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 of U.S. Provisional Patent Application No. 62 / 928,005, filed Oct. 30, 2019, the entire disclosure of which is hereby incorporated by reference.

[0002] The disclosure of the present invention relates to a fluid management system. More specifically, the disclosure of the present invention relates to systems and methods for monitoring fluid loss in and / or by a fluid management system.

Background Art

[0003] Flexible ureteroscopy (fURS), gynecological endoscopic procedures, and other endoscopic procedures require fluid circulation for several reasons. Today's surgeons deliver fluid in various ways, such as by suspending a fluid bag and using gravity to deliver the fluid, filling a syringe with fluid and injecting it manually, or using a peristaltic pump to deliver fluid from a reservoir through a fluid management system at a fixed pressure or flow rate. The fluid management system can adjust the flow rate and / or pressure based on data collected from a treatment device such as an endoscope, although not limited to when delivering fluid from the reservoir. Known medical devices, systems, and methods each have certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and fluid delivery systems.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0005] In 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 a 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 disposed 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 instead of any of the examples disclosed herein, the controller can be configured to resume the fluid deficit calculation 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 instead of 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] In addition to or instead of any of the examples disclosed herein, the controller can be configured to automatically reset the fluid deficit to zero after priming of the fluid management system.

[0009] In addition to or instead of any of the examples disclosed herein, the controller can be configured to automatically initiate the 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] In addition to or instead of any of the examples disclosed herein, one or more sensors include a temperature sensor.

[0011] In addition to or instead of any of the examples disclosed herein, one or more sensors include a pressure sensor.

[0012] In addition to or instead of any of the examples disclosed herein, one or more sensors include a temperature sensor and a pressure sensor.

[0013] In addition to or instead of any of the examples disclosed herein, the fluid management system includes a vacuum pump and a collection container in fluid communication with a collection drain.

[0014] In addition to or instead of any of the examples disclosed herein, the fluid deficit calculation continues without interruption when the fluid supply source is replenished.

[0015] In addition to or instead of any of the examples disclosed herein and in a second example, the 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 the 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 supply 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 a collection drain, an inflow pump configured to pump fluid from the fluid supply 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 communicate electronically with the supply load cell and the collection load cell. The controller can be configured to calculate a fluid deficit using the rotational speed of the inflow pump along with the difference between the change in weight of the fluid supply source and the change in weight of the collection container.

[0016] In addition to or instead of any of the examples disclosed herein, the controller can be configured to calculate fluid loss only when the distal end of the elongate shaft is disposed within the patient.

[0017] In addition to or instead of any of the examples disclosed herein, the controller can be configured to automatically interrupt fluid loss calculations when the distal end of the elongate shaft is removed from the patient.

[0018] In addition to or instead of any of the examples disclosed herein, the controller can be configured to calculate a first fluid loss value using the flow rate of the fluid and a second fluid loss value using the difference between the weight change of the fluid source and the weight change of the collection container. The displayed loss value can be based on a combination of the first fluid loss value and the second fluid loss value.

[0019] In addition to or instead of any of the examples disclosed herein, the flow rate of the fluid is determined using the rotational speed of the inflow pump.

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

[0021] In addition to or instead of any of the examples disclosed herein, the controller can be configured to display the displayed loss value when the difference between the first fluid loss value and the second fluid loss value is within a predetermined range. The controller can be configured to display a notification when the difference between the first fluid loss value and the second fluid loss value is outside the predetermined range.

[0022] In addition to or instead of any of the examples disclosed herein and in a third example, the 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 the distal end of the elongate shaft, and a handle coupled to the 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 the total fluid deficit to zero after priming of 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 disposed within the patient. The controller can be configured to maintain 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 then be configured to calculate the 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 disposed within the patient.

[0023] In addition to or instead of any of the examples disclosed herein, the controller can be configured to notify the user when the total fluid deficit reaches a pre-set fluid deficit limit.

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

[0025] In addition to or instead of any of the examples disclosed herein, the controller can be configured to automatically resume fluid deficit calculations when the distal end of the elongate shaft is re-inserted into the patient.

[0026] In addition to or instead of 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 disposed within the patient.

[0027] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment of the disclosure of the present invention or to describe any implementation. The following figures and detailed description more specifically illustrate these embodiments.

[0028] The present invention can be more fully understood by examining the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0029]

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[0030] The present invention readily admits of various modifications and alternative forms, and the details thereof are shown by way of example in the drawings and will be described in detail below. However, it is to be understood that the intention is not to limit the present invention to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention.

Best Mode for Carrying Out the Invention

[0031] The following description is not necessarily to scale and must be read with reference to the drawings, in which like reference numerals indicate like elements through several figures. These detailed descriptions and the 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 disclosure of the invention. These detailed descriptions and the drawings specifically show exemplary embodiments of the claimed invention. However, for purposes of clarity and to facilitate understanding, not all features and / or elements are shown in each drawing, but nevertheless, these features and / or elements can be understood to exist unless otherwise specified.

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

[0033] In this specification, it is assumed that all numerical values are modified by the term "about," whether or not so specified. The term "about" in the context of numerical values generally means a range of numbers that are considered equivalent (e.g., having the same function or result) to the values recited by those skilled in the art. In many instances, the term "about" can include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) can be understood from the context of this specification and are assumed to have the ordinary and customary definition of this term that is consistent therewith, unless otherwise specified.

[0034] The recitation of numerical ranges by endpoints includes all numbers within that range including the endpoints (e.g., from 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0035] Discloses some suitable dimensions, ranges, and / or values for various components, features, and / or specifications, but those skilled in the art evoked by the disclosure of the present invention will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0036] As used in this specification and the claims, "a", "an", and "the" include singular referents and plural referents unless the context clearly dictates otherwise. As used in this specification and the claims, the term "or" is generally used in a sense that includes "and / or" unless the context clearly dictates otherwise. For ease of understanding, certain features of the disclosure of the present invention may be described in the singular, but it should be noted that these features may be plural or may be repeated within embodiments of the disclosure of the present invention. Each instance of these features may, unless the contrary is explicitly stated, include and / or be encompassed by the disclosure in the singular. For purposes of simplification and clarity, not all elements of the invention of the disclosure of the present invention are necessarily illustrated in each figure and discussed in detail below. However, it will be understood that the following discussion may equally apply to any and / or all of these components unless the contrary is explicitly stated for cases where there are more than one component. In addition, for purposes of clarity, all instances of some elements or features may not be shown in each figure.

[0037] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof can generally be determined with respect to the positioning, orientation, and / or manipulation of various elements relative to the user / operator / manipulator of the device, where "proximal" and "retreating" indicate or mean closer to or towards the user, and "distal" and "advancing" indicate or mean farther from or away from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily assigned in an attempt to facilitate understanding of the disclosure of the present invention, but such instances will be readily apparent to those of ordinary skill in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" mean the direction of fluid flow within a body lumen, such as a blood vessel, or within a device.

