WO2014046271A1 - Connecteur médical et son procédé de fabrication - Google Patents

Connecteur médical et son procédé de fabrication Download PDF

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Publication number
WO2014046271A1
WO2014046271A1 PCT/JP2013/075590 JP2013075590W WO2014046271A1 WO 2014046271 A1 WO2014046271 A1 WO 2014046271A1 JP 2013075590 W JP2013075590 W JP 2013075590W WO 2014046271 A1 WO2014046271 A1 WO 2014046271A1
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WO
WIPO (PCT)
Prior art keywords
valve body
elastic valve
slit
medical connector
outer peripheral
Prior art date
Application number
PCT/JP2013/075590
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English (en)
Japanese (ja)
Inventor
裕之 中神
辰也 工藤
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 JP2014536950A priority Critical patent/JP6678390B2/ja
Publication of WO2014046271A1 publication Critical patent/WO2014046271A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/229—Stopcocks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A61M2039/2426—Slit valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the present invention relates to a medical connector that is used in a fluid flow path in the medical field such as an infusion route and that can connect a medical connector (male connector) such as a syringe to the fluid flow path, and a manufacturing method thereof. It is.
  • a medical connector In a fluid flow path such as an infusion route for infusion and blood collection in the medical field, a medical connector is used to enable connection of a male connector such as a syringe as necessary.
  • a male connector such as a syringe
  • a fluid channel is formed between a pair of channel openings, and a medical connector is attached to the remaining one channel opening.
  • a split septum type medical connector described in JP-T-2-502976 (Patent Document 1) or the like is known as one type of such a medical connector.
  • This medical connector has a structure in which a disk-like elastic valve body having a slit formed in a central portion is mounted on a cylindrical housing constituting an opening portion of a fluid flow path.
  • the male connector can be connected to the fluid flow path in a communicating state by directly inserting the tip of the male connector into the slit of the elastic valve element. Further, by pulling out the distal end portion of the male connector such as a syringe thus connected from the elastic valve body, the fluid flow path is held in a shut-off state by the restoring action of the elastic valve body simultaneously with the extraction. .
  • the slit formed in the elastic valve body has a single-letter shape extending linearly in the radial direction for ease of formation and the like, and the male connector is inserted into the slit while expanding the slit in the width direction.
  • the male connector is connected to the fluid flow path in a communicating state.
  • the present invention has been made in the background of the above-mentioned circumstances, and its solution is a medical valve having a novel structure capable of preventing the elastic valve body from falling off the housing, and a method for manufacturing the same. Is to provide.
  • the first aspect of the present invention is a medical device in which a disc-shaped elastic valve body having a slit formed in a cylindrical housing is disposed and the outer peripheral portion of the elastic valve body is supported by the housing.
  • the elastic connector is characterized in that the slit of the elastic valve body is composed of three or more cuts extending radially from the central portion of the elastic valve body toward the outer peripheral side.
  • the slit when the male connector is inserted into the slit, the slit is configured by three or more incisions extending radially, thereby being easily opened.
  • the frictional resistance acting between the male connector and the inner surface of the slit is reduced.
  • the length of the cut in the inner surface of the elastic valve body is larger than the length of the cut in the outer surface of the elastic valve body. It is what has become.
  • the switching (opening) of the slit to the communication state is prevented until a higher pressure is exerted on the inner surface of the elastic valve body. To prevent leakage.
  • the entire cut forming the slit is inserted into the slit on the outer surface of the elastic valve body. It is provided within a range that fits within the tip of the male lure.
  • the elastic valve element can be brought into close contact with the male luer when the male luer is inserted.
  • liquid-tightness can be ensured more stably.
  • annular grooves extending in the circumferential direction are formed on both the inner and outer surfaces of the outer peripheral portion of the elastic valve body.
  • annular constricted portion is provided, and the outer peripheral side of the elastic valve body is an annular fixed portion, while the valve seat projects from the inner peripheral side of the housing.
  • the housing is provided with an opening locking piece, and locking projections are formed on the valve seat and the inner peripheral edge of the opening locking piece, respectively.
  • the elastic valve body is engaged with the annular grooves formed on both the inner and outer surfaces.
  • the locking protrusions provided on the housing are respectively inserted and locked into the annular grooves formed on both the inner and outer surfaces of the elastic valve body, so that the outer peripheral portion of the elastic valve body is The formed annular fixing portion restricts displacement toward the inner peripheral side by the locking projection. This prevents the elastic valve body from falling off the housing due to elastic deformation when the male connector is connected, and the elastic valve body is stably held in a predetermined mounting state with respect to the housing.
  • the slit is configured by three or more cuts, and the force acting on the elastic valve body is reduced by the connection of the male connector, in addition to the support structure for the elastic valve body shown in this embodiment. By adopting it, it becomes possible to more effectively prevent the elastic valve body from coming off from the housing.
  • a portion where the slit is formed in the elastic valve body has a flat plate shape.
