Systems, devices, and methods for expelling and analyzing bodily fluids and assessing health

Abstract

The present application relates to systems, devices and methods for expelling and analyzing bodily fluids and assessing health, and generally includes a drainage tube in fluid communication with at least one opening located near or at a distal end of a catheter; a pump in fluid communication with the drainage tube and configured to apply a negative pressure to the drainage tube; and a valve configured for unidirectional flow and in fluid communication with the drainage tube. The controller is configured to activate the pump to apply a negative pressure for purging the air plug from the drainage tube and to monitor urine output from the patient for a first predetermined period of time above a urine output threshold and for a second predetermined period of time below the urine output threshold. If the urine output below the urine output threshold exceeds a second predetermined period of time, the controller may determine a risk of acute kidney injury.

Description

[0001] This application is a divisional application of an application with application date of March 26, 2019, application number 201980033749.7, and invention name “Systems, devices and methods for draining and analyzing body fluids and assessing health”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application is related to International Patent Application No. PCT / US2018 / 13399 filed on January 11, 2018, International Patent Application No. PCT / US2011 / 043570 filed on July 11, 2011, International Patent Application No. PCT / US2012 / 028071 filed on March 7, 2012, International Patent Application No. PCT / US2016 / 060365 filed on November 3, 2016, and International Patent Application No. PCT / US2015 / 0527 filed on September 28, 2015. 16, International Patent Application No. PCT / US2014 / 044565 filed on June 27, 2014, International Patent Application No. PCT / US2015 / 010530 filed on January 7, 2015, and International Patent Application No. PCT / US2016 / 060365 filed on November 3, 2016, each of which is incorporated herein by reference to the same extent as if each such individual publication or patent application was specifically and individually indicated to be so incorporated by reference.

[0004] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 651,377, filed on April 2, 2018, and U.S. Provisional Application No. 62 / 756,473, filed on November 6, 2018, and U.S. Provisional Application No. 62 / 776,388, filed on December 6, 2018, and U.S. Provisional Application No. 62 / 798,365, filed on January 29, 2019, each of which is incorporated herein by reference in its entirety.

[0005] Technical field of the invention

[0006] The present invention relates to the field of medical devices, in particular devices that assist in the emptying of the bladder, measure urine output and various urine parameters (such as oxygen tension, urine conductivity and urine specific gravity), monitor renal function, analyze urine parameters including urine content - including the presence of infection - and track and / or control fluid administration. The present invention also relates to medical devices capable of sensing physiological data based on sensors incorporated into catheters adapted to reside in any of the urinary tract, gastrointestinal tract, rectal location, preperitoneum, pleural space or other body cavities.

[0007] Incorporated by Reference

[0008] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each such individual publication or patent application was specifically and individually indicated to be so incorporated by reference. Background of the Invention

[0010] It is estimated that 10% of all hospitalized and long-term care patients receive an indwelling urethral catheter. Almost all critically ill patients receive an indwelling urethral catheter, and hourly monitoring of urine output is routine in the ICU. The amount of urine produced is an indicator of fluid status and renal function. However, many sources of error can cause erroneous measurements of this important indicator.

[0011] The most commonly used device for emptying the bladder is the Foley catheter. Since its introduction, the design of a flexible tube with an anchoring sac and eyelets that allow urine to drain through a central lumen has remained largely unchanged. However, it has been found that the current design of the Foley catheter may result in a large residual volume, for example greater than 50 mL, remaining in the bladder in a supine patient. See Fallis, Wendy M., "Indwelling Foley Catheters Is the Current Design a Source of Erroneous Measurement of Urine Output?" (Critical Care Nurse 25.2 (2005): 44-51 pages). In one study, the average residual volume was 96 mL in the ICU and 136 mL in the general ward. See Garcia et al., "Traditional Foley Drainage Systems—Do They Drain the Bladder?" (J Urol. 2007 January; 177 (1): 203-7; discussion 207). Large residual volumes of urine are also commonly found in the drainage tubing connecting the Foley catheter to the drainage bag or elsewhere in the drainage system.

[0012] Residual urine in the bladder and drainage tube is the result of large bubbles (air locks) that form in the tube and prevent urine from flowing from the bladder to the drainage bag. As a result, it has become routine for nurses to manipulate the drainage tube before measuring urine output, which helps empty the tube. In the ICU, where measurements are often taken once an hour, this is a very repetitive and imprecise process. There is a need for more accurate and automated urine output measurement.

[0013] Additionally, opportunities exist in urine collection systems to measure and analyze urine parameters.

[0014] In addition to improving urine output measurement and urine parameter analysis, urine drainage catheters themselves provide untapped opportunities to monitor, collect and analyze additional patient parameters.

[0015] In addition, many types of medical devices are designed to control the treatment and / or maintenance of patients. For example, a ventilator can control the patient's breathing rate, volume and / or gas mixture, etc. An IV (intravenous injection) can deliver fluids and / or other substances, such as medications, to a patient. Other devices include those that can deliver medications or perform other actions. These types of medical devices can be strictly controlled through various settings, etc. A nurse or other practitioner can check various patient parameters and adjust the medical device settings accordingly. A controller that automatically or semi-automatically uses patient parameters to control the settings of the medical device is needed. SUMMARY OF THE INVENTION

[0017] Foley-type catheters, which are widely available, low cost, and easily placed in place by health care professionals, can be used as a tool for obtaining key diagnostic information by modifying the Foley-type catheter and / or by adding functionality to the Foley-type catheter. The technology disclosed herein provides for the delivery of highly resolved and previously unavailable diagnostic information such as can be obtained from a Foley-type catheter with intra-abdominal pressure (and other) sensing capabilities.

[0018] Additionally, the development of gas plugs has been found to significantly distort intra-abdominal pressure readings. Additionally, an unemptied bladder may also adversely affect pressure readings within the bladder. The technology disclosed herein also provides for the detection and removal of gas plugs and more complete bladder drainage in the setting of intra-abdominal pressure measurement or other settings.

[0019] The technology disclosed herein seeks to empty the bladder more efficiently, prevent gas plugs from forming in drains and clear them when they do, and improve the accuracy of measuring urine output in an automated manner. The disclosed technology also seeks to incorporate additional measurements of urine, including oxygen tension, conductivity and specific gravity, gas pressure, turbidity, infection, sediment, etc., to improve the monitoring of fluid status, renal function, and other important patient parameters.

[0020] The disclosed technology also relates to a Foley-type catheter for sensing physiological data from a patient's bladder and / or urinary tract, including, in particular, those data collected by high-fidelity pressure sensing and conversion into signals suitable for processing. In some embodiments, the pressure sensing Foley-type catheter can also be enabled to sense temperature and clinically significant analytes. Examples of physiological parameters that can be measured by the sensing Foley catheter system (time-specific measurements and trends of values ​​over time) include: urine output, respiratory rate, heart rate variability, heart rate variability, stroke volume, stroke volume variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas content, pulse transit time, lung blood volume variability, temperature, blood content, and other patient parameters.

[0021] One embodiment of a drainage assembly configured to prevent negative pressure accumulation may generally include an elongated catheter having a first end configured to be inserted into a body cavity. The catheter may have: at least one opening near or at the first end, which is in fluid communication with a catheter cavity defined by it; a drainage cavity in fluid communication with a second end of the catheter; a reservoir in fluid communication with the drainage cavity; and an exhaust mechanism in fluid communication with the drainage cavity and the positive pressure cavity. The valve may be located within the exhaust mechanism and configured to remain in a closed position until a first pressure level in the drainage cavity drops to a second pressure level, causing the valve to move to an open position. In addition, a vent may be positioned in fluid communication with the valve, wherein the exhaust mechanism is configured to prevent the vent from being wetted by fluid in the drainage cavity; and a controller in communication with the reservoir, wherein the controller is configured to determine the amount of fluid collected in the reservoir.

[0022] In another embodiment, a drainage assembly can be configured to prevent negative pressure accumulation, generally comprising an elongated catheter having a first end configured to be inserted into a body cavity, the catheter having at least one opening near or at the first end that is in fluid communication with a catheter lumen defined therethrough. The drainage lumen can be in fluid communication with a second end of the catheter, the positive pressure lumen is in fluid communication with the drainage lumen, the reservoir is in fluid communication with the drainage lumen, and an exhaust mechanism is coupled to the drainage lumen, wherein the exhaust mechanism is configured to prevent the vent from being wetted by fluid in the drainage lumen. A controller can be in communication with the reservoir, wherein the controller is configured to determine a volume of fluid collected in the reservoir, and a valve configurable between a closed position and an open position can also be included, wherein the valve moves from the closed position to the open position when a first pressure level imparted on the valve drops to a second pressure level.

[0023] Certain patient parameters that can be measured and / or determined by the disclosed techniques are affected by the medical device and / or affect the treatment of the patient by the medical device. For example, the patient's urine output, respiratory rate, heart rate, stroke volume, stroke volume variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas content, temperature, blood content, and other patient parameters may be affected by and / or affect the medical treatment. Some examples of medical treatments that can be controlled by a medical device include respiratory rate and content controlled by a ventilator, IV rate and content controlled by an IV drip controller, drug delivery controlled by a drug delivery device or IV controller, urine output controlled by a urine output pump, peritoneal fluid volume controlled by a drainage pump, and other treatments controlled by other medical devices.

[0024] One embodiment of a system for analyzing bodily fluids may generally include: an elongated catheter having an inflatable bladder located near or at a distal end of the catheter and further defining one or more openings proximate to the bladder; a vent mechanism coupled to a proximal end of the catheter, the vent mechanism configured to pass air therethrough when negative pressure is applied to the vent mechanism; a first chamber coupled to the vent mechanism and in fluid communication with the one or more openings; a second chamber in fluid communication with the bladder; a reservoir coupled to a proximal end of the first chamber and in fluid communication with the one or more openings; and a controller configured to connect to the reservoir and programmed to control pressure within the first chamber, wherein the controller is further programmed to monitor distal output of urine received from a patient in the reservoir and determine the patient's intra-abdominal pressure based in part on changes in pressure within the bladder, and wherein the controller is further configured to store patient data.

[0025] In one exemplary method for analyzing one or more bodily parameters from a patient, the method may generally include positioning an elongated catheter having an inflatable bladder located near or at a distal end of the catheter within a body cavity at least partially filled with body fluid, receiving urine through one or more openings defined along the catheter proximate to the bladder, further receiving the body fluid in a reservoir located outside the body cavity and in fluid communication with the one or more openings through a fluid cavity, exhausting air through a venting mechanism in communication with the fluid cavity when negative pressure is applied to the fluid cavity, analyzing a volume of urine received in the reservoir through a controller programmed to control negative pressure of the venting mechanism, determining an intra-abdominal pressure of the patient based in part on changes in pressure within the bladder, and storing, through the controller, one or more parameters of the patient data.

[0026] Some embodiments of the sensing Foley catheter system include a loop controller that receives one or more pieces of data related to a patient parameter and uses the information to control one or more medical devices. The loop controller can be integrated with either the device that measures the patient parameter or the medical device or with both the device that measures the patient parameter and the medical device.

[0027] A pressure measuring balloon on a catheter, such as disclosed in International Patent Application No. PCT / US14 / 44565, entitled "Sensing Foley Catheter," which is incorporated herein by reference in its entirety, is one example of a device for measuring patient parameters. Additional embodiments are disclosed herein. A sensing Foley catheter system may include a pressure measuring balloon and / or other sensors and the ability to measure urine output and content to determine patient parameters, such as urine output rate, IAP, respiratory rate, heart rate, stroke volume, tissue oxygenation, urine composition, temperature, and other patient parameters.

[0028] Other parameters that can be measured and / or determined by a sensing Foley-type catheter include urine specific gravity and pulse pressure variability. These parameters can be used to help control medical devices such as ventilators and / or infusion and / or hydration devices.

[0029] Urine specific gravity is a measure of the number and weight of solute particles in the urine. The normal range is about 1.010 to 1.030. Measurements above this may indicate dehydration or other conditions. Measurements below this may indicate fluid overload or other conditions. The measurement may be made by a sensor on a sensing Foley catheter. The measurement may indicate an increase (in the case of dehydration) or decrease (in the case of fluid overload) infusion rate for the patient. The measurement may also indicate changes in ventilation parameters or drug infusions, etc.

[0030] Pulse pressure variability can be a predictive measure of fluid responsiveness of a medical device such as a ventilator and / or a fluid infusion device. A sensing Foley catheter can record the pressure waveform, and a controller can identify the maximum and minimum pressure pulses that coincide with the respiratory cycle. The controller can calculate pulse pressure variability. Pulse pressure variability can help determine whether a given patient responds to fluid therapy. Pulse pressure variability can also be used by the controller to control therapy in a feedback loop. If pulse pressure variability is high, more fluid may be needed by the patient. If pulse pressure variability is low, less fluid may be needed.

[0031] The sensing Foley catheter system can measure cardiac activity by pressure sensing in the bladder. Because the sensing Foley catheter can measure respiratory activity as well as cardiac activity, and the frequency of the patient's respiratory rate and heart rate can be similar to each other, the patient's respiratory measurement may distort the cardiac measurement. To overcome this problem, some embodiments of the controller can pause the ventilator at the end of one or more inhalation points, and / or pause the ventilator at the end of one or more exhalation points (only a few seconds each time, such as 1 to 3 seconds, or such as 1 to 4 seconds), so that the cardiac waveform can be captured without respiratory distortion. Capturing detailed cardiac waveforms in this way allows the controller to determine the stroke volume variability (SVV) useful in the detection of sepsis and the prevention of fluid excess. As an alternative embodiment, the patient can be requested to hold his / her breath at the inhalation point and / or the exhalation point.

[0032] In another embodiment, the catheter system can generally include a catheter having at least one opening near or at a distal end of the catheter, a barb in fluid communication with the proximal end of the catheter, a drainage tube in fluid communication with the at least one opening, and a vent tube in fluid communication with the barb. A one-way valve can be positioned in line with the vent tube and at a location proximal to the barb, and a controller can be in communication with the one-way valve, wherein the controller is programmed to apply negative pressure to the drainage tube, causing the one-way valve to open and fluid to pass through the vent tube.

[0033] In another embodiment, a method for discharging fluid can generally include positioning a catheter system close to the body of a subject, the catheter system having a catheter with at least one opening near the distal end of the catheter or at the distal end, a barb communicated with the proximal fluid of the catheter, and a drainage tube communicated with at least one opening fluid. A controller communicated with a one-way valve can be activated, wherein the one-way valve is positioned to be in a line with the vent pipe and is communicated with the barb fluid, wherein the one-way valve is further positioned at a position close to the barb. Negative pressure can be applied to the drainage tube, causing the one-way valve to open and fluid to pass through the vent pipe.

[0034] In another embodiment, a system for assessing the health of a patient may generally include: a drainage tube configured to be in fluid communication with at least one opening located near or at a distal end of a catheter; a pump in fluid communication with the drainage tube and configured to apply negative pressure to the drainage tube; and a valve configured for one-way flow and in fluid communication with the drainage tube. A controller may be in communication with the pump, wherein the controller is configured to activate the pump to apply negative pressure for clearing an air plug from the drainage tube. The controller may be configured to monitor urine output from the patient within a first predetermined time period above a urine output threshold and within a second predetermined time period below the urine output threshold, and the controller may be further configured to determine a risk of acute kidney injury (AKI) if the urine output below the urine output threshold exceeds the second predetermined time period.

[0035] In another embodiment, a method for assessing the health of a patient may generally include receiving urine output from a patient via a catheter having at least one opening near or at a distal end of the catheter, applying negative pressure to a drainage tube in fluid communication with the at least one opening until the air lock is cleared from the drainage tube, monitoring the urine output by a controller for a first predetermined time period above a urine output threshold, and further monitoring the urine output for a second predetermined time period below the urine output threshold. Additionally, the method may include determining a risk of AKI if the urine output below the urine output threshold exceeds the second predetermined time period. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description set forth in illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings thereof:

[0038] Figure 1 An embodiment of a sensing Foley-type catheter is shown.

[0039] Figure 2 An example of respiration rate sensing data is shown.

[0040] Figure 3 A detailed section of the respiration distribution is shown.

[0041] Figure 4 Examples of heart rate and relative cardiac output sensor data are shown.

[0042] Figure 5 Data related to relative cardiac output sensing during a human leg raise exercise are shown.

[0043] Figure 6 An example of peritoneal sensing data is shown.

[0044] Figure 7 An example of peritoneal sensing data is shown.

[0045] Figure 8 The relationship among intra-abdominal pressure, respiratory wave pressure and cardiac pressure is shown.

[0046] Fig. 9 A flow chart of an embodiment of a method is provided.

[0047] Fig. 10A An embodiment of a sensing Foley catheter system is shown.

[0048] Fig. 10B Shows Fig. 10A Detailed view of the gas lock purge mechanism and fluid collection and analysis system.

[0049] Fig. 10C Disposable components of an embodiment of a sensing Foley catheter system are shown.

[0050] Figures 11A-11C Various embodiments of sensing Foley catheter systems are shown.

[0051] Fig.11D An embodiment of a vent tube is shown.

[0052] Fig.11E An embodiment of a catheter system is shown in which the vent lumen is in direct fluid communication with a fluid collection bag.

[0053] Fig.11F A graphical representation of a valve opening cycle is shown.

[0054] Fig. 12A Another embodiment of a sensing Foley catheter system is shown.

[0055] Fig. 12B Another embodiment of a sensing Foley catheter system is shown.

[0056] Fig.13 Another embodiment of a sensing Foley catheter system is shown.

[0057] Fig.14A and Fig. 14B An embodiment of a collapsible drain tube residing in an anti-kink tube is shown.

[0058] Fig.15 An example of a clearing mechanism for a sensing Foley catheter system is shown.

[0059] Fig.16 An example of a clearing mechanism for a sensing Foley catheter system is shown.

[0060] Fig.17An embodiment of a sensing Foley catheter system having a drainage tube with a gas sampling lumen is shown.

[0061] Fig.18 An active exhaust system with a vent and a pump is shown.

[0062] Fig.19 An embodiment of a sensing Foley catheter system with an additional vent for pressure relief and sterility is illustrated.

[0063] Fig. 20 An embodiment of a sensing Foley catheter system having a pressure relief vent and a pressure relief valve is illustrated.

[0064] Fig.21 Embodiments of collection containers, chambers, or cassettes that may be included in a sensing Foley catheter system to detect bacteria, blood, and / or other substances in urine using UV / light spectroscopy are shown.

[0065] Fig.22A Shown are the various wavelengths of light absorbed by E. coli in urine, red blood cells, and plasma.

[0066] Fig. 22B An embodiment of a display is shown.

[0067] Fig.23 An embodiment of a cassette comprising partitions or flaps is shown.

[0068] Fig.24 and Fig.25 A graph is shown representing a pressure bladder inflation method in some embodiments.

[0069] Figure 26-28 A flow chart showing possible logic in various embodiments of the present invention is shown.

[0070] Fig.29 An embodiment of a sensing Foley catheter system with a circuit controller in a patient environment is shown.

[0071] Fig.30 An embodiment of a sensing Foley catheter system with a circuit controller in a patient environment is shown.

[0072] Fig.31 An embodiment of a sensing Foley catheter system with a circuit controller in a patient environment is shown.

[0073] Fig.32 An embodiment of a sensing Foley catheter system with a circuit controller in a patient environment is shown.

[0074] Fig.33Details of the loop controller are shown with possible input parameters and output actions.

[0075] Fig.34 is a graph of ultrasound and pressure measurements of volume divergence.

[0076] Fig.35 The distal end of an embodiment of a sensing Foley catheter is shown.

[0077] Fig.36 An embodiment of a filter within a capsule is shown.

[0078] Fig.37 An embodiment of a filter within a bladder is shown with the bladder inflated.

[0079] Fig.38 An embodiment of a filter within a balloon is shown with the balloon deflated.

[0080] Fig.39 An embodiment of a filter within a capsule is shown.

[0081] Fig.40 An embodiment of a filter within a capsule is shown.

[0082] Fig.41 An embodiment of a filter within a capsule is shown.

[0083] Fig.42 An embodiment of a filter within a capsule is shown.

[0084] Fig.43 An embodiment of a filter within a capsule is shown.

[0085] Fig.44 An embodiment of a filter within a capsule is shown.

[0086] Fig.45 An embodiment of a filter within a capsule is shown.

[0087] Fig.46 An embodiment of a filter within a capsule is shown.

[0088] Fig.47 An embodiment of a balloon having multiple access lumens is shown.

[0089] Fig.48 and Fig.49 An embodiment of a capsule is shown.

[0090] Figure 50-53 Various embodiments of balloon catheters having a gas permeable membrane are shown.

[0091] Fig.54 A controller for measuring gas levels via a balloon catheter is shown.

[0092] Fig.55 and Fig.56 is a schematic diagram of a gas measurement conduit / controller system.

[0093] Fig.57A and 57B An embodiment of a gas measurement add-on component is shown.

[0094] Fig.58A A table is shown listing combinations of parameters that allow for possible signatures for identifying acute kidney injury and UTI based on patient parameters.

[0095] Fig.58B A table is shown listing combinations of parameters that allow for possible signatures for identifying acute kidney injury, sepsis, and acute respiratory distress syndrome based on patient parameters.

[0096] Fig.59 A pressure signature curve within the collection chamber during clearing of a gas lock is shown.

[0097] Fig.60 is a block diagram of a data processing system that may be used with any embodiment of the present invention.

[0098] Fig.61 Alternative wavelengths that may be used to identify red blood cells and / or plasma / white blood cells are shown.

[0099] Fig.62 Urine output data is shown immediately following administration of a diuretic.

[0100] Fig.63A -B shows how a smaller diameter lumen may compare to a larger diameter lumen in the vent / filter area.

[0101] Fig.64 The curved barb region is shown.

[0102] Fig.65 An embodiment of a sensing Foley catheter system with a vent tube is shown.

[0103] Fig.66 A sensing Foley catheter system with a separate positive pressure ventilation tube is shown.

[0104] Fig.67 Show Fig.66 Magnified view of the barb region.

[0105] Figure 68-86 The barb regions of various embodiments of the sensing Foley catheter system are shown.

[0106] Fig.87 An embodiment of a sensing Foley catheter system with an internal vent is shown.

[0107] Fig.88 An embodiment of a sensing Foley catheter system with an internal vent is shown.

[0108] Fig.89 An embodiment of a sensing Foley catheter system with an internal ventilation tube and a positive pressure tube is shown.

[0109] Fig.90 An embodiment of a sensing Foley catheter system with an internal vent is shown.

[0110] Fig.91A -B shows an embodiment of a sensing Foley catheter system with an internal vent.

[0111] Fig.91C -D shows an embodiment of a sensing Foley catheter system with concentric vents and drainage lumens.

[0112] Fig.92A and Fig.92B Some embodiments of drainage lumens are shown.

[0113] Figures 93A to 93E Another embodiment of a drainage lumen is shown.

[0114] Figures 94A-94C An embodiment of a sensing Foley catheter system is shown in which the pressure sensor is on a separate catheter.

[0115] Fig.95A -C shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0116] Fig.96A -D shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0117] Fig.97A -D shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0118] Fig.98A -D shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0119] Fig.99A -C shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0120] Fig.100A -C shows an embodiment of a sensing Foley catheter system with a bubble reduction mechanism.

[0121] Fig.101A and Fig.101B An embodiment of a sensing Foley catheter system with a bubble reduction mechanism is shown.

[0122] Fig.101C , 101D and 101E show an embodiment of a sensing Foley catheter system having a spiral flow path within a collection reservoir.

[0123] Fig.102 The pressure waveform is shown and its disappearance using a pressure bladder.

[0124] Fig.103 Sample clinical data illustrating a method of removing noise from a cardiac signal using an ECG is shown.

[0125] Fig.104 Sample clinical data illustrating stroke volume variability analysis using a model waveform are shown.

[0126] Fig.105A and Fig.105B A view of a cassette side component showing an embodiment of a sealing mechanism for some cavities between the cassette and the controller / monitor.

[0127] Fig.106 Shows Fig.105A and Fig.105B The controller side component of the embodiment of the sealing mechanism shown.

[0128] Fig.107A and Fig.107B A view showing an embodiment of a cavity connection sealing mechanism between a cassette and a controller is shown.

[0129] Fig.108 An embodiment of a cavity connection sealing mechanism on the back side of the cassette is shown.

[0130] Fig.109 A cross-sectional view of the cavity connection sealing mechanism on the back side of the cassette is shown.

[0131] Fig.110 Dimensional view of a cassette side component showing an embodiment of a sealing mechanism for some cavities between the cassette and the controller / monitor.

[0132] Fig.111 A force view of a cassette side component is shown of an embodiment of a sealing mechanism for some cavities between the cassette and the controller / monitor.

[0133] Fig.112 An embodiment is shown that includes a venting mechanism that can be added to any urine drainage system that includes a sampling port.

[0134] Fig.113 An embodiment including a pump / impulser is shown.

[0135] Fig.114 Embodiments are shown where the drain tube includes a coiled or compressed portion.

[0136] Fig.115A and Fig.115B An embodiment of a barb comprising a tube seating mechanism is shown.

[0137] Figures 116A-116E An example of a possible method to predict the risk of renal injury earlier than the RIFLE criteria is shown.

[0138] Fig.117A -C shows an embodiment of a sensing Foley system including a peristaltic pump.

[0139] Figures 118A-118C Example screenshots for embodiments disclosed herein are shown.

[0140] Fig.119A -B shows an embodiment of a sensing Foley catheter system including analysis and recording of various urine parameters.

[0141] Detailed description of the invention

[0142] Preferred embodiments of the present invention are described in detail herein. However, alternative embodiments of the various features of the device are also possible. Examples of these embodiments are provided below, but the scope of the present invention is not limited to these specific configurations.

[0143] Sensing Foley Catheter

[0144] Figure 1 An embodiment of a sensing Foley catheter and several of its features are shown. The catheter may be understood to have various sections depending on its arrangement when the catheter is inserted into a human subject, such as a proximal portion that remains outside the subject, a central or urethra-residing portion, and a distal or urinary bladder-residing portion.

[0145] Various lumens pass through the length of the catheter 102, such as an air or fluid cavity that communicates with the bladder retention bag 104 and the retention bag port 118. The urine drainage cavity has one or more distal openings 106 that reside in the bladder portion of the catheter and has an opening at the proximal end 114 of the catheter. The urine drainage cavity can be connected to a urine drainage tube that delivers urine to a collection container. The urine drainage tube can be separated from or integrated with the sensing Foley catheter. In some embodiments, the drainage cavity and the distal opening in the bladder can also be used as an infusion catheter through which a medicament can be infused, or a heated or cooled fluid can be infused. An analyte sensor (not shown) or a temperature sensor (not shown) can be disposed on the catheter, either on the urethral portion of the catheter or on the bladder resident portion. An electrical or optical fiber conductor can be disposed in a cavity that allows the sensing signal to be transmitted between the distally disposed sensor and the proximal portion of the catheter and further transmitted to a data processing device or controller.

[0146] An inflatable pressure sensing bladder 108 (or a pressure sensing membrane arranged throughout the opening) can be located at or near the distal end of the catheter. Embodiments of the pressure sensing bladder or pressure sensing membrane can be understood to include a pressure interface having a distal-facing surface exposed to pressure from within the bladder and a proximal-facing surface exposed to a proximal fluid column. The pressure sensing bladder or membrane is in fluid communication with the fluid column or cavity, which is in fluid communication with a pressure port 116 at or near the proximal end of the catheter. Embodiments of the fluid column (filled with a fluid, either liquid or gas) can include a dedicated cavity or a shared cavity.

[0147] In some embodiments, a temperature sensor may be present at or near the distal end of the catheter.The temperature port 110 may include a temperature communication line 112 that connects the temperature sensor to a display, connector, and / or controller.

[0148] Note that although Figure 1 The proximal end of the catheter is shown to include multiple separate ports, but some or all of the ports may be integrated into a single port or integrated into a urine drainage line that runs to a urine drainage system and / or controller. Other lumens and / or ports may also be present.

[0149] The pressure-based physiological parameters that the sensing Foley catheter system can sense and / or determine by the controller based on the sensed parameters may include, for example, peritoneal pressure, respiratory rate and heart rate, relative lung tidal volume distribution, cardiac output, relative cardiac output, and absolute cardiac stroke volume. Some embodiments of the Foley-type catheter may be further equipped with a temperature sensor, one or more analyte sensors, electrodes, and any one of the paired light sources and sensors. Such further equipped embodiments are capable of transmitting other forms of physiological data, such as blood pressure, oxygen saturation, pulse oximetry, EKG, and capillary filling pressure.

[0150] Embodiments of sensing Foley catheters may be able to sense any one or more of a number of clinically relevant parameters such as those included in the following examples: urine pH, urine oxygen content, urine nitrate content, respiratory rate, heart rate, perfusion pressure of the bladder wall or urethra wall, temperature inside the bladder or urethra, electrocardiography via sensors on the bladder wall or urethra, respiratory volume, respiratory pressure, peritoneal pressure, urine glucose, blood glucose via the urethral mucosa and / or bladder mucosa, urine protein, urine hemoglobin, blood pressure. In some embodiments, the catheter can sense multiple parameters, but some embodiments may be limited to as few as a single parameter (e.g., respiratory rate in a patient in respiratory distress) for the intended application.

[0151] The disclosed technology captures high-resolution temporal distributions of peritoneal pressure (pressure as a function of time) from within the bladder, which can be converted and processed into different pressure distributions that can be assigned to specific physiological sources, including peritoneal pressure, respiratory rate, and heart rate. By tracking the pressure distribution at a sufficiently fast sampling rate (as provided by the technology), the pressure distribution can be further resolved and / or analyzed into relative lung tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume.

