Fluid management system with integrated laser fiber cooling

Abstract

To provide a medical system.SOLUTION: The medical system may include: a medical device including an elongate shaft configured to access a treatment site within a patient and a handle coupled to a proximal end of the elongate shaft; a laser device including an elongate tubular member configured for insertion through a working lumen of the medical device, the elongate tubular member including a cooling channel and a laser fiber extending distally within the cooling channel; and a fluid management system including an inflow pump configured to pump fluid from a first fluid supply source through the elongate shaft to the treatment site, a cooling pump configured to pump fluid from a second fluid supply source through the cooling channel, and a controller configured to control the inflow pump and the cooling pump.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] 〔Cross - Reference to Related Applications〕 This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 058,687, filed Jul. 30, 2020, the disclosure of which is incorporated herein by reference.

[0002] The disclosure of the present invention relates to a fluid management system. More specifically, the disclosure of the present invention relates to systems and methods for cooling a laser fiber using a fluid management system.

Background Art

[0003] In flexible ureteroscopy (fURS), gynecological surgery, and other endoscopic procedures, liquid circulation is required for several reasons. Today's surgeons deliver fluid in various ways, such as by hanging a fluid bag and using gravity to deliver the fluid, filling a syringe and manually injecting the fluid, or using a peristaltic pump to deliver fluid from a reservoir at a fixed pressure or flow rate through a fluid management system. The fluid management system can adjust the flow rate and / or pressure at which fluid is delivered from the reservoir based on data collected from a procedure device such as an endoscope. Among known medical devices, systems, and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and fluid delivery systems.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0005] In the first example, the medical system may include a medical device comprising an elongated shaft configured to access a treatment site within a patient and a handle coupled to the proximal end of the elongated shaft; a laser device comprising an elongated tubular member configured for insertion through the working lumen of the medical device, the elongated tubular member comprising a cooling channel and a laser fiber extending distally within the cooling channel; and a fluid management system comprising an inlet pump configured to pump fluid from a first fluid source through the elongated shaft to the treatment site, a cooling pump configured to pump fluid from a second fluid source through the cooling channel, and a controller configured to control the inlet pump and the cooling pump.

[0006] In addition to or in lieu of any examples disclosed herein, a cooling pump is a peristaltic pump.

[0007] In addition to or in lieu of any examples disclosed herein, the cooling pump is a diaphragm pump.

[0008] In addition to or in lieu of any examples disclosed herein, the cooling pump is a positive displacement pump.

[0009] In addition to or in lieu of any examples disclosed herein, the cooling pump includes a disposable, single-use pump head.

[0010] In addition to or in lieu of any examples disclosed herein, the fluid management system includes a pressure sensor positioned between the cooling pump and the distal end of the cooling channel.

[0011] In addition to or in lieu of any examples disclosed herein, the fluid management system includes a pressure sensor positioned between a second fluid source and a cooling pump.

[0012] In addition to or in lieu of any examples disclosed herein, the cooling pump is configured to pump fluid through the cooling channel at a fluid flow rate between 0 mL / min and 100 mL / min.

[0013] In addition to or in lieu of any examples disclosed herein, the cooling pump is configured to pump fluid through the cooling channel at a fluid pressure between 0 mmHg and 500 mmHg.

[0014] In addition to or in lieu of any examples disclosed herein, and in the second example, a medical system may include a medical device comprising an elongated shaft configured to access a treatment site in a patient and a handle coupled to the proximal end of the elongated shaft; a laser device comprising an elongated tubular member configured for insertion through the working lumen of the medical device, the elongated tubular member comprising a cooling channel and a laser fiber extending distally within the cooling channel; and a fluid management system comprising an inlet pump configured to pump fluid from a first fluid source through the elongated shaft to the treatment site, a cooling pump configured to pump fluid from a second fluid source through the cooling channel, and a controller configured to control the inlet pump and the cooling pump. The laser device may include a laser controller that electronically communicates with the controller of the fluid management system.

[0015] In addition to or instead of any examples disclosed herein, when the laser controller increases the laser power, the controller of the fluid management system increases the speed of the cooling pump.

[0016] In addition to or instead of any examples disclosed herein, when the laser controller terminates the laser power, the controller of the fluid management system stops the cooling pump.

[0017] In addition to or in lieu of any examples disclosed herein, the laser controller delays the activation of the laser power until after the controller of the fluid management system has activated the cooling pump.

[0018] In addition to or in lieu of any examples disclosed herein, the laser controller monitors the temperature of the distal end of the laser fiber and instructs the controller of the fluid management system to increase the cooling pump speed if the temperature exceeds a predetermined limit.

[0019] In addition to or in lieu of any examples disclosed herein, and in a third example, a medical system may include a medical device comprising an elongated shaft configured to access a treatment site in a patient and a handle coupled to the proximal end of the elongated shaft; a laser device comprising an elongated tubular member configured for insertion through the working lumen of the medical device, the elongated tubular member comprising a cooling channel and a laser fiber extending distally within the cooling channel such that the cooling channel surrounds the laser fiber; and a fluid management system comprising an inlet pump configured to pump fluid from a first fluid source through the elongated shaft to the treatment site, a cooling pump configured to pump fluid from a second fluid source through the cooling channel, and a controller configured to control the inlet pump and the cooling pump. The laser device may include a laser controller that electronically communicates with the controller of the fluid management system.

[0020] In addition to or in lieu of any examples disclosed herein, the cooling channel terminates at a distal port adjacent to the distal end of the elongated tubular member.

[0021] In addition to or in lieu of any examples disclosed herein, the laser energy exits the elongated tubular member through the distal port.

[0022] In addition to or in lieu of any examples disclosed herein, the laser device includes a handle portion at the proximal end of an elongated tubular member, the handle portion being configured to rotate the elongated tubular member.

[0023] In addition to or instead of any examples disclosed herein, the controller of the fluid management system is configured to control the cooling pump based on a set of system operating parameters to maintain a target fluid flow rate through the cooling channel.

[0024] In addition to or instead of any examples disclosed herein, the controller of the fluid management system is configured to control the cooling pump based on a set of system operating parameters to maintain a target fluid pressure through the cooling channel.

[0025] The above summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or all implementations of the disclosure of the present invention. The drawings and the detailed description that follows more specifically illustrate these embodiments.

[0026] The present invention can be more fully understood by considering the following detailed description in connection with the accompanying drawings.

Brief Description of the Drawings

[0027] [Figure 1] It is a schematic diagram showing a selected aspect of the fluid management system. [Figure 2] It is a partial perspective view showing a selected aspect of the fluid management system of FIG. 1. [Figure 3] It is a schematic diagram showing a selected aspect of the laser ablation system. [Figure 4] It is a partial cross-sectional view of a part of the laser ablator of FIG. 3. [Figure 5] It is a view showing a selected aspect of the laser ablation system of FIG. 3.

[0028] While the present invention is susceptible to various modifications and substitutions, its specific details are illustrated in the figures as an example and described in detail. However, it should be understood that the intention is not to limit it to specific embodiments that describe particular aspects of the present invention. On the contrary, the intention is to encompass all modifications, equivalents, and substitutions that fall within the spirit and scope of the present invention. [Modes for carrying out the invention]

[0029] The following description should be read with reference to drawings that are not necessarily to scale, and similar reference numbers indicate similar elements throughout some of the drawings. The detailed description and drawings are intended to illustrate the claimed invention, but not to limit it. Those skilled in the art will recognize that various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the disclosure of the invention. The detailed description and drawings illustrate exemplary embodiments of the claimed invention. However, for the purpose of clarity and ease of understanding, not all features and / or elements can be shown in each drawing, but features and / or elements can be understood to exist nevertheless unless specifically noted.

