Abstract:
A device and method for cleaning and sterilizing a bronchoscope. A caddy is provided for containing the bronchoscope prior to, during, and subsequent to cleaning and disinfection of the bronchoscope. The caddy may be used to transport the sterilized bronchoscope from the cleaning area to an operating suite, while maintaining the bronchoscope in a cleaned and disinfected state.

Description:
[0001]    The contents of Provisional Application Ser. No. 61/691,471 filed Aug. 21, 2012, on which the present application is based and benefit claimed under 35 U.S.C. §119(e), is herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention pertains to medical devices and methods generally, and is more specifically directed to a cleaning device method, and a caddy for a bronchoscope. 
       BACKGROUND OF THE INVENTION 
       [0003]    Bronchoscopy is a technique of visualizing the inside of the airways for diagnostic and therapeutic purposes. A bronchoscope is inserted into the airways, usually through the nose or mouth, or occasionally through an endotracheal or tracheostomy tube. Using the bronchoscope, the operator visually examines the patient&#39;s airways for abnormalities such as foreign bodies, bleeding, tumors, or inflammation. Specimens may be taken from inside the lungs. The bronchoscope may comprise optical fiber instruments with real time video equipment. An exemplary bronchoscope is shown in  FIG. 1 . 
         [0004]    Bronchoscopes of the type shown in  FIG. 1  are reusable. Accordingly, the bronchoscope must be properly disinfected and cleaned after use. There is a need for a device that will clean and disinfect or sterilize the bronchoscope in a substantially automated process. The device should also provide a means for containing and transporting the cleaned and disinfected or sterilized bronchoscope for reuse, with no direct handling of the bronchoscope during transport. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention is a device and method for cleaning and disinfecting a bronchoscope. A caddy is provided for containing the bronchoscope prior to, during, and subsequent to cleaning and disinfection of the bronchoscope. The caddy may be used to transport the disinfected/sterilized bronchoscope from the cleaning area to an operating suite or other procedure area, while maintaining the bronchoscope in a clean and disinfected state. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  is an exemplary bronchoscope of a type that may be used with the invention. 
           [0007]      FIG. 2  is a perspective view of an embodiment of a cleaning device for a bronchoscope. 
           [0008]      FIG. 3  is a perspective view of the cleaning and disinfecting device of  FIG. 2 , with a bronchoscope in position. 
           [0009]      FIG. 4  shows the cleaning and disinfecting device of  FIG. 3 , demonstrating the caddy containing the bronchoscope being removed from the cleaning device. 
           [0010]      FIG. 5  shows the caddy with a cleaned and disinfected bronchoscope contained therein, and capped at each end for transportation for use. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0011]      FIG. 1  shows a bronchoscope  2  of a type that may be used with the invention. The invention is not limited to use with the exact structure shown in  FIG. 1 . The bronchoscope as shown in  FIG. 1  has a soft rubber tube  4  that may be passed through the nose. The bronchoscope may be connected to a video and/or light source. A camera may be mounted to the top of the bronchoscope in the embodiment shown in  FIG. 1 . 
         [0012]    After use, according to an embodiment of the present invention, the bronchoscope is placed into a caddy  6 .  FIG. 2 . The caddy is preferred to have a relatively large opening  8  at the top for receiving the bronchoscope. The caddy has an opening in the top portion thereof for receiving and holding the bronchoscope. According to the embodiment shown in the drawings, the caddy may have a cylindrical top portion for receiving the bronchoscope. In another embodiment the top portion has one or more flat surfaces, while maintaining the volume necessary to house that portion of the bronchoscope. 
         [0013]    The caddy is shown in the drawings as being transparent for illustration purposes, but may be transparent, translucent or opaque in use. A transparent embodiment allows the device to be viewed while in the caddy for identification purposes, without violating the cleanliness of the device. 
         [0014]    In a preferred embodiment, in a lower region of the caddy is a lower tube  10  of substantially reduced dimension or diameter from the top portion, according to the embodiment shown in the drawing figures. The lower tube has a lumen therein that receives fluids from the upper portion. The lower tube has an opening at the bottom thereof to discharge fluids from the caddy. 
         [0015]    Between the upper cylindrical portion in the upper region of the caddy and the lower tube portion in the lower region of the caddy is a frusto-conical section  12  which both holds the lower end of the bronchoscope in position, and provides a funnel for channeling liquid and draining the caddy. The frusto-conical section of the caddy is in a mid-region of the caddy between the upper region and the lower region. The bronchoscope is held completely within the caddy as shown in  FIG. 4 , with the top of the bronchoscope positioned below the top edge of the caddy. 
         [0016]    The caddy and bronchoscope are positioned within the cleaning device. The cleaning device may be a cabinet  14 . The cabinet may be of any shape or configuration that will accept the caddy therein. The cabinet should be structured so as to hold the caddy. Holders, brackets or mounts suitable for holding the caddy in position may be provided. In a preferred embodiment, the caddy is held by a bracket of the cabinet so that the caddy is in a generally vertical position. The bronchoscope is positioned generally vertically within the caddy. 
         [0017]    In a preferred embodiment as shown in the drawing figures, the cleaning device has a conduit that branches into a plurality of connected conduits, each having an outlet. As shown in the drawing figures, there are three conduits branching from a main conduit  16 , each having outlets. More or fewer conduits may be used according to the particular application and the particular bronchoscope. 
         [0018]    The conduits may communicate with a rotary valve  18  to receive liquids and/or gasses for cleaning or drying the bronchoscope. A valve, such as the rotary valve, allows a selection between various materials that are forced under pressure through the valve and into conduits. The rotary valve may be manually operated to select between various materials, or the rotary valve may be motorized for selection between various materials, or the rotary valve may be motorized and operated by a timing circuit that switches the rotary valve in an automatic mode. Other types of valves and controls for valves may be used to selectively supply materials to the conduit on an automatic or semi-automatic basis. 
