Abstract:
A novel collection device for collection, storage and disposal of biological products, in conjunction with an improved cleansing method. Disclosed is an apparatus which includes a locking closing member handle to allow for safe transport and disposal of medical waste. Closing member allows for secure containment of medical waste and subsequent apparatus cleaning. Closing member design includes a gap between closing member and housing which facilitates device cleaning after waste disposal.

Description:
RELATED APPLICATIONS 
     This application is a divisional application of Ser. No. 11/190,217 filed on Jun. 26, 2005 and incorporated herein by reference. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     1. Field of the Disclosure 
     This disclosure relates to the storage and disposal of biological waste materials. More particularly, the disclosure relates to modular containment devices which provide for controlled collection of biological waste materials. Even more particularly, the disclosure relates to modular containment devices which guard against undesired spillage while allowing for automated cleaning of the assembly as well as the containment vessel. 
     2. Background Art 
     Safe and economical handling of medical waste faces a number of hurdles. Devices for containment of medical waste must withstand a wide range of temperatures, pH variations, positive and negative pressure forces, and chemical degradation from exposure to complex organic molecules. Medical waste is rarely homogenous, with liquid waste containing solid matter and generating gaseous byproducts. Secure containment of the same requires addressing all of the above concerns. 
     Modular medical waste disposal systems help address this need, but can still expose health care workers to risks during disposal of the waste and cleaning of the container. Consequently, there has been a long felt need for a device to aid storage and automate waste disposal of medical waste and provide for better container cleaning. Such an improved device would improve health care worker safety and help reduce exposure to hazardous organic materials. Medical waste disposal systems such as those disclosed in U.S. Pat. Nos. 6,027,490 and 6,488,675 are hereby incorporated by reference. 
     SUMMARY OF THE DISCLOSURE 
     Accordingly, this disclosure provides an apparatus for containment of biological waste materials with improved storage, handling, disposal and cleaning characteristics. This disclosure includes an assembly which is seated atop a vessel for biological waste storage. The assembly allows for passage of biological materials into the vessel, and also includes a manual control and closing member to seal the vessel for transportation to a waste disposal station. 
     To improve health care worker safety, the assembly guards against unintended waste spillage through the inclusion of a closing member operated by a knob which is automatically locked when turned to the ‘closed’ position. Consequently, the assembly must be manually unlocked in order for the vessel to be emptied of its contents. Quick entry and release grooves incorporated into the top of the assembly allow for sealed connection to a waste disposal device, which can detect closing member pressure and position due to the incorporation of a magnet into the lock release button. Button position can be derived from magnetic or other sensors located on a biofluid disposal station, and are derived by the position of the assembly relative to the disposal device. To improve operator efficiency and versatility of the system a sensor feature is incorporated into the assembly/vessel structure and the wash disposal station. Magnetic or RF signals located on the vessel assembly instruct the disposal station of the appropriate process of data collection. 
     Improved handling of biological materials creates additional structural considerations in apparatus design. Health care worker safety is improved by making the assembly shatter resistant as well as leak resistant. Devices for containment of biological materials such as medical waste must withstand a wide range of handling abuses in use and transport and temperatures and pressure ranges since collection and cleansing are likely to occur at substantially different positive and negative atmospheric pressures. Complex organic molecules impact on their surroundings with pH variations, and the assembly must be resistant to chemical degradation from exposure to complex organic molecules. Composition of the assembly and its inner workings must take into account all of these concerns. 
     Apparatus component layout also has resulted in operational improvements over previous devices. Connection of the apparatus to a waste removal station is facilitated through quick attachment and release grooves, which provide a sealed discharge path to a mated receiving chamber adapter to safely discharge vessel contents. To improve working efficiency and reliability the apparatus has been designed with a minimum of gaskets and pivot points. The two-point mounting design for the closing member allows for operational simplicity while providing for controlled engagement of the gaskets. Biological material disposal is improved due to the radiused lumen entry port of the closing member which reduces ‘sticktion’ and enables the low torque required for closing member opening and closing. The adjustable closing member seating ring is threaded and allows for compression adjustment of the closing member and gaskets based upon the number of revolutions the closing member seating ring has been inserted into the apparatus housing. The apparatus housing internal chamber has a larger volume and internal dimensions than the apparatus closing member. This expanded chamber coupled with the flattened ball surface to access and direct cleaning fluids to enter the internal chamber of the housing and two-point closing member pivot mounting approach allows for cleaning fluid to access all internal housing and closing member surfaces. As a consequence, apparatus reliability is high and cleaning of apparatus internal components is optimized. 
