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WO2015125923A1 - Medical connector and method of manufacturing medical connector - Google Patents

Medical connector and method of manufacturing medical connector Download PDF

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Publication number
WO2015125923A1
WO2015125923A1 PCT/JP2015/054810 JP2015054810W WO2015125923A1 WO 2015125923 A1 WO2015125923 A1 WO 2015125923A1 JP 2015054810 W JP2015054810 W JP 2015054810W WO 2015125923 A1 WO2015125923 A1 WO 2015125923A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
ring member
valve body
elastic valve
convex portion
Prior art date
Application number
PCT/JP2015/054810
Other languages
French (fr)
Japanese (ja)
Inventor
裕之 中神
慎吾 阪本
Original Assignee
二プロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 二プロ株式会社 filed Critical 二プロ株式会社
Priority to JP2016504189A priority Critical patent/JP6399317B2/en
Publication of WO2015125923A1 publication Critical patent/WO2015125923A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0072Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M2039/229Stopcocks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production

Definitions

  • the present invention relates to a medical connector that enables connection of a medical connector (male connector) to an infusion route and the like, and a method of manufacturing the same, when performing mixed injection of chemical liquids or collection of body fluids using the infusion route. It is.
  • a male connector such as a luer tip at the tip of a syringe
  • an infusion route for infusion or blood collection in order to mix medicinal fluids or collect body fluids using the infusion route.
  • a medical connector is provided.
  • an infusion route such as an infusion is formed using a pair of three openings, and a male connector can be connected to the remaining one opening.
  • a so-called split septum type connector described in JP-T-2-502976 (Patent Document 1) is known.
  • the split septum type medical connector has a structure with a disc-shaped elastic valve body in the opening. By inserting the tip of the male connector directly into the slit of the elastic valve body and pushing the slit open, Enables internal communication between the route and male connector.
  • the outer end of the elastic valve body is sandwiched in the axial direction by bending the open end of the housing to the inner periphery by swaging or the like. ing.
  • the elastic valve body may be attached to the housing in an inclined manner because the deformation amount of the opening end of the housing varies on the circumference.
  • Patent Document 2 Japanese Patent Application Laid-Open No. 2009-11820
  • the applicant uses a separate ring member to be inserted into the opening of the housing, so that the ring member and the pedestal of the housing A structure is proposed in which an elastic valve body is sandwiched between and supported.
  • the housing opening is bent and the ring member is pushed in until the upper surface of the ring member and the upper surface of the central portion of the elastic valve body are located on the same plane.
  • the positional relationship of each member may vary, and a means for positioning with higher accuracy has been demanded.
  • the present invention has been made in the background of the above-described circumstances, and the problem to be solved is an improvement in which the elastic valve body can be attached to the housing in a substantially constant state with little variation. It is to provide a medical connector and a manufacturing method thereof.
  • the first aspect of the present invention is a method of manufacturing a medical connector, which is made of a thermoplastic resin having an opening in which a valve seat for supporting an outer peripheral portion of a disk-like elastic valve body is formed.
  • a step of supporting the elastic valve body by the valve seat of the housing and setting the opening in the opening, and overlapping the ring member on the housing in which the elastic valve body is set In the melting step of melting the welding projection protruding from the overlapping surface of the housing and the ring member, and in the melting state of the welding projection in the melting step, the welding projection is crushed and the how By pressing the housing and the ring member in the approaching direction until the contact area of the overlapping surface of the ring and the ring member increases, the housing and the ring member are integrally connected and fixed by the welding convex portion, And a valve body fixing step of clamping the outer peripheral portion of the elastic valve body with the ring member and the valve seat of the housing.
  • the welding convex portion provided between the housing and the ring member is melted and the housing and the ring member are fixed, Compared to the method, melting variations are less likely to occur, and a situation in which pressure is applied unevenly to the elastic valve body is less likely to occur. Furthermore, since the welding convex portion is easy to melt, it is easy to push in. However, when the welding convex portion is completely melted, the surfaces of the housing and the ring member come into contact with each other, making it difficult to push in. For this reason, advanced control / adjustment is not required, and variations are much less likely to occur than in the past.
  • the housing and the ring member are integrally connected and fixed together by melting the welding convex portion, so that the welding convex portion protrudes on the overlapping surface of the housing and the ring member, and the housing and the ring member are strengthened.
  • the elastic valve body can be stably supported by fixing.
  • the length from the overlapping surface to the tip end portion is uniform in the overlapping surface of the housing and the ring member.
  • the formed welding convex portion is provided continuously over the entire circumference or intermittently in the circumferential direction.
  • the contact portion of the welding convex portion is provided in an annular shape in the circumferential direction, and the housing and the ring member are integrally connected and fixed over the entire circumference, thereby further strengthening the housing and the ring member.
  • Adherence can be realized. Furthermore, by fixing the housing and the ring member continuously over the entire circumference, stress can be prevented from concentrating on the circumferential end of the fixed portion, and the problem that the ring member is peeled off from the housing more reliably. Can be prevented. Further, since it is possible to prevent pressure from being applied unevenly to the elastic valve body, it is difficult to cause positional displacement of the elastic valve body after fixing, and it is possible to more reliably prevent a problem that the ring member is peeled off from the housing.
  • an annular recess that opens in the inner and outer surfaces of the outer peripheral portion and extends in the circumferential direction is provided.
  • the structure of the valve seat provided with an annular convex portion inserted into the annular concave groove provided on the inner surface of the elastic valve body as the housing.
  • the ring member a structure in which an annular convex portion to be inserted into the annular concave groove provided on the outer surface of the elastic valve body is adopted, and in the valve body setting step, the annular shape of the inner surface of the elastic valve body is adopted.
  • the annular convex portion of the valve seat of the housing is inserted into the concave groove and set, and in the melting step and the valve body fixing step, the annular concave groove on the outer surface of the elastic valve body is The annular convex part of the ring member By then put are those fitted by pushing the respective annular protrusions for each annular groove of the inner and outer surfaces of the elastic valve body.
  • the elastic valve body is set in a state where it is positioned to some extent in the opening of the housing by inserting the annular convex portion of the housing into the annular concave groove on the inner surface of the elastic valve body in the valve body setting step. It is possible to facilitate the manufacturing work in the melting step and the valve body fixing step.
  • the melting step and the valve body fixing step In this case, when the housing and the ring member are pressed in the approaching direction, relative displacement between the housing and the ring member is unlikely to occur. Furthermore, by fixing the housing and the ring member and inserting and fitting the respective annular convex portions into the respective annular concave grooves on the inner and outer surfaces, the annular convex portion is locked to the inner surface of the annular concave groove and the elastic valve.
  • the body can be positioned relative to the housing and the ring member. Accordingly, the housing, the ring member, and the elastic valve body can be positioned with respect to each other not only in the approaching direction but also in the direction orthogonal thereto, and can be fixed with high accuracy.
  • a fourth aspect of the present invention there is provided the method for manufacturing a medical connector according to any one of the first to third aspects, wherein the housing and the ring member are overlapped in the melting step.
  • the contact portion of the welding convex portion is melted by applying ultrasonic vibration.
  • the fourth aspect it is relatively easy to selectively melt only the contact portion of the welding convex portion by adjusting the frequency and the output, and the housing and the portion at the portion where the welding convex portion is removed. While the ring member is positioned by contact, the housing and the ring member can be fixed at the contact portion of the welding convex portion.
  • a fifth aspect of the present invention is the method for manufacturing a medical connector according to any one of the first to fourth aspects, wherein the ring member is inserted into the opening of the housing.
  • a structure provided with a fitting convex portion that is positioned in the radial direction with respect to the inner peripheral surface of the opening of the housing is adopted, and the fitting convexity of the ring member is used in the melting step and the valve body fixing step.
  • the welding convex portion is melted in a state where the portion is inserted into the opening of the housing.
  • a housing and a ring member can be welded, positioning a ring member with respect to the opening part of a housing by inserting the fitting convex part of a ring member in the opening part of a housing. . Therefore, it is possible to prevent the relative displacement between the housing and the ring member not only in the approaching direction but also in the radial direction, and to connect and fix the housing and the ring member with high accuracy in the relative positional relationship of interest. it can.
  • the molten resin (weld) is melted inside the housing when the welding convex portion is melted. Intrusion into the circumferential side can be prevented, and deterioration of the elastic valve body due to contact with the heated resin is prevented.
  • the molten resin is filled in the minute gaps between the mating projections and the overlapping surfaces of the housing, an improvement in the fixing strength between the housing and the ring member can be expected.
  • a sixth aspect of the present invention is a medical connector in which a disc-shaped elastic valve body is assembled to an opening of a housing, and an outer peripheral portion of the elastic valve body is supported by the housing, A valve seat for supporting the inner surface of the outer peripheral portion of the elastic valve body is formed in the opening of the housing, and a ring member is superimposed on the outer surface of the outer peripheral portion of the elastic valve body, The outer peripheral portion of the elastic valve body is sandwiched between the valve seat and the ring member by directly adhering the housing and the ring member around, and the housing and the ring member In the fixing portion, the welding convex portion protruding between the overlapping surfaces of the housing and the ring member is melted to provide a welding portion, and the portion that is out of the welding convex portion between the overlapping surfaces is provided. That positioning portion for positioning said housing and said ring member in the approaching direction are provided mutually in contact, characterized.
  • the overlapping surface of the housing and the ring member is integrally connected and fixed at the welded portion where the welded convex portion is melted. At the same time, they are brought into contact with each other at the positioning portion which is a portion where the welding convex portion is removed.
  • the relative position of the approaching direction of the housing and the ring member can be set with high accuracy while realizing the firm fixation of the housing and the ring member. Accordingly, the outer peripheral portion of the elastic valve body is sandwiched excessively between the housing and the ring member, and the durability and deformation characteristics (spring constant) of the target elastic valve body can be stably and effectively obtained.
  • abutting of the overlapping surface in a positioning part may be direct, and may be indirect via a welding convex part. That is, if the welding convex part is completely melted without substantially remaining, and the peripheral part including the welding convex part is positioned so that the housing and the ring member abut each other with a surface larger than the welding convex part. good.
  • the ring member is engaged with the housing, and the welding convex portion is formed after the housing and the ring member are overlapped with each other.
  • the guide part which guides the movement of the said housing until the part which remove
  • the housing and the ring member when the housing and the ring member are welded, the housing and the ring member are moved closer to each other while being guided by the guide portion, thereby preventing the housing and the ring portion from being displaced from each other at an appropriate position. It is fixed.
  • the welded portion is continuously formed over the entire circumference in the circumferential direction of the housing.
  • the positioning portion is provided at a position where the welded portion deviates in the radial direction.
  • the housing and the ring member can be firmly and stably fixed on the circumference.
  • the elastic valve body is stably sandwiched between the members. Furthermore, by providing the positioning portion at a position where the welded portion is deviated in the radial direction, the positioning portion can be continuously provided over the entire circumference, and the housing and the ring member are fixed in a relatively inclined state. And the elastic valve body can be held more stably.
  • the medical connector according to any one of the sixth to eighth aspects, wherein the ring member is inserted into the opening of the housing.
  • a fitting convex portion that is positioned in the radial direction with respect to the inner peripheral surface of the opening is provided.
  • the housing and the ring member are positioned in the radial direction by inserting the fitting convex portion into the opening of the housing, the positional deviation in the radial direction of the housing and the ring member is prevented. Can be prevented.
  • the outer peripheral surface of the fitting convex portion has a shape corresponding to the inner peripheral surface of the opening portion of the housing, and the outer peripheral surface of the fitting convex portion is overlapped with the inner peripheral surface of the opening portion of the housing over the entire circumference.
  • the molten resin of the welding convex portion is prevented from entering the inner peripheral side of the housing by being blocked by the fitting convex portion.
  • the fixing strength between the housing and the ring member can be improved.
  • a ring member preparing step of preparing a ring member made of a thermoplastic resin that is attached to the opening and sandwiches an outer peripheral portion of the elastic valve body with the valve seat; and the elastic valve body as the ring member A valve body setting step for setting, a melting step for superimposing the housing on the ring member on which the elastic valve body is set, and melting a welding convex portion protruding from the overlapping surface of the housing and the ring member; Under the molten state of the welding protrusion in the melting step, the welding protrusion is crushed and the housing and the ring member are in contact with each other until the contact area between the overlapping surfaces of the housing and the ring member increases.
  • the housing member and the ring member are integrally connected and fixed by the welding convex portion by pressing the housing member in the approaching direction, thereby holding the outer peripheral portion of the elastic valve body by the valve seat of the housing and the ring member. And a valve body fixing step.
  • the welded convex portion melts substantially uniformly, so that the elastic valve body sandwiched between the housing and the ring member Uneven pressure is unlikely to be applied, and the housing and the ring member are positioned in the approaching direction by increasing the contact area of the overlapping surface, thereby preventing excessive pressing. Further, by fixing the ring member on which the elastic valve body is set to the housing, the elastic valve body is inserted into the housing, so that the attachment of the valve body to the housing becomes easier.
  • the annular convex portion restricts the outer peripheral end portion of the elastic valve body from bulging and deforming toward the inner peripheral side.
  • the area between the elastic valve body, the housing, and the ring member is sealed at the outer peripheral portion rather than the recess without requiring a special seal member.
  • the perspective view of the medical connector as one Embodiment of this invention.
  • the front view of the medical connector shown in FIG. The longitudinal cross-sectional view of the medical connector shown in FIG.
  • the perspective view of the housing which comprises the medical connector shown in FIG.
  • the front view of the housing shown in FIG. The longitudinal cross-sectional view of the housing shown in FIG.
  • the perspective view of the elastic valve body which comprises the medical connector shown in FIG.
  • the front view of the elastic valve body shown in FIG. The longitudinal cross-sectional view of the elastic valve body shown in FIG.
  • the perspective view of the ring member which comprises the medical connector shown in FIG.
  • the front view of the ring member shown in FIG. The longitudinal cross-sectional view of the ring member shown in FIG.
  • FIG. 14 is a cross-sectional perspective view illustrating a manufacturing process of the medical connector shown in FIG. 13.
  • the front view explaining the manufacturing process of the medical connector shown in FIG. The longitudinal cross-sectional view explaining the manufacturing process of the medical connector shown in FIG.
  • the longitudinal cross-sectional view which expands and shows the principal part in the manufacturing process of the medical connector shown in FIG. The perspective view of a three-way cock provided with the medical connector shown in FIG.
  • FIG. 1 to 3 show a medical connector 10 as an embodiment of the present invention.
  • the medical connector 10 has a structure in which an elastic valve body 14 having a disk shape is assembled in a central hole of a housing 12 having a cylindrical shape, and an outer peripheral portion of the elastic valve body 14 is supported by the housing 12. .
  • the vertical direction means the vertical direction in FIG. 2 unless otherwise specified. 1 to 20 show the same embodiment, but are appropriately enlarged or reduced for ease of viewing.
  • the housing 12 has a stepped cylindrical shape in which a large diameter cylindrical portion 16 and a small diameter cylindrical portion 18 are integrally formed as shown in FIGS.
  • the inner diameter dimension of the small-diameter cylindrical portion 18 is such that at least the opening 20 (the upper opening in FIG. 6) can accommodate the elastic valve element 14, and the slit 50 (described later) after the male connector is removed is resealed. Is preferably made substantially equal to the outer diameter dimension of the elastic valve body 14 so that is stably expressed.
  • the housing 12 is preferably formed of a material having a strength capable of reliably holding the elastic valve body 14, and specifically, a thermoplastic resin such as polypropylene, polyethylene, polyvinyl chloride, polycarbonate, polystyrene, polyacetal, or the like. Is exemplified.
  • the housing 12 is molded from these materials by injection molding or the like.
  • annular valve seat 22 that protrudes radially inward is integrally formed on the small diameter cylindrical portion 18, and the inner peripheral edge of the valve seat 22 is formed outwardly in the opening direction of the small diameter cylindrical portion 18 (
  • a locking convex portion 24 is integrally formed as an annular convex portion projecting upward.
  • the locking projection 24 has a peripheral wall shape that is continuous over the entire circumference with a constant protrusion height dimension, and an annular fitting groove 26 is formed by the valve seat 22 and the locking projection 24. , Opening toward the opening 20 of the housing 12.
  • a portion extending from the inner peripheral surface of the locking convex portion 24 to the inner peripheral surface of the valve seat 22 is a contact inner peripheral surface 28 that extends over the entire circumference in the circumferential direction with a curved convex shape. ing.
  • a male screw portion 30 into which a female screw portion 106 of the luer lock connector 102 described later is screwed is formed.
  • the male threaded portion 30 is preferably a female threaded portion of the luer lock connector 102 stipulated by ISO 594, in which the peak diameter of the screw is set to 7.0 ⁇ 0.2 mm and the root diameter of the screw is set to 8.0 ⁇ 0.1 mm. This is a double thread that can be connected to 106.
  • the outer diameter of the housing 12 is such that the standard luer tip 104 defined in ISO 594 can be connected. Is preferably set within a range of 6.0 to 7.0 mm.
  • the outer diameter of the small-diameter cylindrical portion 18 including a thread is provided. Is preferably set within a range of 7.0 to 8.0 mm.
  • the opening end surface 32 which is an axial direction end surface at the side of the small-diameter cylindrical portion 18 of the housing 12 is an annular flat surface having a substantially constant width dimension and continuing to the entire circumferential direction, and spreads in a direction substantially perpendicular to the axis.
  • the elastic valve body 14 includes a disc-shaped central portion 34 having a substantially constant thickness dimension, and a substantially annular ring surrounding the outer periphery of the central portion 34 over the entire circumference.
  • An annular fixing portion 36 having a shape is integrally provided, and is substantially disk-shaped as a whole.
  • the elastic valve body 14 is formed of a material having elasticity, and is made of a material such as isoprene rubber or silicone rubber selected from synthetic rubber, natural rubber, thermoplastic elastomer and the like in consideration of airtightness and resealability. Is formed by press molding, molding, or the like.
  • the annular fixing portion 36 continuously extends in the circumferential direction with a certain substantially rectangular cross-sectional shape.
  • the rectangular cross section has an axial dimension (vertical dimension in FIG. 9) larger than a radial dimension (horizontal dimension in FIG. 9).
  • the axial dimension of the annular fixing portion 36 is smaller than the axial dimension of the central portion 34, and the axial upper end surface of the annular fixing portion 36 is inward of the axial upper end surface of the central portion 34 (see FIG. 9) (lower part of 9). This prevents the center portion 34 from protruding upward in the axial direction relative to the ring member 52 when a ring member 52 described later is superimposed on the upper side in the axial direction of the annular fixing portion 36.
  • the inner annular groove 42 is formed on the inner surface 38 of the elastic valve body 14, and the outer annular groove 44 is formed on the outer surface 40.
  • the inner and outer annular grooves 42 and 44 are continuous over the entire circumference with a substantially constant concave cross section, and are formed at substantially the same position in the radial direction of the elastic valve body 14. As a result, the thickness of the elastic valve body 14 is reduced at the portions where the inner and outer annular concave grooves 42 and 44 are formed, and the central portion 34 constituting the inner peripheral portion of the elastic valve body 14 and the annular portion constituting the outer peripheral portion.
  • a constricted portion 46 that connects the fixed portion 36 is formed.
  • constricted portion 46 is formed at a position slightly closer to the inner surface 38 in the thickness direction of the elastic valve body 14, and the central portion 34 of the elastic valve body 14 has an inner surface 38 on the outer surface 40 side than the constricted portion 46.
  • the axial dimension is larger than the side.
  • a concave groove portion 48 that continuously extends over the entire circumference with a curved concave sectional shape is formed.
  • a concave groove 48 is opened in the side wall surface.
  • the diameter of the central portion 34 of the elastic valve element 14 is preferably set within a range of 5.0 to 6.5 mm. If the diameter of the central portion 34 of the elastic valve body 14 is smaller than 5.0 mm, it becomes difficult to insert the luer tip 104 of the standard luer lock connector 102 whose outer diameter is unified to approximately 4.0 mm. Is larger than 6.5 mm, the outer diameter of the third branch opening 90 becomes large, and it becomes difficult to connect the female thread portion 106 of the standard luer lock connector 102.
  • the thickness dimension of the central portion 34 of the elastic valve body 14 is preferably set within a range of 1.0 to 3.0 mm. If the thickness dimension of the central part 34 is smaller than 1.0 mm, the sealing performance at the time of insertion of a male connector such as a syringe tip may be insufficient, while the thickness dimension is larger than 3.0 mm. This is because the insertion resistance of the male connector increases and the insertion operation may become difficult.
  • a slit 50 penetrating in the thickness direction is formed.
  • the shape of the slit 50 for example, a linear shape or a radial shape such as a cross is adopted.
