A LOW THERMAL CAPACITY DEVICE FOR HIGH PRECISION POCKET-SIZE SPIROMETRY AND OTHER APPLICATIONS

Abstract: It is disclosed a device based on active element(s) (1, 25) that can both monitor/measure and control the temperature of a given environment. Such element(s) are characterized by a low thermal capacity and are supplied power by means of a pulse width modulating technique. Monitoring is performed - on the same element(s) - by means of analysis of the temperature relaxation between heating pulses. The element(s) can be controlled to body temperature, thus resulting in a low-power, high-precision, pocket-size and light-weight instrument (pneumotacograph) suitable to perform accurate spirometry measurements. The device can be easily adapted for applications in high precision flow rate measurements and high sensitivity calorimetry as well.

Description: A LOW THERMAL CAPACITY DEVICE FOR HIGH PRECISION POCKET-SIZE SPIROMETRY AND OTHER APPLICATIONS Technical Field This invention refers to the fields of spirometry measurements and in particular to thermostatic control of pneumotacographs. Furthermore, it can also be conveniently used in both micro-calorimetry and in the measurement of flow rates of a fluid along a pipe. Background Art It is common practice to monitor lung function by analysing sample breath performance. As humans live breathing, it is easy to observe that our breaths are not all exactly the same and that even lung function may change depending on a wide range of variable factors. This is especially true in the case of particular environments or of special reactions to certain volatile or suspended agents, or of respiratory pathologies in progress. Lung volume is one of the most informative measurements that can be performed from the breath. Variations of volume allow estimating and predicting the profile of the lung functionality and are therefore crucial towards a proper and prompt treatment. Since lung volume is on the order of several liters, it is impractical to measure it directly. The flow can be measured instead - e.g. from the pressure drop across a resistance - and then integrated to obtain volume readings. This can be done reliably only to the extent in which the flow-measuring device is linear and accurate. Measuring flow instead of volume allows reducing the size and weight of spirometric devices. However, measuring flow entails a variety of technical problems mainly related to thermostatic regulation, which we examine below. In 1 925 A. Fleisch proposed what is still one of the most accurate methods to perform spirometry by means of measuring laminar flows. To that end, Fleisch used a honeycomb structure. The most common form of honeycomb structure consists of a cylinder made by coupling and rolling up two thin metal sheets, one corrugated and the other smooth, around a tiny hub. The metal sheets are made of brass and the dimensions of the resulting cylinder can be of diameter = 42 mm, height = 32 mm (Fleisch No. 4), the pressure drop is measured around the outer ring of the cylinder at a distance of 20 mm. The honeycomb structure is one of the many possible physical filters capable of maintaining a laminar flow in a conduit, so that pressure drop and flow rate values are linearly correlated. Following the Fleisch method, several other different structures have been introduced. The most widely known is that of the fine mesh screen structure. This is lighter than the honeycomb structure but "frequent cleaning and re-calibration are considered essential to preserve accuracy in measurements'^ ' ). The temperature of the air inside human lungs is 37°C and saturated with water vapor. When exhaled, air condenses and releases its vaporisation enthalpy. To maintain a temperature of 37°C, Fleisch and his successors chose to heat their structures by means of an external heater. As a matter of fact, the approximately 6.5 Watts required to heat a classical size 4 Fleisch cylinder, which is also due to heat inefficiency factors and to the high thermal inertia of the whole assembly, has up until recently made it difficult to produce a truly portable heated pneumotach system. As portable instruments cannot conceivably feature such high values of power consumption, in recent years several non-heated spirometry instruments and pneumotacographs have been proposed. One particularly serious difficulty that has arisen with the widespread use of non- heated flow transducers is vapor condensation. This factor slightly affects flow cooling, as condensing vapor releases its vaporisation enthalpy, though the main point is that turbulence occurs and this means that the flow is no longer linear. As turbulence implies a quadratic relationship between the pressure drop " and flow rate, flow readings can be seriously flawed. This source of error makes the non-heated systems unreliable in a very subtle way. N otes: 1 ) Office