Puncture instrument

Abstract

This puncture instrument comprises a lancet 101, a housing member 106 including a housing body 102 and an operation part 104, and a biasing member 103. The operation part 104 has: an operation part-side engagement part 142 that releasably engages a hub-side engagement part 114 provided to a lancet hub 112; and an operation button 145 that is provided on a side of the housing body 102 and displaces the operation part-side engagement part 142. As a result of the operation button 145 being operated and moving in a direction orthogonal to the axial direction of the lancet hub 112, the operation part-side engagement part 142 moves in a direction orthogonal to the movement direction of the operation button 145 and the axial direction of the lancet hub 112, thereby releasing the engagement with the hub-side engagement part 114.

Description

Puncture device

[0001] The present disclosure relates to a lancing device.

[0002] When measuring blood glucose levels, etc., blood may be collected by puncturing the surface of the skin and allowing a small amount of blood to seep out. For such blood collection, a puncturing device may be used that uses the force of a spring to project a lancet with a puncture needle at the tip. For example, there is a disposable puncturing device in which the puncture needle is projected by pressing an operation button provided on a housing that houses the lancet.

[0003] One proposed disposable puncture device is an operating mechanism that includes a rotatable locking ring with a through-hole. By rotating the locking ring to a predetermined angle, a protrusion on a lancet can pass through the through-hole, thereby performing puncture (see, for example, Patent Document 1). An operating mechanism using a rotatable locking ring is configured such that the locking ring, which holds the lancet hub in a puncture-ready position, is displaced around its axis by a finger-operated operating button, and the user's operation function and the function of holding the lancet hub are realized by separate components. Therefore, compared to an operating mechanism in which the lancet hub and operating button are integrally formed, the load from the biasing member is less likely to reach the operating button, reducing the risk of deformation of the operating button and resulting in superior operational stability.

[0004] Japanese Patent Application Laid-Open No. 2012-5518

[0005] However, operating mechanisms using a locking ring that rotates around an axis require high precision during manufacturing because even slight deviations in the orientation or position of the locking ring during assembly of parts affect operation. This makes mass production prone to defects, resulting in unstable operational performance. Therefore, there is a need for a puncture device with excellent operational stability, different from operating mechanisms using a locking ring.

[0006] An object of the present disclosure is to realize a puncture device with excellent operational stability.

[0007] One aspect of the puncture device disclosed herein comprises a lancet having a lancet hub and a puncture needle integrated with the lancet hub, a housing member having a housing main body that houses the lancet, and a biasing member attached to the base end of the lancet hub and biasing the lancet hub toward the tip, the housing member having an operating portion that moves the lancet hub from a puncture preparation position in which the puncture needle is housed in the housing main body to a puncture position in which the puncture needle protrudes from the housing main body, the lancet hub having a hub-side engaging portion that engages with the operating portion, the operating portion having an operating portion-side engaging portion that releasably engages with the hub-side engaging portion to hold the lancet hub in the puncture preparation position, and an operating button for displacing the operating portion, the operating button being provided on the side of the housing and operable to move in a direction perpendicular to the axial direction of the lancet hub, and when the operating button is displaced in a direction perpendicular to the axial direction of the lancet hub, the operating portion-side engaging portion is displaced in a direction perpendicular to the axial direction of the lancet hub and the moving direction of the operating button, thereby disengaging from the hub-side engaging portion.

[0008] According to one aspect of the puncture device, when the operation button is operated to move in a direction perpendicular to the axial direction of the lancet hub, the operation unit-side engagement part is displaced in a direction perpendicular to the axial direction of the lancet hub and the movement direction of the operation button, thereby disengaging from the hub-side engagement part. The operation unit-side engagement part, which functions to hold the lancet hub, and the operation button, which performs the user's operation, are configured to move in different directions, and the biasing force from the biasing member is received by the operation unit-side engagement part, so the biasing force from the biasing member is not applied to the operation button. This reduces the risk of deformation of the operation button and provides superior operational stability compared to a configuration in which the lancet hub and the operation button are integrally formed and the operation button holds the lancet hub in the puncture preparation position. Furthermore, the operation unit-side engagement part, which holds the lancet hub in the puncture state, moves in a direction perpendicular to the axial direction of the lancet hub and the movement direction of the operation button, and does not require complex movement such as rotation around the lancet hub's axis. Because the operation of the operating part engaging part during use is simple, the precision required during manufacturing can be kept low, and the operating part engaging part is less likely to interfere with the movement of the lancet hub, resulting in a puncture device with excellent operational stability.

[0009] In one aspect of the puncture device, the housing main body has a housing main body portion, a nose portion attached to the tip side of the housing main body portion, and a protrusion formed integrally with the housing main body portion or the nose portion and protruding toward the lancet hub held in the puncture preparation position, and the operation unit side engaging portion can be provided on the protrusion. By providing the operation unit side engaging portion on the protrusion formed integrally with the housing main body portion or the nose portion, it is not necessary to provide an engaging mechanism for the operation unit side engaging portion in the housing main body, compared to when the operation unit side engaging portion is formed as a separate member from the housing main body, and the number of parts is also reduced, which is expected to facilitate assembly and reduce manufacturing costs.

