Surgical laser system with controlled retropulsion setting

Abstract

Laser lithotripsy systems and methods with a controlled retropulsion setting to facilitate manipulation, migration, and ablation of a calculi structure are disclosed. An endoscopic lithotripsy system comprises a laser system to provide laser pulses to a calculi structure in an anatomical environment, and a controller circuit to localize the calculi structure. If it is determined that the calculi structure is not at a target location, the laser system emits first laser pulses according to a first laser output setting, which produces a high retropulsion effect to mobilize and reposition the calculi structure to the target location. For calculi structure located at or migrating to the target location, the laser system emits second laser pulses according to a second laser output setting, which produces a lower retropulsion effect than the first laser pulses, but a higher efficiency to ablate or fragment the calculi structure.

Description

Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 SURGICAL LASER SYSTEM WITH CONTROLLED RETROPULSION SETTING PRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No.63 / 617,922, filed on January 5, 2024, the contents of which are incorporated herein by reference. TECHNICAL FIELD

[0002] This document relates generally to surgical laser systems, and more specifically relates to an endoscopic laser lithotripsy system with a controlled retropulsion setting to facilitate manipulation, migration, and ablation of a calculi structure. BACKGROUND

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

[0004] Laser or plasma systems have been used for delivering surgical laser energy to various target treatment areas such as soft or hard tissue. Examples of the laser treatment include ablation, coagulation, vaporization, fragmentation, etc. In lithotripsy applications, laser has been used to break down calculi structures in kidney, gallbladder, ureter, among other stone-forming regions, or to ablate large calculi into smaller fragments. The calculi fragments may be removed via a working channel of an endoscope (e.g., an ureteroscope) or may be passed naturally by the patient following the procedure.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 SUMMARY

[0005] During endoscopic laser lithotripsy, retropulsion of a calculi structure may lead to calculi migration into other anatomical structures. Retropulsion may be generated by the pressure wave created by stone fragments released from the laser impact on the calculi structure and thermal-induced vapor bubbles and resulting fluid turbulence exerted on the calculi structure. Stone retropulsion and migration may require additional procedures and constant repositioning of laser fiber tip for treating and removing residual calculi. This may reduce ablation efficiency, decrease a stone-free rate, and increase operative time and chances of infection and other complications.

[0006] Holmium:Yttrium-Aluminium-Garnet (Ho:YAG) laser lithotripsy has become the standard for treating urinary stones due to its safe, efficient and versatile properties. Ho:YAG laser, however, generally has a high stone retropulsion effect on the stone target. Thulium laser has been identified as an alternative laser source in lithotripsy procedures due to its lower retropulsion effect and greater ablation and fragmentation efficiency than Ho:YAG laser. Although low retropulsion effect is desired due to its high ablation efficiency, in certain occasions particularly when renal stones are located at certain “inconvenient” locations where stones can move around and migrate to other parts of the renal system, lasers may be inadvertently fired at unintended region such as healthy tissue surrounding the calculi target. On the other hand, due to the complexity of the shape and structure of renal stones, they are not always ideally placed for ablation. Stone locations and postures may make it difficult to stabilize the endoscopic laser device to provide precise treatment. Large fragments resulted from stone breaking have to be chased and searched for in new areas as the stone fragments scatter upon breaking, or is close to a sensitive structure. The present inventors have recognized that in these situations, high retropulsion laser setting, even may not be ideal for highly efficient ablation, may nevertheless be utilized to mobilize and manipulate the renal stones in a controlled manner, such that the renal stones may be chased by controlled retropulsion force and migrate to a more convenient location, such as major or minor calyx of kidney, which serves as a “dead end” or a tight space that canClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 securely stabilize the stones or a stone fragments. The controlled stone migration and stabilization in convenient renal locations, effectuated by high retropulsion laser setting, may improve ablation efficiency and patient safety. It also makes it easier to collect stone fragments from those convenient renal locations.

[0007] The present document describes endoscopic laser lithotripsy systems and methods with a controlled retropulsion setting during a lithotripsy procedure. An exemplary surgical laser system comprises a laser system to provide laser pulses to a calculi structure in an anatomical environment, and a controller circuit to localize the calculi structure. If it is determined that the calculi structure is not at a target convenient location, the laser system can emit first laser pulses according to a first laser output setting, which produces a high retropulsion effect to mobilize and chase the calculi structure to the target convenient location in a controlled manner. For calculi structure located at or pushed by retropulsion force to the target convenient location, the laser system can emit second laser pulses according to a second laser output setting, which produces a lower retropulsion effect than the first laser pulses but a higher efficiency to ablate or fragment the calculi structure.

[0008] Example 1 is an surgical laser system. The system includes: a laser system configured to provide laser pulses to a calculi structure in an anatomical environment of a patient via a laser fiber according to an adjustable laser output setting; and a controller circuit configured to: localize the calculi structure in the anatomical environment; if the calculi structure is at a location other than a target location, generate a control signal to the laser system to emit first laser pulses according to a first laser output setting, the first laser pulses having a first retropulsion effect to mobilize and reposition the calculi structure to the target location; and generate a control signal to the laser system to emit second laser pulses according to a second laser output setting to ablate or fragment the calculi structure at the target location, the second laser pulses having a second retropulsion effect lower than the first retropulsion effect.

[0009] In Example 2, the subject matter of Example 1 optionally includes, wherein the calculi structure includes a renal calculi structure, wherein the target location includes a major or minor calyx of a kidney.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0010] In Example 3, the subject matter of any one or more of Examples 1–2 optionally include an imaging sensor configure to provide an image or video stream of the calculi structure in the anatomical environment, wherein the controller circuit configured to localize the calculi structure using the image or video stream of the calculi structure.

[0011] In Example 4, the subject matter of any one or more of Examples 1–3 optionally includes the laser system that can include: a Holmium:Yttrium- Aluminium-Garnet (Ho:YAG) laser source configured to emit the first laser pulses having the first retropulsion effect; and a thulium laser source configured to emit the second laser pulses having the second retropulsion effect.

[0012] In Example 5, the subject matter of any one or more of Examples 1–4 optionally includes the laser system that can include a thulium laser source configured to generate thulium laser pulses in accordance with an adjustable laser output setting, including first thulium laser pulses having the first retropulsion effect and second laser thulium pulses having the second retropulsion effect.

[0013] In Example 6, the subject matter of Example 5 optionally includes the first laser output setting that can include a rectangular laser pulse waveform with a specific pulse amplitude.

[0014] In Example 7, the subject matter of any one or more of Examples 5–6 optionally includes the first laser output setting that can include a descending triangle laser pulse waveform with a specific descending rate or pulse duration.

[0015] In Example 8, the subject matter of any one or more of Examples 1–7 optionally includes the first laser pulses that can include a train of laser pulses with an adjustable pulse amplitude or an adjustable pulse width.

[0016] In Example 9, the subject matter of Example 8 optionally includes the controller circuit that can be configured to adjust one or more of a pulse amplitude or a pulse width such that the train of laser pulses incident on the calculi structure produces vapor bubbles at a vicinity of the calculi structure that mobilize and cause migration of the calculi structure.

[0017] In Example 10, the subject matter of Example 9 optionally includes the controller circuit that can be configured to, in a presence of theClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 vapor bubbles, temporarily withhold emission or adjust one or more of the pulse amplitude or the pulse width of the first laser pulses to facilitate collapse of the vapor bubbles at a distance away from the calculi structure, , the collapse of the vapor bubbles producing a propulsion force against a surface of the calculi structure.

[0018] In Example 11, the subject matter of any one or more of Examples 1–10 optionally includes the controller circuit that can be configured to generate a control signal to an actuator to robotically adjust at least a distal portion of the laser fiber.

[0019] In Example 12, the subject matter of Example 11 optionally includes, wherein to robotically adjust at least the distal portion of the laser fiber includes to withdraw the distal portion of the laser fiber away from the calculi structure to create a space in between that facilitates formation of vapor bubbles in response to the first laser pulses incident on the calculi structure according to the first laser output setting.

[0020] Example 13 is a method of operating a surgical laser system to ablate or fragment a calculi structure in an anatomical environment of a patient via a laser system. The method includes steps of: endoscopically placing a laser fiber to the calculi structure in the anatomical environment; localizing the calculi structure in the anatomical environment; when the calculi structure is at a location other than a target location, controllably adjusting the laser system to emit first laser pulses according to a first laser output setting, the first laser pulses having a first retropulsion effect to mobilize and reposition the calculi structure to the target location; and when the calculi structure is located at the target location, controllably adjusting the laser system to emit second laser pulses according to a second laser output setting to ablate or fragment the calculi structure at the target location, the second laser pulses having a second retropulsion effect lower than the first retropulsion effect.

[0021] In Example 14, the subject matter of Example 13 optionally includes the calculi structure that can include a renal calculi structure, wherein the target location includes a major or minor calyx of a kidney.

[0022] In Example 15, the subject matter of any one or more of Examples 13–14 optionally includes generating an image or video stream of theClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 calculi structure in the anatomical environment using an imaging sensor, wherein localizing the calculi structure includes using the image or video stream of the calculi structure.

[0023] In Example 16, the subject matter of any one or more of Examples 13–15 optionally includes controllably adjusting the laser system to emit first laser pulses that can include activating a Holmium:Yttrium- Aluminium-Garnet (Ho:YAG) laser source to emit the first laser pulses having the first retropulsion effect, wherein controllably adjusting the laser system to emit second laser pulses incudes activating a thulium laser source to emit the second laser pulses having the second retropulsion effect lower than the first retropulsion effect.

[0024] In Example 17, the subject matter of any one or more of Examples 13–16 optionally includes controllably adjusting the laser system to emit first laser pulses that can include activating a thulium laser source to emit first thulium laser pulses having the first retropulsion effect, wherein controllably adjusting the laser system to emit second laser pulses incudes activating the thulium laser source to emit second laser thulium pulses having the second retropulsion effect lower than the first retropulsion effect.

