WO2011158669A1 - Lancet and puncture device using same - Google Patents

Lancet and puncture device using same 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
Application number
PCT/JP2011/062804
Other languages
French (fr)
Japanese (ja)
Inventor
秀明 佐伯
博和 居森
Original Assignee
株式会社旭ポリスライダー
泉株式会社
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 株式会社旭ポリスライダー, 泉株式会社 filed Critical 株式会社旭ポリスライダー
Publication of WO2011158669A1 publication Critical patent/WO2011158669A1/en

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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

The disclosed lancet is formed with a puncture member, a lancet body and a lancet cap. The lancet is characterised in that the tip of the puncture member is covered by the lancet cap in one direction, the puncture member extends along the lancet body and the lancet cap in such a manner that the body of the puncture member is enclosed in the lancet body, a circumferential groove or a circumferential protrusion are provided to the body of the puncture member and the puncture member can rotate about the puncture member axis.

Description

ランセットおよびそれを用いた穿刺デバイスLancet and puncture device using the same
　本発明はランセットに関する。より詳細には、本発明は、血液採取に供されるランセットに関する。また、本発明はランセットを搭載した穿刺デバイスにも関する。 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.
　糖尿病患者の血糖値の測定には、その患者の血液を採取する必要がある。採取される血液は少量でよい。従って、少量の血液を採取する穿刺デバイスが使用されることになる。かかる穿刺デバイスは、身体の所定箇所を突くための穿刺針が設けられたランセット（例えば特許文献１）およびインジェクターから一般に構成されている。インジェクターは、ランセットを所定箇所に向かって発射させる機能を有している。使用に際しては、ランセットをインジェクターに装填した後、インジェクター内のプランジャーを用いてランセットを発射させることによって、所定箇所を穿刺している。 Measure blood glucose levels of diabetic patients by collecting their blood. A small amount of blood may be collected. Therefore, a puncture device that collects a small amount of blood is used. 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.
　糖尿病患者の血液採取に用いる穿刺デバイスとしては、衛生面や安全性の点だけでなく、使用時における穿刺特性の点でも望ましいものが求められる。特に、穿刺針が曲がっていると、所望箇所を確実に穿刺できないだけでなく、被採血者が穿刺時に感じる痛みが増すことになる。 As a puncture device used for blood collection of diabetic patients, not only hygiene and safety but also desirable puncture characteristics at the time of use are required. In particular, when the puncture needle is bent, not only can a desired location be reliably not punctured, but also the pain felt by the blood sample during puncture increases.
　これに関して、ランセットは、針先を覆っているキャップを取り外してから使用されるものであるが、そのキャップの取り外しに際して針先が曲がってしまうことがあった。具体的には、キャップを取り外すために行う“もぎり操作”に起因して針先に負荷がかかり、穿刺針が曲がったり、折れたりすることがあった。このように、ランセットキャップの取外しに際しては穿刺針が損傷を受けることがあり、改善が望まれている。 In this regard, 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.
米国特許明細書第５３８５５７１号公報US Pat. No. 5,385,571
　本出願人は、これまでに以下で説明する穿刺デバイスについて発明を為しており、その発明に関する出願を行っている（国際特許公開第２００７／０１８２１５号公報、出願日：２００６年８月８日、発明の名称：「穿刺デバイスならびにそれを構成するランセットアッセンブリおよびインジェクターアッセンブリ」）。図面を参照しながら、この発明に係るランセットアッセンブリおよびインジェクターアッセンブリを簡潔に説明する（以後では、「インジェクターアッセンブリ」を「インジェクター」とも称して説明する）。図１４にランセットアッセンブリ１００’の外観を示すと共に、図１５にインジェクター２００’の外観を示す。図１４に示すように、ランセットアッセンブリ１００’は、ランセット１０１’および保護カバー１０２’から構成されている。図１６および図１７に示すように、ランセット１０１’は、ランセットボディ１０４’、ランセットキャップ１０６’および穿刺針１０５’を有して成る。金属製の穿刺針１０５’は、樹脂製のランセットボディ１０４’およびランセットキャップ１０６’にまたがって存在している。穿刺針１０５’の先端部は、ランセットキャップ１０６’によってカバーされていると共に、ランセットキャップ１０６’とランセットボディ１０４’とが弱化部材１０８’を介して一体に結合している。図１４および図１７に示すように、保護カバー１０２’は、ランセットボディ１０４’の一部を包囲するように設けられている。このようなランセットアッセンブリ１００’は、インジェクター２００’に装填された後でランセットキャップ１０６’が取り外される。これにより、穿刺針１０５’の先端部が露出するので、ランセットを穿刺に供すことができる。 The present applicant has invented the puncture device described below, and has filed an application relating to the invention (International Patent Publication No. 2007/018215, filing date: August 8, 2006) The title of the invention: “Puncture device and lancet assembly and injector assembly constituting it”). A lancet assembly and an injector assembly according to the present invention will be briefly described with reference to the drawings (hereinafter, “injector assembly” will also be referred to as “injector”). FIG. 14 shows the appearance of the lancet assembly 100 ′, and FIG. 15 shows the appearance of the injector 200 ′. As shown in FIG. 14, the lancet assembly 100 'includes a lancet 101' and a protective cover 102 '. As shown in FIGS. 16 and 17, 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 '. As shown in FIGS. 14 and 17, the protective cover 102 ′ is provided so as to surround a part of the lancet body 104 ′. After such a lancet assembly 100 ′ is loaded into the injector 200 ′, the lancet cap 106 ′ is removed. As a result, the tip of the puncture needle 105 'is exposed, so that the lancet can be used for puncture.
　図１５に示すインジェクター２００’は、ランセットアッセンブリ１００’と組み合わせて用いて、穿刺針１０５’の先端が露出した状態のランセットボディを発射することができるデバイスである。インジェクター２００’は、「ランセットボディの後端部と係合でき、ランセットボディを穿刺方向に発射させるプランジャー２０４’」を有して成る（図１８参照）。インジェクター２００’に装填するに際しては、図１８に示すように、ランセットアッセンブリ１００’をインジェクター２００’の前端開口部２１４’から挿入する。ある程度挿入すると、図１９に示すように、ランセットアッセンブリ１００’の後方部分１１６’が、プランジャー２０４’の先端部２６４’, ２６６’によって把持される。引き続いて挿入を継続すると、プランジャー２０４’が後退して発射エネルギーが蓄積される。つまり、プランジャー２０４’の後退により、プランジャー２０４’に設けられたバネ（図示せず）が圧縮する（従って、その圧縮状態を解放すると、プランジャーが前方へと瞬時に移動し、ランセットが発射されることになる）。プランジャーが後退して発射エネルギーが蓄積された状態のインジェクター２００’を図２０に示す。 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). When loading into the injector 200 ', as shown in FIG. 18, the lancet assembly 100' is inserted from the front end opening 214 'of the injector 200'. When inserted to some extent, the rear portion 116 ′ of the lancet assembly 100 ′ is gripped by the tip 264 ′ and the flange 266 ′ of the plunger 204 ′ as shown in FIG. 19. As the insertion continues, the plunger 204 'retracts and the firing energy is accumulated. That is, the spring (not shown) provided in the plunger 204 ′ is compressed by the retraction of the plunger 204 ′ (therefore, when the compressed state is released, the plunger is instantaneously moved forward, and the lancet is Will be fired). FIG. 20 shows the injector 200 ′ with the plunger retracted and the firing energy accumulated.
　ランセットアッセンブリ１００’のインジェクター２００’への装填が完了すると、ランセットキャップ１０６’を取り外して穿刺針１０５’の先端を露出させる。ランセットキャップ１０６’の取外しについて説明すると次のようになる。図１６および図１７に示すように、ランセットボディ１０４’とランセットキャップ１０６’とは、その間に位置する弱化部分１０８’によって一体に結合されている。かかる弱化部材１０８’は、ランセットボディ１０４’とランセットキャップ１０６’とを穿刺針の周囲で相対的に反対方向に回すことによって破壊することができ（図２０にはＧ方向に回す態様が示されている）、それによって、ランセットキャップ１０６’を取り外すことができる。 When the loading of the lancet assembly 100 ′ into the injector 200 ′ is completed, 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.
　穿刺に際しては、例えば指先などの穿刺すべき所定の部位に対してインジェクター２００’の前端開口部２１４’をあてがった後、トリガー部材５１４’のプレス部分５４２’を押す（図２１参照）。かかるプレス部分５４２’の押し込みによって、プランジャー２０４’が前方に向かって発射され（つまり、圧縮されていたバネが解放され）、穿刺針によって穿刺が行われることになる。 At the time of puncturing, for example, 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). 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.
