kidney tissue, as shown in Figure 12, including backreflected light (reflection and scattering from the surface of the stone or tissue, backscattering from bulk stone or tissue, etc.). The backreflected light propagated through the surgical fiber is directed to another fiber connected to a spectrometer (Thorlabs Inc., CCS100 / M350–700nm) using the configuration shown in Figure 6 (e.g., the light is guided by a beam splitter via a lens). The core diameter of the surgical fiber is 0.2 mm and it extends 3 mm from the tip of the ureteroscope. The distance between the tip of the surgical fiber and the surface of the stone or tissue was approximately 1 mm. Analysis of the spectra shown in Figure 16 revealed substantial differences between the spectra of various stone types (COM, uric acid, cysteine, etc.) and between the spectra of stones and soft tissue. Different stone types have different levels of reflectance across all wavelength ranges. Soft tissue has a specific minimum in the 540-590 nm range, which can be used for soft tissue identification.

[0127] Figure 17 is a graph showing examples of the same spectra of back-reflected / scattered LED light from stone and soft tissue, normalized to the original LED spectrum. These spectra can be used to identify different types of stone and soft tissue. The distinction between different types of stone and soft tissue can be identified by spectral analysis (e.g., by distinguishing or integrating spectral curves across all regions or the most sensitive spectral range). This information can be used to identify the stone or type of stone and soft tissue before applying laser energy.

[0128] Figure 18, a table, shows the integrated reflection / scatter spectra of endoscopic LED signals from stones and soft tissues in different spectral ranges. The table shows examples of integrated back-reflected LED signals from stones and soft tissues in different wavelength ranges, namely the entire range of 410–700 nm, the blue range of 410–460 nm, and the green–yellow range of 510–620 nm, 410–430 nm, and the preferred narrow range of 550–590 nm. The type of tissue (hard or soft tissue) and the type of stone (e.g., the exact type of stone) can be identified by the integrated signals in the above wavelength ranges. For example, during laser treatment of kidney stones in the ureter, the surgeon needs to maintain contact with the stone at the distal end of the surgical fiber. However, if the surgeon accidentally loses contact with the stone and continues firing while touching the ureteral wall, it can perforate the wall with unacceptable side effects, potentially requiring open surgical intervention. These experiments showed a surprisingly high difference (2–4 times depending on the type of stone) between the back-reflected signals from stones and soft tissues. If the posterior reflection signal decreases by more than 1.2 to 1.7 times during treatment, the laser system may send an audible and / or visual warning signal to the surgeon to stop firing, or the laser system may automatically stop the laser treatment.

[0129] Figure 19 is a graph showing an example of the reflected / scattered LED light spectrum from a stone, separated (normalized) by the spectrum of back-reflected LED light from soft tissue. Variations of this ratio can be used to distinguish between stone and soft tissue.

[0130] Figure 20 shows a flowchart of process 650 for determining that a particular therapeutic target is a target substance and not an undesirable target such as healthy tissue. Process 650 can be implemented using the laser system described herein (e.g., laser system 100), and process 650 can be implemented using one or more computing devices (e.g., computing devices) as needed.

[0131] In another non-limiting example, the acoustic signals induced in a culture medium by the absorption of laser energy pulses can be used in a laser system to identify the type of therapeutic target (e.g., tissue versus target material). Furthermore, laser-induced acoustic signals can be used to detect and monitor the formation of bubbles in the culture medium. The acoustic signatures of different tissue types and stones may differ from one another due to differences in chemical composition and geometric structure, and due to differences in the acoustic signals of laser light absorption and the results during ablation; this information can be used by the laser system to distinguish these types of materials. The therapeutic target can be identified using either or both the intensity and spectral characteristics of the photoacoustic signal. The acquired (received) acoustic signals can be used to notify the operator and can be used in a computing device to control the pulses of the processing laser.

[0132] The acoustic signal can be acquired or received by an acoustic receiver, such as a microphone, positioned at one of the following locations: the distal tip of the scope's shaft as an independent tool within the scope's working channel, or an acoustic receiver attached to the patient's skin in close proximity to the treatment area. The acoustic signal can be induced using either the laser used for treatment or a specially introduced probe laser light source. According to one non-limiting example, the pulse width range used for this purpose is between 1 ns and 20 milliseconds, and the acoustic frequency range received is between 10 Hz and 50,000 Hz.

[0133] In 652, process 650 may include a computing device that moves a fiber to a therapeutic region containing a therapeutic target similar to block 602 of process 600.

[0134] In 654, the process 650 may include a computing device in which the processing laser emits laser light toward a treatment area (e.g., a treatment target). This may include the laser light being emitted from the proximal end of a fiber, propagating along the fiber, and being emitted from the distal end of the fiber toward the treatment area. In some cases, the processing laser may emit laser light according to one or more laser operating parameters. In some cases, the laser light may be pulsed (e.g., the laser light includes one or more pulses separated from each other). Block 654 describes the laser light being directed toward a treatment target, but in other configurations, the computing device may cause a light source to emit light toward a treatment target (the laser light may be different from the treatment laser, for example, with less power than the laser light from the treatment laser).

[0135] In 656, the process 650 may include the generation of sound waves based on the interaction between laser light (or light from a light source) and a therapeutic target. In 658, the process 650 may include a computing device that receives acoustic data from an acoustic transducer corresponding to sound waves interacting with the acoustic transducer. In some cases, the computing device may filter the acoustic data (for example, by passing the acoustic data to a filter to reduce or amplify the acoustic intensity values).

[0136] In 660, the process 650 may include a computing device that determines that the therapeutic target is a tissue or target substance based on acoustic data. Block 660 is similar to block 610, except that it can analyze acoustic data rather than data to be analyzed. Thus, the acoustic data can be analyzed in a similar manner to the analysis of data in block 610. For example, the computing device can compare the intensity values ​​of frequencies in the acoustic data to an intensity value criterion and determine that the therapeutic target is a tissue or target substance based on the comparison. In a more specific example, the computing device can compare the intensity values ​​of frequencies in the acoustic data to an intensity value criterion and determine that the therapeutic target is a target substance based on whether the intensity value is greater than the intensity value criterion, or whether the therapeutic target is a tissue based on whether the intensity value is less than the intensity value criterion.

[0137] In some cases, a more robust approach to determining whether a therapeutic target is a tissue or a target substance may involve a computing device determining an integrated intensity value from acoustic data. For example, the computing device may determine the integrated intensity by determining the area under the acoustic spectrum within a frequency range (e.g., from 10 Hz to 10 kHz) or by summing the individual intensity values ​​for each frequency of the acoustic data within the frequency range. The computing device may then determine that the therapeutic target is a target substance based on whether the integrated intensity value is greater than a criterion, or that the therapeutic target is a tissue based on whether the integrated intensity value is less than a criterion.

[0138] The acoustic data includes cases where acoustic spectra are included, and optionally, the computing device may compare the acoustic spectrum to a first predetermined acoustic spectrum associated with the target substance (e.g., the average of several acoustic spectra obtained from different stones) or to a second predetermined acoustic spectrum associated with the tissue (e.g., the average of several acoustic spectra obtained from different tissues). The computing device can then determine which of the first or second predetermined acoustic spectra the light absorption spectrum more closely matches, and accordingly, it can determine that the therapeutic target is the target substance (based on the acoustic spectrum being close to the first predetermined acoustic spectrum) or that the therapeutic target is the tissue (based on the acoustic spectrum being close to the second predetermined acoustic spectrum). Optionally, this match may include a computing device that determines the amount of overlap between each of the two acoustic spectra.

[0139] In 662, process 650 may include, for example, a computing device that determines the type of target substance based on acoustic data after the therapeutic target has been determined to be a target substance. This is similar to block 612 of process 600, except that acoustic data is used in the computing device instead of data (but using, for example, the same determination step in block 612).

[0140] In some non-limiting examples, the computing device can determine the distance between the distal end of the fiber and the therapeutic target based on the determined therapeutic target (and its type), in a manner similar to that of block 614 of process 600.

[0141] In 664, the process 650 may include a computing device that determines the state of a therapeutic target based on acoustic data. For example, the computing device can determine that a therapeutic target (e.g., determined to be a target substance) is ablated, carbonized, or coagulated based on whether the amplitude of one or more frequencies of the acoustic data exceeds (e.g., is greater than) a criterion associated with each state (e.g., ablated, carbonized, coagulated, etc.).

[0142] In 666, process 650 may include a computing device for determining the presence of bubbles (e.g., at the distal end of a fiber, a therapeutic target, etc.). In some cases, the acoustic spectrum in the presence of bubbles differs from the acoustic spectrum in the absence of bubbles. In some cases, determining the presence (or absence) of bubbles may follow a process similar to that in blocks 610, 612, 660, and 662. For example, the computing device may compare each amplitude of one or more frequencies of acoustic data to a reference (or more references) and determine the presence (or absence) of bubbles based on whether each amplitude exceeds the reference. The presence of bubbles can be identified based on the amplitude of an acoustic signal at a frequency corresponding to the frequency of the laser pulse that induces the bubbles. For example, an increase in the amplitude of an acoustic signal above a certain threshold (e.g., 10 times higher than the background signal) may indicate the start of bubble formation. The frequency range is preferably between 10 Hz and 10 kHz.

