WO2020111080A1 - 留置針組立体 - Google Patents
留置針組立体 Download PDFInfo
- Publication number
- WO2020111080A1 WO2020111080A1 PCT/JP2019/046247 JP2019046247W WO2020111080A1 WO 2020111080 A1 WO2020111080 A1 WO 2020111080A1 JP 2019046247 W JP2019046247 W JP 2019046247W WO 2020111080 A1 WO2020111080 A1 WO 2020111080A1
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- WO
- WIPO (PCT)
- Prior art keywords
- housing
- needle hub
- inner needle
- end side
- cap
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3293—Needles; 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 characterised by features of the needle hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
- A61M5/3297—Needles arranged coaxially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1583—Needle extractors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/064—Slit-valve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/0653—Perforated disc
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
Definitions
- the present invention relates to an indwelling needle assembly including an outer needle that is punctured and indwelled when performing infusion, blood collection, hemodialysis, etc., and particularly, an indwelling needle capable of accommodating an inner needle extracted after puncturing It relates to an assembly.
- an indwelling needle assembly has been known as a medical device when performing treatments such as infusion, blood collection, and hemodialysis.
- Examples of such an indwelling needle assembly include those described in JP-A-2015-47493 (Patent Document 1).
- the indwelling needle assembly described in Patent Document 1 has a structure in which an inner needle and an outer needle are inserted into and out of each other. After the inner and outer needles are punctured into a blood vessel of a patient, the inner needle is pulled out from the outer needle. Therefore, the outer needle is left in the blood vessel of the patient and used for treatment.
- the biasing force of the biasing member housed in the housing is used. That is, in the state before the indwelling needle assembly is punctured, the operating member provided on the outer peripheral surface of the housing and the inner needle hub that fixes and supports the inner needle are engaged, and the inner needle is urged by the urging force of the urging member. It is maintained in a protruding state from the housing against. Then, after the puncture, by depressing the operation member, the engagement between the operation member and the inner needle hub is released, and the inner needle moves in the direction of being pulled out from the outer needle according to the urging force of the urging member. It is adapted to be housed in a housing.
- the present invention may have a problem to be solved by providing an indwelling needle assembly having a novel structure in which an impact sound when an inner needle is housed in a housing is quiet.
- the inner needle is inserted into the outer needle projectingly arranged on the distal end side of the housing, and the operation member provided on the outer peripheral surface of the housing is pushed down.
- a depressing needle assembly in which the inner needle is housed in the housing by a biasing member, and a pushing operation direction of the operating member in a delivery operation section exerted an operating force for delivering the outer needle from the housing to a distal end side.
- a positioning mechanism for positioning in the direction is provided.
- the sliding operation of the inner needle by the operating member can be blocked by the lock portion until the outer needle is generally sent out after the puncture. Therefore, it is possible to prevent the inner needle from being housed in the housing by, for example, unintentionally pushing down the operating member before puncturing.
- the operation of sending out the outer needle, which is generally performed after puncture is skillfully used to release the blocking by the lock part, so no special operation for releasing the lock is required and good operability is demonstrated. Can be done.
- the delivery operating portion is positioned in the circumferential direction with respect to the operating member, so that careless rotation of the delivery operating portion can be prevented.
- the operation can be performed more stably.
- a second aspect of the present invention is the indwelling needle assembly according to the first aspect, wherein the delivery operating portion is formed by an outer needle hub provided on the proximal end side of the outer needle. ..
- the outer needle hub included in the outer needle can be directly fed out and operated.
- a third aspect of the present invention is the indwelling needle assembly according to the first aspect, wherein the delivery operating portion is arranged between an outer needle hub provided on the proximal side of the outer needle and the housing. It is composed of a slider.
- the outer needle can be fed out by operating the slider, and for example, the feeding operation can be performed while avoiding contact with the outer needle including the outer needle hub.
- the feeding operation can be performed while avoiding contact with the outer needle including the outer needle hub.
- the outer needle can be pushed out without touching the outer needle hub with fingers, contamination of the outer needle hub due to undesired contact can be prevented.
- the delivery operation portion is coaxially positioned with respect to the housing, and the delivery operation portion is delivered to the distal end side.
- a supporting mechanism for allowing the lock is provided, and the lock portion is configured by a contact structure of the operating member and the delivery operating portion in a direction perpendicular to the axis of the housing.
- the support mechanism realizes the coaxial delivery of the delivery operation part to the housing.
- a lock portion that prevents the pressing operation of the operation member can be configured by utilizing the positioning state of the delivery operation portion by the support mechanism.
- a fifth aspect of the present invention is the indwelling needle assembly according to any one of the first to fourth aspects, wherein the positioning mechanism is arranged in the circumferential direction of the housing in the operating member and the delivery operating portion.
- the contact structure is configured.
- positioning of the delivery operation portion with respect to the operation member in the circumferential direction of the housing is realized by the direct abutting action of the operation member and the delivery operation portion.
- a sixth aspect of the present invention is the indwelling needle assembly according to any one of the first to fifth aspects, wherein one of the operating member and the delivery operating portion has a positioning recess opening toward the other.
- a positioning projection is provided on the other side of the operation member and the delivery operation section, the positioning projection protruding toward one side, and the positioning projection is inserted into the positioning recess, and
- the locking projection and the positioning mechanism are configured by the positioning projection being separated from the positioning recess by sending out the outer needle by the sending operation part.
- the positioning concave portion and the positioning convex portion that are detached when the outer needle is fed out are fitted into the concave and convex portions to prevent the pressing operation of the operating member, and the operating member.
- a circumferential positioning mechanism for the delivery manipulator may be configured.
- an operation force for sending the outer needle from the housing to the distal end side is directly applied to the sending operation section.
- the projecting piece for delivery that can extend to the above is provided so as to project on the outer periphery at a position corresponding to the operating member of the housing in the circumferential direction.
- the indwelling needle assembly having the structure according to the present aspect, it is easy to use both the operating member and the delivery projection piece toward a position that is easy to operate on the side opposite to the body surface of the patient during puncture. Become.
- An eighth aspect of the present invention is the indwelling needle assembly according to any one of the first to seventh aspects, wherein the inner needle hub provided on the proximal end side of the inner needle is a base member by the biasing member.
- the urging member is arranged so as to be biased toward the end side and is disposed in the housing, and the distal end side of the operating member in the pressing direction is projected into the housing and engages with the inner needle hub, thereby the An engagement portion is provided to prevent the inner needle hub from moving, and the movement of the operating member in the pressing direction causes the engagement portion to move outwardly of the housing to engage with the inner needle hub. It is supposed to be released.
- the operating member is released from the direct engagement state with the inner needle hub along with the pressing operation of the operating member, whereby the inner needle is released from the protruding state. It can be switched to the state of being housed in the housing by the biasing means.
- an inner needle is inserted through an outer needle projectingly arranged on the distal end side of the housing, and an operation member provided on the outer peripheral surface of the housing is pressed to operate.
- An indwelling needle assembly in which the inner needle is housed in the housing by a biasing member, the inner needle having an inner needle hub on the proximal side, and a cap on the proximal side of the housing.
- a proximal end of the inner needle by the urging member when the inner needle is accommodated in the housing is defined by abutting of the inner needle hub to the cap, At least one of the following (1) to (10) is adopted as a mechanism for reducing the hitting sound of the inner needle hub to the cap.
- the inner needle hub and the inner needle hub are configured so that the contact force of the inner needle hub with the cap is gradually increased by forming the cylindrical inner peripheral surface of the inner needle hub as an inclined surface that reduces in diameter rearward.
- the inner needle hub and the cap are configured so that the contact portion with the cap is formed in a substantially linear shape extending in the circumferential direction and the width dimension of the contact surface is reduced to avoid a large hitting sound due to flat contact.
- the cushioning effect due to the deformation of the contact portion and/or the tapping sound reducing effect by reducing the contact area is exhibited.
- the inner peripheral surface of the inner needle hub that abuts the cap gradually expands toward the cap side and/or the outer periphery that gradually tapers toward the cap side.
- a structure in which rigidity is reduced by the surface, and a cushioning action is exerted by hitting deformation at a contact portion of the inner needle hub with the cap. Is provided so that the tubular protrusion is fitted into the proximal end opening of the housing body, and the proximal end of the inner needle hub is inserted into the tubular protrusion.
- a coil spring is adopted as the urging member, and the natural length of the coil spring is set to be smaller than the axial movement distance of the inner needle hub. And the effect of reducing the hitting sound by the tensile force of the coil spring when hitting the cap.
- a hemostatic valve is assembled to an outer needle hub provided on the proximal end side of the outer needle, and the inner needle is disposed so as to penetrate the hemostatic valve. A compression force is exerted on the outer peripheral surface of the hemostatic valve, and the hemostatic valve applies a biasing force to the inner needle by the compression force.
- the indwelling needle assembly having the structure according to the first to eighth aspects of the present invention, an unintended accommodation operation of the inner needle into the housing by the operating member before the feeding operation of the outer needle is prevented. Further, the careless rotation of the sending operation unit can be prevented, and the workability of the sending operation of the sending operation unit can be improved, for example. Further, in the ninth aspect of the present invention, it is possible to suppress the operating noise when the inner needle is housed in the housing after the puncture, and the first to eighth basic configurations that make the presumed basic configuration substantially the same. It is also preferable to employ it in combination with the embodiment.
- FIG. 2 is a vertical sectional view of the indwelling needle assembly shown in FIG. 1.
- FIG. 3 is a vertical cross-sectional view showing an enlarged main part in FIG. 2. 1.
- FIG. 5 is a vertical cross-sectional perspective view of the operation button shown in FIG. 4.
- FIG. 3 is a perspective view showing a state in which the outer needle hub is pushed forward in the puncturing direction after puncturing in the indwelling needle assembly shown in FIG. 1.
- FIG. 2 is an enlarged vertical cross-sectional view showing a main part of the indwelling needle assembly shown in FIG.
- FIG. 1 in a state where an operation button is pushed down, showing a state before an inner needle moves into a housing.
- FIG. 2 is a vertical cross-sectional view showing a state in which an operation button is pushed down in the indwelling needle assembly shown in FIG. 1 to accommodate an inner needle in a housing.
- the perspective view which shows the indwelling needle assembly as the 2nd Embodiment of this invention in an initial state.
