Apparatus and method for indicating biological content within a container

An apparatus for indicating biological content within a container is provided. The apparatus includes a medical sterilization container having a cover removably attached to the medical sterilization container. An enclosable, sterilizable interior compartment is formed by the medical sterilization container and the cover, wherein the interior compartment is sized to house at least one medical instrument. A biological indicator is located at least partially in communication with the interior compartment, wherein the biological indicator provides at least one indication of biological content within the interior compartment after the medical sterilization container and cover are subjected to a sterilization process.

FIELD OF THE DISCLOSURE

The present disclosure is generally related to a medical sterilization container and more particularly is related to an apparatus and method for indicating biological content within a container.

BACKGROUND OF THE DISCLOSURE

Articles such as medical instruments and the like are usually sterilized in a sterilization machine, such as an autoclave, in which the articles are exposed to high-pressure saturated steam for a relatively brief interval. Unless the articles are to be used immediately and in close proximity to the autoclave, it is desirable to sterilize the articles while they are inside a sterilization container. Once the sterilization process is complete, the medical instruments may be housed within the sterilization container until they are used for a medical procedure. To ensure a safe medical environment, medical staff must ensure that the medical instruments are fully sterilized and that the sterilization container hasn't become contaminated since the sterilization process. However, it is difficult if not impossible to tell when a sterilized container has subsequently been opened, thereby rendering any medical instruments inside contaminated and unfit for a medical procedure.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure provide an apparatus and method for indicating biological content within a container. Briefly described, in architecture, one embodiment of the apparatus, among others, can be implemented as follows. The apparatus includes a medical sterilization container having a cover removably attached to the medical sterilization container. An enclosable, sterilizable interior compartment is formed by the medical sterilization and the cover. The interior compartment is sized to house at least one medical instrument. A biological indicator located at least partially in communication with the interior compartment, wherein the biological indicator provides at least one indication of biological content within the medical sterilization container after the medical sterilization container and cover are subjected to a sterilization process.

The present disclosure can also be viewed as providing methods for indicating biological content within a container. In this regard, one embodiment of such a method, among others, can be broadly summarized by the following steps: subjecting a medical sterilization container having a cover removably attached to the medical sterilization container to a sterilization process, wherein the medical sterilization container has an enclosable, sterilizable interior compartment formed by the medical sterilization container and the cover, wherein the interior compartment is sized to house at least one medical instrument; and indicating with the biological indicator located at least partially in communication with the interior compartment a presence of a biological content within the interior compartment after a completion of the sterilization process.

DETAILED DESCRIPTION

FIG. 1is a cross-sectional illustration of an apparatus for indicating biological content within a container10, in accordance with a first exemplary embodiment of the present disclosure. The apparatus for indicating biological content within a container10, which may be referred to simply as ‘apparatus10’ includes a medical sterilization container20having a cover30that is removably attached to the medical sterilization container20. An enclosable, sterilizable interior compartment40is formed by the medical sterilization container20and the cover30. The interior compartment40is sized to house at least one medical instrument50. A biological indicator60is located at least partially in communication with the interior compartment40. The biological indicator60provides at least one indication of biological content within the interior compartment40after the medical sterilization container20and cover30are subjected to a sterilization process.

The medical sterilization container20may include any container that has an enclosable interior compartment40, which is usually provided through the use of the cover30. However, the medical sterilization container20may be capable of having an enclosed interior compartment40without the use of a cover30, or similar structure. The medical sterilization container20is sized and designed to be used in a sterilization environment, such as by inserting the medical sterilization container20into an external autoclave, or other sterilizing device. While in the autoclave, the medical sterilization container20may be subjected to heat, pressure, chemicals, or other means of sterilization. The medical sterilization container20may also function with a sterilization medium that is placed within an interior compartment of the medical sterilization container20. The interior compartment may include the interior compartment40of the medical sterilization container20, or it may include another portion of the medical sterilization container20.

