Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...
Reexamination Certificate
1999-06-18
2001-03-13
Kopec, Mark (Department: 1751)
Cleaning compositions for solid surfaces, auxiliary compositions
Cleaning compositions or processes of preparing
For cleaning a specific substrate or removing a specific...
C510S245000, C510S254000, C510S363000, C510S398000, C510S421000, C510S434000, C510S477000, C510S533000, C134S042000
Reexamination Certificate
active
06200939
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to biocompatible cleaning and deodorizing compositions for medical devices, and more particularly to compositions for cleaning and deodorizing medical devices which are designed for receiving and/or holding human waste. Preferably, the compositions are free of non-biocompatible or toxic components and have a relatively neutral pH, whereby the compositions are not harmful to human skin upon contact.
BACKGROUND OF THE INVENTION
Medical devices known generally as ostomy appliances, and more specifically as colostomy, ileostomy and urostomy appliances or bags, are designed to receive and contain human metabolic wastes when the natural routes of elimination of these bodily wastes have been circumvented, either temporarily or permanently by surgical intervention such as ileostomy, colostomy, urostomy or the like and/or during processes such as catheterization, wound drainage, or the like. Similarly, medical devices generally known as incontinence appliances, and more specifically as urinary and fecal collection appliances or bags, are designed to receive and contain human metabolic wastes, such as urine and feces.
Ostomy and incontinence appliances are carefully engineered to provide patient comfort, safety, ease of use and security against leakage of the contents into the environment, and typically include valves to prevent siphoning effects and provide for easy emptying of the appliances. The majority of appliances in use today are made of strong, pliable, non-toxic, hypoallergenic plastic polymers or natural or synthetic rubbers. These devices are needed on a continual basis by many patients and typically represent a significant expense to the user. As is apparent, the per use cost of an ostomy or incontinence appliance decreases as the number of uses increases. Accordingly, as an ostomy or incontinence appliance becomes full during use, it is typically emptied by either the user or a care giver and then re-attached to the evacuation site for re-use, thereby reducing replacement costs.
Unfortunately, the useful life of an ostomy or incontinence appliance is often limited as substances present in human waste can soil and stain the appliance, obstruct valves and flow paths, and/or cause intense odors which absorb to the surfaces of tide appliance and escape into the environment. The bad odors which are typically associated with the use of ostomy and incontinence appliances often represent a serious threat to the psychological well being of the users and cause them to isolate from society. It is therefore desirable to clean ostomy and incontinence appliances before re-use. This not only requires extra effort for the user or care giver, but prior art ostomy and incontinence appliance cleaning compositions have generally been found to be essentially ineffective and even potentially dangerous to use.
For example, the conventional cleaning compositions are typically cumbersome to use as they contain strong acids which can burn the skin and eyes upon contact during use. Additionally, if even traces of the strong acids remain on the exterior surfaces of the appliance, they can cause skin irritation to the user. Moreover, the conventional compositions are typically only marginally effective in actually cleaning the appliance, and none of the commercially available compositions which the present inventor is aware of are effective against the primary causes of appliance failure, namely malodor, staining, and clogging of the valves and other flow mechanisms. As a result, many users replace the appliance daily, without reuse, and thereby incur significant costs, or attempt to clean the appliances with generally ineffective home remedies such as vinegar and water.
Accordingly, a need exists for improved cleaning and deodorizing compositions for use in cleaning medical devices, particularly ostomy and incontinence appliances and the like, which are both effective and easily and safely employed to allow reuse of the devices.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide improved cleaning and deodorizing compositions. It is an additional object of the present invention to provide biocompatible cleaning and deodorizing compositions which overcome disadvantages of the prior art. It is a more specific object of the invention to provide biocompatible cleaning and deodorizing compositions which are suitable for use in cleaning and deodorizing medical devices, for example ostomy and incontinence appliances, and thereby allow reuse of the devices. It is a further object of the invention to provide such compositions which are safe for use in environments where contact of the compositions with humans is anticipated or not easily prevented.
These and additional objects are provided by the biocompatible cleaning and deodorizing compositions of the present invention. More particularly, the invention is directed to biocompatible aqueous cleaning and deodorizing compositions comprising (i) a biocompatible high osmotic pressure material, (ii) a polycarboxylic acid salt, (iii) a polyhydric alcohol, (iv) a nonionic surfactant, and (v) an odor elimination agent., in water. Preferably, the aqueous biocompatible cleaning and deodorizing compositions comprise, by weight, (i) from about 2% to about 20% of the biocompatible high osmotic pressure material, (ii) from about 2% to about 20% of the polycarboxylic acid salt, (iii) from about 2% to about 20% of the polyhydric alcohol, (iv) from about 0.1% to about 10% of the nonionic surfactant, and (v) from about 0.1% to about 10% of the odor elimination agent, in water. That the compositions are biocompatible means that, upon contact with normal human or animal tissue, the compositions do not cause a detectable alteration of the normal structure or function of the tissue.
The invention is further directed to articles of manufacture in the form of kits for cleaning and deodorizing a device. The kits comprise (a) a first container provided with a concentrated aqueous biocompatible cleaning and deodorizing composition comprising (i) a biocompatible high osmotic pressure material, (ii) a polycarboxylic acid salt, (iii) a polyhydric alcohol, (iv) a nonionic surfactant, and (v) an odor elimination agent, in water, and (b) a second container for receiving a portion of the concentrated aqueous composition and a diluting amount of water. The second container is provided with means for measuring the portion of concentrated aqueous composition to be received therein and a dispenser for dispensing a diluted aqueous cleaning and deodorizing composition therefrom.
In an additional embodiment, the invention is directed to methods for cleaning and deodorizing a medical device, for example an ostomy or incontinence appliance. The methods comprise applying to the device an aqueous biocompatible cleaning and deodorizing composition comprising (i) a biocompatible high osmotic pressure material, (ii) a polycarboxylic acid salt, (iii) a polyhydric alcohol, (iv) a nonionic surfactant, and (v) an odor elimination agent, in water.
The compositions, articles of manufacture and methods according to the present invention are advantageous in that they are effective in cleaning and deodorizing medical devices, including, but not limited to, devices adapted for receiving or holding human waste such as ostomy and incontinence appliances, and are free of non-biocompatible or toxic components and have a relatively neutral pH, whereby the compositions are not harmful to human skin upon contact.
These and additional objects and advantages provided by the compositions, articles of manufacture and methods of the present invention will be more fully apparent in view of the following detailed description.
DETAILED DESCRIPTION
The present invention is directed to biocompatible cleaning and deodorizing compositions for medical devices, and more particularly to compositions for cleaning and deodorizing medical devices which are designed for receiving and/or holding human waste. It is believed that the present composi
Dinsmore & Shohl LLP
Kopec Mark
Mruk Brian P.
National Research Labs
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