Systems and methods for laser catheter treatment in a vessel lumen

Abstract

Systems and methods for laser catheter treatment in a vessel lumen. The method includes inserting the laser catheter to a location of a treatment region within the vessel lumen; presenting an image of the treatment region within the vessel lumen based on using an ultrasound (US) imaging system; and detecting in real-time a bubble cloud dependent on laser catheter operation in the treatment region (at a prescribed speed and controlling flux and pulse rate). The method determines vessel diameter, real-time location and measurements of the bubble cloud, and estimates dwell location and dwell time. A dynamic display image is presented indicating progress of the laser catheter treatment, and a command to modify laser catheter parameters can be generated in response to the estimated dwell location, the estimated dwell time, and a recommended treatment regimen.

Description

Technical Field

[0001] This technical field generally relates to intravascular procedures, and more specifically, to systems and methods for laser catheter treatment within intravascular lumens. Background Technology

[0002] Intravascular procedures typically involve using a treatment device (such as a catheter) within the lumen of a blood vessel to clear blockages caused by clots or plaques and open the vessel. For optimal vessel treatment, the treatment device must be activated at one or more optimal locations for an optimal amount of time and moved along the treatment area. In the case of laser plaque resection, when the laser in the laser catheter is turned on or activated, the laser essentially drills a hole in the clot / plaque, thus creating a channel within the blood vessel lumen.

[0003] There are technical challenges in controlling the laser guide. If the laser guide does not leave a position quickly enough, this is described as an excessively long dwell time, and there is a risk that the area may be overtreated. If the laser guide leaves a position too quickly, this is described as an excessively short dwell time, and the area may be undertreated, thus failing to meet the desired treatment. Furthermore, each laser guide may have its own set of speed and activation time specifications.

[0004] Currently, the vast majority of laser plaque resection procedures are performed under X-ray guidance. Unfortunately, without contrast agents (which are usually not used), X-rays provide very limited information about vascular anatomy or the effectiveness of laser catheters.

[0005] Therefore, there is a need for technologically improved systems and methods for laser catheter treatment within vascular lumens. In addition to addressing the related problems, the following disclosure provides these technological enhancements. Summary of the Invention

[0006] This overview is provided to describe selected concepts in a simplified form, which are further described in the detailed embodiments. This overview is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0007] In one exemplary embodiment, a method for laser catheter treatment within a vascular lumen is provided. The method includes: inserting a laser catheter into a treatment area within the vascular lumen, the laser catheter having a distal tip that outputs laser light; presenting an image of the treatment area within the vascular lumen using an ultrasound (US) imaging system; operating the laser catheter within the treatment area, wherein the operation includes moving the laser catheter at a predetermined speed and controlling the flux and pulse rate of the laser light; detecting in real-time a bubble cloud extending from the distal tip using the US imaging transducer, the bubble cloud depending on the laser catheter operation within the treatment area; determining the vascular diameter and the real-time position and measurement of the bubble cloud; estimating the laser catheter dwell position and dwell time based on the real-time position and measurement of the bubble cloud; calculating the real-time degree of vascular obstruction based on the real-time position and measurement of the bubble cloud; presenting a dynamic display image of the vascular lumen and laser catheter operation, the dynamic display image indicating the progress of the laser catheter treatment; and generating a command to modify laser catheter parameters in response to the estimated dwell position, the estimated dwell time, and a recommended treatment plan.

[0008] Furthermore, in one embodiment, the method includes, in response to generating the command, presenting the command as an alphanumeric message for an operator to view, or automatically modifying the parameters of the laser conduit.

[0009] Furthermore, in one embodiment, the method includes changing the ultrasound system settings to an imaging mode in response to activation of the laser system.

[0010] Furthermore, in one embodiment, detecting the bubble cloud includes detecting acoustic reflections in the tissue medium, the acoustic reflections being generated by the interaction of the laser with the anatomical structures of the blood vessels.

[0011] Furthermore, in one embodiment, the method includes: determining the location of the bubble cloud by determining an origin near the output of the laser and a range furthest from the output of the laser; determining the measurement results of the bubble cloud by identifying sub-segments with different diameters, and for each sub-segment, storing the location, range, and corresponding diameter; and further includes periodically storing the location of the bubble cloud and the measurement results of the bubble cloud.

[0012] Furthermore, in one embodiment, the method includes: comparing the real-time position of the bubble cloud and the measurement result of the bubble cloud with the stored position of the bubble cloud and the measurement result of the bubble cloud to determine a change in position or a change in measurement result; and calculating the real-time degree of vascular occlusion based on the change in position or the change in measurement result.

[0013] Furthermore, in one embodiment, the real-time degree of vascular occlusion is presented as a percentage of the vascular diameter.

[0014] Furthermore, in one embodiment, the method includes moving the laser conduit at a predetermined speed, including moving the distal end of the conduit longitudinally from a point before the treatment area to a point near the end of the treatment area.

