JP2019115405A - Medical instrument, intermediate molding of connection port member constituting medical instrument, and manufacturing method of medical instrument - Google Patents

Abstract

To provide a medical instrument, an intermediate molding of a connection port member constituting the medical instrument, and a manufacturing method of the medical instrument capable of improving durability.SOLUTION: A medical instrument includes a first annular part 27 made of a first material, and a second annular part 28 made of a second material softer than the first material, which is formed integrally on an inner peripheral surface 41 of the first annular part 27, and forms a connection port 8 that can fit with a connection object. An intermediate molding includes an anchor part 30. A manufacturing method of the medical instrument includes a formation process and an assembly process. The formation process includes an intermediate molding formation process for forming the intermediate molding having the first annular part 27 with the inner peripheral surface 41, and an injection process for forming the second annular part 28 on the inner peripheral surface 41 of the intermediate molding by injection molding.SELECTED DRAWING: Figure 5

Description

  The present disclosure relates to a medical device, an intermediate formed body of a connection port member that constitutes the medical device, and a method of manufacturing a medical device.

  A medical connector for forming an infusion line or the like may have a connection port to which male connector portions of other medical connectors are connected by fitting. Such connection ports include a closed type in which a valve body is disposed (see, for example, Patent Document 1) and an open type in which a valve body is not disposed. Moreover, as medical instruments other than a medical connector, for example, a syringe may have a piston member, a syringe member, and a needle member. And a syringe member may have a connection port where a needle member is connected by fitting.

Patent No. 3389983

  The connection port as described above is required to have good durability against breakage or the like caused by an external force from the connection object or the like fitted to the connection port. However, when the connection port member forming the connection port is formed of a relatively soft material in order to obtain chemical resistance performance and good connectivity, the durability may be impaired.

  In view of such a point, the present disclosure provides a medical device, an intermediate formed body of a connection port member constituting the medical device, and a method of manufacturing the medical device, which can improve durability. To aim.

The medical device according to the first aspect of the present invention is
A first annular portion made of a first material;
A second annular portion made of a second material that is softer than the first material and integrally formed on the inner circumferential surface of the first annular portion to form a connection port that can be fitted with a connection object;
Have.

In one embodiment of the invention:
The first material comprises a fibrous filler,
The second material does not contain a fibrous filler.

In one embodiment of the invention:
The first material comprises a first concentration of fibrous filler,
The second material comprises the fibrous filler of a second concentration lower than the first concentration.

  As one embodiment of the present invention, the first annular portion has an anchor portion which has a convex shape over the entire circumference at a boundary surface with the second annular portion.

In one embodiment of the invention:
The medical device is
A cap member having the first annular portion and the second annular portion;
A valve member disposed at the connection port of the second annular portion;
A medical connector having

  The intermediate molded body of the connection port member constituting the medical device according to the second aspect of the present invention has an anchor portion which has a convex shape over the entire circumference on the inner peripheral surface.

According to a third aspect of the present invention, there is provided a method of manufacturing a medical device,
A forming step of forming a connection port member that forms a connection port that can be mated with a connection object;
An assembly step of assembling a medical instrument using the connection port member;
Have
The forming step is
An intermediate formed body forming step of forming an intermediate formed body having a first annular portion having an inner circumferential surface;
And an injection step of forming a second annular portion on the inner circumferential surface of the intermediate molded body by injection molding.

In one embodiment of the invention:
The forming step is
First injection molding to obtain a primary intermediate molded body having the first annular portion having the inner circumferential surface and the central gate portion connected to the inner circumferential surface over the entire circumference by injection molding of the first material Process,
Cutting the central gate portion from the first annular portion of the primary intermediate molded body to obtain a secondary intermediate molded body;
A second injection step of forming the second annular portion covering the cut surface of the central gate portion of the secondary intermediate formed body by injection molding of the first material or a second material different from the first material; Have.

In one embodiment of the invention:
In the cutting step, the central gate portion is cut and removed from the first annular portion of the primary molded body leaving a part of the central gate portion, whereby the inner circumferential surface of the first annular portion is formed. A convex anchor portion is formed over the entire circumference.

