Medical device and method of manufacturing the same
Patent Information
- Application Number
- CN201811456298.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2017-12-28
- Filing Date
- 2018-11-30
- Publication Date
- 2026-10-23
- Estimated Expiration
- 2038-11-30
AI Technical Summary
[0044]根据本发明,可提供能够通过拓宽材料的选择自由度来提高性能的医疗用器具及其制造方法。
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Figure CN109966637B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to medical devices and methods for manufacturing the same. Background Technology
[0002] As medical devices, those with internally formed flow paths are known, for example, for purposes such as intravenous infusion or blood collection. For instance, the medical device described in Patent Document 1 includes a flow path component integrally formed facing the flow path, a non-flow path component integrally formed not facing the flow path, and a valve core held by the clamping of the flow path component and the non-flow path component. Furthermore, the non-flow path component and the flow path component are fused together.
[0003] Existing technical documents
[0004] Patent documents
[0005] Patent Document 1: Japanese Patent Application Publication No. 2015-221108 Summary of the Invention
[0006] The problem that the invention aims to solve
[0007] In existing medical connectors as described in Patent Document 1, from the viewpoint of ensuring the bonding strength between the non-flow path component and the flow path component, the non-flow path component is usually made of the same resin material as the flow path component. However, the flow path component must be made of a resin material suitable for the fluid flowing in the flow path. Therefore, the freedom of choice of material for the non-flow path component is limited. For example, when the flow path component is made of polypropylene (PP), which has excellent chemical resistance, the non-flow path component will also be made of PP. However, when the non-flow path component is made of PP, it is difficult to ensure properties such as rigidity of the non-flow path component.
[0008] In view of the above, the object of the present invention is to provide a medical device and a method thereof that can improve performance by broadening the freedom of material selection.
[0009] Methods for solving problems
[0010] The medical device, as a first aspect of the present invention, comprises:
[0011] The first component has a main body and an anchoring part, the anchoring part being made of a resin material different from that of the main body and integrally formed with the main body in a manner that connects to the main body in shape; and
[0012] The second component has a joint made of the same resin material as the anchoring part and is engaged with the anchoring part.
[0013] As one embodiment of the present invention
[0014] A flow path is formed inside the medical device.
[0015] One of the first component and the second component is a flow path component facing the flow path.
[0016] The other of the first component and the second component is a non-flow path component that does not face the flow path.
[0017] As one embodiment of the present invention
[0018] The main body and the anchoring part cooperate to form a ring-shaped part extending circumferentially along the central axis.
[0019] The anchoring portion is shaped to be connected to the main body portion in the annular portion in such a way that it restricts the movement of the main body portion along the central axis toward the joint portion away from the second component.
[0020] As one embodiment of the present invention
[0021] The main body and the anchoring part cooperate to form a ring-shaped part extending circumferentially along the central axis.
[0022] The anchoring portion is shaped to be connected to the main body in the annular portion in such a way that it restricts the main body from rotating circumferentially toward both sides of the central axis.
[0023] In one embodiment of the present invention, the medical device has a valve core that is held in place by clamping of the first component and the second component.
[0024] The second aspect of the medical device of the present invention is a medical device having a flow path formed internally, which has:
[0025] The first material section, facing the flow path, is composed of a continuous resin material; and
[0026] The second material section, which does not face the flow path, is composed of a continuous resin material different from that of the first material section, wherein...
[0027] One of the first material portion and the second material portion has an anchoring portion, which is integrally formed with the other of the first material portion and the second material portion, and is connected to the other in shape.
[0028] As one embodiment of the present invention
[0029] The other of the first and second material portions cooperates with the anchoring portion to form an annular portion extending circumferentially along the central axis.
[0030] The anchoring portion is shaped to be connected to the other of the first and second material portions in the annular portion in such a way that it restricts the movement of the other of the first and second material portions along the central axis in a direction away from the first and second material portions.
[0031] As one embodiment of the present invention
[0032] The other of the first and second material portions cooperates with the anchoring portion to form an annular portion extending circumferentially along the central axis.
[0033] The anchoring portion is shaped to be connected to the other of the first and second material portions in the annular portion in such a way that it restricts the other of the first and second material portions from rotating circumferentially toward the central axis.
[0034] In one embodiment of the present invention, the medical device has a valve core that is held in place by clamping of the first component and the second component.
[0035] A method for manufacturing a medical device, which is the first aspect of the present invention.
[0036] The medical device has the following features:
[0037] The first component has a main body and an anchoring part, the anchoring part being made of a resin material different from that of the main body and being shaped to be connected to the main body; and
[0038] The second component has a joint portion made of the same resin material as the anchoring portion.
[0039] The method for manufacturing the medical device includes:
[0040] In the first injection molding process, one of the anchoring part and the main body part is injection molded.
[0041] In the second injection molding process, with one of the anchoring portion and the main body portion positioned in the mold, the other of the anchoring portion and the main body portion is injection molded; and
[0042] The joining process involves joining the anchoring portion of the first component, obtained from the second injection process, with the joining portion of the second component.
[0043] Invention Effects
[0044] According to the present invention, a medical device and a method thereof are provided that can improve performance by expanding the freedom of material selection. Attached Figure Description
[0045] [ Figure 1 [This is a perspective view showing a medical device according to the first embodiment of the present invention.]
[0046] [ Figure 2 ]for Figure 1 An exploded perspective view of the medical device shown.
[0047] [ Figure 3 ]for Figure 1 A top view of the medical device shown.
[0048] [ Figure 4 ]for Figure 3 AA sectional view.
[0049] [ Figure 5 [Shown in the state before joining] Figure 1 A perspective view of the anchoring part of the cover component shown.
[0050] [ Figure 6 [Shown in the state before joining] Figure 1 The longitudinal sectional view of the cover component shown.
[0051] [ Figure 7 [Illustrative representation] Figure 1 A perspective view of other examples of medical devices shown.
[0052] [ Figure 8 [This is a perspective view showing a medical device according to a second embodiment of the present invention.]
[0053] [ Figure 9 ]for Figure 8 An exploded perspective view of the medical device shown.
[0054] [ Figure 10 ]for Figure 8 A top view of the medical device shown.
[0055] [ Figure 11 ]for Figure 10 AA sectional view.
[0056] [ Figure 12 [Shown in the state before joining] Figure 8 A perspective view of the anchoring part of the valve support component shown.
[0057] [ Figure 13 [Shown in the state before joining] Figure 8 The diagram shows a three-dimensional cross-sectional view of the valve support component.
[0058] [ Figure 14This is a flowchart illustrating the manufacturing process of the medical device manufacturing method according to the first and second embodiments of the present invention.