[0152] Thus, aspects of the disclosed technology relate to the fidelity and resolution of a pressure signal generated in response to changes in pressure within the bladder, which changes are reflected in a pressure distribution within the peritoneal cavity, which pressure distribution includes cumulative inputs from the above-mentioned physiological sources. Aspects of the technology further relate to the fidelity and resolution of the conversion of the pressure signal to a highly resolvable electrical signal. Aspects of the technology still further relate to processing the entire electrical signal distribution (a surrogate for the pressure distribution within the peritoneal cavity) into component distributions that can be assigned to physiological sources.

[0153] The sensitivity of the inflatable bladder as a pressure sensor depends in part on the pressure differential across the bladder membrane at baseline conditions. When the baseline pressure differential is close to zero, the bladder has the greatest sensitivity to pressure. As the baseline pressure differential increases, the sensitivity of the pressure sensing bladder decreases. Thus, the disclosed technology provides an automatic inflation method that maintains the bladder in an inflated state but with minimal pressure differential.

[0154] In order to effectively capture the physiological pressure distribution, the distribution needs to be sampled at a rate sufficient to resolve the natural frequency of changes in the distribution. This consideration is informed by the Nyquist-Shannon sampling theorem, which states that a sampling frequency of at least 2B samples / second is required to resolve events operating at a frequency of B cycles / second. As applied to physiological pressure cycles, for example, a heart rate of 70 beats / minute requires a sampling rate of at least 140 samples / minute to effectively capture the cycle. This relationship forms the basis of aspects of the disclosed technology that specify sampling rates that are specifically needed to capture physiological pressure cycles (such as relative lung tidal volume, cardiac output, relative cardiac output, and absolute heart stroke volume).

[0155] Embodiments of the technology include a pressure interface as may be represented by a bladder having either a flexible membrane or an inflexible membrane.

[0156] According to embodiments of the technology, an inflatable pressure sensing bladder may take on one or more of at least two basic forms (flexible or non-flexible). In a flexible bladder type that can be generally likened to a traditional party balloon, the pressure sensing bladder is formed of or includes a flexible membrane. Thus, the surface area of ​​the membrane expands or contracts depending on the expansion of the bladder. The compliance of the membrane determines various characteristics of the bladder as a whole at different expansion levels. When inflated, if unconstrained, the bladder maintains a substantially constant or preferred form or shape, such as the form or shape determined by the mandrel on which the bladder is formed. When the bladder expands from a minimum volume to its maximum volume, the membrane of the bladder maintains a certain level of tautness. Within the limits of the flexibility of the flexible membrane, an increase in pressure during inflation results in a consequent expansion of volume. The bladder as a whole may be considered partially flexible because its shape responds to the spatial constraints it may encounter when inflated or inflated, however the bladder does have a preferred or natural shape, and this shape preference prevents a certain level of shape flexibility or compliance such as exhibited by a non-flexible bladder.

[0157] In a non-compliant bladder, the expandable pressure sensing bladder is formed of or includes a non-compliant membrane or a substantially non-compliant membrane. Thus, the surface area of ​​the membrane does not expand or contract depending on the level of bladder expansion / pressurization. The non-compliant pressure sensing bladder can generally be likened to a conventional The lack of compliance of the membrane determines various characteristics of the bladder as a whole at different levels of expansion. When the bladder expands from a minimum volume to a level close to its maximum volume, the membrane of the bladder is soft and has a certain level of relaxation. The expansion of a non-flexible bladder occurs by an outwardly directed flattening of the wrinkles and folds in the membrane. The deflation or compression of a non-flexible bladder occurs by wrinkling and infolding, which are generally directed inwardly. When a non-flexible bladder is fully inflated (or substantially inflated) and not in a confined space, it assumes a preferred or natural shape determined by the geometry of the membrane or fabric of the bladder. However, in a partially inflated state, the bladder as a whole is highly soft and compliant, generally taking a shape as may be dictated by the confined space.

[0158] According to embodiments of the technology, the inflatable pressure sensing bladder may also include features of both basic forms (flexible and inflexible). In these embodiments, the membrane may include flexible regions and inflexible regions. As described above, this hybrid type of bladder as a whole behaves in a manner that extracts from the behavior of both flexible bladders and inflexible bladders. In addition, the flexible bladder can be formed with a membrane that does not have a uniform composition or thickness. In such embodiments, regions of different thickness or composition may have different degrees of compliance, thereby affecting the behavior of these regions during inflation of the bladder. In yet other embodiments, the compliance of the membrane may have a bias or polarity that tends to allow compliance in one or more directions and tends to not allow compliance in one or more other directions.

[0159] Embodiments of sensing Foley catheters include devices utilizing a very small pressure lumen for air delivery. Pressure readings using lumen diameters of 3mm, 1mm, and 0.5mm have been measured. Little degradation of the signal was seen when the air lumen diameter was reduced from 3mm to 1mm and 0.5mm.

[0160] These data indicate the suitability of an embodiment of the pressure transmission system for use in small diameter pediatric catheters down to 4F in size. In this embodiment, the tip of the catheter may also be a lower profile than the rest of the catheter to allow for a consistently small diameter even with the addition of a pressure sensing bladder. Thus, the catheter of the present invention is particularly suitable for pediatric indications, where there is an acute need for more appropriate, less invasive monitoring methods. In another embodiment, the retaining bladder itself may be used as the pressure bladder to minimize the number of cavities required. In one embodiment, the retaining bladder is used in its fully inflated state and is only used to track macroscopic trends in IAP. In another embodiment, the retaining bladder is only slightly inflated to increase the sensitivity of the bladder to small changes in pressure. This embodiment allows for more sophisticated measurements of microscopic parameters such as heart rate, relative stroke volume, relative cardiac output, respiratory rate, and relative tidal volume. Smaller pressure cavities also allow for more space in larger catheters for other technologies such as sensors.

[0161] In embodiments of the sensing Foley catheter in which the retention bladder is used as a pressure bladder, the pressure measured within the retention bladder is offset by the pressure required to inflate the bladder just enough to allow it to function as a retention bladder. As a result, the inflation pressure and the pressure that may result from the retention bladder contacting the inner surface of the bladder need to be subtracted from the pressure reading. In this way, smaller pressure changes similar to those measured by a separate pressure bladder can be tracked. The inflation pressure offset can be determined by measuring the pressure within the retention bladder when it is first inserted into the patient or by measuring the retention bladder inflation pressure outside the patient or by other means. The retention bladder can be filled with a fluid, air, or any other suitable gas.

[0162] Embodiments of the disclosed technology may include embodiments in which the pressure sensor is a mechanical pressure sensor, such as those using fiber optic, strain gauge, magnetic, resonance, and / or other suitable technology.

[0163] Figure 2 An example of respiratory rate sensing data from a human subject as provided by an embodiment of a sensing Foley catheter system is shown. During this test, the subject performed the following breathing sequence: (1) breath hold at the end of exhalation, (2) Valsalva, (3) hyperventilation, (4) Valsalva, and (5) breath hold at the end of exhalation.

[0164] Figure 3 Shown in Figure 2 The breathing profile shown is similar to a detailed portion of a normal breathing cycle in a breathing profile. Note that the pressure curve clearly shows the breathing peak (and hence the breathing rate can be determined) and shows the heart rate peak (and hence the heart rate can be determined).

[0165] Figure 4 An example of cardiac rate and relative cardiac output sensing data from a human subject as provided by an embodiment of a sensing Foley catheter system and an EKG trace as measured simultaneously and independently is shown. The graph clearly shows that the heart rate peak as measured by the sensing Foley catheter is aligned with the heart rate.

[0166] Figure 5 Data related to relative cardiac output sensing during a human leg-raising exercise is shown, wherein cardiac output increases as evidenced by an increased amplitude of the heart pulse.

[0167] Figure 6 and Figure 7 The data shown in were obtained from studies conducted in Yorkshire pigs under an IACUC-approved protocol. Figure 6 An example of peritoneal sensing data focused on respiratory rate from a pig as provided by an embodiment of a sensing Foley catheter system is shown. Figure 7 An example of a porcine study is shown that demonstrates the ability of an embodiment of the sensing Foley catheter system to detect intra-abdominal hypertension. In this study, the peritoneal cavity was entered with a 5 mm Tenamian trocar. The trocar was then attached to a 5F bag with Lactated Ringer's solution by a peristaltic pump, and the solution was infused at a rate of approximately 1 L per minute. Once a pressure of approximately 20 mmHg was obtained, fluid flow was interrupted, and there was no net fluid flow into or out of the cavity thereafter.

[0168] Figure 8Intra-abdominal pressure, respiratory wave pressure, and cardiac pressure are schematically arranged as a two-dimensional relationship curve diagram of pressure (mm Hg on a logarithmic scale) and frequency (Hz). It can be seen that there is an inverse relationship between pressure and frequency, and when arranged in this way, various physiological pressure-related parameters occupy different segments. It is through the differences in these pressure distributions and / or frequency distributions that embodiments of the methods disclosed herein can distinguish a single overall chronological pressure distribution into different sub-distributions according to their physiological origins. Intra-abdominal pressure measurements can be distinguished in a frequency range of about 0 Hz to about 0.5 Hz. Respiratory pressure measurements can be distinguished in a frequency range of about 0.25 Hz to about 0.75 Hz. Cardiac pressure measurements can be distinguished in a frequency range of about 0.75 Hz to about 3.0 Hz. Intra-abdominal pressure measurements can be distinguished in an amplitude range of about 5 mm Hg to about 30 mm Hg. Respiratory pressure measurements can be distinguished in an amplitude range of about 0.5 mm Hg to about 5 mm Hg. The cardiac pressure measurements may be resolved within an amplitude range of about 0 mm Hg to about 0.5 mm Hg. The sampling frequency - the frequency at which pressure measurements are made - is preferably twice the resolution frequency. For example, the sampling frequency for intra-abdominal pressure measurements may be about 0 Hz-1 Hz, the sampling frequency for respiratory pressure measurements may be 0.5 Hz-1.5 Hz, and the sampling frequency for cardiac pressure measurements may be 1.5 Hz-6 Hz.

[0169] Fig. 9 A flow chart of an embodiment of a method for monitoring pressure as it dynamically occurs in the intra-abdominal cavity as waves of varying frequencies and amplitudes (as detected from within a urinary bladder) is provided. Through the medium of a pressure interface, a high-fidelity pressure distribution is generated and transmitted proximally through a fluid column. More proximally, a pressure transducer converts the high-fidelity pressure waves into high-fidelity electrical signals that provide information of the pressure frequency and amplitude. The generated high-fidelity electrical signals are then processed by a controller to generate a subset of data reflecting components within the overall pressure distribution, such subsets being attributable to specific physiological sources, such as peritoneal pressure, respiratory rate, heart rate, relative cardiac output, and patient movement or activity.

[0170] Sensing Foley Catheter System

[0171] Fig. 10A An embodiment of a sensing Foley catheter used in conjunction with an embodiment of an air lock clearing mechanism and a fluid collection and analysis system is shown.Both urine drainage and pressure readings benefit from the elimination or reduction of air locks in urine drainage lines.

[0172] Sensing Foley Catheter 1000 is similar to Figure 1The sensing Foley catheter is shown in use in the bladder 1014. Note that Fig. 10A In the embodiment shown, Figure 1 Several of the ports at the proximal end of the catheter shown are combined. A urine drainage tube 1001 is also shown here. The urine drainage tube can be combined with a sensing Foley catheter, or it can be a separate component. The urine drainage tube 1001 and / or the sensing Foley catheter can also include a venting barb (or barb) 1016, or the venting barb can be a separate component. An air plug clearing mechanism and a fluid collection and analysis system 1002 are also shown here and are in fluid communication with the urine drainage tube 1001, which is in fluid communication with the sensing Foley catheter 1000. The air plug clearing mechanism and the fluid collection and analysis system include a base / controller 1018, a fluid collection bag 1020, and a reservoir or cassette 1022. The combination of the sensing Foley catheter 1000, the urine drainage tube 1001, the air plug clearing mechanism, and the fluid collection and analysis system 1002 is also referred to as a sensing Foley catheter system in this article. The sensing Foley catheter, urine drainage tube, and reservoir / cassette may be disposable and sold as a unit. Fig. 10C This disposable assembly is shown and includes a sensing Foley catheter 1000 , a urine drainage tube 1001 (including a vent barb), and a reservoir / cassette 1022 .

[0173] The vent barb 1016 may include one or more vents 1006 and a urine sampling port 1004. In this embodiment, the vent 1006 is preferably made of a membrane that allows the transmission of gas rather than liquid, such as a hydrophobic membrane. An example of one such exemplary vent is PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), or (from Pall Corporation of PortWashington, New York) The vent 1006 may be a one-way valve that prevents air from leaving or entering the drainage line. In a preferred embodiment, the one-way valve is used to prevent air from leaving the drainage line, but allows air to enter the drainage line through the vent 1006. In this way, the valve also prevents urine from coming into contact with the vent 1006.

[0174] The urine drainage tube 1001 may include several chambers, including a pressure chamber 1010, a temperature chamber 1008, and a urine chamber 1012. The pressure chamber 1010 is in fluid communication with the pressure sensing bladder 108 and a pressure transducer interface 1026 in the controller 1018. The temperature chamber 1008 is in fluid communication with a temperature sensor (not shown) in the sensing Foley catheter and also a temperature connector port 1024 in the controller. The urine chamber 1012 is in fluid communication with one or more openings 106 and a urine reservoir or cassette 1022.

[0175] The disposable measuring container, collection container, chamber or cassette component 1022 is designed to be mounted into the cassette base, base or controller 1018 and interfaced with components of the controller. The controller pump interface (behind the cassette pump interface 1148) is connected to the pump 1134 and the cassette pump interface 1148 on the disposable cassette component. The pump is designed to create a vacuum inside the cassette component, which is then transferred to the urine drainage cavity in the drainage line. Preferably, the collection container / cassette is rigid so as to maintain a constant volume when the pump applies negative pressure. The level of negative pressure applied can be monitored by a pressure sensor. During the clearing of the air lock, the pressure follows the following Fig.59The identification mark curve shown. When suction is applied, the pressure decreases, eventually reaching an inflection point when the meniscus of urine passes through the lowest point in the drainage tube. At this point, less suction is needed to continue to clear the air plug, so once the air plug is completely cleared, the pump power can be reduced to minimize the amount of suction delivered to the bladder. For example, once the air plug is cleared and before the container has time to balance with the atmosphere, a larger container without this pressure sensing feature transmits a considerable negative pressure to the bladder. The controller pressure interface (behind the box pressure interface 1150) is connected to a pressure measuring device (such as a pressure transducer) and is connected to the box pressure interface 1150. The pressure measuring device is designed to measure the volume of urine or other fluids based on the pressure applied on the pressure measuring device, and the pressure measuring device can be a pressure transducer. The ultrasonic transducer interface 1130 also provides urine volume measurement. Ultrasonic measurement can be used in combination with pressure measurement, or either measurement can be used to determine the volume output of urine or other fluids. The active pinch valve 1132 is designed to be connected to the outflow tube of the box. The pinch valve is used to control the emptying of the cassette container, and the pinch valve is controlled by a controller so that when the urine output reaches a certain volume in the cassette as determined by pressure and / or ultrasonic measurement, the pinch valve releases urine / fluid. The volume of urine in the cassette is measured, and when the urine reaches a certain volume, the urine is emptied into the urine drainage bag 1020 through the pinch valve. For example, when the volume of urine in the cassette reaches about 50ml, the cassette can be emptied. Alternatively, when the volume of urine in the cassette reaches about 40ml, the cassette can be emptied. Alternatively, when the volume of urine in the cassette reaches about 30ml, the cassette can be emptied. Alternatively, when the volume of urine in the cassette reaches about 20ml, the cassette can be emptied. Alternatively, when the volume of urine in the cassette reaches about 10ml, the cassette can be emptied. In this way, the urine output volume can be accurately measured over time.

[0176] In some embodiments, a capacitive micromachined ultrasonic transducer (CMUT) can be used to determine the volume of urine in the cassette. This can allow for a cheaper ultrasonic transducer that can cover the entire bottom of the cassette and / or one or more sides of the cassette. This can eliminate cassette tilt as a problem.

[0177] Emptying of the cassette may be enhanced or accelerated by pressurizing the cassette during the emptying process.

[0178] Alternatively, the controller may utilize a set time between cassette emptyings and measure the volume of urine in the cassette just prior to emptying. Alternatively, the controller may empty the cassette upon an event such as air lock removal triggered by pump activation. For example, the controller may establish a periodic air lock clearing cycle followed by measuring the volume of urine in the cassette followed by emptying the cassette.

[0179] For example, when the urine volume reaches about 50 ml, the controller can control the pinch valve to empty the reservoir / cassette. Alternatively, the controller can control the pinch valve to empty the reservoir / cassette once an hour after measuring the urine volume in the cassette. Alternatively, the controller can control the pinch valve to empty the reservoir / cassette during or after a urine drainage event (such as operation of a pump). Or the controller can control the pinch valve to use a combination of these triggers to empty the reservoir / cassette.

[0180] In addition to or in place of pressure and / or ultrasound, other techniques (including pressure-based, resistance-based, capacitance-based, ultrasound-based, or optical-based techniques) may also be used to measure urine volume. More than one technique may be used so that measurements can be compared to one another to improve the accuracy of volume measurements. More than one volume measurement by one or more techniques may be used for redundancy or backup, or in conjunction with one another to obtain a more accurate urine volume measurement.

[0181] For example, a camera can be used to determine the liquid level in a reservoir by identifying a fluid / air interface. Then, the known size of the reservoir can be used by the controller to calculate the fluid volume. The camera can also be used to determine the inclination of the system by identifying the edge of the fluid / air interface and the reservoir. The controller can calculate the angle between these to determine the inclination of the system. If the angle changes rapidly over time, the controller can determine that the system is in motion, for example, when the patient moves between rooms. When certain conditions are detected by the camera / controller, the controller can send an alarm with a signal. For example, a high inclination alarm, a motion alarm, a detection alarm (when blood, bubbles or other conditions are detected in urine), etc. In the case where the urine reservoir / system is placed on a horizontal surface, the inclination can be close to 90 degrees. In this case, the controller can determine that the reservoir has been placed on its side and it may not be functionally empty, or the urine may have an increased chance of flowing back into the drainage tube. The controller can automatically shut down certain functional aspects of the system, for example, drainage line clearing function, reservoir emptying function, etc. The controller may automatically place the system in a "dumb Foley mode" in which the urine drainage flow path bypasses the cassette and drains directly into the bag. The controller may additionally or alternatively close certain valves, such as a valve between the reservoir and the drainage tube.

[0182] Bed hooks 1116 are used to hang the controller to a bed or other equipment as needed. They can also be used to hang the controller to a portable device for transporting patients. The collection bag hook / hole 1102 is used to mount a drainage bag where the urine / fluid is ultimately collected after it passes through the pinch valve. The collection bag hook 1102 can be designed to provide strain measurement so that the weight of the fluid in the bag can be determined, and thus provide another method for determining the volume of the fluid in the bag. For example, a piezoelectric transducer can be used. Specific gravity determination can also be used by the controller to determine a useful volume measurement based on weight and specific gravity.

[0183] Screen 1110 is used to display information including current urine / fluid volume status, system status, etc. Screen 1110 can also be a touch screen and receive input, which includes settings, screen display changes, menu changes, etc. Pressure port 1026 is connected to bladder pressure line 1010, which uses a sensing Foley catheter to measure bladder pressure if used. Alternatively, the pressure port can be located in the cassette base below cassette 1022 or elsewhere in the controller / base. Temperature port 1024 is connected to a thermistor / temperature sensor, which either measures body temperature via cavity 1008 or by other means through a sensing Foley catheter. Temperature output port 1122 is used to transmit any temperature measurement results to an external device and / or monitor. Adapter port 1124 is used to adapt the controller to other devices, such as in the case of an RFID adapter. This can be used to activate any additional / advanced features, such as IAP, respiratory rate, heart rate, cardiac output, or any other parameter that can be measured by a sensing Foley catheter. This allows additional parameters to be activated and paid for by the hospital only when that information is needed. The activation of advanced features can also be controlled by, for example, using different disposable components. Alternatively, advanced features can be activated by software upgrades, which are either purchased as part of a disposable item or separately. Software upgrades can be implemented wirelessly, by USB dongles, by micro SD cards, by EPROM cards, or by other suitable technologies. The data of each patient and / or the patients gathered can also be saved by the controller. Patient data can be saved to a memory, USB, micro SD card, EPROM card, hard drive, or other places. Patient data can be transmitted to another storage device, such as a server on the Internet or intranet, wirelessly or by a wired connection. Patient data can be made anonymous. Patient data (such as patient ID) can be stored in an RFID adapter so that data unique to a particular patient is identified by the controller and associated with the disposable components used by the patient. The RFID adapter can be located on the disposable part of the system, such as on a cassette 1022 or other places where a disposable component is connected to a non-disposable component by an interface. In addition, all collected patient data can be stored in an RFID adapter so that different monitors can be used for the same patient without cutting off the disposable part of the system.

[0184] The power LED / indicator 1114 is an indication of whether the power is on or off. The error LED / indicator 1112 is an indicator of whether any errors have occurred within the system. The error details may be displayed on the screen 1110, but the indicator 1112 alerts the user that an error exists. The indicator may also incorporate an audible or other alarm.

[0185] Port 1108 is used for downloading, uploading, software upgrades, connecting other devices, etc., such as integration with an EMR (electronic medical record) system. Port 1108 can be a USB port or other suitable port. SD port 1106 is used for data download. Power port 1104 is used to connect the controller to a wall or other power source to power the controller.

[0186] The urine / fluid drainage bag 1020 includes one-way valves 1136 connected to the overflow tube 1138 and the outflow tube 1140 to prevent urine / fluid from leaving the drainage bag once it is collected. These valves also prevent air from entering the collection container 1022 when the pump 1134 draws a vacuum, so that the vacuum acts on the drainage tube instead of the bag. In a preferred embodiment, a single valve is used for both the overflow tube and the outflow tube. The mounting hook / hole 1102 allows the drainage bag 1020 to be removably connected to the controller 1018. The vent 1142, which can be a hydrophobic or other vent, allows air or gas to leave the drainage bag, but does not allow fluid to leave the bag. This prevents excess air and prevents possible accumulation of pressure in the bag, and thus allows efficient filling of the drainage bag. The graduated markings 1144 show a rough measurement of the volume of fluid in the bag when the fluid is collected. The outflow valve 1146 can be used to empty the bag of fluid / urine. Preferably, the valve is easily operable by one person. The collection bag hook 1102, when designed as a strain gauge element, can also force an alarm to sound if the bag reaches full capacity and needs to be emptied. An alarm can also sound if there is an unnecessarily large force on the bag, such as if the bag is pulled or caught on an obstacle when the patient is moved. Weight or mass can also be used to determine if the bag is full, such as using a scale. Alternatively or additionally, a pressure reading within the reservoir / cassette can be used to determine when the bag is full.

[0187] Overflow baffle 1137 is shown in collection container / reservoir / cassette 1022. The overflow baffle is typically at a height above the level at which the controller empties the cassette. For example, if the controller empties the cassette when the fluid volume reaches 50 ml, the overflow baffle will reach a height above the level of the 50 ml volume. For example, the overflow baffle may be approximately 5-10 mm above the level of the emptied volume. Alternatively, the overflow baffle may be approximately 10-20 mm above the level of the emptied volume. Alternatively, the overflow baffle may be approximately 20-30 mm above the level of the emptied volume. Alternatively, the overflow baffle may be approximately 30-40 mm above the level of the emptied volume. Alternatively, the overflow baffle may be approximately 40-50 mm above the level of the emptied volume. Alternatively, the overflow baffle may be approximately 50-100 mm above the level of the emptied volume. The path between the urine collection area 1135 and the overflow area 1139 can be direct (as shown here), or can be more tortuous or convoluted, as in Figures 101B-101E As shown in .

[0188] Patient temperature is measured using a thermistor / temperature sensor within the patient's body. This temperature can be transmitted through the controller for display on a third-party device. Fig. 10B Shows how a parallel potentiometer can be used to reduce errors in temperature measurement before it is transmitted to an external display or external device.

[0189] The drainage bag can be made of clear vinyl or other suitable material. The one-way valve can be made of vinyl or other suitable material. The hydrophobic vent can be made of ePTFE, Versapor or other suitable material. The outflow valve can be made of PVC, PC or other suitable material.

[0190] Pressure readings from the sensing Foley catheter can be used to trigger the pump, and thus empty the drainage tube. For example, when the pressure sensed in the bladder exceeds a preset number, the pump can engage to move urine through the drainage tube faster.

[0191] The controller / base and / or reservoir / cassette may include an accelerometer or other sensor to determine when the controller / cassette is level and when it is not level. An alarm may sound when the controller / cassette is not level. Alternatively, the urine volume measurement may be adjusted to account for different angles in the system.

[0192] The bottom of the urine reservoir in the cassette may have rounded edges, or be configured so that urine empties completely from the cassette when the pinch valve is opened.

[0193] In some embodiments, the controller / monitor may be incorporated into the bed itself.

[0194] Fig. 10Bis a detailed view of the air lock clearing mechanism and fluid collection and analysis system 1002. Screen 1110 displays a user interface including patient parameters and a touch screen or other control function. Heart rate area 1152 shows the patient's heart rate determined by the controller based on the intra-bladder pressure measurement sensed by the sensing Foley catheter. Respiration rate area 1154 shows the patient's respiratory rate determined by the controller based on the intra-bladder pressure measurement sensed by the sensing Foley catheter. Core body temperature area 1156 shows the patient's core body temperature as sensed by the temperature sensor in the sensing Foley catheter or other device. Urine output area 1158 shows the patient's current and / or average urine output determined by the controller based on urine volume measurement as measured by a pressure measurement device connected to the pressure interface 1150 and / or the ultrasonic transducer interface 1130. Sepsis index area 1160 shows the patient's likelihood of sepsis determined by the controller based on one or more patient parameters collected and / or calculated. For example, temperature, abnormal heart rate, abnormal respiratory rate, and / or urine output, or other factors, may be considered in determining risk for sepsis. Trends in these parameters may also be used in assessing risk. For example, decreased urine output, increased heart rate, elevated or decreased core temperature may be indicators of sepsis.

[0195] Other risk assessments may be determined by the controller and displayed in addition to or as an alternative to the sepsis index. These include risk assessments for acute kidney injury, urinary tract infection, intra-abdominal hypertension, abdominal compartment syndrome, infection risk, sepsis, ARDS (acute respiratory distress syndrome), and the like. For example, sample risk algorithms for acute kidney injury and urinary tract infection are shown in Fig.58A Sample risk algorithms for acute kidney injury, sepsis, and acute respiratory distress syndrome are shown in Fig.58B Measured urine parameters may include conductivity, specific gravity, urine output, presence of infection, bacteria, white blood cells, oxygen tension, and the like.

[0196] Graphic indicator 1162 displays historical data for any of these areas. For example, a user may be able to toggle a graphical display by touching the screen and display the patient's urine output, temperature, heart rate, respiratory rate, sepsis index, risk of acute kidney injury, urinary tract infection, intra-abdominal hypertension, abdominal compartment syndrome, risk of infection, etc., or a history of any other relevant parameter. The time range of the history may be all time, daily, hourly, or any time period set by the user. Any risk factor that is outside the range and therefore at an elevated risk may be automatically displayed here or elsewhere on the display. Alarms and / or ranges may be set by the user and may include absolute values ​​as well as trends over time. For example, a rise of more than 2 degrees in core body temperature within a specific time range may display a visual or sound an audible alarm.

[0197] Fig.11A Shown with Fig. 10A 1018 or reservoir / cassette 1022 rather than on a vent barb (or barbs) 1182. In this embodiment, the vent 1180 is in fluid communication with the urine drainage lumen 1012 via a vent lumen 1184, which is fluidly connected to the urine lumen 1012 at the barbs 1182. In this embodiment, the vent 1180 is in fluid communication with the urine drainage lumen 1012 via a vent lumen 1184, which is fluidly connected to the urine lumen 1012 at the barbs 1182. Fig. 10A The barb design is simplified compared to the embodiment shown, and the drainage tube simply has an additional lumen. The vent can be located anywhere in the system, and the fluid interface with the urine lumen can also be anywhere in the system.

[0198] Fig. 11B Shown with Fig.11A 1022 and / or the controller 1018. A vent lumen may pass from the barb 1182 along the drainage tube 1012 within the vent tube 1184. The vent lumen may terminate external to the cassette and / or the controller, or, as shown here, may pass through the cassette and possibly through the controller and incorporate a gas permeable vent / filter 1180. Fig. 11BAlso shown is valve 1186. The valve can be a one-way valve that allows a fluid (e.g., atmosphere) stream to flow through the vent cavity and flow into the vent via a barb or other position along the vent or Foley catheter (or in the base / controller 1018). The valve prevents fluid (such as urine and / or air) from flowing through the vent and possibly reaching the filter. The valve can be passive, as shown here, or can be actively controlled by the controller. The valve can be in the vent or anywhere along the vent, including in a barb, anywhere along the vent, in a cassette, in a controller, or outside the controller, such as on the non-patient side of the controller.