[0143] In 668, process 650 may include a computing device determining laser operating parameters of a therapeutic laser (for example, to emit laser light on a therapeutic target) based on the determined therapeutic target, the presence (or absence) of bubbles, etc. This may be similar to block 616 of process 650. Furthermore, block 666 may include notifying a healthcare professional based on the results of one or more determinations, similar to block 616 of process 650.

[0144] In some non-limiting examples, similar to process 600, the therapeutic target may be predetermined to be the tissue or target substance (and its type) of process 650. In this case, the computing device may determine that the current therapeutic target (e.g., before the distal end of the fiber), which can be determined in blocks 610, 612, matches (or does not match) a predetermined therapeutic target. This result can then be used to direct various adjustments, notifications, alarms, etc., in a manner similar to that of process 600.

[0145] Figures 21 and 22 collectively show flowcharts of process 700 for determining the distance between the distal end of the fiber and the therapeutic target. Process 700 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 700 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0146] In 702, process 700 may include a computing device that moves the fiber to a therapeutic area containing a therapeutic target, which may be the same as block 602 of process 600. In 704, process 700 may include a computing device that causes a light source to emit first light toward the therapeutic area according to a calibration procedure which may be the same as block 604 of process 600. In 706, process 700 may include a computing device that causes a therapeutic laser to emit laser light toward the therapeutic area according to a calibration procedure which may be the same as block 654 of process 650. In some cases, the calibrated laser light may have laser pulses, and the first light may have one or more pulses (e.g., three pulses). In some cases, the first pulse of the first light may be emitted before the laser pulse (for example, the first light is emitted before the leading edge of the laser pulse), the second pulse of the first light may be emitted during the emission of the laser pulse (for example, the second pulse is located between the rising edge and the falling edge of the laser pulse), and the third pulse of the first light may be emitted after the emission of the laser light (for example, after the trailing edge of the laser pulse). An example of this configuration is shown in the upper region of Figure 23, where the first light is a probing light source (light), and the first, second, and third pulses of the first light correspond to pulse A, pulse B, and pulse C, respectively.

[0147] In some non-limiting examples, the first light may be emitted sequentially before, during, and after the emission of the laser pulse. For example, the first light may include a first pulse that can be emitted before, during, and after the emission of the laser pulse. An example of this configuration is shown in the lower region of Figure 23, where the first light is a propulsion source (light) emitted before, during, and after the laser pulse.

[0148] Referring again to Figure 21, in block 708, process 700 may include the step of directing a portion of the first light to a photodetector, which may be similar to block 606 of process 600. In block 710, process 700 may include a computing device that receives first data from a photodetector, which can correspond to a (e.g., filtered) portion of the first light interacting with the photodetector. Block 710 may be similar to block 608 of process 600. In some configurations, the portion of the first light directed to the photodetector to generate the first data may be returned to the distal end of the fiber and emitted to the photodetector from the proximal end of the fiber. The portion of the first light may correspond to one or more sections of the first light, including a first section emitted before the laser pulse, a second section emitted during the laser pulse, and a third section emitted after the laser pulse.

[0149] In 712, the process 700 may include the computing device determining one or more calibration values ​​based on first data (which may be filtered, for example). In some cases, the data may include one or more first intensity values ​​corresponding to first light emitted before a laser pulse (e.g., a first section of a portion of the first light), one or more second intensity values ​​corresponding to first light emitted during the emission of the laser pulse (e.g., a second section of a portion of the first light), and one or more third intensity values ​​corresponding to first light emitted after the emission of the laser pulse (e.g., a third section of a portion of the first light). In some non-limiting examples, the computing device may determine a first calibration value from one or more first intensity values ​​(e.g., by averaging them), a second calibration value from one or more second intensity values ​​(e.g., by averaging them together), and a third calibration value from one or more third intensity values ​​(e.g., by averaging them). Each calibration value can be used to determine distance more accurately. For example, one or more first, second, and third intensity values ​​each correspond to different states of the treatment area. That is, one or more first intensity values ​​may correspond to a treatment area without bubbles (e.g., the distal end of the fiber), one or more second intensity values ​​may correspond to a treatment area containing bubbles (e.g., the distal end of the fiber), and one or more third intensity values ​​may correspond to a treatment area containing vapor channels through bubbles. In this way, distance determination can be made more accurate depending on the relationship between the emission of subsequent light and the emission of subsequent laser light over time.

[0150] In block 714, process 700 may include a computing device for moving the fiber to the treatment area. In some cases, this may include a computing device for moving the distal end of the fiber to a predetermined distance relative to the treatment target (e.g., using processes 600, 650). Block 714 may be similar to block 702.

[0151] In 716, process 700 may include a computing device that causes the therapeutic laser to emit a second laser beam toward the treatment area, and may be similar to block 654 of process 650. In some cases, block 716 can be omitted, for example, if the therapeutic laser emits the laser beam only after determining the distance.

[0152] In 718, the process 700 may include a computing device that causes a light source (or a different light source) to emit a second light toward the treatment area, and may be similar to block 704. In some cases, using the same light source has the advantage that the calibration procedure can be tailored to a particular light source.

[0153] In 720, the process 700 may include the step of directing a portion of the second light (e.g., which may be filtered) to a photodetector (or a different photodetector), which may be similar to block 708. In 722, the process 700 may include a computing device that receives (and filters) the second data from the photodetector (or a different photodetector), which may be similar to block 710.

[0154] In 724, the process 700 may include a computing device that determines the distance between the distal end of the fiber and the therapeutic target based on the second data (and one or more of the calibration values). In some cases, the computing device can compare the intensity values ​​from the second data with a curve that correlates the intensity values ​​with the distance (from the distal end of the fiber to the therapeutic target). In some cases, the curve may be correlated with the type of therapeutic target (e.g., target material (and corresponding type) or tissue). In some cases, the computing device can calibrate the second data by applying one or more (e.g., a combination) of the first, second, or third calibration values ​​to each intensity value of the second data, depending on when the second data was acquired for the second laser beam (if applicable). For example, if the second laser beam was not irradiated at all, or after the second laser beam was emitted, before emission, or while not emitted, then the first calibration value can be applied to the second data (e.g., each intensity value of the second data). In some cases, the step of calibrating the second data may include subtracting each intensity value of the second data from the first calibration value and dividing by the first calibration value. In other words, the step of calibrating the second data may include determining the relative change between each intensity value of the second data and the first calibration value.

[0155] In some configurations, determining the distance between the distal end of the fiber and the therapeutic target in block 726 may involve repeating blocks 718–722 to cause a light source (or another light source) to emit a third light that can be directed to a photodetector (or another photodetector) to generate a third data that can be received by a computing device. In this case, the computing device can determine the change between the intensity value of the third data (e.g., calibrated according to one or more calibration values) and the intensity value of the second data (e.g., calibrated according to one or more calibration values) (e.g., by subtracting the data). The computing device can then compare the change in intensity value to a curve relating the derivative of the intensity value to the distance (from the distal end of the fiber to the therapeutic target). In some cases, using the change in intensity value may provide a more robust method for determining the distance.

[0156] In 726, the process may include a computing device notifying a healthcare professional based on the results from one or more determinations and displaying the results. Block 726 may be similar to block 616 of process 600. In some cases, this may include a computing device that displays the distance on a display.

[0157] In some non-limiting cases, if a predetermined distance has already been determined or received by the computing device, the distance determined in block 724 may be the current distance. In this case, the computing device may determine the difference between the current distance and the predetermined distance and display the difference on a display (or otherwise notify the healthcare professional of the difference). In some cases, if the computing device determines that the current distance exceeds the predetermined distance, the computing device may then control the operation of the therapeutic laser (e.g., including enabling the therapeutic laser to fire, causing the therapeutic laser to emit laser light, or increasing one or more laser operating parameters to make the therapeutic laser work). However, if the computing device determines that the current distance does not exceed the predetermined distance, the computing device may then control the operation of the therapeutic laser (e.g., including disabling the therapeutic laser to fire, stopping the therapeutic laser from emitting laser light, or decreasing one or more laser operating parameters). Furthermore, if the computing device determines that the current distance exceeds the predetermined distance, the computing device may warn the healthcare professional, for example, by displaying a warning on a display. In this way, during laser treatment, the computing device can adjust the operation of the therapeutic laser in real time if the current distance deviates from a predetermined distance, thereby preventing undesirable laser firing or improving treatment efficiency. For example, sometimes the target material moves during laser treatment (e.g., known as backward movement), in which case the distance between the distal end of the fiber and the treatment target is determined so that the tissue does not receive undesirable treatment with the laser light (e.g., the computing device may stop firing the therapeutic laser). As another example, while the target material is broken into pieces and floats in the urine or "popcorn" after floating, the therapeutic laser may not always be in the same position as each of these particles.Therefore, if the particle is close enough to the distal end of the fiber, the computing device can fire a therapeutic laser, which creates an automated firing procedure so that the particle gets close enough to the distal end of the fiber, even if the image from the medical scope is unclear.