[0059] Explanation of reference numerals in the attached figures
[0060] 1A, 1B Medical devices
[0061] 2 flow path
[0062] 3 Valve support components (flow path components, second components, first material section)
[0063] 3' Valve support component (flow path component, first component)
[0064] 3a Inner peripheral wall
[0065] 3b Lower flange
[0066] 3b' Lower flange (annular portion)
[0067] 4. Cover component (non-flow path component, first component)
[0068] 4' Cover component (non-flow path component, second component, second material section)
[0069] 4a Upper flange (annular portion)
[0070] 4a' Upper flange
[0071] 4b Peripheral wall
[0072] 4c Top Wall
[0073] 4D protrusion
[0074] 5 Valve core
[0075] 5a Valve body
[0076] 5b Valve support section
[0077] 6. Retaining component (First Material Department)
[0078] 7. Female connector section
[0079] 8 Male connector section
[0080] 9. Main Body (Second Materials Department)
[0081] 10. Anchoring Section (First Material Section)
[0082] 10a Base
[0083] 10b Front end
[0084] 10c Inward flange portion
[0085] 10d inner inclined part
[0086] 10e Inner horizontal part
[0087] 10f Through-hole
[0088] 10g outwardly protruding flange
[0089] 10h Through Pass
[0090] 11 External thread
[0091] 12 connection ports
[0092] 13. Upper annular protrusion
[0093] 14 Upper support recess
[0094] 15 Lower annular protrusion
[0095] 16 Lower support recess
[0096] 17. Slit
[0097] 18 Upper support convex part
[0098] 19 upper annular recess
[0099] 20 Lower support convex part
[0100] 21 Lower annular recess
[0101] 22. Annular groove (joint)
[0102] 22' Annular groove
[0103] 23 Connecting Wall
[0104] 24 Locking cylinder
[0105] 25 internal thread
[0106] 26 standing wall
[0107] 27 Female connector flow path
[0108] 28 Male connector flow path
[0109] 29 Female connector section
[0110] 30 Male connector section
[0111] 31 Lever components
[0112] 32. Shell
[0113] 33 Female connector section
[0114] 34 Male connector section
[0115] 35 Housing
[0116] 36 Locking Cylinder
[0117] 37. Main Body (First Materials Department)
[0118] 38 Anchoring Section (Second Material Section)
[0119] 38a base
[0120] 38b external protrusion
[0121] 38c inferior protuberance
[0122] 39. Joint sleeve (joint part)
[0123] O Central axis Detailed Implementation
[0124] Hereinafter, with reference to the accompanying drawings, various embodiments of the medical device and its manufacturing method according to the present invention will be described in detail. In this specification, the term "upper and lower direction" refers to the direction along the central axis of the annular portion of the first component; "above" refers to the direction from the flow path toward the valve core; and "below" refers to the opposite direction. That is, "above" means... Figure 4 Above and below are Figure 4 Below the center. In this specification, the term "longitudinal section" refers to a section that includes the aforementioned central axis.
[0125] First, refer to Figures 1 to 7 The medical device 1A according to the first embodiment of the present invention will be described in detail by way of example. Figures 1-4As shown, the medical device 1A according to this embodiment has a cover member 4 as a first component. The cover member 4 has a main body portion 9 and an anchoring portion 10. The anchoring portion 10 is made of a resin material different from that of the main body portion 9 and is integrally formed with the main body portion 9 in a manner that is shaped to connect with the main body portion 9. Additionally, the medical device 1A3 has a valve support member 3 as a second component. The valve support member 3 has an annular groove 22 as a joint portion that engages with the anchoring portion 10. The annular groove 22 is made of the same resin material as the anchoring portion 10. Furthermore, the medical device 1A has a valve core 5 and a retainer 6. The valve core 5 is held by the clamping of the valve support member 3 and the cover member 4. In this embodiment, the cover member 4 as the first component is configured as a non-flow path component that does not face the flow path 2 formed inside the medical device 1A. Furthermore, in this embodiment, the valve support member 3 as the second component is configured as a flow path component that faces the flow path 2. The medical device 1A has a closed female connector portion 7 consisting of a valve support member 3, a cover member 4, and a valve core 5. Additionally, the medical device 1A has an open male connector portion 8 consisting of a retainer member 6. In this embodiment, the medical device 1A is configured as an I-type connector with only two connector portions arranged concentrically.
[0126] In this embodiment, the cover component 4 has a main body 9 and an anchoring portion 10. The main body 9 is made of a different resin material than the valve support component 3, while the anchoring portion 10 is made of the same resin material as the valve support component 3 and is shaped to be connected to the main body 9. The cover component 4 and the valve support component 3 are joined together via the anchoring portion 10 by welding (e.g., ultrasonic welding). However, the cover component 4 and the valve support component 3 may also be configured to be joined together via the anchoring portion 10 by means other than welding (e.g., adhesive).
[0127] The valve support component 3 faces the flow path 2 and is therefore made of a first resin material with chemical resistance. In this embodiment, the first resin material is polypropylene (PP), which has excellent chemical resistance. The first resin material is not limited to PP, but may also be, for example, polyethylene, polytetrafluoroethylene (PTFE), vinyl chloride, nylon, or ABS resin. The valve support component 3 may contain fibrous fillers such as glass fibers or carbon fibers to improve rigidity. The valve support component 3 may contain various additives to improve material properties during manufacturing, or the mechanical or chemical properties of the product. The valve support component 3 can be obtained by injection molding, for example, the first resin material.
[0128] To ensure high bonding strength with the valve support component 3, the anchoring portion 10 of the cover component 4 is made of the same first resin material as the valve support component 3. The anchoring portion 10 may contain fibrous fillers such as glass fiber or carbon fiber to improve rigidity. The anchoring portion 10 may contain various additives to improve material properties during manufacturing, or the mechanical or chemical properties of the product.
[0129] The main body 9 of the cover component 4 is made of a second resin material having a rigidity higher than that of the first resin material. In this embodiment, the second resin material is polycarbonate (PC), which has excellent rigidity. The second resin material is not limited to PC, and may also be, for example, cyclic polyolefins or acrylic resins. The main body 9 may contain fibrous fillers such as glass fibers or carbon fibers to improve rigidity. The main body 9 may contain various additives to improve material properties during manufacturing, or the mechanical or chemical properties of the product.
