WO2023074756A1 - 針組立体 - Google Patents

針組立体 Download PDF

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Publication number
WO2023074756A1
WO2023074756A1 PCT/JP2022/039995 JP2022039995W WO2023074756A1 WO 2023074756 A1 WO2023074756 A1 WO 2023074756A1 JP 2022039995 W JP2022039995 W JP 2022039995W WO 2023074756 A1 WO2023074756 A1 WO 2023074756A1
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WO
WIPO (PCT)
Prior art keywords
needle
valve housing
housing
valve
needle assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2022/039995
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
和紀 奥田
広樹 横田
辰也 工藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nipro Corp filed Critical Nipro Corp
Priority to JP2023556607A priority Critical patent/JPWO2023074756A1/ja
Publication of WO2023074756A1 publication Critical patent/WO2023074756A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a needle assembly in which a valve housing is directly fixed to a proximal end portion of an outer needle, and in particular, a valve body for switching opening and closing of an internal flow channel of the valve housing and a valve body for preventing air from remaining in the internal flow channel.
  • An air bleed passage and a filter for preventing leakage of blood or the like through the air bleed passage relate to a needle assembly housed in a valve housing.
  • Patent Document 1 discloses a structure including a valve body for hemostasis. That is, the valve housing is directly fixed to the proximal end of the hollow needle body, and the valve body is disposed in the internal flow path of the valve housing that communicates with the inner lumen of the needle body. communication and cutoff can be switched by a valve body.
  • an air release passage for discharging the air may be provided.
  • a filter that allows the passage of gas and restricts the passage of liquid may be arranged on the air vent passage.
  • a groove provided in a catheter hub serving as a valve housing forms a fluid passage for bleeding air between the catheter hub and a valve body, and is arranged to cover the proximal opening of the fluid passage.
  • a seal member acting as a filter prevents leakage of blood through the fluid passageway while allowing air to escape through the fluid passageway.
  • the valve body is formed of elastomer or the like, and the filter is a member of a porous structure that allows gas to pass through. Since it is a deformable member, it may not be possible to achieve stable attachment to the valve housing simply by fitting it to the inner peripheral surface of the valve housing. In addition, when trying to fit the deformable valve body and filter into the inner circumference of the valve housing, it is difficult to correctly arrange the valve body and filter at appropriate positions, and there is a possibility that the mounting work will become difficult.
  • a problem to be solved by the present invention is to provide a needle assembly with a novel structure that allows easy and stable attachment of a valve body and a filter to a valve housing that is directly fixed to a hollow needle body. .
  • a first aspect comprises a hollow needle body, a cylindrical valve housing directly fixed to the proximal end of the needle body and having an internal flow path communicating with the inner lumen of the needle body, and a valve body that switches between communication and blocking of the internal flow path; an air release passage that communicates the internal flow path of the valve housing with an external space on the distal end side of the valve body; a filter for allowing passage of gas and restricting passage of liquid through said valve housing, said valve housing comprising first, second and third members interlocked with said valve housing;
  • the valve body is sandwiched between the first member and the second member provided with the fixing portion of the needle body, and the third member is attached to the first member and the first member in a state of being externally inserted.
  • the air vent passage is formed between and the filter is sandwiched between the first member and the third member.
  • valve body is sandwiched between the first member and the second member, and the filter is sandwiched between the first member and the third member. Therefore, the valve body and the filter can be attached stably.
  • a second aspect is the needle assembly according to the first aspect, wherein the engaging portion provided in the first member is a concave groove that opens in the outer peripheral surface of the second member and extends in the axial direction. , and axially extending notches penetrating the third member in the direction perpendicular to the axis, and are engaged with the second member and the third member in the circumferential direction, whereby the first The member, the second member and the third member are positioned relative to each other in the circumferential direction.
  • the first member, the second member, and the third member are inserted into the recessed groove and the notch of the locking portion so that the relative orientations in the circumferential direction are properly set and assembled while being guided in the axial direction, the first member, the second member, and the third member can be easily assembled in an appropriate circumferential direction.
  • the locking portion of the first member is inserted into the groove of the second member and the notch of the third member and locked in the circumferential direction, thereby causing relative rotation of the first member, the second member and the third member. can be restricted. Therefore, the valve body sandwiched between the first member and the second member and the filter sandwiched between the first member and the third member can be stably supported. Also, by restricting the relative rotation between the constituent members of the valve housing that are directly fixed to the needle body, the relative orientation of the needle body and the valve housing in the circumferential direction is fixed, Problems such as applying force to the puncture site of the needle body to the patient and torsionally deforming the needle body itself due to the relative rotation between the constituent members of the valve housing can be avoided.
  • a third aspect is the needle assembly according to the second aspect, wherein the engaging portions are provided on both radial sides of the first member, and the grooves are provided on both radial sides of the second member. respectively, and the cutouts are provided on both sides in the radial direction of the third member.
  • the first member, the second member, and the third member each have a circumferential positioning structure on both sides in the radial direction, the first member and the second member and the third member are more stably positioned in the circumferential direction. Moreover, the first member and the second member are radially positioned by inserting the locking portions on both radial sides of the first member into the concave grooves on both radial sides of the second member.
  • a fourth aspect is the needle assembly according to any one of the second and third aspects, wherein the second member has a protrusion that protrudes from the outer peripheral surface and extends in the circumferential direction, and the concave groove is formed on the protrusion.
  • the second member is not made large in diameter over the entire length in the axial direction, and the second member is not partially thinned in the circumferential direction.
  • a groove can be formed in the
  • a fifth aspect is the needle assembly according to any one of the first to fourth aspects, wherein the outer peripheral surface of the valve housing has a protrusion or a step for pressing the valve housing toward the distal end side. It is provided with a shaped operation surface.
  • the needle assembly constructed according to this aspect for example, when the inner needle is inserted into the needle body and the inner needle is pulled out from the needle body after being punctured by the patient, the user, such as a doctor, etc. However, by pressing the operation surface with the index finger while holding the inner needle side, the inner needle can be pulled out from the needle body while maintaining the needle body in a state of puncturing the patient.
  • the first member is directly fixed to the needle body, the base end surface of the first member is exposed to the external space, and the operation surface extends over the base end surface of the first member. It is also possible to employ a combination of configurations configured to include. According to this, the base end surface of the first member directly fixed to the needle body constitutes at least a part of the operation surface, so that when the operation surface is pushed while holding the inner needle, The applied force (operating force) is efficiently transmitted to the needle body, and the needle body can be prevented from slipping out of the patient.
  • a sixth aspect comprises a hollow needle body, a tubular valve housing having an internal flow path connected to the proximal end side of the needle body and communicating with the inner lumen of the needle body, and the valve housing of the valve housing.
  • a valve body that switches between communication and blocking of the internal flow path; an air release passage that communicates the internal flow path of the valve housing with the external space on the distal end side of the valve body; a filter for permitting passage of gas and restricting passage of liquid, said valve housing comprising first, second and third members interlocked with said needle;
  • the valve body is sandwiched between the first member and the second member provided with a fixed portion of the body, and the first member and the third member attached to the first member in an extrapolation state.
  • the air vent passage is formed therebetween, the filter is sandwiched between the first member and the third member, and the outer dimensions of the valve housing are two diameters of the valve housing that are perpendicular to each other. They are mutually different in direction.
  • the needle assembly constructed according to this aspect, for example, by setting the radial direction (minor axis direction) in which the outer dimension of the valve housing is small as the direction in which the patient's body surface is located, the needle body is placed on the patient.
