WO2016152949A1 - Medical needle - Google Patents

Medical needle Download PDF

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Publication number
WO2016152949A1
WO2016152949A1 PCT/JP2016/059286 JP2016059286W WO2016152949A1 WO 2016152949 A1 WO2016152949 A1 WO 2016152949A1 JP 2016059286 W JP2016059286 W JP 2016059286W WO 2016152949 A1 WO2016152949 A1 WO 2016152949A1
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WO
WIPO (PCT)
Prior art keywords
needle
needle body
medical
protector
medical needle
Prior art date
Application number
PCT/JP2016/059286
Other languages
French (fr)
Japanese (ja)
Inventor
仲宜子
田畑安司
赤池伸和
山崎裕輔
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2016152949A1 publication Critical patent/WO2016152949A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to a medical needle having a structure that ensures airtightness and sterility of a space in which the needle body is disposed before the needle body is used.
  • a blood outlet is constructed by puncturing and placing a dedicated blood collection needle on a donor, and blood is stored in a blood bag connected to the blood outlet.
  • the used blood collection needle is discarded after blood donation is completed to prevent infection.
  • a medical needle equipped with a protector that accommodates a needle body has been developed and provided.
  • this type of medical needle is sterilized with a needle body, a protector, a cap that covers the needle body, and the like assembled before providing the product.
  • high-pressure steam sterilization autoclave sterilization
  • blood collection needles for whole blood see JP-A-8-182741.
  • the needle body of a medical needle is a part that is directly inserted into a blood vessel, and is required to be hygienic even if it is stored for a long time before use. Therefore, the medical needle has high airtightness so that water does not adhere to the needle body during high-pressure steam sterilization and it cannot come into contact with the outside air during the product storage period (that is, steam or outside air does not reach the needle body). It is calculated
  • the present invention has been made in view of the above circumstances, and by blocking a portion that may communicate with the space in which the needle body is arranged in an assembled state, the high-pressure steam sterilization process or the high-pressure steam sterilization process It aims at providing the medical needle which can improve the hygiene of a needle body later.
  • a medical needle accommodates a needle body, a needle holding section that holds the needle body, and the needle holding section in a state before puncturing the needle body.
  • a protector having an accommodation space for accommodating the needle body in association with relative movement in the proximal direction of the needle holding portion after puncturing, and the needle body is disposed between the needle holding portion and the protector. Is provided with a blocking portion for blocking the flow of fluid.
  • the medical needle is provided with a blocking part between the needle holding part and the protector, so that a fluid (steam or outside air) is generated between the needle holding part and the protector during the high-pressure steam sterilization process or after the high-pressure steam sterilization process. ) Can be blocked from flowing. That is, in the medical needle, the portion communicating with the space in which the needle body is arranged in the assembled state is blocked and the vapor and the outside air are prevented from reaching the space in which the needle body is arranged. There is no effect, and the hygiene of the needle body can be improved.
  • a fluid steam or outside air
  • the fitting body is provided with a cap that is attached to the protector before the needle body is punctured and covers the needle body, and the protector is formed of an elastic body at least at the attachment position of the cap and is configured as the blocking portion.
  • the needle holding portion is in close contact with the entire inner peripheral surface of the fitting portion, and the cap is in close contact with the entire outer peripheral surface of the fitting portion It is good to be.
  • the medical needle is in a state before the needle body is punctured, and the needle holding portion is in close contact with the entire inner peripheral surface of the fitting portion made of the elastic body of the protector, and the cap is the outer periphery of the fitting portion.
  • the medical needle can prevent the fluid from entering the cap and can perform the high-pressure steam sterilization process satisfactorily. As a result, the liquid does not adhere to the needle body after the treatment, and the outside air contact during long-term storage can be completely blocked.
  • the fitting portion may be sandwiched between the needle holding portion and the cap in a state before the needle body is punctured.
  • the fitting portion is sandwiched between the needle holding portion and the cap, so that the flesh portion moves elastically, and a gap is formed between the needle holding portion and the fitting portion and between the cap and the fitting portion. It can be closely attached.
  • the protector includes the rigid housing cylinder that surrounds the tip of the needle body in the housing state of the needle body, and the fitting portion that is attached to the housing cylinder and protrudes in the distal direction from the housing cylinder. It is preferable to provide an elastic member.
  • the medical needle can easily provide the fitting portion at the mounting position of the cap.
  • the elastic member is configured as a wing member having a shaft portion attached to the housing cylinder and a wing protruding outward in the width direction from the shaft portion, and the fitting portion is integrally formed with the shaft portion. It is preferable that
  • the fitting portion and the shaft portion are integrally formed, the fitting portion is easily configured as the wing member is formed.
  • the medical needle has a reduced number of parts and can improve airtightness while improving work efficiency during assembly and reducing manufacturing costs.
  • the inner surface of the protector and the outer surface of the needle holding portion are in contact with each other on the proximal end side of the storage space before the needle body is punctured, thereby It is preferable to form a blocking structure that suppresses the inflow of fluid to the distal end side.
  • the needle holding part and the protector have a closed structure on the proximal end side of the storage space, so that when high-pressure steam sterilization is performed, entry of steam into the storage space on the distal end side than the closed structure is suppressed. can do. Therefore, the hygiene of the needle holder is also improved.
  • the closing structure is configured such that a tapered protruding end surface of the closing wall protruding from the outer surface of the needle holding portion comes into contact with a tapered inner surface of the protector.
  • the protruding end surface of the needle holding portion and the inner surface of the protector are brought into contact with each other in a tapered shape, whereby a closed structure can be easily formed and the needle holding portion can be easily moved in the proximal direction.
  • the outer peripheral surface of the needle holding portion is provided with a sealing member made of an elastic body configured as the blocking portion and in contact with the entire circumference of the inner peripheral surface of the protector before the needle body is punctured. May be.
  • the seal member provided in the needle holding portion contacts the entire circumference of the inner peripheral surface of the protector, so that the seal member airtightly closes the accommodation space on the tip side with respect to the contact portion with the protector. Therefore, the medical needle can further improve the hygiene of the needle body during the high-pressure steam sterilization process or after the high-pressure steam sterilization process.
  • the seal member is disposed at a proximal end position in the accommodation space in a state before the needle body is punctured.
  • the medical needle when the seal member is arranged at the proximal end position in the accommodation space, the medical needle is a space in which the needle holding portion extends on the distal end side from the seal member when performing the high-pressure steam sterilization process.
  • the intrusion of fluid can be prevented.
  • the seal member can be easily removed from the accommodation space during the relative movement of the needle body in the proximal direction, thereby facilitating the retraction of the needle holding portion.
  • the protector has a proximal end diameter-enlarged portion that is expanded radially outward from the distal end portion of the protector, and the seal member is in the state before the needle body is punctured, It is good to arrange inside.
  • the seal member By disposing the seal member inside the base end enlarged diameter portion of the protector, the base end side of the accommodation space is widened, so that a relatively large seal member can be applied. For this reason, the seal member can be easily assembled to the needle holding portion, and the adhesion to the inner peripheral surface of the protector is increased.
  • the seal member may be disposed at a distal end side position in the accommodation space in a state before the needle body is punctured.
  • the seal member can airtightly block the space in which the needle body is disposed. Adhesion can be avoided.
  • the protector includes a storage cylinder that constitutes the storage space, and the protection cylinder is configured as the blocking section in contact with the needle holding section in a state before the needle body is punctured.
  • a sealing member made of an elastic body that seals the inner peripheral surface of the housing cylinder over the entire circumference may be provided.
  • the medical needle is sealed in the space in which the needle body that may communicate with the distal end side of the housing space is arranged by sealing the inner peripheral surface of the housing cylinder of the protector over the entire circumference. , It is possible to reliably prevent the fluid from entering.
  • the sealing member penetrates the needle body on the inner peripheral surface of the housing cylinder before the needle body is punctured, and the needle body is inserted into the needle body after the needle body is punctured. It is good to arrange
  • the medical needle is disposed in the accommodation space closer to the base end side than the sealing member after the needle body is punctured, thereby suppressing the scattering of blood adhering to the needle body after the accommodation. Inconveniences such as contamination can be suppressed.
  • the sealing member is in contact with the outer peripheral surface of the needle body before the needle body is punctured, and further penetrates the needle body in a state where the needle body is accommodated in the accommodation space. It is preferable that the portion is narrowed or closed inside.
  • the medical needle is more distal than the sealing member when the sealing member accommodates the needle body in the accommodation space and the portion through which the needle body penetrates narrows or closes inward.
  • the blood can be prevented from flowing out into the body, and the hygiene after puncture is further improved.
  • the protector may have a blood reservoir part for storing blood away from the needle body on the tip side of the arrangement position of the sealing member.
  • the protector has a blood reservoir, so that when the sealing member wipes the blood of the needle body when the sealing member is retracted, the blood flows in the distal direction of the sealing member.
  • the blood pool can prevent blood from flowing out.
  • the sealing member is in contact with the entire outer peripheral surface of the needle holding portion in a state before the needle body is punctured.
  • the sealing member comes into contact with the entire outer peripheral surface of the needle holding portion, so that the meat portion moves between the needle holding portion and the protector so as to fill the gap. Therefore, it is possible to reliably block the fluid from heading toward the storage space on the tip side of the tip of the needle holder during the high-pressure steam sterilization process.
  • the said sealing member consists of a member different from the said storage cylinder.
  • the medical needle can be easily provided at a desired position of the protector because the sealing member is made of a separate member from the housing cylinder, and the labor and manufacturing cost during manufacturing can be reduced. be able to.
  • a cap that covers the needle body may be in close contact with the tip of the protector over the entire outer peripheral surface of the tip.
  • the hygienic properties of the needle body at the time of high-pressure steam sterilization treatment or after high-pressure steam sterilization treatment by blocking a portion that may communicate with the space where the needle body is arranged in the assembled state. Can be increased.
  • FIG. 3A is a perspective view showing a medical needle before use
  • FIG. 3B is a perspective view showing a medical needle during use
  • FIG. 3C is a perspective view showing a medical needle after use.
  • 4A is a partial plan sectional view of the medical needle in use
  • FIG. 4B is a sectional view taken along line IVB-IVB in FIG. 4A
  • 5A is a plan view of the medical needle after use
  • FIG. 5B is a cross-sectional view taken along line VB-VB of FIG. 5A.
  • FIG. 8A is a partial plan sectional view of the medical needle of FIG. 7, and FIG. 8B is a sectional view taken along line VIIIB-VIIIB of FIG. 8A. It is sectional drawing explaining the effect of the medical needle of FIG. It is sectional drawing which shows the medical needle which concerns on a 1st modification. It is sectional drawing which shows the medical needle which concerns on a 2nd modification. It is a disassembled perspective view of the medical needle which concerns on 3rd Embodiment of this invention. It is side surface sectional drawing of the medical needle of FIG.
  • FIG. 14A is a cross-sectional view for explaining the action and effect of the medical needle of FIG. 12 during high-pressure steam sterilization
  • FIG. 14B is a cross-sectional view for explaining the action and effect of the medical needle of FIG. 12 after puncturing.
  • . 15A is a partial cross-sectional view showing a protector according to a third modification
  • FIG. 15B is a partial cross-sectional view showing a protector according to a fourth modification
  • FIG. 15C shows a protector according to a fifth modification. It is a fragmentary sectional view shown.
  • the medical needle 10 according to the first embodiment of the present invention is used for blood donation, and is configured as a blood collection needle for whole blood that collects a certain amount of all blood components of a blood donor.
  • the medical needle 10 accommodates a needle body 12 (canula), a hub 14 (needle holding portion) for holding the needle body 12, and a needle body 12 punctured by a blood donor.
  • Protector 16 Note that the configuration of the medical needle 10 according to the present embodiment is not limited to the whole blood blood collection needle, but may be applied to a component blood collection needle, and may be applied to a drug injection needle or the like. Also good.
  • the medical needle 10 is configured as a winged indwelling needle (so-called winged needle).
  • the pair of wings 22 of the medical needle 10 serves as a gripping part that is held by a medical worker such as a doctor or a nurse and performs a puncturing operation of the needle body 12, and is spread on the body surface of the blood donor during blood collection. It becomes a fixing part used when fixing with a bandage.
  • the protector 16 of the medical needle 10 includes an accommodation cylinder 18 and a shaft portion 74 of a wing member 20 (elastic member) attached to the accommodation tube 18, and the wing 22 is integrally formed with the shaft portion 74. ing.
  • the configuration of the medical needle 10 according to the present embodiment can also be applied to needles other than those with wings.
  • the medical needle 10 is a part of a blood collection set in the product provision state shown in FIG. 3A (hereinafter also referred to as “before use”). Specifically, in a state where the hub 14 and the protector 16 are assembled to each other, a tube 26 connected to a blood bag (not shown) is connected and fixed to the proximal end of the hub 14. In the medical needle 10, the needle body 12 protrudes from the tip of the protector 16, and the needle body 12 is covered with a cap 24.
  • the medical staff When blood is collected (hereinafter also referred to as in use), as shown in FIG. 3B, the medical staff removes the cap 24, and the exposed needle body 12 is punctured into the blood vessel of the blood donor. As a result, the medical needle 10 becomes a blood lead-out portion that collects the blood of the blood donor, blood flows out into the lumen 27 of the tube 26, and further, blood is supplied to the blood bag through the lumen 27.
  • the medical staff pulls out the needle body 12 from the blood donor, and the needle body 12 is housed in the protector 16 as shown in FIG. 3C. Discarded.
  • the medical needle 10 that performs this operation will be described in detail.
  • the needle body 12 of the medical needle 10 has a long hollow tube having rigidity that can be punctured from the skin of the blood donor to the inside of the blood vessel.
  • a sharp needle tip 28 is formed at the tip of the needle body 12, and the needle tip 28 is provided with an opening 28a through which blood can flow.
  • a flow path 30 is provided which communicates with the opening 28 a and allows blood to flow along the axial direction of the needle body 12.
  • the thickness of the needle body 12 is not particularly limited, but may be designed in consideration of shortening the blood donation time and reducing the fear of the donor.
  • the outer diameter of the needle body 12 is set to 1.25 mm.
  • the length of the needle body 12 may be designed in consideration of improvement in operability and reduction in fear of the patient.
  • the length of the portion protruding from the hub 14 is preferably 40 mm or less. is there.
  • the constituent material of the needle body 12 include a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy.
  • the hub 14 holding the needle body 12 is formed in a cylindrical shape having an axis coaxial with the axis of the needle body 12, and the base end portion of the needle body 12 is formed. It is connected and fixed.
  • the hub 14 engages with the protector 16 before and during use so that the hub 14 can be handled integrally.
  • the hub 14 is disengaged and retracted relative to the protector 16 after use, so that the needle body 12 is retracted. It arrange
  • hollow portions 32 that continue to the openings 14 a and 14 b at both ends of the hub 14 and pass through the shaft center.
  • a tapered portion 34 having a small diameter in the proximal direction from the opening portion 14 a on the front end side is formed by the inner wall of the hub 14.
  • the needle body 12 is firmly fixed by being injected with the adhesive 36.
  • the hollow portion 32 on the proximal end side with respect to the tapered portion 34 is formed to have a slightly larger diameter, and serves as a communication passage 38 that communicates with the flow passage 30 of the needle body 12 that is fixed.
  • the hub 14 is formed by integrally forming a shaft portion 40 accommodated in the protector 16 and an operation portion 42 that is connected to the proximal end side of the shaft portion 40 and exposed to the outside of the protector 16 before and during use. Composed.
  • the shaft portion 40 is slidably disposed in the protector 16 and has an overall length that is slightly longer than the axial length of the protector 16.
  • a locking portion 44 is provided at the distal end side position
  • a closing portion 46 is provided at the proximal end side position.
  • the locking portion 44 includes an annular protrusion 44a that protrudes radially outward on the distal end side, and an annular hook portion 44b that protrudes radially outward at a position spaced from the annular protrusion 44a in the proximal direction.
  • the annular protrusion 44a is formed in a quadrangular shape in a sectional view (see FIG. 4B), and the annular hook portion 44b is formed in a substantially right triangle shape having an inclination on the base end side in the sectional view.
  • the closing portion 46 is formed on the outer peripheral surface of the shaft portion 40 in a conical shape that gradually increases in diameter toward the base end direction of the hub 14.
  • the blocking part 46 has a plurality of (four) cutout parts 46 a along the circumferential direction of the shaft part 40.
  • the notch 46a extends from the tip having a conical shape to the front of the base end of the closing portion 46, and the outer peripheral surface of the shaft portion 40 is exposed.
  • a proximal end side of the cutout portion 46a constitutes a disc-shaped blocking wall 46b that is continuous over the entire circumference of the shaft portion 40 in the circumferential direction.
  • the blocking wall 46 b has a tapered protruding end surface 47 a that protrudes radially outward from the hub 14.
  • the projecting end surface 47 a contacts the tapered inner surface 47 b of the peripheral wall 58 constituting the housing space 60 in a state where the hub 14 is housed in the protector 16.
  • the operation part 42 is connected to the shaft part 40, and in a plan view (see FIG. 4A), a base part 48 having a narrow front end side and a wide base end side, and a base end side of the base part 48 in the front end direction. And a pair of protruding arms 50.
  • the base end surface of the base portion 48 is provided with a base end opening portion 14b communicating with the hollow portion 32 at an axial center position and an annular connection groove 52 that circulates around the radially outer side of the opening portion 14b.
  • the connection groove 52 fits and holds the tube 26 (see FIG. 3A), and allows the communication path 38 of the hub 14 and the lumen 27 of the tube 26 to communicate with each other.
  • the base 48 may be integrally formed with the hub 14 as shown in the drawing, or may be configured separately.
  • the arm 50 includes a claw portion 50a that protrudes outward in the width direction on the distal end side, and an operation protrusion 50b that protrudes outward in the width direction on the base end side spaced from the claw portion 50a.
  • the claw portion 50 a is inserted into the protector 16 and engages with the engagement hole 70 of the protector 16 before and during use. Thereby, the hub 14 and the protector 16 are integrated.
  • the operation protrusion 50b is a part that is exposed from the protector 16 and pressed by a medical worker. That is, the pair of arms 50 is elastically deformed inward by pressing of the pair of operation protrusions 50b by a medical worker. For this reason, the claw portions 50a on the distal end side come close to each other and release the engagement with the protector 16, so that the hub 14 together with the needle body 12 can be retracted relative to the protector 16.
  • the hub 14 is preferably made of a relatively hard resin material.
  • thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and polyvinyl chloride can be suitably used.
  • the hub 14 of this embodiment employs polycarbonate, which is a material having high heat resistance, hygiene, and water repellency.
  • the protector 16 of the medical needle 10 has a function of accommodating the needle body 12 after blood collection is finished (after use) and preventing the needle tip 28 from being pierced.
  • the housing cylinder 18 of the protector 16 is formed by a cylindrical peripheral wall 58 and has a first space 62 inside which is a part of the housing space 60 of the needle body 12.
  • the axial length of the storage cylinder 18 is longer than the axial length of the portion of the needle body 12 protruding from the hub 14 so that the needle tip 28 is positioned in the first space 62 as the needle body 12 is received. (See also FIG. 5B).
  • the resin material raised in the hub 14 may be appropriately adopted.
  • the housing cylinder 18 of this embodiment employs polycarbonate in the same manner as the hub 14.
  • the storage cylinder 18 includes an attachment cylinder part 64 for attaching the wing member 20, an extension cylinder part 66 that extends to the proximal end of the attachment cylinder part 64 and extends in the proximal direction. It has a locking cylinder part 68 which is connected to the base end of the cylinder part 66 and formed on the radially outer side with a slightly larger diameter.
  • the attachment cylinder part 64 is formed to be slightly thinner than the extension cylinder part 66, and the wing member 20 is tightly fixed to the outer peripheral surface thereof.
  • the level difference between the attachment cylinder part 64 and the extension cylinder part 66 defines the attachment position of the wing member 20.
  • the distal end side of the mounting cylinder portion 64 is positioned in the vicinity of the peripheral wall 58 with the annular protrusion 44a and the annular hook portion 44b in a state where the hub 14 is accommodated in the first space 62. The coaxiality of the heart is ensured and the posture of the needle body 12 is stabilized.
  • the locking cylinder portion 68 is formed so as to taper from the boundary portion of the extending cylinder portion 66 toward the proximal end, and to reach the proximal end from the middle position with the same outer diameter.
