Method of operating a fluid management system and / or medical device with adaptive data filters

Abstract

To provide methods and systems for controlling parameters of a fluid management and medical device system.SOLUTION: An illustrative method comprises initiating a command to acquire a plurality of data signals at predetermined time intervals from a sensor of a fluid management system or a medical device. Upon acquisition, the data signals are stored in a buffer until a predetermined minimum number of data signals have been acquired. A profile is generated with the plurality of data signals. The profile may be filtered with an adaptive data filter configured to perform one or more passes over the profile. Each pass of the one or more passes of the adaptive data filter may monitor and analyze a different feature of the data signals, and the one or more passes may vary depending on one or more settings received from a sub-system of the fluid management system.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 982,384, filed Feb. 27, 2020, the disclosure of which is incorporated herein by reference.

[0002] The disclosure of the present invention relates to fluid management systems. More specifically, the disclosure of the present invention relates to systems and methods for providing configurable data filters for use with fluid management systems.

Background Art

[0003] Flexible ureteroscopy (fURS), gynecology, and other endoscopic procedures require fluid circulation for several reasons. Today's surgeons deliver fluid in a variety of 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 at which fluid is delivered from the reservoir based on data collected from a treatment device such as, but not limited to, an endoscope. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and fluid delivery systems.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0005] The disclosure of this invention relates to a system and method for providing a configurable data filter for use in conjunction with a fluid management system.

[0006] In a first exemplary embodiment, a method for controlling parameters of a fluid management and medical device system may include the steps of: initiating a command in the controller of the fluid management system to acquire multiple data signals from the fluid management system or a sensor of the medical device at predetermined time intervals; storing the data signals in a buffer until a predetermined minimum number of data signals have been acquired; generating a raw data profile using the multiple data signals based on one or more setpoints received from a subsystem of the fluid management system; filtering the raw data profile using an adaptive data filter configured to perform one or more passes on the profile to produce a filtered profile; and controlling the variables of the fluid management system based on the parameters of the filtered profile. Each of the one or more passes of the adaptive data filter can monitor and analyze different characteristics of the data signal, and the one or more passes vary depending on one or more setpoints received from the subsystem of the fluid management system.

[0007] In an alternative or in addition to any of the above embodiments, in another embodiment, the controller may be configured to omit or modify any of the one or more passes of the adaptive data filter.

[0008] In an alternative or in addition to any of the above embodiments, in another embodiment, the passage of at least one adaptive data filter may be configured to reduce or eliminate noise in the raw data profile.

[0009] In an alternative or in addition to any of the above embodiments, in another embodiment, at least one pass of the adaptive data filter may be configured to monitor and / or remove pulsations in the raw data profile.

[0010] In an alternative or in addition to any of the above embodiments, in another embodiment, at least one pass of the adaptive data filter may be configured to average each oscillation in the raw data profile.

[0011] In an alternative or in addition to any of the above embodiments, in another embodiment, the passage of at least one adaptive data filter may be configured to determine whether spikes are present in the raw data profile.

[0012] In an alternative or in addition to any of the above embodiments, in another embodiment, the adaptive data filter may be configured to receive a noise tolerance input from the subsystem.

[0013] In an alternative or in addition to any of the above embodiments, in another embodiment, the controller may be configured to automatically modify the adaptive data filter based on the noise tolerance input.

[0014] In an alternative or in addition to any of the above embodiments, in another embodiment, one or more settings provided by the subsystem may include the maximum value of the raw data profile, the minimum value of the raw data profile, the average value of the raw data profile, and / or the signal-to-noise ratio of the raw data profile.

[0015] In an alternative or in addition to any of the above embodiments, in another embodiment, the step of controlling variables of the fluid management system based on parameters of the filtered profile may include the step of controlling variables based on the maximum value of the filtered profile, the minimum value of the filtered data profile, the average value of the filtered profile, the frequency of the filtered profile, spike detection of the filtered profile, and / or inter-peak pulsation of the filtered profile.

[0016] In an alternative to or in addition to any of the above embodiments, in another embodiment, the step of controlling variables of the fluid management system based on the parameters of the filtered profile may include a step of providing a warning to the user interface of the fluid management system if the filtered profile does not fall within a predetermined range.

[0017] In an alternative to or in addition to any of the above embodiments, in another embodiment, the step of controlling a variable of the fluid management system based on the parameters of the filtered profile may include a step of providing a warning to the user interface of the fluid management system if the rate of change of the filtered profile does not fall within a predetermined range.

[0018] In an alternative or in addition to any of the above embodiments, in another embodiment, the multiple data signals may comprise multiple pressure signals.

[0019] In an alternative or in addition to any of the above embodiments, in another embodiment, the multiple data signals may comprise multiple weight signals representing the amount of fluid.

[0020] In an alternative or in addition to any of the above embodiments, in another embodiment, the multiple data signals may comprise multiple temperature signals.

[0021] In another embodiment, a method for controlling parameters of a fluid management and medical device system may include the steps of: initiating a command in the controller of the fluid management system to acquire multiple data signals from the fluid management system or a sensor of the medical device at predetermined time intervals; storing the data signals in a buffer until a predetermined minimum number of data signals have been acquired; generating a raw data profile using the multiple data signals based on one or more setpoints received from a subsystem of the fluid management system; filtering the raw data profile with adaptive data configured to generate a filtered profile by performing multiple passes on the profile configured to reduce or eliminate noise in the raw data profile, monitor and / or remove pulsations in the raw data profile, average each vibration in the raw data profile, and / or determine whether spikes are present in the raw data profile; and controlling the variables of the fluid management system based on the parameters of the filtered profile. The multiple passes may be modified and / or omitted based on one or more setpoints received from a subsystem of the fluid management system.

[0022] In another embodiment, the fluid management and medical device system can comprise a fluid management system and a medical device. The fluid management system can comprise a pump configured to pump fluid from a fluid source through the fluid management system at a certain fluid flow rate, and a processing device including a user interface, and the processing device is configured to control the pump based on a set of system operating parameters to maintain a target fluid flow rate. The medical device can comprise an elongated shaft in fluid communication with the pump of the fluid management system, and a pressure sensor disposed at the distal end of the elongated shaft. The processing device of the fluid management system can be configured to adjust the fluid flow rate based on data received from the pressure sensor of the medical device. The processing device can be configured to filter data received from the pressure sensor of the medical device using an adaptive data filter configured to perform a plurality of passes over the data to generate a filtered profile, and the plurality of passes are configured to monitor and / or remove pulsations in the data, to average each vibration in the data, and / or to determine whether spikes are present in the data, so as to reduce or eliminate noise in the data.

[0023] As an alternative to or in addition to any of the above embodiments, in another embodiment, the adaptive data filter can be configured to receive a request for filtered data from a subsystem of the fluid management system.

[0024] As an alternative to or in addition to any of the above embodiments, in another embodiment, the request can include one or more set values for generating a profile of the data.

[0025] As an alternative to or in addition to any of the above embodiments, in another embodiment, the request can include one or more set values for a certain type of filtered data.

[0026] As an alternative to or in addition to any of the above embodiments, in another embodiment, the processing device can be configured to automatically modify an adaptive data filter based on a noise tolerance input.

