Detection of an endoscope to fluid management system

Endoscopic Inspection for Fluid Management Systems

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62/867,557, filed June 27, 2019, the entire disclosure of which is incorporated herein by reference.

technical field

[0003] The present disclosure relates to a fluid management system. More particularly, the present disclosure relates to a system and method for verifying the connectivity of a device to a fluid management system.

Background technique

[0004] Flexible ureteroscopy (fURS), gynecological and other endoscopic procedures require fluid circulation for a number of reasons. Today, surgeons deliver fluids in a variety of ways, such as by hanging a fluid bag and delivering the fluid using gravity, filling a syringe and injecting the fluid manually, or using a peristaltic pump through a fluid management system at a fixed pressure or flow rate from a reservoir The device delivers fluid. The fluid management system may adjust the flow rate and/or pressure of fluid delivered from the reservoir based on data collected from a procedural device such as, but not limited to, an endoscope. Of the known medical devices, systems and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and fluid delivery systems.

SUMMARY OF THE INVENTION

[0005] The present disclosure relates to systems and methods for verifying connectivity of a procedure device to a fluid management system.

[0006] In a first example, a fluid management and medical device system may include a fluid management system and a medical device. The fluid management system may include: a pump configured to pump fluid from a fluid supply source through the fluid management system at a fluid flow rate; and a processing device including a user interface configured to control based on a set of system operating parameters pump to maintain the target fluid flow rate. The medical device may include an elongated shaft in fluid communication with a pump of the fluid management system, a pressure sensor disposed at a distal end of the elongated shaft, and a handle coupled to the proximal 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, and the processing device of the fluid management system can be configured to adjust the fluid based on the data received from the pressure sensor of the medical device Before the flow rate, verify that the medical device is in the patient's body.

[0007] Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to correlate the pulsatile pressure generated at the pump with a pressure sensor received from the medical device data for comparison.

Alternatively or in addition to any of the above examples, in another example, the pulsatile pressure generated at the pump and the data received from the pressure sensor of the medical device may each be filtered, normalized and Convert to the frequency domain.

Alternatively or in addition to any of the above examples, in another example, when a dominant tone extracted from the frequency domain of the pulsatile pressure generated at the pump is combined with the data received from the pressure sensor When the dominant tone of the frequency domain extraction matches, the processing device of the fluid management system can determine that the medical device is in use in the patient.

[0010] Alternatively or in addition to any of the above examples, in another example, the system may also include

A temperature sensor is disposed at the distal end of the elongated shaft of the medical device.

Alternatively or in addition to any of the above examples, in another example, when the temperature measured at the temperature sensor is greater than a threshold temperature above room temperature, the processing device of the fluid management system may determine that the medical The device is in use inside the patient. In some cases, the threshold temperature may be 25°C, 28°C, 30°C, 32°C, or 35°C.

[0012] Alternatively or in addition to any of the above examples, in another example, the system may further include a stress sensor disposed at the distal end of the elongated shaft of the medical device.

Alternatively or in addition to any of the above examples, in another example, when the stress measured at the stress sensor is above a predetermined threshold, the processing device of the fluid management system may determine that the medical device is in the patient in use in vivo.

[0014] Alternatively or in addition to any of the above examples, in another example, the stress sensor may be a fiber Bragg grating fiber.

[0015] Alternatively or in addition to any of the above examples, in another example, the system may further include a position marker at the distal end of the elongated shaft of the medical device, the position marker being configured for use in Used when sensing in the magnetic field of mapping and navigation systems.

[0016] Alternatively or in addition to any of the above examples, in another example, the location of the location marker may be determined relative to the patient.

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may determine that the medical device may be in use within the patient when the location of the location marker is within the patient middle.

[0018] Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to compare the pulsatile pressure generated in the body with the data received from the pressure sensor of the medical device A comparison is made, and when the data received from the pressure sensor of the medical device matches the pulsatile pressure, the processing device of the fluid management system can determine that the medical device is in use within the patient.

[0019] Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to compare the atmospheric pressure with the pressure received from the pressure sensor of the medical device upon activation of the pump. The data are compared, and when the data received from the pressure sensor of the medical device is greater than atmospheric pressure, the processing device of the fluid management system can determine that the medical device is in use within the patient.

Alternatively or in addition to any of the above examples, in another example, the medical device may also include a workstation in electronic communication with the pressure sensor and the processing device of the fluid management system, the workstation including at least a display and a processor.

[0021] In another example, a fluid management and medical device system may include a fluid management system and a medical device. The fluid management system may include: a pump configured to pump fluid from a fluid supply source through the fluid management system at a fluid flow rate; and a processing device including a user interface configured to control based on a set of system operating parameters pump to maintain the target fluid flow rate. The medical device may include an elongated shaft in fluid communication with a pump of the fluid management system, and a pressure sensor disposed at a distal end of the elongated shaft, a handle coupled to the proximal 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, and the processing device of the fluid management system can be configured to adjust the fluid based on the data received from the pressure sensor of the medical device Before the flow rate, verify that the medical device is in the patient's body.

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to correlate the pulsatile pressure generated at the pump with a pressure sensor received from the medical device data into

The pulsatile pressure generated at the pump and the data received from the pressure sensor of the medical device can each be filtered, normalized, and converted to the frequency domain.

Alternatively or in addition to any of the above examples, in another example, when the dominant tone extracted from the frequency domain of the pulsatile pressure generated at the pump is compared with the frequency domain extracted of the data received from the pressure sensor When the dominant tones of the fluid management system match, the processing device of the fluid management system can determine that the medical device is in use in the patient.

Alternatively or in addition to any of the above examples, in another example, the system may further include a temperature sensor disposed at the distal end of the elongated shaft of the medical device, and when the temperature sensor is The processing device of the fluid management system can determine that the medical device is in use within the patient when the temperature measured at the location is above room temperature.

Alternatively or in addition to any of the above examples, in another example, the system may further include a stress sensor disposed at the distal end of the elongated shaft of the medical device, and when utilizing the stress sensor When the measured stress is above a predetermined threshold, the processing device of the fluid management system may determine that the medical device is in use within the patient.

Alternatively or in addition to any of the above examples, in another example, the medical device may also include a workstation in electronic communication with the pressure sensor and the processing device of the fluid management system, the workstation including at least a display and a processor.

[0027] Alternatively or in addition to any of the above examples, in another example, the system may further include a position marker at the distal end of the elongated shaft of the medical device, the position marker being configured for use at Mapping and navigation systems are used when sensing in the magnetic field, and the position of the position marker can be determined relative to the patient.

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may determine that the medical device is in use within the patient when the location of the location marker is within the patient .

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to compare the pulsatile pressure generated in the body with the data received from the pressure sensor of the medical device A comparison is made, and the processing device of the fluid management system can determine that the medical device is in use within the patient when the characteristics extracted from the data received from the pressure sensors of the medical device match the characteristics extracted from the pulsatile pressure.

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to compare atmospheric pressure with the pressure received from the pressure sensor of the medical device upon activation of the pump. The data are compared, and when the data received from the pressure sensor of the medical device is greater than atmospheric pressure, the processing device of the fluid management system can determine that the medical device is in use within the patient.

[0031] In another example, a fluid management and medical device system may include a fluid management system and a medical device. The fluid management system may include: a pump configured to pump fluid from a fluid supply source through the fluid management system at a fluid flow rate; and a processing device including a user interface configured to control based on a set of system operating parameters pump to maintain the target fluid flow rate. The medical device may include an elongated shaft in fluid communication with a pump of the fluid management system, a pressure sensor disposed at a distal end of the elongated shaft, and a handle coupled to the proximal 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, and the processing device of the fluid management system can be configured to adjust the fluid based on the data received from the pressure sensor of the medical device Before the flow rate, at least a first verification process and a second verification process are used to verify that the medical device is in the patient's body.

Alternatively or in addition to any of the above examples, in another example, the processing device may also be configured to use a third verification process.

[0033] Alternatively or in addition to any of the above examples, in another example, each of the first verification process, the second verification process, and the third verification process may be different.

