Nitric oxide delivery device

• US 8,776,794 B2
• Filed: 10/29/2013
• Issued: 07/15/2014
• Est. Priority Date: 01/06/2011
• 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: Bathe, Duncan P., Klaus, John, Christensen, David
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): TSAI, MICHAEL JASPER
• Application Number:
  US14/065,951
• Publication Number:
  US 20140053836A1
• Time in Patent Office: 259 Days
• Field of Search: 128/203.12, 128/203.14, 128/204.18, 12820421-20423, 128/205.24, 128/898
• US Class Current: 128/205.24
• 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 16/0808 Condensation traps
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/1005 with O2 features or with parameter measurement
• CPC Class Codes: A61M 16/104 specially adapted for anaesthetics A61M16/18 takes precedence
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/102 Measuring a parameter of the content of the delivered gas
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2016/1035 : the anaesthetic agent concentration
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2202/0233 : Carbon monoxide
• CPC Class Codes: A61M 2202/0266 : Nitrogen (N)
• CPC Class Codes: A61M 2202/0275 : Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0283 : Nitrous oxide (N2O)
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/27 : preventing use
• CPC Class Codes: A61M 2205/3327 : Measuring
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/35 : Communication
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/6009 : for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: F17C 2205/013 : Two or more vessels
• CPC Class Codes: F17C 2205/0161 : with wheels
• CPC Class Codes: F17C 2205/0308 : Protective caps
• CPC Class Codes: F17C 2205/05 : Vessel or content identifications, e.g. labels
• CPC Class Codes: F17C 2205/054 : by bar codes
• CPC Class Codes: F17C 2221/01 : Pure fluids
• CPC Class Codes: F17C 2221/011 : Oxygen
• CPC Class Codes: F17C 2250/032 : using computers
• CPC Class Codes: F17C 2270/02 : for medical applications

Abstract

A nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.

Claims

1. A gas delivery device comprising:

a gas source to provide therapy gas comprising nitric oxide;

a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve to allow the gas through the valve to a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure; and

a circuit including;

a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and

a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.

2. The device of claim 1, wherein the valve further comprises a data input in communication with said memory, to permit a user to enter the gas data into the memory.

3. The device of claim 1, wherein the signals comprise wireless optical line-of-sight signals.

4. The device of claim 1, further comprising a power source, wherein the transceiver periodically sends the signals to the control module and the signals are interrupted by a duration of time at which no signal is sent to conserve the power source.

5. The device of claim 4, wherein the duration of time at which no signal is sent is in the range from about 5 seconds to about 20 seconds.

6. The device of claim 1, wherein the memory is disposed between the actuator and a cap.

7. A therapy gas delivery system comprising:

a gas delivery device comprising;

a gas source to provide therapy gas comprising nitric oxide;

a valve attached to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve; and

a circuit comprising;

a first memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration of the gas source; and

a first processor and a first transceiver in communication with the first memory; and

a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure, the control module comprising a second memory, a second transceiver and a second processor, wherein the second transceiver and the second processor are in communication with the second memory,

wherein the first transceiver and the second transceiver send and receive signals to communicate the gas data to the control module and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.

8. The system of claim 7, wherein the control module further comprises a display to enter patient information into the second memory.

9. The system of claim 8, wherein the second processor compares the patient information entered into the second memory via the display and the gas data that the first transceiver communicated to the second transceiver.

10. The system of claim 9, wherein the control module comprises an alarm that is triggered when the patient information entered into the second memory and the gas data from the valve transceiver do not match.

11. The system of claim 7, wherein the second memory comprises instructions that cause the second processor to:

receive gas data from the gas delivery device;

compare the gas data with user-inputted patient information; and

control delivery of the therapy gas to the patient.

12. The system of claim 11, wherein the second processor verifies one or more of the gas identification, the gas concentration and that the gas is not expired prior to delivery of the therapy gas to the patient.

13. The system of claim 7, wherein the second memory comprises instructions that cause the second processor to:

receive a first valve status selected from a first open position and a first closed position from a first valve connected to a first gas source;

receive a second valve status selected from a second open position and a second closed position from a second valve connected to a second gas source;

compare the first valve status and the second valve status; and

emit an alarm if the first valve status comprises the first open position and the second valve status comprises the second open position.

14. The system of claim 7, wherein the signals comprise wireless optical line-of-sight signals.

15. A method for administering a therapy gas to a patient, comprising:

establishing communication between a gas delivery device and a control module for administering therapy gas to a subject via a first transceiver and a second transceiver, wherein the gas delivery device comprises a gas source and the first transceiver is in communication with a first memory that stores gas data comprising one or more of gas identification, gas expiration date and gas concentration of the gas source, wherein the control module comprises the second transceiver and a second memory;

communicating the gas data from the first transceiver to the second transceiver via wired or wireless signals;

comparing the gas data with patient information stored in the second memory to verify the gas data; and

delivering therapy gas comprising nitric oxide to the patient in an amount effective to treat or prevent hypoxic respiratory failure.

16. The method of claim 15, wherein the signals comprise wireless optical line-of-sight signals.

17. The method of claim 15, further comprising preventing or ceasing delivery of the therapy gas to the patient based on the comparison of the gas data and the patient information.

18. The method of claim 15, further comprising emitting an alert based on the comparison of the drug data and the patient information.

19. The method of claim 15, further comprising entering the drug data into the first memory.

20. The method of claim 15, further comprising entering the patient information into the second memory.