　ここで、発射された穿刺針による穿刺に際しては、穿刺針が確実に所定箇所を突くことが望まれる。特に、穿刺針が曲がっていたりすると、穿刺時に被採血者が感じる痛みが増すことになるので、穿刺針は曲がっておらず穿刺軌道ができるだけ直線的となるものが望まれる。しかしながら、実際には、ランセットキャップの取り外し操作に際して、穿刺針が曲がってしまうことがあり、直線的な穿刺軌道を確保することが難しい現状がある。 Here, when puncturing with the launched puncture needle, it is desirable that the puncture needle surely strikes a predetermined location. In particular, 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. However, in actuality, the puncture needle may be bent during the lancet cap removal operation, and it is difficult to secure a straight puncture trajectory.
　本発明は、上記事情に鑑みて為されたものである。つまり、本発明の課題は、ランセットキャップの取外し時における穿刺針の損傷ができる限り防止されたランセットを提供することである。 The present invention has been made in view of the above circumstances. That is, 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.
　上記課題を解決するため、本発明では、
　穿刺部材、
　ランセットボディ、および
　ランセットキャップ
を有して成るランセットであって、
　穿刺部材の先端部がランセットキャップで被覆される一方、穿刺部材の胴部がランセットボディで包接されるように、穿刺部材がランセットボディおよびランセットキャップにまたがって延在しており、
　穿刺部材の胴部には周方向溝または周方向突起が設けられており、穿刺部材がその軸方向を中心に回転自在となっていることを特徴とする、ランセットが提供される。 In order to solve the above problems, in the present invention,
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.
　本発明に係るランセットは、ランセットボディ内にて延在する穿刺部材胴部が、その軸方向を中心に回転可能となっていることを特徴の１つとしている。これにより、ランセットキャップの取り外し時における穿刺部材の損傷が防止される。特に、穿刺部材の先端部からランセットキャップを取り外すに際しては、穿刺部材の先端部が外力を受けることになるが、その外力によって穿刺部材がその軸方向中心に全体的に回転することができる。つまり、本発明では、穿刺部材の胴部がランセットボディに包接されるように設けられているといえども、その穿刺部材の胴部がランセットボディに対して固定されていない。その結果、ランセットキャップの取り外し時に穿刺部材が好適に回転することができ、穿刺部材の曲がり・折れなどが防止される。 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. In particular, when removing the lancet cap from the distal end portion of the puncture member, 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.
　本明細書において用いる「周方向」という用語は、穿刺部材の中央軸線（長手方向に沿った線）周りの環状方向を実質的に意味している。従って、「周方向溝」は穿刺部材胴部の外周面において環状方向に沿って窪んだ凹部形態を有する一方、「周方向突起」は穿刺部材胴部の外周面において環状方向に沿って隆起する凸部形態を有している。 As used herein, 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.
　ある好適な態様では、穿刺部材の先端部がブレード形態を有している。これにより、ランセットキャップを“もぎる”ように回転、即ち、ツイストさせて取り外すに際して、その回転力ないしはツイスト力を穿刺部材の先端部に対して効果的に及ぼすことができ、その結果、穿刺部材をその軸方向中心により容易に回転させることができる。 In a preferred aspect, the tip of the puncture member has a blade shape. As a result, when the lancet cap is rotated, i.e., twisted and removed, the rotational force or twisting force can be effectively applied to the tip of the puncture member, and as a result, the puncture member Can be easily rotated by its axial center.
　ここで、ランセットキャップの取り外しに際しては、ランセットキャップの“回転操作”に加えて“引き離し操作（即ち、ランセットキャップと穿刺部材とを相互に引き離す操作）”が必要となるが、その引き離しに際しては穿刺部材の「周方向溝」または「周方向突起」が好適に機能する。具体的には、穿刺部材の先端部からランセットキャップを引き離すに際して、「周方向溝」または「周方向突起」がストッパーとして機能し、穿刺部材の胴部がランセットボディから抜け落ちないことになる。換言すれば、「周方向溝または周方向突起」と「ランセットボディ」との相互の係合に起因して、引き離し方向において大きな抵抗が供されるので、穿刺部材の胴部がランセットボディから抜け落ちないことになる。 Here, in order to remove the lancet cap, in addition to the “rotation operation” of the lancet cap, a “separation operation (ie, an operation to separate the lancet cap and the puncture member from each other)” is required. 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. In other words, due to the mutual engagement between the “circumferential groove or circumferential protrusion” and the “lancet body”, a large resistance is provided in the pulling direction, so that the body of the puncture member falls out of the lancet body. There will be no.
　別のある好適な態様では、ランセットボディとランセットキャップとが一体成形されており、ランセットキャップとランセットボディとがそれらの接点において相互に結合した状態となっている。換言すれば、ランセットキャップとランセットボディとが“接点部分”を介して相互に繋がれている。それゆえ、ランセットキャップの“回転操作”ないしは“引き離し操作”に際しては、ランセットキャップとランセットボディとを繋いでいる接点部分が破壊される。接点部分が破壊されると、ランセットキャップがランセットボディから分離することができるので、穿刺部材にて先端部が露出した状態を得ることができる。 In another preferred aspect, 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. In other words, 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. When 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.
　更に別の好適な態様では、穿刺部材胴部とランセットボディとの間にはシリコーンオイルなどが供されておらず、ランセットボディ内にて穿刺部材胴部がランセットボディ部と直接的に接している。つまり、ランセットキャップの取り外しに際しては、穿刺部材胴部がランセットボディと直接的に接した状態で穿刺部材が回転することになる。これは、本発明のランセットにおいては、穿刺部材胴部とランセットボディとの間に生じる摩擦抵抗に打ち勝って穿刺部材が回転できることを意味している。 In yet another preferred embodiment, 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.
　本発明においてはランセットのみならず、それを用いた穿刺デバイスも提供される。つまり、ランセットを実使用に供するためのデバイスも提供される。本発明に係る穿刺デバイスは穿刺部材を発射できるものであれば、いずれの形態・構成を有していてもよい。例えば、本発明の穿刺デバイスは、ランセット、射出バネ、トリガー部材およびそれらを収容するランセットホルダーを有して成り、
　トリガー部材が、ランセットホルダー内部に設けられる一対のアーム部を備えており、
　射出バネがランセットボディに取り付けられ、穿刺前では射出バネの圧縮状態が維持されるようにランセットボディがトリガー部材のアーム部に係止しており、
　ランセットキャップがランセットから取り外されるとトリガー部材をランセットホルダー内部へと押し込むことができ、かかるトリガー部材の押込みによって一対のアーム部が撓んでランセットボディの前記係止が解除されることを特徴としている。 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. For example, 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,
When the lancet cap is removed from the lancet, 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.
　かかる穿刺デバイスでは、ランセットボディの係止を解除すると、圧縮されていた射出バネが伸びることに起因して、「露出した穿刺部材（先端部）を備えたランセットボディ」を穿刺方向へと発射させることができる。また、本発明の穿刺デバイスでは、好ましくはランセットホルダーの内壁（特にホルダー後方側の内壁面）にスロープ部が設けられており、トリガー部材の押込みに際してそのアーム部がスロープ部を擦動して撓むようになっている。尚、ここでいう「撓む」という用語は、アーム部がランセットホルダー内の空間において変位するあらゆる種類の態様を実質的に意味している。従って、例えば一例として「アーム部が撓む」とは、アーム部がランセットホルダー内において外側に変位する態様、特に、対を成すアーム部の先端部が相互に離れる方向にアーム部が外側へと開く態様を指している。 In such 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. In the puncture device of the present invention, preferably, 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. Note that the term “deflection” here substantially means all kinds of modes in which the arm portion is displaced in the space in the lancet holder. Therefore, for example, as an example, “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.
　本発明のランセットでは、ランセットキャップの取り外しに伴って、穿刺部材が回転することができる。これにより、取り外し時に穿刺部材に及ぼされる力の大部分がその穿刺部材の回転力へと変えられることになるので、曲がりや折れなどの穿刺部材の損傷が防止される。特に穿刺部材における曲がりが防止されると、穿刺部材の軌道が略直線的となり、その結果、被穿刺者（即ち被採血者）が穿刺時に感じる痛みを低減できる。これは、特定の理論に拘束されるわけではないが、穿刺針によって被採血者の穿刺箇所が“えぐられる”といった現象が減じられることに起因するものと考えられる。 In the lancet of the present invention, 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.
