JP2016000134A - Liquid pouring connector, and manufacturing method for the connector - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a liquid pouring connector capable of being manufactured by an easier method, and a method for manufacturing the connector.SOLUTION: A detention needle connector 5 as a liquid pouring connector comprises: a body 51 having an internal space 52; and a seal member 53 for sealing the internal space 52 of the body 51 thereby to insert a needle tube. When the detection needle connector 5 is manufactured, the body 51 is formed by a plastic resin injection molding, and the seal member 53 is molded by an insert molding using a liquid silicone rubber self-adhesive material.

Description

  The present invention relates to a medical infusion connector used for an indwelling needle, an infusion circuit, a blood circuit, and the like, and a method for manufacturing the same.

  Conventionally, an indwelling needle has been used to administer a drug solution or the like to a blood vessel of a patient. The indwelling needle is configured to include a catheter hub and a hollow catheter that is attached to the catheter hub and placed in a patient's blood vessel (see, for example, Patent Document 1). In use, the inner needle is inserted into the catheter, and the catheter is punctured into the blood vessel together with the inner needle. Next, the catheter is placed in the blood vessel by withdrawing the inner needle from the blood vessel. At this time, in order to prevent the patient's blood from overflowing through the catheter, an indwelling needle connector having a sealing member as a hemostasis valve is attached to the catheter hub.

  A conventional indwelling needle connector has been manufactured, for example, as follows. Referring to FIG. 9, first, a sealing member 200 made of isoprene rubber or silicone rubber is inserted into the main body 100 (FIG. 9A), and the thin portion 201 of the sealing member 200 is folded outward (FIG. 9B). ). Next, the outer tube 300 covers the folded portion of the seal member 200 (FIG. 9C) and heat treatment is performed. Then, the outer tube 300 is thermally contracted, and the seal member 200 is held so as not to be detached from the main body 100 (FIG. 9D), and the indwelling needle connector 400 as described above is completed.

  In addition, a port connector is provided in a blood circuit or an infusion circuit used for dialysis, infusion, etc., and a drug solution or the like is mixedly injected into blood (infusion) flowing through the blood circuit (infusion circuit) via this port connector and administered to a patient. (For example, see Patent Document 2). This port connector includes a main body having a port and a seal member that seals the port, and a needle tube is punctured into the seal member when a chemical solution or the like is mixedly injected. Such a port connector has been manufactured by inserting a seal member made of isoprene rubber or silicone rubber into a port of the main body, and covering the cap to fix the seal member to the main body.

JP 2014-68713 A JP 2009-101093 A

  The conventional methods for manufacturing indwelling needle connectors and port connectors described above have a problem in that the number of parts and manufacturing processes are large, and the manufacturing cost increases. In addition, the dimensional management of the main body and the seal member is strict, and there is a limit to the miniaturization. Further, the sealing member made of isoprene rubber has a problem that the durability against needle sticking is not sufficient. In the method for manufacturing the indwelling needle connector, it takes time and effort to fold back the thin portion of the seal member.

  An object of this invention is to provide the connector for liquid injection which can be manufactured by a simpler method, and its manufacturing method.

  The manufacturing method according to claim 1 of the present invention is a manufacturing method of a connector for pouring provided with a seal member through which a needle tube is pierced, wherein a plastic resin injection molding is performed using a first mold mechanism, and a hollow A main body forming step for forming a main body having a portion; insert molding by setting the main body in a second mold mechanism and pouring liquid silicone rubber into a cavity defined by the main body and the second mold mechanism And a sealing member forming step of forming a sealing member for sealing the hollow portion.

  In the manufacturing method according to claim 2 of the present invention, the liquid silicone rubber is a liquid silicone rubber self-adhesive material, and the sealing member is bonded to the main body by the self-adhesiveness of the liquid silicone rubber self-adhesive material, It is integrated with the main body.

  In the manufacturing method according to claim 3 of the present invention, the main body forming step includes an injection molding step of forming a main body intermediate body having a hollow portion by plastic resin injection molding using the first mold mechanism. Forming an unevenness on the inner surface of the hollow portion to form the main body, and the sealing member is formed on the inner surface of the hollow portion on which the unevenness is formed.