[0027] As an alternative to or in addition to any of the above embodiments, in another embodiment, the processing device can be configured to provide a warning to the user interface of the fluid management system when the filtered profile does not fall within a predetermined range.

[0028] As an alternative to or in addition to any of the above embodiments, in another embodiment, the processing device can be configured to provide a warning to the user interface of the fluid management system when the rate of change of the filtered profile does not fall within a predetermined range.

[0029] The above summary of some exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention.

[0030] The present invention can be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0031] [Figure 1] A schematic diagram of a selected aspect of a fluid management system. [Figure 2] A diagram showing a selected aspect of the medical device and workstation of the system of FIG. 1. [Figure 3] A diagram showing a selected aspect of the medical device of FIG. 2. [Figure 4] A schematic diagram of the medical device of FIG. 2 in its original position. [Figure 5] A partial perspective view showing a selected aspect of the heater assembly and cassette of the system of FIG. 1. [Figure 6] A diagram showing a raw data profile. [Figure 7] This is a diagram showing the raw data profile. [Figure 8] This is a diagram showing the raw data profile. [Figure 9] This is a diagram showing the raw data profile. [Figure 10] This is a flowchart illustrating how to use and perform adaptive filtering of data signals. [Figure 11] This is a flowchart illustrating a method for performing adaptive filtering of data signals. [Figure 12] This is a diagram showing the filtered data profile. [Figure 13] This is a diagram showing the filtered data profile.

[0032] The present invention accepts various modifications and alternative forms, the details of which are illustrated in the drawings and described in detail below. However, it should be understood that the intent of the present invention is not to limit the embodiments to any particular embodiment described. On the contrary, the intent of the present invention is to encompass all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. [Modes for carrying out the invention]

[0033] With respect to the terms defined below, unless otherwise provided in the claims or elsewhere in this specification, these definitions shall apply.

[0034] In this specification, all numerical values, whether specified or not, are assumed to be qualified by the term “approximately.” The term “approximately” generally means a range of numbers that a person skilled in the art would consider equivalent to (e.g., having the same function or result as) the values ​​listed. In many cases, the term “approximately” can be expressed as a number rounded to the most significant figures.

[0035] Listing a range of numbers by endpoints includes all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0036] While several appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art, as evoked by the disclosure of this invention, will understand that desirable dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0037] As used herein and in the claims, the singular forms "a," "an," and "the" include plural nouns unless the context otherwise clearly indicates. As used herein and in the claims, the term "or" generally includes "and / or" unless the context otherwise clearly indicates.

[0038] The following detailed description should be read in reference to the drawings, which number similar elements in different drawings. These detailed descriptions and drawings, which may not necessarily be to exact scale, illustrate exemplary embodiments and are not intended to limit the scope of the invention. The exemplary embodiments depicted are intended to be illustrative only. Unless otherwise explicitly stated, any selective feature of any exemplary embodiment can be incorporated into additional embodiments.

[0039] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and variations thereof can generally be determined in relation to the positioning, orientation, and / or operation of various elements of a device relative to the user / operator / manipulator. “Proximal” and “backward” indicate or mean toward or toward the user, while “distal” and “forward” indicate or mean toward or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned in an attempt to facilitate understanding of the disclosure of the present invention, but such cases will be immediately apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device.

[0040] Some fluid management systems for use in flexible ureteroscopy (fURS) procedures (e.g., ureteroscopy, percutaneous nephrolithotomy (PCNL), benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP), etc.), gynecological endoscopic procedures, and other endoscopic procedures can regulate intracavitary pressure using pressure and / or temperature data from such endoscopes or other endoscopic devices when used in conjunction with endoscopic devices such as, but not limited to, LithoVue® scope devices. Direct regulation of intracavitary pressure during medical procedures can allow the fluid management system to safely drive system pressures up to 600 mmHg to ensure there is no flow loss during the procedure when the tool is inserted into the working channel of the endoscopic device. In some procedures, blood and / or debris may be present in the body cavity, which can adversely affect image quality through the endoscopic device. To improve image quality, the body cavity can be flushed using fluid flow (e.g., irrigation) through the endoscopic device. In some procedures, the body cavity may be relatively small, and the lavage fluid may flow continuously, which can increase the intra-cavity fluid pressure and / or system pressure (e.g., fluid pressure within the fluid management system itself).

[0041] The volume of some lumens is very small, and the lavage fluid flows continuously into the lumen, which can cause high pressure within the lumen. High intra-lumen fluid pressure and / or system pressure may pose a risk to the patient under certain circumstances. In some procedures, an access sheath is used to allow outflow from the lumen and reduce pressure, but in many cases, an access sheath is not used, which can cause very high pressure within the lumen. In some cases, physicians may not have a way of knowing what the pressure inside the lumen is, and therefore tend to keep the lavage flow rate low to prevent high pressure inside the lumen, which may impair image quality and visualization. In one exemplary embodiment, it is thought that if the kidney withstands high pressure over a long period of time or with short, instantaneous bursts of high pressure, it may lead to problems such as renal pelvic venous reflux and post-procedure complications such as sepsis.

[0042] Pressure measurement and monitoring, which presuppose pressure changes, present problems regarding the reliable interpretation of data and their effects on the system. For example, pressure profiles may oscillate, leading to inconsistent readings from fluid management systems. It is further considered that pressure readings from fluid management systems may give signals with pulsation or noise. It may be desirable to generate profile interpretations of pressure data that would provide greater system reliability. Excessive pulsation in the system will reduce the system's performance and physician usefulness, so in some cases, it may be desirable for the fluid management system to further protect the system's pressure output from system pulsation. Systems and methods for providing configurable data filters for use with fluid management systems are desirable.

[0043] Figure 1 is a schematic diagram of a fluid management system 10 that can be used in endoscopic procedures such as the fURS procedure. The fluid management system 10 can be coupled to a medical device 20 that allows a fluid flow to pass through it. In some embodiments, the fluid management system 10 and / or the medical device 20 may include a pressure sensor. In some embodiments, the medical device 20 may be a LithoVue® scope device or another endoscope. In exemplary embodiments, the medical device 20 may include a temperature sensor that provides intra-cavitary temperature feedback to the fluid management system 10, a pressure sensor that provides intra-cavitary pressure feedback to the fluid management system 10, and / or a camera that provides visual feedback to the fluid management system 10. Some specific and / or additional features of the fluid management system 10 and / or medical device 20 shown in Figure 1 may not be specifically mentioned with respect to Figure 1 but are discussed below with respect to and / or other figures. Figure 1 shows such features for contextual purposes.

[0044] In short, the fluid management system 10 may include an inflow pump 50 configured to pump and / or deliver fluid from a fluid supply source 34 (e.g., a fluid bag) at a certain fluid flow rate to a medical device 20 and / or a treatment site in the patient's body. In some cases, the fluid may pass through a fluid heating system 60 before flowing into the medical device 20. Fluid flow rate, fluid pressure, fluid temperature, and / or other operating parameters may be controlled, or at least partially controlled, by a controller 48. The controller 48 may enter into electronic communication (e.g., wired or wireless) with the medical device 20, the inflow pump 50, and / or the fluid heating system 60 to supply control commands, and / or transmit or receive data between the controller 48 and these devices. For example, the controller 48 may receive data from the medical device 20, such as but not limited to pressure data and temperature data. The controller 48 may then use the data received from the medical device 20 to control the operating parameters of the inflow pump 50 and / or the fluid heating system 60.

