System and method of administering a pharmaceutical gas to a patient

• US 8,397,721 B2
• Filed: 10/28/2011
• Issued: 03/19/2013
• 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.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/284,433
• Publication Number:
  US 20120042875A1
• Time in Patent Office: 508 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, 128/204.21
• 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

Methods and systems for delivering a total quantity of pharmaceutical gas to a patient. The methods and systems provide one of a low amount and high amount of pharmaceutical gas to a patient. The selection of the high amount or low amount may be determined by comparing the amount per unit of time of pharmaceutical gas delivered to the patient over the past number of breaths to the required quantity of pharmaceutical gas per unit of time. Upon completion of delivering the total quantity of pharmaceutical gas to the patient, the system can terminate, continue, activate and alarm, etc.

Claims

1. A system for administering to a patient a desired total quantity of pharmaceutical gas including at least one gas selected from CO and NO, the system comprising:

an inlet to connect to a source of pharmaceutical gas;

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

a setting control to determine a required quantity of pharmaceutical gas per unit of time to be delivered to the patient over a plurality of breaths; and

a gas control system to select one of a high amount and a low amount of pharmaceutical gas, the selection of the high amount or low amount being determined by comparing the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths to the required quantity of pharmaceutical gas per unit of time, the system configured to deliver the selected high amount or low amount of pharmaceutical gas to the patient.

2. The system of claim 1, wherein the gas control system determines if the amount of pharmaceutical gas per unit of time is greater than the required quantity of pharmaceutical gas per unit of time then the low amount of pharmaceutical gas is selected and delivered to the patient on at least one subsequent breath and if the amount of pharmaceutical gas per unit of time is lower than the required quantity of pharmaceutical gas per unit of time then the high amount of pharmaceutical gas is selected and delivered to the patient on at least one subsequent breath.

3. The system of claim 2, wherein the required quantity of pharmaceutical gas per unit of time to be delivered to the patient is greater than the low amount and less than the high amount.

4. The system of claim 3, wherein comparing the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths to the required quantity of pharmaceutical gas per unit of time to be delivered is performed after every breath.

5. The system of claim 3, wherein if the low amount is selected, the low amount is administered to the patient during subsequent breaths until the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths is less than the required quantity of pharmaceutical gas per unit of time to be delivered and then switching to the high amount for at least one subsequent breath.

6. The system of claim 3, wherein if the high amount is selected, the high amount is administered to the patient during subsequent breaths until the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths is greater than the required quantity of pharmaceutical gas per unit of time to be delivered and then switching to the low amount for at least one subsequent breath.

7. The system of claim 3, wherein the past number of breaths is all of the breaths beginning at onset of treatment.

8. The system of claim 2, wherein the gas control system selects one of the high amount and low amount after every breath.

9. The system of claim 1, wherein the system includes a breath trigger sensor to measure a current monitored respiratory breath rate.

10. The system of claim 1, further comprising a second inlet to connect to a second gas source, the gas source being one of the high amount and low amount and the second gas source being the other of the high amount and low amount.

11. The system of claim 1, further comprising an alarm.

12. The system of claim 11, wherein the system activates the alarm when the desired total quantity of pharmaceutical gas has been delivered to the patient.

13. A method of delivering to a patient a desired total quantity of a pharmaceutical gas including at least one of CO and NO, the method comprising:

determining a required quantity of pharmaceutical gas per unit of time to be delivered to the patient;

administering an amount of the pharmaceutical gas to the patient during inspiration over at least one breath;

determining the amount of pharmaceutical gas per unit of time delivered to the patient over a past number of breaths;

selecting one of a high amount of pharmaceutical gas and a low amount of pharmaceutical gas to be delivered to the patient on a subsequent breath by comparing the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths to the required quantity of pharmaceutical gas per unit of time to be delivered to the patient, and selecting either the high amount of pharmaceutical gas or the low amount of pharmaceutical gas to be delivered on a subsequent breath; and

delivering either the high amount or the low amount of pharmaceutical gas to the patient on at least one subsequent breath.

14. The method of claim 13, wherein if the amount of pharmaceutical gas per unit of time is greater than the required quantity of pharmaceutical gas per unit of time then the low amount of pharmaceutical gas is selected and if the amount of pharmaceutical gas per unit of time is lower than the required quantity of pharmaceutical gas per unit of time then the high amount of pharmaceutical gas is selected.

15. The method of claim 14, wherein the required quantity of pharmaceutical gas per unit of time to be delivered to the patient is greater than the low amount and less than the high amount.

16. The method of claim 15, wherein comparing the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths to the required quantity of pharmaceutical gas per unit of time to be delivered is performed after every breath.

17. The method of claim 16, wherein if the low amount is selected, the low amount is administered to the patient during subsequent breaths until the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths is less than the required quantity of pharmaceutical gas per unit of time to be delivered and then switching to the high amount for at least one subsequent breath.

18. The method of claim 16, wherein if the high amount is selected, the high amount is administered to the patient during subsequent breaths until the amount of pharmaceutical gas per unit of time delivered to the patient over the past number of breaths is greater than the required quantity of pharmaceutical gas per unit of time to be delivered and then switching to the low amount for at least one subsequent breath.

19. The method of claim 16, wherein the past number of breaths is all of the breaths beginning at onset of treatment.

20. The method of claim 13, wherein the pharmaceutical gas is delivered to the patient'"'"'s alveoli during a first half on an inspiratory cycle.