Integrated blood testing device

Abstract

A blood testing device including: a housing including spaced apart walls, the housing including a sampling zone and one or more testing zones; the sampling zone including: a membrane piercing element disposed at least partially in the housing, the membrane piercing element being a lancet for piercing a membrane of a patient to release an amount of blood from the patient; the or each testing zone including: one or more buffer stations, the or each buffer station including: a buffer dock for docking a buffer reservoir, the buffer dock disposed at least partially in the housing and including a fluid outlet; a buffer reservoir disposed in the buffer dock; a buffer reservoir cutter for cutting the buffer reservoir; one or more mixing stations, the or each mixing station including: a mixing chamber in an interior of the housing including a mixing chamber inlet; a blood collection station including an aperture disposed in a top wall for receiving the blood from the patient therethrough from outside the top wall to the mixing chamber; a buffer transfer gallery disposed between the or each buffer station fluid outlet and one or more of the mixing station inlets; and one or more test beds extending from the one or more mixing chambers, wherein a test strip is disposed on the test bed and at least partially in the mixing chamber for receiving the mixed blood and buffer, and displaying a test result on a result portion.

Description

Integrated blood testing deviceTechnical Field

[0001] The present technology relates generally to blood testing devices.Background Art

[0002] When testing blood and other body fluids for various markers, various kits can be used. One of the problems is that there are many parts that need to be unwrapped, set up and held in various orientations while the testing is being conducted. All the parts mean more landfill, and confusion for users during the test.

[0003] There are known testing devices which provide more integrated parts. That is, some include lancets, buffer reservoirs and testing strips in a single body.

[0004] However, these known devices are inefficient and complex in that they include a range of moving parts and wasted space.

[0005] Ergonomically, the known devices are clunky and difficult to use, since, among other reasons, they require button pressing, while positioning of hands and fingers in overlapping ways.

[0006] The known devices, in addition, are bulky, heavy and still involve much disposable waste.

[0007] The present invention seeks to ameliorate one or more of the abovementioned disadvantages or at least provide a new alternative to known devices.Summary of Invention

[0008] In accordance with one aspect of the present invention there is provided a blood testing device including: a housing including spaced apart top, bottom, end and side walls, the housing including a sampling zone and one or more testing zones; the sampling zone including: a membrane piercing element disposed at least partially in the housing, the membrane piercing element being a lancet for piercing a membrane of a patient to release an amount of blood from the patient; the or each testing zone including: one or more buffer stations, the or each buffer station including: a buffer dock for docking a buffer reservoir, the buffer dock disposed at least partially in the housing and including a fluid outlet; a buffer reservoir disposed in the buffer dock; a buffer reservoir cutter for cutting the buffer reservoir; one or more mixing stations, the or each mixing station including: a mixing chamber in an interior of the housing including a mixing chamber inlet; a blood collection station including an aperture disposed in a top wall for receiving the blood from the patient therethrough from outside the top wall to the mixing chamber; a buffer transfer gallery disposed between the or each buffer station fluid outlet and one or more of the mixing station inlets; and one or more test beds extending from the one or more mixing chambers, wherein a test strip is disposed on the test bed and at least partially in the mixing chamber for receiving the mixed blood and buffer, and displaying a test result on a result portion.

[0009] The housing could be any particular format that facilitates ready presentation of the structural elements defined above. It could be linear, round, cylindrical, or other suitable shape.

[0010] In one embodiment the housing includes a cassette-style device which is essentially a flat rectangle.

[0011] In one embodiment the housing includes a notch or cutout or bevel or a chamfer for presenting the lancet to a user.

[0012] In one embodiment the lancet is configured to adopt a standby position in which the lancet includes at least a piercing portion that extends from the housing and a spent position in which the piercing portion is wholly retracted within the housing. The lancet is configured to adopt the spent position after piercing a membrane of a testing patient.

[0013] In one embodiment the lancet is operatively mounted in the housing so that it extends into the cutout in the standby position.

[0014] In one embodiment the notch or cutout or bevel is disposed at an intermediate position along one edge of the housing.

