JP7487537B2 - Male connector for enteral nutrition - Google Patents

Description

This disclosure relates to a male connector for enteral nutrition.

There are various types of connections in medical devices. In recent years, with the increase in medical devices, incorrect connection of medical devices has become a major problem. For this reason, new connector standards are being established to prevent incorrect connection of medical devices. Specifically, medical devices are divided into six categories, and connectors are required that cannot connect medical devices of different categories to each other. For example, in the field of nutrition, the standard is to provide a male connector with a male lure at the upstream end on the patient side, and a female connector that accepts the male lure at the downstream end on the supply side. With this standard, the connector provided at the upstream end on the patient side, which was previously a female connector, will be changed to a male connector.

The male connector installed at the upstream end on the patient side may be used for a long period of time, so it is very important to keep it clean. However, in the case of male connectors with couplers, nutrients that leak from the tip of the male lure tend to seep into the gap between the male lure and the coupler. To address this issue, various tools for cleaning the inside of the coupler are being considered.

JP 2015-188522 A JP 2017-099738 A

However, while the method of injecting a cleaning solution between the male lure and the coupler is effective in removing dirt, it has the problem that the installation of the equipment and the cleaning procedure are cumbersome.

The method of inserting a wiping tip between the male lure and the coupler to wipe off dirt is easy to operate, but has the problem of not being able to adequately clean narrow gaps.

Therefore, instead of the conventional idea of cleaning a coupler that has enteral nutrition liquid attached to it after the fact, the inventors have taken a new approach to preventing the adhesion of enteral nutrition liquid to the coupler in the first place. The objective of this disclosure is to realize a male connector for enteral nutrition that can prevent the adhesion of enteral nutrition liquid to the coupler in advance.

The first aspect of the male connector for enteral nutrition has a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side, a male connector body to which a tube is connected on the downstream side, and a coupler that can move between a first position where it can be screwed into the female connector and a second position downstream of the first position where the male luer part is exposed.

Normally, the male connector and female connector are connected by screwing the coupler together to fit the male lure and female lure. In this case, when the male lure is inserted into the female lure during connection, the enteral nutrition liquid overflows from the female lure and enters the coupler. Also, when disconnecting, the liquid inside is scattered due to vibration, impact, etc. during disconnection, and enters the coupler. However, in this embodiment, the coupler can be moved downstream, and the coupler can be moved away from the male lure by moving it to the second position. Therefore, if the user moves the coupler to the second position in advance and then engages the male lure and female lure, the enteral nutrition liquid can be prevented from entering the coupler even if it flows out.

In addition, in this embodiment, cleaning problems do not occur when the male lure part and the coupler rotate relative to each other. That is, when the male lure part and the coupler rotate relative to each other, a small gap is inevitably formed between the male lure part and the coupler. If nutrient liquid adheres to the gap, there is a risk that the nutrient will not be completely removed, so a fixed lock that prevents the male lure part and the coupler from rotating relative to each other has to be adopted. However, in this embodiment, the user can move the coupler to the second position in advance and then engage the male lure with the female lure, so that the coupler can be moved away from the male lure when the male lure and female lure are engaged, and the enteral nutrient liquid can be prevented from entering the coupler.

In the first aspect of the male connector for enteral nutrition, it is preferable that the coupler is capable of restricting movement at least in the second position. With such a configuration, it is possible to prevent the coupler from unintentionally moving from the second position to the first position and becoming contaminated by the enteral nutrition liquid.

In the first aspect of the male connector for enteral nutrition, a cap that closes the opening of the male luer part can be provided, and the cap can have a cap body, a cap connection part having a first end connected to the cap body and a second end connected to the coupler, and a movement limiting part that limits the movement of the coupler in the second position.

In this case, the movement limiting portion may be a cap engaging portion that can engage with the tube, and the movement of the coupler may be limited by engaging the cap engaging portion with the tube. With this configuration, unintended movement of the coupler can be limited, and the cap is less likely to get in the way when not in use. The cap engaged portion may be fitted to the middle of the tube and the cap engaging portion may be engaged with the cap engaged portion to limit the movement of the coupler. Since tubes have various outer diameters, the cap engaging portion may be manufactured for each outer diameter, but the cap engaging portion may be standardized to engage only with the mainstream outer diameter. The cap engaging portion may be a separate member from the cap that is connected to the cap.

In a first aspect of the male connector for enteral nutrition, the connector further includes a cap that closes the opening of the male luer portion, the cap having a cap body and a cap connection part having a first end connected to the cap body, the cap connection part having a second end attached to the male connector body or tube, and when the coupler is in the second position, at least a portion of the cap connection part is located within the lumen of the coupler, the first end is located downstream of the coupler, and the second end is located upstream of the coupler.

The connector may further include a cap that closes the opening of the male luer portion, the cap having a cap body, a cap connection portion having a first end connected to the cap body and a second end assembled to the male connector body or tube, and a movement limiting portion that limits the movement of the coupler.

These configurations limit unintended movement of the coupler and the range of movement of the coupler, and the cap is less likely to get in the way when not in use. The second end of the cap connection part may be, for example, a ring, which may be fitted into the male connector body or rotatably engaged. In addition, a protrusion may be provided on the male connector body to restrict the second end of the cap connection part from moving downstream beyond a predetermined range, in which case the second end of the cap connection part may move axially within the predetermined range.

In the first aspect of the male connector for enteral nutrition, a cap that closes the opening of the male lure part may be further provided, and the cap may be configured so that the opening of the male lure part cannot be closed when the coupler is in the first position. With this configuration, the user can be guided to move the coupler to the second position to insert or remove the male lure part.

In the first aspect of the male connector set for enteral nutrition of the present disclosure, a cap that engages with the male lure part is further provided, the cap having a gripping part that is gripped to release the engagement with the male lure part, and when the cap engages with the male lure part and the coupler is in the first position, the gripping part is housed within the coupler, and the gripping part may be exposed by moving the coupler to the second position. With this configuration, the coupler is moved to the second position when the cap is removed, and the user can be guided to place the coupler in the second position when inserting the male lure part into the female connector.

