WO2020044004A1

WO2020044004A1 - Apparatus for testing a liquid specimen

Info

Publication number: WO2020044004A1
Application number: PCT/GB2019/000117
Authority: WO
Inventors: Oliver Blackwell
Original assignee: Clinical Design And Technologies Limited
Priority date: 2018-08-28
Filing date: 2019-08-16
Publication date: 2020-03-05
Also published as: GB201813999D0

Abstract

Apparatus (2) for testing a liquid specimen, which apparatus (2) comprises: (i) a first container (4) for the liquid specimen; (ii) a response chart (14) which is operable in response to contact with the liquid specimen; and (iii) a viewing portion (32) for enabling the response chart (14) to be read, and the apparatus (2) is such that: (iv) the response chart (14) is spaced apart from the viewing portion (32) by a droplet-inhibiting distance (34) which inhibits the formation of droplets of the liquid specimen between the response chart (14) and the viewing portion (32), and thereby facilitates reading of the response chart (14) through the viewing portion (32).

Description

APPARATUS FOR TESTING A LIQUID SPECIMEN

This invention relates to apparatus for testing a liquid specimen.

Apparatus for testing liquid specimens is well known. If the liquid specimen is in the form of urine, then a dipstick is usually used to test the urine. The testing of urine with a dipstick is carried out many times a day in medical practices, clinics and hospitals around the world. The testing of the urine is essential in the diagnosis of urinary tract infections, for screening for protein and blood in the urine, and for the diagnosis of many other conditions.

The standard way in which the urine is tested with a dipstick involves a patient filling a container with urine, and then handing the container to an authorised person such for example as a nurse, a technician or a doctor. The authorised person is required to dip the dipstick into the urine in the container, wiping off excess urine on the rim of the container. The dipstick has response portions which are contacted by the liquid specimen, which become differently coloured to indicate different characteristics present in the urine The response portions are read against a result chart at predetermined time intervals. The entire procedure may take a number of minutes to perform effectively. The procedure is unhygienic and is prone to error if the response portions are read at incorrect time intervals.

WO 2011/157981 A1 and WO 2016/066983 A1 address the above problems. More specifically, WO 201 1/157981 A1 and WO 2016/066983 A1 disclose apparatus for testing a liquid specimen, with the apparatus comprising a first container for the liquid specimen, a response chart which is operable in response to contact with the liquid specimen, and a result chart for use with the response chart. The apparatus is such that the response chart is viewed via a viewing portion. With some liquid specimens, for example urine, the apparatus is inverted to cause the liquid specimen to contact the response chart. In this case, it may be that the liquid specimen, for example the urine, contacts the viewing portion. This contact with the viewing portion may be such that even after the apparatus is returned to its non-inverted position, the liquid specimen still obscures the view through the viewing portion. The result may be difficulty in reading the response chart through the viewing portion.

It is an aim of the present invention to reduce the above mentioned problem of the liquid specimen obscuring the view of the response chart.

Accordingly, in one non-limiting embodiment of the present invention, there is provided apparatus for testing a liquid specimen, which apparatus comprises:

(i) a first container for the liquid specimen;

(ii) a response chart which is operable in response to contact with the liquid specimen; and

(iii) a viewing portion for enabling the response chart to be read, and the apparatus is such that:

(iv) the response chart is spaced apart from the viewing portion by a droplet-inhibiting distance which inhibits the formation of droplets of the liquid specimen between the response chart and the viewing portion, and thereby facilitates reading of the response chart through the viewing portion.

The apparatus of the present invention is advantageous in that the spacing apart of the response chart from the viewing portion by the droplet- inhibiting distance inhibits the formation of droplets which could otherwise obscure the viewing of the response chart through the viewing portion, for example with liquid specimens of dark colours. The droplet-inhibiting distance may be such that it allows a liquid specimen to flow in and out of a gap between the viewing portion and the response portion. This ensures firstly that the response chart has absorbed sufficient of the liquid specimen when the first container is inverted, and secondly that excess of the liquid specimen is able to drain away from the response chart when the first container is re-inverted.

The apparatus of the present invention is preferably one in which the droplet-inhibiting distance is 4 - 7mm. Preferably the droplet-inhibiting_; distance is 5.5mm. Other droplet-inhibiting distances may be employed so that, for example, the droplet-inhibiting distance may be in a range of less than 3mm to substantially longer than 7mm.

The apparatus may be one in which the response chart is inside a second container and is contacted by the liquid specimen when the liquid specimen enters the second container.

