WO2014083783A1 - 穿刺器具、穿刺器具に装着する穿刺針カートリッジ、及び穿刺器具及び穿刺針カートリッジの使用方法 - Google Patents
穿刺器具、穿刺器具に装着する穿刺針カートリッジ、及び穿刺器具及び穿刺針カートリッジの使用方法 Download PDFInfo
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- WO2014083783A1 WO2014083783A1 PCT/JP2013/006630 JP2013006630W WO2014083783A1 WO 2014083783 A1 WO2014083783 A1 WO 2014083783A1 JP 2013006630 W JP2013006630 W JP 2013006630W WO 2014083783 A1 WO2014083783 A1 WO 2014083783A1
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- WIPO (PCT)
- Prior art keywords
- lancet
- puncture needle
- puncture
- end side
- needle cartridge
- 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
- A61B5/150007—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
- A61B5/150725—Procedure for removing protection means at the time of piercing removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1433—Devices for taking blood samples provided with locking means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
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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
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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
-
- 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
-
- 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
-
- 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
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
Definitions
- the present disclosure relates to a puncture device that punctures a human body and causes blood to flow out, for example, to measure blood glucose level, a puncture needle cartridge that is attached to and discarded from the puncture device, and a method of using the puncture device and the puncture needle cartridge. is there.
- the puncture device includes a cylindrical main body case having an opening, a lancet holder provided in the main body case, a biasing body that biases the lancet holder toward the front end opening of the main body case, and a lancet holder. It has the structure which has the lock nail
- the lock claw is released and the lancet holder moves to the front end opening side of the main body case by urging by the urging body.
- the second operation button is operated, the lancet is detached from the lancet holder.
- the puncture needle cartridge having the lancet is inserted into the opening of the puncture device and the lancet is attached to the lancet holder of the puncture device in the first mounting operation.
- the first operation button of the puncture device is operated in the next puncture operation, puncture by the lancet is performed. Thereafter, by operating the second operation button of the puncture device, the lancet is detached from the lancet holder, whereby the puncture cartridge is detached from the puncture device and discarded.
- the puncture needle cartridge is mounted on the puncture device as the first mounting operation, puncture is performed by the first operation button as the next puncture operation, and the puncture needle is performed by the second operation button as the subsequent disposal operation.
- the cartridge is to be discarded.
- the puncture device provided with the first and second operation buttons for performing the puncture operation and the discarding operation after the mounting operation is often mistaken for a person who is not yet used to handling the puncture device.
- all of the puncture devices that are currently in practical use have the first and second operation buttons.
- the puncture device is still configured to include two operation buttons, and the user often makes a mistake in the puncture operation and the disposal operation, which is inconvenient. Also in the mounting operation, the user must hold the puncture needle cartridge in one hand and hold the puncture device in the other hand, that is, use both hands to perform the mounting operation. Was bad. That is, the conventional puncture device is not easy to use when performing a series of puncture-related operations (attachment operation, puncture operation, disposal operation).
- the present disclosure provides a puncture device or a puncture needle cartridge that improves the operability of a series of puncture-related operations.
- the puncture device has the other end side facing the same end side as the one end side on which the puncture needle cartridge is mounted, and includes a main body case, a main rod, an injection rod, and an operating rod. , A first urging body, an operating rod, and a lock body.
- the main body case has openings on one end side and the other end side.
- the main rod is provided in the main body case.
- the injection rod is attached to the main rod and has a lancet holder on one end side.
- the operating rod is attached to the injection rod and has an engaging portion on the other end side.
- the first urging body urges the injection rod in one end side direction.
- the operating rod is slidably provided inside and outside the opening on the other end side of the main body case.
- the lock body is pivotally supported by the main rod portion between the operating rod and the injection rod.
- the lock body includes a first engaged portion that engages with the engaging portion of the operating rod, a second engaged portion that abuts against a portion on one end side of the operating rod, and a first engaged portion.
- a second urging body that urges toward the engaging portion.
- the puncture needle cartridge has one end side for projecting the puncture needle and the other end side facing the same end side, and the lancet body, the puncture needle, the puncture needle cover portion, and the connection portion , A lancet case, a guide protrusion, a spiral guide, a sliding protrusion, and a sliding groove.
- the lancet body has a fracture portion at an intermediate portion.
- the puncture needle is embedded in the lancet body over the front and rear of the rupture portion of the lancet body.
- the puncture needle cover part is provided on one end side of the lancet body.
- a connection part is a connection part to the puncture device provided in the other end side of the lancet main body.
- the lancet case is attached to the outer periphery of the lancet body.
- the guide protrusion protrudes on the puncture needle cover part.
- the guide portion is formed from one end side to the other end side of the lancet case, and guides the guide protrusion so that the lancet case receives a turning force.
- the sliding protrusion is formed closer to the other end side than the fracture portion of the lancet body and protrudes outward.
- the sliding groove is formed in the lancet case and guides the sliding protrusion.
- the puncture device or puncture needle cartridge according to the present disclosure is effective for enhancing the operability of a series of puncture-related operations.
- FIG. 1 is a perspective view of a puncture device according to Embodiment 1.
- FIG. Perspective view of a puncture needle cartridge to be mounted on the puncture device The figure which shows the use condition of the puncture device.
- the figure which shows the use condition of the puncture device The figure which shows the use condition of the puncture device
- Exploded perspective view of the puncture needle cartridge A) Top view of the puncture needle cartridge, (b) Front view of the puncture needle cartridge Development of the main part of the puncture needle cartridge (A) AA sectional view of FIG. 7, (b) AA sectional view of FIG. 7 during the same operation, (c) AA sectional view of FIG.
- FIG. 1 shows a puncture device 1 of the present embodiment.
- the puncture device 1 is a device that punctures a human body and causes blood to flow out, for example, in order to measure a blood glucose level.
- the puncture device 1 performs puncture by attaching the puncture needle cartridge 4 of FIG. 2 to the front end opening 3 of the long cylindrical main body case 2.
- the operation related to the puncture includes three operations, that is, a puncture needle cartridge 4 mounting operation, a puncture operation, and a puncture needle cartridge 4 disposal operation.
- the puncture needle in which the user holds the puncture device 1 with, for example, the right hand and makes the front end opening 3 of the puncture device 1 upright. Push down toward the cartridge 4. Then, the puncture needle cartridge 4 is attached to the puncture device 1.
- the puncturing operation that is the second operation, as shown in FIG. 4, the user presses the puncture needle cartridge 4 against, for example, the finger of the left hand and the thumb of the right hand holding the puncture device 1, Press the operation button 5.
- puncture is performed, and blood flows out to the punctured site of the finger of the left hand.
- the puncture needle cartridge 4 is detached from the puncture device 1, and the puncture needle cartridge 4 is discarded. Is done.
- a series of puncturing-related operations (a mounting operation, a puncturing operation, and a discarding operation) can be performed only by operating one button while holding the puncture device 1 with one hand. .
- the puncture device 1 is extremely easy to use, and as a result, the operability of a series of puncture-related operations can be improved.
- the puncture needle cartridge 4 includes a substantially cylindrical lancet body 6 and a substantially cylindrical lancet case 7.
- the substantially cylindrical lancet body 6 is made of resin, and has a connecting portion 8 to the puncture device 1 on the rear end side, a cylindrical puncture needle cover portion 9 on the front end side, and a breaking portion 10 on the intermediate portion.
- a puncture needle 11 (also shown in FIGS. 17 to 21) is embedded in the lancet body 6 across the rupture portion 10 of the lancet body 6.
- two (a plurality) guide protrusions 12 protruding in the outer peripheral direction are provided at positions opposed to each other by 180 degrees.
- a cylindrical resin lancet case 7 is placed on the columnar lancet body 6 from the side of the connecting portion 8 provided at the rear end of the lancet body 6, and is shown in FIGS. 7 (a) and 7 (b). As shown, it is attached to the outer periphery of the intermediate part of the lancet body 6. As shown in FIG. 6, a spiral guide portion 13 is formed on the inner surface of the cylindrical lancet case 7 from the front end to the rear. When the lancet case 7 is attached to the lancet body 6, two guide portions 13 are provided at positions corresponding to the two guide protrusions 12 of the lancet body 6, that is, at positions opposite to the guide protrusions 12 by 180 degrees. ) Is formed. Since the guide part 13 is formed in a spiral shape, the lancet case 7 receives a turning force by the guide protrusion 12 when the guide protrusion 12 of the lancet body 6 is inserted and guided in the guide part 13.
- FIG. 8 is a development view of the inner surface side of the lancet case 7 and shows a spiral guide portion 13 portion.
- the guide portion 13 extends from the front end of the lancet case 7 toward the rear at an interval of 180 degrees on the inner surface of the cylindrical lancet case 7. For this reason, when the lancet case 7 is slid in the forward direction (the direction of arrow C in FIGS. 7 and 8), the spiral guide portion 13 slides on the guide projection 12 in the direction of the arrow D. A turning force can be generated around the lancet body 6.
- two (a plurality) of sliding protrusions 14 projecting toward the outer peripheral direction are provided on the rear side of the fracture portion 10 of the lancet body 6 so as to face each other by 180 degrees.
- the lancet case 7 is provided with two (a plurality) of sliding grooves 15 that slide the sliding protrusions 14 in the front-rear direction so as to face each other by 180 degrees. For this reason, when the lancet case 7 slides in the forward direction, the two sliding protrusions 14 slide backward in the respective sliding grooves 15.
- annular concave portion 7 a that opens toward the connection portion 8 side is provided on the outer peripheral portion on the front end side of the lancet case 7.
- An annular contact surface 7b is provided at the bottom of the recess 7a.
- the contact surface 7 b is substantially orthogonal to the axial direction of the lancet case 7.
- the spiral guide portion 13 slides on the guide projection 12, so that the lancet case 7 is rotated clockwise ( A turning force in the direction of arrow B is generated. That is, the lancet case 7 rotates in the clockwise direction around the lancet body 6 by sliding in the forward direction.
- FIG. 9B shows a state where the lancet case 7 is rotated 90 degrees clockwise from the state shown in FIG. 9A
- FIG. 9C shows a state where the lancet case 7 is rotated 180 degrees.
- the lancet case 7 that rotates in the clockwise direction rotates the sliding protrusion 14 of the lancet body 6 that contacts the sliding wall surface 15a of the sliding groove 15 shown in FIG. 9B in the clockwise direction.
- the sliding protrusion 14 rotates in the clockwise direction on the rear side (the upper side in FIGS. 9A to 9C) of the rupture portion 10 of the lancet body 6.