The interior compartment40may be characterized as the area of the medical sterilization container20that is interior of the walls of the medical sterilization container20and the cover30, when the cover30is affixed to the medical sterilization container20. As is shown inFIG. 1, the interior compartment40may be sized to hole a tray22for supporting the quantity of medical instruments50, or any portion thereof, while inside the medical sterilization container20. The interior compartment40may be sized to allow for sufficient space around a tray22, thereby allowing for sterilization material to contact various portions of the tray22. For example, the tray22may include perforations for allowing sterilization material to pass through, and it may have a plurality of holding devices, such as flexible protrusions, formed shapes, or other holders that can receive a medical instrument50. The holding devices may be capable of substantially securing the medical instrument50before, during, and after a sterilization process, while at the same time, providing enough space proximate to the medical instrument50to allow for proper sterilization. Of course, the medical sterilization container20may be capable of holding a quantity of medical instruments50during a sterilization process and retaining the sterilized environment within the interior compartment40after the sterilization process is completed without the use of a tray22or similar structure.

Any number of biological indicators60may be used with a single apparatus10, but it may be preferable to use only one biological indicator60with each apparatus10to lessen the costs associated with the biological indicators60. The biological indicator60may be positioned in communication with the interior compartment40of the medical sterilization container20. This may include any position where the biological indicator60, or a component or portion of the biological indicator60, is in contact with the interior compartment40of medical sterilization container20. This positioning of the biological indicator60allows for proper sensing and/or indicating a biological content within the interior compartment40. The biological indicator60may be positioned within any type of structure, such as a mesh basket, perforated container, holding device, adhesively-bonded device, or any combination thereof.

As one having skill in the art can see, many variations on the exact location of the biological indicator60exists. For example, the biological indicator60may be fully located within the interior compartment40, partially located within the interior compartment40, positioned within the cover30, within a side wall of the medical sterilization container20, and any combination thereof. As is shown inFIG. 1, the biological indicator60is positioned fully within the medical sterilization container20, proximately below the cover30. The biological indicator60may also be positioned such that it may be removed from its positioned in communication with the interior compartment40without opening the cover30, and therefore, without subjecting the interior compartment40to contamination or unsterile conditions. Other variations may include an electronic-based biological indicator60, such as an electronic sterility indicator, that has a transmitter positioned within the interior compartment40and a receiver positioned exterior of the medical sterilization container20(the receiver is not shown inFIG. 1).

FIG. 2is a top view illustration of the apparatus for indicating biological content within a container ofFIG. 1, in accordance with the first exemplary embodiment of the present disclosure. In particular,FIG. 2illustrates a top view of the cover30of the medical sterilization container20that depicts a materially translucent portion32within the cover30. The materially translucent portion32may allow a user of the apparatus10to view an object within the interior compartment40of the medical sterilization container20while the cover30is positioned on the medical sterilization container20. Accordingly, the materially translucent portion32may be positioned within the cover30, within the medical sterilization container20, or within another component of the apparatus10. For example, the materially translucent portion32may allow a user of the medical sterilization container20to view a biological indicator60within the interior compartment40after the medical sterilization container20has been subjected to a sterilization process. This permits the user to identify the biological content within the interior compartment40without having to remove the cover30or otherwise subject the medical instruments50within the medical sterilization container20to an unsterile environment.

The materially translucent portion32may be constructed from any material that provides a substantially non-opaque viewing window through the cover30. For example, the materially translucent portion32may include a material that is substantially or fully translucent, transparent, and/or clear, thereby allowing enough light to traverse through the materially translucent portion32for a user external to the apparatus10to see through the materially translucent portion32. Any degree of viewing through the materially translucent portion32is considered within the scope of the present disclosure. Commonly, the materially translucent portion32may be integrally constructed with the cover30, or otherwise connected to the cover30to allow for a substantially unitary construction. Of course, the materially translucent portion32may be designed to be openable, removable, replaceable, or otherwise capable of being manipulated or altered, depending on the design of the apparatus10.

The biological indicator60may include any type of indicator device that is capable of indicating any biological content within the interior compartment40. This may include sophisticated electronic devices, simple chemical-based devices, or a variety of other devices, or any combination thereof. For example, the biological indicator60may include indicator strip, such as the 3M® Attest® biological indicator, or any other type of indicator strip. The indicator strip may be positioned fully within the interior compartment40but may be viewable from outside of the medical sterilization container20by the materially translucent portion32in the medical sterilization container20or the cover30.

The biological indicator60may also include an indicator label, such as a temperature indicating label like the Tempilable® label sold by the Tempil Corporation. This temperature indicating label may be positioned fully within the interior compartment40and may be viewable from outside of the medical sterilization container20by the materially translucent portion32in the medical sterilization container20or the cover30. The temperature indicator label may indicate when a specific temperature is reached within the interior compartment40during a sterilization process. The specific temperature may be one, which eliminates all biological content from within the interior compartment40. Accordingly, when the sterilization process is completed, the temperature indicator strip may indicate that the temperature has been reached and the interior compartment is sterile.

