Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...
Reexamination Certificate
1999-09-20
2001-05-22
Fries, Kery (Department: 1751)
Cleaning compositions for solid surfaces, auxiliary compositions
Cleaning compositions or processes of preparing
For cleaning a specific substrate or removing a specific...
C510S161000, C510S162000, C510S199000, C510S226000, C510S258000, C510S382000, C510S461000, C435S264000, C134S040000
Reexamination Certificate
active
06235692
ABSTRACT:
BACKGROUND OF THE INVENTION
There exists in the prior art many aqueous cleaning solutions for industrial and commercial uses which contain a mixture of enzymes, as well as surfactants, detergents and other components. Enzymatic cleaning solutions have also been used in the past to clean various instruments, particularly medical instruments that have been soiled by exposure to materials and microorganisms present in the body cavities, tissues and blood of the surgical patient. Enzymes taught to be useful in such cleaning applications include one or more protease, amylase, lipase, cellulase and pectinase enzymes, which serve to attack or degrade organics, such as proteins, starches, fats, cellulose and pectins.
Medical and dental instruments are typically immersed in enzyme cleaners for the removal of gross soils prior to cleaning and disinfecting/sterilization. In order to effectively disinfect and/or sterilize these instruments, they must be scrupulously cleaned. The introduction of flexible glass fiber endoscopes and their growing use has created a challenge to effective cleaning. These instruments are complicated in design and contain a number of different materials. Typically the endoscopes utilize narrow lumens to transport air, liquids and surgical instruments to the interior of the human body, thereby making the instrument very difficult to clean.
Current methods of pre-cleaning medical instruments involve rinsing the instrument with water or cleaning solutions immediately after patient use. The instruments are then soaked in an enzyme solution until delivery to a central cleaning area where the instrument is disinfected and sterilized, usually by an autoclave. The enzyme soaking solution keeps the instrument moist in addition to digesting the proteinaceous, cellulosic, fat and other tissue adhering to the instrument surfaces. If the surfaces of the instrument become dry prior to cleaning, incomplete cleaning can result, which in turn may adversely impact subsequent disinfecting and/or sterilization.
There are several major drawbacks to using current immersion cleaning solutions to pre-clean complex modem medical instruments such as endoscopes. First of all, there is the tendency of the solution to splash during transport to the central cleaning area. Secondly, current enzymatic cleaning solutions typically lack antimicrobial agents to prevent growth of organisms introduced into the solution by the soiled instruments. In addition, continued use of a soaking solution tends to promote corrosion due to the variety of different materials utilized in the manufacture of the endoscopic instruments.
The present invention relates to a novel method and composition for pre-cleaning medical instruments and other devises that need to be kept moist to facilitate a final cleaning. In its preferred embodiments, a unique enzymatic cleaner is applied and maintained as a foam directly on the instrument surfaces without the need for immersion or heating.
The following are examples in the patent literature of several prior art cleaners and methods which utilize them:
Metesky et al, U.S. Pat. No. 5,462,607, Method of Cleaning Using A Foamed Liquid, teaches the use of an aqueous solution containing a surfactant and enzymes which is heated to create a foam via ebullition. This cleaner is useful for cleaning industrial equipment which has been soiled by lubricants.
Disch et al, U.S. Pat. No. 5,234,832, Process For Cleaning And Disinfecting Heat And Corrosion Sensitive Medical Instruments, teaches the use of a cleaning solution for endoscopes which contains a low-foaming nonionic surfactant, a proteolytic enzyme, a complexing agent and an aldehyde disinfectant in water having a specific hardness. The endoscope is immersed in the cleaning solution and heated to 550 C. to 650 C. for one to fifteen minutes, after which the instrument is rinsed and dried.
Disch et at, U.S. Pat. No. 5,233,166, Preparation And Processes For Cleaning And Disinfecting Endoscopes, is directed to a composition which is useful in the process described in U.S. Pat. No. 5,234,832.
Benson, U.S. Pat. No. 5,489,531, Combined Two Stage Method For Cleaning And Decontaminating Surgical Instruments, describes a method for cleaning and decontaminating soiled surgical instruments by immersing the instruments in an enzyme cleaning solution and then adding a germicidal detergent microbiological decontaminating solution.
Van Duzee et al. U.S. Pat. No. 5,576,278, Stable Liquid Enzyme Compositions And Methods of Use, teaches the cleaning of contact lenses by immersion in compositions containing opthalmically acceptable enzymes of high purity.
Smitkowski et al. U.S. Pat. No. 5,810,944 discloses a composition for cleaning surgical instruments comprising at least two C
5
-C
10
alkyl sulfate salts, at least one formulation aid such as polyethylene glycol, at least one alkanolamine and sodium sulfonate, and at least one proteolytic enzyme, along with optional conventional complexing agents and conventional preservatives.
SUMMARY OF THE INVENTION
The present invention relates to a novel method of pre-cleaning medical and other instruments using an aqueous cleaning composition which creates a long-lasting foam on the surfaces of the instrument when dispensed from a trigger spray or aerosol container. In its broadest sense, the composition of the present invention comprises: (1) an enzyme cleaning solution; (2) foam-building ingredients; (3) a corrosion inhibitor; and (4) an antimicrobial agent.
The preferred method of the invention comprises the steps of: (a) dispensing the above-described cleaning composition from a spray or aerosol container to generate a foam; (b) covering the surfaces to be cleaned with the foam; (c) maintaining the foam on the surfaces, thereby keeping the surfaces moist, digesting organic materials present on the surfaces, preventing growth of microorganisms and inhibiting corrosion of the surfaces; and (d) rinsing the foam from the surfaces prior to final cleaning and sterilization.
An object of this invention is to provide a method whereby the surfaces of medical instruments are enzymatically cleaned without immersion, while imparting corrosion inhibiting and antimicrobial properties to the instrument being treated.
Another object of this invention is to provide an enzymatic cleaning solution which, when dispensed either by trigger sprayer or aerosol spray, creates a stable foam with the above described attributes which can be applied and maintained directly on the surfaces being cleaned.
Another object of the present invention is to develop a method and composition capable of maintaining the surface of a soiled instrument in a moist condition for at least 30 minutes while promoting cleaning and disinfecting of the instrument surfaces.
Another object of the present invention is to develop a method and composition capable of repeated use with delicate instruments without corrosion of the instrument surfaces.
Another objective of this invention is to utilize known properties of thick foam for a new application, i.e. the deep pre-cleaning and moistening of medical instruments and other surfaces immediately after use, e.g. after a surgical procedure, and prior to final cleaning.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
This invention provides a cleaning composition and a method of applying said composition as a stable foam to the surface of medical instruments, as well as other equipment or tools requiring the removal of organic soil from their surfaces. As used herein, “organic soil” means residues and contaminants present on the surface of the instrument or device which are subject to enzymatic digestion and removal. While the instant invention has particular application to endoscopes, the invention may also be used to clean other surgical, medical, or dental devices and equipment, or in fact any instruments, equipment or devices, e.g., kitchen utensils, for any use where pre-cleaning organic soil from difficult surfaces and/or lumens is desired. In addition to endoscopes, examples of other medical instruments which may be
Novicova Inna A.
Scoville John R.
Cottrell International, LLC
Fries Kery
Townsend and Townsend / and Crew LLP
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