PROTECTIVE BARRIER FOR STERILIZATION CONTAINERS

Abstract

The present disclosure provides a cover or sleeve for use with a sterilization container comprising a collapsible enclosure configured to conform to the shape and size of the sterilization container. The collapsible enclosure includes an inner layer configured to withstand a sterilization procedure and a protective layer bonded to the inner layer. The protective layer is configured to protect the inner layer and to withstand the sterilization procedure. The enclosure further comprises a scalable opening for receiving the sterilization container within the interior of the enclosure. The collapsible enclosure is universally adapted for use for a variety of validated sterilization methods, such as steam, hydrogen peroxide, gas plasma, ozone, ethylene oxide and the like and with various sterilization trays, baskets and the like.

Claims

1. A sterilization cover comprising: a collapsible enclosure configured to conform around an outer surface of a sterilization container, the enclosure comprising an inner layer configured to withstand a sterilization procedure and a protective layer bonded to the inner layer and configured to protect the inner layer and to withstand the sterilization procedure; and a sealable opening for receiving the sterilization container within the enclosure.

2. The cover of claim 1, wherein the sterilization procedure includes steam sterilization.

3. The cover of claim 1 wherein the sterilization procedure includes hydrogen peroxide, gas plasma, ozone or ethylene oxide.

4. The cover of claim 1, wherein the sealable opening is movable between an open position, wherein the opening is configured to receive the sterilization container within the collapsible enclosure, and a closed position, wherein the opening is substantially impermeable to liquids and pathogens.

5. The cover of claim 1, wherein the inner layer and the protective layer are configured to withstand a temperature of at least 270 degrees Fahrenheit for at least 60 minutes.

6. The cover of claim 1, wherein the inner layer and the protective layer each comprise a material that is permeable to gases and substantially impermeable to liquids and pathogens.

7. The cover of claim 1, wherein the protective layer comprises a first layer bonded to one side of the inner layer and a second layer bonded to an opposite side of the protective layer.

8. The cover of claim 1, wherein the inner layer comprises a substantially non-absorbable, anti-microbial material.

9. The cover of claim 1, wherein the inner layer comprises a non-woven polypropylene, hydrophobic material.

10. The cover of claim 1, wherein the outer layer comprises a material with substantially high tensile strength.

11. The cover of claim 3, wherein the sealable opening comprises a self-adhesive portion for bonding to the outer layer.

12. The cover of claim 3, wherein the sealable opening comprises a clamp.

13. The cover of claim 11, wherein the clamp further comprises a lock for locking the clamp in the closed position.

14. The cover of claim 3, further comprising a sensor configured to detect a presence of a pathogen within an interior of the enclosure when the sealable opening is in the closed position.

15. The cover of claim 13, further comprising an indicator coupled to the sensor and configured to indicate the presence of the pathogen within the interior.

16. The cover of claim 1, further comprising a handle coupled to the outer layer.

17. The cover of claim 1, further comprising a pressure skid surface on at least one portion of the enclosure.

18. An outer sleeve for use with a sterilization container, comprising: a flexible inner layer configured to conform to an outer surface of the sterilization container and comprising a material that is substantially impermeable to liquids and pathogens and permeable to gases; an outer layer bonded to the inner layer and comprising a material configured to protect the inner layer; and wherein the inner and outer layers define an interior and comprise a sealable opening for receiving the sterilization container within the interior.

19. The outer sleeve of claim 17 wherein the protective layer comprises a material with a high tensile strength, the material being permeable to gases and substantially impermeable to liquids and pathogens.

20. The outer sleeve of claim 17 wherein the sealable opening is movable between an open position, wherein the opening is configured to receive the sterilization container within an interior of the sleeve, and a closed position, wherein the sealable opening is substantially impermeable to liquid and pathogens.

21-29. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIGS. 1A and 1B illustrate a sterilization cover for use with a sterilization container according to the present disclosure;

[0016] FIG. 2 is a side view of the sterilization cover of FIG. 1;

[0017] FIG. 3 is a bottom view of the sterilization cover of FIG. 1;

[0018] FIG. 4 is a perspective view of a clamp for use with the sterilization cover of FIG. 1 in accordance with one embodiment of the present invention; and

[0019] FIG. 5 illustrates a self-adhesive strip for use with the sterilization cover of FIG. 1 in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0020] This description and the accompanying drawings illustrate exemplary embodiments and should not be taken as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

[0021] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0022] Except as otherwise noted, any quantitative values are approximate whether the word “about” or “approximately” or the like are stated or not. The materials, methods, and examples described herein are illustrative only and not intended to be limiting. Any molecular weight or molecular mass values are approximate and are provided only for description.

