WO2013000357A1

WO2013000357A1 - A device for collecting fluid samples

Info

Publication number: WO2013000357A1
Application number: PCT/CN2012/076441
Authority: WO
Inventors: Yinan ZHAN; Lijian Gou; Haipeng Hu; Fuquan Zhao
Original assignee: Abon Biohparm (Hangzhou) Co., Ltd
Priority date: 2011-06-30
Filing date: 2012-06-04
Publication date: 2013-01-03
Also published as: CN102854034A

Abstract

This invention relates to a device for collecting fluid samples, comprising a collecting part and an electronic unit which at least comprises two electrodes and processors, wherein the electrodes contact the collecting part and the electronic unit can control and regulate the collected sample volume. This device can collect enough samples for test or assay; or the rest sample can be used for the second test. Also, this collecting device can simply indicate the collected fluid is enough by a clear signal. The device is simple to operate and convenient to produce with higher efficiency during practical operation.

Description

A device for collecting fluid samples

Field of the invention

This invention relates to the field of devices for collecting fluid samples, especially saliva, indicating the quantity of collected samples.

Background of the invention

Common devices for collecting fluid samples, especially saliva, comprise a collecting head and a collecting handle, such as the collecting device of Varian described in the patent US 6,489, 172 B l . The sample is obtained when the collecting head is put into the mouth of subjects, and then used for all assays in testing devices. These devices can collect samples simply and quickly, but they have some disadvantages: as the saliva-collecting part gradually becomes soft, the saliva easily flows back when this part is squeezed by foreign force. If the collecting device contains some chemical indicators, the returned fluid may contaminate the saliva to be tested.

Some collecting devices like these described in the patent US 7, 114,403 B2 can be used for collecting, storing and even testing samples. The collecting part comprises a handle and a collecting head that is made of sponge or any other water absorbent materials. The collecting head is put into the mouth of the subject for a while, taken out and placed into the sample storage component, and squeezed to transfer the fluid from the head into the storage component.

Another device for collecting saliva samples such as the one described in the patent 6,998,273 B l combines the collecting function with testing function. A movable "fence" device is arranged between the collecting part and the testing part to avoid the impact of sample reflux during test on the test result and the health of the subjects. The "fence" device could be considered as a switch communicating the sample with the test area for the next test after the sample is collected.

Conventional devices for collecting saliva cannot determine if the collected sample is enough, especially when applied to collection of saliva for drug detection. The disturbing problem has the following reasons: firstly salivary gland often needs to be stimulated for more saliva as saliva is not abundant like urine, and moreover drug addicts are usually very thirsty; secondly the drug users are resistant to be determined as drug addicts, so the drug detection may fail for insufficient samples. Therefore we expect to collect more saliva sample for normal detection.

In addition, the fluid sample to be tested is expected to be within a range, for example 0.1-0.5 mL in some tests. A more precise range shall be controlled as too much or too little sample may affect the precision of test results. In some cases, operators can easily obtain much fluid sample, but the test only needs a little volume. For this reason, the fluid sample shall be controlled as little as possible.

Summary of the invention

This invention provides a collecting device which can solve above problems by controlling or regulating the collected quantity of samples to avoid collecting too much or too little fluid. Good control of sample volume can meet required sample quantity or volume to ensure smooth test of next procedure.

The device provided in the invention comprises a collecting part and electronic unit that can be used to control or regulate the quantity of collected sample. Preferably, the electronic unit further comprises electrodes and processors. In some more detailed embodiment, the electronic unit at least has 2 electrodes which contact the collecting part.

In an embodiment, the electronic unit further comprises a power supply that provides certain voltage for electrodes, leading to certain potential difference between electrodes. In the absence of fluid, no electricity exists between electrodes, which is taken as an infinitely large resistance between the electrodes. In the presence of fluid samples, the potential difference between electrodes enables ions to move from high potential (one electrode) to low potential (another electrode), so the micro-current forms a micro-current circuit. The more sample (i.e. the more ions in the sample) is collected, the more ions move. Increasing current gradually reduces the resistance between electrodes. When the resistance decreases to a certain value (the resistance can be reduced to 0 in theory, but all samples actually have certain resistance, so the minimum resistance is the sample' s resistance), i.e. certain current, the current loop forming with current passing. When the electrodes are conducted, signals from the processor can be transmitted, indicating that certain volume of fluid is collected. Therefore, the electrodes contact the sample and are conducted if sufficient fluid sample is collected in the collecting part. Signals are generated as the conducted current passes through the processor, indicating certain volume of sample are collected in the collecting part.

In a preferred embodiment, the electronic unit can control and regulate the quantity of collected sample. In a detailed embodiment, the electronic unit provides variable power, i.e. variable voltage, to regulate the volume of collected sample. In a more detailed embodiment, the voltage varies inversely with the quantity of collected sample, i.e. lower voltage with more fluid; while higher voltage with less fluid.

In another preferred embodiment, the electronic unit control and regulate the sample quantity by the resistance. In a more detailed embodiment, the resistance varies directly with the quantity of collected sample, i.e. larger resistance with more fluid; in contrast, smaller resistance with less fluid.

In another more preferred embodiment, the electronic unit can control the quantity of collected sample by both voltage and resistance.

In a detailed embodiment, an adjustable resistor is connected to electrodes in series to collect more fluid samples. The electrodes connected to the adjustable resistor have lower sensitivity, but higher stability, thus regulating the volume of collected sample in a more stable manner. A resistor is considered between two electrodes. With the fluid sample contacting the electrodes, the resistance between electrodes becomes smaller with more fluid. The electrodes are conducted if the resistance is reduced to an extent. At the same voltage, a resistance smaller than that before the resistor is connected serially between the electrodes is needed to keep the same current when the electrodes are conducted (i.e. the minimum loop current for the processor generating signals), so more ions are needed to decrease the resistance between electrodes. Therefore, more fluid sample shall be collected for more ions. In this way, a little sample may not conduct the electrodes and lower the sensitivity of electrodes, so more quantity or volume of fluid sample can be collected.