- the lancet case 7 that slides in the forward direction has its spiral guide portion 13 that pushes the guide protrusion 12 of the lancet body 6 so that the lancet body 6
- the front side of the broken portion 10 (the lower side of FIGS. 9A to 9C) rotates counterclockwise (the direction opposite to the rotation direction of the guide portion 13 and the direction opposite to the arrow B direction). To do. Therefore, when the lancet case 7 slides in the forward direction, the fractured portion 10 in which the puncture needle 11 is embedded receives the rotational force in the reverse direction by the front and rear connecting portions, and threading starts from the state of FIG. Then, it breaks in a state where it shifts from FIG. 9 (b) to (c).
- the puncture needle cartridge 4 of the present embodiment rotates clockwise behind the breaking portion 10 of the lancet body 6 in the puncture needle cartridge 4 in accordance with the operation of mounting the puncture needle cartridge 4 on the puncture device 1.
- the puncture needle cartridge 4 itself has a turning mechanism for breaking the breaking portion 10 by turning in the two opposite directions.
- the front end opening 3 of the puncture device 1 held with one hand can be attached to the puncture device 1 at the connection portion 8 simply by pushing down the front end opening 3 toward the puncture needle cartridge 4 that is upright.
- a force in the reverse direction can be generated at the connecting portions before and after the broken portion 10, so that the broken portion 10 can be reliably broken.
- the puncture needle cover portion 9 can be easily removed from the puncture needle cartridge 4, and the puncture needle 11 can be exposed to the lancet body 6. As a result, the subsequent puncturing operation can be appropriately performed. Further, as described above, during the mounting operation, the puncture needle cartridge 4 itself rotates the front and rear portions of the breaking portion 10 in the reverse direction. There is no need to keep it fixed. As a result, it is easy to use.
- the lancet body 6 has a disk-shaped base 16 at its front end as shown in FIG.
- the base portion 16 is provided with two leaf springs 17 (an example of an elastic body) at a portion facing the front end of the lancet case 7 with a cylindrical puncture needle cover portion 9 interposed therebetween.
- Two leaf springs 17 are provided integrally with the base portion 16.
- the two leaf springs 17 of the base portion 16 are connected to the front end of the lancet case 7 with the broken portion 10 being completely threaded.
- the leaf spring 17 pushes up the base portion 16 rearward (upward direction in FIGS. 9A to 9C). With this push-up, the user can be informed of the end of the mounting operation of the puncture needle cartridge 4, and the user can be guided to the next operation, that is, the lifting operation of the pushed-down puncture device 1. Become.
- the puncture needle cover portion 9 is already threaded as shown in FIG. It is removed so that it can play from the part 10 part. Then, the puncture needle 11 is exposed at the front end portion of the lancet body 6. Thus, since the puncture needle cover 9 can be automatically removed, the puncture needle cartridge 4 is also easy to use from this point.
- the base portion 16 of the present embodiment is configured to be larger than the puncture needle cover portion 9 (that is, the base portion 16 is larger than the puncture needle cover portion 16 in the direction crossing the axis of the lancet body 6). (Having a large cross-sectional area), the puncture needle cartridge 4 can be stably erected and the mounting operation is facilitated.
- FIG. 10 is an exploded view of the cylindrical puncture device 1 in the axial direction.
- the main body case 2 of the puncture device 1 according to the present embodiment is a substantially cylindrical body having a front end opening 3 and a rear end opening 18, and includes a case piece 2a and a case piece 2b.
- the components housed in the main body case 2 will be described with reference to FIG.
- the largest component among the components housed in the main body case 2 is a main rod 19 having a holder insertion cylinder 20 (an example of a holder insertion cylinder portion) on the front end side.
- An injection rod 21 having a lancet holder 22 is attached to the front side (left side in FIG. 11) of the main rod 19.
- the injection rod 21 has a cylindrical lancet holder 22 on the front end side for mounting the lancet body 6 of the puncture needle cartridge 4 of FIG.
- the injection rod 21 is provided with a long plate-shaped operating rod 23 on the case piece 2a side.
- the operating rod 23 has a lock claw 24 (an example of an engaging portion) on the rear end side.
- FIG. 12 is a view of the state where the operating rod 23 is attached to the injection rod 21 as viewed from the case piece 2a side.
- the injection rod 21 of the present embodiment is mounted with a working rod 23 slidably in the front-rear direction of the main body case 2. Further, the operating rod 23 is biased in the direction of the lock body 28 in FIG. 10 by an operating spring 27 (an example of a third biasing body).
- two long holes 25 that are long in the front-rear direction are provided on the front end side and the rear end side of the operating rod 23, and the long holes 25 are engaged with the two shaft portions 26 of the injection rod 21.
- the operating rod 23 is slidable in the front-rear direction of the main body case 2. Further, the front end portion of the operating rod 23 and the rear end portion of the injection rod 21 are connected by the operating spring 27, and the operating rod 23 is urged rearward, that is, urged toward the lock body 28 in FIG. .
- the injection rod 21 has the axial support part 31 of the puncture cam 30 fitted in the axial part 29 of the rear end side by the case piece 2b side.
- the injection rod 21 is slidable in the front-rear direction of the main body case 2 by the main rod 19. Retained.
- a part of the holder insertion cylinder 20 is notched and displayed so that the state of the tip side of the lancet holder 22 inserted into the holder insertion cylinder 20 can be clearly understood.
- the main rod 19 is provided with a main spring 34 (an example of a first biasing body) that biases the injection rod 21 toward the front side (front end opening 3 side) of the main body case 2. More specifically, a shaft portion 32 is provided on the puncture cam 30 on the injection rod 21, the shaft portion 32 and the shaft portion 33 on the front end side of the main rod 19 are connected by a main spring 34, and the injection rod 21 is moved forward. Energize. For this reason, the injection rod 21 slides toward the front end opening 3 by the urging force of the main spring 34, whereby a puncturing operation is performed.
- a main spring 34 an example of a first biasing body
- the main body case 2 further includes an operation button 5 (an example of an operation rod) slidably provided inside and outside the rear end opening 18 of the main body case 2.
- the operation button 5 has an operation body 35 at the front end, and includes a button spring 36 in the cylindrical portion on the rear end side.
- the operation body 35 is provided with a flat surface portion 50 that abuts on the push-out claw 40 (an example of the second engaged portion) of the lock body 28 at the center portion on the front end side.
- the flat surface portion 50 is provided with an upper inclined surface portion 51 and a lower inclined surface portion 52 which are adjacent and extend rearward.
- the upper inclined surface portion 51 and the lower inclined surface portion 52 are provided to be inclined with respect to the axis of the main body case 1. For this reason, when the operation button 5 is operated, the lock body 28 on the front side can be operated by the operation body 35.
- the lock body 28 is one of the characteristic parts of the present embodiment, and the lock body 28 is switched between the “puncture operation” and the “discard operation” by operating the operation button 5. Specifically, the lock body 28 is pivotally supported by a shaft portion 37 provided on the rear side of the main rod 19 between the operation button 5 and the injection rod 21. Further, the lock body 28 has a fan shape as shown in FIGS. 10, 11, and 13 to 21, and has a shaft support portion 38 at a main portion thereof. The shaft support portion 38 is provided on the operation button 5 on the fan portion side. In the state facing toward, the shaft portion 37 of the main rod 19 is fitted. Further, as shown in FIGS.
- the lock body 28 is engaged with the lock claw 24 of the operating rod 23 on the operating rod 23 side (hereinafter also referred to as the fan lower side) on the fan-shaped tip side. It has a joint claw 39 (an example of a first engaged portion) and abuts against the front end side of the operation button 5 on the fan-shaped tip side opposite to the operating rod 23 (hereinafter also referred to as fan upper side). It has an extrusion claw 40.
- a lock that biases the engaging claw 39 of the lock body 28 toward the lock claw 24 of the actuating rod 23 (clockwise direction in FIG. 10, hereinafter referred to as clockwise direction) is provided on the shaft support portion 38 of the lock body 28.
- a body spring 41 (an example of a second urging body) is formed by a coil spring and attached.
- the engagement claw 39 of the lock body 28 is engaged with the lock claw 24, and the forward sliding (injection) of the injection rod 21 is locked.
- the puncturing operation and the discarding operation are switched by rotating the lock body 28. This switching operation will be described in detail later.
- a cylindrical bush 42 is attached to the front end side of the main body case 2 so as to be rotatable about the axis of the main body case 2. Specifically, a rotating ring 43 provided on the rear side of the bush 42 is inserted into the groove 44 of the main body case 2 and is rotatably mounted on the main body case 2. The holder insertion cylinder 20 of the main rod 19 is inserted into the bush 42. In this state, the case piece 2a and the case piece 2b are matched.
- FIG. 13 is a diagram illustrating an initial state of the main body case 2.
- the initial state is a state before the user holds down the puncture device 1 and pushes down the puncture device 1 toward the puncture needle cartridge 4 upright as shown in FIG.
- the main rod 19 is moved forward by the button spring 36 included in the operation button 5 in the main body case 2. Pushed to the side. As a result, the main rod 19 stops at a position where the case stopper contact 45 of the injection rod 21 attached to the main rod 19 contacts the front case stopper 46 of the main body case 2.
- the main spring 34 pulls the puncture cam 30 of the injection rod 21 forward.
- the puncture cam 30 rotates counterclockwise (in the counterclockwise direction in FIG. 13 and hereinafter referred to as the counterclockwise direction in FIG. 13) about the shaft support portion 31, and the stop pawl 47 is moved to the rib 48 of the injection rod 21. It stops by contacting.
- the main spring 34 pulls the injection rod 21 forward through the puncture cam 30.
- the injection rod 21 stops with respect to the main rod 19 at a position where the puncture cam 30 contacts the puncture cam stopper 49 of the main rod 19.
- the main rod 19 of the present embodiment has a lock piece lower stopper 53 (an example of a first stopper portion).
- the lock piece lower stopper 53 is operated by the push-out pawl 40 of the lock body 28 when the lock body 28 pivotally supported on the rear side of the main rod 19 is rotated clockwise (the urging direction of the lock body spring 41). The rotation is stopped at a position facing the flat portion 50 of the button 5. For this reason, the lock body 28 rotated clockwise by the lock body spring 41 stops by pushing the pushing claw 40 on the fan upper side against the lock piece lower stopper 53.
- FIG. 14 is a view showing a state in which the puncture needle cartridge 4 is pushed into the main body case 2.
- the state of the puncture needle cartridge 4 in FIG. 14 corresponds to that in FIG.
- the puncture needle cartridge 4 is pushed into the main body case 2
- the lancet main body 6 is engaged with the lancet holder 22 of the injection rod 21 at the connecting portion 8.
