Medical systems and methods of operating medical systems

Abstract

To provide a medical system that can automatically regulate irrigation, suction or both during a lithotripsy procedure.SOLUTION: The system can include one or more sensors. Processing circuitry can be configured to generate an indication of a level of turbidity of a solution at or near a distal tip of a flexible scope, e.g., based on one or more signals from the one or more sensors. A control signal can be used to adjust an irrigation flow rate and / or a suction rate at the distal tip of the flexible scope. The level of turbidity can be determined using a sensor to measure electrolytic conductivity of the solution, a sensor to measure electromagnetic induction across a coil at the distal tip of the flexible scope, and / or a measure of back reflected light or a measure of absorbed light emitted into the solution by a light source and measured by a light sensor.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present disclosure provides a measure of surgical scene clarity, such as during the treatment of kidney stones and other stones during lithotripsy procedures. medical care System and control method relates to.

Background Art

[0002] The treatment of kidney stones and other stones by lithotripsy is a surgical procedure involving on-site observation of the surgical scene of the patient near the target. Observation can be performed using an imaging device, such as a camera attached to a scope such as a ureteroscope, an endoscope, or another similar device. Lithotripsy directs energy, such as ultrasonic energy or laser energy, at the target stone to break the target into smaller fragments, which can then be removed by a perfusion system.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Treating kidney stones can create suspended solids in the solution. This can impair the surgeon's visibility of the surgical scene when viewed through a scope. Therefore, the visual clarity of the surgical scene is at least partially dependent on the amount of suspended solids in the solution.

Means for Solving the Problems

[0004] In this specification, a system and a method for evaluating surgical scene clarity that can be at least partially based on the degree of suspended solids in the solution at the surgical site (e.g., at the distal tip of a scope used in a lithotripsy procedure) are disclosed. For example, the system can provide a measure of surgical scene clarity and use this to provide automatic feedback to the perfusion system of the scope. Existing systems generally use a flexible endoscope including illumination fibers and an imaging system capable of observing the surgical scene. Such a scope can have one or more working channels, including the distal tip of the scope or near it, that can be used to provide functions such as perfusion, suction, grasping, etc. medical care System and control method are disclosed. For example, medical care the system can provide a measure of surgical scene clarity and use this to provide automatic feedback to the perfusion system of the scope. Existing systems generally use a flexible endoscope including illumination fibers and an imaging system capable of observing the surgical scene. Such a scope can have one or more working channels, including the distal tip of the scope or near it, that can be used to provide functions such as perfusion, suction, grasping, etc.

[0005] During lithotripsy, kidney stones and other calculi can be broken into smaller fragments by applying electromagnetic or acoustic energy to the stone. These smaller fragments can be suspended in a solution in or near the surgical scene and then removed by either or both an irrigation and / or aspiration system. Scene visibility may be affected by the degree of fracture, the size and / or number of suspended solids resulting from the stone when it is broken. This specification describes a method for detecting and quantifying a measure of relative clarity (e.g., turbidity) of a solution, known as turbidity, in or near the surgical scene. medical care The system will be disclosed. medical care The system can measure turbidity using sensors on or contained within the medical device. Based on the turbidity, medical care The system can provide one or more of the following to the connected irrigation system: commands, control signals, or feedback. Commands may involve automatically adjusting the settings of the irrigation system, instructing the user to do so, or giving the user an opportunity to confirm whether to perform a recommended command. For example, the irrigation system may be instructed to adjust the irrigation flow rate so that the amount of irrigation solution, such as saline, increases, decreases, or stops. In another example, medical care A system can provide multiple instructions or control signals. For example, medical care The system may, in response to the detected turbidity exceeding a threshold or meeting another specified criterion, stop, or reduce the irrigation, and simultaneously (or substantially simultaneously) start, begin, or increase aspiration. In another example, medical care The system can increase both irrigation and aspiration simultaneously in response to the detected turbidity exceeding a threshold or meeting another specified criterion.

[0006] Therefore, a medical system capable of determining turbidity levels and / or surgical scene clarity can cause the device's irrigation system to adjust the flow rate and / or suction rate of the irrigation solution at the surgical scene (e.g., the distal tip of a flexible endoscope). The determined turbidity level corresponds to a measure of the clarity of the culture medium at the surgical scene, and this can be quantified within a range of possible values. The quantified value can then be passed to or relayed to a processor circuit for comparison with a threshold or one or more other criteria. The obtained information can be used to generate feedback or other control signals that can be communicated to an analog sensor or pump (or pump control), which can then be used to control the amount of irrigation and / or suction or aspiration at the distal tip of the scope. Measurements of high turbidity or low clarity may result in a signal being sent to the irrigation system to increase the flow of the irrigation fluid and / or adjust the corresponding suction rate. Measurements of low turbidity or high clarity may result in a signal being sent to the irrigation system to decrease the flow of the irrigation fluid and / or adjust the corresponding suction rate.

[0007] In one example, a medical system could automatically adjust irrigation and / or aspiration based on turbidity measurements without physician intervention (e.g., automatically). This automatic adjustment could be performed by artificial intelligence (AI), machine learning (ML), or other algorithms (e.g., non-AI or non-ML deterministic algorithms) or processes. Additionally or alternatively, adjustments could be made using hardware-based feedback loops or feedback controls. In another example, an algorithm could output recommendations to a physician for adjusting irrigation and / or aspiration settings, which the physician could then accept or reject.

