Active temperature control system for anatomical sites
The active cooling irrigation system addresses the challenge of temperature control during medical procedures by using sensors and adjustable fluid temperature and flow rate to maintain a safe anatomical temperature, preventing tissue damage and allowing for longer treatment times.
Patent Information
- Application Number
- JP2023539345
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-12-28
- Filing Date
- 2021-12-28
- Publication Date
- 2025-05-22
- Estimated Expiration
- 2041-12-28
AI Technical Summary
Existing irrigation systems for anatomical sites during endoscopic, arthroscopic, and lithotripsy procedures lack effective temperature control, leading to potential tissue damage from overheating or hypothermia.
An active cooling irrigation system that uses temperature sensors, flow rate measurements, and therapy delivery output settings to maintain a target anatomical temperature by adjusting the temperature and flow rate of irrigation fluids, which can be mixed to achieve various temperatures.
The system effectively manages anatomical site temperature, preventing overheating and hypothermia, thereby ensuring safer and more prolonged treatment durations during medical procedures.
Smart Images

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Abstract
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 by reference in its entirety.
[0002] These teachings relate to controlling the temperature of a fluid for irrigation of an anatomical site. [Background technology]
[0003] Endoscopic, arthroscopic, lithotripsy, and other procedures using scopes typically include irrigation to remove fluid from the body to clear the scope's view. Examples of body 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 the fluid out of the endoscope's field of view. This involves delivering pressurized fluid to the scope at the anatomical site. Such treatments include lasers, electrical power, 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 a target anatomical temperature that is automatically managed. The system can maintain temperature by monitoring one or more temperature sensor measurements, and / or one or more flow rate measurements, and / or a therapy delivery output setting. The system can observe or measure the rise and fall of temperature during the administration of a therapy at a particular setting, at a particular 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 flow rate and temperature of fluid required to maintain the desired anatomical temperature. Various fluid temperatures can be achieved by mixing frozen and room temperature or even heated fluids.
[0006] The therapy delivery device may include or 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 light 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 circuitry 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 positioned 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 pump 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 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 a temperature of the anatomical site based on the first temperature data. A display may be electrically coupled to the control circuitry. The display may be configured to provide a view of the first temperature to a user. The user interface may be configured to receive data indicative of a first temperature set point above which to maintain the anatomical site and a second temperature set point below which to maintain the anatomical site. The control circuitry may operate to manage a temperature of the anatomical site between the first temperature set point and the second temperature set point.
[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 description 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. [Diagram 2] FIG. 2 is a block diagram illustrating another system for managing fluid temperature of fluid provided to an anatomical site, as an example. [Diagram 3] FIG. 2 is a block diagram illustrating another system for managing fluid temperature of fluid provided to an anatomical site, as an 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. [Diagram 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] FIG. 1 illustrates, by way of example, one 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, as an example. [Figure 8] As an example, a diagram showing 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] As an example, a diagram showing 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 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 PREFERRED EMBODIMENTS
[0016] Endoscopic, arthroscopic, lithotripsy, and other procedures using scopes may include irrigation to remove fluid from the body to clear the view of the scope. In such limited procedures, this irrigation fluid is room temperature or heated saline. In addition to keeping the view clear, the fluid may also be used to cool the anatomical site. This cooling helps to control the temperature of the anatomical site if the treatment being performed causes the anatomical site (and the surrounding anatomical structures and fluids) to heat up. Such treatments may include lasers, electrical power, etc. Delivering too much fluid to an anatomical site too quickly can cause hypothermia in extreme cases, 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. Additionally, delivering fluid too slowly can run the risk of the fluid being too hot for an extended period of time. Therefore, the flow rate and starting temperature of the fluid, the duration of the procedure, or a combination of both, must be carefully considered during the procedure, thereby avoiding, or at least reducing, the risk of hypothermia and overheating of healthy tissue.
[0017] To mitigate temperature issues, physicians can use irrigation systems that actively heat or cool fluids. Body temperature fluids provide less cooling than cooler, actively cooled fluids. Anatomical sites with elevated temperatures due to treatments such as laser lithotripsy can benefit from cooler than body temperature fluids.