[0199] In some embodiments, the valve is actively controlled by controlling the negative pressure in the drainage tube via a controller. The valve can be opened by drawing negative pressure in the drainage lumen of the drainage tube by the controller, and the valve can be closed by reducing the vacuum applied to the drainage tube (i.e., applying a small negative pressure, applying zero pressure, or applying a slightly positive pressure to the drainage lumen) by the controller. Because the drainage lumen of the catheter and the drainage tube is in fluid communication with the lumen of the ventilating tube, the negative pressure applied to the drainage tube is also applied to the lumen of the ventilating tube, and the valve opens when the pressure differential across the valve exceeds the rupture pressure of the valve. The valve can be closed again by reducing the vacuum applied to the drainage lumen and thereby reducing the pressure differential across the valve to a pressure below the rupture pressure of the valve. In this way, the controller can actively control the opening and closing of the valve in the ventilating tube, even in cases where the valve itself is a passive valve.

[0200] In some embodiments, the controller actively opening the valve can be done periodically, for example, on a regular schedule. Fig.11F . For example, the controller may open the valve at least once every 30 minutes (represented by T1), may keep the valve open for at least 15 seconds (represented by T2), and may then close the valve for another 30 minutes until the cycle begins again. The difference between the vacuum applied to open the valve and the vacuum applied to keep the valve closed is represented by DIFF in the figure. DIFF is greater than the burst pressure difference of the valve. Alternatively, T1 may be at least 60 minutes. Alternatively, T1 may be at least 20 minutes. Alternatively, T1 may be at least 10 minutes. Alternatively, T1 may be at least 5 minutes. Alternatively, T2 may be at least 5 seconds. Alternatively, T2 may be at least 10 seconds. Alternatively, T2 may be at least 20 seconds. Alternatively, T2 may be at least 30 seconds.

[0201] Fig.11F The valve closing pressure is shown at a negative pressure, however, the valve closing pressure may be zero or may be positive.

[0202] Alternatively, the cycle length may be variable, with T1 and / or T2 depending on the urine output flow rate. The cycle may alternatively be based on the system sensing an air lock in the drain tube. This may be accomplished by measuring the pressure within the system (e.g., vacuum pressure within the drain tube or pressure at the barb).

[0203] In some embodiments, valve 1186 can be in place without a filter. In some embodiments, a filter can be between the drainage lumen and valve 1186.

[0204] In some embodiments, the vent tube 1184 is integrated with the drain tube 1012 along all or a portion of the drain tube's length.

[0205] The valve may be a duckbill valve, umbrella valve, ball valve, dome valve, Belleville valve, cross slit valve, x-fragm valve or any other valve suitable for medical applications. The valve may have a very low burst pressure, or may have a higher burst pressure, but typically between zero and the magnitude of the negative pressure drawn by the vacuum pump.

[0206] Fig. 11C Shown with Fig. 11B An embodiment of a sensing Foley catheter system similar to the sensing Foley catheter system shown in FIG. 1 is shown in FIG. 1 . In this embodiment, the vent includes a portion of a lumen having a smaller diameter between the barb and the valve. The smaller inner diameter tube between the barb and the valve creates an air column between the valve and the barb, which will generally prevent urine from entering the vent when the vent valve is closed. When the vent valve is open, the fluid flow generally flows in another manner that also prevents urine from entering the vent (i.e., into the drainage lumen).

[0207] Fig.11D An example of a ventilator having segments of different diameters is shown. The first segment 1188 is the segment closest to the patient, and its internal ID is ID1 and the length is L1. In this embodiment, valve 1186 allows fluid to flow generally only from right to left, as shown by the dotted arrows. The second segment 1190 is further away from the patient, and the internal ID is ID2 and the length is L2. In some embodiments, L1 is less than L2, and ID1 is less than ID2. In some embodiments, ID1 is less than ID2, but the lengths can vary or can be the same as each other. L1+L2 can be approximately the same length as the drainage tube.

[0208] In some embodiments, ID1 may be approximately 1.8-2.0 mm. In some embodiments, ID1 may be approximately 1.6-1.8 mm. In some embodiments, ID1 may be approximately 1.4-1.6 mm. In some embodiments, ID1 may be approximately 1.2-1.4 mm. In some embodiments, ID1 may be approximately 1.0-1.2 mm. In some embodiments, ID1 may be approximately 0.8-1.0 mm. In some embodiments, ID1 may be approximately 0.5-0.8 mm. In some embodiments, ID1 may be approximately 0.2-5 mm. In some embodiments, ID1 may be less than approximately 1 mm. In some embodiments, ID1 may be less than approximately 2 mm. In some embodiments, ID1 may be less than approximately 3 mm. In some embodiments, ID1 may be less than approximately 4 mm. In some embodiments, ID1 may be less than approximately 2 mm. Preferably, ID1 is small enough to hold the siphon over all or part of its length.

[0209] In some embodiments, ID2 may be about 1.8-2.0mm. In some embodiments, ID2 may be about 1.6-1.8mm. In some embodiments, ID2 may be about 1.4-1.6mm. In some embodiments, ID2 may be about 1.2-1.4mm. In some embodiments, ID2 may be about 1.0-1.2mm. In some embodiments, ID2 may be about 0.8-1.0mm. In some embodiments, ID2 may be about 0.5-0.8mm. In some embodiments, ID2 may be about 0.2-5mm. In some embodiments, ID2 may be less than about 4mm. In some embodiments, ID2 may be less than about 5mm. In some embodiments, ID2 may be less than about 6mm. In some embodiments, ID2 may be less than about 2mm. In some embodiments, ID2 may be greater than about 3mm. In some embodiments, ID2 may be greater than about 4mm. In some embodiments, ID2 may be greater than about 5mm. In some embodiments, ID2 may be greater than about 6mm.

[0210] In some embodiments, L1 may be less than about 5 cm. In some embodiments, L1 may be less than about 10 cm. In some embodiments, L1 may be about 5-10 cm. In some embodiments, L1 may be about 10-20 cm. In some embodiments, L1 may be about 20-30 cm. In some embodiments, L1 may be about 30-50 cm. In some embodiments, L1 may be greater than about 50 cm. In some embodiments, L1 may be greater than about 1 cm. In some embodiments, L1 may be greater than about 2 cm. In some embodiments, L1 may be greater than about 5 cm. In some embodiments, L1 may be greater than about 10 cm.

[0211] In some embodiments, L2 may be approximately 50-150 cm.

[0212] In some embodiments, ID1 and ID2 may be the same.

[0213] Fig.11E An embodiment of a catheter system is shown in which a vent lumen 1184 is in direct fluid communication with a fluid collection bag 1020. In this embodiment, a controller including sensing functionality may or may not be present. In this embodiment, air blockage is avoided by a vent lumen that uses a vent 1142 in the fluid collection bag to vent the urine drainage lumen 1012. The vent may additionally or alternatively be anywhere along the vent lumen. The vent lumen may extend part or all of the length of the drainage lumen. The urine drainage lumen is fluidly connected to the drainage bag at a connection point 1192, which may include a valve 1136. The vent lumen is connected to the drainage bag at a connection point 1194. In this embodiment, and possibly other embodiments, the fluid collection bag 1020 may include a rigid or semi-rigid portion 1196 to ensure that the fluid collection bag does not collapse around the connection point 1194. This embodiment may or may not include a valve 1186. The vent tube 1184 may be incorporated into the drainage tubing system, or may be an add-on piece that is connected at or near the barb of the Foley catheter and at the connection point 1194 to the drainage bag.

[0214] Fig. 12A Shown with Fig. 10A An embodiment of a sensing Foley catheter system similar to the sensing Foley catheter system shown in FIG. Fig. 10A In contrast to the system shown, no pressure bladder is utilized. Instead, pressure inside the bladder is measured via the urine cavity (or other cavity) in the sensing Foley catheter. In this embodiment, the pressure cavity 1202 is connected to the vent 1204 or elsewhere in the system external to the patient and is at least periodically in fluid communication with the drainage / urine cavity of the catheter. In this embodiment, the sensing Foley catheter system can be used with any standard Foley catheter. Note that any embodiment of the sensing Foley catheter system can be used with a standard Foley catheter. If pressure measurement in the bladder is not desired, then Fig. 12A The system shown can also be used without the pressure lumen 1202 and with a standard Foley catheter.

[0215] Some embodiments of the sensing Foley system are able to determine intra-abdominal pressure with a standard or off-the-shelf Foley catheter. In this way, the controller can be used with a standard Foley catheter and still incorporate IAP measurements into its analysis. In some embodiments, the controller can cause a pump to introduce air or bubbles into the drainage line of the Foley catheter. By measuring the pressure of the drainage line via a pressure sensor, the controller can determine at what point the bubbles of gas / air leave the Foley catheter and enter the bladder. The pressure required to push a fluid column containing bubbles into the drainage line will increase until the bubbles leave the drainage line. The pressure at which the bubbles leave the Foley catheter is equal to the intra-abdominal pressure. The fluid column can be solid or intermittent. The IAP measurement sequence can be performed by the controller on a regular basis. It can be performed before or after air lock clearing is performed. IAP measurements can also be done manually by physically looking at the pressure on a gauge similar to a blood pressure cuff. The vent can be closed before performing this type of IAP measurement. The gas may be sterile and / or may be sterilized by UV light during transport (eg, at the barb area).

[0216] In some embodiments of the sensing Foley system, an irrigation lumen may be included in the Foley catheter, or a separate irrigation catheter with an irrigation lumen may be used to irrigate the bladder. In these embodiments, the controller of the sensing Foley system may communicate with the irrigation pump so that the volume of the irrigation fluid may be subtracted from the measured fluid output volume to accurately determine the urine output (which does not include the irrigation fluid).

[0217] In embodiments where a standard Foley catheter is used with a sensing Foley system, a specialized clamp can be used to clamp one or more lumens of the drainage tube without clamping the urine drainage lumen of the drainage tube. The clamp can be configured to align the clamping mechanism with the drainage tube, for example to close the pressure lumen but not the urine drainage lumen of the drainage tube.

[0218] Fig. 12B An embodiment of a sensing Foley catheter system is shown that does not include measurement of IAP or temperature. Note that this embodiment still has the anti-gas lock feature.

[0219] Fig.13 Shown with Fig. 12A An embodiment of a sensing Foley catheter system similar to the sensing Foley catheter system shown in FIG. 1 is shown in FIG. 1 . In this embodiment, valve 1302 can be used to periodically close pressure chamber 1202 to the urine drainage chamber. The valve can be opened by a controller or manually when pressure measurements are being taken, and closed again by a controller or manually when bladder pressure readings are not needed.

[0220] Fig. 10A , Fig. 10Cand Fig. 12A Embodiments of sensing Foley catheter systems are shown that include a vent near the patient end of the drain tube that allows air to enter the drain tube if negative pressure is created either by a siphon in the drain tube or by a pumping mechanism, or both. Without the vent / filter, such negative pressure could result in aspiration injuries, such as damage to the mucosal lining of the bladder. Note that these embodiments differ from devices where the vent allows air to escape (but not enter) the drain tube.

[0221] The urine drainage lumen preferably has an inner diameter of less than about 0.25 inches so that the liquid in the lumen remains in contact with the circumference of the lumen, which forms a seal and allows the liquid to advance when the pumping mechanism is activated. There may be multiple drainage lumens to prevent blockage of flow when the pumping mechanism fails. In these embodiments, the drainage lumen is preferably normally empty, which may require continuous activation of the pumping mechanism. Alternatively, the pumping mechanism can be activated before the measurement of volume is made to ensure that all liquid is drained, which reduces the power requirements of the device.

[0222] Some embodiments of a sensing Foley catheter system include: detecting a pressure peak in a drainage line while pressure within a body organ remains constant; and using a pump to generate negative pressure through the drainage line until the pressure in the drainage line equals the pressure in the body organ.

[0223] In one embodiment, the vent has a resistance to air flow that is greater than the resistance to liquid flow from the patient, so that any accumulation of liquid in the patient is cleared into the drainage line before air enters through the vent. For example, in the case of urine drainage, the entire bladder will be emptied into the drainage line as long as the resistance to air flow through the vent is greater than the resistance of urine flowing through the patient's catheter before air enters through the vent. However, the vent preferably has the lowest possible resistance to air flow while meeting this need in order to minimize aspiration injuries.

[0224] In another embodiment, the vent has very little resistance to airflow so that the bladder is further protected from suction, and the controller pump is activated to clear the air lock at more frequent intervals (e.g., every 1 minute, every 5 minutes, or every 10 minutes) to keep the drainage line free of urine. When the pump is activated, it can continue to run until it detects that no more urine is being discharged, indicating that the bladder has been completely emptied. Alternatively, the pump can run for a set period of time, such as about 30 seconds, about 1 minute, about 3 minutes, about 5 minutes, or about 10 minutes. The controller pump can be inactive between intervals, or can create a "background vacuum" (negative pressure less than the air lock clearing pressure) between air lock clearing intervals.

[0225] The pumping mechanism used can be any suitable mechanism, including but not limited to peristaltic pump, diaphragm pump, vane pump, impeller pump, centrifugal pump or any other suitable pump. The pump can be powered by a wall socket, battery, manpower or any other suitable source. In certain embodiments, the vacuum is in the range of about 0 to -50 mmHg. Negative pressure can be provided alternatively by the wall vacuum often present in hospital rooms. The pumping mechanism can include a peristaltic pump or an aspirator directly applied to the collection container. The pump can be located on the patient side of the drainage reservoir, or the pump can preferably be located on the non-patient side of the drainage reservoir / cassette so that the reservoir is located between the patient and the pump. In order to operate correctly, the pump should preferably be able to generate a negative pressure equal to the maximum fluid column height in the drainage tube. This can be half the length of the drainage tube. In the case where the urine drainage tube has a maximum length of 60 inches, the maximum negative pressure required is about 30 inH2O, or 56 mmHg.

[0226] Other techniques may be used to push urine through the tube and / or system including pulsating mechanical, vibroacoustic, thermal, vibration, squeezing, rolling, or electromagnetic stimulation to cause at least one of movement of the drainage tube and the bodily fluid therein. In some embodiments, rolling stimulation includes sequentially compressing multiple cavities such that the cavities are never all compressed at the same time.

[0227] In another embodiment, the gas plug is removed with the aid of a collapsible drain tube that resides in a stiffer, kink-resistant tube. Fig.14A Such an embodiment is shown in its uncollapsed form. The inner collapsible drain tube 1402 is inside the outer anti-kink tube 1404. Fig. 14B An embodiment is shown in which the inner collapsible tube is collapsed. Periodically, the drainage tube is collapsed, such as by applying positive pressure to the space between the collapsible tube and the anti-kink tube or by applying negative pressure to the interior of the collapsible tube. The collapse of the drainage tube then pushes urine away from the patient and toward a collection container.

[0228] In another embodiment, the drainage lumen clearing mechanism comprises a tube having an inner diameter of less than about 0.25 inches, so that no air pockets can move up the length of the tube. This is possible due to surface tension in the smaller tube, which prevents the movement of the fluid when one end of the tube is closed to the atmosphere (as in the case of a bladder). Therefore, the drainage tube is always full of urine, and for each volume of urine produced, the same volume of urine must leave the drainage tube because urine is incompressible. In another embodiment, the inner diameter is less than 0.125 inches. In another aspect, the drainage tube acts as a siphon and provides a small safe amount of vacuum to the bladder. Alternatively, using a small lumen drainage tube, air is allowed to periodically enter the lumen through a vent / valve. The negative pressure generated by the pump can encourage this. Due to the negative pressure generated by the pump, urine is encouraged to continue to flow into the collection container, thereby preventing air locks.

[0229] Compared with the prior art, the use of small diameter tubes also results in a smaller amount of residual urine in the drainage tube. It is preferred to have a smaller residual volume because it allows urine to move from the patient's bladder to the collection container faster. In order to measure the urine produced recently, the speed of this delivery is very important. This is especially important for patients with a low rate of urine production because it takes even longer time to transport their urine from the bladder to the collection container. For example, for patients who only produce 10mL / hr of urine (approximately 40ml residual volume) using a standard drainage tube, measuring their urine in the collection container will lag behind the real urine production by 4 hours. On the contrary, using a smaller tube (such as a tube with approximately 5ml residual volume), the measurement only lags behind the real production by 30 minutes. In some embodiments, it is not necessary to utilize a small diameter cavity, a pump with or without a vent / valve to provide negative pressure to the drainage line.

[0230] Fig.15Embodiments of devices that are well suited for draining chest tubes or other drainage tubes that apply constant negative pressure to patients are shown. However, these embodiments are also suitable for draining urine from the bladder or fluids from other cavities. Any features disclosed in connection with chest tube drainage can also be applied to bladder drainage or other body cavity drainage. Liquid is discharged from the patient through a drainage tube 1585 connected to a collection container 1582. Drainage is aided by drawing negative pressure on the collection container 1582 (e.g., by connecting a suction tube 1583 to a hospital wall aspirator). Suction can also be applied by other methods (such as with a pump as disclosed elsewhere herein). Air enters the drainage chamber 1585 through a valve 1584, which has a bursting pressure equal to the desired negative pressure. By selecting the correct bursting pressure (e.g., -15 to 0 mmHg or -10 mmHg), the pressure applied to the patient will remain at that pressure as long as the hospital wall aspirator / pump can produce enough suction at the collection container 1582. Preferably, the drainage lumen for draining the chest tube is as large as possible while maintaining the siphon. Suitable inner diameters include, but are not limited to, about 1 / 4", about 5 / 16", or about 3 / 8".

[0231] Fig.16 Another embodiment of a device well suited for draining a chest tube or other drainage tube that applies a constant negative pressure to a patient is shown. Fluid is drained from the patient through a drainage lumen 1688, and negative pressure is applied using a pumping mechanism 1686. A pressure sensor 1687 resides within the drainage tube at the patient end and thereby measures the pressure applied to the patient. The measurements obtained by the sensor 1687 are sent back to a controller that controls the pumping mechanism 1686, and the pressure generated by the pumping mechanism 1686 is adjusted so as to maintain the pressure at the sensor 1687 (and the patient) at a desired level. The pressure sensor 1687 may also be located elsewhere in the system. The sensor may also be used to passively monitor the pressure at the patient end of the catheter to provide information to the clinician regarding the level of suction being applied. Although Fig.16 The pump is shown on the patient side of the drainage reservoir, but the pump may alternatively be on the other side of the drainage reservoir so that the reservoir is between the patient and the pump.

[0232] In another embodiment of the present invention for draining chest tube, the volume of the fluid drained is measured to provide information about the drainage status of the chest tube to the clinician. This measurement can be accomplished by any suitable means, particularly those described for measuring urine volume.

[0233] In addition to eliminating air locks, several air lock removal designs detailed above have been found to effectively remove sediment and blood clots from urine drainage lines. These problems plague current urine drainage tubes, particularly those with smaller lumen drainage tubes and monitoring technology at the drainage bag, and the present invention provides an advancement in the current state of the art by automating the removal of these drainage obstruction debris and clots. This feature is particularly useful when used in conjunction with pressure sensing when pressure sensing is either in the bladder capsule at the top of the Foley or when communicating with the bladder fluid. This allows monitoring of pressure and vacuum in the bladder, and allows more aggressive pumping based on actual bladder pressure until clots / obstructions are cleared. In the absence of this pressure / vacuum sensing, the pumping of fluid in the drainage tube may produce clinical sequelae in the bladder, such as aspiration trauma, due to exposure of the bladder mucosa to excessive vacuum.

[0234] exist Fig.17 In another embodiment shown in FIG. 1 , a gas sampling chamber 1790 extends along the length of the drainage tube and terminates in a gas permeable but liquid impermeable filter 1791 that remains in contact with the urine, with its meniscus 1792 further away from the patient than the filter. When measurement of oxygen, carbon dioxide, or any other gas is desired, the air within the gas sampling chamber 1790 is drawn into the base 1789 of the drainage device for analysis. This configuration allows for accurate gas analysis even for embodiments of the device that allow air to enter the drainage line, such as in FIG. 10A to FIG. 16 The device for the drainage line is shown in .

[0235] like Fig.18 As shown, the active exhaust system includes a vent 1802, a drainage line 1804, a collection container 1806 and a pump 1808. The exhaust side of the drainage line is connected to the patient. In one embodiment, the fluid discharged is urine, and a connection to a urinary catheter is established. The fluid flows from the patient's body through the drainage line and is collected in the collection container. The pump in this embodiment does not act directly on the drainage line, but rather draws a vacuum on the collection container. The pump facilitates drainage by drawing a negative pressure on the collection container, which pushes the fluid through the drainage line. Preferably, the collection container is rigid so as to maintain a constant volume when the pump applies a negative pressure. The vent on the patient side of the drainage tube is preferably a vent that allows the transmission of gas (preferably air) but prevents the transmission of liquid. Therefore, the vent prevents considerable negative pressure from being applied to the patient by allowing the atmosphere to enter the system. This mechanism prevents suction damage, such as at the bladder wall.

[0236] The pump in the system can be any suitable pump for pumping gas, including but not limited to a peristaltic pump, a diaphragm pump, or a centrifugal pump. In order to operate correctly, the pump should preferably be able to generate a negative pressure equal to the maximum fluid column height in the drainage tube. This can be half the length of the drainage tube. Using a urine drainage tube with a maximum length of 60 inches, the maximum negative pressure required is about 30inH2O or 56mmHg.

[0237] like Fig.19 As shown, the active ventilation system for discharging body fluids can have additional vents. One such vent (vent 1962) can be located on the collection container and allow air to escape the collection container. This prevents the accumulation of pressure when new fluid enters the container by allowing each volume of fluid entering the system to be offset by the same volume of air leaving the system. Another such vent (vent 1964) can be located between the collection container and the pump. The vent allows the transmission of gas (preferably air) but prevents the transmission of liquid to prevent bacteria or viruses from entering or leaving the collection container and the drainage tube. Preferably, the vent is sterile grade, meaning that the air passing through is considered to be sterile. The vent (not shown here) may or may not be present at the patient end of the drainage line.

[0238] like Fig. 20 As shown, pressure offset can be achieved with a single vent on the collection container. In this case, the vent (vent 2072) can be between the collection container and the pump as previously described, but an additional valve 2074 allows air to escape the collection container in the presence of positive pressure. The valve is preferably a one-way valve that allows air to leave but not enter the system. When the pump is started, the one-way valve closes and air must be drawn from the collection container, thereby creating a negative pressure in the collection container and facilitating the flow of fluid through the drainage line. The vent may or may not be present at the patient end of the drainage line (not shown here).

[0239] Detecting infection

[0240] Fig.21The embodiment of the collection container, chamber or cassette that can be included in the sensing Foley catheter system to detect bacteria, blood and / or other substances in urine using UV / light / Raman spectroscopy is shown.Cassette 2100 includes container wall 2102, which is preferably rigid. Urine 2106 is collected in the cassette. If urine is collected too fast or there are some obstacles to the emptying of the cassette or emptying is fast enough (for example, in the case of high urine flow), overflow area 2104 will allow any excess urine to be discharged from the cassette.Cassette 2100 can include an optically transparent portion 2110 preferably merged into the outer wall of the cassette and a reflector portion 2112 preferably on the inner wall of the cassette or merged into the inner wall of the cassette. "Optically transparent" means here that light at the desired analytical wavelength can be transmitted through the optically transparent portion. Preferably, the optically transparent portion is made of a material (such as polymethyl methacrylate, polystyrene, acrylic acid, quartz, etc.) that can transmit UV light. The wall thickness may need to be thin enough to allow appropriate UV wavelengths to be transmitted through the optically transparent portion. For example, the thickness of the optically transparent portion may be from about 0.5 mm to about 0.7 mm thick. Alternatively, the thickness of the optically transparent portion may be from about 0.5 mm to about 0.6 mm thick. Alternatively, the thickness of the optically transparent portion may be from about 0.6 mm to about 0.7 mm thick. Alternatively, the thickness of the optically transparent portion may be less than about 0.7 mm thick.

[0241] The UV / light emitter / receiver 2108 transmits UV or other wavelengths of light in the appropriate wavelength through the optically transparent portion 2110, through the urine in the box, to the reflector 2112 in the box. The UV / light emitter / receiver can be incorporated into or connected to the controller component of the sensing Foley catheter system. The light is reflected back to the UV / light receiver, which then transmits the collected data to the controller for signal analysis. More than one UV / light wavelength can be analyzed either simultaneously or continuously. In addition to light in the UV range, light outside the UV range can also be used. In order to reflect the concentration of one or more substances in the urine The signal is stronger, the volume of urine between the transmission and reception of light is preferably physically maximized. The transmitter / receiver can be as Fig.21The cassette may be positioned as shown, or in other areas of the cassette. The receiver may be in a different position from the transmitter, and the reflector may be necessary or may not be necessary or may not exist. Because the urine in the cassette is frequently emptied, the UV / light absorption measurements can be collected over time, and the increase and / or decrease in the level of one or more substances in the urine can be tracked substantially or almost in real time over time. This is particularly important in the rapid identification of infections, including urinary tract infections and catheter-associated urinary tract infections (CAUTIs). UV / light detection can also be performed elsewhere in the sensing Foley catheter system, including in the drainage tube, a separate sampling area, etc.

[0242] Infection can be identified by analyzing urine using UV / light spectroscopy for bacteria, red blood cells, plasma, and / or white blood cells. Fig.22A Various absorption wavelengths of light by E. coli, red blood cells and blood plasma in urine are shown. The presence of blood plasma / white blood cells and / or bacteria in urine are all indicators of infection. The presence of red blood cells may not indicate infection. Therefore, it is desirable to distinguish red blood cells and bacteria / plasma / white blood cells in urine. Because the spectral identification mark of red blood cells is obviously different from the spectral identification mark of either bacteria or blood plasma / white blood cells, at a wavelength of about 414nm, the signal of red blood cells can be separated from the signal of bacteria and / or blood plasma / white blood cells, and infection can be identified by analyzing the light absorption at this wavelength. Because the identification marks of blood plasma and bacteria are different from each other at wavelengths of 260nm and 280nm, these wavelengths can be used to distinguish blood plasma and bacteria. However, it is possible that blood plasma and bacteria are present during infection.

[0243] Broad spectrum spectroscopy can be used over the entire continuous range of wavelengths and over time. The signal can be deconvoluted or demixed to determine the amount of analyte and / or form the basis of a signature upon which an analysis algorithm is developed.

[0244] Other wavelengths and other techniques can also be used to detect various substances in urine or any collected / discharged body fluids. UV / light absorption can also be used to detect turbidity. Dyes or drugs or active substances can also be introduced into the system or coated on the inside of the system, cassette, etc. to react with the substances in the urine to help analyze. Any type of sensor can be used to sense any substance or quantity of the collected urine on a real-time basis, either intermittently or continuously. For example, a sensor that detects magnesium in urine can be used to diagnose pre-eclampsia or eclampsia. Lactate sensors can be used to test lactate (or lactate dehydrogenase) in urine. The identification of lactate in urine can be an early indicator of sepsis. Lactate sensors can include enzyme lactate sensors. For example, lactate sensors as disclosed in Weber (Weber J, Kumar A, Kumar A, Bhansali S., "Novel lactate and pH biosensor for skin and sweat analysis based on single walled carbon nanotubes" (Sens. Actuators, B, Chem. 2006; 117: 308-313)) and / or Mo (Mo, JW, Smart, W, "Lactate biosensors for continuous monitoring" (Front Biosci. 2004 Sep 1: 9: 3384-91)) can be used, both of which are incorporated herein by reference in their entirety.

[0245] Visible wavelengths may also be used. For example, a camera that captures visible light may be used to monitor urine collected over time. The image collected by the camera may be analyzed for color wavelength, turbidity, intensity of color, consistency or inconsistency of color and / or intensity and / or turbidity, turbidity, the presence of blood or clots, hemolyzed blood, bubbles, proteins, etc. Because the image of urine may be captured in substantially any time increment within hours or days, urine may be monitored for the presence or absence of factors indicating the patient's condition or for changes that may represent the patient's condition. For example, some conditions that may be identified include dehydration (based on how yellow the urine is), hemorrhage (based on the presence of blood), protein in urine (based on bubbles in urine), and injection (based on turbidity, bubbles, color, turbidity, etc.). When the camera is used to assess the properties of urine collected over time, it may be important to assess a smaller amount of urine recently collected so that the urine is not diluted by older collected urine. This may provide feedback in real time on the patient's state. To accomplish this, the camera may be pointed at urine in an inlet portion of the cassette 2100, such as in a lower portion of the drainage tube or in an upper portion of the cassette or where the drainage tube connects to the cassette.

[0246] Reference colors can be included in the system (e.g., in the cassette) to calibrate the camera to the baseline red, blue, and green. For example, reference areas of red, green, and blue (such as reference stickers with red, green, and blue areas) can be placed near the camera (either inside or outside the cassette) and on the opposite side of the cassette so that the camera can see both. The near reference point calibrates the camera to the color without any urine present, and the far reference point is the same color seen by the camera through urine.

[0247] Image processing of images collected by the camera / wavelength detector can be performed by the controller. Possible image processing steps include classification, feature extraction, multi-scale signal analysis, pattern recognition, projection, edge or boundary detection, anisotropic diffusion, hidden Markov model, image editing, image restoration, independent component analysis, linear filtering, neural networks, partial differential equations, pixelation, principal component analysis, self-organizing maps, wavelets, filtering, denoising, edge enhancement, contrast enhancement, morphology, dilation, erosion, Fourier transform, etc.

[0248] When the camera detects anything outside of a preset range (for example, when the color of the urine is outside of a normal range, or when the inclination of the system is outside of an acceptable range, when the system changes inclination more frequently than a preset frequency, or when the turbidity of the urine is outside of a normal range, or when blood or other abnormal entities are detected in the urine, etc.), the controller can alert the user.

