Medical Connectors

Abstract

To achieve a medical connector which is excellent in safety and the like.SOLUTION: A medical connector includes a body part 101 having an insertion port and an elastic valve body 102 for closing the insertion port. The body part 101 includes: a cap 120 having a cylindrical part 121 that constitutes the insertion port and has a screw part on a side surface and a cap side flange 122 provided on a base end of the cylindrical part 121; and a base 110 connected to the cap side flange. The cap side flange 122 covers an upper end of the base 110 and has a positioning part for positioning a circumferential position relative to the base 110 on a surface on a side of the base 110.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to medical connectors, and more particularly to needleless medical connectors. [Background technology]

[0002] The infusion route is provided with a port for injecting medicinal fluids or collecting samples, and the port generally uses a male connector or a needleless connector that can be directly connected to a syringe.

[0003] The needleless connector has two tube ports connected to an infusion route, a liquid flow path connecting the tube ports, and an insertion port that protrudes in a direction intersecting the liquid flow path and into which a male connector or the like is inserted. An elastic valve that can be opened by inserting the male connector is fixed to the insertion port.

[0004] To facilitate the manufacture of needleless connectors, a method is being considered in which the connector housing is molded into two parts: a connector base with a liquid flow path and a cap with an insertion port, and the cap incorporating an elastic valve body is then combined with the connector base (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2016-147077 Summary of the Invention [Problem to be solved by the invention]

[0006] However, dividing the housing into a connector base and a cap poses various problems in terms of safety and reliability. One problem is the formation of grooves or steps at the boundary between the connector base and the cap, which makes wiping difficult and reduces safety and reliability. Patent Document 1 discloses a pair of locking claws protruding radially outward from the periphery of the flange, a pair of grooves and hooking walls that receive the locking claws at the upper end of the peripheral wall of the connector base, and the locking claws are fitted into the grooves and hooked onto the hooking walls to position the cap and connector base in the correct positions, improving manufacturing efficiency. However, in this case, the locking claws create grooves and steps on the upper surface of the flange. The flange at the base end of the insertion port is touched by the fingers of the operator and patient during placement, and is also abutted by the coupler of the male connector. Therefore, it is necessary to keep it clean to prevent the growth of bacteria, etc. However, grooves and steps in the flange make wiping difficult and reduce safety and reliability.

[0007] Another problem is that the contact area of ​​the bottom of the connector base with the skin is small, which can injure the skin and reduce safety and reliability. In Patent Document 1, in order to improve the molding accuracy of the flow path, etc., a cavity that opens to the bottom of the connector base is provided to prevent sink marks during molding, but since the area of ​​the part that contacts the skin is small, pressure on the skin increases. Needleless connectors are sometimes attached to the patient's skin to prevent movement, and the bottom of the connector base may cause pain to the patient or injure the skin during long-term placement, reducing safety and reliability.

[0008] Furthermore, one issue is that improving the reliability of the connection mechanism between the connector base and the cap results in an increase in size, which makes it more likely to come into contact with other components during placement, resulting in a decrease in safety. The connector base and the cap must be firmly fixed to prevent separation. Patent Document 1 proposes connecting the connector base and the cap by providing a recess on the top of the connector base, fitting the cap into the recess, and welding or gluing them together. However, because the welded or glued portion is minute, manufacturing precision is required, and defects in this process can cause serious problems such as overflow of adhesive. For this reason, mechanical connection by engagement between an engaging claw and an engaging hole is preferred. However, with mechanical connection methods, force is concentrated at the engaging portion, making the engaging portion susceptible to damage. Enlarging the engaging portion to increase its strength results in an increase in size. However, increasing the size of the connecting portion makes it more likely to come into contact with other components during placement, resulting in a decrease in safety.

[0009] Another issue is that needleless connectors with an internal valve body must accommodate the valve while also achieving an inner diameter that allows the insertion of a standardized male connector and an outer shape that allows the coupler to fit, resulting in a thin cap. With the recent increase in thick-walled syringes, such as pre-filled syringes, the torque required to fit the syringe coupler tends to increase, making the cap more susceptible to deformation.

[0010] The medical connector of the present disclosure aims to solve at least one of these problems that arise in medical connectors. [Means for solving the problem]

[0011] A first aspect of the medical connector of the present disclosure comprises a main body having an insertion port into which a male connector is inserted, and an elastic valve body that closes the insertion port, wherein the main body comprises a cylindrical portion that forms the insertion port and has a threaded portion on its side, a cap having a cap side flange provided at the base end of the cylindrical portion, and a base that connects to the cap side flange, and the cap side flange covers the upper end of the base and has a positioning portion on its base side surface that positions the cap circumferentially relative to the base.

[0012] According to one aspect of the medical connector of the present disclosure, a positioning portion for circumferentially positioning the cap and base is formed on the base-side surface of the cap flange. That is, the positioning portion is not on the upper surface of the cap flange, and no grooves or steps are formed around the positioning portion on the upper surface. This makes it easy to wipe clean and effectively prevents the growth of bacteria, etc., thereby significantly improving safety and reliability.

[0013] A second aspect of the medical connector of the present disclosure comprises a main body having an insertion port into which a male connector is inserted, and an elastic valve body that closes the insertion port, the main body having a base and a cap attached to the base, the cap forming the insertion port into which the male connector is inserted and having a tubular portion with a threaded portion on the side, and the base having a bottom plate formed with a contact surface that contacts the skin in a planar manner, and a cavity that opens to the side.