[0038] The term "limit" can be understood to mean the greatest measured dimension being described or illustrated, unless the term "minimum" is prefixed to such limit or dimension or such limit or dimension is otherwise indicated as "minimum", in which case it can be understood to mean the smallest measured dimension being described or illustrated. For example, "outer limit" can be understood to mean outer dimension, "radial limit" can be understood to mean radial dimension, "longitudinal limit" can be understood to mean longitudinal dimension, and so on. Each instance of "limit" can vary (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to those of ordinary skill in the art from the individual context of use. Generally, a "limit" can be considered the maximum possible dimension measured according to the intended use, whereas a "minimum limit" can be considered the minimum possible dimension measured according to the intended use. In some instances, a "limit" can generally be measured orthogonally within a plane and / or cross-section, but as will be apparent from the particular context, for example, without limitation, it can be measured otherwise in an angular, radial, circumferential (e.g., along an arc) direction, etc.

[0039] The terms "integral" and "unitary" shall generally mean one or more elements manufactured from or consisting of a single structure or base unit / element. Integral and / or unitary elements exclude structures and / or features manufactured by assembling or otherwise joining together a plurality of individual elements.

[0040] Note that references in this specification to "embodiments", "some embodiments", "other embodiments", etc., indicate that the embodiments being described may include certain features, structures, or characteristics, but not all embodiments necessarily include the certain features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in relation to an embodiment, whether explicitly described or not, it is considered within the knowledge of one of ordinary skill in the art to cause these particular features, structures, or characteristics in relation to other embodiments, unless the contrary is explicitly stated. That is, as will be understood by one of ordinary skill in the art, the various individual elements described below can still be combined or arranged with each other to form other additional embodiments or to complement and / or expand the described embodiments even if not specified in a particular combination.

[0041] For purposes of clarity, a certain identification numeral nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout this specification and / or the claims to name and / or distinguish between the various features being described and / or claimed. It is understood that this numeral nomenclature is not intended to be limiting, but is merely illustrative. In some embodiments, for purposes of brevity and clarity, changes and departures from the previously used numeral nomenclature may be made. That is, a feature shown as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be completely excluded, and / or different features may be referred to as a "first" element. The meaning and / or designation in each case 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, but not limited to, can adjust the body cavity pressure using pressure data and / or temperature data from the or other endoscopic devices when used in combination with an endoscopic device such as a LithoVue® scope device. Direct adjustment of the intracavitary pressure during a medical procedure can enable the fluid management system to safely drive system pressures up to 600 mmHg and ensure no loss of flow during the procedure when inserting a tool into the working channel of the endoscopic device. Fluid deficit can be a concern for physicians, for example, during procedures that use fluid over a long period of time and / or in large volumes. Patient absorption of excess fluid can result in serious complications such as edema / hypervolemia and / or septic conditions, for example, during BPH / TURP in cases of high pressure and / or large volume. Determining acceptable fluid loss (e.g., fluid deficit) can be difficult as it may vary from patient to patient and procedure to procedure. In addition, tracking the amount of fluid infused can be difficult as multiple fluid sources (e.g., saline bags, glycine, etc.) may be used during the procedure. Calculating fluid deficit can also be difficult as fluid lost outside the collection system (e.g., on the floor) may escape inclusion in the calculation due to the calculation depending on the waste collection system. As a result, in some procedures, 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] FIG. 1 is a schematic diagram of a fluid management system 10 that can be used for endoscopic procedures such as the fURS procedure. The fluid management system 10 can be coupled to a medical device 20 that includes a pressure sensor allowing fluid flow to pass therethrough. The 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 supplies in vivo temperature feedback to the fluid management system 10, a pressure sensor that supplies in vivo pressure feedback to the fluid management system 10, and / or a camera that supplies visual feedback to the fluid management system 10.

[0044] Briefly described, the fluid management system 10 can include an inflow pump 50 configured to pump and / or convey fluid from a fluid source 34 (e.g., a fluid bag, etc.) to the medical device 20 and / or a treatment site. In some cases, the fluid can pass through a fluid warming system 60 before flowing into the medical device 20. The fluid flow rate, fluid pressure, fluid temperature, and other operating parameters can be controlled or at least partially controlled by the controller 48. The controller 48 can 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 supply control commands, and / or data can be transmitted or received between the controller 48 and these. For example, as described in more detail herein, the controller 48 can receive data such as pressure data and temperature data from the medical device 20, although not limited thereto. The controller 48 can 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 flow rate at the treatment site.

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

[0046] In some embodiments, the fluid management unit can include a collection container 26 in fluid communication with a vacuum pump 24 and a collection drain 28. In some embodiments, the vacuum pump 24 can include a plurality of vacuum pumps. In some embodiments, the collection container 26 can include a plurality of containers, canisters, and / or other receptacles fluidly connected to each other and / or to the vacuum pump 24. In some embodiments, the collection drain 28 can include a plurality of collection drains. The vacuum pump 24 can be operatively and / or electronically connected to a controller 48. In some embodiments, as shown in FIG. 1, the vacuum pump 24 can be disposed adjacent to and / or near the collection container 26. In some embodiments, the vacuum pump 24 can be disposed within the fluid management system 10. Other configurations are also conceivable. In some embodiments, the collection container 26 can be operatively coupled to a collection load cell 25 to detect the placement and / or weight of the collection container 26. In embodiments having a plurality of containers, canisters, and / or other receptacles, each container, canister, and / or other receptacle can be operatively coupled to a corresponding collection load cell 25. The controller 48 can communicate electronically with the collection load cell 25.

[0047] The fluid management system 10 can 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 can include switches or knobs in addition to the touch function. In some embodiments, the controller 48 can include the touch screen interface 42 and / or the display screen 44. The touch screen interface 42 enables a user to input / regulate various functions of the fluid management system 10 such as, for example, flow rate, pressure, or temperature. The user can include parameters and alarms (but not limited to, such as maximum pressure alarms), displayed information, and procedure modes. The touch screen interface 42 enables a user to add, switch, and / or interrupt the use of various modular systems within the fluid management system 10. The touch screen interface 42 can be used to switch the fluid management system 10 between an automatic mode and a manual mode for various procedures. Instead of or in addition to the touch screen interface 42, it is contemplated that other systems configured to receive user input can be used.