We can understand that the quantity of collected fluid sample can be controlled by the voltage if the resistance is unchanged. For example, we set a voltage VI at beginning and another voltage V2 as the fluid conducts the electrodes in the electronic unit (V2 higher than VI). With the same resistance, fewer ions in the fluid sample are needed to keep the same current when the electrodes are conducted (i.e. the minimum loop current for the processor generating signals). At this time, the volume or quantity of collected fluid sample is smaller than that at voltage VI , thus limiting the fluid sample in a small range. On the contrary, the volume of fluid sample can be increased by the voltage. For instance, we can set a voltage VI at beginning and another voltage V2 as the fluid conducts the electrodes in the electronic unit (VI higher than V2). With the same resistance, more ions in the fluid sample are needed to keep the same current when the electrodes are conducted (i.e. the minimum loop current for the processor generating signals). In this case, the volume or quantity of collected fluid sample is larger than that at voltage VI, thus relatively increasing the collected fluid sample.

In an embodiment, the collecting part comprises two ends. Preferably, the electrodes contact one of the ends; the fluid flows to the end contacted with the electrodes when the collecting part absorbs the sample.

For the sample evenly distributed and enough fluid collected in the collecting part, the electronic unit can be arranged with a plurality of electrodes which are evenly placed in the collecting part. In a detailed embodiment, 5 electrodes are arranged in the electronic unit.

In a detailed embodiment, three of the five electrodes are respectively connected to an adjustable resistor regulating the volume of collected fluid. These resistors firstly lower the sensitivity of electrodes and then control the quantity of fluid sample by adjusting the resistance. Another electrode is used as the power supply and the rest one is taken as the grounding terminal. In a preferred embodiment, the grounding terminal electrode is controlled by MOS tube.

In a preferred embodiment, the resistance of these resistors is between l-8Mohm.

In an embodiment, the electronic unit further comprises a signal element which is connected to the processor for indicating the quantity of collected sample. In a detailed embodiment, the signal element is LED. The LED emits light when the loop current formed between the conducted electrodes passes the LED after passing the processor. Therefore, the emitting light from LED shows the electrodes are conducted and the collected fluid sample reaches the required quantity.

All elements in the electronic unit can be directly or indirectly connected by a plurality of ways, such as line connection and integrated connection. In a preferred embodiment, all elements in the electronic unit are integrated.

In some embodiment, the collecting device further comprises a handle or rod. Preferably, the handle or rod consists of three parts: front, middle and end.

In some embodiments, the collecting device further comprises a light-emitting element, indicating the quantity of collected fluid sample.

In some embodiments, the emitting light transmits from the front to the end of the handle or rod, or the light in the front makes the whole handle or rod luminous, which means that observers can see the whole handle or rod glow, or the end of handle or rod glow. For this reason the handle or rod should be made of transparent materials. In a more preferred embodiment, a cavity is designed for the handle or rod, so the light in the front can be transmitted to the whole handle or rod, or transmitted to the end of handle or rod by the cavity.

In some cases, the bright light at the front of handle or rod needs to transmit to and display at the end of handle or rod. In some detailed embodiments, a special reflective structure is designed at the end of handle or rod; in a more detailed embodiment, the reflective structure at the end of handle or rod has grooves, such as the shape of corrugation or fan; in another detailed embodiment, the reflective structure at the end of handle or rod has concave-convex spots and folds which create a coarse surface; and in a preferred embodiment, both the grooves and concave-convex spots are designed for the end of handle or rod.

These grooves, concave-convex spots and folds form many sections at the end of handle which are not parallel or crossed. Therefore the sections can reflect and refract the light at the end from the front of handle or rod many times. When reaching the end of handle, the light is reflected and/or refracted by the sections. For the plenty of unparallel sections, one section reflects and/or refracts the light to another or more sections which reflect and/or refract the light again. Thus the quantity of light is increased at the end of handle or rod by reflection and/or refraction, and consequently more reflected and/or refracted light can reach the eyes of observers, who can find the signals more easily. It means that the observers can feel brighter light at the end of handle or rod.

Light loss should be maximally avoided during transmission to ensure the quantity and intensity of light, i.e. minimum refraction, even all reflection of the light during transmission. In a preferred embodiment, the handle or rod is made of transparent materials, but the front or middle thereof is covered with a layer of opaque materials; in another preferred embodiment, the front and the middle of handle or rod is made of opaque materials, but the end thereof is made of transparent materials; and more preferably, a cavity is designed for the handle to transmit the light.

In a detailed embodiment, a cavity is arranged in the front of handle or rod, containing the electronic unit. A special structure is designed for the handle end, i.e. fan-shaped grooves and/or concave-convex spots. A light source is created at the front of handle when the electronic unit generates signals (e.g. the light from LED of the electronic unit), transmitted to the end of handle or rod by the handle or rod, and reflected and/or refracted by a special structure to the eyes of operators. Therefore the operators can determine if he/she collects required quantity of fluid sample by observing the light from the handle end.

In another embodiment, the handle or rod is connected to the collecting part, and specifically the front of handle or rod is connected to one end of the collecting part. In a more detailed embodiment, the handle or rod containing the electronic unit is connected to the collecting part, and moreover the electrodes of electronic unit contact the collecting part.

In an embodiment of this invention, one end of the collecting part is arranged with a retainer to ensure stability of collected sample volume; preferably, the retainer is positioned at one end of the collecting part which does not contacts the sample; and in another preferred embodiment, the inner diameter of retainer is the same as the outer diameter of the collecting part.

In another embodiment, the retainer is not higher than the half of collecting part.

In a detailed embodiment, the retainer is arranged at the place where the collecting part connects the electronic unit; preferably, the handle thereof is also connected to the retainer; and more specifically, the retainer is combined with the handle into a whole.

In a preferred embodiment, the electrodes of electronic unit are located in the collecting part, and the retainer on the collecting part is as high as the electrodes in the collecting part. In this invention, test elements can be arranged in the handle of collecting part and connected to the collecting part. The collected sample flows to the test elements for testing. In a detailed embodiment, the test element is a strip.

