System and method of administering a pharmaceutical gas to a patient

• US 7,523,752 B2
• Filed: 09/21/2005
• Issued: 04/28/2009
• Est. Priority Date: 09/21/2005
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc), Therakos, Inc (Mallinckrodt plc)
• Original Assignee: INO Therapeutics LLC (Mallinckrodt plc)
• Inventors: Montgomery, Frederick J., Bathe, Duncan P. L.
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US11/231,554
• Publication Number:
  US 20070062527A1
• Time in Patent Office: 1,315 Days
• Field of Search: 128/202.22, 128/203.12, 128/203.14, 128/204.18, 128/204.23, 128/205.23, 128/205.24, 128/205.25, 128/204.21
• US Class Current: 128/204.21
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• 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 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/0233 Carbon monoxide
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A method and system for delivering a pharmaceutical gas to a patient. The method and system provide a known desired quantity of the pharmaceutical gas to the patient independent of the respiratory pattern of the patient. The preferred pharmaceutical gases are CO and NO, both of which are provided as a concentration in a carrier gas. The gas control system determines the delivery of the pharmaceutical gas to the patient to result in the known desired quantity (e.g. in molecules, milligrams or other quantified units) of the pharmaceutical gas being delivered. Upon completion of that known desired quantity of pharmaceutical gas over a plurality of breaths, the system can either terminate any further delivery of the pharmaceutical gas or can activate an alarm to alert the user that the known quantity has been delivered. The system also has alarm functions to alert the user of possible malfunctions of the system.

Claims

1. A method of administering a therapy gas wherein the therapy gas is at least one gas selected from CO and NO gas to a patient during an inspiratory cycle of the patient comprising the steps of:

determining the desired total quantity of therapy gas to be administered to the patient over a plurality of breaths;

administering the therapy gas to the patient'"'"'s alveoli during the first half of the inspiratory cycle over the plurality of breaths so that the desired total quantity of therapy gas delivered is independent of the respiratory pattern of the patient.

2. The method of claim 1 wherein the therapy gas is administered to the patient in a carrier gas.

3. The method of claim 1 wherein the step of administering the therapy gas to the patient includes the step of measuring the respiratory rate of the patient.

4. The method of claim 1 wherein the step of administering the desired quantity of therapy gas includes the step of determining the volume of therapy gas to be delivered per breath and then delivering that volume over a plurality of breaths until the desired quantity of therapy gas has been delivered.

5. The method of claim 1 wherein the step of administering the desired quantity of therapy gas comprises measuring the gas flow to the patient during a breath and terminating the administration of the therapy gas based upon the measured flow of gas to the patient when the desired amount of therapy gas has been delivered.

6. The method of claim 2 where the step of administering the desired quantity of therapy gas is based upon the concentration of the therapy gas in the carrier gas being administered and includes the steps of calculating the time required at the determined concentration to administer the desired quantity of the therapy gas and terminating the administration of the therapy gas when the calculated time has elapsed.

7. The method of claim 1 wherein the step of determining the desired quantity of therapy gas to be administrated to the patient comprises determining the desired quantity in units of mass or units of mass per unit of time.

8. The method of claim 1 wherein the step of determining the desired quantity of therapy gas to be administered to the patient comprises determining the desired quantity in units of moles or moles per unit of time.

9. The method of claim 1 wherein the step of determining the desired quantity of therapy gas to be administered to the patient comprises determining the desired quantity in units of mass per ideal body weight and the patient'"'"'s ideal body weight or in units of mass per unit of time per ideal body weight and the patient'"'"'s ideal body weight.

10. A system for administering a therapy gas wherein the therapy gas is at least one gas selected from CO and NO gas to a patient during the patient'"'"'s inspiratory cycle, the system comprising:

an inlet means for connecting to a source of therapy gas,

an outlet means for connecting to a device for introducing a gas into the lungs of a the patient,

means for determining the desired quantity of therapy gas to be delivered to the patient over a plurality of breaths, and

a gas control system for delivering the desired quantity of the therapy gas to the patient'"'"'s alveoli during the first half of the inspiratory cycle over the plurality of breaths independent of the patient'"'"'s respiratory pattern.