[0015] In another exemplary embodiment, a system for laser catheter treatment within a vascular lumen is provided. The system includes: a laser catheter having a distal tip for outputting laser light, the laser catheter having operating parameters of predetermined velocity, flux, and pulse rate; an ultrasound (US) system configured to detect a bubble cloud associated with the operation of the laser catheter in a treatment area within the vascular lumen and to generate a US signal based thereon; and a control system operatively coupled to the laser catheter and the ultrasound system, the control system being programmed to: receive the ultrasound signal; determine the vascular diameter and the real-time position and measurement result of the bubble cloud based on the US signal; estimate the laser catheter dwell position and associated dwell time based on the real-time position of the bubble cloud and the measurement result; present a dynamic display image of the vascular lumen and laser catheter operation on a display system; generate a command to modify the laser catheter parameters in response to the estimated dwell position, the estimated dwell time, and a recommended treatment plan; and, in response to generating the command, present the command as an alphanumeric message on the display system for operator viewing, or automatically modify the laser catheter parameters.

[0016] Furthermore, in an embodiment, the control system is also programmed to detect acoustic reflections in the tissue medium, the acoustic reflections being generated by the interaction of the laser with the anatomical structures of the blood vessels.

[0017] Furthermore, in an embodiment, the control system is also programmed to: determine the position of the bubble cloud by determining the origin 34 near the output of the laser 11 and the range 38 furthest from the output of the laser; determine the measurement result of the bubble cloud by identifying sub-segments with different diameters and, for each sub-segment, storing the position, range, and corresponding diameter; and periodically store the position of the bubble cloud and the measurement result of the bubble cloud.

[0018] Furthermore, in an embodiment, the control system is also programmed to: compare the real-time position of the bubble cloud and the measurement result of the bubble cloud with the stored position and measurement result of the bubble cloud to determine a change in position or a change in measurement result; and calculate the real-time degree of vascular occlusion based on the change in position or the change in measurement result.

[0019] Furthermore, in this embodiment, the control system is also programmed to calculate the real-time degree of vascular occlusion and display it on the display system.

[0020] Furthermore, in an embodiment, the control system is also programmed to present the real-time degree of vascular occlusion as a percentage of the vascular diameter on the display system.

[0021] Furthermore, in an embodiment, the control system is also programmed to estimate the residence velocity and the residence time based on the detected movement of the distal end of the catheter in the treatment area.

[0022] Furthermore, in an embodiment, the control system is also programmed to change the ultrasonic system settings in response to the operation of the laser system.

[0023] In another exemplary embodiment, a system is provided for laser catheter treatment within a vascular lumen. The system includes: a laser plaque resection system having configurable operating parameters specifying speed, throughput, and pulse rate, the configurable operating parameters controlling an associated laser catheter outputting laser light from a distal tip; an ultrasound (US) system configured to detect a cloud of carbon dioxide or carbon monoxide bubbles generated by the interaction of the laser with anatomical structures of the vessel within the treatment area of ​​the vascular lumen, and to generate a US signal based thereon; a display system configured to present dynamic images of the vascular lumen and the laser catheter treatment; and a control system 108 operable... The control system is coupled to a laser plaque resection system, a US system, and a display system. The control system is configured via computer-readable programming instructions to: receive the US signal; determine the real-time position and measurement results of the bubble cloud based on the US signal; estimate the laser catheter dwell position and associated dwell time based on the real-time position and measurement results of the bubble cloud; generate a command to modify the laser catheter parameters in response to the estimated dwell position, the estimated dwell time, and a prescribed treatment plan; and, in response to generating the command, present the command as an alphanumeric message on the display system for operator viewing, or automatically modify the laser catheter parameters.

[0024] Furthermore, in an embodiment, the control system is also configured to: determine the position of the bubble cloud by determining the origin 34 near the output of the laser and the range furthest from the output of the laser; identify sub-segments of the bubble cloud with different shapes, and for each sub-segment, measure the position, range, and corresponding diameter; and periodically store the position of the bubble cloud and the measurement results of the sub-segments of the bubble cloud.

[0025] Furthermore, in an embodiment, the control system is also configured to: compare real-time measurement results of a sub-segment of the bubble cloud with stored measurement results of the sub-segment of the bubble cloud to determine changes in the measurement results; and calculate the real-time degree of vascular occlusion based on the changes in the measurement results.

[0026] Furthermore, in an embodiment, the control system is also programmed to change the US system mode settings in response to activating the laser system.

[0027] Furthermore, other desirable features and characteristics of the system and method will become apparent from the following detailed description and appended claims, in conjunction with the accompanying drawings and the foregoing background. Attached Figure Description

[0028] This disclosure will be described below in conjunction with the accompanying drawings, wherein the same numerals denote the same elements, and:

[0029] Figure 1 This is a block diagram of a system for laser catheter treatment within a blood vessel lumen, according to an exemplary embodiment.

[0030] Figure 2-4 The illustration shows a simplified screenshot of the dynamic progression of an ultrasound image generated during laser catheter treatment in a treatment area within a blood vessel lumen, according to an embodiment; and

[0031] Figure 5 This is a flowchart of a method system for laser catheter treatment in a blood vessel lumen, according to an exemplary embodiment. Detailed Implementation

[0032] The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and use of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Therefore, any embodiment described herein as "exemplary" is not necessarily to be construed as superior to or better than other embodiments. The embodiments described herein are provided as exemplary embodiments to enable those skilled in the art to make or use the invention without limiting the scope of the invention as defined by the claims. Furthermore, no explicit or implicit theory presented in the foregoing technical field, background art, summary of the invention, or the following detailed description is intended to bind you.

[0033] As mentioned above, there are technical challenges in controlling laser guides. If the laser guide does not leave a position quickly enough, this is described as an excessively long dwell time, and there is a risk that the area may be overtreated. If the laser guide leaves a position too quickly, this is described as an excessively short dwell time, and the area may be undertreated, thus failing to meet the desired treatment. Furthermore, each laser guide or guide can have its own set of speed and activation time specifications.