[0048] As will be understood by those skilled in the art, the touch screen interface 42 can be configured to include selectable areas such as buttons and / or can provide functions similar to physical buttons. The display screen 44 can be configured to show icons related to modular systems and devices included within the fluid management system 10. Further, the display screen 44 can include a flow rate display. The flow rate display can be determined based on, for example, a desired threshold or a known typical value for the flow rate set by the user prior to the procedure. In some embodiments, the operating parameters can be adjusted by touching the corresponding portion of the touch screen interface 42. The touch screen interface 42 can provide visual and / or audible warnings when parameters (such as 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 that the user determines to be 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 various modular systems. For example, the flow rate can be manually controlled using the optional foot pedal 46. Some exemplary display screens 44 and other user interface components are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," assigned to the applicant of the present invention, and the entire disclosure of this document is hereby incorporated by reference.

[0049] The touch screen interface 42 can be operatively connected to or be part of the controller 48. The controller 48 can be a tablet computer or other processing device. The controller 48 can be operatively connected to one or more system components such as, for example, an inflow pump 50, a fluid warming system 60, and a fluid deficit management system. In some embodiments, these features can be integrated into a single unit. The controller 48 has functions to perform various functions such as computing, controlling, computer, and displaying, and is configured to perform these functions. The controller 48 also has a function to track and store data regarding the operation of the fluid management system 10 and each of its components. In an exemplary embodiment, the controller 48 includes wired and / or wireless network communication functions such as Ethernet or Wi-Fi that enable the controller 48 to be connected to, for example, a local area network. The controller 48 can receive signals from one or more of a plurality of sensors of the fluid management system 10. In some embodiments, the controller 48 can communicate with a database for the purpose of best medical advice and patient record maintenance, and these can be displayed to the user on the display screen 44.

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

[0051] The controller 48 can be configured to include visual software / image recognition software that can detect visual noise based on changes in luminance (e.g., optical monitor), contrast, or color pixelation. If it is determined that the image supplied to the controller 48 is not sufficiently clear or sharp, the fluid management system 10 can increase the fluid flow rate or fluid pressure to flush debris from the treatment site and clarify / sharpen the image. The fluid flow rate or fluid pressure can be increased over a temporary period of time (a predetermined period) or until the field of view is deemed to be sufficiently clear. This temporary increase ensures that the time for increasing the fluid flow rate or fluid pressure is limited so as to ensure that the intracavitary pressure does not exceed the safety limit. For example, the fluid management system 10 can recognize the red hue (sign of blood) in the cleaning fluid and signal the inflow pump 50 to increase the fluid flow rate or fluid pressure until the blood is removed from the field of view. Alternatively, the controller 48 can provide a visual warning on the display screen 44 that a cloudy field of view has been detected to the physician or nurse or provide an audible warning, and then the user can manually adjust the cleaning fluid flow rate. In another example, in cases where there is a significant amount of debris, the light reflected from the debris may substantially increase the luminance of the image. In this context, the controller 48 can detect this excessive luminance and signal 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 flushed and removed from the field of view of the imaging system, the inflow pump 50 is controlled by the controller 48 to reduce the fluid flow rate or fluid pressure. In some cases, the physician can generate baseline visibility levels where it is considered beneficial to cause a fluid flow to clarify the field of view and enter these parameters into the fluid management system 10 through the touch screen interface 42 prior to the procedure. Once the baseline is generated, the fluid management system 10 can monitor the visual feed regarding changes in the video and automatically adjust the fluid flow rate as needed.

[0052] To regulate fluid flow rate or fluid pressure by the fluid management system 10, the fluid management unit can include one or more pressurizing devices such as the 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 driven and can receive power from a power line source such as a wall outlet, an external or internal power storage device such as a disposable battery or a rechargeable battery, and / or an internal power source. The inflow pump 50 can be operated at any desired speed sufficient to deliver the fluid at a target pressure such as, for example, from 5 mmHg to 50 mmHg, and / or a target fluid flow rate or target fluid pressure. As noted herein, the inflow pump 50 can be automatically adjusted based on, for example, readings of pressure and / or temperature 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 can be a separate user interface that includes buttons that allow the user to increase or decrease the inflow pump 50. Alternatively, the fluid controller can be incorporated within the main processing device and can receive input through the touch screen interface 42. It will be understood that any number of pumps can be used. In some embodiments, the fluid management system 10 can include multiple pumps having various pumping functions. In some embodiments, a flow meter can be positioned before and / or after the inflow pump 50.

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

[0054] In some embodiments, the fluid management system 10 can include visual software or image recognition analysis software. For example, the fluid management system 10 can detect whether a tool has been inserted or is being used by a camera 70 (see, e.g., FIGS. 2 and 3) disposed on the medical device 20 within the body. The tool can have an identifiable marker that can be confirmed by the visual software to notify the fluid management system 10, for example, of 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 visual software. Thus, when the tool is withdrawn from the operating channel, the fluid management system 10 can automatically reduce the fluid flow rate or fluid pressure.

[0055] In addition to or instead of this, the fluid management system 10 can automatically adjust the fluid flow rate or fluid pressure based on the temperature and / or pressure within the cavity detected within the treatment site. The temperature and / or pressure within the cavity can be measured in situ using a temperature sensor 72 and / or a pressure sensor 74 mounted on the medical device 20 in combination with the fluid management system 10. The fluid management system 10 can include pressure monitor software that can be configured by the user to automatically start, stop, and / or adjust the speed of the inflow pump 50 by the fluid management system 10 to maintain the pressure of the fluid delivered to the treatment site within a target pressure and / or a predetermined pressure range. For example, the pressure sensor 74 can detect the pressure within the treatment site (e.g., the kidney or uterus) and automatically change the fluid flow rate or fluid pressure within the fluid management system 10 based on the intracavitary pressure (e.g., intrarenal or intrauterine pressure) being monitored. When the intracavitary pressure is excessively high, the fluid management system 10 can reduce the fluid flow rate or fluid pressure, and when the intracavitary pressure is excessively low, the fluid management system 10 can increase the fluid flow rate or fluid pressure. In an exemplary temperature control mode, the fluid management system 10 can include temperature monitor software that can control (e.g., start, stop, and adjust the temperature) the fluid heating system 60 to maintain the temperature of the fluid delivered to the treatment site within approximately a target temperature and / or a predetermined temperature range. For example, the temperature can be monitored in vivo or in vitro, and the fluid flow can be changed based on the supplied temperature feedback. In the illustrated embodiment, the fluid management system 10 can compare the temperature and / or pressure sensed within the treatment site with known values and provide an alert when the parameters are outside a predetermined safe range. The alert can be a visual warning or an auditory 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, for example. The fluid management system 10 can calculate a movement speed based on the original and new positions of the target structure or object. When the movement exceeds a predetermined threshold value, the user can be warned to manually adjust the fluid flow rate or fluid pressure of the fluid management system 10. As described herein, the fluid flow rate or fluid pressure can be manually adjusted through an optional foot pedal 46, a touch screen interface 42, and / or a pump interface. In some embodiments, the fluid management system 10 will automatically adjust the fluid flow rate or fluid pressure as needed when in the automatic mode. This feature can be very advantageous for controlling the backward propulsion of the target structure or object during a procedure such as lithotripsy.

