WO2012046851A1 - 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 - Google Patents
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 Download PDFInfo
- Publication number
- WO2012046851A1 WO2012046851A1 PCT/JP2011/073246 JP2011073246W WO2012046851A1 WO 2012046851 A1 WO2012046851 A1 WO 2012046851A1 JP 2011073246 W JP2011073246 W JP 2011073246W WO 2012046851 A1 WO2012046851 A1 WO 2012046851A1
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- WIPO (PCT)
- Prior art keywords
- lancet
- protective cover
- plunger
- injector
- puncture
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
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- 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
- A61B5/150175—Adjustment of penetration depth
- A61B5/15019—Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—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
- A61B5/15058—Joining techniques used for protective means
- A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
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- 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
- A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
- A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
- A61B5/150648—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
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- 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
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- 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
- A61B5/150885—Preventing re-use
- A61B5/150916—Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- 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
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- 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 puncture device used to puncture a predetermined part of the body with a puncture member having a sharp tip, for example, a needle, and a lancet assembly and an injector assembly constituting the puncture device in order to collect body fluid such as blood. .
- Such a device is composed of a lancet and an injector, and a lancet having a puncture member that punctures a predetermined part of the body is incorporated into an injector that fires such a lancet toward the predetermined part, and a spring compressed in the injector It is used by launching the lancet toward a predetermined location by utilizing the action of stretching.
- the tip of the puncture member is usually exposed from the lancet body with a small amount of blood collected by the blood sampler. For example, if a part of the body of a person other than the blood sample person (for example, a nurse who performs blood collection work) is accidentally touched to the tip part, the tip part may hurt that part and the blood sample from the wound may be removed. There is a risk that blood will enter the body of a person other than the blood sample and as a result, the person will be infected.
- the problem to be solved by the present invention is that, after puncturing, the tip of the puncture member remains protruding from the lancet body and is not removed from the injector, but the protruding tip is made as possible as possible from its periphery. It is intended to provide a puncture device that can be removed from an injector after being isolated.
- the present invention provides: (A) a lancet assembly having a lancet and a protective cover; and (b) an injector body having an injector body and a plunger and a pusher disposed therein, and having an injector assembly for firing the lancet body.
- a puncture device (1) The lancet has a lancet body, a lancet cap, and a puncture member, the puncture member is present in the lancet body and the lancet cap, and the tip of the puncture member is surrounded by the lancet cap.
- the protective cover is arranged around the front portion of the lancet body and the rear portion of the lancet cap, and after puncturing in a state where a predetermined portion to be punctured is pressed against the front end opening of the protective cover, the puncture member Can move forward along (3)
- the plunger grips or chucks or grips) the rear end portion of the lancet body (so as to sandwich the lancet body from the opposite direction), and the protruding distal end portion of the puncture member punctures a predetermined location.
- the pusher moves the protective cover forward along the puncture member by pushing the protective cover forward against the lancet body in a state where the rear end of the lancet body is gripped by the plunger.
- a puncture device is provided.
- the pusher is applied to the lancet body gripped by the plunger after abutment against the rear end of the protective cover by applying a force to push it forward.
- the protective cover By pushing the protective cover forward, the protective cover is pushed forward with respect to the lancet body and moved forward along the puncture member.
- the tip of the protruding puncture member is further rearward from the front end opening of the protective cover. (As a result, the distal end portion of the puncture member is further separated as much as possible), and then the pusher releases the lancet body from the plunger by a forward force of the protective cover.
- the pusher pushes the protective cover forward with respect to the lancet body by the forward pushing force applied to the pusher in a state where the plunger is prevented from moving forward, and moves forward along the puncture member. Move to.
- the lancet body has a protruding portion located in front of the rear end portion of the protective cover and a protruding portion located in the rear, and the rear portion of the protective cover moved forward.
- the projecting portion located in front of the rear end portion of the protective cover is fitted into the opening provided on the side. After the fitting, the lancet body held by the plunger is released.
- the plunger of the injector assembly grips the rear end portion of the lancet body so as to sandwich the lancet body from the opposite direction (for example, its up-down direction or left-right direction).
- the plunger has two opposing arms, and at least one of them is elastically deformed outward to release the lancet body.
- the lancing device of the present invention has a sliding guide that interlocks with the pusher, which allows for elastic deformation of the plunger.
- the injector assembly of the puncture device has a sliding guide that interlocks with the pusher. After the puncture, the pusher moves the protective cover forward along the puncture member with respect to the lancet body. Thus, after the protrusion of the lancet body is fitted into the opening of the protective cover, the sliding guide allows at least one arm of the plunger to spread outward. As a result, the gripped lancet body is released from the plunger.
- the features of the puncture device of the present invention as described above also apply to the lancet assembly and injector assembly of the present invention.
- the present invention provides: A lancet assembly comprising a lancet and a protective cover and loaded into an injector comprising a plunger and a pusher, (1)
- the lancet has a lancet body, a lancet cap, and a puncture member, the puncture member is present in the lancet body and the lancet cap, and the tip of the puncture member is surrounded by the lancet cap.
- the protective cover is arranged around the front part of the lancet body and the rear part of the lancet cap, and has an opening at the front end for pressing a predetermined portion to be punctured, and after puncturing by the injector, A lancet assembly is provided that moves forward along a puncture member by being pushed by a pusher while a rear end portion of the lancet body is gripped by a plunger.
- the present invention provides: An injector assembly that has an injector body and a plunger and a pusher disposed therein, the front portion is surrounded by a protective cover, and the lancet body is projected with the tip of the puncture member protruding. And (1) The plunger holds (or chucks) the rear end of the lancet body (so as to sandwich the lancet body from opposite directions), and the lancet so that the tip of the protruding puncture member punctures a predetermined location. Fire the body, (2) After the puncture, the pusher is moved forward along the puncture member by pushing the protective cover forward against the lancet body with the rear end of the lancet body held by the plunger. (3) The injector body includes a holding member that positions the protective cover so that the front end opening of the protective cover is positioned forward of the front end of the injector body at the time of puncturing. To do.
- front and rear directions considered in the description are based on the direction of launching the lancet, that is, the direction in which the lancet moves.
- front when referring to the direction in which the lancet moves for puncturing (thus, the direction in which the exposed tip of the puncture member moves toward the predetermined puncture site), “front”, “forward” or “forward”
- rear when referring to the opposite direction.
- up” and “down” and “right” and “left” are directions perpendicular to the above “front” and “rear”, and are used with reference to the direction shown in FIG. .
- the puncture device of the present invention when used, when the lancet is removed from the injector assembly after puncture, the tip of the puncture member protruding from the lancet body is surrounded by the protective cover in a state sufficiently positioned behind the front end opening. Therefore, it becomes possible to handle a lancet in a more secure state.
- a predetermined portion to be punctured (that is, a predetermined portion of puncture) is pressed against the front end opening of the protective cover, so that exuded blood adheres to the inside of the front end of the injector body.
- the possibility of doing is greatly reduced. If the exuded blood adheres, the adhering part may be near the inside of the front end of the protective cover.
- the protective cover can be moved so as to be positioned around the tip of the puncture member protruding forward from the lancet body, and then removed from the injector assembly and discarded. The occurrence of such problems can be minimized.
- a predetermined location to be punctured can be pressed against the front end opening of the protective cover, a special attachment should be used even when a puncture wound is formed in a relatively large location such as a palm.
- the protective cover is formed of a transparent plastic material, it is advantageous because it is easier to focus on the point to be punctured because the portion to be punctured and its periphery can be seen through the protective cover.
- the pain felt is generally smaller than when the fingertip is punctured, and when blood is collected after knowing it, the tension of the blood sample related to feeling the pain is relieved.
