WO2008093263A2

WO2008093263A2 - Breath analysis device

Info

Publication number: WO2008093263A2
Application number: PCT/IB2008/050253
Authority: WO
Inventors: Teunis J. Vink; Hans W. Van Kesteren; Nicolaas P. Willard
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2007-01-30
Filing date: 2008-01-24
Publication date: 2008-08-07
Also published as: WO2008093263A3

Abstract

A breath analysis device (10) comprising an inlet (11) for receiving a breath of a user, an analyzer (12) for determining a concentration of at least one element in the breath and output (15) for indicating the health zone corresponding to the concentration. The device also comprises a database for comprising previously determined concentrations and corresponding times at which the previously determined concentrations have been stored in the database and a processor (14) for storing in the concentrations in the database, comparing a measured concentration to at least one threshold for determining a health zone and recalculating the at least one threshold, based on the concentration and at least one of the previously determined concentrations.

Description

Breath analysis device

TECHNICAL FIELD OF THE INVENTION

The invention relates to a breath analysis device comprising an inlet for receiving a breath of a user, an analyzer for determining a concentration of at least one element in the breath, a processor for storing the concentration and comparing the concentration to at least one threshold for determining a health zone corresponding to the concentration and an output for indicating the health zone.

The invention also relates to a method for analyzing a breath.

BACKGROUND OF THE INVENTION Such a breath analysis device is known from the international patent application published as WO2005/025417. The application describes a method for analysis of respiratory conditions using exhaled nitric oxide (eNO) readings and for allowing precise titration of medication. The eNO values are compared to predetermined ranges or thresholds, for relating the measured eNO values to a "normal" "under control" and an "elevated" level. The patient's medication dose is adjusted in response to trends in the measured eNO levels. A trend is identified when a measured eNO level differs from the previous measured level. If the eNO level is too high, the patient is advised to consult a physician. The measured data may be uploaded to a clinician using the Internet.

SUMMARY OF THE INVENTION

It is a problem of the breath analysis device according to WO 2005/025417 that the relations between eNO levels and health risks are individual dependent and may change over time. Using predetermined thresholds may therefore result in wrong health related advices. It is an object of the current invention to provide a breath analysis device that provides more reliable health related advices. This object is achieved with a breath analysis device comprising an inlet for receiving a breath of a user, an analyzer for determining a concentration of at least one element in the breath, a database for comprising previously determined concentrations and corresponding times at which the previously determined concentrations have been stored in the database, a processor for storing in the database, the concentration and a corresponding time at which the concentration is stored, comparing the concentration to at least one threshold for determining a health zone corresponding to the concentration and recalculating the at least one threshold, based on the concentration and at least one of the previously determined concentrations and an output for indicating the health zone.

By storing the measured concentration and the corresponding times at which the concentration is determined in the database together with the already stored previously determined concentrations, a personal history of the concentrations of the exhaled element is created. From this personal history, the ranges between which the exhaled element concentration is, e.g., safe, lightly elevated, troubling or even alarming are determined. Using the most recent measurement as well as earlier stored measurements, the thresholds defining the ranges are recalculated. Consequently, the device, when used, is automatically fine-tuned to the personal situation of the user and is able to adapt to changes over time. The thresholds are updated according to the most recent measurements and the indicated health zones are adjusted to recent personal circumstances of the user.

