Nitric oxide administration device with timed pulse

• US 6,109,260 A
• Filed: 02/18/1998
• Issued: 08/29/2000
• Est. Priority Date: 02/18/1998
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc), Therakos, Inc (Mallinckrodt plc)
• Original Assignee: Datex-Ohmeda Incorporated (GE Healthcare Technologies, Inc.)
• Inventors: Bathe, Duncan P. L.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): WEISS JR, JOSEPH
• Application Number:
  US09/025,382
• Time in Patent Office: 923 Days
• Field of Search: 128/203.12, 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.23, 128/205.24
• US Class Current: 128/203.12
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]

Abstract

A respiratory therapy apparatus is disclosed that delivers a pulsed volume of NO containing therapeutic gas to a patient upon each inhalation of the patient. The NO delivery system includes certain functions to provide protection against the inadvertent formation of NO₂ through the reaction of NO and O₂ within the device itself. Since the formation of NO₂ is a time based reaction, the delivery system includes a timer that monitors the elapsed time the passes between pulses of a NO containing therapy gas to the patient. In the event that time exceeds a predetermined period, thereby raising the possibility that sufficient time has passed to potentially have toxic concentrations of NO₂ formed, the delivery device automatically itself delivers the pulse of NO containing gas to the patient and which clears the conduits, passageways and the like within the device to rid the device of any NO₂ that may have formed. As a further feature, the device also counts the number of successive times that the system activates itself and when that count exceeds a predetermined number, a fault condition is recognized and an appropriate alert is signaled to the user.

Claims

1. A Nitric Oxide delivery system for delivering a therapeutic amount of nitric oxide to a patient, said system comprising:

a conduit adapted to be connected to a source therapy gas containing nitric oxide (NO) under pressure and communicating the NO containing therapy gas to a patient through a patient utilization device,

a control valve in said conduit adapted to open and close to deliver the NO containing therapy gas to a patient in predetermined, timed pulses,

a patient trigger device adapted to detect the inhalation of a patient and to provide a signal indicative of a patient attempting to inhale,

a central processing unit receiving the signal from said patient trigger device, said central processing unit adapted to send a signal to said control valve in response to said signal from said patient trigger device to open said control valve for a predetermined time to provide a pulse of NO containing therapy gas to a patient,

a timer adapted to detect a predetermined elapsed time following the delivery of a pulse of NO containing therapy gas, in which time the administration of a subsequent pulse of NO containing therapeutic gas does not occur, and to provide a signal to said central processing unit when said predetermined elapsed time has passed, and

said central processing unit receiving the signal from said timer and adapted to send a signal to said control valve in response to said signal from said timer to open said control valve for a predetermined time to provide a pulse of NO containing therapy gas to flush said conduit.

2. A nitric oxide delivery system as defined in claim 1 wherein said timer its reset whenever said patient trigger device is activated to open said control valve.

3. A nitric oxide delivery system as defined in claim 1 wherein said system further includes a counter that counts the number of successive times said central processing unit opens said control valve in response to said signal from said timer to provide a pulse of NO containing therapeutic gas to a patient.

4. A nitric oxide delivery system as defined in claim 3 wherein said counter provides an indication to a user when said counter has counted a predetermined number of successive times.

5. A Nitric Oxide delivery system for delivering a therapeutic amount of nitric oxide to a patient, said system comprising:

a conduit adapted to be connected to a source therapy gas containing nitric oxide (NO) under pressure and communicating the NO containing therapy gas to a patient through a patient utilization device,

a signal operated control valve in said conduit adapted to open and close to deliver the NO containing therapy gas to a patient in predetermined, timed pulses,

a patient trigger device adapted to detect the inhalation of a patient and to provide a signal indicative of a patient attempting to inhale,

a central processing unit receiving the signal from said patient trigger device, said central processing unit adapted to send a signal to said signal operated valve in response to said signal from said patient trigger device to open said valve for a predetermined time to provide a pulse of NO containing therapy gas to a patient,

said central processing device including a timer adapted to detect a predetermined elapsed time following the delivery of a pulse of NO containing therapy gas to a patient and in which time the administration of a subsequent pulse of NO containing therapeutic gas does not occur and to provide a signal to said central processing unit when said predetermined elapsed time has passed, and

said central processing unit receiving the signal from said timer and adapted to send a signal to said signal operated valve in response to said signal from said timer to open said valve for a predetermined time to provide a pulse of NO containing therapy gas to a patient to flush said conduit.

6. A nitric oxide delivery system as defined in claim 5 wherein said signal operated valve is a solenoid operated valve.

7. A nitric oxide delivery system as defined in claim 5 wherein said predetermined elapsed time is about 15 seconds.

8. A nitric oxide delivery system as defined in claim 5 wherein said central processing unit includes a counter that counts the number of successive times said central processing unit provides said signal to open said signal operated valve in response to said signal from said timer.

9. A nitric oxide delivery system as defined in claim 8 wherein said counter provides an alert to the user when said counter has counted a predetermined number of said successive times.

10. A nitric oxide delivery system as defined in claim 8 wherein said number of successive times is about 3 to 4.

11. A method of providing an automatic pulse of a NO containing therapy gas to a patient in a NO delivery system having a conduit to deliver a gas containing a nitric oxide from a source of nitric oxide to a patient, said method comprising:

(a) providing a control valve intermediate the source of nitric oxide and the patient;

(b) opening the valve to deliver a pulse of nitric oxide containing therapy gas to a patient for a predetermined dosage of the therapeutic gas,

(c) sensing the inhalation of a patient to control the opening of the control valve,

(d) timing elapsed times between successive sensed inhalations of a patient;

(e) determining that an elapsed time of step (d) exceeds a predetermined period of time; and

(f) opening the control valve to deliver a pulse of nitric oxide containing therapy gas to flush the conduit upon determination of step (e).

12. A method of providing an automatic pulse of a NO containing therapy gas to a patient as defined in claim 11 wherein said timing step (d) further includes resetting the time upon each opening of the valve.

13. A method of providing an automatic pulse of a NO containing therapy gas to a patient as defined in claim 11 wherein step (e) is further defined as determining that an elapsed time of step (d) exceeds a predetermined period of time of about 15 seconds.

14. A method of providing an automatic pulse of a NO containing therapy gas to a patient as defined in claim 11 wherein said method further includes the step of:

(g) counting the number of successive times the control valve is opened by step (f).

15. A method of providing an automatic pulse of a NO containing therapy gas to a patient as defined in claim 14 further including the step of:

(h) alerting a user upon the counting of a predetermined number of successive times in step (g).

16. A method of providing an automatic pulse of a NO containing therapy gas to a patient as defined in claim 15 wherein step (h) is further defined as alerting a user upon the counting of a predetermined number of successive times of about 3 to 4.