[0015] In one embodiment the notch or bevel is disposed in a corner of the housing.

[0016] In one embodiment in the standby position the piercing portion of the lancet extends into the notch or cutout or bevel but does not extend past the edge of the housing so that the edge of the housing protects the piercing portion and users from bumping and damage and contact with the piercing portion.

[0017] In one embodiment the lancet includes a cover on the piercing portion for protection.

[0018] In one embodiment the buffer dock includes a floor which is shaped in any suitable way to facilitate ejection of buffer fluid from the buffer reservoir. The floor may be a concave shape, or tilted toward the outlet, and may include a channel to draw or lead the buffer out toward the outlet.

[0019] In one embodiment the buffer dock includes a knife extending from a wall or floor of the buffer dock to pierce the buffer reservoir when the reservoir is pressed.

[0020] In one embodiment the knife is a linear, rectangular, square, circular, conical or annular, and / or frusto-conical shape.

[0021] In one embodiment the knife includes a well inside to receive buffer fluid. In one embodiment the well includes an outlet to eject fluid and direct it to the outlet. In one embodiment the knife includes two or more side walls spaced apart to provide the outlet for the well.

[0022] In one embodiment the gallery includes a channel, a tube, a bridge, or any suitable hose or transfer structure.

[0023] In one embodiment there is a gallery for transferring the buffer to the mixing station inlet.

[0024] In one embodiment the gallery includes a floor on one portion of the housing and a cooperating roof and / or walls portion provided by a cooperating portion of the housing.

[0025] In one embodiment the blood collecting station includes a well in a concave shape to receive a finger pad.

[0026] In one embodiment the aperture is elongate in the bottom of the well.

[0027] In one embodiment the test strip is disposed under a results display aperture in the housing for ready display of results.

[0028] In one embodiment there are two or more testing stations.

[0029] In one embodiment there are two buffer docks and two mixing stations and two test beds, each independent of the other.

[0030] In one embodiment there is one buffer dock connected to a plurality of mixing stations connected via a gallery manifold.Brief Description of Drawings

[0031] So that the invention may be better understood, it will be explained further with reference to the attached drawings of an embodiment, and in those drawings:

[0032] Figure 1 is an exploded view of an integrated testing cassette showing lancet, test strip, buffer dock and sample window;

[0033] Figure 2 is an isometric view of the integrated testing cassette of Figure 1 showing the lancet covered by the protective lid, in the standby position, extending into a bevel on the comer of the cassette housing;

[0034] Figure 3 is an isometric view of the bottom shell of the cassette, showing the buffer reservoir in the buffer dock, and the lancet in the standby position with its cover on and the test strip in the testing zone;

[0035] Figure 4 is a bare base cassette shell, showing mounts for the lancet, for the testing strip, and showing the buffer reservoir dock;

[0036] Figure 5 is a partial section through the cassette through the fluid transport portion showing the buffer blister pack, and the rear wall of the gallery provided by the top shell of the cassette;

[0037] Figure 6 are various detail section views of the cooperating shells in the area of the buffer gallery, shown in three views - Figure 6a, Figure 6b and Figure 6c;

[0038] Figure 7 shows three views of the lancet mounts. Figure 7a is a plan view of the staggered interference fit mounts; Figure 7b is an isometric view of the lancet mounted within staggered 0.2mm crush ribs for secure mounting; and Figure 7c shows an isometric view of the base shell with the buffer reservoir, the lancet, and the test strip components mounted thereon, with the top shell being translucent for clarity;

[0039] Figure 8a and 8b are both isometric detail views of the buffer reservoir dock with buffer reservoir blister pack in place, and showing the knife and the buffer outlet;

[0040] Figure 9 is a plan detail view of the sample window aperture and the gallery inlet to the testing strip;

[0041] Figure 10 is a closer detail view of Figure 9 for more detail;

[0042] Figure 11 is an isometric view of a twin-testing station embodiment of the present invention, with the sampling station lance removed for clarity;

[0043] Figure 12 is a plan view of the device shown in Figure 11;

[0044] Figure 13 is a section view through Figure 12 at cut F;

[0045] Figure 14 is a section view through Figure 12 at cut G; and

[0046] Figure 15 is a section view longitudinally through a test bed showing the difference in height between the base of the buffer dock and the collection / mixing stations.Description of Embodiments

[0047] Referring to the drawings there is shown a blood testing device generally indicated at 10. There is also a blood testing device indicated at 110 which is a second embodiment. Like numerals denote like parts so 10 and 110 denote similar features between embodiments, for economy of description.

