Device for the treatment of, treatment of complications arising from, and/or prevention of respiratory disorders caused by bacterial, viral, protozoal, fungal and/or microbial infections, preferably for the treatment of complications arising from cystic fibrosis

Patent metadata

Field	Value
Publication number	US-10549062-B2
Application number	US-201515305790-A
Country	US
Kind code	B2
Filing date	Apr 23, 2015
Priority date	Apr 23, 2014
Publication date	Feb 4, 2020
Grant date	Feb 4, 2020

Abstract

The present invention pertains to a device (1) for the treatment of, treatment of complications arising from, and/or preventing respiratory disorders caused by bacterial, viral, protozoal, fungal and/or microbial infections, preferably for the treatment of complications arising from cystic fibrosis (CF), including a positive airway pressure device (2) for providing a breathing gas under a positive pressure to a patient interface (20), a source of nitric oxide (3) for providing gaseous nitric oxide, a gas injector (4) for injecting nitric oxide provided by the source of nitric oxide (3) into the breathing gas provided by the positive airway pressure device (2) under pressure, a flow rate sensor (5) for sensing the flow rate of the breathing gas provided to the patient interface (20) under positive airway pressure, and a controller (6) programmed for controlling the gas injector (4) for injecting the nitric oxide into the breathing gas provided by the positive airway pressure device (2) when a flow rate detected by the flow rate sensor (5) exceeds a predetermined threshold flow rate.

First claim

The invention claimed is:

1. A method for the treatment of respiratory disorders, the treatment of complications arising from respiratory disorders, or the treatment of secondary respiratory disorders caused by bacterial, viral, protozoal, fungal and/or microbial infections in a mammal; said method comprising:
providing a device for the treatment of respiratory disorders, the treatment of complications arising from respiratory disorders, or the treatment of secondary respiratory disorders, said device comprising:
a positive airway pressure device for providing a breathing gas under a positive pressure to a patient interface;
a source of nitric oxide for providing gaseous nitric oxide;
a gas injector for injecting nitric oxide provided by the source of nitric oxide into the breathing gas provided by the positive airway pressure device under pressure;
a flow rate sensor for sensing the flow rate of the breathing gas provided to the patient interface under positive airway pressure; and
a controller programmed for controlling the gas injector for injecting the nitric oxide into the breathing gas provided by the positive airway pressure device when a flow rate detected by the flow rate sensor exceeds a predetermined threshold flow rate wherein the controller is programmed to control the gas injector to inject the nitric oxide to achieve a concentration of nitric oxide in the breathing gas of between 40 ppm and 1000 ppm, and wherein the controller is programmed to control the positive airway pressure device and the gas injector to inject the nitric oxide into the breathing gas during an interval having a duration of between 1 minute to 60 minutes, with said interval provided at a frequency greater than or equal to every second day and lesser than or equal to 5 intervals a day; and

producing an inhalable medicament comprising gaseous nitric oxide with the device for the treatment of complications arising from, and/or preventing respiratory disorders; and
providing the inhalable medicament to an airway of the mammal under positive airway pressure.

2. The method of claim 1 , wherein the controller is programmed to control the gas injector to inject the nitric oxide such that a concentration of the nitric oxide is present in the inhalable medicament with a concentration of between 40 ppm and 1000 ppm.

3. The method of claim 1 , wherein said respiratory disorders, said complications arising from respiratory disorders, or said secondary respiratory disorders caused by bacterial, viral, protozoal, fungal and/or microbial infections are selected from the group consisting of: a ventilator associated pneumonia (VAP), a toxoplasmosis, a heparin-protamine reaction, a traumatic injury, a traumatic injury to the respiratory tract, acidosis or sepsis, acute mountain sickness, acute pulmonary edema, acute pulmonary hypertension, acute pulmonary thromboembolism, adult respiratory distress syndrome, an acute pulmonary vasoconstriction, aspiration or inhalation injury or poisoning, asthma or status asthmaticus, bronchopulmonary dysplasia, hypoxia or chronic hypoxia, chronic pulmonary hypertension, chronic pulmonary thromboembolism, cystic fibrosis (CF), fat embolism of the lung, haline membrane disease, idiopathic or primary pulmonary hypertension, inflammation of the lung, perinatal aspiration syndrome, persistent pulmonary hypertension of a newborn, post cardiac surgery, a bacterial-, viral- and/or fungal bronchiolitis, a bacterial-, viral- and/or fungal pharyngitis and/or laryngotracheitis, a bacterial-, viral- and/or fungal pneumonia, a bacterial-, viral- and/or fungal sinusitis, a bacterial-, viral- and/or fungal upper and/or lower respiratory tract infection, a bacterial-, viral- and/or fungal-exacerbated asthma, a respiratory syncytial viral infection, bronchiectasis, bronchitis, chronic obstructive lung disease (COPD), cystic fibrosis (CF), emphysema, otitis, otitis media, primary ciliary dyskinesia (PCD), and pulmonary aspergillosis (ABPA) and cryptococcosis.