Alternatively or in addition to any of the above examples, in another example, if a majority of the first, second and third verification procedures indicate that the medical device is in the patient, the fluid management system's The processing device may determine that the medical device is in use within the patient.

Alternatively or in addition to any of the above examples, in another example, the processing device of the fluid management system may be configured to use data from each of the first, second and third verification procedures A weighted average of the results to determine whether a medical device is in use in a patient.

In another example, a method for verifying that a medical device is in use may include: receiving a first set of data from the medical device; receiving a second set of data from a fluid management system, the second set of data being related to the first set of data. a data set of the same type of data; comparing the first data set with the second data set; and determining that the medical device is in the patient's body if the first data set and the second data set satisfy a predetermined condition.

[0037] Alternatively or in addition to any of the above examples, in another example, the first set of data may be one or more pressure readings obtained at the distal end of the medical device, and the second data The sets may be one or more pressure readings obtained at the fluid management system, and the first and second data sets may each be filtered, normalized, and converted to the frequency domain.

Alternatively or in addition to any of the above examples, in another example, when the dominant tone extracted from the frequency domain of the first data set matches the dominant tone extracted from the second data set, The first data set and the second data set may satisfy predetermined conditions.

Alternatively or in addition to any of the above examples, in another example, the first set of data may be one or more temperature readings obtained at the distal end of the medical device, and the second data set may be The set may be ambient temperature, and the first data set and the second data set may satisfy a predetermined condition when one or more temperature readings of the first data set are greater than the ambient temperature.

Alternatively or in addition to any of the above examples, in another example, the first set of data may be one or more pressures obtained at the distal end of the medical device upon activation of the fluid management system and the second data set may be atmospheric pressure, and the first data set and the second data set may satisfy a predetermined condition when one or more pressure readings of the first data set are greater than atmospheric pressure.

[0041] The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention.

Description of drawings

The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

1 is a schematic diagram of a fluid management system according to an illustrative embodiment of the present disclosure;

[0044] FIG. 2 is a side view of the medical device of the system of FIG. 1, according to an illustrative embodiment;

[0045] FIG. 3 is a top view of the medical device of FIG. 2;

[0046] FIG. 4 is a schematic diagram of the medical device of FIG. 2 in situ;

[0047] FIG. 5 is a partial perspective view of a heater assembly and a cassette of the system of FIG. 1, according to an illustrative embodiment;

6 is a schematic block diagram of the illustrative fluid management system and medical device of FIG. 1;

7A-7c are a set of illustrative graphs of pressure data from a fluid management system and a medical device;

[0050] Figures 8A-8c are another set of illustrative graphs of pressure data from a fluid management system and a medical device; [0051] Figures 9-12 are used to determine whether data from a medical device can be used to control a fluid An illustrative flow diagram of a method of managing the system;

13 is a schematic perspective view of an illustrative map survey and navigation system; and

[0053] FIG. 14 is another illustrative flow diagram of a method for determining whether data from a medical device can be used to control a fluid management system.

[0054] While the invention is amenable to various modifications and alternative forms, the details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

detailed description

[0055] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this document.

[0056] All numerical values herein are considered to be modified by the term "about" whether or not explicitly stated. The term "about" generally refers to a range of numbers that one of skill in the art considers equivalent to the recited value (ie, having the same function or result). In many instances, the term "about" may be indicated to include numbers rounded to the nearest significant digit.

The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable size ranges and/or values associated with various components, features, and/or specifications are disclosed, those skilled in the art, inspired by this disclosure, will appreciate that desired sizes, ranges, and/or Values can deviate from those explicitly disclosed.

[0059] As used in this and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

[0060] The following detailed description should be read with reference to the accompanying drawings, in which like elements in different figures are numbered the same. The detailed description and drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The depicted illustrative embodiments are intended to be exemplary only. Selected features of any illustrative embodiment may be incorporated into additional embodiments unless expressly stated to the contrary.

[0061] The terms "proximal" and "distal" as used herein are intended to refer to directions towards (proximal) and away from (distal) a user of the device.

For use in flexible ureteroscopy (fURS) procedures (e.g., ureteroscopy, percutaneous nephrolithotomy (PCNL), benign prostatic hyperplasia (BPH) etc.), some fluid management systems used in gynecological examinations and other endoscopic procedures when combined with endoscopic equipment (such as, but not limited to, use of pressure and/or temperature data from endoscopes or other endoscopic equipment) LithoVue^TMMirror device) can adjust body cavity pressure when used in combination. Direct adjustment of intraluminal pressure during a medical procedure may allow the fluid management system to safely drive system pressures up to 600mmHg to ensure no flow loss during the procedure when the tool is inserted into the working channel of the endoscopic device. However, fluid management systems may need to determine when it is safe to use endoscopic data to regulate body cavity pressure (eg, intrarenal pressure). Used to verify that the endoscopic device is connected to the stream

Systems and methods for administering systems in vivo and in use in vivo are desirable.

[0063] FIG. 1 is a schematic diagram of an illustrative fluid management system 10 that may be used in an endoscopic procedure, such as an fURS procedure. The fluid management system 10 may be coupled to a surgical device 20 that allows fluid to flow therethrough and includes a pressure sensor. An illustrative surgical device may be LithoVue^TMendoscope or other endoscope. In an illustrative embodiment, device 20 may include a temperature sensor for providing intraluminal temperature feedback to fluid management system 10, a pressure sensor for providing intraluminal pressure feedback to fluid management system 10, and/or a pressure sensor for providing intraluminal pressure feedback to fluid management system 10. The system 10 provides a camera for visual feedback.

Briefly, fluid management system 10 may include pump system 50 configured to deliver fluid from fluid bag 34 to medical device 20. In some cases, fluid may pass through heating system 60 before entering medical device 20 . The flow of the fluid, the pressure of the fluid, the temperature of the fluid, and other operating parameters may be controlled, or at least partially controlled by, the main processing device 48 including the display screen 44 . Main processing device 48 may be in electronic communication (eg, wired or wireless) with medical device 20, pump system 50, and/or heating system 60 to provide control commands and/or transmit or receive data therebetween. For example, as will be described in greater detail herein, main processing system 48 may receive data from medical device 20, such as, but not limited to, pressure and temperature data. Main processing system 48 may then use the data received from medical device 20 to control operating parameters of pump system 50 and/or heating system 60 .

[0065] The fluid management system 10 also includes a fluid management unit 30. The illustrative fluid management unit 30 may include one or more fluid container supports, such as fluid bag hangers 32 , each of the one or more fluid container supports supporting one or more fluid bags 34 . In an embodiment, the placement of the fluid bag 34 may be detected using a remote sensor. The fluid bag hanger 32 can receive fluid bags 34 of various sizes, such as 1 liter (L) to 5L bags. It should be understood that any number of fluid containers may be used. Also, depending on the procedure, any size fluid container can be used. The illustrative fluid management unit 30 may be mounted to a rolling frame, which may include a rod 36 and/or a base 38 . The base 38 may include wheels to facilitate easy movement of the fluid management unit 30 when in use. It should be understood, however, that the fluid bag 34 may also be suspended from the ceiling or other locations, depending on clinical preference. The fluid bag hanger 32 extends from the rod 36 and may include one or more hooks 40 on which one or more fluid bags 34 may be suspended. The fluid used in the fluid management unit 30 may be 0.9% saline. However, it should be understood that, depending on the program, various other fluids of different viscosities may be used.

Fluid management system 10 may also include one or more user interface components, such as touch screen interface 42. The touch screen interface 42 includes a display screen 44 and may include switches or knobs in addition to touch capabilities. The touch screen interface 42 allows the user to input/adjust various functions of the system 10, such as flow rate, pressure or temperature. The user can also configure parameters and alarms (such as, but not limited to, maximum pressure alarms), messages to be displayed, and program modes. The touch screen interface 42 allows the user to add, change or discontinue use of the various modular systems within the fluid management system 10 . The touch screen interface 42 can also be used to change the system 10 between automatic and manual modes for various programs. It is contemplated that other systems configured to receive user input may be used in place of or in addition to touch screen interface 42 .

