Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1998-10-26
2001-04-03
Thornton, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C252S186300, C422S028000, C422S030000, C422S034000, C435S001200, C514S839000, C514S840000
Reexamination Certificate
active
06210639
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to disinfection and cleaning systems for medical devices. In a preferred embodiment, the invention relates to compositions, methods and articles for simultaneously cleaning and disinfecting contact lenses.
2. Description of the Related Art
The medical arts include a wide variety of systems for cleaning and disinfecting articles. Disinfectant systems range from the harsh, such as chlorine bleach for surgical tools, to the mild, preservative range, such as boric acid or quaternary ammonium polymers for contact lenses. Typically, a specific medical device and its use will dictate specific requirements for disinfecting and cleaning, although many requirements are common for all medical devices.
A particularly difficult field in which to design disinfecting and cleaning systems is the field of ophthalmics, which relates to articles which have intimate contact with ocular tissue and fluids. Ophthalmic articles include vision-correcting contact lenses, ocular wound healing coverings, intraocular lenses, ophthalmic drug delivery devices and the like. Clearly, ophthalmic article disinfecting and cleaning systems must balance several factors.
For example, contact lens cleaning and disinfecting systems must both sufficiently disinfect adhered microorganisms for safe use and sufficiently clean or remove adhered protein and lipids for good visual acuity. Also, consumer convenience is a major factor, requiring such systems to be rapid, involve minimal consumer manipulation, and be easy to store and transport. Of course, overall system cost is also a significant concern. In addition, lens polymer interactions must be minimized (e.g., disinfectant adsorption and release rates, lens discoloring, polymer decomposition, lens shape alteration and visual distortion). Moreover, ophthalmic compatibility is an overriding concern, and this compatibility includes not only cell toxicity but also ocular comfort. Furthermore, disinfectants may deactivate cleaners, and vice versa, or the operating conditions of each may not coincide. In view of these and other competing factors, development of a successful contact lens cleaning and disinfecting system is highly complex, and there remains a need for a system which balances all of these factors.
SUMMARY OF THE INVENTION
An object of the invention is to provide a simultaneous cleaning and disinfecting system for medical devices.
Another object of the invention is to provide a rapid, convenient, efficacious simultaneous cleaning and disinfecting system for contact lenses.
A further object of the invention is to provide a system for cleaning and disinfecting ophthalmic lenses in less than 30 minutes.
Yet another object of the invention is to provide a system for cleaning and disinfecting ophthalmic lenses which can be used with tap water.
One embodiment of the invention is a cleaning and disinfecting system which includes a dosage form or tablet which can be dissolved in a saline solution within a container. The dosage form includes a cleaning and disinfecting portion and a portion which neutralizes the cleaner and disinfectant. The disinfectant which is provided in the dosage form, or generated in situ, is peracetic acid.
In a preferred embodiment of the invention, the cleaning and disinfecting portion of the dosage form includes a peroxide-generating species and an N,N-diacylamide activator to generate peracetic acid in situ. The cleaning and disinfecting portion further includes effervescent additives to increase the dissolution rate and uniformity of concentration profile. Additionally, the cleaning and disinfecting portion includes an amount of enzyme sufficient to remove lipids and proteins from the article to be cleaned. The neutralizing portion includes means for neutralizing the peracetic acid and enzyme.
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Boam Christopher Roy
Cooper Stephen Dennis
George Ian Michael Riorden
Vlass Elizabeth Gayle
Gorman Jr. Robert J.
Meece R. Scott
Novartis AG
Thornton Krisanne
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