     Finally, medical waste is rarely homogenous, with liquid waste containing solid matter and generating gaseous byproducts. Consequently, the apparatus disclosed herein provides for enhanced device cleansing through the introduction of a gap between the closing member system and external assembly, allowing for improved automatic cleaning of the assembly after the vessel has been emptied. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a better understanding of the disclosure, reference is made to the accompanying drawings numbered below. Commonly used reference numbers identify the same or equivalent parts of the disclosed apparatus throughout the several figures. 
         FIG. 1  is a top perspective view of the assembled apparatus. 
         FIG. 2  is an exploded view of apparatus. 
         FIG. 3  is a top elevated perspective section view of housing. 
         FIG. 4  is a top perspective view of closing member. 
         FIG. 5  is a top elevated perspective section view of closing member. 
         FIG. 6  is a top elevated perspective section view of closing member. 
         FIG. 7  is a top perspective view of housing  1 . 
         FIG. 8  is a top elevated perspective section view of the assembled apparatus. 
         FIG. 9  is a top elevated perspective section view of the assembled apparatus. 
         FIG. 10  is a cross sectional view of the assembled apparatus when it is in the ‘open’ position. 
         FIG. 11  is a top elevated perspective section view of the assembled apparatus incorporated into a waste station with alternate valve embodiment. 
         FIG. 12  is a plan view of the assembled apparatus when it is in the ‘open’ position. 
         FIG. 13  is a top elevated perspective section view of the assembled apparatus incorporated into a waste station. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIG. 1  is a perspective view of the assembled apparatus. When assembled, housing  1  can be seen with closing member handle  93  and button  121 . Since closing member handle is turned to the unlocked and open position, closing member  71  can be seen with angled opening portion  79  of the lumen radiused to facilitate passage of waste (not shown) and subsequent cleaning, straight portion  89  and gap  191  between housing  1  and closing member  71 , allowing for greater surface area cleansing of closing member  71  and related parts. The external surface of closing member handle  93  is made up of handle  95  connected to handle face  197  with handle face raised feature  99 . 
       FIG. 2  is an exploded view of the apparatus and details of the component parts. Starting with the top of the Figure, housing  1  is shown above closing member  71 , closing member seal  101  and upper closing member gasket  109 , lower closing member gasket  127 , all of which seat into closing member seating ring  151 . Depicted across from housing  1  is closing member handle  93 , closing member handle gasket  113 , handle locking button  121 , spring  131  and magnet  141 . Closing member seating ring  151  is used to secure closing member  71  to housing  1 . Leakage from closing member  71  at the vessel end is prevented by gaskets  109 ,  127  and closing member seal  101 . Closing member handle gasket  113  seats into closing member handle gasket seat  53  to prevent ingress and egress of collected biological material (not shown). Upper closing member gasket  109  seats into upper closing member gasket seat  295 , lower closing member seal seats into lower closing member seat  177  and closing member seal  101  seats into closing member seal seat  153  to prevent ingress and egress of collected biological material (not shown). Gasket  109 ,  113 ,  127  and seal  101  are made out of suitable material to minimize thermal or pH degradation during operation of the apparatus while providing consistent sealing properties between the closing member  71  and housing  1  over time. In addition to providing orientation indentations for closing member gasket  109  and closing member seal  101 , closing member seating ring  151  is threaded  155 , concave and contains two tightening facilitator bumps  157 ,  159  on the opposite side of closing member seal seat  153 . Closing member seal  101  is made out of suitable material to minimize thermal or pH degradation during operation of the apparatus while providing consistent sealing properties between the closing member  71  and housing  1  over time. During assembly, closing member handle  93  is press fitted into closing member handle orifice  81  to provide for manipulation of closing member  71 . Closing member handle  93  is also designed to slightly flex during assembly with closing member  71  through housing  1  handle orifice  33 . Closing member handle  93  has a handle  95  for manipulation of closing member  71 . Range of motion of closing member handle  93  is determined by the closing member stop (not shown) and angled closing member stop (not shown) opposite handle face  197 . Both function in cooperation with reciprocal notched facets of housing  1 . Closing member handle  93  includes closing member handle gasket