WO2022103371A2

WO2022103371A2 - A urine test strip cassette

Info

Publication number: WO2022103371A2
Application number: PCT/TR2021/051182
Authority: WO
Inventors: Utku Uluşahi̇n; Ahmet ULUDAĞ; Ali Oğulcan DÜLGER
Original assignee: Oruba Medi̇kal Teknoloji̇ Arge İç Ve Diş Ti̇c.Ltd.Şti̇.
Priority date: 2020-11-10
Filing date: 2021-11-10
Publication date: 2022-05-19
Also published as: WO2022103371A3

Abstract

The present invention relates to a test strip cassette for use in devices for testing urine samples using test strips. The present invention aims at developing a cassette that facilitates test strip loading into devices that analyze urine content using test strips. The invention also ensures that the test strips in the said cassette cannot be used once again by moving them in one direction. The important features of the cassette are that water, soap or abrasives used for cleaning the urine that accumulates on the test strips and splashes into the cassette do not come into contact with the unused test strips and that the urine or cleaning liquids in the cassette can be easily emptied.

Description

A URINE TEST STRIP CASSETTE

Technical Field

The present invention relates to a test strip cassette for use in devices for testing urine samples using test strips.

Background of the Invention

It is possible to diagnose many diseases or the current state of health by analyzing the content of the urine samples. Absorbent surfaces impregnated with reactive chemicals are used for chemical content determination. These absorbent surfaces undergo a color change by reacting with the chemicals in their contents. The amount of relevant parameters in the urine content can be determined by examining this color change by means of a scale consisting of predetermined colors.

Biomarkers in urine that can be quantified using a test strip, can detect protein, glucose, ketone, hemoglobin, bilirubin, urobilinogen, pH, specific gravity, nitrite and leukocyte. These biomarkers provide data to physicians to diagnose many diseases. Therefore, tests and content analysis related to urine samples are very often performed by using strips in healthcare organizations.

Today, there are patent applications to carry out automatic urine tests with strips placed in toilets. One of these is described in US10605717 United States patent application. In the said patent application, it is described that many strips placed under a toilet bowl are wetted with the urine of the users and urine analysis is performed.

Summary

The present invention aims at developing a cassette that facilitates test strip loading into devices that analyze urine content using test strips. The invention also ensures that the test strips in the said cassette cannot be used once again by moving them in one direction. The important features of the cassette are that water, soap or abrasives used for cleaning the urine that accumulates on the test strips and splashes into the cassette do not come into contact with the unused test strips and that the urine or cleaning liquids in the cassette can be easily emptied.

Detailed Description The urine strip cassette realized to achieve the objectives of the invention is shown in the attached figures, in which;

Figure 1 - is the perspective view of the said urine strip cassette.

Figure 2 - is the top view of the said urine strip cassette.

Figure 3 - is the front view of the said urine strip cassette.

Figure 4 - is the bottom view of the said urine strip cassette.

Figure 5 - is the exploded perspective view of the said urine strip cassette.

Figure 6 - is the front view of said urine strip cassette including a blocker, a stopper and a rectifier.

Figure 7 - is the detailed front view of the blocker and stopper parts of said urine strip cassette.

Figure 8 - is the front view of the housing of said urine strip cassette including stopper and rectifier.

Figure 9 - is the detailed view of the rectifier part in the urine strip cassette.

The parts in the figures are numbered and the corresponding numbers are given below.

1. Cassette

2. Strip

3. Housing

4. Lid

5. Empty roller

6. Full roller

7. Slot

8. Opening

9. Safety 10. Chamber

11. Pin

12. Dry Chamber

13. Wet Chamber

14. Separation wall

15. Blocker

16. Stopper

17. Rectifier

18. Flake

Said cassette (1) ensures that the urine sample reaches the urine test strips (2) while the urine test strips (2) pass from the full roller (6) to the empty roller (5). The full roller (6) and the empty roller (5) are fit in the pin (11) and the slot (7) on the housing (3) of the cassette (1), respectively. While the full roller (6) can rotate freely around the pin (11), the empty roller (5) can rotate inside its slot (7) with the motor drive taken from outside.

With the rotation of the empty roller (5) in the wet chamber (13), the test strips (2), which are positioned as wound on the full roller (6), are drawn and the test strip (2) moves linearly along the gap between the housing (3) and the lid (4) of the cassette (1). During this linear movement of the test strip (2), it is possible to drip, spray and pour urine onto the urine analysis pads. In case of excessive flow during wetting of the pads with urine, it is necessary that this flow should not come to the unused test strips (2) on the full roller (6) and liquid contact to the dry chamber (12) should not be ensured.