  • the needle assembly is left in a punctured state, the amount of projection of the valve housing on the patient's body surface can be suppressed, and the valve housing hardly becomes an obstacle.
  • the short axis direction of the valve housing to the direction in which the patient's body surface is positioned, in a structure in which the valve housing is directly fixed to the needle body, the force exerted by the valve housing coming into contact with the patient's body surface is reduced.
  • the load on the puncture site can be reduced, for example.
  • a seventh aspect is the needle assembly according to the sixth aspect, wherein a planar portion is provided on an outer peripheral surface of the valve housing in one of the two radial directions of the valve housing, and the The two radial outer dimensions of the valve housing are smaller in one direction in which the planar portion is provided than in the other direction.
  • the contact area between the patient and the valve housing is increased. Pain and discomfort can be alleviated by reducing contact pressure (distributing force acting on the patient). Further, since the flat portion is provided on the outer peripheral surface of the valve housing, rolling of the valve housing can be prevented.
  • An eighth aspect is the needle assembly according to the seventh aspect, wherein the engaging portion provided in the first member is a concave groove that opens in the outer peripheral surface of the second member and extends in the axial direction. , and axially extending notches formed in the third member, so that the engaging portion of the first member is engaged with the second member and the third member in the circumferential direction. Accordingly, the first member, the second member, and the third member are positioned relative to each other in the circumferential direction, and the planar portion is provided at a portion of the first member including the locking portion. There is.
  • the locking portion of the first member is inserted into the groove of the second member and the notch of the third member and locked in the circumferential direction, Relative rotation of the first member, the second member and the third member can be restricted.
  • the first member, the second member, and the third member are assembled by being guided in the axial direction while their relative orientations in the circumferential direction are properly set by inserting them into the grooves and notches of the locking portion. , the first member, the second member and the third member can be easily assembled in an appropriate circumferential orientation.
  • the planar portion including the portion formed by the locking portion on the outer peripheral surface of the valve housing By providing the planar portion including the portion formed by the locking portion on the outer peripheral surface of the valve housing, the locking area in the circumferential direction between the locking portion and the wall inner surface of the recessed groove and notch is secured. At the same time, it is possible to reduce the size of the valve housing in one radial direction by suppressing the protrusion of the engaging portion to the outer periphery.
  • a ninth aspect is the needle assembly according to any one of the first to eighth aspects, wherein a sleeve is inserted into the proximal end of the needle body to fix the needle body to the first member.
  • the third member which is externally inserted on the first member, is arranged so as to deviate from the base end side of the fixing member.
  • valve body and the filter can be easily and stably attached to the valve housing directly fixed to the hollow needle body.
  • FIG. 1 is a perspective view of an indwelling needle assembly provided with an indwelling needle as a first embodiment of the present invention
  • FIG. 2 is an enlarged perspective view of an outer needle unit that constitutes the indwelling needle assembly shown in FIG. 1
  • FIG. 4 is an enlarged view of the VI-VI cross section of FIG.
  • a diagram showing an enlarged VII-VII cross section of FIG. 4 is a perspective view of a first member constituting an outer needle hub of the outer needle unit shown in FIG. 3
  • FIG. 9 is a perspective view showing the first member of FIG. 8 at another angle
  • FIG. 12 The perspective view of the 2nd member which comprises the outer needle hub of the outer needle unit shown in FIG.
  • FIG. 12 is a perspective view showing the second member of FIG. 11 at another angle
  • XIII-XIII sectional view of FIG. 4 is a perspective view of a third member constituting an outer needle hub of the outer needle unit shown in FIG. 3
  • FIG. FIG. 15 is a perspective view showing the third member of FIG. 14 at another angle
  • FIGS. 1 and 2 show an indwelling needle assembly 12 provided with an outer needle unit 10, which is a first embodiment of a needle assembly constructed according to the present invention.
  • the indwelling needle assembly 12 includes an inner needle unit 14 and an outer needle unit 10 . 2 and 4, which is the direction of the needle axis of the outer needle 66.
  • the left side in FIG. The right side in 2 is defined as the base end side.
  • the vertical direction means the vertical direction in FIGS. 2 and 4
  • the horizontal direction means the direction orthogonal to the plane of FIGS. 2 and 4 (the vertical direction in FIG. 5).
  • the inner needle unit 14 includes an inner needle 16.
  • the inner needle 16 is a hollow needle having a sharp tip 18 at its tip, and is made of a known material such as stainless steel, aluminum, titanium, or alloys thereof.
  • the needle tip 18 is formed by forming a blade surface 20 that widens in a direction inclined with respect to the axial direction of the distal end surface of the inner needle 16, and has a sharp shape that can easily puncture the patient's skin or the like.
  • the inner needle 16 may be a solid needle.
  • An inner needle hub 22 is attached to the proximal end portion of the inner needle 16 .
  • the inner needle hub 22 is made of a hard synthetic resin material such as polypropylene, and has a substantially cylindrical shape as a whole.
  • An annular stepped surface 24 is formed on the inner peripheral surface of the inner needle hub 22 , and the tip side of the stepped surface 24 is a small-diameter portion 26 having a small inner diameter, and the proximal end of the stepped surface 24 is set to be smaller than the stepped surface 24 .
  • a large-diameter portion 28 having a larger inner diameter than the small-diameter portion 26 is formed on the side.
  • the inner diameter dimension of the small diameter portion 26 is substantially equal to or slightly larger than the outer diameter dimension of the inner needle 16 .
  • the proximal end portion of the inner needle 16 is inserted into the small diameter portion 26 of the inner needle hub 22, and if necessary, a treatment such as adhesion is applied, so that the proximal end portion of the inner needle 16 is attached to the small diameter portion 26. It is fixedly attached, thereby securing the proximal portion of the inner needle 16 to the inner needle hub 22 .
  • the outer peripheral surface of the small diameter portion 26 and the outer peripheral surface of the large diameter portion 28 are continuous in the axial direction without a step.
  • the outer peripheral surface of the small diameter portion 26 has a tapered shape that substantially corresponds to the inner peripheral surface of the proximal end portion of the outer needle hub 68.
  • the distal end portion of the small diameter portion 26 is the outer needle.
  • the inner peripheral surface of the outer needle hub 68 and the outer peripheral surface of the distal end portion of the small-diameter portion 26 are brought into contact with each other with substantially no gap when the hub 68 is inserted into the inner periphery of the outer needle hub 68 through the opening on the base end side of the hub 68 . It has become.
  • the outer diameter dimension of the distal end portion of the small diameter portion 26 may be smaller than the inner diameter dimension of the outer needle hub 68, and there is a gap between the inner peripheral surface of the outer needle hub 68 and the outer peripheral surface of the distal end portion of the small diameter portion 26. A gap may be formed.
  • a filter that restricts passage of liquid and allows passage of gas may be provided at the proximal opening of the inner needle hub 22 (that is, the proximal opening of the large diameter portion 28).
  • the blood that has flowed through the inner hole of the inner needle 16 is retained inside the large diameter portion 28, and the blood from the base end opening of the inner needle hub 22 is drained. Leakage can be prevented.
  • the inner needle hub 22 and the housing 36 from a transparent material, when the indwelling needle assembly 12 is punctured, reverse blood (flashback) can be confirmed by the blood flowing into the inside of the large diameter portion 28. You may make it possible.
  • the large-diameter portion 28 of the inner needle hub 22 has a plurality of protrusions 30 projecting outward from the proximal opening (that is, the proximal opening of the large-diameter portion 28).
  • the protruding portion 30 extends linearly in the axial direction, and has a guide protruding portion 32 protruding to the outer periphery at the end on the base end side.