Preferably, the output is adapted to show at least two different colors, each color corresponding to a different health zone. A green light may, e.g., indicate safe concentrations and a red light may indicate dangerous conditions. In a special traffic light like embodiment a third yellow or orange color may be used for indicating significantly elevated concentrations while the red light indicates that the concentration of the element concerned is so high that some kind of action is to be taken and the green light indicates stable conditions. Actions to be taken when in the red health zone may include, changing medication, increasing the frequency of checking the concentrations, consulting a doctor, cancel planned sport activities and much more. The use of the traffic light ensures a quick and very clear indication for the user of the health zone determined by the processor. Other color codes may also be used and will also be recognized quickly. However, the use of a traffic light is preferable because the colors of a traffic light are automatically associated with 'safe', 'moderate risk' and 'high risk'. In an embodiment of the breath analysis device according to the invention, the processor is further operative to calculate an advised time for analyzing a next breath, using the concentration and at least one of the previously determined concentrations. When the concentration has been in the safe zone for a longer period, it may not be necessary to keep on measuring the concentration, e.g., five times a day. When the concentration has been unstable for a while and/or has been alarmingly high recently, it may be wiser to increase the frequency of measuring the concentration. In this embodiment, the processor calculates a moment in time at which a new measurement is needed.

In another embodiment the processor is further operative to calculate an advised medication, using the concentration and at least one of the previously determined concentrations. In the safe health zone, medication levels may stay the same or may even be reduced. In the higher risk health zones, medication levels may be increased. Medication levels do not only depend on the current health zones, but may also depend on other parameters. If, for example, the health zone indicator indicates a transition from the highest risk zone to a moderate risk zone, an increase of the medication level may not be needed. An increase of the medication level may be however be needed, when the health zone indicator indicates a transition from the lowest risk zone to a moderate risk zone. Also current medication levels, medication levels in the recent past, the time of day and other parameters may be taken into account. According to a second aspect of the invention, a method is provided, comprising receiving a breath of a user, determining a concentration of at least one element in the breath, storing in a database, the concentration and a corresponding time at which the concentration is stored, comparing the concentration to at least one threshold for determining a health zone corresponding to the concentration and recalculating the at least one threshold, based on the concentration and at least one concentration determined in an earlier measurement and indicating the health zone.

These and other aspects of the invention are apparent from and will be elucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

Figure 1 shows an embodiment of the breath analysis device according to the invention,

Figure 2 shows the embodiment of figure 1 with the bodywork opened, Figure 3 shows a flow diagram of a method according to the invention, and

Figure 4 shows a flow diagram of another method according to the invention.

DETAILED DESCRIPTION OF THE INVENTION Figure 1 shows an embodiment of the breath analysis device 10 according to the invention. The device 10 comprises a gas inlet 11 for receiving the user's breath. The user provides the breath by exhaling into the gas inlet 11. Inside the device 10, the exhaled breath is analyzed as will be explained later on with reference to the other figures. The device 10 further comprises a display 15, a few function buttons 16a-d, a speaker 18 and a socket 19 for receiving a connector cable.

The display 15 shows the results of the measurement. In a simple embodiment, the display 15 only comprises two LEDs. For example, a green LED for indicating that the concentration is in the safe zone and a red LED for indicating higher risk. In the embodiment shown in figure 1, the display 15 is a pixel based display, such as a LCD display. Amongst others, the display 15 shows a traffic light 151 for indicating the health zones. The use of the traffic light 151 ensures a quick and very clear indication for the user of the health zone determined by the processor. The use of a traffic light 151 is preferable because the colors of a traffic light 151 (green, orange/yellow, red) are automatically associated with 'safe', 'moderate risk' and 'high risk'. Additional to the traffic lights 151, the display 15 shows a text area 152 for indicating the exact concentration measured, the advised moment for the next measurement, the advised medication and other information. In an embodiment of the traffic-light like output, green indicates stable conditions and no need for changing medication, yellow or orange indicates a health warning and an advise to increase the amount of medication, red indicates danger and an advise to call a doctor and a green light together with a blinking yellow/orange light indicates an advise to lower the amount of medication.

The function buttons 16a-d are for operating the device. An on/off button 16a is used for turning on or off the power of the device. Other function buttons 16b-d may be used for starting a measurement, changing settings, viewing data, selecting an element for measuring and lots of other functions.