　また、本発明のランセットを備えた穿刺デバイスにおいては、穿刺部材の“曲がり”が防止され、実質的に一定した露出状態の穿刺先端部を得ることができる。従って、使用者が異なる場合であっても穿刺部材の穿刺軌道が実質的に一定となり、使用者ごとのばらつきが低減される。 Further, in 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.
図１は、本発明のランセットの外観図である。FIG. 1 is an external view of a lancet according to the present invention. 図２は、本発明のランセットの内部構造を示した断面斜視図である。FIG. 2 is a cross-sectional perspective view showing the internal structure of the lancet of the present invention. 図３は、本発明のランセットの内部構造を示した断面図および平面透過図である。FIG. 3 is a cross-sectional view and a plan transparent view showing the internal structure of the lancet of the present invention. 図４（ａ）～（ｄ）は、ランセットキャップの取り外し操作時におけるランセットの経時変化を模式的に表した断面斜視図である。4 (a) to 4 (d) are cross-sectional perspective views schematically showing changes with time of the lancet during the lancet cap removal operation. 図５は、本発明に従ったランセットの内部構造を示した断面図（図５（ａ）：周方向溝が設けられた穿刺部材、図５（ｂ）：周方向突起が設けられた穿刺部材）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. ) 図６（ａ）は本発明の穿刺デバイスの外観図であり、図６（ｂ）は本発明の穿刺デバイスの内部構造を表した一部切欠斜視図である。FIG. 6A is an external view of the puncture device of the present invention, and FIG. 6B is a partially cutaway perspective view showing the internal structure of the puncture device of the present invention. 図７は、本発明の穿刺デバイスの構成要素を模式的に示した展開図・分解図である。FIG. 7 is a developed / exploded view schematically showing components of the puncture device of the present invention. 図８は、本発明の穿刺デバイスの内部構造を示した一部切欠斜視図である（キャップ取り外し操作前）。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). 図９は、本発明の穿刺デバイスの内部構造を示した一部切欠斜視図である（取り外しに際してキャップを約９０°回転させた状態）。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). 図１０は、本発明の穿刺デバイスの内部構造を示した一部切欠斜視図である（取り外しに際してキャップを約１８０°回転させた状態）。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). 図１１は、本発明の穿刺デバイスの内部構造を示した一部切欠斜視図である（取り外しに際してキャップを穿刺部材から引き離した状態）。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). 図１２は、本発明の穿刺デバイスの内部構造を示した一部切欠斜視図である（穿刺部材が発射された直後の状態）。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). 図１３（ａ）～（ｅ）は、キャップ取り外しから穿刺までに至る一連の経過変化を模式的に示した穿刺デバイスの一部切欠斜視図である。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. 図１４は、ランセットアッセンブリの外観を表した斜視図である。FIG. 14 is a perspective view showing the appearance of the lancet assembly. 図１５は、インジェクターの外観を表した斜視図である。FIG. 15 is a perspective view showing the appearance of the injector. 図１６は、ランセットの外観を表した斜視図である。FIG. 16 is a perspective view showing the appearance of the lancet. 図１７は、ランセットの内部が分かるように、図１６のランセットを半分割した場合の斜視図である。FIG. 17 is a perspective view when the lancet of FIG. 16 is divided in half so that the inside of the lancet can be seen. 図１８は、ランセットアッセンブリがインジェクターに装填される前の態様を示した斜視図である。FIG. 18 is a perspective view showing a state before the lancet assembly is loaded into the injector. 図１９は、ランセットアッセンブリの装填によりランセットがプランジャー先端部に把持された態様を示した斜視図である。FIG. 19 is a perspective view showing a state in which the lancet is gripped by the plunger tip by loading the lancet assembly. 図２０は、ランセットアッセンブリの装填が完了し、プランジャーが後退できない状態となった態様を示した斜視図である。FIG. 20 is a perspective view showing a state in which the lancet assembly is completely loaded and the plunger cannot be retracted. 図２１は、ランセットキャップが外されて穿刺可能状態となった態様を示した斜視図である。FIG. 21 is a perspective view showing a state in which the lancet cap is removed and puncture is possible.
　１００　ランセット
　１３０　ランセットボディ
　１３３　ランセットの後端
　１５０　穿刺部材
　１５２　穿刺部材の先端部
　１５６　穿刺部材の胴部
　１５６ａ　穿刺部材の胴部の外周面
　１５８　周方向溝
　１５８’　周方向突起
　１６０　ランセットボディとランセットキャップとの接点部分
　１７０　ランセットキャップ
　１７２　ランセットキャップの把持部
　２００　ランセットホルダー
　２５０　ランセットホルダーの内壁に設けられたスロープ部材
　３００　射出バネ
　４００　トリガー部材
　４０３　トリガー部材の開口端
　４２０　トリガー部材のアーム部
　４２０ａ　アーム部の先端部
　４２０ｂ　アーム部のスロープ面
　４２１　アーム部の内側面に設けられた被係止部
　４５０　トリガー部材の嵌合部
　５００　穿刺デバイス
　１００’　ランセットアッセンブリ
　１０１’　ランセット
　１０２’　保護カバー
　１０４’　ランセットボディ
　１０５’　穿刺針
　１０６’　ランセットキャップ
　１０８’　弱化部材
　１１４’　ランセットボディの前方部分
　１１６’　ランセットボディの後方部分
　２００’　インジェクター
　２０４’　プランジャー
　２１４’　インジェクターの前端開口部
　２６４’,２６６’　プランジャーの先端部
　５１４’　トリガー部材
　５２４’　プランジャーに設けられた突起
　５２６’　トリガー部材の後方部分端部
　５４２’　トリガー部材のプレス部分 100 lancet 130 lancet body 133 rear end of lancet 150 puncture member 152 tip of puncture member 156 body of puncture member 156a outer circumferential surface of body of puncture member 158 circumferential groove 158 'circumferential projection 160 lancet body and lancet cap Lancet cap 172 lancet cap gripping part 200 lancet holder 250 slope member provided on the inner wall of the lancet holder 300 injection spring 400 trigger member 403 trigger member opening end 420 trigger member arm part 420a tip part of arm part 420b Slope surface of arm portion 421 Locked portion provided on inner surface of arm portion 450 Trigger member fitting portion 500 Puncture device 100 'lancet assembly 101' lancet 102 'protective cover 104' lancet body 105 'puncture needle 106' lancet cap 108 'weakening member 114' lancet body front part 116 'lancet body rear part 200' injector 204 'plunger 214' injector front end opening 264 ' , 266 ′ Plunger tip 514 ′ Trigger member 524 ′ Protrusion provided on the plunger 526 ′ Rear portion end portion of the trigger member 542 ′ Press portion of the trigger member
　添付図面を参照して本発明に係るランセットおよびそれを搭載した穿刺デバイスについて詳細に説明する。 The lancet according to the present invention and a puncture device equipped with the lancet will be described in detail with reference to the accompanying drawings.
　本明細書で用いる“方向”については次の通り規定する。穿刺に際して穿刺部材が発射される方向が「前」方向であり、その反対の方向が「後」方向である。これらの方向は図面に示している。尚、「穿刺方向」は、採血されるべき穿刺部位に向かって穿刺部材が移動する方向を実質的に意味しており、“前方向”に相当する。 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”.
《本発明のランセット》
　以下では、まず、本発明に係るランセットについて説明する。 《Lancet of the present invention》
Below, the lancet which concerns on this invention is demonstrated first.
（ランセットの構成・態様）
　本発明のランセット１００は、図１～３に示される。図１は、ランセット１００の全体外観を示す斜視図であり、図２は、ランセット１００の内部構造を示す斜視図であり、図３は、ランセット１００の上面図および側面図である。 (Structure / mode of lancet)
The lancet 100 of the present invention is shown in FIGS. 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, and FIG. 3 is a top view and a side view of the lancet 100.
　図示するように、ランセット１００は、ランセットボディ１３０、ランセットキャップ１７０および穿刺部材１５０を有して成る（穿刺部材１５０については特に図２および図３を参照のこと）。穿刺部材１５０は例えば金属製の部材である。一方、ランセットボディ１３０およびランセットキャップ１７０は例えば樹脂製の部材である。特に図３に示すように、穿刺部材１５０はランセットボディ１３０およびランセットキャップ１７０にまたがって延在しており、穿刺部材の先端部１５２がランセットキャップ１７０で被覆されている一方、穿刺部材の胴部１５６がランセットボディ１３０で包接されている。 As shown, 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. On the other hand, the lancet body 130 and the lancet cap 170 are, for example, resin members. In particular, as shown in FIG. 3, 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.