[0158] In some non-limiting examples, procedure 700 can be described with reference to a specific implementation of the laser system. For example, at the start of a lithotomy procedure, the endoscope can be manipulated so that the distal end of the fiber enters or is inserted into a channel in the kidney (or ureter). The distal end of the fiber remains unused, and the response signal of the probing light source detected by a sensor (such as a photodiode) is original and initially related only to the Fresnel reflection of the distal end. Since there is no risk of tissue damage and no stones are present, the calibration procedure can be started at this point. Thus, the physician can start the calibration procedure, for example, by pressing a calibration pedal (button). Once started, the laser emits radiation once or several times at predetermined parameters (pulse output, pulse width, and frequency). Water overheats and bubbles form on the fiber tip side. Simultaneously, the computing device stores the calibration pulse in memory synchronized with three (or more) original baseline (reference) pulse probe light source signals at the moment immediately before the pulse (moment A), during the pulse (moment B), and immediately after the pulse (moment C), as shown in Figure 23. Essentially, these signals are related to Fresnel reflection in the following conditions: A) fluid in the ureter / kidney (mainly water) (less than 0.3% of the probe light source's output power depending on the wavelength), B) "air" with some influence from Fresnel reflection at the boundary between air and water within the formed bubble (the back-reflected portion approaching the surgical fiber) (approximately 3-4% depending on the wavelength of the light source), and C) boundary conditions between case A and case B when the initial bubble is small or has already collapsed. The probe light source may also be a continuous wave source, as shown in Figure 23. Once this calibration procedure is complete, the physician can proceed with treatment.

[0159] While the physician manipulates and guides a fiber (e.g., a surgical fiber) within the renal / ureteral channel, a computing device registers or detects an input response signal initiated by a probe light source returning from the distal end of the fiber. The computing device can compare this response signal to signal A of the calibration procedure. At this point, a more accurate "contact coefficient" parameter can be implemented than an absolute value, which may vary from time to time depending on several circumstances. For example, the contact coefficient parameter can be calculated as K1 = (A1 - A) / A, where A is a reference signal of "water" measured during the calibration procedure, and A1 is the current input signal when there is no laser pulse. If there is no stone / tissue around the fiber tip, A1 = A and K1 = 0. As the fiber tip approaches the target, the back reflection from the target increases the A1 parameter and thus increases K1. Figure 24 is a graph showing the relationship between the contact coefficient between stone and soft tissue and the gap between the fiber tip and the target, using a probe light source wavelength of 1550 nm. Kidney tissue was used as the soft tissue sample.

[0160] The graph in Figure 24 shows that K1 increases from 0 to 0.33 as the laser approaches soft tissue to the point of full contact, and from 0 to 1.39 for stony materials. However, it should be understood that a specific K1 value depends on several application-specific factors, including the laser, optical system, the design of the overall system being implemented, the fiber diameter, and other parameters. Therefore, the K1 value should be evaluated in advance for each laser system design.

[0161] In this example, if the computing device can determine that K1 has increased to 0.33, the tip may be in contact with tissue. If the tissue is not the intended target, the system disables power to the therapeutic laser to avoid causing tissue damage. This allows the doctor to continue searching for stones and adjust the position of the fiber tip. However, if the target is indeed tissue, the system can turn on the laser if K1 > 0.2 (but 0.4 or less) and the gap is approximately 200 microns or less. Only if K1 is greater than 0.4 up to 1.4 or higher, the computing device may determine that it is indeed stone material in front of the fiber tip, and the laser should be turned on when the gap is 0.5 to 0 mm. If K1 is 1.2 or greater and the gap is 100 to 0 microns, the tip is in full contact with the target and the laser can be turned on. This automated mode during lithotripsy prevents the laser from firing into soft tissue if the doctor accidentally touches tissue during stone treatment, as stones are always near or attached to the ureter or kidney. In other non-limiting examples, during calibration mode, if no stone is detected, the laser can fire at lower energy and power, and if a stone is detected, it automatically switches to higher energy and power. This minimizes the backward movement effect and overheating of fluid in the treatment area to prevent damage to soft tissue.

[0162] In some non-limiting examples, other characteristics of the measured signal can be advantageously used to more accurately identify the target and the distance to the target. As an example, Figure 25 is a graph showing the relationship between the derivative of the contact coefficient and the gap between the fiber tip and the target, which may serve as a more sensitive measure of the type of target and the distance to its surface.

[0163] Once it is determined that the therapeutic laser can be effective, the doctor can proceed with treating the stone. In some cases, the doctor may use a pedal to activate the therapeutic laser. A laser pulse with specific parameters (power, width, frequency, etc.) is emitted, and several processes begin. First, if there is any gap between the fiber tip and the target, the laser pulse causes localized overheating, initially vaporizing the water (present in the gap). Bubbles form and begin to grow. The front side of the bubbles reaches the surface of the stone, creating vapor channels, and the "Moses effect" occurs. From this moment on, the laser pulse becomes more "effective" as it affects not only the water but also the stone. Further ablation of the stone surface leads to surface fragmentation and the formation of localized craters, and subsequent crater growth. The small stone particles generated as a product of laser ablation separate from the stone surface and are tracked in all directions, including towards the fiber tip, resulting in rock dust scattering. Backward movement may also occur, causing the stone to move away from the fiber tip. If the pulse frequency is low enough, after one pulse and before the next subsequent pulse, the bubbles begin to collapse, and the gap between the fiber end and the rock fills with water. After the bubbles collapse, there is a rock with a crater located away from the tip of the fiber front. When the next pulse begins, this entire process is repeated from the beginning. While the laser is on and during the treatment of the rock, the response of the probe light source (the probe signal detected by the sensor) changes dramatically due to backscattering from the ablation products. This is due to several factors, one of which is a change in the nature of the amount of backscatter. Another is a change in Fresnel reflection from the fiber tip due to changes in the environment around the tip (e.g., "air" or "water" environment, smooth rock surface or rock surface with craters, distance to the rock, small particle tracking, lack of small particle tracking, absorption of laser light by high-temperature ablation products, dirt at the distal end of the fiber or heated region at the distal tip of the fiber, etc.). Before the pulse, the level of the probing light source response signal must be minimized (Fresnel reflection in water is smaller than in air).During a laser pulse, the level of the probing source response signal can be at its maximum (maximum Fresnel reflection from air and maximum backscattering from porous craters and tracking particles). In the period immediately following the pulse, the probing source response signal should be somewhere between these minimum and maximum levels.

[0164] A computing device can receive all response signals related to the probing light source, analyze these signals, and control the laser system based on this analysis to determine, for example, whether the stone is still within the ablation area or has moved away from another area. If the stone is not within the treatment area, the control system automatically stops the laser operation. To do this, the control system may need to implement additional "contact coefficient" parameters K2 and K3 similar to K1. In some cases, K2 is a parameter related to the moment B during or just before the end of the pulse, where K2 = (B1 - B) / B), and K3 is related to the moment C (immediately after the pulse), where K3 = (C1 - C) / C). For example, B is a reference signal in the "air" (bubble) measured during the calibration procedure, and B1 is the current input signal during or just before the end of the pulse. Furthermore, C is a reference signal, a boundary condition between case A and case B when the initial bubble is small or has already collapsed, measured during the calibration procedure, and C1 is the current input signal immediately after the pulse. These additional contact coefficient parameters can be determined during calibration, and K1, K2, and K3 also need to be evaluated in advance for each laser system design. By calculating the K1, K2, and K3 parameters during the calibration process and using these parameters in combination with real-time results, the probability of detecting stone contact during the laser pulse can be maximized.

[0165] Various kidney and ureteral stones (calcium oxylate monohydrate (COM stones), uric acid, cysteine, etc.) consist of different microstructures, different chemical compositions, (possibly) different typical shapes and sizes, and different amounts of water inside. Therefore, these different types of stones will likely have different backscattered and / or back-reflected probing light source signals, and thus different contact coefficient parameters (K1, K2, and K3) when the distal end of a fiber is in front of some stone.

[0166] Figure 26 is a graph showing the relationship between the contact coefficient K1 for different types of stone and soft tissue, when the fiber tip is in contact with the target (the gap between the fiber tip and the target is 100 microns or less), using a probing light source wavelength of 1550 nm at 15 different points of stone or tissue. For example, the K1 for soft tissue (chicken breast, pig kidney, beef heart) is 0.5 or less. For COM stones, K1 is 0.5 to 0.8, and for uric acid stones, K1 is 0.6 to 1.8. However, it should be understood that K1 can depend on various other parameters, such as the wavelength of the probing light source, fiber diameter, angle of the distal end of the fiber relative to the stone surface, condition of the distal end of the fiber, distance from the distal end of the fiber to the stone surface (as mentioned above), the design of the current laser system, and many other factors. Nevertheless, assuming these parameters are equal, the determined K1 coefficient is relevant to various types of stone, as shown in Figure 26. This can be used in real time to distinguish different types of stone with high probability. If a physician can receive such assistance during surgery using a stone type detector, he or she (and / or the control system) can select the best laser parameters (pulse power, width, frequency, etc.) to fragment the determined type of stone with the greatest possible efficiency. In some cases, these parameters can be determined in advance and pre-set in the smart laser system (e.g., the control system) for the purpose of suggesting or otherwise communicating to the physician the type of stone currently being determined in front of the fiber tip during surgery. This stone type detector can function while the laser is operating. Furthermore, the stone type detector also functions when the stone is not homogeneous and is chemically composed of two or more types of stone, and / or when the fragmentation mode changes in real time depending on the current state (part) of the stone. This capability helps prevent water overheating and reduces the time required to perform the surgical procedure. The control system can also automatically change or modify the laser treatment parameters (laser operating parameters, etc.) according to the stone composition (based on feedback).