[0249] In the embodiment that visible wavelength camera is used, the live or semi-live feed of urine in the system can be projected remotely.For example, the view of urine reservoir / cassette can be projected on a table, computer, phone, monitor either in the room or elsewhere.This feature can allow hiding of urine in the reservoir and / or urine bag near the patient, which is more pleasant for the patient and his / her visitor.In other words, real urine near the patient can be hidden or covered with opaque material, and the image feed of urine is presented in other places.Urine in any one or all of cassette, drainage tube, urine bag etc. can be hidden by opaque material.

[0250] Fig. 22B An embodiment of a display 1110 on the controller / monitor 1018 is shown, which includes current values ​​and past trends for IAP, temperature, urine output, and urine color. Urine color can be detected by a camera disclosed herein. Although this figure shows black, white, and grayscale colors, real colors can be displayed, including yellow, orange, red, etc. Settings 2202 can be used to show different historical ranges of data, including 1 hour, 6 hours, 12 hours, 24 hours, etc.

[0251] Note that the embodiments disclosed herein show user interface displays on controllers / monitors. However, a display or a component of a display or an aggregate display may be additionally or alternatively displayed on a computer, a mobile computer, a mobile phone, a tablet computer, a separate monitor / screen, etc. For example, a portion of a display may be shown on a portable tablet computer, where the tablet computer may be used alone or docked to a controller / monitor. A tablet computer, phone, or other device may be synchronized with a controller by proximity, using RFID, etc. The display may show information related to an individual patient, and / or it may display information related to more than one patient, for example, at a nurse's station. The display may show data for several patients individually, or may show aggregated data from more than one patient. The display may also incorporate several different screens, which may be accessed by switching between screens. Some screens / displays may require management login credentials, for example, to adjust the settings of the Foley system.

[0252] RFID or other mechanisms may also or alternatively be used to prevent the use of unauthorized "knock-off" disposable parts of the system. In this way, the controller / monitor may identify the disposable parts of the system as authorized or unauthorized. The system may warn the user and may not work on unauthorized disposable parts. Similar ID mechanisms may be used to control the features of the system. For example, a user may have paid a subscription fee to access the IAP function of the system. The same disposable unit may be used for those who have subscribed and those who have not subscribed to the IAP feature, but the controller may be programmed to reflect the subscription details, and the ID mechanism will allow the disposable IAP feature to work for those who have subscribed to the feature. The ID mechanism may not allow the IAP feature to work for those who have not subscribed to this feature. Or alternatively, the controller may allow the feature to work once or a limited number of times for those who have not subscribed to the feature.

[0253] Appropriate sensors can be used to detect drugs or drug residues in collected urine. Other substances or characteristics of collected urine that can be detected include color, clarity, odor, specific gravity, weight gram molecular osmotic pressure concentration, pH protein, glucose, creatinine, nitrite, leukocyte esterase (WBC esterase), ketones, red blood cells or white blood cells, casts, crystals, bacteria, yeast cells, parasites, squamous epithelial cells, etc.

[0254] CAUTI or infection can be identified and / or reduced by several methods, including: analyzing urine using spectroscopy, light wavelength analysis, etc. to identify contaminants at an early stage, reducing damage to the bladder caused by suction, reducing urine retention in the bladder, reducing the presence of bacteria or microorganisms by using antimicrobial coatings or embedding materials (such as silver or other materials), increasing the accuracy of pressure measurements within the bladder by reducing suction within the bladder, and increasing the accuracy of urine output measurements by reducing air locks in the system and suction within the bladder. The pressure peak caused by suction within the bladder can be defined as a pressure reading below about -20 mmHg. Alternatively, the pressure peak caused by suction within the bladder can be defined as a pressure reading below about -10 mmHg to about -20 mmHg. Alternatively, the pressure peak caused by suction within the bladder can be defined as a pressure reading below about -10 mmHg.

[0255] CAUTI can also be reduced by using UV light or light or radiation of any effective wavelength to reduce bacteria in the urine and / or system. Urine can be treated with UV light, which disinfects urine in the cassette or elsewhere in the system. For example, UV light can be applied as urine enters the cassette (e.g., Fig.101AThe urine is sterilized at the entry point valve 10104 shown, either within the cassette or above the cassette (e.g., in a drainage tube above the cassette).

[0256] Fig.23 An embodiment of a cassette is shown that includes a baffle or flap 2302. The baffle / flap is to prevent urine from wicking along the inner wall of the cassette as shown by the dashed arrows. The baffle will prevent urine from wicking past the point of the baffle, so the urine will fall back into the measurement reservoir below.

[0257] Filling

[0258] One aspect of the disclosed technology that is particularly advantageous in achieving a high resolution signal involves adjusting and maintaining a balance of pressure on either side of a pressure interface represented by a membrane of a pressure sensing bladder from which pressure distributions from specific physiological sources such as peritoneal pressure, respiratory rate and heart rate, relative lung tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume can be monitored. This balance of pressures can be referred to as a pressure differential. In some embodiments, the preferred pressure differential is at or around about zero. In some embodiments, the preferred pressure differential can be different values. The pressure impinging on the outer surface of the bladder (the inner side facing the bladder) is subject to variation depending on the patient's physiology. The pressure on the inner surface of the bladder (which is in fluid communication with the fluid column) is subject to reduction due to fluid leakage and imperfect sealing.

[0259] Upon initial insertion of a sensing Foley catheter, external pressure is typically applied to the fluid column and against the pressure interface to achieve a first approximation of the pressure applied on the pressure interface from within the bladder. The pressure signal as measured across the pressure interface has a maximum amplitude when the pressure differential is approximately zero. Therefore, the amplitude of the pressure signal can be used to adjust the pressure applied from the fluid column against the pressure interface. This process of applying an appropriate amount of pressure against the interface may be referred to as filling the fluid column or filling the bladder. As described above, because the pressure on either side of the pressure interface may change, the fluid column may need to be refilled or readjusted from time to time. The necessity for refilling can be monitored by testing small changes in pressure in order to achieve the maximum amplitude of the pressure signal profile. Alternatively, filling may occur automatically on a periodic basis by a controller.

[0260] Embodiments of the disclosed systems and methods include automatic pressure regulation by a controller. Thus, the regulation system can detect an optimal target pressure and volume to inflate the balloon by monitoring the sensed pressure signal and adding or removing air or fluid volume as needed. For example, upon insertion of the catheter, a pressure regulation loop that regulates the balloon volume and pressure can inflate the balloon until it detects a pressure rate that originates from physiology. Upon sensing the rate, the pressure regulation controller can add or subtract trace amounts of air in a routine or programmed sequence of steps until the amplitude of the sensed wave is maximum. The control feedback loop between the optimally regulated pressure (expressed as balloon pressure and volume) and the sensed physiological pressure distribution is iterated continuously and / or as needed to ensure high-fidelity measurement of physiological data. In some embodiments, automatic pressure regulation can be performed in a noticeable background while physiological data is transmitted and displayed; in other embodiments, the system can pause the transmission of physiological data during the pressure regulation sequence.

[0261] Embodiments of the disclosed technology include a gas delivery system that can deliver gas during a filling operation, whereby pressure can be applied to a fluid column proximal to the proximal-facing side of a pressure interface. A source of gas (such as compressed air) or liquid is held in a tank. Using CO 2 As an example, CO 2 The gas is controllably released from the tank through a pressure regulator that can gradually reduce the pressure in the tank (e.g., a pressure of about 850 psi) to a range of about 1 psi to about 2 psi. The released gas passes through a filter and a pressure relief valve set at about 2.5 psi. The pressure relief valve is a safety feature that prevents gas from passing at levels greater than 2.5 psi in the event of a failure of the upstream regulator. The CO leaving the pressure relief valve is 2 The bag including the pressure sensing interface is then filled through the first solenoid-controlled filling valve to enter the catheter line. The pressure in the bag is allowed to rise to a level of up to 30 mmHg, at which time the first solenoid-controlled valve is closed. A second solenoid-controlled valve distal to the first valve operates as a relief valve that can release pressure from the catheter to a target pressure. Alternatively, the relief valve can be activated until a respiratory waveform is detected, after which the bag will be optimally filled and the valve will be closed. The relief valve can be operable to be proportionally controlled based on voltage or pulse width modulation (PWM), which allows the discharge rate to be slow enough so that the target pressure is reached and the valve can be closed before overshoot. Alternatively, a peristaltic pump or other air pump can be used to fill the bag with room air.

[0262] Fig.24A graph is shown representing a method of filling a pressure bladder in some embodiments. Here, a small volume burst of fluid (approximately 0.3cc) is added to the pressure sensing bladder and the pressure within the bladder is measured. The small volume burst of fluid is introduced until the measured pressure within the bladder stabilizes to a stable pressure 2401. This transition is shown at the inflection point 2402. The volume burst is introduced through this point until the measured pressure begins to increase rapidly (for example, if the slope 2404 of the curve is greater than about 2mmHg / 10ms). The inflection point is shown at 2406. At this point, the pressure within the bladder drops to a pressure around or slightly above the stable pressure 2401. In some embodiments, this pressure represents the initial pressure measurement pressure. This process is also shown in FIG. Fig. 27 It is represented in the flowchart in.

[0263] Alternatively, filling of the pressure bladder may involve pressurizing the pressure bladder to well above zero mmHg, then removing a small amount of air / gas / fluid and monitoring the pressure bladder pressure. The pressure bladder pressure will stabilize or reach a plateau as it approaches an optimal filling pressure. To determine this optimal pressure, pressure measurements are taken when a small amount of air is removed from the pressure bladder, and when subsequent pressure measurements are substantially the same (within approximately 2 mmHg of each other), the bladder is at the optimal filling pressure. If the 2 subsequent measurements are not substantially equal, the pressure bladder is re-pressurized to well above zero mmHg and the process is repeated. Pressure measurements taken when a small amount of air is removed from the pressure bladder may be taken within approximately 5 to approximately 15 seconds to compensate for the effects of breathing on the pressure measurement. In some embodiments, the pressure signal may require a short stabilization period after a small amount of air / gas / fluid is removed from the pressure bladder before a pressure measurement is taken.

[0264] A micro-burst of fluid may be from about 0.2cc to about 0.4cc. A micro-burst of fluid may be from about 0.1cc to about 0.5cc. A micro-burst of fluid may be up to about 0.5cc. A micro-burst of fluid may be up to about 1.0cc.

[0265] Fig.25 A graph showing a method of filling a pressure bladder in some embodiments is shown. This method is similar to Fig.24 except that the pressure increases more smoothly within the pressure sensing capsule without Fig.242505. This transition is shown at inflection point 2506. The bladder pressure increases past this point until the measured pressure begins to increase rapidly (e.g., if the slope 2510 of the curve is greater than about 2 mmHg / 10 ms). This inflection point is shown at 2508. At this point, the pressure within the bladder decreases to about or slightly above the stable pressure 2505. In some embodiments, this pressure represents an optimal or initial pressure. This process is also shown in FIG. Fig.28 It is represented in the flowchart in.

[0266] Fig.26 A flow chart of a balloon filling process according to certain embodiments of the present invention is shown. Embodiments of the disclosed systems and methods include automatic pressure regulation by a controller. Thus, the regulation system can detect the optimal target pressure and volume to inflate the balloon by monitoring the sensed pressure signal and adding or removing the amount of air as needed. For example, upon insertion of the catheter, a pressure regulation loop that regulates the balloon volume and pressure will inflate the balloon until it detects a pressure rate that originates from physiology. Upon sensing the rate, the pressure regulation controller can add or subtract a trace amount of air or fluid (approximately 0.3cc) in a routineized sequence until the amplitude of the sensed wave is maximum. The control feedback loop between the optimally regulated pressure (expressed as balloon pressure and volume) and the sensed physiological pressure distribution is iterated continuously and / or as needed to ensure high-fidelity measurement of physiological data. In some embodiments, automatic pressure regulation can be performed in an apparent background while physiological data is transmitted and displayed; in other embodiments, the system can pause the transmission of physiological data during the pressure regulation sequence.

[0267] The trace amount of air or fluid can be from about 0.2cc to about 0.4cc. The trace amount of air or fluid can be from about 0.1cc to about 0.5cc. The trace amount of air or fluid can be up to about 0.5cc. The trace amount of air or fluid can be up to about 1.0cc.

[0268] In some embodiments, the filling of the bladder can be based on the characteristics of the system. The pressure bladder can be inflated 1, 2, or more times to characterize the system, including the ultrasonic transducer, the pressure pump, the resistance in the system, the pressure bladder, etc. The pressure bladder can be pressurized within a range of pressures to determine the characteristics of the specific system at that point in time. This information is then used to optimize the inflation pressure of the pressure bladder.

[0269] Loop Controller

[0270] Certain patient parameters measured by sensing Foley catheter systems and by other means are affected by and / or affect the treatment a patient is receiving through a medical device.

[0271] The loop controller may be integrated with the controller of the sensing Foley catheter system (either in the same device or in a separate device) to interpret patient parameters to control the patient's medical treatment.

[0272] For example, IAP can be used to control IV infusion rate. If IAP becomes too high, the infusion rate can be reduced or stopped until IAP returns to an acceptable range. IAP combined with relative stroke volume and / or stroke volume variability (variability in the size of the heart pulse seen in the bladder, etc. during the respiratory cycle) can allow for excellent control of IV fluid or blood product infusion using IAP as an indicator of excess fluid and relative stroke volume increase and decrease of stroke volume variability as an indication of additional fluid being required. Urine output can be further added to the control loop, which provides an indication that the fluid state has been restored with the return of urine output. Heart rate combined with respiratory rate can be used to control drug infusion (drug type, infusion rate, frequency, dosage, etc.). In this way, drugs can be used to make the patient reach a more stable condition determined by heart rate and respiratory rate. IAP and respiratory rate can also be used to control a mechanical ventilator or respirator. When IAP increases, the positive end expiratory pressure (PEEP) delivered by the mechanical ventilator should also increase to overcome the pressure. Indications of hypoventilation can be seen in tissue oxygenation and / or natural respiratory rate, which can be considered as signals that form the basis of mechanical ventilation. This signal can be either extracted during mechanical ventilation, or preferably, the loop controller can pause the mechanical ventilator to allow more precise and accurate detection of the basic respiratory rate / respiratory drive. The IAP, tissue oxygenation and / or respiratory rate can be used to warn the provider of the deterioration of the patient's condition and / or can be used to provide automatic adjustment of ventilator settings (including respiratory rate, PEEP, inspired % O2 and other settings). In an ideal situation, these parameters can be used by the loop controller to monitor and control treatment in a manner informed by machine learning and algorithm adjustment. These are just a few examples, but many combinations exist. One or more parameters can be used to control one or more therapeutic devices.

[0273] Fig.29 An embodiment of a loop controller in a patient environment is shown. In this example, the loop controller receives patient parameter inputs from a sensing Foley catheter 2902. The sensing Foley catheter resides in the patient's bladder 2904 and includes a retaining balloon 2908 and a pressure sensing balloon 2910. The sensing Foley catheter may include other sensors as disclosed herein.

[0274] The sensing Foley catheter 2902 includes a holding balloon inflation chamber, a pressure balloon sensing chamber, and a urine chamber. The pressure sensing balloon 2910 is connected to the pressure sensing chamber, which is connected to a pressure transducer 2920, which can be incorporated into a controller 2928. The urine chamber is connected to a urine output tube 2912. The urine output tube empties into a urine reservoir 2914, which can be connected to a urine volume measurement device 2916, or can be incorporated into a controller as disclosed herein. In addition, the urine output can be controlled by a urine pump 2918, which can be located on the urine drainage tube, or can be incorporated into the controller, or can be located on the non-patient side of the controller, as disclosed elsewhere herein.

[0275] The patient is shown with a respirator mask 2922 which is fed by a respirator tube 2924. The flow and composition of the breathing gas is controlled by a respirator 2926.

[0276] The loop controller 2928 is connected to the urine volume measurement device 2916, the urine pump 2918, the pressure transducer 2920, and the ventilator 2926 via connectors 2930, 2932, 2934, and 2936, respectively. The connectors may be wired or wireless. Alternatively, in this and other embodiments, some or all of the urine volume measurement device 2916, the urine pump 2918, and / or the pressure transducer 2920 may be incorporated into the controller 2928.

[0277] In this example, the circuit controller 2928 receives patient parameter inputs from the urine volume measurement device 2916 and the pressure transducer 2920, and using the information provided by these parameters, can control the urine pump 2918 and the ventilator 2926. Some of the parameters that the circuit controller can receive from the sensing Foley catheter include IAP, respiratory rate, heart rate, stroke volume, tissue oxygenation, tissue perfusion pressure, temperature, urine analyte, urine output rate, and other parameters, including those disclosed herein.

[0278] For example, if the loop controller receives parameter information indicating that the patient's IAP is elevated, the loop controller can control the ventilator perfusion rate, pressure, or other parameters. The loop controller can combine data from one or more input parameters and control one or more therapeutic medical devices. For example, based on the received elevated IAP and abnormal tissue oxygenation parameters, the loop controller can control the output of the ventilator 2926 and the urine output rate by controlling the urine pump 2918.

[0279] The loop controller continues to monitor the patient parameters and adjusts the therapeutic medical device accordingly. When the patient parameters are normalized, the control of the therapeutic medical device is adjusted accordingly, so that the feedback loop controlled by the loop controller can be a closed loop. The loop can also be adjusted manually when necessary, in which case the loop can be an open loop or a semi-closed loop.

[0280] Fig.30 Another example of a loop controller in a patient environment is shown. In this example, the patient has an intravenous (IV) line 3002 in a blood vessel in an arm. An IV fluid bag 3004 is raised to allow IV fluid to drip and / or flow into the patient through the IV line 3002. Valve 3006 controls the flow rate of the IV fluid into the patient by allowing the fluid to flow freely, restricting flow, or stopping flow. Here, valve 3006 is controlled by loop controller 2928 via connection 3008. The IV fluid bag 3004 can contain hydration fluid and / or medication. One or more IV bags can be involved, and one or more valves can control the IV bag. The loop controller can control the flow and content of the IV fluid to the patient based on the patient parameters received by the loop controller.

[0281] Fig.31 Another example of a loop controller in a patient environment is shown. In this example, the patient has a fluid drainage line 3102 inserted into the abdomen. Fluid from the abdomen can flow from the patient to a container 3104. The flow of fluid can be controlled by a pump 3106, which is controlled by the loop controller 2928 via a connection 3108. The loop controller can control the flow of fluid from the patient to the container 3104 via the pump 3106 based on received patient parameters. For example, if the IAP is abnormally high, the loop controller can increase the rate of fluid removal from the patient or initiate fluid removal from the patient by controlling the pump 3106.

[0282] Fig.32 Another example of a loop controller in a patient environment is shown. In this example, the patient has an intravenous (IV) line 3202 in a blood vessel in an arm. A drug infusion device 3204 controls the flow rate of the drug into the patient through the IV line 3202. More than one drug infusion device can be used. Here, the drug infusion device 3204 is controlled by the loop controller 2928 via connection 3206. The drug infusion device 3204 can contain any suitable fluid and / or drug. The loop controller can control the flow and content of one or more drugs to the patient based on the patient parameters received by the loop controller.

[0283] These examples show some medical devices that may be controlled by the loop controller, but any medical device may be used.

[0284] Fig.33 Detailed diagram of loop controller. Loop controller 2928 can receive one or more patient parameter inputs from sensing Foley catheter or other equipment. These inputs include but are not limited to urine output volume and rate, pressure distribution from bladder and sensor information from sensing Foley catheter or other equipment. Pressure distribution information from bladder can be further analyzed to determine IAP, respiratory rate, heart rate, stroke volume, sepsis index, acute kidney injury (AKI) index and other patient parameters. This analysis can be performed in loop controller 2928 or in a separate controller, and the separate controller is either connected to the loop controller by wired connection or by wireless connection. Connection can be through the Internet, intranet, WAN, LAN or other network, or it can be local through Bluetooth, Wi-Fi, etc.

[0285] The loop controller receives one or more inputs and analyzes the data to determine whether the medical device controller needs to be changed. One or more medical devices can be controlled to bring the patient parameters into the target range. Once the patient target range is reached, the loop controller can place the controlled medical device back into the standard state. The standard state will be different for each medical device and may also be different for each patient. The patient parameter target range is also different for each patient and is also different for the patient state. For example, the ventilator rate target range can be different depending on whether the patient is taking sedatives.

[0286] Embodiments of the technology can also automatically adjust the intravenous fluid or drug infusion rate based on feedback from the sensed cardiac output or respiratory rate. In one such embodiment, if the respiratory rate drops too low, the patient-controlled analgesia pump can be deactivated. Respiratory depression can be fatal in this group, and this protective measure can prevent overdose. The automatic feedback system may also be advantageous in large-volume resuscitation processes, where fluid infusion can be adjusted based on intra-abdominal pressure to prevent abdominal compartment syndrome by sounding an alarm and slowing the infusion rate when the intra-abdominal pressure rises. Yet another automatic feedback feature can provide direct feedback to the ventilator system to provide the optimal pressure of ventilation gas. In the context of increased abdominal pressure, general ventilator settings do not provide adequate breathing for the patient. Automatic adjustment of ventilator settings based on intra-abdominal pressure feedback according to this embodiment can advantageously provide optimal patient ventilation. Embodiments of the technology can also be applied as corrections in the application or understanding of other diagnostic measurements. For example, in the context of elevated intra-abdominal pressure, central venous pressure may suddenly become distorted. Providing direct access to these data through a central venous pressure reporting system allows automatic correction and accurate reporting of this key physiological parameter. Embodiments of the technology may also be used in a variety of other ways to automate therapy, including infusing fluids that may also include active agents (such as pressors or diuretics) in response to increased or decreased cardiac output or other parameters.

[0287] Other inputs and outputs to the circuit controller may include nutrition provided via a feeding tube or intravenously, wound drainage, fecal output, wound drainage, chest drainage, sweat output, respiratory vapor output, etc. Sweat may be assessed by measuring body temperature, ambient temperature, and ambient humidity, or in the case of a ventilated patient, the temperature and humidity of the inspired air may be measured. Alternatively or additionally, a skin sweat sensor may be used.

[0288] In addition to directly controlling medical devices, the loop controller 2928 can also sound alarms, including audible alarms, email alarms, text alarms, pager alarms, etc. The loop controller 2928 can also provide outputs to other systems for system integration, such as outputting information to an electronic health record (EHR) or other data archiving system or other systems. The loop controller 2928 can also receive input from various EHR, EMR or other systems.

[0289] As a result of the data collected and / or analyzed by the sensing Foley catheter system, a medical treatment can be administered to the patient. This treatment can be a medication that is automatically administered by a circuit controller, or it can be manually administered by traditional medication methods (i.e., oral, injection, etc.).

[0290] Further medical diagnostics may also be performed based on the results of sensing the Foley catheter system.

[0291] proportion

[0292] Urine specific gravity can be measured using pressure measurement and ultrasound measurement using a transduced Foley catheter. Fig.34 Graphs illustrating how ultrasonic measurements of volume and pressure measurements diverge with liquid density are shown. The liquid being measured is a synthetic urine concentrate having a specific gravity of approximately 1.100.

[0293] For a liquid with a specific gravity of 1.000, both measurement techniques are calibrated to provide the same volume measurement. However, they begin to diverge as density increases. In the case of pressure, an increase in density results in an increased volume reading because V = A*h and P = ρ*g*h, or V = A*ρ*g / P. In the case of ultrasound, an increase in density results in a decreased volume reading because V = A*h, v = h*2 / t, and v = (E / ρ)^(1 / 2), so V = A*(E / ρ)^(1 / 2)*t / 2.

[0294] V: Volume

[0295] A: Cross-sectional area

[0296] h: height of the liquid

[0297] P: Pressure

[0298] ρ: liquid density

[0299] g: gravity

[0300] v: speed of sound

[0301] t: time for sound to reflect

[0302] E: Bulk modulus of elasticity of the liquid

[0303] More simply stated, as the liquid increases in density, the pressure increases and skews the measurement high. At the same time, sound travels faster and skews the ultrasound measurement low. By measuring how much they are diffused, the density of the liquid can be determined. This assumes that the temperature has not changed, however, the temperature can also be monitored to correct for temperature variability. Volume measurements via ultrasound and pressure can be performed with a sensing Foley catheter, as can temperature measurements. In this way, a sensing Foley catheter in conjunction with a controller can determine the specific gravity of urine.

[0304] Reduce condensation

[0305] Balloon catheters, especially those designed to reside in the human or animal body for relatively long periods of time, may leak over time. For example, a balloon inflated with air or other gas may leak air out of the balloon over time. Alternatively, a balloon filled with liquid may leak liquid out over time. The opposite is also true. A balloon filled with gas or air residing in a fluid (such as urine, blood, etc.) may experience leakage of fluid into the balloon over time. This is particularly true where the balloon is inflated at a relatively low pressure.

[0306] A sensing Foley catheter is an example of a balloon that is designed to be inflated for a relatively long period of time and at a relatively low pressure. In this example where the balloon is designed to measure pressure, the balloon can be inflated at a relatively low pressure and, as a result, can be made of a relatively soft and thin material. Due to the low inflation pressure and the soft, thin balloon material, it is possible that liquid may leak into the balloon over time. Liquid in the pressure measuring balloon may adversely affect the very sensitive pressure measurement, particularly if the liquid migrates into the catheter lumen and pressure measurements are made through that catheter lumen.

[0307] One embodiment to solve this problem is to place a very small pore filter or hydrophobic filter between the pressure measuring balloon and the pressure measuring lumen of the catheter. This allows the balloon to be inflated and continuously filled to maintain its pressure, and the pressure measurement to be made through the catheter lumen. Air or gas can pass through the filter, but fluid cannot.

[0308] Another embodiment includes manufacturing the bladder from a material with low moisture permeability.

[0309] Another embodiment includes renewing the gas within the bladder by alternately applying vacuum and pressure to the bladder through either one or more than one chamber.

[0310] Another embodiment includes circulating the gas within the balloon by having more than one lumen into the balloon. One lumen can be used to introduce gas into the balloon, while another lumen can be used to extract gas from the balloon.

[0311] Another embodiment includes using a desiccant in the bladder, the bladder cavity, the gas supply to the bladder, or any combination of these.

[0312] Fig.35The distal end of a Foley-type balloon catheter that may benefit from condensation reduction is shown. In this example, the balloon catheter is designed to be placed in a patient's bladder to help drain urine from the bladder. The catheter has a retaining balloon 3506 that anchors the catheter within the bladder. The catheter shaft 3502 contains the lumen of the catheter. Opening 3504 allows urine to drain from the bladder through the catheter and out of the proximal end of the catheter (not shown). Opening 3508 is used to inflate and deflate the retaining balloon. A pressure sensing balloon 3510 is inflated and deflated through opening 3512. The pressure sensing balloon 3510 transmits a pressure signal from within the bladder through a pressure cavity within the catheter shaft and to a pressure transducer near the proximal end of the catheter.

[0313] In some cases, over time, fluid may leak into the pressure bladder 3510. Additionally, fluid may migrate from within the pressure bladder 3510 through the opening 3512 and into the catheter shaft 3502. Fluid within the pressure chamber may adversely affect the pressure reading from the pressure bladder. As a result, it is desirable to prevent fluid from migrating from within the pressure bladder through the opening 3512 (or, if possible, reduce the amount of fluid that enters the pressure bladder).

[0314] Fig.36 An embodiment of a filter in a capsule is shown. A filter 3602 resides between the interior of the capsule 3510 and the pressure chamber inside the catheter at the opening 3512. The filter 3602 is preferably made of a material that allows gas to pass through (but does not allow fluid to pass through). For example, the filter can be made of a hydrophobic membrane (such as Versapor, PTFE, ePTFE). The filter can be made of a polymer (such as nylon or any other suitable material). The pore size can be about 3 microns, or can be about 5 microns, or can range from about 0.2 microns to about 5 microns, or can range from about 5 microns to about 10 microns. The thickness of the filter can range from about 6 mils to about 12 mils. Alternatively, the thickness of the filter can range from about 1 mil to about 6 mils. The pore size is related to the capsule sensitivity. For example, a filter with a 5 micron pore size may be suitable for a capsule that is inflated to about 5 mmHg to about 20 mmHg, with the ability to sense a pressure difference as low as a 0.01 mmHg resolution range. If the pressure measured by the pressure capsule is not too sensitive, a smaller pore filter can be used. If the pressure measured by the pressure capsule needs to be more sensitive, larger pore filters can be used.

[0315] Fig.36A filter is shown in the form of a tube that surrounds the catheter shaft at opening 3512, completely covering the opening. The filter can be adhered to the catheter shaft at its ends using any suitable adhesive or other means (such as heat shrink). The seal between the filter and the catheter is ideally airtight so that gas entering and leaving the balloon 3510 through opening 3512 must pass through the filter 3602.

[0316] Fig.37 is another embodiment of the present invention that includes a smaller catheter shaft, wherein the filter is connected inside the balloon. The catheter shaft 3704 inside the balloon has a smaller diameter than the catheter shaft 3706 that is not below the balloon. This prevents the increased volume of the filter 3702 from increasing the diameter of the balloon after deflation.

[0317] Fig.38 shows the case where the bladder is deflated Fig.37 embodiment is shown, and it can be seen that the reduced diameter of the catheter shaft beneath the balloon region prevents significant expansion in the balloon catheter.

[0318] Fig.39 Another embodiment of a filter under the balloon is shown. In this embodiment, the filter 3902 does not completely surround the shaft of the catheter, but instead is a one-piece flat or curved filter adhered to the catheter shaft by adhesive or other suitable means. The adhesive preferably seals the filter completely around the edges of the filter without encroaching on the balloon inflation / deflation / pressure measurement opening 3512.