　ランセットボディ１３０とランセットキャップ１７０とは、僅かな接点１６０を介して一体的に結合されている。また、図示するように、穿刺部材１５０の先端部１５２は好ましくはブレード形態を有している（換言すれば、穿刺部材は“ブラッド型”であることが好ましい）。尚、本明細書にいう「ブレード形態」とは、ｂｌａｄｅ（刀）に基づいて称されており、少なくとも１つの面によって縁が鋭くなった形態を実質的に意味している。 The lancet body 130 and the lancet cap 170 are integrally coupled through a few contact points 160. Further, as shown in the figure, 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.
　穿刺部材の胴部１５６はランセットボディ１３０内に設けられているものの、好ましくは図１～３に示すようにランセットボディ１３０内を貫通するように設けられている。つまり、本明細書でいう「包接」とは、穿刺部材の胴部１５６がランセットボディ１３０に接して包み込まれるように設けられている態様を指しているものの、特に好ましくは穿刺部材の胴部１５６がランセットボディ内を貫通するように延在している態様を指している。ここで、本発明においては、穿刺部材１５０の胴部１５６がランセットボディ１３０に接して包み込まれるように設けられているものの、その胴部１５６がランセットボディ１３０に対して固定されてはいない。即ち、穿刺部材１５０の胴部１５６がランセットボディ１３０内に設けられているものの、胴部１５６とランセットボディ１３０とが相互に接着されておらず、それゆえ、外力によって穿刺部材１５０の胴部１５６がその軸方向を中心に回転できるようになっている。 Although 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. In other words, 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. Here, in the present invention, 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. That is, although 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.
　穿刺部材の胴部１５６においては少なくとも１つの周方向溝１５８が設けられている。かかる周方向溝１５８は、例えば図２に示すように、穿刺部材胴部の外周面１５６ａにおいて環状方向に沿って窪んだ凹部形態を有している（別の表現を用いれば、穿刺部材の胴部１５６に“スリット”が設けられているともいえる）。図示する態様から分かるように、周方向溝１５８はランセットボディ１３０に内在しており、そのランセットボディ部と直接的に接するように設けられている。 In the body portion 156 of the puncture member, at least one circumferential groove 158 is provided. For example, as shown in FIG. 2, 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”. As can be seen from the illustrated embodiment, 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.
　穿刺部材の先端部１５２は、ランセット使用時にて穿刺に供する部分である。即ち、被穿刺者の穿刺部位を突く部分である。かかる穿刺部材の先端部は、衛生面や安全性の点でランセットキャップ１７０によってカバーされている。それゆえ、本明細書でいう「被覆」とは、衛生面や安全性の点で問題のないように穿刺部材の先端部１５２がランセットキャップ１７０で覆われている態様を実質的に意味している。ランセットキャップ１７０自体は、その取り外しに好適な形態を有していることが好ましい。例えば図１に示すように先端部分１７２が扁平形状を有しており、指先で摘んで容易に回転させることができるようになっている。 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.
　本発明のランセット１００は、後述するランセットホルダーに一部収容されて使用されることが多く、それゆえ、小さいサイズを有している。例えば、図１に示される長さ（Ｌ１、Ｌ２、Ｈ、Ｗ）は、Ｌ１＝１０．０～３０．０ｍｍ（例えば約２３ｍｍ）、Ｌ２＝１０．０～４０．０ｍｍ（例えば約１３ｍｍ）、Ｈ＝０．９～２０．０ｍｍ（例えば約７ｍｍ）、Ｗ＝２．０～３０．０ｍｍ（例えば約１１ｍｍ）であってよい。また、穿刺部材１５０についていえば、図２に示すような全体長さＬ３は、１２．０～２６．０ｍｍ（例えば約１８ｍｍ）であってよい。そして、穿刺部材の胴部１５６は好ましくは円柱形状態を有しており、径寸法Ｄが好ましくは０．３ｍｍ～１．８ｍｍ、より好ましくは０．９～１．８ｍｍ、更に好ましくは１．４～１．６ｍｍ（例えば約１．５ｍｍ）となっている（図２参照）。 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. For example, the lengths (L 1 , L 2 , H, W) shown in FIG. 1 are L 1 = 10.0 to 30.0 mm (for example, about 23 mm) and L 2 = 10.0 to 40.0 mm (for example, About 13 mm), H = 0.9-20.0 mm (eg about 7 mm), W = 2.0-30.0 mm (eg about 11 mm). Further, As for the piercing member 150, 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).
　ランセットボディおよびランセットキャップの材質としては、ポリエチレン、ポリプロピレンなどのランセットの樹脂として通常採用されるものであってよいものの、好ましくは低密度若しくは高密度ポリエチレン、ポリスチレンおよびエラストマーから成る群から選択される少なくとも１種以上の軟質樹脂である。穿刺部材１５０の金属材質としては、ランセットの穿刺針として通常採用されているものであってよく、例えばステンレス鋼であってよい。 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.
　本発明のランセットの最たる特徴は、穿刺部材がその軸方向を中心に回転自在となっていることである。特にランセットキャップをもぎり取る際（即ち“ツイスト”する際）に穿刺部材がその軸方向を中心に回転できるようになっている。具体的には、図４に示すように、ランセットキャップ１７０の取り外しに伴って穿刺部材１５０が回転することができる。即ち、図示する矢印Ａの方向へとランセットキャップ１７０を回転運動させる際に、穿刺部材１５０も同様に矢印Ａの方向に沿って回動する。これは、穿刺部材１５０の胴部１５６がランセットボディ１３０に接して包み込まれるように設けられているものの、その胴部１５６がランセットボディ１３０に固定されていないことに起因している。ランセットキャップの取り外しに際しては、穿刺部材の先端部１５２に対して回転運動する力が加えられることになるが、その力が先端部１５２と一体化した穿刺部材胴部１５６にも伝わり、その結果、胴部１５６が回転することになる。それゆえ、ランセットキャップの取り外しに際しては穿刺部材１５０が全体としてその軸方向を中心として回転することになる。 The main feature of the lancet of the present invention is that the puncture member is rotatable around its axial direction. In particular, when the lancet cap is torn off (ie, when “twisted”), the puncture member can rotate about its axial direction. Specifically, as shown in FIG. 4, 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. When removing the lancet cap, a rotational force is applied to the tip portion 152 of the puncture member, but the force is also transmitted to the puncture member body 156 integrated with the tip portion 152, and as a result, The trunk 156 is rotated. Therefore, when removing the lancet cap, the puncture member 150 as a whole rotates about its axial direction.
　このように、ランセットキャップ１７０の取り外しに際するもぎり操作に伴って穿刺部材１５０が回転するので、先端部の曲がりや折れなどの穿刺部材の損傷が防止される。逆にいえば、仮に胴部１５６がランセットボディ１３０に固定されている場合を想定すると、もぎり操作に伴ってランセットキャップに捻る力が加えられることになるが、その中に存在する穿刺部材が抵抗となって、その捻りに抗する力が生じるので、最終的にはランセットキャップが破断されてしまう。あるいは、キャップが破壊されない場合であっても、もぎり操作に伴って穿刺部材の先端部１５２には回転運動しようとする力が働く一方、穿刺部材の胴部１５６にはそれに抗する力が働くので、穿刺部材の先端部１５２が曲がることになり、その力がある閾値を超えると、先端部１５２が折れてしまうことにもなる。特に穿刺部材の先端部１５２がブレード形態を有している場合には、もぎり操作に伴って穿刺部材の先端部１５２に加えられる力が大きくなり、ランセットキャップの“破断”や穿刺部材先端部１５２の“曲がり”や“折れ”が引き起こされ易くなる。この点、本発明では、そのようなもぎり時の力が大きい場合であっても、そのもぎり時の回転力を逆に好適に利用して、“ランセットキャップの破断”や“穿刺部材の曲がり”を防止している。 As described above, since 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. Speaking conversely, assuming that the body 156 is fixed to the lancet body 130, 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. Alternatively, even when the cap is not 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. In particular, when 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”. In this regard, in the present invention, even when such a force at the time of cutting is large, 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.
