Method for releasing controlled amount of aerosol medication

• US 5,608,647 A
• Filed: 09/08/1995
• Issued: 03/04/1997
• Est. Priority Date: 03/05/1991
• Status: Expired due to Term

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Rubsamen, Reid M., Johansson, Eric T.
• Primary Examiner(s): Cosimano, Edward R.
• Application Number:
  US08/525,838
• Time in Patent Office: 543 Days
• Field of Search: 128/204.18, 128/204.21, 364/178, 364/509, 364/510
• US Class Current: 700/281
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• 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 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: B01F 23/2132 using nozzles
• CPC Class Codes: B01F 35/712 : for feeding fluids
• CPC Class Codes: B01F 35/7179 : using sprayers, nozzles or jets
• CPC Class Codes: B01F 35/71805 : using valves, gates, orifices or openings
• CPC Class Codes: B01F 35/7547 : using valves, gates, orifices or openings
• CPC Class Codes: F16H 35/00 : Gearings or mechanisms with other special functional features
• CPC Class Codes: G01F 1/363 : with electrical or electro-mechanical indication G01F1/37 and G01F1/38 take precedence
• CPC Class Codes: G01F 1/40 : Details of construction of the flow constriction devices
• CPC Class Codes: G01F 1/44 : Venturi tubes
• CPC Class Codes: G01F 1/50 : Correcting or compensating means
• CPC Class Codes: G01F 13/006 : measuring volume in function of time
• CPC Class Codes: G01F 15/002 : for gases
• CPC Class Codes: G01F 25/10 : of flowmeters
• CPC Class Codes: G01F 7/005 : by measuring pressure or differential pressure, created by the use of flow constriction

Abstract

A method for releasing a controlled amount of aerosol medication is disclosed. The method of the invention is preferably used in connection with a portable, battery-powered, hand-held system for releasing a controlled dose of aerosol medication for inhalation by a patient. The inhalation breath flow of the user of the apparatus is monitored and the inhalation flow rate is measured, and inhalation volume is determined as a function of the measured flow rate. The measured flow rate is compared to predetermined minimum and maximum flow rate thresholds, and the determined flow volume is compared to predetermined minimum and maximum flow volume thresholds. When both the measured flow rate and the measured flow volume are between their respective the minimum and maximum thresholds, a signal is provided to release a controlled amount of aerosol.

Claims

1. A method for releasing a controlled amount of aerosol medication from a valved canister containing the medication for intrapulmonary delivery to a person during inhalation breath flow comprising the steps of:

a) monitoring the inhalation breath flow through a flow path and determining the beginning and the end of the inhalation;

b) measuring the flow rate of the sensed inhalation breath flow;

c) determining the flow volume of the inhalation breath flow as a function of the measured flow rate;

d) providing a flow rate minimum threshold and a flow rate maximum threshold and providing a minimum flow volume threshold and a maximum flow volume threshold;

e) comparing the measured flow rate to the minimum flow rate threshold and the maximum flow rate threshold;

f) comparing the determined flow volume to the minimum flow volume threshold and the maximum flow volume threshold, said comparing the determined flow volume being performed when the determined flow rate is between the minimum and maximum flow rate thresholds;

g)

i) releasing a controlled amount of medication when the determined flow volume is between the minimum and maximum flow volume thresholds,

ii) declaring a failed breath event if the inhalation has ended and the determined flow volume is not between the minimum and maximum flow volume thresholds, or

iii) returning to step (a) if the inhalation has not ended and the determined flow volume is not between the minimum and maximum flow volume thresholds.

2. The method of claim 1 wherein step (e) further comprises determining whether the measured flow rate exceeds the minimum flow rate threshold and declaring a failed breath event if the inhalation has ended and the measured flow rate did not exceed the minimum flow rate threshold.

3. The method of claim 1 where in step (d) further comprises providing a minimum flow rate threshold on the order of 40 liters per minute and a maximum flow rate threshold on the order of 80 liters per minute.

4. The method of claim 1 wherein step (d) further comprises providing a minimum flow volume threshold on the order of 1.0 liters and a maximum flow volume threshold on the order of 1.25 liters.

5. The method of claim 1 further comprising maintaining a record of the number of controlled amounts of medication released.

6. The method of claim 1 further comprising maintaining a record of the number of controlled amounts of medication remaining in the canister.