  • the number of protrusions 30 is not particularly limited, but in this embodiment, three are provided at positions separated from each other in the circumferential direction.
  • the small diameter portion 26 of the inner needle hub 22 is formed with an engaging recess 34 that opens to the outer peripheral surface.
  • the engaging recess 34 is formed in a part of the circumferential direction, and in this embodiment, it opens downward (downward in FIG. 2).
  • the inner needle 16 and inner needle hub 22 are supported by the housing 36.
  • the housing 36 is made of hard synthetic resin similar to the inner needle hub 22 .
  • the housing 36 as a whole has a substantially cylindrical shape with a bottom. More specifically, the housing 36 includes a substantially cylindrical housing body 38 and a cap 40 that closes the base end opening of the housing body 38 .
  • the housing body 38 has an axial dimension greater than the axial dimension from the needle point 18 of the inner needle 16 to the proximal end of the inner needle hub 22 .
  • the inner diameter of the housing body 38 is substantially constant and slightly larger than the outer diameter of the inner needle hub 22 .
  • the inner diameter of the housing body 38 is smaller than that of the other portion of the housing main body 38, and is smaller than the outer diameter of the inner needle hub 22 at the portion where the protrusion 30 is provided. It is substantially equal to or slightly larger than the outer diameter dimension of the inner needle hub 22 at the portion other than the portion where the streak portion 30 is formed.
  • an insertion hole 42 penetrating vertically is formed in the tip portion of the housing body 38 .
  • the insertion hole 42 has a substantially rectangular shape in plan view, and the width dimension in the left-right direction (the dimension in the direction perpendicular to the plane of FIG. 2) is larger than the dimension in the axial direction.
  • a portion of the insertion hole 42 that penetrates the lower portion of the housing body 38 has an opening shape that substantially corresponds to the engaging recess 34 of the inner needle hub 22 when the inner needle hub 22 is attached to the housing 36, which will be described later.
  • a surrounding protrusion 44 that protrudes to the outer peripheral side (upward) is formed on a part of the periphery (upper in FIG. 2).
  • the surrounding protrusion 44 has a substantially triangular vertical cross section, extends in a substantially U-shape or a substantially U-shape, and opens toward the tip side.
  • the surrounding protrusion 44 is provided closer to the proximal end than the insertion hole 42 , and the distal end opening of the surrounding protrusion 44 communicates with the insertion hole 42 .
  • a positioning protrusion 46 is formed at the tip of the housing body 38 and protrudes toward the tip from the bottom.
  • the positioning projection 46 has a substantially rectangular shaft shape, and the width dimension of the positioning projection 46 in the left-right direction is substantially equal to the groove width dimension of the positioning groove 108 provided in the threaded portion 106 of the outer needle hub 68 to be described later. , has been made slightly smaller.
  • the housing main body 38 has a guide groove 48 that opens toward the inner periphery.
  • the guide groove 48 has a substantially rectangular cross-sectional shape and extends in the axial direction at a plurality of points in the circumferential direction.
  • the guide grooves 48 are provided at positions corresponding to the protrusions 30 and the guide protrusions 32 of the inner needle hub 22 in the circumferential direction, and are formed at three locations in the circumferential direction.
  • the guide groove 48 reaches the base end of the housing body 38, does not reach the tip, and is formed continuously from the middle in the axial direction to the base end.
  • a cap 40 is attached to the base end opening of the housing body 38 .
  • the cap 40 has a substantially cylindrical shape with a bottom as a whole. It is attached to the proximal opening of body 38 .
  • a cap 40 is attached to the housing main body 38 so as to cover the base end opening, thereby forming a cylindrical housing 36 with a bottom.
  • a through hole 50 is formed through the bottom wall of the cap 40 in the thickness direction so that when the inner needle hub 22 moves inside the housing 36 as will be described later, the air inside the housing 36 is released. The movement of the inner needle hub 22 is less likely to be hindered by the air inside the housing 36 that is discharged to the outside through the through hole 50 .
  • An operation button 52 is assembled to the housing 36 .
  • the operation button 52 is made of the same hard synthetic resin as the housing 36, and has a base portion 54 having the same shape as the area surrounded by the surrounding protrusion 44 in plan view.
  • the base portion 54 has a curved upper surface that protrudes upward, and a lower surface that extends in the axial direction. Since the upper surface of the base portion 54 is curved as described above, a large contact area is secured with the user's finger when the operation button 52 is pressed, and the operability of the pressing operation is improved. can be
  • annular portion 56 protruding downward is formed at the tip portion of the base portion 54 .
  • the annular portion 56 has a ring shape with an outer peripheral surface that is substantially rectangular and an inner peripheral surface that is substantially cylindrical.
  • the upper portion of the annular portion 56 is integrally connected to the base portion 54 .
  • the inner diameter dimension of the annular portion 56 is substantially equal to the inner diameter dimension of the housing main body 38 (inner diameter dimension other than the tip portion where the inner diameter is reduced).
  • the axial and widthwise dimensions of the annular portion 56 are substantially equal to or slightly smaller than the axial and widthwise dimensions of the insertion hole 42 in the housing body 38 .
  • the annular portion 56 is provided with an engaging convex portion 58 protruding inwardly on the side opposite to the side on which the base portion 54 is provided (the downward direction in which the operation button 52 is pushed down) in the radial direction.
  • the inner diameter of the annular portion 56 is reduced at the positions where the engaging projections 58 are formed, and the inner diameter of the housing body 38 at the positions where the engaging projections 58 are formed (vertical inner dimension) is reduced. is approximately equal to the inner diameter dimension of the tip portion of the
  • a lock protrusion 60 projecting toward the tip side is provided at the central portion of the base portion 54 in the width direction (left-right direction), and the tip portion of the lock protrusion 60 is bent toward the inner peripheral side (downward). It has a protruding contact portion 62 .
  • the lateral width of the locking projection 60 is approximately equal to or slightly smaller than the groove width of a positioning groove 108 provided in a threaded portion 106 of an outer needle hub 68, which will be described later.
  • the inner needle 16 and the inner needle hub 22 fixed to each other are inserted through the proximal opening of the housing body 38, and the proximal opening of the housing body 38 is closed with the cap 40, thereby forming the inner needle hub. 22 is housed within housing 36 .
  • the guide protrusions 32 of the inner needle hub 22 are inserted into the guide grooves 48 of the housing body 38, so that the inner needle 16, the inner needle hub 22 and the housing 36 are connected. Circumferential relative rotation with is prevented.
  • the operation button 52 is pre-assembled in the housing 36 before housing the inner needle hub 22 . That is, the annular portion 56 of the operation button 52 is inserted from above into the insertion hole 42 provided at the tip portion of the housing body 38, and the base portion 54 is inserted into the area surrounded by the surrounding protrusion 44. By doing so, the operation button 52 is assembled to the housing 36 .
  • the operation button 52 is positioned above the housing 36 and exposed on the outer peripheral surface of the housing 36 .
  • the operation button 52 can move downward with respect to the housing 36 by arranging the bottom surface of the area surrounded by the surrounding protrusion 44 and the bottom surface of the base portion 54 so as to be separated from each other in the vertical direction. ing.
  • the annular portion 56 of the operation button 52 is inserted into the insertion hole 42 of the housing body 38 and/or the base portion 54 of the operation button 52 is inserted into the inner peripheral side of the surrounding protrusion 44 of the housing body 38. Thereby, relative rotation in the circumferential direction between the housing 36 and the operation button 52 is prevented. That is, the widthwise side surface of the annular portion 56 is brought into contact with the housing main body 38 and/or the base portion 54 is brought into contact with the surrounding projection 44 so that the housing 36 and the operation button 52 are separated from each other. Circumferential relative rotation with is prevented.
