System for urological stone treatment and method of use

Abstract

This invention provides a novel medical device for performing precise urological procedures, specifically focusing on urological stone removal. The illustrative Stone Removal Robot leverages multiple subsystems to autonomously remove stones while using real-time image guidance for precise targeting and minimal collateral damage. This system is particularly suited for use in urology, though its applications can extend to other surgical fields. The key benefit of this invention lies in its ability to provide enhanced accuracy, reducing the potential for human error, while integrating multiple lithotripsy methods termed herein, Method1, Method2, Method3, which may incorporate cooling to protect surrounding tissues. The system can be adapted for autonomous operation.

Description

Docket No.: 578 / 0002PCTSYSTEM FOR UROLOGICAL STONE TREATMENT AND METHOD OF USERELATED APPLICATIONS

[0001] This application claims the benefit of co-pending U.S. Provisional Application Serial No. 63 / 689,757, entitled A UROLOGICAL STONE TREATMENT SYSTEM, filed 9 / 1 / 2024. and co-pending U.S. Provisional Application No. 63 / 742.784, entitled TREATMENT SYSTEM TO AUTOMATICALLY CUT AND COAGULATE TISSUE AND METHOD FOR USE, filed 1 / 7 / 2025, the teachings of each of which applications are expressly incorporated herein by reference.FIELD OF THE INVENTION

[0002] This invention relates to automated surgical and medical treatment systems and methods, and more particularly to systems used in urology.BACKGROUND OF THE INVENTION

[0003] The use of robotic surgical systems and devices has been increasing in popularity over recent years. Such systems can employ visual, tactile and other forms of sensors, as well as (e.g.) video, ultrasound, X-ray, CT, MRI, etc. imaging to navigate the patient’s anatomy. In the case of visual imaging (in visible or near-visible wavelengths), the robotic manipulator can be servoed based upon pattern recognition applications. The applications can employ traditional machine vision algorithms and or deep learning / Al neural networks.

[0004] Robotic manipulators can perform a variety of surgical tasks using appropriate tools provided upon an end effector (i.e. at the distal end of the manipulator). One area in which robotic surger ' is desirable is urologic applications, and more particularly in the area of the treatment and removal of calculus deposits composed ty pically of phosphates and urates, and also termed “stones”. In such treatments, speed and accuracy are significant concerns, thus making automation desirable.SUMMARY OF THE INVENTION

[0005] This invention addresses limitations in prior art by providing a novel medical device for performing precise urological procedures, specifically focusing on urological stone stone removal. The illustrative Stone Removal Robot leverages multiple subsystems to autonomously remove stones while using real-time image guidance for precise targeting andDocket No.: 578 / 0002PCT minimal collateral damage. This system is particularly suited for use in urology, though its applications can extend to other surgical fields. The key benefit of this invention lies in its ability to provide enhanced accuracy, reducing the potential for human error, while integrating multiple lithotripsy methods termed herein. Methodi, Method2, Methods, which employ various types and combinations of energy (radio frequency (RF), ultrasound, laser, etc., and which can incorporate cooling to protect surrounding tissues.

[0006] Unlike prior systems that either require manual operation or are limited to individual functions (e g., lithotripsy without removal), this invention offers a fully integrated approach. By combining autonomous operation with advanced imaging technology7, the robot ensures that surgeons can perform complex procedures with greater precision and efficiency. The robot's ability to adjust energy output for stone resection and pulverization, which may include targeted cooling, makes it a valuable tool for minimizing tissue damage in sensitive surgical areas. The cooling function is essential to protect healthy tissues from thermal damage, an issue commonly encountered with high-energy surgical tools.

[0007] In an exemplary7embodiment, the system is composed of three main subsystems: the System Control Unit, the Delivery7Unit, and the System Console. These components work in tandem to achieve real-time, image-guided stone removal treatment, with feedback mechanisms ensuring accuracy and safety throughout the procedure. The system provides automated control of lithotripsy energy7delivery, minimizing the surgeon’s manual intervention and enabling a more streamlined workflow. Additionally, the system's treatment net probe preserv es the integrity of stone fragments, making the system safe.

[0008] In an illustrative embodiment, a system for autonomous urologic stone removal from a region of a patient includes an imaging transducer that images the region in real time, and a processor receives the images and recognizes features therein related to the region. A robotic treatment probe is constructed an arranged to be robotically inserted into and perform removal of the urological stone at the region based upon instructions from the processor, and an active cooling circuit circulates predetermined volumes of fluid at the region. Illustratively, an aspiration circuit directs fluid from the region to a remote location for collection. The aspiration circuit can capture fluid and enable volumetric analysis. The aspiration circuit can further include a filter that captures particulates for analysis. Illustratively, the region is the peritoneal region. A graphical user interface can beDocket No.: 578 / 0002PCT constructed and arranged to enable planning of a path of the surgery' and treatment probe based upon real-time images overlaid on prior-acquired images from a scanning modality. The imaging transducer can comprise an ultrasound transducer that provides images to a user, user.

