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WO2018208734A1 - Systèmes de cathéter urinaire à demeure de diagnostic, et procédés associés - Google Patents

Systèmes de cathéter urinaire à demeure de diagnostic, et procédés associés Download PDF

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Publication number
WO2018208734A1
WO2018208734A1 PCT/US2018/031530 US2018031530W WO2018208734A1 WO 2018208734 A1 WO2018208734 A1 WO 2018208734A1 US 2018031530 W US2018031530 W US 2018031530W WO 2018208734 A1 WO2018208734 A1 WO 2018208734A1
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WO
WIPO (PCT)
Prior art keywords
measurement container
pressure
enclosed
conduit
urinary
Prior art date
Application number
PCT/US2018/031530
Other languages
English (en)
Inventor
Reuben E. Kron
Stephen J. Kron
Original Assignee
Biofluid Technology, Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biofluid Technology, Inc filed Critical Biofluid Technology, Inc
Publication of WO2018208734A1 publication Critical patent/WO2018208734A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A61B5/205—Determining bladder or urethral pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A61B5/208—Sensing devices adapted to collect urine adapted to determine urine quantity, e.g. flow, volume

Definitions

  • the present disclosure relates to the field of indwelling catheters.
  • the present disclosure also relates to the field of urinary tract function assessment.
  • CAUTI catheter-associated urinary tract infections
  • CAUTI CAUTI
  • Catheters are usually placed as a prophylactic measure when general anesthesia for major surgery may result in post-operative bladder dysfunction. Otherwise, catheter placement is often a method to assist in management of elderly, bedridden, or incontinent patients. At present, about 20% of patients are catheterized at some time during hospitalization. About 25%) of these patients will develop asymptomatic bacteriuria, and about 25% of these will progress to a urinary tract infection (UTI). Of those with UTI, about 3% will develop bacteremia.
  • UTI urinary tract infection
  • the standard for assessing urinary function in a patient who has a catheter is to remove the catheter and assess the patient's ability to urinate without the catheter. If the patient's ability to urinate is less than satisfactory, a new catheter is placed in the patient, and the process begins anew when the clinician has determined that enough time has passed (hours, days) that a new urinary function assessment is warranted.
  • the objective in most cases is to determine when the bladder has recovered after surgery to a point where the indwelling catheter (a so-called Foley catheter) can be safely removed.
  • the present disclosure first provides urinary diagnostic systems, comprising: a urethral conduit (e.g., a catheter or stent) adapted for indwelling deployment, the conduit having a lumen; an enclosed measurement container having an interior volume configured to contain urine passed from the lumen of the conduit; a valve capable of (a) placing the lumen of the catheter into fluid communication with the enclosed measurement container and (b) interrupting the fluid communication between the lumen of the conduit and the enclosed measurement container; the system being configured to measure at least one of (a) the weight or a change therein of the enclosed measurement container, (b) the weight or a change therein of contents of the enclosed measurement container, and (c) a pressure or a change therein within the enclosed measurement container.
  • a urethral conduit e.g., a catheter or stent
  • an enclosed measurement container having an interior volume configured to contain urine passed from the lumen of the conduit
  • a valve capable of (a) placing the lumen of the catheter into fluid communication with the enclosed measurement container and (b
  • the present disclosure also provides methods of assessing urinary tract function, comprising: collecting, in an enclosed measurement container in sealed fluid communication with an indwelling conduit of a patient, urine passed through the indwelling conduit ; and measuring at least one (or more) of (a) the weight or a change therein of the enclosed measurement container, (b) the weight or a change therein of the contents of the enclosed measurement container, or (c) a pressure or a change thereof within the enclosed measurement container.
  • urinary diagnostic systems comprising: a
  • measurement container configured to contain urine expressed from a subject; a conduit capable of communicating urine expressed from the subject to the measurement container; a flow control device configured to modulate urine flow from the subject to the measurement container; and one or both of (a) a device configured to measure a pressure within the measurement container or (b) a device configured to measure a weight of the measurement container.
  • methods of assessing urinary tract function comprising: collecting, in a measurement container in sealed fluid communication with an indwelling conduit of a patient, urine passed through the indwelling conduit; and measuring at least one of (a) the weight or a change therein of the enclosed measurement container or (b) the weight or a change therein of the contents of the enclosed measurement container.
  • FIG. 1 provides a depiction of an illustrative system according to the present disclosure
  • FIG. 2 depicts an illustrative system according to the present disclosure
  • FIG. 3 provides an illustration of a system according to the present disclosure, including the various pressures that can be present in a system according to the present disclosure
  • FIG. 4 provides representative flow vs. pressure curves for an exemplary subjects that exhibit, respectively, normal condition, an obstructed urethra, and a weak bladder;
  • FIG. 5 provides a pressure v. time curve for urination by an exemplary subject having normal urinary tract condition
  • FIG. 6 provides a pressure v. time curve for urination by an exemplary subject having an obstructed urinary tract
  • FIG. 7 provides a flow v. pressure curve for the normal subject of FIG. 5;
  • FIG. 8 provides a flow v. pressure curve for the obstructed subject of FIG. 6;
  • FIG. 9 provides comparative flow vs. pressure curves for the normal and obstructed subjects of FIGs. 5 and 6;
  • FIG. 10 provides a depiction of an exemplary system according to the present disclosure.
  • Ranges can be expressed herein as from one particular value, and/or to another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent 'about,' it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as "about” that particular value in addition to the value itself. For example, if the value " 10" is disclosed, then “about 10" is also disclosed.
  • each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
  • the terms "about” and “at or about” mean that the amount or value in question can be the value designated some other value approximately or about the same. It is generally understood, as used herein, that it is the nominal value indicated ⁇ 10% variation unless otherwise indicated or inferred. The term is intended to convey that similar values promote equivalent results or effects recited in the claims.
  • amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but can be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.
  • an amount, size, formulation, parameter or other quantity or characteristic is “about” or “approximate” whether or not expressly stated to be such. It is understood that where "about” is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise.
  • additional optional additives means that the additives can or cannot be included and the description includes aspects that include and both do not include additional additives.
  • a Foley catheter is connected to the closed air space of either a standard (i.e., with a vacuum chamber) or simplified (i.e., without a vacuum chamber) container, which container can be a consumable component (termed
  • a balloon of the catheter can be inflated so as to maintain the catheter's position in the bladder and through the urethra.
  • the connection between the closed air space of a container (identified as “UED” in FIG. 1) and the catheter can be achieved by means of a connector (including connectors having proprietary or otherwise unique engagement features, described elsewhere herein) that assures an air and water tight seal is achieved. It is not a requirement in all embodiments that this connection be formed by a proprietary connector.
  • a system 10 may include a catheter 104 that is deployed into the urethra 103 of a subject.
  • Catheter 104 may include a balloon 102, which maybe inflated to retain urine in the bladder and deflated to allow urine passage.
  • Catheter 104 may be a Foley catheter; the balloon on the Foley catheter is designed to retain the catheter within the bladder . The balloon is inflated after insertion. A clamp can be applied to the external part of the catheter to cut off flow.
  • Catheter 104 may be connected to a container or urethral extender device 108, which may be closed (e.g., air-tight) to the exterior environment, though this is not a requirement.
  • the connection may be accomplished by a connector 105.
  • the connector may be a valve (e.g., a 2- or 3- way valve).
  • the connector and urethra may be mated via a proprietary or otherwise unique feature or set of features that allows for the connector to be used only with a specific valve and/or container.
  • the connector 105 can be used to direct urine to a urine collection device 109 (not shown) and can also be used to direct urine through path 110 to a urethral extender device 108.
  • the urethral extender device 108 may be connected via connector 107 to a user interface 106, which may be a graphical user interface.
  • the connection may be wired or wireless.
  • a connector can serve as a clamp (e.g., a 2- or 3 -position valve) that acts to occlude the catheter so that bladder filling will take place prior to testing for the recovery of bladder function.
  • the connector can be adjusted so as to permit continual or intermittent flow of urine, e.g., into a collection vessel.
  • the connector and valve can share a comparatively large bore to minimize resistance to flow.
  • the entire flow system can be sealed to prevent bacterial seeding from the environment.
  • the catheter e.g., a Foley catheter
  • the on/off valve is opened between the catheter and the container. The subject is instructed to initiate urination, and the pressure within the closed air space of the disposable is recorded and analyzed.
  • a normal male has a high maximum flow rate at a moderate maximum bladder pressure; an obstructed patient has a low maximum flow rate at a high maximum bladder pressure, and; a patient with a weak bladder demonstrates low maximum flow rate with a low maximum bladder pressure.
  • elderly male patients demonstrate various combinations of both urethral obstruction (e.g., BPH) and bladder dysfunction (e.g., detrusor failure).
  • the rate at which back-pressure increases reflects the resistance to flow in the catheter (a fixed value depending on the known physical characteristics of the catheter, such as length and diameter), so the slope of the flow-pressure curve (which is mathematically derived from the pressure-time curve) partials out the contribution to volumetric flow attributable to the strength of bladder contraction versus the flow resistance of the catheter.
  • the relationship of flow to pressure is shown by the slope of the flow-pressure curve. This relationship represents the resistance to flow in the catheter during laminar flow.
  • FIG. 4 attached hereto illustrates the use of the NUC as a uroflowmeter and a cystometer, as the NUC simultaneously measures urine flow rate and strength of bladder contraction without the need for a catheter.
  • the data in FIG. 4 demonstrate representative Flow-Pressure curves generated by the NUC.
  • the "normal” subject achieves high urine flow at low bladder pressure, while the “obstructed” subject produces low urine flow at high bladder pressure.
  • the "weak bladder” subject produces low flow with low pressure.
  • the container can be in communication with one or more other modules, e.g., a graphical user interface (GUI) and/or other modules.
  • GUI graphical user interface
  • a module can measure the pressure (or change therein) within the container as a function of time (described below), and display those data.
  • a module can also measure the weight of the container (or of the chamber's contents) as a function of time, which weight vs. time data can also be used to assess urinary tract function.
  • a catheter can be modeled as a capillary tube of known dimensions, it can display a linear relationship between pressure and flow in the laminar flow range of shear- rate independent viscosity fluids such as water and urine. Therefore, it is not always necessary to expose the lower urinary tract to full bladder pressure to determine bladder strength (thereby avoiding the risk of reflux, especially in elderly men with very high isovolumetric bladder pressure due to compensatory detrusor hypertrophy from chronic obstruction caused by enlarged prostate).
  • the disclosed systems can be set to provide a very mild backpressure probe (e.g., 0 mm to 30 mm Hg pressure-time curves) by relieving the back-pressure of the closed air space within the disposable to 0 mm Hg whenever the pressure-time curve reaches, e.g., about 30 mm Hg.
  • a very mild backpressure probe e.g., 0 mm to 30 mm Hg pressure-time curves
  • This procedure in turn generates multiple pressure-time curves during a single urination and the resulting data emulate that of invasive cystometry, but the procedure is more physiologic since the bladder filling is natural. This process also avoids introducing any foreign materials into the bladder from the environment, thus minimizing the risk of trauma, infection, etc.
  • One advantage of the disclosed technology over existing approaches is that the test is performed under physiological conditions. As the subject urinates into the device, pressure and flow are measured simultaneously. The resulting Flow-Pressure curve can help differentiate between obstruction and contraction as the source of diminished urine flow.