[0030] With respect to the terms defined below, unless otherwise specified in the claims or elsewhere in this specification, these definitions shall apply.

[0031] In this specification, all numerical values ​​are assumed to be modified by the term “approximately,” whether expressly indicated or not. In relation to numerical values, the term “approximately” refers to a range of numerical values ​​that a person skilled in the art would generally consider equivalent to the value mentioned (e.g., having the same function or result). In many cases, the term “approximately” can include a number rounded to the nearest significant figure. Any other use of the term “approximately” (e.g., in a non-numerical context) can be assumed to be understood in relation to this specification and to have a common and customary definition consistent with that context, unless otherwise noted.

[0032] Numerical ranges specified by endpoints include all numbers within that range, including the endpoint (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0033] While some appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art, inspired by the disclosures of the present invention, will understand that desirable dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0034] In this specification and in the claims, the singular forms “a,” “an,” and “the” are accompanied by plural reference terms unless the context is clearly different. In this specification and in the claims, the term “or” is generally used to include “and / or” unless the context is clearly indicated otherwise. For ease of understanding, it should be noted that certain features of the disclosure of the present invention may be described in the singular form, even if they are plural or repeated in the embodiments disclosing those features. Each example of a feature may include a singular disclosure and / or be encompassed by a singular disclosure unless expressly opposed. For the purposes of simplification and clarity, not all elements of the disclosed invention are necessarily shown in each figure or described in detail below. However, it should be understood that the following descriptions may apply equally to any and / or all of the components that exist in greater than one form unless expressly opposed. Furthermore, not all examples of some elements or features may be shown in each figure for clarity.

[0035] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations can be generally understood in relation to the positioning, orientation, and / or operation of various elements of a device relative to the user / operator / manipulator. “Proximal” and “backward” indicate or point towards or closer to the user, while “distal” and “forward” indicate or point towards or further away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of the disclosures of the present invention, and such cases will be readily apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen, such as a body cavity, blood vessel, or within a device.

[0036] The term “range” can be understood to mean the maximum measurement of a described or identified dimension unless such range or dimension precedes or is identified as “minimum,” which can be understood to mean the minimum measurement of the described or identified dimension. For example, “outer range” can be understood to mean the outer dimension, “radial range” can be understood to mean the radial dimension, “longitudinal range” can be understood to mean the longitudinal dimension, and so on. Each instance of “range” can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), which will be apparent to those skilled in the art from the context of the individual uses. Generally, “range” can be considered the maximum possible dimension measured according to the intended use, while “minimum range” can be considered the minimum possible dimension measured according to the intended use. In some cases, “range” can generally be measured orthogonally in a plane and / or cross-section, but as will be apparent from the specific context, it can also be measured in different ways, such as angularly, radially, circumferentially (e.g., along an arc), for example, but not limited to the following.

[0037] The terms “monolithic” and “single” generally refer to one or more elements made from or composed of a single structure or basic unit / element. Monolithic and / or single elements exclude structures and / or features created by assembling or otherwise combining multiple individual elements.

[0038] References to “embodiments,” “some embodiments,” and “other embodiments” in this specification should be noted as meaning that while the embodiments described may possess certain features, structures, or characteristics, not all embodiments may necessarily possess those features, structures, or characteristics. Furthermore, such expressions do not necessarily refer to the same embodiment. Moreover, where certain features, structures, or characteristics are described in relation to an embodiment, unless the opposite is explicitly stated, it is considered that performing those features, structures, or characteristics in relation to other embodiments, whether explicitly described or not, is within the scope of the knowledge of those skilled in the art. That is, the various individual elements described below, even if not explicitly stated in any particular combination, are nevertheless considered combinatorial or configurable to form yet another embodiment or to complement and / or enhance the embodiments described, as will be understood by those skilled in the art.

[0039] With regard to clarity, numerical nomenclature for specific identification (e.g., first, second, third, fourth, etc.) can be used to name and / or distinguish various descriptive and / or claim features throughout the description and / or claims. It should be understood that numerical nomenclature is not intended to be limiting and is illustrative. In some embodiments, changes and deviations from previously used numerical nomenclature can be made for brevity and clarity. That is, a feature identified as the “first” element may later be called the “second” element, the “third” element, and so on, or may be omitted entirely, and / or a different feature may be called the “first” element. The meaning and / or designation in each case will be obvious to those skilled in the art.

[0040] Some fluid management systems used in flexible ureteroscopy (fURS) procedures (e.g., ureteroscopy, percutaneous nephrolithotomy (PCNL), benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP)), gynecological, and other endoscopic procedures can regulate cavity pressure when used with endoscopic devices such as, but not limited to, LithoVue® scope devices, using pressure and / or temperature data from the endoscope or other endoscopic devices. By directly regulating cavity pressure during a medical procedure, the fluid management system can safely drive system pressures up to 600 mmHg to ensure no flow loss during the procedure when a tool is inserted into the working channel of the endoscopic device. Fluid shortages can be a concern for physicians, for example, during procedures that are long and / or use large volumes of fluid. Excessive fluid absorption by the patient can lead to complications such as edema / water intoxication and / or sepsis during BPH / TURP in high-pressure and / or high-volume cases. Determining a satisfactory amount of fluid loss (e.g., fluid depletion) can be difficult because it can vary depending on the patient and procedure. Furthermore, tracking the amount of fluid injected can be difficult because multiple fluid sources (e.g., saline bags, glycine, etc.) can be used during a procedure. Fluid depletion can also be difficult to calculate because it relies on the waste recovery system, and fluid lost outside the recovery system (e.g., on the floor) may not be included in the calculation. As a result, in some procedures, fluid depletion may be estimated and inaccurate. Systems and methods to automate and / or improve the accuracy of fluid depletion calculation and / or monitoring are desired.

[0041] Figure 1 is a schematic perspective view of a fluid management system 10 that can be used in endoscopic procedures such as the fURS procedure. The fluid management system 10 can enable the flow of fluid through the fluid management system and can be coupled to a medical device 20 including a pressure sensor. The exemplary medical device 20 may be a LithoVue® scope device or another endoscope. In exemplary embodiments, the medical device 20 may include a temperature sensor that provides intra-cavitary temperature feedback to the fluid management system 10, a pressure sensor that provides intra-cavitary pressure feedback to the fluid management system 10, and / or a camera that provides visual feedback to the fluid management system 10.

[0042] The fluid management system 10 may include an inflow pump 50 configured to pump and / or transfer fluid from a first fluid source 34 (e.g., a fluid bag) to a medical device 20 and / or treatment site. In some embodiments, the first fluid source 34 may comprise a plurality of first fluid sources (e.g., a plurality of fluid bags). In some cases, the fluid may pass through a fluid heating system 60 before entering the medical device 20. Fluid flow, fluid pressure, fluid temperature, and other operating parameters may be controlled by a controller 30, or at least partially controlled by the controller 30. The controller 30 may communicate electronically (e.g., wired or wirelessly) with the medical device 20, the inflow pump 50, and / or the fluid heating system 60 to supply control commands and / or transfer or receive data in the process. For example, the controller 30 may receive data from the medical device 20, such as but not limited to pressure and temperature data. In some embodiments, the controller 30 can subsequently use data received from the medical device 20 to control the operating parameters of the inflow pump 50 and / or the fluid heating system 60. In some embodiments, the controller can be configured to control the inflow pump 50 based on a set of system operating parameters to maintain a target fluid flow rate or target fluid pressure. In some embodiments, the controller 30 can be configured to control the inflow pump 50 based on a set of system operating parameters to maintain a desired fluid pressure or desired flow rate at the treatment site.