Benefits

This device in this invention can collect enough needed fluid sample for test or assay; or the rest sample can be used for the second test. In addition, this collecting device can simply indicate enough fluid is collected by clear signals. The device is simple to operate and convenient to produce with higher efficiency during practical operation.

Brief description of the drawings

Fig. l is a schematic view of connecting the collecting part with the electronic unit in an embodiment of this invention.

Fig. 2 is a schematic circuit diagram of the electronic unit in this invention.

Fig. 3 is another schematic circuit diagram of the electronic unit in this invention.

Fig. 4 is a conduction circuit diagram of the 5 electrodes of electronic unit in this invention.

Fig. 5 is the conduction diagram of the electrodes with adjustable resistors in this invention.

Fig. 6 is the conduction diagram of the grounding electrode of electronic unit in this invention.

Fig. 7 is the schematic view of an embodiment in this invention.

Fig. 8 is the exploded view of the device said in Fig. 7.

Fig. 9 is the exploded view (enlarged) of the partial structure of electronic unit said in Fig. 7.

Fig. 10 is the section of the device said in Fig. 7

Fig. 1 1 is the schematic view of the device in this invention from another perspective (in the handle end direction).

Fig. 12 is the schematic reflection and refraction view of the special structure of the device in this invention.

Fig. 13 is the schematic view of the light reflected and refracted by grooves at the handle end of the device in this invention.

Fig. 14 is the partial enlarged view and schematic view of the device said in Fig.13.

Descriptions of marks Collecting device 700; collecting part 100; one end of the collecting part 101 ; another end of the collecting part 102; electronic unit 200; electrodes 201 (J1,J2,J3,J4,J5); one end of the electrodes 201 1 ; another end of the electrodes 2012; processor 202; signal element (LED) 203; power supply 204; adjustable resistor Rl 205; handle 300; handle front 301 ; front cavity 3011 ; holding part of the handle (middle) 302; handle end 303; corrugated grooves 3031 ; concave-convex spots 3032; sticking plate 400; retainer 500

Description of the preferred embodiment

Structures or technical terms related in the utility model are further described as follows

Sample

The device of this invention can test any form of samples, including body fluid (e.g. urine, other body fluid and clinic samples). Liquid samples can be collected from solid or semi-solid samples including feces, biological tissues and food samples. These solid or semi-solid samples can be transferred into liquid samples by any method. For example, solid samples are mixed, broken, dipped soft, incubated, dissolved or decomposed by enzymolysis (e.g. water, phosphate buffer or other buffer). "Biological samples" can be collected from animals, plants and foods, including urine, saliva, blood, blood components, cerebrospinal fluid (CSF), vaginal swab, semen, feces, sweat, secretion, tissue, organ, tumor, culture of tissue and organ, cell culture and medium thereof (human or animals). For the electrolyte in these samples, the charges (ions) can move at certain voltage difference (potential difference). In addition, any sample as a substance has certain resistance (different samples have different resistances). All samples can be controlled or regulated in the collected quantity by variable resistances or voltages.

Analyte

The device of this invention can be used for analyzing any analyte. The device of this invention can be used for stable determination of the following examples (but not limited to them): human chorionic gonadotropin (hCG), luteinizing hormone (LH), folliclestimulating hormone (FSH), hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) and any abused drug. The analyte can be detected in any liquid or liquefied samples, e.g. urine, saliva, blood, plasma or serum. Other analytes include creatinine, bilirubin, nitrite, protein (non- specificity), blood, leukocyte, blood glucose, heavy metal, toxin and bacteria (e.g. protein and sugar of some specific bacteria such as escherichia coli 0157:H7, staphylococcus aureus, salmonella, Clostridium perfringens, Campylobacter, L. monocytogenes, vibrio parahaemolyticus or bacillus cereus). Any other analyte appropriate for side stream experiment can be assayed by this device. The analyte can also be contagious material or substances that indicate the infective stage. Analytes can also be drug (drug of abuse), hormone, protein, DNA, RNA, nucleic acid molecule and pathogen. Drug of abuse (DOA) refers to use of drug for non-medical purposes (often for nerve paralysis). Abuse of these drugs can lead to physical and mental damage, drug dependence, drug addiction and/or death. These drugs include cocaine, amphetamine (e.g. black beauties, white amphetamine tablet, dextroamphetamine, dextroamphetamine tablet and Beans), methamphetamine (crank, meth, crystal and speed), barbiturate (Valium®, Roche Pharmaceuticals, Nutley and New Jersey), sedatives (sleep auxiliary drug), lysergide (LSD), inhibitors (downers, goofballs, barbs, blue devils, yellow jackets and methaqualon), tricyclic antidepressants (TCA, i.e. imipramine, elavil and doxepin); phencyclidine (PCP), tetra-hydrocannabinol (THC, pot, dope, hash, weed and so on) and opiate preparations (morphine, opium, codeine, heroin and oxycodone). The test strip can also be used for detection of drug that is applied to medical use but is easy to overdose, such as tricyclic antidepressants (imipramine or the similar) and acetaminophen.

Test element

Horizontal test strips can be taken as test element for testing many analytes. Surely, other appropriate test strips can be applied in the invention.

Various test elements can be combined for this invention. One form of test elements is test strip. All forms of test strips can be used for analyzing analytes in samples (e.g. drug or metabolites reflecting physical conditions), such as immunoassay or chemical analysis. The test strips can be in the form of non-competitive or competitive analysis pattern, comprising absorbent material of a sample feeding area, a reagent area and a test area. The samples are added into the sample feeding area and flow to the reagent area by a capillary tube. The sample will combine with the reagent if the analyte exists in the sample, and then flow to the test area. For other reagents, the molecules of specifically binding analyte may be fixed in the test area. These reagents can react with the analytes in the samples (if present) and bind the analytes in the test area, or the analyte binds one of reagents in the reagent area, which indicates the marker for indicating signals is present in the reagent area or the separated marking area.

Assay

Assay means to test or detect if one substance or material is present, but not limited to this, e.g. chemicals, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, the organic tissue or organic tissue metabolites, nucleic acids, proteins or polymers. In addition, assay can also determine the quantity of substance or material. Furthermore, assay also includes immune detection, chemical detection, and enzyme assay and so on.