[0010] In one aspect of the puncture device, the protrusion has a notch facing the operation button, and the operation button has an action convex portion that acts on the protrusion. When the operation button is operated, the action convex portion is inserted into the notch, moving the operation unit side engagement portion in a direction away from the lancet hub. The notch allows the protrusion provided with the operation unit side engagement portion to move smoothly, resulting in a stable puncture operation. In addition, the operation button must be pressed properly so that the action convex portion is inserted into the notch, reducing the risk of malfunction.

[0011] In one aspect of the puncture device, the protrusion has a deformable portion at the tip end that is more easily deformed than the base end of the protrusion, and the action convex portion can be configured to press the base end of the protrusion when the operation button is operated. With this configuration, the protrusion can be displaced significantly by the action convex portion, thereby ensuring stable disengagement between the operation unit-side engaging portion and the hub-side engaging portion.

[0012] In one aspect of the puncture device, a plurality of notches may be provided. Alternatively, the notches may be provided in pairs, and the pair of notches may be arranged to face each other across the lancet hub. This configuration makes it easier for the protrusion to be displaced, resulting in more stable operation.

[0013] In one aspect of the puncture device, the operation button has an action protrusion extending toward the inside of the housing body, the housing body having first and second walls facing each other with the lancet hub sandwiched therebetween, the operation unit-side engagement portion being provided on the first and second walls, and when the operation button is operated, the action protrusion is inserted between the first and second walls to widen the gap between the first and second walls. This configuration makes it easy to form an operation unit-side engagement portion that can be disengaged from the hub-side engagement portion by using the action protrusion. Furthermore, the operation unit-side engagement portions are located on both sides of the lancet hub, and the puncture operation does not begin simply by disengaging one of the operation unit-side engagement portions from the hub-side engagement portion. This reduces the likelihood of unintended punctures, achieving more stable operability.

[0014] In this case, the first wall and the second wall can be formed as members integral with the housing body, which is expected to facilitate assembly and reduce manufacturing costs, but they can also be formed as members separate from the housing body. For example, a configuration can be adopted in which members formed separately from the housing body are assembled to the housing body or nose portion so as to be slidable in a direction perpendicular to the axial direction of the lancet hub.

[0015] In one aspect of the puncture device, the hub-side engaging portion is an engaging protrusion that protrudes radially outward from the lancet hub, the lancet hub has a depth-setting protrusion that protrudes radially outward at a position circumferentially offset from the engaging protrusion, and the housing main body has a puncture depth setting portion located distally of the operating portion that the depth-setting protrusion collides with to restrict distal movement of the lancet hub and determine the puncture depth. This configuration allows the puncture depth to be set accurately. Furthermore, by providing the depth-setting protrusion separately from the engaging protrusion to which force is applied in the puncture preparation state, the protrusion is less likely to be damaged by collision, improving reliability.

[0016] In one aspect of the puncture device, the puncture device may have a return stop that prevents the hub-side engaging portion, which has moved distally beyond the operating portion-side engaging portion, from moving proximally beyond the operating portion-side engaging portion. This configuration ensures that the puncture device can be used only once, improving safety.

[0017] In one aspect of the puncture device, the lancet hub has a guide protrusion located closer to the base end than the hub-side engaging portion, and the housing main body has a guide rail that engages with the guide protrusion, and the guide protrusion and guide rail can guide the hub-side engaging portion to a position where it engages with the operating unit-side engaging portion. With this configuration, the lancet hub can be held in the puncture preparation position without failure by engaging the hub-side engaging portion with the operating unit-side engaging portion, thereby improving operational stability.

[0018] The puncture device of the present disclosure can improve operational stability.

[0019] FIG. 1 is an exploded perspective view showing a puncture device of one embodiment. FIG. 2 is a perspective view showing a nose portion. FIG. 3 is a side view showing an initial state of a puncture device of one embodiment, excluding a housing main body and a spring. FIG. 4 is a cross-sectional view showing an initial state of a puncture device of one embodiment. FIG. 5 is a side view showing a puncture device of one embodiment in a state ready to puncture, excluding a housing main body and a spring. FIG. 6 is a cross-sectional view showing a puncture device of one embodiment in a state ready to puncture. FIG. 7 is a cross-sectional perspective view taken along line VII-VII in FIG. 6.

[0020] As shown in Figures 1 to 7, the puncture device of this embodiment has a lancet 101, a housing member 106 including a housing main body 102 that houses the lancet 101 and an operating section 104, and a compression coil spring 103 that is a biasing member that biases the lancet 101.

[0021] The lancet 101 has a puncture needle 111 with a sharp tip and a lancet hub 112 that holds the puncture needle 111. The lancet hub 112 is rod-shaped, with the puncture needle 111 fixed to its tip and a spring receiver 113 that receives the spring 103 at its base end. The side of the lancet hub 112 is provided with a hub-side engagement portion 114, a depth-setting projection 115, and a guide projection 116, which are convex portions that protrude radially outward. In this embodiment, two of each of the hub-side engagement portion 114, the depth-setting projection 115, and the guide projection 116 are provided, one on either side of the central axis of the lancet hub 112. The hub-side engagement portion 114, the depth-setting projection 115, and the guide projection 116 are circumferentially offset by 90°, while the depth-setting projection 115 and the guide projection 116 are circumferentially aligned. The hub-side engaging portion 114 and the depth-setting protrusion 115 are provided at substantially the same position on the tip side of the lancet hub 112, and the guide protrusion 116 is provided on the base end side.