[0025] In Example 18, the subject matter of any one or more of Examples 13–17 optionally includes the first laser output setting that can include a rectangular laser pulse waveform with a specific pulse amplitude.

[0026] In Example 19, the subject matter of any one or more of Examples 13–18 optionally includes the first laser output setting that can include a descending triangle laser pulse waveform with a specific descending rate or pulse duration.

[0027] In Example 20, the subject matter of any one or more of Examples 13–19 optionally includes the first laser pulses that can include a train of laser pulses with an adjustable pulse amplitude or an adjustable pulse width, the method further comprising adjusting one or more of a pulse amplitude or a pulse width such that the train of laser pulses incident on the calculi structure produces vapor bubbles at a vicinity of the calculi structure that mobilize and cause migration of the calculi structure.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0028] In Example 21, the subject matter of Example 20 optionally includes, in a presence of the vapor bubbles, temporarily withholding emission or adjusting one or more of the pulse amplitude or the pulse width of the first laser pulses to facilitate collapse of the vapor bubbles at a distance away from the calculi structure, the collapse of the vapor bubbles producing a propulsion force against a surface of the calculi structure.

[0029] In Example 22, the subject matter of any one or more of Examples 13–21 optionally includes generating a control signal to an actuator to robotically withdraw at least a distal portion of the laser fiber away from the calculi structure to create a space in between that facilitates formation of vapor bubbles in response to the first laser pulses incident on the calculi structure according to the first laser output setting.

[0030] This summary is an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Various embodiments are illustrated by way of example in the figures of the accompanying drawings. Such embodiments are demonstrative and not intended to be exhaustive or exclusive embodiments of the present subject matter.

[0032] FIG.1 is a block diagram illustrating an example of a laser energy delivery system configured to provide laser treatment to a target structure in a body, such as an anatomical structure or a calculi structure.

[0033] FIG.2 is a block diagram of an example surgical laser system with a controlled retropulsion setting, and at least a portion of the environment in which the system may operate.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0034] FIG.3 illustrates an example of an endoscopic laser lithotripsy system with a controlled retropulsion setting.

[0035] FIG.4 illustrate by way of example and not limitation renal stones at various locations of a renal system.

[0036] FIGS.5A-5B illustrate examples of pulse waveforms of laser pulses under a high retropulsion setting.

[0037] FIGS.6A-6B illustrate examples of laser pulse train with distinct characteristics or patterns that can promote creation of vapor bubbles at the vicinity of a target structure.

[0038] FIG.7 illustrates an exemplary computer-based clinical decision support system (CDSS) that is configured to determine a proper laser retropulsion setting based on image or video features of the target structure.

[0039] FIG.8 is a flow chart illustrating an example method for operating a surgical laser system with a controlled retropulsion setting to manipulate and ablate a calculi structure in an anatomical environment.

[0040] FIG.9 is a block diagram illustrating an example machine upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. DETAILED DESCRIPTION

[0041] Laser endoscopy is a medical procedure of viewing and operating on an internal organ, and delivering surgical laser to a target body region to achieve a particular diagnostic or therapeutic effect. Laser endoscopy has been used in treatment of soft and hard tissue (e.g., damaging or destroying cancer cells) or lithotripsy procedures. Laser lithotripsy can break apart renal stones so that it can pass through the ureter. In PCNL, a practitioner can insert a rigid scope through an incision in a patient’s back and into the patient’s kidney. Through the scope, the practitioner can locate certain stones in the kidney or upper ureter, break the stones into smaller fragments by illuminating the stone, through the scope, with relatively high-powered infrared laser beam. The laser beam can ablate a stone into smaller fragments, which can be removed from the kidney. The scope can include an endoscope, a nephroscope, and / or a cystoscope.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0042] Renal stones can be found in many locations along the urethra, ureter and kidney. Endoscopic laser lithotripsy may cause renal stones to be trapped anywhere in the kidney, the ureter, or other parts of the urinary system. Stones stuck in the ureter may cause blockage and back-up of urine into the kidney, causing severe pain, infection, or other complications.

[0043] Renal stones in certain “convenient” locations such as major or minor calyx of kidney are less likely to move around or migrate to other parts of kidney or ureter when receiving endoscopic laser treatment. However, renal stones may not always be located at the convenient locations. For example, renal pelvic stones or ureteral stones, when receiving laser treatment, may move around, flip, and migrate to other parts of the renal system. This may lead to several consequences. First, with stone target moving around, lasers may be inadvertently fired at unintended region such as healthy tissue surrounding the calculi target, causing tissue damage. Second, the stone migration may require constant repositioning of laser fiber tip to better treat and remove residual calculi, which can be technically difficult, reduce ablation efficiency, and increase operative time. Third, stone fragments and residues scattering and migrating to other parts or sensitive structures of the kidney or urinary tract and need to chased and searched for further treatment, which may add procedure difficulty and time, and raise the chance of infection, tissue injury, or other complications.

[0044] Holmium:Yttrium-Aluminium-Garnet (Ho:YAG) laser lithotripsy has become the standard for treating urinary stones. However, despite its advantages, Ho:YAG lithotripsy has an inherent limitation of high stone retropulsion effect on the stone target being treated. The laser-generated retropulsion force may be caused by stone particles being released from the laser’s impact crater, and by fluid turbulences during vapor bubble formation at the laser fiber tip when there is no impact on the stone. Laser-generated retropulsion may result in a reduction of the stone ablation rate, increased operative time, decreased stone-free rates, and need for ancillary procedures with concomitant morbidity and healthcare costs.

[0045] Thulium lasers have been used in laser lithotripsy due to its greater capability of rapidly breaking stones and a reduced retropulsion effectClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 than Ho:YAG lasers. The low retropulsion makes the thulium fiber much easier to handle, without the need to constantly reposition the fiber tip in relation to its target. Additionally, thulium lasers generally require lower energies than the Ho:YAG laser to achieve precision fragmentation and dusting.

[0046] The present inventors have recognized an unmet need for an endoscopic laser lithotripsy system with more versatile and flexible control of retropulsion effect during a laser lithotripsy procedure. In particular, the present inventors have recognized that, despite the improved ablation efficiency and procedure safety associated with the thulium laser, in certain occasions particularly when the renal stones are located at inconvenient locations in the kidney or the urinary tract, high retropulsion effect can be effectively utilized to mobilize and manipulate the renal stones in a controlled manner, causing them to migrate to a more convenient location such as major or minor calyx of kidney. Once the target structure is ideally placed at the convenient location, laser pulses may be delivered under a low retropulsion laser setting to provide efficient stone ablation, fragmentation, and dusting.

[0047] Described herein are systems, devices, and methods for controlling stone retropulsion during a laser lithotripsy procedure. An exemplary surgical laser system comprises a laser system to provide laser pulses to a calculi structure in an anatomical environment, and a controller circuit to localize the calculi structure in the anatomical environment. If it is determined that the calculi structure is not at a target convenient location (e.g., major or minor calyx of kidney), the laser system can emit first laser pulses according to a first laser output setting, which produces a high retropulsion effect to mobilize and chase the calculi structure to the target convenient location in a controller manner. For calculi structure located at or pushed by retropulsion force to the target convenient location, the laser system can emit second laser pulses according to a second laser output setting, which produces a lower retropulsion effect than the first laser pulses but a higher efficiency to ablate or fragment the calculi structure. The adjustable laser output setting, particularly the dual retropulsion settings as descried herein, takes the advantage of high retropulsion force that can cause controlled movement of the calculi structure and the advantage of lowClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 retropulsion laser that provides efficient ablation the calculi structure without inadvertent incident on non-target healthy tissue. Accordingly, the systems and methods implementing such dual retropulsion laser settings allows more precise and effective therapy control, reduces procedure time, and improves laser therapy efficiency.

[0048] FIG.1 is a block diagram illustrating an example of a laser energy delivery system 100 configured to provide laser treatment to an anatomical target at or near a target structure 122 in a body of a subject, such as anatomical structure (e.g., soft tissue, hard tissue, or abnormal such as cancerous tissue) or calculi structure (e.g., kidney or pancreobiliary or gallbladder stone). In some examples, the laser energy delivery system 100 may deliver precisely controlled therapeutic treatment of tissue or other anatomical structures (e.g., tissue ablation, coagulation, vaporization, or the like) or treatment of non- anatomical structures (e.g., ablation or dusting of calculi structures).

[0049] The laser energy delivery system 100 can include a feedback control system 101, and at least one laser system 102 in operative communication with the feedback control system 101. By way of example and not limitation, FIG.1 shows the laser feedback system connected to a first laser system 102 and optionally (shown in dotted lines) to a second laser system 104. Additional laser systems are contemplated within the scope of the present disclosure. The first laser system 102 may include a first laser source 106, and associated components such as power supply, display, cooling systems and the like. The first laser system 102 may also include a first optical pathway 108 operatively coupled with the first laser source 106. In an example, the first optical pathway 108 includes an optical fiber. The first optical pathway 108 may be configured to transmit laser beams from the first laser source 106 to the target structure at or near a target structure 122.

