Active temperature control system for anatomical site

Abstract

To provide an irrigation system, device, method, control system, etc. capable of setting an anatomical temperature for an object that is automatically managed.SOLUTION: There are provided a system, a device, and a method for managing a temperature and a pressure of an anatomical site. The system includes: a scope configured to provide a view of the anatomical site; an energy transmission device configured to transmit treatment energy to the anatomical site; a first irrigation conduit configured to transfer fluid to the anatomical site; a first temperature sensor arranged to provide first temperature data related to the anatomical site; and a control circuit electrically joined to receive the first temperature data, the control circuit being configured to adjust, based at least in part on the first temperature data, at least one of (i) a first temperature of the fluid, (ii) flow volume parameters of the fluid, and (iii) settings of the energy transmission device for managing a second temperature of the anatomical site.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 131,221, entitled "Active Cooling Irrigation System for Anatomic Sites," filed December 28, 2020, which is incorporated herein by reference in its entirety.

[0002] These teachings relate to temperature control of fluids for irrigation of anatomical sites. [Background technology]

[0003] Endoscopic, arthroscopic, lithotripsy, and other procedures using a scope typically include irrigation to remove fluid from the body to clear the scope's view. Examples of bodily fluids include urine and blood. Fluids scatter light and can obscure the image provided by the scope. Scattered light makes it more difficult for the physician to clearly see the target anatomical structure (sometimes called the "anatomical site"). The flow rate of the irrigation fluid can be set high enough to keep fluid out of the endoscopic field of view. This involves delivering pressurized fluid to the scope at the anatomical site. Such treatments include lasers, electrical current, etc. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Publication No. 2018 / 0055568 Summary of the Invention [Means for solving the problem]

[0005] The teachings herein provide temperature control of an anatomical site. The teachings provide irrigation systems, devices, methods, control systems, etc. that may enable a physician to set an automatically managed target anatomical temperature. The system can maintain temperature by monitoring one or more temperature sensor measurements, one or more flow rate measurements, and / or therapy delivery output settings. The system can observe or measure the rise and fall of temperature during therapy delivery at a particular setting, irrigation temperature, and flow rate. The system can use the observations or measurements to calculate the cooling power of the anatomical site, i.e., the fluid flow rate and temperature required to maintain the desired anatomical temperature. Various fluid temperatures can be achieved by mixing refrigerated fluid with room temperature fluid or even heated fluid.

[0006] The therapy delivery device may include, or may be coupled to, a scope configured to provide a view of the anatomical site. The system may include an energy delivery device configured to deliver optical or electrical energy to the anatomical site. A first irrigation conduit may be disposed to transport fluid from a fluid reservoir to the anatomical site. A first temperature sensor may be disposed to provide first temperature data associated with the anatomical site. A control circuit may be electrically coupled to receive the first temperature data. The control circuit may be configured to adjust at least one of (i) a first temperature of the fluid, (ii) a flow rate parameter of the fluid, or (iii) a setting of the energy delivery device to manage a second temperature of the anatomical site based on the first temperature data.

[0007] The system may include a suction device configured to remove fluid from the anatomical site and provide the removed fluid. A second conduit may be in fluid communication with the suction device to receive the removed fluid and configured to transport the removed fluid from the anatomical site. The first temperature data may include a third temperature of the removed fluid. The first temperature data may include a second temperature.

[0008] The system may include a fluid cooler in fluid communication with the fluid. The fluid cooler may be configured to receive and cool a first portion of the fluid to provide a cooled fluid. The control circuit may adjust a fourth temperature to which the fluid cooler cools the cooled fluid based on the first temperature data. A third conduit may be in fluid communication with the fluid. The third conduit may be configured to receive a second portion of the fluid. The first conduit may be configured to receive a mixture of both the second portion of the fluid and the cooled fluid.

[0009] The system may include a fluid heater in fluid communication with the fluid. The fluid heater may be configured to receive and heat a third portion of the fluid to provide a heated fluid. The first conduit may be configured to receive a mixture of both the heated and cooled fluids.

[0010] An actuated valve may be in fluid communication with the first conduit and electrically coupled to the control circuit. The actuated valve may be disposed between the fluid cooler and the first conduit or between the fluid heater and the first conduit. The control circuit may be configured to change a physical state of the actuated valve based on the first temperature data.

[0011] A second temperature sensor may be positioned to determine a fifth temperature of the fluid from the actuated valve. The control circuit may be further configured to adjust respective temperature settings of the fluid heater and the fluid cooler based on the fifth temperature. The system may include a pump in fluid communication with the first conduit. The pump may be electrically coupled to the control circuit. The control circuit may be configured to adjust a pumping speed of the pump based on the first temperature data.

[0012] The pressure sensor may be electrically coupled to the control circuit and positioned to generate pressure data representative of the pressure surrounding the anatomical site. The control circuit may be further configured to adjust a pumping speed of the pump based on the pressure data. A flow sensor may be positioned to determine a flow rate of fluid from the pump. The flow sensor may be electrically coupled to the control circuit. The control circuit may be further configured to adjust a speed of the pump based on the flow rate.

[0013] The control circuitry may be configured to adjust settings of the energy delivery device to manage the temperature of the anatomical site based on the first temperature data. A display device may be electrically coupled to the control circuitry. The display device may be configured to provide a view of the first temperature to a user. The user interface may be configured to receive data indicating a first temperature setpoint above which to maintain the anatomical site and a second temperature setpoint below which to maintain the anatomical site. The control circuitry may operate to manage the temperature of the anatomical site between the first temperature setpoint and the second temperature setpoint.

[0014] The drawings are not necessarily drawn to scale, and like numerals in different figures may represent like components. Like numerals with different letter suffixes may represent different instances of like components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. [Brief explanation of the drawings]

[0015] [Figure 1A] FIG. 1 illustrates, by way of example, a system for managing fluid temperature of fluid provided to an anatomical site. [Figure 1B] FIG. 1 illustrates another system for managing fluid temperature of fluid provided to an anatomical site, by way of example. [Figure 2] FIG. 1 is a block diagram illustrating another system for managing fluid temperature of fluid provided to an anatomical site, by way of example. [Figure 3] FIG. 1 is a block diagram illustrating another system for managing fluid temperature of fluid provided to an anatomical site, by way of example. [Figure 4] FIG. 1 is a block diagram illustrating a system for managing fluid temperature of a mixed fluid provided to an anatomical site, as an example. [Figure 5] FIG. 1 is a block diagram illustrating a system for managing fluid temperature of a mixed fluid provided to an anatomical site, as an example. [Figure 6] 1 illustrates, by way of example, an embodiment of a method for temperature management of an anatomical site. [Figure 7] 1 is a flow diagram illustrating a method for determining temperature, pressure, or a combination thereof at an anatomical site, by way of example. [Figure 8] As an example, a diagram illustrating a method for adjusting one or more components of the system of Figure 1A, Figure 1B, Figure 2, Figure 3, Figure 4, or Figure 5 to regulate the temperature of an anatomical site. [Figure 9] 1A, 1B, 2, 3, 4, or 5 to adjust pressure at an anatomical site. [Figure 10] As an example, a block diagram of one embodiment of a machine (eg, a computer system) for implementing one or more embodiments is shown. DETAILED DESCRIPTION OF THE INVENTION

[0016] Endoscopic, arthroscopic, lithotripsy, and other scope-based procedures may include irrigation to remove fluid from the body to clear the scope's view. In these limited procedures, this irrigation fluid is room temperature or heated saline. In addition to maintaining a clear view, fluid may also be used to cool the anatomical site. This cooling helps control the temperature of the anatomical site if the treatment being performed heats it (and the surrounding anatomical structures and fluids). Such treatments may include lasers, electrical currents, etc. Rapidly delivering too much fluid to an anatomical site can, in extreme cases, cause hypothermia, such as in highly vascular organs like the kidney. Delivering too little fluid to an anatomical site can lead to tissue overheating and tissue damage. Furthermore, delivering fluid too slowly can create the risk of the fluid becoming too hot for an extended period of time. Therefore, the fluid flow rate and starting temperature, the duration of the treatment, or a combination of these must be carefully considered during the procedure to avoid or at least mitigate the risk of hypothermia and overheating of healthy tissue.

[0017] To mitigate temperature issues, clinicians can use irrigation systems that actively heat or cool fluids. Body temperature fluids provide less cooling than cooler, actively cooled fluids. Anatomical areas with elevated temperatures due to treatments such as laser lithotripsy can benefit from cooler than body temperature fluids.

[0018] Proteins can begin to denature at approximately 42°C. It may be undesirable for anatomical structures not targeted for intervention to reach this temperature. If fluids are used at body temperature, interventions will raise the local anatomical temperature by only about 5°C before reaching this limit.

[0019] When using room-temperature irrigation fluids (typically 18°C-25°C), therapeutic interventions can only increase local anatomical temperatures by 17°C-24°C before reaching the same temperature limit of 42°C. Assuming the same average power output of the treatment energy source (e.g., laser control system, power supply, generator, etc., powering one or more lasers or electrodes), treatment can proceed 3-5 times longer using "room-temperature fluids" compared to body-temperature fluids (assuming a linear relationship exists when using room-temperature irrigation instead of body-temperature irrigation). For interventions where the treatment is an energy device, such as a laser or electrosurgical system, actively cooled irrigation can adequately accommodate prolonged treatment at lower anatomical temperatures.