[0018] Proteins may begin to denature at approximately 42°C. It may be considered undesirable for the temperature of anatomical structures not subject to therapeutic intervention to reach this temperature. When using fluids at body temperature, therapeutic intervention will only increase the local anatomical temperature by approximately 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 temperature by 17°C-24°C before reaching the same temperature limit of 42°C. Assuming the same average power output of the therapeutic energy source (e.g., laser control system, power supply, generator, etc. that powers one or more lasers or electrodes), treatment can proceed 3-5 times longer using "room temperature fluids" compared to body temperature fluids (assuming there is a linear relationship when room temperature irrigation is used instead of body temperature irrigation). For interventions where the treatment is an energy device such as a laser or electrosurgical system, actively cooled irrigations can adequately accommodate longer treatment times at lower anatomical temperatures.
[0020] In the case of laser lithotripsy, the heating power of the treatment results in a large increase in anatomical temperature. The power of the treatment quickly results in overheating, even with room temperature fluid. To extend the continuous treatment time using laser lithotripsy, a cooled fluid source may be used. Increasing the continuous treatment time reduces the wait time for the target site to cool, thereby reducing the overall procedure time. The increased treatment time may allow the physician to use laser lithotripsy to break up, for example, kidney stones into small enough pieces without worrying about damaging the patient's tissue. The increased treatment time may allow the physician to continue removing the bad tissue using monopolar or bipolar electrodes. As used herein, cooled fluid means that the fluid is actively cooled beyond ambient cooling, whereas room temperature fluid (sometimes referred to as "direct fluid") is not actively cooled, but is only cooled by the ambient temperature. Active cooling means that electricity, gas, or any suitable cooling technology is used to reduce the temperature of the fluid faster than placing the fluid in a room and waiting for it to cool down. Chilled fluid from the cooling fluid source can extend treatment duration beyond that currently possible using direct fluid while keeping the average temperature of anatomical fluids near the treatment area below 42°C and above hypothermic levels.
[0021] The teachings herein provide for selective delivery of refrigerated (sometimes referred to as "cooling"), heated, direct (fluid not actively heated or cooled), or combinations thereof, irrigation fluid to an anatomical site. For example, if the anatomical temperature is rising 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 may be provided to the anatomical site through the scope, or a conduit coupled to or used with the scope, or the like. The cooled fluid may be as cold as 4°C, but may also be at a higher temperature. In some configurations, the cooling rate of the cooled fluid may 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 the 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 may warm the anatomical site and increase the temperature at the corresponding 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 lower than body temperature. The risk of hypothermia is indicated by a specified time below a 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 a target anatomical temperature that is automatically managed. The system may maintain temperature by monitoring temperature sensor readings, pressure sensor readings, flow rate readings, and / or settings of the therapy delivery device. The system may measure and / or calculate the rise and fall in temperature resulting from administering a therapy of a certain duration at a particular setting, particular 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 drop 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 the more common rates of temperature change. Various fluid temperatures can be achieved by mixing refrigerated fluid with room temperature or heated fluid.
[0023] FIG. 1A illustrates, by way of example, a diagram of a system 100A for managing fluid temperature of 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 close 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 ultrasonic 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 ultrasonic 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 the control circuitry 142 via an electrical communication medium 140. The control circuitry 142 manages the temperature of the anatomical location 114 by adjusting one or more parameters associated with 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.), and the like.
