Blood collection device and blood collection and storage device

Abstract

Provided are a blood collection device and a blood collection and storage device with which it is possible to collect blood in a suitable manner using a simple structure. A blood collection device (1) according to the present disclosure comprises a flow path (R) for guiding collected blood to a storage container (T), wherein the blood collection device (1) further comprises a housing (20), a blade (30) that can move so as to project from the housing (20) and cut through the skin in one direction, a negative-pressure-producing cylinder (40) for generating a negative pressure in the housing (20) through the movability of a plunger (41), and a trigger member (50) that is housed in the housing (20) and that operates when blood collection is started. The trigger member (50) is locked to the plunger (41) and the blade (30) so as to restrict movability of the plunger (41) and the blade (30), and once the plunger (41) and the blade (30) have been unlocked, movability of the blade (30) and the plunger (41) are allowed.

Description

Blood collection device and blood collection and storage device

[0001] The present disclosure relates to blood collection devices and blood collection and reservoir devices.

[0002] Blood sampling devices for sampling body fluids such as blood from a subject are disclosed in Patent Documents 1 to 3.

[0003] Special table 2012-519052 publication Special table 2018-534541 publication Special table 2019-505282 publication

[0004] This type of blood collection device requires that the collected blood be taken into the device. Specifically, the blood is taken into the device by creating a negative pressure inside the blood collection device while the device is in close contact with the subject's skin.

[0005] One method for creating a negative pressure inside a 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 involves the hassle of having to prepare an internal pressure lower than atmospheric pressure in advance.

[0006] As another method for creating a negative pressure inside a blood collection device, Patent Documents 2 and 3 describe a method for creating a vacuum by "a volume change when a plunger moves." Specifically, Patent Document 2 discloses that a piercing element pierces the skin, and a plunger is used to create a vacuum when the piercing element is withdrawn. Patent Document 3 also discloses that an actuating mechanism is deployed to extend a lancet that pierces the skin, and then a retraction action creates a vacuum inside the sealed portion.

[0007] However, the blood collection devices disclosed in Patent Documents 2 and 3 required separate components to be prepared as triggers for the "action of perforating the skin" and the "action of generating a vacuum." As a result, the blood collection devices disclosed in Patent Documents 2 and 3 required a large number of components, leaving room for improvement in terms of manufacturing cost and / or manufacturing efficiency.

[0008] Therefore, an object of the present disclosure is to provide a blood collection device and a blood collection and storage device that can perform blood collection more appropriately with a simple structure.

[0009] In order to solve the above problems, the blood collection device of the present disclosure is a blood collection device having a flow path that guides collected blood to a storage container, and comprises: a housing; a blade that protrudes from the housing and moves to cut the skin in one direction; a negative pressure generating cylinder that generates negative pressure within the housing by moving the plunger; and a trigger member that is housed in the housing and is activated when blood collection begins, wherein the trigger member engages with the plunger and the blade so as to restrict the movement of both the plunger and the blade, and when the engagement of both the plunger and the blade is released, the blade and the plunger are allowed to move.

[0010] The blood collection and storage device of the present disclosure comprises the above-mentioned blood collection device and a storage container that is positioned on the gravity side when the blood collection device is attached to the skin and that stores the blood collected by the blood collection device.

[0011] According to the present disclosure, it is possible to provide a blood collection device and a blood collection and storage device that can more appropriately collect blood with a simple structure.

[0012] FIG. 1(a) is a perspective view of the blood collection device of the present disclosure as viewed from above, and FIG. 1(b) is a perspective view of the blood collection device of the present disclosure as viewed from below. FIG. 2(a) is a perspective view of the interior of the blood collection device of the present disclosure, and FIG. 2(b) is a cross-sectional view taken along line b-b in FIG. 2(a). FIG. 3(a) is a cross-sectional view taken along line i-i in FIG. 1(a), and FIG. 3(b) is a cross-sectional view taken along line i-i in FIG. 1(a) with the button pressed. FIGS. 4(a) to 4(c) are explanatory diagrams illustrating the operation of the sliding member of the blade of the first embodiment. FIGS. 5(a) to 5(e) are explanatory diagrams illustrating the operation of the blade of the first embodiment. FIGS. 6(a) to 6(c) are explanatory diagrams illustrating the operation of the sliding member of the blade of the second embodiment. FIGS. 7(a) to 7(e) are explanatory diagrams illustrating the operation of the blade of the second embodiment. FIG. 8(a) is a cross-sectional view taken along line ii-ii in FIG. 1(a), and FIG. 8(b) is a cross-sectional view taken along line ii-ii in FIG. 1(a) with the button pressed. FIG. 9 is an explanatory diagram illustrating the operation of the negative pressure generating cylinder. FIG. 10 is a perspective view of the trigger member. FIGS. 11(a) and 11(b) are explanatory diagrams illustrating the incision of the skin during blood collection. FIG. 12(a) is an explanatory diagram illustrating the state before a storage container is attached to the blood collection device of the present disclosure, and FIG. 12(b) is an explanatory diagram illustrating the state after the storage container is attached to the blood collection device of the present disclosure. FIG. 13 is an explanatory diagram illustrating the state in which the blood collection device of the present disclosure is attached to the skin. FIG. 14 is an explanatory diagram illustrating blood collection using the blood collection device of the present disclosure. FIG. 15(a) is an explanatory diagram illustrating the state in which blood has accumulated in the storage container, and FIG. 15(b) is an explanatory diagram illustrating the state in which the storage container has been removed from the blood collection device of the present disclosure.

