JP2016514843A - Apparatus for collecting fluid sample, receptacle receiving the apparatus, assembly for collecting fluid sample, and method for collecting fluid sample - Google Patents

Abstract

Fluid sample collection device, fluid sample collection device receptacle, fluid sample collection assembly, and method of collecting a fluid sample. The apparatus includes a carrier, an absorbent material disposed on the carrier, and a compression mechanism disposed on the carrier and compressing the absorbent material while applying a force. The compression mechanism has a non-absorbing tip of the carrier, and this tip is movable so as to compress the absorbent material while a force is applied. [Selection] Figure 3

Description

  The present invention relates generally to an apparatus for collecting a fluid sample, a receptacle for receiving the apparatus, an assembly for collecting a fluid sample, and a method for collecting a fluid sample. In one embodiment, the present invention collects a fluid sample, extracts filtered or unfiltered fluid onto a dispense channel, and directs the fluid to a predetermined location via a microfluidic channel structure. About that.

  Collection and delivery of fluid samples in a clean and contamination-free manner is desirable for many applications, such as urine sample collection, water sample collection, or blood sample collection.

  In such applications, after collection, it is desired to dispense the collected fluid sample centrally to the inlet port of the microfluidic channel.

  Some existing techniques include the use of pipettes and disposable tips, disposable syringes, or microfluidic systems with pumps and valves.

  Existing methods for collecting fluid (eg, water, urine, blood, etc.) in a sensing system mainly collect the fluid in a cup and then dip a dipstick in the cup or absorb the liquid Dispensing the fluid through a passive fluid channel to a predetermined sensing area and performing a qualitative measurement. In other cases, for example, in pregnancy test kits that include chemical test strips, urine is brought into direct contact with the test strips during urination and carried to the detection site by passive microfluidics incorporated into the test kit.

  Existing methods can work well with measurement systems that perform qualitative measurements on various hormones or other analytes in a solution of a liquid sample. However, in qualitative measurement systems where a liquid sample needs to be inserted at a specific location within the measurement system, the collected sample is transferred from the collection device, eg, a collection cup, to the measurement system using a pipette. . This procedure can usually only be performed by skilled professionals and is very likely to be zero when used by untrained users at home.

  Patent Document 1 describes a polymer medium that holds a reagent species used in a portable device that detects the presence of an analyte of interest in a sample relatively quickly. The sample is collected using an exposed swab located at the end of the sample rod and the sample rod is first inserted into the chamber with the swab where the swab and the seal located on the swab are pierced, Release the reagent solution stored in the reservoir of the sample bar.

  Patent Document 2 describes a specimen sample collection device and a test system. Samples are collected using an exposed absorbent pad forming the free end of the handle, and the handle is first inserted into the compression tube with the pad, where the pad is compressed and formed into the compression tube Sample fluid can be collected through the outlet.

US Pat. No. 7,060,223 US Patent No. 8,025,851

  Embodiments of the present invention will be better understood and readily apparent to those skilled in the art from the following description, by way of example only, in conjunction with the drawings.

1 is a schematic top view of a fluid sample collection assembly according to an example embodiment. FIG. FIG. 2 is a schematic perspective view of a portion of the fluid sample collection assembly of FIG. 1 is a schematic perspective view of an apparatus for collecting a fluid sample according to an example embodiment. FIG. FIG. 4 is a schematic top view illustrating insertion of the apparatus of FIG. 3 into a sensor receptacle, according to an example embodiment. FIG. 5 is a schematic front view of the apparatus of FIG. 3 inserted into the receptacle of FIG. 4 according to an example embodiment. FIG. 6 is a schematic cross-sectional view showing the direction of fluid flow during use of a fluid sample collection assembly according to an example embodiment. 1 is a schematic top view of an apparatus for collecting a fluid sample according to an example embodiment. FIG. 8 is a schematic top view, partially in section, showing movement of the tip of the apparatus of FIG. 7 upon insertion into a receptacle, according to an example embodiment. FIG. 8 is a schematic top view, partially in cross section, showing the lock when the tip of the apparatus of FIG. 7 is fully inserted into the receptacle, according to an example embodiment.