- the protective cover is transparent, the state of bleeding from the puncture site (for example, the palm) can be confirmed via the protective cover while the protective cover presses the puncture site. If the amount of bleeding is insufficient, the amount of bleeding can be increased by increasing the force with which the protective cover is pressed against the blood collection site.
- the protective cover is not transparent, it is necessary to remove the protective cover that presses the puncture site from the puncture site to check the amount of blood in a state where the amount of bleeding is unknown. It is necessary to position the protective cover so as to be positioned and press it again, but such positioning is not easy. In some cases, if it takes time to check the amount of bleeding and the subsequent positioning, the amount of bleeding does not increase even when pressed again, and it may be necessary to puncture again. If the protective cover is transparent, the need to puncture again can be reduced as much as possible. In this sense, the protective cover is preferably transparent in the present invention. In particular, when collecting blood from the palm, the amount of bleeding is generally small, and thus a transparent protective cover is particularly useful.
- FIG. 1 is a perspective view of a lancet assembly that can be used in the lancing device of the present invention.
- FIG. 2 is a perspective view schematically showing a state in which the upper half of the front half of the lancet assembly of FIG. 1 is cut away.
- FIG. 3 is a perspective view schematically showing the lancet constituting the lancet assembly of the present invention.
- FIG. 4 schematically shows a protective cover constituting the lancet assembly of the present invention in a perspective view. The state of the lancet assembly after the puncture and the protective cover has moved forward is schematically shown in a perspective view.
- FIG. 6 is a perspective view schematically showing a state in which the upper half of the front half of the lancet assembly of FIG. 5 is cut away.
- FIG. 7 schematically shows an external view of an injector assembly that can be used in the puncture device of the present invention.
- FIG. 8 is a perspective view schematically showing a body half constituting an injector body of the injector assembly.
- FIG. 9 schematically shows a perspective view in which the body half in front of the injector assembly shown in FIG. 7 is removed so that the inside can be seen. However, the injector body, the protective cover, the holding member, the combination of the plunger and the pusher, and the push button are shown in a state where the front half is cut away.
- FIG. 10 schematically shows a holding member fitted in the front end portion of the injector body in a perspective view.
- FIG. 11 schematically shows the depth adjusting member in a perspective view in a state in which a half on the near side is cut away.
- FIG. 12 schematically shows a perspective view of the plunger.
- FIG. 13 schematically shows a perspective view of the pusher.
- FIG. 14 is a perspective view schematically showing a state where the plunger and the pusher are combined in the injector body.
- FIG. 15 is a schematic perspective view, similar to FIG. 9, showing a state in which the lancet assembly is inserted into the injector assembly and the rear end portion of the lancet body approaches between the arms of the plunger.
- FIG. 16 is a schematic perspective view showing a state where the rear end portion of the lancet body is completely gripped between the arms of the plunger, similarly to FIG. FIG.
- FIG. 17 is a schematic perspective view showing a state in which the plunger moves backward from the state of FIG. 16 and the protrusion of the plunger is located behind the trigger member, as in FIG.
- FIG. 18 shows a state where the force for inserting the lancet assembly is released from the state shown in FIG. 17 and the projection of the plunger is in contact with the projection provided at the rear end of the trigger member, that is, the lancet assembly is loaded.
- the completed state is shown in a schematic perspective view as in FIG.
- FIG. 19 shows a state in which the lancet cap is removed by twisting in the lancet assembly, and the state in which the lancet is ready for launching is shown in a schematic perspective view as in FIG. FIG.
- FIG. 20 is a schematic perspective view showing the state at the moment when the lancet is fired by pressing the press button, as in FIG.
- FIG. 21 is a schematic perspective view showing a state where the lancet is fired and the tip of the puncture member protrudes from the opening of the injector assembly, that is, a state where a predetermined portion is punctured, as in FIG. Show.
- FIG. 22 is a schematic perspective view showing the state after the puncture is completed and the lancet is retracted, as in FIG. 9.
- FIG. 23 shows a state in which the pusher button is pushed forward and the arm of the pusher is in contact with the rear end of the protective cover in order to move the protective cover forward with respect to the lancet body that has been punctured.
- FIG. 24 shows a state in which the push button is pushed further forward from the state of FIG. 23 to move the protective cover forward, whereby the protruding portion of the lancet body is fitted into the opening of the protective cover.
- FIG. 25 is a schematic perspective view of the state in which the front end portion of the plunger arm releases the rear end portion of the lancet body by pushing the push button further forward from the state of FIG. Show. 26, when the push button is pushed further forward from the state of FIG.
- FIG. 23 is a schematic perspective view showing a state in which the lancet body surrounded by the protective cover jumps out from the front end opening of the injector assembly while being located at a sufficiently deep location.
- FIG. 27 shows the state of FIG. 24 in a schematic perspective view, similar to FIG.
- FIG. 28 is a schematic perspective view showing the front portion of the injector assembly in FIG. 19 so that the details of the inside thereof can be understood.
- FIG. 29 shows a state between the state of FIG. 23 and the state of FIG. 24 in a schematic perspective view as in FIG.
- the puncture member is generally made of metal (for example, stainless steel) and generates energy for moving the lancet before and after puncture.
- the spring (or spring) may be made of any suitable material, for example made of plastic, preferably metal, and the other parts being made of any suitable plastic material. Preferably, usually it is.
- the puncture member is made of metal (for example, a metal needle)
- the spring is also made of metal (for example, a coil spring)
- the other members are made of a suitable plastic material (for example, a molded product).
- the plastic material is usually formed by injection molding so as to have a predetermined structure.
- Usable plastic materials are, for example, low density polyethylene resin (LDPE), high density polyethylene resin (HDPE), polypropylene resin (PP), etc. for the lancet, and for example, polycarbonate resin (PC) for the injector assembly and protective cover.
- LDPE low density polyethylene resin
- HDPE high density polyethylene resin
- PP polypropylene resin
- PC polycarbonate resin
- ABS Acrylonitrile-butadiene-styrene copolymer resin
- POM polyacetal resin
- PS polystyrene resin
- FIG. 1 is a perspective view of a lancet assembly that can be used with the puncture device of the present invention
- FIG. 2 is a diagram showing 90 ° around the longitudinal axis of the lancet assembly (ie, in the front half of FIG. 1). This is schematically shown in a perspective view with the upper half) cut off.
- the illustrated lancet assembly 100 includes a lancet 101 and a protective cover 102.
- FIG. 3 schematically shows a lancet 101 constituting the lancet assembly of the present invention in a perspective view.
- the lancet 101 includes a lancet body 104 and a lancet cap 106.
- a puncture member 105 having a tip for puncturing a predetermined portion is embedded in the lancet, and the tip is inside the lancet cap 106 and the other part is inside the lancet body 104.
- FIG. 1 and 2 show a state in which the protective cover 102 is disposed around the lancet body 104 of the lancet 101, more specifically, around the front portion 114 of the lancet body and the rear portion 107 of the lancet cap. ing.
- FIG. 4 is a perspective view schematically showing the protective cover 102 constituting the lancet assembly of the present invention.
- the direction indicated by the arrow A is directed to the firing direction of the lancet, that is, forward.
- the rear end portion 116 of the lancet body 104 of the lancet is opposite to the arrow A from the opening 123 (not visible in FIG. 3) of the front end portion of the protective cover 102. It can be formed by inserting in the direction.
- the lancet assembly 100 including the lancet 101 and the protective cover 102 is charged by being inserted into the injector assembly that launches the lancet in the state shown in FIG. 1, and then the distal end portion 124 of the puncture member 105 is exposed.
- the protective cover 102 is moved forward relative to the lancet body 104 (as compared to FIGS. 1 and 2). it can. 5 and 6 show that the tip of the puncture member 105 is exposed, the lancet cap 106 has been removed, and the position of the protective cover 102 has moved forward.