[0319] Fig.40 Another embodiment of a filter 4002 is shown in which the filter is shorter in length.

[0320] Fig.41 Another embodiment of a balloon catheter with a filter is shown. In this embodiment, the balloon catheter has two chambers that are in communication with the balloon fluid. Filter 4102 covers opening 4104, while opening 4106 is uncovered. In this embodiment, openings 4104 and 4106 can each enter a separate chamber or the same chamber of the catheter. In the embodiment where they enter separate chambers, balloon inflation, deflation, and pressure measurement can be performed through either chamber. For example, pressure measurement can be performed through a chamber that is in communication with the opening 4106 fluid until the accumulation of liquid in the chamber adversely affects the pressure measurement. At this point, the pressure transducer can be switched to a chamber that is in communication with the opening 4104 fluid so that pressure measurement can be performed through a chamber without liquid.

[0321] Alternatively, pressure measurements may be taken through the cavity in fluid communication with opening 4106 until liquid accumulation in the cavity adversely affects the pressure measurements. At this point, gas may be introduced into the cavity in fluid communication with opening 4106 to purge fluid from the cavity. Simultaneously, gas may be withdrawn from the capsule through the cavity in communication with opening 4104. In this manner, liquid may be purged from the cavity in communication with opening 4106 and pressure measurements may be restored through the cavity. This line purge process may be programmed to occur on a periodic basis.

[0322] Fig.41 Two balloon openings 4104 and 4106 are shown on different sides of the catheter, with the filter 4102 covering only one of the openings. Alternatively, Fig.42 Shown with Fig.41 The embodiment is similar to the embodiment of , except that the two openings 4204 and 4206 can be arranged side by side, where the filter 4202 only covers one of the openings.

[0323] Fig.43 An embodiment of the invention is shown in which a filter 4302 covers a larger opening 4304. A larger opening may be desirable to obtain more accurate pressure measurements from the balloon. Additionally, a larger opening is possible with the addition of filter 4302 due to the additional integrity that the filter (and possibly its bonding means) provides to the area of ​​the catheter around opening 4304.

[0324] Fig.44 An embodiment of the invention is shown in which a filter 4402 is connected to the catheter shaft via a heat shrink tubing segment 4404. This allows for an airtight seal between the filter and the catheter while ensuring that the catheter opening 4406 remains open.

[0325] Fig.45 Shown with Fig.44 4502 is connected to the catheter shaft by a heat shrink tubing segment 4504. This allows an airtight seal between the filter and the catheter while ensuring that the catheter opening remains open.

[0326] Fig.46 An embodiment of the invention is shown in which a filter 4602 is connected to the interior of the catheter at the opening of the catheter.

[0327] Fig.47An embodiment of the present invention is shown in which the balloon has two entry cavities 4702 and 4704. In this embodiment, the balloon catheter has two cavities in fluid communication with the balloon. In this embodiment, openings 4702 and 4704 can each enter a separate cavity or the same cavity of the catheter. In the embodiment where they enter a separate cavity, balloon inflation, deflation, and pressure measurement can be performed through either cavity. For example, pressure measurement can be performed through a cavity in fluid communication with opening 4702 until liquid accumulation in the cavity adversely affects pressure measurement, or until a set time period. At this point, gas can be introduced into the cavity in fluid communication with opening 4702 to clear fluid from the cavity. At the same time, gas can be extracted from the balloon through the cavity in communication with opening 4704. The opposite operation can also be performed-fluid can be introduced into the cavity in fluid communication with opening 4704 and removed from the cavity in fluid communication with opening 4702. In this way, liquid can be cleared from the cavity in communication with opening 4702, and pressure measurement can be restored through the cavity. The pipeline clearing process can be programmed to occur on a periodic basis. Openings 4702 and 4704 are shown here as being opposite each other, but the openings may be staggered.

[0328] Fig.48 and Fig.49 Two different pressure bladder designs are shown, however any suitable design and / or shape may be used. Depending on the material of the bladder, the bladder may be manufactured in different ways. Some materials are more suitable for blow molding, while some materials are more suitable for dip molding. Other manufacturing techniques may also be used, such as resistance heat sealing. Fig.48 An example of a blow molded bladder is shown. Fig.49 An example of a dip molded bladder is shown.

[0329] Some examples of materials from which the bladder may be fabricated include urethane, polyurethane, polyethylene, nylon, polyvinylidene fluoride, or any other suitable polymer or other material or any combination of materials.

[0330] A bladder coating may also be used to reduce the fluid permeability of the bladder. An example of such a coating is a poly(p-xylylene) polymer or parylene.

[0331] In some embodiments, it is desirable to prevent any moisture from entering the pressure bladder. In these embodiments, water or fluid impermeable materials can be used for the bladder. Some of the materials mentioned here are suitable. In addition, biaxially oriented polyethylene terephthalate (BoPET), often known by the brand name Mylar, can be used. Metallized polymers or any other suitable material can also be used.

[0332] In some embodiments, a sensing Foley-type catheter is configured to report the presence of water droplets or other obstructions in an air-filled cavity (such as a pressure cavity), and then process or decompose the water droplets. In particular, in low temperature environments, moisture in the air cavity may condense and form obstructive water droplets. Due to the surface tension of water, water droplets in the air-filled cavity (or bubbles in the water-filled cavity) may interfere with or complicate the pressure signal. Therefore, in some embodiments of the disclosed technology, the pressure transmission cavity may include hydrophilic features (such as a coating on the wall of the cavity itself, or hydrophilic fibers extending along the length of the cavity) to wick moisture away from the cavity so as to maintain a continuous, uninterrupted air channel. In some embodiments, a hygroscopic component (e.g., silica gel) may be used in line with the air infusion line or in the air infusion cavity itself to capture water or moisture. In some embodiments, a hygroscopic component may be included in the catheter so that the air infusion circuit does not need to be repaired to replace the material.

[0333] In some embodiments, dry air or gas may be used in the pressure chamber and pressure bladder to prevent moisture accumulation.

[0334] In some embodiments, a hydrophobic or hydrophilic coating may be used in the pressure chamber and / or the pressure bladder.

[0335] Gas content

[0336] Another embodiment includes using a hydrophobic filter or membrane as an interface with urine in the bladder or the mucosal lining of the urethra to measure the relative oxygen or other gas content of the urine or tissue.

[0337] In some embodiments of the sensing Foley catheter, it is desirable to measure the gas content of tissue and / or urine or the change in gas content over time. Possible gases of interest include oxygen, carbon dioxide, nitrogen, gases associated with anesthesia, or other gases. In some embodiments, the membrane is permeable to gases but not to liquids, for example, a hydrophobic membrane or other suitable membrane may be used. The pore size of the hydrophobic membrane may be about 5 microns. Alternatively, the pore size of the hydrophobic membrane may be about 3 microns to about 7 microns.

[0338] Fig.50 A sensing Foley catheter with a gas permeable membrane is shown. A retaining balloon 5002 is in fluid communication with an inflation / deflation port 5010. Urine flows through the catheter through an opening 5004 and out of a port 5012 that is in fluid communication with the opening 5004. A pressure sensing balloon 5006 is in fluid communication with a cavity 5014. A gas permeable membrane 5008 covers an opening at the distal end of the catheter that is in fluid communication with a cavity 5016.

[0339] Fig.51 A sensing Foley catheter having an oxygen permeable membrane similar to Fig.50 Oxygen permeable membrane is shown, except that membrane 5108 is located between pressure sensing bladder 5106 and retaining bladder 5102. Opening 5104 for urine can be placed anywhere away from retaining bladder 5102.

[0340] Fig.52 An embodiment of a sensing Foley catheter is shown in which the membrane 5204 is incorporated into the gas sensing balloon 5202. In this figure, the gas sensing balloon 5202 is remote from the pressure sensing balloon 5206, but in Fig.53 Another embodiment is shown in FIG. 52 where this is not the case. The gas sensing capsule 5202 may be made of silicone, polymer, or any other suitable material.

[0341] The membrane material can be similar to the hydrophobic membrane material described in other embodiments herein. The membrane is permeable to gas or to a specific gas or gases but not to liquids (such as urine). In this way, gas can pass through the membrane and into the catheter for measuring the gas content of tissue and / or urine and / or the change in gas content over time. The measured gas includes oxygen, nitrogen, carbon dioxide or other gases.

[0342] The catheter can be placed in the patient's body so that the membrane is either in the bladder or in the urethra. The membrane is shown here on a sensing Foley catheter with a pressure sensing balloon, but the gas permeable membrane can be placed on any indwelling catheter in the body, including catheters that reside in blood vessels or other body cavities. The membrane can be in direct or indirect contact with fluids, gases, or body tissues.

[0343] Fig.54 A controller is shown that controls the measurement of oxygen or other gases. The controller is typically external to the patient and connected to the catheter through a port, such as the port connected to cavity 5016. The controller may also control pressure sensing functions or other functions of the sensing Foley catheter, or it may be a separate controller.

[0344] Shown here is a representation of a gas measurement controller 5402 along with a conduit 5404 and a gas transfer membrane 5406. The gas measurement controller 5402 includes an air (or gas) inlet 5408, an air (or gas) exhaust 5410, a pump 5412, an oxygen or other type of sensor 5414, and a check valve 5416.

[0345] In this embodiment, a pump 5412 periodically pushes a small amount of air or other gas through the tube into the catheter. The air passes through the membrane "window" 5406, and the oxygen content of the air varies based on the oxygen content of the mucosal lining (if the gas transfer membrane is in the urethra) or urine (if the gas transfer membrane is in the bladder). Further downstream (back in the gas measurement controller box 5402), a fiber optic or other type of oxygen sensor is used to measure the oxygen percentage of the air. The pump can be operated for only short periods of time to allow the air to equilibrate with the tissues / fluids over system time.

[0346] Check valve 5416 helps limit mixing of air passing through the system with outside air or air from earlier measurement intervals.

[0347] The measured oxygen (or other gas) content can be very small. The measurement results can indicate either absolute gas levels or relative gas levels. For example, the gas measurement controller measurement results can show the relative oxygen content in the patient's body over time to indicate changes in the patient's state.

[0348] Fig.55 A schematic diagram is shown of how a gas measurement controller interacts with a catheter to measure the gas content of urine or patient tissue. Catheter 5502 includes a urine drainage lumen 5504 in fluid communication with a gas transfer membrane 5510 and gas measurement lumens 5506 and 5508. Lumen 5506 contains air or other gas that enters the catheter, and lumen 5508 contains air or other gas that leaves the catheter after the carrier gas passes through the gas transfer membrane. The oxygen (or other gas) level in the exiting gas is measured to determine the oxygen level or oxygen level change in the patient's urine and / or tissue. The incoming gas measurement lumen 5506 can be open to the atmosphere or other source, or it can be a closed system so that the gas within lumens 5506 and 5508 circulates continuously so that changes in gas content can be easily determined over time. In other words, Fig.54 The air (or gas) inlet 5408 and the air (or gas) exhaust port 5410 in the device may be fluidly connected to each other.

[0349] With the incoming gas measurement cavity 5506 open to atmosphere, the pump can be run intermittently, allowing the gas in the gas measurement cavity more time to equilibrate across the membrane surface. This results in a higher intermittent concentration of the gas being measured, and therefore a more sensitive measurement.

[0350] The pump may be run continuously or intermittently regardless of whether the system is closed or open, but more sensitive measurements may result if the pump is run intermittently in open system mode. In closed system mode, trends may be more apparent as the gas being measured within the system equilibrates with the gas level of the urine, fluid, or tissue being measured.

[0351] In this embodiment, the urine chamber and the gas measurement chamber are separated. However, the gas transfer membrane can also be located between the urine chamber and the gas measurement chamber, such as Fig.56 As shown, the gas transfer membrane 5602 is in fluid communication with the urine cavity.

[0352] Fig.57A and Fig.57B An embodiment of a gas measurement add-on component is shown. The gas measurement component 5702 can be inserted between the sensing Foley catheter 1000 or any Foley catheter and the urine drainage tube 1001 or any urine drainage tube. The gas measurement component 5702 includes a hydrophobic filter 5704 that can be made of materials disclosed elsewhere herein. A gas inlet chamber 5706 and a gas outlet chamber 5708 allow gas to pass through the filter 5704 in communication with urine gas within the drainage system. The air or gas near the filter 5704 equilibrates very quickly with the gas in the urine within the drainage system. Fig.57B The path of air flow across the filter 5704 is shown. The gas outlet chamber 5708 is in fluid communication with a controller (not shown here) that analyzes the gas in the chamber for one or more gases of interest. The gas inlet chamber 5706 can be open to the atmosphere, another gas, or can be in a closed loop with the gas outlet chamber 5708 in the controller. The controller can be the same controller that measures urine output as mentioned elsewhere herein, or can be a separate controller. The chambers 5706 and 5708 can be incorporated into the drainage tube 1001, or can be separate. The gas measurement component 5702 can be a separate component (as shown here), or can be incorporated into the ventilation barb 1016. The gas measurement component 5702 can be alternatively located anywhere in the system.

[0353] Detect / determine certain conditions

[0354] Fig.58A A table is shown listing combinations of parameters that allow for signatures or identifiers (combinations of parameters) for different indicators of AKI (prerenal, intrinsic, and obstructive). In addition, there may be signatures or identifiers for the timing of changes in the parameters, which may also determine the cause of the AKI (e.g., it is plausible that some parameters change faster for intrinsic AKI caused by glomerulonephritis than for intrinsic AKI caused by acute tubular necrosis). This multi-parameter approach may also facilitate the selection of effective therapies to treat AKI, as different causes of AKI have different effective therapies (e.g., recombinant alkaline phosphatase is effective in treating intrinsic (septic) AKI, but ineffective in treating non-septic AKI).

[0355] Fig.58BA table is shown listing combinations of parameters that allow for the marking or signatures (combinations of parameters) of different indicators of sepsis, AKI, and acute respiratory distress syndrome (ARDS). These signatures relate to increases, decreases, or increases and decreases in various patient parameters, including urine output, heart rate, respiratory rate, temperature, stroke volume, cardiac output, and abdominal perfusion pressure. Abdominal perfusion pressure is mean arterial pressure (MAP) minus intra-abdominal pressure (IAP). Mean arterial pressure is equal to diastolic pressure (DP) plus 1 / 3 of pulse pressure (PP). (Pulse pressure is equal to systolic pressure minus diastolic pressure.) In short, MAP = DP + 1 / 3 PP.

[0356] Other patient parameters may also be used. One, some, or all of the relevant parameters may be used by the controller to convey a diagnosis and / or risk to a user or another device. The patient parameters captured by the sensing Foley catheter system may be used independently or in conjunction with parameters obtained elsewhere, such as an EKG, a blood pressure measurement device, or information from an EMR.

[0357] The sensing Foley catheter system provides real-time, automatic, accurate physiological parameter monitoring for early detection of various medical conditions. By using real-time multivariate (point value) and time series (trend) analysis of these high-frequency data streams to inform our machine learning-inspired models, highly sensitive physiological signatures of early sepsis onset (or other medical condition determination) can be developed. This will improve clinical outcomes by enabling early diagnosis and intervention. Machine learning via artificial neural networks can be used to strengthen relevant parameters, weaken less relevant parameters, and establish or destroy connections to continuously improve data-related signatures related to physiological changes that occur before and / or during the onset of certain medical conditions. This will enable the controller to use algorithms to distinguish medical conditions from each other and from normal and other pathologies.

[0358] Some embodiments of the present invention can measure urine output immediately after giving the patient a diuretic. This type of test can be a strong indicator of whether a patient with AKI will progress to a more serious stage and / or death. If the patient's urine output increases after the administration of a diuretic, this indicates that the patient is unlikely to progress to a more serious stage of AKI. If the patient's urine output does not increase significantly after the administration of a diuretic, this indicates that the patient is more likely to progress to a more serious stage of AKI. The present invention can quickly and accurately measure urine output in real time. Therefore, compared with traditional urine measurement techniques, the reaction to diuretics can be detected more quickly (minutes instead of hours).

[0359] The test can be automated with a controller that provides a controlled dose of a diuretic and then monitors urine output over minutes or hours, preferably only minutes. The diuretic administered can be furosemide or any other suitable loop diuretic or other diuretic. A diuretic can be administered and data collected as disclosed in "Development and standardisation of afurosemide stress test to predict the severity of acute kidney injury" by Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Tumlin JA, Shaw AD, Trevino S, Kimmel PL, Seneff MG, which is incorporated herein by reference (Crit Care. 2013 Sep 20; 17(5): R207).

[0360] In addition to detecting AKI, the present invention is also capable of detecting urinary tract infection (UTI) as indicated by decreased oxygen tension, carbon dioxide levels, increased specific gravity, and relatively stable urine output and conductivity. Detection of UTI can be achieved in the absence of AKI and possibly in the presence of AKI by combining urine markers for UTI. The UTI marker can alert the clinician to the presence of a UTI.

[0361] In addition to using the parameters described to detect AKI and UTI, these parameters can also be used in conjunction with intra-abdominal pressure (IAP), respiratory rate (RR), heart rate (HR), cardiac output (CO), relative stroke volume (RSV), temperature (Temp), pulse pressure (PP), urine conductivity (UC), urine output (UO), and / or stroke volume (SV) readings, which have been used to detect conditions such as intra-abdominal hypertension (IAH), abdominal compartment syndrome (ACS), and sepsis. Adding IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, and / or SV measurements to the algorithms described herein can increase the sensitivity and specificity of detecting AKI or UTI. On the other hand, adding the measurements obtained by the present invention to the IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, and / or SV measurement algorithms can increase the sensitivity and specificity of detecting IAH, ACS, or sepsis. Other clinical applications include the treatment of trauma and burns.

[0362] In addition to absolute measurements of IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, gas concentrations, and / or SV, trend data for these parameters can also be used to detect IAH, ACS, sepsis, or other conditions. For example, the slope of the values ​​of these parameters over time and / or the variability of the values ​​of these parameters over time can also be used. Another example of using data trends is the use of pulse pressure waveform analysis and pulse wave velocity (or pulse transit time). Pulse transit time can be determined by capturing cardiac signals (such as EKG) from a wire on a sensing Foley catheter and / or elsewhere and determining the time it takes for the pulse wave pressure signal to propagate to the bladder. Multiple parameters and / or parameter trends can be used to determine the presence of IAH, ACS, sepsis, or other conditions.

[0363] Some examples of using trend data include:

[0364] - Decreased UO in a background of stable vital organs (otherwise) may indicate acute kidney injury. If stroke volume is reduced, then the kidneys may be ischemic. If urine volume surges in a background of stable vital organs, this may indicate toxic acute kidney injury.

[0365] -Increased respiratory rate together with decreased stroke volume may indicate pulmonary embolism, hemorrhage, or other volume deficiencies.

[0366] An increased respiratory rate in the context of stable vital organs may indicate impending airway obstruction.

[0367] - In the context of stability of other parameters, a decreased respiratory rate can indicate an overdose of anesthetic. This is a big problem for the patient's controlled analgesia.

[0368] - Increased intra-abdominal pressure (IAP) and increased urine output in a background of stable stroke volume can be indicators of impending fluid overload.

[0369] - Increased IAP with decreased UO and decreased cardiac output can be an indicator of cardiopulmonary insufficiency. This can be due to fluid overload, sepsis, etc.

[0370] The present invention can be used in various hospital environments (e.g., emergency rooms, operating rooms, intensive care units, wards). At any time, the device can be used to monitor the progression of AKI, and whether it is improving or declining. Its algorithm works to alert clinicians to the latest developing cases of AKI or changes in the state of AKI. The device can be placed before damage to the kidney occurs (e.g., patients undergoing cardiac surgery, to detect whether damage to the kidney begins during surgery) in order to detect the onset of AKI. It can be placed when damage to the kidney already exists in order to detect the extent of the damage at that time. The device can also be used to monitor the response to therapy / therapeutic interventions (e.g., renal replacement therapy, fluid resuscitation).

[0371] Alternative Embodiments

[0372] Embodiments of the technology can also report patient movement in the detection or diagnosis of epilepsy. In this embodiment, pressure changes can trigger EEG or recording equipment to allow for intensive monitoring periods during suspected epileptic seizures. Additionally or alternatively, pressure sensors, acoustic sensors, or other sensors can be used to detect intestinal activity, including peristalsis, patient movement, epileptic seizure activity, patient tremors, frequency of coughing, severity of coughing, sleep duration, sleep quality, voice detection, patient compliance (movement or its lack thereof), and can warn healthcare providers that the patient has not been moved and must be turned over or rolled over. This motion-related information can also be relayed to cryogenic equipment, drug delivery equipment, or other equipment to control or alleviate epileptic seizure activity, tremors, and / or coughing.

[0373] In some embodiments, a sensing Foley-type catheter is configured to report the presence of water droplets or other obstructions in an air-filled cavity (such as a pressure cavity), and then process or decompose the water droplets. In particular, in low temperature environments, moisture in the air cavity may condense and form obstructive water droplets. Due to the surface tension of water, water droplets in the air-filled cavity (or bubbles in the water-filled cavity) may interfere with or complicate the pressure signal. Therefore, in some embodiments of the disclosed technology, the pressure transmission cavity may include hydrophilic features (such as a coating on the wall of the cavity itself, or hydrophilic fibers extending along the length of the cavity) to wick moisture away from the cavity so as to maintain a continuous, uninterrupted air passage. In some embodiments, a hygroscopic component (e.g., silica gel) may be used in line with the air infusion line or in the air infusion cavity itself to capture water or moisture. In some embodiments, a hygroscopic component may be included in the catheter so that the air infusion circuit does not need to be repaired to replace the material.

[0374] In some embodiments of the disclosed technology, air may also be intermittently (and automatically) infused and extracted into the pressure sensing balloon so that the balloon is in a constant state of being optimally inflated, as described in more detail above. In the case of wicking fibers or hydrophilic coatings in the lumen, air extraction may also help remove and capture any water from the air line. In the example of a liquid-filled lumen, hydrophilic fibers or hydrophilic coatings on the interior of the pressure lumen would provide similar benefits in allowing the lumen to handle bubbles. In this example, bubbles may distort the signal, but the air-water interface surface tension is weakened by the hydrophilic coating in the lumen of the catheter.

[0375] In addition, customized extrusion and cavity shape can also be used to prevent obstruction in the case of a cavity filled with liquid and / or air. In some embodiments of the technology, for example, a Foley-type catheter can have a cavity that is star-shaped in cross-sectional profile. This cavity is usually free from the obstruction of water droplets because the water droplets tend to adhere to themselves and push away from the hydrophobic wall. This behavior tends to not allow the filling of the cross-sectional space and allows the air channel to remain open around the water droplets and communicate with the sensor. The same logic applies to bubbles in water in a hydrophilic star-shaped water cavity. In this example, the hydrophilic liquid will adhere to the wall and allow a continuous water column that excludes bubbles to the center of the cavity. The same applies to hydrophobic liquids in hydrophobic cavities. In some embodiments, the catheter can include an air channel and a sensor that is incorporated into the catheter itself or is capable of transmitting pressure back to the fluid cavity of the sensor.

[0376] The drainage tube may be a multi-lumen tube to accommodate the urine drainage line, the pressure lumen, and the wires of the thermocouple, and connected to the barb on one end and to the controller on the other end.

[0377] Foley catheters may be extruded with BaSO4 or have radiopaque markers attached to provide fluoroscopic visualization.

[0378] The thermistor at the tip of the catheter can be secured in place using a variety of extrusion profiles and assembly techniques.

[0379] In some embodiments, the sensing Foley catheter may include a blood pressure sensing element, which may take any of several forms. In one embodiment, the blood pressure sensing element includes a pressure delivery bladder (either a separate dedicated bladder or a bladder in fluid communication with the device holding bladder or pressure sensing bladder) that can be optically analyzed when inflated to determine at which pressure the blood vessels within the bladder or urethra turn white and blood flow is stopped. This method provides a reading of the tissue perfusion pressure adjacent to the pressure delivery bladder, such a reading reflects both systemic blood pressure and vascular resistance. This embodiment of the perfusion pressure device can be used to provide early detection or monitoring of various acute or emergency medical conditions (such as sepsis, shock, hemorrhage), and is particularly advantageous in detecting these conditions at an early stage. In predicting sepsis, embodiments of the present invention may be able to receive white blood cell count information to better predict sepsis.

[0380] Other modalities may also be used to detect that tissue has become blanched or ischemic, with a common method aspect being the aspect of intermittent inflation within a cavity, body cavity, or body tissue to provide compression of the vasculature. Embodiments of the apparatus and associated methods may also be used to detect perfusion pressure in other areas of the body utilizing intermittently inflatable members and optical detection of blood flow or blood presence.

[0381] Tissue perfusion information can also be provided by sensors placed on the shaft of the catheter so that when the catheter is in place, the sensors contact the urethral wall. These sensing technologies may include microdialysis, pyruvate, lactate, pO 2 , pCO 2 , pH, perfusion index, near infrared spectroscopy, laser Doppler blood flow measurement, urethral capnography, and orthogonal polarization spectroscopy. Any of these tests can also be performed on the urine or the bladder wall itself to produce a measure of tissue perfusion.

[0382] Another embodiment of the sensing Foley catheter system includes an embodiment of a clearing mechanism that includes a device and / or port for positive air flow near the beginning of the drainage line. The positive air flow facilitates drainage by forcing urine to flow through the drainage line. The positive air flow device may include a one-way valve at the end of the urinary catheter that allows urine to flow only to the urine collection device and prevents air from entering the catheter.

[0383] In some embodiments, the urine removal mechanism includes a coating on the inside of the urine drainage tube to reduce surface tension and promote drainage. In one aspect, the coating is a hydrophobic polymer, including but not limited to PTFE or FEP.

[0384] In yet another embodiment, the clearing mechanism includes a tubular hydrophobic vent filter that can be inserted into the drainage chamber of the device so that air will be discharged over its entire length. It is also possible to merge segmental hydrophobic vents at set intervals to ensure that air is discharged from the tube when it passes through these areas. In this embodiment, the hydrophobic vent will be spaced at a minimum of 1-2 feet to prevent the vent from being immersed in urine. By providing redundancy, multiple vents / filters prevent the failure of any filter / vent due to its immersion. In an ideal configuration, the vent should be PTFE or ePTFE material, and should be fixed together with barbs at certain intervals and / or be perforated into the tube to allow easy manufacturability. In an alternative embodiment, the vent takes the form of a slit or spiral extending along the length of the drainage tube, thereby allowing air to escape the tube at any point. This prevents the drainage tube from being positionally related when preventing and / or eliminating air plugs.

[0385] In an alternative embodiment, air lock is prevented by means of an extendable drainage tube that prevents air pockets from forming in the high portion of the tube and prevents urine from collecting in the low portion. The extendable tube prevents this from occurring by keeping the tube as straight as possible between the catheter and the collecting bag. In one aspect, the extendable drainage tube is composed of a plurality of telescopic segments that can be extended or collapsed to match the distance from the patient to the collecting bag. In another aspect, the drainage tube is pleated to form pleats that can be extended or collapsed or deformed when necessary. In yet another aspect, the tube is coiled. In yet another aspect, the drainage tube is retractable by means of a spring coil that wraps the tube around a wheel to achieve the appropriate length.

[0386] Relative cardiac output and relative tidal volume can also be calculated based on the deflection of the pressure sensor and / or other dynamometers. If sampled at a sufficient frequency (e.g., 1 Hz or greater), respiratory excursion can be quantified in the form of the amplitude of the excursion relative to the time of catheter placement. Larger excursions are generally associated with heavier breathing, or with higher peritoneal pressures in the context of an upward drift in the baseline. Small peaks on the oscillating respiratory wave caused by the pulsating heart can also be tracked by using a faster sampling rate (e.g., 5 Hz or greater), and the amplitude of this wave can be used in the context of a relatively constant peritoneal pressure to determine relative cardiac output in the context of a known, stable peritoneal pressure, absolute stroke volume, and / or cardiac output.

[0387] Intra-abdominal pressure or bladder pressure as sensed by embodiments of the disclosed technology can also be used to detect the level of patient movement (e.g., can vary between essentially no movement to high levels of movement) and report the movement level to a healthcare provider. Short bursts of peaks and valleys in bladder pressure activity can be used as a proxy for body movement, because such a bladder pressure profile is a strong indicator that the patient is using their abdominal muscles to, for example, sit up or get out of bed. This embodiment can be of particular benefit to patients at risk of falling. For patients at risk of falling, a healthcare provider can be notified that the patient is sitting up and react accordingly. Alternatively, the device can be used to report patient inactivity and / or lack of patient movement.

[0388] The pulse oximetry element allows for determination of blood oxygen concentration or saturation and can be placed anywhere along the length of the urethra in the catheter. In some embodiments, one or more sensors are disposed within the tube of the device to ensure access to the urethral mucosa. Using this technology, a healthcare provider can decompress the bladder with a catheter and obtain pulse oximetry data in a repeatable and accurate manner. The power supply for pulse oximetry can be incorporated into the urine collection container or into the catheter itself. In some embodiments, the pulse oximeter is reusable and the catheter interface is disposable; in this arrangement, the pulse oximeter is reversibly connected to the disposable catheter and removed when oxygen measurement is no longer required. Embodiments of the sensing Foley catheter may include an optically transparent or sufficiently transparent channel for the oximetry signal, such as a fiber optic cable, a transparent window, and an interface for a reusable oximeter. This method and apparatus for urethral pulse oximetry can be used in conjunction with any other embodiment detailed herein, or can be a stand-alone device.

[0389] Antimicrobial coatings or materials impregnated with antimicrobial compounds may be used on the sensing Foley catheter to prevent infection. Examples of antimicrobial coatings / materials include silver, silver citrate, parylene, or any other suitable material.