  According to the present disclosure, it is possible to provide a medical device, an intermediate molded body of a connection port member constituting the medical device, and a method of manufacturing a medical device, which can improve durability.

It is a perspective view showing the medical instrument concerning one embodiment of the present invention. It is a disassembled perspective view of the medical instrument shown in FIG. It is a top view of the medical instrument shown in FIG. It is AA sectional drawing of FIG. It is the elements on larger scale of FIG. It is a perspective view which shows typically the other example of the medical instrument shown in FIG. It is a flowchart which shows the manufacturing process in the manufacturing method of the medical device which concerns on one Embodiment of this invention. It is sectional drawing which shows the primary intermediate molded object obtained by the 1st injection process shown in FIG. It is sectional drawing which shows the mode of the cutting process shown in FIG.

  Hereinafter, with reference to the drawings, a medical device, an intermediate molded body of a connection port member constituting the medical device, and a method of manufacturing a medical device according to an embodiment of the present invention will be described in detail. In the present specification, the vertical direction means the direction along the central axis of the connection port, the upper side means the direction from the inside to the outside of the connection port, and the lower side means the opposite direction. That is, the upper side is the upper side in FIG. 4, and the lower side is the lower side in FIG. In the present specification, the longitudinal cross section means a cross section including the central axis of the connection port.

  First, a medical instrument according to an embodiment of the present invention will be illustrated and described in detail with reference to FIGS. As shown in FIGS. 1 to 4, the medical device 1 according to the present embodiment is configured as a medical connector having a cap member 2, a valve member 3, a valve support member 4 and a holder 5. . The medical instrument 1 has a closed female connector portion 6 constituted by a cap member 2, a valve member 3 and a valve support member 4. Further, the medical instrument 1 has an open male connector portion 7 constituted by the holder 5. In the present embodiment, the medical device 1 is configured as an I-type connector having only two connector portions arranged concentrically with each other.

  The cap member 2 has a connection port 8 which can be fitted with a male luer as a connection object. The connection port 8 is formed by the inner peripheral surface of the annular top wall 2 a having the central axis O. The cap member 2 has a top wall 2a, a cylindrical outer peripheral wall 2b depending from the outer peripheral edge of the top wall 2a, and an annular upper flange 2c extending radially outward from the lower end of the outer peripheral wall 2b. A pair of projecting pieces 2d extending radially outward from two locations opposing each other across the central axis O on the outer peripheral edge of the upper flange 2c. The number of protrusions 2d can be changed as appropriate. The protrusion 2d may not be provided. On the outer peripheral surface of the outer peripheral wall 2b, a male screw 9 which enables a luer lock is provided. In the present embodiment, the male screw 9 is a double thread screw. However, the shape of the male screw 9 can be changed as appropriate. Instead of the male screw 9, a shape engaging portion other than a screw, which can be in shape engagement to hold the male luer, may be provided. The shape engaging portion may not be provided.

  As shown in FIG. 4 and FIG. 5, the connection port 8 has a constant inner diameter (for example, 4.15 mm) in the axial direction in the present embodiment. However, the shape of the connection port 8 can be changed as appropriate. For example, the connection port 8 may be tapered downward in diameter. An upper annular convex portion 10 having a cylindrical shape centering on the central axis O is provided on the bottom surface of the top wall 2a. The upper annular convex portion 10 has an annular lower end surface 10a. Between the lower end surface 10 a and the connection port 8, an annular chamfered portion 11 having a linear shape in the vertical cross section is provided. Between the lower end surface 10 a of the upper annular convex portion 10 and the outer peripheral surface 10 b of the upper annular convex portion 10, an annular chamfered portion 12 having an arc shape in a longitudinal cross section is provided. However, the shape of the upper annular convex portion 10 can be changed as appropriate. The outer circumferential surface 10b of the upper annular convex portion 10, the portion radially outward of the upper annular convex portion 10 at the bottom of the ceiling wall 2a, and the outer circumferential surface 10b of the upper annular convex portion 10 at the inner circumferential surface of the outer circumferential wall 2b The upper support recess 13 having an annular shape is formed by the portion to be formed.

