Systems and methods for ambulatory generation of nitric oxide

• US 10,328,228 B2
• Filed: 02/27/2018
• Issued: 06/25/2019
• Est. Priority Date: 02/27/2017
• Status: Active Grant

• Current Assignee: Third Pole, Inc.
• Original Assignee: Third Pole, Inc.
• Inventors: Zapol, David G., Hall, Gregory W., Scholz, Wolfgang, Apollonio, Benjamin, Heirtzler, Frank
• Primary Examiner(s): Woodward, Valerie L
• Application Number:
  US15/907,258
• Publication Number:
  US 20180243528A1
• Time in Patent Office: 483 Days
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0093 by adsorption, absorption or filtration
• CPC Class Codes: A61M 16/022 Control means therefor
• 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 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0057 retained by adsorption
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0283 Nitrous oxide (N2O)
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/80 : voice-operated command
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: C01B 21/32 : Apparatus

Abstract

Systems and methods are provided for portable and compact nitric oxide (NO) generation that can be embedded into other therapeutic devices or used alone. In some embodiments, an ambulatory NO generation system can be comprised of a controller and disposable cartridge. The cartridge can contain filters and scavengers for preparing the gas used for NO generation and for scrubbing output gases prior to patient inhalation. The system can utilize an oxygen concentrator to increase nitric oxide production and compliment oxygen generator activity as an independent device. The system can also include a high voltage electrode assembly that is easily assembled and installed. Various nitric oxide delivery methods are provided, including the use of a nasal cannula.

Claims

1. A wearable nitric oxide generation system comprising:

a housing configured to be wearable;

a reactant gas flow path located in the housing, the reactant gas flow path configured to provide release of a pressurized reactant gas at specific flow rates to one or more plasma chambers;

one or more electrodes located in the one or more plasma chambers configured to generate a product gas containing nitric oxide using a flow of the reactant gas through the one or more plasma chambers;

a controller configured to regulate the amount of nitric oxide generated in the reactant gas;

a disposable cartridge including one or more scavenger paths configured to remove NO₂ from the product gas generated by the one or more plasma chambers, and

a connector to deliver the product gas to a patient delivery device;

wherein the controller measures a resonant frequency of a high voltage circuit and controls a frequency and a duty cycle of an AC waveform to maximize excitation of the high voltage circuit; and

wherein the resonant frequency is determined throughout a service life of the system to accommodate changes in environmental conditions, system wear, and/or manufacturing variance.

2. The wearable nitric oxide generation system of claim 1, wherein the disposable cartridge includes an inlet filter, an exhaust scavenger, and/or one or more exhaust filters.

3. The wearable nitric oxide generation system of claim 1, further comprising one or more filters positioned to receive NO-enriched air from the one or more scavenger paths and configured to filter the NO-enriched air.

4. The wearable nitric oxide generation system of claim 1, wherein the patient delivery device is selected from a group consisting of a nasal cannula, a tube located near an ear, and a tube in communication with a trachea.

5. The wearable nitric oxide generation system of claim 1, wherein the system is configured to be used with a device selected from a group consisting of a resuscitation instrument, a ventilator, a defibrillator, a ventricular assist device (VAD), a Continuous Positive Airway Pressure (CPAP) system, a Bilevel Positive Airway Pressure (BiPAP) system, a non-invasive positive pressure ventilator (NIPPV), a heated high-flow nasal cannula application, a nebulizer, an extracorporeal membrane oxygenation (ECMO);

a cardio-pulmonary bypass system, an automated CPR system, an oxygen delivery system, an oxygen concentrator system, an oxygen generation system, and/or an automated external defibrillator (AED).

6. The wearable nitric oxide generation system of claim 1, wherein the system is configured to be used with an oxygen generator or an oxygen concentrator to increase nitric oxide production.

7. The wearable nitric oxide generation system of claim 1, wherein the controller is configured to control the shape of an AC waveform by controlling a frequency and a duty cycle.