Collecting part 100

In some detailed embodiments, the fluid-collecting device comprises a collecting part 100 for absorbing the fluid sample. In a preferred embodiment, the collecting part 100 is mainly made of absorbent materials that can absorb the fluid sample by chemical absorption and store the absorbed sample. The material of the collecting parti 00 can be selected from one or a plurality of the following: polyvinyl alcohol (PVA), foamed plastic, resin, cross-linked sodium polyacrylate, acrylic acid-ethylene copolymer, polymerized and saponified matter of acrylonitrile, vinyl alcohol or sponge, filter paper, glass fiber, non-woven fabric and cellulose acetate. In a more preferred embodiment, the collecting part is made of foamed polyvinyl alcohol in any suitable shape such as cylinder, cuboid and cone. In a more detailed embodiment, for instance, the devices described in Fig. 7 and Fig 8, the collecting part 100 comprises two ends 101 and 102; the end

101 is used for collecting and absorbing the fluid sample into the collecting part 100; Or the end 101 of collecting part is put into a position to absorbing the fluid sample secreted by tissues or organs of the subject. For example, the end 101 of collecting part is put into the mouth of mammals or human to absorb the saliva; or the whole collecting part 100 is put into an organ such as the mouth to collect saliva. The other end 102 of collecting part connects the electronic unit 200 or contact partial elements of the electronic unit 200 directly or indirectly by other conductors. In a detailed embodiment, the end 102 of collecting part is connected to the processor 202 in the electronic unit 200 by the electrode 201 (as shown in Fig. 1). The fluid sample absorbed by the collecting part 100 gradually contacts and conducts the electrode 201 to create current which is transmitted to the processor 202, activating the electronic unit 200 to generate signals which indicate that enough fluid sample is collected, and remind of operators. More specifically, the processor 202 in the indicating device generates signals by the signal control element 203; these signals can inform the operator of status of the collecting part 100, who can determine to continue or stop sample collecting.

In another embodiment, as shown in Fig. 7-11 , the collecting part 100 is adhered to the handle front 301 by a sticking plate 400; the cavity 3011 contains the electronic unit 200 comprising two or a plurality of electrodes 201 formed by conductors; and one end 2011 of each electrode is directly connected to the end

102 of the collecting part 100 or directly inserted into the collecting part 100. These electrodes 201, the power supply 204 and the LED 203 (signal element) form a current circuit. As shown in Fig. 2, the LED 203 emits light to indicate the collecting part 100 collects enough fluid when any two or a plurality of electrodes 201 are conducted to form a current circuit. On the contrary, the LED 203 does not emit light if any two or a plurality of electrodes are not conducted to form a current circuit for lack of fluid, which shows the collected sample is not enough. The operator can stop collecting the sample when he/she see the light from the LED 203, i.e. collecting the required quantity of fluid sample. These electrodes 201 can be arranged in the processor 202. The LED 203, the battery 204 or other components can also be integrated on the processor 202 to form the electronic unit 200; the collecting part 100 is adhered to the processor 202 by the sticking plate 400, and connected to the electrodes 201. The circuit formed by the electrodes 201 , LED203 and battery 204 is as shown in Fig. 2. Certainly, they can be connected in any suitable manner as specifically described in the following.

In use of the collecting device 700 for fluid sample, the collecting part 100 absorbs the fluid sample and moistens the electrode 201 connected to end thereof. If the electrodes 201 are conducted by the fluid, the LED 203 emits light to indicate that the collecting part 100 collects enough fluid sample; otherwise the collected fluid is insufficient. Furthermore, the quantity of collected fluid sample can be controlled by the voltage supplied by the battery (power supply) 204 and the adjustable resistors in the electronic unit 200.

The collecting part 100 often becomes soft after absorbing the sample, especially when the softened part 100 is pressed by foreign force so that the quantity of collected sample is unstable. In an embodiment, a retainer 500 is designed for the collecting part 100 as shown in Fig. 10. In a detailed embodiment, the retainer 500 is arranged at one end of the collecting part 100. More specifically, the retainer 500 is positioned at the end which does not contact the fluid sample, i.e. the end 102 of the collecting part. The retainer 500 closely contacts the collecting part 100, which means the inner diameter of retainer 500 is the same as the outer diameter of collecting part 100. The height of retainer 500 is designed to ensure the quantity of collected sample. In common embodiments, the retainer 500 is not higher than the half of collecting part 100.

In a detailed embodiment, the collecting part 100 with the retainer 500 is connected to the electronic unit 200; specifically, the end 102 with the retainer 500 is connected to the electrodes 201 of the electronic unit. In an embodiment, the one end 2011 of electrodes is inserted into the end 102 with the retainer 500 of the collecting part. The retainer 500 contacts one end of electrodes in the collecting part 100 to prevent one end 201 1 of electrodes from contacting the sampling part resulted from dislocation of the collecting part 100, thus avoiding poor conduction of electrodes (even if the sample of required quantity is not collected, the electrodes 201 are conducted as contacting a large amount of sample). In a preferred embodiment, the retainer 500 is as high as the electrodes 201 in the collecting part 100.

In another detailed embodiment, if the connecting part 100 is connected to the handle 300, the retainer 500 is adjacent to the handle 300; furthermore, the retainer 500 can be connected to the handle 300. In a preferred embodiment, the retainer 500 and the handle 300 are combined into a whole. Electronic unit 200

In some detailed embodiments, the electronic unit 200 comprises the electrodes 201 connected to the collecting part 100, the processor 202, the electronic signal element 203 connected to the processor 202 and the power supply 204. The electronic signals are transmitted between all said components by conductors or semi-conductors. The pre-programmed soft and programmed circuit in the processor 200 can control the signal processing and response. For example, as the collecting part 100 collects certain quantity of fluid sample, the electrodes 201 in the collecting part 100 after contacting the fluid sample form a current circuit, activating the processor 202 to create an electronic signal. The created signal is transmitted to the electronic signal element 203 such as signal light which generates identification signals such as light or sound, indicating the preset quantity of fluid sample is collected. In a preferred embodiment, the collecting part 100 is at least equipped with 2 electrodes 201. The current after the two electrodes 201 are conducted at a preset voltage between the electrodes 201 activates the processor 202 to create an electronic signal which is transmitted to the signal element 203, generating identification signals that indicate the collected fluid sample is enough or full of the collecting part 100. The electronic signal element 203 can be connected to the processor 202 by a conductor such as wire, and the electrodes 201 can also be connected to the processor 202 by a conductor. In an embodiment of this invention, the electrodes 201 and the processor 202 are integrated.

