WO2004100788A1 - Procedes, systeme, dispositif et detecteur de mesure du debit urinaire - Google Patents

Procedes, systeme, dispositif et detecteur de mesure du debit urinaire Download PDF

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Publication number
WO2004100788A1
WO2004100788A1 PCT/SE2003/000781 SE0300781W WO2004100788A1 WO 2004100788 A1 WO2004100788 A1 WO 2004100788A1 SE 0300781 W SE0300781 W SE 0300781W WO 2004100788 A1 WO2004100788 A1 WO 2004100788A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
urine
anyone
tubing
patient
Prior art date
Application number
PCT/SE2003/000781
Other languages
English (en)
Inventor
Per Wikefeldt
Brian HÖGMAN
Niko Petri Tarnanen
Original Assignee
Instrumentarium Corporation
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 Instrumentarium Corporation filed Critical Instrumentarium Corporation
Priority to AU2003241236A priority Critical patent/AU2003241236A1/en
Priority to PCT/SE2003/000781 priority patent/WO2004100788A1/fr
Publication of WO2004100788A1 publication Critical patent/WO2004100788A1/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
    • A61B5/201—Assessing renal or kidney functions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/68—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using thermal effects

Definitions

  • the invention further relates to an arrangement and a device for measuring urine flow from a patient.
  • the invention also relates to a sensor for measuring urine flow.
  • the urine production of a patient is measured by the urine output from the patient by means of a catheter and collecting the urine produced in a transparent plastic bag provided with a scale.
  • the volume collected is noted regularly over time and a mean production rate value may be calculated intermittently.
  • two alternative collecting chambers of different size are provided, one small chamber that can be emptied hourly into a larger chamber that holds the daily urine, in order to cover different production rates over time.
  • WO 01/60255 is an arrangement for a patient monitor comprising a sensor arranged between a patient urinary tract catheter and a urine collection con- tainer and a ⁇ anged to measure at least the flow or volume of the patient's urine output or the momentary urine flow and/or the volume cumulated in a unit of time.
  • a flow sensor based on heat transfer is suggested, a sensor arrangement comprising two temperature-measuring sensors, and an intermediately located heater being suggested.
  • sensors based on ultrasound, a turbine or pressure difference are suggested.
  • Fig. 1 is a schematically shown device according to the invention, comprising a urine flow sensor according to the invention,
  • Fig. 2 is a schematic sectional view of a first embodiment of a urine flow sensor according to the invention
  • Fig. 3 is a schematic sectional view of a second embodiment of a urine flow sensor according to the invention
  • Fig. 4 is a detail of a sensor according to said second embodiment
  • Fig. 5 is a sensor signal-applied power vs. time diagram for a sensor according to said second embodiment
  • Fig. 6 is an example of a thermistor electrical chart.
  • a tubing 1, Fig. 1 is arranged for taking out urine from a patient, not shown, the urine being intended to be collected in e.g. a plastic bag 2 and the tubing being con- nected to a urinary tract catheter arrangement or the like, not shown, leading urine out of the patient.
  • the urine flow through the tubing is intended to be taken as a measure of the urine production of the patient measured as volume/time, e.g. ml/s.
  • the sensor comprises a channel 8, through which urine from the patient is intended to flow, as indicated by arrow 8'.
  • the channel is preferably formed of a rigid channel wall material 9 and surrounded by a preferably concentric thermal insulating layer 10, a thermal shield.
  • Heating means 11 are arranged for heating urine at a predetermined spot 12 in the channel.
  • the heating means are arranged to generate successive heating pulses in order to obtain successive measurements. Heating may be achieved e.g. by means of induction heating, not shown, of a channel wall material element or of a separate element, arranged in the channel, by an induction coil, so that urine in the channel is heated by said elements, respectively.
  • induction heating not shown, of a channel wall material element or of a separate element, arranged in the channel, by an induction coil, so that urine in the channel is heated by said elements, respectively.
  • a heating element 11 ' is arranged in the channel for direct electrical heating of urine in the channel.
  • two thermistors 14, 15 are arranged in the channel for measuring the temperature development as a result of said heating, one 14 being located upstream of the predetermined spot and one 15 being located downstream of the predetermined spot.
  • a unidirectional valve 16 is preferably arranged in a downstream configuration of the predetermined spot, the valve preferably providing a certain forward flow resistance, preferably in combination with a threshold pressure arrangement (not shown). Preferably, such a valve 16 is also arranged upstream of said spot.
  • ventilation means 17, e.g. two membrane arrangements 17, e.g. one upstream and one downstream of said prede- termined spot, are provided, by means of which gas, such as air, in the urine is intended to escape.
  • gas such as air
  • the ventilation means are provided upstream as well as downstream of the pair of thermistors.
  • a single thermistor 18 comprising heating means, i.e. a self- heated thermistor, is provided.