[0013] The "blood collection device" and "blood collection and storage device" of the present disclosure will be described in detail below. While the description will be made with reference to drawings as necessary, the contents shown in the drawings are merely shown schematically and exemplarily to facilitate understanding of the present disclosure, and the appearance and / or dimensional ratios may differ from the actual product.

[0014] The terms "vertical direction" and "horizontal direction" used directly or indirectly in this specification correspond to the vertical direction and horizontal direction in the drawings, respectively. Unless otherwise specified, the same reference numerals or symbols indicate the same components or parts or the same meaning. Furthermore, the vertical downward direction (i.e., the direction in which gravity acts) can be considered to correspond to the "downward direction," and the opposite direction can be considered to correspond to the "upward direction." Furthermore, in this specification, terms indicating the relationship between elements (e.g., "parallel," "vertical," etc.) and terms indicating the shape of elements do not only refer to the strict literal form, but also to a range of substantial equivalence, for example, a range including a difference of a few percent. Furthermore, terms such as "provided," "disposed," and their derivatives are not limited to direct forms, and may also refer to forms involving other elements, such as intervening objects, unless otherwise explicitly stated.

[0015] First, a "blood collection device" according to an embodiment of the present disclosure will be described. In the present disclosure, the term "blood collection device" refers, in a broad sense, to a device for collecting blood from a subject, and in a narrow sense, to a device that also includes a flow path for guiding the collected blood to a storage container. Here, the storage container for storing the collected blood may be built into the blood collection device or may be externally attachable to the blood collection device. In other words, the blood collection device of the present disclosure may be referred to as a "blood collection and storage device" as an embodiment that includes a storage container.

[0016] A blood collection device 1 representing one embodiment of the present disclosure includes a housing 20, a blade 30, a negative pressure generating cylinder 40, and a trigger member 50. Each component will be described in detail below with reference to the drawings.

[0017] - Description of the Housing (See Figures 1 and 2 as appropriate) - The housing 20 houses each component of the blood collection device 1. The housing in the illustrated example may have an overall rectangular shape and may be made of a resin material (e.g., plastic). The housing 20 may be composed of, for example, a first main body 21 and a second main body 22 that are connectable to each other. In other words, the first main body 21 and the second main body 22 may form a single housing 20.

[0018] The first main body 21 may include a button 21b that the subject presses to start blood collection, and a raised portion 21r for providing a space to accommodate the pressed button 21b. The button 21b may have a rectangular shape with rounded corners in a plan view. Corresponding to the shape of the button 21b, the raised portion 21r may also have a rectangular shape with rounded corners in a plan view.

[0019] The second body 22 may have a surface that faces the subject's skin. An adhesive member 22a may be provided on the facing surface. The adhesive member 22a may be any material that can adhere to the subject's skin, but is preferably hypoallergenic and gentle on the skin. By adhering the blood collection device to the subject's skin with the adhesive member 22a, blood collection can be performed appropriately.

[0020] The opposing surface may have an opening 22h that allows the blade 30 to protrude from the housing 20. The opening 22h allows the blade 30 to protrude from the housing 20, cut the skin of the subject, and collect blood.

[0021] A mounting portion for mounting a storage container T (see FIG. 15) for storing collected blood may be provided on the side of the housing 20, which is formed by connecting the first body 21 and the second body 22 to each other. A preferred embodiment of the mounting portion is an opening 23 that communicates with a flow path R (see FIG. 2(b)) through which the collected blood is guided. The storage container T may be freely attached to the opening 23. More preferably, a gasket G for tightly sealing the storage container T may be provided near the opening 23. The gasket G may be made of an elastically deformable resin material. Providing the gasket G near the opening 23 prevents blood leakage when the collected blood is stored in the storage container T.

[0022] The attachment portion (opening 23) is preferably positioned on the side of the housing 20 facing the direction of gravity when the blood collection device 1 is attached to the skin (see also FIG. 13 as appropriate). In other words, it is preferably positioned in the direction in which the plunger 41 of the negative pressure generating cylinder 40, which will be described later, can move. By positioning it in this way, the collected blood can be guided into the storage container T by its own weight.

[0023] The housing 20 may have at least a blade space BS for accommodating the blades 30 and a cylinder space SS for accommodating the negative pressure generating cylinder 40 inside (see FIGS. 2( a ) and 2 ( b )).

[0024] Regarding the blade space BS that houses the blades, the blade space BS may be provided in the central portion of the housing 20. The blade space BS may also communicate with the opening 22h on the opposing surface described above. Furthermore, the blade space BS may also communicate with the attachment portion (opening 23) described above.

[0025] In a preferred embodiment, negative pressure may be generated in the blade space BS by the negative pressure generating cylinder 40. In other words, the blade space BS may act to draw in the collected blood by generating negative pressure. According to this embodiment, the blood can be collected appropriately by generating negative pressure.

