Title of Invention

METHOD AND SYSTEM FOR ANALYSING RESPIRATORY TRACT AIR FLOW

Abstract A method for determining airflow in a portion of a respiratory tract comprising determining a total acoustic energy in a region of a body surface overlying the portion of the respiratory tract. The airflow may be integrated over a time interval in order to determine an air volume that has flowed in the portion of the respiratory tract during the time interval. A graph of the flow rate as a function of the volume may be displayed and analyzed as in spirometry. The invention also provides a system (100) for carrying out the method.
Full Text FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10, rule 13)
"METHOD AND SYSTEM FOR ANALYSING RESPIRATORY
TRACT AIR FLOW"
DEEPBREEZE LTD., of 2 Hailan Street, P.O. Box 140, Industrial Park Or Akiva 30600, Israel.
The following specification particularly describes the invention and the manner in which it is to be performed.
GRANTED
5-12-2007
ORIGINAL
917/MUMNP/2006


METHOD AND SYSTEM FOR ANALYSING RESPIRATORY TRACT AIR FLOW
IIELD OF THE INVENTION
This invention relates to medical devices and methods and more specifically, to such devices and methods for analyzing respiratory tract function.
BACKGROUND OF THE INVENTION
Spirometry is a common test of respiratory function mat involves measuring me total volume of air inhaled into the lungs over a respiratory cycle, spirometry test is usually carried out by having a subject inhale air through a tube connected to an air flow meter mat measures the flow rate of air inhaled into the respiration system during the inspiration phase of the respiratory cycle. At the termination of the inspiration phase, the subject exhales through the tube and the flow rate of air exhaled during the expiration phase is measured A curve is then generated showing the air flow as a function of time. The curve is analyzed to obtain one or more respiratory parameters of the subject that are used to assess intrathorax airways obstruction. For example, the so-called "forced expiratory volume in one second" (FEVi) is obtained in a test performed during a maximum effort force expiratory vital capacity maneuver started from total lung capacity. FEVt is a well characterized test of respiratory function and provides useful information in diseased and normal states. In chronic obstructive pulmonary disease, the level of FEV, is used to grade the severity of the obstruction.
It is known to attach a plurality of microphones to a subject"s chest or back in order to record respiratory tract sounds at a plurality of locations on the body surface. U.S. Patent Application No 10/338,742 published on January 9,

2003, and having the Publication Number US 2003-0139679 discloses a method for analyzing respiratory tract sounds detected by a plurality of microphones affixed to a subject"s back or chest The recorded sound signals are processed to determine an average acoustical energy P(x,t„t2) at a plurality of locations x on the body surface over a time interval from ti to t2.
SUMMARY OF THE INVENTION
The present invention is based on the finding mat the average acoustic energy over a region of an individual"s back or chest or during a time interval from ti to t2, can be correlated with the air flow in the portion of the respiratory tract underlying the region during mat time interval Thus, in its first aspect the invention provides a method for calculating an air flow in at least a portion of an individual"s respiratory tract The portion of the respiratory tract may be, for example, the left or right rang, or a single lobe within one of the lungs. In accordance with this aspect of the invention, a plurality of microphones is fixed onto a subject"s back or chest over the portion of me respiratory tract, and respiratory tract sounds are recorded from the region over a time interval from t» to ti- An average acoustical energy during the subinterval is determined at a plurality of locations x in the region. The total average acoustical energy, summed over the locations x is then correlated with the airflow in the portion of the respiratory tract Correlating the total acoustic energy with the airflow may be done, for example, using previously determined calibration curves. In a presently preferred embodiment an airflow is calculated that is equal to the logarithm of the total acoustic energy. The process may then be repeated during the expiratory phase of the respiratory cycle.