  • the slit 50 has a length that does not reach the outer peripheral edge from the center of the central portion 34 in the radial direction 3. Radial shape extending in the direction.
  • the slit 50 is formed by, for example, passing a sharp blade in the thickness direction of the molded elastic valve body 14.
  • the slit 50 is in a cut-off state in which the inner surfaces are in close contact with each other based on the elasticity of the elastic valve body 14 in a mounted state of the elastic valve body 14 to be described later, thereby ensuring airtightness.
  • the elastic valve body 14 is set in the opening 20 of the housing 12 by being inserted into the opening 20 of the housing 12 and the inner surface of the annular fixing portion 36 being supported by the valve seat 22. Further, the elastic valve body 14 is prevented from being detached from the housing 12 by a ring member 52 fixed to the opening 20 of the housing 12.
  • the ring member 52 is a hard member formed of a thermoplastic resin, and is continuous with a substantially constant cross-sectional shape in the circumferential direction as shown in FIGS. Further, the ring member 52 has an inner periphery holding portion 54 having an outer diameter dimension substantially the same as the inner diameter dimension of the opening 20 of the housing 12 and an outer periphery having an outer diameter dimension substantially the same as the outer diameter dimension of the opening end surface 32 of the housing 12.
  • the fixing portion 56 is integrally provided.
  • a fitting convex portion 58 is provided on the inner peripheral clamping portion 54 of the ring member 52.
  • the fitting convex portion 58 has a substantially constant cross-sectional shape and continuously extends over the entire circumference, protrudes below the lower surface of the outer peripheral fixing portion 56 and forms a step with the outer peripheral fixing portion 56.
  • the outer diameter dimension is substantially the same as the inner diameter dimension of the opening 20 of the housing 12.
  • the outer peripheral surface of the annular fitting convex portion 58 is a substantially cylindrical surface extending in the axial direction, and is formed with an outer diameter that is substantially the same as the inner diameter of the opening 20 of the housing 12.
  • the outer peripheral edge portion of the projecting tip of the fitting convex portion 58 is tapered so as to gradually incline toward the projecting tip, and the projecting tip portion of the fitting convex portion 58 is tapered.
  • the protruding tip of the fitting projection 58 is smaller in diameter than the inner diameter of the opening 20 of the housing 12.
  • annular convex portion 60 is provided on the inner peripheral clamping portion 54 of the ring member 52.
  • the annular convex portion 60 is provided on the inner peripheral edge portion of the ring member 52, protrudes below the fitting convex portion 58, and has a cross-sectional shape that can be inserted into the outer annular concave groove 44 of the elastic valve body 14 in the circumferential direction. It is continuous over the entire circumference.
  • the annular convex part 60 is made into the taper shape from which an internal peripheral surface becomes gradually large diameter toward a protrusion front-end
  • the outer peripheral fixing portion 56 of the ring member 52 has a lower surface that extends in a direction substantially perpendicular to the axis, and includes a welding convex portion 62 that protrudes downward.
  • the welding convex portion 62 is a convex portion projecting from the radially intermediate portion of the outer periphery fixing portion 56, and has a substantially constant cross-sectional shape that becomes gradually narrower toward the projecting tip, and has a substantially uniform projecting height ( It is continuous over the entire circumference in the circumferential direction with a length from a contact surface 64 (described later) to a protruding tip surface.
  • the welding convex portion 62 is provided at a predetermined distance on the outer peripheral side with respect to the fitting convex portion 58, and the protruding height is made smaller than that of the fitting convex portion 58.
  • a contact surface 64 constituting the lower surface of the outer peripheral fixing portion 56, which is an overlapping surface with respect to the housing 12, is formed.
  • the contact surface 64 is an annular flat surface that extends with a substantially constant width over the entire circumference and extends in a direction substantially perpendicular to the axis, and is provided between the welding convex portion 62 and the fitting convex portion 58 in the radial direction. And located above the fitting convex portion 58.
  • the lower surface of the outer peripheral fixing portion 56 is located above the contact surface 64, and the outermost peripheral end portion of the outer peripheral fixing portion 56 is more than the portion where the contact surface 64 is formed. It is said to be thin.
  • the ring member 52 is fixed to the opening 20 of the housing 12, and the inner peripheral portion of the ring member 52 is the outer peripheral portion of the elastic valve element 14. Is overlaid on the outer surface. Thereby, the outer peripheral part of the elastic valve body 14 is clamped in the axial direction between the housing 12 and the ring member 52, and the medical connector 10 is formed.
  • the annular fixing portion 36 of the elastic valve body 14 is clamped in the axial direction between the valve seat 22 of the housing 12 and the inner peripheral clamping portion 54 of the ring member 52, while the housing 12
  • the locking projection 24 is inserted and locked into the inner annular groove 42 of the elastic valve body 14, and the annular projection 60 of the ring member 52 is inserted into the outer annular groove 44 of the elastic valve body 14. It is locked.
  • the medical connector 10 of this embodiment fixes the housing 12 and the ring member 52 and clamps the elastic valve body 14 between the housing 12 and the ring member 52, the housing 12 and the ring member 52 are mutually connected. It is firmly fixed in a state where it is positioned on.
  • the manufacturing process of the medical connector 10 will be described with reference to FIGS.
  • a housing 12 made of thermoplastic resin is prepared.
  • the housing 12 has a tubular shape as a whole, and a valve seat 22 that supports the outer peripheral portion of the disc-shaped elastic valve body 14 is formed on the inner peripheral side of the opening 20.
  • the housing 12 can be obtained by, for example, injection molding or molding of a thermoplastic resin. Thus, the housing preparation process is completed.
  • a ring member 52 made of thermoplastic resin is prepared.
  • the ring member 52 is attached to the opening 20 of the housing 12 so as to sandwich the outer peripheral portion of the elastic valve body 14 with the valve seat 22 of the housing 12.
  • the ring member 52 can be obtained by injection molding or molding of a thermoplastic resin, like the housing 12. The ring member preparation process is thus completed.
  • the outer peripheral portion of the elastic valve body 14 prepared in advance is supported by the valve seat 22 of the housing 12, and the opening portion 20 of the housing 12.
  • the annular fixing portion 36 of the elastic valve body 14 is inserted into the fitting concave groove 26 of the valve receiving seat 22 of the housing 12, and the locking convex portion 24 of the valve receiving seat 22 is inserted into the elastic valve body 14.
  • the elastic valve element 14 is positioned and set in the opening 20 of the housing 12 by being inserted and locked in the inner annular groove 42.
  • the valve body setting process is completed.
  • a ring member 52 is overlapped on the open end surface 32 of the housing 12 in which the elastic valve body 14 is installed. More specifically, the annular member 60 is inserted into the outer annular groove 44 of the elastic valve body 14 so that the ring member 52 is positioned in the radial direction with respect to the housing 12 while the ring member 52 is positioned in the housing. 12, the welding convex portion 62 protruding from the outer peripheral fixing portion 56 of the ring member 52 is brought into contact with the opening end surface 32 of the housing 12.
  • the fitting convex portion 58 of the ring member 52 is inserted into the opening portion 20 of the housing 12 before the welding convex portion 62 and the opening end surface 32 of the housing 12 are in contact with each other. It is positioned in the radial direction with respect to the inner peripheral surface of the opening 20.
  • the welding projection 62 abutted on the opening end surface 32 is melted in a state where the ring member 52 is superimposed on the opening end surface 32 of the housing 12. That is, as shown in FIGS. 15 and 16 (c), (c ′) and FIG. 17, the horn 70 is pressed against the ring member 52 to apply ultrasonic vibration to the welded convex portion 62 of the ring member 52. Then, frictional heat is generated at the contact portion between the tip end surface of the welding convex portion 62 and the opening end surface 32 of the housing 12 to melt the contact portion between the welding convex portion 62 and the opening end surface 32 of the housing 12.
  • the housing 12 and the ring member 52 have a diameter by melting the contact portion of the welding convex portion 62 in a state where the fitting convex portion 58 of the ring member 52 is inserted into the opening portion 20 of the housing 12. It is possible to melt the welding convex portion 62 in a state positioned in the direction. Further, by appropriately adjusting the frequency of the ultrasonic vibration transmitted from the horn 70 to the ring member 52 and setting so that only the welding convex portion 62 of the ring member 52 is melted, the welding convex portion 62 is removed. Further, the housing 12 and the ring member 52 are prevented from melting on the inner peripheral side and the shape is maintained. As described above, the melting step is performed.
  • the housing 12 and the ring member 52 move in the radial direction because the outer peripheral surface of the fitting convex portion 58 moves while sliding on the inner peripheral surface of the opening 20 in the housing 12. It is welded without displacement.
  • the guide portion for guiding the approaching displacement between the housing 12 and the ring member 52 is constituted by the fitting convex portion 58.
  • the opening end face 32 of the housing 12 and the ring member 52 are more firmly fixed by causing the resin of the welding convex portion 62 that has been heated and melted to enter the outer peripheral side outside the welding convex portion 62.
  • the housing 12 and the ring member 52 may be arranged to face each other in the axial direction with a gap on the outer peripheral side of the welding projection 62.
  • the housing 12 and the ring member 52 are opposed to each other in the axial direction with a gap on both the inner and outer circumferences outside the welding projection 62 in a state where the tip end surface of the welding projection 62 is in contact with the opening end surface 32 of the housing 12.
  • the gap functions as a space for preventing the molten resin of the welding convex portion 62 from protruding from between the opposing surfaces of the opening end surface 32 and the outer peripheral fixing portion 56.
  • the welding convex portion 62 is crushed, and the contact area between the opening end surface 32 of the housing 12 and the lower surface of the ring member 52 that are overlapped with each other increases.
  • the housing 12 and the ring member 52 are pressed in the approaching direction. That is, in this embodiment, until the welding convex part 62 is crushed and the contact surface 64 of the ring member 52 contacts the opening end surface 32 of the housing 12, the contact area between the housing 12 and the ring member 52 increases. Then, the housing 12 and the ring member 52 are pressed in the approaching direction.
  • the ring member 52 is pressed in the approaching direction against the housing 12 while the fitting convex portion 58 of the ring member 52 is inserted into the opening 20 of the housing 12, so that the ring member 52 is moved to the housing 12. Can be made to approach while positioning.
  • the housing 12 and the ring member 52 are held in a pressed state in the approaching direction, and the contact portion of the melted welding convex portion 62 is held.
  • the housing 12 and the ring member 52 are fused and integrated at the contact portion of the welding projection 62, and are integrally connected and fixed.
  • the housing 12 and the ring member 52 are continuously fixed over the entire circumference by melting the welding convex portion 62 over the entire circumference.
  • the outer peripheral part of the elastic valve body 14 set in the opening 20 of the housing 12 is sandwiched between the valve seat 22 of the housing 12 and the ring member 52, and the melting process and the valve body fixing process are completed.
  • the annular fixing portion 36 of the elastic valve body 14 is sandwiched between the valve seat 22 of the housing 12 and the fitting convex portion 58 of the ring member 52, and the locking convex portion 24 and the ring of the housing 12 are sandwiched.
  • the constricted portion 46 of the elastic valve body 14 is sandwiched between the annular convex portion 60 of the member 52.
  • the contact portion between the welding convex portion 62 of the ring member 52 and the opening end surface 32 of the housing 12 is melted by ultrasonic welding.
  • the weld portion 66 is integrated, and the weld portion 66 is continuously provided over the entire circumference.
  • the positioning portion where the opening end surface 32 of the housing 12 and the contact surface 64 of the ring member 52 that are substantially maintained in shape are in contact with each other in the axial direction. 68 is continuously provided over the entire circumference.
  • the opening end surface 32 of the housing 12 and the abutting surface 64 of the ring member 52 indirectly abut on the positioning portion 68, and the housing 12
  • the ring member 52 may be bonded at the positioning portion 68.
  • annular flat surfaces are provided at portions where the welding convex portions 62 of the ring member 52 are separated from the inner peripheral side and the outer peripheral side, respectively, and the welding convex portions 62 are formed on the inner and outer peripheral flat surfaces.
  • the opening end surface 32 of the housing 12 and the contact surface 64 of the ring member 52 are in contact with each other in the positioning portion 68, so that the housing 12
  • the ring member 52 is positioned with high accuracy in the axial direction. Therefore, excessive approach between the valve seat 22 of the housing 12 and the inner peripheral clamping portion 54 of the ring member 52 is avoided, and excessive elasticity of the elastic valve body 14 held between the housing 12 and the ring member 52 is obtained. Since deformation is prevented, the desired deformation characteristics (spring characteristics) and durability of the elastic valve body 14 can be obtained effectively.
  • the thickness dimension of the constricted portion 46 which is thinner than the annular fixing portion 36 is set stably. Therefore, the problem that the constricted portion 46 is strongly sandwiched between the locking convex portion 24 and the annular convex portion 60 and is broken or the durability is lowered is avoided, and the stability and improvement of the quality are achieved. It is done.
  • the distance between the facing surfaces of the opening end surface 32 of the housing 12 and the outer peripheral fixing portion 56 of the ring member 52 is different between the inner peripheral side and the outer peripheral side of the welding convex portion 62.
  • the facing area of the opening end surface 32 and the outer peripheral fixing portion 56 is increased on the outer peripheral side where the distance between the opposing surfaces is larger than that on the inner peripheral side.
  • the position of the housing 12 and the ring member 52 in the approaching direction is defined by the abutment of the opening end surface 32 and the outer peripheral fixing portion 56 indirectly through the molten resin that has been filled.
  • the opposing surface of the opening end surface 32 and the outer peripheral fixing portion 56 withdrawn on the outer peripheral side directly or indirectly abuts on a larger area, so that the housing
  • the relative position in the approach direction between the ring member 12 and the ring member 52 can be reliably defined, and excessive approach can be prevented.
  • the housing 12 and the ring member 52 are firmly fixed by being melted and integrally connected and fixed at the welded portion 66, so that the elastic valve body 14 is substantially inseparable. 12 and the ring member 52 are stably supported.
  • the welding part 66 is provided continuously over the entire circumference in the circumferential direction of the housing 12 and the ring member 52, and the housing 12 and the ring member 52 are fixed to each other over the entire circumference. A large welding area is secured between the housing 12 and the ring member 52 and the housing 12 and the ring member 52 are firmly fixed.
  • a positioning portion 68 is provided on the inner peripheral side of the welded portion 66 in an annular shape over the entire circumference, and the positioning action is achieved by the housing 12 and the ring member 52 continuously contacting over the entire circumference. It has come to be demonstrated. Therefore, the housing 12 and the ring member 52 can be prevented from being fixed in a relatively inclined state, and the elastic valve body 14 can be stably held between the housing 12 and the ring member 52.
  • the fitting convex portion 58 provided on the inner peripheral clamping portion 54 of the ring member 52 is inserted into the housing 12, and the outer peripheral surface of the fitting convex portion 58 substantially contacts the inner peripheral surface of the housing 12. It is piled up in the state which did. Thereby, the ring member 52 is positioned in the radial direction with respect to the housing 12, the ring member 52 is attached to an appropriate position with respect to the housing 12, and the molten resin of the welding projection 62 is on the inner peripheral side of the housing 12
  • the elastic valve body 14 is protected from heat during welding.
  • the molten resin enters between the overlapping surfaces of the fitting convex portion 58 and the inner peripheral surface of the opening portion 20 of the housing 12, stronger fixation between the housing 12 and the ring member 52 can be expected.
  • the outer peripheral wall of the opening 20 that accommodates the annular fixing portion 36 of the elastic valve body 14 in the housing 12 is made higher than the annular fixing portion 36.
  • the entire outer peripheral surface of the annular fixing portion 36 is covered with the outer peripheral wall of the opening 20 of the housing 12.
  • part with the ring member 52 in the front end surface (opening end surface) 32 of the outer peripheral wall of the opening part 20 of the housing 12 is set in the position away from the cyclic
  • the guide portion (fitting convex portion 58) provided on the ring member 52 eliminates a situation in which the molten resin directly presses the outer peripheral surface of the annular fixing portion 36 of the elastic valve body 14 and the like.
  • the holding state of the elastic valve body 14 is stably maintained, and the molten resin does not adversely affect the durability of the elastic valve body 14.
  • the fitting protrusion 58 of the ring member 52 and the entire opening 20 of the housing 12 are all. Since the fitting part over the circumference is provided, the contact of the molten resin with the elastic valve body 14 is more effectively prevented.
  • the ring convex portion 58 of the ring member 52 is inserted into the housing 12 before being inserted into the housing 12.
  • the member 52 is temporarily positioned with respect to the housing 12 in the direction perpendicular to the axis. Therefore, it is easy to fit the hard fitting convex portion 58 into the hard housing 12, and the housing 12 and the ring member 52 can be easily positioned in the direction perpendicular to the axis.
  • the locking projection 24 of the housing 12 is fitted and locked in the inner annular groove 42 and the ring member 52 is locked in the outer annular groove 44.
  • the annular projection 60 is fitted and locked.
  • the annular fixing portion 36 is pressed against the inner peripheral surface of the opening 20 in the housing 12 and the inner surface of the fitting concave groove 26 and the front end surface of the fitting convex portion 58 of the ring member 52, and the annular fixing portion.
  • the overlapping surface of 36, the housing 12, and the ring member 52 is sealed.
  • the medical connector 10 is used as, for example, a mixed injection port of a three-way stopcock 72 as shown in FIGS.
  • the three-way cock 72 has a structure in which a cock 76 is attached to a holder 74.
  • the holder 74 has a hollow structure including a main body 78 having a substantially cylindrical shape and first to third three branch pipes 80, 82, 84 protruding from the outer periphery of the main body 78. It is a molded product. These first to third branch pipes 80, 82, 84 have one end in the axial direction connected to the main body 78 and communicated with the internal space of the main body 78, and the other end is shown in FIG. As indicated by a broken line in FIG. 19, the first to third branch openings 86, 88, and 90 communicate with the external space.
  • the internal flow passages connected to the first to third branch openings 86, 88, 90 are formed by the internal spaces of the first to third branch pipes 80, 82, 84, respectively.
  • the first branch pipe 80 and the second branch pipe 82 are formed at opposing positions on the outer periphery of the main body 78 and are arranged on substantially the same axis.
  • the third branch pipe 84 is formed on the outer periphery of the main body portion 78 at a position that forms an angle of approximately 90 degrees with respect to the first branch pipe 80 and the second branch pipe 82.
  • a female luer cap 92 having an internal thread formed on the inner peripheral surface is detachably fixed to the first branch opening 86 in an externally inserted state.
  • a lock adapter 94 having an internal thread formed on the inner peripheral surface of the second branch pipe 82 is engaged with a flange-like portion (not shown) formed on the second branch pipe 82 so as not to be pulled out and is extrapolated. It is installed in a state.
  • a male luer cap 96 is detachably attached to the second branch opening 88 in an extrapolated state.
  • a cock 76 is inserted into the main body 78, and is rotatable and liquid-tightly assembled. By rotating the cock 76, the internal spaces formed by the internal spaces of the first to third branch pipes 80, 82, 84 and opened at the first to third branch openings 86, 88, 90 are provided. The flow path can be selectively communicated.
  • the three-way stopcock 72 is configured by connecting the medical connector 10 to the branch opening 90 of the third branch pipe 84 of the holder 74.
  • the first branch opening 86 is connected to the tube on the upstream side of the infusion route
  • the second branch opening 88 is connected to the tube on the downstream side.
  • the first branch pipe 80 and the second branch pipe 82 constitute a part of the infusion route and are disposed on the infusion route.
  • a luer lock connector 102 as a male connector is connected to the medical connector 10 as shown in FIG. 20A shows a state before the luer lock connector 102 is connected, and FIG. 20B shows a connection state of the luer lock connector 102.
  • the luer lock connector 102 is a conventionally known lure lock connector having a standard size defined in, for example, ISO 594.
  • the luer tip 104 has a tapered cylindrical taper shape to form an external flow path, and the outer periphery of the luer tip 104. Is provided with a female thread portion 106 surrounding the.
  • the elastic valve body 14 is elastically deformed, and as shown in FIG.
  • the luer tip 104 is inserted into the opened slit 50.
  • the internal space such as a syringe connected to the luer tip 104 is communicated with the internal channel of the third branch pipe 84 through the fluid channel in the luer tip 104.
  • the threaded portion 106 of the luer lock connector 102 is screwed into the male threaded portion 30 of the medical connector 10, so that the insertion state of the luer tip 104 is reliably maintained.
  • the cock 76 is operated to bring the third branch pipe 84 and the second branch pipe 82 into a communication state, whereby the liquid medicine filled in the syringe is mixedly injected onto the infusion route. It becomes possible. Then, after the mixed injection is completed and the luer tip 104 is removed, the central portion 34 is restored to the disk shape by the elastic restoring force of the elastic valve body 14, and the slit 50 is closed substantially airtightly. .
