Systems, devices, and methods for bodily fluid drainage and analysis and for assessing health status

Abstract

Systems, devices, and methods for draining and analyzing bodily fluids to assess health are generally described that include a pump mechanism having a first end fluidly connectable to a portion of a drainage line, and a vent mechanism having a one-way valve and having a first end fluidly connectable to the drainage catheter and the drainage line. The pump mechanism may be configured to create a negative pressure in the drainage line when the pump mechanism is in communication with the drainage line, and the one-way valve may be configured to open to the environment when the vent mechanism is connected at the first end and the drainage line is at a pressure lower than ambient pressure to prevent an airlock from occurring in the drainage line.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application is related to International Patent Application PCT / US2018 / 13399 filed on January 11, 2018, PCT / US2011 / 043570 filed on July 11, 2011, PCT / US2012 / 028071 filed on March 7, 2012, PCT / US2016 / 060365 filed on November 3, 2016, PCT / US2015 / 052716 filed on September 28, 2015, PCT / US2014 / 044565 filed on June 27, 2014, PCT / US2015 / 010530 filed on January 7, 2015, PCT / US2016 / 060365 filed on November 3, 2016, 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, U.S. Provisional Application No. 62 / 776,388 filed on December 6, 2018, U.S. Provisional Application No. 62 / 798,365 filed on January 29, 2019, each of which is hereby incorporated by reference into this specification to the same extent as if such individual publications or patent applications were specifically and individually set forth as being incorporated by reference.

[0002] The present invention relates to the field of medical devices. In particular, the present invention relates to devices for assisting in emptying the bladder, measuring various urine parameters such as urine volume, and partial pressure of oxygen, urine conductivity, and urine specific gravity, monitoring kidney function, analyzing urine parameters such as urine contents including the presence or absence of infection, tracking and / or controlling fluid administration. The present invention further relates to a medical device capable of detecting physiological data based on sensors incorporated into a catheter configured to remain in any of the urinary tract, gastrointestinal tract, rectal position, preperitoneal cavity, pleural cavity, or other body cavities. Incorporation by Reference

[0003] All published patent applications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual published patent application or patent application was specifically and individually indicated to be incorporated by reference.

Background Art

[0004] It is said that 10% of patients during hospitalization and long-term convalescence have indwelling urethral catheters. Urine tests are performed almost invariably on critically ill patients, and monitoring urine output every hour in the ICU has become a daily routine. The amount of urine produced is an indicator of the state of body fluids and kidney function. However, this important indicator can be mismeasured due to numerous error factors.

[0005] The device most commonly used for bladder drainage is the Foley catheter. A flexible tube with an anchor balloon and small holes, designed to drain urine from a central lumen, has remained almost unchanged since its release. However, it has been found that in the current design of the Foley catheter, the residual volume remaining in the bladder is large, for example, exceeding 50 mL in the supine position. See Non-Patent Document 1. In one study, the average residual volume was 96 mL in the ICU and 136 mL in the general ward. See Non-Patent Document 2. Also, a large amount of residual urine is often seen in the drain tube connecting the Foley catheter to the drainage bag and other parts within the drainage system.

[0006] The residual urine in the bladder and drain tube is because large air bubbles (air locks) formed in the tube prevent the flow of urine from the bladder to the drainage bag. Therefore, it has become routine for nurses to operate the drainage tube before measuring urine output to assist in emptying the tube. In the ICU where measurements are taken once an hour, this is a very repetitive and inaccurate task. There is a need for more accurate and automated urine output measurement.

[0007] In addition, within the urine collection system, there is also an opportunity to measure and analyze urine parameters.

[0008] In addition to improving urine volume measurement and urine parameter analysis, the urinary drainage catheter itself provides an untapped opportunity for the detection, collection, and analysis of additional patient parameters.

Prior Art Documents

Non-Patent Documents

[0009]

Non-Patent Document 1

Non-Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0010] In addition, there are many types of medical devices configured to control the treatment and / or maintenance of patients. For example, a respirator can control a patient's respiratory rate, tidal volume, and / or mixed gas. Intravenous (IV) administration can administer substances such as fluids and / or drugs to a patient. Additionally, devices capable of operations such as drug delivery are also included. This type of medical device can be precisely controlled by various settings and the like. Medical staff such as nurses can check various parameters of a patient and adjust the settings of the medical treatment device accordingly. There is a need for a control unit that automatically or semi-automatically controls the settings of the medical treatment device using the patient's parameters.

Means for Solving the Problems

[0011] A Foley-type catheter that is widely popular, low-cost, and easily installable by medical staff can be modified and / or have functions added to be used as a means for obtaining important diagnostic information. The technology disclosed herein can provide high-resolution and previously unobtainable diagnostic information, such as that obtained from a Foley catheter with an intra-abdominal pressure (and others) sensing function.

[0012] In addition, it has been found that the occurrence of an air lock greatly distorts the measured value of intra-abdominal pressure. Also, when the bladder is not empty, it may adversely affect the measured value of the pressure inside the bladder. Further, the technology disclosed herein detects and removes an air lock in settings such as intra-abdominal pressure measurement and realizes more complete bladder drainage.

[0013] The technology disclosed herein aims to more effectively drain the bladder, prevent the occurrence of an air lock in the drainage tube, eliminate it if it occurs, and improve the accuracy of automatically measuring urine volume. Also, the disclosed technology attempts to incorporate additional measurements of urine such as oxygen partial pressure, conductance, and specific gravity, gas pressure, turbidity, infection, sediment, etc. to improve the monitoring of the state of fluids, renal function, and other important patient parameters.

[0014] Further, the disclosed technology relates to a Foley catheter that detects physiological data collected from at least one of a patient's bladder and urinary tract by, in particular, high-fidelity pressure sensing and conversion into a signal suitable for processing. In some embodiments, a pressure-sensing Foley-type catheter may further be capable of detecting temperature and clinically significant analytes. Examples of physiological parameters that a Foley catheter system for detection can measure (temporal measurements and trends in values over time) include urine volume, respiratory rate, heart rate, heart rate variability, cardiac output, cardiac output variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas content, pulse transit time, pulmonary blood volume variability, body temperature, blood components, and other patient parameters.

[0015] A drainage assembly according to one embodiment configured to prevent the accumulation of negative pressure may generally be composed of an elongate catheter having a first end configured to be inserted into a body cavity. The catheter may include at least one opening near or at the first end in fluid communication with a catheter lumen formed therein, a drainage lumen in fluid communication with the second end of the catheter, a reservoir in fluid communication with the drainage lumen, and a ventilation mechanism in fluid communication with the drainage lumen and a positive pressure lumen. A valve may be disposed within the ventilation mechanism and configured to maintain a closed position until a first pressure level within the drainage lumen drops to a second pressure level and the valve moves to an open position. Further, a vent may be disposed in fluid communication with the valve, and the ventilation mechanism may be configured to suppress wetting of the vent from the fluid within the drainage lumen; also, a control unit in communication with the reservoir is provided, and the control unit is configured to measure the amount of fluid collected within the reservoir.

[0016] In another example, the drainage assembly may be configured to prevent the accumulation of negative pressure and generally includes an elongate catheter having a first end configured to be inserted into a body cavity. The catheter has at least one opening in or near the first end that is in fluid communication with a catheter lumen formed therein. The drainage lumen may be in fluid communication with a second end of the catheter and includes a positive pressure lumen in fluid communication with the drainage lumen, a reservoir in fluid communication with the drainage lumen, and a ventilation mechanism coupled to the drainage lumen. The ventilation mechanism is configured to suppress wetting of the vent from the fluid in the drainage lumen. The control unit may be in communication with the reservoir and is configured to measure the amount of fluid collected in the reservoir and may also include a valve configurable between a closed position and an open position. The valve moves from the closed position to the open position when a first pressure level applied to the valve drops to a second pressure level.

[0017] Specific patient parameters that can be measured and / or determined by the disclosed technology are affected by and / or affect the treatment of the patient by a medical treatment device. For example, patient parameters such as urine output, respiratory rate, heart rate, cardiac output, cardiac output variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas content, body temperature, blood components, etc. can be affected by and / or affect medical treatment. Examples of medical acts controlled by a medical device include respiratory rate and respiratory components controlled by a respirator, intravenous drip rate and drip components controlled by an intravenous drip control unit, drug delivery controlled by a drug delivery device or an intravenous drip control unit, urine output controlled by a urine pump, intraperitoneal fluid volume controlled by a drain pump, and other treatments controlled by other medical treatment devices.

[0018] A system according to one embodiment for analyzing body fluids generally includes an elongate catheter having an inflatable balloon disposed in the vicinity of or at the distal end of the catheter and further forming one or more openings proximate the balloon, a ventilation mechanism coupled to the proximal end of the catheter and configured to pass air therethrough when a negative pressure is applied to the ventilation mechanism, a first lumen coupled to the ventilation mechanism and in fluid communication with the one or more openings, a second lumen in fluid communication with the balloon, a reservoir coupled to the proximal end of the first lumen and in fluid communication with the one or more openings, and a control unit configured to connect to the reservoir and programmed to control the pressure within the first lumen. The control unit is further programmed to monitor the amount of urine received in the reservoir from the patient and measure the patient's intra-abdominal pressure based in part on pressure changes within the balloon. The control unit is further configured to store patient data.

[0019] In one exemplary method for analyzing one or more body parameters from a patient, the method generally includes positioning an elongate catheter having an inflatable balloon positioned in the vicinity of or at the distal end of the catheter within a body cavity at least partially filled with body fluid, receiving urine through one or more openings formed along the catheter proximate the balloon, further receiving body fluid within a reservoir located external to the body cavity and in fluid communication with the one or more openings through the body cavity, venting air through a ventilation mechanism in communication with a fluid lumen when a negative pressure is applied to the fluid lumen, analyzing the amount of urine received in the reservoir through a control unit programmed to control the negative pressure to the ventilation mechanism, measuring the patient's intra-abdominal pressure based in part on pressure changes within the balloon, and storing one or more parameters of patient data through the control unit.

[0020] Some embodiments of a Foley catheter system for detection include a loop control unit that receives one or more data related to patient parameters and uses this information to control one or more medical treatment devices. The loop control unit may be provided integrally with either a device that measures the patient's parameters, a medical treatment device, or both.

[0021] A pressure measurement balloon on a catheter as disclosed in International Patent Application No. PCT / US2014 / 044565 (Patent Document 1) (which is incorporated herein by reference in its entirety), whose invention name is a Foley catheter for detection, is an example of a device that measures patient parameters. Additional embodiments are disclosed herein. The Foley catheter system for detection can include a pressure measurement balloon and / or other sensors, and the ability to measure urine volume and components to measure urine flow rate, IAP, respiratory rate, heart rate, cardiac output, tissue oxygenation, urine composition, body temperature, and other patient parameters.

[0022] In addition, there are parameters measurable with a Foley-type catheter, such as urine specific gravity and pulse pressure variation. These parameters can be used to assist in controlling medical treatment devices such as ventilators and / or infusion and / or fluid replacement devices.

[0023] Urine specific gravity is an indicator that shows the number and weight of solute particles in urine. The normal range is about 1.010 to 1.030. A measurement value higher than this may indicate symptoms such as dehydration. A measurement value lower than this may indicate symptoms such as fluid overload. Measurement may be performed with a sensor of the Foley catheter for detection. The measurement result may indicate increasing (in case of dehydration) or decreasing (in case of fluid overload) the patient's infusion rate. The measurement result may also indicate changes such as ventilation parameters and drug injection.

[0024] Fluctuations in pulse pressure can predict the reactivity of body fluids to medical treatment devices such as at least one of a ventilator and an infusion device. The detection Foley catheter records the pressure waveform, and the control unit can identify the maximum pressure pulse and the minimum pressure pulse that coincide with the respiratory cycle. The control unit can calculate the fluctuations in pulse pressure. The fluctuations in pulse pressure can assist in determining whether a patient will respond to infusion therapy. The fluctuations in pulse pressure can also be used by the control unit to control the treatment in a feedback loop. When the fluctuations in pulse pressure are large, the patient requires more fluid. When the fluctuations in pulse pressure are small, a smaller fluid volume suffices.

[0025] The detection Foley catheter system can measure cardiac activity by detecting the pressure in the bladder. The detection Foley catheter can measure not only cardiac activity but also respiratory activity. Since the frequencies of the patient's respiratory rate and heart rate may be close to each other, measuring the patient's respiratory rate may distort the measurement of the heart rate. To overcome this problem, in some embodiments of the control unit, the respirator is temporarily stopped at the end of one or more inspiration points and / or the respirator is temporarily stopped at the end of one or more expiration points (only a few seconds each time, for example 1 to 3 seconds, or for example 1 to 4 seconds) so that the cardiac waveform can be captured without respiratory distortion. By capturing the detailed electrocardiogram waveform in this way, the control unit can measure the stroke volume variation (SVV) useful for the detection of sepsis and the prevention of fluid overload. As an alternative embodiment, the patient may be required to stop breathing at at least one of the inspiration point and the expiration point.

[0026] In another example, a catheter system may generally comprise a catheter having at least one opening near or at the 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 may be arranged in line with the vent tube and located proximal to the barb, and the control unit may communicate with the one-way valve and is programmed to apply a negative pressure to the drainage tube such that the one-way valve opens and fluid passes through the vent tube.

[0027] In another example, one method for discharging fluid may generally include positioning a catheter system in proximity to a subject's body, the catheter system having a catheter with at least one opening near or at the distal end of the catheter, a barb in fluid communication with the proximal end of the catheter, and a drainage tube in fluid communication with the at least one opening. A control unit in communication with a one-way valve may operate with the one-way valve arranged in line with the vent tube and in fluid communication with the barb, and the one-way valve is further located at a location proximal to the barb. Applying a negative pressure to the drainage tube may cause the one-way valve to open and fluid to pass through the vent tube.

[0028] In another example, a system for evaluating a patient's health generally includes a drainage tube configured to be in fluid communication with at least one opening disposed near or at the 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 one-way flow and in fluid communication with the drainage tube. The control unit may communicate with the pump and is configured to operate the pump to apply a negative pressure to remove an air lock from the drainage tube. The control unit may be configured to monitor the urine output from the patient over a first predetermined period exceeding a urine volume threshold and a second predetermined period below the urine volume threshold, and the control unit may be further configured to determine the risk of acute kidney injury (AKI) if the urine volume below the urine volume threshold exceeds the second predetermined period.

[0029] In another example, a method for evaluating a patient's health generally includes receiving urine output from the patient via a catheter having at least one opening near or at the distal end of the catheter, applying a negative pressure to a drainage tube in fluid communication with the at least one opening until an air lock is removed from the drainage tube, monitoring the urine volume via a control unit over a first predetermined period exceeding a urine volume threshold and further monitoring the urine volume over a second predetermined period below the urine volume threshold. Further, the method may include determining the risk of AKI if the urine volume below the urine volume threshold exceeds the second predetermined period.

[0030] A fluid drainage system according to one aspect may generally include a pump mechanism having a first end fluidly connectable to a portion of a drainage line, and a ventilation mechanism having a one-way valve and having a first end fluidly connectable to a drainage catheter and the drainage line. The pump mechanism may be configured to create a negative pressure within the drainage line when the pump mechanism is in communication with the drainage line, and the one-way valve may be configured to open to the environment when the ventilation mechanism is connected at the first end and the drainage line is at a pressure lower than ambient pressure to prevent an air lock from occurring within the drainage line.

[0031] One aspect of a method for draining body fluid from a subject may generally include providing a pump mechanism connectable to a portion of a drainage line, providing a ventilation mechanism fluidly connectable to a drainage catheter and the drainage line, and forming a negative pressure within the drainage line via the pump mechanism. The body fluid is received into the drainage line through the drainage catheter, and the one-way valve may be fluidly coupled to the drainage line and proximate to the drainage catheter such that air from the environment is introduced through the one-way valve when the drainage line is at a pressure lower than ambient pressure. Thus, formation of an air lock within the drainage line can be suppressed.

[0032] The drawings illustrate novel features of the invention. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description which illustrates exemplary embodiments in which the principles of the invention are utilized, and to its accompanying drawings.

Brief Description of the Drawings

[0033]

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DETAILED DESCRIPTION OF THE INVENTION

[0034] Hereinafter, preferred embodiments of the present invention will be described in detail. However, alternative embodiments of various elements of the present device are also possible. Examples of these embodiments are shown below, but the scope of the present invention is not limited to these specific configurations.

[0035] Detection Foley Catheter

[0036] Figure 1 is a diagram showing a detection Foley catheter and some of its elements according to one embodiment. The catheter can be understood to have various parts according to its arrangement when inserted into a human subject, such as a proximal part remaining outside the subject, a central or urethral part staying in the urethra, and a distal or bladder part staying in the bladder.

[0037] For example, various internal lumens such as the air or fluid lumen that communicates with the balloon 104 for bladder retention and the retention balloon port 118 traverse the length of the catheter 102. The urine drainage lumen has one or more distal openings 106 present in the bladder portion of the catheter and an opening at the proximal end 114 of the catheter. The urine drainage lumen may be connected to a urine drainage tube that carries urine to a collection container. The urine drainage tube may be separate from or integral with the sensing Foley catheter. In some embodiments, the bladder drainage lumen and the distal opening may also function as an infusion conduit into which a drug can be infused, or into which a heated or cooled fluid can be infused. One or more analyte sensors (not shown) or one or more temperature sensors (not shown) may be disposed on the catheter, i.e., either on the urethral portion or the bladder indwelling portion of the catheter. Electrical or optical fiber leads may be disposed within a lumen that enables communication of sensing signals between the distally disposed sensor and the proximal portion of the catheter and further enables communication with a data processing device or control unit.

[0038] The inflatable pressure sensing balloon 108 (or a pressure sensing membrane disposed across an opening) may be disposed at or near the distal end of the catheter. Embodiments of the pressure sensing balloon or pressure sensing membrane may be understood to include a pressure interface having a distal surface exposed to the pressure within the bladder and a proximal surface exposed to a proximal fluid column. The pressure sensing balloon or membrane is in fluid communication with a fluid column or lumen that 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 either a liquid or a gas fluid) may be composed of a dedicated lumen or a shared lumen.

[0039] In some embodiments, a temperature sensor can be provided 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, a connector, and / or a control unit.

[0040] Although the proximal end of the catheter consisting of a plurality of individual ports is shown in FIG. 1, some or all of the ports may be integrated into a single port, or may be integrated into the urine drainage line that moves to the urine drainage system and / or the control unit. There may also be at least one of the other lumens and ports.

[0041] The pressure-based physiological parameters that the Foley catheter system for detection can detect and / or measure via the control unit based on the detected parameters can include, as an example, intraperitoneal pressure, respiratory rate, and heart rate, relative pulmonary ventilation volume, cardiac output, relative cardiac output, and absolute cardiac output. Some embodiments of the Foley catheter may further include a temperature sensor, one or more analyte sensors, electrodes, and either a paired light source and sensor. In embodiments further provided in this way, it is also possible to provide other forms of physiological data, such as, for example, blood pressure, oxygen saturation, pulse oximetry, electrocardiogram, capillary filling pressure, and the like.

[0042] Embodiments of the Foley catheter for detection can detect any one or more of a plurality of clinically relevant parameters, such as those included in the following examples, namely, urine pH, urine uric acid content, urine nitrate content, respiratory rate, heart rate, perfusion pressure of the bladder wall or urethral wall, temperature within the bladder or urethra, electrocardiogram via a sensor on the bladder wall or urethra, respiratory volume, respiratory pressure, intraperitoneal pressure, urine glucose, blood glucose via the urethral mucosa and / or bladder mucosa, urine protein, hemoglobin in urine, blood pressure, and the like. In some embodiments, the catheter can detect a plurality of parameters, but in some embodiments, it may be limited to a small number, such as a single parameter for a focused application (e.g., respiratory rate in a patient with dyspnea).

[0043] The technology of the present disclosure can acquire a high-resolution time-series profile of the peritoneal pressure in the bladder (pressure as a function of time) and perform conversion processing into individual pressure profiles that can be assigned to specific physiological sources such as peritoneal pressure, respiratory rate, and heart rate. As provided by this technology, by tracking the pressure profile at a sufficiently fast sampling rate, the pressure profile can further be decomposed and / or analyzed into relative pulmonary ventilation volume, cardiac output, relative cardiac output, and absolute cardiac output.

[0044] Accordingly, aspects of the disclosed technology relate to the fidelity and resolution of a pressure signal generated in response to changes in the pressure within the bladder, such changes reflecting the pressure profile within the peritoneal cavity, and such pressure profile including the cumulative input from the physiological sources described above. Aspects of the technology further relate to the fidelity and resolution of the conversion from the pressure signal to a high-resolution electrical signal. Aspects of the technology further relate to processing an entire electrical signal profile that serves as a surrogate for the pressure profile within the peritoneal cavity into component profiles that can be assigned to physiological sources.

[0045] The sensitivity of the inflated balloon as a pressure sensor is a function of the differential pressure across the balloon membrane, which is in part a baseline condition. The balloon is most sensitive to pressure when the baseline differential pressure is close to zero. As the baseline differential pressure increases, the sensitivity of the pressure-sensing balloon decreases. Therefore, the technology according to the present disclosure provides an automatic priming method for maintaining the balloon in an inflated state with a minimum differential pressure.

[0046] To effectively capture a physiological pressure profile, it is necessary to sample the profile at a rate sufficient to resolve the frequency of the changes inherent in the profile. This is a consideration based on the Nyquist-Shannon sampling theorem, which states that to resolve an event operating at a frequency of B cycles per second, a sampling frequency of at least 2B samples per second is required. Applying this to a physiological pressure cycle, for example, when the heart rate is 70 beats per minute, a sampling rate of at least 140 samples per minute is required to effectively capture the cycle. This relationship underlies aspects of the disclosed technology that define the sampling rates particularly required to capture physiological pressure cycles such as relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac output.

[0047] Embodiments of the technology include a pressure interface that can be represented by a balloon having either a compliant or non-compliant membrane.

[0048] According to an embodiment of the present technology, the balloon for expansion pressure detection can assume one or more of at least two basic forms: compliant or non-compliant. As exemplified by a conventional party balloon, in the compliant balloon type, the pressure detection balloon is formed of or includes a compliant membrane. Thus, the surface area of the membrane expands or contracts as a function of the expansion of the balloon. Due to the compliance of the membrane, various characteristics of the entire balloon are determined according to the degree of expansion. When inflated, the balloon maintains a substantially constant or preferred shape as determined by the mandrel on which the balloon is formed if not constrained. When the balloon expands from its minimum volume to its maximum volume, the membrane of the balloon maintains tension. Within the range allowed by the compliance of the compliant membrane, as the pressure during inflation increases, the volume expands as a result. The balloon can be considered partially compliant as a whole in that its shape accommodates the spatial constraints that may be encountered during expansion or inflation, but the balloon has a preferred or original shape, and such shape preference prevents the level of shape compliance or conformity shown by non-compliant balloons.

[0049] In a non-compliant balloon, an expandable pressure-sensing balloon is formed of, or includes, a non-compliant membrane, or a substantially non-compliant membrane. As such, the surface area of the membrane does not expand or contract in response to the degree of inflation or pressurization of the balloon. A non-compliant pressure-sensing balloon can generally be exemplified by a conventional Mylar® balloon. Due to the lack of compliance of the membrane, various characteristics of the entire balloon are determined according to the degree of inflation. When the balloon is expanded from its minimum volume to near its maximum volume, the membrane of the balloon becomes compliant and assumes a relaxed state. The inflation of a non-compliant balloon occurs due to the outward orientation of wrinkles and folds in the membrane. The contraction or compression of a non-compliant balloon generally occurs by inwardly oriented wrinkles or folds. When a non-compliant balloon is fully inflated (or substantially inflated) without being placed in a confined space, it assumes a preferred or natural shape determined by the shape of the membrane or fabric of the balloon. However, in a partially inflated state, the entire balloon is very compliant and deformable and can assume the required shape within a closed space.

[0050] An inflatable pressure-sensing balloon according to an embodiment of the present technology can also include the characteristics of both of two basic forms, compliant and non-compliant. In these embodiments, the membrane may include a compliant region and a non-compliant region. This hybrid type of balloon operates as a whole in a form that draws out the behavioral aspects of both compliant and non-compliant balloons as described above. Further, a compliant balloon may be formed of a membrane with a non-uniform composition or thickness. In such an embodiment, regions with different thicknesses or compositions may have different degrees of compliance, which may affect the behavior of these regions during the inflation of the balloon. In yet another embodiment, the compliance of the membrane can have a bias or polarity that tends to allow compliance in one or more directions but tends not to allow compliance in one or more other directions.

[0051] Embodiments of the sensing Foley catheter include devices that utilize very small pressure lumens for air transmission. Pressure measurements have been made at inner lumen diameters of 3 mm, 1 mm, and 0.5 mm. Even when the air lumen diameter was reduced from 3 mm to 1 mm and 0.5 mm, little signal degradation was observed.

