WO2015037271A1

WO2015037271A1 - Cap-equipped connector for medical use

Info

Publication number: WO2015037271A1
Application number: PCT/JP2014/062265
Authority: WO
Inventors: 克教河合; 加藤　亮; 五十右　勝美
Original assignee: 日機装株式会社
Priority date: 2013-09-12
Filing date: 2014-05-07
Publication date: 2015-03-19
Also published as: JP6151614B2; JP2015054137A

Abstract

　This cap-equipped connector (10) is provided with a female connector (12) for attachment an open end of a medical fluid line, and a cap (20) for covering the opening of the female connector (12). The cap (20) has a boss part (26), between which part and the inside surface of the female connector (12) a gap is formed at a first position of advance, the boss part (26) being advanced by a first operation from the outside of the female connector (12) to the first position of advance situated inside the female connector (12), and being advanced by a second operation from the first position of advance to a second position of advance situated inside the female connector (12).

Description

Connector with medical cap

The present invention relates to a connector with a medical cap that includes a female connector attached to an open end of a medical fluid line and a cap that covers the opening of the female connector.

A medical fluid circuit such as an extracorporeal circulation circuit for blood purification is provided with a fluid line through which a medical fluid (for example, blood or the like) flows. Since other fluid lines may be connected to such a fluid line, a connector that can be connected to the open ends of other fluid lines is usually provided at the open ends of the fluid lines. When the connector is a cylindrical female connector into which an open end of another medical fluid line is inserted, a cap may be attached to the female connector to prevent contamination.

Patent Document 1 discloses a cap attached to such a female connector. The cap in Patent Document 1 has a cylindrical main body and a mounting portion protruding inside the main body, and the mounting portion has an outer shape in order from the base end side (the side far from the female connector). A certain flat part and a taper part which tapers toward the front end side (side near the female connector) are arranged in the flat part through the step part. Further, a female screw that can be screwed with a male screw formed on the outer peripheral surface of the female connector is formed on the inner peripheral surface of the cap body. According to such a cap, even when the female connector has a luer taper, the inner surface of the female connector and the outer surface (flat portion) of the mounting portion are brought into close contact with each other by inserting the cap mounting portion to the back side of the female connector. It is possible to improve air tightness and liquid tightness.

Japanese Patent No. 4276134 JP 2012-16472 A

By the way, such a connector with a medical cap is subjected to heat treatment for sterilization with the cap attached to the female connector. During this heat treatment, the shape of the female connector may change depending on the material of the female connector. As a material of the female connector, for example, a soft material such as polyvinyl chloride (PVC) may be used. However, such a material is excellent in chemical resistance, but has a property of being easily heat-shrinkable.

However, when heat treatment is performed on a female connector made of a soft material with a cap as described in Patent Document 1, the inner surface of the female connector is attached to the mounting portion in the process of thermal contraction. Will be deformed into a shape along the outer surface of the mounting portion. The female connector thus deformed may have insufficient airtightness or liquid tightness when connected to another fluid line.

In order to avoid such a problem, heat treatment should be performed in a state in which only a part of the mounting portion enters the female connector without inserting the cap mounting portion to the back of the female connector. However, in the cap of Patent Document 1, a female screw for attaching the cap to the female connector is formed continuously from the distal end to the proximal end of the cap body. Therefore, in the cap of Patent Document 1, it is difficult to pay attention to the insertion amount of the mounting portion when the cap is attached to the female connector, and the mounting portion may be inserted to the back side of the female connector. Patent Document 2 also discloses a cap that is attached to the female connector, but this cap is not considered to restrict the amount of insertion of the cap into the female connector.

Therefore, an object of the present invention is to provide a connector with a medical cap that has improved air tightness and liquid tightness when connected to other fluid lines.

The connector with a cap of the present invention is a connector with a medical cap comprising a female connector attached to an open end of a medical fluid line, and a cap that covers the opening of the female connector. An entry portion that enters from the outside of the female connector to the first entry position inside the female connector by the operation of, and enters from the first entry position inside the female connector to the second entry position by the second operation, The first entry position includes an entry portion that forms a gap with the inner surface of the female connector.

