WO2012003797A1 - Liquid sample collection device - Google Patents

Abstract

A sample collection device comprising: a sample receptacle (400) to contain samples, and two unidirectional valves (200, 300) connecting to the receptacle (400). The present invention also provides a method of sample collection via the sample collection device. Provided with two unidirectional valves, the sample collection device enables improved sealing and vacuum pumping effects, and is able to collect an adequate quantity of samples, thus increasing sample collection efficiency while at the same time effectively blocking sample backflow to prevent a user from being contaminated by the samples.

Description

 Device for collecting liquid samples

Technical field

 The present invention relates to a sample collection device, and more particularly to a collection device consisting of a sample receptacle and a one-way valve. The invention also relates to a method of collecting a sample using such a sample collection device. Background technique

 In the treatment and diagnosis of diseases, the detection and analysis of various types of disease samples is indispensable. To analyze accurate data, it is extremely important to collect samples of samples that need to be tested. Therefore, many methods and devices for collecting samples have been invented and used. Currently, devices for collecting various fluid samples are widely used in medical analytical testing and medical diagnostic systems. U.S. Patent No. 2009/0024058 A1 discloses a liquid sample collection device which is mainly composed of a sample collection box, a collection baffle connected to the collection box, and a one-way valve communicating with the two. The air in the device is drained, but the outside air is prevented from flowing back into the device. The sample collection device discharges the air in the collection vessel through the one-way valve by the pressure of the fluid collected in the collection box, thereby collecting the sample into the collection vessel to complete the collection process. This sample collection device is simple and convenient to operate, and can collect large sample sizes, making it possible to collect samples in batches clinically. However, this collection device still has some problems: the pressure of the fluid itself causes the sample to flow into the collection vessel, and the amount of liquid collected is not large enough; in addition, some samples may not be returned to the collection box due to insufficient pressure, resulting in sample contamination. Or polluting the sampler.

Of course, there are other fluid sample collection devices, such as another US Patent No. 006 022 326 A, which discloses an apparatus and method for collecting liquid samples by means of a vacuum pump using a small vacuum pump. However, such devices cannot be widely used and are inefficient. SUMMARY OF THE INVENTION To overcome the above problems, the present invention provides a sample collection device. The collection device includes a sample receiver for holding a sample and two one-way flow check valves connected to the sample receiver. When the device is in operation, the two check valves are not open at the same time, that is, when one check valve is opened, the other check valve is closed. For example, in an alternative, when one check valve opens and exhausts gas or liquid from the inside of the receptacle, the other check valve closes; and when the other check valve opens, the exhaust or liquid The check valve is closed. In a specific manner, when one check valve discharges air or liquid to the outside, when the negative pressure is generated in the receiver, the other check valve is closed; when the other check valve is opened, due to the pressure balance Acting, the external gas, liquid sample, or another gas in communication with the other one-way valve enters the sample receiver through the open one-way valve, and the air-discharged check valve is now closed. This allows the required sample to be collected in the receiver, which can be a gas sample or a liquid sample.

In some preferred forms, the sample receptacle can include an opening, and the two one-way valves are coupled to the opening of the sample receiver and are coupled to opposite sides of the open end, respectively. Alternatively, the receiver may include two openings, two of which are connected to the two openings, respectively.

 The sample receiver described above is for receiving and containing samples collected by the device, and the receiver can be made of any material that meets medical standards. In some more preferred embodiments, the receiver can be made of a resilient material. Such as rubber, plastic, PVC and silica gel, etc.; or other elastic materials, and can achieve the following functions: that is, when there is force acting on the receiver, such as squeezing the receiver, the receiver will automatically compress, the receiver The inner space is reduced, forcing the air or sample in the receiver to exit the outside through a one-way valve, at which point the other check valve is closed, thus causing the receiver to form a differential pressure with the outside atmosphere; thereby creating a negative pressure in the receiver. State, the resulting negative pressure forces a sample of gas or liquid in communication with another one-way valve into the receiver. More preferably, if the receiver is re-squeezed, the collected liquid or other sample is discharged to the outside of the receptacle through the open check valve, and the sample is collected again, so that the liquid or gas sample can be continuously collected.