seat (not shown) to seat closing member handle gasket  113  to prevent ingress and egress of collected biological material (not shown). Closing member handle shaft  103  in one variant is hollow and terminates with closing member handle shaft locking tabs  209 ,  111  as well as a pair of notches  115 , (not shown) to reduce the opposite end of closing member handle  93  from a round conformation to an oblong one. The straight, parallel sides at the non-handle end of closing member handle  93  allow for closing member handle  93  to impart a rotational force on closing member  71 . This is possible when closing member handle  93  is seated into closing member  71  at the closing member concave indentation  81 . Closing member concave indentation  81  also includes two pockets  83 ,  85  for seating the closing member shaft locking tabs  209 ,  111 . To provide for additional rotational purchase, closing member handle  93  terminates with the ‘u shaped’ member  211  and allows for installation of closing member handle  93  into concave indentation  81 . 
       FIG. 3  is a top elevated perspective section view of housing  1 . Housing  1  provides a ridge  11  to support waste removal. Connection with a collection or removal device (not shown) is achieved through the insertion and rotation of the apparatus along the receptacle neck grooves  7  until rotation is no longer possible and housing  1  is secured into position by receptacle neck groove stop locks  9 . Button indentation  15  surrounds spring position post  19 . Placement of closing member (not shown) is determined by rotation pin indentation  35 , which is centered across from handle orifice  33 . Inside housing  1 , threaded grooves  49  provide for insertion and tightening equivalently threaded articles. 
       FIG. 4  is a top perspective view of closing member  71 . Closing member  71  is substantially spherical, yet includes a lumened cylindrical waste passage  73 . Also shown is the substantially oblong closing member concave indentation  81  for receiving closing member handle (not shown) which seats onto closing member locking tab indentations  85 . Closing member  71  has a flat face  83  which is rotated into position during closing member operation, where the surface of flat face  83  meets the spherical surface of closing member  71  is a radiused surface  151  which assists in directing the cleaning fluid entering the housing chamber  1 . 
       FIG. 5  is a top elevated perspective section view of closing member  71 . Rotation pin  81  is cylindrical and allows for seating of the closing member and turning on a single axis. Opposite rotation pin  81  is a substantially oblong closing member concave indentation  87  for receiving closing member handle (not shown) which is locked into position by closing member handle shaft locking tabs (not shown) which seat into closing member locking tab indentations  85 ,  185 . 
       FIG. 6  is a top elevated perspective section view of closing member  71 . Closing member  71  is substantially spherical, yet includes a lumened cylindrical waste passage  73 . Rotation pin  81  is cylindrical and allows for seating of the closing member and turning on a single axis. The one end  77  of cylindrical waste passage is radiused to include an angled opening portion  79  to facilitate passage of waste (not shown) and subsequent cleaning. This feature is also used to align the collection manifold (not shown). Closing member handle (not shown) is locked into position by closing member handle shaft locking tabs (not shown) which seat into closing member locking tab indentations  85 ,  185 . The angled opening portion  79  also improves passage of materials through radiused surface  150  at the seal interface (not shown) resulting in reduced ‘sticktion’ and closing member turning properties.  29   FIG. 7  is a top perspective view of housing  1 . Housing  1  encloses the internal workings of the assembled apparatus and provides ports  201 ,  205  for biological waste ingress and egress. Starting from the biological materials intake end  205  and working towards the biological materials removal end  201 , the apparatus provides for secure storage of biological materials through the connection of a receptacle (not shown) with the apparatus. Housing  1  also has exterior flanges  41 ,  43  to facilitate positioning the apparatus with other devices. Housing  1  also has indentation  47  to guide placement of locking screw (not shown) to align housing  1  with fluid container (not shown) attached to intake end  205 . On the exterior of housing  1 , handle orifice  33  has a semi circumferential raised ridge  37  to limit the range of rotation of closing member handle (not shown). Turning now to the inside of the device, housing  1  expands to allow for insertion of closing member (not shown). Positioning of closing member (not shown) inside housing  1  is determined by the location of optional rotation pin indentation  35 , which is centered across from handle orifice  33 . Inside housing  1 , threaded grooves  49  provide for insertion and tightening of closing member seating ring (not shown). 