  • the deformation mode of the elastic valve body is stabilized and the penetration length of the slit is made substantially constant over the whole, the switching condition between the communication of each notch and the cutoff is substantially uniform. Is done. Therefore, partial communication or the like of the slit due to irregular deformation is prevented, and liquid leakage through the slit due to the action of liquid pressure from the fluid flow path side is prevented more stably.
  • the three slits provided so that the slits are equiangular in the circumferential direction. It is comprised and the radial direction dimension of each notch is made substantially equal.
  • each notch is formed equiangularly from the central portion of the elastic valve body toward the outer peripheral side and having substantially the same radial dimension, the inner surface of the slit is connected when the male connector is connected. Are not easily opened due to being hooked with each other, or the opening edges of the slits are hooked with each other when the male connector is pulled out, thereby preventing problems such as failure to return to the initial shut-off state.
  • a medical device in which a disk-shaped elastic valve body having a slit formed in a cylindrical housing is disposed, and an outer peripheral portion of the elastic valve body is supported by the housing.
  • a method of manufacturing a connector for an automobile, wherein the slit formed by three or more cuts extending radially by pressing a cutting blade of a cutter against the molded elastic valve body from the inner surface side is provided in the elastic valve body. It has the process of forming later.
  • the elastic deformation of the elastic valve body due to the pressing of the cutter is used, or a cutter having a cross-sectional shape that contracts toward the distal end side is used.
  • a cutter having a cross-sectional shape that contracts toward the distal end side is used.
  • the slit formed in the elastic valve body is constituted by three or more cuts extending radially from the central portion toward the outer peripheral side, and the opening edge of the slit is elastically deformed when the male connector is connected.
  • the frictional resistance acting between the outer peripheral surface of the male connector and the inner surface of the slit is reduced. Therefore, when the male connector is connected, the force acting on the elastic valve body is reduced, and the elastic valve body is stably held in a predetermined mounting state without dropping from the housing.
  • FIG. 4 is a cross-sectional view of the co-injection port shown in FIG. 3, corresponding to the IV-IV cross section of FIG. 6.
  • FIG. 4 is an exploded perspective view of the mixed injection port shown in FIG. 3.
  • FIG. 6 is a cross-sectional model diagram illustrating a process of forming a slit in the elastic valve body shown in FIG. 8, wherein (a) shows a set state on the jig before the cutter is cut into the elastic valve body; Shows a state in which the cutter is cut into the elastic valve body, and (c) shows a state after slit formation in which the cutter is extracted from the elastic valve body.
  • surface which shows the actual measurement result of the maximum pressure in the elastic valve body shown by FIG. The top view of the elastic valve body which comprises the medical connector as another embodiment of this invention. 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 T-shaped mixed injection pipe, respectively.
  • FIG. 1 and FIG. 2 show a three-way cock 10 provided with a medical connector as one embodiment of the present invention.
  • the three-way stopcock 10 has a structure in which a cock 14 is attached to a holder 12.
  • the vertical direction means the vertical direction in FIG. 2 unless otherwise specified.
  • the holder 12 is an integrally formed product having a hollow structure including a main body 16 having a substantially cylindrical shape and first to third three branch pipes 18, 20, 22 projecting from the outer periphery of the main body 16. Yes.
  • Each of the first to third branch pipes 18, 20, and 22 has a cylindrical shape with both ends in the axial direction opened, and one end in the axial direction is connected to the main body portion 16 so that the inside of the main body portion 16
  • the first and third branch openings 24, 26, and 28 communicated with the external space, which are communicated with the space, and whose other end portions are modeled by dotted lines in FIG. 2.
  • the internal flow paths connecting the first to third branch openings 24, 26, and 28 and the main body 16 are formed by the internal spaces of the first to third branch pipes 18, 20, and 22, respectively.
  • the first branch pipe 18 and the second branch pipe 20 are formed at opposing positions on the outer periphery of the main body portion 16 and are arranged on substantially the same axis.
  • the third branch pipe 22 is formed on the outer periphery of the main body portion 16 at a position that forms an angle of approximately 90 degrees with respect to the first branch pipe 18 and the second branch pipe 20.
  • a female luer cap 30 having an internal thread formed on the inner peripheral surface thereof is detachably fixed to the first branch opening 24 in an extrapolated state.
  • a lock adapter 32 having an internal thread formed on the inner peripheral surface of the second branch pipe 20 is locked by a flange-like portion (not shown) formed on the second branch pipe 20 so that it cannot be pulled out. It is installed in a state.
  • a male luer cap 34 is detachably attached to the second branch opening 26 in an extrapolated state.
  • the cock 14 is inserted into the main body 16 so as to be rotatable and liquid-tightly assembled.
  • the internal spaces formed by the internal spaces of the first to third branch pipes 18, 20, and 22 are opened at the first to third branch openings 24, 26, and 28.
  • the flow path can be selectively communicated.
  • the third branch opening 28 is provided with a mixed injection port 36 as a medical connector.
  • 3 and 4 show the detailed structure of the mixed injection port 36.
  • the mixed injection port 36 has a structure in which an elastic valve body 40 having a disk shape is attached to a central hole of a cylindrical mouth body 38 as a cylindrical housing.
  • the cylindrical mouth body 38 has a stepped cylindrical shape in which a large diameter cylindrical portion 46 and a small diameter cylindrical portion 48 are integrally formed.