  • luer lock type connector having a female thread portion 106 as a male connector.
  • a so-called luer slip type connector that does not have the female thread portion 106 and includes only the luer tip 104 is also connected. Is possible.
  • the stepped shape of the housing 12 and the male screw portion 30 are not necessarily required.
  • the welding convex portion may be provided so as to protrude from the opening end surface of the housing toward the ring member.
  • the welding convex portion is partially formed in the radial direction on the overlapping surface of the housing and the ring member as in the above-described embodiment, the welding convex portion is provided in the radial intermediate portion of the overlapping surface. Although it is desirable, for example, it can be provided at the inner peripheral end or the outer peripheral end of the overlapping surface. Furthermore, a plurality of welding projections may be arranged away from each other in the radial direction.
  • a welded portion is provided at the radial intermediate portion of the overlapping surface of the housing and the ring member, as shown in the above embodiment, either the inner peripheral side or the outer peripheral side outside the welded portion is used.
  • Positioning portions may be provided only on one of them, or by providing positioning portions on both the inner peripheral side and the outer peripheral side, it is possible to obtain a higher positioning action by contact.
  • the positioning portion is preferably provided adjacent to the welding portion. Further, the welded portion and the positioning portion can be spaced apart from each other in the radial direction by providing a groove for preventing the molten resin from protruding along the welded convex portion.
  • the welding convex portion is not limited to an annular shape that is continuous over the entire circumference in the circumferential direction on the overlapping surface of the housing and the ring member.
  • a plurality of welding convex portions each having a protruding shape are provided in the circumferential direction. And may be provided intermittently apart from each other.
  • the welding convex part when the welding convex part is partially formed on the circumference on the overlapping surface of the housing and the ring member, the welding convex part may be provided continuously over the entire radial direction of the overlapping surface. good.
  • the housing and the ring member abut on each other in the axial direction between the circumferential directions of the plurality of welding projections, and the housing and the ring member are positioned relative to each other in the axial direction.
  • the fitting convex portion 58 and the annular convex portion 60 provided on the inner peripheral clamping portion 54 of the ring member 52 are not essential. That is, the shape of the lower surface of the inner peripheral clamping portion in the ring member can be changed as appropriate depending on the shape of the elastic valve body, and for example, the inner peripheral clamping portion of the ring member having a flat lower surface is also employed. obtain. Moreover, although it is desirable that the fitting convex part is continuous over the entire circumference, the fitting convex part is not necessarily provided continuously over the entire circumference as long as it is configured to be inserted into the opening of the housing. There is no need. Specifically, the fitting convex portion may have a structure divided into a plurality in the circumferential direction.
  • one opening of the cylindrical plug body 110 is liquid-tightly attached to the housing 12 of the medical connector 10 of the embodiment.
  • the medical connector 10 and the plug main body 110 constitute a mixed injection plug 108.
  • a cylindrical attachment portion 116 is provided to open upward with respect to the long infusion tube body 114, and the opening portion of the attachment portion 116 is provided.
  • the housing 12 of the medical connector 10 of the embodiment is attached in a liquid-tight manner.
  • the medical connector 10, the infusion tube 114 and the attachment portion 116 constitute a mixed injection tube 112.
  • the housing 12 of the medical connector 10 extends into a cylindrical shape, so that the medicine bag 118 is connected to the bag body 120 in which various kinds of drug solutions, physiological saline, and the like are enclosed.
  • the bag body 120 is made of a synthetic resin sheet material on which aluminum is vapor-deposited. The peripheral portion of the opening is closed by welding or the like, and is sealed integrally with the medical connector 10, whereby the medical connector 10. And the bag body 120 are connected in a liquid-tight manner.
  • the medical connector 10 and the bag body 120 constitute a drug bag 118.
  • the ring member 52 is overlapped on the opening end surface 32 of the housing 12 so that the overlapping surface of the housing 12 and the ring member 52 is welded.
  • the overlapping surface of the member 52 is not necessarily limited to the opening end surface 32 of the housing 12. That is, the outer peripheral portion of the ring member has a cylindrical shape extending toward the opening 20 of the housing 12, and the cylindrical portion is extrapolated to the opening 20 of the housing 12 and provided at the lower end of the cylindrical portion.
  • the flange portion is overlapped with the housing 12, and the welding convex portion 62 provided between the overlapping surfaces of the flange portion and the housing 12 is melted, so that the lower end of the cylindrical portion of the ring member is welded to the housing 12. You may make it.
  • the valve body setting step is a step of setting the elastic valve body 14 to the ring member 52 by inserting the annular convex portion 60 of the ring member 52 into the outer annular groove 44 of the elastic valve body 14.
  • the melting step is a step of superimposing the lower surface of the ring member 52 on which the elastic valve body 14 is set on the opening end surface 32 of the housing 12 to melt the welding convex portion 62 of the ring member 52.
  • SYMBOLS 10 Medical connector, 12: Housing, 14: Elastic valve body, 20: Opening part, 22: Valve seat, 24: Locking convex part (annular convex part), 32: Opening end surface, 42: Inner annular concave groove (Annular groove), 44: outer annular groove (annular groove), 52: ring member, 58: fitting convex part, 60: annular convex part, 62: welding convex part, 64: contact surface, 66: Welding part, 68: Positioning part

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The purpose of the present invention is to provide an improved medical connector such that an elastic valve body can be stably attached to a housing in a predetermined state, and a method of manufacturing the same. A disk-shaped elastic valve body (14) is inserted in an opening (20) which is formed in a housing (12) and provided with a valve receiving seat (22) so that the inner surface of the elastic valve body (14) is supported by the valve receiving seat (22), and a ring member (52) is placed over the outer surface of the circumferential part of the elastic valve body (14) so that the circumferential part of the elastic valve body (14) is sandwiched between the valve receiving seat (22) and the ring member (52). Further, a welded part (66) is formed by melting a welding projection (62) projecting between the housing (12) and the ring member (52) so that the housing (12) and the ring member (52) are joined and fixed together through the welded part (66), and a positioning part (68) for positioning the housing (12) and the ring member (52) relative to each other in a direction approaching each other is provided at a portion off the welding projection (62).

Description

医療用コネクタおよび医療用コネクタの製造方法Medical connector and method for manufacturing medical connector
 本発明は、輸液ルートを利用して薬液の混注や体液の採取などを行う際に、輸液ルートへの医療用接続具(雄コネクタ)の接続を可能とする医療用コネクタとその製造方法に関するものである。 TECHNICAL FIELD The present invention relates to a medical connector that enables connection of a medical connector (male connector) to an infusion route and the like, and a method of manufacturing the same, when performing mixed injection of chemical liquids or collection of body fluids using the infusion route. It is.
 従来から、輸液や採血などを行う輸液ルート上には、かかる輸液ルートを利用して薬液の混注を行ったり、体液の採取を行ったりするために、シリンジ先端のルアーチップなどの雄コネクタを接続可能とする医療用コネクタが設けられることが多い。例えば、輸液ルートの一部を構成する三方活栓では、3つの開口部のうちの一対を用いて点滴などの輸液ルートを形成し、残りの1つの開口部に対して雄コネクタの接続を可能とする医療用コネクタを設けることによって、既成の輸液ルートを利用した薬液の混注を可能としている。 Conventionally, a male connector, such as a luer tip at the tip of a syringe, has been connected to an infusion route for infusion or blood collection in order to mix medicinal fluids or collect body fluids using the infusion route. In many cases, a medical connector is provided. For example, in a three-way cock that constitutes a part of an infusion route, an infusion route such as an infusion is formed using a pair of three openings, and a male connector can be connected to the remaining one opening. By providing a medical connector, it is possible to co-inject a chemical solution using an existing infusion route.
 かかる医療用コネクタとして、例えば、特表平2-502976号公報(特許文献1)に記載の所謂スプリットセプタムタイプのものが知られている。スプリットセプタムタイプの医療用コネクタは、ディスク状の弾性弁体を開口に備えた構造とされており、雄コネクタの先端部を弾性弁体のスリットに直接挿入してスリットを押し開くことにより、輸液ルートと雄コネクタの内部連通を可能とする。 As such a medical connector, for example, a so-called split septum type connector described in JP-T-2-502976 (Patent Document 1) is known. The split septum type medical connector has a structure with a disc-shaped elastic valve body in the opening. By inserting the tip of the male connector directly into the slit of the elastic valve body and pushing the slit open, Enables internal communication between the route and male connector.
 ところで、特許文献1に記載の医療用コネクタでは、ハウジングの開口端部がスウェージング加工などで内周側に曲げられることにより、弾性弁体の外周端部が軸方向に挟持されるようになっている。 By the way, in the medical connector described in Patent Document 1, the outer end of the elastic valve body is sandwiched in the axial direction by bending the open end of the housing to the inner periphery by swaging or the like. ing.
 ところが、このような弾性弁体の支持構造では、ハウジングの開口端部を曲げ加工する際に変形量を規定し難く、それに伴って弾性弁体を一定の力で挟み込んで支持させることが難しいことから、弾性弁体のハウジングへの装着状態において、スリットの開閉特性や支持部分における弾性弁体の耐久性などに個体差が生じるおそれがあった。しかも、特許文献1に記載の構造では、ハウジングの開口端部の変形量が周上でばらつくことで、弾性弁体がハウジングに対して傾いて取り付けられてしまう場合もある。その結果、雄コネクタを弾性弁体のスリットに対して抜差しする際に、弾性弁体に対して周上で局所的に大きな応力が作用して、弾性弁体が歪に変形することでハウジングから脱落するといった不具合も生じ得る。 However, in such a support structure of the elastic valve body, it is difficult to define the deformation amount when bending the opening end of the housing, and accordingly, it is difficult to support the elastic valve body with a certain force. Therefore, when the elastic valve body is mounted on the housing, individual differences may occur in the opening / closing characteristics of the slit and the durability of the elastic valve body in the support portion. Moreover, in the structure described in Patent Document 1, the elastic valve body may be attached to the housing in an inclined manner because the deformation amount of the opening end of the housing varies on the circumference. As a result, when the male connector is inserted / removed from / to the slit of the elastic valve body, a large stress is locally applied to the elastic valve body on the circumference, and the elastic valve body is deformed into a strain so that it is deformed from the housing. There may be a problem of dropping out.
 なお、出願人は、先の出願である特開2009-11820号公報(特許文献2)において、ハウジングの開口部に挿入される別体のリング部材を用いて、リング部材とハウジングの台座との間で弾性弁体を挟んで支持する構造を提案している。特許文献2に係る医療用コネクタでは、例えば、リング部材の上面と弾性弁体の中央部分の上面とが同一平面上に位置するまでハウジング開口部の曲げ加工とリング部材の押込みとを行うことで、ハウジングに対するリング部材の相対位置を設定することが可能であるが、ハウジング開口部を溶かしてリングを覆う構成であるため、溶けのばらつきが生じやすく、弾性弁体に不均等に圧力がかかり、各部材の位置関係にばらつきが生じるおそれがあり、より高精度に位置決めする手段が求められていた。また、従来方法においては、適切な押込み量を規定することが難しく、押込み過ぎた場合は弾性弁体が過剰に沈み込んだり、加工時に弾性弁体が変形して雄ルアー挿入時の圧力分散に好適なバランスが崩れてしまうといった各部材の位置関係のばらつきが生じ、押込みが不足した場合は十分固着強度を実現できないおそれがあるため、溶融工程時に非常に高度な制御・調整が必要となる。 In addition, in the prior application Japanese Patent Application Laid-Open No. 2009-11820 (Patent Document 2), the applicant uses a separate ring member to be inserted into the opening of the housing, so that the ring member and the pedestal of the housing A structure is proposed in which an elastic valve body is sandwiched between and supported. In the medical connector according to Patent Document 2, for example, the housing opening is bent and the ring member is pushed in until the upper surface of the ring member and the upper surface of the central portion of the elastic valve body are located on the same plane. It is possible to set the relative position of the ring member with respect to the housing. There is a possibility that the positional relationship of each member may vary, and a means for positioning with higher accuracy has been demanded. Also, in the conventional method, it is difficult to define an appropriate push amount. If the positional relationship of each member is varied such that a suitable balance is lost, and if the pressing is insufficient, there is a possibility that a sufficient fixing strength cannot be realized.
特表平2-502976号公報JP-T-2-502976 特開2009-11820号公報JP 2009-11820 A
 本発明は、上述の事情を背景に為されたものであって、その解決課題は、弾性弁体をハウジングに対してばらつきの少ない略一定の状態に取り付けることが可能とされた、改良された医療用コネクタとその製造方法を提供することにある。 The present invention has been made in the background of the above-described circumstances, and the problem to be solved is an improvement in which the elastic valve body can be attached to the housing in a substantially constant state with little variation. It is to provide a medical connector and a manufacturing method thereof.
 以下、このような課題を解決するために為された本発明の態様を記載する。なお、以下に記載の各態様において採用される構成要素は、可能な限り任意の組み合わせで採用可能である。 Hereinafter, embodiments of the present invention made to solve such problems will be described. In addition, the component employ | adopted in each aspect as described below is employable by arbitrary combinations as much as possible.
 すなわち、本発明の第1の態様は、医療用コネクタの製造方法であって、ディスク状の弾性弁体の外周部分を支持する弁受座が形成された開口部を備えた熱可塑性樹脂製のハウジングを準備するハウジング準備工程と、該ハウジングの前記開口部に取り付けられて前記弾性弁体の外周部分を前記弁受座との間で挟持する熱可塑性樹脂製のリング部材を準備するリング部材準備工程と、前記弾性弁体を前記ハウジングの前記弁受座で支持させて前記開口部にセットする弁体セット工程と、前記弾性弁体がセットされた前記ハウジングに前記リング部材を重ね合わせて、それらハウジングとリング部材の重ね合わせ面に突設した溶着凸部を溶融させる溶融工程と、該溶融工程における前記溶着凸部の溶融状態下で、該溶着凸部が潰れて前記ハウジングと前記リング部材の重ね合わせ面の当接面積が増大するまで該ハウジングと該リング部材を接近方向へ押圧してそれらハウジングとリング部材を該溶着凸部で一体的に連結固着することにより、該ハウンジングの前記弁受座と該リング部材で前記弾性弁体の外周部分を挟持させる弁体固定工程とを、有することを特徴とする。 That is, the first aspect of the present invention is a method of manufacturing a medical connector, which is made of a thermoplastic resin having an opening in which a valve seat for supporting an outer peripheral portion of a disk-like elastic valve body is formed. A housing preparation step for preparing a housing, and a ring member preparation for preparing a ring member made of a thermoplastic resin that is attached to the opening of the housing and sandwiches an outer peripheral portion of the elastic valve body with the valve seat. A step of supporting the elastic valve body by the valve seat of the housing and setting the opening in the opening, and overlapping the ring member on the housing in which the elastic valve body is set, In the melting step of melting the welding projection protruding from the overlapping surface of the housing and the ring member, and in the melting state of the welding projection in the melting step, the welding projection is crushed and the how By pressing the housing and the ring member in the approaching direction until the contact area of the overlapping surface of the ring and the ring member increases, the housing and the ring member are integrally connected and fixed by the welding convex portion, And a valve body fixing step of clamping the outer peripheral portion of the elastic valve body with the ring member and the valve seat of the housing.
 このような第1の態様に従う医療用コネクタの製造方法によれば、ハウジングとリング部材との間に設けられた溶着凸部を溶かして、ハウジングとリング部材とを固着する構成であるため、従来方法に比べ、溶けのばらつきが生じにくく、弾性弁体に不均等に圧力がかかる事態が生じにくい。さらに、溶着凸部は溶けやすいために押し込みやすいが、溶着凸部が完全に溶けると、ハウジングとリング部材の面と面とが突き当たり、押し込みにくくなるため、押込み過ぎを防ぐことが出来る。このため、高度な制御・調整を要せず、従来に比べて格段にばらつきが生じにくい。 According to the manufacturing method of the medical connector according to the first aspect as described above, since the welding convex portion provided between the housing and the ring member is melted and the housing and the ring member are fixed, Compared to the method, melting variations are less likely to occur, and a situation in which pressure is applied unevenly to the elastic valve body is less likely to occur. Furthermore, since the welding convex portion is easy to melt, it is easy to push in. However, when the welding convex portion is completely melted, the surfaces of the housing and the ring member come into contact with each other, making it difficult to push in. For this reason, advanced control / adjustment is not required, and variations are much less likely to occur than in the past.
 また、ハウジングとリング部材を溶着凸部の溶融によって一体的に連結固着することにより、ハウジングとリング部材の重ね合わせ面に溶着凸部を突設する簡単な構造で、ハウジングとリング部材を強固に固定して、弾性弁体を安定して支持することができる。 In addition, the housing and the ring member are integrally connected and fixed together by melting the welding convex portion, so that the welding convex portion protrudes on the overlapping surface of the housing and the ring member, and the housing and the ring member are strengthened. The elastic valve body can be stably supported by fixing.
 本発明の第2の態様は、第1の態様に記載された医療用コネクタの製造方法において、前記ハウジングと前記リング部材の重ね合わせ面において、重ね合わせ面から先端部までの長さが均一に形成された前記溶着凸部を全周に亘って連続的にして或いは周方向に断続的に設けたものである。 According to a second aspect of the present invention, in the method for manufacturing a medical connector described in the first aspect, the length from the overlapping surface to the tip end portion is uniform in the overlapping surface of the housing and the ring member. The formed welding convex portion is provided continuously over the entire circumference or intermittently in the circumferential direction.
 第2の態様によれば、溶着凸部の当接部を周方向環状に設けて、ハウジングとリング部材を全周に亘って一体的に連結固着することで、ハウジングとリング部材のより強固な固着を実現することができる。更に、ハウジングとリング部材を全周に亘って連続して固着することで、固着部分の周方向端部に応力が集中するのを回避して、リング部材がハウジングから剥がれ落ちるといった不具合をより確実に防ぐことができる。また、弾性弁体に対し不均等に圧力が加わることを防止できるため、固着後における弾性弁体の位置ズレが生じにくく、リング部材がハウジングから剥がれ落ちるといった不具合をより確実に防ぐことができる。 According to the second aspect, the contact portion of the welding convex portion is provided in an annular shape in the circumferential direction, and the housing and the ring member are integrally connected and fixed over the entire circumference, thereby further strengthening the housing and the ring member. Adherence can be realized. Furthermore, by fixing the housing and the ring member continuously over the entire circumference, stress can be prevented from concentrating on the circumferential end of the fixed portion, and the problem that the ring member is peeled off from the housing more reliably. Can be prevented. Further, since it is possible to prevent pressure from being applied unevenly to the elastic valve body, it is difficult to cause positional displacement of the elastic valve body after fixing, and it is possible to more reliably prevent a problem that the ring member is peeled off from the housing.
 本発明の第3の態様は、第1又は第2の態様に記載された医療用コネクタの製造方法において、前記弾性弁体として、外周部分の内外両面にそれぞれ開口して周方向に延びる環状凹溝が設けられた構造を採用する一方、前記ハウジングとして、該弾性弁体の内面に設けられた該環状凹溝に差し入れられる環状凸部が設けられた前記弁受座の構造を採用すると共に、前記リング部材として、該弾性弁体の外面に設けられた該環状凹溝に差し入れられる環状凸部が設けられた構造を採用し、前記弁体セット工程において、該弾性弁体の内面の該環状凹溝に対して該ハウジングの該弁受座の該環状凸部を差し入れてセットして、前記溶融工程および前記弁体固定工程において、該弾性弁体の外面の該環状凹溝に対して該リング部材の該環状凸部を差し入れることにより、該弾性弁体の内外面の各該環状凹溝に対して各該環状凸部を押し入れて嵌め合わせるものである。 According to a third aspect of the present invention, in the method for manufacturing a medical connector described in the first or second aspect, as the elastic valve body, an annular recess that opens in the inner and outer surfaces of the outer peripheral portion and extends in the circumferential direction is provided. While adopting a structure provided with a groove, while adopting the structure of the valve seat provided with an annular convex portion inserted into the annular concave groove provided on the inner surface of the elastic valve body as the housing, As the ring member, a structure in which an annular convex portion to be inserted into the annular concave groove provided on the outer surface of the elastic valve body is adopted, and in the valve body setting step, the annular shape of the inner surface of the elastic valve body is adopted. The annular convex portion of the valve seat of the housing is inserted into the concave groove and set, and in the melting step and the valve body fixing step, the annular concave groove on the outer surface of the elastic valve body is The annular convex part of the ring member By then put are those fitted by pushing the respective annular protrusions for each annular groove of the inner and outer surfaces of the elastic valve body.
