BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES

• US 20110073112A1
• Filed: 10/06/2010
• Published: 03/31/2011
• Est. Priority Date: 04/10/2008
• Status: Active Grant

• Current Assignee: Seattle Children's Hospital
• Original Assignee: Seattle Children's Hospital
• Inventors: Smith, Charles V., DiBlasi, Robert M., Zignego, Jay C., Hansen, Thomas N., Richardson, Peter
• Granted Patent: US 8,499,759 B2
• Time in Patent Office: Days
• US Class Current: 128/205.24
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• 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 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/025 Helium
• CPC Class Codes: A61M 2202/0266 Nitrogen (N)
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3348 Pressure measurement using a water column
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities

Abstract

It has been discovered that high amplitude, low frequency, broadband spectrum pressure oscillations of sufficient time duration can help stabilize lung volumes and improve gas exchange in a patient receiving ventilation assistance by helping to recruit and stabilize alveoli. A novel device is presented which can produce pressure oscillations having high amplitudes, a low broad-band frequency spectrum and long time duration. Additionally, the device can maintain a patient'"'"'s mean airway pressure at one or more controlled levels. The device can control the oscillatory amplitude, frequency range and composition, time duration, and mean airway pressure levels by adjusting certain device parameters, such as the angle and depth of the device in a fluid. A device and mechanical system for remotely adjusting and measuring the angle of the device in a fluid are also disclosed. Furthermore, a device and system are disclosed that can deliver pressure oscillations having high amplitudes, a low broad-band frequency spectrum, long time duration, and multiple mean airway inspiratory and expiratory pressure levels. The device and system also provide means for controlling respiration timing in a patient, including: breaths per minute, inspiratory time, and the ratio of inspiratory to expiratory time.

Claims

1. A pressure regulating breathing assistance apparatus comprising:

a pressurized gas source;

a container comprising fluid; and

a conduit including proximal and distal ends, the proximal end adapted for connection to the pressurized gas source, the conduit also adapted for connection to a patient interface intermediate the proximal and distal ends, wherein the distal end further comprises;

(i) at least one peak inspiratory pressure control conduit adapted for connection to the conduit and configured to be submerged in the body of fluid at varying depths;

(ii) at least one positive end-expiratory pressure control conduit adapted for connection to the conduit and configured to be submerged in the body of fluid at varying depths; and

(iii) a valve intermediate the at least one peak inspiratory pressure control conduit and the at least one positive end-expiratory pressure control conduit.

2. The pressure regulating breathing assistance apparatus of claim 1, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is substantially circular having an inside diameter of between about 1-3 cm, between about 1.2-2.0 cm, between about 1.3-1.8 cm, between about 1.4-1.6 cm, or about 1.5cm.

3. The pressure regulating breathing assistance apparatus of claim 1, wherein an angled portion of the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit has a length of between about 5-12 cm, between about 6-11 cm, between about 7-10 cm, between about 8-9.5 cm, or about 9 cm.

4. The pressure regulating breathing assistance apparatus of claim 1, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is submerged to a depth of about between 3-200 cm, between about 5-11 cm, about 5 cm, about 7 cm, about 9 cm, or about 11 cm.

5. The pressure regulating breathing assistance apparatus of claim 1, wherein the fluid has a density of between about 0.5-1.5 g/cm3 at 20°

C.

6. The pressure regulating breathing assistance apparatus of claim 1, wherein the fluid is water.

7. The pressure regulating breathing assistance apparatus of claim 1, wherein the peak inspiratory pressure control conduit is configured to produce an oscillating pressure wave having more than 50% of its average power spectra occur below about 7 Hz when the bias flow of gas is at least 2 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

8. The pressure regulating breathing assistance apparatus of claim 1, wherein the peak inspiratory pressure control conduit is configured to produce an oscillating pressure wave having more than 50% of its average power spectra occur between about 2-5 Hz when the bias flow of gas is 2 L/min and 1-9 Hz when the bias flow of gas is 12 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

9. The pressure regulating breathing assistance apparatus of claim 1, wherein the peak inspiratory pressure control conduit is configured to produce airway pressure oscillation frequencies of between about 1-10 Hz, between about 2-9 Hz, between about 2-7 Hz, or between about 2-5 Hz when the bias flow is 6 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

10. The pressure regulating breathing assistance apparatus of claim 1, wherein the peak inspiratory pressure control conduit is configured to deliver an average volume of gas greater than about 3.0 ml when the bias flow of gas is 8 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

11. The pressure regulating breathing assistance apparatus of claim 1, further comprising a conduit swivel member at the distal end of the conduit configured to adjust the angle of the distal end of the conduit with respect to the vertical axis.

