Patent Publication Number: US-2021187511-A1

Title: Device and method of microbiology waste containment

Description:
RELATED APPLICATIONS 
     Domestic priority is claimed from U.S. patent application Ser. No. 14/747,664 filed Jun. 23, 2015 and entitled “Device and Method of Microbiology Waste Containment”, now U.S. Pat. No. 10,201,813 issued Feb. 12, 2019, which in turn claims priority to U.S. Provisional Patent Application No. 62/019,988 filed Jul. 2, 2014 and entitled “Device and Method of Microbiology Containment”, the teachings of all of which are entirely incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     This invention pertains generally to waste disposal, and more particularly to devices and methods for the capture for disposal of EPA regulated waste materials generated by conventional Microbiology/Histology/Pathology laboratories in hospital/laboratory settings. 
     Description of Related Art 
     Pursuant to the US Environmental Protection Agency&#39;s Resource Conservation and Recovery Act (40 CFR), a number of hazardous materials are supposed to be captured and disposed of in a safe manner, not simply flushed into the waterways. Unfortunately, otherwise regulated waste materials are currently being discharged by nearly every Microbiology/Histology/Pathology laboratory in every hospital/laboratory setting where microscopic slides are prepared into the publicly owned treatment works (POTW, i.e., down the drain). The current standard procedure is to suspend the microscope slides over a sink with a commercial metal slide holder and pour stain solutions over the slides, then rinse them. The resultant stain solutions and rinse go into the sink, staining the sink purple, and then eventually go down the drain to the POTW. 
     Despite the lack of a commercially available device to capture this effluent, the Laboratories (Waste Generators) are responsible for capturing this material for disposal as RCRA Hazardous Waste. Some are doing this, using a plastic tray in the sink under the slide rack. This is unacceptable because of the lack of containment and the very real possibility of the waste materials entering the POTW via the sink drain. 
     The waste materials include stain solutions containing Methanol (EPA D001, F003) and some metals, such as Chromium (EPA D007) and Silver (EPA D011). Such materials should not simply go down the drain of a sink. There is currently no commercially available device to address this issue. Accordingly, there is a long-felt need to provide a mechanism and method for preventing these toxic substances from simply being sent down the drain to the public water works. 
     SUMMARY OF THE INVENTION 
     The invention is an apparatus for capturing and enabling safe disposal of toxic waste products, especially those used in slide staining. In one embodiment, the apparatus includes an outer containment vessel and an inner containment vessel disposed inside the outer containment vessel. The outer containment vessel has an open area in its top section in which a specialized funnel can be placed. Optionally, support structures, such as a brackets or flanges, are provided in the outer containment vessel and the funnel rests thereatop. The funnel has a drain in communication with the inner containment vessel. When waste material is generated above the opening in the outer containment vessel, the waste material falls into and is collected by the funnel and conducted to the inner containment vessel where it is safely stored for subsequent removal/recycling/destruction. 
     In another embodiment, instead of an inner containment vessel, the outer containment vessel may be connected to an external containment vessel of significantly larger size (e.g., 5 gallons or more) than the abovementioned inner containment vessel. 
     Preferably, in either embodiment, the funnel has a support structure for supporting slides to be stained, so that when slides are stained with toxic substances, the excess stain is collected by the funnel and ends up in the inner/external waste containment vessel. 
     In another embodiment, a portable system involving containment of waste and having stain solutions and water for rinsing in a carrying case with a handle. This embodiment is ideal for field situations where a laboratory would be needed in a remote location. The use of this system will prevent the discharge of waste materials in the remote location, while allowing the microbiologist(s) to perform the needed diagnosis. Other staining procedures could be used in this manner. 
     By utilizing this invention, laboratories will avoid liability and non-compliance and prevent pollution from these materials. 
     The proposed devise will capture EPA-RCRA hazardous waste generated in microbiology laboratories during microscope slide staining processes. Each microbiology laboratory in every hospital or commercial laboratory will need this device to ensure compliance with RCRA (EPA) regulations. 
