Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Reexamination Certificate
2000-05-02
2003-04-01
Lewis, Aaron J. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
C604S295000, C604S301000
Reexamination Certificate
active
06540726
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an eyewash dispensing apparatus for providing emergency liquid irrigation to an eye. More specifically, the invention relates to a sealing system for an eyewash delivery apparatus that provides a clean sterile and aseptic environment and is tamper evident.
BACKGROUND OF THE INVENTION
In the USA, federal regulations, such as regulations of the Occupational Safety and Health Agency (OSHA) stipulate that where the eyes of a person may be exposed to injurious, corrosive materials, suitable facilities for rapid irrigation or flushing of the eyes or body should be provided. An eyewash system must be within the work area for immediate emergency use. In addition to the OSHA regulations, the eyewash systems have to meet other standards, such as for example, the ANSI standards which are typically applicable to those systems connected directly to a building plumbing network. According to the ANSI standards, eyewash systems must be capable of delivering 0.4 gallons per minute of irrigation liquid for 15 minutes of continuous use. These eyewash systems must also permit the user to hold both eyelids open while flushing both eyes simultaneously. Known portable or personal eyewash systems do not usually meet these standards. Such systems are typically intended to deliver initial or supplemental first aid in the absence of a readily available plumbed eyewash facility. Portable eyewash systems are often used until further emergency medical treatment can be provided on site or are used on route to a local hospital. The ANSI standard recommends the use of a preserved, buffered saline solution in all emergency eyewash devices, both self-contained and directly plumbed.
Emergency eyewash devices for dispensing liquids to the eye are in wide use in factories and other industrial installations where the danger of injury to the eye exists due to splashing of chemicals, dust, dirt, metal filings and other irritants which may be present. One type of prior art device has generally included a resilient container filled with liquid, a simple threaded closure encapsulated in a heat shrink tamper evident seal or a tamper evident band located between the closure and container. Another type of prior art device is in the form of an empty squeezeable container, and adapter for the eye, such as an eye-cup and a cover for the eye-cup, such as a cap. The container, eye-cup and cap are formed without an integral sealing system. In this instance, the container must be filled separately and refilled every few months to minimize contamination. A further type of prior art device is in the form of a filled squeezeable container, an adapter for the eye, such as an eye-cup and a cover for the eye-cup, such as a cap. The container, eye-cup and cap are formed without an integral sealing system. This type of eyewash device is subject to leaks developed during shipping and handling. To minimize contamination it also has to be constantly refilled.
One such prior art device is disclosed by U.S. Pat. No. 3,917,119 to Kahn. The contents of which are specifically herein incorporated by reference. Upon squeezing the container, the liquid is forced through the tube to the eye cup for irrigating, rinsing, flushing, cleaning or otherwise relieving the eye of the irritant. The prior art devices, while performing the function of flushing the eye with liquid, are disadvantageous in that they are difficult to liquid seal in an clean or aseptic manner that is tamper evident. It is important that the liquid applied to the eye be in a sterile condition. The seal on an emergency eyewash device should keep the liquid contents in a sterile or preserved condition during long periods of storage before use. Further, any sealing device must be quickly and readily removable because any delay in the application of the irrigation liquid may result in additional damage to the affected tissues in the eye. In an emergency situation any delay in applying the eyewash liquid to the eye is detrimental to the health of the user.
Thus, it is an object of the invention to provide a personal eyewash delivery apparatus having a dual sealing system which is leak proof during shipping and handling. Another object of the invention is to provide an eyewash apparatus having one step removal of an internal and external sealing arrangements. It is a further object of the invention to provide an eyewash apparatus with the sealing system having improved shelf life for both sterile and preserved eyewash irrigation fluids.
SUMMARY OF THE INVENTION
The present invention provides a sealing system for an eyewash delivery apparatus that is sterile or aseptic and tamper evident. One aspect of the present invention provides a seal for an eyewash apparatus that is operated by a user. The eyewash apparatus has a fluid reservoir, an eye-cup attached to the fluid reservoir and an irrigation liquid contained within the fluid reservoir. A cap that is located over and in surrounding relationship to the eye-cup. A seal or gasket is located between the cap and the eye-cup to seal the irrigation liquid within the eyewash apparatus. A pull tab is attached to the cap and extends outwardly. The pull tab removes the cap from the eye-cup when actuated by the user. Another aspect of the present invention provides for several spray nozzles that are located within the eye-cup. The spray nozzles are in communication with the fluid reservoir.
Still another aspect of the present invention provides for a drain tube which passes through the eye-cup. The pull tab having a plug that extends into the drain tube to seal the drain tube and to keep the irrigation liquid within the eye-cup. The plug is removed from the drain tube when the pull tab is actuated by the user.
A further aspect of the present invention provides a conforming cover that extends over the cap and the eye-cup. The conforming cover partially covers the pull tab and is readily removable when the pull tab is actuated by the user. The conforming cover is perforated to allow for easy removal by the user and is formed from a shrink wrap material.
Still further aspect of the present invention provides an outer rim associated with the cap for holding the cap to the eye-cup.
The cup and seal are removed by the user by pulling outwardly and upwardly on the grasping portion of the pull tab. As the pull tab is pulled, it breaks through the parallel perforations of the shrink wrap material. As the user continues to pull on the pull tab, the pull tab is bent upwardly and a plug is removed from the drain tube. The plug prevents any irrigation fluid that may have entered the eye-cup from leaking during storage. As the user continues to lift on the pull tab, the lip is pulled away from the eye-cup upper end resulting in the cap moving above the eye-cup. At the same time, the gasket is removed from the spray nozzles and the boss slides away from the discharge end. The user continues to lift on the seal until both the cap and the shrink wrap material are removed from the eye-cup. The eyewash apparatus is now exposed and ready to use.
The design of the present invention provides for an easy to manufacture leakproof seal that has improved performance. The seal prevents irrigation fluid from exiting the eyewash apparatus. The seal maintains the eye-cup and irrigation fluid in a clean, sterile and aseptic condition. The seal serves as a prevention device against any tampering that may be attempted on the eyewash apparatus. Any breaks in the shrink wrap material are indicative of possible tampering. The seal's ability to be rapidly removed does not impede its use during an emergency.
REFERENCES:
patent: 1623454 (1927-04-01), Wilson
patent: 1692143 (1928-11-01), Strunz
patent: 1846763 (1932-02-01), Schaefer
patent: D104881 (1937-06-01), Rosengart
patent: 2920624 (1960-01-01), Lerner et al.
patent: 3917119 (1975-11-01), Kahn
patent: 5295981 (1994-03-01), Smith et al.
patent: 5320615 (1994-06-01), Van Keuren
patent: 5387202 (1995-02-01), Baron
patent: 5588564 (1996-12-01), Hutson et al.
patent: 5904259 (1999-
Follman Mark
Landsberger David
Thom Paul
Bel-Art Products Inc.
Fridman Lawrence G.
Lewis Aaron J.
Truong Linh
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