  The liquid injection connector according to claim 4 of the present invention is a liquid injection connector comprising a main body having a hollow portion, and a seal member for sealing the hollow portion and allowing the needle tube to pass therethrough, It manufactures by the manufacturing method in any one of Claims 1-3.

  The liquid injection connector according to claim 5 of the present invention is characterized in that a concave portion for guiding the needle tube to a central portion in the radial direction of the seal member is provided on an outer surface of the seal member. .

  The indwelling needle according to claim 6 of the present invention is inserted through the catheter, a catheter hub attached to the proximal end portion of the catheter, a connector attached to the proximal end side of the catheter hub, and the catheter. An indwelling needle comprising an inner needle, wherein the connector is the connector for liquid injection according to claim 4 or 5.

  According to the manufacturing method of the liquid injection connector according to the first aspect of the present invention, the main body formed by the main body forming step is set in the second mold mechanism, the liquid silicone rubber is poured into the insert molding, and the sealing is performed. Since the member is formed, the liquid injection connector can be easily manufactured as compared with the conventional method in which the separately formed main body and the sealing member are combined later. In addition, since the seal member is formed of silicone rubber, it is possible to provide a liquid injection connector that is superior in durability compared to a conventional isoprene rubber seal member.

  According to the method for manufacturing a connector for liquid injection according to claim 2 of the present invention, since the sealing member is formed of a liquid silicone rubber self-adhesive material, the sealing member is formed by the self-adhesiveness of the liquid silicone rubber self-adhesive material. A fixing member that is bonded to the main body and fixes the seal member to the main body becomes unnecessary, and the number of parts and the manufacturing process can be reduced.

  According to the method for manufacturing a connector for injecting liquid according to claim 3 of the present invention, since the seal member is formed on the inner surface of the hollow portion having the irregularities, the seal member is fixed to the main body by the anchor effect of the irregularities. The fixing member for fixing the seal member to the main body is not necessary, and the number of parts and the manufacturing process can be reduced.

  According to the liquid injection connector of the fourth aspect of the present invention, since it is manufactured by the manufacturing method according to any one of the first to third aspects, the same effect as described above can be obtained.

  According to the liquid injection connector of the fifth aspect of the present invention, since the concave portion is provided on the outer surface of the seal member, the needle tube can be guided to the central portion in the radial direction of the seal member. It can be easily inserted through the central portion of the seal member.

  Since the indwelling needle according to claim 5 of the present invention includes the liquid injection connector according to claim 4 or 5, the same effect as described above can be obtained.

It is a figure which shows the indwelling needle provided with the connector for liquid injection which concerns on 1st Embodiment of this invention, Comprising: (a) is a top view which shows the disassembled state, (b) is a top view which shows the combined state. II-II sectional view taken on the line of FIG. It is a figure explaining the manufacturing process of the connector for liquid injection shown in FIG. 1, Comprising: (a) is a figure explaining a main body formation process, (b) is a figure explaining a sealing member shaping | molding process. Sectional drawing which shows the connector for liquid injection which concerns on 2nd Embodiment of this invention. The schematic diagram of an infusion set provided with the connector for liquid injection which concerns on 3rd Embodiment of this invention. Sectional drawing of the connector for liquid injection shown in FIG. The figure explaining the main body formation process of the manufacturing process of the connector for liquid injection shown in FIG. The figure explaining the sealing member molding process of the manufacturing process of the connector for liquid injection shown in FIG. The figure explaining the conventional catheter hub manufacturing process.

[First Embodiment]
Hereinafter, with reference to an accompanying drawing, a connector for liquid injection concerning a 1st embodiment of the present invention and a manufacturing method for the same are explained. Here, an indwelling needle connector provided in the indwelling needle will be described as an example of the liquid injection connector. First, the whole structure of an indwelling needle provided with the liquid injection connector which concerns on this embodiment is demonstrated easily.

