JP7539168B2 - Medical Connectors - Google Patents

Description

The present invention relates to a medical connector installed in an infusion line, and more specifically, to a medical connector for connecting a male tapered portion of a syringe or the like to an infusion line.

For example, when mixing different medicinal fluids into an infusion line, there is a connector equipped with a valve made of a rubber elastic material that can be connected to the male tapered portion of an injection device such as a syringe without using an injection needle or stopcock. With this connector, when the male tapered portion is inserted into the valve, an opening such as a slit in the valve is pushed open, securing a fluid passage, and when the tapered portion is removed, the opening of the valve returns to its original closed state, blocking the passage.

Conventional connectors that have been proposed include, for example, a medical connector as disclosed in Patent Document 1, in which a disk-shaped valve member with a slit in the center is placed on a pedestal that protrudes inward from the inner periphery of the housing, and a ring member that is joined to the housing is provided on the peripheral portion of the upper surface of the valve member, with the valve member being sandwiched between the ring member and the housing; and a medical connector as disclosed in Patent Document 2, in which the peripheral portion of a valve member provided within the housing is sandwiched from above and below by the housing, with the slits in the valve member formed radially, thereby reducing frictional resistance between the outer periphery of the male taper portion and the inner surface of the slit, preventing the valve member from falling off the housing and allowing it to be held stably.

The connector forms a passage with the infusion line by pushing open the slit of the valve member with the male taper and penetrating it. However, when the tip of the male taper penetrates the valve member and comes into contact with the inside of the fluid passage, there is a possibility that bacteria or dirt adhering to the taper will contaminate the inside of the passage. Therefore, in order to place a rubber-elastic valve member in the housing, an escape space (space that allows the valve member to escape in the axial direction) and a gap (space that allows the valve member to escape in the circumferential direction) are formed in the housing. When the male taper presses the valve member to connect to the connector, the valve member deforms, opening the slit, and part of the valve member enters the escape space and gap, dispersing the pressure on the pressing surface of the valve member and preventing excessive pressure from being applied to the pressing surface. As a result, the tip of the male taper does not penetrate the valve member, and as a result, the tip hardly comes into contact with the inside of the fluid passage. In the connector of Patent Document 3,

JP 2009-011820 A WO2014/046271 publication JP 2002-035140 A

According to the device of Patent Document 3, when the male taper presses the upper surface of the valve member and crushes the valve member, the valve member extends downward and outward, opening a slit and forming an opening, but the pressing surface of the valve member does not receive a large force and only presses down the valve, and the tip surface of the syringe does not enter the slit and is kept in contact with only the upper surface of the valve member. Therefore, the surface of the male taper hardly comes into contact with the medicinal liquid in the infusion line, and the inside of the fluid passage can be kept hygienic. However, since there is a lot of space around the valve member and the male taper has a large degree of freedom of deformation when attaching and detaching, there is a concern that the valve member will always be deformed into the intended stable shape. In addition, there is a possibility that residual liquid of the medicinal liquid may enter and remain in spaces such as gaps during or after injection of the medicinal liquid, etc., and there is a concern that bacterial contamination may spread within the infusion route when re-injecting, etc.

Meanwhile, in the medical device industry, cases of medical accidents caused by incorrect connection of medical connectors have been reported both in Japan and overseas. This stems from the fact that convenience has been prioritized and the same connector standard (connection by luer taper) has been used for all applications such as infusion. Therefore, measures have been taken to prioritize safety, such as revising standards so that connectors used for enteral nutrition lines and infusion lines cannot be physically connected depending on the application. In recent years, in order to prevent incorrect connection of connectors, international standards have been established in the fields of neuroanesthesia and enteral nutrition, and it has been decided to gradually introduce connectors that prevent misconnection. In particular, in the field of neuroanesthesia, the switch to the new standard (ISO 80369-6) has already been made, and there is an urgent need to provide various connectors that comply with the new standard.

This new standard in the field of neuroanesthesia employs a smaller taper than the old standard's Luer taper, and since it is mandatory to provide a collar around the tapered portion of the male connector, a small-bore structure that is compatible with this standard is also required for the female connector. However, simply making the tapered mating portion of a connector with a conventional structure smaller creates structural and manufacturing problems, such as strength issues, making it difficult to apply as is.

