Abstract:
This invention relates to a measuring head which comprises an intake, an outlet, a mouthpiece and an electrically controlled proportional valve. The intake may be connected to a pressurized gas reservoir. The outlet releases exhaled gas and excess gas into the ambient. A mouthpiece provides gas to a subject and accepts exhaled gas from the subject. The electrically controlled, proportional valve is pneumatically connected between said intake and said mouthpiece for controlling the gas flow from said intake to said mouthpiece and said outlet. The invention urther relates to a method for controlling a gas flow from the intake to the outlet.

Description:
CROSS REFERENCE TO RELATED CO-PENDING APPLICATIONS  
       [0001]     This application claims the benefit of the European patent (EP) application number 05109390.4 filed on Oct. 10, 2005 and entitled MEASURING HEAD FOR DIAGNOSTIC INSTRUMENTS AND METHOD the content of which is expressly incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to pulmonary and cardiopulmonary diagnostic instruments and more specifically to measuring heads for such instruments and a method for controlling gas flow.  
       BACKGROUND OF THE INVENTION  
       [0003]     As described e. g. in http://www.med. unc.edu/wms/firstaid/FirstAid2/osy-RespNotes.DOC, available on the Internet site of the University of North Carolina, school of medicine, Whitehead Medical Society, First Aid for the first year, several parameters can be determined in order to describe the respiratory mechanics and gas exchange of a subject&#39;s lung: 
        FVC—forced vital capacity—total amount air exhaled     FEV 1 —amount of air exhaled during the first second of forced expiration     FRC—functional residual capacity     TLC—total lung capacity     RV—residual volume     IC—inspiratory capacity—amount of air inhaled above FRC;IC=TLC−FRC     ERV—expiratory reserve volume—amount of air exhaled below FRC; ERV=    FRC−RV        
 
