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WO2011158669A1 - Lancette et dispositif de piqûre utilisant celle-ci - Google Patents

Lancette et dispositif de piqûre utilisant celle-ci Download PDF

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Publication number
WO2011158669A1
WO2011158669A1 PCT/JP2011/062804 JP2011062804W WO2011158669A1 WO 2011158669 A1 WO2011158669 A1 WO 2011158669A1 JP 2011062804 W JP2011062804 W JP 2011062804W WO 2011158669 A1 WO2011158669 A1 WO 2011158669A1
Authority
WO
WIPO (PCT)
Prior art keywords
lancet
puncture
puncture member
cap
tip
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2011/062804
Other languages
English (en)
Japanese (ja)
Inventor
秀明 佐伯
博和 居森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asahi Polyslider Co Ltd
Izumi Inc
Original Assignee
Izumi Cosmo Co Ltd
Asahi Polyslider Co Ltd
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 Izumi Cosmo Co Ltd, Asahi Polyslider Co Ltd filed Critical Izumi Cosmo Co Ltd
Publication of WO2011158669A1 publication Critical patent/WO2011158669A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
    • 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
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549—Protectors removed by rotational movement, e.g. torsion 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
    • A61B5/150374—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
    • A61B5/15109—Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's 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
    • A61B5/151—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
    • A61B5/15101—Details
    • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
    • A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides

Definitions

  • the present invention relates to a lancet. More particularly, the present invention relates to a lancet used for blood collection. The present invention also relates to a puncture device equipped with a lancet.
  • Such a puncture device is generally composed of a lancet (for example, Patent Document 1) provided with a puncture needle for piercing a predetermined part of the body and an injector.
  • the injector has a function of firing the lancet toward a predetermined location. In use, after a lancet is loaded into an injector, the lancet is fired using a plunger in the injector to puncture a predetermined location.
  • the lancet is used after the cap covering the needle tip is removed, but the needle tip may be bent when the cap is removed. Specifically, a load is applied to the needle tip due to a “triggering operation” performed to remove the cap, and the puncture needle may be bent or broken. Thus, when removing the lancet cap, the puncture needle may be damaged, and an improvement is desired.
  • FIG. 14 shows the appearance of the lancet assembly 100 ′
  • FIG. 15 shows the appearance of the injector 200 ′.
  • the lancet assembly 100 ' includes a lancet 101' and a protective cover 102 '.
  • the lancet 101 ′ includes a lancet body 104 ′, a lancet cap 106 ′, and a puncture needle 105 ′.
  • the metal puncture needle 105 ' exists across the resin lancet body 104' and the lancet cap 106 '.
  • the tip of the puncture needle 105 ' is covered with a lancet cap 106', and the lancet cap 106 'and the lancet body 104' are joined together via a weakening member 108 '.
  • the protective cover 102 ′ is provided so as to surround a part of the lancet body 104 ′.
  • An injector 200 'shown in FIG. 15 is a device that can be used in combination with the lancet assembly 100' to fire the lancet body with the tip of the puncture needle 105 'exposed.
  • the injector 200 ' has a "plunger 204' that can be engaged with the rear end of the lancet body and that fires the lancet body in the puncturing direction" (see FIG. 18).
  • the lancet assembly 100' is inserted from the front end opening 214 'of the injector 200'.
  • FIG. 20 shows the injector 200 ′ with the plunger retracted and the firing energy accumulated.
  • the lancet cap 106 ′ is removed to expose the tip of the puncture needle 105 ′.
  • the removal of the lancet cap 106 ' will be described as follows. As shown in FIGS. 16 and 17, the lancet body 104 ′ and the lancet cap 106 ′ are integrally coupled by a weakened portion 108 ′ positioned therebetween. Such weakening member 108 ′ can be broken by turning the lancet body 104 ′ and the lancet cap 106 ′ in the opposite directions around the puncture needle (FIG. 20 shows a mode of turning in the G direction. Thereby, the lancet cap 106 'can be removed.
  • the front end opening 214 'of the injector 200' is applied to a predetermined portion to be punctured, such as a fingertip, and then the press portion 542 'of the trigger member 514' is pushed (see FIG. 21).
  • the press portion 542 ' By pressing the press portion 542 ', the plunger 204' is fired forward (that is, the compressed spring is released), and puncture is performed by the puncture needle.
  • the puncture needle when puncturing with the launched puncture needle, it is desirable that the puncture needle surely strikes a predetermined location.
  • the puncture needle if the puncture needle is bent, the pain felt by the blood collection subject at the time of puncture is increased. Therefore, it is desired that the puncture needle is not bent and the puncture trajectory is as straight as possible.