[0050] The feedback control system 101 may receive feedback signals 130 from the target. Various feedback signals may be used to control laser delivery, laser energy output, and / or other system parameters to improve therapy efficacy and to achieve or maintain a desired condition such as a desired temperature at or near the surgical site to prevent or reduce the severity of laser- induced tissue thermal damage. In an example, the feedback signals 130 mayClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 include signals indicative of surgical site condition such as a temperature or a pressure at or near the surgical site during the procedure. In an example, the feedback signals 130 may include an acoustic signal produced by a laser pulse propagating through the media (e.g., liquid and vapor), projecting to the target and causing the target to vibrate. In another example, the feedback signals 130 may include reflected electromagnetic signal (e.g., reflected illumination light emitted from a light source). In yet another example, the feedback signals 130 may include reflected laser signal. The feedback control system 101 may analyze the feedback signals 130, generate signal properties from the feedback signals 130, and control laser output (e.g., energy intensity, or other laser irradiation parameters such as power, duration, frequency, or pulse shape, exposure time, or firing angle) or other system parameters according to the signal properties. In an example, the feedback signals 130 may include images or video frames of at least a portion of the surgical site such as generated by an imaging sensor during a procedure. The feedback control system 101 may analyze the images or the video frames to determine whether a degree of heat built up in a first target (e.g., tissue) at the surgical site exceeds a predetermined threshold. The predetermined threshold, which can be different for different types of tissue, can be represented by a threshold temperature (e.g., 42oC) that starts to cause undesirable clinical effects on the tissue. As there is a positive correlation between the degree of tissue whitening and the degree of heat buildup, the degree of heat buildup can be inferred by evaluating the degree tissue whitening in the first target, and the predetermined threshold for heat buildup can be represented by a threshold degree of tissue whitening. Based on the determination of the degree of heat buildup (e.g., tissue whitening at the first target), the feedback control system 101 may adjust laser output or laser delivery and / or other system parameters to achieve or maintain a treatment effect of a second target (e.g., a calculi structure) at the surgical site different from the first target, while avoid damaging the first target during the procedure. In an example, the first target can be tissue in a urinary system, and the second target can be a renal calculi structure. The feedback control system 101 may adjust laser output or laser delivery and / or other system parameters to achieve or maintain a desired surgical site condition, such as a desired surgical site temperature during a lithotripsy procedure toClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 prevent or reduce the severity of laser-induced tissue thermal damage, while maintain a treatment effect of ablating or fragmenting the renal calculi structure.

[0051] As shown in FIG.1, based on the analysis of the feedback signals 130, the feedback control system 101 may control the first laser system 102 and / or the second laser system 104 to generate suitable laser outputs to achieve a desired therapeutic effect and to achieve or maintain a desired condition such as a desired temperature at or near the surgical site to prevent or reduce the severity of laser-induced tissue thermal damage. For instance, the feedback control system 101 may monitor properties of the target structure during a therapeutic procedure (e.g., ablating calculi such as renal stones into smaller fragments) to determine if the tissue was suitably ablated prior to another therapeutic procedure (e.g., coagulation of blood vessels).

[0052] In an example, the first laser source 106 may be configured to provide a first output 110. The first output 110 may extend over a first wavelength range, such as one that corresponds to a portion of the absorption spectrum of the target structure. The first output 110 may provide effective ablation and / or carbonation of the target structure since the first output 110 is over a wavelength range that corresponds to the absorption spectrum of the tissue.

[0053] In an example, the first laser source 106 may be configured such that the first output 110 emitted at the first wavelength range corresponds to high absorption (e.g., exceeding about 250 cm-1) of the incident first output 110 by the tissue. In example aspects, the first laser source 106 may emit first output 110 between about 1900 nanometers (nm) and about 3000 nm (e.g., corresponding to high absorption by water) and / or between about 400 nm and about 520 nm (e.g., corresponding to high absorption by oxy- hemoglobin and / or deoxy-hemoglobin). Appreciably, there are two main mechanisms of light interaction with a tissue: absorption and scattering. When the absorption of a tissue is high (absorption coefficient exceeding 250 cm-1) the first absorption mechanism dominates, and when the absorption is low (absorption coefficient less than 250 cm-1), for example lasers at 800-1100 nm wavelength range, the scattering mechanism dominates.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0054] Various commercially available medical-grade laser systems may be suitable for the first laser source 106. For instance, semiconductor lasers such as InXGa1-XN semiconductor lasers providing the first output 110 in the first wavelength range of about 515 nm and about 520 nm or between about 370 nm and about 493 nm may be used. Alternatively, infrared (IR) lasers such as those summarized in Table 1 below may be used. Table 1 Example List of suitable IR lasers

[0055] The optional second laser system 104 may include a second laser source 116 for providing a second output 120, and associated components, such as power supply, display, cooling systems and the like. The second laser system 104 may either be operatively separated from or, in the alternative, operatively coupled to the first laser source 106. In some embodiments, the second laser system 104 may include a second optical pathway 118 (separate from the first optical pathway 108) operatively coupled to the second laser source 116 for transmitting the second output 120. Alternatively, the first optical pathway 108 may be configured to transmit both the first output 110 and the second output 120.

[0056] In certain aspects, the second output 120 may extend over a second wavelength range, distinct from the first wavelength range. Accordingly, there may not be any overlap between the first wavelength range and the second wavelength range. Alternatively, the first wavelength range and the second wavelength range may have at least a partial overlap with each other. In advantageous aspects of the present disclosure, the second wavelength range may not correspond to portions of the absorption spectrum of the target structure where incident radiation is strongly absorbed by tissue that has not been previously ablated or carbonized. In some such aspects, the second output 120 may advantageously not ablate uncarbonized tissue. In another embodiment, the second output 120 may ablate carbonized tissue that has been previously ablated. In additional embodiments, the second output 120 may provide additionalClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 therapeutic effects. For instance, the second output 120 may be more suitable for coagulating tissue or blood vessels.

[0057] In some examples, the first laser source 106 and the second laser source 116 may each operate under respective laser output settings corresponding to distinct retropulsion effects on a calculi target. In an example, the first laser source 106 is a Ho:YAG laser source configured to produce the first output 110 with a high retropulsion effect, and the second laser source 116 is a thulium laser source configured to provide the second output 120 with a lower retropulsion effect than the first output 110. The thulium laser thus generated also has a higher target ablation efficiency than the Ho:YAG laser. In another example, the first laser source 106 and the second laser source 116 may be of the same type, or alternatively be merged into one laser source (e.g., a thulium laser source) with configurable or adjustable laser output settings, such that the first output 110 produced under the first output setting has a high retropulsion effect than the second output 120 produced under the second output setting.

[0058] The feedback control system 101 may select between the high- retropulsion laser source (e.g., a Ho:YAG laser source) and the low-retropulsion laser source (e.g., a thulium laser source) in the case of dual laser sources, or select between a high-retropulsion setting and a low retropulsion setting in the case of a single laser source (e.g., a thulium laser source), based at least in part on the location of the calculi structure with respect to a desired “convenient” location. For example, if it is determined that the calculi structure is not at a target convenient location, then the feedback control system 101 may activate the high-retropulsion laser source and deactivate the low-retropulsion laser source, or cause the single laser source to operate under the high-retropulsion setting, to emit the first output 110 to mobilize and chase the calculi structure to a desired “convenient” location in the anatomical environment. For calculi structure located at or pushed by retropulsion force to the desired convenient location, the feedback control system 101 may activate the low-retropulsion laser source and deactivate the high-retropulsion laser source, or switch to the high-retropulsion setting of the single laser source, to emit the second output 120Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 to ablate the calculi structure with little retropulsion effect at the desired convenient location.

[0059] FIG.2 is a block diagram illustrating an example surgical laser system 200 with a controlled retropulsion setting, and at least a portion of the environment in which the system 200 may operate. The system 200 can be an embodiment of the laser energy delivery system 100, or a lithotripsy system that may be used for destructing hardened masses like renal stones, bezoars, gallstone, among other calculi structures.

[0060] The surgical laser system 200 may include a feedback control system 210, one or more sensors 220, a laser system 230, and a user interface device 250. The feedback control system 210, which is an embodiment of the feedback control system 101 of FIG.1, can include a feedback analyzer 212 and a controller circuit 214. According to example embodiments, the feedback control system 210 may include processors, such as microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components for performing one or more of the functions attributed to the feedback control system 210.

[0061] The feedback analyzer 212 may be communicatively coupled to one or more sensors 220, receive therefrom sensor signals, and generate one or more signal properties from the sensor signals that may be used in target detection, localization, and / or identification, which may further be used for adjusting a laser output setting. By way of example and as illustrated in FIG.2, the one or more sensors 220 may include at least one of a spectroscopic sensor 222, an imaging sensor 224, or an acoustic sensor 226. The spectroscopic sensor 222 can sense a spectroscopic signal from the target structure 122, and generate one or more spectroscopic properties from the spectroscopic signal. The spectroscopic properties may include characteristics such as reflectivity, reflectance spectrum, absorption index, and the like. Examples of the spectroscopic sensor 222 may include a Fourier Transform Infrared (FTIR) spectrometer, a Raman spectrometer, a UV-VIS spectrometer, a UV-VIS-IR spectrometer, or a fluorescent spectrometer, among others. Each spectroscopicClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 sensor 222 corresponds to a spectroscopy technique. For example, UV-VIS reflection spectroscopy may be used to gather information from the light reflected off an object similar to the information yielded from the eye or a color image made by a high resolution camera, but more quantitatively and objectively. The reflection spectroscopy may offer information about the material since light reflection and absorption depends on its chemical composition and surface properties. Information about both surface and bulk properties of the sample may be obtained using this technique. The reflection spectroscopy may be used to recognize composition of hard or soft tissue. Fluorescent spectroscopy is a type of electromagnetic spectroscopy that analyzes fluorescence from a sample. It involves using a beam of light, usually ultraviolet, that excites a material compound and causes the material compound to emit light, typically in visible or IR area. The method may be applied for analysis of some organic components such as hard and soft tissue. FTIR spectroscopy may be used for rapid materials analysis, and has relatively good spatial resolution and gives information about the chemical composition of the material. Raman spectroscopy may be used for identifying hard and soft tissue components. As a high spatial resolution technique, it is also useful for determining distribution of components within a target. The spectroscopy techniques as described above may be used alone or in combination to analyze the spectroscopic signal by the spectroscopic sensor 222 to generate one or more spectroscopic properties indicative of structure types with respective distinct compositions.