  • the inner diameter dimension of the small-diameter cylindrical portion 48 is set to a size that can accommodate the elastic valve body 40 at least on the opening 50 side (upper side in FIG. 4), and the re-sealed state of the slit 92 (described later) after the male connector is removed is stable.
  • the outer diameter of the elastic valve element 40 is preferably substantially equal to the outer diameter.
  • the cylindrical mouth body 38 is preferably formed of a material having a strength capable of reliably holding the elastic valve body 40, and specifically, polypropylene, polyethylene, polyvinyl chloride, polycarbonate, polystyrene, polyacetal, and the like. A thermoplastic resin is illustrated.
  • the cylindrical mouth body 38 is molded from these materials by injection molding or the like.
  • the small-diameter cylindrical portion 48 is integrally formed with an annular protrusion 54 as a valve seat that protrudes inward in the radial direction.
  • a locking projection 56 that projects outward (upward in FIG. 4) is integrally formed.
  • the locking projection 56 has a peripheral wall shape that is continuous over the entire circumference with a certain protruding height dimension, and an annular fitting groove 58 is formed by the annular projection 54 and the locking projection 56.
  • the cylindrical mouth body 38 opens toward the opening on the small diameter cylindrical portion 48 side.
  • a portion extending from the inner peripheral surface of the locking projection 56 to the inner peripheral surface of the annular protrusion 54 is a contact inner peripheral surface 60 that extends over the entire circumference in the circumferential direction with a curved convex shape.
  • the inner surface of the peripheral wall located axially inward from the projecting portion of the locking projection 56 is a cylindrical surface 62 that extends linearly inward in the axial direction with a substantially constant inner diameter dimension.
  • a male screw portion 64 into which a female screw portion 114 of a luer lock connector 110 which is a kind of male luer described later is screwed is formed.
  • the male threaded portion 64 is preferably the female threaded portion of the luer lock connector 110 stipulated by ISO 594 and having a thread crest diameter of 7.0 ⁇ 0.2 mm and a thread root diameter of 8.0 ⁇ 0.1 mm.
  • 114 is a double thread that can be connected to 114.
  • the outer diameter of the cylindrical mouth 38 has a small diameter when the male threaded portion 64 is not formed as in the present embodiment in order to enable connection of the standard luer tip 112 defined by ISO594.
  • the outer diameter of the cylindrical portion 48 is preferably set within a range of 6.0 to 7.0 mm.
  • the small-diameter cylindrical portion 48 including a screw thread is formed. Is preferably set within a range of 7.0 to 8.0 mm.
  • an opening locking piece 65 protruding toward the inner peripheral side is continuously formed over the entire periphery at the opening edge of the cylindrical mouth body 38 on the small diameter cylindrical portion 48 side.
  • the opening locking piece 65 has a substantially annular shape with a through-hole 66 formed in the center, and the inner diameter dimension thereof is substantially equal to the diameter dimension of the central portion 76 (described later) of the elastic valve body 40.
  • the opening locking piece 65 is a flat surface in which the upper end surface 68 and the lower end surface 70 each extend in the direction perpendicular to the axis, and a locking projection 74 protruding downward is formed on the inner peripheral end of the lower end surface 70. Is formed.
  • the opening locking piece 65 is disposed so as to face upward with respect to the annular protrusion 54 and the locking protrusion 56, and the annular protrusion 54 and the locking protrusion 56 are opposed to the opening locking piece 65.
  • An elastic valve element 40 is sandwiched between them.
  • the elastic valve body 40 includes a disc-shaped central portion 76 having a substantially constant thickness dimension, and a substantially circular shape that surrounds the outer periphery of the central portion 76 over the entire circumference.
  • An annular fixing portion 78 having an annular shape is integrally formed and has a substantially disk shape as a whole.
  • the elastic valve body 40 is formed of an elastic material, and is selected from synthetic rubber such as isoprene rubber and silicone rubber, natural rubber, thermoplastic elastomer, etc. in consideration of airtightness and resealability. Is formed by press molding or molding.
  • the annular fixing part 78 extends continuously in the circumferential direction with a certain substantially rectangular cross-sectional shape.
  • the rectangular cross section has a larger axial dimension (vertical dimension in FIG. 4) than a radial dimension (horizontal dimension in FIG. 4).
  • the axial dimension of the annular fixing portion 78 is smaller than the axial dimension of the central portion 76, and the axial upper end surface of the annular fixing portion 78 is inward of the axial upper end surface of the central portion 76 (see FIG. (Lower part of 4).
  • annular grooves 84 and 86 having a concave cross section and continuously extending over the entire circumference are formed in the outer peripheral portions of the inner surface 80 and the outer surface 82 of the elastic valve body 40, respectively.
  • the annular grooves 84 and 86 are formed at substantially the same position in the radial direction of the elastic valve body 40.
  • the elastic valve body 40 has an annular constriction whose thickness is reduced by the annular grooves 84 and 86.
  • a shaped portion 88 is formed. Therefore, the elastic valve body 40 in the present embodiment is an integrally molded product in which the central portion 76 constituting the inner peripheral portion and the annular fixing portion 78 constituting the outer peripheral portion are connected by the constricted portion 88.
  • constricted portion 88 is formed at a position slightly closer to the inner surface 80 in the thickness direction of the elastic valve body 40, and the central portion 76 of the elastic valve body 40 has an inner surface 80 on the outer surface 82 side than the constricted portion 88. It is thicker than the side.
