Blood sampling device and blood sampling storage device

Abstract

The invention provides a blood sampling device and a blood sampling storage device which can properly sample blood through a simple structure. This blood sampling device (1) is provided with a flow path (R) for guiding collected blood to a storage container (T), and is provided with: a housing (20); a blade (30) capable of protruding from the housing (20) and moving so as to cut the skin in one direction; a negative pressure generation cylinder (40) for generating negative pressure in the housing (20) by the movement of the plunger (41); and a trigger member (50) housed in the housing (20) and operating at the start of blood collection, the trigger member (50) being configured so as to be engaged with the plunger (41) and the blade (30) to restrict the movement of both the plunger (41) and the blade (30), and allowing the movement of the blade (30) and the plunger (41) when the engagement of both the plunger (41) and the blade (30) is released.

Description

Technical Field

[0001] The present invention relates to a blood sampling device and a blood sampling storage device. Background Art

[0002] Patent Documents 1 to 3 disclose blood sampling devices for collecting body fluids such as blood from a subject.

[0003] Patent Document 1: Japanese Patent Application No. 2012-519052

[0004] Patent Document 2: Japanese Patent Application No. 2018-534541

[0005] Patent Document 3: Japanese Patent Application No. 2019-505282

[0006] This type of blood collection device needs to take the collected blood into the device. Specifically, the blood is collected into the blood collection device by making the blood collection device close to the skin of the subject and creating a negative pressure inside the blood collection device.

[0007] One method of creating a negative pressure inside the blood collection device is to use a "vacuum chamber having an internal pressure lower than atmospheric pressure" as described in Patent Document 1. However, the method using a vacuum chamber has the trouble of preparing an internal pressure lower than atmospheric pressure in advance.

[0008] As another method of creating a negative pressure inside a blood collection device, Patent Documents 2 and 3 describe methods of generating a vacuum by "volume change when a plunger moves". Specifically, Patent Document 2 discloses a method of generating a vacuum by using a plunger when a piercing element pierces the skin and the piercing element is withdrawn. In addition, Patent Document 3 discloses a method of generating a vacuum inside a sealed portion by pulling a lancet that has been extended after a working mechanism is deployed.

[0009] However, the blood collection devices disclosed in Patent Documents 2 and 3 require separate preparation of a component that serves as a trigger for the "skin piercing action" and a component that serves as a trigger for the "vacuum generation action". Therefore, the blood collection devices disclosed in Patent Documents 2 and 3 require a large number of components, so there is room for improvement from the perspective of manufacturing cost and / or manufacturing efficiency. Summary of the invention

[0010] Therefore, an object of the present disclosure is to provide a blood sampling device and a blood sampling storage device that can more appropriately perform blood sampling with a simple structure.

[0011] In order to solve the above-mentioned problems, the blood sampling device disclosed in the present invention is a blood sampling device having a flow path for guiding the collected blood to a storage container, wherein the device comprises:

[0012] case;

[0013] a blade capable of moving in a manner of protruding from the housing and cutting the skin in one direction;

[0014] a negative pressure generating cylinder for generating negative pressure in the housing by movement of a plunger; and

[0015] The trigger component is housed in the housing and operates when blood sampling begins.

[0016] The trigger components are composed of:

[0017] The plunger and the blade are locked to limit the movement of the plunger and the blade.

[0018] When the locking of both the plunger and the blade is released, the movement of the blade and the plunger is permitted.

[0019] The blood collection and storage device disclosed in the present invention comprises:

[0020] The above-mentioned blood collection device; and

[0021] The storage container is located on the gravity direction side when the blood collection device is adhered to the skin, and stores the blood collected by the blood collection device.

[0022] According to the present disclosure, it is possible to provide a blood sampling device and a blood sampling storage device that can more appropriately perform blood sampling with a simple structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 (a) is a stereoscopic view of the blood collection device of the present invention as viewed from above, Figure 1 (b) is a stereoscopic view of the blood collection device of the present invention observed from below.

[0024] Figure 2 (a) is a three-dimensional view of the interior of the blood collection device disclosed in the present invention, Figure 2 (b) is along Figure 2 A cross-sectional view taken along line bb in (a).

[0025] Figure 3 (a) is along Figure 1 A cross-sectional view obtained by cutting along line ii of (a), Figure 3 (b) is the state where the button is pressed along Figure 1 A cross-sectional view obtained by cutting along line ii in (a).

[0026] Figure 4 (a) to (c) are explanatory diagrams for explaining the operation of the sliding member in the blade of the first embodiment.

[0027] Figure 5 (a) to (e) are explanatory diagrams for explaining the operation of the blade according to the first embodiment.

[0028] Figure 6 (a) to (c) are explanatory diagrams for explaining the operation of the sliding member in the blade of the second embodiment.

[0029] Figure 7 (a) to (e) are explanatory diagrams for explaining the operation of the blade according to the second embodiment.

[0030] Figure 8 (a) is along Figure 1 A cross-sectional view obtained by cutting along the line ii-ii of (a), Figure 8 (b) is the state where the button is pressed along Figure 1 A cross-sectional view obtained by cutting along the line ii-ii in (a).

[0031] Fig. 9 This is an explanatory diagram for explaining the operation of the negative pressure generating cylinder.

[0032] Fig.10 It is a three-dimensional diagram of the trigger component.

[0033] Fig.11 (a) and (b) are explanatory diagrams for explaining skin incision during blood collection.

[0034] Fig.12 (a) is an explanatory diagram illustrating a state before the storage container is installed in the blood collection device of the present disclosure, Fig.12 (b) is an explanatory diagram illustrating a state after the storage container is attached to the blood collection device of the present disclosure.

