System for excretion and analysis of body fluids and assessment of health

Abstract

To provide a system for draining and analyzing body fluid and for assessing health conditions.SOLUTION: A system comprise: a drainage tube in fluid communication with an opening near a distal end of a catheter or at a distal end; a pump in fluid communication with the drainage tube and configured to apply a negative pressure to the drainage tube; a valve configured for a unidirectional flow and in fluid communication with the drainage tube; a pressure interface configured to be in fluid communication with the drainage tube; and a control part communicating with the pump. The control part is configured to actuate the pump to apply the negative pressure for clearing an airlock from the drainage tube, to monitor a quantity of urine from the patient over a predetermined period of time and to determine an intra-abdominal pressure on the basis of a measurement value received from a pressure interface, and may determine a risk of acute kidney injury on the basis of a change in a quantity of urine and a change in a pressure of the intra-abdominal pressure.SELECTED DRAWING: Figure 10A

Description

Technical Field

[0001] The present invention relates to the field of medical devices. In particular, the present invention relates to a device for assisting in emptying the bladder, a device for measuring various urine parameters such as urine volume, and oxygen tension, urine conductivity and urine specific gravity, a device for monitoring kidney function, a device for analyzing urine parameters including urine volume including the presence or absence of infection, and a device for performing at least one of tracking and controlling body fluid administration. The present invention further relates to a medical device capable of detecting physiological data based on a sensor incorporated in a catheter configured to be present in any of the urinary tract, gastrointestinal tract, rectal position, preperitoneal, pleural space, or other body cavity. Incorporation by reference

[0002] All publications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Background Art

[0003] It is estimated that 10% of inpatients and long-term convalescent patients receive indwelling urethral catheters. Most critically ill patients receive one catheter, and it is a daily routine procedure to monitor urine output every hour in the ICU. The amount of urine output is an indicator of the state of body fluids and kidney function. However, many sources of error can cause incorrect measurement of this important indicator.

[0004] The most common device used for bladder drainage is the Foley catheter. Since its introduction, the configuration of the flexible tube with a fixation balloon and small holes has changed little, allowing urine to drain through the central lumen. However, with the current configuration of Foley catheters, it has been found that a large residual volume may remain in the bladder, for example, exceeding 50 mL in supine patients. 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 found in the drainage tube connecting the Foley catheter to the drainage bag and in other locations within the drainage system.

[0005] Residual urine occurs in the bladder and drainage tube because large air bubbles (air locks) form in the tube, preventing the flow of urine from the bladder to the drainage bag. As a result, it is a routine procedure for nurses to manipulate the drainage tube before measuring urine output, which helps to empty the drainage tube. In the ICU, where measurements are taken at one-hour intervals, this is a very repetitive and inaccurate task. There is a need for more accurate automated urine output measurement.

[0006] In addition, there are opportunities within the urine collection system to measure and analyze urine parameters.

[0007] In addition to improving urine output measurement and urine parameter analysis, the drainage catheter itself offers untapped opportunities to detect, collect, and analyze additional patient parameters.

[0008] Also, many types of medical devices are configured to control at least one of patient treatment and maintenance. For example, among these, a respirator can control a patient's breathing rate, volume, and / or gas mixture. An IV (intravenous delivery) can deliver fluids such as drugs and / or other substances to a patient. Other devices include those that can deliver drugs or perform other operations. Such types of medical devices can be strictly controlled by various settings and the like. A nurse or other practitioner can check various patient parameters and adjust the settings of the medical treatment device accordingly. There is a need for a control unit that uses patient parameters automatically or semi-automatically to control the settings of the medical treatment device.

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] A Foley catheter that is widespread, low-cost, and can be easily installed by medical staff can be used as a means to derive important diagnostic information by improving the Foley catheter or adding functionality to the Foley catheter. The technology disclosed herein delivers highly elucidated, previously unavailable diagnostic information that may be obtainable from a Foley catheter having intra-abdominal pressure (and other) sensing capabilities.

[0011] In addition, the development of air locks has been found to significantly distort the measured value of intra-abdominal pressure. In addition, a non-empty bladder can also have an adverse effect on the measured pressure value within the bladder. The technology disclosed herein also provides for the detection and removal of air locks in intra-abdominal pressure measurements or other settings, as well as more complete bladder drainage.

Means for Solving the Problems

[0012] The technology disclosed herein attempts to more effectively drain the bladder, prevent the formation of air locks within the drainage tube, eliminate air locks in the process, and improve the accuracy of measuring urine volume in an automated manner. The disclosed technology also contemplates incorporating additional measurements of urine, including oxygen tension, conductance, and specific gravity, gas pressure, turbidity, infection, sediment, etc., to improve the monitoring of fluid status, renal function, and other important patient parameters.

[0013] The disclosed technology also relates to a Foley-type catheter for detecting physiological data from at least one of a patient's bladder and urinary tract, where the physiological data includes, in particular, data collected by conversion into a signal suitable for high-fidelity pressure detection and processing. In some embodiments, the pressure-sensing Foley-type catheter may further be enabled to detect temperature and clinically important analytes. Examples of physiological parameters (temporal measurements and trends of values over time) that a sensing Foley catheter system can measure include urine volume, respiratory rate, heart rate, heart rate variability, stroke volume, stroke volume variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas content, pulse transit time, pulmonary blood volume variability, body temperature, blood volume, and other patient parameters.

[0014] A drainage assembly configured to prevent the accumulation of negative pressure according to one embodiment may generally include an elongate catheter having a first end configured to be inserted into a body cavity. The catheter may have at least one opening near or at the first end in fluid communication with a catheter lumen formed therein, a drainage lumen in fluid communication with a 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 such that the valve moves to an open position. Also, a vent may be disposed in fluid communication with the valve, the ventilation mechanism being configured to suppress wetting of the vent from fluid within the drainage lumen; and a control unit in communication with the reservoir is configured to determine the amount of fluid collected within the reservoir.

[0015] In another embodiment, 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 may have 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 ventilation from the fluid in the drainage lumen. The control unit may be communicable with the reservoir and is configured to determine the amount of fluid collected in the reservoir and may further include a valve configurable between a closed position and an open position. The valve is configured to move from the closed position to the open position when a first pressure level applied to the valve drops to a second pressure level.

[0016] Certain patient parameters that can be measured and / or determined by the disclosed technology are affected by and / or affect the treatment of a patient by a medical treatment device. For example, a patient's urine output, respiratory rate, heart rate, stroke volume, stroke volume variability, intra-abdominal pressure (IAP), tissue oxygenation, tissue gas volume, body temperature, blood volume, and other patient parameters are affected by and / or affect a medical procedure. Examples of medical procedures that can be controlled by a medical device include respiratory rate and content controlled by a respirator, IV rate and content controlled by an IV drip controller, drug delivery controlled by a drug delivery device or an IV controller, urine output controlled by a urine pump, ascites volume controlled by a drain pump, and other procedures controlled by other medical treatment devices.

[0017] A system for analyzing body fluids according to one embodiment generally has an expandable balloon disposed near or at the distal end of a catheter, and further defines one or more openings proximate to the balloon. The system includes an elongate catheter, a ventilation mechanism coupled to the proximal end of the catheter, a ventilation mechanism configured to allow air to pass 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 urine output received into the reservoir from the patient and determine the patient's intra-abdominal pressure based in part on changes in the pressure within the balloon. The control unit is further configured to store patient data.

[0018] In one exemplary method for analyzing one or more body parameters from a patient, the method generally includes disposing an elongate catheter having an expandable balloon disposed near or at the distal end thereof within a body cavity that is at least partially filled with body fluid, receiving urine through one or more openings defined along the catheter proximate to the balloon, further receiving body fluid into a reservoir disposed external to the body cavity and in fluid communication with the one or more openings via a fluid lumen, venting air through a ventilation mechanism in communication with the fluid lumen when a negative pressure is applied to the fluid lumen, analyzing the amount of urine received into the reservoir via a control unit programmed to control the negative pressure applied to the ventilation mechanism, determining the patient's intra-abdominal pressure based in part on changes in the pressure within the balloon, and storing one or more parameters of patient data via the control unit.

[0019] Some embodiments of the sensing Foley catheter system include a loop control unit that receives one or more data fragments 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 patient parameters, a medical treatment device, or both.

[0020] A pressure measurement balloon on a catheter, as disclosed in Patent Document 1 (International Patent Application No. PCT / US14 / 44565) whose invention name is a sensing Foley catheter, is an example of a device that measures patient parameters (which is hereby incorporated by reference in its entirety herein). Additional embodiments are disclosed herein. The sensing Foley catheter system includes at least one of a pressure measurement balloon and a plurality of other sensors, and further has the ability to measure urine volume and contents for determining patient parameters such as urine output rate, IAP, respiratory rate, heart rate, stroke volume, tissue oxygenation, urine composition, body temperature, and other patient parameters.

[0021] Other parameters that can be measured and / or determined via a sensing Foley catheter include urine specific gravity and pulse pressure variation. These parameters may be used to assist in the control of medical treatment devices such as ventilators and / or infusion and / or hydration devices.

[0022] Urine specific gravity is an index representing 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 dehydration or other conditions. A measurement value lower than this may indicate fluid overload or other conditions. The measurement may be performed by a plurality of sensors on the sensing Foley catheter. The measurement result may indicate an increase (in the case of dehydration) or a decrease (in the case of fluid overload) in the patient's infusion volume. Also, the measurement result may indicate changes in ventilation parameters, injection of drugs, etc.

[0023] Pulse pressure variation can be a predictor of fluid responsiveness to a medical treatment device such as at least one of a ventilator and a fluid infusion device. A sensing Foley catheter can record a pressure waveform, and a control unit can identify a maximum pressure pulse and a minimum pressure pulse that coincide with the respiratory cycle. The control unit can calculate the variation of the pulse pressure. Pulse pressure variation helps to determine whether a particular patient will respond to fluid therapy. Pulse pressure variation can also be used by the control unit to control treatment in a feedback loop. When the pulse pressure variation is large, the patient may require more fluid. When the pulse pressure variation is small, less fluid may be required.

[0024] A sensing Foley catheter system can measure cardiac activity via pressure sensing within the bladder. The sensing Foley catheter can measure not only cardiac activity but also respiratory activity, and since the frequencies of the patient's respiratory rate and heart rate may be similar to each other, the patient's respiratory measurement may distort the cardiac measurement. To overcome this problem, in some embodiments of the control unit, the ventilator may be temporarily stopped at the end of one or more inspiration points and / or the ventilator may be temporarily stopped at the end of one or more expiration points (for only a few seconds each time, for example, between 1 and 3 seconds, or for example, between 1 and 4 seconds) so that the cardiac waveform can be captured without respiratory distortion. By capturing the detailed cardiac waveform in this way, the control unit can determine the stroke volume variation (SVV) useful for sepsis detection and prevention of fluid overload. As an alternative embodiment, the patient may be asked to hold their breath at at least one of the inspiration point and the expiration point.

[0025] In another embodiment, the catheter system generally may include 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 disposed in-line and proximal to the barb with respect to the vent tube, the control unit may communicate with the one-way valve, and the control unit may be programmed to apply a negative pressure to the drainage tube, whereby the one-way valve is opened and fluid passes through the vent tube.

[0026] In another embodiment, one method for draining fluid may generally include disposing 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 be activated in a situation where the one-way valve is disposed in-line with the vent tube and in fluid communication with the barb, and the one-way valve is further disposed at a position proximal to the barb. A negative pressure is applied to the drainage tube, whereby the one-way valve is opened and fluid passes through the vent tube.

[0027] In another embodiment, a system for evaluating a patient's health condition generally comprises 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 configured to be in fluid communication with the drainage tube and apply a negative pressure to the drainage tube, and a valve configured to flow in one direction and be in fluid communication with the drainage tube. The control unit may communicate with the pump, and the control unit is configured to operate the pump to apply a negative pressure for eliminating 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 also over 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) when the urine volume below the urine volume threshold exceeds the second predetermined period.

[0028] In another embodiment, a method for evaluating a patient's health generally comprises receiving urine output from the patient via a catheter having at least one opening near or at the distal end, applying a negative pressure to a drainage tube in fluid communication with the at least one opening until the air lock is eliminated from the drainage tube, monitoring the urine output via a control unit over a first predetermined period exceeding a urine output threshold, and further monitoring the urine output over a second predetermined period below the urine output threshold. Further, the method may include determining the risk of AKI when the urine volume less than the urine volume threshold exceeds a second predetermined period.

Brief Description of the Drawings

[0029]

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[0030] The novel features of the present invention are listed. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description that defines exemplary embodiments in which the principles of the present invention are utilized, and the accompanying drawings.

[0031] Preferred embodiments of the present invention are described in detail herein. However, alternative embodiments of various elements of the 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.

[0032] Sensing Foley catheter

[0033] Figure 1 is a diagram showing a sensing Foley catheter and some of its elements according to one embodiment. The catheter can be understood to have various parts according to its location, such as a proximal part that remains outside the subject when the catheter is inserted into a human subject, a central part that stays in the urethra, and a distal part that stays in the urethra bladder.

[0034] For example, various internal lumens such as an air lumen or a fluid lumen that communicates with the bladder retention balloon 104 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. Also, the urine drainage lumen may be connected to a urine drainage tube that conveys urine to a urine collection container. The urine drainage tube may be separate from the sensing Foley catheter or may be provided integrally with the sensing Foley catheter. In some embodiments, the drainage tube lumen and the distal side opening within the bladder also function as an infusion conduit into which a pharmaceutically active agent may be infused, or a heated or cooled fluid may be infused. One or more analyte sensors (not shown) or one or more temperature sensors (not shown) may be disposed on the catheter either in the urethral portion or the bladder indwelling portion of the catheter. Electrical fiber leads or optical fiber leads may be disposed within a lumen that enables communication of a sensing signal between a sensor disposed distally and the proximal portion of the catheter, and thereafter enables further communication to a data processing device or a control unit.

[0035] 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 the pressure sensing membrane can be understood to constitute a pressure interface having a surface facing distally that is exposed to the pressure within the bladder and a surface facing proximally that is 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 the 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 constitute a dedicated lumen or a shared lumen.

[0036] In some embodiments, the temperature sensor may be present at or near the distal end of the catheter. The temperature port 110 may include a temperature communication wire 112 that connects the temperature sensor to a display, a connector, and / or a control unit.

[0037] FIG. 1 shows the proximal end of a catheter consisting of a plurality of individual ports, but note that some or all of the ports may be integrally provided in a single port, or alternatively, may be integrally provided in a urine drainage line extending to a urine drainage system and / or a control unit. At least one of the other lumens and ports may also be present.

[0038] Pressure-based physiological parameters that the Foley catheter system may detect and / or determine via a control unit based on detected parameters may, by way of example, include intraperitoneal pressure, respiratory rate, and heart rate, relative pulmonary ventilation profile, cardiac output, relative cardiac output, and absolute stroke volume. In some embodiments of the Foley catheter, it may further comprise any of a temperature sensor, one or more analyte sensors, electrodes, and a paired light source and sensor. In embodiments that further comprise as described above, other forms of physiological data such as, for example, blood pressure, oxygen saturation, pulse oximetry, EKG, and capillary refill pressure can be provided.

[0039] Embodiments of the detection Foley catheter can detect any one or more of a plurality of clinically relevant parameters, such as those included in the following examples, namely urine pH, urinary urea content, urinary nitrate content, respiratory rate, heart rate, perfusion pressure of the bladder wall or urethral wall, temperature within the bladder or urethra, electrocardiogram via sensors on the bladder wall or urethra, respiratory volume, respiratory pressure, peritoneal pressure, urine glucose, blood glucose via the urethral mucosa and / or bladder mucosa, urine protein, urinary hemoglobin, and blood pressure. In some embodiments, the catheter can detect multiple parameters, but in some embodiments, it may be limited to only the number of single parameters for focused applications (e.g., respiratory rate of a patient in respiratory distress).

[0040] The disclosed technology can capture a high-resolution time-series profile of peritoneal pressure from within the bladder (pressure as a function of time), which can be converted and processed into individual pressure profiles that can be assigned to specific physiological sources, including peritoneal pressure, respiratory rate, and heart rate. As provided by this technology, by tracking the pressure profile at a sufficiently rapid sampling rate, the pressure profile can be further decomposed and / or analyzed into relative pulmonary ventilation volume, cardiac output, relative cardiac output, and absolute stroke volume.

[0041] Accordingly, aspects of the disclosed technology relate to the fidelity and resolution of the pressure signal generated in response to changes in pressure within the bladder, such changes reflecting the pressure profile within the peritoneal cavity, and such pressure profiles including the cumulative input from the physiological sources described above. Aspects of the technology further relate to the fidelity and resolution of the transmission of the pressure signal to highly resolved electrical signals. Aspects of the technology are further related to processing the entire electrical signal profile, which is a surrogate for the pressure profile within the peritoneal cavity, into component profiles that can be assigned to physiological sources.

[0042] The sensitivity of the inflated balloon as a pressure sensor is such that a part of the differential pressure across the balloon membrane as a baseline condition functions. The balloon has the highest sensitivity to pressure when the differential pressure at the baseline is close to zero. As the differential pressure at the baseline increases, the sensitivity of the pressure sensing balloon decreases. Therefore, according to the disclosed technology, an automatic priming method is provided that minimizes the differential pressure while maintaining the balloon in an inflated state.

[0043] To effectively capture the physiological pressure profile, it is necessary to sample the profile at a rate sufficient to resolve the characteristic frequency of the profile changes. This consideration is based on the Nyquist-Shannon sampling theorem, which states that to resolve an event occurring at a frequency of B cycles per second, a sampling frequency of at least 2B samples per second is required. Applied to the physiological pressure cycle, for example, a heart rate of 70 beats per minute requires a sampling rate of at least 140 samples per minute to effectively capture the cycle. This relationship forms the basis of an aspect of the disclosed technology that defines the sampling rates particularly required to capture physiological pressure cycles such as relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute stroke volume.

[0044] In an embodiment of the present technology, a pressure interface is included, such as represented by a balloon having either a compliant or non-compliant membrane.

[0045] An expandable pressure sensing balloon may assume one or more of at least two basic forms, compliant or non-compliant, for each embodiment of the technology. In a compliant balloon type, generally exemplified by conventional party balloons, the pressure sensing balloon is formed from, or includes, a compliant membrane. Thus, the surface area of the membrane expands or contracts as a function of the expansion of the balloon. The compliant nature of the membrane determines various characteristics of the balloon at various levels 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. As the balloon expands from its minimum volume to its maximum volume, the membrane of the balloon maintains a predetermined level of tension. Within the range of the compliant nature of the compliant membrane, the volume expands due to the increase in pressure during inflation. The balloon is considered to be partially compliant in that its shape is adapted to the spatial constraints that may be encountered during expansion or inflation, but the balloon has a preferred or inherent shape that would preclude the level of compliance or conformity of shape exhibited by a non-compliant balloon.

[0046] In a non-compliant balloon, the inflatable pressure sensing balloon is formed of, or includes, a non-compliant membrane, or a substantially non-compliant membrane. Thus, the surface area of the membrane does not expand or contract depending on the degree of inflation / pressurization of the balloon. Non-compliant pressure sensing balloons are generally exemplified by conventional Mylar (registered trademark) balloons. The non-compliance of the membrane determines various characteristics of the balloon at various inflation levels overall. As the balloon inflates from its minimum volume to near its maximum volume, the membrane of the balloon becomes flexible and sags. The inflation of a non-flexible balloon occurs by smoothing out the wrinkles and folds of the membrane outward. The contraction or compression of a non-flexible balloon generally occurs by inward-facing wrinkles or folds. When a non-compliant balloon is fully inflated (or substantially inflated) without being in a restricted space, the balloon assumes a preferred or characteristic shape as determined by the shape of the balloon's membrane or fabric. However, in a partially inflated state, the balloon is overall very flexible and conformable, assuming a wide range of shapes as required by the restricted space.

[0047] An inflatable pressure sensing balloon according to one embodiment of the present technology may also include characteristics of both of the two basic forms of compliance and non-compliance. In these embodiments, the membrane may include compliant regions and non-compliant regions. This hybrid type of balloon will behave overall so as to elicit the behavioral aspects of both compliant and non-compliant balloons as described above. Further, a compliant balloon may be formed of a membrane that is not of uniform composition or thickness. In such embodiments, regions of different thickness or composition may have various degrees of compliance, affecting the behavior of these regions during inflation of the balloon. In still other embodiments, the compliance of the membrane may have a bias or polarity that tends to allow compliance in one or more directions and tends not to allow compliance in one or more other directions.

[0048] Embodiments of the sensing Foley catheter include devices that utilize very small pressure lumens for air transmission. Pressure readings are measured using lumen inner diameters of 3 mm, 1 mm, and 0.5 mm. When the air lumen diameter was reduced from 3 mm to 1 mm and 0.5 mm, little signal degradation was seen.

[0049] These data indicate the suitability of using embodiments of the pressure transmission system in small-diameter pediatric catheters down to a small size of 4F. In this embodiment, similarly, the tip of the catheter can be made lower profile than the rest of the catheter so that it can consistently be made smaller in diameter even with the addition of a pressure sensing balloon. Thus, the catheter of the present invention is uniquely suitable for pediatric applications where there is a critical need for a more appropriate and less invasive monitoring method. In another embodiment, the holding balloon itself can be used as the pressure balloon to minimize the number of lumens required. In one embodiment, the holding balloon is used in its fully inflated state and is used only to track the macro trends of IAP. In another embodiment, the holding balloon is inflated only slightly to enhance balloon sensitivity to small changes in pressure. In this embodiment, minute parameters such as heart rate, relative stroke volume, relative cardiac output, respiratory rate, and relative tidal volume can be measured more precisely. Also, by making the pressure lumen smaller, more space in the catheter can be secured for other technologies such as sensors.

[0050] In an embodiment of a sensing Foley catheter in which the retention balloon is used as a pressure balloon, the pressure measured within the retention balloon is offset by the pressure necessary to just inflate a balloon of a size sufficient for the retention balloon to function as a retention balloon. As a result, it is necessary to subtract the inflation pressure and the pressure due to the retention balloon being in contact with the inner surface of the bladder from the pressure measurement. In this way, smaller pressure changes may be tracked as well as those measured by individual pressure balloons. The offset of the inflation pressure may be determined by measuring the pressure within the retention balloon when the retention balloon is first inserted into the patient's body, or by measuring the inflation pressure of the retention balloon outside of the patient's body, or by other means. The retention balloon may be filled with fluid, air, or any other suitable gas.

[0051] Embodiments of the disclosed technology may include embodiments in which the pressure sensor is a mechanical pressure sensor, e.g., using optical fiber, strain gauge, magnetic, resonance, and / or other suitable technologies.

[0052] FIG. 2 is a diagram showing an example of respiration rate detection data from a human subject provided by a sensing Foley catheter system according to an embodiment. During this test period, the subject performs the following respiration sequence: (1) hold breath at the end of exhalation, (2) Valsalva, (3) hyperventilation, (4) Valsalva, (5) hold breath at the end of exhalation.

[0053] FIG. 3 is a diagram showing a detailed portion of a normal respiration period in a respiration profile similar to that of FIG. 2. Note that the pressure curve clearly shows the peaks of respiration and thus the respiration rate can be determined, and the peaks of the heart rate can be determined and thus the heart rate can be determined.

[0054] FIG. 4 shows an example of heart rate and relative cardiac output detection data from a human subject, as provided by a sensing Foley catheter system according to one embodiment, and shows an electrocardiogram trace measured simultaneously and independently. This graph clearly shows that the peak of the heart rate, as measured by the sensing Foley catheter, coincides with the heart rate.

[0055] FIG. 5 is a diagram showing data related to the detection of relative cardiac output in a human leg-lifting exercise in which cardiac output increases, as indicated by an increase in the amplitude of the cardiac pulse.

[0056] The data shown in FIGS. 6 and 7 were obtained from studies conducted on Yorkshire pigs under an IACUC-approved protocol. FIG. 6 is a diagram showing an example of peritoneal sensing data focused on the respiratory rate from a pig, as provided by a sensing Foley catheter system according to one embodiment. FIG. 7 shows an example of a pig study demonstrating the ability of a sensing Foley catheter system according to one embodiment for detecting intra-abdominal hypertension. In this study, access to the peritoneal cavity was made using a 5 mm Tenamian trocar. The trocar was then attached to a bag of 5 L of lactated Ringer's solution via a peristaltic pump, and the solution was infused at a rate of approximately 1 L per minute. The fluid flow was interrupted when a pressure of approximately 20 mmHg was obtained and when there was no net fluid flow, either intra- or extra-cavity.

[0057] FIG. 8 schematically arranges the intra-abdominal pressure, respiratory blood pressure wave pressure, and cardiac pressure 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 it can be seen that different sectors are occupied when various physiological pressure-related parameters are arranged in this way. Embodiments of the methods as disclosed herein can decompose a single overall pressure profile over time into distinct sub-profiles according to their physiological origin by virtue of both these pressure profiles and / or frequency profiles being distinct. The measurement of intra-abdominal pressure may be analyzed in a frequency range of about 0 Hz to about 0.5 Hz. The measurement of respiratory pressure may be analyzed in a frequency range of about 0.25 Hz to about 0.75 Hz. The cardiac pressure measurement may be analyzed in a frequency range of about 0.75 Hz to about 3.0 Hz. The intra-abdominal pressure measurement may be analyzed in an amplitude range of about 5 mmHg to about 30 mmHg. The respiratory pressure measurement may be analyzed in an amplitude range of about 0.5 mmHg to about 5 mmHg. The cardiac pressure measurement may be analyzed in an amplitude range of about 0 mmHg to about 0.5 mmHg. The sampling frequency, i.e., the frequency at which the pressure measurement is made, is preferably about twice the resolution frequency. For example, the sampling frequency may 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.