[0020] In the case of laser lithotripsy, the heating power of the treatment increases the anatomical temperature. The treatment power quickly overheats even when using room-temperature fluid. To extend the continuous treatment time using laser lithotripsy, a chilled fluid source can be used. Increasing the continuous treatment time reduces the wait time for the target site to cool, shortening the overall procedure time. Longer treatment times may allow physicians to use laser lithotripsy to break up kidney stones, for example, into sufficiently small pieces without worrying about damaging the patient's tissue. Increased treatment times may allow physicians to continue removing diseased tissue using monopolar or bipolar electrodes. As used herein, chilled fluid refers to a fluid that is actively cooled beyond ambient cooling, whereas room-temperature fluid (sometimes referred to as "direct fluid") is not actively cooled but is cooled only by ambient temperature. Active cooling refers to the use of electricity, gas, or any suitable cooling technology to reduce the temperature of a fluid more quickly than by leaving the fluid in a room and waiting for it to cool. Chilled fluid from the cooling fluid source can extend treatment duration beyond that currently possible using direct fluid, while maintaining the average temperature of anatomical fluids near the treatment area below 42°C and above hypothermic levels.

[0021] The teachings herein provide for the selective delivery of refrigerated (sometimes referred to as "cooled"), heated, direct (fluid not actively heated or cooled), or a combination thereof, irrigation fluid to an anatomical site. For example, if the anatomical temperature rises above a user-programmable threshold (e.g., 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45°C, or higher or lower), cooled fluid can be provided to the anatomical site through a scope, a conduit coupled to or used with the scope, or the like. The cooled fluid can be as cold as 4°C, but can also be warmer. In some configurations, the cooling rate of the cooled fluid can be greater than the corresponding warming rate of room temperature or warmer fluid, slowing or reversing the temperature rise at the anatomical site. When the temperature measured at an anatomical site begins to stabilize or drop below a threshold (e.g., 32, 31, 30, 29, 28°C, or higher or lower temperatures), the irrigation system can be configured (e.g., automatically) to deliver (e.g., more) direct fluid, heated fluid, or a combination thereof. The increase in direct or heated fluid warms the anatomical site and can cause a corresponding increase in the temperature at the anatomical site. Hypothermia requires the core body temperature to drop below 35°C. This is not the same as measuring 35°C at the treatment site, as this temperature difference is only 2°C below body temperature. The risk of hypothermia is indicated by a specified time below the temperature threshold. The time at a specified temperature can be used to estimate the core body temperature.

[0022] The teachings provide irrigation systems, devices, methods, control systems, etc. that may enable a physician to set an automatically managed target anatomical temperature. The system can maintain temperature by monitoring temperature sensor readings, pressure sensor readings, flow rate readings, and / or therapy delivery device settings. The system can measure and / or calculate the temperature rise and fall resulting from administering therapy for a certain duration at a particular setting, irrigation temperature, and flow rate, and use the measurements / calculations to determine the cooling rate (e.g., degrees per unit time) of the anatomical site and, therefore, the fluid flow rate and temperature required to achieve or maintain the desired anatomical temperature. The cooling rate is the amount of temperature decrease per unit time. The warming rate is the amount of temperature increase per unit time. Both the cooling rate and warming rate are examples of more general rates of temperature change. Various fluid temperatures can be achieved by mixing refrigerated fluid with room temperature or heated fluid.

[0023] FIG. 1A shows, by way of example, a diagram of a system 100A for managing the fluid temperature of a fluid provided to an anatomical site 114. The illustrated system 100A includes a fluid reservoir 102 in fluid communication with the anatomical site 114. A conduit 134 is in fluid communication with the reservoir 102 and the anatomical site 114. The conduit 134 receives fluid from the reservoir 102 and transports the fluid to the anatomical site 114. An energy delivery scope (e.g., an endoscope) 120 is in proximity to or in contact with the anatomical site 114 for treatment. The scope 120 receives energy from an energy delivery device (e.g., a laser device, an ultrasound device, or an electrical device) 118 via a communication medium (e.g., an optical fiber, an electrical conductor, or a wireless communication medium) 136. The energy provided by the energy delivery device 118 is controlled by an energy control system (e.g., a laser energy generator, an electrical energy generator, an ultrasound energy generator, etc.) 116. In one embodiment, a temperature sensor 138 is positioned in or around the anatomical location 114. Additionally or alternatively, the temperature sensor 138 can be positioned to measure fluid flowing into or out of the anatomical location 114. The temperature sensor 138 provides temperature data to a control circuit 142 via an electrical communication medium 140. The control circuit 142 manages the temperature of the anatomical location 114 by adjusting one or more parameters related to fluid delivery (e.g., temperature and / or flow rate), operating parameters of the energy control system 116 (e.g., power, magnitude, frequency, voltage, current, duty cycle, energy level, etc.), etc.

[0024] The fluid reservoir 102 may include a faucet, a bag, a tank, a bucket, etc. The fluid from the fluid reservoir 102 (or another reservoir) may include saline or another fluid. The fluid may flow from the fluid reservoir 102 into the conduit 134 by gravity, titration by a valve, or a combination thereof.

[0025] The conduit 134 is a hollow tube. A first end of the conduit 134 is mechanically coupled to the reservoir 102 and can receive fluid from the reservoir 102. An opposite second end of the conduit 134 can be located near the anatomical site 114. The conduit 134 can travel through the scope 120 or can be permanently attached or removably coupled to the scope 120. The conduit 134 transports fluid to the anatomical site 114 while protecting the fluid from the environment surrounding the conduit 134.

[0026] The scope 120 includes optical components (e.g., lenses, mirrors, collimators, filters, prisms, polarizers, beam splitters, wave plates, optical fibers, cameras, etc.) configured to provide an image of the anatomical site 114. The scope 120 may include a communication medium (e.g., optical fiber, electrical conductors, or wireless communication medium) 136 permanently or removably attached thereto. A physician or other user can view the anatomical site 114 through the optics on the scope 120 or through a display 224 (see FIG. 2 ). The physician or other user can enable, disable, or adjust the treatment provided by the energy delivery device 118 using control knobs, buttons, or, for example, foot-activated control pedals and / or other actuation mechanisms on or coupled to the scope 120. Additionally or alternatively, the physician can control the energy delivery device 118 via a separate control system (e.g., a laser console touchscreen display). The procedure of viewing inside a patient's body is called endoscopy. The scope 120 may be used to examine internal organs such as the throat, sinuses, ureters, kidneys, and esophagus. Endoscopes may be specialized for viewing target organs. These specialized endoscopes are sometimes named after the organs they serve. For example, a sinusoscope is specialized for providing a view of the sinuses, an otoscope is specialized for providing a view of the inner ear, a ureteroscope is specialized for providing a view of the ureters, a laryngoscope is specialized for providing a view of the larynx, a cystoscope is specialized for providing a view of the bladder, a nephroscope is specialized for viewing the kidneys, a bronchoscope is specialized for viewing the bronchi, an arthroscope is specialized for viewing the joints, a colonoscope is specialized for viewing the colon, and a laparoscope is specialized for viewing the abdomen or pelvis.

[0027] The energy delivery device 118 may include a laser, a power source, etc. The communication medium 136 may include an optical fiber (if the treatment device 118 includes a laser), an electrical conductor that can be coupled to a monopolar or bipolar electrode (if the treatment device 118 includes a power source), etc. The treatment device 118 may generate energy that is transmitted to the anatomical location 114 by the communication medium 136. The energy control system 116 may adjust the energy delivery device 118 to regulate the energy provided to the anatomical location 114 by the energy delivery device 118 and the communication medium 136. The energy control system 116 may adjust operating parameters of the energy delivery device 118. Examples of operating parameters include the intensity, frequency, duration, or other parameters of laser treatment. Examples of other operating parameters include the magnitude, amplitude, frequency, shape, or other parameters of electrical treatment. Examples of energy control systems 116 include laser generators, power generators, ultrasound generators, etc. These generators typically include user-operable knobs, touchscreens, buttons, etc. A user can adjust the generator's output parameters by providing input via a touchscreen, pressing a button, turning a knob, etc. The energy control system 116 includes an input interface that can adjust the operating parameters. The input interface is electrically coupled to the energy generation circuit (or a controller for the energy generation circuit). The input interface adjusts the energy generation circuit in response to input received at the input interface or provides input (in the same format as or a different format than that received) to the controller so that the controller can adjust the energy generation circuit in response to the input. The input can be provided by a user (turning a knob, touching a touchscreen, etc.), the control circuit 142, a user-controlled device (e.g., the scope 120, a foot pedal coupled to the scope 120, etc.), or a combination thereof.

[0028] The temperature sensor 138 determines a temperature or otherwise provides data that can be used to determine the temperature of the anatomical site 114. The temperature sensor 138 may include an infrared (IR) sensor, a thermocouple, a resistance temperature detector (RTD), a thermistor, a semiconductor-based integrated circuit (IC), or the like. The temperature sensor 138 may be integrally formed with the scope 120, physically separate from the scope 120, attached to the scope 120, removably coupled to the scope 120, or the like. If the energy delivery device 118 is a laser, the IR-based temperature sensor may be turned off while laser energy is delivered to the anatomical site 114. Temperature data from the temperature sensor 138 may be provided to the control circuitry 142 by the communication medium 140. The temperature data may be indicative of a temperature associated with the anatomical site 114. For example, the scope 120 may include or be coupled to an IR-sensitive fiber optic channel that can transmit light back to an IR thermometer to measure the temperature data. To avoid collisions with the laser output radiation, the thermal measurement may be turned on when the laser or other energy radiation is off.