[0167] During operation, the fiber tip is prone to burning and degradation, increasing scattering from the fiber tip itself, and ultimately altering the response signal of the probing light source, regardless of the changes caused by backscattering from the stone being treated. This increases the likelihood of making mistakes when sensing contact with the target. In this case, the physician needs to repeat the calibration procedure after a certain period. Another approach is to replace or cut the damaged surgical fiber and perform the calibration procedure.

[0168] Therefore, using a computing device-controlled laser system, response signals corresponding to the probing light source can be received and analyzed in real time before, during, and after laser pulses, for the purpose of distinguishing contact between stone and soft tissue. Furthermore, image data from the scope's imaging sensor can provide information regarding the detection of contact with stone and soft tissue, and the results of image processing can determine the type and condition of the stone and soft tissue. This system can also assist in controlling the laser to enable physicians to make decisions based on more information in areas where the camera's field of view is limited by stone dust, thereby increasing the efficiency of stone treatment, reducing treatment time, and avoiding injury due to improper positioning of the fiber tip during laser pulses.

[0169] Figure 27 shows a flowchart of process 750 for determining the presence of “plasma,” which is visible light flashing within the treatment area. Process 750 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 750 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0170] In some cases, when a laser-treated target begins to emit electromagnetic radiation in the visible wavelength range, this is called “flashing” radiation or “plasma” radiation. The physical origin of this phenomenon varies, ranging from thermal radiation (heat dissipation) to various types of light emission. In practical terms, this phenomenon can affect the image quality of a scope camera and negatively impact the operator's ability to target a desired area of ​​tissue / stone. Figures 28 and 29 show two graphs illustrating the spectral responses (x-axis = wavelength, y-axis = intensity) of water (background) and COM stone, respectively. Specifically, Figure 28 shows the spectrum of the background plasma signal (e.g., the initial light generated) from the interaction of laser light with water, and Figure 29 shows the spectrum of the plasma signal from the interaction between laser light and stone.

[0171] This type of emission may be associated with overheated carbonized tissue or carbonized proteins from rock. Another mechanism could be an overheated distal end of the fiber tip, contaminated with ablation products of tissue or rock attached to the distal end of the fiber. The thermal temperature of this carbonized tissue, rock, or contaminated fiber can reach 1300–2400°C, which can cause damage to the distal end of the fiber. When the temperature of the distal end of the fiber exceeds 800°C, the fiber begins to absorb laser energy and is unable to transmit it. As a result, the efficiency of rock or tissue ablation decreases. The disclosed smart laser system is configured to detect this phenomenon before initiation by performing at least one of the following: a) warning the operator to change the treatment technique, b) pausing the laser treatment to halt the progression of the phenomenon, c) temporarily reducing the laser power and / or pulse energy and / or repetition rate, and / or d) irradiating the fiber, tissue, and / or stone with high peak power or high pulse energy to clean the carbonized tissue or remove ablation products attached to the distal end of the fiber. By using the intensity and spectrum of thermal radiation to determine the fiber tip temperature in real time, the smart laser system can prevent the distal tip temperature from exceeding a predetermined level in the range of 500-800°C, thereby increasing ablation efficiency and preventing fiber tip degradation.

[0172] This detection is implemented by optically monitoring laser-induced emission during or immediately after each laser pulse. Non-limiting examples of the spectral ranges for which the signal is monitored include 300 nm to 1900 nm and 2100 to 2600 nm, preferably the range 400 nm to 900 nm or 400 to 1900 nm. The thermal radiation signal is directed towards the therapeutic fiber and extracted at the proximal end via a dichroic beam splitter or similar device. Thermal radiation has a higher spectrum and intensity than other broad-spectrum radiation such as fluorescence or scope illumination light and can be distinguished by its light intensity level. Back-reflected signals from the probe or laser beam may be selected using a narrow-band-pass filter upstream of the photodetector sensor. The control system (and / or operator) searches for electromagnetic radiation signals (e.g., feedback signals) that have intensity that meets and / or exceeds predetermined criteria. This signal can be distinguished from any other feedback signal because the measurement is received during a specific time window when two conditions are met: (1) the therapeutic laser or laser pulse is on, and (2) all other probe signals are off.

[0173] If the onset of "flashing" is detected, the operator may be warned to change the treatment technique to prevent further progression of the phenomenon. For example, when treating stones, this phenomenon can be prevented (or at least significantly reduced) by using a so-called "dancing" technique, which involves rapidly moving the fiber tip along the surface of the stone being treated. Other technical modifications are also possible.

[0174] In another embodiment, the laser emission can be temporarily paused (in the range of 0.05 to 1 second) at the start of the "flashing," and this can be used to prevent this phenomenon.

[0175] In 752, process 750 may include a computing device that moves the fiber to a therapeutic region containing a therapeutic target, which may be similar to block 602 of process 600. In 754, process 750 may include a computing device that emits laser light from a therapeutic laser toward the therapeutic region (e.g., on the therapeutic target), which may be similar to block 654. In 756, process 756 may include directing a portion of the generated first light to a photodetector. For example, the first light may indicate plasma generation within the therapeutic region, on the fiber, etc. For example, the first light may be generated from the interaction between the laser light and the therapeutic target, the interaction between the laser light and the carbonized material, etc. In some cases, a portion of the first light may be sent back from the distal end of the fiber and out from the proximal end of the fiber to a photodetector. In some cases, a portion of the first light may be filtered before being directed to the photodetector.

[0176] In 758, the process 750 may include a computing device that receives (and filters) data from the photodetector corresponding to a first portion of light that interacts with the photodetector.

[0177] In 760, process 750 may include a computing device that determines whether the data exceeds a threshold. If the computing device determines in 760 that the data exceeds a threshold (e.g., is greater than a certain value) (e.g., the intensity value of the data exceeds a certain threshold), process 750 may proceed to block 762. However, if the computing device determines that the data does not exceed a threshold, process 750 may return to block 754, where the therapeutic laser may continue to emit laser light (or other laser light).

[0178] In 762, process 750 may include the computing device adjusting the operation of the therapeutic laser and notifying the healthcare professional, each of which may be based in particular on data exceeding a threshold. In some cases, the step of adjusting the operation of the therapeutic laser may include adjusting one or more laser operating parameters of the therapeutic laser (e.g., lowering them), pausing the emission of laser light, stopping the emission of laser light, reducing the output of the laser light, or narrowing the pulse width of the laser light. In some cases, it may also include increasing the laser operating parameters (such as the output of the laser light) to clean the distal end of the fiber. In this case, the computing device may, based on the data, determine that the distal end (or other part) of the fiber is contaminated and proceed accordingly to block 760 to adjust the operation of the therapeutic laser, which may include increasing the output of the laser light to clean the laser.

[0179] Figure 30 shows a flowchart of process 800 for determining the temperature of the components of the laser system or the treatment area. Process 800 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 800 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0180] Residual absorption of laser radiation in the liquid medium, combined with heat transfer from the target stone / tissue, can cause the temperature of the corresponding organ (such as the kidneys, ureters, or bladder) to rise. Damage can occur if the temperature in these organs exceeds ~42°C. Therefore, it is important to monitor the temperature rise and prevent excessive temperature increases.

[0181] According to at least one non-limiting example, the laser system herein can be configured with a temperature monitoring function to prevent such overheating. Temperature monitoring can be implemented by detection and interpretation (analysis) of a thermal radiation signal (also referred to herein as thermal radiation) transmitted through the same fiber used in laser treatment. In some non-limiting examples, the wavelength range of the detected signal may be between 1500 nm and 10000 nm, although in some cases this is limited by the transmission characteristics of the fiber used. According to another non-limiting example, the wavelength range is between 300 nm and 2700 nm. When using silica fiber, the upper limit of the wavelength is limited to approximately 2300 nm.

[0182] The thermometer (sensor) can be calibrated in the factory. If the temperature exceeds a predefined standard, the control system can stop emitting the laser and warn the operator.

[0183] In 802, process 800 may include a computing device that moves the fiber to a therapeutic region containing a therapeutic target, which may be similar to block 602 of process 600. In 804, process 800 may include a computing device that emits laser light from a therapeutic laser toward a therapeutic region (e.g., at the therapeutic target), which may be similar to block 654.

[0184] In 806, the process 800 may include a computing device that receives temperature data from a temperature sensor. In some cases, the temperature data may include one or more temperature values. In some cases, the temperature sensor may be in thermal contact with a fiber, a treatment area (e.g., located within the treatment area), etc. In some cases, the temperature data may be derived from data (e.g., from a portion of light from a heating source reflected from a target, including one or more structures in the treatment area, derived from blackbody radiation, etc.).

[0185] In 808, the process may include the computing device determining whether the temperature data exceeds a temperature criterion (e.g., is greater than 10°C). If the computing device determines in 808 that the temperature data exceeds the temperature criterion (e.g., that the temperature value of the temperature data exceeds 10°C), the process 800 may proceed to block 810. However, if the computing device determines in 808 that the temperature data does not exceed the temperature criterion, the process 800 may return to block 804 and continue emitting laser light (or emit different laser light). In some non-limiting examples, the temperature criterion may be substantially 42°C.

[0186] In 810, the process 800 may include a computing device that adjusts the operation of the therapeutic laser based on temperature data exceeding a reference temperature, notifies a medical professional, displays the results, etc., which may be similar to block 760 of the process 750. For example, this may include a computing device that pauses the emission of laser light for a certain period (e.g., a period substantially between 0.05 seconds and substantially 1 second).