[0045] In some embodiments, the controller 48 can be configured to operate at a target fluid flow rate in flow control mode. In some embodiments, in flow control mode, the controller 48 can be configured to maintain the target fluid flow rate by controlling the inlet pump 50 based on a set of system operating parameters while monitoring the measured pressure communicated to the controller 48 from the pressure sensor. In some embodiments, when the measured pressure reaches a preset pressure threshold, the controller 48 can be configured to automatically switch from flow control mode to a pressure priority mode in which the controller 48 automatically reduces the fluid flow rate to less than the target fluid flow rate and returns the measured pressure to or less than the preset pressure threshold. In some embodiments, the controller 48 can be configured to control the inlet pump 50 based on a set of system operating parameters to maintain a desired intra-cavity fluid pressure and / or target flow rate at the treatment site.

[0046] The fluid management system 10 further includes a fluid management unit. An exemplary fluid management unit may include one or more fluid container supports, e.g., fluid source hangers 32, each supporting one or more fluid sources 34 (e.g., one or more fluid bags). In some embodiments, the position and / or weight of the fluid sources 34 (e.g., fluid bags) can be detected using remote sensors and / or supply load cells 94 connected and / or operatively coupled to each fluid source hanger 32 and / or fluid container support. A controller 48 can electronically communicate with the supply load cells 94. The fluid source hangers 32 can accommodate fluid sources 34 of various sizes, e.g., fluid sources (e.g., fluid bags) ranging from 1 liter (L) to 5 L. It will be understood that any number of fluid sources 34 can be used. Furthermore, fluid sources 34 of any size can be used depending on the procedure. In some embodiments, the fluid management unit may be mounted on a rolling stand which may include a column 36 and / or a base 38. The base 38 may include multiple wheels to facilitate the easy movement of the fluid management unit during use. However, it will be understood that the fluid supply source 34 may be suspended from the ceiling or elsewhere, depending on clinical preference. The fluid supply source hanger 32 may extend from the support column 36 and / or the controller 48 and may include one or more hooks that can suspend one or more fluid supply sources 34. In some embodiments, the fluid used in the fluid management unit may be 0.9% saline solution. However, it will be understood that various other fluids of varying viscosities may be used, depending on the procedure.

[0047] In some embodiments, the fluid management unit may include a vacuum pump 24 and a recovery container 26 that are in fluid communication with a recovery drape 28. In some embodiments, the vacuum pump 24 may include multiple vacuum pumps. In some embodiments, the recovery container 26 may include multiple containers, canisters, and / or other receptacles that can be fluidly connected to each other and / or to the vacuum pump 24. In some embodiments, the recovery drape 28 may include multiple recovery drapes. The vacuum pump 24 may be operatively and / or electronically connected to a controller 48. In some embodiments, as shown in Figure 1, the vacuum pump 24 may be positioned adjacent to and / or near the recovery container 26. In some embodiments, the vacuum pump 24 may be located within the fluid management system 10. Other configurations are also possible. In some embodiments, the recovery container 26 may be operatively coupled to a recovery load cell 25 to detect the position and / or weight of the recovery container 26. In embodiments having multiple containers, canisters, and / or other receptacles, each container, canister, and / or other receptacle can be operationally coupled to a corresponding recovery load cell 25. The controller 48 can communicate electronically with the recovery load cell 25.

[0048] The fluid management system 10 may further include one or more user interface components, such as a touch screen interface 42. The touch screen interface 42 includes a display 44 and may include switches or knobs in addition to touch functionality. In some embodiments, the controller 48 may include the touch screen interface 42 and / or the display 44. The touch screen interface 42 allows the user to input / adjust various functions of the fluid management system 10, such as flow rate, pressure, and / or temperature. The user can also configure parameters and alarms (such as, but not limited to, in-bore pressure limits and system pressure limits), information to be displayed, and procedure modes. The touch screen interface 42 allows the 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 automatic and manual modes for various procedures. It is conceivable that other systems configured to receive user input can be used instead of or in addition to the touch screen interface 42.

[0049] As those skilled in the art will understand, the touch screen interface 42 can be configured to include selectable areas such as buttons and / or provide functions similar to physical buttons. The display 44 can be configured to show icons relating to modular systems and devices contained within the fluid management system 10. Furthermore, the display 44 can include a flow rate display. The flow rate display can be determined based on a desired threshold for the flow rate set by the user before the procedure, or a known common value, etc. In some embodiments, operating parameters can be adjusted by touching the corresponding portion of the touch screen interface 42. The touch screen interface 42 can display visual warnings and / or auditory alarms when parameters (e.g., flow rate, pressure, 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 supply source 34 and / or any other information that the user may find useful during the procedure. In some embodiments, the fluid management system 10 can also include yet another user interface component, such as an optional foot pedal 46, a heater user interface, a fluid control interface, or other devices for manually controlling various modular systems. For example, the flow rate can be manually controlled using an optional foot pedal 46. Some exemplary displays and other user interface components are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," which has been assigned to the applicant of the present invention and whose entire disclosure is incorporated herein by reference.

[0050] The touch screen interface 42 can be operationally connected to or part of the controller 48. The controller 48 can be a computer, tablet computer, or other processing device. The controller 48 can be operationally connected to one or more system components, such as an inflow pump 50, a fluid heating system 60, and a fluid loss management system. In some embodiments, these features can be integrated into a single unit. The controller 48 has and is configured to perform various functions such as calculation, control, computing, and display. The controller 48 also has the function of tracking and storing data relating to the operation of the fluid management system 10 and its components. In exemplary embodiments, the controller 48 includes wired and / or wireless network communication capabilities, such as Ethernet or Wi-Fi, which enable it to connect itself to a local area network, for example. The controller 48 can receive signals from one or more of the multiple sensors of the fluid management system 10. In some embodiments, the controller 48 can communicate with a database for the purpose of providing best treatment suggestions and maintaining patient records, which can be displayed to the user on the display 44.

[0051] The fluid management system 10 can be user-selectable between different modes based on procedures, patient characteristics, etc. For example, different modes may include, but are not limited to, a limit mode, a notification mode, etc. When a mode is selected by the user, selected system parameters such as target fluid flow rate, in-lubricated fluid pressure limit, system fluid pressure limit, fluid loss, and / or temperature are provided to and / or can be entered by the user through the touch screen interface 42 and / or display 44. Exemplary parameters for a particular mode can be predetermined and loaded onto the controller 48, for example, using software. Thus, when the user selects a procedure from the initial display on the display 44 of the touch screen interface 42, these known parameters can be loaded from the controller 48 to various components of the fluid management system 10, such as, for example, the inflow pump 50, the fluid heating system 60, the fluid loss management system, etc. The fluid management system 10 can be user-selectable between automatic and manual control. For example, in certain procedures, the user may want to manually adjust the fluid flow rate, fluid pressure, and / or other parameters. If the user selects manual control, for example, on the touch screen interface 42, the user can adjust the fluid flow rate or fluid pressure through another manual interface, for example, an optional foot pedal 46. If the user selects automatic control, the user can be prompted to select or input which medical device 20 is being used through the touch screen interface 42, so that the controller 48 can determine which data and / or parameters should be used to facilitate control of the fluid management system 10. In some embodiments, the fluid management system 10 can be configured to verify that the selected medical device 20 is actually being used.

