Multi-spirometer and method for measuring ventilatory function by spirometry

• US 20040260195A1
• Filed: 05/04/2004
• Published: 12/23/2004
• Est. Priority Date: 11/05/2001
• Status: Active Grant

• Current Assignee: Health Solutions
• Original Assignee: Health Solutions
• Inventors: Burrul, Francisco Cardona
• Granted Patent: US 7,291,115 B2
• Time in Patent Office: Days
• US Class Current: 600/538
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/0871 Peak expiratory flowmeters
• CPC Class Codes: A61B 5/09 using an element rotated by the flow toys actuated by air current A63H33/40
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity

Abstract

The function of the multispirometer and procedure to measure the ventilatory function by spirometry is to know how a person exhales or expels air with the objective to study and monitor the functioning of his/her lungs and many pathologies. By means of this method, the ventilatory function by spirometry is measured, and is capable of obtaining respiratory restriction and obstruction values of a patient. To perform the above mentioned method, an electronic spirometer provided with flow detector means, microprocessor control means to carry out calculations on the basis of measured data, and means associated to said microprocessor to store the measured results, to visualize the results and to compare the stored results, is used.

Claims

1. Method to measure the ventilatory function by spirometry, capable of obtaining respiratory restriction and obstruction values of a patient, by using an electronic spirometer provided with flow detector means, microprocessor control means to carry out calculations on the basis of measured data, and means associated to said microprocessor to store the measured results, to visualize the results and to compare the stored results, comprising the steps of:

entering data by means of said spirometer of a test consisting of a VC (vital capacity) maneuver, where from a maximal inspiration the subject has to exhale slowly until no more air can be expelled, and entering data by means of said spirometer of a FEV maneuver (forced expiratory volume during the first second) consisting of a forced and continuous exhalation from maximal inspiration, and exhaling the air until a minimum predetermined time has elapsed, and processing by computer means the expiration flow data obtained during the previously-mentioned two maneuvers by said microprocessor to obtain the main parameters and an evaluation of the ventilatory function and the respiratory condition of the patient.

2. Method, according to claim 1, wherein said minimum predetermined forced exhalation time in said FEV maneuver oscillates between 2.5 and 3.5 seconds.

3. Method, according to claim 2, wherein said forced exhalation time limit is indicated by means of an audible signal, such as a tone, or a light signal, at which time said forced expiration may be stopped.

4. Method, according to claim 1, wherein said test data entry comprising said VC maneuver and said FEV maneuver, further comprises conventional forced spirometry measurements or complete test with all the parameters and curves required by standard procedures.

5. Method, according to claim 1, wherein said data processing comprises calculation of a FEV maneuver index, referenced as IM, consisting of a 2-digit numerical expression based on the flow/time curve, which reflects the FEV maneuver performed by the patient, consisting in drawing a flow/time curve taking as the first digit of said index the time measurement in tenths of a second, from a maximum flow point until the first second of forced exhalation relative to the initial exhalation intensity of the patient, and as the second digit of said index the time in tenths of a second of a descending and concave curve viewed from above, from the maximum flow point until the first second of forced exhalation, relative to the intensity and the uniformity of the expiration of air during the first second;

the results being classified according to a weighted score from 99 to 00.

7. Method, according to claim 1, wherein said spirometer further comprises a screen, which shows, if each VC, FEV and FVC maneuvers performed is acceptable or not as per ATS criteria, including uniformity of volume/time curve for FEV and FVC, and the moment in which the test being carried out complies with ATS'"'"'s acceptability and reproducibility criteria, by means of a preset code or another audible or visual indication.

8. Method, according to claim 1, wherein personal VC and FEV values, that are absolute VC and FEV values obtained from an analysis supervised by a physician, when it is deemed that a patient is clinically and functionally stable, are introduced in memory, and in that a series of variability calculations are performed in relation to said personal VC and FEV values, taken as a reference, from data of subsequent measurements performed by the patient.

