Fluid Monitoring System

Abstract

To provide alternative medical devices and fluid delivery systems.SOLUTION: A fluid management and medical device system may include a fluid management system and a medical device having one or more sensors proximate to the distal end of an elongate shaft of the medical device. A controller of the fluid management system may be configured to calculate a fluid deficit when the distal end of the elongate shaft is disposed within a patient and configured to automatically pause fluid deficit calculation when the distal end of the elongate shaft is removed from the patient. In some instances, the controller is configured to calculate the fluid deficit using rotational speed of the inflow pump in combination with a difference between a change in weight of a fluid supply source supplying a fluid to the fluid management system and a change in weight of a collection container collecting the fluid from the fluid management system.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 928,005, filed October 30, 2019, the entire disclosure of which is hereby incorporated by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to fluid management systems. More particularly, the present disclosure relates to systems and methods for monitoring fluid losses in and / or by fluid management systems. [Background technology]

[0003] Flexible ureteroscopy (fURS), gynecological endoscopic procedures, and other endoscopic procedures require fluid circulation for several reasons. Today's surgeons deliver fluid in a variety of ways, such as by hanging a fluid bag and using gravity to deliver the fluid, filling a syringe with the fluid and manually injecting it, or using a peristaltic pump to deliver fluid at a fixed pressure or flow rate from a reservoir through a fluid management system. The fluid management system can adjust the flow rate and / or pressure based on data collected from a treatment device, such as, but not limited to, an endoscope, when delivering fluid from a reservoir. With regard to 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] US Patent Application Publication No. 2018 / 0361055 Summary of the Invention [Means for solving the problem]

[0005] In a first example, a fluid management and medical device system can include a medical device including an elongate shaft configured to access a treatment site within a patient, one or more sensors proximal to a distal end of the elongate shaft, and a handle coupled to the proximal end of the elongate shaft. The fluid management and medical device system can also include a fluid management system including an inflow pump configured to pump fluid from a fluid source to the treatment site and a controller configured to calculate a fluid deficit when the distal end of the elongate shaft is positioned within the patient. The controller can be configured to automatically interrupt the fluid deficit calculation when the distal end of the elongate shaft is removed from the patient.

[0006] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to resume fluid deficit calculations when a signal from one or more sensors indicates that the distal end of the elongate shaft has been reinserted into the patient.

[0007] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to control the inflow pump based on a set of system operating parameters to maintain a target fluid flow rate or a target fluid pressure.

[0008] Additionally or alternatively to any of the examples disclosed herein, the controller can be configured to automatically reset the fluid deficit to zero after priming the fluid management system.

[0009] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to automatically initiate a fluid deficit calculation when a signal from one or more sensors indicates that the distal end of the elongate shaft has been inserted into the patient.

[0010] Additionally or alternatively to any example disclosed herein, the one or more sensors include a temperature sensor.

[0011] Additionally or alternatively, in any example disclosed herein, the one or more sensors include a pressure sensor.

[0012] Additionally or alternatively to any example disclosed herein, the one or more sensors include a temperature sensor and a pressure sensor.

[0013] In addition or in the alternative to any example disclosed herein, the fluid management system includes a vacuum pump and a collection container in fluid communication with the collection drape.

[0014] Additionally or alternatively to any example disclosed herein, the fluid deficit calculation continues uninterrupted as the fluid supply is replenished.

[0015] In a second example, in addition to or instead of any of the examples disclosed herein, a fluid management and medical device system can include a medical device including an elongate shaft configured to access a treatment site within a patient, one or more sensors proximal to a distal end of the elongate shaft, and a handle coupled to a proximal end of the elongate shaft. The fluid management and medical device system can also include a fluid management system including a fluid source operatively coupled to a supply load cell and in fluid communication with the elongate shaft, a collection container operatively coupled to a collection load cell and in fluid communication with the collection drape, an inflow pump configured to pump fluid from the fluid source to the treatment site, and a controller configured to control the inflow pump based on a set of system operating parameters to maintain a desired fluid pressure or a desired fluid flow rate at the treatment site. The controller can be in electronic communication with the supply load cell and the collection load cell. The controller can be configured to calculate a fluid deficit using a rotational speed of the inflow pump along with a difference between a weight change of the fluid source and a weight change of the collection container.

[0016] Additionally or alternatively to any of the examples disclosed herein, the controller can be configured to calculate the fluid deficit only when the distal end of the elongate shaft is positioned within the patient.

[0017] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to automatically suspend the fluid deficit calculation when the distal end of the elongate shaft is removed from the patient.

[0018] Additionally or alternatively to any example disclosed herein, the controller can be configured to calculate a first fluid deficit value using the fluid flow rate and a second fluid deficit value using the difference between the weight change of the fluid source and the weight change of the collection container, and the displayed deficit value can be based on a combination of the first fluid deficit value and the second fluid deficit value.

[0019] Additionally or alternatively to any of the examples disclosed herein, the flow rate of the fluid is determined using the rotational speed of the inlet pump.

[0020] Additionally or alternatively to any of the examples disclosed herein, the fluid flow rate is determined using data from a flow sensor positioned between the fluid source and the treatment site.

[0021] Additionally or alternatively to any example disclosed herein, the controller can be configured to display the displayed deficit value if the difference between the first fluid deficit value and the second fluid deficit value is within a predetermined range. The controller can be configured to display a notification if the difference between the first fluid deficit value and the second fluid deficit value is outside the predetermined range.

[0022] In a third example, in addition to or instead of any of the examples disclosed herein, an automated fluid management system can include a medical device including an elongate shaft configured to access a treatment site within a patient, one or more sensors proximal to a distal end of the elongate shaft, and a handle coupled to a proximal end of the elongate shaft. The automated fluid management system can also include a fluid management system including a first fluid source in fluid communication with the elongate shaft, a second fluid source, a collection container in fluid communication with the elongate shaft, an inflow pump configured to pump fluid from the first fluid source to the treatment site, and a controller configured to set a total fluid deficit to zero after priming the fluid management system. The controller can be configured to automatically initiate calculating a first fluid deficit associated with the first fluid source when the distal end of the elongate shaft is placed within the patient. The controller can be configured to retain the first fluid deficit when the first fluid source is replaced with a second fluid source in fluid communication with the elongate shaft, and the controller can be configured to thereafter calculate a total fluid deficit by adding the first fluid deficit and a second fluid deficit associated with the second fluid source when the distal end of the elongate shaft is positioned within the patient.

[0023] Additionally or alternatively to any of the examples disclosed herein, the controller can be configured to notify the user when the total fluid deficit reaches a preset fluid deficit limit.

[0024] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to automatically suspend the fluid deficit calculation when the distal end of the elongate shaft is removed from the patient.

[0025] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to automatically resume the fluid deficit calculation when the distal end of the elongate shaft is reinserted into the patient.

[0026] In addition to or in the alternative to any of the examples disclosed herein, the controller can be configured to detect signals from one or more sensors to determine when the distal end of the elongate shaft is positioned within the patient.

[0027] 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 following figures and detailed description more particularly exemplify these embodiments.

[0028] The present invention can be more fully understood from a consideration of the following detailed description in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0029] [Figure 1] 1 is a schematic diagram of selected aspects of a fluid management system; [Figure 2] 2 illustrates selected aspects of the medical devices and workstations of the system of FIG. 1. [Figure 3] 3A-3C illustrate selected aspects of the medical device of FIG. 2. [Figure 4] FIG. 3 is a schematic diagram of the medical device of FIG. 2 in situ. [Figure 5] 2 is a partial perspective view of selected aspects of the heater assembly and cassette of the system of FIG. 1. FIG. [Figure 6] FIG. 3 is a schematic block diagram of the fluid management system and medical device of FIGS. 1 and 2. [Figure 7] FIG. 1 illustrates an exemplary display screen.

[0030] While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail below. It is to be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments illustrated. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0031] 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. These detailed descriptions and drawings are illustrative and are not intended to limit the claimed invention. 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. These detailed descriptions and drawings specifically set forth exemplary embodiments of the claimed invention. However, for purposes of clarity and ease of understanding, not all features and / or elements are shown in each drawing, but it can be understood that these features and / or elements are present, unless otherwise specified.

[0032] For the terms defined below, these definitions shall be applied, unless a different definition is provided in the claims or elsewhere in this specification.

[0033] As used herein, all numerical values ​​are assumed to be modified by the term "about," whether specified 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.

[0034] 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).

[0035] 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 explicitly disclosed.

[0036] As used in this specification and claims, "a," "an," and "the" include singular and plural referents unless the context clearly dictates otherwise. As used in this specification and claims, the term "or" is generally used in its sense including "and / or" unless the context clearly dictates otherwise. For ease of understanding, certain features of the present disclosure may be described in the singular; however, it should be noted that these features may be plural or repeated within embodiments of the present disclosure. Each instance of these features may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For purposes of simplicity and clarity, not every inventive element of the present disclosure is shown in each figure and discussed in detail below. However, it will be understood that the following discussion may apply equally to any and / or all of these elements, unless expressly stated to the contrary, when more than one element is present. Additionally, for purposes of clarity, not every instance of some elements or features may be shown in each figure.