[0023] The following disclosure is presented with respect to applications for surgical and/or dental instruments or implants. However, the embodiments may be implemented in any application requiring treatment of devices or items, especially for certain heat, steam, radiation, or chemical treatments.

Introduction to the Sterilization System Embodiments

[0024] In general, the embodiments relate to an enclosure component for use with sterilization systems that typically include some form of a container, such as a tray or basket. The component may comprise a flexible outer sleeve or a collapsible enclosure that is universally adapted for use with existing sterilization containers of known medical and/or dental sterilization systems. The embodiments of the enclosure may be designed with materials and components that can withstand any form of sterilization technique. For example, the embodiments may be capable of sterilization using (1) ethylene oxide (EO); (2) chemical soaking; (3) steam sterilization; and (4) plasma sterilization, e.g., employing a hydrogen peroxide (H.sub.2O.sub.2) vapor.

[0025] In some embodiments, the enclosure is designed with materials and components for steam-based sterilization. With steam sterilization, instruments/implants are placed within a sterilization tray and loaded into a sterilization device, such as an autoclave. Using a combination of steam, time, temperature and pressure, the instruments/implants in the autoclave are sterilized.

[0026] In these embodiments, the enclosure of the present invention is capable of withstanding the high temperature and pressures of steam sterilization. Steam sterilization is typically achieved by exposing products to saturated steam at high temperatures (about 250° F. to about 275° F.). The Products are placed in a device called the autoclave and heated through pressurized steam to kill all microorganisms including spores. In particular, the embodiments may be designed to withstand temperatures of at least about 270° Fahrenheit for at least 60 consecutive minutes without compromising the design of the system. Accordingly, in the embodiments, the enclosure of the present invention will have a high heat deflection value, i.e., little deformation and dimensional change due to the extended heating for a high number of cycles.

[0027] Sterilization Container Features

[0028] With regard to the container, which may take the form of a tray, basket or other known vessel for holding instruments for sterilization, the surgical or dental instruments/implants may be held within the sterilization container in spaced relation to each other and within the walls of the container. The container may be formed with a width, length, height, and depth designed to accommodate different types of instruments and implants. In addition, the container may contain a variety of supports, clamping members, forms, mats, pressure skids, and other instrument retaining means. These structures may be shaped in a variety of configurations, such as horizontally, vertically, and compartmentalized. In some embodiments, the container may comprise various holes or slots used as locating tabs for small barriers or walls to allow for internal configurations, e.g., sub-trays within the main tray.

[0029] In some embodiments, the sterilization container may be constructed from metal, such as stainless steel, plastic or other materials suitable for medical device sterilization procedures. Metal sterilization containers may be used in the embodiments, for example, if it is desired for the tray to retain its shapes during high temperature steam sterilization. Alternatively, in some embodiments, the container may be constructed from a plastic, such as Radel® 5000. Plastic containers may be used in the embodiments when it is desired to provide a pliable structure that will not damage sensitive instruments or implants, as may occur when using metal containers.

[0030] Adaptive Enclosure—a Tray “Skin”

[0031] With regard to the outer sleeve or collapsible enclosure, in some embodiments, the enclosure is provided as a thermoplastic wrap or skin that is sized/shaped to conform to the sterilization container (hereinafter a “tray skin”). In other words, in some embodiments, the enclosure is a protective barrier and acts as a “skin” that can conform and adapt to the size and shape of the container. Of course, while described as a “tray skin” it is understood that such term does not limit the outer sleeve to use with trays only, as the outer sleeve can be used with all types of sterilization containers including baskets and other similar holding structures. Further, the container may or may not have a lid or cover.

[0032] In some embodiments, the tray skin design is tailored to fit the need of a surgical or dental medical facility, as well as other validated uses with similar requirements for sterile packaging. In particular, the tray skin serves as a flexible particulate and fluid barrier designed to maintain sterility, especially during and following a steam exposure cycle and/or other similarly validated sterile procedures. Accordingly, the tray skin allows surgical related medical facilities utilizing steam sterilization technology or similarly validated sterilization methods to be able to sterilize their instruments, implants, or other similar validated items in any sterile packaging, container, or similar enclosure they prefer.

[0033] The tray skin of the present invention reduces or eliminates drying and cool-down times and obviates the need for equalizing the tray. This can potentially save the medical facility anywhere from 1.5 to 3 hours in down-time, thereby providing more capacity for emergent or unplanned procedures. In addition, the tray skin eliminates “wet loads” because the only moisture that remains in the sterilization container is “sterile condensation” caused by condensation on surface of the metal components (i.e., outside moisture is not present within the interior of the tray skin) when the sterilizer is opened from 270° to room temperature due to reducing or eliminating the need for a dry and cool down cycle. (i.e., the entire inside and outside of the sterilization container is within the sterile field). The tray skin by design is a particulate and fluid barrier when in the closed position protecting anything inside of the tray skin from outside foreign contaminants under approved regulatory sterilization parameters. In certain embodiments, the tray skin is designed as a disposable, one-time use item that can be thrown away after use.