       FIG. 8  is a top elevated perspective section view of the assembled apparatus  301  when it is in the ‘closed’ position, with flat face  83  rotated to prevent passage of contained materials (not shown).  FIG. 8  shows housing  1  assembled with closing member  71  and closing member handle  93 . Because closing member  71  is in the ‘closed’ orientation, position of closing member handle  93  is locked into place by handle locking button  121 . Button  121  returns to position by the tension provided by spring  131 . Leaks are prevented through the use of closing member handle gasket  113  in conjunction with the closing member seal  101 , upper seating gasket  109  and lower seating gasket  127 , all of which seat into closing member seating ring  151 . Housing  1  surrounds spring position post  19 , and it is large enough to accommodate button  121 , spring  131  and magnet  141 . Closing member handle locking button  121  is seated into housing  1  once closing member handle locking button return spring  131  and magnet  141  are placed into button  121 . In this assembled view, magnet  141  is positioned inside the hollow cavity of closing member handle locking button  121 . Closing member handle locking button return spring  131  allows for button  121  to lock closing member handle  93  into a closed configuration. Spring  131  and magnet  141  are kept in place by spring seating column  123  and magnet rails  125  respectively. Threaded grooves  49  provide for insertion and tightening of closing member seating ring  151 . 
       FIG. 9  is a top elevated perspective section view of the assembled apparatus  301  when it is in the ‘open’ position.  FIG. 9  shows housing  1  assembled with closing member  71  and closing member handle  93 . Leaks are prevented through the use of closing member handle gasket  113  in conjunction with the closing member seal  101  and upper seating gasket  109 , lower seating gasket  127 , all of which seat into closing member seating ring  151 . Inside housing  1 , threaded grooves  49  provide for insertion and tightening of closing member seating ring  151 . Closing member seating ring  151  is used to secure closing member  71  to housing  1 . Closing member  71  is seated into housing  1  by the use of optional rotation pin  81 . Optional rotation pin  81  is cylindrical and allows for seating of the closing member and turning on a single axis. Closing member handle  93  has a handle  95  for manipulation of closing member  71 . Closing member handle shaft  103  is hollow and terminates with closing member handle shaft locking tabs  209 ,  111 . Closing member handle  93  is locked into position by closing member handle shaft locking tabs  209 ,  111 . In the pictured ‘open’ position, closing member  71  provides close contact with seal  101  to minimize waste leakage into apparatus during disposal. To maximize sealing, a non-reactive lubricant or grease (not shown) can also be added. Closing member seating ring  151  is threaded  155 , concave and contains tightening facilitator bumps  157 .  FIG. 9  details how closing member  71  angled opening portion  79  is oriented to facilitate passage of waste (not shown) and positioned for subsequent cleaning which is enhanced with gap  191  between housing  1  and closing member  71 . Gap  191  exists between housing  1  and closing member  71  when closing member  71  is open to allow for greater surface area cleansing of closing member  71  and related parts. 