  Embodiments of the present invention collect fluid samples by absorbing with a suitable absorbent material, such as an absorbent sponge, by compressing the volume of the absorbent toward a predetermined port of the microfluidic channel. It relates to extracting filtered or unfiltered fluid and to compressing the absorbent sponge due to its elasticity or with the help of an external spring.

  The absorbent material itself can also function as a filtration mechanism that can filter a fluid sample, eg, filter material that is significantly larger than the organisms present in the fluid sample.

  The amount of fluid sample extracted from the absorbent material is preferably controllable by the amount of compression received by the absorbent material and the volume change received by the absorbent material accordingly. This amount of fluid sample to be dispensed can be important for microfluidic channels that transfer, for example, a fluid sample extruded by a sponge to a predetermined sensing region by active or passive microfluidic action.

  In order to favorably prevent back flow of fluid through the insertion channel by maintaining a gap between the absorbent and the outlet port, the diameter of the collection stick should be smaller than and equal to the diameter of the channel of the receptacle. Can be increased over the length of the collection stick. This feature can also serve to receive air trapped / residual in the sponge and can prevent the formation of bubbles in the microfluidic channel.

  FIG. 1 shows a schematic top view of a fluid sample collection assembly 100 according to an example embodiment. The example embodiment comprises a sample collection and delivery device, here in the form of a collection stick 102, which can be used here with a sensing device in the form of a card sensor 104. In an example embodiment, the sample collection stick 102 has an area (which is hidden in FIG. 1, compare FIG. 3 below) that incorporates a substance capable of absorbing fluid, such as a sponge or paper. The overall size of the collection stick 102 is preferably similar to the size of a standard pen and can be directly absorbed by dropping fluid into the absorption area or by immersing the absorption area of the collection stick in a container containing sample fluid. By wetting the material, it can be used to collect the sample.

  After fluid collection, the entire collection stick 102 is then inserted into a receptacle 106 that is designed to squeeze the absorbent, withdrawing the fluid trapped within the absorbent, and removing the removed fluid into the receptacle 106. To the exit port 108 of According to an example embodiment, the receptacle 106 is attached to the card sensor 104 and the outlet port 108 of the receptacle 106 is aligned with the microfluidic inlet port 110 of the card sensor 104. After fluid is drawn from the absorbent sponge and enters the microfluidic channel inlet port 110 in the card sensor 104, the fluid moves to various sensing areas (eg, 112, 114 on the card sensor 104).

  The volume of fluid dispensed into the microfluidic channel (eg, 116) depends in particular on the absorbency of the absorbent material, the absorbent surface to volume ratio, and also the compression experienced by the absorbent material. Preferably, the desired dispense capacity can be achieved by controlling one or more of these parameters of the absorbent material. For example, when an absorbent sponge is used as the absorbent material, the parameters that determine the dispense volume include the void volume of the sponge, the absorption capacity, and the retention capacity.

  The absorbent material may be trapped in air, for example, when the fluid does not completely penetrate the absorbent sponge. In such a case, it is possible that some air bubbles may enter the microfluidic channel after squeezing the absorbent sponge. In order to better address this potential problem, in one embodiment, the collection stick 102 has a predetermined tapered section. This is described in more detail below. The diameter of the collection stick 102 can be smaller than the channel 118 (see FIG. 2) of the receptacle 106 and can increase over the length of the collection stick 102 to be equal to the diameter of the channel 118. Thus, when the absorbent material is compressed and the stick 102 is snapped to the receptacle 106, the collection stick 102 in the region toward the closed end of the receptacle 106, i.e. where the diameter of the stick 102 is smaller than the diameter of the channel 118. And air can escape into the space between the wall of the channel 118.