[0008] Additionally or alternatively, the medical system may determine the turbidity level at different points in time and, if the surgical field is not sufficiently clear (as the procedure progresses), send a signal to the ablation source to reduce or terminate the ablation energy. For example, as a stone is ablated and the turbidity level at the surgical scene or distal tip of the scope increases, the controller circuit may cause a laser, ultrasound transducer, thermal transducer, etc., to stop emitting ablation energy until the scene becomes clear. Additionally or alternatively, the medical system may respond to the increase in turbidity by sending a signal to a light source or radiator to adjust the brightness of the aiming beam or other illumination source.

[0009] Additionally or alternatively, turbidity levels can be used to determine or estimate the time required to complete the procedure. For example, sensors such as particle counters can be incorporated into the medical system and used to determine how much material has been removed from the stone or target scene and / or the rate of ablation, or the rate at which material is removed from the stone or target scene. Based at least in part on this determination, medical care The system can provide a display, such as a graphical user interface (GUI), to physicians or other users. This display may include an estimated time to complete the ablation of the gallstones and / or an estimated time to complete the entire procedure. Such a display or estimate may be particularly useful when the procedure involves ablating multiple gallstones. Additionally or alternatively, the medical system can use sensor data to determine the current turbidity level or turbidity percentage (e.g., how much dust, debris, particles, etc., are currently present in the surgical field) and display that information in the GUI.

[0010] Other examples of displays that a medical system can output to a physician include warnings, error messages, and recommendations. For example, a medical system may provide a display when excessive vibration is detected, for instance, via an accelerometer that may be located at or near the distal tip of the scope. The higher the turbidity level, the more vibration is likely to occur at the tip of the scope, which can negatively impact the procedure. The medical system can also output recommendations to the physician to move, adjust, or reposition the tip of the scope based on the turbidity level. For example, it may recommend moving the tip of the scope to a less turbid area of ​​the surgical field. In another example, instead of automatically adjusting the illumination source or ablation energy as described above, the medical system may recommend that the physician change the settings of the medical device to new values, for example, allowing for user adjustment or confirmation of user adjustment. The new values ​​may include the amount of ablation energy, a new brightness level or brightness percentage of the illumination source, etc.

[0011] Therefore, the medical system may include one or more sensors and processing circuits for measuring or identifying the turbidity level of a solution at or near the distal tip of a flexible endoscope. The turbidity level can be determined using one or more sensors in or coupled to the medical system. For example, a sensor may determine turbidity by measuring electromagnetic induction across a coil at the distal tip of the flexible endoscope. In another example, one or more sensors may include imaging sensors or optical sensors, such as a camera, for collecting imaging information. In such an example, the clarity level of the surgical field can be determined at least in part based on imaging information acquired by the imaging sensor (in conjunction with data collected from other sensors, for example).

[0012] Another sensor may measure the rate at which a substance is broken down or removed from a lithotripsy. In another example, light-emitting diodes (LEDs) may emit light into the solution, and the turbidity level can be determined based on the behavior of the light. For example, one or more sensors may include a sensor for measuring the amount of emitted light (specific turbidity) that is reflected back toward an optical sensor, either contained in or connected to the scope. Additionally or alternatively, one or more sensors may include a sensor for measuring or identifying the amount of emitted light absorbed by the solution (absorbed turbidity).

[0013] The turbidity level or scene clarity can be determined by a processing circuit at least partially based on the correlation of one or more signals from one or more sensors to the turbidity level (e.g., using a correlation function and / or lookup table). Based on the correlation, the processing circuit can provide a signal to the irrigation system of a medical device connected to a flexible endoscope. The signal can control or adjust at least one of i) the irrigation flow rate and / or ii) the suction rate at the distal tip of the flexible endoscope.

[0014] The advantage of automated adjustment of irrigation and / or aspiration, such as based on scene clarity or turbidity, is that the automated adjustment can lead to more efficient and productive lithotripsy procedures. More efficient and productive lithotripsy procedures lead to a reduction in overall procedure time and length. If the turbidity level is not reduced, the lithotomy procedure is less efficient. Therefore, a system that can automatically control irrigation and aspiration to reduce turbidity allows the physician to concentrate on the lithotripsy work, while the system automatically maintains surgical scene clarity. Another advantage of this system is that more fragments can be removed during the procedure because the fragments are removed more efficiently. Therefore, the need for future procedures or follow-up procedures can be reduced or lowered. In addition, data from the sensor and the corresponding turbidity measurements during the procedure can be used to determine the overall efficiency level or score of the procedure. This efficiency score can then be used for subsequent analysis of the procedure, the effectiveness or efficiency of the physician or surgical team, etc.

[0015] In drawings that are not necessarily drawn to scale, similar reference numerals may indicate similar components in different drawings. Similar numerals with different subscripts may represent different examples of similar components. Drawings generally illustrate various embodiments described herein as examples, not limitations. [Brief explanation of the drawing]

[0016] [Figure 1] This figure shows an example of a medical device that can include a turbidity sensor.

[0017] [Figure 2] Figure 1 shows an example of a turbidity sensor that uses electrolytic conductivity, which may be included in medical devices.

[0018] [Figure 3] Figure 1 shows an example of a turbidity sensor that uses electromagnetic induction, which may be included in medical devices.

[0019] [Figure 4] FIG. 1 is a diagram showing an example of a nephelometric turbidity sensor that can be included in a medical device such as the medical device of FIG. 1.

[0020] [Figure 5] FIG. 1 is a diagram showing an example of an absorption turbidity sensor that can be included in a medical device such as the medical device of FIG. 1.

[0021] [Figure 6] FIG. 1 is a diagram showing an example of a cross-section of a fiber tip that can be included at the distal end of a flexible endoscope.

[0022] [Figure 7] FIG. 1 is a diagram showing an example of a control method for determining at least one of turbidity or surgical scene clarity.