[0014] According to a second aspect of the medical connector of the present disclosure, the medical connector has a cavity that opens to a side, which prevents the base having a bottom plate from becoming excessively thick when it is molded, thereby preventing sink marks during molding, and also dispersing the force applied to the patient's skin by having the bottom plate come into planar contact with the patient's skin, preventing injury to the patient and improving safety and reliability.

[0015] In each aspect of the medical connector of the present disclosure, the base may have a fluid flow path extending in a direction intersecting the insertion port, and the cavity may extend parallel to the fluid flow path. This configuration improves moldability of the fluid flow path.

[0016] A third aspect of the medical connector of the present disclosure comprises a main body having an insertion port into which a male connector is inserted, and an elastic valve body that closes the insertion port, wherein the main body has a base and a cap attached to the base, the cap forms the insertion port into which the male connector is inserted and has a tubular portion with a threaded portion on the side, the base and the cap have a connecting mechanism that connects them by fitting an engaging claw into an engaging hole that receives the engaging claw, the engaging hole being formed by a pair of side walls located on the sides of the engaging claw and a connecting wall that connects the pair of side walls, and the weld line is formed at a position different from the connecting wall.

[0017] According to a third aspect of the medical connector of the present disclosure, the weld line is located at a position different from the connection wall, which prevents a decrease in strength of the connection wall to which a load is applied from the engaging claw when a force is applied in a direction that moves the base and cap apart from each other, thereby improving safety and reliability without increasing the size of the connection wall.

[0018] In each aspect of the medical connector of the present disclosure, the engagement hole may be provided in the base, and the base may have a liquid flow path extending in a direction intersecting the insertion port and a bottom plate on which a gate mark is formed in a position that does not overlap the liquid flow path in a plan view. By using such a configuration, it is possible to easily form a weld line in a position different from the connection wall.

[0019] In each aspect of the medical connector of the present disclosure, the engaging hole may be provided in the base, and the base may have a cavity below the engaging hole, and the cavity may form a thin portion on one side of the pair of side walls below the engaging hole. In this way, a narrow portion of the resin flow path is created in the mold that molds the base, and it is possible to control the resin not to rejoin at the connecting wall position.

[0020] A fourth aspect of the medical connector of the present disclosure comprises a main body having an insertion port into which a male connector is inserted, and an elastic valve body that blocks the insertion port, the main body having a base and a cap attached to the base, the cap forming the insertion port into which the male connector is inserted and having a tubular portion with a threaded portion on the side, the base and the cap having a connecting mechanism that connects them to each other by fitting an engaging claw into an engaging hole that receives the engaging claw, and the hardness of the cap is greater than that of the base.

[0021] According to a fourth aspect of the medical connector, the base and cap are connected to each other by engaging the engaging claws with the engaging holes that receive the engaging claws. Unlike needleless connectors in which the connector base and cap are connected by welding or the like, the connector base and cap do not need to be made of materials with similar hardness. The cap can be made of a wide range of materials, and its hardness can be made higher than that of the base. This makes it less likely for the cap to deform, even when a high-hardness syringe, such as a prefilled syringe, is threaded onto the cylindrical portion, thereby improving the safety and reliability of the medical connector. Furthermore, by reducing the hardness of the base, the base can be appropriately deformed when the cap is fitted to the base, which also has the advantage of improving assembly.

[0022] In a fourth aspect of the medical connector, the elastic valve body may have a central portion and a skirt-shaped portion formed on the outer periphery of the central portion, the base may have an inner tubular portion that fits tightly against the inner surface of the skirt-shaped portion, and the cap may have a tubular portion that fits tightly against the outer surface of the skirt-shaped portion. According to this aspect, the cap does not come into contact with blood or medicine, etc., which allows for greater freedom in the selection of materials for the cap, making it easier to select a material with high hardness for the cap. [Effects of the Invention]

[0023] The medical connector of the present disclosure can solve at least one of the problems with medical connectors. [Brief explanation of the drawings]

[0024] [Figure 1] 1 is a perspective view showing a connector according to one embodiment; [Figure 2] FIG. 2 is a perspective view showing a cap portion of the connector. [Figure 3] FIG. 2 is a perspective view showing a base portion of the connector. [Figure 4] 1 is a cross-sectional view showing a connector according to an embodiment. [Figure 5] FIG. 1 is a bottom view illustrating a connector according to an embodiment. [Figure 6] FIG. 2 is a perspective view showing the flow of resin during molding. [Figure 7] FIG. 10 is a cross-sectional view showing a connector according to a modified example. DETAILED DESCRIPTION OF THE INVENTION

[0025] As shown in Figure 1, the medical needleless connector of the present disclosure has a main body 101 and an elastic valve body 102. The main body 101 has a base 110 and a cap 120. The positioning of the needleless connector of this embodiment when used is not particularly limited, but in the following description, the cap 120 side will be referred to as "upper" and the base 110 side as "lower."