  • a pair of engagement holes 70 are formed in the peripheral wall 58 of the locking cylinder portion 68 to hook the claw portion 50a of the hub 14.
  • the latching structure of the protector 16 and the hub 14 is not specifically limited, For example, you may provide the surrounding wall 58 with the recessed part and groove part which can hook the nail
  • the inclined projecting end surface 47a of the blocking wall 46b of the hub 14 is in surface contact with the tapered inner surface 47b of the locking cylinder portion 68 over the entire circumference in the circumferential direction. That is, the projecting end surface 47a of the hub 14 and the inner surface 47b of the housing cylinder 18 constitute a closing structure 47 that closes the housing space 60 on the tip side of the closing wall 46b.
  • the accommodating cylinder 18 has a plurality (four in the present embodiment) protruding in the base end direction and the axial center side of the first space 62 at the boundary between the extending cylinder part 66 and the locking cylinder part 68.
  • An elastic piece 72 is provided.
  • the four elastic pieces 72 are provided at equal intervals (90 ° out of phase) along the circumferential direction of the protector 16.
  • the elastic piece 72 is shaped so that the protruding end is elastically shifted toward the axial center side of the housing cylinder 18.
  • an engagement groove 72a that engages with the annular protrusion 44a when the hub 14 is retracted is formed at a predetermined position (near the connecting portion with the peripheral wall 58) of the surface facing the axis of the elastic piece 72.
  • the four elastic pieces 72 are accommodated in the four cutout portions 46a formed in the closing portion 46 of the hub 14 before and during use. As a result, the hub 14 is restricted from rotating relative to the protector 16, and rattling is suppressed by the four elastic pieces 72.
  • the wing member 20 of the protector 16 is firmly fixed to the mounting cylinder portion 64 of the housing cylinder 18.
  • the wing member 20 is made of a resin material that is higher in flexibility and elastic modulus than the housing cylinder 18 (that is, made of an elastic body).
  • the elastic body constituting the wing member 20 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber (especially those subjected to vulcanization treatment).
  • styrene elastomers hydrogenated styrene elastomers, polyolefins such as polyethylene, polypropylene, polybutene, and ⁇ -olefin copolymers in these styrene elastomers, liquid paraffin, oils such as process oil, talc, cast , Powdered inorganic materials such as mica, polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, or mixtures thereof. . Since the wing member 20 is formed more flexibly than the accommodating cylinder 18 in the medical needle 10, the contact with the body surface of the blood donor can be weakened in the indwelling state, and the burden on the blood donor can be reduced.
  • the wing member 20 is connected to a shaft portion 74 attached to the mounting cylinder portion 64 and a pair of lower portions (body surface fixing scheduled portions) of the shaft portion 74 and projecting outward in the width direction. It has the wing 22 and the front-end
  • the shaft portion 74 of the wing member 20 constitutes a part of the protector 16.
  • the shaft portion 74 is formed to have a length that is thicker than the mounting tube portion 64 of the housing tube 18 and matches the axial length of the mounting tube portion 64.
  • An attachment hole 74 a that is in close contact with the outer peripheral surface of the attachment cylinder portion 64 is provided inside the shaft portion 74.
  • the pair of wings 22 includes a thin portion 82 that is thinly connected to the shaft portion 74, and an outer wing portion 84 that is connected to the protruding side of the thin portion 82 and is thicker than the thin portion 82.
  • the pair of wings 22 protrude outward in the width direction of the shaft portion 74 in a normal state where the pair of wings 22 is not operated by a medical worker. Then, when the needle body 12 is punctured, a pair of outer wing portions 84 are put together and picked up by the medical staff above the shaft portion 74, so that the puncture operation of the needle body 12 is favorably performed.
  • the thin-walled portion 82 can be elastically deformed with a weak force, and the upper side surface is deformed toward the shaft portion 74 at the time of puncturing.
  • the distal end edges of the thin wall portion 82 and the outer wing portion 84 are inclined toward the proximal direction so that the needle body 12 and the distal end portion 76 can be easily seen during puncturing.
  • the pair of outer wing portions 84 are formed in a rectangular shape protruding in the proximal direction from the thin portion 82 in plan view.
  • a plurality (two in this embodiment) of convex portions 84a that are long in the width direction of the wing member 20 are formed on one of the facing surfaces where the pair of outer wing portions 84 come into contact with each other.
  • a plurality (two) of concave portions 84b that are long in the width direction are formed at positions corresponding to the convex portions 84a. Therefore, in the wing member 20, the shift between the outer wing portions 84 is suppressed in a state where the pair of outer wing portions 84 are overlapped.
  • the front end portion 76 is a cylindrical portion that protrudes from the front end surface of the shaft portion 74 in the front end direction.
  • the cap 24 shown in FIG. 3A is attached to the tip 76 before use.
  • a second space 86 that communicates with the first space 62 and forms the accommodation space 60 together with the first space 62 is formed inside the distal end portion 76 in a state where the accommodation cylinder 18 is attached.
  • the distal end portion 76 has a peripheral wall 88 (wall portion) that surrounds the second space 86 in the circumferential direction, and is slightly tapered at the proximal end side connecting portion 90 that continues to the shaft portion 74 and the distal end side of the proximal end side connecting portion 90.
  • a tip end side tapered portion 92 is formed.
  • the distal end side of the annular protrusion 44a of the hub 14 is inserted into the second space 86 on the proximal end side connecting portion 90 side before and during use. That is, the peripheral wall 88 of the base end side connecting portion 90 is supported from the inside by the tip of the hub 14, and the cap 24 is attached to the outside of the tip portion 76 in this state before use.
  • the cap 24 that covers the needle body 12 in the product provision state is formed in a cylindrical shape that is long in the axial direction, and an arrangement space 25 in which the needle body 12 and the distal end portion 76 are disposed is provided therein.
  • An inner diameter on the proximal end side of the cylindrical wall 24a constituting the cap 24 is formed to be slightly smaller (or the same diameter) than an outer diameter of the proximal end side connecting portion 90 of the distal end portion 76, and the cap 24 and the distal end portion are formed. In the attached state of 76, it is in close contact with the outer peripheral surface of the proximal end side connecting portion 90.
  • the material constituting the cap 24 is not particularly limited as long as it is a material harder than the wing member 20.
  • the resin material mentioned in the hub 14 may be appropriately adopted.
  • the cap 24 of this embodiment employs polypropylene.
  • the distal end portion 76 becomes a portion that is easily elastically deformed due to the low elastic modulus, and the distal end of the hard hub 14 enters the second space 86 inside thereof.
  • the tip end side of the protector 16 is in a state where the tip end portion 76 is sandwiched between the hard hub 14 and the cap 24 before use (see also FIG. 6). Therefore, the peripheral wall 88 of the base end side connecting portion 90 moves so that the gap between the hub 14 and the cap 24 is filled, and the hub 14 and the cap 24 are closed without being bent radially outward or radially inward. Maintain state.
  • the medical needle 10 before use, has the cylindrical wall 24a of the cap 24 and the peripheral wall 88 of the proximal end side connecting portion 90 firmly adhered to each other, and the peripheral wall 88 of the proximal end side connecting portion 90 and the hub 14 are in close contact with each other.
  • the tip is also firmly attached.
  • the arrangement space 25 of the cap 24 and the second space 86 of the distal end 76 are blocked from the outside of the medical needle 10 and the first space 62 with high airtightness.
  • the cap 24 is not in contact with the distal end side tapered portion 92 of the distal end portion 76 and is in close contact with only the outer peripheral surface of the proximal end side connecting portion 90. Therefore, although the cap 24 and the wing member 20 are mounted with high airtightness, there are few portions where the cylindrical wall 24a and the peripheral wall 88 are in surface contact, and the cap 24 and the wing member 20 can be easily removed by removing the cap 24 in the axial direction. it can.
  • the medical needle 10 may have a configuration in which the cap 24 is in contact with the entire outer peripheral surface of the distal end portion 76 to improve airtightness.
  • a return portion 94 that is inclined inward from the peripheral wall 88 and formed in a mortar shape is provided, and a tip opening 76a that communicates with the second space 86 by the protruding end of the return portion 94 is provided. Is formed.
  • the distal end opening 76a is formed to have a relatively large diameter so that the needle body 12 can pass in a non-contact manner when the needle body 12 moves backward.
  • the diameter of the tip opening 76a depends on the outer diameter of the needle body 12, for example, when the clearance of 0.3 mm or more is formed between the needle body 12 and the needle body 12, the needle body 12 is not contacted. Can pass well. In the present embodiment, the diameter of the tip opening 76a is set to 2 mm. Note that the medical needle 10 does not have to include the return portion 94.
  • the medical needle 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
  • the medical needle 10 is provided as a blood collection set for use in donating whole blood.
  • the needle body 12 and the hub 14 fixed state are first sterilized by an appropriate sterilization process and then assembled to the protector 16.
  • the wing member 20 is fixed to the mounting cylinder portion 64 of the housing cylinder 18, and the hub 14 and the protector 16 are integrated with each other by engaging the arm 50 of the hub 14 and the engagement hole 70 of the housing cylinder 18. Can be handled.
  • the needle body 12 protrudes from the tip 76 of the wing member 20.
  • a cap 24 (see FIG. 3A) is attached to the outside of the needle body 12 and the distal end portion 76, and a blood bag and a tube 26 of a blood collection set are connected to the base end surface of the hub 14 before providing the product.
  • a blood collection set is configured.
  • the medical needle 10 is subjected to high-pressure steam sterilization (autoclave sterilization) in a blood collection set.
  • water (liquid) is stored in a tank of an autoclave device (not shown) and a medical needle 10 (blood collection set) is introduced.
  • a well-known thing may be applied for an autoclave apparatus.
  • the autoclave device performs cleaning and sterilization of the medical needle 10 by increasing the temperature of water (steam) to 100 ° C. or higher by increasing the pressure in the closed tank.
  • the distal end portion 76 is prevented from bending inward because the distal end portion of the hub 14 is inserted into the second space 86. Therefore, the cap 24 and the distal end portion 76 maintain a strong contact state, and block water from entering the arrangement space 25 from between the contact portions of the cap 24 and the distal end portion 76.
  • the closing wall 46 b of the hub 14 is in contact with the peripheral wall 58 of the housing cylinder 18 on the proximal end side (the locking cylinder portion 68) of the housing cylinder 18, and the medical needle 10 One space 62 is blocked. Therefore, it is possible to prevent the vapor from entering the first space 62 on the tip side of the contact portion, and to prevent water from collecting between the hub 14 and the housing cylinder 18.
  • the protruding end surface 47a of the blocking wall 46b and the inner surface 47b of the housing cylinder 18 are formed in a tapered shape and are in surface contact with each other. Therefore, even if the hub 14 and the housing cylinder 18 are each formed rigidly, the closing structure 47 can improve the closing property of the first space 62.
  • the peripheral wall 88 of the distal end portion 76 (base end side coupling portion 90) to which the cap 24 is fitted and the distal end of the hub 14 are not connected. Airtight contact. For this reason, the infiltration of the vapor into the space (the second space 86 and the arrangement space 25) on the tip side of the hub 14 is firmly blocked. Therefore, the medical needle 10 can reliably prevent water from adhering to the needle body 12 inserted directly into the blood vessel during the high-pressure steam sterilization process. Furthermore, the distal end portion 76 of the medical needle 10 can block outside air (including bacteria) from entering the arrangement space 25 even during product storage after high-pressure steam sterilization.
  • thermoplastic part it is possible to perform high-pressure steam pressure sterilization processing with a simple structure without performing precise design and material selection that are conventionally required to maintain airtightness using an O-ring or another part.
  • the hub 14 is in close contact with the entire inner peripheral surface of the distal end portion 76 and the outer peripheral surface of the distal end portion 76 before the needle body 12 is punctured. Since the cap 24 is in close contact with the entire circumference, the arrangement space 25 of the cap 24 can be hermetically closed. Therefore, the medical needle 10 can reliably prevent the invasion of steam from between the protector 16 and the cap 24 into the arrangement space 25 and can perform the high-pressure steam sterilization process well. And the medical needle 10 is highly sanitary.
  • the front end portion 76 is sandwiched between the hub 14 and the cap 24, so that the flesh portion moves elastically, and there is no gap between the hub 14 and the front end portion 76 and between the cap 24 and the front end portion 76. It can be adhered.
  • the protector 16 since the protector 16 includes the housing cylinder 18 and the wing member 20, the medical needle 10 can easily form an elastic portion on which the cap 24 is elastically attached.
  • the hub 14 and the protector 16 have the closed structure 47 on the proximal end side of the storage space 60, thereby suppressing steam from entering the storage space 60 on the distal side of the closed structure 47 during the high-pressure steam sterilization process. can do. Therefore, the hygiene of the hub 14 is also improved.
  • a medical needle 10A according to the second embodiment shown in FIGS. 7 to 9 is configured as an indwelling needle having a needle body 12, a hub 14, and a protector 16, like the medical needle 10. It differs from the medical needle 10 in that an O-ring 100 (seal member: blocking part) is provided.
  • the hub 14 of the medical needle 10A has a shaft portion 40 and an operation portion 42 before and during use.
  • a locking portion 44 is provided at the distal end side position
  • a closing portion 102 is provided at the proximal end side position.
  • the closing part 102 forms a closing structure 103 (see FIG. 8B) that airtightly closes the accommodation space 60 together with the accommodation cylinder 18 of the protector 16.
  • the blocking portion 102 is disposed between a pair of disk portions 104 and 106 that protrude radially outward from the outer peripheral surface of the shaft portion 40 and circulate in a ring shape along the circumferential direction, and the pair of disk portions 104 and 106. Including the O-ring 100 described above.
  • the pair of disk portions 104 and 106 are positioned in the vicinity of the peripheral wall 58 (inner surface) constituting the accommodation space 60 in a state where the hub 14 is accommodated in the protector 16. That is, the pair of disk portions 104 and 106 are not in contact with the peripheral wall 58.
  • the pair of disk portions 104 and 106 form a groove having an interval that can accommodate the O-ring 100 without a gap.
  • the O-ring 100 is disposed along the circumferential direction on the outer peripheral surface of the hub 14 between the pair of disk portions 104 and 106.
  • the outer portion of the O-ring 100 slightly protrudes outward in the radial direction from the outer edges of the pair of disk portions 104 and 106.
  • the O-ring 100 contacts the entire circumference of the circumferential wall 58 of the housing cylinder 18 in a state where the hub 14 is housed in the housing space 60 of the protector 16.
  • the O-ring 100 hermetically closes the accommodation space 60 on the tip side of the O-ring 100 and prevents the intrusion of fluid (steam or bacteria).
  • the material constituting the O-ring 100 is not particularly limited, but a material having an appropriate elastic force is desirable.
  • the material of the wing member 20 described above may be appropriately applied.
  • the medical needle 10A according to the second embodiment is basically configured as described above, and the operation and effect thereof will be described below. Similarly to the medical needle 10 according to the first embodiment, the medical needle 10A is assembled into a blood collection set and subjected to high-pressure steam sterilization (autoclave sterilization) in the state of the blood collection set.
  • high-pressure steam sterilization autoclave sterilization
  • the cap 24 and the tip 76 are maintained in a tight contact state, and fluid (steam or bacteria) enters the arrangement space 25 from between the contact portions of the cap 24 and the tip 76. Shut off.
  • the O-ring 100 provided in the hub 14 contacts the peripheral wall 58 of the housing cylinder 18 on the proximal end side of the first space 62, and the first space 62 on the distal end side with respect to this contact portion. Airtightly blocked. Therefore, the flow of steam and bacteria to the first space 62 on the tip side of the O-ring 100 is reliably blocked.
  • the O-ring 100 is formed relatively large in the locking cylinder portion 68 and elastically deforms, and the movement of the hub 14 in the axial direction is restricted by the pair of disk portions 104 and 106, so that the engagement cylinder 18 is engaged.
  • the tip position is blocked from the joint hole 70. Therefore, the O-ring 100 exhibits high sealing performance and reliably closes the first space 62 on the tip side of the O-ring 100.
  • the closing portion 102 is provided on the proximal end side of the hub 14, when the hub 14 is retracted in the proximal direction with respect to the protector 16, the O-ring 100 is immediately exposed to the outside. Therefore, the medical staff can perform the backward operation of the hub 14 with a weak force.
  • the O-ring 100 that comes into contact with the inner surface of the protector 16 airtightly closes the accommodation space 60 on the tip side of the contact portion. For this reason, it can prevent reliably that vapor
  • FIG. Therefore, the medical needle 10A can be well subjected to high-pressure steam sterilization, and no water adheres to the needle body 12 after the treatment, so that the hygiene of the needle body 12 can be enhanced.
  • the O-ring 100 is arranged at the proximal end side position in the accommodation space 60, so that the medical needle 10A extends to the front side of the O-ring 100 when performing the high-pressure steam sterilization process. Against this, it is possible to prevent the invasion of steam and bacteria. Therefore, the hygiene of the hub 14 is also improved.
  • the medical needle 10A is not limited to the above-described embodiment, and various modifications and application examples can be taken.
  • the sealing member that closes the accommodation space 60 is not limited to the O-ring 100, and various members that can be airtightly closed with the peripheral wall 58 may be applied.
  • a block-shaped member made of an elastic body may be provided in the middle of the hub 14, and a film material made of an elastic body may be attached to the outer peripheral surface of the hub 14.
  • some modified examples of the medical needle 10A will be described with some examples.
  • the hub 110 according to the first modification shown in FIG. 10 is different from the hub 14 according to the present embodiment in that the closing portion 112 is provided on the distal end side of the hub 110.
  • the closing portion 112 is a pair of disk portions 114 and 116 that protrude radially outward from the outer peripheral surface of the hub 110, and an O-ring disposed between the pair of disk portions 114 and 116. 118.
  • the pair of disk portions 114 and 116 protrudes short so as not to contact the peripheral wall 58 (inner surface) of the housing cylinder 18.
  • the distance between the pair of disk portions 114 and 116 is shorter than the pair of disk portions 104 and 106 of the hub 14 and accommodates an O-ring 118 that is similarly formed in a small shape.
  • the O-ring 118 When the O-ring 118 is attached to the hub 110, the O-ring 118 protrudes radially outward from the pair of disk portions 114 and 116 and comes into air-tight contact over the entire circumferential direction of the peripheral wall 58. As a result, the accommodation space 60 (that is, the second space 86 communicating with the first space 62) and the arrangement space 25 on the tip side of the O-ring 118 are closed. That is, the O-ring 118 can obtain the same effect as that of the O-ring 100 and can prevent vapor and bacteria from entering the needle body 12 in the arrangement space 25.
  • the installation position of the seal member on the axial direction of the hubs 14 and 110 is not particularly limited.
  • the hub 120 has a first closing portion 122 on the axial base end side and a second closing portion 124 on the axial front end side.
  • the first closing portion 122 includes a pair of disk portions 104 and 106 and an O-ring 100 similarly to the closing portion 102
  • the second closing portion 124 includes a pair of disk portions 114 and 116 and an O-ring similar to the closing portion 112. 118 is included. If a plurality of seal members are provided in the axial direction of the hub 120 in this way, the occlusion can be further improved and the entry of steam and bacteria during the high-pressure steam sterilization treatment can be prevented more reliably.
  • the protector 16 may be constituted by a protective member 126 in which the housing cylinder 18 and the wing member 20 are integrally formed.
  • the protective member 126 is made of a material harder than the O-rings 100 and 118, and the internal accommodation space 60 is hermetically sealed by contact of the O-rings 100 and 118.
  • an appropriate sealing means for example, an O-ring 128 shown in FIG. 11 may be provided at a place where the cap 24 and the protection member 126 are attached.
  • a medical needle 10B according to the third embodiment shown in FIGS. 12 to 14B is configured as an indwelling needle having a needle body 12, a hub 14, and a protector 16 in the same manner as the medical needle 10. It differs from the medical needle 10 in that it includes a closing member 54 (sealing member: blocking part).
  • the mounting tube portion 64 of the housing tube 18 (the protector 16) has an arrangement portion 64a for housing and arranging the closing member 54 (sealing member) on the distal end side of the first space 62. (See also FIG. 13).
  • the disposing portion 64a is formed to be thinner than the wall thickness of the peripheral wall 58 on the base end side, so that the inner surface of the first space 62 is slightly enlarged in diameter.
  • the arrangement portion 64 a regulates the displacement of the closing member 54 in the proximal direction in the accommodated state of the closing member 54.