  As shown in FIGS. 2 and 4, the valve support member 4 extends radially outward from the lower end of the inner peripheral wall 4a fitted to the inner peripheral surface of the outer peripheral wall 2b of the cap member 2 and the lower end of the inner peripheral wall 4a. And an annular lower flange 4b in contact with the bottom surface of the upper flange 2c of the cap member 2. The upper flange 2c and the lower flange 4b are joined together, for example, by welding.

  As shown in FIGS. 4 and 5, on the top surface of the inner circumferential wall 4a, a lower annular convex portion 14 having a cylindrical shape centering on the central axis O is provided. The lower annular convex portion 14 has a ring-shaped upper end surface 14a that has a semicircular arc shape in the longitudinal cross section. However, the shape of the upper end face of the lower annular convex portion 14 can be changed as appropriate. The outer circumferential surface 14b of the lower annular projection 14, the portion of the top surface of the inner circumferential wall 4a radially outward of the lower annular projection 14, and the inner circumferential surface of the outer circumferential wall 2b of the cap member 2 The lower support recess 15 having an annular shape is formed by the portion facing the outer peripheral surface 14 b. The valve support member 4 can be obtained, for example, by injection molding using a synthetic resin as a material.

  As shown in FIGS. 2 and 4, the valve member 3 is disposed at the connection port 8. The valve member 3 has a cylindrical valve body 3a capable of closing the connection port 8, and an annular valve support 3b extending radially outward from the outer peripheral surface of the valve body 3a. doing. The valve body 3 a has a slit 16 which is pushed and opened by the male luer by fitting the male luer to the connection port 8. In the present embodiment, the slit 16 has a one-letter shape in top view. However, the shape of the slit 16 can be changed as appropriate. For example, the slit 16 may have a Y-shape in top view.

  As shown in FIGS. 4 and 5, on the top surface of the valve support portion 3b, an upper support convex portion 17 having a cylindrical shape centering on the central axis O is provided. Inner peripheral surface of the upper support convex portion 17 on the inner peripheral surface of the upper support convex portion 17, a portion radially inward of the upper support convex portion 17 on the top surface of the valve support portion 3b, and outer peripheral surface of the valve main portion 3a An upper annular recess 18 having an annular shape is formed by the portion facing the upper and lower portions. The upper support convex portion 17 is disposed in the upper support concave portion 13. An upper annular convex portion 10 is disposed in the upper annular concave portion 18. On the bottom surface of the valve support portion 3b, a lower support convex portion 19 having a cylindrical shape centering on the central axis O is provided. The inner peripheral surface of the lower support convex portion 19, the portion radially inward of the lower support convex portion 19 in the bottom surface of the valve support portion 3b, and the inner peripheral surface of the lower support convex portion 19 in the outer peripheral surface of the valve body 3a The lower annular recess 20 having an annular shape is formed by the opposing portions. The lower support projection 19 is disposed in the lower support recess 15. The lower annular convex portion 14 is disposed in the lower annular concave portion 20. The valve member 3 can be obtained, for example, by injection molding made of rubber or a thermoplastic elastomer.

  As shown in FIGS. 2 and 4, the holder 5 is suspended from an annular connecting wall 21, a male connector portion 7 consisting of a male luer depending from the inner peripheral edge of the connecting wall 21, and an outer peripheral edge of the connecting wall 21. And a lock cylinder 22 for the luer lock. On the inner peripheral surface of the lock barrel 22 is provided an internal thread 23 which enables a luer lock. On the outer peripheral edge of the top surface of the connection wall 21, a pair of standing walls 24 having an arc shape centering on the central axis O in top view is provided. The upper flange 2 c of the cap member 2 and the lower flange 4 b of the valve support member 4 are disposed radially inward of the pair of upright walls 24. A pair of projecting pieces 2 d are disposed between the pair of upright walls 24. The lower flange 4 b of the valve support member 4 and the top surface of the connection wall 21 are joined together by welding, for example. The holder 5 can be obtained, for example, by injection molding using a synthetic resin as a material.