  • each measurement is intended to comprise heating the thermistor by a heating pulse and following the temperature development by means of the thermistor.
  • the heat capacity of the thermistor is preferably low in order to obtain a quick cooling res- ponse, the thermistor being cooled by the urine as a function of the urine flow.
  • unidirectional valves 16 and ventilation means 17 are preferably provided.
  • the senor at least to a major part 19 covering the predetermined spot and the thermistor arrangement, is provided with a thermal shield, comprising a concentric insulation layer 20 in order to provide well- defined heating and temperature development conditions. Further, it is preferred to cover the sensor, at least said major part with a thermally conductive, preferably metallic layer 21, which, i.a., serves to even out the temperature profile along the sensor.
  • a preferably metallic layer 21 with excellent thermal conductivity is applied between the sensor channel wall and the insulation layer 20.
  • a layer 21 with good thermal conductivity may very well also be applied outside of the insulation layer.
  • heating and substantially electrical heating have been used.
  • a temperature change may be obtained by adding a liquid, e.g. water, to the urine, said liquid being hotter or colder than the urine in order to obtain a heating or cooling pulse, respectively.
  • a Peltier element is used to generate cooling pulses.
  • extremely low detection levels such as zero flow
  • flow could indicate zero kidney function, which is important medical information of another kind than urine production rate.
  • an embodiment with two thermistors and intermediately located heating means is preferred since the balance between the two thermistor signals may be used to indicate an extremely low or zero flow.
  • materials to be chosen for the different parts of a sensor according to the invention some examples are given below.
  • the ventilation means 17 may be made of a polyethylene sheet, heat-treated and fi- brous, e.g. TYVEK ® , made by du Pont, to be welded to the tubing.
  • the insulation layer 20 may be made of a cellular polymer, such as Frigolite.
  • the tubing may be made of polyethylene.
  • the metallic layer with excellent heat conductivity may be made of aluminium or an aluminium alloy.
  • a basic feature is that the sensor is applied near the patient so that the "dead vol- ume" between the patient and the sensor is kept very low.
  • the flow measured by the sensor will then give a correct picture of the flow produced by the patient and delay time in detecting urine flow transients, i.e. changes in patient urine production rate, will be kept very short.
  • the senor is disposable either separately, so that for a certain tubing the sensor may be exchanged, or together with a certain amount of the tubing, so that a sensor tubing kit may be exchanged.
  • the sensor may be provided to quite a low cost for fulfilment of criteria for disposability.
  • the flow measurements are based on a study of the urine temperature development after a temperature change generation pulse, introduced in the urine, where the change may be a positive one, i.e. a temperature increase pulse due to heating, or a negative one, i.e. a temperature de- crease pulse due to cooling. Therefore, when applicable, the description below is referring to "temperature change generation” instead of merely “heating”.
  • an increased or decreased temperature is introduced directly in the urine flow passing the predetermined spot.
  • an increased temperature is introduced in a self-heated thermistor, arranged at said spot for sensing the temperature development during and after heating.
  • the temperature development is sensed downstream of the predetermined spot by a thermistor, the tem- perature preferably also being sensed upstream of said spot by another thermistor as a reference.
  • connection between measured temperature development after a temperature change and the urine flow is determined by means of calibration, using known urine flows and temperature change generation conditions, and the corresponding connection or connections are registered and used in the central unit or the like to obtain a urine flow value for a measured temperature development.
  • each measurement comprises a temperature change pulse of a certain predetermined time duration, detection of a temperature change downstream of the predetermined spot and detection of the time between the temperature change generation pulse and the occurrence of said temperature change.
  • the flow is obtained from calibration data.
  • Fig. 2 the difference or ratio between two thermistor signals, one upstream and one downstream, is integrated during a predetermined time period after predetermined temperature change generation, the flow being obtained from calibration data.
  • Embodiments according to Fig. 3 may be performed in a corresponding way.
  • predetermined heating of the thermistor is performed and the time for obtaining a predetermined temperature drop is measured, the temperature development being measured by means of the thermistor and the flow being determined from calibration data.
  • the temperature development after predetermined heating is detected by the thermistor, and the output signal is integrated for a predetermined time period, the flow then being determined from calibration data.
  • a square heating power pulse P is applied and ending at t 2 .
  • the signal has nearly returned to a steady state level L.
  • Thermistor signal S i.e. deviation from steady state level L, integrated between t 2 and t 3 , is used to measure the flow and is calibrated against the flow.