- the puncture needle cartridge 4 is attached to the puncture device 1.
- the puncture needle cartridge 4 is further pushed into the main body case 2
- the lancet main body 6 pushes the injection rod 21 rearward.
- the injection rod 21 pushes the main rod 19 backward via the puncture cam 30 and the main spring 34, the rear end portion 54 of the main rod 19 becomes the main rod stopper 55 (FIG.
- FIG. 15 is a view showing a state in which the lancet case 7 is turned 90 degrees with respect to the lancet body 6 (state shown in FIG. 9B).
- the broken portion 10 is in a state just before the thread cutting.
- the injection rod 21 further moves rearward, and the lock claw 24 on the rear side of the operating rod 23 abuts on the engagement claw 39 of the lock body 28.
- the actuating rod 23 of the present embodiment rotates the engagement claw 39 of the lock body 28 in the direction opposite to the urging direction by the lock body spring 41 with the lock claw 24 on the rear end side.
- the engagement claw 39 is attached by the lock body spring 41 by the surface of the actuating rod 23 facing the engagement claw 39 of the lock body 28, that is, the rotation prevention portion 23 a (an example of the rotation prevention portion). It is prevented from rotating in the urging direction. For this reason, when the injection rod 21 moves backward from the state shown in FIG. 15, the lock claw 24 pushes up the engagement claw 39 below the fan of the lock body 28, and the engagement claw 39 rotates counterclockwise. . After that, as shown in FIG. 16, when the lock claw 24 pushes over the engagement claw 39, the engagement claw 39 tries to rotate in the clockwise direction, but comes into contact with the rotation preventing portion 23a of the operating rod 23 and rotates. Stop moving.
- FIG. 16 is a view showing a state where the lancet case 7 is turned 180 degrees with respect to the lancet body 6 (the state shown in FIG. 9C).
- the injection rod 21 slides backward in the stopped main rod 19 and stops when the case stopper contact 45 abuts the rear case stopper 56 of the main body case 2.
- the main spring 34 is extended to the maximum, and the puncture force is in a state of being fed.
- FIG. 17 is a diagram illustrating the completion of the mounting operation of the puncture needle cartridge 4.
- FIG. 18 is a diagram showing a puncturing operation.
- the operating rod 23 of the present embodiment is configured such that when the lock claw 24 of the operating rod 23 is engaged with the engaging claw 39 on the lower side of the fan of the lock body 28, The push-out claw 40 on the upper side is disposed at a position facing the upper inclined surface portion 51 of the operation button 5.
- the puncture needle 11 of the lancet body 6 engaged with the ejection rod 21 is ejected from the front end of the puncture needle cartridge 4. As a result, the puncture needle 11 is punctured with respect to the user's finger or the like.
- the center of the puncture cam 30 abuts against the puncture cam stopper 49 and rotates clockwise to extend the main spring 34.
- the main spring 34 re-contracts.
- the injection rod 21 is pulled toward the rear end opening 18 as shown in FIG. 19 after puncturing, and the puncture needle 11 is moved into the lancet case 7. It is pulled back.
- the main body case 2 of the present embodiment is provided with a lock piece upper stopper 58 (an example of a second stopper portion).
- the lock piece upper stopper 58 is formed when the push-out pawl 40 of the lock body 28 is rotated counterclockwise by the upper inclined surface portion 51 of the operation button 5 (that is, the direction opposite to the urging force of the lock body spring 41). Stop rotation in the opposite direction. For this reason, when the user further pushes the operation button 5, the push-out claw 40 rotates and comes into contact with the lock piece upper stopper 58. In this contact state, the operation button 5 cannot be pushed, so that the user can recognize the end of the puncture. As a result, the user stops pushing the operation button 5, releases his finger from the operation button 5, and ends the puncture operation.
- the puncture device 1 has a main body case 2 having a long cylindrical shape, and an operation button 5 that can slide freely inside and outside the rear end opening 18 of the main body case 2 is placed on the axis of the main body case 2.
- the operation button 5 is slid on the shaft of the main body case 2 to thereby perform a puncturing operation. Therefore, as shown in FIG. 4, during the puncture operation, the user holds the puncture needle cartridge 4 against the finger and stabilizes the long cylindrical body case 2 by grasping it with the palm.
- the operation button 5 can be pushed toward the puncture position on the axis of the main body case 2.
- the puncture needle cartridge 4 and the puncture device 1 in the present embodiment can perform puncture in an extremely stable state, and are easy to use.
- FIG. 19 is a diagram illustrating a completion state of the puncturing operation and a diagram illustrating a start of the discarding operation.
- the pushing pawl 40 of the lock body 28 stops rotating at a position facing the flat portion 50 of the operation button 5 by the lock piece lower stopper 53. Therefore, when the operation button 5 is pushed again, the operation body 35 can operate the lock body 28 via the push-out claw 40 at the flat surface portion 50 as described later.
- FIG. 20 is a diagram showing a discarding operation of the puncture needle cartridge 4.
- the shaft support portion 38 to the main rod 19 is positioned at a portion corresponding to the upper inclined surface portion 51 inclined from the flat portion 50 of the operation button 5. For this reason, when the operation button 5 is pressed, the flat portion 50 of the operation body 35 comes into contact with the push-out claw 40 of the lock body 28. At this time, since the shaft support portion 38 is located on the upper inclined surface portion 51 side with respect to the contact portion between the flat portion 50 and the push-out claw 40, the push-out claw 40 tends to rotate clockwise. However, the push-out claw 40 is in contact with the lock piece lower stopper 53 and stopped from rotating.
- the main rod 19 can be slid forward together with the lock body 28 via the push-out pawl 40 and the shaft portion 37 of the lock body 28.
- the injection rod 21 is also pulled by the main spring 34 and slides forward together with the main rod 19.
- the main rod 19 of the present embodiment is provided with a holder insertion cylinder 20 that houses the lancet holder 22 of the injection rod 21 on the front end side thereof.
- a lancet pushing surface 59 (an example of a pushing surface) is provided at the front end of the holder insertion cylinder 20. Therefore, when the main rod 19 slides forward, the lancet pushing surface 59 comes into contact with the rear end of the lancet case 7 and the puncture needle cartridge 4 can be pushed out of the main body case 2.
- the case stopper 45 of the injection rod 21 comes into contact with the front case stopper 46.
- the main rod 19 stops sliding with respect to the main body case 2 and the operation rod 23 attached to the injection rod 21 also stops.
- the lock body 28 of this embodiment is provided with a pressing surface 60 (an example of a pressing surface) that pushes the locking claw 24 of the operating rod 23 toward the front side of the main body case 2 on the front side of the engaging claw 39 on the fan lower side.
- the injection rod 21 of the present embodiment is mounted with the operating rod 23 slidably in the front-rear direction of the main body case 2.
- the operating rod 23 is urged toward the lock body 28 by an operating spring 27. For this reason, as shown in FIG. 21, even when the injection rod 21 is stopped, the pressing surface 60 can push the lock claw 24 and slide the operating rod 23 forward. As a result, the main rod 19 and the lock body 28 can continue to slide forward.
- FIG. 21 is a diagram showing a completed state of the discarding operation.
- the lancet pushing surface 59 pushes the lancet case 7 forward on the front side of the main body case 2.
- the lancet case 7 pulls the lancet body 6 forward through the sliding protrusion 14 and is pulled out from the lancet holder 22 of the injection rod 21 in which the connecting portion 8 of the lancet body 6 is stopped.
- the lancet pushing surface 59 completely pushes the lancet case 7 out of the main body case 2, the disposal operation is completed.
- the discarding operation of the puncture needle cartridge 4 can be performed simply by pressing the operation button 5. Thereafter, when the user removes his / her finger from the operation button 5, the main rod 19 is pulled back by the restoring force of the main spring 34, and the initial state shown in FIG. 13 is restored. That is, as shown in FIG. 17, the lock body 28 according to the present embodiment has the push-out claw 40 disposed at a position facing the upper inclined surface portion 51 of the operation body 35 as shown in FIG. As shown in FIG. 4, the push-out claw 40 is disposed at a position facing the flat portion 50 of the operation button 5. For this reason, the lock body 28 can switch the operation of the operation button 5 to two operations, that is, a puncture operation and a discard operation.
- the user can hold the puncture needle cartridge 4 without changing the grip. Puncturing operation and discarding operation can be performed. Moreover, the puncturing operation and the discarding operation can be performed with one operation button 5. As a result, since a series of puncturing operations can be performed by one-hand operation, the puncture device 1 is extremely easy to use, and the operability of a series of puncture-related operations can be improved.
- the sliding protrusion 14 is elastically deformed and almost entirely enters the sliding groove 15 before the puncturing operation, as shown in FIG.
- the tip of the sliding projection 14 is once pulled out from the sliding groove to the front side, and is again pulled back to the sliding projection as shown in FIG. 14 is almost in the state of being in the sliding groove 15.
- the sliding protrusion 14 spreads the tip side to the outside of the sliding groove 15 and slides in the sliding groove 15.
- the lancet case 7 of the present embodiment is slid at a position on the front-side inner peripheral portion, behind the tip of the lancet case 7 and behind the tip of the puncture needle 11. It has a bearing 61 (an example of a sliding receiver).
- the slide receiver 61 abuts the tip of the sliding protrusion 14 of the lancet body 6. For this reason, after the puncture needle cartridge 4 is discharged, the puncture needle 11 stops at the position where the tip of the sliding projection 14 and the slide receiver 61 abut, and the puncture needle 11 does not protrude from the puncture needle cartridge 4. Absent.
- the operation button 5 may be pushed in during the mounting operation. Specifically, as shown in FIG. 14, when the lancet body 6 on the front side of the body case 2 is engaged with the injection rod 21 via the lancet holder 22, the operation button 5 on the rear side is pushed. There is a case. At this time, since the operation button 5 slides the lock body 28 forward through the flat portion 50 and the push-out claw 40, the engagement claw 39 of the lock body 28 hits the lock claw 24 on the front side. The lock claw 24 is pushed toward the injection rod 21. That is, the injection rod 21 receives the force of the lancet body 6 from the front and the force of the operation button 5 from the rear.
- the injection rod 21 of the present embodiment is mounted with the operating rod 23 slidably in the front-rear direction of the main body case 2. Therefore, when the operation button 5 is further pushed, the pressing surface 60 of the engaging claw 39 pushes the operating rod 23 forward through the lock claw 24, and the operating rod 23 is slid forward on the injection rod 21. Move. That is, the injection rod 21 can absorb the force from the front-rear direction by sliding the operating rod 23. Accordingly, the injection rod 21 itself does not receive a large force, and an inappropriate state such as breakage is not generated.