[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 feeding, 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. A second end of the conduit 134, opposite thereto, can be positioned near the anatomical site 114. The conduit 134 can move through the scope 120 or can be permanently attached to or removably coupled to the scope 120. The conduit 134 transports fluid to the anatomical site 114 while protecting the fluid from the surrounding environment of 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 fibers, electrical conductors, or wireless communication medium) 136 permanently or removably attached thereto. A physician or other user may view the anatomical site 114 through the optical system on the scope 120 or through a display 224 (see FIG. 2). The physician or other user may enable, disable, or adjust the treatment provided by the energy delivery device 118 using control knobs, buttons, or control pedals, e.g., foot-activated, and / or other actuation mechanisms on or coupled to the scope 120. Additionally or alternatively, the physician may control the energy delivery device 118 via a separate control system (e.g., a laser console touch screen display). The procedure of viewing inside the patient's body is called endoscopy. The scope 120 may be used to examine internal organs such as the throat, paranasal sinuses, ureters, kidneys, and esophagus. Endoscopes may be specialized to view target organs, etc. Such specialized endoscopes are sometimes named after the organs they are intended to view. For example, a sinusoscope is specialized to provide a view of the paranasal sinuses, an otoscope is specialized to provide a view of the inner ear, a ureteroscope is specialized to provide a view of the ureters, a laryngoscope is specialized to provide a view of the larynx, a cystoscope is specialized to provide a view of the bladder, a nephroscope is specialized to view the kidneys, a bronchoscope is specialized to view the bronchi, an arthroscope is specialized to view the joints, a colonoscope is specialized to view the colon, and a laparoscope is specialized to view 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), a conductor such as a monopolar electrode or a bipolar electrode that can be coupled to (if the treatment device 118 includes a power source), etc. The treatment device 118 can generate energy that is transmitted to the anatomical site 114 by the communication medium 136. The energy control system 116 can adjust the energy delivery device 118 to adjust the energy provided to the anatomical site 114 by the energy delivery device 118 and the communication medium 136. The energy control system 116 can adjust the operating parameters of the energy delivery device 118. Examples of operating parameters include the intensity, frequency, duration of laser treatment, or other parameters. Examples of other operating parameters include the magnitude, amplitude, frequency, shape of electrical treatment, or other parameters. Examples of the energy control system 116 include a laser generator, a power generator, an ultrasonic generator, etc. These generators usually come with knobs, touchscreens, buttons, etc. that can be operated by the user. The user can adjust the output parameters of the generator by inputting via the touchscreen, pressing buttons, turning knobs, 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 the controller of the energy generation circuit). The input interface adjusts the energy generation circuit according to the input received at the input interface so that the controller can adjust the energy generation circuit according to the input, or provides the input to the controller (in the same format or a different format as the received one). The input can be provided by the user (turning a knob, touching the touchscreen, etc.), the control circuit 142, a device controlled by the user (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, may be physically separate from the scope 120, may be attached to the scope 120, may be 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 the laser energy is being delivered to the anatomical site 114. The 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] The 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.), and the like.
[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 circuitry 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 or default temperature). The second criterion may include the same or a different temperature threshold.
[0032] When the temperature data meets the third criterion, the control circuit 142 can increase the power provided by the energy control system 116. When the temperature data meets the third or a fourth different criterion, the control circuit 142 can reduce the flow rate of the fluid from the fluid reservoir 102. The third criterion may include that the temperature indicated by the temperature data is below a threshold temperature (e.g., a user-specified temperature or a default temperature). The fourth criterion may include the same or different temperature thresholds. Any of the threshold temperatures can be set based on the 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 around the anatomical site 114 does not reach 42°C. Such threshold temperatures can include 34°C, 35°C, 36°C, 37, 38, 39, 40, 41, 42, 43, 44, 45°C, or a temperature higher or lower than 42°C but less than 42°C. One or more of the threshold temperatures can be set to help ensure that the temperature of the tissue around the anatomical site 114 is maintained higher than the temperature corresponding to hypothermia. Hypothermia occurs when the body temperature is below 35°C. The lower threshold temperature can be about 32, 31, 30, 29, 28°C, for example, 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 in this specification such as in FIGS. 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 performs electromagnetic transmission to a receiving antenna. The electromagnetic transmission can comply with a communication protocol that defines a method of encoding data 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 spaces, etc., through which light can pass in a restricted manner.
[0034] 1B illustrates, 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 circuitry 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 be indicative of 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 be indicative of how much gas is being retained due to evaporation of fluid, 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 the energy delivered to the anatomical location 114. By controlling the pressure, the control circuitry 142 can help ensure that the 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 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 set point of the fluid in the fluid reservoir 102 based on temperature data from the temperature sensor 138, flow data from the flow sensor 148, pressure data from the pressure sensor 150, and / or any combination thereof.
