Body fluid sampler, body fluid sampling and discharging method, and blood sampling device kit

Abstract

The present invention comprises: a suction part that has a tubular member for suctioning body fluid and an orifice in communication with the tubular member; a first body that defines a first space in communication with the suction part through the orifice; and a second body that defines a second space in communication with the first space defined by the first body, has a ventilation port for providing ventilation between the second space and the outside, and possesses flexibility at a level enabling compression of at least a portion thereof. The outer surfaces of the first body and the second body respectively include a first display part and a second display part that indicate the sequence of operation for sampling the body fluid.

Description

Body fluid collector, body fluid collection and discharge method, and blood collection device kit

[0001] The present invention relates to a body fluid collector, a body fluid collection and discharge method, and a blood collection device kit, and particularly to a body fluid collector that collects body fluid using capillary action, a body fluid collection and discharge method, and a blood collection device kit.

[0002] Currently, in medical institutions and the like, tests are performed in which body fluids such as blood, lymph and saliva are collected, and diseases are diagnosed or health conditions are evaluated through testing of the collected body fluids. In addition, various structures are known for body fluid collectors that collect a trace amount of body fluid using capillary action.

[0003] Such a body fluid collector, for example, as described in Patent Document 1, comprises: a suction part having a suction port at one end, which sucks liquid into an internal quantitative space by capillary action when brought into contact with the liquid; and an expanded part, which is integrally formed with the suction part with an internal cavity communicating therebetween, has an opening at the other end, is expanded from the suction part, and does not develop capillary action. A body fluid collector in which the suction part is impregnated with a hydrophilic agent is known.

[0004] According to such a body fluid collector, by impregnating or mixing the hydrophilic agent into the resin instead of coating it, the capillary action of the suction part is increased, and the amount of intrusion into the quantitative space can be increased. Unlike the case where the hydrophilic agent is coated, the desorption of the hydrophilic agent into the collected body fluid is reduced. In addition, a specific amount of body fluid can be quantitatively sucked without visual confirmation using a marker or the like.

[0005] Japanese Patent Application Laid-Open No. 2015-54319

[0006] However, the body fluid collected by the body fluid collector needs to be discharged into a test instrument for inspection, and the body fluid collector described in Patent Document 1 requires compressing the body portion to discharge the body fluid while blocking a hole formed in the body portion.

[0007] According to such a configuration, when collecting body fluid, in order to reliably perform collection by capillary action, body fluid is collected from the suction port without blocking the air hole formed in the body portion, and when discharging the body fluid to a test device, the air hole is blocked and the body portion is compressed to discharge the body fluid.

[0008] This discharge procedure, if the air vent is not properly sealed, will result in insufficient discharge of the collected bodily fluids. This leads to a situation where the handling of the bodily fluid collection device involves both sealing and not sealing the air vent, requiring excessive caution during handling. Such handling complicates the testing process.

[0009] Therefore, the present invention has been made to solve these problems, and aims to provide a body fluid collector that can be easily handled in the inspection process, and a method for collecting and discharging body fluid using this body fluid collector. "Discharging" means pushing an object away from one place to another, and in this specification, it means bringing something that is inside out. In one embodiment, this refers to bringing the body fluid sucked into a tubular member out of the tubular member. Furthermore, compressing the air inside the body fluid collector to push out the body fluid sucked into the tubular member can also be expressed as "discharging".

[0010] The bodily fluid sampler according to the present invention, which solves the above problems, is a bodily fluid sampler for collecting bodily fluids, comprising: a suction section having a tubular member for aspirating bodily fluids and an orifice communicating with the tubular member; a first main body section defining a first space communicating with the suction section via the orifice; and a second main body section defining a second space communicating with the first space defined by the first main body section, having a vent for ventilation between the space and the outside, and having flexibility such that at least a part of it is compressible, wherein the outer surfaces of the first main body section and the second main body section each include a first display section and a second display section indicating the sequence of operations for collecting bodily fluids.

[0011] Furthermore, in the bodily fluid collector according to the present invention, the first main body is preferably a part for holding the bodily fluid collector when the bodily fluid is drawn into the suction part, and the second main body is preferably a part that is compressed when the bodily fluid drawn into the suction part is discharged.

[0012] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable that the vent is closed when the second main body is compressed in order to discharge the bodily fluid that has been drawn into the suction section.

[0013] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable that the vent is located near the second display unit, and that the operator can cover the vent with their finger when compressing the second main body of the bodily fluid collection device.

[0014] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable to have a boundary portion on the outer surface that separates the first main body portion and the second main body portion.

[0015] Furthermore, in the bodily fluid sampling device according to the present invention, it is preferable to have a first display enclosure surrounding the first display unit, or a second display enclosure surrounding the second display unit.

[0016] Furthermore, in the bodily fluid collection device according to the present invention, the suction portion has an insertion portion that is inserted into the first main body, and it is preferable that the insertion portion is inserted until it overlaps the first display portion.

[0017] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable that the suction unit draws bodily fluid into a tubular member by capillary action, and that the orifice restricts the suction of bodily fluid.