[0023] [Figure 8] FIG. 1 is a block diagram of an example of an exemplary apparatus, device, or machine in which any one or more of the techniques (e.g., methodologies) described herein may function.

[0024] [Figure 9] FIG. 1 is a schematic diagram of an exemplary computer-based clinical decision support system (CDSS). DETAILED DESCRIPTION OF THE INVENTION

[0025] The treatment of kidney stones can include breaking the stones into smaller fragments. The resulting smaller fragments can become suspended solids in solution. These suspended solids can then be discharged using a perfusion and / or aspiration system. Scene visibility can be affected by the degree (e.g., size and number) of fragmentation of the suspended solids, and can impair the visibility of the surgeon's surgical scene when viewed through the scope. The inventors have, inter alia, improved medical careThe need for such a system was recognized. The inventors also aim to more efficiently remove suspended solids so that physicians can focus on lithotripsy. medical care We also recognized the need for the system.

[0026] Figure 1 shows an example of a medical device that may include a turbidity sensor. As shown in Figure 1, the medical device may include a device body 100 or a handle and a flexible endoscope 102, such as an endoscope, connected to the device body 100 at its proximal end 112. The medical device may further include an irrigation port 106, an input / output (I / O) connection 108, and an accessory port 110. The flexible endoscope 102 (e.g., the flexible endoscope section) may include a longitudinal working channel inside the flexible endoscope 102. The longitudinal working channel may extend, run, etc., from the proximal end 112 to the distal end 104 or tip and may be used for irrigation and / or aspiration and may include a camera and / or light source (e.g., in fiber or solid).

[0027] The turbidity sensor may be located inside the lumen of the flexible endoscope 102, or outside the flexible endoscope 102 and / or the device body 100. For example, the turbidity sensor may be located in one or more of the following locations: the distal end 104, the irrigation port 106, and / or between the distal end 104 and the irrigation port 106 (such as an internal portion of the device body 100). That is, one or more disclosed (and described later) Turbidity Sensor measurements may be taken or collected at different locations corresponding to the medical device. For example, between the distal end 104 of the flexible endoscope 102 and the irrigation port 106. Turbidity A sensor (e.g., a particle counter) can record the number or amount of suspended elements or particles being discharged. In another example, a particle counter located at or near the distal end 104 can record how many suspended elements or particles are currently present in the solution or medium, for example, at the end of an ablation procedure. The rate or amount of irrigation and / or aspiration can then be determined (or adjusted) based on the number of particles counted by the particle counter.

[0028] The current particle count helps physicians ensure that all fragments from ablated stones are removed before the procedure is complete. Fragments that remain unremoved may be difficult to excrete naturally during urination and could act as potential "seedlings" for the growth of new stones. Furthermore, data from multiple sensors can be combined and used in conjunction with each other. For example, an imaging sensor can be used to identify potentially damaged tissue where new stones may form, allowing physicians to treat it. Therefore, data from particle counters and imaging sensors can be used together to reduce the risk of new stone formation.

[0029] The device input / output circuit can pass one or more sensor signals to a system controller or other controller circuit connected to the medical device via the I / O connection section 108 (which operates the algorithms discussed herein). In lithotomy procedures, one or more Turbidity The sensor can be used in combination with diagnostic or therapeutic energy devices such as ultrasound, thermal, RF, or laser lithotomy systems. For example, the amount of energy emitted from the lithotomy energy device can be controlled or adjusted based on turbidity levels or surgical scene clarity determined from the sensor data.

[0030] Figure 2 shows an example of a turbidity sensor that uses electrolytic conductivity to measure turbidity, which may be contained within a medical device such as the medical device in Figure 1. The electrical conductivity of a solution can be measured by the turbidity sensor between two electrodes (210 and 212) separated by a certain distance, for example. Electrodes 210 and 212 are located in the working channel 214 and / or the irrigation port. 106 or the distal tip of a flexible endoscope or other flexible endoscope. 104 It may be included in or near the distal tip of the scope. 104The electrical conductivity of solution 200 in which the electrodes are located may depend on the ion density (or particle density) of solution 200. A lithotripsy procedure may generate ions 202 or particles suspended in solution 200. Therefore, the conductance per centimeter of solution 200 may be measured using a specified value test or a DC voltage measurement in response to an excitation current, and vice versa. Voltage or current measurements may be obtained by voltage sensors 204 and / or current sensors 206 located in the sensing circuit 208. The measured conductivity response signal may be considered a function of electrode shape and the distance between the two electrodes 210 and 212 and may be correlated with turbidity. The measured conductivity response signal may be used as an index to a correlation function or lookup table that can provide a measure of turbidity.

[0031] Figure 3 shows an example of a turbidity sensor using electromagnetic induction, which may be included in a medical device, such as the medical device in Figure 1. An electromagnetic coupling may be formed between the AC voltage source 300 and the fluid or solution 200. The electromagnetic coupling may be measured by an AC voltmeter 302. The AC voltage source 300 and the AC voltmeter 302 may be components included in the detection circuit 308. The primary coil 304 may be energized by AC power and can induce a current passing through the sample solution 200. This induced current can then induce a measurable voltage in the secondary coil 306, which may be measured by an AC voltmeter 302. The primary coil 304 and / or secondary coil 306 are connected to the working channel 310 and / or irrigation port of a flexible endoscope, such as the flexible endoscope 102 described above. 106 It can be located in this position.