[0022] The housing body 102 is cylindrical and has an opening 123 at its tip. In this embodiment, the housing body 102 has a housing body portion 121 and a nose portion 122 attached to the tip of the housing body portion 121. A spring 103 is housed in the base end of the housing body portion 121. The spring 103 biases the lancet hub 112, which is housed in the housing body 102 with the puncture needle 111 facing the opening 123, in a direction in which the puncture needle 111 protrudes from the opening 123.

[0023] The operating unit 104 holds the lancet hub 112 biased toward the tip in a puncture preparation position, and when operated, releases the hold on the lancet hub 112 to perform the puncture operation. In this embodiment, the operating unit 104 has an operating button 145 partially exposed on the outside of the housing main body 102, and an operating unit-side engaging part 142 that is disposed inside the housing main body 102 and is a separate part from the operating button 145, and engages with the hub-side engaging part 114 to receive the biasing force of the spring 103. By operating the operating button 145, the engagement between the hub-side engaging part 114 and the operating unit-side engaging part 142 is released, thereby releasing the biasing force of the spring 103 and moving the lancet hub 112 toward the tip, thereby performing the puncture operation.

[0024] When unused, a needle cover 105 that protects the puncture needle 111 is connected to the tip of the lancet hub 112. The needle cover 105 is rod-shaped with the same central axis as the lancet hub 112 and is formed integrally with the tip of the lancet hub 112. The boundary between the lancet hub 112 and the needle cover 105 is a constricted threaded portion 153 with a reduced outer diameter, and the needle cover 105 can be manually removed from the lancet hub 112 by twisting the needle cover 105 around its central axis relative to the lancet hub 112 to thread off the threaded portion 153. By removing the needle cover 105 from the lancet hub 112, the tip of the puncture needle 111 that was covered by the needle cover 105 can be exposed.

[0025] The tip portion of the needle cover 105 is a flat grip portion 155, and the base end of the grip portion 155 has a cover side protrusion 151 and a tongue-shaped elastic claw 152 formed to protrude from both widthwise sides. When the needle cover 105 is attached in an unused state, the cover locking protrusion 128 of the nose portion 122 is sandwiched and locked between the cover side protrusion 151 and the elastic claw 152. In this state, the biasing force of the spring 103 is received by the engagement portion between the cover side protrusion 151 and the elastic claw 152 and the cover locking protrusion 128. The lancet hub 112 is held in an unused position in which the hub side engagement portion 114 is located closer to the base end than the operation unit side engagement portion 142.

[0026] In an unused state, the grip portion 155 at the tip of the needle cover 105 protrudes from the opening 123 at the tip of the housing body 102. By gripping and twisting the protruding grip portion 155, the threaded portion 153 is threaded off, and the cover-side protrusions 151 and elastic claws 152 are disengaged from the cover locking protrusions 128, allowing the needle cover 105 to be pulled out toward the tip. This causes the lancet hub 112 to advance toward the tip, and the lancet hub 112 is held in a puncture preparation position where the hub-side engagement portion 114 abuts against the operating unit-side engagement portion 142. By configuring the lancet hub 112 to advance toward the tip when the needle cover 105 is removed, it is no longer necessary to abut the hub-side engagement portion 114 and the operating unit-side engagement portion 142 before use, making it less likely that the urge of the spring will have an adverse effect on the hub-side engagement portion 114 or the operating unit-side engagement portion 142. Furthermore, when the needle cover 105 is removed and the hub-side engaging portion 114 and the operating unit-side engaging portion 142 come into contact, and from the time the hub-side engaging portion 114 and the operating unit-side engaging portion 142 come into contact until the user operates the operating button 145, the operating unit-side engaging portion 142 receives the biasing force from the spring, but the operating button 145 does not receive the biasing force from the spring, preventing the operating button from being deformed and malfunctioning. Alternatively, the lancet hub 112 may not advance toward the tip end when the needle cover 105 is removed, and the hub-side engaging portion 114 and the operating unit-side engaging portion 142 may always be in contact before the needle cover 105 is removed.

[0027] In the puncture preparation state in which the lancet hub 112 is biased and held in the puncture preparation position, operating the operation button 145 disengages the operation unit-side engaging portion 142 from the hub-side engaging portion 114. This causes the hub-side engaging portion 114 to advance beyond the operation unit-side engaging portion 142, causing the tip of the puncture needle 111 to protrude from the opening 123 and perform puncturing. Note that in the puncture preparation state, the operation button 145 is spaced from the operation unit-side engaging portion 142 so that a gap is created between the operation button 145 and the operation unit-side engaging portion 142, making it less likely to malfunction. Furthermore, because it is necessary to displace the operation unit-side engaging portion 142 in a predetermined direction, a certain amount of force is required to disengage the hub-side engaging portion 114 from the operation unit-side engaging portion 142, thereby preventing unintended operation.