[0052] In some embodiments, the fluid management system 10 may include visual software or image recognition and analysis software. For example, the medical device 20 may include a camera 70 (e.g., Figures 2 and 4). In some embodiments, the controller 48 may be configured to include visual software / image recognition software that can detect visual noise based on changes in brightness (e.g., light monitor), contrast, or color pictuation. If it is determined that the image supplied to the controller 48 is not sufficiently clear or sharp, the fluid management system 10 may temporarily increase the fluid flow rate or fluid pressure to flush debris from the treatment site and sharpen / clarify the image. The fluid flow rate or fluid pressure may be increased manually or automatically over a temporary period of time (e.g., a predetermined time interval) or until the field of view is deemed sufficiently clear. This temporary increase ensures that the time for increasing the fluid flow rate or fluid pressure is limited to ensure that the intracavitary pressure does not exceed a safety limit.

[0053] For example, the fluid management system 10 can recognize a red phase (sign of blood) in the cleaning fluid and signal the inflow pump 50 to increase the fluid flow rate beyond a target fluid flow rate until the blood is removed from the field of view. Alternatively, the controller 48 can provide a visual warning on the display 44 that a cloudy field of view has been detected, or an audible warning, which the user can then manually adjust the fluid flow rate. In another embodiment, in cases where a significant amount of debris is present, reflected light from the debris may substantially increase the brightness of the image. In this context, the controller 48 detects this excessive brightness and signals the inflow pump 50 to increase the fluid flow rate to wash away and / or remove the debris. When the reflected light decreases as the debris is washed away and removed from the field of view of the video system, the inflow pump 50 is controlled by the controller 48 to reduce the fluid flow rate. In some cases, a physician can generate a baseline visibility level at which they deem a fluid flow that clarifies the field of view desirable, and these parameters can be entered into the fluid management system 10 via the touchscreen interface 42 before the procedure. Once a baseline is generated, the fluid management system 10 can monitor the visual feed in response to changes in the image and automatically adjust the fluid flow rate as needed.

[0054] To regulate fluid flow rate or fluid pressure by the fluid management system 10, the fluid management unit may include one or more pressurizing devices or flow generating devices, such as an inlet pump 50. In some embodiments, the inlet pump 50 may be a peristaltic pump. In some embodiments, the inlet pump 50 may include multiple pumps or more than one pump. The inlet pump 50 may be electrically driven and may be powered from a power line power source such as a wall outlet, an external or internal energy storage device such as a disposable or rechargeable battery, and / or an internal power source. The inlet pump 50 may be operated at any desired speed sufficient to deliver fluid at a target pressure and / or target fluid flow rate, for example, from 5 mmHg to 50 mmHg. As noted herein, the inlet pump 50 may be automatically adjusted based, for example, intracavitary pressure and / or temperature readings within the treatment site and / or visual feedback from a medical device 20. The inlet pump 50 may be manually adjusted, for example, through an optional foot pedal 46, a touch screen interface 42, or a separate fluid controller. Although not explicitly shown, the fluid controller may be a separate user interface including buttons that allow the user to increase or decrease the speed and / or output of the inlet pump 50. Alternatively, the fluid controller may be integrated into the main processing device and can receive input through the touch screen interface 42. In some embodiments, the fluid management system 10 may include multiple pumps having different flow functions. In some embodiments, a flow sensor 77 (e.g., Figure 5) may be positioned before and / or after the inlet pump 50 to measure the actual fluid flow rate. The flow sensor 77 may be operationally connected to the controller 48, and data from the flow sensor 77 may be used by the controller 48 to change selected system parameters.

[0055] To provide an operating room (OR) view of any changes, the fluid flow rate and / or fluid pressure of the fluid at any given time can be displayed on the display 44. If an OR staff member notices a change in either the fluid flow rate or fluid pressure that is excessively high or excessively low, the user can manually adjust the fluid flow rate or fluid pressure to return it to a preferred level. This may occur, for example, when a physician inserts or removes a tool into or from the working channel of a medical device 20. The fluid management system 10 can monitor the fluid flow rate or fluid pressure and automatically adjust them based on preset parameters, as discussed herein. This feature can be advantageous when the fluid flow is supplied manually, for example, when an assistant injects a cleaning fluid by syringe.

[0056] In some embodiments, the fluid management system 10 can automatically adjust the fluid flow rate or fluid pressure based on the measured intra-cavitary temperature and / or measured pressure, for example, when the measured pressure reaches a preset pressure threshold. In some embodiments, the measured pressure can be the intra-cavitary pressure measured within the treatment site, and the preset pressure threshold can be the intra-cavitary pressure limit. The intra-cavitary temperature and / or intra-cavitary pressure can be measured in situ within the body using a temperature sensor 72 and / or pressure sensor 74 (e.g., Figure 2) mounted on a medical device 20 used in conjunction with the fluid management system 10. In some embodiments, the measured pressure can be the system pressure measured within the fluid management system 10, and the preset pressure threshold can be the system pressure limit. The system pressure can be measured within the fluid management system 10 using a pressure sensor 67 (e.g., Figure 5) located within the fluid management system 10. In some embodiments, the fluid management system 10 may include pressure monitoring software that can be configured by the user to automatically start, stop, and / or speed-adjust the inflow pump 50 to maintain the pressure of the fluid delivered to the treatment site within a target pressure and / or a predetermined pressure range. For example, a pressure sensor 74 may detect intracavitary pressure within the treatment site (e.g., kidney or uterus) and automatically change the fluid flow rate or fluid pressure within the fluid management system 10 based on the measured intracavitary pressure (e.g., intra-kidney or intra-uterine). If the intracavitary pressure is excessively high, the fluid management system 10 may reduce the fluid flow rate or fluid pressure, and if the intracavitary pressure is excessively low, it may increase the fluid flow rate or fluid pressure.

[0057] Figures 2 to 4 show embodiments of a medical device 20 that can be used in conjunction with the fluid management system 10. In the illustrated embodiments, the medical device 20 may be a ureteroscope, such as a LithoVue® scope. However, other medical devices, such as another endoscope, may be used in addition to or instead of the ureteroscope. The medical device 20 may be configured to deliver fluid from the fluid management system 10 to the treatment site by an elongated shaft 76 configured to access the treatment site inside the patient's body. In some embodiments, an inflow pump 50 may be in fluid communication with the elongated shaft 76. The elongated shaft 76 may include one or more working lumens or other medical devices passing through it to receive the fluid flow. The medical device 20 is connected to the fluid management system 10 through one or more supply lines 78 (e.g., tubes), as shown, for example, in Figures 1 and 4.