  • a concave groove 90 extending continuously over the entire circumference is formed inside the annular groove 84 on the inner surface 80.
  • the inner peripheral wall surface of the annular groove 84 is constituted by the concave groove portion 90.
  • the concave groove 90 has a curved concave shape with a constant cross-sectional shape and extends over the entire circumference in the circumferential direction, and opens toward the inner side in the axial direction of the elastic valve body 40 (downward in FIG. 4). Yes.
  • the diameter of the central portion 76 of the elastic valve body 40 is preferably set within a range of 5.0 to 6.5 mm. If the diameter of the central portion 76 of the elastic valve body 40 is smaller than 5.0 mm, it becomes difficult to insert the luer tip 112 which is the tip of the standard luer lock connector 110 whose outer diameter is unified to approximately 4.0 mm. On the other hand, if the diameter is larger than 6.5 mm, the outer diameter of the third branch opening 28 becomes large, and it becomes difficult to connect to the female threaded portion 114 of the standard luer lock connector 110.
  • the thickness dimension of the central portion 76 of the elastic valve body 40 is preferably set within a range of 1.0 to 3.0 mm. If the thickness dimension of the central portion 76 is smaller than 1.0 mm, the sealing performance at the time of insertion of the male connector such as the 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 92 is formed in the central portion 76 of the elastic valve body 40.
  • the slit 92 penetrates the central portion 76 in the axial direction and is constituted by a plurality of cuts 94 extending substantially linearly in the radial direction.
  • the cuts 94a to 94c extend radially from the radial center of the central portion 76 toward the outer peripheral side.
  • the three cuts 94a, 94b, and 94c are equally formed so as to form an equiangular shape in the circumferential direction. Is provided.
  • each of the cuts 94a to 94c constituting the slit 92 is formed with a length that does not reach the outer peripheral end of the central portion 76, and passes through the central portion 76 having a substantially constant thickness.
  • Axial dimension: L is substantially constant throughout.
  • each of the cuts 94a to 94c is in a cut-off state in which the inner surfaces in the width direction are in close contact with each other based on the elasticity of the elastic valve body 40 in a state where the elastic valve body 40 is mounted on a cylindrical mouth body 38, which will be described later. Airtightness is ensured.
  • a concave groove 90 is formed on the inner surface 80 side between the circumferential directions of the cuts 94a to 94c, the insertion resistance of the luer tip 112 when the luer lock connector 110 described later is connected can be reduced. Can do.
  • each of the cuts 94a to 94c constituting the slit 92 extends to the outer peripheral side as it goes to the inner surface 80 side, and the length in the radial direction is increased.
  • the radial dimension: L 1 of the inner surface 80 opening of the notch 94 is larger than the radial dimension: L 2 of the outer surface 82 opening of the notch 94 (L 1 > L 2 ).
  • the outer peripheral end portions of the cuts 94a to 94c are inclined with respect to the axial direction, and are further separated from the inner peripheral end portion of the cut 94 toward the inner surface 80 side. .
  • the radial dimension L 2 on the outer surface 82 side of each of the cuts 94a to 94c is provided in a range that can be accommodated in the luer tip 112 of the luer lock connector 110.
  • the elastic valve body 40 having the slit 92 composed of the three cuts 94a to 94c is formed as follows, for example. That is, first, as shown in FIGS. 8A and 9A, an elastic valve body 40 without a slit 92 is formed by vulcanization molding of a rubber elastic body or the like, and jigs 96 and 98 are formed. The inner surface 80 is set in a state of being opened upward, and the slit forming cutter 100 is positioned above the elastic valve body 40. When the elastic valve body 40 is set to the jigs 96 and 98, the outer peripheral part is sandwiched between the jigs 96 and 98, and the central part is spaced apart from the lower jig 98.
  • the cutter 100 is made to approach and displace from the inner surface 80 side with respect to the elastic valve body 40 and penetrate through the central portion 76 of the elastic valve body 40 as shown in FIG.
  • FIG. 9B pressing force caused by the cutting edge of the cutter 100 being pressed against the central portion 76, frictional force caused by inserting the cutter 100 into the central portion 76, etc.
  • the cutter 100 advances to the outer surface 82 side of the central portion 76 and penetrates while the central portion 76 is curved and deformed so as to protrude toward the outer surface 82 side.
  • the cut in the outer surface 82 of the elastic valve body 40 spreads when the cutter 100 hits the bent portion of the outer surface 82 due to elastic deformation.
  • the size of the cuts 94a to 94c is smaller at the outer surface 82 opening than at the inner surface 80 opening.
  • the amount of protrusion toward the outer surface 82 due to the bending deformation of the central portion 76 is limited by the contact of the outer surface 82 with the jig 98.
  • the predetermined slit 92 is formed through the central portion 76 by extracting the cutter 100 from the central portion 76 of the elastic valve body 40 toward the inner surface 80.
  • the radial dimension gradually increases toward the inner surface 80 using the elasticity of the elastic valve body 40.
  • 94a to 94c can be formed. For this reason, the above-mentioned cut can be easily provided in the valve without adopting a special cutter shape.
  • the angle of inclination of the notches 94a to 94c with respect to the axial direction is adjusted by limiting the amount of bending deformation of the central portion 76 by contacting the outer surface 82 with the jig 98.
  • the cutter 100 for slit formation in the present embodiment is formed by integrally combining three plate-shaped blades arranged in a three-way radial shape corresponding to the slit shape.