  • Such an integral is useful over a wide range of flows, i.e. with a reasonably high signal to noise ratio at each flow. Said integral is expected to decrease monotonously with flow.
  • the length T of a measurement period is preferably allowed to vary with the flow since time t 3 - 1 2 for the signal S to return to, nearly, the steady state level L does vary strongly with flow. Between t 3 and T there is a predetermined delay period, typically 5 seconds, in order to make sure that the steady state level is arrived at before start of the next period.
  • the width t 2 - 1 of the heating power pulse is preferably predetermined for reasons of simplicity. If, however, necessary, e.g. if extra power would be necessary at high flows, the width, alternatively, may be automatically adjusted, so the thermistor temperature rise, compared to the steady state level, at t 2 is predetermined. Further according to preferred embodiments, the steady state level is individually defined for each period of measurement. The steady state level L corresponds to the temperature of the measured liquid (urine) and may therefore vary in time.
  • the steady state level L indicates the temperature of the liquid (urine)
  • L can be used to perform real-time temperature compensation of the measurement. Temperature compensation is needed as the measured signal varies with the temperature of the liquid.
  • a predetermined thermistor temperature rise due to a predetermined applied heating pulse amplitude may be used as a measure of flow.
  • more than one, i.e. several, temperature change generation energy and/or effect levels are available in order to conveniently cover a wide range of flow values, the background being that said energy transferred to the liquid per unit time and volume will decrease with increasing flow at a certain effect level.
  • an improved accuracy is normally obtained.
  • One way of doing this is to apply temperature change generation power continuously and adjust the power level in a control loop, so that the difference between, preferably filtered, thermistor signals upstream and downstream of the thermistors is maximized. The power level would then have to be calibrated against flow.
  • the present invention offers impor- tant advantages compared to previously known technique.
  • a quick and accu- rate response to urine flow changes is obtained due to a very low "dead” volume.
  • a broad urine flow interval may be covered by the measurements, e.g. from 2 ml/h to 2 1/h.
  • Measurements are performed in a "forgiving" way, especially when signal integration is employed, both with respect to flow and flow disturbances, e.g. in the form of gas bubbles, both heating and cooling "automatically” correct measurement qualitatively and quantitatively, so that a mean value taking into account both an increase and a decrease in the flow is obtained as the result of a measurement representing a certain measurement period T.
  • thermocouple techniques e.g. thermocouple techniques
  • silicon semiconductor means and resistance wire e.g. platinum, means changing their properties with temperature in a well-defined way.
  • micro-fluidic chip sensor arrangements based on MEMS (Micro Electro Mechanical System) technology may be imagined for the present purposes.
  • MEMS Micro Electro Mechanical System
  • thermistor for the present in- vention is a thermistor being provided by e.g. Thermometrics, Inc., USA, under the designation AB6E3.
  • Fig. 6 discloses an example of a thermistor electrical chart.
  • a ventilator respirator
  • abdominal pressure reflected by the pressure in the urine bladder, which could be used to optimize ventilator settings.
  • the body temperature of a patient is measured by measuring urine temperature, suitable measuring means being e.g. those discussed above.
  • a thermistor in the sensor channel is used for urine temperature measurement, preferably only at urine flow values above a certain level for a predetermined time, in order to avoid errors due to cooling, es- pecially dead volume cooling. Also, a correction for expected cooling is possible.
  • the invention has been applied for urine flow measurements.
  • the invention may be applied for other flow measurements, a sensor according to the invention being used.
  • the methods, the arrangement, the device and the sensor according to the invention may be used for measuring the flow of other liquids than urine, the source of the liquid not being a patient and the corresponding tubing, but some other source.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Fluid Mechanics (AREA)
  • General Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un procédé de mesure du débit urinaire d'un patient, l'urine du patient étant prélevée dans un système cathéter du tractus urinaire et un tube (1) connecté à ce système. Ce procédé consiste à placer un détecteur (3) dans ce tube pour déterminer le débit urinaire dans ce tube. Ce procédé se distingue par une étape de réduction du temps d'attente destiné à la détection des transitoires du débit urinaire par la réduction du volume d'urine entre le détecteur (3) et le patient en plaçant le détecteur à proximité de la sortie du système cathéter. L'invention concerne également un autre procédé, un système, un dispositif et un détecteur destiné à la mesure du débit urinaire.
PCT/SE2003/000781 2003-05-14 2003-05-14 Procedes, systeme, dispositif et detecteur de mesure du debit urinaire WO2004100788A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2003241236A AU2003241236A1 (en) 2003-05-14 2003-05-14 Methods, arrangement, device and sensor for urine flow measurement
PCT/SE2003/000781 WO2004100788A1 (fr) 2003-05-14 2003-05-14 Procedes, systeme, dispositif et detecteur de mesure du debit urinaire