[0067] The touch screen interface 42 may be configured to include selectable areas like buttons and/or may provide functionality similar to physical buttons, as understood by those skilled in the art. Display screen 44 may be configured to show icons related to the modular systems and devices included in fluid management system 10 . For example, the display screen 44 may provide the user with a real-time video feed of the target tissue/vessel/lumen from the scope or medical device 20 . Display screen 44 may also include a flow rate display. The flow rate indicator may be determined based on a desired flow rate threshold set by the user prior to the procedure or based on known common values, or the like. In some embodiments, the operating parameters may be adjusted by touching a corresponding portion of the touch screen interface 42 . The touch screen interface 42 may also display visual and/or audio alerts if parameters (eg, flow rate, temperature, etc.) are above or below predetermined thresholds

newspaper. The touch screen interface 42 may also be configured to display system power, the amount of fluid remaining in the fluid bag 34, and any other information that the user may find useful during the procedure. In the illustrative embodiment, fluid management system 10 may also include additional user interface components, such as foot pedal 46, heater user interface, fluid control interface, or other devices that manually control the various modular systems. For example, foot pedal 46 may be used to manually control the flow rate. Some illustrative display screens 44 and other user interface components are described in commonly assigned US Patent Publication No. 2018/0361055 entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," the disclosure of which is incorporated herein by reference.

[0068] The touch screen interface 42 may be operably connected to the main processing device 48 or a portion of the main processing device 48. The main processing device 48 may be a computer, tablet computer, or other processing device. The main processing device 48 may be operably connected to one or more system components, such as the pump system 50, the heating system 60, and the fluid deficit management system. The main processing device 48 is capable and configured to perform various functions, such as calculation, control, computation, display, and the like. The main processing device 48 is also capable of tracking and storing data related to the operation of the management system 10 and each of its components. In the illustrative embodiment, main processing device 48 includes network communication capabilities (such as Wi-Fi) through which processing device 48 may connect to, for example, a local area network. The main processing device 48 may also receive signals from the sensors of the system 10 . In an embodiment, the main processing device 48 may communicate with a database for best practice recommendations and maintenance of patient records, which may be displayed to the user on the display screen 44 .

[0069] The fluid management system 10 may be user selectable between different modes based on procedures, patient characteristics, and the like. For example, different modes may include, but are not limited to, fURS mode, BPH mode, hysteroscopy mode, cystoscopy mode, and the like. Once the mode is selected by the user, mode parameters such as flow rate, pressure, fluid deficit and temperature are provided to the user through the display. Exemplary parameters for a particular mode may be predetermined and loaded onto the main processing device 48 using, for example, software. Thus, when the user selects a program from the initial display on the touch screen interface display 44, these known parameters are loaded from the processor to various components of the fluid management system 10, such as, but not limited to, the pump system 50, the heating system 60, the fluid Insufficient management system, etc. The fluid management system 10 may also be user selectable between automatic and manual modes. For example, for some programs, the user may wish to manually adjust flow rate, pressure, or other parameters. Once the user selects the manual mode, eg, on the touch screen interface 42, the user may adjust flow rate or pressure through other manual interfaces, such as the foot pedal 46 or fluid control interface. If the user selects the automatic mode, the user may be prompted to select or enter through the touch screen interface 42 which medical device 20 is being used so that the processing device 48 may determine whether the data obtained from the medical device 20 can be used to facilitate the fluid management system System 10 control. As will be described in greater detail herein, the fluid management system 10 may be configured to verify that the selected medical device 20 is actually being used prior to using the collected data.

[0070] The main processing device 48 may be configured to include vision software/image recognition software that may detect visual noise based on changes in brightness (eg, light monitoring), contrast, or color pixelation. If the image provided to the main processing device 48 is determined to be insufficient or clear, the fluid management system 10 increases the flow rate of the fluid to flush away debris to make the image clear/clear. The flow rate is increased temporarily (eg, for a predetermined period of time) or until the field of view is deemed clear enough. This temporary increase ensures that the time for the flow rate increase is limited to ensure that the pressure does not exceed safe limits. For example, system 10 may identify a red hue (a sign of blood) in the flush and signal one or more peristaltic pumps 52 within pump assembly 50 to increase flow rate until blood is cleared from the field of view. Alternatively, the processing device 48 may provide a visual alert on the display screen 44 that a clouded field is detected, or an audible alert to the doctor or nurse that the cloudy field is detected, and the user may then manually adjust the irrigation flow rate. In another example, where there is a large amount of debris, the light reflected from the debris will brighten the image significantly. In this case, the main processing device 48 detects this excessive brightness and signals the pump system 50 to increase the flow rate to remove the debris. Once the debris is flushed out of the visual system's field of view, the reflected

The light has been reduced, and the pump system 50 controlled by the main processing device 48 reduces the flow rate. In some cases, the physician may create a baseline level of visibility at which he or she prefers to initiate a field clearing flow of fluid prior to the procedure and enter these parameters into the system 10 through the touch screen interface 42 . Once the baseline is created, the system 10 monitors the visual feed for changes in the picture and adjusts the flow rate as needed.

[0071] To regulate the flow rate of fluid through the system 10, the fluid management unit 30 may include one or more pressurized devices, such as the pump 52. The illustrative pump 52 may be a peristaltic pump. The pump 52 may be electrically driven and may receive power from a line source such as a wall outlet or an external or internal electrical storage device such as a disposable or rechargeable battery. The peristaltic pump 52 may operate at any desired speed sufficient to deliver fluid at the target pressure (eg, 5 mmHg to 50 mmHg). As previously described, the pump 52 may be automatically adjusted based on, for example, pressure and temperature readings within the patient and/or visual feedback from the medical device 20 . Pump 52 may also be manually adjusted, eg, by foot pedal 46, touch screen interface 42, or a separate fluid controller. Although not explicitly shown, the fluid controls may be a separate user interface, including buttons that allow the user to increase or decrease each individual pump 52 . Alternatively, the fluid controller may be integrated into the main processing device and receive input through the touch screen interface 42 . It should be understood that any number of pumps may be used. In embodiments, fluid management system 10 may include multiple pumps with different flow capabilities. The flow meter may be located before and/or after the pump(s) 52 .

[0072] The flow rate of the fluid at any given time is displayed on the display screen 44 to allow operating room (OR) visibility of any changes. If the operating room staff notices a change in the flow rate that is too high or too low, the user can manually adjust the flow rate back to the preferred level. This may occur, for example, when a physician inserts and removes tools into and out of the working channel of the medical device 20 . As previously discussed, the fluid management system 10 may also monitor and automatically adjust the flow rate based on previously set parameters. This feature may also be beneficial when the flow is provided manually (such as by assisted injection flushing through a syringe).

[0073] As noted above, in embodiments, the fluid management system 10 may include vision software or image recognition and analysis software. In this embodiment, the fluid management system 10 may detect whether a tool has been inserted and which tool is being used via a camera 70 positioned on the medical device 20 within the body (eg, see FIGS. 2 and 3 ). The tool may, for example, have an identifiable indicia that the vision software can see to inform the system what type of tool is being used. The fluid management system 10 may then automatically adjust the flow rate based on the tool identified by the vision software. When the tool is retracted from the working channel, the fluid management system 10 reduces the pumping rate accordingly.