12. The pressure regulating breathing assistance apparatus of claim 1, wherein the distal end of the at least one peak inspiratory pressure control conduit or the at least one positive end-expiratory pressure control conduit has any angle except 0 and 90 degrees with respect to a vertical axis, wherein the device is configured to produce a high amplitude, low frequency broadband oscillating pressure wave having more than 50% of its average power spectra occur below about 7 Hz when the bias gas flow is at least 2 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

13. The pressure regulating breathing assistance apparatus of claim 1, wherein the distal end of the positive end-expriratory pressure control conduit is angled greater than 90 degrees with respect to a vertical axis.

14. The pressure regulating breathing assistance apparatus of claim 13, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is angled greater than or equal to between about 91-170 degrees, between about 95-165 degrees, between about 100-160 degrees, between about 105-155 degrees, between about 110-150 degrees, between about 115-145 degrees, between about 120-140 degrees, between about 125-135 degrees, between about 130-140 degrees, or about 135 degrees with respect to a vertical axis.

15. The pressure regulating breathing assistance apparatus of claim 14, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is angled to about 135 degrees with respect to a vertical axis.

16. The pressure regulating breathing assistance apparatus of claim 12, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is substantially circular having an inside diameter of between about 1-3 cm, between about 1.2-2.0 cm, between about 1.3-1.8 cm, between about 1.4-1.6 cm, or about 1.5 cm.

17. The pressure regulating breathing assistance apparatus of claim 12, wherein the angled portion of the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit has a length of between about 5-12 cm, between about 6-11 cm, between about 7-10 cm, between about 8-9.5 cm, or about 9 cm.

18. The pressure regulating breathing assistance apparatus of claim 12, wherein the distal end of the peak inspiratory pressure control conduit or the end-expriratory pressure control conduit is submerged to a depth of about between 3-200 cm, between about 5-11 cm, about 5 cm, about 7 cm, about 9 cm, or about 11 cm.

19. The pressure regulating breathing assistance apparatus of claim 12, wherein the fluid has a density of between about 0.5-1.5 g/cm3 at 20°

C.

20. The pressure regulating breathing assistance apparatus of claim 12, wherein the fluid is water.

21. The pressure regulating breathing assistance apparatus of claim 12, wherein the peak inspiratory pressure control conduit is configured to produce an oscillating pressure wave having more than 50% of its average power spectra occur below about 7 Hz when the bias flow of gas is at least 2 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

22. The pressure regulating breathing assistance apparatus of claim 12, wherein the peak inspiratory pressure control conduit is configured to produce an oscillating pressure wave having more than 50% of its average power spectra occur between about 2-5 Hz when the bias flow of gas is 2 L/min and 1-9 Hz when the bias flow of gas is 12 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

23. The pressure regulating breathing assistance apparatus of claim 12, wherein the peak inspiratory pressure control conduit is configured to produce airway pressure oscillation frequencies of between about 1-10 Hz, between about 2-9 Hz, between about 2-7 Hz, or between about 2-5 Hz when the bias flow is 6 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

24. The pressure regulating breathing assistance apparatus of claim 12, wherein the peak inspiratory pressure control conduit is configured to deliver an average volume of gas greater than about 3.0 ml when the bias flow of gas is 8 L/min in a model test lung system comprising a hermetically sealed silastic lung within a calibrated plethysmograph.

25. The pressure regulating breathing assistance apparatus of claim 11, wherein the conduit swivel member further comprises a plurality of marks that indicate the angle of the distal end of said conduit with respect to the vertical axis.

26. The pressure regulating breathing assistance apparatus of claim 11, wherein the conduit swivel member is automated such that a user can manually or automatically adjust the angle of said distal end of said conduit with respect to the vertical axis.

27. The pressure regulating breathing assistance apparatus of claim 26, further comprising a computer configured to operate said swivel member upon user instruction and thereby automatically adjust the angle of said distal end of said conduit with respect to the vertical axis.

28. A method for providing continuous positive airway pressure with oscillating positive end-expiratory pressure to a subject, comprising:

providing a pressure regulating breathing assistance apparatus as set forth in claim 1;

releasing gas from said pressurized gas source into said conduit of said pressure regulating breathing assistance apparatus; and

delivering said gas to said subject.

29. A method for providing continuous positive airway pressure with oscillating positive end-expiratory pressure to a subject, comprising:

providing a pressure regulating breathing assistance apparatus as set forth in claim 12;

releasing gas from said pressurized gas source into said conduit of said pressure regulating breathing assistance apparatus; and

delivering said gas to said subject.