[0038] 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 targeted 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 targeted anatomical site (e.g., on the proximal end of the scope 120).
[0039] The systems 100A, 100B assist a user of the scope 120 in maintaining the temperature of the anatomical site 114 (and the anatomical structures surrounding the anatomical site 114) below denaturation temperatures and / or above hypothermia-inducing temperatures. The systems 100A, 100B improve upon conventional irrigation systems that do not include feedback of temperature, pressure, or flow data to inform temperature management. The systems 100A, 100B can selectively, adaptively, and smartly adjust the temperature of the target site based on measured / calculated temperature, flow, pressure, or a combination thereof.
[0040] FIG. 2 shows, by way of example, a block diagram of another system 200 for managing the fluid temperature of fluid from fluid reservoir 102 provided to anatomical site 114. System 200 includes some 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 circuit 142, and communication media 136, 140, and 146. System 200 includes additional components including fluid cooler 228, display device 224, communication media 220, 222.
[0041] Conduit 230 provides a path for fluid to flow to fluid cooler 228. Fluid cooler 228 lowers the temperature of the fluid. Fluid cooler 228 can operate by evaporating a coolant (e.g., changing the coolant from a liquid state to a gaseous state), thereby cooling the area surrounding the coolant. Fluid cooler 228 can operate based on the Peltier effect. Such a cooler transfers 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. Thereby, the fluid in contact with the first portion of the object and the surrounding fluid are cooled. There are other types of cooling that can be used in these teachings, and the type of cooling provided is merely an example.
[0042] The mechanical coupling between conduit 134 and fluid cooler 228 can hold the first end of conduit 134 around the port of fluid cooler 228. The mechanical coupling can include a form fit, compression ring, or other mechanical coupling.
[0043] The control circuit 142 can provide a control signal over the communication medium 220 to the fluid cooler 228. 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 an increase in the temperature set point of the fluid cooler 228 (or turn off the cooling of the fluid cooler 228). 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 a decrease in the temperature set point of the fluid cooler 228.
[0044] The control circuitry 142 can provide display temperature data over the communication medium 222. The display temperature data can be provided to the display device 224. The display temperature data can include a measured or calculated temperature at the anatomical location 114, such as using the temperature sensor 138. The display temperature data can include other data related to the temperature of the anatomical location 114, such as a temperature set point of 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 the 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 thresholds, low temperature thresholds, 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, and the like. 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 a combination thereof at the anatomical site 114 is approaching, equaling, or meeting a criterion, the user interface 226 may provide an alert to the user. The alert may be displayed visually using the interface 226. For example, the visual alert may include a picture, a 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 predefined 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 alerts may be used to indicate that the temperature data, pressure data, flow data, or a combination thereof indicates that the temperature, pressure, or a combination thereof is approaching, equaling, or other specified criterion is being met. The display of temperature data, pressure data, flow rate data, or a combination thereof, may allow 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 better maintain the temperature of the anatomical site 114 within predetermined limits. The user interface 226 may provide a view, audio, haptic feedback, etc. of the proposed adjustments that, if approved by the user via the user interface 226, are automatically implemented by the control circuitry 142. In some embodiments, the control circuitry 142 may automatically implement the proposed adjustments after a specified time has elapsed or without any delay. The user may define a tolerance range within which the system 200 (or other system) may make automatic adjustments to the energy control system 116, the fluid reservoir 102, or the fluid cooler 228.For example, the system 200 can be made to automatically adjust the energy control system 116 to deliver up to 20 W of energy, a pulse frequency of 20 Hz, and a water pressure of 150 mm, such that the user attempts to maintain the temperature around the anatomical site 114 below 42°C. Since these approved system operating ranges can be set by the user, the user can reduce the frequency with which they need to respond to system warnings and suggestions during patient treatment.