[0035] Fig.13 This is an explanatory diagram for explaining a state where the blood sampling device of the present disclosure is attached to the skin.

[0036] Fig.14 This is an explanatory diagram for explaining a situation in which blood is collected using the blood collecting device of the present disclosure.

[0037] Fig.15 (a) is an explanatory diagram for explaining a state in which blood is accumulated in a storage container. Fig.15 (b) is an explanatory diagram illustrating a state in which the storage container has been removed from the blood collection device of the present disclosure. DETAILED DESCRIPTION

[0038] The "blood collection device" and "blood collection storage device" of the present disclosure are described in detail below. The description will be made with reference to the drawings as needed, but the contents of the drawings are only schematically and exemplarily shown for the understanding of the present disclosure, and the appearance and / or dimensional ratio may be different from the actual object.

[0039] The "up and down directions" and "left and right directions" used directly or indirectly in this specification correspond to the up and down directions and left and right directions in the figures, respectively. Unless otherwise specified, the same figure mark or symbol represents the same component or part or the same meaning. In addition, it can be understood that the vertical direction downward (i.e. the direction of gravity) is equivalent to the "downward direction", and the opposite direction is equivalent to the "upward direction". In addition, in this specification, terms indicating the relationship between elements (such as "parallel", "vertical", etc.) and terms indicating the shape of elements mean not only strict forms as the words say, but also essentially equivalent ranges, such as a range containing a difference of about a few percent. In addition, terms such as "setting", "configuration" and their derivative terms are not limited to direct forms unless otherwise specified, and may also be forms with other elements such as fixtures.

[0040] First, the "blood collection device" involved in the embodiment of the present disclosure is explained. The "blood collection device" mentioned in the present disclosure refers to a device for collecting blood from a subject in a broad sense, and refers to a device that also has a flow path for guiding the collected blood to a storage container in a narrow sense. Here, the storage container for storing the collected blood can be built into the blood collection device, or it can be configured to be external to the blood collection device. In other words, the blood collection device of the present disclosure that includes a storage container can also be referred to as a "blood collection storage device."

[0041] The blood collection device 1 showing one embodiment of the present disclosure includes a housing 20, a blade 30, a negative pressure generating cylinder 40, and a trigger member 50. Hereinafter, each structure will be described in detail with reference to the drawings.

[0042] - Description of the housing (see Figure 1 and Figure 2 )-

[0043] The housing 20 is a component that accommodates the various structures of the blood collection device 1. The housing shown in the figure can be rectangular in shape as a whole and can be made of resin material (such as plastic). The housing 20 can be composed of a first body 21 and a second body 22 that can be connected to each other. In other words, a single housing 20 can be composed of the first body 21 and the second body 22.

[0044] The first body 21 may include: a button 21b that is pressed by the subject when blood sampling starts, and a raised portion 21r for providing a space for accommodating the pressed button 21b. The button 21b may be rectangular with rounded corners in a plan view. Corresponding to the shape of the button 21b, the raised portion 21r may also be rectangular with rounded corners in a plan view.

[0045] The second body 22 may have an opposing surface that is opposed to the skin of the subject. An adhesive component 22a may be provided on the opposing surface. The adhesive component 22a may be any component as long as it can adhere to the skin of the subject, but is preferably a component that is low in allergy and gentle to the skin. By adhering the skin of the subject to the blood collection device using the adhesive component 22a, blood collection can be performed appropriately.

[0046] The opposite surface may be provided with an opening 22h for allowing the blade 30 to protrude from the housing 20. The blade 30 can protrude from the housing 20 through the opening 22h to incise the skin of the subject and collect blood.

[0047] A storage container T (see FIG. 2 ) for storing the collected blood may be provided on the side surface of the housing 20 formed by connecting the first body 21 and the second body 22 to each other. Fig.15 As a preferred form of the mounting portion, a flow path R (refer to Figure 2 (b)) is connected to the opening 23. The storage container T can be freely installed in the opening 23. For further optimization, a gasket G for making the storage container T close can be provided near the opening 23. The gasket G can be a resin material that can be elastically deformed. If the gasket G is provided near the opening 23, it is possible to prevent leakage of blood when the collected blood is stored in the storage container T.

[0048] The mounting portion (opening 23) is preferably arranged on the side of the housing 20 in the direction of gravity when the blood collection device 1 is adhered to the skin (see also the appropriate Fig.13 In other words, it is preferably the movable direction of the plunger 41 in the negative pressure generating cylinder 40 described later. By setting it as such an arrangement, the collected blood can be guided to the storage container T by its own weight.

[0049] The housing 20 may include at least a blade space BS for accommodating the blade 30 and a cylinder space SS for accommodating the negative pressure generating cylinder 40 (see Figure 2 (a), (b)).

[0050] · About the blade space for accommodating the blade

[0051] The central portion of the housing 20 may include a blade space BS. The blade space BS may communicate with the opening 22h of the opposing surface. Furthermore, the blade space BS may communicate with the mounting portion (opening 23).

[0052] As a preferred embodiment, the blade space BS can generate negative pressure by the negative pressure generating cylinder 40. That is, the blade space BS can function to introduce the collected blood by generating negative pressure. According to this embodiment, blood can be appropriately collected by generating negative pressure.

[0053] In order to appropriately generate negative pressure in the blade space BS, the blade space BS may be sealed by an airtight holding member 90. An example of the airtight holding member 90 may be a resin material that is elastically deformable. Figure 2 As shown in (a), an airtight holding member 90 may be disposed above the blade space BS. In addition, an airtight holding member 90 may also be disposed on the side surface of the blade space BS (for example, the side surface on the side where the trigger member 50 is disposed). In this way, by disposing the airtight holding member 90 around the blade space BS and sealing it via the airtight holding member 90, the airtightness of the blade space BS can be improved.