[0390] Pulmonary blood volume variability can also be determined by the sensing Foley catheter system to help assess the presence or risk of heart failure. Reduced left ventricular function can lead to an increase in pulmonary blood volume (PBV) or a decrease in pulmonary blood volume variation. PBV variation is defined as the change in PBV over time during the cardiac cycle. PBV can be determined as the product of cardiac output and lung transit time. Cardiac output can be determined as the product of stroke volume and heart rate, where stroke volume is the area under the flow-time curve in one cardiac cycle. By focusing on the delay between the QRS complex in the EKG and the appearance of the signal in the bladder, the pulse transit time can be obtained. The EKG signal can be obtained from a separate EKG wire, a wire incorporated into the sensing Foley catheter, a wire incorporated into the catheter insertion kit, or elsewhere. The EKG wire may also be able to read the EKG signal from urine anywhere in the system. 2 wires can be used to more accurately determine the pulse transit time.

[0391] It has been found that stroke volume, ejection fraction, and PBV variation are reduced following myocardial infarction, with the greatest changes seen in PBV variability. Therefore, determining PBV variation and determining a decrease in PBV variation can be a strong indicator of heart failure or risk of heart failure.

[0392] The data collected by the sensing Foley catheter system can be stored in a database and analyzed for trends or other purposes. The data may include clinical and / or device data. For example, data can be collected from several patients and anonymously aggregated for better treatment, monitoring, or prediction of future patient behavior. For example, data related to heart rate, respiratory rate, temperature, infection, etc. collected over time can be aggregated and analyzed by a controller to find trends, such as the relationship between various parameters and results. For example, certain trends in temperature alone or in combination with other parameters may be predictors of infection, the onset of sepsis, ARDS, and / or AKI. Figures 58A-58B Some known examples are shown, but other and currently unknown trends may emerge from the aggregated patient data.

[0393] The data collected by the sensing Foley catheter system can be integrated with an electronic health record (EHR) or electronic medical record (EMR) and / or other systems. The data collected by the sensing Foley catheter system controller can be directly or indirectly interfaced with the EMR / EHR system. Data from the EMR / EHR (such as patient demographic or medical history data) can also be integrated with the sensing Foley catheter system.

[0394] Examples of Data Processing Systems

[0395] Fig.60is a block diagram of a data processing system that can be used with any embodiment of the present invention. For example, system 6000 can be used as part of a controller as shown in several embodiments herein. Note that although Fig.60 Various components of a computer system are shown, but it is not intended to represent any particular architecture or manner of interconnecting the components; as these details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablet computers, cell phones, and other data processing systems having fewer components or perhaps more components may also be used with the present invention.

[0396] like Fig.60 As shown, computer system 6000, as a form of data processing system, includes a bus or interconnect 6002 coupled to one or more microprocessors 6003 and ROM 6007, volatile RAM 6005, and non-volatile memory 6006. Microprocessor 6003 is coupled to cache memory 6004. Bus 6002 interconnects these various components together and also interconnects these components 6003, 6007, 6005, and 6006 to a display controller and display device 6008 and to input / output (I / O) devices 6010, which may be a mouse, keyboard, modem, network interface, printer, and other devices known in the art.

[0397] Typically, input / output devices 6010 are coupled to the system via input / output controllers 6009. Volatile RAM 6005 is typically implemented as dynamic RAM (DRAM), which continuously requires power to refresh or maintain data in the memory. Non-volatile memory 6006 is typically a magnetic hard drive, magnetic optical drive, optical drive, or DVD RAM or other types of memory systems that retain data even after power is removed from the system. Typically, non-volatile memory will also be random access memory, but this is not required.

[0398] Although Fig.60The non-volatile memory is shown as a local device that is directly coupled to the rest of the components in the data processing system, but the present invention can utilize non-volatile memory that is remote from the system; such as, a network storage device coupled to the data processing system through a network interface (such as a modem or Ethernet interface). Bus 6002 may include one or more buses connected to each other through various bridges, controllers and / or adapters, as is known in the art. In one embodiment, I / O controller 6009 includes a USB adapter for controlling USB (Universal Serial Bus) peripheral devices. Alternatively, I / O controller 6009 may include an IEEE-1394 adapter for controlling FireWire devices, which is also known as a FireWire adapter.

[0399] Some portions of the foregoing detailed descriptions are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. These operations are those requiring physical manipulations of physical quantities.

[0400] It should be remembered, however, that all of these and similar terms should be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise, as will be apparent from the following discussion, it should be appreciated that throughout this specification, discussions utilizing terms such as those set forth in the following claims refer to the actions and / or processes of a computer or computing system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and / or memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

[0401] The techniques shown in the figures may be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices use computer-readable media (such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read-only memory; flash memory devices; phase change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustic or other forms of propagated signals such as carrier waves, infrared signals, digital signals)) to store code and data and transmit code and data (internally and / or over a network with other electronic devices).

[0402] The processes or methods depicted in the preceding figures may be performed by processing logic including hardware (e.g., circuits, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer-readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.

[0403] Unless otherwise specified, all technical terms used herein have the same meaning as those generally understood by those of ordinary skill in the medical field. Specific methods, equipment and materials are described in this application, but any methods and materials similar or equivalent to the methods and materials described herein may be used in the practice of the present invention. Although the embodiments of the present invention are described in considerable detail and as examples, such examples are only for the purpose of clarity of understanding and are not defined as limiting. Various terms are used in this description to convey the understanding of the present invention; it will be understood that the meaning of these various terms extends to their common language or grammatical variations. In addition, although some theoretical considerations may be proposed to facilitate the understanding of the provision of technology, the appended claims of the present invention are not constrained by such theories. Any one or more features of any embodiment of the present invention may be combined with any one or more features of any other embodiment of the present invention without departing from the scope of the present disclosure. Further, it should be understood that the present invention is not limited to the embodiments set forth for illustration, but is limited only by the fair reading of the claims attached to this patent application (including the full range of equivalence to which each element is entitled).

[0404] Some embodiments of the sensing Foley catheter system include the use of UV light or light of an appropriate wavelength to disinfect the collection chamber itself or other components of the system. The UV light source can direct the UV light through the wall of the collection chamber, or alternatively, the UV light source can be located inside the collection chamber. The UV light source can be used to disinfect the collection chamber when the collection chamber is empty, full, or partially full. The UV light source can be used to disinfect urine as it enters the collection chamber. The UV disinfection process can occur continuously or intermittently. The UV light source can be located anywhere in the sensing Foley catheter system. UV light or other wavelengths of light can be used within the bladder.

[0405] Spectroscopy-Spectrophotometry

[0406] Some embodiments of the sensing Foley catheter system include using wavelengths of light in the range of about 520 nm to about 650 nm to identify bacteria, red blood cells, and / or plasma / white blood cells. Fig.61 The area inside the ellipse.

[0407] Some embodiments of the sensing Foley catheter system include combining spectrophotometry to identify white blood cells and bacteria with identifying a decrease in PO2 and / or an increase in CO2 to identify infection.

[0408] Some embodiments of a sensing Foley catheter system include a controller that filters urine output data to compensate for increased urine output immediately following the administration of a diuretic. Urine output typically increases immediately following the administration of a diuretic. However, in certain circumstances, it may be beneficial to substantially ignore urine output data associated with the administration of a diuretic. A controller of a sensing Foley catheter system may automatically ignore urine output data associated with the administration of a diuretic by identifying the shape of a urine output curve associated with the administration of a diuretic and subtracting and / or ignoring data associated with this increase. Identification of the shape of the curve may be accomplished by slope, length of increase, amplitude of increase, shape, etc. Subtraction of diuretic-induced urine output data may be beneficial in determining or predicting the onset of AKI. See Fig.62 For example, where urine output rises above approximately 2000 ml / hour (peak), the controller may identify this as an instance where a diuretic has been administered.

[0409] The increased urine output caused by the use of diuretics can be distinguished from the increased urine output caused by the clamping or otherwise blocking of urine drainage tubes and / or Foley catheters. In the case where the drainage chamber is clamped, the urine output before the increase will be substantially zero or very low, for example, less than 5ml / hour. On the contrary, in the case of the diuretics used, the urine output immediately before the use of the diuretics may be very low, but will likely be higher than zero, for example, higher than about 5ml / hour. In addition, in the case where the drainage chamber is clamped, the increased urine output after the release of the drainage chamber will last for a relatively short period of time, for example, about 30 seconds to about 5 minutes. In contrast, in the case of the diuretics used, the increased urine output will last for a longer period of time, for example, about 30 minutes to about 2 hours. In addition, in the case where the drainage chamber is clamped, the urine output after the release of the drainage chamber will likely be less than about 1000ml. In contrast, with a diuretic administered, the urine output following administration of the diuretic will likely be greater than about 1000 ml. Any or all of these factors may be used by the controller to analyze the urine output volume over time to determine when a diuretic was administered and to subtract the increased urine output volume due to the diuretic from the urine output presented to the user.

[0410] In this way, the controller can automatically determine when a diuretic is administered. Alternatively, the user interface of the controller may include a button or other user input device (touch screen, voice control, etc.) that indicates when a diuretic is administered. The controller will then look for increased urine output and subtract the increased urine output due to the diuretic from the urine output data presented to the user.

[0411] Some embodiments of the sensing Foley catheter system include a controller determining abdominal perfusion pressure (APP). APP is defined as the difference between mean arterial pressure and intra-abdominal pressure (IAP). Mean arterial pressure can be determined in a conventional manner and combined with the controller's determination of IAP to determine APP. The controller can further automatically vary the infusion of fluids and / or pressors / vasopressors to increase or decrease blood pressure.

[0412] Prevent wetting of filter / vent.

[0413] Some embodiments of the sensing Foley catheter system include one or more vents and / or filters to prevent negative pressure from accumulating within the Foley catheter and causing suction injury to the bladder. The filter / vent can be located at the junction of the Foley catheter and the drain tube or elsewhere, such as within a collection container or even within the lumen of the drain tube or Foley catheter itself, as will be described below.

[0414] In some embodiments, the filter / vent is designed to repel fluid, i.e., fluid from a hydrophobic material. However, despite the use of a hydrophobic material, the filter / vent may still be susceptible to wetting by fluids, particularly urine. Some embodiments include a larger cavity or cavity area in which the filter / vent is located to reduce the surface tension of the fluid causing the fluid 6302 to fill the cavity. Fig.63A A smaller diameter cavity is shown, where Fig.63B A larger diameter cavity in the vent / filter area is shown. Note that when the vent / filter 6304 is facing upward or outward, the smaller cavity may still allow wetting of the filter / vent with the fluid 6302, where the larger cavity may reduce the likelihood of wetting of the filter / vent.

[0415] In embodiments where the filter / vent is located at or near the junction of the Foley catheter and the drainage tube, an area below or near the filter / vent can be taped to the patient's leg to stabilize the Foley catheter once it is in place. In this case, the larger lumen helps prevent wetting of the filter / vent, especially when the vent / filter is oriented away from the leg and therefore away from the patient. In some embodiments, the vent barbs can be designed so that when the barbs or barb area is taped to the patient's leg, the vent / filter faces outward. For example, the barbs can be curved or connected to a curved base, such as Fig.64 As shown, for better connection and orientation to the patient's leg 6402.

[0416] In some embodiments, the barb region may be elongated, for example between 6 and 12 inches, with the vent / filter placed further away from the patient to allow the vent / filter to be easily placed in a position and manner that prevents wetting.

[0417] In some embodiments, the vents / filters can be placed in multiple locations around the diameter of the drainage lumen, either within the barbs or elsewhere. Alternatively, the vents can surround all or a majority of the circumference of the lumen. In these embodiments, a reinforcing cuff or other structure can surround the vents to provide structural integrity to the lumen. The filters / vents can also be placed along the length of the drainage tube.

[0418] Fig.65 The embodiment shown in will also prevent wetting of the vent / filter. This embodiment includes a vent tube 6502 having an inner lumen connected to a drainage lumen 6504 near a barb area 6506 and vented to atmosphere or other air / gas / fluid via one or more filters / vents 6508 along the vent tube and / or near the other end. The filters / vents may be in a collection container, such as Fig.65 as shown, or may be elsewhere, for example separate from the collection container.

[0419] The vent lumen can be incorporated into the drainage lumen, either alongside or within the urine drainage lumen. The vent lumen can alternatively be separate from the drainage lumen and connected to the drainage lumen at the vent / drainage tube junction (e.g., near the barb region 6506).

[0420] Fig.66The illustrated embodiment shows a sensing Foley catheter system with a positive pressure vent tube 6602 having an inner lumen in fluid communication with a urine drainage lumen 6604 and a pump 6606. The positive pressure vent tube may include a filter 6612 anywhere along its length, in-line or otherwise. The positive pressure vent tube may include a vent at either end of the tube, anywhere along the tube, or may include multiple vents.

[0421] The pump draws negative pressure on the urine drainage chamber instead of pumping positive pressure into the atmosphere, and the positive pressure is pumped back to the urine drainage chamber through the positive pressure tube. Alternatively, different pumps can be used for negative pressure and positive pressure. In this way, accurate negative pressure or positive pressure can be controlled at the junction 6608 of the urine drainage chamber and the positive pressure ventilation tube. Preferably, the pressure in the junction 6608 is slightly negative or neutral to prevent the fluid from flowing back into the Foley catheter. For example, the pressure in the junction can be maintained at about 0mmHg. Alternatively, the pressure at the junction can be maintained at about-2mmHg. The optional regulator 6610 can control the negative pressure relative to the positive pressure by size, timing, etc. For example, the regulator (which is controlled by a controller) can achieve a slight delay so that negative pressure is first drawn on the urine drainage line, and then after a set time or when a specific negative pressure is reached, positive pressure is applied to the positive pressure tube, and finally applied to the positive pressure tube / drainage tube junction. This will prevent the net pressure at the positive pressure tube / drainage tube junction from being positive and will cause urine to flow into the bladder rather than out of it. An optional regulator can be in the form of a specifically sized vent (lower surface area or denser filter material for greater resistance, larger surface area or looser filter material for less resistance). The positive pressure vent tube can be connected to the urine drainage lumen through a valve (such as an umbrella valve with a set burst pressure).

[0422] Alternatively, the positive pressure tube can be pressurized by compressed sterile fluid / gas / air.

[0423] In addition, precise control of the negative pressure applied to the bladder can allow for duplication of normal filling and draining of the bladder. For example, a neutral or zero pressure can be maintained, or even a slightly positive pressure can be maintained at the base of the Foley for a period of time, allowing the bladder to fill normally. Then, either after a set period of time or after a certain pressure is reached (i.e., the pressure required to maintain neutral pressure at the base of the Foley catheter), the pressure is reduced, allowing the bladder to empty or drain. This process can be controlled by a controller that controls the pressure regulator to repeat the process to simulate normal filling and emptying of the bladder.

[0424] In some embodiments, a valve may be used at the base of the Foley catheter to better control the pressure in this area, including the pressure (negative or positive) applied on the bladder.

[0425] Note that the positive pressure tube embodiments can be used with any sensing Foley catheter system embodiments (including those with filter / vent configurations different from those shown herein). In addition, any anti-gas plug embodiments can be used with conventional (i.e., non-sensing) Foley catheters or other catheters or drains.

[0426] Figures 67-86 Shows Fig.66 An enlarged view of the barb region X of FIG. 1 is provided to show examples of different embodiments of this region.

[0427] exist Fig.67 In the illustrated embodiment, a valve 6702 (such as an umbrella valve with a set burst pressure) is shown between the lumen of the positive pressure vent tube 6602 and the urine drainage lumen 6604. The valve can be a one-way valve. The vent 6704 is shown between the positive pressure vent tube and the atmosphere. There may also be configurations in which only the vent or only the valve is present. The opening 6706 is in fluid communication with the urine drainage lumen 6604 and the chamber 6714 (the valve 6702 periodically cuts off the fluid communication with the chamber). The chamber 6714 is in fluid communication with the lumen of the positive pressure vent tube 6602. Periodically or continuously, positive pressure is applied through the positive pressure lumen 6602 and / or negative pressure is applied to the urine drainage lumen 6604. When the burst pressure of the valve 6702 is exceeded, a fluid (preferably a gas) flows through the valve 6702 and through the opening 6706 and through the lumen of the urine drainage lumen 6604. This is used both to clear air plugs or any blocked lines and to clear any fluid from chamber 6714, which reduces the likelihood of vent 6704 becoming wet. It can also be used to clear vent 6704 when vent 6704 is already wet. The bursting pressure of valve 6702 refers to the pressure difference between positive pressure chamber 6602 and urine drainage chamber 6604. If the pressure in the urine drainage chamber is below the pressure in the positive pressure chamber by the bursting pressure, the valve opens, allowing fluid to flow from the positive pressure chamber through the chamber, through opening 6706, and through the drainage chamber. For example, the bursting pressure can be less than about 1 mmHg. Alternatively, the bursting pressure can be less than about 2 mm Hg. Alternatively, the bursting pressure can be less than about 3 mm Hg. Alternatively, the bursting pressure can be less than about 4 mm Hg. Alternatively, the bursting pressure can be less than about 5 mm Hg. Alternatively, the bursting pressure can be less than about 10 mm Hg.

[0428] The pressure in the urine drainage cavity may be periodically or continuously about -5 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -7 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -10 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -15 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -20 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -25 mm Hg. Alternatively, the pressure in the urine drainage cavity may be periodically or continuously about -30 mm Hg.

[0429] The positive pressure in the positive pressure chamber may be approximately 5 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 7 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 10 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 15 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 20 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 25 mm Hg periodically or continuously. Alternatively, the positive pressure in the positive pressure chamber may be approximately 30 mm Hg periodically or continuously.

[0430] The vent may additionally or alternatively be present elsewhere along the positive pressure ventilation tube, such as near a pump, or as part of a pressure regulator. Fig.67 A second vent / valve assembly 6708 is shown on the barb in the figure, however, the second vent / valve assembly may or may not be present. An optional thermistor 6710 and an optional pressure chamber 6712 are also shown. The positive pressure vent tube may alternatively be exposed to atmospheric pressure. The valve or additional valves may be present anywhere in the system, including within the positive pressure tube 6602 or within the reservoir.

[0431] Fig.68 An embodiment of a barb region including a vent 6802, a valve 6804, and a small cross-sectional area 6806 is shown that is large enough to allow air / gas to flow freely from the vent to the urine drainage cavity, but small enough to prevent liquid from flowing to the vent. For example, the narrow portion 6806 can be less than about 1 mm in diameter. Alternatively, the narrow portion can be less than about 2 mm in diameter. Alternatively, the narrow portion can be less than about 3 mm in diameter. Alternatively, the narrow portion can be less than about 4 mm in diameter. The narrow portion can be about 1-5 mm in length. Alternatively, the narrow portion can be about 5 mm-30 mm in length. Fig.68The embodiment shown may or may not include a positive pressure tube - it is shown without a positive pressure tube (i.e., exposed to atmosphere). This embodiment may or may not include a valve. This and any embodiment may be incorporated into the barb, or may be a separate component that can be added to the barb (via a sampling or other port) or elsewhere in the system (e.g., along the drain, preferably the 1 / 3 of the drain closest to the patient).

[0432] Fig.69 An embodiment of the barb region including a vent 6902 and a long vent tube 6904 is shown, the vent tube 6904 allowing air / gas to flow freely from the vent to the urine drainage chamber, but being long enough to prevent liquid from flowing to the vent. For example, the vent tube portion 6904 can be about 1-10mm in diameter and can be about 1-10cm in length. For example, the vent tube portion 6904 can exceed about 2cm in length. Alternatively, the length of the vent tube portion 6904 can exceed about 4cm. Alternatively, the vent tube portion 6904 can exceed about 10cm in length. Fig.69 The embodiment shown may or may not include a positive pressure line - it is shown without a positive pressure line. The embodiment may or may not include a valve.

[0433] Fig.70 One embodiment is shown of a barbed region including a vent 7002 and a long curved vent tube 7004 that allows air / gas to flow freely from the vent to the urine drainage lumen, but is curved enough to prevent liquid from flowing to the vent. For example, the vent tube portion 7004 can be a coil. Fig.70 The embodiment shown may or may not include a positive pressure line - it is shown without a positive pressure line. The embodiment may or may not include a valve.

[0434] Fig.71 One embodiment is shown of a barb region including a vent 7102 and a compact curved vent tube 7104 that allows air / gas to flow freely from the vent to the urine drainage lumen, but is curved enough to prevent liquid from flowing to the vent. For example, the vent tube portion 7104 can be a tube with a baffle or mesh in the inner cavity. Fig.71 The embodiment shown may or may not include a positive pressure line - it is shown without a positive pressure line. The embodiment may or may not include a valve.

[0435] Fig.72An embodiment including a vent 7202 and a barb region of a vent tube 7204 is shown. In this embodiment, the vent tube is in fluid communication with the positive pressure tube 7206, and the vent 7202 is in line with the positive pressure chamber so that fluid under positive pressure passes through / through the vent and enters the drainage chamber via opening 7208. The vent tube 7204 is shown here as coiled to help prevent any backflow of urine into the vent tube, however, the vent tube 7204 can have any configuration, including a straight tube or a chamber built in the barb region. The vent 7202 is shown here near the junction of the vent tube 7204 and the positive pressure tube 7206, however, the vent can be anywhere along the positive pressure chamber, including near the pump / cassette, or near the opening 7208 of the drainage chamber. This embodiment may or may not include a valve.

[0436] Fig.73A and Fig.73B An embodiment of a barb region including a vent 7302 and a compact curved vent tube 7304 is shown, the vent tube 7304 allowing air / gas to flow freely from the vent to the urine drainage cavity, but being sufficiently curved to prevent liquid from flowing to the vent. In addition, the vent end of the vent tube 7304 can be configurable or bendable or deformable so that it can be directed upward after the barb region is fixed to the patient's leg. By directing the vent end of the vent tube upward, the chance of the vent being exposed to liquid is reduced. For example, the vent tube portion 7304 can be substantially a flat coil. Figures 73A-73B The embodiment shown may or may not include a positive pressure line - it is shown without a positive pressure line. This embodiment may or may not include valve 7306.

[0437] Fig.74 The embodiment of the barb area including multiple vents 7402 and optional valve 7404 is shown. Multiple vents reduce the chance that all vents are wetted by urine. Multiple vents can be in any suitable configuration including line, circle, etc. Multiple vents can be on one side of barb, or can partially or completely surround barb. For example, 2 vents can be included, or for example 3 vents can be included, or for example 4 vents can be included, or for example 5 vents can be included, or for example 6 vents can be included, or for example 7 vents can be included, or for example 8 vents can be included, or for example 9 vents can be included, or for example 10 vents can be included. Fig.74 The embodiment shown may or may not include a positive pressure line - it is shown without a positive pressure line. The embodiment may or may not include a valve.

[0438] Fig.75AAn embodiment of a barb region is shown that is independent of a vent, although it may still include one or more vents. In this embodiment, the positive pressure tube 7502 is in fluid communication with the urine drainage lumen through opening 7504. In addition, a valve (preferably a pressure sensitive valve) 7506 is between opening 7504 and the drainage catheter and is in fluid communication with a positive pressure source through opening 7510. Valve 7506 is located between opening 7504 and the drainage catheter. Fig.75A Depicted as an inflatable valve, such as a donut-shaped bladder (also in Fig.75B 7506 can be inflated by connecting to the same pressure source or a separate source to which positive pressure tube 7502 is connected. Valve 7506 can be in fluid communication with the lumen of positive pressure tube 7502, as shown here, or can be inflated by a separate positive pressure lumen.

[0439] In this embodiment, valve 7506 is closed when positive pressure is periodically applied to the drainage lumen through positive pressure tube 7502. Closure of the valve prevents air or positive pressure from reaching the bladder and allows positive pressurized fluid (gas or liquid) to purge the drainage lumen. When the positive pressure in the positive pressure tube decreases, the valve opens and urine is again allowed to drain from the bladder. A slight positive pressure can be maintained in the positive pressure tube to offset the negative pressure in the urine drainage line. If a higher pressure is needed to clear an air lock from the line, valve 7506 is closed for the duration of the higher pressure flush.

[0440] Fig.76 Shown with Fig.75A The embodiment shown in Figure 1 is similar to the embodiment shown in Figure 2, however in this embodiment, valve 7602 is a passive mechanical valve. Valve 7602 is normally in a flat or open position. When the positive pressure in the positive pressure tube is higher than any negative pressure in the drainage lumen, the valve automatically closes so that fluid / positive pressure is not delivered to the patient's Foley catheter / bladder.

[0441] Alternatively, a venturi tube may be used to control the negative and positive pressures seeping over the barb area, similar to an automobile carburetor.

[0442] Fig.77A and Fig.77B Another embodiment using a more active valve system is shown. This embodiment includes an aspiration chamber 7702, a compliant portion 7704, a patient-side valve 7706, a drain-side valve 7708, a drain lumen inlet 7710, and pressure lines 7712, 7714, 7716, 7718.

[0443] In the passive or open position, both the patient-side valve 7706 and the drain-side valve 7708 are open, i.e., the bladder / bladder is not inflated, allowing urine to flow freely from the drainage catheter 7722 through the barbed drainage lumen 7720 and through the drainage tube 7724. In the open position, the compliant portion 7704 is in a neutral position. When an occlusion event (such as an air lock) occurs or periodically to prevent occlusion, the drain-side valve 7708 is closed by applying pressure (such as a pressurized fluid (gas or liquid)) through the pressure line 7716. The compliant portion 7704 is inflated by applying negative pressure through the pressure line 7718. The pressure line 7714 remains neutral or closed. The pressure line 7712 remains neutral, or closed, or negative to fully deflate the valve 7706. This configuration effectively applies negative pressure to the drainage catheter by inflating the compliant portion 7704 while shutting off fluid flow to the drainage tube 7724. This configuration Fig.77A Shown in.

[0444] Fig.77A The configuration lasts only a short time, such as about 0.5 to 1 second or about 1-3 seconds or about 3-5 seconds. The patient-side valve 7706 is then closed by applying positive pressure to the pressure line 7712, and the drainage-side valve is opened by reducing the pressure in the pressure line 7716 to neutral or applying negative pressure to the pressure line 7716. The volume of the compliant portion 7704 is reduced by increasing the pressure in the pressure line 7718 to neutral or applying positive pressure to the pressure line 7718. Positive pressure may also be applied to the pressure line 7714. This configuration is Fig.77B . In this configuration, the fluid in the drainage lumen 7720 and the drain line 7724 is flushed with fluid (gas / liquid) through the pressure line 7714 and / or by the positive pressure applied by the reduction in volume of the compliant portion 7704, thereby effectively flushing urine through the drainage line. After flushing, the system is brought back to the neutral position, in which both the patient-side valve 7706 and the drain-side valve 7708 are open and the compliant portion 7704 is in the neutral position.

[0445] Fig.78 Shown with Fig.72The embodiment shown is similar but has a positive pressure vent tube 7802 instead of an embodiment of a separate vent tube. The vent 7804 is in fluid communication with the cavity of the positive pressure vent tube 7802 and is in a line. The vent 7804 is also in fluid communication with the barb region of the urine drainage chamber 7808 and is connected to the region 7808 through an opening 7806. Fluid / air / gas under positive pressure passes through the outlet 7804, through the opening 7806, and enters the region 7808 that is in fluid communication with the drainage chamber. In other words, the positive pressure fluid / air / gas passes through the filter to reach the inside of the barb. The wetting of the vent 7804 is prevented by controlling the positive pressure in the positive pressure tube and through the vent 7804 and the negative pressure of the drainage chamber. In some embodiments, the pressure in the barb region of the urine drainage chamber 7808 is close to about zero. The vent 7804 can be anywhere along the length of the positive pressure vent tube 7802. Fig.78 The illustrated embodiment may or may not include a one-way valve between the filter and the opening. The positively pressurized fluid / air / gas may be passed through the vent continuously, intermittently, sporadically, etc. The positively pressurized fluid / air / gas may be passed through the vent as a stream, jet, or pulse.

[0446] Pressure can be used to clear filters throughout the system (whether in the barbs, positive pressure tubes, vent tubes, reservoirs, or elsewhere). For example, a jet of pressurized air or gas can be used to traverse the filter to clear it if it is wetted or to prevent it from being wetted. Alternatively, a steady or intermittent stream of air or gas can be used.

[0447] Fig.79 An embodiment is shown in which the area in the barb that is in fluid communication with the urine drainage lumen has a larger volume. Fluid 7902 (such as urine) flows from the drainage catheter into a large container 7904 and then into the urine drainage lumen. The reservoir 7904 is large enough that it is impossible for it to be completely filled with liquid at any time. The volume of the reservoir that is not filled with liquid will be filled with air or gas. A one-way valve 7908 may also exist. Because the reservoir 7904 always has some air / gas in it, the vent 7906 can be positioned so that it rarely comes into contact with the urine / fluid in the reservoir. In other words, the vent can be on one side of the bubble in the reservoir. There may be more than one vent to ensure that at least one vent is always in fluid communication with the bubble in the reservoir. In some embodiments, the volume of the reservoir 7904 may be greater than the volume of the lumen of the drainage tube.

[0448] Fig.80A and Fig.80BAn embodiment is shown where the area of ​​the vent is very large. The vent 8002 is shown here as a large flat circle or disc, however the vent can be of any shape and size. The vent can be flat or curved, such as to wrap around the barb area. The embodiment shown here has one opening 8004 and one-way valve 8006, however other embodiments may have more than one opening and may or may not have a valve. Some embodiments may have a vent greater than about 1 cm 2 Some embodiments may have a filter surface greater than about 2 cm 2 Some embodiments may have a filter surface of about 3 to about 4 cm 2 Alternatively, some embodiments may have a filter surface of about 2 to about 4 cm 2 Alternatively, some embodiments may have a filter surface of about 4 to about 6 cm 2 Alternatively, some embodiments may have a filter surface of about 6 to about 10 cm 2 filter surface.