　ランセットキャップ１７０の取り外しに際しては、キャップ１７０の回転操作に加えて引き離し操作を行うことになる。本発明では、この引き離し操作を行ったとしても穿刺部材の胴部がランセットボディ１３０から抜けてしまうことはない。つまり、穿刺部材１５０の胴部１５６はランセットボディ１３０に固定されていないのにも拘わらず、その胴部１５６がランセットボディ１３０から抜けないようになっている。これは、穿刺部材の胴部１５６に周方向溝１５８が設けられていることに起因する。周方向溝１５８は上述したようにランセットボディ１３０に内在しているが、その有する凹部形態が“抵抗”を供することになり、穿刺部材１５０の胴部１５６の脱離が防止される。つまり、穿刺部材の先端部からランセットキャップを引き離すに際しては、周方向溝がストッパーとして機能することになり、穿刺部材胴部がランセットボディから抜け落ちないようになっている。 When removing the lancet cap 170, the pulling operation is performed in addition to the rotation operation of the cap 170. In the present invention, even if this pulling-out operation is performed, 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. This is due to the circumferential groove 158 provided in the body 156 of the puncture member. Although 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.
　周方向溝１５８は、ランセットキャップの引き離し操作に対して抵抗を供することになればよいので、その形態は“溝形態”に限られず、他の形態も可能である。例えば、“フランジ形態”であってもよい。具体的には、図５（ｂ）に示すように、穿刺部材の胴部に周方向突起１５８’が設けられていてもよい。つまり、穿刺部材胴部の外周面１５６ａにおいて環状方向に沿って隆起した凸部が設けられていてよい。かかる場合であっても、周方向突起１５８’とランセットボディ１３０とが相互に係合しているので、穿刺部材の先端部からランセットキャップを引き離すに際しては周方向突起１５８’がストッパーとして好適に機能し、穿刺部材胴部がランセットボディから抜け落ちないようになる。 Since the circumferential groove 158 only needs to provide resistance to the operation of pulling the lancet cap, the form is not limited to the “groove form”, and other forms are possible. For example, a “flange shape” may be used. Specifically, as shown in FIG. 5B, 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 | drum. Even in such a case, since 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.
　周方向溝１５８または周方向突起１５８’の寸法は、ランセットキャップの引き離し操作に際してそれらがストッパーとして機能するのであれば特に制限はない。例えば、図５（ａ）に示すような周方向溝１５８の場合、その幅寸法ｗａは０．２～３．０ｍｍ（例えば約１ｍｍ）であってよく、その深さ寸法ｄａは０．１～１．０ｍｍ（例えば約０．５ｍｍ）であってよい。同様に、図５（ｂ）に示すような周方向突起１５８’の場合、その幅寸法ｗｂは０．２～３．０ｍｍ（例えば約１ｍｍ）であってよく、その高さ寸法ｈｂは０．１～１．０ｍｍ（例えば約０．５ｍｍ）であってよい。尚、周方向溝１５８の深さ寸法ｄａについていえば、必要以上に大きくすると穿刺部材胴部の強度が低下するので、少なくとも胴部の径寸法Ｄの２５％を超えないこと、即ち、ｄａ＜Ｄ×０．２５であることが好ましい。 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. For example, in the case of the circumferential groove 158 as shown in FIG. 5A, the width dimension wa may be 0.2 to 3.0 mm (for example, about 1 mm), and the depth dimension da is 0.1 to 3.0 mm. It may be 1.0 mm (eg about 0.5 mm). Similarly, in the case of the circumferential protrusion 158 ′ as shown in FIG. 5B, the width dimension wb may be 0.2 to 3.0 mm (for example, about 1 mm), and the height dimension hb is 0. It may be 1 to 1.0 mm (eg about 0.5 mm). In addition, as for 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.
　ここで、周方向溝１５８または周方向突起１５８’は、ランセットキャップの引き離し操作時にストッパーとして機能するだけでなく、穿刺部材の回転運動を助力する作用をも有している。これは、周方向溝１５８や周方向突起１５８’が設けられていない穿刺部材を想定すると理解し易い。実際のランセットキャップの回転操作に際してはランセットキャップと穿刺部材とを相互に引き離すような力も多少生じることになるが、周方向溝１５８や周方向突起１５８’が設けられていない場合であると図５（ａ）および（ｂ）に示すＢ方向に“抵抗”が供されないために、ランセットキャップの回転操作時に穿刺部材胴部１５６とランセットボディ１３０との相対的位置関係（特に図５に示すＢ方向における相対的位置関係）がずれてしまうことになる。この点、穿刺部材の胴部１５６に周方向溝１５８や周方向突起１５８’が設けられていると、ランセットキャップの回転操作において引き離す力が生じたとしても、穿刺部材胴部１５６とランセットボディ１３０との相対的位置関係（即ち図５に示すＢ方向における相対的位置関係）がずれることがないので、穿刺部材のスムーズな回転運動が実現されることになる。 Here, 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. Since “resistance” is not provided in the B direction shown in (a) and (b), the relative positional relationship between the puncture member body 156 and the lancet body 130 during rotation of the lancet cap (particularly in the B direction shown in FIG. 5) The relative positional relationship in (1) will shift. In this respect, when the circumferential groove 158 and the circumferential projection 158 ′ are provided in the body portion 156 of the puncture member, the puncture member body portion 156 and the lancet body 130 can be obtained even if a force to separate them is generated in the rotation operation of the lancet cap. Since the relative positional relationship with (i.e., the relative positional relationship in the B direction shown in FIG. 5) does not shift, smooth rotation of the puncture member is realized.
　この周方向溝１５８または周方向突起１５８’は、ランセットキャップの取り外し時だけでなく、キャップを取り外した後の穿刺時においても有利な効果を奏する。具体的には、周方向溝１５８や周方向突起１５８’が設けられていると、穿刺部材の脱離が防止されるので、穿刺後にて穿刺部材１５０が被穿刺者の部位に残ってしまう不具合が防止される。また、穿刺部材胴部１５６とランセットボディ１３０との相対的位置関係がずれないので、穿刺時において所定の穿刺深さを確実に実現できる。更にいえば、本発明においては、周方向溝１５８または周方向突起１５８’に起因して胴部１５６とランセットボディ１３０との相対的位置関係がずれることなく穿刺部材がその軸方向を中心に回転運動できるので、穿刺時の振動を低減することができる。つまり、穿刺時には穿刺部材の先端部が波打つように振動することがあるが、その際に穿刺部材の回転運動がその波打つエネルギーを吸収することができる。それゆえ、周方向溝１５８または周方向突起１５８’は、穿刺時にて穿刺軌道の直線性向上に間接的に寄与しているといえる。 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. Furthermore, in the present invention, 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.
（ランセットキャップ取り外し時の経時変化）
　図４（ａ）～（ｄ）を参照して、ランセットキャップ取り外し時の経時変化について説明する。図４（ａ）～（ｄ）は、その番号順にランセット１００の経時変化を示している。図４（ａ）は、ランセットキャップ取り外し操作前の態様である。図示するように、穿刺前の状態においては、ランセットキャップ１７０によって穿刺部材１５０の先端部１５２が被覆されている。また、かかる穿刺前の状態では、ランセットキャップ１７０とランセットボディ１３０とが接点部分１６０を介して相互に結合している。図４（ｂ）は、ランセットキャップの取り外し操作を始めた時点の態様を示している。取り外し操作に際しては、ランセットキャップの把持部１７２を指先などで摘んで“もぎり操作”を実施する。具体的には、ランセットボディ１３０を固定しつつ、図示するＡ方向にランセットキャップを回転させる。これにより、ランセットキャップに内在している穿刺部材の先端部１５２に対して同様に回転する力が働き、ひいては、穿刺部材１５０が全体的にその軸方向中心に回転する。このような回転が行われることによって、キャップ取り外し時における穿刺部材の曲がりや折れなどが防止される。ランセットキャップをある程度回転させると、ランセットキャップ１７０とランセットボディ１３０との間の接点部分１６０が破壊される（例えば、図４（ｃ）参照）。そして、接点部分１６０が破壊された後は、図４（ｄ）に示すように穿刺部材の先端部１５２からランセットキャップ１７０を引き離すような操作を行う。これにより、穿刺部材の先端部１５２を露出させる。この際、ランセットボディ１３０と周方向溝１５８との摩擦抵抗に起因して、穿刺部材の胴部１５６がランセットボディ１３０から抜け落ちることはない。つまり、穿刺部材の先端部１５２からランセットキャップ１７０を引き離したとしても、周方向溝１５８がストッパーとして機能して穿刺部材の“抜け”を防ぐことになる。以上のような態様を経ることによって、曲がりなどの損傷なく穿刺部材の先端部を好適に露出させることができる。 (Change over time when removing the lancet cap)
With reference to 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. In the detaching operation, 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). Then, after the contact portion 160 is destroyed, an operation is performed to pull the lancet cap 170 away from the distal end portion 152 of the puncture member as shown in FIG. Thereby, the front-end | tip part 152 of a puncture member is exposed. At this time, due to the frictional resistance between the lancet body 130 and the circumferential groove 158, the body 156 of the puncture member does not fall out of the lancet body 130. That is, even if the lancet cap 170 is pulled away from the distal end portion 152 of the puncture member, the circumferential groove 158 functions as a stopper to prevent the “puncture” of the puncture member. By passing through the above aspects, the tip of the puncture member can be suitably exposed without damage such as bending.