[0043] The fluid management system 10 also comprises a fluid management unit. An exemplary fluid management unit may comprise one or more fluid container supports, such as fluid source hangers 32, each of which supports a first fluid source 34. In some embodiments, the arrangement and / or weight of the first fluid source 34 can be detected using remote sensors and / or supply load cells 94 associated with and / or operatively coupled to each fluid source hanger 32 and / or fluid container support. The controller 30 can electronically communicate with the supply load cells 94. The fluid source hangers 32 may be configured to accept first fluid sources 34 of various sizes, such as fluid bags ranging from 1 liter (L) to 5 liters. It will be understood that any number of fluid sources 34 can be used. Furthermore, first fluid sources 34 of any size can be used procedurally. In some embodiments, the fluid management unit may be mounted on a rolling stand which may comprise a pole 36 and / or a base 38. The base 38 may comprise multiple wheels to facilitate the movement of the fluid management unit during use. However, it will be understood that the first fluid supply source 34 may also be suspended from the ceiling or other locations, depending on clinical preference. The fluid supply source hanger 32 may extend from the pole 36 and / or controller 30 and may be equipped with one or more hooks from which one or more fluid supply sources 34 can be suspended. In some embodiments, the fluid used in the fluid management unit may be 0.9% saline solution. However, it will be understood that a variety of other fluids with different viscosities may be used, depending on the procedure.

[0044] In some embodiments, the fluid management unit may comprise a vacuum pump 24 and a recovery container 26 that is in fluid communication with a recovery drape 28. In some embodiments, the vacuum pump 24 may comprise multiple vacuum pumps. In some embodiments, the recovery container 26 may comprise multiple containers, canisters, and / or other receptacles, which can be fluidly connected to each other and / or to the vacuum pump 24. In some embodiments, the recovery drape 28 may comprise multiple recovery drapes. The vacuum pump 24 may be operatively and / or electronically connected to a controller 30. In some embodiments, the vacuum pump 24 may be positioned adjacent to and / or near the recovery container 26, as shown in Figure 1. In some embodiments, the vacuum pump 24 may be positioned within the fluid management system 10. Other configurations are also conceivable. In some embodiments, the recovery container 26 may be operatively coupled to a recovery load cell 25 to detect the position and / or weight of the recovery container 26. In embodiments having multiple containers, canisters, and / or other receptacles, each container, canister, and / or receptacle can be operationally coupled to a corresponding recovery load cell 25. The controller 30 can communicate electronically with the recovery load cell 25.

[0045] The fluid management system 10 may also include one or more user interface components, such as a touchscreen interface 42. The touchscreen interface 42 may include a display screen 44 and may have switches or knobs in addition to touch functionality. In some embodiments, the controller 30 may include the touchscreen interface 42 and / or the display screen 44. The touchscreen interface 42 allows the user to input / adjust various functions of the fluid management system 10, such as flow rate, pressure, or temperature. The user may also include parameters (e.g., maximum pressure alarms, etc.) and alarms, displayed information, and procedure modes. The touchscreen interface 42 allows the user to add, modify, and / or discontinue the use of various modular systems within the fluid management system 10. The touchscreen interface 42 can also be used to switch the fluid management system 10 between automatic and manual modes for various procedures. Other systems configured to accept user input, such as voice commands, etc., are intended to be used instead of or in addition to the touchscreen interface 42.

[0046] The touchscreen interface 42 can be configured to include selectable areas such as buttons and / or to provide functionality similar to physical buttons as understood by those skilled in the art. The display screen 44 can be configured to show icons related to modular systems and devices included in the fluid management system 10. The display screen 44 can also include a flow rate display. In some embodiments, operating parameters can be adjusted by touching the corresponding portion of the touchscreen interface 42. The touchscreen interface 42 can also display visual warnings and / or audible alarms when parameters (e.g., flow rate, temperature) exceed or fall below predetermined thresholds and / or ranges. In some embodiments, the fluid management system 10 can also include yet another user interface component, such as an optional foot pedal 46, a heater user interface, a fluid control interface, or other devices for manually controlling various modular systems. For example, an optional foot pedal 46 can be used to manually control the flow rate. Some exemplary display screens 44 and other user interface components are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled “Automated Fluid Management System,” published by the same applicant as this application, the entire disclosure of which is incorporated herein by reference.

[0047] The touchscreen interface 42 can be operationally connected to the controller 30 or can be part of the controller 30. The controller 30 can be a computer, tablet computer, or other processing device. The controller 30 can be operationally connected to one or more system components, such as an inflow pump 50, a fluid heating system 60, and a fluid shortage management system. In some embodiments, these functions can be integrated into a single unit. The controller 30 can perform and is configured to perform a variety of functions, such as calculation, control, arithmetic, and display. The controller 30 can also track and store data related to the operation of the fluid management system 10 and its components. In some embodiments, the controller 30 can include wired and / or wireless network communication capabilities, such as Ethernet or Wi-Fi, through which the controller 30 can connect to a local area network, for example. The controller 30 can also receive signals from one or more sensors of the fluid management system 10. In some embodiments, the controller 30 can communicate with a database for best practice suggestions and for maintaining patient records that can be displayed to the user on the display screen 44.

[0048] The fluid management system 10 can be user-selectable between different modes based on the procedure, patient characteristics, etc. For example, different modes may include, but are not limited to, fURS mode, BPH mode, hysteroscopy mode, cystoscopy mode, etc. When a mode is selected by the user, mode parameters such as fluid flow rate, fluid pressure, fluid shortage, and temperature can be presented to the user through the display screen. Exemplary parameters for a particular mode can be predetermined using software, for example, and entered into the controller 30. Thus, when the user selects a procedure from the initial display on the touchscreen interface display screen 44, these known parameters can be loaded from the controller 30 into the various components of the fluid management system 10. The fluid management system 10 can also be user-selectable between automatic and manual modes. For example, for a particular procedure, the user may prefer to manually adjust the fluid flow rate, fluid pressure, and / or other parameters. When the user selects manual mode, for example on the touchscreen interface 42, the user can adjust the fluid flow rate or fluid pressure through an optional foot pedal 46, voice commands, or other manual interfaces such as a fluid control interface. When the user selects automatic mode, the controller 30 can determine whether it can use the data obtained from the medical devices 20 to facilitate control of the fluid management system 10. The user may be prompted to select or input which medical device 20 was used, either through the touchscreen interface 42 or by selecting it through the touchscreen interface 42. In some embodiments, the fluid management system 10 may be configured to verify that the selected medical device 20 was actually used before using the collected data.

[0049] The controller 30 may be configured to include visual software / image recognition software that can detect visual noise based on variations in brightness (e.g., light monitor), contrast, or color pictuation. If the image presented to the controller 30 is determined to be unacceptable, the fluid management system 10 may increase the fluid flow rate or fluid pressure to flush the debris from the processing area. The fluid flow rate or fluid pressure may be increased over a temporary period of time (e.g., a predetermined time) or until the field of view is deemed sufficiently clear. This temporary increase ensures that the time for which the fluid flow rate or fluid pressure is increased is limited to ensure that the pressure inside the cavity does not exceed safety limits. Alternatively, the controller 30 may provide an audible warning to the physician or nurse on the display screen 44 that a decrease in field of view has been detected, and the user can then manually adjust the flushing flow rate. In some cases, the physician may generate a baseline level of visibility to which they prefer to initiate a fluid field-clearing flow and input these parameters to the fluid management system 10 via the touchscreen interface 42 before the procedure. With a baseline generated, the fluid management system 10 can monitor the visual feed for any image fluctuations and automatically adjust the fluid flow rate as needed.