- the longitudinal cross-sectional view which expands and shows the principal part of the indwelling needle assembly shown in FIG.
- FIG. 12 is a vertical cross-sectional perspective view of the operation button shown in FIG. 11.
- FIG. 10 is a perspective view showing a state where the slider is pushed forward in the puncturing direction after puncturing in the indwelling needle assembly shown in FIG. 9.
- FIG. 10 is a vertical cross-sectional view showing a state in which the operation button is pushed down in the indwelling needle assembly shown in FIG. 9 to accommodate the inner needle in the housing.
- FIGS. 1 to 3 show an indwelling needle assembly 10 according to a first embodiment of the present invention in an initial state (state before puncturing).
- the indwelling needle assembly 10 includes an outer needle unit 12 and an inner needle unit 14. That is, the outer needle unit 12 is configured to include the outer needle 16 and the outer needle hub 18 as a delivery operation portion provided on the proximal end side of the outer needle 16.
- the inner needle unit 14 supports the inner needle 22 having the needle tip 20 at the tip, the inner needle hub 24 provided on the proximal end side of the inner needle 22, and the inner needle 22 and the inner needle hub 24.
- the housing 26 is included.
- the indwelling needle assembly 10 is configured by inserting the inner needle 22 of the inner needle unit 14 into the outer needle unit 12 from the base end side. After the indwelling needle assembly 10 is punctured, the inner needle 22 is pulled out from the outer needle 16 by depressing the operation button 28 as an operation member that is exposed and provided on the outer peripheral surface 27 of the housing 26.
- the outer needle unit 12 is adapted to be indwelled on the skin of the patient while being moved to and housed in the inside of 26.
- the axial direction means the left-right direction in FIG. 2 which is the needle axis direction of the outer needle 16 and the inner needle 22.
- the tip side means the left side in FIG. 2 that is the needle tip 20 side of the inner needle 22, while the base end side means the right side in FIG. 2 that is the side operated by the user.
- the upward direction and the downward direction refer to the upward direction and the downward direction in FIG. 2, respectively.
- the outer needle 16 has a tube shape and is made of a material having appropriate flexibility, for example, ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, polyether nylon resin. It is made of various soft resins such as.
- ETFE ethylene-tetrafluoroethylene copolymer
- the outer peripheral surface of the tip portion of the outer needle 16 is a tapered outer peripheral surface 30, which can reduce puncture resistance to the living body. Further, by providing a through hole in the peripheral wall of the tip portion of the outer needle 16, it is possible to improve the flow efficiency of the fluid with respect to the outer needle 16.
- the outer needle hub 18 provided on the proximal end side of the outer needle 16 is made of a hard synthetic resin material such as polypropylene and has a substantially cylindrical shape having a peripheral wall portion 32 extending in the axial direction as a whole.
- the peripheral wall portion 32 of the present embodiment has a substantially cylindrical shape with steps, and both the inner diameter dimension and the outer diameter dimension are smaller on the distal end side than on the proximal end side. Then, the proximal end of the outer needle 16 is inserted into the small-diameter tip side portion, and processing such as adhesion is performed as necessary, so that the proximal end of the outer needle 16 is attached to the outer needle hub 18. It is fixedly supported.
- the large-diameter base end side portions are each formed into a tapered surface shape in which the diameter gradually increases toward the base end side as a whole.
- a substantially annular flange portion 40 projecting to the outer peripheral side is provided at the proximal end side opening portion 38 on the outer peripheral surface 36 of the outer needle hub 18, and a male screw is formed on the outer peripheral surface of the flange portion 40.
- a luer lock type syringe or the like can be connected to the proximal end side opening portion 38 of the outer needle hub 18. Is becoming
- the flange portion 40 is provided with a lock groove 42 as a positioning recess extending in the axial direction in a part of the circumference (upper side in FIG. 2).
- the lock groove 42 is opened to the outer peripheral side (upper side) and is formed over the entire length in the thickness direction (axial direction) of the flange portion 40, and the front end side and the base end side of the flange portion 40 are formed. It is open to the end face.
- the groove depth dimension (radial dimension) of the lock groove 42 is substantially equal to the protrusion dimension of the flange portion 40 from the outer peripheral surface 36 of the outer needle hub 18.
- the flange portion 40 is divided in the circumferential direction by the lock groove 42, and both circumferential direction side portions 42a, 42a of the flange portion 40 that sandwich the lock groove 42 face each other with a predetermined distance. ..
- a positioning groove 44 that extends in the axial direction is provided on the side opposite to the lock groove 42 in the radial direction.
- the positioning groove 44 is also open to the outer peripheral side (downward) and is formed over the entire length of the flange portion 40 in the thickness direction (axial direction). It is open to the side edges.
- the groove depth dimension (radial dimension) of the positioning groove 44 is substantially equal to the projecting dimension of the flange portion 40 from the outer peripheral surface 36 of the outer needle hub 18, and in short, the flange portion 40 is positioned.
- the groove 44 is also divided in the circumferential direction.
- an operation piece 46 is provided at a part of the circumference (upper side in FIG. 2) as a projecting piece for delivery protruding to the outer peripheral side (upper side).
- the operation piece 46 is formed into a substantially rectangular plate shape having a predetermined width dimension, and after the indwelling needle assembly 10 is punctured, the user puts his/her finger on the operation piece 46 and the outer needle hub. 18 is sent out forward (the tip side) in the puncturing direction. That is, when the outer needle hub 18 is delivered to the distal end side, an operating force for delivering the outer needle hub 18 to the distal end side is directly applied to the operation piece 46.
- a positioning protrusion 47 for the hemostatic valve mechanism is provided at an axially intermediate portion of the inner peripheral surface 34 of the outer needle hub 18 so as to protrude toward the inner peripheral side.
- the four positioning protrusions 47, 47, 47, 47 are formed on the circumference at substantially equal intervals.
- a hemostatic valve mechanism 48 is housed inside the outer needle hub 18.
- the hemostatic valve mechanism 48 includes a hemostatic valve 50, a pusher 52, and a pusher guide 54.
- the hemostasis valve 50 is a disc valve having a slit 56 formed in the center, and is made of an elastic rubber elastic body or elastomer.
- the shape of the slit 56 is not limited to a single letter shape or a cross shape, but in the present embodiment, it is a radial shape extending from the center in three circumferential directions at substantially equal intervals (every 120°). Has been done.
- the pusher 52 has a substantially tubular shape as a whole, and the inner diameter dimension is larger than the outer diameter dimension of the inner needle 22.
- the pusher guide 54 has a substantially tubular shape as a whole, and the inner diameter dimension is substantially equal to or slightly larger than the maximum outer diameter dimension at the tip portion of the pusher 52, while the outer diameter dimension is the outer needle.
- the inner diameter of the hub 18 is made substantially equal.
- An annular groove 58 that opens to the outer peripheral side is formed on the outer peripheral surface of the pusher guide 54.
- the hemostasis valve 50 has an outer diameter dimension slightly larger than an inner diameter dimension of the peripheral wall portion 32 of the outer needle hub 18 in a single state before being assembled to the outer needle hub 18.
- the hemostatic valve 50 is compressed in the radial direction (for example, the vertical direction in FIG. 2) and is housed and arranged in the outer needle hub 18 with the slit 56 closed.
- a pusher 52 and a pusher guide 54 are positioned inside and outside of the hemostatic valve 50 on the proximal end side.
- the pusher guide 54 is disposed between the pusher 52 and the outer needle hub 18 in the radial direction, and the positioning protrusion 47 of the outer needle hub 18 and the annular recessed groove 58 of the pusher guide 54 are mutually disposed.
- the pusher guide 54 is assembled to the outer needle hub 18 by fitting the protrusions and recesses together. Further, the outer peripheral surface at the tip portion of the pusher 52 is substantially in contact with the inner peripheral surface of the pusher guide 54, and the pusher 52 slides in the length direction (axial direction) with respect to the pusher guide 54. It is supposed to be movable. Further, in this embodiment, in the initial state, the distal end surfaces of the pusher 52 and the pusher guide 54 are positioned in contact with the base end surface of the hemostatic valve 50.
- the inner needle 22 is inserted into the hemostasis valve 50, and as described later, after the indwelling needle assembly 10 is punctured, the inner needle 22 is moved to the proximal end side. As a result, the slit 56 of the hemostasis valve 50 is closed.
- a male luer such as a syringe is inserted from the proximal end side opening portion 38 of the outer needle hub 18, so that the tip of the male luer causes the pusher 52 to tip.
- the pusher 52 When the pusher 52 is pushed in the direction, and the pusher 52 is guided by the pusher guide 54 to move to the distal end side, the slit 56 of the hemostatic valve 50 is opened.
- the inside of the outer needle 16 and the inside of the outer needle hub 18 (the inside of the pusher 52) communicate with the inside of the syringe or the like, and, for example, the drug solution in the syringe is introduced into the blood vessel of the patient through the outer needle unit 12. It is supposed to be injected.
- the pusher 52 is pushed back to the initial position by the elastic restoring action of the hemostatic valve 50, and the slit 56 is promptly released. It is supposed to be closed.
- the inner needle 22 in the inner needle unit 14 is a hollow needle having a sharpened needle tip 20, and is made of a known material such as stainless steel, aluminum, titanium or alloys thereof. That is, the needle tip 20 of the inner needle 22 is formed with a blade surface 60 that spreads in a direction inclined with respect to the axial direction, so that the inner needle 22 can be easily punctured into the skin of a patient or the like. Is becoming In this embodiment, the blade surface 60 faces upward.
- the inner needle 22 may be a solid needle.
- the outer diameter dimension of the inner needle 22 is smaller than the inner diameter dimension of the outer needle 16, and when the inner needle 22 and the outer needle 16 are inserted in and out, the radial distance between the inner needle 22 and the outer needle 16 is increased.
- An annular gap 62 is formed in the. That is, the radial gap 62 between the inner needle 22 and the outer needle 16 communicates with the inner space of the outer needle hub 18.
- the distal end portion of the inner needle 22 is provided with a through hole 63 that penetrates the peripheral wall of the inner needle 22, so that the blood that has flowed into the inner needle 22 when the indwelling needle assembly 10 is punctured is penetrated.