FIG. 3is a cross-sectional illustration of an apparatus for indicating biological content within a container110, in accordance with a second exemplary embodiment of the present disclosure. The apparatus for indicating biological content within a container110of the second exemplary embodiment, which may be referred to herein as ‘apparatus110’ may be substantially similar to the apparatus10of the first exemplary embodiment, and include any of the features, designs and/or configurations that are described with respect to the first exemplary embodiment. As is illustrated, the apparatus110includes a medical sterilization container120having a cover130that is removably attached to the medical sterilization container120. An enclosable, sterilizable interior compartment140is formed by the medical sterilization container120and the cover130. The interior compartment140is sized to house at least one medical instrument150. As is shown, the at least one medical instrument150may be positioned on a tray122within the medical sterilization container120.

In the second exemplary embodiment, the biological indicator160is depicted as being located within the cover130; however, the biological indicator160may alternatively be located within a wall of the medical sterilization container120, or another structure of the apparatus110. Specifically, the biological indicator160is disclosed as including a pressure indicator having a flexible membrane, provides at least one indication of biological content within the interior compartment140after the medical sterilization container120and cover130are subjected to a sterilization process. The flexible membrane may be a component of a valve, or another structure of the apparatus110. For example, a flexible membrane within the valve may be designed to indicate a specific temperature, pressure, or another characteristic indicative of a biological content within the medical sterilization container120. This may include the use of a pressure-actuated valve having a shape-memory alloy (SMA) material or similar material that changes based on a temperature. InFIG. 3, the biological indicator160is illustrated as being integral with a SMA valve170within the cover130. However, any number of secondary valves172may be included with the apparatus110, wherein the biological indicator160is integral therewith.

In one of many alternatives, the flexible membrane of the biological indicator160may be an independent structure capable of indicating a specific temperature, pressure, or another characteristic indicative of a biological content within the medical sterilization container120. The biological indicator160may be positioned within the cover130between the interior compartment140and exterior atmosphere. As the medical sterilization container120is subjected to a sterilization process, the pressure within the interior compartment140builds up. This pressure increase may deform the flexible membrane of the biological indicator160thereby altering its shape. The flexible membrane may be positioned proximate to a colored membrane that has at least one color. When the flexible membrane contacts the colored membrane, a second color may be formed from the contacting of the colored membrane by the flexible membrane. This second color may indicate that a pressure change has occurred within the interior compartment140, which is an indication of a successful sterilization process.

FIG. 4is a cross-sectional illustration of an apparatus for indicating biological content within a container210, in accordance with a third exemplary embodiment of the present disclosure. The apparatus for indicating biological content within a container210of the third exemplary embodiment, which may be referred to herein simply as ‘apparatus210’ may be substantially similar to the apparatus10and the apparatus110of the first and second exemplary embodiments, respectively, and include any of the features, designs and/or configurations that are described with respect to the first or second exemplary embodiments. As is illustrated, the apparatus210includes a medical sterilization container220having a cover230that is removably attached to the medical sterilization container220. An enclosable, sterilizable interior compartment240is formed by the medical sterilization container220and the cover230. The interior compartment240is sized to house at least one medical instrument250, which may be positioned on or supported by a tray222.

As is shown inFIG. 4, the biological indicator260may be located within the interior compartment240and provide an indication of a biological content within the interior compartment240. The biological indicator260may include an electronic sterility indicator, or another type of electronic biological content indicator, which may include a transmitter262positioned within the interior compartment240and a receiver264positioned exterior of the medical sterilization container220. One or more signals266may be transmitted between the transmitter262and the receiver264. Thus, as can be seen, the biological indicator260may be located within and external to the medical sterilization container220. The transmitter262may be positioned on any portion of the interior compartment240, such as on a medical instrument tray222, on another surface, affixed to or integral with the medical sterilization container220and/or the cover230, or any combination thereof.