The inner volume formed between the housing (3) and the lid (4), which is one of the elements of the cassette (1), is divided into two as the dry chamber (12) and the wet chamber (13) by the separation wall (14). Through this separation wall (14), liquid flow between the dry chamber (12) and the wet chamber (13) is prevented. The full roller (6) is located in the dry chamber (12). In this way, the test strips (2), which are wound on the full roller (6) located in dry chamber (12) which is not contacted with liquid, are prevented from contacting the test strips (2) with urine and the liquids transferred on the cassette (1) during the cleaning stages. The empty roller (5) is located in the wet chamber (13). A safety (9) is integrated with the separation wall (14) on the upper part of the separation wall (14) where the test strips (2) coming out of the full roller (6) exit from the dry chamber (12) in order to protect it from excess urine during wetting of the test strips (2) with urine. The safety (9) ensures that both the test strip (2) remains strained and the drops of urine accumulates and are directed to the wet chamber (13) inside the cassette (1). In this state, the safety (9) and the separation wall (14) divide the volume between the housing (3) and the lid (4) into two different volumes as the wet chamber (13) and the dry chamber (12). While unused test strips (2), which are likely to be affected by the humidity of the environment, are wrapped in a full roller (6) and stored in the dry chamber (12) dehumidifiers in the chamber (10) close to the bottom of the dry chamber (12) will be usable in order to create a moisture-free environment in the dry chamber (12).

While the test strips (2) come into contact with urine, urine drops overflowing and splashing into the environment may cause odor and bacterial growth. To prevent this, it is possible to spray water and/or cleaning chemicals inside after each test operation. This spraying will be done towards the empty roller (5) side, thus towards the wet chamber (13), similar to urine spraying. In order to prevent both urine and cleaning chemicals from accumulating in the cassette (1), there is an opening (8) that allows the wet chamber (13) to be emptied thanks to the housing (3) on the lower face of the cassette (1).

The opening (8) ensures that all the liquids accumulating on the wet chamber (13) side are discharged. A drainage system that falls under the opening (8) can collect and discharge the liquids flowing down the opening (8). In addition to this, it can be provided that a vacuum is made through this opening (8) and the extracted air can be passed through the filters and returned to the environment in order to remove the odors inside along with the liquid.

The cassette (1) is suitable for the operator to read the test strips (2) that have been in contact with urine, either visually or with a camera of an automatic system. The biomarkers on the test strips (2) change color with the effect of urine spilled on impregnated felts. By considering the similarity of the changing color on the color scale, the values of protein, glucose, ketone, hemoglobin, bilirubin, urobilinogen, pH, specific weight, nitrite, hemoglobin, leukocytes and similar parameters in the urine can be determined. The cassette (1) may have a color scale placed on the upper face of the cassette (1) parallel to the test strip (2) so that the said color change can be easily evaluated. This color scale will be placed next to the test strip (2) so that changing colors can be compared. The lighting in the environment where the cassette (1) is located will enable a more accurate comparison by illuminating both the strips (2) and this color scale at the same time. However, the color of the test strips (2) can be black, white or any other special color to facilitate reading.

The test strips (2) in the cassette (1) may include 10, 20, 50, 75, 100 or more test strips (2) depending on the dimensions of the full roller (6) and the housing (3). If all of the test strips (2) are used and wound on the empty roller (5), the usable test strips (2) in the cassette (1) will be finished. When the finished cassette (1) is changed, new test strips (2) can run in different color scales due to both manufacturing differences and being affected by the environment in the stocking area. In order to eliminate such differences, a color scale printed, pasted and added on each cassette (1) will be used instead of using the predefined color scale loaded into the software.

Each cassette (1) shall have a unique serial number, barcode, QR code, NFC tag. The production date, the number of test strips (2) in the cassette (1) and even the owner of the cassette (1) can be determined by means of this number or barcode or QR code or NFC tag. Owner information of the cassette (1) will be tracked by registration in the system, when this cassette (1) is sold. How many cassettes (1) inventory each user and their device has, how many test strips they use and the remaining amount can be tracked. If the users utilize more cassette (1) than they have, feedback will be given on misuse or mis-improvement, and the device will be prevented from working in case the possibility of using the same cassette (1) again.

In the above-described embodiment of the invention, an opening (8) is described for evacuating the urine that is incorrectly filled into the cassette (1), the urine that is discharged during the cleaning of the pipeline carrying the urine, and/or the water and cleaning chemicals that are filled during the cleaning of the urinary line. In cases where the bottom of the cassette (1) is closed instead of this opening (8), it is also possible to draw liquid from the cassette (1) via a suction line. The connection of the suction line to the suction motor will be provided by placing the cassette (1) in its slot. Suction line will ensure that the liquids that can accumulate in the cassette (1) are removed without any accumulation or after they have accumulated to a certain level for washing by suctioning continuously or at certain intervals during operation.