[0062] The imaging sensor 224 can generate images or video frames of at least a portion of the target structure 122 during the procedure. The imaging sensor 224 may be included in an imaging system that further includes a lens system. The imaging sensor 224 may take the form of an imaging camera, such as a CCD or CMOS camera sensitive in ultraviolet (UV), visible (VIS) or infrared (IR) wavelengths in an embodiment. In some embodiments, the spectroscopic sensor 222 may include more than a single type of spectrometer or imaging camera listed herein to enhance sensing and detection of various features (e.g., carbonized and non-carbonized tissue, vasculature, and the like). The imaging sensor 224 may be located a distal portion of an endoscope for useClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 during the procedure, an example of which is illustrated in FIG.3. The imaging sensor 224 may generate images or video frames at different times.

[0063] The acoustic sensor 226 can sense an acoustic signal in response to an excitation signal (e.g., laser pulses) incident on the target structure. The acoustic signal may be sensed when laser pulses propagate through liquid media along the path to the target structure and cause the liquid to vibrate. In some examples, the acoustic sensor 226 may sense sound waves with specific wavelengths, such as audible range of waves, ultrasonic wave, or infrasonic waves. Examples of the acoustic sensor 226 may include microphones, hydrophones, capacitive sensors, piezoelectric sensor, piezoceramic sensor, fiber-optic sensors, or solid-state acoustic detectors, among others. The feedback analyzer 212 may analyze the acoustic signals to generate one or more acoustic properties. Examples of the acoustic properties may include intensity, power, frequency or spectral content, or a graphical feature representing a shape of the received acoustic signal (e.g., a shape characteristic of a time series of sound intensity). In some examples, the acoustic properties may include one or more statistical features (e.g., signal mean or variance) of the received acoustic signal.

[0064] The feedback analyzer 212 may detect, localize, and identify the target structure 122 using the sensor signals or signal properties from the one or more sensors 220. In an example, the feedback analyzer 212 may use the sensed images or video frames to determine the location of the target structure 122 in an anatomical environment, such as a renal stone in a patient’s renal system. In some examples, the feedback analyzer 212 may use one or more spectroscopic, imaging, or acoustic properties to identify the target structure 122 as one of a plurality of structure categories, such as a category of calculi structure, or a category of anatomical structure. The signal properties may include intensity, power, frequency or spectral content, a graphical feature or shape, or one or more statistical features of the received spectroscopic sensor signal, imaging sensor signal, or acoustic signal. For a tissue target or a calculi structure, its ability to absorb laser energy depends on its composition and liquid content. Different target types, such as different calculi structures or soft or hard tissue, may have different composition and / or liquid content. When these targets absorb different amount of laser energy, they may produce respective differentClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 spectroscopic properties and / or acoustic properties. Examples of calculi structure may include stones or stone fragments in various stone-forming regions such as urinary system, gallbladder, nasal passages, gastrointestinal tract, stomach, or tonsils. Examples of the anatomical structure may include soft tissue (e.g., muscles, tendons, ligaments, blood vessels, fascia, skin, fat, and fibrous tissues), hard tissue such as bone, connective tissue such as cartilage, among others.

[0065] In an example, the feedback analyzer 212 may identify the target structure 122 as one of a plurality of structure types of the same category, such as a particular tissue type within an identified category of anatomical structure, or as a particular calculi type within an identified category of calculi structure. In another example, the feedback analyzer 212 may identify a calculi structure as one of stone types with distinct chemical compositions, such as one of a CaP stone, a MAP stone, a COM stone, a COD stone, a cholesterol-based stone, or a uric acid (UA) stone. The target identification may be made based on one or more of spectroscopic properties or acoustic properties, such as intensity, power, frequency or spectral content, or a graphical feature or shape of the spectroscopic or acoustic signal, or one or more statistical features generated from the spectroscopic or acoustic signal. In some example, the feedback analyzer 212 may identify the target structure as one of plurality of tissue types. The tissue types may include tissue at distinct anatomical locations, such as calyx tissue, cortex tissue, medulla tissue, ureter tissue, or bladder tissue. In another example, the feedback analyzer 212 may identify an target structure as normal tissue or abnormal tissue (e.g., cancerous tissue). In another example, the feedback analyzer 212 may identify an target structure as a treatment area (e.g., tumor or polyp intended for removal) or a non-treatment area (e.g., blood vessels, muscle, etc.).

[0066] The controller circuit 214 may be coupled by wired or wireless connections to the feedback analyzer 212. The controller circuit 214 may dynamically determine or adjust a laser retropulsion setting 216 based at least in part on the feedback received from the feedback analyzer 212, such as location, type, composition, or other characteristics of the target structure identified during the procedure. In some examples, such feedback-controlled dynamic adjustment of the laser retropulsion setting 216 may be performed continuouslyClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 or intermittently (e.g., at specified times) during the procedure. Laser pulses in accordance with the retropulsion setting 216, when incident on the target structure 122, may produce a desired retropulsion effect on the target. As described above, laser-generated retropulsion force is generally caused by stone particles being released from the lasers’ impact crater, and by fluid turbulences during vapor bubble formation at the laser fiber’s tip when there is no impact on the renal stone. In an example, the controller circuit 214 may determine a laser retropulsion setting 216 based on the location of the target structure 122 in the anatomical environment. In an example, the location of the target structure 122 may be determined based on the image or video frames of the target structure 122. If it is determined that the target structure 122 is located at a location other than a specific desired “convenient” location, then the controller circuit 214 may set the laser retropulsion setting 216 to a high retropulsion setting, such that the laser system 230 emits first laser pulses with a high retropulsion effect to mobilize and chase the calculi structure to the desired “convenient” location. If the target structure 122 is located at or pushed by retropulsion force to the desired convenient location, then the controller circuit 214 may switch the laser retropulsion setting 216 to a low retropulsion setting, such that the laser system 230 emits second laser pulses with a low retropulsion effect to ablate the calculi structure 122 with little retropulsion effect at the desired convenient location.

[0067] In some examples, the controller circuit 214 may determine or select a proper laser retropulsion setting using artificial intelligence (AI) or machine learning (ML) based techniques. For example, image or video frames of the target structure 122 or features extracted therefrom may be applied to a trained ML model to automatically recognize location, type, composition, or other characteristics of the target structure identified during the procedure. The recognized characteristics may be used to determine or adjust the laser retropulsion setting 216, as stated above. In some examples, the image or video frames of the target structure 122 and / or the feedback information received from the feedback analyzer 212 may be applied to a trained ML model to directly determine a proper laser retropulsion setting. Examples of using a trained ML model to determine a laser retropulsion setting are discussed below with respect to FIG.7.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0068] Referring to FIG.4, the diagram therein illustrates renal stones at different locations of a patient’s renal system, including, for example, calyceal stones 410 at major or minor calyx of kidney, pelvic stones 420 at renal pelvis, or ureteral stones 430 typically at upper ureter. Generally, major and minor calyces may be selected as desired “convenient” locations because they form a “dead end” or a tight space that entraps and stabilizes stones or stone fragments. Renal stones or stone fragments at such “convenient” locations (e.g., the calyceal stones 410) are unlikely move around when treated with laser pulses, and the surrounding non-target or healthy tissue can be spared from inadvertent laser firing. In contrast, renal pelvis and ureter are generally considered “inconvenient” locations, because ablation laser pulses are more likely to cause renal stones or stone fragments therein (e.g., the pelvic stones 420 or the ureteral stones 430) to move round and migrate to other renal locations. The feedback analyzer 212 may adjust the laser retropulsion setting 216 to a high retropulsion setting, such that the laser system 230 emits first laser pulses with a high retropulsion effect to mobilize and chase the pelvic stones 420 or the ureteral stones 430 (or stone fragments located at inconvenient locations like the renal pelvis or the upper ureter) to the desired “convenient” location. If the target structure 122 is located at or pushed by retropulsion force to the desired convenient location, then the controller circuit 214 may switch the laser retropulsion setting 216 to a low retropulsion setting, such that the laser system 230 emits second laser pulses with a low retropulsion effect but a higher ablation efficiency to ablate the calculi structure 122 with little retropulsion effect.

[0069] Referring back to FIG.2, the laser system 230, which is an example of the laser system 102 or the laser system 104 as shown in FIG.1, can include a laser source (such as the first laser source 106) and an optical pathway (such as the first optical pathway 108) for directing the laser energy to the surgical site. The laser source can generate laser energy in accordance with a laser output intensity or one or more laser irradiation parameters (e.g., one or more laser pulse parameters such as, power, duration, frequency, or pulse shape, exposure time, or firing angle). At least some of such laser parameters are programmable or adjustable either automatically such as by the controller circuit 214, or manually by a user via the user interface device 250.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0070] In an example, the laser system 230 may include two laser sources, such as the first laser source 106 and the second laser source 116, as described above with respect to FIG.1. The two laser sources may each operate under respective laser retropulsion settings with distinct retropulsion effects. In an example, the two laser sources include a Ho:YAG laser source and a thulium laser source. The Ho:YAG laser source can produce laser pulses with a high retropulsion effect, the thulium laser source can produce laser pulses with a lower retropulsion effect but a higher target ablation efficiency than the Ho:YAG laser source. In another example, the laser system 230 may include one laser source, such as a thulium laser source, with a configurable or adjustable laser retropulsion setting, such as a high retropulsion setting and a low retropulsion setting. Laser pulses under the high retropulsion setting have a high retropulsion effect on stones or fragments located at “inconvenient” locations (e.g., the pelvic stones 420 or the ureteral stones 430).