[0048] The device 10, 110 includes a housing 12, 112, in two shells 12a and 12b. The housing 12 includes a sampling zone 5, 105 and a testing zone 7, 107.

[0049] Each shell 12a, 12b is shallow in form. Overall each one is like a credit card form, being overall rectangular, with low side and end walls extending upward therefrom, to keep the form overall flat and efficient. This has consequences for the design of the galleries and the other components, as described hereinbelow.Sampling zone

[0050] The sampling zone 5, 105 at least partially houses a membrane piercing element 20, 120 which is a lancet 22,122 for piercing the skin (not shown) of a patient to release a sample of blood from the patient.

[0051] The sampling zone 5 of the housing 12 includes a notch 15 or cutout or bevel or a chamfer for presenting the lancet 22 to a user. The notch or cutout 15 is to maintain the lancet 22, 122 within the overall envelope of the housing 12. In this case the lancet 22 does not extend beyond the side or end walls of the housing 12.

[0052] The lancet 22 is configured to adopt a standby position in which the lancet includes at least a piercing portion 23 that extends from the housing and a spent position (not shown) in which the piercing portion 23 is wholly retracted within the housing 12 behind the bight edge wall 16 of the bevel 15. The lancet 22 is configured to adopt the spent position after piercing a skin or membrane of a testing patient. The lancet 22 moves inside the lancet housing between those positions. The operative mounting is shown most clearly in Figure 7, although there are other mounting arrangements shown in Figures 3 and 4. In Figure 7 can be seen the offset staggered friction mounts 24 and also the crushable 0.2mm ribs for frictional connection. The lancet is spring mounted to retract after one shot, as it were.

[0053] The lancet 22 is operatively mounted in the housing 12 so that it extends into the cutout 15 in the standby position, but not past the top edge 17, for its protection. The notch or bevel 15 is disposed in a corner of the housing for ease of use and protection of the lancet. Thelancet 22 includes a cover 28 on the piercing portion for protection which is removed to operate the lancet to pierce the skin of the patient.Testing zone

[0054] The testing zone 7, 107 includes a blood collection station 40, test bed 50, a mixing station 43 and a buffer station 30, the latter two connected together by a gallery 38.

[0055] The buffer station 30 is disposed in the housing 12 for docking a buffer reservoir 32. The buffer station 30 is a dock 31 and is disposed at the base of a well 33 in the housing and includes a fluid outlet 34 and a buffer reservoir cutter 35 disposed at the base of the buffer dock 31.

[0056] The buffer reservoir 32 is a blister pack so it sits in the well 33, and has a convex base and a convex roof as is normal of a blister pack.

[0057] The convex roof is intended to sit below or just slightly above the top wall of the housing 12. This saves on packaging and protects the blister pack so that it does not accidentally open before it is intended. The roof and base of the blister pack are foil, thin, so that it can be readily cut into by the knife cutter at the base of the well. The presence of the cutter at the base makes the flush location of the roof even more important or at least understandable; any pressure on it will open it up and pour buffer into the internals of the housing 12.

[0058] The blood collection station 40 includes an aperture 41 for transporting the blood for testing from the patient through the wall of the housing through to a mixing station 43. The aperture 41 of the blood collection station 40 is an elongate window 45 at the base of a finger well 42 in housing shell 12a.On the other side of the window 45 is the mixing station 43 for receiving blood from the well 42 and buffer from the reservoir 32.