In this invention, control or regulation of the quantity of sample collected by the collecting part refers that the collected volume reaches the preset requirement, i.e. the maximum or minimum volume or weight for some assays such as 0.5mL, 0.7mL, lmL, 5mL or 1- lOmL. The preset volume of sample refers to the collecting part fully or partially filled with the fluid. When the electrodes are conducted, the signal element (LED) indicates the collected sample is enough. Furthermore, increase or decrease of the voltage (power supply) 204 can speed up or slow down conduction of the electrodes 201 so as to control and regulate the quantity of collected fluid sample; or regulation of the resistance or serial connection of a resistor Rl (205) at the electrode can control the sensitivity of electrodes and the velocity of conducting electrodes, thus regulating the quantity of collected fluid sample. Moreover, we can set different voltages and/or resistances to control the quantity of all samples according to resistances thereof.

The electronic unit can only comprise the electrodes 201, the power supply 204 (button battery) serially connected to the electrodes, and the signal element 203 (LED). When the fluid sample flows into the collecting part 100 and contacts the electrodes 201 of electronic unit, the electronic unit 200 starts to work through the basic circuit as shown in Fig.2. In Fig. 2, the non-conducted electrodes 201 can be considered as an infinitely large resistor; while the resistance between the electrodes gradually becomes smaller when ions move from the high potential (one electrode) to the low potential (another electrode) under the potential difference between the electrodes 201 caused by the power supply 204 (V) after the fluid sample contacts the electrodes 201. After the fluid sample contacts the electrodes 201 in the electronic unit 200, the ions in the fluid sample move from high potential to low potential under the potential difference between the electrodes 201 to conduct the electrode 201, thus forming the current circuit as shown in Fig. 2. The conduction of current I also conducts the LED 203 which emits the light. The operator who sees the light can stop collecting the sample, i.e. the acquiring the required quantity of fluid sample.

Basic operation principle of the electronic unit 200 (I):

I=V/R

V refers to the voltage provided by the power supply 204; R refers to the resistance between two or every two electrodes 201.

The signal element 203 (LED) is conducted if I is equal to the conduction current of the signal element 203 (LED).

The current I pass through the signal element 203 emitting the light to indicate the collected sample is enough after two electrodes 201 are conducted; otherwise no light is emitted from the signal element 203, indicating the collected sample is inadequate.

Furthermore, variable power supply 204 needs correspondent resistor R between the electrodes 201 in the same conduction current for creating signals (i.e. the LED 203 emitting light). The resistance of electrodes 201 varies directly with the power supply 204 according to the formula (1). The principle can be applied to regulating the sample volume collected by the collecting part 100 in this invention. Lower power supply 204 needs smaller resistor between the electrodes 201 accordingly to obtain the set current I. Therefore, more ions (charges) in the fluid sample is required to reduce the resistance between the electrodes 201, which means that more fluid sample exists between two or every two electrodes, i.e. more fluid sample collected by the collecting part 100. In contrast, higher power supply 204 needs larger resistance between electrodes 201 correspondingly, so less ions between two electrodes can conduct the electrodes 201. Therefore, less fluid sample is required to form the current I for conducting the signal elements 203 (LED). For this reason, the power supply 204 varies inversely with the quantity of collected sample.

In a preferred embodiment, the electronic unit 200 can also control the quantity of collected sample by resistance. Except addition of an adjustable resistor into the electrodes, any methods of changing the resistance of circuit is practicable. In an embodiment, the circuit resistance can be regulated by the resistance of signal element.

In another preferred embodiment, the electrodes 201 are serially connected to the resistor Rl (205). The operation principle is as shown in Fig. 3. In this case, the operation principle of electronic unit 200 can be expressed by formula (2):

I=V/(R+R1)

V refers to the power supply voltage; R refers to the resistance between two or every two electrodes; and Rl refers to the resistance of resistor Rl (205)

The signal element 203 (LED) is conducted if the current I is up to the conduction current of the signal element 203 (LED).

If the current is up to the conduction current I of signal element 203 I (i.e. the minimum current value for the signal element emitting light) at the voltage of power supply 204, increasing resistor Rl (205) reduces the electrode resistor R 201 with constant V and I according to the formula (2); inversely, decreasing Rl (205) needs a larger electrode resistor R 201. Therefore, the quantity of collected sample can be controlled by addition of adjustable resistor Rl . If the adjustable resistor Rl (205) is increased, more irons (charges) in the sample are needed to reduce the resistor R, thus collecting more fluid sample. In contrast, a larger electrode resistor R is required if the adjustable resistor Rl (205) decreases according to formula (2), thus collecting less fluid sample. Consequently, less fluid sample is needed to conduct the electrodes 205. For this reason, the adjustable resistor Rl (205) varies directly with the amount of collected sample.

Generally, the fluid sample easily conducts the electrodes 201 due to the high sensitivity of the electrodes 201, especially when the collecting part 100 is pressed by sampling position (such as the pressure from the mouth when collecting saliva). The electrodes 201 after the collecting part collects certain sample are conducted to activate the LED 203 emitting light. A part of collected sample near the electrodes 201 may be scattered to other parts of the collecting part 100 when the collecting part 100 is taken away from the sampling position, which occurs more easily when the collecting part 100 is not full of the fluid sample. At this time, the LED 203 may go out as the electrodes 201 are disconnected for lack of the fluid sample. As a result, the quantity of collected sample may not be stable or as scheduled. From this perspective, the adjustable resistor Rl (205) further has another function, i.e. reducing the sensitivity of electrodes 201. The infinitely large resistor R between the electrodes 201 gradually becomes smaller after the electrodes are conducted by the fluid sample. The serially connected adjustable resistor Rl (205) increases the total resistance so that the electrodes 201 are not easily conducted with higher stability. In a detailed embodiment, the resistor Rl (205) after the resistance is over IMohm can effectively enhance the stability of electrodes 201.