4. The method of claim 1 , further comprising programming the controller to control the gas injector to inject nitric oxide in the concentration of between 80 ppm and 220 ppm into the breathing gas of a positive airway pressure device.

5. The method according to claim 4 , characterized in that the nitric oxide is injected in at least one of a single pulse, multiple subsequent pulses of equal or varying width, or as a constant flow with a varying or fixed flow rate.

6. The method according to claim 5 , characterized in that the nitric oxide is injected into a flow of breathing gas which is provided under positive airway pressure and the nitric oxide is injected together with a carrier gas.

7. The method according to claim 4 , characterized in that the nitric oxide is injected into the breathing gas of the positive airway pressure device only when a predetermined breathing gas flow rate is exceeded or if the pressure in a patient interface falls below a predetermined pressure.

8. The method according to claim 4 , characterized in that additional oxygen is injected into the flow of breathing gas.

9. A device for the treatment of respiratory disorders, the treatment of complications arising from respiratory disorders, or the treatment of secondary respiratory disorders, said device comprising:
a positive airway pressure device for providing a breathing gas under a positive pressure to a patient interface;
a source of nitric oxide for providing gaseous nitric oxide;
a gas injector for injecting nitric oxide provided by the source of nitric oxide into the breathing gas provided by the positive airway pressure device under pressure;
a flow rate sensor for sensing the flow rate of the breathing gas provided to the patient interface under positive airway pressure; and
a controller programmed for controlling the gas injector for injecting the nitric oxide into the breathing gas provided by the positive airway pressure device when a flow rate detected by the flow rate sensor exceeds a predetermined threshold flow rate, wherein the controller is programmed to control the gas injector to inject the nitric oxide to achieve a concentration of nitric oxide in the breathing gas of between 40 ppm and 1000 ppm, and wherein the controller is programmed to control the positive airway pressure device and the gas injector to inject the nitric oxide into the breathing gas during an interval having a duration of between 1 minute to 60 minutes, with said interval provided at a frequency greater than or equal to every second day and lesser than or equal to 5 intervals a day.

10. The device according to claim 9 , characterized in that the controller is programmed to control the gas injector to inject the nitric oxide in at least one of a single pulse, in two pulses or in multiple subsequent pulses of equal or varying width, or as a constant flow with a varying or fixed flow rate.

11. The device according to claim 9 , characterized in that the controller is programmed to control the gas injector to inject the nitric oxide such that the concentration of nitric oxide in the breathing gas is between 80 ppm and 440 ppm.

12. The device according to claim 9 , characterized in that the controller is programmed to determine the onset of inspiration of a patient on the basis of the flow rate sensed by the flow rate sensor and to control the injection of the nitric oxide into the breathing gas on this basis or after a predetermined delay.

13. The device according to claim 9 , characterized in that the controller is programmed to control the positive airway pressure device and the gas injector to provide the breathing gas under positive pressure without supply

Assignees

• Linde Ag
• Linde Ag A German Corp

Inventors

• Murphy Paul
• Jafri Syed
• Schmehl Wolfgang

Classifications

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61M2016/0021

  with a proportional output signal, e.g. from a thermistor · CPC title

• A61M2016/102

  Measuring a parameter of the content of the delivered gas · CPC title

• A61M2016/1025

  the O2 concentration · CPC title

• A61M16/12 Primary

  by mixing different gases · CPC title