The apparatus may be one in which the apparatus includes: (i) a lid for closing the first container after the liquid specimen has been provided in the first container;

(ii) first securing means by which the lid is secured to the first container; and

(iii) second securing means by which the second container is secured to the lid, and the apparatus is such that:

(iv) the second container secures to the lid when the lid is on the first container;

The apparatus may be one in which:

(i) the lid has an openable portion which when opened permits the liquid specimen in the first container to enter the second container; and

(ii) the second container has opener means for opening the openable portion on the lid.

The apparatus may be one in which the viewing portion is a transparent portion for us in permitting optical reading of the response chart through the viewing portion of the second container. If desired, the response chart may be read other than by optical reading in the optical visible frequency spectrum. For example, the reading through the viewing portion may be effected using infra- red frequencies or ultraviolet frequencies.

The first securing means may be a screw-operated first securing means. Other types of first securing means may be employed so that, for example, the first securing means may be a push fit first securing means.

The second securing means may be a push fit securing means. Other second securing means may be employed so that, for example, the second securing means may be a screw fit second securing means.

The second securing means may comprise an outwardly extending formation on the first container, and an inwardly extending formation on the second container. The outwardly extending formation on the first container may be a lip which is angled outwardly away from a top of the first container. Other types of outwardly extending formation may be employed.

The inwardly extending formation on the second container may be an inclined bead formation. Other types of inwardly extending formation may be employed.

The apparatus may include a bung for causing the opened openable portion to be closed in order to prevent the liquid specimen returning to the first container.

The apparatus may include third securing means by which the bung is maintained in its closing position.

The third securing means may be an inwardly extending lip. Other types of third securing means may be employed.

The apparatus may include a failsafe means for preventing the accidental locking of the bung causing the opened openable portion to be closed. The failsafe means may be a rotate and push failsafe means. Other types of failsafe means may be employed.

The openable portion of the lid may be a foil or a membrane. Other types of openable portion may be employed.

The opener means of the second container may be a puncturing formation for puncturing the openable portion of the lid. The puncturing formation may be a cylindrical formation having a free end which extends at an angle to the openable portion of the lid. Other puncturing formations may be employed so that, for example, the puncturing formation may be one or more pins. The cylindrical formation with the free end which extends at an angle to the openable portion of the lid is preferred because the free end forms a point for opening purposes. Preferably, the part opposite the free end has a flat section which prevents the formation of a complete cut circle. This flat section causes a hinge to be created in the punctured openable portion, whereby a cut part of the openable portion does not fall into the liquid specimen. This flat section also passes through the openable portion and holds open the punctured portion of the openable portion parallel to the longitudinal axis of the second container, thereby ensuring that the openable portion does not interrupt the flow of the liquid specimen. The apparatus may be one in which the first container is a tube of a diameter for fitting into laboratory test equipment. In this case, the tube may be a test tube or a primary tube. A primary tube is a test tube but with a screw thread for receiving a lid.

The apparatus may be one in which the response chart comprises response portions which are contacted by the liquid specimen, and which become differently coloured to indicate different characteristics present in the liquid specimen. The response portions may be read at predetermined time intervals. The response portions may be arranged in a circle, The response portions may be arranged other than in a circle if desired.

The apparatus may be one in which the response portions are positioned on plinths. The plinths will typically be such that there is one plinth for each one of the response portions. The plinths may advantageously aid drainage of the liquid specimen from the response chart. The plinths may also help to prevent colours from the response portions running and mixing with colours of other response portions.

The apparatus may be one which includes gradients which extend away from the response chart and which encourage drainage of the liquid specimen away from the response chart.

The apparatus of the present invention may include an electronic reader for reading the response chart. The electronic reader may be a digital reader. Other types of electronic reader may be employed.

The apparatus of the present invention may alternatively be one in which the reading of the response chart is effected manually. In this case, the apparatus may include a manual reader for reading the response chart.

The apparatus of the present invention may be used for testing a wide variety of liquid specimens. Usually the liquid specimens will be body fluid liquid specimens but other liquid specimens may be tested. Where the liquid specimens are body fluid liquid specimens, then the liquid specimens may be urine, blood or spinal fluid.

Embodiments of the invention will now be described solely by way of example and with reference to the accompanying drawings in which:

Figure 1 is a longitudinal section through apparatus of the present invention and in a partially exploded form;

Figure 2 is a longitudinal sectional view like Figure 1 but shows the component parts of the apparatus together and in a first position;

Figure 3 is a view like Figure 2 but shows the component parts of the apparatus in a second position;

Figure 4 illustrates a first step in an operating sequence of the apparatus;

Figure 5 illustrates a second step in the operating sequence of the apparatus;

Figure 6 illustrates a third step in the operating sequence of the apparatus;

Figures 7 - 11 illustrate an entire sequence of operations of the apparatus from the aspect of a person effecting testing of a liquid specimen;! Figure 12 shows the apparatus of the present invention being provided with result-obtaining means in the form of a result chart;

Figure 13 shows the apparatus of the present invention being provided with result-obtaining means in the form of a camera and an electronic reader; and

Figure 14 shows part of alternative apparatus of the present invention.