[0034] Referring now to FIGS. 1A and 1B, an outer sleeve or cover 10 according to one embodiment of the present invention includes a collapsible enclosure 20 for housing a representative sterilization container 25 within an interior 30 of enclosure, and a sealable opening 35 for moving the sterilization container into and out of interior 30. Collapsible enclosure 20 is flexible and designed to conform to multiple sizes to fit around a variety of different containers. In preferred embodiments, enclosure 20 has an open or enlarged size of about 10 inches to 20 inches in width and about 10 inches to 30 inches in length, although it should be recognized that enclosure is not limited to these sizes. In an exemplary embodiment, enclosure 20 resembles a lightweight square or rectangular shaped duffle bag or collapsible suitcase, although other configurations can be used in accordance with the present invention.

[0035] In certain embodiments (shown in FIGS. 2 and 3), enclosure 20 further includes one or more handles 50 and webbing supports 60 to compliment the tray structure, depending on their intended use. Handles 50 and weight supports 60 may be connected together and secured to enclosure 20. In some embodiments, these structures are made of a durable non-absorbent webbing material, such as a thermoplastic or firm elastomer, designed to provide support for the weight of items placed inside of the tray.

[0036] In an exemplary embodiment, handles 50 are circularly shaped like a narrow racetrack with two elongate portions 52 extending along the bottom and midway up the sides of enclosure 20 (see FIG. 2). Handles 50 and weight supports 60 may be thermally bonded to enclosure 20 and are preferably designed to withstand temperatures of at least 270 degrees Fahrenheit for a minimum of 60 consecutive minutes.

[0037] Of course, it should be understood that enclosure 20 may include features other than handles for carrying sleeve, such as a strap, sling, belt, cord, buckle, band, tie, wheels (i.e., for a rolling bag) or the like. Alternatively, enclosure 20 may include a single handle, or more than 2 handles. In addition, enclosure 20 may include other features, aside from webbing supports 60 to provide support for enclosure 20, such as additional protective layers at selected locations around enclosure 20.

[0038] Referring now to FIG. 2, enclosure 20 is a tray skin that comprises a sealable skin/outer sleeve having a multi-layer structure comprising one or more middle layers 70 and one or more protective layers 80, 82. In an exemplary embodiment, the one or more middle layers 70 of the tray skin are made from a non-woven polypropylene, non-absorbable hydrophobic spun lace anti-microbial material. Of course, it will be recognized that a variety of other suitable thermoplastic or thermoset polymers that meet the requirements of the present invention may be used for middle layer 70.

[0039] In certain embodiments, middle layer 70 may be designed with a hydrostatic head with specified and engineered PSI creating anti-wicking properties that form both a particulate/pathogen barrier and a liquid barrier. In addition, middle layer 70 still allows steam and other validated sterilization methods to pass through the material to sterilize its contents. Thus, middle layer 70 is permeable to certain gases, such as steam, while being substantially impermeable to liquids, pathogens and other particulates. Accordingly, middle layer 70 of the tray skin creates a barrier that protects the items in the enclosure from outside moisture, contaminates, and/or pathogens that could affect the sterility of the contents held within the tray. As noted above, middle layer 70 of enclosure 20 is designed to withstand a minimum of 270 degrees Fahrenheit for a minimum of 60 consecutive minutes.

[0040] Protective layers 80, 82 preferably comprise an outer layer 80 and an inner layer 82 configured to protect and substantially surround middle layer 70. Protective layers 80, 82 are made of a strong, breathable, hydrophobic material with a tensile strength designed to withstand the high temperature and pressure environments found in sterile processing applications, such as an autoclave. In an exemplary embodiment, protective layers 80, 82 comprise a canvas-like material made of cotton, linen, hemp or the like, although it will be appreciated that other suitable materials may be used, such as denim, vinyl or the like, In one embodiment, protective layers 80, 82 are spot-bonded to middle layer 70 with a medically safe bonding material. This bonding allows the layers to be secured to each other without affecting the integrity and functionality of its design. Protective layers 80, 82 are designed to withstand temperatures of at least 270 degrees Fahrenheit for at least 60 consecutive minutes. Protective layers 80, 82 preferably cover substantially the entire portion of each side of middle layer 70. However, it will be understood that other configurations are possible. For example, protective layers 80, 82 may cover only certain portions of middle layer 70, i.e., a sufficient amount of coverage to protect the middle layer 70.