  • the closing member 54 is housed and disposed in the placement portion 64a, and is secured to the housing cylinder 18 by an appropriate securing means such as adhesion or welding.
  • the occlusion member 54 has a function of sealing between the hub 14 and the protector 16 during high-pressure steam sterilization processing and preventing blood spillage from the needle body 12 after use.
  • the closing member 54 includes a side wall 54a that protrudes in parallel along the axial direction of the housing cylinder 18, and a distal end wall 54b that is connected to the distal end side of the side wall 54a and closes the distal end side of the closing member 54, and has a short axial direction. It is formed in a bottom cylinder shape.
  • the outer peripheral surface of the side wall 54a is fixed to the inner peripheral surface of the arrangement portion 64a.
  • An insertion space 56 that communicates with the first space 62 on the proximal end side and into which the distal end of the hub 14 can be inserted is formed inside the side wall 54a.
  • the side wall 54a that constitutes the insertion space 56 is set to have an inner diameter smaller than the inner diameter of the peripheral wall 58 of the housing cylinder 18, and protrudes from the peripheral wall 58 toward the inner side in the radial direction of the first space 62, so that it can be used before and during use.
  • Surface contact is made over the entire outer peripheral surface of the tip of the hub 14. That is, in the medical needle 10B, the inner surface of the side wall 54a and the outer surface of the distal end of the hub 14 come into airtight contact with each other, and the distal end side of the first space 62 is closed.
  • the distal end wall 54b of the closing member 54 is formed in a film shape in a direction perpendicular to the axial direction from the distal end of the side wall 54a, and a space (second space 86) on the distal end side relative to the distal end wall 54b and the insertion space 56 are formed. Cut off.
  • the tip wall 54b is formed to be thicker than the side wall 54a, so that damage and the like are suppressed, and the tip wall 54b can be easily elastically deformed.
  • the distal end of the hub 14 is in contact with the proximal end surface of the distal end wall 54b before and during use.
  • a slit 56a (through portion) capable of communicating the insertion space 56 and the second space 86 is formed at the center of the tip wall 54b.
  • the needle body 12 is arranged through the slit 56a before and during use.
  • the closing member 54 may be configured not to include the slit 56a but to pierce and penetrate the needle body 12 into the distal end wall 54b when the medical needle 10B is assembled.
  • the material constituting the closing member 54 is not particularly limited, but a material having an appropriate elastic force is desirable.
  • the material of the wing member 20 described above may be appropriately applied.
  • the medical needle 10B is basically configured as described above, and the operation and effect thereof will be described below. Similarly to the medical needles 10 and 10A, the medical needle 10B is assembled into a blood collection set, and is subjected to high-pressure steam sterilization processing (autoclave sterilization processing) in the state of the blood collection set.
  • high-pressure steam sterilization processing autoclave sterilization processing
  • the blocking member 54 provided on the tip side of the first space 62 has a tip of steam or bacteria as shown in FIG. 14A. Block direction movement.
  • the side wall 54a of the closing member 54 fixed to the peripheral wall 58 of the housing cylinder 18 and the tip of the hub 14 are in airtight contact.
  • the side wall 54 a is sandwiched between the housing cylinder 18 and the hub 14. Therefore, the side wall 54a moves so as to fill the gap on the distal end side of the first space 62, and maintains the closed state with the hub 14 without bending radially outward or radially inward. Therefore, the invasion of vapor and bacteria into the space (second space 86 and arrangement space 25) on the tip side of the closing member 54 is firmly blocked.
  • the cap 24 is removed by the medical staff, and the needle body 12 is punctured into the blood vessel of the blood donor.
  • the needle body 12 is removed from the patient's body surface by the medical staff.
  • the medical worker presses the operation projections 50b of the pair of arms 50 to release the engagement between the protector 16 and the hub 14, and the needle 14 is moved backward relative to the protector 16 by moving the hub 14 relatively back. It guides to the accommodation space 60 of the protector 16.
  • the tip opening 76a of the wing member 20 is formed to be relatively large, the puncture portion of the needle body 12 can pass through the return portion 94 in a non-contact manner and adheres to the periphery of the needle body 12.
  • the wiping of blood that is being done can be suppressed. Therefore, the hygiene of the outer surface side of the wing member 20 is maintained.
  • the front end of the hub 14 comes out of close contact with the side wall 54a and moves away from the closing member 54 with relative ease. Accordingly, as shown in FIG. 14B, the needle tip 28 of the needle body 12 moves to the proximal end side with respect to the closing member 54.
  • the closing member 54 allows the needle body 12 to retract while the distal end wall 54b is in contact with the outer peripheral surface of the needle body 12 that is disposed through the slit 56a. For this reason, when the blood has adhered around the needle body 12, the blood is wiped by the tip wall 54b. As described above, the blood wiped by the distal end wall 54b moves to the distal end side along the peripheral wall 88 when the distal end of the medical needle 10B is discarded with the distal end facing downward.
  • the medical needle 10B is provided with an annular recess 96 by the return portion 94 at the tip of the protector 16, and blood can be accumulated in the annular recess 96 to suppress blood spillage from the tip opening 76a.
  • the distal end wall 54b from which the needle body 12 is removed narrows (or closes) the slit 56a radially inward. Deform. Therefore, even if blood remains in the flow path 30 or the like of the needle body 12 and an external force or the like is applied to the medical needle 10B and the blood is separated from the needle body 12, the blood is more distal than the blocking member 54 by the distal end wall 54b. It can be prevented from flowing out to the side.
  • the medical needle 10B according to the third embodiment can obtain the same effects as the medical needles 10 and 10A by including the closing member 54 that closes the inside of the accommodation space 60 in an airtight manner.
  • the closing member 54 can reliably block steam and bacteria from moving to the arrangement space 25 on the distal end side of the hub 14 during the high-pressure steam sterilization process by making airtight contact with the outer peripheral surface of the hub 14. .
  • the medical needle 10B can retract the hub 14 relative to the side wall 54a of the closing member 54.
  • the distal end wall 54b can easily narrow or close the slit 56a, and can more reliably suppress the outflow of blood from the needle body 12 accommodated in the accommodation space 60.
  • the medical needle 10B is not limited to the above-described embodiment, and various modifications and application examples can be taken.
  • the protector 16 may be formed by integrally molding the housing cylinder 18 and the wing member 20.
  • the closing member 54 may be configured by only the tip wall 54b without including the side wall 54a. This is because if the distal end wall 54b comes into contact with the needle body 12 and closes the accommodation space 60, it is possible to prevent vapor and bacteria from entering the second space 86 and the arrangement space 25.
  • FIGS. 15A to 15C another modification of the medical needle 10B will be described with reference to FIGS. 15A to 15C.
  • the protector 16A according to the third modification shown in FIG. 15A is different from the protector 16 in that the closing member 200 has a side wall 200a and a tip wall 200b, but the tip wall 200b protrudes radially inward. That is, the closing member 200 has a non-contact through hole 202 on the outer peripheral surface of the needle body 12. Even if the closing member 200 is configured in this manner, the side wall 200a is in airtight contact with the hub 14, so that steam can be shut off during the high-pressure steam sterilization process. Further, from this point of view, the closing member 200 may have a cylindrical shape including only the side wall 200a without the tip wall 200b.
  • the closing member 210 has a structure in which the tip of the hub 14 is airtightly accommodated. Specifically, a groove portion 212 corresponding to the shape of the tip end of the hub 14 is provided on the base end surface of the closing member 210. The groove portion 212 accommodates the tip end of the hub 14 before and during use, and makes airtight contact. As a result, the closing member 210 can more reliably prevent vapor from entering the second space 86 and the arrangement space 25.
  • a protector 16C according to the fifth modification shown in FIG. 15C is different from the protectors 16, 16A, and 16B in that a closing portion 220 (sealing member) is integrally formed inside the tip portion 76 of the wing member 20A.
  • the closing part 220 closes the distal end of the housing cylinder 18 inward in the radial direction so as to penetrate the needle body 12 and make airtight contact with the outer peripheral surface of the needle body 12.
  • the distal end of the hub 14 is in contact with the proximal end surface of the closing portion 220 before and during use.
  • steam which entered into the 1st space 62 will be interrupted
  • positioning space 25 can be prevented.
  • the closing portion 220 is integrally formed with the wing member 20A, the number of parts is reduced, and the manufacturing cost and labor during manufacturing can be reduced.
  • the shape of the closing portion integrally formed with the wing members 20 and 20A is not limited to the illustrated example, and may be the same shape as the closing members 54, 200, and 210.

Abstract

A medical needle (10) is provided with a needle body (12) that is a needle body, a hub (14), a protector (16) comprising an accommodation space (60), and a cap (24). A tip section (76) that is more elastic than the hub (14) and the cap (24) at at least the mounting location of the cap (24) is provided to the protector (16). Prior to puncturing with the needle body (12), the cap (24) is held tightly on the exterior of the tip section (76) having the hub (14) arranged on the interior thereof.

Description

医療用針Medical needle
 本発明は、針体の使用前に、この針体を配置した空間の気密性及び無菌性を確保する構造を備えた医療用針に関する。 The present invention relates to a medical needle having a structure that ensures airtightness and sterility of a space in which the needle body is disposed before the needle body is used.
 献血では、専用の採血針を供血者に穿刺及び留置することで血液導出部を構築し、この血液導出部に繋がる血液バッグに血液を貯留する。使用された採血針は、感染防止のため献血終了後に廃棄される。近年では、廃棄時に採血針の針先の誤刺を防止するため、例えば特許第3198492号公報に示すように、針体を収容するプロテクタを備えた医療用針が開発及び提供されている。 In blood donation, a blood outlet is constructed by puncturing and placing a dedicated blood collection needle on a donor, and blood is stored in a blood bag connected to the blood outlet. The used blood collection needle is discarded after blood donation is completed to prevent infection. In recent years, in order to prevent a needle tip of a blood collection needle from being mistaken at the time of disposal, for example, as shown in Japanese Patent No. 3198492, a medical needle equipped with a protector that accommodates a needle body has been developed and provided.
 また、この種の医療用針は、衛生性を高めるため、製品提供前に針体、プロテクタ、及び針体を覆うキャップ等を組み付けた状態で滅菌処理が施される。例えば、全血用の採血針に対しては、高圧蒸気滅菌処理(オートクレーブ滅菌処理)が実施されている(特開平8-182741号公報参照)。 In addition, in order to improve hygiene, this type of medical needle is sterilized with a needle body, a protector, a cap that covers the needle body, and the like assembled before providing the product. For example, high-pressure steam sterilization (autoclave sterilization) is performed on blood collection needles for whole blood (see JP-A-8-182741).
 ところで、医療用針の針体は、血管内に直接挿入される部分であり、使用する前に長期保管がなされた場合でも衛生であることが求められる。そのため、医療用針は、高圧蒸気滅菌処理時に針体に水を付着させない、且つ製品保管期間において外気と接触できないように(すなわち、針体まで蒸気や外気が届かないように)、高い気密性を有する構造であることが求められている。 By the way, the needle body of a medical needle is a part that is directly inserted into a blood vessel, and is required to be hygienic even if it is stored for a long time before use. Therefore, the medical needle has high airtightness so that water does not adhere to the needle body during high-pressure steam sterilization and it cannot come into contact with the outside air during the product storage period (that is, steam or outside air does not reach the needle body). It is calculated | required that it is a structure which has.
 本発明は、上記の実情に鑑みてなされたものであって、組立状態で針体を配置した空間に連通する可能性がある部分を遮断することで、高圧蒸気滅菌処理時や高圧蒸気滅菌処理後において針体の衛生性を高めることができる医療用針を提供することを目的とする。 The present invention has been made in view of the above circumstances, and by blocking a portion that may communicate with the space in which the needle body is arranged in an assembled state, the high-pressure steam sterilization process or the high-pressure steam sterilization process It aims at providing the medical needle which can improve the hygiene of a needle body later.
 前記の目的を達成するために、本発明に係る医療用針は、針体と、前記針体を保持する針保持部と、前記針体の穿刺前の状態で、前記針保持部を収容して前記針体を先端から露出し、穿刺後に前記針保持部の基端方向の相対移動に伴い前記針体を収容する収容空間を有するプロテクタと、を備え、前記針保持部と前記プロテクタの間には、流体の流動を遮断する遮断部が設けられていることを特徴とする。 In order to achieve the above object, a medical needle according to the present invention accommodates a needle body, a needle holding section that holds the needle body, and the needle holding section in a state before puncturing the needle body. And a protector having an accommodation space for accommodating the needle body in association with relative movement in the proximal direction of the needle holding portion after puncturing, and the needle body is disposed between the needle holding portion and the protector. Is provided with a blocking portion for blocking the flow of fluid.
 上記によれば、医療用針は、針保持部とプロテクタの間に遮断部を備えることで、高圧蒸気滅菌処理時や高圧蒸気滅菌処理後に、針保持部とプロテクタの間で流体(蒸気や外気)が流動することを遮断することができる。すなわち、医療用針は、組立状態で針体を配置した空間に連通する部分が遮断されて針体を配置した空間に蒸気や外気が届くことが防止されるので、針体に対する蒸気や外気の影響がなくなり、針体の衛生性を高めることが可能となる。 According to the above, the medical needle is provided with a blocking part between the needle holding part and the protector, so that a fluid (steam or outside air) is generated between the needle holding part and the protector during the high-pressure steam sterilization process or after the high-pressure steam sterilization process. ) Can be blocked from flowing. That is, in the medical needle, the portion communicating with the space in which the needle body is arranged in the assembled state is blocked and the vapor and the outside air are prevented from reaching the space in which the needle body is arranged. There is no effect, and the hygiene of the needle body can be improved.
 この場合、前記針体の穿刺前に前記プロテクタに装着され、前記針体を覆うキャップを備え、前記プロテクタは、少なくとも前記キャップの装着箇所に弾性体からなり前記遮断部として構成される嵌合部を有し、前記針体の穿刺前の状態で、前記針保持部が前記嵌合部の内周面全周に密着すると共に、前記キャップが前記嵌合部の外周面全周に密着する構成であるとよい。 In this case, the fitting body is provided with a cap that is attached to the protector before the needle body is punctured and covers the needle body, and the protector is formed of an elastic body at least at the attachment position of the cap and is configured as the blocking portion. In the state before puncturing the needle body, the needle holding portion is in close contact with the entire inner peripheral surface of the fitting portion, and the cap is in close contact with the entire outer peripheral surface of the fitting portion It is good to be.
 このように、医療用針は、針体の穿刺前の状態で、針保持部がプロテクタの弾性体からなる嵌合部の内周面全周に密着すると共に、キャップがこの嵌合部の外周面全周に密着することで、キャップ内の針体を配置した空間を気密に閉塞することができる。従って、医療用針は、キャップの内部への流体の浸入を防いで、高圧蒸気滅菌処理を良好に実施させることができる。これにより処理後に針体に対する液体の付着がなくなり、さらに長期保管中の外気接触を完全に遮断することができる。 As described above, the medical needle is in a state before the needle body is punctured, and the needle holding portion is in close contact with the entire inner peripheral surface of the fitting portion made of the elastic body of the protector, and the cap is the outer periphery of the fitting portion. By closely adhering to the entire circumference of the surface, the space in which the needle body in the cap is arranged can be airtightly closed. Therefore, the medical needle can prevent the fluid from entering the cap and can perform the high-pressure steam sterilization process satisfactorily. As a result, the liquid does not adhere to the needle body after the treatment, and the outside air contact during long-term storage can be completely blocked.
 上記構成に加えて、前記嵌合部は、前記針体の穿刺前の状態で、前記針保持部と前記キャップの間に挟持されるとよい。 In addition to the above configuration, the fitting portion may be sandwiched between the needle holding portion and the cap in a state before the needle body is punctured.
 このように、嵌合部は、針保持部とキャップの間に挟持されることで、その肉部分が弾性的に動いて、針保持部と嵌合部及びキャップと嵌合部の間を隙間なく密着させることができる。 As described above, the fitting portion is sandwiched between the needle holding portion and the cap, so that the flesh portion moves elastically, and a gap is formed between the needle holding portion and the fitting portion and between the cap and the fitting portion. It can be closely attached.
 この場合、前記プロテクタは、前記針体の収容状態で、該針体の先端まで囲う硬質な収容筒と、前記収容筒に装着され、前記収容筒よりも先端方向に突出した前記嵌合部を有する弾性部材と、を備えることが好ましい。 In this case, the protector includes the rigid housing cylinder that surrounds the tip of the needle body in the housing state of the needle body, and the fitting portion that is attached to the housing cylinder and protrudes in the distal direction from the housing cylinder. It is preferable to provide an elastic member.
 このように、プロテクタが収容筒と弾性部材を備えることで、医療用針は、キャップの装着箇所に嵌合部を簡単に設けることができる。 Thus, by providing the protector with the housing cylinder and the elastic member, the medical needle can easily provide the fitting portion at the mounting position of the cap.
 さらに、前記弾性部材は、前記収容筒に装着される軸部と、前記軸部から幅方向外側に突出するウイングとを有する翼部材に構成され、前記嵌合部は、前記軸部に一体成形されていることが好ましい。 Further, the elastic member is configured as a wing member having a shaft portion attached to the housing cylinder and a wing protruding outward in the width direction from the shaft portion, and the fitting portion is integrally formed with the shaft portion. It is preferable that
 このように、嵌合部と軸部が一体成形されていることで、嵌合部は、翼部材の成形に伴い容易に構成される。また医療用針は、部品点数が少なくなって、気密性を高めつつも、組付時の作業効率が向上、及び製造コストの低減を図ることができる。 Thus, since the fitting portion and the shaft portion are integrally formed, the fitting portion is easily configured as the wing member is formed. In addition, the medical needle has a reduced number of parts and can improve airtightness while improving work efficiency during assembly and reducing manufacturing costs.
 また、前記プロテクタの前記収容空間を構成する内面と前記針保持部の外面とは、前記針体の穿刺前の状態で、前記収容空間の基端側で互いに接触することにより、前記収容空間の先端側への流体の流入を抑制する閉塞構造を形成していることが好ましい。 In addition, the inner surface of the protector and the outer surface of the needle holding portion are in contact with each other on the proximal end side of the storage space before the needle body is punctured, thereby It is preferable to form a blocking structure that suppresses the inflow of fluid to the distal end side.
 このように、針保持部とプロテクタは、収容空間の基端側に閉塞構造を有することで、高圧蒸気滅菌処理を行う際に、閉塞構造よりも先端側の収容空間への蒸気の浸入を抑制することができる。よって、針保持部の衛生性も高められる。 In this way, the needle holding part and the protector have a closed structure on the proximal end side of the storage space, so that when high-pressure steam sterilization is performed, entry of steam into the storage space on the distal end side than the closed structure is suppressed. can do. Therefore, the hygiene of the needle holder is also improved.
 また、前記閉塞構造は、前記針保持部の外面から突出する閉塞壁のテーパ状の突出端面と、前記プロテクタのテーパ状の内面とが接触することで構成されるとよい。 Further, it is preferable that the closing structure is configured such that a tapered protruding end surface of the closing wall protruding from the outer surface of the needle holding portion comes into contact with a tapered inner surface of the protector.
 このように、針保持部の突出端面とプロテクタの内面がテーパ状に接触することで、閉塞構造を簡単に形成すると共に、針保持部の基端方向の相対移動を容易に行うことができる。 As described above, the protruding end surface of the needle holding portion and the inner surface of the protector are brought into contact with each other in a tapered shape, whereby a closed structure can be easily formed and the needle holding portion can be easily moved in the proximal direction.
 或いは、前記針保持部の外周面には、前記針体の穿刺前の状態で、前記遮断部として構成されて前記プロテクタの内周面の全周にわたって接触する弾性体からなるシール部材が設けられてもよい。 Alternatively, the outer peripheral surface of the needle holding portion is provided with a sealing member made of an elastic body configured as the blocking portion and in contact with the entire circumference of the inner peripheral surface of the protector before the needle body is punctured. May be.
 このように、針保持部に設けられたシール部材がプロテクタの内周面の全周にわたって接触することで、シール部材は、プロテクタとの接触部分よりも先端側の収容空間を気密に閉塞する。従って、医療用針は、高圧蒸気滅菌処理時や高圧蒸気滅菌処理後における針体の衛生性をより高めることができる。 In this way, the seal member provided in the needle holding portion contacts the entire circumference of the inner peripheral surface of the protector, so that the seal member airtightly closes the accommodation space on the tip side with respect to the contact portion with the protector. Therefore, the medical needle can further improve the hygiene of the needle body during the high-pressure steam sterilization process or after the high-pressure steam sterilization process.