  • the inner needle hub 22 inserted into the housing main body 38 from the proximal end side is inserted through the annular portion 56 of the operation button 52 .
  • the operation button 52 is returned to the initial position before the pressing operation, whereby the engagement projection of the annular portion 56 is restored.
  • Portion 58 is inserted into engagement recess 34 of inner needle hub 22 .
  • a coil spring 64 is arranged between the inner needle hub 22 and the housing 36 .
  • the coil spring 64 is arranged axially between the protrusion 30 provided at the proximal end of the inner needle hub 22 and an inner projection (not shown) projecting inwardly at the distal end of the housing 36 .
  • the ridges 30 and the inner protrusions are close to each other in the axial direction, and the coil spring 64 is inwardly protruding from the ridges 30 . It is compressed between the parts.
  • an urging force toward the proximal end of the housing 36 is applied to the inner needle hub 22 due to the elastic restoring force of the coil spring 64 . Movement of the inner needle hub 22 with respect to the housing 36 due to the urging force is prevented by the engagement between the engaging projection 58 and the engaging recess 34 .
  • the outer needle unit 10 has an outer needle 66 as a needle body.
  • the outer needle 66 has a tubular shape with a lumen 67 penetrating in the axial direction, and is made of a material having appropriate flexibility, such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, polyether nylon resin. It is made of various soft resins such as The tip of the outer needle 66 is tapered, thereby reducing the resistance to puncturing the living body. Further, by providing a through hole in the peripheral wall of the distal end portion of the outer needle 66, it is possible to improve the flow efficiency of fluid such as blood to the lumen 67 of the outer needle 66.
  • ETFE ethylene-tetrafluoroethylene copolymer
  • polyurethane polyurethane
  • polyether nylon resin polyether nylon resin
  • An outer needle hub 68 as a valve housing is attached to the proximal end portion of the outer needle 66 .
  • the outer needle hub 68 is made of, for example, a hard synthetic resin material such as polypropylene.
  • the outer needle hub 68 has a substantially cylindrical shape as a whole and has an internal channel 69 extending therethrough in the axial direction.
  • Outer needle hub 68 includes first member 70 , second member 72 and third member 74 .
  • the first member 70 is directly attached to the proximal portion of the outer needle 66 .
  • the first member 70 as shown in FIGS. 3, 4, and 8 to 10, has a connecting tube portion 76 as a fixed portion that is fixed to the base end portion of the outer needle 66.
  • Both the inner and outer diameters of the connecting tube portion 76 decrease toward the tip, and the overall diameter of the connecting tube portion 76 decreases toward the tip.
  • the inner diameter dimension of the connecting tube portion 76 gradually decreases toward the distal end of each tapered inner surface 78 provided at a plurality of locations in the axial direction.
  • the base end portion of the outer needle 66 is inserted into the distal end portion of the connection tube portion 76 having a small diameter, and the base end portion of the outer needle 66 and the connection tube portion 76 are formed in a sleeve shape (substantially funnel shape).
  • the crimping pin 80 By inserting the crimping pin 80 , the proximal end portion of the outer needle 66 is clamped between the connecting tube portion 76 and the crimping pin 80 and fixed to the first member 70 .
  • the outer needle 66 extends from the first member 70 to the distal end side, and the base end portion is directly overlapped and connected to the first member 70 without interposing another member.
  • the inner diameter dimension of the connecting tube portion 76 is stepped toward the distal end at the stepped inner surface 82 provided closer to the proximal side than the tapered inner surface 78 .
  • the stepped inner surface 82 is an annular flat surface that extends substantially perpendicularly to the axial direction.
  • a ventilation groove 84 that opens to the stepped inner surface 82 is formed in the connecting tube portion 76 .
  • the ventilation groove 84 is partially provided in the circumferential direction of the stepped inner surface 82 and extends in the radial direction. It is desirable that a plurality of ventilation grooves 84 are provided separately from each other in the circumferential direction, and in this embodiment, four are evenly distributed in the circumferential direction.
  • the outer peripheral surface of the connecting tube portion 76 has a plurality of tapered outer surfaces 86 substantially corresponding to the tapered inner surface 78 .
  • the outer peripheral surface of the connecting tube portion 76 has a stepped outer surface 88 on the base end side of the tapered outer surface 86, and the stepped outer surface 88 is an annular flat surface extending substantially perpendicular to the axial direction.
  • the proximal end side has a larger diameter than the distal end side.
  • a ventilation concave portion 90 is formed in the connecting cylinder portion 76 .
  • the ventilation recess 90 opens to the outer peripheral surface of the connecting tube portion 76 on the distal end side of the stepped outer surface 88 .
  • the ventilation recess 90 is provided in a portion corresponding to the ventilation groove 84 in the circumferential direction of the connecting tube portion 76 , and communicates with the ventilation groove 84 at the inner peripheral end. Since the ventilation groove 84 and the ventilation recess 90 are communicated with each other in this way, a ventilation hole 92 penetrating through the peripheral wall portion of the connecting cylinder portion 76 is formed.
  • the ventilation recesses 90a, 90a provided on both upper and lower sides of the connecting tube portion 76 are formed in a substantially circular recess shape, and the ventilation recesses 90b, 90b provided on both left and right sides are groove-shaped extending in the vertical direction.
  • the molding die for molding the outer peripheral surface of the connecting tube portion 76 on the distal end side of the stepped outer surface 88 can have a simple structure in which the mold is vertically split.
  • the first member 70 has a pair of locking portions 94a and 94b projecting from the connecting tube portion 76 toward the base end side.
  • the pair of locking portions 94a and 94b are each formed in a substantially rectangular plate shape, and are disposed on both sides (upper and lower sides) in the radial direction of the connecting tube portion 76 so as to face each other substantially parallel to each other.
  • Each locking portion 94 has a tip portion integrally continuous with the connecting tube portion 76 , protrudes further to the outer peripheral side than the connecting tube portion 76 , and a tip end surface thereof which is continuous with the stepped outer surface 88 . constitute a plane.
  • the outer surface of the engaging portion 94 in the vertical direction is formed in a planar shape that extends substantially perpendicularly to the vertical direction.
  • Each engaging portion 94 has an axial length dimension larger than a width dimension.
  • the proximal end surface of the engaging portion 94a located on the upper side is an operation surface 96 formed of a flat surface extending substantially perpendicularly to the axial direction.
  • a valve body 98 is accommodated in the inner periphery of the connecting tubular portion 76 of the first member 70.
  • the valve body 98 is a disk valve having a slit 100 formed in the central portion thereof, and is made of an elastic rubber elastic body or elastomer.
  • the shape of the slit 100 is not particularly limited, and may be a straight line shape, a cross shape, or the like.
  • the outer diameter dimension of the valve body 98 is slightly larger than the inner diameter dimension of the portion of the coupling tube portion 76 of the first member 70 that houses the valve body 98 in a single product state before being housed in the first member 70 .
  • valve body 98 when the valve body 98 is inserted into the first member 70, the valve body 98 is radially compressed, so the valve body 98 is accommodated in the inner periphery of the first member 70 with the slit 100 closed.
  • the valve body 98 is integrally provided with a cylindrical holding cylinder portion 102 protruding from the outer peripheral end portion toward the base end side.
  • the valve body 98 has an annular holding groove portion 104 that extends in the circumferential direction along the inner circumference of the holding cylinder portion 102 while opening at the base end face.