 In other ways, the receiver can also be made of a transparent material. "Transparent" means a material that is permeable to light so that under normal room light, a person's naked eye can see the object behind the transparent material, and the person using the device can see the sample size under the transparent window. Or test the results.

 In some embodiments, the sample receiver in the device can be replaced and connected to the one-way valve in a detachable manner. When the sampling is complete, the sample is collected into the receiver and the receiver can be removed and replaced with another receiver. This allows batch sampling. The receiver can be used once or repeatedly.

 In other embodiments, after the sample collection is completed, the receiver may be removed, the sample may be poured onto the detecting component, or sampled into the receiver and sampled and added to the detecting component for detection; or at the receiver The test element is directly placed in the test element, such as a test strip for testing a component in the saliva, and the test sample is directly contacted with the test component while the sample enters the receiver.

In another more preferred manner, the other end of the one-way valve connected to the sample receiver is connectable The dripper, when the sample is collected in the receptacle, can be applied to the receiver by applying pressure, such as squeezing the sample receiver with elasticity, so that the pressure inside the receptacle is increased, so that the check valve connected to the dripper is When opened, the sample in the receiver is discharged to the test element through the check valve and the dripper for detection.

 In some preferred ways, to ensure that the sample obtained is convenient for transport or storage and to keep the sample free of contamination, a lid for sealing can also be mounted on the sample receiver. When the device has been sampled, the receiver is removed, the lid is closed, and the sample is sealed in the receptacle and will not leak, whether flipped or shaken. Alternatively, a sampling pipette associated with the receiver opening may be designed to seal the receiver for storage of the sample. In a more preferred solution, a dripper device is designed inside the cover sealed with the receiver. When the collecting device is sampled, the receiver holding the sample is removed, and the cap is closed. The inner dripper is in close contact with the receiver to seal the sample. When it is necessary to detect the sample in the receiver, the lid is unscrewed, and the dripper and the lid inside the lid are detached, but are still in close contact with the sample receiver, and the sample can be discharged to the detecting member through the dripper.

 The "check valve" of the present invention is identical in construction and function to valves known in the art, i.e., ensuring that the fluid passes through the valve from one direction, while the other direction, including the opposite direction, does not circulate, thereby achieving the purpose of controlling the flow direction. For example, in the present invention, a one-way valve ensures that air or sample is discharged outwardly along the receiver, while air or other fluid from the outside cannot be recirculated into the receiver through the one-way valve. Another one-way valve allows fluid such as sample or air to flow into the sample receiver along the one-way valve, but any fluid within the receiver cannot flow back through the one-way valve.

 In the present invention, the way in which the check valve and the sample receiver are connected is various and can be directly or indirectly connected. For example, the check valve can be connected directly to the sample receiver, or it can be connected via a pipe, connected via a cover placed on the sample receiver, or otherwise connected. Each of the two components can be joined by injection molding, riveting, welding or screwing, or a sealed component can be added at the joint to ensure the tightness of the sample collection device, such as rubber gaskets. Regardless of the manner in which they are connected, the two one-way valves are in communication with the sample collector. In one embodiment, the sample receiver has an opening in the upper portion, a cover is mounted on the opening, two ports are opened in the cover, and one of the two ports is connected to a one-way valve, and the two check valves and the receiver cover are One injection is connected together.

In some embodiments, the sample collection device further includes a sample collection component. The collecting member is in communication with a one-way valve. Similarly, the two parts are connected and connected in a variety of ways, including but not limited to direct or indirect connection using injection molding, riveting, welding, or spiraling, such as: pipe connection, joint Connect and so on. The sample collection part is made of materials that meet medical standards. In some embodiments, The collecting member is made of a soft material that can be bent and freely rotated, and the collecting member made of the material needs to satisfy the function that the collecting member can adjust the angle and direction of the collecting member as needed according to the needs of the operator. For example: Flexible silicone, plastic, plastic and PVC materials that are harmless to the human body.

