Abstract:
A container provides for soaking medical instruments. The container includes a basin for receiving one or more medical instruments, a fill level sensor for detecting presence of a soaking substance at a minimum fill level, a lid closure sensor which detects closure of a lid onto the basin, and a timer adapted to begin a timing sequence when both the fill lever sensor detects presence of the soaking substance at the minimum fill level and the lid closure sensor detects closure of the lid. Proper soaking of the instruments prior to a full cleaning procedure improves the reliability of the cleaning procedure.

Description:
FIELD OF THE INVENTION 
       [0001]    This application relates to preparing medical instruments for reuse after a medical procedure, and more specifically to insuring that the instruments receive a sufficient amount of time in a soaking solution after their medical use. 
       BACKGROUND OF THE INVENTION 
       [0002]    Many medical instruments are designed to be reused after a particular procedure. However, after having come into contact with bodily fluids and material, deposits can form on these instruments, which are difficult to remove in a clean procedure. It is recommended that instruments be soaked for a time period prior to their being cleaned and sterilized. 
         [0003]    Insuring that a sufficient soaking period is achieved while achieving rapid turnaround in the time from use of the instrument in a surgical procedure until it is ready for reuse can be a challenge. In some instances, the personnel who put the instruments into a container for soaking differ from the personnel who may remove the instrument from that container, and the removal may occur in a physically distant location in the medical setting. For instance, nurses in an operating room may put the instruments in for their initial soaking, and later personnel in the central supply room of the hospital where the subsequent cleaning and sterilization is to occur may remove them from the soaking solution. Effective communication is required to insure that a sufficient time for soaking has occurred without delaying processing of the instruments after such sufficient time has actually occurred. It is also important to make sure that a sufficient depth of soaking solution is achieved in the container so that all portions of the instrument remain submerged. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention overcomes these and other limitations in the prior art 
         [0005]    A container, according to the present invention, provides for soaking medical instruments. The container includes a basin for receiving one or more medical instruments, a fill level sensor for detecting presence of a soaking substance at a minimum fill level, a lid closure sensor which detects closure of a lid onto the basin, and a timer adapted to begin a timing sequence when both the fill lever sensor detects presence of the soaking substance at the minimum fill level and the lid closure sensor detects closure of the lid. Proper soaking of the instruments prior to a full cleaning procedure improves the reliability of the cleaning procedure. 
         [0006]    Preferably, the container incorporates a screen at or below the minimum fill level to enforce submersion of buoyant instruments. Conveniently, this would attach to the lid. 
         [0007]    Preferably, instructions are included for loading one or more instruments into the container, filling the container to at least the minimum fill level, closing the lid and allowing the instruments to soak for a time period timed by the timer. 
         [0008]    Preferably, an indicator on the container indicates a successful soaking cycle after the timer has run for a predetermined time period. 
         [0009]    Preferably, a communication system is provided for communicating data between the container and an external monitoring or control system, which could be either local, such as a handheld device used at the container or remote, such as a host computer located in a different part of the building, or even perhaps accessed over the internet at a location geographically removed from where the container is located. 
         [0010]    Preferably, the soaking substance incorporates a cleaning fluid, a disinfectant or a sterilant. Hydrogen peroxide is preferred for its ability to dissolve dried blood and to quickly inactivate common pathogens of concern to hospital personnel. Preferably it is present in the soaking substance from 3% to 10% by weight, and more preferably from 4% to 6% by weight. 
         [0011]    A method, according to the present invention, provides for ensuring proper soaking of instruments. The method comprising the steps of: a) placing one or more instruments into a basin of a container; b) filling the container to a minimum fill level with a soaking substance and detecting such via a minimum fill sensor; c) closing the container with a lid and detecting such via a lid closure sensor; and d) upon completion of both steps c) and d), initiating a timer cycle to time soaking of the instruments. 
         [0012]    Preferably, successful completion of a soaking cycle comprises the lid remaining closed and the level of soaking substance remaining at or above the minimum fill line during a predetermined time, and the method further includes the step of displaying the successful completion of the soaking cycle to the user. The time preferably exceeds 5 minutes. 