[0074] Additionally or alternatively, the fluid management system 10 may automatically adjust the flow rate based on the pressure and/or temperature detected within the patient. Pressure and/or temperature may be measured online by means of tools used in conjunction with fluid management system 10 , such as temperature sensor 72 and/or pressure sensor or sensor 74 mounted on medical device 20 . The fluid management system 10 may include pressure monitoring software such that the pump 52 may be configured by the user to be automatically started, stopped, and/or speed adjusted by the fluid management system 10 to maintain the fluid pressure delivered to the surgical site at a target pressure and/or predetermined within the pressure range. For example, the endoscopic pressure sensor 74 may detect pressure within the kidney and automatically vary the flow rate within the fluid management system 10 based on the monitored intrarenal pressure. If the intrarenal pressure is too high, the fluid management system 10 will reduce the flow rate and vice versa. In an exemplary temperature control mode, fluid management system 10 may include temperature monitoring software such that heating system 60 may be controlled (eg, activated, deactivated, and thermoregulated) to maintain the temperature of fluid delivered to the surgical site at approximately the target temperature and /or within a predetermined temperature and pressure range, as will be described in further detail below. For example, temperature can be monitored in vivo or in vitro, and the flow of fluid can be varied based on the temperature feedback provided. In the illustrative embodiment, fluid management system 10 The temperature and pressure sensed within the kidney can be compared to known values and a warning is provided when the parameters are outside a predetermined safe area. Warnings may be visual or audible alerts.

[0075] In an embodiment, the fluid management system 10 may monitor the movement of a target structure (eg, a kidney stone). The fluid management system 10 can calculate the rate of movement based on the original location of the stone and its new location. If the movement exceeds a predetermined threshold, the user may be prompted to manually adjust the flow rate of the fluid management system 10 . As mentioned above, the flow rate can be manually adjusted via the foot pedal 46, the touch screen interface 42, and/or the pump connector. In an embodiment, if the fluid management system 10 is in the automatic mode, the fluid management system 10 will automatically adjust the flow of the flush as needed. This ability to control stone reflux during procedures such as lithotripsy can be very beneficial.

2 and 3 are schematic diagrams of an illustrative medical device 20 that may be used in conjunction with fluid management system 10. In the embodiment shown, the medical device 20 may be a ureteroscope, such as a LithoVue^TMmirror. However, other medical equipment, such as another endoscope, may be used in addition to or instead of the ureteroscope. Medical device 20 delivers fluid from fluid management system 10 to target tissue through elongated or mirror shaft 76 . The elongated shaft 76 may include one or more working chambers for receiving the flow of fluid or other medical devices therethrough. The medical device 20 is connected to the fluid management system 10 by one or more supply lines 78 (eg, tubes), as shown in FIG. 4 , which is the medical device 20 in fluid communication with the fluid management system 10 and positioned within a patient's body schematic diagram.

[0077] The medical device 20 may be in electronic communication with the workstation 81 via a wired connection 79. Workstation 81 may include touch panel computer 83, breakout box 85 for receiving wired connection 79, cart 87 and power supply 89, among other features. In some cases, the breakout box 85 may be configured for wired or wireless communication 91 with the host processing device 48 . The touch panel computer 83 may include at least a display screen, an image processor, and a controller. In some cases, workstation 81 may be a multipurpose assembly (eg, for more than one procedure), while medical device 20 may be a disposable device, although this is not required. In some cases, workstation 81 may be omitted, and medical device 20 may be directly coupled to main processing device 48 of the fluid management system.

[0078] The supply line(s) 78 from the fluid management system 10 to the medical device 20 may be formed of a material that helps inhibit peristalsis produced by the pump 52. As shown in FIG. 2, the medical device 20 may include a pressure transducer 74 at the distal tip of the mirror shaft 76 to measure pressure within the kidney, for example. The medical device 20 may also include other sensors, such as a temperature sensor 72 , a fiber Bragg grating fiber 75 that detects stress, and/or an antenna or electromagnetic sensor 93 . In the illustrative embodiment, the distal end 80 of the medical device 20 may also include at least one camera 70 to provide a visual feed on the display screen 44 to the user. In another embodiment, the medical device 20 may include two cameras 70 with different communication requirements or protocols, such that different information may be relayed by each camera 70 to the user. When so provided, the user can switch back and forth between cameras 70 at will through touch screen interface 42 . Although not explicitly shown, the mirror shaft 76 may include one or more working chambers for receiving fluids and/or other medical devices.

[0079] The medical device 20 includes a handle 82 coupled to the proximal end of the elongated shaft 76. The handle 82 may have a fluid flow on/off switch 84 that allows the user to control when fluid flows through the medical device 20 and into the patient. The handle 82 may also include other buttons 86 that perform various other functions. For example, in one embodiment, the mirror handle 82 may include buttons to control the temperature of the mirror or fluid. In another embodiment, the mirror handle 82 may include a laser so that the user may emit laser energy. In an illustrative embodiment, the laser may be a Lumenis or StarMed Tech laser. The laser fiber can be connected to the laser system and inserted through the working channel of the ureteroscope. The user can fire a laser so that energy comes out of the tip of the laser fiber, and the wave of energy hits the debris/stone to break it up. In an exemplary embodiment that includes a laser button on the endoscope, a communication line (eg, hardwired or wireless) between the laser system and the endoscope is maintained. It should be understood that while the exemplary embodiments describe a ureteroscope, the features detailed above can also be directly integrated into a cystoscope, hysteroscope, or virtually any image-capable device. Medical device 20 may also include a drainage port 88 that may be connected to drainage system 90 . some say

The explicit drainage system 90 is described in commonly assigned US Patent Publication No. 2018/0361055 entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," the disclosure of which is incorporated herein by reference.

Returning briefly to FIG. 1 , the fluid management system 10 may include a fluid deficit monitoring system 92 . In the illustrative embodiment, fluid deficit monitoring system 92 monitors the amount of fluid (eg, saline) in fluid bag 34 by weight. For example, a weight sensor 94 (such as a scale) is suspended from the hook portion 40 . The weight sensor 94 may also include a hook 96 from which the one or more fluid bags 34 are suspended. Weight sensor 94 determines the weight of fluid bag 34 attached to management unit 30 to compare the initial amount of fluid in fluid bag 34 to the current amount of fluid remaining in fluid bag 34 . The scale reading is shown to the user on display 44 . As the procedure progresses, the scale readings are updated in real time to alert the physician how much fluid remains in the fluid bag 34, which can then be used to determine the amount of fluid that has been infused into the patient. In the illustrative embodiment, fluid management system 10 provides the amount of time remaining before a new bag is required based on the weight of bag 34 and the rate at which bag 34 is emptied (eg, flow rate). In another embodiment, the amount of remaining fluid may be shown. When, for example, 10% of the saline remains in the bag 34, an alarm may be displayed on the display screen 44 with an audible signal. In the illustrative embodiment, weight sensor 94 may be connected to display screen 44 via a Wi-Fi signal. In another exemplary embodiment, weight sensor 94 may be connected to display screen 44 through a hardwired connection.

In another illustrative embodiment, fluid deficit monitoring system 92 may include a pressure sensor connected in-line between fluid bag 34 and device 20. In this embodiment, the pressure is determined based on the height of the fluid bag 34 . As the bag empties, the amount of head pressure decreases. When the pressure falls below a user-set threshold, an alarm is displayed on the display 44 and an audible signal is emitted. In another exemplary embodiment, the fluid deficit monitoring system 92 may be set to a specific flow rate based on an amount of time that has passed. The physician may enter the bag fluid volume into the fluid management system 10, which then calculates the amount of fluid used and the amount remaining based on the known flow rate and the amount of time the fluid management system 10 has been in use.

[0082] The fluid management system 10 may utilize small diameter pump tubing 78 to connect various components. Illustrative tubing 78 for flushing procedures may be less than or equal to 1/16 inch in diameter. However, it should be understood that the pipe size may vary based on the application. The tubing can be disposable, set sterile, and ready to use. Different types of conduits may be used for various functions within fluid management system 10 . For example, one type of tubing may be used for fluid heating and fluid flow control of device 20, while another type of tubing may be used for internal flushing.

[0083] In an illustrative embodiment, fluid management system 10 may optionally include fluid warming system 60 for heating fluid to be delivered to a patient, as shown in FIG. 5 . Fluid warming system 60 includes heater 62 and heater cartridge 64 . The cassette 64 can be configured as a disposable cassette 64, while the heater 62 can be reused for multiple procedures. For example, the cassette 64 can isolate fluid flow so that the heater 62 can be reused with minimal maintenance. Cassette 64 may be formed of, for example, polycarbonate or any high heat rated biocompatible plastic, and formed as a single piece or pieces that are permanently bonded to each other. The illustrative cassette 64 may include a fluid inlet port 61 and a fluid outlet port 63 on lateral sides of the cassette 64 . The fluid inlet and outlet ports 61 , 63 may each be configured to couple to a tube 78 of the fluid management system 10 . For example, fluid inlet port 61 may couple fluid source 34 and fluid warming system 60 (via pump 52 ), while outlet port 63 may couple fluid warming system 60 with medical device 20 via fluid conduits 78 , respectively.