Spirometry. P.L Enright, R.E. Hyatt Lea & Febiger, 1 987 Spirometry is a test consisting of several repeated trials and for each trial condensing vapor releases its vaporisation enthalpy. After a small number of maneuvres referring to a single patient's test, the instrument tends to accumulate water vapor, hence the air flow becomes turbulent, and measurement overestimation increases. According to the rules suggested by the American Thoracic Society and the European Respiratory Society, the highest value achieved in a series of maneuvres has to be kept as the spirometry measurement result. So any overestimation error occurring during the test leads to globally wrong results. The recent increase of unreliable spirometric results is strongly related to the widespread use of non-heated pneumotach systems. Ceramic honeycombs had been introduced in an attempt to solve this problem, though without success, as these tended to absorb water vapor (2). They were also quite heavy and temperature had to be measured with extremely delicate, lightweight elements, besides creating difficulties in disinfecting. The present state-of-the-art provides a wide choice of solutions that exhibit technical drawbacks, which have heavily delayed the production of a simple, reliable, small, lightweight, low-power, easy-to-clean and truly portable pneumotach system. Similar problems also occur with those instruments which measure heat exchanges in physical (fluid flow rate measurement) and/or chemical processes especially in gas-solid interactions (Palladium-Hydrogen interaction). In fluid flow rate measurements, with constant direct measurement techniques, problems arise when flow rate changes rapidly and the fluid temperature is variable (e.g. like the case of blood flowing through a vessel (3)). On the other hand, techniques that separate the heat source (emitter) from the measuring device (sensor) have evident disadvantages in that the sensor collects only a small fraction of the signal emitted. Another case where thermostatic regulation is crucial is in the interaction Palladium-Hydrogen. In this case, the measurement concerns the enthalpy release 2 ) U.S. Patent Documents, 5.277.196 - 1 /1994 Hankinson et al. 1 28/725 3) Baxter Int. Inc., WO 94/28788 - 1 2/1994 accompanying the absorption of hydrogen into a Palladium layer and (on the basis of literature data) the determination of the amount of hydrogen absorbed by the sample ( 4 ). In this case, the calorimeter used to enclose the environment where the reaction takes place tends to be rather bulky, features a slow response and its cost is proportional to the precision to be achieved by the measurement. On the other hand, the use of micro-calorimeters built in accordance with micro- machining techniques exhibits difficulties relating to the small surface where the reaction takes place. There is a total lack of solutions in cases for which there is need for a large surface with a particularly low thermal inertia, and where the temperature sensor is integrated onto the surface without the surface limitations of micro-machining elements. Disclosure of Invention The purpose of this invention is to produce a device with at least one active element featuring low heat capacity, that may be used especially as a space-saving instrument for measuring and controlling heat exchanges. The invention refers to a device based on an active element of low heat capacity, capable of monitoring and controlling the temperature of a certain environment. Power is supplied to the active element by means of a pulse width modulating technique (PWM), while heat relaxation analysis between pulses is performed on the element itself. When it is set up for spirometry and calibrated for normal body temperatures, the device becomes a pocket-size instrument featuring high precision and low power consumption. With appropriate adaptations the same device may also be used either for high precision flow rate or high sensitivity calorimetry. Other unique features of this invention appear in the description that follows. 4) Lewis F.A., The Palladium Hydrogen System. Academic Press 1967 Detailed Description of the nvention Further on, a detailed description is provided with several examples of application and reference to enclosed figures. Enclosed illustrations: Figure 1 a honeycomb structure, built in accordance with the concept of this invention, obtained by rolling together two different foils. Figure 2 an electric circuit diagram, showing the microcontroller and a digital switch for heating the honeycomb structure shown in figure 1. Figure 3 represents the operating principle of the system, in accordance with the concept of this invention. Figure 4 shows the electric circuit diagram, with MOSFET transistors, which control the temperature of the honeycomb structure. Figure 5 shows the circuit used in the experiment for the reaction between