- the injection rod 21 does not receive a large force, it is possible to reduce the thickness and weight while maintaining a sufficient strength. Since this light injection rod 21 can be punctured with a small output, the biasing force of the main spring 34 toward the front side can be small. Therefore, during the puncturing operation, it is possible to reduce a large collision sound that is generated when the puncture cam 30 pulled by the main spring 34 collides with the rib 48. As a result, the user's fear of puncturing is alleviated, and the puncture device 1 is also easy to use in this respect.
- the puncture needle cartridge 4 of the present embodiment includes the lancet body 6 having the connection portion 8 to the puncture device 1 on the rear end side, the puncture needle cover portion 9 on the front end side, and the breaking portion 10 on the intermediate portion.
- a puncture needle 11 embedded in the lancet body 6 and a lancet case 7 attached to the outer periphery of the intermediate portion of the lancet body 6 are provided before and after the fracture portion 10 of the lancet body 6.
- the puncture needle cover portion 9 of the lancet body 6 has a guide protrusion 12 that protrudes toward the outer periphery.
- the lancet case 7 is provided with a spiral guide portion 13 from the front end toward the rear so that the lancet case 7 receives a turning force by the guide protrusion 12.
- a sliding projection 14 On the rear side of the rupture portion 10 of the lancet body 6, there is provided a sliding projection 14 that protrudes toward the outer peripheral direction.
- the lancet case 7 is provided with a sliding groove 15 that slides and guides the sliding protrusion 14 in the front-rear direction.
- the puncture needle cartridge 4 can improve the operability during the mounting operation to the puncture device 1. That is, the puncture needle cartridge 4 of the present embodiment is rotated rearward of the rupture portion 10 of the lancet body 6 in the puncture needle cartridge 4 in accordance with the operation of mounting the puncture device 1, thereby causing the rupture portion 10.
- the puncture needle cartridge 4 itself has a rotation mechanism for breaking the puncture needle. For this reason, the puncture needle cartridge 4 is attached to the puncture device 1 by simply pushing down the front end opening 3 of the puncture device 1 held by the user with one hand toward the upright puncture needle cartridge 4, and The rupture portion 10 is broken and the puncture needle 11 is exposed. As a result, the fracture portion 10 can be reliably fractured so that the subsequent puncturing operation can be performed appropriately.
- the lock body 28 is pivotally supported by the main rod 19 portion between the operation button 5 and the ejection rod 21.
- the lock body 28 includes an engagement claw 39 that engages with the lock claw 24 of the operating rod 23 and a push-out claw 40 that abuts on the front end side of the operation button 5, and locks the engagement claw 39 of the lock body 28.
- a lock body spring 41 that biases the claw 24 in the direction is provided.
- the lock body 28 is rotated by the operation of the operation button 5.
- a puncturing operation is performed.
- the operation body 5 is operated, the lock body 28 is pushed to the front end opening 3 side via the push-out claw 40, and the pushed lock body 28 pushes the main rod 19 to the front end side via the shaft support portion.
- the disposal operation of the puncture needle cartridge 4 is performed. That is, in the puncture device 1 according to the present embodiment, the operation of the single operation button 5 is switched between the two operations of the lock body 28 of “puncture operation” of the puncture device 1 and “discard operation” of the puncture needle cartridge 4. I can do it. As a result, the puncture device 1 is extremely easy to use, and as a result, the operability of a series of puncture-related operations can be improved.
- the lock body 28 is rotated by the operation of the operation button 5.
- the puncturing operation is performed. Is implemented.
- the lock body 28 is pushed toward the front end opening through the push-out claw 40, and when the pushed lock body 28 pushes the main rod 19 through the shaft support 38, the puncture needle A cartridge discarding operation is performed. Therefore, since the puncture operation and the discard operation can be performed with only one button while holding the puncture device 1 with one hand, a person who is not yet used to handling the puncture device 1 is less likely to make a mistake.
- the puncture needle cartridge 4 of the present embodiment rotates in one direction in the puncture needle cartridge 4 with respect to the breaking portion 10 of the lancet body 6 in accordance with the operation of mounting the puncture needle cartridge 4 on the puncture device 1. And a turning mechanism for turning the front side in the other direction and breaking the breaking portion 10 by turning in the two opposite directions. For this reason, the puncture needle cartridge 4 is attached to the puncture device 1 simply by pushing down the front end opening of the puncture device 1 held with one hand toward the upright puncture needle cartridge 4, and the broken portion 10 thereof. Is broken and the puncture needle 11 is exposed, and preparation for puncture can be completed.
- the wearing operation can be performed while holding the puncture device 1 with one hand, so that a person who is not yet used to handling the puncture device 1 is less likely to make a mistake in the operation, and is very easy to use.
- the operability of the operation can be improved.
- a series of puncture-related operations attachment operation, puncture operation, disposal
- attachment operation puncture operation, disposal
- it is very easy to use and the operability of a series of puncture-related operations can be improved.
- FIGS. 2 A puncture needle cartridge 4 ′ according to the second embodiment will be described with reference to FIGS.
- the puncture needle cartridge 4 ′ according to the second embodiment is different from the first embodiment in the form of the sliding protrusion 14 ′ provided on the lancet body 6 ′.
- the other components similar to those in the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
- the tip of the sliding protrusion 14 provided on the lancet body 6 is arranged.
- a slide receiver 61 is provided for contact.
- the lancet body 6 may be pushed forward by the user with full force.
- the sliding protrusion 14 is not able to resist the user's force and is spread outward, then bends backward, so that the lancet body 6 advances forward and the puncture needle 11 is punctured.
- the sliding protrusion 14 ′ of the lancet body 6 ′ according to the second embodiment has a hook shape extending along the axis of the lancet body 6 and protrudes outward from the lancet body 6 ′.
- a projecting portion 62 (an example of the projecting portion), a connecting portion 63 (an example of the connecting portion) formed continuously to the projecting portion 62, and extending from the connecting portion 63 to the front side (the breaking portion 10 side).
- An abutment portion 64 (an example of an abutment portion) that abuts against the slide receiver 61 of the lancet case 7 is provided.
- the contact portion 64 is connected to the connection portion 63 so as to be rotatable along the axial direction of the lancet body 6 ′ with the connection portion 63 as a center. That is, since the connecting portion 63 is thin and flexible, the contact portion 64 is rotatable along the axial direction of the lancet body 6 ′.
- the thickness D3a in the direction perpendicular to the axis of the lancet body 6 'at the contact portion 64 is configured to have the following relationship.
- the hook-shaped sliding protrusion 14 ′ in the present embodiment is formed so that the bending strength of the connecting portion 63 portion is weaker than the protruding portion 62 portion and the abutting portion 64 portion.
- the thickness D4 of the connecting portion 63 portion in the direction perpendicular to the long axis of the sliding projection 14 ′ is the length of the sliding projection 14 ′ of the contact portion 64 portion.
- the thickness D3 in the direction perpendicular to the axis and the thickness 62 of the projecting portion 62 in the major axis direction of the sliding projection 14 ' were made thinner.
- the bending strength of the connecting portion 63 portion is made weaker than the protruding portion 62 portion and the contact portion 64 portion. For this reason, the sliding protrusion 14 'can bend the abutting portion 64 outward and rearward at the weakest connecting portion 63 portion, so that the abutting portion 64 and the protruding portion as shown in FIG. 62 can be folded. Therefore, the puncture needle 11 does not come out of the puncture needle cartridge 4 ′.
- the sliding protrusion 14 ′ of the present embodiment is bent substantially parallel to the lancet body 6 ′ from the connecting portion 63 toward the breaking portion 10, and the front side from the middle portion is lancet body 6.
- An abutting portion 64 is formed so as to extend outwardly from ′.
- the tip of the portion that spreads outward from the lancet body 6 'from the middle to the front side of the abutting portion 64 Abuts against the lancet body 6 'to form a bridge. Therefore, the contact part 64 and the protrusion part 62 can be appropriately folded, and the puncture needle 11 does not come out of the puncture needle cartridge 4 '.
- the contact portion 64 of the sliding projection 14 ′ provided on the lancet body 6 ′ is brought into contact with the sliding receiver 61 of the lancet case 7.
- the guide protrusion 12 of the lancet body 6 ′ is brought into contact with the spiral guide portion 13 of the lancet case 7.
- the spiral guide part 13 slides reliably on the guide protrusion 12.
- the puncture needle cartridge 4 ' has the following manufacturing process at the time of manufacture and is manufactured.
- the lancet case 7 is put on the outer periphery of the lancet body 6 'and pushed down, and the spiral guide portion 13 of the lancet case 7 is brought into contact with the guide protrusion 12 of the lancet body 6'. From this state, the lancet case 7 is pushed down while being rotated, whereby torsion is started at the fracture portion 10. Thereafter, for example, at a position where the lancet case 7 is rotated by 30 degrees, as shown in FIG. 25 (a), the slide receiver 61 of the lancet case 7 is lowered to the lower side of the slide projection 14 ′ of the lancet body 6 ′.
- the lancet case 7 is released at this position. Then, the restoring force due to the torsion of the broken portion 10 attempts to push up the lancet case 7 in the reverse direction, but the sliding protrusion 14 ′ causes the abutment portion 64 to abut against the slide receiver 61 and the lancet case 7. 7 is stopped. For this reason, the lancet case 7 can be stopped at a position where the spiral guide portion 13 properly rides on the guide protrusion 12 due to the elasticity of the sliding protrusion 14 ′. As a result, when the puncture needle cartridge 4 ′ is handled, the guide portion 13 is not detached from the guide protrusion 12, and the spiral guide portion 13 is moved over the guide protrusion 12 in the subsequent mounting operation. It can be made to slide properly. As described above, the puncture needle cartridge 4 ′ according to the second embodiment can be made easier to handle especially during the disposal operation by adding a device to the puncture needle cartridge 4 of the first embodiment.
- FIG. 26 A puncture needle cartridge 4 ′′ according to the third embodiment is shown in FIG. 26.
- This puncture needle cartridge 4 ′′ has a substantially rectangular shape instead of the base portion 16 in the puncture needle cartridge 4 according to the first embodiment shown in FIG. This is different from the first embodiment in that the separated body 65 is provided.
- the other components similar to those in the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
- the separator 65 is moved from the state in which the center portion of the upper surface to which the puncture needle cover portion 9 is connected projects toward the upper puncture needle cover portion 9 side in FIG. 26 (b). As shown, it is configured to be deformed so as to be lowered downward, that is, toward the opposite side to the puncture needle cover 9 side.
