Abstract:
A method and apparatus for sterilization of infectious waste including animals, infected animal herds, infected human corpses and other infected material and proper disposal of resultant waste. The method and apparatus specifically relates to methods of safely sterilizing and disposing of infectious and non-infectious bio-waste in a cost effective manner.

Description:
CROSS REFERENCE 
     This application claims the benefit and priority of U.S. Provisional Patent Application Ser. No. 61/405,979, filed Oct. 22, 2010 entitled THERMAL TISSUE AUTOCLAVE, the entirety of which is incorporated herein by reference. 
     BACKGROUND OF INVENTION 
     1. Field of Invention 
     This invention relates generally to sterilization of infectious material and, more particularly, to sterilization of biological waste. 
     2. Background Art 
     Currently, universities, independent testing facilities and governmental agencies around the world produce or have political responsibility of large quantities of infectious animal waste due to research, study and containment. Additionally, future requirements to address pandemics can potentially add large numbers of animal carcasses and/or human cadavers which would require sterilization to insure containment of diseases. 
     Currently, the three methods commonly used in disposing of infectious waste such as infected animals or cadavers are incineration, burial and to a lesser extent alkaline hydrolysis. The known methods of disposal are faced with increasing regulations, including restrictions on waste water and land sites, environmental restrictions on air emissions, increased utility costs, as well as being faced with rising chemical costs in the case of using alkaline hydrolysis as a methodology. Thus, a less expensive and a more simplified approach to sterilizing and disposing of infectious material is needed, which is safe, more environmentally friendly and less expensive than existing sterilization methods and their subsequent disposal. 
     The various embodiments of the invention as described herein address the above issues and others. 
     BRIEF SUMMARY OF INVENTION 
     The present invention relates to the field of sterilization of infectious waste including animals, infected animal herds, infected human corpses and other infected material and to proper disposal of resultant waste. The invention relates to methods of safely sterilizing and disposing of infectious and non-infectious bio-waste in a cost effective manner. 
     One embodiment of the method of sterilizing a variety of infected material including animal and human corpses and/or parts includes the steps of providing a pressure holding vessel, loading the material into the vessel, heating the holding area of the vessel thereby energizing the material, for example, animal and/or human matter with external heat from either steam, electric, or other heat/energy source and agitating the material to effect size reduction of the material into a homogeneous, liquefied mixture. In one embodiment of the method the mixture can be heated to a temperature in the range of approximately 250 to 308 degrees F. at its equivalent saturated pressure and held approximately at that temperature for a period of approximately one to three hours to effect sterilization of the liquefied mixture. In one embodiment, the mixture can be cooled in the vessel and discharged. 
     One embodiment of the apparatus can include a vessel adapted for pressurization and having a heat source such a heating element heating a thermal fluid, powered by electrical current or other power source, that is operable to heat under pressure material placed in the chamber area of the vessel. One embodiment includes an agitator within the chamber of the vessel that is operable to agitate material contained therein and effect size reduction of the material. The agitator can effect a mechanical impact to the material in order to break and divide the material into smaller piece parts. The agitator can be configured to reduce the material to a sufficient small size to achieve a liquefied solution. The agitator can be a rotating blade type member that repetitively severs the material into smaller piece parts. However, the agitator need not be like a blade type member, as it can be a member that is not blade like, but is designed to mechanically impact the material repetitively with a rigid member, high pressure fluid or other agitation source and break it into smaller pieces. In one embodiment the apparatus the vessel can be designed with a chamber that can be pressurized and a heat source such that the mixture can be heated to a temperature in the range of approximately 250 to 308 degrees F. at its equivalent saturated pressure and held approximately at that temperature for a period of approximately one to three hours to effect sterilization of the liquefied mixture. One embodiment of the apparatus can also include a vessel having an internal mounting fixture adapted for inserting biological samples into a biological test chamber. The fixture can be designed such that it can be positioned in the liquid while maintaining agitator operation. 