     This invention will capture the used stain and give the microbiologist a place to keep the working stains, all in a self-contained, closeable station, away from sinks and possible discharge. The kit(s) will also function as a satellite accumulation area for the waste effluent, with built in containment. By using a funnel and containment, the EPA waste and Waste/Product storage requirements are satisfied. There are also other staining applications such as the use of silver (D011) and Chromium (D007) for which this device would be applicable. 
     More specifically, the invention includes a microbiology waste containment apparatus. A primary containment vessel having side walls and an open top area is provided with a funnel in communication with the open top area. A secondary containment vessel is in fluid communication with the funnel. When microbiology waste is generated above the open top area (e.g., when staining a slide), the microbiology waste is collected by the funnel and conducted to the secondary containment vessel. Preferably, a slide staining support is disposed in one of i) the open top area, or ii) the funnel, and is adapted to support slides being prepared with chemicals that become microbiology waste following a slide staining procedure. 
     Optionally, the funnel is dimensioned substantially the same size as the open top area. Alternatively and preferably, the funnel further includes flanges adapted to engage a lip in the primary containment vessel just below the open top area. The flanges are preferably adjustable in length so as to accommodate primary containment vessels of different sizes. 
     In one embodiment, the secondary containment vessel includes an inner containment vessel disposable within the primary containment vessel. Alternatively, the secondary containment vessel includes an external containment vessel outside of the primary containment vessel. In either event, the funnel and the secondary containment vessel are typically connected by tubing. 
     Preferably, the primary containment vessel further includes storage space beneath the funnel for storing staining materials to be used in a slide staining procedure. 
     In one embodiment, the invention includes a lid lockable onto the primary containment vessel, and at least one handle disposed on an exterior of at least one of i) the lid, or ii) the primary containment vessel. In this configuration, the apparatus is self-contained and portable. 
     In another aspect of the invention, the invention includes a non-transitory computer-readable medium encoded with instructions for creating a microbiology waste containment apparatus. The medium includes instructions for creating a primary containment vessel having side walls and an open top area; instructions for creating a funnel adapted to be in communication with the open top area; and instructions for creating a secondary containment vessel adapted to be in fluid communication with the funnel. When the primary containment vessel, the funnel, and the secondary containment vessel are connected together, microbiology waste generated above the open top area is collected by the funnel and conducted to the secondary containment vessel. 
     In one embodiment, the instructions for creating the secondary containment vessel further include instructions for creating an inner containment vessel disposable within the primary containment vessel. In addition or in the alternative, the instructions for creating the secondary containment vessel further include instructions for creating an external containment vessel outside of and connectable to the primary containment vessel. 
     Optionally, the instructions further include instructions for creating a lid lockable onto the primary containment vessel; and instructions for creating at least one handle disposed on an exterior of at least one of i) the lid, or ii) the primary containment vessel. When created and assembled, the microbiology waste containment apparatus is self-contained and portable. 
     In another aspect of the invention, the invention includes a method of containing microbiology waste. A primary containment vessel is provided having side walls and an open top area. A funnel is provided in communication with the open top area. A secondary containment vessel is provided in fluid communication with the funnel. A microbiology slide staining procedure is performed above the open top area. The microbiology waste generated by the performing step is collected by the funnel. Finally, the waste collected by the funnel is conducted to the secondary containment vessel. As above, the secondary containment vessel in this method may be an inner containment vessel, in which case the method further includes the step of disposing the inner containment vessel within the primary containment vessel. In addition or in the alternative, the secondary containment vessel may be an external containment vessel, in which case the method further includes the step of disposing the external containment vessel outside of the primary containment vessel. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A-B : Lateral and dorsal view of a funnel, showing positions of drains, dowells, and brackets, in accordance with the invention. 
         FIG. 2 : Dorsal and lateral view of alternative rounded edge funnel brackets, in accordance with the invention. 
         FIG. 3 : Dorsal and lateral view of alternative square edge funnel brackets, in accordance with the invention. 
         FIGS. 4A-B : Lateral and dorsal views, respectively, of inner waste containment vessel, in accordance with the invention. 
         FIG. 5 : Lateral view of outer containment vessel, in accordance with the invention. 
         FIG. 6 : Side sectional view of funnel and inner containment vessel connected to each other and disposed within the outer containment vessel, in accordance with the invention. 