[0054] ・Regarding the cylinder space for housing the negative pressure generating cylinder

[0055] The cylinder space SS may be disposed on both sides of the blade space BS. In other words, the cylinder space SS may be in pairs. The cylinder space SS may be connected to the blade space BS on the side where the trigger member 50 is disposed. Therefore, if negative pressure is generated in the cylinder space SS by the operation of the negative pressure generating cylinder 40, negative pressure can be generated in the blade space BS through the connection (see, for example, FIG. 1 ). Fig. 9 ).

[0056] In order to accommodate the cylindrical negative pressure generating cylinder 40 described later, the cylinder space SS can be cylindrical corresponding to the cylindrical negative pressure generating cylinder 40. In addition, the cylinder space SS is preferably configured to extend in a direction perpendicular to the direction of gravity when the blood collection device 1 is adhered to the skin. In other words, the cylinder space SS is preferably extended in the direction of guiding the collected blood to the storage container T. In addition, if the cylinder space SS is determined from other viewpoints, the cylinder space SS is preferably extended in the force direction of the compression coil spring 60 that enables the plunger 41 in the negative pressure generating cylinder 40 to move, which is described later. If the cylinder space SS is designed in this way, the internal space of the housing 20 can be effectively utilized. In addition, in this specification, the shape of the negative pressure generating cylinder 40 is described as cylindrical, but it is not limited to this shape, for example, it can also be a columnar shape.

[0057] - Description of the blade (see Figures 3 to 7 )-

[0058] The blade 30 may include: a metal blade for cutting the skin, and a blade holding part made of resin for holding the blade. In addition, the blade holding part made of resin may be made of the same resin material as the housing 20, or may be made of a different material. The blade 30 can move in a manner of protruding from the housing 20 and cutting the skin in one direction when drawing blood. As a preferred form of the blade 30, it may be configured to engage with the movable body 70 (slider member 71 and guide member 72) described later. As a preferred form of the blade 30, it may include: an end 31 having an engaging protrusion engaged with the slider member 71 described later, and a shaft 32 that acts as a rotation axis of the blade 30 and engages with the guide member 72. In addition, the shaft 32 acts as the rotation center of the blade 30, but may be a structure that is displaced along the guide groove 72m of the guide member 72 described later. In addition, the displacement may specifically be an up-and-down displacement.

[0059] The end portion 31 may extend from the blade 30 (more specifically, the end portion of the blade holding portion) along the urging direction of the compression coil spring 60 used for the movement of the slider member 71 (see Figure 2 (a)). In addition, in order to make the blade 30 rotate, the shape of the end 31 can be set to a cylindrical shape. In addition, as long as the blade 30 can rotate smoothly, the shape of the end 31 is not limited to a cylindrical shape.

[0060] The shaft portion 32 can extend from the blade 30 (more specifically, the side surface of the blade holding portion) along the force direction of the compression coil spring 60 used for the movement of the slider member 71. In addition, the shape of the shaft portion 32 can protrude cylindrically from the side surface of the blade holding portion. In other words, it can be set as a projection of the shaft that becomes the shaft rotation. In addition, as long as the shaft rotation can be carried out smoothly, the shape of the shaft portion 32 is not limited to a cylindrical shape.

[0061] As a first embodiment of the blade 30, the direction of cutting the skin may be perpendicular to the direction of gravity when the blood collection device is bonded to the skin (hereinafter also referred to as "transverse cutting direction") (see Figure 4 and 5 ). In addition, as a second embodiment of the blade 30, the direction of cutting the skin may be the direction of gravity when the blood collection device is adhered to the skin (hereinafter also referred to as "longitudinal cutting direction") (refer to Figure 6 and 7 ). The blade of the first embodiment and the blade of the second embodiment are described in sequence.

[0062] ·Structure of the blade of the first embodiment

[0063] In order to enable the blade 30 to move, a pre-compressed compression coil spring 60 (see Figure 4(a) to (c)). That is, before blood collection, the compression coil spring 60 can be compressed toward the configuration side of the trigger member 50. In other words, the compression coil spring 60 can be compressed along the extension direction of the cylinder space SS. By releasing the compression of the compression coil spring 60, the blade 30 can be moved.

[0064] As a preferred form of the compression coil spring 60, the force application direction of the compression coil spring 60 may be perpendicular to the direction of the housing toward the skin. In other words, it may be parallel to the surface of the skin. By setting the force application direction of the compression coil spring 60 in this way, it is possible to prevent the force from acting in a direction perpendicular to the skin, thereby reducing the load on the skin.

[0065] The movement of the blade 30 can be brought about by the movable body 70, and the movable body 70 rotates the blade 30 by the force brought by the compression coil spring 60. In other words, the blade 30 can cut the skin in a predetermined direction (a transverse direction in the first embodiment) by rotating. In addition, the material of the movable body 70 can be a resin material (plastic as an example) like the housing 20, or it can be a material other than this.

[0066] The movable body 70 may include: a slider member 71 that holds the end portion 31 and can be moved by the force of the compression coil spring 60; and a guide member 72 that is formed with a guide groove 72m (see Figures 3 to 5 The slider member 71 and the guide member 72 can be moved respectively, and the blade 30 can cut the skin in a predetermined direction. The slider member 71 and the guide member 72 are described in detail below.