[0130] The cover component 4 can be obtained by injection molding in two stages, for example: while the anchoring part 10, which is injection molded from the first resin material, is placed in the mold, a second resin material is injected, thereby molding the main body 9 and the anchoring part 10 into one piece. The cover component 4 can also be obtained by insert molding the anchoring part 10, which is injection molded from the first resin material, into the mold and then injecting the second resin material. The cover component 4 can also be obtained by two-color molding by injecting the second resin material while the anchoring part 10, which is injection molded from the first resin material, remains in the mold.
[0131] like Figure 2 and Figure 6 As shown, the main body 9 of the cover component 4 cooperates with the anchoring part 10 to form an upper flange 4a, which is an annular portion extending circumferentially along the central axis O. The upper flange 4a is in the shape of an annular flange. However, the shape of the upper flange 4a can be appropriately modified. The anchoring part 10 is shaped to be connected to the main body 9 in the upper flange 4a in such a way that it restricts the movement of the main body 9 toward both axial sides (i.e., above and below) and both circumferential sides (i.e., clockwise and counterclockwise) along the central axis O. However, the anchoring part 10 may also be configured to be shaped to be connected to the main body 9 in the upper flange 4a in such a way that it only restricts the movement of the main body 9 toward either either axial sides or circumferential sides along the central axis O. Alternatively, the anchoring part 10 may be configured to be shaped to be connected to the main body part 9 in the upper flange 4a in such a way that it only restricts the main body part 9 from moving axially upward along the central axis O (i.e., in the direction away from the annular groove 22 of the valve support member 3 along the central axis O).
[0132] In this specification, the phrase "connected in shape to the main body 9 in a manner that restricts the movement of the main body 9 toward both sides along the central axis O" indicates that the anchoring part 10 has a portion that is clamped by the main body 9 from both sides along the axial direction, and / or a portion that clamps the main body 9 from both sides along the axial direction. For example... Figures 5-6 As shown, in this embodiment, a through-hole 10h is formed on the anchoring portion 10, which is inclined relative to the central axis O. The anchoring portion 10 is connected to the main body portion 9 through this through-hole 10h. The through-hole 10h may also be oriented in a direction perpendicular to the central axis O. In this way, by configuring the anchoring portion 10 and the main body portion 9 to be connected through a through-hole oriented in a direction inclined relative to the central axis O or in a direction perpendicular to the central axis O, it is possible to effectively suppress the anchoring portion 10 from peeling off from the main body portion 9 towards both sides along the axial direction of the central axis O.
[0133] In this specification, the phrase "connected in shape to the main body 9 in a manner that restricts the movement of the main body 9 toward both sides of the circumference along the central axis O" indicates that the anchoring part 10 has a portion that is clamped by the main body 9 from both sides of the circumference, and / or a portion that clamps the main body 9 from both sides of the circumference. Figures 5-6 As shown, in this embodiment, the anchoring portion 10 has through-holes 10f and 10h that are perpendicular to the circumferential direction of the central axis O. The anchoring portion 10 is connected to the main body portion 9 through these through-holes 10f and 10h. The through-holes 10f and 10h may also be oriented in a direction inclined relative to the circumferential direction of the central axis O. In this way, by configuring the anchoring portion 10 and the main body portion 9 to be connected through through-holes that are perpendicular to the circumferential direction of the central axis O or inclined relative to the circumferential direction of the central axis O, it is possible to effectively suppress the anchoring portion 10 from peeling off from both sides of the main body portion 9 in the circumferential direction of the central axis O.
[0134] like Figure 5 and Figure 6 As shown, the anchoring portion 10 has an annular shape extending circumferentially along the central axis O and a base 10a with a rectangular longitudinal section over the entire circumference. A front end portion 10b is connected to the lower end of the base 10a. The front end portion 10b is cylindrical, extending circumferentially along the central axis O, and its thickness decreases downwards. The inner circumferential surface of the front end portion 10b is enlarged by connecting to the lower edge of the inner circumferential surface of the base 10a via a stepped portion, and has a constant inner diameter in the vertical direction. The outer circumferential surface of the front end portion 10b forms a conical shape that narrows downwards from the lower end of the outer circumferential surface of the base 10a. The base 10a and the front end portion 10b are exposed from the main body portion 9.
[0135] An annular inwardly projecting flange 10c is connected to the upper end of the base 10a. The inwardly projecting flange 10c extends radially inward from the upper end of the base 10a toward the central axis O and extends circumferentially along the central axis O. The inwardly projecting flange 10c has an inwardly inclined portion 10d and an inwardly horizontal portion 10e. The inwardly inclined portion 10d slopes upward radially inward from the upper end of the base 10a toward the central axis O, and the inwardly horizontal portion 10e extends horizontally radially inward from the inner periphery of the inwardly inclined portion 10d. A plurality of (more specifically, 10) through-holes 10f are formed on the inwardly projecting flange 10c. These through-holes 10f are equally spaced circumferentially along the central axis O at the connection between the inwardly inclined portion 10d and the inwardly horizontal portion 10e. The inwardly projecting flange 10c is held by the main body 9 from both sides in the vertical direction. The inner sides of the multiple through-holes 10f are filled by a portion of the main body 9. The entire inward flange portion 10c is embedded in the main body 9.
[0136] An annular outward flange 10g is connected to the outer periphery of the inward flange 10c. The outward flange 10g extends radially outward from the outer periphery of the inward flange 10c toward the central axis O and extends circumferentially toward the central axis O. The outward flange 10g slopes upward radially outward from the outer periphery of the inward flange 10c toward the central axis O. A plurality of (more specifically, 10) through-holes 10h are formed on the outward flange 10g, and the plurality of through-holes 10h are arranged at equal intervals circumferentially along the central axis O. The plurality of through-holes 10h formed on the outward flange 10g are arranged to be radially aligned with the plurality of through-holes 10f formed on the inward flange 10c. The inner sides of the plurality of through-holes 10h are filled by a portion of the main body 9. A portion of the upper end face and outer peripheral face of the outwardly projecting flange 10g protrude from the main body 9, while the remaining portion is embedded in the main body 9 (see [reference]). Figure 2 and Figure 5 ).