  • the puncture needle may be bent during the lancet cap removal operation, and it is difficult to secure a straight puncture trajectory.
  • an object of the present invention is to provide a lancet in which the puncture needle is prevented from being damaged as much as possible when the lancet cap is removed.
  • Puncture member A lancet having a lancet body and a lancet cap
  • the puncture member extends across the lancet body and the lancet cap so that the tip of the puncture member is covered with the lancet cap, while the body of the puncture member is covered with the lancet body
  • a lancet is provided in which a body groove of the puncture member is provided with a circumferential groove or a circumferential projection, and the puncture member is rotatable about its axial direction.
  • the lancet according to the present invention is characterized in that the puncture member body extending within the lancet body is rotatable about its axial direction. This prevents damage to the puncture member when removing the lancet cap.
  • the distal end portion of the puncture member receives an external force, and the external force can rotate the puncture member as a whole about its axial center. That is, in the present invention, even though the body portion of the puncture member is provided so as to be enclosed by the lancet body, the body portion of the puncture member is not fixed to the lancet body. As a result, the puncture member can be suitably rotated when the lancet cap is removed, and the puncture member is prevented from being bent or broken.
  • the term “circumferential direction” substantially means an annular direction around the central axis (a line along the longitudinal direction) of the puncture member. Accordingly, the “circumferential groove” has a concave shape that is recessed along the annular direction on the outer peripheral surface of the puncture member body, while the “circumferential protrusion” is raised along the annular direction on the outer surface of the puncture member body. It has a convex shape.
  • the tip of the puncture member has a blade shape.
  • a “separation operation” ie, an operation to separate the lancet cap and the puncture member from each other
  • the “circumferential groove” or “circumferential protrusion” of the member functions suitably. Specifically, when the lancet cap is pulled away from the tip of the puncture member, the “circumferential groove” or “circumferential protrusion” functions as a stopper, and the trunk of the puncture member does not fall out of the lancet body.
  • the lancet body and the lancet cap are integrally formed, and the lancet cap and the lancet body are in a state of being connected to each other at their contact points.
  • the lancet cap and the lancet body are connected to each other via the “contact portion”. Therefore, the contact portion connecting the lancet cap and the lancet body is destroyed during the “rotating operation” or “detaching operation” of the lancet cap.
  • the contact portion is broken, the lancet cap can be separated from the lancet body, so that a state where the tip is exposed by the puncture member can be obtained.
  • no silicone oil or the like is provided between the puncture member body and the lancet body, and the puncture member body is in direct contact with the lancet body within the lancet body. . That is, when removing the lancet cap, the puncture member rotates with the puncture member body portion in direct contact with the lancet body. This means that in the lancet of the present invention, the puncture member can be rotated by overcoming the frictional resistance generated between the puncture member body and the lancet body.
  • the puncture device in the present invention, not only a lancet but also a puncture device using the lancet is provided. That is, a device for using the lancet for actual use is also provided.
  • the puncture device according to the present invention may have any form / configuration as long as it can fire the puncture member.
  • the puncture device of the present invention comprises a lancet, an injection spring, a trigger member, and a lancet holder that accommodates them.
  • the trigger member has a pair of arms provided inside the lancet holder,
  • the injection spring is attached to the lancet body, and the lancet body is locked to the arm part of the trigger member so that the compression state of the injection spring is maintained before puncturing,
  • the trigger member can be pushed into the lancet holder, and a pair of arm portions are bent by the pushing of the trigger member, and the locking of the lancet body is released.
  • a puncture device when the lock of the lancet body is released, the “fired lancet body having an exposed puncture member (tip portion)” is fired in the puncture direction due to the extension of the compressed injection spring. be able to.
  • a slope portion is provided on the inner wall of the lancet holder (especially the inner wall surface on the rear side of the holder), and the arm portion is slid and bent when the trigger member is pushed. It is supposed to be.
  • the term “deflection” here substantially means all kinds of modes in which the arm portion is displaced in the space in the lancet holder.
  • the arm part is bent means that the arm part is displaced outward in the lancet holder, in particular, the arm part is outward in a direction in which the tip parts of the pair of arm parts are separated from each other. It refers to the mode of opening.
  • the puncture member can rotate as the lancet cap is removed. Thereby, most of the force exerted on the puncture member at the time of removal is changed to the rotational force of the puncture member, so that damage to the puncture member such as bending or bending can be prevented. In particular, if the bending of the puncture member is prevented, the trajectory of the puncture member becomes substantially linear, and as a result, the pain felt by the puncture subject (that is, the blood sample) can be reduced. This is not limited to a specific theory, but is considered to be caused by a phenomenon that the puncture site of the blood sample is “squeezed out” by the puncture needle.