 In one embodiment, two one-way valves are respectively coupled at both ends of the sample receiver, with the other end of the first one-way valve being coupled to the sample collection member. When forcefully acts on the elastic sample receiver, the receiver compression causes the internal space to become smaller and the pressure to increase. At this time, the second one-way valve communicating with the receiver is opened due to the pressure increase. The air in the receiver is discharged outward through the one-way valve to maintain the pressure balance in the receiver; when the external force is removed, the elastic receiver rebounds due to the characteristics of the material itself, then the receptacle returns to the original state, and the inner space becomes larger. Forming a negative pressure state that forces the second one-way valve that is open to the atmosphere to close, while opening the first one-way valve connected between the sample receiver and the sample collection member, also due to the negative pressure, by collecting A liquid or gas sample of the component or within the sample collection component flows into the sample receiver along a first one-way valve in communication therewith to complete collection of the sample. In another embodiment, the other end of the second one-way valve connected to the sample receiver is connected with a dripper, and after the sample is collected into the receiver, the elastic receiver is squeezed again, because the space compression in the device becomes smaller. The internal pressure is increased, the second check valve connected to the dripper is opened, and the sample in the receiver is discharged along the check valve and the dripper.

 In another embodiment, a sample tube is disposed in the sample receiver, the tube is sealed at one end, one end is open, and the open end is in communication with both the sample receiver and the check valve. In a specific manner, the test tube is coupled to the check valve and the sample receiver via a cover located on the receiver. When the sample flows into the sample collection device through a one-way valve, it flows directly into the collection tube located in the receptacle. This collection tube can be replaced and used to collect samples in batches. The test tube material can meet medical requirements, and can be a hard material such as a glass product; or an elastic material such as rubber, plastic, silicone or the like. The tube can be used once or repeatedly.

In another embodiment, an elastic squeezer is provided that is compressible air between the sample receptacle and the second check valve. The elastomeric extruder material can be the same or similar to the elastomeric receiver material and can function the same. Such as rubber, plastic, PVC and silica gel, etc.; or other elastic materials, and can achieve the following functions: that is, when there is force acting on the extruder, such as pressing the extruder, the extruder will automatically press Shrinking, reducing the space inside the extruder, forcing the air inside to discharge, and when the external force disappears, the extruder will automatically return to its original state, thereby forming a negative pressure state inside. When the extruder is squeezed, the extruder is compressed by the elastic, the internal space is reduced, the pressure is increased, and the increased pressure forces the check valve 2 connected thereto to open, and the air circulates outward in one direction; After the force disappears, such as loosening the extruder, the elastic extrusion The device returns to its original state due to the rebound of the material properties. At this time, due to the increase in the space of the extruder, the gas generates less negative pressure, which forces the second check valve of the exhaust gas to close and forces the connection to the sample collection member and A first one-way valve between the sample receivers is opened such that the sample flows along the first one-way valve into a test tube within the receiver or receiver. In some other embodiments, the elastomeric squeezer can be replaced with a medical dripper after sampling and the sample is discharged through the dripper. In this embodiment, the sample receiver can be made of an inelastic material, such as a licking mouth.

 As another implementable manner, the connection order of the device may be changed, for example: two check valves are respectively connected to two sides of the elastic extruder, that is, one check valve is only connected to the elastic squeezer; One end of the valve is connected to the elastic extruder, and the other end is connected to the sample receiver and the sample collection part, such as a three-way joint. The flow direction of the two check valves is the same, and the specific implementation method is the same as that of the previous embodiment. In this embodiment, after the sampling is completed, the sample collection unit and the sample receiver can be replaced, and the two check valves and the elastic extruder can be reused.

 In the above embodiment, the sample collecting member may specifically be a collecting long tube made of a flexible soft material, and a wire may be added to a collecting tube in order to increase its elasticity and strength. Alternatively, to increase its adjustable angle, a curved corrugation can be designed in the soft plastic collection tube section, which is identical or similar to the straw design currently available on the market for soft packaged beverages. Of course, in order to increase the absorption effect at the time of sample collection, an elastic hollow tip can be provided at the top of the sample collection tube.

 In the above embodiment, the one-way valve is not limited to two, and three, four, or more one-way valves may be directly or indirectly connected in the sample collection device. For example, a check valve is connected between the first check valve and the sample receiver, and the opening direction is the same as the first check valve. Alternatively, in another embodiment, the receiver may have three openings, each of which is connected to a one-way valve, one check valve to allow liquid or gas samples to enter the sample receiver, and the other two check valves to make the receiver The gas or liquid is discharged; or vice versa, that is, two check valves allow the sample to enter the receiver, and a one-way valve discharges the gas or liquid in the device; this embodiment can increase the collection efficiency of the sample collection device.