[0047] The system 200 enhances cooling control, such as when the energy delivery device 118 supplies energy at a rate that causes temperature changes that cannot be managed with uncooled fluid. The system 200 can enable the user to operate the energy delivery device 118 at the anatomical site 114 for a longer duration than would be possible if the user did not actively cool the fluid. Using room temperature fluid, or other fluid whose temperature is not actively managed, reduces the control accuracy of the temperature at the anatomical site 114. By using the fluid cooler 228, the user can operate the energy delivery device 118 for an extended period without raising the temperature beyond the denaturation temperature of the room temperature fluid. This enables the user to provide treatment more continuously without having to pause and wait for the temperature at and around the anatomical site 114 to drop to a temperature that does not endanger the tissue surrounding the anatomical site 114.
[0048] FIG. 3 shows, by way of example, a block diagram of another system 300 for managing the fluid temperature of the fluid provided to the anatomical site 114. The system 300 includes some of the components of system 100A, 100B, or 200, including a fluid reservoir 102, a conduit 134, a scope 120, an energy control system 116, an energy delivery device 118, a temperature sensor 138, a control circuit 142, a display device 224, a fluid cooler 228, and communication media 136, 140, 146, 220, 222. The 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] The suction device 330 removes fluids and debris from the anatomical site 114. The suction device 330 can generate a negative air pressure that causes the fluids and debris to flow through a conduit 332 and into a waste container 334. The suction device 330 can be integrally formed with the scope 120, physically separate from the scope 120, attached to the scope 120, removably coupled to the scope 120, etc. The suction device 330 helps remove warm fluids and debris from the anatomical site 114, thus helping to maintain the ambient temperature of the 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 a 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 may provide temperature data to the control circuitry 142 via the communication medium 340. The control circuitry 142 may 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 may be lower than the temperature of the anatomical site 114. The temperature from the temperature sensor 338 may 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 may be empirically determined and / or theoretically calculated prior to the therapeutic procedure.
[0052] The flow sensor 336 may be 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 the 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 a 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 rate 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 changing the temperature of the anatomical site 114. The control circuit 142 may vary the temperature set point of the fluid cooler 228 based on temperature data from the temperature sensor 338, flow 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, temperature, or other data provided to the control circuitry 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 fluid temperature of a mixed fluid delivered to an anatomical site 114 or pressure at an 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 of 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] The fluid reservoir 440 may be the same source as the fluid reservoir 102 or a different source. The fluid in the fluid reservoir 440 may be saline or another fluid. The fluid from the fluid reservoir 440 may travel through a conduit 442 to an actuated valve 444. The temperature of the fluid from the 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 the anatomical site 114.
[0056] The actuated 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 actuated valve 444. The actuated 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 of 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 actuated valve 444 and ultimately to the anatomical site 114. The actuated valve includes a valve actuator that uses a power source coupled to a mechanically coupled motor of the actuated valve 444 to operate the valve. The power source can be electric, pneumatic, or hydraulic. The actuated 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 of 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 of the actuated valve 444. The control circuit 142 can adjust the opening of the orifices of 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 of the actuating 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 site 114. For example, there may be two separate orifices (or valves) respectively associated with the direct fluid and the cooled fluid. By adjusting the state (e.g., the size or opening degree of the 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 related to the anatomical site 114, the length of the conduit 134 between the valve 444 and the anatomical site 114, or a combination thereof. The temperature of the anatomical site 114 can be compensated considering the heating or cooling occurring along the length of the conduit 134, such as by the energy delivered by the energy delivery device 118, the air flow provided by the suction device 330, or a combination thereof. The temperature of the mixed fluid can be adjusted so that the temperature of the anatomical site 114 is reliably maintained within a user-specified (or default) allowable temperature range.
[0059] The temperature sensor 446 may be on or at least partially within the actuating valve 444. The temperature sensor 446 can provide temperature data indicating the temperature of the mixed fluid within the actuating valve 444. The temperature data can be provided to the control circuit 142 using the communication medium 458.
[0060] The conduit 448 can provide the mixed fluid from the actuating valve 444 to the pump 450. The pump 450 can include a peristaltic pump or a 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 for adjusting the pump speed of the pump 450 on the communication medium 460.
