Fluid management system

Abstract

To provide a fluid management system.SOLUTION: A fluid management system may include an inflow pump providing a fluid inflow to a medical device, at least one pressure sensor, and a controller configured to receive pressure signals from the at least one pressure sensor, the pressure signals corresponding to a system pressure within the fluid management system. The controller may be configured to detect which one of a plurality of medical devices is fluidly connected to the inflow pump on the basis of the pressure signals from the at least one pressure sensor and a rpm of the inflow pump.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 190,570, filed May 19, 2021, the disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to fluid management systems, and more particularly to fluid management systems and controls for fluid management systems. [Background technology]

[0003] Flexible ureteroscope (fURS), gynecological, and other endoscopic procedures require fluid circulation for a variety of reasons. Current practitioners deliver fluids in a variety of ways, such as by using gravity to deliver fluid from a hanging fluid bag, by filling a syringe with fluid and manually injecting it, or by using a peristaltic pump to deliver fluid from a reservoir at a fixed pressure or flow rate via a fluid management system. The fluid management system can adjust the flow rate and / or pressure as the fluid is delivered from the reservoir based on data collected from a procedural device, such as, but not limited to, an endoscope and / or a fluid management system. Known medical devices, systems, and methods each have certain advantages and disadvantages. For example, existing systems can provide only limited control of pressure and / or flow rate when a medical device or tool is inserted into the working channel of an endoscope. In some cases, this limited control can result in pressure gradients greater than normal physiological levels, thereby posing a risk to the patient. There is a continuing need to provide alternative fluid management systems. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application No. 2018 / 0361055 Summary of the Invention [Means for solving the problem]

[0005] In one example, a fluid management system can include an inflow pump that provides fluid inflow to a medical device, at least one pressure sensor, and a controller configured to receive a pressure signal from the at least one pressure sensor corresponding to a system pressure within the fluid management system. The controller can be configured to detect which one of a plurality of medical devices is fluidly connected to the inflow pump based on the pressure signal from the at least one pressure sensor and the revolutions per minute (rpm) of the inflow pump.

[0006] In addition to or in the alternative to any of the examples described herein, the controller is configured to automatically adjust one or more outputs for controlling the inflow pump based on which one of the multiple medical devices is fluidly connected to the inflow pump.

[0007] Additionally or alternatively to any of the examples described herein, the controller includes a PID controller responsive to one or more outputs.

[0008] Additionally or alternatively to any of the examples described herein, the controller calculates a power coefficient based on the inlet pump revolutions per minute and the system pressure.

[0009] Additionally or alternatively to any of the examples described herein, the controller compares the output coefficient to a set of multiple known ranges, each known range corresponding to one of multiple medical devices.

[0010] In addition to or in the alternative to any of the examples described herein, each known range has a different corresponding output that is used to adjust the RPM of the inflow pump.

[0011] In addition to or in the alternative to any of the examples described herein, the output includes a proportional error rate (Kp), an integral error rate (Ki), a differential error rate (Kd), and a sampling rate (SR).

[0012] In addition to or in the alternative to any of the examples described herein, the controller is configured to selectively perform flushing in response to a system pressure setpoint, a system pressure limit, and a medical device damage limit, the flushing being configured to increase the system pressure by a predetermined amount for a predetermined period of time.

[0013] Additionally or alternatively to any of the examples described herein, a predetermined amount of cleaning that exceeds a system pressure limit may be throttled to the system pressure limit.

[0014] Additionally or alternatively to any of the examples described herein, if the controller determines that a predetermined amount of wash will exceed the system pressure limit, a notification is displayed and a wash override input is made available. Activation of the wash override input allows the controller to exceed the system pressure limit by a predetermined amount up to the medical device damage limit.

[0015] Additionally or alternatively to any of the examples described herein, a predetermined amount of irrigation that exceeds the medical device damage limit may be limited to the amount of irrigation that exceeds the medical device damage limit.

[0016] In addition to or in the alternative to any of the examples described herein, the system pressure setpoint, system pressure limit, and medical device damage limit are automatically selected based on which one of a plurality of medical devices is fluidly connected to the inflow pump.

[0017] Additionally or alternatively to any of the examples described herein, at least one pressure sensor is positioned downstream of the inflow pump and upstream of the medical device.

[0018] In addition or in place of any of the examples described herein, the fluid management system can include an inflow pump that provides fluid inflow to a medical device, at least one pressure sensor, and a controller configured to receive a pressure signal from the at least one pressure sensor corresponding to a system pressure within the fluid management system. The controller can be configured to detect which one of a plurality of medical devices is fluidly connected to the inflow pump based on the pressure signal from the at least one pressure sensor and the revolutions per minute of the inflow pump. The controller can be configured to automatically adjust one or more outputs for controlling the inflow pump based on which one of the plurality of medical devices is fluidly connected to the inflow pump. The controller can be configured to selectively perform flushing in response to a system pressure setpoint, a system pressure limit, and a medical device damage limit that are automatically selected based on which one of the plurality of medical devices is fluidly connected to the inflow pump, the flushing being configured to increase the system pressure by a predetermined amount for a predetermined period of time.

[0019] Additionally or alternatively to any of the examples described herein, at least one pressure sensor is positioned downstream of the inflow pump and upstream of the medical device.

[0020] In addition to or in the alternative to any of the examples described herein, the fluid management system may further include a distal pressure sensor disposed at the distal end of one of the plurality of medical devices fluidly connected to the inflow pump.

[0021] Additionally or alternatively to any example described herein, the distal pressure sensor is configured to monitor an increase in in-situ pressure caused by irrigation, and the controller is configured to limit a predetermined amount and / or a predetermined duration of irrigation such that the in-situ pressure remains below a predetermined in-situ pressure limit.

[0022] In addition or in the alternative to any of the examples described herein, the fluid management system can include an inflow pump that provides fluid inflow to the medical device, at least one pressure sensor configured to detect a system pressure within the fluid management system downstream of the inflow pump, and a controller configured to detect which one of the plurality of medical devices is fluidly connected to the inflow pump based on the system pressure within the fluid management system and the revolutions per minute of the inflow pump. The controller can be configured to automatically adjust one or more outputs for controlling the inflow pump based on which one of the plurality of medical devices is fluidly connected to the inflow pump.

[0023] In addition or alternatively to any of the examples described herein, the controller includes pre-loaded data curves relating system pressure to revolutions per minute of the inflow pump for each of the plurality of medical devices.

[0024] In addition to or in the alternative to any of the examples described herein, the controller is configured to automatically enable the flow compensation mode based on which one of the multiple medical devices is fluidly connected to the inflow pump.

