Abstract:
Disclosed is a resposable container usable for storage, transport, disposal and sterilization of contents. The container generally provides an area defined by a series of side panels, a floor panel and a top panel. At least one selectively openable exhaust vent, placed in the generally lower portion of one or more of the panels, allows sterilant, injected into the container from a generally higher point, to exhaust the contaminated or non-sterile gases. A laminate selected for functional compatibility with the user preferred sterilization method covers at least one of the sides of one of the panels of the container.

Description:
FIELD OF THE INVENTION  
         [0001]    The field of the present invention relates generally to a resposable (reusable and disposable) container used for wrapped and unwrapped product sterilization, aseptic sterile product storage, transport, shelf-life protection, decontamination and disposal of bio-hazardous materials.  
         BACKGROUND ART  
         [0002]    Often surgical instruments and materials (hereafter the use of the term “instruments” or “materials” will have interchangeable meaning) used in hospitals, medical clinics, research and medical laboratories, sterilization centers, medical, dental and veterinarian offices and the like are sterilized and used outside of the room where such instruments and materials are sterilized. The path from the sterilization location is almost always non-sterile. Once instruments and/or materials are sterilized, they must be protected from exposure to airborne and handling contamination from the sterilizer to the point of use. Items that are wrapped for post-sterilization protection from airborne and handling contamination, have a limited time and event related shelf life beyond which they are considered unsafe for use. Sterile products may be sent to many various locations and environments for possible emergency use or for routine standby, in the event of need. If not utilized, these products are usually returned to a sterile supply room for future use. Inadvertent contamination of sterile items can take place through airborne particles, dropping, spilling of procedural solutions, crushing or tearing of wrapping materials or penetration with sharp objects. Although many precautions may be implemented to minimize the exposure to contaminants, it is difficult to maintain a germ free environment. Wrapping materials alone do not provide adequate contamination protection against inadvertent contamination and contaminated instruments and/or materials must undergo a sterilization reprocessing or disposal.  
           [0003]    After use, soiled instruments or materials are often placed back into the same containers that were used to store and transport them in sterilized form. Some of these containers carry their contents to a cleaning facility where the container, instruments and reusable materials go through decontamination, cleaning process and sterilization. Others transport bio-hazardous materials such as knife blades, suture and hypodermic needles as well as other contaminates to designated bio-hazardous disposals where they are discarded. This cycle is repeated for the life of the reusable container, instruments and other materials.  
         SUMMARY OF THE INVENTION  
         [0004]    The device of the present invention is an aseptic, resposable sterilization and transport container that overcomes the shortcomings of the prior art. In one embodiment it is enclosable and it provides a user convertible aseptic transport of sterilized materials to a procedure. The same device as a safety product, can also be utilized to isolate used sharps such as needles and knife blades and to collect contaminated materials. The contaminated biomaterials may thereafter be discarded along with the container. Yet in another mode, when not contaminated with bio-waste items, the device, with its laminated or otherwise non-porous construction may be reused as a sterilization container.  
           [0005]    The resposable container of the present invention may be constructed of metalized fiberboard, or laminated metalized cardboard or plastics adhered together with means known in the art such as adhesive, radio frequency welds, rivets or fasteners. The non-metalized version may be constructed of non-porous chemically and heat resistant materials such as plastics as an example. In one embodiment, it is constructed in a form of a box having a lid, into which materials are placed for sterilization, storage and transport. Its laminations are consistent with the anticipated form of sterilization method desirable for its contents. The container of the present invention is initially shipped and stored flat to conserve space. When needed, the container is constructed. When its service is completed, it is discarded.  
           [0006]    In one form, the container of the present invention may serve as a sterilization unit. When sterilized with a sterilization agent (sterilant), such as steam or a high temperature sterilization agent as an example, the exhaust vent, which is preferably placed toward the bottom of one of the panels of the container, is selectively enabled providing an exhaust path for the sterilization agent. This allows a faster sterilization of the contents. The method for flash sterilization is described further in Applicant&#39;s U.S. Pat. No. 4,663,122, which is fully incorporated herein by reference.  