The airflow during each subinterval obtained by the method of the invention, may be displayed in the form of a graph of the airflow as a function of time over a respiratory cycle. The invention allows regional assessment of the respiratory tract performance.
The airflow in the lungs as a function of time during the inspiratory phase obtained in accordance with the invention may be integrated from a time to to a time t to produce a total volume of air that has flowed into the airways from time to to t. The airflow at a time t may be plotted as a function of the total volume of air that has flowed into the airways from to to time t, to produce a spirometry curve for inspiration. The process may then be repeated for the expiratory phase of the respiratory cycle.
Thus, in its first aspect, the invention provides a method for determining airflow in a portion of a respiratory tract comprising determining a total acoustic energy in a region of a body surface ovcrrying the portion of the respiratory tract
In its second aspect, the invention provides a system for deteratining airflow in a portion of a respiratory tract comprising a processor configured to determine a total acoustic energy in a region of a body surface overlying the portion of the respiratory tract
BRIEF DESCRIPTION OF THE DRAWINGS
In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
Fig. 1 shows a system for analyzing respiratory tract airflow in accordance with one embodiment of the invention;
Fig. 2 shows a flow chart diagram for carrying out the method of the invention in accordance with one embodiment of the invention; and
Fig. 3a shows a spirometry curve for both lungs of an individual, and Fig. 3b shows a spirometry curve for the right lung.

DETAILED DESCRIPTION OF THE INVENTION
Fig. 1 shows a system generally indicated by 100 for analyzing respiratory tract airflow in a region of a respiratory system in accordance with one embodiment of the invention. A plurality of N sound transducers 105, of which four are shown, are applied to a planar region of the chest or back skin of individual 110. The transducers 105 may be applied to the subject by any means known in the art, for example using an adhesive, suction, or fastening straps. Each transducer 105 produces an analog voltage signal 115 indicative of pressure waves arriving to the transducer. The system 100 is used to obtain acoustic signals 115 over a time interval from to to W The analog signals 115 are digitized by a multichannel analog to digital converter 120. The digital data signals P(x,,t) 125, represent the pressure wave at the location x§ of the ith transducer (F= 1 to N) at time t The data signals 125 are input to a memory 130. Data input to the memory 130 are accessed by a processes 135 oonfiguixd to process the data signals 125. The signals 125 may be denoised by filtering components having frequencies outside of the range of respiratory sounds, for example, vibrations due to movement of the individual. Each signal 125 may also be subject to band pass filtering so mat only components in the signal within a range of interest are analyzed.
An input device such as a computer keyboard 140 or mouse 145 is used to input relevant information relating to the examination such as personal details of the individual 110. The input device 140 may also be used to input a subdivision of die time interval to to U into subintervals to, tu ta,...^. Alternatively, the times t2»- • -tm-i may be determined automatically by the processor 135. The processor 135 determines an average acoustic energy P(x,tf,tM) over each subinterval from ti to Vi> 1=0 to m-1 at a plurality of locations x in the region in a calculation involving at least one of the signals P(Xj,t).
The average acoustic energies are stored in the memory 130 and may be displayed on a display device 150 such as a CRT screen for diagnosis by a physician.

The processor is also configured to integrate the functions with
respect to x, i.e. to calculate in order to obtain a total acoustic
energy in the region of the respiratory tract during the interval from tj to tj+1- A previously obtained caUbration curve is then used by the processor to determine from the calculated acoustic energy, an air flow rate into (during inspiratory phase) or out of (during the expiratory phase) the region. A caUbration curve is preferably used, previously obtained on a subject having similar characteristics (gender, height, weight and age), as the individual 110. The processor is also configured to
integrate the functions with respect to time, , in
order to obtained the total volume of air mat has fkrvved in the airways from to to to, for each k from 1 torn.
The processor is also configured to display on the display device a
spirometry curve which is a plot of the flow rate during the
interval from tj to t1+1 as a function of the volume during the
same time interval.
The processor 135 may also perform an automatic differential diagnosis by comparing the spirometry curve to standard spirometry curves functions stored in the memory and known to be indicative of various disorders in the body region.
Fig. 2 shows a flow chart diagram for carrying out the method of die invention in accordance with one embodiment In step 200 the signals P(Xj,t) are obtained from N transducers placed at predetermined locations Xj for i from 1 to N in a region Ron an individual"s chest or back. In step 205 the processor 135
determines an average acoustic energy over each subinterval from tj to
ti, H) to m-1 at a plurality of locations Xj in the region R in a calculation involving at least one of the signals P(Xi,t).