[0009] In an illustrative embodiment, a method for urological surgery', generally for treatment / removal of urologic stones, can employ the above-described system to perform steps of: preparing the surgical site and locating the imaging transducer and treatment probe with respect to the region; locating a lithotripsy position, beginning imaging with the imaging transducer; inserting the treatment probe and adjusting a sonogram from the imaging transducer using a user interface; positioning the treatment probe at a home position, developing a treatment plan on the user interface and irrigating the region; and performing treatment of the region, including initiation, grasping of the stone with a finger assembly on the treatment probe, aspiration, hemostasis, based upon motion control of the treatment probe based upon the processor. Illustratively, treatment reports are provided to a user, filtered aspirate from the region is processed, and waste is disposed. One or more of three discrete lithotripsy techniques / methods that deliver energy to the stone to reduce the size thereof. Can be performed, including, application of RF energy', ultrasound energy' and laser energy. The lithotripsy techniques can be monitored for energy delivery, and energy delivery and / or cooling can be controlled based upon the monitoring. A graphical user interface for planning of a path of the treatment probe can be operated based upon real-time images overlaid on prior-acquired images from a scanning modality'. The images can be derived from at least one of ultrasound, X-ray, CT and MRI scans. Illustratively, the imaging transducer is an ultrasound probe, but other types of imaging — e.g. fluoroscopy can be employed in alternate implementations. The processor can be adapted to operate the treatment probe autonomously. The processor can employ a 3D treatment plan that maps a treatment region of the patient, and follows program steps to perform the method.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The invention description below refers to the accompanying drawings, of which:

[0011] Fig. 1 is a diagram showing an overall system for conducting robotically guided surgery' for (e.g.) urologic stone-removal / treatment procedures according to an illustrative embodiment;Docket No.: 578 / 0002PCT

[0012] Fig. 2 is a block diagram showing functional components of the system of Fig. 1, including three primary components thereof;

[0013] Fig. 3 is a diagram showing an exemplary GUI display of the treatment path / plan in the arrangement of Fig. 1;

[0014] Fig. 4 is a flow diagram showing an overall operational procedure for the system and method according to the arrangement of Fig. 1;

[0015] Fig. 5 is a flow diagram showing the preparation steps in the overall procedure of Fig. 4;

[0016] Fig. 6 is a flow diagram showing the insertion and alignment steps in the overall procedure of Fig. 4;

[0017] Fig. 7 is a flow diagram showing the position and planning steps in the overall procedure of Fig. 4;

[0018] Fig. 8 is a flow diagram showing the treatment steps in the overall procedure of Fig. 4; and

[0019] Fig. 9 is a flow diagram of the post-treatment, cleanup steps in the overall procedure of Fig. 4.DETAILED DESCRIPTION

[0020] I. System Overview

[0021] Reference is made to Fig. 1, which depicts an overall arrangement 100 of the system and method for urological stone treatment and removal in a patient(patient’ s / subj ecfs) body 112. This system and method provides a rapid and efficient surgical intervention that is obtainable in image-guided approaches according to the embodiments herein. The arrangement 100 shows the treatment net probe 114 adapted to be inserted into peritoneal area 113 of the body 112 in position relative to the a commercially available, (e.g.) third party ultrasound transducer device 115 while the user (a medical practitioner 119) observes and guides the procedure on the display monitor 116. As shown, such techniques can allow for a total planning and treatment time in the range of (e g.) 20-30 minutes, when successful. According to the novel system and method herein, the traditional surgical modalities, and associated results, can be substituted with those of this system and method. According to the novel system and method herein, the traditional surgical modalities, and associated results, can be substituted with autonomous stone removal. As described below, these robotic treatment arrangements employ 3D imaging sensors such asDocket No.: 578 / 0002PCT3D ultrasound that are typically inserted into the patient's body during the procedure. By way of a non-limiting example, following an autonomous pre-planned treatment path can effectively reduce the kidney stone removal time to less than 15 minutes.

[0022] Overall, the system and method provides autonomous treatment according to an Al-assisted image-guided treatment plan, which advantageously increases the probability of successfully completing treatments rapidly, which likewise helps to avoid excessive bleeding, infection risk, urinary incontinence, and / or sexual side effects which may otherwise be encountered with other treatment arrangements.

[0023] It is noted that the components provided herein can be similar in structure and function to commonly assigned PCT Application Serial No. xxx / xxxxx, entitled TREATMENT SYSTEM TO AUTOMATICALLY CUT AND COAGULATE TISSUE, filed 09 / 01 / 2025, the teachings of which are expressly incorporated herein by reference.

[0024] I. Application in Urological Procedures

[0025] The system is adapted for use in urological surgeries, where precision is critical for procedures such as stone resection and removal, or surgical treatment of other urological conditions. Traditional surgical tools may lack the precision required to target small, delicate areas in the urinary tract, but this invention addresses that limitation by providing accurate, real-time imaging and precise control over stone resection and removal. The autonomous nature of the system reduces the reliance on manual intervention, thereby improving outcomes and reducing recovery times for patients.

[0026] A. Autonomous Operation and Image Guidance

[0027] The system's autonomous operation is a major advancement over prior technology. Through the use of real-time 3D imaging shown by the System Console 202 (Fig. 2, described further below), the system can autonomously move to the targeted treatment area and perform stone removal with minimal input from the surgeon. The user interface allows the surgeon to visualize the treatment area from multiple perspectives, offering full control over the procedure while benefiting from the system's automated functionality. This combination of automation and image guidance significantly reduces the margin of error, enhancing both safety and efficacy.