 この場合、前記シール部材は、前記針体の穿刺前の状態で、前記収容空間内の基端側位置に配置されることが好ましい。 In this case, it is preferable that the seal member is disposed at a proximal end position in the accommodation space in a state before the needle body is punctured.
 このように、シール部材が収容空間内の基端側位置に配置されることで、医療用針は、高圧蒸気滅菌処理を行う際に、シール部材より先端側で針保持部が延在する空間に対しても流体の浸入を防止することができる。また、シール部材は、針体の基端方向の相対移動時に収容空間から直ぐに抜けて、針保持部の後退を容易化することができる。 Thus, when the seal member is arranged at the proximal end position in the accommodation space, the medical needle is a space in which the needle holding portion extends on the distal end side from the seal member when performing the high-pressure steam sterilization process. In contrast, the intrusion of fluid can be prevented. Further, the seal member can be easily removed from the accommodation space during the relative movement of the needle body in the proximal direction, thereby facilitating the retraction of the needle holding portion.
 また、前記プロテクタは、該プロテクタの先端部よりも径方向外側に拡径した基端拡径部を有し、前記シール部材は、前記針体の穿刺前の状態で、前記基端拡径部の内側に配置されるとよい。 In addition, the protector has a proximal end diameter-enlarged portion that is expanded radially outward from the distal end portion of the protector, and the seal member is in the state before the needle body is punctured, It is good to arrange inside.
 このように、シール部材をプロテクタの基端拡径部の内側に配置することにより、収容空間の基端側が広くなるので、比較的大きなシール部材を適用することができる。このためシール部材は、針保持部に対する組み付けが容易となり、またプロテクタの内周面への密着力が高まる。 Thus, by disposing the seal member inside the base end enlarged diameter portion of the protector, the base end side of the accommodation space is widened, so that a relatively large seal member can be applied. For this reason, the seal member can be easily assembled to the needle holding portion, and the adhesion to the inner peripheral surface of the protector is increased.
 さらに、前記シール部材は、前記針体の穿刺前の状態で、前記収容空間内の先端側位置に配置されてもよい。 Furthermore, the seal member may be disposed at a distal end side position in the accommodation space in a state before the needle body is punctured.
 このように、シール部材が収容空間内の先端側位置に配置されても、シール部材は針体が配置される空間を気密に遮断することができるので、高圧蒸気滅菌処理において針体に液体が付着することを回避することができる。 Thus, even when the seal member is disposed at the distal end side position in the accommodation space, the seal member can airtightly block the space in which the needle body is disposed. Adhesion can be avoided.
 或いは、前記プロテクタは、前記収容空間を構成する収容筒を備え、前記収容筒内には、前記針体の穿刺前の状態で、前記遮断部として構成されて前記針保持部に接すると共に、当該収容筒の内周面を全周にわたって封止する弾性体からなる封止部材が設けられてもよい。 Alternatively, the protector includes a storage cylinder that constitutes the storage space, and the protection cylinder is configured as the blocking section in contact with the needle holding section in a state before the needle body is punctured. A sealing member made of an elastic body that seals the inner peripheral surface of the housing cylinder over the entire circumference may be provided.
 このように、医療用針は、プロテクタの収容筒の内周面を全周にわたって封止部材が封止することで、収容空間の先端側に連通する可能性がある針体を配置した空間に、流体が浸入するのを確実に防ぐことができる。 As described above, the medical needle is sealed in the space in which the needle body that may communicate with the distal end side of the housing space is arranged by sealing the inner peripheral surface of the housing cylinder of the protector over the entire circumference. , It is possible to reliably prevent the fluid from entering.
 この場合、前記封止部材は、前記収容筒の内周面において、前記針体の穿刺前の状態で、該針体を貫通させ、前記針体の穿刺後の状態で、該針体を前記封止部材より基端側の前記収容空間内に配置させるとよい。 In this case, the sealing member penetrates the needle body on the inner peripheral surface of the housing cylinder before the needle body is punctured, and the needle body is inserted into the needle body after the needle body is punctured. It is good to arrange | position in the said accommodation space of a base end side from the sealing member.
 このように、医療用針は、針体の穿刺後に、封止部材よりも基端側の収容空間に針体を配置させることで、収容後に針体に付着した血液の飛散を抑えて、血液汚染等の不都合を抑止することができる。 As described above, the medical needle is disposed in the accommodation space closer to the base end side than the sealing member after the needle body is punctured, thereby suppressing the scattering of blood adhering to the needle body after the accommodation. Inconveniences such as contamination can be suppressed.
 また、前記封止部材は、前記針体の穿刺前の状態で、前記針体の外周面に接触し、さらに、前記収容空間に前記針体を収容した状態で、前記針体の貫通していた部分が内側に狭まる又は閉塞するとよい。 Further, the sealing member is in contact with the outer peripheral surface of the needle body before the needle body is punctured, and further penetrates the needle body in a state where the needle body is accommodated in the accommodation space. It is preferable that the portion is narrowed or closed inside.
 このように、封止部材が、収容空間に針体を収容した状態で、針体の貫通していた部分が内側に狭まる又は閉塞することで、医療用針は、封止部材よりも先端側への血液の流出を防止することができ、穿刺後の衛生性がより向上する。 Thus, the medical needle is more distal than the sealing member when the sealing member accommodates the needle body in the accommodation space and the portion through which the needle body penetrates narrows or closes inward. The blood can be prevented from flowing out into the body, and the hygiene after puncture is further improved.
 さらに、前記プロテクタは、前記封止部材の配置位置よりも先端側に前記針体から離れた血液を溜めるための血液溜まり部を有する構成であってもよい。 Further, the protector may have a blood reservoir part for storing blood away from the needle body on the tip side of the arrangement position of the sealing member.
 このように、プロテクタが血液溜まり部を有することで、医療用針は、封止部材が針体の後退時に針体の血液を拭った場合に、封止部材の先端方向に血液が流れても血液溜まり部によって血液の流出を防ぐことができる。 In this way, the protector has a blood reservoir, so that when the sealing member wipes the blood of the needle body when the sealing member is retracted, the blood flows in the distal direction of the sealing member. The blood pool can prevent blood from flowing out.
 またさらに、前記封止部材は、前記針体の穿刺前の状態で、前記針保持部の外周面全周にわたって接触していることが好ましい。 Furthermore, it is preferable that the sealing member is in contact with the entire outer peripheral surface of the needle holding portion in a state before the needle body is punctured.
 このように、封止部材は、針保持部の外周面全周にわたって接触することで、針保持部とプロテクタの間に挟まれて、隙間を埋めるように肉部分が動くことになる。そのため、高圧蒸気滅菌処理時に針保持部の先端よりも先端側の収容空間に、流体が向かうことを確実に遮断することができる。 As described above, the sealing member comes into contact with the entire outer peripheral surface of the needle holding portion, so that the meat portion moves between the needle holding portion and the protector so as to fill the gap. Therefore, it is possible to reliably block the fluid from heading toward the storage space on the tip side of the tip of the needle holder during the high-pressure steam sterilization process.
 そして、前記封止部材は、前記収容筒とは別部材からなることが好ましい。 And it is preferable that the said sealing member consists of a member different from the said storage cylinder.
 このように、医療用針は、封止部材が収容筒と別部材からなることで、プロテクタの所望の位置に封止部材を簡単に設けることができ、製造時の手間や製造コストを低減することができる。 As described above, the medical needle can be easily provided at a desired position of the protector because the sealing member is made of a separate member from the housing cylinder, and the labor and manufacturing cost during manufacturing can be reduced. be able to.
 さらにまた、前記プロテクタの先端部には、該先端部の外周面全周にわたって前記針体を覆うキャップが密着されるとよい。 Furthermore, a cap that covers the needle body may be in close contact with the tip of the protector over the entire outer peripheral surface of the tip.
 このように、プロテクタの先端部の外周面全周にわたってキャップが装着されることで、流体がキャップとプロテクタの隙間から入ることを遮断することができる。 In this way, by attaching the cap over the entire outer peripheral surface of the tip of the protector, fluid can be blocked from entering through the gap between the cap and the protector.
 本発明の医療用針によれば、組立状態で針体を配置した空間に連通する可能性がある部分を遮断することで、高圧蒸気滅菌処理時や高圧蒸気滅菌処理後において針体の衛生性を高めることができる。 According to the medical needle of the present invention, the hygienic properties of the needle body at the time of high-pressure steam sterilization treatment or after high-pressure steam sterilization treatment by blocking a portion that may communicate with the space where the needle body is arranged in the assembled state. Can be increased.
本発明の第1実施形態に係る使用時の医療用針を示す斜視図である。It is a perspective view which shows the medical needle at the time of use which concerns on 1st Embodiment of this invention. 図1の医療用針の分解斜視図である。It is a disassembled perspective view of the medical needle of FIG. 図3Aは、使用前の医療用針を示す斜視図であり、図3Bは、使用時の医療用針を示す斜視図であり、図3Cは、使用後の医療用針を示す斜視図である。3A is a perspective view showing a medical needle before use, FIG. 3B is a perspective view showing a medical needle during use, and FIG. 3C is a perspective view showing a medical needle after use. . 図4Aは、使用時の医療用針の部分平面断面図であり、図4Bは、図4AのIVB-IVB線断面図である。4A is a partial plan sectional view of the medical needle in use, and FIG. 4B is a sectional view taken along line IVB-IVB in FIG. 4A. 図5Aは、使用後の医療用針の平面図であり、図5Bは、図5AのVB-VB線断面図である。5A is a plan view of the medical needle after use, and FIG. 5B is a cross-sectional view taken along line VB-VB of FIG. 5A. 図1の医療用針の作用効果を説明する断面図である。It is sectional drawing explaining the effect of the medical needle of FIG. 本発明の第2実施形態に係る医療用針の分解斜視図である。It is a disassembled perspective view of the medical needle which concerns on 2nd Embodiment of this invention. 図8Aは、図7の医療用針の部分平面断面図であり、図8Bは、図8AのVIIIB-VIIIB線断面図である。8A is a partial plan sectional view of the medical needle of FIG. 7, and FIG. 8B is a sectional view taken along line VIIIB-VIIIB of FIG. 8A. 図7の医療用針の作用効果を説明する断面図である。It is sectional drawing explaining the effect of the medical needle of FIG. 第1変形例に係る医療用針を示す断面図である。It is sectional drawing which shows the medical needle which concerns on a 1st modification. 第2変形例に係る医療用針を示す断面図である。It is sectional drawing which shows the medical needle which concerns on a 2nd modification. 本発明の第3実施形態に係る医療用針の分解斜視図である。It is a disassembled perspective view of the medical needle which concerns on 3rd Embodiment of this invention. 図12の医療用針の側面断面図である。It is side surface sectional drawing of the medical needle of FIG. 図14Aは、図12の医療用針の高圧蒸気滅菌処理時の作用効果を説明する断面図であり、図14Bは、図12の医療用針の穿刺後の作用効果を説明する断面図である。14A is a cross-sectional view for explaining the action and effect of the medical needle of FIG. 12 during high-pressure steam sterilization, and FIG. 14B is a cross-sectional view for explaining the action and effect of the medical needle of FIG. 12 after puncturing. . 図15Aは、第3変形例に係るプロテクタを示す部分断面図であり、図15Bは、第4変形例に係るプロテクタを示す部分断面図であり、図15Cは、第5変形例に係るプロテクタを示す部分断面図である。15A is a partial cross-sectional view showing a protector according to a third modification, FIG. 15B is a partial cross-sectional view showing a protector according to a fourth modification, and FIG. 15C shows a protector according to a fifth modification. It is a fragmentary sectional view shown.
 以下、本発明に係る医療用針について好適な実施形態をあげ、添付の図面を参照して詳細に説明する。 Hereinafter, preferred embodiments of the medical needle according to the present invention will be described and described in detail with reference to the accompanying drawings.
〔第1実施形態〕
 本発明の第1実施形態に係る医療用針10は、献血に使用され、供血者の全ての血液成分を一定量採取する全血用の採血針として構成されている。図1及び図2に示すように、この医療用針10は、針体12(カヌラ)と、針体12を保持するハブ14(針保持部)と、供血者に穿刺した針体12を収容するプロテクタ16とを有する。なお、本実施形態に係る医療用針10の構成は、全血用の採血針に限定されず、成分採血用の採血針に適用してもよく、また薬液注入用の針等に適用してもよい。
[First Embodiment]
The medical needle 10 according to the first embodiment of the present invention is used for blood donation, and is configured as a blood collection needle for whole blood that collects a certain amount of all blood components of a blood donor. As shown in FIGS. 1 and 2, the medical needle 10 accommodates a needle body 12 (canula), a hub 14 (needle holding portion) for holding the needle body 12, and a needle body 12 punctured by a blood donor. Protector 16. Note that the configuration of the medical needle 10 according to the present embodiment is not limited to the whole blood blood collection needle, but may be applied to a component blood collection needle, and may be applied to a drug injection needle or the like. Also good.
 また、医療用針10は、翼付き留置針(所謂、翼状針)として構成されている。医療用針10の一対のウイング22は、医師や看護師等の医療従事者が把持して針体12の穿刺操作を行う把持部になると共に、採血中に供血者の体表に拡げられテープや包帯による固定時に使用される固定部となる。医療用針10のプロテクタ16は、収容筒18と、収容筒18に取り付けられる翼部材20(弾性部材)の軸部74とで構成され、上記のウイング22は、この軸部74に一体成形されている。なお、本実施形態に係る医療用針10の構成は、翼付き以外の針に適用することも可能である。 The medical needle 10 is configured as a winged indwelling needle (so-called winged needle). The pair of wings 22 of the medical needle 10 serves as a gripping part that is held by a medical worker such as a doctor or a nurse and performs a puncturing operation of the needle body 12, and is spread on the body surface of the blood donor during blood collection. It becomes a fixing part used when fixing with a bandage. The protector 16 of the medical needle 10 includes an accommodation cylinder 18 and a shaft portion 74 of a wing member 20 (elastic member) attached to the accommodation tube 18, and the wing 22 is integrally formed with the shaft portion 74. ing. The configuration of the medical needle 10 according to the present embodiment can also be applied to needles other than those with wings.
 医療用針10は、図3Aに示す製品提供状態(以下、使用前ともいう)で採血セットの一部品となっている。具体的には、ハブ14及びプロテクタ16を相互に組み付けた状態で、図示しない血液バッグに接続するチューブ26がハブ14の基端に連結固定されている。また医療用針10は、プロテクタ16の先端から針体12が突出し、この針体12をキャップ24で覆った状態となっている。 The medical needle 10 is a part of a blood collection set in the product provision state shown in FIG. 3A (hereinafter also referred to as “before use”). Specifically, in a state where the hub 14 and the protector 16 are assembled to each other, a tube 26 connected to a blood bag (not shown) is connected and fixed to the proximal end of the hub 14. In the medical needle 10, the needle body 12 protrudes from the tip of the protector 16, and the needle body 12 is covered with a cap 24.
 採血を行う際(以下、使用時ともいう)には、図3Bに示すように、医療従事者によりキャップ24が取り外され、露出した針体12が供血者の血管に穿刺される。これにより医療用針10は、供血者の血液を採取する血液導出部となり、チューブ26の内腔27に血液が流出して、さらに内腔27を通して血液バッグに血液が供給される。 When blood is collected (hereinafter also referred to as in use), as shown in FIG. 3B, the medical staff removes the cap 24, and the exposed needle body 12 is punctured into the blood vessel of the blood donor. As a result, the medical needle 10 becomes a blood lead-out portion that collects the blood of the blood donor, blood flows out into the lumen 27 of the tube 26, and further, blood is supplied to the blood bag through the lumen 27.
 そして、採血終了後(以下、使用後ともいう)には、医療従事者により、針体12が供血者から引き抜かれ、さらに図3Cに示すように、プロテクタ16内に針体12が収容されて廃棄される。以下、この動作を行う医療用針10の各構成について詳細に説明する。 After blood collection is finished (hereinafter also referred to as “after use”), the medical staff pulls out the needle body 12 from the blood donor, and the needle body 12 is housed in the protector 16 as shown in FIG. 3C. Discarded. Hereinafter, each configuration of the medical needle 10 that performs this operation will be described in detail.
 医療用針10の針体12は、図1、図4A及び図4Bに示すように、供血者の皮膚から血管内まで穿刺可能な剛性を有する長尺な中空管を呈している。針体12の先端には、鋭利な針先28が形成され、この針先28には血液が流入可能な開口28aが設けられる。また、針体12の内部には、開口28aに連通し、針体12の軸方向に沿って血液が流動する流動路30が設けられる。 As shown in FIGS. 1, 4A, and 4B, the needle body 12 of the medical needle 10 has a long hollow tube having rigidity that can be punctured from the skin of the blood donor to the inside of the blood vessel. A sharp needle tip 28 is formed at the tip of the needle body 12, and the needle tip 28 is provided with an opening 28a through which blood can flow. Further, inside the needle body 12, a flow path 30 is provided which communicates with the opening 28 a and allows blood to flow along the axial direction of the needle body 12.
 針体12の太さは、特に限定されないが、献血時間の短時間化や供血者の恐怖心の低減等が勘案されて設計されるとよい。本実施形態では、針体12の外径を1.25mmに設定している。また、針体12の長さも、操作性の向上や患者の恐怖心の低減等が勘案されて設計されるとよく、例えば、ハブ14から突出する部分の長さが40mm以下であると好適である。針体12の構成材料としては、例えば、ステンレス鋼、アルミニウム又はアルミニウム合金、チタン又はチタン合金のような金属材料があげられる。 The thickness of the needle body 12 is not particularly limited, but may be designed in consideration of shortening the blood donation time and reducing the fear of the donor. In the present embodiment, the outer diameter of the needle body 12 is set to 1.25 mm. Further, the length of the needle body 12 may be designed in consideration of improvement in operability and reduction in fear of the patient. For example, the length of the portion protruding from the hub 14 is preferably 40 mm or less. is there. Examples of the constituent material of the needle body 12 include a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy.
 針体12を保持するハブ14は、図2、図4A及び図4Bに示すように、針体12の軸心と同軸の軸心を有する筒状に形成され、針体12の基端部を連結固定している。このハブ14は、使用前及び使用時にプロテクタ16に係合して一体的に取扱可能となる一方で、使用後に係合を解除しプロテクタ16に対し相対的に後退することで、針体12をプロテクタ16内に配置する。 As shown in FIGS. 2, 4A and 4B, the hub 14 holding the needle body 12 is formed in a cylindrical shape having an axis coaxial with the axis of the needle body 12, and the base end portion of the needle body 12 is formed. It is connected and fixed. The hub 14 engages with the protector 16 before and during use so that the hub 14 can be handled integrally. On the other hand, the hub 14 is disengaged and retracted relative to the protector 16 after use, so that the needle body 12 is retracted. It arrange | positions in the protector 16. FIG.
 ハブ14の内部には、ハブ14の両端の開口部14a、14bに連なると共に、軸心を通る中空部32が設けられている。中空部32の先端側には、ハブ14の内壁によって、前端側の開口部14aから基端方向に向かって小径となるテーパ部34が形成されている。テーパ部34内は、接着剤36が注入されることで針体12を強固に固着している。また、テーパ部34よりも基端側の中空部32は、若干大径に形成され、固着された針体12の流動路30に連通する連通路38となっている。 Inside the hub 14, there are provided hollow portions 32 that continue to the openings 14 a and 14 b at both ends of the hub 14 and pass through the shaft center. On the distal end side of the hollow portion 32, a tapered portion 34 having a small diameter in the proximal direction from the opening portion 14 a on the front end side is formed by the inner wall of the hub 14. Inside the tapered portion 34, the needle body 12 is firmly fixed by being injected with the adhesive 36. Further, the hollow portion 32 on the proximal end side with respect to the tapered portion 34 is formed to have a slightly larger diameter, and serves as a communication passage 38 that communicates with the flow passage 30 of the needle body 12 that is fixed.