[0026] As shown in FIG. 2, the cap 120 has a cylindrical portion 121 that forms an insertion port into which a male connector is inserted, and a cap-side flange 122 provided at the base end of the cylindrical portion 121. A threaded engagement portion 127 that engages with a coupler of a male connector is provided on the outer surface of the cylindrical portion 121. When a typical medical male luer is inserted, the outer diameter of the cylindrical portion 121 excluding the threaded engagement portion 127 is approximately 7 mm, and the height from the cap-side flange 122 is approximately 5 mm. A cylindrical protrusion 124 is provided to protrude from the opposite side (underside) of the cap-side flange 122 from the cylindrical portion 121. Four ribs 125 serving as positioning portions are provided at equal intervals on the bottom side of the cap-side flange 122, and engagement claws 126 that protrude radially outward are provided between the four ribs 125. The four ribs 125 extend downward from the cap-side flange 122, and more specifically, extend radially outward from the side surface of the cylindrical protrusion .

[0027] In this embodiment, the rib 125 is connected and integrated not only with the cylindrical protrusion 124 but also with the underside of the cap-side flange 122. Therefore, the rib 125 has the function of reinforcing the cap-side flange 122. However, it is sufficient that the rib 125 is connected and integrated with at least one of the underside of the cap-side flange 122 and the side surface of the cylindrical protrusion 124. Also, although an example has been shown in which the engaging claws 126 are provided on the side surface of the cylindrical protrusion 124, the engaging claws 126 are not limited to this configuration. For example, it is also possible to provide independent engaging claws 126 for each. In this case, it is also possible to configure the device without providing the cylindrical protrusion 124.

[0028] As shown in Figures 3 and 4, the base 110 has a connecting portion 111 to which the cap 120 is connected, a bottom plate 113 spaced apart from the connecting portion 111, and an intermediate portion 112 between the connecting portion 111 and the bottom plate 113.

[0029] The intermediate section 112 has a first port 141 and a second port 142 that protrude laterally. The first port 141 and the second port 142 are arranged in a straight line and are connected to each other by a liquid flow path 143 provided in the intermediate section 112.

[0030] The connecting portion 111 has an upper surface opening 151 at the center of the upper surface, which exposes the liquid flow path 143. An inner wall 152 is provided surrounding the upper surface opening 151, and an intermediate wall 153 is provided outside the inner wall 152, and a peripheral wall 154 is provided surrounding these.

[0031] In this embodiment, an inner cylindrical portion 128 is housed inside the cylindrical portion 121 of the cap 120. When the inner cylindrical portion 128 is housed inside the cylindrical portion 121 and attached to the connecting portion 111, the lower end of the inner cylindrical portion 128 is formed to fit between the inner wall 152 and the intermediate wall 153 of the connecting portion 111. The inner surface of the inner cylindrical portion 128 and the outer surface of the inner wall 152 are fitted together liquid-tightly, so that liquid in the insertion port does not leak to the outside. In addition, the upper end of the inner cylindrical portion 128 is located at a predetermined distance from the upper end of the cylindrical portion 121, and a space is provided between the outer wall surface of the inner cylindrical portion 128 and the inner wall surface of the cylindrical portion 121.

[0032] In this embodiment, the elastic valve body 102 has a slit 171a into which the male connector is inserted, and has an outer diameter approximately equal to that of the upper end opening 131 of the cylindrical portion 121. The elastic valve body 102 has a central portion 171 exposed from the upper end opening 131, an outer edge portion 172 housed inside the cylindrical portion 121, and a narrow portion 173 provided between the central portion 171 and the outer edge portion 172 and forming an upper groove and a lower groove between the central portion 171 and the outer edge portion 172. The lower end of the outer edge portion 172 extends downward beyond the lower end of the central portion 171 to form a skirt-shaped portion 174. A valve body flange portion 175 extending radially outward is provided at the lower end of the skirt-shaped portion 174.

[0033] When the elastic valve body 102, the base 110, and the cap 120 are assembled, the upper fixed claws 132 provided on the outer edge of the upper end opening 131 of the tubular portion 121 are inserted into the upper groove of the elastic valve body 102. Also, the lower fixed claws 133 provided on the upper end of the inner tubular portion 128 are inserted into the lower groove of the elastic valve body 102. The skirt-shaped portion 174 of the elastic valve body 102 is housed in the space between the tubular portion 121 and the inner tubular portion 128. The upper and lower surfaces of the valve body flange portion 175 are sandwiched and compressed between the upper end of the intermediate wall 153 of the connecting portion 111 and the convex portion provided at the lower end of the tubular portion 121, respectively.

[0034] When a male connector is inserted into elastic valve body 102, central portion 171 is pushed outward to open slit 171a, and the upper surface of central portion 171 abuts against the side surface of the male connector, and is pushed down while rotating around narrow portion 173 as a fulcrum until the surface of slit 171a faces downward. Because a large force is applied to elastic valve body 102 when inserting or removing the male connector, tubular portion 121 and inner tubular portion 128 that hold elastic valve body 102 must be firmly fixed to prevent relative movement. In this embodiment, by connecting base 110 and cap 120, tubular portion 121 and inner tubular portion 128 are each fixed to base 110, and the positions of both are thereby fixed relative to each other.