[0058] FIG. 9 is a flow diagram of a method for monitoring the pressure dynamically generated as a wave whose frequency and amplitude vary within the abdomen as sensed from the bladder according to one embodiment. A high-fidelity pressure profile is generated via a pressure interface and sent proximally via a fluid column. More proximally, a pressure transducer converts the high-fidelity pressure wave into a high-fidelity electrical signal that conveys the frequency and amplitude of the pressure. The generated high-fidelity electrical signal is processed by a control unit to generate a data subset that reflects components within the overall pressure profile, such subsets being attributable to specific physiological sources such as peritoneal pressure, respiratory rate, heart rate, relative cardiac output, patient movement and activity, etc.

[0059] Detection Foley catheter system

[0060] FIG. 10A is a diagram showing a detection Foley catheter according to an embodiment for use in connection with an airlock elimination ring mechanism and a fluid collection and analysis system according to an embodiment. Both urine drainage and pressure measurement are effective by eliminating or reducing the airlock in the urine drainage line.

[0061] The detection Foley catheter 1000 is similar to the detection Foley catheter shown in FIG. 1. The detection Foley catheter is shown to be used in the bladder 1014. Note that some of the ports at the proximal end of the catheter shown in FIG. 1 are coupled in the embodiment shown in FIG. 10A. Also shown here is a urine drainage tube 1001. The urine drainage tube may be combined with the detection Foley catheter or may be an individual member. At least one of the urine drainage tube 1001 and the detection Foley catheter may include a vent valve (or valve) 1016, or the vent valve may be an individual member. The airlock 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 airlock 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, and the airlock elimination mechanism and the fluid collection and analysis system 1002 is also referred to herein as a detection Foley catheter system. The detection Foley catheter, the urine drainage line, and the reservoir / cassette may be disposable or 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.

[0062] The vent valve 1016 may include one or more vents 1006, similar to the urine sampling port 1004. In this embodiment, the vent 1006 is preferably formed from a membrane that allows gas to permeate but not liquid, such as a hydrophobic membrane. As an example of such an exemplary vent, other materials may be used, but examples include PTFE (polytetrafluoroethylene), ePTFE (expanded PTFE), or Versapor® (manufactured by Pall Corporation, Port Washington, NY) membranes. The vent allows air to enter the system when a negative pressure is applied to the drainage tube and also allows air to exit when an air lock occurs in the drainage tube and a positive pressure is generated. Such a mechanism prevents, for example, aspiration trauma to the bladder wall. The vent 1006 may incorporate a one-way valve that prevents air from exiting the drainage line or, alternatively, a one-way valve that prevents air from entering the drainage line. In a preferred embodiment, the one-way valve is used to prevent air from exiting the drainage line but allows air to enter the drainage line via the vent 1006. Thus, the valve also prevents urine from contacting the vent 1006.

[0063] 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 also communicates with a temperature sensor (not shown) within the sensing Foley catheter and a temperature connector port 1024 within the control unit. The urine lumen 1012 is in fluid communication with one or more openings 1006 and a urine reservoir or cassette 1022.

[0064] The disposable measurement container, urine collection container, chamber, or cassette component 1022 is configured to fit into a cassette mount, base, or control unit 1018 and interface with components 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 member. The pump is configured to generate a vacuum inside the cassette member and subsequently transfer it to the urine drainage lumen of the drainage line. Preferably, the urine collection container / cassette is rigid so as to maintain a constant volume when the pump applies negative pressure. The level of negative pressure applied may be monitored by a pressure sensor. During the breakage of the air lock, the pressure follows a marked curve as shown in FIG. 59. When suction is applied, the pressure drops and finally reaches an inflection point when the urine meniscus passes the lowest point of the drainage tube. At this point, since less suction is required to continue breaking the air lock, the output of the pump can be reduced to minimize the amount of suction transmitted to the bladder after the air lock is completely broken. In a large container without this pressure sensing function, for example, after the air lock is broken and before the container equilibrates to the atmosphere, substantial negative pressure will be transmitted 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 a body fluid such as urine based on the pressure exerted on a pressure measuring device which may be a pressure transducer. Also, the ultrasonic transducer interface 1130 provides urine volume measurement. The ultrasonic measurement may be used in combination with the pressure measurement or either one may be used to measure the volume amount of a body fluid such as urine. The active pinch valve 1132 is configured to connect to the outflow tube of the cassette. The pinch valve is for controlling to empty the cassette container and is controlled by the control unit to release urine / fluid when the urine volume reaches a predetermined volume in the cassette as measured by the pressure measurement and / or ultrasonic measurement.Measure the amount of urine in the cassette, and when it reaches a certain amount, empty the urine in the cassette into the urine drainage bag 1020 via the pinch valve. For example, when the amount of urine in the cassette reaches about 50 mL, the cassette may be emptied. Alternatively, when the amount of urine in the cassette reaches about 40 mL, the cassette may be emptied. Alternatively, when the amount of urine in the cassette reaches about 30 mL, the cassette may be emptied. Alternatively, when the amount of urine in the cassette reaches about 20 mL, the cassette may be emptied. Alternatively, when the amount of urine in the cassette reaches about 10 mL, the cassette may be emptied. In this way, the urine output can be accurately measured over time.

[0065] In some embodiments, a capacitive micromachined ultrasonic transducer (CMUT) may be used to measure the amount of urine in the cassette. This can realize a less expensive ultrasonic transducer that can cover the entire bottom of the cassette and / or one or more sides of the cassette. This may eliminate the problem of the cassette tilt.

[0066] Emptying the cassette may be increased or accelerated by pressurizing the cassette during the emptying process.

[0067] Alternatively, the control unit may measure the amount of urine in the cassette immediately before emptying by using the time set between emptyings of the cassette. Alternatively, the control unit may empty the cassette when an event such as the air lock being released due to the operation of the pump occurs. For example, the control unit may periodically set an air lock release cycle, then measure the amount of urine in the cassette, and then empty the cassette.

[0068] For example, the control unit may control the pinch valve to empty the reservoir / cassette when the urine volume reaches about 50 ml. Alternatively, the control unit may control the pinch valve to empty the reservoir / cassette every hour after measuring the urine volume in the cassette. Alternatively, the control unit may control the pinch valve to empty the reservoir / cassette during or after a urine drainage event such as the operation of the pump. Alternatively, the control unit may control the pinch valve to empty the reservoir / cassette using a combination of these triggers.

[0069] In addition to, or instead of, pressure and / or ultrasound, other techniques for measuring urine volume may be used, including pressure-based techniques, resistance-based techniques, capacitance-based techniques, ultrasound-based techniques, or optical-based techniques. Two or more techniques may be used to compare the measured values with each other to improve the accuracy of volume measurement. Two or more volume measurements performed by one or more techniques may be used for more accurate urine volume measurement, for redundancy, for backup, or in combination with each other.

[0070] For example, a camera may be used to recognize a fluid / air interface and measure the fluid level in a reservoir. Subsequently, the known dimensions of the reservoir can be used by the control unit to calculate the fluid volume. Also, the camera can be used to identify the fluid / air interface and the edges of the reservoir to measure the inclination of the system. The control unit can calculate the angle between these to measure the inclination of the system. If this angle changes rapidly over time, the control unit may determine that the system is moving, for example, when the patient is moving between rooms. The control unit may signal an alert when certain conditions are detected by the camera / control unit. For example, a high-inclination alert, a movement alert, a detection alert (when blood, bubbles, or other conditions are detected in the urine), 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 be functionally empty, or may determine that there is a high likelihood of urine flowing back into the drainage tube. The control unit may automatically shut down certain functional aspects of the system, such as a discharge line cancellation function, a function to empty the reservoir, etc. The control unit may automatically put the system into a "dam forry mode" where the urine drainage flow path bypasses the cassette and discharges directly into the bag. In addition to or instead of this, the control unit may shut down a specific valve, such as a valve between the reservoir and the drainage tube.

[0071] A plurality of bed hooks 1116 are for hanging the control unit on a bed, other devices, etc. as required. These can also be used to hang the control unit on a portable device for patient transportation. The plurality of collection bag hooks / holes 1102 are 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 such that the weight of the fluid in the bag can be determined, thereby providing another method for measuring the volume of the fluid in the bag. For example, a piezoelectric transducer may 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.

[0072] The screen 1110 is for displaying information including the current urine / fluid volume status, the status of the system, etc. The screen 1110 may also be a touch screen and receive inputs including settings, changes to the screen display, changes to the menu, etc. The pressure port 1026, when in use, connects to the bladder pressure line 1010 that measures bladder pressure using a sensing Foley catheter. Alternatively, the pressure port may be placed within the cassette mount under the cassette 1022 or elsewhere within the control unit / base. The temperature within the port 1024 connects to a thermistor / temperature sensor that measures body temperature via a sensing Foley catheter through the lumen 1008 or by other means. The temperature output port 1122 is for transmitting any temperature measurement values to at least one of an external device and a monitor. The adapter port 1124 is for adapting the control unit to other devices, such as in the case of an RFID adapter. This can be used to activate any additional / advanced functions such as the measurement of IAP, respiratory rate, heart rate, cardiac output, or any other parameter measurable by the sensing Foley catheter. Thereby, additional parameters can be enabled and made payable by the hospital only if that information is desired. Also, the activation of advanced functions may be controlled, for example, by the use of different disposable components. Alternatively, the advanced functions may be enabled as part of a disposable or by an upgrade of software purchased separately. The software upgrade can be distributed wirelessly, via a USB dongle, a micro SD (registered trademark) card, an EPROM card, or other suitable technologies. Also, the data of each patient and / or aggregated patient data may be stored by the control unit. The patient data may be stored in a memory, a USB, a micro SD (registered trademark) card, an EPROM card, a hard disk, etc. The patient data may be transferred wirelessly or may be connected and transferred wired to another storage device such as a server on the Internet or a server on the intranet. The patient data can be anonymized.Patient data such as patient ID may be stored in the RFID adapter so that data unique to a specific patient is recognized by the control unit and associated with a disposable member used by that patient. The RFID adapter may be disposed on a disposable member of the system, such as on cassette 1022, or at other locations where the disposable member interfaces with non-disposable members. Additionally, all collected patient data may be stored in the RFID adapter, whereby different monitors can be used for the same patient without switching the disposable part of the system.

[0073] The power LED / indicator 1114 indicates on / off of the power. The error LED / indicator 1112 is an indicator when any error occurs within the system. Details of the error may be displayed on screen 1110, but the indicator 1112 warns the user that an error exists. The indicator may incorporate sounds and other alerts.

[0074] Port 1108 is for downloading, uploading, software upgrading, connecting to other devices, etc., such as integration with an electronic medical record (EMR) system. 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 source such as a wall to supply power to the control unit.

[0075] The urine / fluid drainage bag 1020 includes a one-way valve 1136 connected to an overflow tube 1138 and an outflow tube 1140 to prevent the once-collected urine / fluid from exiting the drainage bag. These valves also prevent air from entering the urine collection container 1022 such that when the pump 1134 is pulling a vacuum, the vacuum acts on the drainage tube but not on the bag. In a preferred embodiment, a single 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 a mount hook / hole 1102. The vent 1142 may be a hydrophobic vent or other vent that allows air or gas to exit the drainage bag but does not allow fluid to exit the drainage bag. This prevents excessive air and potential pressure from accumulating within the bag, thereby allowing for efficient filling of the drainage bag. The graduated markings 1144 indicate a somewhat crude measurement of the amount of fluid within the bag as the fluid is collected. 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 can also be configured as a strain measurement element to force an alarm to sound when the bag needs to be emptied when it reaches full capacity. Also, an alarm may sound if an undue excessive force is applied to the bag, such as when the bag is pulled or caught on an obstacle, for example, when moving a patient. Also, weight, or mass, can be used, for example, using a weighing scale, to determine if the bag is full. Alternatively, or in addition, a pressure measurement within the reservoir / cassette may be used to determine when the bag is full.

[0076] The overflow barrier 1137 is shown within the urine collection container / reservoir / cassette 1022. The overflow barrier is generally at a height higher than the 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 higher than the position of the 50 ml volume. For example, the overflow barrier may be about 5 to 10 mm above the position of the empty volume. Alternatively, the overflow barrier may be about 10 to 20 mm above the position of the empty volume. Alternatively, the overflow barrier may be about 20 to 30 mm above the position of the empty volume. Alternatively, the overflow barrier may be about 30 to 40 mm above the position of the empty volume. Alternatively, the overflow barrier may be about 40 to 50 mm above the position of the empty volume. Alternatively, the overflow barrier may be about 50 to 100 mm above the position of the empty volume. The path between the urine collection region 1135 and the overflow region 1139 may be direct as shown here, may be more serpentine as shown in FIGS. 101B to 101E, or may be complex.

[0077] The patient's body temperature is measured using a thermistor / temperature sensor provided within the patient's body. This temperature may be passed through the control unit for display on a third-party device. FIG. 10B shows that a parallel potentiometer may be used to reduce the error in temperature measurement before the temperature measurement value is transferred to an external display or external device.

[0078] 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 (registered trademark), or other suitable materials. The outflow valve can be formed from PVC, PC, or other suitable materials.

[0079] The pressure measurement value from the detection Foley catheter may be used to operate the pump, and as a result, the drainage tube becomes empty. For example, when the pressure detected in the bladder exceeds a preset number, the pump may engage to move urine more quickly through the drainage tube.

[0080] The control unit / base and / or reservoir / cassette may include an accelerometer or other sensor to determine when the control unit / cassette is horizontal and when it is not. An alarm may sound when the control unit / cassette is not horizontal. Alternatively, the urine measurement value may be adjusted to account for different angles within the system.

[0081] The bottom of the urine reservoir in the cassette may have a rounded edge or may be configured such that urine completely empties from the cassette when the pinch valve is opened.

[0082] In some embodiments, the control unit / monitor may be incorporated into the bed itself.

[0083] FIG. 10C is a detailed view showing an airlock elimination mechanism and a fluid collection and analysis system 1002. The screen 1110 displays a user interface including patient parameters, similar to a touch screen or other control functions. The heart rate region 1152 indicates the patient's heart rate determined by the control unit based on the measured value of the intravesical pressure detected by the sensing Foley catheter. The respiratory rate region 1154 indicates the patient's respiratory rate determined by the control unit based on the measured value of the intravesical pressure detected by the sensing Foley catheter. The core body temperature region 1156 indicates the patient's core body temperature detected by the temperature sensor in the sensing Foley catheter or detected by other means. The urine volume region 1158 indicates at least one of the patient's current urine volume and average urine volume determined by the control unit based on the urine volume measurement value measured by a pressure measuring device connected to at least one of the pressure interface 1150 and the ultrasonic transducer interface 1130. The sepsis index region 1160 indicates the likelihood of sepsis in the patient determined by the control unit based on one or more collected and / or calculated patient parameters. For example, factors such as body temperature, abnormal heart rate, abnormal respiratory rate, and / or urine volume may be considered in the determination of the sepsis risk. The trends of these parameters may also be used when evaluating the risk. For example, a decrease in urine volume, an increase in heart rate, an increase or decrease in body temperature may be indicators of sepsis.

[0084] Other risk assessments may 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, intra-abdominal hypertension, abdominal compartment syndrome, infection risk, sepsis, acute respiratory distress syndrome (ARDS), etc. FIG. 58A shows, for example, a sample of the risk algorithms for acute kidney injury and urinary tract infection. FIG. 58B shows a sample of the risk algorithms 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, presence or absence of bacteria, presence or absence of white blood cells, partial pressure of oxygen, etc.

[0085] The graphical indicator 1162 shows the historical data of any of these regions. For example, the user can switch the graphical display by touching the screen and display the patient's history such as urine volume, body temperature, heart rate, respiratory rate, sepsis index, risk of acute kidney injury, urinary tract infection, intra-abdominal hypertension, abdominal compartment syndrome, infection risk, or any other appropriate parameter. The time frame of the history may be all time, daily, hourly, or any period set by the user. Since it is out of range, risk factors with high risks may be automatically displayed here or at other locations on the display. At least one of the alert and the range may be set by the user and may include absolute values or trends over time. For example, if there is an increase in core body temperature more than twice over a specific time frame, it can be visually displayed or an audible alarm can be sounded.

[0086] Figure 11A shows a sensing 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 on 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 fluidly connects to the urine lumen 1012 at the valve 1182. In this embodiment, the design of the valve is simplified, and the drainage tube simply has an additional lumen compared to the embodiment shown in Figure 10A. The vent may be located anywhere within the system, and the fluid interface with the urine lumen may likewise be located anywhere within the system.

[0087] FIG. 11B shows a detection Foley catheter system according to an embodiment similar to that shown in FIG. 11A. In this embodiment, a gas-permeable vent / filter is incorporated into at least one of cassette 1022 and control unit 1018. The vent lumen may pass from barb 1182 through vent tube 1184 along drainage tube 1012. The vent lumen may terminate outside at least one of the cassette and the control unit, or as shown here, may pass through the cassette and optionally the control unit to incorporate gas-permeable vent / filter 1180. FIG. 11B further shows valve 1186. The valve may be a one-way valve that allows fluid (e.g., atmospheric pressure) flow to enter the drainage tube through the vent lumen, through the barb, or at other locations along the drainage tube or Foley catheter, or through the base / control unit 1018. The valve prevents fluid, such as at least one of urine and air, from flowing through the vent tube and reaching the filter. The valve may be passive as shown here, or may be actively controlled by the control unit. The valve may be provided anywhere within the vent lumen including within the barb, or anywhere along the vent tube, anywhere within the cassette, anywhere within the control unit, or anywhere outside the control unit, e.g., anywhere on the non-patient side of the control unit.

[0088] In some embodiments, the valve is actively controlled via a control unit by controlling the negative pressure within the drainage tube. The valve may open when the control unit pulls a negative pressure into the drainage lumen of the drainage tube, and the valve may close when the control unit reduces the vacuum applied to the drainage tube (i.e., applies less negative pressure, or zero pressure, or a slight positive pressure to the drainage lumen). Since the drainage lumen of the catheter and the drainage tube is in fluid communication with the lumen of the vent tube, the negative pressure applied to the drainage tube also acts on the lumen of the vent tube, and when the differential pressure across the valve exceeds the cracking pressure of the valve, the valve opens. The valve may be closed again by reducing the vacuum applied to the drainage lumen and reducing the differential pressure across the valve to a pressure below the cracking pressure of the valve. Thus, the control unit can actively control the opening and closing of the valve in the vent tube even when the valve itself is a passive valve.

[0089] In some embodiments, the control unit actively opening the valve may be performed, for example, periodically, such as on a regular schedule. This is shown graphically in FIG. 11F. For example, the control unit may open the valve at least every 30 minutes (represented by T1), may keep the valve open for at least 15 seconds (represented by T2), and then may keep the valve closed for an additional 30 minutes until the cycle starts again. The difference between the degree of vacuum applied when the valve is open and the degree of vacuum applied to maintain the closed valve state 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.

[0090] Figure 11F shows the valve closing pressure under negative pressure, but the valve closing pressure may be zero or may be positive pressure.

[0091] Alternatively, the length of the cycle may be variable, where at least one of T1 and T2 is determined according to the urine output flow rate. Alternatively, this cycle may be based on the system detecting an air lock in the drainage tube. This can be done by measuring the pressure within the system, for example, the vacuum pressure within the drainage tube or the pressure at the valve.

[0092] In some embodiments, valve 1186 may be arranged without a filter. In some embodiments, the filter may be between the drainage lumen and valve 1186.

[0093] In some embodiments, vent tube 1184 is provided integrally with drainage tube 1012 along all or part of the length of the drainage tube.

[0094] The valve may be a duckbill valve, umbrella valve, ball valve, dome valve, bell valve, cross slit valve, X-fragm valve, or any other valve suitable for medical use. The valve may have a very low crack pressure or a higher crack pressure, but generally it is between zero and the magnitude of the negative pressure pulled by the vacuum pump.

[0095] 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 having a smaller diameter between the barb and the valve. The tube with a smaller inner diameter between the barb and the valve forms a column of air between the valve and the barb, which generally prevents urine from entering the vent tube when the vent tube valve is closed. When the vent tube valve is open, the fluid flow generally flows in the opposite direction (i.e., into the drainage tube lumen), which can further prevent urine from entering the vent tube.

[0096] FIG. 11D is a diagram showing an example of a vent tube having different diameter portions. The first section 1188 is the section closest to the patient, has an inner diameter ID of ID1, and a length of L1. In this embodiment, due to the valve 1186, as indicated by the dashed arrow, the fluid can generally flow only from right to left. 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 from each other or the same. L1 + L2 may be approximately the same length as the drainage tube.

[0097] In some embodiments, ID1 may be about 1.8 to 2.0 mm. In some embodiments, ID1 may be about 1.6 to 1.8 mm. In some embodiments, ID1 may be about 1.4 to 1.6 mm. In some embodiments, ID1 may be about 1.2 to 1.4 mm. In some embodiments, ID1 may be about 1.0 to 1.2 mm. In some embodiments, ID1 may be about 0.8 to 1.0 mm. In some embodiments, ID1 may be about 0.5 to 0.8 mm. In some embodiments, ID1 may be 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 the siphon for all or part of its length.

[0098] In some embodiments, ID2 may be about 1.8 to 2.0 mm. In some embodiments, ID2 may be about 1.6 to 1.8 mm. In some embodiments, ID2 may be about 1.4 to 1.6 mm. In some embodiments, ID2 may be about 1.2 to 1.4 mm. In some embodiments, ID2 may be about 1.0 to 1.2 mm. In some embodiments, ID2 may be about 0.8 to 1.0 mm. In some embodiments, ID2 may be about 0.5 to 0.8 mm. In some embodiments, ID2 may be 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.

[0099] In some embodiments, L1 may be less than about 5 cm. In some embodiments, L1 may be less than about 10 cm. In some embodiments, L1 may be about 5 to 10 cm. In some embodiments, L1 may be about 10 to 20 cm. In some embodiments, L1 may be about 20 to 30 cm. In some embodiments, L1 may be 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.

[0100] In some embodiments, L2 may be about 50 to 150 cm.

[0101] In some embodiments, ID1 and ID2 may be the same.

[0102] FIG. 11E shows a catheter system according to an embodiment in which the vent lumen 1184 is in direct fluid communication with the fluid collection bag 1020. In this embodiment, a control unit including a detection function may or may not be present. In this embodiment, an air lock is avoided by a vent lumen that uses a vent 1142 in the fluid collection bag to vent the urine drainage lumen 1012. Additionally or alternatively, the vent may be located anywhere along the vent lumen. 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. In the fluid collection bag 1020 of this embodiment, and potentially in other embodiments, a rigid or semi-rigid portion 1196 may be included 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 connected at connection point 1194 of the drainage bag at or near the barb of the Foley catheter.

[0103] FIG. 12A shows a sensing Foley catheter system according to one embodiment similar to the system shown in FIG. 10A, but in contrast to the system shown in FIG. 10A, it does not utilize a pressure balloon. Instead, the pressure within the bladder is measured through the urine lumen (or other lumen) within the sensing Foley catheter. In this embodiment, the pressure lumen 1202 is connected to the vent 1204 or to other parts of the system outside 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 in combination with any standard Foley catheter. Note that any embodiment of the sensing Foley catheter system can be used in combination with a standard Foley catheter. The system shown in FIG. 12A may use a standard Foley catheter without using the pressure lumen 1202 if pressure measurement within the bladder is not desired.

[0104] In some embodiments of the detection Foley system, intra-abdominal pressure can be measured using a standard or off-the-shelf Foley catheter. In this way, the control unit can still incorporate the IAP measurement value into the analysis even when using a standard Foley catheter. In some embodiments, the control unit may operate a pump to introduce air or gas bubbles into the drainage line of the Foley catheter. By measuring the pressure in the drainage line via a pressure sensor, the control unit can determine the point at which the gas / air bubbles exit the Foley catheter and enter the bladder. The pressure required to push a column of fluid containing bubbles into the drainage line increases until the bubbles exit the drainage line. The pressure at which 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 may be done before or after performing air lock elimination. Also, the IAP measurement may be performed manually by physically observing the pressure of a gauge similar to a blood pressure cuff. Before performing this type of IAP measurement, the vent tube may be closed. The gas may be sterile and / or may be sterilized via ultraviolet light during transportation, for example in the barb area.

[0105] In some embodiments of the detection Foley system, an irrigation lumen may be included in the Foley catheter or an individual irrigation catheter having an irrigation lumen may be used to irrigate the bladder. In these embodiments, the control unit of the detection Foley system may communicate with an irrigation pump such that the control unit may subtract the amount of irrigation fluid from the measured fluid volume in order to accurately measure the urine volume (which does not include the irrigation fluid).