[0028] After puncturing, when the spring 103 returns to its normal state, the lancet hub 112 is pulled back to the puncturing completion position where the tip of the puncturing needle 111 is housed within the housing body 102, completing the puncturing operation. The operating unit-side engaging portion 142 functions as a return stop that prevents the hub-side engaging portion 114 from moving to the puncturing preparation position. The return stop can prevent the puncturing device from being reused after use. Note that a return stop that prevents the hub-side engaging portion 114 from moving to the puncturing preparation position on the proximal end side can also be provided separately from the operating unit-side engaging portion 142. Furthermore, the hub-side engaging portion 114 can be moved beyond the operating unit-side engaging portion 142 toward the proximal end to return to the puncturing preparation position, making the puncturing device reusable.

[0029] The operation unit 104 is configured such that, by operating the operation button 145, the operation unit-side engagement portion 142 is displaced and disengaged from the hub-side engagement portion 114. In this embodiment, the operation button 145 has a portion that protrudes from the outer surface of the housing main body 102, and can be moved radially inward by pressing it. By pressing the operation button 145, the operation unit-side engagement portion 142 is displaced in a direction perpendicular to the axial direction of the lancet hub 112 and the movement direction of the operation button 145. This causes the operation unit-side engagement portion 142 to move away from the lancet hub 112 and disengage from the hub-side engagement portion 114. In this embodiment, the operation unit-side engagement portion 142 is configured to displace in a predetermined direction without rotating about its axis, making it easy to fix the operation unit-side engagement portion 142 during assembly. This reduces the required precision during assembly.

[0030] In this embodiment, the operating unit-side engaging portion 142 is formed on a protrusion 141 that protrudes from the nose portion 122 toward the base end of the lancet hub 112. As a result, the operating unit-side engaging portion 142 is automatically positioned relative to the housing main body 102, which facilitates assembly and reduces manufacturing costs compared to when the operating unit-side engaging portion 142 and the housing main body 102 are separate. Furthermore, a fixing mechanism is provided that fixes the nose portion 122 and the housing main body 121 in a fixed positional relationship, and the lancet 101 is assembled to the housing main body 121 in a state where rotation around its axis is restricted. Therefore, when the lancet 101 is assembled to the housing member 106, the operating unit-side engaging portion 142 is automatically positioned relative to the lancet 101. Furthermore, because operation button 145 is provided on housing main body 121, aligning nose portion 122 with housing main body 121 automatically aligns protrusion 141, on which operation portion side engagement portion 142 is provided, with operation button 145. All of these features can improve the ease of assembly of the puncture device.

[0031] The protrusion 141 can be molded integrally with the nose portion 122. In this case, the operating unit-side engaging portion 142 can be positioned in a predetermined position simply by assembling the nose portion 122 and the housing main body 121, which is preferable. However, the protrusion 141 molded separately from the nose portion 122 can also be assembled to the nose portion 122 by fitting, or fixed to the nose portion 122 by loose fitting, adhesive, welding, or the like. The protrusion 141 can also be provided on the housing main body 121. In this case, the housing main body 121 and the protrusion 141 can be molded integrally, or a separately formed member can be assembled or fixed to the housing main body 121. Furthermore, the protrusion 141 can be configured not to be directly assembled or fixed to the housing main body 121 or the nose portion 122, but to be indirectly assembled or fixed via another member. In this embodiment, the protrusion 141 protrudes from the nose portion 122 toward the base end, but the direction of protrusion can be selected depending on the positional relationship between the protrusion 141 and the lancet hub 112 held in the puncture preparation position.

[0032] The protruding portion 141 can have various configurations in which, when the operating button 145 is pressed, it is deflected and displaced in the axial direction of the lancet hub 112 and in a direction perpendicular to the pressing direction of the operating button 145, and moves away from the lancet hub 112. In this embodiment, the protruding portion 141 is configured to have a first wall 143 and a second wall 144 that protrude from the nose portion 122 toward the base end side.

[0033] The first wall 143 and the second wall 144 are arranged substantially parallel to each other with the lancet hub 112 sandwiched therebetween. A first notch 161 cut out from the base end toward the tip end is formed in the protrusion 141 at a position facing the operation button 145. A second notch 162 is formed on the opposite side of the first notch 161 with the lancet hub 112 in between. In this embodiment, the first notch 161 and the second notch 162 extend from the base end of the protrusion 141 to the nose portion 122, and are independent of the first wall 143 and the second wall 144. In this embodiment, the first notch 161 and the second notch 162 also function as a passage through which the depth-setting protrusion 115 passes.

[0034] The first wall 143 and the second wall 144 have a slot 148 extending in the axial direction. A bridge is formed in the slot 148 connecting both sides of the slot 148, leaving the slot 148 divided midway. The base end of the bridge forms an operating unit-side engaging portion 142 that can abut against the hub-side engaging portion 114. The hub-side engaging portion 114 of the lancet hub 112 is inserted into the slot 148 and abuts against and engages with the operating unit-side engaging portion 142. The distal end of the slot 148 functions as a deformation-facilitating portion that facilitates deformation of the protrusion 141. In this way, the distal end of the first wall 143 and the second wall 144 are set to have lower rigidity than the proximal end. The first wall 143 and the second wall 144 can be separate from the housing main body 102, and the first wall 143 and the second wall 144 can also be separate from each other. For example, the first wall 143 and the second wall 144, which is separate from the first wall 143, may each be assembled and fixed to the housing main body 102 so as to be movable in a predetermined direction. For example, at least one of the first wall 143 and the second wall 144 may be fixed so as to be slidable in a predetermined direction, and the housing main body 102 may be formed with a protrusion or the like that generates resistance when the wall 143 moves in the predetermined direction.