  The medical instrument 1 has a female connector flow defined by the bottom surface of the valve body 3 a of the valve member 3, the inner peripheral surface of the inner peripheral wall 4 a of the valve support member 4, and the top surface of the connecting wall 21 of the holder 5. There is a passage 25. The female connector flow passage 25 communicates with a male connector flow passage 26 partitioned by the inner circumferential surface of the male connector portion 7. When the male luer is inserted into the connection port 8, the valve body 3 a of the valve member 3 pushed by the male luer is deformed so as to be pushed downward and the male luer fits in the connection port 8. By the deformation of the valve body 3a, the slit 16 of the valve body 3a is opened, and the flow passage inside the male luer communicates with the female connector flow passage 25. When the male luer has a lock cylinder for luer lock, the connection between the male luer and the female connector portion 6 can be reliably held by screwing the lock cylinder with the male screw 9.

  As shown in FIG. 5, the medical device 1 is integrally formed on the inner circumferential surface of the first annular portion 27 and the first annular portion 27 made of the first material, and the second material softer than the first material, And a second annular portion 28 forming the connection port 8. As used herein, "softer than the first material" means softer than the first material at normal temperature. In the present embodiment, the cap member 2 has a first annular portion 27 and a second annular portion 28. The second annular portion 28 is a part of the ceiling wall 2a. The first annular portion 27 is composed of the remaining part of the top wall 2a, the outer peripheral wall 2b, and the upper flange 2c. The second annular portion 28 is a part of the top surface of the ceiling wall 2 a (an annular portion including the inner peripheral edge of the top surface), the connection port 8, the chamfered portion 11, and the lower end surface 10 a of the upper annular convex portion 10 And a portion of the outer circumferential surface 10b of the upper annular convex portion 10 (a portion including the lower half portion of the outer circumferential surface 10b). The first annular portion 27 extends in a radial direction from the upper annular convex portion 10 at the bottom of the top wall 2 a, the remaining portion of the outer circumferential surface 10 b of the upper annular convex portion 10 and the remaining portion And an outer part. The cap member 2 can be obtained, for example, by insert molding or two-color molding.

  The first material and the second material are each a base resin, for example, a polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, etc .; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride Polystyrene, Polyamide, Polyimide, Polyamide imide, Polycarbonate, Poly- (4-methylpentene-1), Ionomer, Acrylic resin, Polymethyl methacrylate, Acrylonitrile-Butadiene-Styrene Copolymer (ABS resin) Coalesced (AS resin); butadiene-styrene copolymer; polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; Ether ketone (PEK); Polyether ether ketone (PEEK); Polyether imide; Polyacetal (POM); Polyphenylene oxide; Modified polyphenylene oxide; Polysulfone; Polyether sulfone; Polyphenylene sulfide; Polyarylate; A polytetrafluoroethylene, polyvinylidene fluoride, other fluorine-based resin, a blend or a polymer alloy containing one or more of them, and the like. Various additives may be added to the above-mentioned base resin in order to improve the material properties at the time of manufacture or the mechanical or chemical properties of the product.

  In the present embodiment, the first material comprises a fibrous filler and the second material does not comprise a fibrous filler. As a fibrous filler, glass fiber, carbon fiber etc. are mentioned, for example. By adding a fibrous filler to the base resin, rigidity can be enhanced. In the present embodiment, the first material becomes harder than the second material by using the same base resin for the first material and the second material and adding the fibrous filler to only the first material (ie, the second material) The material is adjusted to be softer than the first material). Instead of such a configuration, the first material may include the fibrous filler of the first concentration, and the second material may include the fibrous filler of the second concentration lower than the first concentration. Even with such a configuration, it is possible to adjust the second material to be softer than the first material, for example, by using the same base resin for the first material and the second material. A fibrous filler different in type from the fibrous filler contained in the first material may be included in the second material so that the second material is softer than the first material. The second material may be adjusted to be softer than the first material only by selecting the base resin and / or the additive without including the fibrous filler in any of the first material and the second material. .