[0137] The shape of the anchoring portion 10 can be appropriately modified. For example, the base 10a can also be an annular shape other than a circular ring. The longitudinal cross-sectional shape of the base 10a is not limited to a rectangle. The shape of the front end portion 10b can be appropriately modified. The inward flange portion 10c can also be an annular shape other than a circular ring. The inward flange portion 10c can extend horizontally as a whole, or it can be inclined relative to the horizontal as a whole. The number of through openings 10f formed in the inward flange portion 10c can be increased or decreased. Multiple through openings 10f can also be arranged at equal intervals in the circumferential direction. It is also possible to have no through openings 10f formed on the inward flange portion 10c. The outward flange portion 10g can also be an annular shape other than a circular ring. The outward flange portion 10g can also extend horizontally. The number of through openings 10h formed in the outward flange portion 10g can be increased or decreased. Multiple through openings 10h can also be arranged at equal intervals in the circumferential direction. Alternatively, the configuration may not have a through-hole 10h formed on the outward flange portion 10g. It may also have a configuration with only either the inward flange portion 10c or the outward flange portion 10g. Alternatively, a configuration may be provided instead of the inward flange portion 10c and the outward flange portion 10g, for example, with an annular vertical wall portion extending upward parallel to the central axis O from the upper end of the base portion 10a, and extending circumferentially along the central axis O, and shapedly connected to the main body portion 9. In this case, a plurality of through-holes may be formed on this vertical wall portion, and the plurality of through-holes may be arranged at intervals circumferentially along the central axis O.
[0138] like Figure 2 and Figure 4 As shown, the main body 9 of the cover component 4 has a cylindrical outer peripheral wall 4b and an annular top wall 4c. The outer peripheral wall 4b extends upward from the inner peripheral edge of the upper flange 4a and extends circumferentially along the central axis O. The top wall 4c extends radially inward from the upper edge of the outer peripheral wall 4b and extends circumferentially along the central axis O. Additionally, the main body 9 of the cover component 4 has a pair of tabs 4d, which extend radially outward from two opposite positions on the outer peripheral edge of the upper flange 4a, separated by the central axis O. The number of tabs 4d can be varied appropriately. Alternatively, the tabs 4d can be omitted. An external thread 11 capable of Luer locking is provided on the outer peripheral surface of the outer peripheral wall 4b. In this embodiment, the external thread 11 is formed by two threads. However, the shape of the external thread 11 can be varied appropriately. A shape-locking portion other than the thread, capable of shape-locking for maintaining the male Luer connector, can also be provided instead of the external thread 11. It can also be configured without any shape-locking parts.
[0139] The main body 9 of the cover component 4 has a connection port 12 that can be fitted with a Luer connector. The connection port 12 is formed by the inner peripheral surface of the annular top wall 4c. In this embodiment, the connection port 12 has a constant inner diameter (e.g., 4.15 mm) in the vertical direction. However, the shape of the connection port 12 can be appropriately modified. For example, the connection port 12 can also be formed into a tapered shape that narrows downwards. An upper annular protrusion 13 in the shape of a cylinder with the central axis O as the center is provided on the bottom surface of the top wall 4c. An upper support recess in the shape of an annular is formed by the outer peripheral surface of the upper annular protrusion 13, the portion of the bottom surface of the top wall 4c that is radially outward from the upper annular protrusion 13, and the portion of the inner peripheral surface of the outer peripheral wall 4b that faces the outer peripheral surface of the upper annular protrusion 13.
[0140] like Figure 2 and Figure 4 As shown, the valve support member 3 has: an inner peripheral wall 3a that coincides with the inner peripheral surface of the outer peripheral wall 4b of the cover member 4; and a lower flange 3b in the shape of an annular ring that extends radially outward from the lower end of the inner peripheral wall 3a and contacts the bottom surface of the upper flange 4a of the cover member 4. A lower annular protrusion 15, cylindrical in shape and centered on the central axis O, is provided on the top surface of the inner peripheral wall 3a. A lower support recess in the shape of an annular ring is formed by the outer peripheral surface of the lower annular protrusion 15, the portion of the top surface of the inner peripheral wall 3a that is radially outward from the lower annular protrusion 15, and the portion of the inner peripheral surface of the outer peripheral wall 4b of the cover member 4 that faces the outer peripheral surface of the lower annular protrusion 15.
[0141] like Figure 2 and Figure 4 As shown, the valve core 5 is disposed at the connection port 12. The valve core 5 has a cylindrical valve body portion 5a capable of closing the connection port 12, and an annular valve support portion 5b extending radially outward from the outer periphery of the valve body portion 5a. The valve body portion 5a has a slit 17, which can be pushed open by a male Luer connector inserted into the connection port 12. In this embodiment, the slit 17 is straight (in a line) in plan view. However, the shape of the slit 17 can be appropriately modified. For example, the slit 17 can also be Y-shaped in plan view.
[0142] An upper support protrusion 18, cylindrical in shape and centered on the central axis O, is provided on the top surface of the valve support portion 5b. An upper annular recess 19, circular in shape, is formed by the inner circumferential surface of the upper support protrusion 18, the portion of the top surface of the valve support portion 5b that is radially inward beyond the upper support protrusion 18, and the portion of the outer circumferential surface of the valve body portion 5a that faces the inner circumferential surface of the upper support protrusion 18. The upper support protrusion 18 is disposed in the upper support recess 14. An upper annular protrusion 13 is disposed on the upper annular recess 19. A lower support protrusion 20, cylindrical in shape and centered on the central axis O, is provided on the bottom surface of the valve support portion 5b. A lower annular recess 21, circular in shape, is formed by the inner circumferential surface of the lower support protrusion 20, the portion of the bottom surface of the valve support portion 5b that is radially inward beyond the lower support protrusion 20, and the portion of the outer circumferential surface of the valve body portion 5a that faces the inner circumferential surface of the lower support protrusion 20. A lower support protrusion 20 is disposed on a lower support recess 16. A lower annular protrusion 15 is disposed on a lower annular recess 21. The valve core 5 can be obtained by injection molding, for example, using rubber or thermoplastic elastomer as the material.
[0143] like Figure 2 and Figure 4 As shown, an annular groove 22 is formed on the top surface of the lower flange 3b of the valve support member 3. The annular groove 22 is circular in shape, extending circumferentially along the central axis O, and its longitudinal section is rectangular over the entire circumference. The base 10a and the front end 10b of the anchoring portion 10 are disposed on the annular groove 22 (see [reference]). Figure 6 The front end portion 10b of the anchoring portion 10 is melted by, for example, applying ultrasonic waves, and then cooled and solidified after being deformed to fill the inner side of the annular groove 22. In this way, the valve support member 3 and the cover member 4 can be joined together via the anchoring portion 10 in a clamping state for the valve core 5. When the front end portion 10b of the anchoring portion 10 melts and deforms to fill the inner side of the annular groove 22, the distance between the upper annular protrusion 13 and the lower annular protrusion 15 is shortened, thereby compressing the portion of the valve core 5 disposed between the upper annular recess 19 and the lower annular recess 21. Thus, the valve core 5 is firmly fixed by the valve support member 3 and the cover member 4. However, it is also possible to configure the portion of the valve core 5 disposed between the upper annular recess 19 and the lower annular recess 21 without compressing it. It is also possible to join the anchoring portion 10 and the valve support member 3 together by means other than welding (e.g., adhesive).