[0035] The bridge forming the operation unit-side engagement portion 142 can also be formed at the end of the protruding portion 141, rather than in the middle of the slot 148. In this case, the easily deformable portion can be formed large. The easily deformable portion can be formed as a through hole, a groove, or can be relatively thin and have a short width. Furthermore, it is preferable that at least a portion of the easily deformable portion is formed on the tip side of the axial center of the protruding portion 141, but it may also be formed on the base side of the axial center. Furthermore, it is preferable that the axial length of the easily deformable portion is longer than its width, and it is preferable that the easily deformable portion extends in the axial direction.

[0036] The hub-side engaging portion 114, inserted into the slot 148 from the base end side, abuts against the operating unit-side engaging portion 142 that divides the slot 148, and therefore cannot move beyond the operating unit-side engaging portion 142 toward the tip side of the slot 148, so the lancet hub 112 is held in the puncture preparation position. By applying force to the first wall 143 and the second wall 144, the first wall 143 and the second wall 144 are displaced away from the lancet hub 112 at the operating unit-side engaging portion 142, and the engagement between the hub-side engaging portion 114 and the operating unit-side engaging portion 142 can be released. This allows the hub-side engaging portion 114 to move past the operating unit-side engaging portion 142 toward the tip side of the slot 148.

[0037] The operation button 145 has an action protrusion 146 extending toward the inside of the housing main body 102. In this embodiment, the action protrusion 146 is formed by two opposing leg-like portions, with a cavity provided between the leg-like portions. The tip of the leg-like portion, which is the action protrusion 146, is chamfered to gradually thin, forming a wedge shape. The action protrusion 146 is located between the first wall 143 and the second wall 144, and by pressing the operation button 145, the wedge-shaped portion is inserted into a first notch 161 between the first wall 143 and the second wall 144. When the operation button 145 is further pressed, the wedge-shaped leg-like portions press the first wall 143 and the second wall 144 in a direction perpendicular to the pressing direction of the operation button 145, as shown in FIG. 7 , and the distance between them gradually increases. As a result, the operating unit side engaging portion 142 is displaced away from the lancet hub 112, disengaging from the hub side engaging portion 114, and the hub side engaging portion 114 moves further distally than the operating unit side engaging portion 142 to perform the puncture. The action convex portion 146 may be a single protrusion rather than a leg-like portion. The shape of the action convex portion and the position at which the action convex portion presses the protrusion can be changed as appropriate depending on the shape of the protrusion, etc. When the distal end of the protrusion is fixed and the operating unit side engaging portion is provided on the proximal end side which is the free end, it is preferable that the action convex portion presses the proximal end side rather than the axial center of the protrusion. Pressing the proximal end side which is the free end makes it easier to displace the protrusion.

[0038] When the tips of the first wall 143 and the second wall 144 that make up the protrusion 141 are fixed to the nose portion 122 and the operation unit-side engaging portion 142 is provided on the base end side that is the free end, it is preferable that at least the tip side have an easily deformable portion that is easier to deform than the base end side of the protrusion 141. By providing the easily deformable portion, when the action convex portion 146 presses the base end side of the protrusion 141 rather than the axial center, the operation unit-side engaging portion 142 can be easily displaced in the pressing direction of the action convex portion 146 and in a direction perpendicular to the axial direction, making it easier to release the engagement with the hub-side engaging portion 114.

[0039] In this embodiment, slots 148 provided in the first wall 143 and second wall 144 of the protrusion 141 function as the easily deformable portion. In this embodiment, the easily deformable portion is the slot 148 extending from the tip to the base end of the protrusion 141. However, the shape and position of the easily deformable portion can be appropriately changed depending on the shape of the protrusion, etc. For example, the easily deformable portion can be formed by a through-hole or groove, or by providing a thin portion that is thinner than other portions. The easily deformable portion can be provided closer to the tip than the axial center of the protrusion 141. However, from the viewpoint of facilitating displacement that releases the engagement between the operation unit-side engaging portion and the hub-side engaging portion, it is preferable that the easily deformable portion extend over as wide a range as possible in the axial direction. Note that a configuration without an easily deformable portion is also possible.

[0040] When the operation button 145 is pressed, a force is applied that widens the gap between the first wall 143 and second wall 144, which are the protrusion 141, but no force is applied directly to the lancet hub 112. This makes it less likely that the axis of the lancet will wobble during pricking, compared to when force is applied directly to the lancet hub from the operation button, or when force is applied to an arm portion provided on the lancet hub. Furthermore, unlike when the operation unit has a configuration that rotates around its axis relative to the housing, the protrusion 141 can be assembled while fixed to the housing main body 102, making it less likely to become misaligned and improving the reliability of the operation unit 104.

