WO2014046271A1

WO2014046271A1 - Medical connector and method for manufacturing same

Info

Publication number: WO2014046271A1
Application number: PCT/JP2013/075590
Authority: WO
Inventors: 裕之中神; 辰也工藤; 慎吾阪本
Original assignee: 二プロ株式会社
Priority date: 2012-09-21
Filing date: 2013-09-20
Publication date: 2014-03-27
Also published as: JPWO2014046271A1; JP6678390B2; JP2019072648A

Abstract

Provided are: a medical connector having a novel structure, the medical connector being configured so that an elastic valve body does not come out of a housing; and a method for manufacturing the medical connector. A medical connector (36) is configured in such a manner that a disk-shaped elastic valve body (40) having a slit (92) formed in the center region (76) thereof so as to penetrate therethrough is mounted to a housing (38) which forms an opening portion of a fluid flow path. The slit (92) formed in the elastic valve body (40) comprises three or more cuts (94) extending radially from the center portion of the elastic valve body (40) toward the outer peripheral side.

Description

Medical connector and manufacturing method thereof

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.

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. For example, in a three-way cock and a Y-shaped connector, a fluid channel is formed between a pair of channel openings, and a medical connector is attached to the remaining one channel opening. And, by allowing a male connector such as a syringe to be connected to the fluid flow path via this medical connector, it is possible to perform mixed injection of a chemical solution or the like.

By the way, 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. .

In addition, 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. Thus, the male connector is connected to the fluid flow path in a communicating state.

However, in such a one-letter-shaped slit, the frictional resistance acting when the male connector is attached / detached is increased, and a large external force is exerted on the elastic valve body toward the fluid flow path, so that the elastic valve body may be detached from the housing. was there. In particular, when blood adheres to the surface of the elastic valve body and the friction coefficient of the surface of the elastic valve body increases, a greater force acts on the elastic valve body when the male connector is attached or detached, causing the elastic valve body to fall off. It was easy to become a problem.

JP-T-2-502976

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.

That is, 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.

According to the medical connector having the structure according to the first aspect as described above, when the male connector is inserted into the slit, the slit is configured by three or more incisions extending radially, thereby being easily opened. Thus, the frictional resistance acting between the male connector and the inner surface of the slit is reduced. Thereby, at the time of connection of a male connector, it can prevent that an elastic valve body falls out of a housing and enters into a fluid flow path.

According to a second aspect of the present invention, in the medical connector described in the first aspect, 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.

According to the second aspect, 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.

According to a third aspect of the present invention, in the medical connector described in the first or second aspect, 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.

According to the third aspect, by configuring the entire incision constituting the slit within a range that fits within the tip of the male luer, the elastic valve element can be brought into close contact with the male luer when the male luer is inserted. Thus, liquid-tightness can be ensured more stably.

According to a fourth aspect of the present invention, in the medical connector described in any one of the first to third aspects, 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. Thus, an 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. In addition, 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.

According to the fourth aspect, 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. As described above, 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.

According to a fifth aspect of the present invention, in the medical connector described in any one of the first to fourth aspects, a portion where the slit is formed in the elastic valve body has a flat plate shape.

According to the fifth aspect, since 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.

According to a sixth aspect of the present invention, in the medical valve described in any one of the first to fifth aspects, 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.

According to the sixth aspect, since 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.

According to a seventh aspect of the present invention, there is provided 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.

According to the manufacturing method of the medical connector according to the seventh aspect, 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. Thus, it is possible to easily form a cut that extends to the outer peripheral side as the outer peripheral end is inclined with respect to the axial direction and goes to the inner surface side.

According to the present invention, 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. Thus, 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.

The perspective view of the three-way cock provided with the medical connector (mixed injection port) as one Embodiment of this invention. The front view of the three-way cock shown in FIG. The perspective view of the co-injection port provided in the three-way cock shown in FIG. 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. The top view of the elastic valve body which comprises the mixed injection port shown by FIG. VII-VII sectional view of FIG. It is a model figure explaining the process of forming a slit in the elastic valve body shown by FIG. 6, Comprising: (a) is a state before cutting a cutter into an elastic valve body, (b) is an elastic valve. The state after being cut into the body shows the state after slit formation where (c) has pulled out the cutter from the elastic valve body. FIG. 9 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. The table | surface which shows the measured value of the radial direction dimension of the notch | incision formed in the elastic valve body shown by FIG. Sectional model for demonstrating the connection method of the luer lock connector with respect to the co-injection port shown by FIG. The table | 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.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

First, 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. In the following description, 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. As a result, 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. Has been. Further, 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. On the other hand, 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.

In the three-way cock 10 shown in FIGS. 1 and 2, 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. ing. 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. Furthermore, 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. By rotating the cock 14, 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.

Also, 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. FIG. As shown in FIG. 5, 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. Preferably, 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.

Further, 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. Further, 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. ing. In the small-diameter cylindrical portion 48, 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. Has been.