[0057] Figures 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 the ureteroscope. The medical device 20 can be configured to deliver fluid from the fluid management system 10 to a treatment site through an elongate 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 elongate shaft 76. The elongate shaft 76 can include one or more working lumens for receiving the fluid flow or other medical devices passing therethrough. As shown in FIG. 4, which is a schematic view of the medical device 20 disposed in the 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., tubes).

[0058] In some embodiments, the medical device 20 can communicate electronically with the workstation 81 through the wired connection portion 79. The workstation 81 can include, among other features, a touch panel computer 83, an interface box 85 for receiving the wired connection portion 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 portion 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 processing processor. In some embodiments, the workstation 81 can be a multi-purpose component (e.g., used for more than one procedure), while the medical device 20 can be a single-use device, although this is not essential. In some embodiments, the workstation 81 can be excluded, and the medical device 20 can be electronically directly coupled 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 attenuate the peristaltic motion 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 the 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 the display screen of the touch panel computer 83. In another embodiment, the medical device 20 can include two cameras 70 having different communication requirements or protocols such that each can communicate different information to the user. When so provided, the user can optionally switch between these cameras 70 through the touch screen interface 42 and / or the touch panel computer 83. Although not specified, the elongate shaft 76 can include one or more working lumens for receiving fluids and / or other medical devices.

[0060] 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 enables 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 so that the user can emit laser energy. In an exemplary embodiment, the laser can be a laser from Lumenis or StarMed Tech. 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 such that energy is emitted from the tip of the laser fiber and strikes debris / stones to break them. In an exemplary embodiment that includes a laser button on the handle 82, a communication line (e.g., wired or wireless) is maintained between the laser system and the handle 82. Although this exemplary embodiment describes a ureteroscope, it will be understood that the features detailed above can be directly integrated into virtually any device having a cystoscope, endoscope, hysteroscope, or imaging function. In some embodiments, the medical device 20 can further include a drainage port 88 that can be connected to a drainage system. Some exemplary drainage systems are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," assigned to the applicant of the present invention, the disclosure of which is hereby incorporated by reference.

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

[0062] Prior to starting the procedure, it may be necessary to prime or fill the fluid management system 10 to remove any air from the system. Some fluid may be lost as a result of priming the fluid management system 10. In some embodiments, the controller 48 can be configured to automatically reset the fluid deficit to zero after priming the fluid management system 10. In some embodiments, the controller 48 can 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 a patient. In some embodiments, the controller 48 can be configured to automatically interrupt the fluid deficit calculation when the distal end 80 of the elongate shaft 76 has been 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 disposed within a patient will be discussed later. In some embodiments, the controller 48 can be configured to automatically resume the fluid deficit calculation when a signal from one or more sensors indicates that the distal end 80 of the elongate shaft 76 has been re-inserted 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 disposed within the patient.

[0063] In an alternative embodiment, the fluid deficit calculation can begin after the initial setup of the system (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 rotation speed, flow sensor data, the weight change of the fluid supply source 34, or other suitable means. After priming of 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 the heater cassette 64 can define and / or enclose a known fluid volume. The controller 48 can be configured to exclude this known fluid volume of the supply line 78 and / or the heater cassette 64 from the fluid deficit calculation.

[0064] In addition, in some embodiments, the fluid deficit calculation can continue without interruption when the fluid source 34 is replenished. For example, if the fluid source 34 is replaced or refilled during the procedure, the procedure continues. Thus, the fluid deficit being calculated by the controller 48 can also continue to maintain the total fluid deficit throughout the procedure. Thus, 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 disposed within a patient. If the first fluid source 34 runs low or runs out during the procedure, the first fluid source 34 can be replaced with, thereby replenished by, and / or refilled with the second fluid source 34. The controller 48 can be configured to hold the first fluid deficit when the first fluid source 34 is replaced with the second fluid source 34 in fluid communication with the elongate shaft 76, and then 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 disposed within the patient.

[0065] In some embodiments, the controller 48 can be configured to notify the user when the total fluid deficit reaches a pre-set 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 pre-set fluid deficit limit.

[0066] In some embodiments, the controller 48 can be configured to notify the user when the total amount of the injected fluid reaches a preset fluid injection 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 the injected fluid reaches a preset fluid injection limit.

[0067] In some embodiments, the controller 48 can be configured to monitor the amount of fluid in the fluid supply source 34 through weight using, for example, 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 source 34 attached to the fluid supply source hanger 32 and compare the initial amount of fluid in the fluid supply source 34 with the current amount of fluid remaining in the fluid supply source 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 warn the physician of how much fluid remains in the fluid supply source 34, and then this amount can be used to determine how much fluid has been injected 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 source 34 is needed based on the weight of the fluid supply source 34 and the rate at which the fluid supply source 34 is emptied (e.g., the fluid flow rate). In some embodiments, the amount of fluid remaining in the fluid supply source 34 can be indicated. For example, when 10% of the fluid remains in the fluid supply source 34, a warning can be indicated on the display screen 44 by an audible signal. In some embodiments, the supply load cell 94 can be connected to the display screen 44 through a wireless (e.g., WiFi) signal. In some embodiments, the supply load cell 94 can be connected to the display screen 44 through a wired connection.

[0068] Similarly, the controller 48 can be configured to monitor the amount of fluid in the collection container 26 through weight, using, for example, the collection load cell 25, graduations, 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 with the current amount of fluid in the collection container 26. The readings of the collection load cell 25 can be shown to the user on the display screen 44. As the procedure progresses, the readings of the collection load cell 25 can be updated in real time to alert the physician as to how much fluid is present in the collection container 26, and then this amount can be used to determine how much fluid has been collected from the patient and / or the collection drain 28. In some embodiments, the fluid management system 10 and / or the controller 48 can provide the 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 supply source 34 is emptied (e.g., fluid flow rate). In some embodiments, the amount of fluid in the collection container 26 can be indicated. For example, when only 10% of the initial empty volume remains in the collection container 26, a warning can be indicated on the display screen 44 by an audible signal. In some embodiments, the collection load cell 25 can be connected to the display screen 44 through a wireless (e.g., WiFi) signal. In some embodiments, the collection load cell 25 can be connected to the display screen 44 through a wired connection.

[0069] In some embodiments, the fluid deficit calculation can continue without interruption when the collection container 26 becomes empty or is replaced. For example, if the collection container 26 becomes empty or is replaced during the procedure, the procedure continues. Thus, the fluid deficit being calculated by the controller 48 can also continue to maintain the total fluid deficit throughout the procedure. When the collection container 26 becomes full during the procedure, the collection container 26 can be emptied and returned to a ready state, or replaced with an empty collection container. In some embodiments, the controller 48 can be configured to hold the fluid volume in the collection container 26 and then calculate the total fluid deficit by adding the fluid volume in the collection container 26 to a second fluid volume associated with the empty collection container or replacement collection container when the distal end 80 of the elongate shaft 76 is disposed within the patient.