[0067] Slider parts (see Figure 4 )

[0068] The slider component 71 is a plate-like component that is roughly rectangular in shape when viewed from above, and may include: a receiving portion that receives the compression coil spring 60 at a corner; a groove 71m that is formed on a diagonal line to allow the end portion 31 to slide and move; and an engaging portion for the trigger component 50 (blade locking piece 52) to engage. In addition, regarding the "on the diagonal line" mentioned in this specification, in other words, it may be a direction that is angled relative to the extension direction of the negative pressure generating cylinder 40. And, regarding the "on the diagonal line" mentioned in this specification, in other words, it may be a direction that is angled relative to the compression direction of the compression coil spring 60 that enables the slider component 71 to move. In addition, as a specific form of the "angled direction", it is an angle that enables the end portion 31 to slide and move appropriately, and as an example, it may be an acute angle.

[0069] The groove 71m may be a through groove. In addition, as a preferred form of the groove 71m, an eave may be provided inside the groove 71m in order to contact the end portion 31 and make it slide. In other words, the end portion 31 may be held by the eave of the through groove while being able to slide.

[0070] ·Guide components (see Figure 5 )

[0071] The guide member 72 may be disposed below the slider member 71. Furthermore, the guide member 72 itself may be fixed in the blade space BS. In other words, the guide member 72 may be immovable in the blade space BS. The shaft portion 32 of the blade may be accommodated in the guide groove 72m.

[0072] As a specific groove shape of the guide groove 72m, the guide groove 72m can be provided in parallel with the direction of the housing 20 toward the skin. In other words, the guide groove 72m can be provided along the height direction of the housing 20. By forming the guide groove 72m in this way, the blade 30 can be moved toward the skin.

[0073] ·Description of the operation of the blade of the first embodiment

[0074] Reference Figure 4 and Figure 5 The operation of the blade 30 and the movable body 70 (the slider member 71 and the guide member 72 ) according to the first embodiment will be described.

[0075] Before blood sampling, the slider 71 is locked by the trigger member 50 (blade locking piece 52). In addition, the compression coil spring 60 is in a state of being compressed on the trigger member 50 side. In this state, if the locking of the trigger member 50 (blade locking piece 52) is released, the slider 71 slides in a direction away from the trigger member 50 (from the upper side to the lower side in the figure) due to the force of the compression coil spring 60. At this time, the end 31 moves from the right side of the figure to the left side along the groove 71m on the diagonal line in the example shown in the figure ( Figure 4 (a)~(c)).

[0076] On the other hand, the shaft portion 32 of the blade accommodated in the guide groove 72m can move along with the sliding movement of the slider member 71. Specifically, it moves up and down in the vertical direction. Figure 5 (a)), when the slider member 71 is locked by the trigger member 50 (blade locking piece 52), the blade 30 is accommodated in the housing 20. If the locking of the trigger member 50 (blade locking piece 52) is released, the shaft portion 32 of the blade moves downward along the guide groove 72m as the slider member 71 slides ( Figure 5(b)). Moreover, when the end portion 31 is located at the center of the groove 71m of the slider member 71 (that is, when the end portion 31 is located at the center in the direction perpendicular to the sliding direction in the blade space BS), as shown in FIG. Figure 5 As shown in (c), the shaft portion 32 of the blade 30 moves to the lowest position of the guide groove 72m, and the blade 30 protrudes the most from the housing 20. If the slider member 71 slides further, the shaft portion 32 of the blade moves upward along the guide groove 72m, and the blade 30 is accommodated in the housing 20 ( Figure 5 (d)). Moreover, when the compression coil spring 60 is fully extended, the sliding movement of the slider member 71 stops, and the cutting of the blade ends ( Figure 5 (e)). In addition, the blood collection device of the present disclosure may be a disposable device. That is, it may be a single-use type device.

[0077] Through the above-described operation, the blade 30 can be moved so as to be axially rotated relative to the shaft portion 32. The blade 30 is axially rotated, and the skin is incised in a predetermined direction (a transverse direction in the first embodiment).

[0078] ·Structure of the blade of the second embodiment

[0079] As a blade for cutting the skin in a direction different from that of the blade of the first embodiment, a blade Figure 6 and Figure 7 That is, the blade 30 can cut the skin in the longitudinal direction by rotating the axis. Hereinafter, the movable body 70 of the second embodiment will be described, but the description repeated with the first embodiment will be appropriately omitted.

[0080] Slider parts (see Figure 6 )

[0081] The slider member 71 is a plate-like member having a substantially rectangular shape in a plan view, and may include a housing portion that houses the compression coil spring 60 at a corner, a holding portion 71 h that holds the end portion 31 , and an engaging portion with which the trigger member 50 engages.

[0082] The retaining portion 71h can be set to a shape matching the shape of the end portion 31 so that the cylindrical end portion 31 can be fitted, and specifically, it can be in the form of a through hole. In addition, as a preferred form of the retaining portion 71h, an eave for retaining the end portion 31 can be provided inside the retaining portion 71h. In other words, the end portion 31b can be retained inside the retaining portion 71h by the eaves.

[0083] ·Guide components (see Figure 7 )

[0084] The guide member 72 may be disposed below the slider member 71. Furthermore, the guide member 72 itself may be fixed in the blade space BS. In other words, the guide member 72 may be immovable in the blade space BS. The shaft portion 32 of the blade may be accommodated in the guide groove 72m.

[0085] As a specific groove shape of the guide groove 72m, the guide groove 72m can be set to be parallel to the direction of the housing 20 toward the skin. In other words, the guide groove 72m can be set along the height direction of the housing. By forming the guide groove 72m in this way, the blade 30 can be moved toward the skin.

[0086] ·Description of the operation of the blade of the second embodiment

[0087] Reference Figure 6 and Figure 7 The operation of the blade 30 and the movable body 70 (the slider member 71 and the guide member 72 ) according to the second embodiment will be described.