Further, on the outer peripheral surface of the small-diameter cylindrical portion 48, 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.

It should be noted that 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. When the male screw portion 64 is formed as in the present embodiment, 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.

Further, 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. . Further, 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.

As shown in FIGS. 6 and 7, 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). Thereby, when the opening locking piece 65 is overlapped on the upper side in the axial direction of the annular fixing portion 78, the outward protrusion of the opening locking piece 65 from the axial upper end surface of the center portion 76 is avoided.

Further,

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. Further, the 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.

Further, a concave groove 90 extending continuously over the entire circumference is formed inside the annular groove 84 on the inner surface 80. In short, the inner peripheral wall surface of the annular groove 84 is constituted by the concave groove portion 90. Further, 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.

Here, 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. In the present embodiment, the three

cuts

94a, 94b, and 94c are equally formed so as to form an equiangular shape in the circumferential direction. Is provided. Further, 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. Further, 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. Further, since 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.

Further, 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. In short, as shown in FIG. 7, 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 ). As is clear from this, 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. .

In particular, in the present embodiment, 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.

Next, 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. At this time, as shown in 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. Based on the above, 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. At that time, 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. As a result, as shown in FIG. 9C, the size of the cuts 94a to 94c is smaller at the outer surface 82 opening than at the inner surface 80 opening. In the present embodiment, 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.

Finally, as shown in FIG. 8C, 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 In this way, by inserting the cutter 100 into the central portion 76 of the elastic valve body 40 from 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. In the present embodiment, 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.

In addition, 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. However, it is also possible to form a three-way radial slit 92 by passing a single plate-like blade three times through the central portion 76 of the elastic valve body 40 at different circumferential angles.

Further, in the method of forming the elastic valve body 40 as described above, 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.

Further, in the method of forming the elastic valve body 40 as described above, 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.

However, such a method of forming the slit 92 in which the cutter 100 is cut from the inner surface 80 side while the central portion 76 of the elastic valve body 40 is curved and deformed is merely an example, and should be interpreted in a limited manner. is not. That is, in the cutter, not only the leading edge (the portion corresponding to the lower end of the cutter 100 shown in FIG. 8) but also the side edge (three-side radial outer end) is provided with a cutting edge, and the side edge is pivoted. The cross-sectional shape is inclined with respect to the direction and contracts toward the tip. And if this cutter is cut from the inner surface 80 with respect to the center part 76 of the elastic valve body 40, the slit 92 which expands toward the inner surface 80 will be formed accurately, without requiring the deformation | transformation of the center part 76. Can do. In addition, if the cutter is heated and used in advance, the deformation of the central portion 76 can be further suppressed.

Furthermore, for example, if a laser cutter is used, 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. As a result, in this embodiment, 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, and 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. That is, since the outer diameter of the male luer tip defined by ISO is 2.925 to 3.15 mm, the formed slit 92 is sized to fit within the male luer tip. As a result, when the male luer is inserted into the elastic valve body 40, 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. In addition, 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. Further, 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. In other words, 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. Thereby, 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.

Further, 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 | occurrence | production of the clearance gap between the protrusion front-end | tip part of the latching protrusion 56 and the groove bottom part of the annular groove 84 of the elastic valve body 40 is prevented.

Furthermore, 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. Further, 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.

Also, 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. Thereby, the front-end | tip part of the latching protrusion 74 is contact | abutted in the contact | adherence state without a clearance gap with respect to the inner surface of the bottom part of the annular groove 86 of the elastic valve body 40. FIG.

Further, since the opening locking piece 65 is disposed on the outer peripheral portion of the elastic valve body 40 away from the central portion 76, 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.

And the mixed injection port 36 which assembled | 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.

In this assembled state, 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. In the tubular mouth body 38, 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.

In addition, formation of the 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.

In the mixed injection port 36, 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. In the three-way cock 10 having such a structure, generally, the first branch opening 24 is connected to the tube on the upstream side of the infusion route, and the second branch opening 26 is connected to the tube on the downstream side. Thus, 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.

Then, as shown in FIG. 11, for example, 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, and 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. In the elastic valve body 40, the annular fixing portion 78 is locked by the locking projection 56 and the locking projection 74. Thereby, 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.

As a result, as shown in FIG. 11 (b), 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. At the same time, 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.

In the inserted state of the luer tip 112, 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. .

Therefore, in the mixed injection port 36 having the above-described structure, 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. As a result, when the luer tip 112 is inserted into the slit 92, 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. As a result, 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.

Further, since 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.

Further, 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.

Furthermore, 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. As a result, when the luer tip 112 is inserted and removed, the three cuts 94a to 94c constituting the slit 92 are opened and closed substantially uniformly, so that the stress is dispersed and the frictional resistance is reduced.

Further, 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.

In addition, it is estimated that 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. As a result, when hydraulic pressure acts on the inner surface 80, the portions located between the notches 94a to 94c in the circumferential direction are compressed and tightened to the virtual truncated cone surface side, so that the slit 92 is difficult to be opened. Conceivable.