[0028] B. Benefits Over Existing Technology

[0029] Existing urological treatment systems often rely on separate tools for stone breakup and stone removal, and these tools generally require manual operation. ThisDocket No.: 578 / 0002PCT invention overcomes the disadvantages of traditional systems by integrating all stone removal removal functions into a single robotic device. Furthermore, the real-time image guidance system allows for greater precision and control, reducing the likelihood of damage to surrounding tissues. The system also offers a modular design, enabling it to be adapted for various urological and non-urological procedures, increasing its versatility and range of applications.

[0030] C. Subsystems Employed by the System and Method

[0031] 1. System Control Unit

[0032] Reference is made to the diagram showing the system 200 of Fig. 2, where the System Control Unit 219 serves as the core control hub of the system, managing the energy output for multiple individual or simultaneous resection and lithotripsy energy delivery methods 12A (Methodi), 12B (Method2), and / or 12C (Methods) via the treatment probe. These delivery methods, each use one or more types of energy to break up stones. They can be employed in manners clear to those of skill. By way on non-limiting example, the energy types can include radio frequency (RF), ultrasound, laser, and other ty pes of energy, typically electrically generated, that cause sufficient vibration in a stone to fragment it into smaller, extractable components. It monitors the status of the Delivery Unit 225 and sends real-time commands to adjust energy levels based on feedback from the System Console 202.

[0033] 2. Centralized Control

[0034] The Control Unit Operation Control 211 implements microprocessor or microcontroller based management of System Control Unit functions, ensuring that all components work in harmony, providing seamless integration between the stone removal and cooling processes. The Control Unit Operation Control 21 1 utilizes a real-time operating system to constantly monitor the status of the procedure, making real-time adjustments to energy output and cooling levels as needed.

[0035] Interfaces to other subsystems are managed by dedicated hardware included in the System Control Unit 219. For example, the System Control Unit to System Console Communication 210 is typically a type of serial port or UART connection communicating UI information. Interface to the Fragment Retrieval / Aspiration Pump 219 and Cooling Pump 222 is provided by the Fragment Retrieval / Aspiration Pump Motor Control 212 and Cooling Pump Control 215, respectively.Docket No.: 578 / 0002PCT

[0036] The user can initiate on / off control of treatment using the Foot Pedal 223 interfaced through the Foot Pedal Control 216, and can view brief alphanumeric 1 or 2 line status information via the Main Treatment / Control Unit Indicator 224, connected through Main Treatment / Control Unit Indicator Control 217. Such controls and indicators are commercially available and commonly utilized in medical equipment.

[0037] The stone removal processes are managed through separate interfaces to convey commands and feedback to and from the Treatment Delivery Unit 225 to ensure precise temperature control, so that stones can be removed without causing excessive damage to surrounding areas. This feature allows for safe, efficient stone breakup while reducing the risk of unintended injury to adjacent tissues.

[0038] One of the stone removal energy interfaces is the control, which provides the energy Multi-Method Lithotripsy Output 220 to the Treatment Delivery Unit 225. Another is the Cooling Control 214, which regulates the variable amount of liquid cooling supplied to the Delivery Unit 225 by management of the Cooling Generator Output 221. Cooling can be implemented by one of many conventional methods, including thermoelectric, compressor refrigeration, etc. Finally, the Control Unit to Delivery Unit Interface 218 is typically a type of serial port or UART connection 218A communicating command and control information between subsystems.

[0039] D. Delivery Unit

[0040] The Delivery Unit 225 is responsible for delivering the stone removal and cooling outputs to the treatment area. This subsy stem is designed for autonomous operation, enabling it to accurately target and treat stones based on commands from the System Control Unit 219, returning feedback on treatment progress.

[0041] Overall functioning of the Delivery' Control Unit 225 is managed by the Treatment Delivery’ Unit Operation Control 231, which implements microprocessor or microcontroller based management of Treatment Delivery Control Unit functions.

[0042] Interface to the System Control Unit 219 is furnished by’ the Delivery Unit to System Control Unit Communication 230 typically implemented using a type of serial port or UART connection communicating command and control information between subsystems.

[0043] The other two interfaces to the System Control Unit 219 are earned out through Temperature Control hardware 226 and Cooling Interface 227.Docket No.: 578 / 0002PCT

[0044] To provide accurate motion control of the Treatment Probe(s) 239 for both position and velocity, the Delivery Unit 225 is equipped with probe motion Distance Measurement 228 and Rotation Measurement 229. The interface to the probe movement function is multi-axis Motor Control 232, which drives / monitors the Probe Vertical Movement Motor 235, Probe Rotation Movement Motor 236 and Probe Horizontal Movement Motor 237. The electrical interface to the Treatment Probe 239 is routed through the Treatment Probe Interface 234.

[0045] As depicted, another stone removal interface is the Finger Control 1 IX, which provides motion control of the treatment net probe fingers and deployment of the capture sheath 1 IE through Sheath Deployment Output Control 12Y of the Delivery Unit 125. The interface to the treatment probe net fingers is through Finger Control 1 IX and Sheath Deployment Output Control 12Y which drive / monitor the Probe Finger Movement Motor 13B and Probe Sheath Deployment Motor 13C to extend the capture sheath with its expandable netting over the entire surface of the probe fingers, while minimizing any gap at the distal tip where the fingers come together.