[0035] In this embodiment, the base 110 and the cap 120 are connected by fitting a cylindrical protrusion 124 provided on the underside of the cap flange 122 of the cap 120 into a peripheral wall 154 provided on the connecting portion 111, engaging the rib 125 with a groove 155 provided in the peripheral wall 154, and engaging the engagement claw 126 with an engagement hole 156 provided in the peripheral wall 154. By engaging the rib 125 with the groove 155, the cap 120 can be easily positioned correctly relative to the base 110, thereby improving manufacturing efficiency. Furthermore, since the relative rotation between the cap 120 and the base 110 is restricted, even if a rotational force is applied when inserting or removing a male connector into or from the insertion port, the base 110 and the cap 120 can be fixed so as not to rotate relative to each other. In this way, the rib 125 functions as a positioning portion that determines the circumferential position of the cap 120 relative to the base 110.

[0036] In this embodiment, the cylindrical protrusion 124, rib 125, and engagement claw 126, which are connected parts involved in connecting with the base, are provided on the underside of the cap-side flange 122. The cap-side flange 122 also covers the connecting part 111, including the upper end surface of the peripheral wall 154, so that it is not exposed, and the upper surface is flush and flat. This prevents grooves and steps from occurring at the base end of the cylindrical part 121.

[0037] In this embodiment, the relative rotation between the base 110 and the cap 120 is restricted by engaging the positioning portion, rib 125, with the groove portion 155. However, it is also possible to provide a protrusion on the connecting portion 111 side and a positioning portion that is a recess on the underside of the cap side flange 122 to receive the protrusion.

[0038] In the case of a medical connector in which the insertion port protrudes in a direction intersecting the liquid flow path, the flange surface intersecting the insertion port forms the base of the insertion port. It is preferable to enlarge the flange surface to a certain extent. Specifically, while the outer diameter of a typical medical Luer connector is approximately 7 mm, from the perspective of operability, it is preferable to make the outer diameter of the flange surface approximately 1.3 to 3 times that, approximately 9 to 20 mm. The flange surface, which is enlarged for operability, is likely to be touched by patients and operators, increasing the possibility of bacterial contamination. Furthermore, if liquid leaks when inserting or removing a male connector into or from the insertion port, the leaked liquid is likely to adhere to the flange surface extending in a direction intersecting the insertion port, further facilitating the proliferation of bacteria. In medical settings and at-home procedures, the connection operation with a male connector can be complicated, and if the male connector coupler comes into contact with a flange surface on which bacteria have proliferated, it could lead to an infection. For this reason, it is preferable that the flange surface be shaped so that it can be easily wiped. However, if a rotation limiting claw or the like that protrudes radially outward is provided as a positioning portion to improve the ease of assembly of the cap and base, a groove or step will be created around the positioning portion, making it difficult to wipe this area.

[0039] In this embodiment, the cap-side flange 122 has a larger outer diameter than the peripheral wall 154 and a flush, flat surface with no irregularities on its upper surface. All components involved in connecting the cap 120 to the base are located on the underside of the cap-side flange. This allows for a flat, easily wiped flange surface, unlike a flange with radially protruding components involved in the connection. Here, "flat" refers to a surface without steps or irregularities, and includes sloped or curved surfaces. The cap-side flange 122 covers the upper surface of the connecting portion 111, including the peripheral wall 154, so that it is not exposed. The cap-side flange 122 has a larger outer diameter than the peripheral wall 154. From the standpoints of operability and strength, it is preferable for the outer diameters of the cap-side flange 122 and the peripheral wall 154 to be equal. However, the outer diameter of the cap-side flange 122 may be smaller than the outer diameter of the peripheral wall 154 as long as the cleanliness of the flange surface can be ensured. In this embodiment, a gap exists between the lower surface of the cap side flange 122 and the upper end surface of the peripheral wall 154. This prevents the lower surface of the cap side flange 122 from coming into contact with the upper end surface of the peripheral wall 154 before the engagement claws 126 and the engagement holes 156 are fully engaged, thereby preventing a situation in which poor engagement occurs between the engagement claws 126 and the engagement holes 156. However, a configuration in which the lower surface of the cap side flange 122 comes into contact with the upper end surface of the peripheral wall 154 may also be used.

[0040] In this embodiment, four grooves 155 are provided, and peripheral wall 154 is divided into four regions. In this embodiment, two of grooves 155 are provided in the direction in which liquid flow path 143 extends, and the remaining two are provided in a direction perpendicular to liquid flow path 143. The four regions of peripheral wall 154 are arranged symmetrically, two by two, with liquid flow path 143 between them.

[0041] Furthermore, in this embodiment, the base 110 and the cap 120 are connected by fitting the engaging claws 126 into the engaging holes 156. Therefore, the base 110 and the cap 120 can be firmly connected without welding or adhering the cylindrical protrusion 124 and the peripheral wall 154. However, the cylindrical protrusion 124 and the peripheral wall 154 may be welded or adhered. In this case, the engaging claws 126 and the engaging holes 156 may not be provided. Also, the rib 125 may be configured to be welded or adhered to the peripheral wall 154 at the groove 155. In this case, the cylindrical protrusion 124 may not be provided.

[0042] The engagement claws 126 are provided between the four ribs 125, respectively, and the engagement holes 156 are provided in the four regions of the peripheral wall 154. Therefore, by aligning the ribs 125 of the cap 120 with the grooves 155 and pushing the cap 120 in, the engagement claws 126 and the engagement holes 156 are also aligned.