（ランセットの製造）
　次に、本発明のランセットの製造について説明する。本発明に係るランセット１００は、穿刺部材１５０を金型にインサートして樹脂原料を成型するいわゆるインサート成形によって製造することができる。ランセットキャップ１７０とランセットボディ１３０とを相互に結合している接点部分（即ち“ブリッジ部分”）は、このインサート成形の際に併せて製造することができる。従って、“接点部分”は、ランセットキャップ１７０およびランセットボディ１３０と同じ樹脂原料から形成され得る。かかる“接点部分”は、キャップ取り外し時に破壊されることが求められ、それゆえ、接点部分を「弱化部分」または「易破壊部分」と呼ぶこともできる。尚、接点部分がより容易に破壊されるように、接点部分にノッチを設けてもよい。場合によっては、接点部分が予め切断されている形態、更には接点部分が存在しない形態であってもよく、ランセットキャップの“もぎり操作”に際して「先端部１５２が露出したランセットボディ」を得ることができるのであれば特に問題はない。 (Manufacture of lancets)
Next, production of the lancet of the present invention will be described. 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”. In addition, you may provide a notch in a contact part so that a contact part may be destroyed more easily. Depending on the case, 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.
　インサート成形に際しては穿刺部材１５０を固定した状態で行う。例えば穿刺部材１５０を両側から支持することによってインサート成形を行う。従って、両側から支持されることによって得られたランセットにおいては、その痕跡が残っており、例えば図５（ａ）および（ｂ）に示すような陥没部（１３４ａ，１３４ｂ）が形成されている。 The insert molding is performed with the puncture member 150 fixed. For example, 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.
　尚、インサート成形に供する穿刺部材の「周方向溝１５８」は、例えば切削、旋削、鍛造、転造、プレス加工、レーザー加工などの一般的な機械加工によって形成することができる。同様に、穿刺部材の「周方向突起１５８’」、例えば切削、旋削、鍛造、転造、プレス加工、レーザー加工などの一般的な機械加工によって形成することができる。 Note that 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. Similarly, the “circumferential protrusion 158 ′” of the puncture member can be formed by general machining such as cutting, turning, forging, rolling, pressing, or laser processing.
　付言しておくと、穿刺部材の先端部１５２の滅菌処理は、ランセットキャップが被覆された状態でγ線照射などを行うことによって実施できる。 In other words, the sterilization treatment of the distal end portion 152 of the puncture member can be performed by performing γ-ray irradiation or the like while the lancet cap is covered.
《本発明の穿刺デバイス》
　以下では、本発明に係る穿刺デイバスについて説明する。本発明の穿刺デバイスは上述のランセットを有して成るものである。穿刺時にランセットの穿刺部材１５０を発射できるものであれば、本発明の穿刺デバイスはいずれの形態を有していてもよい。例えば、穿刺デバイス５００は、図６および図７に示すような形態・構成を有していてよい。図６は本発明のランセット穿刺デバイス５００の外観図（図６（ａ））および一部透過図（図６（ｂ））を示しており、図７は、ランセット穿刺デバイス５００の分解図・展開図を示している。特に図７に示す態様から分かるように、本発明に係るランセット穿刺デバイス５００は、「ランセット１００」、「ランセットホルダー２００」、「射出バネ３００」および「トリガー部材４００」から主に構成されている。 << Puncture Device of the Present Invention >>
Hereinafter, the puncture device according to the present invention will be described. 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. For example, 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. As can be seen from the embodiment shown in FIG. 7 in particular, 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”. .
　図６（ｂ）に示すように、本発明のランセット穿刺デバイス５００は、ランセットホルダー２００内にランセット１００、射出バネ３００およびトリガー部材４００が収容された構造を有している。具体的には、図６（ｂ）に示すように、ランセットの後端１３３とトリガー部材の後端部４００ａとの間において射出バネ３００が挟み込まれるように設けられている。更に具体的にいえば、図６（ｂ）および図７に示すように、ランセットホルダー２００内においては、射出バネ３００の一方の端部が、ランセット１００の後端１３３に取り付けられていると共に、射出バネ３００の他方の端部が「トリガー部材４００の嵌合部４５０」に取り付けられている。ここで、本発明の穿刺デバイス５００においては、ランセットボディ１３０に取り付けられた射出バネ３００が圧縮された状態となるように、トリガー部材４００のアーム部４２０に対してランセットボディ１３０が係止された状態となっている（例えば図６（ｂ）参照）。 As shown in FIG. 6B, 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. Specifically, as shown in FIG. 6B, 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”. Here, in the puncture device 500 of the present invention, 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).
　かかる本発明のランセット穿刺デバイスの特徴の１つは、「ランセット」と「トリガー部材」と「ランセットホルダー」と「射出バネ」といった４つの部材から実質的に構成されており、デバイス構成が比較的シンプルであり、かつ、全体サイズが比較的小さいことである。 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.
　以下では本発明の穿刺デバイス５００の構成要素について説明していく。尚、ランセットについては上記で既に説明しているので重複を避けるために、ここでの説明は省略する。 Hereinafter, components of the puncture device 500 of the present invention will be described. Since the lancet has already been described above, the description thereof is omitted here to avoid duplication.
　（ランセットホルダー）
　ランセットホルダー２００は、図６（ａ）に示すように、例えば全体として角筒の形態を有している。かかるランセットホルダー２００は、上述のランセットを部分的に収容するものであり、ランセット同様に小さくなっている。尚、ランセットホルダー２００の形状については必ずしも角筒の形態に限定されるものではなく、例えば円筒の形態であってもよい。ランセットホルダー２００は、一般的なランセットに用いられる樹脂材料であれば、いずれの種類の樹脂材料から形成してもよい。 (Lancet holder)
As shown in FIG. 6A, 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. Note that 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.
　ランセットホルダー２００の内壁面には、トリガー部材のアーム部４２０と協働して機能する“スロープ部”が設けられている。この“スロープ部”は、例えば図１２および図１３（ｅ）にて参照番号２５０（“斜線部分”）で示されている。かかるスロープ部２５０は、トリガー部材の押込みに際してアーム部４２０が擦動する部分であり、穿刺操作時にてアーム部の撓みを実現する。 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.
（トリガー部材）
　ランセット穿刺デバイス５００に用いるトリガー部材４００は、図７に示すように、対を成すアーム部４２０を有して成る。このようなトリガー部材４００は、ランセット１００と同様の樹脂（例えばポリエチレン、ポリプロピレン等）から成形したものであってよい。アーム部４２０は、全体として可撓性を有していることが好ましい。特に、対を成すアーム部の先端部、即ち、自由端部４２０ａが相互に離れる方向に外側へと撓むようになっていることが好ましい。これにより、トリガー部材の押込みに際しては、ランセットボディの係止が解除されるようにアーム部４２０が好適に機能することになる。 (Trigger member)
As shown in FIG. 7, the trigger member 400 used in the lancet puncture device 500 includes a pair of arm portions 420. Such 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. In particular, it is preferable that 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. As a result, when the trigger member is pushed, the arm portion 420 functions favorably so that the lancet body is unlocked.
　一対のアーム部４２０の先端部４２０ａには、ランセットホルダー２００のスロープ部２５０と当接し得るスロープ面４２０ｂを備えている（例えば図６（ｂ）または図８参照）。特に、スロープ面４２０ｂは、ランセットホルダー２００のスロープ部２５０と相補的な形態を有していることが好ましく、それによって、トリガー部材の押込みに際してアーム部４２０のスロープ面４２０ｂがホルダー２００のスロープ部２５０上を好適に擦動することが可能となる。 The tip part 420a of a pair of arm part 420 is provided with the slope surface 420b which can contact | abut with the slope part 250 of the lancet holder 200 (for example, refer FIG.6 (b) or FIG. 8). In particular, 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.
　トリガー部材の一対のアーム部４２０には、穿刺前においてランセットボディ１３０が係止されることになる被係止部が設けられている。具体的には、図６（ｂ）に示すように、一対のアーム部４２０の内側面には隆起形状の被係止部４２１が形成されている。 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.