- the inner needle hub 24 provided on the proximal end side of the inner needle 22 is made of a hard synthetic resin material such as polypropylene and has a generally long, substantially cylindrical shape.
- An annular step surface 64 is formed on the inner peripheral surface of the inner needle hub 24, and a tip end side of the step surface 64 is a small diameter portion 66 having a small inner diameter dimension, and the base is more than the step surface 64.
- the end side is a large diameter portion 68 having a larger inner diameter than the small diameter portion 66.
- the inner diameter of the small-diameter portion 66 is substantially equal to or slightly larger than the outer diameter of the inner needle 22, and the base end of the inner needle 22 is inserted into the small-diameter portion 66, and as necessary.
- the base end of the inner needle 22 is fixed to the small-diameter portion 66 by performing a process such as bonding, and thus the base end of the inner needle 22 is fixedly supported by the inner needle hub 24.
- the outer diameters of the small-diameter portion 66 and the large-diameter portion 68 are substantially equal to each other, and the outer peripheral surface of the small-diameter portion 66 and the outer peripheral surface of the large-diameter portion 68 do not have a step in the axial direction. Are continuous with each other.
- the tip portion of the small diameter portion 66 has a tapered shape that substantially corresponds to the base end side opening portion 38 of the outer needle hub 18, and as will be described later, the tip portion of the small diameter portion 66 (the insertion portion 124).
- the outer diameter dimension of the tip portion of the small diameter portion 66 may be smaller than the inner diameter dimension of the proximal end side opening portion 38 of the outer needle hub 18, and the inner peripheral surface of the outer needle hub 18 and the tip portion of the small diameter portion 66.
- a gap may be formed between the outer peripheral surface of the (insertion portion 124).
- the proximal end opening of the inner needle hub 24 (that is, the proximal end opening of the large-diameter portion 68) is provided with a filter that does not allow passage of liquid but allows passage of gas.
- a filter that does not allow passage of liquid but allows passage of gas.
- the outer peripheral surface of the inner needle hub 24 is provided with a guide groove 70 (see FIG. 6 etc.) that extends over the entire length in the axial direction and opens to the outer peripheral side.
- the guide grooves 70 have a substantially rectangular cross-sectional shape, and four guide grooves 70, 70, 70, 70 are formed on the outer peripheral surface of the inner needle hub 24 at substantially equal intervals on the circumference. Has been done.
- a substantially annular flange-shaped portion 72 projecting to the outer peripheral side is formed at the base end side opening portion (that is, the base end side opening portion of the large diameter portion 68). ..
- concave grooves (not shown) that extend in the axial direction and open to the outer peripheral side are provided at positions corresponding to the four guide concave grooves 70, 70, 70, 70. ing.
- the guide concave grooves 70, 70, 70, 70 provided on the outer peripheral surface of the inner needle hub 24 are also formed over the flange-shaped portion 72, and the flange-shaped portion 72 is divided in the circumferential direction. It has a shape.
- a tapered surface 73 having a diameter that gradually decreases toward the base end side is provided at the base end on the outer peripheral surface of the flange-shaped portion 72. Further, the inner peripheral surface of the base end side opening portion of the inner needle hub 24 is also tapered so as to expand toward the base end side, and the base end of the inner needle hub 24 is tapered and thin. The rigidity is reduced by.
- an engaging recess 74 that opens to the outer peripheral side is formed in the axially intermediate portion (that is, the axially intermediate portion of the small diameter portion 66).
- the engagement recess 74 is formed in a part of the circumference (downward in FIG. 2), and is open downward in the present embodiment.
- the inner needle hub 24 having such a structure is supported by the housing 26. That is, the housing 26 has a substantially bottomed tubular shape as a whole, and the inner needle hub 24 is arranged inside the housing 26.
- the housing 26 is made of the same hard synthetic resin as the outer needle hub 18 and the inner needle hub 24. Further, the housing 26 is configured to include a substantially tubular housing body 76 and a cap 80 that closes a base end side opening 78 of the housing body 76.
- the cap 80 is provided with an annular protruding portion 81 that protrudes toward the tip side from the substantially disk-shaped main body portion as a whole, and is integrally formed of an elastic body such as rubber or elastomer.
- the inner peripheral surface of the protruding portion 81 has an inclined surface 82 having a larger diameter toward the tip side.
- the protruding portion 81 is fitted into the base end side opening 78 of the housing body 76, and the outer peripheral end of the body portion and the outer peripheral surface of the protruding portion 81 are axially end surface and inner peripheral surface of the housing body 76 as required.
- the cap 80 is fixed to the base end side opening 78 of the housing main body 76 by being welded or adhered thereto.
- the cap 80 may not be fixed to the base end side opening 78 of the housing body 76.
- the cap 80 may extend over the entire circumferential direction or partially in the circumferential direction.
- the projections 83 having a tapered cross section, such as a substantially semicircular shape, may be provided.
- the projections 83 are press-fitted into the base end side opening 78 of the housing body 76, so that the cap 80 can be press-fitted and fixed without being bonded. It should be noted that such a press-fitting fitting projection may be provided on the inner peripheral surface of the base end side opening 78 of the housing body 76.
- a through hole 84 penetrating in the thickness direction is formed in the central portion of the cap 80, and when the inner needle hub 24 moves inside the housing 26, the air inside the housing 26 is It is adapted to be discharged to the outside through the through hole 84. This can reduce the possibility that the movement of the inner needle hub 24 is hindered by the action of the air spring caused by the air inside the housing 26.
- the housing main body 76 of the present embodiment includes a cylindrical peripheral wall portion 86 having an axial dimension larger than the axial dimension from the needle tip 20 of the inner needle 22 to the base end of the inner needle hub 24.
- the inner diameter of the peripheral wall portion 86 is substantially constant over substantially the entire length in the axial direction, and is slightly larger than the outer diameter dimension of the flange-shaped portion 72 at the base end of the inner needle hub 24.
- the inner diameter of the peripheral wall portion 86 is smaller than the other portions, and is smaller than the outer diameter of the flange-shaped portion 72 of the inner needle hub 24.
- the outer diameter dimension of the portion (small diameter portion 66 and large diameter portion 68) other than the flange-shaped portion 72 is approximately equal to or slightly larger than the outer diameter dimension.
- the inner needle hub 24 arranged in the housing 26 is movable in the housing 26 in the axial direction, and can be prevented from falling out of the housing 26 through the distal end side opening 88.
- the inner diameter dimension of the distal end side opening portion 88 of the housing body 76 is made substantially equal to the inner diameter dimension of the proximal end side opening portion 38 of the outer needle hub 18.
- An insertion hole 90 penetrating in the vertical direction is formed at the tip of the peripheral wall portion 86.
- the insertion hole 90 has a substantially rectangular shape in a plan view, and the dimension in the width direction (the dimension in the direction orthogonal to the paper surface in FIG. 2) is larger than the dimension in the axial direction.
- the widthwise dimension of the insertion hole 90 is smaller than the widthwise dimension (outer diameter dimension) of the peripheral wall portion 86, and the insertion hole 90 penetrates the upper portion and the lower portion of the cylindrical peripheral wall portion 86,
- the outer peripheral surface 27 of the housing 26 is open at the upper side and the lower side.
- a fitting groove 94 extending in the axial direction is formed on a part of the outer circumference surface (upper side in FIG. 2) of the outer peripheral surface 27 of the front end side opening portion 88 of the housing 26 (housing main body 76).
- the fitting groove 94 is provided on the upper side of the housing main body 76 on the tip side of the insertion hole 90 and communicates with the insertion hole 90.
- the groove width dimension of the fitting groove 94 (dimension in the direction orthogonal to the paper surface in FIG. 2) is substantially equal to the groove width dimension of the lock groove 42 provided in the flange portion 40 of the outer needle hub 18. That is, the circumferential side (width direction) side portions 94a, 94a sandwiching the fitting groove 94 in the peripheral wall portion 86 face each other with a predetermined distance therebetween.
- a part of the circumference is formed with a surrounding projection 96 protruding toward the outer peripheral side (upper side).
- the surrounding protrusion 96 extends in a substantially U-shape or a substantially U-shape with a substantially triangular vertical cross section, and is open to the tip side.
- the surrounding projection 96 is provided on the proximal side of the insertion hole 90, and the front end side opening of the surrounding projection 96 communicates with the insertion hole 90. That is, the region surrounded by the surrounding protrusion 96 is an arrangement region 98 that is recessed upward with respect to the surrounding protrusion 96.
- the bottom surface of the disposition region 98 that is, the portion 27a of the outer peripheral surface 27 of the housing 26 surrounded by the surrounding protrusions 96 is located on the inner peripheral side of the other portion of the outer peripheral surface 27. Therefore, a large vertical dimension of the arrangement area 98 is ensured. Further, by providing the portion 27a surrounded by the surrounding protrusion 96 on the inner peripheral side of the other portion of the outer peripheral surface 27, it is possible to relatively increase the protrusion height of the surrounding protrusion 96. Further, the surrounding guide portion 96 can more effectively exert the vertical guiding action when the operation button 28 is pressed.
- a positioning protrusion 100 projecting to the tip side is formed on the side opposite to the fitting groove 94 in the radial direction.
- the positioning protrusion 100 has a substantially rectangular shape in a plan view, and the dimension of the positioning protrusion 100 in the width direction is substantially equal to the dimension of the positioning groove 44 provided in the flange portion 40 of the outer needle hub 18 in the width direction. Or it is slightly smaller.
- the inner peripheral surface 102 of the housing main body 76 is formed with a guide protrusion 104 protruding from the peripheral wall portion 86 toward the inner peripheral side.
- the guide protrusion 104 has a substantially rectangular cross-sectional shape, and is formed over the entire axial length on the base wall side of the peripheral wall portion 86 with respect to the insertion hole 90.
- the guide protrusions 104 are formed at four locations on the circumference at circumferential positions corresponding to the grooves (guide grooves 70) provided on the outer peripheral surface of the flange-shaped portion 72 of the inner needle hub 24. Has been done.
- the inward protrusions 106, 106 having a large protrusion size toward the inner peripheral side. , 106, 106 are formed.
- the numbers of the guide protrusions 104, the grooves (the guide grooves 70), and the inward projections 106 are not limited, and may be three or five or more, for example.
- the operation button 28 as shown in FIGS. 4 and 5 is assembled to the housing 26 having the above structure.