[0034] Currently, the vast majority of laser plaque resection procedures are performed under X-ray guidance. Unfortunately, without contrast agents (which are typically not used), X-rays provide very limited information about vascular anatomy. This lack of information presents clinicians with several challenges:

[0035] • Visualizing the vessel walls during treatment: Because soft tissue is not visible under X-rays, clinicians can only see the device in 2D during treatment. Instead, they must remember where they have treated and how long the device has been activated at each location. This requires building a mental map of the treatment, which demands considerable experience.

[0036] • It is difficult to apply contrast agents during the procedure because it requires removing or repositioning the laser catheter from the treatment area. Therefore, the only confirmation of the procedure occurs afterward.

[0037] Similarly, lesions and plaques are difficult to see under X-rays. Even with contrast agents, lesions are often missed, leading to undertreatment and a high restenosis rate.

[0038] • It is difficult for doctors to follow the prescribed speed and activation time for treatment, so some blood vessels may be overtreated or undertreated.

[0039] • Visualizing tortuous blood vessels using only 2D X-ray images may lead to ineffective treatment. This can result in undertreatment, as doctors may quickly guide a catheter through the bend without realizing the disease is present at the bend.

[0040] Complications during plaque excision, such as vascular injury and dissection, are difficult or impossible to detect on X-ray alone.

[0041] Some solutions have attempted to use ultrasound (US) imaging systems, but have encountered problems due to variations in the quality of visualization of vascular / anatomical structures, which can also vary due to a variety of factors, such as the tissue involved, the percentage of fat, the thickness of the subcutaneous fat layer, etc.

[0042] Exemplary embodiments use control systems ( Figure 1The technical solution to this problem is provided in the form of 108), which embodies novel rules, vascular anatomy design factors and recommended treatment protocols for combining laser catheter treatment using laser plaque resection systems and methods with ultrasound (US) imaging, as described below.

[0043] Laser plaque resection systems and methods for laser catheter-based treatment within blood vessels utilize laser energy derived from the laser catheter. When the laser energy is activated within the blood vessel, the surrounding water evaporates due to the low-pressure environment, forming a large cloud of water vapor bubbles at the distal tip of the catheter. Tunable operating parameters in the laser plaque resection system are the pulse rate and pulse intensity. The lifetime of the bubble cloud can range from 50 µs to 300 µs, while the diameter can be up to 3 mm. The size of the bubble cloud is substantially related to the energy level (higher energy produces larger bubbles). During cavitation, it breaks down into smaller bubbles and continues downstream or backward from its origin. These downstream bubble clouds are gaseous products of photochemical reactions with blood / tissue / contrast agents. The concentration of hemoglobin affects the size of the bubble cloud. Laser activation in the contrast agent generates significant amounts of carbon monoxide (CO) and carbon dioxide (CO2).

[0044] Ultrasound (US) images are based on the reflection of sound waves from the tissue medium. The aforementioned bubbles generated during laser activation exhibit strong reflections and therefore appear bright on US images. The provided embodiments detect and measure bubble clouds on ultrasound (US) images.

[0045] The disclosed control system 108 forms a closed-loop control between a laser plaque resection system (with an associated laser catheter) and an ultrasound (US) imaging system configured to detect bubble clouds generated by the operation of the laser catheter. Vascular anatomy design factors and recommended treatment protocols include identifying and measuring thresholds for these bubble clouds within the vascular lumen and various types of treatment areas. The disclosed control system 108 also generates commands, presents images for treatment monitoring on a display system, and receives user input from a user interface.

[0046] The provided embodiments offer an improved human-machine interface for real-time evaluation of laser catheter efficacy under ultrasound (US). Technical improvements include providing feedback loops to physicians and / or laser plaque resection systems to guide the laser catheter for optimal treatment. The provided embodiments aid in treatment monitoring by acquiring, processing, and visualizing ultrasound images of bubbles generated during treatment by the interaction of the laser with tissue. Real-time processing of ultrasound images between the laser plaque resection system and the US system via a bidirectional communication controller system enables automatic US system mode switching, automatic calculation of treatment dwell time, and automatic adjustment of imaging and laser delivery parameters (flux and pulse rate). Further details are provided in the following figures and description.

[0047] Now go to Figure 1 In embodiments, a system 100 (also referred to herein as "system" 100) for intravascular laser catheter treatment is described as being associated with an intravascular lumen 12. In various embodiments, the intravascular lumen 12 is a blood vessel within a patient's body. As described above, system 100 includes a control system 108 operatively coupled to a laser plaque resection system 102 via a bidirectional connection 126 and operatively coupled to an ultrasound system 104 via a bidirectional connection 124. Both connections 124 and 126 may include, but are not limited to, direct hardwired connections, fiber optics, infrared, and / or wireless bus technologies. In various embodiments, control system 108 may also be operatively coupled to a display system 110 and a user interface 112. Although the control system 108 is depicted as a separate functional block for discussion purposes, it will be understood that in some embodiments, the control system 108 may be integrated into any combination of the existing laser plaque resection system 102, display system 110, and user interface 112; in other embodiments, the control system 108 may be integrated into any combination of the existing ultrasound system 104, display system 110, and user interface 112. The functions of these systems and their interactions are described in more detail below.