[0025] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

[0026] The present disclosure can be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a schematic diagram of selected aspects of a fluid management system; [Figure 2]2 is a schematic diagram of selected aspects of the medical devices and workstations of the system of FIG. 1. [Figure 3] 3A-3C are schematic diagrams of selected embodiments of the medical device of FIG. 2. [Figure 4] 2 is a partial perspective view illustrating selected aspects of the heater assembly and heater cassette of the fluid management system of FIG. 1. [Figure 5] FIG. 1 illustrates a control configuration for a fluid management system. [Figure 6A] FIG. 10 illustrates the behavior within the fluid management system when a tool is inserted into the working channel of a medical device when only system pressure is available to the system. [Figure 6B] FIG. 10 illustrates the behavior within the fluid management system when a tool is inserted into the working channel of a medical device when only system pressure is available to the system. [Figure 7A] FIG. 10 illustrates the characteristics within a fluid management system when a tool is inserted into a working channel of a medical device when system pressure and in situ pressure are available to the system. [Figure 7B] FIG. 10 illustrates the characteristics within a fluid management system when a tool is inserted into a working channel of a medical device when system pressure and in situ pressure are available to the system. [Figure 8A] FIG. 1 illustrates characteristics within a fluid management system during a cleaning event. [Figure 8B] FIG. 1 illustrates characteristics within a fluid management system during a cleaning event. [Figure 8C] FIG. 1 illustrates characteristics within a fluid management system during a cleaning event. [Figure 8D] FIG. 1 illustrates characteristics within a fluid management system during a cleaning event. [Figure 9] 1 is a graph illustrating pressure versus flow characteristics of selected combinations of medical devices and / or medical tools. [Figure 10] FIG. 1 illustrates an example fuzzy logic associated with a fluid management system.

[0028] While the present disclosure is susceptible to various modifications and variations, details thereof are shown by way of example in the drawings and will be described in detail below. It is to be understood, however, that there is no intention to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0029] The following description should be read with reference to the drawings, which are not necessarily to scale and in which like reference numerals indicate like elements throughout the several views. The detailed description and drawings illustrate the present disclosure, but are not intended to be limiting. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings specifically set forth exemplary embodiments of the present disclosure. However, for purposes of clarity and ease of understanding, not every feature and / or element may be shown in every drawing, although it can be understood that these features and / or elements are present in each instance unless otherwise specified.

[0030] For the following defined terms, these definitions shall be applied, unless a different definition is provided in the claims or elsewhere in this specification.

[0031] As used herein, all numerical values ​​are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) can be assumed to have the ordinary and customary definition of the term that is understood in the context of, and not inconsistent with, this specification, unless otherwise specified.

[0032] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0033] Although some suitable dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, those skilled in the art, alerted by the present disclosure, will understand that the desirable dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0034] As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and claims, the term "or" is generally used to include "and / or" unless the context clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular even though they may be multiple or repeated within an embodiment of the present disclosure. Each instance of these features may be included in and / or encompassed by the disclosure in the singular, unless expressly stated to the contrary. For purposes of brevity and clarity, not every element of the present disclosure is shown in each figure or discussed in detail below. However, it will be understood that when more than one element is present, the following discussion may equally apply to any and / or all of these elements, unless expressly stated to the contrary. Furthermore, for purposes of clarity, not every instance of some element or feature may be shown in each figure.

[0035] Relative terms such as “proximal,” “distal,” “advance,” “retract,” and variations thereof may generally be determined with respect to the positioning, orientation, and / or manipulation of various elements relative to a user / operator / manipulator of a device, with “proximal” and “retract” indicating or meaning closer to or toward the user, and “distal” and “advance” indicating or meaning farther from or away from the user. In some instances, the terms “proximal” and “distal” may be assigned arbitrarily in an attempt to facilitate understanding of the present disclosure, but such instances 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 body lumen, a lumen such as a blood vessel, or within a device. Still other relative terms such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” etc., and / or variations thereof, generally refer to directions and / or orientations relative to a central longitudinal axis of a structure or device of the present disclosure.

[0036] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include particular features, structures, or characteristics, but that not all embodiments necessarily include these particular features, structures, or characteristics. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when particular features, structures, or characteristics are described with respect to an embodiment, it will be within the knowledge of one skilled in the art to achieve these particular features, structures, or characteristics with respect to other embodiments, unless expressly stated otherwise. That is, one skilled in the art will understand that the various individual elements described below, even if not specified in specific combinations, are still contemplated as being combinable or configurable with one another to form other or additional embodiments or to complement and / or extend the described embodiments.

[0037] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or claims to name and / or distinguish among various features described and / or claimed. It should be understood that this numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, for purposes of brevity and clarity, variations and departures from previously used numerical nomenclature may be made. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely and / or a different feature may be referred to as the "first" element. The meaning and / or designation in each instance will be apparent to one of ordinary skill in the art.

[0038] Some fluid management systems for use in flexible ureteroscopy (fURS) procedures (e.g., ureteroscopy, percutaneous nephrolithotomy (PCNL), benign prostatic hyperplasia (BPH), transurethral resection of the prostate), gynecological endoscopic procedures, and other endoscopic procedures may attempt to regulate body cavity pressure when used in conjunction with an endoscopic device using pressure and / or flow data therefrom. During an fURS procedure, the body cavity may be dilated to facilitate target location. In some procedures, blood and / or debris may be present within the body cavity, which may adversely affect image quality through the endoscopic device. To improve image quality, the body cavity may be cleansed using fluid flow (e.g., irrigation) through the endoscopic device. In some procedures, the body cavity may be relatively small and irrigation fluid may flow constantly, thereby increasing intraluminal fluid pressure and / or system pressure (e.g., fluid pressure within the fluid management system itself). High intraluminal fluid pressure and / or system pressure may pose a risk to the patient in some circumstances. Therefore, fluid flow (eg, perfusion) into the body cavity must be maintained to maintain good visualization while limiting and / or reducing intraluminal fluid pressure and / or system pressure.

[0039] FIG. 1 is a schematic diagram of a fluid management system 10 that can be used in an endoscopic procedure, such as an fURS procedure. The fluid management system 10 can be coupled to a medical device 20 that allows fluid flow therethrough. In some embodiments, the fluid management system 10 and / or the medical device 20 can include at least one pressure sensor. In some embodiments, the medical device 20 can be an endoscope, such as a ureteroscope, cystoscope, nephroscope, or another endoscopic device. In some embodiments, the medical device 20 can be a LithoVue® endoscopic device or other endoscope. In some embodiments, the medical device 20 can include a temperature sensor that provides intraluminal temperature feedback to the fluid management system 10, a pressure sensor that provides intraluminal pressure feedback to the fluid management system 10, and / or a camera that provides visual feedback. Some particular and / or additional features of the fluid management system 10 and / or medical device 20 shown in FIG. 1 may not be specifically mentioned with respect to FIG. 1 but are discussed below and / or with respect to other figures. Such features are shown in FIG. 1 for purposes of context.

[0040] Briefly, the fluid management system 10 may include an inflow pump 50 configured to pump and / or transfer fluid from a fluid source 34 (e.g., a fluid bag) to a medical device 20 and / or a treatment site within a patient's body at a fluid flow rate. In some cases, the fluid may pass through a fluid warming system 60 before entering the medical device 20. The fluid flow rate, fluid pressure, fluid temperature, and / or other operating parameters may be controlled or at least partially controlled by a controller 48. The controller 48 may be in electronic communication (e.g., wired or wireless) with the medical device 20, the inflow pump 50, and / or the fluid warming system 60 to provide control commands and / or communicate or receive data therebetween. For example, the controller 48 may receive data from the medical device 20, such as, but not limited to, pressure signals and temperature data. The controller 48 may use the received data to control the operating parameters of the inflow pump 50 and / or the fluid warming system 60.