     Various embodiments of the method and apparatus can provide a less expensive and a more simplified approach to sterilizing and disposing of infectious material that is clearly needed in the industry, that is safe and that is more environmentally friendly and less expensive than existing sterilization methods and their subsequent disposal. Also, various embodiments of the invention involve a method and apparatus for sterilizing animal carcasses, parts, infectious viruses and bacteria, human corpses, human parts, biological spores and other biological matter and is intended to comply with all governmental laws and regulations, national and provincial/state, applicable to disposal of such biological wastes. 
     These and other advantageous features of the present invention will be in part apparent and in part pointed out herein below. Further, U.S. Provisional Patent Application Ser. No. 61/405,979, filed Oct. 22, 2010 entitled THERMAL TISSUE AUTOCLAVE, the entirety of which is hereby incorporated herein by reference. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a better understanding of the present invention, reference may be made to the accompanying drawings in which: 
         FIG. 1  is a left perspective illustration of an embodiment of a sterilization system; 
         FIG. 2  is another left perspective illustration of the sterilization system; 
         FIG. 3  is another right perspective illustration of the sterilization system 
         FIG. 4  is a front view of the sterilization system; 
         FIG. 5  is a right side illustration of the sterilization system; 
         FIG. 6  is a left side illustration of the sterilization system; 
         FIG. 7  is a rear illustration of the sterilization system; 
         FIG. 8  is a sectional view of the sterilization system; 
         FIG. 9  is an illustration of the vessel chamber; and 
         FIG. 10  is a graphical illustration of a typical operational profile. 
     
    
    
     DRAWING ITEM LISTING 
     
         
         
           
               100  Sterilization System 
               102  Lid 
               103  Lid Hinge 
               104  Pressure Indicator 
               105  Lid Opening Cylinder 
               106  Monitoring Port 
               108  Temperature Sensor 
               110  Heating/Cooling Jacket 
               112  Discharge Valve 
               114  Discharge Valve Actuator 
               116  Thermal Liquid Inlet Port 
               118  Temperature Sensor 
               120  Gear Reducer 
               122  Drive Motor 
               124  Mounting Bracket 
               126  Operating Vent Pipe 
               128  Lid Locking Cylinder 
               130  Vapor Outlet 
               132  Combination Water and Caustic Inlet Port 
               133  Safety Vent Outlet 
               134  Thermal Liquid Outlet Port 
               135  Operating Vent Outlet 
               137  Pressure Transmitter 
               202  Port For High-Level Control ( 304 ) 
               204  Port For Safety Vent Outlet ( 133 ) and Pressure Transmitter ( 137 ) 
               206  Pressure Vessel Entry 
               302  Decontamination Product Valve 
               304  High-Level Control at Port ( 202 ) 
               305  Bio Test Port 
               306  Pressure Transmitter 
               308  Valve Actuator 
               402  Valve Actuator 
               404  Valve Actuator 
               802  Drive Transfer Seal Assembly 
               804  Arm Mount 
               806  Arm Mount 
               808  Mounting Ring 
               810  Agitator Arm 
               812  Agitator Blade 
               814  Pressure Vessel Lower Chamber 
               816  Drive Shaft 
               904  Discharge Port 
           
         
       
    
     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description presented herein are not intended to limit the invention to the particular embodiment disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims. 
     DETAILED DESCRIPTION OF INVENTION 
     According to the embodiment(s) of the present invention, various views are illustrated in  FIG. 1-10  and like reference numerals are being used consistently throughout to refer to like and corresponding parts of the invention for all of the various views and figures of the drawing. Also, please note that the first digit(s) of the reference number for a given item or part of the invention should correspond to the Fig. number in which the item or part is first identified. 
     One embodiment of the present invention comprising pressurized heat treatment and agitation system teaches a novel apparatus and method for sterilizing infectious material where one embodiment of the method can include placing biologically infected animal carcasses, tissue, bones and innards or other infectious material into a pressure vessel. One embodiment of the method can further include adding a quantity of water that can be from approximately 0% to approximately 20% of the tissue weight into the pressure vessel. Further, the method can include heating externally the chamber containing the material to bring the temperature of the vessel interior to the range from approximately 250 to approximately 308 degrees F. at a pressure ranging from approximately 0 to approximately 60 psig. This can be continued to effect degrading the waste material at these elevated temperatures and pressures. One embodiment of the process can include maintaining the environment of elevated temperature for a time period from approximately 0 to approximately 4 hours to raise the actual temperature of the tissue and other material, thereby effectively softening any biological tissue. 