[0018] Furthermore, in the bodily fluid collection device according to the present invention, the second main body portion preferably has flexibility in the second display portion so that it can be compressed by the finger of the operator of the bodily fluid collection device, and the bodily fluid collected in the suction portion is discharged by such compression.

[0019] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable that the first main body has sufficient strength to prevent compression when the bodily fluid collection device is held by the first main body.

[0020] Furthermore, in the bodily fluid collection device according to the present invention, it is preferable that the first display unit displays the number "1" and the second display unit displays the number "2".

[0021] Furthermore, in the bodily fluid collection device according to the present invention, the bodily fluid is preferably blood.

[0022] Furthermore, in the bodily fluid collection device according to the invention, the suction portion preferably has a suction shoulder portion that is larger in diameter than the tubular member, and the surface of the suction shoulder portion preferably has a ventilation portion that extends along the extending direction of the tubular member.

[0023] Furthermore, in the bodily fluid collection device according to the invention, it is preferable that the ventilation sections are arranged at approximately equal intervals along the circumferential direction of the suction shoulder section.

[0024] Furthermore, in the bodily fluid collection device according to the invention, it is preferable that the suction shoulder portion has an inclined surface that widens toward the first main body portion at the end opposite to where the tubular member is formed.

[0025] Furthermore, in the bodily fluid collection device according to the invention, it is preferable that the tubular member and the suction shoulder portion are continuous via a continuous surface that smoothly connects the base end of the tubular member and the tip end of the suction shoulder portion.

[0026] Furthermore, the blood collection device kit according to the present invention comprises the body fluid collector and reagent cartridge described above.

[0027] Furthermore, in the blood collection device according to the present invention, it is preferable that the inner diameter of the containment portion that contains the body fluid of the reagent cartridge and the outer diameter of the surface portion are not in close contact.

[0028] Furthermore, the bodily fluid collection and discharge method according to the present invention is a method for collecting and discharging bodily fluids using the bodily fluid collection device described above, comprising the steps of: holding the bodily fluid collection device with the first display unit and drawing the bodily fluids into the suction unit by capillary action; and compressing the second main unit while blocking the vent of the second display unit to discharge the bodily fluids drawn into the suction unit.

[0029] According to the present invention, the outer surfaces of the first and second main body portions each include a first display portion and a second display portion, respectively, which indicate the sequence of operations for collecting bodily fluids. The second display portion has a vent that allows air to circulate between the space and the outside. Therefore, when collecting bodily fluids, the operation is performed while holding the first display portion, and when discharging bodily fluids, the operation is performed while holding the second display portion. This allows for proper opening and closing of the vent, thereby simplifying the inspection process. In some cases, the operator may perform the operation without understanding the need to open and close the vent, but even in such cases, it is possible to properly open and close the vent. Furthermore, by tilting the angle of the boundary portion with respect to the width direction of the tubular member, it is possible to guide the operator to hold the bodily fluid collector at an angle that facilitates the aspiration of bodily fluids.

[0030] A plan view of a body fluid collector according to the first embodiment of the present invention. A front view of a body fluid collector according to the first embodiment of the present invention. A plan view of the suction section of a body fluid collector according to the first embodiment of the present invention. A plan view of the main body of a body fluid collector according to the first embodiment of the present invention. A plan view of a body fluid collector according to the second embodiment of the present invention. A perspective view of a body fluid collector according to the third embodiment of the present invention. An exploded view of a body fluid collector according to the third embodiment of the present invention. A diagram showing the state of use of a blood collection device kit according to an embodiment of the present invention.

[0031] The bodily fluid collection device according to the present invention will be described below with reference to the drawings. Note that the following embodiments are not intended to limit the invention as described in each claim, and not all combinations of features described in the embodiments are necessarily essential to the solution of the invention.

[0032] [First Embodiment] Figure 1 is a plan view of a body fluid collector according to the first embodiment of the present invention, Figure 2 is a front view of a body fluid collector according to the first embodiment of the present invention, Figure 3 is a plan view of the suction section of a body fluid collector according to the first embodiment of the present invention, and Figure 4 is a plan view of the main body of a body fluid collector according to the first embodiment of the present invention.

[0033] As shown in Figures 1 and 2, the bodily fluid collector 100 according to this embodiment includes a suction unit 10 for collecting and discharging bodily fluids, and a main body unit 50 for performing the suction and discharge operations.

[0034] As shown in Figure 3, the suction unit 10 comprises a tubular member 11 for aspirating bodily fluids such as blood, a suction shoulder 14 which is continuous with the tubular member 11 via a small-hole-shaped orifice 12 and is formed to be wider than the tubular member 11, and an insertion part 21 into which the suction unit 10 is inserted into the main body 50. The tubular member 11 has a suction port 13 at its tip and a through passage that penetrates from the suction port 13 through the orifice 12 to the insertion part 21. The orifice 12 has the function of limiting the amount of bodily fluid aspirated from the suction port 13 so that it can be held inside the tubular member 11.