[0041] The fluid management system 10 further includes a fluid management unit. An exemplary fluid management unit can include one or more fluid container supports, each supporting one or more fluid sources 34 (e.g., one or more fluid bags). The fluid container supports can accommodate fluid sources 34 of various sizes, such as, for example, 1 liter (L) to 5 liters of fluid sources (e.g., fluid bags). In some embodiments, the fluid management unit can be mounted on a rolling stand that can include multiple wheels to facilitate easy movement of the fluid management unit during use. However, it will be understood that the fluid sources 34 can be suspended from other locations depending on clinical preference. The fluid container supports can extend from the rolling stand and / or the controller 48 and include one or more hooks from which one or more fluid sources 34 can be suspended.

[0042] In some embodiments, the fluid management unit includes an outflow pump or vacuum pump 24 and a collection container 26 in fluid communication with the collection drape 28. In some embodiments, the vacuum pump 24 can include multiple vacuum pumps. In some embodiments, the collection container 26 can include multiple containers, canisters, and / or other vessels that can be fluidly connected to each other and / or to the vacuum pump 24. In some embodiments, the collection drape 28 can include multiple collection drapes. The vacuum pump 24 can be operatively and / or electronically connected to the controller 48. In some embodiments, the vacuum pump 24 can be located adjacent to and / or near the collection container 26, as shown in FIG. 1 . In some embodiments, the vacuum pump 24 can be located within the fluid management system 10. Other configurations are also contemplated.

[0043] The fluid management system 10 may further include one or more user interface components, such as a touch screen interface 42. The touch screen interface 42 includes a display 44 and may include switches or knobs in addition to touch functionality. In some embodiments, the controller 48 may include the touch screen interface 42 and / or the display 44. The touch screen interface 42 allows a user to input / adjust various functions of the fluid management system 10, such as, for example, system fluid pressure, fluid temperature, or inflow pump speed (e.g., revolutions per minute (rpm)), which may be correlated to flow rate. The user may configure parameters and alarms (such as, but not limited to, system pressure limits, inflow pump speed limits, intraluminal pressure limits, etc.), information to be displayed, etc. The touch screen interface 42 allows a user to add, modify, and / or discontinue the use of various modular systems within the fluid management system 10. The touch screen interface 42 may be used to change the fluid management system 10 between automatic and manual modes for various procedures. It is contemplated that other systems configured to accept user input may be used instead of or in addition to the touch screen interface 42.

[0044] As will be appreciated by those skilled in the art, the touch screen interface 42 can be configured to include selectable areas, such as buttons, and / or provide functionality similar to physical buttons. The display 44 can be configured to show icons for the modular systems and devices included within the fluid management system 10. Additionally, the display 44 can include a flow rate indicator. The flow rate indicator can be determined based on a desired threshold for flow rate set by the user prior to the procedure, a known typical value, or the like. In some embodiments, operating parameters can be adjusted by touching corresponding portions of the touch screen interface 42. The touch screen interface 42 can display visual and / or audible alerts when parameters (e.g., pump speed, flow rate, pressure, temperature) exceed or fall below predetermined thresholds and / or ranges. The touch screen interface 42 can be configured to display any other information the user may determine is advantageous during the procedure. In some embodiments, the fluid management system 10 can include additional user interface components, such as an optional foot pedal 46, a heater user interface, a fluid control interface, or other devices for manually controlling the various modular systems. For example, pump speed, flow rate, and / or system pressure can be manually controlled using optional foot pedal 46. Some exemplary displays and other user interface components are described in commonly assigned U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," the entire disclosure of which is incorporated herein by reference.

[0045] The touchscreen interface 42 can be operatively connected to or part of the controller 48. The controller 48 can be a computer, tablet computer, or other processing device. The controller 48 can be operatively connected to one or more system components, such as the inflow pump 50, the fluid warming system 60, and the fluid loss management system. In some embodiments, these features can be integrated into a single unit. The controller 48 is capable of and configured to perform various functions, such as calculations, control, computations, and displays. The controller 48 also has the ability to track and store data regarding the operation of the fluid management system 10 and its components. In an exemplary embodiment, the controller 48 includes wired and / or wireless network communication capabilities, such as Ethernet or Wi-Fi, that allow the controller 48 to connect to a local area network. The controller 48 can accept signals from one or more of the sensors in the fluid management system 10. In some embodiments, the controller 48 can communicate with a database for purposes of best practice recommendations and maintaining patient records, which can be displayed to a user on the display 44.

[0046] To regulate the flow rate or pressure of fluid through the fluid management system 10, the fluid management unit may include one or more pressurizing or flow generating devices, such as an inflow pump 50. In some embodiments, the inflow pump 50 may be a peristaltic pump. In some embodiments, the inflow pump 50 may include multiple pumps or more than one pump. The inflow pump 50 may be electrically powered and may receive power from a line power source, such as a wall outlet, an external or internal power storage device, such as a disposable or rechargeable battery, and / or an internal power source. The inflow pump 50 may be operated at any desired speed sufficient to deliver fluid at a target system pressure and / or target fluid flow rate. As mentioned herein, the controller 48 may be configured to automatically adjust one or more outputs to control the inflow pump 50. In some embodiments, the controller 48 may include a proportional-integral-derivative (PID) controller responsive to one or more outputs to control the inflow pump 50. In some embodiments, the one or more outputs may include a proportional error rate, an integral error rate, a derivative error rate, and / or a sampling time. In some embodiments, the sampling time can be from about 1 millisecond to about 100 milliseconds (ms), from about 3 ms to about 90 ms, from about 5 ms to about 80 ms, from about 10 ms to about 60 ms, from about 15 ms to about 50 ms, etc.

[0047] In some embodiments, one or more outputs for controlling the inflow pump 50 can be adjusted manually, for example, through an optional foot pedal 46, a touch screen interface 42, or a separate fluid controller. While not specified, the controller 48 can include a separate user interface including buttons that allow a user to increase or decrease the speed and / or output of the inflow pump 50. In some embodiments, the fluid management system 10 can include multiple pumps with different flow capabilities. Because the parameters and / or characteristics of the fluid management system 10 are generally known in advance, the inflow pump speed can be correlated to the flow rate within the fluid management system 10. Additionally or alternatively, in some embodiments, the fluid management system 10 can include a flow sensor 77 (e.g., FIG. 4 ) for measuring the actual fluid flow rate. The flow sensor 77 can be operatively connected to the controller 48, and data from the flow sensor 77 can be used by the controller 48 to modify selected system parameters.