           [0007]    Further, the device of the present invention may be used with a number of sterilization methods and apparatus. For example, the device of the present invention may be applied and used with sterilization systems and processes such as microwave, steam-microwave, electron beam irradiation (e-beam), ultraviolet (UV) light, dry heat, convection heat, convection steam, gamma irradiation, hydrogen peroxide, ethylene oxide, ozone, steam (high speed gravity displacement) unwrapped method, steam gravity displacement unwrapped and wrapped methods, steam pulse-vacuum wrapped or unwrapped, steam pre-vacuum wrapped or unwrapped, paracetic acid, chlorine dioxide, gas plasma, formaldehyde-low temperature steam, microwave—bactericide, xenon lamp (broad spectrum pulsed-light), glass bead, vacuum ovens, heat conduction ovens, forced air ovens, solvent venting ovens, anprolene gas. Depending on the system, the panels of the present invention are coated, sandwiched, covered, lined, laminated or constructed with available laminates or materials suitable or compatible with the desired sterilization system and/or process.  
           [0008]    In one embodiment, the device of the present invention is constructed in a form of a container having a top through which materials are placed for sterilization, storage, transport and/or disposal. Its construction, inner lining or laminate is consistent with the anticipated form of sterilization desirable for its contents. Depending on the sterilization process, the outer skin and the construction material of the container may be similarly coated, covered, lined, laminated or constructed. The container of the present invention is initially shipped and stored flat to conserve space. When needed, the container is constructed. When its service is completed, it is discarded.  
           [0009]    Other aspects, advantages and novel features of the present invention will become apparent from the following Detailed Description, when considered in conjunction with the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 is an elevated view of one of the embodiments of the present invention.  
         [0011]    [0011]FIG. 2 is a cutaway view of one of the panels of the present invention.  
         [0012]    [0012]FIG. 3 is an elevated view of a rack for support of contents in the present invention.  
         [0013]    [0013]FIG. 4 is an elevated view of a sterilization appliance together with the device of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0014]    An elevated view of the device  101  of the present invention is shown in FIG. 1. In its rectangular embodiment, device  101  consists of a bottom panel  103  having marginal edges  115 ,  117 ,  119  and  121 . Connected to marginal edges  115 ,  117 ,  119  and  121  of panel  103  are side panels  105 ,  107 ,  109  and  111  along their respective marginal edges. As shown in FIG. 1, panels  105 ,  107 ,  109  and  111  are further connected to each other along their respective marginal edges  123 ,  125 ,  127  and  129 . In one embodiment, a top panel  113  is movably or hingedly attached to the marginal edge  141  of side panel  111  along its marginal edge  139 . Top panel  113  is connected to its respective side panels  159 ,  161  and  163 . In another embodiment of the present invention (not illustrated), top panel  113  with or without one or more of its respective side panels  159 ,  161  and  163  is removable from container  101  and further comprises a panel placeable on the top of and/or covering side panels  103 ,  105 ,  107 ,  109  and  111 . Although described in its rectangular embodiment, device  101  may be of any shape including, without limitation, square, oblong, rectangular, ovoid, or round and its dimensions may be variable and several.  
         [0015]    In the embodiment of the invention where device  101  is used as a sterilization container, it is useful to employ at least one exhaust vent  143  in one or more side panels  105 ,  107 ,  109  and/or  111 . In this embodiment it may be desirable to remove the contaminated or non-sterile atmosphere in the container  101  by injecting a sterilizing agent/sterilant such as high temperature gas, steam, chemical or other sterilizing agents, as examples, into container  101  through its top portion. Exhaust vent  143  facilitates flow of sterilizing agent(s) through container  101 , over the instruments or materials that are supported by a rack  355  (illustrated in FIG. 3). Since device  101  is multifunctional and it may not be desirable to have an exhaust vent open for applications such as transport or biohazard transport, exhaust vent  143  is defined by a series of perforations or scores  145  (which terms are used interchangeably). When it is desirable to employ exhaust vent  143 , the user can readily enable exhaust vent  143  by separating the panel material along the perforations or scores  145 . In the embodiment shown in FIG. 1, perforations or scores  145  allow the user to remove the material partially or fully from device  101 . The scored or perforated sides designating and facilitating one or more vents  143  may vary in size, shape and configuration. They may be of any shape including, without limitation, square, rectangular, round, oblong, or ovoid and they may be variably located on one or more panels of device  101 . In other embodiments perforations  145  can define a number of shapes and functions known in the art including, without limitation, a continuous or non-continuous loop allowing the user to selectively open and close vent(s)  143  without fully removing it/them. In other embodiments of the invention (not illustrated) exhaust vent(s)  143  maybe achieved by cutting out an opening or having a selective opening such as a door or a subpanel. Yet in other embodiments, exhaust vent  143  may be enabled by peeling away or separating a cover element removably placed over an opening.  