         [0013]    In one aspect of the invention the soaking substance comprises a foam. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0014]      FIG. 1  is a front elevation view of a container of the present invention; 
           [0015]      FIG. 2  is a block diagram of a communication system for use with the container of  FIG. 1 ; and 
           [0016]      FIG. 3  is a block diagram of a handheld device for use with the container of  FIG. 1  and communication system of  FIG. 2 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]      FIG. 1  discloses a container  10  adapted for soaking medical instruments  12  after their use in a medical procedure. It comprises a basin  14  and a lid  16  which fits upon the basin  14 . The basin  14  is preferably fluid tight and sized to accommodate one or more of the surgical instruments  12  and to accommodate a soaking solution  18  up to a fill line  20 . Preferably, the lid  16  is also fluid tight and tightly fitting such that when the lid  16  is placed upon the basin  14  the container  10  becomes fluid tight such that the solution  18  cannot easily spill out. 
         [0018]    A soaking indicator system  22  on the container  10  aids in determining whether sufficient soaking time has been provided to the instruments  12 . This system  22  comprises in gross a fill sensor  24  at the fill line  20  to detect the proper depth of solution  18 , a lid closure sensor  26  to detect proper closure of the lid  16 , and a data logger  28  having a timing function to time the lid  16  being closed with solution  18  to the fill line  20 . In simple form, the soaking indicator system  22  employs a moisture sensor for the fill sensor  24 , a contact switch for the lid closure sensor  26  and a simple countdown timer for the data logger which initiates its timing upon activation of the fill sensor  24  and lid closure sensor  26  and then provides an indication at the end of a predetermined soaking time such as by lighting an LED  27 . For instance a red LED could indicate that the cycle is not yet complete and a greed LED could indicate that the cycle is complete, preferably with labels for each LED. Of course, more sophisticated systems may also be employed. 
         [0019]    One important feature of the lid  16  is a screen  30  which is disposed below the lid  16  and sits at or below the fill line  20  when the lid  16  is closed. The screen  30  insures that buoyant instruments  12  will not float up above the level of the solution  18  and have certain portions of themselves avoid proper soaking. Preferably, it is supported on standoffs  32 . For economy and construction, one of the standoffs  32  can be adapted to engage the lid closure sensor  26 . Further, the standoffs  32  may bear a seal  34 , as for instance silicone, which bears against the container  16  and helps to maintain leak-tight configuration when the lid  16  is closed. The seal  34  could be located on other locations of the lid  16  or where the lid  16  contacts the basin  14 . One or more latches, not shown, may be provided for holding the lid  16  closed. 
         [0020]    A more sophisticated data logger  40  is shown in  FIG. 2 . The data logger  40  mounts on the wall of the soaking container  10  and incorporates the fill sensor  22  and the lid closure sensor  26  each of which are connected in series to a controller  42 . 
         [0021]    The controller  42  receives a high input signal only when both the lid closure  26  and liquid fill  22  sensors are closed. A high input signal to the controller  42  starts a soaking timer within the controller  42 . Preferably the status of the sensors  22  and  26  and other information such as the soaking duration are displayed on a display  44 , such as an LED or LCD display. The display  44  can also include a count down timer output showing the time remaining until a full soaking has been completed. Preferably it further provides some indication at to whether there is enough liquid and whether the lid is closed properly. During soaking time if either the lid is opened or the liquid level falls below the minimum fill line, the timer will reset. Satisfactory completion of a soaking cycle is displayed on the display  44 . 
         [0022]    Further, information regarding the soaking cycle is transferred to a remote base station host  46  for further processing. Such information can include the soaking time, time of completion etc. Transfer of the information to the host  46  can occur in a multitude of ways, such as through a USB link  48 , RF transceiver  50 , RFID (not shown) or manual entry. 
         [0023]    If using the RF transceiver  50  to communicate with base station and an optional hand held device  52  ( FIG. 3 ), communication is controlled through a range controller  54  by adjusting communication frequency and/or power. The data logger controller  42  encodes and transmits data through its RF transceiver  50  using an antenna  56 . Similar equipment at the base station  46  and handheld device  52  receive the signal from the antenna  56  and decode the data. Preferably, the data logger communicates with the base station  46  and hand held device  52  through high frequency and low frequency RF, respectively and the base station  46  communicates with the hand held device  52  through low frequency RF communication. 