[0037] Relative terms such as "proximal," "distal," "advancing," "retracting," 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 "retracting" indicating or meaning closer to or toward a user, and "distal" and "advancing" indicating or meaning farther from or away from a user. In some instances, the terms "proximal" and "distal" may be assigned arbitrarily in an attempt to facilitate understanding of the present disclosure, although such instances will be readily apparent to one of ordinary skill 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.

[0038] The term "limit" may be understood to mean the largest measurement of a described or illustrated dimension unless such limit or dimension is preceded by or designated as "minimum," which may be understood to mean the smallest measurement of the dimension described or illustrated. For example, an "outer limit" may be understood to mean the outer dimension, a "radial limit" may be understood to mean the radial dimension, a "longitudinal limit" may be understood to mean the longitudinal dimension, etc. Each instance of "limit" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be apparent to one of ordinary skill in the art from the particular context of use. Generally, a "limit" may be considered the largest possible dimension measured according to the intended use, whereas a "minimum limit" may be considered the smallest possible dimension measured according to the intended use. In some cases, a "limit" may generally be measured orthogonally in a plane and / or cross-section, but may be measured differently, for example, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as apparent from the particular circumstances.

[0039] The terms "unitary" and "unitary" shall generally mean one or more elements made from or composed of a single structure or base unit / element. Unitary and / or unitary elements exclude structures and / or features made by assembling or otherwise joining together multiple individual elements.

[0040] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described with respect to an embodiment, it is considered within the recognition of one of ordinary skill in the art to generate those particular features, structures, or characteristics with respect to other embodiments, unless expressly stated to the contrary. That is, as will be understood by one of ordinary skill in the art, the various individual elements described below, even if not specified in a specific combination, are still considered to be combinable or configurable with each other to form other or additional embodiments or to complement and / or extend the described embodiments.

[0041] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout this description 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, modifications and departures from previously used numerical nomenclature may be made for purposes of brevity and clarity. That is, a feature designated 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.

[0042] 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 (TURP), etc.), gynecological endoscopic procedures, and other endoscopic procedures can regulate intraluminal pressure using pressure and / or temperature data from an endoscopic device, such as, but not limited to, a LithoVue® scope device, or other endoscopic device. Direct regulation of intraluminal pressure during a medical procedure can enable the fluid management system to safely drive system pressures up to 600 mmHg to ensure no loss of flow during the procedure when inserting tools into the working channel of an endoscopic device. Fluid loss can be a concern for physicians, for example, during procedures that are prolonged and / or use large volumes of fluid. Excessive fluid absorption by the patient can lead to serious complications, such as edema / water intoxication and / or septic conditions, for example, during BPH / TURP in cases of high pressure and / or large volume. Acceptable fluid loss (e.g., fluid deficit) can be difficult to determine because it can vary from patient to patient and procedure to procedure. In addition, tracking the amount of fluid infused can be difficult because many fluid sources (e.g., saline bags, glycine, etc.) may be used during a procedure. Calculating fluid deficit can also be difficult because the calculation relies on a waste collection system, meaning that fluid lost outside the collection system (e.g., on the floor) may escape inclusion in the calculation. As a result, in some procedures, the fluid deficit may be estimated and inaccurate. Systems and methods for automating and / or improving the accuracy of fluid deficit calculation and / or monitoring are desirable.

[0043] 1 is a schematic diagram of a fluid management system 10 that can be used in endoscopic procedures, such as fURS procedures. The fluid management system 10 can be coupled to a medical device 20 that allows fluid flow therethrough and includes a pressure sensor. An exemplary medical device 20 can be a LithoVue® scope device or other endoscope. In an exemplary embodiment, 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 to the fluid management system 10.

[0044] Briefly, the fluid management system 10 may include an inflow pump 50 configured to pump and / or transport fluid from a fluid source 34 (e.g., a fluid bag, etc.) to the medical device 20 and / or treatment site. In some cases, the fluid may pass through a fluid warming system 60 before entering the medical device 20. Fluid flow rate, fluid pressure, fluid temperature, and 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, as described in more detail herein, the controller 48 may receive data from the medical device 20, such as, but not limited to, pressure data and temperature data. The controller 48 may then use the data received from the medical device 20 to control the operating parameters of the inflow pump 50 and / or the fluid warming 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 a target fluid pressure. In some embodiments, the controller 48 can be configured to control the inflow pump 50 based on a set of system operating parameters to maintain a desired fluid pressure or a desired fluid flow rate at the treatment site.

[0045] The fluid management system 10 also includes a fluid management unit. An exemplary fluid management unit can include one or more fluid container supports, e.g., fluid source hangers 32, each supporting one or more fluid sources 34 (e.g., one or more fluid bags). In some embodiments, a remote sensor and / or supply load cell 94 associated with and / or operatively coupled to each fluid source hanger 32 and / or fluid container support can be used to detect the placement and / or weight of the fluid sources 34 (e.g., fluid bags). The controller 48 can be in electronic communication with the supply load cell 94. The fluid source hangers 32 can accept fluid sources 34 of various sizes, such as, for example, 1 liter (L) to 5 L of fluid sources (e.g., fluid bags). It will be understood that any number of fluid sources 34 can be used. Furthermore, any size of fluid source 34 can be used depending on the procedure. In some embodiments, the fluid management unit can be mounted on a rolling stand, which can include a support 36 and / or a base 38. The base 38 may include a number of wheels to facilitate easy movement of the fluid management unit during use. However, it will be understood that the fluid source 34 may be suspended from the ceiling or other location depending on clinical preference. The fluid source hanger 32 may extend from the support 36 and / or the controller 48 and may include one or more hooks from which one or more fluid sources 34 may be suspended. In some embodiments, the fluid used in the fluid management unit may be 0.9% saline. However, it will be understood that a variety of other fluids of varying viscosities may be used depending on the procedure.

[0046] In some embodiments, the fluid management unit includes a collection container 26 in fluid communication with the vacuum pump 24 and 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 receptacles 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 positioned adjacent to and / or near the collection container 26, as shown in FIG. 1 . In some embodiments, the vacuum pump 24 can be positioned within the fluid management system 10. Other configurations are also contemplated. In some embodiments, the collection container 26 can be operatively coupled to a collection load cell 25 to detect the position and / or weight of the collection container 26. In embodiments having multiple containers, canisters, and / or other receptacles, each container, canister, and / or other receptacle may be operatively coupled to a corresponding collection load cell 25. The controller 48 may be in electronic communication with the collection load cell 25.

[0047] 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 screen 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 screen 44. The touch screen interface 42 allows a user to input / adjust various functions of the fluid management system 10, such as flow rate, pressure, or temperature. The user may include parameters and alarms (such as, but not limited to, maximum pressure alarms), displayed information, and procedure modes. The touch screen interface 42 allows a user to add, switch, and / or discontinue use of various modular systems within the fluid management system 10. The touch screen interface 42 may be used to switch 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.

[0048] 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 screen 44 can be configured to show icons for the modular systems and devices included within the fluid management system 10. Additionally, the display screen 44 can include a flow rate display. The flow rate display 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 provide visual and / or audible alerts when parameters (e.g., flow rate, temperature, etc.) exceed or fall below predetermined thresholds and / or ranges. The touch screen interface 42 can be configured to display the amount of fluid remaining in the fluid source 34 and / or any other information the user determines is advantageous during the procedure. In some embodiments, the fluid management system 10 can further 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, the flow rate can be manually controlled using an optional foot pedal 46. Some exemplary display screens 44 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 hereby incorporated by reference.

[0049] The touch screen interface 42 can be operatively connected to or part of a controller 48, which can be a 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 deficit 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, computing, and display. The controller 48 also tracks and stores 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 be connected to a local area network, for example. 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 screen 44.

[0050] The fluid management system 10 may be user-selectable between different modes based on the procedure, patient characteristics, etc. For example, various modes may include, but are not limited to, an fURS mode, a BPH mode, a hysteroscopy mode, a cystoscopy mode, etc. Once a mode is selected by the user, mode parameters such as fluid flow rate, fluid pressure, fluid deficit, and temperature may be provided to the user via a display screen. Exemplary parameters for a particular mode may be predetermined and loaded onto the controller 48, for example, using software. Thus, when a user selects a procedure from the initial display (e.g., FIG. 7 ) on the touch screen interface display screen 44, these known parameters may be loaded from the controller 48 into various components of the fluid management system 10, such as the inflow pump 50, the fluid warming system 60, and the fluid deficit management system. The fluid management system 10 may be user-selectable between an automatic mode and a manual mode. For example, during certain procedures, a user may desire to manually adjust fluid flow rate, fluid pressure, and / or other parameters. If the user selects manual mode operation, for example, on the touch screen interface 42, the user can adjust fluid flow rate or fluid pressure through an optional foot pedal 46 or other manual interface, such as a fluid control interface. If the user selects automatic mode, the user can be prompted through the touch screen interface 42 to select or input which medical device 20 is being used so that the controller 48 can determine whether data obtained from the medical device 20 can be used to facilitate control of the fluid management system 10. As described in more detail herein, the fluid management system 10 can be configured to verify that the selected medical device 20 is actually being used before using the collected data.