[0061] The flow sensor 452 can provide flow data to the control circuitry 142 over the communication medium 462. The flow data can indicate how much fluid is passing through the conduit 134 per unit time. The control circuitry 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 be indicative of 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 be indicative of how much gas is being retained due to evaporation of fluid, 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 the energy delivered to the anatomical site 114. By controlling the pressure, the control circuitry 142 can help ensure that the energy delivery is effective and safe.
[0063] The user interface 226 (see FIGS. 2 and 3) may provide a view of temperature data from the temperature sensor 446, the state of the actuation valve 444 (how open or closed the valve is), the pumping speed of the pump 450, the flow rate of the mixed fluid in the conduit 134, pressure data from the pressure sensor 150, or a combination thereof. The data provided on the user interface 226 may provide a user with better information about the status and effectiveness of the energy delivery.
[0064] FIG. 5 illustrates, by way of example, a block diagram of a system 500 for managing fluid temperature of a mixed fluid provided to an anatomical site 114. System 500 includes 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, direct fluid from fluid reservoir 440, and heated fluid from fluid heater 554. Although 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 provided to actuated 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 of 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., the size or 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 can provide data indicative of a temperature setpoint or another temperature setpoint of the fluid heater 554. A user can 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 settings of the energy control system 116 (e.g., joules per pulse, watts, etc.), the control circuit 142 can monitor the amount of energy going to and from the anatomical site 114. Equation (1) shows 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 entering and leaving the surgical space at the same instant (e.g., in cubic centimeters), and T inflow where t is the temperature of the fluid entering the anatomical site 114 and T is the average temperature of the irrigation fluid at that instant in 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 use equation (1) to 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.
[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) indicating that a threshold has been violated, which threshold has been violated, or a combination thereof. The display can provide a visual alert indicating that a threshold has been violated, which threshold has been violated, or a combination thereof.
[0074] 6 illustrates, 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 light 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 providing, by the control circuit, a control signal to titrate 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 manage the temperature of the anatomical site toward a desired target temperature.
[0075] The method 600 may further include removing fluid from the anatomical site with a suction device and providing the removed fluid. The method 600 may 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 may be the temperature of the removed fluid or the temperature of the fluid at the anatomical site.
[0076] Method 600 may further include cooling a first portion of the fluid with a fluid cooler to provide a cooled fluid. Method 600 may further include providing the cooled fluid through a second conduit. Method 600 may further include adjusting, by the control circuitry, 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 result in 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 circuitry, 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, via 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 combinations 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 may set the operating parameters).
[0081] The temperature data 772 may include data from any of the temperature sensors of 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 of the fluid cooler 228, the fluid heater 554, or a combination thereof.
[0082] The pressure data 774 may indicate a measured pressure at the anatomical location 114. The pressure data 774 may indicate 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 flows 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 aspirator 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 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 in determining the pressure at operation 778.
[0085] The temperature may be determined based on pressure data 774, temperature data 772, flow 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 in 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 the system 100A, 100B, 200, 300, 400, or 500 to regulate a temperature of the anatomical site 114. The method 800 may be performed, at least in part, by the 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 data 776, energy data 770, or combinations thereof (see FIG. 7). The 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, e.g., positive, another specified threshold, combinations 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 set point of the fluid heater 554, lowering the temperature set point 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 combinations 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 combinations 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.
[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 particular threshold temperature, a rate of change of a negative temperature, e.g., having a magnitude greater than another particular 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 site 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) decreasing the amount of fluid provided to the anatomical site 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 site 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 higher than the ambient temperature, which may act to lower the temperature at the anatomical site 114.