In step 210, (he processor integrates the functions with respect
to x, in order to obtain acoustic energy in the airways during the
interval from tj to W In step 212 the processor obtains a flow rate of air in the region R of the airways from a calibration curve. In step 215, the processor
integrates the functions or die air flow rates widi respect to time,
in order to obtain die total volume of air mat has flowed into or
out of die region R from to to t^, for each k from 1 to m. In step 220, me processor displays on me display device a spirometry curve which is a plot of die air flow rate
as a function of die air volume
It will also be understood tiiat die system according to die invention may be a suitably programmed computet Likewise, me invention contemplates a computer program being readable by a computer for rawyntmg die method of die invention. The invention further contemplates a machine-readable memory tangibly embodying a program of instructions executable by die machine for executing die mediod of die invention.
Examples
A plurality of 20 sound transducers were applied to an individual"s back over each lung. Each transducer produced an analog voltage signal indicative of pressure waves arriving to die transducer over a respiratory cycle. The analog signals were digitized by a multichannel analog to digital converter. The digital data signals P(Xat), represent die pressure wave at die location x, of the ith transducer at time t The data signals were denoised by filtering components having frequencies outside of die range of respiratory sounds.
The respiratory cycle was divided into 0.1 sec subintervais and die subintervals were classified as belonging to either the inspiratory or die expiratory

phase of the respiratory cycle. An average acoustic energy was calculated
over each subinterval at a plurality of locations x over each lung from the signals P(x,,t).
For each lung, the functions were integrated with respect to x
in order to obtain a total airflow in the lung during the interval from tj to W The integrals were then integrated with respect to
tune, in order to obtain a function that can be correlated with
the total volume of air that has flowed into or out of each lung during die inspiratory and the expiratory phase, respectively, from the onset of the phase to a variable time V The logaridimof these integrals were calcinated and plotted as a function of time during the respiratory cycle in order to obtain a spirometry curve. The results are shown in Fig. 3. Fig. 3a shows a spirometry curve for both lungs. The portion of the curve corresponding to the expiratory phase of the respiratory cycle is plotted above the horizontal axis. The portion of the curve corresponding to the expiratory phase of die respiratory cycle is plotted bdow die horizontal axis. The volume values in die vertical axis may be correlated by using spirometry data of die individual obtained from a mechanical spirometer. Fig. 3b shows a spirometry curve for the right lung. The volume values in die vertical axis may be correlated by using spirometry data of die individual obtained from a mechanical spirometer on bom lungs.


We Claim:
1. A method for determining airflow in a portion of a respiratory tract comprising:
determining a total acoustic energy in a region of a body surface overlying the portion of the respiratory tract,
wherein the average acoustic energy is determined in a process comprising:
(a) obtaining signals P (xj,-, t) from N transducers placed at predetermined locations Xi for i from 1 to N in the region of the body surface;
(b) determining an average acoustic energy P (x, ti, tj+i,) over one or more time intervals ti to tj+1, at a plurality of locations x in the region in a calculation involving at least one of the signals P (XJ, t); and
(c) integrating the functions P (x, tj, t;+i) with respect to x, XxP (x, tj, tj+1) in order to obtain an airflow in the region during each of the time intervals.

2. The method as claimed in claim 1, optionally comprising integrating the functions £XP (x, tj, tj+1) with respect to time, £ to tk £XP (x, tj, tj+i) in order to obtain a total volume of air that has flowed in the region from to to tk, for each k from 1 to m.
3. The method as claimed in claim 2, optionally comprising displaying on a display device a plot of the flow rate £XP (x, tj, tj+i) as a function of the volume £ to ^ XxP (x, tj, UH).
4. The method as claimed in claiml, wherein the N transducers are placed in a region, said region being a single lung or a lobe of a lung.
5. The method as claimed in claiml, optionally comprising calculating a logarithm of an acoustical energy.
6. A system for determining airflow in a portion of a respiratory tract comprising:


a processor configured to determine a total acoustic energy in a region of a body surface overlying the portion of the respiratory tract,
wherein the average acoustic energy is determined in a process comprising:
(a) obtaining signals P (Xj, t) from N transducers placed at predetermined locations Xj; for i from 1 to N in the region of the body surface;
(b) determining an average acoustic energy P (x, ti, ti,) over one or more time intervals ti, to tj+1, at a plurality of locations x in the region in a calculation involving at least one of the signals P (xi, t) and
(c) integrating the functions P (x, tj, tj+i,) with respect to x, £XP (x> ti, ti+i) m order to obtain an airflow in the region during each of the time intervals.

