High concentration no pulse delivery device

• US 6,089,229 A
• Filed: 05/26/1998
• Issued: 07/18/2000
• Est. Priority Date: 05/26/1998
• 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 (General Electric Company)
• Inventors: Montgomery, Frederick J., Bathe, Duncan P. L.
• Primary Examiner(s): Lewis, Aaron J.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/084,724
• Time in Patent Office: 784 Days
• Field of Search: 128/203.12, 128/203.22, 128/204.23, 128/207.18, 128/204.26, 128/205.11, 128/206.11, 128/204.21
• US Class Current: 128/204.21
• 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 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature

Abstract

A respiratory therapy apparatus that delivers a predetermined pulsed dose of a therapeutic gas to a patient upon inhalation of the patient. The system has separate conduits for the supply of the therapeutic gas at a high concentration and for the supply of a diluent gas. The therapeutic gas conduit has a control valve that is accurately controlled to open and close so as to deliver a precise dose of the high concentration therapeutic gas. The diluent gas conduit has means to ensure there is sufficient flow of diluent gas to ensure the said high concentration therapy gas is diluted to a safe concentration. A third conduit receives the gases from both the first and second conduits so that the gases are mixed together and administered to the patient. By this system, the therapeutic gas supply can be of a high, otherwise harmful, concentration and the therapeutic gas is diluted prior to introduction to the patient. The therapeutic gas may be nitric oxide and the diluent gas may be nitrogen or an oxygen containing gas.

Claims

1. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient at a safe concentration, said apparatus comprising:

means connecting said respiratory therapy apparatus to a source of a high concentration therapeutic gas,

means connecting said respiratory therapy apparatus to a source of a diluent gas,

means to establish a predetermined desired pulse dose of therapeutic gas,

sensing means for sensing the initiation of an inhalation of a patient,

delivery means having a first state and a second state, said delivery means delivering a pulse of high concentration therapeutic gas when said delivery means is in said second state, said delivery means being responsive to said sensing means for sensing the initiation of an inhalation of a patient and controlling the amount of time said delivery means is in the second state to deliver a pulse of said high concentration therapeutic gas during the inhalation of the patient for mixing with said diluent gas;

flow measurement means for measuring the flow of said diluent gas to a patient, and

means responsive to said flow measurement means for providing a sufficient flow of said diluent gas to a patient to ensure said high concentration of therapeutic gas is diluted to a safe concentration when mixed with said diluent gas.

2. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 wherein said high concentration therapeutic gas is nitric oxide.

3. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 wherein said diluent gas is nitrogen.

4. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 wherein said diluent gas is an oxygen containing gas.

5. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 wherein said means for providing a sufficient flow of said diluent gas comprises a delivety means to deliver a flow of diluent gas at a sufficient flow rate to ensure a safe concentration of therapeutic gas.

6. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 5 wherein said high concentration therapeutic gas is nitric oxide.

7. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 6 wherein said diluent gas is oxygen.

8. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 including an alarm activated when said diluent gas flow is insufficient to ensure said high concentration therapeutic gas is diluted to a safe concentration of therapeutic gas.

9. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 including means to inactivate the said therapeutic gas delivery means when said diluent gas flow is insufficient to ensure said high concentration therapeutic gas is diluted to a safe concentration of therapeutic gas.

10. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 1 wherein said means for providing a sufficient flow of diluent gas to a patient is further defined as providing a pulsatile flow of diluent gas.

11. A respiratory therapy apparatus for delivering a therapeutic gas to a patient at a safe concentration, said apparatus comprising;

a first conduit adapted to be connected to a source of high concentration therapeutic gas under pressure,

a second conduit adapted to be connected to a source of a diluent gas,

a nasal cannula adapted to be connected to said first and said second conduits for receiving gas from both of said conduits and having a mixing chamber for mixing the gas from said first conduit and the gas from said second conduit,

said cannula having a prong means for immediately delivering the mixed gas from said mixing chamber into a patient,

delivery means to deliver a high concentration of therapeutic gas during the inhalation of the patient; and

delivery means to deliver a sufficient flow of said diluent gas to ensure said high concentration therapeutic gas is diluted to a safe concentration in mixed gas.

12. A respiratory therapy apparatus for delivering a therapeutic gas to a patient as defined in claim 11 wherein said diluent gas is an oxygen containing gas.

13. A respiratory apparatus for delivering a therapeutic gas to a patient as defined in claim 11 wherein said therapeutic gas includes nitric oxide.