  • a urinary diagnostic system comprising: [0062] a urethral conduit adapted for indwelling deployment, the catheter having a lumen; an enclosed measurement container having an interior volume configured to contain urine flowing from the lumen of the catheter;
  • a valve capable of (a) placing the lumen of the catheter into fluid
  • the system being configured to measure at least one of (a) the weight (or a change therein) of the enclosed measurement container, (b) the weight (or a change therein) of contents of the enclosed measurement container, and (c) a pressure (or a change therein) within the enclosed measurement container.
  • the urethral conduit can be, e.g., a catheter, or even a urethral stent.
  • the conduit can be straight, curved, rigid, or flexible. So-called Foley catheters are considered especially suitable for the disclosed technology.
  • the enclosed measurement container can be a rigid container, e.g., one formed from plastic or metal.
  • the enclosed measurement container suitably includes a port or other access path to the internal volume of the container in order that one can measure the internal pressure within the internal volume of the container.
  • this port can be an aperture in the container, e.g., a hole in the side, top, or bottom of the container.
  • the port can be a hole formed in a stopper or lid of the container; the stopper or lid can also include a port through which another conduit (e.g., a catheter or even a tube in fluid connection with a catheter) enters the container.
  • another conduit e.g., a catheter or even a tube in fluid connection with a catheter
  • the container is a bottle with a stopper, the stopper having at least two holes, through one of which holes the system monitors the pressure within the bottle, and through the other of which holes urine from a subject is communicated into the internal volume of the container, e.g., via a catheter.
  • the interior volume of the container can be of virtually any shape, e.g., cylindrical, spherical, polygonal, or otherwise.
  • the container can be characterized as being disposable, although a container can be re-used for multiple tests of the same subject or of different subjects.
  • a container can be configured to stand up or even to engage with a cart, system, stand, or other unit.
  • a container is part of a system (e.g., roll-able or otherwise portable) placed into fluid connection with a first subject, which subject then undergoes an assessment of urinary tract condition. The testing of that subject can be repeated at a later time.
  • the system can also be transported to the location of another subject, which other subject is then analyzed by the system. Alternatively, subjects can be brought to the system.
  • the disclosed systems allow for bedside, at-home, and in-office monitoring of patients.
  • a valve of the disclosed systems can be a valve that has two positions (open and closed; a two-position valve), but a valve can have three, four or more positions.
  • the valve can be actuated (manually or in an automated fashion) to open and interrupt fluid communication between a urethral conduit and the interior volume of a measurement container.
  • a valve can be configured to actuate in an automated fashion in response to a pressure reading (e.g., when the pressure within the measurement container reaches a certain threshold value).
  • the valve can also be configured to actuate at a certain time (e.g., after 15 seconds of urine accumulation in the measurement container), or even after a certain amount of urine weight (e.g., 50 g) has accumulated in the measurement container.
  • a certain time e.g., after 15 seconds of urine accumulation in the measurement container
  • a certain amount of urine weight e.g., 50 g
  • the foregoing limitations can be set by a user or be pre-set into a system according to the present disclosure.
  • the system can be configured to vent pressure, to release urine, or even both in response to a pressure reading, at a certain time, or even after a certain amount of urine weight has accumulated in the measurement container.
  • the system can be configured to release pressure from the enclosed measurement container when the pressure within the measurement container reaches a certain threshold value. Pressure can also be released steadily, intermittently, or even at intervals, e.g., every 2 seconds, every 5 seconds, every 10 seconds, or at other intervals that the user may desire.
  • pressure can be added (increased) at a steady metered rate or intermittently to increase the number of flow-pressure curves (that are mathematically derived from time-pressure curves) generated from a given volume of excreted urine.
  • the additional flow-pressure curves increase the statistical significance of the flow pressure data in low volume micturitions.
  • the valve can be placed in the closed position so as to allow the patient's urine to accumulate in their bladder in order that the patient has sufficient urine for a urinary tract test.
  • the valve can then be actuated so as to place the bladder into fluid communication with the measurement container and the patient can be instructed to urinate.
  • the valve is opened according to a pre-set schedule (e.g., every 2 hours); a valve can also be opened manually or automatically on an as-desired basis.
  • the valve is a three-position valve, which can be switched between a first position in which the valve prevents fluid communication with the subject's bladder or urethra. When switched into a second position, the valve can place the subject's bladder or urethra into fluid communication with a urine collection chamber, e.g., a standard bottle or other container.
  • a urine collection chamber e.g., a standard bottle or other container.
  • the valve can place the subject's bladder or urethra into fluid communication with a urine collection container that has its internal pressure measured.
  • the valve can have a further position that places the bladder or urethra into fluid communication with another module, e.g., a module (e.g., a pump or other infuser) configured to deliver irrigation, medicine, or other material to the urethra and/or bladder.
  • a module e.g., a pump or other infuser
  • a system can be configured to, e.g., measure the weight of the enclosed measurement container and the contents of the container. This can be accomplished by, e.g., a scale that weighs the container, and the system and/or user can collect weight vs. time data. It should be understood that the system can be configured to measure the weight of the contents only of the container. A system can also be configured to measure a pressure (e.g., pressure vs. time) within the enclosed measurement container.
  • a pressure e.g., pressure vs. time
  • a user can:
  • a user can:
  • the container when a system measures a pressure within the container, the container is suitably air-tight to the environment exterior to the container. This air-tightness is not a requirement, however, when a system is configured to measure the weight of the container and/or the weight of the contents of the container. It should also be understood that the container can include therein an amount of one or more heat sink materials, e.g., a porous material, a fibrous material (e.g., metal fiber - such as steel wool, glass fiber), and the like.
