CN1845704A - Sampling device with capillary action - Google Patents

Abstract

The present invention provides a device for receiving a sample of liquid, such as a sample of bodily liquid which is to be subjected to further analysis. The device comprises a body having at least a major surface and a minor surface. A sample-receiving chamber is located in the body and has an inlet end which opens into the major and minor surfaces of the body. A conduit is located in the body, extends from the outlet end of the chamber, and is arranged so as to allow the liquid to pass from the outlet end into the conduit by capillary action.

Description

Has capillary sampler

The present invention relates to be used to receive the device of fluid sample, especially, yet and non-exclusively, the present invention relates to be used to receive body fluid such as blood sample so that the device that can test this sample.

Known blood sugar monitoring very rapidly absorbs with the fluid sample receiving system and refers to sting blood, and this does not become problem at present, does not move blood or does not require by capillary-driven blood because the present measuring method of taking requires with active mode.

Yet, refer to sting the problem that blood sampling exists requiring sample to use be moved or require with the diagnostic equipment of capillary-driven sample with active mode in.

In first aspect, the invention provides the device that is used to receive fluid sample, this device comprises:

At least the main body that has first type surface and subsurface;

Sample receiving chamber, it is positioned at main body and has the arrival end of opening at main body first type surface and subsurface; With

Conduit, it is positioned at main body and extends from the port of export of sample receiving chamber, and this conduit is arranged so that liquid enters conduit by capillarity from the port of export.

The present invention allow the user with fluid sample the sample receiving chamber place be deposited in the device or device on.The user can remove sample source (for example finger), and described device guarantees that liquid supplies along conduit downwards, for example, makes test to carry out in another zone of device.When not producing result of the test immediately, this mode is important for the blood sample diagnostic equipment, and for example immunoassay require reagent that the immunity combination takes place or measure relevant biological enzyme reaction with clotting time.For wherein diagnosing or test the device no less important of having to when carrying out away from the sample receiving chamber place.Another advantage is the effect that sample receiving chamber plays liquid reservoir, its then can in addition when the user does not keep in touch with device to all the other samples of device provisioning, and eliminated and in filling process, require user and device to keep the constant needs that contact.This is for old people's advantageous particularly, should be old people and may find to be difficult to and may be that undersized device keeps constant and contacts.And it has reduced when at any time remove liquid source during filling and causes underfill or introduce bubble and the probability of generating means fault.

Described chamber can be used for such device, and the filling time of this device only is presented to fluid supply the time of removing fluid supply on the device then greater than the user, and for example, the filling time is one second or longer.

Device of the present invention can be for chemistry (the particularly biochemical or clinical) device that process of the test is used, and is commonly referred to capillary tube filling test device.Capillary tube filling test device is united use with second device usually, described second device is generally existence that is designed for one or more analytes in tracer liquid sample or the fluid sample or the electronic machine of being scheduled to interactional degree, and it has one or more miscellaneous parts of described device.Described parts may be electrode structure and/or one or more and liquid is interactional or with the composition of analyte reaction.Electronic machine can be used to the sample liquids in the evaluation device, is to use optical measurement techniques or Electric Measurement Technology at predetermined example reaction after date the most representatively.The capillary tube filling device often is designed in device carry fluid sample anteposition in electronic machine.When the capillary tube filling device suitably is arranged in instrument, sample receiving chamber is positioned at the outside of instrument and can be reached by the user, the zone of testing of this device and sensing element arrange in the mode of electric communication or printing opacity/reflective communication, described sensing element can detect and report preset after the period or preset the period during the state or the state of liquid change.A large amount of test(ing) liquids are delivered to sample receiving chamber by the traction of capillarity (and power of possible other), and enter and pass through conduit, and the zone of testing of access to plant.Described instrument can be equipped with pick off, is used to detect test(ing) liquid flowing by conduit; Randomly, described instrument can be designed to use this detected flowing with the beginning test procedure.In some liquid pilots are used, for example, use in the instrument of measuring the blood clotting feature thereby be designed for the capillary tube filling device at some, the rate of discharge of liquid by the capillary flow conduit is detected and as the parameter in the test procedure.In above-mentioned test was used, conduit additionally was used to be provided for the mechanism of the flow behavior viscosity of experiment with measuring liquid when it is delivered to pilot region.

Device main body can be straight line bar shaped substantially, and this is the conventional pattern that is used for capillary test devices.These bars can have the uneven each other part of end wall, sidewall and/or top surface and basal surface or its.Perhaps, it can be cylindrical, wedge shape, disc or any other shape easily, and condition is that it has the wherein arrival end opening first type surface and the subsurface thereon of sample receiving chamber.