[0051] The controller 48 can be configured to include vision / image recognition software capable of detecting visual noise based on changes in brightness (e.g., a light monitor), contrast, or color pixilation. If the image provided to the controller 48 is determined to be not sufficiently clear or sharp, the fluid management system 10 can increase the fluid flow rate or pressure to flush debris from the treatment site and sharpen / clarify the image. The fluid flow rate or pressure can be increased for a temporary period (a predetermined duration) or until the field of view is deemed sufficiently clear. This temporary increase ensures that the time for increasing the fluid flow rate or pressure is limited to ensure that intraluminal pressure does not exceed safety limits. For example, the fluid management system 10 can recognize a red hue in the irrigation fluid (indicative of blood) and signal the inflow pump 50 to increase the fluid flow rate or pressure until the blood is cleared from the field of view. Alternatively, the controller 48 can provide a visual warning on the display screen 44 or an audible warning to the physician or nurse that cloudy vision has been detected, and the user can then manually adjust the irrigation fluid flow rate. As another example, in instances where a significant amount of debris is present, light reflected from the debris may substantially increase the brightness of the image. In this regard, the controller 48 detects this excessive brightness and signals the inflow pump 50 to increase the fluid flow rate or fluid pressure to flush and / or remove the debris. When the reflected light decreases as the debris is washed away from the field of view of the imaging system, the inflow pump 50 is controlled by the controller 48 to decrease the fluid flow rate or fluid pressure. In some cases, the physician may generate a baseline visibility level at which they would like to initiate fluid flow to clarify the field of view and input these parameters into the fluid management system 10 via the touch screen interface 42 prior to the procedure. Once the baseline is generated, the fluid management system 10 can monitor the visual feed for changes in the image and automatically adjust the fluid flow rate as needed.

[0052] To regulate fluid flow rate or fluid pressure through the fluid management system 10, the fluid management unit can include one or more pressurizing devices, such as an inflow pump 50. In some embodiments, the inflow pump 50 can be a peristaltic pump. In some embodiments, the inflow pump 50 can include multiple pumps or more than one pump. The inflow pump 50 can be electrically powered and can receive power from a line 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 can be operated at any desired speed sufficient to deliver fluid at a target pressure, such as from 5 mmHg to 50 mmHg, and / or at a target fluid flow rate or target fluid pressure. As noted herein, the inflow pump 50 can be automatically adjusted based on, for example, pressure and / or temperature readings within the treatment site and / or visual feedback from the medical device 20. The inflow pump 50 can be manually adjusted, for example, through an optional foot pedal 46, a touch screen interface 42, or a separate fluid controller. Although not explicitly shown, the fluid controller may be a separate user interface that includes buttons that allow a user to turn the inflow pump 50 on or off. Alternatively, the fluid controller may be incorporated into the main processing device and may accept input through the touch screen interface 42. It will be appreciated that any number of pumps may be used. In some embodiments, the fluid management system 10 may include multiple pumps with various flow capabilities. In some embodiments, a flow meter may be located before and / or after the inflow pump 50.

[0053] The fluid flow rate or pressure of the fluid at any given time can be displayed on the display screen 44 to provide operating room (OR) visibility to any changes. If OR personnel notice a change in the fluid flow rate or pressure that is either too high or too low, the user can manually adjust the fluid flow rate or pressure to return to the preferred level. This may occur, for example, when a physician inserts or removes a tool from the working channel of the medical device 20. The fluid management system 10 can monitor and automatically adjust the fluid flow rate or pressure based on preset parameters, as discussed herein. This feature can be advantageous when fluid flow is supplied manually, for example, when an assistant injects irrigation fluid via a syringe.

[0054] In some embodiments, the fluid management system 10 can include vision software or image recognition analysis software. For example, the fluid management system 10 can detect whether a tool has been inserted and whether the tool is being used via a camera 70 (see, e.g., FIGS. 2 and 3 ) located on the medical device 20 within the body. The tool can have an identifiable marker that can be identified by the vision software to inform the fluid management system 10, for example, what type of tool is being used. The fluid management system 10 can then automatically adjust the fluid flow rate or fluid pressure based on the tool identified by the vision software. Thus, when the tool is retracted from the working channel, the fluid management system 10 can automatically reduce the fluid flow rate or fluid pressure.

[0055] Additionally or alternatively, the fluid management system 10 can automatically adjust the fluid flow rate or pressure based on the intraluminal temperature and / or pressure detected within the treatment site. The intraluminal temperature and / or pressure can be measured in situ using a temperature sensor 72 and / or a pressure sensor 74 mounted on the medical device 20 in conjunction with the fluid management system 10. The fluid management system 10 can include pressure monitoring software that a user can configure to automatically start, stop, and / or adjust the speed of the inflow pump 50 to maintain the pressure of the fluid delivered to the treatment site within a target pressure and / or predetermined pressure range. For example, the pressure sensor 74 can detect pressure within the treatment site (e.g., kidney or uterus) and automatically modify the fluid flow rate or pressure within the fluid management system 10 based on the monitored intraluminal (e.g., intrarenal or intrauterine) pressure. If the intraluminal pressure is too high, the fluid management system 10 can reduce the fluid flow rate or pressure, and if the intraluminal pressure is too low, the fluid management system 10 can increase the fluid flow rate or pressure. In an exemplary temperature control mode, the fluid management system 10 can include temperature monitoring software that can control (e.g., start, stop, and adjust temperature) the fluid warming system 60 to maintain the temperature of the fluid delivered to the treatment site approximately at a target temperature and / or within a predetermined temperature range. For example, temperature can be monitored in vivo or ex vivo, and fluid flow can be modified based on the temperature feedback provided. In the illustrated embodiment, the fluid management system 10 can compare the sensed temperature and / or pressure within the treatment site to known values ​​and provide a warning when the parameters are outside of a predetermined safe range. The warning can be a visual or audible warning.

[0056] In some embodiments, the fluid management system 10 can monitor the movement of a target structure or object, such as a kidney stone. The fluid management system 10 can calculate the rate of movement based on the original and new positions of the target structure or object. If the movement exceeds a predetermined threshold, the user can be alerted to manually adjust the fluid flow rate or pressure of the fluid management system 10. As described herein, the fluid flow rate or pressure can be manually adjusted through an optional foot pedal 46, touch screen interface 42, and / or pump interface. In some embodiments, when in automatic mode, the fluid management system 10 will automatically adjust the fluid flow rate or pressure as needed. This feature can be highly advantageous in controlling retropulsion of the target structure or object during procedures such as lithotripsy.

[0057] 2-4 illustrate aspects of a medical device 20 that can be used in conjunction with the fluid management system 10. In the illustrated embodiment, the medical device 20 can be a ureteroscope, such as a LithoVue® scope. However, other medical devices, such as another endoscope, can be used in addition to or instead of a ureteroscope. The medical device 20 can be configured to deliver fluid from the fluid management system 10 to a treatment site through an elongated shaft 76 configured to access the treatment site within the patient. In some embodiments, the inflow pump 50 can be in fluid communication with the elongated shaft 76. The elongated shaft 76 can include one or more working lumens for receiving fluid flow or other medical devices therethrough. As shown in FIG. 4, which is a schematic illustration of the medical device 20 positioned in a patient's body in fluid communication with the fluid management system 10, the medical device 20 is connected to the fluid management system 10 through one or more supply lines 78 (e.g., tubing).

[0058] 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.

[0059] One or more supply lines 78 from the fluid management system 10 to the medical device 20 can be formed of a material that helps dampen the peristaltic movement achieved by the inflow pump 50. Returning now to 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 pressure sensor 74 at the distal tip of the elongate shaft 76 for measuring intraluminal pressure within the treatment site. The medical device 20 can further include, for example, 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 an exemplary embodiment, the distal end 80 of the medical device 20 can further include at least one camera 70 to provide a visual feed to the user on a display screen of the 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, a user can optionally switch between these cameras 70 through the touch screen interface 42 and / or touch panel computer 83. Although not specified, the elongate shaft 76 can include one or more working lumens for receiving fluids and / or other medical devices.

[0060] The medical device 20 includes a handle 82 coupled to the proximal end of the elongate shaft 76. The handle 82 can have a fluid flow on / off switch 84 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 86 that perform various other functions. For example, in some embodiments, the handle 82 can include a button for controlling the temperature of the fluid. In some embodiments, the handle 82 can include a laser that allows a user to emit laser energy. In an exemplary embodiment, the laser can be a Lumenis or StarMed Tech laser. A laser fiber can be connected to the laser system and inserted through the working channel of the ureteroscope. The user can emit the laser so that energy emerges from the tip of the laser fiber and strikes and destroys debris / stones. In an exemplary embodiment that includes a laser button on the handle 82, a line of communication (e.g., wired or wireless) between the laser system and the handle 82 is maintained. While this exemplary embodiment describes a ureteroscope, it will be understood that the features detailed above may be integrated directly into a cystoscope, endoscope, hysteroscope, or virtually any device with imaging capabilities. In some embodiments, medical device 20 may further include a drainage port 88 that may 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 SYSTEM," assigned to the assignee of the present invention, the disclosure of which is hereby incorporated by reference.