  An indwelling needle 1 shown in FIG. 1 includes an indwelling portion 2 and a puncture needle 6. The indwelling portion 2 includes a catheter 3 as an outer needle, a catheter hub 4 fixed to the proximal end portion of the catheter 3, and an indwelling needle connector (fluid connector) 5. The inner needle 61 is inserted through the indwelling portion 2, and the inner needle hub 62 is fixed to the proximal end portion of the inner needle 61.

  Referring also to FIG. 2, the catheter 3 is configured in a thin tube having a predetermined length, and the catheter hub 4 is configured in a substantially cylindrical shape. The indwelling needle connector 5 has a substantially cylindrical main body 51 and a seal member 53 as a hemostasis valve formed integrally with the main body 51. The inner space (hollow part) 52 of the main body 51 has a proximal end portion formed with a diameter slightly larger than that of the distal end portion, and constitutes an enlarged diameter portion 52a. The seal member 53 is made of silicone rubber, and is provided in the enlarged diameter portion 52 a of the main body 51 to seal the internal space 52 of the main body 51. Further, a conical base end side recess 53 b is formed on the base end surface of the seal member 53.

  The inner needle 61 of the puncture needle 6 is formed of a thin tubular needle tube, and the tip end portion 61 a is formed by a sharpened portion formed to be inclined with respect to the axial direction of the inner needle 61. The inner needle 61 is inserted from the rear end portion of the indwelling portion 2 so as to pass through the seal member 53, and the distal end portion 61a protrudes outside from the distal end opening of the catheter 3 (the state shown in FIG. 1B). ). Here, when the inner needle 61 is inserted through the seal member 53, the tip end portion 61a of the inner needle 61 is guided to the radial center of the seal member 53 by the rear end side recess 53b of the seal member 53, and the seal member The central part of 53 can be inserted. The inner needle hub 62 functions as a grip for holding the puncture needle 6.

  Here, the angle θ of the side surface of the proximal-side concave portion 53b with respect to the surface P orthogonal to the axial direction D of the indwelling needle connector 5 is preferably about 5 ° to 60 °, and about 15 ° to 30 °. Is more preferable. This is because if the angle θ is too small, it is difficult to guide the distal end portion 61a of the inner needle 61 to the central portion, and if the angle θ is too large, the sealing performance by the seal member 53 may be impaired.

  The indwelling needle 1 having such a configuration is used as follows. First, as shown in FIG. 1B, with the puncture needle 6 set in the indwelling portion 2, the distal end portion of the catheter 3 is punctured into the patient's arm or the like together with the distal end portion 61a of the inner needle 61 to reach the blood vessel. To reach. Next, the puncture needle 6 (inner needle 61) is withdrawn from the indwelling part 2 while the indwelling part 2 remains in the patient's blood vessel. When the indwelling portion 2 is placed in the blood vessel in this way, the blood vessel flows into the internal space 52 of the indwelling needle connector 5 through the catheter 3 and the catheter hub 4, but the internal space 52 of the indwelling needle connector 5 is sealed. Since the liquid is closed by the member 53, the blood does not overflow to the outside. That is, the seal member 53 is formed integrally with the main body 51, and blood does not leak between the seal member 53 and the main body 51. Further, when the inner needle 61 is inserted into the seal member 53, a through hole is formed in the seal member 53. However, after the inner needle 61 is extracted from the seal member 53, the through hole is formed in the seal member 53 itself. The blood is not leaked from the through hole.

  And the needle tube (not shown) provided in the front-end | tip of the injection needle (needle tube) of a syringe and the tube extended from an infusion bag is penetrated in the sealing member 53 of the indwelling part 2 indwelled in this way. A liquid such as a medicinal solution stored in a syringe or a liquid bag can be injected (poured) into the patient via the indwelling unit 2.

  Next, a manufacturing method of the indwelling needle connector 5 (liquid injection connector) will be described. Referring to FIG. 3A, first, the first mold M11 and the second mold M12 included in the first mold mechanism M1 are clamped, and the first mold M11 and the second mold M12 are fixed. A thermoplastic resin (more specifically, a polycarbonate resin) is injected into the first cavity C1 defined in between. The shape of the first cavity C1 matches the shape of the main body 51 of the indwelling needle connector 5. Thereby, the thermoplastic resin is filled in the first cavity C1, and the main body 51 as the primary molded product is formed (main body forming step).