 第3の態様によれば、弁体セット工程においてハウジングの環状凸部を弾性弁体の内面の環状凹溝に差し入れることで、弾性弁体をハウジングの開口部にある程度位置決めされた状態でセットすることができて、溶融工程および弁体固定工程における製造作業をし易くできる。更に、リング部材の環状凸部を弾性弁体の外面の環状凹溝に差し入れて、リング部材を弾性弁体およびハウジングに対してある程度位置決めした状態でセットすることにより、溶融工程と弁体固定工程において、ハウジングとリング部材を接近方向へ押圧する際に、ハウジングとリング部材の相対的な位置ずれが生じ難い。更にまた、ハウジングとリング部材を固着して、内外面の各環状凹溝に対して各環状凸部を押し入れて嵌め合わせることで、環状凹溝の内面に環状凸部を係止させて弾性弁体をハウジングおよびリング部材に対して位置決めすることができる。これらによって、ハウジングとリング部材と弾性弁体とを、接近方向だけでなく、それに直交する方向でも相互に位置決めして、精度良く固定することができる。 According to the third aspect, the elastic valve body is set in a state where it is positioned to some extent in the opening of the housing by inserting the annular convex portion of the housing into the annular concave groove on the inner surface of the elastic valve body in the valve body setting step. It is possible to facilitate the manufacturing work in the melting step and the valve body fixing step. Further, by inserting the annular convex portion of the ring member into the annular concave groove on the outer surface of the elastic valve body and setting the ring member in a state where it is positioned to some extent with respect to the elastic valve body and the housing, the melting step and the valve body fixing step In this case, when the housing and the ring member are pressed in the approaching direction, relative displacement between the housing and the ring member is unlikely to occur. Furthermore, by fixing the housing and the ring member and inserting and fitting the respective annular convex portions into the respective annular concave grooves on the inner and outer surfaces, the annular convex portion is locked to the inner surface of the annular concave groove and the elastic valve. The body can be positioned relative to the housing and the ring member. Accordingly, the housing, the ring member, and the elastic valve body can be positioned with respect to each other not only in the approaching direction but also in the direction orthogonal thereto, and can be fixed with high accuracy.
 本発明の第4の態様は、第1~第3の何れか1つの態様に記載された医療用コネクタの製造方法であって、前記溶融工程において、前記ハウジングと前記リング部材の重ね合わせ面における前記溶着凸部の当接部に対して超音波振動をおよぼして溶融させるものである。 According to a fourth aspect of the present invention, there is provided the method for manufacturing a medical connector according to any one of the first to third aspects, wherein the housing and the ring member are overlapped in the melting step. The contact portion of the welding convex portion is melted by applying ultrasonic vibration.
 第4の態様によれば、周波数や出力を調節することで、溶着凸部の当接部のみを選択的に溶融させることが比較的に容易であり、溶着凸部を外れた部分でハウジングとリング部材を当接によって位置決めしながら、溶着凸部の当接部においてハウジングとリング部材を固着することができる。 According to the fourth aspect, it is relatively easy to selectively melt only the contact portion of the welding convex portion by adjusting the frequency and the output, and the housing and the portion at the portion where the welding convex portion is removed. While the ring member is positioned by contact, the housing and the ring member can be fixed at the contact portion of the welding convex portion.
 本発明の第5の態様は、第1~第4の何れか1つの態様に記載された医療用コネクタの製造方法であって、前記リング部材として、前記ハウジングの前記開口部に挿し入れられて該ハウジングの該開口部の内周面に対して径方向に位置決めされる嵌合凸部を設けた構造を採用し、前記溶融工程および前記弁体固定工程において、該リング部材の該嵌合凸部を該ハウジングの該開口部に挿し入れた状態で前記溶着凸部を溶融させるものである。 A fifth aspect of the present invention is the method for manufacturing a medical connector according to any one of the first to fourth aspects, wherein the ring member is inserted into the opening of the housing. A structure provided with a fitting convex portion that is positioned in the radial direction with respect to the inner peripheral surface of the opening of the housing is adopted, and the fitting convexity of the ring member is used in the melting step and the valve body fixing step. The welding convex portion is melted in a state where the portion is inserted into the opening of the housing.
 第5の態様によれば、リング部材の嵌合凸部をハウジングの開口部に挿し入れることで、リング部材をハウジングの開口部に対して位置決めしながら、ハウジングとリング部材を溶着することができる。それ故、ハウジングとリング部材の相対的な位置のずれを、接近方向だけでなく径方向でも防いで、それらハウジングとリング部材を目的とする相対的な位置関係で高精度に連結固着することができる。 According to the 5th aspect, a housing and a ring member can be welded, positioning a ring member with respect to the opening part of a housing by inserting the fitting convex part of a ring member in the opening part of a housing. . Therefore, it is possible to prevent the relative displacement between the housing and the ring member not only in the approaching direction but also in the radial direction, and to connect and fix the housing and the ring member with high accuracy in the relative positional relationship of interest. it can.
 また、嵌合凸部の外周面を筒状として、全周に亘ってハウジングの開口部の内周面に重ね合わせるようにすれば、溶着凸部の溶融時に溶融樹脂(ウェルド)がハウジングの内周側に入り込むのを防ぐことができて、加熱された樹脂への接触による弾性弁体の劣化などが防止される。しかも、嵌合凸部とハウジングの重ね合わせ面間の微小隙間に溶融樹脂が充填されることで、ハウジングとリング部材の固着強度の向上も期待できる。 Further, if the outer peripheral surface of the fitting convex portion is formed into a cylindrical shape and overlapped with the inner peripheral surface of the opening portion of the housing over the entire circumference, the molten resin (weld) is melted inside the housing when the welding convex portion is melted. Intrusion into the circumferential side can be prevented, and deterioration of the elastic valve body due to contact with the heated resin is prevented. In addition, since the molten resin is filled in the minute gaps between the mating projections and the overlapping surfaces of the housing, an improvement in the fixing strength between the housing and the ring member can be expected.
 本発明の第6の態様は、ハウジングの開口部に対してディスク状の弾性弁体が組み付けられて、該弾性弁体の外周部分が該ハウジングで支持されている医療用コネクタであって、前記ハウジングの前記開口部において前記弾性弁体の外周部分の内面を支持する弁受座が形成されていると共に、該弾性弁体の外周部分の外面にリング部材が重ね合わされて、該弾性弁体の周囲において該ハウジングと該リング部材とが直接に固着されることにより該弁受座と該リング部材との間で該弾性弁体の外周部分が挟持されており、該ハウジングと該リング部材との固着部分では、それらハウジングとリング部材の重ね合わせ面間に突設された溶着凸部が溶融されて溶着部が設けられていると共に、該重ね合わせ面間における該溶着凸部を外れた部分が相互に当接して該ハウジングと該リング部材を接近方向で位置決めする位置決め部が設けられていることを、特徴とする。 A sixth aspect of the present invention is a medical connector in which a disc-shaped elastic valve body is assembled to an opening of a housing, and an outer peripheral portion of the elastic valve body is supported by the housing, A valve seat for supporting the inner surface of the outer peripheral portion of the elastic valve body is formed in the opening of the housing, and a ring member is superimposed on the outer surface of the outer peripheral portion of the elastic valve body, The outer peripheral portion of the elastic valve body is sandwiched between the valve seat and the ring member by directly adhering the housing and the ring member around, and the housing and the ring member In the fixing portion, the welding convex portion protruding between the overlapping surfaces of the housing and the ring member is melted to provide a welding portion, and the portion that is out of the welding convex portion between the overlapping surfaces is provided. That positioning portion for positioning said housing and said ring member in the approaching direction are provided mutually in contact, characterized.
 本発明の第6の態様に従う構造とされた医療用コネクタによれば、ハウジングとリング部材の重ね合わせ面が、溶着凸部が溶融された部分である溶着部において一体的に連結固着されていると共に、溶着凸部を外れた部分である位置決め部において相互に当接せしめられている。これにより、ハウジングとリング部材の強固な固定を実現しながら、ハウジングとリング部材の接近方向の相対的な位置を高精度に設定することができる。従って、弾性弁体の外周部分がハウジングとリング部材の間で過剰に強く挟み込まれて、目的とする弾性弁体の耐久性や変形特性(ばね定数)を安定して有効に得ることができる。このため、弾性弁体の耐久性の低下や連通と遮断の切替え特性への悪影響などを生じたり、反対に充分な力で挟持されず、弾性弁体がハウジングから脱落するなどといった不具合を、何れも回避することができる。 According to the medical connector having the structure according to the sixth aspect of the present invention, the overlapping surface of the housing and the ring member is integrally connected and fixed at the welded portion where the welded convex portion is melted. At the same time, they are brought into contact with each other at the positioning portion which is a portion where the welding convex portion is removed. Thereby, the relative position of the approaching direction of the housing and the ring member can be set with high accuracy while realizing the firm fixation of the housing and the ring member. Accordingly, the outer peripheral portion of the elastic valve body is sandwiched excessively between the housing and the ring member, and the durability and deformation characteristics (spring constant) of the target elastic valve body can be stably and effectively obtained. For this reason, problems such as a decrease in the durability of the elastic valve body and an adverse effect on the switching characteristics between communication and blocking, and conversely, the elastic valve body will not be clamped with sufficient force and the elastic valve body will drop from the housing. Can also be avoided.
 なお、位置決め部における重ね合わせ面の相互の当接は、直接でも良いし、溶着凸部を介して間接でも良い。即ち、溶着凸部が略残らずに完全に溶けることにより、溶着凸部を含む周辺部分で、ハウジングとリング部材が溶着凸部より大きな面と面をもって相互に突き当たって位置決めされるものであれば良い。 In addition, mutual contact | abutting of the overlapping surface in a positioning part may be direct, and may be indirect via a welding convex part. That is, if the welding convex part is completely melted without substantially remaining, and the peripheral part including the welding convex part is positioned so that the housing and the ring member abut each other with a surface larger than the welding convex part. good.
 本発明の第7の態様は、第6の態様に記載された医療用コネクタにおいて、前記リング部材には、前記ハウジングと係合し、該ハウジングと前記リング部材とが重ね合わされてから溶着凸部が溶融し、重ね合わせ面間における該溶着凸部を外れた部分が相互に当接するまでの前記ハウジングの移動をガイドするガイド部が形成されているものである。 According to a seventh aspect of the present invention, in the medical connector according to the sixth aspect, the ring member is engaged with the housing, and the welding convex portion is formed after the housing and the ring member are overlapped with each other. The guide part which guides the movement of the said housing until the part which remove | deviated this welding convex part between the overlapping surfaces and contact | abutted mutually is formed.
 第7の態様によれば、ハウジングとリング部材の溶着時に、ガイド部によってガイドしながらハウジングとリング部材を接近変位させることにより、ハウジングとリング部のずれが防止されて、適切な位置で相互に固着される。 According to the seventh aspect, when the housing and the ring member are welded, the housing and the ring member are moved closer to each other while being guided by the guide portion, thereby preventing the housing and the ring portion from being displaced from each other at an appropriate position. It is fixed.
 本発明の第8の態様は、第6又は第7の態様に記載された医療用コネクタにおいて、前記溶着部が前記ハウジングの周方向で全周に亘って連続して形成されていると共に、該溶着部を径方向に外れた位置に前記位置決め部が設けられているものである。 According to an eighth aspect of the present invention, in the medical connector described in the sixth or seventh aspect, the welded portion is continuously formed over the entire circumference in the circumferential direction of the housing. The positioning portion is provided at a position where the welded portion deviates in the radial direction.
 第8の態様によれば、溶着部が全周に亘って連続して形成されていることから、ハウジングとリング部材を強固に且つ周上で安定して固着することができて、ハウジングとリング部材の間に弾性弁体が安定して挟持される。更に、溶着部を径方向に外れた位置に位置決め部を設けることで、位置決め部を全周に亘って連続して設けることができて、ハウジングとリング部材が相対的に傾いた状態で固定されるのを防いで、弾性弁体をより安定して挟持させることができる。 According to the eighth aspect, since the welded portion is continuously formed over the entire circumference, the housing and the ring member can be firmly and stably fixed on the circumference. The elastic valve body is stably sandwiched between the members. Furthermore, by providing the positioning portion at a position where the welded portion is deviated in the radial direction, the positioning portion can be continuously provided over the entire circumference, and the housing and the ring member are fixed in a relatively inclined state. And the elastic valve body can be held more stably.
 本発明の第9の態様は、第6~第8の何れか1つの態様に記載された医療用コネクタであって、前記リング部材において、前記ハウジングの前記開口部に挿し入れられて該ハウジングの該開口部の内周面に対して径方向に位置決めされる嵌合凸部が設けられているものである。 According to a ninth aspect of the present invention, there is provided the medical connector according to any one of the sixth to eighth aspects, wherein the ring member is inserted into the opening of the housing. A fitting convex portion that is positioned in the radial direction with respect to the inner peripheral surface of the opening is provided.
 第9の態様によれば、ハウジングの開口部に嵌合凸部が挿し入れられることで、ハウジングとリング部材が径方向で位置決めされることから、ハウジングとリング部材の径方向での位置ずれを防ぐことができる。また、嵌合凸部の外周面がハウジングの開口部の内周面に対応する形状とされて、嵌合凸部の外周面がハウジングの開口部の内周面に全周で重ね合わされるようにすれば、溶着凸部の溶融樹脂がハウジングの内周側に入り込むのが嵌合凸部によって堰き止められて防止される。しかも、嵌合凸部とハウジングの開口部との重ね合わせ面間に溶融樹脂が入り込むことによって、ハウジングとリング部材の固着強度の向上も図られ得る。 According to the ninth aspect, since the housing and the ring member are positioned in the radial direction by inserting the fitting convex portion into the opening of the housing, the positional deviation in the radial direction of the housing and the ring member is prevented. Can be prevented. In addition, the outer peripheral surface of the fitting convex portion has a shape corresponding to the inner peripheral surface of the opening portion of the housing, and the outer peripheral surface of the fitting convex portion is overlapped with the inner peripheral surface of the opening portion of the housing over the entire circumference. In this case, the molten resin of the welding convex portion is prevented from entering the inner peripheral side of the housing by being blocked by the fitting convex portion. In addition, since the molten resin enters between the overlapping surfaces of the fitting convex portion and the opening of the housing, the fixing strength between the housing and the ring member can be improved.
 本発明の第10の態様は、ディスク状の弾性弁体の外周部分を支持する弁受座が形成された開口部を備えた熱可塑性樹脂製のハウジングを準備するハウジング準備工程と、該ハウジングの前記開口部に取り付けられて前記弾性弁体の外周部分を前記弁受座との間で挟持する熱可塑性樹脂製のリング部材を準備するリング部材準備工程と、前記弾性弁体を前記リング部材にセットする弁体セット工程と、前記弾性弁体がセットされた前記リング部材に前記ハウジングを重ね合わせて、それらハウジングとリング部材の重ね合わせ面に突設した溶着凸部を溶融させる溶融工程と、該溶融工程における前記溶着凸部の溶融状態下で、該溶着凸部が潰れて前記ハウジングと前記リング部材の重ね合わせ面の当接面積が増大するまで該ハウジングと該リング部材を接近方向へ押圧してそれらハウジングとリング部材を該溶着凸部で一体的に連結固着することにより、該ハウンジングの前記弁受座と該リング部材で前記弾性弁体の外周部分を挟持させる弁体固定工程とを、有することを、特徴とする。 According to a tenth aspect of the present invention, there is provided a housing preparing step of preparing a thermoplastic resin housing having an opening in which a valve seat for supporting an outer peripheral portion of a disc-shaped elastic valve body is formed; A ring member preparing step of preparing a ring member made of a thermoplastic resin that is attached to the opening and sandwiches an outer peripheral portion of the elastic valve body with the valve seat; and the elastic valve body as the ring member A valve body setting step for setting, a melting step for superimposing the housing on the ring member on which the elastic valve body is set, and melting a welding convex portion protruding from the overlapping surface of the housing and the ring member; Under the molten state of the welding protrusion in the melting step, the welding protrusion is crushed and the housing and the ring member are in contact with each other until the contact area between the overlapping surfaces of the housing and the ring member increases. The housing member and the ring member are integrally connected and fixed by the welding convex portion by pressing the housing member in the approaching direction, thereby holding the outer peripheral portion of the elastic valve body by the valve seat of the housing and the ring member. And a valve body fixing step.
 第10の態様に従う医療用コネクタの製造方法によれば、第1の態様と同様に、溶着凸部が略均一に溶融することで、ハウジングとリング部材との間に挟持される弾性弁体に不均等な圧力がかかり難いと共に、重ね合わせ面の当接面積の増大によってハウジングとリング部材が接近方向で位置決めされることで、押し込み過ぎを防ぐことができる。更に、弾性弁体がセットされたリング部材をハウジングに固着することで、弾性弁体がハウジングに差し入れられることから、弁体のハウジングへの取付けがより容易になる。 According to the method for manufacturing a medical connector according to the tenth aspect, as in the first aspect, the welded convex portion melts substantially uniformly, so that the elastic valve body sandwiched between the housing and the ring member Uneven pressure is unlikely to be applied, and the housing and the ring member are positioned in the approaching direction by increasing the contact area of the overlapping surface, thereby preventing excessive pressing. Further, by fixing the ring member on which the elastic valve body is set to the housing, the elastic valve body is inserted into the housing, so that the attachment of the valve body to the housing becomes easier.
 また、弾性弁体の外周部分がハウジングとリング部材の間で挟持される際に、弾性弁体の外周端部が内周側に膨出変形するのを環状凸部が制限することから、環状凹部よりも外周部分において、弾性弁体とハウジングおよびリング部材との間が特別なシール部材を要することなく封止される。 Further, when the outer peripheral portion of the elastic valve body is sandwiched between the housing and the ring member, the annular convex portion restricts the outer peripheral end portion of the elastic valve body from bulging and deforming toward the inner peripheral side. The area between the elastic valve body, the housing, and the ring member is sealed at the outer peripheral portion rather than the recess without requiring a special seal member.
 本発明によれば、弾性弁体をハウジングに対してばらつきの少ない略一定の状態に取り付けることが可能とされた、改良された医療用コネクタを製造することができる。 According to the present invention, it is possible to manufacture an improved medical connector in which the elastic valve body can be attached to the housing in a substantially constant state with little variation.
本発明の一実施形態としての医療用コネクタの斜視図。The perspective view of the medical connector as one Embodiment of this invention. 図1に示す医療用コネクタの正面図。The front view of the medical connector shown in FIG. 図1に示す医療用コネクタの縦断面図。The longitudinal cross-sectional view of the medical connector shown in FIG. 図1に示す医療用コネクタを構成するハウジングの斜視図。The perspective view of the housing which comprises the medical connector shown in FIG. 図4に示すハウジングの正面図。The front view of the housing shown in FIG. 図4に示すハウジングの縦断面図。The longitudinal cross-sectional view of the housing shown in FIG. 図1に示す医療用コネクタを構成する弾性弁体の斜視図。The perspective view of the elastic valve body which comprises the medical connector shown in FIG. 図7に示す弾性弁体の正面図。The front view of the elastic valve body shown in FIG. 図7に示す弾性弁体の縦断面図。The longitudinal cross-sectional view of the elastic valve body shown in FIG. 図1に示す医療用コネクタを構成するリング部材の斜視図。The perspective view of the ring member which comprises the medical connector shown in FIG. 図10に示すリング部材の正面図。The front view of the ring member shown in FIG. 図10に示すリング部材の縦断面図。The longitudinal cross-sectional view of the ring member shown in FIG. 図1に示す医療用コネクタの製造工程を説明する斜視図。The perspective view explaining the manufacturing process of the medical connector shown in FIG. 図13に示す医療用コネクタの製造工程を説明する断面斜視図。FIG. 14 is a cross-sectional perspective view illustrating a manufacturing process of the medical connector shown in FIG. 13. 図1に示す医療用コネクタの製造工程を説明する正面図。The front view explaining the manufacturing process of the medical connector shown in FIG. 図15に示す医療用コネクタの製造工程を説明する縦断面図。The longitudinal cross-sectional view explaining the manufacturing process of the medical connector shown in FIG. 図16に示す医療用コネクタの製造工程における要部を拡大して示す縦断面図。The longitudinal cross-sectional view which expands and shows the principal part in the manufacturing process of the medical connector shown in FIG. 図1に示す医療用コネクタを備える三方活栓の斜視図。The perspective view of a three-way cock provided with the medical connector shown in FIG. 図18に示す三方活栓の正面図。The front view of the three-way cock shown in FIG. 図1に示す医療用コネクタに対するルアーロックコネクタの接続方法を説明するための断面モデル図。Sectional model figure for demonstrating the connection method of the luer lock connector with respect to the medical connector shown in FIG. 本発明に係る医療用コネクタの別の使用例を示す斜視図であって、(a)が混注プラグを、(b)が混注管を、(c)が輸液バッグを、それぞれ示す。It is a perspective view which shows another example of use of the medical connector which concerns on this invention, Comprising: (a) shows a mixed injection plug, (b) shows a mixed injection pipe, (c) shows an infusion bag, respectively.