[0061] Returning briefly to FIG. 1, the controller 48 may be configured to calculate a fluid deficit representing fluid lost during the procedure when the distal end 80 of the elongate shaft 76 is positioned within the patient, a fluid deficit absorbed by the patient, and / or an otherwise unknown fluid deficit.

[0062] Prior to beginning a procedure, the fluid management system 10 may need to be primed or filled to remove any air from the system. Priming the fluid management system 10 may result in a loss of fluid. In some embodiments, the controller 48 may be configured to automatically reset the fluid deficit to zero after priming the fluid management system 10. In some embodiments, the controller 48 may be configured to automatically initiate a fluid deficit calculation when a signal from one or more sensors indicates that the distal end 80 of the elongate shaft 76 has been inserted into the patient. In some embodiments, the controller 48 may be configured to automatically suspend a fluid deficit calculation when the distal end 80 of the elongate shaft 76 is removed from the patient. Additional details regarding systems and methods for detecting when the distal end 80 of the elongate shaft 76 of the medical device 20 is positioned within the patient are discussed below. In some embodiments, the controller 48 may be configured to automatically resume a fluid deficit calculation when a signal from one or more sensors indicates that the distal end 80 of the elongate shaft 76 has been reinserted into the patient. In some embodiments, the controller 48 can be configured to calculate the fluid deficit only when the distal end 80 of the elongate shaft 76 is positioned within the patient.

[0063] In an alternative embodiment, the fluid deficit calculation can begin after initial system setup (e.g., before priming). After setup, the controller 48 can enter a “priming mode.” The controller 48 can be configured to monitor the fluid used during priming of the system (e.g., “priming mode”). The fluid used during priming can be determined using pump rotational speed, flow sensor data, weight change in the fluid source 34, or other suitable means. After priming the system, the controller 48 can enter an “operating mode.” To determine the true fluid deficit, the fluid used during priming of the system can be excluded from the fluid deficit calculation and / or subtracted from the calculated fluid deficit. For example, the supply line 78 and / or heater cassette 64 can define and / or contain a known fluid volume. The controller 48 can be configured to exclude this known fluid volume in the supply line 78 and / or heater cassette 64 from the fluid deficit calculation.

[0064] Additionally, in some embodiments, the fluid deficit calculation can continue uninterrupted as the fluid source 34 is replenished. For example, the procedure continues if the fluid source 34 is replaced or replenished during the procedure. Thus, the fluid deficit being calculated by the controller 48 can also continue to maintain a total fluid deficit throughout the procedure. Accordingly, in some embodiments, the fluid management system 10 can include a first fluid source 34 in fluid communication with the elongate shaft 76 and a second fluid source 34. The controller 48 can be configured to set the total fluid deficit to zero after priming the fluid management system 10. In use, the controller 48 can be configured to automatically begin calculating a first fluid deficit for the first fluid source 34 when the distal end 80 of the elongate shaft 76 is positioned within the patient. If the first fluid source 34 is depleted or exhausted during the procedure, the first fluid source 34 can be replaced, thereby replenished, and / or replenished with the second fluid source 34. The controller 48 can be configured to retain the first fluid deficit when the first fluid source 34 is replaced with a second fluid source 34 in fluid communication with the elongate shaft 76, and can then be configured to calculate the total fluid deficit by adding the first fluid deficit to a second fluid deficit associated with the second fluid source 34 when the distal end 80 of the elongate shaft 76 is positioned within the patient.

[0065] In some embodiments, the controller 48 can be configured to notify the user when the total fluid deficit reaches a preset fluid deficit limit. In some embodiments, the controller 48 can be configured to stop the inflow pump 50 and / or the vacuum pump 24 when the total fluid deficit reaches a preset fluid deficit limit.

[0066] In some embodiments, the controller 48 can be configured to notify the user when the total amount of fluid infused reaches a preset fluid infusion limit. In some embodiments, the controller 48 can be configured to stop the inflow pump 50 and / or the vacuum pump 24 when the total amount of fluid infused reaches a preset fluid infusion limit.

[0067] In some embodiments, the controller 48 can be configured to monitor the amount of fluid in the fluid supply 34 through weight, for example, using a supply load cell 94, a scale, or other suitable means. The supply load cell 94 can be used by the controller 48 to determine the weight of the fluid supply 34 attached to the fluid supply hanger 32 and compare the initial amount of fluid in the fluid supply 34 to the current amount of fluid remaining in the fluid supply 34. The reading of the supply load cell 94 can be shown to the user on the display screen 44. As the procedure progresses, the reading of the supply load cell 94 can be updated in real time to alert the physician of how much fluid is left in the fluid supply 34, which can then be used to determine how much fluid has been infused into the patient. In some embodiments, the fluid management system 10 and / or the controller 48 can provide the amount of time remaining before a new fluid supply 34 is needed based on the weight of the fluid source 34 and the rate at which the fluid source 34 is emptying (e.g., fluid flow rate). In some embodiments, the amount of fluid remaining in the fluid source 34 can be indicated. For example, an audible signal may indicate a warning on the display screen 44 when 10% fluid remains in the fluid supply 34. In some embodiments, the supply load cell 94 may be connected to the display screen 44 through a wireless (e.g., WiFi) signal. In some embodiments, the supply load cell 94 may be connected to the display screen 44 through a hardwire connection.

[0068] Similarly, the controller 48 can be configured to monitor the amount of fluid in the collection container 26 through weight, for example, using the collection load cell 25, a scale, or other suitable means. The collection load cell 25 can be used by the controller 48 to determine the weight of the collection container 26 and compare the initial amount of fluid in the collection container 26 to the current amount of fluid in the collection container 26. The reading of the collection load cell 25 can be shown to the user on the display screen 44. As the procedure progresses, the reading of the collection load cell 25 can be updated in real time to alert the physician to how much fluid is in the collection container 26, which can then be used to determine how much fluid has been collected from the patient and / or collection drape 28. In some embodiments, the fluid management system 10 and / or controller 48 can provide an amount of time remaining before a new collection container 26 is needed based on the weight of the collection container 26 and the rate at which the fluid source 34 is emptying (e.g., fluid flow rate). In some embodiments, the amount of fluid in the collection container 26 can be indicated. For example, an audible signal may indicate a warning on the display screen 44 when only 10% of the initial empty volume remains in the collection container 26. In some embodiments, the collection load cell 25 may be connected to the display screen 44 through a wireless (e.g., WiFi) signal. In some embodiments, the collection load cell 25 may be connected to the display screen 44 through a hardwire connection.

[0069] In some embodiments, the fluid deficit calculation can continue uninterrupted as the collection container 26 is emptied or replaced. For example, the procedure continues as the collection container 26 is emptied or replaced during a procedure. Thus, the fluid deficit being calculated by the controller 48 can also continue to maintain a total fluid deficit throughout the procedure. If the collection container 26 becomes full during a procedure, the collection container 26 can be emptied and placed back in use or replaced with an empty collection container. In some embodiments, the controller 48 can be configured to hold the amount of fluid in the collection container 26 and then calculate the total fluid deficit by adding the amount of fluid in the collection container 26 to a second amount of fluid associated with the empty or replacement collection container when the distal end 80 of the elongate shaft 76 is positioned within the patient.

[0070] In some embodiments, the controller 48 can be configured to calculate a fluid deficit using the rotational speed of the inflow pump 50 along with the difference between the weight change of the fluid source 34 and the weight change of the collection container 26. For example, the rotational speed of the inflow pump 50 can define a known fluid flow rate (e.g., an expected amount of fluid to be infused into the patient and / or treatment site), and the difference between the weight of fluid removed from the fluid source 34 and the weight of fluid added to the collection container 26 can correspond to a fluid deficit (lost fluid). In some embodiments, the controller 48 can be configured to correlate the weight change of the fluid source 34 with the rotational speed of the inflow pump 50 and / or data from a flow sensor to determine whether fluid is being lost at the fluid source 34 or elsewhere upstream of the treatment site and / or outside the patient's body (e.g., a fluid bag has ruptured). In some embodiments, the controller 48 can be configured to calculate a first fluid deficit value using the rotational speed of the inflow pump 50 and a second fluid deficit value using the difference between the weight change of the fluid source 34 and the weight change of the collection container 26. The displayed deficit value (e.g., on display screen 44) can be based on a combination of the first fluid deficit value and the second fluid deficit value. For example, the first fluid deficit value can be compared and / or correlated with the second fluid deficit value. In some embodiments, controller 48 can be configured to display the displayed deficit value if the difference between the first fluid deficit value and the second fluid deficit value is within a predetermined range. In some embodiments, controller 48 can be configured to display a notification if the difference between the first fluid deficit value and the second fluid deficit value is outside of a predetermined range.

