GB2499202A

GB2499202A - Microbiological testing system

Info

Publication number: GB2499202A
Application number: GB1202108.5A
Authority: GB
Inventors: John Anthony Kerry; Vivienne Jean Kear
Original assignee: Individual
Current assignee: Individual
Priority date: 2012-02-08
Filing date: 2012-02-08
Publication date: 2013-08-14
Anticipated expiration: 2032-02-08
Also published as: GB201202108D0; GB2499202B

Abstract

A biological testing system for identifying the presence of bacteria on equipment, specifically endoscopes, comprising an air distribution apparatus 10 to provide at least one air path 17 to allow air which has been exposed to the equipment to pass over a culture medium 32. The system is preferably used for the determination of bacteria on endoscopes within storage cabinets and consists of a cassette (20) housing the culture medium which is inserted into the test apparatus which is connected to the air flow channels.

Description

Microbiological Testing System

[0001] The present invention relates to a portable device for microbiological testing of medical endoscope storage cabinets and other such places where microbiological problems may exist. In particular, the present invention relates to a portable test apparatus for the detection of bacteria in the air flow of the irrigation channels of endoscope drying cabinets.

[0002] Flexible medical endoscopes are used for the internal examination of parts of the human or animal body. They can be produced in lengths ranging from 300-3000mm. They may have internal channels where air, water or accessories can be directed to facilitate examinations or carry out special surgical procedures.

[0003] Due to the invasive nature of the procedures it is necessary that these channels be thoroughly cleaned and disinfected prior to and after each use.

[0004] According to the United Kingdom Medical Devices Agency (MDA), endoscopes which are not dried and which are not used within three hours of the washing and disinfection process must be reprocessed before they can be used again (ref. MDA bulletin Decontamination of Endoscopes). After cleaning and disinfecting endoscopes can be stored in cabinets, which have a tightly controlled environment through integral high efficiency particulate air (HEPA) filtered air system. In addition filtered air is passed through each channel of the endoscope via specific connector sets to ensure that warm dry air is continually flushed through the channels which have the effect of desiccation on any adherent bacteria. Endoscopes can be stored in this way for up to 28 days and beyond and remain in a condition which permits instant use.

[0005] At present there is no simple method of testing the potential presence of bacteria in the air flow which passes through the internal channels of the endoscope.

[0006] The present invention solves the problems associated with detecting bacteria passing through the irrigation channels of endoscope drying cabinets.

1

[0007] According to the present invention biological testing system to identify the possible existence of bacteria present on equipment is characterised in that it includes an air distribution apparatus providing at least one air path to allow air which has been exposed to the equipment to uniformly pass over a culture medium. Ideally the system has multiple air paths over multiple test medium cultures.

[0008] It one arrangement the system additionally includes has an air flow meter in each air path to measure the air flow over the culture medium. The meter may also be used to regulate the air flow

[0009] Preferably the system additionally comprises a cassette which houses the culture medium. Usually, but not essentially the cassette has a hinged lid. One or more recesses may be provided in the cassette to receive plates containing the culture medium. Ideally each recess in the cassette has a silicone rubber layer to push the plates into contact with the lid when the lid of the cassette is closed.

[0010] In a preferred arrangement the cassette comprises a tray which is tray being mounted to slide to and fro between a first position and a second portion between a pair mounting blocks, the second position is being a position in which the culture medium may be exposed to an air path, and a first position in which the culture is not exposed to an air path. A hinged lid to the cassette may be arranged such that the edge of said lid interferes with the tray when in its first position to ensure that the lid is closed in said first position. The air distribution apparatus may have an engaging means, such as a lug, whereby the lid remains closed and the tray in the said first position until the engaging means is engaged with the cassette. Further when the lid is released it can swing up in front of any adjustment knob o the air flow meters to prevent them being adjusted when the lid of the cassette is open.

[0011] The lid may be mounted on a pair of lugs which have pins pivotally mounted in the mounting block, the pins pivoting in the mounting blocks when the tray moves from said first position to said second position.

[0012] In the preferred arrangement described when the tray is in the second position it is exposed to at least one air path. Furthermore each air path

2

preferably includes an inverted funnel mounted above the base of the air distribution apparatus with the cassette being arranged such that when the tray is in the second position the culture medium is in plates, a plate below each inverted funnel.

[0013] The system described above was specifically invented to test for the presence of bacteria present in endoscopes in cabinets such as drying cabinets which have a flow of air to promoted drying. But other applications can be considered. As such the air paths may be coupled to air passing through in the cabinet by one or more ducts.

[0014] The system can be easily transported from one site to another, avoiding the need for much duplicated fixed equipment each coupled permanently to one cabinet.

[0015] In particular the system may be connected in use to air passing through endoscope irrigation channels.

