Drug delivery apparatus

• US 6,584,971 B1
• Filed: 06/30/2000
• Issued: 07/01/2003
• Est. Priority Date: 01/04/1999
• Status: Expired due to Term

• Current Assignee: Caterpillar Incorporated, Profile Respiratory Systems Limited (Koninklijke Philips N.V.)
• Original Assignee: Medic-Aid Limited (Koninklijke Philips N.V.)
• Inventors: Prince, Ivan Richard, Denyer, Jonathan Stanley Harold, Dyche, Anthony
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/608,662
• Time in Patent Office: 1,096 Days
• Field of Search: 128/200-4-2, 128/203.12, 128/203.14, 128/203.23, 128/203.24, 128/203.25
• US Class Current: 128/203.14
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

A nebulizer has structure for determining the duration of a pulse of atomization during inspiration, the determination structure including components for measuring the tidal volume of a patient, measuring the duration of inspiration, for storing estimates of the volume of a patient'"'"'s upper airway, and for calculating the duration of the pulse. The duration of the pulse is calculated on the basis of the tidal volume, the duration of inspiration, and the stored estimated volume of patient'"'"'s upper airway.

Claims

1. A drug delivery apparatus comprising:

a) a drug delivery device for selectively delivering both medication-laden air and non-medicated air to a patient for inspiration, wherein the medication-laden air is selected to be delivered in pulses;

b) a sensor for monitoring a patient'"'"'s breathing pattern; and

c) a controller for controlling the drug delivery device to deliver the medication in pulses;

wherein the length of the pulses and the proportion of time of the inspiratory phase of the breathing pattern during which the pulse is delivered are varied by the controller depending on the breathing pattern monitored by the sensor.

2. A drug delivery apparatus according to claim 1, wherein the apparatus is a nebulizer in which the drug delivery device is a device for atomizing a medication, and the controller controls the atomizing device to atomize the medication in pulses.

3. A nebulizer according to claim 2, wherein the controller which determines the duration of the pulse of atomization includes a tidal volume measuring device for measuring the tidal volume of a patient, a timer for measuring the duration of inspiration, an estimate storage device for storing an estimate of the volume of a patient'"'"'s upper airway, and a pulse length calculator for calculating the duration of the pulse on the basis of the tidal volume measured by the tidal volume measuring device, the duration of inspiration measured by the timer, and the stored estimated volume of a patient'"'"'s upper airway from the storage device.

4. A nebulizer according to claim 3, wherein the tidal volume measuring device includes a peak flow detector for measuring a patient'"'"'s peak flow, and a tidal volume predictor for calculating the tidal volume on the basis of the peak flow measured by the peak flow detector, and the duration of inspiration measured by the timer.

5. A nebulizer according to claim 3, wherein the duration of the pulse is calculated on the basis of mean values of measured tidal volume and measured duration of inspiration derived from a number of earlier measurements of the breathing pattern of the patient.

6. A nebulizer according to of claim 2, further comprising a source of pressurised gas for atomizing the medication, the source including an accumulator for accumulating the gas under pressure, and a pulse limiter for limiting the duration of the pulse so as to maintain the accumulator in a state where it is always under some pressure.

7. A nebulizer according to claim 6, wherein the accumulator includes a valve which, when the accumulator is full, vents gas to atmosphere.

8. A drug delivery apparatus according to claim 1, wherein the apparatus is a spacer in which the delivery device for selectively delivering medication-laden air is a container defining a holding chamber for holding medication-laden air.

9. A drug delivery apparatus according to claim 8, wherein the controller, which determines the duration of the pulse, includes a tidal volume measuring device for measuring the tidal volume of a patient, a timer for measuring the duration of inspiration, an estimate storage device for storing an estimate of the volume of a patient'"'"'s upper airway, and a pulse length calculator for calculating the duration of the pulse on the basis of the tidal volume measured by the tidal volume measuring device, the duration of inspiration measured by the timer, and the stored estimated volume of a patient'"'"'s upper airway from the storage device.

10. A drug delivery apparatus according to claim 9, wherein the tidal volume measuring device includes a peak flow detector for measuring a patient'"'"'s peak flow, and a tidal volume predictor for calculating the tidal volume on the basis of the peak flow measured by the peak flow detector, and the duration of inspiration measured by the timer.

11. A drug delivery apparatus according to claim 9, wherein the duration of the pulse is calculated on the basis of mean values of measured tidal volume and measured duration of inspiration derived from a number of earlier measurements of the breathing pattern of the patient.

12. A drug delivery apparatus according to claim 8, wherein the container defining the holding chamber includes at least one wall which is adjustable to reduce the volume of medication-laden air in the holding chamber to permit the medication-laden air to be delivered to a patient.

13. A drug delivery apparatus according to claim 8, wherein the container defining the holding chamber includes a piston moveable within the holding chamber to reduce the volume of medication-laden air in the holding chamber to permit the medication-laden air to be delivered to a patient.