It is possible to take the accumulated liquids from a one-way valve or hole located near the bottom of the cassette (1) in order for the liquid to be drawn from the cassette (1). In this state, while both vacuuming the liquids from the cassette (1) and sending them to the drain by gravity are directly possible in the use of holes, it is possible to open the cover that will form an opening (8) while the cassette (1) is seated in order to open the valve during the use of a one-way valve. With the increase in the amount of test strips (2) wrapped on the empty roller (5) in said cassette (1), it is possible that the dirty test strips (2) that have come into contact with the urine will move the empty roller (5) in the opposite direction of the winding. In this case, it is not possible for the test strips (2) exposed at the top of the cassette (1) to remain tight as desired for observation. Accurate observation may not be possible if the linearly moving test strips (2) are not remain curved planarily or tight. In order for the test strips (2) in the cassette (1) to remain tight in the plane where the linear movements are carried out, the circular movement of the empty roller (5) must be prevented against the winding direction. In this context, it is possible to design the outer wall of the empty roller (5) as a blocker (15) in the form of a saw blade consisting of zigzags. The blocker (15) in the form of saw blade inside the housing (3) will be used together with a stopper

(16) which will stop the movement against the winding direction by passing into the teeth of the blocker (15). The tooth structure of the blocker (15) and the position of the stopper (16) shall be designed to stop movement in the opposite winding direction while allowing movement in the winding direction. In this way, if the empty roller (5), which is rotated around the slot by motor drive, moves to the winding direction in the wet chamber (13), the teeth of the blocker (15) will be able to move by sliding over the stopper (16). In case of movement against the winding direction, it will be ensured that the teeth of the blocker (15) will be stopped by engaging to the stopper (16) and thus the tension of the test strips (2) on the upper part of the cassette (1) will be maintained.

The test strips (2) which are housed in the cassette (1) and move from the full roller (6) to the empty roller (5), move linearly for displaying after contact with urine. The test strips (2) are expected to be tight during this linear motion. The test strips (2) are pulled by the empty roller (5), which is rotated by the motor drive while providing this tightness. However, on the side of the full roller (6), a variable friction force also should be provided according to the conjugate and the fullness of the rollers. Accordingly, a rectifier (17) will be used in the dry chamber (12) before the part in which the test strips (2) are directed from the full roller (6) to the safety (9). The rectifier

(17) will basically provide the necessary friction force by transferring the power to be transferred from the lid (4) to the side surfaces of the test strips (2) with the help of the spring on it as well as aligning the test strips (2) passing through. The variable friction force required for the tight positioning of the test strips (2), which will be located on the upper side of the cassette (1) will be provided by the rectifier (17), which transfers the required power to the test strips (2) with the help of the spring. The rectifier (17) is designed as a free element with a slot for the spring to pass on. Beside of the slot, includes a housing with a groove in the body that enables the test strip (2) to be guided, and a cavity between which the test strip (2) can pass away and a protrusion that will increase friction by pressing on the side surface of the test strip (2).

Flakes (18) are able to be used in order for the test strips (2) to move away from the lid (4) at all turning points where change of the angular directions of the test strips (2) in the cassette (1) to ensure test strips (2) orientation. These flakes (18) will basically be such that the turning points are positioned between the cassette (1) and the lid (4) and such that the test strips (2) do not move towards the cover by comprising a circular area of a greater diameter than the circular area of the turning points. Flakes (18) are expected to contain a gap directly proportional to the diameters of the turning points at the points where they are attached to the turning points and to have a larger diameter than the diameters of the turning points at the points which are close to lid (4).

Claims

CLAIMS A cassette (1) for devices that allow urine samples to be tested using test strips, which; allows the urine sample to reach onto the strips (2) during the urine test strips (2) passing from the full roller (6) to the empty roller (5); a safety (9) to prevent urine from reaching the unused test strips (2) while dripping or spraying or pouring urine on the test strip (2). A cassette (1) according to Claim 1 characterized in that an opening (8) is used to prevent excess urine or water and/or chemicals from accumulating on the test strips (2). A cassette (1) according to Claims 1-2 characterized in that the color scale is placed on the upper face of the cassette (1) parallel to the test strip (2) to detect the color change of the test strip (2). A cassette (1) according to Claim 1 characterized in that the suction line is used to suck up excess urine or water and/or chemicals on the test strips (2). A cassette (1) according to Claims 1-2 characterized in that the separation wall (14) is positioned to prevent liquid passage between the dry chamber (12) and the wet chamber (13) during the processes of dripping, spraying and pouring urine onto the urine analysis pads on the test strips (2). A cassette (1) according to Claims 1-2 characterized in that it contains a blocker (15) in the saw blade structure consisting of zigzags on the outer wall of the empty roller (5) and a stopper (16) that stops the movement in the opposite direction of winding by passing into the teeth of the blocker (15) in order to prevent the dirty test strips (2) that have come into contact with the urine from moving the empty roller (5) in the opposite direction of the winding with the increase in the amount of the test strips (2) wound on the empty roller (5) and to maintain the linear position of the test strips (2). For providing the frictional force necessary to keep the test strips (2) taut during linear motion In order to observe the test strips (2) in the cassette (1) moving from the full roller (6) to the empty roller (5), a cassette (1) according to Claims 1-2 characterized in that comprising a rectifier (17) which; presses the side surface of the test strips (2) to align the test strips (2) and; transfers the opposing force obtained from the lid (4) to the side surface of the test strips (2) with the help of the spring inserted into it. A cassette (1) according to Claims 1-2 characterized in that comprising a flake (18) at which turning points are placed between cassette (1) and lid (4) and points close to the

8 lid (4) have greater diameter than diameter of turning points in order for providing the test strips (2) to move away from the lid (4) at all turning points where the angular directions of the test strips (2) that will move in the cassette (1) change, and thus ensuring their orientation.

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