[0026] Furthermore, in order to appropriately generate negative pressure in the blade space BS, the periphery of the blade space BS may be sealed by an airtight seal member 90. One example of the airtight seal member 90 is an elastically deformable resin material. As one example, the airtight seal member 90 may be disposed above the blade space BS, as shown in FIG. 2( a). Furthermore, the airtight seal member 90 may also be disposed on a side surface of the blade space BS (for example, the side surface on which the trigger member 50 is disposed). In this way, by disposing the airtight seal member 90 around the periphery of the blade space BS and sealing it via the airtight seal member 90, the airtightness of the blade space BS can be improved.

[0027] Regarding the cylinder space SS accommodating the negative pressure generating cylinder, the cylinder spaces SS may be disposed on both sides of the blade space BS. In other words, the cylinder spaces SS may be paired. The cylinder space SS may be in communication with the blade space BS on the side where the trigger member 50 is disposed. Therefore, when 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 due to this communication (see FIG. 9 as appropriate).

[0028] The cylinder space SS may be cylindrical in shape to accommodate the cylindrical negative pressure generating cylinder 40 described below. Furthermore, the cylinder space SS preferably extends 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 preferably extends in the direction in which the collected blood is guided to the storage container T. From another perspective, the cylinder space SS preferably extends in the biasing direction of the compression coil spring 60 that moves the plunger 41 of the negative pressure generating cylinder 40 described below. Designing the cylinder space SS in this manner allows for effective use of the internal space of the housing 20. Although the shape of the negative pressure generating cylinder 40 has been described herein as cylindrical, the shape is not limited to this and may be, for example, columnar.

[0029] -Explanation of the Blade (See Figures 3 to 7 as Appropriate)- The blade 30 may include a metal blade that cuts the skin and a resin blade holder that holds the blade. The resin blade holder may be made of the same resin material as the housing 20, or a different material. The blade 30 protrudes from the housing 20 during blood collection and moves to cut the skin in one direction. A preferred embodiment of the blade 30 may be configured to engage with a movable body 70 (a slider member 71 and a guide member 72) described below. A preferred embodiment of the blade 30 may include an end 31 having an engaging protrusion that engages with the slider member 71 described below, and a shaft 32 that acts as the rotation axis of the blade 30 and engages with the guide member 72. The shaft 32 acts as the center of rotation of the blade 30, but may also be configured to displace along a guide groove 72m of the guide member 72 described below. Specifically, this displacement may be vertical displacement.

[0030] The end 31 may extend from the blade 30 (more specifically, from the end of the blade holding portion) along the biasing direction of the compression coil spring 60 used to move the slider member 71 (see FIG. 2( a)). The shape of the end 31 may be cylindrical in order to rotate the blade 30. However, the shape of the end 31 is not limited to a cylindrical shape as long as it allows the blade 30 to rotate smoothly.

[0031] The shaft portion 32 may extend from the blade 30 (more specifically, from the side surface of the blade holding portion) along the biasing direction of the compression coil spring 60 used to move the slider member 71. The shaft portion 32 may also be cylindrical and protrude from the side surface of the blade holding portion. In other words, it may be a protrusion that serves as an axis of axial rotation. The shape of the shaft portion 32 is not limited to a cylindrical shape as long as it allows smooth axial rotation.

[0032] In a first embodiment of the blade 30, the direction in which the skin is cut may be perpendicular to the direction of gravity when the blood collection device is adhered to the skin (hereinafter also referred to as the "transverse cutting direction") (see Figures 4 and 5). In a second embodiment of the blade 30, the direction in which the skin is cut may be the direction of gravity when the blood collection device is adhered to the skin (hereinafter also referred to as the "longitudinal cutting direction") (see Figures 6 and 7). The blade of the first embodiment and the blade of the second embodiment will be described in order.

[0033] Configuration of the Blade in the First Embodiment A pre-compressed compression coil spring 60 may be used to move the blade 30 (see FIGS. 4( a) to 4(c)). That is, before blood collection, the compression coil spring 60 may be compressed toward the side where the trigger member 50 is located. In other words, the compression coil spring 60 may be compressed along the extension direction of the cylinder space SS. The blade 30 can be moved by releasing the compression of the compression coil spring 60.

[0034] In a preferred embodiment of the compression coil spring 60, the biasing direction of the compression coil spring 60 may be perpendicular to the direction in which the housing faces the skin. In other words, the biasing direction of the compression coil spring 60 may be parallel to the surface of the skin. By using such a biasing direction of the compression coil spring 60, it is possible to prevent the biasing force from acting in a direction perpendicular to the skin, thereby reducing the load on the skin.

[0035] The movement of the blade 30 may be brought about by a movable body 70 that rotates the blade 30 by the biasing force brought about by the compression coil spring 60. In other words, the rotation of the blade 30 may cut the skin in a predetermined direction (in the first embodiment, the transverse direction). The material of the movable body 70 may be a resin material (plastic, for example) like the housing 20, or may be other materials.

[0036] The movable body 70 may include a slider member 71 that holds the end portion 31 and is movable by the biasing force of the compression coil spring 60, and a guide member 72 that has a guide groove 72m formed therein and that accommodates the shaft portion 32 that rotates the blade about its axis (see FIGS. 3 to 5). The slider member 71 and the guide member 72 may each be moved, causing the blade 30 to cut the skin in a predetermined direction. The slider member 71 and the guide member 72 will be described in detail below.