[0016] As an example only, one embodiment of the invention is shown in the accompanying drawings, in which:

[0017] Figure 1 shows a perspective side front view of apparatus according to the invention on endoscopes in a drying cabinet according to the invention without a cassette;

[0018] Figure 2 shows a perspective side rear view of the apparatus of figure 1 without a cassette;

[0019] Figure 3 shows a perspective view of the apparatus of figure 1 without a cassette and with its case removed;

[0020] Figure 4 shows a perspective view of a closed cassette for use in the apparatus of figures 1 to 3; and

[0021] Figure 5 shows a perspective view of the cassette of figure 4 with its lid lifted.

[0022] A test apparatus according to the invention consists of two parts, figl, 2, and 3 the air flow distribution apparatus 10 and fig 4 and 5 show the cassette system 20 for the test media.

[0023] The air flow distribution apparatus 10 shown in Fig 1, 2 and 3 is connected to an endoscope drying cabinet and comprises an outer casing 1 made from a metal, such as stainless steel or other suitable material for its front

3

11, back 12 and sides 13 and a polymer, such as polypropylene or other suitable material, for its top 14 and base 15. Inside the example shown there are four inverted funnels 4 suspended above the base 15 of the test apparatus A. The funnels 4 ensure that air flow passing over a test culture mounted in any open cassette 20 (figures 4 and 5) and placed on the base 15 is uniform thereby giving more accurate readings of the amount of bacteria in the air going through the irrigation channels of any endoscopes in the drying cabinet.

[0024] In the example shown there are four funnels, however other numbers of funnels can be used. The funnels 4 are connected via medical grade silicone tubing 5 via variable flow meters/valves 7 to bulkhead connectors 6 which are fixed in the top of the case 14. The test apparatus is connected through further tubing 9 to a manifold connected to the air supply passing through the endoscope irrigation channels in adrying cabinet during testing. The variable flow metres/valves 7 which can restrict airflow to between 0-1 Ol/min, and measure/restrict the flow of the air being tested through the funnels. These are controlled and set using knobs 8 situated on the outside of the test apparatus on the front of the case 11. A handle 2 is provided to enable the apparatus to be carried easily. The combination of the tubing 9 and the inverted funnel 4, when connected to a supply forms a path 17 for air to flow onto and over anything placed on the base 15.

[0025] Lugs 3 extend forward from the front of the case 1 and are received into the cassette 20 as described below with reference to figures 4 and 5.

[0026] The front 1 of the case has a transverse slot 16 immediately above the base 15, to enable a cassette tray to be inserted though the slot 16 and to rest on base 15 as described below.

[0027] The second part of the test apparatus comprises the cassette 20 shown in figures 4 and 5. The cassette is made of polymer, such as polypropylene, and stainless steel. It comprises a tray section 21 comprising a single piece of polymer mounted on either side on stainless steel sliders 22 each pass through a mounting block 23 which also act as a pair of hinge blocks for a stainless steel lid 24.

4

[0028] The cassette 20 has a stainless steel lid 24 having stainless steel lugs 25 with stainless steel pins 26 extending laterally into the hinge blocks 24. Blocks 24, lugs 25 and pins thus form a pair of hinges for the lid 24. Apertures 27 are provided to receive the lugs 3 (figurel).

[0029] Initially the sliders 22 are locked in place in the mounting blocks 23, with the lid 24 held closed by interaction between the edge of the lid 24 and the tray 21.

[0030] A locking pin in the mounting block (not shown) releases the stainless steel sliders when the lugs 3 are inserted into apertures 27, enabling tray 21 to slide forward into slot 16 in the case 1 (figure 1). Pushing the tray 21 fully into slot 16, the lid is freed to rotate up in front 11 of the case 1 covering the knobs 8 preventing their adjustment while the cassette is inserted into slot 16. When the tray 21 is push fully into the slot 16 it is below the four inverted funnels 4. Stops 28 prevent further forward movement of the tray beyond its working position when engaged into slot 16.

[0031] The tray itself has circular recesses 29 corresponding to the inverted funnels 4, and when the tray 21 is fully inserted into slot 16, the recesses lie directly below the inverted funnels 4. The recesses have a layer of silicon rubber 30 at their bottom and receive plates (not shown) containing a test medium. May suitable media are known to persons skilled in this field, but a Tryptone Soya Agar would be typical and is widely. The silicon rubber 30 enables the plates containing the medium to be held firmly against the lid 24 of the cassette when its lid 24 is closed. Once the tray 21 is fully inserted though the slot 16, the medium on the plates in the recesses 29 is exposed to air passing over the medium as the air is suck up through the inverted funnels 4.