In a preferred aspect, the cap is configured such that when the boss projecting from the cap reaches the first entry position, the cap is brought into contact with a part of the female connector, whereby the boss is formed by a first operation. A first restricting part that restricts further entry of the vehicle. In another preferred aspect, the first operation is the axial direction of the cap with respect to the female connector (in this specification, “axis” refers to a center line of rotational movement when the outer cylinder rotates, "Axial direction" refers to an operation of moving the center line in the length direction), and the second operation rotates the cap around the axis relative to the female connector at the first entry position. Including the operation to be performed. In still another preferred aspect, the entry portion has an outer shape that decreases in diameter as it approaches the tip, and the female connector has an inner shape that decreases in diameter as it advances toward the back side. In still another preferred aspect, the cap has a disconnection preventing portion that restricts complete detachment of the boss portion from the inside of the female connector by contacting a part of the female connector.

Another connector with a cap according to the present invention is a connector with a medical cap provided with a female connector attached to an open end of a medical fluid line, and a cap covering the opening of the female connector, An outer cylinder that covers the outer periphery of the female connector; a top that covers one end of the outer cylinder; and a boss that protrudes in the axial direction in the outer cylinder and enters the female connector; A boss having a gap with the inner surface of the female connector when entering the first entry position, and a portion of the female connector abutting when the boss enters the first entry position. A first restricting portion for restricting further entry of the boss portion, and a female screw formed on the inner surface of the outer cylinder and screwed with a male screw formed on the outer peripheral surface of the female connector, When the part reaches the first entry position, it starts to be screwed with the female screw formed on the outer peripheral surface of the female connector, and the cap is rotated so that the boss part is located behind the first entry position. And a female screw guided to the side.

According to the present invention, the operation type when entering the first entry position is different from the operation type when entering from the first entry position to the second entry position. The amount of connection to the female connector can be clearly recognized, and when using a connector with a cap, it has the effect of improving air tightness and liquid tightness when connected to other fluid lines. .

It is sectional drawing before the assembly | attachment of the connector with a cap which is embodiment of this invention. It is sectional drawing after the assembly | attachment of the connector with a cap. It is sectional drawing in the usable state of a connector with a cap. It is a perspective view of a cap. It is a figure which shows the structure of a venous side blood circuit.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. 1 to 3 are cross-sectional views of a connector 10 with a medical cap according to an embodiment of the present invention. Among these, FIG. 1 is a sectional view before assembling the cap, FIG. 2 is a sectional view after assembling the cap (first entry position), and FIG. 3 is a sectional view in a usable state (second entry position). FIG. 4 is a perspective view of the cap 20. Furthermore, FIG. 5 is a block diagram of the blood circuit 50 to which the connector with cap 10 is attached.

The connector 10 with a cap is a female connector used in a medical fluid circuit such as an extracorporeal circulation circuit for blood purification connected to a dialysis apparatus for performing dialysis treatment. Below, the female connector used for the venous blood circuit among the extracorporeal circulation circuits for blood purification will be described as an example.

As is well known, an extracorporeal circuit for blood purification is a dialyzer that purifies blood flowing through a blood circuit interposed between the arterial blood circuit and the venous blood circuit, and the arterial blood circuit and the venous blood circuit. It is configured. A shunt connector to which a puncture needle is connected is disposed at the distal end of the arterial blood circuit, and an iron-type blood pump and an air trap chamber for defoaming are respectively disposed in the middle. Connected to the inlet.

FIG. 5 is a diagram showing a venous blood circuit 50 which is an example of a medical fluid circuit. A shunt connector 51 to which a puncture needle is connected is provided at the distal end of the venous blood circuit 50, an air trap chamber 54 for removing bubbles is provided in the middle, and a blood outlet port of the dialyzer is provided at the proximal end. A dialyzer lock connector 52 for connection is provided. Further, a monitor line 56 is connected to the air trap chamber 54, and a connector 58 for connection with a venous pressure sensor is connected to the tip of the monitor line 56. Further, the connector 10 with a cap is connected to the air trap chamber 54 via the female connector body 60. When the chemical solution is introduced into the blood flowing through the venous blood circuit 50, another fluid line such as a syringe is connected to the female connector of the connector 10 with cap, and the chemical solution is introduced. The female connector can be closed with a cap to prevent contamination.