[0106] In an embodiment where a standard Foley catheter is used in combination with a sensing Foley system, a dedicated clamp can be used to clamp one or more lumens of the drainage tube without clamping the urine drainage lumen of the drainage tube. The clamp may be configured to align the clamping mechanism with the drainage tube. For example, it may be configured to close the pressure lumen while not closing the drainage lumen of the drainage tube.

[0107] 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 in this embodiment, there is still an anti-airlock function.

[0108] FIG. 13 is a diagram showing a sensing Foley catheter system according to an embodiment similar to that shown in FIG. 12A. In this embodiment, valve 1302 may be utilized to periodically close pressure lumen 1202 to the urine drainage lumen. The valve can be opened by the control unit or manually when pressure measurement is being performed, and can be closed again by the control unit or manually when bladder pressure measurement is not required.

[0109] FIGS. 10A, 10C, 11, and 12 are diagrams showing embodiments of a sensing Foley catheter system that includes a vent near the patient end of the drainage tube that allows air to enter the drainage tube when negative pressure is generated due to a siphon, or a pumping mechanism, or both, within the drainage tube. Without a vent / filter, such negative pressure can lead to suction trauma, such as trauma to the mucosal lining of the bladder. Note that these embodiments are different from devices that allow one or more vents to discharge air but not enter the drainage tube.

[0110] The urine drainage lumen preferably has an inner diameter of less than about 0.25 inches (about 6.35 millimeters) such that the liquid within the lumen maintains circumferential contact with the lumen, thereby forming a seal and allowing the liquid to advance when the pump mechanism is actuated. To prevent flow blockage in the event of pump mechanism failure, a plurality of drainage lumens may be provided. In these embodiments, the drainage lumens are preferably generally empty, which may be necessary for continuous operation of the pump mechanism. Alternatively, the pump mechanism may be actuated prior to volume measurement so that all liquid is reliably drained, thereby reducing the power requirements of the device.

[0111] Some embodiments of the sensing Foley catheter system include detecting a pressure spike in the drainage line while the pressure within the body organ is constant; and generating a negative pressure through the drainage line using a pump until the pressure in the drainage line equals the pressure within the body organ.

[0112] In one embodiment, the vent has a resistance to air flow that is greater than the resistance to liquid flow from the patient such that any accumulation of liquid within the patient's body is purged into the drainage line before air enters through the vent. For example, in the case of urine drainage, as long as the resistance to air flow through the vent is greater than the resistance of urine flowing through the patient's catheter, the bladder empties into the drainage line from a full state before air enters through the vent. However, the vent preferably has the minimum possible resistance to air flow while meeting this requirement to minimize aspiration trauma.

[0113] In another embodiment, the vent has very little resistance to the flow of air so that the bladder is further protected from suction, 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, to keep the drainage line urine-free. When the pump operates, it continues to operate until it detects that urine is no longer being discharged, which indicates that the bladder is completely empty. Alternatively, the pump may operate for a set time, such as about 30 seconds, about 1 minute, about 3 minutes, about 5 minutes, or about 10 minutes. The control unit pump may be inactive during the airlock relief interval or may generate a "background vacuum" (a pressure lower than the airlock relief pressure) during the airlock relief interval.

[0114] 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 centrifugal pump, or other suitable pumps. The pump can be powered from a wall outlet, a battery, manual power, or other suitable source. In some embodiments, the vacuum is in the range of about 0 to about -50 mmHg. Alternatively, the negative pressure may be supplied by a wall vacuum often present in the hospital room. The pump mechanism may include a pump such as peristalsis or suction applied directly to the urine collection container. The pump may be placed on the patient side of the drainage reservoir, and preferably, the pump may be placed on the non-patient side of the drainage reservoir / cassette such that the drainage reservoir is between the patient and the pump. For proper functioning, it is desirable that the pump can preferably generate a negative pressure equal to the maximum liquid column height in the drainage tube. This may be half the length of the drainage tube. For a urine drainage tube with a maximum length of 60 inches (about 1.52 meters), the maximum negative pressure required is about 30 inches H2O (about 0.762 meters H2O), i.e., 56 mmHg.

[0115] Other techniques may be used to push urine through at least one of a tube and a system that includes a pulsating mechanical stimulus, a vibrating acoustic stimulus, a thermal stimulus, a vibrating stimulus, a pinching stimulus, a rolling stimulus, or an electromagnetic stimulus to cause at least one of a drainage line and the movement of body fluid therein. In some embodiments, the rolling stimulus includes sequentially compressing a plurality of lumens such that the lumens are not all compressed simultaneously.

[0116] In another embodiment, the airlock is removed by a collapsible drainage tube that is present within a more rigid kink-resistant tube. FIG. 14A shows an uncollapsed form of such an embodiment. The inner collapsible drainage tube 1402 is inside the outer kink-resistant tube 1404. FIG. 14B shows an embodiment in which the inner collapsible tube is collapsed. Periodically, the drainage tube is collapsed, such as by applying a positive pressure to the space between the collapsible tube and the kink-resistant tube or by applying a negative pressure inside the collapsible tube. Collapsing the drainage tube subsequently causes urine to move away from the patient and toward the urine collection container.

[0117] In another embodiment, the drainage lumen elimination ring mechanism includes a tube having an inner diameter of less than about 0.25 inches (about 6.35 millimeters) so that the air pocket cannot move the length of the tube. This is due to the surface tension in the smaller tube preventing fluid movement when one end of the tube (as in the case of the bladder) is closed to the atmosphere. Thus, the drainage tube always remains full, and since urine is incompressible, the same amount of urine must exit the drainage tube for each amount of urine produced. In another embodiment, the inner diameter is less than 0.125 inches (3.175 millimeters). In another aspect, the drainage tube functions as a siphon, applying a small and safe amount of vacuum to the bladder. Alternatively, in a small lumen drainage tube, air can be allowed to enter the lumen of the tube periodically through a vent / valve. A negative pressure from a pump may facilitate this. The urine can be facilitated to flow into the collection reservoir by the negative pressure from the pump, thereby preventing an air lock.

[0118] Also, by using a smaller diameter tube, the residual urine volume in the drainage tube is reduced compared to the prior art. Since urine can move more quickly from the patient's bladder to the urine collection container, it is preferable that the residual volume is smaller. This transport rate is important for measuring recently produced urine. This is especially important for patients with a low urine production rate, as it takes even more time for the urine to be transported from the bladder to the urine collection container. For example, in the case of a patient secreting only 10 mL / hour using a standard drainage tube (with a residual volume of about 40 mL), the measured urine in the collection container is 4 hours behind the true urine secretion rate. In contrast, with a smaller tube (such as a tube with a residual volume of about 5 mL), the measurement is only 30 minutes behind the true secretion. In some embodiments utilizing a small diameter lumen, a pump for supplying negative pressure to the drainage line is not required, regardless of the presence or absence of a vent / valve.

[0119] FIG. 15 shows a device according to an embodiment suitable for the drainage of a chest tube or other drainage tube that applies a certain negative pressure to a patient. These embodiments are suitable for draining urine from the bladder as well as body fluids from other cavities. Any of the elements disclosed in connection with chest tube drainage can also be applied to bladder drainage or other body cavity drainage. Liquid is drained from the patient's body through a drainage lumen 1585 that connects to a urine collection container 1582. Drainage is assisted by pulling a negative pressure on the urine collection container 1582, for example, by attaching a suction tube 1583 to the hospital wall suction. Suction can also be applied by other methods, such as a pump as disclosed elsewhere in this specification. Air enters the drainage lumen 1585 through a valve 1584 having a crack pressure equal to the desired negative pressure. By selecting the correct crack pressure (e.g., -15 mmHg to 0 mmHg, or -10 mmHg), the pressure applied to the patient remains at this pressure as long as the hospital wall suction / pump can generate sufficient suction in the urine collection container 1582. Preferably, one or more drainage lumens used to drain the chest tube are as large as possible while maintaining a siphon. Suitable inner diameters include, but are not limited to, about 1 / 4 inch (about 6.35 millimeters), about 5 / 16 inch (about 7.9375 millimeters), or about 3 / 8 inch (about 9.525 millimeters).

[0120] FIG. 16 shows an apparatus according to another embodiment suitable for draining a chest tube or other drainage tube that applies a certain negative pressure to a patient. Liquid is drained from the patient through the drainage lumen 1688, and a negative pressure is applied using the pumping mechanism 1686. The pressure sensor 1687 is provided within the drainage tube at the patient end, thereby measuring the pressure applied to the patient. The measurement obtained by the sensor 1687 is sent back to a control unit that controls the pumping mechanism 1686, and the pressure generated by the pumping mechanism 1686 is adjusted to keep the pressure of the sensor 1687 (and the patient) at a desired level. Also, the pressure sensor 1687 may be disposed at other locations in the system. Further, this sensor may be used to passively monitor the pressure at the patient end of the tube in order to provide information regarding the level of suction being applied to the physician. In FIG. 16, the pump is on the patient side of the drainage reservoir, but alternatively, the pump may be on the opposite side of the drainage reservoir such that the drainage reservoir is between the patient and the pump.

[0121] In another embodiment of the present invention used for draining a chest tube, the volume of the drained fluid is measured in order to provide information regarding the drainage state of the chest tube to a physician. This measurement can be achieved by any suitable means, particularly those described herein for measuring urine volume.

[0122] In addition to eliminating air locks, some of the above-described detailed air lock elimination configurations have been found to effectively eliminate deposits and thrombi from the urine drainage line. These problems plague current urine drainage tubes, particularly those with smaller lumens, and the monitoring techniques in urine drainage bags. The present invention provides an advancement in the art by automating the elimination of these debris and thrombi that inhibit urination. This function is particularly useful when used in combination with pressure sensing either at the balloon at the tip of the Foley or in fluid communication with the bladder. This allows the pressure and vacuum within the bladder to be monitored, enabling more aggressive pumping based on the actual bladder pressure until the thrombus / obstruction is resolved. Without this pressure / vacuum sensing, pumping of the fluid within the drain tube can cause clinical sequelae of the bladder, such as suction trauma, by exposing the bladder mucosa to excessive vacuum.

[0123] In another embodiment shown in FIG. 17, the gas sampling lumen 1790 extends along the length of the drainage tube and terminates with a liquid-impermeable filter 1791 that is gas permeable but remains in contact with urine. The meniscus 1792 of the lumen 1790 is further from the patient than the filter. When measurement of oxygen, carbon dioxide, or any other gas is required, the air within the gas sampling lumen 1790 is drawn into the base 1789 of the drainage device for analysis. Such a configuration allows for accurate gas analysis even in embodiments of the device that introduce air into the drainage line as shown in FIGS. 10-16.

[0124] As shown in FIG. 18, the active venting system is composed of a vent 1802, a drainage line 1804, a urine collection container 1806, and a pump 1808. The vent side of the drainage line is connected to the patient. In one embodiment, the fluid to be discharged is urine and is connected to a urinary catheter. The fluid flows from the patient through the drainage line and is collected in the urine collection container. The pump in this embodiment does not act directly on the drainage line but draws a vacuum on the urine collection container. The pump promotes drainage by drawing a negative pressure on the urine collection container and flushes the fluid through the drainage line. Preferably, the urine 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 blocks the permeation of liquid. By doing so, the vent prevents a substantial negative pressure from being applied to the patient by allowing atmospheric pressure to enter the system. Such a mechanism prevents, for example, suction trauma to the bladder wall.

[0125] The pump in this embodiment may include, but is not limited to, a peristaltic pump, a diaphragm pump, or a centrifugal pump, and any pump suitable for pumping gas may be used. To function properly, the pump should preferably be able to generate a negative pressure equal to the maximum liquid column height in the drainage tube. This may be half the length of the drainage tube. For a urine drainage tube with a maximum length of 60 inches (about 1.52 meters), the required maximum negative pressure is about 30 inches H2O (about 0.762 meters H2O), i.e., 56 mmHg.

[0126] As shown in FIG. 19, an active venting system for discharging body fluids may include additional vents. One such vent, vent 1962, may be disposed in the urine collection container, allowing air to escape from the urine collection container. This ensures that each volume of fluid entering the system is offset by the same volume of air exiting the system, preventing pressure buildup when new fluid enters the container. Another such vent, vent 1964, may be disposed between the urine collection container and the pump. This vent allows gas (preferably air) to permeate while preventing the permeation of liquid, thereby preventing bacteria and viruses from entering or leaving the urine collection container or drainage tube. Preferably, this vent is of a sterile grade, meaning that the passing air is considered sterile. A vent (not shown) may or may not be present at the patient-side end of the drainage line.

[0127] As shown in FIG. 20, pressure offset may be achieved with a single vent on the urine collection container. In this case, the vent, i.e., vent 2072, may be located between the urine collection container and the pump as before, but an additional valve 2074 allows air to escape from the urine collection container in the presence of positive pressure. This valve is preferably a one-way valve that allows air to exit the system but not enter it. When the pump operates, the one-way valve closes, and air must be drawn out of the urine collection container, creating a negative pressure within the urine collection container and facilitating the flow of fluid through the drainage line. A vent may or may not be present at the patient-side end of the drainage line (not shown).

[0128] Detection of Infectious Diseases

[0129] FIG. 21 is a diagram showing a urine collection container, chamber or cassette according to one embodiment that may be included in a urine collection catheter system for detecting bacteria, blood and / or other substances in urine using UV / light / Raman spectroscopy. Cassette 2100 preferably includes a container wall 2102 having rigidity. Urine 2106 is collected in the cassette. If the urine is collected too early, or if there is any obstacle to emptying the cassette, or if there is an obstacle to emptying it quickly enough (e.g., in a situation where the urine flow rate is high), the overflow region 2104 allows excess urine to be discharged from the cassette. Cassette 2100 may preferably include an optically transparent portion 2110 incorporated in the outer wall of the cassette and a reflective portion 2112 preferably on the inner wall of the cassette or incorporated in the inner wall of the cassette. As used herein, "optically transparent" means that light of one or more required analysis wavelengths can be transmitted through the optically transparent portion. Preferably, the optically transparent portion is formed of a material that can transmit ultraviolet light, such as polymethylmethacrylate, polystyrene, acrylic, quartz, etc. The wall thickness may need to be thin enough so that one or more appropriate UV wavelengths can be transmitted through the optically transparent portion. For example, the thickness of the optically transparent portion may be about 0.5 mm to about 0.7 mm. Alternatively, the thickness of the optically transparent portion may be between about 0.5 mm and about 0.6 mm. Alternatively, the thickness of the optically transparent portion may be between about 0.6 mm and about 0.7 mm. Alternatively, the thickness of the optically transparent portion may be less than about 0.7 mm.

[0130] The ultraviolet / light transceiver 2108 transmits ultraviolet light or light of other wavelengths of appropriate wavelengths through the optically transparent part 2110 to the reflector 2112 in the cassette through the urine in the cassette. The ultraviolet / light transceiver may be incorporated into or connected to the control unit components of the detection Foley catheter system. The light is reflected to the UV / light receiver, and the receiver transmits the collected data to the control unit for signal analysis. Two or more wavelengths of ultraviolet / light may be analyzed simultaneously or continuously. Light outside the ultraviolet range may be used in addition to light within the ultraviolet range. The volume of urine between the physical light transmission and 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. 21 or in other areas of the cassette. The receiver is in a different location from the transmitter, and the reflector may or may not be required and may or may not be present. Since the urine in the cassette frequently empties, ultraviolet / light absorption measurements can be collected over time, and the increase and / or decrease in the level of one or more substances in the urine can be tracked over time, substantially or almost in real time. It is particularly important to quickly identify infectious diseases such as urinary tract infections and catheter-related urinary tract infections (CAUTI). Also, UV / light detection may be performed at other locations in the detection Foley catheter system, including within the drainage tube, individual sampling areas, etc.

[0131] Infections can be identified by analyzing bacteria, red blood cells, plasma, and / or white blood cells in urine using ultraviolet / optical spectroscopy. FIG. 22A 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 can all be indicators of an infection. The presence of red blood cells may not indicate an infection. Therefore, it is desirable to distinguish red blood cells in urine from bacteria / plasma / white blood cells. Since the spectroscopic signature of red blood cells is quite different from that of bacteria and plasma / white blood cells at a wavelength of about 414 nm, by analyzing the absorption of light at this wavelength, the signal of red blood cells can be separated from the signals of bacteria and / or plasma / white blood cells, and an infection can be identified. At wavelengths of 260 nm and 280 nm, since the signatures of plasma and bacteria are different from each other, 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 may be used over a continuous wavelength range and also over time. The signals may be deconvolved or demixed to determine the amount of the analyte and / or to form the basis of features for developing an analysis algorithm.

[0133] In addition, various substances in urine or collected / discharged body fluids can also be detected using other wavelengths and other technologies. Turbidity can also be detected using ultraviolet / light absorption. Dyes, drugs, and reactive substances can be introduced into the system or coated inside the system or cassette to react with substances in urine to assist in analysis. Any type of sensor can be used to detect the substances or quality of the collected urine, either intermittently or continuously, in real time. For example, one or more sensors for detecting magnesium in urine can be used for the diagnosis of preeclampsia or eclampsia. Lactate sensors can be used for the examination of lactate (or lactate dehydrogenase) in urine. Identification of lactate in urine may be an early indicator of sepsis. The lactate sensor may include an enzyme lactate sensor. For example, lactate sensors such as those disclosed by 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, and both of these documents are hereby incorporated by reference in their entirety.

[0134] Visible wavelengths can also be used. For example, a camera that captures visible light can be used to monitor the collected urine over time. The images collected by the camera may be analyzed for the wavelength of color, turbidity, color intensity, color consistency or inconsistency, and / or intensity and / or turbidity, cloudiness, presence of blood or thrombus, hemolysis, bubbles, protein, etc. Since the urine images may be taken at substantially any time increment over several hours or days, the urine can be monitored for the presence or absence of factors indicating the patient's condition, or changes that may indicate a change in the patient's condition. For example, identifiable conditions may include dehydration (based on how yellow the urine is), bleeding (based on the presence of blood), protein in the urine (based on bubbles in the urine), infusion (based on cloudiness, bubbles, color, turbidity, etc.). When evaluating the characteristics of urine collected over time using a camera, it may be important to evaluate a small amount of recently collected urine so that the urine is not diluted by old collected urine. This can provide substantially real-time feedback regarding the patient's condition. To that end, the camera may be directed at the urine at the entry portion of the cassette 2100, such as at the lower part of the drainage tube or the upper part of the cassette 2100, where the drainage tube and the cassette 2100 are connected.

[0135] Reference colors may be included in the system, such as in the cassette, to calibrate the camera to baseline red, blue, and green colors. For example, reference regions of red, green, and blue (such as reference stickers having red, green, and blue regions) may be placed near the camera (either inside or outside the cassette), or on the opposite side of the cassette, and the camera may be made able to see both. The nearer reference calibrates the camera to the color without urine, and the farther 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 performed by the control unit. Possible image processing steps include classification, feature extraction, multi-scale signal analysis, pattern recognition, projection, edge or boundary detection, anisotropic diffusion, hidden Markov models, image editing, image restoration, independent component analysis, linear filtering, neural networks, partial differential equations, pixelation, principal component analysis, self-organizing maps, wavelets, filtering, noise removal, edge enhancement, contrast enhancement, morphology, dilation, erosion, Fourier transform, etc.

[0137] When the control unit detects something outside the preset range by the camera, for example, when the color of urine is outside the normal range, when the inclination of the system is outside the allowable range, when the inclination angle of the system changes more frequently than the preset frequency, when the turbidity of urine is outside the normal range, when something abnormal such as blood is detected in the urine, etc., the control unit may issue a warning to the user.

[0138] In an embodiment where a visible wavelength camera is used, a live or semi-live feed of urine within the system may be projected remotely. For example, the view of the urine reservoir / cassette may be projected onto a monitor on a table, computer, phone, in any room or other location. This feature can hide the urine in at least one of the reservoir and urine bag near the patient, which is considered to be more comfortable for the patient and their visitors. That is, the actual urine near the patient may be hidden or covered with an opaque material, and the image feed of the urine may be displayed in another location. The urine in any or all of the cassette, drainage tube, urine bag, etc. may be hidden with an opaque material.

[0139] FIG. 22B shows the display 1110 on the control unit / monitor 1018 according to one embodiment, and this display 1110 includes the current values and past trends of IAP, body temperature, urine volume, and urine color. The urine color may be detected via the camera disclosed in this specification. Note that in this figure, colors are displayed in black, white, and grayscale, but actual colors such as yellow, orange, and red may also be displayed. The setting 2202 may be available for displaying data in different history ranges such as 1 hour, 6 hours, 12 hours, 24 hours, etc.

[0140] Note that in the embodiments disclosed in this specification, a user interface display on the control unit / monitor is shown. However, the display, or components of the display, or an aggregated display may be additionally or alternatively displayed on a computer, mobile computer, mobile phone, tablet, individual monitor / screen, etc. For example, a part of the display may be displayed on a portable tablet, and the tablet may be used individually or docked to the control unit / monitor. The tablet, phone, or other device may be synchronized with the control unit in proximity using, for example, RFID. The display may display information regarding individual patients and / or information regarding multiple patients at a nurse station, etc. The display may display data of multiple patients individually or may aggregate and display data of multiple patients. Also, multiple different screens may be incorporated into the display and be accessible by toggling between the screens. In some screens / displays, administrator login authentication may be required, such as for adjusting the settings of the Foley system.

[0141] An RFID or other mechanism may be used additionally or alternatively to prevent the use of unauthorized "knock-off" disposable parts of the system. In this way, the control unit / monitor can recognize authorized and unauthorized disposable parts. The system may warn the user or may not function if there are unauthorized disposable parts. A similar ID mechanism may be used to control elements of the system. For example, a user may have paid a subscription fee to access the IAP function of the system. The same disposable unit may be used for those who have subscribed to the IAP function and those who have not, but the control unit may be programmed to reflect the subscription details, and the ID mechanism may permit the disposable IAP function for those who have subscribed to this function. Due to the ID mechanism, those who have not subscribed to this function may have the IAP function not function. Alternatively, instead of this, the control unit may be able to make the function function only once or a limited number of times for those who have not subscribed to the function.

[0142] Drugs or drug residues in the collected urine can be detected using a suitable sensor. Other substances or characteristics of the collected urine that can be detected include color, transparency, odor, specific gravity, osmotic pressure, pH, protein, glucose, creatinine, nitrite, white blood cell esterase (WBC esterase), ketones, red blood cells or white blood cells, casts, crystals, bacteria, yeast cells, parasites, squamous epithelial cells, etc.

[0143] CAUTI or infection can be identified and / or reduced by several methods including analyzing urine using spectroscopy, light wavelength analysis, etc. to identify contaminants early, reducing trauma to the bladder caused by suction, reducing urine retention in the bladder, reducing the presence of bacteria or microorganisms by using antibacterial coatings or implanted materials such as silver, improving the accuracy of pressure measurement in the bladder by reducing suction in the bladder, and improving the accuracy of urine volume measurement by reducing air locks in the system and suction in the bladder. A pressure spike caused by suction in the bladder may be defined as a pressure measurement value of less than about -20 mmHg. Alternatively, a pressure spike caused by suction in the bladder may be defined as a pressure measurement value of about -10 mmHg to less than about -20 mmHg. Alternatively, a pressure spike caused by suction in the bladder may be defined as a pressure measurement value of less than about -10 mmHg.

[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 in the system. The urine may be treated using ultraviolet light that sterilizes the urine in the cassette, or may be treated elsewhere in the system. For example, as shown in FIG. 101A, ultraviolet light may sterilize the urine as it enters the cassette, e.g., at the inlet point valve 10104, or within the cassette, or above the cassette, e.g., within the drainage tube above the cassette.

[0145] FIG. 23 is a diagram showing a cassette including a baffle or flap 2302 according to one embodiment. This baffle / flap is for preventing urine from seeping out along the inner wall of the cassette as shown by the dotted arrow. Since the baffle prevents urine from seeping out beyond the point of the baffle, the urine flows back into the lower measurement reservoir.

[0146] Priming

[0147] Among the disclosed techniques, the aspect that it is particularly advantageous to achieve a high-resolution signal capable of monitoring pressure profiles (such as intraperitoneal pressure, respiratory rate, and heart rate, relative pulmonary ventilation, cardiac output, relative cardiac output, and absolute cardiac stroke volume, etc.) from a specific physiological source is related to adjusting and maintaining the pressure equilibrium on either side of the pressure interface represented by the membrane of the pressure sensing balloon. This pressure equilibrium is sometimes referred to as differential pressure. In some embodiments, the preferred differential pressure is zero or near zero. 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) changes according to the patient's physiological state. The pressure applied to the inner circumferential surface of the balloon (which is in fluid communication with the fluid column) is subject to degradation due to fluid leakage or an imperfect seal.

[0148] Upon initial insertion of the sensing Foley catheter, external pressure is typically applied to the fluid column up to a first approximation of the pressure exerted from within the bladder onto the pressure interface. The pressure signal measured across the pressure interface has a maximum amplitude when the differential pressure is approximately zero. Thus, the amplitude of the pressure signal can be used to adjust the pressure applied from the fluid column to the pressure interface. This process of applying an appropriate amount of pressure to the interface may be referred to as priming the fluid column or priming the balloon. As described above, since the pressure on either side of the pressure interface may change, the fluid column may sometimes require re-priming or readjustment. The need for re-priming can be monitored by testing small changes in pressure to achieve the maximum amplitude of the pressure signal profile. Alternatively, priming can occur automatically via the control unit periodically.