In the illustrative embodiment, cassette 64 includes an internal flow path along the channel through which fluid can flow from fluid inlet 61 to fluid outlet 63. Cassette 64 may include one or more fluid paths. In some cases, the channel may pass through the base 66, which may allow the fluid to be heated by induction heating. Base 66 may be configured to be positioned within induction coil 68 when cassette 64 is coupled with heater 62 . Other heater configurations and methods can also be used as desired. For example, heater 62 may include one or more heat sources (eg, platen systems) or fluids that use electrical energy

In-line coils in supply lines. Heating can be specifically designed and tailored to the flow rates required in the specific application of the fluid management system 10 . Some illustrative heater systems 60 are described in commonly assigned US Patent Publication No. 2018/0361055 entitled "AUTOMATED FLUID MANAGEMENT SYSTEM," the disclosure of which is incorporated herein by reference.

Although not explicitly shown, fluid warming system 60 may include a heater user interface separate from touch screen interface 42 . The heater user interface may simply be a display screen that provides a numerical display of the heater's internal temperature. In another embodiment, the user interface may also include temperature adjustment buttons to increase or decrease the temperature of the heater 62 . In this embodiment, the heater display may indicate the current temperature of the heater as well as the target temperature to be reached. Note that all information output from the fluid warming system 60 can be transmitted directly to the display screen 44, so that a heater user interface is not required.

[0086] The fluid warming system 60 may include one or more sensors configured to monitor the fluid. For example, temperature sensors 65 may be installed in fluid warming system 60 such that they detect the temperature of the fluid flowing through cassette 64 . Temperature sensors 65 may be located at or near fluid inlet port 61 and fluid outlet port 63 . In an illustrative embodiment, the temperature sensors 65 may be mounted such that they detect the temperature of the fluid flowing through the cassette 64 before the fluid enters the base 66 and after the fluid leaves the base 66 . In some embodiments, additional sensors may be located in the middle portion of the base 66 so that they detect the progression of the temperature increase of the fluid in the cartridge 64 . The temperature sensors 65 can send any information to the display screen 44 remotely, or if provided, they can send information to the heater user interface display screen. In another embodiment, the temperature sensor 65 may be hardwired with the heater user interface (if provided), which can then transmit desired information to the system display screen 44 remotely. Alternatively or additionally, temperature sensor 65 may be hardwired with main processing device 48 .

[0087] The heater assembly 62 may also include a pressure sensor 67 and a bubble sensor 69. Cassette 64 may include corresponding pressure sensor interfaces 71 and bubble sensor interfaces 73 that allow sensors 67, 69 to monitor fluid flow through cassette 64 when the cassette is coupled to fluid warming system 60. The pressure sensor 67 and/or the bubble sensor 69 can send any information remotely to the display screen 44, or if provided, they can send information to the heater user interface display screen. In another embodiment, the pressure sensor 67 and/or the air bubble sensor 69 may be hardwired with a heater user interface (if provided), which can then transmit desired information to the system display screen 44 remotely. Alternatively or additionally, pressure sensor 67 and/or air bubble sensor 69 may be hardwired with main processing device 48 .

FIG. 6 is a schematic block diagram illustrating fluid management system 10 and medical device 20 . As described herein, there may be two primary connections between the fluid management system 10 and the medical device 20, including one or more mechanical connections (eg, fluid tubes 78) that fluidly couple the medical device 20 to the cassette 64 and One or more electrical or communication connections 91 (eg, Ethernet cables) to which the workstation 81 of the medical device is coupled with the main processing device 48 of the fluid management system 10 . The workstation 81 of the medical device 20 may utilize the main processing device 48 of the fluid management system 10 to transmit intrarenal pressure measurements (eg, obtained with the medical device 20 ). The main processing device 48 of the fluid management system 10 may then use this pressure data to adjust the fluid flow rate when a user-specified or predetermined pressure limit is reached.

[0089] However, during a typical stone procedure, for example, the fluid management system 10 may be connected to multiple endoscopes or other medical devices. Also, in using both the medical device 20 with the pressure sensor 74 and the fluid management system 10, the main processing device 48 and the workstation can be connected during the OR phase, and the main processing device remains connected throughout the procedure. This may mean that if the medical device 20 is connected to its workstation 81, the workstation 81 transmits pressure data to the main processing device 48 of the fluid management system 10 whether or not the medical device 20 is in use. Accordingly, the main processing device 48 of the fluid management system 10 may be configured to determine when to use the pressure data from the medical device 20 for regulating intrarenal pressure is

safe. In some cases, this may be accomplished by requiring the user to select on the touch screen interface 42 the type of mirror being used. If the physician selects a device other than medical device 20 , main processing device 48 of fluid management system 10 may ignore pressure data being sent from medical device 20 .

However, there may be situations where the doctor incorrectly selects the medical device 20 when the doctor is not actually using the medical device 20, or the doctor may forget to tell the fluid management system 10 that the medical device 20 is no longer in use and a different scope or medical device The device is now in use. If the fluid management system 10 cannot detect that a new scope or medical device is being used, the fluid management system 10 may erroneously use pressure data sent from a medical device 20 that is not in use (and therefore the pressure data is relative to the intrarenal pressure) inaccurate). As a result, this can substantially bypass the fluid management system 10 pressure limit control and allow the fluid management system 10 to drive or deliver potentially dangerous pressures. To prevent this hazard from occurring, the fluid management system 10 system may need to determine when it is safe to use the pressure data transmitted from the medical device 20 via the workstation 81 . Accordingly, it may be desirable to detect whether a sensor-enabled medical device 20 is connected to the fluid management system 10 when the only connection between the medical device 20 and the fluid management system 10 may be a physical connection using, for example, a standard Luer connector.

[0091] When medical device 20 is in use with fluid management system 10, medical device 20 may be exposed to several unique sources of pulsatile pressure, which may be measured by pressure sensor 74 at the tip of medical device 20. These pulsatile sources may be unique to the fluid management system 10 or the patient. If one or more sources of pulsation can be distinguished, the fluid management system 10 can determine that the medical device 20 is in use and therefore it is safe to limit the pressure based on pressure measurements from the medical device 20 .

[0092] A pulsating pressure source may be generated within the fluid management system 10. For example, peristaltic fluid pump 52 may generate a unique fingerprint in its pulsatile flow, which may be measured using a pressure sensor such as pressure sensor 74 on medical device 20 . The pulsatility can be a function of the pump head spokes and the revolutions per minute (RPM) of the pump head. When the medical device 20 is connected to the fluid management system 10 , this fingerprint can be measured by the medical device 20 and matched to features produced by the pump mechanism of the fluid management system 10 . When there is a match between the measured pressure pulsation flow at the pressure sensor 74 of the medical device 20 and the known characteristics of the pump 52 of the fluid management system 10, the fluid management system 10 can confirm that the medical device 20 is in use and connected to Fluid management system 10 .