For example, the conventional connectors of Patent Documents 1 and 2 are configured to hold the valve member in the housing by clamping it from above, below, or both sides at the peripheral edge, and if this configuration is adopted for a connector of the new standard, the connection between the valve member and the housing will have to be made smaller as the size is reduced, which raises concerns that the physical strength and manufacturing will become more difficult, and that the strength of the connection will be weakened. The connector of Patent Document 3 also has similar concerns about size reduction, as it requires space such as gaps. In addition, providing a slit as an opening for a small-diameter valve member is concerned as it may cause inconveniences such as insufficient stretching in response to pressure due to a relative reduction in elastic material, making the slit that serves as the opening more susceptible to damage.

The present invention aims to provide a medical connector that is used to connect the male tapered portion of a syringe or the like to an infusion line, and that does not contaminate the fluid passage when the male tapered portion is connected to the connector, and that can be safely and reliably applied to new small-diameter standards.

The medical connector of the present invention is a connector for connecting a male taper portion to an infusion line, and is provided with an opening which opens and closes a passage to the infusion line by inserting and removing the male taper portion, and is composed of a valve member made of an elastic member and a housing made of a hard member with its upper surface and part of its outer peripheral surface fixedly attached to the valve member, and is formed in a manner such that a cap is attached to the housing by the valve member.When the male taper portion is inserted into the connector and a passage to the infusion line is formed, the male taper portion comes into contact only with the upper surface of the valve member and does not enter the opening.

The following parts are preferably formed as follows:
A pinhole mark is provided at the center of the upper surface of the valve member as an opening setting portion that forms a through hole when the male tapered portion is inserted.
The pinhole mark that serves as the opening setting portion is formed by the penetration of a needle tube having a conical tip.
The inner diameter of the opening in the upper surface of the housing is set to 3.6 mm or more and 3.9 mm or less.
The valve member and the housing are integrally formed by two-color molding.

In addition , the upper surface of the valve member consists of a pressed portion formed in the central portion and abutting the tip of the male taper portion when the male taper portion is inserted, and an upper surface edge portion formed around the pressed portion, the pressed portion being formed thicker than the upper surface edge portion, and a gap being provided between the opening in the upper surface of the housing and the peripheral surface of the pressed portion.

(Action)
According to this means, the valve member is formed in a manner that the housing is capped, and since the upper surface and the outer circumferential surface of the housing are fixed, no mechanism for holding the valve member within the housing is required, which makes it easy to form a small-diameter connector. Furthermore, when the male tapered portion is pushed into the valve member to be inserted, the valve member made of an elastic material is stretched almost only in the axial direction of the valve, and deformation of the valve member due to pressure is stable.

In addition, by making the opening setting part that opens when the male taper part is inserted into a pinhole mark, the passage to the infusion line is not opened larger than necessary, and the pinhole mark can be set extremely small relative to the taper tip, so that the male taper tip only presses against the upper surface of the valve member, and the tip does not directly contact the opening setting part. Furthermore, by using a needle tube with a conical tip to form the pinhole mark, the through hole becomes circular, so that when the male taper part is pressed to open the opening, pressure is applied evenly across the entire opening, and no parts that are prone to tearing, such as the ends of a slit, are formed, reducing the risk of damage to the valve member.

By setting the inner diameter of the opening on the top surface of the housing to 3.6 mm or more and 3.9 mm or less, it is possible to connect and hold connectors for the new standard for neuroanesthesia, and also to prevent connection of connectors of the Luer taper standard and the male taper parts of connectors of other standards.

By forming the valve member and the housing as a single unit using two-color molding, the upper surface and part of the outer circumferential surface of the housing can be securely fixed to the corresponding connection part of the valve member, and there is no concern that the connection part will come loose even if the male taper part presses against the valve member. In addition, since no other means such as a clamping part is required to fix the valve member to the housing, the structure is simple and manufacturing is easy. Furthermore, since the connection part of the connector can be formed with a small diameter, it can be used with small-diameter connectors required by the new standard.

