Gas systems and methods for enabling respiratory stability

• US 7,886,740 B2
• Filed: 11/18/2003
• Issued: 02/15/2011
• Est. Priority Date: 01/28/2003
• Status: Active Grant

• Current Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Original Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Inventors: Thomas, Robert J., Daly, Robert W.
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/716,360
• Publication Number:
  US 20040144383A1
• Time in Patent Office: 2,646 Days
• Field of Search: 128/204.23, 128/204.21, 128/204.18, 128/205.11, 128/205.17, 128/203.12, 128/914
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/0045 Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/203 Proportional
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: Y10S 128/914 Rebreathing apparatus for increasing carbon dioxide content in inhaled gas

Abstract

Minimal concentrations of CO2 are mixed with pressurized air to provide a gas mix effective for stabilizing breathing of target patients or users. CO2 concentrations below about 2% and preferably between about 0.5% and 1.25% are employed. A gas modulator includes a gas mixing module, a sensor and a control processor. The gas mixing module mixes plural gases, including CO2, into a gas mix, for delivery to a substantially leak-proof patient face mask. The sensor, located substantially at the face mask, measures CO2 concentration in the face mask. The control processor, based on a signal from the sensor, controls the CO2 concentration in the gas mix.

Claims

1. A positive airway pressure (PAP) device for stabilizing breathing during sleep comprising

a PAP device for sleep therapy, the PAP device further comprising

a source of medical grade carbon dioxide;

an assembly for combining pressurized air from the PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein concentration of carbon dioxide in the gas mix is less than 2%.

2. A device as claimed in claim 1 wherein the assembly includes a sensor for measuring air flow.

3. A device as claimed in claim 1 wherein the PCVSM includes any of:

a facemask, and a nasal cannula.

4. A device as claimed in claim 1 wherein concentration of carbon dioxide in the gas mix is between about 0.5% and about 1.25%.

5. A positive airway pressure (PAP) device for stabilizing breathing during sleep comprising

a PAP device for sleep therapy, the PAP device further comprising

a source of medical grade carbon dioxide;

an assembly for combining pressurized air from the PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein at least one of the source, the assembly and the PCVSM is computer processor controlled to modulate concentration of carbon dioxide in the gas mix and the computer processor modulates concentration of CO₂ in the gas mix as a function of any combination of sensed concentration of carbon dioxide in the PCVSM, sensed target state and detected system changes.

6. A method for preparing a gas mix for enabling respiratory stability for a positive airway pressure (PAP) device for sleep therapy, comprising the steps of:

providing a substantially low concentration of medical grade carbon dioxide to a PAP device used for sleep therapy;

combining pressurized air from the PAP device used for sleep therapy with the medical grade carbon dioxide to form a gas mix having stabilizing effects on breathing, the pressurized air enabling the carbon dioxide at low concentrations in the gas mix to have stabilizing effects on target respiratory systems; and

delivering the gas mix to a subject with the PAP device used for sleep therapy.

7. The method of claim 6 wherein the step of combining includes employing positive airway pressure.

8. The method of claim 6 wherein the step of combining includes utilizing a face mask worn by a target patient.

9. The method of claim 6 wherein the step of providing includes employing carbon dioxide at concentrations of less than 2%.

10. The method of claim 6 wherein the step of providing includes employing carbon dioxide at concentrations in the range of about 0.5% and about 1.25%.

11. A device for stabilizing breathing comprising a source of medical grade carbon dioxide;

an assembly for combining pressurized air from a positive airway pressure PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein at least one of the source, the assembly and the PCVSM is computer processor controlled to modulate concentration of carbon dioxide in the gas mix and the computer processor modulates concentration of CO₂ in the gas mix as a function of any combination of sensed concentration of carbon dioxide in the PCVSM, sensed target state and detected system changes.

12. A device for stabilizing breathing comprising

a source of medical grade carbon dioxidel;

an assembly for combining pressurized air from a positive airway pressure PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein at least one of the source, the assembly and the PCVSM is computer processor controlled to modulate concentration of carbon dioxide in the gas mix and the computer processor continuously receives and analyzes incoming data and indicates an alarm condition based on the incoming data and at least one of the following parameters;

maximum first gas flow;

maximum inspired first gas;

maximum arterial CO₂;

maximum end tidal carbon dioxide; and

maximum percent first gas in the mixing means,

the computer processor stopping or reducing delivery of the first gas when an alarm condition is present.

13. A device for stabilizing breathing comprising

a source of medical grade carbon dioxide;

an assembly for combining pressurized air from a positive airway pressure PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein at least one of the source, the assembly and the PCVSM is computer processor controlled to modulate concentration of carbon dioxide in the gas mix and the computer processor controls concentration of CO₂ for a patient diagnosed as having sleep disordered breathing (SDB).

14. A device for stabilizing breathing comprising

a source of medical grade carbon dioxide;

an assembly for combining pressurized air from a positive airway pressure PAP device with substantially low concentrations of the medical grade carbon dioxide resulting in a gas mix; and

a patient centric ventilatory space module (PCVSM) coupled to the assembly providing the resulting gas mix for inhalation by a given target, said inhalation of the gas mix effecting respiratory stability of said target

wherein at least one of the source, the assembly and the PCVSM is computer processor controlled to modulate concentration of carbon dioxide in the gas mix;

the source of the carbon dioxide is a pressurized source; and

the gas modulation system further comprises a control value module which regulates flow of the carbon dioxide from the pressurized source to the assembly, the control valve module responding to a control signal from the computer processor; and

the control valve module comprises a solenoid valve or a proportional valve.