[0052] These data indicate that it is appropriate to use the pressure transmission system according to this embodiment when the diameter of the pediatric catheter is as small as 4F. Also in this embodiment, by making the tip of the catheter have a lower profile than other parts of the catheter, even if a pressure sensing balloon is added, a small diameter can always be maintained. Therefore, the catheter of the present invention is uniquely suitable for pediatric applications where a more appropriate and minimally invasive monitoring method is urgently needed. In another example, in order to minimize the number of necessary lumens, the holding balloon itself can be used as a pressure balloon. In one embodiment, the holding balloon is used in a fully inflated state and is only used to track the macro trend of IAP. In another example, in order to increase the sensitivity of the balloon to small changes in pressure, the holding balloon is only slightly inflated. According to this embodiment, it is possible to more finely measure minute parameters such as heart rate, relative stroke volume, relative cardiac output, respiratory rate, relative tidal volume, etc. Also, by making the pressure lumen smaller, space can be secured to incorporate other technologies such as sensors into a thicker catheter.

[0053] In an embodiment of a sensing Foley catheter in which a retention balloon is used as a pressure balloon, the pressure measured within the retention balloon is offset by the pressure necessary only to inflate the balloon sufficiently large to function as a retention balloon. As a result, it is necessary to subtract the inflation pressure and, in some cases, the pressure resulting from the retention balloon being in contact with the inner surface of the bladder from the pressure measurement value. In this way, smaller pressure changes can be tracked in the same manner as when measured with an individual pressure balloon. The offset of the inflation pressure is determined by measuring the pressure within the retention balloon when the retention balloon is first inserted into the patient, or by measuring the inflation pressure of the retention balloon outside the patient's body, or by other means. The retention balloon can be filled with a fluid, air, or other suitable gas.

[0054] Embodiments of the disclosed technology can include embodiments in which the pressure sensor is a mechanical pressure sensor, such as one using optical fibers, strain gauges, magnetism, resonance, and / or other suitable technologies.

[0055] Figure 2 shows an example of respiration rate detection data from a human subject provided by a sensing Foley catheter system according to one embodiment. During this test period, the subject performs the following respiration sequence: (1) apnea at the end of exhalation, (2) Valsalva, (3) hyperventilation, (4) Valsalva, (5) apnea at the end of exhalation.

[0056] Figure 3 shows a detailed portion of a normal respiration period in a respiration profile similar to that shown in Figure 2. Since the peak of respiration is clearly shown in the pressure curve, the respiration rate can be determined, and since the peak of the heartbeat is shown, the heart rate can be determined.

[0057] FIG. 4 is a diagram showing an example of heart rate and relative cardiac output detection data from a human subject, and an electrocardiogram trace measured simultaneously and independently, provided by a detection Foley catheter system according to an embodiment. From this graph, it can be clearly seen that the peak of the heart rate measured by the detection Foley catheter coincides with the heart rate.

[0058] FIG. 5 shows data related to the detection of relative cardiac output in a human leg-lifting exercise in which cardiac output increases as the amplitude of the cardiac pulse increases.

[0059] The data shown in FIGS. 6 and 7 were obtained from a study conducted using Yorkshire pigs under a protocol approved by the IACUC. FIG. 6 shows an example of peritoneal detection data centered on the respiratory rate from pigs, provided by a detection Foley catheter system according to an embodiment. FIG. 7 is a diagram showing an example of a pig test demonstrating the ability of a detection Foley catheter system according to an embodiment to detect intra-abdominal hypertension. In this study, the peritoneal cavity was accessed using a 5-mm Tenamian trocar. Following the trocar, a 5-L bag of lactated Ringer's solution was attached with a peristaltic pump and infused at a rate of approximately 1 L per minute. Once a pressure of approximately 20 mmHg (approximately 2.67 kPa) was obtained, the flow of fluid was stopped, and thereafter the net flow of fluid in and out of the cavity became zero.

[0060] FIG. 8 schematically shows the intra-abdominal pressure, respiratory wave pressure, and cardiac pressure arranged as a two-dimensional plot of pressure (mmHg on a logarithmic scale) versus frequency (Hz). There is an inverse correlation between pressure and frequency, and when arranged in this way, it can be seen that various physiological pressure-related parameters occupy distinct sectors. The fact that embodiments of the method disclosed herein can decompose one overall time-series pressure profile into different sub-profiles according to their physiological origin is due to the distinctness of both these pressure profiles and / or frequency profiles. Measurement of intra-abdominal pressure can be decomposed in the frequency range of about 0 Hz to about 0.5 Hz. Respiratory pressure measurement can be decomposed in the frequency range of about 0.25 Hz to about 0.75 Hz. Cardiac pressure measurement can be decomposed in the frequency range of about 0.75 Hz to about 3.0 Hz. Measurement of intra-abdominal pressure can be decomposed in the amplitude range of about 5 mmHg to about 30 mmHg (about 0.67 kPa to about 4 kPa). Respiratory pressure measurement can be decomposed in the amplitude range of about 0.5 mmHg to about 5 mmHg (about 0.067 kPa to about 0.67 kPa). Cardiac pressure measurement can be decomposed in the amplitude range of about 0 mmHg to about 0.5 mmHg (about 0 Pa to about 0.067 kPa). The sampling frequency (the frequency at which pressure measurements are made) is preferably about twice the resolution frequency. For example, the sampling frequency can be about 0 Hz to about 1 Hz for intra-abdominal pressure measurement, about 0.5 Hz to about 1.5 Hz for respiratory pressure measurement, and about 1.5 Hz to about 6 Hz for cardiac pressure measurement.

[0061] FIG. 9 is a flow diagram showing a method according to an embodiment for monitoring pressure dynamically generated as a wave whose frequency and amplitude change within the abdominal cavity and detected from within the bladder. A pressure interface generates a highly faithful pressure profile and transmits it proximally through a fluid column. More specifically, a pressure transducer converts a high-fidelity pressure wave into a high-fidelity electrical signal that encodes the frequency and amplitude of the pressure. The generated high-fidelity electrical signal is subsequently processed by a control unit to generate data subsets that reflect components within the overall pressure profile, and these subsets are attributable to specific physiological sources such as intraperitoneal pressure, respiratory rate, heart rate, relative cardiac output, and patient movement and activity.

[0062] Detection Foley catheter system

[0063] FIG. 10A is a diagram showing a detection-type Foley catheter according to an embodiment for use in combination with an airlock elimination mechanism and a body fluid collection and analysis system according to an embodiment. For both urine drainage and pressure measurement, it is effective to eliminate or reduce the airlock in the urine drainage line.

[0064] The detection Foley catheter 1000 is the same as the detection Foley catheter shown in FIG. 1. The detection Foley catheter is shown in the state of being used in the bladder 1014. Note that some of the ports at the proximal end of the catheter shown in FIG. 1 are combined in the embodiment shown in FIG. 10A. The urine drainage tube 1001 is also shown here. The urine drainage tube may be combined with the detection Foley catheter or may be a separate component. The urine drainage tube 1001 and / or the detection Foley catheter may include a vent valve (or valve) 1016, or the vent valve may be an individual component. The air lock elimination mechanism and the fluid collection and analysis system 1002 are also shown here and are in fluid communication with the urine drainage tube 1001 that is in fluid communication with the detection Foley catheter 1000. The air lock elimination mechanism and the fluid collection and analysis system include a base / control unit 1018, a fluid collection bag 1020, and a reservoir or cassette 1022. The combination of the detection Foley catheter 1000, the urine drainage tube 1001, the air lock elimination mechanism, and the fluid collection and analysis system 1002 will also be referred to herein as the detection Foley catheter system. The detection Foley catheter, the urine drainage line, and the reservoir / cassette are disposable and may be sold as a unit. This disposable assembly is shown in FIG. 10D and includes the detection Foley catheter 1000, the urine drainage tube 1001 (including the vent valve), and the reservoir / cassette 1022.

[0065] The vent valve 1016 can include one or more vents 1006, similar to the urine sampling port 1004. In this embodiment, the vent 1006 preferably consists of a membrane that allows the passage of gas, such as a hydrophobic membrane, but does not allow the passage of liquid. An example of such an exemplary vent is a membrane of PTFE (polytetrafluoroethylene), ePTFE (expanded PTFE), or Versapor (registered trademark, sold by Pall Corporation of Port Washington, New York), although other materials may be used. When negative pressure is applied to the drainage tube, air enters the system from the vent, and when an air lock occurs in the drainage line and the pressure becomes positive, air can escape from the system through the vent. Such a mechanism can prevent suction trauma, for example, on the bladder wall. The vent 1006 may incorporate a one-way valve that prevents air from exiting the drainage line or entering the drainage line. In a preferred embodiment, a one-way valve is used to prevent air from exiting the drainage line, but allows air to enter the drainage line through the vent 1006. In this way, the valve also prevents urine from contacting the vent 1006.

[0066] The urine drainage tube 1001 may include a plurality of lumens, including a pressure lumen 1010, a temperature lumen 1008, and a urine lumen 1012. The pressure lumen 1010 is in fluid communication with the pressure sensing balloon 108, similar to the pressure transducer interface 1026 of the control unit 1018. The temperature lumen 1008 communicates with a temperature sensor (not shown) within the sensing Foley catheter and also with the temperature connector port 1024 within the control unit. The urine lumen 1012 is in fluid communication with one or more openings 106 and a urine reservoir or cassette 1022.

[0067] The disposable measurement container, collection container, chamber or cassette element 1022 is adapted to a cassette mount, base or control unit 1018 and is configured to interface with elements of the control unit. The control unit pump interface (the back of the cassette pump interface 1148) connects to the pump 1134 and to the cassette pump interface 1148 on the disposable cassette element. The pump is configured to evacuate the interior of the cassette element and subsequently transfer it to the urine drainage lumen of the drainage line. Preferably, the collection container / cassette is rigid to maintain a constant volume when the pump applies negative pressure. The degree of negative pressure application can be monitored with a pressure sensor. When the air lock is released, the pressure will trace a sine curve as shown in FIG. 32. When suction is applied, the pressure decreases and ultimately reaches an inflection point when the urine meniscus passes the lowest point in the drainage tube. At this point, since the amount of suction required to continue releasing the air lock is small, once the air lock is completely released, the pump output can be reduced to minimize the amount of suction transmitted to the bladder. For example, in a large container without this pressure sensing function, after the air lock is released and before the container equilibrates with the atmosphere, a significant negative pressure will be applied to the bladder. The control unit pressure interface (the back of the cassette pressure interface 1150) connects to a pressure measuring device such as a pressure transducer and to the cassette pressure interface 1150. The pressure measuring device is configured to measure the volume of urine, or other fluid, based on the pressure exerted on a pressure measuring device which may be a pressure transducer. The ultrasonic transducer interface 1130 also performs urine volume measurement. Ultrasonic measurement can be used in combination with pressure measurement or either can be used to measure the amount of urine or other fluid. The active pinch valve 1132 is configured to connect to the outflow tube of the cassette. The pinch valve is for controlling the emptying of the cassette container and is controlled by the control unit to release urine / fluid when the amount of urine in the cassette measured by pressure and / or ultrasonic measurement reaches a predetermined amount.The urine volume in the cassette is measured, and when the urine reaches a predetermined amount, it is discharged into the urine drainage bag 1020 via a pinch valve, and the cassette is emptied. For example, the cassette can be emptied when the amount of urine in the cassette reaches about 50 ml. Alternatively, the cassette may be emptied when the urine volume in the cassette reaches about 40 ml. Alternatively, the cassette may be emptied when the urine volume in the cassette reaches about 30 ml. Alternatively, the cassette may be emptied when the urine volume in the cassette reaches about 20 ml. Alternatively, the cassette may be emptied when the urine volume in the cassette reaches about 10 ml. By doing so, the urine volume can be accurately measured over time.

[0068] In some embodiments, a capacitive micromachined ultrasonic transducer (CMUT) can be used to measure the urine volume in the cassette. Thereby, a less expensive ultrasonic transducer can be obtained that can cover the entire bottom surface of the cassette and / or one or more side surfaces of the cassette. Thereby, the inclination of the cassette may no longer be a concern.

[0069] By pressurizing the cassette during the process of the cassette being emptied, the empty state of the cassette may be enhanced or accelerated.

[0070] Alternatively, the control unit may utilize the set time while emptying the cassette and measure the volume of urine in the cassette immediately before emptying. Alternatively, the control unit can also empty the cassette when an event such as air lock release by pump operation occurs. For example, the control unit can set a regular air lock release cycle, then measure the urine volume in the cassette, and subsequently empty the cassette.

[0071] For example, when the urine volume reaches approximately 50 ml, the control unit can control the pinch valve to empty the reservoir / cassette. Alternatively, after measuring the urine volume in the cassette, the control unit may control the pinch valve to empty the reservoir / cassette every hour. Alternatively, during or after a urine discharge event such as the operation of the pump, the control unit may control the pinch valve to empty the reservoir / cassette. Or, by combining these triggers, the control unit can also control the pinch valve to empty the reservoir / cassette.

[0072] In addition to or instead of pressure and / or ultrasound, urine volume can also be measured using other techniques such as pressure-based, resistance-based, capacitance-based, ultrasonic-based, weight-based, or optical-based technologies. To improve the accuracy of volume measurement, it is also possible to use two or more techniques so that the measured values can be compared with each other. To obtain a more accurate urine volume measurement value, two or more volume measurement values performed by one or more techniques can be used for redundancy, or backup, or in combination with each other.

[0073] For example, by using a camera to recognize the fluid / air interface, the fluid level in the reservoir can be measured. The well-known dimensions of the reservoir can subsequently be used by the control unit to calculate the fluid volume. Also, by using a camera to identify the fluid / air interface and the end of the reservoir, the inclination of the system can be measured. The control unit can calculate the angle between these and measure the inclination of the system. If this angle changes rapidly over time, the control unit can determine that the system is moving, for example, when the patient is moving between rooms. The control unit can issue a warning when certain conditions are detected by the camera / control unit. For example, there are high-inclination warnings, movement warnings, detection warnings (when conditions such as blood or foam in urine are detected), etc. In a situation where the urine reservoir / system is placed on a horizontal plane, the inclination may approach 90 degrees. In such a situation, the control unit may determine that the reservoir is placed sideways and may not function properly, or that the likelihood of urine flowing back into the drainage tube increases. The control unit can automatically stop certain functions of the system, such as a drain line cleaning function, a function to empty the reservoir, etc. The control unit can automatically set the system to a "dam forry mode" in which the urine drainage flow path bypasses the cassette and is directly discharged into the bag. In addition to or instead of this, the control unit can block certain valves, such as a valve between the reservoir and the drainage tube.

[0074] The bed hook 1116 is for hanging the control unit on a bed or the like as needed. It is also possible to connect the control unit to a portable device for patient transportation. The collection bag hook / hole 1102 is for attaching a drainage bag where urine / fluid is finally collected after passing through the pinch valve. The collection bag hook 1102 may be configured to perform strain measurement so as to measure the weight of the fluid in the bag, thereby providing another method for measuring the volume of the fluid in the bag. For example, a piezoelectric transducer can be used. The measured value of specific gravity may also be used by the control unit to determine a useful volume measurement value based on the weight and specific gravity.

[0075] The screen 1110 is for displaying information including the current urine volume / body fluid volume status, the status of the system, etc. The screen 1110 may be a touch panel and can receive inputs including settings, changes in screen display, changes in menus, etc. The pressure port 1026 is connected to the bladder pressure line 1010 and, when used, measures the bladder pressure using a sensing Foley catheter. Alternatively, the pressure port may be arranged within the cassette mount under the cassette 1022 or elsewhere within the control unit / base. The temperature input port 1024 is connected to a thermistor / temperature sensor that measures body temperature via the lumen 1008 or other means. The temperature output port 1122 is for transmitting any temperature measurement values to an external device and / or monitor. The adapter port 1124 is for adapting the control unit to other devices, for example, an RFID adapter. This can be used to enable any additional / advanced functions such as the measurement of IAP, respiratory rate, heart rate, cardiac output, or other parameters that can be measured by the sensing Foley catheter. Thereby, additional parameters can be enabled only when that information is required, and the hospital can bear the cost. Also, the activation of advanced functions can be controlled, for example, by using different disposable components. Alternatively, advanced functions can be enabled as part of a disposable or by a separately purchased software upgrade. The software upgrade can be delivered by wireless, USB dongle, micro SD (registered trademark) card, EPROM card, or other suitable technologies. Also, the data of each patient and / or the data of the patient group may be stored by the control unit. Patient data can be stored in a memory, USB, micro SD (registered trademark) card, EPROM card, hard disk, etc. Patient data can be transferred to other storage devices such as servers on the Internet or intranet via wireless or wired connections. Patient data can be anonymized.Patient data such as patient ID is stored in the RFID adapter, so that data unique to a specific patient can be recognized by the control unit and associated with the disposable parts used by that patient. The RFID adapter may be placed in the disposable part of the system, for example, on the cassette 1022, or at other locations where the disposable component interfaces with the non-disposable component. In addition, since all the collected patient data is stored in the RFID adapter, it is also possible to use different monitors for the same patient without replacing the disposable part of the system.

[0076] The power LED / indicator 1114 indicates the ON / OFF of the power supply. The error LED / indicator 1112 is displayed when any error occurs within the system. Although the details of the error can be displayed on the screen 1110, the indicator 1112 warns the user that an error exists. Also, the indicator may include sounds and other warnings.

[0077] The port 1108 is for connecting to other devices, such as for downloading, uploading, software upgrading, and communicating with the EMR (electronic medical record) system. The port 1108 may be a USB port or other suitable port. The SD (registered trademark) port 1106 is for data downloading. The power port 1104 is for connecting the control unit to a power supply such as a wall socket to supply power to the control unit.

[0078] The urine / fluid drainage bag 1020 includes a one-way valve 1136 connected to an overflow tube 1138 and an outflow tube 1140, preventing urine / fluid from exiting the drainage bag once it has been collected. These valves may be passive or may be controlled by a control unit. These valves also prevent air from entering the collection container 1022 when the pump 1134 is creating a vacuum, such that the vacuum acts on the drainage tube rather than the bag. In a preferred embodiment, one valve is used for both the overflow tube and the outflow tube. The drainage bag 1020 can be removably attached to the control unit 1018 by attachment hooks / holes 1102. A vent 1142, which may be hydrophobic or other vent, allows air or gas to exit the drainage bag but does not allow fluid to exit the bag. This prevents excessive air and potentially pressure from building up within the bag, allowing the drainage bag to be efficiently filled. The graduated markings 1144 indicate a somewhat rough measurement of the fluid volume within the collected bag. An outflow valve 1146 may be used to empty the fluid / urine bag. Preferably, the valve is easily operable by one person. The collection bag hook 1102, when configured as a strain measurement element, can also force an alarm to sound when the bag is full and needs to be emptied. The alarm may also sound when an undue large force is applied to the bag, such as when the bag is pulled or caught on an obstacle during patient movement. Also, weight or mass can be used, for example, using a scale, to determine whether the bag is full. Alternatively or in addition, the pressure measurement within the reservoir / cassette can be used to determine that the bag is full.

[0079] Overflow barrier 1137 is shown in collection container / reservoir / cassette 1022. The overflow barrier is generally at a position higher than the water level at which the control unit empties the cassette. For example, if the control unit empties the cassette when the fluid volume reaches 50 ml, the overflow barrier reaches a height above the water level of a fluid volume of 50 ml. For example, the overflow barrier may be about 5 to 10 mm above the water level of the volume to be emptied. Alternatively, the overflow barrier may be about 10 to 20 mm above the water level of the volume to be emptied. Alternatively, the overflow barrier may be about 20 to 30 mm above the water level of the volume to be emptied. Alternatively, the overflow barrier may be about 30 to 40 mm above the water level of the volume to be emptied. Alternatively, the overflow barrier may be about 40 to 50 mm above the water level of the volume to be emptied. Alternatively, the overflow barrier may be about 50 to 100 mm above the water level of the volume to be emptied. The path between the urine collection region 1135 and the overflow region 1139 may be direct as shown here, or may be more serpentine or complex as shown in FIGS. 41B to 41E.

[0080] The patient's body temperature is measured using a thermistor / temperature sensor within the patient's body. This temperature may be displayed on a third-party device via the control unit. FIG. 10B shows a method of using a parallel potentiometer to reduce errors in body temperature measurement before transferring to an external display or external device.

[0081] The drainage bag can be formed of a suitable material such as transparent vinyl. The one-way valve can be formed of a suitable material such as vinyl. The hydrophobic vent can be formed from ePTFE, Versapor®, or other suitable materials. The outflow valve can be formed of a suitable material such as PVR, PC, etc.

[0082] The pressure measurement value from the detection Foley catheter may be used to operate the pump and empty the drainage tube. For example, when the pressure detected in the bladder exceeds a preset value, the pump can be activated to send urine to the drainage tube more quickly.

[0083] The control unit / base and / or reservoir / cassette can include an accelerometer or other sensor to determine when the control unit / cassette is horizontal and when it is not. An alarm may be sounded when the control unit / cassette is not horizontal. Alternatively, the urine volume measurement can also be adjusted taking into account different angles within the system.

[0084] The bottom surface of the urine reservoir in the cassette may be rounded or configured such that urine is completely emptied from the cassette when the pinch valve is open.

[0085] In certain embodiments, the control unit / monitor may be incorporated into the bed itself.

[0086] Figure 10C is a detailed diagram showing an airlock elimination mechanism and a fluid collection and analysis system 1002. The screen 1110 displays a touch screen or other user interface including control functions in addition to patient parameters. The heart rate area 1152 shows the patient's heart rate measured by the control unit based on the bladder pressure measurement detected by the detection Foley catheter. The respiratory rate area 1154 shows the patient's respiratory rate measured by the control unit based on the bladder pressure measurement detected by the detection Foley catheter. The core body temperature area 1156 shows the patient's core body temperature detected by a temperature sensor or the like in the detection Foley catheter. The urine volume area 1158 shows the current and / or average urine volume of the patient measured by the control unit based on the urine volume measurement measured by the pressure measurement device connected to the pressure interface 1150 and / or the ultrasonic oscillator interface 1130. The sepsis index area 1160 shows the likelihood of sepsis in the patient measured by the control unit based on one or more collected and / or calculated patient parameters. For example, factors such as abnormal body temperature, abnormal heart rate, abnormal respiratory rate, and / or urine volume can be considered in the determination of the sepsis risk. Also, the trend of these parameters can be used for risk assessment. For example, a decrease in urine volume, an increase in heart rate, an increase or decrease in core body temperature, etc. can be indicators of sepsis.

[0087] Other risk assessments can be determined by the control unit and displayed in addition to or instead of the sepsis index. These include risk assessments such as acute kidney injury, urinary tract infection, increased intra-abdominal pressure, abdominal compartment syndrome, infection risk, sepsis, ARDS (acute respiratory distress syndrome), etc. Figure 31A shows, for example, an example of a risk algorithm for acute kidney injury and urinary tract infection. Figure 31B shows an example of a risk algorithm for acute kidney injury, sepsis, and acute respiratory distress syndrome. The measured urine parameters may include conductivity, specific gravity, urine volume, presence or absence of infection, bacteria, white blood cells, oxygen concentration, etc.

[0088] The graphical indicator 1162 shows the historical data of any of these regions. For example, by touching the screen, the user can switch the graphic display to show the history of the patient's urine output, body temperature, heart rate, respiratory rate, sepsis index, risk of acute kidney injury, urinary tract infection, increased intra-abdominal pressure, abdominal compartment syndrome, risk of infection, etc., or other appropriate parameters. The time period of the history can be any period set by the user, such as the entire time period, daily, hourly, etc. Risk factors outside the range, i.e., risk factors in the increased risk, may be automatically displayed here or at other locations on the display. Warnings and / or ranges can be set by the user and can include absolute values and trends over time. For example, when the core body temperature rises by more than 2 degrees during a specific time period, a visual display or an audible warning can be given.

[0089] Figure 11A shows a detection Foley catheter system (including an airlock elimination mechanism, a fluid drainage, collection and analysis system / control unit) according to an embodiment similar to that shown in Figure 10A, where the vent 1180 is located on the control unit 1018 or the reservoir / cassette 1022 instead of the vent valve (or valve) 1182. In this embodiment, the vent 1180 is in fluid communication with the urine drainage lumen 1012 via a vent lumen 1184 that is fluidly connected to the urine lumen 1012 by the valve 1182. In this embodiment, compared with the embodiment shown in Figure 10A, the valve design is simplified and the drainage tube simply has an additional lumen. The vent can be provided anywhere in the system, and the fluid interface with the urine lumen can also be provided anywhere in the system.