  • a porous material e.g., a porous material, a fibrous material (e.g., metal fiber - such as steel wool, glass fiber), and the like.
  • Aspect 2 The urinary diagnostic system of Aspect 1, wherein the system is configured to measure one or both of the weight of the enclosed measurement container and the contents of the enclosed measurement container.
  • the weight measurement can to be accomplished gravimetrically with, e.g., an electronic recording scale or a load cell that sends its data to a computer that charts weight vs. time.
  • the resulting weight vs. time curve is converted into a flow vs. time curve and then differentiated into a flow vs. pressure curve describing the function of the bladder under known conditions of flow resistance (i.e., a known constant flow resistance due to the catheter plus an additional known but varying resistance to flow created by the buildup of back-pressure in the enclosed air space of the pressure measuring container e.g., maximum flow at zero back-pressure and no flow at back-pressure equal to bladder isovolumetric pressure).
  • the flow vs. pressure curve will yield the time-constant, magnitude and resilience of detrusor contraction under conditions that emulate the physiological conditions during normal micturition. This in turn can assist medical personnel in determining when the bladder muscle has recovered from bladder failure or from the effects of general anesthesia or any other source of reversible detrusor dysfunction, in order that caretakers can determine when the catheter can be safely removed and normal voluntary micturition reinstituted.
  • Aspect 3 The urinary diagnostic system of Aspect 2, being configured to correlate a weight (or change thereof) in the enclosed measurement container and/or the contents of the enclosed measurement container to a urinary flow rate, a bladder pressure, or any combination thereof.
  • Aspect 4 The urinary diagnostic system of Aspect 1, wherein the system is configured to measure a pressure within the enclosed measurement container.
  • the pressure can be measured, e.g., by placing the interior volume of the enclosed measurement container into fluid communication with a pressure gauge, a transducer, or other pressure-sensitive modality.
  • Aspect 5 The urinary diagnostic system of any of Aspects 1-4, wherein the system is configured to relieve the pressure within the enclosed measurement container when the pressure within the enclosed measurement container reaches a certain value.
  • the value can be an asymptote at which the pressure in the container equals bladder pressure (representing the maximum or isovolumetric bladder pressure).
  • the pressure can be relieved when the pressure reaches a comparatively lower preset value (e.g., 30 mm Hg or 60 mm Hg). At that point, the system can vent (e.g., in an automated fashion) the pressure inside the enclosed pressure measurement container.
  • Aspect 6 The urinary diagnostic system of any of Aspects 4-5, the system being configured to correlate a pressure (or change thereof) within the enclosed measurement container to a urinary flow rate, a bladder pressure, or any combination thereof.
  • Aspect 7 The urinary diagnostic system of any of Aspects 1-6, further comprising a urine collection container capable of being placed by the valve into fluid communication with the lumen of the catheter.
  • a urine collection container capable of being placed by the valve into fluid communication with the lumen of the catheter.
  • a container can be, e.g., a bedpan, a plastic bag, or other receptacle.
  • Aspect 8 The urinary diagnostic system of any of Aspects 1-7, wherein a connection between the valve and the lumen of the catheter, the enclosed measurement chamber, or both, is formed by complementary connectors.
  • such connectors permit connection between one or more of the foregoing only to a complementary connector, e.g., connectors that are uniquely complementary to one another.
  • a complementary connector e.g., connectors that are uniquely complementary to one another.
  • the connectors (and related components) can be comparatively large-bore so as to reduce resistance to flow and ease attachment.
  • the configuration (or even color) of the connectors can also be useful in preventing confusion with other equipment such as intravenous (IV) bags, valves, and other connectors.
  • IV intravenous
  • a connector can include one or more one-time deformable features (e.g., flanges) that allow for one-time use only with a module that includes a complementary feature. In this way, the components protect against competing, counterfeit, or substandard goods that might be promoted as being substitutes for the disclosed connectors.
  • a connector can include a magnet that is positioned to actuate another magnet or other feature in another complementary connector.
  • Aspect 9 The urinary diagnostic system of any of Aspects 1-8, wherein the valve is capable of interrupting fluid communication with the lumen of the conduit, so as to enable filling of the bladder of a patient having received the catheter.
  • the valve can be operated manually or in an automated fashion.
  • a system can be configured so as to actuate the valve when the pressure within the measurement container reaches a certain threshold pressure, the valve then placing the urethra into fluid communication with another container that is not air-tight to the exterior environment.
  • the system can be configured to, as described elsewhere herein, vent the pressure within the measurement chamber when that pressure reaches a certain threshold level, e.g., a pressure at which the subject might experience discomfort or damage.
  • a certain threshold level e.g., a pressure at which the subject might experience discomfort or damage.
  • Aspect 10 The urinary diagnostic system of any of Aspects 1-9, wherein the valve is characterized as having three or more positions.
  • a method of assessing urinary tract function comprising:
  • an indwelling urethral conduit e.g., a catheter or stent
  • urine passed through the indwelling conduit
  • Aspect 12 The method of Aspect 11, further comprising correlating (a) the weight (or a change therein) of the enclosed measurement container, (b) the weight (or a change therein) of the contents of the enclosed measurement container, or (c) a pressure (or a change thereof) within the enclosed measurement container to a urinary flow rate, a bladder pressure, or any combination thereof.
  • Aspect 13 The method of Aspect 11, further comprising correlating a pressure or a change in pressure within the enclosed measurement container to a urinary flow rate, a bladder pressure, or any combination thereof.
  • Aspect 14 The method of Aspect 13, further comprising relieving the pressure within the enclosed measurement container when the pressure within the enclosed measurement container reaches a certain value, e.g., either an asymptote or a preset value.
  • the pressure can be relieved in an automated fashion (as described above), or in a manual fashion.