[0032] To provide a measure of turbidity based on the measured voltage, the correlation between the voltage measured in the secondary coil 306 and the turbidity can be determined, for example, using a correlation function or a lookup table. The measure of turbidity may be a function of the coil shape and the spacing between the coils. The AC voltage source 300 and / or AC voltmeter 302 are used by the working channel through the optical fiber (or fiber bundle) inserted into the flexible endoscope 102. 310They can be located at the tip of a fiber inserted into the flexible endoscope 102, such as extending from the flexible endoscope 102 through the distal tip 104 of the flexible endoscope 102, and / or at the irrigation port 106 of a medical device.

[0033] Figure 4 shows an example of a turbidity sensor that may be included in a medical device, such as the medical device in Figure 1. A light source, such as a light-emitting diode (LED) 406, can emit illumination light 400 into the solution 200. In response to the received illumination light, the solution 200 can provide scattered response light 402, which can be detected by a light sensor 404. The degree of back reflection of the response light in response to a given amount of illumination light (e.g., the amount of back-reflected light) can be measured using the light sensor 404. The measured back-reflected light can be converted into an electrical signal. The electrical signal can provide a representation of the turbidity of the solution 200, for example, by using a correlation function, a lookup table, etc.

[0034] The LED 406 and / or light sensor 404 may be fiber-based, for example, by being included in or integrated with an illumination fiber or fiber bundle that can be inserted into the flexible endoscope 102, as shown in Figure 4, which shows a cross-section of the fiber tip 408 at the distal end 104 of the flexible endoscope 102.

[0035] Figure 5 shows an example of an absorption turbidity sensor that may be included in a medical device, such as the medical device in Figure 1. In Figure 5, a light source, such as an LED 500, can be located on the opposite side of the photosensor 502. Between the LED 500 and the photosensor 502, suspended solids (ions 202) in the solution 200 attenuate the synchrotron radiation 504 illuminating the solution 200. The detected portion of the synchrotron radiation 504 can be converted into an electrical signal by the photosensor 502, which can be used to generate a turbidity value via a correlation function, a lookup table, etc. Thus, the absorptivity of the illumination light by the solution 200 can provide a measure of turbidity. Such a configuration is also fiber-based, as similarly described above, and may be included in or integrated with an illumination fiber or fiber bundle.

[0036] Figure 6 shows an example of a cross-section of a fiber tip 600 that may be included in the distal end 104 of the flexible endoscope 102 shown in Figure 1. In one example, the fiber tip 600 may include one or more sensors. One or more sensors may include an optical sensor 602 (e.g., a camera) and / or an environmental sensor 604. The environmental sensor 604 may include a temperature sensor and / or a pressure sensor, or any other sensor capable of detecting or measuring parameters of the environment or medium in which the fiber tip 600 is located. One or more sensors may also include one or more of the turbidity sensors described above for Figures 2 to 5.

[0037] The fiber tip 600 may also include one or more channels, such as a laser channel 606, through which a laser fiber or optical fiber may be inserted or contained, and / or through these fibers, laser radiation, i.e., laser light (visible or invisible), may be emitted. One or more channels may also include a suction channel 608 (working channel). The suction channel 608 may be connected to a pump, vacuum, etc., to allow for the suction or other removal of particles, such as fragmented stones, from the surgical field. The fiber tip 600 may also include an irrigation channel 610. The irrigation channel 610 may be connected to an irrigation system, pump, etc. An irrigation fluid, such as saline, may be pumped or released from the irrigation channel 610 to remove smaller dust particles from the surgical field that are too small to be suctioned through the suction channel 608.

[0038] Figure 7 shows how to determine at least one of turbidity or surgical scene clarity. control An example of Method 700 is shown. control Method 700 may include several operations or steps (702-712) as part of the whole, or complete the whole. These operations are illustrative and are described below. control The method may omit one or more of the listed actions, may repeat actions, may include other actions, or may perform actions simultaneously, substantially simultaneously, or in a different order, as appropriate or as needed. The actions may be performed automatically by a machine or computer processor or controller, as will be discussed later with respect to Figure 8.

[0039] 702, controlMethod 700 may include providing one or more sensors coupled to a flexible endoscope. The flexible endoscope may be an endoscope or other similar scope connected to the handle or body of a medical device. One or more sensors may include environmental sensors such as temperature or pressure sensors, one or more particle counters, or one or more of the turbidity sensors described above for Figures 2 to 5. In 704, control Method 700 may include acquiring signals from one or more sensors, and in 706, may include determining the turbidity level of the solution at or near the distal tip of the flexible endoscope.

[0040] The solution may be the culture medium in which the target, such as a kidney stone, is located (e.g., air, water, saline solution, etc.). Determining the turbidity level can be at least partially based on signals from one or more sensors and at least one of a correlation function or a lookup table. The correlation function and / or lookup table can correlate signals from one or more sensors with the turbidity level and / or surgical scene clarity level. The turbidity level may correspond to the level of turbidity or visibility at the distal tip and may be based on how much of the target has been ablated.

[0041] 708, control Method 700 may include providing a signal to control at least one operating parameter (e.g., to control the amount or flow of irrigation or aspiration at or near the distal tip of the flexible endoscope). For example, if the turbidity level is high (meaning the culture medium contains a large amount of dust and / or particles from the ablated target, resulting in poor visibility of the surgical scene), the irrigation fluid can be pumped through the channel of the flexible endoscope to clarify the surgical scene. Additionally or alternatively, the signal may be sent to a vacuum to aspirate or remove particles through another channel of the flexible endoscope. Or, in another example, the signal may activate or deactivate (e.g., turn on or off) an illumination source, such as a aiming beam, based on a turbidity measurement or level.