[0090] FIG. 11B is a diagram showing a Foley catheter system for detection according to an embodiment similar to that shown in FIG. 11A. In this embodiment, a gas-permeable vent / filter is incorporated into cassette 1022 and / or control unit 1018. The vent lumen can pass through vent tube 1184 from barb 1182 along drainage tube 1012. The vent lumen may terminate outside the cassette and / or control unit, or as shown here, pass through the cassette and optionally the control unit and incorporate gas-permeable vent / filter 1180. Also shown in FIG. 11B is valve 1186. The valve may be a one-way valve, whereby fluid (e.g., air in the atmosphere) can flow through the vent lumen, through the barb, into the drainage tube, or to other locations along the drainage tube or Foley catheter, or into base / control unit 1018. This valve can prevent fluid such as urine and / or air from flowing from the vent tube and reaching the filter. The valve may be passive as shown here or actively controlled by the control unit. The valve may be located anywhere within the barb, at a location along the vent tube, within the cassette, within the control unit, or outside the control unit, e.g., on the non-patient side of the control unit, within or along the vent lumen.

[0091] In some embodiments, the valve is actively controlled via a control unit by controlling the negative pressure within the drainage tube. The valve opens when the control unit creates a negative pressure within the drainage lumen of the drainage tube, and may close when the control unit reduces the degree of vacuum applied to the drainage tube (i.e., applies less negative pressure to the drainage lumen, sets the pressure to zero, or applies a slight positive pressure to the drainage tube). Since the drainage lumen of the catheter and the drainage tube are in fluid communication with the lumen of the vent tube, the negative pressure applied to the drainage tube is also applied to the lumen of the vent tube, and the valve is configured to open when the differential pressure across the valve exceeds the cracking pressure of the valve. By reducing the degree of vacuum applied to the drainage lumen, and thereby reducing the differential pressure across the valve to a pressure below the cracking pressure of the valve, the valve can be closed again. Thus, even if the valve itself is a passive valve, the control unit can actively control the opening and closing of the valve within the vent tube.

[0092] In some embodiments, the control unit actively opening the valve may be performed periodically, for example, on a regular schedule. A graphical representation of this is shown in FIG. 11F. For example, the control unit may open the valve (represented by T1) at least every 30 minutes, keep the valve open for at least 15 seconds (represented by T2), and then close the valve for an additional 30 minutes until the cycle starts again. The difference between the vacuum applied to open the valve and the vacuum applied to maintain the closed valve is represented by DIFF in the figure. DIFF is greater than the cracking differential pressure 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.

[0093] In Fig. 11F, the valve closing pressure is shown to be negative, but the valve closing pressure may also be zero or positive.

[0094] Instead, the cycle length may be variable, and T1 and / or T2 may depend on the urine output flow rate. Alternatively, this cycle may be based on a system that detects an air lock in the drainage tube. This can be done by measuring the pressure within the system, such as the vacuum pressure within the drainage tube or the pressure at the valve.

[0095] In some embodiments, the valve 1186 can be in a predetermined position without a filter. In some embodiments, the filter may be between the drainage lumen and the valve 1186.

[0096] In some embodiments, the vent tube 1184 is provided integrally with the drainage tube 1012 along all or part of the length of the drainage tube.

[0097] The valve is a valve suitable for medical use, such as a duckbill valve, an umbrella valve, a ball valve, a dome valve, a bellville valve, a cross-slit valve, an X-fragm valve, etc. The crack pressure of the valve may be very low or very high, but generally it is between zero and the magnitude of the negative pressure sucked by the vacuum pump. In some embodiments, the crack pressure is essentially zero.

[0098] Fig. 11C is a diagram showing a sensing Foley catheter system according to an embodiment similar to that shown in Fig. 11B. In this embodiment, the vent tube includes a portion of the lumen with a smaller diameter between the valve and the barb. By reducing the inner diameter of the tube between the valve and the barb, a column of air can be formed between the valve and the barb, which generally prevents urine from entering the vent tube when the valve of the vent tube is closed. When the valve of the vent tube is open, the fluid flow generally flows in the opposite direction (i.e., into the drainage lumen), thus also preventing urine from entering the vent tube.

[0099] Figure 11D is a diagram showing an example of a vent tube having a variable diameter portion. The first section 1188 is the section closest to the patient, has an inner diameter of ID1, and a length of L1. In this embodiment, due to the valve 1186, generally the fluid can only flow from right to left as indicated by the dashed arrow. The second section 1190 is further away from the patient and has an inner diameter ID2 and a length L2. In some embodiments, L1 is smaller than L2 and ID1 is smaller than ID2. In some embodiments, ID1 is smaller than ID2, but the lengths may be different or the same as each other. L1 + L2 may be approximately the same length as the drainage tube.

[0100] In some embodiments, ID1 may be from about 1.8 to 2.0 mm. In some embodiments, ID1 may be from about 1.6 to 1.8 mm. In some embodiments, ID1 may be from about 1.4 to 1.6 mm. In some embodiments, ID1 may be from about 1.2 to 1.4 mm. In some embodiments, ID1 may be from about 1.0 to 1.2 mm. In some embodiments, ID1 may be from about 0.8 to 1.0 mm. In some embodiments, ID1 may be from about 0.5 to 0.8 mm. In some embodiments, ID1 may be from about 0.2 to 5 mm. In some embodiments, ID1 may be less than about 1 mm. In some embodiments, ID1 may be less than about 2 mm. In some embodiments, ID1 may be less than about 3 mm. In some embodiments, ID1 may be less than about 4 mm. In some embodiments, ID1 may be less than about 2 mm. Preferably, ID1 is small enough to hold a siphon for all or part of its length.

[0101] In some embodiments, ID2 may be from about 1.8 to 2.0 mm. In some embodiments, ID2 may be from about 1.6 to 1.8 mm. In some embodiments, ID2 may be from about 1.4 to 1.6 mm. In some embodiments, ID2 may be from about 1.2 to 1.4 mm. In some embodiments, ID2 may be from about 1.0 to 1.2 mm. In some embodiments, ID2 may be from about 0.8 to 1.0 mm. In some embodiments, ID2 may be from about 0.5 to 0.8 mm. In some embodiments, ID2 may be from about 0.2 to 5 mm. In some embodiments, ID2 may be less than about 4 mm. In some embodiments, ID2 may be less than about 5 mm. In some embodiments, ID2 may be less than about 6 mm. In some embodiments, ID2 may be greater than about 2 mm. In some embodiments, ID2 may be greater than about 3 mm. In some embodiments, ID2 may be greater than about 4 mm. In some embodiments, ID2 may be greater than about 5 mm. In some embodiments, ID2 may be greater than about 6 mm.

[0102] 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 from about 5 to 10 cm. In some embodiments, L1 may be from about 10 to 20 cm. In some embodiments, L1 may be from about 20 to 30 cm. In some embodiments, L1 may be from about 30 to 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.

[0103] In some embodiments, L2 may be from about 50 to 150 cm.

[0104] In some embodiments, ID1 and ID2 may be the same.

[0105] FIG. 11E shows a catheter system according to an embodiment in which a vent lumen 1184 is in direct fluid communication with a fluid collection bag 1020. In this embodiment, a control unit including a detection function may or may not be provided. In this embodiment, an air lock is avoided by a vent lumen that uses a vent 1142 of the fluid collection bag to ventilate the urine drainage lumen 1012. The vent can be provided at any location along the vent lumen in addition to or instead of this. The vent lumen may extend for part or all of the length of the drainage lumen. The urine drainage lumen is fluidly connected to the drainage bag at connection point 1192, which may include a valve 1136. The vent lumen is connected to the drainage bag at connection point 1194. The fluid collection bag 1020 in this embodiment, and potentially other embodiments, may include a rigid or semi-rigid portion 1196 to prevent the fluid collection bag from being inadvertently folded around connection point 1194. This embodiment may or may not include a valve 1186. The vent tube 1184 may be incorporated into the drainage tube system or may be an add-on component and is connected at the barb of the Foley catheter or in the vicinity thereof and the connection point 1194 of the drainage bag.

[0106] FIG. 12A is a diagram showing a sensing Foley catheter system according to an embodiment similar to the system shown in FIG. 10A. In contrast to the system shown in FIG. 10A, a pressure balloon is not utilized. Instead, the pressure within the bladder is measured through the urine lumen (or other lumen) of the sensing Foley catheter. In this embodiment, the pressure lumen 1202 is connected to a vent 1204 or elsewhere within the system outside of the patient's body and is in fluid communication with the drainage / urine lumen of the catheter at least periodically. 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. The system shown in FIG. 12A can also be used with a standard Foley catheter without using the pressure lumen 1202 when bladder pressure measurement is not desired.

[0107] Some embodiments of the Foley system for detection can measure the intra-abdominal pressure with a standard, i.e., commercially available, Foley catheter. Thereby, even when using a standard Foley catheter, the measured value of IAP can be incorporated into the analysis. In some embodiments, the control unit can cause the pump to introduce air or gas bubbles into the drainage line of the Foley catheter. By measuring the pressure of the drainage line with a pressure sensor, the control unit can determine the timing when the gas / air bubbles exit the Foley catheter and enter the bladder. The pressure required to extrude the fluid column containing bubbles into the drainage line increases until the bubbles exit the drainage line. The pressure when the bubbles exit the Foley catheter is equal to the intra-abdominal pressure. The fluid column may be solid or intermittent. The IAP measurement sequence may be periodically executed by the control unit. This can be executed either before or after eliminating the air lock. Also, the measurement of IAP can be performed manually while physically observing the pressure with a gauge such as a sphygmomanometer. Before performing this type of IAP measurement, the vent tube can be closed. The gas may be sterile and / or may be sterilized by ultraviolet light, for example at the barb portion, during transportation.

[0108] In some embodiments of the Foley system for detection, an irrigation lumen may be included in the Foley catheter, or a separate irrigation catheter having an irrigation lumen may be used to irrigate the bladder. In these embodiments, the control unit of the Foley system for detection can communicate with the irrigation pump so that the urine volume (excluding the irrigation fluid) can be accurately measured by subtracting the volume of the irrigation fluid from the measured fluid volume.

[0109] In an embodiment where a standard Foley catheter is used with a sensing Foley system, a dedicated clamp may be used to clamp one or more lumens of the drainage tube without clamping the urine drainage lumen of the drainage tube. The clamp may be configured to fit the drainage tube such that, for example, the pressure lumen of the drainage tube closes but the urine drainage lumen does not close.

[0110] FIG. 12B is a diagram showing a sensing Foley catheter system according to an embodiment that does not include measurement of IAP or temperature. Note that this embodiment also has an air-lock prevention function.

[0111] FIGS. 10A, 10C, 11, and 12 show embodiments of a sensing Foley catheter system that includes a vent near the patient-side end of the drainage tube that allows air to enter the drainage tube when negative pressure is generated by a siphon, a pump mechanism, or both within the drainage tube. Without a vent / filter, such negative pressure can cause suction trauma, such as trauma to the bladder mucosa. Note that these embodiments are different from devices that allow air to be discharged by one or more vents but not enter the drainage tube.

[0112] The urine drainage lumen preferably has an inner diameter of less than about 0.25 inches (about 0.63 centimeters), whereby the liquid in the lumen contacts the lumen circumferentially to form a seal and allows the liquid to be advanced when the pump mechanism is actuated. A plurality of drainage lumens may be provided so that the flow is not blocked even if the pump mechanism fails. In these embodiments, the drainage lumen is preferably generally empty, which may require continuous operation of the pump mechanism. Alternatively, the pump mechanism can be actuated before measuring the volume to confirm that all the liquid has been discharged, thereby reducing the power requirements of the device.

[0113] Some embodiments of the detection Foley catheter system include detecting a pressure spike in the drainage line while the pressure within the body organ is maintained constant, and generating a negative pressure within the drainage line using a pump until the pressure within the drainage line equals the pressure within the body organ.

[0114] In one embodiment, the vent has a resistance to air flow greater than the resistance to the flow of liquid from the patient, such that any accumulation of liquid within the patient is purged into the drainage line before air enters from the vent. For example, in the case of urine drainage, if the resistance of air through the vent is greater than the resistance of urine flowing through the patient's catheter, the full bladder will be emptied into the urine drainage line before air enters from the vent. However, in order to minimize suction trauma, it is preferred that the vent has the smallest possible resistance to ventilation while still meeting this requirement.

[0115] In another example, to further protect the bladder from suction, the vent has little to no resistance to air flow, and the control unit pump operates to relieve the airlock at more frequent intervals, such as every 1 minute, every 5 minutes, or every 10 minutes, and can keep the drainage line urine-free. When the pump operates, it continues to operate until it detects the absence of urine drainage indicating that the bladder is completely empty. Alternatively, the pump can operate for a set time, such as about 30 seconds, about 1 minute, about 3 minutes, about 5 minutes, about 10 minutes, etc. The control unit pump may be inactive during a predetermined time interval and may generate a "background vacuum" (a negative pressure lower than the airlock release pressure) during the airlock release time interval.

[0116] The pump mechanism used can be any suitable mechanism including, but not limited to, a peristaltic pump, a diaphragm pump, a vane pump, an impeller pump, a vortex pump, or other suitable pumps. The power supply for the pump can be supplied from an outlet, a battery, manual power, or other suitable power sources. In some embodiments, the vacuum is in the range of about 0 to -50 mmHg (about 0 to about -6.67 kPa). Alternatively, the negative pressure can also be supplied by a wall vacuum commonly found in hospital rooms. The pump mechanism can include a peristaltic pump or suction directly applied to the collection container. The pump may be placed on the patient side of the drainage reservoir, but preferably the pump is placed on the non-patient side of the drainage reservoir / cassette such that the reservoir is between the patient and the pump. To function properly, the pump preferably can generate a negative pressure equal to the maximum fluid column height in the drainage tube. This may be half the length of the drainage tube. When the length of the urine drainage tube is up to 60 inches (about 1.524 meters), the maximum negative pressure required is about 30 inH2O or 56 mmHg (about 7.47 kPa).

[0117] Other techniques can be used to encourage urine through a tube and / or system including pulsatile mechanical, vibroacoustic, thermal, vibrational, pinching, rolling, or electromagnetic stimulation and cause movement of at least one of the drainage line and the body fluid therein. In some embodiments, the rolling stimulation includes sequentially compressing a plurality of lumens such that the lumens are never all compressed simultaneously.

[0118] In another example, the drainage lumen elimination mechanism consists of a tube having an inner diameter of less than about 0.25 inches (about 0.64 centimeters) so that the air pocket cannot move the length of the tube. This is to prevent fluid movement due to surface tension in the smaller tube when one end of the tube (as in the bladder example) is closed to the atmosphere. For this reason, urine always accumulates in the drainage tube to the brim, and since urine is incompressible, the same amount of urine must exit the drainage tube each time urine exits. In another example, the inner diameter is less than 0.125 inches (3.175 millimeters). In another aspect, the drainage tube serves as a siphon and applies a safe small amount of vacuum to the bladder. Instead of this, in a small lumen drainage tube, air can be periodically introduced into the tube lumen from the vent / valve. Negative pressure by a pump may facilitate this. The negative pressure by the pump causes urine to continuously flow into the collection reservoir and prevents an air lock.

[0119] Also, by using a small-diameter tube, the residual urine volume in the drainage tube is reduced compared to the prior art. A smaller residual volume is preferable because the movement of urine from the patient's bladder to the collection container is faster. The speed of this transport is important for measuring newly generated urine. In particular, it is important for patients with low urine production because it takes even more time for the urine to be transported from the bladder to the collection container. For example, in the case of a patient who excretes only 10 mL of urine per hour (residual volume of about 40 mL) with a standard drainage tube, when measuring the urine in the collection container, there is a 4-hour delay in actual urine production. On the other hand, in the case of a smaller tube (a tube with a residual volume of about 5 mL), the measurement is only delayed by about 30 minutes from actual production. In embodiments using a small-diameter lumen, a pump for supplying negative pressure to the drainage line is not necessary regardless of the presence or absence of a vent / valve.

[0120] FIG. 13 is a diagram showing an apparatus according to an embodiment suitable for a drainage tube such as a thoracic tube that applies a certain negative pressure to a patient. These embodiments may also be suitable for draining urine from the bladder or fluids from other cavities. Any of the features disclosed in connection with thoracic tube drainage can also be applied to bladder drainage or other body cavity drainage. Liquid is drained from the patient through a drainage lumen 1585 that connects to a collection container 1382. Drainage is assisted by applying a negative pressure to the collection container 1382, for example, by attaching a suction tube 1383 to hospital wall suction. Suction can also be performed using other methods, such as a pump as disclosed elsewhere in this specification. Air enters the drainage lumen 1385 through a valve 1384, which has a crack pressure equal to the desired negative pressure. By selecting the correct crack pressure (e.g., -15 to 0 mmHg (about -2 to 0 kPa), or -10 mmHg (about -1.33 kPa)), the pressure applied to the patient remains at this pressure as long as the hospital wall suction / pump can generate sufficient suction in the collection container 1382. Preferably, one or more drainage lumens used for draining the thoracic tube are made as large as possible while maintaining a siphon. Suitable inner diameters include, but are not limited to, about 1 / 4 inch (about 0.64 centimeters), about 5 / 16 inch (about 0.8 centimeters), or about 3 / 8 inch (about 0.95 centimeters).

[0121] FIG. 14 is a diagram showing an apparatus according to another example suitable for a drainage tube such as a thoracic tube that applies a certain negative pressure to a patient. Liquid is drained from the patient through the drainage lumen 1488, and a negative pressure is applied using the pump mechanism 1486. The pressure sensor 1487 is provided in the drainage tube on the patient side, thereby measuring the pressure applied to the patient. The measurement value obtained by the sensor 1487 is returned to the control unit that controls the pump mechanism 1486, and the pressure generated by the pump mechanism 1486 is adjusted to maintain the pressure at the sensor 1487 (and the patient) at a desired level. Also, the pressure sensor 1487 may be arranged at other locations in the system. This sensor can also be used to passively monitor the pressure on the patient side of the tube and provide information regarding the level of suction applied to the clinician. Although FIG. 14 shows the pump on the patient side of the drainage reservoir, the pump may instead be provided on the opposite side of the drainage reservoir, and the reservoir may be provided between the patient and the pump.

[0122] In another example of the present invention used for drainage of a thoracic tube, the volume of the drained fluid is measured in order to provide information regarding the drainage state of the thoracic tube to the clinician. This measurement can be achieved by any suitable means, particularly the means described herein for measuring urine volume.

[0123] In addition to eliminating air locks, some of the above air lock elimination configurations have been found to effectively remove deposits and blood clots from the urine drainage line. These issues plague current urine drainage tubes, particularly those with smaller lumen drainage tubes, and monitoring techniques in drainage bags. The present invention aims to improve the state of the art by automating the removal of debris and blood clots that obstruct these drainages. This function is particularly useful when used in combination with a pressure sensor within the balloon at the Foley tip or in fluid communication with the bladder. This allows monitoring of the pressure and vacuum within the bladder and enables more aggressive fluid delivery based on the actual bladder pressure until the blood clot / obstruction is resolved. Without this pressure / vacuum sensing, when pumping fluid through the drainage tube, the bladder mucosa can be exposed to excessive vacuum, potentially resulting in clinical sequelae such as suction trauma within the bladder.

[0124] As shown in FIG. 15, the active vent system consists of an air vent 1502, a drainage line 1504, a collection container 1506, and a pump 1508. The vent side of the drainage line is connected to the patient. In one embodiment, the fluid being drained is urine and the connection is made to a urethral catheter. The fluid flows from the patient 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 applies a vacuum to the collection container. By applying a negative pressure to the collection container, the pump pushes the fluid out into the drainage line, facilitating drainage. Preferably, the collection container is rigid 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 permeation of gas (preferably air) but prevents the permeation of liquid. This vent can prevent atmospheric air from entering the system and applying a substantial negative pressure to the patient. Such a mechanism can prevent suction trauma, for example, to the wall of the bladder.

[0125] The pump of this system may be any type of pump suitable for pumping gas, such as a peristaltic pump, a diaphragm pump, a centrifugal pump, etc., but is not limited thereto. In order for the pump to function properly, it is preferably capable of generating a negative pressure equal to the maximum fluid column height in the drainage tube. This may be half the length of the drainage tube. When the length of the urine drainage tube is up to 60 inches (about 1.524 meters), the maximum negative pressure required is about 30 inH2O or 56 mmHg (about 7.47 kPa).

[0126] As shown in FIG. 16, the active venting system for discharging body fluids may have additional vents. One such vent, vent 1662, may be provided in the collection container and can vent air from the collection container. This can prevent a pressure increase by canceling out an equal volume of air from the system for each volume of fluid entering the system each time new fluid enters the container. Another such vent, vent 1664, may be disposed between the collection container and the pump. This vent allows the permeation of gas (preferably air) but prevents the permeation of liquid, which is to prevent bacteria and viruses from entering and leaving the collection container and the drainage tube. Preferably, this vent is of a sterile grade, i.e., the air passing through is considered sterile. A vent (not shown) may or may not be provided on the patient side of the drainage line.

[0127] As shown in FIG. 17, pressure cancellation can be achieved with one vent provided in the collection container. In this case, the vent 1772, which is a ventilation port, may be provided between the collection container and the pump as before, but with an additional valve 1774, air can be released from the collection container in the presence of positive pressure. This valve is preferably a one-way valve that can let air out of the system but not in. When the pump operates, the one-way valve closes, and since it is necessary to suck air from the collection container, a negative pressure is generated in the collection container, making it easier for fluid to flow from the drainage line. A vent (not shown here) may or may not be provided on the patient side of the drainage line.

[0128] Detection of infectious diseases

[0129] FIG. 18 is a diagram showing a collection container, chamber or cassette according to one embodiment that may be included in a detection Foley catheter system for detecting bacteria, blood and / or other substances in urine using ultraviolet / Raman spectroscopy. Cassette 1800 preferably includes a container wall 1802 that is rigid. Urine 1806 is collected in the cassette. The overflow region 1804 allows any excess urine to be drained from the cassette if the urine is collected too quickly, or if there is any impediment to the cassette becoming or emptying sufficiently quickly (e.g., in situations of high urine flow). Cassette 1800 may preferably include an optically transparent section 1810 incorporated into the outer wall of the cassette and a reflective section 1812 preferably on or incorporated into the inner wall of the cassette. As used herein, "optically transparent" means that light at the required analysis wavelength(s) can be transmitted through the optically transparent section. Preferably, it is an optically transparent section formed of a material that can transmit ultraviolet rays, such as polymethyl methacrylate, polystyrene, acrylic, quartz, etc. The wall thickness may need to be thin enough for the appropriate one or more ultraviolet wavelengths to pass through the optically transparent section. For example, the thickness of the optically transparent section may be from about 0.5 mm to about 0.7 mm. Alternatively, the thickness of the optically transparent section may be from about 0.5 mm to about 0.6 mm. Alternatively, the thickness of the optically transparent section may be from about 0.6 mm to about 0.7 mm. Alternatively, the thickness of the optically transparent section may be less than about 0.7 mm.

[0130] The ultraviolet / light transceiver 1808 transmits ultraviolet light or other wavelength light of an appropriate wavelength through the urine in the cassette to the reflector 1812 in the cassette via the optically transparent part 1810. The ultraviolet / light transceiver may be incorporated into or connected to the control unit components of the Foley catheter system for detection. The light is reflected to the ultraviolet / light receiver, and the collected data is transmitted to the control unit for signal analysis. Multiple ultraviolet / light wavelengths can be analyzed simultaneously or sequentially. In addition to light in the ultraviolet region, light outside the ultraviolet region can also be used. The amount of urine physically present between light transmission and light reception is preferably maximized for a stronger signal reflecting the concentration of one or more substances in the urine. The transceiver may be arranged as shown in FIG. 18 or in other regions of the cassette. The receiver is provided at a location separate from the transmitter, and the reflector may or may not be required and may not be provided. Since the urine in the cassette is frequently emptied, ultraviolet / light absorption measurements can be collected over time to track the increase or decrease in the level of one or more substances in the urine, essentially or approximately in real time. This is particularly important for early identification of infectious diseases such as urinary tract infections and catheter-associated urinary tract infections (CAUTI). Ultraviolet / light detection can also be performed at other locations in the Foley catheter system for detection, such as in the drainage tube or individual sampling areas.

[0131] Infections can be identified by analyzing bacteria, red blood cells, plasma, and / or white blood cells in urine using ultraviolet / optical spectroscopy. FIG. 19A is a diagram showing various absorption wavelengths of Escherichia coli, red blood cells, and plasma in urine with respect to light. The presence of plasma / white blood cells and / or bacteria in urine all serve as indicators of infection. The presence of red blood cells may not suggest an infection. Therefore, it is desirable to distinguish red blood cells in urine from bacteria / plasma / white blood cells. Since red blood cells have significantly different spectroscopic characteristics from bacteria and plasma / white blood cells, the signal of red blood cells can be separated from the signals of bacteria and / or plasma / white blood cells at a wavelength of approximately 414 nm, and infections can be identified by analyzing the absorption of light at this wavelength. Since plasma and bacteria have different signatures at wavelengths of 260 nm and 280 nm, these wavelengths can be used to distinguish plasma from bacteria. However, both plasma and bacteria may be present during an infection.