[0187] Figure 31 shows a flowchart of process 850 for determining the presence of bubbles in the treatment area. Process 850 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 850 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0188] The first portion of the laser radiation is completely absorbed by the water layer, resulting in the creation of bubbles (vapor channels) between the fiber and the tissue (a phenomenon known as the "Moses effect"). The first portion of the laser radiation needs to be optimized using several criteria, in particular: 1) to minimize the mechanical effects due to the increase in water pressure caused by bubble formation; 2) to minimize the laser energy required to generate the vapor channels; 3) to generate vapor channels of a predefined length; 4) to complete the first portion of the radiation at the moment the vapor channels reach the surface of the target material or tissue; and 5) to complete the first portion of the radiation at the moment a small fragment of stone crosses the vapor channel during popcorn. The energy of the first pulse portion is below or close to the threshold for stone or tissue ablation.

[0189] The second portion of the laser emission begins almost immediately after the first portion is completed (although a short delay may occur in some cases). The laser characteristics of the second portion, such as output, pulse shape, pulse width (pulse length), and energy, are defined for the best tissue treatment effect. In treatments involving stone and tissue ablation, the pulse energy of the second portion of the laser emission must be significantly higher than the ablation threshold. Figure 32 shows a graph illustrating the pulse energy characteristics of the first and second portions of the laser emission for ablation applications. In contrast to ablation, for soft tissue coagulation (hemostasis), the energy of the second portion must be higher than the coagulation threshold but lower than the ablation threshold. Figure 33 shows a graph illustrating the pulse energy characteristics of the first and second portions of the laser emission for coagulation applications.

[0190] In a particular embodiment, the conditions for the first part of the laser emission can be defined as follows: 1. To reduce backward movement during stone processing, minimal mechanical impact from water pressure caused by bubble formation is required. The water pressure during bubble formation is minimized when the power density at the distal end of the fiber is not significantly higher than the water evaporation threshold. According to some non-limiting examples, this ratio is in the range of 1.01 to 10, preferably 1.01 to 2. The optimal pulse width of the first portion of the laser emission, and the corresponding energy / flux at the distal end of the fiber, can be determined based on the maximum expected distance between the stone and the distal end of the fiber. 2. If the bubbles are not spherical but elongated along the axis of the laser beam, the amount of laser energy consumed to create a vapor channel of the desired length can be minimized. This condition can be met by the same criteria outlined in (1) above. 3. To generate a vapor channel of a desired length and with minimal laser energy consumption, a mechanism for growing the vapor channel can be used. In a non-limiting example, this mechanism includes maintaining the ratio between the laser power density at the front of the growing bubble (vapor channel) and the threshold for water evaporation within the range of 1.01 to 10, preferably 1.01 to 2. Beam divergence can be compensated for by increasing the instantaneous power of the pulses in the first portion of the emission. The first portion should terminate when the bubble reaches the desired length. 4. In actual clinical situations, the distance between the distal end of the fiber and the surface of the tissue or stone can be a value that varies widely due to the movement of the fiber. According to one non-limiting example, an adaptive regime is implemented for the first portion of the laser emission. For example, the back reflection of the optical emission of the probing beam is measured before and during the delivery of the first portion of the laser emission when a vapor channel is being created. The backscatter signal changes with the difference between the back reflection coefficient corresponding to the boundary (interface) between vapor and water and this boundary between vapor and tissue. When the detector of the laser system (e.g., in the optical adapter) registers this change, the laser is switched from the first portion of the laser emission to the second portion of the laser emission. In this mode, the minimum energy and output of the first portion of the laser energy are automatically achieved by adjusting these parameters for each laser pulse.

[0191] In the popcorn mode of stone treatment, laser radiation is used to 1) initiate a flow of water to move small fragments of stone (usually less than 3 mm), and 2) ablate (fragment) the small fragments into even smaller fragments. The probability of ablation is very low because it is unlikely that the laser will oscillate at the moment the small fragments get close enough to the distal end of the fiber. According to one non-limiting example, the laser is emitted continuously with low pulse energy and a high repetition rate to generate the flow of water. Also, as the small fragments approach the fiber end, the back reflection coefficient of the probing beam changes, which is detected by the laser system's sensors and control system, and the control system controls the laser so that it immediately emits a high pulse energy to break the small stone fragments into even smaller fragments.

[0192] In 852, process 850 may include a computing device that moves the fiber to a therapeutic region including a therapeutic target, which may be similar to block 602 of process 600. In 854, process 850 may include a computing device that causes a therapeutic laser to emit a first laser beam toward the therapeutic region (e.g., on the therapeutic target), which may be similar to block 654. In some cases, the first laser beam may have first optical properties. For example, the first laser beam may have pulses having a first leading edge, a first falling edge, and a first region between the first leading edge and the first falling edge. In some cases, the first falling edge may be larger than the first leading edge, and the first portion may have a concave shape.

[0193] In 856, process 850 may include a computing device that causes a light source to emit first light toward a treatment area, which may be similar to block 604 of process 600. In 858, process 850 may include directing a portion of the first light toward a photodetector, which may be similar to block 606 of process 600. In 860, process 850 may include a computing device that receives data from a photodetector, corresponding to the interaction between a portion of the first light and the photodetector, which may be similar to block 608 of process 600.

[0194] In 862, process 850 may include a computing device that determines the presence of bubbles (e.g., at the distal end of the fiber) based on data. For example, the first laser beam can form bubbles (e.g., by vaporizing the liquid in the treatment area). Thus, the computing device can compare the data to a criterion (indicating bubbles) and determine the presence of bubbles based on data (e.g., one or more intensity values) that exceeds a desired range or threshold (e.g., the criterion), or determine the absence of bubbles based on data that does not exceed the criterion. In some cases, process 850 may continue to emit the first laser beam until the computing device detects bubbles. In some cases, if the computing device determines that bubbles are present, process 850 may proceed to block 864.

[0195] In block 864, process 850 may include a computing device determining, based on the data, that a vapor channel has reached a therapeutic target (e.g., from the distal end of the fiber). For example, a first laser beam may generate a vapor channel after a bubble is formed (e.g., the vapor channel is guided through the bubble). When the vapor channel reaches the therapeutic target, the reflection of light (e.g., light scattering) may change, which can be used to determine that the vapor channel has reached the therapeutic target. Similar to block 862, block 864 may include a computing device that compares the data to a criterion (indicating a vapor channel formed in contact with the therapeutic target), and based on data (e.g., one or more intensity values) exceeding a desired range or threshold (e.g., the criterion), it can be determined that a vapor channel is present and in contact with the therapeutic target, and based on data that does not exceed the criterion, it can be determined that the vapor channel is not in contact with (or has not formed at all) the therapeutic target. In some cases, process 850 may continue emitting the first laser beam until the computing device detects a channel in contact with the therapeutic target (e.g., the process can return to block 854). In some cases, if the computing device determines that the vapor channel is in contact with the therapeutic target, process 850 may proceed to block 864.

[0196] In some non-limiting examples, after the computing device has determined the presence of a bubble, process 850 may return to block 856 and emit another light (and obtain additional data that can be analyzed according to block 864).

[0197] In 866, the process may include a computing device that causes a therapeutic laser to emit a second laser beam toward a treatment area (e.g., on a therapeutic target), which may be similar to that in block 654. In some cases, the second laser beam may have second optical properties different from the first optical properties of the first laser beam. For example, the output of the second laser beam may be higher than that of the first laser beam, for example, if the second laser beam is configured to excise the therapeutic target. In another example, the output of the second laser beam may be lower than that of the first laser beam, for example, if the second laser beam is configured to coagulate the therapeutic target. In yet another example, the pulse width of the second laser beam may be greater than that of the first laser beam. In these ways, the first laser beam may generate a bubble, create a vapor channel, and expand the vapor channel (within the bubble) until it contacts the therapeutic target, and the second laser beam may pass through the vapor channel and be directed toward the therapeutic target. In this way, the treatment can be more efficient because the laser light does not simply vaporize the liquid undesirably (and is not properly directed to the treatment target).

[0198] Figure 34 shows a flowchart of process 900 for detecting problems related to optical transmission through a fiber. Process 900 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 900 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0199] According to at least one non-limiting example, Figure 35 is an example of a functional schematic diagram of a laser system. A synchronization signal (CLOCK) is generated by a clock generator. A laser source, such as a laser diode, emits a probe pulse each time the leading edge of the clock arrives. The pulse period is longer than the longest flight time of pulses moving from the beginning to the end of the instrument and in the reverse direction. The leading edge duration is less than 0.1 ns, and the pulse duration is several nanoseconds. The short pulse duration and long pulse period ensure a low average power output. If the power is insufficient to reliably detect the reflected signal, the pulse is further amplified.

[0200] Next, the laser radiation is coupled to the fiber optic instrument and partially reflected from the distal end of the fiber or from a crack in the fiber. If the cutting angle at the distal end of the fiber is too large, the reflected output may be too small to be detected. This situation will be explained in more detail below.

[0201] The reflected pulse is received by a sensor such as a photodiode. The signal is then digitized by a comparator, and the comparator's reference level is adjusted. In some cases, the comparator's target level is half the pulse amplitude. Leaving the comparator, the reflected signal is sent to the data input of a D flip-flop. A synchronization signal is delayed by a variable magnitude in steps of less than 0.1 ns within a phase-locked loop and sent to the clock input of the D flip-flop. The results of the comparison between these two inputs are latched at different points in time, thereby fixing the moment of the transition of the comparison result from zero to one, and consequently fixing the leading edge of the reflected pulse.