[0046] Finally, the user / practitioner can interact with certain treatment parameters utilizing the Delivery Unit Keypad 238 interfaced through the Delivery Unit Keypad Control 233.

[0047] 1. Tissue Protection with Cooling Mechanism

[0048] A significant innovation of the Treatment Delivery' Unit 225 is the inclusion of a cooling mechanism, which is activated to protect surrounding tissues from thermal damage. The cooling mechanism is fully integrated into the system's treatment delivery, ensuring that the maximum temperature of the treated area is carefully managed throughout the procedure.

[0049] 2. Autonomous Movement and Targeting

[0050] Through the use of advanced motion control, the Delivery Unit 225 can autonomously position itself in the treatment area and deliver energy with pinpoint accuracy. This autonomous capability' reduces the surgeon's workload and enhances the overall precision of the procedure. Such positioning is attained, e.g. using visual feedback from images and pattern recognition processes that assist in servoing the moving components of the device, and corresponding mechanisms (e.g. cutting, gripping, cooling, vacuum, etc.) at appropriate times based upon programmed steps. Such programming can be implementedDocket No.: 578 / 0002PCT using existing image recognition and robotic control software, adapted using skill in the art to to perform the desired autonomous functions.

[0051] 3. Stone Resection and Lithotripsy

[0052] The Stone Treatment Net Probe (gripping) Fingers 1 ID can be expanded out when the probe is positioned near the stone area. It can then grab the outside of each of the stone(s), and then deliver the initial treatment modality, e.g. energy applied through the fingers to separate a stone that adheres to tissue. With the stone separated, the fingers 1 ID are all closed around the stone, and a capture sheath 1 IE can be deployed to cover the outside of the fingers 1 ID. When the capture sheath 1 IE has completely covered the fingers 1 ID and the stone(s) trapped inside, the next step of treatment can deliver (e g. ultrasound) energy' to pulverize the stone, with simultaneous suctioning of stone fragments.

[0053] The energy output for stone breakup can be modulated by the software in the Delivery Unit Operation Control 131 using one or more illustrative lithotripsy methods 12A (Methodi). 12B (Method2), and / or 12C (Method3), applied either individually, or simultaneously, based on the specific needs of the procedure. This ensures that the right amount of energy' is delivered to the stone, minimizing the risk of overtreatment or undertreatment.

[0054] 4. Intake / Output Monitoring and Control

[0055] Pumping control of irrigation and aspiration results in volumetric intake / output reporting of total captured Aspiration Liquid (volume, blood%, etc.), available on the display of the Delivery Unit Keypad 238. Optionally, aspirated particulate from stones can be captured by filter elements of the disposable aspiration set for later laboratory analysis. As such, reference is made to Fig. 1 and the Aspiration Filter Element 108 removably installed on the cart 110.

[0056] E. System Console

[0057] The System Console (Imaging Guidance) 202 plays a critical role in the system by providing a Graphical User Interface (GUI) to real-time, 3D imaging of the treatment area. This subsystem allows the surgeon to visualize the targeted stones from multiple perspectives, enabling precise control over the procedure.

[0058] The necessary' software subsystems can be implemented on commercially available desktop PC hardware, for example those employing AMD64 microprocessor architecture, video capture hardware, and Microsoft Windows operating system. SuchDocket No.: 578 / 0002PCT software subsystems include a Software Service Layer 203 to communicate via industry - standard interfaces, such as Ethernet and DVI, to the operating console of a commercially available 3rd Party Ultrasound Device 201. The Software Applicator Layer 204 utilizes the services provided by the previous layer and provides the GUI display and control elements to the Software Presentation Layer 205. An Internet Connection 208 is provided for stored medical image retrieval from previous diagnostic procedures, as well as archiving, billing, and software update purposes.

[0059] 1. Acquisition of 3D Images

[0060] The system acquires 3D images from the operating console of the 3rd Party7Ultrasound Device 201 from multiple angles, which are displayed on the Display Monitor 207, which the user controls through the Keyboard 206 (and / or other data manipulation device, such as a touchscreen, trackball, mouse, etc.). The keyboard 206 can also be used to enter patient demographic information, and other documentation for the treatment procedure. Displaying 2D views of these 3D images allows the surgeon to plan and execute the procedure with enhanced accuracy, making it easier to navigate complex anatomical structures.

[0061] 2. Integration with the Main Control Station

[0062] The System Console 202 is fully integrated with the System Control Unit by a bidirectional communication interface, allowing for real-time adjustments based on feedback from the imaging system, typically through a serial port or UART connection 218B. This integration ensures that the treatment delivery is precisely aligned w ith the imaging data, further enhancing the accuracy of the procedure.