14. A respiratory therapy apparatus for delivering a therapeutic gas to a patient as defined in claim 11 wherein said prong means comprises a pair of nasal prongs that each contain a mixing chamber and which introduce the mixed gas directly into the nostrils of a patient.

15. A respiratory therapy apparatus for delivering a therapeutic gas to a patient as defined in claim 11 wherein said delivery means are control valves having both open and closed positions for delivering pulses of therapeutic gas and diluent gas and wherein the position of said control valves is controlled by a processor.

16. A respiratory therapy apparatus for delivering a therapeutic gas to a patient as defined in claim 15 further comprising a means to sense when a patient is attempting to inhale to provide a signal to said processor and wherein said processor signals said control valves to said open positions based upon said signal indicating inhalation by a patient.

17. A respiratory therapy apparatus for delivering a pulse dose of nitric oxide to a patient at a safe concentration using a diluent gas, said apparatus comprising:

a first conduit adapted to be connected to a source of high concentration nitric oxide gas;

a second conduit adapted to be connected to a source of diluent gas;

first delivery means to deliver a pulse of high concentration nitric oxide gas along said first conduit during inhalation by a patient;

second delivery means to deliver a sufficient flow of the diluent gas along said second conduit to ensure the high concentration nitric oxide gas pulse is diluted to a safe concentration;

means coupled to said first and second conduits for forming a point of confluence for said high concentration nitric oxide gas and said diluent gas from said conduits, the confluence of such gases mixing and diluting said high concentration nitric oxide gas in said diluent gas to provide a safe concentration of nitric oxide and form the pulse dose of nitric oxide; and

third conduit means extending from said point of confluence to a point of administration for a patient for flowing mixed gases to a patient, the location of the point of confluence with respect to the point of administration and such a length of the third conduit means being such as to minimize the time during which the mixture of gases exists prior to administration to a patient.

18. A respiratory therapy apparatus according to claim 17 further defined as delivering a pulse dose of nitric oxide to a patient at a safe concentration using an oxygen containing diluent gas while minimizing the formation of a nitrogen dioxide reaction product, and wherein said second conduit is adapted to be connected to a source of diluent gas containing oxygen.

19. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient at a safe concentration, said apparatus comprising:

first connecting means connecting said respiratory therapy apparatus to a source of high concentration therapeutic gas;

second connecting means connecting said respiratory therapy apparatus to a source of diluent gas for supplying diluent gas to a patient;

means for establishing a desired quantity of therapeutic gas as the pulse dose;

means for sensing the amount of diluent gas supplied to a patient to ensure that the supply of diluent gas is sufficient to dilute said high concentration therapeutic gas to a safe concentration;

delivery means coupled to said first connecting means, said delivery means having a first state and a second state, said delivery means delivering a quantity of gas as a pulse of high concentration therapeutic gas when in said second state;

a sensor for sensing the initiation of inhalation by a patient;

control means for controlling the amount of time said delivery means is in the second state and the quantity of gas delivered by said delivery means as a pulse when inhalation is sensed by said sensor; and

measurement means for measuring the quantity of gas delivered by said delivery means, said measurement means being coupled to said control means to alter the quantity of gas delivered by said delivery means responsive to the measured quantity of gas so that the pulse dose delivered to a patient contains the desired quantity of therapeutic gas.

20. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 19 wherein said high concentration therapeutic gas is nitric oxide.

21. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient at a safe concentration, said apparatus comprising:

first connecting means connecting said respiratory therapy apparatus to a source of high concentration therapeutic gas;

second connecting means connecting said respiratory therapy apparatus to a source of diluent gas for supplying diluent gas to a patient;

means for establishing a desired quantity of therapeutic gas as the pulse dose;

diluent gas flow measurement means for measuring the amount of diluent gas supplied to a patient to ensure that the supply of diluent gas is sufficient to dilute said high concentration therapeutic gas to a safe concentration;

delivery means coupled to said first connecting means, said delivery means having a first state and a second state, said delivery means delivering a quantity of gas as a pulse of high concentration therapeutic gas when in the second state; and

control means coupled to said delivery means for controlling the amount of time said delivery means is in said second state and the quantity of gas delivered by said delivery means as the pulse, said control means being coupled to said diluent gas flow measuring means for operating said delivery means when a sufficient supply of diluent gas is present.

22. A respiratory therapy apparatus for delivering a pulse dose of a therapeutic gas to a patient as defined in claim 21 wherein said high concentration therapeutic gas is nitric oxide.

23. A respiratory therapy apparatus for delivering a pulse dose of therapeutic gas to a patient as defined in claim 21 further including means in said second connecting means for supplying said diluent gas in pulses of diluent gas.