         [0016]    As illustrated in FIG. 4, in sterilization appliances  467  using a gaseous or heat sterilant  469 , device  101  with its top panel  113  in the open position, is placed inside appliance  467 . Sterilant  469  is then applied inside appliance  467  through an entry  473  descending over the instruments and/or materials placed on rack  355 . For best and most expedient results, the aggregate area defined by one or more vents  143  should equal or be greater than the area of exhaust  471  of appliance or sterilizer  467 . This eliminates cold spots from forming in device  101 , which prevent or retard the sterilization of the materials. Generally, device  101  is placed with exhaust(s)  143  matched to or in the general vicinity of exhaust  471 . Accordingly, exhaust  471  is generally positioned toward the mid portion of one of the side panels of sterilizer  467 . Some sterilizers  467  assist the flow of the sterilizing agent(s) with a siphon or some type of flow assist, thereby facilitating the flow of the sterilizing agent(s) through sterilizer  467  and device  101  chambers to provide a more expedient and/or more efficient sterilization process.  
         [0017]    It will be recognized by those skilled in the art that steam and high temperature sterilization techniques have target temperatures substantially between 250 and 276 degrees Fahrenheit. This achieves at least two things. First, the relatively high temperature and/or moisture raised to high temperature kills germs and secondly, they alone or in combination provide positive pressure within sterilizier  467  and device  101  chambers as long as the chambers&#39; temperature is higher than ambient temperature outside the chambers. Thus, contaminants that may be introduced through handling of device  101  and its contents after the sterilization cycle are either destroyed or are pushed out of the chambers through the positive pressure.  
         [0018]    Furthermore, where device  101  is applied with steam sterilization techniques, in one of the embodiments of the present invention, the panels of device  101  are constructed of generally disposable materials and are sandwiched with a metalized coating or layer. The metal could be aluminum, although any generally corrosion resistant metal, alloy or material capable of withstanding high temperature and moisture could be employed. Where device  101  is applied with microwave, pulsed light, or electro beam sterilization techniques, in one of the embodiments of the present invention, the panels of device  101  are generally constructed of paper, fiber, plastic, or generally disposable materials that do not have an negative reaction when exposed to the described sterilization means. Yet in a third example, where device  101  is applied with acidic or corrosive sterilizing agents including, without limitation, parasitic acids or hydrogen peroxide, the panels of device  101  are generally constructed of plastic or fiber and/or are sandwiched with a metal, alloy or otherwise a material capable of withstanding the corrosive effects of the agents. One skilled in the art will select or choose from a number of materials or laminates to cover disposable materials that could comprise or cover panels of device  101  consistent with the requirements of a sterilization process employed.  
         [0019]    As shown in FIG. 3, rack  355  has a plurality of perforations or openings  357 . The perforations or openings can be of any number, shapes and dimensions or combination thereof, as long as rack  355  continues to substantially support and elevate the instruments and materials from bottom panel. As described above, rack  355  facilitates the sterilization process. As the panels, rack  355  is constructed or covered from materials substantially the same as device  101 , or compatible with device  101  as disclosed in this specification, or where the instruments are heavy, rack  355  may be constructed of a metal or alloy consistent with the sterilization process in which it is employed. In applications where the instruments or materials placed in device  101  are too heavy for its structure, device  101  may be architected and designed to support the heavier contents by means known in the art. Additionally, the user may apply a tray to support device  101  and its contents.  