     Agitating the material with an agitator can perform sizing the material thereby producing non-caustic discharge producing bone chards less than 1.5 inches and tissue fibers of diameters less than 0.015 inches. The process can be performed such that the solids are dispersed in the homogeneous mixture. If any caustic material is injected, it can be injected such that the discharged material has indistinguishable characteristics. 
     One embodiment of the method can include placing the animal carcasses, tissue, bones and innards into the pressure vessel and adding a quantity of water; between 0% and 20% of the tissue weight in the vessel. The vessel can be heated externally to bring the temperature of the vessel interior to the range of 250 to 308 degrees F. These elevated temperature and pressure conditions are conducive to completely degrading the waste material. The pressure range over the profile may range from 0 to 60 psig. 
     The tissue, bones and other waste matter, which may contain infectious viruses, bacteria, spores or prions can be allowed to remain in this environment of elevated temperature for a time period of 0 to 4 hours to raise the actual temperature of the tissue and other material. This period effectively softens the tissue and bone. 
     The agitator is designed to effect sizing reduction of any infectious material or waste including tissue, tendons, muscle and bones. The effectively reduced non-caustic discharge produces bone chards less than approximately 1.5 inches in diameter and tissue fibers of less than approximately 0.015 inches in diameter. If an option is exercised to introduce caustic injected material, the discharge mixture can have indistinguishable characteristics and dispersed solids. The effectively reduced material can be homogeneous and wax-like. 
     The agitator and chamber design can be such that a method and apparatus can be included to attach and detach biological sample containers that can be used for validating that the material has been adequately sterilized. One embodiment of such a method and apparatus is to provide an agitator without a centerline shaft and having an elongated bar like member with a circular shape or semi-circular shape or a member having a hemispherical configuration and having shafts on opposing sides for effecting rotation of the member. This embodiment avoids a problem that could be experienced if a rotor blade or implement having a center-line drive shaft is utilized. If such a center-line rotor is used, it could obstruct or hinder the insertion of the infectious material. With a center-line system, an operator when inserting material would have to navigate around the center-line drive shaft and rotors. The embodiment as described herein eliminates the center-line drive shaft and center-line rotor. The semi-circular or circular rotor can be position in the horizontal plane when inserting material such that the vessel has a central clear pathway from the loading hatch to the bottom of the vessel. 
     The agitator can be powered to provide sufficient impact force to thoroughly size reduce and mix the combination of water, solids, and fats. The agitator can also be designed to extend its reach to the interior perimeter of the inside walls of the chamber in order to clean the heat transfer surfaces of the chamber to insure satisfactory heat transfer coefficients. The agitator can be configured to provide a slight scraping or near scraping action to keep material from accumulating along the perimeter. One embodiment of the apparatus can also have an agitator configured and oriented to push or urge the final fibrous material to a centerline discharge port. Also, the agitator drive can include a variable frequency controller, which can allow the agitator to be started at a low rpm, for example one revolution per minute, and advance to approximately 20 revolutions per minute. Starting at a lower speed when the material parts are larger in one embodiment can allow for a greater torque at lower speeds and/or can reduce shock to the drivetrain. 
     One embodiment of the method and apparatus can provide a chamber with an internally mounted fixture, capable of inserting biological samples. The fixture can be designed such that it can be positioned in the liquid while maintaining agitator operation. 
     For one embodiment of the method, upon completion of the heat-up phase, the agitator can be started and run continuously for approximately 2 to 4 hours during which time the material goes through size reduction and physical milling to create a water-like mixture of suspended solids and water. As an option, during this phase small quantities of caustic, NaOH or KOH, may be injected into the mixture to effect saponification of the fatty acid derivatives and further molecular reduction of the proteins. This option is designed to maintain a pH of between about approximately 7 and 10.99. Less than 4% (less than 4% of the original tissue weight) of caustic solution can be introduced. 