[0132] Broadband spectral spectroscopy can be used over a continuous wavelength range and over time. Signal deconvolution or demixing can be used to determine the amount of the analyte and / or form the basis of features for developing analysis algorithms.

[0133] In addition, various substances in urine and collected / excreted body fluids can also be detected using other wavelengths and other technologies. Turbidity can also be detected using ultraviolet / light absorption. Also, dyes, drugs, and reactive substances can be introduced into the system or coated on the inside of the system, cassette, etc., to react with substances in urine and assist in the analysis. Any type of sensor that can detect the substances and properties of the collected urine intermittently or continuously in real time can be used. For example, a sensor (s) for detecting magnesium in urine can be used for the diagnosis of preeclampsia and eclampsia. A lactate sensor can be used to examine lactate (or lactate dehydrogenase) in urine. The identification of lactate in urine may be an early indicator of sepsis. The lactate sensor may include an enzymatic lactate sensor. For example, a lactate sensor 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 these documents are hereby incorporated by reference in their entirety.

[0134] The wavelengths of visible light can also be used. For example, a camera that captures visible light can be used to monitor the collected urine over time. From the images collected by the camera, the wavelength of the color, turbidity, intensity of the color, consistency or inconsistency of color and / or intensity and / or turbidity, cloudiness, presence of blood or thrombus, hemolysis, bubbles, proteins, etc. can be analyzed. Since the urine images can be captured at substantially any time interval from several hours to several days, it is possible to monitor the presence or absence of factors indicating the patient's condition and changes representing changes in the patient's condition from the urine. For example, dehydration (based on the degree of yellow color of urine), bleeding (based on the presence of blood), proteins in urine (based on the bubbles in urine), and congestion (based on cloudiness, bubbles, color, turbidity, etc.) can be identified. When using a camera to evaluate the characteristics of the collected urine over time, it may be important to evaluate the most recently collected urine in small amounts so that the urine is not diluted by older collected urine. This can provide feedback on the patient's condition substantially in real time. To achieve this, the camera can be directed at the urine at the inlet portion of the cassette 1800, for example, the lower part of the drainage tube, or the upper part of the cassette, or where the drainage tube connects to the cassette.

[0135] Reference colors are included in the system, such as in a cassette, and can be used to calibrate the camera to reference red, blue, and green colors. For example, reference regions of red, green, and blue (such as a reference seal having red, green, and blue regions) can be placed near the camera (inside or outside the cassette) and on the opposite side of the cassette such that the camera can view both. The nearby reference calibrates the camera to the color in the absence of urine, and the distant reference results in the same color as seen by the camera through the urine.

[0136] Image processing of the images collected by the camera / wavelength detector may be executed by the control unit. Steps of image processing may 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 network, partial differential equation, pixelation, principal component analysis, self-organizing map, wavelet, filtering, noise removal, edge enhancement, contrast enhancement, morphology, dilation, erosion, Fourier transform, etc.

[0137] When, for example, the color of urine is outside the normal range, the inclination of the system is outside the allowable range, the system changes the inclination angle more frequently than the preset frequency, the turbidity of urine is outside the normal range, blood, or other abnormal substances are detected in the urine, etc., when the camera detects something outside the preset range, the control unit can warn the user.

[0138] In an embodiment where a visible wavelength camera is used, live or semi-live video of urine in the system can be projected from a remote location. For example, the state of the urine reservoir / cassette can be projected onto a table, computer, phone, monitor, etc. in the room. This function can hide the urine in the reservoir and / or urine bag near the patient, making it more comfortable for the patient and their visitors. That is, the actual urine near the patient can be hidden or covered with an opaque material, and the urine image feed can be displayed elsewhere. The urine contained in part or all of the cassette, drainage tube, urine bag, etc. may be hidden by an opaque material.

[0139] Figure 19B shows a display 1110 according to one embodiment on the control unit / monitor 1018, including the current values and past trends of IAP, temperature, urine volume, and urine color. The color of urine may be detected via the camera disclosed in this specification. In this figure, it is shown in black, white, and grayscale, but actual colors such as yellow, orange, red, etc. can be displayed. The setting 1902 may be available for displaying different historical ranges of data, including 1 hour, 6 hours, 12 hours, 24 hours, etc. Clicking on the small color box to expand it allows viewing of actual photographic images and videos of the urine color, turbidity, cloudiness, foam, etc. at that time.

[0140] Note that the embodiments disclosed in this specification show the user interface display on the control unit / monitor. However, the display, or components of the display, or the collective display can be additionally or alternatively displayed on a computer, mobile computer, mobile phone, tablet, another monitor / screen, etc. For example, it is possible to display a part of the display on a portable tablet and use the tablet individually or dock it to the control unit / monitor for use. Devices such as tablets and mobile phones can be synchronized with the control unit using proximity, RFID, etc. The display can display information regarding individual patients and / or, for example, at a nurse station, etc., information regarding multiple patients. The display may display the data of multiple patients individually or aggregate and display the data of multiple patients. Also, the display has multiple different screens built-in and can be accessed by switching the screens. In some screens / displays, login authentication for administrators may be required, such as when adjusting the settings of the Foley system.

[0141] Alternatively, or in addition, mechanisms such as RFID can be used to prevent the unauthorized "piracy" and use of disposable parts of the system. In this way, the control unit / monitor can recognize the disposable parts of the system as permitted / non-permitted. The system may issue a warning to the user and may not function if there are unauthorized disposable parts. The same ID mechanism can also be used to control the functions of the system. For example, the user may be required to pay a subscription fee to access the IAP function of the system. The same disposable unit can be used by those who have subscribed to the IAP function and those who have not, but the control unit can be programmed to reflect the details of the subscription, and the ID mechanism may be used to permit the disposable IAP function to function for those who have subscribed to this function. Due to the nature of the ID, the IAP function may not function for those who have not subscribed to this function. Alternatively, instead of this, the control unit can cause the function to function only once or a limited number of times for those who have not subscribed to the function.

[0142] Drugs or residual drugs can be detected from the collected urine using appropriate sensors. In addition, substances or properties of the collected urine that can be detected include color, transparency, odor, specific gravity, weight osmolarity, pH, protein, glucose, creatinine, nitrite, white blood cell esterase (WBC esterase), ketone, red blood cells or white blood cells, casts, crystals, bacteria, yeast cells, parasites, squamous epithelial cells, etc., and are diverse.

[0143] CAUTI or infectious diseases can be identified and / or reduced by several methods as follows: analyzing urine using spectroscopy, light wavelength analysis, etc., early identification of contaminants, reducing trauma caused to the bladder by suction, reducing urine retention in the bladder, reducing the presence of bacteria or microorganisms by using an antibacterial coating of a material such as silver or an embedded material, increasing the accuracy of bladder pressure measurement by reducing suction in the bladder, increasing the accuracy of urine volume measurement by reducing air locks in the system and suction in the bladder, etc. The pressure spike due to bladder suction can be defined as a pressure measurement value of less than about -20 mmHg (about -2.67 kPa). Alternatively, the pressure spike due to bladder suction may be defined as a pressure measurement value of less than about -10 mmHg to about -20 mmHg (about -1.33 kPa to about -2.67 kPa). Alternatively, the pressure spike due to bladder suction may be defined as a pressure measurement value of less than about -10 mmHg (about -1.33 kPa).

[0144] CAUTI can also be reduced by using ultraviolet light, or light of any effective wavelength, or radiation to reduce bacteria in the urine and / or in the system. The urine can also be treated using UV light that sterilizes the urine in the cassette or other locations within the system. For example, the ultraviolet light can sterilize the urine when it enters the cassette, e.g., at the inlet valve 4104 as shown in FIG. 41A, or within the cassette, or above the cassette, e.g., in the drainage tube above the cassette.

[0145] FIG. 20 is a diagram showing a cassette according to an embodiment, including a partition or flap 2002. This partition / flap is for preventing urine from seeping along the inner wall of the cassette, as indicated by the dotted arrow. To prevent urine from seeping at the tip of the partition, the urine returns and falls into the lower measurement reservoir.

[0146] Priming

[0147] An aspect of the disclosed technology that is particularly advantageous for achieving a high-resolution signal capable of monitoring pressure profiles (such as intraperitoneal pressure, respiratory rate, and heart rate, relative pulmonary ventilation volume, cardiac output, relative cardiac output, and absolute cardiac output, etc.) from a specific physiological source relates to adjusting and maintaining the balance of pressures on both sides of a pressure interface represented by the membrane of a pressure-sensing balloon. This balance of pressures may be referred to as a differential pressure. In some embodiments, a preferred differential pressure is zero or in the vicinity thereof. In some embodiments, the preferred differential pressure may be a different value. The pressure applied to the outer surface of the balloon (the surface facing the inner surface of the bladder) varies according to the physiological state of the patient. The pressure applied to the inner surface of the balloon (the surface in fluid communication with the fluid column) is subject to degradation due to fluid leakage and seal imperfection.

[0148] When a sensing Foley catheter is first inserted, usually an external pressure is applied to the fluid column, and a first approximate pressure is applied to the pressure interface with respect to the pressure applied from inside the bladder to the pressure interface. The pressure signal is measured across the pressure interface and has a maximum amplitude when the differential pressure is approximately zero. Therefore, the amplitude of the pressure signal can be utilized to adjust the pressure applied from the fluid column to the pressure interface. Applying an appropriate pressure to the interface in this way is sometimes referred to as priming the fluid column or priming the balloon. Since the pressures on both sides of the pressure interface change as described above, the fluid column sometimes needs to be re-primed or readjusted. The need for re-aspiration can be monitored by performing a test of slightly changing the pressure so that the profile of the pressure signal reaches its maximum amplitude. Alternatively, it is also possible to automatically perform priming periodically via a control unit.

[0149] Embodiments of the disclosed systems and methods include automatic pressure regulation by a control unit. Thus, the regulation system can monitor the detected pressure signal and detect the optimal target pressure and amount to inflate the balloon by adding or removing air or fluid volume as needed. For example, during catheter insertion, a pressure regulation circuit that adjusts balloon volume and pressure can inflate the balloon until it detects a physiologically-based pressure rate. Once the pressure rate is detected, the pressure regulation control unit can add or subtract a small amount of air in a series of routine or programmed steps until the detected wave amplitude is maximized. The control feedback loop between the optimally adjusted pressure (manifested as balloon pressure and volume) and the detected physiological pressure profile is continuous or repeated as needed to ensure a highly accurate measurement of physiological data. In some embodiments, the automatic pressure regulation may be performed in an apparent background while physiological data is being transmitted and displayed. In other embodiments, the system may pause the transmission of physiological data during the pressure regulation sequence.

[0150] Embodiments of the disclosed technology include a gas supply system that can supply gas during a priming operation, whereby pressure can be applied to the fluid column proximal to the side facing the proximal side of the pressure interface. A gas supply source such as compressed air or liquid is held in a storage tank. Taking CO 2 as an example, CO 2 is controllably released from the storage tank through a pressure regulator that can reduce the pressure in the tank (e.g., about 850 psi (about 5.86054 MPa)) to a range of about 1 psi (about 6.9 kPa) to about 2 psi (about 13.8 kPa). The released gas passes through a filter and through a pressure relief valve set at about 2.5 psi (about 17.2 kPa). The pressure relief valve is a safety element that prevents gas at a level exceeding 2.5 psi (about 17.23 kPa) from flowing in the event of a failure of the upstream regulator. The CO 2Next, it enters the catheter line through the filling valve of the first solenoid control and finally fills the balloon that constitutes the pressure sensing interface. When the pressure inside the balloon rises to 30 mmHg (about 4 kPa), the first solenoid valve closes. The second solenoid control valve on the distal side of the first valve operates as a drain valve and can release the pressure from the catheter to the target pressure. Alternatively, the drain valve can be operated until a respiratory waveform is detected, and then the balloon can be optimally primed and the valve closed. The drain valve enables proportional control operatively based on voltage or pulse width modulation (PWM), which allows for a sufficiently slow drain rate so that the valve can be closed before reaching and overshooting the target pressure. Alternatively, an air pump such as a peristaltic pump can be utilized to fill the balloon with room temperature air.

[0151] Figure 21 is a graph representing the method of priming a pressure balloon in some embodiments. Here, a small volume burst (roughly about 0.3 cc) is added to the pressure sensing balloon and the pressure inside the balloon is measured. Small fluid bursts are introduced until the measured pressure inside the balloon settles to a stable pressure 2101. This transition is indicated by the inflection point 2102. After this point, a volume burst is introduced until the measured pressure starts to rise rapidly (for example, when the slope 2104 of the curve is greater than about 2 mmHg (about 266.645 Pa) / 10 ms). This inflection point is shown at 2106. At this point, the pressure inside the balloon is reduced to a pressure near or slightly higher than the stable pressure 2101. This pressure represents the main pressure measurement pressure in some embodiments. This process is also represented in the flowchart of Figure 24.

[0152] Alternatively, priming of the pressure balloon can involve pressurizing the pressure balloon well above 0 mmHg (0 Pa), then venting a small amount of air / gas / fluid and monitoring the pressure of the pressure balloon. The pressure of the pressure balloon stabilizes, i.e., becomes flat, as it approaches the optimal priming pressure. To determine this optimal pressure, pressure measurements are taken while venting a small amount of air from the pressure balloon, and if the subsequent pressure measurements are essentially the same (within about 2 mmHg (about 0.267 kPa) of each other), the balloon is at the optimal priming pressure. If the two measurements are not equal, the pressure balloon is repressurized well above 0 mmHg (0 Pa) and this process is repeated. The pressure measurements taken while venting a small amount of air from the pressure balloon can be taken over a period of about 5 to about 15 seconds to correct for the effect of respiration on the pressure measurement. In some embodiments, after a small amount of air / gas / fluid has been removed from the pressure balloon before a pressure measurement is taken, the pressure signal may require a short stabilization period.

[0153] A small fluid burst of about 0.2 cc to about 0.4 cc may be ejected. A small fluid burst of about 0.1 cc to about 0.5 cc may be ejected. When a small fluid burst is ejected, it may be up to about 0.5 cc. When a small fluid burst is ejected, it may be up to about 1.0 cc.

[0154] FIG. 22 is a graph representing a method of priming a pressure balloon in some embodiments. This method is the same as the method shown in FIG. 21, except that there is no burst as shown in FIG. 21 and the pressure in the pressure sensing balloon increases more smoothly. Fluid is introduced into the pressure sensing balloon and the pressure inside the balloon is measured. The balloon pressure is increased until the measured pressure inside the balloon settles at a stable pressure 2205. This transition is indicated by an inflection point 2206. The balloon pressure is increased beyond this point until the measured pressure begins to rise rapidly (e.g., when the slope 2210 of the curve is greater than about 2 mmHg (about 266.645 Pa) / 10 ms). This inflection point is shown at 2208. At this point, the pressure inside the balloon is reduced to a pressure near or slightly higher than the stable pressure 2205. This pressure corresponds to the optimal or prime pressure in some embodiments. This process is also represented in the flowchart of FIG. 25.

[0155] Figure 23 is a flowchart showing the priming process of a balloon according to an embodiment of the present invention. Embodiments of the disclosed system and method include automatic pressure adjustment by a control unit. Thus, the adjustment system can monitor the detected pressure signal and detect the optimal target pressure and amount to inflate the balloon by adding or subtracting air as needed. For example, once the catheter is inserted, the pressure adjustment circuit that adjusts the balloon volume and pressure inflates the balloon until it detects a physiology-based pressure ratio. The pressure adjustment control unit that has detected the pressure ratio adds or subtracts a small amount of air or fluid (roughly about 0.3 cc) in a routinized order until the amplitude of the detected wave is maximized. The control feedback loop between the optimally adjusted pressure (appearing as the balloon pressure and volume) and the detected physiological pressure profile is continuous or repeated as needed to ensure a highly faithful measurement of physiological data. In some embodiments, the automatic pressure adjustment may be performed in an apparent background while physiological data is being transmitted and displayed. In other embodiments, the system may pause the transmission of physiological data during the pressure adjustment sequence.

[0156] The small amount of air or liquid can be from about 0.2 cc to about 0.4 cc. The small amount of air or liquid can be from about 0.1 cc to about 0.5 cc. The small amount of air or liquid can be up to about 0.5 cc at most. The small amount of air or fluid can be up to about 1.0 cc at most.

[0157] In some embodiments, the priming of the balloon may be based on the characteristics of the system. The pressure balloon can be inflated once, twice, or more to characterize a system that includes an ultrasonic oscillator, a pressure pump, resistance within the system, the pressure balloon, etc. The pressure balloon may be pressurized at a range of pressures to determine the characteristics of a particular system at that time. This information can subsequently be used to optimize the inflation pressure of the pressure balloon.

[0158] Loop control unit

[0159] Specific patient parameters measured by a sensing Foley catheter system or other means are affected by and / or affect the treatment of the patient by the medical treatment device.

[0160] The loop control unit is provided integrally with the control unit of the sensing Foley catheter system (either within the same device or in a separate device) and can interpret the patient parameters to control the medical treatment of the patient.

[0161] For example, IAP can be used to control the infusion rate of intravenous injection. When IAP becomes too high, the infusion rate can be reduced or stopped until IAP returns to the acceptable range. By combining IAP with at least one of relative stroke volume and stroke volume variation (such as the variation in the magnitude of the heartbeat seen in the bladder during the respiratory cycle), IAP can be used as an indicator of over-infusion, and an increase in relative stroke volume and a reduction in stroke volume variation can be used as indicators that additional infusion is necessary, enabling excellent control of intravenous infusion or the drip of blood products. Urine output can be further added to the control loop to indicate that the body fluid state has recovered due to the recovery of urine output. The combination of heart rate and respiratory rate may be used for the control of drug injection (type of drug, infusion rate, frequency, dosage, etc.). Thus, drugs may be used to make the patient judged by heart rate and respiratory rate more stable. IAP and respiratory rate can also be used for the control of mechanical ventilators and respirators. When IAP rises, the positive end-expiratory pressure ventilation (PEEP) supplied by the mechanical ventilator should also rise to overcome this pressure. Indicators indicating insufficient ventilation can be seen in tissue oxygenation and / or spontaneous respiratory rate, which can be regarded as signals underlying mechanical ventilation. This signal may be extracted during mechanical ventilation, or preferably, the loop control unit may temporarily stop the mechanical ventilator to more precisely and accurately detect the underlying respiratory rate / respiratory drive. This IAP, tissue oxygenation, and / or respiratory rate may be used to warn medical providers of the deterioration of the patient's symptoms and / or to automatically adjust ventilator settings including respiratory rate, PEEP, %O2 inhaled, and other settings. In an ideal scenario, based on information obtained through machine learning and algorithm adjustment, the loop control unit can use these parameters to monitor and control the treatment. These are just examples, and there are many combinations. One or more parameters can be used to control one or more treatment devices.

[0162] FIG. 26 is a diagram showing a loop control unit according to an embodiment in a patient environment. In this example, the loop control unit is receiving patient parameter inputs from a sensing Foley catheter 2602. The sensing Foley catheter is present in the patient's bladder 2604 and includes a retention balloon 2608 and a pressure sensing balloon 2610. The sensing Foley catheter may include other sensors as disclosed herein.

[0163] The sensing Foley catheter 2602 includes a retention balloon inflation lumen, a pressure balloon sensing lumen, and a urine lumen. The pressure sensing balloon 2610 is connected to a pressure sensing lumen that is connected to a pressure transducer 2620 that may be incorporated into the control unit 2628. The urine lumen is connected to a urine output tube 2612. The urine output tube may be connected to a urine volume measuring device 2616 or may be output to and emptied into a urine reservoir 2614 that may be incorporated into the control unit as disclosed herein. Additionally, the urine volume may be controlled by a urine pump 2618 that may be disposed on the urine drainage tube, may be incorporated into the control unit, or may be disposed on the non-patient side of the control unit as disclosed elsewhere herein.

[0164] This patient is shown to be equipped with a respirator mask 2622 supplied by a respirator tube 2624. The flow and nature of the respiratory gas are controlled by a respirator 2626.

[0165] The loop control unit 2628 is connected to the urine volume measuring device 2616, the urine pump 2618, the pressure transducer 2620, and the respirator 2626 via connectors 2630, 2632, 2634, and 2636, respectively. The connectors may be wired or wireless. Alternatively, in this and other embodiments, some or all of the urine volume measuring device 2616, the urine pump 2618, and / or the pressure transducer 2620 may be incorporated into the control unit 2628.

[0166] In this example, the loop control unit 2628 can receive patient parameter inputs from the urine volume measurement device 2616 and the pressure transducer 2620, and use the information provided by these parameters to control the urine pump 2618 and the respirator 2626. Some of the parameters that the loop control unit can receive from the sensing Foley catheter include IAP, respiratory rate, heart rate, cardiac output, tissue oxygenation, tissue perfusion pressure, body temperature, urine analyte, urine output rate, and other parameters including those disclosed herein.

[0167] For example, when the loop control unit receives parameter information indicating that the patient's IAP is rising, the loop control unit can control the perfusion rate, pressure, or other parameters of the respirator. The loop control unit can capture data from one or more input parameters and control one or more treatment medical devices. For example, based on the received elevated IAP and abnormal tissue oxygenation parameters, the loop control unit may control the output of the respirator 2626 and also control the urine output rate by controlling the urine pump 2618.

[0168] The loop control unit continues to monitor one or more patient parameters and adjusts one or more treatment medical devices accordingly. When the patient parameters normalize, the control of the treatment medical device is adjusted accordingly, whereby the feedback loop controlled by the loop control unit becomes a closed loop. It is also possible to manually adjust the loop as needed, in which case the loop becomes an open loop or a semi-closed loop.

[0169] FIG. 27 shows another example of the loop control unit in a patient environment. In this example, the patient has an intravenous (IV) line 2702 in a blood vessel of the arm. The IV fluid bag 2704 is raised so that the IV fluid drips and / or flows into the patient via the IV line 2702. The valve 2706 controls the flow rate of the IV fluid to the patient by allowing the fluid to flow freely, restricting the flow, or stopping the flow. Here, the valve 2706 is controlled by the loop control unit 2628 via the connection part 2708. The IV fluid bag 2704 can contain a hydrating fluid and / or a drug. One or more IV bags can be involved, and one or more valves can control the IV bag(s). The loop control unit can control the flow rate and components of the intravenous drip(s) to the patient based on the patient parameters received by the loop control unit.

[0170] FIG. 28 shows another example of the loop control unit in a patient environment. In this example, the patient has inserted a fluid drainage line 2802 into the abdomen. The fluid from the abdomen may flow from the patient to the receptacle 2804. The flow of the fluid may be controlled by a pump 2806 that is controlled by the loop control unit 2628 via the connection part 2808. The loop control unit may control the flow of the fluid from the patient to the receptacle 2804 via the pump 2806 based on the received patient parameters. For example, when the IAP is abnormally high, the loop control unit can increase or initiate the rate of fluid removal from the patient by controlling the pump 2806.

[0171] Figure 29 shows another example of the loop control unit in a patient environment. In this example, the patient has an intravenous (IV) line 2902 in the blood vessel of the arm. The drug infusion device 2904 controls the flow rate of the drug to be infused into the patient via the intravenous line 2902. Multiple drug infusion devices can also be used. Here, the drug infusion device 2904 is controlled by the loop control unit 2628 via the connection part 2906. The drug infusion device 2904 can contain at least one of any appropriate fluid and drug. The loop control unit can control the flow rate and components of one or more drugs to the patient based on the patient parameters received by the loop control unit.

[0172] These examples show a part of the medical treatment device that can be controlled by the loop control unit, but any medical treatment device can be used.

[0173] Figure 30 is a detailed diagram showing the loop control unit. The loop control unit 2628 can receive one or more patient parameter inputs from a sensing Foley catheter or other devices. These inputs include, but are not limited to, urine volume and urine rate, pressure profile from the bladder, and sensor information from devices such as a sensing Foley catheter. The pressure profile information from the bladder can be further analyzed to measure IAP, respiratory rate, heart rate, cardiac output, sepsis index, acute kidney injury index (AKI), and other patient parameters. This analysis may be performed in the loop control unit 2628 or in a separate control unit connected to the loop control unit by either a wired or wireless connection. The connection may be via a network such as the Internet, intranet, WAN, LAN, etc., or may be a local one via Bluetooth (registered trademark), Wi-Fi, etc.

[0174] The loop control unit receives one or more inputs, analyzes the data, and determines whether it is necessary to change the control of the medical treatment device. One or more medical treatment devices may be controlled to bring the patient parameters within the target range. Once the patient's target range is achieved, the loop control unit can return the one or more controlled medical treatment devices to their standard state. The standard state will vary for each medical device and also for each patient. Similarly, the target range of patient parameters will vary for each patient and depending on the patient's condition. For example, the respiratory rate target range of a respirator may vary depending on whether the patient is in a sedated state or not.

