JP2023118184A - medical connector - Google Patents

Abstract

To provide a medical connector that conforms to a new standard of a small diameter medical connector and can be used safely and reliably without contaminating a fluid passage by the connection of a male tapered part, the connector being used by connecting the male tapered part to an infusion line.SOLUTION: A medical connector 10 includes a valve member 11 formed of an elastic member for opening and closing a passage to an infusion line by insertion and withdrawal of a male tapered part 41, and a housing 12 formed of a hard member whose top face 123 and part of the outer peripheral surface are fixed to the valve member 11. The valve member 11 is formed in a form that a cap is crowned on the housing 12. A needle hole scar 13 through which a needle tube is penetrated as an opening setting part for forming a through-hole by the insertion of the male tapered part 41 is provided in the center of a pressed part 111 of the valve member. When the male tapered part 41 is inserted into the connector, and the passage to the infusion line is formed, the outer peripheral surface of the male tapered part 41 does not come into contact with the infusion line.SELECTED DRAWING: Figure 1

Description

TECHNICAL FIELD The present invention relates to a medical connector provided on an infusion line, and more particularly to a medical connector for connecting a male tapered portion of a syringe or the like to the infusion line.

For example, there is a connector provided with a valve made of a rubber elastic member that is used by connecting a male tapered portion of an injection device such as a syringe without using an injection needle or a stopcock when injecting another drug solution into an infusion line. With this connector, when the male tapered part is inserted into the valve, the opening such as a slit provided in the valve is expanded to secure a fluid passage, and when the tapered part is removed, the valve opening returns to its original closed state and the passage is closed. is blocked.

Conventionally, such a connector includes a disk-shaped valve member having a slit in the center as disclosed in Patent Document 1, which is placed on a base provided on the inner peripheral surface of the housing so as to protrude inward. A medical connector in which a ring member joined to the housing is provided on the peripheral edge of the upper surface of the valve member, and the periphery of the valve member is sandwiched between the ring member and the housing, or the peripheral edge of the valve member provided in the housing as described above By forming the slits provided in the valve member radially, the frictional resistance between the outer peripheral surface of the male tapered portion and the inner surface of the slit is reduced, and the valve member from the housing is reduced. There have been proposed medical connectors, such as those disclosed in Patent Document 2, which are capable of preventing the falling off of the connector and stably holding the connector.

The connector pushes open the slit of the valve member by means of the male tapered portion or the like to form a passage with the infusion line by penetrating the connector. If they come into contact, the inside of the passage may be contaminated with bacteria or dust adhering to the tapered portion. A space for allowing the valve member to escape in the axial direction) and a gap (a space for allowing the valve member to escape in the peripheral direction) are formed, and when the male tapered portion presses the valve member and is connected to the connector, the valve member deforms, As the slit part opens, a portion of the valve member enters the escape space and the gap, so that the pressing force on the pressing surface of the valve member is dispersed, and excessive force is not applied to the pressing surface. There is a connector in U.S. Pat. No. 5,300,000 wherein the tip does not penetrate the valve member and, as a result, the tip does not substantially contact the interior of the fluid passageway.

JP 2009-011820 A WO2014/046271 Japanese Patent Application Laid-Open No. 2002-035140

According to the instrument of Patent Document 3, when the male tapered portion pushes the upper surface of the valve member and crushes the valve member, the valve member extends downward and outward, the slit opens, and the opening is formed. A large force is not applied to the pressing surface of the member, and the valve is only pushed down, and the tip end 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 tapered portion hardly contacts the liquid medicine in the infusion line, and the inside of the fluid passage can be kept sanitary. However, since there is a large amount of space around the valve member and the degree of freedom of deformation for attachment and detachment of the male tapered portion is large, there is concern that the valve member will always be deformed into the intended and stable shape. In addition, during or after the injection of the drug solution, there is a possibility that the residual liquid of the drug solution may enter the space such as the gap and remain, and when the injection is performed again, contamination such as bacteria may spread in the infusion route. is concerned.

On the other hand, in the medical equipment industry, cases of medical accidents due to misconnection of medical connectors have been reported both in Japan and overseas. This is because convenience has been prioritized and the same connector standard (connection by luer taper) has been used for all applications such as infusions. Measures are being taken to prioritize safety, such as revising standards so that connectors used in lines cannot be physically connected. In recent years, in order to prevent erroneous connection of this connector, international standards have been established in the field of neuraxial anesthesia, enteral nutrition, etc., and it has been decided to gradually introduce erroneous connection prevention connectors. In particular, the field of neuraxial anesthesia has already switched to the new standard (ISO80369-6), and there is an urgent need to provide various connectors that comply with the new standard.

This new standard in the field of neuroanesthesia uses a taper with a smaller diameter than the luer taper of the old standard, and it is an essential requirement to provide a collar around the taper part of the male connector. Therefore, there is a demand for a small-diameter structure that conforms to this standard for the female connector. There are problems in manufacturing, and it is difficult to apply as it is.