In the first embodiment of the male connector for enteral nutrition, the coupler has a side slit that can hold the tube. With this configuration, the coupler can be temporarily fixed in a position away from the male lure.

In the first embodiment of the male connector for enteral nutrition, the coupler has a side slit that extends from the upstream end to the downstream end. This configuration allows the coupler to be spaced away from the male lure.

In the first aspect of the male connector for enteral nutrition, the coupler has a downstream extension, and the axial dimension of the coupler can be 75% or more of the axial dimension of the male connector body. With this configuration, the user can be guided to grasp the coupler rather than the male connector body when disconnecting the coupler from the female connector, and the user can reduce the possibility of rotating the female connector body and the male connector body relative to each other before moving the coupler to the second position.

In a first aspect of the male connector for enteral nutrition, the coupler has an upstream extension, which may extend axially toward the upstream side so that the coupler covers 70% or more of the axial dimension of the female connector when the coupler and the female connector are screwed together. This configuration reduces the possibility of the female connector and the male connector body rotating relative to each other before the user moves the coupler to the second position when disconnecting the female connector.

In the first aspect of the male connector set for enteral nutrition disclosed herein, an indicator may be provided to indicate that the user should move the coupler to the second position before engaging or disengaging the male connector body and the female connector. This configuration can prevent the nutrient solution from entering the coupler.

In the first aspect of the male connector set for enteral nutrition, the male connector body has a body gripping portion provided downstream of the male lure portion, and the body gripping portion can have an axial cross-sectional shape different from that of the male lure portion. This configuration improves operability.

In a first aspect of the male connector set for enteral nutrition, the male connector body has a body gripping portion provided downstream of the male lure portion, and the body gripping portion is hidden within the coupler when the coupler is in the first position, and can be made exposed by moving the coupler to the second position. With this configuration, when inserting or removing the male lure portion, the user can be guided to move the coupler to the second position to expose the body gripping portion, which is easy to grip.

In each embodiment of the male connector for enteral nutrition disclosed herein, the male connector for enteral nutrition may be housed in a package with the coupler fixed in the second position where the male lure portion is exposed. With this configuration, the user can be guided to engage the male lure with the female lure at a position where the coupler is away from the male lure.

The second aspect of the male connector for enteral nutrition is equipped with a male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a connection part on the downstream side that can connect to a catheter to be inserted into a body cavity, and a coupler that can move between a first position where it can be screwed into the female connector and a second position that is closer to the catheter than the first position and where the male luer part is exposed.

The downstream side of the catheter is inserted into the patient's body cavity, and a portion of the upstream side is exposed from outside the body cavity. A male connector is provided at the upstream end, and the catheter is left in place with the upstream end exposed to the outside for a period ranging from a few days to up to a year. For this reason, the male connector is required to be kept constantly clean. With this embodiment, it is possible to keep the male connector constantly clean.

The male connector for enteral nutrition disclosed herein can easily prevent enteral nutrition liquid from adhering to the gap between the coupler and the male lure part.

FIG. 2 is a cross-sectional view showing the male connector for enteral nutrition according to the first embodiment. FIG. 2 is a side view showing a state in which the coupler of the male connector for enteral nutrition according to the first embodiment is in a second position. FIG. 2 is a side view showing a state in which the coupler of the male connector for enteral nutrition according to the first embodiment is connected to the female connector in a first position. 1A to 1D are plan views showing examples of the cap. FIG. 1 is a plan view showing a package for male connectors for enteral nutrition having a male connector for enteral nutrition according to a first embodiment. FIG. 11 is a cross-sectional view showing a male connector for enteral nutrition according to a first modified example of the first embodiment. FIG. 11 is a side view showing a state in which the coupler of the male connector for enteral nutrition according to the first modified example of the first embodiment is in a second position. 13 is a perspective view showing a state in which a coupler is in a first position in a modified example of the cap. FIG. 13 is a perspective view showing a state in which the coupler is in a second position in a modified example of the cap. FIG. 13 is a side view showing a state in which the coupler is in a second position in the second modified example of the cap. FIG. FIG. 11 is a cross-sectional view showing a third modified example of the cap. FIG. 13 is a cross-sectional view showing a coupler having a downstream extension. FIG. 11 is a side view showing a modified example of the downstream extension portion. FIG. 13 is a cross-sectional view of a coupler having an upstream extension. FIG. 11 is a side view showing a male connector for enteral nutrition according to a second modified example of the first embodiment. FIG. 13 is a side view showing a coupler of a male connector for enteral nutrition of a second modified example. FIG. 11 is a cross-sectional view showing a male connector for enteral nutrition according to a third modified example of the first embodiment. FIG. 13 is a side view showing a state in which the coupler of the male connector for enteral nutrition according to the third modified example of the first embodiment is in a second position. FIG. 13 is a side view showing a state in which the cap of the male connector for enteral nutrition according to the third modified example of the first embodiment is removed.

As shown in Figs. 1 to 3, the male connector 100A for enteral nutrition according to the first embodiment includes a male connector body 101 and a coupler 103. The male connector body 101 includes a male lure part 111 that is inserted into the upstream female connector 300, and a connection part 112 to which a flexible catheter 200 that is inserted into the body cavity of the patient (downstream side) can be connected. The upstream end of the catheter 200 is fixed to the connection part 112 and exposed outside the body cavity. The downstream side of the catheter 200 is inserted into the body cavity of the patient, and the nutrient liquid can flow out from the side hole, which is an opening formed at the downstream end, to the stomach and intestines. The coupler 103 is cylindrical and has a female thread 135 that can be screwed with a male thread 311 provided on the outer surface of the female connector 300, and can move between a first position where it can be screwed with the male thread 311 of the female connector 300, and a second position downstream of the first position where the male lure part 111 is exposed. The coupler can move on the catheter exposed to the outside between the male luer portion and the patient (e.g., the patient's abdomen). The enteral nutrition male connector is not limited to being directly fixed to the catheter 200. It is also possible to further assemble the enteral nutrition male connector to the connector assembled to the catheter 200. Also, the enteral nutrition male connector can be provided on an extension tube that connects the gastrostomy button placed in the body cavity to the container.

