System and method of administering a pharmaceutical gas to a patient

• US 8,720,440 B2
• Filed: 07/15/2013
• Issued: 05/13/2014
• 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, Ducan P.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/942,049
• Publication Number:
  US 20130298909A1
• Time in Patent Office: 302 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 method of delivering a pharmaceutical gas to a patient'"'"'s alveoli, comprising:

delivering the pharmaceutical gas to the alveoli at an initial calculated dose rate,

during delivery of the pharmaceutical gas, monitoring the patient'"'"'s breath for variability in the patient'"'"'s respiratory rate, and, calculating subsequent dose rates to correct for any variability in the respiratory rate, respectively, and

delivering the pharmaceutical gas to the alveoli at the respective subsequent calculated dose rates.

2. The method of claim 1, further comprising at least one of setting or determining one or more of (1) the initial calculated dose rate of the pharmaceutical gas to be delivered to the patient, (2) a desired set quantity of the pharmaceutical gas to be delivered to the patient, (3) an amount of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

3. The method of claim 1, further comprising one or more of terminating delivery of the pharmaceutical gas to the patient;

terminating delivery of the pharmaceutical gas to the patient when at least one of a duration expires or when a desired set quantity is delivered to the alveoli; and

providing an alarm when at least one of a duration expires or when a desired set quantity is delivered to the alveoli.

4. The method of claim 1, wherein the pharmaceutical gas delivered to the patient one or more of comprises nitric oxide and is supplied from a gas source comprising nitric oxide in a carrier gas.

5. The method of claim 1, wherein monitoring the patient'"'"'s breath for variability in the patient'"'"'s respiratory rate comprises monitoring at least one of the patient inspiration and respiratory rate.

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

7. A method of delivering a pharmaceutical gas to a patient over a plurality of breaths, comprising:

delivering an initial dose of a desired set quantity of the pharmaceutical gas to the patient;

monitoring for variability in the patient'"'"'s respiration;

calculating a subsequent dose of the desired set quantity of pharmaceutical gas to correct for any variability in the patient'"'"'s respiration; and

delivering the subsequent dose of the pharmaceutical gas to the patient.

8. The method of claim 7, further comprising at least one of setting or determining one or more of (1) the initial dose of pharmaceutical gas to be delivered to the patient, (2) the desired set quantity of the pharmaceutical gas to be delivered to the patient, (3) an amount of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

9. The method of claim 8, further comprising one or more of terminating delivery of the pharmaceutical gas to the patient;

terminating delivery of the pharmaceutical gas to the patient when at least one of a duration expires or when the desired set quantity is delivered; and

providing an alarm when at least one of a duration expires or when the desired set quantity is delivered.

10. The method of claim 8, wherein the pharmaceutical gas delivered to the patient one or more of comprises nitric oxide and is supplied from a gas source comprising nitric oxide in a carrier gas.

11. The method of claim 8, wherein monitoring for variability in the patient'"'"'s respiration comprises monitoring one or more of the patient inspiration and respiratory rate.

12. The method of claim 11, wherein the subsequent dose of the pharmaceutical gas varies in response to the patient'"'"'s respiratory rate.

13. The method of claim 8, wherein the pharmaceutical gas is delivered to the patient every breath.

14. A method of delivering a pharmaceutical gas to a patient over a plurality of breaths, comprising:

delivering an initial dose of a desired set quantity of the pharmaceutical gas to the patient;

during delivery of the pharmaceutical gas, monitoring for variability in the patient'"'"'s respiration; and

delivering a subsequent dose of the desired set quantity of the pharmaceutical gas to the patient, the subsequent dose correcting for any variability in the patient'"'"'s respiration.

15. The method of claim 14, further comprising at least one of setting or determining one or more of (1) the initial dose of the pharmaceutical gas to be delivered to the patient, (2) the desired set quantity of the pharmaceutical gas to be delivered to the patient, (3) an amount of time to deliver the pharmaceutical gas to the patient, and (4) a number of breaths to deliver the pharmaceutical gas to the patient.

16. The method of claim 14, further comprising one or more of terminating delivery of the pharmaceutical gas to the patient;

terminating delivery of the pharmaceutical gas to the patient when at least one of a duration expires or when the desired set quantity is delivered; and

providing an alarm when at least one of a duration expires or when the desired set quantity is delivered.

17. The method of claim 14, wherein the pharmaceutical gas delivered to the patient one or more of comprises nitric oxide and is supplied from a gas source comprising nitric oxide in a carrier gas.

18. The method of claim 14, wherein monitoring for variability in the patient'"'"'s respiration comprises monitoring one or more of the patient inspiration and respiratory rate.

19. The method of claim 18, wherein the amount of the pharmaceutical gas varies in response to the patient'"'"'s respiratory rate.

20. The method of claim 14, wherein the pharmaceutical gas is delivered to the patient every breath.