  • Aspect 15 The method of any of Aspects 11-14, further comprising placing the conduit into fluid communication with the enclosed measurement container. This can be done by sealably inserting the conduit - or a further conduit in fluid communication thereof - into the measurement container.
  • Aspect 16 The method of Aspect 15, wherein the catheter is placed into fluid communication with the enclosed measurement container by way of a valve having two or more positions, e.g., a two-, three-, or four-position valve.
  • Aspect 17 The method of any of Aspects 11-16, further comprising interrupting fluid communication between the bladder of the patient and the enclosed
  • this can be done for the purposes of allowing the subject's bladder to fill with urine sufficient to support a urinary tract test.
  • Aspect 18 The method of any of Aspects 11-17, further comprising interrupting fluid communication between the catheter and the environment exterior to the catheter. As described elsewhere herein, this can be done for the purposes of allowing the subject's bladder to fill with urine sufficient to support a urinary tract test.
  • Aspect 19 The method of any of Aspects 11-18, further comprising exposing the interior volume of the enclosed measurement container to the environment exterior to the interior volume of the enclosed measurement container.
  • a method comprising: placing the lumen of an indwelling urethral conduit into sealed fluid communication with the interior volume of an enclosed measurement vessel, the interior volume being in fluid communication with a module configured to perform one or more of: (a) measuring a pressure or a change therein within the interior volume, (b) measuring a weight or a change therein of the enclosed measurement vessel, (c) measuring a weight of or a change therein of the contents of the enclosed measurement vessel.
  • a urinary diagnostic system comprising: a measurement container configured to contain urine expressed from a subject; a conduit capable of communicating urine expressed from the subject to the measurement container; a flow control device configured to modulate urine flow from the subject to the measurement container; and one or both of (a) a device configured to measure a pressure within the measurement container or (b) a device configured to measure a weight of the measurement container.
  • a measurement container can be rigid, e.g., a graduated cylinder or bedpan.
  • a measurement container can also be flexible in nature.
  • a conduit can extend from the
  • the conduit can be integrated into the
  • the conduit and measurement container can be constructed such that one has a feature that uniquely engages with a feature of the other. In this way, one can prevent counterfeit or unauthorized conduits and measurement containers being used together.
  • Such an arrangement can be considered "co-devices" in the sense that one is only connectable to the other. This can also be used so that a user can obtain both devices (i.e., conduit and
  • Aspect 22 The urinary diagnostic system of Aspect 21, wherein the conduit is characterized as an indwelling urethral catheter.
  • the conduit - even in catheter form - can include a feature that uniquely engages with a feature of the measurement container.
  • Aspect 23 The urinary diagnostic system of any of Aspects 21-22, wherein the flow control device comprises a valve.
  • a two-, three-, or multi-position valve can be used.
  • a valve that has a first position that allows urine to flow into the measurement container and a second position that allows urine to flow to a collector or "dump" can be used.
  • Aspect 24 The urinary diagnostic system of any of Aspects 21-23, wherein the flow control device comprises a constrictor.
  • a constrictor can be a collar that contracts so as to at least partially close the interior lumen of the conduit.
  • a constrictor can also be a clamp or other device that can partially or completely close the interior lumen of the conduit.
  • Aspect 25 The urinary diagnostic system of Aspect 24, wherein the constrictor is configured to effect at least partial closure of the conduit.
  • Aspect 26 The urinary diagnostic system of Aspect 24, wherein the constrictor comprises a solenoid.
  • a solenoid can be used to exert a piston or other piece against the conduit so as to at least partially close the conduit.
  • Aspect 27 The urinary diagnostic system of any of Aspects 21-26, further comprising a heat sink material disposed within the measurement container. Suitable such materials can be solid, porous, or even fibrous. Glass and metal wools (e.g., copper, steel, iron, aluminum) are considered suitable heat sink materials.
  • the heat sink material can be a phase change material, e.g., a wax.
  • Aspect 28 The urinary diagnostic device of any of Aspects 21-27, wherein the measurement container is sealed against the environment exterior to the measurement container.
  • the measurement container can be sealed such that the measurement container can maintain an increased (or decreased) pressure within.
  • Aspect 29 The urinary diagnostic system of Aspect 28, wherein the system is configured to relieve a pressure within the measurement container when the pressure within the measurement container reaches a certain value. This can be accomplished by a valve that is constructed to release upon experiencing a certain predetermined pressure. This can also be accomplished by using a sensor to detect a pressure within the measurement container and then releasing pressure within the measurement container (e.g., via an actuated valve) in response to the pressure detected by the sensor.
  • Aspect 30 The urinary diagnostic system of any of Aspects 21-29, comprising a device configured to measure a pressure within the measurement container, and the system further comprising a processor configured to correct for diabatic effects on or of urine within the measurement container.
  • the processor can consider one or more of, e.g., ambient temperature, urine temperature, or ambient pressure, and then calculate a correction.
  • the Ideal Gas Laws and the Hagen-Poiseuille Law can describe the physics of a system in which one measures the flow of a non-shear rate dependent fluid (e.g., urine, water) through a catheter into a closed air chamber. Under ideal conditions (e.g., constant temperature), there is a linear relationship between the air pressure within a closed air chamber and the volumetric flow of a non-compressible fluid into that closed air chamber.
  • a non-shear rate dependent fluid e.g., urine, water
  • measurement of pressure and pressure change within the closed air space of the urine reservoir within the UED can be affected by factors that alter the temperature and/or pressure of the enclosed air, one can (1) correct for the temperature change (e.g., diabatic effect) caused by compression (and decompression) of air, and/or (2) mitigate the diabatic effect with an appropriate method (e.g., a heat sink distributed within the closed air space).