  Next, referring to FIG. 3 (b), the main body 51 obtained by the main body forming step described above is set in a third mold M21 provided in the second mold mechanism M2, and the third mold M21 and The fourth mold M22 is clamped. In this way, the liquid silicone rubber self-adhesive material is injected into the second cavity C2 defined in the second mold mechanism M2 in which the main body 51 is set. The shape of the second cavity C2 matches the shape of the seal member 53. Thereby, the liquid silicone rubber self-adhesive material is filled in the second cavity C2 to form the seal member 53 (hemostatic valve). At this time, the seal member 53 is bonded to the main body 51 by the self-adhesiveness of the liquid silicone rubber self-adhesive material, and the indwelling needle connector 5 in which the seal member 53 and the main body 51 are integrally formed is completed (sealing member molding). Process).

  As described above, according to the method for manufacturing a liquid injection connector according to the present embodiment, the seal member 53 is integrally formed with the main body 51 by insert molding. Therefore, the seal member 53 and the main body 51 are separately formed. Compared with the conventional method of assembling, the connector for liquid injection can be manufactured more easily, and it can respond to a smaller connector for liquid injection. Moreover, since the sealing member 53 and the main body 51 are bonded by the self-adhesive force of the silicone resin, no gap is generated between the sealing member 53 and the main body 51, and the hemostatic effect can be more reliably ensured. Furthermore, the seal member 53 is not accidentally dropped from the main body 51 without using a separate fixing member.

[Second Embodiment]
Next, a connector for liquid injection and a method for manufacturing the same according to a second embodiment of the present invention will be described. Also in the present embodiment, the indwelling needle connector provided in the indwelling needle will be described as an example of the liquid injection connector. Referring to FIG. 4, the indwelling needle connector 5A according to the present embodiment has substantially the same configuration as the indwelling needle connector 5 described above, but the inner peripheral surface of the main body 51A provided in the indwelling needle connector 5A is The difference is that unevenness is formed.

  Such an indwelling needle connector 5A is manufactured as follows. First, a main body intermediate (not shown) is formed using the first mold mechanism M1 by the same method as the main body forming step in the first embodiment described above (injection molding step). Since this main body intermediate body has the same shape as the main body 51 according to the first embodiment described above, description thereof will be omitted. Next, fine unevenness is formed on the inner surface of the main body intermediate (irregularity forming step) to complete the main body 51A. A portion where the irregularities are formed is an inner peripheral surface of the enlarged diameter portion 52 a and is a portion integrated with the seal member 53. As a method for forming the irregularities, for example, there is a method of forming fine concave portions by performing discharge treatment or flame quenching treatment on the inner peripheral surface of the main body intermediate body, but the formation method is not limited.

  And by the same method as the sealing member molding step in the first embodiment, insert molding using the second mold mechanism M2 is performed, so that the sealing member 53 is integrally formed on the main body 51A. The connector (indwelling needle connector 5A) is completed.

  As described above, by performing insert molding using the main body 51A having the inner peripheral surface formed with the irregularities, the sealing member 53 falls off from the main body 51A due to the uneven anchor effect formed on the inner peripheral surface of the main body 51A. Can be prevented more reliably. That is, the inner peripheral surface of the main body 51A on which these irregularities are formed is substantially parallel to the removal direction D1 of the seal member 53, and these irregularities have a depth / height in a direction intersecting the removal direction D1. Therefore, even if a force in the removal direction D1 acts on the seal member 53, the seal member 53 does not move in the removal direction D1 with respect to the main body 51A, and does not come off the main body 51A.

  In the present embodiment, as the silicone rubber material for molding the seal member 53, a silicone rubber material that does not have self-adhesion can be used in place of the above-described one that has self-adhesion. This is because even if the main body 51A and the seal member 53 are not bonded, the seal member 53 can be prevented from falling off due to the uneven anchor effect formed in the main body 51A.