Accordingly, the electronic-based biological indicator260may sense a biological content within the interior compartment240and record data associated with the sensed biological content. The data may correspond to a monitored biological content, the sterilization process and a characteristic associated with the sterilization process, such as a sterilization temperature, a sterilization process duration time, a sterilization material, or any other relevant characteristic of the sterilization process. The data may be communicated between the transmitter262and receiver264, and to any additional device, such as a computer or display screen (not shown). Any of the data collected by the electronic-based biological indicator260may be recorded, stored, filtered, or otherwise manipulated. For example, the biological indicator260may also record a log history of the sterilization of the medical sterilization container220.

In addition to monitoring the biological content of the interior compartment240, the biological indicator260may also provide data relating to its own functioning. This may include data indicating a battery life, the status of any computerized components including successful and unsuccessful processes and/or a signal status. The biological indicator260may include a plurality of lights268, such as LED lights, on either the transmitter262and/or receiver264. A green light, for example, may indicate a successful sterilization process and a red light indicates an unsuccessful sterilization process, or a non-sterile environment within the interior compartment240. Furthermore, the biological indicator260may emit one or more signals270to a computerized device280to relay any monitored biological content outside of the apparatus210. The biological indicator260may be designed to last for any number of uses, such as100cycles or more and may provide a time-lapse indication for any length of time, such as a few days or more.

FIG. 5is a cross-sectional illustration of an apparatus for indicating biological content within a container310, in accordance with a fourth exemplary embodiment of the present disclosure. The apparatus for indicating biological content within a container310of the fourth exemplary embodiment, which may be referred to herein simply as ‘apparatus310’ may be substantially similar to apparatus10,110, and210of the first, second, and third exemplary embodiments, respectively, and include any of the features, designs and/or configurations that are described with respect to the first or second exemplary embodiments. As is illustrated, the apparatus310includes a medical sterilization container320having a cover330that is removably attached to the medical sterilization container320. An enclosable, sterilizable interior compartment340is formed by the medical sterilization container320and the cover330. The interior compartment340is sized to house at least one medical instrument350, which may be positioned on or supported by a tray322.

The apparatus310also includes an angled mounting portion390within the cover330. The angled mounting portion390may be positioned on the cover330to contact the biological indicator360, such as when the biological indicator360is formed within the angled mounting portion390. For example, inFIG. 5, the biological indicator360is illustrated as a pressure indicator embedded within the angled mounting portion390, where the pressure indicator changes shapes based on a temperature within the interior compartment340. The angled mounting portion390may be sized to drain a quantity of condensate away from the biological indicator360. This may be necessary in sterilization conditions with substantially moist atmospheres, such as in autoclaves using heater water or other heated fluids to sterilize the medical instruments350. During the sterilization process, the moisture from the sterilization materials may build up on the cover330and condense over the biological indicator360. The angled mounting portion390may provide an angled surface within the cover330that allows any condensate to drain away from the biological indicator360and any other components positioned on the cover330.

As is shown by block402, a medical sterilization container having a cover removably attached to the medical sterilization container is subjected to a sterilization process, wherein the medical sterilization container has an enclosable, sterilizable interior compartment formed by the medical sterilization container and the cover, wherein the interior compartment is sized to house at least one medical instrument. A biological indicator located at least partially in communication with the interior compartment indicates a presence of a biological content within the interior compartment after a completion of the sterilization process (block404).

Of course, the method may include a number of additional steps and variations, including any of the steps, processes, or functions described with respect toFIGS. 1-5. For example, the biological indicator may be positioned fully and/or partially within the interior compartment, and/or in a location viewable from a position external to the interior compartment when the cover is attached to the medical container. The biological indicator may indicate the presence of a biological content by a change in temperature while the biological indicator is viewable from a position external to the interior compartment when the cover is attached to the medical container. For example, the biological indicator may indicate the presence of a biological content with a pressure indicator positioned within at least one of the cover and a wall of the medical sterilization container between the interior compartment and an exterior atmosphere, wherein the pressure indicator deforms shape during a pressure change within the interior compartment. When this occurs, a colored membrane having a first color may be contacted to the pressure indicator to produce a second color.

The biological indicator may also include an electronic-base indicator, such as an electronic sterility indicator at least partially located within the interior compartment. Accordingly, the electronic sterility indicator may indicator the presence of a biological content by monitoring the biological content within the interior compartment and recording a quantity data corresponding to at least one of the monitored biological content, the sterilization process, and a characteristic associated with the sterilization process. The recorded quantity of data may be communicated to the at least one monitored biological content to a receiver. Any number of additional steps, including those not explicitly discussed herein, may be included with the method.