  • the valve body 98 has the outer peripheral portion of the tip end face superimposed on the stepped inner surface 82 of the first member 70 , and the valve body 98 covers the opening of the ventilation groove 84 on the stepped inner surface 82 .
  • the ventilation groove 84 covered with the valve body 98 to form a tunnel-shaped passage opens radially inward on the tip side of the valve body 98 .
  • the second member 72 has a substantially cylindrical shape as a whole.
  • the second member 72 has a substantially annular threaded portion 106 that protrudes outward from its base end portion.
  • the threaded portion 106 is divided into both sides in the left-right direction by positioning grooves 108, 108 provided at two locations (both upper and lower sides) in the circumferential direction.
  • the tip portion of the second member 72 can be inserted between the pair of engaging portions 94a and 94b of the first member 70 facing each other.
  • Flange-like protrusions 110 and 112 protruding to the outer periphery are provided at the distal end portion of the second member 72 at positions separated from each other in the axial direction.
  • Locking grooves 114 are formed in the protruding portions 110 and 112 of the second member 72, respectively, as recessed grooves that open in the outer peripheral surface and extend in the axial direction.
  • the locking grooves 114 have a shape corresponding to the locking portions 94 of the first member 70 and are provided on both upper and lower sides corresponding to the pair of locking portions 94 .
  • the locking groove 114 of the projecting portion 110 on the distal end side in the axial direction and the locking groove 114 of the projecting portion 112 on the proximal end side in the axial direction are provided in series in the axial direction.
  • a cylindrical valve holding portion 116 is provided on the distal end side of the projecting portion 110 on the distal end side in the axial direction of the second member 72 .
  • the valve holding portion 116 has a smaller outer diameter toward the distal end side and is thinner. It's getting easier.
  • a pair of locking claws 118 , 118 are provided on both left and right sides between the projections 110 , 112 of the second member 72 in the axial direction.
  • the locking claw 118 protrudes outward in the left-right direction, and the protruding tip portion extends to the tip side in the axial direction of the second member 72 and is connected to the protruding portion 110 on the tip side.
  • the engaging claw 118 has an outer peripheral surface having a shape corresponding to the end portion connected to the projecting portion 110 on the distal end side in the axial direction, which is formed by extending the outer peripheral surface of the projecting portion 110 to the proximal end side in the axial direction.
  • the outer peripheral surface of the axially intermediate portion continuously provided on the proximal end side of the end portion serves as a guiding inclined surface 120 whose diameter increases toward the proximal end side in the axial direction.
  • the end surface of the locking claw 118 on the proximal end side in the axial direction serves as a locking surface 122 that extends substantially orthogonally to the axial direction of the second member 72, and the locking claw 118 protrudes in the left-right direction.
  • the dimensions are larger on the proximal side than on the distal side in the axial direction.
  • the locking claw 118 has a connecting portion 124 that protrudes toward the proximal side from the central portion in the circumferential direction, and is connected to the protruding portion 112 on the proximal side in the axial direction by the connecting portion 124 .
  • the engaging claw 118 is connected to the projection 110 on the distal end side and the projecting portion 112 on the proximal end side, so that the deformation rigidity of the engaging claw 118 is enhanced.
  • a pusher engaging portion 126 is provided on the inner peripheral surface of the second member 72 .
  • the pusher engaging portion 126 may be provided continuously over the entire circumference, or may be provided partially in the circumferential direction. In order to efficiently obtain the , it is desirable that the plurality are provided circumferentially apart from each other.
  • a pusher 128 is accommodated in the inner circumference of the second member 72 .
  • the pusher 128 has a substantially cylindrical shape as a whole, and has an inner diameter larger than the outer diameter of the inner needle 16 .
  • the pusher 128 is provided with an engaging stepped surface 130 in the middle of the axial direction on the outer peripheral surface, and the distal end side of the engaging stepped surface 130 protrudes further to the outer periphery than the proximal end side of the engaging stepped surface 130 .
  • the outer peripheral surface of the pusher 128 has a substantially constant diameter on the base end side of the engaging stepped surface 130, and has a tapered shape in which the distal end side of the engaging stepped surface 130 has a smaller diameter toward the tip.
  • the pusher 128 has a thin tip.
  • the pusher 128 is inserted into the second member 72, and the engaging stepped surface 130 of the pusher 128 abuts against the pusher engaging portion 126 of the second member 72 from the tip side to lock in the axial direction. By doing so, the pusher 128 is axially positioned with respect to the second member 72 .
  • the third member 74 has a generally cylindrical shape as a whole.
  • the third member 74 has a distal end cover portion 132 that curves and protrudes inwardly at the distal end portion, and the outer peripheral surface of the distal end cover portion 132 is a curved convex surface that decreases in diameter toward the distal end side.
  • the outer peripheral surface of the third member 74 has a pair of flat surfaces 134, 134 that extend substantially orthogonally to the radial direction on both sides in the radial direction.
  • the flat surface 134 extends linearly in the axial direction in a part of the circumferential direction, and the axial distal end reaches the distal end cover portion 132 and the axial proximal end reaches the proximal end of the third member 74 .
  • the outer diameter dimension of the third member 74 is smaller in the radial direction where the pair of flat surfaces 134, 134 are provided than in other radial directions.
  • a pair of cutouts 136a and 136b are formed in the peripheral wall portion of the third member 74. As shown in FIG. The cutouts 136 are provided on both upper and lower sides of the peripheral wall portion of the third member 74 so as to radially penetrate through the portion where the flat surface 134 is formed.
  • the notch 136 reaches the axial proximal end of the third member 74 and is open to the proximal side, and does not reach the axial distal end of the portion of the third member 74 where the flat surface 134 is formed.
  • the width dimension of the notch 136 is substantially the same as the width dimension of the flat surface 134 . Therefore, the third member 74 has a notch 136 which is open at the proximal end in the axial direction and penetrates in the radial direction.
  • a pair of connecting pieces 138 and 138 are formed between the pair of cutouts 136a and 136b in the circumferential direction.
  • the pair of connecting pieces 138 , 138 each have a curved plate shape extending in the axial direction with an arc-shaped cross section, and are arranged to face each other in the radial direction.
  • a substantially rectangular connecting hole 140 is formed through the connecting piece 138 .
  • the inner peripheral surface of the axial base end portion of the connecting piece 138 is a guide surface 142 that is inclined inwardly from the axial base end toward the tip side at a circumferential position corresponding to the connecting hole 140 .
  • the guide surface 142 has substantially the same circumferential width dimension as the connecting hole 140 , and the circumferential width dimension of the connecting hole 140 and the guide surface 142 is the same as the circumferential width dimension of the locking claw 118 of the second member 72 . are assumed to be approximately the same.
  • the first member 70, the second member 72 and the third member 74 are combined together to form the outer needle hub 68 as follows.
  • the first member 70 and the second member 72 are assembled by inserting the second member 72 into the first member 70 from the base end side. More specifically, the second member 72 is inserted between the pair of engaging portions 94a and 94b of the first member 70 facing each other from the proximal side in the axial direction. As a result, the valve holding portion 116 provided at the distal end of the second member 72 is inserted into the proximal end opening portion of the connecting tubular portion 76 of the first member 70, and as shown in FIGS. The engaging portions 94a and 94b of the first member 70 are inserted into the engaging grooves 114a and 114b of the projecting portions 110 and 112 of the second member 72 on both sides in the vertical direction.
