Fluid handling – Systems – With flow control means for branched passages
Reexamination Certificate
2001-01-02
2002-05-14
Fox, John (Department: 3753)
Fluid handling
Systems
With flow control means for branched passages
C128S205240
Reexamination Certificate
active
06386235
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to improvements in valves for pressurized gas cylinders and more particularly pertains to new and improved oxygen cylinder charging and dispensing valves.
2. Description of Related Art
In-home healthcare oxygen concentrators and ambulatory oxygen cylinder systems are being utilized to provide oxygen to patients who require supplemental oxygen due to cardiopulmonary disease. In the United States, the Food and Drug Administration (FDA) regulates oxygen concentrators and ambulatory oxygen cylinders. The FDA requires that the ambulatory cylinders may be refilled by home healthcare providers that are required to follow United States Pharmacopoeia (USP) standard UN 1072. These cylinders are filled through a compressed gas association (CGA) 870 filling port which has become a standard in the industry. As a result, secondary devices that need to be attached to the cylinder, for example, a pressure regulating device or an oxygen conserving device are designed for attachment to the CGA-870 port.
The FDA, through its regulations, requires that in-home oxygen concentrators or other oxygen generating devices can not fill an ambulatory oxygen cylinder through a CGA-870 port. Only home healthcare providers who follow the USP UN 1072 standards may utilize the CGA-870 port to fill ambulatory oxygen cylinders. The FDA does allow oxygen concentrating devices to fill ambulatory oxygen cylinders but only through a unique filling port which is not compatible with the CGA-870 port. This requirement insures that the ambulatory oxygen cylinders will only contain gas produced by the oxygen-concentrating devices. Moreover, the unique fill port required must be labeled accordingly, i.e., for use only with oxygen-concentrating devices.
The CGA-870 post valves which are an industry standard are used extensively for portable oxygen cylinders. Leading manufacturers of such post valves are the Sherwood Division of Harsco Corporation of Lockport, N.Y., Thermo Valves Corporation of Santa Rosa, Calif. and Condon Manufacturing Co., Inc. of Springfield, Mass. These CGA-870 post valves permit dispensing and charging of the cylinder, through the valve. A large variety of attachments are available on the marketplace for these valves.
Because of the FDA requirement that oxygen concentrating devices such as are available for in-home stationary use cannot be made attachable to a CGA-870 port, the cylinders that are fillable by these in-home oxygen concentrators utilize a valve with a unique fill port. This valve with the unique fill port requires a special built-in regulator. An off-the-shelf regulator can not be used because these regulators are adapted to fit the CGA-870 port. Special built-in regulators multiply the cost of the cylinder valve, thereby increasing the cost of each ambulatory oxygen cylinder. Moreover, use of a unique fill port valve greatly reduces a patient's choices of attachments to the cylinder.
None of the prior art devices have solved the problem of addressing the FDA regulation that only a unique fill port is used on oxygen concentrating devices to fill ambulatory oxygen cylinders, while at the same time providing a CGA-870 port on the valve.
SUMMARY OF THE INVENTION
The present invention provides a valve assembly for attachment to an ambulatory oxygen cylinder which is adapted to connect to a high pressure source that delivers oxygen concentrated air to charge the cylinder through a unique fill port, while at the same time providing an industry standard CGA-870 output port. The valve assembly will not permit filling the cylinder through the CGA-870 port. The CGA-870 port is useable only to dispense oxygen from the cylinder.
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McCulloh Kevin Gene
Sanchez Oscar J.
Chad Therapeutics
Fox John
Price and Gess
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