Dosimetric spacer for calculating dosage administered

• US 5,842,468 A
• Filed: 07/14/1997
• Issued: 12/01/1998
• Est. Priority Date: 10/27/1994
• Status: Expired due to Term

• Current Assignee: Profile Drug Delivery Limited (Koninklijke Philips N.V.)
• Original Assignee: Astra AB (Astrazeneca PLC), Medic-Aid Limited (Koninklijke Philips N.V.)
• Inventors: Nikander, Kurt Verner Holger, Denyer, Jonathan Stanley Harold
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/817,950
• Time in Patent Office: 505 Days
• Field of Search: 128/202.22, 128/203.12, 128/200.23, 128/200.14, 128/205.23
• US Class Current: 128/200.23
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0088 with variable volume
• 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 2016/0015 inhalation detectors
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

An apparatus for administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising a holding member (1) for temporarily holding the medicament and gas prior to inhalation, means for introducing a quantity of the medicament into the holding chamber (1), a sensor (4) for detecting the introduction of the medicament into the holding chamber (1), detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber (1) and calculation means (25, 27, 29, 30, 31) operably connected to the sensor (4) and to the detector means for calculating the amount of medicament received by a patient. The calculating means (25, 27, 29, 30, 31) makes its calculation on the basis of the quantity of medicament released into the holding chamber (1), the volume of the holding chamber (1), the time elapsed from the detection of the introduction of the medicament, and the detected rate of flow of gas inhaled from the holding chamber (1). The calculation being made by assessing the concentration of the medicament in the holding chamber (1) on a time basis during reduction of the said concentration within the holding chamber (1), and be determining the volume of the gas received by the patient during inhalation, and the time elapsed from the detected introduction of medicament to the inhalation by the patient.

Claims

1. Apparatus for administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising

a holding chamber for temporarily holding the medicament and gas prior to inhalation;

means for introducing a quantity of the medicament into the holding chamber;

a sensor for sensing the introduction of the medicament into the holding chamber;

detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber; and

calculation means operably connected to the sensor and to the detector means for calculating the amount of medicament received by a patient on the basis of;

the preset quantity of medicament released into the holding chamber;

of the preset volume of the holding chamber;

the time elapsed from the sensing of the introduction of the medicament;

and of the detected rate of flow of gas inhaled from the holding chamber;

the calculation being made by assessing the concentration of the medicament in the holding chamber on a time basis during reduction of the said concentration within the holding chamber due at least in part to deposition of the medicament within the holding chamber, and by determining the volume of the gas received by the patient during inhalation, and the time elapsed from the sensed introduction of medicament to the inhalation by the patient.

2. Apparatus according to claim 1 including indication means for indicating that the measured dosage has been administered.

3. Apparatus for administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising

a holding chamber for holding the medicament and gas prior to inhalation;

means for introducing a quantity of the medicament into the holding chamber;

a sensor for sensing introduction of the medicament into the holding chamber;

detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber; and

calculation means operably connected to the sensor and to the detector means for calculating the amount of medicament received by a patient, the calculation means including

a timing means for indicating the time elapsed since the sensor senses the introduction of medicament into the holding chamber;

means for supplying the initial concentration of medicament in the holding chamber immediately after the introduction of medicament therein;

means for determining the concentration of medicament in the holding chamber during inhalation by the patient, the concentration of medicament reducing with time due at least in part to deposition of the medicament within the holding chamber, the determination being made on the basis of the initial concentration supplied by the means for supplying initial concentration, and of the time elapsed since the sensor sensed the introduction of medicament into the holding chamber; and

means for determining the amount of medicament received by the patient by calculating the volume of gas inhaled by the patient from the holding chamber by integrating the rate of flow detected by the detector means, and by multiplying the calculated volume of gas by the concentration of medicament in the holding chamber at that time determined by the means for determining the concentration of medicament.

4. Apparatus according to claim 3 including a memory for storing a look-up chart showing the decrease of concentration of the medicament in the holding chamber over time.

5. Apparatus according to claim 4 wherein the means for determining the concentration of medicament in the holding chamber during inhalation makes the said determination also on the basis of the look-up chart in the memory.

6. Apparatus according to claim 3 wherein the means for supplying initial concentration of medicament in the holding chamber immediately after the introduction of medicament determines the said initial concentration on the basis of a preset quantity of medicament introduction into the holding chamber, and of a preset volume of the holding chamber.

7. Apparatus according to claim 3 wherein the holding chamber includes an inlet for permitting entry of gas into the holding chamber as gas is drawn out of the holding chamber by inhalation thereby causing a reduction of the concentration of medicament within the holding chamber by dilution.

8. Apparatus according to claim 7 wherein the means for determining the concentration of medicament in the holding chamber during inhalation makes the said determination also on the basis of the volume of gas previously inhaled by the patient.

9. Apparatus according to claim 7 including a memory for storing a look-up chart showing the decrease of concentration of the medicament in the holding chamber with the volume of air inhaled.

10. Apparatus according to claim 3 wherein the holding chamber includes a piston for reducing the volume of gas in the holding chamber as gas is inhaled, thereby preventing dilution.