[0144] like Figure 2 and Figure 4As shown, the retainer 6 is configured as an integrally molded component facing the flow path 2. To ensure high bonding strength with the valve support component 3, the retainer 6 is made of the same first resin material as the valve support component 3. The retainer 6 may contain fibrous fillers such as glass fiber or carbon fiber to improve rigidity. The retainer 6 may contain various additives to improve material properties during manufacturing, or the mechanical or chemical properties of the product. The retainer 6 can be obtained by injection molding, for example, the first resin material.
[0145] The retainer 6 has an annular connecting wall 23, a male connector portion 8 formed by a male Luer connector hanging from the inner periphery of the connecting wall 23, and a locking cylinder 24 for Luer locking hanging from the outer periphery of the connecting wall 23. An internal thread 25 for Luer locking is provided on the inner periphery of the locking cylinder 24. A pair of upright walls 26, which are arc-shaped about the central axis O when viewed from above, are provided on the outer periphery of the top surface of the connecting wall 23. An upper flange 4a of the cover member 4 and a lower flange 3b of the valve support member 3 are arranged radially inside the pair of upright walls 26. A pair of tabs 4d are arranged between the pair of upright walls 26. The bottom surface of the lower flange 3b of the valve support member 3 and the top surface of the connecting wall 23 are joined together by welding. Furthermore, the outer periphery of the lower flange 3b of the valve support member 3 and the inner periphery of the pair of upright walls 26 are joined together by welding. It can also be configured such that the lower flange 3b of the valve support member 3 and the retainer 6 are joined together by means other than welding (e.g., adhesive).
[0146] The medical device 1A has a female connector flow path 27 defined by the bottom surface of the valve body 5a of the valve core 5, the inner peripheral surface of the inner peripheral wall 3a of the valve support member 3, and the top surface of the connecting wall 23 of the retainer 6. The female connector flow path 27 communicates with a male connector flow path 28 defined by the inner peripheral surface of the male connector 8. The internal flow path 2 of the medical device 1A is formed by the female connector flow path 27 and the male connector flow path 28. When the male Luer connector is inserted into the connection port 12, the valve body 5a of the valve core 5, which is pushed by the male Luer connector, deforms in a way that it is pressed downward and extends, and the male Luer connector fits into the connection port 12. Through this deformation of the valve body 5a, the slit 17 of the valve body 5a is opened, and the flow path inside the male Luer connector communicates with the female connector flow path 27. When the male Luer connector has a locking sleeve for Luer locking, the connection between the male Luer connector and the female connector portion 7 can be maintained more reliably by screwing the locking sleeve into the external thread 11. In particular, in this embodiment, since the main body portion 9 of the cover member 4 is made of a second resin material with high rigidity, the external thread 11 for Luer locking can be given high rigidity, and damage to the external thread 11 can be suppressed. The medical device 1A can be configured such that the male Luer connector does not engage with the connection port 12, but is maintained in a connected state with the connection port 12 only by, for example, the engagement of the locking sleeve and the external thread 11.
[0147] like Figure 4 As shown, the medical device 1A has a first material section facing the flow path 2, which is made of a continuous first resin material. In this embodiment, the first material section is formed by an anchoring part 10, a valve support member 3, and a retaining member 6. Additionally, the medical device 1A has a second material section not facing the flow path 2, which is made of a continuous second resin material different from the first material section. In this embodiment, the second material section is formed by the main body 9 of the cover member 4. In this embodiment, the first material section has an anchoring part 10, which is integrally formed with the second material section and is shaped to be connected to the second material section. The second material section and the anchoring part 10 cooperate to form an upper flange 4a as an annular portion extending circumferentially along the central axis O. The anchoring part 10 is shaped to be connected to the second material section in the upper flange 4a in a manner that restricts the movement of the second material section toward both axial sides and circumferential sides along the central axis O. However, the anchoring part 10 may also be configured to be shaped to be connected to the second material part in the upper flange 4a in such a way that it restricts the movement of the second material part only toward either the axial sides or the circumferential sides of the central axis O. Alternatively, the anchoring part 10 may also be configured to be shaped to be connected to the second material part in the upper flange 4a in such a way that it restricts the movement of the second material part only toward the axial upward direction along the central axis O (i.e., in the direction away from the first material part along the central axis O). The valve core 5 is held by the clamping of the first material part and the second material part.
[0148] In the medical device 1A according to this embodiment, the cover member 4, as a non-flow path component, has an anchoring portion 10 made of a resin material different from that of the main body 9 and integrally formed with the main body 9 in a shape-connected manner. The valve support member 3, as a flow path component, has a joining portion (annular groove 22) made of the same resin material as the anchoring portion 10 and engaged with the anchoring portion 10. Therefore, the rigidity of the cover member 4 can be improved while ensuring high bonding strength between the cover member 4 and the valve support member 3. In other words, the first material part of the medical device 1A according to this embodiment has an anchoring portion 10 integrally formed with and shaped to the second material part. Therefore, the rigidity of the second material part can be improved while preventing the second material part from peeling off from the first material part. Therefore, by using the medical device 1A according to this embodiment, performance can be improved by increasing the degree of freedom in material selection.
[0149] As described above, in this embodiment, the medical device 1A is configured as a type I connector. However, the medical device 1A may also be configured as, for example, as shown below. Figure 7 (a) The three-way stopcock shown in the image or as shown in the image Figure 7 (b) shows different types of medical connectors such as the T-type connector. Figure 7 The three-way stopcock shown in (a) has a closed female connector portion 7 consisting of a cover member 4, a valve core 5, and a valve support member 3. In addition, the three-way stopcock has a housing 32 (which has an open female connector portion 29, an open male connector portion 30, and a lever member 31 for selecting the flow path) instead of the retainer 6. Figure 7 The T-type connector shown in (b) has a closed female connector portion 7 consisting of a cover member 4, a valve core 5, and a valve support member 3. Additionally, the T-type connector includes a housing 35 (which has an open female connector portion 33 and an open male connector portion 34) instead of a retainer 6. A locking cylinder 36 for Luer locking is provided on the male connector portion 34.
[0150] The shapes of the cover component 4, valve core 5, and valve support component 3 can be modified appropriately. The valve support component 3 is configured to be integrally formed with the retainer 6 by injection molding or other methods.