Palladium and Hydrogen. Figure 6 shows a circuit for measuring flow rates. The preferred embodiment of the present invention comprises a substrate consisting a strip of stainless steel foil of 5-20 microns in thickness, shaped accordingly for the kind of application. This substrate is excited by means of a pulse width modulation power supply unit and measurements of temperature of the heater itself are performed during its thermal relaxation phase between adjacent pulses. Figure 1 shows a composite Fleisch honeycomb structure ( 1 ) made according to the concept of present invention. This consists of a structure obtained by rolling together two overlapping foils (2), (3), one of which is corrugated to obtain a honeycomb structure. One of the two foils is conductive (2) (i.e. made of stainless steel, from 0.01 to 0.05 mm in thickness, preferably 0.02 mm) and features a resistance value (2-3 Ohms with a temperature coefficient of some hundreds of microohms per °C) that makes it suitable for fast heating to the operating temperature by means of hand-held, low- power batteries. The other foil is a corrosion-proof insulator ( 3), capable of withstanding heat overloads up to 1 20 °C in order to allow thermal disinfection. Figure 2 shows an electrical circuit diagram representing the concept of this invention. This circuit is used to heat the Fleisch honeycomb structure shown in figure 1 as well as for other applications. It consists of a microcontroller (4), a bridge (5) with a heating/sensor element ( 6) on one branch and temperature- invariant resistors (7), (8) & (9) on the other branches, a switch ( 1 0) for connecting the power supply to the heating/sensor element (6) for the heating phase, a double switch ( 1 1 ) for supplying power to the bridge (5) for measuring thermal relaxation of the heating/sensor element itself (6) when the heating phase is not active, an instrumentation amplifier ( 1 2) for collecting bridge signals, which is then connected to the analog-digital converter ( 1 3) incorporated inside the microcontroller (4). Figure 3 provides a general description of how the system works. The digital power switch is turned on for 1 50 microseconds, whereas thermal relaxation of the element takes place for the remaining 850 microseconds of the duty cycle. During the 1 50 microseconds in which power is supplied, the element heats up. The temperature trend depends on the voltage and time. The time period of 1 50 microseconds can be increased or decreased depending on whether more or less heat is needed, whereas the 1 -millisecond time separation between pulses is maintained constant. At the end of the heating pulse the measuring phase begins. This consists of one or more measurements during the thermal relaxation. For example purposes, two measurements at the beginning and end of the relaxation phase (fig. 3) have been indicated. The microcontroller (4) issues a measurement pulse that is long enough to ensure stabilisation of the operational amplifier ( 1 2) for the measuring phase (i.e. 20 microseconds). At this time, the same pulse, delayed by the amplifier stabilisation time ( 1 2), is returned to the sample&hold circuit (S/H) of the 10- bit analog-digital converter ( 1 3) incorporated inside the microcontroller itself (4). The power supply to the bridge is switched off 10 microseconds after the S/H pulse which enabled the acquisition of the bridge amplifier signal. This supply period is kept short compared to the total relaxation time in order to reduce interference in the heating/sensor element. Figure 4 shows the electrical circuit diagram for temperature calibration of the Fleisch honeycomb structure. In this case, the digital switches are substituted by MOSFET transistors ( 1 9), (20). The Fleisch power supply works as if it were a switch as shown in fig. 2, whereas bridge power is supplied by means of a second MOSFET. A fast diode (21 ) situated at the top of the bridge facing towards the branch of the Fleisch structure completes the double switch function as it prevents the current from passing through the other branches of the bridge while the Fleisch structure (1 ) is in operation. A second fast diode (22) similar to the first is placed at the top of the bridge facing towards the other branch to ensure the same voltage drop in the two branches while the bridge is in operation. The amplifier gain value (23) is programmable. This can be increased when the signal is low and the 10-bit definition of the converter is unable to ensure sufficiently accurate measurements. The circuit in figure 5 is used in a calorimeter for the Palladium-Hydrogen interaction experiment. It has a solenoid valve which is used to introduce 200 mbar of hydrogen into the calorimeter. The bridge has two opposite branches (27, 28) that are activated with heating times which can differ, so that the bridge can be kept in balance as better clarified