FIELD OF THE INVENTION
The present invention relates to two methods for measuring urine flow, urine preferably being extracted from the bladder of a patient by means of a catheter.
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.
BACKGROUND OF THE INVENTION
Normally, 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. According to one embodiment of such a known arrangement, 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.
These kinds of arrangements do not provide a quick continuous measurement, requires considerable nurse capacity and further causes a large dead volume between the patient and the measuring device.
In certain cases there is a strong need to obtain an early indication of the urine flow. For example, when a patient turns into a state of shock, or an acute renal failure develops, there is a need for an early indication. The kidneys are very sensitive to lack of blood supply and may easily be damaged. This will compromise the fluid balance of the body since the kidneys control the fluid and electrolyte absorption need for a proper body fluid balance. The waste is discarded in the urine output. In a shock
state the urine output may be very low indicating that the kidney is not supplied with enough blood or that the fluid absorption is high. The urine production may also be very high due to a failing kidney that cannot concentrate the urine, with the potential risk of loosing both liquid and electrolytes which will endanger life. Patient under- going ventilatory treatment are known to retain fluid and are subjected for close follow up of urine production rate.
Attempts have also been made to measure the urine flow by sensor means. However, these arrangements are complicated and space-consuming and are attached to the bed of the patient and thereby require a large urine volume with less accuracy of the measurements.
Known from 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 aπanged 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. According to one embodiment, a flow sensor based on heat transfer is suggested, a sensor arrangement comprising two temperature-measuring sensors, and an intermediately located heater being suggested. According to other embodiments, sensors based on ultrasound, a turbine or pressure difference are suggested.
These known arrangements do still not provide a sufficiently short lag time and fast and continuous measurement over a short time period of the real urine production, especially at low production rates.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a method, a device and a sensor for measuring urine flow near the patient in order to eliminate problems related to large dead volumes.
A further object is to provide a sensor, which to a substantial part is disposable, i.e. a single patient arrangement.
These and other objects are obtained by means of a method, a device and a sensor as specified in the respective independent claims.
Preferred embodiments are specified in the corresponding dependent claims.
The features and advantages indicated above will be more fully understood from the following detailed description of the invention, taken together with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
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 and Fig. 6 is an example of a thermistor electrical chart.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
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.
In the tubing, preferably close to the urine outlet from the patient, a urine flow sensor 3 according to the present invention is arranged. The sensor is shown aπanged as a disconnectable part 4 of the total urine tubing and collection arrange- ment by means of end connection parts 4' and is in this case preferably arranged and intended to be disposable. Alternatively, the sensor may be provided integrated with the tubing, the sensor and the tubing to be provided as a unit. Signals from the sensor are taken out via leads 5 and transferred to a central unit CU comprising calibration data etc. and arranged for successive calculation of the urine production of the patient for e.g. patient monitoring and transfer to a patient information management system, this being indicated by an alarm bell 6 and a computer monitor 7.
According to a first embodiment of the sensor 3, Fig. 2, 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. According to another embodiment, shown in Fig. 2, a heating element 11 ' is arranged in the channel for direct electrical heating of urine in the channel.
Further according to the embodiment in Fig. 2, 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.
In order to obtain complete urine filling of the channel irrespective of the channel orientation and, thus, also complete filling at 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.
Furthermore, according to a preferred embodiment, 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. Preferably, the ventilation means are provided upstream as well as downstream of the pair of thermistors.
According to a second embodiment, Fig. 3, instead of two thermistors and heating means between them, a single thermistor 18 comprising heating means, i.e. a self- heated thermistor, is provided. By means of such an arrangement, each measurement is intended to comprise heating the thermistor by a heating pulse and following the temperature development by means of the thermistor. For this purpose, 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. Also according to this embodiment, unidirectional valves 16 and ventilation means 17 are preferably provided.
An important issue according to the invention is to reduce environmental influence on the predetermined results. For this purpose, the sensor, 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.