[0063] III. Treatment Techniques and Results

[0064] A. Overall Arrangement

[0065] The system and method employs a pre-planned autonomous treatment, to select the best surgical approach among several parameters before treatment starts, allowing for thorough preparation and consideration of various factors such as anatomic variation and extent of disease. In contrast, real-time manual surgical guidance offers the flexibility to adjust treatment paths based on immediate imaging feedback, and other real-time factors, ensuring a dynamic and adaptive treatment. This method can be invaluable when a highly- skilled operator deals with unexpected obstacles or when precise timing is crucial, as it can provide increased efficiency if surgical conditions rapidly change. Fortunately, the visibilityDocket No.: 578 / 0002PCT of critical structures through 3D real-time imaging provides a stable basis for autonomous treatment, reducing dependence upon operator skill and experience. The key difference lies in in the balance between adaptability and preparedness; real-time treatment maximizes flexibility and emphasizes operator skill and experience, while pre-planned autonomous treatment emphasizes foresight and control.

[0066] Reference is again made to Fig. 1, which shows an overall representation 100 of the system and method in a patient's (subject's) body 102. These data demonstrate that more rapid and repeatable surgical treatment of urological conditions that is obtainable with fewer side effects using the autonomous, image-guided approaches according to the embodiments herein.

[0067] The diagram / representation in Fig. 1 shows the location relative to the patient’s peritoneal area 103 of the treatment net probe 104 and the imaging transducer 105. As shown, such techniques can allow for treatment in the range of 20-30 minutes, when successful. Overall, the system and method provides autonomous image-guided treatment which advantageously increases the probability of rapidly treating urological symptoms with a minimum of undesired side effects which may otherwise occur with other treatment modalities.

[0068] B. Alternative Energy’ Sources

[0069] By way of further background, previous innovations in urological surgical intervention have fallen into two broad categories, namely, (a) mechanical approaches, or (b) energy delivery approaches. In general, such schemes / approaches have failed to perform as intended and / or else have never been widely adopted for use in the field of urology. High energy ultrasound, waterjets, lasers and traditional radiofrequency ablation have failed to provide a modality whose surgical performance was acceptable without undesirable clinical side effects. The illustrative system and method herein utilizes various unique techniques of energy delivery with active cooling via autonomous motion control and machine learning. Hence, the system and method can effectively address a broad range of clinical applications by including various inexpensive, clinically and commercially validated off-the-shelf technologies, such as robotics and fluid management.

[0070] C. Enhanced Hemostasis and Recovery- Times

[0071] The system and method herein takes into account unwanted injury to adjacent blood vessels using (by way of non-limiting example) non-thermal electrical energy-. NoteDocket No.: 578 / 0002PCT that other techniques for improved hemostasis should be clear to those of skill, including, but not limited to applying active cooling, real-time limiting of electric field density, and / or various waveforms of applied electrical currents or acoustic energy. Moreover, a common challenge in applying machine-learning to autonomous treatment is a lack of attention given towards motion control improvements that can provide more robust accuracy and precision in in treatment guidance in the first place. It is contemplated that commercially available robotics technologies can be refined so that positional accuracy can be as high as possible. These challenges can include kinematic errors arising from inaccuracies in the mechanical structure, such as manufacturing tolerances and assembly errors, non-kinematic errors like temperature variations, joint compliance, and gear backlash which can significantly impact accuracy, environmental disturbances, calibration limitations, and differences in tools and materials used that can introduce inconsistencies in performance. These challenges involve inherently large patient-to-patient variations in anatomic positioning of internal organs and structures. Machine-learning techniques can be applied to address these sources of variability, variability, allowing relatively inexperienced users to navigate treatments quickly and efficiently. By way of non-limiting example, the user-defined stone capture profile path / plan310 (310 in Fig. 3) can be further modified / enhanced by machine learning, comprising ultrasound or other real time imaging feedback during a urological treatment.

[0072] Further reference is made to Fig. 3, the stone capture profile path / plan user interface (UI) 300, which shows two zones: a real-time endoscope image display window 307 and real-time ultrasound image display window. The real-time ultrasound image displaywindow 308 contains the current real-time ultrasound image 301 in the background. As an overlay, a stored image 303 of a previous diagnostic test, delivered via the internet, is presented to the user. By way of non-limiting example, this may be a CT or MRI image. Using appropriate drawing controls, the user-defined stone capture path 310 can be outlined by the user.

[0073] The real-time endoscope image display window 307 contains the current realtime image from the treatment net probe’s built-in endoscopic camera in the background. As an overlay, a stored image 305 from a previous diagnostic test, delivered via the internet, is presented to the user in the same perspective as the endoscopic image. By way of nonlimiting example, this image may be a CT or MRI image. The desired treatment plan outline 306 is presented as an additional overlay from the same perspective as the endoscopic image,Docket No.: 578 / 0002PCT based upon the user-defined stone capture path 310 shown on the real time ultrasound image display window 308.

[0074] In the real time ultrasound image display window 308. the user may switch between different two-dimensional (2D) representations of the three-dimensional (3D) ultrasound scan. The image from previous diagnostic test result image 303 will indicate the location of the desired treatment area. The user may use this image to identify the boundaries for the surgical treatment area, and to draw the desired stone capture path 20F. The system software can initially provide suggested boundaries for stone resection and capture which can be modified by the user if desired.

