JP2020005689A - Medical male connector - Google Patents

Abstract

To provide a male connector with high fluid-tightness that can be connected and detached easily.SOLUTION: A male connector 100 includes a connection convex part 110 inserted into a connection concave part 210 of a female connector 200 which has a tapered outer surface 120 whose diameter is gradually increased from the tip to the base end side. The tapered outer surface 120 includes a hard surface 121 provided at the tip and a soft surface 122 provided closer to the base end side than the hard surface 121.SELECTED DRAWING: Figure 2

Description

  The present disclosure relates to a medical male connector.

  Various infusion lines are connected to the medical device. It is common to use a luer connector for such a connection. The luer connector realizes a connection with high liquid tightness by bringing the tapered surfaces of the male connector and the female connector into surface contact with each other. The shape of the tapered surface of the luer connector for medical use is defined by the ISO standard, and connection can be made even if the manufacturer is different.

  However, even between luer connectors that conform to the standard, there is a delicate compatibility, and loosening may easily occur, or sufficient liquid tightness may not be exhibited unless a large force is applied.

  In order to improve the liquid tightness of the connector, a groove is provided in the tapered surface to fit an O-ring (for example, see Patent Document 1), or the material of the tip portion of the tapered surface is made of a flexible material such as silicon rubber. (See, for example, Patent Document 2).

JP 2005-143832A JP 2011-525596 A

  However, when the O-ring is fitted, only the O-ring comes into contact with the inner surface of the female connector, so that there is a problem that the engagement surface with the inner surface of the female connector is small. When the distal end of the connector is made of silicon rubber or the like, the tapered surface of the distal end can be brought into surface contact, but there is a problem that the distal end is easily worn. Specifically, when the male connector is inserted into the female connector, the distal end serves as a guide. However, when the distal end is made of silicon rubber or the like, there is a problem that the distal end is damaged.

  An object of the present disclosure is to realize a novel medical connector that is easily connected and has high liquid tightness.

  One aspect of the male connector of the present disclosure includes a connection protrusion having a tapered outer surface that is gradually inserted from the distal end toward the base end and that is inserted into the connection recess of the female connector. The outer surface has a hard surface provided at the distal end, and a soft surface provided proximal to the hard surface.

  According to one aspect of the male connector, the tip portion is less likely to be worn or damaged at the time of connection, and the fitting force by the soft surface suitably realizes surface contact.

  In one aspect of the male connector, the connection protrusion is formed of a material having a side recess provided closer to the base end than the distal end, and a material more flexible than the protrusion body so as to fill the side recess. It is preferable to have a flexible portion that forms a soft surface. With this configuration, it is possible to prevent the flow path from being deformed or blocked.

  In one aspect of the male connector, when the connection projection is inserted into the connection recess, the base end of the soft surface may protrude from the connection recess. With such a configuration, it is possible to increase the ratio of the flexible portion in contact with the tapered surface of the female connector.

  Another aspect of the male connector of the present disclosure includes a connection protrusion having a tapered outer surface that is gradually inserted from the distal end toward the proximal end and that is inserted into the female connector. Has a soft surface, and the connection projection has a hard surface on the tip side from the soft surface.

  One aspect of the method for manufacturing a male connector of the present disclosure includes a step of forming a connection protrusion inserted into the connection recess of the female connector, and the step of forming the connection protrusion includes a step of forming the side recess at a position separated from the tip. Molding the convex part body having a flexible part made of a material that is more flexible than the convex part body so that the distal end surface and the inner surface of the flexible part are fixed to the distal end surface and the outer surface of the side concave part without gaps. Including a step of providing the side surface concave portion, having a hard surface provided at the distal end, a soft surface provided on the base end side than the hard surface, the outer surface where the hard surface and the soft surface are continuous Form.

  According to one aspect of the method of manufacturing a male connector, a male connector having an outer surface that easily makes surface contact with a connection recess of a female connector can be formed with high dimensional accuracy. Further, the flexible portion can be firmly fixed to the reduced diameter portion.

  In one aspect of the male connector, the flexible portion can be integrally formed with the side recess. With this configuration, the flexible portion is firmly integrated with the other portion of the connection protrusion, so that the flexible portion is less likely to drop or twist.