 また、ハブ14は、使用前及び使用時に、プロテクタ16内に収容されるシャフト部40と、シャフト部40の基端側に連なりプロテクタ16の外部に露出される操作部42とを一体成形して構成される。シャフト部40は、プロテクタ16内に摺動自在に配置され、プロテクタ16の軸方向長さよりも多少長い全長を有する。シャフト部40の外周面には、先端側位置に係止部44が設けられると共に、基端側位置に閉塞部46が設けられる。 Further, the hub 14 is formed by integrally forming a shaft portion 40 accommodated in the protector 16 and an operation portion 42 that is connected to the proximal end side of the shaft portion 40 and exposed to the outside of the protector 16 before and during use. Composed. The shaft portion 40 is slidably disposed in the protector 16 and has an overall length that is slightly longer than the axial length of the protector 16. On the outer peripheral surface of the shaft portion 40, a locking portion 44 is provided at the distal end side position, and a closing portion 46 is provided at the proximal end side position.
 係止部44は、先端側で径方向外側に突出する環状突起44aと、環状突起44aから基端方向に間隔をあけた位置で径方向外側に突出する環状フック部44bとを含む。環状突起44aは、断面視(図4B参照)で四角形状に形成され、環状フック部44bは、断面視で基端側に傾斜を有する略直角三角形状に形成されている。 The locking portion 44 includes an annular protrusion 44a that protrudes radially outward on the distal end side, and an annular hook portion 44b that protrudes radially outward at a position spaced from the annular protrusion 44a in the proximal direction. The annular protrusion 44a is formed in a quadrangular shape in a sectional view (see FIG. 4B), and the annular hook portion 44b is formed in a substantially right triangle shape having an inclination on the base end side in the sectional view.
 閉塞部46は、シャフト部40の外周面上で、ハブ14の基端方向に向かって徐々に大径になる円錐状に形成されている。閉塞部46は、シャフト部40の周方向に沿って複数(4つ)の切り欠き部46aを有する。切り欠き部46aは、円錐状を呈する先端から閉塞部46の基端手前まで延び、シャフト部40の外周面を露出させている。切り欠き部46aよりも基端側は、シャフト部40の周方向全周にわたって連続した円板状の閉塞壁46bを構成している。閉塞壁46bは、ハブ14から径方向外側に突出したテーパ状の突出端面47aを有する。この突出端面47aは、プロテクタ16内にハブ14を収容した状態で、収容空間60を構成する周壁58のテーパ状の内面47bに接触する。 The closing portion 46 is formed on the outer peripheral surface of the shaft portion 40 in a conical shape that gradually increases in diameter toward the base end direction of the hub 14. The blocking part 46 has a plurality of (four) cutout parts 46 a along the circumferential direction of the shaft part 40. The notch 46a extends from the tip having a conical shape to the front of the base end of the closing portion 46, and the outer peripheral surface of the shaft portion 40 is exposed. A proximal end side of the cutout portion 46a constitutes a disc-shaped blocking wall 46b that is continuous over the entire circumference of the shaft portion 40 in the circumferential direction. The blocking wall 46 b has a tapered protruding end surface 47 a that protrudes radially outward from the hub 14. The projecting end surface 47 a contacts the tapered inner surface 47 b of the peripheral wall 58 constituting the housing space 60 in a state where the hub 14 is housed in the protector 16.
 一方、操作部42は、シャフト部40に連結し、平面視(図4A参照)で、先端側が幅狭で基端側が幅広に形成された基部48と、基部48の基端側から先端方向に突出する一対のアーム50とを有する。基部48の基端面には、軸心位置に中空部32に連通する基端の開口部14bと、開口部14bの径方向外側の周囲を周回する環状の接続溝52とが設けられている。接続溝52は、チューブ26(図3A参照)を嵌合保持して、ハブ14の連通路38とチューブ26の内腔27とを連通させる。なお、基部48は、図示例のようにハブ14と一体成形されていてもよく、また別体に構成されてもよい。 On the other hand, the operation part 42 is connected to the shaft part 40, and in a plan view (see FIG. 4A), a base part 48 having a narrow front end side and a wide base end side, and a base end side of the base part 48 in the front end direction. And a pair of protruding arms 50. The base end surface of the base portion 48 is provided with a base end opening portion 14b communicating with the hollow portion 32 at an axial center position and an annular connection groove 52 that circulates around the radially outer side of the opening portion 14b. The connection groove 52 fits and holds the tube 26 (see FIG. 3A), and allows the communication path 38 of the hub 14 and the lumen 27 of the tube 26 to communicate with each other. The base 48 may be integrally formed with the hub 14 as shown in the drawing, or may be configured separately.
 アーム50は、先端側で幅方向外側に突出する爪部50aと、爪部50aから間隔をあけた基端側で幅方向外側に突出する操作突起50bとを有する。爪部50aは、使用前及び使用時において、プロテクタ16内に挿入されてプロテクタ16の係合孔70に係合する。これによりハブ14とプロテクタ16が一体化する。 The arm 50 includes a claw portion 50a that protrudes outward in the width direction on the distal end side, and an operation protrusion 50b that protrudes outward in the width direction on the base end side spaced from the claw portion 50a. The claw portion 50 a is inserted into the protector 16 and engages with the engagement hole 70 of the protector 16 before and during use. Thereby, the hub 14 and the protector 16 are integrated.
 操作突起50bは、プロテクタ16から露出されて医療従事者により押圧操作がなされる部位である。すなわち、一対のアーム50は、医療従事者による一対の操作突起50bの押圧によって内側に弾性変形する。このため、先端側の爪部50aが相互に近接してプロテクタ16との係合を解除することになり、ハブ14が針体12と共に、プロテクタ16に対し相対的に後退可能となる。 The operation protrusion 50b is a part that is exposed from the protector 16 and pressed by a medical worker. That is, the pair of arms 50 is elastically deformed inward by pressing of the pair of operation protrusions 50b by a medical worker. For this reason, the claw portions 50a on the distal end side come close to each other and release the engagement with the protector 16, so that the hub 14 together with the needle body 12 can be retracted relative to the protector 16.
 ハブ14は、比較的硬い樹脂材料により構成されることが好ましく、例えば、ポリプロピレン、ポリカーボネート、ポリアミド、ポリサルホン、ポリアリレート等の熱可塑性樹脂及びポリ塩化ビニルを好適に用いることができる。本実施形態のハブ14は、耐熱性、衛生性及び撥水性が高い材料であるポリカーボネートを採用している。 The hub 14 is preferably made of a relatively hard resin material. For example, thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and polyvinyl chloride can be suitably used. The hub 14 of this embodiment employs polycarbonate, which is a material having high heat resistance, hygiene, and water repellency.
 図2及び図3Cに示すように、医療用針10のプロテクタ16は、採血の終了後(使用後)に針体12を収容して針先28の誤刺を防止する機能を有する。プロテクタ16の収容筒18は、円筒状の周壁58により形成され、針体12の収容空間60の一部である第1空間62を内部に有する。収容筒18の軸方向長さは、針体12の収容に伴い第1空間62内に針先28を位置させるように、針体12のハブ14から突出した部分の軸方向長さよりも長く形成されている(図5Bも参照)。収容筒18の構成材料は、上記のハブ14であげた樹脂材料を適宜採用するとよい。本実施形態の収容筒18は、ハブ14と同様にポリカーボネートを採用している。 As shown in FIGS. 2 and 3C, the protector 16 of the medical needle 10 has a function of accommodating the needle body 12 after blood collection is finished (after use) and preventing the needle tip 28 from being pierced. The housing cylinder 18 of the protector 16 is formed by a cylindrical peripheral wall 58 and has a first space 62 inside which is a part of the housing space 60 of the needle body 12. The axial length of the storage cylinder 18 is longer than the axial length of the portion of the needle body 12 protruding from the hub 14 so that the needle tip 28 is positioned in the first space 62 as the needle body 12 is received. (See also FIG. 5B). As a constituent material of the housing cylinder 18, the resin material raised in the hub 14 may be appropriately adopted. The housing cylinder 18 of this embodiment employs polycarbonate in the same manner as the hub 14.
 図2に示すように、収容筒18は、翼部材20を取り付けるための取付筒部64と、取付筒部64の基端に連なり基端方向に延在する延在筒部66と、延在筒部66の基端に連なり径方向外側に多少大径に形成された係止筒部68とを有する。 As shown in FIG. 2, the storage cylinder 18 includes an attachment cylinder part 64 for attaching the wing member 20, an extension cylinder part 66 that extends to the proximal end of the attachment cylinder part 64 and extends in the proximal direction. It has a locking cylinder part 68 which is connected to the base end of the cylinder part 66 and formed on the radially outer side with a slightly larger diameter.
 取付筒部64は、延在筒部66よりも若干細く形成され、その外周面に翼部材20が密着固定される。取付筒部64と延在筒部66の段差は、翼部材20の取付位置を規定する。取付筒部64の先端側は、第1空間62にハブ14を収容した状態で、環状突起44a及び環状フック部44bを周壁58の近傍位置に位置させることで、ハブ14と収容筒18の軸心の同軸性を確保し、針体12の姿勢を安定化させる。 The attachment cylinder part 64 is formed to be slightly thinner than the extension cylinder part 66, and the wing member 20 is tightly fixed to the outer peripheral surface thereof. The level difference between the attachment cylinder part 64 and the extension cylinder part 66 defines the attachment position of the wing member 20. The distal end side of the mounting cylinder portion 64 is positioned in the vicinity of the peripheral wall 58 with the annular protrusion 44a and the annular hook portion 44b in a state where the hub 14 is accommodated in the first space 62. The coaxiality of the heart is ensured and the posture of the needle body 12 is stabilized.
 一方、係止筒部68は、延在筒部66の境界部から基端方向に向かってテーパ状に大径となり、途中位置から同径の外径で基端に至るように形成される。この係止筒部68の周壁58には、ハブ14の爪部50aを引っ掛けるため、一対の係合孔70が形成されている。なお、プロテクタ16とハブ14の係止構成は、特に限定されず、例えば、爪部50aを引っ掛け可能な凹部や溝部を周壁58に設けてもよい。 On the other hand, the locking cylinder portion 68 is formed so as to taper from the boundary portion of the extending cylinder portion 66 toward the proximal end, and to reach the proximal end from the middle position with the same outer diameter. A pair of engagement holes 70 are formed in the peripheral wall 58 of the locking cylinder portion 68 to hook the claw portion 50a of the hub 14. In addition, the latching structure of the protector 16 and the hub 14 is not specifically limited, For example, you may provide the surrounding wall 58 with the recessed part and groove part which can hook the nail | claw part 50a.
 係止筒部68のテーパ状の内面47bには、図4Bに示すように、ハブ14の閉塞壁46bの傾斜した突出端面47aが周方向全周にわたって面接触する。すなわち、ハブ14の突出端面47aと収容筒18の内面47bとは、閉塞壁46bよりも先端側の収容空間60を閉塞する閉塞構造47を構成する。 As shown in FIG. 4B, the inclined projecting end surface 47a of the blocking wall 46b of the hub 14 is in surface contact with the tapered inner surface 47b of the locking cylinder portion 68 over the entire circumference in the circumferential direction. That is, the projecting end surface 47a of the hub 14 and the inner surface 47b of the housing cylinder 18 constitute a closing structure 47 that closes the housing space 60 on the tip side of the closing wall 46b.
 また、収容筒18は、延在筒部66と係止筒部68の内側の境界部に、第1空間62の基端方向且つ軸心側に突出する複数(本実施形態では4つ)の弾性片72を有する。4つの弾性片72は、プロテクタ16の周方向に沿って等間隔に(90°位相がずれて)設けられる。弾性片72は、突出端が収容筒18の軸心側に弾性的に寄るように形状付けられている。また、弾性片72の軸心を臨む面の所定位置(周壁58との連結部分付近)には、ハブ14の後退時に環状突起44aに係合する係合溝72aが形成されている。 The accommodating cylinder 18 has a plurality (four in the present embodiment) protruding in the base end direction and the axial center side of the first space 62 at the boundary between the extending cylinder part 66 and the locking cylinder part 68. An elastic piece 72 is provided. The four elastic pieces 72 are provided at equal intervals (90 ° out of phase) along the circumferential direction of the protector 16. The elastic piece 72 is shaped so that the protruding end is elastically shifted toward the axial center side of the housing cylinder 18. In addition, an engagement groove 72a that engages with the annular protrusion 44a when the hub 14 is retracted is formed at a predetermined position (near the connecting portion with the peripheral wall 58) of the surface facing the axis of the elastic piece 72.
 4つの弾性片72は、使用前及び使用時に、ハブ14の閉塞部46に形成された4つの切り欠き部46aに収容される。これにより、ハブ14は、プロテクタ16との相対回転が規制され、また四方の弾性片72によってがたつきが抑えられる。 The four elastic pieces 72 are accommodated in the four cutout portions 46a formed in the closing portion 46 of the hub 14 before and during use. As a result, the hub 14 is restricted from rotating relative to the protector 16, and rattling is suppressed by the four elastic pieces 72.
 図1に戻り、プロテクタ16の翼部材20は、収容筒18の取付筒部64に強固に固着される。翼部材20は、収容筒18よりも高い可撓性且つ弾性率が低い(すなわち弾性体からなる)樹脂材料により構成されている。翼部材20を構成する弾性体としては、例えば、天然ゴム、イソプレンゴム、ブチルゴム、クロロプレンゴム、ニトリル-ブタジエンゴム、スチレン-ブタジエンゴム、シリコーンゴム等の各種ゴム材料(特に、加硫処理したもの)や、スチレン系エラストマー、水添スチレン系エラストマー、及びこれらスチレン系エラストマーにポリエチレン、ポリプロピレン、ポリブテン、α-オレフィン共重合体等のポリオレフィン、これらの樹脂に流動パラフィン、プロセスオイル等のオイルやタルク、キャスト、マイカ等の粉体無機物を混合したもの、さらにポリ塩化ビニル系エラストマー、オレフィン系エラストマー、ポリエステル系エラストマー、ポリアミド系エラストマー、ポリウレタン系エラストマー、又はこれらの混合物等があげられる。医療用針10は、翼部材20が収容筒18よりも柔軟に形成されることで、留置状態で供血者の体表への当たりを弱め、供血者の負担を軽減することができる。 1, the wing member 20 of the protector 16 is firmly fixed to the mounting cylinder portion 64 of the housing cylinder 18. The wing member 20 is made of a resin material that is higher in flexibility and elastic modulus than the housing cylinder 18 (that is, made of an elastic body). Examples of the elastic body constituting the wing member 20 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber (especially those subjected to vulcanization treatment). And styrene elastomers, hydrogenated styrene elastomers, polyolefins such as polyethylene, polypropylene, polybutene, and α-olefin copolymers in these styrene elastomers, liquid paraffin, oils such as process oil, talc, cast , Powdered inorganic materials such as mica, polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, or mixtures thereof. . Since the wing member 20 is formed more flexibly than the accommodating cylinder 18 in the medical needle 10, the contact with the body surface of the blood donor can be weakened in the indwelling state, and the burden on the blood donor can be reduced.
 翼部材20は、図1~図4Bに示すように、取付筒部64に装着される軸部74と、軸部74の下部(体表固定予定部)に連なり幅方向外側に突出する一対のウイング22と、軸部74から先端方向に突出する先端部76(嵌合部:遮断部)とを有する。 As shown in FIGS. 1 to 4B, the wing member 20 is connected to a shaft portion 74 attached to the mounting cylinder portion 64 and a pair of lower portions (body surface fixing scheduled portions) of the shaft portion 74 and projecting outward in the width direction. It has the wing 22 and the front-end | tip part 76 (fitting part: interruption | blocking part) which protrudes from the axial part 74 to a front-end | tip direction.
 上述したように、翼部材20の軸部74は、プロテクタ16の一部分を構成する。軸部74は、収容筒18の取付筒部64よりも太く且つ取付筒部64の軸方向長さに一致する長さに形成される。軸部74の内部には、取付筒部64の外周面に密着する取付孔74aが設けられる。 As described above, the shaft portion 74 of the wing member 20 constitutes a part of the protector 16. The shaft portion 74 is formed to have a length that is thicker than the mounting tube portion 64 of the housing tube 18 and matches the axial length of the mounting tube portion 64. An attachment hole 74 a that is in close contact with the outer peripheral surface of the attachment cylinder portion 64 is provided inside the shaft portion 74.
 一対のウイング22は、軸部74に連結して薄肉に形成された薄肉部82と、薄肉部82の突出辺に連なり薄肉部82よりも厚肉に形成された外翼部84とを有する。一対のウイング22は、医療従事者に操作されない通常状態では、軸部74の幅方向外側に向かって突出している。そして、針体12の穿刺時に、医療従事者に軸部74の上方で、一対の外翼部84が相互に合わされて摘まれることで、針体12の穿刺操作を良好に実施させる。 The pair of wings 22 includes a thin portion 82 that is thinly connected to the shaft portion 74, and an outer wing portion 84 that is connected to the protruding side of the thin portion 82 and is thicker than the thin portion 82. The pair of wings 22 protrude outward in the width direction of the shaft portion 74 in a normal state where the pair of wings 22 is not operated by a medical worker. Then, when the needle body 12 is punctured, a pair of outer wing portions 84 are put together and picked up by the medical staff above the shaft portion 74, so that the puncture operation of the needle body 12 is favorably performed.
 このため、薄肉部82は、弱い力で弾性変形可能になっており、穿刺時には、上側面が軸部74に向かって変形する。薄肉部82と外翼部84の先端縁は、基端方向に向かって傾斜しており、穿刺時に針体12及び先端部76を見え易くしている。 Therefore, the thin-walled portion 82 can be elastically deformed with a weak force, and the upper side surface is deformed toward the shaft portion 74 at the time of puncturing. The distal end edges of the thin wall portion 82 and the outer wing portion 84 are inclined toward the proximal direction so that the needle body 12 and the distal end portion 76 can be easily seen during puncturing.
 また、一対の外翼部84は、平面視で、薄肉部82よりも基端方向に突出した長方形状に形成されている。一対の外翼部84同士が接触する対向面の一方には、翼部材20の幅方向に長い複数(本実施形態では2つ)の凸状部84aが形成されている。また対向面の他方には、凸状部84aに対応する位置に幅方向に長い複数(2つ)の凹状部84bが形成されている。そのため翼部材20は、一対の外翼部84の重ね合わせ状態で、外翼部84同士のずれが抑制される。 Further, the pair of outer wing portions 84 are formed in a rectangular shape protruding in the proximal direction from the thin portion 82 in plan view. A plurality (two in this embodiment) of convex portions 84a that are long in the width direction of the wing member 20 are formed on one of the facing surfaces where the pair of outer wing portions 84 come into contact with each other. On the other side of the opposing surface, a plurality (two) of concave portions 84b that are long in the width direction are formed at positions corresponding to the convex portions 84a. Therefore, in the wing member 20, the shift between the outer wing portions 84 is suppressed in a state where the pair of outer wing portions 84 are overlapped.
 先端部76は、軸部74の先端面から先端方向に突出する円筒状の部位である。この先端部76には、使用前に、図3Aに示すキャップ24が取り付けられている。先端部76の内部には、収容筒18の取付状態で、第1空間62に連通して第1空間62と共に収容空間60を構成する第2空間86が形成されている。 The front end portion 76 is a cylindrical portion that protrudes from the front end surface of the shaft portion 74 in the front end direction. The cap 24 shown in FIG. 3A is attached to the tip 76 before use. A second space 86 that communicates with the first space 62 and forms the accommodation space 60 together with the first space 62 is formed inside the distal end portion 76 in a state where the accommodation cylinder 18 is attached.
 先端部76は、第2空間86を周方向に囲う周壁88(壁部)を有し、軸部74に連なる基端側連結部90と、基端側連結部90の先端側で多少先細りに形成された先端側先細り部92とを形成している。基端側連結部90側の第2空間86には、使用前及び使用時に、ハブ14の環状突起44aよりも先端側が挿入される。すなわち、基端側連結部90の周壁88は、ハブ14の先端により内側から支持され、使用前には、この状態の先端部76の外側にキャップ24が装着される。 The distal end portion 76 has a peripheral wall 88 (wall portion) that surrounds the second space 86 in the circumferential direction, and is slightly tapered at the proximal end side connecting portion 90 that continues to the shaft portion 74 and the distal end side of the proximal end side connecting portion 90. A tip end side tapered portion 92 is formed. The distal end side of the annular protrusion 44a of the hub 14 is inserted into the second space 86 on the proximal end side connecting portion 90 side before and during use. That is, the peripheral wall 88 of the base end side connecting portion 90 is supported from the inside by the tip of the hub 14, and the cap 24 is attached to the outside of the tip portion 76 in this state before use.