further on. The circuit shown in figure 6 is similar to that shown in figure 4 except for the reference element (26) which substitutes the temperature-invariant resistor in the bridge branch where the heating/sensor element is located, collects data regarding the fluid temperature and provides an output signal that is already filtered from the influence of temperature. As far as the Fleisch honeycomb filter in figure 1 is concerned, it is evident that the thermal inertia of the conductive sheet (2) is low (it weighs less than 10 grams) and enables fast heating to body temperature. Cold-start setting of the instrument can be performed within 30 seconds for a Fleisch No. 4 size structure, and temperature calibration can be stopped immediately after the test, as well as the related power supply, which can be reduced to its new lighter duties. The transducer is maintained free from condensed vapor, which is crucial towards rendering the measurement robust to environmental conditions (humidity) and indispensable during intensive testing (exhaled air is saturated with water vapor). In addition, it can be sterilized on the spot by heating it up to 1 20 °C for a few seconds, or removed for cleaning with disinfectants. Previous descriptions referring to the honeycomb filter can also be applied to the fine mesh screen in the same way, the only difference being that in this case there are wires instead of sheets. Another preferred embodiment that is suitable for performing high sensitivity calorimetric measurements (as indicated in figure 5) is described by the following experiment. The heating/sensor element has been enclosed in a reactive chamber equipped with inlet/outlet valves enabling either evacuation of the chamber or introduction of the selected gas. The sensor element consists of a 5-micron stainless steel foil. For this, taking into account a weight of 8 g/crτr and a specific thermal capacity of 0.1 cal/g referring 2 ? to a unit area of 1 cm , we have a thermal capacity ~ 400 μcal/°C cm . With reference to the same strip area heated at 60 °C (remembering that the exchange surface of the strip is two times the unit area), we have a thermal flow in ? ? Helium atmosphere at 25 °C of 2.4 mW/°C cm ^ 576 μcal/°C cm sec (giving a thermal flow through exchange surface for a 35 °C gradient equal to 20, 1 60 μcal/cm sec). The loss of radiation per cm , taking into account an emission factor for a polished surface of 4% is 5.67 x 1 0 " 1 2 x 0.04 x 333 4 ~ 27.89 x 1 0" 4 Wo - 669.31 / cal/cm 2 sec The heater/sensor temperature (solid-gas phase) is calibrated to 60°C by means of the PWM power supply and adopting a frequency range from 1 to 10 kHz and accepting a ripple less than 1 °C around the mean value of 60°C. With a Palladium-coated (0.1 micron) strip we obtain 0.1 2 mg/cm weight and 7 microcalories/°C cm thermal capacity. Once the steady state condition is reached, 200 mbar of hydrogen are introduced into the chamber and the sample temperature is monitored according to the described procedure. Since 0.1 2 mg of Palladium corresponds to 1 .1 2 x 10 " 6 mol and the hydrogen absorption enthalpy is ~ 9 kcai/mol, a measured enthalpy of 3000 microcalories makes it possible to estimate that the Pd coating has been converted in into Pd Hydride, represented by the stoichiometric formula Pd Ho.6- The rapidity of this process well suits the geometric features of the sample according to the approximated formula. (Pd thickness) 2 {cm} ( I xl O -5 ) 2 Diffusion time = = ~ 1 msec (Diff coeff.) {cm 2 sec " 1 } ~10 '7 This also describes the benefits introduced by the device, which is capable of monitoring even rapidly evolving processes. A further improvement in accuracy of the measurement can be achieved by using the device in a differential manner as indicated in fig. 5. Here two strips, one Pd coated (27) and one used as reference (28) are simultaneously connected to the PWM supply with independent circuits. The PWM frequency ranges from 1 to 10 kHz and thermal relaxation is measured twice at the beginning and at the end of the free thermal evolution of the element. The differential signal thus collected provides the heat variation on one branch of the bridge with high sensitivity. This technique can be even further improved by introducing a servo-loop and appropriate processing by the microcontroller. In this case, the duty cycle of the PWM supply to the Pd coated strip is continuously adjusted in order to maintain the bridge in equilibrium and the power differences between the two PWM supplies provides an immediate indication of the amount of heat exchanged. The proposed device is also particularly useful for application as versatile high precision flow meters. Heat loss by convection in a meter stream from a strip oriented along the direction of the fluid depends on the temperature gradient between the strip and the fluid, according to