[0151] Next, use Figures 8-13 The medical device 1B according to the second embodiment of the present invention will be described in detail by way of example. Figures 8-11 As shown, in the medical device 1B according to this embodiment, the valve support member 3', which is a flow path component, is configured as a first component. The valve support member 3' has a main body portion 37 and an anchoring portion 38. The anchoring portion 38 is made of a resin material different from that of the main body portion 37 and is integrally formed with the main body portion 37 in a manner that is shaped to connect with the main body portion 37. In addition, in the medical device 1B according to this embodiment, the cover member 4', which is a non-flow path component, is configured as a second component. The cover member 4' has a connecting cylinder 39 made of the same resin material as the anchoring portion 38 and serves as a connecting portion that engages with the anchoring portion 38. In other aspects, the medical device 1B according to this embodiment has the same configuration as the medical device 1A according to the first embodiment.
[0152] like Figure 9 and Figure 13As shown, in this embodiment, the main body 37 of the valve support member 3' cooperates with the anchoring part 38 to form a lower flange 3b' as an annular portion extending circumferentially along the central axis O. The anchoring part 38 is shaped to be connected to the main body 37 in the lower flange 3b' in such a way that it restricts the movement of the main body 37 toward both axial sides and circumferential sides along the central axis O. However, the anchoring part 38 may also be configured to be shaped to be connected to the main body 37 in the lower flange 3b' in such a way that it restricts the movement of the main body 37 toward either axial sides or circumferential sides along the central axis O. Alternatively, the anchoring part 38 may be configured to be shaped to be connected to the main body 37 in the lower flange 3b' in such a way that it restricts the movement of the main body 37 toward only the axial downward direction along the central axis O (i.e., in the direction away from the connecting cylinder 39 of the cover member 4' along the central axis O).
[0153] like Figures 12-13 As shown, the anchoring portion 38 has an annular base 38a extending circumferentially along the central axis O and having a rectangular longitudinal section over the entire circumference. The upper surface of the base 38a protrudes from the lower flange 3b'. An annular groove 22' is formed in the lower flange 3b', with the upper surface of the base 38a as its bottom. The remaining portion of the base 38a is embedded in the main body portion 37.
[0154] A plurality of plate-shaped (more specifically, nine) external protrusions 38b are connected to the outer peripheral surface of the base 38a. These protrusions 38b are equally spaced circumferentially along the central axis O and protrude radially outward from the central axis O. Each external protrusion 38b has the same thickness as the base 38a. Each external protrusion 38b is held by the main body 37 from both sides in the vertical direction. The outer peripheral surfaces of each external protrusion 38b are exposed from the main body 37 before the cover member 4' and the valve support member 3' are welded together. The remaining portions of each external protrusion 38b are embedded in the main body 37.
[0155] A plurality of plate-shaped (more specifically, nine) lower protrusions 38c are connected to the bottom surface of the base 38a. These lower protrusions 38c are equally spaced circumferentially along the central axis O and protrude radially inward from the inner circumferential surface of the base 38a. The bottom surface of each lower protrusion 38c protrudes from the main body 37. The remaining portions of each lower protrusion 38c are embedded in the main body 37. The lower protrusions 38c are arranged radially aligned with a plurality of outer protrusions 38b. The lower protrusions 38c have the same circumferential width as the outer protrusions 38b. Each lower protrusion 38c has the same thickness as the base 38a.
[0156] The anchoring part 38 is made of the same second resin material (PC in this embodiment) as the cover part 4'. The main body part 37 is made of the first resin material (PP in this embodiment).
[0157] The valve support component 3' can be obtained by injection molding in two stages, for example: with the anchoring part 38, which is injection molded from the second resin material, placed in the mold, the first resin material is injected, thereby molding the main body 37 and the anchoring part 38 into one piece. The valve support component 3' can also be obtained by insert molding, where the anchoring part 38, which is injection molded from the second resin material, is inserted into the mold, and the first resin material is injected. Alternatively, the valve support component 3' can be obtained by two-color molding, where the anchoring part 38, which is injection molded from the second resin material, remains in the mold, and the first resin material is injected.
[0158] The shape of the anchoring portion 38 can be appropriately modified. For example, the base 38a can also be annular in shape other than circular. The longitudinal cross-sectional shape of the base 38a is not limited to rectangle. The shape of the outer protrusion 38b can be appropriately modified. The number of outer protrusions 38b can be increased or decreased. Multiple outer protrusions 38b can also be arranged at equal intervals in the circumferential direction. The shape of the lower protrusion 38c can be appropriately modified. The number of lower protrusions 38c can be increased or decreased. Multiple lower protrusions 38c can also be arranged at equal intervals in the circumferential direction.
[0159] like Figure 11 As shown, the cover component 4' has a cylindrical connecting tube 39 that protrudes downward from the bottom surface of the upper flange 4a' and extends circumferentially along the central axis O. Figure 11 In this process, the connecting cylinder 39 is melted by, for example, applying ultrasonic waves, and then cooled and solidified after being deformed to fill the inner side of the annular groove 22' of the valve support member 3'. This allows the valve support member 3' and the cover member 4' to be joined together via the anchoring portion 38 while the valve core 5 is clamped. When the connecting cylinder 39 melts and deforms to fill the inner side of the annular groove 22', the distance between the upper annular protrusion 13 and the lower annular protrusion 15 is shortened, thereby compressing the portion of the valve core 5 positioned between the upper annular recess 19 and the lower annular recess 21. Thus, the valve core 5 is firmly fixed by the valve support member 3' and the cover member 4'. However, it is also possible to configure the portion of the valve core 5 positioned between the upper annular recess 19 and the lower annular recess 21 without compressing it. Alternatively, the cover member 4' and the anchoring portion 38 can be joined together by means other than welding (e.g., adhesive).
[0160] like Figure 11As shown, the medical device 1B has a first material section facing the flow path 2, which is made of a continuous first resin material. In this embodiment, the first material section is formed by the main body 37 of the valve support member 3' and the retainer 6. Additionally, the medical device 1B has a second material section not facing the flow path 2, which is made of a continuous second resin material different from the first material section. In this embodiment, the second material section is formed by the cover member 4' and the anchoring portion 38 of the valve support member 3'. In this embodiment, the second material section has the anchoring portion 38, which is integrally formed with the first material section and is shaped to be connected to the first material section. The first material section and the anchoring portion 38 cooperate to form a lower flange 3b' as an annular portion extending circumferentially along the central axis O. The anchoring portion 38 is shaped to be connected to the first material section in the lower flange 3b' in a manner that restricts the movement of the first material section toward both the axial sides along the central axis O and the circumferential sides along the central axis O. However, the anchoring part 38 can also be configured to be shaped to be connected to the first material part in the lower flange 3b' in such a way that it restricts the movement of the first material part only towards either the axial sides or the circumferential sides of the central axis O. Alternatively, the anchoring part 38 can also be configured to be shaped to be connected to the first material part in the lower flange 3b' in such a way that it restricts the movement of the first material part only towards the axial downward direction along the central axis O (i.e., in the direction away from the second material part along the central axis O). The valve core 5 is held by the clamping of the first material part and the second material part.