In the male connector for enteral nutrition 100A of this embodiment, the coupler 103 can be moved between a first position and a second position where the male lure part 111 is exposed. Therefore, as shown in FIG. 2, the coupler 103 can be moved to the second position to expose the male lure part 111, and then the male lure part 111 can be inserted into the female connector 300. Even if the enteral nutrition liquid overflows during insertion, the enteral nutrition liquid rarely adheres to the inside of the coupler 103 located downstream. In addition, since the male lure part 111 is exposed, the overflowing enteral nutrition liquid can be easily wiped off even when the male lure part 111 is inserted into the female connector 300. After wiping off the enteral nutrition liquid, if the coupler 103 is moved to the first position, the coupler 103 can be engaged and locked with the female connector 300 without the enteral nutrition liquid adhering to the inside of the coupler 103.

When disconnecting the connectors, first, the coupler 103 and the female connector 300 are disengaged, and the coupler 103 is moved to the second position. Next, the male luer part 111 is pulled out from the female connector 300. In this way, even if the enteral nutrition liquid spills out when the male luer part 111 is pulled out from the female connector, it can be easily wiped off because the male luer part 111 is exposed. In addition, because the coupler 103 is separated from the upstream end of the male luer part 111, the spilled enteral nutrition liquid rarely gets inside the coupler 103.

The second position may be any position where the male luer part 111 is exposed and can be wiped off, but it may also be a position where the male connector body 101 further downstream is completely exposed. In this case, by slightly bending the catheter 200 at the second position, the axial direction of the male connector body 101 and the axial direction of the coupler 103 can be easily shifted. By shifting the axial direction of the male connector body 101 and the axial direction of the coupler 103 and inserting and removing the male luer part 111, it is possible to make it even more difficult for the overflowing enteral nutrition liquid to enter the coupler 103.

The male connector for enteral nutrition 100A of this embodiment has a cap 105 that closes the opening of the male luer part 111. As shown in FIG. 4(a), the cap 105 has a cap body 151 and a cap connection part 152 that connects the cap body 151 and the coupler 103. The outer edge of the cap body 151 is provided with a cap engagement part 155 that can engage with the catheter 200. The cap engagement part 155 is a protruding piece that protrudes from the cap body 151 and has a notch 156 that engages with the catheter 200.

The cap engagement portion 155 is formed of a material that is more flexible than the catheter. Therefore, when the catheter 200 is clamped and fixed in the notch 156, the catheter is less likely to become blocked. The cap engagement portion 155 functions as a movement limiting portion that removably fixes the cap body 151 to the catheter 200. When the cap body 151 engages with the catheter 200, the relative movement of the coupler 103 connected to the cap body 151 by the cap connection portion 152 with respect to the catheter 200 is also limited. If the cap engagement portion 155 is fixed to the catheter 200 with the coupler 103 moved to the second position, the coupler 103 is substantially fixed to the second position.

By being able to fix the coupler 103 in the second position, it is possible to prevent the coupler 103 from unintentionally moving upstream when inserting or removing the male luer portion 111, which would cause the enteral nutrition liquid to seep into the coupler 103.

The cap engagement portion 155 can also be as shown in Figures 4(b) to (d). As shown in Figure 4(b), by providing multiple notches 156 of different sizes at different positions, it is possible to accommodate various catheters 200 with different diameters. Also, as shown in Figure 4(c), multiple parts with different diameters may be provided in one notch 156. Also, instead of providing a circular part as shown in Figure 4(d), multiple projections and recesses can be provided. The width of the notch 156 can be adjusted so that it can engage with the catheter 200 without coming off and so as not to block the catheter 200.

The cap engagement portion 155 can be provided, for example, on the cap connection portion 152 as long as it can fix the position of the cap 105. The cap engagement portion 155 may also be a separate member that is detachable from the cap body 151. Note that the protruding piece-shaped cap engagement portion 155 provided on the cap body 151 is an integral member with the cap body 151, and therefore can also be used as a pull tab that is pulled with the fingers when removing the cap body 151 from the coupler.

In this embodiment, the movement limiting portion is the cap engaging portion 155 that engages with the catheter 200, but the movement limiting portion is not limited to this configuration. For example, a ring-shaped member having a solid rod-shaped body extending in a direction perpendicular to the axis of the catheter 200 can be fitted onto the catheter 200 at a predetermined position, and the rod-shaped body can be connected to the notch 156 of the cap engaging portion.

In this embodiment, the cap body 151 has a convex outer edge that fits over the upstream opening of the coupler 103, and a convex central portion that fits over the male luer portion 111. In this way, the cap body 151 can securely close the opening of the male luer portion 111 and is less likely to come off accidentally.

In this embodiment, the cap connection part 152 that connects the cap body 151 and the coupler 103 has a first end connected to the cap body 151 and is formed integrally with the cap body 151. The second end of the cap connection part 152 is a ring-shaped part 154, and can be connected to the coupler 103 by fitting the ring-shaped part 154 into the annular groove 133 provided at the downstream end of the coupler 103.

In this embodiment, the cap body 151, the cap connection part 152, and the cap engagement part 155 that constitute the cap 105 are integrally formed from a flexible material. However, the cap 105 can also be formed by combining multiple molded parts. In addition, the connection between the cap connection part 152 and the coupler 103 is not limited to the method using the ring-shaped part 154, and various other methods can be used.

When the catheter 200 to which the male connector 100A for enteral nutrition of this embodiment is connected is shipped, that is, when packaged in the packaging 250, the cap engagement portion 155 can be in a state where it is engaged with the catheter 200 as shown in FIG. 5. By packaging in such a unique state, the user can be guided to insert the male luer portion 111 into the female connector with the coupler 103 in the second position.