[0449] Fig.81 Embodiments with replaceable vents are shown.Replaceable vents 8102 are shown here in embodiments with positive pressure tube 8104 and one-way valve 8106, but embodiments may also exist without positive pressure tube and / or valve.Replaceable vents 8102 may be removed and replaced by connecting mechanisms (such as Luer locks, snap locks, slide-in locks, press fits or any other suitable mechanisms).Vent replacement may be performed periodically (such as once a day) or as needed (such as when controller warns user that vent no longer works correctly or when user notices that vent no longer works).Vents may have chemicals sensitive to urine or the composition of urine, which changes color to indicate that it has been wetted.For example, pH-sensitive or other chemical or property-sensitive paper may be used in replaceable vents, which changes color and is visible to users.Replaceable vents may be disposable.

[0450] Fig.82A and Fig.82B An embodiment is shown in which the filter is flexible. In this embodiment, the filter 8202 can be flexible or deformable, i.e., it can be convex / concave, or loose in its housing. If the filter is wet or contaminated, movement of the flexible filter 8202 can help unclog the filter. The movement of the filter can be controlled by positive pressure via a positive pressure tube 8204, by negative pressure via a urine drainage lumen, a valve 8206, or any one or combination of the above. Some embodiments may also include a mechanical mechanism to agitate, shake, vibrate, bend and / or move the filter 8202. For example, Fig.82AAn example of an embodiment is shown where negative pressure in the urine drainage lumen causes the filter to be recessed. Fig.82B The same example is shown after positive pressure is applied to the vent via the positive pressure tube 8204. The pressure within the vent housing 8208 can be controlled by the rupture pressure of the one-way valve or by the relative negative pressure in the urine drainage cavity and the positive pressure within the positive pressure tube. Similar embodiments can also exist where the filter is not flexible, but the pressure is controlled within the vent housing 8208 in a similar manner to keep the filter dry.

[0451] Alternatively, the filter (flexible or otherwise) may be mechanically (manually or automatically) wiped or scraped. Alternatively, the filter may include chemicals that inhibit protein adhesion and / or accumulation, such as enzyme detergents. Alternatively, the filter may include chemicals that inhibit biofilm, such as antimicrobial agents.

[0452] Fig.83 An embodiment with multiple stacked filters is shown. Filters of different pore sizes can be used in a stacked manner. For example, a coarse pore filter 8304 can protect a fine pore filter 8302 from being wetted. Of course, the coarse pore filter 8304 can be placed between the fluid / urine and the fine pore filter 8302. In this configuration, the liquid / urine will need to pass through the coarse pore filter 8304 to contact the fine pore filter 8302. More than two filters can be stacked in this manner, which have graded pore sizes, or similar pore sizes, or any pore size. For example, increasingly fine pore filters can be stacked so that the finer pore filters are further away from the urine / liquid. Alternatively, one or more coarse pore filters of the same or different pore sizes can be placed between the urine / liquid and the fine pore filter. A one-way valve may or may not be present. The pore size of the coarse pore filter 8304 can be about 10 microns. Alternatively, the pore size of the coarse pore filter 8304 can be about 10 to about 20 microns. Alternatively, the pore size of the coarse filter 8304 can be about 10 to about 30 microns.

[0453] Fig.84An embodiment is shown in which a continuous positive pressure is applied to the barb region by the fluid in the positive pressure tube 8402. The positive pressure tube is under substantially constant positive pressure so that the fluid (preferably air / gas) passes continuously through the opening 8404. The positive pressure applied to the fluid in the interior 8406 of the barb is controlled so that the fluid does not flow back into the urine drainage catheter. In other words, the negative pressure applied to the fluid in the interior 8406 is always greater than or approximately equal to the positive pressure applied to the fluid in the interior 8406. The positive pressure can be controlled at the controller, and / or it can be controlled by the size of the opening 8404, for example, by making the size of the opening 8404 very small. For example, the diameter of the opening 8404 can be less than about 1mm. Alternatively, the diameter of the opening 8404 can be less than about 2mm. Alternatively, the diameter of the opening 8404 can be less than about 3mm. Alternatively, the diameter of the opening 8404 can be less than about 4mm.

[0454] Fig.85 An embodiment with an accordion-like vent is shown. The vent 8502 in this embodiment is shaped like an accordion. The vent can be compressed in the direction of the double arrow. This compression can clear blockages / wetting, etc. from the vent. Compression can be done manually, automatically / mechanically and / or using pressure (negative and / or positive pressure) in the vent area.

[0455] Fig.86 An embodiment with a single vent and multiple openings is shown. In this embodiment, more than one small opening 8602 separates the urine drainage cavity from the vent 8604. The small openings prevent fluid from contacting the vent 8604. Multiple openings can be used as redundancy so that if one or more openings become blocked, the other openings remain open. The openings can also be used to control the passage of air / gas / fluid through the vent 8604 - more holes result in less resistance to airflow, fewer holes result in higher resistance to airflow.

[0456] Any of the embodiments herein may include physiological pressure measurements, or they may be used without physiological pressure measurements. For example, Figure 67 to Figure 86 The illustrated system and other embodiments may not include a thermistor nor a pressure chamber and may be used with a standard Foley catheter.

[0457] In some embodiments, pressure can be measured at the positive pressure tube / drainage tube junction. Alternatively, pressure can be measured at the sensing Foley catheter / drainage tube junction or in the region of the barb. Pressure can be measured at any of these positions by merging an extra tube or cavity, which is in fluid communication with the pressure tube / drainage tube junction, or in fluid communication with the region of the barb at one end, and in fluid communication with a pressure sensor or transducer at the other end. For example, the pressure measurement cavity can be in fluid communication with a controller accommodating a pressure sensor at one end (sensor end), and in fluid communication with the positive pressure tube / drainage tube joint junction at the other end (sensing end). A pressure-sensitive membrane can be present at the sensing end to prevent urine contamination of the cavity.

[0458] Air plugs may also be detected so that they can be optimally cleared and / or avoided. Using any of the embodiments herein, the controller may apply a slight positive or negative pressure to the urine drainage lumen and sense the reaction. A diminished reaction may indicate the presence of an air plug, and a less diminished reaction may indicate less of an air plug because air is more compressible than urine. If excessive air plugs are detected, the controller may initiate air plug clearance, for example by applying negative pressure to the drainage lumen.

[0459] In some embodiments, the valve may be present anywhere in the system, including within the positive pressure line or within the reservoir.

[0460] The ventilation tube can be a separate tube from the drain tube and can be inserted in the drainage lumen or even in the Foley catheter. Fig.87 An embodiment of a sensing Foley catheter system is shown in which the vent is within the urine drainage tube. This type of embodiment has the following advantages: It can be used with any standard drainage tube. The vent essentially places the vent anywhere within the drainage lumen (either within the drainage tube or within the Foley catheter). The vent is slidably inserted within the drainage tube and / or the Foley catheter and can be moved at any time.

[0461] exist Fig.87 In the illustrated embodiment, the vent tube 8704 may be open at one end (air end "8708") to a vent / filter 8702 within the collection reservoir (which is open to atmospheric pressure) and at the other end ("urine end" 8710) within the urine drainage lumen 8706. Although the vent tube is shown here as terminating within a barb at the base of the Foley catheter, the vent tube may terminate anywhere within the urine drainage lumen, including within the drainage tube or anywhere within the Foley catheter. The vent tube may remain in one position or may be moved within the system to maximize urine drainage and minimize air locks and damage to the bladder caused by negative pressure within the bladder.

[0462] Fig.88 Another embodiment of a sensing Foley catheter system is shown in which a vent tube 8802 has a vent / filter 8804 at the "urine end" of the tube and is open to the atmosphere on the "air end" 8806 of the tube. There may also be filters / vents at both ends. The "air end" of the vent tube can exit the drainage cavity through a y-arm adapter, a stopcock, or other standard means. The "air end" of the vent tube can exit the system from the collection container through a channel or port incorporated into the collection container. Again, the vent tube can be used with any urine drainage tube, including standard urine drainage tubes.

[0463] Fig.89 Shown with Fig.88 The embodiment shown is similar to the embodiment with the addition of a positive pressure tube 8902.

[0464] Fig.90 , Fig.91A and Fig.91B The vent tube is shown at different locations within the sensing Foley catheter system. Fig.90 In the embodiment, the "urine end" 9002 of the vent tube is only partially within the drainage tube. For example, the vent tube can be inserted through about half of the drainage tube. Or, for example, the vent tube can be inserted through about one-third of the drainage tube. Or, for example, the vent tube can be inserted through about two-thirds of the drainage tube. Fig.91A In FIG. 9 , the “urine end” 9002 of the vent is within the Foley catheter. The location of the “urine end” of the vent is determined based on maximizing urine drainage and minimizing the effect of air lock on drainage and minimizing negative pressure within the bladder. Fig.91B In the embodiment, the vent tube is inside the drainage tube and is connected at one end at or near the barb and terminates at about 6"-24" along the drainage line. The vent tube may or may not include a filter or valve.

[0465] In some embodiments, after an initial volume of urine is drained from the bladder, the vent tube is connected to a sensing Foley catheter system.

[0466] The vent tube may incorporate one or more filters / vents. The vent tube may incorporate one or more than one incisions that are in fluid communication with the lumen of the vent tube and ultimately in fluid communication with a vent / filter in a collection reservoir or elsewhere. Multiple filters / vents or multiple incisions may surround the vent tube or along the vent tube or around the vent tube and along the vent tube. The vent tube may include UV light directed to the filter, the "urine end" or elsewhere to maintain sterility.

[0467] Fig.91C and Fig.91D Other embodiments are shown where the ventilation lumen is concentric with the urine drainage lumen. Fig.91C The embodiment shown may be similar to Fig.87 The ventilation and drainage tubes are shown, wherein the ventilation tube 8704 is inside the drainage cavity 8706. Fig.91D The illustrated embodiment shows an embodiment where the drainage lumen 8706 is inside the vent lumen 8704. The vent lumen in any of the embodiments disclosed herein may extend along part or all of the length of the drainage lumen.

[0468] The various cavities of the system can be combined in one or more tube extrusions. The tubes can be separate, or two or more tubes can be connected to each other to prevent kinking. For example, 4 tubes can be connected to each other along a considerable portion of their length, including cavities for drainage, exhaust, temperature and pressure measurement. Alternatively, 5 tubes can be connected. To increase stiffness, a tube can be included. The tube cavity can include a stiffening wire or mandrel for increasing stiffness. The tubes can be co-extruded or extruded individually and connected along their length at a later time. The cavities can be connected along all or part of their length. For example, a urine drainage tube and possibly a vent tube can be separated from the temperature and pressure tube at one or more points along the length of the drainage tube. This allows the urine drainage tube (possibly together with the vent tube) to be clamped closed without affecting the temperature and pressure function of the system.

[0469] Fig.92A and Fig.92B Some possible embodiments of the drainage cavity are shown, for example Fig. 10A Drainage lumen 1012 is shown. Fig.92A A drainage cavity with a collapsible / expandable portion 9202 is shown. Portion 9202 can be made of a lower durometer material than the rest of the drainage cavity, allowing it to collapse or expand depending on the internal pressure. The cavity will collapse to a lower internal area / volume at lower or negative pressures and expand at higher or positive pressures. Gas lock can be reduced by changes in cavity volume at different pressures. This type of cavity can be incorporated into any of the embodiments herein.

[0470] Fig.92B An embodiment of a drainage chamber comprising two chambers is shown. The inner chamber shown here is a negative pressure / urine drainage chamber 9204. The outer chamber is a positive pressure chamber 9206. Between the two chambers is an opening 9208. The opening may or may not include a filter membrane. The two chambers may be concentric, as shown here, or adjacent. The positive pressure chamber serves as essentially the same positive pressure vent shown elsewhere in this document. When negative pressure is applied to the drainage chamber 9204, positive pressure is either constantly or periodically applied to the positive pressure chamber 9206, resulting in the clearing of the drainage chamber 9204.

[0471] Figures 93A to 93EAnother embodiment of a drainage lumen is shown. This embodiment also includes a drainage lumen 9302 and a positive pressure lumen 9304. In this embodiment, the positive pressure lumen 9304 is expandable and collapsible. In the expanded state of the positive pressure lumen, it partially or completely blocks the drainage lumen. In the collapsed state of the positive pressure lumen, the drainage lumen is substantially open, allowing fluid to flow freely through the drainage lumen. Fig.93A The drainage lumen is shown in a closed state adjacent the patient side of the drainage tube. Fig.93B The drainage lumen is shown further away from the patient in a closed state. Fig.93C The drainage lumen is shown in an open state.

[0472] Fig.93D A longitudinal view of the drainage tube is shown in the closed state. Fig.93E A longitudinal view of the drainage tube in the open state is shown. Fig.93C and 93E As shown, the positive pressure chamber 9304 collapses and does not substantially block the drainage chamber 9302, allowing urine to flow freely from the body to the reservoir. When the air plug or other blockage removal of the drainage tube is performed, the positive pressure chamber is inflated to push urine / liquid along the drainage tube toward the collection reservoir. The patient end 9306 of the positive pressure chamber can have a larger diameter and / or lower hardness (durometer) than the reservoir end 9308 of the positive pressure chamber. This allows the patient end of the positive pressure chamber to be inflated before the reservoir end is inflated. In this way, the drainage chamber is first blocked at the place closest to the patient, and then either substantially all of the drainage chamber is filled or a portion of the drainage chamber is filled with the remaining portion of the positive pressure chamber. The positive pressure chamber can be inflated at the patient end or the reservoir end of the drainage tube. One or more filters may be present along the length of the drainage chamber.

[0473] Embodiments of sensing Foley catheter systems may include the ability to measure pressure within the bladder via a pressure balloon connected to the Foley catheter or via a pressure balloon or other pressure sensor inserted within the drainage tube and / or drainage lumen of the Foley catheter. See, for example, Figures 94A-94C .

[0474] Figures 94A-94CAn embodiment of a sensing Foley catheter system is shown in which the pressure sensor is in fluid communication with the urine cavity of the Foley catheter, but may reside on a separate catheter. A Foley-type catheter 9402 is shown having a urine cavity 9404 and a urine drainage opening 9406. A small pressure sensing catheter 9408 having a pressure sensing bladder 9410 is shown inside the urine drainage cavity of the Foley-type catheter. The outer diameter of the pressure sensing catheter is small enough so that it fits within the urine drainage cavity of the Foley-type catheter. For example, the outer diameter of the pressure sensing catheter may be less than about 4 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 3 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 2 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 1 mm.

[0475] The pressure sensor on the pressure sensing catheter can be near the distal end of the pressure sensing catheter, or it can be anywhere along the length of the catheter. The pressure sensor can be a pressure sensing balloon, or it can be any type of pressure sensor, such as a piezoelectric sensor, a mechanical sensor, etc. In the case of a pressure sensing balloon, the inflated balloon can be smaller than the inner diameter of the urine drainage lumen of the Foley-type catheter, or the inflated balloon can be large enough to fill the urine drainage lumen of the Foley-type catheter.

[0476] The inflated pressure sensing balloon can fill the urine drainage lumen of the Foley-type catheter for better pressure measurement. The pressure sensing balloon can be deflated periodically or partially to allow urine to flow from the bladder through the Foley-type catheter. Control of the pressure sensing balloon inflation cycle can be controlled by the controller of the present invention.

[0477] Fig.94B An embodiment of a pressure sensing catheter is shown having both an occlusion balloon 9424 and a pressure sensing balloon 9426. The occlusion balloon occludes the urine drainage lumen so that the pressure sensing catheter only senses the pressure between the occlusion balloon and the bladder, which can more accurately and precisely measure the pressure within the bladder.

[0478] The outer diameter of the inflated pressure sensing bag can be less than about 5 mm, alternatively, the outer diameter of the pressure sensing catheter can be less than about 4 mm, alternatively, the outer diameter of the pressure sensing catheter can be less than about 3 mm, alternatively, the outer diameter of the pressure sensing catheter can be less than about 2 mm, alternatively, the outer diameter of the pressure sensing catheter can be less than about 1 mm.

[0479] Fig.94CA standard Foley-type catheter having a retaining sac 9412, a urine drainage opening 9406, a retaining sac port 9414, and a urine drainage port 9416 is shown. An adapter 9418 is shown connected to the urine drainage port 9416. The adapter 9418 has two ports, a urine drainage port 9420 and a secondary urine cavity port 9422. A pressure sensing catheter 9408 is shown in the urine cavity port 9422. In this way, the pressure sensing catheter is in fluid communication with the urine drainage cavity of the Foley-type catheter. The proximal end of the pressure sensing catheter 9408 is connected to a pressure sensor (such as a pressure transducer), similar to other embodiments herein. The pressure sensing catheter 9408 may have only a single cavity - the sensing sac cavity, or it may include other cavities. In the case where the pressure sensor of the pressure sensing catheter is a mechanical pressure sensor, the pressure sensing catheter may have no cavity, or the pressure sensing catheter may have a sac for sealing the urine drainage cavity of the Foley-type catheter.

[0480] A pressure sensing catheter may also be inserted through the urine drainage lumen of the drainage tube.

[0481] Pressure measurements can be made over time using a pressure sensing catheter and analyzed in any manner disclosed herein. To improve pressure measurements, the drainage port 9420 can be periodically closed or blocked. Blockage of the drainage port 9420 can be accomplished mechanically, with a stopcock or valve, or automatically, for example, with a solenoid valve connected to a controller. An advantage of this embodiment is that the pressure sensing catheter 9408 can be used with any Foley-type catheter to measure pressure. In addition, the pressure sensing catheter 9408 can be inserted into and removed from a Foley-type catheter after the Foley-type catheter is already in place in the patient's bladder.

[0482] The pressure sensing catheter can be combined with the vent tube shown in other figures. In this way, the pressure sensing, urine drainage, anti-gas plug, venting components of the sensing Foley catheter system can be used with any standard Foley catheter and drainage tube. Alternatively, the pressure sensing catheter / vent tube combination can be used with a more specialized Foley catheter and / or drainage tube.

[0483] In any embodiment including any type of air lock clearing mechanism, air lock clearing can be performed continuously, periodically (either at regular intervals or from time to time), on demand, or when an air lock condition is sensed. The air lock clearing mechanism prevents or reduces air locks. For example, the air lock clearing mechanism can reduce air locks so that air locks are cleared at least once every 60 minutes. Alternatively, the air lock can be cleared at least once every 45 minutes. Alternatively, the air lock can be cleared at least once every 30 minutes. Alternatively, the air lock can be cleared at least once every 20 minutes. Alternatively, the air lock can be cleared at least once every 10 minutes. Alternatively, the air lock can be cleared at least once every 5 minutes. Alternatively, the air lock can be cleared at least once every 1 minute.

[0484] In any embodiment including a vent or filter or vent tube as part of the barb region or drainage tube, fluid (i.e. urine) drainage may be discontinuous, i.e. interrupted, due to the introduction of gas / air into the drainage lumen via the vent / filter / vent tube. In other words, the drainage lumen may alternate between liquid (i.e. urine) and gas.

[0485] In any embodiment comprising measuring urine output in real time, real time can mean that the reported urine output measurement is accurate to within about 1 minute. Alternatively, real time can mean that the reported urine output measurement is accurate to within about 5 minutes. Alternatively, real time can mean that the reported urine output measurement is accurate to within about 10 minutes. Alternatively, real time can mean that the reported urine output measurement is accurate to within about 20 minutes. Alternatively, real time can mean that the reported urine output measurement is accurate to within about 30 minutes. Alternatively, real time can mean that the reported urine output measurement is accurate to within about 60 minutes.

[0486] Air bubbles in urine - prevent air bubbles and / or influence on measurement

[0487] Sometimes, protein or other components in the urine can cause excessive foaming in the urine within the drainage lumen and / or collection container, which can cause problems such as wetting of the vent / filter, urine entering the overflow area of ​​the collection container, inaccurate measurements, etc. Some embodiments of the sensing Foley catheter system incorporate an anti-bubble mechanism.

[0488] In some embodiments (such as those incorporating a positive pressure tube), precise control of the pressure within the urine drainage may be achieved. A slight positive pressure may occasionally be applied within the drainage system (i.e., the drainage lumen and / or collection chamber) to collapse any bubbles present or prevent bubble formation.

[0489] Surfactants such as silicone, dimethicone or other suitable materials may be added to the system. For example, slowly dissolving silicone capsules may be added to the collection reservoir. Alternatively, a surfactant coating may be used on the interior of the drainage lumen and / or the interior of the collection container.

[0490] Air bubbles may be eliminated or reduced at the junction of the drainage tube and the collection container. Fig.95A -C. For example, the base of the drain tube can be S-shaped (such as in the drain tube under the sink), and the inner diameter of the drain tube can expand near the junction with the collection container or elsewhere. The drain tube can be bulb-shaped or conical. Fig.95C As shown, the drainage cavity can become annular. In this embodiment, the fluid is forced to flow down the side of the inclined conical surface to reduce bubbles, similar to how beer is poured along the side of a glass instead of into the center of the glass to reduce beer foam. The bubble reduction feature shown here is at the base of the drainage tube, but can be in any part of the drainage tube or system. In some embodiments, the drainage cavity can be flattened to force urine to contact the surface again. For example, the urine drainage cavity may be flattened to less than about 1 mm. The urine drainage cavity may be flattened to less than about 2 mm. The urine drainage cavity may be flattened to less than about 3 mm.

[0491] Urine can also be forced to a point, such as with Fig.96A The cone can have an angle as shown here, or can be more curved. The cone shape generally transitions from a small area to a large area, and / or from a large area to a small area. This and other bubble reduction mechanisms can also be within the collection container. For example, as Figures 96B-96D As shown, angled baffles can be incorporated into the collection reservoir to force the fluid down the angled surface. The angled surface can extend all the way to the bottom of the collection container, or only partially into the collection container. Different angles can be used, such as from about 10 degrees to about 80 degrees.

[0492] like Fig.96C and Fig.96DAs shown in the embodiments of , angled baffles may also be preferred for improving the accuracy of urine volume measurement, especially in critical care conditions where patients are required to have low urine output and continuous measurement of urine output (ml / min or ml / sec) to diagnose the patient's susceptibility to the onset of AKI, sepsis or other symptoms. For a given urine volume, accurate measurement of small urine volumes is better measured in a conical or angled baffle due to the higher height of the urine column compared to a flat bottom baffle or cassette. An ultrasonic transducer or similar transducer on the controller can more reliably measure the height and provide accurate measurement of urine volume and the rate of urine output, especially when the patient's kidneys are injured and produce very little urine. In addition, compared to a cassette with a flat surface, for small urine volumes, an angled baffle or cassette (urine collection chamber) may be less sensitive to changes in the inclination of the controller and reduce measurement errors.

[0493] Fig.97A An embodiment of a sensing Foley catheter system is shown in which the drainage lumen extends into the collection container / cassette so that the fluid drains into the collected fluid, typically below the liquid surface. The drainage end of the drainage lumen 9722 can be cut at an angle to prevent the tube from abutting the bottom of the cassette, which could prevent fluid flow. The angled cut 9724 can be about 45 degrees, about 10-80 degrees, or any suitable angle. Other shapes can be used at the drainage end of the drainage lumen to achieve the same result. For example, Fig.97B A drainage lumen is shown whose conduit is castellated at the drainage end. The castellations 9726 may have any shape, including circular, rectangular, triangular, fan-shaped, etc.

[0494] Fig.97C An embodiment of a sensing Foley catheter system is shown in which the drainage lumen extends into the cassette and includes a flat region 9728. In this embodiment, the cross-sectional area of ​​the drainage lumen can remain the same, increase or decrease in the flat region, however preferably at least one dimension is increased to force an increased surface area to contact the fluid flow. The flat region can direct the flow downward, such as Fig.97C As shown, or the flat portion can be angled to force the fluid to flow in contact with at least one side of the inner surface of the cavity. Alternatively or in addition, an angled baffle such as Fig.97D Baffle 9730 is shown. The angle of baffle 9730 can be about 45 degrees, about 10-80 degrees, or any suitable angle. Angled baffles or flat areas can be used with any drainage tube / lumen design shown herein.

[0495] Fig.98A An embodiment of a sensing Foley catheter system is shown in which the drainage lumen area increases and decreases. The bulb 9832 can be located above the cassette, within the cassette (e.g. Fig.98DThe area above and below the bulb-shaped object may be substantially the same, or the area below the bulb-shaped object may be smaller than the area above the bulb-shaped object (as shown in FIG. Fig.98B ). The reduced drainage lumen area portion 9834 can be relatively short, for example, portion 9834 can be approximately 1 mm-10 mm long. Alternatively, portion 9834 can be approximately 10 mm-20 mm long. Alternatively, portion 9834 can be approximately 10 mm long. Fig.98C An embodiment is shown where the narrow portion 9836 includes more than one reduced area fluid drainage lumen. This allows for increased surface contact of the drainage lumen without significantly reducing the area of ​​the drainage lumen. The narrow portion 9836 can be used in conjunction with the bulb 9832 or without the bulb.

[0496] Note that any of the bubble reduction embodiments disclosed herein may be used anywhere in the drainage lumen, including drainage tubes outside of the cassette and drainage tubes / lumens within the cassette. Fig.98D Shown with Fig.98B An embodiment similar to the embodiment shown, wherein the bulb-shaped object is within the box.

[0497] Fig.99A An embodiment of a sensing Foley catheter system is shown in which at least a portion of the drainage lumen is roughened to disperse and / or burst air bubbles.

[0498] Fig.99B and Fig.99C Another embodiment to reduce bubbles is shown. In this embodiment, a grid, honeycomb or mesh is inside the base of the drain tube. The mesh helps break up bubbles and can be compressed periodically to clear fluid from the area and also help break up bubbles.

[0499] Alternatively or additionally, a flat mesh may be inserted anywhere within the system, such as at the drainage tube / collection container junction.

[0500] In some embodiments, the cassette and / or drainage chamber may be vibrated continuously or intermittently to break up air bubbles.

[0501] Fig.100A-C shows an embodiment incorporating a floating or non-floating plate to compress or break up bubbles at or near the surface of the urine in the collection container. The plate may simply float on the surface and passively rise and fall with the volume of urine in the container, or the plate may actively move up and down. The plate may also be fixed in place. The plate may be porous or solid. In embodiments where the plate is on the surface of the fluid, the plate may also be used for urine output measurement. The position of the plate may be identified by ultrasound, visual means (such as in a camera), laser, or other techniques. The volume of the fluid in the collection container may be determined directly from the level of the fluid, which may be determined by the position of the plate.

[0502] The interior of the cassette may be rectangular or otherwise shaped. For example, the sides of the interior of the cassette may taper inwardly toward the bottom so that there is a larger top surface of urine relative to the volume of urine in the cassette. This may result in more accurate urine volume measurements at a smaller volume.

[0503] Some embodiments may include a volume baffle at a set volume mark (e.g., at 50 ml). The volume baffle may be similar to Fig.23 The baffle 2302 shown is shown, except that it will be at a predetermined volume position. When the top surface of the urine volume in the cassette is at or near the volume baffle, the ultrasonic signal is stronger than it would be otherwise. For example, the volume baffle can be positioned so that when the top surface of the volume of urine is at about 50 ml (or other set volume), the top surface of the urine volume will be at or near the volume baffle. The ultrasonic signal is strongest when the two surfaces (urine and volume baffle) are close to each other or in contact with each other.

[0504] Some embodiments may include a waveguide to help account for the tilt of the reservoir. For example, the ultrasound signal may be directed within a cylinder with flat or curved sides to direct the ultrasound waves toward the surface of the fluid within the reservoir so that they will be reflected back. The waveguide may extend fully or partially within the reservoir. The waveguide may extend between the ultrasound transducer / sensor and the surface of the fluid.

[0505] In some embodiments, the ultrasonic transducer / sensor may be flat, and in some embodiments, the surface of the ultrasonic transducer / sensor may be curved, such as a convex curve. The convex curve helps spread the ultrasonic signal to more corners, which helps ensure that some corners are reflected by the surface of the fluid in the reservoir.

[0506] Some embodiments include a controller that uses an accelerometer to measure the tilt of the reservoir, and then uses the tilt angle to calculate the volume of fluid remaining in the reservoir (i.e., in the low corners of the reservoir) after the fluid has been emptied from the reservoir. The calculated volume remaining in the reservoir can be added to the total urine output calculation to improve accuracy.

[0507] Fig.101A An embodiment of a sensing Foley catheter system is shown that includes valves both at the drainage port 10102 and at the entry point 10104 where the drainage tube is connected to the collection container. This allows the controller to periodically pressurize the collection container, which can reduce bubbles and / or aid in draining the collection container. The entry valve can also result in a more accurate measurement of urine output because the flow of urine into the collection container can be stopped by the controller during urine emptying.

[0508] Fig.101B An embodiment of a collection container is shown in which the urine overflow path becomes longer and / or convoluted / tortuous and / or narrow. This configuration makes it more difficult for air bubbles to flow into the overflow path, which can lead to inaccurate measurements of urine output. The overflow path can include one or more path angles greater than 45 degrees.