  The colors of the first material and the second material may be different from each other. By doing so, the colors of the first annular portion 27 and the second annular portion 28 can be made different from each other, whereby the position of the connection port 8 can be easily recognized visually. Therefore, connectivity can be improved. The first material may be selected from materials with good durability, and the second material may be selected from materials with good chemical resistance.

  In the present embodiment, the first annular portion 27 has the anchor portion 30 which is convex over the entire circumference at the boundary surface 29 with the second annular portion 28. The anchor portion 30 has a rectangular longitudinal cross-sectional shape which is constant over the entire circumference. However, the shape of the anchor portion 30 can be changed as appropriate. The anchor portion 30 may not be provided on the boundary surface 29. The boundary surface 29 includes an annular vertical surface 29a having an anchor portion 30 at an axially intermediate portion and having a fixed inner diameter in the axial direction, and an inclined surface 29b whose diameter increases downward from the lower end of the vertical surface 29a. And an annular horizontal surface 29c extending radially outward from the lower end of the inclined surface 29b. However, the shape of the boundary surface 29 can be changed as appropriate.

  The medical device 1 according to the present embodiment is integrally formed on the inner circumferential surface of the first annular portion 27 and the first annular portion 27 made of the first material, and the second material which is softer than the first material. Since it has the 2nd annular part 28 which forms the connection port 8 which can be fitted with a thing, formation of the hard 1st annular part 27 is ensured, securing the good connectivity by formation of the soft connection port 8 Good durability can be obtained. Therefore, according to the medical instrument 1 which concerns on this embodiment, durability can be improved. In particular, in the present embodiment, since a relatively high rigidity can be given to the luer lock male screw 9 provided in the first annular portion 27, breakage or the like of the male screw 9 can be suppressed. In the medical instrument 1 according to the present embodiment, since the first annular portion 27 has the anchor portion 30, the bonding strength between the first annular portion 27 and the second annular portion 28 is enhanced to enhance the durability. Can.

  As described above, in the present embodiment, the medical instrument 1 is configured as an I-type connector. However, the medical instrument 1 may be configured as a medical connector of a different type such as, for example, a three-way stopcock as shown in FIG. 6A or a T-type connector as shown in FIG. Good. The three-way stopcock shown in FIG. 6A has a closed female connector portion 6 constituted by the cap member 2, the valve member 3 and the valve support member 4. Further, the three-way stopcock includes a housing 34 having an open female connector portion 31, an open male connector portion 32, and a flow path selecting lever member 33 instead of the holder 5. The T-shaped connector shown in FIG. 6 (b) has a closed female connector portion 6 constituted by the cap member 2, the valve member 3 and the valve support member 4. Further, the T-shaped connector includes a housing 37 having an open female connector portion 35 and an open male connector portion 36 in place of the holder 5. The male connector portion 36 is provided with a lock cylinder 38 for luer lock.

  The shapes of the cap member 2, the valve member 3 and the valve support member 4 can be changed as appropriate. The valve support member 4 may be integrally molded with the holder 5 by injection molding or the like.

  As described above, in the present embodiment, the medical instrument 1 is configured as a medical connector. However, the medical instrument 1 may be, for example, a syringe having a piston member, a syringe member, and a needle member. The syringe member may have a connection port that can be fitted with a needle member as a connection object. In this case, the syringe member is formed integrally with the first annular portion made of the first material and the second material which is softer than the first material and is formed on the inner peripheral surface of the first annular portion and can be connected with the needle member And a second annular portion that forms a mouth.