 以下、本発明の実施形態について、図面を参照しつつ説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
 図1~3に、本発明の一実施形態としての医療用コネクタ10を示す。医療用コネクタ10は、筒形状を呈するハウジング12の中心孔に、ディスク形状を呈する弾性弁体14が組み付けられて、弾性弁体14の外周部分がハウジング12によって支持された構造を有している。なお、以下の説明において上下方向とは、特に断りのない限り、図2中の上下方向を言うものとする。また、図1~20は、同一の実施形態を示すが、見易さのために適宜に拡大または縮小されている。 1 to 3 show a medical connector 10 as an embodiment of the present invention. The medical connector 10 has a structure in which an elastic valve body 14 having a disk shape is assembled in a central hole of a housing 12 having a cylindrical shape, and an outer peripheral portion of the elastic valve body 14 is supported by the housing 12. . In the following description, the vertical direction means the vertical direction in FIG. 2 unless otherwise specified. 1 to 20 show the same embodiment, but are appropriately enlarged or reduced for ease of viewing.
 より詳細には、ハウジング12は、図4~6に示すように、大径筒部16と小径筒部18が一体形成された段付円筒形状を有している。小径筒部18の内径寸法は少なくとも開口部20(図6中、上側の開口部)において弾性弁体14を収容し得る大きさとされ、雄コネクタ抜去後のスリット50(後述)の再封止状態が安定して発現されるように、好適には、弾性弁体14の外径寸法と略等しくされる。 More specifically, the housing 12 has a stepped cylindrical shape in which a large diameter cylindrical portion 16 and a small diameter cylindrical portion 18 are integrally formed as shown in FIGS. The inner diameter dimension of the small-diameter cylindrical portion 18 is such that at least the opening 20 (the upper opening in FIG. 6) can accommodate the elastic valve element 14, and the slit 50 (described later) after the male connector is removed is resealed. Is preferably made substantially equal to the outer diameter dimension of the elastic valve body 14 so that is stably expressed.
 かかるハウジング12は、弾性弁体14を確実に保持し得る強度を有する材料から形成されることが好ましく、具体的には、ポリプロピレン、ポリエチレン、ポリ塩化ビニル、ポリカーボネート、ポリスチレン、ポリアセタール等の熱可塑性樹脂が例示される。そして、ハウジング12は、これらの材料から射出成形等によって成形される。 The housing 12 is preferably formed of a material having a strength capable of reliably holding the elastic valve body 14, and specifically, a thermoplastic resin such as polypropylene, polyethylene, polyvinyl chloride, polycarbonate, polystyrene, polyacetal, or the like. Is exemplified. The housing 12 is molded from these materials by injection molding or the like.
 また、小径筒部18には、径方向内方に突出する環状の弁受座22が一体形成されており、弁受座22の内周縁部には、小径筒部18の開口方向外方(図6中、上方)に向けて突出する環状凸部としての係止凸部24が一体形成されている。係止凸部24は、一定の突出高さ寸法をもって全周に亘って連続する周壁形状とされており、弁受座22と係止凸部24によって環状の嵌合凹溝26が形成されて、ハウジング12の開口部20に向かって開口している。更に、係止凸部24の内周面から弁受座22の内周面に至る部分は、湾曲凸形の一定断面形状で周方向の全周に亘って延びる当接内周面28とされている。 In addition, an annular valve seat 22 that protrudes radially inward is integrally formed on the small diameter cylindrical portion 18, and the inner peripheral edge of the valve seat 22 is formed outwardly in the opening direction of the small diameter cylindrical portion 18 ( In FIG. 6, a locking convex portion 24 is integrally formed as an annular convex portion projecting upward. The locking projection 24 has a peripheral wall shape that is continuous over the entire circumference with a constant protrusion height dimension, and an annular fitting groove 26 is formed by the valve seat 22 and the locking projection 24. , Opening toward the opening 20 of the housing 12. Further, a portion extending from the inner peripheral surface of the locking convex portion 24 to the inner peripheral surface of the valve seat 22 is a contact inner peripheral surface 28 that extends over the entire circumference in the circumferential direction with a curved convex shape. ing.
 また、小径筒部18の外周面には、後述するルアーロックコネクタ102の雌ねじ部106が螺合する雄ねじ部30が形成されている。雄ねじ部30は、好適にはISO594で規定された、ねじの山頂径が7.0±0.2mm、ねじの谷底径が8.0±0.1mmに設定されたルアーロックコネクタ102の雌ねじ部106との接続が可能な二条ねじとされる。 Further, on the outer peripheral surface of the small diameter cylindrical portion 18, a male screw portion 30 into which a female screw portion 106 of the luer lock connector 102 described later is screwed is formed. The male threaded portion 30 is preferably a female threaded portion of the luer lock connector 102 stipulated by ISO 594, in which the peak diameter of the screw is set to 7.0 ± 0.2 mm and the root diameter of the screw is set to 8.0 ± 0.1 mm. This is a double thread that can be connected to 106.
 なお、ハウジング12の外径寸法は、ISO594で規定された標準的なルアーチップ104の接続を可能とするために、本実施形態のような雄ねじ部30を形成しない場合には、小径筒部18の外径が6.0~7.0mmの範囲内で設定されることが好ましく、本実施形態のように雄ねじ部30を形成する場合には、ねじ山を含んだ小径筒部18の外径が7.0~8.0mmの範囲内で設定されることが好ましい。 Note that the outer diameter of the housing 12 is such that the standard luer tip 104 defined in ISO 594 can be connected. Is preferably set within a range of 6.0 to 7.0 mm. When the male screw portion 30 is formed as in the present embodiment, the outer diameter of the small-diameter cylindrical portion 18 including a thread is provided. Is preferably set within a range of 7.0 to 8.0 mm.
 また、ハウジング12の小径筒部18側の軸方向端面である開口端面32は、略一定の幅寸法で周方向全周に連続する環状の平坦面とされており、略軸直角方向に広がっている。 Moreover, the opening end surface 32 which is an axial direction end surface at the side of the small-diameter cylindrical portion 18 of the housing 12 is an annular flat surface having a substantially constant width dimension and continuing to the entire circumferential direction, and spreads in a direction substantially perpendicular to the axis. Yes.
 弾性弁体14は、図7~9に示されているように、略一定の厚さ寸法を有する円板形状の中央部34と、中央部34の外周を全周に亘って囲む略円環形状を有する環状固定部36とを一体で備えており、全体として略ディスク形状とされている。弾性弁体14は、弾性を有する材料から形成されており、気密性や再封止性を考慮して、合成ゴム、天然ゴム、熱可塑性エラストマーなどから選択されるイソプレンゴムやシリコーンゴムなどの材料を用いて、プレス成形やモールド成形等によって形成される。 As shown in FIGS. 7 to 9, the elastic valve body 14 includes a disc-shaped central portion 34 having a substantially constant thickness dimension, and a substantially annular ring surrounding the outer periphery of the central portion 34 over the entire circumference. An annular fixing portion 36 having a shape is integrally provided, and is substantially disk-shaped as a whole. The elastic valve body 14 is formed of a material having elasticity, and is made of a material such as isoprene rubber or silicone rubber selected from synthetic rubber, natural rubber, thermoplastic elastomer and the like in consideration of airtightness and resealability. Is formed by press molding, molding, or the like.
 環状固定部36は、一定の略矩形断面形状をもって周方向に連続して延びている。この矩形断面は、径方向寸法(図9中、左右方向寸法)に比して、軸方向寸法(図9中、上下方向寸法)の方が大きくされている。なお、環状固定部36の軸方向寸法は、中央部34の軸方向寸法よりも小さくされており、環状固定部36の軸方向上端面が中央部34の軸方向上端面よりも内方(図9中の下方)に低くされている。これにより、後述するリング部材52が環状固定部36の軸方向上方に重ね合わされる際、中央部34がリング部材52よりも軸方向上方に突出するのが防止されている。 The annular fixing portion 36 continuously extends in the circumferential direction with a certain substantially rectangular cross-sectional shape. The rectangular cross section has an axial dimension (vertical dimension in FIG. 9) larger than a radial dimension (horizontal dimension in FIG. 9). Note that the axial dimension of the annular fixing portion 36 is smaller than the axial dimension of the central portion 34, and the axial upper end surface of the annular fixing portion 36 is inward of the axial upper end surface of the central portion 34 (see FIG. 9) (lower part of 9). This prevents the center portion 34 from protruding upward in the axial direction relative to the ring member 52 when a ring member 52 described later is superimposed on the upper side in the axial direction of the annular fixing portion 36.
 また、弾性弁体14の内面38に内環状凹溝42が形成されていると共に、外面40に外環状凹溝44が形成されている。内外の環状凹溝42,44は、略一定の凹状断面をもって全周に亘って連続しており、弾性弁体14の径方向で互いに略同じ位置に形成されている。これにより、弾性弁体14は内外の環状凹溝42,44の形成部分で厚さ寸法が小さくされており、弾性弁体14の内周部分を構成する中央部34と外周部分を構成する環状固定部36とを接続する括れ状部46が形成されている。また、括れ状部46は、弾性弁体14の厚さ方向でやや内面38寄りの位置に形成されており、弾性弁体14の中央部34は、括れ状部46よりも外面40側が内面38側よりも軸方向寸法を大きくされている。 Further, the inner annular groove 42 is formed on the inner surface 38 of the elastic valve body 14, and the outer annular groove 44 is formed on the outer surface 40. The inner and outer annular grooves 42 and 44 are continuous over the entire circumference with a substantially constant concave cross section, and are formed at substantially the same position in the radial direction of the elastic valve body 14. As a result, the thickness of the elastic valve body 14 is reduced at the portions where the inner and outer annular concave grooves 42 and 44 are formed, and the central portion 34 constituting the inner peripheral portion of the elastic valve body 14 and the annular portion constituting the outer peripheral portion. A constricted portion 46 that connects the fixed portion 36 is formed. Further, the constricted portion 46 is formed at a position slightly closer to the inner surface 38 in the thickness direction of the elastic valve body 14, and the central portion 34 of the elastic valve body 14 has an inner surface 38 on the outer surface 40 side than the constricted portion 46. The axial dimension is larger than the side.
 さらに、内面38における内環状凹溝42の内周側には、湾曲凹形の断面形状で全周に亘って連続して延びる凹溝部48が形成されており、内環状凹溝42の内周側の壁面に凹溝部48が開口している。 Further, on the inner peripheral side of the inner annular groove 42 on the inner surface 38, a concave groove portion 48 that continuously extends over the entire circumference with a curved concave sectional shape is formed. A concave groove 48 is opened in the side wall surface.
 なお、弾性弁体14の中央部34の直径は、好適には、5.0~6.5mmの範囲内で設定される。弾性弁体14の中央部34の直径が5.0mmよりも小さいと、外径が略4.0mmに統一された標準的なルアーロックコネクタ102のルアーチップ104の挿入が困難になる一方、直径が6.5mmよりも大きいと、第3の分岐開口部90の外径が大きくなって、標準的なルアーロックコネクタ102の雌ねじ部106との接続が困難となるからである。 The diameter of the central portion 34 of the elastic valve element 14 is preferably set within a range of 5.0 to 6.5 mm. If the diameter of the central portion 34 of the elastic valve body 14 is smaller than 5.0 mm, it becomes difficult to insert the luer tip 104 of the standard luer lock connector 102 whose outer diameter is unified to approximately 4.0 mm. Is larger than 6.5 mm, the outer diameter of the third branch opening 90 becomes large, and it becomes difficult to connect the female thread portion 106 of the standard luer lock connector 102.
 また、弾性弁体14の中央部34の厚さ寸法は、好適には、1.0~3.0mmの範囲内で設定される。中央部34の厚さ寸法が1.0mmよりも小さいと、シリンジ先端部等の雄コネクタの挿入時におけるシール性が不十分となるおそれがある一方、厚さ寸法が3.0mmよりも大きいと、雄コネクタの挿入抵抗が大きくなって、挿入操作が難しくなるおそれがあるからである。 The thickness dimension of the central portion 34 of the elastic valve body 14 is preferably set within a range of 1.0 to 3.0 mm. If the thickness dimension of the central part 34 is smaller than 1.0 mm, the sealing performance at the time of insertion of a male connector such as a syringe tip may be insufficient, while the thickness dimension is larger than 3.0 mm. This is because the insertion resistance of the male connector increases and the insertion operation may become difficult.
 中央部34には、厚さ方向に貫通するスリット50が形成されている。ここにおいて、スリット50の形状としては、例えば直線形状の他、十字などの放射形状が採用され、本実施形態においては、中央部34の中心から外周端縁部に至らない長さで径方向3方向に延びる放射形状とされている。なお、スリット50は、成形された弾性弁体14の厚さ方向に鋭利な刃を貫通させる等して形成される。また、スリット50は、後述する弾性弁体14のハウジング12への装着状態において、弾性弁体14の弾性に基づいて内面が相互に密着した遮断状態とされて、気密性が確保されている。 In the central portion 34, a slit 50 penetrating in the thickness direction is formed. Here, as the shape of the slit 50, for example, a linear shape or a radial shape such as a cross is adopted. In the present embodiment, the slit 50 has a length that does not reach the outer peripheral edge from the center of the central portion 34 in the radial direction 3. Radial shape extending in the direction. The slit 50 is formed by, for example, passing a sharp blade in the thickness direction of the molded elastic valve body 14. Further, the slit 50 is in a cut-off state in which the inner surfaces are in close contact with each other based on the elasticity of the elastic valve body 14 in a mounted state of the elastic valve body 14 to be described later, thereby ensuring airtightness.
 そして、弾性弁体14は、ハウジング12の開口部20に挿入されて、環状固定部36の内面が弁受座22で支持されることにより、ハウジング12の開口部20にセットされている。更に、弾性弁体14は、ハウジング12の開口部20に固着されるリング部材52によって、ハウジング12からの抜けが防止されている。 The elastic valve body 14 is set in the opening 20 of the housing 12 by being inserted into the opening 20 of the housing 12 and the inner surface of the annular fixing portion 36 being supported by the valve seat 22. Further, the elastic valve body 14 is prevented from being detached from the housing 12 by a ring member 52 fixed to the opening 20 of the housing 12.
 リング部材52は、熱可塑性樹脂で形成された硬質の部材であって、図10~12に示すように、周方向に略一定の断面形状で連続している。また、リング部材52は、ハウジング12の開口部20の内径寸法と略同じ外径寸法を有する内周挟持部54と、ハウジング12の開口端面32の外径寸法と略同じ外径寸法を有する外周固着部56とを、一体で備えている。 The ring member 52 is a hard member formed of a thermoplastic resin, and is continuous with a substantially constant cross-sectional shape in the circumferential direction as shown in FIGS. Further, the ring member 52 has an inner periphery holding portion 54 having an outer diameter dimension substantially the same as the inner diameter dimension of the opening 20 of the housing 12 and an outer periphery having an outer diameter dimension substantially the same as the outer diameter dimension of the opening end surface 32 of the housing 12. The fixing portion 56 is integrally provided.
 リング部材52の内周挟持部54には、嵌合凸部58が設けられている。嵌合凸部58は、略一定の断面形状で全周に亘って連続して延びており、外周固着部56の下面よりも下方まで突出して外周固着部56との間で段差をなしていると共に、外径寸法がハウジング12の開口部20の内径寸法と略同じとされている。また、環状とされた嵌合凸部58の外周面は、軸方向に延びる略円筒面とされており、ハウジング12の開口部20の内径寸法と略同じ外径寸法で形成されている。更に、嵌合凸部58の突出先端の外周縁部は、突出先端に向かって次第に内周側に傾斜するテーパ形状とされて、嵌合凸部58の突出先端部が先細形状とされており、嵌合凸部58の突出先端がハウジング12の開口部20の内径寸法よりも小径とされている。 A fitting convex portion 58 is provided on the inner peripheral clamping portion 54 of the ring member 52. The fitting convex portion 58 has a substantially constant cross-sectional shape and continuously extends over the entire circumference, protrudes below the lower surface of the outer peripheral fixing portion 56 and forms a step with the outer peripheral fixing portion 56. In addition, the outer diameter dimension is substantially the same as the inner diameter dimension of the opening 20 of the housing 12. Further, the outer peripheral surface of the annular fitting convex portion 58 is a substantially cylindrical surface extending in the axial direction, and is formed with an outer diameter that is substantially the same as the inner diameter of the opening 20 of the housing 12. Further, the outer peripheral edge portion of the projecting tip of the fitting convex portion 58 is tapered so as to gradually incline toward the projecting tip, and the projecting tip portion of the fitting convex portion 58 is tapered. The protruding tip of the fitting projection 58 is smaller in diameter than the inner diameter of the opening 20 of the housing 12.
 更にまた、リング部材52の内周挟持部54には、環状凸部60が設けられている。環状凸部60は、リング部材52の内周縁部に設けられて、嵌合凸部58よりも下方まで突出しており、弾性弁体14の外環状凹溝44に差入れ可能な断面形状で周方向の全周に亘って連続している。また、環状凸部60は、内周面が突出先端に向かって次第に大径となるテーパ形状とされており、突出先端に向かって径方向で薄肉となっている。 Furthermore, an annular convex portion 60 is provided on the inner peripheral clamping portion 54 of the ring member 52. The annular convex portion 60 is provided on the inner peripheral edge portion of the ring member 52, protrudes below the fitting convex portion 58, and has a cross-sectional shape that can be inserted into the outer annular concave groove 44 of the elastic valve body 14 in the circumferential direction. It is continuous over the entire circumference. Moreover, the annular convex part 60 is made into the taper shape from which an internal peripheral surface becomes gradually large diameter toward a protrusion front-end | tip, and is thin in radial direction toward a protrusion front-end | tip.
 また、リング部材52の外周固着部56は、略軸直角方向に広がる下面を有しており、下方に突出する溶着凸部62を備えている。溶着凸部62は、外周固着部56の径方向中間部分に突設された凸部であって、突出先端に向かって次第に狭幅となる略一定の断面形状をもって、略均一な突出高さ(後述する当接面64から突出先端面までの長さ)で周方向の全周に亘って連続している。更に、溶着凸部62は、嵌合凸部58に対して外周側に所定距離を隔てて設けられていると共に、突出高さが嵌合凸部58よりも小さくされている。 Further, the outer peripheral fixing portion 56 of the ring member 52 has a lower surface that extends in a direction substantially perpendicular to the axis, and includes a welding convex portion 62 that protrudes downward. The welding convex portion 62 is a convex portion projecting from the radially intermediate portion of the outer periphery fixing portion 56, and has a substantially constant cross-sectional shape that becomes gradually narrower toward the projecting tip, and has a substantially uniform projecting height ( It is continuous over the entire circumference in the circumferential direction with a length from a contact surface 64 (described later) to a protruding tip surface. Further, the welding convex portion 62 is provided at a predetermined distance on the outer peripheral side with respect to the fitting convex portion 58, and the protruding height is made smaller than that of the fitting convex portion 58.
 また、溶着凸部62の内周側には、ハウジング12に対する重ね合わせ面である外周固着部56の下面を構成する当接面64が形成されている。この当接面64は、全周に亘って略一定の幅寸法で延びて略軸直角方向に広がる環状の平坦面であって、溶着凸部62と嵌合凸部58の径方向間に設けられて、嵌合凸部58よりも上方に位置している。なお、溶着凸部62の外周側では、外周固着部56の下面が当接面64よりも上方に位置しており、外周固着部56の最外周端部が当接面64の形成部分よりも薄肉とされている。 Further, on the inner peripheral side of the welding convex portion 62, a contact surface 64 constituting the lower surface of the outer peripheral fixing portion 56, which is an overlapping surface with respect to the housing 12, is formed. The contact surface 64 is an annular flat surface that extends with a substantially constant width over the entire circumference and extends in a direction substantially perpendicular to the axis, and is provided between the welding convex portion 62 and the fitting convex portion 58 in the radial direction. And located above the fitting convex portion 58. Note that, on the outer peripheral side of the welding convex portion 62, the lower surface of the outer peripheral fixing portion 56 is located above the contact surface 64, and the outermost peripheral end portion of the outer peripheral fixing portion 56 is more than the portion where the contact surface 64 is formed. It is said to be thin.