         [0024]    The data transferred can include a unique container identifier, soak time, user information, instrument list, fluid level, fluid type, lid status, record of container usage, instruments, record of instrument usage, and record of instrument processing methods including cleaning, disinfection or sterilization. The information can be communicated visually or electronically, locally or remotely. By viewing or retrieving the information, user can know whether the container has enough fluid, what type of fluid is in the container, whether the lid is closed properly, whether the instrument has been soaked long enough, the owner of the container, the history of the container, instrument in the container, the number of instruments, the history of the instrument, and the next processing step after soaking. The next step can be for further cleaning, decontamination, disinfection, or sterilization. The decontamination, disinfection or sterilization can be either low temperature or higher temperature process. It can also be a specific washer, decontaminator, or washer/decontaminator. 
         [0025]    When the amount of information is small the display  44  should suffice. When more copious amounts of information are handled the handheld device  52  is preferred. It ideally communicates directly with the container&#39;s transceiver  50 . Existing communication protocols such as Bluetooth or WiFi are preferred, but the invention need not be so limited. 
         [0026]    Information about the instruments  12 , such as the type, number and ID numbers thereof can be manually entered, either on a keypad or entry device on the container  10 , but more preferably through the handheld device  52 . A more convenient method would be to tag each instrument  12  with a machine readable tag, such as an RFID tag  60  ( FIG. 1 ). Then, an RFID tag reader  62  incorporated into the data logger  40 , or in the handheld device  52  could read and record the information automatically. Therefore, the container  10  can communicate with the user whether all previously removed instruments are properly back to in the container  10 . Preferably, the display  44 , or the handheld device  52 , will indicate when all of the instruments  12  are in the container  10 , and if not which ones are missing. The user can also track the location of the container  10 , the use of the container  10 , and the use of instruments  12  in the container. The information can be delivered to the remote host  46  for processing and storage. Optionally, the host  46  can receive container information and then send necessary information to the handheld device  52  to notify user of the container status or information. 
         [0027]    Depending upon the types of instrument  12  or perhaps even the type of procedure in which it was used, the length of time for soaking can be modified. The type or strength of soaking solution may also be adapted. Preferably, this is automatically determined by the onboard controller  42 , or by the handheld device  52  or the remote host  46  and then communicated to the onboard controller  42 . If a change in soaking fluid is involved it is preferably communicated to a user by being displayed on the display  44  or on the handheld device  52 . 
         [0028]    In use, one or more instruments  12  are placed into the basin  14 . Typically they are placed in the basin  14  as their use in a surgical or other medical procedure is completed. The soaking solution  18  is then placed over the instruments. The solution  18  may not be topped up to the minimal fill line  20  until all the instruments  12  are in the basin  14 . When the solution  18  reaches the minimum fill line  20  the fill sensor  24  detects this and closes. After all the instruments  12  are in the basin  14  and sufficient solution  18  has been added to reach the minimum fill line  20 , then the lid  16  is closed. Closure of the lid closes the lid closure sensor  26 . When both sensors  24  and  26  have closed the data logger timer begins to run. After running for a predetermined time an indication of completion is provided such as by lighting the LED  27 . 
         [0029]    Different soaking solutions  18  are appropriate for use with the present invention. It may be a cleaning fluid, a disinfectant, or a sterilant. Preferably, the fluid has combined features of cleaning/disinfection or cleaning/sterilization. One well known cleaning solution is ENZOL enzymatic soaking solution available from Advanced Sterilization Products division of Ethicon, Inc. located in Irvine, Calif. Alternatively, a solution of hydrogen peroxide (preferably 3 to 10% by weight, more preferably 4 to 6%) can be employed. A further option would be so employ a foam, such as a foam comprised of hydrogen peroxide, preferably incorporating a corrosion inhibitor and a lipid dissolving agent. A foam has the advantage of having less mass easing handling of the filled container and reducing the chances of spillage. A suitable foam is disclosed in co-pending U.S. application Ser. No. 11/565,126, filed Nov. 30, 2006, the contents of which are incorporated herein by reference. 
         [0030]    The minimum soaking time depends upon the goal sought. For soaking in the 6% peroxide foam five minutes is sufficient to dissolve dried blood, and for a 3% foam ten minutes. Such soaking times are also sufficient to inactivate most common pathogens of concern to hospital personnel. 
         [0031]    The foam volume may decrease over time. Therefore, container with foam may have an automated triggering mechanism to regenerate foam in the container to the required level. The mechanism may be an agitator on the slopped bottom of the container. The agitator may be driven by a motor and a power source. Alternatively, air can be pumped through the foam. The triggering mechanism may be a timer or a fluid level sensor. 
         [0032]    The invention has been described with reference to the preferred embodiments. Obviously, modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.