14. A drug delivery apparatus according to claim 13, further comprising a piston controller for controlling the movement of the piston to deliver medication-laden air in pulses.

15. A drug delivery apparatus according to claim 8, further comprising a vent which allows inspiration of ambient air not laden with medication outside of the time in which a pulse is present.

16. A drug delivery apparatus according to claim 1, wherein the drug delivery device includes:

a spacer defining a holding chamber; and

a nebulizer for atomizing the medication into the holding chamber;

wherein the controller controls the atomizer to atomize the medication in pulses.

17. A drug delivery apparatus according to claim 16, wherein the spacer includes an inhalation valve through which air enters the holding chamber to replace air inhaled from the holding chamber.

18. A drug delivery apparatus according to claim 16, further comprising a sensor arranged to detect the concentration of atomized medication within the holding chamber.

19. A nebulizer comprising apparatus for determining the duration of a pulse of atomization during inspiration, the apparatus including a tidal volume measuring device for measuring the tidal volume of a patient, a timer for measuring the duration of inspiration, an estimate storage device for storing an estimate of the volume of a patient'"'"'s upper airway, and a calculator for calculating the duration of the pulse on the basis of the tidal volume measured by the tidal volume measuring device, the duration of inspiration measured by the timer, and the stored estimated volume of a patient'"'"'s upper airway from the storage device.

20. A nebulizer according to claim 19, wherein the tidal volume measuring device includes a peak flow detector for measuring a patient'"'"'s peak flow, and a tidal volume predictor for calculating the tidal volume on the basis of the peak flow measured by the peak flow detector, and the duration of inspiration measured by the timer.

21. A nebulizer according to claim 19, wherein the duration of the pulse is calculated on the basis of mean values of measured tidal volume and measured duration of inspiration derived from a number of earlier measurements of the breathing pattern of the patient.

22. A nebulizer according to claim 19, further comprising a container which defines a holding chamber, the container including at least one wall which is adjustable to reduce a volume of medicated air in the holding chamber to permit the medicated air to be delivered to a patient.

23. A nebulizer according to claim 19, wherein the container defining the holding chamber includes a piston moveable within the holding chamber to reduce a volume of medication-laden air in the holding chamber to permit the medication-laden air to be delivered to a patient.

24. A nebulizer according to claim 23, further comprising a piston controller for controlling the movement of the piston to deliver medication-laden air in pulses.

25. A nebulize according to claim 19, further comprising a vent which allows inspiration of ambient air not laden with medication outside of the time in which a pulse is present.

26. A nebulizer comprising:

an atomizing device for atomizing a medication;

a sensor for monitoring a patient'"'"'s breathing pattern; and

a controller for controlling the atomizing device to atomize the medication in pulses, wherein the length of the pulses and the proportion of time of the inspiration phase of the breathing pattern during which the pulse is delivered are varied by the controller depending on the breathing pattern monitoring by the sensor.

27. A method for determining the duration of a pulse during which medicated air is delivered to a patient during inspiration, comprising:

(i) measuring the tidal volume of a patient;

(ii) measuring the duration of inspiration of a patient;

(iii) storing an estimate of the volume of a patient'"'"'s upper airway; and

(iv) calculating the duration of the pulse on the basis of the measured tidal volume of the patient, the measured duration of the inspiration and the stored estimated volume of the patient'"'"'s upper airway.

28. A method according to claim 27, wherein the measurement of the tidal volume of a patient comprises:

(v) measuring the peak flow of a patient; and

(vi) predicting the patient'"'"'s tidal volume on the basis of the measured peak flow and the measured duration of inspiration.

29. A method according to claim 27, wherein calculations are carried out on mean values derived from a number of earlier measurements of the breathing pattern of the patient.

30. A method according to claim 27, in which the pulse is a pulse of atomization of a medication whereby medication-laden air is delivered to a patient.

31. Drug delivery apparatus comprising a tidal volume predictor for predicting the tidal volume of a patient, including a detector for measuring a patient'"'"'s peak flow, a timer for measuring the duration of inspiration, and a tidal volume calculator for calculating the tidal volume on the basis of the peak flow from the peak flow detector, and the duration of inspiration measured by the timer.

32. An apparatus according to claim 31, wherein the tidal volume is calculated on the basis of mean values of measured peak flow and measured duration of inspiration derived from a number of earlier measurements of the breathing pattern of the patient.

33. Apparatus according to claim 31, wherein the apparatus is a nebulizer.

34. A method of predicting the tidal volume of a patient comprising:

(i) measuring a patient'"'"'s peak flow;

(ii) measuring the duration of inspiration of a patient;

(iii) calculating the tidal volume on the basis of the measured peak flow and the measured duration of inspiration of the patient.

35. A method according to claim 34, wherein calculations are carried out on mean values derived from a number of earlier measurements of the breathing pattern of the patient.