- it differs from the state shown in FIG. 1 and FIG. 2 by the point which the protrusion part 122 fits into the opening part 125 so that it may mention later, it is not substantially different about others.
- the lancet body 104 and the lancet cap 106 are integrally coupled by a weakened portion 108 located between them.
- This weakened portion can be broken and pulled apart by turning the lancet body 104 and the lancet cap 106 in the opposite directions around the puncture member 105, i.e., so-called twist-off.
- Such a lancet is preferably integrally formed by injection molding of the plastic material with the puncture member 105 inserted in advance into the mold, that is, by insert molding, and the weakened portion is formed by the puncture member at that location. It can be formed by reducing the thickness of the surrounding plastic material.
- the lancet cap 106 has a tab element 110 so that it can be easily rotated by being pinched with fingers. This may for example be a flat spreading part. In the illustrated embodiment, such a portion is provided in the front portion of the lancet cap 106.
- a contact element 112 is provided at an intermediate portion of the lancet cap 106. This may be in the form of a protrusion that extends outwardly from the lancet cap body, for example in the form of a flange.
- the abutment element 112 inserts the lancet body 104 through the opening 123 at the front end of the protective cover 102, and the rear of the lancet body 104, particularly its front portion 114 and the lancet cap.
- the protective cover 102 When the protective cover 102 is disposed around the portion 107, the protective cover 102 can act as a stop, and the front end 121 of the protective cover 102 comes into contact with the contact element 112, so that the protective cover 102 cannot enter further forward.
- the body 104 cannot be inserted any further.
- the rear end portion 116 of the lancet body 104 can be positioned between the opposing arms of the plunger of the injector assembly, and a protrusion 118 provided on the rear end portion 116 is sandwiched by a recess provided on the inner side of the arm. To be gripped. By gripping the protrusion 118 in this manner, the lancet is reliably held by the plunger in the injector assembly.
- the front portion 114 of the lancet body has a protrusion 120 at the rear end thereof, and also has another protrusion 122 at the front portion. These spaced protrusions 120 and 122 are located between them when the protective cover 102 is placed around the front portion 114 of the lancet body 104 and the rear portion 107 of the lancet cap, as shown in FIGS. By positioning the rear end portion 150 of the protective cover, the protective cover 102 is positioned with respect to the lancet 101.
- the lancet 101 When the lancet 101 is inserted into the protective cover 102 and the protective cover is moved forward when the lancet assembly 100 is configured, such a protruding portion 120 is formed after the rear end portion 150 of the protective cover gets over the protruding portion 120.
- the lancet cap abutment element 112 is preferably configured to abut against the front end 121 of the protective cover immediately after.
- the cross section along the axial direction of the puncture member of the projecting portion 120 has a tapered shape that spreads outward toward the front, as shown in FIG.
- the protrusion 120 is preferably movable so as to approach the puncture member.
- the projecting portion 120 is separated from the main body of the front portion 114 of the lancet body 104 with a space portion 119 therebetween (for example, the rear end portion of the protective cover tries to get over the projecting portion 120).
- the protrusion 120 can be moved inward (ie, displaced toward the puncture member).
- the space portion 119 is formed by the protruding portion and the thin sheet-like portion 115 extending forward from the front end portion thereof. It is only necessary that the protruding portion can move inward, and the space portion is not necessarily required. For example, it may be movable by deformation utilizing the elasticity of the plastic material.
- FIG. 2 shows a state.
- the rear end portion of the protective cover abuts on the front end surface 117 of the protruding portion 120.
- the front end surface 117 preferably extends perpendicularly to the axial direction of the puncture member. Therefore, even if the protective cover is moved rearward, the rear end portion 150 of the protective cover is protruded 120. Can not be substantially overcome. Even if the protective cover is to be moved forward, the protective cover cannot be moved forward because the front end 121 of the protective cover comes into contact with the contact element 112. Therefore, the lancet and the protective cover are positioned according to the positional relationship shown in FIG.
- the protruding portion 120 is positioned in front of the rear end portion 150 of the protective cover 102. If the plunger of the injector assembly releases the lancet body in that state, the lancet body will come out of the front end opening of the protective cover, and the lancet will be exposed from the front end of the lancet body. The body comes out of the protective cover and is separated. In order to prevent such separation, another protruding portion 122 that is spaced forward from the protruding portion 120 ensures that the lancet body is held in the protective cover.
- the protective cover 102 is moved forward so that the rear end portion 150 is positioned in front of the protruding portion 120, and as a result, the protruding portion 122 fits into the opening 125 provided in front of the rear end portion 150.
- the protruding portion 122 fits into the opening 125 provided in front of the rear end portion 150.
- the distance between the two projecting portions 122 facing each other through the puncture member (that is, the distance between the outermost points of the projecting portions 122) is slightly larger than the inner diameter of the protective cover in the opening 125, and as a result When the portion 122 is once fitted into the opening 125, the protruding portion can be prevented from getting over as described above by being configured to slightly protrude into the opening. As will be described later, during puncturing, the protrusion 122 moves forward in a space defined by the protective cover having an inner diameter sufficiently larger than the inner diameter in the vicinity of the opening. This distance does not interfere with the puncture.
- four protrusions 122 are provided at equal angles around the puncture member (that is, at intervals of 90 °), and four openings 125 are provided at equal intervals so as to correspond thereto.
- the protective cover 102 moves forward with respect to the lancet body 104 to be in the positional relationship shown in FIGS. 5 and 6, and such a positional relationship is not substantially changed. ing.
- the protrusion 122 in front of the lancet body is fitted into the opening 125 provided at the rear end of the protective cover 102, and in such a state, the protrusion 122 is in contact with the lancet body 104. Although it can move within the opening 125, it is structured to prevent further movement.
- two rear protrusions 120 are arranged so as to face each other through the puncture member on the side surface of the front portion 114 of the lancet body 104 (ie, symmetrically with respect to the puncture member).
- four protrusions 122 on the front side are arranged every 90 °.
- four rear protrusions may be provided.
- two front protrusions may be provided.
- the protective cover 102 moves forward to completely cover the exposed distal end portion 124 of the puncture member, and then the leading edge 126 is further rearward from the front end surface of the protective cover 102 as shown in FIGS. 6, the projecting portion 122 fits into the opening 125 provided on the rear side surface of the protective cover 102, and as a result, in the state shown in FIGS. 5 and 6, the protective cover 102 is moved to the lancet body 104. Even when a force for retreating is applied, the retraction is designed to be prevented by such fitting.
- the opening 125 of the protective cover 102 and the protrusion 122 of the lancet body 104 cooperate to prevent the protective cover 102 from moving backward.
- the protrusion 122 at least partially has a taper that slightly extends forward as shown. It preferably has a surface 130 having a surface, and has a surface 132 that is steep, preferably substantially perpendicular to the side of the protective cover 102, to prevent the protective cover 102 from returning once it has been overcome.
- Such a protrusion 122 functions as a return prevention protrusion.
- the protrusion 122 preferably protrudes outward at an appropriate location on the front portion 114 of the lancet body, as shown in FIG. 3 (or FIG. 28).
- the protruding portion is formed so that the cross section in the direction perpendicular to the puncture member has a T-shape constituted by the “-” portion and the “I” portion, and the “I” portion faces outward.
- the protrusion 122 may be configured such that the "-" portion is formed in a wing shape at the tip thereof, and the wing-shaped portion particularly has the tapered surface 130 that extends forward as described above. preferable.
- FIG. 7 schematically shows an external view of an injector assembly 200 that can be used in the puncture device of the present invention in a perspective view
- FIG. 9 shows the internal state of the front half of the injector assembly shown in FIG.
- the perspective view thus made is schematically shown together with the lancet assembly in the state of FIG. 1 (where the front half of the protective cover is cut off).
- This state is a state in which the lancet assembly is waiting to be loaded, that is, a standby state.
