Abstract:
A device and method for use in taking a sample from an item of medical equipment for the purpose of microbiological testing. The device includes attachment mechanism for attaching about a region of the item of medical equipment in an air-tight manner; and collection mechanism for collecting fluid which emanates from the item of medical equipment.

Description:
[0001]    This application is a National Stage completion of PCT/AU2012/000013 filed Jan. 11, 2012, which claims priority from Australian patent application serial no. 2011900078 filed Jan. 12, 2011. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to devices for, and methods of, taking samples from medical equipment for the purpose of microbiological testing. The invention has particular application to taking samples from endoscopes and dialysis machines but is not limited to those uses. 
       BACKGROUND TO THE INVENTION 
       [0003]    An endoscope is an instrument used to examine the interior of a hollow organ or cavity of the body. They are most typically used to make inspections of the gastrointestinal tract, or the respiratory tract. 
         [0004]    Following each use on a patient, the endoscope must be cleaned and reprocessed to achieve the recommended standard of sterilization or high level disinfection to reduce the risk of cross-infection of subsequent patients. Following reprocessing the scopes are to be stored in a manner applicable to the standard of sterilization or high level disinfection, the endoscope is wrapped in a protective wrapper or stored in a suitable scope cabinet ready for the next use. 
         [0005]    In order to ensure that endoscopes are being properly sterilized, a microbiological surveillance regimen is typically adhered to. This involves routine testing of endoscopes at fixed time intervals, such as every 4 to 12 weeks. The endoscopes are tested by obtaining a sample from the endoscope channels, the sample is then cultured and analyzed for the presence of bacteria. 
         [0006]    The sample is usually obtained using sterile water, a sterile container, and an endoscope brush in the following manner:
       Sterile water is flushed into each of the channels to be brushed, and any water which emerges from the distal tip is collected.   The brush is inserted into the biopsy channel of the endoscope, withdrawn and swirled in the water in the sterile container   Remaining brushable channels such as the suction channel of the endoscope are brushed and brush swirled in collection device again.   Using a sterile syringe, sterile water is flushed under positive pressure through each of the channels in turn. Flushing is performed from the connection points in the light guide plug and flow to the distal tip. Fluid is flushed until it emerges from the tip.   Air is then syringed through to empty the remaining fluid from each of the channels. The total rinse fluid is collected in the sterile container.   The container is sealed, labeled, and sent for testing.       
 
         [0013]    Throughout the sampling procedure, attention must be paid to preventing the tip of the endoscope from touching the container so as to avoid contamination. Furthermore, the body of the endoscope must be kept in a raised position with respect to its distal end to ensure that fluid flows in the intended direction, towards and out of the distal end. This means that the sampling procedure must be carried out by a team of two people. One person stands at a raised position, such as by standing on a chair, and introduces the sterile water. The second person holds the distal end of the endoscope at the mouth of the sterile container to collect water emanating from the tip of the endoscope. 
         [0014]    Furthermore, the mouth of the sterile container is open to the air during the sampling procedure, which gives rise to a risk of false positive test results, which in turn necessitate a repeated and unnecessary test of the same endoscope. 
         [0015]    Similar issues are experienced in sampling procedures carried out other types of medical equipment, such as dialysis machines. 
         [0016]    There remains a need for improvements in procedures for obtaining samples from medical equipment. 
       SUMMARY OF THE INVENTION 
       [0017]    In a first aspect the present invention provides a device for use in taking a sample from an item of medical equipment for the purpose of microbiological testing including: attachment means for attaching about a region of the item of medical equipment in an air-tight manner; and collection means for collecting fluid which emanates from the item of medical equipment. 
         [0018]    The device may further include a suction means for sucking air from the collection means, to thereby draw fluid from the item of medical equipment. 
         [0019]    The suction means may be provided in the form of a cylinder and plunger arrangement. 