When the male taper is inserted into the connector constructed by the above means to form a passage to the infusion line, the tip surface of the male taper, which may become contaminated by foreign matter, is not allowed to come into contact with the passage to the infusion line, so the inside of the infusion line is not made dirty. Also, the only area where residual liquid may remain after the male taper is removed is the flat upper surface of the valve member, which comes into contact with the male taper. This allows for easy removal and sterilization, and cleanliness can be maintained, so that the inside of the infusion line will not be contaminated when the male taper is reconnected.

The present invention provides a medical connector that is used to connect the male taper of a syringe or the like to an infusion line, does not contaminate the inside of the infusion line when the male taper is connected to the connector, can safely and reliably connect the male taper, and is easy to configure and manufacture, and conforms to the small-diameter connector standard required in the new neuroanesthesia field.

1 is a cross-sectional view showing a configuration of a medical connector showing an example of an embodiment of the present invention. FIG. 2 is an overall configuration diagram showing a branch pipe provided midway through an infusion line to which the medical connector of the above-mentioned embodiment is attached. 4A and 4B are partial cross-sectional views showing the front and top surfaces of the branch pipe; 4A and 4B are a partial cross-sectional front view and a top view showing a plug-in type connector to which the medical connector of the above embodiment is attached. 1 is a schematic diagram showing the state in which the male tapered portion is inserted into the branch pipe of the embodiment (before connection); 1 is a schematic diagram showing the state in which the male tapered portion is inserted into the branch pipe of the embodiment (during connection); 1 is a schematic diagram showing the state in which the male tapered portion is inserted into the branch pipe of the embodiment (after connection); A cross-sectional view showing the standard size of the male taper of the international standard (ISO 80369-6 standard) for small-diameter connectors in the neuroanesthesia field.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of a medical connector according to the present invention will be described in detail with reference to the drawings.
The medical connector of this example is a connector used for, for example, co-injection of a medicinal liquid in one shot into an infusion line that continuously injects another medicinal liquid for a long period of time, and is configured as a connector equipped with a branch line in the middle of the main route of the infusion line to connect a male tapered portion of a syringe, etc. Although the medicinal liquid used and the application are not specified, in this example, it is particularly suitable for co-injecting anesthetics, and is formed as a female connector that can insert and remove a male tapered portion that conforms to the international standard ISO80369-6 for small-diameter connectors in the field of neuroanesthesia in terms of size and structure.

Before explaining the embodiment of the present invention, we will briefly explain the size of the male taper specified in ISO 80369-6 that can be connected to the connector of this example. The male taper of this standard includes locking connectors equipped with a locking mechanism (lock ring) that secures the connection with the female taper by screws around the male taper, and slip connectors that have a collar around the male taper that does not have a locking mechanism, but here we will only describe an example of a slip connector as a representative example. Note that the connector of this invention does not exclude locking connectors.

Figure 8 shows a slip-type male connector that meets the international standard ISO80369-6 for connectors in the field of neuroanaesthesia, which is defined as one of the small bore connectors. A connector (male taper) 40 of this standard consists of a male taper portion 41 and a collar 42 provided around the taper portion 41, and the sizes of each portion of the male taper 40 are as follows:
-Taper angle 5/100.
(The following values are in mm, with minimum (nominal) and maximum values listed in that order.)
- Recess or protrusion of connector tip (male tapered portion 41) from collar 42 -4 (0) +4.
Male taper tip outer diameter (a) at a position 0.5 mm (reference dimension) from the male taper tip: 3.17 (3.21) 3.25.
• Male taper tip inside diameter (b) – (1.15) 2.3.
- Male taper large end outer diameter (c) at a position 6.5 mm (reference dimension) from the male taper tip: 3.45 (3.51) 3.57.
-Inner collar diameter (d) 6.75 (6.875) 7.0.
-Connector length from male taper tip (g) 8.0 (8.3) -
• Inside diameter of connector fluid lumen (f) – (1.15) 2.3.
Diameter of the smallest cylinder surrounding the outer surface of the collar outer shape (e) 9.8 (10.5) 11.5.
It is as follows.