FIG. 7A is an illustrative graph 100 of unfiltered raw pressure data 102 from fluid management system 10 and unfiltered raw pressure data 104 from medical device 20 . In some cases, raw pressure data 102 from fluid management system 10 may be received from pressure sensor 67 in heater system 60 . In other embodiments, the pressure data 102 may be retrieved from a database of expected pressures based on fluid flow rates. In the illustrative embodiment, data 102, 104 are collected at a moderate flow rate of approximately 100 milliliters per minute (mL/min). It should be understood, however, that the data processing steps described herein can be used for flow rates of less than 100 mL/min and greater than 100 mL/min. To compare the pressure data 102 from the fluid management system 10 and the pressure data 104 from the medical device, the data 102, 104 may be filtered using mathematical averaging. First, the DC component of each measured waveform 102, 104 may be filtered. In some cases, the data 102, 104 may be filtered with a low pass filter having a filter cutoff frequency. The filter cutoff frequency can be set according to the pump flow rate. The data 102, 104 can then be normalized. FIG. 7B is the filtered and processed data from the fluid management system 10 Graph 110 of normalized pressure data 112 and filtered and normalized data 114 from medical device 20 . Next, a fast Fourier transform (FFT) algorithm may be performed on the filtered and normalized data 112 , 114 to extract the dominant tone produced by the pump 52 . The FFT algorithm may convert the filtered and normalized data 112, 114 from the time domain to the frequency domain. Figure 7c is the filtered and normalized pressure of the fluid management system 10 in the frequency domain

Graph 120 of force data and filtered and normalized pressure data for medical device 20 . When the filtered and normalized pressure data 112, 114 are converted to the frequency domain, the dominant tone 122 of the fluid management system 10 (eg, the frequency with the greatest magnitude) and the dominant tone 124 of the medical device 20 can be identified . As seen in Figure 7c, in the illustrative embodiment, the dominant tone 122 of the fluid management system 10 and the dominant tone 124 of the medical device 20 are similar or identical at approximately 2.3 hertz (Hz). In the example shown, the fluid management system 10 may determine that the dominant tones 12, 124 match. Tones 122, 124 may be considered to match if they are equal, approximately equal, or within a predetermined range of each other. When the master tone 122 of the fluid management system 10 and the master tone 124 of the medical device 20 match, the fluid management system 10 can determine that the medical device 20 is in use and connected to the fluid management system 10, and data from the medical device 20 can be used to The fluid management system 10 is controlled.

[0094] It is contemplated that data processing may take place at the main processing device 48, the workstation 81, or a combination thereof. In some embodiments, all raw pressure data 102, 104 may be processed and analyzed at a single processing device. In other embodiments, the raw pressure data 102, 104 may be processed at separate processing devices. For example, in some cases, main processing device 48 may process (eg, filter, normalize, and/or FFT) raw pressure data 102 obtained from fluid management system 10, while workstation 81 may process (eg, filter, normalize, and/or FFT) Calculation and/or FFT) raw pressure data 104 obtained from the medical device 20 . In some cases, processed medical device data may be transmitted from workstation 81 to main processing device 48 for comparison. In other embodiments, the processed fluid management system data may be transmitted from the main processing device 48 to the workstation 81 for analysis.

[0095] Figures 8A-8c illustrate the processing of another pressure data set. FIG. 8A is an illustrative graph 150 of unfiltered raw pressure data 152 from fluid management system 10 and unfiltered raw pressure data 154 from medical device 20 . In the illustrative embodiment, data 152, 154 are collected at a relatively high flow rate of approximately 400 milliliters per minute (mL/min). It should be understood, however, that the data processing steps described herein can be used for flow rates of less than 400 mL/min and greater than 400 mL/min. To compare the pressure data 152 from the fluid management system 10 and the pressure data 154 from the medical device, the data 152, 154 may be filtered using mathematical averaging. First, the DC component of each measured waveform 152, 154 may be filtered. In some cases, the data 152, 154 may be filtered with a low pass filter having a filter cutoff frequency. The filter cutoff frequency can be set according to the pump flow rate. The data 152, 154 can then be normalized. FIG. 8B is a graph 160 of filtered and normalized pressure data 162 from fluid management system 10 and filtered and normalized pressure data 164 from medical device 20 . Next, a fast Fourier transform may be performed on the filtered and normalized pressure data 162 , 164 transform, FFT) algorithm to extract the dominant tone produced by the pump 52. An FFT algorithm may convert the filtered and normalized pressure data 162, 164 from the time domain to the frequency domain. 8c is a graph 170 of filtered and normalized pressure data for the fluid management system 10 and the filtered and normalized pressure data for the medical device 20 in the frequency domain. When the filtered and normalized pressure data 162, 164 are converted to the frequency domain, the dominant tone 172 of the fluid management system 10 (eg, the frequency with the greatest magnitude) and the dominant tone 174 of the medical device 20 may be identified . As seen in Figure 8c, in the illustrative embodiment, the master tone 172 of the fluid management system 10 and the master tone 174 of the medical device 20 are not similar or the same. For example, the dominant tone 172 of the fluid management system 10 is approximately 9.5 Hz, while the dominant tone 174 of the medical device is approximately 4 Hz. In this example, the fluid management system 10 may determine that the master tones 172 , 174 do not match, and therefore data from the medical device 20 should not be used to control the fluid management system 10 .

[0096] Another source of pulsatile stressor may be the patient's heartbeat. For example, pulsatile waves synchronized with the heartbeat can be transmitted into the renal pelvis. These pulsatile waves can generate unique pressure signatures associated with heart rhythm that can be detected by the medical device 20 . The fluid management system 10 may be configured to compare the characteristics extracted from the pressure features of the heartbeat with the characteristics extracted from the data received from the pressure sensor 74 on the medical device 20 . Characteristics can be frequency, amplitude, dominant tone, and so on. In a

In one example, the fluid management system 10 may combine heartbeat data that has been filtered, normalized, and converted to the frequency domain with the heartbeat data from the medical device 20 in a manner similar to that described with reference to FIGS. 7A-7c and 8A-8c Pressure data that has also been filtered, normalized, and converted to the frequency domain were compared. It is contemplated that heartbeat data may be obtained from medical devices other than fluid management system 10 or medical device 20 . If a heart rhythm is detected in the pressure measurements of medical device 20 , fluid management system 10 may determine that medical device 20 is in use, and thus fluid management system 10 may use data obtained from medical device 20 to control fluid management system 10 . If the heart rhythm cannot be detected in the pressure measurements of the medical device 20 , the fluid management system 10 may determine that the medical device 20 is not in use and the fluid management system 10 should not use the pressure measurements from the medical device 20 .

[0097] Another source of pulsatile stressor may be the patient's ureteropelvic activity. For example, the contraction and relaxation of a patient's ureter or renal pelvis may generate unique and measurable pressure waves. The periodicity from these contractions can be detected using the pressure sensor 74 in the medical device 20 . The fluid management system 10 may be configured to compare characteristics extracted from pressure features of ureterorenal pelvis activity with characteristics extracted from data received from the pressure sensor 74 on the medical device 20 . Characteristics can be frequency, amplitude, dominant tone, and so on. In some cases, contractions may be detected using sensors other than medical device 20 or fluid management system 10 for comparison to pressure data from medical device 20 . In other embodiments, fluid management system 10 may be configured to compare expected or preprogrammed contraction patterns to pressure data from medical device 20 . It is envisaged that the shrinkage data (if obtained during a medical procedure) may have also been filtered, normalized, and Pressure data converted to the frequency domain is filtered, normalized and converted to the frequency domain before being compared. If ureteropelvic activity is detected in the medical device 20 pressure measurements, the fluid management system 10 can determine that the medical device 20 is in use, and therefore the fluid tube The data obtained from the medical device 20 may be used by the management system 10 to control the fluid management system 10 . If ureteropelvic activity cannot be detected in the pressure measurements of medical device 20, fluid management system 10 may determine that medical device 20 is not in use and fluid management system 10 should not use pressure measurements from medical device 20.

[0098] Yet another source of pulsatile stressor may be the patient's breath. For example, a patient's normal breathing rhythm may produce slow, time-varying changes in intrarenal pressure. These slow changes in pressure can be measured by the pressure sensor 74 on the medical device 20 (while the medical device 20 is in use) and matched to the patient's breathing rhythm. Fluid management system 10 may be configured to compare characteristics extracted from the pressure features of the respiratory rhythm with characteristics extracted from data received from pressure sensor 74 on medical device 20 . Characteristics can be frequency, amplitude, dominant tone, and so on. In an example, fluid management system 10 may combine respiratory data that has been filtered, normalized, and converted to the frequency domain with respiration data from medical device 20 in a manner similar to that described with reference to FIGS. 7A-7c and 8A-8c Pressure data that has also been filtered, normalized, and converted to the frequency domain were compared. It is contemplated that respiratory data may be obtained from medical devices other than fluid management system 10 or medical device 20 . If a breathing rhythm is detected in the pressure measurements of the medical device 20 , the fluid management system 10 may determine that the medical device 20 is in use, and thus the fluid management system 10 may use the data obtained from the medical device 20 to control the fluid management system 10 . If no respiratory knots are detected in the pressure measurements of the medical device 20 law, the fluid management system 10 may determine that the medical device 20 is not in use, and the fluid management system 10 should not use the pressure measurements from the medical device 20.