[0202] Two operating modes are possible. In the first mode, the latch clock delay is scanned stepwise across the entire delay range corresponding to the length of the fiber instrument. Thus, the moment the pulse returns is fixed, and the fiber length is measured. In the second mode, a delay range corresponding to a small area around the tip of the fiber instrument is used. In this example, the reflection of the pulse from the tip is fixed. If the reflected pulse disappears, two variations are possible: a crack inside the fiber or a very large cleavage angle at the tip of the fiber instrument. In either situation, immediate cessation of laser emission is required. Operating the device in the first mode provides detailed information about the fiber instrument, while the second mode is time-efficient.

[0203] In a further embodiment, damage to a surgical fiber can be detected using light transmitted through the fiber. Any light source from the treatment area can be used, such as an LED incorporated into an endoscope. The output of the LED can be measured by the same photodiode used to detect the reflected pulse signal described above. A decrease in the measurement result indicates a problem with the integrity of the fiber. In some cases, the two types of measurements described here can be performed sequentially.

[0204] In summary, fiber breakage and its location can be detected using light from two sources: laser radiation from a laser probe light source and LED light source located in the treatment area. When used in conjunction with the main surgical laser radiation, the reflected probe signal can be spectrally separated and filtered by the system to monitor and react to fiber breakage.

[0205] In 902, process 900 may include a computing device that moves a fiber to a therapeutic region containing a therapeutic target, which may be similar to block 602 of process 600. In 904, process 900 may include a computing device that emits first light from a light source toward the therapeutic region, which may be similar to block 604 of process 600. In 906, process 900 may include directing a portion of the first light to a photodetector, which may be similar to block 606 of process 600. In 908, process 900 may include a computing device that receives data from a photodetector, corresponding to the interaction between a portion of the first light and the photodetector, which may be similar to block 608 of process 600.

[0206] In 910, the process 900 may include the computing device determining the time between the emission of the first light and the reception of data. For example, the computing device may determine a first time when the first light is emitted by the first light source (e.g., create a timestamp), and the computing device may determine a second time when the data is received (e.g., create a timestamp). The computing device may then determine the difference between the first time and the second time.

[0207] In 912, the process 900 may include a computing device that determines a problem with optical transmission through the fiber (for example, based on data). For example, the computing device can compare a time (for example, from block 910) with a desired time, and based on a time shorter than the desired time, the computing device can determine that there is a problem, while if the time is higher than a threshold time, the computing device can determine that there is no problem. If the time between emission and reception is short (for example, shorter than expected), it may indicate that the light is entering the fiber at an undesirable location (for example, far from the distal end).

[0208] In some non-limiting cases, a computing device can determine a problem by comparing data to a baseline; if the data (such as an intensity value) falls below the baseline, the computing device can determine that a problem exists (such as light not being properly transmitted through the fiber). Alternatively, the computing device can determine that no problem exists if the data is above the baseline.

[0209] In 914, process 900 may include a computing device that adjusts the operation of the therapeutic laser and notifies a medical professional, each of which may be based on a problem determined (for example, in block 912). Block 914 may be similar to block 762 of process 750. For example, the computing device may, based on a problem determined in block 914, stop the therapeutic laser from emitting laser light or (temporarily) disable the therapeutic laser from emitting laser light. In some cases, problems may arise from fiber kinks, twists, bends, etc.

[0210] Figure 36 shows a flowchart of process 950 for determining the distance between the distal end of the fiber and the distal end of a medical scope (e.g., the channel of the medical scope that receives the distal end of the fiber). Process 950 can be performed using any of the laser systems described herein (e.g., laser system 100), and process 950 can be performed using one or more computing devices (e.g., computing device 130) as needed.

[0211] Figure 37 shows another example of a laser system where the tip position of the surgical fiber differs from the output of the endoscope. As previously mentioned, the surgical fiber 445 is inserted into the endoscope. The proximal end of fiber 445 is connected to an optical adapter, which is part of the smart laser system, as previously mentioned. The amount of light entering the fiber from the LED light source of the scope 460, due to scattering at the fluid treatment area and organ walls, is measured and analyzed by the laser system's detector and control system. The measurement signal is highly sensitive to the position of the distal end of the fiber relative to the distal end of the endoscope.

[0212] Figure 38 shows a typical dependence of the LED signal measured by the laser system on the position of the distal end of the fiber. In this example, 0 mm corresponds to the position of the distal end of the fiber at the distal end of the endoscope, and is also shown as the "zero" position in Figure 37. This method can be used by the system or user to control the position of the distal end of the fiber relative to the end of the endoscope to be within a predetermined optimal range, e.g., 0-3 mm (e.g., as the correct position of the distal end of the fiber). The system is configured to control the laser source so that high-power laser radiation is not emitted if the distal end of the fiber is in an improper position. This reduces or eliminates the risk of damage to the endoscope shaft when the distal fiber tip is in the working channel of the endoscope and the user activates the therapeutic laser operation using a foot pedal. If the distal end of the fiber is detected in the scope position, the control system blocks the laser operation. If the distal end of the fiber extends more than 3-5 mm from the scope, the fiber may be damaged, and if the fiber is accidentally broken in the scope, the therapeutic laser radiation in the working channel will damage the scope shaft.

[0213] In 952, process 950 may include a computing device that moves a fiber to a therapeutic region containing a therapeutic target, which may be similar to block 602 of process 600. In 904, process 900 may include a computing device that causes a light source located within the processing region to emit first light toward the processing region. Block 904 may be similar to other blocks of other processes described herein. In 956, process 950 may include directing a portion of the first light toward a photodetector, which may be similar to block 606 of process 600. In 958, process 900 may include a computing device that receives data from a photodetector, corresponding to the interaction between a portion of the first light and the photodetector, which may be similar to block 608 of process 600.

[0214] In 960, the process 950 may include a computing device that determines the distance between the distal end of a medical scope and the distal end of a fiber based on the data. For example, the computing device may compare the data to a curve (e.g., the curve in Figure 38) relating to the intensity values ​​of light (e.g., first light) relative to the position of the distal end of the fiber relative to the distal end of the medical scope in order to determine the distance.

[0215] In block 962, process 950 may include a computing device that determines whether the distance (determined in block 960) exceeds a distance criterion. If, in block 962, the computing device determines that the distance exceeds the distance criterion (e.g., greater than or possibly less than), process 950 can proceed to block 964. However, if, in block 962, the computing device determines that the distance does not exceed the distance criterion, the process can return to block 954 (or block 952). In some cases, it is undesirable to fire a therapeutic laser if its distal end is inside a medical scope (e.g., it may damage internal components of the medical scope). Also, if the distal end of the therapeutic laser is too far from the distal end of the scope, the laser light may not be delivered correctly. In some cases, the distance criterion may be substantially -1 mm, 0 mm, 1 mm, 3 mm, etc.

[0216] In 964, process 950 may include a computing device that adjusts the operation of the therapeutic laser and notifies healthcare professionals, each of which may be based on a distance exceeding a criterion determined (for example, in block 962). Block 962 may be similar to block 762 of process 750. For example, the computing device may stop or (temporarily) disable the emission of laser light from the therapeutic laser based on a distance exceeding a criterion.

[0217] Thus, a variety of systems and methods have been offered. In some non-limiting examples, stones (e.g., kidney stones, ureteral stones, etc.) and soft tissues have different structures (and material properties) that produce specific responses to probe light (e.g., light from one of the light sources). For example, different stones may have different chemical compositions, and generally, stones are mostly minerals with water present in the intercrystalline and microcrystalline spaces (e.g., about 10% of the total volume of the stone). Furthermore, stones may have small organic molecules attached to them, and each stone may have a different microstructure, macrostructure, shape, surface structure, and state. Each of these can define the optical properties of the stone, including absorption spectra, scattering coefficient spectra, and the angular distribution of scattered light. In some cases, stones backscatter probe light, resulting in various types of scattering (Rayleigh, Mie, etc.). In contrast to stones, tissues (kidney, ureter, soft tissue, etc.) may contain organic extracellular matrix, vascular systems, and cells. Aside from the substantial difference in water content between tissue and stone (e.g., tissue contains substantially 70-80% water, while stone may contain substantially 10%), tissue can have a non-porous structure and a smooth surface (compared to stone). As a result, tissue has different optical properties than stone. For example, tissue can scatter less light than stone (e.g., under most conditions), especially in wavelength ranges where absorption by water and blood is significant (e.g., light is absorbed by tissue and therefore not scattered). Thus, the light returned to the distal end of the fiber can be used to determine (e.g., by a computing device) whether the therapeutic target (or other structure near the fiber) is stone or tissue. Furthermore, the light returned to the distal end of the fiber can even identify the type of stone, for example, if the therapeutic target is determined to be stone.

[0218] In some non-limiting examples, as the probe light approaches the treatment target (or other structure near the fiber), the amount of light returned to the distal end of the fiber increases (e.g., the probing light is reflected from the target and directed towards the distal end of the fiber). For example, if the distal end of fiber 108 is in contact with the treatment target (in some cases, the gap is about 100 microns or less), the amount of light returned to the distal end of the fiber (e.g., originating from the light source emitting the probe light) is maximized, as at least more light is returned to the fiber rather than dissipated within the treatment area. However, this response may differ between stone and soft tissue, particularly because the amount of backscattered light from stone and soft tissue differs, as absorption by blood and / or water occurs in the wavelength range (e.g., tissue absorbs more of this light than stone, and stone generates a larger amount of backreflected light at these wavelengths). The probing light (which may be a laser beam, for example) may have several wavelengths that maximize the contrast between the backreflected signals from stone and tissue (soft tissue, for example). In some non-limiting examples, the probing light may be a broad-range continuous-spectrum source such as an LED or lamp (e.g., probing light having one or more wavelengths in the range substantially from 400 nm to substantially 750 nm) for the purpose of obtaining a wide range of spectral back-reflected signals from the tissue or stone.