 ここで、図3Aに示すように、製品提供状態で針体12を覆うキャップ24は、軸方向に長い円筒状に形成され、その内部に針体12及び先端部76を配置する配置空間25を有する。このキャップ24を構成する筒壁24aの基端側の内径は、先端部76の基端側連結部90の外径よりも若干小径(又は同径)に形成されており、キャップ24と先端部76の取付状態で基端側連結部90の外周面に密着する。 Here, as shown in FIG. 3A, the cap 24 that covers the needle body 12 in the product provision state is formed in a cylindrical shape that is long in the axial direction, and an arrangement space 25 in which the needle body 12 and the distal end portion 76 are disposed is provided therein. Have. An inner diameter on the proximal end side of the cylindrical wall 24a constituting the cap 24 is formed to be slightly smaller (or the same diameter) than an outer diameter of the proximal end side connecting portion 90 of the distal end portion 76, and the cap 24 and the distal end portion are formed. In the attached state of 76, it is in close contact with the outer peripheral surface of the proximal end side connecting portion 90.
 キャップ24を構成する材料は、翼部材20よりも硬質な材料であれば特に限定されず、例えば、上記のハブ14であげた樹脂材料を適宜採用するとよい。本実施形態のキャップ24は、ポリプロピレンを採用している。 The material constituting the cap 24 is not particularly limited as long as it is a material harder than the wing member 20. For example, the resin material mentioned in the hub 14 may be appropriately adopted. The cap 24 of this embodiment employs polypropylene.
 この場合、先端部76は、弾性率が低いことにより弾性変形容易な部位となり、その内側の第2空間86には、硬質なハブ14の先端が進入する。換言すれば、プロテクタ16の先端側は、使用前に、硬質なハブ14及びキャップ24の間に先端部76を挟んだ状態となる(図6も参照)。そのため、基端側連結部90の周壁88は、ハブ14とキャップ24の隙間を埋めるように肉部分が動き、径方向外側や径方向内側に撓むことなく、ハブ14及びキャップ24との閉塞状態を維持する。 In this case, the distal end portion 76 becomes a portion that is easily elastically deformed due to the low elastic modulus, and the distal end of the hard hub 14 enters the second space 86 inside thereof. In other words, the tip end side of the protector 16 is in a state where the tip end portion 76 is sandwiched between the hard hub 14 and the cap 24 before use (see also FIG. 6). Therefore, the peripheral wall 88 of the base end side connecting portion 90 moves so that the gap between the hub 14 and the cap 24 is filled, and the hub 14 and the cap 24 are closed without being bent radially outward or radially inward. Maintain state.
 すなわち、医療用針10は、使用前において、キャップ24の筒壁24aと基端側連結部90の周壁88とが強固に密着し合うと共に、基端側連結部90の周壁88とハブ14の先端部も強固に密着し合っている。その結果、キャップ24の配置空間25及び先端部76の第2空間86は、医療用針10の外部及び第1空間62から高い気密性をもって遮断される。 In other words, before use, the medical needle 10 has the cylindrical wall 24a of the cap 24 and the peripheral wall 88 of the proximal end side connecting portion 90 firmly adhered to each other, and the peripheral wall 88 of the proximal end side connecting portion 90 and the hub 14 are in close contact with each other. The tip is also firmly attached. As a result, the arrangement space 25 of the cap 24 and the second space 86 of the distal end 76 are blocked from the outside of the medical needle 10 and the first space 62 with high airtightness.
[規則91に基づく訂正 28.06.2016] 
 また、キャップ24は、先端部76の先端側先細り部92とは非接触であり、基端側連結部90の外周面に対してのみ密着する。従って、キャップ24と翼部材20は、高い気密性を有して装着されるものの、筒壁24aと周壁88が面接触する部分は少なく、キャップ24を軸方向に抜くことで簡単に取り外すことができる。勿論、医療用針10は、キャップ24が先端部76の外周面全面に接触して気密性を高めた構成であってもよい。
[Correction 28.06.2016 under Rule 91]
Further, the cap 24 is not in contact with the distal end side tapered portion 92 of the distal end portion 76 and is in close contact with only the outer peripheral surface of the proximal end side connecting portion 90. Therefore, although the cap 24 and the wing member 20 are mounted with high airtightness, there are few portions where the cylindrical wall 24a and the peripheral wall 88 are in surface contact, and the cap 24 and the wing member 20 can be easily removed by removing the cap 24 in the axial direction. it can. Of course, the medical needle 10 may have a configuration in which the cap 24 is in contact with the entire outer peripheral surface of the distal end portion 76 to improve airtightness.
 先端側先細り部92の先端には、周壁88から内側に傾斜してすり鉢状に形成された返し部94が設けられ、この返し部94の突出端によって第2空間86に連通する先端開口76aが形成されている。先端開口76aは、針体12の後退移動時に針体12が非接触で通過できるように比較的大径に形成されている。先端開口76aの口径は、針体12の外径にもよるが、例えば、針体12との間に0.3mm以上の隙間が形成されるように設定されると、針体12を非接触で良好に通過させ得る。本実施形態では、先端開口76aの口径を2mmに設定している。なお、医療用針10は、返し部94を備えていなくてもよい。 At the tip of the tip-side tapered portion 92, a return portion 94 that is inclined inward from the peripheral wall 88 and formed in a mortar shape is provided, and a tip opening 76a that communicates with the second space 86 by the protruding end of the return portion 94 is provided. Is formed. The distal end opening 76a is formed to have a relatively large diameter so that the needle body 12 can pass in a non-contact manner when the needle body 12 moves backward. Although the diameter of the tip opening 76a depends on the outer diameter of the needle body 12, for example, when the clearance of 0.3 mm or more is formed between the needle body 12 and the needle body 12, the needle body 12 is not contacted. Can pass well. In the present embodiment, the diameter of the tip opening 76a is set to 2 mm. Note that the medical needle 10 does not have to include the return portion 94.
 本実施形態に係る医療用針10は、基本的には以上のように構成され、以下、その作用効果について説明する。 The medical needle 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
 医療用針10は、全血の献血に使用するための採血セットとして提供される。医療用針10の組立時には、針体12及びハブ14を固着した状態のものをまず適宜の滅菌処理により滅菌し、その後にプロテクタ16に組み付ける。具体的には、翼部材20が収容筒18の取付筒部64に固定され、ハブ14のアーム50と収容筒18の係合孔70を係合させることで、ハブ14とプロテクタ16を一体的に取扱可能とする。この組付状態で針体12は翼部材20の先端部76から突出する。 The medical needle 10 is provided as a blood collection set for use in donating whole blood. When the medical needle 10 is assembled, the needle body 12 and the hub 14 fixed state are first sterilized by an appropriate sterilization process and then assembled to the protector 16. Specifically, the wing member 20 is fixed to the mounting cylinder portion 64 of the housing cylinder 18, and the hub 14 and the protector 16 are integrated with each other by engaging the arm 50 of the hub 14 and the engagement hole 70 of the housing cylinder 18. Can be handled. In this assembled state, the needle body 12 protrudes from the tip 76 of the wing member 20.
 また、針体12及び先端部76の外側には、キャップ24(図3A参照)が装着され、ハブ14の基端面には、採血セットの血液バッグ及びチューブ26等が接続されて製品提供前の採血セットが構成される。そして、医療用針10は、採血セットの状態で高圧蒸気滅菌処理(オートクレーブ滅菌処理)が行われる。 Further, a cap 24 (see FIG. 3A) is attached to the outside of the needle body 12 and the distal end portion 76, and a blood bag and a tube 26 of a blood collection set are connected to the base end surface of the hub 14 before providing the product. A blood collection set is configured. The medical needle 10 is subjected to high-pressure steam sterilization (autoclave sterilization) in a blood collection set.
 高圧蒸気滅菌処理では、図示しないオートクレーブ装置のタンク内に水(液体)を貯留すると共に、医療用針10(採血セット)を投入する。オートクレーブ装置は、公知のものを適用してよい。例えば、オートクレーブ装置は、閉塞したタンク内を高圧化することで、水(蒸気)の温度を100℃以上にして、医療用針10の洗浄及び滅菌を行う。 In the high-pressure steam sterilization process, water (liquid) is stored in a tank of an autoclave device (not shown) and a medical needle 10 (blood collection set) is introduced. A well-known thing may be applied for an autoclave apparatus. For example, the autoclave device performs cleaning and sterilization of the medical needle 10 by increasing the temperature of water (steam) to 100 ° C. or higher by increasing the pressure in the closed tank.
 この高圧蒸気滅菌処理時には、医療用針10に多量の蒸気がかかる。しかしながら図6に示すように、先端部76は第2空間86にハブ14の先端部が挿入されていることで、内側への撓みが防止される。そのため、キャップ24と先端部76は、強固な密着状態を維持し、キャップ24と先端部76の接触部分の間から配置空間25に水が浸入することを遮断する。 A large amount of steam is applied to the medical needle 10 during this high-pressure steam sterilization treatment. However, as shown in FIG. 6, the distal end portion 76 is prevented from bending inward because the distal end portion of the hub 14 is inserted into the second space 86. Therefore, the cap 24 and the distal end portion 76 maintain a strong contact state, and block water from entering the arrangement space 25 from between the contact portions of the cap 24 and the distal end portion 76.
 さらに、医療用針10は、収容筒18の基端側(係止筒部68)において、ハブ14の閉塞壁46bが収容筒18の周壁58に接触し、この接触部分よりも先端側の第1空間62を遮断している。そのため、接触部分よりも先端側の第1空間62に蒸気が浸入することが抑制され、ハブ14と収容筒18の間に水が溜まらないようにすることができる。特に、閉塞壁46bの突出端面47aと収容筒18の内面47bとは、互いにテーパ状に形成されて面接触している。そのため、ハブ14及び収容筒18がそれぞれ硬質に形成されていても、この閉塞構造47は第1空間62の閉塞性を高め得る。 Further, in the medical needle 10, the closing wall 46 b of the hub 14 is in contact with the peripheral wall 58 of the housing cylinder 18 on the proximal end side (the locking cylinder portion 68) of the housing cylinder 18, and the medical needle 10 One space 62 is blocked. Therefore, it is possible to prevent the vapor from entering the first space 62 on the tip side of the contact portion, and to prevent water from collecting between the hub 14 and the housing cylinder 18. In particular, the protruding end surface 47a of the blocking wall 46b and the inner surface 47b of the housing cylinder 18 are formed in a tapered shape and are in surface contact with each other. Therefore, even if the hub 14 and the housing cylinder 18 are each formed rigidly, the closing structure 47 can improve the closing property of the first space 62.
 また仮に、蒸気が閉塞壁46bよりも先端側の第1空間62に浸入したとしても、キャップ24が嵌合した先端部76(基端側連結部90)の周壁88とハブ14の先端とが気密に接触している。このため、ハブ14よりも先端側の空間(第2空間86や配置空間25)に対する蒸気の浸入が強固に遮断される。従って、医療用針10は、高圧蒸気滅菌処理時に、血管に直接挿入される針体12に水が付着することを確実に防止することができる。さらに、医療用針10の先端部76は、高圧蒸気滅菌処理後の製品保管時にも、外気(菌を含む)が配置空間25に侵入することを遮断することができる。 Even if the vapor enters the first space 62 on the distal end side of the blocking wall 46b, the peripheral wall 88 of the distal end portion 76 (base end side coupling portion 90) to which the cap 24 is fitted and the distal end of the hub 14 are not connected. Airtight contact. For this reason, the infiltration of the vapor into the space (the second space 86 and the arrangement space 25) on the tip side of the hub 14 is firmly blocked. Therefore, the medical needle 10 can reliably prevent water from adhering to the needle body 12 inserted directly into the blood vessel during the high-pressure steam sterilization process. Furthermore, the distal end portion 76 of the medical needle 10 can block outside air (including bacteria) from entering the arrangement space 25 even during product storage after high-pressure steam sterilization.
 また、本発明によれば、簡単な構造で、従来Oリングや別部品を用いて気密性を維持するために必要だった精密な設計と素材選択を行わなくても、高圧蒸気圧滅菌処理時における熱可塑性部品の収縮、或いは変形といったこれらの課題を解決できる。 In addition, according to the present invention, it is possible to perform high-pressure steam pressure sterilization processing with a simple structure without performing precise design and material selection that are conventionally required to maintain airtightness using an O-ring or another part. These problems such as shrinkage or deformation of the thermoplastic part can be solved.
 以上のように、第1実施形態に係る医療用針10は、針体12の穿刺前の状態で、ハブ14が先端部76の内周面全周に密着すると共に、先端部76の外周面全周にキャップ24が密着することで、キャップ24の配置空間25を気密に閉塞することができる。従って、医療用針10は、プロテクタ16とキャップ24の間から配置空間25への蒸気の浸入を確実に防いで、高圧蒸気滅菌処理を良好に実施させることができ、処理後に針体12に水の付着がなくなり、医療用針10は衛生性が高いものとなる。 As described above, in the medical needle 10 according to the first embodiment, the hub 14 is in close contact with the entire inner peripheral surface of the distal end portion 76 and the outer peripheral surface of the distal end portion 76 before the needle body 12 is punctured. Since the cap 24 is in close contact with the entire circumference, the arrangement space 25 of the cap 24 can be hermetically closed. Therefore, the medical needle 10 can reliably prevent the invasion of steam from between the protector 16 and the cap 24 into the arrangement space 25 and can perform the high-pressure steam sterilization process well. And the medical needle 10 is highly sanitary.
 この場合、先端部76は、ハブ14とキャップ24の間に挟持されることで、その肉部分が弾性的に動いて、ハブ14と先端部76及びキャップ24と先端部76の間を隙間なく密着させることができる。また、プロテクタ16が収容筒18と翼部材20を備えることで、医療用針10は、キャップ24を弾性的に装着させる弾性部を簡単に形成することができる。さらに、ハブ14とプロテクタ16は、収容空間60の基端側に閉塞構造47を有することで、高圧蒸気滅菌処理時に、閉塞構造47よりも先端側の収容空間60に蒸気が浸入することを抑制することができる。よって、ハブ14の衛生性も高められる。 In this case, the front end portion 76 is sandwiched between the hub 14 and the cap 24, so that the flesh portion moves elastically, and there is no gap between the hub 14 and the front end portion 76 and between the cap 24 and the front end portion 76. It can be adhered. In addition, since the protector 16 includes the housing cylinder 18 and the wing member 20, the medical needle 10 can easily form an elastic portion on which the cap 24 is elastically attached. Furthermore, the hub 14 and the protector 16 have the closed structure 47 on the proximal end side of the storage space 60, thereby suppressing steam from entering the storage space 60 on the distal side of the closed structure 47 during the high-pressure steam sterilization process. can do. Therefore, the hygiene of the hub 14 is also improved.
 なお、本発明に係る医療用針10は、上記の実施形態に限定されるものではなく、種々の変形例及び応用例をとり得る。以下、本発明に係る医療用針10の他の実施形態について幾つか説明する。なお、以降の説明において、第1実施形態の医療用針10と同一の構成又は同一の機能を有する構成については同じ符号を付しその詳細な説明については省略する。 In addition, the medical needle 10 according to the present invention is not limited to the above-described embodiment, and various modifications and application examples can be taken. Hereinafter, some other embodiments of the medical needle 10 according to the present invention will be described. In the following description, the same reference numerals are given to the same configuration or the same function as the medical needle 10 of the first embodiment, and the detailed description thereof is omitted.
〔第2実施形態〕
 図7~図9に示す第2実施形態に係る医療用針10Aは、医療用針10と同様に、針体12、ハブ14、プロテクタ16を有する留置針として構成されるが、プロテクタ16内にOリング100(シール部材:遮断部)を備える点で、医療用針10と異なる。
[Second Embodiment]
A medical needle 10A according to the second embodiment shown in FIGS. 7 to 9 is configured as an indwelling needle having a needle body 12, a hub 14, and a protector 16, like the medical needle 10. It differs from the medical needle 10 in that an O-ring 100 (seal member: blocking part) is provided.
 具体的には、医療用針10Aのハブ14は、使用前及び使用時に、シャフト部40と、操作部42と有する。そして、シャフト部40の外周面には、先端側位置に係止部44が設けられると共に、基端側位置に閉塞部102が設けられる。 Specifically, the hub 14 of the medical needle 10A has a shaft portion 40 and an operation portion 42 before and during use. On the outer peripheral surface of the shaft portion 40, a locking portion 44 is provided at the distal end side position, and a closing portion 102 is provided at the proximal end side position.
 閉塞部102は、プロテクタ16の収容筒18と共に、収容空間60を気密に閉塞する閉塞構造103(図8B参照)を形成する。閉塞部102は、シャフト部40の外周面から径方向外側に突出して周方向に沿ってリング状に周回する一対の円盤部104、106と、一対の円盤部104、106の間に配置される上記のOリング100とを含む。 The closing part 102 forms a closing structure 103 (see FIG. 8B) that airtightly closes the accommodation space 60 together with the accommodation cylinder 18 of the protector 16. The blocking portion 102 is disposed between a pair of disk portions 104 and 106 that protrude radially outward from the outer peripheral surface of the shaft portion 40 and circulate in a ring shape along the circumferential direction, and the pair of disk portions 104 and 106. Including the O-ring 100 described above.
 一対の円盤部104、106は、図8Bに示すように、プロテクタ16内にハブ14を収容した状態で、収容空間60を構成する周壁58(内面)の近傍に位置する。すなわち一対の円盤部104、106は周壁58に非接触である。一対の円盤部104、106は、Oリング100を隙間なく収容可能な間隔の溝を形成している。 As shown in FIG. 8B, the pair of disk portions 104 and 106 are positioned in the vicinity of the peripheral wall 58 (inner surface) constituting the accommodation space 60 in a state where the hub 14 is accommodated in the protector 16. That is, the pair of disk portions 104 and 106 are not in contact with the peripheral wall 58. The pair of disk portions 104 and 106 form a groove having an interval that can accommodate the O-ring 100 without a gap.
 Oリング100は、一対の円盤部104、106の間でハブ14の外周面上を周方向に沿って配置される。Oリング100の外側部分は、一対の円盤部104、106の外縁よりも径方向外側に多少突出している。Oリング100は、ハブ14をプロテクタ16の収容空間60に収容した状態で、収容筒18の周壁58の周方向全周にわたって接触する。これによりOリング100は、このOリング100よりも先端側の収容空間60を気密に閉塞して、流体(蒸気や菌)の浸入を防止する。 The O-ring 100 is disposed along the circumferential direction on the outer peripheral surface of the hub 14 between the pair of disk portions 104 and 106. The outer portion of the O-ring 100 slightly protrudes outward in the radial direction from the outer edges of the pair of disk portions 104 and 106. The O-ring 100 contacts the entire circumference of the circumferential wall 58 of the housing cylinder 18 in a state where the hub 14 is housed in the housing space 60 of the protector 16. As a result, the O-ring 100 hermetically closes the accommodation space 60 on the tip side of the O-ring 100 and prevents the intrusion of fluid (steam or bacteria).
 Oリング100を構成する材料は、特に限定されるものではないが、適切な弾性力を有するものが望ましく、例えば、上述した翼部材20の材料を適宜適用するとよい。 The material constituting the O-ring 100 is not particularly limited, but a material having an appropriate elastic force is desirable. For example, the material of the wing member 20 described above may be appropriately applied.
 第2実施形態に係る医療用針10Aは、基本的には以上のように構成され、以下、その作用効果について説明する。医療用針10Aは、第1実施形態に係る医療用針10と同様に、採血セットに組み立てられて、採血セットの状態で高圧蒸気滅菌処理(オートクレーブ滅菌処理)が行われる。 The medical needle 10A according to the second embodiment is basically configured as described above, and the operation and effect thereof will be described below. Similarly to the medical needle 10 according to the first embodiment, the medical needle 10A is assembled into a blood collection set and subjected to high-pressure steam sterilization (autoclave sterilization) in the state of the blood collection set.
 高圧蒸気滅菌処理時には、医療用針10Aに多量の蒸気がかかる。しかしながら図9に示すように、キャップ24と先端部76は、強固な密着状態を維持し、キャップ24と先端部76の接触部分の間から配置空間25に流体(蒸気や菌)が浸入することを遮断する。さらに、医療用針10Aは、第1空間62の基端側において、ハブ14に設けたOリング100が収容筒18の周壁58に接触し、この接触部分よりも先端側の第1空間62を気密に閉塞している。従って、Oリング100よりも先端側の第1空間62への蒸気や菌の流動が確実に遮断される。 During the high-pressure steam sterilization treatment, a large amount of steam is applied to the medical needle 10A. However, as shown in FIG. 9, the cap 24 and the tip 76 are maintained in a tight contact state, and fluid (steam or bacteria) enters the arrangement space 25 from between the contact portions of the cap 24 and the tip 76. Shut off. Further, in the medical needle 10 </ b> A, the O-ring 100 provided in the hub 14 contacts the peripheral wall 58 of the housing cylinder 18 on the proximal end side of the first space 62, and the first space 62 on the distal end side with respect to this contact portion. Airtightly blocked. Therefore, the flow of steam and bacteria to the first space 62 on the tip side of the O-ring 100 is reliably blocked.