     With or without the saponification step, this phase provides a complete sterilization of all elements of the material; assuring log 6 reduction criteria of infectious matter. The liquid is then available for two optional discharge modes. Existing technology typically injects a caustic portion into the initial load and then uses the dehydration on the digestate (includes animal tissue, additional water and caustic) to remove the water and produce a solidified mass. The difficulty with this is that the caustic saponifies the fats into soaps. These soaps have a high surface tension which can then create foam or belching during the dehydration phase, carrying solids and raising the Biological Oxygen Demand (BOD) level of the reclaimed water. This results in a very undesirable by-product which can be difficult to dispose of and can cause mechanical difficulties of blockage in pipes, heat exchangers and other restrictive devices over time. 
     One embodiment of the process design uses a unique introduction of a caustic to avoid the foaming issue and dehydrates the solids to a homogeneous solid mass and produces a clear, “lower BOD” reclaimed water, acceptable for discharge directly to a municipal waste water treatment facility. This embodiment of the process can raise the product up to 308 degree F. and agitate the product, which can provide size reduction of the animal tissue and bones into a water-like mixture of suspended solids. The pressure of the vessel can be reduced to approximately atmospheric pressure to effect a dehydration of the mixture and a step of collecting reclaimed water can be accomplished by a water condenser. One embodiment of the system can include system control logic capable of automatically determining the dehydration end point rather than using a form of trial and error methodology. With the addition of the condenser function, the over all system can be either a “wet” or “dry” discharge system. The condenser can be a direct contact condenser, an externally cooled condenser or a combination of both to achieve condensing and collection of the reclaimed water. 
     This embodiment of the process can introduce the caustic at end of the dehydration thereby allowing digestion and saponification to occur at lower levels of water content. The surface tension of the liquid mixture is greatly increased and attempts to distill water would result in carry-over of fatty acids and other material resulting in elevated BOD. The resultant discharged sludge can be very viscous and homogeneous and flowable at elevated temperatures and then solidifies upon cooling. A visual monitoring system can also be utilized to witness the process. 
     For an embodiment of the method and apparatus having a liquid discharge design, the vessel&#39;s thermal liquid can be cooled to indirectly cool the internal liquid. Upon cooling the internal liquid to less than about approximately 140 degrees F., the bottom discharge valve can be opened to discharge the sterile liquid to sewer or other appropriate receiver. The bottom discharge vale can be “flush mounted” such that there is no pipe to flange to valve interface creating a “dead leg” in the pipe area that is not heated thereby potentially creating an area where the liquid potentially could not be properly sterilized. 
     For an embodiment of the method and apparatus having a solid discharge, the vessel can continue the heating process and allow the pressure to be reduced to atmospheric conditions and released saturated vapors can be directed to a condenser where the water vapors are condensed and collected. This phase is tissue mass load size dependent and may operate from approximately 1 to 7 hours. The water collected may be partially recycled into the next load for re-use thereby improving environmental operation; and helping to meet “green” operational criteria. At its completion, the internal material is now a fibrous, sludge-like matter. It can be discharged through the bottom discharge valve. The discharge residue can be brown in color and can have small portions of fatty liquid which quickly solidifies into a wax-like product. The fibrous solids, upon cooling, are a rigid, solid mass. 
     One embodiment of the method and apparatus can utilize a monitoring system to visually monitor the operation of the process. The variety of animals and their respective variance in water to tissue ratio precludes an accurate mass or volume determination exact enough to determine process completion. The visual monitor provides such a method where repeatable interpretation of residue can be provided. 