[0088] Before blood collection, the slider component 71 is locked by the trigger component 50 (blade locking piece 52). In addition, the compression coil spring 60 is in a state of being compressed on the trigger component 50 side. In this state, if the locking of the trigger component 50 (blade locking piece 52) in the slider component 71 is released, the slider component 71 slides in a direction away from the trigger component 50 (from the upper side to the lower side in the figure) due to the force brought by the compression coil spring 60. At this time, the end portion 31 moves from the upper side of the figure to the lower side of the figure in the example shown in the figure as the slider component 71 slides (refer to Figure 6 More specifically, the end portion 31 can move in the same direction as the biasing direction of the compression coil spring 60 as the slider member 71 slides.

[0089] On the other hand, the shaft portion 32 of the blade accommodated in the guide groove 72m can move along with the sliding movement of the slider member 71. Specifically, it moves up and down in the vertical direction. Figure 7 (a)), when the slider member 71 is locked by the trigger member 50 (blade locking piece 52), the blade 30 is accommodated in the housing 20. If the locking of the trigger member 50 (blade locking piece 52) is released, the shaft portion 32 of the blade 30 moves downward along the guide groove 72m as the slider member 71 slides ( Figure 7 (b)). Moreover, when the end portion 31 is located at the center of the sliding direction in the blade space BS, as shown in FIG. Figure 7 As shown in (c), the shaft portion 32 of the blade 30 moves to the lowest position of the guide groove 72m, and the blade 30 protrudes the most from the housing 20. If the slider member 71 slides further, the shaft portion 32 of the blade 30 moves upward, and the blade 30 is accommodated in the housing 20 ( Figure 7 (d)). Moreover, when the compression coil spring 60 is fully extended, the sliding movement of the slider member 71 stops, and the cutting of the blade ends ( Figure 7 (e)). In addition, the blood collection device of the present disclosure may be a disposable device. That is, it may be a single-use type device.

[0090] Through the above-described operation, the blade 30 can be moved so as to be axially rotated relative to the shaft portion 32. The blade 30 is axially rotated, and the skin is incised in a predetermined direction (in the second embodiment, a longitudinal cutting direction).

[0091] - Description of negative pressure generating cylinder (refer to Figure 8 and 9 )-

[0092] The negative pressure generating cylinder 40 generates negative pressure in the housing 20 by the movement of the plunger 41 during blood collection. A preferred form of the negative pressure generating cylinder 40 may include: a cylindrical cylinder body 40a extending along the movable direction of the plunger 41; and a plunger 41 moving in the cylinder body 40a to generate a volume change.

[0093] The plunger 41 may include a disk portion 41a having a diameter substantially equal to the inner diameter of the cylinder body 40a, and an axial core 41b protruding from the disk portion 41a toward the trigger member 50. The disk portion 41a may be provided with a gasket G for being in close contact with the inner wall of the cylinder body 40a. The axial core 41b may include an engagement groove for engaging with the trigger member 50 (plunger engagement piece 53). In addition, a compression coil spring 60 may be mounted on the axial core 41b.

[0094] The movement of the negative pressure generating cylinder 40 can use a pre-compressed compression coil spring 60. That is, before blood sampling, the compression coil spring 60 can be compressed toward the configuration side of the trigger component 50. By releasing the compression of the compression coil spring 60, the plunger 41 can be moved, causing a volume change in the cylinder body 40a, and generating negative pressure.

[0095] As a preferred form of the compression coil spring 60, the force application direction of the compression coil spring 60 may be perpendicular to the direction of the housing toward the skin. In other words, it may be parallel to the surface of the skin. By setting the force application direction of the compression coil spring 60 in this way, it is possible to prevent the force from acting in a direction perpendicular to the skin, thereby reducing the load on the skin.

[0096] ·Description of the operation of the negative pressure generating cylinder

[0097] Before blood sampling, the plunger 41 is locked by the trigger member 50 (plunger locking piece 53) through the locking groove. In addition, the compression coil spring 60 is in a state of being compressed on the trigger member 50 side. In this state, if the locking of the trigger member 50 (plunger locking piece 53) is released, the plunger 41 can move in a direction away from the trigger member 50 by the force brought by the compression coil spring 60. More specifically, by the movement of the plunger 41, the volume of the plunger 41 side in the cylinder body 40a gradually increases, generating negative pressure.

[0098] Negative pressure can be generated in the blade space BS communicating with the cylinder space SS by generating negative pressure using the negative pressure generating cylinder 40. When the compression coil spring 60 is fully extended, the volume increase on the plunger 41 side of the cylinder body 40a ends, and generation of negative pressure ends.

[0099] - Description of trigger parts (refer to Fig.10 )-

[0100] The trigger component 50 is a component that is locked with the plunger 41 and the blade 30 before blood sampling to restrict the movement of the plunger 41 and the blade 30, and is released from the locking of the plunger and the blade during blood sampling to allow the movement of the blade 30 and the plunger 41. In addition, the material of the trigger component 50 can be the same resin material as the housing 20, or a different material.

[0101] As a preferred embodiment of the trigger member 50, it may include: an abutment portion 51 abutting against the button 21b of the housing; a blade locking piece 52 for locking the movement of the blade; and a plunger locking piece 53 for locking the movement of the plunger.

[0102] The contact portion 51 may be arranged to extend in the direction of the housing 20 toward the skin. The contact portion 51 may be configured to be pressed downward as the button 21b of the housing is pressed. In addition, a spring B ( ) having a repulsive force against the pressing of the button 21b of the housing may be arranged below the contact portion 51. Figure 2 (a)). In addition, considering that the blood collection device disclosed in the present invention is a disposable device, the button 21b may not be pressed even if a rebound caused by the spring B occurs. In other words, the button 21b may be accommodated in the raised portion 21r by pressing the button 21b.