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

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

[0072] The fluid management system 10 can be connected to various components using the supply line 78. In some embodiments, the supply line 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 may vary depending on the application. The supply line 78 and / or the tubing can be disposable items and can be provided sterile and ready for use. Different types of tubing can be used for different functions within the fluid management system 10. For example, one type of tubing can be used for heating the fluid and controlling the fluid flow to the medical device 20, while another type of tubing can be used for flushing within the body and / or at the treatment site.

[0073] In some embodiments, the fluid management system 10 can include a fluid warming system 60 for warming the fluid that is to be delivered to the patient 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 the fluid flow so that the heater 62 can be reused with minimal maintenance. The heater cassette 64 can be formed, for example, of polycarbonate or any high heat-rated biocompatible plastic and can be formed as a single unitary part and integral part or multiple parts permanently joined to each other. In some embodiments, the heater cassette 64 can include a fluid inlet port 61 and a fluid outlet port 63 positioned on its side. The fluid inlet port 61 and the fluid outlet port 63 can be configured to each couple to a supply line 78 of the fluid management system 10. For example, the fluid inlet port 61 can couple the fluid supply source 34 to the fluid warming system 60 (through the inflow pump 50), whereas the fluid outlet port 63 can couple the fluid warming system 60 to the medical device 20, each coupling being through the supply line 78.

[0074] In some embodiments, the heater cassette 64 can include an internal flow path along a channel that enables fluid to flow through from the fluid inlet port 61 to the fluid outlet port 63. The heater cassette 64 can include one or more flow channels. In some embodiments, the channel can pass through a susceptor 66 that can enable the fluid to be heated by induction heating. When the heater cassette 64 is coupled to the heater 62, the susceptor 66 can be configured to be disposed within the induction coil 68. Optionally, other fluid warming system configurations and methods can be used. For example, the heater 62 can include one or more heat sources, such as a platen system or a series coil that uses, for example, electrical energy, within the supply line 78. The heating can be specially designed and adapted to match 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 applicant of the present invention, and the entire disclosure of this document is hereby incorporated by reference.

[0075] Although not explicitly shown, the fluid warming system 60 can include a heater user interface separate from the touch screen interface 42. The heater user interface can simply be a display screen that provides a digital display of the internal temperature of the heater 62. In another embodiment, this user interface can further include temperature adjustment buttons for increasing or decreasing the temperature of the heater 62. In this embodiment, the heater user interface and / or the display screen can include the current temperature of the heater 62, as well as the target temperature to be reached. Note that all information output from the fluid warming system 60 can be directly communicated to the display screen 44 so as not to require a heater user interface.

[0076] The fluid heating system 60 can include one or more sensors configured to monitor the fluid flowing therethrough. For example, a temperature sensor 65 can be mounted within the fluid heating system 60 to detect the temperature of the fluid flowing through the heater cassette 64. The temperature sensor 65 can be positioned at or near the fluid inlet port 61 and / or the fluid outlet port 63. In some embodiments, the temperature sensor 65 can be mounted to detect the temperature of the fluid flowing through the heater cassette 64 before the fluid enters the susceptor 66 and after the fluid exits the susceptor 66. In some embodiments, an additional sensor can be positioned at an intermediate portion of the susceptor 66 to detect the progression of the temperature rise of the fluid within the heater cassette 64. The temperature sensor 65 can transmit any information remotely to the display screen 44, or can transmit information thereto if the heater user interface and / or its display screen is so provided. In another embodiment, the temperature sensor 65 can be wired (if provided) to the heater user interface, in which case the heater user interface can remotely communicate the desired information to the display screen 44. Alternatively or in addition, the temperature sensor 65 can be connected to and / or wired to the controller 48.

[0077] The heater 62 can further include a pressure sensor 67 and / or a bubble sensor 69. The heater cassette 64 can include corresponding pressure sensor interfaces 71 and bubble sensor interfaces 73 that enable the pressure sensor 67 and the bubble sensor 69, respectively, to monitor the fluid flowing through the heater cassette 64 when it is coupled to the fluid warming system 60. The pressure sensor 67 and / or the bubble sensor 69 can remotely transmit any information to the display screen 44, or can transmit information thereto if the heater user interface and / or its display screen are so provided. In another embodiment, the pressure sensor 67 and / or the bubble sensor 69 can be wired to the heater user interface (if provided), in which case the heater user interface can remotely communicate the desired information to the display screen 44. Alternatively or in addition, the pressure sensor 67 and / or the bubble sensor 69 can be connected to and / or wired to the controller 48.

[0078] FIG. 6 is a schematic block diagram showing the fluid management system 10 and the medical device 20. As described herein, there can be two primary interfaces including one or more mechanical connections (e.g., supply line 78) fluidly coupling the medical device 20 to the heater cassette 64 between the fluid management system 10 and the medical device 20, and one or more wired or wireless communication connections 91 (e.g., Ethernet cord, WiFi, etc.) coupling the 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 adjust the fluid flow rate or fluid pressure using the pressure data from the medical device 20 when a user-specified value or a predetermined pressure limit is reached.

[0079] However, during a typical lithotripsy procedure, for example, the fluid management system 10 may be connected to multiple endoscopes or other medical devices. Similarly, in procedures where both the medical device 20 having the pressure sensor 74 and the fluid management system 10 are used, the controller 48 and the workstation 81 may be connected in an OR readiness stage and may remain connected throughout the procedure. This can mean that when the medical device 20 is connected to the workstation 81, the workstation 81 can transmit 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 can be configured to determine when it is safe to use the pressure data from the medical device 20 to adjust the intracavitary pressure. In some embodiments, this can be done by asking the user to select the type of medical device 20 being used on the touch screen interface 42. When the physician selects a device other than the medical device 20, the controller 48 of the fluid management system 10 can ignore the pressure data being transmitted from the medical device 20.

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

[0081] When the medical device 20 is in use in combination with the fluid management system 10, the medical device 20 may be exposed to some of the 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 that it is safe to limit the fluid pressure based on the pressure data from the medical device 20.

[0082] A pulsatile pressure source may occur within the fluid management system 10. For example, the inflow pump 50 may generate a unique fingerprint within 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 can be a function of the pump head roller of the pump head and the revolutions per minute (RPM). When the medical device 20 is connected to the fluid management system 10, this fingerprint can be measured by the medical device 20 and compared to the signature achieved by the inflow pump 50 of the fluid management system 10. When 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 is connected to the fluid management system 10.