[Third Embodiment]
In 1st and 2nd embodiment mentioned above, although the case of the indwelling needle connector with which an indwelling needle is provided as a liquid injection connector was demonstrated to the example, the manufacturing method which concerns on this invention is another liquid injection connector, for example, The present invention can also be applied to port connectors provided in infusion circuits and blood circuits. Hereinafter, a port connector will be described as an example of a liquid throwing connector. Here, first, the entire structure of an infusion set including a port connector as a liquid injection connector will be briefly described.

  An infusion set 7 shown in FIG. 5 includes an indwelling needle 30 placed in the patient's blood vessel V, an infusion circuit 8 connected to the proximal end of the indwelling needle 30, and an infusion connected to the proximal end of the infusion circuit 8. The infusion circuit 8 includes a first infusion tube 81 connected to the infusion bag 9, a second infusion tube 82 connected to the indwelling needle 30, a first infusion tube 81, and a first infusion tube 81. Port connector 10 (injection connector) for connecting the two infusion tubes 82. A predetermined infusion solution is stored in the infusion bag 9, and this infusion solution is administered to the patient via the first infusion tube 81, the port connector 10, the second infusion tube 82, and the indwelling needle 30. The port connector 10 has a first port 13, and through this first port 13, for example, liquid stored in a syringe or a liquid medicine bag (liquid bag 21 in the example of FIG. 5) is mixedly injected into the infusion solution. Can be administered to patients.

  Next, a specific configuration of the port connector 10 will be described. Referring to FIG. 6, the port connector 10 includes a main body 11 and a seal member 14 formed integrally with the main body 11. The main body 11 has a cylindrical portion 12 formed in a substantially cylindrical shape and a first port (branch pipe) 13 branched from the cylindrical portion 12, and is formed to have a T-shape as a whole. The cylindrical portion 12 includes a cylindrical second port 12a to which the first infusion tube 81 is connected, a cylindrical third port 12b to which the second infusion tube 82 is connected, and a second port 12a. And a cylindrical connection portion 12c that connects the third port 12b to form a main route through which the infusion solution flows. The inner diameter of the second port 12a and the inner diameter of the third port 12b are substantially the same, and the inner diameter of the connecting portion 12c is smaller than the inner diameters of the second and third ports 12a and 12b. The first port 13 is provided so as to protrude from the connection portion 12 c in a direction perpendicular to the longitudinal direction of the cylindrical portion 12. In addition, an opening 12d communicating with the first port 13 is provided on the side wall of the connection portion 12c.

  The seal member 14 is made of silicone rubber, and seals the first port 13 and the opening 12d of the connection portion 12c. More specifically, the seal member 14 includes a main body portion 14a provided inside the first port 13 and a projecting portion 14b that projects from the main body portion 14a and is provided in the opening 12d. A conical recess 14c is provided on the outer surface of the main body 14a. The angle θ1 of the side surface of the recess 14c with respect to the surface P1 orthogonal to the axial direction D2 of the first port 13 is preferably about 5 ° to 60 °, and about 15 ° to 30 °, as with the angle θ described above. It is more preferable that

  In such a configuration, the infusion supplied from the infusion bag 9 to the port connector 10 via the first infusion tube 81 passes through the main route including the second port 12a, the connection portion 12c, and the third port 12b. It is supplied to the second infusion tube 82 and administered to the patient via the indwelling needle 30. Further, when a liquid such as a chemical solution stored in the liquid bag 21 is administered, a needle tube 23 provided at the tip of a tube 22 extending from the liquid bag 21 is pierced (punctured) into the seal member 14 of the port connector 10. . Thereby, the liquid bag 21 and the port connector 10 are connected, and the liquid stored in the liquid bag 21 can be mixed and injected into the infusion solution from the infusion bag 9 to be administered (dispensed) to the patient.

  A method of manufacturing the port connector 10 (liquid injection connector) configured as described above will be described. First, referring to FIG. 7A, at the same time as closing the pair of upper and lower molds M31 and M32 provided in the first mold mechanism M3, the pair of left and right slide molds M33 and M34 are moved in the directions of arrows A1 and A2. To connect to. As a result, as shown in FIG. 7B, in the first mold machine M3, a first cavity C3 is defined by a plurality of molds M31 to M34. A thermoplastic resin (more specifically, a polycarbonate resin) is injected into the first cavity C3. The shape of the first cavity C3 matches the shape of the main body 11 of the port connector 10. Thereby, the thermoplastic resin is filled in the first cavity C3, and the main body 11 as the primary molded product is formed (main body forming step).