[0043] Needleless connectors, which insert a male connector into an insertion port, are required to be compact, yet must be designed to withstand complex operations in medical settings, ensuring sufficient strength to prevent breakage of each component. However, it is difficult to engage the engagement claws with a thick, non-deformable tubular portion. For this reason, in this embodiment, four grooves 155 are provided in the peripheral wall 154, dividing it into four regions. This facilitates outward deformation of the peripheral wall 154, facilitating the connection of the engagement claws 126. Furthermore, the grooves 155 accommodate the ribs 125 on the cap 120, preventing the cap 120 connected to the connecting portion 111 from rotating relative to the base 110 during assembly, improving manufacturing efficiency.

[0044] In this embodiment, the circumferential width of the rib 125 is matched to the circumferential width of the groove 155, and after the rib 125 is received in the groove 155, deformation of the peripheral wall 154 is unlikely to occur, ensuring sufficient strength. In this embodiment, the lower end of the rib 125 is tapered, making it easy to insert the rib 125 into the groove 155. Note that the peripheral wall 154 is not limited to being divided into four parts, and may be divided into, for example, two or six parts, or may not be divided at all. Furthermore, the number of ribs 125 may be matched to the number of grooves 155, but the number of ribs 125 may be less than the number of grooves 155, and there may be grooves 155 into which no rib 125 is inserted.

[0045] In this embodiment, the grooves 155 are wider in the direction in which the liquid flow paths 143 extend, and narrower in the direction perpendicular to the liquid flow paths 143. To match the grooves 155, the ribs 125 are alternately wide and narrow. The cap 120 is positioned relative to the base 110 every 180° to match the wide grooves 155 with the wide ribs 125 and the narrow grooves 155 with the narrow ribs 125. In this embodiment, a double-thread thread is provided on the outer surface of the cylindrical portion 121, and the cap 120 has two-fold rotational symmetry. Therefore, positioning every 180° allows the start position of the thread to be constant. The grooves 155 and ribs 125 can also be made three or four different widths so that they can always be attached in a constant direction.

[0046] In this embodiment, the upper end surface of the engagement claw 126 protrudes horizontally from the cylindrical protrusion 124 and has a generally triangular cross section that gradually narrows downward. The engagement hole 156 is formed by a pair of side walls 161 extending upward and a connecting wall 162 connecting the ends of the side walls 161. Therefore, when the engagement claw 126 is engaged with the engagement hole 156, the side walls 161 are located on both sides of the engagement claw 126. The connecting wall 162 has a guide portion 163 that is notched obliquely on the upper inner periphery. Therefore, by pushing the cap 120, the engagement claw 126 can easily ride over the connecting wall 162 along the guide portion 163, allowing the engagement claw 126 to easily engage with the engagement hole 156. On the other hand, the portion of the connecting wall 162 that forms the upper end surface of the engagement hole 156 is a horizontal surface, and even if an attempt is made to pull the cap 120 upward, the upper end surface of the engagement claw 126 and the upper end surface of the engagement hole 156 abut against each other, and a force is applied to each other in the vertical direction, so that the engagement claw 126 cannot be easily separated from the engagement hole 156.

[0047] In this embodiment, the engagement holes 156 are formed in a generally fan-like shape that gradually widens from the radially inner side toward the radially outer side when viewed from above. This prevents large variations in the thickness of the peripheral wall 154, making it less likely that distortion will occur in the peripheral wall 154. However, the engagement holes 156 are not limited to this shape as long as they can engage with the engagement claws 126. Furthermore, the engagement portions that engage with the engagement claws 126 are not limited to through-holes that penetrate the peripheral wall 154 like the engagement holes 156, but may also be recesses that do not penetrate the peripheral wall 154.

[0048] To ensure the strength of the entire connector, it is important to ensure not only the strength of the connection between the base 110 and the cap 120, but also the strength of the base 110 itself. One way to ensure the strength of the base is to make the area around the liquid flow path solid. However, simply making the entire base solid can result in an excessively thick wall, which can lead to sink marks. If sink marks occur, they can cause distortion in the liquid flow path, impairing the flow of liquid and causing stagnation.

[0049] On the other hand, if the bottom end of the base is curved significantly to create a cavity that opens to the bottom surface in order to prevent sink marks when molding the base, only the bottom end surface of the side wall of the base will come into contact with the patient's skin, which will concentrate force on a specific part of the patient's skin, causing pressure pain or injury to the skin.

[0050] In this embodiment, a bottom plate 113 is formed below the intermediate portion 112, and cavities 145 are formed on both sides of the liquid flow path 143, extending parallel to the liquid flow path 143 and opening to the side of the intermediate portion 112. The cavities 145 function as recesses during molding, preventing the base 110 from becoming too thick and suppressing the occurrence of sink marks. In addition, the lower surface of the bottom plate 113 forms a contact surface that comes into planar contact with the patient's skin, and because the contact surface is wide and comes into planar contact with the patient's skin, it is possible to avoid pressure concentration.