[0042] 710, control Method 700 may optionally include acquiring a second signal from one or more sensors and determining a second turbidity level at or near the distal tip of the endoscope. Determining the second turbidity level may be at least partially based on the signals from one or more sensors and at least one of a correlation function or lookup table that correlates the signals from one or more sensors to a turbidity level. The determination made in 710 may be made at a later time than or following the determination made in 706. Thus, the second turbidity level may represent a change in the turbidity level from the determination made in 706.

[0043] 712, control Method 700 may optionally include providing a second signal for adjusting at least one operating parameter (e.g., at least one of aspiration or irrigation at or near the distal tip of the flexible endoscope). The adjustment may be made at least in part on a second turbidity level (or change in turbidity level) determined in 710. For example, if the second turbidity level is higher than the turbidity level determined in 706, the amount of irrigation and / or aspiration may be increased. Conversely, if the second turbidity level is lower than the turbidity level determined in 706, the amount of irrigation and / or aspiration may be reduced or completely terminated. If the signal is used to control an illumination source, when the second turbidity level differs from the turbidity level determined in 706, the intensity or brightness of an illumination source, such as a aiming beam, may be adjusted (e.g., increased, decreased, or terminated) as needed or as appropriate.

[0044] In 708 and / or 712, control signals can be transmitted to the lithotomy light source separately from, or instead of, signals for controlling irrigation and / or aspiration. For example, if the lithotomy light source is a laser, control signals can be transmitted to increase, decrease, or terminate the amount of laser radiation being emitted based on turbidity level, second turbidity level, change in turbidity level, and / or amount (or change) of surgical scene clarity.

[0045] Figure 8 is a block diagram of an example of an apparatus, device, or machine 800 in which one or more of the techniques (e.g., methodologies) described herein may function. In alternative embodiments, machine 800 may operate as a standalone device or be connected to other machines (e.g., network connection). Machine 800 may be connected to the medical device in Figure 1, such as being connected to the medical device via the I / O connection section 108 and / or accessory port 110. In a network-connected deployment, machine 800 may operate as a server machine, a client machine, or both in a server-client network environment. In one example, machine 800 may function as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. Machine 800 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web appliance, network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) specifying the actions to be performed by that machine. Furthermore, although only a single machine is shown, the term “machine” shall also be interpreted to include any set of machines that individually or collectively execute one or more instruction sets to perform any one or more of the methodologies described herein, such as cloud computing, software as a service (SaaS), and other computer cluster configurations.

[0046] Examples may include, or be operated by, logic or several components or mechanisms, as described herein. A circuit set is a collection of circuits implemented in a tangible entity, including hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership may be flexible with respect to time and potential hardware variability. A circuit set includes members that can perform specified operations, either individually or in combination. In one example, the hardware of a circuit set may be designed immutably to perform a particular operation (e.g., hardwiring). In another example, the hardware of a circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.), including a computer-readable medium that is physically modified to encode instructions for a particular operation (e.g., a magnetically, electrically, or mobile arrangement of immutable aggregated particles, etc.). When connecting physical components, the underlying electrical properties of the hardware configuration may be changed, for example, from an insulator to a conductor, or vice versa. Instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create members of a circuit set within the hardware via variable connections to perform specific parts of operation during operation. Thus, computer-readable media are communicatively coupled to other components of the circuit set members while the device is operating. In one example, any one physical component can be used by two or more members of two or more circuit sets. For example, during operation, an execution unit may be used at one point in a first circuit of a first circuit set, and at a different point in time by a second circuit in the first circuit set or a third circuit in the second circuit set.

[0047] The machine (e.g., computer system) 800 may include a hardware processor 802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, a field-programmable gate array (FPGA), or any combination thereof), main memory 804, and static memory 806, some or all of which may communicate with each other via an interlink (e.g., a bus) 830. The machine 800 may further include a display unit 810, an alphanumeric input device 812 (e.g., a keyboard), and a user interface (UI) navigation device 814 (e.g., a mouse). In one example, the display unit 810, the input device 812, and the UI navigation device 814 may be touchscreen displays. Mass storage The machine 800 may further include a drive unit (e.g.) 808, a signal generating device 818 (e.g., a speaker), a network interface device 820 connected to a network 826, and one or more sensors 816 such as a Global Positioning System (GPS) sensor, a compass, an accelerometer, or other sensors. The machine 800 may also include an output controller 828 for communicating with or controlling one or more peripheral devices (e.g., a printer, a card reader, etc.) via a series connection (e.g., Universal Serial Bus (USB)), a parallel connection, or other wired or wireless connection (e.g., infrared (IR), near-field communication (NFC), etc.).

[0048] Mass storage 808 may include a machine-readable medium 822 in which one or more sets of data structures or instructions 824 (e.g., software) that embody or are used by any one or more of the techniques or functions described herein are stored. The instructions 824 may also reside, all or at least partially, in main memory 804, static memory 806, or hardware processor 802 during their execution by machine 800. For example, hardware processor 802, main memory 804, static memory 806, or Mass storageOne or any combination of the 808 elements may constitute a machine-readable medium.

[0049] Although the machine-readable medium 822 is shown as a single medium, the term “machine-readable medium” may include a single or multiple mediums configured to store one or more instructions 824 (e.g., a centralized or distributed database, and / or associated caches and servers). The term “machine-readable medium” may include any non-temporary medium capable of storing, encoding, or carrying instructions for execution by machine 800, causing machine 800 to execute one or more of the techniques of the present disclosure, or storing, encoding, or carrying data structures used by or associated with such instructions. Non-limiting examples of machine-readable mediums may include solid-state memory, as well as optical and magnetic mediums. In one example, the aggregated machine-readable medium includes a machine-readable medium having a plurality of particles having an invariant (e.g., stationary) mass. Thus, the aggregated machine-readable medium is not a transient propagating signal. Specific examples of the collected machine-readable media may include non-volatile memory such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks.