[0041] In this embodiment, the action convex portion 146 is configured as two wedge-shaped legs, each of which pushes apart the first wall 143 and the second wall 144. This ensures a passage for the depth-setting convex portion 115, which will be described later. However, various configurations that can push apart the first wall 143 and the second wall 144 can be employed. For example, a block-shaped convex portion can be configured to push apart both walls.

[0042] In this embodiment, the protrusion 141 has not only a first notch 161 on the operation button 145 side, but also a second notch 162 on the opposite side of the operation button 145 across the lancet hub 112. The second notch 162 allows the first wall 143 and second wall 144 of the protrusion 141 to be easily displaced when the operation button 145 is operated. However, the second notch 162 may not be provided. For example, the protrusion 141 may have a U-shaped cross section in which the first wall 143 and second wall 144 are connected on the opposite side of the operation button 145. The second notch 162 may also be provided at a position other than the position on the opposite side of the operation button 145 across the lancet hub 112 from the first notch 161. A total of three or more notches may also be provided on the protrusion 141.

[0043] In this embodiment, the first wall 143 and second wall 144 of the protrusion 141 are formed symmetrically on the operation button 145 side and the opposite side with the lancet hub 112 sandwiched between them. With this configuration, the nose portion 122 is rotationally symmetric, so that a product that functions correctly can be obtained even when the nose portion 122 and the housing main body 121 are assembled in a state rotated 180 degrees, thereby improving productivity. However, it is also possible to form protrusions that are asymmetric on the operation button 145 side and the opposite side with the lancet hub 112 sandwiched between them.

[0044] A configuration may also be adopted in which portions of the first wall 143 and the second wall 144 other than their tip portions are fixed to the nose portion 122. For example, portions of the first wall 143 and the second wall 144 opposite the operation button 145 may be fixed to the nose portion 122. Also, instead of fixing the first wall 143 and the second wall 144 directly to the nose portion 122, the first wall 143 and the second wall 144 may be fixed to an intermediate member, and this intermediate member may be fixed to the nose portion. Also, a configuration may be adopted in which the first wall 143 and the second wall 144 are fixed to the housing main body 121.

[0045] In this embodiment, pressing the operation button 145 causes both the first wall 143 and the second wall 144 to slightly displace outward, disengaging the operation unit-side engaging portion 142 from the hub-side engaging portion 114. By providing two engagement points with the lancet hub 112, even if one of the engagement points is accidentally disengaged, a puncture will not occur, further improving safety. However, it is also possible to have a configuration in which there is only one engagement point with the lancet hub 112 and only one of the first wall 143 and the second wall 144 displaces outward. It is also possible to have only one wall. Even when both the first wall 143 and the second wall 144 are displaced, there can still be only one engagement point with the lancet hub 112.

[0046] In this example, the hub-side engaging portion 114 is a convex portion that protrudes radially outward, and the operating unit-side engaging portion 142 is a bridge that divides the slot 148 into which the hub-side engaging portion 114 is inserted. This configuration ensures that the biasing force can be reliably received and allows for easy disengagement. In this embodiment, the operating unit-side engaging portion 142 has an arc-like shape with a raised center portion in the width direction of the slot 148. Furthermore, both sides of the slot 148 of the first wall 143 and the second wall 144 are slightly raised and thicker than the other portions in the portions from the base end to the operating unit-side engaging portion 142. This reinforces the base-end portion of the slot 148 and makes it less likely to deform due to the biasing force.

[0047] In this embodiment, the hub-side engaging portion 114 protruding from the lancet hub 112 is inserted into the slot 148, and as the lancet hub 112 moves toward the tip, the hub-side engaging portion 114 is guided by the slot 148, making it less likely for the axis to wobble during puncturing. Furthermore, the provision of the slot 148 makes it easier for the first wall 143 and the second wall 144 to be displaced when the operation button 145 is operated, allowing for smoother puncturing.

[0048] The hub-side engaging portion 114 and the operating unit-side engaging portion 142 are not limited to this configuration and can have various other engaging configurations. For example, the operating unit-side engaging portion can be a convex portion that protrudes inward and engages with a convex portion that protrudes from the lancet hub 112. Alternatively, the hub-side engaging portion can be a concave portion, and the operating unit-side engaging portion can be a convex portion that is inserted into the concave portion. In these configurations, it is possible to not provide slots in the first wall 143 and the second wall 144, but providing openings or slots can make it easier for the first wall 143 and the second wall 144 to be displaced.

[0049] In this embodiment, the operation button 145 has a base end fixed to the housing main body 121, a side end and a tip end separated from the housing main body 121 by slits, and a tip end side free end. Therefore, when the top plate portion of the operation button 145 exposed on the outside of the housing main body 121 is pressed to push the operation button 145 into the housing main body 121, the action convex portion 146 extending from the top plate portion to the inside of the housing main body 121 is pushed further inward into the housing main body 121. This causes the action convex portion 146 to be inserted into the first notch 161, displacing the operation unit-side engagement portion 142. The portion of the operation button 145 fixed to the housing main body 121 on the base end side has spring elasticity, and when pressure is released, the pushed-in operation button 145 returns to its original position. This causes the action convex portion 146 to disengage from the first notch 161, and the operation unit-side engagement portion 142 also returns to its original position.