  Next, with reference to FIGS. 4 to 6 and 9, an intermediate formed body of the connection port member constituting the medical device according to the embodiment of the present invention will be exemplified and described in detail. The intermediate molded body according to the present embodiment is a secondary intermediate molded body 40 (see FIG. 9) which can be obtained by the method of manufacturing a medical device according to an embodiment of the present invention described later. However, the intermediate molded body according to the present embodiment may be obtained by another manufacturing method. The intermediate molded body according to the present embodiment corresponds to a portion of the cap member (connection port member) 2 described above excluding the second annular portion 28. That is, the intermediate molded body according to the present embodiment is an intermediate molded body of the cap member 2 (see FIGS. 4 to 5) constituting the medical device 1, and is convexly formed over the entire circumference of the inner peripheral surface 41. The anchor portion 30 is provided. According to such an intermediate molded body, a second annular portion made of a second material softer than the first material constituting the intermediate molded body, for example, by two-color molding or insert molding on the inner peripheral surface 41 of the intermediate molded body By molding 28 integrally, the cap member 2 which can improve the durability of the medical instrument 1 can be obtained. Also, according to such an intermediate molded body, strong bonding between the intermediate molded body and the second annular portion 28 can be realized by interposing the anchor portion 30. The intermediate molded body according to the present embodiment is configured with a medical device different from the medical device 1 shown in FIGS. 4 to 5 (for example, a medical connector or a syringe shown in FIGS. 6A and 6B). It may be an intermediate formed body of the connection port member. In the present specification, the connection port member means a member that forms a connection port that can be mated with the connection object.

  Next, a method of manufacturing a medical device according to an embodiment of the present invention will be illustrated and described in detail with reference to FIGS. 1 to 9. The method of manufacturing the medical device according to the present embodiment is a method of manufacturing the medical device 1 shown in FIGS. However, in the method of manufacturing the medical device according to the present embodiment, a medical device different from the medical device 1 shown in FIGS. 1 to 5 (for example, the medical connector shown in FIGS. 6 (a) and 6 (b) or It can also be used in the manufacture of syringes and the like. The medical device 1 according to the embodiment described above is not limited to the one obtained by the method of manufacturing a medical device according to the present embodiment.

  As shown in FIG. 7, in the method of manufacturing a medical device according to the present embodiment, a forming step S1 of forming a cap member 2 as a connection port member, and an assembly step of assembling the medical device 1 using the cap member 2 And S2. The forming step S1 includes a first injection step S1a for obtaining a primary intermediate molded body 39 (see FIG. 8) of the cap member 2 and a cutting step S1b for obtaining a secondary intermediate molded body 40 (see FIG. 9) for the cap member 2. And a second injection step s1c for forming the second annular portion 28 in the secondary intermediate formed body 40.

  The first injection step S1a includes a first annular portion 27 having an inner peripheral surface 41 (corresponding to the vertical surface 29a and the inclined surface 29b shown in FIG. 5) by injection molding of the first material described above, and the inner peripheral surface 41. And a central gate portion 42 connected over the entire circumference of the primary intermediate formed body 39. By flowing the molten resin radially from the central gate corresponding to the central gate portion 42 at the time of injection molding, it is possible to suppress the formation of a weld line resulting from the merging of the molten resin in the first annular portion 27. Durability can be improved by suppressing the formation of the weld line which becomes a weak part. In particular, in the case where the first material contains a fibrous filler as in the present embodiment, for example, when the first annular portion 27 is formed by flowing the molten resin from a pin gate provided at one location in the circumferential direction, a weld line is formed. It is easy to be done. However, by causing the molten resin to flow from the central gate as described above, the formation of a weld line can be suppressed even when the first material contains a fibrous filler. In the present embodiment, the central gate portion 42 includes an elongated cylindrical portion 42 a, a disk portion 42 b connected to the upper end of the cylindrical portion 42 a, an outer peripheral surface of the disk portion 42 b, and the first annular portion 27. And a connecting portion 42c connecting the inner peripheral surface 41 of the The vertical width of the connecting portion 42 c is smaller than the vertical width of the inner circumferential surface 41. However, the shape of the central gate portion 42 can be changed as appropriate.