 The present invention also provides a method for collecting a sample, comprising: providing a sample collection device, the device comprising a sample receiver and first and second one-way valves, wherein the three are connected;

Opening the second one-way valve to allow gas or liquid in the receiver to be discharged through the one-way valve while the first one-way valve is closed;

The first one-way valve is opened, allowing a gas or liquid sample to pass through the one-way valve into the receiver while the second one-way valve is closed. Preferably, the sample receiver is compressed to form a pressure that causes the second one-way valve to open, causing the first one-way valve to close.

 Alternatively, a negative pressure is created in the sample receiver; the negative pressure causes the second one-way valve to close and the first one-way valve to open.

 More preferably, the sample receiver has elasticity; the elastic receiver is squeezed to compress to form a pressure that causes the second one-way valve to open; the elastic receiver is released, and a negative pressure is formed in the receiver, the negative pressure The two check valves are closed and the first check valve is opened.

 In another more preferred method, the apparatus further includes an elastic extruder coupled to the second one-way valve; the elastic extruder is squeezed to compress to form a pressure, and the pressure causes the second one-way valve to open to make the first The check valve is closed; the elastic squeezer is released, a negative pressure is formed in the extruder, the negative pressure closes the second check valve, and the first check valve is opened. Beneficial effect

 The invention increases the sealing of the whole collection system by providing two one-way valves, and the vacuum degree is high when the vacuum is squeezed, so that the sample flows along the one-way valve is large, and the flow speed is fast, and a sufficient liquid sample amount can be received. , improved sample collection efficiency. Moreover, the same sample can be collected repeatedly to achieve the required sample size, thereby enabling sufficient testing or testing. In addition, such a collection device prevents the sample from flowing back due to the good sealing effect, thereby eliminating the possibility of sample contamination of the sampler. The invention has simple operation and convenient production, and improves the collection efficiency in the actual operation process. DRAWINGS

Figure 1 is a cross-sectional view of a first embodiment

Figure 2 is a cross-sectional view of a second embodiment

Figure 3 is a cross-sectional view of a third embodiment

Figure 4 is a cross-sectional view of a fourth embodiment

Figure 5 is a cross-sectional view showing a structure of a collecting pipe

Figure 6 is a cross-sectional view of the collecting tube shown in Figure 5.

Figure 7 is a cross-sectional view of another structure of the collecting tube

Description of the figures

Sample collection component 100; one end 101 of the collection component; the other end 102 of the collection component; sample receiving One end 401 of the receiver; the other end 402 of the receiver; the first check valve 200; the second check valve 300; the dripper 500; the collection tube 600; the elastic extruder 700; one end of the elastic extruder 701, the other end 702 of the elastic extruder; the collecting tubes 110, 120; the wire 111; the structure of the liquid sample collecting device or the technical terms used are further explained below. sample

 The samples referred to in the present invention refer to those substances which can be used to detect, assay or diagnose the presence or absence of an analyte of interest. The sample may be a fluid sample, for example, a liquid sample, which may include blood, plasma, serum, urine, saliva, and various exudates, and may also include a liquid solution formed by pre-treating the solid sample and the semi-solid sample. The sample can also be a gas sample. The collected samples can be used, but are not limited to, immunoassays, chemical tests, enzyme assays, etc. to detect the presence of analytes. Collecting parts

 In some specific embodiments, the fluid sample collection device includes a fluid collection component. In a preferred embodiment, the fluid collection component consists essentially of a water absorbing material that absorbs and stores the liquid sample by chemisorption. The material constituting the fluid collecting member may be selected from the group consisting of polyvinyl alcohol (PVA), foamed plastic, resin, sodium polyacrylate crosslinked product, acrylic acid monovinyl acid copolymer, acrylonitrile polymerized saponified product, vinyl alcohol or sponge, filter paper, glass One or a combination of fibers, nonwovens or acetate. A more preferred solution is that the material constituting the fluid collecting member is foamed polyvinyl alcohol. The shape of the collecting member may be any suitable shape such as a cylindrical shape, a rectangular parallelepiped shape, a tapered shape, or the like. In a more specific manner, the collection member 100 includes two ends 101 and 102; one of the ends 101 is for contact with a fluid sample and the fluid sample is absorbed into the collection member. The other end 102 is connected to the one-way valve 200. In other embodiments, the collection components are specifically collection tubes 110, 120. detailed description

 In the following detailed description, the annexed drawings It is not to be understood that the invention may be practiced otherwise without departing from the scope of the invention.