         [0012]     FVC, FEV 1 , IC and ERV may be determined by spirometry. Process begins with patient breathing normally for several cycles. Normal breathing is represented by FRC—the lung volume at which the elastic forces of the lung are equally opposed by the outward pull of the chest wall. Tidal volume is the amount of air inhaled during normal breathing. Then the patient inhales to TLC and exhales forcefully to RV.  
         [0013]     FRC may be determined by (whole body) Plethysmography, Helium dilution or Nitrogen washout technique, which are described e. g. in “Respiratory Mechanics in Infants: Physiologic Evaluation in Health and Disease”, by a joint committee of the ATS Assembly on Pediatrics and the ERS Paediatrics Assembly, American Review of Respiratory Disease Vol. 147, 1993, p. 475-496.  
         [0014]     The nitrogen washout technique is to measure the volume of nitrogen washed out of the lungs when subject rebreathes from a reservoir of nitrogen-free gas. In the original studies the equipment used was fairly simple yet cumbersome to operate, later real-time techniques relied on mass spectrometers, which are technically demanding to maintain. If the amount of washed out nitrogen is measured and the initial concentration of alveolar nitrogen is known, then the lung volume at which the washout started can be derived. If washout starts at FRC, then FRC equals the volume of nitrogen washed out divided by the initial nitrogen concentration in the lungs.  
         [0015]     The difficult aspect of this technique is the accurate measurement of the volume of nitrogen washed out. In the two most commonly used methods, the volume of nitrogen is either measured from the expired gas in a collection bag or obtained by continuous integration of nitrogen concentration in the expired gas.  
         [0016]     In the expired gas collection method, the expired nitrogen volume is calculated as the product of the nitrogen concentration and the bag volume. Any inaccuracy in the measurement of the bag volume or, more commonly, the final nitrogen washout concentration, will cause significant errors. Because the final nitrogen concentration is very low, having been diluted with large amounts of oxygen, an error of &lt;1% in its measurement will cause substantial error. The resolution, and thus the accuracy, of the method depends on the initial alveolar nitrogen concentration.  
         [0017]     Using rapidly responding gas analyzers (or mass spectrometers) to obtain instantaneous nitrogen concentration and a computer to integrate flow signals, an open circuit system can be created. The expired volume and the associated nitrogen concentration are measured continuously by fast response gas analysers or mass spectrometers. A variation of this technique used a constant bias flow, higher than the peak inspiratory flow. This bias flow diluted the expiratory nitrogen concentration and resulted in similar accuracy problems as the collection bag systems.  
         [0018]     Furthermore the large continuous bias flow consumed large amounts of oxygen gas, increasing the cost of the test.  
         [0019]     Other potential problems with the nitrogen washout technique include those associated with analyzer response time, lag time between flow rate and gas concentration, and sampling rate.  
         [0020]     Corrections must be made for the nitrogen flushed from the tissues and blood. The latter usually causes &lt;5% error within a typical washout period of 2 to 3 minutes but may be larger if washout is prolonged in patients with lung disease. In the usual adult methods, end-tidal nitrogen concentration is measured continuously and required to decrease to &lt;2%, because concentrations higher than 2% tend to overlook the effects of extremely slow spaces. Final nitrogen concentrations of &lt;1% tend to exaggerate the effect of normal nitrogen diffusion from pulmonary blood to the alveolar space. In some methods the final concentration is derived from exponential analysis of only a few breaths.  
         [0021]     As with all gas dilution techniques, results may be invalidated by leaks.  
         [0022]     Further, it is clinically useful (cf. osy-RespNotes.DOC, I.c.) to measure diffusing capacity for carbon monoxide (D L CO). Lung has a large surface area for gas diffusion of about the size of a tennis court and diffusion barrier is very small (0.1 Mm -1.0 Mm). CO is used because its uptake rate is limited only by diffusion process even in the normal lung. However, patients with low hemoglobin levels will have falsely low D L CO and a correction factor is used. Diseases that affect thickness of diffusing surface (emphysema, interstitial fibrosis) are notable for low D L CO. Diffusion capacity for CO=volume of CO transferred in milliliters/minute per mmHg of alveolar gas pressure D L CO=V CO /P A CO; V CO  is the rate of CO uptake and a measure difference between known concentrations inhaled and amount exhaled after 10 seconds.  
         [0023]     In all washout, dilution or diffusion techniques it is important that subject breathes a gas with well-defined composition and is able to exhale gas for immediate analysis or storage and delayed analysis. The inspiratory gas flow control may be performed by so-called demand valves. Compared to inspiratory bag solutions, they offer reduced gas consumption, less potential for inspiratory gas composition deviations due to leaks and easier handling.  
         [0024]     Mechanical embodiments of demand valves are also used for diving or resuscitator equipment. In typical mechanical demand valves, the breathing of the subject causes a pressure difference which bends a membrane. The bent membrane opens a valve to a pressurized air or oxygen reservoir. From the pressure difference and the gas flow through the valve a flow resistance may be calculated. A high flow resistance reduces compliance of subjects with necessary maneuvers for washout, dilution or diffusion techniques.  
         [0025]     The pressure drop in a tube can be calculated from the following formula (Technische Strömungsmechanik 1, VEB Deutscher Verlag für Grundstoffindustrie, Leipzig):  
               Δ   ⁢           ⁢   p     =       ξ   ⁢     ρ   2     ⁢     v   a       =           λ   ⁢           ⁢   I     d     ·     ρ   2       ⁢     v   a                 (   1   )             
 
         [0026]     Δp thereby is the pressure dropping in the tube, ξ is a pressure loss correction value of the tube, λ is a pipe friction value of the tube, | is the length of the tube, d is the diameter of the tube, ρ is the density of the flowing medium, i.e. approximately 1.2 kg/m 3  for air, and v is the flow velocity averaged over the cross-section. a has the value 2 for turbulent flows and 1 for laminar flows. In practice a may also adopt intermediate values, as an ideal-typical form of flow is rare. Equation (1) is also known from Strömungslehre, J. H. Spurk, 4 th  Edition, Springerverlag, Berlin 1996, wherein λ here is called the flow resistance coefficient. The averaged flow velocity is connected with the air flow {dot over (V)} as follows:
 
{dot over (V)} =v ·π( d /2) 2   (2)
 
         [0027]     V itself stands for an air volume. The point designates the derivative with respect to time d/dt.  
         [0028]     If one inserts (2) in (1), one obtains the following quadratic dependence of the pressure drop Δp on {dot over (V)}. The dependencies of λ, |, d and p were combined to the constant C, with C being a parameter for the used tube:
 
Δ p=C ·{dot over (V)} a   (3)
 
{dot over (V)}= C′Δp   1/a   (4)
 