[0051] Specifically, a liquid flow path outer wall 187 surrounding the liquid flow path 143 stands up in the center of the bottom plate 113, reaching the lower surface of the connecting portion 111. An intermediate side wall 185, which is approximately parallel to the liquid flow path 143, stands up on the outer edge of the bottom plate 113 and reaches the lower surface of the connecting portion 111. The intermediate side wall 185 and the liquid flow path outer wall 187 are connected by a partition wall 186 provided in the center. Therefore, the cavity 145 is surrounded by the upper surface of the bottom plate 113, the lower surface of the connecting portion 111, the liquid flow path outer wall 187, the intermediate side wall 185, and the partition wall 186.

[0052] The lower surface of bottom plate 113 is preferably as flat as possible to distribute the pressure applied to the patient's skin. However, slight depressions such as gate marks from molding may be present on the lower surface of bottom plate 113. Furthermore, since the surface of the patient's skin is curved, taking this into consideration, the bottom plate may not be completely flat, but may be curved with a slight depression in the center.

[0053] In this embodiment, the bottom plate 113 has two gate marks 181 equidistant from the center of the bottom surface in a direction perpendicular to the liquid flow path 143. When the base 110 and the cap 120 are connected by the engagement of the engagement claws 126 and the engagement holes 156, as in this embodiment, maintaining the strength of the peripheral wall 154 in which the engagement holes 156 are formed is extremely important. If the base 110 is molded using a mold in which the gate is located at the center of the bottom plate 113, weld lines will occur in the connecting wall 162 in each of the four divided regions of the peripheral wall 154, as indicated by lines B in FIG. 6 . This will reduce the strength of the portion of the peripheral wall 154 in which the engagement holes 156 are formed. By providing gates at two locations offset from the center of the bottom plate 113, the weld lines can be shifted to four locations (positions A in FIG. 6 ) near the bases of each port in the intermediate section 112. This makes it easier to ensure the strength of the portion in which the engagement holes 156 are formed. However, the molding method for the base in this embodiment is not limited to this method, and any method can be used as long as it does not create a weld line in the connecting wall 162 of the peripheral wall 154. Specifically, as shown in FIG. 5, the gate position of the mold is adjusted so that the gate mark 181 is formed at a position offset so as not to overlap the liquid flow path 143 in a plan view. It is also preferable that the gate position does not overlap the connecting wall 162 in a plan view. By using such a mold, it is possible to prevent the resin from rejoining at the position of the connecting wall 162 above the engagement hole 156. Furthermore, in this embodiment, the thicknesses of the partition walls 186 provided on the upper and lower surfaces of the cavity 145 indicated by C1 and C2 in FIG. 3 and at the back of the cavity 145 indicated by C3 in FIG. 5 are reduced to provide narrow portions in the resin flow paths of the mold, thereby controlling the position where the resin rejoins. In this way, by forming a resin flow path connected to one of the pair of side walls 161 that is narrower than the resin flow path connected to the other side wall, it is possible to slow down the molding speed of the one side wall and prevent weld lines from being formed in the connecting wall 162. Furthermore, by providing the gate trace in a position close to the other side wall, it is possible to speed up the molding speed of the other side wall and prevent weld lines from being formed in the connecting wall 162. Note that although having multiple gates makes it easier to design the mold, it is also possible to use only one gate.

[0054] In this embodiment, the engaging claws, which are the connecting mechanism for connecting the base and the cap, are formed on the cap side, and the engaging holes are formed on the base side. However, it is also possible to form the engaging claws on the base side and the engaging holes on the cap side. In this case, it is sufficient to control the flow of resin on the cap side to prevent welds from occurring in the connecting wall portion.

[0055] In this embodiment, the first port 141 and the second port 142 are cylindrical so that the infusion line tubes fit over them, but they may have any shape as long as they can be connected to the infusion line tubes. Also, they may be connected to the infusion line tubes via a connector.

[0056] In this embodiment, four outer surface ribs 183 extending in the vertical direction are provided on the outer surface of the base 110. Providing the outer surface ribs 183 makes it easier to grip the connector and improves operability. Furthermore, the outer shape of the base 110 may be an oval or polygonal shape with parallel sides instead of a flat circular shape.

[0057] In this embodiment, a partition wall 144 is provided in the center of the liquid flow path 143. Due to the partition wall 144, the liquid flowing between the first port 141 and the second port 142 flows temporarily into the insertion port side. This prevents the liquid injected from the insertion port from stagnating in the insertion port. However, the partition wall 144 may be provided as needed, and does not necessarily have to be provided. Furthermore, although the present embodiment has been illustrated as a connector in which the insertion port extends in a direction perpendicular to the liquid flow path, the present invention is not limited to this. For example, the present invention can also be applied to a Y-shaped connector or a connector having a stopcock that changes the liquid flow path.

[0058] In this embodiment, an example has been shown in which the skirt-shaped portion 174 is provided below the outer edge portion 172 of the elastic valve body 102, but it is not necessary to provide the skirt-shaped portion 174 so that it reaches the base 110. For example, from the standpoint of making it less likely to fall off, it is preferable that the lower end of the outer edge portion 172 is lower than the lower end of the central portion 171, but it can also be at the same position as the lower end of the central portion 171. Note that in connectors with a threaded portion into which a male connector is inserted, cracks and contamination of the upper surface of the cap-side flange portion due to complicated operations are likely to occur, so a connector into which a male connector is inserted is preferable.