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2003/000781 WO2004100788A1 (fr) 2003-05-14 2003-05-14 Procedes, systeme, dispositif et detecteur de mesure du debit urinaire

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WO2004100788A1 true WO2004100788A1 (fr) 2004-11-25

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Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102688045A (zh) * 2012-06-27 2012-09-26 上海理工大学 尿流量动态监视系统
EP2550036A1 (fr) * 2010-03-25 2013-01-30 Vasa Applied Technologies Ltd Procédé et ppareil pour déterminer les débits de fluides corporels excrétés ou secrétés
EP2567199A1 (fr) * 2010-05-03 2013-03-13 Renalsense Ltd. Débitmètre
DE102012201214A1 (de) * 2012-01-27 2013-08-01 Siemens Aktiengesellschaft Durchfluss-Sensor
CN103649693A (zh) * 2011-06-23 2014-03-19 瑞纳森斯有限公司 用于测量液体流速的方法和装置
WO2014176486A1 (fr) * 2013-04-26 2014-10-30 Serrano Eric Cathéter
US9021878B2 (en) 2009-05-08 2015-05-05 Renalsense Ltd. Flow rate meter
WO2015149191A1 (fr) * 2014-04-01 2015-10-08 Berlinger & Co. Ag Agencement de cathéter ou de canule avec capteur de débit et dispositifs, systèmes, utilisations et procédés associés
EP2780670A4 (fr) * 2011-11-17 2015-11-18 Univ Utah State Débitmètre à impulsion thermique
CN106691477A (zh) * 2017-02-28 2017-05-24 张家港市华美医疗器械有限公司 多点测压管及其使用方法
CN109805946A (zh) * 2019-02-27 2019-05-28 杨小华 一种应用尿道阻力测定判别下尿路梗阻程度的方法
WO2020069278A1 (fr) 2018-09-27 2020-04-02 Gauss Surgical, Inc. Systèmes et procédés de caractérisation de passage de fluide
WO2021216735A1 (fr) * 2020-04-24 2021-10-28 Covidien Lp Cathéter incluant un ou plusieurs capteurs
US20210330935A1 (en) * 2020-04-24 2021-10-28 Covidien Lp Catheter including one or more sensors
US11744498B2 (en) 2020-07-17 2023-09-05 Covidien Lp Catheter system

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4685470A (en) * 1984-11-21 1987-08-11 Terumo Kabushiki Kaisha Cardiac output measurement system and method
US5119674A (en) * 1988-05-06 1992-06-09 Nielsen Paul V Flowmeter
WO1995013016A1 (fr) * 1993-11-09 1995-05-18 Smiths Industries Public Limited Company Dispositifs de mesure de liquides
WO2000065313A1 (fr) * 1999-04-23 2000-11-02 Joergensen Thomas Friis Debitmetre
WO2002039071A1 (fr) * 2000-11-09 2002-05-16 Rosemount Aerospace, Inc. Procede et capteur de mesure de debit massique utilisant la conduction thermique de la sonde