[0050] Figure 9 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 900 that can be configured to implement or recommend modified settings for irrigation and / or aspiration systems based on information regarding the turbidity of the surgical site during a medical procedure. In various embodiments, the CDSS 900 may include an input interface 902 that provides patient-specific information about the patient and / or medical procedures the patient is scheduled to undergo as an input feature to an artificial intelligence (AI) model 904. The input feature may also include a processor, such as a processor 802, which can perform inference operations to apply the information to the AI ​​model to generate one or more modified laser settings, and a user interface (UI) to which one or more modified laser settings are communicated to a user, such as a clinician.

[0051] In some embodiments, the input interface 902 may be a direct data link between the CDSS 900 and one or more medical devices that generate at least some of the input features. For example, the input interface 902 may directly transmit information about a procedure and / or information (e.g., signals) from sensors coupled to a medical device or scope to the CDSS 900 during a therapeutic and / or diagnostic medical procedure. Additionally or alternatively, the input interface 902 may be a classic user interface that facilitates interaction between the user and the CDSS 900. For example, the input interface 902 may facilitate a user interface in which the user can manually input information about a procedure that is specific to the patient. Additionally or alternatively, the input interface 902 may provide the CDSS 900 with access to an electronic patient record from which one or more input features can be extracted. In any of these cases, the input interface 902 may be configured to collect one or more of the following input features in relation to a particular patient at the time the CDSS 900 is used to evaluate the following, or prior to that time:

[0052] Information regarding medical procedures 。

[0053] Information regarding medical devices to be used during treatment 。

[0054] Information regarding one or more settings of an irrigation system for a medical device or an irrigation system connected to a medical device. 。

[0055] Information from one or more sensors, including a measure of the conductance per centimeter of the solution at the surgical site, the electrical conductivity of the solution, or the voltage and / or current described in Figure 2, the voltage of the secondary coil described in Figure 3, the amount of scattered light and / or electrical signal described in Figure 4, the amount of radiant light absorbed by the photosensor described in Figure 5, and the number of particles described in Figure 1. 。

[0056] Information regarding turbidity measure 912 (for example, derived from or based on information from one or more sensors).

[0057] Based on one or more of the above input features, the processor 802 may use the AI ​​model to perform inference operations to generate changes to one or more irrigation settings to be implemented or recommended changes to one or more irrigation settings to be suggested to the user. For example, the input interface 902 may deliver information about the procedure, device, and / or sensor to the input layer of the AI ​​model, which can propagate these input features through the AI ​​model to the output layer. The AI ​​model can provide the computer system with the ability to perform tasks without being explicitly programmed by performing inferences based on patterns discovered in the analysis of the data. The AI ​​model may explore the study and construction of algorithms (e.g., machine learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms may operate by building an AI model from exemplary training data to make data-driven predictions or decisions, which are expressed as outputs or evaluations.

[0058] There are two modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML can use prior knowledge (e.g., correlating inputs to outputs or results) to learn the relationship between inputs and outputs. The goal of supervised ML is to learn a function that best approximates the relationship between training inputs and outputs, given some training data, so that the ML model can implement the same relationship when given inputs to produce the corresponding outputs. Unsupervised ML involves training ML algorithms using information that is neither classified nor labeled, which allows the algorithm to act on that information without guidance. Unsupervised machine learning can be useful for exploratory analysis because it can automatically identify structures within data. Tasks for supervised ML include classification and regression problems. Classification problems, also called categorical classification problems, aim to classify items into one of several categorical values ​​(e.g., is this object an apple or an orange?). Regression algorithms aim to quantify several items (e.g., by providing a score for some input value). Some examples of supervised ML algorithms include logistic regression (LR), naive Bayes, random forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and support vector machines (SVM). Some tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of unsupervised ML algorithms are K-means clustering, principal component analysis, and autoencoders. Another type of ML is federative learning (also known as collaborative learning), which trains algorithms across multiple decentralized devices that hold local data without exchanging data. This approach contrasts with traditional centralized machine learning techniques where all local datasets are uploaded to a single server, as well as more classical decentralized methods that often assume local data samples are uniformly distributed. Federative learning allows multiple parties to build a common, robust machine learning model without sharing data, thus enabling the addressing of critical issues such as data privacy, data security, data access rights, and access to heterogeneous data. In some examples, the AI ​​model can be trained sequentially or periodically before the inference operation is performed by the processor 802. During the inference operation, patient-specific input features provided to the AI ​​model can then be propagated from the input layer, through one or more hidden layers, to the output layer, which ultimately corresponds to changes in one or more of the laser settings. For example, when the turbidity of the surgical field is high, changes in irrigation settings, such as the flow and / or aspiration volume of irrigation fluid, may be propagated to the output layer.During and / or following the inference operation, changes to the irrigation settings are communicated to the user via the user interface (UI) and / or the processor 802 is instructed to automatically adjust the irrigation settings and continue the laser treatment using the new settings.

[0059] Example 1 is a medical system capable of determining at least one of turbidity or surgical scene clarity, the medical system comprising one or more turbidity sensors coupled to a flexible endoscope, and a processing circuit coupled to one or more turbidity sensors, configured to acquire signals from one or more sensors, determine the turbidity level of a solution at or near the distal tip of the flexible endoscope, and provide a signal to control at least one of irrigation, aspiration, or illumination at or near the distal tip of the flexible endoscope based on the determined turbidity level.

[0060] In Example 2, the subject matter of Example 1 is optionally configured such that the processing circuit determines the turbidity level at least in part on signals from one or more turbidity sensors and at least one of a correlation function or lookup table that correlates the signals from one or more turbidity sensors to turbidity levels.