[0035] In this embodiment, the bodily fluid collected by the bodily fluid collector 100 is expected to be discharged into a reagent cartridge 201, etc. However, the reagent cartridge 201, etc. may have a resin or aluminum seal at the injection site. In such cases, the seal can be punctured and opened using the tip of the suction part 10, but if the area around the suction part and the seal are in close contact as a result, it may be impossible or difficult to discharge the bodily fluid. Therefore, by providing a suction shoulder 14, the punctured area can be enlarged when the seal is punctured. The shape of the suction shoulder 14 does not need to be particularly limited as long as it is larger than the diameter of the tubular member 11, but it is preferable to have a chamfered shape so that the hole can be further enlarged with the suction shoulder 14 after it has been punctured by the tubular member 11. However, even after the suction shoulder portion 14 has penetrated the seal and entered the containment portion 202 where the bodily fluids are discharged, the outer circumference of the suction shoulder portion 14 and the inner circumference of the containment portion 202 are in close contact (specifically, in this case, they are in close contact with the seal remaining on the inner circumference). This prevents air from escaping from the containment portion 202, creating positive pressure inside, which can make it impossible or difficult to discharge the bodily fluids. Therefore, by providing a ventilation portion 15 that connects the inside and outside of the containment portion 202, air pressure can be released when the bodily fluids are discharged, making it possible to discharge the bodily fluids smoothly. The ventilation portion 15 is also an effective measure even if the insertion point is not sealed with a resin or aluminum seal beforehand. Even if the inner circumference of the containment portion 202 and the outer circumference of the suction shoulder portion 14 are in close contact, air pressure can be released, making it possible to discharge the bodily fluids smoothly.

[0036] If a liquid such as a sample diluent is pre-contained inside the containment section 202 for discharging collected bodily fluids, there is a risk that the discharge process will be incomplete if the tip of the suction section comes into contact with the liquid, aspirating both the discharged bodily fluid and the liquid after the fluid has been discharged. Therefore, it is preferable to discharge the liquid into the containment section while the tip of the suction section 10 is fixed so that it does not reach the liquid surface. Specifically, it is preferable to design the device so that the top surface of the reagent cartridge 201 or the like and the bodily fluid collector overlap in a plane, so that the tip of the suction section only enters the containment section a certain distance in the vertical direction.

[0037] Furthermore, when discharging the body fluid collected in the reagent cartridge 201, if the body fluid collector becomes unstable, there is a risk that the reagent cartridge 201 may tip over if a force is applied at an angle to the vertical when the main body is compressed for discharging. For this reason, it is desirable for the body fluid collector to be approximately vertical, and from this perspective, it is desirable for the area around the suction part and the seal to be in close contact. However, as mentioned above, this would pose the risk that the body fluid could not be discharged at all.

[0038] Furthermore, the volume of the through passage within the tubular member 11 is configured to ensure a sufficient amount of bodily fluid necessary for the examination. Specifically, for example, it can be any amount between 5 and 200 μl, and a volume of approximately 10 to 50 μl is preferable. In addition, the diameter of the orifice 12 is preferably formed to the extent that it can transmit pressure fluctuations associated with the operation of the main body 50 into the tubular member 11, while preventing the aspirated bodily fluid from leaking to the main body 50.

[0039] The amount of body fluid collected by the body fluid collector 100 according to this embodiment can be set to any amount by providing an orifice 12. For example, it can be any amount between 5 and 200 μl. Specifically, for example, it can be 20 μl or 40 μl. The inner diameter of the tubular member 11 may be 0.5 mm to less than 2.0 mm, preferably 0.5 to 1.5 mm, more preferably 0.8 to 1.2 mm, and even more preferably approximately 1 mm. The shape may be a straight cylindrical shape or a tapered shape, but preferably a straight shape with a beveled tip. The inner diameter of the orifice 12 is preferably smaller than the inner diameter of the tubular member 11. For example, if the inner diameter of the tubular member 11 is 0.8 mm or more, the orifice 12 should be 0.3 to 0.7 mm, preferably approximately 0.5 mm. Its shape may be straight or tapered.

[0040] Furthermore, the suction section 10 is rigid enough to collect a body fluid and accommodate the body fluid within the tubular member 11. For example, polystyrene (PS), polyethylene-terephthalate (PET), polycarbonate (PC), polypropylene (PP), rigid polyvinyl chloride (PVC, so-called rigid polyvinyl chloride or rigid PVC), ABS resin and the like are suitably used.

[0041] As shown in FIG. 4, the main body section 50 includes a first main body section 20 that defines a first space 22 communicating with the suction section 10 via the orifice 12, and a second main body section 30 that defines a second space 32 communicating with the first space 22 defined by the first main body section 20 and includes a vent 31 that ventilates the internal space of the main body section 50 to the outside. The main body section 50 is formed in a flat shape and has a shape that can be easily compressed with a finger. In addition, for example, when a large volume of body fluid is to be aspirated, the main body section 50 may be formed into a balloon shape or a cylindrical shape to enlarge the container inside the main body section 50. Specifically, the compressible volume of the main body section 50 only needs to be at least equal to or larger than the volume of the aspirated body fluid (that is, substantially the volume inside the tubular member 11), and is preferably twice or more the aforementioned volume.