[0029] Control circuitry 142 includes electrical or electronic components configured to provide control signals to the energy control system via communication medium 146 or to the fluid delivery system via communication medium 144. The electrical or electronic components may include one or more transistors, resistors, capacitors, diodes, inductors, oscillators, memory devices, amplifiers, analog-to-digital converters, digital-to-analog converters, multiplexers, switches, logic gates (e.g., AND, OR, XOR, negate, buffers, etc.), power supplies, processing devices (e.g., central processing units (CPUs), graphics processing units (GPUs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), etc.), etc.

[0030] The control circuitry 142 can reduce the power provided by the energy control system 116 if the temperature data meets a first criterion. The control circuitry 142 can communicate with the energy control system 116 via a communication medium 146 (e.g., a wired or wireless communication medium). The control circuitry 142 can provide control signals to the energy control system 116 that adjust energy delivery parameters of the energy generated by the energy control system 116.

[0031] The control circuit 142 can increase the flow rate of fluid from the fluid reservoir 102 if the temperature data meets a first criterion or a second, different criterion. The first criterion includes the temperature indicated by the temperature data being equal to or greater than a threshold temperature (e.g., a user-specified temperature or a default temperature). The second criterion may include the same or a different temperature threshold.

[0032] The control circuitry 142 can increase the power provided by the energy control system 116 if the temperature data meets a third criterion. The control circuitry 142 can decrease the flow rate of fluid from the fluid reservoir 102 if the temperature data meets the third criterion or a fourth, different criterion. The third criterion can include the temperature indicated by the temperature data being at or below a threshold temperature (e.g., a user-specified or default temperature). The fourth criterion can include the same or a different temperature threshold. Any of the threshold temperatures can be set based on a safe operating temperature of the energy delivery device 118 and, in one embodiment, can be set by the user. One or more of the threshold temperatures can be set to help ensure that the temperature of the tissue surrounding the anatomical site 114 does not reach 42°C. Such threshold temperatures can include temperatures above or below 34°C, 35°C, 36°C, 37, 38, 39, 40, 41, 42, 43, 44, 45°C, or temperatures below 42°C. One or more of the threshold temperatures may be set to help ensure that the temperature of the tissue surrounding the anatomical site 114 is maintained above a temperature corresponding to hypothermia, which occurs when the body temperature falls below 35° C. The lower threshold temperature may be approximately 32, 31, 30, 29, 28° C., such as to help ensure that hypothermia does not occur during the duration of energy delivery.

[0033] The communication media 136, 140, 144, 146 (or other communication media herein, such as in Figures 2, 3, 4, and 5) can include wired, wireless, or optical communication mechanisms. Wired communication media include conductors such as traces, wires, etc. Wireless communication media include a transmitting antenna that transmits electromagnetic transmissions to a receiving antenna. The electromagnetic transmissions may conform to a communication protocol that defines how data is encoded on the electromagnetic transmission. Examples of wireless communication protocols include Bluetooth, Zigbee, WiFi, radio frequency identification (RFID), cellular, near field communication (NFC), etc. Optical communication media include optical fibers, outdoor space, etc., through which light can pass in a limited manner.

[0034] 1B shows, by way of example, a diagram of another system 100B for providing temperature control at an anatomical site. System 100B is similar to system 100A, except that system 100B includes an additional pressure sensor 150 and flow sensor 148.

[0035] The flow sensor 150 may be on or at least partially within the suction device 330 (see FIG. 3), the conduit 332, or the conduit 134. The flow sensor 336 may provide flow data to the control circuit 142 via the communication medium 152. The flow data may indicate how quickly fluid and debris are being removed from the anatomical site 114 or how much fluid is being provided to the anatomical site 114 per unit time.

[0036] The pressure sensor 150 can provide pressure data to the control circuitry 142 via the communication medium 154. The pressure data can indicate fluid pressure near the anatomical location 114 and / or pressure against tissue at the anatomical location 114. The pressure sensor 150 can be integrally formed with the scope 120, removably coupled to the scope 120, attached to the scope 120, or physically separate from the scope 120. The pressure at the anatomical location 114 can indicate how much gas is being retained due to fluid evaporation, how much fluid and debris has accumulated within the anatomical location 114, the temperature associated with the anatomical location 114, or a combination thereof. The pressure at the anatomical location 114 can affect the efficiency of energy delivered to the anatomical location 114. By controlling the pressure, the control circuitry 142 can help ensure that energy delivery is effective and safe.

[0037] The control circuit 142 can determine a temperature associated with the anatomical site 114 based on temperature data from the temperature sensor 138, flow rate data from the flow sensor 150, pressure data from the pressure sensor 150, and / or any combination thereof. The control circuit 142 can increase the flow rate of the fluid in the conduit 134, such as to alter the temperature of the anatomical site 114. The control circuit 142 can alter a temperature setpoint of the fluid in the fluid reservoir 102 based on temperature data from the temperature sensor 138, flow rate data from the flow sensor 148, pressure data from the pressure sensor 150, and / or any combination thereof.

[0038] Although Figures 1A and 1B show a temperature sensor 138, a flow sensor 148 and / or a pressure sensor 150 may be used at or near the target anatomical site, or the temperature sensor 138, flow sensor 148 and / or pressure sensor 150 may be used at one or more sites not proximate to the target anatomical site (e.g., on the proximal end of the scope 120).

[0039] Systems 100A, 100B assist users of scope 120 in maintaining the temperature of anatomical site 114 (and the anatomical structures surrounding anatomical site 114) below denaturation temperatures and / or above hypothermia-inducing temperatures. Systems 100A, 100B improve upon conventional irrigation systems that do not include feedback of temperature, pressure, or flow data to inform temperature management. Systems 100A, 100B can selectively, adaptively, and intelligently adjust the temperature of the target site based on measured / calculated temperature, flow, pressure, or a combination thereof.

[0040] 2 shows, by way of example, a block diagram of another system 200 for managing fluid temperature of fluid from a fluid reservoir 102 provided to an anatomical site 114. System 200 includes several components of systems 100A, 100B, including fluid reservoir 102, conduit 134, endoscope 120, energy control system 116, energy delivery device 118, temperature sensor 138, control circuitry 142, and communication media 136, 140, and 146. System 200 includes additional components, including a fluid cooler 228, a display device 224, and communication media 220, 222.

[0041] The conduit 230 provides a path for the fluid to flow to the fluid cooler 228. The fluid cooler 228 reduces the temperature of the fluid. The fluid cooler 228 can operate by evaporating the coolant (e.g., changing the coolant from a liquid state to a gaseous state), thereby cooling the area surrounding the coolant. The fluid cooler 228 can operate based on the Peltier effect. Such coolers transfer heat from a first portion of an object to a second object or a second portion of the same object, thereby cooling the first portion of the object. This cools the fluid in contact with the first portion of the object and the surrounding fluid. There are other types of cooling that can be used with these teachings, and the cooling types provided are merely examples.

[0042] A mechanical coupling between the conduit 134 and the fluid cooler 228 may hold the first end of the conduit 134 around the port of the fluid cooler 228. The mechanical coupling may include a form fit, a compression ring, or other mechanical coupling.

[0043] The control circuit 142 can provide a control signal to the fluid cooler 228 over the communication medium 220. The control signal can cause the fluid cooler 228 to adjust the temperature to which the fluid cooler 228 cools the fluid. If the temperature data over the communication medium 140 indicates that the temperature has met the third or fourth criterion, the control signal can cause the temperature setpoint of the fluid cooler 228 to be increased (or the cooling of the fluid cooler 228 to be turned off). If the temperature data over the communication medium 140 indicates that the temperature has met the first or second criterion, the control signal can cause the temperature setpoint of the fluid cooler 228 to be decreased.

[0044] The control circuitry 142 may provide display temperature data over the communication medium 222. The display temperature data may be provided to the display device 224. The display temperature data may include a measured or calculated temperature at the anatomical site 114, such as using the temperature sensor 138. The display temperature data may include other data related to the temperature of the anatomical site 114, such as a temperature set point for the fluid cooler 228, power or other energy delivery parameters of the energy control system.

[0045] The display device 224 may include a touch screen, a light-emitting diode screen, a liquid crystal display screen, or other types of displays. The display device 224 may provide displayed temperature data on a user interface 226. The user interface 226 provides a user with a real-time (or near real-time) view of the displayed temperature data. The user interface 226 may include an application programming interface (API) that allows a user to provide system control parameters that govern the operation of the control circuitry 142. The system control parameters may include temperature thresholds (high temperature threshold, low temperature threshold, or both), the maximum amount of power provided by the energy delivery device 118 via the energy control system 116, electrical or optical energy parameters of the energy provided by the energy control system 116, temperature set points of the fluid cooler 228, combinations thereof, etc. The control parameters provided via the user interface 226 may be implemented by the control circuitry 142.