[0050] The operation button 145 is not limited to this configuration, and various other configurations are possible in which, when operated, at least the operation unit-side engaging portion 142 of the protrusion 141 is displaced in a direction perpendicular to the axial direction and the pressing direction of the lancet hub 112. For example, the distal end of the operation button may be fixed to the housing main body 102, and the proximal end may be a free end. The operation button 145 may be molded integrally with the housing main body 121, or it may be formed by fixing a member formed separately from the housing main body 121 to the housing main body 121. The operation button 145 may also be provided on the nose portion 122 side, or a separate member may be inserted between the housing main body 121 and the nose portion 122 and the operation button 145 may be provided on this member.

[0051] It is preferable that the housing main body 121 and the nose portion 122 can be assembled together only when they are aligned in a certain positional relationship. This configuration allows the operation button 145 on the housing main body 121 to be easily aligned with the protrusion 141 on the nose portion 122. In this embodiment, the housing main body 121 and the nose portion 122 are coupled together by inserting four connecting claws 124 on the tip of the housing main body 121 into four connecting openings 125 on the base end of the nose portion 122. The connecting claws 124 and the connecting openings 125 are two-fold symmetric, and the protrusion 141 on the nose portion 122 is also two-fold symmetric. Therefore, by coupling the nose portion 122 to the housing main body 121, the operation button 145 and the protrusion 141 can be automatically aligned.

[0052] The method of connecting the housing main body 121 and the nose portion 122 is not limited to the above method, and various other methods can be used. The alignment of the operation button 145 and the protrusion 141 is also not limited to the above method, and various other methods can be used. The operation button 145 and the protrusion 141 can be formed in the same part of the housing main body 102, or can be formed as a single unit separate from the housing main body 102 and fixed to the housing main body 102 later.

[0053] In this embodiment, the lancet hub 112 has two guide protrusions 116 on its proximal end. The guide protrusions 116 are circumferentially offset from the engaging protrusions, which are the hub-side engaging portions 114. Two guide rails 127, into which the guide protrusions 116 can slide, are formed on the inner surface of the housing main body 121. The guide protrusions 116 and the guide rails 127 prevent the lancet hub 112 from rotating within the housing main body 102. This prevents the hub-side engaging portions 114 from wobbling and guides them to the operating unit-side engaging portion 142 when transitioning from the unused state to the puncture-ready state, thereby ensuring a more reliable transition to the puncture-ready state. This function can be made even more effective by providing a rotation restriction that restricts relative rotation between the nose portion and the needle cover. This also reduces wobble of the lancet hub 112 during puncture. However, the mechanism for preventing rotation of the lancet hub 112 can be changed to various types, and it is also possible to have a configuration without a rotation prevention mechanism.

[0054] One of the guide rails 127 is circumferentially aligned with the operation button 145, while the other is circumferentially offset by 180° from the operation button 145. Therefore, when the guide protrusions 116 are inserted into the guide rails 127 and the lancet hub 112 is housed in the housing main body 121, the hub-side engaging portion 114 protrudes in a direction offset by 90° from the operation button 145. Therefore, when the nose portion 122 is connected to the housing main body 121 so that the operation button 145 is aligned with the first wall 143 and second wall 144 of the protrusion 141, the hub-side engaging portion 114 is aligned with the slot 148, and the lancet hub 112 is inserted into the first notch 161 provided between the protrusions 141.

[0055] When the hub-side engaging portion 114 and the operating portion-side engaging portion 142 are disengaged and the lancet hub 112 moves toward the tip, the depth-setting protrusion 115 on the lancet hub 112 collides with the cover locking protrusion 128, restricting the lancet hub 112 from moving toward the tip, thereby ensuring a constant lancing depth. By also using the cover locking protrusion 128 as a housing-side lancing depth setting portion that sets the lancing depth, the number of protrusions formed on the inner surface of the nose portion 122 can be reduced, making manufacturing easier. However, a lancing depth setting portion separate from the cover locking protrusion 128 can also be provided.

[0056] In this embodiment, the depth-setting protrusion 115 is circumferentially offset by 90° from the hub-side engaging portion 114. In this embodiment, the depth-setting protrusion 115 is configured to pass between a first notch 161 and a second notch 162 provided in the protrusion 141. A guide groove or the like for guiding the movement of the depth-setting protrusion 115 can also be provided on the inner surface of the nose portion 122, closer to the tip than the portion where the protrusion 141 is formed. Providing a guide groove can further stabilize the puncturing operation.

[0057] In this embodiment, the distal end surface of the depth-setting protrusion 115 and the proximal end surface of the cover locking protrusion 128, which functions as the puncture depth setting portion on the housing side, are formed as horizontal surfaces that stand perpendicular to the axis of the puncture device. This allows the surfaces to collide with each other, improving the accuracy of the puncture depth. The proximal end surface of the depth-setting protrusion 115 is an inclined surface that gradually decreases in height toward the proximal end.

[0058] By providing the depth-setting protrusion 115, which collides with the protrusion on the housing side, separately from the hub-side engaging portion 114, which may be subject to a biasing force in the puncture preparation state and cause a deterioration in strength, the protrusion is less likely to be damaged, thereby improving reliability. Also, by providing the depth-setting protrusion 115 separately from the hub-side engaging portion 114, the degree of freedom in designing the puncture depth is improved. However, it is also possible to configure the hub-side engaging portion 114 to collide with the protrusion on the housing side.

[0059] The depth-setting protrusions on the lancet hub and the protrusions on the housing that set the lancing depth are not limited to the above arrangement and can be located in various positions. However, from the perspective of minimizing puncturing deviation, it is preferable for the collision to occur as close to the tip as possible. For example, it is preferable to locate the protrusions on the housing closer to the tip than the operating unit engaging portion 142, so that they collide with the depth-setting protrusions 115 on the lancet hub closer to the tip than the operating unit engaging portion 142. Other configurations can also be used as the mechanism for setting the lancing depth.

[0060] In this embodiment, the lancet hub 112 has a generally circular cross section. However, the shape of the lancet hub 112 can be modified in various ways, such as a generally square column with equal widths on each side, or a generally rectangular column with a narrower width on the side on which the depth-setting protrusions 115 and guide protrusions 116 are provided than on the side on which the hub-side engagement portion 114 is provided. Furthermore, the lancet hub 112 can also have ribs extending in the axial direction for reinforcement.

[0061] The puncture device of the present disclosure has excellent operational stability and is useful as a medical puncture device, etc.

[0062] REFERENCE SIGNS LIST 101 Lancet 102 Housing body 104 Operation unit 105 Needle cover 106 Housing member 111 Puncture needle 112 Lancet hub 114 Hub-side engagement unit 115 Depth-setting projection 116 Guide projection 121 Housing body 122 Nose 123 Opening 124 Connecting claw 125 Connecting opening 127 Guide rail 128 Cover-locking projection 141 Projection 142 Operation unit-side engagement unit 143 First wall 144 Second wall 145 Operation button 146 Action projection 148 Slot 151 Cover-side projection 152 Elastic claw 153 Threaded portion 155 Grip 161 First notch 162 Second notch

Claims

1. A device comprising: a lancet having a lancet hub and a puncture needle integrated with the lancet hub; a housing member having a housing main body that houses the lancet; and a biasing member attached to the base end of the lancet hub and biasing the lancet hub in the distal direction, wherein the housing member has an operating part that moves the lancet hub from a puncture preparation position in which the puncture needle is housed in the housing main body to a puncture position in which the puncture needle protrudes from the housing main body, the lancet hub has a hub side engaging part that engages with the operating part, and the operating part has an operating part side engaging part that releasably engages with the hub side engaging part to hold the lancet hub in the puncture preparation position, and an operating button that displaces the operating part side engaging part, wherein the operating button is provided on the side of the housing main body and can be operated to move in a direction perpendicular to the axial direction of the lancet hub, A puncture device in which, when the operation button moves in a direction perpendicular to the axial direction of the lancet hub, the operation unit side engagement portion is displaced in a direction perpendicular to the axial direction of the lancet hub and the direction of movement of the operation button, thereby releasing the engagement with the hub side engagement portion.

2. The puncture device according to claim 1, wherein the housing body has a housing body portion and a nose portion attached to the tip side of the housing body portion, and a protrusion formed integrally with the housing body portion or the nose portion and protruding toward the lancet hub held in the puncture preparation position, and the operating unit side engagement portion is provided on the protrusion.

3. The puncture device according to claim 2, wherein the protrusion has a notch at a position opposite the operation button, the operation button has an action convex portion that acts on the protrusion, and when the operation button is operated, the action convex portion is inserted into the notch, moving the operation part side engagement part in a direction away from the lancet hub.

4. The puncture device of claim 1, wherein the operation button has an action convex portion extending toward the inside of the housing main body, the housing main body has a first wall and a second wall facing each other with the lancet hub in between, the operation unit side engagement portion is provided on the first wall and the second wall, and when the operation button is operated, the action convex portion is inserted between the first wall and the second wall, widening the gap between the first wall and the second wall and moving the operation unit side engagement portion in a direction away from the lancet hub.

5. The puncture device according to claim 1, wherein the hub-side engaging portion is an engaging protrusion that protrudes radially outward from the lancet hub, the lancet hub has a depth-setting protrusion that protrudes radially outward at a position circumferentially offset from the engaging protrusion, and the housing main body has a puncture depth setting portion located further towards the tip than the operating part-side engaging portion with which the depth-setting protrusion collides to restrict movement of the lancet hub towards the tip, thereby determining the puncture depth.

6. The puncture device according to claim 1, further comprising a return stop portion that prevents the hub side engaging portion, which has moved further distally than the operating portion side engaging portion, from moving further proximally than the operating portion side engaging portion.

7. The puncture device according to claim 1, wherein the lancet hub has a guide protrusion located closer to the base end than the hub-side engaging portion, the housing body has a guide rail that engages with the guide protrusion, and the guide protrusion and the guide rail guide the hub-side engaging portion to a position where it engages with the operating unit-side engaging portion.

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