In contrast, the sizes of each part of the lure taper standard (ISO 80369-7) are as follows:
-Taper angle 6/100.
- Male taper tip outer diameter at a position 0.75 mm (reference dimension) from the male taper tip: 3.97 (4.021) 4.07.
・Male taper tip inner diameter – (2.1), 2.9.
- Male taper large end outer diameter at a position 7.5 mm (reference dimension) from the male taper tip: 4.376 (4.426) 4.476.
- Male taper length 7.5 (8.4) 10.5.
Compared to a Luer taper, the taper in the new standard for neuroanesthesia (ISO 80369-6) has an outer diameter of the male taper that is thinner than the Luer taper, at approximately 0.8 mm at the tip and approximately 0.9 mm at the large end, and even male tapers that do not have a locking mechanism are provided with a collar that is approximately the same height as the taper (within 0±0.4 mm).

FIG. 1 is a cross-sectional view of a medical connector showing an example of an embodiment of the present invention, FIG. 2 is an overall configuration diagram of a branch pipe connector to which the medical connector is attached, and FIG. 3 shows a partially cross-sectional front view (B) and a top view (A) of the branch pipe connector.
As described above, the medical connector (female connector) 10 of this embodiment is a valved connector that is attached to the side tube side of the branch tube connector 20 installed midway along an infusion line, and is composed of a valve member 11 that opens and closes the passage to the infusion line by inserting and removing the male tapered portion 41 of a drug injection instrument such as a syringe, and a housing 12 to which the valve member 11 is fixed with a cap attached to the tip side.

The valve member 11 is selected from materials with high elasticity and rubber elasticity such as isoprene rubber, silicone rubber, natural rubber, and thermoplastic elastomers (in this example, styrene-based elastomers), and is formed into a cylindrical cap shape by the upper surface of the valve member 11, which is formed almost flat, and the valve peripheral surface 112, which is the side surface. The central part of the upper surface is formed thicker than the upper surface edge as the pressed part 111, which is the contact part with the tapered part, and a pinhole mark 13 is provided in the center of the pressed part, which forms a through hole when the male tapered part 40 is inserted. The peripheral part, which is formed thinner than the pressed part 111, is formed into a circular groove shape, which fits with the tip side of the housing 20 described later, and becomes a fixed part with the housing upper surface 123. On the other hand, the valve peripheral surface 112 is formed into a cylindrical shape with approximately the same thickness as the groove part of the upper surface edge, and its inner surface becomes a fixed part with the housing 12.

The pinhole mark 13, which serves as the opening setting portion at the center of the pressed portion 111, is a cylindrical through hole mark that is closed by the elasticity of the valve member 11 in its natural state, maintaining the airtightness of the infusion line. When the male taper portion 41 is pressed and inserted into the pressed portion 111, the valve member 11 stretches and deforms, opening the pinhole mark 13 and providing a passage to the infusion line. The pinhole mark 13 is formed in the valve member 11 by penetrating a needle tube with a conical tip into the center of the pressed portion 111. In this example, a needle tube with a conical point and a diameter of 0.76 mm was used.

The housing 12 is formed into a cylindrical shape with multiple steps from a hard resin capable of retaining its shape, for example, a thermoplastic resin such as polypropylene, polyethylene, polycarbonate, polystyrene, polyacetal, etc. (in this example, polypropylene). The tip side tube portion 121 of the housing 12 is the small diameter side on which the valve member 11 is attached, and the valve crown attachment portion 122 is formed thin by the thickness of the valve circumferential surface 112 of the valve member 11, and is formed so that when the valve member 11 is attached, it becomes a cylinder of the same outer diameter without steps. In addition, the edge portion of the tip protrudes slightly inward to form the housing upper surface 123. The tip side tubular portion 121 may be formed to a size that matches the shape of the male taper to be inserted, but in this example, the inner diameter of the tip portion of the housing 12 is formed to match the standard of the small-diameter male taper 41 in a range of 3.6 mm or more, which allows the Maximum dimension of the outer diameter of the male taper portion 41 of the standard, 3.570 mm, to pass through, and 3.9 mm or less, which does not allow the Min dimension of the male luer taper standard, 3.97 mm, to be inserted. (Specific tip inner diameter in this example: 3.6 mm, inner diameter other than the tip: 4.0 mm) Also, the outer diameter of the tip side tubular portion 121 of the housing 12 (the outer diameter of the valve crown portion 122 when the valve member 11 is crowned) is formed to be smaller than 6.75 mm, which is the Min value of the inner diameter of the collar 42 of the standard of the small-diameter male taper 41, so that it fits within the collar 42 of the standard of the small-diameter male taper 41. (Specific outer diameter in this example is 6.2 mm) Furthermore, the depth of the inner cavity space 14 of the thin-diameter inner cylinder is set to be greater than the maximum insertion length of the taper of the small-diameter male taper standard, which is about 6.5 mm. (Specific depth in this example is 7.5 mm)