- the lancet assembly 100 is moved with respect to the injector assembly 200 in the direction of arrow a shown in FIG. Load the lancet assembly by inserting.
- the injector assembly 200 of the present invention includes an injector body 202 and a plunger 204 (FIG. 12) and a pusher 206 (FIG. 13) disposed therein.
- This injector assembly can be loaded with the lancet assembly 100 having the above-described protective cover, and fire the lancet body with the tip of the puncture member exposed.
- the injector body 202 is composed of a pair of body halves 210 and 210 '(see FIG. 8).
- the injector assembly 200 has an opening 214 at the front end for inserting the lancet assembly at the time of puncturing. More specifically, the opening 214 is defined by a holding member 215 fitted in the front end portion of the injector body 202.
- the holding member 215 is schematically shown in a perspective view in FIG.
- the holding member 215 is a cylindrical member as a whole having the opening 214.
- On the inside of the tube there is a protrusion 219 behind the opening, preferably a gentle ridge.
- the protrusions 219 are formed in one pair vertically or horizontally, or two pairs vertically or horizontally. In another aspect, protrusions may be formed at three or more locations.
- the protrusion 219 is configured so that the protective cover is tightly held by the protrusion when inserted through the opening 214 to load the lancet assembly into the injector assembly.
- Such tight holding forms the protective cover and the protrusion so that they are just in contact with or close to each other, and the protective cover has dimensions that allow it to move back and forth in that state.
- the protective cover is movably fitted between the plurality of protrusions by a weak press fit (or press-fitting) (thus, the protrusions sandwich or hold the protective cover). Has been.
- the protective cover By placing the holding member in the injector body in this way, when the lancet assembly is loaded into the injector body, the protective cover has an injector assembly so that the opening of the front end is positioned forward of the front end of the injector assembly, More specifically, it is held in a predetermined manner in cooperation with the holding member.
- the holding member is preferably provided with a plurality of other protrusions 290 in addition to the protrusion 219 described above.
- This protrusion is configured to prevent the protective cover from rotating about the insertion direction when inserted rearwardly through the opening 214 to load the lancet assembly into the injector assembly. That is, the protrusion 290 provides a guide for inserting the lancet assembly so as not to rotate.
- Such rotation prevention can be implemented by forming the outer shape of the protective cover and the shape perpendicular to the insertion direction of the protrusion 290 so as to be complementary to each other.
- a concave portion may be formed on the outer side of the protective cover, and a convex portion (for example, the protruding portion 290) that fits into the concave portion may be formed on the inner side of the holding member.
- the protrusions 290 are arranged to face each other with a protective cover interposed therebetween.
- the protrusions 290 are positioned, for example, on the upper and lower sides and / or the left and right sides of the protective cover.
- the protrusions 290 are arranged so as to be positioned every 120 ° around the protective cover. In the illustrated embodiment, four positions are provided every 90 ° around the opening. In still another embodiment, the two positions may be provided every 180 °.
- the protrusions are not necessarily all in the same form (for example, one may be circumferential and the other one or more may be dot-like), and in the insertion direction of the lancet assembly. An elongated protrusion may extend along.
- the holding member 215 has a protruding portion pushing means 221 at the rear portion thereof.
- This means may take any form as long as the means can push the protrusion 120 at the rear of the lancet body 104 inward when the lancet assembly is inserted.
- the size of the opening at the rear end of the holding member is set such that the wall forming the opening is in contact with the upper and lower sides of the lancet body 104 or is located with a slight gap therebetween. To do.
- the lancet body is inserted in contact with or close to the wall forming the opening, and when the protrusion 120 reaches the opening, the wall defining the opening contacts the protrusion 120, Thereafter, when the insertion is continued, an inward force is applied to the protrusion 120 by the wall, so that the protrusion 120 is pushed inward.
- the projecting portion 120 can move forward from the rear end portion 150 of the protective cover.
- the injector assembly of the present invention is preferably capable of changing the puncture depth, and the mechanism itself is disclosed in, for example, WO 1997/004707 (Japanese Patent No. 3638958, US Pat. No. 5,730,753). The content of which is disclosed in this patent document and is incorporated herein by reference.
- an element corresponding to the member 281 in the illustrated embodiment
- An element that collides (an element provided in the injector body and functioning as a stopper, corresponding to the member 280 in the illustrated embodiment) is provided in the injector body.
- Such an element can change where the portion of the plunger collides along the puncture direction so that the plunger moves forward until the portion of the plunger collides. The distance can be changed, and as a result, the puncture depth can be changed.
- the puncture depth adjusting member 280 is arranged in the injector body, and the collision member 281 provided at the rear end of the plunger is configured to collide with the puncture depth adjusting member 280.
- a specific example of the depth adjusting member 280 is schematically shown in a perspective view in FIG.
- the depth adjustment member 280 has a generally cylindrical shape that is rotatably arranged around the plunger (shown in a state in which the front half is cut away in FIG. 11).
- the puncture depth adjusting member 280 has a plurality of steps 282 where the part of the plunger (or the element 281 provided on the plunger acting as the part) collides.
- Each step has a different position along the puncture direction, and the tip 279 of the collision member 281 is configured to collide with any one of the steps. Therefore, the step in which the part of the plunger collides can be changed variously. Varies the distance that the plunger can move, and as a result, the distance that the plunger moves forward changes.
- the plunger 204 holds the rear end portion 116 of the lancet body and fires the lancet body 104 from which the distal end portion 124 of the puncture member 105 protrudes forward so that the distal end portion 124 of the puncture member 105 punctures a predetermined location. It has the function to do. Note that after puncturing, the lancet body 104 from which the distal end portion 124 of the puncture member 105 protrudes also has a function of pulling back.
- the pusher 206 pushes the protective cover 102 disposed around the lancet body 104 that has been pulled back after puncturing forward with respect to the lancet body 104, so that the distal end portion 124 of the puncture member 105 that protrudes forward from the lancet body 104 is formed. It functions to move so as to be located further rearward from the front end of the protective cover. Thus, when the front end portion of the protective cover is located further rearward, the tip end portion of the puncture member is further isolated as much as possible from the periphery thereof.
- a holding member 215 is disposed around the front ends of a pair of body halves 210 and 210 'that are combined with each other (eg, by snap fit) and defining a space therein. .
- the plunger 204 and the pusher 208 are arranged in the space portion thus defined.
- FIG. 12 schematically shows a perspective view of the plunger 204
- FIG. 13 schematically shows a perspective view of the pusher 206.
- the rod-shaped portions 286 and 286 ′ of the pusher 206 are fitted into the spaces 285 and 285 ′ formed on both sides of the plunger main body 205 at the plunger projections 524, and these rod-shaped portions are planned.
- the jar body 205 is disposed in the injector assembly in a state of being combined so as to extend on both sides. The combined state is shown in FIG. 14 in a schematic perspective view.
- Pusher rod-like portions 286 and 286 ' are slidable longitudinally within plunger spaces 285 and 285'.
- the plunger 204 includes two opposing upper arms 228 and lower arms 230 that extend forward from the front end of the plunger body 205.
- Upper arm 228 and lower arm 230 of plunger 204 have recesses 241 and 239, respectively, at the front end.
- a part of the protruding portion 118 provided at the rear end portion 116 of the lancet body 104 is fitted between these concave portions. That is, such an arm, in particular its recess 239 and recess 241 constitute a chuck element.
- the shape of these recesses is preferably such that a part of the protrusion 118 is just fitted, that is, the recesses 239 and 241 and the protrusion 118 are complementary with respect to the cross-section along the longitudinal direction of the puncture member. Is preferred.
- the plungers are made of a plastic material, they can open elastically when a force is applied to spread the arms. By configuring the plunger in this way, the plunger can grip (or chuck) the la
- the rear end portion 116 of the lancet body 104 is inserted into the inside through the opening 214 of the injector assembly 200, and a plunger disposed therein. It moves toward 204.