[0061] In Example 3, one or more themes from Examples 1 to 2 optionally include a configuration in which a processing circuit determines a scene clarity level at least in part on signals from one or more turbidity sensors and at least one of a correlation function or lookup table that correlates the signals from one or more turbidity sensors to a scene clarity level.

[0062] In Example 4, one or more subjects from Examples 1 to 3 optionally include a first turbidity sensor among one or more turbidity sensors located inside the lumen or working channel of the flexible endoscope.

[0063] In Example 5, the subject of Example 4 is optionally extended to include the positioning of a second turbidity sensor among one or more turbidity sensors outside the lumen or working channel of the flexible endoscope.

[0064] In Example 6, one or more subjects from Examples 1 to 5 are optionally configured such that one or more turbidity sensors include a first electrode and a second electrode offset laterally from the first electrode, and at least one of the first or second electrode is connected to a detection circuit, the detection circuit comprising at least one of a voltage sensor or a current sensor configured to detect and measure at least one of a voltage signal or a current signal generated between the first electrode and the second electrode.

[0065] In Example 7, the subject of Example 6 optionally includes the positioning of at least one of the first or second electrode inside the lumen or working channel of the flexible endoscope.

[0066] In Example 8, one or more subjects from Examples 1 to 7 are optionally used to include one or more turbidity sensors comprising a first electromagnetic coil coupled to an alternating current (AC) power supply and a second electromagnetic coil coupled to an AC voltmeter, the second electromagnetic coil being offset laterally from the first electromagnetic coil, wherein the AC power supply induces a current in the first electromagnetic coil through a solution between the first and second electromagnetic coils, and the current induces a voltage in the second electromagnetic coil measured by the AC voltmeter.

[0067] In Example 9, one or more subjects from Examples 1 to 8 optionally include a light source that emits light into a solution located at the distal tip of a flexible endoscope, and one or more turbidity sensors include a photosensor configured to measure at least a portion of the emitted light reflected toward the distal tip of the flexible endoscope.

[0068] In Example 10, one or more subjects from Examples 1 to 9 optionally include a light source that emits light into a solution located at the distal tip of a flexible endoscope, and one or more turbidity sensors that are positioned laterally away from the light source and are configured to detect and measure a portion of the emitted light that has been attenuated or absorbed by one or more solids suspended in the solution.

[0069] Example 11 is a medical system capable of determining at least one of turbidity or surgical scene clarity, the medical system comprising a lithotomy light source, one or more turbidity sensors coupled to a flexible endoscope, and a processing circuit coupled to one or more sensors, the processing circuit configured to acquire signals from one or more sensors, determine the turbidity level in proximity to a portion of the solution in the flexible endoscope, and provide a signal to control at least one lithotomy light source or at least one of irrigation, aspiration, or illumination at or near the distal tip of the flexible endoscope, based on the turbidity level.

[0070] In Example 12, the subject matter of Example 11 optionally includes the fact that the lithotripsy light source includes a laser light source, and controlling the lithotripsy light source includes adjusting the intensity or amount of synchrotron radiation, i.e., laser light, emitted from the laser light source.

[0071] In Example 13, one or more themes from Examples 11 to 12 optionally include the fact that the lithotripsy light source includes an acoustic vibration source, and controlling the lithotripsy light source includes adjusting the frequency of the ultrasonic signal emitted by the acoustic vibration source.

[0072] In Example 14, one or more subjects from Examples 11 to 13 are optionally further configured to output at least one of a display or recommendation to a user on a graphical user interface (GUI) communicably coupled to a medical system.

[0073] In Example 15, the subject of Example 14 is optionally extended to include a particle counter in which one or more turbidity sensors are located between the distal tip of the flexible endoscope and an infusion port of a device connected to the flexible endoscope configured to determine the amount of material removed from a target during a lithotomy procedure, the display of which includes at least one of the following: turbidity percentage at or near the distal tip of the flexible endoscope, scene clarity percentage at or near the distal tip of the flexible endoscope, current ablation rate of the target, or estimated time required to complete the ablation of the target.

[0074] Example 16 provides a method for determining at least one of turbidity or surgical scene clarity, the method comprising the steps of: providing one or more turbidity sensors coupled to a flexible endoscope; acquiring signals from one or more turbidity sensors; determining the turbidity level of a solution at or near the distal tip of the flexible endoscope; and providing a signal to control at least one ablation energy or at least one of irrigation, aspiration, or illumination at or near the distal tip of the flexible endoscope, based on the turbidity level.

[0075] In Example 17, the subject matter of Example 16 optionally includes a step of determining the turbidity level that is at least partially based on signals from one or more turbidity sensors and at least one of a correlation function or lookup table that correlates the signals from one or more turbidity sensors to the turbidity level.

[0076] In Example 18, one or more of the themes from Examples 16-17 optionally include determining the surgical scene clarity level based at least partially on the turbidity level.

[0077] In Example 19, the subject matter of Example 18 optionally includes a step of determining the scene clarity level that is at least partially based on signals from one or more turbidity sensors and at least one of a correlation function or lookup table that correlates the signals from one or more turbidity sensors to the scene clarity level.

[0078] In Example 20, one or more subjects from Examples 16 to 19 optionally include providing a control signal to a lithotomy light source coupled to a medical device including a flexible endoscope, at least partially based on the turbidity level.