  • the puncture device provided with the lancet of the present invention, the “puncture” of the puncture member is prevented, and a puncture tip portion in a substantially constant exposed state can be obtained. Therefore, even if the users are different, the puncture trajectory of the puncture member becomes substantially constant, and variations among users are reduced.
  • FIG. 1 is an external view of a lancet according to the present invention.
  • FIG. 2 is a cross-sectional perspective view showing the internal structure of the lancet of the present invention.
  • FIG. 3 is a cross-sectional view and a plan transparent view showing the internal structure of the lancet of the present invention.
  • 4 (a) to 4 (d) are cross-sectional perspective views schematically showing changes with time of the lancet during the lancet cap removal operation.
  • FIG. 5 is a cross-sectional view showing the internal structure of the lancet according to the present invention (FIG. 5A: a puncture member provided with a circumferential groove, FIG. 5B: a puncture member provided with a circumferential projection. )
  • FIG. 5A a puncture member provided with a circumferential groove
  • FIG. 5B a puncture member provided with a circumferential projection.
  • FIG. 6A is an external view of the puncture device of the present invention
  • FIG. 6B is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention
  • FIG. 7 is a developed / exploded view schematically showing components of the puncture device of the present invention.
  • FIG. 8 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (before the cap removal operation).
  • FIG. 9 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (a state in which the cap is rotated about 90 ° during removal).
  • FIG. 10 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (a state where the cap is rotated by about 180 ° during removal).
  • FIG. 10 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (a state where the cap is rotated by about 180 ° during removal).
  • FIG. 11 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (a state in which the cap is pulled away from the puncture member during removal).
  • FIG. 12 is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention (a state immediately after the puncture member is fired).
  • 13 (a) to 13 (e) are partially cutaway perspective views of the puncture device schematically showing a series of changes from cap removal to puncture.
  • FIG. 14 is a perspective view showing the appearance of the lancet assembly.
  • FIG. 15 is a perspective view showing the appearance of the injector.
  • FIG. 16 is a perspective view showing the appearance of the lancet.
  • FIG. 17 is a perspective view when the lancet of FIG.
  • FIG. 16 is divided in half so that the inside of the lancet can be seen.
  • FIG. 18 is a perspective view showing a state before the lancet assembly is loaded into the injector.
  • FIG. 19 is a perspective view showing a state in which the lancet is gripped by the plunger tip by loading the lancet assembly.
  • FIG. 20 is a perspective view showing a state in which the lancet assembly is completely loaded and the plunger cannot be retracted.
  • FIG. 21 is a perspective view showing a state in which the lancet cap is removed and puncture is possible.
  • the “direction” used in this specification is defined as follows.
  • the direction in which the puncture member is fired during puncturing is the “front” direction, and the opposite direction is the “rear” direction. These directions are shown in the drawing.
  • the “puncture direction” substantially means the direction in which the puncture member moves toward the puncture site where blood is to be collected, and corresponds to the “forward direction”.
  • FIG. 1 is a perspective view showing the overall appearance of the lancet 100
  • FIG. 2 is a perspective view showing the internal structure of the lancet 100
  • FIG. 3 is a top view and a side view of the lancet 100.
  • the lancet 100 includes a lancet body 130, a lancet cap 170, and a puncture member 150 (see FIG. 2 and FIG. 3 in particular for the puncture member 150).
  • the puncture member 150 is a metal member, for example.
  • the lancet body 130 and the lancet cap 170 are, for example, resin members.
  • the puncture member 150 extends over the lancet body 130 and the lancet cap 170, and the tip portion 152 of the puncture member is covered with the lancet cap 170, while the trunk portion of the puncture member 156 is enclosed by the lancet body 130.
  • the lancet body 130 and the lancet cap 170 are integrally coupled through a few contact points 160.
  • the distal end portion 152 of the puncture member 150 preferably has a blade shape (in other words, the puncture member is preferably a “blood type”).
  • the “blade form” referred to in the present specification is referred to based on blade (sword), and substantially means a form in which an edge is sharpened by at least one surface.
  • the body 156 of the puncture member is provided in the lancet body 130, it is preferably provided so as to penetrate the lancet body 130 as shown in FIGS.
  • the term “inclusion” as used in the present specification refers to a mode in which the body portion 156 of the puncture member is provided so as to be wrapped in contact with the lancet body 130, but the body portion of the puncture member is particularly preferable. 156 points out the aspect extended so that the inside of a lancet body might be penetrated.