- the rear end portion of the inserted lancet body 116 passes between the front end portion 264 of the arm 228 and the front end portion 266 of the arm 230, and a part of the rear end portion 116 of the lancet body 104 (provided there)
- the protruding portion 1118) spreads between the arms and then enters between the recess 239 and the recess 241.
- the arm returns to its original shape.
- the rear end portion 116 is sandwiched between the arms. In a state of being fitted, it is fitted into a space formed between them.
- the plunger may have two opposing arms as described above, preferably a generally U-shaped arm, but in another aspect, the plunger has a rear end of the lancet body. It may have more than two arms as long as it can be properly gripped. Accordingly, the plunger has at least two arms. For example, in the case of having two arms, the plunger can be gripped by pinching the rear end portion of the lancet body from the opposite direction (for example, the vertical direction) across the lancet body.
- the protrusion 118 at the rear end of the lancet body 104 may be in the form of a rim or a flange, for example, and may form the rear end of the lancet body 104 or may protrude from the side surface of the lancet body.
- the protrusion 108 is defined by a slope surface 140 (corresponding to the side surface of the truncated cone in the illustrated embodiment) that extends obliquely toward the rear end of the lancet body 104.
- the front end 264 and front end 266 of the arms 228 and 230 have surfaces 268 and 270 that widen in the direction of launch of the lancet, as shown in FIG. Complementary.
- the slope surface 140 that expands in the firing direction of the lancet is in the firing direction of the lancet.
- forces are applied to move the front ends 264 and 266 of the plunger arm upward and downward, respectively.
- the arm 228 and the arm 230 are integrated with the rear portion 226 of the plunger 204 at the rear end thereof, the front end portions 264 and 266 of the arm are about to move when the force described above is applied. And the arm 230 is elastically slightly curved outward (that is, spread outward). As a result, the space between the front end portions 264 and 266 widens, and the protrusion 118 of the lancet body 104 passes between the front end portions of the arms and fits into the recesses 239 and 241 positioned immediately after the front end portion.
- the front end 264 of the arm is provided in the injector body in order to enable temporary elastic bending of the arm as described above and to prevent elastic deformation after gripping.
- a guide for guiding the arm of the plunger in the longitudinal direction of the plunger having a recess corresponding to the upper and lower shapes of 266 and 266 or a recess capable of accommodating such upper and lower shapes in part. (Refer to FIG. 9, concave portions 506 and 508 of guides 507 and 509).
- the tip of the arm cannot move upward or downward.
- the upper shape portion 264 and lower side of the tip are not provided.
- the tip portion moves upward or downward (ie, spreads in the direction toward the upper or lower inner wall of the injector assembly) to allow elastic bending. It has become.
- a guide 507 disposed in the injector and having a function of guiding the longitudinal movement of the front end 264 of the arm 228 has a recess 506, and the front end 266 of the arm 230 disposed in the injector.
- a sliding guide 509 having a function of guiding the movement in the longitudinal direction has a recess 508.
- the lancet body is released from the plunger in a process reverse to the process of fitting the lancet body described above. That is, when a forward force is applied to the lancet body with respect to the plunger, the arm is used to bend and expand elastically outward. Again, at least one arm can be released by spreading outward. In the illustrated embodiment, when the lancet body is released, only the lower arm 230 is configured to bend outward substantially.
- a pusher 206 as shown in FIG. 13 is used in combination with the plunger 204 as described above.
- Pusher 206 comprises rod-like portions 286 and 286 'and a forward portion 250 comprised of arms 246 and arms 248 extending forwardly from its front end.
- the front portion 250 with arms 246 and 248 is generally U-shaped.
- the distal end portion of the pusher arm is branched so as to form a branched elongated long portion 245.
- the rod-shaped portions 286 and 286 ′ adjacent to the front portion 250 of the pusher 206 have a rectangular and constant shape over a relatively long distance from the front end to the rear (portion 252).
- a rod-shaped part is integrally connected (part 254), and has a protruding part at the rear end part (part 256).
- a portion (portion 252) having a rectangular cross section and a fixed shape can be moved back and forth, preferably slid, in spaces 285 and 285 'defined on the side of the plunger. This movement is hindered by the protrusion 247 (corresponding to the rear end face of the front portion 250) formed on the pusher coming into contact with the flange 249 formed on the plunger.
- the plunger can be moved back and forth and the pusher can be moved back and forth independently. That is, when a forward force is applied to the rear end portion 256 of the pusher, the pusher 206 can be moved forward without applying a force to the plunger 204. Further, when a forward or backward force is applied to the plunger 204, the pusher 206 is moved forward or backward without applying a force to the pusher 206 within a range where the protrusion 247 and the flange 249 do not contact each other. Is possible.
- the puncture device of the present invention is configured by loading the above-described lancet assembly of the present invention into the above-described injector assembly of the present invention. Accordingly, the lancet assembly of the present invention described above and the injector assembly of the present invention described above in a state before being loaded, that is, the lancet assembly of the present invention and the above-described lancet assembly in a state where they exist separately and are not combined.
- the injector assembly of the present invention constitutes a puncture device kit.
- the lancet assembly and the injector assembly described above are used to constitute the puncture device of the present invention to puncture a predetermined place, and then the used lancet is taken out from the injector assembly. A state is demonstrated in order.
- the lancet assembly 100 is loaded into the injector assembly 200 in the standby state shown in FIG. Specifically, as shown by an arrow a in FIG. 9, the rear end portion 116 of the lancet body 104 of the lancet assembly 100 is inserted from the opening 214 on the front end surface of the injector assembly 200.
- the protective cover 102 can pass rearward while contacting or close to the protrusion 219 provided behind the opening 214 of the holding member 215 provided at the front end of the injector body.
- the protrusion 290 of the holding member fits into the recess 160 provided in the protective cover, the lancet assembly 100 is configured so as not to rotate inside the holding member 215.
- the rear end 116 approaches the space between the front end 264 of the plunger arm 228 and the front end 266 of the arm 230, as shown in FIG. It abuts against the front ends 264 and 266 of the arm.
- the front ends 264 and 266 have slope surfaces 268 and 270 that widen in the direction of firing (or injection) of the lancet, and the shape of the slope surface is complementary to the slope surface 140 of the protrusion 118. Therefore, if the lancet assembly is further moved rearward after the contact, the arms 228 and 230 tend to spread outward.
- the inner wall part of the injector body is designed so that the outermost part of the front end of the arm slides with respect to the inner wall part, the action of spreading so is suppressed and only retreats.
- the concave portions 506 and 508 are provided in the inner wall portion, the front end portion slides and retreats, and at least a part thereof, for example, the outermost portion and the adjacent portion thereof are fitted into the concave portions 506 and 508. Only, the arm tries to spread outward by the depth of the recess.
- the rear end 116 moves further rearward by allowing the protrusion 118 provided at the rear end 116 of the lancet body to pass through the distance between the innermost portions of the front end of the arm due to this spread.
- the protrusion 118 provided at the rear end 116 is fitted between the recesses 239 and 241 at the arm front end.
- the surface which defines the recessed parts 239 and 241 is made complementary to the surface which defines the protruding part 118, so that the fitting of the protruding part 118 between the recessed parts 239 and 241 becomes tight.
- the injector assembly 200 is provided with a lever-like trigger member 514 that acts as a trigger for firing the lancet.
- the trigger member shaft portion 516 ′ (see FIG. 23) inserted into the hole 516 (see FIG. 8) and pivotally supported can be moved (rotated) as a fulcrum, and the rear end portion 542
- a compression spring 520 is provided between the inner wall 518 of the injector body above it.
- a compression spring 521 is disposed between the trigger and the inside of the injector near the front end of the trigger member.