  According to the male connector of the present disclosure, a medical connector that is easily connected and has high liquid tightness can be realized.

It is sectional drawing which shows the male connector which concerns on one Embodiment. It is sectional drawing which shows the state which connected the male connector which concerns on one Embodiment with the female connector. It is sectional drawing which shows the modification of the male connector which concerns on one Embodiment.

  As shown in FIGS. 1 and 2, the male connector 100 according to the present embodiment has a tapered outer surface 120 that is inserted into the connection recess 210 of the female connector 200 and has a diameter that gradually increases from the distal end toward the proximal end. Is provided. The outer surface 120 of the connection protrusion 110 has a hard surface 121 provided at the distal end and a soft surface 122 provided at the base end side of the hard surface 121.

  In the present embodiment, the connection protrusion 110 has a protrusion main body 111 and a flexible portion 112 made of a material that is more flexible than the protrusion main body 111. In this embodiment, the convex portion main body 111 has a reduced diameter portion 111a (side surface concave portion) reduced in diameter between the front end portion and the rear end portion, and the flexible portion 112 has a cylindrical shape that fills the reduced diameter portion 111a. It is provided in. The tip of the convex body 111 forms a hard surface 121, and the flexible portion 112 embedded in the reduced diameter portion 111 a forms a soft surface 122. A base end side of the outer surface 120 from the soft surface 122 is a hard base end surface 123.

  In the male connector 100 of the present embodiment, the outer surface 120 of the connection projection 110 has a tapered shape conforming to the standard of a standard male luer connector for medical use. When the connection protrusion 110 is inserted into the connection recess 210 of the female connector 200 conforming to the standard of a standard female luer connector for medical use, the outer surface 120 of the connection protrusion 110 becomes the inner surface of the connection recess 210 of the female connector 200. And can be connected in a liquid-tight manner.

  The male connector 100 of the present embodiment is provided with a soft surface 122 on the outer surface 120 of the connection protrusion 110, and a continuous taper in which the hard surface 121 and the soft surface 122 are in surface contact with the inner surface of the connection recess 210. Forming a surface. For this reason, the male connector 100 has a fitting force peculiar to a soft member, and is formed between the tapered surface of the connection convex portion 110 and the tapered surface of the connection concave portion 210 due to a manufacturing tolerance or a different manufacturer of the female connector 200. Even if there is a slight difference in the shape, a connection with high liquid tightness can be achieved by absorbing the difference. Further, unlike the O-ring, it is possible to secure liquid tightness without applying a large force, and it is possible to prevent a problem that the connector is damaged at the time of connection or the connector cannot be separated.

  The boundary between the soft surface 122 and the hard surface 121 on the distal end side is preferably continuous without any step. Here, “continuous without a step” means that no step is recognized at a visual level. If the step is about 0.1 mm or less that cannot be easily recognized by the naked eye, the outer surface of the connection projection 110 will have a tapered female connector 200 even if it exists at the boundary between the soft surface 122 and the hard surface 121. Is formed in a tapered shape that easily comes into surface contact with the inner surface of the connection recess 210. Note that the outer surface of the connection projection 110 may be substantially tapered (to the extent that engagement by surface contact with the female connector is realized). The boundary with the hard surface 121 may have some steps, and the taper angle of the soft surface 122 may be slightly different from the taper angle of the hard surface 121.

  It is preferable that the boundary between the soft surface 122 and the proximal surface 123 is also continuous without any step. However, when the boundary between the soft surface 122 and the proximal surface 123 does not enter the connection recess 210 when the female connector 200 is connected, the boundary between the soft surface 122 and the proximal surface 123 A large step may exist. 1 and 2, the flexible portion 112 is fixed to the reduced diameter portion 111a provided at the intermediate portion of the convex main body 111, and the proximal surface 123 is located closer to the proximal side than the soft surface 122. An example is shown. However, a configuration in which the base surface 123 does not exist and the outer surface 120 except the hard surface 121 is entirely a soft surface 122 may be employed. However, by providing the reduced diameter portion 111a in the middle of the convex main body 111, the flexible portion 112 can be firmly fixed in the axial direction.