  • the body 156 of the puncture member 150 is provided so as to be wrapped in contact with the lancet body 130, but the body 156 is not fixed to the lancet body 130.
  • the body 156 of the puncture member 150 is provided in the lancet body 130, the body 156 and the lancet body 130 are not bonded to each other, and therefore, the body 156 of the puncture member 150 is externally applied. Can rotate around its axial direction.
  • the circumferential groove 158 In the body portion 156 of the puncture member, at least one circumferential groove 158 is provided.
  • the circumferential groove 158 has a concave shape that is recessed along the annular direction on the outer peripheral surface 156a of the puncture member body (if another expression is used, It can also be said that the portion 156 is provided with a “slit”.
  • the circumferential groove 158 is inherent in the lancet body 130 and is provided so as to be in direct contact with the lancet body portion.
  • the distal end portion 152 of the puncture member is a portion used for puncture when using the lancet. That is, it is a portion that pierces the puncture site of the person to be punctured.
  • the tip of the puncture member is covered with a lancet cap 170 in terms of hygiene and safety. Therefore, the term “coating” in the present specification substantially means a mode in which the tip 152 of the puncture member is covered with the lancet cap 170 so that there is no problem in terms of hygiene and safety. Yes.
  • the lancet cap 170 itself preferably has a form suitable for its removal. For example, as shown in FIG. 1, the tip portion 172 has a flat shape, and can be easily picked up by a fingertip and rotated.
  • the lancet 100 of the present invention is often used while being partially housed in a lancet holder described below, and therefore has a small size.
  • the overall length L 3, as shown in FIG. 2 may be 12.0 ⁇ 26.0 mm (e.g., about 18 mm).
  • the body portion 156 of the puncture member preferably has a cylindrical shape, and the diameter D is preferably 0.3 mm to 1.8 mm, more preferably 0.9 to 1.8 mm, and still more preferably 1. It is 4 to 1.6 mm (for example, about 1.5 mm) (see FIG. 2).
  • the material of the lancet body and the lancet cap may be one usually used as a lancet resin such as polyethylene or polypropylene, but is preferably at least selected from the group consisting of low density or high density polyethylene, polystyrene and elastomer. One or more soft resins.
  • the metal material of the puncture member 150 may be one normally employed as a lancet puncture needle, for example, stainless steel.
  • the main feature of the lancet of the present invention is that the puncture member is rotatable around its axial direction.
  • the puncture member can rotate about its axial direction.
  • the puncture member 150 can rotate as the lancet cap 170 is removed. That is, when the lancet cap 170 is rotated in the direction of the arrow A shown in the drawing, the puncture member 150 is similarly rotated along the direction of the arrow A. This is because the body 156 of the puncture member 150 is provided so as to be wrapped in contact with the lancet body 130, but the body 156 is not fixed to the lancet body 130.
  • the puncture member 150 rotates in accordance with the cutting operation when the lancet cap 170 is removed, damage to the puncture member such as bending or bending of the distal end portion is prevented.
  • a twisting force is applied to the lancet cap along with the cutting operation, but the puncture member present therein resists As a result, a force against the twist is generated, and the lancet cap is eventually broken.
  • a force for rotational movement acts on the distal end portion 152 of the puncture member along with the cutting operation, while a force against the force acts on the trunk portion 156 of the puncture member.
  • the distal end portion 152 of the puncture member is bent, and when the force exceeds a certain threshold value, the distal end portion 152 is also broken.
  • the tip portion 152 of the puncture member has a blade shape
  • the force applied to the tip portion 152 of the puncture member in association with the cutting operation increases, and the “break” of the lancet cap or the tip portion 152 of the puncture member It is easy to cause “bending” and “breaking”.
  • the rotational force at the time of cutting is preferably used in reverse, so that “break of the lancet cap” or “bending of the puncture member” Is preventing.
  • the pulling operation is performed in addition to the rotation operation of the cap 170.
  • the body portion of the puncture member does not come out of the lancet body 130. That is, the body 156 of the puncture member 150 is prevented from being removed from the lancet body 130 even though the body 156 is not fixed to the lancet body 130.
  • the circumferential groove 158 is inherent in the lancet body 130 as described above, the concave shape of the circumferential groove 158 provides “resistance”, and the body portion 156 of the puncture member 150 is prevented from being detached. That is, when the lancet cap is pulled away from the distal end portion of the puncture member, the circumferential groove functions as a stopper, so that the puncture member body portion does not fall out of the lancet body.
  • the form is not limited to the “groove form”, and other forms are possible.
  • a “flange shape” may be used.
