Nasal airflow measuring devices and methods
10251581 ยท 2019-04-09
Inventors
Cpc classification
A61B5/097
HUMAN NECESSITIES
A61B5/082
HUMAN NECESSITIES
International classification
Abstract
Devices and methods for measuring and quantifying airflow through the adult human nose by detecting and measuring the amount of moisture condensate in contact with a pair of flat surfaces or substrates positioned beneath the patient's nose for a predetermined length of time, usually about three (3) seconds. The device comprises a microprocessor, a memory, an output device and a moisture sensing unit. The moisture sensing unit, comprising twin left and right detectors, produces output signals representative of the amounts of moisture condensate in contact with the left and right detectors, respectively. The microprocessor determines the volume density, current density, or relative humidity density from a series of measurements of the condensation as it propagates and decays during exhalation. The microprocessor stores the results in the memory and transmits the data, as well as calculated nasal condition information, to the output device, preferably a digital display. The device and techniques for using the device are useful in diagnosing nasal obstructions, documenting patient symptoms, and assessing potential responses to therapy.
Claims
1. A method of quantifying airflow through a patient's nose using a microprocessor, a memory, an output device and a moisture sensing unit, the moisture sensing unit comprising a left nostril detector and a right nostril detector, each configured to produce output signals representative of the amounts of moisture currently in contact with said left nostril detector and said right nostril detector, respectively, the method comprising the steps of: a) positioning the moisture sensing unit near the patient's nose while the patient exhales for a predetermined length of time so that a substantial portion of the air expelled from the left nostril of the patient's nose during the exhalation will strike the left nostril detector and a substantial portion of the air expelled from the right nostril of the patient's nose during the exhalation will strike the right nostril detector; b) during the predetermined length of time, repetitively recording the output signals produced by the left nostril detector of the moisture sensing unit, thereby generating a plurality of discrete output signals for the left nostril, the plurality of discrete output signals representing the changes in output signals produced by the left nostril detector in response to changes in the amount of moisture in contact with the left nostril detector, and storing the plurality of discrete output signals for the left nostril in the memory; c) during the predetermined length of time, repetitively recording the output signals produced by the right nostril detector of the moisture sensing unit, thereby generating a plurality of discrete output signals for the right nostril, the plurality of discrete output signals representing the changes in output signals produced by the right nostril detector in response to changes in the amount of moisture in contact with the right detector, and storing the plurality of discrete output signals for the right nostril in the memory; d) with the microprocessor, calculating a left nostril flow density by summing the discrete output signals in the plurality of discrete output signals for the left nostril, and calculating a right nostril flow density by summing the discrete output signals in the plurality of discrete output signals for the right nostril; e) presenting the left nostril flow density and the right nostril flow density on the output device; f) wherein the left nostril detector and the right nostril detector of the moisture sensing unit each comprises either: f1) a low conductivity substrate with a flat surface; a layer of a high conductivity material affixed to the flat surface of the low conductivity substrate; a power source configured to pass an electric current through the layer of high conductivity material; an ammeter configured to produce an output signal; wherein (i) at least some of the moisture in the air expelled from the patient's nostril condenses on the layer of high conductivity material, (ii) the magnitude of electric current passing through the layer of high conductivity material varies in response to changes in the amount of condensed moisture in contact with the layer of high conductivity material, and (iii) the output signal produced by the ammeter varies in direct proportion to changes in the magnitude of the electric current passing through the layer of high conductivity material; or f2) a transparent material with a flat surface; a video camera having a lens that is focused on the flat surface of the transparent material; and a sub-processor configured to receive image data from the video camera during the exhalation of the patient onto the moisture sensing unit and to calculate, based on the received image data, the surface area of a plume of condensed moisture collected on the flat surface of the transparent material during the exhalation, and to produce the output signal that varies in direct proportion to changes in the surface area of the plume of condensed moisture collected on the flat surface of the transparent material; or f3) a humidity sensor; a sub-processor configured to (i) receive humidity data from the humidity sensor during the exhalation of the patient onto the moisture sensing unit, (ii) to calculate, based on the received humidity data, the relative humidity of the air expelled from the patient's nostril during the exhalation, and (iii) to produce an output signal that varies in direct proportion to changes in the relative humidity of the air expelled from the patient's nostril.
2. The method of claim 1, further comprising: a) calculating with the microprocessor a sum of the left nostril flow density and the right nostril flow density; and b) presenting the sum on the output device.
3. The method of claim 1, further comprising: a) calculating with the microprocessor a ratio of the left nostril flow density to the right nostril flow density; and b) presenting the ratio on the output device.