[0048] Laser plaque resection system 102 includes a laser emitting ( Figure 3 The laser conduit 10 (17) can be manually operated by the user; manual input may include speed, dwell time, and direction. Viewed from the distal tip of the laser conduit, this direction is typically within the lumen of the blood vessel ( Figure 2 Longitudinally forward and backward within the treatment area (12). The laser plaque resection system 102 typically controls the flux and pulse rate of the laser 17 in response to user input. User input can be provided via user interface 112 and / or a combination of user input and predefined treatment options selected by the user. Within the treatment area ( Figure 2 Operating the laser conduit (10) in (16) includes moving the laser conduit (10) at a predetermined speed and controlling laser conduit parameters, such as the flux and pulse rate of the laser (17). In various embodiments, as described in more detail below, the control system 108 can automatically modify the laser conduit parameters.

[0049] Ultrasound system 104 employs ultrasound transducer 106 and supporting circuitry to detect information at 122 (from the lumen 12 of the blood vessel and surrounding anatomical structures) and convert the detected information into ultrasound signals transmitted via connection 124 for further processing by control system 108 and display on display system 110. As used herein, the information detected at 122 is in the form of a bubble cloud, and detecting the bubble cloud includes detecting carbon dioxide and / or carbon monoxide, both generated by the interaction of laser 17 and the anatomical structures of the blood vessel. Inputs from control system 108 to ultrasound system 104 may include ultrasound system settings such as image zoom, contrast, and repositioning.

[0050] User interface 112 and control system 108 are cooperatively configured to allow a user to interact with the display device in display system 110 and / or other components of system 100, as described herein. Depending on the embodiment, user interface 112 may be implemented as a cursor control device (CCD), keypad, touchpad, keyboard, mouse, touch panel (or touchscreen), joystick, knob, line selection key, voice controller, gesture controller, or another suitable device adapted to receive input from the user. When user interface 112 is configured as a touchpad or touchscreen, it can be integrated with display system 110.

[0051] The control system 108 generates display commands for the display system 110 to present images for treatment monitoring thereon. As described herein, images may include pictures plus any of various alphanumeric messages, graphical user interface elements, tables, icons, alarms, menus, and buttons. The display system 110 is configured to continuously receive and process display commands from the control system 108. In the various embodiments described herein, the display system 110 may present two-dimensional or three-dimensional images and may be implemented on one or more electronic display devices configured collaboratively. Drawing on the display system 110 may be handled by a graphics system, components of which may be integrated into the display system 110 and / or integrated within the control system 108. The display method also includes various formatting techniques for visually distinguishing objects from other similar objects.

[0052] Control system 108 performs the functions of system 100. As used herein, control system 108 refers to any means for facilitating communication and / or interaction between elements of system 100 and performing additional processes, tasks, and / or functions to support the operation of system 100, as described herein. In various embodiments, control system 108 may be any hardware, software, firmware, electronic control components, processing logic, and / or processor device, individually or in any combination. Depending on the embodiment, control system 108 may be implemented or carried out using: a general-purpose processor, a (shared, dedicated, or group) controller, a microprocessor, or a microcontroller, and memory executing one or more software or firmware programs; content-addressable memory; a digital signal processor; an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA); any suitable programmable logic device; combinational logic circuits including discrete gate or transistor logic; discrete hardware components and memory devices; and / or any combination thereof.

[0053] Therefore, in Figure 1 In this context, embodiments of the control system 108 are depicted as an enhanced computer system including a processor 116 and a computer-readable medium, and a memory 118. Typically, the memory 118 holds data bits and can be used by the processor 116 as a storage device and / or temporary register during operation. Information in the memory 118 can be organized and / or imported from external data sources during the initialization steps of a process or method; it can also be programmed via a user interface 112. Figure 1 In one embodiment, memory 118 stores instructions and applications, including a novel program 130 having rules and programming instructions that, when executed, configures processor 116 / memory 118 into control system 108 to perform functions, techniques, and processing tasks 100 associated with the operation of the system.

[0054] In various embodiments, the processor / memory unit of the control system 108 is communicatively coupled to the input / output (I / O) interface 120. The I / O interface 120 enables communication within the control system 108, as well as communication between the control system 108 and other components of the system 100. The I / O interface 120 may include one or more network interfaces and can be implemented using any suitable methods and means. In various embodiments, the I / O interface 120 is configured to support communication from external system drivers and / or another computer system. In one embodiment, the I / O interface 120 obtains data directly from one or more external data sources. Furthermore, in various embodiments, the I / O interface 120 may support communication with technicians and / or one or more storage interfaces for direct connection to storage devices.

[0055] Those skilled in the art will recognize that the mechanisms of this disclosure are capable of being distributed as a program product. As a program product, program 130 can be stored and distributed using one or more types of non-transient computer-readable signal-bearing media, such as a non-transient computer-readable medium carrying program 130 and containing additional computer instructions for causing a computer processor (e.g., processor 116) to load and execute program 130. Such program products can take various forms, and this disclosure applies equally regardless of the type of computer-readable signal-bearing medium used for distribution. Examples of signal-bearing media include recordable media such as floppy disks, hard disks, memory cards, and optical disks, and transmission media such as digital and analog communication links. It should be understood that cloud-based storage and / or other technologies may also be utilized in some embodiments.