[0042] The first main body section 20 is formed with an insertion section 25 into which the inserted section 21 of the aforementioned suction section 10 can be inserted. The first main body section 20 has higher rigidity than the second main body section 30 when the inserted section 21 of the suction section 10 is inserted into the insertion section 25.

[0043] Furthermore, as shown in Figures 1 and 2, convex first display portions 23 and second display portions 33 are formed on both the front and back outer surfaces of the first main body portion 20 and the second main body portion 30. "1" is indicated on the first display portion 23, and "2" is indicated on the second display portion 33. Furthermore, the first display portion 23 and the second display portion 33 are respectively formed with a first display surrounding portion 24 and a second display surrounding portion 34 that surround the aforementioned indications of "1" and "2", respectively. The second display surrounding portion 34 is arranged so as to surround the ventilation opening 31 together with the indication of "2". When compressing the second main body portion 30, the second display portion 33 and the ventilation opening 31 only need to be able to push out enough air to discharge the body fluid in the tubular member 11, and their positions may be arranged as appropriate; however, it is preferable that they are arranged not near both ends of the second main body portion 30, but on the end side slightly opposite to the first main body portion 20 from the central portion.

[0044] Furthermore, the first display portion 23 and the second display portion 33 are each curved such that the central portion is recessed with respect to the longitudinal direction of the main body portion 50, thereby ensuring operability during the body fluid aspiration and discharge operations described below.

[0045] The main body portion 50 is formed of a softer member compared to the aforementioned suction portion 10, such that at least a part thereof has flexibility sufficient to be compressible. For example, polyethylene (Polythene: PE), silicone resin, polyurethane (Polyurethane: PU), elastomer, nitrile rubber (Nitrile Rubber: NBR), soft polyvinyl chloride (Polyvinyl Chloride: PVC, so-called soft polyvinyl chloride or soft PVC), thermoplastic plastic, and thermoplastic elastomer (TPE) are preferably used.

[0046] Furthermore, a boundary portion 40 is formed at the boundary between the first main body portion 20 and the second main body portion 30. The boundary portion 40 extends along the width direction of the main body portion 50 so as to be substantially orthogonal to the extending direction of the tubular member 11.

[0047] Furthermore, when the length of the tubular member 11 of the first main body 20 in the extending direction is 10, the length of the insertion portion 21 along the same direction should be 2 to 10 mm, preferably 3 to 9 mm, and more preferably 4 to 8 mm. Also, the length of the second main body 30 along the same direction is not particularly limited, but it is preferable that it be formed to be slightly larger than the pad of the operator's finger. Furthermore, it is preferable that the first main body 20 is designed to be shorter than the second main body 30 in the same direction.

[0048] [Second Embodiment] In the first embodiment of the body fluid collector 100 described above, the case in which the boundary portion 40 is formed along the width direction of the main body portion 50 was described. The second embodiment of the body fluid collector 101 described next describes an embodiment of the boundary portion having a different form from the first embodiment. Note that the same or similar components as in the first embodiment described above are denoted by the same reference numerals and their description is omitted.

[0049] Figure 5 is a plan view of a body fluid collection device according to the second embodiment.

[0050] As shown in Figure 5, the body fluid collector 101 according to this embodiment, like the body fluid collector 100 according to the first embodiment, has a boundary portion 41 formed between the first main body portion 20' and the second main body portion 30', but the boundary portion 41 is arranged at an angle with respect to the width direction of the main body portion 50'. The angle of inclination should be approximately 25 to 75° with respect to the width direction of the main body portion 50', preferably approximately 30 to 70°, more preferably approximately 40 to 65°, even more preferably approximately 55 to 65°, and preferably approximately 60°.

[0051] Furthermore, the edges adjacent to the boundary portion 41 of the first display enclosure portion 24' of the first display portion 23' and the second display enclosure portion 34' of the second display portion 33' are also formed with an inclination corresponding to the inclination of the boundary portion 41.

[0052] The bodily fluid collector 101 formed in this manner according to this embodiment can encourage the operator to operate the bodily fluid collector 101 by tilting it so that the boundary portion 41 is horizontal when collecting bodily fluids. As a result, when the operator holds the first main body portion 20', the operator can be guided to hold the bodily fluid collector 101 at an angle that facilitates suction of bodily fluids, specifically, at an angle such that the suction shoulder portion 14 is diagonally downward with respect to the vertical direction relative to the tip of the suction portion. Furthermore, it is possible to prevent the operator from accidentally blocking the vent 31 in the second main body portion 30' when holding the first main body portion 20'. At this time, by also tilting the first display enclosure portion 24', the operator can be guided to align their fingers with the first display enclosure portion 24'.

[0053] [Third Embodiment] In the first and second embodiments of the body fluid collectors 100 and 101 described above, the case in which the boundary portion 40 is formed in the main body portion 50 was described. The third embodiment of the body fluid collector 102, which will be described next, describes an embodiment of a body fluid collector having a different form from the first and second embodiments. Note that the same or similar components as in the first and second embodiments described above are denoted by the same reference numerals and their description is omitted.

[0054] Figure 6 is a perspective view of a body fluid collector according to the third embodiment of the present invention, and Figure 7 is an exploded view of the body fluid collector according to the third embodiment of the present invention.