On the other hand, the base side tube portion 124 of the housing 12 is the large diameter side that fits into the side pipe wall 25 of the branch pipe connector 20 described below, and the edge of the end protrudes slightly inward to form the housing underside. The base side tube portion 124 may be formed to a size that matches the shape of the side pipe to be fitted, but in this example, it has an inner diameter of 9.1 mm, an outer diameter of 10.5 mm, and a bore depth of 5.4 mm to fit the branch pipe connector described below. By providing a step between the tip side tube portion 121 and the base side tube portion 124, when the male taper portion 41 is inserted, if it is inserted too deeply, the shoulder portion 125 of the step will come into contact with the collar 42 of the taper portion, preventing excessive insertion of the taper portion.

The valve member 11 is attached to the housing 12, but there is a small gap 15 around the top surface 123, which is the tip of the housing 12, and the thickly pressed portion 111 of the valve member 11, which provides an escape space that can expand slightly toward the circumferential side due to the pressure from the male taper portion 40. The valve member 11 and the housing 12 can also be attached to each other by adhesion, but by forming the styrene elastomer that forms the valve member 11 and the polypropylene that forms the housing 12 into one piece by two-color molding, the back surface of the upper edge of the valve member 11 and the upper surface 123 of the housing, and the inner surface of the valve member circumferential surface 112 and the valve crowning surface 122 of the housing are fixed in place so that they will not shift or break even when pressed by the male taper 40.

The female connector 10 formed as described above is fitted into the side pipe wall 25 that forms the side pipe route 27 of the branch pipe connector 20. The branch pipe connector 20 of this example is also formed in accordance with the standard (ISO80369-6) for small-diameter connectors in the field of neuroanesthesia described above, and is composed of a branch pipe body 21 including a main pipe route 26 and a branch pipe route 27, a male taper section 22 of small diameter standard provided on one side of the main pipe route, a female taper section 24 of small diameter standard provided on the other side, and a side pipe wall 25 that becomes a side pipe that forms a side pipe route branched off at the branch pipe body 21, and a lock ring 23 that fixes the corresponding female taper section is attached to the male taper section 22.

The male taper section 22 and the female taper section 24 are connected to a tube or the like having a connector with a corresponding female taper and male taper, respectively, and fixed in place by a lock ring 23, and the female connector 10 of the present invention is connected to the side tube wall 25 by adhesive or the like.

FIG. 4 shows a front view (B) and a top view (A) of a plug-in type connector to which the medical connector 10 of the present invention is connected.
The connector of this example is a plug-in connector 30 that can be used as an injection port by connecting to a corresponding female taper including the branch, rather than being connected only to the branch of an infusion line as described above, and is formed in accordance with the standard (ISO80369-6) for small-diameter connectors in the field of neuroanesthesia, similar to the branch pipe connector 20. The plug-in connector 30 is composed of a male taper section 31 with a lock 32 conforming to the standard, and a connection section 33 for the female connector 10 of the present invention provided at the base of the male taper section 31, and similar to the branch pipe connector 20, the female connector 10 of the present invention is connected to the connection section 33 with an adhesive or the like.

Figures 5 to 7 are schematic diagrams showing how a male taper section that complies with the small-diameter connector standard (ISO 80369-6) for the neuroanesthesia field is inserted into the medical connector of the present invention. Figure 5 shows the state before insertion, Figure 6 shows the state during insertion, and Figure 7 shows the inserted state.

Before connecting the male taper portion 41 of the syringe 50 to the female connector 10, the needle hole 13 that serves as the opening setting portion in the valve member 11 is in a closed state, ensuring that the infusion line is kept airtight.

When the tip of the male taper portion 41 is pressed into the pressed portion 111 of the valve member 11 of the female connector 10, the valve member 11 stretches due to its elasticity and is pressed down into the inner cavity space 14 of the housing 12, gradually widening and opening the needle mark 13 provided in the center of the pressed portion 11.