  In an embodiment, it is preferred that the possibility that the user spills the fluid may be reduced, and this embodiment collects the fluid sample and inserts the collected fluid into the microfluidic channel of the measurement system. It may also be possible to enable

  Turning now to FIG. 3, the stick 102 has a non-absorbable tip, here in the form of a rigid tip 300. As a result, the absorbed sample fluid is spilled due to unintentional compression of the absorbent 302, for example, due to contact or contact with the wall of the receptacle due to misalignment with the channel 118 (FIG. 2). Advantageously it can be reduced or eliminated.

  Advantageously, the tip 300 has substantially the same cross-sectional dimensions as the absorbent material 302. In the example embodiment, the tip 300 and the absorbent 302 are adjacent cylinders or disks. Thus, the force applied to the rigid tip 300 as a result of abutting or contacting the wall of the receptacle before or during insertion is preferably distributed and is caused by the wall directly abutting or contacting a portion of the absorbent material. Compared to the local pressure, the pressure exerted on the absorbent 302 is reduced. Such higher local pressures can result in local compression and undesirable exudation of absorbed sample fluid.

  In addition to collecting the fluid sample, the absorbent 302 can also preferably be used to filter the fluid sample. In an example embodiment, the absorbent material 302 can be designed to have a certain defined pore size, and particles larger than this pore size can be removed. In this way, it is preferred that contaminants in the form of macroscopic particles, such as dust or sediment, can be removed from the fluid sample during sample collection, and therefore such macroscopic particles are detected in the microfluidic channel. Preferably, it is not delivered into the structure.

  Referring to FIG. 4, an example embodiment provides a centralized method for collecting a fluid sample and delivering it through a microfluidic channel to a predetermined sensing region of a sensing device. The stick 102 provides a bar-like support structure for the absorbent material 302. One end of the absorbent 302 is attached to the surface 400 of the first rod-like support portion 402. The absorbent material 302 is attached or formed to the surface 400 using a suitable bonding material, such as an adhesive material, such as an acrylic adhesive or an epoxy adhesive, and / or mechanically engaged with the absorbent material 302. It can be attached to surface 400 by mechanical means such as a hook (not shown).

  In another embodiment shown in FIG. 6, the mechanical means is a biasing structure in the form of a spring 600 that connects to the surface 601 of the first bar 602 and extends toward the surface 603 of the rigid tip 604. Including the body and providing the absorbent material 606 with mechanical strength and tensile properties.

  Returning now to FIG. 4, the rigid tip 300 preferably functions as a resistance point when the stick 102 is inserted into the receptacle 106. The hollow receptacle channel 118 has a length dimension that is shorter than the length 404 by a certain amount between the second rod-like support portion 408 of the stick 102 and the grip portion 410 from the free end of the rigid tip portion 300 to the rim 406. . Thus, in the last part of inserting the stick 102 into the receptacle 106, the rigid tip 300 moves toward the surface 400, thereby exerting a force on the absorbent 302, resulting in compression of the absorbent 302 and a fluid sample. Extrude. The outlet port 108 perpendicular to the receptacle channel 118 is aligned with the microfluidic channel 116 of the card sensor 104.

  In the example embodiment, the second bar-like support 408 is provided with a snap feature in the form of a biasing protrusion 412 that can be received in the corresponding hole 414. An alignment feature in the form of a key 416 is also provided, which key 416 is received in a corresponding slot 418 formed in the wall of the receptacle 106. Advantageously, the snap feature and alignment feature function as an indication that the stick 102 is fully inserted and is in proper alignment.

  In an example embodiment, collecting the fluid sample by contacting the absorbent 302 with the fluid stream or by dipping the absorbent 302 in the sample after the sample is collected in the container and directly wetting the absorbent 302 Can do. All surfaces of the stick 102 except the absorbent material 302 are made of hydrophobic material (s) and only a predetermined area, ie the absorbent material 302, is wetted so that no extra sample remains on the stick 102. It is preferable to ensure this.