11. Apparatus according to claim 10 including means for locking the piston.

12. Apparatus according to claim 11 wherein the means for locking the piston locks the piston upon administration of the measured dose.

13. Apparatus according to claim 10 wherein the piston is movable within the holding chamber for drawing gas and medicament into the holding chamber.

14. Apparatus according to claim 3 including a port in the holding chamber through which a quantity of medicament is introduced into the holding chamber by said releasing means, and through which gas is inhaled by a patient.

15. Apparatus according to claim 3 wherein the medicament is a cloud of liquid droplets.

16. Apparatus according to claim 3 wherein the medicament is a cloud of dry powder particles.

17. Apparatus according to claim 3 wherein the holding chamber includes a port through which the gas disposed in the chamber is inhaled, and through which the medicament is released into the holding chamber.

18. Apparatus according to claim 3 wherein the sensor for sensing introduction of medicament into the holding chamber and the detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber are constituted by a single sensor.

19. Apparatus according to claim 18 wherein the single sensor is disposed in the port of the holding chamber.

20. Apparatus for administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising

a holding chamber for temporarily holding the medicament and gas prior to inhalation;

means for introducing a quantity of the medicament into the holding chamber;

a sensor for sensing the introduction of the medicament into the holding chamber;

detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber; and

calculation means operably connected to the sensor and to the detector means for calculating the amount of medicament received by a patient on the basis of;

the preset quantity of medicament released into the holding chamber;

of the preset volume of the holding chamber;

the time elapsed from the sensing of the introduction of the medicament, of the detected rate of flow of gas inhaled from the holding chamber;

the calculation being made by assessing the concentration of the medicament in the holding chamber on the basis of the detected inhaled volume during reduction of the said concentration within the holding chamber due at least in part to dilution of the medicament within the holding chamber, and by determining the volume of the gas received by the patient during inhalation.

21. Apparatus for administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising

a holding chamber for holding the medicament and gas prior to inhalation;

means for introducing a quantity of the medicament into the holding chamber;

a sensor for sensing introduction of the medicament into the holding chamber;

detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber; and

calculation means operably connected to the sensor and to the detector means for calculating the amount of medicament received by a patient, the calculation means including

a timing means for indicating the time elapsed since the sensor senses the introduction of medicament into the holding chamber;

means for supplying the initial concentration of medicament into the holding chamber immediately after the introduction of medicament therein;

means for determining the concentration of medicament in the holding chamber during inhalation by the patient, the concentration of medicament reducing with the volume of gas inhaled due at least in part to dilution of the medicament within the holding chamber, the determination being made on the basis of the initial concentration supplied by the means for supplying initial concentration, and of the volume of gas inhaled, calculated from the rate of flow of gas detected by the detector since the sensor sensed the introduction of medicament into the holding chamber; and

means for determining the amount of medicament received by the patient by calculating the volume of gas inhaled by the patient from the holding chamber by integrating the rate of flow detected by the detector means, and by multiplying the calculated volume of gas by the concentration of medicament in the holding chamber at that time determined by the means for determining the concentration of medicament.

22. A method for administering a measured dosage of a fluid medicament to a patient in a gas for inhalation using an apparatus comprising:

a holding chamber for holding the medicament and gas prior to inhalation;

means for introducing a quantity of medicament into the holding chamber;

a sensor for sensing the introduction of medicament into the holding chamber;

detector means for detecting the rate of flow of gas inhaled by a patient from the holding chamber; and

calculation means operably connected to the sensor and to the detector means for calculating the amount of medicament received by a patient;

the method comprising;

sensing the introduction of medicament into the holding chamber, the sensing being made by the sensor;

monitoring the time elapsed since the introduction of the medicament is sensed, the monitoring being made by the calculation means;

supplying the value of the initial concentration of medicament in the holding chamber;

determining the concentration of medicament in the holding chamber during inhalation by the patient, the concentration of medicament reducing with time due at least in part to deposition of the medicament within the holding chamber, the determination being made on the basis of the supplied initial concentration and of the time elapsed since the sensor senses the introduction of medicament into the holding chamber; and

determining the amount of medicament received by the patient by calculating the volume of gas inhaled by the patient from the holding chamber by integration of the rate of flow detected by the detector means, and by multiplying the calculated volume of gas by the determined concentration of medicament in the holding chamber at that time.

23. A method of administering a fluid medicament to a patient in a gas for inhalation and for calculating the dosage administered to the patient comprising

sensing the introduction of a quantity of medicament into a holding chamber;

detecting the rate of flow of gas inhaled by a patient from the holding chamber;

monitoring the time elapsed from the sensing of the introduction of the quantity of medicament into the holding chamber;

determining the concentration of medicament in the holding chamber during inhalation by the patient, the concentration of medicament reducing with time due at least in part to deposition of the medicament within the holding chamber, the determination being made on the basis of the predetermined initial concentration of medicament within the holding chamber immediately after the introduction of medicament therein, and on the basis of the monitored time elapsed since the sensing of the introduction of medicament; and

calculating the amount of medicament received by the patient by calculating the volume of gas inhaled by the patient from the holding chamber by integrating the detected rate of flow, and by multiplying the calculated volume of gas inhaled by the determined concentration of medicament in the holding chamber.