In this embodiment, the male connector body 101 has a flange portion 115 downstream of the male lure portion 111, and the coupler 103 has a large diameter portion 131 having an inner diameter larger than that of the flange portion 115, and a small diameter portion 132 located downstream of the large diameter portion 131 and having an inner diameter smaller than that of the flange portion 115. The upstream end of the small diameter portion 132 abuts against the flange portion 115 at the first position so that the coupler 103 does not move upstream beyond the first position. Any mechanism may be used to prevent the coupler 103 from moving upstream beyond the first position, and may be achieved by a method other than providing the flange portion 115.

A weak fit mechanism can be provided to prevent the coupler 103 from loosening when the coupler 103 is screwed into the female connector. The weak fit mechanism can be realized, for example, by tapering the outer surface of the male connector body 101 or by adjusting the dimensions of the inner surface of the coupler 103, but it may also be realized by other methods. Note that even in the first position, the coupler 103 can freely rotate around the male connector body 101.

6 and 7 show the male connector for enteral nutrition 100B according to the first modified example. In the modified male connector for enteral nutrition 100B, the second end 158 of the cap connection part 152 is connected to the male connector body 101 instead of the coupler 103, and the second end 158 is assembled to the male connector body 101. Therefore, when the coupler 103 is moved to the second position, the cap connection part 152 passes through the inner cavity of the coupler 103, and the first end 157 is located downstream of the coupler 103, and the second end 158 is located upstream of the coupler 103. Since the cap body 151 cannot pass through the coupler 103, the coupler 103 is restricted from moving downstream beyond the length of the cap connection part 152. In addition, the part of the cap connection part 152 passing through the inner cavity of the coupler 103 becomes a resistance when the coupler 103 moves upstream from the second position. Therefore, the cap body 151 and the cap connection part 152 of the cap 105B function as a movement limiting part that limits the movement of the coupler 103 in the second position.

In this modified example, a ring-shaped portion 154 is provided on the second end 158 of the cap connection portion 152, and the ring-shaped portion 154 is fitted into an annular groove 113 provided on the downstream side of the male connector body 101. The second end 158 of the cap connection portion 152 is assembled to the male connector body 101. In a state where no force is applied, the cap connection portion 152 extends in a direction intersecting the axial direction of the male connector body 101. In addition, since the cap connection portion 152 is formed from a flexible resin, a resilient force is generated when it is bent downstream along the axis of the male connector body 101.

The inner diameter of the small diameter portion 132 of the coupler 103 is slightly larger than the sum of the outer diameter of the catheter 200 and the thickness of the cap connection portion 152, but the cap connection portion 152 presses the coupler 103 due to the elastic force caused by bending the cap connection portion 152 downstream. As a result, the coupler 103 generates a resistance that allows it to be moved by hand but not by gravity, preventing it from moving unintentionally from the second position to the first position.

As shown in FIG. 7, when the coupler 103 is moved to a position where the male connector body 101 is completely exposed, it is preferable that the cap connection part 152 bends in a bow shape upstream of the coupler 103. Specifically, it is preferable that, in the direction perpendicular to the axis, the distance from the central axis of the male connector body 101 to the position of the cap connection part 152 farthest from the male connector body 101 is greater than the distance from the central axis of the male connector body 101 to the outer edge at the upstream end of the coupler 103. With this configuration, it is possible to prevent the coupler 103 from moving upstream.

In this modified example, the length from the central axis to the cap connection part 152 is made longer than the length from the central axis to the coupler to suppress the movement of the coupler upstream, but this is not limited to the above. For example, the cap connection part may be provided with a convex, the material of the cap connection part or the coupler may be adjusted to provide a friction increasing part, or the dimensions may be adjusted to make it difficult for the coupler to move to the first position. The second end 158 of the cap connection part 152 is assembled to the annular groove 113 of the male connector body 101 by the ring-shaped part 154, but the second end 158 may be assembled to the male connector body 101 by any method. The second end 158 may also be assembled to the catheter instead of the male connector body 101. For example, the ring-shaped part 154 may be frictionally engaged with the catheter 200. A hard connection member may also be fitted to the catheter 200, and the ring-shaped part 154 may be fitted to the connection member. The second end 158 does not need to be fixed so that its axial position relative to the male connector body 101 does not change at all; it can be fixed so that its axial position changes slightly.

8 and 9 show a cap 105C of a first modified example in which a return stopper 159 for restricting unintended movement of the coupler 103 from the second position to the first position is provided on the cap connection part 152. The return stopper 159 is a ring-shaped part provided in the middle part of the cap connection part 152. The return stopper 159 is wider than other parts of the cap connection part 152 and can be elastically deformed. In a non-deformed state, the return stopper 159 is wider than the small diameter part 132 of the coupler 103 and cannot pass through the small diameter part 132, but can pass through the small diameter part 132 by compressing and deforming it. The outer diameter of the return stopper 159 in a non-deformed state is set so that when it is housed in the coupler 103, it abuts against two points on the inner wall of the large diameter part 131 and lightly presses and catches. As a result, the return stopper 159 functions as a movement limiting part that restricts the movement of the coupler 103, making it less likely that unintended movement of the coupler 103 will occur.

By making the outer diameter of the detent portion 159 into a cornerless circular or elliptical shape, the effect of making deformation and restoration easier is obtained. However, it can also be made into a shape with corners, such as a square or hexagonal shape. By having corners, it becomes easier to catch on the inner surface of the large diameter portion 131 having the female thread 135, which has the effect of making it more difficult for unintended movement of the coupler 103 to occur. Furthermore, it is possible to further provide a convex portion so that it has corners and corners so that it becomes easier to catch on the inner surface of the large diameter portion 131.

By making the return stop portion 159 a hollow ring-like portion, it can be made to deform significantly when compressed, making it easier for the small diameter portion 132 to pass through when it is deformed, and also easier to prevent the small diameter portion 132 from passing through when it is not deformed. However, instead of providing a hollow portion on the inside, it may be formed into a plate-like portion, and the plate-like portion may be deformed to bend, allowing the small diameter portion to pass through.

The detent portion 159 can also be a thick portion that is elastically deformable in the cap connection portion 152. For example, a spherical deformable member can be provided in the middle of the cap connection portion 152 to engage with the small diameter portion 132. The detent portion can also be a whisker- or rod-shaped elastically deformable member that protrudes in the thickness or width direction from the cap connection portion 152. In this case, the detent portion can be positioned inside the coupler to make it difficult for the coupler to move relative to the axial direction, or can be positioned upstream of the coupler 103 to abut against the upstream end of the coupler 103 and restrict the upstream movement of the coupler 103.