[0071] In some embodiments, the fluid management system 10 can include a pressure sensor connected in series between the fluid source 34 and the medical device 20, such that the pressure in the supply line 78 is determined based on the height of the fluid source 34. As the fluid source 34 empties, the amount of head pressure decreases. If this pressure falls below a threshold set by the user, a warning can be displayed on the display screen 44 and an audible signal can be sent. In another exemplary embodiment, the controller 48 can be set to a specific fluid flow rate or pressure based on the amount of time that has elapsed. A physician can input an initial fluid volume of the fluid source 34 into the fluid management system 10 and / or controller 48, which then calculates the amount of fluid already used and how much is remaining based on the known fluid flow rate or known fluid pressure and the amount of time the fluid management system 10 has been in use. In some embodiments, a flow sensor can be connected in series between the fluid source 34 and the medical device 20. The flow sensor can be operatively connected to the controller 48, and data from the flow sensor can be used by the controller 48 to modify selected system parameters and / or can be used in fluid deficit calculations.

[0072] The fluid management system 10 can utilize supply lines 78 to connect to various components. In some embodiments, the supply lines 78 can be formed from small diameter tubing, having a diameter less than or equal to 1 / 16 inch (1.5875 millimeters). However, it will be understood that the tubing size can 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 irrigation within the body and / or treatment site.

[0073] In some embodiments, the fluid management system 10 can include a fluid warming system 60 for heating fluid to be delivered to a patient, as shown in FIG. 5 . The fluid warming system 60 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 integral piece or multiple pieces permanently bonded 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. The fluid inlet port 61 and the fluid outlet port 63 can each 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 supply 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 connection being through a supply line 78.

[0074] In some embodiments, the heater cassette 64 can include an internal flow path along a channel that allows fluid to flow from the fluid inlet port 61 to the fluid outlet port 63. The heater cassette 64 can include one or more flow paths. In some embodiments, the channel can pass through a susceptor 66, which can allow 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 warming system configurations and methods can be used as desired. For example, the heater 62 can include one or more heat sources within the supply line 78, such as a platen system or series coil using electrical energy. The heating can be specifically designed and adapted to the flow rate required for a particular application of the fluid management system 10. Some exemplary fluid warming systems 60 are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," assigned to the assignee of the present invention, the entire disclosure of which is hereby incorporated by reference.

[0075] Although not explicitly shown, the fluid warming system 60 may include a heater user interface that is separate from the touch screen interface 42. The heater user interface may simply be a display screen that provides a digital display of the internal temperature of the heater 62. In another embodiment, this user interface may 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 may include 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 may be communicated directly to the display screen 44, such that a heater user interface is not required.

[0076] Fluid warming system 60 may include one or more sensors configured to monitor the fluid flowing therethrough. For example, a temperature sensor 65 may be mounted within fluid warming system 60 to detect the temperature of the fluid flowing through heater cassette 64. Temperature sensor 65 may be positioned at or near fluid inlet port 61 and / or fluid outlet port 63. In some embodiments, temperature sensor 65 may be mounted to detect the temperature of the fluid flowing through heater cassette 64 before the fluid enters susceptor 66 and after the fluid exits susceptor 66. In some embodiments, an additional sensor may be positioned at an intermediate portion of susceptor 66 to detect the progression of the temperature rise of the fluid within heater cassette 64. Temperature sensor 65 may transmit any information remotely to display screen 44 or may transmit information to the heater user interface and / or its display screen, if so provided. 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 communicate desired information to the display screen 44. Alternatively or additionally, the temperature sensor 65 may be hardwired to and / or with the controller 48.

[0077] The heater 62 may further include a pressure sensor 67 and / or an air bubble sensor 69. The heater cassette 64 may include a corresponding pressure sensor interface 71 and an air bubble sensor interface 73 that enable the pressure sensor 67 and the 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 pressure sensor 67 and / or the air bubble sensor 69 may transmit any information remotely to the display screen 44 or may transmit information to the heater user interface and / or its display screen, if so provided. In another embodiment, the pressure sensor 67 and / or the air bubble sensor 69 may be hardwired to the heater user interface (if provided), in which case the heater user interface may remotely communicate the desired information to the display screen 44. Alternatively or additionally, the pressure sensor 67 and / or the air bubble sensor 69 may be hardwired to and / or with the controller 48.

[0078] 6 is a schematic block diagram illustrating the fluid management system 10 and the medical device 20. As described herein, there can be two primary interfaces between the fluid management system 10 and the medical device 20, including one or more mechanical connections (e.g., supply lines 78) that fluidly couple the medical device 20 to the heater cassette 64, and one or more wired or wireless communication connections 91 (e.g., Ethernet cord, WiFi, etc.) that couple a workstation 81 to the controller 48 of the fluid management system 10. The workstation 81 can communicate pressure data (e.g., obtained using the medical device 20) to the controller 48 of the fluid management system 10. The controller 48 of the fluid management system 10 can then use the pressure data from the medical device 20 to adjust the fluid flow rate or pressure when a user-specified value or a predetermined pressure limit is reached.

[0079] However, for example, during a typical stone treatment procedure, the fluid management system 10 may be connected to multiple endoscopes or other medical devices. Similarly, in a procedure in which both a medical device 20 having a pressure sensor 74 and the fluid management system 10 are used, the controller 48 and the workstation 81 may be connected during preparation for the OR and may remain connected throughout the procedure. This may mean that if a medical device 20 is connected to the workstation 81, the workstation 81 may communicate pressure data to the controller 48 of the fluid management system 10, regardless of whether the medical device 20 is being used. Thus, the controller 48 of the fluid management system 10 may be configured to determine when it is safe to use pressure data from the medical device 20 to adjust intraluminal pressure. In some embodiments, this may be done by prompting the user to select the type of medical device 20 being used on the touch screen interface 42. If the physician selects a device other than the medical device 20, the controller 48 of the fluid management system 10 may ignore the pressure data being transmitted from the medical device 20.

[0080] However, a physician may mistakenly select a medical device 20 when the physician is not actually using the medical device 20 or when the physician may have forgotten to inform the fluid management system 10 that the medical device 20 is no longer in use and a different endoscope or medical device is currently being used. If the fluid management system 10 is unable to detect that a new endoscope or medical device is being used, it may mistakenly use pressure data transmitted from the out-of-use medical device 20 (and thus inaccurate pressure data regarding intraluminal pressure). As a result, the pressure limit control of the fluid management system 10 may be essentially bypassed, allowing the fluid management system 10 to drive or deliver potentially dangerous pressures. To prevent such danger from occurring, the fluid management system 10 may need to determine, via the workstation 81, when it is safe to use pressure data transmitted from the medical device 20. Therefore, it may be desirable to detect whether a sensor-enabled medical device 20 is connected to the fluid management system 10 when the only connection between the medical device 20 and the fluid management system 10 may be a physical connection using, for example, a standard Luer connector.

[0081] When the medical device 20 is in use with the fluid management system 10, the medical device 20 may be exposed to several inherent sources of pulsatile pressure that can be measured by the pressure sensor 74 at its distal tip. These pulsatile sources may be inherent to either the fluid management system 10 or the patient. If one or more pulsatile sources can be distinguished, the fluid management system 10 can make a determination that the medical device 20 is in use and therefore it is safe to limit the fluid pressure based on pressure data from the medical device 20.

[0082] One source of pulsatile pressure may occur within the fluid management system 10. For example, the inflow pump 50 may generate a unique fingerprint in the pulsatile flow that can be measured using a pressure sensor, such as the pressure sensor 74 of the medical device 20. The pulsatile pressure may be a function of the pump head rollers and revolutions per minute (RPM) of the pump head. When the medical device 20 is connected to the fluid management system 10, this fingerprint may be measured by the medical device 20 and matched to a signature achieved by the inflow pump 50 of the fluid management system 10. If there is a match between the pulsatile pressure measured by the pressure sensor 74 of the medical device 20 and the known signature of the inflow pump 50 of the fluid management system 10, the fluid management system 10 can confirm that the medical device 20 is in use and connected to the fluid management system 10.