[0175] In addition, in the embodiments of the present technology, the intravenous infusion or drug injection rate can also be automatically adjusted based on the feedback from the detected cardiac output or respiratory rate. In such an embodiment, when the respiratory rate drops too low, the patient-controlled analgesia pump can be stopped. Respiratory depression can be fatal in this group, and this protective measure can prevent overdose. The automated feedback system is also advantageous in large-volume resuscitation procedures, adjusting the infusion based on the intra-abdominal pressure, issuing a warning when the intra-abdominal pressure rises, and slowing down the infusion rate to prevent abdominal compartment syndrome. Yet another automated feedback function can provide direct feedback to the ventilator system so that the ventilation gas reaches the optimal pressure. When the abdominal pressure rises, a general ventilator setting may not be able to provide sufficient respiration for the patient. The automatic adjustment of the ventilator setting based on the intra-abdominal pressure feedback from this embodiment can advantageously provide optimal patient ventilation. Also, the embodiments of the present technology can be applied as corrections in the application and understanding of other diagnostic measurements. For example, when the intra-abdominal pressure rises, the central venous pressure may be significantly distorted. By enabling the central venous pressure reporting system to directly access these data, this critical physiological parameter can be automatically corrected and accurately reported. Also, the embodiments of the present technology can be used in various other ways to automate treatments such as injecting a fluid further containing an active agent such as a vasopressor or a diuretic in response to an increase or decrease in cardiac output and other parameters.

[0176] Other inputs and outputs to the loop control unit include nutrition supplied from a nutrition tube or vein, wound drainage, defecation, thoracic drainage, sweating, and the discharge of exhaled vapor. The evaluation of sweating may be performed by measuring body temperature, ambient temperature, and ambient humidity, or in the case of a ventilated patient, by measuring the inspiratory temperature and inspiratory humidity. Alternatively, or in addition, a skin sweating sensor may be used.

[0177] In addition to directly controlling one or more medical treatment devices, the loop control unit 2628 can also sound alarms including audible alarms, email alarms, text alarms, pager alarms, etc. The loop control unit 2628 can also provide outputs to other systems for system integration, such as outputting information to an electronic health record (EHR) or other data archive system, or other systems. The loop control unit 2628 can also receive inputs from various EHRs, EMRs, or other systems.

[0178] As a result of the data collected and / or analyzed by the sensing Foley catheter system, a medical treatment may be administered to the patient. This treatment may be a drug automatically administered via the loop control unit, or may be manually administered via conventional drug methods, i.e., orally, by injection, etc.

[0179] Also, based on the results of the sensing Foley catheter system, further medical diagnoses may be made.

[0180] Specific gravity

[0181] Urine specific gravity can be measured by pressure measurement and ultrasonic measurement using a sensing Foley catheter. Figure 34 is a plot showing how the ultrasonic and pressure volume measurements diverge depending on the liquid concentration. The liquid to be measured is concentrated synthetic urine and the specific gravity is approximately 1.100.

[0182] For a liquid with a specific gravity of 1.000, the two measurement techniques are calibrated to provide the same volume measurement. However, as the concentration increases, the two begin to diverge. For pressure, since V = A*h, P = ρ*g*h, i.e., V = A*ρ*g / P, the volume measurement increases as the concentration increases. In the case of ultrasonic, since V = A*h, v = h*2 / t, and v = (E / ρ)^(1 / 2), then V = A*(E / ρ)^(1 / 2)*t / 2, so the volume measurement decreases with an increase in concentration. V: Volume A: Cross-sectional area h: Liquid height P: Pressure ρ: Liquid concentration g: Gravity v: Sound velocity t: Time for sound reflection E: Bulk modulus of the liquid

[0183] Briefly stated, when the liquid concentration increases, the pressure increases and its measured value becomes highly biased. At the same time, the sound propagation speed becomes faster and the measured value of the ultrasonic wave becomes low and distorted. By measuring how much deviation there is, the liquid concentration can be measured. This is on the premise that the temperature does not change, but it is also possible to monitor the temperature and correct for temperature fluctuations. The detection Foley catheter can perform volume measurement by ultrasonic waves and pressure, as well as body temperature measurement. In this way, by combining the detection Foley catheter and the control unit, the urine specific gravity can be measured.

[0184] Detection / judgment of specific conditions

[0185] Figure 31A is a table listing multiple combinations of multiple parameters that enable fingerprints or signatures (one combination of multiple parameters) for different indicators of AKI (prerenal, intrinsic, and obstructive). In addition, there may be fingerprints or signatures regarding the timing of parameter changes, by which the cause of AKI can also be identified (for example, it is most likely that in intrinsic AKI due to glomerulonephritis and intrinsic AKI due to acute tubular necrosis, the changes in some parameters are faster). Also, since effective treatment methods vary depending on the cause of AKI (for example, recombinant alkaline phosphatase is effective for intrinsic (septic) AKI but not for non-septic AKI), this multi-parameter approach can facilitate the selection of an effective treatment method for the treatment of AKI.

[0186] Figure 31B is a table listing multiple combinations of multiple parameters that enable fingerprints or signatures (one combination of multiple parameters) for different indicators of sepsis, AKI, and acute respiratory distress syndrome (ARDS). These signatures are accompanied by increases, decreases, or both in various patient parameters such as urine output, heart rate, respiratory rate, body temperature, cardiac output, abdominal perfusion pressure, etc. Abdominal perfusion pressure is the difference between mean arterial pressure (MAP) and intra-abdominal pressure (IAP). Mean arterial pressure is diastolic pressure (DP) plus one-third of pulse pressure (PP). (Pulse pressure is the difference between systolic pressure and diastolic pressure). That is, MAP = DP + 1 / 3PP.

[0187] Also, other patient parameters may be used. One, several, or all relevant parameters can be used by the control unit to communicate the diagnosis and / or risk to the user or other devices. Patient parameters obtained by the sensing Foley catheter system can be used alone or in combination with parameters obtained elsewhere, such as an electrocardiogram, a blood pressure measuring device, information from an EMR.

[0188] The sensing Foley catheter system can automatically and accurately monitor physiological parameters in real time to detect various medical conditions early. By applying real-time multivariate analysis (point values) and time-series analysis (trends) of these high-frequency data streams to machine learning-based models, highly sensitive physiological signatures for early detection of sepsis onset (or other medical condition determination) can be developed. This enables earlier diagnosis and intervention, improving clinical outcomes. Signatures related to data on physiological changes occurring before and / or during the onset of a specific medical condition can be continuously improved by strengthening relevant parameters, weakening less relevant parameters, and constructing or breaking connections through machine learning via an artificial neural network. This allows the control unit to utilize algorithms that distinguish between medical conditions and between normal and other pathological states.

[0189] Some embodiments of the present invention can measure urine volume immediately after a patient is administered a diuretic. This type of test can be a powerful indicator of whether a patient with AKI will progress to a more severe stage and / or die. If the patient's urine volume increases after diuretic administration, it indicates that the likelihood of AKI worsening is low. If the patient's urine volume does not increase significantly even after diuretic administration, it indicates that the progression of AKI is likely advanced. The present invention can measure urine volume quickly and accurately in real time. Therefore, the response to a diuretic can be detected more quickly (in minutes rather than hours) than with conventional urine measurement methods.

[0190] This test can be automated with a control unit that controls the dosage of the diuretic and subsequently monitors urine volume for several minutes to several hours, preferably only for a few minutes. The diuretic administered may be furosemide, or other suitable loop diuretics or other diuretics. The diuretic is administered as disclosed in Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Tumlin JA, Shaw AD, Trevino S, Kimmel PL, Seneff MG. Development and standardisation of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207, and data can be collected. This document is hereby incorporated by reference in its entirety.

[0191] In addition to detecting AKI, the present invention can detect urinary tract infection (UTI) using as indicators the relatively stable oxygen partial pressure, decrease in carbon dioxide concentration, increase in specific gravity, and urine volume and conductance. Detection of UTI is possible with or without AKI by combining urinary markers for the fingerprint of UTI. The fingerprint of UTI can alert clinicians to the presence of UTI.

[0192] In addition to the detection of AKI and UTI using the above-described parameters, these parameters can be used in combination with measurements of intra-abdominal pressure (IAP), respiratory rate (RR), heart rate (HR), cardiac output (CO), relative stroke volume (RSV), body temperature (Temp), pulse pressure (PP), urinary conductivity (UC), urine output (UO), and / or stroke volume (SV), which are measurements that have already been used for the detection of increased intra-abdominal pressure (IAH), abdominal compartment syndrome (ACS), and sepsis, etc. By adding the measurements of IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, and / or SV to the algorithms described herein, the sensitivity and specificity for detecting AKI or UTI can be improved. On the other hand, by adding the measurements obtained according to the present invention to the measurement algorithms of IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, and / or SV, the sensitivity and specificity for detecting IAH, ACS, or sepsis can be improved. In addition, it is also clinically applied to the treatment of trauma and burns, etc.

[0193] In addition to the absolute measurement of IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, gas concentration, and / or SV, the trend data of these parameters can also be used for the detection of IAH, ACS, sepsis, or other symptoms. For example, the slope of the values of these parameters over time and / or the variation of the values of these parameters over time can also be used. Also, as an example of utilizing the trend of data, the use of pulse pressure waveform analysis and pulse wave velocity (or pulse transit time) can be mentioned. The pulse transit time can be measured by capturing an electrocardiogram signal such as an electrocardiogram from a lead wire on a detection Foley catheter and / or other locations and measuring the time it takes for the pressure signal of the pulse wave to transition to the bladder. In order to determine the presence or absence of symptoms such as IAH, ACS, sepsis, etc., a plurality of parameters and / or the trends of the parameters can be used.

[0194] Examples of the utilization of trend data include the following.

[0195] - If UO is decreased while vital signs are stable (otherwise), there may be a possibility of acute kidney injury. If cardiac output is decreased, the kidneys may be ischemic. If urine output suddenly increases while vital signs are stable, there may be a possibility of toxic acute kidney injury.

[0196] - If the respiratory rate increases and cardiac output decreases, it may indicate pulmonary embolism, hemorrhage, or other volume depletion.

[0197] An increase in the respiratory rate while vital signs are stable may indicate impending airway obstruction.

[0198] - If the respiratory rate decreases while other parameters are stable, it may indicate over - administration of sedatives. This is a major issue in the analgesic control of patients.

[0199] - An increase in intra - abdominal pressure (IAP) in a state where cardiac output is stable and urine output is increasing can be an indicator of impending fluid overload.

[0200] - An increase in IAP in a state of decreased UO and decreased cardiac output can be an indicator of cardiopulmonary insufficiency. This may be due to fluid overload, sepsis, etc.

[0201] The present invention can be used in various hospital environments (e.g., emergency rooms, operating rooms, intensive care units, hospital wards). At any time, the device can be used to check the progression of AKI, and the presence or absence of improvement or decrease. Its algorithm functions to warn clinicians of newly developed AKI cases or changes in the state of AKI. It is also possible to detect the onset of AKI by providing the device before kidney damage occurs (e.g., detecting whether a patient undergoing heart surgery is starting to suffer kidney damage during the operation). This may also be provided to detect the degree of damage at that time if kidney damage has already occurred. In addition, this device can also be used to monitor the response to treatment / treatment intervention (e.g., renal replacement therapy, infusion resuscitation).

[0202] Alternative embodiments

[0203] In addition, embodiments of the present technology can report a patient's movement in the detection or diagnosis of episodic diseases. In this embodiment, pressure fluctuations can trigger an EEG or recording device to enable monitoring during intense periods between the onset of symptoms suspected of being seizures. Additionally, or alternatively, pressure sensors, acoustic sensors, or other sensors can be used to detect intestinal activity including peristaltic movement, patient movement, seizure activity, patient tremors, cough frequency, cough severity, sleep time, sleep quality, voice detection, patient compliance (movement or lack thereof), and can warn medical staff that the patient must be turned over because they are not moving. Information related to this movement may be relayed to a hypothermia device, a drug delivery device, or other devices that control or reduce seizure activity, tremors, and / or coughs.

[0204] In some embodiments, the sensing Foley catheter is configured to report the presence of water droplets or other obstructions within a lumen (such as a pressure lumen) filled with air and subsequently process or resolve the water droplets. In particular, in a hypothermic environment, moisture in the air lumen may condense and form obstructive water droplets. Water droplets within an air-filled lumen (or air bubbles within a water-filled lumen) can disrupt or complicate the pressure signal due to the surface tension of water. Thus, the pressure transmission lumen in some embodiments of the disclosed technology may include a hydrophilic function (such as a coating on the wall of the lumen itself or hydrophilic fibers extending the length of the lumen) to draw moisture out of the lumen to maintain a continuous and unbroken air channel. In some embodiments, a hygroscopic composition (such as silica gel) can be used along the air injection line or within the air injection lumen itself to capture water or humidity. In some embodiments, the hygroscopic composition can be included within the catheter so that there is no need to service the air injection circuit to replace this material.

[0205] In some embodiments of the disclosed technology, as described in more detail above, air can also be intermittently (and automatically) injected into and extracted from the pressure sensing balloon so that the balloon is in a certain optimally primed state. Also, when the lumen is provided with wicking fibers or a hydrophilic coating, air venting can contribute to removing and capturing moisture from the air line. In the example of a liquid-filled lumen, applying hydrophilic fibers or a hydrophilic coating inside the pressure lumen has a similar advantage in that the lumen can then handle air bubbles. At this time, although the signal may be disrupted if there are air bubbles, applying a hydrophilic coating to the lumen of the catheter relaxes the surface tension at the air-water interface.

[0206] In addition, in the case of lumens filled with liquid and / or air, custom extrusion and lumen shapes can also be used to prevent blockage. In some embodiments of the present technology, for example, a Foley-type catheter can have a lumen with a star-shaped cross-sectional shape. Such lumens generally avoid blockage by water droplets because the water droplets tend to cling to themselves and be washed away from the hydrophobic walls. This behavior tends to leave the cross-sectional space unfilled, and the air channels around the water droplets can be patented and transmitted to the sensor. The same rationale applies to air bubbles in a hydrophilic star-shaped water lumen. In this case, the hydrophilic liquid adheres to the walls, and a column of water that excludes air bubbles becomes continuous up to the center of the lumen. The same is true when there is a hydrophobic liquid in a hydrophobic lumen. In some embodiments, the catheter includes an air channel and a sensor incorporated within the catheter itself or within a fluid lumen, and the fluid lumen can transmit pressure back to the sensor.

[0207] The drainage tube may be a multi-lumen tube for accommodating a urine drainage line, a pressure lumen, and thermocouple wiring, with one end connected to a barb and the other end connected to a control unit.

[0208] The Foley catheter can be extruded or have an X-ray opaque marker attached for fluoroscopic observation. 4

[0209] The thermistor at the tip of the catheter can be fixed in place using multiple extrusion profiles and assembly techniques.

[0210] In some embodiments, the sensing Foley catheter may include a blood pressure sensing element that can take any of several forms. In one embodiment, the blood pressure sensing element includes a pressure delivery balloon (a balloon in fluid communication with another dedicated balloon or device holding balloon or pressure sensing balloon) that can be optically analyzed when inflated to determine at what pressure the blood vessels within the bladder or urethra branch and blood flow stops. In this way, the perfusion pressure of the tissue in contact with the pressure delivery balloon can be measured, and this measurement reflects both systemic blood pressure and vascular resistance. The perfusion pressure device of this embodiment can be used to detect or monitor various acute or critical medical conditions such as sepsis, shock, hemorrhage, etc. early, and can be particularly advantageous in detecting these symptoms early. When predicting sepsis, embodiments of the present invention can receive white blood cell count information and may be able to more appropriately predict sepsis.

[0211] Other modalities can also be used to detect tissue whitening or ischemia, and a common methodological aspect is to intermittently expand within a lumen, body cavity, or body tissue to compress the vasculature. Embodiments of this device and associated methods can also be used to detect perfusion pressure at other sites of the body by an intermittently expanding member and optical detection of the presence of blood flow or blood.

[0212] Tissue perfusion information may be provided by sensors disposed on the catheter shaft such that they contact the urethral wall when the catheter is in a predetermined position. These sensing techniques can include microdialysis, pyruvic acid, lactic acid, pO 2 , pCO 2 , pH, perfusion index, near-infrared spectroscopy, laser Doppler flowmetry, urethral capnography, and orthogonal polarization spectroscopy, etc. These tests can also be performed on urine and the bladder wall itself to measure tissue perfusion.

[0213] The detection Foley catheter system according to another example includes a cleaning mechanism according to one embodiment that includes an apparatus and / or port for positive air flow near the starting point of the drainage line. By actively pumping air, urine is forced to flow into the drainage line, promoting drainage. The positive pressure air flow device may include a one-way valve at the tip of the urinary catheter that allows urine to flow only towards the urine collection device and prevents air from entering the catheter.

[0214] In some embodiments, the urine cleaning mechanism is configured to include a coating inside the urine drainage tube for reducing surface tension and promoting drainage. In one aspect, the coating is a hydrophobic polymer including, but not limited to, PTFE or FEP.

[0215] Also, relative cardiac output and relative minute ventilation can be calculated based on the displacement of at least one of a pressure sensor and a force meter. By sampling at a sufficient frequency (e.g., 1 Hz or higher), it is possible to relatively quantify the amplitude of the respiratory excursion during catheter placement. Large movements are generally related to heavier breathing or higher peritoneal pressure when the baseline fluctuates upward. By using a faster sampling rate (e.g., 5 Hz or higher), small peaks on the oscillatory respiratory wave due to the pumping action of the heart can also be tracked, and the amplitude of this wave can measure relative cardiac output at a relatively constant peritoneal pressure setting and absolute cardiac output and / or cardiac output at a well-known stable peritoneal pressure setting.

[0216] The intra-abdominal pressure or bladder pressure detected by one embodiment of the disclosed technology can also be used to detect the level of a patient's movement (e.g., which can vary from a state of substantially no movement to a state of high movement level) and report the movement level to a healthcare provider. The occurrence of peaks and valleys of bladder pressure activity in a short time is a strong indicator that the bladder pressure profile indicates, for example, that the patient is using abdominal muscles to lift the body or get out of bed, and can function as a proxy for body movement. This embodiment is particularly beneficial for patients at risk of falling. In the case of patients at risk of falling, healthcare providers can be notified that the patient is lifting the upper body and can respond accordingly. Alternatively, the device can also be used to report the patient's inactivity and / or lack of movement of the patient.

[0217] The pulse oximetry element can measure blood oxygen concentration and saturation and can be placed at any location along the urethral length of the catheter. In some embodiments, one or more sensors are placed within the tube of the device to ensure proximity to the urethral mucosa. With this technique, healthcare providers can decompress the bladder with a urethral catheter and accurately obtain reproducible pulse oximetry data. The power source for pulse oximetry may be built into the urine collection container or 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 attached to the disposable catheter and removed when oxygen measurement is no longer desired. Embodiments of the sensing Foley catheter may include optically transparent or sufficiently transparent channels for pulse oximetry signals, such as optical fiber cables, transparent windows, and interfaces for reusable oximeters. This method and apparatus for urethral pulse oximetry may be used in combination with any of the other embodiments detailed herein or may be an independent device.

[0218] For infection prevention, an antibacterial coating or a material impregnated with an antibacterial compound may be used on the detection Foley catheter. Examples of antibacterial coatings / materials include silver, silver citrate, parylene, or any other suitable material.

[0219] Also, pulmonary blood volume fluctuations can be measured with a detection Foley catheter system to assist in evaluating the presence and risk of heart failure. A decrease in left ventricular function can lead to an increase in pulmonary blood volume (PBV) and a decrease in pulmonary blood volume fluctuations. PBV fluctuations are defined as the change in PBV over time during the cardiac cycle. PBV can be measured as the product of cardiac output and pulmonary transit time (PTT). Cardiac output can be measured as the product of stroke volume and heart rate, and stroke volume is the area under the flow-time curve during one cardiac cycle. Pulse transit time can be obtained by looking at the delay between the QRS complex of the electrocardiogram and the appearance of the signal in the bladder. The electrocardiogram signal can be obtained from another electrocardiogram lead, a lead incorporated into the detection Foley catheter, a lead incorporated into the catheter insertion kit, or others. Also, the electrocardiogram lead can read the electrocardiogram signal from anywhere in the urine. By using two lead wires, the pulse transit time can be measured more accurately.

[0220] After myocardial infarction, it has been found that cardiac output, ejection fraction, and PBV fluctuations decrease, and PBV fluctuations change the most significantly. Therefore, measuring the fluctuations in PBV and identifying a decrease in the fluctuations in PBV can be a strong sign of heart failure or a high risk of heart failure.

[0221] Data collected by the detection Foley catheter system is stored in a database and can be used for trend analysis and the like. The data may include clinical data and / or device data. For example, data can be collected from multiple patients, anonymized and aggregated, and used for predicting better treatment, monitoring, or behavior of future patients. For example, the control unit can aggregate and analyze data collected over time regarding heart rate, respiratory rate, body temperature, infectious diseases, etc., and find trends such as the relationship between various parameters and results. For example, certain trends in body temperature can be predictive factors for infection, onset of sepsis, ARDS, and / or AKI, either alone or in combination with other parameters. FIG. 31 shows a well-known example, but there may be other, currently unknown trends emerging from the aggregated patient data.

[0222] Data collected by the detection Foley catheter system may be integrated with the lifetime electronic health record (EHR), electronic medical record (EMR), and / or other systems. Data collected by the control unit of the detection Foley catheter system can directly or indirectly serve as an interface with the EMR / EHR system. Data such as patient demographic data and medical history data from the EMR / EHR can also be integrated with the detection Foley catheter system.

[0223] Example of a data processing system

[0224] FIG. 33 is a block diagram showing a data processing system that can be used in any embodiment of the present invention. For example, system 3300 may be used as part of a control unit, as shown in some embodiments herein. FIG. 33 shows various components of a computer system, but it should be noted that it is not intended to represent a specific architecture or manner of interconnecting the components; such details are not relevant to the present invention. Also, it will be understood that network computers, handheld computers, mobile devices, tablets, mobile phones, and other data processing systems having fewer or perhaps more components may also be used in combination with the present invention.

[0225] As shown in FIG. 33, a computer system 3300, which is one form of a data processing system, includes one or more microprocessors 3303 and a bus or interconnect 3302 coupled to ROM 3307, volatile RAM 3305, and non-volatile memory 3306. The microprocessor 3303 is coupled to a cache memory 3304. The bus 3302 interconnects these various components and also interconnects these components 3303, 3307, 3305, and 3306 to a display control unit and display device 3308 and an input / output (I / O) device 3310, which may be a mouse, keyboard, modem, network interface, printer, and other devices well known in the art.

[0226] Typically, the input / output device 3310 is coupled to the system via an input / output control unit 3309. The volatile RAM 3305 is typically implemented as dynamic RAM (DRAM) that requires continuous power to refresh or maintain data in the memory. The non-volatile memory 3306 is typically a type of storage device such as a magnetic hard disk, magneto-optical drive, optical drive, or DVD-RAM that maintains data even when the power is turned off. The non-volatile memory is generally random access memory, but this is not essential.

[0227] Figure 33 shows an aspect in which the non-volatile memory is a local device directly coupled to the remaining components within the data processing system. However, the present invention may utilize a non-volatile memory that is remote from the system; for example, a network storage device coupled to the data processing system via a network interface such as a modem or an Ethernet® interface. As is well known in the art, bus 3302 can include one or more buses connected to each other via various bridges, controllers, and / or adapters. In one embodiment, I / O control unit 3309 includes a USB adapter for controlling USB (Universal Serial Bus) peripherals. Alternatively, I / O control unit 3309 may include an IEEE-1394 adapter, also called a FireWire® adapter, for controlling FireWire® devices.

[0228] Part of the detailed description above has been 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, as used herein, is generally considered to be a self-consistent sequence of acts leading to a desired result. An act is something that requires physical manipulation of physical quantities.

[0229] However, it should be borne in mind that all of these terms and similar terms are to be associated with appropriate physical quantities and are nothing more than convenient labels applied to these physical quantities. As is apparent from the above discussion, unless otherwise specified, throughout this specification, the discussion using terms as set forth in the claims refers to the operation and transformation of data represented as physical (electronic) quantities in the registers and memories of a computer system into other data similarly represented as physical quantities in the memory or registers of the computer system or in other such information storage, transmission, or display devices.

[0230] The illustrated technology can be implemented using code and data stored in and executed by one or more electronic devices. Such electronic devices can store code and data using 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 - carrier waves, infrared signals, digital signals, etc.) and can communicate (with other electronic devices internal and / or on a network).

[0231] The processes or methods depicted in the previous drawings may be executed by processing logic consisting of 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 have been described from the perspective of several consecutive operations, it should be understood that some of the described operations may be executed in a different order. Furthermore, some operations may be performed in parallel rather than sequentially.