[0050] To regulate fluid flow rate or fluid pressure through the fluid management system 10, the fluid management unit may include one or more pressurizing devices such as an inlet pump 50. In some embodiments, the inlet pump 50 may be a peristaltic pump. In some embodiments, the inlet pump 50 may include multiple pumps or more than one pump. The inlet pump 50 may be electrically driven and may receive power from a power source such as a wall outlet, or from an external or internal power storage device such as a disposable or rechargeable battery, and / or an internal power supply. The inlet pump 50 may be operated at a target pressure, for example, 5 mmHg to 50 mmHg, and / or at any desired speed sufficient to deliver fluid at a target fluid flow rate or target fluid pressure. As described herein, the inlet pump 50 may be automatically adjusted based, for example, on pressure and / or temperature measurements within the treatment site and / or visual feedback from a medical device 20. The inlet pump 50 may also be manually adjusted, for example, through an optional foot pedal 46, a touchscreen interface 42, voice commands, or a separate fluid controller. Although not explicitly shown, the fluid controller may be a separate user interface including buttons that allow the user to increase or decrease the flow rate of the inlet pump 50. Alternatively, the fluid controller may be integrated into the main processing device and receive input through a touchscreen interface 42, voice commands, or other input means. It will be understood that any number of pumps can be used. In some embodiments, the fluid management system 10 may include multiple pumps having different flow capabilities. In some embodiments, flow meters may be positioned before and / or after the inlet pump 50.

[0051] The fluid flow rate or fluid pressure at any given time can be displayed on the display screen 44 to allow for surgical chamber (OR) visibility regarding any changes. If an OR staff member notices a change in fluid flow rate or fluid pressure that is too high or too low, the user can manually adjust the fluid flow rate or fluid pressure back to a preferred level. This may occur, for example, when a physician inserts and removes a tool from the working channel of a medical device 20. The fluid management system 10 can also monitor and automatically adjust the fluid flow rate or fluid pressure based on previously set parameters, as described herein. This function can also be useful when fluid flow is manually provided, such as for auxiliary injection lavage through a syringe.

[0052] In some embodiments, the fluid management system 10 may include visual software or image recognition and analysis software. For example, the fluid management system 10 may detect whether a tool has been inserted and which tool was used, for example, through a camera positioned on a medical device 20 inside the body. The tool may have an identifiable marker that can be seen by the visual software to notify the fluid management system 10 of the type of tool used. The fluid management system 10 may then automatically adjust the fluid flow rate or fluid pressure based on the tool identified by the visual software. When the tool retracts from the operating channel, the fluid management system 10 may automatically reduce the fluid flow rate or fluid pressure accordingly.

[0053] In addition to or instead of the above, the fluid management system 10 can automatically adjust the fluid flow rate or fluid pressure based on the intracavitary temperature and / or pressure detected within the treatment site. The intracavitary temperature and / or pressure can be measured in situ using temperature sensors and / or pressure sensors attached to a medical device 20 used in conjunction with the fluid management system 10. In some embodiments, the fluid management system 10 may include flow monitoring software that can be configured by the user so that the inlet pump 50 is automatically started, stopped, and / or speed-controlled by the fluid management system 10 to maintain the fluid flow rate delivered to the treatment site at a target flow rate and / or a predetermined flow rate range. In some embodiments, the fluid management system 10 may include pressure monitoring software that can be configured by the user so that the inlet pump 50 is automatically started, stopped, and / or speed-controlled by the fluid management system 10 so that the fluid pressure delivered to the treatment site at a target pressure and / or a predetermined pressure range. For example, a pressure sensor can detect pressure within a treatment site (e.g., a kidney or uterus) and automatically change the fluid flow rate or fluid pressure in the fluid management system 10 based on the monitored cavity pressure (e.g., within a kidney or uterus). If the cavity pressure is too high, the fluid management system 10 can reduce the fluid flow rate or fluid pressure, and if the cavity pressure is too low, the fluid management system 10 can increase the fluid flow rate or fluid pressure. In an exemplary temperature control mode, the fluid management system 10 may include temperature monitoring software to control (e.g., start, stop, and temperature adjustment) the fluid heating system 60 to maintain the fluid temperature delivered to the treatment site at approximately a target temperature and / or within a predetermined temperature range. For example, the temperature can be monitored in vivo or in vitro, and the fluid flow can be modified based on the supplied temperature feedback. In an exemplary embodiment, the fluid management system 10 can compare the temperature and / or pressure sensed within the treatment site to known values ​​to provide a warning if the parameter is outside a predetermined safety range.Warnings can be visual or audible.

[0054] In some embodiments, the medical device 20 may be a ureteroscope, such as a LithoVue® scope. However, other medical devices, such as another endoscope, may be used in addition to or instead of the ureteroscope. The medical device 20 may be configured to deliver fluid from the fluid management system 10 to the treatment site through an elongated shaft 76 configured to access the treatment site within the patient. In some embodiments, an inflow pump 50 may be in fluid communication with the elongated shaft 76. The elongated shaft 76 may include one or more working lumens that receive the flow of fluid or other medical devices through the elongated shaft 76. The medical device 20 is connected to the fluid management system 10 through one or more supply lines 78 (e.g., tubes).

[0055] In some embodiments, the medical device 20 can electronically communicate with the workstation 81 via a wired connection 79. The workstation 81 may include, among other features, a touch panel computer 83, an interface box 85 that accepts the wired connection 79, a cart 87, and a power supply 89. In some embodiments, the interface box 85 may be configured to have a wired or wireless connection 91 to the controller 30 of the fluid management system 10. The touch panel computer 83 may include at least a display screen and an image processing device. In some embodiments, the workstation 81 may be a multi-use component (e.g., used in multiple procedures), while the medical device 20 may be a single-use device, although this is not required. In some embodiments, the workstation 81 may transmit pressure data (e.g., obtained by the medical device 20) to the controller 30 of the fluid management system 10. The controller 30 of the fluid management system 10 can then use the pressure data from the medical device 20 to adjust the fluid flow rate or fluid pressure when a user-specified or predetermined pressure limit is reached. In some embodiments, the workstation 81 can be omitted, and the medical device 20 can be directly and electronically coupled to the controller 30 of the fluid management system 10.

[0056] One or more supply lines 8 from the fluid management system 10 to the medical device 20 may be made of a material that helps to dampen the peristaltic motion generated by the inflow pump 50. In some embodiments, the medical device 20 may include one or more sensors located near the distal end of the elongated shaft 76. For example, the medical device 20 may include a pressure sensor at the distal end of the elongated shaft 76 to measure the pressure within a cavity in the treatment site. The medical device 20 may also include other sensors, such as a temperature sensor, a fiber Bragg grating optical fiber for detecting stress, and / or an antenna or electromagnetic sensor (e.g., a position sensor). In some embodiments, the distal end of the medical device 20 may also include at least one camera that provides a visual feed to the user on the display screen of the touch panel computer 83. In some embodiments, the medical device 20 may include two cameras having different communication requirements or protocols so that different information can be relayed to the user by each camera. When configured in this way, the user can switch back and forth between the cameras via the touchscreen interface 42 and / or the touch panel computer 83. In some embodiments, one or more sensors can be used to verify that the medical device 20 has actually been used and / or placed in a patient. Although not expressly shown, the medical device 20 and / or the elongated shaft 76 may include one or more working lumens that accept fluids and / or other medical devices.