  • the inclination angle of the outer peripheral ends of the cuts 94a to 94c is appropriately set by adjusting the amount of elastic deformation of the elastic valve body 40 due to the pressing of the cutter 100. can do. That is, the elastic valve body 40 is supported so that elastic deformation to the outer surface 82 side of the central portion 76 is allowed freely, and the inclination angle is set large, or as shown in FIG. It is possible to set the inclination angle appropriately by supporting so that the amount of elastic deformation of 76 on the outer surface 82 side is limited.
  • the inclination angle of the outer peripheral end portions of the cuts 94a to 94c can also be adjusted by adjusting the frictional resistance of the blade of the cutter 100 with respect to the elastic valve body 40. It can. Specifically, for example, by applying a lubricant to the surface of the blade of the cutter 100 or forming the elastic valve body 40 with a self-lubricating rubber elastic body, the friction resistance is reduced, thereby reducing the cutter 100. At the time of cutting, the amount of bending deformation of the central portion 76 can be reduced, and the inclination angle can be set small. On the other hand, by increasing the frictional resistance by roughening the surface of the blade of the cutter 100 or forming the elastic valve body 40 from a rubber material having low lubricity, the inclination angle can be set large. it can.
  • the outer peripheral end of the slit 92 can be inclined at an angle corresponding to the laser irradiation direction without substantially deforming the central portion 76 of the elastic valve element 40.
  • FIG. 10 shows the respective radial dimensions of the inner surface 80 opening and the outer surface 82 opening of the cuts 94a to 94c in the 20 elastic valve bodies 40 in which the slits 92 are formed by the manufacturing method as in this embodiment.
  • the actual measurement results are shown.
  • the radial dimensions of the cuts 94a to 94c on the outer surface 82 are set in the range of 0.51 to 0.77 mm
  • the radial dimensions of the cuts 94a to 94c on the inner surface 80 are It is set in the range of 1.31 to 1.57 mm.
  • the formed slit 92 is sized to fit within the male luer tip.
  • the elastic valve body 40 is advantageously brought into close contact with the entire outer peripheral surface of the male luer tip, and a high degree of liquid tightness can be obtained more stably. Can do.
  • the elastic valve body 40 having the slit 92 as described above is attached to the cylindrical mouth body 38 with the outer peripheral portion supported by the cylindrical mouth body 38. That is, the elastic valve body 40 is inserted into the opening 50 of the small diameter cylindrical portion 48 of the cylindrical mouth body 38, and the lower part of the annular fixing portion 78 of the elastic valve body 40 is located above the annular protrusion 54 of the cylindrical mouth body 38.
  • the inner peripheral surface of the lower portion of the annular fixing portion 78 is overlapped with the outer peripheral surface of the locking projection 56.
  • the opening locking piece 65 is overlapped from above the elastic valve body 40, and the upper portion of the annular fixing portion 78 is overlapped with the lower end surface 70 of the opening locking piece 65 and the outer peripheral surface of the locking protrusion 74.
  • the locking projection 56 provided on the annular protrusion 54 of the cylindrical mouth body 38 is inserted into the annular groove 84 of the elastic valve body 40, and the locking provided on the opening locking piece 65.
  • the protrusion 74 is inserted into the annular groove 86 of the elastic valve body 40, and the locking protrusions 56 and 74 are locked to the annular grooves 84 and 86.
  • the elastic valve body 40 is mounted on the cylindrical mouth body 38 with the constricted portion 88 held in the axial direction between the locking projection 56 and the locking projection 74 of the cylindrical mouth body 38. ing.
  • the protrusion height dimension of the locking protrusion 56 is equal to or slightly larger than the groove depth dimension of the annular groove 84 formed on the inner surface 80 of the elastic valve body 40 from the inner surface 80 of the annular fixing part 78. It is preferable that Thereby, generation
  • the depth dimension of the fitting concave groove 58 is the projecting height dimension of the locking projection 56 and is equal to or slightly larger than the depth dimension of the annular groove 84 of the elastic valve body 40.
  • the groove width dimension in the radial direction of the fitting concave groove 58 is the same as the width dimension of the portion protruding axially inward (inner surface 80 side) from the constricted part 88 in the annular fixing part 78 of the elastic valve body 40. Or slightly smaller. Thereby, the annular fixing portion 78 of the elastic valve body 40 is brought into contact with the entire inner surface of the fitting groove 58 in a tight contact state, and a gap in the fitting groove 58 is prevented.
  • the protruding height dimension of the locking protrusion 74 is the same as or slightly larger than the protruding height dimension of the annular fixing portion 78 of the elastic valve body 40 from the constricted portion 88.
  • tip part of the latching protrusion 74 is contact
  • the inner diameter dimension of the through hole 66 is 4.4 mm so as not to hinder the connection operation of the male connector. It is preferable to set as described above. If the inner diameter of the through hole 66 is smaller than 4.4 mm, the luer tip 112 and the opening locking piece 65 come into contact with each other and damage the luer tip 112 when the standard luer lock connector 110 defined by ISO594 is inserted. This is because the airtightness at the time of connection may be impaired.
  • attached the elastic valve body 40 to the cylindrical opening 38 is attached to the 3rd branch opening part 28 of the 3rd branch pipe 22, and the 3rd branch opening part 28 is an elastic valve.
  • the body 40 is hermetically closed.
  • the annular fixing portion 78 of the elastic valve body 40 is fitted into the fitting groove 58, and the locking projection 56 formed on the cylindrical mouth body 38 is formed on the inner surface 80 of the elastic valve body 40. It is inserted in the formed annular groove 84.
  • the constricted portion 88 of the elastic valve body 40 is sandwiched and supported in the axial direction by the locking protrusion 56 and the locking protrusion 74 that protrude in the mutually opposing direction. Yes.