9. Method, according to claim 8, wherein said variability calculations with respect to said absolute personal VC and FEV values, taken as reference, allow expressing the results as a percentage of the normal reference value and as a percentage of the personal value.

10. Method, according to claim 8, wherein present measurement values are prepared by combining them with said personal VC and FEV values to provide a result as a percentage of said personal values.

11. Method, according to claim 8, wherein the present VC and/or FEV degree of alteration in relation to said personal VC and FEV is expressed as coded index indicating the respiratory status of the subject.

12. Method, according to claim 1, wherein the measured data and/or the result of the processing of each of said data entries is stored in different registration number options, which can be temporary, being erased manually, or temporary, being erased automatically, at a predetermined time, identifying the subject temporarily, and permanent, identifying the subject indefinitely.

16. Method, according to claim 5, wherein when entering personal VC and FEV values, the spirometer provides a personal FEV maneuver index (IMP), which indicates the own and optimum expiratory effort blow of a subject, and allows comparing said IM performed with said IMP.

17. Method, according to claim 5, wherein an average maneuver index corresponding to the average of all the registration number IM indices, serves as a guide for a period under study and provides an orientation of the degree of validity for said period.

18. Method, according to claim 5, wherein the IM maneuver index is shown in a screen of the spirometer immediately after each FEV maneuver.

19. Method, according to claim 4, wherein, in the complete test, the IM maneuver index is shown in a screen of the spirometer immediately after each FVC maneuver.

6. (Cancelled)

13. (Cancelled)

14. (Cancelled)

15. (Cancelled)

20. Spirometer with flow detector means, microprocessor controlled means to carry out calculations from measured data, and means associated to said microprocessor to store the measured results, to visualize the results and to compare the stored results comprising a plurality of keys (1) for the different test options, for the different registration number options, and for the possibility to set a registration number in each of the above options;

a screen 2 progressively lights up in function of the percentage of the normal (N) reference value chosen or the personal (P) value, both for VC in the VC maneuver, as well as FEV in FEV maneuver and the FVC maneuver; and

a plurality of lighted indicators (3) showing the results and respiratory status.

21. Spirometer, according to claim 20, wherein the plurality of keys (1) further comprises an option key (7), a registration number key (8), up and down keys (12), a enter key (13), keys (9, 20) used to perform a simple test (VC, FEV), keys (10) to perform a complete test (VC, FVC), a test number key (17), a print key (14), a transmit key (15), a save key (16), a VC personal key (18), a FEV personal key (19) and a plurality of keys (11) for entering the required data of age, height, sex and ethnic group.

22. Spirometer, according to claim 20, wherein the plurality of indicators (3) indicate whether there is restriction or obstruction and the intensity—

light, moderate, intense, severe or very severe, and, if personal values have been previously entered, the respiratory status as stable or indicating the degree of alteration.

23. Spirometer, according to claim 20, wherein sending remotely the results or indications obtained, for which purpose said spirometer is associated to means for remote transmission of results, such as a modem.

24. Spirometer, according to claim 20, wherein said flow detection means are of turbine and open circuit type.

25. A method for measuring ventilatory function and specifically for obtaining respiratory restriction and obstruction values of a patient comprising the steps of:

using an electronic spirometer having flow detector means, microprocessor control means to carry out calculations on the basis of measured data, and means associated with said microprocessor for storing the measured results, for visualizing the results, and for comparing the stored results;

data entry by means of said spirometer, said data being obtained by a first test comprising a VC (vital capacity) maneuver, where from a maximal inspiration said patient exhales slowly until no more air can be expelled; and

by a second test comprising a FEV maneuver (forced expiratory volume during the first second) consisting of a forced and continuous exhalation from maximal inspiration, and exhaling the air until a minimum predetermined time has elapsed;

processing, by computer means, the expiration flow data obtained during said VC and FEV maneuvers; and

obtaining the main parameters and an evaluation of the ventilatory function and the respiratory condition of the patient.