- the trigger member is movable in a seesaw shape around the fulcrum 516, and an upward force is applied to the front end portion 543 by the spring 520 and the spring 521. The upward movement of the end portion is restricted.
- the protrusion 524 provided integrally therewith is also retracted together.
- the protrusion 524 initially has its upper portion in contact with the underside of the rear portion 527 of the trigger member 514, and then resists the acting downward force by compressing the springs 520 and 521, thereby causing the rear portion 527.
- FIG. 16 it is further retracted while an upward force is applied to (and hence the spring 520 is compressed).
- the protrusion 524 passes through the protrusion 526 provided at the rear end portion of the trigger member 514, the spring 520 is once greatly compressed, and immediately after that, the trigger member 514 returns to the original state (the state of FIG. 15),
- the protrusion 524 is located behind the protrusion 526 of the trigger member 514.
- FIG. 17 shows a state in which the protrusion 524 has passed through the protrusion 526 and the trigger member 514 has just returned to its original state.
- the rear protrusion 120 provided on the lancet body 104 is moved inward by the protrusion pushing means 221 provided in the injector body. It will be pushed into the state.
- the rear end portion of the holding member may constitute the protruding portion pushing means 221.
- a force sufficient to retract the plunger is applied as described above, and the lancet assembly is pushed backward, so that the protrusion 524 of the plunger is triggered as shown in FIG. Located behind the protrusion 526 of the member.
- FIG. 17 also shows a state in which the protruding portion 120 is pushed inward.
- the protrusion 526 provided on the trigger member is located in front of the protrusion 524, so that the protrusion 524 is prevented from moving forward. Is done.
- a protective cover fixing means is provided in the injector body so that the protective cover is securely held in the injector body.
- This fixing means may be any means that can fix the protective cover 102 to the lancet 101 when the trigger member returns to its original state.
- the columnar member 233 that partially fits inside the opening functions as a fixing means by being positioned over the opening 133 (see FIG. 4) of the protective cover.
- a spring S1 is disposed as an injection spring between the protrusion 524 and a stop 530 provided on the injector body around the plunger.
- This spring S1 is compressible.
- the length of the spring S ⁇ b> 1 that is, the distance between the protrusion 524 and the stop 530
- the spring S1 is held in a compressed state.
- a spring S2 is disposed as a return spring between the stopper 530 and a partition member 534 provided behind the rear end of the plunger, around the rear end of the plunger, behind the spring S1. .
- a spring S3 is disposed as a pushback spring between the push button 213 and the partition member 534.
- the partition member 534 is fixed in the injector body, and a collision member 281 that also functions as a spring holding member is fitted in the rear end portion of the plunger, and between this and the front end portion of the puncture depth adjusting member 280.
- a spring S2 is held around the plunger. Therefore, the degree to which the spring S2 is compressed changes depending on the position of the step 282 of the puncture depth adjusting member 280 where the collision member 281 collides.
- the spring S2 When the lancet is fired, the spring S2 is instantaneously compressed because the rear end of the plunger 204 moves forward, but then immediately extends toward the original length. Accordingly, the spring S2 acts to pull back the fired lancet backward. As will be described later, the spring S3 applies a force to move the pusher forward when moving the protective cover further forward around the tip of the puncture member protruding from the used lancet body. It has a function of returning the moved push button 213 to the rear. That is, it functions as a pushback spring.
- the plunger 204 is moved backward from the standby state shown in FIG. 9 (based on the injector body 202). Accordingly, the spring S2 is in a relatively extended state, and in the illustrated embodiment, it is in a substantially extended state.
- the lancet cap is rotated around the piercing member, that is, as shown by the arrow in FIG. This is done by breaking the weakened portion 108 of the lancet by twisting and then pulling the lancet cap 106 forward. That is, the lancet cap is twisted off.
- Fig. 19 shows the state where the lancet cap is being removed.
- the protective cover 102 is formed of the lancet body, for example, the protrusion 122 of the puncture member within the protective cover.
- An internal space that cannot be rotated around is formed.
- the protective cover has a groove-like space portion 141 parallel to the extending direction of the puncture member 105 in which the protrusion 122 (see FIG. 6) can move substantially only in the front-rear direction.
- a predetermined portion to be punctured for example, a fingertip
- a predetermined portion to be punctured for example, a fingertip
- the lancet body 104 from which the distal end portion 124 of the puncture member 105 is exposed moves forward in an instant, protrudes from the opening 123 of the protective cover and punctures a predetermined portion, and then moves in the opposite direction. Retract, and the plunger returns to the same position as in the standby state.
- FIG. 21 shows a state in which the distal end portion 124 of the puncture member has moved forward most (that is, a state in which the puncture is performed), and FIG. The state located in front of the protrusion 526 of 517 is shown. Thereafter, the process proceeds to a process of removing the used lancet body 104 from the injector assembly for disposal.
- a forward force is applied to the push button 213 as indicated by an arrow. Since the push button 213 is configured and connected so as to be able to push the rear end of the pusher 206, such a force moves the pusher 206 forward.
- the protrusion may be in contact with a protrusion, for example, the protrusion 157 located at the rear portion of the protective cover.
- FIG. 28 is a perspective view showing the front portion of the injector assembly in FIG. 19 in order to clarify the inside.
- the protective cover When the push button 213 is further pushed forward from the state of FIG. 23 to move the pusher 206 further forward, the protective cover further and slightly moves forward, but the rear end 150 of the protective cover is the lancet body. Since it abuts against the rear protrusion 120, a further force is required to push the protective cover forward in order to get over it. That is, the protrusion 120 becomes a resistance. At this time, since the used lancet body 104 remains gripped by the plunger, the lancet body, and thus the plunger that grips it, moves forward until a force sufficient to get over is applied. The puncture depth adjusting member 280 and the collision member 281 are brought into contact with each other (see FIG. 29 described later).
- the force applied to the protective cover acts so that it moves forward.
- the fixing means 233 comes out of the opening 133, and the rear end 150 of the protective cover gets over the protrusion 120 at the rear of the lancet body.
- the front wall 128 of the opening of the protective cover gets over the protrusion 122 on the front side of the lancet body. As a result, as shown in FIG. It fits into the opening 125 of the protective cover.
- the relationship between the lancet body and the protective cover is as shown in FIGS. That is, when the forward movement of the plunger 204 is prevented, the forward movement of the lancet body 104 is prevented, and when the push button 213 is further pushed forward in such a state, the rear end portion of the protective cover 102 A forward force acts on 150. Such a force causes only the protective cover 102 to move sufficiently forward, further forward along the peripheral portion of the tip of the protruding piercing member, and as shown in FIGS. 5 and 6
- the leading edge 126 of the puncture member is positioned sufficiently rearward from the front end surface of the protective cover 102. Accordingly, the protective cover 102 cannot substantially move forward or backward with respect to the lancet body 104 from this state.
- a force is applied to the rear end of the protective cover by the pusher until the protrusion 122 on the front side of the lancet body is fitted into the opening 125 of the protective cover (the state shown in FIG. 24).
- the plunger hardly moves forward until the protruding portion 122 is fitted, so that when the pusher is moved forward, the sliding guide is moved below the front end 266 of the plunger.
- the protrusion 511 is substantially always positioned to prevent bending of the lower arm of the plunger (ie, outward spreading), while the protrusion 511 is not present after being fitted.
- the sliding guide 509 and the flange portion (or protruding portion) 247 protruding below the pusher are interlocked.
- the flange (or protrusion) 247 contacts the rear of the rear protrusion 513 that defines the recess 508 of the sliding guide. Make contact.
- the flange portion 247 comes into contact with the protruding portion 513 and then the sliding guide 509 is moved forward, so that the front protruding portion 511 located below the front end portion 266 is moved. Does not exist by moving forward, and a recess 508 exists below the front end 266.