[0037] Slider Member (See FIG. 4) The slider member 71 is a plate-like member that is substantially rectangular in plan view and may include a housing portion at one corner that houses the compression coil spring 60, a diagonally formed groove 71m for sliding the end portion 31, and an engagement portion with which the trigger member 50 (blade locking piece 52) engages. Note that "diagonally" as used herein may be rephrased as a direction that forms an angle with respect to the extension direction of the negative pressure generating cylinder 40. Note that "diagonally" as used herein may be rephrased as a direction that forms an angle with respect to the compression direction of the compression coil spring 60 that moves the slider member 71. A specific aspect of the "angled direction" is an angle that allows the end portion 31 to slide appropriately, and may be, for example, an acute angle.

[0038] The groove 71m may be in the form of a through groove. Furthermore, as a preferred embodiment of the groove 71m, an eave may be provided inside the groove 71m to contact the end portion 31 and allow it to slide. In other words, the end portion 31 may be able to slide while being held by the eave of the through groove.

[0039] Guide Member (See FIG. 5) The guide member 72 may be disposed below the slider member 71. The guide member 72 itself may be fixed within the blade space BS. In other words, the guide member 72 does not need to move within the blade space BS. The guide groove 72m may accommodate the shaft portion 32 of the blade.

[0040] As a specific groove shape of the guide groove 72m, the guide groove 72m may be provided parallel to the direction in which the housing 20 faces the skin. In other words, the guide groove 72m may be provided along the height direction of the housing 20. By forming the guide groove 72m in this manner, the blade 30 can be moved toward the skin.

[0041] Description of Operation of Blade in First Embodiment The operation of the blade 30 and the movable body 70 (slider member 71 and guide member 72) in the first embodiment will be described with reference to FIGS. 4 and 5. FIG.

[0042] Before blood collection, the slider member 71 is locked by the trigger member 50 (blade locking piece 52). The compression coil spring 60 is compressed on the trigger member 50 side. In this state, when the trigger member 50 (blade locking piece 52) is released, the slider member 71 slides away from the trigger member 50 (from the top to the bottom in the drawing) due to the biasing force of the compression coil spring 60. At that time, the end 31 moves from the right side to the left side in the drawing along the diagonal groove 71m (FIGS. 4(a) to 4(c)).

[0043] Meanwhile, the blade shaft 32 housed in the guide groove 72m moves in conjunction with the sliding movement of the slider member 71. Specifically, it moves up and down in the vertical direction. In the illustrated example ( FIG. 5( a) ), when the slider member 71 is engaged with the trigger member 50 (blade locking piece 52), the blade 30 is housed within the housing 20. When the trigger member 50 (blade locking piece 52) is released from engagement, the blade shaft 32 moves downward along the guide groove 72m in conjunction with the sliding movement of the slider member 71 ( FIG. 5( b) ). When the end 31 is positioned in the center of the groove 71m of the slider member 71 (i.e., when the end 31 is positioned in the center of the blade space BS in the direction perpendicular to the sliding direction), as shown in FIG. 5( c) , the shaft 32 of the blade 30 moves to the lowest position in the guide groove 72m, and the blade 30 protrudes most from the housing 20. As the slider member 71 continues to slide, the blade shaft 32 moves upward along the guide groove 72m, and the blade 30 is housed within the housing 20 (FIG. 5(d)). When the compression coil spring 60 is fully extended, the slider member 71 stops sliding, and the blade finishes cutting (FIG. 5(e)). The blood collection device of the present disclosure may be a device that can be used once. In other words, it may be a single-use device.

[0044] By the above operation, the blade 30 moves so as to rotate about its axis relative to the shaft portion 32, and as the blade 30 rotates about its axis, the skin is cut in a predetermined direction (in the first embodiment, a crosswise direction).

[0045] Configuration of the Blade of the Second Embodiment The blade shown in Figures 6 and 7 may be used as a blade that cuts the skin in a direction different from that of the blade of the first embodiment. In other words, the blade 30 may cut the skin in a longitudinal direction by rotating around its axis. The movable body 70 of the second embodiment will be described below, but descriptions that overlap with those of the first embodiment will be omitted as appropriate.

[0046] Slider member (see FIG. 6) The slider member 71 is a plate-like member that is approximately rectangular in plan view, and may include a housing portion that houses the compression coil spring 60 at a corner, a holding portion 71h that holds the end portion 31, and an engaging portion with which the trigger member 50 engages.

[0047] The retaining portion 71h may have a shape that matches the shape of the end portion 31 so that the cylindrical end portion 31 fits therein, and specifically may be in the form of a through hole. Furthermore, as a preferred embodiment of the retaining portion 71h, an eave may be provided inside the retaining portion 71h to hold the end portion 31b. In other words, the end portion 31b may be held inside the retaining portion 71h by the eave.

[0048] Guide Member (See FIG. 7) The guide member 72 may be disposed below the slider member 71. The guide member 72 itself may be fixed within the blade space BS. In other words, the guide member 72 does not need to move within the blade space BS. The guide groove 72m may accommodate the shaft portion 32 of the blade.

[0049] As a specific groove shape of the guide groove 72m, the guide groove 72m may be provided parallel to the direction in which the housing 20 faces the skin. In other words, the guide groove 72m may be provided along the height direction of the housing. By forming the guide groove 72m in this manner, the blade 30 can be moved toward the skin.