9, the male connector body 101A has a body gripping portion 116 between the annular groove 113 that connects the flange portion 115 and the ring portion 154. The axial cross section of the male connector body 101A where the body gripping portion 116 is formed has a shape different from the axial cross section of the male lure portion. In FIG. 9, the body gripping portion 116 has an axial cross section that is approximately square, and two gripping surfaces 117, which are curved surfaces recessed radially inward, are provided at opposing positions, making it easy to grip with fingers. In addition, when the coupler 103 is in the first position, the body gripping portion 116 is hidden inside the coupler 103, and is exposed by moving the coupler 103 to the second position. Therefore, when inserting or removing the male lure portion 111 into or from the female connector 300, the user can be guided to move the coupler 103 to the second position to expose the gripping portion 116.

(0156)
The main body gripping part 116 is preferably provided downstream of the male luer part 116, in a position where it is hidden when the coupler 103 is in the first position and exposed when the coupler 103 is moved to the second position, but may be provided anywhere downstream of the male luer part 111. The main body gripping part 116 may have any shape that is easy to grip, and may be a non-circular shape in a cross section perpendicular to the axis. For example, it may be an ellipse or a rectangle. The gripping surface 117 may be a flat surface instead of a curved surface.

The cap 105D of the second modified example shown in FIG. 10 has a cap body 151 and a cap connection part 152 whose first end is connected to the cap body 151 and whose second end is assembled to the tube 200 by a ring-shaped part 154A. The cap body 151 is provided with a cap engagement part 155 that engages with the tube 200, and the cap engagement part 155 can engage with a position upstream of the coupler 103 with respect to the assembly position of the second end when the coupler 103 is moved to the second position. Therefore, the cap connection part 152 and the cap engagement part 155 of the cap 105D can function as a movement limiting part that limits the movement range of the coupler 103 between the second end and the first end of the cap connection part 152.

In this modified example, the cap engaging portion 155 is provided on the cap body 151, but the cap engaging portion 155 can also be provided on the cap connecting portion 152. The cap engaging portion 155 can be engaged with the connector body 101 instead of the tube 200. The cap engaging portion 155 can also be engaged with the coupler 103. In this modified example, the ring-shaped portion 154A frictionally engages with the tube 200. However, the ring-shaped portion 154A can also be bonded or heat-sealed to the tube 200. The second end of the cap connecting portion 152 can also be fixed directly to the tube 200 without using the ring-shaped portion 154A. Depending on the length of the male connector body 101, the second end of the cap connecting portion 152 can also be fixed to the male connector body 101.

In the first position, the cap body 151 cannot be attached to the male luer part 111, so that the user can be guided to insert or remove the male luer part 111 from the female connector 300 while the coupler 103 is in the second position in terms of the method of connecting the connector. For example, as shown in FIG. 11, a third modified cap 106 can be used in which the cap body 151 has a bell-shaped outer edge part 162 that fits onto the coupler 103, and a central protrusion part 161 that protrudes from the outer edge part 162 and fits onto the male luer part 111.

The central convex portion 161 is shaped to engage with the male luer portion, but at least a portion of the inner cavity of the outer edge portion 162 is sized smaller than the outer surface of the coupler. Therefore, even if the central convex portion 161 is attempted to engage with the male luer portion 111 when the coupler 103 is in the first position, the inner cavity of the outer edge portion 162 collides with the coupler 103, and the central convex portion 161 cannot be moved to a position where the central convex portion 161 and the male luer portion 111 engage. In this way, the male luer portion 111 cannot be fitted onto the male luer portion 111 unless the male luer portion 111 is covered by the coupler 103, so when the cap 106 is attached, the coupler 103 is always in a position that exposes the male luer portion 111.

The length of the cap connection part 152 is adjusted so that when the coupler 103 is in the first position, the male connector end cannot be inserted, and when the coupler 103 is in the second position, the male connector end can be inserted. That is, the length from the first end to the second end of the cap is smaller than the length from the second end of the cap to the tip of the male lure part 111, and when the coupler 103 is in the first position, the maximum outer diameter of the male connector end is the coupler, so the cap cannot be placed over the male connector end. Therefore, when the user removes the cap 106, the coupler 103 is naturally in the second position where the male lure part 111 is exposed, and when closing the opening of the male lure part with the cap, the coupler cannot be closed unless the coupler is in the second position, so the user can be guided to move the coupler to the second position and then close the cap.

In this embodiment, there are two mechanisms that prevent the cap from engaging with the male luer part when the coupler is in the first position: a mechanism based on the dimensions of the coupler's outer surface relative to the outer edge, and a mechanism based on the length of the cap connection part, but only one of these mechanisms may be used. Furthermore, the engagement between the cap and the male luer part is not limited to the engagement between the inner surface of the cap and the outer surface of the male luer, but may also be the engagement between the cap and the inner surface of the male luer part. For example, a protrusion that engages with the inner surface of the male luer part may be provided on the bottom of the cap, and the cap and the inner surface of the male luer part may be engaged.

A downstream extension 141 may be provided downstream of the coupler 103 to guide the coupler 103 to the second position when the male lure part 111 is inserted or removed. In FIG. 12, the downstream extension 141 covers the male connector body 101 so that no force can be applied to the male connector body 101 when the coupler 103 is in the first position. This makes it difficult to insert or remove the male lure part 111 from the female connector 300 without moving the coupler 103 to the second position. It is preferable that the downstream extension 141 completely covers the downstream end of the male connector body 101 when the coupler 103 is in the first position, but the downstream end of the male connector body 101 may be slightly exposed as long as it cannot be operated by pinching it with fingers. Specifically, it is preferable that the axial dimension of the coupler 103 including the downstream extension 141 is 75% or more of the axial dimension of the male connector body 101. The downstream extension only needs to make it difficult to grip the male connector body, and is not limited to covering the entire circumference of the male connector body. For example, the downstream extension may have a slit or hole formed therein. It is also not limited to being cylindrical, and may be in the form of a protruding piece. It is preferable for the coupler to cover 70% or more of the surface area of the male connector body.