[0103] The blade locking piece 52 may be provided to protrude from the side surface of the abutment portion 51 toward the blade 30. The blade locking piece 52 may be provided to be engaged with the engaging portion of the slider member 71. The blade locking piece 52 may be pressed downward as the button 21b of the housing is pressed, thereby releasing the engagement with the engaging portion of the slider member 71.

[0104] The plunger locking piece 53 may be arranged to extend toward each negative pressure generating cylinder 40. Specifically, each plunger locking piece 53 may be arranged on the same straight line. If each plunger locking piece 53 is determined from another perspective, the straight line connecting the plunger locking piece 53 may be perpendicular to the direction in which the blade locking piece 52 protrudes when viewed from above. If each plunger locking piece 53 is further determined from another perspective, the straight line connecting the plunger locking piece 53 may be perpendicular to the direction of the housing 20 toward the skin.

[0105] As a further preferred embodiment of the trigger member 50, the length L1 of the blade locking piece 52 ( Figure 3 (b)) can be longer than the length L2 of the plunger stopper 53 ( Figure 8 If such a structure is adopted, the locking of the blade 30 by the blade locking piece 52 is first released, and after the skin is cut by the blade 30, the locking of the plunger locking piece 53 by the plunger 41 is released. In other words, after the skin is cut by the blade 30, the blade space BS can be made into a negative pressure by the negative pressure generating cylinder 40, and the collected blood can be obtained into the housing 20.

[0106] Reference Fig.11 The reason why it is useful to first release the engagement of the blade 30 and then release the engagement of the negative pressure generating cylinder 40 as described above will be described.

[0107] In the case where the blade 30 is first released from the jamming and then the negative pressure generating cylinder 40 is released from the jamming, as shown in FIG. Fig.11 As shown in (a), when the skin S is cut by the blade 30, no negative pressure is generated in the blade space BS, thereby preventing the skin S from entering the blade space BS. When the skin S does not enter the blade space BS, the depth of the blade 30 entering the skin S can be maintained at a constant depth.

[0108] On the other hand, assuming that the negative pressure generating cylinder 40 is first released and then the blade 30 is released, Fig.11 As shown in (b), the blade 30 incises the skin S in a state where negative pressure is generated in the blade space BS by the negative pressure generating cylinder 40. That is, the skin S is incised in a state where the skin S enters the blade space BS. Here, the hardness of the skin S varies for each subject, so the amount of skin S that enters the blade space BS varies for each subject. In this way, the depth to which the blade 30 enters the skin S varies for each subject, and the incision of the skin by the blade 30 is unstable.

[0109] As described above, as a preferred embodiment of the trigger member 50, it is preferred that the length L1 ( Figure 3 (b)) is greater than the length L2 of the plunger locking piece 53 ( Figure 8(b)) is short, and the blade 30 is first released and then the negative pressure generating cylinder 40 is released.

[0110] - Instructions for using the blood collection device -

[0111] Reference Figure 12 to Figure 15 The method of using the blood collection device of the present invention is described. First, a storage container T ( Fig.12 (a)). The outer shape of the storage container T may be a shape that fits into the mounting portion (opening 23) of the housing.

[0112] After the storage container T is prepared, the storage container T is mounted on the mounting portion (opening 23) of the blood collection device 1 ( Fig.12 (b)). If a gasket G is provided at the mounting portion (opening 23), the blood collection device 1 and the storage container T can be mounted in close contact.

[0113] After the storage container T is mounted on the blood collection device 1, the blood collection device 1 is adhered to the skin ( Fig.13 ). If an adhesive component 22a is provided on the opposite surface of the blood collection device 1 to the subject's skin, the subject's skin and the blood collection device can be properly bonded. In addition, by bonding the blood collection device to the skin, the opening 22h connected to the blade space BS is blocked by the skin, so that the blade space BS can also be sealed.

[0114] When the blood collection device 1 is bonded to the skin S, it is preferred to bond the blood collection device 1 so that the storage container T mounted on the blood collection device 1 is on the side where gravity acts (vertically lower side). By bonding the blood collection device 1 to the skin S in this way, the blood collected by the blood collection device 1 can be guided to the storage container T by its own weight.

[0115] After the blood collection device 1 is adhered to the skin S, the button 21b provided on the housing 20 is pressed. The trigger member 50 is locked with the plunger 41 and the blade 30 at the time before the button 21b is pressed, so as to restrict the movement of both the plunger 41 and the blade 30. In this state, the button 21b is pressed, so that the trigger member 50 moves in the direction toward the skin S. Along with this, the locking of both the plunger 41 and the blade 30 is released, and the movement of the blade 30 and the plunger 41 is allowed.

[0116] More specifically, by releasing the locking of the blade 30 by the blade locking piece 52 of the trigger member 50, the compression coil spring 60 is released, and the slider member 71 slides. Then, as the slider member 71 slides, the shaft portion 32 of the blade can move along the guide groove 72m of the guide member 72, and the blade 30 cuts the skin. The operation of the blade 30 is described in detail in the above-mentioned "· Description of the operation of the blade of the first embodiment" and "· Description of the operation of the blade of the second embodiment".

[0117] In addition, by releasing the locking of the plunger locking piece 53 of the trigger member 50 on the plunger 41, the compression coil spring 60 is released, and the plunger 41 moves in the cylinder body 40a. In other words, a volume change occurs in the cylinder body 40a, and negative pressure is generated in the cylinder space SS and the blade space BS. The operation of the negative pressure generating cylinder 40 is described in detail in the above-mentioned "· Operation description of the negative pressure generating cylinder".

[0118] Here, as described in detail in the above-mentioned “-Description of Trigger Component-”, the trigger component 50 preferably first releases the locking of the blade 30 and then releases the locking of the negative pressure generating cylinder 40. By releasing the locking of the blade 30 and the locking of the negative pressure generating cylinder by the trigger component 50, the depth of the blade 30 entering the skin can be maintained at a constant depth.