  In the case of a conventional male connector provided with an O-ring in the middle of the connection protrusion, the O-ring is mounted on the groove on the outer peripheral surface of the connector in a state of protruding from the tapered surface, and the O-ring moves relative to the male connector. It's easy to do. Further, the O-ring is crushed by inserting the male connector into the female connector, and sealing is performed by a repulsive force generated between the O-ring and the wall surfaces of the male connector and the female connector. Therefore, even when the male connector is removed from the female connector, a large force is applied to the O-ring, and the O-ring may move relatively. In addition, there is a problem that a dead space occurs on the tip side from the O-ring. On the other hand, since the soft surface 122 of the male connector 100 of the present embodiment forms a tapered surface, when the male connector is removed from the female connector, no excessive force is applied to the soft surface 122, and the soft surface 122 is removed. It is unlikely that the constituent flexible portion 112 will move relative to the male connector. Further, the male connector and the female connector can be entirely engaged.

  In the case where an O-ring that is crushed is provided in the middle of the connection protrusion, when inserting the male connector into the female connector, it is necessary to apply a large force to crush the O-ring. Further, there is a possibility that the user may perform an operation of forcibly pushing the male connector with the O-ring. On the other hand, the male connector 100 of the present embodiment can engage the male connector with the female connector by the same operation as a normal male connector, and can be used without the user having to worry about the insertion feeling. Also, there is no need to apply a large force until the engagement. A situation in which the connector is fixed or damaged is less likely to occur.

  If the entire connection protrusion or the portion including the distal end is formed of a flexible material, the flexible distal end may be worn or damaged when the male connector is attached or detached. In addition, when the male connector is connected, if the connector is twisted, it is connected in a state where the soft tip is twisted, and there is a possibility that a liquid leak occurs or the connector is easily detached. In the male connector 100 of the present embodiment, since the distal end portion 121 has the hard surface 121 formed of a material having normal hardness, the distal end portion is hardly abraded or damaged, and the distal end portion is not likely to be twisted. Therefore, a situation in which the connectivity and the liquid tightness are reduced due to the attachment / detachment of the connector is prevented.

  Further, the distal end of the male connector is structurally in contact with the liquid passing through the connector. Soft members, such as rubber, are inferior in stability to hard members. Therefore, when touching a liquid, there is a possibility that a plasticizer or the like is eluted or reacts with a component contained in the liquid. In the male connector 100 of the present embodiment, the soft surface 122 is located closer to the base end than the hard surface 121 provided at the distal end, and the risk that the soft surface 122 comes into contact with the liquid can be significantly reduced.

  Further, in the case of a male connector having at least the tip formed of a flexible material, it becomes difficult to push and expand a check valve or the like provided in the female connector. However, the male connector 100 of the present embodiment can be connected to a female connector provided with a check valve or the like, similarly to a normal male connector.

  The axial length of the hard surface 121 provided at the tip is preferably 0.3 mm or more, more preferably 0.5 mm or more, and preferably 2.2 mm or less, from the viewpoint of reducing the risk of abrasion and liquid contact. Preferably it is 1.7 mm or less. In addition, it is preferable that the front-end | tip part is given the round process, and it is preferable that it is thick.

  When the soft surface 122 is connected to the female connector 200, it is preferable that the base end of the soft surface 122 does not enter the connection recess 210 and the base end of the soft surface protrudes from the connection recess 210. The base end of the fitting surface between the connection concave portion and the connection convex portion is usually formed at a position of 5.0 mm to 6.5 mm from the distal end of the connection convex portion. It is preferably formed on the proximal end side about 5.0 mm from the distal end, and is preferably formed on the proximal end side about 6.5 mm from the distal end of the connection projection. In such a case, since most of the portion of the outer surface of the connection protrusion 110 that is in contact with the inner surface of the connection recess 210 becomes the soft surface 122, the close contact between the outer surface of the connection protrusion 110 and the inner surface of the connection recess 210 is made. Properties can be further improved. However, it is also possible that all of the soft surface 122 is accommodated in the connection recess 210 when connected to the female connector 200.