     The details of the invention and various embodiments can be better understood by referring to the figures of the drawing. Referring to  FIG. 1 , a left perspective illustration of an embodiment of a sterilization system is shown. This view illustrates the pressure vessel having the Lid  102  in the closed position. The Lid  102  can be sealed and locked using the Lid Locking Cylinder  128 . If the Lid Locking Cylinder  128  is de-actuated, the Lid Opening Cylinder  105  can be utilized to retract the Lid  102  to the open position. The lid as shown in its closed position and sealed is the operating position of the lid. When the lid is sealed and closed, the vessel can be pressurized. In order to allow internal viewing of the vessel during operation, two monitoring ports  106  are provided. Cameras or other viewing mechanisms or systems can be mounted to these monitoring ports for viewing and/or recording the interior of the chamber when in operation. 
     Various sensors are utilized to monitor the operational conditions of the vessel. The sensors can include Temperature Sensors  108  and  118  which are adapted to monitor the internal temperature of the vessel. A Pressure Indicator  104  can also be utilized to monitor the interior pressure of the vessel. The various sensors can be communicably linked to a control system having a controller whereby temperature and pressure data and other sensor data can be transmitted to the control system which can in turn control the inputs to the sterilization system to vary the operational profile based on the data provided by the sensors. For example, the controller can control a heating system for regulating the temperature of the thermal liquid and can control the input of thermal liquid into the heating/cooling jacket in order to control the temperature within the vessel and thereby control the temperature of the material. 
     When the system is not in operation the Lid Opening Cylinder  105  can be utilized to retract the Lid Hinge to thereby open the Lid  102 . The Heating/Cooling Jacket  110  can be controlled by a controller system to heat or cool the interior of the vessel. The interior of the vessel can be heated or cooled to the desired temperature during the operational profile and once the operational profile is completed any sterilized material can be discharged through a Discharge Valve  112 . The controller can control the Discharge Valve Actuator to open the discharge valve to dispense of the sterilized material within the vessel. 
     During operation an Agitator Arm and Agitator Blade can be utilized to reduce the size of any waste material. The Actuator or Agitator can be powered by a Drive Motor and Gear Reducer  122  and  120  respectively. The control system can cause thermal liquid to be input through the Thermal Liquid Inlet Port  116  at a desired temperature to cause the Heating/Cooling Jacket to arrive at the desired temperature for the purpose of controlling the temperature of the interior of the vessel. Water and caustic material can be added to the interior of the vessel utilizing the Combination Water and Caustic Inlet Port  132 . Therefore, water and caustic material can be added to any infectious waste inserted within the vessel and the Heating/Cooling Jacket can be utilized to control the temperature of the interior of the vessel to thereby control the temperature of the infectious waste material and water contained therein. 
     The control system can monitor the interior pressure and temperature of the vessel and thereby control the temperature profile utilizing the Thermal Liquid Input Port  116 . During operation the Drive Motor  122  can be powered to drive the agitator to reduce the size of any infectious waste material. The system is also shown having a Vapor Outlet  130  which allows vapor to escape from the vessel while maintaining the desire pressure. The sterilization system also has a Safety Vent Pipe to allow pressure to be released from the interior of the vessel. Also Operating Vent Outlet  135  and Safety Vent Outlet  133  are provided. The thermal liquid can be discharged at the end of an operational cycle from the Heating/Cooling Jacket utilizing the Thermal Liquid Output Port  134 . The sterilization system can be properly mounted using the Mounting Brackets  124 . 
     Referring to  FIG. 2 , a another left perspective illustration of the sterilization system is shown. This illustration shows the Lid  102  in the open position. The Pressure Vessel Entry  206  is shown through which infectious waste material can be inserted into the pressure vessel. This interior view also reveals two Ports  202  and  204 . The ports are for high level control and safety vent outlet respectively. With the lid in the open position and the agitator oriented in a horizontal position, the material to be sterilized can be loaded. 
     Referring to  FIG. 3 , a right perspective illustration of the sterilization system is shown. This view again shows the Lid in the open position revealing the interior of the pressure vessel. This left perspective view reveals a Bio-Test port  305  through which biological samples (biological spore strips) can be inserted to validate sterilization efficacy. An Decontamination Product valve  302  is also shown. Various other control and sensing devices including pressure transmitter  306  and High-Level Control are shown. Various Ports, the Vapor Outlet  310  and water and caustic inlet  312  are also shown. 