4. The method of claim 1, wherein the output device comprises a digital display screen.
5. The method of claim 1, wherein: a) the output device comprises one or more light emitting diodes; and b) presenting the left nostril flow density and the right nostril flow density on the output device comprises activating the one or more light emitting diodes.
6. The method of claim 1, wherein the predetermined length of time is between three and five seconds.
7. The method of claim 1, wherein the predetermined length of time is about three seconds.
8. The method of claim 1, wherein the low conductivity substrate comprises a piece of glass or a piece of plastic.
9. The method of claim 1, wherein the high conductivity material comprises indium nitride (InN).
10. A nasal airflow evaluation instrument, comprising: a) a microprocessor; b) a memory; c) an output device; d) a moisture sensing unit comprising a left nostril detector and a right nostril detector, the left nostril detector and the right nostril detector each configured to produce output signals representative of the amounts of moisture currently in contact with said left nostril detector and said right nostril detector, respectively; and e) an application program stored in the memory, the application program comprising program instructions that, when executed by the microprocessor, will cause the microprocessor to (i) activate the moisture sensing unit; (ii) repetitively record the output signals produced by the left nostril detector of the moisture sensing unit over a predetermined length of time, thereby generating a plurality of discrete output signals for the left nostril, the plurality of discrete output signals representing the changes in output signals produced by the left nostril detector in response to changes in the amount of moisture in contact with the left nostril detector, and store the plurality of discrete output signals for the left nostril in the memory, (iii) repetitively record the output signals produced by the right nostril detector of the moisture sensing unit over a predetermined length of time, thereby generating a plurality of discrete output signals for the right nostril, the plurality of discrete output signals representing the changes in output signals produced by the right nostril detector in response to changes in the amount of moisture in contact with the right nostril detector, and store the plurality of discrete output signals for the right nostril in the memory, (iv) calculate a left nostril flow density by adding together the discrete output signals in the plurality of discrete output signals for the left nostril, (v) calculate a right nostril flow density by adding together the discrete output signals in the plurality of discrete output signals for the right nostril, and (vi) present the left nostril flow density and the right nostril flow density on the output device, f) wherein the left nostril detector and the right nostril detector of the moisture sensing unit each comprises either: f1) a low conductivity substrate with a flat surface; a layer of a high conductivity material affixed to the flat surface of the low conductivity substrate; a power source configured to pass an electric current through the layer of high conductivity material; an ammeter configured to produce an output signal; wherein (i) at least some of the moisture in the air expelled from the patient's nostril condenses on the layer of high conductivity material, (ii) the magnitude of electric current passing through the layer of high conductivity material varies in response to changes in the amount of condensed moisture in contact with the layer of high conductivity material, and (iii) the output signal produced by the ammeter varies in direct proportion to changes in the magnitude of the electric current passing through the layer of high conductivity material; or f2) a transparent material with a flat surface; a video camera having a lens that is focused on the flat surface of the transparent material; and a sub-processor configured to receive image data from the video camera during the exhalation of the patient onto the moisture sensing unit and to calculate, based on the received image data, the surface area of a plume of condensed moisture collected on the flat surface of the transparent material during the exhalation, and to produce the output signal that varies in direct proportion to changes in the surface area of the plume of condensed moisture collected on the flat surface of the transparent material; or f3) a humidity sensor; a sub-processor configured to (i) receive humidity data from the humidity sensor during the exhalation of the patient onto the moisture sensing unit, (ii) to calculate, based on the received humidity data, the relative humidity of the air expelled from the patient's nostril during the exhalation, and (iii) to produce an output signal that varies in direct proportion to changes in the relative humidity of the air expelled from the patient's nostril.
11. The nasal airflow evaluation instrument of claim 10, wherein the application program further includes program instructions that, when executed by the microprocessor, will cause the microprocessor to: a) calculate a sum of the left nostril flow density and the right nostril flow density; and b) present the sum on the output device.
12. The nasal airflow evaluation instrument of claim 10, wherein the application program further includes program instructions that, when executed by the microprocessor, will cause the microprocessor to: a) calculate a ratio of the left nostril flow density to the right nostril flow density; and b) present the ratio on the output device.
13. The nasal airflow evaluation instrument of claim 10, wherein the output device comprises a digital display screen.
14. The nasal airflow evaluation instrument of claim 10, wherein: a) the output device comprises one or more light emitting diodes; and b) the application program further includes program instructions that, when executed by the microprocessor, will cause the microprocessor to activate the one or more light emitting diodes.
15. The nasal airflow evaluation instrument of claim 10, wherein the predetermined length of time is between two and five seconds.