  • a circumferential protrusion 158 ' may be provided on the body of the puncture member. That is, the convex part which protruded along the annular direction may be provided in the outer peripheral surface 156a of the puncture member trunk
  • the circumferential protrusion 158 ′ and the lancet body 130 are engaged with each other, the circumferential protrusion 158 ′ preferably functions as a stopper when the lancet cap is pulled away from the tip of the puncture member. As a result, the puncture member body does not fall out of the lancet body.
  • the dimensions of the circumferential groove 158 or the circumferential protrusion 158 ′ are not particularly limited as long as they function as a stopper in the operation of pulling the lancet cap.
  • the width dimension wa may be 0.2 to 3.0 mm (for example, about 1 mm)
  • the depth dimension da is 0.1 to 3.0 mm. It may be 1.0 mm (eg about 0.5 mm).
  • the width dimension wb may be 0.2 to 3.0 mm (for example, about 1 mm), and the height dimension hb is 0.
  • the depth dimension da of the circumferential groove 158 since the strength of the puncture member body portion decreases if it is increased more than necessary, at least 25% of the diameter dimension D of the body portion does not exceed, that is, da ⁇ It is preferably D ⁇ 0.25.
  • the circumferential groove 158 or the circumferential projection 158 ′ not only functions as a stopper when the lancet cap is pulled apart, but also has an effect of assisting the rotational movement of the puncture member.
  • This can be easily understood by assuming a puncture member in which the circumferential groove 158 and the circumferential protrusion 158 'are not provided. In actual rotation operation of the lancet cap, some force is generated to separate the lancet cap and the puncture member from each other. However, in the case where the circumferential groove 158 and the circumferential protrusion 158 ′ are not provided, FIG.
  • the circumferential groove 158 or the circumferential protrusion 158 ' has an advantageous effect not only when the lancet cap is removed but also when puncturing after removing the cap. Specifically, when the circumferential groove 158 and the circumferential projection 158 ′ are provided, the puncture member is prevented from being detached, so that the puncture member 150 remains at the site of the person to be punctured after the puncture. Is prevented. In addition, since the relative positional relationship between puncture member body 156 and lancet body 130 does not shift, a predetermined puncture depth can be reliably realized during puncture.
  • the puncture member rotates around its axial direction without causing a relative positional relationship between the body 156 and the lancet body 130 due to the circumferential groove 158 or the circumferential projection 158 ′. Since it can move, the vibration at the time of puncture can be reduced. That is, at the time of puncturing, the tip of the puncture member may vibrate so that it undulates. At that time, the rotational motion of the puncture member can absorb the undulating energy. Therefore, it can be said that the circumferential groove 158 or the circumferential protrusion 158 'indirectly contributes to the improvement of the linearity of the puncture trajectory at the time of puncture.
  • FIGS. 4A to 4D Change over time when removing the lancet cap
  • FIGS. 4A to 4D changes with time when the lancet cap is removed will be described.
  • 4A to 4D show changes over time of the lancet 100 in the order of the numbers.
  • FIG. 4A shows a state before the lancet cap removal operation. As shown in the drawing, the tip 152 of the puncture member 150 is covered with the lancet cap 170 in the state before the puncture. In the state before puncturing, the lancet cap 170 and the lancet body 130 are coupled to each other via the contact portion 160.
  • FIG. 4B shows a mode at the time when the lancet cap removal operation is started.
  • the “gripping operation” is performed by grasping the grip 172 of the lancet cap with a fingertip or the like. Specifically, the lancet cap is rotated in the direction A shown in the figure while fixing the lancet body 130. As a result, a rotating force is similarly applied to the distal end portion 152 of the puncture member existing in the lancet cap, and as a result, the puncture member 150 is entirely rotated about its axial center. By performing such rotation, the puncture member is prevented from being bent or broken when the cap is removed. When the lancet cap is rotated to some extent, the contact portion 160 between the lancet cap 170 and the lancet body 130 is broken (see, for example, FIG. 4C).
  • the lancet 100 according to the present invention can be manufactured by so-called insert molding in which the puncture member 150 is inserted into a mold and a resin raw material is molded.
  • the contact portion ie, “bridge portion” that connects the lancet cap 170 and the lancet body 130 to each other can be manufactured together with this insert molding. Therefore, the “contact portion” can be formed from the same resin raw material as the lancet cap 170 and the lancet body 130.
  • Such a “contact part” is required to be destroyed when the cap is removed, and therefore the contact part can also be referred to as a “weakened part” or an “easy to break part”.
  • the contact portion may be cut in advance, or may not have the contact portion, and a “lancet body with the tip portion 152 exposed” can be obtained when the “lance operation” of the lancet cap is performed. If you can, there is no problem.
