Spirometer and method to measure the ventilatory function by spirometry

• US 7,291,115 B2
• Filed: 11/05/2001
• Issued: 11/06/2007
• Est. Priority Date: 11/05/2001
• Status: Expired due to Fees

• Current Assignee: Health Solutions
• Original Assignee: Health Solutions
• Inventors: Cardona Burrul, Francisco
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US10/494,443
• Publication Number:
  US 20040260195A1
• Time in Patent Office: 2,192 Days
• Field of Search: 600529-543
• 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 of measuring the ventilatory function of a patient including obtaining respiratory restriction and obstruction values of a patients by spirometry 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 with said microprocessor to store the measured results, and to visualize the results and compare the stored results, said method comprising the steps of:

capturing data by means of said spirometer of a test consisting of a VC (vital capacity) maneuver, where from a maximal inhalation the subject has to exhale slowly until no more air can be expelled;

capturing data by means of said spirometer of a FEV maneuver consisting of a forced and continuous exhalation from maximal inhalation, and exhaling the air until at least one second has already lapsed;

processing the expiration flow data obtained during the previously-mentioned maneuvers by said microprocessor to obtain main parameters and an evaluation of the ventilatory function and the respiratory condition of the patient; and

wherein said data processing step comprises calculating an FEV maneuver index (IM) consisting of a 2-digit numerical expression based on the flow/time curve, which reflects the FEV maneuver performed by the patient, which includes 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 descending and concave portions of a 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.

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 1, wherein said forced exhalation time limit is indicated by means of a signal at which time said forced expiration may be stopped.

4. Method, according to claim 1, further comprising the step of capturing by means of said spirometer conventional forced spirometry measurements or complete test with all the parameters and curves required by standard procedures.

5. Method, according to claim 4, further comprising the step of performing an FVC (forced vital capacity) maneuver, wherein said spirometer further comprises a screen, which shows if each VC, FEV and FVC maneuvers performed is acceptable as per a predetermined set of criteria, including uniformity of volume/time curve for FEV and FVC, and wherein said method further comprises indicating the moment in which the test being carried out complies with said predetermined set of criteria as far as acceptability and reproducibility, by means of a preset code or another audible or visual indication.

6. Method, according to claim 1, further comprising the steps of:

inputting into memory personal VC and FEV reference values obtained from an analysis supervised by a physician, when it is deemed that a patient is clinically and functionally stable, and

performing a series of variability calculations in relation to said personal VC and FEV reference values from data of subsequent measurements performed by the patient.

7. Method, according to claim 6, wherein said variability calculations with respect to said personal VC and FEV reference values allow expressing the results as a percentage of a normal reference value corresponding to age, weight, height, sex, and ethnicity of the patient and as a percentage of the personal reference value.

8. Method, according to claim 6, wherein present measurement values are prepared by combining them with said personal VC and FEV reference values to provide a result as a percentage of said personal reference values.

9. Method, according to claim 6, wherein the present VC and/or FEV degree of alteration in relation to said personal VC and FEV reference values is expressed as coded index indicating the respiratory status of the subject.

10. 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.

11. Method, according to claim 1, further comprising the step of entering personal VC and FEV reference values obtained from an analysis supervised by a physician, when it is deemed that a patient is clinically and functionally stable, and wherein the spirometer provides a personal FEV maneuver index (IMP), which indicates the actual and optimum expiratory effort blow of a subject, and allows comparing said IM performed with said IMP.

12. Method, according to claim 10, 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.

13. Method, according to claim 1, wherein the IM maneuver index is shown on a screen of the spirometer immediately after each FEV maneuver.

14. Method, according to claim 5, wherein the IM maneuver index is shown on said screen of the spirometer immediately after each FVC maneuver.

15. Spirometer comprising:

flow detector means effective to measure Vital Capacity (VC) from a VC maneuver and Forced Expiratory Volume during the first second (FEV) of an FEV maneuver, wherein said flow detection means are of turbine and open circuit type,

microprocessor controlled means to carry out calculations from measured data, and

means associated with said microprocessor to store the measured results, to visualize the results, and to compare the stored results, said means associated with said microprocessor comprising

a plurality of keys 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 that progressively lights up to indicate function of the percentage of a predetermined normal reference value or a personal reference value obtained from an analysis supervised by a physician, when it is deemed that a patient is clinically and functionally stable, said predetermined normal reference value and said personal reference value are for VC in the VC maneuver, as well as FEV in FEV maneuver and FVC in an FVC maneuver, and

a plurality of lighted indicators showing the results and respiratory status, where the indicators 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.

16. Spirometer, according to claim 15, wherein the plurality of keys further comprises an option key, a registration number key, up and down keys, a enter key, keys used to perform a simple test (VC, FEV), keys to perform a complete test (VC, FVC), a test number key, a print key, a transmit key, a save key, a VC personal key, a FEV personal key and a plurality of keys for entering the required data of age, height, sex and ethnic group.

17. Spirometer, according to claim 15, wherein said spirometer is associated with means for remote transmission of results.

18. 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;

wherein said procession step comprises calculating an FEV maneuver index (IM) consisting of a 2-digit numerical expression based on the flow/time curve, which reflects the FEV maneuver performed by the patient, which includes 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 descending and concave portions of a 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;

and

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