 そして、ハウジング12の開口部20に弾性弁体14がセットされた状態で、ハウジング12の開口部20にリング部材52が固着されて、リング部材52の内周部分が弾性弁体14の外周部分の外面に重ね合わされる。これにより、弾性弁体14の外周部分がハウジング12とリング部材52の間で軸方向に挟持されて、医療用コネクタ10が形成されている。なお、本実施形態では、弾性弁体14の環状固定部36がハウジング12の弁受座22とリング部材52の内周挟持部54との間で軸方向に挟持されている一方、ハウジング12の係止凸部24が弾性弁体14の内環状凹溝42に差し入れられて係止されていると共に、リング部材52の環状凸部60が弾性弁体14の外環状凹溝44に差し入れられて係止されている。 Then, with the elastic valve element 14 set in the opening 20 of the housing 12, the ring member 52 is fixed to the opening 20 of the housing 12, and the inner peripheral portion of the ring member 52 is the outer peripheral portion of the elastic valve element 14. Is overlaid on the outer surface. Thereby, the outer peripheral part of the elastic valve body 14 is clamped in the axial direction between the housing 12 and the ring member 52, and the medical connector 10 is formed. In the present embodiment, the annular fixing portion 36 of the elastic valve body 14 is clamped in the axial direction between the valve seat 22 of the housing 12 and the inner peripheral clamping portion 54 of the ring member 52, while the housing 12 The locking projection 24 is inserted and locked into the inner annular groove 42 of the elastic valve body 14, and the annular projection 60 of the ring member 52 is inserted into the outer annular groove 44 of the elastic valve body 14. It is locked.
 ところで、本実施形態の医療用コネクタ10は、ハウジング12とリング部材52を固着して、ハウジング12とリング部材52の間で弾性弁体14を挟持させる際に、ハウジング12とリング部材52が相互に位置決めされた状態で強固に固着されるようになっている。以下、図13~17を参照しながら、医療用コネクタ10の製造工程を説明する。 By the way, when the medical connector 10 of this embodiment fixes the housing 12 and the ring member 52 and clamps the elastic valve body 14 between the housing 12 and the ring member 52, the housing 12 and the ring member 52 are mutually connected. It is firmly fixed in a state where it is positioned on. Hereinafter, the manufacturing process of the medical connector 10 will be described with reference to FIGS.
 先ず、熱可塑性樹脂製のハウジング12を準備する。このハウジング12は、上述のように、全体として筒状とされており、開口部20の内周側には、ディスク状とされた弾性弁体14の外周部分を支持する弁受座22が形成されている。なお、ハウジング12は、例えば、熱可塑性樹脂の射出成形やモールド成形などによって得ることができる。以上により、ハウジング準備工程を完了する。 First, a housing 12 made of thermoplastic resin is prepared. As described above, the housing 12 has a tubular shape as a whole, and a valve seat 22 that supports the outer peripheral portion of the disc-shaped elastic valve body 14 is formed on the inner peripheral side of the opening 20. Has been. The housing 12 can be obtained by, for example, injection molding or molding of a thermoplastic resin. Thus, the housing preparation process is completed.
 また、熱可塑性樹脂製のリング部材52を準備する。リング部材52は、ハウジング12の開口部20に取り付けられることで、弾性弁体14の外周部分をハウジング12の弁受座22との間で挟持するようになっている。なお、リング部材52は、ハウジング12と同様に、熱可塑性樹脂の射出成形やモールド成形によって得ることができる。以上により、リング部材準備工程を完了する。 Also, a ring member 52 made of thermoplastic resin is prepared. The ring member 52 is attached to the opening 20 of the housing 12 so as to sandwich the outer peripheral portion of the elastic valve body 14 with the valve seat 22 of the housing 12. The ring member 52 can be obtained by injection molding or molding of a thermoplastic resin, like the housing 12. The ring member preparation process is thus completed.
 また、図13~16の(a),(b)に示すように、予め準備された弾性弁体14の外周部分を、ハウジング12の弁受座22で支持させて、ハウジング12の開口部20にセットする。より具体的には、弾性弁体14の環状固定部36をハウジング12の弁受座22の嵌合凹溝26に挿入すると共に、弁受座22の係止凸部24を弾性弁体14の内環状凹溝42に挿入係止させることで、弾性弁体14をハウジング12の開口部20内で位置決めしてセットする。以上により、弁体セット工程を完了する。なお、環状固定部36と嵌合凹溝26の内面とを接着剤などで固着して、シール性の向上を図ることも可能であるが、本実施形態では非固着で差し入れられている。 Further, as shown in FIGS. 13 to 16 (a) and (b), the outer peripheral portion of the elastic valve body 14 prepared in advance is supported by the valve seat 22 of the housing 12, and the opening portion 20 of the housing 12. Set to. More specifically, the annular fixing portion 36 of the elastic valve body 14 is inserted into the fitting concave groove 26 of the valve receiving seat 22 of the housing 12, and the locking convex portion 24 of the valve receiving seat 22 is inserted into the elastic valve body 14. The elastic valve element 14 is positioned and set in the opening 20 of the housing 12 by being inserted and locked in the inner annular groove 42. Thus, the valve body setting process is completed. Although it is possible to improve the sealing performance by fixing the annular fixing portion 36 and the inner surface of the fitting concave groove 26 with an adhesive or the like, in the present embodiment, it is inserted without fixing.
 次に、図13~16の(c)に示すように、弾性弁体14が設置されたハウジング12の開口端面32にリング部材52を重ね合わせる。より詳細には、リング部材52の環状凸部60を弾性弁体14の外環状凹溝44に挿入して、リング部材52をハウジング12に対して径方向で位置決めしながら、リング部材52をハウジング12に対して接近させることで、リング部材52の外周固着部56に突設された溶着凸部62をハウジング12の開口端面32に当接させる。なお、本実施形態では、溶着凸部62とハウジング12の開口端面32との当接前に、リング部材52の嵌合凸部58がハウジング12の開口部20に挿し入れられて、ハウジング12の開口部20の内周面に対して径方向に位置決めされるようになっている。 Next, as shown in FIGS. 13 to 16C, a ring member 52 is overlapped on the open end surface 32 of the housing 12 in which the elastic valve body 14 is installed. More specifically, the annular member 60 is inserted into the outer annular groove 44 of the elastic valve body 14 so that the ring member 52 is positioned in the radial direction with respect to the housing 12 while the ring member 52 is positioned in the housing. 12, the welding convex portion 62 protruding from the outer peripheral fixing portion 56 of the ring member 52 is brought into contact with the opening end surface 32 of the housing 12. In the present embodiment, the fitting convex portion 58 of the ring member 52 is inserted into the opening portion 20 of the housing 12 before the welding convex portion 62 and the opening end surface 32 of the housing 12 are in contact with each other. It is positioned in the radial direction with respect to the inner peripheral surface of the opening 20.
 さらに、ハウジング12の開口端面32にリング部材52を重ね合わせた状態で、開口端面32に当接された溶着凸部62を溶融させる。即ち、図15,16の(c),(c’)および図17に示すように、ホーン70をリング部材52に押し当てて、リング部材52の溶着凸部62に超音波振動をおよぼすことで、溶着凸部62の先端面とハウジング12の開口端面32との当接部に摩擦熱を生ぜしめて、溶着凸部62とハウジング12の開口端面32との当接部を溶融させる。本実施形態では、リング部材52の嵌合凸部58をハウジング12の開口部20に挿し入れた状態で、溶着凸部62の当接部を溶融させることで、ハウジング12とリング部材52が径方向に位置決めされた状態で溶着凸部62を溶融させることが可能となっている。また、ホーン70からリング部材52に伝達される超音波振動の周波数を適宜に調節して、リング部材52の溶着凸部62だけが溶融されるように設定することで、溶着凸部62を外れた内周側においてハウジング12およびリング部材52の溶融を防いで形状を保持する。以上のように、溶融工程を行う。 Further, the welding projection 62 abutted on the opening end surface 32 is melted in a state where the ring member 52 is superimposed on the opening end surface 32 of the housing 12. That is, as shown in FIGS. 15 and 16 (c), (c ′) and FIG. 17, the horn 70 is pressed against the ring member 52 to apply ultrasonic vibration to the welded convex portion 62 of the ring member 52. Then, frictional heat is generated at the contact portion between the tip end surface of the welding convex portion 62 and the opening end surface 32 of the housing 12 to melt the contact portion between the welding convex portion 62 and the opening end surface 32 of the housing 12. In the present embodiment, the housing 12 and the ring member 52 have a diameter by melting the contact portion of the welding convex portion 62 in a state where the fitting convex portion 58 of the ring member 52 is inserted into the opening portion 20 of the housing 12. It is possible to melt the welding convex portion 62 in a state positioned in the direction. Further, by appropriately adjusting the frequency of the ultrasonic vibration transmitted from the horn 70 to the ring member 52 and setting so that only the welding convex portion 62 of the ring member 52 is melted, the welding convex portion 62 is removed. Further, the housing 12 and the ring member 52 are prevented from melting on the inner peripheral side and the shape is maintained. As described above, the melting step is performed.
 なお、ハウジング12とリング部材52の接近変位時に、嵌合凸部58の外周面がハウジング12における開口部20の内周面に摺接しながら移動することで、ハウジング12とリング部材52が径方向に位置ずれすることなく溶着される。このことからも明らかなように、ハウジング12とリング部材52の接近変位をガイドするガイド部が、嵌合凸部58によって構成されている。 In addition, when the housing 12 and the ring member 52 approach each other, the housing 12 and the ring member 52 move in the radial direction because the outer peripheral surface of the fitting convex portion 58 moves while sliding on the inner peripheral surface of the opening 20 in the housing 12. It is welded without displacement. As is clear from this, the guide portion for guiding the approaching displacement between the housing 12 and the ring member 52 is constituted by the fitting convex portion 58.
 本実施形態では、加熱溶融された溶着凸部62の樹脂を、溶着凸部62を外れた外周側に入り込ませることで、ハウジング12の開口端面32とリング部材52をより強固に固着させているが、例えば、溶着凸部62の外周側では、ハウジング12とリング部材52が隙間をもって軸方向に対向配置されていても良い。また、溶着凸部62の先端面がハウジング12の開口端面32に当接された状態で、ハウジング12とリング部材52が溶着凸部62を外れた内外周両側において隙間をもって軸方向に対向しており、該隙間は、開口端面32と外周固着部56との対向面間から溶着凸部62の溶融樹脂がはみ出すのを防ぐスペースとしても機能するようになっている。 In the present embodiment, the opening end face 32 of the housing 12 and the ring member 52 are more firmly fixed by causing the resin of the welding convex portion 62 that has been heated and melted to enter the outer peripheral side outside the welding convex portion 62. However, for example, the housing 12 and the ring member 52 may be arranged to face each other in the axial direction with a gap on the outer peripheral side of the welding projection 62. Further, the housing 12 and the ring member 52 are opposed to each other in the axial direction with a gap on both the inner and outer circumferences outside the welding projection 62 in a state where the tip end surface of the welding projection 62 is in contact with the opening end surface 32 of the housing 12. The gap functions as a space for preventing the molten resin of the welding convex portion 62 from protruding from between the opposing surfaces of the opening end surface 32 and the outer peripheral fixing portion 56.
 また次に、溶融工程における溶着凸部62の溶融状態下で、溶着凸部62が潰れて、相互に重ね合わされるハウジング12の開口端面32とリング部材52の下面との当接面積が増大するまで、ハウジング12とリング部材52を接近方向へ押圧する。即ち、本実施形態では、溶着凸部62が潰れて、リング部材52の当接面64がハウジング12の開口端面32に当接することで、ハウジング12とリング部材52の当接面積が増大するまで、ハウジング12とリング部材52を接近方向へ押圧する。なお、本実施形態では、リング部材52の嵌合凸部58をハウジング12の開口部20に挿し入れながらリング部材52をハウジング12に対して接近方向に押圧することで、リング部材52をハウジング12に対して位置決めしながら接近させることができる。 Next, under the molten state of the welding convex portion 62 in the melting step, the welding convex portion 62 is crushed, and the contact area between the opening end surface 32 of the housing 12 and the lower surface of the ring member 52 that are overlapped with each other increases. Until the housing 12 and the ring member 52 are pressed in the approaching direction. That is, in this embodiment, until the welding convex part 62 is crushed and the contact surface 64 of the ring member 52 contacts the opening end surface 32 of the housing 12, the contact area between the housing 12 and the ring member 52 increases. Then, the housing 12 and the ring member 52 are pressed in the approaching direction. In the present embodiment, the ring member 52 is pressed in the approaching direction against the housing 12 while the fitting convex portion 58 of the ring member 52 is inserted into the opening 20 of the housing 12, so that the ring member 52 is moved to the housing 12. Can be made to approach while positioning.
 さらに、リング部材52をハウジング12に対して接近方向に押圧することで、弾性弁体14の内外の環状凹溝42,44に対してハウジング12の係止凸部24とリング部材52の環状凸部60とを押し入れて嵌め合わせる。これにより、弾性弁体14の外周部分において、環状固定部36をハウジング12の弁受座22とリング部材52の嵌合凸部58との間で挟んで圧縮変形させると共に、括れ状部46をハウジング12の係止凸部24とリング部材52の環状凸部60との間で挟んで必要に応じて圧縮変形させる。 Further, by pressing the ring member 52 in the approaching direction with respect to the housing 12, the locking convex portion 24 of the housing 12 and the annular convexity of the ring member 52 against the inner and outer annular concave grooves 42 and 44 of the elastic valve body 14. Push in part 60 and fit. As a result, the annular fixing portion 36 is sandwiched between the valve seat 22 of the housing 12 and the fitting convex portion 58 of the ring member 52 at the outer peripheral portion of the elastic valve body 14 and is compressed and deformed. It is sandwiched between the locking projection 24 of the housing 12 and the annular projection 60 of the ring member 52 and is compressed and deformed as necessary.
 そして、図15,16の(d)および図17の(b)に示すように、ハウジング12とリング部材52を接近方向へ押圧した状態に保持して、溶融した溶着凸部62の当接部を冷却固化させることにより、それらハウジング12とリング部材52を溶着凸部62の当接部において溶融一体化して、一体的に連結固着する。本実施形態では、溶着凸部62を全周に亘って溶融させることで、ハウジング12とリング部材52を全周に亘って連続的に固着する。これにより、ハウジング12の開口部20にセットされた弾性弁体14の外周部分を、ハウジング12の弁受座22とリング部材52の間で挟持させて、溶融工程および弁体固定工程が完了する。本実施形態では、ハウジング12の弁受座22とリング部材52の嵌合凸部58との間で弾性弁体14の環状固定部36を挟持させると共に、ハウジング12の係止凸部24とリング部材52の環状凸部60との間で弾性弁体14の括れ状部46を挟持させる。以上により、医療用コネクタの製造工程を完了して、本実施形態に係る医療用コネクタ10を得ることができる。 Then, as shown in FIGS. 15 and 16 (d) and FIG. 17 (b), the housing 12 and the ring member 52 are held in a pressed state in the approaching direction, and the contact portion of the melted welding convex portion 62 is held. By cooling and solidifying, the housing 12 and the ring member 52 are fused and integrated at the contact portion of the welding projection 62, and are integrally connected and fixed. In the present embodiment, the housing 12 and the ring member 52 are continuously fixed over the entire circumference by melting the welding convex portion 62 over the entire circumference. Thereby, the outer peripheral part of the elastic valve body 14 set in the opening 20 of the housing 12 is sandwiched between the valve seat 22 of the housing 12 and the ring member 52, and the melting process and the valve body fixing process are completed. . In the present embodiment, the annular fixing portion 36 of the elastic valve body 14 is sandwiched between the valve seat 22 of the housing 12 and the fitting convex portion 58 of the ring member 52, and the locking convex portion 24 and the ring of the housing 12 are sandwiched. The constricted portion 46 of the elastic valve body 14 is sandwiched between the annular convex portion 60 of the member 52. By the above, the manufacturing process of a medical connector can be completed and the medical connector 10 which concerns on this embodiment can be obtained.
 このようにして製造される医療用コネクタ10は、図17(b)に示すように、リング部材52の溶着凸部62とハウジング12の開口端面32との当接部分が、超音波溶着によって溶融一体化された溶着部66とされて、溶着部66が全周に亘って連続して設けられている。一方、溶着凸部62を径方向に外れた内周側には、形状を略維持されたハウジング12の開口端面32とリング部材52の当接面64とが軸方向で相互に当接する位置決め部68が、全周に亘って連続して設けられている。なお、溶融した溶着凸部62の樹脂が位置決め部68に入り込むことで、ハウジング12の開口端面32とリング部材52の当接面64とが位置決め部68で間接的に当接すると共に、ハウジング12とリング部材52が位置決め部68において接着されていても良い。 In the medical connector 10 manufactured in this way, as shown in FIG. 17B, the contact portion between the welding convex portion 62 of the ring member 52 and the opening end surface 32 of the housing 12 is melted by ultrasonic welding. The weld portion 66 is integrated, and the weld portion 66 is continuously provided over the entire circumference. On the other hand, on the inner peripheral side where the welding projection 62 is radially removed, the positioning portion where the opening end surface 32 of the housing 12 and the contact surface 64 of the ring member 52 that are substantially maintained in shape are in contact with each other in the axial direction. 68 is continuously provided over the entire circumference. In addition, when the molten resin of the welding convex portion 62 enters the positioning portion 68, the opening end surface 32 of the housing 12 and the abutting surface 64 of the ring member 52 indirectly abut on the positioning portion 68, and the housing 12 The ring member 52 may be bonded at the positioning portion 68.
 本実施形態では、リング部材52における溶着凸部62を内周側と外周側とにそれぞれ外れた部分に環状の平坦面が設けられており、これら内外周の平坦面上で溶着凸部62が完全に溶けることで、ハウジング12に対して平坦状の面と面で重ね合わされて、溶融を阻止して位置決めし得るようになっている。 In the present embodiment, annular flat surfaces are provided at portions where the welding convex portions 62 of the ring member 52 are separated from the inner peripheral side and the outer peripheral side, respectively, and the welding convex portions 62 are formed on the inner and outer peripheral flat surfaces. By being completely melted, the housing 12 is superposed on a flat surface with a flat surface so as to be positioned while preventing melting.
 このような構造とされた本実施形態に係る医療用コネクタ10によれば、位置決め部68においてハウジング12の開口端面32とリング部材52の当接面64が相互に当接することで、ハウジング12とリング部材52が軸方向で高精度に位置決めされる。それ故、ハウジング12の弁受座22とリング部材52の内周挟持部54との過剰な接近が回避されて、ハウジング12とリング部材52の間で挟持される弾性弁体14の過大な弾性変形が防止されることから、目的とする弾性弁体14の変形特性(ばね特性)や耐久性などを有効に得ることができる。特に、弾性弁体14の外周部分がハウジング12とリング部材52の間で挟持された状態において、環状固定部36に比して薄肉とされた括れ状部46の厚さ寸法が安定して設定されることから、括れ状部46が係止凸部24と環状凸部60の間で強く挟み込まれて破断したり耐久性が低下するといった不具合を回避して、品質の安定性と向上が図られる。 According to the medical connector 10 according to the present embodiment having such a structure, the opening end surface 32 of the housing 12 and the contact surface 64 of the ring member 52 are in contact with each other in the positioning portion 68, so that the housing 12 The ring member 52 is positioned with high accuracy in the axial direction. Therefore, excessive approach between the valve seat 22 of the housing 12 and the inner peripheral clamping portion 54 of the ring member 52 is avoided, and excessive elasticity of the elastic valve body 14 held between the housing 12 and the ring member 52 is obtained. Since deformation is prevented, the desired deformation characteristics (spring characteristics) and durability of the elastic valve body 14 can be obtained effectively. In particular, in a state where the outer peripheral portion of the elastic valve body 14 is sandwiched between the housing 12 and the ring member 52, the thickness dimension of the constricted portion 46 which is thinner than the annular fixing portion 36 is set stably. Therefore, the problem that the constricted portion 46 is strongly sandwiched between the locking convex portion 24 and the annular convex portion 60 and is broken or the durability is lowered is avoided, and the stability and improvement of the quality are achieved. It is done.