  • the effects of ambient temperature (i.e., room temperature) and urine temperature (i.e., body temperature) and ambient air pressure (i.e., atmospheric pressure) that contribute to the relationship of pressure and flow volume can be measured and factored into the equation when translating pressure measurements into volumetric flow measures.
  • the diabatic effect can be a source of error (>20%) when extrapolating maximum flow, and is reduced over a magnitude ( ⁇ 2%) when a heat sink is placed in the closed air chamber. It should be understood that it is not a requirement to correct for the diabatic effect.
  • Aspect 31 The urinary diagnostic system of any of Aspects 21-30, wherein the device configured to measure a weight of the measurement container is a load cell.
  • Aspect 32 The urinary diagnostic system of any of Aspects 21-31, wherein the urinary diagnostic system is configured to obtain (a) a flow vs. pressure relationship for urine expressed from the subject to the measurement container, (b) a volume vs. time relationship for urine expressed from the subject to the measurement container, (c) a weight vs. time relationship for urine expressed from the subject to the measurement container, (d) a pressure vs. time relationship for urine expressed from the subject to the measurement container, or any combination of (a), (b), (c), and (d).
  • a user might clamp the conduit for a time sufficient (e.g., 2-3 hours) to allow sufficient urine to build up in a patient's bladder.
  • the clamp could then be released (e.g., in an automated fashion), and the patient would then express urine into the measurement container.
  • the system might then obtain a urine flow vs. pressure relationship. By determining the slope of the flow vs. pressure curve, the system can then determine whether the patient is possessed of normal bladder function, weak bladder function, or even an obstruction in the lower urinary tract.
  • the catheter can serve as the "capillary tube" in the Hagen-Poiseuille Law, imposing a linear resistance to laminar flow such that a non-shear rate dependent fluid, such as urine, demonstrates a linear relationship between bladder pressure and urine flow rate.
  • a strong bladder will have a high flow rate
  • a weak bladder will have a slow flow rate under the same test conditions.
  • the pressure vs. time curves generated by the weak bladder will have longer time constants than those generated by the stronger bladder.
  • the flow vs. pressure curves derived from the pressure vs. time curves can extrapolate to lower isovolumeteric bladder pressures for the weak bladder vs. higher isovolumetic pressures for the strong bladder.
  • a method of assessing urinary tract function comprising:
  • Example measurement containers are described elsewhere herein.
  • the measurement container can be open to the exterior atmosphere, e.g., the interior of the measurement container can be in fluid communication with the exterior environment. Put another way, the measurement container need not be air-tight.
  • the measurement container can also be flexible and/or resilient such that introduction of fluid into the container need not also increase (or at least appreciably increase) the pressure within the measurement container.
  • Aspect 34 The method of Aspect 33, further comprising correlating at least one of (a) the weight or a change therein of the enclosed measurement container, (b) the weight or a change therein of the contents of the enclosed measurement container to a urinary flow rate, a bladder pressure, or any combination thereof.
  • Aspect 35 The method of any of Aspects 33-34, further comprising placing the conduit into fluid communication with the measurement container. This can be accomplished by connecting the conduit directly to the measurement container. This can also be accomplished by connecting the conduit to a device (e.g., a valve) that can in turn place the conduit into fluid communication with the measurement container. This can also be
  • Aspect 36 The method of Aspect 35, wherein the conduit is placed into fluid communication with the enclosed measurement container by way of a valve having two or more positions.
  • Aspect 37 The method of any of Aspects 33-36, further comprising at least partially interrupting fluid communication between the bladder of the patient and the enclosed measurement container. This can be accomplished by, e.g., closing a valve or by constricting a fluid pathway between the bladder of the patient and the measurement container.
  • Aspect 38 The method of any of Aspects 33-37, further comprising interrupting fluid communication between the conduit and the environment exterior to the conduit.
  • NUC noninvasive urethro-cystometer
  • the disclosed technology generates urodynamic information without catheterizing the bladder.
  • the NUC provides information about the strength of bladder contraction and the amount of urethral resistance to urine flow by dynamically probing lower urinary tract (LUT) function during urination.
  • LUT lower urinary tract
  • the disclosed technology can provide urine flow rate, total urine volume and urethral resistance to urine flow by simultaneously measuring LUT pressure and flow during urination. The resulting flow-pressure curves partial out the relative contribution of urethral obstruction versus bladder muscle weakness to decreased urine flow.
  • a leak proof seal can be established between the patient's urethra and the closed air space contained within the bottle. This connection can be established by connecting an indwelling catheter to the bottle, but can also be accomplished via a leak-proof seal between the tip of a patient's penis and the bottle.
  • the patient is instructed to urinate freely into the bottle, so that the entering urine compresses the air inside thereby generating a pressure-time curve.
  • Multiple pressure-time curves from within the bottle are recorded during the urination and analyzed to generate measures of urine flow and total urine volume (uroflowmetry).
  • Flow-pressure curves are derived from the pressure-time curves.
  • the flow-pressure curves are analyzed to generate measures of bladder strength and urethral obstruction during the urination (urodynamics).
  • FIG. 2 provides an illustration of an exemplary system.
  • a urethra can be placed into fluid connection (suitably leak-proof) with a closed air space within a container (not labeled).
  • the pressure within the container can be read using a pressure gauge.
  • the prostate can, depending on enlargement, constrict flow within the urethra. This can result in a weak urine stream, but without more information, a patient will not know if their urinary situation is being caused by an occluded urethra or by a weakened bladder.
  • system 20 may include connection between the urethra 203 (the prostate 202 is shown, along with urine 201 in bladder 200).
  • the penis can be in direct fluid communication with closed air space 205 (which can be a container); urine 206 is shown within closed air space 205.
