Chemical apparatus and process disinfecting – deodorizing – preser – Physical type apparatus – Apparatus for treating solid article or material with fluid...
Reexamination Certificate
2001-03-14
2001-11-20
Warden, Sr., Robert J. (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Physical type apparatus
Apparatus for treating solid article or material with fluid...
C422S298000, C422S108000
Reexamination Certificate
active
06319481
ABSTRACT:
BACKGROUND OF THE INVENTION
Acute care providers rely on various types of sterilization equipment in conjunction with established procedures to provide contamination-free perioperative care. Further, there are many regulations regarding sterilization and other aseptic practices that acute care providers must comply with. Compliance with these regulations is time-consuming and expensive, but necessary for providing quality health care. In addition, existing sterilization protocols and aseptic requirements are not universally consistent and can vary within each health care facility.
Consequently, there exists in the art different protocols which correspond to a variety of sterilization equipment and methodology regarding the processing of sterile supplies within an acute care facility. The majority of acute care facilities utilize rigid containers wherein surgical instruments and supplies are placed for sterilization, storage and transport. Depending on the processing requirements, acute care facilities must use a variety of container designs and protocols to sterilize instruments and supplies. Examples of such protocols include, but are not limited to: ETO gas, standard steam and flash autoclaving, as well as alternative low temperature methods of sterilization. All of the preceding protocols are well known within the art.
Depending on the method of sterilization, a specific type of sterilant (steam, ETO, Plasma gas, etc.) is introduced under controlled conditions (usually within a chamber) into the sealed container to eliminate microorganisms within, around and on the contents. After sterilization and prior to use, sealed containers serve as a protective repository for storage and transport of the sterilized contents. The majority of conventional sterilization containers are generally rectangular in shape wherein the lid is normally vented with a patterned group of small holes. Occasionally, the bottom of the container will also have vents aligned to mirror the placement of the vents in the lid. Each vent has a filter that allows the entry and exit of the sterilant during the sterilization cycle. After sterilization, the filters provides a protective bacterial barrier which maintains the sterile integrity of the contents during storage and transport.
However, the arrangements of filtered vents known in the art have certain disadvantages. Where vents are present only on the lid, sterilant must enter and exit through the same pathway(s). This can inhibit the introduction, dispersal and exposure of the sterilant throughout the sealed container. The inadequacy of this vent configuration is particularly deficient to meet flash gravity requirements.
Where vents are present on the bottom of the container as well as the lid, the sterilant enters and exits in a column that is created by the direct alignment of the vents in the lid and bottom. This column effect can create “dead spots” within the sealed container whereby the sterilant does not come into sufficient contact to sterilize all of the contents. Most notably, “dead spots” can occur in the corners and along the walls of the container.
Another disadvantage of conventional sterilization containers is fluid retention associated with standard autoclaving, alternative low temperature and especially flash sterilization methods. As the sterilizing media is introduced into the sealed container, condensation forms and collects on the flat (or level) floor of the container. Consequently, instruments located at (or near) the bottom of the container are at risk of corroding due to prolonged contact with the retained condensate.
If the bottom of the container is vented, the barrier properties of filters can be deficient immediately after the door of the sterilizer is opened. This situation is especially a concern when retained moisture is present and the containers are handled or transported while they are still hot. Following the “cool down” period, containers with vented bottoms are also at risk of contamination when retained moisture comes into prolonged contact with the filter elements.
Because of the substantial concern among perioperative professionals over retained moisture, existing containers are seriously limited and inappropriate for the multiple sterilization methods utilized by acute care facilities. The concern regarding retained moisture in sterilization containers is universally applicable to flash sterilization protocols. Since flash sterilization protocols do not have an adequate drying cycle, retained moisture is a normal condition in both frequency (as in always) and magnitude (as in ample) for each and every flash sterilization cycle. This condition is commonly known within the art as “wet packs.”
SUMMARY OF THE INVENTION
In the present invention, a generally universal sterilization container is provided with vent holes in both the lid and the bottom of the container, but offset so that sterilant flows throughout the container between the time it enters and exits. In addition, the bottom of the container is sloped toward a center area so that all fluids flow away from the filters that cover the vents in the bottom of the container. The unique combination of design features embodied in the multipurpose sterilization container of the present invention offer enhanced performance, as well as providing a consistent protocol for use with a variety of processing methods, including flash gravity sterilization.
Accordingly, it is an object of the present invention to provide an all-purpose sterilization container in which the vent configuration promotes a distribution of sterilant throughout the container and to all items being sterilized.
It is a further object to provide a container having a floor with areas that slope way from the container end walls to a lower collection area where condensed fluids are drawn away from the sloping areas.
Yet another object of the invention is to prevent vent filters from being exposed to standing fluids by disposing the vents that the filters cover in the sloping areas of the container floor.
Still another object of the invention is to prevent items being sterilized from being in contact with standing fluids by supporting them above the fluid collection area of the container floor.
These and other objects, aspects and features of the present invention will be better understood from the following detailed description of the preferred embodiments when read in conjunction with the appended drawing figures.
REFERENCES:
patent: 4617178 (1986-10-01), Nichols
patent: 4783321 (1988-11-01), Spence
patent: 5352416 (1994-10-01), Wagner
Brucker H. Michael
Conley Sean
Warden, Sr. Robert J.
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