1, the collection device shown includes a sample collection component 100, a sample receiver 400, a first one-way valve 200, and a second one-way valve 300. The one-way valve 200 is connected to one end 102 of the collecting member and one end of the receiver 401, the one-way valve 300 is connected to the other end 402 of the receiver; the two one-way valves 200, 300 and the sample receiver 400 are connected by a cover on the receiver; the connection between the components of the device is not limited, This embodiment shows a spiral connection. The first check valve 200, the second check valve 300, the collecting member 100 and the receiver 400 are in communication after being connected. The receiver 400 has elasticity and can be made of rubber, plastic, PVC or the like, and can also be made of a transparent material; in this embodiment, it can be specifically a transparent elastic plastic bottle. When an external force is applied, that is, when the receiver 400 is squeezed, the receiver shrinks the internal space, the air pressure inside the device increases, the pressure forces the second check valve 300 to open, and the air inside the device follows the opened second check valve 300. After the external force disappears, that is, after the receiver 400 is released, the receiver 400 returns to the original state due to the elastic characteristic, and the internal space increases to form a negative pressure, and the second check valve 300 is closed due to the negative pressure. The first one-way valve 200 is opened, and the sample in the collecting member 100 flows into the receiver 400 along the first one-way valve 200. The size of the sample receiver can be set according to the needs of sample collection, such as one-time sampling, or large sampling, and the capacity of the receiver can be different. The sample receiver can be any size between 3 ml and 10 ml.

 2 is an optimized manner of the first embodiment in which a collection tube 600 is connected to the elastic receiver 400, and the collection tube 600 is in communication with the first one-way valve 200, the second one-way valve 300, and the receiver 400. . In the present embodiment, when the external force is applied to the elastic receptor 400, the receiver is contracted, and the pressure is increased to cause the check valve 300 to open, and the air in the collection tube 600 and the receiver 400 is discharged. After the external force is removed, the receiver 400 returns to its original state, causing a negative pressure to be generated inside, forcing the check valve 200 to open, and the sample flows into the collection tube 600 along the first check valve 200. The collection tube 600 can be replaced, which is more conducive to repeated collection of samples. The shape of the elastic receiver 400 is not particularly limited as long as it satisfies the function of holding a sample, particularly a sample, such as a cylindrical shape, an elliptical shape or a rectangular shape, etc., as in the case of a normal bottle body.

 Fig. 3 is another embodiment in which an elastic extruder 700 is provided as compared with the first or second embodiment. The extruder 700 is coupled between the receptacle end 402 and the second check valve 300. When the elastic extruder 700 is squeezed, the space inside the extruder is reduced, the pressure is increased, the check valve 300 is forced to open, and the air is discharged; after the extruder is released, the internal space is increased to form a negative pressure due to the negative pressure. Acting, the one-way valve 200 is opened and the sample in the collection member 100 flows into the receiver 400 along the one-way valve 200.

Another embodiment may make it easier to replace the sampling components of the collection device, as shown in FIG. 4, the one-way valve 200, which may be located at each end of the elastomeric extruder 700, respectively. Thus, the check valve 300 and the end of the extruder Connected to 702, the one-way valve 200 is located between the other end 701 of the extruder and the sample receiver 400. Similarly, after the extruder is squeezed, the space inside the extruder is reduced, the pressure is increased, the check valve 300 is forced to open, and the air is discharged; after the extruder is released, the internal space is increased to form a negative pressure due to the negative pressure. Function, the one-way valve 200 is opened, and the liquid sample in the collecting member 100 flows into the receiver 400 along the collecting member. In this embodiment, after the sample collection is completed, the collection member and the sample acceptor can be replaced at the same time, and the next sample collection is performed. The device can be reused.