[0058] In some embodiments, the medical device 20 can electronically communicate with the workstation 81 through a wired connection unit 79. The workstation 81 may include, among other features, a touch panel computer 83, an interface box 85 for receiving the wired connection unit 79, a cart 87, and a power supply 89. In some embodiments, the interface box 85 may be configured to have a wired or wireless communication connection unit 91 with the controller 48 of the fluid management system 10. The touch panel computer 83 may include at least a display screen and an image processing processor. In some embodiments, the workstation 81 may be a multi-use component (e.g., used in more than one procedure), while the medical device 20 may be a single-use device, although this is not mandatory. In some embodiments, the workstation 81 may be omitted, and the medical device 20 may be electronically coupled directly with the controller 48 of the fluid management system 10.

[0059] In some embodiments, one or more supply lines 78 from the fluid management system 10 to the medical device 20 may be formed of a material that helps to dampen the peristaltic motion achieved by the inflow pump 50. In some embodiments, the supply lines 78 may be formed from small-diameter piping with a diameter less than or equal to 1 / 16 inch (1.5875 millimeters). However, it will be understood that the piping size may vary depending on the application. The supply lines 78 and / or piping may be disposable and provided in a sterile and ready-to-use condition. Different types of piping may be used for various functions within the fluid management system 10. For example, one type of piping may be used for heating and controlling the fluid flow to the medical device 20, while another type of piping may be used for cleaning within the body and / or treatment site.

[0060] As shown in Figure 2, the medical device 20 may include one or more sensors near the distal end 80 of the elongated shaft 76. For example, the medical device 20 may include a pressure sensor 74 at the distal end of the elongated shaft 76 for measuring intracavitary pressure within the treatment site. The medical device 20 may further include other sensors such as a temperature sensor 72, a fiber Bragg diffraction 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 may further include at least one camera 70 for providing a visual feed to the user on the display screen of the touch panel computer 83. In another embodiment, the medical device 20 may include two cameras 70 having different communication requirements or communication protocols so that each can convey different information to the user. When provided in this manner, the user can optionally switch between these cameras 70 through the touch screen interface 42 and / or the touch panel computer 83. Although not explicitly shown, the elongated shaft 76 may include one or more working lumens for receiving fluids and / or other medical devices.

[0061] In some embodiments, the location of the distal end 80 of the elongated shaft 76 can be tracked during use. For example, the mapping and navigation system may include an operating table (or other procedural or examination table or chair, etc.) configured to act as an electromagnetic generator for generating a magnetic field of a known geometric shape. Alternatively or in addition to this, a separate electromagnetic generator may be provided. The operating table and / or electromagnetic generator may be coupled to a control unit which may include, among other features, a processor, memory, display, and input means. A position sensor (e.g., an electromagnetic sensor 93) or other antenna may be incorporated into the distal end 80 of the elongated shaft 76 of the medical device 20. The position sensor may be configured for use in sensing the location of the position sensor within the magnetic field of the mapping and navigation system. In some embodiments, the position sensor may be electronically coupled to a workstation 81. The location of the position sensor relative to the electromagnetic field source (e.g., the operating table and / or electromagnetic generator) can be mathematically determined when the position sensor is in the magnetic field. The workstation 81 and the control unit can communicate to determine the position of the position sensor relative to the patient.

[0062] The medical device 20 includes a handle 82 coupled to the proximal end of an elongated shaft 76. The handle 82 may have a fluid flow on / off switch 84 that allows the user to control when the fluid flows through the medical device 20 into the treatment site. The handle 82 may further include other buttons 86 that perform various other functions. For example, in some embodiments, the handle 82 may include a button for controlling the fluid temperature. While this exemplary embodiment describes a ureteroscope, it will be understood that the features detailed above can be directly integrated into a cystoscope, endoscope, hysteroscope, or virtually any device having imaging capabilities. In some embodiments, the medical device 20 may 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 disclosures of which are incorporated herein by reference.

[0063] In some embodiments, the controller 48 may be configured to calculate fluid loss representing fluid lost during the procedure when the distal end 80 of the elongated shaft 76 is positioned in the patient's body, fluid loss absorbed by the patient, and / or other unknown fluid loss. In some embodiments, the controller 48 may be configured to notify the user when the total fluid loss reaches a preset fluid loss limit. In some embodiments, the controller 48 may be configured to stop the inlet pump 50 and / or vacuum pump 24 when the total fluid loss reaches a preset fluid loss limit. In some embodiments, the controller 48 may be configured to notify the user when the total amount of injected fluid reaches a preset fluid injection limit. In some embodiments, the controller 48 may be configured to stop the inlet pump 50 and / or vacuum pump 24 when the total amount of injected fluid reaches a preset fluid injection limit.

[0064] In some embodiments, the controller 48 may be configured to monitor the amount of fluid in the fluid source 34 by weight, for example, using a supply load cell 94, a scale, or other suitable means. The supply load cell 94 can use the controller 48 to determine the weight of the fluid source 34 mounted on the fluid source hanger 32 and compare the initial amount of fluid in the fluid source 34 with the current amount of fluid remaining in the fluid source 34. The reading of the supply load cell 94 can be shown to the user on the display 44. As the procedure progresses, the reading of the supply load cell 94 can be updated in real time to alert the physician how much fluid remains in the fluid source 34, and this amount can then be used to determine how much fluid has been injected into the patient. In some embodiments, the amount of fluid remaining in the fluid source 34 can be indicated. For example, when only 10% of the fluid remains in the fluid source 34, a warning can be displayed on the display 44 along with an audible signal. In some embodiments, the supply load cell 94 can be connected to the display 44 via a wireless (e.g., Wi-Fi) signal. In some embodiments, the supply load cell 94 can be connected to the display 44 through a wiring connection. If the fluid supply source 34 becomes empty during the procedure, it can be replaced with a full or unused fluid supply source 34.

[0065] Similarly, the controller 48 can be configured to monitor the amount of fluid in the recovery container 26 by weight, for example, using a recovery load cell 25, a scale, or other suitable means. The recovery load cell 25 can use the controller 48 to determine the weight of the recovery container 26 and compare the initial amount of fluid in the recovery container 26 with the current amount of fluid in the recovery container 26. The reading of the recovery load cell 25 can be shown to the user on the display 44. As the procedure progresses, the reading of the recovery load cell 25 can be updated in real time to alert the physician about how much fluid is present in the recovery container 26, and this amount can then be used to determine how much fluid has been recovered from the patient and / or the recovery drape 28. In some embodiments, the amount of fluid in the recovery container 26 can be shown. For example, when only 10% of the initial empty volume remains in the recovery container 26, a warning can be shown on the display 44 along with an audible signal. In some embodiments, the recovery load cell 25 can be connected to the display 44 via a wireless (e.g., Wi-Fi) signal. In some embodiments, the recovery load cell 25 can be connected to the display 44 through a wiring connection. If the recovery container 26 becomes full during the procedure, it can be emptied and returned to its operational state, or replaced with an empty recovery container.

[0066] In some embodiments, the fluid management system 10 may include a fluid heating system 60 for heating the fluid to be delivered to the patient, as shown in Figure 5. The fluid heating system 60 may include a heater 62 and a heater cassette 64. The heater cassette 64 may be configured to be a single-use heater cassette 64, while the heater 62 can be reused for multiple procedures. For example, the heater cassette 64 may isolate the fluid flow so that the heater 62 can be reused with minimal maintenance. The heater cassette 64 may be formed from, for example, polycarbonate or any high-temperature rated biocompatible plastic, and may be formed as a single component and / or a monolithic component or multiple components permanently joined to each other. In some embodiments, the heater cassette 64 may include a fluid inlet port 61 and a fluid outlet port 63 located on its side. The fluid inlet port 61 and the fluid outlet port 63 may each be configured to be connected to a supply line 78 of the fluid management system 10. For example, the fluid inlet port 61 can connect the fluid supply source 34 to the fluid heating system 60 (through the inlet pump 50), while the fluid outlet port 63 can connect the fluid heating system 60 to the medical device 20, with each connection being through the supply line 78.