[0149] Embodiments of the disclosed systems and methods include automatic pressure regulation by a control unit. Accordingly, the regulation system can monitor the detected pressure signal and detect the optimal target pressure and volume for inflating the balloon by adding or removing air or fluid volume as needed. For example, upon insertion of a catheter, the pressure regulation circuit that adjusts the volume and pressure of the balloon may inflate the balloon until it detects the pressure rate of physiological origin. Once that rate is detected, the pressure regulation control unit may add or subtract a small amount of air in a series of routine or programmed steps until the detected amplitude of the wave is maximized. The control feedback loop between the optimally adjusted pressure (manifested as the pressure and volume of the balloon) and the detected physiological pressure profile is performed continuously or repeatedly as needed to ensure faithful measurement of physiological data. In some embodiments, the automatic pressure regulation may be performed ostensibly in the background while physiological data is being transmitted and displayed, and 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 delivery system that can deliver gas during a priming operation, whereby pressure can be applied to a fluid column proximate to a side face facing the proximal side of a pressure interface. A gas source such as compressed air or liquid is held in a storage tank. Using CO2 as an example, the CO2 is controllably released from the storage tank via a pressure regulator that can step down the pressure in the tank (e.g., a pressure of about 850 psi (about 5.86 MPa)) to a range of about 1 psi (about 6.89 kPa) to about 2 psi (about 13.79 kPa). The released gas passes through a filter and a pressure relief valve set at about 2.5 psi (about 17.23 kPa). The pressure relief valve is a safety feature that prevents gas flow at levels above 2.5 psi (about 17.23 kPa) in the event of a failure of the upstream regulator. The CO2 exiting the pressure relief valve then passes through a first solenoid-controlled fill valve and into a catheter line, and ultimately fills a balloon that constitutes a pressure sensing interface. When the pressure in the balloon rises to 30 mmHg, the first solenoid control valve closes. A second solenoid control valve distal to the first valve operates as a drain valve, which can release the pressure from the catheter to the target pressure. Alternatively, the drain valve may be operated until a respiratory waveform is detected, after which the balloon is optimally primed and the valve is closed. The drain valve may be operatively proportionally controlled based on voltage or pulse width modulation (PWM), whereby the drain rate is slow enough to reach the target pressure and the valve can be closed before overshoot. Alternatively, a peristaltic pump or other air pump may be utilized to fill the balloon with room air.

[0151] Figure 24 is a graph representing a method of priming a pressure balloon in some embodiments. Here, a burst of a small volume of liquid (about 0.3 cc) is applied to a pressure sensing balloon, and the pressure inside the balloon is measured. Small volume bursts of fluid are introduced until the measured pressure inside the balloon settles to a stable pressure 2401. This transition is shown at the inflection point 2402. A volume burst is introduced past this point until the measured pressure begins to increase rapidly (e.g., when the slope of the curve 2404 is greater than about 2 mmHg / 10 milliseconds). This inflection point is shown at 2406. At this point, the pressure inside the balloon drops to a pressure around or slightly above the stable pressure 2401. This pressure represents the prime pressure measurement pressure in some embodiments. This process is also represented in the flowchart of FIG. 27.

[0152] Alternatively, priming of the pressure balloon may include pressurizing the pressure balloon well above zero mmHg, then removing a small amount of air / gas / fluid and monitoring the pressure of the pressure balloon. The pressure of the pressure balloon stabilizes or plateaus as it approaches the optimal primed pressure. To determine this optimal pressure, a pressure measurement is taken when a small amount of air is removed from the pressure balloon, and if subsequent pressure measurements are essentially the same (within about 2 mmHg of each other), the balloon is at the optimal priming pressure. If two subsequent measurements are not essentially equivalent, the pressure balloon is repressurized well above zero mmHg and the process is repeated. The pressure measurement taken when a small amount of air is removed from the pressure balloon may be taken over a period of about 5 seconds to about 15 seconds to compensate for the effect of respiration on the pressure measurement. In some embodiments, the pressure signal may require a short stabilization period after a small amount of air / gas / fluid has been removed from the pressure balloon before the pressure measurement is taken.

[0153] The burst of a small volume of fluid may be from about 0.2 cc to about 0.4 cc. The burst of a small volume of fluid may be from about 0.1 cc to about 0.5 cc. The burst of a small volume of fluid may be up to about 0.5 cc maximum. The burst of a small volume of fluid may be up to about 1.0 cc maximum.

[0154] Figure 25 shows a graph representing a method of priming a pressure balloon in some embodiments. This method is similar to the method shown in Figure 24, except that it raises the pressure inside the pressure sensing balloon more smoothly without the burst shown in Figure 24. Add a fluid volume to the pressure sensing balloon and measure the pressure inside the balloon. Raise the balloon pressure until the pressure measured inside the balloon settles to a stable pressure 2505. This transition is indicated by an inflection point 2506. The balloon pressure rises beyond this point until the measured pressure begins to rise sharply (e.g., when the slope 2510 of the curve is greater than about 2 mmHg / 10 milliseconds). This inflection point is shown at 2508. At this point, the pressure inside the balloon drops to around the stable pressure 2505 or slightly above. This pressure represents the optimal or prime pressure in some embodiments. This process is also represented in the flowchart of Figure 28.

[0155] Figure 26 is a flowchart of a balloon priming process of a particular embodiment of the present invention. Embodiments of the disclosed systems and methods include automatic pressure regulation by a control unit. Accordingly, the regulation system can monitor the detected pressure signal and detect the optimal target pressure and volume for inflating the balloon by adding or removing air as needed. For example, upon insertion of the catheter, a pressure regulation circuit that adjusts the volume and pressure of the balloon inflates the balloon until it detects the pressure rate of physiological origin. Once that rate is detected, the pressure regulation control unit adds or subtracts a small amount of air or fluid (about 0.3 cc) in a routinized sequence until the amplitude of the detected wave is maximized. The control feedback loop between the optimally adjusted pressure (manifested as the pressure and volume of the balloon) and the detected physiological pressure profile is performed continuously or repeatedly as needed to ensure faithful measurement of physiological data. In some embodiments, the automatic pressure regulation may be performed ostensibly in the background while physiological data is being transmitted and displayed, and in other embodiments, the system may pause the transmission of physiological data during the pressure regulation sequence.

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

[0157] In some embodiments, the priming of the balloon may be based on the characteristics of the system. The pressure balloon may be inflated one, two or more times to characterize a system including an ultrasonic transducer, a pressure pump, the resistance within the system, the pressure balloon, etc. The pressure balloon may be pressurized over a range of pressures to determine the characteristics of the particular system at that time. This information is subsequently used to optimize the inflation pressure of the pressure balloon.

[0158] Loop control unit

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

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

[0161] For example, IAP may be used to control the intravenous infusion rate. If the IAP becomes too high, the infusion rate can be reduced or stopped until the IAP returns to the acceptable range. IAP combined with at least one of the relative stroke volume and the variability of the stroke volume (the variability in the magnitude of the heart rate seen in the bladder etc. during the respiratory cycle) can be used to indicate IAP as an indicator of fluid overload, and an increase in relative stroke volume and a decrease in stroke volume variability as indicators indicating the need for additional body fluid, enabling excellent control of the infusion of intravenous drip solutions or blood products. Urine output may be further added to a control loop that provides an indicator indicating that the body fluid state has recovered due to the return of urine output. The heart rate may be used in combination with the respiratory rate to control the infusion of drugs (drug type, infusion rate, frequency, dosage, etc.). In this way, the drug may be used to lead the patient to a more stable state determined by the heart and respiratory rates. Also, IAP and respiratory rate may be used to control a mechanical ventilator or respirator. When the IAP rises, the positive end-expiratory pressure (PEEP) delivered by the mechanical ventilator should also rise to overcome this pressure. An indicator of inadequate ventilation is seen in at least one of the natural respiratory rates that are regarded as signals underlying tissue oxygenation and mechanical ventilation. This signal may be extracted during mechanical ventilation, or preferably, the loop controller may temporarily stop the mechanical ventilator so that the underlying respiratory rate / respiratory drive can be detected more precisely and accurately. This IAP, tissue oxygenation, and / or respiratory rate may be used to warn the provider of the worsening of the patient's symptoms and / or may be used to automatically adjust the settings of the ventilator including respiratory rate, PEEP, %O2 trigger, and other settings. In an ideal scenario, these parameters can be used by the loop controller to monitor and control the treatment in a way that obtains information through machine learning and algorithm adjustment. These are just a few examples, but there are many combinations. One or more parameters can be used to control one or more treatment devices.

[0162] Figure 29 is a diagram showing a loop control unit in a patient environment according to an embodiment. In this example, the loop control unit is receiving patient parameter input from a sensing Foley catheter 2902. The sensing Foley catheter is present within the patient's bladder 2904 and includes a retention balloon 2908 and a pressure sensing balloon 2910. The sensing Foley catheter may include other sensors as disclosed herein.

[0163] The sensing Foley catheter 2902 includes a retention balloon inflation lumen, a pressure balloon sensing lumen, and a urine lumen. The pressure sensing balloon 2910 is connected to a pressure sensing lumen that is connected to a pressure transducer 2920 that may be incorporated into the control unit 2928. The urine lumen is connected to a urine output tube 2912. The urine output tube empties into a urine reservoir 2914 that may be connected to a urine volume measuring device 2916 or may be incorporated into the control unit as disclosed herein. Additionally, the urine output may be controlled by a urine pump 2918, which may be disposed on the urine drainage tube, incorporated into the control unit, or disposed on the non-patient side of the control unit as disclosed elsewhere herein.

[0164] This patient is shown with a respiratory mask 2922, which is supplied by a respiratory tube 2924. The flow and composition of the respiratory gas are controlled by a respirator 2926.

[0165] The loop control unit 2928 is connected to the urine volume measuring device 2916, the urine pump 2918, the pressure transducer 2920, and the respirator 2926 via corresponding connectors 2930, 2932, 2934, 2936. The connectors can be either wired or wireless. Alternatively, in this and other embodiments, some or all of the urine volume measuring device 2916, the urine pump 2918, and / or the pressure transducer 2920 may be incorporated into the control unit 2928.

[0166] In this example, the loop control unit 2928 can receive patient parameter inputs from the urine volume measurement device 2916 and the pressure transducer 2920, and use the information provided by these parameters to control the urine pump 2918 and the respirator 2926. Some of the parameters that the loop control unit may receive from the sensing Foley catheter include, but are not limited to, those disclosed herein: IAP, respiratory rate, heart rate, stroke volume, tissue oxygenation, tissue perfusion pressure, body temperature, urine analyte, urine output volume, and other parameters.

[0167] For example, if the loop control unit receives parameter information indicating that the patient's IAP is increasing, the loop control unit may control the respirator perfusion rate, pressure, or other parameters. The loop control unit may incorporate data from one or more input parameters to control one or more therapeutic medical devices. For example, based on the received increasing IAP parameter and abnormal tissue oxygenation parameter, the loop control unit may control the output of the respirator 2926 and also control the urine output rate by controlling the urine pump 2918.

[0168] The loop control unit continuously monitors one or more parameters of the patient and adjusts one or more therapeutic medical devices accordingly. When the patient parameters normalize, the control of the therapeutic medical devices is adjusted accordingly so that the feedback loop controlled by the loop control unit becomes a closed loop. Also, the loop can be adjusted manually as needed, in which case the loop may be an open loop or a semi-closed loop.

[0169] FIG. 30 is a diagram showing another example of a loop control device in a patient environment. In this embodiment, the patient has an intravenous (IV) line 3002 in a blood vessel of the arm. The intravenous (IV) fluid bag 3004 is elevated to drip and / or infuse IV fluid to the patient via the IV line 3002. The valve 3006 controls the flow rate of the IV infusion to the patient by allowing the fluid flow freely, restricting the flow, or stopping the flow. Here, the valve 3006 is controlled by the loop control unit 2928 via the connection part 3008. The IV fluid bag 3004 may contain at least one of a fluid for rehydration and a drug. One or more IV infusion bags may be involved, and one or more valves may control one or more IV infusion bags. The loop control unit may control the flow and content of one or more IV fluids to the patient based on the patient parameters received by the loop control unit.

[0170] FIG. 31 is a diagram showing another example of a loop control unit in a patient environment. In this embodiment, a fluid drainage line 3102 is inserted into the patient's abdomen. The fluid from the abdomen may flow from the patient to the receptacle 3104. The fluid flow may be controlled by a pump 3106 controlled by the loop control unit 2928 via the connection part 3108. The loop control unit may control the fluid flow from the patient to the receptacle 3104 via the pump 3106 based on the received patient parameters. For example, when the IAP is abnormally high, the loop control unit may increase or initiate the fluid removal rate from the patient by controlling the pump 3106.

[0171] FIG. 32 is a diagram showing another example of the loop control unit in a patient environment. In this embodiment, the patient has an intravenous (IV) line 3202 in the blood vessel of the arm. The drug infusion device 3204 controls the flow rate of the drug to the patient via the intravenous IV line 3202. Two or more drug infusion devices may be used. Here, the drug infusion device 3204 is controlled by the loop control unit 2928 via the connection part 3206. The drug infusion device 3204 may include at least one of any appropriate fluid and drug. The loop control unit may control the flow and content of one or more drugs to the patient based on the patient parameters received by the loop control unit.

[0172] Note that in these examples, a part of the medical treatment device controllable by the loop control unit is shown, but any medical treatment device can be used.

[0173] FIG. 33 is a detailed diagram showing the loop control unit. The loop control unit 2928 can receive one or more patient parameter inputs from a sensing Foley catheter or other device. These inputs include, but are not limited to, urine output volume and rate, pressure profile from the bladder, and sensor information from a sensing Foley catheter or other device. The pressure profile information from the bladder can be further analyzed to determine IAP, respiratory rate, heart rate, stroke volume, sepsis index, acute kidney injury (AKI) index, and other patient parameters. This analysis may be performed within the loop control unit 2928 or within an individual control unit connected to the loop control unit by either a wired connection or a wireless connection. The connection may be via a network such as the Internet, intranet, WAN, LAN, etc., or may be local 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. The one or more medical treatment devices may be controlled to bring the patient parameters into 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 the standard state. The standard state is different for each medical treatment device and may also be different for each patient. Similarly, the target range of patient parameters is different for each patient and for each state of the patient. For example, the target range of the respiratory rate may be different depending on whether the patient is in a sedated state or not.

[0175] In embodiments of the present technology, the infusion rate of a fluid or drug within a vein may be automatically adjusted based on feedback from a detected cardiac output or respiratory rate. In such an embodiment, a patient-controlled analgesia pump may be deactivated if the respiratory rate is too low. Respiratory distress can be potentially fatal in this group, and this safeguard may prevent overdose. An automated feedback system may also be effective in large-volume resuscitation procedures, where fluid infusion is adjusted based on intra-abdominal pressure, and an alarm is sounded and the infusion rate is slowed in response to an increase in intra-abdominal pressure, thereby preventing intra-abdominal compartment syndrome. Yet another automated feedback function may provide feedback directly to a ventilator system to provide an optimal pressure for ventilation gas. At elevated abdominal pressure settings, typical ventilator settings may not be able to provide adequate respiration to the patient. Automated adjustment of ventilator settings based on intra-abdominal pressure feedback from this embodiment can effectively provide optimal patient ventilation. Also, embodiments of the present technology may be applied as corrections in the application or understanding of other diagnostic measurements. For example, central venous pressure may be dramatically distorted in situations where intra-abdominal pressure is elevated. Direct access to these data by a central venous pressure reporting system enables automatic correction and accurate reporting of this important physiological parameter. Embodiments of the present technology may also be used in a variety of other ways to automate treatments that include infusion of a fluid that may further contain an active agent such as a vasopressor or diuretic in response to an increase or decrease in cardiac output or other parameter.

[0176] Other inputs and outputs to the loop control unit may include nutrients provided via a feeding tube or intravenously, wound drainage, excretory output, wound drainage, chest drainage, sweating, exhaled vapor output, etc. Sweat may be measured and evaluated by measuring body temperature, ambient temperature, and ambient humidity, or in the case of a ventilated patient, the temperature and humidity of the inhaled air may be measured. Alternatively, or in addition, a skin sweat sensor may be used.

[0177] In addition to directly controlling one or more medical treatment devices, loop control unit 2928 may sound an alarm including an audible alarm, an alarm by email, an alarm by text, an alarm by pager, etc. Loop control unit 2928 may also provide an output to other systems for system integration, such as output of information to an electronic health record (EHR) or other data archive system, or other systems. Loop control unit 2928 may also receive inputs from various EHRs, EMRs, or other systems.

[0178] Medical treatment may be administered to a patient as a result of data collected and / or analyzed by a sensing Foley catheter system. This treatment may be a drug automatically administered via the loop control unit, or it may be a conventional drug administered manually via oral, injection, etc.

[0179] Based on the results of the sensing Foley catheter system, further medical diagnosis may be performed.

[0180] Specific gravity

[0181] Urine specific gravity may be measured by pressure measurement and ultrasonic measurement using a sensing Foley catheter. FIG. 34 is a plot showing how ultrasonic and pressure measurements of volume diverge with liquid density. The liquid being measured is a synthetic urine concentrate with a specific gravity of about 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 density increases, they begin to diverge. For pressure, since V = A*h and P = ρ*g*h, or V = A*ρ*g / P, the volume measurement increases with increasing density. For ultrasound, 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 reading decreases with increasing density. V: Volume A: Cross-sectional area h: Height of the liquid P: Pressure ρ: Liquid density g: Gravity V: Speed of sound t: Time for sound to reflect E: Bulk modulus of the liquid

[0183] Simply put, as the density of the liquid increases, the pressure rises and its measured value becomes higher obliquely. At the same time, sound moves more quickly and distorts the measured value of the ultrasonic wave lower. By measuring how much it diverges, the density of the liquid can be measured. This assumes that the temperature is not changing, but the temperature can also be monitored to correct for temperature fluctuations. Volume measurement by ultrasonic waves and pressure can be performed using a detection Foley catheter in the same way as temperature measurement. In this way, by using a detection Foley catheter in combination with a control unit, the urine specific gravity can be measured.

[0184] Reduction of condensation

[0185] Balloon catheters, especially those configured to remain in the body of a human or animal for a relatively long period of time, may leak over time. For example, a balloon inflated with air or another gas may leak air from the balloon over time. Alternatively, a balloon filled with liquid may leak liquid over time. The same is true vice versa. A balloon filled with gas or air present in a fluid such as urine or blood may leak fluid into the balloon over time. This is especially true when the balloon is inflated at a relatively low pressure.

[0186] The sensing Foley catheter is an example of a balloon configured to be inflated at a relatively low pressure for a relatively long time. In this example, if the balloon is configured to measure pressure, the balloon can be inflated at a relatively low pressure, and as a result, it may be made of a relatively flexible and thin material. Since the inflation pressure is low and the balloon material is flexible and thin, there is a possibility that liquid may leak into the balloon over time. The liquid in the pressure measurement balloon can particularly adversely affect very delicate pressure measurements, especially when the liquid migrates into the catheter lumen where the pressure measurement is being performed.

[0187] In one embodiment to solve this problem, a very small pore filter, i.e., a hydrophobic filter, is disposed between the pressure measurement balloon and the pressure measurement lumen of the catheter. This allows the balloon to be inflated, always primed to maintain pressure, and pressure measurements to be taken through the catheter lumen. Air and gas can pass through the filter, but fluid cannot.

[0188] Another embodiment includes forming the balloon from a low moisture permeability material.

[0189] Another embodiment includes refreshing the gas in the balloon by alternately applying vacuum and pressure to the balloon via one lumen or via two or more lumens.

[0190] Another embodiment includes circulating the gas in the balloon by providing access to the balloon through two or more lumens. One lumen may be used to introduce gas into the balloon, and the other lumen may be used to draw gas out of the balloon.

[0191] Another embodiment includes using a desiccant in the balloon, a balloon lumen, a gas supply to the balloon, or any combination thereof.

[0192] FIG. 35 is a diagram showing the distal end of a Foley-type balloon catheter that may benefit from reduced condensation. In this example, the balloon catheter is configured to be placed within a patient's bladder to assist in the drainage of urine from the bladder. The catheter has a retention balloon 3506 that secures the catheter within the bladder. The catheter shaft 3502 includes a plurality of lumens of the catheter. Through the opening 3504, urine within the bladder is drained through the catheter and can be discharged from the proximal end (not shown) of the catheter. The opening 3508 is for inflating and deflating the retention balloon. The pressure sensing balloon 3510 expands and contracts via the opening 3512. The pressure sensing balloon 3510 transmits a pressure signal through the pressure lumen within the catheter shaft from within the bladder to a pressure transducer proximal to the proximal end of the catheter.

[0193] Under certain circumstances, over time, fluid may leak into the pressure balloon 3510. Additionally, fluid may move from within the pressure balloon 3510 through the opening 3512 into the catheter shaft 3502. The fluid within the pressure lumen may affect the pressure measurement from the pressure balloon. As a result, it is desirable to prevent fluid from moving from within the pressure balloon through the opening 3512 and, if possible, reduce the amount of fluid entering the pressure balloon.

[0194] Figure 36 is a diagram showing a filter within a balloon according to one embodiment. Filter 3602 exists between the interior of balloon 3510 and the pressure lumen inside the catheter at opening 3512. Filter 3602 is preferably formed of a material that allows gas to pass through but does not allow fluid to pass through. For example, the filter can be formed from a hydrophobic membrane such as Versapor®, PTFE, ePTFE, etc. The filter can be formed from a polymer such as Nylon® or other suitable materials. The pore size can be about 3 micrometers, can be about 5 micrometers, can be in the range of about 0.2 micrometers to about 5 micrometers, or can be in the range of about 5 micrometers to about 10 micrometers. The thickness of the filter can be in the range of about 6 mils (about 0.1524 millimeters) to about 12 mils (about 0.3048 millimeters). Alternatively, the thickness of the filter can be in the range of about 1 mil (about 0.0254 millimeters) to about 6 mils (about 0.1524 millimeters). The pore size is related to the sensitivity of the balloon. For example, a filter with a pore size of 5 micrometers is suitable for a balloon inflated to about 5 mmHg to about 20 mmHg and may have the ability to detect a differential pressure up to a resolution range of 0.01 mmHg. If the sensitivity of the pressure measured via the pressure balloon is low, a smaller pore filter may be used. If it is necessary to make the pressure measured via the pressure balloon more sensitive, a larger pore filter can be used.

[0195] Figure 36 is a diagram showing a filter in the form of a tube that surrounds the catheter shaft at opening 3512 and completely covers the opening. The filter may have its ends adhered to the catheter shaft using any suitable adhesive or other means such as heat shrinkage. The seal between the filter and the catheter is ideally gas-impermeable so that the gas entering and leaving balloon 3510 through opening 3512 must pass through filter 3602.

[0196] Figure 37 shows another embodiment of the present invention, which includes a smaller catheter shaft with the filter attached inside the balloon. The catheter shaft 3704 inside the balloon has a smaller diameter than the catheter shaft 3706 that is not under the balloon. This can prevent the diameter of the inflated balloon from increasing due to the bulk of the filter 3702.

[0197] Figure 38 shows the embodiment shown in Figure 37 with the balloon deflated, and it can be seen that by reducing the diameter of the catheter shaft under the balloon region, significant bulging of the balloon catheter is prevented.

[0198] Figure 39 is a view showing a filter under the balloon according to another embodiment. The filter 3902 in this embodiment is not a filter that extends around the entire circumference of the catheter shaft. Instead, it is a flat or curved filter piece that is adhered to the catheter shaft via an adhesive or other suitable means. The adhesive preferably seals the filter around the entire circumference of its edge without infringing on the inflation / deflation / pressure measurement opening 3512 of the balloon.

[0199] Figure 40 is a view showing a short filter 4002 according to another embodiment.

[0200] Figure 41 is a diagram showing a balloon catheter equipped with a filter according to another embodiment. In this embodiment, the balloon catheter has two lumens that are in fluid communication with the balloon. The filter 4102 covers the opening 4104, but the opening 4106 is not covered. In this embodiment, the openings 4104 and 4106 may access individual lumens of the catheter, or may access the same lumen. In embodiments where they access individual lumens, balloon inflation, deflation, and pressure measurement may be performed via either lumen. For example, pressure measurement may be performed via the lumen in fluid communication with the opening 4106 until the accumulation of liquid in the lumen adversely affects the pressure measurement. At this point, the pressure transducer may be switched to the lumen in fluid communication with the opening 4104 so that pressure measurement can be performed through the lumen without liquid.

[0201] Alternatively, pressure measurement may be performed via the lumen in fluid communication with the opening 4106 until the accumulation of liquid in the lumen adversely affects the pressure measurement. At this point, gas may be introduced into the lumen in fluid communication with the opening 4106 to flush the fluid lumen. At the same time, gas may be withdrawn from the balloon via the lumen in communication with the opening 4104. In this way, the liquid may be flushed from the lumen in communication with the opening 4106, and pressure measurement may resume via that lumen. This line flushing procedure can be programmed to occur periodically.

[0202] Figure 41 shows two balloon openings 4104, 4106 on different sides of a catheter where the filter 4102 covers only one of the openings. Alternatively, Figure 42 shows an embodiment similar to Figure 41, except that the two openings 4204, 4206 may be arranged such that the filter 4202 covers only one of the openings.