[0083] In some embodiments, raw pressure data from the fluid management system 10 can be received from a pressure sensor 67 in the fluid warming system 60. In other embodiments, the raw pressure data can be retrieved from a database of expected pressures according to fluid flow rates. In the illustrated embodiment, this raw pressure data and the pressure data from the medical device 20 are collected at a moderate fluid flow rate of approximately 100 milliliters per minute (mL / min). However, it is understood that the data processing steps described herein can be used for fluid flow rates lower than 100 mL / min and higher than 100 mL / min. To compare the raw pressure data from the fluid management system 10 and the pressure data from the medical device 20, the raw pressure data and the pressure data from the medical device 20 can be filtered using a mathematical average. In some embodiments, the raw pressure data and the pressure data from the medical device 20 can be filtered using a low-pass filter having a filter cutoff frequency. The filter cutoff frequency can be set based on the pump flow rate. The raw pressure data and the pressure data from the medical device 20 can then be normalized. A Fast Fourier Transform (FFT) algorithm can then be performed on the filtered and normalized pressure data to extract the dominant tone achieved by the inflow pump 50. The FFT algorithm can convert the filtered and normalized pressure data from the time domain to the frequency domain. Once the filtered and normalized pressure data is converted to the frequency domain, the dominant tone of the fluid management system 10 (e.g., the frequency with the greatest vibration intensity) and the dominant tone of the medical device 20 can be identified. In some embodiments, the dominant tone of the fluid management system 10 and the dominant tone of the medical device 20 are similar or the same at 2.3 Hertz (Hz). In the illustrated example, the fluid management system 10 can determine whether the dominant tones match. The dominant tones can be considered to match if they are equal, approximately equal, or within a predetermined range of each other.When the dominant tone of the fluid management system 10 matches the dominant tone of the medical device 20, the fluid management system 10 can determine that the medical device 20 is in use, connected to the fluid management system 10, and that the fluid management system 10 can be controlled using pressure data from the medical device 20.

[0084] It is contemplated that data processing may occur in the controller 48, the workstation 81, or a combination thereof. In some embodiments, the raw pressure data and the pressure data from the medical device 20 may all be processed and analyzed by a single processing device. In other embodiments, the raw pressure data and the pressure data from the medical device 20 may be processed by separate processing devices. For example, in some cases, the controller 48 may process (e.g., filter, normalize, and / or FFT) the raw pressure data obtained from the fluid management system 10, while the workstation 81 may process (e.g., filter, normalize, and / or FFT) the pressure data obtained from the medical device 20. In some cases, the processed pressure data from the medical device 20 may be communicated from the workstation 81 to the controller 48 for comparison. In other embodiments, the processed raw pressure data from the fluid management system 10 may be communicated from the controller 48 to the workstation 81 for analysis.

[0085] In some embodiments, at higher fluid flow rates, such as 400 mL / min, the dominant tone of the fluid management system 10 and the dominant tone of the medical device 20 may not be similar or the same. This is merely an example and is not intended to be limiting. In this example, the dominant tone of the fluid management system 10 may be approximately 9.5 Hz, while the dominant tone of the medical device may be approximately 4 Hz. Thus, in this example, the fluid management system 10 may determine that the dominant tones do not match and therefore, pressure data from the medical device 20 should not be used to control the fluid management system 10.

[0086] Another source of pulsatile pressure may be the patient's heartbeat. For example, pulsatile waves synchronized with the heartbeat may be transmitted into the renal pelvis. These pulsatile waves may generate a unique pressure signature of the cardiac rhythm that can be detected by the medical device 20. The fluid management system 10 may be configured to compare characteristics extracted from the pressure signature of the heartbeat with characteristics extracted from pressure data received from the pressure sensor 74 on the medical device 20. The characteristics may be frequency, amplitude, dominant tone, etc. In one example, the fluid management system 10 may compare filtered, normalized, and converted to the frequency domain heartbeat data with pressure data from the medical device 20 that has also been filtered, normalized, and converted to the frequency domain in a manner similar to that just described. It is contemplated that the heartbeat data may be obtained from a medical device other than the fluid management system 10 or other than the medical device 20. If a cardiac rhythm is detected in the pressure data collected by the medical device 20, the fluid management system 10 can determine that the medical device 20 is in use and, therefore, the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. If a cardiac rhythm cannot be detected in the pressure data collected by the medical device 20, the fluid management system 10 can determine that the medical device 20 is not in use and that the pressure data from the medical device 20 should not be used to control the fluid management system 10.

[0087] Another source of pulsatile pressure may be the patient's ureteropelvic activity. For example, contraction and relaxation of the patient's ureter or renal pelvis may generate unique, measurable pressure waves. The cyclical pressure changes from these contractions may be detected using the pressure sensor 74 in the medical device 20. The fluid management system 10 may be configured to compare characteristics extracted from the pressure signature of the ureteropelvic activity with characteristics extracted from pressure data received from the pressure sensor 74 on the medical device 20. The characteristics may be frequency, amplitude, dominant tone, etc. In some cases, the contractions may be detected using sensors other than the medical device 20 or the fluid management system 10 for comparison with the pressure data from the medical device 20. In other embodiments, the fluid management system 10 may be configured to compare expected or preprogrammed contraction patterns with the pressure data from the medical device 20. It is contemplated that the contraction data (if obtained during a medical procedure) may also be filtered, normalized, and converted to the frequency domain before being compared to the pressure data from the medical device 20, which has been filtered, normalized, and converted to the frequency domain in a manner similar to that just described. If ureteropelvic activity is detected in the pressure data from the medical device 20, the fluid management system 10 can determine that the medical device 20 is in use and, therefore, the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. If no ureteropelvic activity can be detected in the pressure data from the medical device 20, the fluid management system 10 can determine that the medical device 20 is not in use and that the pressure data from the medical device 20 should not be used to control the fluid management system 10.

[0088] Yet another source of pulsatile pressure may be the patient's breathing. For example, a patient's normal breathing rhythm may produce slow changes in intrarenal pressure over time. These slow pressure changes may be measured by the pressure sensor 74 on the medical device 20 (when the medical device 20 is in use) and matched to the patient's breathing rhythm. The fluid management system 10 may be configured to compare characteristics extracted from the pressure signature of the breathing rhythm with characteristics extracted from pressure data received from the pressure sensor 74 on the medical device 20. These characteristics may be frequency, amplitude, dominant tone, etc. In an example, the fluid management system 10 may compare filtered, normalized, and converted to the frequency domain respiratory data with pressure data from the medical device 20 that has also been filtered, normalized, and converted to the frequency domain in a manner similar to that just described. It is contemplated that respiratory data may be obtained from a medical device other than the fluid management system 10 or other than the medical device 20. If a respiratory rhythm is detected in the pressure data from the medical device 20, the fluid management system 10 can determine that the medical device 20 is in use and therefore the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. If a respiratory rhythm cannot be detected in the pressure data from the medical device 20, the fluid management system 10 can determine that the medical device 20 is not in use and that the pressure data from the medical device 20 should not be used to control the fluid management system 10.

[0089] In some embodiments, the fluid management system 10 can use the pulsatile pressure to determine whether the medical device 20 is being used within a patient's body. Initially, the controller 48 of the fluid management system 10 can initiate a device verification process. It is contemplated that the controller 48 can be configured to perform the device verification process at predetermined intervals during a procedure (e.g., every minute, every five minutes, etc.). In other embodiments, the controller 48 can be configured to perform the device verification process each time the fluid management system 10 attempts to control fluid flow from the fluid management system 10 using pressure data from the medical device 20. Additionally or alternatively, the device verification process can be initiated manually. For example, a physician can initiate the device verification process using the touch screen interface 42. The fluid management system 10 can then obtain pressure data from the medical device 20. In some cases, the controller 48 can poll the workstation 81 for raw pressure data for a predetermined period of time, although this is not required. In some cases, the controller 48 can instruct the workstation 81 to obtain pressure data from the medical device 20. The pressure data from the medical device 20 may then be filtered, normalized, and converted to the frequency domain. It is contemplated that the pressure data from the medical device 20 may be processed in the controller 48 or workstation 81 as desired.

[0090] The fluid management system 10 can acquire pulsatile pressure data from the fluid management system 10 and / or the patient. Sources of the pulsatile pressure data can include, but are not limited to, pressure pulses generated by the inflow pump 50, the patient's heartbeat, the patient's ureteropelvic activity, the patient's respiratory rhythm, etc. It is contemplated that the fluid management system 10 can be configured to acquire the pulsatile pressure data over the same predetermined time period (e.g., substantially simultaneous with) the pressure data from the medical device 20. However, in some cases, the fluid management system 10 may not be able to acquire new data related to the pulsatile pressure data and may instead reference predetermined baseline or expected data. The pressure data from the fluid management system 10 and / or the patient can be filtered, normalized, and converted to the frequency domain. It is contemplated that the pressure data from the fluid management system 10 and / or the patient can be processed by the controller 48 or workstation 81 as needed.

[0091] The controller 48 or workstation 81 can then compare the frequency domain data of the medical device 20 with the frequency domain data of the pulsating pressure source. Further, the controller 48 or workstation 81 can determine whether the frequency domain data of the medical device 20 and the frequency domain data of the pulsating pressure source match. If the frequency domain data of the medical device 20 and the frequency domain data of the pulsating pressure source match, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10. If the frequency domain data of the medical device 20 and the frequency domain data of the pulsating pressure source do not match, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10.

