Metered dose inhaler biofeedback training and evaluation system

• US 4,984,158 A
• Filed: 10/14/1988
• Issued: 01/08/1991
• Est. Priority Date: 10/14/1988
• Status: Expired due to Fees

• Current Assignee: Sierra Technology LLC
• Original Assignee: Lowell G. Wise
• Inventors: Hillsman, Deane
• Primary Examiner(s): Smith, Jerry
• Assistant Examiner(s): Huntley, David
• Application Number:
  US07/257,550
• Time in Patent Office: 816 Days
• Field of Search: 128/725, 128/200.14, 128/200.23, 128/905, 364/413.03, 364/413.04
• US Class Current: 128/200.14
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal

Abstract

A visual and auditory biofeedback system instructs patients in proper techniques of inhalation to administer aerosol drugs with Metered Dose Inhaler (MDI) devices. The system displays desired respiratory parameters along with real time performance with computer related technology means. Optimal performance parameters suited to individual patient needs may be generated. Suitable respiratory flow transducer means is used to generate air volume signals in real time, and suitable electronic switching means is used to indicate MDI activation in real time. Optional auditory incentive means are provided. Optional plus and minus error limits of acceptable performance are provided.

The system thus provides visual and auditory biofeedback incentives to improve patient or student performance to mechanical prescription parameters defined by the physician or instructor. Performance deficiency and performance enhancement indicators may be optionally used, both to enhance and to quality control performance. Performance records may be saved by suitable electronic means or hard copy for clinical or research needs.

In the preferred embodiments of the invention, the system may be implemented in either a suitable general purpose digital computer or similar specialized stand-alone computer related devices.

Claims

1. Inhalation therapy apparatus for enhancing patient performance during inhalation of aerosol treatment materials comprising:

airflow conduit means for receiving inspiration and expiration air from the patient;

manually activated means for introducing a metered dose of aerosol treatment material or placebo substitute into the airflow conduit means;

means for measuring patient inspiration and expiration airflow and generating a first signal representative of said airflow;

means for determining a cyclic expiration point representative of lung exhaustion and generating a second signal upon lung exhaustion;

dosage signal means responsive to said second lung exhaustion signal to indicate to the patient to begin an inspiration cycle and substantially simultaneous manual activation of said manually activated means;

means for indicating completion of air intake in said inspiration cycle and manual activation of said manually activated means; and

means for indicating to the patient a prescribed inhalation airflow pattern.

2. A training method for teaching inhalation drug administration to a human subject comprising the steps of:

measuring normal subject respiration in an airflow conduit operatively connected to the subject'"'"'s respiration passages, an airflow bi-directional flow sensor and an aerosol material supply;

generating a signal representative of subject normal resting respiratory airflow;

integrating the airflow signal to provide a real time tidal volume signal;

visually displaying the tidal volume signal in a time axis volumetric display;

determining normal lung expiration level and full normal inspiration volume for at least one subject'"'"'s resting respiratory cycle;

determining in a subsequent respiration cycle when the subject'"'"'s lung expiration level is achieved below the predetermined normal resting expiration level;

initiating a dosage cycle by transmitting to the subject a command signal to manually activate flow of aerosol material from the aerosol supply into the airflow conduit, and;

visually displaying to the subject during the dosage cycle a prescribed tidal volume inspiration-expiration flow pattern, thereby permitting controlled introduction of the aerosol material with a predetermined inspiration volume and flow rate and affecting deposition of aerosol material in the subject'"'"'s lung during the dosing cycle prior to expiration.

3. The method of claim 2 wherein said prescribed inspiration - expiration flow pattern includes a time delay at approximately full inspiration volume prior to expiration.

4. The method of claim 2 wherein normal resting respiration is displayed on first display screen and dosage cycle respiration is displayed on a second screen.

5. The method of claim 2 further including the steps of:

detecting initiation of dosage cycle inspiration and resetting the prescribed tidal volume flow pattern;

comparing the real time tidal volume signal with the the prescribed tidal volume flow pattern correlated with inspiration reset; and

visually displaying the real time tidal volume signal and the prescribed tidal volume flow pattern in visually discernable superimposed observation modes.