         [0029]     Equation (4) is equivalent to equation (3), but solved for {dot over (V)}.  
         [0030]     The WO 98/31282 A1 corresponding to U.S. 2002/0185126 A 1  and DE 197 46742 A1, discloses a controlled gas-supply system. Gas sources provide 02, NO, N 2  He or CO 2  under an excess pressure. The flow of each gas source is controlled by a valve, which may in turn be controlled by a pressure sensor close to the nose of a patient. The pressure drop at the beginning of the inspiration may be used as a trigger signal for a valve control.  
         [0031]     It is desirable to provide a measuring head and a method for controlling gas flow that combine increased subject&#39;s comfort with moderate gas consumption.  
       SUMMARY OF THE INVENTION  
       [0032]     According to an embodiment of the invention a measuring head comprises an intake, an outlet, a mouthpiece and an electrically controlled, proportional valve. The intake is connected to a pressurized gas reservoir. The outlet releases exhaled gas and excess gas into the ambient. The mouthpiece provides gas to a subject and accepts exhaled gas from the subject. The mouthpiece is pneumatically connected to the outlet. The proportional valve is pneumatically connected between the intake and the mouthpiece and controls the gas flow from the intake to the mouthpiece and the outlet.  
         [0033]     According to another embodiment of the invention a method for controlling a gas flow from an intake to an outlet and a mouthpiece by a measuring head is provided. The method comprises generating an electrical signal which has a monotonic dependence from the gas flow caused by inhaling of a subject. Further an opening of a proportional valve between the intake and the outlet and the mouthpiece is controlled by the signal. The gas flow caused by inhaling is compensated.  
         [0034]     A flow sensor advantageously may serve two purposes at the same time: determine the volume of the inhaled or exhaled gas and optimizing the position of the electrically controlled proportional valve.  
         [0035]     A measuring head comprising a flow sensor for measuring the gas flow through a mouthpiece facilitates the calibration of the proportional valve. The additional hardware is limited to a cap or shutter for closing the outlet.  
         [0036]     Also a differential pressure sensor may ensure that subject breathes a well-defined gas mixture only. Pressure sensors are less expensive than flow sensors.  
         [0037]     An array of on/off solenoid valves may be less expensive than a proportional valve.  
         [0038]     Setting the ratio of the flows through two open solenoid valves to a power of two advantageously minimizes the number of solenoid valves for a given ratio of maximum flow divided by flow step size.  
         [0039]     The signal of a pressure sensor which measures the pressure at a position between the intake and the proportional valve advantageously enables a balancing of pressure variations at the intake. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0040]     This invention can be more fully understood from the following detailed description when taken in conjunction with the accompanying drawings, in which:  
         [0041]      FIG. 1  shows a first embodiment of a pulmonary diagnostic instrument according to the invention;  
         [0042]      FIG. 2  shows a second embodiment of a pulmonary diagnostic instrument according to the invention; and  FIG. 3  shows a characteristic of a digital proportional valve.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0043]     While the present invention is described with reference to the embodiments as illustrated in the following detailed description as well as in the drawings, it should be understood that the following detailed description as well as the drawings are not intended to limit the present invention to the particular illustrative embodiments disclosed, but rather the described illustrative embodiments merely exemplify the various aspects of the present invention, the scope of which is defined by the appended claims.  
         [0044]      FIG. 1  shows a first embodiment of a pulmonary diagnostic instrument. A measuring head  1  controls the gas flow from a pressurized gas reservoir to a subject  2 . The pressurized gas reservoir may consist of one cylinder  4  or on an array of cylinders. A single cylinder may be mechanically attached to the diagnostic instrument and connected by a tube to connector  14 , which constitutes an intake or measuring head  1 . However, the tube shown in  FIG. 1  is meant to represent a hospital gas supply  15 . A pressure reducer reduces the pressure of 5 to 200 bar within the cylinder to about 4 bar (58 psl) within the hospital gas supply  15 .  