7. The method of claim 1 wherein step (b) further comprises:

sensing the pressure of flow in the flow path using a pressure transducer;

converting the sensed pressure for an inhalation flow into a corresponding voltage signal;

determining whether the flow corresponds to an inhalation; and

determining a flow rate for the sensed pressure as a function of i) the converted voltage, ii) a predetermined calibration array of a plurality of discrete known flow rates having corresponding known voltage signals, and iii) piecewise linear interpolation.

8. The method of claim 7 wherein converting the voltage further comprises i) converting the voltage to a digital value using an analog to digital converter, ii) measuring the drift offset of the pressure transducer and adjusting the digital value by the measured drift offset to produce a corrected digital value, and iii) providing the corrected digital value as the converted voltage.

9. The method of claim 1 wherein step (b) further comprises measuring the peak flow rate during the sensed breath inhalation, step (c) further comprises determining the total inhaled volume during the sensed inhalation, and the method further comprises

(h) adjusting the minimum flow rate threshold and the minimum flow volume threshold in response to a declared failed breath event as respective functions of the measured peak flow rate and the determined total flow volume for use in steps (e) and (f) for the next sensed breath inhalation.

10. The method of claim 9 further comprising

(i) adjusting the maximum flow rate threshold and the maximum flow volume threshold in response to a declared failed breath event as respective functions of the measured peak flow rate and the determined total flow volume for use in steps (e) and (f) for the next sensed breath inhalation.

11. The method of claim 10 wherein the respective functions further comprise multiplying the determined peak flow rate by a first constant to provide the adjusted maximum rate and multiplying the determined total flow volume by a second constant to provide the adjusted maximum flow volume.

12. The method of claim 9 wherein the respective functions further comprise multiplying the determined peak flow rate by a first fraction to provide the adjusted minimum flow rate and multiplying the determined total flow volume by a second fraction to provide the adjusted minimum flow volume.

13. The method of claim 12 wherein the first fraction is 75% and the second fraction is 75%.

14. The method of claim 12 wherein adjusting the minimum flow rate threshold further comprises:

comparing the adjusted flow rate threshold to a first rate value corresponding to a default minimum flow rate threshold;

providing the adjusted flow rate threshold as the minimum flow rate threshold if the adjusted flow rate is less than the first rate value and providing the first rate value as the minimum flow rate threshold if the adjusted flow rate threshold is greater than the first rate value;

comparing the adjusted flow volume threshold to a first volume corresponding to a default minimum volume threshold; and

providing the adjusted flow volume threshold as the minimum flow volume threshold if the adjusted flow volume threshold is less than the first volume value and providing the first volume value as the minimum volume threshold if the adjusted flow volume threshold is greater than the first volume threshold.

15. A method for releasing a controlled amount of aerosol medication from a canister for intrapulmonary delivery to a person during inhalation comprising:

a) monitoring the inhalation breath flow through a tube;

b) measuring the flow rate of the sensed inhalation;

c) determining the volume of the sensed inhalation as a function of the measured flow rate;

d) providing a flow rate minimum threshold, a flow rate maximum threshold, a flow volume minimum threshold and a flow rate maximum threshold;

e) comparing the measured flow rate to the minimum and maximum flow rate thresholds;

f) comparing the determined flow volume to the maximum and minimum flow volume thresholds; and

g) providing a trigger signal for releasing a controlled amount of aerosol when the measured flow rate is between the minimum and maximum flow rate threshold and, at the same time, the determined flow volume is between the minimum and maximum flow volume thresholds.

16. The method of claim 15 wherein step (e) is performed prior to performing step (f), step further comprising:

i) determining whether or not the measured flow rate exceeds the minimum flow rate threshold, and ii) not performing step (g) if the measured flow rate does not exceed the minimum flow rate threshold during the inhalation.

17. The method of claim 16 wherein step (e) is performed prior to performing step (f), step (e) further comprising determining whether or not the measured flow rate is between the minimum and maximum flow rate thresholds and performing step (f) in response to the measured flow rate being between the minimum and maximum flow rate thresholds, and wherein step (g) further comprises determining whether or not the sensed inhalation has ended and i) returning to step (a) if the sensed inhalation has not ended and the trigger signal is not provided, or (ii) declaring a failed breath event if the sensed inhalation has ended and the trigger signal is not provided.