[0161] In the medical device 1B according to this embodiment, the valve support member 3', which is a flow path component, has an anchoring portion 38 made of a resin material different from that of the main body 37 and integrally formed with the main body 37 in a shape-connected manner. The cover member 4', which is a non-flow path component, has a joining portion (joining cylinder 39) made of the same resin material as the anchoring portion 38 and joined with the anchoring portion 38. Therefore, the rigidity of the cover member 4' can be improved while ensuring high bonding strength between the cover member 4' and the valve support member 3'. In other words, the second material part of the medical device 1B according to this embodiment has an anchoring portion 38 integrally formed with the first material part and integrally formed with it in shape. Therefore, the rigidity of the second material part can be improved while preventing the second material part from peeling off from the first material part. Therefore, by using the medical device 1B according to this embodiment, performance can be improved by increasing the degree of freedom in material selection.
[0162] In this embodiment, the medical device 1B is configured as a Type I connector. However, similar to the first embodiment, the medical device 1B may be configured as, for example, as shown in the example... Figure 7 (a) The three-way stopcock shown in the image or as shown in the image Figure 7 (b) shows different types of medical connectors such as the T-type connector.
[0163] The shapes of the cover component 4', valve core 5, and valve support component 3' can be modified appropriately. The valve support component 3' can be configured to be integrally formed with the retainer 6 by injection molding or other methods.
[0164] Next, use Figure 14 The manufacturing method of the medical device according to the first embodiment of the present invention will be described in detail with examples. The manufacturing method of the medical device according to this embodiment involves manufacturing... Figures 1-6 The method for manufacturing the medical device 1A shown is described. However, the medical device 1A according to the first embodiment described above is not limited to the medical device obtained by the manufacturing method of the medical device according to this embodiment.
[0165] like Figure 14 As shown, the manufacturing method of the medical device according to this embodiment includes: a first injection step S1, in which the anchoring part 10 (see...) is injected into the device. Figure 5 Injection molding; second injection step S2, in which the main body 9 is injection molded with the anchoring part 10 placed in the mold; and joining step S3, in which the anchoring part 10 of the cover part 4 (first part) obtained by the second injection step S2 is joined with the annular groove 22 (joining part) of the valve support part 3 (second part).
[0166] First, in the first injection molding process S1, the anchoring portion 10 is injection molded using the aforementioned first resin material. The aforementioned fibrous filler and / or additives may be added to the first resin material.
[0167] Next, in the second injection process S2, the main body 9 and the anchoring part 10 are molded together by insert molding (inserting the anchoring part 10 obtained in the first injection process S1 into the mold and injecting the aforementioned second resin material), thus obtaining the cover part 4 (see...). Figure 6 The aforementioned fibrous filler and / or additives can be added to the second resin material. In the second injection step S2, the main body 9 and the anchoring part 10 can also be molded into one piece by two-color molding (injecting the second resin material while the anchoring part 10 obtained in the first injection step S1 remains in the mold) to obtain the cover part 4.
[0168] Next, in the joining process S3, the cap component 4, valve support component 3, and valve core 5 obtained from the second injection process S2 are first assembled by clamping the valve core 5 with the cap component 4 and valve support component 3. Then, by applying ultrasonic waves, for example, the anchoring portion 10 of the cap component 4 is fused with the annular groove 22 of the valve support component 3, thereby obtaining an assembly of the cap component 4, valve support component 3, and valve core 5. At this time, the anchoring portion 10 and the annular groove 22 of the valve support component 3 are made of the same first resin material, thus ensuring high bonding strength. In the joining process S3, the front end portion 10b of the anchoring portion 10 can also be melted by applying ultrasonic waves, for example, to deform it so as to fill the inner side of the annular groove 22, thereby shortening the distance between the upper annular protrusion 13 and the lower annular protrusion 15, compressing the portion of the valve core 5 positioned between the upper annular recess 19 and the lower annular recess 21. This allows the valve core 5 to be securely fixed to the valve support component 3 and the cap component 4. In the joining process S3, the anchoring part 10 and the valve support part 3 can also be joined together by means other than welding (e.g., adhesive).
[0169] Next, the assembly of the cover member 4, valve support member 3, and valve core 5 obtained from the joining process S3 is assembled onto the retainer 6. Furthermore, by applying ultrasound, for example, the valve support member 3 and the retainer 6 are fused together to obtain the medical device 1A. At this time, the valve support member 3 and the retainer 6 are made of the same first resin material, thus ensuring high bonding strength. The valve support member 3 and the retainer 6 can also be joined together by means other than fusion (e.g., adhesives).
[0170] Alternatively, the valve support member 3 and the retainer 6 can be joined before the joining process S3. In the joining process S3, the cover member 4 and the valve core 5 are assembled onto the valve support member 3, and the cover member 4 and the valve support member 3 are joined together via the anchoring part 10.
[0171] Using the manufacturing method of the medical device according to this embodiment, a medical device 1A with improved performance can be obtained by expanding the freedom of material selection. The manufacturing method of the medical device according to this embodiment can also be used to manufacture medical devices different from medical device 1A (e.g., three-way valves or T-connectors).
[0172] Next, use Figure 14 The manufacturing method of the medical device according to the second embodiment of the present invention will be described in detail with examples. The manufacturing method of the medical device according to this embodiment involves manufacturing... Figures 8-13 The method for manufacturing the medical device 1B shown is described. However, the medical device 1B according to the aforementioned second embodiment is not limited to the medical device obtained by the manufacturing method of the medical device according to this embodiment.
[0173] like Figure 14 As shown, the manufacturing method of the medical device according to this embodiment includes: a first injection step S1, in which the anchoring part 38 (see...) is injected into the device. Figure 12 Injection molding; second injection step S2, in which the main body 37 is injection molded with the anchoring part 38 placed in the mold; and joining step S3, in which the valve support member 3' (first part) obtained by the second injection step S2 is joined with the joining cylinder 39 (joining part) of the cover member 4' (second part).
[0174] First, in the first injection molding process S1, the anchoring portion 38 is injection molded using the aforementioned second resin material. The aforementioned fibrous filler and / or additives may be added to the second resin material.