- the lower arm 230 of the plunger can be curved outward and expand, whereby the plunger is held by the lancet body. Release the rear end.
- the lancet body can be released from the gripped state by bending only the lower arm.
- the upper arm can be slightly curved.
- FIG. 25 shows a state in which the rear end portion 116 of the lancet body is released from the recesses 239 and 241 of the arm. Thereafter, by pulling out the protective cover, the lancet body around which the protective cover is disposed can be taken out from the injector assembly and appropriately disposed as prescribed.
- the opened lancet body and protective cover are automatically opened from the front end opening of the injector body as shown in FIG. Jump out.
- a spring S4 is arranged as a return spring between the rear end of the sliding guide 509 and a predetermined portion inside the injector, and the force applied to the pusher is released from the state where it is moved forward by the pusher as described above.
- the sliding guide is also returned to the original state by the spring S4.
- the pusher may have two opposing arms as described above, preferably a U-shaped arm as a whole (as shown), but in another aspect, a protective cap There may be more than two arms as long as the rear end can be pushed properly.
- the pusher therefore comprises at least two arms.
- the protective cover is disposed around the puncture member, and the most advanced portion of the puncture member is located sufficiently far from the front end surface of the protective cover 102, so that it has been used. Even when handling the lancet, the possibility of contact with the tip of the puncture member after puncture is greatly reduced.
- the operation of removing the lancet from the injector assembly after puncturing is performed by simply pushing the push button 213 without directly handling the lancet body as described above when using the lancet assembly of the present invention and the puncture device using the injector assembly. By pushing forward, it can be easily implemented by placing the protective cover at the tip of the protruding puncture member.
- the lancet assembly and injector assembly of the present invention provide a puncture device that can collect blood more safely.
- cantilever 233 ... Protective cover fixing means, 234 ... spring, 235 ... overhanging portion, 237 ... Step 239 ... Front end recess, 241 ... Front end recess, 243 ... fulcrum, 245 ... long part, 246 ... arm, 247 ... flange part, 248 ... arm, 249 ... flange, 250 ... front portion, 252, 254, 256 ... a part of the pusher, 264, 266 ... the front end of the arm, 268, 270 ... surface, 280 ... depth adjusting member, 281 ... collision member, 282 ... Step, 285.285 '... Space, 286, 286' ... Rod-shaped part, 290 ...
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- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
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- Pathology (AREA)
- Engineering & Computer Science (AREA)
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- Hematology (AREA)
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Abstract
Description
(a)ランセットおよび保護カバーを有して成るランセットアッセンブリ、ならびに
(b)インジェクターボディならびにその中に配置されたプランジャーおよびプッシャーを有して成り、ランセットボディを発射するインジェクターアッセンブリ
を有して成る穿刺デバイスであって、
(1)ランセットは、ランセットボディ、ランセットキャップおよび穿刺部材を有して成り、穿刺部材は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これらの中に存在し、穿刺部材の先端部はランセットキャップによって包囲され、
(2)保護カバーは、ランセットボディの前方部分およびランセットキャップの後方部分の周囲に配置され、また、保護カバーの前端開口部に穿刺すべき所定箇所を押し当てた状態で穿刺した後、穿刺部材に沿って前方に移動でき、
(3)プランジャーは、ランセットボディの後端部を(それを隔てて対向する方向から挟むように)把持(またはチャックもしくは握時)し、突出した穿刺部材の先端部が所定箇所を穿刺するようにランセットボディを発射し、
(4)プッシャーは、穿刺後、ランセットボディの後端部がプランジャーに把持された状態で、保護カバーを、ランセットボディに対して前方に押して、穿刺部材に沿って前方に移動させることを特徴とする穿刺デバイスを提供する。
上述のような本発明の穿刺デバイスの特徴は、本発明の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にも当て嵌まる。
ランセットおよび保護カバーを有して成り、プランジャーおよびプッシャーを有して成るインジェクターに装填されるランセットアッセンブリであって、
(1)ランセットは、ランセットボディ、ランセットキャップおよび穿刺部材を有して成り、穿刺部材は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これらの中に存在し、穿刺部材の先端部はランセットキャップによって包囲され、
(2)保護カバーは、ランセットボディの前方部分およびランセットキャップの後方部分の周囲に配置され、また、穿刺すべき所定箇所を押し当てる開口部を前端に有し、インジェクターによる穿刺後にあっては、ランセットボディの後端部がプランジャーに握持された状態で、プッシャーによって押されることによって穿刺部材に沿って前方に移動する
ことを特徴とするランセットアッセンブリを提供する。
インジェクターボディならびにその中に配置されたプランジャーおよびプッシャーを有して成り、前方部分が保護カバーによって包囲され、また、穿刺部材の先端部が突出した状態にあるランセットボディを発射するインジェクターアッセンブリであって、
(1)プランジャーは、ランセットボディの後端部を(それを隔てて対向する方向から挟むように)把持(またはチャック)し、突出した穿刺部材の先端部が所定箇所を穿刺するようにランセットボディを発射し、
(2)プッシャーは、穿刺後、ランセットボディの後端部がプランジャーに把持された状態で、保護カバーをランセットボディに対して前方に押して穿刺部材に沿って前方に移動させ、
(3)インジェクターボディは、穿刺に際して、保護カバーの前端開口部がインジェクターボディの前端よりも前方に位置した状態となるように保護カバーを位置決めする保持部材を有する
ことを特徴とするインジェクターアッセンブリを提供する。
利点もある。
104…ランセットボディ、105…穿刺部材、106…ランセットキャップ、
108…弱化部分、110…タブ要素、112…当接要素、114…前方部分、
115…シート状部、116…後端部、118…突出部、119…空間部、
120…突出部、121…前端部、122…突出部、
123…保護カバーの前端開口部、124…穿刺部材先端部、125…開口部、
126…穿刺部材最先端、127…開口部後壁、128…開口部前壁、
130…テーパー面、131…突出部、132…急峻面、133…開口部、
139…隙間、140…スロープ面、141…溝状空間部、150…後端部、
157…突出部、160…凹部、200…インジェクターアッセンブリ、
202…インジェクターボディ、204…プランジャー、
205…プランジャー本体、206…プッシャー、
210,210’…ボディハーフ、213…プッシュボタン、
214…開口部、215…保持部材、219…突出部、
221…突出部押し込み手段、226…後方部分、228…上方アーム、
230…下方アーム、232…カンチレバー、
233…保護カバー固定手段、234…バネ、235…張り出し部、
237…ステップ、239…前方端部凹部、241…前方端部凹部、