8. The wearable nitric oxide generation system of claim 1, wherein the resonant frequency is automatically determined at a power-up of the system.

9. The wearable nitric oxide generation system of claim 1, wherein the resonant frequency is automatically determined at the beginning of each patient treatment.

10. The wearable nitric oxide generation system of claim 1, wherein the resonant frequency is stored in memory between uses so that a resonance search is not required at power-up of the system.

11. The wearable nitric oxide generation system of claim 1, further comprising a user interface configured to allow a user to interact with the system, view information about the system and nitric oxide production, and control parameters related to nitric oxide production.

12. The wearable nitric oxide generation system of claim 1, further comprising a user interface that includes illuminated indicators for alarm status, battery charge status, external power connection, cartridge remaining life, O2 flow detection, GSM connection, and/or NO generation.

13. The wearable nitric oxide generation system of claim 1, further comprising a microphone to receive user voice inputs.

14. The wearable nitric oxide generation system of claim 1, further comprising one or more antennae for GSM, Bluetooth, WiFi and/or other connectivity.

15. The wearable nitric oxide generation system of claim 1, further comprising a reactant gas source in the form of a reservoir in fluid communication with the one or more plasma chambers.

16. The wearable nitric oxide generation system of claim 1, wherein the reactant gas source is a pump.

17. The wearable nitric oxide generation system of claim 1, wherein the system is portable for use outside a hospital.

18. A wearable nitric oxide generation system comprising:

a housing configured to be wearable;

a reactant gas flow path located in the housing, the reactant gas flow path configured to provide release of a pressurized reactant gas at specific flow rates to one or more plasma chambers;

one or more electrodes located in the one or more plasma chambers configured to generate a product gas containing nitric oxide using a flow of the reactant gas through the one or more plasma chambers;

a controller configured to regulate the amount of nitric oxide generated in the reactant gas;

a disposable cartridge including one or more scavenger paths configured to remove NO₂ from the product gas generated by the one or more plasma chambers; and

a connector to deliver the product gas to a patient delivery device;

wherein the controller measures a resonant frequency of a high voltage circuit and controls a frequency and a duty cycle of an AC waveform to maximize excitation of the high voltage circuit; and

wherein the resonant frequency is automatically determined at a power-up of the system.

19. A wearable nitric oxide generation system comprising:

a housing configured to be wearable;

a reactant gas flow path located in the housing, the reactant gas flow path configured to provide release of a pressurized reactant gas at specific flow rates to one or more plasma chambers;

one or more electrodes located in the one or more plasma chambers configured to generate a product gas containing nitric oxide using a flow of the reactant gas through the one or more plasma chambers;

a controller configured to regulate the amount of nitric oxide generated in the reactant gas;

a disposable cartridge including one or more scavenger paths configured to remove NO₂ from the product gas generated by the one or more plasma chambers; and

a connector to deliver the product gas to a patient delivery device;

wherein the controller measures a resonant frequency of a high voltage circuit and controls a frequency and a duty cycle of an AC waveform to maximize excitation of the high voltage circuit; and

wherein the resonant frequency is automatically determined at the beginning of each patient treatment.

20. A wearable nitric oxide generation system comprising:

a housing configured to be wearable;

a reactant gas flow path located in the housing, the reactant gas flow path configured to provide release of a pressurized reactant gas at specific flow rates to one or more plasma chambers;

one or more electrodes located in the one or more plasma chambers configured to generate a product gas containing nitric oxide using a flow of the reactant gas through the one or more plasma chambers;

a controller configured to regulate the amount of nitric oxide generated in the reactant gas;

a disposable cartridge including one or more scavenger paths configured to remove NO₂ from the product gas generated by the one or more plasma chambers; and

a connector to deliver the product gas to a patient delivery device;

wherein the controller measures a resonant frequency of a high voltage circuit and controls a frequency and a duty cycle of an AC waveform to maximize excitation of the high voltage circuit; and

wherein the resonant frequency is stored in memory between uses so that a resonance search is not required at power-up of the system.