- the operation button 28 is formed of the same hard synthetic resin as the housing 26, and has a base portion 108 having the same shape as the area (arrangement area 98) surrounded by the surrounding protrusion 96 in a plan view. I have it.
- the upper surface 110a of the base portion 108 is a curved surface that is convex upward, while the lower surface 110b is a flat surface that extends in the axial direction.
- the upper surface 110a of the base portion 108 is a curved surface, a large contact area with the user's finger is secured when the operation button 28 is pressed, and the operability of the pressing operation is improved. Can be achieved.
- annular portion 112 protruding downward is formed at the tip of the base portion 108. That is, the outer shape of the annular portion 112 is a substantially rectangular plate shape whose vertical dimension is larger than its widthwise dimension when viewed in the axial direction, while a substantially circular inner hole 114 is formed in the center. It is formed so as to penetrate in the thickness direction (axial direction).
- the upper portion of the annular portion 112 is formed integrally with the base portion 108.
- the inner diameter of the annular portion 112 (the inner diameter of the inner hole 114) is approximately the same as the inner diameter of the peripheral wall portion 86 of the housing body 76 (the inner diameter of the tip opening 88 other than the portion having the smaller inner diameter). Have been made equal.
- the axial dimension and the width dimension of the annular portion 112 are substantially equal to or slightly smaller than the axial dimension and the width dimension of the insertion hole 90 in the peripheral wall portion 86 of the housing body 76, respectively.
- annular portion 112 on the side opposite to the side on which the base portion 108 is provided in the radial direction (that is, on the lower side which is the tip side in the pressing direction of the operation button 28), the inner peripheral side (upward) is projected.
- An engagement protrusion 116 is provided as an engagement portion. That is, the inner diameter of the annular portion 112 is reduced at the formation position of the engagement protrusion 116, and the inner diameter dimension at the formation position of the engagement protrusion 116, that is, the vertical direction of the base 108 and the engagement protrusion 116.
- the separation distance is substantially equal to the inner diameter dimension of the front end side opening portion 88 in the housing body 76.
- a lock protrusion 118 serving as a positioning protrusion protruding toward the tip side is provided in the central portion of the base portion 108 in the width direction (direction orthogonal to the paper surface in FIG. 2), and the tip of the lock protrusion 118 is provided. Is an abutting portion 120 that bends and projects toward the inner peripheral side (downward).
- the widthwise dimension of the lock protrusion 118 is substantially the same as the groove width dimension of the fitting groove 94 provided in the distal end side opening 88 of the housing body 76 and the lock groove 42 provided in the flange portion 40 of the outer needle hub 18. Equal to or slightly smaller.
- the inner needle unit 14 is configured to include the inner needle 22, the inner needle hub 24, the housing 26, and the operation button 28 having the above-described structure. That is, the inner needle 22 is fixed to the inner needle hub 24, and the inner needle 22 and the inner needle hub 24 are inserted from the base end side opening 78 of the housing body 76, and the base end side opening 78 is capped.
- the inner needle hub 24 is accommodated and arranged in the housing 26 by being closed by 80.
- the guide protrusion 104 provided on the inner peripheral surface 102 of the housing body 76 is provided in the groove provided in the flange portion 72 of the inner needle hub 24.
- the inward projection 106 provided at the tip of the guide projection 104 is inserted into the guide groove 70 provided on the outer peripheral surface of the inner needle hub 24.
- the inner needle hub 24, and the housing 26 in the circumferential direction is prevented, and the blade surface 60 of the inner needle 22 and the operation button 28 are aligned in the circumferential position. And both are directed upwards.
- operation buttons 28 are attached to the housing 26. That is, the annular portion 112 of the operation button 28 is inserted from above into the insertion hole 90 provided at the distal end portion of the housing body 76, and with respect to the arrangement area 98 surrounded by the surrounding protrusion 96.
- the base portion 108 is accommodated and arranged. That is, in the present embodiment, the operation button 28 is exposed and arranged in the arrangement area 98 provided on the outer peripheral surface 27 of the housing 26 (housing main body 76), and the operation button 28 is positioned above the housing 26. is doing.
- the operation button 28 can be moved in the vertical direction with respect to the housing 26. ..
- the lock protrusion 118 protruding from the base portion 108 to the tip side is located on the outer peripheral side (upper side) of the fitting groove 94 provided in the tip side opening 88 of the housing body 76.
- the circumference of the housing 26 and the operation button 28 can be reduced. Relative rotation of directions is prevented. That is, among the wall portions forming the annular portion 112, the wall portions 112a, 112a on both sides in the width direction that sandwich the inner hole 114 are the wall portions 86a on both sides in the width direction that sandwich the insertion hole 90 in the peripheral wall portion 86 of the housing body 76. , 86a, the relative rotation of the housing 26 and the operation button 28 in the circumferential direction is prevented.
- the relative rotation of the housing 26 and the operation button 28 in the circumferential direction is prevented by the contact of the base 108 with the surrounding protrusion 96.
- the relative rotation preventing mechanism for the housing 26 and the operation button 28 either the annular portion 112 is inserted into the insertion hole 90 or the base portion 108 is accommodated and arranged in the arrangement area 98. It may be configured by only one of them.
- the inner needle 22 and the inner needle hub 24 are inserted into the inner hole 114 of the annular portion 112 inserted into the insertion hole 90, and the engaging convex portion provided below the annular portion 112. 116 is fitted into and engaged with an engagement recess 74 that is opened in the lower surface of the inner needle hub 24.
- the tip portions of the inner needle 22 and the inner needle hub 24 are held in a state of protruding from the housing 26 toward the tip side.
- the engaging convex portion 116 protrudes toward the inner peripheral side, and the engaging convex portion 116 and the engaging concave portion 74 of the inner needle hub 24 engage with each other, so that the housing 26 Axial movement of the inner needle hub 24 is prevented.
- a coil spring 122 as a biasing member is arranged between the inner needle hub 24 and the housing 26. That is, the coil spring is axially provided between the flange portion 72 provided at the base end of the inner needle hub 24 and the inward projections 106, 106, 106, 106 projecting toward the inner peripheral side at the distal end portion of the housing 26. 122 is provided. In the initial state, the flange-like portion 72 and the inward protrusions 106, 106, 106, 106 are in a state of being close to each other, and the coil spring 122 is formed by the flange-like portion 72 and the inward protrusion 106. It is compressed.
- the inner needle hub 24 is urged by the elastic restoring force of the coil spring 122 toward the base end side of the housing 26.
- the movement of the inner needle hub 24 toward the base end side of the housing 26 due to the urging force is blocked by the engagement between the engagement protrusion 116 and the engagement recess 74.
- the indwelling needle assembly 10 of this embodiment is configured by assembling the outer needle unit 12 with the inner needle unit 14 having such a structure. That is, the inner needle 22 is inserted through the proximal end opening 38 of the outer needle hub 18, penetrates the hemostatic valve mechanism 48 and the outer needle 16, and the needle tip 20 of the inner needle 22 projects from the outer needle 16. There is.
- the hemostatic valve 50 is radially compressed by the peripheral wall portion 32 of the outer needle hub 18, the hemostatic valve 50 is inserted by inserting the inner needle 22 into the slit 56 of the hemostatic valve 50.
- a radial compression force of 50 is exerted on the inner needle 22.
- the hemostatic valve 50 applies a biasing force to the inner needle 22 by the compressive force of the hemostatic valve 50, and the inner surface of the slit 56 is pressed against the outer peripheral surface of the inner needle 22.
- the distal end portion of the inner needle hub 24 enters the inside of the outer needle hub 18 through the base end side opening 38 of the outer needle hub 18.
- the distal end portion of the inner needle hub 24 serves as an insertion portion 124 that enters the inside from the proximal end side opening 38 of the outer needle hub 18.
- the outer diameter of the tip portion (small diameter portion 66) of the inner needle hub 24 is set to be substantially equal to the inner diameter of the base end side opening 38 of the outer needle hub 18, so that the insertion portion The outer peripheral surface of 124 and the inner peripheral surface 34 of the outer needle hub 18 come into contact with each other without a gap.
- a gap may be formed between the outer peripheral surface of the insertion portion 124 and the inner peripheral surface 34 of the outer needle hub 18.
- the distal end opening 88 of the housing 26 (housing main body 76) is axially adjacent to the proximal end opening 38 of the outer needle hub 18, in other words, the distal end of the housing 26.
- the outer needle hub 18 is located on the side.
- the lock projection 118 protruding from the base portion 108 to the distal end side of the operation button 28 extends to the outer peripheral side of the flange portion 40 of the outer needle hub 18.
- the contact portion 120 which is the front end portion of the lock protrusion 118, is inserted into the lock groove 42 provided in the flange portion 40 of the outer needle hub 18 from the outer peripheral side (above). That is, the abutment portion 120 of the lock protrusion 118 abuts circumferentially on both sides 42a, 42a of the flange portion 40 that sandwich the lock groove 42, whereby the operation button 28 and the outer needle hub 18, that is, the inner needle hub.
- one of the positioning mechanisms for positioning the outer needle hub 18 with respect to the operation button 28 in the circumferential direction is configured to include the lock protrusion 118 and the lock groove 42.
- the positioning protrusion 100 provided on the inner needle unit 14 on the side opposite to the locking projection 118 in the radial direction is provided with the flange portion 40 of the outer needle hub 18. It is inserted into the positioning groove 44 provided in the. That is, the housing 26 and the outer needle hub 18, that is, the inner needle unit 14 and the outer needle unit 12 are also brought into contact by the positioning protrusions 100 abutting in the circumferential direction on both sides of the flange portion 40 that sandwich the positioning groove 44. Relative rotation in the circumferential direction is prevented.
- another positioning mechanism for positioning the outer needle hub 18 in the circumferential direction with respect to the operation button 28 includes a relative rotation preventing mechanism for the operation button 28 and the housing 26, the positioning protrusion 100 and the positioning groove 44. It is composed of.
- the peripheral wall portion 32 of the outer needle hub 18 is locked at the formation position of the flange portion 40. It is sandwiched in the radial direction by the contact portion 120 of the protruding piece 118 and the insertion portion 124 which is the tip portion of the inner needle hub 24.