[0071] In an example of thulium laser, high retropulsion setting may include a specific pulse waveform. FIGS.5A-5B illustrate example pulse waveforms of thulium laser produced under a high retropulsion setting. The laser pulses may produce a high retropulsion effect on a target structure. In particular, FIG.5A illustrates a rectangular laser pulse waveform 500A with predetermined pulse amplitude and pulse width. In a non-limiting example, the pulse amplitude is approximately 500 Watts, and the pulse width is approximately 0.8 milliseconds (msec). FIG.5B illustrates a descending triangle laser pulse waveform 500B with predetermined pulse peak amplitude, descending rate, and pulse duration. In a non-limiting example, the pulse peak amplitude is approximately 500 Watts, the pulse duration is approximately 1.6 msec. Experiments performed by the present inventors have demonstrated that thulium laser pulses with such pulse waveforms as illustrated in FIGS.5A-5B can produce high retropulsion force and activate substantial motion of a calculi target. The high retropulsion setting allows a user (e.g., endoscopist) to more efficiently manipulate the renal stones until they reach a desired “convenient” location, where laser pulses with low retropulsion setting may be utilized to ablate and fragment the renal stones. In one example, laser pulses with low retropulsion setting can have a pulse profile with a peak power of between 200Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 and 400 Watts, and a pulse energy between 0.025 and 3 Joules. In another example, laser pulses with low retropulsion setting can have multiple pulse profile including at least one low intensity (for example, between 90 and 400 Watts peak power) pulse containing between 0.05 and 0.2 Joules of energy, a short period ( e.g., less than 0.15 Joules) of low or no peak power (e.g., less than 150 Watts) emission, and at least one high intensity rectangular pulse (e.g., greater than 200 Watts peak power) containing greater than 0.05 Joules of energy.

[0072] In some examples, the laser retropulsion setting 216 may include adjustable pulse amplitude or pulse width of a laser pulse train. A laser pulse train with specific characteristics or patterns (e.g., specific intensity and / or pulse width) may promote formation of vapor bubbles at the vicinity of the target structure 122, which may enhance the high retropulsion effect on the target structure 122. Referring to FIGS.6A-6B, the diagrams therein illustrate examples of laser pulse train that can promote formation of vapor bubbles. FIG. 6A illustrates a first pulse train 600A with a first pulse amplitude A1and a first pulse width W1. FIG.6B illustrates a second pulse train 600B with a second pulse amplitude A2and a second pulse width W2. The first pulse amplitude A1is lower than the second pulse amplitude A2, and the first pulse width W1is longer than the second pulse amplitude W2. For stones or fragments located at an “inconvenient” location (e.g., the pelvic stones 420 or the ureteral stones 430), the first pulse train 600A may be controllably applied to the target structure 122 such as a renal stone in a fluid environment. The low pulse amplitude A1and long pulse width W1of the first pulse train 600A may facilitate formation of vapor bubbles with a relatively small volume between the laser fiber tip and the target structure 122. The pulse width W1is long enough to allow the laser pulse to significantly heat the surface of the target structure 122 where the laser energy is incident. Accordingly, the fist pulse train 600A may help create vapor bubbles that mobilize the target structure 122 and push it away from its current location.

[0073] The second pulse train 600B may be controllably applied to the target structure 122 such as a renal stone in a fluid environment. With very high pulse amplitude A2and very short pulse width W2, the second pulse train 600B may rapidly create a large vapor bubble between the laser fiber tip and the targetClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 structure 122. The vapor bubble is large enough so as to consume the heated portion of the target structure 122. The formation of vapor bubbles with the use of the pulse trains 600A and / or 600B can produce fluid turbulence that mobilizes the target structure 122 and causes controlled migration from an inconvenient location to a desired, convenient location.

[0074] In addition to the vapor bubbles created by laser pulse trains 600A or 600B, laser-generated high retropulsion effect may be enhanced by controlled collapse of vapor bubbles. In an example, in the presence of the vapor bubbles such as created by laser pulse trains 600A or 600B, the controller circuit 214 may temporarily stop laser emission from the laser source, or adjust one or more of the pulse amplitude or the pulse width of the laser pulse train 600A or 600B, to facilitate collapse of the vapor bubbles at a distance away from the target structure 122. The collapse of vapor bubbles may produce a propulsion force against a surface of the target structure 122, thereby mobilizing and pushing the target structure 122 away from its current location. Examples of using a laser pulse train with specific characteristics or patterns to form vapor bubbles and / or to facilitate collapse of the vapor bubbles to enhance retropulsion effect on a target structure will be discussed further with respect to FIG.3.

[0075] In some examples, the laser system 230 may be associated with one of two distinct operating modes or states: a first state wherein the laser system 230 generates a laser output, and a second state where a laser system 230 does not generate a laser output. For instance, the first laser system 102 may have a first state where a first output 110 (e.g., over the first wavelength range) is generated, and a second state where the first output 110 is not generated. Similarly, the second laser system 104 may have a first state where a second output 120 (e.g., over the second wavelength range) is generated, and a second state where the second output 120 is not generated. In such embodiments, the controller circuit 214 may control the laser system 230 by sending control signals that change the operating state the laser system from the first state to the second state, or from the second state to the first state. In some examples, the laser system 230 may have additional states, for instance, a third state where a laser output in accordance with a different laser irradiation parameter setting is generated. Accordingly, additional control signals may be sent by the controllerClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 circuit 214 to the laser system(s) to change their states from their current state to one or more additional states (e.g., first state to third state, second state to third state, third state to first state, and third state to second state) to generate laser outputs that provide a desired therapeutic effect.

[0076] In an example, the controller circuit 214 may generate a control signal to operate the laser system 230 in a first operating mode if the target is identified as a calculi structure, or a second operating mode if the target is identified as an anatomical structure, or a third operating mode if the target is identified as neither an anatomical structure nor a calculi structure. In an example, the first operating mode may include activating the laser system 230 to deliver a laser beam programmed with a first irradiation parameter setting to ablate or dust the identified calculi, such as renal stones. In an example, the second operating mode may include withholding laser delivery, or delivering a laser beam programmed with a second irradiation parameter setting different from the first irradiation parameter setting to an identified tissue. In an example, the third operating mode may include deactivating the laser system 230 from delivery of laser energy. The laser irradiation parameters may include wavelength, power, power density, pulse parameters (e.g., pulse width, pulse rate, amplitude, duty cycle), exposure time, total dose or energy, among others.

[0077] In some examples, the controller circuit 214 may determine the operating mode of the laser system 230 based on an identification of the target structure 122 as one of a plurality of calculi types, such as CaP stone, a MAP stone, a COM stone, a COD stone, a cholesterol-based stone, or a uric acid (UA) stone, as determined by the feedback analyzer 212. The controller circuit 214 may adjust the irradiation parameter setting based on the identification of calculi type, and generate a control signal to control the laser system 230 to deliver laser energy to the target structure 122 in accordance with the adjusted irradiation parameter setting.

[0078] In some examples, the controller circuit 214 may determine the operating mode of the laser system 230 based on the identification of the target structure 122 as one of a plurality of tissue types, such as renal tissue at different anatomical locations (e.g., calyx tissue, cortex tissue, medulla tissue, ureter tissue, or bladder tissue), normal or abnormal tissue (e.g., cancerous tissue),Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 treatment area (e.g., tumor or polyp intended for removal) or a non-treatment area (e.g., blood vessels, muscle, etc.). The controller circuit 214 may adjust the irradiation parameter setting based on the identification of tissue type, and generate a control signal to the laser system 230 that delivers laser energy to the identified anatomical structure in accordance with the adjusted irradiation parameter setting.

[0079] In some examples, the controller circuit 214 may adjust the irradiation parameter setting directly based on one or more of the spectroscopic properties or acoustic properties produced by the feedback analyzer 212 without using information about target type or target composition such as generated by the feedback analyzer 212. For example, the intensity of the feedback signal produced in response to laser firing at a target calculi structure is correlated to laser power density. The controller circuit 214 may automatically adjust an irradiation parameter setting (e.g., laser power) and laser fiber position to achieve a desired feedback signal amplitude.

[0080] In various examples, the feedback analyzer 212 may continuously monitor the target structure 122, collect and analyze feedback signals, and continuously communicate with the controller circuit 214. Accordingly, the controller circuit 214 may continue maintaining the laser systems in one or more states until a change in the feedback is detected (e.g., a different category of the target structure 122, a different tissue type, or a different calculi type). When a change in feedback is detected, the controller circuit 214 may communicate with the one or more laser systems and change their state(s) to deliver a desired therapeutic effect. Alternatively or additionally, the controller circuit 214 may communicate with an operator (e.g., healthcare professional), and display one or more output(s) via one or more output system(s) indicative of the feedback signal, and may, optionally, instruct the operator to perform one or more treatment procedures with the first laser system and / or the second laser system to deliver a desired therapeutic effect.

[0081] In illustrative examples described herein, the controller circuit 214 may control more than one laser system by changing the operating state of each laser system. According to an aspect, the controller circuit 214 may independently control each laser system. For instance, the controller circuit 214Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 may send a distinct control signal to each laser system to control each laser system independently of the other laser systems. Alternatively, the controller circuit 214 may send a common signal to control one or more laser systems.

[0082] The user interface device 250 may be operatively in communication with the feedback control system 210. The user interface device 250 may include an output / display unit 252 to display information including, for example, feedback signals sensed by the one or more sensors 220, target detection, localization, and identification results generated by the feedback analyzer 212, or current device settings such as the laser retropulsion setting 216 and laser irradiation parameters. The output / display unit 252 may display UI elements including visual elements, alerts, tactile feedback, or any combination thereof. The output / display unit 252 may generate an alert that a stone target is located at an inconvenient location. The alert may be presented in an audible, visible, tactile, or otherwise human-perceptible format.