  Thereafter, the stick 102 is inserted into the receptacle 106. The combination of the rigid tip 300 and the support structure including the first bar-like support 402 and the second bar-like support 408 increases the mechanical strength of the stick 102 when the stick 102 is inserted into the receptacle 106. It is preferable to be able to maintain.

  The collection stick 102 also has a tapered section 411 disposed between the first bar-like support 402 and the second bar-like support 408. The dimension (here, the diameter) of the first rod-shaped support 402 is smaller than the dimension of the channel 118 of the receptacle 106, but the dimension (here, the diameter) of the second rod-shaped support 408 is substantially equal to the dimension of the channel 118. The tapered section 411 gradually changes the dimension between the first bar-like support part 402 and the second bar-like support part 408.

  Referring to FIG. 5, when the rigid tip 300 contacts the end 500 of the channel 118, the absorbent material 302 is compressed by further insertion force. The absorbent 302 continues to be compressed until the second bar 408 of the stick 102 is inserted into the receptacle 106. The alignment key 416 (FIG. 4) fits within the slot 418 (FIG. 4) and the biasing protrusion 412 (FIG. 4) is snapped into the hole 414 (FIG. 4) to prevent further pressure relief of the absorbent 302. . Accordingly, the volume dispensed from the absorbent material is preferably controllable, and it is preferable that the back flow of the fluid sample can be prevented. In this embodiment, the free end of the tip 300 is concave and is received by a corresponding convex wall 500 where the hollow channel 118 of the receptacle 106 terminates.

  In the embodiment shown in FIG. 6, the length of the spring 600 is preferably equal to or less than the uncompressed overall length of the absorbent 606, and the diameter of the spring 600 is preferably smaller than the diameter of the absorbent 606. The compression of the absorbent 606, and in this embodiment the spring 600, further causes a fluid sample collected in the absorbent 606 to be formed perpendicular to the insertion direction indicated by reference numeral 610, ie, in the receptacle 612. It is preferable to squeeze out toward an outlet port 608 positioned perpendicular to the insertion channel 611. Thereafter, the fluid sample, eg, liquid, preferably flows through a microfluidic system (eg, 614) to a respective predetermined sensing location (eg, 616, 618 on card sensor 620).

  FIG. 7 shows a schematic top view of a fluid sample collection device 700 according to another embodiment. In this embodiment, the support structure includes a first rod-like support portion 702 and a second rod-like support portion 704, a tapered portion 705, and a cover 706 around the absorbent material 708, and fluid flows into the absorbent material 707. When absorbed and collected (this may reduce the mechanical strength and tensile properties of the absorbent 707), it maintains the mechanical strength of the device 700. The cover 706 has one or more openings 709 for fluid communication with the absorbent material 707. The cover 706 is attached to the peripheral portion of the first rod-like support portion 702, and is connected to the rigid tip portion 710 via a one-way locking mechanism. The one-way locking mechanism preferably prevents the absorbent 707 from repelling after compression. This is described in more detail below with reference to FIGS.

  FIG. 8 shows a schematic top view, partially in cross section, showing the movement of the rigid tip 710 of the device 700 upon insertion into a receptacle (not shown). In the first state, where the device 700 is used for fluid sample collection, the rigid tip 710 is disposed with the protrusion 800 received in a corresponding groove 802 formed in the cover 706. In this embodiment, the protrusion 800 and the groove 802 extend in an annular shape. In different embodiments, the protrusions and / or grooves can take different forms, including one or more, preferably at least two, more preferably at least three individual protrusions, and a corresponding singular. Or it is understood that a plurality of grooves may be mentioned.

  As shown in FIG. 8, the groove 802 has a higher wall 804 facing the free end of the tip 710 than the wall 806 at the opposite location of the groove 802. Therefore, it is preferable that the tip portion 710 is prevented from falling off. At the same time, the lower wall 806 causes the tip 710 to bend in order to cause movement of the tip in the direction indicated by reference numeral 808, ie, to deflect and the protrusion 800 to disengage from the groove 802. Requires a certain force to be applied. This preferably prevents unintentional movement of the tip 710 caused by contacting or contacting the wall of a receptacle (not shown) before or during insertion. Otherwise, the absorbed sample fluid may be compressed and undesirable squeezed out.