[0055] As shown in Figure 8, the body fluid collector 102 according to this embodiment constitutes a blood collection device kit 200 together with the reagent cartridge 201. As shown in Figure 6, in the body fluid collector 102 according to this embodiment, the suction unit 10a and the first main body unit 20a are integrally formed. Unlike the body fluid collectors 100 and 101 according to the first and second embodiments described above, the second main body unit 30a is constructed separately from the first main body unit 20a, and the first main body unit 20a and the second main body unit 30a constitute the main body unit 50a. The main body unit 50a is formed in a flattened elliptical cylindrical shape. Note that the suction unit 10a and the first main body unit 20a may be constructed separately.

[0056] A tubular member 11a is formed at the tip of the suction section 10a, and the tubular member 11a and the first main body 20a are continuous via a suction shoulder 14a. The tubular member 11a is a tubular member having an opening 13 at its tip, and has a beveled portion 13a that tapers towards the tip. The suction shoulder 14a has a first suction shoulder 16, a surface portion 17, and a second suction shoulder 18 that smoothly connect to the base end of the tubular member 11a, and the second suction shoulder 18 is connected to a vertical wall portion 19 formed on the end face of the first main body 20a. The first suction shoulder 16 has a scale portion 16a formed thereon, which serves as a marker to indicate when to suction the bodily fluids aspirated from the opening 13 up to the scale portion 16a. Preferably, the tubular member 11a is made transparent or semi-transparent so that the aspirated bodily fluids can be easily seen.

[0057] The surface portion 17 is formed with a larger diameter than the tubular member 11a, and ventilation portions 15 extending along the extending direction of the tubular member 11a are formed on the surface portion 17 and the second suction shoulder portion 18. Preferably, multiple ventilation portions 15 are formed at approximately equal intervals along the circumferential direction of the suction shoulder portion 14a. In the illustrated example, the case in which two ventilation portions 15 are formed along the circumferential direction has been described, but the number of ventilation portions 15 is not limited to this and can be increased or decreased as appropriate. Furthermore, the ventilation portions 15 are not limited to being formed in a groove shape; the surface portion 17 of the suction shoulder portion 14a may be formed in a rib shape, and the space between these ribs may be configured as the ventilation portion 15.

[0058] The ventilation portion 15 only needs to be able to release air pressure when performing a discharge operation, and its shape is not particularly limited, but for example, it may be formed from the first suction shoulder portion 16 to the second suction shoulder portion 18, from the first suction shoulder portion 16 to the end portion of the first main body portion 20a on the tubular member 11 side, at the second suction shoulder portion 18, or at the end portion of the first main body portion 20a on the tubular member 11 side. If a second suction shoulder portion is formed, it is preferable that it is formed from the first suction shoulder portion 16 to the second suction shoulder portion 18, or at the second suction shoulder portion 18, and more preferably from the first suction shoulder portion 16 to the second suction shoulder portion 18. If the second suction shoulder portion 18 is not formed, it is preferable that it is formed from the first suction shoulder portion 16 to the end portion of the first main body portion 20a on the tubular member 11 side, or at the end portion of the first main body portion 20a on the tubular member 11 side, and more preferably from the first suction shoulder portion 16 to the end portion of the first main body portion 20a on the tubular member 11 side.

[0059] The surface portion 17 has the function of pressing the sealing piece, such as film, that has pierced the sealing seal attached to the opening of the reagent cartridge 201's storage portion 202 against the inner wall of the storage portion 202 where the fluid is discharged, and / or fixing the body fluid collector 102 according to this embodiment. By pressing the sealing piece, such as film, against the inner wall, it is possible to prevent the pierced film sealing piece from falling into the storage portion 202, and / or to press the edge of the pierced film against the inner wall of the storage portion 202, thereby preventing body fluids such as blood from adhering to the edge of the film, or even if body fluids do adhere to the edge of the film, the film will remain on the inner wall side of the storage portion 202, thereby reducing the risk of infection. Furthermore, by fixing the body fluid collector 102 according to this embodiment to the storage portion 202, it is possible to facilitate the discharge of body fluids or reduce the risk of tipping over the reagent cartridge 201.

[0060] The second suction shoulder portion 18 is particularly effective when the length of the width of the surface portion 17 perpendicular to the extending direction of the suction portion 10a is shorter than the length of the cross-section of the end of the first main body portion 20a on the suction portion 10a side. By forming it in this way, a vertical wall portion 19 can be formed on the end face of the first main body portion 20a, and the body fluid collector 102 according to this embodiment can be fixed by bringing the second suction shoulder portion 18 together with the top surface of the receiving portion 202 for the body fluid discharge destination such as the reagent cartridge 201. Furthermore, since the ventilation portion 15 extends to the second suction shoulder portion 18, air pressure can be released when discharging body fluid, making it possible to discharge body fluid smoothly.