The arrival end opening of sample receiving chamber is at the main outer surface and time outer surface of main body.First type surface and subsurface can be perpendicular to one another usually, and the surface area of subsurface can be significantly less than the surface area of first type surface.Subsurface can be end wall or sidewall, and first type surface can be top surface (when for example main body is straight line lines or wedge shape or disc), and in this case, first type surface can not be thought in the side of device.In one embodiment, subsurface is an end wall, and first type surface is outer surface (when for example main body when being cylindrical).The shape of tube body is not how, and the opening of arrival end is successive in first type surface and subsurface preferably.

The opening of sample receiving chamber may be less than the opening of the sample receiving chamber part at first type surface in the part of subsurface.For example, the opening of sample receiving chamber can be its opening 1.3 to 3 times at the area of subsurface at the area of first type surface, in one embodiment, is 1.6 times.

Sample receiving chamber can be tapered to the port of export from arrival end, and can be substantially V-arrangement or U-shaped.For example, about 10-15 that the width of arrival end can be port of export width doubly, and can be the sample reception part length 0.5-1.5 doubly.

Catheter design although other power can act on liquid, as hydrostatic pressure and/or positive displacement, makes liquid move along conduit for making fluid sample to move by capillarity.For example, when when observing perpendicular to the section of the longitudinal axis, the full-size of conduit can be less than 0.5,0.4 or 0.3mm.In one embodiment, full-size is 0.25-0.3mm, and can be about 0.28mm.The Reynolds number of conduit can be less than about 200, and this numeral is calculated according to following formula:

$\mathrm{Re}=\frac{\mathrm{\ρVd}}{\mathrm{\η}}$

Wherein, Re=Reynolds number, ρ=fluid density, V=fluid velocity, d=length scales, η=dynamic viscosity.Reynolds number be 200 or more the young pathbreaker cause that conduit (it can be considered to microstructure or microchannel) carries out passive type by independent surface tension (capillarity) and fills.

At least sample receiving chamber and conduit scribble hydrophilic coating easily, and coating can be positioned on any or all wall.The available contact angle of coating is 90 ° or still less, 30 ° or still less, or 20 ° or still less.Contact angle can be 5-15 °, and can be 11 °.110 ° contact angle can be provided, and condition is that it only is administered to a wall.The description of contact angle measuring method is referring to " Fundamental andApplications of Microfluidics ", Nguyen ﹠amp; Werely, Artech House, 30Sept 2002,1580533434, the 46 pages of ISBN.

The liquid that can take a sample is any liquid.In preferred embodiments, liquid is body fluid, as whole blood, blood plasma, tissue fluid, cerebrospinal fluid (CSF), urine, serum, saliva, tear and perspiration.

In second aspect, the invention provides the device that is used to receive fluid sample, this device comprises:

At least the main body that has end wall;

V-arrangement sample receiving chamber substantially, it is positioned at main body and has the arrival end of opening at the main body end wall; With

Conduit, it is positioned at main body and extends from the port of export of sample receiving chamber, and this conduit is arranged so that liquid enters conduit by capillarity from the port of export.

Device of the present invention can be used for receiving the blood that the experience blood coagulation is measured and/or other hemostasis measurements are measured as prothrombin time.They also can be used for receiving the body fluid of experience immunoassay, hormone measurement, the measurement of cardiology label, the measurement of cancer label, infectious materials measurement etc.These tests can be carried out in the analysis room of device.

The preferred feature of each side of the present invention is for the in addition necessary change of the preferred feature of other each side.

The present invention will be described further with reference to the accompanying drawings, wherein:

The part axonometric chart of Fig. 1 one embodiment of the invention;

Fig. 2 is the plane graph of Fig. 1 device;

Fig. 3 is the cutaway view of Fig. 2 along the X-X line;

Fig. 4 is the axonometric chart of Fig. 2 along the section of X-X line;

Fig. 5 a and Fig. 5 b are the plane graph of two alternative embodiment of the present invention;

Fig. 6 for the filling time-join the curve chart of the volume of whole blood in apparatus of the present invention;

Fig. 7 is the part axonometric chart of the front end of another embodiment of the invention;

Fig. 8 is the plane graph of Fig. 7 device; With

Fig. 9 is along the cutaway view of X-X line among Fig. 8.

With reference to figure 1-4, partly show device 1.Device 1 has surface, top (master) 2, end (inferior) surface 3 and each side 4.Can not see the basal surface of device.Device 1 is tapered towards end surfaces.In some embodiments, device 1 is this tapered shape not, and in other embodiments, device 1 has hammer-shaped.Sample receiving chamber 5 is recessed in device 1, makes its opening at top surface 2 and end surfaces 3.In embodiment optionally, sample receiving chamber 5 openings are at top surface 2 and side surface 4.

