Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1999-12-06
2002-11-05
Warden, Sr., Robert J. (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S035000, C427S002100
Reexamination Certificate
active
06475434
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition for coating or cleaning medical devices that are likely to become contaminated or have become contaminated with microorganisms and methods for preventing biofilm embedded microorganisms from growing, or proliferating, on the surface of medical devices, and for removing biofilm embedded microorganisms growing, or proliferating, on the surface of medical devices.
2. Description of Related Art
As a defense to antimicrobial agents and other environmental hazards which may affect the survival and proliferation of microorganisms, microorganisms form a defense layer called biofilm. Formation of biofilm on the surface of various medical devices can be detrimental to the integrity of the medical device, present health risks, and prevent sufficient flow through the lumens of medical devices.
Although coating or cleaning medical devices with antimicrobial agents, e.g., antibiotics or antiseptics, can be effective in killing or inhibiting growth of planktonic organisms on the surfaces of such items, the antimicrobial agents are generally much less active against the microorganisms that are deeply embedded within the biofilm. The failure of the antimicrobial agents to sufficiently remove the microorganisms is in part due to the shielding effect of the biofilm. The biofilm prevents penetration of the antimicrobial agents deep into the biofilm to kill the microorganisms residing therein.
Accordingly, prior to the development of the present invention, there has been no biofilm penetrating composition, method for coating medical devices, method for removing biofilm embedded microorganisms from at least one surface of medical devices, or coated medical device, which: provides disruption of the biofilm thereby allowing antimicrobial agents and/or antifungal agents to penetrate the biofilm and remove biofilm embedded microorganisms from the surface of medical devices; and prevents the growth or proliferation of biofilm embedded microorganisms on the surface of medical devices. Therefore, the art has sought a biofilm penetrating composition, method for coating medical devices, method for removing biofilm embedded microorganisms from at least one surface of medical devices, or coated medical device, which: provides disruption of the biofilm thereby allowing antimicrobial agents and/or antifungal agents to penetrate the biofilm and remove biofilm embedded microorganisms from the surface of medical devices; and prevents the growth or proliferation of biofilm embedded microorganisms on the surface of medical devices. It is believed that the present invention will achieve these objectives and overcome the disadvantages of other medical devices and techniques in the field of the invention, but its results or effects are still dependent upon the skill and training of the operator.
SUMMARY OF INVENTION
In accordance with the invention the foregoing advantages have been achieved through the present composition for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device comprising at least one biofilm penetrating agent.
A further feature of the composition is that the composition may further comprise a base material. Another feature of the composition is that the at least one biofilm penetrating agent may be selected from the group consisting of cysteine and derivatives thereof. An additional feature of the composition is that the at least one biofilm penetrating agent may be selected from the group consisting of N-acetylcysteine and derivatives thereof. A further feature of the composition is that the base material may be selected from the group consisting of rubbers, thermoplastics, and elastomers. Another feature of the composition is that the base material may be selected from the group consisting of water and buffer solutions.
In accordance with the invention the foregoing advantages have also been achieved through the present composition for removing substantially all of the biofilm embedded microorganisms from at least one surface of a medical device comprising at least one biofilm penetrating agent.
A further feature of the composition is that the composition may further comprise a base material. Another feature of the composition is that the at least one biofilm penetrating agent may be selected from the group consisting of cysteine and derivatives thereof. An additional feature of the composition is that the at least one biofilm penetrating agent may be selected from the group consisting of N-acetylcysteine and derivatives thereof. A further feature of the composition is that the base material may be a buffer solution. Another feature of the composition is that the buffer solution may be phosphate buffered saline.
In accordance with the invention the foregoing advantages have also been achieved through the present method for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device comprising the steps of: providing a medical device having at least one surface; providing a biofilm penetrating composition; and contacting the biofilm penetrating composition to the medical device in an amount sufficient to substantially prevent the growth or proliferation of biofilm embedded microorganisms on the at least one surface of the medical device.
A further feature of the method for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device is that the biofilm penetrating composition may be formed by mixing cysteine or derivatives thereof and a base material. An additional feature of the method for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device is that the biofilm penetrating composition may be contacted to the medical device for a period of time sufficient to form a coating of the biofilm penetrating composition on the at least one surface of the medical device. Another feature of the method for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device is that the biofilm penetrating composition may be contacted to the medical device by integrating the biofilm penetrating composition with the material forming the medical device during formation of the medical device. A further feature of the method for substantially preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of a medical device is that the biofilm penetrating composition may be contacted to the medical device by flushing the medical device in the biofilm penetrating composition for a period of time sufficient for preventing the growth or proliferation of biofilm embedded microorganisms on at least one surface of the medical device.
In accordance with the invention the foregoing advantages also have been achieved through the present coated medical device having at least one surface which may substantially prevent the growth or proliferation of biofilm embedded microorganisms on the at least one surface of the coated medical device, comprising: (a) a medical device; and (b) a biofilm penetrating composition coating for substantially preventing the growth or proliferation of biofilm embedded microorganisms on the at least one surface of the coated medical device, the biofilm penetrating composition coating being disposed upon the at least one surface.
A further feature of the coated medical device is that the biofilm penetrating composition coating may include at least one biofilm penetrating agent. An additional feature of the coated medical device is that the biofilm penetrating composition coating may further include a base A material. Another feature of the coated medical device is that the at least one biofilm penetrating agent may be selected from the group consisting of cysteine and derivatives thereof. A further feature of
Andrews & Kurth L.L.P.
Baylor College of Medicine
Matheny Anthony F.
Soubra Imad
Warden, Sr. Robert J.
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