         [0020]    The cylinder and plunger may be embodied in a sterile syringe. 
         [0021]    The suction means may include a pair of one way valves which allow for reciprocation of the cylinder and plunger arrangement. 
         [0022]    The device may further include an aperture for allowing the introduction of a brush in to the collection means. 
         [0023]    The attachment means may include a resilient portion which forms an air-tight seal with the item of medical equipment. 
         [0024]    The attachment means may further include prongs which space the item of medical equipment away from internal surfaces of the device. 
         [0025]    In a second aspect the present invention provides a method of collecting a sample from an item of medical equipment for the purpose of microbiological testing including the steps of: attaching a reservoir of sterile fluid to one end of a channel of the item of medical equipment; attaching a collecting means about the second end of the channel in an air-tight manner; passing fluid through the channel of the item of medical equipment; and collecting fluid which emanates from the channel. 
         [0026]    The fluid may be caused to pass through the channel by way of withdrawing air from the collection means. 
         [0027]    The air may be withdrawn manually by way of a cylinder and plunger arrangement. 
         [0028]    The cylinder and plunger arrangement may be provided in the form of a syringe. 
         [0029]    The method may further include the step of brushing the channel. 
         [0030]    The method may further include the step of placing a portion of the brush into the collection means and sealing the collection means with the portion of the brush inside. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0031]    An embodiment of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: 
           [0032]      FIG. 1  is a perspective view of the connector section of a typical endoscope; 
           [0033]      FIG. 2  is a perspective view of the control section of the endoscope of  FIG. 1 ; 
           [0034]      FIG. 3  shows apparatus according to an embodiment of the present invention; and 
           [0035]      FIG. 4  shows additional apparatus according to an embodiment the present invention; 
           [0036]      FIG. 5  is a side view of apparatus according to alternative embodiment of the invention; 
           [0037]      FIG. 6  is a top view of the apparatus of  FIG. 5 ; 
           [0038]      FIG. 7  is a cross-sectional view along the line A-A of  FIG. 6 ; 
           [0039]      FIG. 8  is an enlarged view of detail A of  FIG. 7 ; and 
           [0040]      FIG. 9  is a cross-sectional view along the line B-B of  FIG. 6 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0041]    Embodiments of the invention will now be described with reference to taking samples from an endoscope. 
         [0042]    Referring to  FIGS. 1 and 2 , an endoscope of typical construction is shown comprised of a connector section (see  FIG. 1 ) and a control section (see  FIG. 2 ) which are joined by a universal cord  10 . The working length  30  is shown of truncated length in  FIG. 2  for ease of illustration. Endoscope comprises the following usual features labeled by number as follows: 
         [0043]      1 . Suction connector 
         [0044]      2 . S-cord connector mount 
         [0045]      3 . Air supply connector 
         [0046]      4 . Water supply connector 
         [0047]      5 . Electrical connector 
         [0048]      6 . Air pipe 
         [0049]      7 . Light guide 
         [0050]      8 . Product name and serial number 
         [0051]      9 . Electrical contacts 
         [0052]      10 . Universal cord 
         [0053]      11 . Auxiliary water inlet 
         [0054]      11 A. Auxiliary water inlet cap 
         [0055]      12 . UP/DOWN angulation control knob 
         [0056]      14 . UP/DOWN angulation lock 
         [0057]      16 . Suction valve 
         [0058]      18 . Air/water valve 
         [0059]      20 . Suction cylinder 
         [0060]      22 . Air/water cylinder 
         [0061]      24 . Biopsy valve 
         [0062]      26 . Instrument channel port 
         [0063]      28 . Insertion tube limit mark 
         [0064]      30 . Working length 
         [0065]      32 . Distal end 
         [0066]      34 . Bending section 
         [0067]      36 . Insertion tube 
         [0068]      38 . Boot 
         [0069]      40 . Color code 
         [0070]      42 . Grip section 
         [0071]      44 . RIGHT/LEFT angulation lock 
         [0072]      46 . RIGHT/LEFT angulation control knob 
         [0073]    Referring to  FIGS. 3 and 4 , apparatus is shown for use in taking samples from an endoscope such as the one shown in  FIGS. 1 and 2 . Referring to  FIG. 3 , a sterile water supply arrangement  40  is shown including a branched tubular arrangement with suction channel connection  41 , air/water connection  43  and auxiliary water channel connection  45 , each with associated stopcocks  42 ,  44  and  46  for controlling the flow of water through each of the pipe branches. Jar  47  holds a supply of sterile water  48  which is drawn from jar  47  by way of downpipe  49 . 