Table 1 shows the LED 203 lights up and goes out when the collecting device 700 collects the fluid sample with variable resistances of the adjustable resistor Rl (205). Table 1 : (5 samples in each group)

When the collecting part 100 is full of the fluid sample, i.e. infinitely small resistance R (R refers to the sample resistance), the adjustable resistor Rl (205) is up to certain value which is too large to form a current activating the LED 203 emitting light. As a result, the collecting device 700 fails the indicating function. For this reason, the resistor Rl 205when serially connected to the resistor R (R refers to the sample resistance) had better not be infinitely large.

In a preferred embodiment, the adjustable resistor Rl (205) ranges from IMohm to 8Mohm

The collecting device can be applied to collecting samples of different resistances, i.e. different conduction resistances between electrodes. In a more preferred embodiment, the quantity of collected sample can be controlled and regulated by voltage and resistance. For example, when the collecting device collects the saliva sample, a voltage is preset according to the saliva resistance to regulate the quantity of collected body fluid by the adjustable resistor; while when the device collects the body fluid, another voltage is re-set according to the body fluid resistance to regulate the quantity of collected body fluid by the adjustable resistor.

Handle 300

In some other detailed embodiments as shown in Fig.7 and Fig.8, the collecting 100 can be connected to the handle 300 which is designed with a cavity 301 1 having an opening. The handle 300 can be adhered and connected to the collecting part 100 by the sticking plate 400. One end of the handle 300 can be fixed on the collecting part 100 by the sticking plate 400 in a plurality of manners such as the hasp or glue. And the end 102 of collecting part 100 can be fixed in the sticking plate 400. In a preferred embodiment, the electronic unit 200 is arranged in the cavity 301 1 of the handle 300. More specifically, the whole electronic unit 200 can be placed into the cavity 3011 as the processor 202 and the cavity 301 1 have the same opening. One end 201 1 of the electrodes 201 in the cavity contacts the end 102 of collecting part 100 through 400. In addition, the electronic unit 200 comprises an electrical signal element 203 to generate the identification signals. The signal element 203 such as LED can be integrated on the processor 202.

When one end 101 of or the whole collecting part 100 is placed into an organ of human or mammal, the fluid sample gradually contacts and fills in the collecting part 100. The fluid sample in the collecting part 100 if reaching the end 102 of collecting part can conduct two or a plurality of electrodes 201 at the end 102 of collecting part to form a current circuit, which activates the processor 202 for an electrical signal transmitted to the signal element 203 to generate the identification signals, such as LED creating light to indicate that the fluid sample collected in the collecting part 100 is enough.

In another optional embodiment, the collecting device further comprises a test element for analyte in the test sample. In a detailed embodiment, the test element is placed in the handle 300. The handle 300 is connected to the collecting part 100, so the fluid in the collecting part 100 can flow to the test element. The fluid in the collecting part 100 can also flow to the test element indirectly by other guiding materials such as filtering paper. In another detailed embodiment, the electronic unit 200 is also arranged in the cavity, and the electrodes 201 of electronic unit are connected to the collecting part 100. The electronic unit 200 activates the signal element 203 to generate the identification signals, indicating the collected sample is enough, if the collecting part 100 collects enough fluid samples. The operator stops collecting the sample. Then the fluid sample in the collecting part 100 passes through the sample-receiving area, marking area and test area in sequence. At last, the operator can read the test result from the test area at the test element.

The handle 300 can further comprise a channel or cavity, one end of which is connected to the cavity body 3011, and another end of which is connected to the handle end 303 or holding part 302. The light source at the handle front 301 can be transmitted to the handle end 303 or the holding part 302 through the channel, and directly found by the sampling operator who will stop collecting the sample. In an optional embodiment, one or a plurality of components among the handle 300, cavity body or holding part 302 (middle) can be made of transparent materials such as transparent plastic, glass and so on. Therefore, the lighting element 203 in the cavity can be observed.

In another preferred embodiment, the handle end 303 is arranged with a special reflective or refractive structure such as fan-shaped grooves 3031 or convex and concave spots 3032. In some cases, strong light is needed to transmit to the handle end 303 and received by the operator for space limit. For example, the operator has to take the holding part 302 of the collecting device 700 to collect the saliva sample, and at this time he/she only see the handle end 303 of the collecting device 700 when putting the collecting part 100 into the mouth to collect saliva.

The special structures 3031 , 3032 at the end 303 of the handle 300 can repeatedly reflect and/or refract the light transmitted to the handle end 303 so that the operator can receive more light. The main operation principle is as shown in Fig.12: a refers to the handle material, b to outside air, c to interface between the hand and the air, and d to the normal perpendicular to the interface c. The light Al is transmitted from the handle front 301 to the handle end 303, arriving at the point e on the interface c. The light Al is reflected and refracted on the interface c according to the reflection and refraction laws. If the handle material is denser than the air, the reflected light A2 is still in the handle a, while the refracted light A3 enters into the air b, wherein the incident angle a is equal to the reflected angle β and the refracted angle γ is larger than the incident angle a. The light A2 in the handle material a may be reflected and refracted again when getting to another points on the interface between the handle material a and the air; the light A3 entering into the air may be received by the operation in the eyes' direction, enter into other directions, or be reflected and refracted again when getting to other points on the interface between the handle material a and the air. More light is generated by reflection and refraction of the light A2 and A3. In this way, all light like Al transmitted from the handle front 301 to the handle end 303 would be reflected and refracted by the special structures 3031 , 3032 at the handle end. Consequently, the reflected and refracted light will create more light. As a result, more light enters into the air from the handle end 303 and more light is reflected at handle end 303 in the air. Finally, the light around the handle end 303 in the air is greatly increased, so more light is received by the eyes of operator accordingly. Therefore, the operator can see brighter light at the handle end 303.