[0050] Description of Operation of Blade in Second Embodiment The operation of the blade 30 and the movable body 70 (slider member 71 and guide member 72) in the second embodiment will be described with reference to FIGS. 6 and 7. FIG.

[0051] Before blood collection, the slider member 71 is locked by the trigger member 50 (blade locking piece 52). The compression coil spring 60 is compressed on the trigger member 50 side. When the trigger member 50 (blade locking piece 52) is released from the slider member 71 in this state, the slider member 71 slides away from the trigger member 50 (from top to bottom in the drawing) due to the biasing force of the compression coil spring 60. At this time, the end portion 31 moves from top to bottom in the drawing in conjunction with the sliding of the slider member 71 (see FIGS. 6( a) to 6(c)). More specifically, the end portion 31 moves in the same direction as the biasing direction of the compression coil spring 60 in conjunction with the sliding of the slider member 71.

[0052] Meanwhile, the shaft 32 of the blade housed in the guide groove 72m moves in conjunction with the sliding movement of the slider member 71. Specifically, it moves up and down in the vertical direction. In the illustrated example ( FIG. 7( a) ), when the slider member 71 is engaged with the trigger member 50 (blade locking piece 52), the blade 30 is housed within the housing 20. When the trigger member 50 (blade locking piece 52) is released from engagement, the shaft 32 of the blade 30 moves downward in the drawing along the guide groove 72m in conjunction with the sliding movement of the slider member 71 ( FIG. 7( b) ). Then, when the end 31 is positioned at the center of the blade space BS in the sliding direction, the shaft 32 of the blade 30 moves to the lowest position in the guide groove 72m, as shown in FIG. 7( c) , and the blade 30 protrudes most from the housing 20. As the sliding movement of slider member 71 continues, shaft portion 32 of blade 30 moves upward, and blade 30 is housed within housing 20 (FIG. 7(d)). When compression coil spring 60 is fully extended, sliding movement of slider member 71 stops, and the blade finishes cutting (FIG. 7(e)). The blood collection device of the present disclosure may be a device that can be used once. In other words, it may be a single-use type device.

[0053] By the above operation, the blade 30 moves so as to rotate about its axis relative to the shaft portion 32, and as the blade 30 rotates about its axis, the skin is cut in a predetermined direction (a vertical cutting direction in the second embodiment).

[0054] -Description of Negative Pressure Generating Cylinder (See Figures 8 and 9)- Negative pressure generating cylinder 40 generates negative pressure within housing 20 by moving plunger 41 during blood collection. A preferred embodiment of negative pressure generating cylinder 40 may include a cylindrical cylinder body 40a extending in the direction in which plunger 41 moves, and plunger 41 that moves within cylinder body 40a to cause a change in volume.

[0055] The plunger 41 may include a disk portion 41a having a diameter approximately the same as the inner diameter of the cylinder body 40a, and a shaft core 41b protruding from the disk portion 41a toward the trigger member 50. A gasket G may be provided on the disk portion 41a to ensure close contact with the inner wall of the cylinder body 40a. The shaft core 41b may include an engagement groove for engaging with the trigger member 50 (plunger locking piece 53). A compression coil spring 60 may be attached to the shaft core 41b.

[0056] A pre-compressed compression coil spring 60 may be used to move the negative pressure generating cylinder 40. In other words, before blood collection, the compression coil spring 60 may be compressed toward the side where the trigger member 50 is located. When the compression of the compression coil spring 60 is released, the plunger 41 is moved, causing a volume change within the cylinder body 40a, and negative pressure can be generated.

[0057] In a preferred embodiment of the compression coil spring 60, the biasing direction of the compression coil spring 60 may be perpendicular to the direction in which the housing faces the skin. In other words, the biasing direction of the compression coil spring 60 may be parallel to the surface of the skin. By using such a biasing direction of the compression coil spring 60, it is possible to prevent the biasing force from acting in a direction perpendicular to the skin, thereby reducing the load on the skin.

[0058] Operation of the Negative Pressure Generating Cylinder Before blood collection, the plunger 41 is locked by the trigger member 50 (plunger locking piece 53) via the engagement groove. The compression coil spring 60 is compressed on the trigger member 50 side. In this state, when the trigger member 50 (plunger locking piece 53) is released from the lock, the plunger 41 moves in a direction away from the trigger member 50 due to the biasing force provided by the compression coil spring 60. More specifically, as the plunger 41 moves, the volume of the plunger 41 side of the cylinder body 40a gradually increases, generating negative pressure.

[0059] By generating negative pressure in the negative pressure generating cylinder 40, negative pressure can be generated in the blade space BS that communicates with the cylinder space SS. When the compression coil spring 60 is fully extended, the volume increase on the plunger 41 side of the cylinder body 40a ends, and the generation of negative pressure ends.

[0060] - Explanation of Trigger Member (See FIG. 10) - Trigger member 50 is a member that engages plunger 41 and blade 30 before blood collection so as to restrict the movement of both plunger 41 and blade 30, and that releases the engagement of both plunger and blade during blood collection, allowing the movement of blade 30 and plunger 41. The material of trigger member 50 may be the same resin material as housing 20, or may be a different material.