Next, the configuration of the connector with cap 10 will be described in detail. The cap-attached connector 10 is roughly divided into a female connector 12 that can be connected to other fluid lines and a cap 20 that can close the female connector 12. The female connector 12 is made of a material having excellent chemical resistance, such as polyvinyl chloride (PVC). The female connector 12 has a substantially cylindrical shape, and its inner diameter is reduced as it advances toward the back side (depth direction). Therefore, the inner surface of the female connector 12 is a tapered surface. A male screw 16 is formed on the outer periphery of the female connector 12 so as to be screwed into the cap 20.

The cap 20 is made of a hard material having excellent heat resistance, and examples thereof include polypropylene (PP) and polycarbonate (PC). The cap 20 has a substantially cylindrical shape enough to cover the female connector 12. The cap 20 covers the outer periphery of the female connector 12, the top 24 covers one end of the outer tube 22, and the shaft within the outer tube 22. It is roughly divided into a boss portion 26 protruding in the direction. The cap 20 is provided with a connection ring 28 that is inserted through the female connector body 60 and a connection plate 30 that connects the connection ring 28 and the main body of the cap 20.

The cap 20 is attached to the female connector body 60 by inserting the female connector body 60 through the connection ring 28, and the female connector 12 is disposed at the open end of the female connector body 60. Thereafter, the cap 20 is connected to the female connector 12 so as to cover the opening of the female connector 12. The cap 20 and the female connector 12 connected to each other are subjected to heat treatment for sterilization in order to be used as the venous blood circuit 50. Hereinafter, the state before the cap 20 and the female connector 12 are attached to the female connector body 60 while the cap 20 is connected to the female connector 12 (that is, the state shown in FIG. 1) is referred to as “before assembly”. Further, the state in which the cap 20 is connected to the female connector 12 for sterilization (ie, the state shown in FIG. 2) is referred to as “after assembly”, and the venous blood circuit 50 is ready for use (ie, FIG. 3). Is referred to as “usable state”.

Here, in the connector with cap in the prior art, the connection state of the cap and the female connector was the same before and after the heat treatment, that is, after assembly and in the usable state. In other words, the connector in the prior art allows the cap to be screwed into the female connector until the top of the cap hits the front end surface of the female connector, so that the boss portion has entered the inner wall of the female connector. In some cases, heat treatment for sterilization was performed.

However, if heat treatment is performed with the boss part inserted into the inner wall of the female connector (depth direction), the inner surface of the female connector will eventually deform into a shape along the boss part. End up. In this case, the female connector obtained after the heat treatment has problems such as failure to ensure liquid tightness and air tightness with a male connector attached to another fluid line.

On the other hand, in the embodiment according to the present invention, the connection amount of the cap 20 at the time of assembly can be clearly recognized, and as a result, the female connector 12 can be prevented from being unintentionally deformed. This will be described below.

As described above, the cap 20 of this embodiment is roughly divided into the outer cylinder 22, the top 24, and the boss 26. An insertion port convex portion 32 that protrudes inward and extends around the entire circumference is provided at the tip of the outer cylinder 22. The insertion port convex portion 32 functions as a removal preventing portion that prevents the cap 20 from being removed (completely detached) from the female connector 12, and the inner diameter thereof is the maximum diameter of the female connector 12 (that is, the male screw 16). The outer diameter is slightly smaller. Further, in the inner surface of the outer cylinder 22, a female screw 36 that engages with the male screw 16 formed in the female connector 12 is located in the range from the tip side (side near the female connector 12) to the intermediate height. Is formed. That is, the inner surface of the outer cylinder 22 is roughly divided into a female screw forming portion 37 in which the female screw 36 is formed and a smooth portion 38 in which the female screw 36 and the like are not formed. At the boundary between the female screw forming portion 37 and the smooth portion 38, a central convex portion 34 that protrudes inward and extends all around is provided. The central convex portion 34 functions as a first restricting portion that restricts the amount of entry of the boss portion 26, and has an inner diameter that is slightly smaller than the maximum diameter of the female connector 12. Further, the inner diameter of the smooth portion 38 is slightly larger than the maximum diameter of the female connector 12.