[0119] The collected blood is stored in the storage container T (see Fig.14 As a preferred form of the flow path R, the flow path R is preferably inclined relative to the opposite surface of the housing 20 and the skin S. More specifically, it is preferred that the end of the flow path R on the storage container T side is inclined away from the opposite surface. By inclining the flow path R in this way, blood can be appropriately guided to the storage container T.

[0120] It is preferable that the blood ( Fig.15 As an example, the storage container T is preferably made of a transparent material. According to such a structure, the extent of blood stored in the storage container T can be visually determined.

[0121] After a sufficient amount of blood has been stored in the storage container T, the storage container T is removed from the blood collection device 1 ( Fig.15 (b)) and transfer the storage container to the inspection agency.

[0122] As described above, according to the blood collection device of the present disclosure, the trigger component 50 releases the blocking of both the plunger 41 and the blade 30 during blood collection, allowing the blade 30 and the plunger 41 to move, so there is no need to separately prepare components that serve as triggers for the movement of the blade 30 and the plunger 41. Therefore, blood collection can be appropriately performed with a simple structure.

[0123] In addition, the embodiments disclosed this time are illustrative in all aspects and are not the basis for restrictive interpretation. Therefore, the technical scope of the present disclosure is not interpreted solely by the above-mentioned embodiments, but is divided based on the records of the claims. In addition, the technical scope of the present disclosure includes all changes within the meaning and scope equivalent to the claims. For example, the shape and / or color of the shell in the blood collection device or the blood collection storage device can also be changed according to the purpose of blood collection and / or the customer. As an example, the shape of the shell can also be changed to a rectangular shape and / or a circular shape according to the purpose of blood collection and / or the customer, and / or the color of the button of the shell can be changed according to the purpose of blood collection and / or the customer.

[0124] Furthermore, the blood sampling device and blood collection storage device disclosed in the present invention may include the following preferred embodiments.

[0125] First Form:

[0126] A blood sampling device is a blood sampling device having a flow path for guiding collected blood to a storage container, wherein the device comprises:

[0127] case;

[0128] a blade capable of moving in a manner of protruding from the housing and cutting the skin in one direction;

[0129] a negative pressure generating cylinder for generating negative pressure in the housing by movement of a plunger; and

[0130] The trigger component is housed in the housing and operates when blood sampling begins.

[0131] The trigger components are composed of:

[0132] The plunger and the blade are locked to limit the movement of the plunger and the blade.

[0133] When the locking of both the plunger and the blade is released, the movement of the blade and the plunger is permitted.

[0134] Second Form:

[0135] A blood sampling device, in the first form, wherein the plunger and / or the blade are moved using a pre-compressed coil spring.

[0136] Third Form:

[0137] A blood collection device, in the second form, the movement of the blade is achieved by a movable body, and the movable body causes the blade to rotate axially by the force brought by the compression coil spring.

[0138] Fourth Form:

[0139] A blood sampling device, in the third aspect,

[0140] The movable body has:

[0141] a slider member holding one end of the blade and capable of being moved by the biasing force of the coil spring; and

[0142] The guide member is formed with a guide groove for accommodating a shaft portion for axially rotating the blade.

[0143] Fifth Form:

[0144] A blood collection device, in the fourth form, wherein the guide groove of the guide component is arranged to be parallel to the direction of the shell toward the skin.

[0145] Sixth Form:

[0146] A blood sampling device, in the fourth aspect or the fifth aspect, wherein the shaft portion is movable along the guide groove of the guide member.

[0147] Seventh Form:

[0148] A blood collection device, in any one of the fourth to sixth forms, wherein the slider member has a groove formed on a diagonal line,

[0149] One end portion of the blade is movable along the diagonal groove.

[0150] Eighth Form:

[0151] A blood collection device, in any one of the fourth to seventh forms, wherein the direction in which the skin is cut by the blade is perpendicular to the direction of gravity when the blood collection device is adhered to the skin.

[0152] Ninth Form:

[0153] In the fourth aspect, a blood sampling device is provided, wherein one end portion of the blade is movable in the same direction as the biasing direction of the coil spring along with the movement of the slider member.

[0154] Tenth Form:

[0155] A blood collection device, in the above-mentioned ninth form, the direction in which the skin is cut by the above-mentioned blade is the direction of gravity when the above-mentioned blood collection device is adhered to the skin.

[0156] Eleventh Form:

[0157] In a blood sampling device according to any one of the second to tenth aspects, a biasing direction of the coil spring used for moving the plunger and / or the blade is perpendicular to a direction of the housing toward the skin.

[0158] Twelfth Form:

[0159] In any one of the first to eleventh aspects, a blood sampling device is provided with an adhesive member on a surface of the housing facing the skin.

[0160] Thirteenth Form:

[0161] In the blood sampling device according to any one of the first to twelfth aspects, the trigger member releases the locking of the plunger after releasing the locking of the blade.

[0162] Fourteenth Form:

[0163] A blood sampling device, in the thirteenth aspect, wherein the trigger component comprises:

[0164] A blade locking piece is used to lock the movement of the blade; and

[0165] The plunger stopper stops the movement of the plunger.

[0166] The length of the blade locking piece is shorter than the length of the plunger locking piece.

[0167] Fifteenth Form:

[0168] In a blood sampling device according to any one of the first to fourteenth aspects, a negative pressure is generated in the space in the housing that accommodates the blade by the negative pressure generating cylinder.

[0169] Sixteenth Form:

[0170] A blood sampling device, in any one of the first to fifteenth aspects, wherein at least the periphery of the space for accommodating the blade is sealed by an airtight holding member.