  • first member 70 and the second member 72 are positioned relative to each other in the circumferential direction by being restricted by engagement between the portions 94a, 94b and the inner surfaces of the engagement grooves 114a, 114b.
  • the engaging portions 94a and 94b are inserted into the engaging grooves 114a and 114b, the contact between the engaging portions 94a and 94b and the inner surfaces of the side walls of the engaging grooves 114a and 114b causes the first member 70 and the second member 70 to move.
  • the member 72 is positioned in the left-right direction (width direction). Further, the first member 70 and the second member 72 are also positioned in the vertical direction by inserting the second member 72 between the facing surfaces of the pair of upper and lower engaging portions 94a and 94b. In short, by inserting the locking portions 94a and 94b into the locking grooves 114a and 114b, the first member 70 and the second member 72 are positioned not only in the circumferential direction but also in the radial direction. ing.
  • the upper engaging portion 94a is inserted into the engaging groove 114a of the projection 110 on the distal end side and the engaging groove 114a of the projecting portion 112 on the proximal end side.
  • the locking portion 94b on the lower side is inserted into the locking groove 114b of the projecting portion 110 on the distal end side and the locking groove 114b of the projecting portion 112 on the proximal end side.
  • the locking portion 94 is inserted into each locking groove 114 of the projecting portions 110 and 112 on both the distal end side and the proximal end side, so that the first member 70 and the second member 72 move in the circumferential direction. are positioned more stably in and are positioned relative to each other in the prying direction.
  • the peripheral wall portion of the second member 72 is partially thinned by forming the locking grooves 114a and 114b.
  • the locking grooves 114a and 114b may be formed directly on the peripheral wall portion of the second member 72 so as to open on the outer peripheral surface.
  • the base end surface of the connecting tube portion 76 of the first member 70 abuts against the projecting portion 110 on the distal end side of the second member 72 from the distal end side, so that the first member 70 and the second member 72 are axially connected to each other. is positioned at
  • the valve holding portion 116 of the second member 72 is inserted into the holding cylinder portion 102 of the valve body 98 disposed on the inner circumference of the connecting cylinder portion 76 of the first member 70, and the tip portion of the valve holding portion 116 is attached to the valve body. 98 is inserted into the holding groove 104 .
  • the valve body 98 is axially sandwiched between the stepped inner surface 82 of the first member 70 and the valve holding portion 116 of the second member 72, and the connecting cylinder portion 76 of the first member 70 is held. It is radially sandwiched between the inner peripheral surface and the outer peripheral surface of the valve holding portion 116 of the second member 72 , and positioned and held between the first member 70 and the second member 72 .
  • the pusher 128 arranged on the inner periphery of the second member 72 is positioned closer to the proximal side than the valve body 98 .
  • the third member 74 is attached to the first member 70 in an extrapolated state. That is, the third member 74 is externally inserted into the first member 70 from the distal end side, and as shown in FIGS. It is axially inserted into the notches 136a, 136b.
  • the locking portions 94a and 94b axially abut and lock the inner surfaces of the notches 136a and 136b, thereby restricting the distal movement of the first member 70 with respect to the third member 74.
  • the first member 70 and the third member 74 are axially positioned relative to each other.
  • a first member 70 and a third member 74 are circumferentially positioned relative to each other.
  • the third member 74 externally inserted on the first member 70 is overlapped with the axially extending portion of the outer peripheral surface of the connecting tube portion 76 of the first member 70 .
  • a tapered outer surface 86 is located on each side of the direction.
  • the third member 74 is displaced from the caulking pin 80 fixed to the first member 70 toward the base end side.
  • the caulking pin 80 and a valve body 98 which will be described later, are separated in the axial direction, and the tapered inner surface 78 can be formed on the proximal end side of the caulking pin 80, so that the diameter of the internal flow path 69 is rapidly expanded.
  • the connecting cylinder portion 76 of the first member 70 is deformed by the press-fitting of the crimping pin 80, the connecting cylinder portion 76 is not deformed at the base end side of the crimping pin 80 on which the distal end cover portion 132 of the third member 74 is superimposed. It is possible to accurately set the outer diameter of the
  • the vertical outer surfaces of the locking portions 94a and 94b inserted into the notches 136a and 136b of the third member 74 are positioned substantially on the same plane as the flat surfaces 134 and 134 of the third member 74.
  • planar portions 144, 144 extending substantially orthogonally to the vertical direction are provided on both sides of the outer peripheral surface of the outer needle hub 68, and the planar portions 144, 144 are engaged with each other. It is constituted by the upper and lower outer surfaces of the portions 94a and 94b and the flat surfaces 134 and 134 of the third member 74. As shown in FIG.
  • the outer needle hub 68 has a vertical outer dimension smaller than its lateral outer dimension.
  • the locking portions 94a and 94b of the first member 70 are inserted into the locking grooves 114a and 114b of the second member 72 and the notches 136a and 136b of the third member 74, thereby The outer dimension of the outer needle hub 68 in the vertical direction is reduced by suppressing the protrusion height of the outer peripheral side of the 94a and 94b.
  • the locking claws 118 , 118 of the second member 72 are inserted into the connecting holes 140 , 140 .
  • the engaging claws 118, 118 are pushed to the connecting holes 140, 140 by the guide inclined surfaces 120, 120 being pressed against the guide surfaces 142, 142 of the connecting pieces 138, 138 and expanding the gap between the connecting pieces 138, 138 facing each other. be guided.
  • the locking claws 118, 118 By locking the locking claws 118, 118 to the inner surfaces of the connecting holes 140, 140, the separation in the axial direction between the second member 72 and the third member 74 is restricted.
  • Three members 74 are interconnected.
  • the amount of movement of the first member 70 toward the proximal side with respect to the second member 72 is limited, and the amount of movement toward the distal side with respect to the third member 74 is limited.
  • the coupling of the three members 74 positions the second member 72 and the third member 74 axially on both sides. In this manner, the first member 70, the second member 72, and the third member 74 are positioned and connected to each other to form the outer needle hub 68, and the valve inside the outer needle hub 68. Body 98 and pusher 128 are contained.
  • the outer needle 66 fixed to the first member 70 is divided into the three members 70, 72. , 74 are fixedly connected to the outer needle hub 68 . Since the outer needle 66 and the outer needle hub 68 are directly fixed in this way, the outer needle hub 68 housing, for example, the valve element 98 and the filter 148 (described later) can be connected to the outer needle 66 via a tube or the like. Relative movement of the outer needle 66 and outer needle hub 68 is not permitted as compared to being indirectly attached to the .
  • the second member 72 and the third member 74 can be partially connected in the circumferential direction.
  • An engaging structure can be adopted in which the engaging claws 118, 118 of the second member 72 and the connecting holes 140, 140 of the third member 74 are provided. That is, when the first member 70, the second member 72, and the third member 74 are assembled in the axial direction, the locking portions 94a, 94b of the first member 70 are aligned with the locking grooves 114a, 114b of the second member 72 and the third member 74.
  • the positions can be easily aligned in the circumferential direction. can do. Therefore, the first member 70, the second member 72, and the third member 74 can be easily connected to form the outer needle hub 68 by the locking structure partially provided in the circumferential direction.
  • the third member 74 covers the opening of the ventilation recess 90 provided in the first member 70 at a remote position.
  • a housing area 146 is formed between the first member 70 and the third member 74 to communicate with the ventilation recess 90 .
  • the housing area 146 communicates with the external space through the overlapping surfaces of the first member 70 and the third member 74 . Therefore, the distal end side of the valve body 98 in the internal flow path 69 of the outer needle hub 68 is exposed to the external space through the air vent passage formed by the vent hole 92 composed of the vent groove 84 and the vent recess 90 and the housing area 146. are communicated.