[0067] In some embodiments, the heater cassette 64 may include internal flow paths along channels that allow fluid to flow from the fluid inlet port 61 to the fluid outlet port 63. The heater cassette 64 may include one or more flow paths. In some embodiments, the channels may pass through a susceptor 66 that can allow the fluid to be heated by induction heating. When the heater cassette 64 is coupled with the heater 62, the susceptor 66 may be configured to be located within the induction coil 68. Other fluid heating system configurations and methods may be used as needed. For example, the heater 62 may include one or more heat sources in the supply line 78, such as a platen system or series coil that uses electrical energy. Heating can be specifically designed and adapted to the flow rates required for a particular application of the fluid management system 10. Some exemplary fluid heating systems are described in U.S. Patent Application Publication No. 2018 / 0361055, entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," which has been assigned to the applicant of the present invention. The entire disclosure of this document is incorporated herein by reference.

[0068] Although not explicitly shown, the fluid heating system 60 may include a heater user interface separate from the touch screen interface 42. The heater user interface may simply be a display screen that provides a digital display of the internal temperature of the heater 62. In another embodiment, this user interface may further include temperature adjustment buttons for raising or lowering the temperature of the heater 62. In this embodiment, the heater user interface and / or display screen may show the current temperature of the heater 62, as well as the target temperature to be reached. Note that all information output from the fluid heating system 60 can be transmitted directly to the display 44 so that a heater user interface is not necessary.

[0069] The fluid heating system 60 may include one or more sensors configured to monitor the fluid flowing through it. For example, a temperature sensor 65 may be installed in the fluid heating system 60 to detect the temperature of the fluid flowing through the heater cassette 64. The temperature sensor 65 may be located at or near the fluid inlet port 61 and / or fluid outlet port 63. In some embodiments, the temperature sensor 65 may be installed to detect the temperature of the fluid flowing through the heater cassette 64 before the fluid flows into the susceptor 66 and after the fluid flows out of the susceptor 66. In some embodiments, an additional sensor may be located in the middle of the susceptor 66 to detect the progression of the temperature rise of the fluid in the heater cassette 64. The temperature sensor 65 may remotely transmit any information to the display 44, or to the heater user interface and / or its display screen, if such a display screen is provided. In another embodiment, the temperature sensor 65 may be connected to a heater user interface (if provided), in which case the heater user interface can remotely transmit desired information to the display 44. Alternatively or in addition to this, the temperature sensor 65 may be connected to and / or to a controller 48.

[0070] The heater 62 may further include a pressure sensor 67 configured to monitor system pressure, and / or a bubble sensor 69 configured to monitor the fluid flowing through the system with respect to bubbles. The heater cassette 64 may include corresponding pressure sensor interfaces 71 and 73, respectively, enabling the pressure sensor 67 and bubble sensor 69 to monitor the fluid flowing through the heater cassette 64 when it is coupled to the fluid heating system 60. The pressure sensor 67 and / or bubble sensor 69 can remotely transmit any information to the controller 48, the display 44, and / or the heater user interface and / or its display screen, if such a interface is provided. In another embodiment, the pressure sensor 67 and / or bubble sensor 69 can be wired to (if provided) the heater user interface, in which case the heater user interface can remotely transmit desired information to the display 44. Alternatively or in addition to the above, the pressure sensor 67 and / or bubble sensor 69 can be wired to and / or connected to the controller 48.

[0071] The pressure signals received from the pressure sensor 74 of the medical device 20 and / or the pressure sensor 67 in the fluid management system 10 may fluctuate considerably. In some cases, the fluctuations may be due to fluid pulses resulting from pulsation in the inflow pump 50. These pulses may vary depending on the fluid flow rate. Figures 6–9 illustrate some exemplary pressure signal profiles that may occur within the fluid management system. However, these profiles are not intended to represent all possible pressure signal profiles. Each of the different pressure signal profiles may involve unique obstacles to controlling intra-cavitary pressure and / or delivery pressure during use of the medical device 20.

[0072] Figure 6 illustrates an exemplary pressure profile 100 of slow or gradual pulsation. In this example, only a section or portion of the data can be captured when using the normal mean of the pressure signal. As a result, a mean higher or lower than the actual mean may be used as the pressure signal, depending on the second analysis data. Figure 7 illustrates an exemplary pressure profile 110 of rapid or fast pulsation. When the fluid management system 10 attempts to control the fluid flow using a rapid pulsating pressure signal, the controller 48 may track this oscillation of the pressure signal and cause further oscillations within the system 10 as it tracks unstable setpoints. Figure 8 illustrates an exemplary pressure profile 120 of rapid or fast pulsation with a long spike or pressure increase. In this example, profile 120 illustrates a clear, sustained increase 122 of the pressure signal that the controller 48 needs to identify and recognize. The duration of the pressure increase and spike 122 is important for the control of the system 10 and should not be treated as noise. Figure 9 illustrates an exemplary pressure profile 130 that does not contain pulsation but includes a clear, sustained increase in the pressure signal 132. Pressure profile 130 illustrates a high-noise signal without pulsation (e.g., many spikes and drops in the pressure signal not attributable to fluid pulsation). This noise may be caused by signal noise. In the illustrated pressure profile 130, the pressure signal has a signal-to-noise ratio (SNR) of 0.47. This type of pressure profile can indicate that the quality of the pressure signal is at an unacceptable level.

[0073] To compensate for the variability of pressure signal data, configurable or adaptive data filters can be used to perform digital signal processing (DSP) on the pressure signal data and supply profiled data to subsystems of the FMS10. Using adaptive data filters, pressure signal data can be analyzed independently of other programs or subsystems of the FMS10. Thus, the same pressure dataset can be analyzed in various forms to provide highly accurate data for specific subsystems or applications of the FMS10. Furthermore, other data signals can be analyzed using similar adaptive filters. For example, the weight of the fluid supply source 34 can be measured and used by the FMS10 to provide an output that satisfies the control logic needs of the inflow pump 50 or other subsystems.

[0074] Figure 10 shows a flowchart of method 200 for using and performing adaptive filtering of a pressure signal. Although method 200 is described in relation to a pressure signal, it should be understood that this method can be applied to other data signals used to provide input to the control logic of various components of the FMS 10. For example, the weight of the fluid supply source 34, the fluid flow rate, the fluid temperature, etc., are just some additional data signals that can be filtered or filtered using the adaptive filtering technique described herein.