[0048] The inflow pump speed, fluid flow rate, and / or system pressure can be displayed on the display 44 at any given time to provide operating room (OR) visibility of any changes. If OR staff notices a change in the inflow pump speed, fluid flow rate, and / or system pressure that is either too high or too low, the user can manually adjust the inflow pump 50 and / or one or more outputs to control the inflow pump speed, fluid flow rate, and / or system pressure back to a preferred level. In some embodiments, the fluid management system 10 and / or controller 48 can monitor and automatically adjust one or more outputs for controlling the inflow pump 50 as discussed herein.

[0049] 2-3 illustrate aspects of a medical device 20 that can be used in conjunction with the fluid management system 10. In some embodiments, the fluid management system 10 and / or the controller 48 can be configured to operate with multiple medical devices 20 and / or detect which of these medical devices 20 are fluidly connected to the inflow pump, as discussed herein. In some embodiments, the multiple medical devices 20 can include one or more endoscopes, such as a ureteroscope, a cystoscope, a nephroscope, or another endoscopic device. The following discussion will refer to a singular medical device 20 for convenience and brevity. It will be understood that any or all features and / or configurations described with respect to the medical device 20 can apply to one, some, or all of the multiple medical devices 20.

[0050] In some embodiments, the medical device 20 can be configured to deliver fluid from the fluid management system 10 and / or the inflow pump 50 to a treatment site through an elongate shaft 76 configured to access the treatment site within a patient's body. In some embodiments, the inflow pump 50 can be in fluid communication with the medical device 20 and / or the elongate shaft 76. The elongate shaft 76 can include one or more working lumens for receiving fluid flow and / or other medical devices therethrough. The medical device 20 can be connected to the fluid management system 10 through one or more supply lines 78 (e.g., tubing), as seen in FIG. 1 , for example.

[0051] In some embodiments, the medical device 20 can be in electronic communication with a workstation 81 through a wired connection 79. The workstation 81 can include, among other features, a touch panel computer 83, an interface box 85 for accepting the wired connection 79, a cart 87, and a power supply 89. In some embodiments, the interface box 85 can be configured to have a wired or wireless communication connection 91 with the controller 48 of the fluid management system 10. The touch panel computer 83 can include at least a display screen and an image processor. In some embodiments, the workstation 81 can be a multi-use component (e.g., used for more than one procedure), whereas the medical device 20 can be a single-use device, although this is not required. In some embodiments, the workstation 81 can be omitted, and the medical device 20 can be electronically coupled directly to the controller 48 of the fluid management system 10.

[0052] In some embodiments, one or more supply lines 78 from the fluid management system 10 to the medical device 20 can be formed from a material that helps dampen the peristaltic movement achieved by the inflow pump 50. In some embodiments, the supply lines 78 can be formed from small diameter tubing, less 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 based on the application. The supply lines 78 and / or tubing can be disposable and provided sterile and ready to use. 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 to heat and control fluid flow to the medical device 20, while another type of tubing can be used for perfusion within the body and / or treatment site.

[0053] As seen in FIG. 2 , the medical device 20 can include one or more sensors proximal to the distal end 80 of the elongate shaft 76. For example, the medical device 20 can include a distal pressure sensor 74 at the distal end 80 of the elongate shaft 76 for measuring intraluminal pressure within the treatment site. The medical device 20 can further include other sensors, such as a temperature sensor 72, a fiber Bragg grating optical fiber 75 for detecting stress, and / or an antenna or electromagnetic sensor 93 (e.g., a position sensor). In some embodiments, the distal end 80 of the elongate shaft 76 of the medical device 20 can further include at least one camera 70 to provide a visual feed to a user on a display screen of a touch panel computer 83. In another embodiment, the medical device 20 can include two cameras 70 with different communication requirements or protocols so that each can convey different information to the user. When so provided, the user can optionally switch between these cameras 70 through the touch screen interface 42 and / or the touch panel computer 83. Although not specified, the elongate shaft 76 may include one or more working lumens for receiving fluids and / or other medical devices.

[0054] In some embodiments, the location of the distal end 80 of the elongate shaft 76 can be tracked during use. For example, the mapping and navigation system can include an operating table (or other procedure or examination table or chair, etc.) configured to act as an electromagnetic generator to generate a magnetic field of known geometry. Alternatively or additionally, an electromagnetic generator separate from the operating table can be provided. The operating table and / or electromagnetic generator can be coupled to a control unit that can include, among other features, a processor, memory, a display, and input means. A position sensor (e.g., electromagnetic sensor 93) or other antenna can be incorporated into the distal end 80 of the elongate shaft 76 of the medical device 20. The position sensor can be configured for use in sensing the location of the position sensor in the magnetic field of the mapping and navigation system. In some embodiments, the position sensor can be electronically coupled to the workstation 81. When the position sensor is within the magnetic field, the location of the position sensor relative to the electromagnetic field source (e.g., the operating table and / or the electromagnetic generator) can be mathematically determined. The workstation 81 and the control unit can communicate to determine the location of the position sensor relative to the patient.

[0055] The medical device 20 includes a handle 82 coupled to the proximal end of the elongate shaft 76. In some embodiments, the handle 82 can have a fluid flow start / stop switch that allows a user to control when fluid flows through the medical device 20 and into the treatment site. The handle 82 can further include other buttons that perform various other functions. For example, in some embodiments, the handle 82 can include a button for controlling the temperature of the fluid. While this exemplary embodiment describes a ureteroscope, it will be understood that the features detailed above can be integrated directly into a cystoscope, endoscope, hysteroscope, or virtually any device with imaging capabilities. In some embodiments, the medical device 20 can further include a working lumen access port 88 fluidly connected to at least one of its one or more working lumens. For example, medical instruments or tools used during a procedure can be inserted into one or more working lumens of the medical device 20 through the working lumen access port 88.

[0056] In some embodiments, the fluid management system 10 can include a fluid warming system 60 for heating fluid delivered to the patient. The fluid warming system 60, with some details shown in FIG. 4 , can include a heater 62 and a heater cassette 64. The heater cassette 64 can be configured to be a single-use heater cassette 64, whereas the heater 62 can be reused for multiple procedures. For example, the heater cassette 64 can isolate fluid flow so that the heater 62 can be reused with minimal maintenance. The heater cassette 64 can be formed, for example, from polycarbonate or any high-heat-rated biocompatible plastic, and can be formed as a single unitary and / or integrally formed part or multiple parts permanently joined together. In some embodiments, the heater cassette 64 can include a fluid inlet port 61 and a fluid outlet port 63 positioned on a side thereof. Each of the fluid inlet port 61 and the fluid outlet port 63 can be configured to couple to a supply line 78 of the fluid management system 10. For example, the fluid inlet port 61 can connect the fluid source 34 to the fluid warming system 60 (through the inflow pump 50), while the fluid outlet port 63 can connect the fluid warming system 60 to the medical device 20, each of these connections being through a supply line 78.