  • a pressure gauge 207 may be in connection with the closed air space 205, allowing the user to monitor a pressure within the closed air space.
  • the NUC method for assessing bladder muscle strength is based on
  • vesical (bladder) pressure is the pressure created by contraction of the bladder muscle plus the intra-abdominal pressure.
  • the maximum bladder pressure can be determined by measuring the pressure within the urine-receiving container at which urine flow stops, otherwise known as the isovolumetric bladder pressure. This pressure can be determined by, e.g., increasing the pressure within the container so as to identify the pressure at which urine flow into the container stops.
  • the pressure within the container may be the sum of the vesical pressure and the applicable hydrostatic pressure.
  • the pressure measured in the container (also termed “bottle”) is equal to the sum of the vesical pressure (which consists of bladder muscle contraction pressure plus intraabdominal pressure) and hydrostatic pressure. The strength of bladder muscle contraction can then be calculated if the other quantities are known.
  • Intra-abdominal pressure can be measured by placing a pressure probe into the rectum.
  • IAP Intra-abdominal pressure
  • the IAP remains constant at about 20 mm Hg.
  • transients occur, they are evident as bumps in the NUC pressure-time curve that correlate with voluntary or involuntary straining.
  • catheterization is uncomfortable and carries the risk of seeding the bladder with bacteria, so patients are often pre-treated with antibiotics, still another avoidable risk.
  • Hydrostatic pressure is the pressure created by the height of the column of urine (water) from the surface of the urine in the bladder to the urethral opening or else the indwelling catheter opening into the closed air space (e.g., UED). This can be estimated using a common ruler, or else measured using an ultra-sonic bladder scanner to determine the exact level of urine in the bladder. This device is used on most hospital inpatient services to diagnose urine retention.
  • the urethra serves as a catheter.
  • Poiseuille's law for laminar flow can be used to extrapolate maximum bladder pressures and maximum urine flow rates without also needing to pressurize the closed air space within the bottle to high pressures.
  • Low pressure urodynamic measurements obviate the discomfort and risk of reflux caused by exposing the LUT to very high isovolumetric bladder pressures. These painfully high pressures can be generated during complete interruption of urine flow in a chronically obstructed patient with a strong hypertrophic bladder. This shown in the attached FIGs. 4-9, which provide representative flow- pressure curves to distinguish obstruction from contraction issues in LUTS.
  • urethral resistance is the relationship between urine flow into the bottle and the bottle pressure.
  • graphically, urethral resistance is the inverse slope of flow rate with respect to bottle pressure.
  • the disclosed technology can thus measure bladder muscle strength of contraction through a catheter. This is a convenient and noninvasive method to determine when an indwelling catheter should be removed or else replaced with a stent. [00174] Additional Theory
  • High back-pressure creates a risk for painful stretching of the distal urethra and also a risk for urine reflux (retrograde urine flow from bladder to kidney). These complications can be avoided by limiting the back-pressure to more modest levels (e.g., ⁇ 60 mm Hg) since the important physiological information about flow rate, bladder pressure, urethral resistance and urethral compliance can be derived from analysis of the initial low pressure segment of the backpressure curve (e.g., 0 mm Hg to 30 mm Hg).
  • a system can be programmed/operated to momentarily relieve the internal pressure each time that a specified back-pressure value is reached (e.g., 30 mm Hg), thereby generating multiple pressure-time curves that painlessly capture the dynamics of LUT function throughout urination.
  • a specified back-pressure value e.g. 30 mm Hg
  • FIG. 5 is a typical urination back-pressure record from a young adult male without LUTS, showing back-pressure plotted as a function of time. Values for urine volume and urine flow rate are derived from differentiation of the pressure-time waveform.
  • FIG. 6 is an urination back-pressure record from an elderly male subject with LUTS caused by bladder outlet obstruction. By comparison, this record shows a lower flow rate and decreased total voiding volume during the same time frame as the prior record.
  • the rate at which the back-pressure builds up in the enclosed air chamber is dependent upon two opposing factors: 1) flow generated by bladder muscle contraction (i.e., reflecting detrusor strength); and, 2) resistance to flow caused by urethral obstruction (e.g., reflecting degree of bladder outlet obstruction from enlarged prostate).
  • the disclosed technology determines the degree of both of these elements by analyzing the dynamic relationship of urine flow rate with respect to back- pressure within the enclosed air space, as seen in FIGs. 7 and 8.
  • Flow-pressure curves during the isovolumetric (maximum) portion of bladder contraction are graphed and analyzed within a portion of the curves showing laminar flow (e.g., 10 to 30 mm Hg).
  • laminar flow e.g. 10 to 30 mm Hg.
  • the linear relationship between flow and pressure resulting from laminar flow enables the extrapolation of maximum values of flow rate at zero back-pressure, and maximum (isovolumetric) bladder pressure at zero flow rate. Values for urethral resistance and compliance can also be calculated.
  • the normal subject's test results indicate a high flow rate (i.e., no obstruction) and normal bladder contraction (i.e. no detrusor weakness).
  • the obstructed subject exhibits less than half the normal subject's flow rate in addition to elevated bladder pressure.
  • FIG. 7 provides urinary flow rate vs. pressure for a healthy adult male, containing five curves which occur during the isovolumetric portion of bladder contraction in a typical urination. The curves are averaged to afford a linear trend line. Data: 27.45 ml/s max flow rate (Qmax), 92.05 mmHg max bladder pressure (Pmax), and urethral resistance corresponding to a slope of -0.2982.
  • FIG. 8 provides urinary flow rate vs. pressure for an obstructed elderly male. Two curves that occurred during isovolumetric bladder function were averaged to yield Qmax of 11.66 ml/s, Pmax of 104.7 mm Hg and urethral resistance
  • Qmax represents the maximum flow rate that occurs when back-pressure is zero, as when there is no opposing pressure within the enclosed space to impede urine flow.