[0075] The exemplary method 200 can be implemented by control logic stored in the memory of the controller 48 and / or workstation 81. The exemplary method 200 shown in Figure 10 has two starting points that converge in the middle. At the first starting point, work is initiated to request data signals to be acquired or collected at predetermined time intervals (e.g., a control command is issued), as shown in block 202. For example, pressure data signals may be requested or acquired every millisecond. This is merely an example; other frequencies or intervals for data acquisition can be used as requested or as needed. Pressure data signals may be acquired, for example, by a pressure sensor 74 mounted on the medical device 20, or by other pressure sensors as needed. In some cases, the controller 48 and / or workstation 81 may acquire data when a request is received from a physician through the user interfaces 42, 83. In other embodiments, the controller 48 and / or workstation 81 may be programmed to automatically start acquiring data signals at predetermined times or when the FMS 10 or its subsystem is started. After the data acquisition process begins, raw data signals, such as but not limited to pressure data signals, are acquired, as shown in block 204. The raw data signals are stored in a buffer, as shown in block 206. The raw data signals remain in the buffer until a predetermined minimum number of samples have been acquired. Thus, the controller 48 and / or workstation 81 continue to acquire data signals at predetermined time intervals until the filter buffer is complete (e.g., has the minimum number of data samples), as shown in block 208. Upon completion of the filter buffer, the controller 48 and / or workstation 81 can be configured to generate profiled data, as shown in block 210, using the raw data signals and settings from one or more subsystems of the FMS 10. The profiled data may be based on configuration information received from subsystems that will use this data, as will be described in more detail herein. Some exemplary profiled data are shown in Figures 6 to 9.This profiled data can be filtered or filtered using adaptive data filters, as described in more detail herein. The same dataset can be analyzed (or profiled) to provide the most accurate data for a particular subsystem. For example, more than one subsystem can utilize the pressure data signal, while each subsystem can function optimally by focusing on different aspects of the data signal.

[0076] In the second starting point, as shown in block 212, the subsystem that will use the raw data signal and / or filtered data signal includes or is configured to receive a step to program to receive user input to determine the configuration regarding how the data will be profiled. The subsystem can request data signals to be analyzed or profiled in a variety of ways. These requests may include, but are not limited to, the maximum value of the raw data, the minimum value of the raw data, the mean value of the raw data, the SNR of the raw data, the maximum value of the filtered data, the minimum value of the filtered data, the mean value of the filtered data, frequency, spike detection, inter-peak pulsation, or maximum pulsation. The subsystem passes configurations or settings to the profiling data engine, as shown in block 214. These settings are stored in the profiling data engine and used to generate profiled data. The profiled data can be used as the raw data signal or processed using an adaptive data filter, as shown in block 216.

[0077] Figure 11 shows a flowchart of method 216 for processing data signals using an adaptive data filter. This method begins with a subsystem requesting data to be profiled and filtered, as shown in block 218. As part of this request, the subsystem may provide several settings that will be incorporated into the data analysis. Exemplary method 216 can be implemented by control logic stored in the memory of controller 48 and / or workstation 81. Generally, control logic is an algorithm or filter for digital signal processing of data signal profiles. Filters can be adapted or modified when processing different signals according to inputs received from subsystems and / or based on the raw data itself. Filters can perform multiple passes on profiled data. Each pass can monitor and analyze the signal with respect to different characteristics of the signal. In some cases, certain passes can be omitted if the control logic determines they are unnecessary. Thus, filters can be adapted or modified based on the signal being analyzed and / or based on the subsystems that will utilize the data signal.

[0078] First, as shown in block 220, the control logic can determine whether denoising is required from the data signal profile. If denoising is required, the filter is adjusted based on the noise immunity or noise tolerance acceptable for a given analysis (e.g., the control logic changes the filter's setpoint). The noise immunity is intended to be provided by the subsystem requesting the data. Next, as shown in block 222, the filter removes any high-frequency spikes (e.g., vibrations) from the profiled raw data to give a smooth signal. This removal can remove any minor changes caused by noise from the raw data. Next, as shown in block 224, the filter can determine the noise count within the smoothed signal. Then, as shown in block 226, the signal-to-noise ratio (SNR) can be determined using the noise count. Once the SNR is determined or if the control logic determines that denoising is not required, the control logic can determine whether a pulsation monitor is required, as shown in block 228.

[0079] When pulsation monitoring is required, the control logic will first determine the signal frequency, as shown in block 230. For example, a filter can determine inflection points within the dataset and use them as a basis for filtering. Next, as shown in block 232, the control logic can determine the inter-peak pulsation or maximum pulsation. During this stage, the time interval between each inflection point or between the previous and subsequent inflection points at that inflection point is monitored to determine the frequency of the signal pulsation within the dataset. The filter can monitor the dataset with respect to the pulsation within the range of each inflection point and monitor for the maximum, minimum, and average inter-peak deviations. The maximum inter-peak deviation will be used to determine the system's pulsation. In some cases, a warning can be generated if the inter-peak deviation exceeds a predetermined threshold.

[0080] The control logic can then average each vibration sequentially (e.g., consecutively), as shown in block 234. This can provide a smooth value for use by the subsystem. Next, as shown in block 236, the control logic determines the maximum, minimum, and / or average values ​​of the filtered profile. These values ​​can then be used by the subsystem's control system to determine the actual pressure values ​​of the FMS 10. Even when a pulsation monitor is not required, if it is deemed unnecessary to pass the signal through any other means, the control logic is designed to be able to use the maximum, minimum, and / or average values ​​of the raw signal or the filtered signal (after passing through any filters).

[0081] Once the maximum, minimum, and / or average values ​​have been determined, or the control logic has determined that a pulsation monitor is not required, the control logic can then determine whether a spike monitor is required, as shown in block 238. If a spike monitor is required, the control logic will analyze the profiled data to determine whether spikes are present in the dataset, as shown in block 240. In some cases, the spike monitor may be performed on a subset of the dataset, and this monitor can be used to determine whether a sudden increase or decrease in pressure (or other variable) has occurred. After the control logic has determined whether a spike has occurred, or if a spike monitor is not required, the filtering process can be terminated, as shown in block 242. The filtered data profile can then be used by the subsystem that initially requested the data to control different aspects of the FMS 10. For example, in response to a sustained pressure increase, the FMS 10 can reduce the fluid flow rate. This is just one example.

[0082] The adaptive or variable filtration method described with respect to Figure 11 can be used by any subsystem to determine the nature of the received signal and provide rapid and reliable results. This can enable the FMS 10 to respond quickly and safely to changes in the system. In some cases, the SNR can provide the FMS 10 with a means to detect system faults and warn the system and / or operator that the pressure reading (or other variable) may be inaccurate and that this problem should be addressed. In one example, the adaptive filter 216 can be used to determine the SNR before initiating the procedure. This determination can help protect the FMS 10 and / or the patient from potential harm if the sensor is not functioning properly. The SNR can be used in manufacturing as a baseline check to ensure that wiring and shielding are correct.

[0083] The adaptive filter 216 can provide a means for monitoring pump operation and can be used to determine the pump's rotational speed using the signal frequency. This determination allows the system to monitor changes in the pump's performance during a procedure. Spike detection has been further designed to allow the control system to take quick action to protect the system from potential overpressure conditions.