[0092] Alternatively or additionally, data obtained from the temperature sensor 72 of the medical device 20 can be used to determine whether data from the pressure sensor 74 of the medical device 20 can be used to assist in controlling the fluid management system 10. Initially, the controller 48 can initiate a device verification process. It is contemplated that the controller 48 can be configured to perform the device verification process at predetermined intervals during the procedure (e.g., every minute, every five minutes, etc.). In other embodiments, the controller 48 can be configured to perform the device verification process each time the fluid management system 10 attempts to control fluid flow from the fluid management system 10 using pressure data from the medical device 20. Additionally or alternatively, the device verification process can be initiated manually. For example, a physician can initiate the device verification process using the touch screen interface 42. The fluid management system 10 can then obtain temperature data from the medical device 20. In some cases, the controller 48 can poll the workstation 81 for raw data for a predetermined period of time, although this is not required. In some cases, the controller 48 can instruct the workstation 81 to obtain temperature data from the medical device 20.

[0093] The controller 48 or workstation 81 may then determine whether the temperature measurement from the medical device 20 is higher than room temperature (e.g., higher than approximately 20°C to 23°C). In some cases, the controller 48 or workstation 81 may then determine whether the temperature measurement from the medical device 20 is around body temperature (e.g., approximately 37°C). If the temperature measurement obtained from the temperature sensor 72 on the medical device 20 is higher than 20°C to 23°C (e.g., room temperature) or approximately 37°C (e.g., body temperature), the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10. If the temperature measurement obtained from the temperature sensor 72 on the medical device 20 is between approximately 20°C to 23°C (e.g., room temperature) or lower than approximately 37°C (e.g., body temperature), the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10. In some cases, the fluid management system 10 can be configured to determine that the medical device 20 is in use whenever the temperature measurement obtained by the temperature sensor 72 is greater than room temperature (e.g., greater than approximately 20°C-23°C). The fluid management system 10 can compare the temperature measurement obtained by the temperature sensor 72 to the ambient temperature measurement in the room (accurately measured room temperature). In other cases, the fluid management system 10 can be configured such that any temperature measurement obtained by the temperature sensor greater than 25°C, greater than 28°C, or greater than 30°C is greater than room temperature and, therefore, data from the medical device 20 is safe to use. In some embodiments, the temperature measurement obtained from the temperature sensor 72 on the medical device 20 can be compared to and / or correlated with the temperature setpoint of the fluid warming system 60. In some embodiments, if the fluid warming system 60 (e.g., heater 62) is operational, the temperature measurement obtained from the temperature sensor 72 can be ignored when determining whether pressure data from the medical device 20 can be used to control fluid flow from the fluid management system.

[0094] It is contemplated that the fluid management system 10 can be programmed with a first temperature range (e.g., 20°C ± 5°C or 23°C ± 3°C) that can be considered approximately room temperature, or that an accurate room temperature measurement from an ambient temperature sensor provided with or otherwise in communication with the fluid management system 10 and a second temperature range (e.g., 37°C ± 1°C or 37°C ± 2°C) that can be considered approximately body temperature can be input into the fluid management system 10. These are examples only. Other temperature ranges can be used as needed or appropriate for environmental conditions. In some cases, the second temperature range can be selected to accommodate procedures in which the fluid management system 10 delivers fluid at temperatures above body temperature (e.g., when a laser is being used). In other cases, the second temperature range can be selected to accommodate procedures in which the fluid management system 10 delivers fluid at temperatures below body temperature.

[0095] Alternatively or additionally, pressure data obtained from the pressure sensor 74 of the medical device 20 can be compared to atmospheric pressure to determine whether the pressure data from the pressure sensor 74 of the medical device 20 can be used to assist in controlling the fluid management system 10. Initially, the controller 48 can initiate a device verification process. It is contemplated that the controller 48 can be configured to perform the device verification process at predetermined intervals during the procedure (e.g., every minute, every five minutes, etc.). In other embodiments, the controller 48 can be configured to perform the device verification process each time the fluid management system 10 attempts to control fluid flow from the fluid management system 10 using pressure data from the medical device 20. Additionally or alternatively, the device verification process can be initiated manually. For example, a physician can initiate the device verification process using the touch screen interface 42. The fluid management system 10 can then acquire pressure data from the medical device 20 while the fluid management system 10 is actively pumping fluid. In some cases, the controller 48 can poll the workstation 81 for raw pressure data for a predetermined period of time, although this is not required. In some cases, the controller 48 may instruct the workstation 81 to obtain pressure data from the medical device 20 .

[0096] It is contemplated that when the medical device 20 is within the body while the fluid management system 10 is delivering fluid, the pressure data measured by the pressure sensor 74 of the medical device 20 will be greater than atmospheric pressure. The controller 48 or workstation 81 can then determine whether the pressure data from the medical device 20 is greater than atmospheric pressure. If the pressure data obtained from the pressure sensor 74 on the medical device 20 is greater than atmospheric pressure, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10. If the pressure data obtained from the pressure sensor 74 on the medical device 20 is at or near atmospheric pressure, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10. It is contemplated that the average pressure measurement and / or root mean square (RMS) DC pressure from the pressure sensor 74 can be used to compare with atmospheric pressure.

[0097] Alternatively or additionally, data obtained from the fiber Bragg grating optical fiber 75 at the distal end 80 of the medical device 20 can be used to determine whether data from the pressure sensor 74 on the elongate shaft 76 can be used to assist in controlling the fluid management system 10. For example, the fiber Bragg grating optical fiber 75 can detect stress along the elongate shaft 76 of the medical device 20 that occurs during normal use of the medical device 20. Initially, the controller 48 can initiate a device verification process. It is contemplated that the controller 48 can be configured to perform the device verification process at predetermined intervals during the procedure (e.g., every minute, every five minutes, etc.). In other embodiments, the controller 48 can be configured to perform the device verification process each time the fluid management system 10 attempts to control fluid flow from the fluid management system 10 using pressure data from the medical device 20. Additionally or alternatively, the device verification process can be initiated manually. For example, a physician can initiate the device verification process using the touch screen interface 42. The fluid management system 10 can then acquire the stress data from a fiber Bragg grating optical fiber 75 or other stress measurement device at the distal end 80 of the elongated shaft 76 of the medical device 20. In some cases, the controller 48 can poll the workstation 81 for raw data for a predetermined period of time, although this is not required. In some cases, the controller 48 can instruct the workstation 81 to acquire the stress data from the medical device 20.

[0098] It is contemplated that the fiber Bragg grating optical fiber 75 can detect stress in the elongated shaft 76 caused by normal use of the medical device 20 when the medical device 20 is within the body. The controller 48 or workstation 81 can then determine whether stress data from the medical device 20 is detected. If stress is detected, the fluid management system 10 determines that pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10. If stress is not detected, the fluid management system 10 determines that pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10. In some cases, the stress data can be compared to a predetermined threshold. For example, if the stress is above a predetermined level, the medical device 20 is in use, whereas if the stress is at or below the predetermined level, the medical device 20 is not in use.

[0099] Alternatively or additionally, the location of the distal end 80 of the elongate shaft 76 can be tracked to determine whether the medical device 20 is in use. For example, the mapping and navigation system can include a surgical table (or other procedure or examination table or chair, etc.) that functions or is configured to function as an electromagnetic generator for generating a magnetic field of known geometry. Alternatively or additionally, an electromagnetic generator separate from the surgical table can be provided. The surgical table and / or electromagnetic generator can be coupled to a control unit that can include a processor, memory, a display, and input means, among other features.

[0100] A position sensor (e.g., an 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 to sense its location in the magnetic field of a mapping and navigation system. 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 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. When a position sensor is located within the patient, the fluid management system 10 determines that pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10. When an electromagnetic sensor is not located within the patient, the fluid management system 10 determines that pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10.

[0101] It is contemplated that it may be desirable to reduce the likelihood of erroneously determining that the medical device 20 is within the body when, in fact, it is not. For example, if a user touches the temperature sensor 72 when the medical device 20 is not within the body, the medical device 20 may communicate to the fluid management system 10 that its temperature is close to body temperature, thus generating a false positive. It is contemplated that it may be desirable to use more than one of the sensor or device verification processes described herein to determine whether the medical device 20 is within the body. It is contemplated that results from two or more device verification processes may be obtained substantially simultaneously (e.g., in parallel) or sequentially (e.g., one after the other) as desired. The fluid management system 10 may use any number of device verification processes in any combination as desired.

[0102] The controller 48 can compare these results to determine the number of device verification processes that confirmed the medical device 20 is in use with the number of device verification processes that indicate the medical device 20 is not in use. The controller 48 can then determine whether a majority of these device verification processes confirm that the medical device 20 is in use. If a majority of the device verification processes confirm that the medical device 20 is in use, the controller 48 determines that the fluid management system 10 can use pressure data from the medical device 20 to control fluid flow from the fluid management system 10. If a majority of the device verification processes do not or fail to confirm that the medical device 20 is in use, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10.

[0103] Alternatively or in addition to determining whether a majority of the device verification processes confirmed or did not confirm that the medical device 20 was being used, when at least one device verification process returns a different result than one or more additional device verification processes, the controller 48 can be configured to apply a weighted average to these results. For example, if one device verification process is deemed more accurate than other device verification processes, the more accurate device verification process can be weighted more heavily than the other device verification processes during the comparison step. Other techniques for comparing and analyzing the results from the device verification processes can be used, as desired.