As shown in Figs. 13(a) and (b), the enteral nutrition male connector set may be provided with a display on the downstream extension 141 to encourage the coupler 103 to move to the second position when attaching or detaching. In Fig. 13(a), the display section displays text to slide the coupler when attaching or detaching the connector. In Fig. 13(b), numbers indicating the order of work and arrows indicating the work are displayed. In this way, even if the coupler is packed in a state where it is fixed in the first position via a weak fitting mechanism or the like, the user can recognize the work to be done first from the display, and can be guided to connect the connector after moving the coupler to the second position. Note that even if the downstream extension 141 is not provided on the coupler 103, a display encouraging the movement to the second position may be provided. The display encouraging the movement can be provided on the coupler 103, but it can also be provided on the catheter 200. In this way, it is possible to clearly indicate to the user that a different operating method, that is, mating or disengaging of the male lure and the female lure, is to be performed after the coupler is moved to the second position, and it is possible to guide the user to perform the correct operating method of the present invention. Note that the display unit that shows the user that mating or disengaging of the male lure and the female lure is to be performed after the coupler is moved to the second position is not limited to being integrated with the male connector for enteral nutrition as shown in FIG. 13, but may be, for example, an operating instruction manual enclosed in the packaging material or an attached document.

As shown in FIG. 14, an upstream extension 142 may be provided on the upstream side of the coupler 103. When the connector is released, the upstream extension 142 covers the upstream side of the female connector 300 when the screw engagement between the coupler 103 and the female connector is released. The upstream extension 142 makes it difficult for the user to grasp the female connector, so the user naturally tries to move the position of the coupler 103, and can be guided to move the coupler 103 to the second position. In addition, when the connector is connected, the upstream extension 142 makes it difficult to grasp the female connector 300, so it is also difficult to insert the male lure part 111 into the female connector 300. Therefore, the user can be guided to insert and remove the male lure part 111 into and from the female connector 300 with the coupler 103 moved to the second position. The engagement between the coupler 103 and the female connector 300 is released by rotating the coupler 103 by holding the downstream end of the male connector body 101 or the catheter.

When the coupler 103 including the upstream extension 142 is screwed with the female connector 300, it is preferable that the coupler 103 covers 70% or more of the axial dimension L2 of the female connector 300, and the length L1 of the part of the coupler 103 including the upstream extension 142 that accommodates the female connector can be set to L2 or more so that the female connector 300 is completely covered in the axial direction. Note that the upstream extension need only make it difficult to grip the female connector 300, and is not limited to covering the entire circumference of the female connector 300. For example, a slit or hole may be formed in the upstream extension. Also, it is not limited to a cylindrical shape, and a protruding shape may be adopted. The coupler 103 preferably covers 50% or more of the surface area of the female connector.

As shown in Figures 15 and 16, a coupler 103 with a slit 143 can also be used. In the male connector for enteral nutrition 100C, the slit can hold the catheter, and the coupler can be fixed in the second position through the slit. The slit also reaches from the upstream end to the downstream end, allowing the catheter 200 to pass through. Therefore, when the coupler 103 is moved downstream of the male connector body 101, the coupler 103 can be removed from the catheter 200. With this configuration, the coupler can be moved away from the male lure portion when the connector is connected. Also, if the inside of the coupler 103 becomes dirty, the coupler 103 can be removed and washed, or replaced with a new coupler 103. If the width of the slit 143 is adjusted so that the catheter 200 can be clamped and fixed, the movement of the coupler 103 can be restricted in the second position.

The slit does not have to reach from the upstream end to the downstream end, and various shapes can be adopted for the slit shape, similar to the notch of the cap engagement portion shown in FIG. 4. Also, the slit that reaches from the upstream end to the downstream end may extend in a direction that is inclined to the axial direction, rather than extending straight in the axial direction. Furthermore, the extension direction of the slit may be stepped or may be different between the upstream side and the downstream side, making it difficult for the coupler to come off the catheter unintentionally, and also making it possible to remove the coupler.

As a method for encouraging the coupler 103 to move to the second position when attaching or detaching, a cap 170 as shown in Figs. 17 to 19 can be provided. The cap 170 used in the enteral nutrition male connector 100D according to the third modified example has a top surface portion 171 that closes the upstream end opening of the male luer portion 111, and a tubular portion 172 that fits around the male luer portion 111. The base end of the tubular portion 172 is provided with a male thread 173 that screws into the female thread 135 provided on the coupler 103. The top surface portion 171 is provided at the upstream end of the tubular portion 172, has a shorter axial length than the tubular portion 172, is shaped to be more difficult to grip than the tubular portion 172, and has a smooth outer surface without any irregularities or steps.

When the enteral nutrition male connector 100D of this modified example is not connected to the female connector 300 and is not in use, a cap 170 is attached to cover the male luer part 111. As shown in FIG. 17, when the coupler 103 is placed in the first position with the tubular part 172 engaged with the male luer part 111, the tubular part 172 is housed within the coupler 103 and only the top surface part 171 is exposed on the upstream side of the coupler 103.

The male connector 100D for enteral nutrition of this modified example has a top surface 171 that is difficult to grasp, and the cylindrical portion 172 that is easier to grasp is housed inside the coupler 103. Therefore, when connecting the male connector 100D for enteral nutrition of this modified example to the female connector 300 provided upstream, the user is guided to perform the following operations.

First, as shown in FIG. 18, the coupler 103 is moved to a second position downstream of the first position to expose the tubular portion 172. Next, the exposed connection portion 112 and the tubular portion 172 are grasped and pulled with separate hands, and the cap 170 is removed as shown in FIG. 19. Next, while grasping the connection portion 112, the male luer portion 111 is inserted into the female connector 300. After this, the coupler 103 is moved to the first position and screwed into the male thread 311. By operating in this manner, even if the enteral nutrition liquid overflows when the male luer portion 111 is inserted, the enteral nutrition liquid is hardly attached to the inside of the coupler 103 located downstream. In addition, since the male luer portion 111 is exposed, the overflowing enteral nutrition liquid can be easily wiped off even when the male luer portion 111 is inserted into the female connector 300.