  As shown in FIG. 9, in the second state, a rigid tip is used when the device 700 is fully inserted into a receptacle (not shown) to deliver a fluid sample to, for example, a card sensor (not shown). 710 is arranged in a state where the protrusion 800 is received in the second corresponding groove 900 formed in the cover 706. In this embodiment, the protrusion 800 and the groove 900 extend in an annular shape. In different embodiments, the protrusions and / or grooves can take different forms, including one or more, preferably at least two, more preferably at least three individual protrusions, and a corresponding singular. Or it is understood that a plurality of grooves may be mentioned. As shown in FIG. 9, the groove 900 has a wall 902 that faces the first bar-like support portion 702 and is higher than the wall 904 that is at the opposite position of the groove 900.

  The higher wall 902, together with snap and alignment features similar to those described above with reference to FIG. 4, for example, prevents further compression of the absorbent 707 and reduces the volume of fluid sample delivered. It is advantageous to facilitate control. At the same time, with the protrusion 800 received in the groove 900, the rigid cap is locked in place, thereby preferably preventing repelling of the absorbent material. Otherwise, an undesirable back flow of the fluid sample being conveyed may be caused.

  For example, as seen in FIG. 9, the rigid tip 710 of this embodiment includes an internal rod-like portion 906 that is disposed within the covering 908 and joined together at the base 910 of the tip 710. The inner bar 906 is slidably received in the inner channel 912 in the cover 706 and is of a size suitable for compressing the absorbent 707 while moving from the first state to the second state. The dimensions (here, the diameter) of the internal rod-shaped portion 906 are preferably substantially the same as the dimensions of the absorbent material 707.

  The collection delivery mechanism in the described embodiment is used to collect a fluid sample including, but not limited to, urine, water, blood, or any other type of fluid and deliver it to a predetermined sensing location of the sensing device. be able to.

  The absorbent material in the example embodiments can be modified to incorporate different forms of absorption and filtration functions. This can be done, for example, by controlling the pore size and material type of the absorbent material.

  In various embodiments, varying volumes of fluid samples can be carried by controlling the length difference between the receptacle channel and the insertion length of the collection stick.

  In example embodiments, the absorbent material can be impregnated with, for example, a desired colorimetric reagent in a dry form that changes color upon reaction with an analyte in a fluid sample. The colored solution can be delivered through the microfluidic channel to a specific area of the sensing device that performs the detection.

In the described embodiment, non-limiting material examples for each component can be given as follows.
A rod-like support structure including the first rod-like support portion, the second rod-like support portion, and the grip portion: a hydrophobic plastic in any form, such as polymethyl methacrylate (PMMA), polypropylene (PP), and the like.
Absorbent: any form of common sponge material, such as wood cellulose fiber, foamed plastic polymer, low density polyether, polyvinyl acetal (PVA), or polyester.
Biasing structure: non-corrosive material such as stainless steel or acrylonitrile butadiene styrene (ABS), PP.
Rigid tip: hydrophobic plastic of any form, such as PMMA, PP, etc.
Hollow receptacle: any form of hydrophobic plastic, eg PMMA, PP, etc.
Sensing device: any form of sensing chip that may include optical and / or electronic components. This material is preferably plastic, but can likewise be glass or silicon.
Snap function part and alignment function part: Hydrophobic plastic in any form, such as PMMA, PP, etc.

  Those skilled in the art will be able to make numerous variations and / or modifications to the invention shown in the specific embodiments without departing from the spirit or scope of the invention as described in its entirety. Is understood. Therefore, this embodiment is considered to be illustrative and not restrictive in all aspects. Further, the present invention provides any combination of features, particularly any combination of features in the claims, even if the features or combinations of features are not explicitly described in the claims or in the embodiments. Including.