[0171] Seventeenth Form:

[0172] A blood sampling device, in any one of the first to sixteenth aspects, wherein the negative pressure generating cylinder is arranged on both sides of a space for accommodating the blade.

[0173] Eighteenth Form:

[0174] A blood sampling device according to any one of the first to seventeenth aspects, wherein a mounting portion for mounting the storage container is provided on the side of the housing in the direction of gravity when the blood sampling device is adhered to the skin.

[0175] Nineteenth Form:

[0176] A blood sampling device, in the above-mentioned eighteenth form, wherein the flow path connected to the above-mentioned mounting portion is inclined relative to the surface of the above-mentioned shell facing the above-mentioned skin.

[0177] Twentieth Form:

[0178] A blood sampling and storage device, comprising:

[0179] Any one of the blood collection devices of the first to nineteenth aspects; and

[0180] The storage container is located on the gravity direction side when the blood collection device is adhered to the skin, and stores the blood collected by the blood collection device.

[0181] Industrial Applicability

[0182] The blood sampling device and blood sampling storage device disclosed herein are used to collect blood from a subject or store the collected blood.

[0183] Description of Reference Numerals

[0184] 1…Blood collection device; 20…Casing; 21…First body; 21b…Button; 21r…Raised portion; 22…Second body; 22a…Adhesive component; 22h…Opening of second body; 23…Mounting portion (opening); 30…Blade; 31…End portion; 32…Axle portion; 40…Negative pressure generating cylinder; 40a…Cylinder body; 41…Plunger; 41a…Disc portion; 41b…Axle core; 50…Trigger component; 51…Abutment portion; 52…Blade retaining plate; 53…Plunger retaining plate; 60…Compression coil spring; 70…Movable body; 71…Slider component; 71m…Groove; 71h…Retaining portion; 72…Guide component; 72m…Guide groove; 80…Adhesive component; 90…Airtight retaining component; B…Spring; G…Gasket; BS…Blade space; SS…Cylinder space; S…Skin; T…Storage container; R…Flow path.

Claims

1. A blood collection device having a flow path for guiding collected blood to a storage container, characterized in that: have: case; a blade capable of moving in a manner of protruding from the housing and cutting the skin in one direction; a negative pressure generating cylinder for generating negative pressure in the housing through movement of a plunger; as well as The trigger component is housed in the housing and operates when blood sampling begins. The trigger component is composed of: The plunger and the blade are locked to limit the movement of the plunger and the blade. When the locking of both the plunger and the blade is released, the movement of the blade and the plunger is permitted.

2. The blood collection device according to claim 1, characterized in that: The plunger and / or the blade are moved using a pre-compressed compression coil spring.

3. The blood collection device according to claim 2, characterized in that: The movement of the blade is achieved by a movable body, and the movable body causes the blade to perform axial rotation by the force brought by the compression coil spring.

4. The blood collection device according to claim 3, characterized in that: The movable body comprises: a slider member, holding one end portion of the blade, capable of being moved by the urging force of the compression coil spring; and The guide member is formed with a guide groove for accommodating a shaft portion for axially rotating the blade.

5. The blood collection device according to claim 4, characterized in that: The guide groove of the guide component is arranged to be parallel to a direction of the housing toward the skin.

6. The blood collection device according to claim 4 or 5, characterized in that: The shaft portion is movable along the guide groove of the guide member.

7. The blood sampling device according to any one of claims 4 to 6, characterized in that: The slider member is formed with a groove diagonally. One end of the blade is movable along the diagonal groove.

8. The blood sampling device according to any one of claims 4 to 7, characterized in that: The direction in which the skin is cut by the blade is perpendicular to the direction of gravity when the blood collection device is adhered to the skin.

9. The blood collection device according to claim 4, characterized in that: The slider member is configured so that one end portion of the blade can move in the same direction as the biasing direction of the compression coil spring.

10. The blood collection device according to claim 9, characterized in that: The direction in which the skin is cut by the blade is the direction of gravity when the blood collection device is adhered to the skin.

11. The blood sampling device according to any one of claims 2 to 10, characterized in that: The urging direction of the compression coil spring used for moving the plunger and / or the blade is perpendicular to the direction of the housing toward the skin.

12. The blood sampling device according to any one of claims 1 to 11, characterized in that: An adhesive member is provided on a surface of the housing that faces the skin.

13. The blood sampling device according to any one of claims 1 to 12, characterized in that: The trigger member releases the locking of the plunger after releasing the locking of the blade.

14. The blood collection device according to claim 13, characterized in that: The trigger component has: A blade locking piece is used to lock the movement of the blade; and The plunger stopper stops the movement of the plunger. The length of the blade locking piece is shorter than the length of the plunger locking piece.

15. The blood sampling device according to any one of claims 1 to 14, characterized in that: In the housing, a negative pressure is generated in the space that accommodates the blade by the negative pressure generating cylinder.

16. The blood sampling device according to any one of claims 1 to 15, characterized in that: At least the periphery of the space for accommodating the blade is sealed by an airtight holding member.

17. The blood sampling device according to any one of claims 1 to 16, characterized in that: The negative pressure generating cylinders are arranged on both sides of the space for accommodating the blade.

18. The blood sampling device according to any one of claims 1 to 17, characterized in that: The housing includes a mounting portion on which the storage container is mounted on a side in the direction of gravity when the blood sampling device is adhered to the skin.

19. The blood collection device according to claim 18, characterized in that: The flow path communicating with the mounting portion is inclined relative to a surface of the housing facing the skin.

20. A blood collection and storage device, characterized in that: have: The blood sampling device according to any one of claims 1 to 19; and The storage container is located on the gravity direction side when the blood collection device is adhered to the skin, and stores the blood collected by the blood collection device.

Images