         FIG. 7 : Side sectional view of funnel disposed within the outer containment vessel and connected to larger external containment vessel, in accordance with the invention. 
         FIG. 8 : Schematic depicting dorsal and side signage for the device, especially the outer containment vessel. 
         FIGS. 9 and 10 : Showing relative position of stain solutions located in the outer containment vessel, either next to the interior waste containment vessel ( FIG. 9 ) or in the containment vessel when the outer (extrinsic) waste container is in use ( FIG. 10 ). 
         FIGS. 11  A-B: Lateral and dorsal views, respectively, of lid which covers the vessel and can function as containment for the microscope slides prior to being stained or as a staging area for processed microscope slides. 
         FIGS. 12A-B  is a schematic of a fully self-contained and portable microbiology staining and waste containment kit in accordance with the invention.  FIG. 12A  shows the kit with the lid open, and  FIG. 12B  shows the kit with the lid closed. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION AND DRAWINGS 
     Description will now be given with reference to the attached  FIGS. 1-12 . It should be understood that these figures are exemplary in nature and in no way serve to limit the scope of the invention, which is defined by the claims appearing hereinbelow. All dimensions, materials, and the like are also exemplary in nature and can be replaced with other dimensions, materials, and the like without departing from the scope of the invention where practical and advantageous. 
     Components: 
     Primary outer containment vessel  10  (see  FIG. 5 ). A plastic box product preferably, in one embodiment, of the dimensions 18″ long (outside), 12″ wide (outside), 13% Outer height and 12½″ inner height with a lip around the top 1⅛″ distally, and the 1⅛″ up creating a rim  11 . One or more sealable exit ports  12  (one shown in  FIG. 7 ) are provided for plastic tubing in the center (6.5″) of the width side, and 6½″ from the bottom, one on either side. The exit ports are to accommodate tubing, e.g., 5/16 ID tubing, which may be fed to a larger (e.g., 5 Gallon) external labeled waste vessel (see  FIG. 7 ). The port gives laboratories that generate larger volume the option of conveniently capturing that volume. The tube, space permitting, could be fed to an even larger container, as allowable by local and federal authorities. For example, at the time of this writing, EPA regulations allow a maximum of 55 gallon of waste in a Satellite Accumulation Area for a period of no more than one year. Many states, such as New York, are more stringent and only allow accumulation for 180 days. The City of New York Fire Code allows no more than a total of 30 Gallons of flammable liquids per laboratory space, including both product and waste. 
     The interior  14  of the outer containment vessel  10  has sufficient room for the stain solutions  6 ,  7 , and  8  (see  FIGS. 9 and 10 ), which should be labeled on the top of the bottle as to contents by the user. The interior space also allows the manipulation of the drain and fill valves that leave and enter the two interior components. 
     Each Length side of the outer containment vessel will preferably be labeled with appropriate warnings, such as shown in  FIG. 8  and including optionally the following: 
     Microbiology Containment and Satellite Accumulation Area. 
     Please keep closed when not in use. 
     Full waste containers must be brought to the Central (Main) Accumulation Area within 72 hours. 
     No waste may be stored for more than ______ days (as per state and/or federal regulations). 
     Label stating contents (Methanol Stain) and start date. 
     Warning labels may be placed on other locations of outer containment vessel  10 . 
     Lid  20  (see  FIGS. 11A-B ): Lid  20  is made to fit with this modified commercially available product. This cover closes the entire unit and can function as containment when placed upside down on a flat surface. The inner components can be placed upon the upside down lid during maintenance operations. The top of the lid shall be labeled appropriately, e.g. as follows: 
     Microbiology Containment and Satellite Accumulation Area 
     Please keep closed when not in use. 
     Full waste containers must be brought to the Central (Main) Accumulation Area within 72 hours. 
     No waste may be stored for more than [X] days (as per state and/or federal regulations). 
     Label stating contents (Methanol Stain) and start date. 
     Secondary Containment Vessel Option 1: 
     Inner Waste Accumulation Vessel  30  (see  FIGS. 4A-B ): This is to enable microbiology laboratories with small volume and or limited space to accumulate waste into a reusable container that can be decanted into a larger vessel in the Central (Main) Accumulation Area. 