[0046] If the temperature data, pressure data, flow data, or a combination thereof indicates that the temperature, pressure, or combination thereof at the anatomical site 114 is approaching, equaling, or meeting a criterion, the user interface 226 can provide a warning to the user. The warning can be displayed visually using the interface 226. For example, the visual warning can include a photo, video, text, or a combination thereof. In one embodiment, the user interface 226 continuously displays the temperature reading / estimate in some neutral color (e.g., white) if the measured / calculated temperature at the anatomical site 114 is below a predetermined threshold. If the measured / calculated temperature at the anatomical site 114 exceeds the threshold, the color of the numbers may change to red and / or bold. Additionally or alternatively, audio, tactile feedback, or other warnings can be used to indicate that the temperature data, pressure data, flow data, or a combination thereof indicates that the temperature, pressure, or combination thereof is approaching, equaling, or other specified criterion has been met. The display of temperature data, pressure data, flow rate data, or a combination thereof, allows a user to manually adjust the fluid cooler 228 (e.g., to adjust the temperature of the fluid), the fluid reservoir 102 (e.g., to adjust the flow rate of the fluid), or the energy control system 116 (e.g., to adjust the rate of temperature change of the energy provided to the anatomical site 114) to successfully maintain the temperature of the anatomical site 114 within predetermined limits. The user interface 226 can provide visual, audio, tactile feedback, etc. of proposed adjustments that, if accepted by the user via the user interface 226, are automatically implemented by the control circuitry 142. In some embodiments, the control circuitry 142 can automatically implement the proposed adjustments after a specified time has elapsed or without any delay. The user can define tolerances within which the system 200 (or other systems) can make automatic adjustments to the energy control system 116, the fluid reservoir 102, or the fluid cooler 228.For example, a user may enable the system 200 to automatically adjust the energy control system 116 to deliver a maximum of 20 W of energy, a 20 Hz pulse frequency, and 150 mm of water pressure, such as to attempt to maintain the temperature surrounding the anatomical site 114 below 42° C. These approved system operating ranges are user-configurable, thereby reducing the frequency with which a user must respond to system alerts and suggestions during patient treatment.

[0047] The system 200 provides enhanced cooling control, such as when the energy delivery device 118 delivers energy at a rate that causes a temperature change that cannot be managed with uncooled fluid. The system 200 can allow a user to operate the energy delivery device 118 at the anatomical site 114 for a longer duration than would be possible without actively cooling the fluid. Using room temperature fluid, or other fluids whose temperature is not actively managed, reduces the precision of control over the temperature of the anatomical site 114. By using the fluid cooler 228, a user can operate the energy delivery device 118 for a longer period of time without raising the temperature above the denaturation temperature that room temperature fluid would accommodate. This allows a user to provide treatment more continuously without having to pause and wait for the temperature of the anatomical site 114 and its surroundings to drop to a temperature that does not endanger the tissue surrounding the anatomical site 114.

[0048] 3 shows, by way of example, a block diagram of another system 300 for managing fluid temperature of fluid provided to an anatomical site 114. System 300 includes several components of systems 100A, 100B, or 200, including fluid reservoir 102, conduit 134, scope 120, energy control system 116, energy delivery device 118, temperature sensor 138, control circuitry 142, display device 224, fluid cooler 228, and communication media 136, 140, 146, 220, 222. System 300 includes additional components, including a suction device 330, a flow sensor 336, a temperature sensor 338, a waste container 334, a second conduit 332, and communication media 340 and 342.

[0049] Suction device 330 removes fluids and debris from anatomical site 114. Suction device 330 can generate negative air pressure that forces fluids and debris through conduit 332 and into waste container 334. Suction device 330 can be integrally formed with scope 120, physically separate from scope 120, attached to scope 120, removably coupled to scope 120, etc. Suction device 330 helps remove warm fluids and debris from anatomical site 114, thus helping to maintain the ambient temperature of anatomical site 114.

[0050] A conduit 332 may extend between the suction device 330 and a waste container. The conduit 332 may transport fluids and debris from the anatomical site 114 to the waste container 334. The conduit 332 and the conduit 134 may be different portions of the same conduit or may be separate conduits.

[0051] The temperature sensor 338 may be on or at least partially within the suction device 330 or the conduit 332. The temperature sensor 338 can provide temperature data to the control circuitry 142 via a communication medium 340. The control circuitry 142 can determine a temperature associated with the anatomical site 114 based on the temperature data. The temperature of the fluid removed by the suction device 330 can be lower than the temperature of the anatomical site 114. The temperature from the temperature sensor 338 can be adjusted (e.g., by a constant, proportional to the temperature, or based on the temperature) to account for cooling as the fluid is removed from the anatomical site 114. The difference between the measured temperature data and the temperature of the anatomical site 114 can be empirically determined and / or theoretically calculated prior to the therapeutic procedure.

[0052] The flow sensor 336 may be located on or at least partially within the suction device 330 or the conduit 332. The flow sensor 336 may provide flow data to the control circuitry 142 via a communication medium 342. The flow data may indicate how quickly fluid and debris are being removed from the anatomical site 114. A user or the control circuitry 142 may adjust settings of the suction device 330, such as the flow rate of the suction device 330. The control circuitry 142 may change the flow rate of the suction device 330 by issuing a control signal over the communication medium 344. The control circuitry 142 may determine a temperature associated with the anatomical site based on temperature data from the temperature sensor 338, temperature data from the temperature sensor 138, flow data from the flow sensor 336, or a combination thereof. The control circuitry 142 may increase the flow rate of fluid in the conduit 134 and / or the suction device 330, such as by changing the temperature of the anatomical site 114. The control circuit 142 may vary the temperature setpoint of the fluid cooler 228 based on temperature data from the temperature sensor 338, flow rate data from the flow sensor 336, temperature data from the temperature sensor 138, or a combination thereof.

[0053] The user interface 226 may provide a view of flow rate data, temperature data, or other data provided to the control circuit 142. The user interface 226 may provide the user with a view of the current settings of the suction device 330, such as the flow rate and another parameter related to flow rate, such as the pump speed of a pump associated with the suction device 330.

[0054] FIG. 4 illustrates, by way of example, a block diagram of a system 400 for managing the fluid temperature of a mixed fluid delivered to an anatomical site 114 or the pressure at the anatomical site 114. System 400 includes some components of systems 100A, 100B, and 200, and includes some additional components. System 400 may include a suction device 330, a temperature sensor 338, a flow sensor 336, a conduit 332, one or more communication media 344, 342, 340, 222, a display device 224, or a combination thereof. The additional components in FIG. 4 include a fluid reservoir 440, a conduit 442, an actuated valve 444, a temperature sensor 446, a conduit 448, a pump 450, a flow sensor 452, and communication media 456, 458, 460, 462.

[0055] Fluid reservoir 440 may be the same source as fluid reservoir 102 or a different source. The fluid in fluid reservoir 440 may be saline or another fluid. The fluid from fluid reservoir 440 may travel through conduit 442 to actuated valve 444. The temperature of the fluid from fluid reservoir 440 is sometimes referred to as a "direct fluid" because it does not pass through a heater or cooler before being delivered to anatomical site 114.

[0056] The actuation valve 444 can receive both fluid from the fluid reservoir 440 and cooled fluid from the fluid cooler 228. The cooled fluid can be provided to a conduit 466 coupled between the fluid cooler 228 and the actuation valve 444. The actuation valve 444 can mix the fluid from the fluid reservoir 440 with the cooled fluid. The effective size of the output orifice can be adjusted by a control signal from the control circuit 142 over the communication medium 456. For example, the control signal can cause a motor coupled to the output orifice to increase or decrease the opening provided by the orifice. Thus, the control circuit 142 can titrate how much fluid is provided to the output of the actuation valve 444 and ultimately to the anatomical site 114. The actuation valve includes a valve actuator that uses a power source coupled to a mechanically coupled motor of the actuation valve 444 to operate the valve. The power source can be electric, pneumatic, or hydraulic. The actuation valve 444 can be rotary or linear.

[0057] The control circuit 142 can increase the amount of fluid provided to the anatomical location 114 by opening one or more orifices in the actuated valve 444. The control circuit 142 can decrease the amount of fluid provided to the anatomical location 114 by closing one or more orifices in the actuated valve 444. The control circuit 142 can adjust the opening of the orifices in the actuated valve 444 by issuing a control signal over the communication medium 456.

[0058] By adjusting the opening size of one or more orifices in the actuated valve 444, the control circuit 142 can adjust the temperature of the fluid in the conduit 134 and thus change the temperature of the fluid provided to the anatomical location 114. For example, there may be two separate orifices (or valves) associated with the direct fluid and the cooled fluid, respectively. By adjusting the state (e.g., opening size or degree of opening) of each orifice (or valve), the temperature of the mixed fluid in the conduit 134 can be controlled. The temperature of the mixed fluid can be determined based on the temperature associated with the anatomical location 114, the length of the conduit 134 between the valve 444 and the anatomical location 114, or a combination thereof. The temperature of the anatomical location 114 can be compensated for heating or cooling occurring along the length of the conduit 134, such as by energy delivered by the energy delivery device 118, airflow provided by the suction device 330, or a combination thereof. The temperature of the mixed fluid can be adjusted to ensure that the temperature of the anatomical location 114 is maintained within a user-specified (or default) acceptable temperature range.