[0203] Figure 43 is a diagram showing an embodiment of the present invention in which filter 4302 covers a larger opening 4304. A larger opening may be desirable in order to obtain a more accurate pressure measurement value from the balloon. In addition, the addition of filter 4302 may allow for a larger opening due to the additional alignment provided by the filter, and perhaps its adhesive means, to the area of the catheter around opening 4304.

[0204] Figure 44 is a diagram showing an embodiment of the present invention in which filter 4402 is attached to the catheter shaft via heat shrink tube segment 4404. This allows for an airtight seal between the filter and the catheter while ensuring that catheter opening 4406 remains clean.

[0205] Figure 45 is a diagram showing an embodiment similar to Figure 44 in which the catheter shaft tapers below the balloon region. This allows the balloon to be deflated without causing a bulge in the catheter to which the filter is attached. Filter 4502 is attached to the catheter shaft via heat shrink tube segment 4504. This allows for an airtight seal between the filter and the catheter while ensuring that the catheter opening remains clean.

[0206] Figure 46 is a diagram showing an embodiment of the present invention in which filter 4602 is attached inside the opening of the catheter.

[0207] FIG. 47 is a diagram showing an embodiment of the present invention in which a balloon has two access lumens 4702 and 4704. In this embodiment, the balloon catheter has two lumens in fluid communication with the balloon. In this embodiment, the openings 4702 and 4704 may access individual lumens of the catheter or the same lumen. In embodiments where they access individual lumens, balloon inflation, deflation, and pressure measurement may be performed via either lumen. For example, pressure measurement may be performed via the lumen in fluid communication with the opening 4702 until the accumulation of liquid in the lumen adversely affects the pressure measurement or for a set period. At this point, gas may be introduced into the lumen in fluid communication with the opening 4702 to flush the fluid lumen. At the same time, gas may be withdrawn from the balloon via the lumen in communication with the opening 4704. The reverse is also true, i.e., fluid may be introduced into the lumen in fluid communication with the opening 4704 and removed from the lumen in fluid communication with the opening 4702. In this way, the liquid is flushed from the lumen in communication with the opening 4702 and pressure measurement may resume via that lumen. This line flushing procedure can be programmed to occur periodically. The openings 4702, 4704 are shown here facing each other, but the openings may be staggered.

[0208] FIGS. 48 and 49 are diagrams showing the configurations of two different pressure balloons, although at least either one of any suitable configuration and shape may be used. Depending on the material of the balloon, the manufacturing method of the balloon may be different. Depending on the material, some are suitable for blow molding and some are suitable for dip molding. Other manufacturing techniques, such as resistance heat sealing, can also be used similarly. FIG. 48 is a diagram showing an example of a blow-molded balloon. FIG. 49 is a diagram showing an example of a dip-molded balloon.

[0209] Some examples of materials from which the balloon can be manufactured include urethane, polyurethane, polyethylene, nylon®, polyvinylidene fluoride, or any other suitable polymer or other material, or any combination of materials.

[0210] Also, a balloon coating may be utilized to reduce the fluid permeability of the balloon. Examples of such coatings include poly(p-xylylene) polymers, or parylene.

[0211] In some embodiments, it is desirable to prevent any water vapor from entering the pressure balloon. In these embodiments, water, or a fluid-impermeable material, may be used for the balloon. Some of the materials described herein are suitable. Additionally, biaxially oriented polyethylene terephthalate (BoPET), often sold under the trade name Mylar®, can be used. Also, metallized polymers and other suitable materials may be used.

[0212] In some embodiments, the sensing Foley catheter reports the presence of water droplets or other obstructions within a lumen filled with air (e.g., a pressure lumen), and is then configured to process or resolve the water droplets. In particular, in a hypothermic environment, moisture within 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) may disrupt or complicate pressure signals due to the surface tension of the water. Thus, the pressure transmission lumen in some embodiments of the disclosed technology may include hydrophilic elements (e.g., a coating on the wall of the lumen itself, or hydrophilic fibers extending the length of the lumen) to keep moisture away from the lumen in order to maintain a continuous and unbroken air channel. In some embodiments, a hygroscopic composition (e.g., silica gel) may 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 may be included within the catheter so that there is no need to service the air injection circuit to replace this material.

[0213] In some embodiments, dry air or gas may be used within the pressure lumen and pressure balloon to prevent the accumulation of moisture.

[0214] In some embodiments, a hydrophobic or hydrophilic coating may be used on at least one of the pressure lumen and the pressure balloon.

[0215] Gas content

[0216] Another embodiment includes measuring the relative oxygen or other gas content of urine or tissue using a hydrophobic filter or membrane as an interface with the urine within the bladder or the mucosal lining of the urethra.

[0217] In some embodiments of the detection Foley catheter, it is desirable to measure gas-containing tissues and / or urine, or changes in gas content over time. Gases that may be of interest include oxygen, carbon dioxide, nitrogen, gases associated with anesthesia, or other gases. In some embodiments, the membrane is permeable to gases but not to liquids, and for example, a hydrophobic membrane or other suitable membrane may be used. The pore size of the hydrophobic membrane may be about 5 micrometers. Alternatively, the pore size of the hydrophobic membrane may be from about 3 micrometers to about 7 micrometers.

[0218] Figure 50 is a diagram showing a detection Foley catheter having an oxygen permeable membrane. The retention balloon 5002 is in fluid communication with the inflation / deflation port 5010. Urine flows through the catheter through the opening 5004 and out of the port 5012 that is in fluid communication with the opening 5004. The pressure sensing balloon 5006 is in fluid communication with the lumen 5014. The gas permeable membrane 5008 covers the opening at the distal end of the catheter that is in fluid communication with the lumen 5016.

[0219] Figure 51 is a diagram showing a detection Foley catheter having an oxygen permeable membrane similar to that shown in Figure 50, except that the membrane 5108 is between the pressure sensing balloon 5106 and the retention balloon 5102. The opening 5104 for urine may be located anywhere on the distal side of the retention balloon 5102.

[0220] Figure 52 is a diagram showing a detection Foley catheter according to an embodiment in which the membrane 5204 is incorporated into the gas sensing balloon 5202. In this figure, the gas sensing balloon 5202 is distal to the pressure sensing balloon 5206, but another embodiment is shown in Figure 53, in which this is not the case. The gas sensing balloon 5202 may be formed from silicone, polymer, or any other suitable material.

[0221] The membrane material may be similar to the hydrophobic membrane materials described in other embodiments of this specification. The membrane is permeable to gases, i.e., one or more specific gases, but impermeable to liquids such as urine. Thus, gases can pass through the membrane and enter the catheter to measure the gas content of tissues and / or urine, and / or the change in gas content over time. The measured gases include gases such as oxygen, nitrogen, and carbon dioxide.

[0222] The catheter may be placed inside the patient such that the membrane is in either the bladder or the urethra. The membrane is shown here on a sensing Foley catheter having a pressure sensing balloon, but the gas permeable membrane may be placed on any intravascular catheter, including catheters present in blood vessels or other body cavities. The membrane may be in direct or indirect contact with fluids, gases, or body tissues.

[0223] Figure 54 is a diagram showing a control unit for controlling the measured values of oxygen or one or more other gases. The control unit is generally placed outside the patient's body and is connected to the catheter via a port, for example, a port connected to lumen 5016. Also, the control unit may control functions such as the pressure sensing function of the sensing Foley catheter, or it may be a separate control unit.

[0224] Here, the gas measurement control unit 5402 is shown together with the representation of the catheter 5404 and the gas transfer membrane 5406. The gas measurement control unit 5402 includes air or gas, an inlet 5408, air or gas, an exhaust 5410, a pump 5412, an oxygen or other type of sensor 5414, and a check valve 5416.

[0225] In this embodiment, the pump 5412 periodically pushes a small amount of air or other gas into the catheter through a tube. The air passes through the membrane "window" 5406, and the oxygen content of the air changes based on the oxygen content of the mucosal lining (when the gas transfer membrane is in the urethra) or urine (when the gas transfer membrane is in the bladder). Further downstream (returning into the gas measurement control unit box 5402), an optical fiber or other type of oxygen sensor is used to measure the proportion of oxygen in the air. The pump may operate for only a short time to ensure that the air in the system has time to equilibrate with the tissue / fluid.

[0226] The check valve 5416 helps prevent the air that has passed through the system from mixing with the outside air or the air from previous measurement intervals.

[0227] The measured oxygen or other gas content may be very low. The measurement can indicate either an absolute gas level or a relative gas level. For example, the measurement value of the gas measurement control unit may show the relative oxygen content within the patient over time to indicate changes in the patient's condition.

[0228] Figure 55 is a schematic diagram showing a method in which a gas measurement control unit interacts with a catheter to measure the gas content of urine or patient tissue. The catheter 5502 includes a urine drainage lumen 5504 and gas measurement lumens 5506, 5508, which are in fluid communication with a gas transfer membrane 5510. Lumen 5506 contains air or other gas entering the catheter, and lumen 5508 contains air or other gas exiting the catheter after the carrier gas has passed through the gas transfer membrane. To determine the oxygen level or change in oxygen level in at least one of the patient's urine and tissue, the level of oxygen or other gas in the exiting gas is measured. The incoming gas measurement lumen 5506 may be open to the atmosphere or other source, or the gas within lumens 5506 and 5508 may be circulated continuously, such that it may be a closed system so that changes in gas content can be easily determined over time. That is, the air, or gas, inlet 5408 and the air, or gas, exhaust 5410 in FIG. 54 may be fluidly connected to each other.

[0229] When the incoming gas measurement lumen 5506 is open to the atmosphere, the pump may be operated intermittently so that the gas within the gas measurement lumen has more time to equilibrate across the membrane surface. As a result, the intermittent concentration of the measurement gas is increased, thereby enabling a more sensitive measurement.

[0230] The pump can be operated continuously or intermittently regardless of whether the system is closed or open, but more sensitive measurement results will be obtained if the system is operated intermittently in the open mode. In the closed system mode, the trend will become more apparent as the measurement gas within the system equilibrates with the gas level of the urine, body fluid, or tissue being measured.

[0231] In this embodiment, the urine lumen and the gas measurement lumen are separate. However, the gas transfer membrane may also be located between the urine lumen and the gas measurement lumen, as shown in FIG. 56, and the gas transfer membrane 5602 is in fluid communication with the urine lumen.

[0232] FIGS. 57A and 57B are diagrams showing embodiments of the gas measurement addition member. The gas measurement member 5702 may be inserted between the sensing Foley catheter 1000, or any Foley catheter, and the urine drainage tube 1001, or any urine drainage tube. The gas measurement member 5702 includes a hydrophobic filter 5704, which may be formed from materials disclosed elsewhere in this specification. Through the gas inlet lumen 5706 and the gas outlet lumen 5708, gas can pass over the filter 5704 that is in gas communication with the urine in the drainage system. The air, or gas, near the filter 5704 equilibrates very rapidly with the gas in the urine within the drainage system. FIG. 57B is a diagram showing the path of the air flow across the filter 5704. The gas outlet lumen 5708 is in fluid communication with a control unit (not shown here) that analyzes the gas within the lumen for one or more relevant gases. The gas inlet lumen 5706 may be open to the atmosphere, another gas, or may be in a closed loop with the gas outlet lumen 5708 within the control unit. The control unit may be the same control unit that measures the urine volume described elsewhere in this specification, or it may be a separate control unit. The lumens 5706, 5708 may be incorporated into the drainage tube 1001 or may be separate. The gas measurement member 5702 may be a separate member as shown here, or may be incorporated into the vent valve 1016. Instead, the gas measurement member 5702 may be placed anywhere within the system.

[0233] Detection / Judgment of Specific Symptoms

[0234] FIG. 58A shows a table listing combinations of parameters that enable fingerprints or signatures (combinations of parameters) for different indicators of AKI (prerenal, intrinsic, and obstructive). In addition, there may be fingerprints or signatures regarding the timing of parameter changes, which may also determine the cause of AKI (for example, in intrinsic AKI due to glomerulonephritis and intrinsic AKI due to acute tubular necrosis, it is reasonable that some parameters change more rapidly). This multi-parameter approach can facilitate the selection of an effective treatment for AKI because the effective treatment varies depending on the cause of AKI (for example, recombinant alkaline phosphatase is effective for the treatment of intrinsic (sepsis) AKI but not for non-sepsis AKI).

[0235] FIG. 58B is a table listing combinations of parameters that enable fingerprints or signatures (combinations of parameters) for different indicators of sepsis, AKI, and acute respiratory distress syndrome (ARDS). These signatures include increases, decreases, or both of various patient parameters such as urine output, heart rate, respiratory rate, body temperature, stroke volume, and abdominal perfusion pressure. Abdominal perfusion pressure is the mean arterial pressure (MAP) minus the intra-abdominal pressure (IAP). The mean arterial pressure is equal to the diastolic pressure (DP) plus one-third of the pulse pressure (PP). (The pulse pressure is equal to the systolic pressure minus the diastolic pressure). In short, MAP = DP + 1 / 3PP.

[0236] Other patient parameters may be used. One, some, or all of the relevant parameters may be used by the control unit to communicate at least one of the diagnosis and risk to the user or another device. Patient parameters captured by the sensing Foley catheter system can be used by themselves or in combination with parameters obtained elsewhere, such as information from an electrocardiogram, a blood pressure measuring device, or an EMR.

[0237] The detection Foley catheter system monitors real-time, automatic, and precise physiological parameters for the early detection of various medical conditions. By using real-time multivariate analysis (point values) and time-series analysis (trends) of these high-frequency data streams to provide information to a machine learning-based model, highly sensitive physiological markers for the early onset of sepsis (or other medical condition determination) may be developed. This enables early diagnosis and intervention, improving clinical outcomes. Markers related to data associated with physiological changes occurring before and / or during the onset of a particular medical condition can be continuously improved using machine learning via artificial neural networks to strengthen relevant parameters, weaken less relevant parameters, and build or break connections. This allows the control unit to use algorithms to distinguish between medical conditions and between normal pathology and other pathologies.

[0238] In some embodiments of the present invention, urine volume may be measured immediately after administering a diuretic to a patient. This type of test can be a strong indicator of whether a patient with AKI will progress to a more severe stage and / or die. If a patient's urine volume increases after diuretic administration, it indicates that the patient is less likely to progress to a more severe stage of AKI. If a patient's urine volume does not increase significantly after diuretic administration, this indicates that the patient is more likely to progress to a more severe stage of AKI. According to the present invention, urine volume can be measured 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 techniques.

[0239] This test can be automated using a control unit that provides a controlled dose of a diuretic and then monitors urine output over several minutes, or hours, preferably only a few minutes. The diuretic administered may be furosemide, or other suitable loop diuretics or other diuretics. 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, a diuretic can be administered and data collected. This document is hereby incorporated by reference in its entirety.

[0240] In addition to detecting AKI, the present invention can detect urinary tract infections (UTIs) indicated by a decrease in oxygen tension, a decrease in carbon dioxide levels, an increase in specific gravity, and relatively stable urine volume and conductance. By combining urinary markers to create a UTI fingerprint, it is possible to detect UTIs even in the absence of AKI and, in some cases, even in the presence of AKI. The UTI fingerprint can alert a physician to the presence of a UTI.

[0241] In addition to detecting AKI and UTI using the 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 conductance (UC), urine output (UO) and / or stroke volume (SV), which are already used to detect conditions such as intra-abdominal hypertension (IAH), abdominal compartment syndrome (ACS) and sepsis. By adding IAP, RR, HR, CO, RSV, Temp, PP, UC, UO and / or SV measurements to the algorithms described herein, the sensitivity and specificity for detecting AKI or UTI are increased. On the other hand, by adding the measurements obtained in the present invention to the IAP, RR, HR, CO, RSV, Temp, PP, UC, UO and / or SV measurement algorithms, the sensitivity and specificity for detecting IAH, ACS or sepsis may be increased. Other clinical applications include the treatment of trauma and burns.

[0242] In addition to the absolute measurements of IAP, RR, HR, CO, RSV, Temp, PP, UC, UO, gas concentration and / or SV, data on the trends of these parameters can also be used to detect IAH, ACS, sepsis or other conditions. For example, the slope of the values of these parameters over time and / or the variability of the values of the parameters over time may be used. Another example of using data trends is the use of pulse pressure waveform analysis and pulse wave velocity (or pulse transit time). Pulse transit time can be measured by capturing a cardiac signal such as an electrocardiogram from leads on a sensing Foley catheter and / or other locations and measuring the time it takes for the pulse pressure signal to travel to the bladder. At least one of a plurality of parameters and the trends of the parameters may be used to determine the presence of IAH, ACS, sepsis or other conditions.

[0243] Examples of the use of trend data include the following.

[0244] - If UO is decreasing when vital signs are stable (or not), it may indicate acute kidney injury. If the stroke volume is decreasing, the kidneys may be ischemic. If urine output suddenly increases while vital signs are stable, it may indicate toxic acute kidney injury.

[0245] - If the respiratory rate is increasing as the stroke volume decreases, it may indicate pulmonary embolism, hemorrhage, or other volume depletion.

[0246] If the respiratory rate is increasing while vital signs are stable, it may indicate impending airway obstruction.

[0247] - If the respiratory rate is decreasing while other parameters are stable, it may indicate opioid overdose. This is a major problem with analgesics used in patient management.

[0248] - If the intra-abdominal pressure (IAP) is rising and urine output is increasing while the stroke volume is stable, it may be an indicator of impending fluid overload.

[0249] - An increase in IAP associated with a decrease in UO and a decrease in cardiac output may be an indicator of cardiorespiratory dysfunction. This may be caused by fluid overload, sepsis, etc.

[0250] The present invention can be used in various hospital settings (e.g., emergency rooms, operating rooms, intensive care units, hospital wards). At any time, this device can be used to monitor the progression of AKI, whether it is improving or deteriorating. Its algorithm warns physicians of newly diagnosed cases of AKI and changes in the state of AKI. This device may be placed before damage to the kidneys occurs (e.g., to detect whether a patient undergoing heart surgery is starting to suffer kidney damage during the surgery) to detect the onset of AKI. It may also be placed if there is already damage to the kidneys to determine the extent of the damage at that time. This device may also be used to monitor the response to treatment / treatment intervention (e.g., renal replacement therapy, fluid resuscitation, etc.).

[0251] Alternative embodiments

[0252] In an embodiment of the present technology, in the detection or diagnosis of paroxysmal disorders, the movement of the patient may be reported. In this embodiment, pressure fluctuations may trigger an electroencephalogram or recording device to enable intense monitoring during episodes suspected of being seizures. Additionally, or alternatively, pressure sensors, acoustic sensors, or other sensors may be used to detect peristaltic movement, patient movement, spastic activity, patient tremors, cough frequency, cough severity, sleep duration, sleep quality, voice detection, patient compliance (movement or lack thereof), and warn medical staff that the patient is not moving and needs to turn over or roll over. Also, this movement-related information may be relayed to devices such as hypothermia devices, drug delivery devices, etc. to control or alleviate seizure activity, tremors, and / or coughs.

[0253] In some embodiments, the sensing Foley catheter reports the presence of water droplets or other obstructions within a lumen filled with air (e.g., a pressure lumen) and is then configured to process or resolve the water droplets. In particular, in a hypothermic environment, moisture within the air lumen can 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 pressure signals due to the surface tension of water. Thus, the pressure transmission lumen in some embodiments of the disclosed technology may include hydrophilic elements (e.g., a coating on the wall of the lumen itself, or hydrophilic fibers extending the length of the lumen) to keep moisture away from the lumen in order to maintain a continuous and unbroken air channel. In some embodiments, a hygroscopic composition (e.g., silica gel) may 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 may be included within the catheter such that there is no need to service the air injection circuit to replace this material.

[0254] In some embodiments of the disclosed technology, as described in further detail above, air may be intermittently (automatically) injected into and withdrawn from the pressure sensing balloon such that the balloon is in a certain state where it is optimally primed. In the case of wicking fibers or hydrophilic coatings within the lumen, air withdrawal can also contribute to removing and capturing any water from the air line. In the example of a liquid-filled lumen, providing a hydrophilic fiber or hydrophilic coating on the inside of the pressure lumen provides similar advantages in enabling this lumen to process air bubbles. In this example, although air bubbles can potentially distort the signal, the surface tension at the air-water interface is dissipated by the hydrophilic coating within the lumen of the catheter.

[0255] 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 catheter may have a lumen with a star-shaped cross-sectional shape. Such lumens are generally immune to blockage by water droplets because the water droplets tend to aggregate on themselves and be pushed away from the hydrophobic walls. This behavior tends to void the filling of the cross-sectional space, maintaining air channels around the water droplets and enabling communication to the sensor. The same logic applies to air bubbles in water within a hydrophilic star-shaped water lumen. In this example, the hydrophilic liquid adheres to the walls, allowing for a continuous water column that excludes air bubbles from the center of the lumen. The same is true when a hydrophobic liquid is in a hydrophobic lumen. In some embodiments, the catheter may include an air channel and a sensor incorporated within the catheter body or within a fluid lumen capable of returning pressure to the sensor.

[0256] The drainage tube may be a multi-lumen tube for accommodating a urine drainage line, a pressure lumen, and thermocouple wires, with one end connected to a barb and the other end connected to a control unit.

[0257] The Foley catheter may be extruded with BaSO4 or may be attached with a radiopaque marker for fluoroscopic observation.

[0258] The thermistor disposed at the tip of the catheter may be fixed in place using a number of extrusion profiles and assembly techniques.

[0259] In some embodiments, the sensing Foley catheter can include a blood pressure sensing element that can take any of several forms. In one embodiment, the blood pressure sensing element is a pressure delivery balloon (either an individual dedicated balloon or a balloon in fluid communication with a device holding balloon or pressure sensing balloon) that can be optically analyzed when inflated to determine at what pressure the blood vessels in the bladder or urethra are blanched and blood flow is stopped. This approach reads the perfusion pressure of the tissue adjacent to the pressure delivery balloon, and such readings reflect both systemic blood pressure and vascular resistance. The perfusion pressure device of this embodiment can be used to early detect or monitor various acute or critical medical conditions such as sepsis, shock, hemorrhage, etc., and can be particularly advantageous for early detecting these conditions. In predicting sepsis, embodiments of the present invention can receive white blood cell count information to better predict sepsis.

[0260] Other modalities may similarly be used to detect when tissue is blanched or ischemic, and a common methodological aspect is to intermittently inflate 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 the perfusion pressure of other areas of the body using an intermittently inflatable member and to optically detect blood flow or the presence of blood.

[0261] Tissue perfusion information may be provided by sensors disposed on the catheter shaft to contact the urethral wall when the catheter is in a predetermined position. These sensing techniques can include microdialysis, pyruvic acid, lactic acid, pO2, pCO2, pH, perfusion index, near-infrared spectroscopy, laser Doppler flowmetry, urethral capnography, and orthogonal polarization spectroscopy. Any of these tests may be performed on urine or the bladder wall itself to generate a measurement of tissue perfusion.

[0262] Another embodiment of the detection Foley catheter system includes a dissipation ring mechanism according to one embodiment that includes at least one of an apparatus and a port for a positive air flow near the starting point of the drainage line. The positive air flow promotes drainage by forcing urine into the drainage line. The positive air flow apparatus may include a one-way valve at the end of the urine catheter to prevent air from entering the catheter and to allow urine to flow only towards the urine collection device.

[0263] In some embodiments, the urine cleaning mechanism includes a coating on the inside of the urine drainage tube to reduce surface tension and promote drainage. In one aspect, the coating is a hydrophobic polymer including, but not limited to, PTFE or FEP.

[0264] In yet another embodiment, the dissipation ring mechanism includes a tubular hydrophobic vent filter that can be inserted into the drainage lumen of the device so that air is evacuated throughout its length. Segmented hydrophobic vents can also be incorporated at set intervals so that air is reliably discharged from the tube as it passes through these regions. In this embodiment, the hydrophobic vents are spaced at intervals of at least 1 to 2 feet (about 0.30 to 0.60 meters) to prevent submersion of the vents in urine. By providing redundancy, multiple vents / filters prevent failure of one filter / vent due to its submersion. In an ideal configuration, the vents are made of PTFE or ePTFE material and will be fixed to the tube with barbs or grommets at spaced intervals to facilitate manufacture. In an alternative embodiment, the vents take the form of slits or spirals through the length of the drainage tube, whereby air can escape from the tube at any point. This can prevent position-dependence of the drainage tube during prevention and / or elimination of air locks.

[0265] In an alternative embodiment, the airlock is prevented by an expandable drainage tube that forms an air pocket in the upper portion of the tube and prevents urine from collecting in the lower portion. The expandable tube can prevent such a situation by keeping the tube as straight as possible between the urethral catheter and the urine collection bag. In one aspect, the expandable drainage tube is configured to have a plurality of telescoping sections that can be expanded or folded according to the distance from the patient to the collection bag. In another aspect, the drainage tube is pleated to form an accordion and can be expanded or folded or deformed as needed. In yet another aspect, the tube is coiled. In yet another aspect, the drainage tube can be retracted by a spring coil that wraps the tube around a wheel to an appropriate length.