[0061] A preferred embodiment of the trigger member 50 may include an abutment portion 51 that abuts against the button 21b of the housing, a blade locking piece 52 that locks the movement of the blade, and a plunger locking piece 53 that locks the movement of the plunger.

[0062] Abutment portion 51 may be provided so as to extend in the direction in which housing 20 faces the skin. Abutment portion 51 may be configured to be pushed downward when button 21b of the housing is pressed. A spring B ( FIG. 2( a) ) having a repulsive force that resists the pressing of button 21b of the housing may be provided below abutment portion 51. Considering that the blood collection device of the present disclosure is a single-use device, button 21b may not restore its pressed state even when the repulsion of spring B occurs. In other words, button 21b may be housed in raised portion 21r when button 21b is pressed.

[0063] The blade locking piece 52 may be provided so as to protrude from the side surface of the abutment portion 51 toward the blade 30. The blade locking piece 52 may be engageable with the engaging portion of the slider member 71. The blade locking piece 52 may be pushed downward when the button 21 b of the housing is pressed, thereby releasing the engagement with the engaging portion of the slider member 71.

[0064] The plunger locking pieces 53 may be provided so as to extend toward each negative pressure generating cylinder 40. More specifically, the plunger locking pieces 53 may be arranged on the same straight line. When specifying the plunger locking pieces 53 from another perspective, in a plan view, the straight line connecting the plunger locking pieces 53 may be perpendicular to the direction in which the blade locking pieces 52 protrude. When specifying the plunger locking pieces 53 from yet another perspective, the straight line connecting the plunger locking pieces 53 may be perpendicular to the direction in which the housing 20 faces the skin.

[0065] In another preferred embodiment of the trigger member 50, the length L1 ( FIG. 3( b) ) of the blade locking piece 52 may be shorter than the length L2 ( FIG. 8( b) ) of the plunger locking piece 53. With this configuration, the blade 30 is first released from its engagement with the blade locking piece 52, and the blade 30 cuts the skin, and then the plunger 41 is released from its engagement with the plunger locking piece 53. In other words, after the skin is cut by the blade 30, the negative pressure generating cylinder 40 creates a negative pressure in the blade space BS, allowing the collected blood to be taken into the housing 20.

[0066] The reason why it is useful to release the lock of the blade 30 first and then the lock of the negative pressure generating cylinder 40 as described above will be explained with reference to FIG.

[0067] If the blade 30 is released first and then the negative pressure generating cylinder 40 is released, as shown in Figure 11(a), when the blade 30 cuts the skin S, no negative pressure is generated in the blade space BS, preventing the skin S from penetrating into the blade space BS. If the skin S does not enter the blade space BS, the depth to which the blade 30 penetrates the skin S can be maintained at a constant depth.

[0068] On the other hand, if the negative pressure generating cylinder 40 is released first and then the blade 30 is released, as shown in FIG. 11B, the blade 30 will cut the skin S while negative pressure is being generated in the blade space BS by the negative pressure generating cylinder 40. In other words, the skin S is cut while it is in the blade space BS. Here, since the hardness of the skin S differs from subject to subject, the amount of skin S that enters the blade space BS differs from subject to subject. As a result, the depth to which the blade 30 penetrates the skin S differs from subject to subject, and the cutting of the skin by the blade 30 is not stable.

[0069] Based on the above, a preferred embodiment of the trigger member 50 is to make the length L1 (Figure 3(b)) of the blade locking piece 52 shorter than the length L2 (Figure 8(b)) of the plunger locking piece 53, thereby releasing the lock on the blade 30 first and then releasing the lock on the negative pressure generating cylinder 40.

[0070] -Description of How to Use the Blood Collection Device- A method of using the blood collection device of the present disclosure will be described with reference to Figures 12 to 15. First, a storage container T for storing collected blood is prepared (Figure 12(a)). The outer shape of the storage container T may be shaped to fit into the mounting portion (opening 23) of the housing described above.

[0071] After preparing the storage container T, the storage container T is attached to the attachment portion (opening 23) of the blood collection device 1 (FIG. 12(b)). If a gasket G is provided at the attachment portion (opening 23), the blood collection device 1 and the storage container T can be attached in close contact with each other.

[0072] After the reservoir T is attached to the blood collection device 1, the blood collection device 1 is adhered to the skin (FIG. 13). If the adhesive member 22a is provided on the surface of the blood collection device 1 that faces the subject's skin, the blood collection device can be appropriately adhered to the subject's skin. Furthermore, by adhering the blood collection device to the skin, the opening 22h that communicates with the blade space BS is closed by the skin, so that the blade space BS can also be sealed.

[0073] When adhering the blood collection device 1 to the skin S, it is preferable to adhere the blood collection device 1 so that the storage container T attached to the blood collection device 1 faces the side where gravity acts (vertically downward). By adhering the blood collection device 1 to the skin S in this way, blood collected by the blood collection device 1 can be guided into the storage container T by its own weight.

[0074] After adhering blood collection device 1 to skin S, button 21b provided on housing 20 is pressed. Before button 21b is pressed, trigger member 50 is engaged with plunger 41 and blade 30 so as to restrict the movement of both plunger 41 and blade 30. By pressing button 21b in this state, trigger member 50 moves in a direction toward skin S. Accordingly, the engagement of both plunger 41 and blade 30 is released, allowing the movement of blade 30 and plunger 41.