         [0045]     The gas flow from connector  14  to an outlet  21  and a mouthpiece in 19 is controlled by a proportional valve  10 .  FIG. 1  shows a digital embodiment of proportional valve  10  which comprises three on/off solenoid valves  11 ,  12  and  13 . Solenoid  20  valves are also referred to as magnetic valves. The flow through the solenoid valves  11 ,  12  and  13  may be adjusted by the length and thickness of the connection tubes and approximately calculated from equations (1) and (2). The gas flow depending on the pressure at connector  14  and the state of the solenoid valves is illustrated in  FIG. 3 . The connection tubes shown in  FIG. 1  to solenoid valves  13 ,  12  and  11  are short and thick, longer and thick, and longest and thin, respectively. The target values of the flow ratios of the flows through valves  12  and  11  and valves  13  and  12  are  2 . Since the relationship between flow and pressure difference is non-linear (confer equation (3)), the ratios may be set exactly to 2 only for a specified pressure difference e. g. 4 bar. On the other hand, edges may have a big influence on the 30 flow. Consequently the actual flow values should be calibrated by a method which is explained in more detail in connection with  FIG. 2 .  
         [0046]     A flow sensor  16  measures the correctly signed gas flow of gas inhaled and exhaled by the subject  2 . A mouthpiece top  20  may be provided in order to avoid direct contact between the subject  2  and the mouthpiece  19 . The mouthpiece top  20  may be easily detached sterilized. By integrating the signal of flow sensor  16  over time, the volume of inhaled and exhaled air is determined.  
         [0047]     For Helium dilution and Nitrogen washout technique and diffusing capacity measurement using CO, the exhaled gas must be analyzed. This is illustrated by gas sensor  17 . Gas sensor  17  may be a mass spectrometer connected by a capillary  26  to the junction  25  between outlet and mouthpiece or an array of gas sensors. As illustrated in  FIG. 1 , a mass spectrometer may determine the concentrations (c) of He, N 2 , CO, CO 2  and O 2 . In case of the nitrogen washout technique, an O 2  and a CO 2  sensor may be used. The nitrogen concentration and the concentration of other inert gases is the difference to 100%. The O 2  and CO 2  concentrations may be also measured during inspiration either for recalibrating the gas sensors, leak detection or verifying minimum gas flow.  
         [0048]     During breathing maneuvers of subject  2  the gas flow delivered by proportional valve  10  must be higher than the inspired gas flow. The excess gas flows into the ambient  5  through outlet  21 . This is the only way to guarantee that subject  2  inspires a well-defined gas mixture. The short tube between junction  25  and outlet  21  which is about 5 cm long, ensures proper gas flow and prevents back diffusion of ambient air. An additional flow sensor  24  may be provided in order to verify an excess gas flow into the ambient. Flow sensor  24  may measure only the absolute value of the gas flow. A drop of the gas flow below a threshold slightly above 0 indicates a possibly wrong measurement.  
         [0049]     If the pressure at connector  14  and the characteristic (confer  FIG. 3 ) of digital proportional valve  10  is known, the flow through valve  10  may be calculated. The proportional valve  10  is opened in order to ensure a minimum excess gas flow through outlet  21  into the ambient  5  throughout breathing maneuvers. This means that the proportional valve  10  is set that the calculated flow through the proportional valve  10  is higher than the inspiratory gas flow measured by flow sensor  16  plus a minimum excess flow. If flow sensor  24  is provided, the proportional valve  10  may be set that the flow measured by flow sensor  24  does not drop below a threshold.  
         [0050]     Alternatively or in addition to flow sensors  16  and  24  a differential pressure sensor may be provided. Differential pressure sensor  27  measures the pressure difference between the pressure at junction  25  and the pressure of the ambient air and provides the measurement result to computer  3 . The solenoid valves  11 ,  12  and  13  may be controlled that the pressure at junction  25  exceeds the ambient air pressure by a predetermined value which is greater than or equal to zero. This ensures that the subject  2  inspires a well-defined gas mixture. In the absence of flow sensors  16  and  24  a collection bag may be connected to outlet  21  in order to collect the expired gas and determine its volume and composition.  
         [0051]     If the pressure at connector  14  is reasonably constant, there is no need to measure this pressure. However, depending on the flow through the hospital gas supply  15  and the pressure reducer, the pressure provided by the hospital gas supply may easy drop by 30%. In order to allow for such pressure variations pressure sensor  18  is provided.  
         [0052]     All components shown in  FIG. 1  are either read out or controlled by computer  3 , which provides a easy-to-use user interface. Consequently it is no problem to handle two-dimensional, nonlinear proportional valve characteristics.  
         [0053]      FIG. 2  shows a second embodiment of the invention, which is slightly different from the first embodiment. The digital proportional valve  10  is replaced by a conventional (analog) proportional valve  22 . The advantage of a conventional proportional valve  22  is that the excess gas flow can be controlled more accurately. The disadvantage is its higher price.  
         [0054]     In addition to the elements shown in  FIG. 1 , a shutter  23  and a shutter driver  28  are shown in  FIG. 2 . The shutter driver  28  is controlled by computer  3 . In case differential pressure sensor  28  measures a pressure difference lower than a threshold, which is caused by inspiration of the subject, computer  3  has the shutter  23  closed by the shutter driver  28 . During the expiration phase the shutter is re-opened. The threshold is chosen close to zero.  