11. The system of claim 10 wherein the mean for determining the desired quantity of therapy gas comprises an inlet setting control.

12. The system of claim 10 wherein the source of therapy gas comprises CO or NO gas at a known concentration in a carrier gas.

13. The system of claim 12 wherein the gas control system includes a central processing unit (CPU) and wherein the CPU controls the amount of therapy gas delivered during the patient'"'"'s breath based upon the concentration of the therapy gas in the carrier gas.

14. The system of claim 13 wherein the CPU delivers the therapy gas and carrier gas over a plurality of breaths until the desired quantity of therapy gas has been delivered based upon the concentration of therapy gas in the carrier gas.

15. The system of claim 10 wherein the gas control system includes a sensor means that determines the volume of gas being delivered per breath of a the patient.

16. The system of claim 10 wherein the gas control system includes a flow sensor that determines the gas flow to the patient.

17. The system of claim 10 wherein the gas control system includes a patient trigger sensor that senses the beginning and end of the inspiratory cycle of the patient.

18. The system of claim 10 wherein the gas control system comprises at least one gas flow valve that is operable by the CPU to provide the therapy gas at a known flow for a period of time.

20. The system of claim 18 wherein the gas control system further includes an orifice downstream of at least one gas control valve to limit the flow of gas therethrough.

21. The system of claim 10 wherein the means for determining the desired quantity of therapy gas is a setting control in units of mass per unit of time.

22. The system of claim 10 wherein the means for determining the desired quantity of therapy gas is a setting control in units of mass.

23. The system of claim 10 wherein the means for determining the desired quantity of therapy gas is a setting control-in units of mass per unit of patient'"'"'s ideal body weight per unit of time and a setting control for inputting the patient ideal body weight.

24. The system of claim 10 wherein the means for determining the desired quantity of therapy gas is a setting control in units of mass per unit of ideal patient body weight and a setting control for inputting the patient ideal body weight.

25. The system of claim 10 wherein the means for determining the desired quantity of therapy gas is a setting control in units of mass per unit of time and a setting control for inputting a time duration for the administration of the therapy gas to the patient.

26. The system of claim 10 wherein the gas control system includes a patient trigger that senses the beginning of an inspiratory cycle of a spontaneously breathing or ventilated patient.

27. The system of claim 26 wherein the gas control system includes a central processing unit (CPU) and wherein the CPU calculates the quantity of therapy gas to be delivered per breath based on the desired quantity of gas, the concentration of the therapy gas in the carrier gas, a time duration for the administration of the therapy gas to the patient and the respiratory rate of the patient as determined by the patient trigger sensor.

28. The system of claim 26 wherein the gas control system includes a central processing unit (CPU) and wherein the CPU calculates the quantity of therapy gas to be delivered per breath based on the desired quantity of gas, the concentration of the therapy gas in the carrier gas and the respiratory rate of the patient.

29. The system of claim 26 wherein the gas control system delivers the quantity of therapy gas to be delivered per breath in the first half of the inspiratory cycle when the patient trigger sensor indicates the beginning of the inspiratory cycle.

19. The system of claim i8 wherein the gas control system comprises a plurality of gas flow control valves in parallel having different ranges of flow allowed therethrough.

30. A system for administering a therapy gas wherein the therapy gas is at least one gas selected from CO and NO gas to a patient during an inspiratory cycle of the patient, the system comprising:

an inlet means for connecting to a source of therapy gas,

an outlet means for connecting to a device for introducing gas into the lungs of the patient,

means for determining the desired quantity of therapy gas to be delivered to the patient over a plurality of breaths,

a gas control system for delivering the therapy gas into the patient during the first half of the inspiratory cycle over a plurality of breaths, and

an alarm device, said gas control system activating said alarm when said desired quantity of the therapy gas has been delivered to the patient.