         [0019]    In one embodiment, the cabinet provides a seal  20  to seal the bottom orifice of the caddy, and selectively prevent or allow fluids to exit the caddy. The seal may be an air bladder that is inserted into the lower tube of the caddy, and the bladder inflated to seal the conduit when the caddy is filled with liquid material, and deflated to allow the caddy to drain as materials are placed into the caddy and the bronchoscope by the rotary valve. The seal may be actuated in a coordinated fashion with the rotary valve to cause the caddy to fill with liquid material and to drain the liquid material. A drain may be provided in the bottom of the cabinet for draining liquid material from the cabinet. 
         [0020]    In use, a bronchoscope that has been previously used in a medical procedure, and is in need of cleaning and disinfection, is placed into the caddy as shown in  FIG. 3 . Bronchoscopes of the type that are in common use have multiple ports  22 ,  24 . The conduits are conducted to the ports, as shown in  FIG. 3 . Accordingly, the ends of the conduit should have fittings on the ends that allow the ports of the bronchoscope to be connected to the conduits. One end of a conduit is shown as positioned in the caddy and below a top of the caddy. 
         [0021]    In an exemplary sequence, the seal is actuated to seal the bottom of the caddy and prevent draining of the caddy, such as by inflating an air bladder. The rotary valve is positioned to cause a cleaning and disinfecting fluid to flow under pressure into the caddy. The flow of material continues until the bronchoscope is completely submerged in the cleaning fluid that is present in the caddy. The cleaning fluid also flows into the interior of the bronchoscope under pressure, with the cleaning fluid flowing through the conduits into the ports of the bronchoscope. The cleaning fluid remains in the caddy for a sufficient time to clean and disinfect the bronchoscope. 
         [0022]    The seal is then released, such as by deflating the seal, to allow the fluid to flow from the outlet to the bottom of the caddy, and out of the cabinet. 
         [0023]    The seal is then actuated to seal the bottom orifice of the caddy. A liquid rinsing material is provided under pressure through a rotary valve and the conduits to also force the rinsing material through the conduits connected to the ports. The rinsing material fills the caddy so that the bronchoscope is substantially submerged. The rinsing material removes the first liquid disinfecting material from the bronchoscope and caddy, but may also further clean and disinfect the bronchoscope. The cleaning and disinfecting cycle, and/or the rinsing cycle, may be repeated as desired, or as is necessary to achieve cleaning and disinfection. 
         [0024]    After the bronchoscope is rinsed, the seal is actuated, such as by deflating the bladder, to allow the rinsing material to drain from the caddy and the cabinet. 
         [0025]    In one embodiment, after the rinsing material is drained from the caddy and the bronchoscope, the rotary valve is switched to communicate with a pressurized gas source. The pressurized gas source causes the gas to be forced into the caddy and through the ports of the bronchoscope under pressure, to expedite drying of the bronchoscope. The gas may be pressurized air. The cabinet may provide an elevated temperature to expedite drying, as long as the elevated temperature is not sufficiently high to damage the bronchoscope. Similarly, the pressurized gas may be of elevated temperature to expedite drying of the caddy and the bronchoscope. The cabinet may incorporate an exhaust fan and appropriate filters, such as HEPA filters, to reduce the discharge of noxious materials or odors for use in areas without sufficient air exchange. In a since it will have a self contained fume hood. The cabinet may provide temperature and/or volume and/or pressure monitoring devices to monitor the liquid materials and/or air in the chamber. 
         [0026]    After the bronchoscope is cleaned, disinfected, and preferably dried as described herein, the caddy is removed from the cleaning device. It is preferred that only the exterior of the caddy is touched as the caddy is removed, and that the bronchoscope is not touched. The interior of the caddy, as well as the bronchoscope, are cleaned and disinfected. 
         [0027]    Covers are provided for the caddy. A removable top cover such as end cap  26  covers the top opening of the caddy. A removable lower cover such as smaller end cap  28  covers the lower opening of the caddy. End caps  26 ,  28  for the upper opening and lower opening of the caddy may be fitted as shown in  FIG. 5 . 
         [0028]    The covers or end caps should also be cleaned and disinfected, so that the bronchoscope is maintained in a sufficiently sterile state until it is ready for use. The top cover and lower cover in a clinically sterile condition after sterilization of the bronchoscope. The top cover and lower cover may be formed of flexible plastic material that provides a snap fit, or the covers and the caddy may be threaded for attachment. The caps should fit so that air is not conveyed through the openings of the caddy when the caps are in position covering the openings of the caddy. The bronchoscope may be transported within the caddy, while maintaining the bronchoscope in a sufficiently disinfected/sterile state for use. 
         [0029]    Flow of cleaning materials through, in sequence, the valve, conduit, caddy and drain is such that the exposure of the atmosphere to cleaning materials is minimal. The connections of the conduit(s) to the caddy and the connections of the drain to the caddy should be fittings that do not leak, and the bronchoscope is maintained in a sealed space in the caddy that is not exposed to the environment during the cleaning process. The drain is preferred to carry used cleaning materials away from the cabinet in a manner that does not expose the cleaning materials to the atmosphere. Accordingly, there may be no need to provide filtration for the cabinet. However, in the event that residual material is deemed to be environmentally detrimental, a filtration system may communicate with the interior of the cabinet to filter air from the cabinet during and after the cleaning operation. The filtration system assists in drying the minimal amount of residual cleaning material while also removing the residual cleaning material from the air.