[0083] The user interface device 250 may include one or more input units 254 to receive user programming of the device, such as parameter values used for analyzing sensor signals and for detecting target location and identifying target types. The user input may include a selection or programming of a laser retropulsion setting, laser irradiation parameters, among other device parameters.

[0084] In some examples, the output / display unit 252 may generate a recommendation to a user for selecting or altering a laser retropulsion setting, such as a recommended high retropulsion setting for mobilizing a stone target at an inconvenient location and chasing the stone target to a desired convenient location, and / or a recommended low retropulsion setting for ablating, fragmenting, or dusting a renal stone that is located at or has been pushed to a desired convenient location. A user may provide an input via the one or more input units 254 to confirm, reject, or modify the recommended adjustment.

[0085] FIG.3 illustrates an example of an endoscopic laser lithotripsy system 300 with automatic surgical site condition control, which can be an example of the surgical laser system 200. The endoscopic laser lithotripsy system 300 may include an endoscope 301, a feedback control system 310, and an actuator 338. The endoscope 301 has a proximal portion and an elongateClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 distal portion that may be configured to be inserted into a surgical site of a patient during an endoscopic laser lithotripsy procedure. The endoscope 301 may provide visual inspection or treatment of soft (e.g., non-calcified) or hard (e.g., calcified) tissue as well as for visualizing or breaking up or otherwise treating renal stones or other calculi structures or targets.

[0086] As illustrated in FIG.3, the endoscope 301 may include or provide visualization and illumination optics, such as a visualization optical pathway 360 and an illumination optical pathway 350, each of which may extend longitudinally along the elongate body of the endoscope 301. An eyepiece or camera or imaging display may be provided at or coupled to the visualization optical pathway 360 to permit user or machine visualization of a target region at or near a distal end of the endoscope 301. The target region may be illuminated by light 370, such as provided by an illumination light source 324 at a proximal end of the illumination optical pathway 350 and emitted from a distal end of the illumination optical pathway 350. The light source 324 can include, for example, a Xenon lamp, a light-emitting diode (LED), a laser diode (LD), or any combination thereof. In an example, the light source 324 may include two or more light sources that emit light having different illumination characteristics, referred to as illumination modes. In an example, the illumination modes may include a white light illumination mode, or a special light illumination mode such as a narrow band imaging mode, an auto fluorescence imaging mode or an infrared imaging mode. A special light illumination can concentrate and intensify specific wavelengths of light, for example, resulting in a better visualization of tissue or other structures at the surgical site.

[0087] The lithotripsy system 300 may include or be coupled to a laser source 332, which may be an example of the first laser source 106, the second laser source 116, or the laser system 230. The laser source 332 may be included in the laser system 230, and mechanically and optically connected to an optical pathway 334, which may include a single optical fiber or a bundle of optical fibers. The optical pathway 334, which is an embodiment of the first optical pathway 108 or the second optical pathway 118, or the optical pathway included in the laser system 230, may be introduced via a proximal access port to extendClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 within a working channel or other longitudinal passage or lumen of the endoscope 301 or similar instrument.

[0088] In some examples, the laser source 332 may include a first laser source to generate a treatment beam and a second different laser source to generate an aiming beam. The treatment beam and the aiming beam can be directed to the target through the same or a different optical pathways. In some examples, the aiming beam may be generated using a light source different than the second laser source. The aiming beam may have a distinct color (e.g., green or red) to distinguish from the illumined background of the surgical site.

[0089] The lithotripsy system 300 may include one or more sensors to sense information from the anatomical target or the surgical site, including a spectroscopic sensor 222. As described above with reference to FIG.2, the spectroscopic sensor 222 may sense a spectroscopic signal from the target structure 122. The spectroscopic sensor 222 may be located at a distal end 336 of the optical pathway 334. The feedback control system 310 includes a feedback analyzer 312 and a controller circuit 314. The feedback analyzer 312, which is an embodiment of the feedback analyzer 212, may include a spectrometer that generates one or more spectroscopic properties from a spectroscopic sensor signal, or one or more acoustic properties from an acoustic signal, as described above with respect to the feedback analyzer 212. The feedback analyzer 312 may detect, localize, and identify the target structure 122 using the spectroscopic signals or imaging signals. In an example, the feedback analyzer 312 may additionally recognize the target as a calculi structure or anatomical target at or near the surgical site, or classify the target as one type of tissue or one type of calculi of distinct composition using the one or more spectroscopic properties. In some examples, the feedback analyzer 312 may calculate or estimate the fiber- target distance using the spectroscopic properties. The controller circuit 314 may generate a control signal to the laser source 332 to adjust a laser output setting, a control signal to the actuator 338 to adjust the position or orientation of the distal end 336 of the optical pathway 334 based on the structure, composition, or type of the target.

[0090] The lithotripsy system 300 may include a camera or imaging device 325. The camera or imaging device 325 can include an imaging sensorClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 (such as the imaging sensor 224) that can generate an imaging signal 365 of the target in response to electromagnetic radiation (e.g., illumination light 370) of the target at or near the surgical site. The imaging signal 365 may be transmitted through the optical pathway 360, or alternatively through the optical pathway 334, to the feedback control system 310 (an embodiment of the feedback control system 210). In an example, the imaging signal 365 may pass through an optical splitter before reaching the feedback analyzer 312. The feedback analyzer 312 may use the imaging signal 365 to determine target location. The imaging signal 365 may also be used to assist in target identification, such as identifying a calculi structure or anatomical target at or near the surgical site, or classify the target as one type of tissue or one type of calculi of distinct composition.

[0091] The controller circuit 314 may generate a control signal to the laser source 332 to automatically adjust a laser output setting, including one or more laser irradiation parameters, based at least in part on the target identification (e.g., target location, type, and composition). In some examples, the controller circuit 314 may determine a laser retropulsion setting based on information about target type, location, and identification. If it is determined that the target structure 122 is situated an inconvenient location, then the controller circuit 314 may adjust the laser retropulsion setting to cause the laser source 332 to emit first laser pulses 383A with a high retropulsion effect to mobilize, manipulate, and cause migration of the calculi structure to a desired “convenient” location. For the target structure located at or pushed to the desired “convenient” location, the controller circuit 314 may adjust the laser retropulsion setting to cause the laser source 332 to emit second laser pulses 383B with a low retropulsion effect but a higher efficiency for ablating, fragmenting, or dusting the calculi structure. The adjustment of laser retropulsion setting may be achieved by using two distinct laser sources included in the laser source 332, such as a Ho:YAG laser source configured to produce laser pulses 383A with a high retropulsion effect, and a thulium laser source configured to produce laser pulses 383B with a lower retropulsion effect but a higher target ablation efficiency than the Ho:YAG laser source. Alternatively, the adjustment of laser retropulsion setting may be achieved using one laser source, such as a thuliumClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 laser source, with a configurable or adjustable laser retropulsion setting, including a high retropulsion setting and a low retropulsion setting.

[0092] Laser pulses 383A under the high retropulsion setting have a high retropulsion effect on stones or stone fragments. The high retropulsion effect may be achieved using different techniques. In one example, a high retropulsion setting can be configured by programming a specific pulse waveform of thulium laser, as described above with respect to FIGS.5A-5B. In another example, a laser pulse train with specific characteristics or patterns (e.g., specific intensity and / or pulse width), such as those illustrated in FIGS.6A-6B, may be used to promote formation of vapor bubbles 392 at the vicinity of the target structure 122. The formation of vapor bubbles may enhance the high retropulsion effect on the target structure 122.

[0093] The laser-generated high retropulsion effect may further be enhanced by controlled collapse of vapor bubbles. In the presence of the vapor bubbles, the controller circuit 314 may temporarily stop laser emission, or adjust one or more of the pulse amplitude or the pulse width of the laser pulse train, to facilitate bubble collapse 394 at a distance away from the target structure 122. For example, after creating vapor bubbles with the first laser pulse train 600A as shown in FIG.6A, a short halt of laser firing, or significantly reducing the laser pulse intensity, may provide time for the small vapor bubbles to start collapsing. The fluid from bubble collapsing may be utilized for the subsequent application of the second laser pulse train 600B as shown in FIG.6B. The high pulse amplitude and very short pulse width may help create a large vapor bubble rapidly. Following the creation of the large vapor bubble, a temporary stop of laser emission may permit the external liquid pressure to cause the large bubble to collapse. The residual laser-induced heat released from the target structure 122 may cause that portion of the vapor bubble to collapse slightly less quickly, therefore creating unequal pressure that has a net resultant propulsion force acting toward the target structure 122, which may mobilize and push the target structure 122 away from its current location to a desired convenient location.

[0094] In addition or alternative to adjusting laser output settings, in some examples, the controller circuit 314 may generate a control signal to an actuator 338 to adjust the position of the laser fiber distal end 336 relative to theClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 target structure 122. The actuator 338 may be a laser emitting end coupled to a portion of the optical pathway 334, and can be in electrical communication with the controller circuit 314. In an example, the actuator 338 may be located at or near the distal end of the endoscope 301. The actuator 338 may include one or more of an electromagnetic element, an electrostatic element, a piezoelectric element, or other actuating element such as to actuate or otherwise permit longitudinal or rotational positioning of the laser fiber distal end 336 with respect to the working channel or other longitudinal passage of the endoscope 301, or with respect to another reference location for which the endoscope 301 may serve as a frame of reference.