[0266] Also, the relative cardiac output and the relative minute ventilation may be calculated based on the deflection of at least one of the pressure sensor and the other force gauges. When sampled at a sufficient frequency (e.g., 1 Hz or higher), the respiratory movement can be quantified in a relative way with the amplitude of the movement during catheterization. Larger movements are generally associated with increased peritoneal pressure in settings where breathing is heavier or the baseline drifts upward. Small peaks on the oscillatory respiratory wave caused by the pulsating heart may be similarly tracked using a faster sampling rate (e.g., 5 Hz or higher), and the amplitude of this wave may be used to measure the relative cardiac output in settings of a relatively constant peritoneal pressure, a well-known stable peritoneal pressure, an absolute stroke volume, and / or a cardiac output setting.

[0267] The intraperitoneal pressure or bladder pressure detected by one embodiment of the disclosed technology may be used to detect the level of a patient's movement (e.g., such that it can vary between a state of substantially no movement to a high level of movement) and report the level of movement to a healthcare provider. Short bursts of peaks and valleys in bladder pressure activity can function as a proxy for body movement in that such bladder pressure profiles are a strong indicator, for example, of whether a patient is sitting or using abdominal muscles to get out of bed. This embodiment may be particularly beneficial for patients at risk of falling. In the case of a patient at risk of falling, a healthcare provider may be notified that the patient is sitting and may respond accordingly. Alternatively, the device may be used to report at least either the patient's inactivity or the lack of patient movement.

[0268] A plurality of pulse oximetry elements can determine blood oxygen concentration or blood oxygen saturation, and the elements can be placed anywhere along the length of the urethra 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. This technique allows a healthcare provider to decompress the bladder with a urethral catheter and repeatedly and accurately obtain pulse oximetry data. The power source for pulse oximetry may be incorporated within the urine collection receptacle or within 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 a disposable catheter and removed when oxygen measurement is no longer desired. Embodiments of the sensing Foley catheter may include an optically transparent, or sufficiently transparent, channel for the oximetry signal, such as an optical fiber cable, a transparent window, and an interface for a reusable oximeter. This method and apparatus for urethral pulse oximetry may be used in combination with any of the other embodiments detailed herein or used alone.

[0269] To prevent infection, an antimicrobial coating or a material impregnated with an antimicrobial compound may be used on the sensing Foley catheter. Examples of antimicrobial coatings / materials include silver, silver citrate, parylene, or other suitable materials.

[0270] Pulmonary blood volume variations can also be determined by a sensing Foley catheter system to assist in the assessment of the presence or risk of heart failure. When left ventricular function deteriorates, the pulmonary blood volume (PBV) increases or the variation in pulmonary blood volume decreases. PBV variation is defined as the change in PBV over time during the cardiac cycle. PBV can be determined as the product of cardiac output and pulmonary transit time (PTT). Cardiac output can be determined as the product of stroke volume and heart rate, where stroke volume is the area under the flow-time curve for one cardiac cycle. Pulse transit time may 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 may be obtained from an individual electrocardiogram lead, a lead incorporated into the sensing Foley catheter, a lead incorporated into the catheter insertion kit, or elsewhere. Electrocardiogram leads may also be able to read electrocardiogram signals from urine anywhere within the system. Two leads may be used to more accurately measure the pulse transit time.

[0271] It has been shown that after myocardial infarction, stroke volume, ejection fraction, and PBV variation decrease, with the greatest change seen in PBV variation. Therefore, determining PBV variation and identifying a decrease in PBV variation may strongly indicate heart failure or the risk of heart failure.

[0272] Data collected by the detection Foley catheter system may be stored in a database and analyzed for trends or other purposes. The data may include at least one of clinical data and device data. For example, data can be collected from multiple patients, aggregated anonymously, and used to predict better treatment, monitoring, or future patient behavior. For example, data collected over time related to heart rate, respiratory rate, body temperature, infection, etc. may be aggregated by the control unit and analyzed to find trends such as the relationship between various parameters and results. For example, a particular trend in temperature may be a predictor of infection, onset of sepsis, ARDS, and / or AKI, either alone or in combination with other parameters. FIG. 58 shows some well-known examples, but other, currently unknown trends may emerge from the aggregated patient data.

[0273] Data collected by the detection Foley catheter system may be integrated with an electronic health record (EHR) or electronic medical record (EMR) and / or other systems. Data collected by the detection Foley catheter system control unit may interface directly or indirectly 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.

[0274] Examples of data processing systems

[0275] FIG. 60 is a block diagram showing a data processing system that can be used in any embodiment of the present invention. For example, system 6000 may be used as part of a control unit, as shown in some embodiments herein. FIG. 60 illustrates various components of a computer system, but is not intended to represent a particular architecture or method of interconnecting the components, and thus such details are not closely related to the present invention. Also, network computers, handheld computers, mobile devices, tablets, cell phones, and other data processing systems having fewer or perhaps more components may also be used in combination with the present invention.

[0276] As shown in FIG. 60, a computer system 6000, which is an embodiment of a data processing system, includes one or more microprocessors 6003, a ROM 6007, a volatile RAM 6005, and a bus or interconnect 6002 coupled to a non-volatile memory 6006. The microprocessor 6003 is coupled to a cache memory 6004. The bus 6002 interconnects these various components and also interconnects these components 6003, 6007, 6005, 6006 to a display control unit and a display device 6008, and to input / output (I / O) devices 6010 such as a mouse, keyboard, modem, network interface, printer, and other devices well known in the art.

[0277] Typically, the input / output device 6010 is coupled to the system via the input / output control unit 6009. The volatile RAM 3605 is typically implemented as a dynamic RAM (DRAM) that continuously requires power to refresh or maintain data in the memory. The non-volatile memory 6006 is typically a magnetic hard drive, a magneto-optical drive, an optical drive, or a DVD-RAM or other type of memory system that maintains data even after power is removed from the system. Usually, the non-volatile memory, although not necessarily, can also be a random access memory.

[0278] FIG. 60 shows that the non-volatile memory is a local device directly coupled to the rest of the data processing system, but 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 (registered trademark) interface may be used. The bus 6002 may include one or more buses connected to each other via various bridges, control units, and / or adapters, as is well known in the art. In one embodiment, the I / O control unit 6009 includes a USB (Universal Serial Bus) adapter for controlling USB peripheral devices. Alternatively, the I / O controller 6009 may include an IEEE-1394 adapter, also known as a FireWire (registered trademark) adapter, for controlling FireWire (registered trademark) devices.

[0279] Part of the foregoing detailed description has been presented from the perspective of algorithms and symbolic representations of operations on data bits in a computer memory. These descriptions and representations of algorithms 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 operations leading to a desired result. The operations are those requiring physical manipulation of physical quantities.

[0280] However, it should be borne in mind that all of these terms and similar terms should be associated with appropriate physical quantities and are merely convenient labels applied to these quantities. As is apparent from the above discussion, unless otherwise specified, throughout this specification, discussions using terms as set forth in the following claims refer to a computer system's operation and process of manipulating and transforming data represented as physical (electronic) quantities in the registers and memories of the computer system into other data similarly represented as physical quantities in the computer system's memory or registers, or in other such information storage devices, transmission devices, or display devices, or a similar electronic computing device.

[0281] The illustrated technology can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices can use computer-readable media such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read-only memory; flash memory devices; phase change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustic, or other forms of propagated signals - carrier waves, infrared signals, digital signals, etc.) to store the code and data and communicate (internally and / or with other electronic devices via a network).

[0282] The processes or methods depicted in the foregoing figures 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. It should be understood that although the processes or methods have been described above in terms of several sequential operations, some of the operations described may be executed in a different order. Further, some operations may be executed in parallel rather than sequentially.

[0283] 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 methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. Some embodiments of the present invention have been described in detail with the use of figures, but such figures are for the sole purpose of clarifying understanding and are not intended to be limiting. Various terms have been used in this specification to convey an understanding of the present invention, and it will be understood that the meanings of these various terms extend to general linguistic or grammatical variations. Furthermore, although some theoretical considerations may have been advanced to provide an understanding of this technology, 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. Moreover, it should be understood that the present invention is not limited to the embodiments described for illustrative purposes and is defined only by a fair reading of the claims appended to the patent application, which includes the full scope of equivalents to which each element is entitled.

[0284] In some embodiments of the detection Foley catheter system, sterilizing the urine collection chamber itself or other components of the system using ultraviolet light, or light of an appropriate wavelength, is included. The ultraviolet light source may irradiate ultraviolet light directly through the wall of the urine collection chamber, or alternatively, the ultraviolet light source may be disposed inside the urine collection chamber. The ultraviolet light source may be used to sterilize the urine collection chamber when the chamber is empty, full, or partially full. When urine enters the urine collection chamber, the urine may be sterilized using the ultraviolet light source. The ultraviolet sterilization process may be performed continuously or intermittently. The ultraviolet light source may be disposed at any location within the detection Foley catheter system. Ultraviolet light, or light of other wavelengths, can be used within the bladder.

[0285] Spectroscopy - Spectrophotometry

[0286] Some embodiments of the detection Foley catheter system include using light wavelengths in the range of about 520 nm to about 650 nm to identify bacteria, red blood cells, and / or plasma / white blood cells. Refer to the area inside the ellipse in Figure 61.

[0287] Some embodiments of the detection Foley catheter system include combining spectrophotometry for identifying white blood cells and bacteria in combination with identifying at least one of a decrease in pO2 and an increase in CO2 for identifying infectious diseases.

[0288] In some embodiments of the detection Foley catheter system, the control unit includes filtering urine volume data to compensate for the increased urine volume immediately after administration of a diuretic. Generally, the urine volume increases immediately after administration of a diuretic. However, in certain situations, it may be beneficial to essentially ignore the increased urine volume data associated with the administration of a diuretic. The control unit of the detection Foley catheter system 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. The identification of the shape of the curve may be performed by the slope, length of the increase, amplitude of the increase, shape, etc. Subtraction of diuretic-induced urine volume data may be beneficial in determining or predicting the onset of AKI. Refer to Figure 62. For example, when the urine volume rises above about 2000 mL / hour (peak), the control unit may recognize that a diuretic has been administered.

[0289] The increase in urine volume due to the administration of a diuretic can be distinguished from the increase in urine volume due to the clamping of at least one of the urinary drainage tube and the Foley catheter, or occlusion by other means. In a situation where the drainage lumen is clamped, the urine volume before the increase is substantially zero, or very low, 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 may be very low, but is likely to exceed zero, for example, it will exceed about 5 ml / hour. In addition, in a situation where the drainage lumen is clamped, the increase in urine volume after the release of the clamp on the drainage lumen will be for a relatively short period of time, for example, about 30 seconds to about 5 minutes. In contrast, in a situation where a diuretic is administered, the increase in urine volume will extend over a longer period of time, for example, about 30 minutes to about 2 hours. In addition, in a situation where the drainage lumen is clamped, the urine volume after the release of the clamp on the drainage lumen is likely to be less than about 1000 mL. Conversely, in a situation where a diuretic is administered, the urine volume after the administration of the diuretic is likely to exceed about 1000 ml. Any or all of these factors may be used by the control unit to analyze the urine output on the time curve to determine the time when the diuretic was administered, and to subtract the increased urine output due to the diuretic from the urine volume presented to the user.

[0290] In this way, the control unit may automatically determine the administration time of the diuretic. Alternatively, the user interface of the control unit may include a button or other user input device (such as a touch screen, voice control, etc.) indicating that the diuretic has been administered. Then, the control unit will look for the increased urine volume and subtract the increased urine volume due to the diuretic from the urine volume data presented to the user.

[0291] Some embodiments of the detection Foley catheter system include a control unit that determines the abdominal perfusion pressure (APP). The APP is defined as the difference between the mean arterial pressure and the intra-abdominal pressure (IAP). The mean arterial pressure can be determined by conventional methods and can be combined with the determination of the IAP by the control unit to determine the APP. The control unit can further automatically change the infusion of fluids and / or pressurizers / basopressors to increase or decrease blood pressure.

[0292] Prevention of wetting of the filter / vent

[0293] In some embodiments of the detection Foley catheter system, at least one of one or more vents and filters is included to prevent negative pressure from accumulating in the Foley catheter and causing suction trauma to the bladder. The filter / vent may also be disposed at the junction of the Foley catheter and the drainage tube or elsewhere, such as within the urine collection container, or within the lumen of the drainage tube or the Foley catheter itself, as described below.

[0294] The filter / vent in some embodiments is configured to repel fluid, i.e., a hydrophobic material. However, despite using a hydrophobic material, the filter / vent is susceptible to wetting by fluids, particularly urine. In some embodiments, a larger lumen, i.e., lumen area, in which the filter / vent is disposed is included to reduce the likelihood that fluid 6302 fills the lumen due to the surface tension of the fluid. FIG. 63A shows a small-diameter lumen, whereas FIG. 63B shows a larger-diameter lumen in the vent / filter region. Note that a smaller lumen can still wet the filter / vent with fluid 6202 if the vent / filter 6304 is upward or outward, and a larger lumen can reduce the likelihood of wetting the filter / vent.

[0295] In embodiments where the filter / vent is located at or near the junction of the Foley catheter and the drainage tube, the area under or near the filter / vent may be taped to the patient's leg to stabilize the Foley catheter once the Foley catheter is placed in a predetermined position. A larger lumen tube helps prevent wetting of the filter / vent in such situations, particularly when the vent / filter is oriented away from the leg and thus away from the patient. In some embodiments, the vent barb may be configured such that the vent / filter faces outward when the barb or barb area is taped to the patient's leg. For example, as shown in FIG. 64, the barb may be curved or attached to a curved base so as to be better attached to and oriented by the patient's leg 6402.

[0296] In some embodiments, the barb area may be elongated, for example, between about 6 inches to about 12 inches (about 15.24 cm to about 30.48 cm), such that the vent / filter can be easily positioned in a location and manner that keeps the vent / filter dry when the vent / filter is positioned further away from the patient.

[0297] In some embodiments, the vent / filter may be placed at the diameter of the drainage lumen within the barb or at multiple locations around other portions. Alternatively, the vent may surround all or most of the outer periphery of the lumen. In these embodiments, a reinforcing cuff or other structure may surround the vent to provide structural integrity to the lumen. The filter / vent may be placed along the length of the drainage tube.

[0298] The embodiment shown in FIG. 65 will also prevent wetting of the vent / filter. This embodiment includes a vent tube 6502 having an inner lumen that connects to a drainage lumen 6504 in the vicinity of the barb region 6506 and is vented to the atmosphere, or other air / gas / fluid, along the vent tube and / or via one or more filters / vents 6508 near the other end. The filter / vent may be within the urine collection container or in other locations, such as a location separate from the urine collection container, as shown in FIG. 65.

[0299] The vent lumen may run alongside the urine drainage lumen or be incorporated within the urine drainage lumen. Alternatively, the vent lumen may be connected to the drainage tube lumen separately from the drainage tube lumen, for example, at the vent tube / drainage tube junction near the barb region 6506.

[0300] The embodiment shown in FIG. 66 depicts a sensing Foley catheter system comprising a positive pressure vent tube 6602 having an inner lumen in fluid communication with a urine drainage lumen 6604 and a pump 6606. The positive pressure vent tube may include a filter 6612 anywhere along its length, in-line or otherwise. The positive pressure vent tube may include a vent at either end of the tube, at any location along the tube, or multiple vents.

[0301] Instead of pulling negative pressure on the urine drainage lumen and discharging positive pressure into the atmosphere, the pump returns positive pressure to the urine drainage lumen via a positive pressure tube. Alternatively, different pumps for negative and positive pressure may be used. In this way, accurate negative or positive pressure can be controlled at the junction 6608 between the urine drainage lumen and the positive pressure vent tube. Preferably, the pressure within the junction 6608 is slightly negative or neutral to prevent the fluid flow from flowing back into the Foley catheter. For example, the pressure within the junction may be maintained at about 0 mmHg. Alternatively, the pressure within the junction may be maintained at about -2 mmHg. Any regulator 6610 may control the negative pressure relative to the positive pressure in terms of magnitude, timing, etc. For example, the regulator (controlled by the control unit) may apply positive pressure to the positive pressure tube after a slight delay when the negative pressure is first pulled on the urine drainage line and then at a set time or when a specific negative pressure is achieved to complete the positive pressure tube / drainage tube junction. Thereby, the net pressure at the positive pressure tube / drainage tube junction becomes positive pressure, preventing urine from flowing into the bladder rather than out of the bladder. The optional regulator may be in the form of a vent of a specific size (lower surface area or denser filter material for higher resistance, larger surface area or looser filter material for lower resistance). The positive pressure vent tube may be connected to the urine drainage lumen via a valve such as an umbrella valve having a set crack pressure.

[0302] Alternatively, the positive pressure tube may be pressurized by compressed sterile fluid / gas / air.

[0303] In addition, by accurately controlling the negative pressure acting on the bladder, normal filling and emptying of the bladder may be repeated. For example, a neutral or zero pressure may be maintained so that the bladder is filled normally, or a slightly positive pressure may be maintained for a certain period of time based on the Foley base. Then, after a set time has elapsed or after a predetermined pressure (i.e., the pressure required to maintain neutral pressure at the base of the Foley catheter) has been reached, the pressure is reduced and the bladder may be emptied or drained. This process can be controlled by a control unit that controls the pressure regulator to repeat this process in order to emulate normal filling and emptying of the bladder.

[0304] In some embodiments, a valve may be used at the base of the Foley catheter to better control the pressure within that region, including the pressure (negative or positive) exerted on the bladder.

[0305] Note that embodiments of the positive pressure tube may be used in combination with any of the embodiments of the sensing Foley catheter system, including those having a filter / vent structure different from that shown herein. In addition, any of the embodiments of the anti-airlock may be used in combination with a normal, i.e., non-sensing, Foley catheter, or other catheter or drainage tube.

[0306] Figures 67 through 86 are enlarged views showing the barb region X of FIG. 66 to illustrate examples of different embodiments of this region.

[0307] In the embodiment shown in FIG. 67, a valve 6702 such as an umbrella valve having a set crack pressure is shown between the lumen of the positive pressure vent tube 6602 and the urine drainage lumen 6604. The valve may be a one-way valve. A vent 6704 is shown between the positive pressure vent tube and the atmosphere. Also, there is a configuration in which only a vent or only a valve exists. The opening 6706 is in fluid communication with the urine drainage lumen 6604 and the chamber 6714 (the valve 6702 periodically interrupts fluid communication to the chamber). The chamber 6714 is in fluid communication with the lumen of the positive pressure vent tube 6602. Periodically or continuously, positive pressure is applied via the positive pressure lumen 6602 and / or negative pressure is applied to the urine drainage lumen 6604. When the crack pressure of the valve 6702 is exceeded, fluid, preferably gas, flows through the valve 6702, through the opening 6706, and through the lumen of the urine drainage lumen 6604. This serves both to purge an air lock or any blocked line and to purge any fluid in the chamber 6714, thereby reducing the likelihood that the vent 6704 will become wet. Also, if it is wet, it helps to clean the vent 6704. The crack pressure of the valve 6702 is the differential pressure between the positive pressure lumen 6602 and the urine drainage lumen 6604. When the pressure in the urine drainage lumen is below the pressure in the positive pressure lumen by the crack pressure, the valve opens, allowing fluid to flow from the positive pressure lumen through the chamber, through the opening 6706, and through the drainage lumen. For example, the crack pressure may be less than about 1 mmHg. Alternatively, the crack pressure may be less than about 2 mmHg. Alternatively, the crack pressure may be less than about 3 mmHg. Alternatively, the crack pressure may be less than about 4 mmHg. Alternatively, the crack pressure may be less than about 5 mmHg. Alternatively, the crack pressure may be less than about 10 mmHg.

[0308] The pressure within the urine drainage lumen may be approximately -5 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -7 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -10 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -15 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -20 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -25 mmHg, either periodically or continuously. Alternatively, the pressure within the urine drainage lumen may be approximately -30 mmHg, either periodically or continuously.

[0309] The positive pressure within the positive pressure lumen may be approximately 5 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 7 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 10 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 15 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 20 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 25 mmHg, either periodically or continuously. Alternatively, the positive pressure within the positive pressure lumen may be approximately 30 mmHg, either periodically or continuously.

[0310] The vent may further or alternatively be present at other locations along the positive pressure vent tube, such as near the pump or as part of the pressure regulator. A second vent / valve assembly 6708 is shown in the valve of FIG. 67, but this second vent / valve assembly may or may not be present. Optional thermistor 6710 and optional pressure lumen 6712 are also shown. The positive pressure vent tube may alternatively be exposed to atmospheric pressure. A valve or additional valve may be present anywhere within the system, including within the positive pressure tube 6602 or within the reservoir.

[0311] Figure 68 shows a barb region including a vent 6802, a valve 6804, and a small cross-sectional area region 6806. The cross-sectional area region is large enough to allow free flow of air / gas from the vent to the urine drainage lumen, but small enough to prevent liquid flow into the vent. For example, the constriction 6806 may have a diameter of less than about 1 mm. Alternatively, the constriction may have a diameter of less than about 2 mm. Alternatively, the constriction may have a diameter of less than about 3 mm. Alternatively, the constriction may have a diameter of less than about 4 mm. The length of the constriction may be about 1 to 5 mm. Alternatively, the length of the constriction may be about 5 mm to 30 mm. The embodiment shown in Figure 68 may or may not include a positive pressure tube, but the drawing is shown without a positive pressure tube (i.e., exposed to the atmosphere). This embodiment may or may not include a valve. This embodiment and any embodiment may be incorporated into the barb, or may be separate components that can be added to the barb (via a sampling or other port) or elsewhere in the system (e.g., along the drainage tube, preferably in the 1 / 3 portion of the drainage tube closest to the patient).

[0312] Figure 69 is a diagram showing a barb region according to an embodiment including a vent 6902 and a vent tube 6904 of sufficient length to allow free flow of air / gas from the vent to the urine drainage lumen, but to prevent liquid flow into the vent. For example, the vent tube portion 6904 may have a diameter of about 1 to 10 mm and a length of about 1 to 10 cm. For example, the length of the vent tube portion 6904 may exceed about 2 cm. Alternatively, the length of the vent tube portion 6904 may exceed about 4 cm. Alternatively, the length of the vent tube portion 6904 may exceed about 10 cm. The embodiment shown in Figure 69 may or may not include a positive pressure tube, but here it is shown without a positive pressure tube. This embodiment may or may not include a valve.

[0313] Figure 70 shows a barb region according to an embodiment that includes a vent 7002 and an elongated serpentine vent tube 7004 that allows free flow of air / gas from the vent to the urine drainage lumen but is sufficiently serpentine to prevent liquid flow into the vent. For example, the vent tube portion 7004 may be a coil. The embodiment shown in Figure 70 may or may not include a positive pressure tube, but is shown here without a positive pressure tube. This embodiment may or may not include a valve.

[0314] Figure 71 shows a barb region according to an embodiment that includes a vent 7102 and a small serpentine vent tube 7104 that allows free flow of air / gas from the vent to the urine drainage lumen but is sufficiently serpentine to prevent liquid flow into the vent. For example, the vent tube portion 7104 may be a tube having a baffle or mesh in the inner lumen. The embodiment shown in Figure 71 may or may not include a positive pressure tube, but is shown here without a positive pressure tube. This embodiment may or may not include a valve.

[0315] FIG. 72 is a diagram showing a barb region according to an embodiment including a vent 7202 and a vent tube 7204. In this embodiment, the vent tube is in fluid communication with a positive pressure tube 7206, and the vent 7202 is aligned with the positive pressure lumen such that fluid under positive pressure enters the drainage lumen through the opening 7208 through / across the vent. Here, the vent tube 7204 is shown coiled to assist in preventing backflow of urine into the vent tube, but the vent tube 7204 may be of any configuration including a straight tube or a lumen incorporated into the barb region. The vent 7202 is shown here near the junction of the vent tube 7204 and the positive pressure tube 7206, but the vent may be provided anywhere along the positive pressure lumen including near the pump / cassette or along the positive pressure lumen including near the opening to the drainage lumen 7208. This embodiment may or may not include a valve.

[0316] FIGS. 73A and 73B are diagrams showing a barb region according to an embodiment including a vent 7302 and a small vent tube 7304 having a serpentine shape sufficient to allow free flow of air / gas from the vent to the urine drainage lumen but to impede flow of liquid to the vent. Additionally, the vent end of the vent tube 7304 may be configurable, bendable, or deformable such that it can be oriented upward after the barb region is secured to the patient's leg. By orienting the vent end of the vent tube upward, the chance of the vent being exposed to liquid is reduced. For example, the vent tube portion 7304 may be a substantially flattened coil. The embodiment shown in FIG. 73 may or may not include a positive pressure tube, but is shown here without a positive pressure tube. This embodiment may or may not include a valve 7306.

[0317] Figure 74 is a diagram showing a valve region according to an embodiment including a plurality of vents 7402 and optional valves 7404. By providing a plurality of vents, the possibility that all vents get wet with urine is reduced. The plurality of vents may be in any suitable configuration including lines, circles, etc. The plurality of vents may be on one side of the valve or may partially or completely surround the valve. For example, two vents may be included, three vents may be included, four vents may be included, five vents may be included, six vents may be included, seven vents may be included, eight vents may be included, nine vents may be included, or ten vents may be included. The embodiment shown in Figure 74 may or may not include a positive pressure tube, but is shown without a positive pressure tube in the drawing. In this embodiment, a valve may or may not be included.