  • maximum back-pressure Pmax occurs when the flow rate is zero, as when back-pressure within the enclosed space is equal to bladder pressure and thus blocks urine flow into the UED chamber.
  • the slope (m) of the linear trend line represents the degree of urethral obstruction (resistance) and can be used in conjunction with the other values (Qmax and Pmax) to determine the nature of a subject's lower urinary tract function. Tests can be performed using other back-pressure ranges, from as low as 30 mm Hg as seen in FIGs. 5 and 6, to as high as typical bladder pressures.
  • the choice of a high versus a low back-pressure range is primarily a tradeoff between increased accuracy of the extrapolation of bladder isovolumetric pressure versus patient comfort.
  • the disclosed technology does not require the urethra to be exposed to high back-pressures.
  • the urethra is not unduly stretched and can be used in lieu of a catheter to analyze LUT physiology.
  • the flow-pressure chart has several segments that reflect different LUT physiological components, and the individual flow-pressure curves can emulate the data generated during invasive cystometric testing. More specifically, the first flow-pressure curve records the onset of voluntary urination after the subject is attached to the system and therefore gives information about the initiation of bladder contraction; gradual or abrupt, smooth or stepwise, fast or slow, strong or weak, etc. The magnitude of the first curve can also indicate the presence of obstruction or urgency to urinate.
  • subsequent curves can show an initial transient urine "Gush" region (usually in the 0 to 10 mm Hg range) caused in part by expansion (i.e., stretching) of the urethra due to the mild back-pressure (e.g., 30 mm Hg) which is later followed by urethral contraction when the back-pressure is momentarily relieved.
  • Gush initial transient urine "Gush” region
  • the mild back-pressure e.g. 30 mm Hg
  • the initial portion of the flow-pressure curve permits estimation of urethral compliance from the magnitude and the slope of this segment of each flow-pressure curve.
  • a compliant ("stretchy") urethra has a Gush region with a low slope while a less compliant (“stiff') urethra can evidence a relatively higher slope under the same flow and back-pressure conditions.
  • the Gush region involves complex interactions of urethral and bladder elements, which will be discussed in greater depth in future publications;
  • a linear region follows each Gush region and provides data from which Qmax and Pmax can be derived by extrapolation, as well as information regarding the relationship of flow to pressure at any point on the flow-pressure curve.
  • the slope of this linear portion of the flow-pressure curve (which reflects laminar or quasi-laminar flow) provides a means to partial out the relative contribution of urethral flow resistance (due to obstruction) versus poor bladder contraction (due to detrusor weakness) as the source(s) of diminished urine flow rate.
  • FIG. 9 provides a flow v. pressure chart for both normal and obstructed subjects, showing both the Gush and the isovolumetric portions of the curves. These curves have a transient Gush region (0-10 mm Hg) from which urethral compliance can be deduced, and a linear region (10-30 mm Hg) from which flow rate, bladder pressure and urethral resistance can be determined.
  • FIG. 10 provides a depiction of an exemplary system according to the present disclosure.
  • conduit 1002 is in fluid communication with patient bladder 1000.
  • the conduit can be, e.g., an indwelling catheter, such as a Foley catheter.
  • Device 1004 can be used to modulate the communication of urine from patient bladder 1000 to measurement container 1006.
  • Device 1004 can be a valve, in some embodiments.
  • Device 1004 can be used, e.g., to divert urine flow to alternative conduit 1012, which can in turn lead to urine collection 1014.
  • Urine collection 1014 can be, e.g., a bag, a bedpan, and the like.
  • a system can include a pressure transducer 1008 that is configured to measure pressure within measurement container 1006, though pressure transducer 1008 is not a requirement.
  • a system can include a weighing device 1010 (e.g., a load cell) that is configured to determine the weight of measurement container 1006 and urine 1016 that can collect within measurement container 1006. The system can also be configured to "tare" so as to zero-out the weight of measurement container 1006 and to collect the weight of urine 1016 that can collect within measurement container 1006.
  • Measurement container 1006 can be air-tight and enclosed against the environment exterior to the container. This is not, however, a requirement, as measurement container 1006 can be "open” or in fluid communication with the environment exterior to the container.
  • a system can also include a device (e.g., a solenoid-driven valve) that allows for release of pressure from within measurement container 1006.
  • the release device can be automated, e.g., a valve that opens when the pressure within the measurement container reaches a certain predetermined value.
  • the release device can also be manually operated.
  • a system according to the present disclosure can also include a graphical user interface (GUI).
  • GUI graphical user interface
  • the GUI can be used to visualize information (e.g., urine weight vs. time) gathered by the system.
  • the GUI can also be used to control the system, e.g., to turn system power on or off.

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Abstract

L'invention concerne des systèmes de cathéter à demeure de diagnostic, et des procédés associés. Les systèmes de l'invention comprennent un cathéter à demeure en communication fluidique avec un récipient dont la pression et/ou le poids sont mesurés puis utilisés pour évaluer l'état des voies urinaires chez un patient.
PCT/US2018/031530 2017-05-08 2018-05-08 Systèmes de cathéter urinaire à demeure de diagnostic, et procédés associés WO2018208734A1 (fr)

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US20210330935A1 (en) * 2020-04-24 2021-10-28 Covidien Lp Catheter including one or more sensors
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CN114176552A (zh) * 2021-12-28 2022-03-15 中国人民解放军陆军特色医学中心 一种具有排气功能的腹腔压力测量装置
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CN115444425A (zh) * 2022-10-12 2022-12-09 绵阳美科电子设备有限责任公司 具有留置导尿排尿日志功能的医疗监护仪及应用方法

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