[0219] In some non-limiting examples, a computing device can detect contact between a fiber and a therapeutic target (e.g., a stone vs. tissue) by establishing or determining a specific threshold, desired range, or limit above or below the light returned to the distal end of the fiber (e.g., the intensity of the light returned to the distal end of the fiber from the emitted probing light) corresponding to contact (or quasi-contact) with the therapeutic target. For example, a computing device can receive data from a detector (e.g., one of the photodetectors) that detects backscattered light (e.g., light returned to the distal end of the fiber), and based on the data (e.g., analysis of the data), it can determine the distance between the distal end of the fiber and the therapeutic target, which includes determining whether the fiber is in contact with the therapeutic target. This process can be implemented in real time (e.g., in relation to a healthcare professional) to provide (and display on a screen) the current distance between the distal end of the fiber and the therapeutic target so that the laser system (or healthcare professional) can adjust the control of the therapeutic laser accordingly. In some non-limiting examples, the process of detecting backscattered light from the distal end of the fiber (if present) and comparing it to a limit or range (e.g., one or more reference values ​​based on data from urine, water, air, etc., when no therapeutic target is present, or based on data from surgical components such as catheters, baskets, stents, or sheaths) may allow the laser system to determine approach to a target, detect contact with the target, and distinguish whether the target is a stone (of a certain kind), tissue, or surgical component.

[0220] In some non-limiting cases, if the fiber is in contact with the treatment target or surgical component, or within a predetermined distance (e.g., 1 mm), the medical professional (or computing device) may turn on the therapeutic laser or increase the laser power / energy of the laser therapeutic light to treat the treatment target. In some cases, if the fiber is in contact with or close to a surgical component, the medical professional (or computing device) may turn off the therapeutic laser or reduce the power of the laser therapeutic light to prevent laser damage to the surgical component. In some configurations, if the distance is greater than a desired range or limit, or if the treatment target is determined to be a target material, but part of the object is determined to be tissue, and the treatment is not intended to excise or coagulate soft tissue, the laser system (e.g., computing device) may notify the medical professional to prevent the emission of laser therapeutic light. In some cases, the laser system (e.g., computing device) may turn on the therapeutic laser, turn off the therapeutic laser, change the power of the laser therapeutic light, change the energy of the laser therapeutic light, etc., based on data of the light returned to the distal end of the fiber (e.g., backscattered light).

[0221] In some non-limiting examples, if a bubble (e.g., air bubble) forms in front of a fiber within the treatment area, the laser system can detect or determine whether the reflected light (e.g., light returned to the distal end of the fiber) is from the interface (or, in other words, boundary) between air and water in front of the (growing) bubble (e.g., if there is no tissue or stone inside the bubble). Furthermore, the laser system can determine if the reflected light is within the volume of the bubble (e.g., between air and tissue or stone, including if tissue or stone is inside the bubble). In some cases, the probe light may be the laser treatment light (e.g., light returned to the distal end of the fiber), while in other cases, the probing light may be from another light source (e.g., one of the light sources). In some cases, the probing light may have a wavelength specifically selected for high resolution in the two scenarios described above (e.g., reflected light from outside and inside the bubble).

[0222] In some non-limiting cases, laser systems may be configured to detect damage (or the inability to properly emit laser light) using the principle of laser reflectivity measurement. For example, a laser (e.g., a therapeutic laser, or one of other light sources) can emit short probe pulses of light into a fiber, which are reflected from the distal end of the fiber or by cracks inside the fiber. A detector (e.g., one of the photodetectors, such as a photodiode) can receive the reflected light pulses, and a computing device can determine the delay relative to the initial pulse. This delay is clearly related to the distance from the laser to the point of reflection, and the system can be used to detect damage to the fiber (or the condition of the fiber that prevents it from properly emitting laser light from its distal end), as will be explained in more detail below. In some cases, detecting damage to a fiber may also be based simply on sensing the optical signal transmitted through the surgical fiber. In this case, any illumination source in the treatment area (e.g., an LED or lamp incorporated into an endoscope) can generate light, and a detector, such as a photodetector in a laser system, can sense the transmission (or lack thereof) of light through the fiber.

[0223] In some non-limiting examples, the laser system (and others described herein) can be calibrated to a specific desired range or level of analyzed data, or a combination of data (e.g., data from multiple detectors). This allows for interruption of the therapeutic laser operation, alerting the medical professional (e.g., audio via a speaker, visual signals displayed on a screen), and suggestion of further action. In some non-limiting examples, either scenario may require user input regarding whether to continue treatment (e.g., continue delivering the laser therapeutic light), adjust operating conditions (e.g., adjust therapeutic laser operating parameters, move fiber 108, temporarily suspend delivery of the laser therapeutic light), or ignore the system's recommendations.

[0224] In some non-limiting cases, laser systems can be calibrated in a specific clinical environment before treatment, or even configured to self-calibrate during clinical procedures. Laser systems can also be configured to accumulate feedback signals (e.g., data from light returned to the distal end of the fiber) based on the user's specific characteristics and reactions, analyzing and classifying patterns to enhance the potential for "smarter" responses and recommendations. In some cases, laser systems can function semi-autonomously, autonomously, and so on.

[0225] In some non-limiting examples, the laser therapy light from the therapeutic laser, the light from each light source, and the light received by each photodetector can be implemented in different ways. For example, the laser system may include one or more optical fiber couplers to facilitate the light from each light source reaching the fiber, the laser therapy light from the therapeutic laser reaching the fiber, and the light from fiber 108 reaching each photodetector. For example, the laser system may include an N×1 tree coupler (i.e., a first tree coupler) having N inputs and 1 output, where each of the N inputs can communicate optically with its respective light source, and the first output can communicate optically with the fiber (e.g., coupled to the proximal end of the fiber). Correspondingly, the laser system may include a 1×N tree coupler (i.e., a second tree coupler), where one input can communicate optically with the fiber (e.g., coupled to the proximal end of the fiber), and each of the N outputs can communicate optically with its respective photodetector. In some cases, a 3x1 tree coupler (i.e., a third tree coupler) can be included in the laser system, with the first of the three inputs coupled to the output of the first tree coupler, the second of the three inputs coupled to the input of the second tree coupler, and the third of the three inputs coupled to the laser fiber (for example, the laser therapeutic light directed towards). The output of the third tree coupler can then be coupled to the proximal end of the fiber. In this way, each light source, each photodetector, and the therapeutic laser can communicate optically with their respective fibers and each can be coupled to the fiber. Thus, each fiber can define a different optical path for each light source, the light emitted by the therapeutic laser, and the light received by each photodetector. This is just one example, and other examples can be considered for routing various optical channels into (and from) the fiber. For example, a multicore optical cable can communicate optically with the fiber, and each channel of the multicore optical cable communicates optically with its respective photodetector. Similarly, a multicore optical cable can communicate optically with fiber, and each channel of the multicore optical cable communicates optically with its respective light source.

[0226] While this disclosure has described one or more preferred non-limiting examples, it should be understood that many equivalents, substitutes, variations, and modifications are possible and fall within the scope of this disclosure, apart from those expressly stated.

[0227] This disclosure should be understood to be limited in its application to the structural details and component arrangements shown in the following description or in the following drawings. Other non-limiting examples are possible and can be practiced or implemented in a variety of ways. Also, it should be understood that the expressions and terminology used herein are for illustrative purposes only and should not be considered limiting. The use of “includes,” “equips,” or “has” and their variations herein means to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise specified or limited, the terms “attached,” “connected,” “supported,” and “coupled,” and their variations, are used broadly and include both direct and indirect attachments, connections, supports, and couplings. Furthermore, “connected” and “coupled” are not limited to physical or mechanical connections or couplings.

[0228] As used herein, unless otherwise limited or defined, discussions of particular orientations are provided only as examples with respect to specific, non-limiting examples or related figures. For example, discussions of “top,” “front,” or “back” features are generally intended to describe only the orientation of such features relative to the reference frame of a particular example or figure. Correspondingly, for example, in some configurations or non-limiting examples, a “top” feature may be positioned below (or similarly) a “bottom” feature. Furthermore, references to particular rotations or other movements (e.g., counterclockwise rotations) are generally intended to describe only the movement relative to the reference frame of the figure in a particular example.

[0229] In some non-limiting examples, aspects of the Disclosure, including computerized implementations of the methods described herein, can be implemented as systems, methods, apparatus, or products to control processor devices (e.g., serial or parallel general-purpose or dedicated processor chips, single or multicore chips, microprocessors, field-programmable gate arrays, control units, arithmetic logic units, and various combinations of processor registers, etc.), computers (e.g., processor devices operably coupled to memory), or other electronically operated controllers implementing aspects detailed herein. Thus, for example, some non-limiting examples of the Disclosure can be implemented as a set of instructions specifically embodied on a non-temporary computer-readable medium so that a processor device can implement the instructions based on reading the instructions from the computer-readable medium. Some non-limiting examples of the Disclosure may include (or utilize) control devices such as automation devices, dedicated or general-purpose computers, and various computer hardware, software, firmware, etc., which are consistent with the following discussion. As a concrete example, a control device may include a processor, microcontroller, field-programmable gate array, programmable logic controller, logic gates, and other typical components known in the art to implement the appropriate functions (e.g., memory, communication systems, power supply, user interface, and other inputs).