         [0020]    Device  101  of the present invention may also be utilized as an aseptic storage and/or transport unit. The sterilized and usually wrapped materials are placed in device  101  and are placed in storage. The device of the present invention protects and prolongs the shelf life by preventing airborne particles, moisture and bellows-effect contamination from contaminating the sterilized contents. As described above, where device  101  is used in sterilization and its vent(s)  143  are opened, flaps  159 ,  161  and  163  cover vent(s)  143  thereby limiting airborne contaminants from entering into device  101  and contaminating its sterilized contents. Accordingly, one or more flaps  159 ,  161  and  163  should have dimensions sufficient to cover exhaust vent(s)  143 . Further, in other embodiments of the present invention, at least one or more flaps  159 ,  161  and  163  could be attachable to its respective panels  115 ,  117 ,  119  or  111 . A mild adhesive, tape, hasp and loop, or a hook and loop combination (such as Velcro®) as examples can serve as an exterior sterilization indicator and validation, facilitate attachment and prevent accidental opening and exposure.  
         [0021]    When the materials are called to service or are generally moved, device  101  provides an excellent transport facility, protecting its sterile contents from contaminants including, without limitation, airborne contaminants such as germs. As described in more detail above, the positive pressure within the chamber of device  101  allows a non-sterile technician to remove device  101  along with its sterilized items from sterilizer  467  and transport device  101  and its contents to the point of use. This eliminates the need for the risky practice of requiring the sterile scrub assistant to enter a non-sterile location to retrieve these items, and becoming contaminated in the process.  
         [0022]    Additionally, the device of the present invention allows the sterilized materials to remain on standby for emergency sterilization of non-sterile instruments or materials. In this mode, once the sterilized materials are delivered, the staff may choose to flash sterilize the contents with steam or high temperature (autoclave) agents, as an example. In another instance, the staff may wish to validate or revalidate the sterilization. As an example, the user would optionally remove some of the material from one or more panels  105 ,  107 ,  109  and/or  111  using perforations  145  creating exhaust vent(s)  143  and sterilize the contents again as described above.  
         [0023]    Sterilization monitoring methods are generally employed for cycle process validation. Each type of validation device (integrator) monitors a different set of parameters. The two basic types of tests are biological and chemical. For example, ethylene oxide and anprolene gas sterilizers, employ live spore biological testing devices utilizing Bacillus Subtilis organisms, plus gas sensitive color changing chemical sterilization integrator strips. For steam sterilization monitoring, biological testing with live spores of Bacillus Stearothermophilus, and chemical color changing sterilization integrator strips monitor the steam sterilant exposure parameters for each cycle. Vent(s)  143  of device  101  provide access to its interior/chamber for optimal placement of the spore biological tests and the chemical sterilization integrators. Through vent(s)  143  the extended portion of the monitoring devices protrudes exterior to device  101  for selective monitoring and device removal. This feature permits immediate access to sterilization process validation prior to lid closure with sealing off of vents  143 , and prior to removing device  101  and sterile contents from the sterilizer unit  467 . If vent(s)  143  are not employed for the monitoring process as described, aseptic removal of the monitoring devices would be delayed until their removal at the point of use. At the time of anticipated use, if the monitoring device indicates incomplete sterilization, the contents must be re-sterilized. This undesirable circumstance may occur in a location remote from the sterilizing location causing a potentially life threatening delay, which could have been avoided if the vent(s)  143  had been employed for chemical test strip retrieval from the sterilized invention for monitoring results, prior to removal from the sterilizer  467 .  
         [0024]    As mentioned above, device  101  used in a high temperature sterilization process facilitates the use of the integrators, as the high temperature provides positive pressure within the chamber of device  101  and thus rejects and/or destroys the contamination introduced by the user removing the integrator after the sterilization cycle. Yet in another embodiment, a view panel is integrated into one or more panels of device  101 , allowing the user to view the validation indicators. Thereafter, sterilized materials can be used, or as previously described, they can be stored in device  101  until required for a procedure.  