[0318] Figure 75A is a diagram showing a valve region according to an embodiment that may still include one or more vents but does not rely on vents. In this embodiment, the positive pressure tube 7502 is in fluid communication with the urine drainage lumen via the opening 7504. Additionally, a valve, preferably a pressure-sensitive valve 7506, is between the opening 7504 and the drainage catheter and is in fluid communication with a positive pressure source via the opening 7510. The valve 7506 is depicted in Figure 75A as an inflatable valve such as an annular balloon (also shown in Figure 75B). The valve 7506 may be inflated via the same pressure source connected to the positive pressure tube 7502 or via an individual pressure source. The valve 7506 may be in fluid communication with the lumen of the positive pressure tube 7502 as shown here or may be inflated via an individual positive pressure lumen.

[0319] In this embodiment, when positive pressure is periodically applied to the drainage lumen via the positive pressure tube 7502, the valve 7506 closes. The closing of the valve prevents air or positive pressure from reaching the bladder and purges the drainage lumen with the fluid (gas or liquid) pressurized by the positive pressure. When the positive pressure in the positive pressure tube is reduced, the valve opens and urine is discharged from the bladder again. A slight positive pressure may be maintained in the positive pressure tube to counteract the negative pressure in the urine drainage line. If a higher pressure is required to eliminate the air lock line, the valve 7506 is closed during the flushing with the higher pressure.

[0320] FIG. 76 shows an embodiment similar to that shown in FIG. 75, but in this embodiment, the valve 7602 is a passive mechanical valve. The valve 7602 is normally in a flat position, i.e., an open position. When the positive pressure in the positive pressure tube is higher than any negative pressure in the drainage lumen, the valve automatically closes to prevent the fluid / positive pressure from being transmitted to the patient's Foley catheter / bladder.

[0321] Alternatively, a Venturi may be used to control the negative and positive pressures leaking into the valve area, similar to that of an automobile carburetor.

[0322] FIGS. 77A and 77B show another embodiment using a more active valve system. This embodiment includes a suction chamber 7702, an adapter portion 7704, a patient side valve 7706, a drainage side valve 7708, a drainage lumen inlet 7710, and pressure lines 7712, 7714, 7716, 7718.

[0323] In the passive position, i.e., the open position, both the patient-side valve 7706 and the drainage-side valve 7708 are open. That is, since the balloon / bladder is not inflated, urine can pass freely from the drainage catheter 7722, through the drainage lumen 7720 of the barb, and through the drainage tube 7724. In the open position, the conforming portion 7704 is in the neutral position. When an occlusion event such as an air lock occurs, or periodically to prevent occlusion, pressure is applied, such as a pressurized fluid (gas or liquid) via the pressure line 7716, to close the drainage-side valve 7708. The conforming portion 7704 expands by applying a negative pressure via the pressure line 7718. The pressure line 7714 remains neutral or closed. The pressure line 7712 maintains a neutral, closed, or negative state to fully retract the valve 7706. In this configuration, the flow of fluid to the drainage line 7724 can be blocked while expanding the conforming portion 7704 to effectively apply a negative pressure to the drainage catheter. This structure is shown in FIG. 77A.

[0324] In the configuration of FIG. 77A, for example, it lasts only for a short time of about 0.5 to 1 second, or about 1 to 3 seconds, or about 3 to 5 seconds. The patient-side valve 7706 is closed by applying a positive pressure to the pressure line 7712, and the drainage-side valve is opened by reducing the pressure in the pressure line 7716 to neutral or applying a negative pressure to the pressure line 7716. The volume of the fitting portion 7704 is reduced by raising the pressure in the pressure line 7718 to neutral or applying a positive pressure to the pressure line 7718. A positive pressure may also be applied to the pressure line 7714. This structure is shown in FIG. 77B. In this configuration, the fluid in the drain lumen 7720 and the drainage line 7724 is flushed by the positive pressure applied via the pressure line 7714 and / or by the reduction in the volume of the fitting portion 7704, and the urine can be effectively flushed through the drainage line. After the flushing, the system is returned to the neutral position where both the patient-side valve 7706 and the drainage-side valve 7708 are open and the fitting portion 7704 is in the neutral position.

[0325] Figure 78 shows an embodiment similar to that shown in Figure 72, but includes a positive pressure vent tube 7802 instead of individual vent tubes. The vent 7804 is in fluid communication with and juxtaposed to the lumen of the positive pressure vent tube 7802. The vent 7804 is also in fluid communication with the barb region of the urine drainage lumen 7808 and is connected to the region 7808 by an opening 7806. Fluid / air / gas under positive pressure traverses the vent 7804 and passes through the opening 7806 into the region 7808 that is in fluid communication with the drainage lumen. That is, positive pressure fluid / air / gas passes across the filter and into the interior of the barb. Wetting of the vent 7804 is prevented by controlling the positive pressure within the positive pressure tube, the positive pressure across the vent 7804, and the negative pressure of the drainage lumen. In some embodiments, the pressure within the barb region of the urine drainage lumen 7808 is near about zero. The vent 7804 may be located at any point along the length of the positive pressure vent tube 7802. The embodiment shown in Figure 78 may or may not include a one-way valve between the filter and the opening. Positive pressure fluid / air / gas may pass through the vent continuously, intermittently, sporadically, etc. Positive pressure fluid / air / gas may pass through the vent as a flow or as puffs or pulses.

[0326] Filters throughout the system can be cleaned using pressure, whether they are located in the barb, positive pressure tube, vent tube, reservoir, or elsewhere. For example, puffs of pressurized air or gas may be used to clean the filter if it is wet or passed across the filter to prevent it from getting wet. Alternatively, a steady or intermittent flow of air or gas may be used.

[0327] Figure 79 shows an embodiment in which the region within the barb that is in fluid communication with the urine drainage lumen has a larger volume. Fluid 7902, such as urine, flows from the drainage catheter into the large reservoir 7904 and then into the urine drainage lumen. The reservoir 7904 is sized such that it is unlikely to be completely filled with liquid. The volume of the reservoir that is not filled with liquid will be filled with air or gas. A one-way valve 7908 may also be present. Since the reservoir 7904 will always have some air / gas within it, the vent 7906 may be positioned such that it rarely contacts the urine / fluid within the reservoir. That is, the vent may be on the side of the air bubbles within the reservoir. Two or more vents may be provided such that at least one vent is always in fluid communication with the gas bubbles within the reservoir. In some embodiments, the volume of the reservoir 7904 may be larger than the volume of the lumen of the drainage tube.

[0328] Figures 80A and 80B show an embodiment in which the vent area is very large. The vent 8002 is shown here as a large flat circle or disk, but the vent may be of any shape and size. The vent may be flat or may be curved so as to wrap around the barb region. In the embodiment shown here, one opening 8004 and a one-way valve 8006 are shown, but in other embodiments, there may be two or more openings, and there may or may not be a valve. In some embodiments, the filter surface may have an area greater than about 1 cm 2 . In some embodiments, the filter surface may have an area greater than about 2 cm 2 . In some embodiments, the filter surface is about 3 to about 4 cm 2 . Alternatively, in some embodiments, the filter surface is about 2 to about 4 cm 2 . Alternatively, in some embodiments, the filter surface is about 4 to about 6 cm 2 . Alternatively, in some embodiments, the filter surface is about 6 to about 10 cm 2 .

[0329] FIG. 81 is a diagram showing an embodiment having an exchangeable vent. The exchangeable vent 8102 is shown here in one embodiment having a positive pressure tube 8104 and a one-way valve 8106, but there may also be embodiments that do not have at least one of the positive pressure tube and the valve. The exchangeable vent 8102 may be removed and replaced via an attachment mechanism such as a luer lock, snap lock, slide-in lock, press fit, or any other suitable mechanism. The vent may be exchanged periodically, such as once a day, or as needed, for example, when the control unit warns the user that the vent no longer functions properly, or when the user notices that the vent has not functioned for a long time. The vent may contain urine-sensitive chemicals or urine components, and the components may indicate that they are wet by changing color. For example, pH-sensitive paper, or other chemical or attribute-sensitive paper, may be used for an exchangeable vent that changes color to be visible to the user. The exchangeable vent may be disposable.

[0330] Figures 82A and 82B are diagrams showing an embodiment in which the filter has flexibility. In this embodiment, the filter 8202 may be flexible or deformable, i.e., it may be convex / concave or loose within its housing, and the movement of the flexible filter 8202 may assist in removing filter clogging when the filter is wet or contaminated. The movement of the filter may be controlled by positive pressure via the positive pressure tube 8204, negative pressure via the urine drainage lumen, negative pressure via the valve 8206, or any single or combination thereof. In some embodiments, a mechanical mechanism for agitating, shaking, vibrating, bending, and / or moving the filter 8202 may be further included. Figure 82A shows, for example, an example of an embodiment in which the filter is recessed by negative pressure within the urine drainage lumen. Figure 82B is a diagram showing a similar example after positive pressure is applied to the vent via the positive pressure tube 8204. The pressure within the vent housing 8208 may be controlled by the cracking pressure of a one-way valve or by the relative negative pressure and relative positive pressure within the urine drainage lumen and within the positive pressure tube. In similar embodiments, there may be cases where the filter is not flexible, but the pressure is controlled within the vent housing 8208 in a similar manner to keep the filter in a dry state.

[0331] Alternatively, the filter (flexible or otherwise) may be mechanically wiped or rubbed, either manually or automatically. Alternatively, the filter may include a chemical substance, such as an enzyme detergent, that suppresses protein adhesion and / or accumulation. Alternatively, the filter may include an agent that suppresses biofilms, such as an antibacterial agent.

[0332] FIG. 83 is a diagram showing an embodiment having a plurality of laminated filters. Filters with different pore sizes may be laminated and used. For example, the coarse pore filter 8304 may protect the fine pore filter 8302 from getting wet. The coarse pore filter 8304 may be disposed between the fluid / urine and the pore filter 8302. In this configuration, the liquid / urine needs to pass through the coarse filter 8304 in order to contact the fine filter 8302. In this way, three or more filters can be stacked, and any of the pore sizes with graduations, or similar pore sizes, or any pore size can be used. For example, as the pore filters are miniaturized, the pore filters may be laminated so as to be further away from the urine / liquid. Alternatively, one or more coarse pore filters of the same or different pore sizes may be disposed between the urine / liquid and the pore filter. There may or may not be a one-way valve. The pore size of the coarse pore filter 8304 may be about 10 micrometers. Alternatively, the pore size of the coarse pore filter 8304 may be about 10 to about 20 micrometers. Alternatively, the pore size of the coarse pore filter 8304 may be about 10 to about 30 micrometers.

[0333] FIG. 84 is a diagram showing an embodiment in which a positive pressure is continuously applied to a valve region by a fluid in a positive pressure tube 8402. The positive pressure tube is under a substantially constant positive pressure such that a fluid (preferably air / gas) continuously passes through the opening 8404. The positive pressure applied to the fluid inside 8406 of the valve is controlled so that the fluid does not flow back into the urine drainage catheter. That is, the negative pressure applied to the fluid inside 8406 is always greater than or substantially the same as the positive pressure applied to the fluid inside 8406. The positive pressure may be controlled by a control unit and / or may be controlled by the size of the opening 8404, for example, by making the opening 8404 very small. For example, the diameter of the opening 8404 may be less than about 1 mm. Alternatively, the diameter of the opening 8404 may be less than about 2 mm. Alternatively, the diameter of the opening 8404 may be less than about 3 mm. Alternatively, the diameter of the opening 8404 may be less than about 4 mm.

[0334] FIG. 85 is a diagram showing an embodiment having an accordion-shaped vent. The vent 8502 of this embodiment has a shape like an accordion. The vent may be compressed in the direction of the double-headed arrow. This compression can remove clogging / wetting of the vent. The compression may be performed manually, automatically / machine, and / or using the pressure (at least one of negative and positive) in the vent region.

[0335] FIG. 86 is a diagram showing an embodiment having a single vent and a plurality of openings. In this embodiment, two or more small openings 8602 separate the urine drainage lumen from the vent 8604. The small openings prevent the fluid from contacting the vent 8604. Since the plurality of openings may function as redundancy, even if one or more openings are clogged, the other openings remain open. The openings may also be used to control the passage of air / gas / fluid through the vent 8604 - the more holes there are, the less resistance to the air flow, and the fewer holes there are, the higher the resistance to the air flow.

[0336] Any of the embodiments of this specification may include physiological pressure measurement values or may be used without including physiological pressure measurement values. For example, the systems shown in FIGS. 67 to 86 and other embodiments do not include a thermistor or a pressure lumen and can be used in combination with a standard Foley catheter.

[0337] In some embodiments, the pressure may be measured at the positive pressure tube / drain tube junction. Alternatively, the pressure may be measured at the sensing Foley catheter / drainage tube junction or in the area of the valve. The pressure may be measured at any of these locations by incorporating an additional tube or lumen that is in fluid communication with the pressure tube / drainage tube junction or has one end in fluid communication with the area of the valve and the other end in fluid communication with a pressure sensor or transducer. For example, this pressure measurement lumen may be in fluid communication with a control unit that houses a pressure sensor at one end (sensor side) and in fluid communication with the positive pressure tube / drainage tube junction at the other end (detection side). A pressure-sensitive membrane may be present at the detection end to prevent urine contamination of the lumen.

[0338] Also, air locks may be detected such that they are optimally resolved and / or avoided. Using any of the embodiments of this specification, the control unit may apply a slight positive or negative pressure to the urine drainage lumen and detect its response. Since air is more compressible than urine, a damped response can indicate the presence of an air lock, and an undamped response can indicate the absence of an air lock. If an excessive air lock is detected, the control unit may initiate the resolution of the air lock, for example, by applying a negative pressure to the drainage lumen.

[0339] In some embodiments, the valve can be present anywhere within the system including within the positive pressure tube or the reservoir.

[0340] The vent tube may be a tube separate from the drainage tube and may be inserted into the drainage lumen or into the Foley catheter. FIG. 87 is a diagram showing a detection Foley catheter system according to an embodiment in which the vent tube is within the urine drainage tube. Embodiments of this type have the advantage that any standard drainage tube can be used. The vent tube basically places a vent either within the drainage tube or within the Foley catheter at any location within the drainage lumen. The vent tube may be slidably inserted within at least one of the drainage tube and the Foley catheter and is movable at any time.

[0341] In the embodiment shown in FIG. 87, the vent tube 8704 may be open at one end ("air end" 8708) to a vent / filter 8702 (open to atmospheric pressure) within the urine reservoir and at the other end ("urine end" 8710) to be within the urine drainage lumen 8706. Here, the vent tube is shown as terminating within the barb at the base of the Foley catheter, but the vent tube may terminate at any location within the urine drainage lumen, including any location within the drainage tube or any location within the Foley catheter. The vent tube may remain in one place or may be moved within the system to maximize urine drainage and minimize air lock due to negative pressure within the bladder and bladder damage.

[0342] Figure 88 shows a sensing Foley catheter system according to another embodiment, where the vent tube 8802 has a vent / filter 8804 at the "urine end" of the tube and is open to the atmosphere at the "air end" 8806 of the tube. Also, filters / vents may be provided at both ends. The "air end" of the vent tube may exit the drainage lumen via a Y-arm adapter, stopcock, or other standard means. The "air end" of the vent tube may exit the system from within the urine collection container via a channel or port incorporated into the urine collection container. Again, the vent tube can be used in combination with any urine drainage tube, including standard urine drainage tubes.

[0343] Figure 89 shows an embodiment similar to the embodiment shown in Figure 88 with the addition of a positive pressure tube 8902.

[0344] Figures 90, 91A, and 91B show the vent tube at different positions within the sensing Foley catheter system. In Figure 90, the "urine end" 9002 of the vent tube passes through only a portion within the drainage tube. For example, the vent tube may be inserted through approximately half of the drainage tube. Alternatively, for example, the vent tube may be inserted through approximately one-third of the drainage tube. Alternatively, for example, the vent tube may be inserted through approximately two-thirds of the drainage tube. In Figure 91A, the "urine end" 9002 of the vent tube is within the Foley catheter. The position of the "urine end" of the vent tube is determined based on maximizing urine drainage, minimizing the effect of an air lock on urine drainage, and minimizing negative pressure within the bladder. In Figure 91B, the vent tube is inside the drainage tube, with one end connected at or near a barb and terminating near 6 to 24 inches (about 15.24 cm to about 60.96 cm) below the drainage line. The vent tube may or may not include a filter or valve.

[0345] In some embodiments, the vent tube is attached to the detection Foley catheter system after an initial amount of urine has been drained from the bladder.

[0346] The vent tube may incorporate one or more filters / vents. The vent tube may incorporate one or more notches that are in fluid communication with the inner lumen of the vent tube and ultimately in fluid communication with the vent / filter within the urine reservoir or elsewhere. Multiple filters / vents or multiple notches may be around the vent tube, along the vent tube, or both. The vent tube may include ultraviolet light directed towards the filter, the "urine end", or elsewhere to maintain sterility.

[0347] Figures 91C and 91D are diagrams showing other embodiments where the vent tube is concentric with the urine drainage lumen. The embodiment shown in Figure 91C may be similar to the vent and drainage tubes shown in Figure 87, with the vent tube 8704 within the drainage lumen 8706. The embodiment shown in Figure 91D shows one embodiment where the drainage lumen 8706 is within the vent lumen 8704. The vent lumen in any of the embodiments disclosed herein may extend along part or all of the length of the drainage lumen.

[0348] The various lumens of the system may be coupled to one or more tubular extrusions. Also, the tubes may be separate, or two or more tubes may be attached to each other to prevent kinking. For example, four tubes may be attached to each other along a substantial portion of their length, including lumens for drainage, ventilation, temperature, and pressure measurement. Alternatively, five tubes may be connected. Tubes may be included to increase rigidity. The lumen of the tube may include a reinforcing wire or mandrel to increase rigidity. The tubes may be co-extruded, extruded individually, or connected later along their length. The lumens may be connected along all or part of their length. For example, a urine drainage tube, and optionally a vent tube, may be separated from the temperature and pressure tubes at one or more points along the length of the drainage tube. This allows the urine drainage tube (optionally together with the vent tube) to be clamped in a closed state without affecting the temperature and pressure functions of the system.

[0349] Figures 92A and 92B are diagrams showing some possible embodiments of a drainage lumen, such as the drainage lumen 1012 shown in Figure 10A. Figure 92A is a diagram showing a drainage lumen having a foldable / expandable portion 9202. The portion 9202 may be made of a lower durometer material than the rest of the drainage lumen, thereby allowing it to fold or expand in response to internal pressure. The lumen will fold to a lower internal area / volume at low or negative pressure and expand at higher or positive pressure. The airlock is reduced by such changes in lumen volume at different pressures. This type of lumen may be incorporated into any of the embodiments herein.

[0350] FIG. 92B is a diagram showing a drainage lumen including two lumens according to an embodiment. The inner lumen shown here is the negative pressure / urine drainage lumen 9204. The outer lumen is the positive pressure lumen 9206. An opening 9208 is provided between the two lumens. The opening may or may not include a filter membrane. The two lumens may be concentric or adjacent as shown here. The positive pressure lumen serves essentially the same role as the positive pressure vent tube shown elsewhere in this specification. When negative pressure is applied to the drainage lumen 9204 constantly or periodically, positive pressure is applied to the positive pressure lumen 9206, and as a result, the drainage lumen 9204 is cleaned.

[0351] FIGS. 93A through 93E are diagrams showing a drainage lumen according to another example. This embodiment also includes a drainage lumen 9302 and a positive pressure lumen 9304. In this embodiment, the positive pressure lumen 9304 is expandable and foldable. In the expanded state of the positive pressure lumen, the drainage lumen is partially or completely blocked. In the folded state of the positive pressure lumen, the drainage lumen is substantially open, and thus, fluid can flow freely through the drainage lumen. FIG. 93A is a diagram showing the blocked drainage lumen near the patient side of the drainage tube. FIG. 93B is a diagram showing the state where the blocked drainage lumen is further away from the patient. FIG. 93C is a diagram showing the open drainage lumen.

[0352] Figure 93D is a longitudinal view showing the drainage tube in the closed state. Figure 93E is a longitudinal view showing the drainage tube in the open state. In the open state, as shown in Figures 93C and 93E, the positive pressure lumen 9304 is in a folded state and does not substantially block the drainage lumen 9302, whereby urine can freely flow from the body to the reservoir. When relieving blockage such as an air lock in the drainage tube, the positive pressure lumen is inflated and flushed so as to lower the drainage tube toward the urine / liquid collection reservoir. The patient-side end 9306 of the positive pressure lumen may have a larger diameter and / or a lower durometer than the reservoir-side end 9308 of the positive pressure lumen. Thereby, the patient-side end of the positive pressure lumen can be inflated before the reservoir-side end expands. In this way, the drainage lumen is first blocked at the location closest to the patient, and then substantially all or part of the drainage lumen is filled by the expansion of the remaining part of the positive pressure lumen. The positive pressure lumen may be inflated at either the patient-side end or the reservoir-side end of the drainage tube. One or more filters may be present along the length of the drainage lumen.

[0353] Embodiments of the sensing Foley catheter system may include the ability to measure the pressure within the bladder via a pressure balloon connected to the Foley catheter or via a pressure balloon or other pressure sensor inserted within the drainage lumen of the drain tube and / or the Foley catheter. For example, refer to Figures 94A through 94C.

[0354] Figures 94A through 94C are diagrams showing embodiments of a sensing Foley catheter system where the pressure sensor is in fluid communication with the urine lumen of a Foley catheter and may be present on an individual catheter. The Foley catheter 9402 is shown with a urine lumen 9404 and a urine drainage opening 9406. A small pressure sensing catheter 9408 having a pressure sensing balloon 9410 is shown within the urine drainage lumen of the Foley catheter. The outer diameter of the pressure sensing catheter is small enough to fit within the urine drainage lumen of the Foley catheter. For example, the outer diameter of the pressure sensing catheter may be less than about 4 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 3 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 2 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 1 mm.

[0355] The pressure sensor on the pressure sensing catheter may be near the distal end of the pressure sensing catheter or at any location along the length of the catheter. The pressure sensor may be a pressure sensing balloon or any type of pressure sensor such as a piezoelectric sensor, a mechanical sensor, etc. In the case of a pressure sensing balloon, the inflated balloon may be smaller than the inner diameter of the urine drainage lumen of the Foley catheter or the inflated balloon may be large enough to fill the urine drainage lumen of the Foley catheter.

[0356] The inflated pressure sensing balloon can fill the urine drainage lumen of the Foley catheter, thereby enabling better pressure measurement. The pressure sensing balloon may contract periodically or partially contract so that urine can flow from the bladder through the Foley catheter. The control of the inflation cycle of the pressure sensing balloon may be controlled by the control unit of the present invention.

[0357] FIG. 94B is a diagram showing a pressure sensing catheter according to an embodiment having both an occlusion balloon 9424 and a pressure sensing balloon 9426. Since the occlusion balloon occludes the urine drainage lumen, the pressure sensing catheter will only sense the pressure between the occlusion balloon and the bladder, thereby enabling a more accurate measurement of the pressure within the bladder.

[0358] The outer diameter of the inflated pressure sensing balloon may be less than about 5 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 4 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 3 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 2 mm, alternatively, the outer diameter of the pressure sensing catheter may be less than about 1 mm.

[0359] FIG. 94C is a diagram showing a standard Foley-type catheter having a retention balloon 9412, a urine drainage opening 9406, a retention balloon port 9414, and a urine drainage port 9416. Adapter 9418 is shown connected to urine drainage port 9416. Adapter 9418 has two ports, a urine drainage port 9420 and a second urine lumen port 9422. Pressure sensing catheter 9408 is shown within urine lumen port 9422. In this way, the pressure sensing catheter is in fluid communication with the urine drainage lumen of the Foley-type catheter. The proximal end of pressure sensing catheter 9408 is connected to a pressure sensor, such as a pressure transducer, as in other embodiments herein. Pressure sensing catheter 9408 may have only a single lumen, which is the sensing balloon lumen, or may include a plurality of other lumens. Also, if the pressure sensor of the pressure sensing catheter is a mechanical pressure sensor, the pressure sensing catheter may have no lumen, or a balloon may be provided in the pressure sensing catheter to seal the urine drainage lumen of the Foley-type catheter.

[0360] Also, the pressure sensing catheter may be inserted from the urine drainage lumen of the drainage tube.

[0361] Pressure measurements are taken over time using a pressure sensing catheter and can be analyzed by any of the methods disclosed herein. To improve pressure measurements, the drainage port 9420 may be periodically closed or occluded. Occlusion of the drainage port 9420 may be done mechanically, using a stopcock or valve, or automatically, for example using a solenoid valve connected to a control unit. An advantage of this embodiment is that the pressure sensing catheter 9408 can be used in combination with any Foley-type catheter for measuring pressure. Additionally, the pressure sensing catheter 9408 can be inserted or removed after the Foley-type catheter has already been placed within the patient's bladder.

[0362] The pressure sensing catheter may be combined with the vent tube shown in other figures. In this way, the pressure sensing, urine drainage, anti-airlock, vent components of the sensing Foley catheter system can be used in combination with any standard Foley catheter and drainage tube. Alternatively, the pressure sensing catheter / vent tube combination may be used in combination with more specialized Foley catheters and / or drainage tubes.

