System and method of administering a pharmaceutical gas to a patient

• US 8,408,206 B2
• Filed: 06/28/2012
• Issued: 04/02/2013
• 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:
  US13/536,272
• Publication Number:
  US 20120266879A1
• Time in Patent Office: 278 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

Described are methods and systems for delivering pharmaceutical gas to a patient. The methods and systems utilize a high flow valve and a low flow valve in parallel flow paths. The pharmaceutical gas may be provided as a pulse during the first half of the patient'"'"'s inspiratory cycle.

Claims

1. A nitric oxide delivery system comprising:

an inlet to connect to a source of pharmaceutical gas comprising nitric oxide;

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

a low flow valve in fluid communication with the inlet and outlet, wherein the low flow valve delivers the pharmaceutical gas at a first flow rate;

a high flow valve in fluid communication with the inlet and outlet and in parallel to the low flow valve, wherein the high flow valve delivers the pharmaceutical gas at a second flow rate that is higher than the first flow rate; and

a gas control system that delivers a pulse of the pharmaceutical gas through one or more of the low flow valve and the high flow valve wherein the control system delivers the pulse of pharmaceutical gas during the first half of the patient'"'"'s inspiratory cycle.

2. The system of claim 1, wherein the low flow valve provides a flow of pharmaceutical gas of about 1 L/min.

3. The system of claim 1, wherein the high flow valve provides a flow of pharmaceutical gas of about 6 L/min.

4. The system of claim 1, wherein the ratio of the flow rate of the high flow valve to the flow rate of the low flow valve is about 6:

1.

5. The system of claim 1, wherein the device that introduces the pharmaceutical gas to the patient is in fluid communication with a ventilator.

6. The system of claim 1, wherein the device that introduces the pharmaceutical gas to the patient comprises one or more of a nasal cannula, an endotracheal tube and a face mask.

7. The system of claim 1, wherein the source of pharmaceutical gas comprises nitric oxide in a known concentration in a carrier gas.

8. The system of claim 7, wherein the gas 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.

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

10. A method of administering a pharmaceutical gas comprising nitric oxide to a patient, the method comprising:

providing a nitric oxide delivery system having a low flow valve and a high flow valve in parallel flow paths, wherein the high flow valve delivers the pharmaceutical gas at a flow rate higher than a flow rate of the low flow valve;

sensing the beginning of patient inspiration; and

delivering a pulse of pharmaceutical gas comprising nitric oxide to the patient during inspiration through one or more of the low flow valve and the high flow valve.

11. The method of claim 10, wherein the pulse of pharmaceutical gas is delivered during the first half of the patient'"'"'s inspiratory cycle.

12. The method of claim 10, wherein the low flow valve provides a flow of pharmaceutical gas of about 1 L/min.

13. The method of claim 10, wherein the high flow valve provides a flow of pharmaceutical gas of about 6 L/min.

14. The method of claim 10, wherein the ratio of the flow rate of the high flow valve to the flow rate of the low flow valve is about 6:

1.

15. The method of claim 10, wherein the pharmaceutical gas comprises nitric oxide in a known concentration in a carrier gas.

16. The method of claim 15, 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.

17. The method of claim 10, further comprising determining the patient'"'"'s respiratory rate.