 特に、Oリング100は、係止筒部68内で比較的大きく形成されて弾性変形し、且つ一対の円盤部104、106によりハブ14の軸方向への移動が規制されて収容筒18の係合孔70よりも先端位置を閉塞している。そのため、Oリング100は高いシール性を発揮してOリング100よりも先端側の第1空間62を確実に閉塞する。また、閉塞部102は、ハブ14の基端側に設けられていることで、プロテクタ16に対しハブ14を基端方向に後退させた際に、Oリング100を直ぐに外部に露出させる。そのため医療従事者は、ハブ14の後退操作を弱い力で行うことができる。 In particular, the O-ring 100 is formed relatively large in the locking cylinder portion 68 and elastically deforms, and the movement of the hub 14 in the axial direction is restricted by the pair of disk portions 104 and 106, so that the engagement cylinder 18 is engaged. The tip position is blocked from the joint hole 70. Therefore, the O-ring 100 exhibits high sealing performance and reliably closes the first space 62 on the tip side of the O-ring 100. Further, since the closing portion 102 is provided on the proximal end side of the hub 14, when the hub 14 is retracted in the proximal direction with respect to the protector 16, the O-ring 100 is immediately exposed to the outside. Therefore, the medical staff can perform the backward operation of the hub 14 with a weak force.
 以上のように、第2実施形態に係る医療用針10Aは、プロテクタ16の内面に接触するOリング100が接触部分よりも先端側の収容空間60を気密に閉塞する。このため、第2空間86に連通する可能性がある針体12の配置空間25に、蒸気や菌が浸入するのを確実に防ぐことができる。従って、医療用針10Aは、高圧蒸気滅菌処理を良好に実施することが可能になり、処理後に針体12に水の付着がなくなり、針体12の衛生性を高くすることができる。 As described above, in the medical needle 10A according to the second embodiment, the O-ring 100 that comes into contact with the inner surface of the protector 16 airtightly closes the accommodation space 60 on the tip side of the contact portion. For this reason, it can prevent reliably that vapor | steam and microbe enter | penetrate into the arrangement | positioning space 25 of the needle body 12 which may be connected to the 2nd space 86. FIG. Therefore, the medical needle 10A can be well subjected to high-pressure steam sterilization, and no water adheres to the needle body 12 after the treatment, so that the hygiene of the needle body 12 can be enhanced.
 この場合、Oリング100が収容空間60内の基端側位置に配置されることで、医療用針10Aは、高圧蒸気滅菌処理を行う際に、Oリング100よりも前側に延在するハブ14に対しても蒸気や菌の浸入を防止することができる。よって、ハブ14の衛生性も高められる。 In this case, the O-ring 100 is arranged at the proximal end side position in the accommodation space 60, so that the medical needle 10A extends to the front side of the O-ring 100 when performing the high-pressure steam sterilization process. Against this, it is possible to prevent the invasion of steam and bacteria. Therefore, the hygiene of the hub 14 is also improved.
 また、医療用針10Aは、上記の実施形態に限定されるものではなく、種々の変形例及び応用例をとり得る。例えば、収容空間60を閉塞するシール部材は、Oリング100に限定されず、周壁58との間で気密に閉塞可能な種々の部材を適用してよい。例えば、弾性体からなるブロック状の部材をハブ14の途中位置に設けてもよく、ハブ14の外周面に弾性体からなる膜材を貼り付けてもよい。以下、医療用針10Aの変形例について幾つか例をあげて説明する。 Further, the medical needle 10A is not limited to the above-described embodiment, and various modifications and application examples can be taken. For example, the sealing member that closes the accommodation space 60 is not limited to the O-ring 100, and various members that can be airtightly closed with the peripheral wall 58 may be applied. For example, a block-shaped member made of an elastic body may be provided in the middle of the hub 14, and a film material made of an elastic body may be attached to the outer peripheral surface of the hub 14. Hereinafter, some modified examples of the medical needle 10A will be described with some examples.
 図10に示す第1変形例に係るハブ110は、閉塞部112をハブ110の先端側に設けた点で、本実施形態に係るハブ14と異なる。閉塞部112は、閉塞部102と同様に、ハブ110の先端側外周面から径方向外側に突出する一対の円盤部114、116と、一対の円盤部114、116の間に配置されるOリング118とを有する。 The hub 110 according to the first modification shown in FIG. 10 is different from the hub 14 according to the present embodiment in that the closing portion 112 is provided on the distal end side of the hub 110. As with the closing portion 102, the closing portion 112 is a pair of disk portions 114 and 116 that protrude radially outward from the outer peripheral surface of the hub 110, and an O-ring disposed between the pair of disk portions 114 and 116. 118.
 一対の円盤部114、116は、収容筒18の周壁58(内面)に対して非接触となるように短く突出している。また、一対の円盤部114、116の間隔は、ハブ14の一対の円盤部104、106よりも短く形成され、同じく小さな形状に形成されたOリング118を収容する。 The pair of disk portions 114 and 116 protrudes short so as not to contact the peripheral wall 58 (inner surface) of the housing cylinder 18. The distance between the pair of disk portions 114 and 116 is shorter than the pair of disk portions 104 and 106 of the hub 14 and accommodates an O-ring 118 that is similarly formed in a small shape.
 Oリング118は、ハブ110への取付状態で、一対の円盤部114、116よりも径方向外側に突出して周壁58の周方向全周にわたって気密に接触する。これにより、Oリング118よりも先端側の収容空間60(つまり、第1空間62に連通する第2空間86)及び配置空間25が閉塞される。すなわちOリング118も、Oリング100と同様の効果を得ることができ、配置空間25内の針体12への蒸気や菌の侵入を防ぐことができる。要するに、ハブ14、110の軸方向上におけるシール部材の設置位置は、特に限定されるものではない。 When the O-ring 118 is attached to the hub 110, the O-ring 118 protrudes radially outward from the pair of disk portions 114 and 116 and comes into air-tight contact over the entire circumferential direction of the peripheral wall 58. As a result, the accommodation space 60 (that is, the second space 86 communicating with the first space 62) and the arrangement space 25 on the tip side of the O-ring 118 are closed. That is, the O-ring 118 can obtain the same effect as that of the O-ring 100 and can prevent vapor and bacteria from entering the needle body 12 in the arrangement space 25. In short, the installation position of the seal member on the axial direction of the hubs 14 and 110 is not particularly limited.
 また図11に示す第2変形例に係るハブ120は、軸方向基端側に第1閉塞部122を有すると共に、軸方向先端側に第2閉塞部124を有する。第1閉塞部122は、閉塞部102と同様に一対の円盤部104、106、Oリング100を含み、第2閉塞部124は、閉塞部112と同様に一対の円盤部114、116、Oリング118を含む。このようにハブ120の軸方向上に複数のシール部材を設けると、一層閉塞性を高めて高圧蒸気滅菌処理時における蒸気及び菌の浸入をより確実に防ぐことができる。 Further, the hub 120 according to the second modification shown in FIG. 11 has a first closing portion 122 on the axial base end side and a second closing portion 124 on the axial front end side. The first closing portion 122 includes a pair of disk portions 104 and 106 and an O-ring 100 similarly to the closing portion 102, and the second closing portion 124 includes a pair of disk portions 114 and 116 and an O-ring similar to the closing portion 112. 118 is included. If a plurality of seal members are provided in the axial direction of the hub 120 in this way, the occlusion can be further improved and the entry of steam and bacteria during the high-pressure steam sterilization treatment can be prevented more reliably.
 また、図11中に示すように、医療用針10Aは、プロテクタ16を、収容筒18と翼部材20が一体成形された保護部材126で構成してもよい。保護部材126は、Oリング100、118よりも硬い材質により構成され、Oリング100、118の接触により内部の収容空間60が気密にシールされる。この場合、キャップ24と保護部材126の装着箇所には、適宜の密閉手段(例えば、図11中に示すOリング128)が設けられているとよい。 Further, as shown in FIG. 11, in the medical needle 10A, the protector 16 may be constituted by a protective member 126 in which the housing cylinder 18 and the wing member 20 are integrally formed. The protective member 126 is made of a material harder than the O- rings 100 and 118, and the internal accommodation space 60 is hermetically sealed by contact of the O- rings 100 and 118. In this case, an appropriate sealing means (for example, an O-ring 128 shown in FIG. 11) may be provided at a place where the cap 24 and the protection member 126 are attached.
〔第3実施形態〕
 図12~図14Bに示す第3実施形態に係る医療用針10Bは、医療用針10と同様に、針体12、ハブ14、プロテクタ16を有する留置針として構成されるが、プロテクタ16内に閉塞部材54(封止部材:遮断部)を備える点で、医療用針10と異なる。
[Third Embodiment]
A medical needle 10B according to the third embodiment shown in FIGS. 12 to 14B is configured as an indwelling needle having a needle body 12, a hub 14, and a protector 16 in the same manner as the medical needle 10. It differs from the medical needle 10 in that it includes a closing member 54 (sealing member: blocking part).
 具体的には、収容筒18(プロテクタ16)の取付筒部64は、第1空間62の先端側に、閉塞部材54(封止部材)を収容配置するための配置部64aを有している(図13も参照)。配置部64aは、基端側の周壁58の肉厚よりも薄肉に形成されることで、第1空間62の内面を若干大径化したものである。この配置部64aは、閉塞部材54の収容状態で閉塞部材54の基端方向へのずれを規制する。 Specifically, the mounting tube portion 64 of the housing tube 18 (the protector 16) has an arrangement portion 64a for housing and arranging the closing member 54 (sealing member) on the distal end side of the first space 62. (See also FIG. 13). The disposing portion 64a is formed to be thinner than the wall thickness of the peripheral wall 58 on the base end side, so that the inner surface of the first space 62 is slightly enlarged in diameter. The arrangement portion 64 a regulates the displacement of the closing member 54 in the proximal direction in the accommodated state of the closing member 54.
 図12及び図13に示すように、閉塞部材54は、配置部64a内に収容配置され、且つ接着や溶着等の適宜の固着手段により収容筒18に固着される。閉塞部材54は、高圧蒸気滅菌処理時にハブ14とプロテクタ16の間をシールすると共に、使用後に針体12からの血液のこぼれを防ぐ機能を有する。 As shown in FIGS. 12 and 13, the closing member 54 is housed and disposed in the placement portion 64a, and is secured to the housing cylinder 18 by an appropriate securing means such as adhesion or welding. The occlusion member 54 has a function of sealing between the hub 14 and the protector 16 during high-pressure steam sterilization processing and preventing blood spillage from the needle body 12 after use.
 閉塞部材54は、収容筒18の軸方向に沿って平行に突出する側壁54aと、側壁54aの先端側に連なり閉塞部材54の先端側を閉じる先端壁54bとを有し、軸方向が短い有底筒状に形成されている。 The closing member 54 includes a side wall 54a that protrudes in parallel along the axial direction of the housing cylinder 18, and a distal end wall 54b that is connected to the distal end side of the side wall 54a and closes the distal end side of the closing member 54, and has a short axial direction. It is formed in a bottom cylinder shape.
 側壁54aの外周面は、配置部64aの内周面に固着される。側壁54aの内側には、基端側の第1空間62に連通し、ハブ14の先端を挿入可能な挿入空間56が形成されている。挿入空間56を構成する側壁54aは、収容筒18の周壁58の内径よりも小さな内径に設定され、周壁58から第1空間62の径方向内側に向かって突出することで、使用前及び使用時にハブ14の先端の外周面全周にわたって面接触する。すなわち、医療用針10Bは、側壁54aの内面とハブ14の先端の外面が気密に接触して第1空間62の先端側を閉塞する。 The outer peripheral surface of the side wall 54a is fixed to the inner peripheral surface of the arrangement portion 64a. An insertion space 56 that communicates with the first space 62 on the proximal end side and into which the distal end of the hub 14 can be inserted is formed inside the side wall 54a. The side wall 54a that constitutes the insertion space 56 is set to have an inner diameter smaller than the inner diameter of the peripheral wall 58 of the housing cylinder 18, and protrudes from the peripheral wall 58 toward the inner side in the radial direction of the first space 62, so that it can be used before and during use. Surface contact is made over the entire outer peripheral surface of the tip of the hub 14. That is, in the medical needle 10B, the inner surface of the side wall 54a and the outer surface of the distal end of the hub 14 come into airtight contact with each other, and the distal end side of the first space 62 is closed.
 また、閉塞部材54の先端壁54bは、側壁54aの先端から軸方向に直交する方向に膜状に形成され、先端壁54bよりも先端側の空間(第2空間86)と挿入空間56とを遮断する。先端壁54bは、側壁54aよりも厚肉に形成されることで破損等が抑制され、また容易に弾性変形可能となっている。ハブ14の先端は、使用前及び使用時の状態でこの先端壁54bの基端面に接触している。 The distal end wall 54b of the closing member 54 is formed in a film shape in a direction perpendicular to the axial direction from the distal end of the side wall 54a, and a space (second space 86) on the distal end side relative to the distal end wall 54b and the insertion space 56 are formed. Cut off. The tip wall 54b is formed to be thicker than the side wall 54a, so that damage and the like are suppressed, and the tip wall 54b can be easily elastically deformed. The distal end of the hub 14 is in contact with the proximal end surface of the distal end wall 54b before and during use.
 この先端壁54bの中心部には、挿入空間56と第2空間86を連通可能なスリット56a(貫通部分)が形成されている。スリット56aには、使用前及び使用時の状態で針体12が貫通配置される。なお、閉塞部材54は、スリット56aを備えずに、医療用針10Bの組立時に針体12を先端壁54bに突き刺して貫通させる構成でもよい。 A slit 56a (through portion) capable of communicating the insertion space 56 and the second space 86 is formed at the center of the tip wall 54b. The needle body 12 is arranged through the slit 56a before and during use. The closing member 54 may be configured not to include the slit 56a but to pierce and penetrate the needle body 12 into the distal end wall 54b when the medical needle 10B is assembled.
 閉塞部材54を構成する材料は、特に限定されるものではないが、適切な弾性力を有するものが望ましく、例えば、上述した翼部材20の材料を適宜適用するとよい。 The material constituting the closing member 54 is not particularly limited, but a material having an appropriate elastic force is desirable. For example, the material of the wing member 20 described above may be appropriately applied.
 本実施形態に係る医療用針10Bは、基本的には以上のように構成され、以下、その作用効果について説明する。医療用針10Bは、医療用針10、10Aと同様に、採血セットに組み立てられて、採血セットの状態で高圧蒸気滅菌処理(オートクレーブ滅菌処理)が行われる。 The medical needle 10B according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below. Similarly to the medical needles 10 and 10A, the medical needle 10B is assembled into a blood collection set, and is subjected to high-pressure steam sterilization processing (autoclave sterilization processing) in the state of the blood collection set.
 この高圧蒸気滅菌処理時には、医療用針10Bに多量の蒸気がかかる。しかしながら、医療用針10Bは、図13に示すように、収容筒18の基端側(係止筒部68)において、ハブ14の閉塞壁46bが収容筒18の周壁58に接触し、この接触部分よりも先端側の第1空間62を遮断している。そのため、接触部分よりも先端側の第1空間62に対する流体(蒸気や菌)の浸入が抑制される。 During this high-pressure steam sterilization treatment, a large amount of steam is applied to the medical needle 10B. However, as shown in FIG. 13, in the medical needle 10 </ b> B, the blocking wall 46 b of the hub 14 contacts the peripheral wall 58 of the housing cylinder 18 on the proximal end side (locking cylinder portion 68) of the housing cylinder 18. The first space 62 closer to the tip than the portion is blocked. Therefore, infiltration of fluid (steam or bacteria) into the first space 62 on the tip side of the contact portion is suppressed.
 また、蒸気や菌が閉塞壁46bよりも先端側の第1空間62に浸入した場合は、図14Aに示すように、第1空間62の先端側に設けた閉塞部材54が蒸気や菌の先端方向の移動を遮断する。 In addition, when steam or bacteria enter the first space 62 on the tip side of the blocking wall 46b, the blocking member 54 provided on the tip side of the first space 62 has a tip of steam or bacteria as shown in FIG. 14A. Block direction movement.
 すなわち、使用前の医療用針10Bは、収容筒18の周壁58に固着された閉塞部材54の側壁54aとハブ14の先端とが気密に接触している。特に、側壁54aは、収容筒18とハブ14の間で挟まれた状態となっている。そのため、側壁54aは、第1空間62の先端側の隙間を埋めるように肉部分が動き、径方向外側や径方向内側に撓むことなく、ハブ14との閉塞状態を維持する。よって、閉塞部材54よりも先端側の空間(第2空間86や配置空間25)への蒸気及び菌の浸入を強固に遮断する。 That is, in the medical needle 10B before use, the side wall 54a of the closing member 54 fixed to the peripheral wall 58 of the housing cylinder 18 and the tip of the hub 14 are in airtight contact. In particular, the side wall 54 a is sandwiched between the housing cylinder 18 and the hub 14. Therefore, the side wall 54a moves so as to fill the gap on the distal end side of the first space 62, and maintains the closed state with the hub 14 without bending radially outward or radially inward. Therefore, the invasion of vapor and bacteria into the space (second space 86 and arrangement space 25) on the tip side of the closing member 54 is firmly blocked.
 このように滅菌された医療用針10Bは、その使用時に、医療従事者によりキャップ24が取り外されて、針体12が供血者の血管に穿刺される。使用後は、医療従事者により患者の体表から針体12が抜去される。そして、医療従事者は、一対のアーム50の操作突起50bを押圧操作してプロテクタ16とハブ14の係合を解除し、プロテクタ16に対しハブ14を相対的に後退することで針体12をプロテクタ16の収容空間60に誘導していく。この際、翼部材20の先端開口76aが比較的大きく形成されていることで、針体12の穿刺部分は、返し部94に対し非接触で通過することができ、針体12の周囲に付着している血液の拭いが抑えられる。そのため、翼部材20の外面側の衛生性が保たれる。 When the medical needle 10B sterilized in this way is used, the cap 24 is removed by the medical staff, and the needle body 12 is punctured into the blood vessel of the blood donor. After use, the needle body 12 is removed from the patient's body surface by the medical staff. Then, the medical worker presses the operation projections 50b of the pair of arms 50 to release the engagement between the protector 16 and the hub 14, and the needle 14 is moved backward relative to the protector 16 by moving the hub 14 relatively back. It guides to the accommodation space 60 of the protector 16. At this time, since the tip opening 76a of the wing member 20 is formed to be relatively large, the puncture portion of the needle body 12 can pass through the return portion 94 in a non-contact manner and adheres to the periphery of the needle body 12. The wiping of blood that is being done can be suppressed. Therefore, the hygiene of the outer surface side of the wing member 20 is maintained.
 また、ハブ14の先端は、後退操作に伴い、側壁54aとの密着が外れて、閉塞部材54から比較的容易に離脱する。これにより、図14Bに示すように、針体12の針先28が閉塞部材54よりも基端側に移動する。 Also, the front end of the hub 14 comes out of close contact with the side wall 54a and moves away from the closing member 54 with relative ease. Accordingly, as shown in FIG. 14B, the needle tip 28 of the needle body 12 moves to the proximal end side with respect to the closing member 54.
 またハブ14の後退時に、閉塞部材54は、スリット56aに貫通配置されていた針体12の外周面に先端壁54bが接触しつつ、針体12の後退を許容する。このため、針体12の周囲に血液が付着していた場合には、先端壁54bにより血液が拭われる。このように、先端壁54bにより拭われた血液は、医療用針10Bの先端を下に向けて廃棄した場合に、周壁88を伝って先端側に移動する。ここで、医療用針10Bは、プロテクタ16先端の返し部94により環状凹部96を備えており、環状凹部96に血液を溜めて、先端開口76aからの血液のこぼれを抑止することができる。 Further, when the hub 14 is retracted, the closing member 54 allows the needle body 12 to retract while the distal end wall 54b is in contact with the outer peripheral surface of the needle body 12 that is disposed through the slit 56a. For this reason, when the blood has adhered around the needle body 12, the blood is wiped by the tip wall 54b. As described above, the blood wiped by the distal end wall 54b moves to the distal end side along the peripheral wall 88 when the distal end of the medical needle 10B is discarded with the distal end facing downward. Here, the medical needle 10B is provided with an annular recess 96 by the return portion 94 at the tip of the protector 16, and blood can be accumulated in the annular recess 96 to suppress blood spillage from the tip opening 76a.