[0061] Furthermore, the length of the cross-section of the surface portion 17 is preferably determined by the inner diameter of the discharged storage portion 202, as described above, and its length can be increased or decreased as appropriate. For example, it is conceivable that the length may be increased, in which case, if the end face of the first main body portion 20a on the suction portion 10a side is substantially elliptical in shape, the width of the cross-section of the surface portion 17 and the length of the minor axis of the end face of the first main body portion 20a on the suction portion 10a side may be the same. However, by providing the ventilation portion 15 to extend to the vertical wall portion 19 in the major axis direction, the second suction shoulder portion 18 can be omitted. In addition, in this embodiment, the case in which the cross-section of the surface portion 17 is substantially circular will be described, but it is preferable that the shape matches the shape of the storage portion 202 of the reagent cartridge 201 that stores the body fluid to be discharged. For example, if the storage portion 202 is elliptical in shape, it is preferable that the cross-sectional shape of the surface portion 17 be similarly elliptical.

[0062] In this embodiment, the body fluid collector 102 may have the ventilation portion 15 extended to the end of the first main body portion 20a without forming the second suction shoulder portion 18. In this configuration, the inner wall near the ventilation portion 15 of the first main body portion 20a becomes thicker, and the first space 22 becomes narrower or the first main body portion 20a becomes longer by the amount of thickness. However, this is suitable when it is desired to stabilize the tubular member 11a in a substantially vertical direction by ensuring that the vertical wall portion 19 and the top surface of the reagent cartridge 201 are in close contact when the body fluid collector 102 is inserted into the reagent cartridge 201. For example, this advantage is more likely to occur when the inner diameter of the receiving portion 202 where the reagent cartridge 201 is discharged is short. Furthermore, in this embodiment, the body fluid collector 102 may have a cross-sectional length smaller than the inner diameter of the receiving portion 202, as long as the second suction shoulder portion 18 can be fixed to the opening portion of the receiving portion 202 of the reagent cartridge 201. This configuration only requires the ventilation portion 15 to be formed near the second suction shoulder portion 18, and further reduces the material cost of the surface portion 17. This advantage is particularly noticeable when the inner diameter of the receiving portion 202, the discharge destination of the reagent cartridge 201, is large.

[0063] Furthermore, as shown in Figure 7, the bodily fluid sampler 102 according to this embodiment has a second display unit 33a positioned on the end face of the second main body 30a. A ventilation opening 31 is formed near the second display unit 33a. The second main body 30a is formed in a bottomed cylindrical shape having a bottom 34a and a wall 35a rising from the outer edge of the bottom 34a.

[0064] The first main body portion 20a and the second main body portion 30a are configured to fit together, and are joined by fitting the insertion portion 21a of the first main body portion 20a into the opening of the second main body portion 30a. Through this fitting, the first space 22, which is the internal space of the first main body portion 20a, and the second space 32, which is the internal space of the second main body portion 30a, form a single integrated internal space.

[0065] The suction portion 10a and the first main body portion 20a are formed from a rigid material, and suitable materials include, for example, polystyrene (PS), polyethylene terephthalate (PET), polycarbonate (PC), polypropylene (PP), rigid polyvinyl chloride (PVC, also known as rigid PVC), and ABS resin.

[0066] Furthermore, the second main body portion 30a is made of a softer material than the suction portion 10a and the first main body portion 20a described above, so as to have a degree of flexibility that allows it to be compressed. For example, polyethylene (PE), silicone resin, polyurethane (PU), elastomer, nitrile rubber (NBR), soft polyvinyl chloride (PVC, also known as soft PVC), thermoplastic plastic, thermoplastic elastomer (TPE), etc., are suitably used.

[0067] The bodily fluid collector 102 formed in this manner according to this embodiment is suitably used to discharge the collected bodily fluid into a reagent cartridge 201 or the like after collection and to input it into an allergy testing device or the like. In this case, when discharging the sample into the storage section 202 of the reagent cartridge 201, the tubular member 11a is used to pierce the film member sealed at the opening of the storage section 202 of the reagent cartridge 201, thereby discharging the sample into the storage section 202.

[0068] At this time, by forming a first suction shoulder portion 16 on the tip side of the suction shoulder portion 14a, the edge of the punctured film member is guided towards the inner wall of the housing portion 202, and the surface portion 17 of the suction shoulder portion 14a presses it against the inner wall of the housing portion 202, thereby preventing fragments of the film member from falling into the housing portion 202 due to the puncture. In this embodiment, it is preferable that the surface portion 17 of the body fluid collector 102 and the inner wall of the housing portion 202 of the reagent cartridge 201 are not in close contact. The dimensional difference should be such that it is possible to press the punctured film member against the inner wall of the housing portion 202, and can be appropriately selected considering the feel of use. For example, it is preferable to have a difference of about 0.3 mm to 1.2 mm, preferably 0.3 mm to 1.0 mm, more preferably 0.6 mm to 0.8 mm, and in this case, it is even preferable that the thickness of the film member is 0.1 mm. In other words, considering the thickness of the film member, it is preferable that the difference between the surface portion 17 and the inner wall side surface of the film member when the film member adheres to the inner wall of the housing portion 202 is 0.2 mm to 1.0 mm, preferably 0.3 mm to 0.8 mm, and more preferably 0.4 mm to 0.6 mm.