 In the first and second embodiments, the other end of the one-way valve 300 can be connected to the dripper 500, as shown in FIG. 1, after the sample collection is completed, the receiver 400 can be enlarged by squeezing the elastic sample receiver 400. The internal pressure forces the one-way valve 300 to open, and the sample in the receiver flows out through the one-way valve 300 and the dripper 500, and is added to the detecting device or the detecting element.

 In the above-described embodiments, the collecting member may be specific to the collecting tubes 110, 120 as shown in Figs. 5, 6, and 7. The collection tube can be made of a flexible material such as rubber, plastic, plastic, transparent PVC, and the like. To facilitate the operator's sampling, some improvements can be made on the hose: As shown in Figure 5, a thin wire 111 is added to the hose to increase the elasticity and strength of the collection tube; or, as shown in Figure 7, in the plastic hose section. Corrugated design can be added.

Claims

Claim A sample collection device comprising: a sample receiver for containing a sample, the collection device further comprising first and second one-way valves coupled to the sample receiver.  2. The apparatus according to claim 1, wherein the sample receiver is incapable of simultaneously circulating liquid or gas through the first and second one-way valves; or, the first one-way valve and the second one-way valve are not Close at the same time or open at the same time.  3. Apparatus according to claim 2 wherein the second one-way valve is closed when the first one-way valve is open.  4. Apparatus according to claim 3 wherein the first one-way valve causes a liquid or gas sample to enter the receiver; the second one-way valve discharges the gas or liquid sample in the receiver outward.  5. Apparatus according to claim 4 wherein the sample collection device further comprises a sample collection member, the first one-way valve being coupled between the sample collection member and the sample receiver.  6. Apparatus according to claim 1 or claim 5 wherein the sample receiver is a compressible resilient receiver.  7. Apparatus according to claim 6 wherein the sample receiver has a test tube therein; the test tube is in communication with the sample receiver, the first and second check valves.  8. Apparatus according to claim 3 including an elastomeric squeezer coupled between the sample receiver and the second check valve.  9. Apparatus according to claim 8 wherein the first and second one-way valves are respectively located at opposite ends of the elastomeric extruder.  10. Apparatus according to claim 8 or claim 9 wherein the elastomeric extruder is a plastic or rubber.  11. Apparatus according to claim 5 wherein the sample collection member is a flexible material that is bendable. 12. Apparatus according to claim 11 wherein a wire is added to the sample collection member.  13. Apparatus according to claim 11 wherein the sample collection component is a plastic collection tube and the intermediate portion is of a corrugated design.  14. Apparatus according to any one of claims 1 to 5, wherein the second one-way valve is connected to a dripper. The device according to claim 6, wherein when an external force presses the elastic receiver, The claim forms a pressure in the elastic receiver that opens the second one-way valve to close the first one-way valve; when the external force is removed, a negative pressure is formed in the elastic receiver, the negative pressure making the second The check valve is closed and the first check valve is opened.  16. A method of collecting a liquid sample, comprising: providing a sample collection device, the device comprising a sample receiver and a first, second one-way valve, the three being in communication;  Opening the second one-way valve to allow gas or liquid in the receiver to be discharged through the one-way valve while the first one-way valve is closed;  The first check valve is opened to allow a gas or liquid sample to pass through the check valve into the receiver while the second check valve is closed.  17. The method of claim 16 wherein the sample receiver is compressed to form a pressure that causes the second one-way valve to open to close the first one-way valve.  18. The method of claim 16 wherein a negative pressure is created within the sample receiver; the negative pressure causes the second one-way valve to close and the first one-way valve to open.  19. The method according to claim 16, wherein the sample receiver has elasticity; squeezing the elastic receiver to compress it to form a pressure that causes the second one-way valve to open; releasing the elastic receiver, receiving A negative pressure is created within the device that closes the second one-way valve and opens the first one-way valve.  20. The method of any of claims 16-19, further comprising an elastic extruder coupled to the second one-way valve; Squeeze the elastic squeezer to compress it to form a pressure, the pressure causes the second check valve to open, and the first check valve to close; release the elastic squeezer, a negative pressure is formed in the squeezer, and the negative pressure makes the second The check valve is closed and the first check valve is opened.