  • the insert molding is performed with the puncture member 150 fixed.
  • insert molding is performed by supporting the puncture member 150 from both sides. Therefore, in the lancet obtained by being supported from both sides, the trace remains, and, for example, depressions (134a, 134b) as shown in FIGS. 5A and 5B are formed.
  • the “circumferential groove 158” of the puncture member used for insert molding can be formed by general machining such as cutting, turning, forging, rolling, pressing, or laser processing.
  • the “circumferential protrusion 158 ′” of the puncture member can be formed by general machining such as cutting, turning, forging, rolling, pressing, or laser processing.
  • the sterilization treatment of the distal end portion 152 of the puncture member can be performed by performing ⁇ -ray irradiation or the like while the lancet cap is covered.
  • the puncture device of the present invention has the lancet described above.
  • the puncture device of the present invention may have any form as long as it can fire the lancet puncture member 150 at the time of puncture.
  • the puncture device 500 may have a form and configuration as shown in FIGS. 6 and 7. 6 shows an external view (FIG. 6 (a)) and a partially transparent view (FIG. 6 (b)) of the lancet puncture device 500 of the present invention, and FIG. The figure is shown.
  • the lancet puncture device 500 according to the present invention is mainly composed of “lancet 100”, “lancet holder 200”, “injection spring 300” and “trigger member 400”. .
  • the lancet puncture device 500 of the present invention has a structure in which the lancet 100, the injection spring 300, and the trigger member 400 are housed in the lancet holder 200.
  • the injection spring 300 is provided between the rear end 133 of the lancet and the rear end portion 400a of the trigger member. More specifically, as shown in FIGS. 6B and 7, in the lancet holder 200, one end of the injection spring 300 is attached to the rear end 133 of the lancet 100. The other end of the injection spring 300 is attached to the “fitting portion 450 of the trigger member 400”.
  • the lancet body 130 is locked to the arm portion 420 of the trigger member 400 so that the injection spring 300 attached to the lancet body 130 is in a compressed state. It is in a state (see, for example, FIG. 6B).
  • One of the features of the lancet puncture device of the present invention is substantially composed of four members such as a “lancet”, a “trigger member”, a “lancet holder”, and an “injection spring”. It is simple and the overall size is relatively small.
  • the lancet holder 200 has, for example, a rectangular tube shape as a whole.
  • the lancet holder 200 partially accommodates the lancet described above and is as small as the lancet.
  • the shape of the lancet holder 200 is not necessarily limited to the rectangular tube shape, and may be, for example, a cylindrical shape.
  • the lancet holder 200 may be formed of any kind of resin material as long as it is a resin material used for a general lancet.
  • the inner wall surface of the lancet holder 200 is provided with a “slope portion” that functions in cooperation with the arm portion 420 of the trigger member.
  • This “slope portion” is indicated by reference numeral 250 (“shaded portion”) in FIGS. 12 and 13 (e), for example.
  • the slope portion 250 is a portion where the arm portion 420 is rubbed when the trigger member is pushed, and realizes the bending of the arm portion during the puncturing operation.
  • the trigger member 400 used in the lancet puncture device 500 includes a pair of arm portions 420.
  • a trigger member 400 may be formed from the same resin as the lancet 100 (for example, polyethylene, polypropylene, etc.).
  • the arm portion 420 preferably has flexibility as a whole.
  • the distal end portions of the paired arm portions that is, the free end portions 420a bend outward in a direction away from each other.
  • the arm portion 420 functions favorably so that the lancet body is unlocked.
  • the tip part 420a of a pair of arm part 420 is provided with the slope surface 420b which can contact
  • the slope surface 420b preferably has a shape complementary to the slope portion 250 of the lancet holder 200, so that the slope surface 420b of the arm portion 420 is pushed into the slope portion 250 of the holder 200 when the trigger member is pushed.
  • the top can be rubbed suitably.
  • the pair of arm portions 420 of the trigger member is provided with a locked portion to which the lancet body 130 is locked before puncturing. Specifically, as shown in FIG. 6B, a raised-shaped locked portion 421 is formed on the inner side surfaces of the pair of arm portions 420.
  • the injection spring 300 is used for “injection” or “firing” as the name suggests.
  • the ejection spring 300 is a spring that applies a propulsive force for firing or puncturing to the puncture member 150, particularly “lancet body including an exposed puncture member”.
  • the injection spring 300 is provided in a compressed state between the “spring mounting portion 450 of the trigger member 400” and the “lancet 100” (see FIG. 6B).
  • the injection spring 300 is preferably made of metal, for example, a metal coil spring.