[0069] Furthermore, when inserting the body fluid sampler 102 or a pipette tip from an analyzer into the containment section 202 of the reagent cartridge 201, there is a possibility that the punctured edge of the film material may become entangled with the pipette tip, creating positive pressure. There is also a possibility that body fluids such as blood may adhere to the punctured edge of the film material. In that case, there is a risk that the user may come into contact with blood when removing the reagent cartridge 201 from the analyzer, or that contamination may occur during testing and measurement, potentially affecting the test and measurement results. Therefore, in order to avoid such problems, the film material attached to the containment section 202 needs to have the largest possible holes, and it is preferable that the outer diameter shape of the surface portion 17 is also formed with this in mind.

[0070] Furthermore, since a second suction shoulder portion 18 is formed on the base end side of the suction shoulder portion 14a which is continuous with the first main body portion 20a, it is possible to prevent the first main body portion 20a and the reagent cartridge 201 from coming into close contact when the body fluid collector 102 is inserted into the storage portion 202 of the reagent cartridge 201. In addition, since a ventilation portion 15 is formed on the surface portion 17 of the suction shoulder portion 14a, the back pressure associated with the injection of the sample into the body fluid collector 102 is appropriately released, making the injection process smoother.

[0071] Furthermore, a ventilation opening 31 is formed in the bottom 34a of the second main body 30a, and in this embodiment, when discharging bodily fluids, the end of the second main body 30a is pushed in to close the ventilation opening 31.

[0072] Next, a method for collecting and discharging bodily fluids using the bodily fluid collectors 100, 101, and 102 according to the first to third embodiments will be described.

[0073] First, the fingertip or other area of ​​the patient from which the bodily fluid sample will be collected is punctured with a lancet (lancet device). Then, the suction port 13 of the bodily fluid collector 100, 101, 102 according to the first to third embodiments is brought close to the bleeding from the punctured wound to collect the bodily fluid.

[0074] At this time, the body fluid is collected while holding the first main body parts 20, 20', and 20a. By holding the first main body parts 20, 20', and 20a, the vents 31 formed in the second display parts 33, 33', and 33a are not blocked, so that the body fluid can be drawn into the suction parts 10, and 10a by capillary action. Furthermore, since the first display parts 23, and 23' have rigidity due to the insertion part 21 of the suction part 10 being inserted into them, the main body parts 50, and 50' are not accidentally compressed during the suction operation, and suction by capillary action can be performed smoothly. In addition, since the first main body part 20a is integrally formed with the suction part 10a and has a predetermined rigidity, the main body part 50a is not accidentally compressed during the suction operation. Moreover, since the first display parts 23, 23', and 23a are marked with "1", it is possible to encourage the user to first hold the first display parts 23, 23', and 23a marked with "1" during the body fluid collection and discharge process. In this case, the body fluid collector 101 according to the second embodiment can be operated by tilting it so that the boundary portion 41 is horizontal, making it possible to handle the body fluid collector 101 in the optimal posture for collecting body fluid by capillary action.

[0075] Next, when discharging the bodily fluids collected by the bodily fluid collectors 100, 101, and 102 according to the first to third embodiments, the bodily fluids collected by the suction unit 10 are discharged by compressing the second display units 33, 33', and 33a formed on the second main body units 30, 30', and 30a while holding the second main body units 30, 30', and 30a. At this time, since the second display units 33, 33', and 33a have vents 31, compressing the second display units 33, 33', and 33a with a finger simultaneously closes the vents 31. As a result, the pressure fluctuation inside the main body units 50, 50', and 50a caused by the compression of the second main body units 30, 30', and 30a makes it possible to discharge the bodily fluids collected by the suction unit 10, and 10a from the suction port 13. The volume of the second main body parts 30, 30', and 30a to be compressed must be at least the same as the volume of the liquid to be discharged, i.e., the volume of the body fluid collected by the body fluid collectors 100, 101, and 102, but it is sufficient if it is 1.5 times or more, preferably 2 times or more, more preferably 3 times or more, and even more preferably 5 times or more. In other words, the compressible volume of the second main body parts 30, 30', and 30a should be at least 1.5 times the volume of the tubular members 11 and 11a, preferably 2 times or more, more preferably 3 times or more, and even more preferably 5 times or more. Specifically, for example, assuming that the volume of the liquid to be discharged is 20 to 100 μl, the volume of the second main body parts 30, 30', and 30a should be 0.5 to 2.5 cm³. ３ If available, 0.8-1.8 cm ３ Preferably, 1.0 to 1.5 cm ３ It is even more preferable that this is the case. Also, the volume inside the main body portions 50, 50', and 50a is, for example, 1.0 to 3.0 cm³. ３ If available, 1.5 to 2.5 cm. ３ Preferably, 1.8 to 2.2 cm ３ It is even more preferable if the second main body parts 30, 30', and 30a are compressible and flexible, so the main body parts 50, 50', and 50a can be easily compressed. Furthermore, since the second display parts 33, 33', and 33a are marked with "2", in the process of collecting and discharging bodily fluids, it is possible to encourage the user to hold the second display parts 33, 33', and 33a marked with "2" when discharging.