  The axial length of the soft surface 122 is preferably 3 mm or more, more preferably 5 mm or more, preferably 9 mm or less, more preferably 8.5 mm or less, from the viewpoint of exhibiting the effect of improving the connectivity by the soft surface 122. is there. Note that the axial length of the hard surface 121 and the axial length of the soft surface 122 are not the length of the tapered surface but the length along the axis C of the male connector 100.

  In the male connector 100 of the present embodiment, the reduced diameter portion 123 of the convex main body 111 is a concave portion dug down from the original tapered surface, and the flexible portion 112 has a shape complementary to the reduced diameter portion 123 which is the concave portion. is there. From the viewpoint of forming the flexible portion 112 having a certain thickness, the outer diameter of the reduced diameter portion 123 is preferably 97% or less, more preferably 95% or less of the outer diameter of the original tapered surface. From the viewpoint of securing the strength of the tapered surface, the outer diameter is preferably 87% or more, more preferably 90% or more of the original outer diameter of the tapered surface. For example, in the case of a male luer connector of a normal standard size, it is preferably 0.12 mm or more, more preferably 0.2 mm or more, preferably 0.5 mm or less, more preferably 0.4 mm or less from the original tapered surface. Recess.

  FIG. 1 shows an example in which the diameter-reduced portion 123 has a tapered shape in which the depth from the original tapered surface of the connection convex portion 110 is constant and the diameter gradually increases from the distal end toward the proximal end. The shape of the reduced diameter portion may be freely changed. For example, the outer diameter of the reduced diameter portion 123 can be made constant from the distal end side to the proximal end side, or can be made discontinuous.

  The protrusion main body 111 can be formed of a resin that forms a normal medical connector. For example, acrylic, polycarbonate, polyethersulfone, hard vinyl chloride, polyethylene terephthalate, polyethylene, polypropylene and the like can be used.

  The flexible part 112 can be formed of a material that is more flexible than the convex part main body 111. For example, medical rubber materials such as silicone rubber and fluorine rubber, elastomers such as urethane, and soft resins such as soft vinyl chloride can be used.

  The male connector of the present embodiment is formed of, for example, a material that is more flexible than the protrusion main body 111 after first forming a hard portion including the protrusion main body 111 having the reduced diameter portion 111a at a position separated from the distal end. The flexible portion 112 can be manufactured by providing the flexible portion 112 on the reduced diameter portion 111a such that the distal end surface and the inner surface of the flexible portion 112 are fixed to the distal end surface 111b and the outer surface of the reduced diameter portion 111a. Thus, an outer surface having a hard surface 121 provided at the distal end portion and a soft surface 122 provided closer to the base end side than the hard surface 121, wherein the hard surface 121 and the soft surface 122 are continuous and have no step. 120 can be easily formed. Further, it is easy to form the tapered outer surface 120 whose diameter gradually increases from the distal end toward the proximal end. It is preferable that the distal end surface and the inner surface of the flexible portion 112 constituting the soft surface 122 are fixed to the entirety of the distal end surface 111b and the outer surface of the reduced diameter portion 111a. This makes it difficult for the flexible portion 112 to relatively move.

  In addition, it is preferable to form the flexible portion 112 integrally with the reduced diameter portion 111a from the viewpoint of more firmly fixing the flexible portion 112. By integral molding, the distal end surface and the inner surface of the flexible portion 112 and the distal end surface 111b and the outer surface of the reduced diameter portion 111a can be easily brought into close contact with each other without any gap and fixed. Above all, from the viewpoint of the close contact with the convex main body 111 of the flexible part 112 and the dimensional accuracy of the outer surface 120, the molding of the hard part including the convex main body 111 and the integral molding of the flexible part 112 are performed by two-color molding. Is preferred. Since the flexible portion 112 is firmly integrated with the other portion of the convex portion main body 111, the flexible portion 112 can be hardly dropped or twisted during use. Further, by improving the dimensional accuracy, the female connector 200 can be easily brought into surface contact with the inner surface of the connection recess 210.

  However, instead of two-color molding, insert molding in which the hard portion including the convex main body 111 is molded and then the flexible portion 112 is integrally molded by another molding machine may be used. Further, the hard portion including the convex main body 111 and the flexible portion 112 may be assembled separately after being formed separately, instead of being integrally formed. Further, the portion including the convex portion main body 111 can be constituted by a plurality of members.