[0083] In some embodiments, raw pressure data from the fluid management system 10 can be received from the pressure sensor 67 within the fluid warming system 60. In other embodiments, the raw pressure data can be retrieved from a database of pressures expected according to fluid flow rate. 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 about 100 milliliters per minute (mL / min). However, it is to be 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. The raw pressure data and the pressure data from the medical device 20 can be filtered using a mathematical mean to compare the raw pressure data from the fluid management system 10 with the pressure data from the medical device 20. 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 cut-off frequency. The filter cut-off 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 implemented on the filtered and normalized pressure data to extract the dominant tones 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. When the filtered and normalized pressure data is converted to the frequency domain, the dominant tone (e.g., the frequency having the maximum vibration intensity) of the fluid management system 10 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 the same or similar at 2.3 Hertz (Hz). In the illustrated example, the fluid management system 10 can determine whether the dominant tones match. If these dominant tones are equal, approximately equal, or within a predetermined range of each other, the dominant tones can be considered to match.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, is connected to the fluid management system 10, and that the pressure data from the medical device 20 can be used to control the fluid management system 10.

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

[0085] In some embodiments, for example, 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 the same or similar. 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 about 9.5 Hz, whereas the dominant tone of the medical device may be about 4 Hz. Thus, in this example, the fluid management system 10 can determine that the dominant tones do not match and that, accordingly, the 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 related to the cardiac rhythm that can be detected by the medical device 20. The fluid management system 10 can be configured to compare the characteristics extracted from the pressure signature of the heartbeat with the characteristics extracted from the pressure data received from the pressure sensor 74 on the medical device 20. These characteristics can include frequency, amplitude, dominant tone, and the like. In one example, the fluid management system 10 can compare the heartbeat data that has been filtered, normalized, and transformed into the frequency domain with the pressure data from the medical device 20 that has also been filtered, normalized, and transformed into the frequency domain in a similar manner as described above. The heartbeat data is contemplated to be obtainable from a medical device other than the fluid management system 10 or the medical device 20. When a cardiac rhythm is detected within the pressure data collected by the medical device 20, the fluid management system 10 can make a determination that the medical device 20 is in an operating state and, thus, the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. When a cardiac rhythm cannot be detected within the pressure data collected by the medical device 20, the fluid management system 10 can make a determination that the medical device 20 is not in an operating state and 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, the contraction and relaxation of the patient's ureter or renal pelvis may generate a unique measurable pressure wave. These periodic pressure changes from the contractions can be detected using the pressure sensor 74 within the medical device 20. The fluid management system 10 can be configured to compare the characteristics extracted from the pressure signature of the ureteropelvic activity with the characteristics extracted from the pressure data received from the pressure sensor 74 on the medical device 20. These characteristics can be frequency, amplitude, dominant tone, etc. In some cases, the contractions can be detected using sensors outside of the medical device 20 or outside of the fluid management system 10 for comparison with the pressure data from the medical device 20. In other embodiments, the fluid management system 10 can be configured to compare an expected or pre-programmed contraction pattern with the pressure data from the medical device 20. The contraction data (if obtained during a medical procedure) can be filtered, normalized, and converted to the frequency domain in a similar manner as described and then compared with the pressure data from the medical device 20 which has also been filtered, normalized, and converted to the frequency domain. When ureteropelvic activity is detected within the pressure data from the medical device 20, the fluid management system 10 can make a determination that the medical device 20 is in use and thus the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. When ureteropelvic activity cannot be detected within the pressure data from the medical device 20, the fluid management system 10 can make a determination that the medical device 20 is not in use and the pressure data from the medical device 20 should not be used to control the fluid management system 10.

[0088] Another source of pulsatile pressure may be the patient's respiration. For example, a patient's normal respiratory rhythm may produce a slow change over time in the intrarenal pressure. These slow pressure changes are measured by the pressure sensor 74 on the medical device 20 (when the medical device 20 is in use) and can be correlated with the patient's respiratory rhythm. The fluid management system 10 can be configured to compare the characteristics extracted from the pressure signature of the respiratory rhythm with the characteristics extracted from the pressure data received from the pressure sensor 74 on the medical device 20. These characteristics can include frequency, amplitude, dominant tone, etc. In the example, the fluid management system 10 can compare the respiratory data that has been filtered, normalized, and converted to the frequency domain with the pressure data from the medical device 20 that has also been filtered, normalized, and converted to the frequency domain in a similar manner as described above. The respiratory data is contemplated to be obtainable from a medical device other than the fluid management system 10 or the medical device 20. When a respiratory rhythm is detected in the pressure data from the medical device 20, the fluid management system 10 can make a determination that the medical device 20 is in use and, thus, the pressure data obtained from the medical device 20 can be used to control the fluid management system 10. When a respiratory rhythm cannot be detected in the pressure data from the medical device 20, the fluid management system 10 can make a determination 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 determine whether the medical device 20 is being used within a patient's body using pulsatile pressure. First, the controller 48 of the fluid management system 10 can initiate a device verification process. The controller 48 is contemplated to be configured to perform the device verification process at predetermined intervals (e.g., every minute, every five minutes, etc.) during the procedure. 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. In addition 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. Next, the fluid management system 10 can obtain pressure data from the medical device 20. In some cases, the controller 48 can poll the workstation 81 regarding raw pressure data over a predetermined period, 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. Next, the pressure data from the medical device 20 can be filtered, normalized, and transformed into the frequency domain. The pressure data from the medical device 20 is contemplated to be processed by the controller 48 or the workstation 81 as needed.

[0090] The fluid management system 10 can acquire pulsatile pressure data from the fluid management system 10 and / or the patient. The 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. The fluid management system 10 is considered to be configured to acquire pulsatile pressure data over a predetermined period that is the same as (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 instead may refer to a predetermined baseline or predicted data. The pressure data from the fluid management system 10 and / or the patient can be filtered, normalized, and converted to the frequency domain. The pressure data from the fluid management system 10 and / or the patient is considered to be processable by the controller 48 or the workstation 81 as needed.

[0091] Next, the controller 48 or the workstation 81 can compare the frequency domain data of the medical device 20 with the frequency domain data of the pulsatile pressure source. Further, the controller 48 or the workstation 81 can determine whether the frequency domain data of the medical device 20 and the frequency domain data of the pulsatile pressure source are compatible. When the frequency domain data of the medical device 20 and the frequency domain data of the pulsatile pressure source are compatible, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control the fluid flow from the fluid management system 10. When the frequency domain data of the medical device 20 and the frequency domain data of the pulsatile pressure source are not compatible, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control the fluid flow from the fluid management system 10.

[0092] Alternatively or in addition thereto, it can be determined whether data from the pressure sensor 74 of the medical device 20 can be used to assist in controlling the fluid management system 10 using data obtained from the temperature sensor 72 of the medical device 20. First, the controller 48 can initiate a device verification process. The controller 48 is considered to be configurable to perform the device verification process at predetermined intervals (e.g., every minute, every 5 minutes, etc.) during the procedure. 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 the 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. Next, the fluid management system 10 can obtain temperature data from the medical device 20. In some cases, the controller 48 can poll the workstation 81 regarding raw data over a predetermined period, but this is not essential. In some cases, the controller 48 can instruct the workstation 81 to obtain temperature data from the medical device 20.