The speaker 18 may, for example, be used for indicating when it is time to make a measurement, indicating when a user has blown enough air into the device 10 and may stop blowing out or sounding an alarm when the concentration exceeds an alarm threshold. The socket 19 may be arranged to receive a USB connector, for coupling the device 10 to a personal computer and allowing the user to download the data from the database to his own computer. Of course also other well known types of connections may be used. Additionally, via this connection, power may be supplied to the device 10 or to a rechargeable battery inside the device 10. Via the computer, it may be possible to communicate the data to an external server. Communication with a nearby computer or an external server somewhere on the Internet may alternatively be effected via a wireless transmitter and/or receiver (not shown).

For example, the stored data is transferred to an e-care center and if necessary, a medically trained person at the center may initiate or approve modification of the algorithms for calculating thresholds, the moment of the next measurement or the dosage of the medication to come to a better medication control. In addition, the e-center may send messages with advice to the user. The algorithms may temporarily be changed during, e.g., a period of influenza. Some function parameters of the functions used for recalculating the thresholds may be changed according to external circumstances, such as weather, time of year or a period of influenza. The new function parameters may be provided by an external server.

Figure 2 shows the embodiment of figure 1 with the bodywork opened. In figure 2 a conduit 17 is shown for bringing the exhaled breath of the user to the analyzer 12. The analyzer 12 analyzes the exhaled breath and determines the concentration of the element concerned, e.g., NO. The whole measurement and operation of the device 10 are controlled by a processor 14 to which the analyzer 12 is coupled. The processor 14 is further coupled to a storage medium with a database 13 for storing the measurement data and the corresponding time at which the measurement data is stored. Using the data in the database 13, the processor 14 determines the current health zone and calculates the new thresholds, advised measurement moment and medication dosage. Via a bus 20 the information received and calculated by the processor 14 is sent to the display 15 for showing it to the user. The bus 20 also comprises communication lines for controlling the speaker 18 and for receiving user instructions via the function keys 16a-d. The USB connector 19 and the wireless transmitter/ receiver, if present, are also coupled to the processor 14.

Figure 3 shows a flow diagram of a method according to the invention. The method starts with a breathing step 301 for receiving a breath of a user, followed by an analysis step 302 for determining the concentration of the element concerned in the exhaled breath of the user. The determined concentration and the time of the measurement are then stored in the database. In the first comparison step 303, the measured concentration is compared to a first threshold T₁. If the measured concentration is lower than T₁, than the concentration is in the 'safe' zone and a green light of the traffic light 151 is turned on in step 304. If the measured concentration is higher than T₁, then, in a second comparison step 305, the concentration is compared to a higher threshold T₂. If the measured concentration is lower than T₂, then the concentration is in the 'moderate risk' zone and a yellow/ orange light of the traffic light 151 is turned on in step 306. If the measured concentration is higher than T₂, than the concentration is in the 'high risk' zone and a red light of the traffic light 151 is turned on in step 308. Furthermore, the concentration is compared to an alarm threshold T3 in step 309. If the concentration exceeds the alarm threshold T3, then an alarm scenario is initiated in alarm step 310. The alarm scenario may comprise, e.g., making alarming sounds with the speaker 18, flashing the red light of the traffic light 151 or displaying a phone number of a doctor to contact.

After turning on the green, orange/yellow or red light, the thresholds are recalculated in threshold recalculation step 307. The new thresholds are based on the measured concentration and at least one other concentration already stored in the database. For example, after a measurement x, the new thresholds T₁, T₂ and T₃ for a NO concentration ([NO]) of the exhaled breath are given by the following generalized function: Ti,2,3 = ki,₂,3 * h([NOf, [NOf¹, [NOf², ...) The values k_1;2,3 may be predetermined and equal for all users, provided by a doctor or depend on some user characteristics, such as age, sex and weight. By taking into account earlier measurements (x-1, x-2, ...), the thresholds are adapted to the person using the device 10. If for example, the concentration is always somewhat higher on Saturday, but decreases to a normal level on Sundays, the threshold for a measurement to be done at Saturday may be increased. An increased concentration on Saturday will then not initiate corrective action. If however, the concentration is on the 'Saturday level' on another day, the thresholds may be lower, bringing the user in another health zone.