According to the embodiment of Fig. 4, a preferably metallic layer 21 with excellent thermal conductivity is applied between the sensor channel wall and the insulation layer 20. Of course, a layer 21 with good thermal conductivity may very well also be applied outside of the insulation layer.
According to the embodiments described so far, heating and substantially electrical heating have been used. However, it is also possible to obtain a well-defined and detectable temperature change pulse by means of cooling, and temperature changes may be obtained by other means than electrical. Thus, 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. Further, according to still another embodiment, a Peltier element is used to generate cooling pulses. Furthermore, in order to take care of heat generated by operation of such an element, it may be appropriate to operate the element as a cooling element for a first period of time and as a heating element for a second period of time, and so on.
According to yet another embodiment, extremely low detection levels, such as zero flow, may be detected, such flow could indicate zero kidney function, which is important medical information of another kind than urine production rate. For zero flow detection, 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.
As regards 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.
The function of the device and the sensor as well as the method according to the invention should to a considerable extent be apparent from the description given above.
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.
Further, a preferred important feature is that the sensor 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. According to preferred embodiments, the sensor may be provided to quite a low cost for fulfilment of criteria for disposability.
Furthermore, according to the basic inventive idea, 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".
By temperature change generating means at a predetermined spot, an increased or decreased temperature is introduced directly in the urine flow passing the predetermined spot. According to a preferred embodiment, an increased temperature is introduced in a self-heated thermistor, arranged at said spot for sensing the temperature development during and after heating. In the first case, 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.
The 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.
According to a first embodiment, Fig. 2, 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.
According to a second embodiment, 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. Thus, according to a first such embodiment, 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.
According to a second such embodiment, 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. Such an embodiment is illustrated in fig. 5, showing substantially one period of measurement. At ti, a square heating power pulse P is applied and ending at t2. This results in a temperature development detection curve S of the thermistor arcange- ment. At t3, the signal has nearly returned to a steady state level L. Thermistor signal S, i.e. deviation from steady state level L, integrated between t2 and t3, 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 t3 - 12 for the signal S to return to, nearly, the steady state level L does vary strongly with flow. Between t3 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 t2 - 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 t2 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.
L is, thus, redefined after the delay period, when the output signal of the thermistor has reached the steady state, ie before the start of the new period of measurement.
Furthermore, since 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.
As indicated above, there are a number of designs beside the preferred one illustrated in Fig. 5. Thus, e.g. the time for a predetermined thermistor temperature rise due to a predetermined applied heating pulse amplitude may be used as a measure of flow.
According to embodiments sometimes preferred and indicated above, 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. By adapting the effect to the flow, 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.
As is obvious from the description given above, the present invention offers impor- tant advantages compared to previously known technique. Thus, a quick and accu-
rate response to urine flow changes is obtained due to a very low "dead" volume. Further, 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.
The invention has been described above with reference to preferred embodiments. Of course, further embodiments as well as minor additions and amendments may be imagined without departing from the basic inventive idea.
Thus, although a thermistor concept seems very suitable for carrying out the present invention, other kinds of temperature measurement means and techniques, e.g. thermocouple techniques, may be used. Further thermistor alternatives are silicon semiconductor means and resistance wire, e.g. platinum, means changing their properties with temperature in a well-defined way.
Furthermore, the use of micro-fluidic chip sensor arrangements based on MEMS (Micro Electro Mechanical System) technology may be imagined for the present purposes.
As far as thermistors are concerned, an example of a 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.
Regarding patients in a ventilator (respirator), there are indications showing abdominal pressure, reflected by the pressure in the urine bladder, which could be used to optimize ventilator settings.
According to a prefeπed option, the body temperature of a patient is measured by measuring urine temperature, suitable measuring means being e.g. those discussed above. Thus, according to one embodiment, 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.
Above the invention has been applied for urine flow measurements. However, the invention may be applied for other flow measurements, a sensor according to the invention being used. Thus, 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.