[0056] Now go to Figure 2-4 Figures 5-7 provide non-limiting examples for illustrating technological enhancements relative to other laser catheter treatment systems. Figure 2 , 3 Images 5-7 of Figures 4 and 4 illustrate simplified screenshots of the dynamic progression of ultrasound images generated during treatment of a laser catheter in the treatment area 16 of the vascular lumen 12 according to an embodiment. Figure 2 , 3 The images of the US system 104 and the laser plaque resection system 102 are presented on the display system 110 in response to the control system 108, and are understood to be in response to the continuous acquisition and processing of data from the US system 104 and the laser plaque resection system 102. Figure 2 , 3 The images of 1 and 4 are illustrated as two-dimensional, but in reality, the images can be three-dimensional. Regardless of whether the images shown are two-dimensional or three-dimensional, it should be understood that the measurements of the vascular endothelial structures described herein, as well as the bubble cloud 18 and vascular occlusion 14, are volumetric or three-dimensional.

[0057] Prior to operation of system 100, control system 108 is initialized to calibrate a specific laser plaque resection system 102, a specific laser catheter 10, and a specific ultrasound system 104. Calibration enables control system 108 to synchronize the operation and parameter changes of laser catheter 10 with the expected laser 17 output and with received information from ultrasound system 104. In one example, control system 108 may cause both ultrasound system 104 and laser plaque resection system 102 to send clock signals or timestamps, then align the two system clocks. In another example, control system 108 may act as a trigger, sending clock signals or timestamps to both ultrasound system 104 and laser plaque resection system 102, causing them to be activated simultaneously. Additionally, activation of laser plaque resection system 102 may trigger ultrasound system 104 to automatically switch to a specific imaging mode, such as a contrast mode or other customized mode optimized for visualizing bubbles to monitor treatment.

[0058] The laser guide tube (10) is operated within the treatment area (16), wherein the operation includes moving the laser guide tube at a predetermined speed and controlling laser guide tube parameters, including the flux and pulse rate of the laser (17). The predetermined speed may be a distance traveled at each step along the length of the treatment area 16, possibly with a certain margin. For example, refer to... Figure 4 The laser guide 10 can be moved such that the distal end 11 moves within the treatment area 16 between point 34 before the start of the treatment area and point 36 near the end of the treatment area (in Figure 4 In the treatment area 16, the beginning is on the left, near the initial insertion point of the distal tip 11, and the end is on the right. The laser conduit 10 can move back and forth more than once within the treatment area 16. Operation of the laser conduit 10 results in the generation of carbon dioxide and carbon monoxide, both generated by the interaction of the laser 17 and the anatomical structures of the blood vessel. The US system 104 uses a US ultrasound transducer 106 to detect in real time a bubble cloud (18) extending from the distal tip (11), which depends on the operation of the laser conduit within the treatment area 16.

[0059] The control system 108 processes the information received from the ultrasound system 104 and uses strong echo visualization and rules encoded into program 130 to determine the vessel diameter (28) and the real-time position and volume measurements of the bubble cloud. Using the detected bubble cloud determination, the control system 108 can estimate the movement of the distal end 11 of the laser catheter in the treatment area 16, as well as the corresponding residence velocity and residence time.

[0060] Determining the location of the bubble cloud involves identifying the origin at point 34 near the output of laser 11 and the range 38 furthest from the laser output. Determining the measurement results of the bubble cloud involves identifying sub-segments (20, 22, 24) with different shapes and diameters, and for each sub-segment, storing the location, range, and corresponding diameter. The control system 108 can compare the real-time measurement results of the sub-segments of the bubble cloud with the stored measurement results to determine changes in the measurement results; and calculate the real-time degree of vascular blockage 14 based on these changes. The control system 108 can also periodically store the location and measurement results of the bubble cloud.

[0061] In the provided example, the bubble cloud exhibits a skeletal shape, and the volume measurements of the bubble cloud (20, 22, 24, 26, 28, 30) include measurements of the following sub-segments: a circular sub-segment (length 20) near the distal tip 11 of catheter 10; a narrow sub-segment (length 22) in the region of thickest vascular occlusion (vascular occlusion 14 is shown as reducing throughput to a diameter 26 at the thickest region, rather than the total vascular diameter 28); and a return to the circular segment (length 24) and diameter 28. It is understood that other bubble cloud shapes can be generated, and for each bubble shape, system 100 will utilize rules encoded into program 130 in a similar process as described herein to segment the bubble shape into sub-segments and determine the measurements. Control system 108 can calculate the real-time degree of vascular occlusion (14) based on the real-time location of the bubble cloud and the measurements.

[0062] The control system 108 can also perform time analysis by estimating the overall velocity of the bubbles throughout the bubble cloud. Due to the known principle of energy decay over time, it can be expected that bubbles at the distal tip 11 of the catheter will have the highest velocity, and bubbles farther from the tip will travel more slowly. In various embodiments, bubble velocity information can be combined with the estimated dwell position of the device to improve the accuracy of distal tip 11 detection compared to using either mode alone. For example, this could be helpful during long treatment periods when the treatment area is filled with bubbles; in this case, the vascular lumen is completely hyperechoic due to the saturation of bubbles and the laser catheter 10, and many occlusions should exist as hyperechoic structures, but the distal tip 11 of the laser catheter is the only moving hyperechoic structure.