243…支点、245…長尺部分、246…アーム、247…フランジ部、
248…アーム、249…フランジ部、250…前方部分、
252,254,256…プッシャーの一部、264,266…アームの前端部、
268,270…面、280…深さ調節部材、281…衝突部材、
282…ステップ、285.285’…空間、286、286’…ロッド状部分、
290…突出部、506…凹部、507…ガイド、508…凹部、
509…スライディングガイド、511,513…突出部、514…トリガー部材、
515…インジェクターボディの内壁部、516…支点、518…内壁部、
520,521…バネ、524,526…突起、527…後方部分、530…止め、
534…仕切部材、542…端部分、543…前方端部分、
S1…インジェクションスプリング、S2…リターンスプリング、
S3…プッシュバックスプリング、S4…リターンスプリング。
Claims (14)
- (a)ランセットおよび保護カバーを有して成るランセットアッセンブリ、ならびに
(b)インジェクターボディならびにその中に配置されたプランジャーおよびプッシャーを有して成り、ランセットボディを発射するインジェクターアッセンブリ
を有して成る穿刺デバイスであって、
(1)ランセットは、ランセットボディ、ランセットキャップおよび穿刺部材を有して成り、穿刺部材は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これらの中に存在し、穿刺部材の先端部はランセットキャップによって包囲され、
(2)保護カバーは、ランセットボディの前方部分およびランセットキャップの後方部分の周囲に配置され、また、保護カバーの前端開口部に所定箇所を押し当てた状態で穿刺した後、穿刺部材に沿って前方に移動でき、
(3)プランジャーは、ランセットボディの後端部を把持し、突出した穿刺部材の先端部が所定箇所を穿刺するようにランセットボディを発射し、
(4)プッシャーは、穿刺後、ランセットボディの後端部がプランジャーに把持された状態で、保護カバーをランセットボディに対して前方に押して、穿刺部材に沿って前方に移動させることを特徴とする穿刺デバイス。 - プッシャーがランセットボディの周囲に配置された保護カバーを前方に押すために、プッシャーをプランジャーに対して前方に移動させる時、プランジャーの前方への移動が阻止されるようになっている
ことを特徴とする請求項1に記載の穿刺デバイス。 - プランジャーは、少なくとも2つのアームを有して成る前方部分を有して成り、
アームの前端部は、ランセットボディの後方部分を把持するチャック要素を構成する
ことを特徴とする請求項1または2に記載の穿刺デバイス。 - プッシャーは、少なくとも2つのアームを有して成る前方部分を有して成り、
アームの前端部は、保護カバーの後端を押して保護カバーを前方に移動させることができる
ことを特徴とする請求項1~3のいずれかに記載の穿刺デバイス。 - ランセットおよび保護カバーを有して成り、プランジャーおよびプッシャーを有して成るインジェクターに装填されるランセットアッセンブリであって、
(1)ランセットは、ランセットボディ、ランセットキャップおよび穿刺部材を有して成り、穿刺部材は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これらの中に存在し、穿刺部材の先端部はランセットキャップによって包囲され、
(2)保護カバーは、ランセットボディの前方部分およびランセットキャップの後方部分の周囲に配置され、また、穿刺すべき所定箇所を押し当てる開口部を前端に有し、インジェクターによる穿刺後にあっては、ランセットボディの後端部がプランジャーに把持された状態で、プッシャーによって押されることによって穿刺部材に沿って前方に移動する
ことを特徴とするランセットアッセンブリ。 - ランセットボディは、保護カバーの後端部の前方に位置する突出部、および後方に位置する突出部を有して成り、
ランセットアッセンブリをインジェクターアッセンブリに装填するに際して、後方の突出部は、その位置が穿刺部材に向かうように変位し、それによって、ランセットボディの後方の突出部は保護カバーの後端部より前方に移動可能となる
ことを特徴とする請求項5に記載のランセットアッセンブリ。 - 保護カバーは後端部に開口部を有し、保護カバーがプッシャーによって押されて前方に移動すると、保護カバーの後端部の前方に位置する、ランセットボディの突出部が、保護カバーの後端部の開口部に嵌り込むように構成されている
ことを特徴とする請求項5に記載のランセットアッセンブリ。 - 請求項1~4のいずれかに記載の穿刺デバイスを構成するための請求項5~7のいずれかに記載のランセットアッセンブリ。
- インジェクターボディならびにその中に配置されたプランジャーおよびプッシャーを有して成り、前方部分が保護カバーによって包囲され、また、穿刺部材の先端部が突出した状態にあるランセットボディを発射するインジェクターアッセンブリであって、
(1)プランジャーは、ランセットボディの後端部を把持し、突出した穿刺部材の先端部が所定箇所を穿刺するようにランセットボディを発射し、
(2)プッシャーは、穿刺後、ランセットボディの後端部がプランジャーに握持された状態で、保護カバーをランセットボディに対して前方に押して穿刺部材に沿って前方に移動させ、
(3)インジェクターボディは、穿刺に際して、保護カバーの前端開口部がインジェクターボディの前端よりも前方に位置した状態となるように保護カバーを位置決めする保持部材を有する
ことを特徴とするインジェクターアッセンブリ。 - プッシャーがランセットボディの周囲に配置された保護カバーを前方に押すために、プッシャーをプランジャーに対して前方に移動させる時、プランジャーの前方への移動が阻止されるようになっている
ことを特徴とする請求項9に記載のインジェクターアッセンブリ。 - ランセットボディの突出部をその位置が穿刺部材に向かうように変位させる押し込み手段を更に有して成る
ことを特徴とする請求項9または10に記載のインジェクターアッセンブリ。 - プランジャーは、少なくとも2つのアームを有して成る前方部分を有して成り、
アームの前端部は、ランセットボディの後方部分を把持するチャック要素を構成する
ことを特徴とする請求項9~11のいずれかに記載のインジェクターアッセンブリ。 - プッシャーと連動するスライディングガイドを有し、
穿刺後、プッシャーが保護カバーをランセットボディに対して穿刺部材に沿って前方に移動させた後に、スライディングガイドは、プランジャーの少なくとも1つのアームが外側に広がることを許容する
ことを特徴とする請求項9~12のいずれかに記載のインジェクターアッセンブリ。 - 請求項1~4のいずれかに記載の穿刺デバイスを構成するための請求項9~13のいずれかに記載のインジェクターアッセンブリ。
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JP2012537778A JP5878872B2 (ja) | 2010-10-08 | 2011-10-07 | 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 |
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JP2015173809A (ja) * | 2014-03-14 | 2015-10-05 | パナソニックヘルスケアホールディングス株式会社 | 穿刺器具 |
US9649060B2 (en) | 2012-07-31 | 2017-05-16 | Panasonic Healthcare Holdings Co., Ltd. | Puncture needle cartridge and puncture device using same |
WO2019045580A1 (en) * | 2017-09-02 | 2019-03-07 | Htl-Strefa Spolka Akcyjna | DEVICE FOR PERFORATING THE SKIN OF A PATIENT |
JP2019217300A (ja) * | 2015-02-19 | 2019-12-26 | 泉株式会社 | インジェクター、ランセットアッセンブリおよび穿刺デバイス |
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JP6549185B2 (ja) * | 2017-06-16 | 2019-07-24 | 株式会社旭ポリスライダー | インジェクター |
CN112512817B (zh) * | 2018-08-30 | 2022-08-19 | 惠普发展公司,有限责任合伙企业 | 具有柱塞的注射器 |
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JP2008307423A (ja) * | 2001-07-11 | 2008-12-25 | Arkray Inc | ランセットおよび穿刺装置 |
JP2010172709A (ja) * | 2010-03-15 | 2010-08-12 | Panasonic Corp | 穿刺針カートリッジ |
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2011
- 2011-10-07 WO PCT/JP2011/073246 patent/WO2012046851A1/ja active Application Filing
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JP2008307423A (ja) * | 2001-07-11 | 2008-12-25 | Arkray Inc | ランセットおよび穿刺装置 |
WO2007018215A1 (ja) * | 2005-08-10 | 2007-02-15 | Izumi-Cosmo Company, Limited | 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 |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US9649060B2 (en) | 2012-07-31 | 2017-05-16 | Panasonic Healthcare Holdings Co., Ltd. | Puncture needle cartridge and puncture device using same |
JP2015173809A (ja) * | 2014-03-14 | 2015-10-05 | パナソニックヘルスケアホールディングス株式会社 | 穿刺器具 |
JP2019217300A (ja) * | 2015-02-19 | 2019-12-26 | 泉株式会社 | インジェクター、ランセットアッセンブリおよび穿刺デバイス |
WO2019045580A1 (en) * | 2017-09-02 | 2019-03-07 | Htl-Strefa Spolka Akcyjna | DEVICE FOR PERFORATING THE SKIN OF A PATIENT |
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CN103153187B (zh) | 2015-06-10 |
JP5878872B2 (ja) | 2016-03-08 |
CN103153187A (zh) | 2013-06-12 |
JPWO2012046851A1 (ja) | 2014-02-24 |
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