[0075] More specifically, when the blade 30 is released from the blade locking piece 52 of the trigger member 50, the compression coil spring 60 is released and the slider member 71 slides. As the slider member 71 slides, the shaft 32 of the blade moves along the guide groove 72m of the guide member 72, causing the blade 30 to cut the skin. The operation of the blade 30 is as described in detail above in "Description of Operation of the Blade in the First Embodiment" and "Description of Operation of the Blade in the Second Embodiment."

[0076] Furthermore, when the plunger 41 is released from the plunger locking piece 53 of the trigger member 50, the compression coil spring 60 is released and the plunger 41 moves within the cylinder body 40a. In other words, a volume change occurs within the cylinder body 40a, generating negative pressure in the cylinder space SS and the blade space BS. The operation of the negative pressure generating cylinder 40 is as described in detail above in "Operation of the negative pressure generating cylinder."

[0077] As described in detail above in "-Explanation of the Trigger Member-", it is preferable that the trigger member 50 first releases the blade 30, and then releases the negative pressure generating cylinder 40. By releasing the blade 30 and the negative pressure generating cylinder in this way, the depth to which the blade 30 penetrates the skin can be maintained at a constant depth.

[0078] The collected blood flows through the flow path R in the housing 20 and is stored in the storage container T (see FIG. 14). In a preferred embodiment of the flow path R, the flow path R is inclined with respect to the surface of the housing 20 that faces the skin S. More specifically, it is preferred that the end of the flow path R on the storage container T side be inclined away from the surface. By inclining the flow path R in this way, the blood can be appropriately guided to the storage container T.

[0079] It is preferable that the blood stored in the storage container T can be seen from the outside (FIG. 15(a)). As an example, it is preferable that the storage container T is made of a transparent material. With such a configuration, it is possible to visually determine how much blood is stored in the storage container T.

[0080] 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 the storage container is transported to a testing facility.

[0081] As described above, according to the blood collection device of the present disclosure, trigger member 50 releases the lock on both plunger 41 and blade 30 during blood collection, allowing movement of blade 30 and plunger 41, eliminating the need to provide separate components that act as triggers for operating blade 30 and plunger 41. Therefore, blood can be collected appropriately with a simple structure.

[0082] The embodiments disclosed herein are illustrative in all respects and are not intended to be limiting. Therefore, the technical scope of the present disclosure should not be interpreted solely by the above-described embodiments, but should be defined by the claims. The technical scope of the present disclosure also includes all modifications within the meaning and scope of the claims. For example, the shape and / or color of the housing of a blood collection device or blood collection and storage device may be changed depending on the blood collection application and / or customer. For example, the shape of the housing may be changed to a rectangular and / or circular shape depending on the blood collection application and / or customer, and / or the color of the housing button may be changed depending on the blood collection application and / or customer.

[0083] The blood collection device and blood collection and storage device of the present disclosure may include the following preferred embodiments. First Aspect: A blood collection device having a flow path that guides collected blood to a storage container, comprising: a housing; a blade that protrudes from the housing and moves to cut the skin in one direction; a negative pressure generating cylinder that generates negative pressure within the housing by moving a plunger; and a trigger member that is housed in the housing and is activated when blood collection begins, wherein the trigger member engages with the plunger and the blade so as to restrict movement of both the plunger and the blade, and allows movement of the blade and the plunger when the engagement of both the plunger and the blade is released. Second Aspect: A blood collection device according to the first aspect, wherein a pre-compressed coil spring is used to move the plunger and / or the blade. Third Aspect: A blood collection device according to the second aspect, wherein movement of the blade is achieved by a movable body that rotates the blade about its axis by the biasing force provided by the compressed coil spring. Aspect 4: The blood collection device of Aspect 3, wherein the movable body comprises: a slider member that holds one end of the blade and is movable by the biasing force of the coil spring; and a guide member having a guide groove formed therein that houses a shaft that rotates the blade about its axis. Aspect 5: The blood collection device of Aspect 4, wherein the guide groove of the guide member is provided parallel to the direction in which the housing faces the skin. Aspect 6: The blood collection device of Aspect 4 or Aspect 5, wherein the shaft moves along the guide groove of the guide member. Aspect 7: The blood collection device of any of Aspects 4 to 6, wherein the slider member has a groove formed on a diagonal line, and one end of the blade moves along the diagonal groove. Aspect 8: The blood collection device of any of Aspects 4 to 7, wherein the direction in which the blade cuts the skin is perpendicular to the direction of gravity when the blood collection device is adhered to the skin.Aspect 9: The blood collection device of Aspect 4, wherein one end of the blade moves in the same direction as the biasing direction of the coil spring as the slider member moves. Aspect 10: The blood collection device of Aspect 9, wherein the direction in which the blade cuts the skin is the direction of gravity when the blood collection device is adhered to the skin. Aspect 11: The blood collection device of any of Aspects 2 to 10, wherein the biasing direction of the coil spring used to move the plunger and / or the blade is perpendicular to the direction in which the housing faces the skin. Aspect 12: The blood collection device of any of Aspects 1 to 11, wherein an adhesive member is provided on the surface of the housing facing the skin. Aspect 13: The blood collection device of any of Aspects 1 to 12, wherein the trigger member releases the engagement of the plunger after releasing the engagement of the blade. Aspect 14: The blood collection device of Aspect 13, wherein the trigger member comprises: a blade locking piece that locks the movement of the blade; and a plunger locking piece that locks the movement of the plunger, and the length of the blade locking piece is shorter than the length of the plunger locking piece. Aspect 15: The blood collection device of any of Aspects 1 to 14, wherein the space in the housing that accommodates the blade generates negative pressure by the negative pressure generating cylinder. Aspect 16: The blood collection device of any of Aspects 1 to 15, wherein at least the periphery of the space that accommodates the blade is sealed by an airtight member. Aspect 17: The blood collection device of any of Aspects 1 to 16, wherein the negative pressure generating cylinders are disposed on both sides of the space that accommodates the blade. Aspect 18: The blood collection device of any of Aspects 1 to 17, wherein the housing is provided with an attachment portion for attaching the storage container on the side in the direction of gravity when the blood collection device is adhered to the skin. Aspect 19: The blood collection device according to aspect 18, wherein the flow path communicating with the attachment portion is inclined with respect to a surface of the housing facing the skin.A 20th aspect: A blood collection and storage device comprising: a blood collection device according to any one of the first to 19th aspects; and a storage container positioned on the gravity side when the blood collection device is attached to the skin, for storing blood collected by the blood collection device.