[0063] The control system 108 presents dynamic display images for use during treatment monitoring (e.g., images 5, 6, and 7 indicate the progress of laser catheter treatment). The control system 108 estimates the aforementioned dwell positions (e.g., from point 34 to point 36) and associated dwell times for various dwell positions based on the real-time position and measurements of the bubble cloud 18. As used herein, dwell time is the amount of time the activated laser 17 spends at a given dwell position; and the dwell position can vary from a starting point to an ending point (e.g., from point 34 to point 36, where the area between point 36 and the bubble boundary 38 represents the extent of the bubble cloud emitted from the distal tip 11 when the distal tip 11 is at position 36 and from which the laser 17 is generated). These estimates can be presented on the display system 110 for treatment monitoring.

[0064] The control system 108 can use the bubble cloud shape and measurement results to measure and present the progress of treatment during therapeutic monitoring. In various embodiments, the control system 108 compares the real-time position and measurement results of the bubble cloud with stored bubble cloud positions and measurements to determine positional changes or measurement changes; the control system 108 can calculate the real-time degree of vascular occlusion 14 based on the positional changes or measurement changes. In various embodiments, the real-time degree of vascular occlusion 14 is presented as a percentage of the vessel diameter 28.

[0065] exist Figure 4 In the diagram, after at least some treatments have been performed, the final area of ​​the thickest vascular blockage 14 is shown to be reduced; that is, the throughput in the treated area has increased to a diameter of 30 at the thickest region, instead of the total vascular diameter of 28. As depicted, diameter 30 is smaller than diameter 28, but larger than diameter 26 before treatment.

[0066] In various embodiments, the control system 108 generates a command to modify the laser conduit parameters in response to an estimated dwell position, an estimated dwell time, and a recommended treatment plan. In various embodiments, in response to generating the command, the control system 108 presents the command as an alphanumeric message for operator viewing. In various embodiments, in response to generating the command, the control system 108 automatically modifies the laser conduit parameters. In various embodiments, the control system 108 changes the settings of the US system 104 in response to operation of the laser conduit.

[0067] During operation, the control system 108 can provide any of the following characteristics based on the measurements it performs, processes, and stores: The control system 108 can identify gaps of insufficient residence time in anatomical structures and / or anticipate potential overtreatment and generate corresponding alphanumeric warnings and guidance. The practitioner can use feedback to maintain a residence time profile as consistent as possible throughout the vessel. The control system 108 can continuously adjust the power (flux) / pulse rate based on the residence time and velocity of the catheter as it is pushed.

[0068] System 100 can be based on, for example Figure 5 The method is one of 500 methods for determination and selection. Continue to refer to... Figure 1-4 A flowchart of a method 500 for providing a system 100 according to various exemplary embodiments is provided. Method 500 illustrates various embodiments of a method for selecting an accurate runway record. For illustrative purposes, the following description of method 500 may be referenced in conjunction with the above. Figure 1 The mentioned components. In practice, parts of method 500 can be performed by different components of the described system. It should be understood that method 500 can include any number of additional or alternative tasks. Figure 5 The tasks shown do not need to be performed in the illustrated order, and method 500 can be incorporated into a more comprehensive procedure or method with additional functionality not described in detail herein. Furthermore, if the intended overall functionality remains intact, it can be omitted from embodiments of method 500. Figure 5 One or more tasks are shown.

[0069] The method begins, and at 502, the control system 108 is initialized while system 100 is running. Initialization may include uploading or updating algorithms embodied in program 130, various lookup tables (such as prescribed treatment protocols), various laser catheter-specific operating guidelines, default parameters, predetermined dwell times and distance thresholds, and various shapes, colors, and / or visual differentiation techniques for icon and alphanumeric displays. In some embodiments, program 130 includes additional instructions and rules for drawing information differently based on the type of US system 104 and / or the type of display device in display system 110.

[0070] At 504, the method includes inserting a laser conduit 10 into a treatment area 16 within the lumen of a blood vessel, the laser conduit having a distal tip 11 for outputting a laser 17. At 506, the method includes presenting an image of the treatment area within the lumen of the blood vessel using an ultrasound (US) imaging system 104. At 508, the laser conduit 10 is manipulated within the treatment area 16, wherein the manipulation includes moving the laser conduit at a predetermined speed and controlling the flux and pulse rate of the laser 17.

[0071] At 510, an ultrasonic imaging transducer is used to detect in real time a bubble cloud 18 extending from the distal tip 11, which depends on the laser catheter operation in the treatment area. At 512, the vessel diameter 28 and the real-time position and measurement of the bubble cloud 18 are determined. At 514, the method includes estimating the laser catheter dwell position (e.g., from point 34 to point 36) and dwell time based on the real-time position and measurement of the bubble cloud. At 516, the method can determine the degree of vessel blockage 14 based on the real-time position and measurement of the bubble cloud. At 518, the method includes presenting dynamic display images (5, 6, 7) of the vessel lumen and laser catheter operation, indicating the progress of laser catheter treatment. At 520, the method includes generating a command to modify laser catheter parameters in response to the estimated dwell position, estimated dwell time, and recommended treatment protocol. In some embodiments, at 522, the method includes presenting the command as an alphanumeric message for operator viewing in response to the generated command. In other embodiments, at 522, the method includes automatically modifying the parameters of the laser conduit 10 in response to a generation command.