[0363] In any of the embodiments including any type of airlock elimination mechanism, the airlock elimination may be performed continuously, periodically (at regular intervals or at any time), in response to a request, or when an airlock state is detected. The airlock elimination mechanism prevents or reduces an airlock. For example, the airlock elimination mechanism may reduce the airlock such that the airlock is eliminated 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.

[0364] In any of the embodiments including a vent or a filter or a vent tube as part of a barb region or a drainage tube, the drainage of fluid (i.e., urine) may be discontinuous, i.e., interrupted, due to gas / air introduced into the drainage lumen via the vent / filter / vent tube. That is, the drainage lumen may alternately contain liquid (i.e., urine) and gas.

[0365] In any of the embodiments including measuring the urine output in real time, real time may mean that the reported urine output measurement is accurate within approximately 1 minute. Alternatively, real time may mean that the reported urine output measurement is accurate within approximately 5 minutes. Alternatively, real time may mean that the reported urine output measurement is accurate within approximately 10 minutes. Alternatively, real time may mean that the reported urine output measurement is accurate within approximately 20 minutes. Alternatively, real time may mean that the reported urine output measurement is accurate within approximately 30 minutes. Alternatively, real time may mean that the reported urine output measurement is accurate within approximately 60 minutes.

[0366] Bubbles in urine - Preventing the generation of bubbles and / or preventing the influence on measurement values

[0367] In some cases, proteins or other components in urine may cause excessive bubbles in the urine in the drainage lumen and / or the urine collection container, which may cause problems such as wetting of the vent / one or more filters, intrusion of urine into the overflow area of the urine collection container, and inaccurate measurement. In some embodiments of the detection Foley catheter system, an anti-bubble mechanism is incorporated.

[0368] In some embodiments, such as those incorporating a positive pressure tube, accurate control of the pressure in urine drainage can be obtained. In order to collapse existing bubbles or prevent the formation of bubbles, a slight positive pressure can be intermittently applied to the drainage system (i.e., the drainage lumen and / or the urine collection chamber).

[0369] A surfactant, such as silicone, simethicone, or other suitable material, may be added to the system. For example, slowly dissolving silicone capsules may be added to the urine reservoir. Alternatively, a surfactant coating may be used on at least one of the inner side of the drainage lumen and the inner side of the urine collection container.

[0370] Bubbles may be removed or reduced at the junction of the drainage tube and the urine collection container. Some embodiments are shown in FIGS. 95A through 95C. For example, the base of the drainage tube may be in an S-drain shape (such as a drain pipe under a sink), the inner diameter of the drainage tube may expand near the junction with the urine collection container, or may expand elsewhere. The drainage tube may be spherical or conical. As shown in FIG. 95C, the drain lumen may be annular. In this embodiment, in order to reduce the bubbles in the beer, in the same way that the beer is poured onto the side of the glass rather than the center of the glass, in order to reduce the bubbles, the fluid is forced to flow onto the side of the inclined conical surface. Here, the bubble reducing element is shown at the base of the drainage tube, but may be at any part of the drainage tube or at any part of the system. In some embodiments, the drain lumen may be flattened to force the urine to contact the surface again. For example, the urine drainage lumen may be flattened to less than about 1 mm. The urine drainage lumen may be flattened to less than about 2 mm. The urine drainage lumen may be flattened to less than about 3 mm.

[0371] Also, the urine may be forced to flow to a single point as shown in the inverted cone embodiment of FIG. 96A. The cone may have an angle as shown here, or may be more curved. The conical shape generally transitions from a small area to a large area and / or from a large area to a small area. Also, such a bubble reducing mechanism and other bubble reducing mechanisms may be within the urine collection container. For example, as shown in FIGS. 96B through 96D, angled baffles may be incorporated into the urine reservoir to force the fluid to flow downward onto the angled surface. The angled surface may extend entirely to the bottom of the urine collection container or may extend only partially into the urine collection container. Different angles may be used, for example, angles up to about 10 degrees to about 80 degrees may be used.

[0372] Angled baffles, as shown by the embodiments of FIGS. 96C and 96D, may also be preferred under the conditions of critically ill patients, especially when the patient's urine output is low and continuous measurement of urine output (ml / min or ml / sec) is desired to diagnose the patient's vulnerability to the onset of AKI, sepsis, or other conditions, in order to improve the accuracy of urine volume measurement. To accurately measure a small amount of urine volume, since the height of the urine column is greater than that of a flat-bottomed baffle or cassette for a given urine volume, it is possible to make a more accurate measurement by using a conical or angled baffle. The ultrasonic transducer or a similar transducer on the control unit can more reliably measure the height and can accurately measure the urine volume and urine output rate, especially when the patient's kidneys are damaged and produce little urine. In addition, the angled / baffled or cassette (urine collection chamber) has lower sensitivity to changes in the tilt angle of the control unit compared to a cassette with a flat surface in the case of a small amount of urine volume, and can reduce measurement errors.

[0373] FIG. 97A is a diagram showing a detection Foley catheter system according to an embodiment in which a drainage lumen extends into a urine collection container / cassette such that fluid is discharged into the fluid generally collected below the fluid level. The drainage end of the drainage lumen 9722 may be cut at an angle so that the tube does not adjoin the bottom of the cassette that may impede the flow of fluid. The angled cut 9724 may be about 45 degrees, about 10 to 80 degrees, or any suitable angle. Other shapes may be used at the drainage end of the drainage lumen to obtain the same result. For example, FIG. 97B shows a drainage lumen, and the tube of this drainage lumen is splined at the drainage end. The shape of the splined portion 9726 may be any shape including a rounded shape, a rectangular shape, a triangular shape, a scallop shape, etc.

[0374] FIG. 97C is a diagram showing a sensing Foley catheter system according to an embodiment, in which a drainage lumen extends into the cassette and includes a flattened region 9728. In this embodiment, the cross-sectional area of the drainage lumen may remain the same, increase or decrease in the flattened region, but preferably at least one dimension is increased so that the fluid flow comes into forced contact with the increased surface area. As shown in FIG. 97C, the flattened region may be oriented downwardly in the flow, or the flattened portion may be angled to contact at least one side of the inner surface of the lumen to force the fluid to flow. Alternatively or in addition, an angled baffle such as baffle 9730 shown in FIG. 97D may be used. The angle of baffle 9730 may be about 45 degrees, about 10 to 80 degrees, or any suitable angle. The angled baffle or the flattened region can be used in combination with any of the drainage tube / lumen structures shown herein.

[0375] FIG. 98A is a diagram showing a sensing Foley catheter system according to an embodiment in which the drainage lumen area increases and decreases. Valve 9832 may be incorporated within the drainage tube above the cassette, within the cassette, or at any location along the drainage lumen, as shown in FIG. 98D. The upper and lower areas of the bulb portion may be substantially the same, as shown in FIG. 98B, or alternatively, the area below the bulb may be smaller than the area above the bulb. The reduced drainage lumen region portion 9834 may be relatively short, for example, portion 9834 may be about 1 mm to 10 mm in length. Alternatively, portion 9834 may be about 10 mm to 20 mm in length. Alternatively, portion 9834 may be about 10 mm in length. FIG. 98C is a diagram showing an embodiment in which the constriction 9836 includes two or more reduced region fluid drainage lumens. This can increase the surface contact of the drainage tube lumen without significantly reducing the area of the drainage tube lumen. Constriction 9836 may be used in combination with valve 9832 or without a valve.

[0376] Note that any of the bubble reduction embodiments included in this specification can be used anywhere within the drainage lumen, including the drainage tube outside the cassette and the drainage tube / lumen within the cassette. For example, FIG. 98D shows an embodiment similar to that shown in FIG. 98B where the bulb portion is within the cassette.

[0377] FIG. 99A shows a detection Foley catheter system according to an embodiment where at least a portion of the drainage lumen is rough enough to cause bubbles to disperse and / or escape as a puff.

[0378] FIGS. 99B and 99C show another bubble reduction embodiment. In this embodiment, a grid, or honeycomb, or mesh is provided inside the base of the drainage tube. The mesh may be periodically compressed to assist in breaking up bubbles, and also to sweep the fluid region and assist in breaking up bubbles.

[0379] Alternatively, or in addition, a flat mesh may be inserted anywhere within the system, such as at the junction of the drainage tube / urine collection container.

[0380] In some embodiments, at least one of the cassette and the drainage lumen may be vibrated continuously or intermittently to break up bubbles.

[0381] Figures 100A through 100C are diagrams showing embodiments incorporating a floating or non-floating plate for compressing or decomposing bubbles at or near the surface of urine in a urine collection container. The plate may simply float on the surface and passively rise and fall according to the amount of urine in the container, or the plate may be actively moved up and down. Also, the plate may be fixed. The plate may be porous or solid. In embodiments where the plate is on the surface of the fluid, the plate may also be used for urine output measurement. The position of the plate can be identified by ultrasonic, visual means (such as a camera), laser, or other technologies. The volume of the fluid in the urine collection container can be directly determined from the position of the fluid determinable by the position of the plate.

[0382] The interior of the cassette may be rectangular or other shapes. For example, the inner side of the interior of the cassette may be tapered inward toward the bottom so that there is a larger upper surface of urine with respect to the amount of urine in the cassette. As a result, more accurate urine volume measurement will be possible with a small amount of urine volume.

[0383] In some embodiments, it may include a volume measurement baffle at a set volume mark, for example, 50 mL. This volume measurement baffle may be similar to the baffle 2302 shown in FIG. 23 except that it reaches a predetermined volume position. When the upper surface of the urine volume in the cassette is at or near the position of the urine volume baffle, the ultrasonic signal becomes stronger than in other cases. For example, the volume measurement baffle may be arranged such that when the upper surface of the urine volume is about 50 ml (or other set volume), the upper surface of the urine volume is at or near the position of the volume measurement baffle. When the two surfaces (urine and volume measurement baffle) approach or contact each other, the ultrasonic signal becomes the strongest.

[0384] In some embodiments, it may include a wave guide that aids in considering the tipping of the reservoir. For example, the ultrasonic signal may be oriented within a cylinder having a flat or curved side surface such that the ultrasonic waves are oriented towards the surface of the fluid within the reservoir so that the ultrasonic waves reflect back. The wave guide may extend in all or some directions within the reservoir. The wave guide may extend between the ultrasonic transducer / sensor and the surface of the fluid.

[0385] In some embodiments, the ultrasonic transducer / sensor may be flat, and in some embodiments, the surface of the ultrasonic transducer / sensor may be curved, such as a convex curve for example. The convex curve aids in spreading the ultrasonic signal over a greater number of angles, thereby aiding in ensuring that a portion of that angle is reflected from the surface of the fluid within the reservoir.

[0386] Some embodiments include a control unit that uses an accelerometer to measure the inclination of the reservoir and then uses the inclination angle to calculate the volume of fluid remaining within the reservoir (i.e., in the low corner of the reservoir) after the fluid has emptied from the reservoir. By adding this calculated remaining amount within the reservoir to the total urine volume calculation, the accuracy can be improved.

[0387] FIG. 101A shows a sensing Foley catheter system according to one embodiment that includes valves at both the drainage port 10102 and the inlet point 10104 where the drainage tube connects to the urine collection container. Thereby, the control unit can periodically pressurize the urine collection container to reduce bubbles and / or assist in draining the urine collection container. This inlet port valve can also stop the flow of urine into the urine collection container by the control unit while emptying the urine, which may result in a more accurate measurement of urine output.

[0388] FIG. 101B is a diagram showing a urine collection container according to one embodiment that makes the overflow path of urine longer and / or convex / serpentine and / or narrower. In such a configuration, it becomes difficult for air bubbles to flow into the overflow path, and the measurement of urine volume becomes inaccurate. The overflow path may include one or more path angles greater than 45 degrees.

[0389] FIG. 101C is a diagram showing an embodiment of a urine collection container in which the fluid path (indicated by the dashed arrow) between the urine in the reservoir and the cassette pump interface 1148 is convex and long to prevent wetting of the interface 1148. The cassette pump interface 1148 may include a gas permeable, liquid impermeable, filter. The fluid path may be about 6 to 12 cm in length. Alternatively, the fluid path may be between about 3 and 6 cm in length. Alternatively, the fluid path may be longer than about 12 cm. Alternatively, the fluid path may be between about 3 cm and about 6 cm in length. Alternatively, the fluid path may be longer than about 20 cm.

[0390] FIG. 101D is a diagram showing another embodiment of a urine collection container in which the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is convex and long to prevent wetting of the interface 1148. The convex path may include a coiled or bundled small-diameter tube 10108 as all or part of the fluid path. Preferably, the convex path is three-dimensionally convex.

[0391] FIG. 101E is a diagram showing another embodiment of a urine collection container in which the fluid path (indicated by the dashed line) between the urine in the reservoir and the cassette pump interface 1148 is convex and long to prevent wetting of the interface 1148. This embodiment includes both a small-diameter tube 10108 and a convex path molded into the cassette. The convex path may be partially molded, partially a tube, all a tube, or all molded.

[0392] The inner diameter of the small-diameter tube 10108 may be about 1.8 to 2.0 mm. In some embodiments, the ID may be about 1.6 to 1.8 mm. In some embodiments, the ID may be about 1.4 to 1.6 mm. In some embodiments, the ID1 may be about 1.2 to 1.4 mm. In some embodiments, the ID may be about 1.0 to 1.2 mm. In some embodiments, the ID may be about 0.8 to 1.0 mm. In some embodiments, the ID may be about 0.5 to 0.8 mm. In some embodiments, the ID may be about 0.2 to 5 mm. In some embodiments, the ID may be less than about 4 mm. In some embodiments, the ID may be less than about 3 mm. In some embodiments, the ID may be less than about 2 mm.

[0393] Some embodiments include a drainage tube having a small-diameter inner lumen. For example, in some embodiments, the diameter of the inner lumen is about 2 mm. In some embodiments, the diameter of the inner lumen is about 1 mm. In some embodiments, the diameter of the inner lumen is about 3 mm. In some embodiments, the diameter of the inner lumen is less than about 2 mm, and in some embodiments, the diameter of the inner lumen is less than about 1 mm. In some embodiments, the diameter of the inner lumen is less than about 3 mm.

[0394] In some embodiments, the drained urine can be used to "wash" air bubbles in the drainage tube or urine collection reservoir. The urine can be recirculated into the drainage tube to increase the volume within the drainage tube and to assist in "washing" air bubbles in at least one of the tube and the reservoir. The control unit compensates for the recycled urine when calculating the urine output volume.

[0395] In some embodiments, pressurized air may be introduced into at least one of the drainage tube and the urine collection container. The forced air pops and / or compresses the bubbles and also forces the urine upward against the surface of the system to reduce 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.

[0396] Leveling

[0397] In embodiments where the urine volume is measured in the urine collection container using ultrasonic waves, it is important that the ultrasonic waves have a surface (i.e., the surface of the urine volume) that is approximately 90 degrees away from the ultrasonic sensor. Also, if the system tilts even slightly, the ultrasonic sensor may not be able to detect the surface of the urine, and accurate urine volume measurements may not be obtained. To compensate for this, the urine collection container or the base / control unit may be attached to the bed via a self-leveling attachment, and the attachment is provided on rollers, for example, such that gravity automatically levels the base when attached.

[0398] In some embodiments, slight angles within the system are processed by creating a "rough" surface on the urine volume in the urine collection reservoir. The "rough" surface provides multiple angles for ultrasonic reflection, some of which are approximately 90 degrees from the ultrasonic sensor / transducer. The roughness may be caused by bubbling the urine with air or other gas, or by vibrating at least one of the urine collection reservoir and the urine. The vibration can be mechanical, ultrasonic, etc. As the floating plate floating on the urine surface, one with a rough lower surface, one with a concave lower surface, or one with a convex lower surface may be used. The floating beads have a diameter too large to exit the reservoir when urine is discharged, so they remain in the reservoir when urine is discharged. To prevent the beads from entering the overflow area, mechanisms such as a mesh, constriction, or small-diameter opening may be used. In addition, as described above, in order to accurately measure the urine volume, an angled baffle or an angled wall or tapered wall cassette (or urine collection chamber) may be used.

[0399] Priming of the pressure balloon

[0400] To adjust the pressure of the pressure balloon, mainly for optimal pressure sensing 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. The restrictor allows the priming pump to operate with a smaller amount of air for more accurate pressure balloon priming. The restrictor can include a foam insert, a constriction of the fluid lumen, or any other suitable restrictor.

[0401] General improvements

[0402] In some embodiments, sensors located in the bed, on the patient, within the Foley catheter sensing system, or elsewhere detect whether the patient is in the supine position or not. The pressure measured within the bladder may increase when the patient is not in the supine position, which may adversely affect the data for analysis by the control unit. As a result, the control unit may ignore the pressure data collected while the patient is not in the supine position, or may stop collecting the pressure data during this time. Alternatively, the pressure measurement itself may be used to detect when the patient is not in the supine position. A sudden increase in pressure or an increase beyond a certain threshold may indicate that the patient is sitting, moving, coughing, etc. Different pressure profiles may indicate different events. The patient's turning over to prevent bedsores may be tracked in this way.

[0403] In some embodiments, electrocardiogram measurements obtained via leads attached to the Foley catheter sensing system or obtained independently are used to synchronize the heart rate measured via the heart rate within the bladder with the electrocardiogram.

[0404] In some embodiments, the angle of the bed may be used by the control unit as an input parameter for calculation results such as IAP or APP. For example, raising the angle of the body (raising the position of the patient's head) leads to an increase in IAP. This increase may be different for healthy patients and those who are not. As a result, additional information regarding the patient's health may be obtained by determining the IAP at different bed angles. Also, to temporarily stabilize a patient with a high IAP, the IAP may be lowered by lowering the head position.

[0405] In some embodiments, the sensing Foley catheter has at least one pressure sensor or lumen in fluid communication with an external pressure sensor. This pressure sensor will be able to detect the pressure within the lumen rapidly or at high frequency (ideally faster than 1 Hz), enabling monitoring of physiological signals within the lumen. In some embodiments, the pressure lumen may 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 may be inflated and / or deflated while the pressure exerted by the body on the pressure balloon is being monitored. The pressure lumen is capable of transmitting pressure waves from the body cavity, one of which is the pulsation of the heart generated by the inflow of blood into the lumen organ and / or the surrounding tissue. The pulsatile pressure from at least either one of the heart pulsation and respiratory movement can be used to measure the pressure of the lungs and the cardiovascular system. Additionally, the pressure within the pressure lumen / balloon may increase above a threshold (i.e., 100 mmHg) to determine the origin of the pulse pressure, the disappearance point of the pulse pressure, and / or the relative increase / decrease in the pulse pressure size, and then slowly decrease through the detection range. The origin / disappearance point or relative increase / decrease of the pressure pulsation detected by the pressure sensor can be correlated with blood pressure, perfusion pressure, mean arterial pressure, stroke volume, variation in stroke volume, respiratory effort, pulmonary pressure transmission, and other lung, gastrointestinal, renal, or cardiovascular system parameters. This process is similar to that of a blood pressure cuff, where after raising the pressure within the cuff above the blood pressure, the pressure within the cuff is slowly decreased until the blood pressure waveform (heartbeat) appears or disappears.

[0406] Figure 102 is a diagram showing the pressure waveform when the pressure balloon expands and its disappearance. Note that above the mean arterial pressure, the pulsation of the heart decreases and / or disappears. If there is sufficient data to correlate the degree of disappearance at the relative pressure point with the mean arterial pressure, the mean arterial pressure can be derived from this relative pressure waveform. The same can be used for pulmonary artery pressure and other pressures detectable within the body cavity, such as pulmonary pressure.

[0407] In some embodiments, the pressure sensor / rumen is a capsule, or balloon, or reservoir that can be slowly inflated or filled while pressure is being monitored using an external transducer. In some embodiments, the pressure sensor is associated with a urinary catheter such as a Foley catheter. Alternatively, the pressure sensor may 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 tissue perfusion embodiments, pressure sensing may be within the urethra or against the luminal surface, and pulse oximetry may be performed to detect blanching and / or perfusion of the luminal tissue at each pressure to determine tissue perfusion pressure.

[0408] 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 electrocardiogram signal internally, such as via the urethra or bladder, or externally, such as via sensors placed on the legs or waist. This signal can be used to synchronize other measurement parameters (such as stroke volume) that are synchronized with the cardiac cycle with the electrical signal, and noise can be removed by taking an average or median signal from many individual samples. In another embodiment, the respiratory signal is used to guide which cardiac pressure signal should be used for stroke volume variation analysis by waiting for a model waveform to appear before performing the analysis.

[0409] FIG. 103 is a diagram illustrating a method of synchronizing a cardiogenic signal (such as pressure fluctuations in the bladder caused by the pulse of the nearby abdominal aorta) to obtain a clean signal for analysis. When an electrocardiogram is captured in synchronization with another cardiac signal of interest, individual samples can be synchronized using, for example, the R-wave of the electrocardiogram. In this figure, a plurality of pressure samples are captured and subsequently overlapped using the R-wave of the electrocardiogram for alignment. Next, the median signal is calculated by taking the median of all pressure samples at the same time during the cardiac cycle. The average value could also be used. In this way, random noise is filtered out and removed because an abnormally high value due to noise in one sample is canceled out by an abnormally low value in another sample. As more data points are added, the underlying signal becomes stronger and can be used for analysis. For example, in the illustrated pressure signal, the amplitude between the peaks of the signal can be used to derive the relative stroke volume.

[0410] FIG. 104 is a diagram showing a method of informing cardiac pressure signal analysis using a respiratory pressure signal to determine stroke volume variation (SVV). This method is particularly useful in non-ventilated patients, i.e., patients not using a ventilator. Existing stroke volume measurement techniques, such as thermodilution and pulse contour analysis, have limited ability to measure stroke volume variation (the variation in stroke volume between inspiration and expiration) because the respiratory cycle is not visible. Using intraluminal pressure such as a Foley catheter in the bladder as described herein is advantageous in that it can capture respiratory and cardiac signals simultaneously (the same is true for the more slowly moving intra-abdominal pressure). Thus, the device of the present invention can discriminate and select a respiratory cycle for use in analyzing stroke volume variation because certain characteristics (such as the speed and magnitude of respiration, etc.) are suitable for appropriate analysis. This figure shows a sample pressure signal taken from the bladder. In the upper raw pressure signal, large variations are due to respiration and are selected for analysis based on, fo...

Claims

1. 1. A system for assessing a patient's health status, comprising: a drainage tube (1001; 1012) configured to be in fluid communication with at least one opening located near or at the distal end of the catheter (102; 1000); a urine collection reservoir (1022) in fluid communication with the drainage tube (1001; 1012) for receiving a volume of urine from the patient, the urine collection reservoir (1022) being configured to empty when a predetermined volume within the urine collection reservoir (1022) is reached; a controller in communication with the urine collection reservoir (1022), the controller being configured to measure the volume of urine in the urine collection reservoir (1022); Equipped with the controller is configured to monitor the urine volume over a first time period when it is determined that the urine volume from the patient exceeds a urine volume threshold; the control unit is further configured to monitor the urine volume from the patient over a second time period after the first time period and measure a second urine volume over the second time period; The control unit is further configured to determine a risk of acute kidney injury (AKI) when the second urine volume from the second period is below the urine volume threshold and the urine volume from the first period shows a decreasing trend.

2. The system of claim 1 , further comprising a valve configured for unidirectional flow and configured to be in fluid communication with the drainage tube (1001; 1012).

3. 2. The system of claim 1, further comprising a pump (2918; 3106; 6606) in fluid communication with the drainage tube (1001; 1012) and configured to apply negative pressure to the drainage tube (1001; 1012).

4. 4. The system of claim 3, wherein the pump (2918; 3106; 6606) is configured to operate cyclically.

5. 4. The system of claim 3, wherein the control unit is configured to communicate with the pump (2918; 3106; 6606) and to operate the pump (2918; 3106; 6606) to apply negative pressure to eliminate an airlock from the drainage tube (1001; 1012).

6. 6. The system of claim 5, wherein the control unit is further configured to operate the pump (2918; 3106; 6606) to apply the negative pressure at a first level and then at a second level to eliminate an airlock from the drainage tube (1001; 1012).

7. 7. The system of claim 6, wherein the control unit is further configured to operate the pump (2918; 3106; 6606) to apply the negative pressure at the second level immediately after the airlock is cleared from the drainage tube (1001; 1012).

8. 7. The system of claim 6, wherein the control unit is further configured to operate the pump (2918; 3106; 6606) to apply the negative pressure at the second level for a predetermined period of time after the airlock is cleared from the drainage tube (1001; 1012).

9. The system of claim 1 , wherein the control unit is configured to collect the urine volume on at least an hourly basis.

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

11. The system of claim 1 , wherein the first period of time is at least three hours.

12. The system of claim 11 , wherein the second period of time is three hours or less.

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

14. The system of claim 1 , wherein the control unit is further configured to determine the risk of AKI based on the patient's urine volume and weight.

15. The system of claim 1 , wherein the control unit is further configured to determine the risk of AKI based on the patient's urine volume and intra-abdominal pressure.

16. The system of claim 15, wherein the control unit is further configured to determine the risk of AKI based on the urine volume and the intra-abdominal pressure and temperature of the patient.

17. The system of claim 1 , wherein the control unit is further configured to determine the risk of AKI based on the patient's urine volume and heart rate.

18. The system of claim 1 , wherein the control unit is further configured to determine the risk of AKI based on the patient's urine volume and respiratory rate.

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