[0059] The temperature sensor 446 may be on or at least partially within the actuated valve 444. The temperature sensor 446 may provide temperature data indicative of the temperature of the mixed fluid within the actuated valve 444. The temperature data may be provided to the control circuit 142 using a communication medium 458.

[0060] A conduit 448 can provide the mixed fluid from the actuated valve 444 to a pump 450. The pump 450 can include a peristaltic pump or similar fluid pump. The pump 450 can include an adjustable pump speed that affects the flow rate of the mixed fluid in the conduit 134. The pump speed of the pump 450 can be adjusted by the control circuit 142. The control circuit 142 can issue a control signal over the communication medium 460 to adjust the pump speed of the pump 450.

[0061] The flow sensor 452 can provide flow data to the control circuit 142 over the communication medium 462. The flow data can indicate how much fluid passes through the conduit 134 per unit time. The control circuit 142 can increase the pump speed (and the flow rate of the mixed fluid) to decrease the temperature of the anatomical site 114.

[0062] The pressure sensor 150 can provide pressure data to the control circuitry 142 via the communication medium 154. The pressure data can indicate fluid pressure near the anatomical site and / or pressure against tissue at the anatomical site 114. The pressure sensor 150 can be integrally formed with the scope 120, removably coupled to the scope 120, attached to the scope 120, or physically separate from the scope 120. The pressure at the anatomical site 114 can indicate how much gas is being retained due to fluid evaporation, how much fluid and debris has accumulated within the anatomical site 114, the temperature associated with the anatomical site 114, or a combination thereof. The pressure at the anatomical site 114 can affect the efficiency of energy delivered to the anatomical site 114. By controlling the pressure, the control circuitry 142 can help ensure that energy delivery is effective and safe.

[0063] User interface 226 (see FIGS. 2 and 3) may provide a view of temperature data from temperature sensor 446, the state of actuation valve 444 (how open or closed the valve is), the pumping speed of pump 450, the flow rate of the mixed fluid in conduit 134, pressure data from pressure sensor 150, or a combination thereof. The data provided on user interface 226 may provide a user with better information about the status and effectiveness of energy delivery.

[0064] FIG. 5 shows, by way of example, a block diagram of a system 500 for managing the fluid temperature of a mixed fluid provided to an anatomical site 114. System 500 includes the components of systems 100A, 100B, 200, 300, and 400. System 500 includes additional components, including another fluid reservoir 550, a conduit 552, a fluid heater 554, a conduit 556, a communication medium 558, a communication medium 562, and an alarm device 560. System 500 includes fluids of three different temperatures that are mixed at actuated valve 444. The fluids include cooled fluid from fluid cooler 228, fluid directly from fluid reservoir 440, and heated fluid from fluid heater 554. While three different temperatures of fluid are shown, fluids of only two different temperatures or fluids of four or more temperatures may be used.

[0065] Fluid reservoir 550 can be the same or a different fluid source as fluid reservoir 440 or fluid reservoir 102. Fluid heater 554 can receive fluid from fluid reservoir 550 by conduit 552. Fluid heater 554 can include electric, electromagnetic, ceramic, or other heaters. Fluid heater 554 can increase the temperature of the fluid from fluid reservoir 550. The heated fluid can be supplied to actuation valve 444 by conduit 556.

[0066] The control circuit 142 can adjust the temperature set point of the fluid heater 554. The control circuit 142 can provide a control signal over the communication medium 558 that causes a change in the temperature set point of the fluid heater 554. The control circuit 142 can increase the temperature set point of the fluid heater 554 to increase the temperature of the fluid provided to the anatomical location 114 via the conduit 134. The control circuit 142 can decrease the temperature set point of the fluid heater 554 to decrease the temperature of the fluid provided to the anatomical location 114 through the conduit 134.

[0067] By adjusting the opening size of one or more orifices in the actuated valve 444, the control circuit 142 can adjust the temperature of the fluid in the conduit 134 and thus change the temperature of the fluid provided to the anatomical location 114. For example, there may be three separate orifices (or valves) associated with heated, direct, and cooled fluids, respectively. By adjusting the state (e.g., opening size or degree of opening) of each orifice (or valve), the temperature of the mixed fluid in the conduit 134 can be controlled. The temperature of the mixed fluid can be determined based on the temperature associated with the anatomical location 114, the length of the conduit 134 between the valve 444 and the anatomical location 114, or a combination thereof. The temperature of the anatomical location 114 can be compensated for heating or cooling occurring along the length of the conduit 134 due to energy delivered by the energy delivery device 118, airflow provided by the suction device 330, a combination thereof, etc. The temperature of the mixed fluid can be adjusted to ensure that the temperature of the anatomical location 114 is maintained within a user-specified (or default) acceptable temperature range.

[0068] The user interface 226 may provide data indicative of the temperature setpoint or another temperature setpoint of the fluid heater 554. A user may adjust the temperature setpoint or another temperature setpoint of the fluid heater 554 via the user interface 226.

[0069] By knowing the irrigation inflow and outflow rates, the temperature of the irrigation inflow and outflow, and the energy setting of the energy control system 116 (e.g., joules per pulse, watts, etc.), the control circuit 142 can monitor the amount of energy entering and leaving the anatomical site 114. Equation (1) illustrates this relationship.

[0070] T=T inflow +0.239ΔE / ΔV (1)

[0071] ΔE is the cumulative difference in energy (e.g., in joules) at a given instant, ΔV is the difference in the volume of irrigation fluid (e.g., in cubic centimeters) entering and leaving the surgical space at the same instant, and T inflow where θ is the temperature of the fluid entering the anatomical site 114, and T is the average temperature of the irrigation fluid at that instant within the anatomical site 114. Details regarding methods for determining the temperature of an anatomical site are described in U.S. Patent Publication No. 2018 / 0055568, entitled "Automatic Irrigation-Coordinated Lithotripsy," filed August 25, 2018, which is incorporated herein by reference in its entirety.

[0072] The control circuit 142 can estimate the temperature of the anatomical site 114 by monitoring the inflow and outflow irrigation rates, the energy applied to the anatomical site 114 by the energy delivery device 118, and the temperature of the inflow fluid (such as saline) over the same duration using equation (1).

[0073] The communication medium 562 can provide the alert data to the alert device 560. The alert device 560 can include a display, speaker, motor, etc. configured to indicate that a temperature threshold has been violated. The display 224 can additionally or alternatively provide the alert data. The speaker can provide an audio indication that a threshold has been violated, which threshold has been violated, or a combination thereof. The motor can provide a vibration (haptic feedback) that indicates that a threshold has been violated, which threshold has been violated, or a combination thereof. The display can provide a visual alert that indicates that a threshold has been violated, which threshold has been violated, or a combination thereof.

[0074] 6 shows, by way of example, a diagram of an embodiment of a method 600 for temperature management of an anatomical site. Method 600 may include operations performed by one or more of the components of one or more of systems 100A, 100B, 200, 300, 400, 500, or combinations thereof. The illustrated method 600 includes providing optical or electrical energy to the anatomical site at operation 660, providing a fluid to the anatomical site via a first conduit at operation 662, receiving a first temperature associated with the anatomical site at operation 664 in a control circuit, and titrating, by the control circuit, at least one of a second temperature or a flow rate parameter of the fluid to the anatomical site based on the first temperature at operation 666 to provide a control signal that manages the temperature of the anatomical site toward a desired target temperature.

[0075] The method 600 can further include removing fluid from the anatomical site with a suction device and providing the removed fluid. The method 600 can further include transporting the removed fluid to a waste fluid dispenser with a second conduit in fluid communication with the suction device. The first temperature can be the temperature of the removed fluid or the temperature of the fluid at the anatomical site.

[0076] The method 600 may further include cooling a first portion of the fluid with a fluid cooler to provide a cooled fluid. The method 600 may further include providing the cooled fluid through a second conduit. The method 600 may further include adjusting, by the control circuit, a second temperature to which the fluid cooler cools the cooled fluid based on the first temperature.

[0077] The method 600 may further include heating a second portion of the fluid with a fluid heater to provide a heated fluid. The method 600 may further include providing the heated fluid through a third conduit. The method 600 may further include adjusting, by the control circuit, a third temperature to which the fluid heater heats the cooled fluid based on the first temperature.

[0078] The method 600 may further include providing, by a display electrically coupled to the control circuit, a view of the first temperature, the temperature set point of the fluid heater, the temperature set point of the fluid cooler, the flow rate of fluid to the anatomical site, the flow rate of fluid leaving the anatomical site, the temperature of the mixed water, the pressure of the anatomical site, the temperature of the fluid exiting the anatomical site, the pump speed of the pump, or a combination thereof.

[0079] 7 illustrates, by way of example, a flow diagram of a method 700 for determining temperature, pressure, or a combination thereof at an anatomical location 114. The method 700 may be performed, for example, by the control circuitry 142. The illustrated method 700 includes receiving energy data 770, temperature data 772, pressure data 774, flow data 776, or a combination thereof. The illustrated method 700 further includes determining a temperature or pressure associated with the anatomical location 114 in operation 778.