The top surface portion 171 may have any shape that is difficult to grip. In this embodiment, the top surface portion 171 has a short axial length, and its outer surface does not have any protrusions or steps that would make it easier to grip. For this reason, it is difficult to grip the top surface portion 171, and the user can be guided to move the coupler 103 to the second position to expose the cylindrical portion 172, rather than attempting to remove the cap 170 when the cylindrical portion 172 is not exposed.

When the coupler 103 is located at the upstream end of the male connector, the outer edge of the top surface 171 does not protrude radially outward from the coupler 103, and the downstream end surface 175 of the top surface 171 and the tip of the coupler 103 abut against each other, and no gap is generated between the top surface 171 and the coupler 103. Therefore, the downstream end surface 175 of the top surface 171 is covered by the coupler 103 and is not exposed. By making it in this shape, it is difficult to hook a finger or nail between the top surface 171 and the coupler 103 and pull it unless the coupler 103 is moved downstream. This makes it possible to further increase the effect of guiding the user to expose the cylindrical portion 172. That is, when removing the cap and connecting to a female connector, the user is guided to move the coupler 103 to the downstream end of the male connector, and the connection to the female connector can be easily performed with the coupler 103 separated downstream.

In this modified example, the tubular portion 172 has a longer axial length than the top surface portion 171. Therefore, the tubular portion 172 is easier to grip than the top surface portion 171. In addition, the downstream end surface 175 of the top surface portion 171 is a stepped portion that rises radially outward, and when the tubular portion 172 is gripped, the fingers can be placed on the downstream end surface 175, making it easy to apply force. Therefore, the user can be more strongly guided to move the coupler 103 to the second position to expose the tubular portion 172 and the downstream end surface 175 of the top surface portion 171, which are easy to grip. The axial length of the tubular portion 172 is preferably longer from the viewpoint of ease of gripping, and is preferably 1/5 or more, more preferably 1/2 or more, of the length from the upstream end of the male lure portion 111 to the flange portion 115, and the tubular portion 172 can cover the entire area from the upstream end of the male lure portion 111 to the flange portion 115. In terms of specific values, the axial length of the cylindrical portion 172 is preferably about 3 mm to 15 mm, and more preferably about 7 mm to 15 mm.

From the viewpoint of making it easier to remove the cap 170 by exposing the downstream end surface 175 of the cylindrical portion 172 and the top surface portion 171 than when they are not exposed, it is preferable that the axial length of the exposed portion of the top surface portion 171 is short. For example, by making it shorter than the cylindrical portion 172, it is possible to induce the cylindrical portion 172, which is longer and easier to grip, to be exposed. In addition, from the viewpoint of strengthening the impression that it is difficult to grip and strongly inducing the cylindrical portion 172 and the downstream end surface 175 to be exposed, it can be preferably 1/2 or less, more preferably 1/4 or less, of the axial length of the large diameter portion 131 of the coupler 103. The axial length of the exposed portion of the top surface portion 171 is preferably 1/2 or less, more preferably 1/4 or less, of the axial length of the cylindrical portion 172. As a specific numerical value, the axial length of the exposed portion of the top surface portion 171 is preferably 3 mm or less, more preferably 1 mm or less. However, if the outer surface of the top surface 171 is a smoothly curved surface with a constant curvature, such as a hemisphere, it will be difficult to grip even if the axial length of the top surface 171 is long, and the cylindrical portion 172 and downstream end surface 175 can be guided to be exposed.

In this modified example, a male thread 173 is provided on the outer surface of the cylindrical portion 172, and in the first position, the female thread 135 of the coupler 103 and the male thread 173 are screwed together. Therefore, when attempting to remove the cap 170 with the coupler 103 in the first position, the top surface portion 171 must be grasped and rotated while being pulled upstream. This type of action is more difficult than a simple pulling action, and the user can be strongly urged to first disengage the coupler 103 from the cap 170 and then move the coupler 103 to the second position.

The screwing force between the female thread 135 and the male thread 173 is set to be weaker than the frictional engagement force between the tubular portion 172 and the male luer portion 111. For this reason, releasing the screwing by rotating the coupler 103 relative to the cap 170 is much easier than gripping and pulling the top surface portion 171, and the user is guided to move the coupler 103 to the second position.

However, the cap 170 can be engaged with the coupler 103 by a method other than the male thread 173. For example, a convex portion that abuts and frictionally engages with the inner surface of the coupler 103 can be provided on the outer surface of the cylindrical portion 172. Also, the top surface portion 171 can be configured to lightly fit inside the coupler 103. The engagement force between the cap 170 and the coupler 103 is set to be smaller than the engagement force between the cap 170 and the male lure portion 111, so that the coupler 103 can be moved to the second position with the cap 170 and the male lure portion 111 engaged.

In addition, if the coupler 103 and the main body 101 are engaged in the first position to restrict the movement of the coupler 103, the cap 170 and the coupler 103 may not be engaged.

A mechanism can also be provided to hold the coupler 103 in the second position when the coupler 103 is moved to the second position. In this way, it is possible to prevent the coupler 103 from unintentionally moving upstream from the second position when the male luer portion 111 is inserted into the female connector 300.

In addition, a band can be provided to connect the top surface portion 171 to the main body portion 101, the coupler 103, or the tube 200 to prevent the cap 172 from being lost when the cylindrical portion 172 and the male luer portion 111 are not engaged.

In this modified example, the downstream end surface 175 of the tubular portion 172 and the top surface 171 function as a gripping portion to be gripped when removing the cap 170 from the male luer portion 111. However, if the length of the tubular portion 172 is made sufficiently long or if the surface is provided with irregularities to make it easier to grip, a configuration can be created in which no step is created between the tubular portion 172 and the top surface 171. Also, the tubular portion 172 can be shortened so that the step can be hooked with a finger and pulled.