[0032] The medium is thus exposed to the air flow for a set periods, after which the lid 24 is closed down and cassette pulled from the lugs 3 enabling the sliders and tray to slide back to their original positions under the lid, again with the silicon rubber 30 pushing the plates containing the test medium against the lid and sealing them. The cassettes are then taken to be tested

5

in a laboratory for the presence of bacteria which would have originated in the endoscopes.

[0033] In figure 4 the tray 21 is shown in its first closed position and in figure 5 in its second open position where it would normally have been inserted through slot 16 to rest on base 15, below the funnels 4.

6

Claims

1. A biological testing system to identify the possible existence of bacteria present on equipment characterised in that it includes an air distribution apparatus (10) providing at least one air path (17) to allow air which has been exposed to the equipment to uniformly pass over a culture medium (32).

2. A system according to claim 1 characterised in that it additionally comprises multiple air paths over multiple test medium cultures (32).

3. A system according to claim 1 or 2 characterised in that it additionally comprises has an air flow meter (7) in each air path (17) to measure the air supply to the culture medium (32).

4. A system according to claim 3 having characterised in that flow meter (7) also regulates the flow rate of air.

5. A system according to any preceding claim characterised in that it additionally comprises a cassette (20) which houses the culture medium (32).

6. A system according to claim 5 characterised in having a lid (24) on the cassette.

7. A system according to claim 5 or 6 characterised in that the cassette (20) has one or more recesses (29) to receive one or more plates (31) containing the culture medium (32).

8. A system according to claim 7 characterised in that each recess (29) in the cassette has a silicone rubber layer (30) pushing the said one or more plates into contact with the lid (24) when the lid (24) is closed.

9. A system according to any one of claims 5 to 8 characterised in that the cassette comprises a tray (21), said tray being mounted to slide to and fro between a first closed position and a second open position between a pair mounting blocks (23), the second open position is being a position in which the culture medium may be exposed to an air path (17), and a first closed position being a position in which the culture is not exposed to air.

10. A system according to claim 9 and in which the cassette has a hinged lid to protect the test media characterised in that the edge of said lid (24) interferes with the tray (21) to ensure that the lid is closed in said first position.

7

11. A system according to claim 10 characterised in that the air distribution apparatus (10) has engaging means (3) cooperating with a locking means associated with the cassette and in which the lid (24) remains closed and the tray in the said first closed position until the engaging means (3) is engaged with the cassette (20).

12. A system according to claim 11 characterised in that the engaging means comprises lugs (3) on the case (1), and locking means is in apertures (27) of the mounting blocks.

13. A system according to claim 12 characterised in that the lid (24) is mounted on lugs (25) having pins (26) pivotally mounted in the mounting blocks (23), the pins (26) pivoting in the mounting blocks (23) when the tray (21) moves from said fiist closed position to said second open position.

14. A system according to any preceding claim and including a cassette said cassette having a tray which may slide from a first closed position to second open position and back again characterised in that in the second open position the tray (29) is exposed to at least one air path (17).

15. A system according to any preceding claim characterised in that each air path includes an inverted funnel (4) mounted above the base, and in which culture medium (32) can be mounted below the said inverted funnels (4).

16. A system according to claim 15 including a cassette containing a culture medium characterised in that when the culture medium (32) is exposed to an air flow (17) adjustment of the air flow rate is prevented.

17. A system according to claim 16 and including a cassette, said cassette having a lid and a tray characterised in that when the tray is positioned in an air path (17) with the culture medium exposed to air flow in the air path, the lid of the cassette prevents access to the adjuster (8).

18. A system according to any preceding claim having a cassette containing a culture medium, a lid, and a tray characterised in that in moving from its first closed position to its second open the position the tray passes through a slot (16) in the case (1) of the air distribution apparatus (10) to rest in its second open position on the base (15) of the air distribution apparatus (10).

8

19. A system according to claim 18 characterised in that as the tray (21) of the cassette is withdrawn from the air distribution apparatus (10) the lid (24) of the cassette (20) closes on the tray sealing the culture media from air.

20. A system according to any preceding claim characterised in the equipment is endoscopes.

21. A system according to claim 20 characterised in that the endoscopes are contained in a storage cabinet and one or more of said air paths (17) are coupled to air passing through the cabinet by one or more ducts (9).

22. A system according to claim 21 characterised in that the storage cabinet is a drying cabinet.

23. A system according to any preceding claim characterised in that the air distribution apparatus is connected to air passing through endoscope irrigation channels.

24. A system according to any preceding claim characterised in that it is transportable by hand form one deployment site to another.

25. A biological testing system substantially as hereinbefore described with reference to the accompanying drawings.

9

•.'????.• INTELLECTUAL

*.*. .V PROPERTY OFFICE

10

Application No: GB 1202108.5 Examiner: Dr Jeremy Kaye

Claims searched: 1-25 Date of search: 6 June 2012

Patents Act 1977

Corrected Search Report under Section 17

Documents considered to be relevant: