WO2012133267A1 - Dispositif de ponction - Google Patents

Dispositif de ponction Download PDF

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Publication number
WO2012133267A1
WO2012133267A1 PCT/JP2012/057689 JP2012057689W WO2012133267A1 WO 2012133267 A1 WO2012133267 A1 WO 2012133267A1 JP 2012057689 W JP2012057689 W JP 2012057689W WO 2012133267 A1 WO2012133267 A1 WO 2012133267A1
Authority
WO
WIPO (PCT)
Prior art keywords
casing
puncture
pressure contact
puncture device
state
Prior art date
Application number
PCT/JP2012/057689
Other languages
English (en)
Japanese (ja)
Inventor
安祐実 熊谷
哲也 大谷内
邦史 原
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2013507543A priority Critical patent/JP6014022B2/ja
Publication of WO2012133267A1 publication Critical patent/WO2012133267A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/150183—Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150587—Joining techniques used for protective means by friction fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit

Definitions

  • the present invention relates to a puncture device.
  • a blood glucose measuring device that automatically measures the amount of glucose in the blood is used to measure the blood glucose level. Prior to this measurement, the patient needs to collect his blood.
  • the fingertip puncture includes a puncture needle tip having a puncture needle and a casing for housing the puncture needle, a mounting portion to which the puncture needle tip is detachably mounted, and a plunger that is connected to the puncture needle in the mounted state.
  • a puncture device set (see, for example, Patent Document 1) configured with a puncture device is used.
  • the puncture needle tip with the cap attached is grasped with the finger of one hand
  • the puncture device is grasped with the finger of the other hand
  • the puncture needle tip is inserted into the puncture device and attached.
  • the cap is removed from the casing of the puncture needle tip, and then the exposed tip is pressed against the fingertip and the puncture device is operated by pressing the puncture button to momentarily project the puncture needle of the puncture needle tip from the tip opening. And puncture the fingertip.
  • the puncture needle tip is removed from the puncture device.
  • the puncture needle tip that has been once punctured is configured not to be used again.
  • An object of the present invention is to provide a puncture device that can prevent a casing of a puncture needle tip that has been attached from moving in a direction away from the attachment portion.
  • the present invention provides a puncture needle having a needle body having a sharp needle tip at a distal end, a needle hub fixed to the proximal end portion of the needle body, and the puncture needle in its axial direction.
  • a puncture device that is detachably mounted on a distal end portion of the puncture needle tip that is movably housed along a cylindrical casing having an opening through which the needle tip can protrude,
  • a hollow housing having a mounting portion at a tip portion to which the casing is detachably mounted; In a state where the casing is mounted on the mounting portion, the casing is disposed on the outer peripheral portion of the casing and pressed against the casing, and the casing is prevented from moving relative to the housing in a direction in which the casing is detached from the mounting portion.
  • a pressure contact member A first state in which the pressure contact member is movably installed with respect to the pressure contact member and is located inside the pressure contact member and the pressure contact member is not in pressure contact with the casing, and at least a part of the pressure contact member is retracted from the inside of the pressure contact member.
  • a switching member that switches to a second state in which the pressure contact member is in pressure contact with the casing;
  • a puncture device comprising: an ejection mechanism that moves the casing in a distal direction relative to the housing and removes the puncture needle tip from the puncture device.
  • the pressure contact member has an annular shape or a C-shape with a variable inner diameter.
  • the pressure contact member includes an insertion portion into which the switching member is inserted, and a pressure contact portion that is in pressure contact with the outer peripheral surface of the case.
  • the pressure contact member In the first state, the pressure contact member is expanded by inserting the switching member into the insertion portion, and in the second state, at least a part of the switching member is retracted from the insertion portion and contracted. It is preferable that it is diameter.
  • the pressure contact portion protrudes in a central axis direction of the mounting portion and presses the casing in a state where the casing is mounted on the mounting portion.
  • the switching member has an annular shape or a C shape.
  • the switching member has a large diameter portion and a small diameter portion having an inner diameter smaller than the large diameter portion.
  • the switching member has a guide surface at the distal end thereof for guiding the switching member when the switching member moves to the inside of the pressure contact member.
  • the pressure contact member is configured to be in the second state when the switching member is pressed by the casing and moves in the proximal direction.
  • the pressure contact member is configured to be in the first state when the switching member is pressed by the ejection mechanism and moves in the distal direction.
  • the switching member has a contact portion with which the casing contacts, When the puncture needle tip is mounted, the casing comes into contact with the contact portion, the switching member is pressed and moved by the casing, and at least a part of the switching member is retracted from the inside of the pressure contact member. It is preferable to be configured to be in the second state.
  • the housing has a cylindrical shape
  • the eject mechanism preferably includes an eject member installed in the housing so as to be movable in the axial direction with respect to the housing and pressing the base end portion of the casing to move the casing in the distal direction.
  • the eject member has a contact portion that contacts the switching member when the puncture needle tip is removed by the eject mechanism.
  • the contact portion abuts on the switching member, the switching member is pressed by the ejection member, and the switching member moves to the inside of the pressure contact member to move the first It is preferable that it is comprised so that it may be in the state of 1.
  • the puncture needle tip has a cap fitted to the casing, It is preferable that the pressure contact force of the pressure contact member to the casing is larger than the fitting force between the cap and the casing.
  • FIG. 1 is a perspective view showing a puncture device set composed of a puncture device of the present invention and a puncture needle tip.
  • FIG. 2 is a cross-sectional view of the puncture needle tip shown in FIG.
  • FIG. 3 is an exploded perspective view of the puncture device set shown in FIG.
  • FIG. 4 is an exploded perspective view of the front end member, collet, and ring of the puncture device shown in FIG.
  • FIG. 5 is a longitudinal sectional view showing a casing of a front end member, an eject member, a collet, a ring, and a puncture needle tip at the distal end portion of the puncture device shown in FIG.
  • FIG. 5A is a cross-sectional view showing a state before the puncture needle tip is mounted.
  • FIG.5 (b) is sectional drawing which shows the state in the middle of mounting
  • 6 is a longitudinal sectional view showing a casing of a front end member, an eject member, a collet, a ring, and a puncture needle tip at the distal end portion of the puncture device shown in FIG.
  • FIG. 6A is a cross-sectional view showing a state where the puncture needle tip is being attached to the puncture device.
  • FIG. 6B is a cross-sectional view showing a state in which the puncture needle tip is completely attached to the puncture device.
  • FIG. 7 is a longitudinal sectional view for explaining the operation of the puncture device set shown in FIG. FIG.
  • FIG. 7A is a cross-sectional view showing the puncture device and the puncture needle tip before being attached to the puncture device.
  • FIG. 7B is a cross-sectional view showing a state where the gripping bar of the plunger is engaged with the gripped protrusion of the hub when the puncture needle tip is attached to the puncture device.
  • FIG. 8 is a longitudinal sectional view for explaining the operation of the puncture device set shown in FIG.
  • FIG. 8A is a cross-sectional view showing a state in which the puncture needle tip is further pushed toward the rear end side of the puncture device, and the plunger is fixed by compressing the driving coil spring.
  • FIG. 8B is a cross-sectional view showing a state where the puncture needle tip is pushed further toward the rear end side, the engagement between the hub of the puncture needle tip and the casing is released, and the casing is attached to the attachment portion of the puncture device.
  • FIG. FIG. 9 is a longitudinal sectional view for explaining the operation of the puncture device set shown in FIG.
  • FIG. 9A is a cross-sectional view showing a state in which the needle protrudes by pressing the puncture button after the cap is removed from the puncture needle tip.
  • FIG. 9B is a cross-sectional view showing the moment when the sliding ring stops at the front bulge portion of the casing when the plunger moves backward.
  • FIG. 10 is a longitudinal sectional view for explaining the operation of the puncture device set shown in FIG.
  • FIG. 10A is a cross-sectional view showing a state where the pusher is pushed and the puncture needle tip is removed from the puncture device.
  • FIG. 10B is a cross-sectional view showing a state in which the sliding ring moves forward together with the casing by pushing the pusher and is detached from the elastic lever.
  • FIG. 11 is a longitudinal sectional view for explaining the operation of the puncture device set shown in FIG.
  • FIG. 11A is a cross-sectional view of the puncture needle tip after being removed from the puncture device.
  • FIG. 11B is a cross-sectional view showing a state where a used puncture needle tip is mounted on the puncture device.
  • FIG. 1 is a perspective view showing a puncture device set composed of the puncture device of the present invention and a puncture needle tip
  • FIG. 2 is a sectional view of the puncture needle tip shown in FIG. 1
  • FIG. 3 is shown in FIG. 4 is an exploded perspective view of the puncture device set
  • FIG. 4 is an exploded perspective view of the front end member of the puncture device shown in FIG. 1, a collet and a ring
  • FIGS. 5 and 6 are front end members at the distal end of the puncture device shown in FIG.
  • FIG. 7 to FIG. 11 are longitudinal sectional views for explaining the operation of the puncture device set shown in FIG. 1, showing the casing of the eject member, collet, ring and puncture needle tip.
  • the axial direction is the X direction
  • the X1 direction is “front end”, “front end”, or “front”
  • the X2 direction is “base end”, “rear end”, or “rear”.
  • the puncture device 1 shown in each figure is a device that is used by detachably attaching a puncture needle tip 12 to the tip, and in a state where the puncture needle tip 12 is attached, that is, in the state shown in FIG. Used to puncture.
  • the puncture device set 10 includes a puncture needle tip 12 and a puncture device 1 on which the puncture needle tip 12 is detachably attached to the tip.
  • the puncture needle tip 12 includes a tip body 13 and a cap 14 that is detachably attached to the tip body 13.
  • the chip body 13 includes a puncture needle 15 that punctures the skin, a sliding ring (movement limiting means) 16 that is engaged with the puncture needle 15, and a cylindrical casing that holds the puncture needle 15 slidably therein. 18.
  • the puncture needle 15 has a tip needle (needle body) 20 and a hub 22 that is molded or bonded integrally with the rear portion of the needle 20.
  • the hub (needle hub) 22 includes four elastic levers 24 protruding forward and arranged at equal angular intervals in the circumferential direction, a cylindrical sliding support portion 26 at the rear, and a gripped protrusion 28 protruding at the rear end.
  • the outer diameters of the sliding support portion 26 and the sliding ring 16 are substantially the same as the inner diameter of the casing 18 and can slide in the casing 18 in the axial direction.
  • the four elastic levers 24 are inserted into the sliding ring 16 and are in contact with the sliding ring 16.
  • the rear end surface of the sliding ring 16 is in contact with a minute step 24 a provided on the hub 22, and is pushed out simultaneously when the puncture needle 15 moves forward. Further, the contact portion of the elastic lever 24 with the sliding ring 16 has no protrusions or steps, and the sliding ring 16 is easily pulled out when the puncture needle 15 is retracted.
  • the casing 18 has a cylindrical shape with a reduced diameter portion 32 at the tip, an inner circumferential stepped portion 34 provided at the rear of the reduced diameter portion 32, and three slightly protruding to the inner circumferential surface slightly in the middle. It has a front bulging portion 36, a rear annular bulging portion 40 slightly projecting on the rear inner peripheral surface, and a skirt 41 provided on the middle outer periphery.
  • the front bulge portion 36 is a bulge portion that is low enough to allow the sliding ring 16 to get over when the puncture needle 15 advances.
  • the peripheral surface 30 of the sliding support part 26 is fitted and fixed to the rear annular bulging part 40 with an appropriate strength. This fitting is a so-called press-fit state.
  • the fitting between the circumferential surface 30 and the rear annular bulging portion 40 may be configured such that, for example, an appropriate undercut is provided on the circumferential surface 30 and the rear annular bulging portion 40 is fitted into the undercut.
  • the reduced diameter portion 32 has a shape that decreases in diameter toward the tip on both the outer peripheral surface and the inner peripheral surface, and a circular opening 42 is provided at the tip.
  • the skirt 41 is an annular body, and protrudes from the outer periphery of the casing 18 in a cross-sectional view (see FIG. 2) and extends to the rear end side to form a fitting gap 41a between the casing 18 and the skirt 41.
  • the cap 14 has a bottomed cylindrical shape, fits into the reduced diameter portion 32 of the casing 18, and closes the opening 42. That is, the cap 14 is detachably attached to the reduced diameter portion 32 and hermetically seals the opening 42.
  • the puncture device 1 is configured based on a case body 102, a dial portion 104 for setting a puncture depth, a plunger 106 that can advance and retreat in the axial direction,
  • the plunger 106 has a drive coil spring 108 coaxially arranged at the middle stage portion and a return coil spring 110 coaxially arranged at the rear end portion.
  • the case body 102 is hollow, and in the present embodiment, has a cylindrical shape.
  • the puncture device 1 further includes a rear end member 112 that rotatably holds the dial portion 104 on the rear end side of the case main body 102 and a puncture disposed in a hole 114 formed in a side portion on the front end side of the case main body 102.
  • a button 116 and a front end member 118 provided at the tip of the case body 102 and elastically holding the puncture button 116 so as to be displaceable inward.
  • the case main body 102, the rear end member 112, and the front end member 118 constitute the main part of the housing of the puncture apparatus 1.
  • the puncture device 1 is installed in the inner cavity of the rear end member 112 so as to be movable forward and backward with respect to the rear end member 112 and in the case main body 102 so as to be movable in the axial direction with respect to the case main body 102.
  • the plunger 106 includes a middle first spring seat 130 that supports one end of the drive coil spring 108, a pair of second spring seats 132 provided at the rear end in an outward hook shape, and a gripped protrusion of the hub 22. 28, an elastic piece 136 extending forward from the upper middle step portion, and a small protrusion 138 provided at a slightly lower rear portion.
  • the gripping bar 134 constitutes a mounting portion to which the puncture needle 15 is detachably mounted.
  • the front end side inner surface of the rear end member 112 has a plurality of stepped portions 139 arranged in the circumferential direction and having different heights in the axial direction.
  • the staircase portion 139 is for adjusting the protruding length of the needle 20 by the small protrusion 138 of the plunger 106 abutting when the plunger 106 moves forward vigorously during puncturing. That is, the stepped portion 139 moves in the circumferential direction by rotating the dial portion 104, and the protruding length of the needle 20 is adjusted by the height of the stepped portion 139 with which the small protrusion 138 comes into contact, and the puncture depth Can be adjusted.
  • the front end surface 112a of the rear end member 112 has a sufficient area for the first spring seat 130 to abut when the plunger 106 moves rearward, and acts as a stopper that restricts the rearward movement of the plunger 106. To do.
  • the gripping bar 134 has a cylindrical shape divided into two by a slit, and can be held by the moderate frictional force by fitting with the gripped protrusion 28 of the hub 22 while being slightly elastically deformed.
  • the elastic piece 136 has a first protrusion 140 at the upper end of the tip and a second protrusion 142 slightly rearward.
  • the first spring seat 130 is provided with openings 144 on the left and right sides through which a part of the first connecting body 122 communicates.
  • the first spring seat 130 has a cup shape that opens rearward.
  • the front end member 118 has a mounting portion 150 on the distal end side where the casing 18 of the puncture needle tip 12 is detachably mounted.
  • the mounting portion 150 has a cylindrical shape with an outer surface that tapers slightly toward the tip, and slightly protrudes from the case main body 102.
  • the outer diameter of the front end portion of the mounting portion 150 is set so as to fit just into the fitting gap portion 41a of the skirt 41 and the inner diameter portion of the cylindrical portion 151 at the front end of the case body 102.
  • the thickness of the cylindrical portion 151 at the front end of the case body 102 is moderately thick, and acts as a receiving seat against which the rear end portion 41b of the skirt 41 abuts.
  • the cylindrical portion 151 is also referred to as a receiving seat 151.
  • a lumen portion of the mounting portion 150 is a mounting hole 153 in which the puncture needle tip 12 is mounted. In the initial state, the holding bar 134 of the plunger 106 is disposed in the mounting hole 153.
  • a portion of the front end member 118 other than the mounting portion 150 is inserted into the case main body 102, and the holding portion 152 that holds the puncture button 116 and the plunger 106 move to the rear end side by compressing the driving coil spring 108.
  • a trigger stopper 154 that sometimes engages the first protrusion 140 of the plunger 106.
  • the first connecting body 122 has a cylindrical body at the back and two arms 156 in the front.
  • the two arms 156 are inserted through the openings 144 of the plunger 106.
  • the second connection body 124 is a cylindrical body whose upper surface is open, and has an engagement piece 158 that engages with a slit of each arm 156 at the rear end. That is, the first connection body 122 and the second connection body 124 are integrally connected via the engagement piece 158, and the first connection body 122 and the second connection body 124 are integrally formed by pushing the pusher 120. Move to.
  • a rib 125 extending in the axial direction is formed below the outer peripheral portion of the second connection body 124.
  • an inclined surface 126 is formed at the tip of the rib 125 so as to be inclined so that the height of the rib 125 decreases toward the tip.
  • the slope 126 has a function as an abutting portion that abuts on a ring 6 described later when the puncture needle tip 12 is removed by an eject mechanism described later.
  • first connecting body 122 and the second connecting body 124 are only partially shown depending on their cross-sectional positions. It can be easily understood from FIG. 3 that the first connecting body 122 and the second connecting body 124 are integrated with the pusher 120.
  • the cylindrical portion behind the first connection body 122 is disposed so as to cover the rear side of the plunger 106
  • the second connection body 124 is disposed so as to cover the front side of the plunger 106
  • the plunger 106 is configured to cover the first connection body. It is possible to advance and retract in the axial direction inside 122 and the second connecting body 124.
  • the pusher 120, the first connecting body 122, and the second connecting body 124 move the casing 18 of the puncture needle tip 12 in the distal direction with respect to the case main body 102 and the front end member 118, thereby inserting the puncture needle tip 12 into the puncture device 1.
  • the main part of the eject mechanism to be removed from is constructed.
  • the second connecting member 124 constitutes an eject member that presses the proximal end portion of the casing 18 and moves the casing 18 in the distal direction.
  • a plunger 106 having a gripping bar 134 which is installed so as to be movable in the axial direction and to which the puncture needle 15 is detachably attached, and a driving member which is a biasing member that biases the plunger 106 in the distal direction.
  • the puncture needle includes a coil spring 108 and a trigger stopper 154 that engages with the first protrusion 140 that is an engaging portion of the plunger 106 biased in the distal direction by the driving coil spring 108 and prevents the plunger 106 from moving.
  • the main part of the puncture mechanism which performs the puncture operation which moves 15 at least from a firing preparation position to a puncture position is comprised.
  • the puncture button 116 performs an operation of activating the puncture mechanism and starting the puncture operation. That is, when the puncture button 116 is pressed, the engagement state between the first protrusion 140 of the plunger 106 and the trigger stopper 154 is released, and the puncture operation is started.
  • the front end member 118 is provided with a collet (pressure contact member) 5 and a ring (switching member) 6.
  • the collet 5 is installed inside the front end member 118 so as not to move in the axial direction.
  • the collet 5 is disposed on the outer periphery of the casing 18 in a state where the casing 18 of the puncture needle tip 12 is mounted on the mounting portion 150 of the front end member 118 (hereinafter also simply referred to as “mounted state”). It is in pressure contact and prevents the casing 18 from moving away from the mounting portion 150 (the direction in which the mounting of the casing 18 is released), that is, the movement of the casing 18 relative to the front end member 118 in the front end direction.
  • the collet 5 has an annular shape in the configuration shown in the drawing, and one portion thereof is cut along the axial direction. Moreover, the collet 5 has elasticity and its diameter can be changed.
  • the constituent material of the collet 5 is not particularly limited, and for example, various resin materials, various metal materials, and the like can be used.
  • the shape of the collet 5 is not limited to the shape shown in the figure, and may be, for example, a C shape with a part cut away, or a continuous ring without a cut part or a cut part. In the case of a continuous ring shape, the material of the collet 5 needs to have elasticity.
  • the ring 6 is installed inside the front end member 118 so as to be movable in the axial direction, and is movable in the axial direction with respect to the collet 5.
  • the ring 6 is located inside the collet 5, prevents the collet 5 from being pressed into contact with the casing 18, and the first state in which the collet 5 is not pressed into contact with the casing 18 and at least a part of the ring 6 retracts from the inside of the collet 5.
  • the pressure contact of the collet 5 to the casing 18 is allowed, and the collet 5 is switched to the second state in which the pressure collet 5 is pressed against the casing 18.
  • the entire ring 6 may be retracted from the inside of the collet 5, and a part of the ring 6 may be retracted from the inside of the collet 5. A part is assumed to be retracted from the inside of the collet 5.
  • the ring 6 has an annular shape, and two portions thereof are cut along the axial direction. That is, the ring 6 is composed of two semicircular members. Further, the ring 6 cannot be deformed in the inward direction when the two semicircular portions are combined.
  • the constituent material of the ring 6 is not particularly limited, and for example, various resin materials, various metal materials, various ceramics, and the like can be used.
  • the shape of the ring 6 is not limited to the shape shown in the figure.
  • an annular shape in which one portion is cut along the axial direction an annular shape in which three or more locations are cut along the axial direction, and a C-shape.
  • the shape may be a continuous ring without an axial cut portion or the like.
  • the collet 5 has an insertion part 51 into which the ring 6 is inserted and a pressure contact part 52 that is in pressure contact with the outer peripheral surface of the casing 18.
  • the pressure contact portion 52 is formed at the tip of the insertion portion 51 and protrudes toward the casing 18 in the mounted state.
  • the collet 5 in the first state, the collet 5 is expanded in diameter by inserting the ring 6 into the insertion portion 51, and in the second state, the diameter of the collet 5 is reduced by retracting at least part of the ring 6 from the insertion portion 51. Yes. That is, in the first state, the inner diameter of the press contact portion 52 is increased, and in the second state, the inner diameter of the press contact portion 52 is reduced.
  • the ring 6 has a large-diameter portion 61 and a small-diameter portion 62 having an inner diameter smaller than that of the large-diameter portion 61.
  • the small diameter portion 62 is formed on the proximal end side of the large diameter portion 61, and the outer diameter thereof is set smaller than that of the large diameter portion 61.
  • a stepped portion 64 is formed at the boundary between the large diameter portion 61 and the small diameter portion 62 in the inner peripheral portion of the ring 6.
  • the step portion 64 has a function as a contact portion that contacts the proximal end portion of the casing 18 when the puncture needle tip 12 is mounted.
  • an inclined surface 63 is formed at the tip of the large diameter portion 61 of the ring 6 so as to be inclined so that the outer diameter decreases toward the tip.
  • the slope 63 reduces the sliding resistance when the ring 6 moves inside the collet 5 and also has a function as a guide surface for guiding the ring 6.
  • the pressure contact portion 52 of the collet 5 is pressed against the outer peripheral surface of the casing 18 of the puncture needle tip 12 attached.
  • the press contact portion 52 tightens the casing 18 toward the center over the entire circumference.
  • the pressure contact force of the collet 5 to the casing 18 is larger than the fitting force between the cap 14 and the casing 18.
  • the initial state of the puncture device 1 is the first state (see FIG. 5A). That is, the ring 6 is inserted into the insertion portion 51 of the collet 5, and the outer diameter of the large-diameter portion 61 of the ring 6 is formed larger than the inner diameter of the insertion portion 51 of the collet 5, so that the collet 5 resists its elastic force. The diameter has been expanded. At this time, since the diameter of the press contact portion 52 is also enlarged, the inner diameter of the press contact portion 52 is larger than the outer shape of the casing 18.
  • the user first holds an unused puncture needle tip 12 to which the puncture device 1 and the cap 14 are attached, and punctures the puncture needle tip 12. It is inserted into the mounting hole 153 of the device 1 and pushed toward the rear end side. At this time, the gripping bar 134 of the plunger 106 is engaged with the gripped protrusion 28 of the hub 22. That is, the puncture needle 15 is attached to the plunger 106.
  • the fitting force between the peripheral surface 30 of the hub 22 and the rear annular bulging portion 40 of the casing 18 is stronger than the elastic force of the driving coil spring 108, and the fitting between the hub 22 and the casing 18 is released. There is no.
  • the plunger 106 reaches the preparation position for puncturing and is fixed by the trigger stopper 154. However, since the engagement between the hub 22 and the casing 18 is not released, it is insufficient as preparation for puncturing. At this stage, the skirt 41 does not cover the mounting portion 150. Further, the position of the puncture needle 15 at this time has reached the firing preparation position.
  • the plunger 106 is restricted from moving toward the rear end side by the front end face 112a.
  • the force is directly applied to the engaging portion between the peripheral surface 30 of the sliding support portion 26 in the hub 22 and the rear annular bulging portion 40 of the casing 18, and the engagement of the engaging portion is released. That is, the positions of the hub 22 and the plunger 106 do not change, but the casing 18 moves relatively rearward.
  • the mounting portion 150 is fitted into the fitting gap 41a (see FIG. 2) of the skirt 41, and the rear end portion 41b of the skirt 41 comes into contact with the receiving seat 151 and stops.
  • the mounting portion 150 is completely covered by the skirt 41 and is not visible from the outside.
  • the cap 14 is removed from the tip body 13 of the puncture needle tip 12 in the distal direction.
  • the collet 5 prevents the casing 18 from moving in the direction in which the casing 18 is detached from the mounting portion 150. Thereby, it can prevent that the unused puncture needle tip 12 will be in the state which cannot be used before use, or the state which a needle point does not fully protrude.
  • the tip of the chip body 13 is pressed against the skin of the measurer, for example, a finger, palm, arm, etc., and the puncture button 116 is pressed.
  • the first protrusion 140 is pushed down by the puncture button 116, the engagement state between the trigger stopper 154 and the first protrusion 140 is released, and the plunger 106 is driven elastically.
  • the puncture needle 15 is pushed out through the gripping bar 134.
  • the sliding ring 16 is pushed out simultaneously with the puncture needle 15 while being in contact with the minute step 24a, and excessive advancement is restricted by the inner circumferential step portion 34.
  • the needle 20 provided at the tip of the puncture needle 15 protrudes from the opening 42 and punctures the skin.
  • the position of the puncture needle 15 at this time is the puncture position.
  • the plunger 106 compresses the return coil spring 110 appropriately. Therefore, the plunger 106 is immediately pushed back backward by the elastic force of the return coil spring 110 returning to its original length.
  • a puncture operation is performed in which the puncture needle 15 is moved from the firing preparation position to the puncture position and then moved to the proximal end side.
  • the instantaneous protrusion length of the needle 20 connected to the plunger 106 is limited and adjusted by the small protrusion 138 of the plunger 106 coming into contact with the stepped portion 139.
  • the sliding ring 16 retreats integrally because it is engaged with the four elastic levers 24.
  • the front end of the front bulging portion 36 is retreated. It stops at the part and is left off from the elastic lever 24. Thereby, even if it tries re-use, the sliding ring 16 becomes obstructed and the needle point does not protrude from the opening 42.
  • a blood glucose level is measured by a predetermined blood glucose measuring device using blood flowing out from the punctured skin, and then the puncture needle tip 12 is removed from the puncture device 1.
  • the pusher 120 by pushing the pusher 120, the rear end surface of the casing 18 is pressed through the first connecting body 122 and the second connecting body 124, and the used puncture needle tip 12 is removed. be able to.
  • the removed puncture needle tip 12 is discarded by a predetermined method.
  • the distal end portion of the large-diameter portion 61 of the ring 6 is inserted into the insertion portion 51 of the collet 5, so that the ring 6 is securely inserted into the insertion portion 51. be able to.
  • the hub 22 does not move because it is initially held by the gripping bar 134.
  • the sliding ring 16 engages with the front bulging portion 36 and moves forward together with the casing 18, the sliding ring 16 is disengaged from the elastic lever 24 and is disengaged.
  • the elastic lever 24 is removed from the sliding ring 16, the elastic lever 24 is once elastically reduced in diameter, and then returns to its original diameter. Thereafter, the hub 22 also engages with the rear annular bulging portion 40 and moves forward integrally with the casing 18, and the puncture needle tip 12 is removed from the puncture device 1.
  • the elastic lever 24 is removed from the sliding ring 16 and is expanded in diameter, so that the sliding ring 16 moves forward of the elastic lever 24.
  • the sliding ring 16 serves as a movement restricting means for restricting the relative movement of the hub 22 to the front of the casing 18 at a predetermined position, and the needle 20 does not protrude from the tip surface.
  • the rear annular bulging portion 40 restricts the movement of the hub 22 in the rear, and the puncture needle 15 does not come out from the rear end side.
  • the gripping bar 134 engages with the gripped protrusion 28 of the hub 22 and pushes the plunger 106 backward, but the hub 22 engages with the rear annular bulging portion 40.
  • the plunger 106 cannot be moved to the rear sufficiently because it is disposed slightly forward after being released. Therefore, the first protrusion 140 does not engage with the trigger stopper 154, the driving coil spring 108 is not biased, and the puncturing operation is not performed even if the puncturing button 116 is pressed.
  • the front end of the elastic lever 24 comes into contact with the rear end of the sliding ring 16 and restricts the casing 18 from moving rearward relative to the hub 22. Even if it is pushed in, it only compresses the driving coil spring 108 a little, and when it is released, it is pushed back by the elastic force of the driving coil spring 108. As a result, the casing 18 cannot move sufficiently rearward, the rear end portion 41b of the skirt 41 does not contact the receiving seat 151, and a slight gap is generated, so that the mounting portion 150 is visually recognized from the side. . As a result, the user can easily recognize that the attached puncture needle tip 12 has been used.
  • the casing 18 of the attached puncture needle tip 12 is detached from the attachment portion 150 except when the puncture needle tip 12 is removed from the puncture device 1 by the eject mechanism. Can be prevented from moving to. Thereby, it can prevent that the used unused puncture needle tip 12 will be in the state which cannot be used before use, or the state where the needle tip does not sufficiently protrude from the tip opening.
  • the puncture device 1 is small, light and has a simple configuration and is easy to handle. Moreover, the puncture device 1 has a smooth bar shape and is suitable for carrying and storing.
  • the puncture apparatus of the present invention has been described based on the illustrated embodiment, but the present invention is not limited to this, and the configuration of each part is replaced with an arbitrary configuration having the same function. be able to. In addition, any other component may be added to the present invention.
  • the pressure contact member is pressed against the casing in a state where the casing of the puncture needle tip is mounted on the mounting portion. It is possible to prevent the needle tip casing from moving away from the mounting portion. This prevents the attached unused puncture needle tip from becoming unusable before use and preventing the needle tip from protruding from the tip opening of the puncture needle tip during use. it can. Therefore, it has industrial applicability.

Abstract

La présente invention concerne un dispositif de ponction (1), qui possède une pointe d'aiguille de ponction (12) montée amovible sur une partie d'extrémité distale, et qui est utilisé lorsqu'une ponction est faite dans une surface biologique. Ledit dispositif de ponction (1) comprend les éléments suivants : un collier (5), destiné à comprimer un boîtier (18) de la pointe d'aiguille de ponction (12) et à empêcher ledit boîtier (18) de se déplacer par rapport à un élément d'extrémité antérieure (118), dans une direction dans laquelle le boîtier (18) se sépare d'une partie de montage (150) de l'élément d'extrémité antérieure (118), ledit collier étant placé sur une partie périphérique externe du boîtier (18) dans un état dans lequel le boîtier (18) est monté sur la partie de montage (150) ; un anneau (6) permettant la commutation entre un premier état dans lequel le collier (5) ne comprime pas le boîtier (18) et un second état dans lequel le collier comprime le boîtier ; et un mécanisme d'expulsion destiné à retirer la pointe d'aiguille de ponction (12) du dispositif de ponction (1).
PCT/JP2012/057689 2011-03-30 2012-03-26 Dispositif de ponction WO2012133267A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2013507543A JP6014022B2 (ja) 2011-03-30 2012-03-26 穿刺装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011076668 2011-03-30
JP2011-076668 2011-03-30

Publications (1)

Publication Number Publication Date
WO2012133267A1 true WO2012133267A1 (fr) 2012-10-04

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JP (1) JP6014022B2 (fr)
WO (1) WO2012133267A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014146560A1 (fr) * 2013-03-18 2014-09-25 苏州施莱医疗器械有限公司 Stylet de prélèvement sanguin sûr amélioré
WO2014146558A1 (fr) * 2013-03-18 2014-09-25 苏州施莱医疗器械有限公司 Stylo d'échantillonnage de sang améliore sans danger

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007105617A1 (fr) * 2006-03-10 2007-09-20 Arkray, Inc. Dispositif a lancette
WO2009044594A1 (fr) * 2007-10-02 2009-04-09 Terumo Kabushiki Kaisha Ensemble de ponction
JP2010269169A (ja) * 2010-08-05 2010-12-02 Panasonic Corp 穿刺針カートリッジ

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007105617A1 (fr) * 2006-03-10 2007-09-20 Arkray, Inc. Dispositif a lancette
WO2009044594A1 (fr) * 2007-10-02 2009-04-09 Terumo Kabushiki Kaisha Ensemble de ponction
JP2010269169A (ja) * 2010-08-05 2010-12-02 Panasonic Corp 穿刺針カートリッジ

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014146560A1 (fr) * 2013-03-18 2014-09-25 苏州施莱医疗器械有限公司 Stylet de prélèvement sanguin sûr amélioré
WO2014146558A1 (fr) * 2013-03-18 2014-09-25 苏州施莱医疗器械有限公司 Stylo d'échantillonnage de sang améliore sans danger

Also Published As

Publication number Publication date
JPWO2012133267A1 (ja) 2014-07-28
JP6014022B2 (ja) 2016-10-25

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