7. The system as claimed in claim 6, wherein the processor is further configured to integrate the functions £XP (x, ti, ti+i) with respect to time, £ to * £XP (x, ti? tj+i) in order to obtain a total volume of air that has flowed in the region from to to tk, for each k from 1 to m.
8. The system as claimed in claim 7, optionally comprising the display device and wherein the processor is further configured to displaying on the display device a plot of the flow rate £XP (x, tj, tj+i) as a function of the volume £ to * ZxP (x, ti, tj+i).
9. The system as claimed in claim 6, wherein the N transducers are placed in a region, said region being a single lung or a lobe of a lung.
10. The system as claimed in claim 6, wherein the processor is optionally configured to
calculate a logarithm of an acoustical energy.
Dated this 1st day of August, 2006.
G. DEEPAK SRINIWAS OF K & S PARTNERS ATTORNEY FOR THE APPLICANT

Documents:

917-mumnp-2006-abstract(5-12-2007).doc

917-mumnp-2006-abstract(5-12-2007).pdf

917-mumnp-2006-abstract.doc

917-mumnp-2006-abstract.pdf

917-mumnp-2006-cancelled pages(5-12-2007).pdf

917-mumnp-2006-claims(granted)-(5-12-2007).doc

917-mumnp-2006-claims(granted)-(5-12-2007).pdf

917-mumnp-2006-claims.doc

917-mumnp-2006-claims.pdf

917-mumnp-2006-correspondance-recieved.pdf

917-mumnp-2006-correspondence(09-04-2008).pdf

917-mumnp-2006-correspondence(5-4-2008).pdf

917-mumnp-2006-correspondence(ipo)-(10-4-2008).pdf

917-mumnp-2006-description (complete).pdf

917-mumnp-2006-drawing(5-12-2007).pdf

917-mumnp-2006-form 1(1-8-2006).pdf

917-mumnp-2006-form 1(31-7-2006).pdf

917-mumnp-2006-form 18(1-8-2006).pdf

917-mumnp-2006-form 2(granted)-(5-12-2007).doc

917-mumnp-2006-form 2(granted)-(5-12-2007).pdf

917-mumnp-2006-form 26(5-12-2007).pdf

917-mumnp-2006-form 3(5-1-2007).pdf

917-mumnp-2006-form 3(5-12-2007).pdf

917-mumnp-2006-form-1.pdf

917-mumnp-2006-form-2.doc

917-mumnp-2006-form-2.pdf

917-mumnp-2006-form-3.pdf

917-mumnp-2006-form-5.pdf

917-mumnp-2006-pct-search-report.pdf

abstract1.jpg


Patent Number 220728
Indian Patent Application Number 917/MUMNP/2006
PG Journal Number 33/2008
Publication Date 15-Aug-2008
Grant Date 03-Jun-2008
Date of Filing 01-Aug-2006
Name of Patentee DEEPBREEZE LTD.
Applicant Address 2 HAILAN STREET, P.O. BOX 140, INDUSTRIAL PARK OR AKIVA 30600, ISRAEL
Inventors:
# Inventor's Name Inventor's Address
1 BOTBOL MEIR 7 NEVE HADARIM STREET, 37017 PARDES HANA, ISRAEL
2 KUSHNIR,Igal 11 Shkedim Street,37011 Pardes Hana,Israel
PCT International Classification Number A61B5/087
PCT International Application Number PCT/IL2005/000145
PCT International Filing date 2005-02-06
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 10/771,139 2004-02-04 U.S.A.