  • opening latching piece 65 with respect to the cylindrical mouth body 38 is advantageously realized by, for example, swaging. Specifically, as shown in FIG. 5, after the elastic valve body 40 is fitted into the cylindrical mouth body 38, ultrasonic vibration or high-frequency induction heating is used for the upper end portion of the cylindrical mouth body 38. By performing the swaging process, the upper end portion of the cylindrical mouth body 38 is deformed radially inward while being melted, and the opening locking piece 65 is formed.
  • the large-diameter cylindrical portion 46 of the cylindrical mouth body 38 is connected to the opening of the third branch pipe 22 in the holder 12, and the large-diameter cylindrical section 46 is connected to the third branch pipe 22. It is fixed by being covered with a connecting member 108 to be screwed.
  • the first branch opening 24 is connected to the tube on the upstream side of the infusion route
  • the second branch opening 26 is connected to the tube on the downstream side.
  • the first branch pipe 18 and the second branch pipe 20 constitute a part of the infusion route and are disposed on the infusion route.
  • a luer lock connector 110 as a male connector is connected to the mixed injection port 36 provided in the third branch opening 28.
  • 11A shows a state before the luer lock connector 110 is connected
  • FIG. 11B shows a connection state of the luer lock connector 110.
  • the luer lock connector 110 is a conventionally known one having a standard size defined by, for example, ISO 594, and includes a luer tip 112 having a tapered cylindrical taper shape and forming an external flow path, and an outer peripheral portion of the luer tip 112. A surrounding female screw portion 114 is provided.
  • the luer tip 112 is pushed into the elastic valve body 40 while the female screw portion 114 and the male screw portion 64 of the mixed injection port 36 are screwed together.
  • the annular fixing portion 78 is locked by the locking projection 56 and the locking projection 74.
  • the center part 76 of the elastic valve body 40 is pushed inward of the cylindrical mouth body 38, and the slit 92 is expanded.
  • the luer tip 112 penetrates the elastic valve body 40, and the tip opening 116 is opened in the internal space of the cylindrical mouth body 38 and connected to the luer tip 112.
  • the internal space such as a syringe is connected to the internal flow path of the third branch pipe 22 through the external flow path in the luer tip 112.
  • the threaded portion 114 of the luer lock connector 110 is screwed with the threaded portion 64 of the co-injection port 36, so that the insertion state of the luer tip 112 is reliably maintained.
  • the cock 14 is operated to bring the third branch pipe 22 and the second branch pipe 20 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 112 is removed, the central portion 76 is returned to the disk shape by the elastic restoring force of the elastic valve body 40, and the slit 92 is closed substantially airtightly. .
  • the slit 92 formed in the central portion 76 of the elastic valve body 40 has a radial shape constituted by cuts 94a to 94c extending in three radial directions. Yes.
  • the portion of the elastic valve body 40 where the slit 92 is formed is easily deformed, and the frictional force acting between the outer peripheral surface of the luer tip 112 and the elastic valve body 40. Is reduced.
  • the luer tip 112 can be easily inserted into the slit 92, and the elastic valve body 40 can be prevented from being pushed into the fluid flow path side and falling off the cylindrical mouth body 38.
  • the slit 92 is formed by the three cuts 94a to 94c, the slit 92 is prevented from being easily opened more than necessary, and the airtightness of the slit 92 is ensured at the time of blocking. Leakage through the liquid is prevented. Moreover, since the three cuts 94a to 94c are evenly arranged on the circumference, the stress acting when the luer tip 112 is inserted into the slit 92 is dispersed, and the durability of the elastic valve body 40 is improved. Figured.
  • the three cuts 94a to 94c all extend linearly in the radial direction. Therefore, when the lure tip 112 is inserted into and removed from the slit 92, problems such as the deformation of the elastic valve body 40 being restricted due to the catches on the inner surfaces of the cuts 94a to 94c are avoided, and a stable opening and closing operation of the slit 92 is realized. Is done.
  • the central portion 76 in which the slit 92 is formed has a flat plate shape formed with a substantially constant thickness, and the axial dimension L of the slit 92 is substantially constant.
  • the three cuts 94a to 94c have outer peripheral end portions inclined with respect to the axial direction, and the opening on the inner surface 80 side has a larger radial dimension than the opening on the outer surface 82 side. According to this, even when the fluid pressure in the fluid flow path is exerted on the inner surface 80 side in the cut-off state of the slit 92, the three cuts 94a to 94c are stably held in the cut-off state. Accordingly, liquid leakage is prevented when the hydraulic pressure acts on the inner surface 80 of the central portion 76 of the elastic valve body 40. Furthermore, when the luer lock connector 112 is connected, the inner surface 80 of the elastic valve body 40 is more likely to be turned and elastically deformed, so that the insertion resistance of the luer tip 112 can be further reduced.
  • the slit 92 is stably held in the cut-off state by adopting such incisions 94a to 94c whose outer peripheral end portions are inclined for the following reasons, for example. That is, the radial dimensions of the three cuts 94a to 94c constituting the slit 92 are made larger on the inner surface 80 than on the outer surface 82, thereby expanding toward the inner surface 80 side including the outer peripheral ends of the cuts 94a to 94c.
  • the open virtual frustum surface is a surface that substantially supports the portion of the central portion 76 located between the notches 94a to 94c in the circumferential direction.
  • the elastic valve body 40 (Example) having the cuts 94a to 94c in which the opening on the inner surface 80 is larger than the opening on the outer surface 82, and the slit formed with the cuts on the outer surface 82 larger than the opening on the inner surface 80.