  • the size of the injection spring 300 is not particularly limited as long as it is accommodated in the lancet holder.
  • FIGS. 13A to 13E collectively show a series of changes with time.
  • the puncture device 500 of the present invention before puncturing is shown in FIGS. 8 and 13 (a).
  • a lancet cap 170 is provided so as to cover the distal end portion 152 of the puncturing member, and the injection spring 300 is provided between the “rear end portion 400a of the trigger member” and the “lancet 100”.
  • the injection spring 300 is provided between the “rear end portion 400a of the trigger member” and the “lancet 100”.
  • a compressed state In a compressed state.
  • the lancet cap 170 When puncturing, the lancet cap 170 is removed from the lancet. To remove the lancet cap 170, a “saw removal operation” of the lancet cap 170 is performed. Specifically, as shown in FIGS. 9 and 13B, first, the lancet cap 170 (particularly the gripping portion 172) is rotated to destroy the “contact portion between the lancet body 130 and the lancet cap 170”. In other words, an operation is performed in which the lancet holder 200 is pinched and held from the outside with one hand and the grip 172 of the lancet cap 170 is twisted with the finger of the other hand.
  • the distal end 152 of the puncture member inherent in the lancet cap rotates in the same manner as the lancet cap rotates, and the puncture member trunk 156 integrated with the distal end 152 also rotates in the same manner. become. That is, as the lancet cap 170 rotates, the puncture member 150 as a whole rotates about its axial direction.
  • the contact portion 160 between the lancet cap 170 and the lancet body 130 is broken.
  • the contact portion 160 is broken.
  • the trigger part 400 is held in the holder. Push in toward the inside.
  • the trigger portion can be pushed in by holding the lancet holder 200 and pressing the puncture device toward the “predetermined site to be punctured” (ie, “pressing a seal”). Can do).
  • the tip portion 420a particularly, the arm surface of 420b
  • the arm portion of the trigger member rubs the slope portion 250 of the holder, so that the arm portion is bent outward as a whole.
  • the contact state between the locking portion of the lancet body and the locked portion of the arm portion is released (that is, the locking state of the lancet body is released).
  • the lancet body is unlocked, the compressed injection spring 300 is extended, and the lancet body 130 having the exposed puncture member is fired in the puncture direction.
  • the lancet body 130 moves in the puncturing direction, and the puncture member 150 is exposed from the opening end 403 of the trigger member.
  • a predetermined part applied to the opening end 403 is punctured. Is done.
  • the puncturing member 150 is quickly retracted.
  • the lancet body 130 with an exposed puncture member is attached to the injection spring 300, the lancet body 130 is retracted in a form pulled by the injection spring, and finally The puncture member 150 is housed in the lancet holder 200.
  • the two-chamfered blade-type puncture member is exemplified, but the present invention is not necessarily limited thereto, and the blade-type puncture member may have another chamfering form such as three-chamfering.
  • the tip of the puncture member can be applied to the tip of the puncture member as long as the rotational force can be exerted on the tip of the puncture member.
  • the blade-type puncture member does not have to be provided, and the puncture tip portion may have a “needle shape”.
  • the circumferential groove 158 or the circumferential projection 158 ' is continuously formed as shown in FIG. 5, for example.
  • the circumferential groove 158 or the circumferential protrusion 158 ′ is formed intermittently if it functions as a “stopper” without hindering the rotation of the puncture member in the axial direction when the lancet cap is removed.
  • the circumferential groove 158 may have a concave shape that is intermittently depressed in the annular direction on the outer peripheral surface of the puncture member body, and the circumferential protrusion 158 ′ is formed on the outer surface of the puncture member body. And may have a convex shape raised intermittently in the annular direction.
  • the puncture member may be exposed by partially notching the lancet body so that the puncture member rotates easily when the lancet cap is removed. That is, in order to effectively reduce the frictional resistance that the puncture member can receive during rotation, the area of the puncture member body portion that is in direct contact with the lancet body portion may be appropriately reduced.
  • the depressions (134a, 134b) generated during the insert molding partially expose the puncture member, and thus can effectively contribute to the rotation of the puncture member (FIGS. 5A and 5B). reference).
  • the present invention as described above includes the following aspects: 1st aspect: It is a lancet which has a puncture member, a lancet body, and a lancet cap, The puncture member extends across the lancet body and the lancet cap so that the tip of the puncture member is covered with the lancet cap, while the body of the puncture member is covered with the lancet body, A lancet characterized in that a circumferential groove or a circumferential projection is provided in a body portion of the puncture member, and the puncture member is rotatable about its axial direction.
  • Second aspect The lancet according to the first aspect, wherein the tip of the puncture member has a blade shape.