The boss part 26 is a part that functions as an entry part that enters the inner surface of the female connector 12. The boss portion 26 has a stepped truncated cone shape that decreases in diameter as it approaches the tip and changes in a step shape in the middle. The step of the boss portion 26 is formed at substantially the same height as the central convex portion 34 of the outer cylinder 22, and the boss portion 26 is located on the tip side (side closer to the female connector 12) with the step as a boundary. The small-diameter portion 26a and the large-diameter portion 26b located on the base end side (the side far from the female connector 12). The step portion functions as a first restricting portion that restricts the entry of the boss portion 26, and the outer diameter of the boss portion 26 in the step portion is formed to be slightly smaller than the inner diameter of the tip of the female connector 12.

When the stepped portion of the boss portion 26 is made to enter the inner surface of the female connector 12 until it contacts the tip portion of the female connector 12 (state of FIG. 2), the outer peripheral surface of the small diameter portion 26a and the inner surface of the female connector 12 The value is set such that a sufficient gap is formed between the two. Here, the sufficient gap is not less than the amount of change in the inner diameter of the female connector 12 due to thermal contraction. The outer diameter of the large-diameter portion 26b is such that when the boss portion 26 enters the inner surface of the female connector 12 to the farthest side (base end side) (state of FIG. 3), The value is set such that the inner surfaces of the female connector 12 are in close contact with each other while being elastically deformed.

The flow when assembling the cap 20 configured as described above to the female connector 12 will be briefly described. When the cap 20 is assembled to the female connector 12, the outer diameter of the cap 20 is larger than the inner diameter of the insertion port convex portion 32, so that the female connector 12 does not enter the outer cylinder 22. In this state, when an axial force is applied to the cap 20, the male screw 16 is elastically deformed, the male screw 16 gets over the insertion port convex portion 32, and the female connector 12 enters the outer cylinder 22. The female connector 12 that has entered the outer tube 22 is positioned in a smooth portion 38 where the female screw 36 is not formed. The smooth portion 38 is larger than the maximum diameter of the male screw 16 of the female connector 12. Therefore, the female connector 12 can move freely in the axial direction without any particular force. Further, when the female connector 12 enters the outer cylinder 22, the boss portion 26 enters the inner surface of the female connector 12. On the other hand, the female connector 12 that has once entered the outer cylinder 22 is prevented from being detached from the outer cylinder 22 by the insertion port convex portion 32.

When an axial force is further applied to the cap 20 in this state, the outer peripheral edge 40 of the female connector 12 is on the central convex portion 34 and the inner peripheral edge 41 of the female connector 12 is on the step surface of the boss 26. Abut. Due to this contact relationship, further entry of the female connector 12 and further entry of the boss portion 26 are temporarily prevented. As a result, the boss portion 26 is in a state after assembling (state of FIG. 2) that remains at a position where a gap is formed between the boss portion 26 and the inner surface of the female connector 12. The entry position of the boss portion 26 at the time of assembly with respect to the inner wall surface of the female connector 12 is hereinafter referred to as a “first entry position”.

When the assembly of the cap 20 is completed, the cap 20 and the female connector 12 are subjected to heat treatment for sterilization in that state. Although the female connector 12 made of PVC is thermally contracted by the heat treatment, the amount of connection of the cap 20 to the female connector 12 can be clearly recognized, so that the cap 20 and the female connector 12 are independent of the shape of the boss portion 26. It is possible to improve the airtightness or liquid tightness at the time of connection.

A user (for example, a medical worker) rotates the cap 20 around the axis with respect to the female connector 12, and the male screw 16 of the female connector 12 and the female screw 36 of the outer cylinder 22 are screwed (screwed). To proceed. In response to the screwing force at this time, the steps of the female connector 12, the central convex portion 34, and the boss portion 26 are elastically deformed, and the female connector 12 gets over the central convex portion 34 and the boss portion 26 to Proceeding to the back side (the base end side of the cap 20), the boss portion 26 also enters the back side of the inner surface of the female connector 12 from the first entry position. If the screwing (screwing) is further advanced, the female connector 12 is finally advanced to a position where the outer peripheral edge 40 and the inner peripheral edge 41 of the female connector 12 come into contact with the top 24. The state becomes possible (the state shown in FIG. 3). The entry position of the boss portion 26 in the usable state with respect to the inner surface of the female connector 12 is hereinafter referred to as a “second entry position”.