[0080] The energy data 770 relates to one or more settings of the energy control system 116. The settings define the operating parameters of the energy control system 116. The operating parameters may include amplitude, frequency, voltage, current, phase, power, or a combination thereof, etc. The energy data 770 may be provided by the energy control system 116 via the communication medium 146 or may be known by the control circuitry 142 (because the control circuitry 142 can set the operating parameters).

[0081] The temperature data 772 may include data from any of the temperature sensors in any of the systems 100A, 100B, 200, 300, 400, or 500. The temperature data 772 may be related to the fluid entering the anatomical site 114, the fluid exiting the anatomical site 114, or the ambient temperature of the room in which the system 100A, 100B, 200, 300, 400, 500 is located. The temperature data may include a temperature set point for the fluid cooler 228, the fluid heater 554, or a combination thereof.

[0082] The pressure data 774 may represent a measured pressure at the anatomical location 114. The pressure data 774 may represent a fluid pressure, a gas pressure, or a total pressure at the anatomical location 114. The pressure data 774 may be from the pressure sensor 150 or another pressure sensor.

[0083] The flow data 776 may indicate the rate at which fluid is flowing within a particular confined area. The flow data 776 may be from any of the flow sensors 148, 336, 452, another flow sensor, the pump 450, the suction device 330, or a combination thereof. The flow data 776 may indicate a flow rate or a pump speed. The flow data 776 may indicate a volume per unit time moved by the pump 450.

[0084] Operation 778 may include estimating the temperature, pressure, or both at the anatomical location 114. The pressure may be determined based on pressure data 774, temperature data 772, flow data 776, energy data 770, or a combination thereof. Generally, an increase in temperature means an increase in pressure. The greater the delta between the flow rate into the anatomical location 114 and the flow rate out of the anatomical location 114, the higher the pressure. The greater the amount of energy provided to the anatomical location 114, the higher the temperature and therefore the pressure at the anatomical location. The control circuitry 142 may weight all or only some of these factors when determining the pressure in operation 778.

[0085] The temperature may be determined based on pressure data 774, temperature data 772, flow rate data 776, energy data 770, or a combination thereof. An increase in pressure generally means an increase in temperature. The higher the flow rate of fluid to the anatomical location 114, the closer the temperature of the anatomical location 114 will be to the temperature of the fluid to the anatomical location 114. The greater the amount of energy provided to the anatomical location 114, the higher the temperature of the anatomical location 114. The control circuitry 142 may weight all or only some of these factors when determining the temperature in operation 778.

[0086] FIG. 8 illustrates, by way of example, a diagram of a method 800 for adjusting one or more components of system 100A, 100B, 200, 300, 400, or 500 to regulate the temperature of anatomical site 114. Method 800 may be performed, at least in part, by control circuitry 142. The illustrated method 800 includes receiving data in operation 880. The received data may include any of pressure data 774, temperature data 772, flow rate data 776, energy data 770, or a combination thereof (see FIG. 7). Operation 880 may include determining a temperature associated with the anatomical site (e.g., by performing operation 778 of FIG. 7). In operation 882, the temperature may be compared to a first criterion. If the temperature meets the first criterion (indicating that the temperature is too high or trending toward being too high), operation 884 may be performed. If the temperature does not meet the first criterion, operation 886 may be performed.

[0087] The first criterion may include a temperature greater than a specified threshold temperature, a rate of change of temperature greater than another specified threshold, e.g., positive, a combination thereof, etc. Operation 884 may include (e.g., in response to determining that the temperature meets the first criterion) (i) decreasing the temperature of the fluid to the anatomical location 114, such as by lowering the temperature setpoint of the fluid heater 554, lowering the temperature setpoint of the fluid cooler 228, reducing the opening of an orifice of an actuated valve providing heated fluid, or increasing the opening of an orifice of an actuated valve providing cooled, direct fluid, or a combination thereof, (ii) increasing the amount of fluid provided to the anatomical location 114, such as by increasing the pumping speed of the pump 450, increasing the opening of an orifice of an actuated valve providing cooled, direct fluid, or a combination thereof, (iii) increasing the amount of fluid and debris removed from the anatomical location 114 (e.g., increasing the pumping speed of the suction device 330), or (iv) decreasing the amount of energy provided by the energy delivery device 118, a combination thereof, etc.

[0088] The temperature may be compared to a second criterion in operation 886. If the temperature meets the second criterion (indicating that the temperature is too low or trending toward being too low), operation 888 may be performed. If the temperature does not meet the second criterion, operation 880 may be performed.

[0089] The second criterion may include a temperature below a certain threshold temperature, a rate of change of a negative temperature having a magnitude greater than another certain threshold, or a combination thereof, etc. Operation 888 may include (e.g., in response to determining that the temperature meets the second criterion) (i) increasing the temperature of the fluid to the anatomical location 114, e.g., by increasing the temperature set point of the fluid heater 554, raising the temperature set point of the fluid cooler 228, increasing the opening of an orifice of an actuated valve providing heated fluid, or reducing the opening of an orifice of an actuated valve providing cooled fluid, direct fluid, or a combination thereof, (ii) reducing the amount of fluid provided to the anatomical location 114, e.g., by decreasing the pumping speed of the pump 450, reducing the opening of an orifice of an actuated valve providing cooled fluid, direct fluid, or a combination thereof, (iii) increasing the amount of fluid and debris removed from the anatomical location 114 (e.g., increasing the pumping speed of the suction device 330), or (iv) increasing the amount of energy provided by the energy delivery device 118, combinations thereof, etc.

[0090] It should be noted that removing fluid and debris from the anatomical site 114 may increase the temperature of the anatomical site 114, for example, if the temperature of the fluid at the anatomical site 114 is lower than the ambient temperature and can act to lower the temperature at the anatomical site 114, or if the temperature of the fluid at the anatomical site 114 is higher than the ambient temperature.

[0091] There are many relationships that can be derived from measurements of flow rate, temperature, time, pressure, or a combination thereof. One such relationship can involve determining the rate of temperature change (temperature change per unit time), which can be projected in time to estimate how long it will take to reach a user-defined temperature threshold. For example, a countdown could be displayed on the user interface 226 displaying the time remaining until the temperature of the anatomical site 114 is predicted to reach one of the thresholds. The user interface 226 can provide the user with views of measurements, predictions, etc., such as providing the user with information about the rate of change and time until the threshold is exceeded, so that the user can make appropriate decisions about what is best for the patient.

[0092] FIG. 9 illustrates, by way of example, a diagram of a method 900 for adjusting one or more components of system 100A, 100B, 200, 300, 400, or 500 to regulate pressure at anatomical site 114. Method 900 may be performed, at least in part, by control circuitry 142. The illustrated method 900 includes receiving data in operation 990. The received data may include any of pressure data 774, temperature data 772, flow rate data 776, energy data 770, or a combination thereof (see FIG. 7). Operation 990 may include determining a pressure associated with the anatomical site (e.g., by performing operation 778 of FIG. 7). The illustrated method 900 includes determining whether the pressure meets a third criterion in operation 992. If the pressure meets the third criterion (indicating that the pressure is too high or trending toward being too high), operation 994 may be performed. If the pressure does not meet the third criterion, operation 990 may be performed.

[0093] The third criteria may include pressure greater than a specified pressure threshold, a rate of change of pressure that is, for example, positive and greater than another specified pressure threshold, a combination thereof, and the like. Operation 994 may include (e.g., in response to determining that the pressure meets the third criterion) (i) decreasing the temperature of the fluid to the anatomical location 114 by, for example, decreasing the temperature set point of the fluid heater 554, decreasing the temperature set point of the fluid cooler 228, reducing the opening of an orifice of an actuated valve 444 supplying heated fluid, or increasing the opening of an orifice of an actuated valve 444 providing cooled fluid, heated fluid, direct fluid, or a combination thereof; (ii) decreasing the amount of fluid provided to the anatomical location 114, for example, by decreasing the pumping speed of the pump 450, reducing the opening of an orifice of an actuated valve 444 providing cooled fluid, heated fluid, direct fluid, or a combination thereof; (iii) increasing the amount of fluid and debris removed from the anatomical location 114 (e.g., increasing the pumping speed of the suction device 330); or (iv) decreasing the amount of energy provided by the energy delivery device 118, combinations thereof, etc.

[0094] One or more of systems 100A, 100B, 200, 300, 400, 500 can maintain the temperature of anatomical site 114 near a specified temperature (e.g., 37°C / normal body temperature), such as during performance of one or more of methods 600, 700, 800, or 900, thereby allowing a physician to use a higher-power treatment system, resulting in more efficient and faster treatment times. Due to excess heat generated by high-power energy treatment systems, teachings provide refrigerated (or otherwise cooled) irrigation fluid. The teachings can use a feedback-driven system to control the fluid temperature in situ.

[0095] The use of chilled irrigation fluid allows for the temperature of the anatomical / treatment site to be controlled by adding the appropriate amount of chilled fluid as needed or by adding heat if the temperature becomes too low. Such systems can include a valve, allowing room temperature saline, chilled saline, and / or heated saline to be one or more inputs to the valve to allow for precise control of the temperature of the irrigation fluid. Feedback temperature from the anatomical site, excess fluid, etc. can provide temperature and flow rate information to logic that can determine how to control the valve and irrigation pump.