[0057] The medical device 20 includes a handle coupled to the proximal end of an elongated shaft 76. The handle may have a fluid flow on / off switch, thereby allowing the user to control when the fluid flows through the medical device 20 to the treatment site. The handle may further include other buttons that perform various other functions. For example, in some embodiments, the handle may include a button to control the fluid temperature. In some embodiments, the medical device 20 may include a laser so that the user can emit laser energy. A laser fiber may be connected to a laser system and inserted through the working lumen of the medical device 20. The user may emit the laser so that energy comes out of the tip of the laser fiber and strikes the debris / stone to break up the debris / stone and / or excise the target tissue. In some embodiments including a laser, a communication line (e.g., wired connection or wireless) is maintained between the laser system and the handle of the medical device 20. While exemplary embodiments describe a ureteroscope, it will be understood that the features detailed above can also be directly incorporated into cystoscopes, endoscopes, hysteroscopes, or virtually any device having imaging capabilities. In some embodiments, the medical device 20 may also include a drainage port 88 that can be connected to a drainage system. Some exemplary drainage systems are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled “Automated Fluid Management Systems,” by the same applicant as this application, the disclosure of which is incorporated herein by reference.

[0058] In some embodiments, the controller 30 can be configured to calculate fluid deficit when the distal end of the elongated shaft 76 is placed in the patient, where fluid deficit represents fluid lost during the procedure, absorbed by the patient, and / or otherwise not addressed.

[0059] Before starting the procedure, the fluid management system 10 may need to be primed to remove any air from the system. Priming the fluid management system 10 may result in some fluid loss. In some embodiments, the controller 30 can be configured to automatically reset the fluid shortage to zero after priming the fluid management system 10. In some embodiments, the controller 30 can be configured to automatically start the fluid shortage calculation when signals from one or more sensors indicate that the distal end of the elongated shaft 76 has been inserted into the patient. In some embodiments, the controller 30 can be configured to automatically pause the fluid shortage calculation when the distal end of the elongated shaft 76 has been removed from the patient. In some embodiments, the controller 30 can be configured to automatically resume the fluid shortage calculation when signals from one or more sensors indicate that the distal end of the elongated shaft 76 has been reinserted into the patient. In some embodiments, the controller 30 can be configured to calculate the fluid shortage only when the distal end of the elongated shaft 76 is in place in the patient.

[0060] In some embodiments, the fluid shortage calculation can be started after the initial system setup (e.g., before priming). In some embodiments, the fluid used during system priming can be excluded from the fluid shortage calculation and / or subtracted from the calculated fluid shortage to determine the actual fluid shortage. For example, the supply line 78 (single / double) and / or heater cassette 64 define and / or have known fluid capacities. In some embodiments, the controller 30 can be configured to exclude the known fluid capacities of the supply line 78 (single / double) and / or heater cassette 64 from the fluid shortage calculation.

[0061] In some embodiments, the controller 30 may be configured to notify the user when the total fluid shortage reaches a preset fluid shortage limit. In some embodiments, the controller 30 may be configured to stop the inflow pump 50 and / or the vacuum pump 24 when the total fluid shortage reaches a preset fluid shortage limit.

[0062] In some embodiments, the controller 30 may be configured to notify the user when the total amount of injected fluid reaches a preset fluid injection limit. In some embodiments, the controller 30 may be configured to stop the inflow pump 50 and / or the vacuum pump 24 when the total amount of injected fluid reaches a preset fluid injection limit.

[0063] In some embodiments, the controller 30 may be configured to monitor the amount of fluid in the first fluid source 34 by weight, for example, using a supply load cell 94, a scale, or other suitable means. The reading from the supply load cell 94 may be shown to the user on a display screen 44. As the procedure progresses, the reading from the supply load cell 94 may be updated in real time to alert the physician how much fluid remains in the first fluid source 34, and this amount can then be used to determine how much fluid has been injected into the patient. In some embodiments, the remaining amount of fluid and / or the time the fluid will remain in the first fluid source 34 (e.g., at the current utilization rate) may be shown. The warning may be shown on the display screen 44 along with an audible signal when, for example, 10% of the fluid remains in the first fluid source 34. In some embodiments, the supply load cell 94 may be connected to the display screen 44 via a wireless (e.g., Wi-Fi) signal. In some embodiments, the supply load cell 94 may be connected to the display screen 44 via a wired connection.

[0064] Similarly, the controller 30 can be configured to monitor the amount of fluid in the recovery container 26 by weight, for example, using a recovery load cell 25, a scale, or other suitable means. The reading from the recovery load cell 25 can be shown to the user on the display screen 44. As the procedure progresses, the reading from the recovery load cell 25 can be updated in real time to alert the physician how much fluid is in the recovery container 26, and this amount can then be used to determine how much fluid has been recovered from the patient and / or the recovery drape 28. In some embodiments, the amount of fluid in the recovery container 26 and / or the amount of time remaining before the recovery container 26 is full can be shown. The warning can be shown on the display screen 44 along with an audible signal, for example, when 10% of the initial empty volume remains in the recovery container 26. In some embodiments, the recovery load cell 25 can be connected to the display screen 44 via a wireless (e.g., Wi-Fi) signal. In some embodiments, the recovery load cell 25 can be connected to the display screen 44 via a wired connection.

[0065] In some embodiments, the fluid management system 10 may include a pressure sensor connected inline between a first fluid supply source 34 and a medical device 20, and the pressure in the supply line 78 is determined based on the height of the first fluid supply source 34. The amount of head pressure decreases when the first fluid supply source 34 becomes empty. When the pressure falls below a threshold set by the user, a warning can be displayed on a display screen 44 and an audible signal can be emitted. In some embodiments, a flow sensor may be connected inline between the first fluid supply source 34 and the medical device 20. The flow sensor may be operatively connected to a controller 30, and data from the flow sensor can be used by the controller 30 to modify selected system parameters and / or for fluid shortage calculations.

[0066] The fluid management system 10 can utilize supply lines 78 to connect various components. In some embodiments, the supply lines 78 can be formed from small-diameter tubing shorter than or equal to 1 / 16 inch (1.5875 millimeters) in diameter. However, it will be understood that the size of the tubing may vary depending on the application. The supply lines 78 and / or tubing can be disposable, sterile, and supplied in a ready-to-use state. Different types of tubing can be used for various functions within the fluid management system 10. For example, one type of tubing can be used for fluid heating and fluid flow control to a medical device 20, while another type of tubing can be used for cleaning within the body and / or treatment site.

[0067] In some embodiments, the fluid management system 10 may include a fluid heating system 60 for heating the fluid delivered to the patient, as shown in more detail in Figure 2. The fluid heating system 60 may include a heater 62 and a heater cassette 64. The heater cassette 64 may be configured to be a single-use heater cassette 64, while the heater 62 can be reused for multiple procedures. For example, the heater cassette 64 may be able to isolate the fluid flow within it so that the heater 62 can be reused with minimal maintenance. The heater cassette 64 may be formed from, for example, polycarbonate or any high-temperature rated biocompatible plastic, and may be formed as a single unit and a monolithic part or as multiple parts permanently bonded to each other. In some embodiments, the heater cassette 64 may include a fluid inlet port 61 and a fluid outlet port 63 located on the side of the heater cassette 64. Each of the fluid inlet port 61 and the fluid outlet port 63 may be configured to be connected to a supply line 78 of the fluid management system 10. For example, the fluid inlet port 61 can be connected to the first fluid supply source 34, the inlet pump 50, and the fluid heating system 60, while the fluid outlet port 63 can be connected to the fluid heating system 60 and the medical device 20, each through a supply line 78. The inlet pump 50 is shown as a peristaltic pump in Figure 2, but other configurations and / or types of pumps are also conceivable.