[0095] In some examples, the laser-generated high retropulsion effect may be enhanced by controlled withdrawal of the optical pathway 334 (e.g., the laser fiber) from the target structure 122 while delivering laser pulses under a high retropulsion setting (such as the laser pulses with the unique waveforms and parameters as shown in FIGS.5A-5B, or pulse trains as illustrated in FIGS.6A- 6B that promotes vapor bubble creation and bursts). For example, the laser fiber distal end 336 may be robotically withdrawn (e.g., via the actuator 338) at a controlled speed (e.g., via the controller circuit 314) away from the target structure 122. The laser pulses act directly against the target structure 122 to create heating, and then as the laser fiber moves backward, fluid filling the space may be vaporized to create large bubbles. Depending on how quickly the laser fiber is withdrawn, a cavitation effect may be created that may result in a significantly larger vapor bubble due to the water vapor contained in that low pressure cavitation bubble at the fiber tip 336 may be instantly heated at high temperature by the laser pulses.

[0096] The unique pulse waveforms as illustrated in FIGS.5A-5B, the pulse trains with distinct pulse amplitude and pulse width as illustrated in FIGS. 6A-6B, and the robotically controlled laser fiber movement as described above, may improve the creation of the vapor bubbles and the dynamics of bubble collapse. This may lead to more efficient and effective controlled migration of the target structure to a desired convenient location, where a low-retropulsion laser may be used to ablate and fragment the target structure.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0097] FIG.7 is a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 710 that is configured to determine a proper laser retropulsion setting based on image or video features of the target structure 122 (hereinafter the “input features”). In various embodiments, the CDSS 710 includes an input interface 712 through which the input features which are specific to a patient are provided to a trained ML model 714 (also referred to as an AI model) . The controller circuit 214 (shown in FIG.2) performs an inference operation in which the input features are applied to the ML model 714 to generate a laser retropulsion setting as an inference output at the output interface 716. The inference output may be output to an output device 740, which may include a user interface (UI) through which the laser retropulsion setting can be communicated to a user, e.g., a clinician, or to a controller device such as the controller circuit 214 for performing a desired action.

[0098] In some embodiments, the input interface 712 may be a direct data link between the CDSS 710 and one or more feature generating devices 730 that generate at least some of the input features. For example, the input interface 712 may transmit the input features directly to the CDSS 710 during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 712 may be a classical user interface that facilitates interaction between a user and the CDSS 710. For example, the input interface 712 may facilitate a user interface through which the user may manually enter at least some of the input features. Additionally, or alternatively, the input interface 712 may provide the CDSS 710 with access to a database of electronic patient record 720 from which one or more input features may be extracted. In any of these cases, the input interface 712 is configured to collect one or more of the image or video frames or features in association with a specific patient on or before a time at which the CDSS 710 is used to determine a proper laser retropulsion setting.

[0099] The controller circuit 214 may perform an inference operation using the ML model 714 to generate a proper laser retropulsion setting. For example, input interface 712 may deliver the one or more input features into an input layer of the ML model 714 which propagates these input features throughClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 the ML model 714 to an output layer. The ML model 714 can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The ML model 714 explores the study and construction of algorithms (e.g., machine-learning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an ML model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments, such as determining or adjusting the laser retropulsion setting 216, as stated above.

[0100] The trained ML model is able to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The ML model explores the study and construction of algorithms (e.g., ML algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building the ML model from training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0101] The ML model may be trained using supervised learning or unsupervised learning. Supervised learning uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised learning is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised learning is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised learning is useful in exploratory analysis because it can automatically identify structure in data.

[0102] Common tasks for supervised learning are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values. Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, RandomClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM). Examples of DNN include a convolutional neural network (CNN), a recurrent neural network (RNN), a deep belief network (DBN), or a hybrid neural network comprising two or more neural network models of different types or different model configurations. Some common tasks for unsupervised learning include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised learning algorithms are K-means clustering, principal component analysis, and autoencoders.

[0103] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0104] The training of the ML model may be performed continuously or periodically, or in near real time as additional procedure data are made available. The training process involves algorithmically adjusting one or more ML model parameters (e.g., weights or bias at any particular layer of a neural network model), until the ML model being trained satisfies a specified training convergence criterion. By way of example and not limitation, the ML model may be trained with weighted square loss (for explicit feedback) or with binary cross-entropy loss (for implicit feedback). Other training techniques, such as deep factorization machine, wide and deep learning, deep structured semantic models, or autoencoder based recommender systems, may be used. Then, during the inference operation, the patient specific input features provided to the ML model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the laser retropulsion setting. During and / or subsequent to the inference operation, the laserClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 retropulsion setting may be communicated to the user via the user interface (UI) and / or automatically cause the controller circuit 214 for performing a desired action.

[0105] FIG.8 is a flow chart illustrating an example method 800 for operating a surgical laser system with a controlled retropulsion setting to manipulate and ablate a calculi structure in an anatomical environment. The method 800 enables a feedback-controlled dynamic adjustment of laser retropulsion setting based on location, type, composition, or other characteristics of the target structure identified during the procedure. In some examples, the dynamic adjustment of the laser retropulsion setting 216 may be performed continuously or intermittently (e.g., at specified times) during the procedure.

[0106] The method 800 may be implemented in and executed by a laser energy delivery system, such as the laser energy delivery system 100 or a variant thereof, such as the surgical laser system 200 or the endoscopic laser lithotripsy system 300. Although the processes of the method 800 are drawn in one flow chart, they are not required to be performed in a particular order. In various examples, some of the processes may be performed in a different order than that illustrated herein.

[0107] At step 810, a laser fiber may be endoscopically placed to the calculi structure in the anatomical environment, such as a renal calculi structure in a patient’s renal system (e.g., the kidney or the ureter) during a laser lithotripsy procedure. At step 820, the calculi structure may be localized in the anatomical environment. In an example, an imaging sensor (such as the imaging sensor 224 or the camera or imaging device 325) may produce an image or video stream of the calculi structure in the anatomical environment. The image or video stream may be analyzed to determine the location of the calculi structure. In an example, renal calculi structure (renal stones) may be localized at major or minor calyx, renal pelvis, or a portion of the ureter, as illustrated in FIG.4.

[0108] At step 830, a decision is made such as by the controller circuit 214 or the controller circuit 314 whether the calculi structure is located at a target location. A target location, also referred to as a “convenient” location, may be a tight space or a “dead end” that securely entraps and stabilizes the calculi target or fragments thereof, such that laser treatment of the calculiClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 structure at the target location would not or less likely to cause further free motion or migration to other renal locations. As described above with respect to FIG.4, major or minor calyx are generally considered target or convenient locations, while other locations such as renal pelvis and ureter are generally considered inconvenient locations because ablation laser pulses would more likely cause the calculi structure therein to move and migrate to other renal locations.

[0109] If at step 830 it is determined that the calculi structure is not at the target convenient location, then at step 840, the laser system may operate under a first laser retropulsion setting (also referred to as high retropulsion setting) to emit first laser pulses. The first laser pulses, when incident on the target structure, have a high retropulsion effect to mobilize and push the calculi structure to the target convenient location, such as the major or minor calyx.

[0110] Various embodiments of the first laser pulses with a high retropulsion effect and the second laser pulses with a low retropulsion effect (relative to the fist laser pulses) are described with respect to FIGS.2 and 3. In an example, the laser system may include a Ho:YAG laser source to produce the first laser pulses with a high retropulsion effect, and a thulium laser source to produce the second laser pulses with a lower retropulsion effect but a higher target ablation efficiency than the Ho:YAG laser source.

[0111] In another example, one thulium laser source with a configurable or adjustable laser retropulsion setting may be used to provide first thulium laser pulses having a high retropulsion effect, and second thulium laser pulses having a low retropulsion effect. The high retropulsion setting can be configured by programming a specific pulse waveform of thulium laser, such as a rectangular laser pulse waveform with a specific pulse amplitude as shown in FIG.5A, or a descending triangle laser pulse waveform with a specific descending rate or pulse duration as shown in FIG.5B.

[0112] In some examples, the high retropulsion setting may include a pulse train with specific characteristics or patterns, such as specific pulse intensity and / or pulse width, such as those shown in FIGS.6A-6B. Such pulse train, when incident on the calculi structure, may promote formation of vapor bubbles at a vicinity of the calculi structure. The formation of vapor bubbles mayClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 enhance the high retropulsion effect on the target structure, and mobilize and cause migration of the calculi structure.

[0113] In some examples, the laser-generated high retropulsion effect may be enhanced by controlled collapse of vapor bubbles. In the presence of the vapor bubbles such as created by laser pulse trains shown in FIGS 6A-6B, laser emission may be temporarily suspended, or one or more of the pulse amplitude or the pulse width of the laser pulse train may be adjusted, to facilitate collapse of the vapor bubbles at a distance away from the target structure. The collapse of vapor bubbles may produce a propulsion force against a surface of the target structure, which may mobilize and push the target structure away from its current location to a desired convenient location.

[0114] In some examples, the laser-generated high retropulsion effect may be enhanced by controlled withdrawal (e.g., robotic withdrawal via the actuator 338) of the laser fiber from the target structure while delivering laser pulses under high retropulsion effect (such as the laser pulses with the unique waveforms and parameters as shown in FIGS.5A-5B, or pulse trains as illustrated in FIGS.6A-6B). As the laser fiber moves backward, fluid filling the space may be vaporized to create large bubbles. Depending on how quickly the laser fiber is withdrawn, a cavitation effect may be created that may result in a significantly larger vapor bubble due to the water vapor contained in that low pressure cavitation bubble at the distal end of the laser fiber may be instantly heated at high temperature by the laser pulses.