Sample receiving chamber 5 has arrival end and leads to the port of export of conduit 6.Arrival end is in fact greater than the port of export, makes sample receiving chamber 5 be tapered with V-arrangement towards the port of export.Perhaps, sample receiving chamber is V-arrangement substantially or the U-shaped shown in Fig. 5 a and the 5b.In one embodiment, sample receiving chamber 5 is tapered, and makes the value of size A reduce from the arrival end to the port of export.Usually, sample receiving chamber can be Any shape and size, as long as fluid sample can enter the port of export from arrival end by capillarity.In order to quicken liquid in indoor the passing through of sample reception, the shape and size of sample receiving chamber are chosen as and make the capillarity at port of export place greater than the capillarity at arrival end place.

As shown in the figure, conduit 6 is at the recessed raceway groove of top surface 2.Although not shown, conduit 6 is closed by the thin layer that is placed on the top surface 2.This layer can cover the whole of sample receiving chamber 5 or it is a part of, although not preferred this layer covers the whole of sample receiving chamber 5, because the other friction that provided by this floor on the chamber 5 has reduced the speed that liquid can move down along conduit 6, it is favourable that the part of sample receiving chamber 5 is capped, when sample administration arrives sample receiving chamber, should cover the surface tension of destroying sample, and help sample to enter conduit 6.Part covers and also makes the sample volume that adds greater than the volume that can add in sample receiving chamber.The other end of conduit 6 leads to the regional (not shown) of analyzing or testing of device.

In one embodiment, size A is 0.9mm, and B is 2.5mm, and C is 0.2mm, and D is that 3mm and E are 0.2mm.

Device of the present invention can use various technology preparations known in the art.For example, can use the injection molding or the microinjection method of molding of suitable mould.Perhaps, also can use the stamping technique and the technology of using silicon etching and/or photolithography that the structure embossing is become described material.

As another replacement scheme, this device can pass through the two-layer or more multi-layered preparation of lamination, and referring to Fig. 7, this device can comprise three layers.Basal layer 7 forms the bottom surface of chamber 5 and raceway groove 6.Thereby intermediate layer 8 has the wall that the otch that runs through it forms chamber 5 and raceway groove 6.Top layer 9 forms the top surface of raceway groove 6.In the embodiment of graphic extension, top layer 9 partly covers sample receiving chamber 5, and it is formed by the cut sides of layer 8 and the top surface of basal layer 7.The plane graph of Fig. 7 is shown in Figure 8, and the cutaway view along the X-X line of Fig. 8 is shown in Figure 9.

In one embodiment, size A is 0.275mm, and B is 3mm, and C is 0.3mm, and D is 2.5mm, and E is that 0.175mm and F are 2mm.

Laminater of the present invention can be by UK Patent Application 0327094.9 described method preparation, and it discloses incorporated herein by reference.

Embodiment

Injection-molded polystyrene devices, it has the sample receiving chamber shown in Fig. 1-4.These devices are handled with the plasma-enhanced chemical vapor deposition method then, thereby to surface-coated hydrophilic molecule layer, make that the contact angle after handling is about 11 °.Above-mentioned technology is known for those skilled in the art.To device lamination hydrophilic thin layer (contact angle is 11 °), make thin layer cover conduit 6, but do not cover sample receiving chamber 5 then.

The fresh whole blood of different volumes is pipetted into (blood that also can refer to the bundle source is applied directly to sample receiving chamber) on the sample receiving chamber 5.Measurement blood is moved down into the time of fixing point along conduit 6.The curve chart of described filling time-join volume of whole blood in the device as shown in Figure 6.

Can find out that 5 μ l or littler volume cause the filling time greater than about 20 seconds, 7 μ l or bigger volume are less to the influence of filling time.

Claims (9)

1. be used to receive the device of fluid sample, this device comprises:

At least the main body that has first type surface and subsurface;

Sample receiving chamber, it is positioned at main body and has opening at the first type surface of main body and the arrival end of subsurface; With

Conduit, it is positioned at main body and extends from the port of export of sample receiving chamber, and this conduit is arranged so that liquid enters conduit by capillarity from the port of export.

2. the described device of claim 1, wherein the opening of the arrival end of sample receiving chamber is successive in first type surface and subsurface.

3. claim 1 or 2 described devices, wherein main body is substantially straight line bar shaped or wedge shape or disc.

4. the described device of claim 3, wherein subsurface is the end wall or the sidewall of main body, first type surface is the top surface of main body.

5. claim 1 or 2 described devices, wherein main body is substantially cylindrical.

6. the described device of claim 5, wherein subsurface is an end wall, first type surface is the outer surface of cylinder.

7. each described device in the aforementioned claim, wherein sample receiving chamber is tapered to the port of export from arrival end.

8. the described device of claim 7, wherein sample receiving chamber is substantially V-arrangement or U-shaped.

9. be used to receive the device of fluid sample, this device comprises:

At least the main body that has end wall;

V-arrangement sample receiving chamber substantially, it is positioned at main body and has the arrival end of opening at the main body end wall; With

Conduit, it is positioned at main body and extends from the port of export of sample receiving chamber, and this conduit is arranged so that liquid enters conduit by capillarity from the port of export.

Images