[0072] In the example, guidelines for plaque resection stored as prescribed procedures could suggest an optimal speed for advancing the laser catheter 10 in the range of 1-2 mm / sec. The estimated dwell time can be used to provide the user with a speed indication on the display system 110, along with guidance on whether to accelerate or decelerate. For example, if the control system 108 determines that the catheter is positioned against a vascular obstruction (e.g., a plaque), the indication would suggest slowing down and spending more time around the plaque. Conversely, if the control system 108 determines that the catheter is passing through a healthy blood vessel, it would suggest increasing the speed.

[0073] At 524, the method can optionally change the settings of the US system 104 in response to the operation of the laser guide tube 10.

[0074] Therefore, a technically enhanced system 100 for laser catheter treatment is provided, featuring an improved human-machine interface. The provided system 100 includes a control system 108 that utilizes data and information from a US system 104 and a laser plaque resection system 102 to present dynamic display images (5, 6, 7) of the operation of the vascular lumen 12 and the laser catheter 10, indicating the progress of the laser catheter treatment. As will be readily understood, the above examples of system 100 are non-limiting, and many other examples can be achieved by the control system 108.

[0075] Those skilled in the art will recognize that the various illustrative logic blocks, modules, circuits, and algorithm steps described in conjunction with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or a combination of both. Some embodiments and implementations have been described above with respect to functionality and / or logic block components (or modules) and various processing steps. However, it should be understood that such block components (or modules) can be implemented by any number of hardware, software, and / or firmware components configured to perform the specified functions. To clearly illustrate the interchangeability of hardware and software, the various illustrative components, blocks, modules, circuits, and steps have been generally described above with respect to their functionality. Whether this functionality is implemented as hardware or software depends on the application and the design constraints imposed on the overall system.

[0076] Skilled technicians can implement the described functions in various ways for each application, but such implementation should not be construed as departing from the scope of the invention. For example, embodiments of the system or component may employ various integrated circuit components, such as memory elements, digital signal processing elements, logic elements, lookup tables, etc., which can perform various functions under the control of one or more microprocessors or other control devices. Furthermore, those skilled in the art will recognize that the embodiments described herein are merely exemplary implementations.

[0077] Furthermore, the various illustrative logic blocks, modules, and circuits in conjunction with the embodiments disclosed herein can be implemented or performed by general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs) or other programmable logic devices, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may also be executed as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0078] The steps of the methods or algorithms described in conjunction with the embodiments disclosed herein may be directly embodied in hardware, a software module executed by a controller or processor, or a combination of both. The software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to a processor such that the processor can read information from and write information to the storage medium. Alternatively, the storage medium may be an integral part of the processor. The processor and storage medium may reside in an ASIC.

[0079] In this document, relational terms such as "first" and "second" may be used alone to distinguish one entity or action from another, without necessarily requiring or implying any actual such relationship or order between these entities or actions. Ordinal numbers such as "first," "second," "third," etc., merely represent different entities among a plurality and do not imply any order or sequence unless explicitly defined by the language of the claims. A literal sequence in any claim does not imply that the processing steps must be performed in a temporal or logical order according to such a sequence, unless explicitly defined by the language of the claims. The processing steps may be interchanged in any order, provided that such interchange does not violate the language of the claims and is not logically meaningless, and does not depart from the scope of the invention. When "or" is used herein, it is logical or mathematical, also known as "inclusive or." Thus, A or B is true for three cases: A is true, B is true, and A and B are true. In some cases, an exclusive "or" is constructed using "and"; for example, "from one of sets A and B" is true for two cases: A is true, and B is true.

[0080] Furthermore, the use of terms such as “connected” or “coupled to” in describing the relationship between different elements, depending on the context, does not necessarily mean that there must be a direct physical connection between these elements. For example, two elements may be connected to each other physically, electrically, logically, or in any other way through one or more additional elements.

[0081] Although at least one exemplary embodiment has been given in the foregoing detailed description of the invention, it should be appreciated that numerous variations exist. It should also be understood that one or more exemplary embodiments are merely examples and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient roadmap for carrying out exemplary embodiments of the invention. It should be understood that various changes can be made to the function and structure of the elements described in the exemplary embodiments without departing from the scope of the invention as set forth in the appended claims.

Claims

1. A computer program product comprising a computer program adapted to cause a processor to perform a method for laser catheter treatment in a vessel lumen when the computer program is run on the processor, the method comprising: inserting the laser catheter to a position of a treatment region within the vessel lumen, the laser catheter having a distal tip that outputs laser light; presenting an image of the treatment region within the vessel lumen based on using an ultrasound (US) imaging system; operating the laser catheter in the treatment region, wherein operating includes moving the laser catheter at a prescribed speed and controlling a flux and a pulse rate of the laser light; detecting in real-time a bubble cloud extending from the distal tip using the US imaging transducer, the bubble cloud depending on laser catheter operation in the treatment region; determining a vessel diameter and real-time location and measurements of the bubble cloud; estimating a laser catheter dwell location and dwell time from the real-time location and the measurements of the bubble cloud; calculating a real-time degree of vessel occlusion from the real-time location and the measurements of the bubble cloud; presenting a dynamic display image of the vessel lumen and laser catheter operation, the dynamic display image indicating progress of the laser catheter treatment; and generating a command to modify laser catheter parameters in response to the estimated dwell location, the estimated dwell time, and a recommended treatment regimen.

2. The computer program product of claim 1, the method further comprising presenting the command as an alphanumeric message for an operator to view or automatically modifying parameters of the laser catheter in response to generating the command.

3. The computer program product of claim 2, the method further comprising changing a US system setting to an imaging mode in response to activation of a laser system.