- the peripheral wall portion 32 of the outer needle hub 18 and the contact portion 120 and/or the insertion portion 124 of the lock protrusion 118 may be in contact with each other or separated from each other by a predetermined distance. May be.
- the contact portion 120 of the lock protrusion 118 is inserted from the outer peripheral side (upper side) of the lock groove 42, the contact portion 120 is the groove bottom surface of the lock groove 42 and the peripheral wall of the outer needle hub 18.
- the operation button 28 cannot be moved downward (pressing operation). That is, in the present embodiment, the lock portion that disables the pressing operation of the operation button 28 is configured by inserting the lock protrusion 118 from the outer peripheral side of the lock groove 42.
- the lock portion is on the upper side of the indwelling needle assembly 10, that is, It is provided so as to be exposed to the outer peripheral side at the same position on the circumference as the operation button 28.
- the lower end surface of the contact portion 120 does not have to be in contact with the groove bottom surface of the lock groove 42 (the outer peripheral surface 36 of the outer needle hub 18), and the operation button 28 moves downward and the engaging protrusion 116.
- the lower end surface of the contact portion 120 and the groove bottom surface of the lock groove 42 may be separated from each other so that the engagement between the engaging groove 74 and the engaging recess 74 is not released.
- the support mechanism that positions and supports the outer needle hub 18 substantially coaxially with the housing 26 is such that the insertion portion 124, which is the distal end portion of the inner needle hub 24, has the proximal end side opening of the outer needle hub 18. It is configured such that the outer peripheral surface of the insertion portion 124 and the inner peripheral surface 34 of the outer needle hub 18 come into contact with each other with substantially no gap after being inserted from the portion 38. Particularly, the insertion portion 124 is inserted into the proximal end side opening portion 38 of the outer needle hub 18 with a certain fitting force to prevent the outer needle unit 12 from unintentionally falling off the inner needle unit 14. obtain.
- the indwelling needle assembly 10 having the above structure is punctured into a blood vessel of a patient with the inner needle 22 and the outer needle 16 being inserted in and out as shown in FIGS.
- the outer needle hub 18 constitutes a delivery operation portion that exerts an operation force for delivering the outer needle 16 to the distal end side with respect to the housing 26.
- the outer needle hub 18 is fed to the distal end side while being coaxially positioned with respect to the housing 26 by the support mechanism.
- the inner needle unit 14 may be pulled out rearward (proximal end side) in the puncturing direction while the outer needle unit 12 is sent forward in the puncturing direction. Thereby, the needle tip 20 of the inner needle 22 can be detached from the blood vessel of the patient.
- the base end side opening 38 of the outer needle hub 18 and the tip end side opening 88 of the housing 26 (housing body 76) are axially separated from each other, and the lock projection 118 and the lock groove 42. Has been separated from.
- the fingers are placed on the upper surface 110a of the operation button 28 and the operation button 28 is pushed downward.
- the base portion 108 of the operation button 28 moves downward in the arrangement area 98
- the lower surface 110b of the base portion 108 and the bottom surface 27a of the arrangement area 98 are overlapped with each other, and the housing 26 (the housing body 76).
- the lock projection 118 of the operation button 28 is inserted into the fitting groove 94 provided in the front end side opening 88 of FIG. Further, when the annular portion 112 of the operation button 28 moves downward, the engaging convex portion 116 comes out from the engaging concave portion 74, and these engagements are released.
- the engagement protrusion 116 that protrudes from the inner peripheral surface 102 of the housing 26 (housing body 76) to the inner peripheral side (upper) moves to the outer peripheral side (lower).
- the inner peripheral surface 102 of the housing 26 is substantially straight over substantially the entire axial length. As a result, the inner needle hub 24 can move inside the housing 26 in the axial direction.
- the inner needle hub 24 and the inner needle 22 are moved toward the proximal end side in the housing 26 according to the biasing force based on the elastic restoring force of the coil spring 122.
- the inner needle 22 is pulled out from the outer needle 16.
- the axial dimension of the housing 26 is made larger than the axial dimension from the needle tip 20 of the inner needle 22 to the proximal end of the inner needle hub 24, and therefore the inner needle hub 24 and the inner needle 22. Moves toward the base end side in the housing 26, so that the needle tip 20 of the inner needle 22 is covered and protected by the housing 26.
- the inner needle hub 24 and the inner needle hub 24 during the pulling operation of the inner needle 22 by the pressing operation of the operation button 28 after puncturing are performed.
- the hitting sound with the cap 80 can be reduced.
- a cap 80 made of an elastic material capable of exerting a shock absorbing action by elastic deformation or viscoelastic deformation when the inner needle hub 24 is brought into contact (the cap 80 is the inner needle hub 24 or The degree of freedom in selecting the material is greater than that of the housing body 76.
- the elastic cap 80 that exerts a shock absorbing action is mounted on the housing 26 side, it serves as a damping material that suppresses the amplification of the hammering sound due to the resonance of the housing 26. Can also work effectively.
- the cap 80 on which the inner needle hub 24 abuts is opened on the base end side of the housing body 76.
- the projection 78 for press-fitting fitting to the portion 78 By non-adhesively assembling the projection 78 for press-fitting fitting to the portion 78, transmission of the hitting sound of the contact of the inner needle hub 24 to the cap 80 to the housing body 76 is reduced, and the resonance of the housing body 76 occurs.
- Inclined surface 82 that reduces the diameter of the inner peripheral surface of the protruding portion 81 of the cap 80 with which the inner needle hub 24 abuts toward the rear side. By so doing, the contact force of the inner needle hub 24 with the cap 80 is gradually increased.
- the contact portion between the inner needle hub 24 and the cap 80 is substantially linear and extends in the circumferential direction.
- the inner needle hub 24 abuts.
- the cap 80 is provided with a tubular protrusion 81, and the tubular protrusion 81 is fitted into the proximal end opening 78 of the housing body 76, and the inner needle hub 24 is attached to the tubular protrusion 81. Since the proximal end of the inner needle hub 24 is inserted, direct contact of the inner needle hub 24 with the housing body 76 is avoided when the inner needle hub 24 hits the cap 80, so that the inner needle hub 24 is prevented from coming into contact with the housing 80.
- the natural length of the coil spring 122 is set smaller than the axial movement distance of the inner needle hub 24, The tapping noise should be reduced by the tensile force of the coil spring 122 when the inner needle hub 24 and the cap 80 are hit (10)
- the outer needle hub provided on the proximal end side of the outer needle 16. 18 has a hemostasis valve 50 attached, and the inner needle 22 The hemostatic valve 50 is disposed so as to pass through the hemostatic valve 50, and a compressive force is exerted on the outer peripheral surface of the hemostatic valve 50 so that the hemostatic valve 50 applies a biasing force to the inner needle 22.
- the pressing operation of the operation button 28 (state of FIG. 7) and the movement of the inner needle hub 24 to the proximal end side (state of FIG. 8) occur at substantially the same time. Explanations are given separately.
- the needle tip 20 of the inner needle 22 is pulled out from the blood vessel of the patient and positioned at the middle portion in the length direction of the outer needle 16.
- it may be performed after the inner needle 22 has been punctured into the blood vessel of the patient, or after the inner needle 22 has been withdrawn from the outer needle unit 12, for example. Good.
- the outer needle unit 12 is placed on the skin of the patient.
- an external flow path such as a syringe to the outer needle hub 18 in such a state from the proximal end side opening 38, the slit 56 of the hemostatic valve 50 is pushed open, and infusion, blood collection, and hemodialysis are performed. Done.
- the operation of pressing the operation button 28 is disabled by the lock portion. Therefore, it is possible to avoid a problem that the inner needle 22 is housed in the housing 26 due to unintentional contact with the operation button 28 before, for example, puncturing.
- the lock portion is unlocked by pushing the outer needle hub 18 forward in the puncturing direction, which is generally performed when puncturing the indwelling needle assembly (the operation button 28 can be pushed). The operability can be improved without performing a special operation when unlocking the lock portion.
- the lock projections 118 provided on the operation button 28 are inserted into the lock grooves 42 provided on the outer needle hub 18, so that the outer needle hub 18 and the operation button 28 are circumferentially moved. Relative rotation is prevented. This prevents the outer needle hub 18 from rotating in the circumferential direction when the outer needle 16 is fed to the distal end side, and the operating force exerted on the outer needle hub 18 in the rotation direction of the outer needle hub 18 is prevented. It is possible to efficiently send the outer needle 16 to the distal end side, since it is avoided that the force is consumed as the force of.
- the delivery operation portion that exerts the operation force to deliver the outer needle 16 to the distal end side is configured by the outer needle hub 18 that is directly fixed to the proximal end side of the outer needle 16, The outer needle 16 is delivered to the distal end side with good transmission efficiency of the operating force.
- the support mechanism is provided and the outer needle hub 18 is sent to the distal end side in a state of being positioned substantially coaxially with the housing 26, more efficient transmission of operating force is possible.
- the outer needle 16 is sent to the tip side.
- the outer needle hub 18 and the operation button 28 are positioned relative to each other in the circumferential direction, the outer needle hub 18 is intended when the indwelling needle assembly 10 is used with the operation button 28 facing upward. It can be prevented from rotating without doing.
- the operation piece 46 for sending the outer needle hub 18 forward in the puncturing direction can be positioned more reliably above, and the operability can be further improved.
- the risk of coming into contact with the base end side opening 38 of the outer needle hub 18 when pushing the outer needle hub 18 forward in the puncturing direction is reduced, and the base end side opening 38.
- the operation button 28 and the operation piece 46 are exposed on the outer peripheral surface and is located above when the indwelling needle assembly 10 is used. It is possible to easily grasp whether or not the pressing operation of is possible.
- the lock portion is configured by inserting the lock protrusion 118 provided on the operation button 28 into the lock groove 42 provided on the outer needle hub 18, and the pressing operation of the operation button 28 can be performed. While being prevented, the circumferential positioning effect is exerted. That is, since the lock portion is configured to also serve as the circumferential positioning mechanism, the structure can be simplified as compared with the case where a circumferential positioning mechanism is separately provided, for example.
- the lock portion is provided so as to be exposed on the outer peripheral surface of the indwelling needle assembly 10.
- the space inside the outer needle hub 18 can be advantageously secured, and the arrangement of the hemostatic valve mechanism 48 and the like can be realized more reliably.