[0059] The base 110 and the cap 120 are not particularly limited and can be formed from various resin materials. In this embodiment, the base 110 and the cap 120 do not need to be welded or bonded, so the base 110 and the cap 120 can easily be formed from different materials. For example, the base 110 can be formed from acrylic-butadiene-styrene (ABS), polycarbonate, acrylic, hard vinyl chloride, etc. Hard vinyl chloride is particularly preferred because it is easy to connect to a tube. The cap 120 is preferably formed from polyethylene, polypropylene, polyoxymethylene, or the like, which are easy to mold and not easily broken.

[0060] By making the hardness of the cap 120 higher than that of the base 110, it is possible to make the cylindrical portion 121 less likely to deform or break when the male connector is inserted into the insertion port. When inserting or withdrawing the male connector into the insertion port, a large force is applied to the insertion port. In particular, pre-filled syringes, which are filled with a medicinal solution, are often formed with a thick wall from the viewpoint of barrier properties, etc., and the torque applied to the cylindrical portion 121, which is the insertion port, when the coupler is screwed tends to be large. For this reason, the cap 120 is required to have a strength that can withstand pre-filled syringes, etc.

[0061] However, the outer diameter of the luer portion of the male connector and the inner diameter of the coupler are both regulated by standards, limiting the design flexibility of female connectors. Furthermore, if a valve body can be positioned between the inner surface of the female connector and the luer portion of the male connector, the maximum design thickness of the female connector, i.e., the tubular portion 121, that meets the standards is approximately 1.27 mm. Therefore, it is virtually impossible to ensure strength by increasing the wall thickness of the tubular portion 121. Furthermore, in the case of a needleless connector in which the cap and base are welded together, the melting points of the cap and base must be approximately the same, making it virtually impossible to use materials with significantly different physical properties for the cap and base. Furthermore, the base must be able to be connected to a tube, which limits the materials that can be used for the base, making it difficult to select a high-hardness material for the cap when welding.

[0062] In the needleless connector of the present disclosure, the base 110 and the cap 120 are connected to each other by a connecting mechanism that connects the base 110 and the cap 120 by fitting an engaging claw into an engaging hole that receives the engaging claw. Therefore, there is no need to weld the base 110 and the cap 120, so the material of the cap 120 can be selected independently of the base 110, and the cap 120 can be formed from a material with a higher hardness than the base 110. A cap 120 formed from a resin with a high hardness can achieve high hardness and strength that makes it resistant to deformation even when a high torque is applied when a prefilled syringe or the like is screwed onto it. Furthermore, because there is a high degree of freedom in the selection of the base 110, it is possible to cause the base 110 to deform appropriately when the cap 120 is fitted, improving assembly ease.

[0063] For example, the base 110 and the cap 120 can be made of rigid vinyl chloride, which is easy to connect to a tube and has a Shore hardness of about 70 to 90, and the cap 120 can be made of polyoxymethylene (POM) with a Rockwell hardness of about 80 to 120. Alternatively, the base 110 can be made of rigid vinyl chloride and the cap 120 can be made of polypropylene (Rockwell hardness: 85 to 100) or high-density polyethylene.

[0064] The hardness of the molded base 110 and the hardness of the cap 120 can be measured by a normal Rockwell hardness test or a test conforming to ISO / TS 19278, and compared.

[0065] In the case of a medical needleless connector, the parts that come into contact with blood, medication, etc. must be made of materials whose safety has been verified, and the materials cannot be freely selected. However, for example, in a configuration such as that shown in Figure 4, in which an inner cylindrical portion 128 is provided inside a cylindrical portion 121 and the inner cylindrical portion 128 tightly contacts and seals with the skirt-shaped portion 174 of the elastic valve body 102, the cap 120, which is the portion outside the elastic valve body 102, does not come into contact with blood, medication, etc. Therefore, if the base 110 and the inner cylindrical portion 128 are made of medical-grade materials whose safety has been verified, the material of the cap 120 can be freely selected.

[0066] In this embodiment, a needleless connector is shown having a configuration in which the base has a first port and a second port in a direction intersecting the insertion port, and a liquid flow path connecting the first port and the second port is provided within the base. However, the configuration is not limited to this, and the characteristic configuration of the present disclosure can be applied to various needleless connectors having an insertion port to which an elastic valve body is attached and to which a coupler is screwed.

[0067] FIG. 7 shows a modified needleless connector. The needleless connector of this modified example has a main body 201 in which a male luer portion 216 is formed. The main body 201 has a base 210 and a cap 120. The cap 120 is substantially the same as the needleless connector according to the previously described embodiment, and has a cylindrical portion 121 to which the elastic valve body 102 is attached and which forms an insertion port into which the male connector is inserted, and a cap-side flange 122 attached to the base end of the cylindrical portion 121. A cylindrical convex portion is provided to protrude from the underside of the cap-side flange 122. Four ribs serving as positioning portions are provided at equal intervals on the bottom side of the cap-side flange 122, and engagement claws 126 protruding radially outward are provided between the four ribs.