cys = h (t p | - tF) where Q = heat loss S = surface tp| tp = plate and fluid temperature h = heat loss coefficient Accepting on an empirical ground that for water flowing at a rate u (fluid velocity in cm/sec) below 200 cm/sec, h is given by h ~ 2.8 x 1 0 *6 u cal/°C cm 2 sec it is possible to determine that, within typical boundary conditions of tp| = 47°C, tF = 37°C fluid velocity from 1 to 100 cm/sec leads to a heat exchange rate ranging from 28 to 2,800 microcalories per millisecond per square cm. Such large heat exchange values provide a great flexibility in facing several different real world problems, by handling both PWM frequency and substrate dimension. The same technique works also for measuring blood velocity in vivo in blood vessels. The above calculation can obviously be simplified, by merely substituting one of the temperature-invariant resistors on the same side of the heated strip with an identical strip which plays a role only in the measurement process but not in the heating process, as shown in fig. 6. Reference Numbers in Figures 1 honeycomb structure (active element) 2 corrugated conductor foil 3 insulator foil 4 microcontroller 5 bridge for measurements (high precision resistor bridge) 6 heating/sensor element 7 temperature-invariant resistor 8 temperature-invariant resistor 9 temperature-invariant resistor 10 digital switch 1 1 double digital switch 1 2 signal amplifier 1 3 analog/digital converter 14 time delay device 1 5 delayed measurement pulse output 1 6 measurement pulse output 1 7 heating pulse output 18 Sample&hold input 19 MOSFET transistor 20 MOSFET transistor 1 diode 22 diode 23 signal amplifier 24 solenoid valve 25 active heating element (current measurement device) 26 reference element 27 active reference element. 28 active element for differential operation

Claims: Claims 1 ) A device, based on active element(s) ( 1 , 25) featuring low thermal capacity, capable of both monitoring and controlling the temperature of a given environment, said element(s) ( 1 , 25) being supplied power by means of pulse modulating technique to achieve a required temperature, the thermal relaxation between the pulses enabling to sample and to control the temperature of the given environment. 2 ) A device according to claim 1 ), the temperature of the active element(s) ( 1 , 25) and the temperature relaxation between modulated pulses being measured by comparing the electrical resistance of the active element(s) ( 1 , 25) to that of temperature-invariant resistors by bridge measurement techniques ( 5). 3 ) A device according to claims 1 ) and 2) used for spirometry measurements the inhaled and exhaled air being kept at body temperature, the heating/sensor element consisting of a composite honeycomb structure built according to Fleisch geometry, said structure being obtained by coupling insulating (3) and conductive (2) layers featuring appropriate electrical resistance characteristics. 4 ) A device according to claims 1 ) and 2), for measuring the flow rate of a fluid, the flow rate being measured by one or more appropriate sensor and control element(s) consisting of thin metal strip(s) supplied power by means of a pulse modulating circuit, and the flow rate being determined by measuring the thermal relaxation between the pulses of the circuit. 5 ) A device according to claims 1 ) and 2), adapted for calorimetric measurement of heat exchanges occurring in solid-gas reactions, the sensing element(s) consisting of metal sheet(s) featuring very low thermal capacity and coated with thin layers of the chosen solid, the elements being supplied power by means of a pulse modulating technique and the enthalpy of the chosen solid-gas reaction being determined by measuring the thermal relaxation between modulated pulses. 6) The overall assembly, comprising : - an element ( 1 ), consisting of several parallel channels, made of overlapping foils (2, 3) rolled up together, one of which (2) being knurled, corrugated or folded, the other being smooth, one of the foils (3) being an insulator and the other (2) being a conductor and featuring a resistance value that makes it suitable for rapid heating of the element (1 ) with adjustable operating temperature, using dry cell, low-capacity or rechargeable-type batteries, and - a circuit, wherein the element ( 1 ) is heated and calibrated to a determined operating temperature by means of a pulse modulating technique, the temperature of the element itself ( 1 ) and the thermal relaxation between the pulses of the circuit being measured by comparing the electrical resistance of the conductor foil (2) with that of temperature-invariant resistors by means of a bridge (5) measurement technique.

Inventors: TORRESIN GIUSEPPE, TORRESIN, GIUSEPPE
Applicants: BIOMEDIN SRL, TORRESIN GIUSEPPE, BIOMEDIN, TORRESIN, GIUSEPPE
Application year: 1997
Main classification: A61B5
IPC codes: A61B5, G01F1