[0075] After positioning at the end of the desired stone capture path 310, the treatment net probe fingers 1 ID (Fig. 2) expand out when positioned near the stone area, to grab the outside of stones and then deliver the initial treatment modality, e.g. energy applied through the fingers 1 ID to separate a stone that adheres to tissue. With the stone separated, the fingers 1 ID (Fig. 2) are all closed around the stone, and a capture sheath 1 IE is deployed to cover the outside of the fingers 1 ID with a collapsable and expandable netting fine enough to capture the majority of stone fragments. When the capture sheath 1 IE has completely covered the fingers 1 ID and the stone(s) trapped inside, the next part of treatment will start to pulverize the stone, with simultaneous suctioning of stone fragments.

[0076] The system also offers a mobile application for use on a mobile device (110 in Fig. 1) to communicate with the console system. This mobile device 110 may be a cellular telephone, tablet computer, or other commercially available devices commonly used by medical users. Using the mobile device 110, the user may send the treatment plan outline to other users for consultation purposes. Any treatment plan outline changes suggested by the consulting user will be received through the internet connection (208 in Fig 2) and displayed in the desired stone capture path (310 in Fig. 3). The operating user may then confirm the final treatment plan outline on the real-time ultrasound image display window (308 in Fig. 3) prior to initiating stone resection and lithotripsy.

[0077] The real time endoscope image display window (307 in Fig. 3) is provided for display only and is not utilized for revising or confirming the stone capture profile. Note that 3D ultrasound is one of a variety of sensor types that can be employed to provide desired real-time spatial data. It should clear to those of skill that other types of 3D sensing devices can be employed herein.Docket No.: 578 / 0002PCT

[0078] It is recognized in implementing the system and method herein that accurate and precise positioning of treatment can significantly improve the quality of the anatomic features to be used for machine learning. Such preprocessing can potentially include the use of voxel-based imaging processing and analysis. In particular. Voxel-based Nearest Neighbor (VNN) can enhance the speed and accuracy of 3D reconstruction.

[0079] It is contemplated that the autonomous treatment techniques herein can further employ machine learning via, for example, 3D convolutional neural networks (CNNs). CNNs are powerful image classification tools that do not overly rely on preprocessing steps such as feature extraction and noise filtering. Note that other forms of machine learning, and / or artificial intelligence (Al) techniques and algorithms can be employed in alternate implementations as well.

[0080] D. Analysis and Measurement of Aspirated Particulate and Liquid Waste

[0081] Volumetric and optical analysis of aspiration liquid can be employed by the system and method. Techniques for measurement of liquid irrigation intake and aspirated waste output are well known to those skilled in the art.

[0082] These techniques have been found to prevent hypervolemia and hypovolemia in patients undergoing surgical procedures. An associated optical measurement of relative hemoglobin concentration can be advantageously included for assessment of intraoperative blood loss.

[0083] Optionally, an aspiration screen filter element (108 in Fig. 1) can be included in the associated irrigation / aspiration tubing set for the selective collection of pulverized excised stones, along with any other solid particulate or thrombus for subsequent analysis. Filtering elements designed to selectively capture particulate sizes of clinical interest can be removable prior to tubing set disposal.

[0084] IV. Imaging Sensors

[0085] An image sensing device (201 in Fig. 2) is provided as part of the system and method herein. A goal of such a device is to enhance and optimize the autonomous treatment path from a 3D perspective. Imaging can be achieved in various ways, including, but not limited to the use of 3D ultrasound and / or endoscopic optical imaging alone or fusion with prior MRI or other prior images. Where 3D ultrasound is employed, it can provide sufficient spatial resolution after performing a separate alignment step to register the 2D perspective ofDocket No.: 578 / 0002PCT the 3D (201 in Fig. 3) on the System Console UI together with a coplanar view of the treatment probe.

[0086] Distance measurements at more than one physiologically distinct anatomic location thereby allows for the use of machine learning derived pattern recognition as described herein. Hence, this combination results in previously unobtainable accuracy and speed for stone removal in the 1-2 mm range after just 15-20 minutes of overall treatment.

[0087] In an exemplary implementation, the sensing system can employ (e.g.) a customized stabilization arm apparatus (107 in Fig. 1) that is easily lockable and well suited for the surgical environment. Such an easily adjusted, articulated stabilization arm can thereby provide a solid platform for robotic fine mechanical adjustment of the treatment probe position and movement trajectory. The medical support arm design can be based upon previous designs reported in the literature. The treatment net probe robotic drive, with vertical, horizontal, and rotational movement can be interfaced to the medical support arm with additional customized attachment features. In an exemplary implementation by way of illustration without limitation, the medical support arm may offer six degrees of freedom to make it possible to target any point within a wide radius, allowing the operator to position the initial position of treatment probe exactly where a firm hold is needed. The medical support arm may provide a handle that when activated, allows guiding the arm to the desired point. As soon as the handle is released, the arm position is automatically locked.

[0088] In implementing the system and method, it is contemplated that the variation in stone sizes and desired treatment area across human subjects, and along with endoscopic image acquisition of the adjacent tissue surface, can be compared to baseline values for autonomous treatment control. A 3D model can be developed and allow determination of risk to unintended treatment areas, which can be displayed to the user prior to the initiation of treatment overlay ed on the medical images. This data can be employed in accordance with skill in the art to provide the appropriate path correction to the baseline treatment plan.