[0232] Unless otherwise defined, all technical terms used in this specification have the same meaning as commonly understood by those skilled in the medical field. Specific methods, devices, and materials are described in this application, but any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. Embodiments of the present invention have been described with some details and figures, but such figures are for the sole purpose of clarifying understanding and are not intended to be limiting. In this specification, various terms are used to convey the understanding of the present invention, but it should be understood that the meanings of these various terms extend to their general linguistic or grammatical variations. Furthermore, some theoretical considerations have been advanced to provide an understanding of the technology, but the appended claims of the present invention are not bound by such theories. Additionally, any one or more features of any embodiment of the present invention can be combined with any one or more other features of any other embodiment of the present invention without departing from the scope of the present invention. Still further, it should be understood that the present invention is not limited to the embodiments shown for illustrative purposes and is defined only by a fair reading of the appended claims in the patent application, which includes the full scope of equivalency to which each element is entitled.

[0233] Some embodiments of the detection Foley catheter system include using ultraviolet light, or light of an appropriate wavelength, to sterilize the collection chamber itself or other components of the system. The ultraviolet light source may irradiate ultraviolet light through the wall of the collection chamber, or alternatively, the ultraviolet light source may be disposed inside the collection chamber. The ultraviolet light source can be used to sterilize the collection chamber when the collection chamber is empty, full, or partially full. The ultraviolet light source can be used to sterilize when urine enters the collection chamber. The ultraviolet sterilization may be performed continuously or intermittently. The ultraviolet light source may be disposed at any location of the detection Foley catheter system. Inside the bladder, ultraviolet light, or light of other wavelengths, can be used.

[0234] Spectroscopy - Spectrophotometer

[0235] Some embodiments of the Foley catheter system for detection involve using light wavelengths in the range of about 520 nm to about 650 nm to distinguish bacteria, red blood cells, and / or plasma / white blood cells. Refer to the area inside the ellipse in FIG. 34.

[0236] Some embodiments of the Foley catheter system for detection involve combining a spectrophotometer for distinguishing white blood cells and bacteria in combination with distinguishing a decrease in pO 2 and / or an increase in CO 2 to identify infection.

[0237] Some embodiments of the Foley catheter system for detection involve the control unit filtering urine volume data to compensate for the increase in urine volume immediately after administration of a diuretic. Generally, urine volume increases immediately after administration of a diuretic. However, under certain circumstances, it is beneficial to substantially ignore the increased urine volume data associated with the administration of a diuretic. The control unit of the Foley catheter system for detection can automatically ignore the urine volume data associated with the administration of a diuretic by identifying the shape of the urine volume curve associated with the administration of the diuretic and subtracting and / or ignoring the data associated with this increase. Identification of the shape of the curve can be performed based on slope, length of increase, amplitude of increase, shape, etc. Subtraction of urine volume data by a diuretic can be effective in determining and predicting the onset of AKI. Refer to FIG. 35. For example, when the urine volume rises significantly above about 2,000 ml / h (peak), the control unit can recognize that a diuretic has been administered.

[0238] The increase in urine volume due to the administration of a diuretic can be distinguished from the increase in urine volume caused by blocking, such as clamping of the urine drainage tube and / or Foley catheter. In a situation where the drainage lumen is clamped, the urine volume before the increase is substantially zero, or very small, for example, less than 5 ml / hour. In contrast, in a situation where a diuretic is administered, the urine volume immediately before the administration of the diuretic is very small, but is probably greater than zero, for example, greater than about 5 ml / hour. In addition, in a situation where the drainage lumen is clamped, the increase in urine volume after the clamp of the drainage lumen is released is for a relatively short time, for example, between about 30 seconds and about 5 minutes. In contrast, in a situation where a diuretic is administered, the increase in urine volume is for a longer time, for example, between about 30 minutes and about 2 hours. In addition, in a situation where the drainage lumen is clamped, the urine volume after the clamp of the drainage lumen is released is likely to be less than 1000 ml. In contrast, in a situation where a diuretic is administered, the urine volume after the administration of the diuretic is likely to be greater than 1000 ml. The control unit may use any or all of these factors to analyze the urine volume curve over time, determine the time when the diuretic is administered, and subtract the increase in urine volume due to the diuretic from the urine volume presented to the user.

[0239] In this way, the control unit can also automatically determine the timing of administering the diuretic. Alternatively, the user interface of the control unit may include a button or other user input device (touch screen, voice control, etc.) indicating that the diuretic has been administered. Subsequently, the control unit will look for an increase in urine volume and subtract the increase in urine volume due to the diuretic from the urine volume data presented to the user.

[0240] Some embodiments of the detection Foley catheter system include the control unit measuring the abdominal perfusion pressure (APP). APP is defined as the difference between the mean arterial pressure and the intra-abdominal pressure (IAP). The mean arterial pressure can be measured by conventional methods and APP can be measured in combination with the measurement of IAP by the control unit. The control unit can further automatically change the infusion of fluids and / or vasopressors / vasoconstrictors to increase or decrease blood pressure.

[0241] Also, in the embodiment shown in FIG. 36, wetting of the vent / filter can also be prevented. This embodiment includes a lumen that connects to the drainage lumen 3604 near the barb region 3606 and is vented to the atmosphere or other air / gas / fluid through one or more filters / vents 3608 along the vent tube and / or near the other end. The filter / vent may be within the collection container as shown in FIG. 36 or at a location separate from the collection container.

[0242] The vent lumen may be incorporated into the drainage lumen either alongside the urine drainage lumen or within the urine drainage lumen. Alternatively, the vent lumen may be connected to the drainage lumen near the junction of the vent tube and the drainage tube, for example, near the barb region 3606, separate from the drainage lumen.

[0243] Any embodiment herein may include physiological pressure measurement or may be used without performing physiological pressure measurement. For example, the system can also be used with a standard Foley catheter without including a thermistor or pressure lumen.

[0244] In one embodiment, the pressure can be measured at the junction of the positive pressure tube and the drainage tube. Alternatively, the pressure may be measured at the junction of the sensing Foley catheter and the drainage tube, or in the region of the valve. By incorporating an additional tube or lumen that is in fluid communication with the junction of the pressure tube and the drainage tube, or the region of the valve at one end and in fluid communication with a pressure sensor or transducer at the other end, the pressure can be measured at any of these locations. For example, this pressure measurement lumen may be in fluid communication with a control unit that houses the pressure sensor at one end (sensor side) and in fluid communication with the junction of the positive pressure tube and the drainage tube at the other end (detection side). A pressure-sensitive membrane may be provided on the detection side to prevent contamination of the lumen by urine.

[0245] By further detecting an air lock, the air lock can be optimally eliminated and / or avoided. Using any of the embodiments herein, the control unit can apply a slight positive or negative pressure to the urine drainage lumen and detect its response. Since air is more compressible than urine, a dull response indicates the presence of an air lock, and a non-dull response indicates fewer air locks. When an excessive air lock is detected, the control unit can initiate removal of the air lock, for example, by applying a negative pressure to the drainage lumen.

[0246] In some embodiments, the air lock may be detected using a flow meter(s) or flow sensor(s) incorporated into the system. For example, a flow meter may be added to the vent tube and / or near or within the cassette. When there is little or no current air flow in the vent tube, an air lock may be present in the urine drainage line. The drainage line may be pulled to a low vacuum to determine if there is flow in the vent tube, and if there is still no flow, since there is a high likelihood of an air lock, the elimination of the air lock may be initiated. Additionally or alternatively, a flow sensor may be provided within or near the cassette. When applying a vacuum to the drainage line, if there is no or little flow in the cassette or near the cassette, there may be an air lock. The level of flow may indicate near an occlusion based on the compliance of the system / drainage tube. For example, in the case of an occlusion by a clamp near the Foley catheter, when applying a vacuum, some flow occurs in the cassette, but when there is an air lock near the cassette, almost no flow is observed in the cassette when applying a vacuum.

[0247] In some embodiments, the valve may be provided anywhere within the system, including within the positive pressure tube or within the reservoir.

[0248] The vent tube may be a separate tube from the drainage tube and may be inserted into the drainage lumen or into the Foley catheter. FIG. 37 shows a detection Foley catheter system according to an embodiment where the vent tube is within the urine drainage tube. This type of embodiment has the advantage that it can be used with a common drainage tube. The vent tube basically places a vent anywhere within the drainage tube or within any drainage lumen within the Foley catheter. The vent tube is slidably inserted into the drainage tube and / or the Foley catheter and can be moved at any time.

[0249] In the embodiment shown in FIG. 37, the vent tube 3704 may be open at one end (the "air end" 3708) to the vent / filter 3702 (open to atmospheric pressure) in the collection reservoir and at the other end (the "urine end" 3710) within the urine drainage lumen 3706. Here, the vent tube is shown terminating within the barb at the base of the Foley catheter, but the vent tube can terminate anywhere within the urine drainage lumen including anywhere within the drainage tube or within the Foley catheter. The vent tube can be fastened in one place or moved within the system to maximize urine drainage and minimize air lock and bladder damage due to negative pressure within the bladder.

[0250] FIG. 38 shows an alternative sensing Foley catheter system in which the vent tube 3802 has a vent / filter 3804 at the "urine end" of the tube and is open to the atmosphere at the "air end" 3806 of the tube. Also, filters / vents may be provided at both ends. The "air end" of the vent tube can exit the drainage lumen in a Y-arm adapter, a cock plug, or other standard ways. The "air end" of the vent tube can exit the system from within the collection container via a channel or port incorporated into the collection container. Again, the vent tube can be used with any urine drainage tube including a standard urine drainage tube.

[0251] FIG. 39 shows an embodiment similar to that shown in FIG. 38 with a positive pressure tube 3902 added.

[0252] In any of the embodiments including any type of airlock elimination mechanism, the elimination of the airlock can be performed continuously, periodically (either at regular intervals or as needed), in response to a request, or when an airlock state is detected. The airlock elimination mechanism prevents or reduces the airlock. For example, the airlock elimination mechanism may reduce the airlock so as to eliminate the airlock at least every 60 minutes. Alternatively, the airlock may be eliminated at least every 45 minutes. Alternatively, the airlock may be eliminated at least every 30 minutes. Alternatively, the airlock may be eliminated at least every 20 minutes. Alternatively, the airlock may be eliminated at least every 10 minutes. Alternatively, the airlock may be eliminated at least every 5 minutes. Alternatively, the airlock may be eliminated at least every 1 minute.

[0253] In any of the embodiments including a vent or a filter or a vent tube as part of the barb region or the drainage tube, the drainage of the fluid (i.e., urine) may be discontinuous, i.e., interrupted, due to the gas / air introduced into the drainage lumen through the vent / filter / vent tube. That is, the drainage lumen may allow the liquid (i.e., urine) and the gas to flow alternately.

[0254] In any of the embodiments including real-time urine volume measurement, real-time may mean that the reported urine volume measurement is accurate within about 1 minute. Alternatively, real-time may mean that the reported urine volume measurement is accurate within about 5 minutes. Alternatively, real-time may mean that the reported urine volume measurement is accurate within about 10 minutes. Alternatively, real-time may mean that the reported urine volume measurement is accurate within about 20 minutes. Alternatively, real-time may mean that the reported urine volume measurement is accurate within about 30 minutes. Alternatively, real-time may mean that the reported urine volume measurement is accurate within about 60 minutes.

[0255] Air bubbles in urine - prevent air bubbles and / or prevent the influence on measurement.

[0256] Proteins and other components in urine may cause excessive foaming in the urine within the drainage lumen and / or collection container, which can lead to problems such as wetting of the vent / filter(s), urine flowing into the overflow area of the collection container, and inaccurate measurements. Some embodiments of the detection Foley catheter system incorporate an anti-foaming mechanism.

[0257] In some embodiments, such as those incorporating a positive pressure tube, the pressure within the urine drainage can be accurately controlled. It is also possible to apply a slight positive pressure intermittently within the drainage system (i.e., the drainage lumen and / or collection chamber) to break or prevent the generation of air bubbles.

[0258] A surfactant of a suitable material such as silicone, simethicone, etc. may be added to the system. For example, silicone capsules with a slow dissolution rate may be added to the collection reservoir. Alternatively, the surfactant may be applied to the inside of the drainage lumen and / or the inside of the collection container.

[0259] Alternatively, or in addition, a flat mesh portion can be inserted anywhere within the system, for example, at the junction of the drainage tube and the collection container.

[0260] In some embodiments, at least one of the cassette and the drainage lumen can be vibrated continuously or intermittently to break the air bubbles.

[0261] Figures 40A to 40C are diagrams showing embodiments incorporating floating or non-floating plates for compressing or decomposing bubbles on or near the surface of urine in a collection container. Plate 4002 may simply float on the surface and passively move up and down according to the amount of urine 4004 in the container, or the plate may be actively moved up and down. The plate may be fixed at a predetermined position. The plate may be porous or solid. In embodiments where the plate is on the liquid surface, the plate can also be used for urine volume measurement. The position of the plate can be identified by technologies such as ultrasonic waves, visual means (such as a camera), and lasers. The volume of the fluid in the collection container can be directly measured from the fluid level determined by the position of the plate.

[0262] The interior of the cassette may be rectangular or other shapes. For example, both sides of the interior of the cassette may taper inward towards the bottom so that there is a larger upper surface of urine relative to the volume of urine in the cassette. As a result, even a smaller amount of urine volume can be measured more accurately.

[0263] Some embodiments can include a volume measurement partition at a set volume mark, such as 50 ml for example. This volume measurement partition may be similar to partition 2002 shown in FIG. 20, except that it reaches a predetermined volume position. When the upper surface of the volume of urine in the cassette is at or near the position of the volume measurement partition, the ultrasonic signal becomes stronger than in other cases. For example, the volume measurement partition can be positioned such that when the upper surface of the urine volume reaches about 50 ml (or other set amount), the upper surface of the urine volume is at or near the position of the volume measurement partition. When the two surfaces (urine and volume measurement partition) approach or contact each other, the ultrasonic signal becomes the strongest.

[0264] Some embodiments may include a waveguide that helps account for the tilt of the reservoir. For example, an ultrasonic signal may be directed into a cylinder having a flat or curved surface, and the ultrasonic waves may be directed toward and reflected off the surface of the fluid within the reservoir. The waveguide may extend to all or part of the reservoir. The waveguide may extend between the ultrasonic transducer / sensor and the surface of the fluid.

[0265] In some embodiments, the ultrasonic transducer / sensor may be flat, and in some embodiments, the surface of the ultrasonic transducer / sensor may be curved, for example, in a convex curve. The convex curve helps to spread the ultrasonic signal over a greater number of angles, and helps to ensure that a portion of those angles are reflected from the liquid surface within the reservoir.

[0266] Some embodiments include a control unit that uses an accelerometer to measure the tilt of the reservoir, and then uses the tilt angle to calculate the volume of fluid remaining within the reservoir (i.e., at the lower corner of the reservoir) after the fluid has been emptied from the reservoir. This calculated remaining volume within the reservoir can be added to the calculation of the total urine volume to increase accuracy.

[0267] FIG. 41A shows a sensing Foley catheter system according to one embodiment that includes valves at both the drainage port 4102 and the inlet 4104 where the drainage tube connects to the collection container. This allows the control unit to periodically pressurize the collection container to assist with bubble reduction and / or drainage of the collection container. Also, this inlet port valve allows the control unit to stop the flow of urine into the collection container while the urine is being emptied, resulting in a more accurate measurement of urine volume.

[0268] In embodiments where the valve is active rather than passive (where "active" means being controlled by the control unit rather than the differential pressure between the valves), the control unit can calibrate the valve mechanism for each disposable unit, taking into account differences such as the thickness, hardness, diameter, material, etc. of the tubes. For example, a motor can be used to open and close an active valve such as the valve disclosed in this specification. A light gate can be used to evaluate that the tube in which the valve is operating is closed. The control unit can count the number of steps such as the number of rotation steps required to close a specific tube of a specific disposable part. This count can then be used when closing the same disposable part. This calibration can be performed when the disposable part is first attached to the control unit. Thereafter, calibration may be performed periodically or as needed on the same disposable part.

[0269] For example, when a new disposable part identified by an RFID tag or the like is used, the control unit rotates the valve motor once, and the light gate detects the maximum closure of the tube. The control unit counts the number of rotation steps until the tube is closed maximally. This number of motor rotation steps can be assumed to close the tube of the disposable part until the valve of the specific disposable part is calibrated next.

[0270] FIG. 41B is a diagram showing a collection container according to an embodiment in which the urine overflow path 4106 is longer and / or more complex and / or more tortuous and / or narrower. With this configuration, it becomes difficult for air bubbles to flow into the overflow path, and the measurement of the urine volume becomes inaccurate. The overflow path may include one or more path angles greater than 45 degrees.

[0271] Figure 41C shows a collection container according to one embodiment, where the fluid path (indicated by the dashed arrow) between the urine in the reservoir and the cassette pump interface 1148 is long and tortuous to prevent wetting of the interface 1148. The cassette pump interface 1148 may include a gas-permeable, liquid-impermeable filter. The length of the fluid path can be about 6 to 12 cm. Alternatively, the length of the fluid path may be about 3 to 6 cm. Alternatively, the fluid path may be longer than about 12 cm. Alternatively, the length of the fluid path may be about 3 to 6 cm. Alternatively, the fluid path may be longer than about 20 cm.

[0272] Figure 41E shows a collection container according to another example, where the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is long and tortuous to prevent wetting of the interface 1148. The tortuous path may include a coiled or bundled small-diameter tube 4108, either in whole or in part, of the fluid path. Preferably, the tortuous path is three-dimensionally tortuous.

[0273] Figure 41E shows a collection container according to another example, where the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is long and tortuous to prevent wetting of the interface 1148. In this embodiment, both the small-diameter tube 4108 and the tortuous path molded into the cassette are included. The tortuous path may be partially molded, partially tubular, all tubular, or all molded.

[0274] The inner diameter of the small-diameter tube 4108 may be about 1.8 to 2.0 mm. In some embodiments, the inner diameter may be about 1.6 to 1.8 mm. In some embodiments, the inner diameter may be about 1.4 to 1.6 mm. In some embodiments, the inner diameter may be about 1.2 to 1.4 mm. In some embodiments, the inner diameter may be about 1.0 to 1.2 mm. In some embodiments, the inner diameter may be about 0.8 to 1.0 mm. In some embodiments, the inner diameter may be about 0.5 to 0.8 mm. In some embodiments, the inner diameter may be about 0.2 to 5 mm. In some embodiments, the inner diameter may be less than about 4 mm. In some embodiments, the inner diameter may be less than about 3 mm. In some embodiments, the inner diameter may be less than about 2 mm.

[0275] In some embodiments, a drainage tube with a small inner lumen diameter is included. For example, in some embodiments, the inner lumen diameter is about 2 mm. In some embodiments, the inner lumen diameter is about 1 mm. In some embodiments, the inner lumen diameter is about 3 mm. In some embodiments, the inner lumen diameter is less than about 2 mm. In some embodiments, the inner lumen diameter is less than about 1 mm. In some embodiments, the inner lumen diameter is less than about 3 mm.

[0276] In some embodiments, the discharged urine can be used to "wash" air bubbles in the drainage tube or the collection reservoir. Returning the urine to the drainage tube, increasing the volume in the drainage tube, and assisting in "washing" air bubbles inside at least one of the tube and the reservoir can be achieved. The control unit compensates for the reused urine during urine volume calculation.

[0277] In some embodiments, pressurized air may be introduced into the drainage tube and / or the collection container. The forced air bounces and / or compresses the bubbles and also presses the urine against the surface of the system, reducing the formation of bubbles. The cross-sectional area of the drainage tube may decrease, remain the same, or increase as the drainage tube transitions to the flat portion.

[0278] Leveling

[0279] In embodiments where ultrasonic waves are used to measure the urine volume in the collection container, it is important that the ultrasonic waves have a surface (i.e., the surface of the urine volume) that forms an angle of approximately 90 degrees from the ultrasonic sensor. If the device tilts even a few degrees, the ultrasonic sensor may not be able to detect the surface of the urine, and accurate measurement of the urine volume may not be possible. To compensate for this, the collection container or the base / control unit may be attached to the bed via a self-leveling attachment, which is, for example, an attachment provided on rollers that causes the base to automatically level under gravity when the attachment is attached.

[0280] In some embodiments, slight angles within the system are processed by creating a "rough" surface on the urine volume in the collection reservoir. The "rough" surface causes multiple angles to be made with respect to the reflection of ultrasonic waves, some of which are at an angle of approximately 90 degrees from the ultrasonic sensor / transducer. The roughness can be formed by using air or other gas to foam the urine, and / or by vibrating the collection reservoir and / or the urine. The vibration can be obtained by mechanical means, ultrasonic means, etc. A floating plate floating on the surface of the urine can use one with a rough lower surface, a concave lower surface, or a convex lower surface. Floating beads can remain in the reservoir when the urine is discharged because their diameter is too large to exit the reservoir when the urine is discharged. To prevent the beads from entering the overflow region, mechanisms such as a net, a constriction, a small-diameter opening, etc. may be used. In addition, as described above, in order to accurately measure the urine volume, a cassette (i.e., a urine collection chamber) having an angled partition wall, or an angled wall portion or a wall portion that tapers towards the tip can also be used.

[0281] Priming of the pressure balloon

[0282] As priming to adjust the pressure of the pressure balloon and perform an optimal pressure detection measurement, a very small amount of air or fluid may be required. For this reason, an air / gas / fluid restrictor may be utilized between the priming fluid and the pressure balloon. With the restrictor, the priming pump can operate with a smaller amount of air and perform a more accurate priming of the pressure balloon. The restrictor may include a foam insert, a constriction of the fluid lumen, or any other suitable restrictor.

[0283] General improvements

[0284] In some embodiments, sensors on the bed, on the patient, within the sensing Foley catheter system, or elsewhere detect whether the patient is in the supine position. If the patient is not in the supine position, the measured pressure within the bladder may increase and may adversely affect the data analyzed by the control unit. As a result, the control unit can ignore the pressure data collected while the patient is not in the supine position or can stop collecting pressure data during this time. Alternatively, the pressure measurements themselves can be used to detect that the patient is not in the supine position. A sudden increase in pressure or an increase above a certain threshold may indicate that the patient is raising the upper body, moving, coughing, etc. Different pressure profiles can indicate different events. Patient rolling for bed shift prevention can be tracked in such a way.

[0285] In some embodiments, electrocardiogram measurements obtained through leads attached to the sensing Foley catheter system or obtained independently are used to synchronize the heartbeats measured via the heart rate within the bladder with the electrocardiogram.

[0286] In some embodiments, the angle of the bed can be used by the control unit as an input parameter to the calculation results such as IAP or APP. For example, increasing the body angle (raising the height of the patient's head) increases the IAP. This increase may be different for healthy patients and those who are not. As a result, by measuring the IAP at different bed angles, additional information regarding the patient's health status can be obtained. Also, it is possible to lower the IAP by lowering the head height and temporarily stabilize patients with a high IAP.

[0287] In some embodiments, the sensing Foley catheter will have at least one pressure sensor or lumen in fluid communication with an external pressure sensor. This pressure sensor can detect the pressure within the lumen at high speed, i.e., at a high frequency (ideally faster than 1 Hz), and monitor the physiological signals within the lumen. In some embodiments, the pressure lumen can be manually or automatically pressurized and / or depressurized while the pressure is being continuously or intermittently monitored. In embodiments where the pressure lumen includes a pressure balloon, the balloon can be inflated and / or deflated while monitoring the pressure exerted by the body on the pressure balloon. The pressure lumen can transmit pressure waves from the body cavity, one of which is the heartbeat generated by the inflow of blood, and can transmit to the luminal organ and / or the surrounding tissue. The pulsatile pressure due to the pulsation of the heart and / or the excitation of the respiratory system can be used to measure the pressures of the lungs and the cardiovascular system. In addition, the pressure within the pressure lumen / balloon can be increased significantly above a threshold value (e.g., 100 mmHg (about 13.33 kPa)), and then slowly decreased within the detection range to determine the origin of the pulse pressure, the disappearance point of the pulse pressure, and / or the relative increase or decrease in the pulse pressure size. The rise / fall, relative increase or decrease of the pressure pulsation detected by the pressure sensor can be correlated with blood pressure, perfusion pressure, mean arterial pressure, cardiac output, cardiac output variation, respiratory effort, pulmonary artery pressure transmission, and other pulmonary, gastrointestinal, renal, or cardiovascular system parameters. This process is similar to that of a blood pressure measurement cuff, where the pressure of the cuff is made higher than the blood pressure, and then the pressure of the cuff is slowly lowered until the blood pressure waveform (heartbeat) appears or disappears.

[0288] Figure 42 is a diagram showing the pressure waveform when the pressure balloon expands and its disappearance. Note that the pulsation of the heart decreases and / or disappears when it is greater than the mean arterial pressure. If there is sufficient data to correlate the degree of disappearance at the relative pressure point with the mean arterial pressure, it is possible to derive the mean arterial pressure from this relative pressure waveform. This can also be similarly used for pressures detectable within the body cavity, such as pulmonary pressure.