[0057] In some embodiments, the heater cassette 64 can include an internal flow path along which a fluid can flow from the fluid inlet port 61 to the fluid outlet port 63. The heater cassette 64, the channel, and / or the internal flow path can include one or more fluid flow paths. In some embodiments, the channel can pass through a susceptor 66, which can enable the fluid to be heated by induction heating. When the heater cassette 64 is coupled with the heater 62, the susceptor 66 can be configured to be disposed within an induction coil 68. Other fluid heating system configurations and methods can be used as desired. For example, the heater 62 can include one or more heat sources in the supply line 78, such as, for example, a platen system using electrical energy or a series coil. Heating can be specifically designed and adapted to the input pump speed, fluid flow rate, and / or system pressure required for a particular application of the fluid management system 10. Some exemplary fluid warming systems are described in commonly assigned U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," the entire disclosure of which is incorporated herein by reference.

[0058] Although not specified, the fluid warming system 60 can include a heater user interface that is separate from the touch screen interface 42. The heater user interface can simply be a display screen that provides a digital display of the internal temperature of the heater 62. In another embodiment, this user interface can further include temperature adjustment buttons for increasing or decreasing the temperature of the heater 62. In this embodiment, the heater user interface and / or display screen can show the current temperature of the heater 62, as well as the target temperature to be reached. It should be noted that all information output from the fluid warming system 60 can be communicated directly to the display 44, such that a heater user interface is not necessary.

[0059] The fluid warming system 60 can include one or more sensors configured to monitor the fluid flowing therethrough. For example, a temperature sensor 65 can be mounted within the fluid warming system 60 to detect the temperature of the fluid flowing through the heater cassette 64. The temperature sensor 65 can be positioned at or near the fluid inlet port 61 and / or the fluid outlet port 63. In some embodiments, the temperature sensor 65 can 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 can be positioned in the middle of the susceptor 66 to detect the progression of the temperature increase of the fluid within the heater cassette 64. The temperature sensor 65 can transmit any information remotely to the display 44 or, if so provided, can transmit information to the heater user interface and / or its display screen. In another embodiment, the temperature sensor 65 may be hardwired to the heater user interface (if provided), in which case the heater user interface may remotely transmit desired information to the display 44. Alternatively or additionally, the temperature sensor 65 may be hardwired to and / or with the controller 48.

[0060] The heater 62 may further include at least one pressure sensor 67 configured to monitor system pressure and / or an air bubble sensor 69 configured to monitor fluid flowing through the system for air bubbles. The heater cassette 64 may include a corresponding pressure sensor interface 71 and air bubble sensor interface 73 that enable the at least one pressure sensor 67 and air bubble sensor 69, respectively, to monitor fluid flowing through the heater cassette 64 when it is coupled to the fluid warming system 60. The at least one pressure sensor 67 and / or air bubble sensor 69 may remotely and / or automatically transmit information to the controller 48, the display 44, and / or to a heater user interface and / or its display screen, if so provided. The controller 48 may be configured to receive a pressure signal from the at least one pressure sensor 67 corresponding to the system pressure within the fluid management system 10. In some embodiments, at least one pressure sensor 67 and / or bubble sensor 69 may be hardwired to the heater user interface (if provided), in which case the heater user interface may remotely transmit desired information to the display 44. Alternatively or additionally, at least one pressure sensor 67 and / or bubble sensor 69 may be hardwired to and / or with the controller 48.

[0061] In some embodiments, the at least one pressure sensor 67 can include one, two, three, four, or more pressure sensors. In some embodiments having two or more pressure sensors, the individual pressure sensors can be spaced apart from one another. In some embodiments, the at least one pressure sensor 67 can be located downstream of the inflow pump 50. In some embodiments, the at least one pressure sensor 67 can be located upstream of the medical device 20. In some embodiments, the at least one pressure sensor 67 can be located downstream of the inflow pump 50 and upstream of the medical device 20. In some embodiments, the at least one pressure sensor 67 can be configured to detect system pressure within the fluid management system 10 downstream of the inflow pump 50.

[0062] In some embodiments, the heater cassette 64 can act as a fluid reservoir as a whole. While not explicitly shown, the fluid reservoir of the heater cassette 64 can include a vibration dampener to reduce peristaltic vibrations and one or more air traps to remove air bubbles before and / or after heating the fluid flowing through the heater cassette 64. In some embodiments, the vibration dampener and the one or more air traps can collectively act as a fluid reservoir. The fluid level in the fluid reservoir of the heater cassette 64 can rise and fall based on the ratio between the inflow of fluid pumped into the heater cassette 64 and the outflow of fluid (flowing to the medical device 20 and / or patient) from the heater cassette 64. The outflow of fluid from the heater cassette 64 can be controlled and / or regulated by a pressure gradient or pressure difference between the fluid reservoir of the heater cassette 64 and the distal end 80 of the elongate shaft 76, and further by hydraulic resistance along the flow path.

[0063] In some embodiments, only system pressure is available as an input to the controller 48 (e.g., no distal pressure sensor 74 is present in the medical device 20). In such embodiments, the fluid level in the fluid reservoir of the heater cassette 64 is controlled by the behavior shown in FIG. 5. In FIG. 5, the controller 48 sends one or more inputs to the inflow pump 50 (e.g., FIG. 1) to control the inflow pump speed 100. The inflow pump speed 100 contributes to the inflow of fluid into the fluid reservoir 102. The fluid reservoir 102 may have a reservoir air pressure 104 (when the fluid reservoir 102 is not filled with fluid). A pressure signal and / or system pressure 110 obtained by at least one pressure sensor 67 is sent from the fluid reservoir 102 back to the controller 48, where the controller 48 evaluates the pressure signal and / or system pressure 110 and maintains or adjusts one or more outputs to the inflow pump 50 as needed to maintain desired operation. Fluid may flow from the fluid reservoir 102 through one or more operating lumens to a treatment site 112 (e.g., a body cavity, a ureter, a bladder, a kidney, etc.) (e.g., reference numeral 106). Backpressure 108 may affect the fluid level and / or pressure within the fluid reservoir 102, and thus may affect the system pressure 110. Fluid may also drain and / or flow away from the treatment site 112, and this flow may adversely affect the backpressure 108 and / or the system pressure 110. This operating configuration may be used with any applicable endoscopic device lacking a distal pressure sensor 74, and this configuration may be referred to as an “independent control configuration.” Thus, in at least some embodiments, the controller 48 may be configured to operate in the independent control configuration based on which of the multiple medical devices 20 are fluidly connected to the inflow pump 50 and / or in the absence of an intracavity pressure signal from and / or the distal pressure sensor 74.

[0064] In some embodiments, the independent control configuration shown in FIG. 5 can be modified by the presence of a distal pressure sensor 74 and / or an intraluminal pressure 116. As seen in FIG. 5, the intraluminal pressure 116 can be transmitted from the treatment site 112 by the distal pressure sensor 74 to the controller 48, in which case the intraluminal pressure 116 can be incorporated into the overall control logic. The controller 48 maintains or adjusts one or more outputs to the inflow pump 50 as needed to maintain desired operation. For example, the intraluminal pressure 116 from the distal pressure sensor 74 can be used to limit pressure within the treatment site by adjusting one or more outputs to the inflow pump 50 to control the inflow pump speed 100. This operation configuration can be used with any applicable endoscopic device having a distal pressure sensor 74, and this configuration may be referred to as an “interoperable control configuration.” Thus, in at least some embodiments, the controller 48 can be configured to operate in an interoperable control configuration based on which of the multiple medical devices 20 is fluidly connected to the inflow pump 50 and / or in the presence of a distal pressure sensor 74 and / or an intraluminal pressure 116 signal therefrom.