- the puncture needle cover portion 9 connected to the upper surface center portion can be pulled out from the puncture needle 11 by the deformation operation of the separation body 65, that is, the operation of deforming the upper surface center portion of the separation body 65 from the upper side to the lower side.
- the front end of the lancet body 6 is located on the front side (the lower side in FIG. 26) of the lancet body 6 and the lancet body 6 26 is provided on the front end side (lower side in FIG. 26) of the lancet body 6 having a cylindrical shape. It has a substantially box shape with a bottom surface arranged in a direction orthogonal to the axis of the lancet body 6.
- the separating body 65 includes a base surface portion 66, a side surface portion 67, a movable surface portion 68, and an attachment portion 69.
- the base surface portion 66 is rectangular and has a thin plate shape, and constitutes a bottom surface arranged so as to be orthogonal to the axis of the lancet body 6.
- the side surface portion 67 is rectangular and has a thin plate shape. From the left and right sides It is formed so as to extend vertically to the lancet body 6 side (upper side in FIG. 26)
- the movable surface portion 68 is rectangular and has a thin plate shape, from the rear end sides (upper side in FIG. 26) of the left and right side surface portions 67. Each is formed so as to be movably bent toward the inner side, that is, toward the other movable surface portion 68.
- the attachment portion 69 has a long bar shape, and a base surface on the inner side of the left and right movable surface portions 68.
- the left and right movable surface portions 68 are disposed so as to face the portion 66 and are movably attached to the left and right movable surface portions 68. That is, the left and right movable surface portions 68 form the upper surface of the separator 65, An attachment portion 69 is attached.
- the left and right movable surface portions 68 are inclined inward toward the lancet body 6 so that the attachment portion 69 at the center of the upper surface of the separator 65 protrudes toward the lancet body 6.
- the puncture needle cover portion 9 of the lancet body 6 is connected to the protruding attachment portion 69.
- the base surface portion 66, the side surface portion 67, the movable surface portion 68, and the attachment portion 69 constituting the separating body 65 are integrally formed with the lancet body 6 using synthetic resin, and the separating body 65 and the lancet body 6 are integrated.
- the thin plate-shaped side surface portion 67 formed integrally with the separating body 65 can elastically deform the rear end side, that is, the upper surface portion side of the separating body 65 toward the outside by using its elasticity. It is configured as possible. For this reason, the upper surface central portion of the separator 65 can be deformed from above to below. This deformation operation will be described in detail later.
- a thin portion is provided between the side surface portion 67 and the movable surface portion 68 and between the movable surface portion 68 and the mounting portion 69. For this reason, since these thin portions can smoothly bend (move) between the side surface portion 67 and the movable surface portion 68 and between the movable surface portion 68 and the attachment portion 69, the separating member 65 can be easily deformed. .
- FIGS. 27 (a) to 27 (f) illustrate the puncture needle cartridge 4 ′′ and the puncture device 1. It is a principal part side view, and in order to make an understanding easy, the puncture device 1 and the lancet case 7 are represented by the cross section.
- the puncture needle cover portion 9 has a lancet case that is substantially the same as the protruding portion 70 is protruded. 7 is projected from the front end. For this reason, the puncture needle 11 covered with the puncture needle cover portion 9 is exposed by the same amount as the protrusion of the convex portion 70. Further, when the main body case 2 is pushed down, the left and right movable surface portions 68 incline the inner sides thereof toward the base surface portion 66 side (lower side in FIG. 27). At this time, the side surface portion 67 that has been spread outwardly rapidly returns to its original shape due to its elastic return force.
- the inner side of the movable surface portion 68 is pulled down to the base surface portion 66 side, whereby the mounting portion 69 is also rapidly pulled down to the base surface portion 66 side.
- the puncture needle cover part 9 is completely removed from the broken part 10 part. That is, the puncture needle cover portion 9 is pulled out from the puncture needle 11, and as a result, it is possible to create a state where the puncture needle 11 is exposed at the front end portion of the lancet body 6. (At this time, since the puncturing operation has not yet been performed, the puncture needle 11 is in a state where it exists in the lancet case 7). Thereby, the deformation
- the puncture needle cartridge 4 "of the present embodiment can be easily mounted by simply holding the main body case 2, pressing down and lifting the puncture needle cartridge 4" toward the puncture needle cartridge 4 ".
- the operation can be appropriately performed.
- the puncture needle cartridge 4 ′′ is mounted on the puncture device 1 by the mounting operation described above, the puncture operation is performed and discarded by the discarding operation.
- the separated body 65 once separated is reintroduced into the puncture needle cartridge 4 ′′. Wear and store until disposal. Therefore, as described above, the puncture needle cartridge 4 ′′ according to the present embodiment has a structure that deforms the separating body 65 once used. For this reason, the used puncture needle cartridge 4 shown in FIG. “And the unused puncture needle cartridge 4” shown in FIG. 26 (a) can be easily discriminated. Therefore, the user can discriminate the unused puncture needle cartridge 4 ′′ at the next measurement. Can be used.