　（射出バネ）
　射出バネ３００は、その名の通り“射出”ないしは“発射”に供するものである。換言すれば、射出バネ３００は、穿刺部材１５０、特に「露出した穿刺部材を備えたランセットボディ」に対して発射または穿刺のための推進力を与えるバネである。かかる射出バネ３００は、上述したように、「トリガー部材４００のバネ取付け部４５０」と「ランセット１００」との間にて圧縮された状態で設けられる（図６（ｂ）参照）。かかる射出バネ３００は金属製であることが好ましく、例えば金属製のコイルバネである。射出バネ３００のサイズは、ランセットホルダー内に収容されるものではあれば、特に制限ない。 (Injection spring)
The injection spring 300 is used for “injection” or “firing” as the name suggests. In other words, 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”. As described above, 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.
《穿刺デバイスの使用態様》
　以下では、本発明のランセット穿刺デバイスの使用態様について説明しておく。図８～図１２は、その番号順にランセット穿刺デバイス５００の経時変化を示している。なお、全体的な流れが理解できるように図１３（ａ）～（ｅ）には一連の経時変化を纏めて示す。 << Usage of puncture device >>
Below, the usage aspect of the lancet puncture device of this invention is demonstrated. 8 to 12 show changes over time of the lancet lancing device 500 in numerical order. In order to understand the overall flow, FIGS. 13A to 13E collectively show a series of changes with time.
　穿刺前の状態の本発明の穿刺デバイス５００は図８および図１３（ａ）に示される。かかる穿刺前の状態では、穿刺部材の先端部１５２を被覆するようにランセットキャップ１７０が設けられていると共に、射出バネ３００が、「トリガー部材の後端部４００ａ」と「ランセット１００」との間において圧縮された状態となっている。 The puncture device 500 of the present invention before puncturing is shown in FIGS. 8 and 13 (a). In such a state before puncturing, 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”. In a compressed state.
　穿刺に際しては、ランセットからランセットキャップ１７０が取り外される。ランセットキャップ１７０の取外しには、ランセットキャップ１７０の“もぎり取り操作”を行う。具体的には、まず図９および図１３（ｂ）に示すように、ランセットキャップ１７０（特に把持部１７２）を回転させて「ランセットボディ１３０とランセットキャップ１７０との接点部分」を破壊させる。別の表現を用いると、一方の手でランセットホルダー２００を外側からつまんで保持した状態とし、他方の手の指でランセットキャップ１７０の把持部１７２を捻るような操作を行う。これにより、ランセットキャップに内在している穿刺部材の先端部１５２がランセットキャップの回転に伴い同様に回転運動し、そして、先端部１５２と一体化している穿刺部材胴部１５６も同様に回転することになる。つまり、ランセットキャップ１７０の回転運動に伴って、穿刺部材１５０が全体としてその軸方向を中心として回転する。 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. As a result, 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.
　ランセットキャップをある程度回転させると、ランセットキャップ１７０とランセットボディ１３０との間の接点部分１６０が破壊されることになる。例えば、図１０および図１３（ｃ）に示すようにランセットキャップ１７０を約１８０°回転させると、接点部分１６０が破壊される。 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. For example, when the lancet cap 170 is rotated about 180 ° as shown in FIGS. 10 and 13C, the contact portion 160 is broken.
　接点部分１６０が破壊された後は、穿刺部材の先端部からランセットキャップを引き離す操作を行う。これにより、図１１および図１３（ｄ）に示すように、穿刺部材の先端部１５２を露出させることができる。かかるランセットキャップの引き離し操作に際しては、穿刺部材胴部の周方向溝１５８がストッパーとして機能することになるので、穿刺部材胴部１５６がランセットボディ１３０から抜け落ちることはない。 After the contact portion 160 is destroyed, an operation of pulling the lancet cap away from the tip of the puncture member is performed. Thereby, as shown to FIG. 11 and FIG.13 (d), the front-end | tip part 152 of a puncture member can be exposed. When the lancet cap is pulled apart, the circumferential groove 158 of the puncture member body portion functions as a stopper, so that the puncture member body portion 156 does not fall out of the lancet body 130.
　ランセットキャップを取り外した後においては、図１２および図１３（ｅ）に示すように、穿刺すべき所定の部位（例えば指先）にトリガー部材４００の開口端４０３をあてがった後、トリガー部４００をホルダー内部に向かって押し込む操作を行う。トリガー部の押し込みは、ランセットホルダー２００を保持した状態で穿刺デバイスを「穿刺すべき所定の部位」に向かって押さえ付けることによって行うことができる（即ち、“印鑑を押す”ような操作で行うことができる）。トリガー部材４００が押圧されると、トリガー部材のアーム部の先端部４２０ａ（特に４２０ｂのアーム面）がホルダーのスロープ部２５０を擦動することによりアーム部が全体的に外側へと撓み、その結果、ランセットボディの係止部とアーム部の被係止部との当接状態が解除される（即ち、ランセットボディの係止状態が解除される）。ランセットボディの係止が解除されると、圧縮されていた射出バネ３００が伸びることによって、露出した穿刺部材を備えたランセットボディ１３０が穿刺方向へと発射される。発射後では、穿刺方向に向かってランセットボディ１３０が移動して、トリガー部材の開口端４０３から穿刺部材１５０が露出することになり、その結果、開口端４０３にあてがわれた所定の部位が穿刺される。穿刺後は、伸びた射出バネ３００が元の形状に戻ろうとするので、穿刺部材１５０が素速く後退することになる。具体的には、「露出した穿刺部材を備えたランセットボディ１３０」は射出バネ３００に取り付けられているので、その射出バネに引っ張られる形態でランセットボディ１３０が後退することになり、最終的には、穿刺部材１５０がランセットホルダー２００内へと収納される。 After removing the lancet cap, as shown in FIG. 12 and FIG. 13 (e), after the opening end 403 of the trigger member 400 is applied to a predetermined part (for example, fingertip) to be punctured, 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). When the trigger member 400 is pressed, the tip portion 420a (particularly, the arm surface of 420b) of 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). When 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. After the launch, 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. As a result, a predetermined part applied to the opening end 403 is punctured. Is done. After puncturing, since the extended injection spring 300 tries to return to the original shape, the puncturing member 150 is quickly retracted. Specifically, since 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.
　以上、本発明の実施形態について説明してきたが、あくまでも典型例を例示したに過ぎない。従って、本発明はこれに限定されず、種々の態様が考えられることを当業者は容易に理解されよう。例えば以下の態様が考えられる。 As mentioned above, although the embodiment of the present invention has been described, a typical example is merely illustrated. Therefore, those skilled in the art will easily understand that the present invention is not limited to this, and various modes are conceivable. For example, the following modes can be considered.
● 上述した態様では、２面取りのブレード型穿刺部材を例示したものの、必ずしもそれに限定されるわけでなく、ブレード型穿刺部材は３面取りなどの他の面取り形態であってもよい。また、更にいえば、ランセットキャップを回転させて取り外す際にその回転力を穿刺部材の先端部に対して及ぼすことができるものであれば、即ち、ランセットキャップの取り外しに伴って穿刺部材の先端部に回転力を与えることができるのであれば、ブレード型の穿刺部材でなくてもよく、穿刺先端部が“針形態”となっているものであってもよい。 In the above-described embodiment, 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. In addition, when the lancet cap is rotated and removed, 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. As long as a rotational force can be applied, the blade-type puncture member does not have to be provided, and the puncture tip portion may have a “needle shape”.
● また、上述した態様においては、ランセットの取り外しを“回転操作”と“引き離し操作（引き抜き操作）”とに分けて主に説明したが、ランセットキャップを取り外す実際のツイスト操作においては、ランセットキャップの“回転”と“引き抜き”とをほぼ同時にねじりながら行う場合も多い。かかる場合であっても、本発明の効果の点では変わりがなく、周方向溝１５８または周方向突起１５８’がストッパーとして機能しつつ穿刺部材１５０が軸方向中心に回転することによって穿刺部材の曲がり・折れなどが防止される。 In the above-mentioned mode, the removal of the lancet is mainly described as “rotation operation” and “separation operation (pull-out operation)”. However, in the actual twisting operation to remove the lancet cap, In many cases, “rotation” and “pulling” are performed while twisting almost simultaneously. Even in such a case, there is no change in the effect of the present invention, and the bending of the puncture member is caused by the puncture member 150 rotating about the axial direction while the circumferential groove 158 or the circumferential projection 158 ′ functions as a stopper.・ Folding is prevented.