[0068] In some embodiments, the heater cassette 64 may include an internal flow path along a channel through which fluid can flow from a fluid inlet port 61 to a fluid outlet port 63. The heater cassette 64 may include one or more flow paths. In some embodiments, the channel may pass through a susceptor 66 which can allow the fluid to be heated through induction heating. When the heater cassette 64 is coupled with the heater 62, the susceptor 66 may be positioned within an induction coil 68 configured to heat the fluid flowing through the susceptor 66. Other fluid heating system configurations and methods may also be used as needed. For example, the heater 62 may include one or more heat sources, such as a platen system or an inline coil in a supply line 78 using electrical energy. The heating can be specially designed and adjusted to the flow rate required for a particular application of the fluid management system 10. Some exemplary fluid heating systems 60 are described in U.S. Patent Application Publication No. 2018 / 0361055, published by the same applicant as this application, entitled “Automated Fluid Management Systems,” the entire disclosure of which is incorporated herein by reference.

[0069] Although not explicitly shown, the fluid heating system 60 may include a heater user interface separate from the touchscreen interface 42. In one example, the heater user interface may simply be a display screen that presents a digital display of the internal temperature of the heater 62. In another embodiment, the user interface may also include temperature control buttons to increase or decrease the temperature of the heater 62. In this embodiment, the heater user interface and / or display screen may show the current temperature of the heater 62, as well as the target temperature to be reached. Note that all information output from the fluid heating system 60 can be transmitted directly to the display screen 44, eliminating the need for a heater user interface.

[0070] The fluid heating system 60 may include one or more sensors configured to monitor the fluid flowing through the fluid heating system 60. For example, a temperature sensor 65 may be mounted on the fluid heating system 60 to detect the temperature of the fluid flowing through the heater cassette 64. In some embodiments, the temperature sensor 65 may be located at or near the fluid inlet port 61 and / or fluid outlet port 63. In some embodiments, the temperature sensor 65 may be mounted to detect the temperature of the fluid flowing through the heater cassette 64 before the fluid enters the susceptor 66 and after the fluid exits the susceptor 66. In some embodiments, an additional sensor may be located in the center of the susceptor 66 to detect the progression of the temperature rise of the fluid within the heater cassette 64. The temperature sensor 65 may remotely transmit any information to the display screen 44, or to the heater user interface and / or the interface's display screen, if provided. In another embodiment, the temperature sensor 65 may be wired to the heater user interface (if provided), which can then remotely transmit desired information to the display screen 44. Alternatively, or in addition to the above, the temperature sensor 65 may be wired to and / or connected to the controller 30.

[0071] The heater 62 may further include a pressure sensor 67 and / or a bubble sensor 69. The heater cassette 64 may include corresponding pressure sensor interfaces 71 and 73, respectively, which allow the pressure sensor 67 and the bubble sensor 69 to monitor the fluid flowing through the heater cassette 64 when the heater cassette 64 is coupled to the fluid heating system 60. The pressure sensor 67 and / or the bubble sensor 69 can remotely transmit any information to the display screen 44, or they can transmit information to the heater user interface and / or the display screen of the heater user interface, if provided therefor. In another embodiment, the pressure sensor 67 and / or the bubble sensor 69 can be wired to the heater user interface (if provided), which can then remotely transmit desired information to the display screen 44. Alternatively or in addition thereto, the pressure sensor 67 and / or the bubble sensor 69 can be wired to and / or connected to the controller 30.

[0072] In some embodiments, the medical system may comprise a medical device 20 as described herein, a fluid management system 10 as described herein, and a laser device 100. Figure 3 shows an exemplary laser device 100 that can be used with the medical system. In some embodiments, the laser device 100 may include a laser controller 110. In some embodiments, the laser controller 110 may communicate electronically with a controller 30 of the fluid management system 10 (e.g., via wired or wireless connection). In some embodiments, the laser device 100 may include an elongated tubular member 116 configured for insertion through the working lumen of the medical device 20 and / or the elongated shaft 76 of the medical device 20. The laser device 100 may include a proximal elongated member and / or a laser fiber 114 extending from a proximal connector 112 to a handle portion 130. In some embodiments, the laser fiber 114 may extend and / or be positioned inside the proximal elongated member to protect the laser fiber 114. The proximal connector 112 can connect the proximal elongated member and / or the laser fiber 114 to the laser controller 110.

[0073] The handle portion 130 may be located at the proximal end of the elongated tubular member 116, and / or the elongated tubular member 116 may extend distally from the handle portion 130. The laser fiber 114 may extend longitudinally through the handle portion 130 and the elongated tubular member 116 to a position close to the distal end of the elongated tubular member 116. The laser device 100 and / or the handle portion 130 of the laser device 100 may include a cooling tube 120 that extends proximal from the proximal portion and / or end of the handle portion 130 to a cooling tube connector 122. The cooling tube 120 may define a cooling tube lumen 124 that extends from the cooling tube connector 122 into the handle portion 130. In some embodiments, the cooling tube 120 may extend into the handle portion 130. In some embodiments, the handle portion 130 can define individual segments of the cooling tube lumen 124 within the handle portion 130, and the individual segments are in fluid communication with the cooling tube lumen 124.

[0074] In some embodiments, the handle portion 130 may include a knob portion 132 adjacent to the distal end of the handle portion 130. In at least some embodiments, the knob portion 132 of the handle portion 130 and / or the handle portion 130 may be configured to rotate an elongated tubular member 116. In some embodiments, the elongated tubular member 116 may be non-rotatably and / or fixedly attached to the knob portion 132 of the handle portion 130. In some embodiments, the knob portion 132 may be rotatable with respect to the handle portion 130 and / or a laser fiber 114 positioned in and / or extending through the handle portion 130. In some embodiments, the knob portion 132 may include a thumb paddle extending radially outward to assist in the rotation of the knob portion 132.

[0075] As shown in the partial cross-section in Figure 4, the laser fiber 114 may extend through the handle portion 130 and / or the knob portion 132 of the handle portion 130. The cooling tube lumen 124 may extend from the proximal portion and / or proximal end of the handle portion 130 to a cooling reservoir 126 located within the handle portion 130 and / or the knob portion 132 of the handle portion 130. In embodiments where the handle portion 130 defines separate segments of the cooling tube lumen 124, the separate segments are in fluid communication with both the cooling tube lumen 124 and the cooling reservoir 126 of the cooling tube 120. The cooling reservoir 126 may substantially surround the laser fiber 114, and / or the laser fiber 114 may extend through the cooling reservoir 126. As can also be seen in Figure 4, the elongated tubular member 116 may include a cooling channel 128 and a laser fiber 114 extending distally within the cooling channel 128. The cooling channel 128 can be in fluid communication with the cooling reservoir 126 and / or the cooling tube lumen 124. In some embodiments, the cooling channel 128 can substantially surround the laser fiber 114. In some embodiments, the laser fiber 114 can be coaxially positioned within the cooling channel 128. In some embodiments, the laser fiber 114 can be offset from the central longitudinal axis of the cooling channel 128.