[0059] The mixing station 43 is connected to the buffer dock 31 by the gallery 38 which extends between the mixing station 43 and the buffer station 30. The gallery 38 is closed on its sidesby walls 39 extending from shell 12a, and closed on the top and bottom by the top and bottom walls of the shell 12a and 12b, or by floor and wall elements parallel to those walls. The gallery floor 37 is a ramp that moves across slightly upward as it extends from a buffer dock outlet 34 to the mixing station inlet 36.

[0060] The reason that the gallery floor 37 extends upward is because the floor of the dock 31, the well 33, sits low in one shell 12. This is to reduce the height of the buffer reservoir 32 so that it substantially sits flush with the top wall of the housing.

[0061] Another reason the gallery extends slightly upward is to make the test bed 50 closer to the roof of housing 12a to make the results easier to see on a test strip 51, which is configured by being partially disposed therein, to receive the mixture of blood and buffer from the mixing chamber 43.

[0062] The test strip 50 structure is as set out below.

[0063] The LFA (lateral Flow Assay) Strip comprises four components: a sample pad, a conjugation pad, a polymeric nitrocellulose (NC) membrane, and an absorption pad, all of which are overlapped and installed sequentially on a plastic backing card.

[0064] Sample Pad: This component ensures that the analyte in the sample can bind to the conjugation reagents and the membrane.

[0065] Conjugation Pad: This pad contains the labelling reagent (e g., an antibody-conjugated) in a dried form. The labelling reagent is rapidly released when the sample comes into contact with the pad.

[0066] Nitrocellulose Membrane: This porous membrane is where the antibodies are striped in lines. It contains target antibodies or antigens that are immobilized, allowing for a reaction with the conjugated antibody / antigen bound to the analyte. The recognition of the sample analyte results in a visible response on the test / target line, while the control line indicates proper liquid flow through the strip.

[0067] Wick / Absorbent Pad: This pad helps control the flow of the sample along the strip 50.Buffer

[0068] The buffer reservoir is a blister pouch that contains a sample buffer liquid that facilitates the movement of an analyte of interest across various zones of polymeric stripssolely through capillary action, without the need for external forces. The sample buffer consists of salts and surfactants, ensuring that the sample is suitable for interaction with the detection system.

[0069] The buffer dock 30 includes a floor 31 which is shaped in any suitable way to facilitate ejection of as much fluid as possible from the buffer reservoir. So, the floor is a concave shape, tilted up toward the outlet, and which includes a channel 71 to draw or lead the buffer out toward the outlet 34. The buffer dock 30 includes a knife 35 extending from the floor 31 of the buffer dock 30 to pierce the buffer reservoir 32 when the reservoir 32 is pressed. The knife 35 is an annular, frusto-conical shape and includes a well 75 inside to receive buffer fluid. The well 75 includes an outlet 77 to eject fluid and direct it to the outlet 34.

[0070] Finally, the test strip 51 is disposed under a display aperture 55 in the housing for ready display of results.IN OPERATION

[0071] So, to use, the user removes the cover 28 of the lancet 22 and pushes their finger on the lancet 22. Then the lancet 22 pierces the skin and is then spent and retracted. Then the patient places the drip of blood from their finger on the blood collection station 40. The blood flows into the mixing chamber 43 and saturates a proximal end of the testing strip 50.

[0072] Then the patient presses the buffer reservoir 32 and the knife 35 pierces the reservoir 32. The squeezing of the blister pack of the buffer forces the buffer upward through the gallery 38 to the mixing chamber inlet 36 and onto the mixing chamber 43. The buffer and blood saturates the proximal end of the testing strip 51. Then the mixture flows along the strip 51 and the test results are read in the window 55.ADVANTAGES

[0073] The shells and the disposition of the wells and the galleries present a compact solution that presents accurate results with a compact form. The design is flat and shallow.

[0074] Despite the shallow form, the elements are protected within the shallow form, behind the walls of the housing.

[0075] It will be understood to persons skilled in the art of the invention that many modifications may be made without departing from the spirit and scope of the invention.

[0076] It is to be understood that any prior art publication referred to herein does not constitute an admission that the publication forms part of the common general knowledge in the art.