  The cutting step S1b is a step of cutting and removing the central gate portion 42 from the first annular portion 27 of the primary intermediate molded body 39 to obtain a secondary intermediate molded body 40. In the present embodiment, as shown in FIG. 9, in the cutting step S1b, the central gate portion 42 from the first annular portion 27 of the primary intermediate formed body 39 is cut and removed leaving a part of the central gate portion 42. . Thus, the anchor portion 30 having a convex shape is formed over the entire circumference of the inner circumferential surface 41 of the first annular portion 27. More specifically, the anchor portion 30 is formed by a part of the connecting portion 42c. As described above, by providing the anchor portion 30, the bonding strength between the first annular portion 27 and the second annular portion 28 can be enhanced. In the present embodiment, the anchor portion 30 can be efficiently formed by a part of the central gate portion 42.

  The second injection step s1c is a step of forming the second annular portion 28 (see FIG. 5) covering the cut surface 43 of the central gate portion 42 in the secondary intermediate molded body 40 by injection molding of the second material described above. . In the present embodiment, the second material is made of the same base resin as the first material, and is softer than the first material because it does not contain the fibrous filler. By covering the cut surface 43 with the second annular portion 28, both improvement in durability by weld line suppression of the first annular portion 27 and improvement in connectivity by formation of the smooth and soft connection port 8 are realized. be able to. In particular, when the first annular portion 27 has a fibrous filler as in the present embodiment, the fibrous filler is exposed from the cut surface 43 and the surface is likely to be rough, but by covering with the second annular portion 28 The connection port 8 can be smoothed. In the present embodiment, the second material is ejected from a pin gate provided at a position corresponding to the lower end surface 10 a (see FIG. 5) of the upper annular convex portion 10 in the second annular portion 28. By setting the gate for the second annular portion 28 in this manner, the connection port 8 with which the male luer contacts, the chamfered portion 11 where the male luer may come into contact, and the second annular portion 28 to be wiped Both the top surface and the like can be formed on a smooth surface without the cut surface of the gate.

  In the present embodiment, the second material may contain a fibrous filler. In the present embodiment, the second material may not be softer than the first material. In the present embodiment, the second material may be identical to the first material. Also in these cases, by covering the cut surface 43 with the second annular portion 28, good connectivity by the formation of the smooth connection port 8 is ensured, and good durability due to the weld line suppression of the first annular portion 27 is achieved. You can get sex. Therefore, according to the manufacturing method of the medical instrument which concerns on this embodiment, the medical instrument 1 which improved durability can be obtained.

  The cap member 2 punches out the central gate portion 42 by the movable portion 44 of the mold with the primary intermediate molded body 39 left inside the injection molding mold, and the obtained secondary intermediate molded body 40 is formed of gold. The second material may be injected while remaining inside the mold to form the second annular portion 28 by two-color molding. Alternatively, it may be formed by insert molding in which the second intermediate formed body 40 is taken out of the mold and then inserted into another mold to inject the second material to form the second annular portion 28. After taking out the primary intermediate formed body 39 from the mold, the central gate portion 42 may be punched out to obtain a secondary intermediate formed body 40.

  The assembling step S2 is a step of assembling the medical instrument 1 using the cap member 2 obtained by the forming step S1. In the present embodiment, first, the valve member 3 is assembled by sandwiching the valve member 3 between the cap member 2 and the valve support member 4, and in this state, the cap member 2 and the valve support member 4 are mutually attached by welding, for example. Join. The valve support 4 and the holder 5 are then joined together, for example by welding. The medical device 1 can be obtained by assembling the respective members in such a manner. However, the way of assembling the medical instrument 1 can be changed as appropriate.

  The manufacturing method of the medical instrument which concerns on this embodiment can be variously changed. For example, in the method of manufacturing a medical device according to the present embodiment, the first annular portion 27 having the inner circumferential surface 41 and the central gate portion 42 connected to the inner circumferential surface 41 along the entire circumference 1 Although the process of obtaining the next intermediate molded body 39 is performed, the present invention is not limited to this, and an intermediate molded body not having the central gate portion 42 connected over the entire circumference to the inner circumferential surface 41 may be obtained. In this case, the cutting step S1b for obtaining the secondary intermediate molded body 40 by cutting and removing the central gate portion 42 from the first annular portion 27 of the primary intermediate molded body 39 is unnecessary.