[0509] Fig.101C An embodiment of a collection container is shown in which the fluid path (indicated by the dashed arrow) between the urine in the reservoir and the cassette pump interface 1148 is convoluted and long to prevent wetting of the interface 1148. The cassette pump interface 1148 may include a gas permeable, liquid impermeable filter. The fluid path may be approximately 6-12 cm long. Alternatively, the fluid path may be between approximately 3 and 6 cm long. Alternatively, the fluid path may be longer than approximately 12 cm. Alternatively, the fluid path may be between approximately 3 and 6 cm long. Alternatively, the fluid path may be longer than approximately 20 cm.

[0510] Fig.101D Another embodiment of a collection container is shown in which the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is spiral and long to prevent wetting of the interface 1148. The spiral path may include a small diameter tube 10108 that is coiled or pleated as all or part of the fluid path. Preferably, the spiral path spirals in three dimensions.

[0511] Fig.101E Another embodiment of a collection container is shown in which the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is convoluted and long to prevent wetting of the interface 1148. This embodiment includes both a small diameter tube 10108 and a convoluted path molded into the cassette. The convoluted path can be partially molded, partially tubing, or fully tubing or fully molded.

[0512] The inner diameter of the small diameter tube 10108 can be about 1.8-2.0 mm. In some embodiments, the ID can be about 1.6-1.8 mm. In some embodiments, the ID can be about 1.4-1.6 mm. In some embodiments, the ID can be about 1.2-1.4 mm. In some embodiments, the ID can be about 1.0-1.2 mm. In some embodiments, the ID can be about 0.8-1.0 mm. In some embodiments, the ID can be about 0.5-0.8 mm. In some embodiments, the ID can be about 0.2-5 mm. In some embodiments, the ID can be less than about 4 mm. In some embodiments, the ID can be less than about 3 mm. In some embodiments, the ID can be less than about 2 mm.

[0513] Some embodiments include drainage tubes with small lumen diameters. For example, in some embodiments, the lumen diameter is about 2 mm. In some embodiments, the lumen diameter is about 1 mm. In some embodiments, the lumen diameter is about 3 mm. In some embodiments, the lumen diameter is less than about 2 mm. In some embodiments, the lumen diameter is less than about 1 mm. In some embodiments, the lumen diameter is less than about 3 mm.

[0514] In some embodiments, drained urine can be used to "wash" air bubbles in the drainage tube or collection reservoir. Urine can be circulated back into the drainage tube to increase the volume in the drainage tube and help "wash" air bubbles in the tube and / or reservoir. The controller compensates for the recycled urine when calculating the urine output volume.

[0515] In some embodiments, pressurized air can be introduced into the drainage tube and / or collection container. The forced air bursts and / or compresses the bubbles and also forces urine upward against the surface of the system to reduce bubble formation. The cross-sectional area of ​​the drainage tube can decrease, remain the same, or increase as the drainage tube transitions to the flat portion.

[0516] Leveling

[0517] In embodiments where the urine volume is measured within the collection container using ultrasound, it is important that the ultrasound has a surface (i.e., the surface of the volume of urine) at approximately 90 degrees to the ultrasound sensor. If the system is tilted even a few degrees, the ultrasound sensor may not be able to sense the surface of the urine, and therefore an accurate measurement of the urine volume may not be obtained. To compensate for this, the collection container or base / controller can be connected to the bed via an automatic leveling attachment (e.g., an attachment on rollers) so that gravity automatically levels the base when the base is connected.

[0518] In certain embodiments, the micro-angles in the system are processed by producing a "rough" surface on the urine volume in the collection reservoir. The "rough" surface provides multiple angles for ultrasonic reflection, some of which are approximately 90 degrees with the ultrasonic sensor / transducer. Roughness can be produced by using air or other gases to bubble urine, by vibrating the collection reservoir and / or urine. Vibration can be achieved mechanically, ultrasonically, etc. A floating plate floating on the surface of urine can be used, which has a rough lower surface, a concave lower surface, or a convex lower surface. When urine is discharged, floating beads can be in the reservoir, and the floating beads are too large in diameter to leave the reservoir, so that when urine is discharged, the floating beads remain in the reservoir. Netted narrowed small diameter openings or other mechanisms can be used to prevent beads from entering the overflow area. In addition, as mentioned above, angled baffles or angled wall or tapered wall cassettes (or urine collection chambers) can also be used to accurately measure urine volume.

[0519] Pressure bladder filling

[0520] A very small amount of air or fluid may be necessary to adjust the pressure of the pressure bladder to fill it for optimal pressure sensing measurements. Because of this, an air / gas / fluid restrictor may be utilized between the filling fluid and the pressure bladder. The restrictor allows the filling pump to operate with a smaller volume of air for more accurate filling of the pressure bladder. The restrictor may include a foam insert, a narrowing of the fluid cavity, or any other suitable restrictor.

[0521] General Improvements

[0522] In some embodiments, sensors on the bed, on the patient, in the sensing Foley catheter system, or elsewhere sense when the patient is supine or not supine. The pressure measured in the bladder will increase when the patient is not supine, and may adversely affect the data analyzed by the controller. As a result, the controller can ignore the pressure data collected when the patient is not supine, or stop collecting pressure data during this time. Alternatively, the pressure measurement itself can be used to sense when the patient is not supine. A sharp increase in pressure or an increase above a certain threshold can indicate that the patient is sitting up, moving, coughing, etc. Different pressure distributions can indicate different events. Patient rolling can be tracked in this way to prevent bedsores.

[0523] In some embodiments, EKG measurements obtained through a wire connected to a sensing Foley catheter system or obtained independently are used to synchronize the heartbeat measured by the heart rate in the bladder with the EKG.

[0524] In some embodiments, the angle of the bed can be used by the controller as an input parameter for a calculated result, such as IAP or APP. For example, increasing the body angle (raising the patient's head level) will result in an increased IAP. This increase may be different for a healthy patient than for a less healthy patient. As a result, determining the IAP at different bed angles can provide additional information about the patient's health. In addition, the IAP can be reduced by lowering the head level, which can temporarily stabilize a patient with a high IAP.

[0525] In some embodiments, the sensing Foley catheter will have at least one pressure sensor or cavity in fluid communication with an external pressure sensor. The pressure sensor will allow rapid or high frequency sensing of the pressure in the cavity (ideally faster than 1 Hz) to allow monitoring of physiological signals in the cavity. In some embodiments, the pressure cavity can be pressurized and / or depressurized manually or automatically, while the pressure is monitored continuously or intermittently. In embodiments where the pressure cavity includes a pressure sac, the sac can be inflated and / or deflated while the pressure applied by the body on the pressure sac is monitored. The pressure cavity is capable of transmitting pressure waves from the body cavity, one of which is the heart beat generated by blood flowing into the cavity organs and / or surrounding tissues. The pulsating pressure from the heart beat and / or respiratory deviation can be used to determine pulmonary and cardiovascular pressures. In addition, the pressure in the pressure cavity / sac can be increased to above a threshold value (i.e., 100 mmHg) and then slowly decreased over the entire sensing range to determine the starting point of the pulse pressure, the vanishing point of the pulse pressure, and / or the relative increase / decrease in the size of the pressure pulse. The origin / disappearance or relative increase / decrease of the pressure pulsation detected by the pressure sensor can be correlated with blood pressure, perfusion pressure, mean arterial pressure, stroke volume, stroke volume variability, respiratory effort, lung pressure transmission and other pulmonary, gastrointestinal, renal or cardiovascular parameters. This process can be similar to a blood pressure cuff, where pressure is increased in the cuff above the blood pressure, and then the pressure in the cuff is slowly reduced until the blood pressure waveform (heartbeat) either appears or disappears.

[0526] Fig.102 The pressure waveform and its disappearance when the pressure bladder is inflated are shown. Note that above the mean arterial pressure, the heart beats are weakened and / or disappeared. With enough data to relate the degree of disappearance at the relative pressure point to the mean arterial pressure, the mean arterial pressure can be derived from this relative pressure waveform. The same can be done for lung pressure and other pressures that can be sensed in cavities of the body.

[0527] In some embodiments, the pressure sensor / cavity is a capsule, pouch, or reservoir that can be slowly inflated or filled when the pressure is monitored using an external transducer. In some embodiments, the pressure sensor is associated with a urinary catheter (such as a Foley catheter). Alternatively, the pressure sensor can be associated with a nasogastric tube, an orogastric tube, or a rectal tube. In yet another embodiment, the pressure sensor device and associated pressure increase device can be fully implantable. In tissue perfusion embodiments, pressure sensing can be inflated in the urethra or against the cavity surface, and pulse oximetry can be performed to detect the blanching and / or perfusion of the cavity tissue at each pressure to determine the tissue perfusion pressure.

[0528] In some embodiments, the catheter can use multiple measured parameters in a synergistic manner to improve the quality of the data analysis. In one embodiment, the catheter incorporates a sensor for capturing the ECG signal internally (such as through the urethra or bladder) or externally (such as through a sensor placed on the leg or buttocks). Using this signal, other measured parameters synchronized with the cardiac cycle (such as stroke volume) can be synchronized with the electrical signal, and noise can be removed by taking an average or median signal from many individual samples. In another embodiment, the respiratory signal is used to guide which cardiac pressure signals should be used for stroke volume variability analysis by waiting for the model waveform to appear before performing the analysis.

[0529] Fig.103 A method for synchronizing a cardiogenic signal (such as pressure fluctuations in the bladder caused by the pulse of the nearby abdominal aorta) in order to obtain a clean signal for analysis is shown. When an ECG is captured synchronously with another cardiac signal of interest, a single sample can be synchronized using, for example, the R wave of the ECG. In this figure, multiple pressure samples are captured and then aligned using the R wave of the ECG to overlay. The median signal is then calculated by taking the median of all pressure samples at the same time during the cardiac cycle. An average can also be used. In this way, random noise is filtered out because an abnormally high value due to noise in one sample will be offset by a similar abnormally low value in another sample. When more data points are added, the potential signal becomes stronger and can be used for analysis. For example, in the pressure signal shown, the peak-to-peak amplitude of the signal can be used to derive the relative stroke volume.

[0530] Fig.104The method of using respiratory pressure signal to inform cardiac pressure signal analysis to determine stroke volume variability (SVV) is illustrated. This method is particularly valuable for non-ventilated patients (i.e. patients not on ventilators). The existing techniques for measuring stroke volume (such as thermodilution or pulse contour analysis) are limited in their ability to perform the measurement of stroke volume variability (variability of stroke volume between inspiration and expiration) because they are blind to the respiratory cycle. It is advantageous to use the cavity pressure as described herein, for example, in the bladder using a Foley catheter, because it allows simultaneous capture of respiratory and cardiac signals (and slower moving intra-abdominal pressure). In this way, this current device can select which respiratory cycles are used for the analysis of stroke volume variability differently, because certain characteristics are more suitable for correct analysis (such as the speed and size of breathing). In the figure, a sample pressure signal captured from the bladder is shown. In the original pressure signal on the top, the larger fluctuation is due to breathing, and is selected for analysis, for example, based on the width, amplitude or peak value of the wave. Other characteristics not shown may also be used to define a suitable wave, including slope, area under the curve, shape, frequency, pattern or repeatability, etc. A curve amplitude filter may be used, where curves with amplitudes above a certain value are used, and curves with amplitudes below the same or another certain value are not used in the SVV calculation. The bottom graph shows the same signal after passing through a high-pass and low-pass filter. The high-pass filter leaves the basic cardiac signal (dashed line), while the low-pass filter leaves the basic respiratory signal (solid line). In this example, the difference in the intensity of the cardiac signal between the peaks and valleys of the respiratory signal (such as the peak-to-peak value) can be used to calculate the stroke volume variability.

[0531] Respiratory rate and other parameters may be sensed by a sensing Foley catheter, or may be sensed or obtained by any conventional or non-conventional means. Other parameters that may be collected include tidal volume, spirometry, respiratory flow parameters, data collected by spirometry, expiratory effort, inspiratory effort, etc. Any of these parameters may be used to help calculate stroke volume variability and / or other cardiac parameters.

[0532] The filter used to determine which pressure peaks are used in the SVV calculation can be based on any pressure curve parameter disclosed herein. In addition, the SVV calculation itself can be used to determine which pressure curve peaks are used in the calculation. For example, SVV is typically within about 10%. The system disclosed herein can include or exclude pressure curve data based on the resulting SVV calculation being within a certain range of values ​​(such as about 10%).

[0533] SVV calculations can also be patient specific. For example, a pressure curve peak filter can be based on amplitude, but the cutoff amplitude can be patient specific and based on the average, mean, or other parameter of the pressure curve for that patient. Alternatively, the filter can be based on multiple patients or multiple patients within a specific category (such as a specific disease state).

[0534] The signal and / or SVV calculation may also be filtered for patient motion and / or other artifacts such as coughing, shifting, sneezing, etc.

[0535] Additionally, a result obtained where the SVV is very low or absent may be an indication of fluid overload and appropriate treatment may be indicated.

[0536] In some embodiments of the disclosed system, the patient can be prompted to breathe in a particular manner. For example, based on the pressure curve shape (peak amplitude, frequency, etc.), the system can prompt the patient to breathe deeper, breathe slower, breathe normally, etc. The resulting respiratory pressure curve can then be factored into the SVV calculation. This type of prompting can be performed by the system when the pressure curve is insufficient to provide an SVV calculation or for any other reason.

[0537] Fig.105A and Fig.105B Two views of the base parts of the sealing mechanism between the cassette and the controller are shown. Fig.105A and Fig.105B The base part shown would normally be connected to the cassette, while Fig.106 The pin shown is connected to the controller. However, the connector can be installed in the opposite way, wherein the pin is connected to the cassette, and the base is connected to the controller. The purpose of the sealing mechanism is to connect the cavity in the cassette to the cavity in the controller when the cassette is connected to the controller, but also to block the cavity in the cassette when the cassette is disconnected from the controller. For example, when the patient is brought to the operating room or transferred from one room to another, the cassette can be temporarily disconnected from the monitor / controller. During the time when the cassette is disconnected from the controller, it may be desirable to block the cavity of the cassette so that they are not contaminated and urine, fluid or gas do not escape or enter the system.

[0538] For example, cavities such as a pressure bladder cavity (such as pressure transducer interface 1026), vent 1180, cassette pump interface 1148, and / or cassette pressure interface 1150 may have connectors such as these.

[0539] The base portion 1050 of the connector is Fig.105A and Fig.105B. The base portion can be made of a compressible, strong, inert material such as silicone or rubber. The base portion 1050 includes a base head 10504, a base rod 10508, and a base anchor 10502, and a slit 10506 having a length L3. Preferably, the slit 10506 is a single linear slit, but a sharp knife is used after the base is molded so that the slit has no rounded edges and can be completely sealed in its relatively relaxed state. When the base 1050 is connected to the cavity, fluid cannot flow through the slit of the base.

[0540] Fig.106 The pin portion 1060 shown includes a pin head 10604 and a pin shank 10602, which includes a cavity therethrough. The pin shank 10602 has an outer diameter D3. The pin 1060 fits inside the slit 10506 of the base 1050 and allows fluid to pass through the sealing mechanism when so positioned. In some embodiments, L3 is approximately the same as D3.

[0541] Fig.107A and Fig.107B Pin 1060 is shown inserted into a slot 10506 of base 1050, which allows fluid to flow through the cavity of the pin and through the sealing mechanism.

[0542] Fig.108 The base portion 1050 of the sealing mechanism on the back of the cassette is shown, which is designed to snap into an opening on the controller. The base portion of the sealing mechanism shown here is connected to the pressure bladder cavity interface 10802, the vent cavity interface 10804, the cassette pump interface 10806, and the cassette pressure interface 10808 (for measuring IAP). Note that all, some, or none of the cassette interfaces may use these types of sealing mechanisms. For example, the pressure interface 10808 for measuring IAP may not need to be sealed when the cassette is disconnected, and a different type of connector may be used.

[0543] Fig.109 How sealing mechanism works when cassette is connected to controller is shown.Cassette 1022 is shown in cross section, wherein one of sealing mechanism is installed.Base 1050 is installed on cassette part, and is sealed closed when pin 1060 does not exist.Pin 1060 is connected to controller (not shown), and when cassette 1022 is buckled in the appropriate position in controller, pin 1060 is inserted in the slit of base 1050, and this allows fluid to flow into cassette from controller and / or flow out from cassette to controller.Connection can include filter, which is shown as filter 10902 here.

[0544] Fig.110 Approximate dimensions are shown for an embodiment of base 1050. These dimensions may be different for different applications.

[0545] Fig.111 Some of the forces applied to the base 1050 when the base 1050 is integrally mounted in the cassette are shown. These forces are caused by the relationship of the diameter of the mounting hole to the diameter of the rod 10508 and the relationship of the thickness of the cassette wall to the length of the rod 10508. In addition, when the cassette is mounted in the controller, compressive forces can be pressed on the base head 10504. Whether the pin is inserted into the slit or not, these forces tend to strengthen the seal of the base 1050. In other words, based on the size and shape of the base, the slit has forces applied to it that help it stay closed either on itself or on the pin. The forces push the slit itself inward. The head 10504 is also slightly concave (like a mushroom) on the bottom, which makes it tend to expand on the bottom (the wider part) and compress on the top (where the slit opening is). This is especially true if the wall thickness of the cassette is greater than the length of the rod 10508.

[0546] In some embodiments, multiple drainage lumens may be used to prevent air lock. The proximal and / or distal openings may be staggered. The lumens may be incorporated into a single or multiple tubes and may or may not be siphon-retained. For example, 2 drainage lumens may be used, or 3 drainage lumens may be used, or 4 drainage lumens may be used, or 5 drainage lumens may be used, or 6 drainage lumens may be used, or 7 drainage lumens may be used, or 8 drainage lumens may be used, or more than 8 drainage lumens may be used.

[0547] In any of the embodiments disclosed herein, the vent can be connected to a standard or non-standard Foley catheter by connecting it to the sampling port of the Foley catheter, a barbed sampling port near the Foley catheter, or a sampling port anywhere in the drainage system. See, for example Fig.112 .

[0548] Fig.112An embodiment including an exhaust mechanism / ventilation tube is shown, which can be added to any urine drainage system including a sampling port 1004 or any other suitable port. In this embodiment, an exhaust mechanism 11200 can transform the sampling port 1004 into a vent of the system to avoid air blockage. The exhaust mechanism 11200 includes a ventilation tube 11202 and optionally includes a valve 11204 and / or a filter 11206. The exhaust mechanism can also include a needle, or a puncture mechanism or a blunt tube 11208, which punctures or opens / enters the sampling port 1004 and keeps the cavity connected to the drainage cavity 1012 fluid open to perform the exhaust function. In the figure, the sampling port is shown as a part of the barb 1016, but the sampling port can be anywhere in the drainage system. Alternatively, any other port or entry point can be used. This embodiment can be used with or without a vacuum pump. The ventilator can be rigid or flexible or bendable. The venting mechanism may include a device for suspending the vent tube above the level of the bladder (e.g., 1-10 cm above the level of the bladder). The length of the vent tube may be greater than about 1 cm. Alternatively, the length of the vent tube may be greater than about 2 cm. Alternatively, the length of the vent tube may be greater than about 3 cm. Alternatively, the length of the vent tube may be greater than about 4 cm. Alternatively, the length of the vent tube may be greater than about 5 cm. Alternatively, the length of the vent tube may be greater than about 10 cm. The ID of the vent tube may be less than about 5 mm. Alternatively, the ID of the vent tube may be less than about 4 mm. Alternatively, the ID of the vent tube may be less than about 3 mm. Alternatively, the ID of the vent tube may be less than about 2 mm. Alternatively, the ID of the vent tube may be less than about 1 mm.

[0549] In this figure, the vent tube 11202 is shown as terminating in the atmosphere, but the vent tube can be connected to Fig.11E Drainage bag as shown. If a valve and vent are present, the valve can be between the sampling port and the vent, or the vent can be between the sampling port and the valve. This type of venting mechanism can be implemented in the sampling port after an initial volume of urine has been drained from the bladder. This type of venting mechanism can be incorporated into a band or patch that is intended to be secured to the patient's leg or elsewhere with barbs. The venting mechanism / vent tube of this embodiment can have one or more small diameter sections having a diameter such as Fig.11D Length shown. For example, the portion of the vent tube 11202 can be relatively long and have a relatively small diameter to prevent urine from traveling within the vent tube and reaching the valve and / or filter.

[0550] Rather than using the puncture mechanism 11208 in conjunction with the sampling port 1004, the puncture mechanism can be used along the tube of the catheter or drainage tube. Alternatively, a mechanism can be used where the port is normally closed, but accepts an additional venting mechanism / vent tube. For example, a sealing mechanism-pin configuration can be used, such as Figures 105A-111 The sealing mechanism-pin configuration shown, where the base is on the catheter / drain and the pin is part of the venting mechanism / vent, or vice versa. In some embodiments, the port 1004 can be on an additional barb or connector part that is meant to be placed between the catheter and the drain.

[0551] Any of the vent tube embodiments disclosed herein may additionally or alternatively be used to ventilate a drainage bag or cassette. For example, Fig. 10A The bag vent 1142 shown may incorporate any vent tube design. Or for example, Fig.11A The vent 1180 shown may incorporate any vent tube design.

[0552] Fig.113 An embodiment including a pump / pusher 11302 is shown. The pump preferably acts on the outside of the drainage tube 1012 and pushes the fluid in the drainage tube toward the drainage bag when doing so. The pump can be a peristaltic pump, a pump with rollers, a pump that applies periodic pressure, etc. In an embodiment where the pump is very simple and applies periodic pressure (as schematically shown here), the ID of the drainage tube can change along its length to cause the fluid to flow mainly in one direction (in this case toward the drainage bag). The ID on the patient side of the drainage tube can be less than the ID on the drainage bag side of the drainage tube. The ID can be gradually reduced, as shown in the enlarged view here, or the ID change can be gradual.

[0553] Fig.114 An embodiment is shown in which the drain tube 1012 includes a coiled or compressed segment 11402. In this embodiment, slack in the drain tube is reduced. The coiling can be supported by a shape memory material or by a physical clip or some kind of retainer. Preferably, the drain tube can be extended to accommodate patient movement.

[0554] Fig.115A and Fig.115B An embodiment of a barb including a tube seating mechanism is shown. The barb 11502 includes a urine drainage tube 11504 surrounding a urine drainage cavity 11506 and a vent tube 11508 surrounding a vent cavity 11510. The tubes 11504 and 11506 are inserted into the barb during manufacturing and seated against the step 11512. Fig.115B As shown, this allows both the urine drainage lumen and the vent lumen to open into a single lumen 11516 of the catheter manifold 11514.

[0555] In some embodiments, the controller controls a pressure sensor at or near the barb to determine when the pressure in the barb area is not overly negative so that a vacuum can be drawn on the drainage tube without causing suction damage to the bladder. The pressure sensor can also be used to determine the initial system position to ensure that the pressure in the drainage line is not positive or too negative. If the pressure in the drainage tube is too negative, the controller can operate a valve in the urine collection reservoir or elsewhere to temporarily stop or slow the discharge of urine to allow the pressure to become less negative, reducing the possibility of suction damage to the bladder.

[0556] In some embodiments, the bladder is periodically pressurized to help drain urine from the bladder. This can be done using a retaining bladder, a pressure sensing bladder, another bladder, or other means.

[0557] In some embodiments, air lock clearance is performed intermittently. In some embodiments, air lock clearance is performed continuously, for example by pulling a continuous slight vacuum on the drainage tube.

[0558] In some embodiments, pulse oximetry data may be collected from the patient's skin (eg, from the thigh or groin or elsewhere in the leg area).

[0559] In some embodiments, the controller manages the amount of air and / or pressure in the entire system. For example, the controller can sense when the urine collection bag is over-pressurized, which may occur if the air filter (shown as 1142 in several figures) is blocked or wet. This increases the risk that the bag may rupture. If this occurs, the controller can instruct the system to do one or more things to alleviate the problem. The controller can try to clean the filter by blowing "a few" air across the filter. The controller can slow down or stop the urine discharge by slowing down or stopping the air plug removal pump. The controller can instruct the pump to reverse its direction intermittently, reducing the pressure in the drainage bag. The controller can warn the user to replace or otherwise manually repair the drainage bag problem. The controller can monitor the pressure anywhere in the system to identify and possibly alleviate pressure-related problems. The controller can monitor the pressure at the barb, in the drainage line, in the ventilation line, in the reservoir / cassette, in the drainage bag, etc. For example, the controller can control the pressure in the cassette to help the cassette empty, filter removal, bubble reduction, etc.

[0560] In some embodiments, acute kidney injury (AKI) or other conditions can be detected or possibly predicted and / or prevented at an early stage. For example, AKI is currently classified using the RIFLE (risk, injury, failure, loss of renal function, and end-stage renal disease) criteria. The RIFLE criteria include the following classifications:

[0561] category Urine output risk <0.5mL / kg / h x 6h damage <0.5mL / kg / h x 12h Exhaustion <0.3 mL / kg / h x 24 hours or anuria x 12 hours

[0562] Because the embodiment of the sensing Foley catheter system disclosed herein can measure urine output and intra-abdominal pressure and other parameters in real time and frequently or continuously, the health parameters of the patient can be evaluated over time within this range. For example, urine output can be measured continuously, and capture and store and analyze data over time. The patient's weight and other patient-related data can be input into the system. As a result, UO / kg / h can be easily captured, calculated, tracked and analyzed over time. Based on the RIFLE standard, the alarm can be programmed to occur when or before AKI risk, injury and failure. The patient's weight and / or other patient data can be received by the system controller through manual user input, integration with other hardware (such as scales), integration with electronic health or medical records, wireless transmission or other means.

[0563] Additionally, the sensing Foley catheter system could use different algorithms, or improve existing algorithms, to predict or identify patient conditions. For example, by taking into account urine output data that is available earlier, the system might be able to predict the risk of kidney damage or failure earlier than the RIFLE criteria.

[0564] As an example, see Fig.116A -E. Fig.116A Shown is a graph of urine output versus time in increments of one hour. Shown on the urine output scale is a line representing 0.5 mL / kg / h. According to the RIFLE standard, if urine output is below this amount during 6 consecutive hours, there is a risk of renal injury. The last 6 urine output readings (12-17 hours) represent conditions that will be marked as an increased risk of renal injury according to the RIFLE standard. The sensing Foley catheter system is able to go beyond these data and add more information to the patient's condition. For example, considering the urine output during the 9th, 10th and 11th hours, we can see that urine output declines in each of these hours. This decline in urine output below 0.5 mL / kg / h, followed by 3 hours, has been shown to predict another 3 hours of urine output below 0.5 mL / kg / h. In other words, decreased urine output (even above 0.5 mL / kg / h) followed by 3 hours of urine output below 0.5 mL / kg / h is an earlier predictor of risk of renal injury than the RIFLE criteria. The Sensing Foley system can predict AKI risk 3 hours earlier than the current RIFLE criteria.

[0565] Figures 116B-116E Additional examples of possible methods to predict risk of renal injury earlier than the RIFLE criteria are shown. Fig.116BAn algorithm is shown that uses a trend in the data of decreasing urine output over several hours preceding a 3-hour urine output of less than 0.5 mL / kg / h to predict the risk of renal injury. Fig.116C An algorithm is shown that predicts the risk of rena...

Claims

1. A system for assessing the health of a patient, comprising: a drainage tube configured to be in fluid communication with at least one opening located near or at the distal end of the catheter; a pump in fluid communication with the drainage tube and configured to apply negative pressure to the drainage tube; a valve configured for one-way flow and in fluid communication with the drainage tube; as well as a controller in communication with the pump, wherein the controller is configured to activate the pump to apply the negative pressure for clearing the air lock from the drainage tube, wherein the controller is configured to monitor urine output from the patient for a first predetermined time period above a urine output threshold and for a second predetermined time period below the urine output threshold, and The controller is further configured to determine a risk of acute kidney injury (AKI) if the urine output is below the urine output threshold for more than the second predetermined period of time.

2. The system of claim 1, wherein the pump is configured to be activated periodically.

3. The system of claim 1, further comprising a collection reservoir in fluid communication with the drainage tube for receiving urine output from the patient.

4. The system of claim 3, wherein the controller is configured to determine urine output within the collection reservoir.

5. The system of claim 3, wherein the collection reservoir is configured to be emptied when a predetermined volume within the collection reservoir is reached.

6. The system of claim 1, wherein the urine output is collected in at least hourly increments.

7. The system of claim 1, wherein the urine output threshold comprises 0.5 mL / kg / hour.

8. The system of claim 1, wherein the first predetermined period of time is at least 3 hours.

9. The system of claim 8, wherein the second predetermined period of time is 3 hours or less.

10. The system of claim 1, wherein the second predetermined period of time is at least 1 hour.

11. The system of claim 1, wherein the controller is further configured to activate the pump to apply the negative pressure at a first level for clearing an air lock from the drainage tube, and thereafter apply the negative pressure at a second level.

12. The system of claim 11, wherein the negative pressure is applied at the second level immediately after the air lock is cleared from the drainage tube.

13. The system of claim 11, wherein the negative pressure is applied at the second level for a predetermined period of time after the air lock is cleared from the drainage tube.

14. The system of claim 1, wherein the controller is further configured to determine a risk of AKI based on the urine output and weight of the patient.

15. The system of claim 1, wherein the controller is further configured to determine the risk of AKI based on the urine output and intra-abdominal pressure of the patient.

16. The system of claim 1, wherein the controller is further configured to determine the risk of AKI based on the urine output and respiratory rate of the patient.

17. The system of claim 1, wherein the controller is further configured to determine the risk of AKI based on the urine output and heart rate of the patient.

18. The system of claim 17, wherein the controller is further configured to determine the risk of AKI based on the urine output and intra-abdominal pressure and temperature of the patient.

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