Further, the improvement in pressure resistance by specifying the inclination direction of the outer peripheral ends of the cuts 94a to 94c has been confirmed by experiments as shown in FIG. In other words, in FIG. 12, 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. In each of the five elastic valve bodies (comparative examples), 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.

In the elastic valve body used in the experiment for obtaining the result shown in FIG. 12, in the incision 94 of the example, 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. On the other hand, in the incision of the comparative example, 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.

Further, in the mixed injection port 36, 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.

In addition, after the luer tip 112 has been removed, in the state where the elastic valve body 40 is elastically restored and the slit 92 is closed, 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.

In addition, 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. In addition, 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 | action of the stress and deformation | transformation in the elastic valve body 40 can be reduced.

Since the elastic valve body 40 is stretched and deformed by being pulled inward of the cylindrical mouth body 38 by frictional force when the luer tip 112 is inserted, as shown in FIG. In consideration, 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. .

Further, in the mixed injection port 36 of the present embodiment, when the luer tip 112 is inserted, 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.

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.

In FIG. 11, 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.

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, in the embodiment, 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. Specifically, like the elastic valve body 120 shown in FIG. 13, 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. By increasing the number of the cuts 94 in this way, the resistance when inserting and removing the luer tip 112 can be further reduced, and the elastic valve body 120 can be prevented from falling off from the cylindrical mouth body 38.

In addition, it is desirable that 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. In addition, it is desirable that the slits forming the slit are formed with uniform radial dimensions, but the slits may be formed with different radial dimensions. Furthermore, 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.

Further, 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. Furthermore, the outer peripheral end of the cut does not necessarily have to be inclined at a constant angle with respect to the axial direction. In addition, it is not essential that the outer peripheral end of the notch is inclined with respect to the axial direction, and may extend without being inclined with respect to the axial direction. In addition, it is desirable that the inclination direction of the outer peripheral edge of the cut gradually inclines toward the outer peripheral side toward the inner surface 80 as in the above-described embodiment, but may be in the opposite direction.

Further, 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. In the present invention, the radial width dimension and depth dimension of the recessed groove portion 90 are not limitedly interpreted.

In the above embodiment, 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. In the embodiment, a valve seat may be directly formed in the opening portion of the third branch pipe 22 in the holder 12.

Moreover, in the said embodiment, although the application example to the three-way stopcock of the medical connector according to this invention was shown, this invention is with respect to the medical connector employ | adopted as various conventionally well-known medical fluid flow paths. Applicable. For example, as shown in FIGS. 14A and 14B, the present invention can also be applied to the plug 130 and the T-shaped mixed injection tube 140.

10: Three-way stopcock, 36: Mixed injection port (medical connector), 38: Cylindrical mouth (housing), 40, 120: Elastic valve body, 54: Annular seat (valve seat), 56: Locking projection , 65: Opening locking piece, 74: Locking protrusion, 78: Ring fixing portion, 84: Ring groove, 86: Ring groove, 88: Constricted portion, 92: Slit, 94: Cutting, 100: Cutter, 130 : Plug, 140: T-shaped mixed injection tube

Claims

A medical connector in which a disc-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,
The medical connector, wherein the slit of the elastic valve body is constituted by three or more cuts extending radially from a central portion of the elastic valve body toward an outer peripheral side.
The medical connector according to claim 1, wherein a length of the cut in the inner surface of the elastic valve body is larger than a length of the cut in an outer surface of the elastic valve body.
3. The medical connector according to claim 1 or 2, wherein an entire outer surface of the elastic valve body is provided in a range in which the entire cut forming the slit is accommodated in a distal end portion of a male luer inserted into the slit.
By forming annular grooves extending in the circumferential direction on both the inner and outer surfaces of the outer peripheral portion of the elastic valve body, an annular constricted portion is provided, and the outer peripheral side of the elastic valve body is an annular fixed portion. On the other hand, a valve seat is formed so as to protrude to the inner peripheral side of the housing, and an opening locking piece is provided in the housing, and the inside of the valve receiving seat and the opening locking piece is provided. 4. A locking projection is formed on the peripheral edge, and the locking projection is locked in the annular groove formed on both the inner and outer surfaces of the elastic valve body. The medical connector as described in.
The medical connector according to any one of claims 1 to 4, wherein a portion where the slit is formed in the elastic valve body has a flat plate shape.
The slit is constituted by the three incisions provided so as to be equiangular in the circumferential direction,
The medical connector according to any one of claims 1 to 5, wherein the radial dimension of each of the cuts is substantially equal.
A method of manufacturing a medical connector 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, and is mounted.
Pressing the cutting blade of the cutter against the molded elastic valve body from the inner surface side, and subsequently forming the slit formed by three or more radially extending cuts in the elastic valve body. A method of manufacturing a medical connector characterized by the above.