[0089] V. Operation of the System and Method

[0090] In a treatment environment with a patient, it is contemplated that the system and method can be deployed to autonomously position itself in the treatment area and deliver energy for stone resection and lithotripsy with pinpoint accuracy. An ovendew of this process 400 is provided in Fig 4.Docket No.: 578 / 0002PCT

[0091] Before the subject enters the procedure room, in step 410, and as further shown in the sub-procedure 500 of Fig. 5, operating room personnel unpack the sterile set (step 510) with aspiration container and install it on the system treatment cart (110 on Fig. 1). Then, the ultrasound probe is prepared for imaging (step 520). Finally, anew disposable probe net with fingers 1 ID and stone capture sheath 1 IE is affixed (step 530 to the treatment probe (104 on Fig. 1) with integrated endoscopic camera. The procedure 500 then returns to the next step 420 of Fig. 4.

[0092] As shown in detail in the sub-procedure 600 of Fig. 6, the patient is placed into the lithotomy position, draped and anesthetized in step 610. Then the rectal ultrasound probe (105 in Fig. 1) is inserted) and imaging is initiated through the 3rd party ultrasound console (step 620). Finally, the clinician / practitioner manually inserts the treatment delivery probe (step 630) under ultrasound guidance. Using the system console, a coplanar image of the treatment probe is aligned and adjusted to make ready for treatment planning (step 640), as shown in step 430 of the overall procedure 400.

[0093] As depicted in the sub-procedure 700 of Fig. 7, in step 710, the planning system console is then used to command the robotic treatment net probe motion control to move to the initial home location where treatment will be initiated. Then a proposed treatment plan can be drawn and refined on the screen (step 720). During this stage, the irrigation and aspiration pumps are started with a confirmation of adequate liquid flow (step 730).

[0094] Treatment (step 440) begins in sub-procedure 800 (Fig. 8), at step 810, when the treatment plan is approved and the clinician starts autonomous operation of the system (step 820). During treatment, the system console displays real time plan progress with measured parameters displayed until the plan is successfully completed (step 830). After stone resection, capture, lithotripsy and aspiration at the initial stone home location occur in Fig. 8, autonomous motion control to the next stone home location can then be initiated if treatment of more than one stone has been planned. The procedure 400 is otherw ise complete, and cleanup (step 450) can be implemented.

[0095] Thus, after completion of treatment steps, the sub-procedure 900 of Fig. 9 details cleanup steps. In step 910. the system stops pumping and reports out total captured aspiration liquid, including an intake / output analysis by volume, blood%, etc. If the optional particulate filter is utilized, it can be removed (step 920). At the end of the procedure, theDocket No.: 578 / 0002PCT entire used tubing set including the aspiration canister is disposed, ensuring no contact with biohazards (step 930). The operating room can then be reset to prepare for the next procedure (optional step 940), with the overall procedure 400 (Fig. 4) also complete.

[0096] VI. Autonomous Treatment

[0097] At the start of treatment, the cooling pump (222 in Fig. 2) delivers the intake cooled saline to the treatment area through the treatment probe (104 in Fig. 1) Simultaneously or concurrently, the aspiration pump (214 in Fig. 2) removes aspirated waste output to the aspiration canister. By means of autonomous rotation, horizontal, and vertical robotic motion control, the treatment probe (104 in Fig. 1) advances through the treatment area while removing stones located according to the 3D treatment plan outline, with hemostasis performed simultaneously.

[0098] During the entire treatment, the delivery unit (225 in Fig. 2) protects the surrounding tissue from thermal injury and managing hemostasis, while monitoring multiple parameters simultaneously. By way of non-limiting example, these parameters may include temperature, tissue impedance, etc. As part of autonomous motion control of the treatment probe (104 in Fig. 1) distance, location, and velocity is constantly compared to the desired treatment plan outline. The measured locations, depths and rotation angles are all archived, and can be transferred through the internet connection (208 in Fig. 2) for subsequent review.

[0099] At treatment completion, the cooling pump (222 in Fig. 2) stops, and the aspiration pump (214 in Fig. 2) removes the remaining aspirated waste output from the treatment area. Finally, the treatment probe (104 in Fig. 1) is retracted to its initial position for removal from the body, and subsequent cleanup and set up for the next case.

[0100] All autonomous steps herein can be performed using appropriate pattern recognition softw are applications with programmed decision making based upon recognized steps. Such software applications can be implemented using skill in the art based upon recognized / trained data.

[0101] A. Summary of Methodology

[0102] Based upon the foregoing description, the following generalized steps are applicable to the treatment method using the robotic system herein:1. Preparation (sterile set, ultrasound probe, treatment net probe);2. Insertion / Alignment (lithotomy position, begin imaging, treatment net probe, sonogram adjust);Docket No.: 578 / 0002PCT3. Positioning / Planning (home position, plan development, irrigation);4. Treatment (initiation, resection, pulverization, aspiration, hemostasis, motion control); and5. Cleanup (reports, filtered aspirate, disposal, O.R. reset).

[0103] B. Results

[0104] The illustrative system and method provides several advantages over existing systems. It improves the precision of stone treatment, minimizes the risk of collateral damage, and reduces recover}7times for patients. Additionally, the integration of stone removal and cooling functions into a single system offers a more streamlined and efficient workflow for surgeons. Autonomous operation further reduces the potential for human error, enhancing the overall safety and effectiveness of the procedure.