- the distal end portion of the inner needle hub 24 (small diameter portion 66) serves as the insertion portion 124 and enters the inside from the proximal end side opening portion 38 of the outer needle hub 18.
- the peripheral wall portion 32 of the outer needle hub 18 can be sandwiched radially inside and outside by the locking projection 118 (contact portion 120) of the operation button 28 and the insertion portion 124. Therefore, for example, even when an external force in the bending direction is applied to the indwelling needle assembly 10, the inner needle hub 24 can be effectively prevented from coming out of the outer needle hub 18.
- FIGS. 9 and 10 show an indwelling needle assembly 130 according to a second embodiment of the present invention in an initial state.
- the slider 136 is provided axially between the outer needle hub 132 and the housing 134, and after the indwelling needle assembly 130 is punctured, the slider 136 is moved forward in the puncturing direction to move the slider 136.
- the outer needle 16 and the outer needle hub 132 are fed out forward through the puncturing direction. That is, in the present embodiment, the slider 136 constitutes a delivery operation portion to which an operation force for delivering the outer needle 16 to the tip side is exerted.
- the same members and parts as those in the first embodiment are designated by the same reference numerals in the drawings as those in the first embodiment, and detailed description thereof will be omitted.
- the outer needle hub 132 of the present embodiment is the outer needle hub (of the first embodiment) except that the lock groove (42) is not provided above the flange portion 40 provided in the base end side opening 38. Since the structure is similar to that of 18), detailed description thereof will be omitted.
- the housing body 138 of the housing 134 of the present embodiment includes a tubular peripheral wall portion 86 that extends substantially straight as a whole, and the inner diameter dimension of the distal end side opening portion 88 of the peripheral wall portion 86 is reduced. .. Then, from the inner peripheral edge portion of the distal end side opening portion 88, the fitting tubular portion 140 projects toward the distal end side.
- a fitting groove 94 which extends in the axial direction and communicates with the insertion hole 90, is formed above the outer peripheral surface 27 in the distal end side opening 88 of the peripheral wall portion 86.
- the fitting tubular portion 140 has a tubular shape that extends substantially straight, and has an outer diameter dimension and an inner diameter dimension that are smaller than those of the peripheral wall portion 86.
- a ring-shaped tip wall portion 142 projecting toward the inner peripheral side is provided at the tip of the fitting tubular portion 140, and from the inner peripheral edge portion of the tip wall portion 142 toward the tip side.
- the insertion tube portion 144 is projected. That is, the housing body 138 of the present embodiment is configured to include the peripheral wall portion 86, the fitting tubular portion 140, and the insertion tubular portion 144, each of which has a substantially tubular shape. It has a substantially stepped tubular shape with reduced dimensions and inner diameter.
- the distal end portion of the insertion tube portion 144 has a tapered shape corresponding to the proximal end side opening portion 38 of the outer needle hub 18 and gradually decreases in diameter toward the distal end side.
- the operation button 146 as shown in FIGS. 11 and 12 is attached to the housing 134 of the present embodiment. That is, the operation button 146 of the present embodiment is not provided with the lock protrusion (118) as in the first embodiment, but instead is positioned at the upper part of the inner hole 114 so as to open to the inner peripheral side.
- a lock groove 148 as a recess is provided.
- the lock groove 148 has a substantially rectangular cross-sectional shape and is formed over the entire length of the annular portion 112 in the thickness direction (axial direction). That is, the lock groove 148 is opened to the front end surface and the base end surface of the annular portion 112.
- the width dimension of the lock groove 148 is substantially equal to the width dimension of the fitting groove 94 provided in the housing body 138, and in the initial state shown in FIGS. 9 and 10, the annular portion 112 of the operation button 146 is By being inserted into the insertion hole 90 of the housing body 138, the fitting groove 94 and the lock groove 148 communicate with each other in the axial direction.
- the slider 136 includes a tubular wall portion 150 that is substantially tubular in shape as a whole, and has a predetermined axial dimension.
- An annular contact wall portion 154 that protrudes toward the inner peripheral side is formed in the distal end side opening portion 152 of the cylindrical wall portion 150.
- the inner diameters of the cylindrical wall portion 150 and the abutting wall portion 154 are substantially equal to or slightly larger than the outer diameter dimensions of the fitting cylindrical portion 140 and the insertion cylindrical portion 144 in the housing body 138, respectively.
- the inner diameter dimension of the contact wall portion 154 is set to be substantially equal to the inner diameter dimension of the proximal end side opening portion 38 of the outer needle hub 132.
- the outer peripheral surface 156 of the front end side opening portion 152 of the slider 136 is provided with an operation piece 158 as a sending projection piece that protrudes to the outer peripheral side (upper) on a part of the circumference (upper side in FIG. 10).
- the operation piece 158 has a substantially trapezoidal plate shape and protrudes upward with a larger protrusion size than the operation piece 46 provided on the outer needle hub 132.
- a positioning protrusion 160 projecting from the tip end of the cylindrical wall portion 150 to the tip end side is formed on the side (downward) opposite to the side on which the operation piece 158 is provided in the radial direction. ing.
- a lock projection piece as a positioning projection protruding from the base end of the tubular wall portion 150 to the base end side. 164 are formed.
- the lock protrusion 164 is in the shape of a protrusion having a substantially rectangular cross section, and the width dimension of the lock protrusion 164 is determined by the fitting groove 94 provided in the housing body 138 and the lock groove provided in the operation button 146. It is substantially equal to or slightly smaller than the width dimension of 148.
- the inner needle unit 166 of the present embodiment is configured to include the housing 134, the operation button 146, the slider 136, the inner needle 22, and the inner needle hub 24 having the above-described structure. That is, the annular portion 112 of the operation button 146 is inserted into the insertion hole 90 of the housing main body 138 to attach the operation button 146 to the housing main body 138, and from the base end side opening (78) of the housing main body 138. The inner needle 22 and the inner needle hub 24 are inserted, and the proximal end side opening (78) is closed by the cap 80, whereby the inner needle 22 and the inner needle hub 24 are accommodated inside the housing 134.
- the inner needle 22 and the inner needle hub 24 extend toward the distal end side through the inner hole 114 of the operation button 146, that is, the distal end surface of the inner needle hub 24 (the distal end of the small diameter portion 66).
- the surface is in contact with the proximal end surface of the distal end wall portion 142 provided at the distal end portion of the housing body 138, and the annular concave portion 112 of the operation button 146 is provided in the engaging concave portion 74 opening downward of the inner needle hub 24.
- the engaging protrusion 116 protruding from the lower side to the inner peripheral side (upper side) is inserted and engaged.
- the slider 136 is attached to the tip of the housing 134 as described above. That is, the cylindrical wall portion 150 of the slider 136 is superposed on the fitting cylindrical portion 140 of the housing body 138 and is externally attached, and the abutting wall portion 154 of the slider 136 abuts on the distal end surface of the distal end wall portion 142. It is superposed on the insertion tube portion 144 and externally inserted. In other words, the slider 136 is superposed and externally mounted on the tip portion of the housing body 138, and the insertion cylinder portion 144 of the housing body 138 projects from the tip end side opening portion 152 of the slider 136.
- the central axis of the housing 134 and the central axis of the slider 136 are aligned with each other and are supported substantially coaxially. That is, a support mechanism that positions and supports the slider 136 substantially coaxially with respect to the housing 134 is externally inserted by superimposing the slider 136 on the distal end portion of the housing body 138 (the fitting tubular portion of the tubular wall portion 150). 140 and the contact wall portion 154 is inserted into the insertion cylinder portion 144). The slider 136 is axially movable by the support mechanism while being positioned substantially coaxially with the housing 134.
- the lock protrusion 164 protruding from the slider 136 to the base end side is inserted into the fitting groove 94 provided in the housing body 138 and the lock groove 148 provided in the operation button 146. That is, the lock protrusion 164 is inserted from the inner peripheral side into the lock groove 148 opening to the inner peripheral side. Then, the groove upper bottom surface of the lock groove 148 and the upper surface of the lock protrusion 164 abut each other in the direction perpendicular to the axis of the housing 134, that is, in the vertical direction, so that the operation button 146 cannot be moved downward (depressing operation). There is. Therefore, in the present embodiment, the lock protrusion 164 is inserted into the lock groove 148 from the inner peripheral side to form a lock portion that disables the pressing operation of the operation button 146.
- the annular portion 112 of the operation button 146 is inserted into the insertion hole 90 of the housing body 138, and/or the installation area 98 provided on the outer peripheral surface 27 of the housing 134 is provided.
- the housing 134 and the operation button 146 cannot rotate in the circumferential direction with respect to each other.
- the lock protrusions 164 abut in the width direction both side portions 148a, 148a sandwiching the lock groove 148 in the circumferential direction, so that the operation button 146 and the slider 136 in the circumferential direction.
- one of the positioning mechanisms that positions the slider 136 in the circumferential direction with respect to the housing 134 is configured to include the lock protrusion 164 and the lock groove 148.
- the slider 136 can be moved relative to the operation button 146 by inserting the lock protrusion 164 into the fitting groove 94. It is positioned in the circumferential direction via 134. Therefore, in the present embodiment, another positioning mechanism that positions the slider 136 in the circumferential direction with respect to the housing 134 is a circumferential relative rotation preventing mechanism for the housing 134 and the operation button 146, the lock projection 164, and the fitting groove. And 94.
- the indwelling needle assembly 130 of the present embodiment is configured. That is, the inner needle 22 is inserted through the proximal end opening 38 of the outer needle hub 132, penetrates the hemostatic valve mechanism 48 and the outer needle 16, and the needle tip 20 of the inner needle 22 projects from the outer needle 16. .. Further, the distal end side opening portion 152 of the slider 136 is axially continuous with the proximal end side opening portion 38 of the outer needle hub 132, and the housing body 138 protruding from the distal end side opening portion 152 of the slider 136 to the distal end side is inserted. The tubular portion 144 is inserted into the outer needle hub 132 through the opening 38 on the proximal end side of the outer needle hub 132.
- the distal end portion of the insertion tubular portion 144 has a tapered shape corresponding to the proximal end side opening portion 38 of the outer needle hub 132, the outer peripheral surface of the insertion tubular portion 144 and the outer needle hub 132.
- the inner peripheral surface 34 is configured to come into contact with the inner peripheral surface 34 without any gap.