     In one embodiment, the dimensions of vessel  30  are: 17″ Length, 7″ width, and 4″ height. The dorsal surface  32  preferably has a handle  34  located 11″ from the filling end, a vent  35  about 2¼″ on center from the vent end, and a fill port  36  with a valve cap  38  3″ on center from the filling end. The filling end is connected to the funnel  40  via a piece of 5/16 inner diameter (ID) tubing  31  to the fill port  36 . A separate solid cap (not shown) is supplied to seal the collection vessel so that another one can be put into place. Another valved cap (not shown) can be used to decant the waste into a larger container in the Central Accumulation Area. This container  30  shall be labelled as to contents with a date within regulatory limits. When this container  30  is full, container  30  (or the contents of container  30 ), are supposed to be removed to the Central Accumulation Area within 72 hours or the like. 
     Microbiology Funnel  40  (see  FIG. 1 ): The length of the exemplary funnel body is preferably 14 inches. In one embodiment, the width of the funnel body  6  and ⅛ inches. On each width end is a 1-inch telescoping flange  42  to hold the funnel on/in the upper lip portion  11  of the outer containment vessel  10 . It is to fit so that funnel  40  may be slid width-wise in the containment box  10  easily with minimal forward/backward motion. The attachment flanges  42  are adjustable to give the user options. In the preferred embodiment, flanges  42  are made from a stiff wire or coated wire-type structure. An alternative flange  42 ′ with rounded edges is shown in  FIG. 2 , and an alternative flange  42 ″ with square support surfaces is shown in  FIG. 3 . Flanges  42 ′ and  42 ″ are optionally interchangeable with flange  42  to give the user options of applications, such as using different containerization, among other things. As another alternative, funnel  40  is simply dimensioned to sit atop outer containment vessel  10  without adjustable flanges, e.g., either with fixed/permanent flanges or with no flanges per se. 
     In one embodiment, the maximum depth of funnel  40  is preferably 2½ inches at the fill end, centered on 4 inches lengthwise. From the point of 4 inches from the “back” funnel wall, the floor of the funnel ramps up to 1½ inches at the other end, for a distance of Run 10 inches, a Hypotenuse 11 inches, with a drop of 1 inch from the “higher” end to the drain end. At each end, slightly recessed from the funnel lip (½ inch), are brackets  44  located 1% inches width at the widest on center to hold two parallel dowels  46  for supporting microscope slides during staining procedures. Although the dowels may be round in section, preferably they have a flattened upper surface so as to provide greater surface area of support for the slides and deter slipping of the slides during staining. Alternatively, slide support dowels  46  may be attachable to outer containment vessel  10  above funnel  40 . Additionally, the upper surface of dowels  46  may be provided with a high coefficient of friction (e.g., a non-slip and non-reactive material, or the same material but made rough, etc.) to deter slipping of the slides during staining even further. This may not be necessary as most slideracks are smooth and the weight of the glass is sufficient to keep the slide relatively immobile, even when they are being sprayed with staining material. In any case, dowels  46  are preferably removable for cleaning and replacement purposes. The top of the dowels is ¼ inches recessed from the top of the funnel. The dowels need be no more than ¼ inches in diameter. 
     The funnel drain  48  is located 2 inches on center from the “deep” end. The drain port feeds into a ball valve tube  49  (see  FIG. 6 ). The ball valve drain tube  49  is attached to plastic tubing  31  which feeds into either the inner waste containment vessel  30  or through one of the ports  12  (located on either “narrow” side) into a larger, contained, waste accumulation vessel. 
     This device is preferably manufactured from injection molded chemically resistant polypropylene or a similar polymeric or otherwise non-reactive material. 
     In operation, the invention is used as follows. 
     Place the entire apparatus  5  on a flat surface. 
     Remove the lid  20  from the primary containment vessel  10  and place upside down (open side up) on a flat surface. The upside down lid  20  may be utilized as containment for the working slides or any other material utilized in the staining process not contained in the outer containment vessel  10 . Assemble the drain cap on the funnel and put the valve in the closed position, with the valve handle across the flow direction. 