  • a filter 148 that allows gas such as air to pass through and restricts liquid such as blood to pass through is arranged in the housing area 146 .
  • a filter 148 includes, for example, a water-absorbent polymer, and permits the passage of gas such as air, while absorbing liquid such as blood to restrict the passage of the liquid and form a substantially sealed state.
  • the accommodation area 146 has a wall surface formed by the outer peripheral surface and the stepped outer surface 88 of the connecting tube portion 76 of the first member 70, the inner peripheral surface of the third member 74, and the tip cover portion 132. Filters 148 are suitably compressed radially and/or axially by the walls of these receiving areas 146 .
  • filter 148 is sandwiched between first member 70 and third member 74 .
  • the filter 148 is disposed on the air vent passage that communicates the distal end side of the internal flow path 69 of the outer needle hub 68 with the external space from the valve element 98 of the internal flow path 69, the valve element 98 of the internal flow path 69 While air is allowed to be discharged from the distal end side to the external space, leakage of blood from the distal end side of the internal flow path 69 relative to the valve body 98 to the external space is suppressed.
  • the first member 70 and the third member 74 are superimposed in a contact state or a close proximity state, so that when blood passes between the overlapping surfaces of the first member 70 and the third member 74, , a relatively large flow resistance is exhibited, and leakage of blood or the like is more effectively suppressed.
  • the outer needle hub 68 has a structure in which three members (a first member 70, a second member 72 and a third member 74) are combined. Sandwiching the valve body 98 and the filter 148 to the outer needle hub 68 can be easily assembled. Further, since the first member 70, the second member 72, and the third member 74 are positioned relative to each other, the inner peripheral side of the first member 70 is sandwiched between the first member 70 and the second member 72. The valve body 98 is stably attached to the outer needle hub 68, and the filter 148 sandwiched between the first member 70 and the third member 74 on the outer peripheral side of the first member 70 is attached to the outer needle. It is stably attached to the hub 68 .
  • the valve body 98 and the filter 148 can be easily assembled to the outer needle hub 68 while being stably held.
  • the size of the outer needle unit 10 can be reduced.
  • the outer needle as the valve housing is Since the needle hub 68 is directly fixed to the outer needle 66 without a tube, the axial dimension of the outer needle unit 10 can be reduced.
  • the outer needle unit 10 is configured by inserting and fixing the base end portion of the outer needle 66 to the first member 70 of the outer needle hub 68 having such a structure.
  • the inner lumen 67 of the outer needle 66 communicates with the inner channel 69 of the outer needle hub 68 .
  • the internal flow path 69 of the outer needle hub 68 is blocked by a valve body 98, and the distal end side of the valve body 98 is communicated with the external space by an air vent passage configured to include a vent hole 92 and a housing area 146.
  • the base end side of the valve body 98 communicates with the external space through the base end opening of the second member 72 .
  • the outer needle unit 10 constitutes an indwelling needle assembly 12 by being combined with the inner needle unit 14 . That is, the inner needle 16 of the inner needle unit 14 is inserted into the outer needle unit 10 from the proximal side, penetrates the outer needle unit 10, and protrudes from the outer needle 66 to the distal side. By inserting and fitting the inner needle hub 22 of the inner needle unit 14 into the base end opening of the second member 72 of the outer needle unit 10, the inner needle unit 14 and the outer needle unit 10 are connected to each other. Thus, an indwelling needle assembly 12 is constructed. In addition, in the indwelling needle assembly 12 , the inner needle 16 penetrates through the slit 100 to the distal side of the valve body 98 .
  • the positioning projection 46 provided in the housing 36 of the outer needle unit 10 and the contact portion of the operation button 52 are inserted. 62 are inserted.
  • the units 10 are circumferentially positioned relative to each other. This defines the relative orientation of the blade surface 20 of the inner needle 16 and the planar portions 144, 144 of the outer needle hub 68 in the circumferential direction.
  • the base end portion of the second member 72 is inserted below the contact portion 62 of the operation button 52 in the bottom wall portion of the positioning groove 108 on the upper side.
  • the indwelling needle assembly 12 is used, for example, when indwelling the patient's blood vessel with the outer needle unit 10 as an indwelling needle.
  • the inner needle 16 inserted into the outer needle 66
  • the inner needle 16 and the outer needle 66 are punctured into the patient's blood vessel.
  • the inner needle unit 14 is pulled out from the outer needle unit 10 toward the proximal side.
  • the outer needle unit 10 is left in a state of being punctured into the blood vessel, and, for example, by connecting an artificial dialysis circuit to the proximal end opening of the second member 72 of the outer needle unit 10, the outer needle unit 10 can be removed. It can be used as a blood outlet.
  • the operation surface 96 of the upper engaging portion 94a exposed to the external space can be used to perform the dispensing operation. That is, when pulling out the inner needle unit 14 from the outer needle unit 10 , the user presses the index finger or middle finger of the hand holding the inner needle unit 14 against the operation surface 96 of the locking portion 94 to pull the outer needle unit 10 out. Pay out to the tip side. As a result, when the inner needle unit 14 is pulled out to the proximal side, it is possible to prevent the outer needle unit 10 from moving to the proximal side together with the inner needle unit 14 and slipping out of the blood vessel.
  • the operation surface 96 which is the input point for the dispensing operation, is the base end surface of the first member 70 directly fixed to the outer needle 66, the force applied during the dispensing operation is efficiently applied to the outer needle 66. Therefore, it is possible to prevent the outer needle 66 from slipping out of the blood vessel.
  • the operation surface may be provided on the second member 72 and/or the third member 74. In this case also, the second member 72 and the third member 74 are positioned with respect to the first member 70. Since the amount of relative displacement is limited to the extent that the first member 70 and the first member 70 can be regarded as being substantially integrated, the operating force can be efficiently transmitted to the outer needle 66 .
  • the inner needle 16 is pulled out from the slit 100 of the valve body 98, and the slit 100 of the valve body 98 is closed, thereby preventing blood from leaking to the proximal side.
  • the tip side (internal space of the first member 70) of the internal flow path 69 of the outer needle hub 68 from the valve body 98 communicates with the external space via an air vent passage including the vent hole 92 and the housing area 146.
  • air is pushed out by the blood flowing into the internal flow path 69 on the distal side of the valve body 98 , and the internal flow path 69 on the distal side of the valve body 98 is filled with blood.
  • the blood that fills the internal flow path 69 on the distal side of the valve element 98 is prevented from leaking into the external space by the filter 148 arranged in the containing area 146 .
  • An external circuit such as an artificial dialysis circuit is connected to the indwelling outer needle unit 10 .
  • the external circuit is connected to the proximal opening of second member 72 and secured to outer needle hub 68 by, for example, threaded portion 106 of second member 72 .
  • the pusher 128 is pushed forward, the pusher 128 is inserted into the slit 100 of the valve body 98, and the slit 100 of the valve body 98 is pushed open by the pusher 128. be done.
  • the internal flow path 69 of the outer needle hub 68 is switched to a communication state in which the internal flow path 69 of the outer needle hub 68 is penetrated in the axial direction without being blocked by the valve body 98 , and the external circuit is connected to the internal flow path 69 of the outer needle hub 68 and the outer needle 66 . It communicates with the inside of the blood vessel through the lumen 67 of the.
  • the valve body 98 has a function of switching between blocking and communication of the internal flow path 69 of the outer needle hub 68 .