- the insertion tube portion 144 is inserted into the proximal end side opening portion 38 of the outer needle hub 132 with a certain fitting force to prevent the outer needle unit 168 from unintentionally dropping from the inner needle unit 166. Is also possible.
- a positioning protrusion 160 protruding from the lower side of the slider 136 to the tip side is inserted into a positioning groove 44 provided below the flange portion 40 of the outer needle hub 132.
- the peripheral wall portion 32 of the outer needle hub 132 is sandwiched between the insertion cylindrical portion 144 of the housing body 138 and the positioning protrusion 160 of the slider 136 from inside and outside in the radial direction. ing. This prevents relative rotation of the slider 136 and the outer needle hub 132, that is, the inner needle unit 166 and the outer needle unit 168 in the circumferential direction.
- the relative rotation of the inner needle unit 166 and the outer needle unit 168 in the circumferential direction is prevented by, for example, the frictional force of the contact between the inner peripheral surface 34 of the outer needle hub 132 and the outer peripheral surface of the insertion tubular portion 144. It may be like this.
- the slider 136 is provided with a protrusion having the same structure as the lock protrusion 118 in the first embodiment, and the outer needle hub 132 has the same structure as the lock groove 42 in the first embodiment.
- Notch may be provided, and the engagement structure of the protrusion and the notch may be employed instead of or in combination with the engagement between the positioning protrusion 160 and the positioning groove 44, As a result, relative rotation of the slider 136 and the outer needle hub 132 in the circumferential direction may be prevented.
- the indwelling needle assembly 130 having the above-described structure is punctured with the inner needle 22 and the outer needle 16 inserted in and out as shown in FIGS. 9 and 10, and then as shown in FIG.
- the user's finger is placed on the operation piece 158 of the slider 136, and the slider 136 is fed forward in the puncturing direction.
- the outer needle 16 and the outer needle hub 132 are sent forward together with the slider 136 in the puncturing direction, and the outer needle 16 is pushed deeper into the blood vessel of the patient.
- the forward movement of the slider 136 in the puncturing direction may be restricted by, for example, the pull-out prevention mechanism described below. That is, the drop-out preventing mechanism is provided with, for example, unevenness between the overlapping surfaces of the slider 136 and the housing body 138, and the slider 136 is moved to the front side in the puncturing direction by a predetermined distance with respect to the housing body 138. It can be configured by fitting the convex portions into concave and convex portions. As a result, the amount of movement of the slider 136 to the front in the puncturing direction is regulated (the slider 136 can move to the tip side by a predetermined amount), and the slider 136 is effectively prevented from falling off from the housing body 138. In addition, the amount of delivery of the outer needle 16 to the tip side can be specified.
- the lock projection 164 is disengaged from the lock groove 148, and the lock groove 148 provided on the operation button 146 is provided on the groove bottom surface and the slider 136.
- the contact with the upper surface of the lock protrusion 164 is released. This allows the operation button 146 to move downward (press operation).
- the slider 136 is provided between the outer needle hub 132 and the housing 134 in the axial direction, the slider 136 has a predetermined axial dimension, and the operation piece 158 has a protruding amount. Since it is relatively large, it is easy to place the finger on the slider 136 and send it out forward in the puncturing direction. Further, since the operation button 146 and the slider 136 are positioned relative to each other in the circumferential direction, the operation piece 158 provided on the slider 136 can be stably directed upward, and the slider 136 can be forwardly moved in the puncturing direction. The sending operation to the can be realized more easily.
- the positioning of the operation button 28 and the outer needle hub 18 in the circumferential direction is performed by fitting the locking projection 118 (particularly the abutting portion 120) into the locking groove 42 and the positioning projection 100.
- the positioning groove 44 it may be either one. That is, when the operation button 28 is provided so as not to rotate in the circumferential direction with respect to the housing 26, and the positioning protrusion 100 and the positioning recessed groove 44 are provided, the outer needle hub 18 and the operation button 28 are interposed via the housing 26.
- the locking projection 118 and the locking groove 42 do not need to exert the circumferential positioning effect because they are positioned in the circumferential direction.
- the positioning protrusion 100 and the positioning recessed groove 44 may not be provided when the circumferential positioning effect is exerted by the lock protrusion 118 and the lock groove 42.
- the lock portion does not need to have a circumferential positioning function.
- the circumference of the outer needle unit 168 and the inner needle unit 166 is formed by fitting the positioning protrusion 160 into the positioning groove 44 and inserting the insertion tube portion 144 into the outer needle hub 132. Relative rotation in the directions is prevented, and with this structure, the slider 136 and the outer needle hub 132 can be stably slid in the distal direction.
- the outer needle unit 168 and the inner needle unit 166 may be relatively rotated in the circumferential direction without the need to be configured in this way. That is, the positioning protrusion 160 and the positioning groove 44 are not essential, and the inner peripheral surface 34 of the outer needle hub 132 and the outer peripheral surface of the insertion tubular portion 144 do not abut each other, and a gap is provided between them. May be
- the needle tip 20 of the inner needle 22 is covered and protected by the housing 134.
- the present invention is not limited to this mode. That is, when the inner needle 22 moves toward the base end side with respect to the housing 134, the needle tip 20 may protrude from the housing 134, and the needle tip 20 moves toward the tip end side with respect to the housing 134. It may be covered and protected by 136.
- the needle tip 20 of the inner needle 22 after withdrawal is protected by the housings 26 and 134 so that the inner needle units 14 and 166 can be safely discarded.
- the needle tip 20 of the inner needle 22 after being pulled out may project from the housings 26, 134 or the slider 136.
- the operation pieces 46 and 158 are provided on both the outer needle hub 132 and the slider 136, but when the operation piece 158 is provided on the slider 136, the operation is performed on the outer needle hub 132.
- the strip 46 need not be provided.
- the outer peripheral surface of the insertion portion 124 serves as a support mechanism for positioning and supporting the outer needle hub 18 and the housing 26 substantially coaxially, and the outer peripheral surface of the insertion portion 124 is a proximal end side opening portion of the outer needle hub 18.
- the mode is not limited to such a mode. That is, for example, the support mechanism may be configured by sandwiching the peripheral wall portion 32 of the outer needle hub 18 in the vertical direction between the contact portion 120 of the lock protrusion 118 and the positioning protrusion 100.
- the peripheral wall portion 32 of the outer needle hub 18 is radially and internally sandwiched by the insertion portion 124, which is the tip portion of the inner needle hub 24 that enters the inside of the outer needle hub 18, and the contact portion 120 and/or the positioning protrusion 100.
- the support mechanism may be formed by sandwiching the support mechanism.
- a concave-convex fitting portion may be provided between the contact portion 120 and/or the positioning protrusion 100 and the outer peripheral surface 36 of the outer needle hub 18, or between the insertion portion 124 and the inner peripheral surface 34 of the outer needle hub 18.
- the support mechanism may be configured by providing a portion in which the concave and convex portions are fitted.
- two or more of the above-exemplified aspects may be combined and employed.
- the lock portion (the lock protrusion 118 and the lock groove 42 in the first embodiment, the lock protrusion 164 and the lock groove 148 in the second embodiment) is the outer circumference of the indwelling needle assembly 10, 130. Although it is exposed on the surface, it may be provided inside the indwelling needle assemblies 10 and 130, that is, inside the outer needle hubs 18 and 132 and inside the slider 136. Further, the lock portion and the operation buttons 28 and 146 do not have to be provided at the same position (upper) on the circumference, and for example, the lock portion is located in the radial direction with the inner needle 22 sandwiched with respect to the operation buttons 28 and 146. It may be provided on the opposite side.
- the outer needle hub 18 is provided with the lock groove 42 (positioning recess) and the operation button 28 is provided with the lock projection 118 (positioning projection). Is provided with a positioning concave portion, and the outer needle hub 18 is provided with a positioning convex portion that projects toward the proximal end side. Movement may be blocked.
- the slider 136 is provided with the lock projection 164 (positioning projection) and the operation button 146 is provided with the lock groove 148 (positioning recess).
- the operation button 146 is provided with a concave portion and a positioning convex portion protruding toward the distal end side, and the positioning concave and convex portions are fitted into the concave and convex portions to abut in the vertical direction, thereby preventing movement of the operation button 28 in the pressing direction. You may come to like.
- the coil spring 122 is used as the biasing means, but rubber or leaf springs that utilize elasticity, or magnets that utilize magnetic force may be employed.