[0091] There are many relationships that can be derived from measurements of flow, temperature, time, pressure, or combinations thereof. One such relationship can include 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 regarding the rate of change and time until the threshold is exceeded so that the user can make the appropriate decision as to 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 the system 100A, 100B, 200, 300, 400, or 500 to regulate pressure at the anatomical site 114. The method 900 may be performed, at least in part, by the control circuitry 142. The illustrated method 900 includes receiving data at operation 990. The received data may include any of the pressure data 774, temperature data 772, flow data 776, energy data 770, or combinations thereof (see FIG. 7). The 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 at 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, combinations 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, lowering the temperature set point of the fluid heater 554, lowering the temperature set point of the fluid cooler 228, reducing the opening of an orifice of an actuated valve 444 that supplies heated fluid or increasing the opening of an orifice of an actuated valve 444 that provides 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 that provides 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 the systems 100A, 100B, 200, 300, 400, 500 can maintain the temperature of the anatomical site 114 near a specified temperature (e.g., 37° C. / normal body temperature), such as while performing one or more of the methods 600, 700, 800, or 900, which allows the 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, the teachings provide a 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 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 a system may include a valve, allowing room temperature saline, chilled saline, and / or heated saline as one or more inputs to the valve to precisely control the temperature of the irrigation fluid. Feedback temperature from the anatomical site, excess fluid, etc. may provide temperature and flow rate information to logic to determine how to control the valve and irrigation pump.
[0096] 10 illustrates, 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. The machine 1000 can perform a method for temperature management of an anatomical site, such as methods 600, 700, 800, 900, portions thereof, or a combination in whole or in part. The control circuitry 142, the energy control system 116, the energy delivery device 118, the scope 120, the temperature sensor 138, the fluid cooler 228, the display 224, the flow sensor 336, the temperature sensor 338, the actuated valve 444, the pump 450, the flow sensor 452, the temperature sensor 446, the pressure sensor 150, the fluid heater 554, or a combination thereof, may comprise one or more components of the machine 1000.
[0097] The example machine 1000 (in the form of a computer) may include a processing unit 1002, a memory 1003, a removable storage device 1010, and a non-removable storage device 1012. Although an exemplary computing device is shown and described as machine 1000, the computing device may be in 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 over a network such as the Internet.
[0098] The memory 1003 may include volatile memory 1014 and non-volatile memory 1008. The machine 1000 may include or have access to a computing environment that includes a variety of computer readable media, such as volatile memory 1014 and non-volatile 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 disk read only memory (CD ROM), digital versatile disk (DVD) or other optical disk storage, magnetic cassette, magnetic tape, magnetic disk storage, or other magnetic storage capable of storing computer readable instructions for performing the functions described herein.
[0099] The machine 1000 includes or can access 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 touch screen that also functions as an input device. The input 1006 may include one or more of a touch screen, a touch pad, 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 network environment using the communication connection and can connect to one or more remote computers, such as a cloud-based server or a database server including storage. The remote computers may include a personal computer (PC), a server, a router, a network PC, a peer device or other common network node, and the like. The communication connection may include a local area network (LAN), a wide area network (WAN), a 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 processor 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, the computer program 1018 can be used to cause the processor 1002 to execute 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 a control circuit electrically coupled to receive the first temperature data, the control circuit 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 may further include the components of Example 1, including an aspiration device configured to remove fluid from the anatomical site and provide the removed fluid, and a second irrigation conduit in fluid communication with the aspiration device and configured to receive the removed fluid and transport the removed fluid from the anatomical site, where 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 a fourth temperature to which the fluid cooler cools the cooled fluid based on the first temperature data.
[0105] In Example 5, the embodiment 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, 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, and the control circuit being 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 is 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 circuitry and positioned to generate pressure data representative of pressure around the anatomical site, the control circuitry further configured to adjust a pump 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 arranged 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 a speed of the pump based on the flow rate.
[0112] In Example 12, at least one of Examples 1-11 may further include, wherein the control circuitry is configured to adjust settings of the energy delivery device to manage a 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 may 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 further includes providing a user interface, where the display is configured to receive data indicating a first temperature set point above which to maintain the anatomical site and a second temperature set point 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 set point and the second temperature set point.
[0116] Example 16 includes a method including the steps of providing light or electrical energy to an anatomical site; providing a 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 may further include the steps of removing fluid from the anatomical site by a suction device to provide removed fluid, and transporting the removed fluid to a waste container by 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 is 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 provide the 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 provide 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 a control circuit electrically coupled to the first temperature sensor, the control circuit configured to receive the first temperature data and provide a control signal to adjust a state of the at least one actuated valve, a temperature setting, or a combination thereof to manage a temperature of the anatomical site.