16. The nasal airflow evaluation instrument of claim 10, wherein the predetermined length of time is about three seconds.
17. The nasal airflow evaluation instrument of claim 10, wherein the low conductivity substrate comprises a piece of glass or a piece of plastic.
18. The nasal airflow evaluation instrument of claim 10, wherein the high conductivity material comprises indium nitride (InN).
19. The nasal airflow evaluation instrument of claim 10, wherein the moisture sensing unit further comprises a partition, interposed between the left nostril detector and the right nostril detector, the partition being configured to reduce cross-mixing of air expelled from the patient's left and right nostrils, respectively, prior to said air striking the left nostril detector and the right nostril detector.
Description
BRIEF DESCRIPTION OF THE FIGURES
(1) The various advantages of the embodiments of the present invention will become apparent to one skilled in the art by reading the following specification and appended claims, and by referencing the following drawings, in which:
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
(12) Non-limiting examples of devices and methods arranged and performed according to certain embodiments of the present invention will now be described in some detail by reference to the accompanying figures.
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(14) Given that condensation and condensate surface plumes are both measureable and quantifiable, and with an understanding of the relationships stated above, there is provided in one embodiment of the present invention a method of assessing and diagnosing nasal conditions, such as CNO, by holding a panel of glass (such as a mirror), or plastic, immediately under the nose, orthogonal to the upper lip at the base of the columella, in the same manner as shown by the orientation of substrate 120 to source 110 in
(15) As shown in
(16)
(17) The surface area () and duration (t.sub.0-t.sub.3) of condensation associated with each nostril plume is directly proportional to the amount of water that condenses on the glass in response to the flow of air leaving the nasal passage, which in turn is also useful to interpret flow through the respective nostrils. The greater the surface area and the longer the duration from t.sub.0-t.sub.3, the greater the amount of condensed water. Since each plume surface area is therefore a function of time, it is represented as (t). Because the pattern is fully developed at the completion of tidal exhalation, then the area under the curve, or integral of (t) from the initiation of exhalation (t.sub.0) to the complete evaporation of the condensation plume several seconds later (t.sub.3) is representative of the total volume of the plume:
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Or, in the case of the nose with nostrils A and B,
(19)
where .sub.A(t) is the surface area of plume created from nostril A and .sub.B(t) is the surface area of the plume created from nostril B.
(20) At tidal flows, unforced exhalation correlates closely to inhalation in cases of static (fixed, anatomic) nasal obstruction (e.g. deviated septum or turbinate hypertrophy). Low flow minimizes any Bernoulli effects (narrowing of the nasal valves due to inhalation). In instances of dynamic obstruction (variable, support deficiencies) where obstruction becomes worse with increasing flow, (i.e. nasal valve collapse), the dynamic contribution of obstruction during tidal flow is small so that exhalation measurements still correlate with inhalational flow.
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(22) The change in the amount of current flowing across a flat glass surface in response to the presence of condensation on that glass surface has been documented by Dumitru, et al. using indium nitride (InN) condensation sensors (Sensors 2013, 13, 16940-16949).
(23) In one embodiment of the present invention, the application program 441 causes the processor 440 to perform mathematical operations that inverts the changing current drops as recorded by ammeter 430 and ammeter 435 as a function of time, I(t).sup.1, and integrates it across the duration of the exhalation from t.sub.0 to t.sub.2, to quantitate the condensation event. The processor 440 calculates the current densities J.sub.A, J.sub.B in accordance with the equations given below, and then compares them as a sum J.sub.A+J.sub.B and as a quotient J.sub.A/J.sub.B.
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(25) The four resulting parameters, J.sub.A, J.sub.B, (J.sub.A+J.sub.B), (J.sub.A/J.sub.B), are presented on a digital LED display 445. The numbers displayed will remain until the device 400 is reset for a new measurement. Prior to reset, the data can be transmitted via wired or wireless channels (such as USB or Bluetooth, for example) to a second device for recording. With these four parameters, clinicians and researchers can assess flow from the nose in total (J.sub.A+J.sub.B), flow from each nostril independently (J.sub.A, J.sub.B), and as a ratio (J.sub.A/J.sub.B) that compares the nostrils to each other, wherein a ratio of J.sub.A/J.sub.B=1 indicates the flow through nostrils is equal, for example.