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

[0094] The fluid management system 10 can be programmed using a first temperature range that can be considered approximately room temperature (e.g., 20°C ± 5°C or 23°C ± 3°C), or accurate room temperature measurements from an ambient temperature sensor provided with or otherwise communicating with the fluid management system 10 and a second temperature range that can be considered approximately body temperature (e.g., 37°C ± 1°C or 37°C ± 2°C) can be input into the fluid management system 10. These are merely examples. Other temperature ranges can be used as needed or as suitable for environmental conditions. In some cases, the second temperature range can be selected to account for procedures where the fluid management system 10 delivers fluid at a temperature higher than body temperature (e.g., when a laser is being used). In other cases, the second temperature range can be selected to account for procedures where the fluid management system 10 delivers fluid at a temperature lower than body temperature.

[0095] Instead of or in addition to this, in order to determine whether pressure data from the pressure sensor 74 of the medical device 20 can be used to assist in controlling the fluid management system 10, the pressure data obtained from the pressure sensor 74 of the medical device 20 can be compared with atmospheric pressure. First, the controller 48 can start the device verification process. The controller 48 is considered to be configured to perform the device verification process at predetermined intervals (e.g., every minute, every 5 minutes, etc.) during the procedure. 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 the fluid flow from the fluid management system 10 using pressure data from the medical device 20. In addition to or instead of this, the device verification process can be started manually. For example, a physician can start the device verification process using the touch screen interface 42. Then, while the fluid management system 10 is actively delivering fluid, the fluid management system 10 can obtain pressure data from the medical device 20. In some cases, the controller 48 can poll the workstation 81 regarding raw pressure data over a predetermined period, but this is not essential. In some cases, the controller 48 can instruct the workstation 81 to obtain pressure data from the medical device 20.

[0096] When the medical device 20 is inside 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 is considered to be higher than atmospheric pressure. Then, the controller 48 or the workstation 81 can determine whether the pressure data from the medical device 20 is higher than atmospheric pressure. When the pressure data obtained from the pressure sensor 74 on the medical device 20 is higher than atmospheric pressure, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control the fluid flow from the fluid management system 10. When 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 the fluid flow from the fluid management system 10. The average pressure measurement and / or the root mean square (RMS) DC pressure from the pressure sensor 74 are considered to be usable for comparison with atmospheric pressure.

[0097] Alternatively or in addition thereto, it can be determined whether data from the pressure sensor 74 of the elongate shaft 76 can be used to assist in controlling the fluid management system 10 using data obtained from the fiber Bragg diffraction grating optical fiber 75 at the distal end 80 of the medical device 20. For example, the fiber Bragg diffraction 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. First, the controller 48 can initiate a device verification process. The controller 48 is considered to be configurable to perform the device verification process at predetermined intervals (e.g., every minute, every 5 minutes, etc.) during the procedure. 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 the 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. Next, the fluid management system 10 can obtain stress data from the fiber Bragg diffraction grating optical fiber 75 or other stress measurement device at the distal end 80 of the elongate shaft 76 of the medical device 20. In some cases, the controller 48 can poll the workstation 81 regarding raw data over a predetermined period, but this is not essential. In some cases, the controller 48 can instruct the workstation 81 to obtain stress data from the medical device 20.

[0098] When the medical device 20 is within the body, the fiber Bragg diffraction grating optical fiber 75 is considered to be able to detect the stress within the elongated shaft 76 caused by the normal use of the medical device 20. Then, the controller 48 or the workstation 81 can determine whether stress data from the medical device 20 has been detected. If stress is detected, the fluid management system 10 determines that it can use the pressure data from the medical device 20 to control the fluid flow from the fluid management system 10. If no stress is detected, the fluid management system 10 determines that it cannot or should not use the pressure data from the medical device 20 to control the fluid flow from the fluid management system 10. In some cases, the stress data can be compared to a predetermined threshold. For example, when the stress exceeds a predetermined level, the medical device 20 is in a used state, whereas when the stress is at or below the predetermined level, the medical device 20 is not in a used state.

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

[0100] A position sensor (e.g., electromagnetic sensor 93, etc.) or other antenna can be incorporated into the distal end 80 of the elongate shaft 76 of the medical device 20. The position sensor can be configured for use in sensing the location of the position sensor in the magnetic field of 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 the electromagnetic generator) can be mathematically determined. The workstation 81 and the control unit can communicate to determine the position of the position sensor relative to the patient. When the position sensor is disposed within the patient, the fluid management system 10 determines that it can use pressure data from the medical device 20 to control the fluid flow from the fluid management system 10. When the electromagnetic sensor is not disposed within the patient, the fluid management system 10 determines that it cannot or should not use pressure data from the medical device 20 to control the fluid flow from the fluid management system 10.

[0101] It is considered desirable to reduce the possibility of erroneously determining that the medical device 20 is within the body when it is actually not. For example, if the 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 the temperature is close to body temperature, thus causing a false detection. It is considered 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. The results from two or more device verification processes can be obtained substantially simultaneously (e.g., in parallel) or in sequence (e.g., one at a time) as needed. The fluid management system 10 can use any number of device verification processes in any combination as needed.

[0102] The controller 48 can compare these results and determine the number of device verification processes that have confirmed that the medical device 20 is in use, using the number of device verification processes indicating that the medical device 20 is not in use. Next, the controller 48 can determine whether most of these device verification processes confirm that the medical device 20 is in use. When most of the device verification processes confirm that the medical device 20 is in use, the fluid management system 10 determines that it can use the pressure data from the medical device 20 to control the fluid flow from the fluid management system 10. When most of the device verification processes do not confirm or fail to confirm that the medical device 20 is in use, the fluid management system 10 determines that it cannot or should not use the pressure data from the medical device 20 to control the fluid flow from the fluid management system 10.

[0103] Instead of or in addition to determining whether most of the device verification processes confirm or do not confirm that the medical device 20 is in use, the controller 48 can be configured to apply a weighted average to these results when at least one device verification process returns a different result from one or more additional device verification processes. For example, if one device verification process is considered to be more accurate than other device verification processes, it can be weighted more heavily than other device verification processes during the comparison phase. Other techniques for comparing and analyzing the results from the device verification processes can be used as needed.