[0289] In some embodiments, the pressure sensor / lumen is a capsule, or balloon, or reservoir that can be slowly inflated or filled while monitoring pressure using an external transducer. In some embodiments, the pressure sensor is associated with a urethral 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 further embodiments, the pressure sensor device and the associated pressure increasing device may be fully implantable. In embodiments of tissue perfusion, the pressure detector is inflated against the urethra or the luminal surface and pulse oximetry is performed to detect blanching and / or perfusion of the luminal tissue at each pressure and measure the tissue perfusion pressure.

[0290] In some embodiments, the catheter can use multiple measurement parameters multiplicatively to improve the quality of data analysis. In one embodiment, the catheter incorporates a sensor for capturing an ECG signal from inside the body such as the urethra or bladder, or externally via sensors placed on the legs or waist. This signal is used to synchronize other measurement parameters (e.g., cardiac output) synchronized with the cardiac cycle with the electrical signal, and noise can be removed by taking the average value signal or the median value signal of a number of individual samples. In another example, the respiratory signal is used to guide which cardiac pressure signal should be used for cardiac output variation analysis by waiting for the model waveform to appear before performing the analysis.

[0291] FIG. 43 is a diagram showing a method of obtaining a clean signal for analysis by synchronizing a cardiogenic signal (such as pressure fluctuations in the bladder due to the pulse of the nearby abdominal aorta). When capturing an electrocardiogram in synchronization with other related cardiac signals, individual samples can be synchronized using, for example, the R wave of the electrocardiogram. In this figure, a plurality of pressure samples are captured, aligned using the R wave of the electrocardiogram, and superimposed. Subsequently, an intermediate signal is calculated by taking the median value of all pressure samples at the same time during the cardiac cycle. The average value can also be used. In this way, even if an abnormally high value appears due to noise in one sample, if an abnormally low value appears in the same way in another sample, they will cancel each other out, so random noise will be filtered. The more data points there are, the stronger the fundamental signal becomes and the more available it is for analysis. For example, in the illustrated pressure signal, the relative cardiac output can be derived from the amplitude between the peaks of the signal.

[0292] FIG. 44 shows a method of using a respiratory pressure signal to inform cardiac pressure signal analysis for measuring stroke volume variation (SVV). This method is effective especially for patients in a non-ventilated state, i.e., patients not wearing a ventilator. Existing cardiac output measurement techniques such as the thermodilution method and the pulse contour analysis method have limitations in measuring stroke volume variation (the variation in cardiac output between inhalation and exhalation) because the respiratory cycle is not visible. Using the intracavity pressure described in this specification, such as a Foley catheter in the bladder, is advantageous in that it can simultaneously capture respiratory signals and cardiac signals (as well as the relatively slow-moving intra-abdominal pressure). Thus, in this device, since specific characteristics are suitable for appropriate analysis (such as respiratory rate and magnitude), it is possible to selectively identify which respiratory cycle to use for the analysis of stroke volume variation. This figure shows a sample of the pressure signal captured from the bladder. In the upper raw pressure signal, large variations are due to respiration and are selected as analysis targets, for example, from the wave width, amplitude, peak value, etc. Other characteristics not shown, including slope, area under the curve, shape, frequency, pattern, or reproducibility, etc., can also be used to define an appropriate wave. It is also possible to use a curve amplitude filter that uses curves with amplitudes greater than a predetermined value and does not use curves less than the same predetermined value or another predetermined value for the calculation of SVV. The lower figure shows the state after passing the same signal through a high-pass filter and a low-pass filter. The high-pass filter leaves the underlying cardiac signal (dashed line), and the low-pass filter leaves the underlying respiratory signal (solid line). In this example, the difference in the strength of the cardiac signal (such as the peak-to-peak value) between the peak and trough of the respiratory signal can be used to calculate the stroke volume variation.

[0293] Respiratory rate and other parameters may be detected via a sensing Foley catheter or may be detected or acquired by any conventional or non-conventional means. Other parameters that may be collected include tidal volume, spirometry, respiratory flow parameters, data collected via spirometry, expiratory effort, inspiratory effort, etc. Any of these parameters can be used to assist in the calculation of stroke volume variation and / or other cardiac parameters.

[0294] The filter used to determine the pressure peak used in the calculation of SVV may be based on any of the pressure curve parameters disclosed herein. Additionally, in the calculation of SVV itself, it is also possible to determine which peak of the pressure curve to use in the calculation. For example, SVV typically falls within around 10%. The system disclosed herein can include or exclude pressure curve data based on the resulting SVV calculation being within a certain value range such as around 10%.

[0295] Also, the calculation of SVV can vary from patient to patient. For example, the pressure curve peak filter is based on amplitude, but the cut-off amplitude is patient-specific and can be based on the average, median, or other parameters of that patient's pressure curve. Alternatively, it is also possible to filter based on multiple patients, or multiple patients within a specific category such as a particular disease state.

[0296] The calculation of the signal and / or SVV can also filter out the patient's movement and / or other artifacts such as coughs, movements, sneezes, etc.

[0297] In addition, a calculation result that SVV is very low or does not exist may be a sign of fluid overload and appropriate treatment may be required in some cases.

[0298] In some embodiments of the disclosed system, the patient may be prompted to breathe in a specific manner. For example, based on the shape of the pressure curve (peak amplitude, frequency, etc.), the system can prompt the patient to breathe deeper, slower, normally, etc. The resulting respiratory pressure curve can be taken into account in the calculation of SVV. This type of prompting may also be performed by the system if the pressure curve is inappropriate for performing the SVV calculation or for other reasons.

[0299] Figures 45A and 45B are two - dimensional views showing the base components of the seal mechanism between the cassette and the control unit. Normally, the base components shown in Figures 45A and 45B are connected to the cassette, and the pins shown in Figure 46 are connected to the control unit. However, the reverse attachment method, where the pins are connected to the cassette and the base is connected to the control unit, is also possible. The purpose of the seal mechanism is to connect the lumen inside the cassette and the lumen inside the control unit when the cassette is connected to the control unit, and at the same time, to seal the lumen inside the cassette when the cassette is disconnected from the control unit. For example, the cassette may be temporarily disconnected from the monitor / control unit when transporting a patient to surgery or moving the room. While the cassette is removed from the control unit, it is desirable to seal the lumen so that the lumen of the cassette is not contaminated and urine, fluid, or gas does not leak into or invade the system.

[0300] For example, lumens such as the pressure balloon lumen (such as the pressure transducer interface 1026), the vent lumen 1180, the cassette pump interface 1148, and / or the cassette pressure interface 1150 can have such connectors.

[0301] Connectors' base 450 is shown in Figures 45A and 45B. The base can be manufactured from a compressible, strong, and inert material such as silicone or rubber, for example. Base 450 includes a slit 4506 having a length L3, in addition to base head 4504, base stem 4508, and base anchor 4502. Preferably, slit 4506 is a single linear slit, but after the base is molded, a sharp knife is used so that the edges of the slit do not become rounded and can be completely sealed in a relatively loose state. When base 450 is connected to the lumen, fluid flow stops from the slit in the base.

[0302] The pin portion 460 shown in FIG. 46 includes a pin head 4604 and a pin stem 4602 that includes a lumen passing therethrough. The pin stem 4602 has an outer diameter of D3. The pin 460 is fitted inside the slit 4506 of the base 450 and is arranged in such a manner that fluid can pass through the seal mechanism. In some embodiments, L3 is substantially the same as D3.

[0303] FIGS. 47A and 47B are diagrams showing a mode in which the pin 460 is inserted into the slit 4506 of the base 450, thereby enabling fluid to flow through the lumen of the pin and pass through the seal mechanism.

[0304] FIG. 48 is a diagram showing the base 450 of the seal mechanism on the back of the cassette designed to fit into the opening of the control unit. The base of the seal mechanism shown here is connected to a pressure balloon lumen interface 4802, a vent lumen interface 4804, a cassette pump interface 4806, and a cassette pressure interface 4808 (for IAP measurement). Note that these types of seal mechanisms may or may not be adopted for all cassette interfaces, either in part or not at all. For example, the pressure interface 4808 for measuring IAP does not need to be sealed when the cassette is disconnected, and different types of connectors can be used.

[0305] FIG. 49 is a diagram showing the operation of the seal mechanism when the cassette is connected to the control unit. The cassette 1022 is a cross-sectional view in which one of the seal mechanisms is installed. The base 450 is attached to the cassette portion and is attached in a sealed state when the pin 460 is not provided. The pin 460 is connected to a control unit (not shown), and when the cassette 1022 is fitted into a predetermined position of the control unit, the pin 460 is inserted into the slit of the base 450, thereby enabling fluid to flow into the cassette from the control unit or from the cassette to the control unit. The connection portion may include a filter shown as a filter 4902 here.

[0306] FIG. 50 shows the schematic dimensions of the base 450 according to one embodiment. These dimensions may vary depending on the application.

[0307] FIG. 51 is a diagram showing a part of the force applied to the base 450 when the entire base 450 is installed in the cassette. These forces are caused by the diameter of the installation hole versus the diameter of the stem 4508, and the thickness of the cassette wall versus the length of the stem 4508. In addition, when the cassette is attached to the control unit, a compressive force can press the base head 4504. These forces tend to strengthen the seal of the base 450 regardless of whether the pin is inserted into the slit. That is, based on the dimensions and shape of the base, a force is applied so that the slit is supported to remain either closed by itself or closed by the pin. The force is pushing the slit into its inner side. Also, since the bottom surface of the head 4504 is slightly concave (like a mushroom), the bottom surface (the wider part) tends to expand and the upper surface (the part with the slit opening) tends to be compressed. This is particularly true when the wall thickness of the cassette is greater than the length of the stem 4508.

[0308] FIGS. 52A and 52B are diagrams showing an embodiment of the seal mechanism in which the base or the head or other components include the orientation element 5202. The orientation function can be matched with a similar orientation function on or within the opening of the cassette so that the seal mechanism is oriented at a specific position within the opening of the cassette during assembly.

[0309] In some embodiments, multiple drainage lumens can be used to prevent air locks. The proximal and / or distal openings may be staggered. The lumen may or may not be incorporated into a single or multiple tubes and hold a siphon. For example, two drainage lumens may be used, three drainage lumens may be used, four drainage lumens may be used, five drainage lumens may be used, six drainage lumens may be used, seven drainage lumens may be used, eight drainage lumens may be used, or more than eight drainage lumens may be used.

[0310] In any of the embodiments disclosed herein, the vent tube can be connected to a standard or non-standard Foley catheter by attaching it to a sampling port of the Foley catheter, or a barb near the Foley catheter, or anywhere in the drainage system. See, for example, FIG. 53.

[0311] FIG. 53 shows an embodiment including a ventilation mechanism / vent tube that can be added to any suitable urine drainage system including any suitable port such as sampling port 1004. In this embodiment, the ventilation mechanism 5300 can vent the sampling port 1004 to the system vent to avoid an air lock. The ventilation mechanism 5300 includes a vent tube 5302 and optionally a valve 5304 and / or a filter 5306. The ventilation mechanism can also include a needle, or a piercing mechanism or a blunt tube 5308 that pierces or opens / accesses the sampling port 1004 and holds open a lumen in fluid communication with the drainage lumen 1012 to perform the ventilation function. In this figure, the sampling port is shown as part of barb 1016, but the sampling port may be provided at any location within the drainage system including within the drainage line, as part of the drainage catheter, between the drainage catheter and the drainage line, or elsewhere. Alternatively, any other port or access point can be used. This embodiment may or may not use a vacuum pump. The vent tube may be rigid, flexible, or bendable. The vent mechanism may include means for suspending the vent tube above the level of the bladder, for example 1 to 10 cm above the level of the bladder. The length of the vent tube may be just greater than 1 cm. Alternatively, the length of the vent tube may be just greater than 2 cm. Alternatively, the length of the vent tube may be just greater than 3 cm. Alternatively, the length of the vent tube may be just greater than 4 cm. Alternatively, the length of the vent tube may be just greater than 5 cm. Alternatively, the length of the vent tube may be just greater than 10 cm. The inner diameter of the vent tube may be less than about 5 mm. Alternatively, the inner diameter of the vent tube may be less than about 4 mm. Alternatively, the inner diameter of the vent tube may be less than about 3 mm. Alternatively, the inner diameter of the vent tube may be less than about 2 mm. Alternatively, the inner diameter of the vent tube may be less than about 1 mm.

[0312] In this figure, the vent tube 5302 is shown as terminating in the atmosphere, but as shown in FIG. 11E, the vent tube may be connected to a drainage bag. When a valve and a vent are provided, the valve may be provided between the sampling port and the vent, or the vent may be provided between the sampling port and the valve. This type of ventilation mechanism can be implemented at the sampling port after the first volume of urine has been drained from the bladder. This type of ventilation mechanism may also be incorporated into straps or patches for securing the barb to the patient's leg or the like. The ventilation mechanism / vent tube of the present embodiment may have one or more small-diameter portions having a length as shown in FIG. 11D. For example, the portion of the vent tube 5302 may be relatively small in diameter and relatively long to prevent urine from moving through the vent tube and reaching the valve and / or filter.

[0313] Rather than using the piercing mechanism 5308 in conjunction with the sampling port 1004, a piercing mechanism may be used along the tube of a catheter or drainage tube. Alternatively, although the port is normally closed, it is also possible to use a mechanism that accepts an add-on vent mechanism / vent tube. For example, a seal mechanism-pin structure as shown in FIGS. 45 to 52B is used, in which the base is on the catheter / drainage tube and the pin may be part of the ventilation mechanism / vent tube or vice versa. In some embodiments, the port 1004 may be provided on an add-on barb or connector component intended to be disposed between the catheter and the drainage tube.

[0314] Any of the embodiments of the vent tube disclosed herein can also be used, in addition to or instead of, to ventilate a drainage bag or cassette. For example, the bag vent 1142 shown in FIG. 10A may incorporate any of the vent tube designs. Alternatively, for example, the vent 1180 shown in FIG. 11A may incorporate any of the vent tube designs.

[0315] Figures 54A and 54B are diagrams showing a valve according to an embodiment, including a tube seating mechanism. The valve 5402 includes a urine drainage tube 5404 surrounding a urine drainage lumen 5406 and a vent tube 5408 surrounding a vent lumen 5410. Tubes 5404 and 5406 are inserted into the valve during manufacture and seat against a step 5412. Thereby, as shown in Figure 54B, both the urine drainage lumen and the vent lumen are opened into a single lumen 5416 of the catheter manifold 5414.

[0316] In some embodiments, the control unit controls a pressure sensor in or near the valve to determine when the pressure in the valve region is not overly negative so that the drainage line can be evacuated without causing suction trauma to the bladder. Also, the pressure sensor may be used to determine the initial placement of the system so that the pressure in the drainage line is surely not positive or does not become overly negative. When the pressure in the drainage line becomes too negative, the control unit can operate a valve in the urine collection reservoir or the like to temporarily stop or slow down urination to make the pressure not negative and reduce the possibility of suction trauma to the bladder.

[0317] In some embodiments, the bladder is periodically pressurized to assist in discharging urine from the bladder. This can be done using a retention balloon, a pressure sensing balloon, another balloon, or the like.

[0318] In some embodiments, the elimination of the air lock is performed intermittently. In some embodiments, the elimination of the air lock is performed continuously, for example, by continuously evacuating the drainage line slightly.

[0319] In some embodiments, pulse oximetry data may be collected from the patient's skin, for example, from the thigh, or other locations such as the groin or leg.

[0320] In some embodiments, the control unit manages at least one of the air volume and pressure of the entire system. For example, the control unit can detect when the urine collection bag is overpressurized, which can occur when the air filter (shown as 1142 in some figures) is blocked or wet. Therefore, the risk of the bag bursting increases. In this case, the control unit can instruct the system to perform one or more things to mitigate the problem. The control unit may attempt to clean the filter by "blowing" air onto the filter. The control unit can slow down or stop the urine discharge by slowing down or stopping the air lock release pump. The control unit can instruct the pump to rotate in reverse intermittently to reduce the pressure in the drainage bag. The control unit may warn the user to change or otherwise manually correct the problem with the drainage bag. The control unit can monitor the pressure at any point in the system, identify problems related to the pressure, and in some cases mitigate them. The control unit can monitor the pressure in valves, in the drainage line, in the vent line, in the reservoir / cassette, in the drainage bag, etc. For example, the control unit can control the pressure in the cassette to assist in emptying the cassette, cleaning the filter, reducing air bubbles, etc.

[0321] In some embodiments, acute kidney injury (AKI), or other symptoms can be detected early, or in some cases at least one of prediction and prevention can be performed. For example, currently, AKI is classified using the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria. The RIFLE criteria have the following classifications.

[0322] [Table 1]

[0323] Embodiments of the Foley catheter system for detection disclosed herein can measure urine volume, as well as intra-abdominal pressure and other parameters, in real time and frequently or continuously, so that a patient's health parameters can be evaluated over time in context. For example, it is also possible to continuously measure urine volume, capture the data, and store and analyze it over time. Patient 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. It is possible to program to issue a warning when or before the occurrence of AKI risk, injury, and failure based on the RIFLE criteria. Patient weight and / or other patient data can be received by the system control unit by manual user input, integration with other hardware such as a weighing scale, integration with a lifetime electronic medical record or an electronic medical record, wireless transmission, or other means.

[0324] In addition, the Foley catheter system for detection can also use different algorithms or improve existing algorithms to predict or identify a patient's symptoms. For example, by considering urine volume data available at an earlier time, the risk of kidney injury or disorder can be predicted earlier than the RIFLE criteria.

[0325] As an example, referring to FIGS. 55A to 55E, FIG. 55A is a graph showing the change in urine volume over time in one-hour increments. The scale of the urine volume shows a line at 0.5 mL / kg / h. According to the RIFLE criteria, if the urine volume is below this amount for six consecutive hours, there is a risk of kidney injury. The most recent six urine volume measurements (at the 12th to 17th hours) show symptoms indicating an increased risk of kidney injury according to the RIFLE criteria. The Foley catheter system for detection can add more information beyond these data to the patient's symptoms. For example, looking at the urine volumes at the 9th, 10th, and 11th hours, it can be seen that the urine volume is decreasing in each time period. After this decrease, it was shown that if the urine volume for three hours is less than 0.5 mL / kg / h, it is predicted that the urine volume for the next three hours will also be less than 0.5 mL / kg / h. That is, if the urine volume is less than 0.5 mL / kg / h for three hours following a decrease in urine volume (even if it is greater than 0.5 mL / kg / h), the risk of kidney injury can be predicted earlier than the RIFLE criteria. The Foley detection system can predict the AKI risk three hours earlier than the current RIFLE criteria.

[0326] FIGS. 55B to 55E are additional examples showing possible ways to predict the risk of kidney injury earlier than the RIFLE criteria. FIG. 55B is a diagram showing an algorithm for predicting the risk of kidney injury using the trend of urine volume decrease data for several hours before the urine volume less than 0.5 mL / kg / h continues for three hours. FIG. 55C is a diagram showing an algorithm for predicting the risk of kidney injury using the moving average of urine volume for several hours before the urine volume less than 0.5 mL / kg / h continues for three hours. FIG. 55D shows an algorithm for predicting the risk of kidney injury using the moving average of urine volume over several hours. FIG. 55E shows an algorithm for predicting the risk of kidney injury by more complex analysis of urine volume data over multiple hours.

[0327] The detection Foley system can predict the AKI risk up to 1 hour earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk up to 2 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk up to 3 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk up to 4 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk up to 5 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk up to 6 hours earlier than the RIFLE criteria.

[0328] Instead of this, the detection Foley system can predict the AKI risk more than 1 hour earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk more than 2 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk more than 3 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk more than 4 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk more than 5 hours earlier than the RIFLE criteria. Instead of this, the detection Foley system can predict the AKI risk more than 6 hours earlier than the RIFLE criteria.

[0329] The detection Foley system can predict kidney injury up to 1 hour earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury up to 2 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury up to 3 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury up to 4 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury up to 5 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury up to 6 hours earlier than the RIFLE criteria.

[0330] Alternatively, the detection Foley system can predict kidney injury more than 1 hour earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury more than 2 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury more than 3 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury more than 4 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury more than 5 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict kidney injury more than 6 hours earlier than the RIFLE criteria.

[0331] The detection Foley system can predict renal failure up to 1 hour earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure up to 2 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure up to 3 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure up to 4 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure up to 5 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure up to 6 hours earlier than the RIFLE criteria.

[0332] Alternatively, the detection Foley system can predict renal failure more than 1 hour earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure more than 2 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure more than 3 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure more than 4 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure more than 5 hours earlier than the RIFLE criteria. Alternatively, the detection Foley system can predict renal failure more than 6 hours earlier than the RIFLE criteria.

[0333] In some embodiments of the detection Foley system, the RIFLE risk can be identified 3 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, the RIFLE risk can be identified 1 to 3 hours earlier than predicted by the conventional RIFLE criteria. The RIFLE risk can be identified 1 to 2 hours earlier than predicted by the conventional RIFLE criteria. The RIFLE risk can be identified 3 to 5 hours earlier than predicted by the conventional RIFLE criteria.

[0334] In some embodiments of the detection Foley system, RIFLE damage can be identified 9 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, RIFLE damage can be identified 1 to 3 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, RIFLE damage can be identified 3 to 5 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, RIFLE damage can be identified 5 to 8 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, RIFLE damage can be identified 8 to 9 hours earlier than predicted by the conventional RIFLE criteria. In some embodiments of the detection Foley system, RIFLE damage can be identified 9 to 10 hours earlier than predicted by the conventional RIFLE criteria.

[0335] Figures 55A through 55E show an algorithm that uses urine volume data over time, but other parameters besides urine volume, or in addition to urine volume, can be used in the symptom prediction or identification algorithm. For example, intra-abdominal pressure data, body temperature data, respiratory rate data, and / or heart rate data over time can also be factored into the AKI risk algorithm. For example, renal perfusion and glomerular filtration gradient are affected by lAP, and lAP often rises prior to oliguria and an increase in serum creatinine.

[0336] Figures 56A through 56C are diagrams showing a detection Foley system according to one embodiment, including a peristaltic pump. In some embodiments, the pump may be incorporated into the monitor / control unit and the reservoir or cassette. The peristaltic pump can be used in any of the embodiments disclosed herein that include a pump. Figure 56A shows a cassette 1022 that includes a flexible membrane 5602. The flexible membrane forms a space between the cassette, which is relatively rigid compared to the membrane. Fluid is forced through that space by the rotational action of roller 5604. Fluid channels 5606 and 5608 are shown here as part of the cassette. When the pump roller rotates over the flexible membrane, the fluid is forced to move from the input fluid channel 5606 through the membrane space and out the output fluid channel 5608. In this way, the peristaltic pump moves fluid from the drainage tube, into the input fluid channel, through the membrane space, and out the output channel, into the reservoir area (not shown) of the cassette.

[0337] Figure 56B is a side view of the cassette including membrane 5602 and output channel 5608.

[0338] Figure 56C is a side view of the cassette showing the peristaltic pump 5610 engaged with the cassette. When pump 5610 rotates, roller 5604 rotates around the membrane, forcing liquid into the reservoir of the cassette. The pump may be built into the monitor / control unit.

[0339] Although only one pump is shown here, two or more pumps may be provided. The same pump or a separate pump can also be used to apply negative pressure to the drainage tube to empty the reservoir of the cassette. The pump may have two rollers, one roller, or three or more rollers. The channels can be configured in any arrangement that allows the pump to function properly. The pump may operate continuously or intermittently.

[0340] Figures 57A to 57C are diagrams showing example screenshots of the embodiments disclosed in this specification. These screenshots may be displayed on the monitor / control unit, or may be remotely displayed, for example, on a computer, tablet, or the like. These screenshots can be particularly applied to embodiments including a controlled feedback loop or a loop control unit, such as the embodiments shown in FIGS. 26 to 30.

[0341] The screen shown in FIG. 57A is for a specific patient. At least one of the patient ID number and the patient name can also be displayed. Other biometric information of the patient, such as weight, age, gender, etc., may also be included on the display. On this screen, three display options for fluid balance, vital signs, and risk indicators are shown. These display options can be selected by clicking on tab 5702, tab 5704, or tab 5706, respectively. In FIG. 57A, the fluid balance tab is selected. The desired fluid balance is indicated by the dotted line 5708. The actual fluid balance over time is indicated by the solid line 5710. The current fluid balance is indicated by the reference numeral 5712. Also shown on this screen are the various states and some settings of various types of devices connected or not connected to the patient.

[0342] For example, in the urine output area 5714, options to connect or disconnect this device to the loop control system are displayed. The connection of this device can be performed via this screen when inserting a sensing Foley catheter into the patient's body according to any embodiment of the Foley catheter system. Also, data on the insertion date and the number of days of indwelling of the sensing Foley catheter are displayed. The urine output rate and / or urine volume can be used for fluid balance analysis by the loop control unit.