- the cartridge 4 ′′ has a structure that deforms the separator 65 once used. For this reason, as shown in FIG. 28, even if the user mistakenly inserts the used puncture needle cartridge 4 "into the main body case 2, the separating member 65 is deformed, and the mounting portion 69 becomes the base surface portion. The puncture needle cover portion 9 connected to the attachment portion 69 is pulled out from the front end of the lancet case 7 toward the base surface portion 66 by the reuse prevention amount A.
- the re-use prevention amount A is pushed against the original push-in amount (that is, the push-in amount of the injection rod 21 to the rear side by the lancet body 6 when the unused puncture needle cartridge 4 is used). Because of the insufficient push-in amount, the movement distance to the rear side of the lock claw 24 behind the injection rod 21 in the main body case 2 is insufficient, and the lock claw 24 is locked. It does not engage with the engaging claw 39 of the body 28. Therefore, the main spring 34 does not reduce the puncture force and the puncture operation is not performed, and as a result, the used puncture needle cartridge 4 Can be prevented from being reused inappropriately.
- the reuse prevention amount A is larger than the exposed length of the puncture needle 11 exposed from the lancet body 6. Therefore, even if the used puncture needle cartridge 4 is accidentally inserted into the main body case 2 and the puncture needle cover portion 9 does not cover the puncture needle 11 as shown in FIG. Since the prevention amount A is made larger than the exposed length of the puncture needle 11, the movement distance of the lock claw 24 behind the injection rod 21 in the main body case 2 can be made short, and the lock claw 24 is engaged with the lock body 28. It does not engage with the pawl 39.
- Embodiments 1 to 3 have been described as examples of the technology disclosed in the present application.
- the technology in the present disclosure is not limited to this, and can also be applied to an embodiment in which changes, replacements, additions, omissions, and the like are appropriately performed.
- the present disclosure relates to a puncture needle cartridge for puncturing a human body and causing blood to flow out in order to measure biological information such as a blood glucose level, a puncture device for attaching the puncture needle cartridge, and a puncture device for the puncture needle cartridge It can be used as a mounting method.
Abstract
Description
すなわち、穿刺器具は、開口部を有する筒状の本体ケースと、この本体ケース内に設けたランセットホルダと、このランセットホルダを本体ケースの前端開口部側に付勢する付勢体と、ランセットホルダをロックするロック爪と、第1の操作ボタンと、第2の操作ボタンとを有する構成となっていた。第1の操作ボタンを操作すると、ロック爪が解除されランセットホルダが本体ケースの前端開口部側に付勢体による付勢により移動する。第2の操作ボタンを操作すると、ランセットホルダからランセットが離脱する。
なお、発明者は、当業者が本開示を十分に理解するために添付図面及び以下の説明を提供するのであって、これらによって特許請求の範囲に記載の主題を限定することを意図するものではない。
図1は、本実施形態の穿刺器具1を示す。穿刺器具1は、例えば血糖値を測定するために、人体に針を穿刺し血液を流出させる器具である。この穿刺器具1は、長い筒状の本体ケース2の前端開口部3に、図2の穿刺針カートリッジ4を装着して穿刺を行う。この穿刺に関する動作には、穿刺針カートリッジ4の装着動作、穿刺動作、穿刺針カートリッジ4の廃棄動作の3つの動作がある。
次に、第2の動作である穿刺動作では、図4に示すように、使用者が穿刺針カートリッジ4を例えば左手の指に押し当て、穿刺器具1を握った右手の親指で本体ケース2の操作ボタン5を押す。この結果穿刺が行われ、左手の指の穿刺した部位に血液を流出させる。
このように、本実施形態においては、穿刺器具1を片手で持った状態で、1つのボタンを操作するだけで、一連の穿刺関連動作(装着動作、穿刺動作、廃棄動作)を行うことが出来る。その結果、穿刺器具1は、きわめて使い勝手がよいものとなり、その結果として、一連の穿刺関連動作の操作性を高めることができる。
以下、図6~図9を用いて、穿刺針カートリッジ4の説明を行い、次に、図10~図12を用いて穿刺器具1の説明を行う。
なお、以下の説明において、特に説明がない場合は、穿刺器具及び穿刺針カードリッジ4の穿刺側を「前」側、穿刺側の反対側を「後」側として説明する。
穿刺針カートリッジ4は、図6に示すように、ほぼ円柱形状のランセット本体6と、ほぼ円筒形状のランセットケース7により構成される。
ほぼ円柱状のランセット本体6は樹脂製で、その後端側に穿刺器具1への接続部8、前端側に円柱状の穿刺針カバー部9、中間部に破断部10を有する。このランセット本体6の破断部10の前後に渡って、ランセット本体6に穿刺針11(図17から図21にも図示)が埋め込まれている。さらに、ランセット本体6の穿刺針カバー部9の外周には、外周方向に向けて突出するガイド突起12(ガイド突起の一例)を180度対向した位置に2個(複数個)設けている。
円筒状のランセットケース7の内面には、図6に示すように、その前端から後方に向けて、螺旋状の案内部13が形成されている。案内部13は、ランセット本体6にランセットケース7が装着されたとき、ランセット本体6の2個のガイド突起12に対応する位置、つまりガイド突起12と同じく180度対向した位置に2個(複数個)形成されている。案内部13が螺旋状に形成されているため、ランセット本体6のガイド突起12が案内部13に挿入され案内されるとき、ランセットケース7がガイド突起12によって旋回力を受ける。
穿刺針カートリッジ4の装着動作時、穿刺器具1の前端部が環状の凹部7aに差し込まれると、この前端部で当接面7bが押され、ランセットケース7は、図9(a)に示すように、前方向(図9の矢印C方向)に摺動させられる。このとき、ランセットケース7の内面側では、図9(b)、(c)に示すように、螺旋状の案内部13がガイド突起12上を摺動するため、このランセットケース7に時計方向(矢印B方向)の旋回力が発生する。つまり、ランセットケース7は、前方向に摺動することでランセット本体6の回りを時計方向に回転する。
このランセットケース7の旋回力により、ランセット本体6の破断部10部分をねじ切って破断させ、穿刺針11を表出させる。
具体的には、時計方向に回転するランセットケース7は、図9(b)に示す摺動溝15の摺動壁面15aに当接するランセット本体6の摺動突起14を時計方向に回動させる。この摺動突起14は、ランセット本体6の破断部10よりも後方側(図9(a)~(c)の上側)を時計方向に回動する。その一方で、前方向に摺動するランセットケース7は、図9(b)、(c)に示すように、その螺旋状の案内部13がランセット本体6のガイド突起12を押し、ランセット本体6の破断部10よりも前方側(図9(a)~(c)の下側)が反時計方向(案内部13の回転方向とは反対方向で、矢印B方向とは反対方向)に回動する。したがって、ランセットケース7が前方向へ摺動すると、穿刺針11が埋め込まれた破断部10は、その前後の接続部によって逆方向の回動力を受け、図9(a)の状態からねじ切りが開始されて、図9(b)から(c)に移行する状態で破断する。
また、上述のごとく、装着動作時には、穿刺針カートリッジ4自体が破断部10の前後部分を逆方向に回動させるので、穿刺針カートリッジ4はただ単に直立させていればよく、穿刺針カートリッジ4を固定しておく必要などはない。その結果として、使い勝手の良いものとなる。
このように、自動的に穿刺針カバー部9を外すことができるので、穿刺針カートリッジ4は、この点からも使い勝手の良いものとなる。
次に、穿刺針カートリッジ4を装着する穿刺器具1について説明する。
図10は、筒形状をした穿刺器具1を軸方向に分解した図である。
本実施形態における穿刺器具1の本体ケース2は、前端開口部3および後端開口部18を有するほぼ筒状体であり、ケースピース2aとケースピース2bから構成されている。この本体ケース2内に収納される部品を、図11を用いて説明する。
本体ケース2内に収納される部品の内、最も大きな部品は、前端側にホルダ挿入筒20(ホルダ挿入筒部の一例)を有するメインロッド19である。このメインロッド19の前側(図11の左側)には、ランセットホルダ22を有する射出ロッド21を装着する。射出ロッド21は、その前端側に、図2の穿刺針カートリッジ4のランセット本体6を装着する円筒形状のランセットホルダ22を有している。
図12は、射出ロッド21に作動ロッド23が装着された状態を、ケースピース2a側から見た図である。
本実施形態の射出ロッド21は、作動ロッド23を本体ケース2の前後方向に摺動自在に装着する。また、作動ロッド23は、作動スプリング27(第3の付勢体の一例)により図10のロック体28方向に付勢している。より詳細には、作動ロッド23の前端側と後端側に、前後方向に長い長孔25を2個設け、この長孔25を射出ロッド21の2個の軸部26に係合させて、作動ロッド23を本体ケース2の前後方向に摺動自在としている。また、この作動ロッド23の前端部と射出ロッド21の後端部を作動スプリング27により連結し、作動ロッド23を後方側へと付勢する、つまり、図10のロック体28方向に付勢する。
そして、図10に示すように、射出ロッド21前端側のランセットホルダ22をメインロッド19のホルダ挿入筒20に差し込むと、射出ロッド21は、メインロッド19により本体ケース2の前後方向に摺動自在に保持される。図10においては、ホルダ挿入筒20に挿入されたランセットホルダ22の先端側の状態がよく分かるようにするため、ホルダ挿入筒20の一部を切り欠いて表示している。
なお、図10では、ロック体28の係合爪39がロック爪24に係合し、射出ロッド21の前方側への摺動(射出)がロックされた状態となっている。このロック体28を回動させることにより穿刺動作と、廃棄動作を切り替えるのであるが、この切り替え動作については、後で詳細に説明する。
この状態でケースピース2aとケースピース2bを合致させる。
以上の構成を有する穿刺針カートリッジ4及び穿刺器具1について、以下、主に図13~図17を用いて「装着動作」を説明し、次に主に図18を用いて「穿刺動作」を説明し、主に図19~図21を用いて「廃棄動作」を説明する。