[0065] In each configuration, the fluid management system 10 can be operated in one of two different modes: a "pressure control mode" or a "flow compensation mode." In the pressure control mode, the controller 48 will adjust various system parameters and / or one or more outputs to the inflow pump 50 to hold and / or maintain the system pressure at a system pressure setpoint, which a user can enter on the touch screen interface 42. In some embodiments, the system pressure setpoint can be automatically set and / or selected based on which of multiple medical devices 20 are fluidly connected to the inflow pump 50. As discussed herein, the system pressure can be measured by at least one pressure sensor 67 within the fluid management unit.

[0066] In some embodiments, the fluid management system 10 can be fluidly connected to a first working lumen of the medical device 20. As such, the fluid management system 10 can be configured to control the inflow of fluid therefrom through the medical device 20 to a treatment site. In at least some embodiments, using the first working lumen of the medical device 20, a medical instrument or tool can be inserted through the medical device 20 to a treatment site. Insertion of the medical instrument or tool can partially occlude the first working lumen, thus affecting the flow and / or pressure characteristics of the inflow of fluid.

[0067] As shown in FIG. 6A , when the fluid management system 10 is operating in the pressure control mode of the independent control configuration, the flow rate of the influent fluid through the first working lumen increases after the influent pump 50 is activated. When a medical instrument or tool is inserted into the first working channel, the flow rate, which correlates to the speed (e.g., revolutions per minute (rpm)) of the influent pump 50, begins to decrease and stabilizes once the medical instrument or tool is fully inserted. However, the flow rate of the influent fluid is lower than that in an unoccluded first working lumen. At the same time, as shown in FIG. 6B , the system pressure 110 is maintained and / or maintained by the controller 48 due to the pressure signal and / or system pressure 110 being received by the controller 48. Once the medical instrument or tool is fully inserted, the system pressure 110 increases slightly to restore at least a portion of the original flow rate, but the system pressure 110 will be limited by the system pressure limit and / or medical device damage limit. In some embodiments, the system pressure limit and / or medical device damage limit may be entered and / or selected by a user using the touch screen interface 42. In some embodiments, the system pressure limit and / or medical device damage limit may be automatically set and / or selected based on which of the plurality of medical devices 20 are fluidly connected to the inflow pump 50.

[0068] If the fluid management system 10 instead operates in the flow compensation mode of the independent control configuration, the system pressure 110 may increase accordingly before flow is restored. The response time for restoring flow may be improved by incorporating the intraluminal pressure 116 from the distal pressure sensor 74, if available. The intraluminal pressure 116 allows a pressure drop (e.g., a pressure gradient) across the fluid management system 10 to be detected more quickly than the system pressure 110 alone. Thus, when the fluid management system 10 operates in the flow compensation mode of the interoperable control configuration, the system pressure 110 will simply increase when a drop in intraluminal pressure 116 is detected, as shown in FIG. 7B, and flow will be restored more quickly and / or closer to its original level, as shown in FIG. 7A.

[0069] In some embodiments, when operating in an interoperable control configuration, the controller 48 can be configured to selectively perform irrigation in response to a system pressure setpoint, a system pressure limit, and a medical device damage limit. In at least some embodiments, the system pressure setpoint, the system pressure limit, and the medical device damage limit can be automatically selected based on which of the multiple medical devices 20 is fluidly connected to the inflow pump 50. The irrigation flow can be a discrete fluid bolus delivered to the treatment site through a first working lumen of the medical device 20. In some embodiments, the irrigation flow can be delivered to the treatment site through the aforementioned working lumen of the medical device 20 or a different working lumen of the medical device 20. In some embodiments, the irrigation can be generated, activated, and / or initiated as needed using the touch screen controller 42. In some embodiments, the irrigation can be generated, activated, and / or initiated as needed using the optional foot pedal 46. In some embodiments, the irrigation can be configured to increase the system pressure 110 by a predetermined amount for a predetermined period of time.

[0070] 8A-8D illustrate various configurations for irrigation. When performing irrigation, the allowable fluid pressure can be related to medical decisions made by the attending physician and / or the design limits of the equipment involved. In some embodiments, the user interface of controller 48 can include optional irrigation prioritization, which can be activated by the attending physician where and / or when it is desired to exceed physician-preset and / or preselected system pressure limits.

[0071] Figure 8A illustrates the situation where the fluid management system 10 is operating at a system pressure setpoint and a wash is activated. In the case illustrated in Figure 8A, the change in fluid pressure associated with the wash is less than the system pressure limit because the system pressure setpoint is far enough below the system pressure limit to accommodate the pressure change from the wash. Therefore, the wash is allowed to run normally and fully and does not require wash prioritization to be activated and / or run.

[0072] FIG. 8B illustrates a case in which the fluid management system 10 is operating at a system pressure setpoint closer to the system pressure limit, and the pressure change associated with the wash is greater than the difference between the system pressure limit and the system pressure setpoint. In this case, if the controller 48 determines that the predetermined wash volume would exceed the system pressure limit when the wash is initiated, a notification is displayed and a wash priority input is available and / or enabled on the user interface. In the case illustrated in FIG. 8B, wash control priority is not selected. Therefore, a predetermined wash volume that exceeds the system pressure limit is throttled to the system pressure limit. Thus, the wash is only allowed to run partially up to the system pressure limit.

[0073] FIG. 8C illustrates a similar case to FIG. 8B, except that a wash control override has been selected and / or activated on the user interface. Notably, in the case of FIG. 8C, the pressure change associated with the wash is greater than the difference between the system pressure limit and the system pressure setpoint, but less than the difference between the medical device damage limit and the system pressure setpoint. In this case, if the controller 48 determines that a predetermined amount of wash would exceed the system pressure limit when the wash is activated, a notification is displayed and a wash override input is available and / or enabled on the user interface. Activation of the wash override input allows the controller to exceed the system pressure limit by a predetermined amount up to the medical device damage limit. Because the wash override has been approved, the wash is allowed to run fully, and a notification is displayed during the time the wash exceeds the system pressure limit.

[0074] 8D illustrates a case where the pressure change associated with a wash is greater than the difference between the system pressure limit and the system pressure setpoint, and greater than the difference between the medical device damage limit and the system pressure setpoint. In this case, if the controller 48 determines that a predetermined amount of wash would exceed the system pressure limit when the wash is activated, a notification is displayed and a wash override input is available and / or enabled on the user interface. Activation of the wash override input allows the controller 48 to exceed the system pressure limit by a predetermined amount up to the medical device damage limit. Because the wash control override is acknowledged, the wash is allowed to run partially up to the medical device damage limit, and a notification is displayed during the time the wash exceeds the system pressure limit. Any predetermined amount of wash that exceeds the medical device damage limit is throttled to the medical device damage limit.