[0099] FIG. 9 is an illustrative flow diagram 200 of a method for determining whether a medical device 20 is in use within a patient using pulsatile pressure. First, the main processing device 48 of the fluid management system 10 may initiate a device verification process, as represented by block 202 . It is contemplated that the main processing device 48 may be configured to perform checks at predetermined intervals during the program (eg, every minute, every five minutes, etc.). In other embodiments, the primary treatment device 48 may be configured to run whenever the fluid treatment system tries

Figures perform device validation when using pressure data from medical device 20 to control fluid flow from a fluid management system. Additionally or alternatively, device authentication may be initiated manually. For example, a physician may initiate device verification using touch screen interface 42 . The fluid management system 10 may then obtain pressure data from the medical device 20 , as represented by block 204 . In some cases, the main processing device 48 of the fluid management system 10 may poll the workstation 81 of the medical device 20 for raw data for a predetermined period of time, although this is not required. In some cases, host processing device 48 may command workstation 81 to obtain pressure data from medical device 20 . The pressure data from the medical device 20 may then be filtered, normalized, and converted to the frequency domain, as shown at block 206 . It is contemplated that pressure data from the medical device 20 may be processed at the main processing device 48 of the fluid management system 10 or at the workstation 81 of the medical device 20, as desired.

[0100] The fluid management system 10 may also obtain pulsatile pressure data from the fluid management system 10 and/or the patient, as represented by block 208. Sources of pulsatile pressure data may include, but are not limited to, pressure pulses generated by peristaltic pump 52, the patient's heartbeat, the patient's ureteropelvic activity, the patient's breathing rhythm, and the like. It is contemplated that fluid management system 10 may be configured to obtain pulsatile pressure data within the same predetermined time period (eg, substantially simultaneously) as the pressure data from medical device 20 . However, in some cases, the fluid management system 10 may not obtain new data related to the pulsatile pressure data, but rather reference predetermined baseline or expected data. Pressure data from the fluid management system 10 and/or the patient may then be filtered, normalized, and converted to the frequency domain, as shown in block 210 . It is contemplated that pressure data from the fluid management system 10 and/or the patient may be processed at the main processing device 48 of the fluid management system 10 or at the workstation 81 of the medical device 20, as desired.

[0101] The main processing device 48 or workstation 81 of the fluid management system 10 may then compare the frequency domain data of the medical device 20 to the frequency domain data of the pulsatile pressure source, as represented by block 212. The main processing device 48 or workstation 81 of the fluid management system 10 may then determine whether the frequency domain data of the medical device 20 and the frequency domain data of the pulsatile pressure source match, as represented by block 214 . If the frequency domain data of the medical device 20 and the frequency domain data of the pulsatile pressure source match, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10 , as represented by block 216 . If the frequency domain data of the medical device 20 and the frequency domain data of the pulsating pressure source do not match, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10, as shown in box 218 shown.

Alternatively or additionally, data obtained from temperature sensor 72 of medical device 20 may be used to determine whether data from pressure sensor 74 may be used to assist in controlling fluid management system 10 . 10 is an illustrative flow diagram 300 of a method for using temperature measurements from medical device 20 to determine whether medical device 20 is in use within a patient. First, the main processing device 48 of the fluid management system 10 may initiate a device verification process, as represented by block 302 . It is contemplated that the main processing device 48 may be configured to perform checks at predetermined intervals (eg, every minute, every five minutes, etc.) during the program. In other embodiments, the main processing device 48 may be configured to perform device verification each time the fluid processing system attempts to use pressure data from the medical device 20 to control fluid flow from the fluid management system 10 . Additionally or alternatively, device verification (block 302 ) may be initiated manually. For example, a physician may initiate device verification using touch screen interface 42 . The fluid management system 10 may then obtain temperature data from the medical device 20 , as represented by block 304 . In some cases, the main processing device 48 of the fluid management system 10 may poll the workstation 81 of the medical device 20 for raw data for a predetermined period of time, although this is not required. In some cases, host processing device 48 may command workstation 81 to obtain temperature data from medical device 20 .

[0103] The main processing device 48 or workstation 81 of the fluid management system 10 may then determine whether the temperature measurement from the medical device 20 is greater than room temperature (eg, greater than about 20°C to 23°C), as represented by block 306. In some cases, the fluid tube

The main processing device 48 or workstation 81 of the management system 10 may then determine whether the temperature measurement from the medical device 20 is near body temperature (eg, about 37°C). If the temperature measurement obtained from the temperature sensor 72 on the medical device 20 is greater than 20°C to 23°C (eg, room temperature) or about 37°C (eg, body temperature), the fluid management system 10 determines that the pressure data from the medical device 20 can be used for Fluid flow from the fluid management system 10 is controlled, as represented by block 308 . If the temperature measurement obtained from the temperature sensor 72 on the medical device 20 is approximately 20°C-23°C (eg, room temperature) or less than 37°C (eg, body temperature), the fluid management system 10 determines the pressure data from the medical device 20 It cannot or should not be used to control fluid flow from the fluid management system 10 , as shown in block 310 . In some cases, fluid management system 10 may be configured to determine that medical device 20 is in use any time a temperature measurement obtained at temperature sensor 72 is greater than room temperature (eg, greater than about 20°C to 23°C). The fluid management system 10 may compare the temperature measurement obtained at the temperature sensor 72 to the ambient temperature measurement of the room (accurately measured room temperature). In other cases, the fluid management system 10 may be configured such that any temperature measurement obtained at the temperature sensor is greater than 25°C, greater than 28°C, or greater than 30°C The result is above room temperature, and thus the data from the medical device 20 can be used safely.

[0104] It is contemplated that the fluid management system 10 may be programmed to have a first temperature range, which may be considered to be approximately room temperature (eg, 20°C +/- 5°C or 23°C), and a second temperature range. °C +/- 3 °C), or an accurate room temperature measurement may be input into the fluid management system 10 from an ambient temperature sensor provided with or otherwise in communication with the fluid management system, this second temperature range may be considered is the approximate body temperature (eg, 37°C +/- 1°C or 37°C +/- 2°C). These are just examples. Other temperature ranges may be used as required or suitable for ambient conditions. In some cases, a body temperature range may be selected that takes into account procedures in which fluid management system 10 delivers fluid at temperatures above body temperature (eg, when the laser is in use). In other cases, a body temperature range may be selected that takes into account procedures in which fluid management system 10 delivers fluid at sub-body temperature.