[0079] The embodiments for carrying out the above invention include references to accompanying drawings that form part of the embodiments for carrying out the invention. The drawings illustrate, as examples, specific embodiments that may be carried out. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those illustrated or described. However, the inventors also intend examples in which only the illustrated or described elements are provided. Furthermore, the inventors also intend examples in which any combination or substitution of the illustrated or described elements (or one or more embodiments thereof) is used, either with respect to a particular example (or one or more embodiments thereof) or with respect to other examples (or one or more embodiments thereof) illustrated or described herein.

[0080] All publications, patents, and patent documents referenced herein are incorporated herein by reference in whole, as if they were individually incorporated by reference. In the event of any inconsistent use between this specification and those documents thus incorporated by reference, the use in the incorporated references should be considered supplementary to the use herein, and the use herein shall govern any inconsistencies.

[0081] In this specification, the terms “a” or “an” are used to include one or more, independently of any other instances or uses of “at least one” or “one or more,” as is common in patent literature. In this specification, the term “or” is used to mean non-exclusive, or, unless otherwise specified, “A or B” is used to mean “A but not B,” “B but not A,” and “A and B.” In the appended claims, the terms “including” and “in which” are used as plain English synonyms for “comprising” and “wherein,” respectively. Also, in the following claims, the terms “including” and “comprising” are open-ended, meaning that any system, device, article, or process that includes elements in addition to those enumerated after such terms in the claims is still considered to be within the scope of those claims. Furthermore, in the following claims, terms such as “first,” “second,” and “third” are used merely as labels and are not intended to impose numerical requirements on those subjects.

[0082] The above description is illustrative and not limiting. For example, the examples (or one or more embodiments thereof) described above may be used in combination with each other. Other embodiments may be used by those skilled in the art, etc., based on the above description. The abstract is submitted with the understanding that it is intended to allow readers to quickly confirm the nature of the technical disclosure and is not to be used to interpret or limit the claims or their meaning. Also, in the forms for carrying out the above invention, various features may be grouped together to streamline the disclosure. This should not be interpreted as meaning that any disclosed feature not claimed is essential to any claim. Rather, the subject matter of the invention may lie in fewer features than all the features of a particular disclosed embodiment. Accordingly, the following claims are incorporated herein into forms for carrying out the invention, and each claim stands alone as a separate embodiment. The scope of the embodiments should be determined with reference to the appended claims, along with the entire scope of equivalents to which such claims are entitled.

Claims

1. One or more turbidity sensors coupled to a flexible mirror, Coupled with the one or more turbidity sensors, A signal is acquired from one or more turbidity sensors. The turbidity level of the solution at or near the distal tip of the flexible endoscope is determined. Based on the determined turbidity level, a signal is provided to control at least one of irrigation, aspiration, or illumination at or near the distal tip of the flexible endoscope. Based on the determined turbidity level, the system estimates the time required to complete the procedure and provides a signal to indicate that time. A medical system comprising a processing circuit configured in such a manner.

2. The medical system according to claim 1, wherein the processing circuit is configured to determine the turbidity level at least in part on the signal from the one or more turbidity sensors and at least one of a correlation function or a lookup table that correlates the signal from the one or more turbidity sensors to the turbidity level.

3. The medical system according to claim 1, wherein the processing circuit is configured to determine the scene clarity level at least in part on the signal from one or more turbidity sensors and at least one of a correlation function or a lookup table that correlates the signal from one or more turbidity sensors to a scene clarity level.

4. The medical system according to claim 1, wherein the first turbidity sensor among the one or more turbidity sensors is located inside the lumen of the flexible endoscope or inside the working channel.

5. The medical system according to claim 4, wherein the second turbidity sensor among the one or more turbidity sensors is located outside the lumen of the flexible endoscope or outside the working channel.

6. The one or more turbidity sensors, The first electrode and A second electrode is offset laterally from the first electrode and Includes, At least one of the first electrode or the second electrode is connected to the detection circuit. The medical system according to claim 1, wherein the detection circuit comprises at least one of a voltage sensor or a current sensor configured to detect and measure at least one of a voltage signal or a current signal generated between the first electrode and the second electrode.

7. The medical system according to claim 6, wherein at least one of the first electrode or the second electrode is located inside the lumen of the flexible endoscope or inside the working channel.

8. The one or more turbidity sensors, A first electromagnetic coil coupled to an AC power supply, A second electromagnetic coil coupled to an AC voltmeter, the second electromagnetic coil being positioned offset laterally from the first electromagnetic coil and Includes, The AC power supply causes the first electromagnetic coil to induce a current passing through the solution between the first electromagnetic coil and the second electromagnetic coil. The medical system according to claim 1, wherein the current induces a voltage measured by the AC voltmeter in the second electromagnetic coil.

9. The flexible endoscope is equipped with a light source that emits light into the solution, The medical system according to claim 1, wherein the one or more turbidity sensors include an optical sensor configured to measure at least a portion of the light emitted from the light source and reflected toward the distal tip of the flexible endoscope.

10. The flexible mirror is equipped with a light source that emits light into the solution located at the distal tip of the flexible mirror, The medical system according to claim 1, wherein the one or more turbidity sensors include a light sensor positioned laterally from the light source and configured to detect and measure a portion of the light emitted from the light source and attenuated or absorbed by one or more solids suspended in the solution.

11. A method for operating a medical system comprising one or more turbidity sensors coupled to a flexible endoscope and a processing circuit coupled to the one or more turbidity sensors, The aforementioned processing circuit A signal is acquired from one or more turbidity sensors. The turbidity level of the solution at or near the distal tip of the flexible endoscope is determined. Based on the determined turbidity level, a signal is provided to control at least one of irrigation, aspiration, or illumination at or near the distal tip of the flexible endoscope. A method for operating a medical system, which estimates the time required to complete a procedure based on the determined turbidity level and provides a signal to indicate the time.

Images