System and method of administering a pharmaceutical gas to a patient

• US 8,616,204 B2
• Filed: 07/15/2013
• Issued: 12/31/2013
• 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.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/942,136
• Publication Number:
  US 20130306068A1
• Time in Patent Office: 169 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

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 pharmaceutical gas delivery system, comprising:

an inlet to connect to at least one gas source;

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

a first flow valve and a first flow orifice in fluid communication with the inlet and the outlet, wherein the first flow valve and the first flow orifice deliver at a first fixed flow rate;

a second flow valve and a second flow orifice in fluid communication with the inlet and the outlet, wherein the second flow valve and the second flow orifice deliver at a second fixed flow rate that is higher than the first fixed flow rate; and

a delivery control system that delivers the pharmaceutical gas over a plurality of breaths by opening one or more of the first flow valve and the second flow valve, wherein the delivery control system delivers the pharmaceutical gas during at least part of the first half of the patient'"'"'s inspiratory cycle.

2. The system of claim 1, wherein one or more of the first fixed flow rate is about 1 L/min and the second fixed flow rate is about 6 L/min.

3. The system of claim 1, wherein the device that introduces the pharmaceutical gas to the patient is one or more of (1) in fluid communication with a ventilator and (2) comprising one or more of a nasal cannula, an endotracheal tube, and a face mask.

4. The system of claim 1, wherein one or more of (1) the pharmaceutical gas that is delivered to the patient comprises nitric oxide and (2) the at least one gas source comprises nitric oxide in a known concentration in a carrier gas.

5. The system of claim 4, wherein the delivery control system controls the volume of pharmaceutical gas delivered during the patient'"'"'s breath based upon the concentration of the nitric oxide in the carrier gas.

6. The system of claim 1, further comprising a patient trigger sensor that senses the beginning of a patient'"'"'s inspiratory cycle.

7. The system of claim 1, wherein the first flow valve and the second flow valve are arranged in parallel.

8. The system of claim 1, wherein the first flow valve and the second flow valve are not open at the same time.

9. The system of claim 1, wherein the pharmaceutical gas delivered opening the first flow valve and the pharmaceutical gas delivered opening the second flow valve are delivered to the patient in different breaths.

10. The system of claim 1, wherein the pharmaceutical gas is delivered to the patient every breath.

11. The system of claim 1, wherein one or more of the first flow valve and the second flow valve open providing at least one of a range of doses, a desired flow rate, a desired volume, and a desired dose.

12. The system of claim 1, wherein the delivery control system at least one of determines or allows setting of one or more of (1) a desired quantity of the pharmaceutical gas to be delivered to the patient over the plurality of breaths, (2) an amount of the pharmaceutical gas per breath to be delivered to the patient, (3) a duration of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

13. The system of claim 1, wherein the pharmaceutical gas is delivered for one or more of (1) a duration of time and (2) a number of breaths.

14. The system of claim 1, wherein an amount of the pharmaceutical gas delivered in at least one breath varies from an amount of the pharmaceutical gas delivered in at least one other breath in the plurality of breaths.

15. The system of claim 14, wherein the amount of the pharmaceutical gas varies in response to the patient'"'"'s respiratory rate.

16. A method of administering a pharmaceutical gas to a patient, the method comprising:

providing a gas delivery system having a first flow valve and a first flow orifice and a second flow valve and a second flow orifice, wherein opening the first flow valve delivers the pharmaceutical gas at a first fixed flow rate and opening the second flow valve delivers the pharmaceutical gas at a second fixed flow rate higher than the first flow rate;

delivering the pharmaceutical gas over a plurality of breaths to the patient during inspiration by opening one or more of the first flow valve and the second flow valve, wherein the pharmaceutical gas is delivered during at least part of the first half of the patient'"'"'s inspiratory cycle.

17. The method of claim 16, wherein one or more of the first fixed flow rate is about 1 L/min and the second fixed flow rate is about 6 L/min.

18. The method of claim 16, wherein the device that introduces the pharmaceutical gas to the patient is one or more of (1) in fluid communication with a ventilator and (2) comprising one or more of a nasal cannula, an endotracheal tube, and a face mask.

19. The method of claim 16, wherein one or more of (1) the pharmaceutical gas that is delivered to the patient comprises nitric oxide and (2) the at least one gas source comprises nitric oxide in a known concentration in a carrier gas.

20. The method of claim 19, wherein the volume of pharmaceutical gas delivered during the patient'"'"'s breath is based upon the concentration of the nitric oxide in the carrier gas.

21. The method of claim 16, wherein the first flow valve and the second flow valve are in fluid communication with a gas source comprising nitric oxide in a carrier gas.

22. The method of claim 16, wherein the first flow valve and the second flow valve are arranged in parallel.

23. The method of claim 16, wherein the first flow valve and the second flow valve are not open at the same time.

24. The method of claim 16, wherein the pharmaceutical gas delivered opening the first flow valve and the pharmaceutical gas delivered opening the second flow valve are delivered to the patient in different breaths.

25. The method of claim 16, wherein the pharmaceutical gas is delivered to the patient every breath.

26. The method of claim 16, wherein one or more of the first flow valve and the second flow valve open providing at least one of a range of doses, a desired flow rate, a desired volume, and a desired dose.

27. The method of claim 16, further comprising at least one of setting or determining one or more of (1) a desired quantity of the pharmaceutical gas to be delivered to the patient over the plurality of breaths, (2) an amount of the pharmaceutical gas per breath to be delivered to the patient, (3) a duration of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

28. The method of claim 16, wherein the pharmaceutical gas is delivered for one or more of (1) a duration of time and (2) a number of breaths.

29. The method of claim 16, wherein an amount of the pharmaceutical gas delivered in at least one breath varies from an amount of the pharmaceutical gas delivered in at least one other breath in the plurality of breaths.

30. The method of claim 29, wherein the amount of the pharmaceutical gas varies in response to the patient'"'"'s respiratory rate.