[0230] As used herein, the term “product” is intended to encompass computer programs accessible from any computer-readable device, carrier (e.g., non-transient signals), or medium (e.g., non-transient media). For example, computer-readable media include, but are not limited to, magnetic storage devices (e.g., hard disks, floppy disks, magnetic strips, etc.), optical discs (e.g., compact disks (CDs), digital versatile disks (DVDs), etc.), smart cards, and flash memory devices (cards, sticks, etc.). Furthermore, it should be understood that carrier waves can be used to carry computer-readable electronic data, such as for sending and receiving emails or accessing networks such as the Internet or local area networks (LANs). Those skilled in the art will recognize that many modifications can be made to these configurations without departing from the scope or spirit of the claimed subject matter.

[0231] The methods described herein, or the specific operation of systems that perform such methods, can be schematically shown in the figures or discussed herein. Unless otherwise specified or limited, a graphical representation of a particular operation in a particular spatial order may not necessarily require that those operations be performed in a particular order corresponding to that spatial order. Accordingly, certain operations shown in the figures or disclosed herein may be performed in an order different from that expressly illustrated or described, as appropriate for certain non-limiting examples of this disclosure. Furthermore, in some non-limiting examples, certain operations may be performed in parallel, including by dedicated parallel processing devices or separate computing devices configured to interoperate as part of a larger system.

[0232] As used herein in the context of computer implementations, unless otherwise specified or limited, terms such as “component,” “system,” and “module” are intended to encompass some or all of a computer-related system, including hardware, software, a combination of hardware and software, or software in which it is running. For example, a component may be, but is not limited to, a processor device, a process (or executable) performed by a processor device, an object, an executable file, an execution thread, a computer program, or a computer. As an example, both an application running on a computer and the computer itself can be components. One or more components (or systems, modules, etc.) may reside within an execution process or thread, may be localized on one computer, may be distributed across two or more computers or other processor devices, or may be contained within another component (or system, module, etc.).

[0233] In some implementations, the devices or systems disclosed herein may be used or installed using methods that embody aspects of this disclosure. Accordingly, any description herein of specific features, functions, or intended purposes of a device or system is generally intended to essentially include disclosures of how to use such features for the intended purposes, how to implement such functions, and how to install components disclosed (or known) to support these purposes or functions. Similarly, unless otherwise indicated or limited, any discussion herein of any method of manufacturing or using a particular device or system, including installation of the device or system, is essentially intended to include, as a non-limiting example of disclosure, disclosures of the utilized features and implemented capabilities of such device or system.

[0234] As used herein, unless otherwise defined or limited, ordinal numbers are used herein for convenience of reference, generally based on the order in which certain components are presented with respect to the relevant parts of the disclosure. In this regard, designations such as “First,” “Second,” etc., generally indicate only the order in which the relevant components are introduced for discussion, and generally do not indicate or require any particular spatial arrangement, functional or structural superiority or order.

[0235] As used herein, unless otherwise defined or limited, terms indicating direction are used for the convenience of reference for the discussion of a particular figure or example. For example, references to a downward (or other) direction or an upward (or other) position may be used to describe a particular example or figure, but not all installations or configurations necessarily require the same orientation or shape.

[0236] This discussion is presented to enable those skilled in the art to create and use non-limiting examples of the disclosure. Various modifications to the illustrated examples will be readily apparent to those skilled in the art, and the general principles of this specification can be applied to other examples and uses without departing from the principles disclosed herein. Thus, the non-limiting examples of this disclosure are not intended to be limited to the non-limiting examples shown, but should be given the broadest scope that coincides with the principles and features disclosed herein and the following claims. The following detailed description should be read with reference to the figures, and similar elements in different figures have the same reference number. Figures that are not necessarily to scale are selected examples and are not intended to limit the scope of the disclosure. Those skilled in the art will recognize that there are many useful alternatives to the examples provided herein that fall within the scope of the disclosure.

[0237] The aspects disclosed herein in accordance with this disclosure are not limited in their application to the structural details and component arrangements shown in the following description or in the accompanying drawings. These aspects can be envisioned in other non-limiting examples and can be practiced or implemented in a variety of ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to limit them. In particular, actions, components, elements, and features described in relation to any one or more non-limiting examples are not intended to be excluded from similar roles in any other non-limiting examples.

[0238] Furthermore, the terms and technical terms used herein are for illustrative purposes only and should not be considered limiting. Any singular reference to an example, non-limiting example, component, element, or action of any system or method referred to herein may also include non-limiting examples containing the plural, and any plural reference to an non-limiting example, component, element, or action herein may also include non-limiting examples containing only the singular. Singular or plural references are not intended to limit the systems or methods, their components, actions, or elements currently disclosed. The use of “includes,” “equips,” “has,” “contains,” “involves,” and their variations herein means that the items listed thereafter and their equivalents, as well as additional items, are included. References to “or” may be interpreted as comprehensive, so that the term described using “or” may refer to one, plural, or all of the terms described. Furthermore, if there is any inconsistency in the use of terminology between this document and any document incorporated herein by reference, the use of terminology in the incorporated reference is supplementary to the terminology in this document, and the terminology in this document shall prevail in the event of any irreconcilable inconsistencies. Additionally, titles or subtitles may be used herein for the convenience of the reader, but these shall not affect the scope of this disclosure.

[0239] Having thus described several aspects of at least one example, it should be understood that various changes, modifications, and improvements are readily conceivable to those skilled in the art. For example, the examples disclosed herein can also be used in other contexts. Such changes, modifications, and improvements are intended to be part of this disclosure and within the scope of the examples discussed herein. Thus, the foregoing description and drawings are merely examples.

[0240] As used herein, “relevant quantities”—scalar or vector quantities—are obtained from collected data by applying at least one of the following operations: weighted integration, weighted differentiation, averaging, normalization to reference data, addition, subtraction, multiplication, or division. The specific set and order of operations are selected based on the final analytical objective (e.g., identification of target and non-target tissues). The obtained quantities are generally compared to a multidimensional set of thresholds to achieve the desired analytical objective.

[0241] As used herein, “data” or “optical data”—any sequence or combination of signals obtained from a photodetector in a system—includes, but is not limited to, raw signal values, time profiles of the signals, spectral signatures of the signals, maximum / minimum values ​​of the signals, correlation functions of the signals, average values ​​of the signals over a period of time, and standard deviations of the signals.

[0242] As used herein, the target material and the stone can be used interchangeably. For example, the target material may be a stone, and the stone may be the target material.

[0243] While most of the non-limiting examples disclosed herein deal with laser lithotripsy of urinary stones, other applications addressing other conditions, such as bladder and other body stones, tissue incision, vaporization, and coagulation, other body regions, and forms of directed energy, are also within the scope of this disclosure.

[0244] Various features and advantages of this disclosure are described in the following claims. [Explanation of symbols]

[0245] 100 Smart Laser Systems 101 Laser Driver 102 Surgical treatment environment 105 Multifunctional Optical Adapter 110 Laser Source 120 sensors 130 Source 140 Free Beam 145, 159 Surgical optical fibers 150, 450 control systems 151 Control Center 152 Therapeutic Lasers 155, 167 Scope Ports 162, 164, 166, 168, 170, 174, 178, and 180 166 Imaging systems, image processors, endoscopes 168 Shaft 169 Lamp 170 Suction / Irrigation Subsystem 171 Video Control 189 Bonded Lens 192, 392, 445 Fibers 214, 216, 218, 220, 385a, 385b Beam Splitter 222, 224 lenses 226, 228 direction 260 Output device 262 Input device 300, 303, 500 Laser Systems 305 Optical Adapter 310, 410 laser sources 318 Multicore Fiber 330 light source 345, 545 Surgical Fiber 381 Reverse Fiber Combiner 383 Quartz Block 384 Collimating Lens 386 Aiming Light Source 387 Focusing lens 388 Protective window 389 Coupling Lens 390 filters 391 Fiber Connector 394, 448 spectrometer 396 Cable 437 Excitation source 445 Fiber Optic Equipment 446, 447 detectors 530 Target 552 organs 560 Endoscopes 564 Lighting source 562 Video camera (image sensor) Processing 600, 650, 700, 750, 800, 850, 900, 950 Blocks 602, 604, 606, 608, 610, 612, 614, 616, 654, 660, 662, 666, 704, 708, 718, 720, 722, 724, 726, 754, 760, 762, 804, 854, 856, 862, 864, 910, 912, 914, 952, 954, 960, 962, 964 1701, 1702 time interval 1717 Backward reflection light

Claims

[Claim 1] A surgical fiber optically coupled to a light source, A photodetector configured to receive the portion of light from the light source that is reflected from the treatment area, and configured to generate optical data corresponding to the portion of the reflected light detected by the photodetector, A computing device configured to analyze the optical data against a characteristic standard and to control the operation of a laser source based on a comparison of the optical data with the characteristic standard, A surgical laser system equipped with [features / equipment].

Images