  FIGS. 1 and 2 show the male connector 100 which is a slip connector, but may be a lock connector as shown in FIG. The male connector 100A shown in FIG. 3 has a lock nut 150 provided around the connection projection 110. The lock nut 150 has a thread 151 that engages with a thread provided on the outer peripheral surface of the female connector. By providing the lock nut 150, the connection reliability of the connector can be further improved. The lock nut 150 may be configured to be fixed to the connection protrusion 110 and not rotate freely, or may be configured to rotate freely with respect to the connection protrusion 110.

  In FIG. 1, an example in which a hub 130 having a diameter larger than that of the connection protrusion 110 is provided on the base end side of the connection protrusion 110, and a tube connection portion 140 for connecting a tube to the base end side of the hub 130 is provided. Is shown. The shape of the hub 130 is not particularly limited, and may be a shape that can be easily gripped. The hub 130 may be provided as needed, and may not be provided. The tube connecting portion 140 can have a configuration in which a tube can be fitted, for example, but may have any configuration as long as the tube can be connected. The hub 130 and the tube connection portion 140 can be integrally formed with the connection protrusion 110, but can be formed separately from the connection protrusion 110 and then integrated.

  Further, the male connector of the present embodiment is not limited to the configuration in which the tube is connected to the base end side. It can be used for any application that uses a male luer connector. For example, the connector may be a connector at the tip of a syringe or a connector connected to a stopcock or the like. Further, the configuration of the present embodiment can be adopted not only in a standard luer connector but also in any type of connector in which tapered surfaces are brought into contact with each other and connected. The male connector of the present embodiment is particularly useful for a connector forming a blood flow path. In some medical connectors, the shape of the connection recess may not be tapered, but in such a case, the soft surface of the male connector of the present disclosure is formed in a shape that matches the shape of the connection recess. Is preferred. In addition, although an example in which the side recess is a reduced diameter portion and the flexible portion is cylindrical has been described, the shape of the side recess is non-cylindrical (for example, a plurality of linear grooves extending in the axial direction), and the flexible portion is formed. May be non-cylindrical to fill the side recess.

  The male connector of the present disclosure is easy to connect and disconnect, has high liquid tightness, and is useful as a medical connector or the like.

Reference Signs List 100 male connector 100A male connector 110 connection convex portion 111 convex portion main body 111a reduced diameter portion 111b distal end surface 112 of reduced diameter portion flexible portion 121 hard surface 122 soft surface 123 base end surface 130 hub 140 tube connection portion 150 lock nut 151 screw Mountain 200 Female connector 210 Connection recess

Claims (6)

A connection projection having a tapered outer surface gradually increased in diameter from the distal end toward the proximal end side, which is inserted into the connection recess of the female connector,
The male connector, wherein the tapered outer surface has a hard surface provided at a distal end portion and a soft surface provided at a base end side of the hard surface.   The connection protrusion has a protrusion main body having a side surface recess, and a flexible portion formed of a material more flexible than the protrusion main body so as to fill the side surface recess, and constituting the soft surface. The male connector according to claim 1, wherein   The male connector according to claim 1, wherein a base end of the soft surface projects from the connection recess when the connection protrusion is inserted into the connection recess. A female connector has a connection projection having a tapered outer surface whose diameter is gradually increased from the distal end toward the proximal end,
The tapered outer surface has a soft surface,
A male connector, wherein the connection projection has a hard surface on a distal end side from a soft surface. Forming a connection projection inserted into the connection recess of the female connector,
The step of forming the connection convex portion includes forming a convex portion main body having a side surface concave portion at a position separated from the front end, and forming a flexible portion made of a material more flexible than the convex portion main body. Providing a tip surface and an inner surface in the side recess so that the tip surface and the inner surface are fixed to the tip surface and the outer surface of the side recess without a gap,
Manufacture of a male connector having a hard surface provided at a distal end portion and a soft surface provided more proximally than the hard surface, wherein the hard surface and the soft surface form an outer surface that is continuous. Method. The method for manufacturing a male connector according to claim 5, wherein the flexible portion is integrally formed with the side recess.

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