  • the maximum hydraulic pressure to the inner surface 80 that causes liquid leakage through the slit is shown. According to this, in the example, it is clear from the measurement result that the liquid leakage through the slit does not occur until a higher pressure is applied to the inner surface 80 of the central portion 76 as compared with the comparative example. is there.
  • the difference obtained by subtracting the radial dimension of the outer surface 82 opening from the radial dimension of the inner surface 80 opening is 0. .5 mm.
  • the difference obtained by subtracting the radial dimension of the outer surface 82 opening from the radial dimension of the inner surface 80 opening is ⁇ 0.5 mm.
  • the elastic valve body 40 is made of isoprene, and the thickness dimension of the central portion 76 is 1.8 mm.
  • the concave groove portion 90 of the elastic valve body 40, the engagement protrusion 56 with which the elastic valve body 40 abuts, and the contact inner peripheral surface 60 of the annular protrusion 54 are curved concave shapes corresponding to each other. It is formed with a cross section and a curved convex cross section. Therefore, in a state where the luer tip 112 is inserted into the slit 92, the concave groove portion 90 and the contact inner peripheral surface 60 are stably in contact with each other, and the generation of a gap between the contact surfaces is prevented. The As a result, entry and retention of the chemical solution due to the occurrence of the gap can be effectively avoided.
  • the locking protrusion 56 and the annular protrusion are formed by the concave groove portion 90 formed in the elastic valve body 40.
  • a recess having a sufficiently large opening width is formed on the surface of the contact inner peripheral surface 60 of the seat 54. Therefore, even if the chemical solution has entered the concave groove portion 90, a sufficiently large gravity is applied to the force that stops at the concave groove portion 90 due to the surface tension, and the chemical solution stays in the concave groove portion 90. Can be effectively avoided.
  • the stress generated in the elastic valve body 40 due to the bending deformation when the luer tip 112 is inserted is dispersed by the curved concave cross section set in the concave groove portion 90.
  • the elastic valve body 40, the locking protrusion 56 and the annular protrusion 54 with which the elastic valve body 40 abuts are formed with a curved concave cross section and a curved convex cross section corresponding to each other. Further dispersion effects of stress and deformation in the body 40 are exhibited. Thereby, the fall of the durability resulting from the local effect
  • the surface length of the recessed groove portion 90 in the free state before the luer tip 112 is inserted is set to be smaller than the surface length of the contact inner peripheral surface 60 of the locking protrusion 56 and the annular protrusion 54. .
  • the inner surface 80 of the central portion 76 of the elastic valve body 40 abuts against the cylindrical surface 62 of the small diameter cylindrical portion 48, The insertion end position of the luer tip 112 is defined. Therefore, as compared with the case where the insertion end position of the luer tip 112 is defined by direct contact with the cylindrical mouth body 38, sufficient compression is performed on the elastic valve body 40 at the insertion end position of the luer tip 112. Power can be exerted stably. As a result, the sealing effect by the elastic valve body 40 can be stably obtained, and the reliability of the sealing performance of the fluid flow path can be improved.
  • the luer tip 112 In the connected state of the luer lock connector 110, the luer tip 112 is held only by the elastic valve body 40 and is not in contact with the cylindrical mouth body 38. As a result, it is possible to completely avoid the trouble that the resin scraped due to the luer tip 112 rubbing against the cylindrical mouth body 38 or the like is mixed into the fluid flow path, and further improve the hygiene. Achieved.
  • a luer lock type connector having a female threaded portion 114 is illustrated as a male connector, but a so-called luer slip type connector that does not have the female threaded portion 114 and includes only the luer tip 112 is of course also possible. Connectable. In particular, in the case of a luer slip type connector, the connection state of the luer tip 112 is maintained only by the elastic restoring force of the elastic valve body 40. Further, when only the luer slip type is targeted as the male connector, the stepped shape of the cylindrical mouth body 38 and the male screw portion 64 are not necessarily required.
  • the slit 92 in which the three cuts 94a to 94c are radially arranged in three directions is illustrated, but the slit may be formed by three or more cuts.
  • the slit 122 may be composed of four cuts 94a to 94d arranged in a cross shape, or five or more cuts 94. It may be configured.
  • the slits forming the slits are equally arranged so as to form an equal angle in the circumferential direction, but they may be arranged biased on the circumference.
  • the slits forming the slit are formed with uniform radial dimensions, but the slits may be formed with different radial dimensions.
  • the cut does not necessarily extend linearly toward the outer periphery as viewed in the axial direction, and may extend in a curved or refracted manner.
  • the inclination angle of the outer peripheral edge of the cut is not particularly limited, and can be arbitrarily set according to required pressure resistance, durability, and the like.
  • the outer peripheral end of the cut does not necessarily have to be inclined at a constant angle with respect to the axial direction.
  • the size of the concave groove portion 90 is set to such an extent that the liquid does not stay in the concave groove portion 90 due to the action of surface tension in consideration of the viscosity and specific gravity of the liquid used.
  • the radial width dimension and depth dimension of the recessed groove portion 90 are not limitedly interpreted.
  • the annular protrusion 54 is formed on the cylindrical mouth body 38, and the elastic valve body 40 is supported by the cylindrical mouth body 38 formed separately from the holder 12.
  • a valve seat may be directly formed in the opening portion of the third branch pipe 22 in the holder 12.