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(27) If the value of either I.sub.A or I.sub.B at step 525 is greater than the baseline current value, and the current density variables of J.sub.A and J.sub.B are not both still at zero, the system moves to check if three (3) seconds has elapsed at step 540; if the measurement interval has been less than three (3) seconds, the system displays an error message at step 545 and the process stops. If three (3) seconds has transpired, then the values of current density variables J.sub.A and J.sub.B are passed on to step 560, in which the sum of the current density variables is taken and the ratio of the current density values is calculated. At this point, the system has determined values for J.sub.A, J.sub.B, J.sub.A+J.sub.B, and J.sub.A/J.sub.B, which are then displayed at step 565 before the process halts.
(28) If the value of either I.sub.A or I.sub.B at step 525 is less than the baseline current values I.sub.0 established at step 510, then a drop in current has occurred and the system proceeds to step 550 to determine if three (3) seconds have elapsed since the start time in the procedure. As long as the current time minus the start time remains less than three (3) seconds, the system will move on to step 555, during which the value of the current density variables J.sub.A and J.sub.B are added to the measured values of I.sub.A or I.sub.B and the results are stored as the new values for J.sub.A and J.sub.B. The system waits for the designated 0.001 seconds and then loops back through steps 520-555. In this manner, a series of successive measurements are taken, and these measurements are quantized and stored until three (3) seconds have elapsed, at which point the system proceeds to step 560 where the system determines values for J.sub.A, J.sub.B, (J.sub.A+J.sub.B), and (J.sub.A/J.sub.B), which are then displayed at step 565 before the process halts.
(29) In an alternative embodiment, nasal airflow is assessed using the change in relative humidity that occurs as nasal air is exhaled. This embodiment is substantially similar to the device 400 as shown in
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(32) If the value of either RH.sub.A or RH.sub.B at step 625 is less than the baseline relative humidity value, and the relative humidity density variables of H.sub.A and H.sub.B are not both still at zero, the system next determines whether three (3) seconds have elapsed at step 640. If it has been less than three seconds since the start time, the system displays an error message at step 645 and the process stops. If three seconds have elapsed, then the values of relative humidity density variables H.sub.A and H.sub.B are passed on to step 660, in which a sum of the relative humidity density variables is taken and the ratio of the relative humidity density values is calculated. At this point, the system has determined values for H.sub.A, H.sub.B, H.sub.A+H.sub.B, and H.sub.A/H.sub.B, which are then displayed at step 665 before the process halts.
(33) If the value of either RH.sub.A or RH.sub.B at step 625 is greater than the baseline relative humidity value RH.sub.0 established at step 610, then the system proceeds to step 650 to determine if three (3) seconds have elapsed since the start time. As long as the current time minus the start time remains less than three (3) seconds, the system will move on to step 655, during which the value of the relative humidity density variables H.sub.A and H.sub.B are added to the measured values of RH.sub.A and RH.sub.B and the results are stored as the new values for H.sub.A and H.sub.B. The system waits for the designated 0.001 seconds and then loops back through steps 620-655. In this manner, a series of successive measurements are taken, and these measurements are quantized and stored until the predetermined three (3) second time period has elapsed, at which point the system proceeds to step 660 where the system determines values for H.sub.A, H.sub.B, (H.sub.A+H.sub.B), and (H.sub.A/H.sub.B), which are then displayed at step 665 before the process halts.
(34) As with the previous embodiment, a digital LED display shows the resulting four parameters: H.sub.A, H.sub.B, (H.sub.A+H.sub.B), (H.sub.A/H.sub.B). The numbers displayed will remain until the device is reset for a new measurement. Prior to reset, the data can be transmitted via wired or wireless channels (such as USB or Bluetooth, for example) to a second device for recording. With these four parameters, clinicians and researchers can assess flow from the nose in total (H.sub.A+H.sub.B), flow from each nostril independently (H.sub.A, H.sub.B), and as a ratio (H.sub.A/H.sub.B) that compares the nostrils to each other, with a H.sub.A/H.sub.B=1 indicating the flow through nostrils is equal, for example.
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(36) The sub-processors 735 and 740 receive images in real time from camera 715 and camera 720, respectively, and the image data is arrayed onto a 10001000 pixel grid. If condensation exists within a pixel, that pixel is given a value of 1, and if no condensation exists, then the pixel is given a value of 0. The surface area of each approximately elliptical plume is generated by calculating the number of pixels with value=1 from the center of the grid along orthogonal x- and y-axes to generate radii r.sub.1 and r.sub.2, and using the relation r.sub.1r.sub.2.