図13は、本体ケース2の初期状態を示す図である。初期状態とは、使用者が、図3に示すように、穿刺器具1を握り、この穿刺器具1を直立させた穿刺針カートリッジ4に向けて押し下げる前の状態である。
穿刺針カートリッジ4の後方側が、穿刺器具1の前端開口部3から本体ケース2内へ挿入される前は、本体ケース2内では、メインロッド19が、操作ボタン5が内包するボタンスプリング36により前方側へと押される。その結果、メインロッド19に装着した射出ロッド21のケースストッパ当て45が本体ケース2の前ケースストッパ46に当接した位置で、メインロッド19は停止する。このとき、メインロッド19の中央で、メインスプリング34は、射出ロッド21の穿刺カム30を前方側に引っ張る。このため、穿刺カム30は軸支部31を中心に反時計方向(図13における反時計回り方向で、以後、反時計方向と称す)に回転し、その停止爪47を射出ロッド21のリブ48に当接させて停止させている。また、メインスプリング34は、穿刺カム30を介して射出ロッド21を前方側へ引っ張る。射出ロッド21は、穿刺カム30がメインロッド19の穿刺カムストッパ49に当接した位置で、メインロッド19に対して停止する。
穿刺針カートリッジ4が本体ケース2内へ押し込まれると、ランセット本体6が、その接続部8で射出ロッド21のランセットホルダ22に係合される。これにより穿刺針カートリッジ4が穿刺器具1に装着される。穿刺針カートリッジ4が本体ケース2内へさらに押し込まれると、ランセット本体6が射出ロッド21を後方側へと押していく。射出ロッド21が、穿刺カム30、メインスプリング34を介して、メインロッド19を後方側へと押すと、メインロッド19は、その後端部54が本体ケース2のメインロッドストッパ55(図11)に当接して停止する。すると、図14に示す状態となる。さらに射出ロッド21が押し込まれると、射出ロッド21は、停止したメインロッド19内を後方側へと摺動する。このため、射出ロッド21の穿刺カム30はメインスプリング34を引き伸ばし、このメインスプリング34には穿刺力(つまり穿刺のための射出力)が畜力される。
図15は、ランセットケース7がランセット本体6に対して90度旋回した状態(図9の(b)の状態)を示す図である。この時、穿刺針カートリッジ4では、破断部10部分が、ねじ切り寸前の状態となっている。穿刺器具1では、射出ロッド21がさらに後方側へと移動し、作動ロッド23後方側のロック爪24がロック体28の係合爪39に当接する。本実施形態の作動ロッド23は、その後端側のロック爪24でロック体28の係合爪39を、ロック体スプリング41による付勢方向とは反対方向に回動させる。そして、その回動後、ロック体28の係合爪39に対向する作動ロッド23の面、つまり回動阻止部23a(回動阻止部の一例)により係合爪39がロック体スプリング41により付勢方向へ回動するのを阻止される。このため、図15に示す状態から、射出ロッド21が後方へと移動すると、ロック爪24がロック体28の扇下方の係合爪39を押し上げ、係合爪39は反時計方向に回動する。その後、図16に示すように、ロック爪24が係合爪39を押し越すと、係合爪39は時計方向に回動しようとするが、作動ロッド23の回動阻止部23aに当接し回動を停止する。
図17は、穿刺針カートリッジ4の装着動作の完了を示す図である。使用者が、押し下げていた穿刺器具1を持ち上げると、基台部16の板バネ17の蓄力が開放される。この開放力により、穿刺針カバー部9がすでにねじ切られた破断部10部分から弾けるように外される。その結果として、ランセット本体6の前端部分に穿刺針11を表出させることができる。
なお、作動ロッド23を挟んで、係合爪39とは反対側の本体ケース2部分には突起57が設けられている。突起57は作動ロッド23を支持している。
図18は、穿刺動作を示す図である。本実施形態の作動ロッド23は、図17に示すように、作動ロッド23のロック爪24を、ロック体28の扇下方側の係合爪39に係合させている時には、ロック体28の扇上方側の押出爪40を、操作ボタン5の上傾斜面部51に対向する位置に配置している。
ロック状態が解除されると、射出ロッド21は、メインスプリング34に引っ張られて前端開口部3側へと勢いよく発射される。射出ロッド21は、ケースストッパ当て45が前ケースストッパ46に当接するまで摺動する。穿刺器具1の前方側では、射出ロッド21に係合されたランセット本体6の穿刺針11が、穿刺針カートリッジ4の前端から射出される。その結果、使用者の指等に対して穿刺針11が穿刺される。
さらに本実施形態においては、穿刺器具1は、本体ケース2を長筒状とし、この本体ケース2の軸上に、本体ケース2の後端開口部18の内外に摺動自在な操作ボタン5を設け、本体ケース2の軸上で操作ボタン5を摺動させ、これにより穿刺動作を行わせる構成とした。このため、図4に示すように、使用者は、穿刺動作時には、穿刺針カートリッジ4を指に押し当てた状態で、長筒状の本体ケース2を掌で握り込んで安定させ、この安定状態から操作ボタン5を本体ケース2の軸上の穿刺位置に向けて押し込むことができる。その結果として、本実施形態における穿刺針カートリッジ4及び穿刺器具1は、極めて安定的な状態で穿刺を行うことができ、使い勝手の良いものとなる。
図19は、穿刺動作の完了状態を示す図で、廃棄動作の始まりを示す図である。使用者が操作ボタン5から指を離すと、操作ボタン5は内包したボタンスプリング36の復帰力により穿刺動作前の位置まで戻される。本実施形態のメインロッド19には、上述のように、ロック体28が時計方向(ロック体スプリング41の付勢方向)に回動された際に、ロック体28の押出爪40が操作ボタン5の平面部50に対向する位置で回動を止めるロックピース下ストッパ53(ストッパ部の一例)が設けられている。このため、ロック体28の押出爪40は、ロックピース下ストッパ53により、操作ボタン5の平面部50に対向する位置で回動を停止する。したがって、操作ボタン5が再び押し込まれた時には、操作体35は、後述するようにその平面部50で押出爪40を介してロック体28を操作することができる。
本実施形態のロック体28は、その扇下方側の係合爪39の前面側に、作動ロッド23のロック爪24を本体ケース2の前方側に押す押圧面60(押圧面の一例)を設けている。また、本実施形態の射出ロッド21は、上述のように、作動ロッド23を本体ケース2の前後方向に摺動自在に装着する。また、この作動ロッド23は、作動スプリング27によりロック体28方向に付勢されている。このため、図21に示すように、射出ロッド21が停止した状態においても、押圧面60がロック爪24を押し、作動ロッド23を前方側へと摺動させることができる。これにより、メインロッド19とロック体28は前方側への摺動を続けることができる。
その後、使用者が指を操作ボタン5から外せば、メインスプリング34の復帰力によってメインロッド19が後方へと引き戻され、図13に示す初期状態に戻る。すなわち、本実施形態のロック体28は、穿刺動作前に、図17に示すように、押出爪40を操作体35の上傾斜面部51に対向する位置に配置し、廃棄動作前に、図20に示すように、押出爪40を操作ボタン5の平面部50に対向する位置に配置する。このため、ロック体28が、操作ボタン5の動作を二通りの動作、つまり、穿刺動作と廃棄動作に切り換えることができるのである。したがって、図3~図5に示したように、使用者は、一度、本体ケース2の中央部を握ってしまえば、その状態のまま、握りを持ち替えること無く、穿刺針カートリッジ4の装着動作、穿刺動作、廃棄動作を行うことができる。しかも、穿刺動作、廃棄動作は、1つの操作ボタン5で実施することができる。その結果として、一連の穿刺動作を片手の操作で行うことができるため、穿刺器具1は、極めて使い勝手が良く、一連の穿刺関連動作の操作性を高めることができる。
まだ穿刺針カートリッジ4の装着動作に慣れていない使用者が、操作ボタン5に親指を乗せた状態で装着動作を行うと、装着動作の途中で操作ボタン5が押し込まれてしまう時がある。具体的には、図14に示すように、本体ケース2の前方側のランセット本体6がランセットホルダ22を介して射出ロッド21に係合した状態にあるとき、後方側の操作ボタン5が押し込まれる場合がある。この時は、操作ボタン5が、その平面部50、押出爪40を介してロック体28を前方側へ摺動させるので、ロック体28の係合爪39が前方側のロック爪24に当たり、このロック爪24を射出ロッド21に向けて押し込むことになる。つまり、射出ロッド21は、前方からランセット本体6の力を受け、後方から操作ボタン5の力を受けることになる。
以上説明したごとく、本実施形態の穿刺針カートリッジ4は、後端側に穿刺器具1への接続部8、前端側に穿刺針カバー部9、中間部に破断部10を有するランセット本体6と、ランセット本体6の破断部10の前後に渡ってこのランセット本体6に埋め込まれた穿刺針11と、ランセット本体6の中間部外周に装着されたランセットケース7とを備えている。ランセット本体6の穿刺針カバー部9は、外周に向けて突出するガイド突起12を有する。また、ランセットケース7は、その前端から後方に向けて、ガイド突起12によってこのランセットケース7が旋回力を受けるように螺旋状の案内部13を設けている。ランセット本体6の破断部10よりも後方側には外周方向に向けて突出する摺動突起14が設けられている。また、ランセットケース7には摺動突起14を前後方向に摺動案内する摺動溝15が設けられている。
このため、片手で握った穿刺器具1の前端開口部を、ただ単に直立させた穿刺針カートリッジ4に向けて押し下げるだけで、穿刺針カートリッジ4が穿刺器具1に装着されるとともに、その破断部10が破断されて穿刺針11が表出し、穿刺の準備を完了することが出来る。その結果として、穿刺器具1を片手で持った状態で、装着動作を行うことが出来るので、まだ穿刺器具1の扱いに慣れていない人も操作を間違えることが少なくなり、きわめて使い勝手がよく穿刺関連動作の操作性を高めることができる。
図22~図25を参照しながら、実施の形態2に係る穿刺針カートリッジ4´について説明する。
実施の形態2に係る穿刺針カートリッジ4´は、ランセット本体6´に設けた摺動突起14´の形態が実施の形態1とは異なる。その他の実施の形態1と同様の構成については同様の符号を付し、その詳細な説明は省略する。
上述した実施の形態1のランセットケース7は、図20、図21を経て廃棄された状態において、ランセット本体6が前方に摺動した時に、このランセット本体6に設けた摺動突起14の先端を当接させる摺動受61を設けている。このため、穿刺針カートリッジ4の排出後、摺動突起14の先端と摺動受61が当接すると、ランセット本体6は前方側への摺動が止められる。したがって、穿刺針11が穿刺針カートリッジ4から突出することはなく、穿刺針カートリッジ4を安全な状態で取り扱うことができるものとなっている。
本実施の形態2におけるランセット本体6´の摺動突起14´は、図23に示すように、ランセット本体6の軸に沿って延びる鉤形状であり、ランセット本体6´から外方に向けて突出する突出部62(突出部の一例)と、この突出部62に連続して形成された連結部63(連結部の一例)と、この連結部63から前方側(破断部10側)に延びるとともにランセットケース7の摺動受61に当接させる当接部64(当接部の一例)とを設けている。また、当接部64は、図24に示すように、連結部63を中心としてランセット本体6´の軸方向に沿って回動可能に連結部63に連結されている。つまり、連結部63を薄肉とし可撓性を持たせたので、当接部64はランセット本体6´の軸方向に沿って回動自在となっている。
このため、図24に示すように、使用者がさらにランセット本体6´を力一杯に前方側に押し込もうとしても、ランセット本体6´の外表面からランセットケース7の摺動受61までの間隔D1は、折り重なった当接部64の厚さD3aに突出部62の高さD2を加えた大きさよりも小さいので、これ以上、ランセット本体6´が前端側に進むことはない。したがって、穿刺針11が穿刺針カートリッジ4´から出てくることはない。その結果として、廃棄動作後の穿刺針カートリッジ4´を安全な状態で取り扱うことができるものとなる。
以上の通り、実施の形態2に係る穿刺針カートリッジ4´は、実施の形態1の穿刺針カートリッジ4に工夫を加えることにより、特に廃棄動作時の取り扱いをさらに容易にすることができる。
図26~図28を参照しながら、実施の形態3に係る穿刺針カートリッジ4"について説明する。
実施の形態3における穿刺針カートリッジ4"を図26に示す。この穿刺針カートリッジ4"は、図2に示す実施の形態1に係る穿刺針カートリッジ4における基台部16に代えて、ほぼ直方形状をした分離体65を設けた点において、実施の形態1とは異なる。その他の実施の形態1と同様の構成については同様の符号を付し、その詳細な説明は省略する。
さらに、側面部67と可動面部68間、および可動面部68と取付部69間には、薄肉部を設けている。このため、これら薄肉部で、側面部67と可動面部68間、可動面部68と取付部69間をスムーズに折り曲げる(可動させる)ことができるので、分離体65を容易に変形動作させることができる。
以上の構成を有する穿刺針カートリッジ4"について、以下、図27を用いて、その装着動作を説明する。なお、図27(a)~(f)は、穿刺針カートリッジ4"と穿刺器具1の要部側面図であり、理解を容易にするため、穿刺器具1とランセットケース7を断面で表している。
そして、図27(b)に示すように、ランセットケース7の前端側(同図の下側)が、分離体65の上側に突出した取付部69の位置まで摺動すると、破断部10部分がねじ切られる。