[0075] In some embodiments, the fluid management system 10 includes a distal pressure sensor 74 disposed at the distal end 80 of the medical device 20, as discussed herein. In some embodiments, the distal pressure sensor 74 can be configured to monitor an increase in in-situ pressure caused by irrigation. The controller 48 can be configured to limit a predetermined amount and / or a predetermined duration of irrigation so that the in-situ pressure remains below a predetermined in-situ pressure limit. In at least some embodiments, the in-situ pressure limit can be set by a user and / or attending physician using the user interface and / or touch screen interface 42.

[0076] It will be appreciated that, for both independent and interoperable control configurations, the relationship between pressure and flow rate can vary significantly across a variety of different medical devices supported and / or to be supported by the fluid management system 10. For example, FIG. 9 shows data curves relating system pressure and flow rate for each of a plurality of medical devices 20 (flow rate is correlated to revolutions per minute (rpm) of the inflow pump 50; rpm data points can be swapped for flow rate to establish these data curves). Similarly, while FIG. 9 shows data curves for three different medical devices, it will be appreciated that additional data curves can be included in and / or used by the controller 48. In some embodiments, the plurality of medical devices 20 can include different types of medical devices, different sizes of medical devices, and / or different brands or manufacturers of a single type of medical device. Other configurations are also contemplated.

[0077] FIG. 9 illustrates a data curve for a first medical device having an empty and / or unoccluded working lumen at 200 and a data curve for a first medical device having a medical instrument or tool disposed therein at 202; a data curve for a second medical device having an empty and / or unoccluded working lumen at 210 and a data curve for a second medical device having a medical instrument or tool disposed therein at 212; and a data curve for a third medical device having an empty and / or unoccluded working lumen at 220 and a data curve for a third medical device having a medical instrument or tool disposed therein at 222. These data curves can be based on known and / or desktop evaluation data. As can be seen in FIG. 9, each medical device 20 and / or each medical device 20 with an added medical instrument or tool defines a different relationship and / or line on the graph. These data curves can be pre-loaded into the controller 48. Using these pre-loaded data curves, the controller 48 can be configured to determine which of the plurality of medical devices 20 are fluidly connected to the inflow pump 50 based on the system pressure within the fluid management system 10 and the revolutions per minute (rpm) of the inflow pump 50. The controller 48 can be configured to compare current and / or actual system pressure and inflow pump speed (e.g., flow rate) data to known and / or pre-loaded data curves for system pressure and inflow pump speed (e.g., flow rate) for the plurality of medical devices 20 to detect which of the plurality of medical devices 20 are fluidly connected to the inflow pump 50. Other configurations are contemplated.

[0078] In some embodiments, the fixed volume of the heater cassette 64 fluid reservoir may not be able to accommodate flow compensation mode for all available medical devices. For example, a medical device with a larger bore working lumen may be able to reach a higher flow rate, but the inflow pump 50 may not be able to increase speed sufficiently to reach a higher system pressure. In some embodiments, a fuzzy logic algorithm may be utilized to facilitate switching between pressure control mode and flow compensation mode. In some embodiments, the controller 48 may be configured to automatically enable flow compensation mode based on which of multiple medical devices 20 are fluidly connected to the inflow pump 50.

[0079] 10 illustrates an example of a fuzzy logic algorithm that may be used by the controller 48. The controller 48 calculates the power factor (OF) as a result of the revolutions per minute (rpm) (or flow rate, if desired) of the inlet pump 50 and the system pressure. For example, the controller 48 may calculate the power factor (OF) by taking the revolutions per minute (rpm) of the inlet pump 50 and dividing it by the system pressure. Other configurations and / or variables are also contemplated for use in calculating the power factor (OF), including, but not limited to, flow rate, inlet to outlet fluid volume, rate of pressure change, rate of rpm change, etc.

[0080] Next, the controller 48 compares the output coefficient (OF) to a set of known ranges (such as range 1, range 2, range 3). In one example, range 1 can correspond to ((OF>0) and (OF<x)), range 2 can correspond to ((OF≧x) and (OF<y)), and range 3 can correspond to ((OF≧y) and (OF<z)). Additional ranges can be added and / or included as needed. In some embodiments, each known range (such as range 1, range 2, range 3) can correspond to one of a plurality of medical devices 20. Each known range can define one or more inputs (such as Kp, Ki, Kd, SR) for controlling the inflow pump 50. In the example being described, Kp corresponds to the proportional error rate, Ki corresponds to the integral error rate, Kd corresponds to the derivative error rate, and SR corresponds to the sampling rate. Other configurations are contemplated. Each known range can have corresponding different values (such as each from a to d, each from e to h) of the Kp output, Ki output, Kd output, and SR output that are used to adjust a parameter of the fluid management system 10 (such as the revolutions per minute rpm of the inflow pump 50). For example, when the controller 48 determines that the output coefficient is within range 1 (and thus that the first medical device type is attached to the fluid management system 10), the output is automatically set to the first Kp value, the first Ki value, the first Kd value, and the first SR value. When the controller 48 determines that the output coefficient is within range 2 (and thus that the second medical device type is attached to the fluid management system 10), the output is automatically set to the second Kp value, the second Ki value, the second Kd value, and the second SR value. When the controller 48 determines that the output coefficient is within range 3 (and thus that the third medical device type is attached to the fluid management system 10), the output is automatically set to the third Kp value, the third Ki value, the third Kd value, and the third SR value.

[0081] In some embodiments, the system pressure setpoints, system pressure limits, medical device damage limits, etc. may be automatically selected and / or set based on which of the plurality of medical devices 20 are fluidly connected to the inflow pump 50. In some embodiments, the system pressure setpoints, system pressure limits, medical device damage limits, etc. may be associated with a set of known ranges. For example, the controller 48 may automatically select a first set of settings for the system pressure setpoints, system pressure limits, medical device damage limits, etc. when the output factor (OF) is within range 1, may automatically select a second set of settings for the system pressure setpoints, system pressure limits, medical device damage limits, etc. that are different from the first set of settings when the output factor (OF) is within range 2, and may automatically select a third set of settings for the system pressure setpoints, system pressure limits, medical device damage limits, etc. that are different from both the first and second set of settings when the output factor (OF) is within range 3. Other configurations are also contemplated.

[0082] One or more outputs (for example, Kp, Ki, Kd, ​​and SR) are then sent to a PID controller associated with controller 48. Controller 48 and / or the PID controller can send an inlet pump speed (e.g., revolutions per minute, rpm) to inlet pump 50 based on the detection range and thus the preset output values ​​(i.e., Kp, Ki, Kd, ​​and SR). In some embodiments, inlet pump 50 and at least one pressure sensor 67 may be referred to together as the "plant." Thus, inlet pump speed data can be sent to the plant by controller 48 and / or the PID controller. Because system pressure is at least partially dependent on the inlet pump speed, the inlet pump speed (e.g., revolutions per minute, rpm) and system pressure are fed back into controller 48 and / or a fuzzy logic algorithm. The system pressure is also compared against a system pressure setpoint to determine an error difference between the system pressure and the system pressure setpoint, which can be sent to a processor and used to refine one or more outputs, as needed. In some embodiments, the fluid management system 10, controller 48, and / or PID controller attempt to adapt their settings to provide the fastest response time with the most stability to changes in the system (e.g., when a medical device is inserted, withdrawn, or changed).