Referring to Figures 1 - 1 1 , there is shown apparatus 2 for testing a liquid specimen. The apparatus 2 comprises a first container 4 for the liquid specimen. The apparatus 2 also comprises a lid 6 for closing the first container 4 after the liquid specimen has been provided in the first container 4. First securing means 8 enables the lid 6 to be secured to the first container 4.

The apparatus 2 further comprises a second container 10 for securing to the lid 6 when the lid 6 is on the first container 4. Second securing means 12 enables the second container 10 to be secured to the lid 6

The apparatus 2 further comprises a response chart 14 which is operable in response to contact with the liquid specimen. The response chart 14 is in the second Container 10.

The apparatus 2 is such that the lid 6 has an openable portion 18 which when Opened permits the liquid specimen in the first container 4 to enter the second container 10. The second container 10 is inverted briefly to allow this to happen, see Figure 9. The second container 10 has opener means 20 for opening the openable portion 18 on the lid 6 when the second container 10 is secured to the lid 6. The response chart 14 inside the second container 10 is contacted by the liquid specimen when the iquid specimen enters the second container 10.

The apparatus 2 includes closure means 22 which acts to close the openable portion 18 after the openable ponion 18 has been opened and the liquid specimen in the first container 4 has Contacted the response chart 14 in the second container 10. More specifically, the closure means 22 comprises a housing 24 which fits over the second securing means 12. The housing 24 contains a bung 26 which depends from a too part 28 of the housing 24. When the housing 24 is moved from the position shown in Figure 2 to the position shown in Figure 3, then the bung 26 is located in a central aperture 30 in the opener means 20. When the opener means 20 has opened the openable portion 18, then the opener means 20 is located in the created opening in the openable portion 18. Thus the bung 26 is in the central aperture 30 in the opener means 20, and the opener means 20 is in the opened openable portion 18. Thus the bung 26 is effective to retain the liquid specimen in the first container 4.

The top part 28 of the housing 24 has a viewing portion 32 for enabling the response chart 14 to be read. The housing 24 is made of a transparent plastics material of a quality which enables the viewing portion 32 easily to be seen through in order view the response chart 14.

The response chart 14 is spaced apart from the viewing portion 32 by a droplet-inhibiting distance 34 which inhibits the formation of droplets of the liquid specimen between the response chart 14 and the viewing portion 32. This thereby facilitates reading of the response chart 14 through the viewing portion 32. More specifically, the formation of droplets is able to be minimised or reduced* and thereby prevents these droplets from obscuring the view of the response chart 14 through the viewing portion 32 which could occur with some liquid specimens, and especially dark coloured liquid specimens. The droplet- inhibiting distance 34 is sufficiently large to space the response chart 14 from the underside of the viewing portion 32 so that a droplet of typical size cannot get trapped in the gap between the underside of the viewing portion 32 and the response chart 14. When the droplet-inhibiting distance 34 is equal to or less than a typical droplet size, the droplet may become trapped between the underside of the viewing portion 32 and the response chart 14. When the droplet-inhibiting distance 34 is greater thanthe typical droplet size, gravity may pull the liquid specimen downwards and therefore away from the underside of the viewing portion 32. In addition, a distance which is greater than a typical droplet size may allow the liquid specimen easily to flow in and out of the second container 10.

The first securing means 8 is a screw-operated first securing means 8 and, as shown, comprises internal threads 36 on the lid 6 and external threads 38 on the first container 4. Thus the lid 6 screws to a top part 40 of the first container 4. The second securing means 12 is a push fit securing means 12. Thus the second securing means 12 is a push fit over the lid 6 as shown in Figures 1 , 2 and 3. The second securing means 12 has an internal bead 42 which locates under a rim 44 of the lid 6.

The openable portion 18 of the lid 6 is a foil. The openable portion 18 may alternatively be a membrane or other member.