[0105] VIII. Conclusion

[0106] It should be clear that the image-guided autonomous treatment system and method for urological procedures provides a robust and desirable tool to provide enhanced surgical accuracy, reducing the potential for human error, while integrating multiple active treatment interventions to protect surrounding tissues. The novel system and method effectively combines different types of interventions into a single device — for example autonomous stone resection and removal, active cooling, intake / output volumetric analysis, with particulate capture. Treatment plans generated by the system and method can be refined using existing medical data that is processed with advanced computing procedures — such as classical machine learning, ensemble learning or other Al-based approaches.

[0107] The foregoing has been a detailed description of illustrative embodiments of the invention. Various modifications and additions can be made without departing from the spirit and scope of this invention. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments of the apparatus and method of the present invention, what has been described herein is merely illustrative of the application of the principles of the present invention. For example, as used herein, the terms "process" and / or "processor" should be taken broadly to include a variety of electronic hardware and / or software based functions and components (and can alternatively be termed functional "modules" or "elements"). Moreover, a depicted process or processorDocket No.: 578 / 0002PCT can be combined with other processes and / or processors or divided into various subprocesses or sub-processors. Such sub-processes and / or sub-processors can be variously combined according to embodiments herein. Likewise, it is expressly contemplated that any function, process and / or processor herein can be implemented using electronic hardware, software consisting of a non-transitory computer-readable medium of program instructions, or a combination of hardware and software. Additionally, as used herein various directional and dispositional terms such as "vertical", "horizontal", "rotational", "up", "down", "bottom", "top”, “side”, “front”, “rear”, “left”, “right”, and the like, are used only as relative conventions and not as absolute directions / dispositions with respect to a fixed coordinate space, such as the acting direction of gravity. Additionally, where the term "substantially” or “approximately" is employed with respect to a given measurement, value or characteristic, it refers to a quantity that is within a normal operating range to achieve desired results, but that includes some variability due to inherent inaccuracy and error within the allowed tolerances of the system (e.g., 1-5 percent). Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this invention.

[0108] What is claimed is:

Claims

Docket No.: 578 / 0002PCTCLAIMS1. A system for autonomous urologic stone removal from a region of a patient comprising: an imaging transducer that images the region in real time; a processor that receives the images and recognizes features therein related to the region; a robotic treatment probe constructed an arranged to be robotically inserted into and perform removal of the urological stone at the region based upon instructions from the processor; and an active cooling circuit that circulates predetermined volumes of fluid at the region.

2. The system as set forth in claim 1, further comprising an aspiration circuit that directs fluid from the region to a remote location for collection.

3. The system as set forth in claim 1, wherein the aspiration circuit captures fluid and enables volumetric analysis.

4. The system as set forth in claim 3, wherein the aspiration circuit includes a filter that captures particulates for analysis.

5. The system as set forth in claim 3, wherein the region is the peritoneal region.

6. The system as set forth in claim 1, further comprising a graphical user interface constructed and arranged to enable planning of a path of the surgery’ and treatment probe based upon real-time images overlaid on prior-acquired images from a scanning modality.

7. The system as set forth in claim 6, wherein the imaging transducer comprises an ultrasound transducer that provides images to a user.

8. A method for performing urological surgery with the system of claim 1, comprising the steps of:Docket No.: 578 / 0002PCT preparing the surgical site and locating the imaging transducer and treatment probe with respect to the region; locating a lithotripsy position, beginning imaging with the imaging transducer; inserting the treatment probe and adjusting a sonogram from the imaging transducer using a user interface; positioning the treatment probe at a home position, developing a treatment plan on the user interface and irrigating the region; and performing treatment of the region, including initiation, grasping of the stone with a finger assembly on the treatment probe, aspiration, hemostasis, based upon motion control of the treatment probe based upon the processor.

9. The method as set forth in claim 8, further comprising providing treatment reports to a a user, processing filtered aspirate from the region and disposal of waste.

10. The method as set forth in claim 9, further comprising, performing one or more of three discrete lithotripsy techniques that deliver energy to the stone to reduce the size thereof..

11. The method as set forth in claim 10, wherein the discrete lithotripsy techniques include at least one on RF energy, ultrasound energy and laser energy'.

12. The method as set forth in claim 11, wherein the lithotripsy techniques are monitored for energy delivery and at least one of energy delivery' and cooling is controlled based upon the monitoring.

13. The method as set forth in claim 8. further comprising, operating a graphical user interface for planning of a path of the treatment probe based upon real-time images overlaid on prior- acquired images from a scanning modality'.

14. The method as set forth in claim 13, wherein the images are derived from at least one of ultrasound. X-ray, CT and MRI scans.Docket No.: 578 / 0002PCT 15. The method as set forth in claim 8, wherein the imaging transducer is an ultrasound probe.

16. The method as set forth in claim 8, wherein the processor is adapted to operate the treatment probe autonomously.

17. The method as set forth in claim 16. wherein the processor employs a 3D treatment plan that maps a treatment region of the patient and follows program steps to perform the method.

Images