In an advanced embodiment, thresholds for one element concentration may depend on concentrations of other elements. A certain concentration of a first element may result in a higher risk, if the concentration of another element is higher or lower than usual. Similar generalized algorithms may be used for determining when to make a next measurement or how to adapt a dosage of medication: next measurement = f([NO]^x, [NOf^"1, [NOf^"2, ...) advised medication = g([NO]^x, [NOf^"1, [NOf^"2, ...) An additional safety measure 311 may be built into the device by initiating the alarm scenario when the advised medication exceeds a certain threshold (g > A). The medication alarm threshold may be predefined or also dependent on the concentration measurements. Figure 4 shows a flow diagram of another method according to the invention. The method is similar to the method of figure 3. However, in this embodiment the thresholds, the time for the next measurement and the advised medication is calculated before determining the health zone corresponding to the measured concentration. Furthermore an extra comparison step 402 and an extra indicator step 403 are introduced to provide a clearer visual difference between the 'high risk' health zone and the 'alarming phase'. The extra indicator step 403 preferably consists of turning on another light than one of the lights of the traffic light 151. Other ways of indicating the alarm phase may also be applied.

It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. Use of the verb "comprise" and its conjugations does not exclude the presence of elements or steps other than those stated in a claim. The article "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. The invention may be implemented by means of hardware comprising several distinct elements, and by means of a suitably programmed computer. In the claims enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

Claims

CLAIMS:

1. A breath analysis device (10) comprising: an inlet (11) for receiving a breath of a user, an analyzer (12) for determining a concentration of at least one element in the breath, - a database (13) for comprising previously determined concentrations and corresponding times at which the previously determined concentrations have been stored in the database, a processor (14) for storing in the database, the concentration and a corresponding time at which the concentration is stored, comparing the concentration to at least one threshold for determining a health zone corresponding to the concentration and recalculating the at least one threshold, based on the concentration and at least one of the previously determined concentrations and - an output (15) for indicating the health zone.

2. A breath analysis device (10) according to claim 1, wherein the output (15) is adapted to show at least two different colors, each color corresponding to a different health zone.

3. A breath analysis device (10) according to claim 2, wherein the output (15) is adapted to show at least three different colors, each color corresponding to a different health zone.

4. A breath analysis device (10) according to claim 1, wherein the processor (14) is further operative to calculate an advised time for analyzing a next breath, using the concentration and at least one of the previously determined concentrations.

5. A breath analysis device (10) according to claim 1, wherein the processor (14) is further operative to calculate an advised medication, using the concentration and at least one of the previously determined concentrations.

6. A breath analysis device (10) according to claim 1, further comprising means for transmitting the concentration to an external server.

7. A breath analysis device (10) according to one of the claims 1, further comprising means for receiving a function parameter from an external server and wherein the recalculation of the at least one threshold is also based on the received function parameter, the function parameter reflecting external circumstances.

8. A breath analysis device (10) according to claim 1, wherein the processor (14) is further operative to compare the concentration to an alarm threshold, and to advise the user to contact a doctor if the concentration is above the alarm threshold.

9. A breath analysis device (10) according to claim 8, wherein the processor (14) is further operative to recalculate the alarm threshold, based on the concentration and at least one of the previously determined concentrations.

10. A method for analyzing a breath comprising: receiving (301) a breath of a user, determining a concentration (302) of at least one element in the breath, storing in a database, the concentration and a corresponding time at which the concentration is stored, comparing (303, 305, 402) the concentration to at least one threshold for determining a health zone corresponding to the concentration and recalculating (307) the at least one threshold, based on the concentration and at least one concentration determined in an earlier measurement, and - indicating (304, 306, 308, 403) the health zone.