As is apparent from the above description, in the present embodiment, when the cap 20 is assembled to the female connector 12, the cap 20 is pushed into the female connector 12 in the axial direction so that the cap 20 can be used. At this time, an operation of rotating the cap 20 in the axial direction with respect to the female connector 12 is performed. In other words, in the present embodiment, the operation type performed for causing the boss portion 26 to enter the first entry position is different from the operation type performed for causing the boss portion 26 to enter the second entry position. Therefore, the assembler can clearly connect the cap 20 to the female connector 12 with a clear awareness of the amount of the cap 20 entering the female connector 12, and accidentally completely connects the cap 20 to the female connector 12 before heat treatment. Can be effectively prevented. As a result, unintended shape deformation of the female connector 12 can be prevented.

In the present embodiment, the central projection 34 is provided on the outer cylinder 22 in order to prevent the cap 20 from coming off. However, the cap 20 is configured such that a part of the cap 20 abuts a part of the female connector 12. If the disconnection is prevented, the central convex portion 34 may be provided on another portion, for example, the outer peripheral surface of the female connector 12 or the like. Similarly, the position and shape of the convex portion for temporarily stopping the boss portion 26 at the first entry position may be changed as appropriate.

Furthermore, in the present embodiment, the boss portion 26 and the inner surface of the female connector 12 are brought into close contact with each other at the second approach position, but liquid tightness and air tightness are not required as a function of the connector 10 with a cap. The boss portion 26 and the inner surface of the female connector need not be in close contact at the second entry position. In the above description, the cap-equipped connector 10 used in the extracorporeal circulation circuit for blood purification has been described as an example. However, the technique of the present embodiment is a medical-cap-equipped connector 10 that requires heat treatment in advance. If so, it may be applied to another connector 10 with a cap.

10 connector with cap, 12 female connector, 16 male thread, 20 cap, 22 outer cylinder, 24 top, 26 boss, 28 connection ring, 30 connection plate, 32 insertion slot convex part, 34 central convex part, 36 female thread , 40 tip outer peripheral edge, 41 tip inner peripheral edge, 50 vein side blood circuit, 51 shunt connector, 52 dialyzer lock connector, 54 air trap chamber, 56 monitor line, 58 connection connector, 60 female connector body.

Claims

A female connector attached to the open end of the medical fluid line;
A cap covering the opening of the female connector;
A connector with a medical cap comprising:
The cap enters from the outside of the female connector to the first entry position inside the female connector by a first operation, and enters from the first entry position to the second entry position inside the female connector by a second operation. An entry portion that has an entry portion that forms a gap with the inner surface of the female connector at the first entry position;
A connector with a medical cap.
The connector with a medical cap according to claim 1,
The cap is
When the boss projecting from the cap reaches the first entry position, the first boss regulates further entry of the boss by a first operation by contacting a part of the female connector. Having a regulation part,
A connector with a medical cap.
A connector with a medical cap according to claim 2,
The first operation is an operation of moving the cap in the axial direction with respect to the female connector;
The second operation includes an operation of rotating the cap around the axis with respect to the female connector at the first entry position.
A connector with a medical cap.
The connector with a medical cap according to claim 1,
The entry portion has an outer shape that decreases in diameter as it approaches the tip,
The female connector has an inner shape that decreases in diameter as it advances to the back side.
A connector with a medical cap.
The connector with a medical cap according to claim 1,
The cap has a disconnection preventing part that regulates complete detachment of the boss part from the inside of the female connector by contacting a part of the female connector
A connector with a medical cap.
A female connector attached to the open end of the medical fluid line;
A cap covering the opening of the female connector;
A connector with a medical cap comprising:
The cap is
An outer cylinder covering the outer periphery of the female connector;
A top that covers one end of the outer cylinder,
A boss that protrudes in the axial direction in the outer cylinder and enters the female connector, and has a gap with the inner surface of the female connector when entering the first entry position inside the female connector. And
When the boss part enters the first entry position, a first restriction part that restricts further entry of the boss part by contacting a part of the female connector;
A female screw formed on the inner surface of the outer cylinder and screwed with a male screw formed on the outer peripheral surface of the female connector, and when the boss part reaches the first entry position, A female screw that starts screwing with a female screw formed on the outer peripheral surface and guides the boss portion from the first entry position to the back by rotating the cap around an axis; and
The connector with a medical cap characterized by having.