[0122] The foregoing description and drawings sufficiently illustrate particular embodiments to enable one 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. The 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. Although 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 included 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, and such embodiments of the inventive subject matter may be referred to herein, individually or collectively, in the term "invention" for convenience only, and 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 shown herein are described in sufficient detail to enable those skilled in the art to practice the disclosed teachings. Other embodiments can be used and derived therefrom, such that structural and logical substitutions and changes can be made without departing from the scope of the disclosure. Therefore, the detailed description should not be construed in a limiting sense, and the scope of the 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. Additionally, 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 certain operations are illustrated in the context of certain exemplary configurations. Other allocations of functionality are contemplated and may be within the scope of various embodiments of the disclosure. In general, structures and functions shown as separate resources in an example configuration may be implemented as a combined structure or resource. Similarly, structures and functions shown 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 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 above description has been set forth with reference to specific exemplary embodiments for purposes of illustration. However, the above exemplary discussion is not intended to be exhaustive or to limit the possible exemplary embodiments to the precise forms disclosed. Many modifications and variations are possible in light of the above teachings. The exemplary embodiments have been 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 terms used in the description of the exemplary embodiments herein are intended only to describe the particular exemplary embodiment and are not intended to be limiting. When used in the description of the 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 possible combination of one or more of the associated listed items. It will also 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] The term "when" as used herein can be interpreted to mean "when," "in the event," "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 determining" 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, treatment 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 Container 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 first temperature sensor positioned to provide first temperature data associated with the anatomical site; a control circuit electrically coupled to receive the first temperature data, the control circuit 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 at the anatomical site based at least in part on the first temperature data; and Equipped with The therapeutic delivery system comprises: a pump in fluid communication with the first irrigation conduit and electrically coupled to the control circuit; a pressure sensor electrically coupled to the control circuitry and positioned to generate pressure data representative of pressure surrounding the anatomical location; Further equipped with The control circuitry is further configured to adjust a pumping speed of the pump based on the pressure data; the control circuitry is configured to modify a temperature set point of the fluid based on the first temperature data from the first temperature sensor, the pressure data from the pressure sensor, and / or any combination thereof. Therapeutic delivery systems.
2. a suction device configured to remove fluid from the anatomical site and provide removed fluid; a second irrigation conduit in fluid communication with the suction device to receive the removed fluid and configured to transport the removed fluid from the anatomical site; Further equipped with the first temperature data is a third temperature of the removed fluid; The system of claim 1.
3. the first temperature data includes the second temperature; The system of claim 1.
4. a fluid cooler in fluid communication with the fluid, the fluid cooler configured to receive and cool a first portion of the fluid to obtain a cooled fluid; the control circuit adjusts a fourth temperature to which the fluid cooler cools the cooled fluid based on the first temperature data. The system of claim 1.
5. 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 4.
6. a fluid heater in fluid communication with the fluid, the fluid heater being 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. The system of claim 4.
7. 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 control circuit is configured to change the opening degree of the actuation valve based on the first temperature data. The system of claim 6.
8. a second temperature sensor positioned to determine a fifth temperature of the fluid from the actuated valve; The control circuitry is further configured to adjust temperature settings of each of the fluid heater and the fluid cooler based on the fifth temperature. The system of claim 7.
9. a flow sensor disposed to determine a flow rate of fluid from the pump and electrically coupled to the control circuit; The control circuitry is further configured to adjust the speed of the pump based on the flow rate. The system of claim 1 .
10. the control circuitry is configured to adjust settings of the energy delivery device to manage a temperature of the anatomical site based on the first temperature data. The system of claim 1.
11. a display electrically coupled to the control circuitry and configured to provide a view of the first temperature to a user. The system of claim 1.
12. and an alarm configured to generate audio, visual, or tactile feedback indicating that the first temperature has exceeded or is about to exceed a threshold temperature. The system of claim 11.
13. the display device provides a user interface configured to receive data indicative of a first temperature set point above which to maintain the anatomical site and a second temperature set point below which to maintain the anatomical site, and the control circuitry automatically operates to manage a temperature of the anatomical site between the first temperature set point and the second temperature set point. The system of claim 11.
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