[0041] As shown in FIG. 3, enclosure 20 may include pressure skids 90 to provide a structure to bear the weight of an instrument or implant. Accordingly, pressure skids 90 are designed with various shapes and sizes to absorb the pressure of heavy objects, and distribute the pressure away from the layers of the tray skin. In one embodiment, pressure skids 90 are made with a medically-safe, hardened polymer material, such as an elastomer/rubber, or similar approved material that penetrates and hardens through the tray skin and serves to redirect pressure.

[0042] Referring now to FIGS. 4 and 5, enclosure 20 includes a sealable opening for allowing the sterilization container to be moved into and out of enclosure 20. In the representative embodiment, the sealable opening is a substantially rectangular-shaped fold seal on the side of enclosure 20, although other configurations may be used (e.g., triangular-shaped, oval, circular, etc.).

[0043] In one embodiment (shown in FIG. 4), enclosure 20 comprises a seal clip 100 made from a durable medically safe polymer or other suitable material. Seal clip 100 preferably comprises upper and lower clamps 102, 104 pivotally coupled to each other with a hinge 106. Upper clamp 102 includes a pair of outer locking barrels 108, 110 and lower clamp 104 includes a central locking barrel 112. Outer locking barrels 108, 110 can be secured to central locking barrel 112 to lock clamps 102, 104 into position and secure clip 100. A handle 120 may be formed on the upper or lower clamp to facilitate moving clamps 102, 104 into the closed position.

[0044] Clamps 102, 104 preferably have a length of about 10 to 30 inches, although the specific size will depend on the size of the sterilization containers housed within enclosure 100. In one embodiment, upper clamp 102 is generally triangular-shaped and provides a press-fit slide and secure click over lower clamp 104. As shown, there is an overlapping keyhole design on the secured end of enclosure 20 to secure and seal clip 100, which extends past enclosure 20 to provide for a pre-engineered tamper proof lock, thereby ensuring that the enclosure 20 has remained secure from the time it was sealed until the time the enclosed items are needed for use.

[0045] In another embodiment (shown in FIG. 5), enclosure 20 comprises an outer portion 130 that may be folded relative to the rest of enclosure 20. Outer portion 130 may include one or more pre-marked fold guides 132 for ease of use. Enclosure 20 further comprises a self-adhesive strip 134 designed to adhere to outer layer 80 of enclosure 130. Self-adhesive strip 134 may comprise any suitable material, such as epoxy, acrylic, rubber, silicone, polyurethane or the like. In use, the operator folds outer portion 130 over enclosure 20 and seals enclosure 20 by firmly pressing along adhesive strip 134 to provide even coverage to seal.

[0046] In certain embodiments, enclosure 20 further includes a sensor (not shown) for detecting pathogens, liquids or other particulate matter within the interior of enclosure. Suitable sensors for use with the present invention may include PCT and microarray based sensors, optical sensors (e.g., biolouminescence and fluorescence), piezoelectric, potentiometric, amperometric, conductometric, nanosensors or the like. Enclosure 20 further includes an indicator, such as a display on the outer surface of enclosure 20 (not shown), coupled to the sensor and configured to indicator the presence of pathogens, liquids or other particulars detected by the sensor. The indicator may be any suitable chemical indicator validated for sterilization procedures that undergoes a physical or chemical change visible to the human eye after exposure to certain parameters. The indicator and sensor may be part of the same device, or separate from each other. The sensor is preferably designed to detect pathogens after clip 100 has been sealed and moved into a closed position to ensure that enclosure 20 has remained secure from the time it was sealed until the time the enclosed instruments or other items are needed for use.

[0047] In use, enclosure 20 is place around a sterilization container, such as the container 25 shown in FIG. 1. The container 25 can be advanced into enclosure 20 until it is completely enclosed within the interior 30 of cover 10. Sealable opening 35 extends beyond container 25, as shown in FIG. 1. Sealable opening 35 includes one or more fold lines or guides 132 to facilitate the operator's closing of sealable opening 35 over the end of container 25 such that container 25 is completed enclosed within cover 10. Sealable opening 35 is then closed and sealed, either with seal clip 100, self-adhesive strip 134 or other suitable means. Once container 25 is secured within cover 10, a tamper-proof sterilization chemical lock (such as the chemical indicator described above) is engaged to ensure that the interior of cover remains sterile until it is ready for use.

[0048] While the invention has been described in detail herein in accordance with certain preferred embodiments thereof, many modifications and changes therein may be effected by those skilled in the art. Accordingly, the foregoing disclosure should not be construed to be limited thereby but should be construed to include such aforementioned obvious variations and be limited only by the spirit and scope of the following claims.