  It goes without saying that the present embodiment described above is merely an example of the embodiment of the present invention, and various changes can be made without departing from the scope of the invention.

1 Medical device 2 Cap member (connection port member)
2a top wall 2b outer peripheral wall 2c upper flange 2d protrusion 3 valve member 3a valve body 3b valve support 4 valve support 4a inner peripheral wall 4b lower flange 5 holder 6 female connector 7 male connector 8 connection port 9 male screw 10 Annular convex portion 10a lower end surface 10b outer peripheral surface 11,12 chamfered portion 13 upper support concave portion 14 lower annular convex portion 14a upper end surface 14b outer peripheral surface 15 lower support concave portion 16 slit 17 upper support convex portion 18 upper annular concave portion 19 lower support convex portion 20 Lower annular recess 21 Connection wall 22 Lock cylinder 23 Female screw 24 Vertical wall 25 Female connector flow path 26 Male connector flow path 27 1st annular portion 28 2nd annular portion 29 Boundary surface 29a Vertical surface 29b Slope surface 29c Horizontal surface 30 Anchor portion 31 Female connector Part 32 Male connector part 33 Lever member 34 Housing 35 Female connector part 36 male connector portion 37 housing 38 lock cylinder 39 primary intermediate formed body 40 secondary intermediate formed body 41 inner circumferential surface 42 central gate portion 42 a disc-like portion 42 b disc-like portion 42 c connecting portion 43 cut surface 44 movable portion O center Axis

Claims (9)

A first annular portion made of a first material;
A second annular portion made of a second material that is softer than the first material and integrally formed on the inner circumferential surface of the first annular portion to form a connection port that can be fitted with a connection object;
Have a medical instrument. The first material comprises a fibrous filler,
The medical device according to claim 1, wherein the second material does not contain a fibrous filler. The first material comprises a first concentration of fibrous filler,
The medical device according to claim 1, wherein the second material comprises a second concentration of the fibrous filler lower than the first concentration.   The medical instrument according to any one of claims 1 to 3, wherein the first annular portion has an anchor portion which is convex over the entire circumference at the interface with the second annular portion. The medical device is
A cap member having the first annular portion and the second annular portion;
A valve member disposed at the connection port of the second annular portion;
The medical instrument according to any one of claims 1 to 4, which is a medical connector having: An intermediate formed body of a connection port member that constitutes a medical device and forms a connection port that can be mated with a connection object,
An intermediate formed body having an anchor portion which has a convex shape all around the inner peripheral surface. A forming step of forming a connection port member that forms a connection port that can be mated with a connection object;
An assembly step of assembling a medical instrument using the connection port member;
Have
The forming step is
An intermediate formed body forming step of forming an intermediate formed body having a first annular portion having an inner circumferential surface;
An injection step of forming a second annular portion on the inner peripheral surface of the intermediate molded body by injection molding;
Method of manufacturing medical instruments. The forming step is
First injection molding to obtain a primary intermediate molded body having the first annular portion having the inner circumferential surface and the central gate portion connected to the inner circumferential surface over the entire circumference by injection molding of the first material Process,
Cutting the central gate portion from the first annular portion of the primary intermediate molded body to obtain a secondary intermediate molded body;
A second injection step of forming the second annular portion covering the cut surface of the central gate portion of the secondary intermediate formed body by injection molding of the first material or a second material different from the first material; Have
The manufacturing method of the medical instrument of Claim 7.   In the cutting step, the central gate portion is cut and removed from the first annular portion of the primary molded body leaving a part of the central gate portion, whereby the inner circumferential surface of the first annular portion is formed. The manufacturing method of the medical instrument of Claim 8 which forms an anchor part which makes convex shape over the perimeter.

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