[0083] Those skilled in the art will recognize that the present disclosure may appear in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail may be made without departing from the scope and spirit of the present invention as set forth in the claims.

[0084] The various components of the systems disclosed herein and the materials that can be used for the various elements thereof can include those generally associated with medical devices. For purposes of simplicity, the following discussion will be with respect to systems. However, the devices and methods described herein are not intended to be limiting, as this discussion can be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, fluid management systems, medical devices, elongate shafts, inflow pumps, fluid warming systems, controllers, supply lines, handles, workstations, display screens, fluid sources, collection containers, and / or elements or components thereof.

[0085] In some embodiments, the system and / or its components may be fabricated from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials.

[0086] Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, e.g., HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (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 (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (EMS AmericanThe sheath may comprise any suitable material, such as GRILAMID® available from Grilon), 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 50A), polycarbonate, polyurethane silicone copolymer (e.g., ElastEon® 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 compounded with a liquid crystal polymer (LCP). For example, the mixture may contain about 6 percent LCP.

[0087] Some examples of suitable metals and metal alloys include stainless steels such as 304V stainless steel, 304L stainless steel, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic nitinol and / or superelastic nitinol, other nickel alloys, for example, nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N06022 such as HASTELLOY® C-22®, and HASTELLOY® C-22®). 276®, and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS:N10276, such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® 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 (e.g., UNS:R30003, such as ELGILOY® and PHYNOX®), platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0088] In at least some embodiments, portions or all of the system and / or its components can be doped with, manufactured with, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the system in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymeric materials filled with radiopaque fillers. Additionally, other radiopaque marker bands and / or coils can be incorporated into the system design to achieve the same results.

[0089] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is provided within the systems and / or other elements disclosed herein. For example, the systems and / or components or portions thereof can be fabricated from materials that do not substantially distort images and do not cause substantial artifacts (i.e., gaps in the images). For example, certain ferromagnetic materials may not be suitable due to their potential for producing artifacts in MRI images. The systems or portions thereof can also be fabricated from materials that can be imaged by MRI machines. Some materials that exhibit these attributes include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), and nitinol, among others.

[0090] In some embodiments, the endoprostheses and / or other components disclosed herein can contain and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents include antithrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies that function to inhibit smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetics (such as lidocaine, bupivacaine, and ropivacaine), and the like. anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation enhancers); vascular cell growth inhibitors (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 a growth factor and a cytotoxin, bifunctional molecules composed of an antibody and a cytotoxin); cholesterol-lowering agents, vasodilators, and agents that interfere with endogenous vasoactive mechanisms.

[0091] It should be understood that the present disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, where appropriate, the use of any of the features of one illustrative embodiment when used in another embodiment. The scope of the present disclosure is, of course, defined in the language in which the appended claims are expressed. [Explanation of symbols]

[0092] 10 Fluid Management Systems 20 Medical Devices 34 Fluid supply source 46 Optional foot pedal 48 Controller

Claims

1. 1. A fluid management system comprising: an inflow pump for providing fluid inflow to the medical device; at least one pressure sensor; a controller configured to receive a pressure signal from the at least one pressure sensor corresponding to a system pressure within the fluid management system; Including, the controller is configured to detect which one of a plurality of medical devices is fluidly connected to the inflow pump based on the pressure signal from the at least one pressure sensor and the revolutions per minute of the inflow pump. Fluid management systems.

2. 10. The fluid management system of claim 1, wherein the controller is configured to automatically adjust one or more outputs for controlling the inflow pump based on which one of the plurality of medical devices is fluidly connected to the inflow pump.

3. The fluid management system of claim 2 , wherein the controller comprises a PID controller responsive to the one or more outputs.

4. The fluid management system of any one of claims 1 to 3, wherein the controller calculates a power coefficient based on the revolutions per minute of the inlet pump and the system pressure.

5. The fluid management system of claim 4 , wherein the controller compares the output coefficient to a set of known ranges, each known range corresponding to one of the plurality of medical devices.

6. The fluid management system of claim 5 , wherein each known range has a different corresponding output power used to adjust the RPM of the inflow pump.

7. The fluid management system of claim 6 , wherein the outputs include a proportional error rate (Kp), an integral error rate (Ki), a differential error rate (Kd), and a sampling rate (SR).

8. 8. The fluid management system of claim 1, wherein the controller is configured to selectively perform flushing in response to a system pressure setpoint, a system pressure limit, and a medical device damage limit, the flushing being configured to increase the system pressure by a predetermined amount for a predetermined period of time.

9. The fluid management system of claim 8 , wherein the predetermined amount of cleaning that exceeds the system pressure limit is throttled to the system pressure limit.

10. 9. The fluid management system of claim 8, wherein if the controller determines that the predetermined amount of cleaning will exceed the system pressure limit, a notification is displayed and a cleaning override input is made available, and activation of the cleaning override input allows the controller to exceed the system pressure limit by the predetermined amount up to the medical device damage limit.

11. The fluid management system of claim 10 , wherein the predetermined amount of washing that exceeds the medical device damage limit is throttled to the medical device damage limit.

12. 9. The fluid management system of claim 8, wherein the system pressure setpoint, the system pressure limit, and the medical device damage limit are automatically selected based on which one of the plurality of medical devices is fluidly connected to the inflow pump.

13. 1. A fluid management system comprising: an inflow pump for providing fluid inflow to the medical device; at least one pressure sensor; a controller configured to receive a pressure signal from the at least one pressure sensor corresponding to a system pressure within the fluid management system; Including, the controller is configured to detect which one of a plurality of medical devices is fluidly connected to the inflow pump based on the pressure signal from the at least one pressure sensor and the revolutions per minute of the inflow pump; the controller is configured to automatically adjust one or more outputs for controlling the inflow pump based on which one of the plurality of medical devices is fluidly connected to the inflow pump; The controller is configured to selectively perform flushing in response to a system pressure setpoint, a system pressure limit, and a medical device damage limit that are automatically selected based on which one of the plurality of medical devices is fluidly connected to the inflow pump, and the flushing is configured to increase the system pressure by a predetermined amount for a predetermined period of time.

14. a distal pressure sensor disposed at a distal end of the one of the plurality of medical devices fluidly connected to the inflow pump; the distal pressure sensor is configured to monitor an increase in in situ pressure caused by the irrigation; 14. The fluid management system of claim 13, wherein the controller is configured to limit the predetermined amount and / or the predetermined duration of the cleaning such that in-situ pressure remains below a predetermined in-situ pressure limit.

15. The fluid management system of any preceding claim, wherein the at least one pressure sensor is positioned downstream of the inflow pump and upstream of the medical device.

Images