Systems and methods of administering a pharmaceutical gas to a patient

• US 10,099,029 B2
• Filed: 11/24/2014
• Issued: 10/16/2018
• Est. Priority Date: 09/21/2005
• Status: Active Grant

• Current Assignee: Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Hospital Products IP Ltd. (Mallinckrodt plc)
• Inventors: Montgomery, Frederick J., Bathe, Duncan P.
• Primary Examiner(s): Douglas, Steven
• Application Number:
  US14/551,186
• Publication Number:
  US 20150075526A1
• Time in Patent Office: 1,422 Days
• 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 pharmaceutical gas to a patient, wherein the pharmaceutical gas comprises at least one of nitric oxide or carbon monoxide, the method comprising:

delivering a first quantity of the pharmaceutical gas from a source of pharmaceutical gas to the patient in a first breath;

monitoring the patient'"'"'s respiratory rate or changes in the patient'"'"'s respiratory rate with a sensor; and

varying the quantity of pharmaceutical gas delivered to the patient in one or more subsequent breaths based on the monitored respiratory rate or changes in the patient'"'"'s respiratory rate, wherein at least one breath is skipped such that pharmaceutical gas is not administered during the at least one breath, and wherein when the at least one breath is skipped, at least a portion of a skipped amount not administered during the at least one breath is added to a next breath following the at least one breath.

2. The method of claim 1, wherein the quantity delivered in the subsequent breath is greater than the first quantity in response to a decrease in the patient'"'"'s respiratory rate.

3. The method of claim 1, wherein the quantity delivered in the subsequent breath is less than the first quantity in response to an increase in the patient'"'"'s respiratory rate.

4. The method of claim 1, wherein varying the quantity of pharmaceutical gas delivered to the patient avoids high unsafe doses or doses too low to be effective.

5. The method of claim 1, wherein when the quantity of pharmaceutical gas to be delivered in a breath is greater than a maximum quantity of pharmaceutical gas per breath, the maximum quantity of pharmaceutical gas per breath is administered and the difference between the quantity of pharmaceutical gas to be delivered in the breath and the maximum quantity of pharmaceutical gas per breath is added to one or more subsequent breaths.

6. The method of claim 1, wherein one or more of the first quantity and the quantity delivered in the subsequent breath is delivered during the first half of inspiration.

7. A gas delivery system comprising:

an inlet to connect to a source of pharmaceutical gas comprising at least one of nitric oxide or carbon monoxide;

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

a breath trigger sensor to measure a patient'"'"'s respiratory rate; and

a gas control system in communication with the breath trigger sensor that delivers a varying quantity of pharmaceutical gas to the patient based on changes in the patient'"'"'s respiratory rate, wherein at least one breath is skipped such that pharmaceutical gas is not administered during the at least one breath, and wherein when the at least one breath is skipped, at least a portion of a skipped amount not administered during the at least one breath is added to a next breath following the at least one breath.

8. The system of claim 7, wherein a quantity delivered in a subsequent breath is greater than a quantity delivered in a previous breath in response to a decrease in the patient'"'"'s respiratory rate.

9. The system of claim 7, wherein a quantity delivered in a subsequent breath is less than a quantity delivered in a previous breath in response to an increase in the patient'"'"'s respiratory rate.

10. The system of claim 7, wherein the gas control system delivers the quantity of pharmaceutical gas during the first half of the patient'"'"'s inspiratory cycle.

11. The system of claim 7, wherein when a quantity of pharmaceutical gas to be delivered in a breath is greater than a maximum quantity of pharmaceutical gas per breath, the maximum quantity of pharmaceutical gas per breath is administered and the difference between the quantity of pharmaceutical gas to be delivered in the breath and the maximum quantity of pharmaceutical gas per breath is added to one or more subsequent breaths.