The various male connector bodies, couplers, and caps shown in each embodiment and modification can be interchanged or combined as appropriate.

In each embodiment and modification, an example is shown in which the male connector for enteral nutrition is connected to the upstream end of the catheter introduced into the patient's body, but the connector can be used broadly as an enteral nutrition connector that is connected to a female connector provided on the upstream side, and a tube used for enteral nutrition other than a catheter may be connected.

The male connector for enteral nutrition disclosed herein is particularly useful in the field of enteral nutrition that complies with ISO 80369-3.

100A Male connector for enteral nutrition 100B Male connector for enteral nutrition 100C Male connector for enteral nutrition 100D Male connector for enteral nutrition 101 Male connector body 101A Male connector body 103 Coupler 105 Cap 105B Cap 105C Cap 105D Cap 106 Cap 111 Male luer part 112 Connection part 113 Annular groove 115 Flange-shaped part 116 Body grip part 117 Grip surface 121 Coupler stopper 122 Stopper side engagement part 125 Extension part 126 Body side engagement part 131 Large diameter part 132 Small diameter part 133 Annular groove 135 Female screw 141 Downstream extension part 142 Upstream extension part 143 Slit 145 Coupler side engagement part 151 Cap body 152 Cap connection part 154 Ring-shaped part 154A Ring-shaped part 155 Cap engagement portion 156 Notch 157 First end portion 158 Second end portion 159 Return stop portion 161 Central protrusion portion 162 Outer edge portion 170 Cap 171 Top surface portion 172 Cylindrical portion 173 Male thread 175 Downstream end surface 200 Catheter 250 Package 300 Female connector 311 Male thread

Claims (16)

A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler that is movable between a first position where the coupler can be screwed with the female connector and a second position that is downstream of the first position and where the male luer part is exposed;
A cap that closes the opening of the male luer part ,
The cap has a cap body that engages with the male luer portion, a cap connection portion having a first end connected to the cap body and a second end connected to the coupler, and a movement limiting portion that can limit movement of the coupler at the second position. The male connector for enteral nutrition according to claim 1, wherein the coupler is capable of restricting movement at least in the second position. 3. The male connector for enteral nutrition according to claim 1 , wherein the movement limiting portion is a cap engaging portion connectable to the tube, and movement of the coupler can be limited by engaging the cap engaging portion with the tube. A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler that is movable between a first position where the coupler can be screwed with the female connector and a second position that is downstream of the first position and where the male luer part is exposed;
A cap that closes the opening of the male luer part ,
The cap has a cap body and a cap connection part having a first end connected to the cap body and a second end assembled to the male connector body or the tube,
a cap connection portion having at least a portion located within an inner cavity of the coupler when the coupler is in the second position, the first end portion located downstream of the coupler, and the second end portion located upstream of the coupler . A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler that is movable between a first position where the coupler can be screwed with the female connector and a second position that is downstream of the first position and where the male luer part is exposed;
A cap that closes the opening of the male luer part ,
The cap is a male connector for enteral nutrition, the male connector comprising: a cap body; a cap connection portion having a first end connected to the cap body and a second end assembled to the male connector body or the tube; and a movement limiting portion that limits the movement of the coupler . A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler that is movable between a first position where the coupler can be screwed with the female connector and a second position that is downstream of the first position and where the male luer part is exposed;
A cap that closes the opening of the male luer part ,
The male connector for enteral nutrition, wherein the cap cannot close the opening of the male luer part when the coupler is in the first position. A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler that is movable between a first position where the coupler can be screwed with the female connector and a second position that is downstream of the first position and where the male luer part is exposed;
A cap that engages with the male luer part ,
The cap has a gripping portion that is gripped to release the engagement with the male luer portion,
When the cap is engaged with the male luer portion and the coupler is in the first position, the gripping portion is received within the coupler;
The male connector for enteral nutrition, wherein the gripping portion is exposed by moving the coupler to the second position. A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side and a tube connected to the downstream side;
a coupler movable between a first position capable of being screwed into the female connector and a second position downstream of the first position where the male luer part is exposed;
The coupler is a male connector for enteral nutrition having a side slit capable of holding the tube. The coupler has a side slit extending from its upstream end to its downstream end.
The male connector for enteral nutrition according to any one of claims 1 to 7 . the coupler having a downstream extension;
10. The male connector for enteral nutrition according to claim 1 , wherein the axial dimension of the coupler including the downstream extension is 75% or more of the axial dimension of the male connector body. the coupler having an upstream extension;
11. The male connector for enteral nutrition according to claim 1, wherein the upstream extension portion extends in the axial direction toward the upstream side so as to cover 70% or more of the axial dimension of the female connector when the coupler and the female connector are screwed together. 12. The male connector for enteral nutrition according to claim 1, further comprising an indicator that indicates to a user to move the coupler to the second position before engaging or disengaging the male connector body and the female connector. The male connector body has a body gripping portion provided downstream of the male luer portion,
The male connector for enteral nutrition according to claim 1 , wherein the main body gripping portion has an axial cross-sectional shape different from that of the male luer portion. The male connector body has a body gripping portion provided downstream of the male luer portion,
13. The male connector for enteral nutrition according to claim 1, wherein the main body gripping part is hidden within the coupler when the coupler is in a first position, and is exposed by moving the coupler to a second position. The male connector for enteral nutrition according to any one of claims 1 to 14 , wherein the male connector for enteral nutrition is contained in a packaging body with the coupler disposed in the second position where the male luer part is exposed. A male connector body having a male luer part on the upstream side that can be inserted into a female connector for enteral nutrition provided on the upstream side, and a connection part on the downstream side that can be connected to a catheter to be inserted into a body cavity;
a coupler movable between a first position where the coupler can be screwed with the female connector and a second position that is closer to the catheter than the first position and where the male luer portion is exposed;
A cap that closes the opening of the male luer part ,
The cap has a cap body that engages with the male luer portion, a cap connection portion having a first end connected to the cap body and a second end connected to the coupler, and a movement limiting portion that can limit movement of the coupler at the second position.

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