     Referring to  FIG. 4 , a front view of the sterilization system is shown. This front view again shows the sterilization system with the Lid  102  in the closed position. Valve actuators  402 ,  308  and  404  are shown. The Viewing Ports  106  are also shown. The Lid Locking Cylinder  128  can be controlled by the control system to be actuated to seal the lid. A lid sensor can be utilized to monitor the seal and if the seal is disrupted a signal can be sent to the control system which can reestablish the seal or shut down the system as appropriate. 
     Referring to  FIG. 5 , a right side illustration of the sterilization system is shown. The right side view again reveals the various components including the Temperature Sensors  108  and  118 . Another view of the Lid Opening Cylinder  105  is also shown. The Cylinder  105  is shown in the extended position such that the Lid Hinges are positioned to close the lid in the sealed position. 
     Referring to  FIG. 6 , a left side illustration of the sterilization system is shown. This view again reveals the Drive Motor  122  and the Gear Reducer  120 . During operation the control system can control the Drive Motor  122  to drive the Agitator Arm and Agitator Blades at various and varying speeds to affect size reduction of any infectious waste solids inserted within the vessel. 
     Referring to  FIG. 7 , a rear illustration of the sterilization system is shown. The rear view again reveals the Lid Opening Cylinder  105  shown in the extended position to thereby close the Lid. The Thermal Liquid Input Port  116  is also shown which can be utilized to input thermal liquid into the Heating/Cooling Jacket to thereby control the temperature of the vessel. 
     Referring to  FIG. 8 , a sectional view of the sterilization system is shown. This sectional view reveals the interior of the vessel. Again the Pressure Vessel Entry  206  is shown through which infectious waste material can be inserted. This view also reveals one embodiment of an Agitator Arm and Agitator Blade  810  and  812  respectively. An end of an agitator arm can be powered by the Drive Motor  122  and the Gear Reducer  120 . The Drive Motor can be controlled to vary the speed and torque of the agitator to affect size reduction of any infectious waste material. The Gear Reducer can drive the Drive Shaft  816  which is sealed by the Drive Transfer Seal Assembly  802 . The agitator can be mounted by Arm Mounts  804  and  806 . The opposing side of the Agitator Arm can be mounted on the Mounting Ring  808  which allows rotation of the agitator as needed. Agitator Blade  812  as shown can be designed to be in a fixed position and/or can be designed to vary its position by rotating about an axis which is perpendicularly oriented with respect to the agitator arm. 
     Referring to  FIG. 9 , an illustration of the vessel chamber is shown. This view reveals the interior of the Pressure Vessel Lower Chamber  814 . The design of the Agitator Arm is such that the center pathway of the Pressure Vessel Entry is not obstructed by the agitator or by any of it components when it is positioned in a horizontal orientation. Therefore infectious waste material can be inserted within the chamber without attempting to navigate about a center agitator. The discharge port  904  is also shown at the bottom of the vessel chamber. 
     Referring to  FIG. 10 , a graphical illustration of one embodiment of a operational profile is shown. This graphical illustration is an illustration of one embodiment of an operational profile for treating five-hundred pounds of tissue mass and added water. 
     The various embodiments of the method and apparatus for sterilizing infectious waste and examples shown above illustrate a novel method and apparatus that provides a less expensive and a more simplified approach to sterilizing and disposing of infectious material that is clearly needed in the industry, that is safe and that is more environmentally friendly and less expensive than existing sterilization methods and their subsequent disposal. A user of the present invention may choose any of the above embodiments, or an equivalent thereof, depending upon the desired application. In this regard, it is recognized that various forms of the subject sterilization method and apparatus could be utilized without departing from the spirit and scope of the present invention. 
     As is evident from the foregoing description, certain aspects of the present invention are not limited by the particular details of the examples illustrated herein, and it is therefore contemplated that other modifications and applications, or equivalents thereof, will occur to those skilled in the art. It is accordingly intended that the claims shall cover all such modifications and applications that do not depart from the sprit and scope of the present invention. 
     Other aspects, objects and advantages of the present invention can be obtained from a study of the drawings, the disclosure and the appended claims.