[0096] 10 shows, by way of example, a block diagram of one embodiment of a machine 1000 (e.g., a computer system) for implementing one or more embodiments. Machine 1000 can perform methods for temperature management of an anatomical site, such as methods 600, 700, 800, 900, portions thereof, or combinations thereof in whole or in part. Control circuitry 142, energy control system 116, energy delivery device 118, scope 120, temperature sensor 138, fluid cooler 228, display 224, flow sensor 336, temperature sensor 338, actuated valve 444, pump 450, flow sensor 452, temperature sensor 446, pressure sensor 150, fluid heater 554, or a combination thereof, may comprise one or more components of machine 1000.

[0097] The example machine 1000 (in the form of a computer) may include a processing unit 1002, memory 1003, removable storage 1010, and non-removable storage 1012. While an exemplary computing device is shown and described as machine 1000, the computing device may take different forms in different embodiments. For example, the computing device may instead be a smartphone, tablet, smartwatch, or other computing device that includes the same or similar elements as shown and described with respect to FIG. 10 . Devices such as smartphones, tablets, and smartwatches are collectively referred to as mobile devices. Additionally, while various data storage elements are shown as part of machine 1000, the storage may also or alternatively include cloud-based storage accessible via a network such as the Internet.

[0098] The memory 1003 may include volatile memory 1014 and nonvolatile memory 1008. The machine 1000 includes, or has access to a computing environment that includes, a variety of computer-readable media, such as volatile memory 1014 and nonvolatile memory 1008, removable storage 1010 and non-removable storage 1012. The computer storage may include random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, or other memory technology, compact disc read-only memory (CD ROM), digital versatile disc (DVD) or other optical disk storage, magnetic cassette, magnetic tape, magnetic disk storage, or other magnetic storage device capable of storing computer-readable instructions for performing the functions described herein.

[0099] The machine 1000 includes or has access to a computing environment including an input 1006, an output 1004, and a communication connection 1016. The output 1004 may include a display device such as a touchscreen that also functions as an input device. The input 1006 may include one or more of a touchscreen, a touchpad, a mouse, a keyboard, a camera, one or more device-specific buttons, one or more sensors integrated within the machine 1000 or coupled to the machine 1000 via a wired or wireless data connection, and other input devices. The computer operates in a networked environment using the communication connection and can connect to one or more remote computers, such as cloud-based servers and database servers including storage devices. Remote computers may include personal computers (PCs), servers, routers, network PCs, peer devices, or other common network nodes. The communication connection may include a local area network (LAN), a wide area network (WAN), cellular, Institute of Electrical and Electronics Engineers (IEEE) 802.11 (Wi-Fi), Bluetooth, or other networks.

[0100] Computer-readable instructions stored on the computer-readable storage device are executable by the processing unit 1002 (sometimes referred to as a processing circuit) of the machine 1000. Hard drives, CD-ROMs, RAM are some examples of articles that include non-transitory computer-readable media, such as storage devices. For example, a computer program 1018 may be used to cause the processing unit 1002 to perform one or more of the methods or algorithms described herein.

[0101] Additional Notes and Examples Example 1 includes a therapy delivery system comprising: a scope configured to provide a view of an anatomical site; an energy delivery device configured to deliver therapeutic energy to the anatomical site; a first irrigation conduit configured to transport a fluid to the anatomical site; a first temperature sensor positioned to provide first temperature data associated with the anatomical site; and control circuitry electrically coupled to receive the first temperature data, the control circuitry configured to adjust at least one of (i) a first temperature of the fluid, (ii) a flow rate parameter of the fluid, or (iii) a setting of the energy delivery device to manage a second temperature of the anatomical site based at least in part on the first temperature data.

[0102] Example 2 can include the components of Example 1, further including a suction device configured to remove fluid from the anatomical site and provide the removed fluid; and a second irrigation conduit in fluid communication with the suction device and configured to receive the removed fluid and transport the removed fluid from the anatomical site, wherein the first temperature data is a third temperature of the removed fluid.

[0103] In Example 3, at least one of Examples 1-2 can further include: the first temperature data includes a second temperature.

[0104] In Example 4, at least one of Examples 1-3 may further include a fluid cooler in fluid communication with the fluid, the fluid cooler configured to receive and cool a first portion of the fluid to provide a cooled fluid, and the control circuitry adjusts, based on the first temperature data, a fourth temperature to which the fluid cooler cools the cooled fluid.

[0105] In Example 5, the system of Example 4 can further include a third irrigation conduit in fluid communication with the fluid, the third irrigation conduit configured to receive a second portion of the fluid, and the first irrigation conduit configured to receive a mixture of both the second portion of the fluid and the cooled fluid.

[0106] In Example 6, at least one of Examples 4-5 can further include a fluid heater in fluid communication with the fluid, the fluid heater positioned to receive and heat a third portion of the fluid to provide a heated fluid, and the first irrigation conduit configured to receive a mixture of both the heated and cooled fluids.

[0107] In Example 7, Example 6 may further include at least one actuated valve in fluid communication with the first irrigation conduit and electrically coupled to the control circuit, wherein the at least one actuated valve is disposed between the fluid cooler and the first irrigation conduit and / or between the fluid heater and the first irrigation conduit, and the control circuit is configured to change a physical state of the actuated valve based on the first temperature data.

[0108] In Example 8, Example 7 can further include a second temperature sensor positioned to determine a fifth temperature of the fluid from the actuated valve, and the control circuitry further configured to adjust respective temperature settings of the fluid heater and the fluid cooler based on the fifth temperature.

[0109] In Example 9, at least one of Examples 1-8 can further include a pump in fluid communication with the first irrigation conduit and electrically coupled to the control circuit, the control circuit configured to adjust a pumping speed of the pump based on the first temperature data.

[0110] In Example 10, Example 9 can further include a pressure sensor electrically coupled to the control circuit and positioned to generate pressure data representative of pressure around the anatomical site, the control circuit further configured to adjust a pumping speed of the pump based on the pressure data.

[0111] In Example 11, at least one of Examples 9-10 can further include a flow sensor positioned to determine a flow rate of fluid from the pump, the flow sensor electrically coupled to the control circuit, and the control circuit further configured to adjust the speed of the pump based on the flow rate.

[0112] In Example 12, at least one of Examples 1-11 can further include the control circuitry being configured to adjust settings of the energy delivery device to manage the temperature of the anatomical site based on the first temperature data.

[0113] In Example 13, at least one of Examples 1-12 can further include a display device electrically coupled to the control circuit, the display device configured to provide a view of the first temperature to a user.

[0114] In Example 14, Example 13 can further include an alarm device configured to generate audio, visual, or tactile feedback indicating that the first temperature has exceeded or is about to exceed the threshold temperature.

[0115] In Example 15, at least one of Examples 13-14 provides a user interface, wherein the display is configured to receive data indicating a first temperature setpoint above which to maintain the anatomical site and a second temperature setpoint below which to maintain the anatomical site, and the control circuitry automatically operates to manage the temperature of the anatomical site between the first temperature setpoint and the second temperature setpoint.

[0116] Example 16 includes a method including providing light or electrical energy to an anatomical site; providing fluid to the anatomical site via a first irrigation conduit; receiving, in a control circuit, a first temperature associated with the anatomical site; and providing, by the control circuit, a control signal that titrates at least one of a second temperature or flow rate parameter of the fluid to the anatomical site based on the first temperature, to manage the temperature of the anatomical site toward a desired target temperature.

[0117] In Example 17, Example 16 can further include removing fluid from the anatomical site with a suction device to provide removed fluid, and transporting the removed fluid to a waste container with a second irrigation conduit in fluid communication with the suction device, wherein the first temperature is the temperature of the removed fluid.

[0118] In Example 18, example 17 can further include the first temperature being a temperature of a fluid at the anatomical site.

[0119] In Example 19, at least one of Examples 17-18 can further include cooling a first portion of the fluid with a fluid cooler to provide a cooled fluid; and providing the cooled fluid through a second irrigation conduit, wherein the control circuit adjusts a second temperature to which the fluid cooler cools the cooled fluid based on the first temperature.

[0120] In Example 20, at least one of Examples 17-19 can further include providing a view of the first temperature by a display electrically coupled to the control circuit.

[0121] Example 21 includes a therapy delivery system comprising: a scope configured to provide a view of the anatomical site; an energy delivery device configured to provide electrical or light energy to the anatomical site; at least one actuated valve; a first irrigation conduit in fluid communication with a first portion of the fluid and the at least one actuated valve, the first irrigation conduit configured to provide the first portion directly to the actuated valve to result in a direct fluid; a fluid cooler in fluid communication with a second portion of the fluid and the at least one actuated valve, the fluid cooler configured to cool the second portion of the fluid based on a temperature setting of the fluid cooler to result in a cooled fluid; a second irrigation conduit in fluid communication with a mixture of the cooled fluid and the direct fluid; a first temperature sensor positioned to provide first temperature data associated with the anatomical site; and control circuitry electrically coupled to the first temperature sensor, the control circuitry configured to receive the first temperature data and adjust a state of the at least one actuated valve, a temperature setting, or a combination thereof to provide a control signal to manage the temperature of the anatomical site.

[0122] The foregoing description and drawings sufficiently illustrate particular embodiments to enable those skilled in the art to practice them. Other embodiments may incorporate structural, logical, electrical, process, and other changes. Portions and features of some embodiments may be included in, or substituted for, portions and features of other embodiments. Embodiments set forth in the claims encompass all available equivalents of those claims.