[0068] The base 210 of this modified example has a connecting portion 211 to which the cap 120 is connected, a female thread portion 215 that serves as a coupler, and a male luer portion 216. The connecting portion 211 has an inner wall 252, an intermediate wall 253, and a peripheral wall that protrude upward from a flange-shaped portion 218 at the upper end of the female thread portion 215. The inner wall 252 is fitted into the inner cylindrical portion 128 on the cap 120 side, and the upper end of the intermediate wall 253 abuts against the lower end of the skirt-shaped portion of the elastic valve body 102. As with the connecting portion of the previously described embodiment, the peripheral wall has an engaging hole 156 that receives the engaging claw 126 and a groove that receives a rib, and the engaging claw 126 and the rib of the cap 120 can be engaged with each other to connect the cap 120.

[0069] Male luer portion 216 formed on base 210 of this modified example is continuous with the inner cavity of tubular portion 121. By connecting the needleless connector of this modified example to a regular female connector using male luer portion 216 and female thread portion 215, it becomes possible to use the regular female connector as a needleless connector.

[0070] In this modified example, the upper fixing claw 132 that fixes the elastic valve body 102 is formed on the cylindrical portion cap 129 that is separate from the cylindrical portion 121. However, the upper fixing claw 132 may also be formed integrally with the cylindrical portion 121.

[0071] In a configuration in which the inner cylindrical portion 128 is disposed inside the cylindrical portion 121, excessive welding by ultrasonic welding of the cap 120 to the base 110 may result in excessive pressure being applied to the inner cylindrical portion 128, resulting in deformation. The configuration in which the cap 120 and base are fitted and fixed with engaging claws, as shown in this embodiment and its modified examples, can prevent deformation of the inner cylindrical portion 128. Furthermore, the base has four circumferential locking holes, and the peripheral wall forming each locking hole has a notch adjacent to it. This allows the peripheral wall forming each locking hole to flex, allowing the cap 120 and base to be assembled without adversely affecting the elastic valve body 102, such as misalignment. Furthermore, the lower end of the cap circumferentially covers the elastic valve body 102, allowing the valve body flange portion 175 of the elastic valve body 102 to be assembled in a compressed state.

[0072] In this embodiment, a needleless connector having multiple characteristic configurations is shown, but the needleless connector of the present disclosure is not limited to one having all of these characteristic configurations, and it is sufficient if it can solve at least one of the problems associated with conventional needleless connectors. [Industrial Applicability]

[0073] The medical connector of the present disclosure is excellent in safety and is useful as a needleless connector to be connected to an infusion line. [Explanation of symbols]

[0074] 101 Main body 102 Elastic valve body 110 base 111 Connection part 112 Middle section 113 Bottom plate 120 Cap 121 Cylindrical part 122 Cap side flange 124 Cylindrical convex part 125 Ribs 126 Engagement claw 127 Threaded joint 128 Inner cylinder 131 Top opening 132 Upper fixed claw 133 Lower fixing claw 135 Convex 141 First Port 142 Secondary Port 143 Liquid flow path 144 Bulkhead 145 Cavity 151 Top opening 152 Inner wall 153 Intermediate Wall 154 Peripheral wall 155 Groove 156 Engagement hole 161 Side wall 162 Connecting Wall 163 Information Department 171 Central part 171a Slit 172 outer edge 173 Narrow area 174 Hakama-like part 175 Valve body flange 181 Gate Remains 183 Outer Rib 185 Liquid flow path side wall 186 Bulkhead 187 Middle outer wall

Claims

1. The connector includes a main body having an insertion port into which a male connector is inserted, and an elastic valve body that closes the insertion port. the main body portion constitutes the insertion port and includes a cylindrical portion having a threaded portion on a side surface thereof, a cap having a cap-side flange provided at a base end of the cylindrical portion, and a base connected to the cap-side flange; the cap-side flange covers an upper end of the base, and has a positioning portion on a surface of the base that positions the cap-side flange relative to the base in a circumferential direction and a connecting portion that is connected to the base, the base has a positioned portion that engages with the positioning portion and a connected portion that engages with the connecting portion, The connecting portion and the connected portion are configured by an engaging claw and an engaging hole that fit together, the engagement hole is formed by a pair of side walls located on the sides of the engagement claw when the engagement hole is fitted with the engagement claw, and a connecting wall connecting the pair of side walls, A medical connector in which the position where resin flows reunite during molding is shifted from the connection wall, and a weld line occurs at a position different from the connection wall.

2. A medical connector as described in claim 1, wherein the base has a bottom plate formed with a contact surface that contacts the skin in a planar manner, and a cavity that opens to the side.

3. the base has a liquid flow path extending in a direction intersecting the insertion port; The medical connector according to claim 2 , wherein the cavity extends parallel to the fluid flow path.

4. The engagement hole is provided in the base, 2. The medical connector according to claim 1, wherein the base has a liquid flow path extending in a direction intersecting the insertion port, and a bottom plate on which a gate mark is formed in a position that does not overlap with the liquid flow path in a planar view.

5. The engagement hole is provided in the base, 2. The medical connector according to claim 1, wherein the base has a cavity below the engagement hole, and the cavity forms a thin portion on one side of a pair of side walls below the engagement hole.

6. A medical connector as described in claim 1, wherein the hardness of the cap is higher than the hardness of the base.

7. The elastic valve body has a central portion and a skirt-shaped portion formed on the outer periphery of the central portion, the base has an inner cylindrical portion that is in close contact with the inner surface of the skirt-shaped portion, The medical connector according to claim 1 , wherein the tubular portion is in close contact with an outer surface of the skirt-shaped portion.

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