[0115] If at step 830 it is determined that the calculi structure is located at the target location, or if the calculi structure has migrated to the target location due to the retropulsion force produced by the first laser pulses at step 840, then at step 850, the laser system may be adjusted (such as by the controller circuit 214 or the controller circuit 314) to operate under a second laser retropulsion setting (also referred to as low retropulsion setting) to emit second laser pulses. The second laser pulses, when incident on the target structure, have a second retropulsion effect lower than the first retropulsion effect, but a higher efficiency than the first laser pulses to ablate or fragment the calculi structure at the target convenient location.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0116] In some examples, a proper laser retropulsion setting at any stage of the procedure may be determined or selected using artificial intelligence (AI) or machine learning (ML) based techniques. For example, image or video frames of the target structure or features extracted therefrom may be applied to a trained ML model to automatically recognize location, type, composition, or other characteristics of the target structure identified during the procedure. The recognized characteristics may be used to determine or adjust the laser retropulsion setting. In some examples, the image or video frames of the target structure and / or the feedback information such as location, type, composition, or other characteristics of the target structure may be applied to a trained ML model to directly determine a proper laser retropulsion setting. Examples of the ML model used for recognizing anomaly from endoscopic images or video streams include Convolutional Neural Networks, bi-directional LSTM, Recurrent Neural Networks, Conditional Random Fields, Dictionary Learning, or other machine learning techniques (support vector machine, Bayesian models, decision trees, k- means clustering), among other ML techniques. The trained ML model may be stored in a storage device.

[0117] In some examples, at step 850, a laser output setting, including one or more irradiation parameters, may be adjusted based on information about target identification, such as target type (e.g., tissue or calculi structure) or target composition. The target identification may be performed by the feedback analyzer 212 of FIG.2, or the feedback analyzer 312 of FIG.3. The target identification information may also be used to guide adjustment of the position or orientation of the distal end of the laser fiber.

[0118] FIG.9 illustrates generally a block diagram of an example machine 900 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Portions of this description may apply to the computing framework of various portions of the laser energy delivery system 100 (e.g., the laser feedback control system 101), the surgical laser system 200, or the endoscopic laser lithotripsy system 300.

[0119] In alternative embodiments, the machine 900 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 900 may operate in the capacity of a serverClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 machine, a client machine, or both in server-client network environments. In an example, the machine 900 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 900 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0120] Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms. Circuit sets are a collection of circuits implemented in tangible entities that include hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership may be flexible over time and underlying hardware variability. Circuit sets include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuit set in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuit set member when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuit set. For example, under operation,Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 execution units may be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.

[0121] Machine (e.g., computer system) 900 may include a hardware processor 902 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 904 and a static memory 906, some or all of which may communicate with each other via an interlink (e.g., bus) 908. The machine 900 may further include a display unit 910 (e.g., a raster display, vector display, holographic display, etc.), an alphanumeric input device 912 (e.g., a keyboard), and a user interface (UI) navigation device 914 (e.g., a mouse). In an example, the display unit 910, input device 912 and UI navigation device 914 may be a touch screen display. The machine 900 may additionally include a storage device (e.g., drive unit) 916, a signal generation device 918 (e.g., a speaker), a network interface device 920, and one or more sensors 921, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensors. The machine 900 may include an output controller 928, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0122] The storage device 916 may include a machine readable medium 922 on which is stored one or more sets of data structures or instructions 924 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 924 may also reside, completely or at least partially, within the main memory 904, within static memory 906, or within the hardware processor 902 during execution thereof by the machine 900. In an example, one or any combination of the hardware processor 902, the main memory 904, the static memory 906, or the storage device 916 may constitute machine readable media.

[0123] While the machine-readable medium 922 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 924.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1

[0124] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 900 and that cause the machine 900 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non- limiting machine-readable medium examples may include solid-state memories, and optical and magnetic media. In an example, a massed machine-readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine- readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EPSOM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0125] The instructions 924 may further be transmitted or received over a communication network 926 using a transmission medium via the network interface device 920 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 920 may include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to the communication network 926. In an example, the network interface device 920 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to includeClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 900, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. Additional Notes

[0126] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0127] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0128] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can beClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 What is claimed is:

1. An surgical laser system, comprising: a laser system configured to provide laser pulses to a calculi structure in an anatomical environment of a patient via a laser fiber according to an adjustable laser output setting; and a controller circuit configured to: localize the calculi structure in the anatomical environment; if the calculi structure is at a location other than a target location, generate a control signal to the laser system to emit first laser pulses according to a first laser output setting, the first laser pulses having a first retropulsion effect to mobilize and reposition the calculi structure to the target location; and generate a control signal to the laser system to emit second laser pulses according to a second laser output setting to ablate or fragment the calculi structure at the target location, the second laser pulses having a second retropulsion effect lower than the first retropulsion effect.

2. The surgical laser system of claim 1, wherein the calculi structure includes a renal calculi structure, wherein the target location includes a major or minor calyx of a kidney.

3. The surgical laser system of any of claims 1-2, comprising an imaging sensor configure to provide an image or video stream of the calculi structure in the anatomical environment, wherein the controller circuit configured to localize the calculi structure using the image or video stream of the calculi structure.

4. The surgical laser system of any of claims 1-3, wherein the laser system includes: a Holmium:Yttrium-Aluminium-Garnet (Ho:YAG) laser source configured to emit the first laser pulses having the first retropulsion effect; and a thulium laser source configured to emit the second laser pulses having the second retropulsion effect.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 5. The surgical laser system of any of claims 1-4, wherein the laser system includes a thulium laser source configured to generate thulium laser pulses in accordance with an adjustable laser output setting, including first thulium laser pulses having the first retropulsion effect and second laser thulium pulses having the second retropulsion effect.

6. The surgical laser system of claim 5, wherein the first laser output setting includes a rectangular laser pulse waveform with a specific pulse amplitude.

7. The surgical laser system of claim 5, wherein the first laser output setting includes a descending triangle laser pulse waveform with a specific descending rate or pulse duration.

8. The surgical laser system of any of claims 1-7, wherein the first laser pulses include a train of laser pulses with an adjustable pulse amplitude or an adjustable pulse width.

9. The surgical laser system of claim 8, wherein the controller circuit is configured to adjust one or more of a pulse amplitude or a pulse width such that the train of laser pulses incident on the calculi structure produces vapor bubbles at a vicinity of the calculi structure that mobilize and cause migration of the calculi structure.

10. The surgical laser system of claim 9, wherein the controller circuit is configured to, in a presence of the vapor bubbles, temporarily withhold emission or adjust one or more of the pulse amplitude or the pulse width of the first laser pulses to facilitate collapse of the vapor bubbles at a distance away from the calculi structure, , the collapse of the vapor bubbles producing a propulsion force against a surface of the calculi structure.Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 11. The surgical laser system of any of claims 1-10, wherein the controller circuit is configured to generate a control signal to an actuator to robotically adjust at least a distal portion of the laser fiber.

12. The surgical laser system of claim 11, wherein to robotically adjust at least the distal portion of the laser fiber includes to withdraw the distal portion of the laser fiber away from the calculi structure to create a space in between that facilitates formation of vapor bubbles in response to the first laser pulses incident on the calculi structure according to the first laser output setting.

13. A method of operating a surgical laser system to ablate or fragment a calculi structure in an anatomical environment of a patient via a laser system, the method comprising: endoscopically placing a laser fiber to the calculi structure in the anatomical environment; localizing the calculi structure in the anatomical environment; when the calculi structure is at a location other than a target location, controllably adjusting the laser system to emit first laser pulses according to a first laser output setting, the first laser pulses having a first retropulsion effect to mobilize and reposition the calculi structure to the target location; and when the calculi structure is located at the target location, controllably adjusting the laser system to emit second laser pulses according to a second laser output setting to ablate or fragment the calculi structure at the target location, the second laser pulses having a second retropulsion effect lower than the first retropulsion effect.

14. The method of claim 13, wherein the calculi structure includes a renal calculi structure, wherein the target location includes a major or minor calyx of a kidney.

15. The method of any of claims 13-14, comprising generating an image or video stream of the calculi structure in the anatomical environment using an imaging sensor,Client Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 wherein localizing the calculi structure includes using the image or video stream of the calculi structure.

16. The method of any of claims 13-15, wherein controllably adjusting the laser system to emit first laser pulses includes activating a Holmium:Yttrium-Aluminium-Garnet (Ho:YAG) laser source to emit the first laser pulses having the first retropulsion effect, wherein controllably adjusting the laser system to emit second laser pulses incudes activating a thulium laser source to emit the second laser pulses having the second retropulsion effect lower than the first retropulsion effect.

17. The method of any of claims 13-16, wherein controllably adjusting the laser system to emit first laser pulses includes activating a thulium laser source to emit first thulium laser pulses having the first retropulsion effect, wherein controllably adjusting the laser system to emit second laser pulses incudes activating the thulium laser source to emit second laser thulium pulses having the second retropulsion effect lower than the first retropulsion effect.

18. The method of any of claims 13-17, wherein the first laser output setting includes a rectangular laser pulse waveform with a specific pulse amplitude.

19. The method of any of claims 13-17, wherein the first laser output setting includes a descending triangle laser pulse waveform with a specific descending rate or pulse duration.

20. The method of any of claims 13-19, wherein the first laser pulses include a train of laser pulses with an adjustable pulse amplitude or an adjustable pulse width, the method further comprising adjusting one or more of a pulse amplitude or a pulse width such that the train of laser pulses incident on theClient Ref. No. GAP24009-URKT-WO1 Docket No.5409.869WO1 calculi structure produces vapor bubbles at a vicinity of the calculi structure that mobilize and cause migration of the calculi structure.

21. The method of claim 20, further comprising, in a presence of the vapor bubbles, temporarily withholding emission or adjusting one or more of the pulse amplitude or the pulse width of the first laser pulses to facilitate collapse of the vapor bubbles at a distance away from the calculi structure, the collapse of the vapor bubbles producing a propulsion force against a surface of the calculi structure.

22. The method of any of claims 13-21, further comprising generating a control signal to an actuator to robotically withdraw at least a distal portion of the laser fiber away from the calculi structure to create a space in between that facilitates formation of vapor bubbles in response to the first laser pulses incident on the calculi structure according to the first laser output setting.

Images