The opener means 20 of the second container 10 has a puncturing formation 46 for puncturing the openable portion 18 of the lid 6. The puncturing formation 46 is a cylindrical formation 46 having a free end 48 which extends at an angle to the openable portion 18 of the lid 6 as shown. The free end 48 provides a focussing opening force at a point to puncture the openable portion 18 of the lid 6. A part of the opener means 20 opposite the free end 48 has a flat section 50 which prevents the formation of a complete cut circle. This flat section 50 causes a hinge to be created in the punctured openable portion 18. Thus the cut part of the openable portion 18 of the lid 6 does not fall into the liquid specimen in the first container 4. This flat section 50 also passes through the openable portion 18 and holds open the punctured portion of the openable portion 18 parallel to the longitudinal axis of the second container 10, thereby ensuring that the openable portion 18 does not interrupt the urine flow.

The container 4 may be a test tube or what is known as a primary tube in the field of medical diagnostics.

The response chart 14 comprises response portions 52 which are contacted by the liquid specimen, which become differently coloured to indicate different characteristics present in the liquid specimen, and which are read at predetermined time intervals. The response chart 14 is inside the second container 10 such that the response chart 14 is in a test chamber. The response portions 52 are arranged in a circle but they may be disposed in other configurations. The response portions 52 a;e shown as pads but they may be of other constructions.

Figures 1 and 2 illustrate the use of the apparatus when cutting of the openable portion 18 occurs. Figures 4, 5 and 6 illustrate how the apparatus 2 is operated to cause the closure means 22 to go from the position shown in Figure 2 to the position shown in Figure 3. (n going from the position shown in Figure 2 to the position shown in Figure 3, rotation and a push are required.

Figure 4 shows how the second container 10 has a pin 54 which operates in an L-shaped slot 56. The pin 54 and the slot 56 form a locking mechanism. As shown in Figure 4, there is one of the pins 54 and one of the slots 56 on opposite sides of the lid 6. During use of the apparatus 2, the housing 24 is rotated from the position shown in Figure 4 to the position shown in Figure 5. In the position shown in Figure 5, the pin 54 is positioned in a vertical part 58 of the slot 56. The housing 24 can then be pushed down to then occupy the position shown in Figure 6. In Figure 6, the pin 58 is in its final resting position in the slot 56. In this position, the housing 24 has been fully depressed and the bung 26 is in its container-closing position in the central aperture 30.

The apparatus 2 comprises third securing means 57. The third securing means 57 comprises an inwardly projecting bead 59 which moves from its locating position shown in Figures 1 and 2 to the position shown in Figure 3. In the position showing in Figure 3, the bead 59 prevents the closure means 22 from being pulled upwardly and back to the position shown in Figure 2. Thus the third securing means 57 prevents the bung 26 from being moved back to a non-closing position and so the bung 26 is maintained in its container-closing position.

Figures 7 - 11 illustrate the use steps of the apparatus 2 of the present invention. More specifically, Figure 7 illustrates the second container 10 being placed on the lid 6, with the lid 6 being on the top part 40 of the first container 4. Figure 8 shows the second container 10 in position on the first container 4. In Figure 8 the opener means 20 will have cut through the openable portion 18. The first container 4 is then inverted as shown in Figure 9 to enable the liquid specimen in the container 4 to contact the response chart 14. Figure 10 shows how the apparatus 2 is then re-inverted back o its normal position as shown in Figure 8. The response chart 14 is then read. Figure 1 1 shows how the second container 10 is then operated to lower the housing 24 to cause the bung 26 to locate in the aperture 30 and thereby seal the second container 10 from the first container 4. In Figures 7 - 1 1 , the liquid specimen has been shown as a liquid specimen in the form of urine 60. Other types of liquid specimen may however be employed. The response chart 14 used may be varied in dependence upon the particular type of liquid specimen being tested.

Figure 12 shows how the response chart 14 is able to be read by result- obtaining means in the form of a result chart 62. The result chart 62 has a central aperture 64 which enables the result chart 62 to fit over the housing 24. The result chart 62 comprises result sectors which are complementary to the responsive portions 52, for example pads, forming the response chart 14. The result chart 62 is read by a qualified person who is shown schematically by an eye 66. The person is able to match colours on the response portions 52 of the response chart 14 with similar colours on coloured sectors On the result chart 62, in order to obtain the best result for the liquid specimen 60.

Figure 13 shows how the apparatus 2 may alternatively be read using an electronic reader 68. The electronic reader 68 comprises a housing 70 which houses a camera/reader means 72. The camera/reader means 72 comprises a camera 74 which is located at one end of a viewing cone 76. The viewing cone 76 has stepped portions 78 for reducing reflection inside the viewing cone 76 to the camera 74. The viewing cone 76 fits over the top end of the apparatus 2 as shown. The droplet-inhibiting distance 34 is shown. The camera 74 is operated digitally and its results are read by a reader forming part of the camera/reader means 72. The results are then analysed digitally by appropriate electronic software and hardware forming part of result-obtaining means in the form of an analyser which analyses the response of the response portions 52 Of the response chart 14, and gives an appropriate result of the liquid specimen under test, for example the liquid specimen in the form of the urine 60.

