Systems And Methods Of Administering A Pharmaceutical Gas to A Patient

• US 20120180790A1
• Filed: 12/20/2011
• Published: 07/19/2012
• Est. Priority Date: 09/21/2005
• Status: Active Grant

• Current Assignee: Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: INO Therapeutics LLC (Mallinckrodt plc)
• Inventors: Montgomery, Frederick J., Bathe, Duncan P.
• Granted Patent: US 8,893,717 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 16/105 Filters A61M16/047, A61M16/22 take precedence; water traps A61M16/08
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 2016/0015 inhalation detectors
• 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 2016/003 with a flowmeter
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/75 with filters

Abstract

Methods and systems for delivering a pharmaceutical gas to a patient. The methods and systems provide a known desired quantity of the pharmaceutical gas to the patient independent of the respiratory pattern of the patient over a plurality of breaths every n^th breath, where n is greater than or equal to 1. The pharmaceutical gases include 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, continue, activate and alarm, etc.

Claims

1. A method of administering a therapy gas to a patient, the therapy gas being at least one gas selected from CO and NO, the method comprising:

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

administering a quantity of therapy gas to the patient during inspiration every n^th breath of the plurality of breaths, wherein n is 1 or greater; and

varying the quantity of therapy gas per n^th breath to ensure that the desired total quantity over the period of time is administered independent of the respiratory pattern of the patient.

2. The method of claim 1, wherein the quantity of therapy gas per n^th breath is in the range of a minimum quantity of therapy gas per breath and a maximum quantity of therapy gas per breath.

3. The method of claim 2, wherein the quantity of therapy gas per n^th breath is a function of one or more of a first respiratory rate, a first tidal volume of the patient and the patient'"'"'s ideal body weight.

4. The method of claim 3, wherein when the quantity of therapy gas per n^th breath to be delivered is greater than the minimum quantity of therapy gas per breath and less than the maximum quantity of therapy gas per breath, the quantity of therapy gas per breath is administered on the n^th breath, or when the quantity of therapy gas per n^th breath is less than the minimum quantity of therapy gas per breath, administration of the quantity of therapy gas per n^th breath is skipped for that n^th breath, or when the quantity of therapy gas per n^th breath is greater than the maximum quantity of therapy gas per breath, one or more of an alarm is triggered or the maximum quantity is delivered on the n^th breath and a difference between the quantity of therapy gas per n^th breath to be delivered and the maximum quantity of therapy gas per breath is carried to one or more subsequent breaths.

5. The method of claim 4, wherein when the quantity of therapy gas per n^th breath is skipped, a new quantity of therapy gas per n^th breath is calculated.

6. The method of claim 4, wherein when the quantity of therapy gas per n^th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n^th breath and the difference between the quantity of therapy gas per n^th breath and the maximum quantity of therapy gas per breath is added to one or more subsequent breaths.

7. The method of claim 1, wherein n is 2 or greater and the therapy gas is delivered during the n^th breath.

8. The method of claim 7, wherein no therapy gas is administered during the breaths that are not n^th breaths.

9. The method of claim 7, wherein the quantity of therapy gas per n^th breath is in the range of a minimum quantity of therapy gas per breath and a maximum quantity of therapy gas per breath.

10. The method of claim 9, wherein the quantity of therapy gas per n^th breath is a function of one or more of a first respiratory rate, a first tidal volume of the patient and the patient'"'"'s ideal body weight.

11. The method of claim 10, wherein when the quantity of therapy gas per n^th breath to be delivered is greater than the minimum quantity of therapy gas per breath and less than the maximum quantity of therapy gas per breath, the quantity of therapy gas per n^th breath is administered on the n^th breath, or when the quantity of therapy gas per n^th breath is less than the minimum quantity of therapy gas per breath, administration of the quantity of therapy gas per n^th breath is skipped for that n^th breath, or when the quantity of therapy gas per n^th breath is greater than the maximum quantity of therapy gas per breath, one or more of an alarm is triggered or the maximum quantity is delivered on the n^th breath and a difference between the quantity of therapy gas per n^th breath to be delivered and the maximum quantity of therapy gas per breath is carried to one or more subsequent breaths.

12. The method of claim 11, wherein when the quantity of therapy gas per n^th breath is skipped, a new quantity of therapy gas per n^th breath is calculated.

13. The method of claim 12, further comprising repeating the administration of the therapy gas on one or more subsequent breaths.

14. The method of claim 11, wherein when the quantity of therapy gas per n^th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n^th breath and the difference between the quantity of therapy gas per n^th breath and the maximum quantity of therapy gas per breath is added to one or more subsequent breaths.

15. The method of claim 14, further comprising repeating the administration of the therapy gas on one or more subsequent breaths.

16. The method of claim 11, wherein when the quantity of therapy gas per n^th breath is greater than the maximum quantity of therapy gas per breath, the maximum quantity of therapy gas per breath is administered on the n^th breath and the difference between the quantity of therapy gas per n^th breath and the maximum quantity of therapy gas per breath is administered over one or more subsequent breaths that are not an n^th breath.

17. The method of claim 1, wherein the therapy gas is delivered to the patient'"'"'s alveoli.

18. The method of claim 1, wherein the therapy gas is delivered to the patient during the first half of the inspiratory cycle.

19. A method of administering a therapy gas to a patient, the therapy gas being at least one of CO and NO, the method comprising:

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

b) calculating a quantity of therapy gas to be administered to the patient every n^th breath, calculating the quantity based on one or more of respiratory rate and quantity already given to the patient;

c) administering the quantity of therapy gas to the patient'"'"'s alveoli during the first half of the inspiratory cycle for every n^th breath of the plurality of breaths, n being greater than 1 averaged over the period of time; and

d) repeating steps b) and c) varying the quantity of therapy gas per n^th breath to ensure that the desired total quantity over the period of time is maintained independent of the respiratory pattern of the patient.

20. The method of claim 19, further comprising comparing the quantity of therapy gas to be delivered to determine if the quantity is in the range of a minimum quantity and a maximum quantity.

21. The method of claim 20, wherein, if the quantity of therapy gas to be delivered is lower than the minimum quantity, then the quantity of therapy gas delivered during the breath is zero and the quantity of therapy gas to be delivered is added to one or more subsequent breaths.

22. The method of claim 20, wherein if the quantity of therapy gas to be delivered is greater than the maximum quantity, then performing one or more of activating an alarm, determining the difference between the quantity of therapy gas to be delivered and the maximum quantity, administering the maximum quantity or adding the difference between the quantity of therapy gas to be delivered and the maximum quantity to one or more subsequent breaths.

23. A system for administering a therapy gas to a patient having a respiratory pattern, the therapy gas being at least one gas selected from CO and NO, the system comprising:

an inlet to connect to a source of the therapy gas;

an outlet to connect to a device that introduces the therapy gas to the patient;

a setting control to determine a desired total quantity of therapy gas to be administered to the patient over a period of time over a plurality of breaths;

and a gas control system to administer the desired total quantity of therapy gas to the patient during inspiration by the patient over the period of time is independent of the respiratory pattern of the patient, wherein the gas control system is configured to

a) calculate a quantity of therapy gas to be administered to the patient every n^th breath, calculating the quantity based on one or more of respiratory rate and quantity already given to the patient,

b) administer the quantity of therapy gas to the patient'"'"'s alveoli during the first half of the inspiratory cycle for every n^th breath of the plurality of breaths, n being greater than 1 averaged over the period of time, and

c) repeat steps a) and b) varying the quantity of therapy gas per breath to ensure that the desired total quantity over the period of time is maintained independent of the respiratory pattern of the patient.