[0076] As described above, the body fluid collection and discharge method using the body fluid collectors 100, 101, and 102 according to the first to third embodiments makes it possible to appropriately guide the operator during sample collection and discharge, enabling testing to be performed easily and with fewer errors. Furthermore, since the first body parts 20, 20', 20a and the second body parts 30, 30', 30a have the flexibility necessary for the main body parts 50, 50', 50a in the collection and discharge processes, the burden on the operator during handling in the testing process can be reduced.

[0077] In addition, while the bodily fluid sampling devices 100, 101, and 102 according to the first to third embodiments described above have been explained in the case where the main body portions 50, 50', and 50a are formed in a flattened shape, the shape of the main body portions 50, 50', and 50a is not limited to these and may be formed in various shapes. Furthermore, while the cases in which the first display portions 23, 23', and 23a and the second display portions 33, 33', and 33a are displayed as "1" and "2" respectively have been explained, the cases are not limited to these and various display methods can be adopted as long as the order of operations can be properly understood. It is clear from the description of the claims that such modified or improved forms may also be included in the technical scope of the present invention.

[0078] 10, 10a Suction section, 11, 11a Tubular member, 12 Orifice, 13 Suction port, 14, 14a Suction shoulder, 20, 20', 20a First main body, 21 Insertion section, 22 First space, 23, 23', 23a First display section, 24, 24' First display enclosure, 25 Insertion section, 30, 30', 30a Second main body, 31 Ventilation opening, 32 Second space, 33, 33', 33a Second display section, 34, 34' Second display enclosure, 40, 41 Boundary section, 50, 50', 50a Main body, 100, 101, 102 Body fluid collector

Claims

1. A body fluid collector for collecting body fluids, comprising: a suction section having a tubular member for aspirating body fluids and an orifice communicating with the tubular member; a first main body section defining a first space communicating with the suction section via the orifice; and a second main body section defining a second space communicating with the first space defined by the first main body section, having a vent for ventilation between the space and the outside, and having at least a portion of the second main body section having flexibility to the extent that it can be compressed; and the outer surfaces of the first main body section and the second main body section each include a first display section and a second display section indicating the sequence of operations for collecting body fluids.

2. The body fluid collector according to claim 1, wherein the first main body is a part for holding the body fluid collector when drawing body fluid into the suction part, and the second main body is a part that is compressed when discharging the body fluid drawn into the suction part.

3. The bodily fluid collector according to claim 1 or 2, wherein the vent is closed when the second main body is compressed in order to discharge the bodily fluid sucked into the suction section.

4. The body fluid collector according to claim 3, wherein the vent is located near the second display section, and the operator can cover the vent with their fingers when compressing the second main body section with their fingers.

5. The bodily fluid collection device according to claim 1 or 2, having a boundary portion on its outer surface that separates the first main body portion from the second main body portion.

6. The bodily fluid sampler according to claim 1 or 2, having a first display enclosure surrounding the first display unit, or a second display enclosure surrounding the second display unit.

7. The bodily fluid collection device according to claim 1 or 2, wherein the suction portion has an insertion portion that is inserted into the first main body portion, and the insertion portion is inserted until it overlaps the first display portion.

8. The body fluid collector according to claim 1 or 2, wherein the suction section draws body fluid into a tubular member by capillary action, and the orifice restricts the suction of body fluid.

9. The body fluid collector according to claim 1 or 2, wherein the second main body has flexibility in the second display section that allows it to be compressed by the fingers of the operator of the body fluid collector, and by such compression, the body fluid collected in the suction section is discharged.

10. The body fluid collector according to claim 1 or 2, wherein the first main body has sufficient strength to prevent compression when the body fluid collector is held by the first main body.

11. The body fluid collection device according to claim 1 or 2, wherein the first display unit displays the number "1" and the second display unit displays the number "2".

12. The body fluid collector according to claim 1 or 2, wherein the body fluid is blood.

13. The body fluid collector according to claim 1, wherein the suction portion has a suction shoulder portion that is larger in diameter than the tubular member, and the surface of the suction shoulder portion has a ventilation portion that extends along the extending direction of the tubular member.

14. The bodily fluid collection device according to claim 13, wherein the ventilation sections are arranged at substantially equal intervals along the circumferential direction of the suction shoulder section.

15. The body fluid collector according to claim 13, wherein the suction shoulder portion comprises a second suction shoulder portion that expands in diameter toward the first main body portion at the end opposite to where the tubular member is formed.

16. The body fluid collector according to claim 13, wherein the suction shoulder portion comprises a first suction shoulder portion that smoothly connects the base end of the tubular member and the tip of the suction shoulder portion.

17. A blood collection device kit having a body fluid collector and a reagent cartridge according to any one of claims 1 to 16.

18. The blood collection device kit according to claim 17, characterized in that the inner diameter of the containment portion of the reagent cartridge for containing bodily fluids and the outer diameter of the surface portion of the bodily fluid collector are not in close contact.

19. A method for collecting and discharging body fluid using a body fluid collector according to claim 1, comprising the steps of: holding the body fluid collector with the first display unit and drawing the body fluid into the suction unit by capillary action; and compressing the second main unit while blocking the vent of the second display unit to discharge the body fluid drawn into the suction unit.

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