Alternatively or additionally, the data obtained from the pressure sensor 74 of the medical device 20 may be compared to atmospheric pressure to determine whether the data from the pressure sensor 74 of the medical device can be used to assist in controlling the fluid management system 10 . 11 is an illustrative flow diagram 400 of another method for using pressure measurements from medical device 20 to determine whether medical device 20 is in use within a patient. First, the main processing device 48 of the fluid management system 10 may initiate a device verification process, as represented by block 402 . It is contemplated that the main processing device 48 may be configured to perform checks at predetermined intervals (eg, every minute, every five minutes, etc.) during the program. In other embodiments, the main processing device 48 may be configured to perform device verification each time the fluid processing system attempts to use pressure data from the medical device 20 to control fluid flow from the fluid management system 10 . Additionally or alternatively, device verification (block 402 ) may be initiated manually. For example, a physician may initiate device verification using touch screen interface 42 . Fluid management system 10 may then obtain pressure data from medical device 20 while fluid management system 10 is actively delivering fluid, as shown in block 404 . In some cases, the main processing device 48 of the fluid management system 10 may poll the workstation 81 of the medical device 20 for raw data for a predetermined period of time, although this not necessary. In some cases, host processing device 48 may command workstation 81 to obtain pressure data from medical device 20 . [0106] It is contemplated that if the medical device 20 is in the body while the fluid management system 10 is delivering fluid, the pressure measured at the pressure sensor 74 of the medical device 20 will be greater than atmospheric pressure. The main processing device 48 or workstation 81 of the fluid management system 10 may then determine whether the pressure measurement from the medical device 20 is greater than atmospheric pressure, as represented by block 406 . If the pressure measurement obtained from the pressure sensor 74 on the medical device 20 is above atmospheric pressure, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control the flow of fluid from the fluid management system 10 , as represented by block 408 . If the pressure measurement 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 flow from the fluid tubing

The fluid flow of the system 10 is managed, as shown in block 410 . It is contemplated that the average pressure measurement and/or root mean square (RMS) DC pressure from pressure sensor 74 may be used for comparison to atmospheric pressure.

Alternatively or additionally, data obtained from the fiber Bragg grating fiber 75 at the distal end 80 of the medical device 20 may be used to determine whether data from the pressure sensor 74 of the medical device 20 may be used to aid in fluid control Management system 10 . For example, the fiber Bragg grating fiber 75 may detect stresses along the axis 76 of the medical device 20 that occur during normal use of the medical device 20 . 12 is an illustrative flow diagram 500 of a method for using stress measurements from medical device 20 to determine whether medical device 20 is in use within a patient. First, the main processing device 48 of the fluid management system 10 may initiate a device verification process, as represented by block 502 . It is contemplated that the main processing device 48 may be configured to perform checks at predetermined intervals (eg, every minute, every five minutes, etc.) during the program. In other embodiments, the main processing device 48 may be configured to perform device verification each time the fluid processing system attempts to use pressure data from the medical device 20 to control fluid flow from the fluid management system 10 . Additionally or alternatively, device verification (block 502 ) may be initiated manually. For example, a physician may initiate device verification using touch screen interface 42 . The fluid management system 10 may then obtain stress data at the distal end 80 of the medical device 20 from the fiber Bragg grating fiber 75 or other stress measurement device, as in block 504 shown. In some cases, the main processing device 48 of the fluid management system 10 may poll the workstation 81 of the medical device 20 for raw data for a predetermined period of time, although this is not required. In some cases, host processing device 48 may command workstation 81 to obtain stress data from medical device 20 .

[0108] It is contemplated that if the medical device 20 is inside the body, the fiber Bragg grating fiber 75 can detect stresses in the elongated shaft 76 caused by normal use of the medical device. The main processing device 48 or workstation 81 of the fluid management system 10 may then determine whether a pressure measurement from the medical device 20 is detected, as represented by block 506 . If stress is detected, fluid management system 10 determines that pressure data from medical device 20 can be used to control fluid flow from fluid management system 10 , as represented by block 508 . If no stress is detected, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10 , as represented by block 510 . In some cases, the stress measurements can be compared to predetermined thresholds. For example, if the stress is above a certain level, the medical device 20 is in use, and if the stress is at or below a certain level, the medical device 20 is not in use.

[0109] Alternatively or additionally, the position of the distal end 80 of the medical device 20 may be tracked to determine whether the medical device 20 is in use. FIG. 13 is a schematic diagram of an illustrative anatomical mapping and navigation system 600 . The mapping and navigation system 600 may include an operating table 602 (or other procedure or examination table or chair, etc.). The operating table 602 may be configured to act or function as an electromagnetic generator to generate a magnetic field of known geometry. Alternatively or additionally, the electromagnetic generator 606 may be provided separate from the operating table 602 . The operating table 602 and/or the electromagnetic generator 606 may be coupled to a control unit 604, which may include features such as a processor, memory, display, and input devices.

[0110] A position sensor 93, such as, but not limited to, 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 93 may be configured to sense the position of the position sensor in the magnetic field of the mapping and navigation system 600 . Electromagnetic sensor 93 may be coupled to workstation 81 of medical device 20 . When the electromagnetic sensor 93 is in a magnetic field, the position of the electromagnetic sensor 93 can be determined mathematically relative to a source of the electromagnetic field (eg, the operating table 602 and/or the electromagnetic generator 606). Workstation 81 and control unit 604 may communicate to determine the position of electromagnetic sensor 93 relative to the patient. When the electromagnetic sensor 93 is positioned within the patient, then the fluid management system 10 determines that pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10 . When the electromagnetic sensor is not positioned within the patient, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10 .

[0111] It may be desirable to reduce the likelihood of erroneously determining that the medical device 20 is in the body when the medical device is actually not in the body. For example, if the medical device 20 is not in the body, but the user touches the temperature sensor 72, the medical device 20 may report to the fluid management system 10 that the temperature is close to body temperature, resulting in a false detection. It is contemplated that it may be desirable to use more than one sensor or technique to determine whether medical device 20 is inside the body. 14 is an illustrative flow diagram of a method 700 for determining whether a medical device 20 is in vivo using various techniques.

[0112] First, the main processing device 48 of the fluid management system 10 may initiate a device verification process, as represented by block 702. It is contemplated that the main processing device 48 may be configured to perform checks at predetermined intervals (eg, every minute, every five minutes, etc.) during the program. In other embodiments, the main processing device 48 may be configured to perform device verification each time the fluid handling system attempts to use the pressure data from the medical device 20 to control fluid flow from the fluid management system. Additionally or alternatively, device authentication may be initiated manually. For example, a physician may initiate device verification using touch screen interface 42 . The fluid management system 10 may then obtain a result (a result indicating whether the medical device 20 is in the body) from the first verification process or technique, as represented by block 704 . Validation procedures may include, but are not limited to, using pulsatile pressure from the pump 52 of the fluid management system, pulsatile pressure from the cardiac cycle, pulsatile pressure from ureteropelvic activity, pulsatile pressure from respiratory rhythm, temperature data, barometric pressure data, stress detection , location sensing, etc. Fluid management system 10 may also obtain results (results indicative of whether medical device 20 is in vivo) from one or more additional verification processes or techniques (different from the first verification process), as represented by block 706 . It is envisaged that the results from two or more verification processes may be substantially concurrent as desired (eg, in parallel) or sequentially (eg, one after the other). The fluid management system 10 may use any number and combination of verification procedures as desired.

The main processing device 48 of the fluid management system 10 may compare the results to determine the number of verification procedures that confirm that the medical device 20 is in use and the number of verification procedures that indicate that the medical device 20 is not in use, as shown in block 708 . The main processing device 48 of the fluid management system 10 may then determine whether the majority of the verification process confirms that the medical device 20 is in use, as represented by block 710 . If the majority of the verification process confirms that the medical device 20 is in use, the fluid management system 10 determines that the pressure data from the medical device 20 can be used to control fluid flow from the fluid management system 10 , as represented by block 712 . If most of the verification procedures do not or fail to confirm that the medical device 20 is in use, the fluid management system 10 determines that the pressure data from the medical device 20 cannot or should not be used to control fluid flow from the fluid management system 10 , as shown in block 714 Show. In some cases, all verification processes may confirm that the medical device 20 is in use, while in other cases, all the verification processes may agree that the medical device 20 is not in use.

Alternatively, or in addition to determining whether most of the verification procedures confirm that the medical device 20 is in the user, when at least one verification procedure returns a different result than one or more additional verification procedures, the fluid management system 10 The main processing device 48 may be configured to apply a weighted average to the results. For example, if a verification process is deemed more accurate than other verification processes, then during the comparison step (block 708 ), more accurate verification processes may be weighted more heavily than other processes. Other techniques for comparing and analyzing results from the validation process can be used as desired.

[0115] Those skilled in the art will recognize that the present invention may be embodied in many forms other than the specific embodiments described and contemplated herein. Accordingly, changes may be made in form and detail without departing from the scope and spirit of the invention as described in the appended claims.