     Option 1 (see  FIG. 6 ): 
     Using 5/16 ID tubing, connect the funnel valve to the fill valve on the inner waste collection vessel. 
     Examine the connections to ensure a liquid tight fit. 
     Open the vent  35  in the back end (near the handle  34 ) of the inner collection vessel  30 . 
     Open the drain valve  49  on the bottom of the funnel and the fill valve  38  on top of the inner waste containment vessel  30 . Label the collection (inner containment) vessel  30  as to content (for example Methanol Stain) with a start date within 180 days (or 1 year, if applicable). Label the working stain solutions  6 ,  7 ,  8  (product) dorsally as to content, in plain and clear language, and place in the outer containment box  10  in storage area  13  between the inner containment vessel  30  and the near outer containment vessel wall. 
     Begin staining and monitor the inner containment vessel  30  so as not to overfill. The inner containment vessel  30  is preferably manufactured out of semi-opaque white plastic. As this will soon be opaque from the waste stain solution, the level may be monitored by observing the level in the container through the vent port, at the opposite end of the fill port on the vessel. (Optionally, a clear section may be formed in inner containment vessel  30 .) Take care not to overfill, however if overfilling occurs, it is not a big problem because the waste material is still contained by the outer containment vessel  10 . 
     When full, decant inner containment vessel  30  into a larger container in the Central Accumulation Area or seal and replace the container after placing the full container in the Central (Main) Accumulation area. Label the container as to contents and date the container utilizing a Hazardous Waste Accumulation label. (Exemplary contents: Methanol Stain Solutions.) 
     Option 2 (see  FIG. 7 ): 
     Using 5/16 inner diameter tubing  31 , run the tubing through one of the side ports  12  in the outer containment vessel  10  to an external waste container and connect to the funnel drain valve  49 . If so desired, put another valve (not shown) on the drain end entering the collection container. Label the external waste container as to content and date within 180 days or 1 year if applicable. Preferably provide spill control containment in or on the external waste container. If the external waste container is a five gallon plastic pail, the outer containment vessel should be large enough to contain 5 gallons of liquid. 
     Examine the connections from the funnel valve  49  and at the external waste container to ensure a liquid tight fit. 
     Open the valves. 
     Begin staining and monitor the waste container(s) so as not to overfill. 
     When full, move the labeled full container in the Central (Main) Accumulation Area and replace with an empty labeled container. 
     When complete or leaving the room, please make sure waste collection vessels are closed. Please make sure the drain valves are in the closed (cross stream) position. Please place the lid on the device. 
     The invention is not limited to the above description. For example, the funnel, with either flange attachment, may be used over a different waste collection container or outer containment vessel as the Waste Generator so chooses. The generator should be mindful of containment with whichever option is used. Also, the wholly contained system having the inner secondary containment vessel is aptly designed for portable use, e.g., either to be carried from one location in a lab to another or from one lab to another, or for use in the field, e.g., during a rural disease outbreak, during wartime, etc. In such cases, as shown in  FIGS. 12A-B , the lid will preferably lock to the outer containment vessel  10  via locking mechanism  60 , and the device will include one or more handles  62 , either disposed on the exterior of the lid, or on the exterior of the outer containment vessel, or the like. In the embodiment of  FIG. 12 , lid  20 ′ may be hingedly attached to outer vessel  10  via hinges  64  so as not to get separated. Alternatively, the lid could be completely removable from vessel  10  and still lock thereto, e.g., via mason-jar-type clips, or the like. In either event, funnel  40  may be stored upside-down atop inner containment vessel  30  as shown in  FIG. 12B . Funnel flanges  42  may telescope out of the way as mentioned above, or they may be hinged to fold out of the way, or be otherwise detachable and storable within vessel  10 . 
     Additionally, the invention includes a non-transitory computer readable medium having instructions for making the above apparatus. The methods of making the apparatus can include additive manufacturing such as “3D printing” as well as any known or to be developed methods of manufacturing. 
     Having described certain embodiments of the invention, it should be understood that the invention is not limited to the above description or the attached exemplary drawings. Rather, the scope of the invention is defined by the claims appearing below and includes any equivalents thereof as would be appreciated by one of ordinary skill in the art.