 また、溶着凸部62の内周側と外周側でハウジング12の開口端面32とリング部材52の外周固着部56との対向面間距離が異ならされている。特に、内周側よりも対向面間距離が大きい外周側で、開口端面32と外周固着部56の対向面積が大きくされている。これにより、ハウジング12とリング部材52の溶着に際して、内周側の対向面で開口端面32と外周固着部56(当接面64)が直接に当接することで、又は内周側の対向面間に入って充填状態とされた溶融樹脂を介して開口端面32と外周固着部56が間接に当接することで、ハウジング12とリング部材52の接近方向の位置が規定される。万一、更に溶融工程および弁体固定工程が継続された場合には、外周側で控えた開口端面32と外周固着部56の対向面がより大きな面積で直接又は間接に当接することにより、ハウジング12とリング部材52の接近方向の相対位置が確実に規定されて過度の接近が防止され得る。 Further, the distance between the facing surfaces of the opening end surface 32 of the housing 12 and the outer peripheral fixing portion 56 of the ring member 52 is different between the inner peripheral side and the outer peripheral side of the welding convex portion 62. In particular, the facing area of the opening end surface 32 and the outer peripheral fixing portion 56 is increased on the outer peripheral side where the distance between the opposing surfaces is larger than that on the inner peripheral side. Thereby, when the housing 12 and the ring member 52 are welded, the opening end surface 32 and the outer peripheral fixing portion 56 (contact surface 64) directly contact each other on the inner peripheral surface or between the inner peripheral surfaces. The position of the housing 12 and the ring member 52 in the approaching direction is defined by the abutment of the opening end surface 32 and the outer peripheral fixing portion 56 indirectly through the molten resin that has been filled. In the unlikely event that the melting step and the valve body fixing step are further continued, the opposing surface of the opening end surface 32 and the outer peripheral fixing portion 56 withdrawn on the outer peripheral side directly or indirectly abuts on a larger area, so that the housing The relative position in the approach direction between the ring member 12 and the ring member 52 can be reliably defined, and excessive approach can be prevented.
 また、ハウジング12とリング部材52は、溶着部66において溶融して一体的に連結固着されることで強固に固定されて、実質的に分離不能とされていることから、弾性弁体14がハウジング12とリング部材52の間で安定して支持される。 In addition, the housing 12 and the ring member 52 are firmly fixed by being melted and integrally connected and fixed at the welded portion 66, so that the elastic valve body 14 is substantially inseparable. 12 and the ring member 52 are stably supported.
 さらに、溶着部66がハウジング12およびリング部材52の周方向で全周に亘って連続して設けられており、ハウジング12とリング部材52が全周に亘って相互に固着されていることにより、ハウジング12とリング部材52の溶着面積が大きく確保されてより強固に固着される。 Furthermore, the welding part 66 is provided continuously over the entire circumference in the circumferential direction of the housing 12 and the ring member 52, and the housing 12 and the ring member 52 are fixed to each other over the entire circumference. A large welding area is secured between the housing 12 and the ring member 52 and the housing 12 and the ring member 52 are firmly fixed.
 しかも、溶着部66の内周側には位置決め部68が全周に亘って環状に設けられており、ハウジング12とリング部材52が全周に亘って連続的に当接することで、位置決め作用が発揮されるようになっている。従って、ハウジング12とリング部材52が相対的に傾斜した状態で固定されるのを防いで、ハウジング12とリング部材52の間で弾性弁体14を安定して挟持することができる。 In addition, a positioning portion 68 is provided on the inner peripheral side of the welded portion 66 in an annular shape over the entire circumference, and the positioning action is achieved by the housing 12 and the ring member 52 continuously contacting over the entire circumference. It has come to be demonstrated. Therefore, the housing 12 and the ring member 52 can be prevented from being fixed in a relatively inclined state, and the elastic valve body 14 can be stably held between the housing 12 and the ring member 52.
 また、リング部材52の内周挟持部54に設けられた嵌合凸部58がハウジング12に挿し入れられて、嵌合凸部58の外周面がハウジング12の内周面に実質的に当接した状態で重ね合わされている。これにより、リング部材52がハウジング12に対して径方向で位置決めされて、リング部材52がハウジング12に対して適切な位置に取り付けられると共に、溶着凸部62の溶融樹脂がハウジング12の内周側に流れ込むのが防止されて、弾性弁体14が溶着時の熱から保護される。加えて、嵌合凸部58とハウジング12の開口部20の内周面との重ね合わせ面間に溶融樹脂が入り込むことで、ハウジング12とリング部材52のより強固な固着も期待できる。 Further, the fitting convex portion 58 provided on the inner peripheral clamping portion 54 of the ring member 52 is inserted into the housing 12, and the outer peripheral surface of the fitting convex portion 58 substantially contacts the inner peripheral surface of the housing 12. It is piled up in the state which did. Thereby, the ring member 52 is positioned in the radial direction with respect to the housing 12, the ring member 52 is attached to an appropriate position with respect to the housing 12, and the molten resin of the welding projection 62 is on the inner peripheral side of the housing 12 The elastic valve body 14 is protected from heat during welding. In addition, since the molten resin enters between the overlapping surfaces of the fitting convex portion 58 and the inner peripheral surface of the opening portion 20 of the housing 12, stronger fixation between the housing 12 and the ring member 52 can be expected.
 さらに、図3に示されているように、ハウジング12において弾性弁体14の環状固定部36を収容する開口部20の外周壁は、環状固定部36よりも高くされており、弾性弁体14の環状固定部36の外周面の全面がハウジング12の開口部20の外周壁によって覆われている。そして、ハウジング12の開口部20の外周壁の先端面(開口端面)32におけるリング部材52との溶着部位が、弾性弁体14の環状固定部36から上方に離れた位置に設定されている。 Further, as shown in FIG. 3, the outer peripheral wall of the opening 20 that accommodates the annular fixing portion 36 of the elastic valve body 14 in the housing 12 is made higher than the annular fixing portion 36. The entire outer peripheral surface of the annular fixing portion 36 is covered with the outer peripheral wall of the opening 20 of the housing 12. And the welding site | part with the ring member 52 in the front end surface (opening end surface) 32 of the outer peripheral wall of the opening part 20 of the housing 12 is set in the position away from the cyclic | annular fixing | fixed part 36 of the elastic valve body 14 upwards.
 これにより、ハウジング12とリング部材52との溶着に際して、仮にハウジング12の開口端面32とリング部材52の溶着突部62との重ね合わせ面から溶融樹脂が内周側にはみ出たとしても、溶融樹脂が弾性弁体14の環状固定部36の外周面等を直接に押圧する事態が生じにくくされている。また、リング部材52に設けられたガイド部(嵌合凸部58)により、溶融樹脂が弾性弁体14の環状固定部36の外周面等を直接に押圧する事態をなくしている。このため、弾性弁体14の保持状態が安定して維持されると共に、溶融樹脂が弾性弁体14の耐久性などに悪影響を及ぼすこともない。特に本実施形態では、ハウジング12とリング部材52との溶着部位と弾性弁体14の環状固定部36との間に、リング部材52の嵌合凸部58とハウジング12の開口部20への全周に亘る嵌合部が設けられていることから、溶融樹脂の弾性弁体14への接触が一層効果的に防止されるようになっている。 Thereby, when the housing 12 and the ring member 52 are welded, even if the molten resin protrudes from the overlapping surface of the opening end surface 32 of the housing 12 and the welding projection 62 of the ring member 52 to the inner peripheral side, the molten resin However, it is difficult to cause a situation in which the outer peripheral surface of the annular fixing portion 36 of the elastic valve body 14 is directly pressed. Further, the guide portion (fitting convex portion 58) provided on the ring member 52 eliminates a situation in which the molten resin directly presses the outer peripheral surface of the annular fixing portion 36 of the elastic valve body 14 and the like. For this reason, the holding state of the elastic valve body 14 is stably maintained, and the molten resin does not adversely affect the durability of the elastic valve body 14. In particular, in this embodiment, between the welded portion of the housing 12 and the ring member 52 and the annular fixing portion 36 of the elastic valve body 14, the fitting protrusion 58 of the ring member 52 and the entire opening 20 of the housing 12 are all. Since the fitting part over the circumference is provided, the contact of the molten resin with the elastic valve body 14 is more effectively prevented.
 また、リング部材52に突設された環状凸部60が弾性弁体14の外環状凹溝44に差し入れられることから、リング部材52の嵌合凸部58がハウジング12に挿入される前にリング部材52がハウジング12に対して軸直角方向で仮に位置決めされるようになっている。それ故、硬質の嵌合凸部58を硬質のハウジング12に嵌め入れ易くなっており、ハウジング12とリング部材52の軸直角方向での位置決めが容易である。 Further, since the annular convex portion 60 protruding from the ring member 52 is inserted into the outer annular concave groove 44 of the elastic valve body 14, the ring convex portion 58 of the ring member 52 is inserted into the housing 12 before being inserted into the housing 12. The member 52 is temporarily positioned with respect to the housing 12 in the direction perpendicular to the axis. Therefore, it is easy to fit the hard fitting convex portion 58 into the hard housing 12, and the housing 12 and the ring member 52 can be easily positioned in the direction perpendicular to the axis.
 しかも、ハウジング12とリング部材52が固定された状態では、内環状凹溝42にハウジング12の係止凸部24が嵌め入れられて係止されていると共に、外環状凹溝44にリング部材52の環状凸部60が嵌め入れられて係止されている。これにより、弾性弁体14の環状固定部36がハウジング12の弁受座22とリング部材52の嵌合凸部58との間で挟持される際に、環状固定部36の内周側への膨出変形が係止凸部24と環状凸部60によって制限されている。従って、ハウジング12における開口部20の内周面および嵌合凹溝26の内面と、リング部材52の嵌合凸部58の先端面とに、環状固定部36が押し当てられて、環状固定部36とハウジング12およびリング部材52との重ね合わせ面間が封止される。 In addition, in a state where the housing 12 and the ring member 52 are fixed, the locking projection 24 of the housing 12 is fitted and locked in the inner annular groove 42 and the ring member 52 is locked in the outer annular groove 44. The annular projection 60 is fitted and locked. As a result, when the annular fixing portion 36 of the elastic valve body 14 is sandwiched between the valve seat 22 of the housing 12 and the fitting convex portion 58 of the ring member 52, the annular fixing portion 36 faces the inner peripheral side. The bulging deformation is limited by the locking projection 24 and the annular projection 60. Accordingly, the annular fixing portion 36 is pressed against the inner peripheral surface of the opening 20 in the housing 12 and the inner surface of the fitting concave groove 26 and the front end surface of the fitting convex portion 58 of the ring member 52, and the annular fixing portion. The overlapping surface of 36, the housing 12, and the ring member 52 is sealed.
 なお、医療用コネクタ10は、図18,19に示すように、例えば三方活栓72の混注ポートとして用いられる。三方活栓72は、ホルダ74にコック76が取り付けられた構造とされている。 The medical connector 10 is used as, for example, a mixed injection port of a three-way stopcock 72 as shown in FIGS. The three-way cock 72 has a structure in which a cock 76 is attached to a holder 74.
 より詳細には、ホルダ74は、略円筒形状を有する本体部78と、本体部78の外周から突出する第1~第3の3本の分岐管80,82,84を備えた中空構造の一体成形品とされている。これら第1~第3の分岐管80,82,84は、軸方向一方の端部が本体部78と接続されて本体部78の内部空間に連通されていると共に、他方の端部が、図19に破線でモデル的に示すように、外部空間に連通する第1~第3の分岐開口部86,88,90とされている。これにより、第1~第3の分岐管80,82,84の各内部空間によって、第1~第3の分岐開口部86,88,90と接続する内部流路がそれぞれ形成されている。また、第1の分岐管80と第2の分岐管82は、本体部78の外周上の対向する位置に形成されて、略同一軸上に配置されている。一方、第3の分岐管84は、本体部78の外周上で、第1の分岐管80および第2の分岐管82に対して略90度の角度をなす位置に形成されている。 More specifically, the holder 74 has a hollow structure including a main body 78 having a substantially cylindrical shape and first to third three branch pipes 80, 82, 84 protruding from the outer periphery of the main body 78. It is a molded product. These first to third branch pipes 80, 82, 84 have one end in the axial direction connected to the main body 78 and communicated with the internal space of the main body 78, and the other end is shown in FIG. As indicated by a broken line in FIG. 19, the first to third branch openings 86, 88, and 90 communicate with the external space. As a result, the internal flow passages connected to the first to third branch openings 86, 88, 90 are formed by the internal spaces of the first to third branch pipes 80, 82, 84, respectively. Further, the first branch pipe 80 and the second branch pipe 82 are formed at opposing positions on the outer periphery of the main body 78 and are arranged on substantially the same axis. On the other hand, the third branch pipe 84 is formed on the outer periphery of the main body portion 78 at a position that forms an angle of approximately 90 degrees with respect to the first branch pipe 80 and the second branch pipe 82.
 なお、図18および図19に示す三方活栓72には、第1の分岐開口部86に対して、内周面に雌ねじが形成された雌ルアーキャップ92が外挿状態で着脱可能にねじ固定されている。また、第2の分岐管82には、内周面に雌ねじが形成されたロックアダプター94が、第2の分岐管82に形成された図示しないフランジ状部で抜け出し不能に係止されて外挿状態で装着されている。更に、第2の分岐開口部88には、雄ルアーキャップ96が外挿状態で着脱可能に取り付けられている。 In the three-way stopcock 72 shown in FIGS. 18 and 19, a female luer cap 92 having an internal thread formed on the inner peripheral surface is detachably fixed to the first branch opening 86 in an externally inserted state. ing. In addition, a lock adapter 94 having an internal thread formed on the inner peripheral surface of the second branch pipe 82 is engaged with a flange-like portion (not shown) formed on the second branch pipe 82 so as not to be pulled out and is extrapolated. It is installed in a state. Furthermore, a male luer cap 96 is detachably attached to the second branch opening 88 in an extrapolated state.
 かかる本体部78にコック76が挿し入れられて、回動可能で液密に組み付けられている。このコック76を回動操作することにより、第1~第3の分岐管80,82,84の内部空間によって形成されて第1~第3の分岐開口部86,88,90において開口する各内部流路を、選択的に連通させることが可能となっている。 A cock 76 is inserted into the main body 78, and is rotatable and liquid-tightly assembled. By rotating the cock 76, the internal spaces formed by the internal spaces of the first to third branch pipes 80, 82, 84 and opened at the first to third branch openings 86, 88, 90 are provided. The flow path can be selectively communicated.
 また、ホルダ74の第3の分岐管84の分岐開口部90に対して、医療用コネクタ10が接続されることで、三方活栓72が構成される。このような構造とされた三方活栓72は、一般に、第1の分岐開口部86が輸液ルートの上流側のチューブと接続され、第2の分岐開口部88が下流側のチューブと接続されることによって、第1の分岐管80と第2の分岐管82によって輸液ルートの一部を構成して輸液ルート上に配設される。 Also, the three-way stopcock 72 is configured by connecting the medical connector 10 to the branch opening 90 of the third branch pipe 84 of the holder 74. In the three-way stopcock 72 having such a structure, generally, the first branch opening 86 is connected to the tube on the upstream side of the infusion route, and the second branch opening 88 is connected to the tube on the downstream side. Thus, the first branch pipe 80 and the second branch pipe 82 constitute a part of the infusion route and are disposed on the infusion route.
 そして、医療用コネクタ10には、図20に示すように、例えば雄コネクタとしてのルアーロックコネクタ102が接続される。図20(a)はルアーロックコネクタ102の接続前の状態、図20(b)はルアーロックコネクタ102の接続状態を示す。ルアーロックコネクタ102は、例えばISO594に規定された標準的なサイズを有する従来公知のものであり、先細の円筒テーパ形状を有して外部流路を形成するルアーチップ104と、ルアーチップ104の外周を囲む雌ねじ部106を備えている。 Then, for example, a luer lock connector 102 as a male connector is connected to the medical connector 10 as shown in FIG. 20A shows a state before the luer lock connector 102 is connected, and FIG. 20B shows a connection state of the luer lock connector 102. The luer lock connector 102 is a conventionally known lure lock connector having a standard size defined in, for example, ISO 594. The luer tip 104 has a tapered cylindrical taper shape to form an external flow path, and the outer periphery of the luer tip 104. Is provided with a female thread portion 106 surrounding the.
 このルアーロックコネクタ102のルアーチップ104が医療用コネクタ10の弾性弁体14の外面40に押し当てられることで、弾性弁体14が弾性変形して、図20(b)に示すように、押し開かれたスリット50にルアーチップ104が挿通される。これにより、ルアーチップ104に接続されている例えばシリンジ等の内部空間が、ルアーチップ104内の流体流路を通じて第3の分岐管84の内部流路に連通される。それと共に、ルアーロックコネクタ102の雌ねじ部106が医療用コネクタ10の雄ねじ部30と螺合することによって、ルアーチップ104の挿通状態が確実に維持される。 When the luer tip 104 of the luer lock connector 102 is pressed against the outer surface 40 of the elastic valve body 14 of the medical connector 10, the elastic valve body 14 is elastically deformed, and as shown in FIG. The luer tip 104 is inserted into the opened slit 50. As a result, the internal space such as a syringe connected to the luer tip 104 is communicated with the internal channel of the third branch pipe 84 through the fluid channel in the luer tip 104. At the same time, the threaded portion 106 of the luer lock connector 102 is screwed into the male threaded portion 30 of the medical connector 10, so that the insertion state of the luer tip 104 is reliably maintained.
 かかるルアーチップ104の挿通状態で、コック76を操作して第3の分岐管84と第2の分岐管82を連通状態とすることによって、シリンジ内に充填された薬液を輸液ルート上に混注することが可能となる。そして、混注が完了してルアーチップ104を抜去した後は、弾性弁体14の弾性復元力によって、中央部34が円板形状に復帰して、スリット50が略気密に閉塞されることとなる。 In such a state that the luer tip 104 is inserted, the cock 76 is operated to bring the third branch pipe 84 and the second branch pipe 82 into a communication state, whereby the liquid medicine filled in the syringe is mixedly injected onto the infusion route. It becomes possible. Then, after the mixed injection is completed and the luer tip 104 is removed, the central portion 34 is restored to the disk shape by the elastic restoring force of the elastic valve body 14, and the slit 50 is closed substantially airtightly. .
 なお、図20においては、雄コネクタとして雌ねじ部106を有するルアーロックタイプのコネクタを例示しているが、雌ねじ部106を有さず、ルアーチップ104のみを備える所謂ルアースリップタイプのコネクタも、接続可能である。雄コネクタとしてルアースリップタイプのみが対象とされるような場合には、ハウジング12の段付形状や雄ねじ部30は必ずしも必要ではない。 20 illustrates a luer lock type connector having a female thread portion 106 as a male connector. However, a so-called luer slip type connector that does not have the female thread portion 106 and includes only the luer tip 104 is also connected. Is possible. When only the luer slip type is targeted as the male connector, the stepped shape of the housing 12 and the male screw portion 30 are not necessarily required.
 以上、本発明の実施形態について詳述してきたが、本発明はその具体的な記載によって限定されない。例えば、溶着凸部は、ハウジングの開口端面からリング部材に向かって突出するように設けられていても良い。更に、ハウジングとリング部材の重ね合わせ面の両方から突出するように、ハウジングとリング部材にそれぞれ溶着凸部を形成することもできる。 As mentioned above, although embodiment of this invention has been explained in full detail, this invention is not limited by the specific description. For example, the welding convex portion may be provided so as to protrude from the opening end surface of the housing toward the ring member. Furthermore, it is also possible to form welding convex portions on the housing and the ring member so as to protrude from both the overlapping surfaces of the housing and the ring member.
 また、前記実施形態のように、溶着凸部がハウジングとリング部材の重ね合わせ面において径方向で部分的に形成される場合には、溶着凸部が重ね合わせ面の径方向中間部分に設けられることが望ましいが、例えば重ね合わせ面の内周端や外周端に設けることも可能である。更に、複数の溶着凸部が径方向で相互に離れて配置されていても良い。 Further, when the welding convex portion is partially formed in the radial direction on the overlapping surface of the housing and the ring member as in the above-described embodiment, the welding convex portion is provided in the radial intermediate portion of the overlapping surface. Although it is desirable, for example, it can be provided at the inner peripheral end or the outer peripheral end of the overlapping surface. Furthermore, a plurality of welding projections may be arranged away from each other in the radial direction.
 さらに、ハウジングとリング部材の重ね合わせ面の径方向中間部分に溶着部が設けられている場合には、前記実施形態にも示したように、溶着部を外れた内周側と外周側の何れか一方にのみ位置決め部を設けても良いし、内周側と外周側の両方に位置決め部を設けることで、当接による位置決め作用をより高度に得ることも可能である。 Further, when a welded portion is provided at the radial intermediate portion of the overlapping surface of the housing and the ring member, as shown in the above embodiment, either the inner peripheral side or the outer peripheral side outside the welded portion is used. Positioning portions may be provided only on one of them, or by providing positioning portions on both the inner peripheral side and the outer peripheral side, it is possible to obtain a higher positioning action by contact.