         [0074]    Referring to  FIG. 4 , a device  50  for use in taking samples from endoscopes is shown including attachment means in the form of insertion attachment  60  for attaching in an air-tight manner to distal end  32  of the endoscope by way of interference fit of the distal end  32  into membrane  62  which is provided with a central aperture. Device  50  further includes collection means in the form of sample container  58  and lid assembly  52 . A suction means in the form of a piston and cylinder arrangement is provided by sterile syringe  70 . Protective caps (shown in removed position)  57 ,  56  are used to seal channels  51 ,  59  which are provided in lid assembly  52 . Insertion attachment  60  fits to one end of channel  51 , syringe  70  fits to one end of channel  59 . The other ends of the channels open at the underside of lid assembly  52 . Channel  59  is fitted with two one-way valves  53 ,  54 . Valve  53  permits flow of air in the direction out of sample container  58 , but prevents flow of air into the sample container. Similarly, valve  54  permits air to flow in a direction out to the atmosphere, but prevents ingress of air into channel  59  from the atmosphere. When the plunger of syringe  70  is reciprocated back and forth, then the valve arrangement gives rise to a partial vacuum inside sample container  58 . This partial vacuum acts to draw sterile water from the jar  47 , through one of the channels of the endoscope, and into sample container  58  as will be later described. 
         [0075]    Brush aperture seal  55  allows an item, such as the tip of a brush, to be introduced into container  58  by removing and replacing the seal  55 . 
         [0076]    In order to take a sample from an endoscope, the following steps are carried out: 
         [0077]    1. Lay the endoscope on a bench or other surface. 
         [0078]    2. Attach suction channel connection  41  to suction connector  1 . 
         [0079]    3. Attach air/water connection  43  to air pipe  6   
         [0080]    4. Attach auxiliary water channel connector  45  to auxiliary water inlet  11   
         [0081]    5. Put in place an air/water bridge connecting air supply connector  3  with water supply connector  4 . Put in place suction valve  8 , air/water valve  18 , and biopsy valve  24   
         [0082]    6. Ensure that all of stopcocks  42 ,  44  and  46  are in their closed positions. 
         [0083]    7. Fit insertion attachment  62  and syringe  70  to lid assembly  52  and fit sample container  58 . Push fit distal end  32  of endoscope into insertion attachment  62 . 
         [0084]    8. Open stop cock  42 . Reciprocate the plunger of syringe  70  to draw sterile water through the biopsy channel. Continue until approx 10 ml to 100 ml of water has emanated from distal tip  32  to be collected in container  58 . Close stop cock  42 . 
         [0085]    9. Open stop cock  44 . Reciprocate the plunger of syringe  70  to draw sterile water through the air/water channel. Continue until approx 10 ml of water has emanated from distal tip  32  to be collected in container  58 . Close stop cock  44 . 
         [0086]    10. Open stop cock  46 . Reciprocate the plunger of syringe  70  to draw sterile water through the auxiliary water channel. Continue until approx 10 ml of water has emanated from distal tip  32  to be collected in container  58 . Close stop cock  46 . 
         [0087]    11. Remove insertion attachment  62  and syringe  70  from lid assembly. Re-seal channels  51 ,  59  with caps  57 ,  56 . 