When the male tapered portion 41 is further pushed into the female connector 10 until the tapered collar 42 comes into contact with the shoulder 125 of the housing 12 and is completely inserted, the pressed portion 111 of the valve member 11 extends further and is pressed into the internal space 14 of the housing 12, the pinhole mark 13 is pulled around and opens, and a passage to the infusion line is formed as the opening 131. At that time, because the tip opening of the male tapered portion 41 is formed larger than the opened pinhole mark 13 opening 131, the tip surface of the taper only presses the upper surface of the pressed portion 111 of the valve member 11 and does not come into contact with the infusion line.

The medical connector of this embodiment employs a structure in which the valve member 11 is attached to the housing 12 in a cap-like manner, and therefore does not require a clamping section or the like on the housing as a structure for attaching the valve member to the housing, allowing the insertion section with the male taper section to be formed small and thin in diameter. In addition, by using two-color molding to connect the valve member 11 and the housing 12, the parts can be securely fixed together even with the above-mentioned capping structure. This allows safe and reliable application to the male taper section of the connector standard for neuroanesthesia (ISO 80369-6), which is a smaller taper standard than conventional standards.

In addition, the opening 131 that opens when the female taper portion 41 is inserted into the valve member 11 is formed in a circular shape with a smaller diameter than the opening of the male taper portion 41, so that the force applied to the periphery of the pinhole mark 13 at the opening 131 is uniform, and since there is no part with weak strength such as the end of the slit, the risk of the valve member 11 being damaged even with a large pressure during insertion is small. In addition, the surface part, including the tip surface of the male taper portion 41, which may become dirty, does not physically come into contact with the housing inner cavity space 14, which is part of the drug solution line, or the surface of the opening 131 of the valve member 11, so that the drug solution line is not contaminated. In addition, the part where residual liquid that may cause contamination after drug solution injection is likely to adhere is limited to the upper surface of the valve member 11, which is formed almost flat, making it easy to remove residual liquid and sterilize, and the risk of infection can be reduced even when used multiple times as an injection port.

10. Medical connector 11. Valve member 111. Pressurized portion 112. Valve circumferential surface 12. Housing 121. Tip side tubular portion 122. Valve crown attachment portion 123. Housing upper surface 124. Base side tubular portion 125. Shoulder portion 13. Pinhole mark 14. Lumen space 15. Gap 20. Branch pipe connector 21. Branch pipe body 22. (Branch pipe) Male tapered portion 23. Lock ring 24. (Branch pipe) Female tapered portion 25. Side pipe wall 26. Main pipe route 27. Side pipe route 30. Plug-in connector 31. (Plug) Male tapered portion 32. Lock 33. Connection portion 40. Standard female connector (ISO 80369-6)
41. Male taper part 42. Collar 5. Syringe

Claims (6)

A connector for connecting a male tapered portion to an infusion line,
a valve member made of an elastic material and having an opening for opening and closing a passage to an infusion line by inserting and removing the male tapered portion;
a housing made of a hard member, the upper surface and a part of the outer circumferential surface of which are fixedly attached to the valve member;
The valve member is formed in a manner of capping the housing,
A medical connector characterized in that when a male tapered portion is inserted into the connector and a passage to an infusion line is formed, the male tapered portion only contacts the upper surface of the valve member and does not enter the opening .
The medical connector of claim 1, which has a pinhole mark at the center of the upper surface of the valve member as an opening setting part that forms a through hole by inserting the male tapered part. The medical connector of claim 2, wherein the pinhole mark provided as the opening setting portion is formed by the penetration of a needle tube having a conical tip. the upper surface of the valve member is formed with a pressed portion formed in a central portion thereof and abutting against the tip of the male tapered portion when the male tapered portion is inserted, and an upper surface edge portion formed around the pressed portion;
The pressed portion is formed thicker than the upper surface edge portion,
4. The medical connector according to claim 1 , wherein a gap is provided between an opening on the upper surface of the housing and a peripheral surface of the pressed portion . 5. The medical connector according to claim 1 , wherein the inner diameter of the opening in the upper surface of the housing is 3.6 mm or more and 3.9 mm or less. 6. The medical connector according to claim 1, wherein the valve member and the housing are integrally formed by two-color molding.

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