Landscapes

  • 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

La présente invention concerne : un connecteur médical, qui présente une nouvelle structure, le connecteur médical étant conçu de manière à ce qu'un corps de vanne élastique ne sorte pas d'un logement ; et un procédé de fabrication du connecteur médical. Un connecteur médical (36) est conçu de manière à ce qu'un corps (40) de vanne élastique, en forme de disque, ayant une fente (92) formé dans sa région centrale (76) de manière à pénétrer à travers, soit monté sur un logement (38) qui forme une partie d'ouverture d'un parcours d'écoulement fluidique. La fente (92) formée dans le corps (40) de vanne élastique comprend au minimum trois découpes (94) qui s'étendent radialement depuis la partie centrale du corps (40) de vanne élastique, vers le côté de périphérie extérieure.
PCT/JP2013/075590 2012-09-21 2013-09-20 Connecteur médical et son procédé de fabrication WO2014046271A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2014536950A JP6678390B2 (ja) 2012-09-21 2013-09-20 医療用コネクタとその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012208565 2012-09-21
JP2012-208565 2012-09-21

Publications (1)

Publication Number Publication Date
WO2014046271A1 true WO2014046271A1 (fr) 2014-03-27

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JP (2) JP6678390B2 (fr)
WO (1) WO2014046271A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015221108A (ja) * 2014-05-22 2015-12-10 ニプロ株式会社 医療用弁
JP2016150063A (ja) * 2015-02-16 2016-08-22 ニプロ株式会社 医療用弁
CN109432589A (zh) * 2018-12-26 2019-03-08 台州市路桥瑞豪科技有限公司 无针加药接头的制作工艺
JP2020503971A (ja) * 2017-01-12 2020-02-06 ベクトン ディキンソン アンド カンパニー リミテッド 閉鎖系応力抵抗膜
EP3932467A1 (fr) * 2020-06-30 2022-01-05 Illinois Tool Works Inc. Soupape anti-écoulement libre
CN115209941A (zh) * 2020-01-27 2022-10-18 贝克顿·迪金森公司 旋转鲁尔连接器

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3884990A4 (fr) 2018-11-20 2022-11-16 Nipro Corporation Raccord mâle

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JPH01139077A (ja) * 1987-09-21 1989-05-31 Cordis Corp 医療器具バルブ
JPH0647093A (ja) * 1992-06-18 1994-02-22 Becton Dickinson & Co 液体注入装置
JP2000135291A (ja) * 1998-10-30 2000-05-16 Clinical Supply:Kk 医療用弁体
JP2003275279A (ja) * 2002-03-27 2003-09-30 Jms Co Ltd 医療用混注口
JP2009011820A (ja) * 2007-06-05 2009-01-22 Nipro Corp 医療用コネクタおよびその製造方法
WO2010073643A1 (fr) * 2008-12-26 2010-07-01 二プロ株式会社 Raccord médical

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MY166115A (en) * 2010-09-28 2018-05-24 Terumo Corp Connector

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Publication number Priority date Publication date Assignee Title
JPH01139077A (ja) * 1987-09-21 1989-05-31 Cordis Corp 医療器具バルブ
JPH0647093A (ja) * 1992-06-18 1994-02-22 Becton Dickinson & Co 液体注入装置
JP2000135291A (ja) * 1998-10-30 2000-05-16 Clinical Supply:Kk 医療用弁体
JP2003275279A (ja) * 2002-03-27 2003-09-30 Jms Co Ltd 医療用混注口
JP2009011820A (ja) * 2007-06-05 2009-01-22 Nipro Corp 医療用コネクタおよびその製造方法
WO2010073643A1 (fr) * 2008-12-26 2010-07-01 二プロ株式会社 Raccord médical

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015221108A (ja) * 2014-05-22 2015-12-10 ニプロ株式会社 医療用弁
JP2016150063A (ja) * 2015-02-16 2016-08-22 ニプロ株式会社 医療用弁
JP2020503971A (ja) * 2017-01-12 2020-02-06 ベクトン ディキンソン アンド カンパニー リミテッド 閉鎖系応力抵抗膜
JP7066723B2 (ja) 2017-01-12 2022-05-13 ベクトン ディキンソン アンド カンパニー リミテッド 閉鎖系応力抵抗膜
JP2022097585A (ja) * 2017-01-12 2022-06-30 ベクトン ディキンソン アンド カンパニー リミテッド 閉鎖系応力抵抗膜
JP7258202B2 (ja) 2017-01-12 2023-04-14 ベクトン ディキンソン アンド カンパニー リミテッド 閉鎖系応力抵抗膜
CN109432589A (zh) * 2018-12-26 2019-03-08 台州市路桥瑞豪科技有限公司 无针加药接头的制作工艺
CN115209941A (zh) * 2020-01-27 2022-10-18 贝克顿·迪金森公司 旋转鲁尔连接器
EP3932467A1 (fr) * 2020-06-30 2022-01-05 Illinois Tool Works Inc. Soupape anti-écoulement libre
US11560953B2 (en) 2020-06-30 2023-01-24 Illinois Tool Works Inc. Anti-free-flow valve

Also Published As

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JP2019072648A (ja) 2019-05-16
JPWO2014046271A1 (ja) 2016-08-18
JP6678390B2 (ja) 2020-04-08

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