● また、上述した態様では、例えば図５に示すように周方向溝１５８または周方向突起１５８’が連続的に形成されたものを例示したものの、必ずしもそれに限定されるわけではない。周方向溝１５８または周方向突起１５８’は、ランセットキャップの取り外し時に穿刺部材の軸方向中心の回転を阻害せずに“ストッパー”として機能するのであれば、断続的に形成されていているものであってもよい。つまり、周方向溝１５８は、穿刺部材胴部の外周面にて環状方向に間欠的に窪んだ凹部形態を有していてもよく、周方向突起１５８’は、穿刺部材胴部の外周面にて環状方向に間欠的に隆起した凸部形態を有していてもよい。 In the above-described embodiment, the circumferential groove 158 or the circumferential projection 158 'is continuously formed as shown in FIG. 5, for example. However, the present invention is not necessarily limited thereto. 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. There may be. That is, 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.
● 更には、本発明においては、ランセットキャップ取り外し時に穿刺部材が容易に回転するように、ランセットボディを部分的に切り欠いて穿刺部材を露出させた形態であってもよい。つまり、穿刺部材が回転時に受け得る擦動抵抗を効果的に低減すべく、ランセットボディ部と直接的に接する穿刺部材胴部の面積を適宜減じてよい。この点、インサート成形に際して生じる陥没部（１３４ａ，１３４ｂ）は、穿刺部材を部分的に露出させるものであるので、穿刺部材の回転に効果的に寄与し得る（図５（ａ）および（ｂ）参照）。 Furthermore, in the present invention, 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. In this respect, 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).
　尚、上述のような本発明は、次の態様を包含している：
第１態様：穿刺部材、ランセットボディおよびランセットキャップ
を有して成るランセットであって、
　穿刺部材の先端部がランセットキャップで被覆される一方、穿刺部材の胴部がランセットボディで包接されるように、穿刺部材がランセットボディおよびランセットキャップにまたがって延在しており、
　穿刺部材の胴部には周方向溝または周方向突起が設けられており、穿刺部材がその軸方向を中心に回転自在となっていることを特徴とする、ランセット。
第２態様：上記第１態様において、穿刺部材の先端部がブレード形態を有していることを特徴とするランセット。
第３態様：上記第１態様または第２態様において、穿刺部材の先端部からランセットキャップを取り外すに際して該先端部が外力を受けることになり、それによって、穿刺部材がその軸方向中心に回転することを特徴とするランセット。
第４態様：上記第１態様～第３態様のいずれかにおいて、ランセットキャップの前記取り外しに際しては、ランセットボディと前記周方向溝または前記周方向突起との相互に係合に起因して、穿刺部材の胴部がランセットボディから抜けないことを特徴とするランセット。
第５態様：上記第１態様～第４態様のいずれかにおいて、ランセットボディ内においては穿刺部材の胴部がランセットボディと直接的に接していることを特徴とするランセット。
第６態様：上記第１態様～第５態様のいずれかのランセットを有して成る穿刺デバイス。 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.
Third aspect: In the first aspect or the second aspect, when the lancet cap is removed from the distal end portion of the puncture member, the distal end portion receives an external force, whereby the puncture member rotates about its axial center. 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.
Sixth aspect: A puncture device comprising the lancet according to any one of the first to fifth aspects.
　本発明のランセットを用いると、キャップ取り外し時の穿刺部材の曲がりや折れなどを防止できるので、穿刺部材の穿刺軌道が向上して穿刺時の痛みを低減できる。従って、かかるランセットおよびそれを用いた穿刺デバイスは、糖尿病患者の採血に好適に使用できることは当然のこと、その他の採血を必要とする各種用途においても利用することができる。 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.
関連出願の相互参照Cross-reference of related applications
　本出願は、日本国特許出願第２０１０－１３８１７４号（出願日：２０１０年６月１７日、発明の名称：「ランセットおよびそれを用いた穿刺デバイス」）に基づくパリ条約上の優先権を主張する。当該出願に開示された内容は全て、この引用により、本明細書に含まれるものとする。 This application claims priority under the Paris Convention based on Japanese Patent Application No. 2010-138174 (filing date: June 17, 2010, title of the invention: “lancet and puncture device using the same”) . All the contents disclosed in the application are incorporated herein by this reference.

Claims (5)

  1. 　穿刺部材、
    　ランセットボディ、および
    　ランセットキャップ
    を有して成るランセットであって、
    　穿刺部材の先端部がランセットキャップで被覆される一方、穿刺部材の胴部がランセットボディで包接されるように、穿刺部材がランセットボディおよびランセットキャップにまたがって延在しており、
    　穿刺部材の胴部には周方向溝または周方向突起が設けられており、穿刺部材がその軸方向を中心に回転自在となっていることを特徴とする、ランセット。     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 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.
  2. 　穿刺部材の先端部がブレード形態を有しており、また
    　穿刺部材の先端部からランセットキャップを取り外すに際して該先端部が外力を受けることになり、それによって、穿刺部材がその軸方向中心に回転することを特徴とする、請求項１に記載のランセット。     The distal end portion of the puncture member has a blade shape, and when the lancet cap is removed from the distal end portion of the puncture member, the distal end portion receives an external force, whereby the puncture member rotates about its axial direction. The lancet according to claim 1, wherein:
  3. 　ランセットキャップの前記取り外しに際しては、ランセットボディと前記周方向溝または前記周方向突起との相互に係合に起因して、穿刺部材の胴部がランセットボディから抜けないことを特徴とする、請求項１に記載のランセット。 The lancet cap is removed when the lancet body and the circumferential groove or the circumferential protrusion are engaged with each other so that the body portion of the puncture member does not come out of the lancet body. The lancet according to 1.
  4. 　ランセットボディ内においては穿刺部材の胴部がランセットボディと直接的に接していることを特徴とする、請求項１に記載のランセット。 The lancet according to claim 1, wherein a body portion of the puncture member is in direct contact with the lancet body in the lancet body.
  5. 　請求項１に記載のランセットを有して成る穿刺デバイス。 A puncture device comprising the lancet according to claim 1.
PCT/JP2011/062804 2010-06-17 2011-06-03 Lancet and puncture device using same WO2011158669A1 (en)

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JP2010-138174 2010-06-17

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EP2486852A1 (en) * 2009-10-07 2012-08-15 Asahi Polyslider Co., Ltd. Lancing device
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 (en) * 2012-08-30 2014-03-17 Ntn Corp Hydraulic auto tensioner
WO2014200924A1 (en) * 2013-06-10 2014-12-18 Facet Technologies, Llc Lancet needle with alignment and retention notch
WO2015159845A1 (en) * 2014-04-16 2015-10-22 株式会社旭ポリスライダー Lancet

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JP2008017877A (en) * 2006-07-10 2008-01-31 Nippon Valqua Ind Ltd Puncturing body, puncturing device and blood sugar level measuring apparatus using puncturing body,

Patent Citations (1)

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JP2008017877A (en) * 2006-07-10 2008-01-31 Nippon Valqua Ind Ltd Puncturing body, puncturing device and blood sugar level measuring apparatus using puncturing body,

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9044177B2 (en) 2009-10-07 2015-06-02 Asahi Polyslider Company, Limited Lancet pricking device
EP2486852A4 (en) * 2009-10-07 2013-02-20 Asahi Polyslider Co Ltd Lancing device
US9693712B2 (en) 2009-10-07 2017-07-04 Asahi Polyslider Company, Limited Lancet pricking device
EP2486852A1 (en) * 2009-10-07 2012-08-15 Asahi Polyslider Co., Ltd. Lancing device
US9282919B2 (en) 2009-10-07 2016-03-15 Asahi Polyslider Company, Limited Lancet pricking device
WO2013110953A1 (en) * 2012-01-27 2013-08-01 Owen Mumford Limited Lancing device
JP2015508316A (en) * 2012-01-27 2015-03-19 オウエン マンフォード リミティド Puncture device
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
US10105079B2 (en) 2012-01-27 2018-10-23 Owen Mumford Limited Lancing device
JP2014047823A (en) * 2012-08-30 2014-03-17 Ntn Corp Hydraulic auto tensioner
WO2014200924A1 (en) * 2013-06-10 2014-12-18 Facet Technologies, Llc Lancet needle with alignment and retention notch
US10631770B2 (en) 2013-06-10 2020-04-28 Facet Technologies, Llc Lancet needle with alignment and retention notch
WO2015159845A1 (en) * 2014-04-16 2015-10-22 株式会社旭ポリスライダー Lancet

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