  • valve body 98 deformed by the pusher 128 closes the opening of the ventilation groove 84 toward the inner peripheral side, the air bleeding passage including the ventilation groove 84 is blocked by the valve body 98, and the air bleeding passage is closed. leakage of blood through the is prevented.
  • the vertical direction in which the outer diameter of the outer needle hub 68 is small is the overlapping direction with respect to the patient's body surface. Therefore, the force exerted by the contact of the outer needle hub 68 to the patient is reduced, the pain and discomfort caused by the strong pressing of the outer needle hub 68 against the patient is reduced, and the outer needle 66 is applied to the patient. It also reduces pain and discomfort caused by applying force to the puncture site.
  • the locking portions 94a and 94b are more likely to be accommodated in the inner periphery of the third member 74, for example.
  • the outer diameter dimension in the vertical direction where the engaging portions 94a and 94b are provided can be reduced.
  • the outer surfaces of the engaging portions 94a and 94b in the vertical direction are not convex curved surfaces toward the outer periphery but are flat surfaces, and the outer surfaces of the third member 74 corresponding to the engaging portions 94a and 94b in the vertical direction are flat. are flat surfaces 134, 134, and flat portions 144, 144 are provided on both upper and lower sides of the outer peripheral surface of the outer needle hub 68, so that the outer dimension of the outer needle hub 68 in the vertical direction can be made smaller. ing.
  • the surface of the outer needle hub 68 that contacts the patient is the planar portion 144, so that the contact area of the outer needle hub 68 with the patient's body surface can be increased. can. As a result, the force acting on the patient due to the contact of the outer needle hub 68 is dispersed, and pain and discomfort caused by the contact of the outer needle hub 68 are reduced.
  • a first member 70 directly fixed to the outer needle 66, and a second member 72 and a third member 74 connected to the first member 70 are positioned relative to each other in the circumferential direction, and the amount of relative rotation is adjusted. Limited. Therefore, an adverse effect on the holding state of the valve body 98 and the filter 148 due to the relative rotation of the members 70, 72, 74 is prevented, and inadvertent rotation of the first member 70 having the outer needle 66 is prevented. It is also possible to block it with the third member 74 or the like.
  • the outer needle 66 may be twisted, or force may be applied to the puncture portion of the outer needle 66, causing pain or discomfort to the patient. It is possible to prevent problems such as giving a pleasant feeling.
  • the inner needle unit 14 that is pulled out and separated from the outer needle unit 10 can operate the safety mechanism by pressing the operation button 52 . That is, when the inner needle unit 14 moves from the outer needle unit 10 toward the proximal end side, the proximal end portion of the second member 72 moves from below the contact portion 62 of the operation button 52 and moves downward from the operation button 52 . Movement is no longer hindered by the proximal end of the second member 72 .
  • the operating button 52 is pushed downward, the engaging projection 58 of the operating button 52 is pulled out of the engaging recess 34 of the inner needle hub 22, thereby axially positioning the inner needle hub 22 with respect to the housing 36. be released.
  • the elastic restoring force of the coil spring 64 arranged in a compressed state moves the inner needle hub 22 toward the proximal end side with respect to the housing 36, and the inner needle 16 fixed to the inner needle hub 22 moves toward the housing.
  • 36 is housed inside. Since the entire inner needle 16 is accommodated in the housing 36 without the needle tip 18 protruding beyond the housing 36, the needle tip 18 of the inner needle 16 is prevented from accidentally being touched, thereby preventing erroneous puncture. It is possible to avoid problems such as
  • the present invention is not limited by the specific descriptions.
  • the structure in which the first member 70 is provided with the pair of locking portions 94a and 94b is described, but the number of the locking portions 94 may be only one.
  • one locking groove 114 of the second member 72 and one notch 136 of the third member 74 are also provided at positions corresponding to the locking portions 94 .
  • three or more of each of the locking portions 94, the locking grooves 114, and the notches 136 may be provided.
  • the outer needle hub 68 of the above-described embodiment has a generally cylindrical outer peripheral surface as a whole.
  • the outer peripheral surface of the outer needle hub 68 into an elliptical cylindrical shape, the outer dimension in the vertical direction can be made smaller than the outer dimension in the horizontal direction.
  • outer needle hubs having different outer dimensions in two orthogonal radial directions vertical direction and lateral direction
  • a flexible It is also possible to combine a structure in which the outer needle and the outer needle hub are indirectly connected via the tube without directly fixing the outer needle and the outer needle hub.
  • the hub fixed to the base end portion of the outer needle and the first member of the outer needle hub with a tube, it is possible to allow relative displacement of the outer needle hub with respect to the outer needle.
  • the contact pressure is reduced by the flexibility of the tube. Effects and the like can also be obtained.
  • the planar portion 144 is desirably provided using the locking portion 94, but can also be configured without the locking portion 94.
  • the lower planar portion 144 may be configured only by the lower flat surface 134 of the third member 74. is also possible.
  • the operation surface is not limited to a stepped surface as in the above embodiment, and may be, for example, a projecting surface that protrudes outward from the outer peripheral surface of the valve housing.
  • a display may be provided on the top of the valve housing so that the user can easily grasp the vertical direction of the valve housing.
  • the user can confirm the display part at the time of puncture, thereby indicating the inner needle.
  • the direction of the blade surface can be vertically upward.
  • the structure of the display unit is not particularly limited as long as the user can visually or tactilely confirm the orientation of the valve housing. , company logo printing, etc.
  • the operating surface may be partially provided in the circumferential direction so that the operating surface functions as a display section.
  • the outer periphery of the valve housing may be configured with different surface shapes.
  • outer needle unit (needle assembly) 12 Indwelling needle assembly 14 Inner needle unit 16 Inner needle 18 Needle tip 20 Blade surface 22 Inner needle hub 24 Stepped surface 26 Small diameter portion 28 Large diameter portion 30 Ridge portion 32 Guide protrusion 34 Engaging concave portion 36 Housing 38 Housing body 40 Cap 42 Insertion hole 44 Surrounding projection 46 Positioning projection 48 Guide groove 50 Through hole 52 Operation button 54 Base portion 56 Annular portion 58 Engagement projection 60 Lock projection 62 Contact portion 64 Coil spring 66 Outer needle 67 Inner cavity 68 Outside needle hub (valve housing) 69 Internal flow path 70 First member 72 Second member 74 Third member 76 Connecting tube portion 78 Taper inner surface 80 Crimping pin (fixing member) 82 Stepped inner surface 84 Ventilation groove 86 Tapered outer surface 88 Stepped outer surface 90 Vent recess 92 Vent hole (air vent passage) 94 Locking portion 96 Operation surface 98 Valve body 100 Slit 102 Holding cylinder portion 104 Holding groove portion 106 Threaded portion 108 Positioning groove 110 Protrud

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PCT/JP2022/039995 2021-10-26 2022-10-26 針組立体 Ceased WO2023074756A1 (ja)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5290246A (en) * 1991-01-18 1994-03-01 Terumo Kabushiki Kaisha Piercing needle
JP2013070870A (ja) * 2011-09-28 2013-04-22 Terumo Corp カテーテル組立体
WO2019146791A1 (ja) * 2018-01-26 2019-08-01 ニプロ株式会社 ハブ組立体

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5290246A (en) * 1991-01-18 1994-03-01 Terumo Kabushiki Kaisha Piercing needle
JP2013070870A (ja) * 2011-09-28 2013-04-22 Terumo Corp カテーテル組立体
WO2019146791A1 (ja) * 2018-01-26 2019-08-01 ニプロ株式会社 ハブ組立体

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