       FIG. 10  is a cross sectional view of the assembled apparatus when it is in the ‘open’ position.  FIG. 10  shows housing  1  assembled with closing member  71 . Closing member  71  is substantially spherical, yet includes a flat face  83  which is rotated into position during closing member operation. In the present illustration, flat face  83  has been turned to allow for the passage of waste material from the vessel (not shown) and subsequent cleaning of the apparatus and vessel. Housing  1  also provides a ridge  11  as well as flanges  41  and  43 . Flange  43  has two additional locking tabs  55 ,  57  to orient housing  1 . Turning now to the inside of the device, housing  1  expands to allow for insertion of closing member  71 . Inside housing  1 , threaded grooves  49  provide for insertion and tightening of closing member seating ring  151  and abut orienting feature  173 . 
       FIG. 11  is a top elevated perspective section view of the assembled apparatus  301  with alternate embodiment of closing member  372  intermediately between an open and closed position. The irrigation cleaning chamber  163  is more accessible to cleaning and irrigation fluids when in this position. It needs to be appreciated that apparatus  301  is designed to interface with a rotational mechanism (not shown) which can, in a specifically controlled frequency and arc, direct a stream of cleaning fluid in a desired manner based on the orientation of closing member  372 . Dynamically opening and closing the member allows access to the irrigation chamber to thoroughly clean all surfaces of closing member  372  and the interior of housing  1 . This automated rotation can take place in a sealed path connection with a disposal station allowing thorough cleaning via jet spray and not allow overspill of contained materials (not shown) to reach the outside environment. Moreover, this orientation can also direct the spray of cleaning fluid to specific locations on an attached waste vessel (not shown) when attached. 
       FIG. 12  is a plan view of the assembled apparatus when it is in the ‘open’ position. 
       FIG. 11  shows housing  1  assembled with closing member  71  and closing member handle  93 . The external surface of closing member handle  93  is made up of handle  95  connected to handle face  97  with handle face raised feature  99 . From this view locking tab open stop  133  and locking tab closed stop  135  can be seen. Locking tab closed stop  135  automatically secures button  121  and prevents motion of the closing member  71  until button  121  is physically depressed, and prevents rotation beyond a specified angle, as well as preventing rotation from the closed position unless button  121  is depressed. 
       FIG. 13  is a side view of the assembled apparatus  301  connected to waste vessel  321  containing medical waste  406  incorporated into a fully ‘smart’ or controlled gateway waste disposal system incorporated with controller  305  and motor  307 . Assembled apparatus  301  in conjunction with vessel  321  links sink  302  with sewer line  304 . Sensors  306 ,  308  and  310  sense signals from transmitters  320  and  412 . The signals or the absence thereof is communicated to control mechanism  305  which operates motor  307 , cleaning water source  401 , cleaning and disinfectant solution source  407  in conjunction with user interface  403 . Sensors and transmitters  306 ,  308 ,  310 ,  320  and  412  can be magnetic, radio frequency devices or purely mechanical. In a Radio Frequency embodiment sensors and transmitters  306 ,  308 ,  310 ,  320  and  412  can provide and optionally store device specific information such as device cycle count or estimated cycles available before replacement. When closing member  71  is turned by motor  307  into the ‘closed’ position as depicted, waste materials will not flow to sewer output  304 , but when closing member  71  is rotated into the open position cleaning fluid from cleaning fluid reservoir  407  can be dispensed by cleaning pipe  311  and clean the internal components of apparatus  301  in conjunction with vessel  321  but is prevented from escaping because of the internal sealing at  420 . Drainage of biological waste  406  or cleaning fluid (not shown) is facilitated through vent (not shown). Vent (not shown) can be boosted by way of vacuum assistance. Ingress of cleaning fluid (not shown) or egress of waste material  406  is controlled by controller  305 , which controls cleaning time, cleaning fluid amount and cycling of closing member  71 . Based on varying each of these factors, controller  305  can regulate the position of cleaning fluid both within apparatus  301  as well as waste vessel  321  due to specific orientation of closing member  71 . Transmitter  320  on waste vessel  321  relays its characteristics to controller  305  to identify the contents of waste vessel as well as other information including vessel use cycle count. Based on the identity of sensor  320  on waste vessel  321 , controller  305  varies cleaning parameters such as wash time, cleaning fluid amount and number of times to cycle closing member  71  open and closed to facilitate cleaning. Since the type and consistency of contents of waste vessel  321  is identified by the particular type of transmitter  320  detected by controller  305  cleaning times can be made longer or shorter, or vary the specific type of cleaning fluid (not shown) as called for by controller  305 . In addition, a use cycle count is also made which can prevent subsequent use of vessel  321  if it has exceeded a preprogrammed standard value. During cleaning, waste vessel  321  is inserted into apparatus  301  by inversion, but contents of vessel  301  are contained due to the presence of locking cap  371  which prevents egress of contents until waste vessel  321  is fully seated into apparatus  301  by rotation, causing closing member  71  to open. Proper seating is confirmed to the user through tactile feedback which occurs when insertion rotation is complete. Once closing member  71  is opened, contents of waste vessel  321  are emptied and waste vessel  321  is then cleaned while preventing spillage or undesired discharge of the contents of waste vessel  321  anywhere but through the internal surface of valve manifold housing assembly  410 . In a foreseen variant of locking cap  371 , locking cap  371  can only be intentionally locked or unlocked via a corresponding locking element. 
     The physical conformation of waste vessel  321  is specifically designed to prevent pooling or retention of contaminated waste matter. In a foreseen variant, the estimated life cycle of apparatus  301  can be calculated by controller  305  and varied based upon the different types of waste material encountered as identified by transmitter  320 . Apparatus  301  can also be operated with stopper (not shown) which contains sensor (not shown) which prevents communication between the sink  302  and the sewer channel  304 . This apparatus allows the sink to be used in its normal function and will permit the operator, via the user interface, to clean and disinfect the cleaning and sewer channel  304 . It is understood that connections between controller  305  and sensors and transmitters  306 ,  308 ,  310 ,  320  and  412  could be wireless as well as wired. 
     Controller  305  incorporates CPU  501 , and memory  503  which allow for automated cleaning functions to take place based upon input from sensor  320 . Automated cleaning routines include the ability to target the spray of cleaning fluid based upon the orientation of closing member  71 . Cleaning routines can be proportionally varied based upon the age of the vessel and content type as well as by vessel color if an optical sensor to optically detect vessel color properties is integrated into the system. 
     Cleaning controlled by controller  305  can vary wash functions (or prevent wash functions on devices which have exhausted their product cycle) based on wash time, rinse time, quantity of cleaning fluid, and allow for the incorporation of cleaning protocol standards should they become required by government entities such as the FDA. 
     Memory  503  can also retain information regarding specific vessels based upon input from sensors and transmitters  306 ,  308 ,  310 ,  320  and  412 . This information includes type of vessel, number of times a particular vessel has been cleaned, and parameters for cleaning maximums. In one embodiment, the vessel cleaning maximum is not only a function of the number of times a vessel has been cleaned, but also calculates a ‘wear’ component. An example of this would be if a vessel was only ‘cold sterilized’ for one type of contents then ‘hot sterilized’ to account for another type of contents, the overall calculated lifespan of the vessel could be reduced to account for the greater ‘wear and tear’ of the heat sterilization. 
     While the described system and method incorporates data transfer between vessels and the waste receptacle system, data transfer may alternately take place by way of remote sensors (not shown) reading vessel  321  properties which have not been docked with apparatus  301 . 
     The term ‘stiction’ follows the common definition of a generally undesirable trait. Sticktion is often caused by pressure in combination with metal to metal contact. Because metal is porous, when the metal is dry or the pressure exceeds the capacity of the lubricant, two pieces of metal occupy the same space causing “stoppage” and “sticking”. As force increases, the sticking breaks until it sticks again. Both inconvenience, as well as metal wear are the result. 
     While the disclosed apparatus is illustrated by description of several embodiments and while the illustrative embodiments are described in detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications within the scope of the appended claims will readily appear to those sufficed in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicants&#39; general concept.