  • a lancet characterized by Fourth aspect The puncture member according to any one of the first to third aspects, wherein the lancet cap is removed when the lancet body and the circumferential groove or the circumferential protrusion are engaged with each other.
  • the lancet is characterized by the fact that the torso part does not come off the lancet body.
  • Fifth aspect The lancet according to any one of the first to fourth aspects, wherein the body portion of the puncture member is in direct contact with the lancet body in the lancet body.
  • a puncture device comprising the lancet according to any one of the first to fifth aspects.
  • the puncture member When the lancet of the present invention is used, the puncture member can be prevented from bending or breaking when the cap is removed, so that the puncture trajectory of the puncture member can be improved and pain during puncture can be reduced. Therefore, such a lancet and a puncture device using the lancet can be suitably used for blood collection of a diabetic patient, and can also be used in various applications that require blood collection.

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Abstract

La présente invention concerne une lancette qui est formée avec un élément de piqûre, un corps de lancette et un capuchon de lancette. La lancette est caractérisée en ce que la pointe de l'élément de piqûre est recouverte par le capuchon de lancette dans une direction, l'élément de piqûre s'étend le long du corps de lancette et le capuchon de lancette de telle manière que le corps de l'élément de piqûre soit enfermé dans le corps de lancette, une rainure circonférentielle ou une saillie circonférentielle est disposée sur le corps de l'élément de piqûre et l'élément de piqûre peut tourner autour de l'axe d'élément de piqûre.
PCT/JP2011/062804 2010-06-17 2011-06-03 Lancette et dispositif de piqûre utilisant celle-ci Ceased WO2011158669A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2010-138174 2010-06-17
JP2010138174 2010-06-17

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WO2011158669A1 true WO2011158669A1 (fr) 2011-12-22

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2486852A4 (fr) * 2009-10-07 2013-02-20 Asahi Polyslider Co Ltd Dispositif d'incision
GB2498772A (en) * 2012-01-27 2013-07-31 Owen Mumford Ltd Lancing device moving lancet needle in longitudinal and lateral directions, lancet needle and lancing device with anti-recocking means
JP2014047823A (ja) * 2012-08-30 2014-03-17 Ntn Corp 油圧式オートテンショナ
WO2014200924A1 (fr) * 2013-06-10 2014-12-18 Facet Technologies, Llc Aiguille de lancette avec encoche d'alignement et de rétention
WO2015159845A1 (fr) * 2014-04-16 2015-10-22 株式会社旭ポリスライダー Lancette

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008017877A (ja) * 2006-07-10 2008-01-31 Nippon Valqua Ind Ltd 穿刺体および穿刺体を用いた穿刺装置ならびに血糖値測定装置

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008017877A (ja) * 2006-07-10 2008-01-31 Nippon Valqua Ind Ltd 穿刺体および穿刺体を用いた穿刺装置ならびに血糖値測定装置

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9693712B2 (en) 2009-10-07 2017-07-04 Asahi Polyslider Company, Limited Lancet pricking device
US9044177B2 (en) 2009-10-07 2015-06-02 Asahi Polyslider Company, Limited Lancet pricking device
US9282919B2 (en) 2009-10-07 2016-03-15 Asahi Polyslider Company, Limited Lancet pricking device
EP2486852A4 (fr) * 2009-10-07 2013-02-20 Asahi Polyslider Co Ltd Dispositif d'incision
GB2498772A (en) * 2012-01-27 2013-07-31 Owen Mumford Ltd Lancing device moving lancet needle in longitudinal and lateral directions, lancet needle and lancing device with anti-recocking means
WO2013110953A1 (fr) * 2012-01-27 2013-08-01 Owen Mumford Limited Dispositif de perçage
JP2015508316A (ja) * 2012-01-27 2015-03-19 オウエン マンフォード リミティド 穿刺デバイス
US10105079B2 (en) 2012-01-27 2018-10-23 Owen Mumford Limited Lancing device
JP2014047823A (ja) * 2012-08-30 2014-03-17 Ntn Corp 油圧式オートテンショナ
WO2014200924A1 (fr) * 2013-06-10 2014-12-18 Facet Technologies, Llc Aiguille de lancette avec encoche d'alignement et de rétention
US10631770B2 (en) 2013-06-10 2020-04-28 Facet Technologies, Llc Lancet needle with alignment and retention notch
US12433519B2 (en) 2013-06-10 2025-10-07 Facet Technologies, Llc Lancet needle with alignment and retention notch
WO2015159845A1 (fr) * 2014-04-16 2015-10-22 株式会社旭ポリスライダー Lancette

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