Referring now to Figure 14, there is shown part of alternative apparatus 80 of the present invention. Similar parts as in previous Figures have been given the same reference numerals for ease of comparison and understanding. In the apparatus 80, the response portions 52 are separated by gradients 82. The gradients 82 slope radially inwardly and thus they extend away from the response chart. This encourages drainage of the liquid specimen away from the response chart, that is away from the response portions 52 and back into the first container 4 through the aperture 30.

It is to be appreciated that the embodiments of the invention described above with reference to the accompanying drawings have been given by way of example only and that modifications may be effected. Thus, for example, the apparatus 2 may be constructed such that the second container 10 is not required, and in this case, the viewing portion 16 may be positioned on another part of the apparatus. The first container 4 may be Shorter and of a larger diameter than the first container 4 shown. Other types of response chart 14 may be employed. The second container 10 may be positioned inside the first container 4. Individual components shown in the drawings are not limited to use in their drawings and they may be used in other drawings and in all aspects of the invention. The invention also extends to the individual components mentioned and/or shown above, taken singly or in any combination.

Claims

1. Apparatus for testing a liquid specimen, which apparatus comprises:

(i) a first container for the liquid specimen;

2. Apparatus according to claim 1 in which the droplet-inhibiting distance is 4 - 7mm.

3. Apparatus according to claim 2 in which the droplet-inhibiting distance is 5.5mm.

4. Apparatus according to any one of claims 1 - 3 in which the response chart is inside a second container and is contacted by the liquid specimen when the liquid specimen enters the second container.

5. Apparatus according to claim 4 in which the apparatus includes:

(i) a lid for closing the first Container after the liquid specimen has been provided in the first container;

(iv) the second container secures to the lid when the lid is on the first container.

6. Apparatus according to claim 5 in which:

7. Apparatus according to any one of claims 4 - 6 in which the viewing section is a transparent portion for use in permitting optical reading of the response chart through the viewing portion of the second container.

8. Apparatus according any one of claims 5 - 7 in which the first securing means is a screw operated first securing means.

9. Apparatus according to any one of claims 5 - 8 in which the second securing means is a push fit securing means.

10. Apparatus according to any One of claims 5 - 9 in which the second securing means comprises an outwardly extending formation on the first container, and an inwardly extending formation on the second container.

1 1. Apparatus according to claim 10 in which the outwardly extending formation on the first container is a lip which is angled outwardly away from a top of the first container.

12. Apparatus according to claim 10 or claim 1 1 in which the inwardly extending formation on the second container is an inclined bead formation.

13. Apparatus according to claim 6 or any claim dependent on claim 6, and including a bung for causing the opened openable portion to be closed in order to prevent the liquid specimen returning to the first container.

14. Apparatus according to claim 13 and including third securing means by which bung is maintained in its closing position.

15. Apparatus according to claim 13 in which the third Securing means is an inwardly extending lip.

16. Apparatus according to any one of the preceding claims and including a failsafe means for preventing the accidental locking of the bung causing the opened openable portion to be closed.

17. apparatus according to claim 16 in which the failsafe means is a rotate and push failsafe means.

18. Apparatus according to claim 6 or any claim dependent on claim 6 in which the openable portion of the lid is a foil or a membrane.

19. Apparatus according to claim 6 or any claim dependent on claim 6 in which the opener means is a puncturing formation for puncturing the openable portion of the lid.

20. Apparatus according to claim 19 in which the puncturing formation is a cylindrical formation having a free-end which extends at an angle to the openable portion of the lid.

21. Apparatus according to any one of the preceding claims in which the container is at tube of a diameter for fitting into laboratory test equipment.

22. Apparatus according to claim 21 in which the tube is a test tube or a primary tube.

23. Apparatus according to any one of the preceding claims in which the response chart comprises response portions which are contacted by the liquid specimen, and which become differently coloured to indicate different characteristics present in the liquid specimen.

24. Apparatus according to claim 23 in which the response portions are arranged in a circle.

25. Apparatus according to claim 23 or claim 24 in which the response portions are positioned on plinths.

26. Apparatus according to any one of the preceding claims and including gradients which extend away from the response chart and which encourage drainage of the liquid specimen away from the response chart.

27. Apparatus according to any one of the preceding claims and including an electronic reader for reading the response chart.

28. Apparatus according to claim 27 in which the electronic reader is the digital reader.

29. Apparatus according to any one of claims 1 - 25 and which is such that reading of the response chart is effected manually.