[0077] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS:

1. A blood testing device including: a housing including spaced apart walls, the housing including a sampling zone and one or more testing zones; the sampling zone including: a membrane piercing element disposed at least partially in the housing, the membrane piercing element being a lancet for piercing a membrane of a patient to release an amount of blood from the patient; the or each testing zone including: one or more buffer stations, the or each buffer station including: a buffer dock for docking a buffer reservoir, the buffer dock disposed at least partially in the housing and including a fluid outlet; a buffer reservoir disposed in the buffer dock; a buffer reservoir cutter for cutting the buffer reservoir; one or more mixing stations, the or each mixing station including: a mixing chamber in an interior of the housing including a mixing chamber inlet; a blood collection station including an aperture disposed in a top wall for receiving the blood from the patient therethrough from outside the top wall to the mixing chamber; a buffer transfer gallery disposed between the or each buffer station fluid outlet and one or more of the mixing station inlets; and one or more test beds extending from the one or more mixing chambers, wherein a test strip is disposed on the test bed and at least partially in the mixing chamber for receiving the mixed blood and buffer, and displaying a test result on a result portion.

2. The blood testing device in accordance with claim 1 wherein the housing is rectilinear, round, or cylindrical.

3. The blood testing device in accordance with claim 1 or 2 wherein the housing includes a cassette-shaped device which is a low, flat rectangle.

4. The blood testing device in accordance with any one of the previous claims wherein the sampling zone portion of the housing includes a notch or cutout or bevel or a chamfer for presenting the lancet to a user.

5. The blood testing device in accordance with any one of the previous claims wherein the lancet is configured to adopt a standby position in which the lancet includes at least a piercing portion that extends from the housing and a spent position in which the piercing portion is wholly retracted within the housing.

6. The blood testing device in accordance with any one of the previous claims wherein the lancet is operatively mounted in the housing so that it extends into the cutout in the standby position.

7. The blood testing device in accordance with any one of the previous claims wherein the notch or cutout or bevel is disposed at an intermediate position along one edge of the housing.

8. The blood testing device in accordance with any one of the previous claims wherein the notch or bevel is disposed in a corner of the housing.

9. The blood testing device in accordance with any one of the previous claims wherein in the standby position the piercing portion of the lancet extends into the notch or cutout or bevel but does not extend past the edge of the housing so that the edge of the housing protects the piercing portion and users from bumping and damage and contact with the piercing portion.

10. The blood testing device in accordance with any one of the previous claims wherein the buffer dock includes a floor which is a concave shape, and includes a channel to draw or lead the buffer out toward the outlet.

11. The blood testing device in accordance with any one of the previous claims wherein the buffer dock includes a knife extending from a wall or floor of the buffer dock to pierce the buffer reservoir when the reservoir is pressed.

12. The blood testing device in accordance with any one of the previous claims wherein the knife is a linear, rectangular, square, circular, conical or annular, or frusto-conical shape.

13. The blood testing device in accordance with any one of the previous claims wherein the knife includes a well inside to receive buffer fluid.

14. The blood testing device in accordance with any one of the previous claims wherein the well includes an outlet to eject fluid and direct it to the outlet.

15. The blood testing device in accordance with any one of the previous claims wherein the knife includes two or more side walls spaced apart to facilitate fluid flow to the outlet.

16. The blood testing device in accordance with any one of the previous claims wherein the gallery includes a floor on one portion of the housing and a cooperating roof and / or walls portion provided by a cooperating portion of the housing.

17. The blood testing device in accordance with any one of the previous claims wherein the blood collecting station includes a well in a concave shape to receive a finger pad.

18. The blood testing device in accordance with any one of the previous claims wherein the aperture is elongate in the bottom of the well.

19. The blood testing device in accordance with any one of the previous claims wherein the test strip is disposed under a results display aperture in the housing for ready display of results.

20. The blood testing device in accordance with any one of the previous claims wherein there are two or more testing stations.

21. The blood testing device in accordance with any one of the previous claims wherein there are two buffer docks and two mixing stations and two test beds, each independent of the other.

22. The blood testing device in accordance with any one of the previous claims wherein there is one buffer dock connected to a plurality of mixing stations connected via a gallery manifold.

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