[0175] Next, in the second injection process S2, the main body 37 and the anchoring part 38 are molded together by insert molding (inserting the anchoring part 38 obtained in the first injection process S1 into the mold and injecting the aforementioned first resin material), thus obtaining the valve support component 3' (see...). Figure 13 The aforementioned fibrous filler and / or additives can be added to the first resin material. In the second injection step S2, the main body 37 and the anchoring part 38 can also be molded into one piece by two-color molding (injecting the first resin material while the anchoring part 38 obtained in the first injection step S1 remains in the mold) to obtain the valve support component 3'.
[0176] Next, in the joining process S3, the cover component 4', the valve support component 3' obtained from the second injection process S2, and the valve core 5 are first assembled by clamping the valve core 5 with the cover component 4' and the valve support component 3'. Then, by applying ultrasonic waves, for example, the joining cylinder 39 of the cover component 4' is fused with the anchoring portion 38 of the valve support component 3', thereby obtaining an assembly of the cover component 4', the valve support component 3', and the valve core 5. At this time, the joining cylinder 39 and the anchoring portion 38 of the cover component 4' are made of the same second resin material, thus ensuring high bonding strength. In the joining process S3, the joining cylinder 39 of the cover component 4' can also be melted by applying ultrasonic waves, for example, to deform it in a way that fills the inner side of the annular groove 22', thereby shortening the distance between the upper annular protrusion 13 and the lower annular protrusion 15, and compressing the portion of the valve core 5 positioned between the upper annular recess 19 and the lower annular recess 21. Thus, the valve core 5 can be securely fixed to the valve support member 3' and the cover member 4'. In the joining process S3, the cover member 4' and the anchoring part 38 can also be joined to each other by means other than welding (e.g., adhesive).
[0177] Next, the assembly of the cover member 4', valve support member 3', and valve core 5 obtained from the joining process S3 is assembled onto the retainer 6. Then, by applying ultrasonic waves, for example, the main body 37 of the valve support member 3' is fused to the retainer 6, thereby obtaining the medical device 1B. At this time, the main body 37 of the valve support member 3' and the retainer 6 are made of the same first resin material, thus ensuring high bonding strength. Alternatively, the main body 37 of the valve support member 3' and the retainer 6 can be joined together by means other than fusion (e.g., adhesives).
[0178] Alternatively, the main body 37 of the valve support member 3' can be joined to the retainer 6 before the joining process S3. In the joining process S3, the cover member 4' and the valve core 5 are assembled to the valve support member 3', and the cover member 4' and the valve support member 3' are joined to each other via the anchoring part 10.
[0179] Using the manufacturing method of the medical device according to this embodiment, a medical device 1B with improved performance can be obtained by expanding the degree of freedom in material selection. The manufacturing method of the medical device according to this embodiment can also be used to manufacture medical devices different from medical device 1B (e.g., three-way valves or T-connectors).
[0180] The aforementioned implementation method is merely one example of the implementation method of the present invention, and various modifications can be made without departing from the spirit of the invention.
Claims
1. Medical devices, which have the following characteristics: A first component has a main body and an anchoring portion. The main body has a cylindrical outer peripheral wall. The anchoring portion is made of a resin material different from that of the main body and is integrally formed with the main body by injection molding in a shape-connected manner to restrict movement of the main body toward both axial and circumferential sides along the central axis of the cylindrical outer peripheral wall. The main body and the anchoring portion form an upper flange extending radially outward from the lower end of the outer peripheral wall. The second component has a joining portion made of the same resin material as the anchoring portion and is joined to the anchoring portion. The second component has: an inner peripheral wall that coincides with the inner peripheral surface of the outer peripheral wall; and a lower flange that extends radially outward from the lower end of the inner peripheral wall and contacts the bottom surface of the upper flange. The joint is formed on the lower flange. A flow path is formed inside the medical device. One of the first component and the second component is a flow path component facing the flow path. The other of the first component and the second component is a non-flow path component that does not face the flow path.
2. The medical device as described in claim 1, wherein, The main body and the anchoring part cooperate to form a ring-shaped part extending circumferentially along the central axis. The anchoring portion is shaped to be connected to the main body portion in the annular portion in such a way that it restricts the movement of the main body portion along the central axis toward the joint portion away from the second component.
3. The medical device as described in claim 1 or 2, wherein, The main body and the anchoring part cooperate to form a ring-shaped part extending circumferentially along the central axis. The anchoring portion is shaped to be connected to the main body in the annular portion in such a way that it restricts the main body from rotating circumferentially toward both sides of the central axis.
4. The medical device as claimed in claim 1 or 2, having a valve core that is held by clamping of the first component and the second component.
5. Medical devices, which are medical devices with internal flow paths, and which have the following characteristics: The first material section, facing the flow path, is composed of a continuous resin material; and The second material section, which does not face the flow path, is composed of a continuous resin material different from that of the first material section, wherein... One of the first material portion and the second material portion has an anchoring portion, which is integrally formed with the other of the first material portion and the second material portion by injection molding and is connected to the other in shape. The other of the first and second material portions cooperates with the anchoring portion to form an annular portion extending circumferentially along the central axis. The anchoring portion is shaped to be connected to the other of the first and second material portions in the annular portion in such a way that it restricts the other of the first and second material portions from moving away from the first and second material portions along the central axis and restricts the other of the first material portion from rotating circumferentially toward both sides of the central axis.
6. The medical device of claim 5, wherein the valve core is held by clamping of the first material portion and the second material portion.
7. A method for manufacturing a medical device, wherein the medical device comprises: A first component has a main body and an anchoring portion. The main body has a cylindrical outer peripheral wall. The anchoring portion is made of a resin material different from that of the main body and is shaped to connect with the main body to restrict movement of the main body toward both axial and circumferential sides along the central axis of the cylindrical outer peripheral wall. The main body and the anchoring portion form an upper flange extending radially outward from the lower end of the outer peripheral wall. The second component has a joint made of the same resin material as the anchoring portion. The second component has: an inner peripheral wall that coincides with the inner peripheral surface of the outer peripheral wall; and a lower flange extending radially outward from the lower end of the inner peripheral wall and contacting the bottom surface of the upper flange. The joint is formed on the lower flange. A flow path is formed inside the medical device. One of the first component and the second component is a flow path component facing the flow path. The other of the first and second components is a non-flow path component that does not face the flow path. The method for manufacturing the medical device includes: In the first injection molding process, one of the anchoring part and the main body part is injection molded. In the second injection process, with one of the anchoring part and the main body part positioned in the mold, the other of the anchoring part and the main body part is injection molded. and The joining process involves joining the anchoring portion of the first component obtained from the second injection process with the joining portion of the second component.
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