         [0025]    As discussed above, during and after the medical procedure, device  101  can be utilized as a receptacle and transport container for contaminated, biohazardous materials. The contaminated materials are placed in device  101  to limit the spread of the biohazardous materials and to provide a safe and efficient transport protecting the medical staff, bystanders and the environment from the contaminated materials. Additionally device  101  allows disposal or incineration of the biohazardous materials together with device  101 , without additional cleaning, sterilization, processing or segregation.  
         [0026]    Also as mentioned above, in one embodiment of the present invention, device  101  is resposable. It is designed for reuse or a single use and thus it is constructed from disposable materials such as cardboard, plastic, fiber, coated aluminum, with vinyl or epoxy matrix and the like. Having resposable device  101  allows the user to dispose of contaminated containers without having to sterilize them. This is advantageous because many sterilants and cleaning agents are corrosive and they degrade the integrity of the sterilization containers. This phenomenon leads to crazing and cracking of plastics, with pitting and corrosion of the containers made of materials as strong as stainless steel disturbing the smooth surface of these otherwise durable materials, and creating a safe haven for bacterial and other contaminants. Similar results are experienced with other materials such as plastics and laminates. Pitting, crazing corrosion and phenomenon disturbing the smooth, continuous plane of the container provides a safe haven for bacteria and contaminants and causes containers to lose their utilitarian function. Accordingly, disposing of device  101  is a cleaner, more economic and attractive alternative over disposing conventional containers made of stainless steel or alloys.  
         [0027]    Device  101  can also be utilized as a receptacle for contaminated instruments. Generally, once the instruments are contaminated or soiled, they are placed in device  101  and are transported to a cleaning and sterilization facility. In transport, device  101  shields the environment from biohazardous contamination. Thereafter, device  101  can be decontaminated and sterilized, disposed or placed back in service.  
         [0028]    As shown in FIG. 2, at least one of the panels  103 ,  105 ,  107 ,  109 ,  111  and  113  are laminated or constructed from a disposable material  251  such as cardboard, plastic, fiberglass, styrofoam, aluminum or like disposable materials known in the art. These materials preferably have sufficient characteristics to support the structure of device  101  or are formed or constructed in ways known in the art to provide the requisite support and structure. Additionally or alternatively, one or more panels  103 ,  105 ,  107 ,  109 ,  111  and  113  may be laminated coated with a material  253 . Material  253  may be chosen by its characteristics, utility, expense and/or function and for compatibility with sterilization/decontamination technologies such as microwave, steam-microwave, electron beam irradiation (e-beam), ultraviolet (UV) light, dry heat, convection heat, convection steam, gamma irradiation, hydrogen peroxide, ethylene oxide, ozone, steam (high speed gravity displacement) unwrapped method, steam gravity displacement unwrapped and wrapped methods, steam pulse-vacuum wrapped or unwrapped, steam pre-vacuum wrapped or unwrapped, paracetic acid, chlorine dioxide, gas plasma, formaldehyde-low temperature steam, microwave—bactericide, xenon lamp (broad spectrum pulsed-light), glass bead, vacuum ovens, heat conduction ovens, forced air ovens, solvent venting ovens, anprolene gas. As an example, a facility may choose laminate  253  by its compatibility with steam or e-beam sterilization or microwave sterilization. In other embodiments, one or more panels of device  101  may be fully or partially constructed from a material compatible with the above sterilization processes.  
         [0029]    In one embodiment (not shown) device  101  is shipped and stored in a flat form. When a new device  101  is needed, it is constructed. Thus, a number of containers  101  can be easily and efficiently stored in a small space. Top flap  113  can either be attached to one of the side panels  105 ,  107 ,  109  or  111  or it can be detached. In either mode, flap  113  encloses device  101  for clean transport and storage.  
         [0030]    While embodiments and implementations of the subject invention have been shown and described, it should be apparent that many more embodiments and implementations are within the scope of the subject invention. Accordingly, the invention is not to be restricted, except in light of the claims and their equivalents.