Pressure actuated valve systems and methods

• US 10,265,495 B2
• Filed: 03/05/2014
• Issued: 04/23/2019
• Est. Priority Date: 11/22/2013
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Voss, Greg, Lurie, Keith, Metzger, Anja
• Primary Examiner(s): Philips, Bradley H
• Application Number:
  US14/197,996
• Publication Number:
  US 20150144138A1
• Time in Patent Office: 1,875 Days
• CPC Class Codes: A61M 16/0009 with sub-atmospheric pressure, e.g. during expiration
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

Systems and methods are provided for decreasing intracranial pressure and enhancing circulation, as well as for increasing the respiratory rate and encouraging spontaneous respiration. According to such methods, a valve system is coupled with a person'"'"'s airway. The valve system has an exhalation valve and an patient port that interfaces with the person'"'"'s airway. The exhalation valve includes a diaphragm having a textured surface. The diaphragm is positioned across an exhalation valve seat and contacts a distal end of the exhalation valve seat, and is configured to prevent or impede respiratory gas flow to the person'"'"'s lungs until an expiratory pressure equals or exceeds an opening pressure of the exhalation valve, at which time the diaphragm moves away from the distal end to create an open exhaust channel.

Claims

1. A system for regulating intrathoracic pressure, the system comprising:

a valve system that is configured to be coupled with a person'"'"'s airway, the valve system having an exhalation valve, a threshold valve, and a patient port that interfaces with the person'"'"'s airway, wherein;

the exhalation valve comprises a diaphragm and an exhalation valve seat,

the exhalation valve is configured to retain an intact seal between the diaphragm and a distal end of the exhalation valve seat during inspiration and until an expiratory pressure of the person'"'"'s airway during expiration equals or exceeds an opening pressure of the exhalation valve, at which time the diaphragm separates from the distal end to create an open exhaust channel between the diaphragm and the distal end, the open exhaust channel permitting expiratory gas flow from the person'"'"'s airway therethrough,

the diaphragm is configured to provide a predictable opening pressure while limiting leakage of incoming respiratory gases through the exhalation valve during inspiration or a negative intrathoracic pressure to an acceptable leakage rate of below 0.05 lpm at about −

5 cm H₂O and when the diaphragm contacts the distal end, and the threshold valve is configured to prevent or impede respiratory gas flow to the person'"'"'s lungs until an opening pressure of the threshold valve is exceeded, and

the threshold valve comprising a check valve configured to facilitate opening of the threshold valve at the opening pressure of the threshold valve, and wherein;

the system comprises a textured surface comprising a plurality of bumps and/or grooves and configured to facilitate opening of the exhalation valve on either a surface of the diaphragm that contacts the distal end of the exhalation valve seat or the distal end of the exhalation valve seat, and/or

the system comprises a textured surface comprising a plurality of bumps or grooves and configured to facilitate opening of the threshold valve on a surface of the gasket facing a valve seat of the threshold valve or on the valve seat of the threshold valve.

2. The system according to claim 1, wherein the textured surface comprises a standard texture having a value of MT-11000.

3. The system according to claim 1, wherein the opening pressure of the exhalation valve has a value within a range from 0 cm H₂O to 8 cm H₂O.

4. The system according to claim 1, wherein the opening pressure of the exhalation valve has a value between about 0 cm H₂O and 0.5 cm H₂O.

5. The system according to claim 1, wherein the opening pressure of the exhalation valve is relative atmospheric pressure or greater.

6. The system according to claim 1, wherein the threshold valve is configured to produce a pressure that is represented by a square pressure waveform during an inspiration phase.

7. The system according to claim 1, wherein the threshold valve is configured to provide a peak intrathoracic pressure of about −

8 cm H₂O or less during an inspiration phase.

8. The system according to claim 1, wherein the threshold valve is configured to provide an intrathoracic pressure plateau of about −

5 cm H₂O or less during an inspiration phase.

18. The system according to claim 1, wherein the diaphragm comprises a material having a durometer that provides a predictable opening pressure.

9. A pressure actuated valve for use in an intrathoracic pressure regulation system, the valve comprising:

a conduit having a distal end that is substantially planar in geometry; and

a diaphragm that is positionable against the distal end to create an interface between at least a portion of the diaphragm and at least a portion of the distal end, wherein one of the portion of the diaphragm and the portion of the distal end comprises a textured surface comprising a plurality of bumps and/or grooves at the interface, wherein the textured surface is configured to provide a predictable opening pressure while limiting leakage of incoming respiratory gases through the exhalation valve during inspiration or a negative intrathoracic pressure to an acceptable leakage rate of below 0.05 lpm at about −

5 cm H₂O and when the diaphragm contacts the distal end;

wherein the diaphragm is configured to separate from the distal end, thus breaching the interface, to allow gases to flow between the diaphragm and the distal end when an expiratory pressure within the conduit is greater than 0 cm H₂O.

10. The pressure actuated valve according to claim 9, wherein the textured surface comprises a texture depth having a value within a range between 0.0005 and 0.001 inches.

11. A method of regulating intrathoracic pressure, the method comprising:

interfacing a valve system to a person'"'"'s airway, the valve system having an exhalation valve, a threshold valve, and a patient port that interfaces with the person'"'"'s airway, wherein;

the exhalation valve comprises a diaphragm and an exhalation valve seat,

the exhalation valve is configured to retain an intact seal between the diaphragm and a distal end of the exhalation valve seat during inspiration and until an expiratory pressure of the person'"'"'s airway during expiration equals or exceeds an opening pressure of the exhalation valve, at which time the diaphragm separates from the distal end to create an open exhaust channel between the diaphragm and the distal end, the open exhaust channel permitting expiratory gas flow from the person'"'"'s airway therethrough,

the diaphragm is configured to provide a predictable opening pressure while limiting leakage of incoming respiratory gases through the exhalation valve during inspiration or a negative intrathoracic pressure to an acceptable leakage rate of below 0.05 lpm at −

5 cm H₂O and when the diaphragm contacts the distal end, and the threshold valve is configured to prevent or impede respiratory gas flow to the person'"'"'s lungs until an opening pressure of the threshold valve is exceeded, and

the threshold valve comprising a check valve gasket configured to facilitate opening of the threshold valve at the opening pressure of the threshold valve, and wherein;

the system comprises a textured surface comprising a plurality of bumps and/or grooves and configured to facilitate opening of the exhalation valve on either a surface of the diaphragm that contacts the distal end of the exhalation valve seat or the distal end of the exhalation valve seat, and/or

the system comprises a textured surface comprising a plurality of bumps and/or grooves and configured to facilitate opening of the threshold valve on a surface of the gasket facing a valve seat of the threshold valve or on the valve seat of the threshold valve.

12. The method of claim 11, wherein the impeded respiratory gas comprises outflowing respiratory gas during a period of expiration.

13. The method according to claim 11, wherein the opening pressure comprises relative atmospheric pressure or greater.

14. The method according to claim 11, wherein the predictable opening pressure comprises a range of pressure values extending between a minimum value and a maximum value such that a difference between the minimum value and the maximum value does not exceed about 0.5 cm H₂O.

15. The method according to claim 11, further comprising performing cardiopulmonary resuscitation on the person by repeatedly compressing the person'"'"'s chest.

16. The method according to claim 15, further comprising actively lifting the person'"'"'s chest between compressions.

17. The method according claim 11, wherein the person is breathing, and wherein the exhalation valve prevents or impedes respiratory gas flow from the person'"'"'s airway until the expiratory pressure of the person'"'"'s airway equals or exceeds the opening pressure of the exhalation valve.