In some preferred embodiments, the handle 300 is designed with a cavity to facilitate the light source to transmit from the handle front 301 to the handle end 303. In this way, the light at handle front 301 can directly be transmitted to the handle end 303 by the cavity to avoid the light loss caused by refraction in the handle material. More preferably, the handle front 301 and the middle 302 are made of opaque materials and only the handle end 303 is made of transparent materials so as to avoid the light loss during transmission.

An embodiment of this invention is described minutely in the structure and use directions as follows.

In a detailed embodiment of this invention as shown in Fig. l and Fig.7, the collecting device 700 comprises the collecting part 100 absorbing the fluid samples and the electronic unit 200. The electronic unit 200 comprises the electrodes 201 , the processor 202 and the LED 203; further more it comprises the power supply (battery) 204 as shown in Fig.9, wherein the collecting part 100 is connected to the electronic unit 200. More specifically, one end 102 of the collecting part is connected to one component of the electronic unit 200 (one end 2011 of the electrodes 201), another end 2012 of the electrodes is connected to the processor 202, and the LED 203 is also connected to the processor 202.

In operation, two electrodes 201 may be conducted by chance. For example, the fluid sample accidentally gathers at the two electrodes to form a current circuit, but it does not flow into other parts of the collecting part. Thus, the quantity of collected sample is different from the preset collected amount. For more stable test result, more electrodes 201 can be evenly distributed at one end 102 of the collecting part 100. In a preferable detailed embodiment, the electronic unit 200 is evenly equipped with 5 electrodes 201 (Jl , J2, J3 , J4, J5). In a more preferred embodiment, one J5 of the 5 electrodes is used as the power supply, another electrode J2 is applied as the grounding terminal, and the rest three electrodes Jl , J3 , J4 are serially connected to the adjustable resistor Rl (205), as shown in Fig. 4. The AND gate logic principle is applied to the input terminals A, B and C of three electrodes Jl, J3 and J5 connected to the adjustable resistor Rl (205) to activate the processor 202 generating output signal Y (A*B*C=Y, if a high level is input into the three input terminals A, B and C, a high level is output at the output terminal Y; if a high level is input into 0, 1 or 2 input terminals, no high level is output at the output terminal Y). The output terminal Y is connected to the signal element 203. If three electrodes J 1 , J3 and J4 are conducted, the output terminal is conducted to activate the signal element 203, generating the indication signals. The operation principle of each of the three electrodes Jl, J3 and J4 is as shown in Fig. 5. The formula (3) is as follows.

Vcc/(R+Rl)=Vt/Rl

Vcc refers to the power voltage provided by J5, Vt refers to the threshold voltage of processor 202, R is the electrode resistor and Rl is the adjustable resistor. If the formula (3) is workable (i.e. the conduction current), the electrodes J 1 , J3 and J4 are conducted to form a circuit conducting the output terminal Y according to the AND gate logic principle (A*B*C=Y), thus activating the signal element 203 to generate signals (LED lighting), which indicates the expected quantity of sample is collected.

The threshold voltage Vt of processor 202 relates to the product mode. Once the mode is selected, the threshold voltage is determined. Similarly, if the power voltage Vcc is reduced, the resistor R is decreased so that more fluid sample is collected accordingly; inversely if the power voltage Vcc is raised, the resistor R is increased so that less fluid sample is collected accordingly. The adjustable resistor Rl relates to R: when Rl is raised, the resistor R is decreased so that more fluid sample is collected accordingly; or when Rl is reduced, the resistor R is increased so that less fluid sample is collected accordingly.

More specifically, MOS tube principle is applied to the grounding electrode J2 as shown in Fig. 6. When the power voltage is 0 (the power supply is disconnected when the collecting device is not used), the input terminal of grounding electrode J2 is in a high impedance state, i.e. the processor 202 in an off state. In this way, it ensures the electronic unit 200 is disconnected when the collecting device is not used, which improves the accuracy of collecting device 700 with energy conservation (it avoids that the expected quantity of sample is not collected due to power drop). In a detailed embodiment, the resistance of adjustable resistor Rl (205) serially connected three electrodes is l-20Mohm. In a more detailed embodiment, the resistance is l-8Mohm.

In a more detailed embodiment as shown in Fig. 7 and Fig.8, the collecting device further comprises a handle 300 connected to one end 102 of the collecting part 100. The handle 300 consists of the font 301 connected to the collecting part 100, the middle suitable for hand holding 302 and the handle end 303. In a more preferred embodiment, the handle front 301 has a cavity 3011. More preferably, all elements of the electronic unit 200 are integrated in the handle cavity 301.

As shown in Fig.8, the electronic unit 200 is arranged in the cavity 301 1 at the front of handle 300, one 2011 of the electrodes 201 is placed into one end 102 of the collecting part 100, and another end 101 of the collecting part 100 contacts the sampling position and collects the sample. The collected sample reaching certain mount flows into the end 102 from another end 101 in the collecting part 100, and contacts the end 2011 of electrodes at the end 102 of collecting part. With more fluid collected, the sample is gradually increased at the end 2011 of 5 electrodes. Finally enough fluid conducts the electrodes 201 to generate a high level which conducts the signal element 203, i.e. LED lighting.