[0084] The blood collection device and blood collection / reservoir device of the present disclosure are used to collect blood from a subject or to reserve collected blood.

[0085] REFERENCE SIGNS LIST 1 Blood collection device 20 Housing 21 First body 21b Button 21r Raised portion 22 Second body 22a Adhesive member 22h Opening of second body 23 Mounting portion (opening) 30 Blade 31 End portion 32 Shaft portion 40 Negative pressure generating cylinder 40a Cylinder body 41 Plunger 41a Disk portion 41b Shaft core 50 Trigger member 51 Abutment portion 52 Blade locking piece 53 Plunger locking piece 60 Compression coil spring 70 Movable body 71 Slider member 71m Groove 71h Holding portion 72 Guide member 72m Guide groove 80 Adhesive member 90 Airtight member 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, Housing and a blade protruding from the housing and movable to cut the skin in one direction; a negative pressure generating cylinder that generates negative pressure in the housing by moving a plunger; a trigger member that is accommodated in the housing and that is actuated when blood collection is started, The trigger member is The plunger and the blade are engaged to restrict movement of both the plunger and the blade, A blood collection device that allows movement of the blade and plunger when both the plunger and the blade are unlocked.

2. The blood collection device according to claim 1 , wherein a pre-compressed compression coil spring is used to move the plunger and / or the blade.

3. The blood sampling device according to claim 2 , wherein the blade is moved by a movable body that rotates the blade axially by a biasing force provided by the compression coil spring.

4. The movable body is a slider member that holds one end of the blade and is movable by the biasing force of the compression coil spring; A guide member having a guide groove for accommodating a shaft portion for axially rotating the blade; The blood collection device of claim 3 .

5. The blood sampling device according to claim 4 , wherein the guide groove of the guide member is provided parallel to a direction in which the housing faces the skin.

6. The blood sampling device according to claim 5 , wherein the shaft portion is movable along the guide groove of the guide member.

7. The slider member has a diagonal groove formed therein, The blood collection device according to claim 4 , wherein one end of the blade is movable along the diagonal groove.

8. The blood sampling device according to claim 7 , wherein a direction in which the blade cuts the skin is perpendicular to a direction of gravity when the blood sampling device is attached to the skin.

9. The blood sampling device according to claim 4 , wherein the slider member has one end of the blade movable in the same direction as the biasing direction of the compression coil spring.

10. The blood sampling device according to claim 9 , wherein a direction in which the blade cuts the skin is a direction of gravity when the blood sampling device is attached to the skin.

11. The blood collection device according to claim 2 , wherein the biasing direction of the compression coil spring used to move the plunger and / or the blade is perpendicular to the direction in which the housing faces the skin.

12. The blood sampling device according to claim 1 , wherein an adhesive member is provided on a surface of the housing that faces the skin.

13. The blood collection device of claim 1 , wherein the trigger member unlocks the plunger after unlocking the blade.

14. The trigger member is a blade locking piece that locks the movement of the blade; and a plunger locking piece that locks the movement of the plunger, The blood collection device of claim 13 , wherein the length of the blade locking piece is less than the length of the plunger locking piece.

15. The blood sampling device according to claim 1 , wherein a negative pressure is generated in a space in the housing that accommodates the blade by the negative pressure generating cylinder.

16. The blood sampling device according to claim 1 , wherein at least a periphery of a space housing the blade is sealed by an airtight member.

17. The blood collection device according to claim 1 , wherein the negative pressure generating cylinders are disposed on both sides of a space that houses the blade.

18. The blood sampling device according to claim 1 , wherein the housing is provided with an attachment portion for attaching the storage container on a side facing the direction of gravity when the blood sampling device is attached to the skin.

19. The blood collection device according to claim 18 , wherein the flow path communicating with the attachment portion is inclined with respect to a surface of the housing facing the skin.

20. A blood sampling device according to any one of claims 1 to 19, A blood collection and storage device comprising: a storage container that is positioned on the side of the blood collection device in the direction of gravity when the blood collection device is attached to the skin, and that stores blood collected by the blood collection device.