Nitric oxide delivery device

• US 8,573,210 B2
• Filed: 11/15/2012
• Issued: 11/05/2013
• 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 R
• Assistant Examiner(s): TSAI, MICHAEL JASPER
• Application Number:
  US13/677,483
• Publication Number:
  US 20130074838A1
• Time in Patent Office: 355 Days
• Field of Search: 128/203.12, 128/203.14, 128/204.18, 12820421-20123, 128/205.24, 251/129.04, 700/282
• 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 nitric oxide delivery device comprising:

a control module to deliver a gas comprising NO to a patient in an amount effective to treat or prevent hypoxic respiratory failure; and

a valve assembly to deliver the gas comprising NO from a gas container containing the gas comprising NO to the control module, the valve assembly comprising;

a valve attachable to the gas container containing the gas comprising NO, 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 comprising NO through the valve to the control module; and

a circuit supported within the valve assembly and disposed between the actuator and a cap, the circuit including;

a valve memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration in the gas container and

a valve processor and a valve transceiver in communication with the valve memory to send and receive wireless optical line-of-sight signals to communicate the gas data to the control module and to verify one or more of the correct gas, the correct gas concentration and that the gas is not expired.

2. The nitric oxide delivery device of claim 1, where in the valve assembly further comprises a data input disposed on the actuator and in communication with said valve memory, to permit a user to enter the gas data into the valve memory.

3. The nitric oxide delivery device of claim 2, wherein the gas data is provided in a bar code disposed on the gas container and is entered into the data input by a user-operated scanning device in communication with the data input.

4. The nitric oxide delivery device of claim 1, wherein the valve comprises a power source;

and the valve transceiver periodically sends the wireless optical line-of-sight signals to the control module, wherein the signals are interrupted by a duration of time at which no signal is sent.

5. The nitric oxide delivery device of claim 4, wherein the duration of time at which no signal is sent comprises about 10 seconds.

6. The nitric oxide delivery device of claim 1, wherein the control module comprises:

a CPU transceiver to receive line-of-sight signals from the valve transceiver;

a central processing unit (CPU) in communication with the CPU transceiver and including a CPU memory; and

a display to enter patient information into the CPU memory,

wherein the valve transceiver communicates the gas data to the CPU transceiver for storage in the CPU memory, and wherein the CPU compares the patient information entered into the CPU memory via the display and the gas data from the valve transceiver.

7. The nitric oxide delivery device of claim 6, wherein the valve comprises a timer including a calendar timer and an event timer, wherein the valve memory stores the date and time of opening and closing of the valve and the duration of time that the valve is open and the valve transceiver communicates the date and time of opening and closing of the valve to the CPU transceiver for storage in the CPU memory.

8. The nitric oxide delivery device of claim 6, wherein the CPU comprises an alarm that is triggered when the patient information entered into the CPU memory and the gas data from the valve transceiver do not match.

9. The nitric oxide delivery device of claim 6, wherein the CPU memory comprises instructions that cause the CPU processor to:

receive gas data from the valve via a wireless optical line-of-sight signal with the valve connected to the gas container containing gas comprising NO;

compare the gas data with user-inputted patient information;

coordinate delivery of therapy to the patient with a medical device via the wireless optical line-of-sight signal between the CPU transceiver and the valve transceiver;

select a therapy for delivery to a patient based on the received patient information; and

control delivery of the selected therapy to the patient.

10. The nitric oxide delivery device of claim 9, wherein the CPU memory further comprises instructions that cause the CPU processor to:

receive a first valve status selected from a first open position and a first closed position from a first valve via a first wireless optical line-of-sight signal with the first valve connected to a first gas container;

receive a second valve status selected from a second open position and a second closed position from a second valve via a second wireless optical line-of-sight signal with the second valve connected to a second gas container;

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.

11. The nitric oxide delivery device of claim 10, wherein the memory further comprises instructions that causes the CPU processor to:

terminate delivery of therapy if the first valve status comprises the first open position and the second valve status comprises the second open position.

12. A method for treating or preventing hypoxic respiratory failure in a patient, the method comprising:

providing the nitric oxide delivery device of claim 6;

establishing communication between the valve transceiver and the CPU transceiver and communicating the gas data from the valve transceiver to the CPU;

comparing the gas data communicated from the valve transceiver with patient information stored within the CPU memory; and

delivering the gas comprising NO to the patient in an amount effective to treat or prevent hypoxic respiratory failure.

13. The method of claim 12, further comprising ceasing delivery of the gas comprising NO to the patient based on the comparison of the gas data and the patient information.

14. The method of claim 12, further comprising emitting an alert based on the comparison of the gas data and the patient information.

15. The method of claim 12, further comprising entering the gas data into the valve memory.

16. The method of claim 12, further comprising entering the patient information into the CPU memory.