For the LED 203 arranged in the cavity 301 1 of handle front 301, the handle 300 containing the electronic unit is made of transparent materials such as transparent plastic, glass and so on. In the embodiment, the handle is made of transparent ABS. If the required quantity of sample is collected in the collecting part 100, the electrodes 201 are conducted so that the electronic unit 200 activates the LED 203 to emit light at the cavity 3011 of handle front which is transmitted to the whole handle 300 due to the transparent material of handle. The operator who sees the whole handle 300 lighting would stop collecting the sample. However, the operator taking the holding part 302 is hard to see the handle front 301 and the middle (holding part) 302 when putting the collecting part into the mouth of subjects, such as collecting saliva. In this case, only the light at the handle end 303 can remind the operator if the collected sample is enough. The light at the handle front 301 from the LED 203 after transmitted to the whole handle is greatly reduced in quantity and brightness at the handle end 303 which is farthest from the handle front 301. Therefore, the light at the handle end is too week to be clear or observed. In the embodiment, the grooves 3031 and convex-concave points 3032 at the handle end 303 help increase the light in quantity and brightness by reflection and refraction during transmission so that the operator can find the light more easily. The handle end 303 is designed with fan-shaped grooves 3031 and convex-concave points 3032 as shown in Fig. 11. The light reaching at the handle end 303 is reflected and refracted at the interface between the grooves 3031 and the air, and then the reflected light is reflected and refracted again at another interface between the grooves 3031 and the air. In this way, the light quantity is greatly increased by repeated reflection and refraction, so more refracted light in the air enters into the eyes of operator. The operator is easier to observe the light at the handle end 303 transmitted from the LED 203 in the cavity 3011 at the handle front 301. Fig. 14 shows a schematic diagram of light reflection and refraction. The light D from the LED 203 transmitted to the interface g between the fan-shaped grooves 3031 at handle end 303 and the air is reflected and refracted according to the reflection and refraction laws to release the reflected light E and refracted light F. The refracted light F may enter into the observation range of the operator' s eyes and may be observed by him/her. The reflected light E reaching the interface h between another groove 3031 and the air is reflected and refracted again to create another reflected light G and refracted light H. The reflected G that may arrive at other position of the handle end 303 is reflected and/or refracted again. The refracted H getting to the interface k between the air and the groove would be reflected and/or refracted another time.

In another embodiment, the handle 300 is connected to the collecting part 100 which is designed with a retainer 500. Fig.7 and Fig 10 show that the retainer 500 is arranged at the one end 102 of the collecting part and one end of the retainer is connected to the front 301 of the handle 300. More specifically, the retainer 500 and the handle 300 are formed one time. The electronic unit 200 is arranged in the front cavity 301 1 of handle 300 with the retainer 500 and one component of the electronic unit 200 (one end 2011 of the electrodes 201) contacts the end 102 of collecting part 100. In the embodiment, the end 2011 of electrodes is located in the end 102 of collecting part, wherein a sticking plate 400 made of waterproof materials is amounted between the electronic unit 200 and the collecting part 100 to prevent other electrical elements of electronic unit

200 from being soaked by the fluid sample, and the end 201 1 of electrodes 201 passing through the sticking plate 400 contacts the collecting part 100. One end 102 of the collecting part is arranged in the inside of the retainer 500 as the collecting part 100 is connected to the handle 300. The inner diameter of retainer 500 is the same as the diameter of collecting part 100. The retainer 500 is not limited in height (the higher, the better), but it had better not be higher than half of the collecting part. In a detailed embodiment, the height of retainer 500 is the same as that of electrodes 201 in the collecting part 100.

The retainer 500 is designed at the position where the collecting part 100 is connected to the electrodes 201 to reduce or eliminate the chance that the sample contacts the electrodes 201 at beginning, which delays the time the electrodes

201 contact the sample and ensures the collecting part 100 is filled with the sample. In addition, the retainer 500 can avoid the collecting part 100 with the retainer from moving at the sampling position; thus the electrodes 201 do not directly contact the sampling position or the sample to mistakenly conduct the electrodes.

The fluid sample over lmL is generally collected when the collecting part 100 is fully filled with the sample. The sample ranging 0.5 mL to 1 mL often can ensure smooth test. After the sample is taken for test, the rest (over 1 mL) can be used for the second test.

Table 2 show the quantity of collected fluid sample when the collecting device does not have a retainer and is designed with high and low retainers (32 samples are acquired) Table 2:

The table 2 shows the ratio of samples with the collected quantity less than 0.5 mL is clearly decreased when the collecting device is arranged with the retainer 500 or the retainer is heightened. Therefore, the sample quantity collected by the collecting device 700 can ensure smooth test.

Claims

1. A device for collecting fluid samples, comprising a fluid-collecting part and an electronic unit which at least comprises two electrodes and processors, wherein the electrodes contact the collecting part and the electronic unit can regulate the collected volume.

2. The device according to claim 1 , wherein the electronic unit regulates the collected sample by variable voltages.

3. The device according to claim 2, wherein the voltage varies inversely with the quantity of collected samples.

4. The device according to claim 3, wherein the variable voltage is caused by a variable power supply.

5. The device according to any of claim 1-4, wherein the electronic unit regulates the quantity of collected samples by adjustable resistance

6. The device according to claim 5, wherein the resistance varies directly with the volume of collected sample.

7. The device according to claim 6, wherein the electronic unit consists of 5 electrodes.

8. The device according to claim 7, wherein one of the electrodes is used as the power end.

9. The device according to claim 8, wherein one of the electrodes is used as the grounding terminal.

10. The device according to claim 9, wherein the rest electrodes are connected to adjustable resistors.

11. The device according to claim 10, wherein the adjustable resistors can reduce the sensitivity of the connected electrodes.

12. The device according to claim 11 , wherein the adjustable resistors range is l-8Mohm.

13. The device according to claim 12, wherein the electrode connected to the grounding terminal is regulated by a MOS tube.

14. The device according to claim 1 or claim 13, wherein the electronic unit further comprises signal elements.

15. The device according to claim 1 or claim 13, wherein the signal element is LED.

16. The device according to claim 1 or claim 15, wherein the fluid-collecting device further comprises a rod or handle connected to the collecting part.

17. The device according to claim 16, wherein the rod or handle is made of transparent materials.

18. The device according to claim 17, wherein the rod or handle is designed with a reflective structure.

19. The device according to claim 18, wherein the reflective structure is fan- shaped with grooves at the handle end.

20. The device according to claim 18 or claim 19, wherein the reflective structure at the handle end is arranged with convex or concave spots.

21. The device according to claim 20, wherein the electronic unit is arranged in the cavity of the rod or handle.

22. The device according to claim 1 or 21, wherein the collecting part is equipped with a retainer

23. The device according to claim 22, wherein the retainer is adjacent to or connected to the handle.

24. The device according to claim 23, wherein the retainer is as high as the electrodes in the collecting part.