         [0055]     The closing of the shutter  23  during inspiration most reliably prevents the subject from breathing ambient air which devaluates the measurement. The shutter  23  even prevents diffusion. In order to further improve the measurement quality, the threshold may be chosen slightly negative. Alternatively, in order to increase subject comfort and compliance, the threshold may be chosen slightly positive. In order to improve time behavior, the time derivative of the differential pressure may be weighted by a factor and be added to the differential pressure before comparing the result to the threshold.  
         [0056]     A shutter may also be used in connection with a digital proportional valve  10 . However, this digital proportional valve should have a higher resolution than approximately ⅛ of the maximum flow, which is the resolution the valve  10  shown in  FIG. 1 .  
         [0057]     Moreover,  FIG. 2  illustrates the calibration of proportional valve  22 , which is also applicable to digital proportional valve  10 . Shutter  23  closes outlet  21  during calibration. Consequently, flow sensor  16  measures the gas flow through proportional valve  22 . The gas flow is measured at different positions of proportional valve  22  resulting in a one-dimensional characteristic.  
         [0058]     In order to take pressure variations at connector  14  into consideration, the gas flow through proportional valve  22  maybe measured at different pressures at connector  14 . This is illustrated by control line  32  to the pressure reducer of cylinder  4 . In another embodiment, the pressure reducer may be operated manually and a key may be depressed after a new pressure has been set. This results in a two-dimensional flow characteristic as shown in  FIG. 3 .  
         [0059]     Just for the purpose of calibration, the shutter  23  may be replaced by a simple cap that is mounted manually during calibration.  
         [0060]      FIG. 3  shows a simulation of a flow characteristic of a digital proportional valve  10  based on equation (4). The measurement points are marked by triangles, squares and diamonds. The pressure has been varied from 2 to 5.5 bars in 0.5 bar steps. Line  1  interpolates the diamonds representing the flow through solenoid valve  11  while valves  12  and  13  are closed. Line  2  interpolates the squares representing the flow through solenoid valve  12  while valves  11  and  13  are closed. Line  4  interpolates the triangles representing the flow through solenoid valve  13  while valves  11  and  12  are closed. The following constants were used for the stimulation:  
                                                                                       line/valve                1   2   4                            C′   0.22   0.396   0.704           A   1.7   1.5   1.3                        
         [0061]     The lines designated by 1+2, 4+1, 4+2 and 4+2+1 have been obtained by adding the gas flows of lines  1 ,  2  and/or  4 . The lines of the graph have the same order as lines in the legend. In a real embodiment, only lines  1 ,  2  and  4  may be measured. In an alternate embodiment all seven lines corresponding to all valve combinations in which at least one valve is open maybe measured.  
         [0062]     The maximum flow reaches 3.5 I/s at 4 bar. Line  41  represents a real pressure measured by pressure sensor  18  which is 3.8 bar. Line  42  represents the flow measured by flow sensor  16 , which is approximately 1.2 I/s. Under these circumstances computer  3  will open valves  11  and  12 , which will result in a flow  43  of 1.45 I/s on line  1 + 2 . Consequently, the excess flow will be 0.25 I/s  
         [0063]     If, as in this example, pressure values do not exactly match measured values, well-known interpolation algorithms may be performed by computer  3 .  
         [0064]     Skilled persons will appreciate that a similar characteristic can be obtained for a conventional analog proportional valve  22 .  
         [0065]     Further modifications and variations of the present invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the present invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred embodiments.  
       REFERENCE LIST  
       [0000]    
       
           1  measuring head  
           2  subject  
           3  computer  
           4  cylinder  
           5  ambient  
           10  proportional valve  
           11 ,  12 ,  13  on/off solenoid valves  
           14  connector/intake  
           15  hospital gas supply  
           16  flow sensor  
           17  gas sensor  
           18  pressure sensor  
           19  mouthpiece  
           20  mouthpiece top  
           21  outlet  
           22  proportional valve  
           23  shutter  
           24  flow sensor  
           25  junction  
           26  capillary  
           27  differential pressure sensor  
           28  shutter driver  
           31  measuring head  
           32  line  
           40  two-dimensional gas flow array  
           41  inlet pressure  
           42  inspiratory flow  
           43  estimated gas flow