さらに、本体ケース2が押し下げられると、左右の可動面部68は、その内方側を基台面部66側(図27の下側)に傾斜させていく。この時、外方へと押し広げられていた側面部67が、その弾性復帰力により、もとの形状へと急激に復帰する。このため、図27(e)に示すように、可動面部68の内方側は基台面部66側に引き下げられ、これにより取付部69も基台面部66側に急激に引き下げられる。すると、穿刺針カバー部9が破断部10部分から完全に外される。つまり、穿刺針カバー部9が穿刺針11から抜き取られた状態となり、結果的にランセット本体6の前端部分に穿刺針11が表出させられた状態をつくることができる。(なお、この時点では、まだ穿刺動作を行っていないので、穿刺針11はランセットケース7内に存在した状態となっている)。これにより、分離体65の変形動作が完了し、これ以降、分離体65はこの変形後の状態を保持する。
その後、使用者が本体ケース2を持ち上げると、図27(f)に示すように、変形後の分離体65が穿刺針カートリッジ4"から分離する。これにより、穿刺針カートリッジ4"の装着動作が完了する。
さらに、穿刺針カートリッジ4"は、上述した装着動作により穿刺器具1に装着された後、穿刺動作が行われ、廃棄動作により廃棄される。一度分離した分離体65を穿刺針カートリッジ4"に再装着し、廃棄まで保管することがある。そこで、本実施形態の穿刺針カートリッジ4"は、上述のごとく、一度使用すると分離体65を変形させる構造としている。このため、一度使用した図26(b)に示す使用済みの穿刺針カートリッジ4"と、図26(a)に示す未使用の穿刺針カートリッジ4"を容易に判別することができる。よって、使用者は、次の測定時に、未使用の穿刺針カートリッジ4"を判別して使用することができる。
以上のように、本出願において開示する技術の例示として、実施の形態1~3を説明した。しかしながら、本開示における技術は、これに限定されず、適宜、変更、置き換え、付加、省略などを行った実施の形態にも適用可能である。また、上記実施の形態1~3で説明した各構成要素を組み合わせて、新たな実施の形態とすることも可能である。
2 本体ケース
2a ケースピース
2b ケースピース
3 前端開口部
4 穿刺針カートリッジ
5 操作ボタン
6 ランセット本体
7 ランセットケース
7a 凹部
7b 当接面
8 接続部
9 穿刺針カバー部
10 破断部
11 穿刺針
12 ガイド突起
13 案内部
14 摺動突起
15 摺動溝
15a 摺動壁面
16 基台部
17 板バネ
18 後端開口部
19 メインロッド
20 ホルダ挿入筒
21 射出ロッド
22 ランセットホルダ
23 作動ロッド
23a 回動阻止部
24 ロック爪
25 長孔
26 軸部
27 作動スプリング
28 ロック体
29 軸部
30 穿刺カム
31 軸支部
32 軸部
33 軸部
34 メインスプリング
35 操作体
36 ボタンスプリング
37 軸部
38 軸支部
39 係合爪
40 押出爪
41 ロック体スプリング
42 ブッシュ
42a 押当面
43 回転リング
44 溝
45 ケースストッパ当て
46 前ケースストッパ
47 停止爪
48 リブ
49 穿刺カムストッパ
50 平面部
51 上傾斜面部
52 下傾斜面部
53 ロックピース下ストッパ
54 後端部
55 メインロッドストッパ
56 後ケースストッパ
57 突起
58 ロックピース上ストッパ
59 ランセット押出面
60 押圧面
61 摺動受
62 突出部
63 連結部
64 当接部
65 分離体
66 基台面部
67 側面部
68 可動面部
69 取付部
70 凸部
Claims (30)
- 穿刺針カートリッジを装着する側である一端側と前記一端側に対向する他端側を有する穿刺器具であって、
前記一端側及び前記他端側に開口部を有する細長状の本体ケース、
前記本体ケース内に設けたメインロッド、
前記メインロッドに装着され、前記一端側にランセットホルダを有する射出ロッド、
前記射出ロッドに装着され、前記他端側に係合部を有する作動ロッド、
前記射出ロッドを、前記一端側方向に付勢する第1の付勢体、
前記本体ケースの前記他端側の開口部の内外に摺動自在に設けた操作棹、及び
前記操作棹と前記射出ロッド間における前記メインロッドの部分に回動自在に軸支されたロック体であって、前記作動ロッドの前記係合部に係合する第1の被係合部と、前記操作棹の前記一端側の部分に当接する第2の被係合部と、前記第1の被係合部を前記係合部に向けて付勢する第2の付勢体と、を有するロック体、
を備える、穿刺器具。 - 前記操作棹は、前記一端側の部分に、前記ロック体の前記第2の被係合部に当接する平面部と、前記平面部に隣接して他端側に延びるとともに前記本体ケースの軸に対し傾斜する面を有する傾斜面部とを有する、
請求項1に記載の穿刺器具。 - 前記メインロッドは、前記ロック体が前記第2の付勢体の付勢方向に回動するとき、前記ロック体の前記第2の被係合部を前記操作棹の平面部に対向する位置に停止させる第1のストッパ部を有する、
請求項2に記載の穿刺器具。 - 前記作動ロッドは、前記係合部により前記ロック体の前記第1の被係合部を前記第2の付勢体の付勢方向とは反対方向に回動させた後、前記第1の被係合部が前記付勢方向へ回動することを阻止する回動阻止部を有する、
請求項1から3のいずれか一つに記載の穿刺器具。 - 前記作動ロッドの前記係合部が前記ロック体の前記第1の被係合部に係合したとき、前記ロック体の前記第2の被係合部は、前記操作棹の前記傾斜面部に対向する位置にある、
請求項2から4のいずれか一つに記載の穿刺器具。 - 前記本体ケースは、前記ロック体の前記第2の被係合部が前記操作棹の前記傾斜面部によって前記第2の付勢体の付勢方向とは反対方向に回動されたとき、前記反対方向への回動を止める第2のストッパ部を有する、
請求項2から5のいずれか一つに記載の穿刺器具。 - 前記本体ケースは長筒状であり、
前記操作棹は、前記本体ケースの軸上で摺動可能である、
請求項1から6のいずれか一つに記載の穿刺器具。 - 前記ロック体は、前記メインロッドの部分であって前記操作棹の前記平面部及び前記傾斜面部に対向する位置に軸支された、
請求項2から7のいずれか一つに記載の穿刺器具。 - 前記メインロッドは、前記一端側において、前記射出ロッドの前記ランセットホルダを収納するホルダ挿入筒部を有し、
前記ホルダ挿入筒部は、前記一端側において、ランセットを押し出す押出面を有する、
請求項1から8のいずれか一つに記載の穿刺器具。 - 前記ロック体の前記第1の被係合部は、前記作動ロッドの前記係合部を前記一端側方向に押す押圧面を有する、
請求項1から9のいずれか一つに記載の穿刺器具。 - さらに第3の付勢体を備え、
前記作動ロッドは、前記射出ロッドに沿って前後方向に摺動自在に装着され、前記第3の付勢体により前記他端側方向に付勢された、
請求項1から10のいずれか一つに記載の穿刺器具。 - 前記ロック体は、前記穿刺針カートリッジの装着動作によって、前記第2被係合部が前記操作棹の前記平面部に対向する位置から前記傾斜面部に対向する位置に移動するように、回動する、
請求項2に記載の穿刺器具。 - 前記ロック体は、前記第2被係合部が前記操作棹の前記傾斜面部に対向する位置から前記第2の付勢体の付勢方向とは反対方向へ回動することにより、前記穿刺器具の穿刺動作を実行する、
請求項2に記載の穿刺器具。 - 前記穿刺針カートリッジの廃棄動作を実行するとき、前記ロック体は前記第2の付勢体の付勢方向への回動を規制された状態で第2被係合部が前記操作棹の前記平面部に当接する、
請求項2に記載の穿刺器具。 - 請求項1から14のいずれか一つに記載の穿刺器具を使用する方法であって、
前記本体ケースの前記一端側の開口部に、前記穿刺針カートリッジのランセットを挿入し、前記穿刺器具の前記射出ロッドの前記ランセットホルダに前記ランセットを装着することにより前記穿刺針カートリッジを前記穿刺器具に装着し、
前記操作棹を前記本体ケースの前記一端側方向に移動させることにより、穿刺動作を行い、
前記穿刺動作後、前記操作棹を前記本体ケースの前記一端側方向に移動させることにより、前記ランセットを前記ランセットホルダから外して前記本体ケースの前記一端側の開口部より前記穿刺針カートリッジを廃棄する、
穿刺器具の使用方法。 - 穿刺針を突出させる一端側と前記一端側に対向する他端側とを有する穿刺針カートリッジであって、
中間部に破断部を有するランセット本体、
前記ランセット本体の破断部の前後に渡って前記ランセット本体に埋め込まれた穿刺針、
前記ランセット本体の前記一端側に設けられた穿刺針カバー部、
前記ランセット本体の前記他端側に設けられた前記穿刺器具への接続部、
前記ランセット本体の外周に装着されたランセットケース、
前記穿刺針カバー部上に突出するガイド突起、
前記ランセットケースの前記一端側から前記他端側に向けて形成され、前記ランセットケースが旋回力を受けるようにして前記ガイド突起を案内する螺旋状の案内部、
前記ランセット本体の前記破断部よりも前記他端側寄りに形成され外側に向けて突出する摺動突起、及び
前記ランセットケースに形成され前記摺動突起を案内する摺動溝、
を備える、穿刺針カートリッジ。 - 前記ガイド突起は、穿刺針カバー部の外周に複数個設けた、
請求項16に記載の穿刺針カートリッジ。 - 前記案内部は、複数の前記ガイド突起に対応する位置に複数個設けた、
請求項17に記載の穿刺針カートリッジ。 - 前記摺動突起は、前記ランセット本体の外周に複数個設けた、
請求項18に記載の穿刺針カートリッジ。 - 前記ランセット本体は、前記一端側に基台部を有し、
前記基台部は、前記ランセットケースの前記一端側と対向する側に弾性体を有する、
請求項16から19のいずれか一つに記載の穿刺針カートリッジ。 - 前記基台部は、前記穿刺針カバー部よりも大きい断面積を有する、
請求項20に記載の穿刺針カートリッジ。 - 更に、前記ランセット本体の前記一端側には、前記ランセット本体の前記破断部より分離可能な分離体を備え、
前記分離体は、前記穿刺針と対向する面を有する基台面部と、前記基台面部の面に直交する面を有し前記基台面部の両側より前記ランセット本体側に向けて延設された側面部と、前記基台面部に対向する面を有し前記側面部それぞれより互いに向けて延設された可動自在の可動面部と、前記可動面部の対向する端部間に可動自在に取り付けられた取付部と、を有し、
前記可動面部の対向する端部側をランセット本体側に突出させた状態で、前記取付部と前記ランセット本体とを一体化し、
前記分離体の前記側面部は、外方に向けて変形可能である、
請求項16から19のいずれか一つに記載の穿刺針カートリッジ。 - 前記基台面部、前記側面部、前記可動面部、及び前記取付部は、合成樹脂により一体形成した、
請求項22に記載の穿刺針カートリッジ。 - 前記側面部と前記可動面部間、および前記可動面部と前記取付部間は、薄肉に形成した、
請求項23に記載の穿刺針カートリッジ。 - 前記分離体は、前記ランセット本体とともに合成樹脂により一体形成した、
請求項23または24に記載の穿刺針カートリッジ。 - 前記ランセットケースは、内周部に、前記ランセット本体が前記一端側に摺動したときに前記摺動突起を当接させる摺動受を有する、
請求項16から25のいずれか一つに記載の穿刺針カートリッジ。 - 前記摺動突起は、前記ランセット本体から前記ランセット本体の軸を横切る方向である第1の方向に突出する突出部と、前記突出部に連結された連結部と、前記連結部から前記一端側方向に延び前記ランセットケースの前記摺動受に当接可能な当接部と、を有し、
前記連結部は、前記当接部が前記ランセット本体の軸方向である第2の方向に沿って回動自在に連結され、
前記第1方向における前記ランセット本体の外表面から前記ランセットケースの前記摺動受までの長さは、前記摺動突起の突出部が前記第1の方向に突出する長さと前記当接部の前記第1の方向の長さとを加えた長さよりも小さい、
請求項26に記載の穿刺針カートリッジ。 - 前記摺動突起は長形状であり、前記連結部の曲げ強さは、前記突出部および前記当接部よりも弱く形成した、
請求項27に記載の穿刺針カートリッジ。 - 前記ランセット本体の前記摺動突起を前記ランセットケースの前記摺動受に当接させた状態で、前記ランセット本体の前記ガイド突起を前記ランセットケースの螺旋状の前記案内部に当接させる、
請求項26から28のいずれか一つに記載穿刺針カートリッジ。 - 請求項16から29のいずれか一つに記載の穿刺針カートリッジ及び請求項1から14のいずれか一つに記載の穿刺器具を使用する方法であって、
前記穿刺器具の前記一端側の開口部を、前記穿刺針カートリッジのランセットに向けて挿入し、前記穿刺器具の前記射出ロッドの前記ランセットホルダに前記ランセットを装着することにより前記穿刺針カートリッジを前記穿刺器具に装着し、
前記操作棹を前記本体ケースの前記一端側方向に移動させることにより、穿刺動作を行い、
前記穿刺動作後、前記操作棹を前記本体ケースの前記一端側方向に移動させることにより、前記ランセットを前記ランセットホルダから外して前記本体ケースの前記一端側の開口部より前記穿刺針カートリッジを廃棄する、
穿刺針カートリッジの使用方法。
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US15/993,502 US11147484B2 (en) | 2012-11-30 | 2018-05-30 | Puncture instrument, puncture needle cartridge mounted in puncture instrument, and method for using puncture instrument and puncture needle cartridge |
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