Surface Area Calculation for an Ellipse
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=r.sub.1r.sub.2
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(t)=r.sub.1(t)r.sub.2(t)
(39) For example, in a 44 cm grid containing 10001000 pixels, each pixel is 0.04 mm0.04 mm.) This measurement is repeated at predetermined regular intervals, such as every 1/1000th second, from the time the condensation first appears (t.sub.0) to the time the condensation disappears (t.sub.3). In a plume lasting 8 seconds, therefore, each sub-processor would yield 800 values. However, since the time to exhale a tidal volume through a normal (unobstructed) nose can be significantly shorter than an obstructed nose, a more useful measurement is from t.sub.0 to t.sub.2, which is roughly a 3 second interval in the normal nose. Each of the sub-processors 735 and 740 generates the sum of these surface area values to approximate the integral of (t) from t.sub.0 to t.sub.2, where t.sub.2=3 seconds. Nostril A:
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(42) The output signal of each sub-processor 735 and 740 is labeled V.sub.A and V.sub.B, and represents the volume densities associated with nostrils A and B (with units cm2 time). These data V.sub.A and V.sub.B are relayed to a central processor that then calculates the sum (V.sub.A+V.sub.B), and the quotient (V.sub.A/V.sub.B), representing the total plume condensation volume densities from both nostrils, and the ratio of the plume condensation volume densities, respectively. (A small plume that decays quickly (indicative of minimal condensation and therefore minimal airflow) will yield a small V.sub.A or V.sub.B, whereby a large plume that decays slowly (indicative of more condensation and therefore more significant airflow) will yield a large V.sub.A or V.sub.B.). While
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(44) If the system determines at step 825 that condensation is not present in either of the images, and the volume density variables of V.sub.A and V.sub.B both do not hold values of zero, the system checks to see at step 840 if three (3) seconds have elapsed. If the exhalational measurement interval has been less than 3 seconds, the system displays an error message at step 845 and the process stops. If three (3) seconds have elapsed, then the values of volume density variables V.sub.A and V.sub.B are passed on to step 865, in which a sum of the volume density variables is taken and the ratio of the volume density values is calculated. At this point, the system has determined values for V.sub.A, V.sub.B, V.sub.A+V.sub.B, and V.sub.A/V.sub.B, which are then displayed at step 870 before the process halts.
(45) If the system determines at step 825 that condensation is indeed present in either image taken by camera A or camera B the system next proceeds to step 850 to determine if three (3) seconds have elapsed in the procedure. As long as the current time minus the start time remains less than 3 seconds, the system will move on to step 855, during which the surface areas of the condensation plumes is calculated in the manner discussed above, and these values are stored as the surface area variables S.sub.A and S.sub.B. At step 860, the value of the volume density variables V.sub.A and V.sub.B are added to the calculated surface area values of S.sub.A and S.sub.B and the results are stored as the new values for V.sub.A and V.sub.B. The system waits for the designated 0.001 seconds and then loops back through steps 820-860. In this manner, a series of successive image-based measurements are taken, and these measurements are quantized and stored until three (3) seconds have passed, at which point the system proceeds to step 865 where the system determines values for V.sub.A, V.sub.B, (V.sub.A+V.sub.B), and (V.sub.A/V.sub.B), which are then displayed at step 670 before the process halts.
(46) These four calculated values V.sub.A, V.sub.B, (V.sub.A+V.sub.B) and (V.sub.A/V.sub.B) are then output to the LED display, such as the one shown as element 755 of device 700, which can be transferred wirelessly to a second device by wired or wireless channel (such as USB or Bluetooth) for recording of numerous measurements.
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(48) The display for Subject C shows robust flow in the left nostril (J.sub.A=8) and negligible flow in the right nostril (J.sub.B=1); overall nasal airflow is shown as being high (J.sub.A+J.sub.B=9), but given the high ratio (J.sub.A/J.sub.B=8) an incomplete unilateral nasal obstruction of the right nostril is evident. The display for Subject D shows the inverse situation, with negligible flow in the left nostril (J.sub.A=1) and robust flow in the right nostril (J.sub.B=8), which is indicated also by a ratio given as less than zero (J.sub.A/J.sub.B=0.125). In the display for Subject E, high airflow from the left nostril is indicated, along with a complete obstruction of the right nostril. A ratio indicator displaying infinity (or a division by zero flag) tells the observer that the right nostril airflow is at absolute zero, indicating a complete unilateral nasal obstruction. In the display for Subject F, high airflow from the right nostril is indicated, along with a complete unilateral obstruction of the left nostril. A ratio indicator showing zero tells the observer that the airflow through the left nostril is completely obstructed.
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(50) The above-described preferred embodiments are intended to illustrate the principles of the invention, but not to limit its scope. Various other embodiments, modifications and equivalents to these preferred embodiments may occur to those skilled in the art upon reading the present disclosure or practicing the claimed invention. Such variations, modifications and equivalents are intended to come within the scope of the invention and the appended claims.