         [0088]    12. Remove all channel blockers and accessories from the endoscope. Using the disposable sterile brush supplied, brush the biopsy and the suction channels. 
         [0089]    13. Collect the brush sample by removing seal  55 , insert the tip of brush into the sample container  58  and cut off the tip of the brush to leave the tip of the brush inside container  58 . Replace seal  55 . 
         [0090]    14. Label sample container  58  and send away for testing. 
         [0091]    Referring to  FIGS. 5 to 9 , an alternative embodiment of apparatus is shown which operates along the same principles as the embodiment described above, but has various structural differences. Like reference numerals have been used to indicate with like functions to the first described embodiment. 
         [0092]    Device  150  includes an insertion attachment  160 , a sample container  158  and a lid assembly  152 . Lid assembly  152  clips to sample container  158  in an airtight manner. 
         [0093]    The insertion attachment  160  is best seen at  FIG. 8  and is formed from three components being plug  165 , a circular silicone membrane  162  and insert  163 . Insert  163  is a snap fit inside plug  165  and the membrane is retained about its periphery by being trapped between plug  165  and insert  163 . The insertion attachment  160  is a push fit into lid assembly  152 . Membrane includes a central aperture  168 . When a region of an item of medical equipment, such as the end of an endoscope, is inserted into insertion attachment  160  and through aperture  168 , the silicone membrane expands to fit about the medical equipment to form an air-tight seal. An arrangement of four prongs  164  serves to support the medical equipment that is inserted and to space it away from the inside surfaces of the device  150  to prevent contamination of the sample. Alternative inserts having more closely spaced, or widely spaced prongs, may be provided to accommodate items of medical equipment of various sizes. 
         [0094]    The device  150  supports the end of the item of medical equipment introduced into it at an angle of approximately  45  degrees to the surface upon which device  150  is resting. 
         [0095]    An air withdrawal port  170  is provided on lid assembly  152  to which is fitted a tube which connects to a suction device, such as one similar to the syringe and double-valve arrangement described in the first embodiment. By withdrawing air from port  170 , a partial vacuum is created inside device  150  which serves to draw fluid through a channel in the medical equipment. 
         [0096]    Another sealable port  155  is provided so that the tip of a brush may be introduced into deice  150  in a similar fashion as that described above. 
         [0097]    Except for the silicone membrane, all parts of device  150  are formed from ABS plastic. 
         [0098]    When the sampling procedure is complete, the insertion attachment  160  is removed and replaced by a stopper. The device  150  containing the sample is then ready to be sent away to a laboratory for microbial testing. 
         [0099]    It can be seen that embodiments of the invention have at least one of the following advantages:
       The procedure of taking a sample from the endoscope can be carried out by one person.   The procedure for taking a sample from the endoscope may be carried out with the endoscope laid out on a worktop. There is no need to maintain the body of the endoscope at a raised height.   The sample collecting container is sealed from the atmosphere during sample collection, thereby reducing risk of false positive readings due to airborne contaminants.   The sample is drawn by manual operation of a syringe, thus allowing accurate control over the sampling procedure.   Procedure involves destruction of a disposable brush, thus reducing false positives arising from reuse of brushes.   A sterile brush is supplied with each collection kit to further reduce the risk of false positive test results.       
 
         [0106]    Whilst the embodiments above were described with reference to taking samples from an endoscope, they could similarly be used with other items of medical equipment which have channels through which fluid may be passed such as dialysis machines and the like. 
         [0107]    Whilst the embodiment described above utilized a syringe to provide suction, in other embodiments an electrically powered suction pump could be used instead. 
         [0108]    Any reference to prior art contained herein is not to be taken as an admission that the information is common general knowledge, unless otherwise indicated. 
         [0109]    Finally, it is to be appreciated that various alterations or additions may be made to the parts previously described without departing from the spirit or ambit of the present invention.