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4685470A (en) * 1984-11-21 1987-08-11 Terumo Kabushiki Kaisha Cardiac output measurement system and method
US5119674A (en) * 1988-05-06 1992-06-09 Nielsen Paul V Flowmeter
WO1995013016A1 (fr) * 1993-11-09 1995-05-18 Smiths Industries Public Limited Company Dispositifs de mesure de liquides
WO2000065313A1 (fr) * 1999-04-23 2000-11-02 Joergensen Thomas Friis Debitmetre
WO2002039071A1 (fr) * 2000-11-09 2002-05-16 Rosemount Aerospace, Inc. Procede et capteur de mesure de debit massique utilisant la conduction thermique de la sonde

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9021878B2 (en) 2009-05-08 2015-05-05 Renalsense Ltd. Flow rate meter
EP2550036A1 (fr) * 2010-03-25 2013-01-30 Vasa Applied Technologies Ltd Procédé et ppareil pour déterminer les débits de fluides corporels excrétés ou secrétés
EP2550036A4 (fr) * 2010-03-25 2013-10-09 Vasa Applied Technologies Ltd Procédé et ppareil pour déterminer les débits de fluides corporels excrétés ou secrétés
EP2567199A1 (fr) * 2010-05-03 2013-03-13 Renalsense Ltd. Débitmètre
EP2567199A4 (fr) * 2010-05-03 2014-07-16 Renalsense Ltd Débitmètre
CN103649693B (zh) * 2011-06-23 2018-05-18 瑞纳森斯有限公司 用于测量液体流速的方法和装置
CN103649693A (zh) * 2011-06-23 2014-03-19 瑞纳森斯有限公司 用于测量液体流速的方法和装置
EP2724124A1 (fr) * 2011-06-23 2014-04-30 Renalsense Ltd. Procédé et appareil de mesure du débit d'un liquide
US9857210B2 (en) 2011-06-23 2018-01-02 Renal Sense Ltd. Method and apparatus for measuring the flow rate of a liquid
EP2724124A4 (fr) * 2011-06-23 2014-12-10 Renalsense Ltd Procédé et appareil de mesure du débit d'un liquide
EP2780670A4 (fr) * 2011-11-17 2015-11-18 Univ Utah State Débitmètre à impulsion thermique
DE102012201214A1 (de) * 2012-01-27 2013-08-01 Siemens Aktiengesellschaft Durchfluss-Sensor
CN102688045A (zh) * 2012-06-27 2012-09-26 上海理工大学 尿流量动态监视系统
WO2014176486A1 (fr) * 2013-04-26 2014-10-30 Serrano Eric Cathéter
WO2015149191A1 (fr) * 2014-04-01 2015-10-08 Berlinger & Co. Ag Agencement de cathéter ou de canule avec capteur de débit et dispositifs, systèmes, utilisations et procédés associés
CN106691477A (zh) * 2017-02-28 2017-05-24 张家港市华美医疗器械有限公司 多点测压管及其使用方法
WO2020069278A1 (fr) 2018-09-27 2020-04-02 Gauss Surgical, Inc. Systèmes et procédés de caractérisation de passage de fluide
CN113382677A (zh) * 2018-09-27 2021-09-10 高斯外科公司 用于管路流体表征的系统和方法
JP2022502653A (ja) * 2018-09-27 2022-01-11 ガウス サージカル, インコーポレイテッドGauss Surgical, Inc. インライン流体特徴付けシステムおよび方法
EP3856015A4 (fr) * 2018-09-27 2022-05-18 Gauss Surgical, Inc. Systèmes et procédés de caractérisation de passage de fluide
JP7470679B2 (ja) 2018-09-27 2024-04-18 ガウス サージカル，インコーポレイテッド インライン流体特徴付けシステムおよび方法
CN109805946A (zh) * 2019-02-27 2019-05-28 杨小华 一种应用尿道阻力测定判别下尿路梗阻程度的方法
WO2021216735A1 (fr) * 2020-04-24 2021-10-28 Covidien Lp Cathéter incluant un ou plusieurs capteurs
US20210330935A1 (en) * 2020-04-24 2021-10-28 Covidien Lp Catheter including one or more sensors
US11717642B2 (en) 2020-04-24 2023-08-08 Covidien Lp Catheter including one or more sensors
US11744498B2 (en) 2020-07-17 2023-09-05 Covidien Lp Catheter system

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