[0084] In some cases, the adaptive filter 216 can enable the controller 48 and / or workstation 81 to monitor the input signal for out-of-bounds conditions. For example, the raw data profile and / or filtered profile can be monitored for signals that are greater than a predetermined maximum threshold or less than a predetermined minimum threshold. A raw data profile and / or filtered profile outside the predetermined range may indicate a sensor failure or malfunction, and a warning can be sent to the user interface or display 44 of the FMS 10 and / or otherwise provided to the operator of the FMS 10.

[0085] The adaptive filter 216 is further designed to allow the controller 48 and / or workstation 81 to analyze the rate of change of the input signal. For example, the raw data profile and / or filtered profile can be monitored for rates of change that are greater than a predetermined maximum threshold or less than a predetermined minimum threshold. Rates of change outside the predetermined range may indicate an unstable signal, and a warning can be sent to the user interface or display 44 of the FMS 10 and / or otherwise provided to the operator of the FMS 10.

[0086] Figure 12 shows a graph 300 including the raw data signal 302 and its corresponding filtered data signal 304. In the illustrated embodiment, the raw data signal 302 is analyzed using the average maximum value as required by the subsystem. As can be seen in the smooth line of the filtered data signal 304, the filtered data signal 304 has reduced noise compared to the raw data signal 302. Furthermore, spikes 306 in the data are visible to the FMS 10 and / or subsystem (e.g., not removed by the data filter). Figure 13 shows another graph 350 including the filtered data signal 352. In the illustrated embodiment, the adaptive filter 216 removes all noise from the signal, while the spike data remains visible to the FMS 10 and / or subsystem.

[0087] Those skilled in the art will recognize that the present invention can appear in various forms other than the specific embodiments described herein and considered. Accordingly, deviations in form and detail can be made without departing from the scope and spirit of the invention as described in the appended claims. [Explanation of Symbols]

[0088] 10 Fluid Management Systems 20 Medical Devices 32 Fluid supply source hanger 34 Fluid supply source 50 Inflow pump

Claims

1. A fluid management system and / or method for operating a medical device having an adaptive data filter, The starting step is a step in which the controller of the fluid management system initiates a command, wherein the fluid management system includes an inlet pump configured to pump fluid from a fluid supply source at a certain fluid flow rate, and a pressure sensor configured to detect pressure data, the controller is electrically communicating with the inlet pump and the pressure sensor, and the command is configured to cause the controller to acquire a plurality of data signals at predetermined time intervals from the fluid management system or the pressure sensor of a medical device operationally coupled to the fluid management system, The controller stores the data signals in a buffer until a predetermined minimum number of data signals are acquired. The controller generates a raw data profile using the plurality of data signals based on one or more setpoints received from the subsystem of the fluid management system. The filtering step is a step in which the controller filters the raw data profile using an adaptive data filter, wherein the adaptive data filter is configured to perform one or more passes through the raw data profile to generate a filtered profile. The steps include: the controller controlling the variables of the fluid management system based on the parameters of the filtered profile; Equipped with, A method characterized in that each of the one or more passes of the adaptive data filter monitors and / or analyzes different characteristics of the data signal, and the one or more passes change depending on the one or more setpoints received from the subsystem of the fluid management system.

2. The method according to claim 1, wherein the controller is configured to omit or modify any of the one or more passes of the adaptive data filter.

3. The method according to claim 1, wherein the controller is configured such that passing through at least one of the adaptive data filters reduces or eliminates noise in the raw data profile.

4. The method according to claim 1, wherein the controller is configured to monitor and / or remove pulsations in the raw data profile as passed through at least one of the adaptive data filters.

5. The method according to claim 1, wherein the controller is configured such that at least one pass through the adaptive data filter averages each oscillation in the raw data profile.

6. The method according to claim 1, wherein the controller is configured to determine whether a pass through at least one of the adaptive data filters is present in the raw data profile.

7. The method according to claim 1, wherein the controller is configured such that the adaptive data filter receives a noise tolerance input from the subsystem.

8. The method according to claim 7, wherein the controller is configured to automatically modify the adaptive data filter based on the noise tolerance input.

9. The method according to claim 1, wherein the one or more settings provided by the subsystem include the maximum value of the raw data profile, the minimum value of the raw data profile, the average value of the raw data profile, and / or the signal-to-noise ratio of the raw data profile.

10. The method according to claim 1, wherein the controller is configured to perform the steps of controlling the variables of the fluid management system based on the parameters of the filtered profile, including controlling the variables based on the maximum value of the filtered profile, the minimum value of the filtered profile, the average value of the filtered profile, the frequency of the filtered profile, spike detection of the filtered profile, and / or inter-peak pulsation of the filtered profile.

11. The method according to claim 1, wherein the controller is configured to perform the step of providing a warning to the user interface of the fluid management system if the filtered profile does not fall within a predetermined range, in the step of controlling the variables of the fluid management system based on the parameters of the filtered profile.

12. The method according to claim 1, wherein the plurality of data signals comprises a plurality of pressure signals or a plurality of weight signals representing the amount of intraluminal pressure feedback from the fluid management system or medical device.

13. The method according to claim 12, wherein the controller further performs the step of automatically reducing the fluid flow rate through the fluid management system when the amount of the intra-lumen pressure feedback exceeds a predetermined threshold.

14. A method for operating fluid management and medical device systems, The starting step is a step in which the controller of a fluid management system initiates a command, wherein the fluid management system includes an inlet pump configured to pump fluid from a fluid supply source at a certain fluid flow rate, and a pressure sensor configured to detect pressure data, the controller is electrically communicating with the inlet pump and the pressure sensor, and the command is configured to cause the controller to acquire a plurality of data signals from the fluid management system or the pressure sensor of a medical device at predetermined time intervals, The controller stores the data signals in a buffer until a predetermined minimum number of data signals are acquired. The controller generates a raw data profile using the plurality of data signals based on one or more setpoints received from the subsystem of the fluid management system. The filtering step is a step in which the controller filters the raw data profile using an adaptive data filter, wherein the adaptive data filter is configured to perform one or more passes through the raw data profile to generate a filtered profile. The steps include: the controller controlling the variables of the fluid management system based on the parameters of the filtered profile; A method characterized by comprising:

15. A fluid management system and a method for operating a medical device having an adaptive data filter, The controller of the fluid management system initiates a command, and the fluid management system includes an inlet pump configured to pump fluid from a fluid supply source at a certain fluid flow rate, and a pressure sensor configured to detect pressure data, wherein the controller communicates electrically with the inlet pump and the pressure sensor, and the command is configured to cause the controller to acquire a plurality of data signals from the pressure sensor of the medical device at predetermined time intervals, and the controller, The steps include storing the data signals in a buffer until a predetermined minimum number of data signals are acquired, A step of generating a raw data profile based on one or more setpoints received from a subsystem of the fluid management system using the plurality of data signals, The filtering step is a step of filtering the raw data profile using an adaptive data filter, wherein the adaptive data filter is configured to perform one or more passes through the raw data profile to generate a filtered profile. A step of controlling the variables of the fluid management system based on the parameters of the filtered profile, Execute, The controller is configured such that each of the one or more passes of the adaptive data filter monitors and / or analyzes different characteristics of the data signal. The method is characterized in that the controller is further configured such that when the measured pressure obtained from the pressure sensor exceeds a predetermined threshold, the adaptive data filter allows the controller to change the fluid flow rate through the fluid management system.

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