  Next, referring to FIG. 8A, the main body 11 as the primary molded product is set at a predetermined position of the second mold mechanism M4. Next, the slide mold M41 and the upper mold 42 are operated, the pin portion M41a of the slide mold M41 is inserted into the cylindrical portion 12 of the main body 11, and the opening 12d is closed from the inside of the cylindrical portion 12, The first port 13 of the main body 11 is accommodated in the recess R1 of the upper mold M42. As a result, a second cavity C4 is defined in the second mold mechanism M4 by the main body 11, the slide mold M41, and the upper mold M42, and a liquid silicone rubber self-adhesive material is injected into the second cavity C4. The shape of the second cavity C4 matches the shape of the seal member 14. Thereby, the liquid silicone rubber self-adhesive material is filled in the second cavity C4 to form the seal member 14, and the port connector 10 in which the seal member 11 and the main body 14 are integrally formed is completed (sealing member molding step). ). Therefore, also in this embodiment, the same effect as described above can be obtained.

  As mentioned above, although the connector for liquid injection which concerns on embodiment of this invention and its manufacturing method were demonstrated with reference to attached drawing, this invention is not limited to this embodiment, Various without deviating from the scope of the present invention. The deformation | transformation thru | or correction | amendment are possible.

  For example, in the third embodiment described above, the port connector used in the infusion circuit has been described as an example, but such a port connector can also be used in a blood circuit for dialysis, for example.

  In the case of the connector for liquid injection according to the third embodiment described above, as in the second embodiment described above, the inner peripheral surface of the main body 11 and a portion integrated with the seal member 14 (that is, the first Irregularities may be formed on the inner peripheral surface of the 1 port 13, and in this case, a liquid silicone rubber material having no self-adhesiveness can be used as the material of the seal member 14.

DESCRIPTION OF SYMBOLS 1 Indwelling needle 2 Indwelling part 3 Catheter 4 Catheter hub 5,5A Indwelling needle connector (connecting connector)
6 Puncture needle 7 Infusion set 8 Infusion circuit 10 Port connector (injection connector)
14, 53 Seal member 51, 51A body

Claims (6)

A method for producing a connector for liquid injection comprising a seal member through which a needle tube is penetrated,
A main body forming step of performing plastic resin injection molding using the first mold mechanism and forming a main body having a hollow portion;
The hollow body is sealed by setting the main body in a second mold mechanism and pouring liquid silicone rubber into a cavity defined by the main body and the second mold mechanism to perform insert molding. And a sealing member molding step for molding the sealing member.   The liquid silicone rubber is a liquid silicone rubber self-adhesive material, and the sealing member is bonded to the main body by the self-adhesive property of the liquid silicone rubber self-adhesive material, and is integrated with the main body. Item 2. A method for manufacturing a liquid injection connector according to Item 1. The main body forming step includes an injection molding step of forming a main body intermediate body having a hollow portion by plastic resin injection molding using the first mold mechanism, and forming an unevenness on the inner surface of the hollow portion to form the main body. Including an unevenness forming step for forming,
The method for manufacturing a liquid injection connector according to claim 1, wherein the seal member is formed on an inner surface of the hollow portion in which the unevenness is formed.   It is a connector for liquid injection provided with the main body which has a hollow part, and the sealing member for sealing the said hollow part and inserting a needle tube, Comprising: It manufactures with the manufacturing method in any one of Claims 1-3. A connector for pouring, which is characterized by the above.   5. The liquid injection connector according to claim 4, wherein a concave portion for guiding the needle tube to a radially central portion of the seal member is provided on an outer surface of the seal member. An indwelling needle comprising a catheter, a catheter hub attached to a proximal end portion of the catheter, a connector attached to a proximal end side of the catheter hub, and an inner needle inserted through the catheter, An indwelling needle characterized in that the connector is the connector for liquid injection according to claim 4 or 5.

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