 更にまた、重ね合わせ面の径方向中間部分に溶着部が設けられて、径方向で外れた位置に位置決め部が設けられる場合には、位置決め部は溶着部と隣接して設けられることが望ましいが、溶融樹脂のはみ出しを防止するための溝を溶着凸部に沿って設けるなどして、溶着部と位置決め部を径方向に離れて配することもできる。 Furthermore, when the welding portion is provided in the intermediate portion in the radial direction of the overlapping surface and the positioning portion is provided at a position deviated in the radial direction, the positioning portion is preferably provided adjacent to the welding portion. Further, the welded portion and the positioning portion can be spaced apart from each other in the radial direction by providing a groove for preventing the molten resin from protruding along the welded convex portion.
 また、溶着凸部は、ハウジングとリング部材の重ね合わせ面において周方向の全周に亘って連続する環状には限定されず、例えば、それぞれ突起状とされた複数の溶着凸部が、周方向で相互に離れて断続的に設けられていても良い。 Further, the welding convex portion is not limited to an annular shape that is continuous over the entire circumference in the circumferential direction on the overlapping surface of the housing and the ring member. For example, a plurality of welding convex portions each having a protruding shape are provided in the circumferential direction. And may be provided intermittently apart from each other.
 さらに、溶着凸部がハウジングとリング部材の重ね合わせ面において周上で部分的に形成される場合には、溶着凸部が重ね合わせ面の径方向全長に亘って連続して設けられていても良い。この場合には、複数の溶着凸部の周方向間でハウジングとリング部材が軸方向に当接して、ハウジングとリング部材が軸方向で相互に位置決めされる。 Furthermore, when the welding convex part is partially formed on the circumference on the overlapping surface of the housing and the ring member, the welding convex part may be provided continuously over the entire radial direction of the overlapping surface. good. In this case, the housing and the ring member abut on each other in the axial direction between the circumferential directions of the plurality of welding projections, and the housing and the ring member are positioned relative to each other in the axial direction.
 また、前記実施形態においてリング部材52の内周挟持部54に設けられる嵌合凸部58と環状凸部60は必須ではない。即ち、リング部材における内周挟持部の下面の形状は、弾性弁体の形状などによって適宜に変更され得るものであって、例えば下面が平坦面とされたリング部材の内周挟持部も採用され得る。また、嵌合凸部は、全周に亘って連続していることが望ましいが、ハウジングの開口部に挿し入れられる形状とされていれば、必ずしも全周に亘って連続して設けられている必要はない。具体的には、嵌合凸部は、周方向で複数に分割された構造であっても良い。 In the above-described embodiment, the fitting convex portion 58 and the annular convex portion 60 provided on the inner peripheral clamping portion 54 of the ring member 52 are not essential. That is, the shape of the lower surface of the inner peripheral clamping portion in the ring member can be changed as appropriate depending on the shape of the elastic valve body, and for example, the inner peripheral clamping portion of the ring member having a flat lower surface is also employed. obtain. Moreover, although it is desirable that the fitting convex part is continuous over the entire circumference, the fitting convex part is not necessarily provided continuously over the entire circumference as long as it is configured to be inserted into the opening of the housing. There is no need. Specifically, the fitting convex portion may have a structure divided into a plurality in the circumferential direction.
 また、前記実施形態においては、本発明に係る医療用コネクタ10を三方活栓の混注ポートとして用いる例を示したが、例えば、図21(a),(b),(c)に示されるように、混注プラグ108や、混注管112や、薬剤バッグ118等を構成する医療用コネクタに本発明を適用することも勿論可能である。 Moreover, in the said embodiment, although the example which uses the medical connector 10 which concerns on this invention as a mixed injection port of a three-way cock was shown, as shown to Fig.21 (a), (b), (c), for example. Of course, the present invention can be applied to the medical connector constituting the mixed injection plug 108, the mixed injection tube 112, the drug bag 118, and the like.
 より詳細には、図21(a)に示される混注プラグ108では、前記実施形態の医療用コネクタ10のハウジング12に対して、筒状のプラグ本体110の一方の開口部が液密に取り付けられており、これら医療用コネクタ10とプラグ本体110とにより混注プラグ108が構成されている。また、図21(b)に示される混注管112では、長尺の輸液管体114に対して筒状の取付部116が上方に開口して設けられており、この取付部116の開口部に対して、前記実施形態の医療用コネクタ10のハウジング12が液密に取り付けられている。これら医療用コネクタ10と輸液管体114及び取付部116により混注管112が構成されている。さらに、図21(c)に示される薬剤バッグ118においては、医療用コネクタ10のハウジング12が筒状に伸び出すことにより、各種の薬液や生理食塩水等が封入されたバッグ本体120と接続されている。バッグ本体120はアルミニウムが蒸着された合成樹脂製のシート材等で構成されており、開口周辺部が溶着等により閉塞されて医療用コネクタ10と一体的に密封されることにより、医療用コネクタ10とバッグ本体120とが液密に連結されて接続されている。これら医療用コネクタ10とバッグ本体120とにより薬剤バッグ118が構成されている。 More specifically, in the mixed injection plug 108 shown in FIG. 21A, one opening of the cylindrical plug body 110 is liquid-tightly attached to the housing 12 of the medical connector 10 of the embodiment. The medical connector 10 and the plug main body 110 constitute a mixed injection plug 108. Further, in the mixed injection tube 112 shown in FIG. 21 (b), a cylindrical attachment portion 116 is provided to open upward with respect to the long infusion tube body 114, and the opening portion of the attachment portion 116 is provided. On the other hand, the housing 12 of the medical connector 10 of the embodiment is attached in a liquid-tight manner. The medical connector 10, the infusion tube 114 and the attachment portion 116 constitute a mixed injection tube 112. Furthermore, in the medicine bag 118 shown in FIG. 21 (c), the housing 12 of the medical connector 10 extends into a cylindrical shape, so that the medicine bag 118 is connected to the bag body 120 in which various kinds of drug solutions, physiological saline, and the like are enclosed. ing. The bag body 120 is made of a synthetic resin sheet material on which aluminum is vapor-deposited. The peripheral portion of the opening is closed by welding or the like, and is sealed integrally with the medical connector 10, whereby the medical connector 10. And the bag body 120 are connected in a liquid-tight manner. The medical connector 10 and the bag body 120 constitute a drug bag 118.
 前記実施形態では、ハウジング12の開口端面32にリング部材52が重ね合わされて、それらハウジング12とリング部材52の重ね合わせ面間が溶着されるようになっているが、溶着されるハウジング12とリング部材52の重ね合わせ面は、必ずしもハウジング12の開口端面32に限定されない。即ち、リング部材の外周部分がハウジング12の開口部20に向かって延びる筒状とされて、かかる筒状部分がハウジング12の開口部20に外挿されると共に、筒状部分の下端に設けられたフランジ部がハウジング12に重ね合わされて、該フランジ部とハウジング12の重ね合わせ面間に設けられた溶着凸部62が溶融されることにより、リング部材の筒状部分の下端がハウジング12に溶着されるようにしても良い。 In the above-described embodiment, the ring member 52 is overlapped on the opening end surface 32 of the housing 12 so that the overlapping surface of the housing 12 and the ring member 52 is welded. The overlapping surface of the member 52 is not necessarily limited to the opening end surface 32 of the housing 12. That is, the outer peripheral portion of the ring member has a cylindrical shape extending toward the opening 20 of the housing 12, and the cylindrical portion is extrapolated to the opening 20 of the housing 12 and provided at the lower end of the cylindrical portion. The flange portion is overlapped with the housing 12, and the welding convex portion 62 provided between the overlapping surfaces of the flange portion and the housing 12 is melted, so that the lower end of the cylindrical portion of the ring member is welded to the housing 12. You may make it.
 また、例えば、弁体セット工程を、弾性弁体14の外環状凹溝44にリング部材52の環状凸部60を差し入れるなどして、弾性弁体14をリング部材52にセットする工程とすることもできる。この場合には、例えば溶融工程が、弾性弁体14がセットされたリング部材52の下面を、ハウジング12の開口端面32に重ね合わせて、リング部材52の溶着凸部62を溶融させる工程とされる。 Further, for example, the valve body setting step is a step of setting the elastic valve body 14 to the ring member 52 by inserting the annular convex portion 60 of the ring member 52 into the outer annular groove 44 of the elastic valve body 14. You can also. In this case, for example, the melting step is a step of superimposing the lower surface of the ring member 52 on which the elastic valve body 14 is set on the opening end surface 32 of the housing 12 to melt the welding convex portion 62 of the ring member 52. The
 その他、一々列挙はしないが、本発明は、当業者の知識に基づいて種々なる変更,修正,改良等を加えた態様において実施され得るものであり、また、そのような実施態様が、本発明の趣旨を逸脱しない限り、何れも、本発明の範囲内に含まれるものであることは、言うまでもない。 In addition, although not enumerated one by one, the present invention can be carried out in a mode to which various changes, modifications, improvements and the like are added based on the knowledge of those skilled in the art. It goes without saying that all are included in the scope of the present invention without departing from the spirit of the present invention.
10:医療用コネクタ、12:ハウジング、14:弾性弁体、20:開口部、22:弁受座、24:係止凸部(環状凸部)、32:開口端面、42:内環状凹溝(環状凹溝)、44:外環状凹溝(環状凹溝)、52:リング部材、58:嵌合凸部、60:環状凸部、62:溶着凸部、64:当接面、66:溶着部、68:位置決め部 DESCRIPTION OF SYMBOLS 10: Medical connector, 12: Housing, 14: Elastic valve body, 20: Opening part, 22: Valve seat, 24: Locking convex part (annular convex part), 32: Opening end surface, 42: Inner annular concave groove (Annular groove), 44: outer annular groove (annular groove), 52: ring member, 58: fitting convex part, 60: annular convex part, 62: welding convex part, 64: contact surface, 66: Welding part, 68: Positioning part

Claims (10)

  1.  ディスク状の弾性弁体の外周部分を支持する弁受座が形成された開口部を備えた熱可塑性樹脂製のハウジングを準備するハウジング準備工程と、
     該ハウジングの前記開口部に取り付けられて前記弾性弁体の外周部分を前記弁受座との間で挟持する熱可塑性樹脂製のリング部材を準備するリング部材準備工程と、
     前記弾性弁体を前記ハウジングの前記弁受座で支持させて前記開口部にセットする弁体セット工程と、
     前記弾性弁体がセットされた前記ハウジングに前記リング部材を重ね合わせて、それらハウジングとリング部材の重ね合わせ面に突設した溶着凸部を溶融させる溶融工程と、
     該溶融工程における前記溶着凸部の溶融状態下で、該溶着凸部が潰れて前記ハウジングと前記リング部材の重ね合わせ面の当接面積が増大するまで該ハウジングと該リング部材を接近方向へ押圧してそれらハウジングとリング部材を該溶着凸部で一体的に連結固着することにより、該ハウンジングの前記弁受座と該リング部材で前記弾性弁体の外周部分を挟持させる弁体固定工程と
    を、有することを特徴とする医療用コネクタの製造方法。
    A housing preparation step of preparing a housing made of a thermoplastic resin having an opening in which a valve seat for supporting an outer peripheral portion of a disc-shaped elastic valve body is formed;
    A ring member preparing step of preparing a ring member made of a thermoplastic resin attached to the opening of the housing and sandwiching an outer peripheral portion of the elastic valve body with the valve seat;
    A valve body setting step of setting the elastic valve body at the opening by supporting the elastic valve body at the valve seat of the housing;
    A melting step of superimposing the ring member on the housing in which the elastic valve body is set, and melting a welding convex portion protruding from an overlapping surface of the housing and the ring member;
    Under the molten state of the welding projection in the melting step, the housing and the ring member are pressed in the approaching direction until the welding projection is crushed and the contact area of the overlapping surface of the housing and the ring member increases. Then, the housing and the ring member are integrally connected and fixed by the welding convex portion, and thereby the valve seat for the housing and the valve body fixing step for holding the outer peripheral portion of the elastic valve body by the ring member. A method of manufacturing a medical connector, comprising:
  2.  前記ハウジングと前記リング部材の重ね合わせ面において、重ね合わせ面から先端部までの長さが均一に形成された前記溶着凸部を全周に亘って連続的にして或いは周方向に断続的に設けた請求項1に記載の医療用コネクタの製造方法。 In the overlapping surface of the housing and the ring member, the welding convex portion having a uniform length from the overlapping surface to the tip is provided continuously or intermittently in the circumferential direction. The manufacturing method of the medical connector of Claim 1.
  3.  前記弾性弁体として、外周部分の内外両面にそれぞれ開口して周方向に延びる環状凹溝が設けられた構造を採用する一方、
     前記ハウジングとして、該弾性弁体の内面に設けられた該環状凹溝に差し入れられる環状凸部が設けられた前記弁受座の構造を採用すると共に、
     前記リング部材として、該弾性弁体の外面に設けられた該環状凹溝に差し入れられる環状凸部が設けられた構造を採用し、
     前記弁体セット工程において、該弾性弁体の内面の該環状凹溝に対して該ハウジングの該弁受座の該環状凸部を差し入れてセットして、前記溶融工程および前記弁体固定工程において、該弾性弁体の外面の該環状凹溝に対して該リング部材の該環状凸部を差し入れることにより、該弾性弁体の内外面の各該環状凹溝に対して各該環状凸部を押し入れて嵌め合わせる請求項1又は2に記載の医療用コネクタの製造方法。
    As the elastic valve body, while adopting a structure provided with annular concave grooves that open in the inner and outer surfaces of the outer peripheral portion and extend in the circumferential direction,
    As the housing, adopting the structure of the valve seat provided with an annular convex portion inserted into the annular concave groove provided on the inner surface of the elastic valve body,
    As the ring member, adopting a structure provided with an annular convex portion inserted into the annular concave groove provided on the outer surface of the elastic valve body,
    In the valve body setting step, the annular convex portion of the valve seat of the housing is inserted into the annular concave groove on the inner surface of the elastic valve body and set, and in the melting step and the valve body fixing step The annular projections are inserted into the annular grooves on the inner and outer surfaces of the elastic valve body by inserting the annular projections of the ring member into the annular grooves on the outer surface of the elastic valve body. The manufacturing method of the medical connector of Claim 1 or 2 which pushes and fits.
  4.  前記溶融工程において、前記ハウジングと前記リング部材の重ね合わせ面における前記溶着凸部の当接部に対して超音波振動をおよぼして溶融させる請求項1~3の何れか1項に記載の医療用コネクタの製造方法。 The medical use according to any one of claims 1 to 3, wherein in the melting step, the contact portion of the welding convex portion on the overlapping surface of the housing and the ring member is melted by applying ultrasonic vibration. A method for manufacturing a connector.
  5.  前記リング部材として、前記ハウジングの前記開口部に挿し入れられて該ハウジングの該開口部の内周面に対して径方向に位置決めされる嵌合凸部を設けた構造を採用し、
     前記溶融工程および前記弁体固定工程において、該リング部材の該嵌合凸部を該ハウジングの該開口部に挿し入れた状態で前記溶着凸部を溶融させる請求項1~4の何れか1項に記載の医療用コネクタの製造方法。
    As the ring member, adopting a structure provided with a fitting convex portion that is inserted into the opening of the housing and positioned in the radial direction with respect to the inner peripheral surface of the opening of the housing,
    5. The welding projection according to claim 1, wherein, in the melting step and the valve body fixing step, the welding projection is melted in a state where the fitting projection of the ring member is inserted into the opening of the housing. A method for producing the medical connector according to 1.
  6.  ハウジングの開口部に対してディスク状の弾性弁体が組み付けられて、該弾性弁体の外周部分が該ハウジングで支持されている医療用コネクタであって、
     前記ハウジングの前記開口部において前記弾性弁体の外周部分の内面を支持する弁受座が形成されていると共に、該弾性弁体の外周部分の外面にリング部材が重ね合わされて、該弾性弁体の周囲において該ハウジングと該リング部材とが直接に固着されることにより該弁受座と該リング部材との間で該弾性弁体の外周部分が挟持されており、
     該ハウジングと該リング部材との固着部分では、それらハウジングとリング部材の重ね合わせ面間に突設された溶着凸部が溶融されて溶着部が設けられていると共に、該重ね合わせ面間における該溶着凸部を外れた部分が相互に当接して該ハウジングと該リング部材を接近方向で位置決めする位置決め部が設けられていることを特徴とする医療用コネクタ。
    A medical connector in which a disc-shaped elastic valve body is assembled to an opening of a housing, and an outer peripheral portion of the elastic valve body is supported by the housing,
    A valve seat for supporting the inner surface of the outer peripheral portion of the elastic valve body is formed in the opening of the housing, and a ring member is superimposed on the outer surface of the outer peripheral portion of the elastic valve body, and the elastic valve body The outer peripheral portion of the elastic valve body is sandwiched between the valve seat and the ring member by directly fixing the housing and the ring member around
    In the fixing portion between the housing and the ring member, a welding convex portion provided between the overlapping surfaces of the housing and the ring member is melted to provide a welding portion, and the bonding portion between the overlapping surfaces is provided. A medical connector comprising a positioning portion for positioning the housing and the ring member in an approaching direction by contacting portions of the welding convex portion with each other and contacting each other.
  7.  前記リング部材には、前記ハウジングと係合し、該ハウジングと前記リング部材とが重ね合わされてから溶着凸部が溶融し、重ね合わせ面間における該溶着凸部を外れた部分が相互に当接するまでの前記ハウジングの移動をガイドするガイド部が形成されている請求項6に記載の医療用コネクタ。 The ring member engages with the housing, and the welding convex portion melts after the housing and the ring member are overlapped with each other, and the portions where the welding convex portion is removed between the overlapping surfaces contact each other. The medical connector according to claim 6, wherein a guide portion for guiding the movement of the housing up to is formed.
  8.  前記溶着部が前記ハウジングの周方向で全周に亘って連続して形成されていると共に、該溶着部を径方向に外れた位置に前記位置決め部が設けられている請求項6又は7に記載の医療用コネクタ。 The said welding part is continuously formed over the perimeter in the circumferential direction of the said housing, and the said positioning part is provided in the position which remove | deviated this welding part in radial direction. Medical connector.
  9.  前記リング部材において、前記ハウジングの前記開口部に挿し入れられて該ハウジングの該開口部の内周面に対して径方向に位置決めされる嵌合凸部が設けられている請求項6~8の何れか1項に記載の医療用コネクタ。 9. The ring member according to claim 6, further comprising a fitting protrusion that is inserted into the opening of the housing and positioned in a radial direction with respect to an inner peripheral surface of the opening of the housing. The medical connector according to any one of the above.
  10.  ディスク状の弾性弁体の外周部分を支持する弁受座が形成された開口部を備えた熱可塑性樹脂製のハウジングを準備するハウジング準備工程と、
     該ハウジングの前記開口部に取り付けられて前記弾性弁体の外周部分を前記弁受座との間で挟持する熱可塑性樹脂製のリング部材を準備するリング部材準備工程と、
     前記弾性弁体を前記リング部材にセットする弁体セット工程と、
     前記弾性弁体がセットされた前記リング部材に前記ハウジングを重ね合わせて、それらハウジングとリング部材の重ね合わせ面に突設した溶着凸部を溶融させる溶融工程と、
     該溶融工程における前記溶着凸部の溶融状態下で、該溶着凸部が潰れて前記ハウジングと前記リング部材の重ね合わせ面の当接面積が増大するまで該ハウジングと該リング部材を接近方向へ押圧してそれらハウジングとリング部材を該溶着凸部で一体的に連結固着することにより、該ハウンジングの前記弁受座と該リング部材で前記弾性弁体の外周部分を挟持させる弁体固定工程と
    を、有することを特徴とする医療用コネクタの製造方法。
    A housing preparation step of preparing a housing made of a thermoplastic resin having an opening in which a valve seat for supporting an outer peripheral portion of a disc-shaped elastic valve body is formed;
    A ring member preparing step of preparing a ring member made of a thermoplastic resin attached to the opening of the housing and sandwiching an outer peripheral portion of the elastic valve body with the valve seat;
    A valve body setting step for setting the elastic valve body on the ring member;
    A melting step of superimposing the housing on the ring member on which the elastic valve body is set, and melting a welding convex portion protruding from the overlapping surface of the housing and the ring member;
    Under the molten state of the welding projection in the melting step, the housing and the ring member are pressed in the approaching direction until the welding projection is crushed and the contact area of the overlapping surface of the housing and the ring member increases. Then, the housing and the ring member are integrally connected and fixed by the welding convex portion, and thereby the valve seat for the housing and the valve body fixing step for holding the outer peripheral portion of the elastic valve body by the ring member. A method of manufacturing a medical connector, comprising:
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