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Abstract
Description
本発明は、意図しない操作部材の押下操作を防止することができる、新規な構造の留置針組立体を提供することを解決課題とする場合がある。
本発明は、内針がハウジング内に収容される際の衝撃音が静かな、新規な構造の留置針組立体を提供することを解決課題とする場合がある。
(1)前記内針ハブの当接に際して弾性変形乃至は粘弾性的変形による衝撃吸収作用が発揮される弾性を有する材質からなる前記キャップを採用する構成
(2)前記内針ハブと前記キャップの当接部に対して衝撃吸収作用を発揮する緩衝材を配する構成
(3)前記内針ハブが当接する前記キャップを前記ハウジング本体の基端側開口部に対して、圧入嵌合用の突起により非接着で組み付けることで、前記内針ハブの該キャップへの当接打音の該ハウジング本体への伝達を軽減する構成
(4)前記内針ハブの基端側の外周部分が当接する前記キャップの筒状の内周面を後方に向かって縮径する傾斜面とすることで該内針ハブの該キャップへの当接力が次第に大きくされるようにする構成
(5)前記内針ハブと前記キャップとの当接部位が周方向に延びる略線状とされて当接面の幅寸法を小さくされることにより、平面当たりによる大きな打音を回避する構成
(6)前記内針ハブと前記キャップとが周方向に延びる当接部分によって当接されるようになっていると共に、該内針ハブと該キャップの少なくとも一方の当接部分において周方向で部分的な切欠きや凹所が設けられて、該内針ハブと該キャップとの当接部位が周方向で部分的とされることで、当接部位の変形による緩衝作用及び/又は当接面積の縮小による打音軽減作用が発揮されるようにする構成
(7)前記キャップに当接する前記内針ハブの基端部分が、該キャップ側に向かって次第に拡開する内周面及び/又は該キャップ側に向かって次第に先細となる外周面によって剛性が低下されて、該内針ハブの該キャップへの当接部分における打当り変形による緩衝作用が発揮されるようにする構成
(8)前記内針ハブが当接する前記キャップに筒状の突出部を設けて、該筒状の突出部をハウジング本体の基端側開口部へ嵌め入れると共に、該筒状の突出部に対して該内針ハブの基端側端部が入り込むようにすることで、該内針ハブの該キャップへの打ち当り作動に際しての該内針ハブの該ハウジング本体への直接の接触が回避されて、硬質の該ハウジング本体への接触に起因する音の発生が防止されるようにする構成
(9)前記付勢部材としてコイルスプリングを採用すると共に、該コイルスプリングの自然長を該内針ハブの軸方向の移動距離よりも小さく設定し、該内針ハブと該キャップとの打当りに際しての該コイルスプリングの引張力による打音の低減作用が発揮されるようにする構成
(10)前記外針の基端側に設けられた外針ハブに止血弁が組み付けられており、前記内針が該止血弁を貫通して配されていると共に、該止血弁の外周面には圧縮力が及ぼされて、該圧縮力により該止血弁が該内針に付勢力を加えている構成
(1)内針ハブ24の当接に際して弾性変形乃至は粘弾性的変形による衝撃吸収作用が発揮される弾性を有する材質からなるキャップ80を採用すること(なお、キャップ80は内針ハブ24やハウジング本体76よりも材質の選択自由度が大きい。しかも、衝撃吸収作用を発揮する弾性のキャップ80はハウジング26側に装着されることから、ハウジング26の共鳴による打音増幅を抑える制振材としても効果的に作用し得る。)
(2)内針ハブ24とキャップ80の当接部に対して衝撃吸収作用を発揮する緩衝材を配すること
(3)内針ハブ24が当接するキャップ80をハウジング本体76の基端側開口部78に対して、圧入嵌合用の突起83により非接着で組み付けることで、内針ハブ24のキャップ80への当接打音のハウジング本体76への伝達を軽減して、ハウジング本体76の共鳴作用等で当接打音が増幅されるのを軽減乃至は回避すること
(4)内針ハブ24が当接するキャップ80の突出部81の内周面を後方に向かって縮径する傾斜面82とすることで内針ハブ24のキャップ80への当接力が次第に大きくされるようにすること
(5)内針ハブ24とキャップ80との当接部位が周方向に延びる略線状とされて当接面の幅寸法を小さくされることにより、平面当たりによる大きな打音を回避すること
(6)内針ハブ24とキャップ80の少なくとも一方の当接部分において周方向で部分的な切欠きや凹所が設けられて、内針ハブ24とキャップ80との当接部位が周方向で部分的とされることで、当接部位の変形による緩衝作用及び/又は当接面積の縮小による打音軽減作用が発揮されるようにすること
(7)キャップ80に当接する内針ハブ24の基端部分が、キャップ80側に向かって次第に拡開する内周面及び/又はキャップ80側に向かって次第に先細となる外周面によって剛性が低下されて、内針ハブ24のキャップ80への当接部分における打当り変形による緩衝作用が発揮されるようにすること
(8)内針ハブ24が当接するキャップ80に筒状の突出部81を設けて、該筒状の突出部81をハウジング本体76の基端側開口部78へ嵌め入れると共に、該筒状の突出部81に対して内針ハブ24の基端側端部が入り込むようになっていることで、内針ハブ24のキャップ80への打ち当り作動に際しての内針ハブ24のハウジング本体76への直接の接触が回避されて、硬質のハウジング本体76に対する内針ハブ24の接触に起因する音の発生が防止されるようにすること
(9)コイルスプリング122の自然長を内針ハブ24の軸方向の移動距離よりも小さく設定し、内針ハブ24とキャップ80との打当りに際してのコイルスプリング122の引張力による打音の低減作用が発揮されるようにすること
(10)外針16の基端側に設けられた外針ハブ18に止血弁50が組み付けられており、内針22が止血弁50を貫通して配されていると共に、止血弁50の外周面には圧縮力が及ぼされて、当該圧縮力により止血弁50が内針22に付勢力を加えていること
Claims (9)
- ハウジングの先端側に突出して配された外針に内針が挿通されており、該ハウジングの外周面に露呈して設けられた操作部材を押下操作することで、該内針が付勢部材によって該ハウジングに収容される留置針組立体であって、
前記外針を前記ハウジングから先端側へ送り出す操作力が及ぼされる送出操作部において、前記操作部材の押下方向への移動を阻止し且つ該送出操作部による該外針の送り出しによってかかる移動の阻止が解除されるロック部が設けられている一方、該送出操作部を該操作部材に対して該ハウジングの周方向で位置決めする位置決め機構が設けられている留置針組立体。 - 前記送出操作部が、前記外針が基端側に備えている外針ハブによって構成されている請求項1に記載の留置針組立体。
- 前記送出操作部が、前記外針が基端側に備えている外針ハブと前記ハウジングとの間に配されたスライダによって構成されている請求項1に記載の留置針組立体。
- 前記ハウジングに対して前記送出操作部を同軸的に位置決めしつつ先端側への送り出しを許容する支持機構が設けられていると共に、
前記ロック部が、前記操作部材と該送出操作部とにおける前記ハウジングの軸直角方向での当接構造によって構成されている請求項1~3の何れか1項に記載の留置針組立体。 - 前記位置決め機構が、前記操作部材と前記送出操作部とにおける前記ハウジングの周方向での当接構造によって構成されている請求項1~4の何れか1項に記載の留置針組立体。
- 前記操作部材と前記送出操作部との一方には他方に向かって開口する位置決め凹部が設けられていると共に、該操作部材と該送出操作部との他方には一方に向かって突出する位置決め凸部が設けられており、
該位置決め凸部が該位置決め凹部へ差し入れられていると共に、該送出操作部による前記外針の送り出しによって該位置決め凸部が該位置決め凹部から離脱されるようになっていることで、前記ロック部と前記位置決め機構とが構成されている請求項1~5の何れか1項に記載の留置針組立体。 - 前記送出操作部には、前記外針を前記ハウジングから先端側へ送り出す操作力が直接に及ぼされ得る送出用突片が、前記ハウジングの前記操作部材と周方向において対応する位置で外周上に突出して設けられている請求項1~6の何れか1項に記載の留置針組立体。
- 前記内針が基端側に備えている内針ハブが、前記付勢部材により基端側に付勢されて前記ハウジング内に配されていると共に、前記操作部材における押下方向の先端側には該ハウジング内に突出して該内針ハブと係合することで該付勢部材による該内針ハブの移動を阻止する係合部が設けられており、該操作部材の押下方向への移動により該係合部が該ハウジングの外方へ移動して該内針ハブへの係合が解除されるようになっている請求項1~7の何れか1項に記載の留置針組立体。
- ハウジングの先端側に突出して配された外針に内針が挿通されており、該ハウジングの外周面に露呈して設けられた操作部材を押下操作することで、該内針が付勢部材によって該ハウジングに収容される留置針組立体であって、
前記内針が基端側に内針ハブを備えていると共に、前記ハウジングの基端側にはキャップが配されており、該内針の該ハウジングへの収容に際しての前記付勢部材による該内針の基端側への移動端が該内針ハブの該キャップへの当接によって規定される一方、該内針ハブの該キャップへの打音の軽減機構として以下(1)~(10)の少なくとも一つが採用されている留置針組立体。
(1)前記内針ハブの当接に際して弾性変形乃至は粘弾性的変形による衝撃吸収作用が発揮される弾性を有する材質からなる前記キャップを採用する構成
(2)前記内針ハブと前記キャップの当接部に対して衝撃吸収作用を発揮する緩衝材を配する構成
(3)前記内針ハブが当接する前記キャップをハウジング本体の基端側開口部に対して、圧入嵌合用の突起により非接着で組み付けることで、前記内針ハブの該キャップへの当接打音の該ハウジング本体への伝達を軽減する構成
(4)前記内針ハブの基端側の外周部分が当接する前記キャップの筒状の内周面を後方に向かって縮径する傾斜面とすることで該内針ハブの該キャップへの当接力が次第に大きくされるようにする構成
(5)前記内針ハブと前記キャップとの当接部位が周方向に延びる略線状とされて当接面の幅寸法を小さくされることにより、平面当たりによる大きな打音を回避する構成
(6)前記内針ハブと前記キャップとが周方向に延びる当接部分によって当接されるようになっていると共に、該内針ハブと該キャップの少なくとも一方の当接部分において周方向で部分的な切欠きや凹所が設けられて、該内針ハブと該キャップとの当接部位が周方向で部分的とされることで、当接部位の変形による緩衝作用及び/又は当接面積の縮小による打音軽減作用が発揮されるようにする構成
(7)前記キャップに当接する前記内針ハブの基端部分が、該キャップ側に向かって次第に拡開する内周面及び/又は該キャップ側に向かって次第に先細となる外周面によって剛性が低下されて、該内針ハブの該キャップへの当接部分における打当り変形による緩衝作用が発揮されるようにする構成
(8)前記内針ハブが当接する前記キャップに筒状の突出部を設けて、該筒状の突出部をハウジング本体の基端側開口部へ嵌め入れると共に、該筒状の突出部に対して該内針ハブの基端側端部が入り込むようにすることで、該内針ハブの該キャップへの打ち当り作動に際しての該内針ハブの該ハウジング本体への直接の接触が回避されて、硬質の該ハウジング本体への接触に起因する音の発生が防止されるようにする構成
(9)前記付勢部材としてコイルスプリングを採用すると共に、該コイルスプリングの自然長を該内針ハブの軸方向の移動距離よりも小さく設定し、該内針ハブと該キャップとの打当りに際しての該コイルスプリングの引張力による打音の低減作用が発揮されるようにする構成
(10)前記外針の基端側に設けられた外針ハブに止血弁が組み付けられており、前記内針が該止血弁を貫通して配されていると共に、該止血弁の外周面には圧縮力が及ぼされて、該圧縮力により該止血弁が該内針に付勢力を加えている構成
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AU2019390047A AU2019390047A1 (en) | 2018-11-29 | 2019-11-26 | Indwelling needle assembly |
BR112021010207-8A BR112021010207A2 (pt) | 2018-11-29 | 2019-11-26 | montagem de agulha permanente |
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