[0123] Throughout this specification, components, operations, or structures described as a single example may be implemented in multiple examples. While individual operations of one or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed simultaneously, and the operations need not be performed in the order illustrated. Structures and functions shown as separate components in configuration examples may be implemented as combined structures or components. Similarly, structures and functions shown as a single component may be implemented as separate components. These and other changes, modifications, additions, and improvements are within the scope of the subject matter of this specification.

[0124] Although the inventive subject matter has been generally described with reference to certain exemplary embodiments, various modifications and changes can be made to these embodiments without departing from the broader scope of the disclosed embodiments. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention" for convenience only, without any intention to intentionally limit the scope of this application to any single disclosure or inventive concept when in fact more than one is disclosed.

[0125] The embodiments set forth herein are described in sufficient detail to enable those skilled in the art to practice the disclosed teachings. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Therefore, the detailed description is not to be construed in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0126] The term "or" as used herein may be interpreted in either an inclusive or exclusive sense. Furthermore, multiple examples of resources, operations, or structures described herein may be provided as a single example. Moreover, boundaries between various resources, operations, modules, engines, and data stores are somewhat arbitrary, and particular operations are illustrated in the context of specific illustrative configurations. Other allocations of functionality are contemplated and may be within the scope of various embodiments of the present disclosure. In general, structures and functions shown as separate resources in example configurations may be implemented as a combined structure or resource. Similarly, structures and functions displayed as a single resource may be implemented as separate resources. These and other variations, modifications, additions, and improvements are included within the scope of the embodiments of the present disclosure, as expressed by the appended claims. The specification and drawings are, therefore, to be regarded in an illustrative and not a restrictive sense.

[0127] The foregoing description has been set forth with reference to specific exemplary embodiments for purposes of explanation. However, the exemplary discussion above is not intended to be exhaustive or to limit the possible exemplary embodiments to the precise form disclosed. Many modifications and variations are possible in light of the above teachings. The exemplary embodiments were chosen and described in order to best explain the principles involved and their practical application, so as to enable others skilled in the art to make full use of various exemplary embodiments with various modifications as suited to the particular uses contemplated.

[0128] The terminology used in the description of exemplary embodiments herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. When used in the description of exemplary embodiments and the accompanying examples, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. It will also be understood that the term "and / or," as used herein, refers to and encompasses any and all possible combinations of one or more of the associated listed items. It will further be understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0129] As used herein, the term "when" can be interpreted to mean "when," "in response to determining," or "in response to detecting," depending on the context. Similarly, the phrase "when determined" or "when [a described condition or event] is detected" can be interpreted to mean "when determined," or "in response to determining," or "when [a described condition or event] is detected," or "in response to detecting [a described condition or event]," depending on the context. [Explanation of symbols]

[0130] 100A, 100B, 200, 300, 400, 500 systems 102, 440, 550 Fluid Reservoir 114 Anatomical Sites 116 Energy Control System 118 Energy delivery devices, therapeutic devices 120 Energy Delivery Scope (Endoscope) 134, 230, 442, 448, 466, 552, 556 conduit 136, 146, 154, 220, 222, 340, 342, 456, 458, 460, 462, 558, 562 Communication medium 138, 338, 446 Temperature Sensors 140 Telecommunications Media 142 control circuit 148, 336, 452 Flow Sensors 150 Pressure Sensor 224 Displays and display devices 228 Fluid Cooler 330 Suction device 332 Second Conduit 334 Waste containers 336 Flow Sensor 444 Actuated valve 450 Pump 554 Fluid heater 560 Alarm device 600, 700, 800, 900 methods 770 Energy Data 772 Temperature Data 774 Pressure Data 776 Flow Data 1000 machines 1002 Processing equipment 1003 memory 1004 Output 1006 Input 1008 Non-volatile memory 1010 Removable Storage Device 1012 Non-removable Storage Devices 1014 Volatile Memory 1016 Communication Connection

Claims

1. 1. A therapeutic delivery system comprising: a scope configured to provide a view of the anatomical site; an energy delivery device configured to deliver therapeutic energy to the anatomical site; a first irrigation conduit configured to deliver fluid to the anatomical site; a second irrigation conduit physically separated from the first irrigation conduit and configured to allow fluid to exit the anatomical site; a first temperature sensor positioned to provide first temperature data of a temperature associated with the anatomical site; at least one pump in fluid communication with the first irrigation conduit; at least one of a fluid cooler in fluid communication with the fluid and configured to deliver cooled fluid to the anatomical location, or a fluid heater in fluid communication with the fluid and configured to deliver heated fluid to the anatomical location; a control circuit electrically coupled to receive the first temperature data, the control circuit configured to manage a temperature of the anatomical location by independently controlling the flow rate of the fluid into the anatomical location and the flow rate of the fluid out of the anatomical location based at least in part on the first temperature data by adjusting at least one of a temperature set point of the fluid cooler, a temperature set point of the fluid heater, a flow rate of the fluid into the anatomical location, or a flow rate of the fluid out of the anatomical location; and Equipped with Therapeutic delivery systems.

2. further comprising a suction device configured to remove fluid from the anatomical site and provide the removed fluid; the second irrigation conduit is in fluid communication with the suction device and configured to receive the removed fluid and transport the removed fluid from the anatomical site; the first temperature data indicating a second temperature of the removed fluid. The system of claim 1.

3. the fluid cooler is in fluid communication with the fluid and is configured to receive and cool a first portion of the fluid to provide a cooled fluid; the control circuit adjusts a third temperature to which the fluid cooler cools the cooled fluid based on the first temperature data. The system of claim 1.

4. a third irrigation conduit in fluid communication with the fluid, the third irrigation conduit configured to receive a second portion of the fluid; the first irrigation conduit is configured to receive a mixture of both the second portion of the fluid and the cooled fluid. The system of claim 3.

5. the fluid heater in fluid communication with the fluid is positioned to receive and heat a third portion of the fluid to provide a heated fluid; the first irrigation conduit is configured to receive a mixture of both the heated fluid and the cooled fluid.

5. The system of claim 4.

6. at least one actuated valve in fluid communication with the first irrigation conduit and electrically coupled to the control circuit, the at least one actuated valve being disposed between the fluid cooler and the first irrigation conduit and / or between the fluid heater and the first irrigation conduit. The system of claim 4.

7. the control circuit is configured to change a physical state of the actuated valve based on the first temperature data. The system of claim 6.

8. a second temperature sensor positioned to determine a fourth temperature of the fluid from the actuated valve; the control circuit is further configured to adjust temperature settings of each of the fluid heater and the fluid cooler based on the fourth temperature. The system of claim 7.

9. the control circuit is configured to adjust a pumping speed of the pump based on the first temperature data. The system of claim 1.

10. a pressure sensor configured to provide pressure data associated with the anatomical site; the control circuitry is further configured to adjust a pumping speed of the pump based on the pressure data. The system of claim 9.

11. a flow sensor electrically coupled to the control circuit and positioned to determine a flow rate of fluid from the pump; the control circuitry is further configured to adjust the speed of the pump based on the flow rate. The system of claim 9.

12. the control circuitry is configured to adjust settings of the energy delivery device to manage the temperature of the anatomical site based on the first temperature data. The system of claim 1.

13. a display electrically coupled to the control circuitry, the display configured to provide a user with a view of the temperature of the anatomical site. The system of claim 1.

14. further comprising an alarm configured to generate audio, visual, or tactile feedback indicating that the temperature of the anatomical site has exceeded or is about to exceed a threshold temperature. The system of claim 13.

15. the display device provides a user interface configured to receive data indicating a first temperature setpoint above which to maintain the anatomical site and a second temperature setpoint below which to maintain the anatomical site, and the control circuitry automatically operates to manage the temperature of the anatomical site between the first temperature setpoint and the second temperature setpoint. The system of claim 13.

16. 1. A therapeutic delivery system comprising: a scope configured to provide a view of the anatomical site; an energy delivery device configured to provide electrical or light energy to the anatomical site; a first irrigation conduit in fluid communication with a first portion of a fluid, the first irrigation conduit configured to provide the first portion directly to the actuation valve and provide the fluid directly; a fluid cooler in fluid communication with a second portion of the fluid and the at least one actuation valve, the fluid cooler configured to cool the second portion of the fluid based on a temperature setting of the fluid cooler to provide a cooled fluid; a second irrigation conduit physically separated from the first irrigation conduit, the second irrigation conduit configured to receive a mixed fluid that is a mixture of the cooled fluid and the direct fluid, the second irrigation conduit configured to transport the mixed fluid to the anatomical site; a first temperature sensor positioned to provide first temperature data associated with the anatomical site; at least one pump in fluid communication with the first irrigation conduit; a control circuit electrically coupled to the first temperature sensor, the control circuit configured to receive the first temperature data and manage a temperature of the anatomical location by independently controlling a flow rate of the fluid into the anatomical location and a flow rate of the fluid out of the anatomical location based at least in part on the temperature data by providing a control signal that adjusts a flow rate of the fluid into the anatomical location, a flow rate of the fluid out of the anatomical location, or a combination thereof, to manage a temperature of the anatomical location; Equipped with Therapeutic delivery systems.

Images