[0076] As can be seen in Figure 5, the elongated tubular member 116 may include a closed distal end. Figure 5 is a side view of the elongated tubular member 116, with a partial cross-section at the top of the page and a bottom view of the elongated tubular member 116 at the bottom of the page. The laser device 100 and / or the elongated tubular member 116 may include a mirror 118 positioned in the distal portion of the elongated tubular member 116. The laser fiber 114 may be terminated at and / or adjacent to the mirror 118. The mirror 118 may be a reflecting element configured to redirect the laser energy from the laser fiber 114 out of the distal port 140 of the elongated tubular member 116 so that the laser energy exits the elongated tubular member 116 through the distal port 140, as shown in Figure 5. In some embodiments, a cooling channel 128 may be terminated at the distal port 140. In some embodiments, the fluid flowing through and / or within the cooling channel 128 can exit the elongated tubular member 116 through the distal port 140. In some embodiments, the distal port 140 may be located near the distal end and / or distal tip of the elongated tubular member 116.

[0077] The distal end of the laser fiber 114 may become hot when the laser device 100 is in use. Excessive heat can damage the distal end of the laser fiber 114. The cooling channel 128 is used to extend the lifespan and improve the function of the laser fiber 114 and / or the laser device 100 by providing liquid cooling of the laser fiber 114. However, insufficient fluid flow and / or pressure over the laser fiber 114 can lead to the accumulation of excess heat at the distal end of the laser fiber 114. Laser fibers, such as those in the laser device 100 that have used liquid cooling, are typically cooled using a gravity-fed system, where fluid pressure and flow can change and / or decrease over time as the fluid source is discharged. An alternative fluid management system configuration is considered desirable for better cooling of the laser fiber 114.

[0078] Returning to Figure 1, the fluid management system 10 may further include a second fluid source 35 and a second fluid source hanger 33 attached to the fluid management unit, the second fluid source hanger 33 supporting the second fluid source 35. In some embodiments, the position and / or weight of the second fluid source 35 can be detected using a remote sensor and / or cooling supply load cell associated with and / or operatively coupled to the second fluid source hanger 33. The controller 30 can electronically communicate with the cooling supply load cell. The second fluid source hanger 33 can be configured to accept second fluid sources 35 of various sizes, such as fluid bags from 1 liter (L) to 5 L. It will be understood that any number of second fluid sources 35 can be used. Furthermore, second fluid sources 35 of any size can be used depending on the procedure. The second fluid source hanger 33 may extend from the pole 36 and / or controller 30 and may include one or more hooks from which the second fluid source 35 can be suspended. In some embodiments, the second fluid source 35 may be 0.9% saline solution. However, it will be understood that various other fluids with different viscosities may be used depending on the procedure.

[0079] The fluid management system 10 may include a cooling pump 53 configured to pump fluid from a second fluid supply source 35 under pressurized conditions. In some embodiments, the cooling pump 53 may be a peristaltic pump, a diaphragm pump, a positive displacement pump, or other suitable pump type. In some embodiments, the cooling pump 53 may include a disposable single-use pump head configured and / or designed to be replaced after each procedure. For example, the cooling pump 53 may be a standalone pump located outside the fluid management unit. In some embodiments, the cooling pump 53 may be externally mounted and / or face the outside of the fluid management unit. In some practical embodiments, the cooling pump 53 may be reusable. For example, the cooling pump 53 may be located inside the fluid management unit. In at least some embodiments, the controller 30 of the fluid management unit and / or the fluid management system 10 may be configured to control the inflow pump 50 and the cooling pump 53.

[0080] The fluid management system 10 may include one or more cooling supply lines 77. For example, a cooling supply line 77 may connect a second fluid supply source 35 to a cooling pump 53. Furthermore, the cooling supply line 77 may extend from the cooling pump 53 to a distal connector 75, such as a Luer connector, at the distal end of the cooling supply line 77. In some embodiments, depending on the type of pump of the cooling pump 53, the cooling supply line 77 may extend from the second fluid supply source 35 through the cooling pump 53 to the distal connector 75. In at least some embodiments, the distal connector 75 may be configured to connect to a cooling tube connector 122 of the laser device 100, thereby establishing a fluid passage from the second fluid supply source 135 to the distal port 140.

[0081] In some embodiments, the cooling pump 53 may be configured to pump fluid under pressure from a second fluid source 35 through a cooling supply line 77, a cooling tube 120, a cooling tube lumen 124, a cooling reservoir 126, and / or a cooling channel 128. In some embodiments, the controller 30 of the fluid management system 10 may be configured to control the cooling pump 53 based on a set of system operating parameters to maintain a target fluid flow rate through the cooling supply line 77, the cooling tube 120, the cooling tube lumen 124, the cooling reservoir 126, and / or a cooling channel 128. In some embodiments, the controller 30 of the fluid management system 10 may be configured to control the cooling pump 53 based on a set of system operating parameters to maintain a target fluid pressure through the cooling supply line 77, the cooling tube 120, the cooling tube lumen 124, the cooling reservoir 126, and / or a cooling channel 128.

[0082] In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid flow rate between 0 ml (mL) / min and 100 mL / min. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid flow rate between 0 ml (mL) / min and 75 mL / min. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid flow rate between 0 ml (mL) / min and 50 mL / min. In some embodiments, the cooling pump 53 may be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid flow rate of 0 ml (mL) / min to 25 mL / min. Other configurations are also conceivable.

[0083] In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 500 mmHg. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 300 mmHg. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 200 mmHg. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 100 mmHg of mercury. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 50 mmHg of mercury. In some embodiments, the cooling pump 53 can be configured to pump fluid from a second fluid source 35 through a cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128 at a fluid pressure from 0 mmHg to 25 mmHg of mercury. Other configurations are also being considered.

[0084] In some embodiments, the fluid management system 10 may optionally include a pressure sensor 74 positioned between the second fluid supply source 35 and the cooling pump 53. Such an arrangement can, among other applications, enable the detection of fluid loss flowing into the cooling pump 53. In some embodiments, the fluid management system 10 may optionally include a pressure sensor 74 positioned between the cooling pump 53 and the distal end of the cooling channel 128. Such an arrangement can, among other applications, enable the detection of pressure and / or presence and / or flow of fluid through the cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128, and / or prevent overpressure of the cooling supply line 77, cooling tube 120, cooling tube lumen 124, cooling reservoir 126, and / or cooling channel 128. In some embodiments, the fluid management system 10 may optionally include a pressure sensor 74 located between the second fluid supply source 35 and the cooling pump 53, and another pressure sensor 74 located between the cooling pump 53 and the distal end of the cooling channel 128. In some embodiments, the fluid management system 10 may optionally include a flow sensor instead of or in addition to each of the pressure sensors 74. In some embodiments, the fluid management system 10 may optionally include a load sensor instead of or in addition to each of the pressure sensors 74 and / or flow sensors.

[0085] In some embodiments, the handle of the medical device 20 may include a port 86 configured to receive an elongated tubular member 116 of the laser device 100. In some embodiments, the laser device 100 may be connected to and / or fixed to the port 86. In some embodiments, the port 86 may be in fluid communication with the working lumen and / or elongated shaft 76 of the medical device 20.