[0104] FIG. 7 illustrates an exemplary display screen 44 of the controller 48. In some embodiments, the display screen 44 may include a selectable menu 44a for procedures and / or medical device types. In some embodiments, the display screen 44 may include a selectable switch 44b for turning fluid flow on or off. In some embodiments, the display screen 44 may include a user-definable flow rate selector 44c. In some embodiments, the display screen 44 may include a flow rate indicator 44d for indicating a current / actual fluid flow rate. In some embodiments, the display screen 44 may include a user-definable flush rate selector 44e. In some embodiments, the display screen 44 may include a flush button 44f for manually initiating a fluid flow burst. In some embodiments, the display screen 44 may include an intraluminal pressure display 44g that indicates the intraluminal pressure received from the medical device 20. In some embodiments, the display screen 44 may include a user-definable pressure notification setpoint 44h. In some embodiments, the display screen 44 may include a pressure limit mode switch 44i for activating automatic intraluminal pressure control by the controller 48. In some embodiments, the display screen 44 may include a fluid volume display 44j that may be user selectable to show the current amount of fluid loss or the current amount of fluid infused during the procedure. In some embodiments, the display screen 44 may include a fluid loss notification setting 44k that may be defined by the user. In some embodiments, the display screen 44 may include a vacuum pump activate switch 44m for turning the fluid collection system on or off. In some embodiments, the display screen 44 may include a fluid warmer activate switch 44n for turning the fluid warming system 60 on or off.

[0105] Those skilled in the art will recognize that the present invention may be embodied in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, changes in form and detail may be made without departing from the scope and spirit of the present invention as set forth in the claims.

[0106] Materials that can be used for the various components of the systems and their various elements disclosed herein can include those that relate to medical devices generally. For purposes of simplicity, the following discussion will be in terms of systems. However, the above associations are not intended to limit the devices and methods described herein, as this discussion can apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, fluid management systems, medical devices, elongated shafts, inflow pumps, fluid warming systems, controllers, supply lines, load cells, handles, workstations, display screens, fluid sources, collection containers, and / or these elements or components.

[0107] 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.

[0108] 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), polyetheresters (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, including but not limited to, polyethylene terephthalate (PET), polyethylene glycol (PEG), polyethylene glycols (e.g., PEG-10 ...

[0109] Some examples of suitable metals and metal alloys are stainless steels, e.g., 304V, 304L, and 316LV stainless steels, mild steel, nickel-titanium alloys, e.g., linear elastic and / or superelastic Nitinol, other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS: N06625, e.g., INCONEL® 625, UNS: N06022, e.g., HASTELLOY® C-22®, UNS: N10276 ... C276®, and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, Nickel VAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665, such as 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, including 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.

[0110] In at least some embodiments, some or all of the system and / or its components can be doped with, fabricated with, or otherwise include radiopaque materials. 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.

[0111] 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 their components or portions thereof can be fabricated from materials that do not substantially distort images and cause substantial artifacts (i.e., gaps in the images). Certain ferromagnetic materials, for example, may not be suitable because they may cause artifacts in MRI images. The systems or portions thereof can be fabricated from materials that can be imaged by MRI machines. Some materials that provide these properties 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.

[0112] In some embodiments, the systems and / or other elements disclosed herein can include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic 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 normal 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), anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine), anticoagulants (D- These agents may include 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 tick antiplatelet peptides, vascular cell proliferation promoters (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters, etc.), vascular cell proliferation inhibitors (growth factor inhibitors, growth factor receptor antagonists, transcription repressors, 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, etc.), cholesterol-lowering drugs, vasodilators, and drugs that interfere with endogenous vasoactive mechanisms.

[0113] It should be understood that the present disclosure is in many respects illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the invention. This may include, where appropriate, the use of any of the features of one illustrative embodiment used in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed. [Explanation of symbols]

[0114] 20 Medical Devices 76 Thin Shaft 80 distal end of elongated shaft 82 Handle 89 Power supply

Claims

1. 1. A fluid management and medical device system comprising: a medical device and a fluid management system, the medical device comprises: an elongate shaft configured to access a treatment site within a patient; one or more sensors proximal to the distal end of the elongate shaft; a handle coupled to the proximal end of the elongate shaft; The fluid management system comprises: a fluid supply operatively coupled to a supply load cell and in fluid communication with the elongated shaft; a collection container operatively coupled to the collection load cell and in fluid communication with the collection drape; an inflow pump configured to pump fluid from the fluid source to the treatment site; a controller configured to control the inflow pump based on a set of system operating parameters to maintain a desired fluid pressure or a desired fluid flow rate at the treatment site; the controller is in electronic communication with the source load cell and the collection load cell; The fluid management and medical device system, wherein the controller is configured to calculate a fluid deficit using a rotational speed of the inflow pump along with a difference between a weight change of the fluid source and a weight change of the collection container.

2. The fluid management and medical device system of claim 1 , wherein the controller is configured to calculate the fluid deficit only when the distal end of the elongate shaft is positioned within the patient.

3. The fluid management and medical device system of claim 2 , wherein the controller is configured to automatically suspend fluid deficit calculations when the distal end of the elongate shaft is removed from the patient.

4. The fluid management and medical device system of claim 3 , wherein the controller is configured to automatically resume fluid deficit calculation when the distal end of the elongate shaft is reinserted into the patient.

5. The fluid management and medical device system of claim 1 , wherein the controller is configured to notify a user when the fluid deficit reaches a preset fluid deficit limit.

6. The fluid management and medical device system of claim 1 , wherein the controller is configured to automatically reset a fluid deficit to zero after priming of the fluid management system.

7. the controller is configured to calculate a first fluid deficit value using a flow rate of the fluid and a second fluid deficit value using the difference between the weight change of the fluid source and the weight change of the collection container; The fluid management and medical device system of claim 1 , wherein the displayed deficit value is based on a combination of the first fluid deficit value and the second fluid deficit value.

8. The fluid management and medical device system of claim 7 , wherein the fluid flow rate is determined using a rotational speed of the inflow pump.

9. 10. The fluid management and medical device system of claim 7, wherein the fluid flow rate is determined using data from a flow sensor positioned between the fluid source and the treatment site.

10. the controller is configured to display the displayed deficit value when a difference between the first fluid deficit value and the second fluid deficit value is within a predetermined range; 8. The fluid management and medical device system of claim 7, wherein the controller is configured to display a notification if a difference between the first fluid deficit value and the second fluid deficit value is outside a predetermined range.

11. A fluid management and medical device system as described in any one of claims 1 to 10, wherein the one or more sensors include a temperature sensor.

12. A fluid management and medical device system as described in any one of claims 1 to 10, wherein the one or more sensors include a pressure sensor.

13. A fluid management and medical device system as described in any one of claims 1 to 10, wherein the one or more sensors include a temperature sensor and a pressure sensor.

14. A fluid management and medical device system as described in any one of claims 1 to 10, wherein the fluid management system includes a vacuum pump in fluid communication with the collection container.

15. The fluid management and medical device system of any preceding claim, wherein fluid deficit calculations continue uninterrupted as the fluid supply is replenished.

16. 1. A fluid management and medical device system comprising: a medical device and a fluid management system, the medical device comprises: an elongate shaft configured to access a treatment site within a patient; one or more sensors proximal to the distal end of the elongate shaft; a handle coupled to the proximal end of the elongate shaft; The fluid management system comprises: a fluid supply operatively coupled to a supply load cell and in fluid communication with the elongated shaft; a collection container operatively coupled to the collection load cell and in fluid communication with a vacuum pump; an inflow pump configured to pump fluid from the fluid source to the treatment site; a controller configured to control the inflow pump based on a set of system operating parameters to maintain a desired fluid pressure or a desired fluid flow rate at the treatment site; the controller is in electronic communication with the source load cell and the collection load cell; The fluid management and medical device system, wherein the controller is configured to calculate a fluid deficit using a rotational speed of the inflow pump along with a difference between a weight change of the fluid source and a weight change of the collection container.

17. the controller is configured to calculate a first fluid deficit value using a flow rate of the fluid and a second fluid deficit value using the difference between the weight change of the fluid source and the weight change of the collection container; 17. The fluid management and medical device system of claim 16, wherein the displayed deficit value is based on a combination of the first fluid deficit value and the second fluid deficit value.

18. 18. The fluid management and medical device system of claim 16 or 17, wherein the controller is configured to calculate the fluid deficit only when the distal end of the elongate shaft is positioned within the patient.

19. 20. The fluid management and medical device system of claim 18, wherein the controller is configured to automatically suspend fluid deficit calculations when the distal end of the elongate shaft is removed from the patient.

20. 20. The fluid management and medical device system of claim 19, wherein the controller is configured to automatically resume fluid deficit calculation when the distal end of the elongate shaft is reinserted into the patient.

Images