[0343] The enteral nutrition area 5716 can indicate whether the nutrition device is connected to the loop control unit and what model it is. In addition, the supply amount, supply speed, etc. can be set. The supply speed and / or amount can be used for fluid balance analysis by the loop control unit. In some enteral tube models, the gastric residual volume (GRV) or gastric drainage volume 5724 can be detected and incorporated into the body fluid balance analysis.

[0344] The intravenous infusion pump area 5723 can indicate whether the infusion pump is connected to the loop control unit and what model it is. Other settings may include the infusion volume and infusion speed. The infusion speed and / or infusion volume can be used for body fluid balance analysis by the loop control unit.

[0345] The wound drainage area 5722 can indicate whether the wound drainage system is connected to the loop control unit and what model it is. The wound drainage speed and / or amount can be used for body fluid balance analysis by the loop control unit.

[0346] Also, the pulse oximeter area 5718 and the electrocardiogram area 5720 are also shown. These are not directly related to the body fluid balance, but may also be monitored by the loop control unit. These sensors may be part of a detection Foley system, for example.

[0347] The loop control unit can collect data from various body fluid input / output devices and control these devices to maintain the body fluid balance in a patient's body in a desired state. For example, when a patient urinates at a volume rate higher than the input rate of body fluid by nutrition supply and / or infusion, the patient's body fluid balance will be more negatively inclined. When the body fluid balance drops below the desired range, the nutrition supply rate and / or infusion rate can be increased to return the body fluid balance within the desired range. Alternatively, when the body fluid balance is positively inclined too much (there is too much body fluid), the nutrition supply amount and / or infusion amount can be decreased until the body fluid balance returns to the desired range. Other fluid output measurements may also be appropriately included, such as wound drainage shown in region 5722. Also, water loss due to sweat, exhalation, and defecation can be considered by the loop control unit in the body fluid balance analysis. The connection of these devices is not shown on this screen but may be included. The desired body fluid balance range can be set through settings such as the region 5725 shown here, for example.

[0348] The various devices to be connected may be automatically detected or manually connected via a mechanism such as Bluetooth (registered trademark).

[0349] Figure 57B is a diagram showing another example of a screen of the loop control unit system. This screen shows an example of the content displayed within the "Vital" tab area. This area displays one or more vital signs of the patient over time. The time axis can be changed via, for example, button 5726. Here, it shows the patient's body temperature, heart rate, respiratory rate, urine volume (or urine output rate instead), intra-abdominal pressure, and the measured values of a pulse oximeter over time. Other vital signs may also be displayed. For example, an electrocardiogram, body weight, blood pressure, etc. may be displayed. Some or all of these measured values can be collected by a sensing Foley catheter system.

[0350] FIG. 57C is a diagram showing an example of a screen on the back side of the "Body Fluid Balance" tab. Here, the setting area shown in FIG. 57A is minimized at the bottom of the screen. The ongoing and current actual body fluid balance and the desired body fluid balance are displayed at the top of the screen. Also, the IV infusion volume, enteral nutrition volume, urine volume, and wound drainage volume are also displayed over time as needed. In this example, since the wound drainage device is not being used on the patient, no data is displayed on the graph.

[0351] The risk area of the display can display the risks of various medical conditions based on some or all of the data collected from the sensing Foley catheter system and / or other devices. For example, the AKI risk, sepsis risk, and other risks can be evaluated by the control unit and displayed here. Also, various parameter settings used for risk assessment can be input to or collected by the control unit. For example, the patient's weight can be input into the risk profile.

[0352] FIGS. 58A and 58B are diagrams showing a sensing Foley catheter system according to an embodiment, including the analysis and recording of various urine parameters. FIG. 58A shows a cassette for collecting urine output, which includes an optically transparent portion 5804 and a test strip 5806. The test strip 5806 includes one or more test strip segments 5808. The test strip segments can change color based on various parameters of the urine. For example, the test strip segments may test for the presence of white blood cells, nitrites, urobilinogen, proteins, hemoglobin ketone, bilirubin, acetone, glucose, hormones, drugs, creatinine, or other entities, or the test strip can determine the pH, specific gravity, color, or other parameters of the urine. The test strip segments can also test for pathogens.

[0353] The camera 5802 is preferably a visible light camera, but may also be a camera that detects wavelengths of light other than the visible spectrum, and may be incorporated into the monitor / control unit. The camera can be automatically or manually moved up and down by the control unit to capture images of test paper segments in various rows on the test paper. Alternatively, the camera lens may have a wide enough angle to capture an area large enough to monitor the liquid surface over the required range. Alternatively, a plurality of cameras may be mounted and made communicable with the control unit. These camera options are applicable to any embodiment incorporating at least either any type of camera and wavelength detector disclosed in this specification.

[0354] The test paper 5806 may include a plurality of test paper segments in a plurality of rows. Preferably, each row is the same, but may be different. Each row includes one or more test paper segments, and each test paper segment can inspect different parameters. For example, the test paper may include two different test paper segments in two or more rows. Alternatively, the test paper may include three different test paper segments in two or more rows. Alternatively, the test paper may include four different test paper segments in two or more rows. Alternatively, the test paper may include five different test paper segments in two or more rows. Alternatively, the test paper may include six different test paper segments in two or more rows. Alternatively, the test paper may include seven different test paper segments in two or more rows. Alternatively, the test paper may include eight different test paper segments in two or more rows. Alternatively, the test paper may include nine different test paper segments in two or more rows. Alternatively, the test paper may include ten different test paper segments in two or more rows. Alternatively, the test paper may include two or more different test paper segments in two or more rows. Alternatively, the test paper may include three or more different test paper segments in two or more rows. Alternatively, the test paper may include four or more different test paper segments in two or more rows. Alternatively, the test paper may include six or more different test paper segments in two or more rows.

[0355] FIG. 58B is a diagram showing a test strip 5806 having 10 rows of 7 different test strip segments.

[0356] To expose different rows of the test strip segments to urine when urine is collected, as shown in FIG. 58A, the test strip array may be enclosed within the urine collection chamber. When urine is collected in the chamber, it may first contact the lowermost segment of the test strip segments. Alternatively, the bottom (first) row of the test strip segments may be above the level corresponding to the volume at which the collection chamber empties. In this embodiment, urine may first be brought into contact with the lower rows of the test strip segments by a control unit that controls a pump to draw a vacuum through the cassette pump interface 1148. The vacuum drawn by the vacuum pump temporarily lifts the row of urine in the cylinder 5809 of the cassette via the vacuum path 5810, thereby enabling the urine to contact subsequent rows of the test strip segments. The control unit may be programmed to periodically draw a vacuum and then periodically expose higher rows of the test strip segments to urine to examine the collected urine. In this way, multiple tests can be performed individually by exposing a new test strip to urine. The number of rows of the test strip corresponds to the number of fresh tests that can be performed on each test strip. For example, row 1 of the test strip is used first, then row 2 is used, and so on.

[0357] The camera may move gradually higher each time a row of the test strip is used. Alternatively, the camera's field of view angle can be changed to view subsequent rows of the test strip.

[0358] The test strip can be replaced via a sterilized cartridge, and it can be replaced when this cartridge is removed.

[0359] The camera can detect the color of the test strip segment rows, compare it with a standard color array, and determine whether any of the parameters of the test strip segments indicate that the urine is outside the range of that parameter. The camera may be calibrated to a standard color array.

[0360] Other configurations of the camera and / or test strip are also envisioned. For example, the reading of the test strip can be done manually rather than automatically via the camera / control unit.

[0361] FIG. 59 shows a sensing Foley catheter system according to one embodiment that includes a pump 5902 that acts directly on the urine drainage lumen 1012 or a pump 5902 that acts in line with the urine drainage lumen 1012. This type of pump may be a positive displacement pump, a peristaltic pump, a centrifugal pump, or any other type of pump including those described herein. FIG. 59 further shows a pump bypass lumen 5904 that connects to the urine drainage line both upstream and downstream of the pump 5902. The bypass lumen 5904 includes a one-way valve 5906. This embodiment operates similar to other embodiments disclosed herein, but the bypass lumen allows the pump to be bypassed for urine drainage in these or other situations where there is a risk that the pump may block the urine drainage line when a failure occurs or when the pump is not operating fast enough to keep up with the flow of urine drainage. The one-way valve prevents urine from moving upward within the bypass lumen and allows the pump to effectively prime the drainage line to eliminate an air lock. A vent 1180 may be provided to allow air to enter the vent line. Additionally, a vent 5908 may be provided to allow air to escape from the cassette 1022.

[0362] FIG. 60 is a diagram showing an embodiment including a pump mechanism that can be added to any urine drainage system including any standard Foley system having a drainage line such as drainage line 1012. The add-on pump mechanism can be included in a container such as container 6002 that can be arranged alongside the drainage line. The pump mechanism can operate in the same manner as that shown in FIG. 59, as shown here. The pump mechanism can be connected between the drainage line and the drainage bag, or at any location along the drainage line. The pump mechanism may include a proximal connector and a distal connector.

[0363] FIG. 61 is a diagram showing another example including a pump mechanism that can be added to any urine drainage system including any standard Foley system having a drainage line such as drainage line 1012. The add-on pump mechanism may or may not include an external container. The pump mechanism can be connected between the drainage line and the drainage bag, or at any location along the drainage line. The pump mechanism may include a proximal connector and a distal connector. This embodiment includes an inlet side one-way valve 6102 and an outlet side one-way valve 6108. Between the two one-way valves, a non-obstructed tube length, that is, a reservoir 6104, is provided so that the flow of urine is never obstructed. The pump 6106 may be a simple syringe, a flexible squeeze valve, or a more sophisticated pump mechanism. A filter may be provided between the pump and the reservoir 6104. The pump can be either manual or automatic.

[0364] FIG. 62 is a diagram showing an embodiment including a fluid flow meter that can be added to any urine drainage system including any standard Foley system having a drainage line such as drainage line 1012. The add-on fluid flow meter mechanism 6202 can be included in a container such as container 6204 that can be placed alongside the drainage line. The fluid metering mechanism can be connected between the drainage line and the drainage bag or at any point along the drainage line. The pump mechanism may include a proximal connector and a distal connector. The fluid flow meter mechanism may be a pressure-based, resistance-based, capacitance-based, ultrasonic-based, weight-based, or optical-based technology, or any other suitable technology.

[0365] FIG. 63 shows an embodiment including a weight-type fluid flow meter. The weight control unit 6302 includes the function of measuring the weight of the urine collection reservoir, in this case the bag, via the weight sensor 6306, and optionally also measuring the weight of the urine drainage line via the weight sensor 6304, whereby the weight / movement of the urine drainage line can be incorporated into (e.g., subtracted from) the calculation of urine flow or total urine output. The urine flow and / or the urine volume in real time can be measured and optionally displayed on the weight control unit 6302 or elsewhere. Similar to any of the embodiments disclosed herein, the data from the weight control unit may be remotely transmitted, aggregated, analyzed, etc. on a computer server and / or transmitted to various users.

[0366] FIG. 64 is a diagram showing a standard Foley catheter system with a standard drainage bag that integrates embodiments similar to FIGS. 53, 61, and 63. That is, three modular components are added to and used with a standard Foley catheter and drainage system.

[0367] - Add-on ventilation mechanism, 6402

[0368] - Add-on pump / air lock elimination mechanism, 6404.

[0369] - Add-on urine volume measurement mechanism, 6406.

[0370] By adding these three add-on mechanisms to a standard Foley catheter drainage system, in addition to eliminating air locks, it is improved so that accurate urine volume measurement can be performed in real time. In addition, it is also assumed that these three add-on mechanisms can be combined. For example, an optical urine volume measurement mechanism may be used. These mechanisms can be used on one system by combining any one, two, or three of them.

[0371] Figures 65A through 65D show a Foley catheter system according to one embodiment that includes a function for measuring the specific gravity osmolality of urine, and this function can be used for diagnosing, predicting, or monitoring a specific health condition. The specific gravity osmolality of urine is measured by measuring the rate at which urine passes through a filter with a specific pore size under a specific differential pressure applied to the filter. In some embodiments, the measurement of the specific gravity osmolality of urine may be incorporated into the cassette / monitor of the system. Figure 65A shows a cassette 1022 according to one embodiment that includes a main urine collection region 6502, a bubble column 6504, a one-way valve 6506, a filter membrane 6508, a first pressure sensor and pump-cassette interface 6510, a second pressure sensor and pump-cassette interface 6512, an ultrasonic (or other) urine volume measurement mechanism 6514, and a one-way emptying valve 6516. The pressure interfaces 6510 and 6512 can measure the pressure within the main urine collection region 6502 and the bubble column 6504, respectively, and / or apply positive and / or negative pressure to them. Both the one-way valve 6506 and the filter membrane 6508 are provided at the bottom of the cassette where the main urine collection section and the bubble column are connected, or in the vicinity thereof. The valve 6506 and the membrane 6508 are shown overlapping each other here, but they are likely to be adjacent to each other as close as possible to the bottom of the cassette. While urine is being collected in the cassette, the one-way emptying valve 6516 is closed.

[0372] When urine is collected, as shown in FIG. 65A, the urine moves from the main urine collection region 6502 through the membrane 6508 into the bubble column 6504. To perform a weight osmolality measurement, the control unit pressurizes the bubble column 6504 via the pressure interface 6512 and, as shown in FIG. 65B, forcibly feeds all the urine in the bubble column back into the main collection region 6502 via the valve 6506. The pressures in the main collection chamber 6502 and the bubble column 6504 are monitored via the pressure interfaces 6510 and 6512, respectively. When there is no urine in the bubble column, air bubbles pass through the one-way valve 6506. This can be detected by the control unit through the pressure measurements of the main collection region and the bubble column, and at this point, the control unit can recognize that the bubble column has emptied. The control unit then reduces the pressure in the bubble column 6504 so that urine can pass from the main collection chamber 6502 through the filter membrane 6508 into the bubble column 6504. The pressure in the main collection chamber, in addition to the bubble column, the amount of urine in the main collection chamber is monitored. At a given differential pressure (zero or greater than zero), the rate at which urine passes through the filter membrane and into the bubble chamber is related to the weight osmolality of the urine. Thus, the weight osmolality of the urine may be measured by the control unit. The amount of urine in at least one of the main collection region and the bubble column can be monitored by ultrasound, pressure, or other mechanisms.

[0373] FIG. 65C is a diagram showing the cassette after a portion of the urine has moved from the main collection chamber through the filter membrane into the bubble column.

[0374] FIG. 65D is a diagram showing the manner in which the control unit opens the valve 6516 to empty the cassette so that urine is discharged from the cassette. The discharge of urine from the cassette may be facilitated by pressurizing the main collection region 6502 and / or the bubble column 6504.

[0375] Osmolality measurements may be performed periodically to measure the change in urine osmolality over time. For example, osmolality measurements may be performed each time the cassette is filled / emptied. Alternatively, osmolality may be measured at specific time intervals.

[0376] The filter membrane can be periodically cleaned by passing pressurized air across the membrane.

[0377] Some embodiments can include electrodes for measuring conductivity within or on the cassette to measure the concentrations of various conductive and non-conductive solutes in urine, such as salts, sodium (Na), creatinine, urea, uric acid, glucose, potassium, chloride, inorganic phosphate, nitrite, calcium, magnesium, chlorine, hormones, vitamins, drugs, etc. The electrodes may be gold or silver plated to prevent the accumulation of biofilm. The biofilm can be removed / prevented by vibration, ultrasonic waves, etc. It is also possible to use non-contact impedance electrodes / measuring instruments.

[0378] Figures 66A and 66B are diagrams showing a cassette according to an embodiment, including electrodes 6602 for measuring the conductivity of urine within the cassette. Figure 66A shows the front of the cassette, and Figure 66B shows the back of the cassette. The electrodes may be on the inner surface of the cassette, embedded within the wall of the cassette, or arranged elsewhere.

[0379] Figures 67A and 67B are diagrams showing a control unit according to an embodiment for use in combination with the cassette shown in Figures 66A and 66B. Figure 67A shows the state in which the cassette is attached to the control unit. It further shows a display displaying a graph 6702 of the change in Na+ concentration over time. The display may or may not have units. When there are no units, the numbers simply indicate relative numerical values, which are effective for grasping the changes. Changes in Na+ (or any other analyte) levels or general conductivity can suggest changes in urine volume and the arrival of other health information. For example, the urine conductivity can increase before the urine volume decreases. Thus, conductivity can be an indicator for early detection of a decrease in urine volume and, ultimately, an indicator of the patient's health status. Embodiments of the device can sound an alarm or communicate when certain conductivity parameters, such as a sharp increase or decrease in conductivity, are detected or analyzed.

[0380] Figure 67A is a diagram showing the control unit of Figure 67A in a state where the cassette is not attached. An electrode connector 6704 that contacts the electrode 6602 on the cassette is shown. The electrode connector is shown here within an opening 6706 that receives the cassette.

[0381] Some embodiments of the device combine information from different sensors to evaluate the patient's health status. For example, the combination of a high urine volume and a high urine conductivity can be an indicator of a specific health status.

[0382] Electrodes of different sizes, numbers, types, and / or positions can be used to detect different parameters of urine. It is also possible to detect multiple parameters at once.

[0383] In some embodiments, the control unit is initially in a standby state. When the control unit detects through sensors such as pressure, volume, ultrasonic, and optical sensors that urine has first entered the cassette, the control unit can automatically start up and begin functions such as monitoring urine volume and releasing the air lock.

[0384] Similar to any of the embodiments disclosed herein, a pressure sensor may be included elsewhere in the system, such as in a valve region, to monitor the pressure (positive or negative) within the system and determine when the pressure is optimal for fluid drainage. For example, the signal from the pressure sensor in the valve can be monitored by a monitor / controller to achieve an optimal pressure range, such as about 0.5 mmHg (about 66.66 Pa). Within this optimal pressure range, appropriate air lock elimination and fluid drainage can be achieved without applying excessive negative pressure to the bladder. The control of this optimal pressure range can be performed periodically or continuously by the controller controlling a pump that generates negative pressure within the drainage tube. When operating continuously, the speed of the pump can be controlled by the monitor / controller to maintain an appropriate pressure range within the system.

[0385] In some embodiments, a flow meter or flow sensor may be incorporated into the system. For example, a flow meter can be added to the vent tube to monitor the air flow and more appropriately control the air lock elimination function. The flow rate is detected by the flow meter and the signal is transmitted to the controller. In some embodiments, the flow sensor or meter may be provided elsewhere in the system, such as within or near the reservoir / cassette.

[0386] For example, if there is an air lock in the drainage line, air will not flow from the vent tube. This information can be used by the control unit, for example, to initiate an air lock removal cycle by applying negative pressure to the cassette and the drainage line. If there is air flow in the vent tube, the control unit may determine that there is no air lock. In an embodiment where there is also a flow sensor in the reservoir / cassette, the control unit may be able to determine where there is a blockage in the system. For example, it may be possible to determine whether the drainage tube, the vent tube, or the cassette is clogged. For example, the control unit can determine whether the user has forgotten to remove the clamp on the drainage line, and the control unit can display this to the user. The control unit can detect the flow rate when a vacuum is drawn by the vacuum pump. By detecting the flow rate inside the cassette, the blocked location can be identified. If the flow rate is low, it indicates a blockage closer to the cassette, and if the flow rate is high (but less than the assumed cut-off value), it indicates a blockage farther from the cassette.

[0387] Similar to any of the embodiments disclosed herein, an overflow barrier or overflow path may be incorporated into the reservoir / cassette.

[0388] Some embodiments of the sensing Foley system may incorporate comprehensive "smart" sensing that includes any of the sensing types disclosed herein. For example, a "smart" Foley catheter sensing system can include the following.

[0389] - Oxygen saturation by a sensing mechanism such as pulse oximetry,

[0390] - Electrocardiogram, i.e., via electrodes in contact with the urethra, bladder, and skin,

[0391] - Urine parameters by a visible or other wavelength camera including spectroscopy,

[0392] - Measuring the capacitance of at least one of tissue and urine via an electrode that contacts the urethra, bladder, skin, or an electrode disposed within a reservoir / cassette that contacts urine.

[0393] - Measuring the conductivity of tissue and / or urine via an electrode that contacts the urethra, bladder, skin, or an electrode disposed within a reservoir / cassette that contacts urine.

[0394] - Chemical analysis of urine by at least one of a catheter and a drainage tube, or a sensor within a monitor / cassette. Examples include albumin, bilirubin, red blood cells, hemoglobin, myoglobin, hemolysis, urine pH, bile, urea, sodium, potassium, calcium, creatinine, etc.

[0395] - Heart rate

[0396] - Respiratory rate

[0397] - Blood pressure

[0398] - Sleep analysis (i.e., at least one of duration and quality) - This can be achieved by analyzing blood pressure, respiratory rate, heart rate, IAP, etc.

[0399] - Central venous pressure.

[0400] It should be noted that the elements disclosed in connection with any embodiment herein can be used in any other embodiment disclosed herein.

Claims

1. A pump mechanism fluidly connectable to a portion of a drainage line at a first end, A bypass lumen fluidly connected along the drainage line at a first bypass end located proximal to the pump mechanism and a second bypass end located distal to the pump mechanism, A ventilation mechanism having a one-way valve and connectable to communicate fluidly with a drainage catheter and the drainage line at a first end, Comprising, The pump mechanism is configured to generate a negative pressure in the drainage line when communicating with the drainage line, The one-way valve is configured to open to the environment when the ventilation mechanism is connected at the first end and the drainage line is at a pressure lower than the ambient pressure so that an air lock is not formed in the drainage line, a fluid drainage system.

2. The system according to claim 1, further comprising the drainage line fluidly connected to the pump mechanism.

3. The system according to claim 1, further comprising the drainage catheter comprising a Foley catheter.

4. The system according to claim 1, wherein the ventilation mechanism is connectable to communicate fluidly with the drainage line via a sampling port of the drainage system, including within the drainage line, as part of a portion of the drainage catheter, or between the drainage catheter and the drainage line, at the first end.

5. The system according to claim 1, wherein the ventilation mechanism is connectable to communicate fluidly with the proximal end of the drainage catheter at the first end and further connectable to communicate fluidly with the distal end of the drainage line at a second end.

6. The system according to claim 1, wherein the pump mechanism is configured to generate the negative pressure periodically in the drainage line.

7. The system according to claim 1, wherein the pump mechanism is configured to generate the negative pressure continuously in the drainage line.

8. The system according to claim 1, wherein the pump mechanism is directly connectable to the drainage line.

9. The system according to claim 1, wherein the pump mechanism comprises a peristaltic pump.

10. The system according to claim 1, wherein the pump mechanism comprises a positive displacement pump.

11. The system according to claim 1, wherein the pump mechanism comprises a centrifugal pump.

12. The system according to claim 1, wherein the pump mechanism is fluidly coupled to the portion of the drainage line at a first end and is fluidly coupled to a reservoir at a second end.

13. The system according to claim 1, further comprising a fluid flow meter configured to communicate with the drainage line.

14. A method of draining body fluid from a subject, comprising: providing a pump mechanism connectable to a portion of a drainage line; providing a drainage catheter and a ventilation mechanism fluidly connectable to the drainage line; generating a negative pressure in the drainage line by the pump mechanism; receiving body fluid from the drainage catheter into the drainage line; opening a one-way valve fluidly coupled to the drainage line and proximate to the drainage catheter when the drainage line is at a pressure lower than ambient pressure, such that air from the environment is introduced through the one-way valve; suppressing the occurrence of an air lock in the drainage line via a bypass lumen fluidly connected along the drainage line at a first bypass end located proximal to the pump mechanism and a second bypass end located distal to the pump mechanism; A method of draining body fluid from a subject, comprising the steps above.

15. The method according to claim 14, wherein the drainage catheter comprises a Foley catheter.

16. The method according to claim 14, wherein the step of providing the ventilation mechanism further comprises connecting the ventilation mechanism at a first end to be in fluid communication with the drainage line via a sampling port of the drainage system, which is within the drainage line, as part of the drainage catheter, or between the drainage catheter and the drainage line.

17. The method according to claim 14, wherein the step of providing the ventilation mechanism further comprises connecting the ventilation mechanism at a first end to be in fluid communication with the proximal end of the drainage catheter and at a second end to be in fluid communication with the distal end of the drainage line.

18. The method according to claim 14, wherein the step of forming the negative pressure includes the step of periodically generating the negative pressure in the drainage line.

19. The method according to claim 14, wherein the step of forming the negative pressure includes the step of continuously generating the negative pressure in the drainage line.

20. The method according to claim 14, wherein the pump mechanism comprises a peristaltic pump.

21. The method according to claim 14, wherein the pump mechanism comprises a positive displacement pump.

22. The method according to claim 14, wherein the pump mechanism comprises a centrifugal pump.

23. The method according to claim 14, further comprising the step of receiving the body fluid at a first end of the pump mechanism and discharging the body fluid to a reservoir that is fluidly connected at a second end of the pump mechanism.

24. The method according to claim 14, further comprising the step of measuring a fluid flow rate via a fluid flow meter in communication with the drainage line.

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