4. The computer program product of claim 1, wherein, Detecting the bubble cloud includes detecting acoustic wave reflections from bubbles in a tissue medium, the acoustic wave reflections generated by interaction of the laser light with an anatomical structure of the vessel.

5. The computer program product of claim 4, wherein: determining a location of the bubble cloud includes determining an origin near an output of the laser light and a range furthest from the output of the laser light; determining measurements of the bubble cloud includes identifying sub-sections having different diameters and, for each sub-section, storing a location, a range, and a corresponding diameter; and further comprising periodically storing the location of the bubble cloud and the measurements of the bubble cloud.

6. The computer program product of claim 5, the method further comprising, comparing the real-time location of the bubble cloud and the measurements of the bubble cloud to the stored location of the bubble cloud and the measurements of the bubble cloud to determine a location change or a measurement change; and calculating the real-time degree of vessel occlusion from the location change or the measurement change.

7. The computer program product of claim 5, wherein, the real-time degree of vessel occlusion is presented as a percentage of a vessel diameter.

8. The computer program product of claim 1, wherein, moving the laser catheter at a prescribed speed includes moving a distal end of the catheter longitudinally from a point before the treatment region to a point near an end of the treatment region.

9. A system for laser catheter treatment in a vessel lumen, comprising: a laser catheter having a distal tip that outputs a laser, the laser catheter having prescribed operating parameters of velocity, fluence, and pulse rate; an ultrasound (US) system configured to detect a bubble cloud associated with operation of the laser catheter in a treatment region within the vessel lumen and generate a US signal therefrom; a control system operably coupled to the laser catheter and US system, the control system programmed to: receive the US signal; determine from the US signal a vessel diameter and real-time location and measurements of the bubble cloud; estimate a laser catheter dwell location and associated dwell time from the real-time location and measurements of the bubble cloud; present a dynamic display image of the vessel lumen and laser catheter operation on a display system; generate a command to modify the laser catheter parameters in response to the estimated dwell location, estimated dwell time, and a recommended treatment protocol; and in response to generating the command, present the command as an alphanumeric message on the display system for an operator to view, or automatically modify the laser catheter parameters. the control system is further programmed to detect acoustic wave reflections from bubbles in a tissue medium, the acoustic wave reflections generated from interaction of the laser with the anatomy of the vessel.

10. The system of claim 9, wherein, the control system is further programmed to:

11. The system of claim 10, wherein, determine a location of the bubble cloud by determining an origin (34) near an output of the laser (11) and a range (38) furthest from the output of the laser; determine measurements of the bubble cloud by identifying sub-sections having different diameters, and for each sub-section, storing a location, a range, and a corresponding diameter; and periodically store the location of the bubble cloud and the measurements of the bubble cloud. the control system is further programmed to: compare the real-time location of the bubble cloud and the measurements of the bubble cloud to stored locations of the bubble cloud and measurements of the bubble cloud to determine a location change or a measurement change; and 12. The system of claim 11, wherein, calculate a real-time degree of vessel occlusion from the location change or the measurement change. the control system is further programmed to calculate a real-time degree of vessel occlusion and present it on the display system. the control system is further programmed to present the real-time degree of vessel occlusion as a percentage of vessel diameter on the display system.

13. The system of claim 12, wherein, the control system is further programmed to estimate a dwell velocity and the dwell time based on detected movement of a distal end of the catheter in the treatment region.

14. The system of claim 13, wherein, the control system is further programmed to change US system mode settings in response to operation of a laser system.

15. The system of claim 12, wherein, 17. A system for laser catheter treatment in a vessel lumen, comprising:

16. The system of claim 15, wherein, a laser atherectomy system having configurable operating parameters of velocity, fluence, and pulse rate that control an associated laser catheter that outputs a laser from a distal tip; ​ ​ an ultrasound, US, system configured to detect a bubble cloud of carbon dioxide or carbon monoxide generated by the interaction of the laser with the anatomy of the vessel in the treatment region within the vessel lumen and generate a US signal based thereon; a display system configured to present a dynamic display image of the vessel lumen and laser catheter operation; and a control system (108) operatively coupled to the laser atherectomy system, the US system, and the display system, the control system configured by programmable instructions readable on a computer to: receive the US signal; determine a real-time location and measurements of the bubble cloud based on the US signal; estimate a laser catheter dwell location and associated dwell time from the real-time location and the measurements of the bubble cloud; generate a command to modify the laser catheter parameters in response to the estimated dwell location, the estimated dwell time, and a prescribed treatment protocol; and present the command as an alphanumeric message on the display system for viewing by an operator or automatically modify the laser catheter parameters in response to generating the command.

18. The system of claim 17, wherein, the control system is further configured to: determine the location of the bubble cloud by determining an origin (34) near the output of the laser and a range furthest from the output of the laser; identify sub-sections of the bubble cloud having different shapes and, for each sub-section, measure a location, a range, and a corresponding diameter; and periodically store the location of the bubble cloud and the measurements of the sub-sections of the bubble cloud.

19. The system of claim 18, wherein, the control system is further configured to: compare real-time measurements of sub-sections of the bubble cloud to stored measurements of the sub-sections of the bubble cloud to determine a measurement change; and calculate a real-time degree of vessel occlusion from the measurement change.

20. The system of claim 19, wherein, the control system is further programmed to change a US system mode setting in response to activating a laser system.

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