  One or more of the various parts of the described embodiments can be formed separately, for example, attached to each other using a suitable glue or adhesive or mechanical means, or formed integrally. be able to.

Claims (17)

An apparatus for collecting a fluid sample, the apparatus comprising:
Collecting sticks,
An absorbent disposed on the collecting stick;
A compression mechanism that is disposed on the collection stick and compresses the absorbent while being applied with force, the compression mechanism having a non-absorbable tip of the collection stick, and the tip A compression mechanism that is movable to compress the absorbent while being applied; and
A cover for the absorbent material;
An apparatus comprising:   The apparatus of claim 1, wherein the tip is rigid.   The apparatus according to claim 1 or 2, wherein the cover is supported on the collecting stick.   The apparatus according to claim 1, wherein the cover has one or more openings for fluid communication with the absorbent material.   The apparatus of any one of Claims 1-4 further provided with the latching mechanism which connects the said front-end | tip part to the said cover.   The locking mechanism is unidirectional, and the distal end portion resists movement in a direction opposite to the first direction when moving by a predetermined distance in the first direction so as to compress the absorbent material. 6. The device of claim 5, wherein the device is adapted to be locked.   The apparatus of claim 6, wherein the locking mechanism is configured to restrict the tip from moving beyond the predetermined distance in the first direction.   The device according to claim 1, wherein the tip portion and the absorbent material have substantially the same cross-sectional dimensions.   9. The device according to any one of claims 1 to 8, comprising a snap mechanism member indicating that the device is fully inserted into the receptacle.   10. Apparatus according to any one of the preceding claims, comprising an alignment member that indicates correct alignment of the apparatus within a receptacle.   11. Apparatus according to any preceding claim, wherein the collection stick comprises a biasing member that extends at least partially within the absorbent material. A receptacle for a device for collecting a fluid sample, the receptacle comprising:
A channel for receiving the device, the channel having a wall that abuts a non-absorbing tip of the device, the tip compressing an absorbent while being forced by the wall of the channel A channel, wherein the wall of the channel is arranged to exert a force on a compression mechanism while the channel receives the device; and
An opening formed in the receptacle that is in fluid communication with the channel and is used to dispense fluid exiting the compressed absorbent;
A snap mechanism member indicating that the device is fully inserted into the receptacle and preventing pressure relief of the absorbent;
A receptacle.   13. A receptacle according to claim 12, comprising an alignment member that indicates correct alignment of the device within the receptacle.   The receptacle according to claim 12 or 13, wherein the device comprises the device according to any one of claims 1-11. An assembly for collecting a fluid sample, the assembly comprising:
Collecting sticks,
An absorbent disposed on the collecting stick;
A compression mechanism disposed on the collection stick and compressing the absorbent while being applied with force;
A cover for the absorbent material;
A receptacle for receiving the collection stick with a channel formed therein and comprising the cover;
A wall of the channel arranged to apply a force to the compression mechanism while receiving the collecting stick into the channel;
An opening formed in the receptacle that is in fluid communication with the channel and is used to dispense fluid exiting the compressed absorbent;
And the compression mechanism has a non-absorbable tip of the collection stick, the tip being movable to compress the absorbent while being applied with force.   The channel has the wall abutting the non-absorbing tip of the collection stick, the tip being movable to compress the absorbent while being forced by the wall of the channel. 16. An assembly according to claim 15, wherein: A method of collecting a fluid sample, the method comprising:
Absorbing the fluid in an absorbent material disposed on the collecting stick and provided with a cover;
Receiving the collecting stick comprising the cover in a channel formed in a receptacle;
Compressing the absorbent while receiving the collecting stick in the channel;
Dispensing the fluid exiting the compressed absorbent through an opening formed in the receptacle;
The compressing step includes applying a force to the non-absorbable tip of the collecting stick and moving the tip to compress the absorbent while applying the force to the tip. Including.