[0086] In some embodiments, the laser controller 110 (e.g., Figure 3) can communicate electronically with the controller 30 of the fluid management system 10. In some embodiments, the laser controller 110 can be configured to cooperate, adjust, and / or collaborate with the controller 30 of the fluid management system 10 to manage the operation and / or function of the medical system in use. In some embodiments, the laser controller 110 can delay the onset of laser power until after the controller 30 of the fluid management system 10 has started the cooling pump 53. In some embodiments, when the laser controller 110 increases the laser power, the controller 30 of the fluid management system can speed up the cooling pump 53, increase the amount of fluid passing through and / or exiting the cooling pump 53, and / or increase the fluid pressure output by the cooling pump 53. In some embodiments, when the laser controller 110 terminates the laser power, the controller 30 of the fluid management system 10 can stop the cooling pump 53. Other configurations are also possible.

[0087] In some embodiments, the laser controller 110 can monitor the temperature of the distal end of the laser fiber 114 and / or the elongated tubular member 116 and command the controller 30 of the fluid management system 10 to increase the speed of the cooling pump 53 and / or the fluid flow rate and / or fluid pressure output by the cooling pump 53 if the temperature exceeds a predetermined limit. In some embodiments, the controller 30 of the fluid management system can monitor the temperature of the distal end of the elongated tubular member 116 and / or the elongated shaft 76 and increase the speed of the cooling pump 53 and / or the fluid flow rate and / or fluid pressure output by the cooling pump 53 if the temperature exceeds a predetermined limit.

[0088] Those skilled in the art will recognize that the present invention can be expressed in various forms other than the specific embodiments described herein and that can be imagined. Accordingly, deviations in form and detail can be made without departing from the scope and spirit of the invention as described in the claims.

[0089] The materials that can be used in the systems and various components of the systems disclosed herein may include those commonly related to medical devices. For simplicity, the following description refers to systems. However, this is not intended to limit the apparatus and methods described herein, as the described content can be applied to other elements, members, components, or apparatus disclosed herein, including but not limited to fluid management systems, medical devices, laser devices, elongated shafts, elongated tubular members, laser fibers, inflow pumps, outflow pumps, cooling pumps, fluid heating systems, controllers, laser controllers, supply lines, load cells, handles, workstations, display screens, fluid supply sources, recovery containers, and / or their elements or components.

[0090] In some embodiments, the system and / or components of the system may be made from metals, metal alloys, polymers (some examples thereof are disclosed below), metal-polymer composites, ceramics, and combinations thereof, or other suitable materials.

[0091] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®, available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate, and / or other ester elastomers such as HYTREL® from DuPont, polyamides (e.g., DURETHAN®, available from Bayer, Elf Available from Atochem: CRISTAMID®, elastomer polyamide, block polyamide / ether, polyester block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate Poly(PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (GRILAMID®, available from EMS American Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS)The materials may include polycarbonate, polyurethane silicone copolymers (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the sheath may be formulated with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0092] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, and other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22, HASTELLOY® C276 (registered trademark) Nickel-copper alloys (e.g., UNS:N10276, and other HASTELLOY® alloys), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY This includes cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (such as UNS:N10665, including B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (such as UNS:R30003, including ELGILOY® and PHYNOX®), platinum-enriched stainless steel, titanium, platinum, palladium, gold, combinations thereof, or other suitable materials.

[0093] In at least some embodiments, some or all of the system and / or its components may be doped with, manufactured from, or otherwise incorporate radiopaque material. Radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopic screen or other imaging technique during a medical procedure. This relatively bright image helps the system user determine its location. Some examples of radiopaque material may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials filled with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may also be incorporated into the system design to obtain the same result.

[0094] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the systems and / or their components or parts can be manufactured from materials that do not substantially distort images and do not produce substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials are considered unsuitable, for example, because they may produce artifacts in MRI images. The systems or their parts can also be manufactured from materials that can be imaged by an MRI machine. Materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (such as UNS:R30003, e.g., ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (such as UNS:R30035, e.g., MP35-N®), and nitinol, and others.

[0095] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with appropriate therapeutic agents. Some examples of preferred therapeutic agents include antithrombotic agents (heparin, heparin inducers, urokinase, and PPack (dextrophenylalanine, proline, arginine)). Antiproliferative agents (such as chloromethyl ketone), antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies that can block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), anti-cancer agents / antiproliferative agents / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epotilon, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine), anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone) This may include lucetone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, antiplatelet peptides, etc., vasoproliferators (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, translation promoters, etc.), vasoproliferators (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins, etc.), cholesterol lowering agents, vasodilators, and agents that interfere with endovascular activity mechanisms.

[0096] It should be understood that the disclosure of this invention is, in many respects, merely illustrative. Modifications can be made in detail, particularly with respect to shape, size, and arrangement of steps, without exceeding the scope of the invention. This may include, to the extent appropriate, the use of any of the features of the exemplary embodiments used in other embodiments. The scope of this invention is, of course, defined in the language in which the appended claims are expressed. [Explanation of Symbols]

[0097] 10 Fluid Management Systems 20 Medical Devices 30 controllers 34. First fluid supply source 50 Inflow pump

Claims

1. It is a medical system, An endoscope comprising: an elongated shaft configured to access a treatment site within a patient; a working lumen extending through the elongated shaft; and a handle coupled to the proximal end of the elongated shaft and including a port that is in fluid communication with the working lumen; A laser device comprising an elongated tubular member configured for insertion through the working lumen of the endoscope, the elongated tubular member including a cooling channel and a laser fiber extending distally within the cooling channel, A fluid management system comprising: an inflow pump configured to provide fluid flow through the elongated shaft of the endoscope to the treatment site; a cooling pump configured to provide fluid flow through the cooling channel of the elongated tubular member of the laser device to cool the laser fiber, so that it exits from the distal tip of the laser device; and a controller configured to control the inflow pump and the cooling pump; A medical system characterized by being equipped with the following features.

2. The medical system according to claim 1, characterized in that the laser device includes a laser controller that electronically communicates with the controller of the fluid management system.

3. The medical system according to claim 2, characterized in that when the laser controller increases the laser power, the controller of the fluid management system increases the speed of the cooling pump.

4. The medical system according to claim 2 or 3, characterized in that when the laser controller terminates the laser power, the controller of the fluid management system stops the cooling pump.

5. The medical system according to claim 2 or 3, characterized in that the laser controller delays the activation of the laser power until after the controller of the fluid management system has activated the cooling pump.

6. The medical system according to claim 2 or 3, characterized in that the laser controller monitors the temperature of the distal end of the laser fiber and commands the controller of the fluid management system to increase the cooling pump speed when the temperature exceeds a predetermined temperature limit.

7. The medical system according to claim 2 or 3, characterized in that the endoscope communicates electronically with a workstation.

8. The medical system according to claim 7, characterized in that the workstation communicates with the controller of the fluid management system via wired or wireless communication.

9. The medical system according to any one of claims 1 to 3, characterized in that the cooling channel surrounds the laser fiber.

10. The medical system according to claim 9, characterized in that the cooling channel terminates at a distal port adjacent to the distal end of the elongated tubular member.

11. The medical system according to claim 10, characterized in that the laser energy exits the elongated tubular member through the distal port.

12. The medical system according to any one of claims 1 to 3, further comprising a pressure sensor disposed between the cooling pump and the distal end of the cooling channel.

13. The medical system according to any one of claims 1 to 3, characterized in that the endoscope includes a pressure sensor positioned close to the distal end of the elongated shaft and configured to measure intracavitary pressure at the treatment site.

14. The medical system according to any one of claims 1 to 3, characterized in that the endoscope includes a temperature sensor positioned close to the distal end of the elongated shaft and configured to measure the intracavitary temperature at the treatment site.

15. The medical system according to any one of claims 1 to 3, characterized in that the cooling pump is a peristaltic pump, a diaphragm pump, or a positive displacement pump.

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