6. A system for sensing and displaying in real time a variable analog function representative of respiration air flow for visual comparison with a predetermined dosing cycle analog function representative of an optimal prescribed respiration condition, comprising:

means for generating an analog signal representative of the variable analog function;

display means for visual display of said variable analog function and said predetermined dosing cycle analog function, having scanning means with a predetermined frame time, a scanning beam and having a predetermined scan raster and frame;

means for determining a normal expiration volume;

means for generating a prompt signal when said normal expiration volume is exceeded beyond a predetermined volume;

first memory means for storing said predetermined dosage cycle analog function as a waveform;

means for providing and storing digital signals representative of the variable analog function in second memory means;

metered dose cycle initiation means, manually actuated in response to said prompt signal;

manually actuated means for reading out each of said first memory means and second memory means in timed relation to the scan rate of said display means, and;

means for generating a display in said display means when a value read out from either of said first and second memory means corresponds to a current scanned position of said display means.

7. The system of claim 6 wherein each of said first memory means and second memory means comprise digital memories;

said first memory means storing digital sample values of said predetermined analog waveform; and

said system further including means for integrating said sensed analog signal and means for generating digital sample values of said integrated signal at a time rate synchronized with the line rate of scan of said display means.

8. The system of claim 7 further comprising:

multiplexing means for storing successive digital sample values in corresponding successive storage positions of said second memory means at a first rate related to a respiration time cycle of said variable analog function and for reading out digital values in alternating succession from each of said first and second memory means at a second rate related to the rate of scanning each successive line of said display means;

counter means for accumulating a count corresponding to the number of lines scanned in a given raster scan of said display means; and

comparator means for comparing the digital value read from either of said first and second memories under control of said multiplexing means with the line count of said line counter means for producing a video display output when said digital line count corresponds to said digital value read from said first or second memory means.

9. The system of claim 8 comprising:

a first digital-to-analog converter for converting the digital value of the predetermined analog waveform read from said first memory means to a corresponding analog signal;

a second digital-to-analog converter for converting the digital sample values of said variable analog waveform read from said second memory means; and

first signal comparator means for producing an output representing a predetermined difference between the said analog outputs of said first and second digital-to-analog converters.

10. The system of claim 6 wherein said first memory means includes a digital read only memory or appropriately partitioned random access memory, and said second memory means includes a digital random access memory.

11. A real time biological performance evaluation and metered dose training device which comprises:

means for measuring normal resting respiratory air flow and generating a flow signal representative of said air flow;

means for integrating said air flow signal with relation to a time base and generating a volumetric signal representative of the integrated air flow;

means for detecting a predetermined lung exhalation volume and initiating an ideal volumetric respiration pattern concurrently with a prompt signal;

manually actuated means for introducing a metered dose of aerosol material into inspiration airflow;

means for comparing the volumetric signal with the ideal volumetric respiration pattern; and

means for visually displaying the volumetric signal and ideal pattern in visually discernible superimposed observation modes on a dynamic display.

12. A device according to claim 11 further comprising means for presetting performance error limits and providing visual and auditory performance deficiency signals.

13. A device according to claim 11 further comprising means for displaying on the ideal respiration pattern a blinking dot in a predetermined time domain to precisely prompt the subject performance.

14. The device according to claim 11 further comprising means for activating auditory and visual alarms in response to predetermined deviation of the volumetric signal from the ideal pattern.

15. The device according to claim 11 comprising means for adjusting positive and negative error limits and means for detecting and indicating volumetric signals in relation to time parameters outside said error limits.

16. Inhalation therapy apparatus for enhancing patient performance during inhalation of aerosol treatment materials comprising:

airflow conduit means for receiving inspiration and expiration air from the patient;

manually actuated means for introducing a metered dose of aerosol material into the airflow conduit means;

means for generating a first signal representative of airflow;

means for indicating a cyclic expiration point representative of lung exhaustion;

dosage signal means for indicating to the patient beginning of an inspiration cycle and substantially simultaneous manual activation of said manually activated means; and

means for indicating completion of air intake in said inspiration cycle and manual actuation of said manually actuated means.