 また、針体12を閉塞部材54よりも基端側の第1空間62に収容した状態では、針体12が抜けた先端壁54bがスリット56aを径方向内側に狭める(又は閉塞する)ように変形する。そのため、針体12の流動路30等に血液が残っており、医療用針10Bに外力等が加わって血液が針体12から離れたとしても、先端壁54bにより血液が閉塞部材54よりも先端側に流出することを防ぐことができる。 Further, in a state where the needle body 12 is accommodated in the first space 62 on the base end side with respect to the closing member 54, the distal end wall 54b from which the needle body 12 is removed narrows (or closes) the slit 56a radially inward. Deform. Therefore, even if blood remains in the flow path 30 or the like of the needle body 12 and an external force or the like is applied to the medical needle 10B and the blood is separated from the needle body 12, the blood is more distal than the blocking member 54 by the distal end wall 54b. It can be prevented from flowing out to the side.
 以上のように、第3実施形態に係る医療用針10Bは、収容空間60内を気密に閉塞する閉塞部材54を備えることで、医療用針10、10Aと同様の効果を得ることができる。特に、閉塞部材54は、ハブ14の外周面に気密に接触することで、高圧蒸気滅菌処理時にハブ14の先端側の配置空間25に、蒸気や菌が向かうことを確実に遮断することができる。また、医療用針10Bは、閉塞部材54の側壁54aに対してハブ14を相対的に後退させることができる。その一方で、先端壁54bは、スリット56aを容易に狭める又は閉塞することが可能であり、収容空間60に収容した針体12からの血液の流出をより確実に抑止することができる。 As described above, the medical needle 10B according to the third embodiment can obtain the same effects as the medical needles 10 and 10A by including the closing member 54 that closes the inside of the accommodation space 60 in an airtight manner. In particular, the closing member 54 can reliably block steam and bacteria from moving to the arrangement space 25 on the distal end side of the hub 14 during the high-pressure steam sterilization process by making airtight contact with the outer peripheral surface of the hub 14. . Further, the medical needle 10B can retract the hub 14 relative to the side wall 54a of the closing member 54. On the other hand, the distal end wall 54b can easily narrow or close the slit 56a, and can more reliably suppress the outflow of blood from the needle body 12 accommodated in the accommodation space 60.
 また、医療用針10Bは、上記の実施形態に限定されるものではなく、種々の変形例及び応用例をとり得る。例えば、プロテクタ16は、収容筒18と翼部材20を一体成形したものでもよい。また例えば、閉塞部材54は、側壁54aを備えずに、先端壁54bのみによって構成してもよい。先端壁54bが針体12と接触して収容空間60を閉じれば、第2空間86や配置空間25への蒸気及び菌の浸入を防ぐことができるからである。以下、医療用針10Bの他の変形例について、図15A~図15Cを参照して説明する。 Further, the medical needle 10B is not limited to the above-described embodiment, and various modifications and application examples can be taken. For example, the protector 16 may be formed by integrally molding the housing cylinder 18 and the wing member 20. Further, for example, the closing member 54 may be configured by only the tip wall 54b without including the side wall 54a. This is because if the distal end wall 54b comes into contact with the needle body 12 and closes the accommodation space 60, it is possible to prevent vapor and bacteria from entering the second space 86 and the arrangement space 25. Hereinafter, another modification of the medical needle 10B will be described with reference to FIGS. 15A to 15C.
 図15Aに示す第3変形例に係るプロテクタ16Aは、閉塞部材200が側壁200a及び先端壁200bを有するが、先端壁200bが径方向内側に短く突出している点で、プロテクタ16と異なる。すなわち、閉塞部材200は、針体12の外周面に非接触の貫通孔202を有する。このように閉塞部材200を構成しても、側壁200aがハブ14と気密に接触するので、高圧蒸気滅菌処理時に蒸気を遮断することができる。また、この観点からすれば、閉塞部材200は、先端壁200bを備えず側壁200aのみの筒状でもよい。 The protector 16A according to the third modification shown in FIG. 15A is different from the protector 16 in that the closing member 200 has a side wall 200a and a tip wall 200b, but the tip wall 200b protrudes radially inward. That is, the closing member 200 has a non-contact through hole 202 on the outer peripheral surface of the needle body 12. Even if the closing member 200 is configured in this manner, the side wall 200a is in airtight contact with the hub 14, so that steam can be shut off during the high-pressure steam sterilization process. Further, from this point of view, the closing member 200 may have a cylindrical shape including only the side wall 200a without the tip wall 200b.
 図15Bに示す第4変形例に係るプロテクタ16Bは、閉塞部材210がハブ14の先端を気密に収容する構造となっている点で、プロテクタ16、16Aと異なる。詳細には、閉塞部材210の基端面にハブ14の先端の形状に対応する溝部212を有し、この溝部212は使用前及び使用時にハブ14の先端を収容して気密に接触する。これにより、閉塞部材210は、より一層確実に第2空間86や配置空間25への蒸気の浸入を防ぐことができる。 15B is different from the protectors 16 and 16A in that the closing member 210 has a structure in which the tip of the hub 14 is airtightly accommodated. Specifically, a groove portion 212 corresponding to the shape of the tip end of the hub 14 is provided on the base end surface of the closing member 210. The groove portion 212 accommodates the tip end of the hub 14 before and during use, and makes airtight contact. As a result, the closing member 210 can more reliably prevent vapor from entering the second space 86 and the arrangement space 25.
 図15Cに示す第5変形例に係るプロテクタ16Cは、翼部材20Aの先端部76の内部に閉塞部220(封止部材)を一体成形した点で、プロテクタ16、16A、16Bと異なる。この閉塞部220は、使用前に、収容筒18の先端を径方向内側に閉塞して、針体12を貫通配置し針体12の外周面に対し気密に接触している。またハブ14の先端は、使用前及び使用時の状態で閉塞部220の基端面に接触している。このように構成しても、第1空間62に浸入した蒸気は、閉塞部220において遮断され、第2空間86や配置空間25への蒸気の浸入を防ぐことができる。また、閉塞部220を翼部材20Aに一体成形した構成では、部品点数が減り、製造コストや製造時の手間を低減することができる。なお、翼部材20、20Aと一体成形する閉塞部の形状は、図示例に限定されず、閉塞部材54、200、210と同様の形状であってもよい。 A protector 16C according to the fifth modification shown in FIG. 15C is different from the protectors 16, 16A, and 16B in that a closing portion 220 (sealing member) is integrally formed inside the tip portion 76 of the wing member 20A. Prior to use, the closing part 220 closes the distal end of the housing cylinder 18 inward in the radial direction so as to penetrate the needle body 12 and make airtight contact with the outer peripheral surface of the needle body 12. The distal end of the hub 14 is in contact with the proximal end surface of the closing portion 220 before and during use. Even if comprised in this way, the vapor | steam which entered into the 1st space 62 will be interrupted | blocked in the obstruction | occlusion part 220, and the penetration | invasion of the vapor | steam to the 2nd space 86 or the arrangement | positioning space 25 can be prevented. Further, in the configuration in which the closing portion 220 is integrally formed with the wing member 20A, the number of parts is reduced, and the manufacturing cost and labor during manufacturing can be reduced. The shape of the closing portion integrally formed with the wing members 20 and 20A is not limited to the illustrated example, and may be the same shape as the closing members 54, 200, and 210.

Claims (18)

  1.  針体(12)と、
     前記針体(12)を保持する針保持部(14)と、
     前記針体(12)の穿刺前の状態で、前記針保持部(14)を収容して前記針体(12)を先端から露出し、穿刺後に前記針保持部(14)の基端方向の相対移動に伴い前記針体(12)を収容する収容空間(60)を有するプロテクタ(16)と、を備え、
     前記針保持部(14)と前記プロテクタ(16)の間には、流体の流動を遮断する遮断部(76、100、54)が設けられている
     ことを特徴とする医療用針(10、10A、10B)。
    A needle body (12);
    A needle holder (14) for holding the needle body (12);
    In the state before the puncture of the needle body (12), the needle holding portion (14) is accommodated to expose the needle body (12) from the distal end, and after the puncture, the proximal direction of the needle holding portion (14) A protector (16) having an accommodation space (60) for accommodating the needle body (12) with relative movement,
    Between the needle holding part (14) and the protector (16), a blocking part (76, 100, 54) for blocking the flow of fluid is provided. Medical needle (10, 10A) 10B).
  2.  請求項1記載の医療用針(10)において、
     前記針体(12)の穿刺前に前記プロテクタ(16)に装着され、前記針体(12)を覆うキャップ(24)を備え、
     前記プロテクタ(16)は、少なくとも前記キャップ(24)の装着箇所に弾性体からなり前記遮断部として構成される嵌合部(76)を有し、
     前記針体(12)の穿刺前の状態で、前記針保持部(14)が前記嵌合部(76)の内周面全周に密着すると共に、前記キャップ(24)が前記嵌合部(76)の外周面全周に密着する
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 1,
    A cap (24) that is attached to the protector (16) before the needle body (12) is punctured and covers the needle body (12);
    The protector (16) has a fitting part (76) made of an elastic body and configured as the blocking part at least at a place where the cap (24) is attached.
    In a state before the needle body (12) is punctured, the needle holding portion (14) is in close contact with the entire inner peripheral surface of the fitting portion (76), and the cap (24) is attached to the fitting portion ( 76) A medical needle (10) characterized by being in close contact with the entire outer peripheral surface of (76).
  3.  請求項2記載の医療用針(10)において、
     前記嵌合部(76)は、前記針体(12)の穿刺前の状態で、前記針保持部(14)と前記キャップ(24)の間に挟持される
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 2,
    The fitting portion (76) is sandwiched between the needle holding portion (14) and the cap (24) before the needle body (12) is punctured. 10).
  4.  請求項2記載の医療用針(10)において、
     前記プロテクタ(16)は、
     前記針体(12)の収容状態で、該針体(12)の先端まで囲う硬質な収容筒(18)と、
     前記収容筒(18)に装着され、前記収容筒(18)よりも先端方向に突出した前記嵌合部(76)を有する弾性部材(20)と、を備える
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 2,
    The protector (16)
    A rigid housing cylinder (18) surrounding the tip of the needle body (12) in the accommodated state of the needle body (12);
    An elastic member (20) mounted on the housing cylinder (18) and having the fitting portion (76) protruding in the distal direction from the housing cylinder (18). 10).
  5.  請求項4記載の医療用針(10)において、
     前記弾性部材(20)は、前記収容筒(18)に装着される軸部(74)と、前記軸部(74)から幅方向外側に突出するウイング(22)とを有する翼部材に構成され、
     前記嵌合部(76)は、前記軸部(74)に一体成形されている
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 4,
    The elastic member (20) is configured as a wing member having a shaft portion (74) attached to the housing cylinder (18) and a wing (22) protruding outward in the width direction from the shaft portion (74). ,
    The medical needle (10), wherein the fitting portion (76) is integrally formed with the shaft portion (74).
  6.  請求項2記載の医療用針(10)において、
     前記プロテクタ(16)の前記収容空間(60)を構成する内面と前記針保持部(14)の外面とは、前記針体(12)の穿刺前の状態で、前記収容空間(60)の基端側で互いに接触することにより、前記収容空間(60)の先端側への流体の流入を抑制する閉塞構造(47)を形成している
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 2,
    An inner surface constituting the accommodation space (60) of the protector (16) and an outer surface of the needle holding portion (14) are in a state before the needle body (12) is punctured, and the base of the accommodation space (60). A medical needle (10) characterized by forming a closing structure (47) that suppresses the inflow of fluid to the distal end side of the accommodation space (60) by contacting each other on the end side.
  7.  請求項6記載の医療用針(10)において、
     前記閉塞構造(47)は、前記針保持部(14)の外面から突出する閉塞壁(46b)のテーパ状の突出端面(47a)と、前記プロテクタ(16)のテーパ状の内面(47b)とが接触することで構成される
     ことを特徴とする医療用針(10)。
    The medical needle (10) according to claim 6,
    The blocking structure (47) includes a tapered protruding end surface (47a) of a blocking wall (46b) protruding from the outer surface of the needle holding portion (14), and a tapered inner surface (47b) of the protector (16). A medical needle (10), characterized in that it is configured by contact.
  8.  請求項1記載の医療用針(10A)において、
     前記針保持部(14)の外周面には、前記針体(12)の穿刺前の状態で、前記遮断部として構成されて前記プロテクタ(16)の内周面の全周にわたって接触する弾性体からなるシール部材(100)が設けられる
     ことを特徴とする医療用針(10A)。
    The medical needle (10A) according to claim 1,
    An elastic body that is configured as the blocking portion and contacts the entire outer periphery of the protector (16) on the outer peripheral surface of the needle holding portion (14) before the needle body (12) is punctured. A medical needle (10A), characterized in that a sealing member (100) comprising:
  9.  請求項8記載の医療用針(10A)において、
     前記シール部材(100)は、前記針体(12)の穿刺前の状態で、前記収容空間(60)内の基端側位置に配置される
     ことを特徴とする医療用針(10A)。
    The medical needle (10A) according to claim 8,
    The medical needle (10A), wherein the seal member (100) is disposed at a proximal end position in the accommodation space (60) before the needle body (12) is punctured.
  10. [規則91に基づく訂正 28.06.2016] 
     請求項9記載の医療用針(10A)において、
     前記針保持部(14)は、該針保持部(14)の先端部よりも径方向外側に拡径した基端拡径部(104、106)を有し、
     前記シール部材(100)は、前記針体(12)の穿刺前の状態で、前記基端拡径部(104、106)の内側に配置される
     ことを特徴とする医療用針(10A)。
    [Correction 28.06.2016 under Rule 91]
    The medical needle (10A) according to claim 9,
    The needle holding portion (14) has a proximal end diameter-expanded portion (104, 106) that is expanded radially outward from the distal end portion of the needle holding portion (14),
    The medical needle (10A), wherein the seal member (100) is arranged inside the proximal end diameter-enlarged portion (104, 106) before the needle body (12) is punctured.
  11.  請求項8記載の医療用針(10A)において、
     前記シール部材(100)は、前記針体(12)の穿刺前の状態で、前記収容空間(60)内の先端側位置に配置される
     ことを特徴とする医療用針(10A)。
    The medical needle (10A) according to claim 8,
    The medical needle (10A), wherein the seal member (100) is disposed at a distal end side position in the accommodation space (60) in a state before the needle body (12) is punctured.
  12.  請求項1記載の医療用針(10B)において、
     前記プロテクタ(16)は、前記収容空間(60)を構成する収容筒(18)を備え、
     前記収容筒(18)内には、前記針体(12)の穿刺前の状態で、前記遮断部として構成されて前記針保持部(14)に接すると共に、当該収容筒(18)の内周面を全周にわたって封止する弾性体からなる封止部材(54)が設けられる
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 1,
    The protector (16) includes an accommodation cylinder (18) that constitutes the accommodation space (60),
    In the accommodation cylinder (18), the needle body (12) is configured as the blocking section and contacts the needle holding section (14) before being punctured, and the inner circumference of the accommodation cylinder (18). A medical needle (10B), characterized in that a sealing member (54) made of an elastic body that seals the entire surface is provided.
  13.  請求項12記載の医療用針(10B)において、
     前記封止部材(54)は、
     前記収容筒(18)の内周面において、前記針体(12)の穿刺前の状態で、該針体(12)を貫通させ、
     前記針体(12)の穿刺後の状態で、該針体(12)を前記封止部材(54)より基端側の前記収容空間(60)内に配置させる
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 12,
    The sealing member (54)
    In the inner peripheral surface of the storage cylinder (18), the needle body (12) is penetrated in a state before the needle body (12) is punctured,
    A medical needle characterized by disposing the needle body (12) in the accommodation space (60) on the proximal end side with respect to the sealing member (54) in a state after the puncture of the needle body (12). (10B).
  14.  請求項13記載の医療用針(10B)において、
     前記封止部材(54)は、
     前記針体(12)の穿刺前の状態で、前記針体(12)の外周面に接触し、
     さらに、前記収容空間(60)に前記針体(12)を収容した状態で、前記針体(12)の貫通していた部分が内側に狭まる又は閉塞する
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 13,
    The sealing member (54)
    In contact with the outer peripheral surface of the needle body (12) in a state before the puncture of the needle body (12);
    Furthermore, in the state where the needle body (12) is housed in the housing space (60), the portion of the needle body (12) that has passed through narrows or closes inwardly. ).
  15.  請求項14記載の医療用針(10B)において、
     前記プロテクタ(16)は、前記封止部材(54)の配置位置よりも先端側に前記針体(12)から離れた血液を溜めるための血液溜まり部(96)を有する
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 14,
    The protector (16) has a blood reservoir (96) for collecting blood away from the needle body (12) on the distal end side of the position where the sealing member (54) is disposed. Needle (10B).
  16.  請求項12記載の医療用針(10B)において、
     前記封止部材(54)は、前記針体(12)の穿刺前の状態で、前記針保持部(14)の外周面全周にわたって接触している
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 12,
    The medical needle (10B), wherein the sealing member (54) is in contact with the entire outer peripheral surface of the needle holder (14) before the needle body (12) is punctured. .
  17.  請求項12記載の医療用針(10B)において、
     前記封止部材(54)は、前記収容筒(18)とは別部材からなる
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 12,
    The said sealing member (54) consists of a member different from the said storage cylinder (18). The medical needle (10B) characterized by the above-mentioned.
  18.  請求項12記載の医療用針(10B)において、
     前記プロテクタ(16)の先端部には、該先端部の外周面全周にわたって前記針体(12)を覆うキャップ(24)が密着される
     ことを特徴とする医療用針(10B)。
    The medical needle (10B) according to claim 12,
    The medical needle (10B), wherein a cap (24) covering the needle body (12) is brought into close contact with the distal end portion of the protector (16) over the entire outer peripheral surface of the distal end portion.
PCT/JP2016/059286 2015-03-24 2016-03-24 Medical needle WO2016152949A1 (en)

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6088562A (en) * 1983-10-22 1985-05-18 テルモ株式会社 Puncture needle with valve body
US5215525A (en) * 1992-09-29 1993-06-01 Sturman Warren M Safety casing for intravenous catheter needle
JP2002263197A (en) * 2001-03-12 2002-09-17 Medikit Kk Indwelling catheter
JP2004305346A (en) * 2003-04-04 2004-11-04 Jms Co Ltd Medical needle device having winged shield
JP2005230094A (en) * 2004-02-17 2005-09-02 Daikyu:Kk Safe needle with tube
JP2005253613A (en) * 2004-03-10 2005-09-22 Meisei Kyo Retractable medical blood collecting device
WO2007083770A1 (en) * 2006-01-20 2007-07-26 Jms Co., Ltd. Medical needle device
JP2011045532A (en) * 2009-08-27 2011-03-10 Mitsubishi Pencil Co Ltd Indwelling needle syringe
JP2013248222A (en) * 2012-06-01 2013-12-12 Jms Co Ltd Indwelling needle device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6088562A (en) * 1983-10-22 1985-05-18 テルモ株式会社 Puncture needle with valve body
US5215525A (en) * 1992-09-29 1993-06-01 Sturman Warren M Safety casing for intravenous catheter needle
JP2002263197A (en) * 2001-03-12 2002-09-17 Medikit Kk Indwelling catheter
JP2004305346A (en) * 2003-04-04 2004-11-04 Jms Co Ltd Medical needle device having winged shield
JP2005230094A (en) * 2004-02-17 2005-09-02 Daikyu:Kk Safe needle with tube
JP2005253613A (en) * 2004-03-10 2005-09-22 Meisei Kyo Retractable medical blood collecting device
WO2007083770A1 (en) * 2006-01-20 2007-07-26 Jms Co., Ltd. Medical needle device
JP2011045532A (en) * 2009-08-27 2011-03-10 Mitsubishi Pencil Co Ltd Indwelling needle syringe
JP2013248222A (en) * 2012-06-01 2013-12-12 Jms Co Ltd Indwelling needle device

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