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

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

[0106] The materials that can be used for the various components of the systems and their various elements disclosed in this specification can generally include those related to medical devices. For the purpose of simplification, the following discussion is about the system. However, this discussion is not limited to, but can be applied to, fluid management systems, medical devices, elongated shafts, inflow pumps, fluid heating systems, controllers, supply lines, load cells, handles, workstations, display screens, fluid sources, collection containers, and / or other elements, members, components, or devices disclosed in this specification such as these elements or components. Thus, the above relevance is not intended to limit the devices and methods described in this specification.

[0107] In some embodiments, the system and / or its components can be manufactured from metals, metal alloys, polymers (some examples are disclosed below), metal-polymer composites, ceramics, and combinations thereof, 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 ester, polyurethane (e.g., Polyurethane85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether - or ester - based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, e.g., HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., those available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® 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), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (EMS AmericanAvailable from Grilon, such as GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymer (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, their copolymers, and polymer / metal composites, etc. can be included. In some embodiments, the sheath can be compounded with liquid crystal polymer (LCP). For example, this mixture can contain up to about 6 percent LCP.

[0109] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, e.g., INCONEL® 625, UNS:N06022, e.g., HASTELLOY® C-22®, UNS:N10276, e.g., HASTELLOY® C276®, and other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, e.g., MONEL® 400, nickel VAC® 400, and NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, e.g., MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665, e.g., HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten alloys or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), platinum-enriched 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 are doped with a radiopaque material, manufactured therefrom, or some or all of them can contain other radiopaque materials. The radiopaque material is understood to be a material having the function of generating a relatively high image on a fluoroscopic screen during a medical procedure or the function of another image generation technique. This relatively high-brightness image assists the user of the system in determining the location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymeric materials filled with radiopaque fillers. In addition to this, other radiopaque marker bands and / or coils can be incorporated into the system design to achieve the same result.

[0111] In some embodiments, a degree of nuclear magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the system and / or its components or each part thereof can be manufactured from materials that do not substantially distort the image and generate substantial artifacts (i.e., gaps in the image). Some ferromagnetic materials, for example, may not be suitable because they can potentially generate artifacts in MRI images. The system or each part thereof can be manufactured from materials that can be imaged by an MRI machine. Some materials that provide these properties can include, for example, tungsten, cobalt-chromium-molybdenum alloys (such as UNS:R30003 like ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (such as UNS:R30035 like 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 (dextrorphan proline arginine chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiopep, monoclonal antibodies having a function of inhibiting smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetics (such as lidocaine, bupivacaine, and ropivacaine), anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and madani antiplatelet peptides), vasocyte growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activator factors, and translation promoters), vasocyte growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressor factors, transcriptional repressor factors, translation repressor factors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins), cholesterol-lowering drugs, vasodilators, and drugs that interfere with endogenous vascular action mechanisms.

[0113] It should be understood that the disclosure of the present invention is exemplary in many respects. Without exceeding the scope of the present invention, particularly, changes can be made to the details regarding the shape, size, and arrangement of steps. This can include the use of any of the features of an exemplary embodiment used in other embodiments as long as it is appropriate. The scope of the present invention is, of course, defined by the language in which the appended claims are expressed.

Explanation of Symbols

[0114] 20 Medical device 76 Elongated shaft 80 Distal end of the elongated shaft 82 Handle 89 Power supply

Claims

1. A fluid management and medical device system comprising a medical device and a fluid management system, wherein 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, and a handle coupled to the proximal end of the elongate shaft, and wherein the fluid management system comprises 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 disposed within the patient, the controller being configured to automatically interrupt the fluid deficit calculation when the distal end of the elongate shaft is removed from the patient, a fluid management and medical device system.

2. The fluid management and medical device system according to claim 1, wherein the controller is configured to resume the fluid deficit calculation when a signal from the one or more sensors indicates that the distal end of the elongate shaft has been reinserted into the patient.

3. The fluid management and medical device system according to claim 1 or 2, wherein the controller is configured to automatically reset the fluid deficit to zero after priming of the fluid management system.

4. The fluid management and medical device system according to claim 3, wherein the controller is configured to automatically initiate the fluid deficit calculation when a signal from the one or more sensors indicates that the distal end of the elongate shaft has been inserted into the patient.

5. The fluid management and medical device system according to any one of claims 1 to 4, wherein the fluid deficit calculation continues without interruption when the fluid source is replenished.

6. A fluid management and medical device system comprising a medical device and a fluid management system, wherein 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, and a handle coupled to the proximal end of the elongate shaft, and wherein the fluid management system comprises a fluid source operatively coupled to a supply load cell and in fluid communication with the elongate shaft, and a collection container operatively coupled to a collection load cell and in fluid communication with a collection drain, 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, comprising: The controller is in electronic communication with the supply load cell and the collection load cell; A fluid management and medical device system, wherein the controller is configured to calculate fluid loss using the rotational speed of the inflow pump together with the difference between the weight change of the fluid source and the weight change of the collection container.

7. The fluid management and medical device system according to claim 6, wherein the controller is configured to calculate the fluid loss only when the distal end of the elongate shaft is disposed within the patient.

8. The controller is configured to calculate a first fluid loss value using the flow rate of the fluid and a second fluid loss 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 according to claim 6 or 7, wherein the displayed loss value is based on a combination of the first fluid loss value and the second fluid loss value.

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

10. The fluid management and medical device system according to claim 8, wherein the flow rate of the fluid is determined using data from a flow sensor disposed between the fluid source and the treatment site.

11. The controller is configured to display the displayed loss value when the difference between the first fluid loss value and the second fluid loss value is within a predetermined range; The fluid management and medical device system according to any one of claims 8 to 10, wherein the controller is configured to display a notification when the difference between the first fluid loss value and the second fluid loss value is outside a predetermined range.

12. An automatic fluid management system, comprising: A medical device and a fluid management system; The medical device includes: 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 a proximal end of the elongated shaft wherein the fluid management system a first fluid source in fluid communication with the elongated shaft a second fluid source a collection container in fluid communication with the elongated shaft an inflow pump configured to pump fluid from the first fluid source to the treatment site a controller configured to set a total fluid deficit to zero after priming of the fluid management system wherein the controller is configured to automatically initiate calculating a first fluid deficit associated with the first fluid source when the distal end of the elongated shaft is disposed within the patient wherein the controller is configured to maintain the first fluid deficit when the first fluid source is replaced by the second fluid source in fluid communication with the elongated shaft, and the controller is configured to subsequently calculate the 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 elongated shaft is disposed within the patient, an automatic fluid management system

13. The automatic fluid management system according to claim 12, wherein the controller is configured to notify a user when the total fluid deficit reaches a preset fluid deficit limit

14. The automatic fluid management system according to claim 12 or 13, wherein the controller is configured to automatically interrupt fluid deficit calculations when the distal end of the elongated shaft is removed from the patient

15. The automatic fluid management system according to claim 14, wherein the controller is configured to automatically resume fluid deficit calculations when the distal end of the elongated shaft is reinserted into the patient

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