For example, in the conventional connectors of Patent Documents 1 and 2, the valve member is held by the housing in such a manner that it is sandwiched from above and below or from both sides by the peripheral edges of the peripheral surface. As the size becomes smaller, the connecting portion between the valve member and the housing also has to be made smaller. Therefore, there is concern that physical strength and manufacturing may become difficult, and the strength of the connecting portion may be weakened. In addition, the connector of Cited Document 3 also has the same concern about downsizing, such as the need for a space such as a gap. In addition, providing a slit as an opening of a small-diameter valve member may cause inconveniences such as a lack of elongation against pressure due to a relative decrease in elastic members, etc., and the slit serving as the opening being easily damaged. considered.

Accordingly, the present invention provides a connector used for connecting a male tapered portion of a syringe or the like to an infusion line, in which connection of the male tapered portion to the connector does not contaminate the fluid passage, and a new small-diameter standard is provided. The object of the present invention is to provide a medical connector that can be safely and reliably applied to

A medical connector of the present invention is a connector for connecting a male tapered portion of a syringe or the like to an infusion line, comprising a valve member made of an elastic member that opens and closes a passage to the infusion line by inserting and removing the male tapered portion; The valve member includes a housing made of a hard material, the upper surface and a part of the outer peripheral surface of which are firmly attached to the valve member.

The following parts are preferably formed as follows.
- A needle hole mark is provided at the center of the upper surface of the valve member as an opening setting portion for forming a through hole by inserting the male tapered portion.
- The needle hole mark that becomes the opening setting portion is formed by penetrating a needle tube having a conical tip.
- The inner diameter of the opening in the upper surface of the housing is formed to be 3.6 mm or more and 3.9 mm or less.
- The valve member and the housing are integrally formed by two-color molding.

Further, when the male taper portion is inserted into the connector and a passage to the infusion line is formed, the outer peripheral surface of the male taper portion does not come into contact with the passage to the infusion line.

(action)
According to this means, the valve member is formed in such a manner that the cap is attached to the housing, and the upper surface and the outer peripheral surface of the housing are firmly attached to each other, so that a mechanism for holding the valve member within the housing is required. Therefore, it is possible to easily form a small-diameter connector. Further, when the male tapered portion is pushed into the valve member to be inserted, the valve member made of the elastic member is stretched substantially only in the axial direction of the valve, and the deformation of the valve member due to pressure is stabilized. .

Further, by making the opening setting part opened by inserting the male tapered part into a needle hole mark, the passage to the infusion line is not opened more than necessary, and the needle hole mark on the tapered distal end part is prevented. can be set very small, the male tapered tip only presses against the upper surface of the valve member and does not directly contact the inside of the opening setting. Furthermore, by using a conical needle tube at the tip to form the needle hole mark, the through hole becomes circular. The risk of damage to the valve member is reduced because no tearable parts are formed as at the ends of the valve.

By setting the inner diameter of the opening on the upper surface of the housing to 3.6 mm or more and 3.9 mm or less, it is possible to connect and hold a new standard connector for the field of neuraxial anesthesia. It is possible to prevent the connection of the male tapered portion of the.

By integrally forming the valve member and the housing by two-color molding, the upper surface and part of the outer peripheral surface of the housing can be securely fixed to the corresponding connecting portion of the valve member, and the male taper portion can be connected to the valve member. There is no concern that the connecting part will come off even when pressed. In addition, since no other means such as a holding portion is required for fixing the valve member to the housing, the structure is simple and the manufacture is easy. Furthermore, since the connection portion of the connector can be formed with a small diameter, it can be applied to a small-diameter connector required by the new standard.

When the male tapered portion is inserted into the connector constructed by the above means and a passage to the infusion line is formed, the distal end surface of the male tapered portion has the possibility of foreign matter adhering or contamination in the passage to the infusion line. By not contacting the infusion line, the inside of the infusion line will not be dirty, and the portion where residual liquid may remain after the male taper is removed is a flat valve member that will be the contact surface with the male taper. Since it is only the top surface, it can be easily removed and sterilized, and since it can be kept clean, the inside of the infusion line will not be contaminated even when the male tapered portion is reconnected.

According to the present invention, in a connector used for connecting a male tapered portion of a syringe or the like to an infusion line, the connection of the male tapered portion to the connector does not contaminate the inside of the infusion line, and the male tapered portion It is possible to provide a medical connector that allows safe and reliable connection, is easy to configure and manufacture, and conforms to the small-diameter connector standard required in the new field of nerve anesthesia.

BRIEF DESCRIPTION OF THE DRAWINGS Sectional drawing which shows the structure of the medical connector which shows an example of embodiment of this invention. FIG. 2 is an overall configuration diagram showing a branch tube provided in the middle of an infusion line to which the medical connector of the above configuration is attached. FIG. 4 is a partial cross-sectional configuration diagram showing the front and top surfaces of the branch pipe; FIG. 4 is a partial cross-sectional front view and top view showing a plug-in type connector to which the medical connector of the above configuration is attached; The schematic diagram which shows the state of insertion of the male taper part to the branch pipe of the said embodiment. (before connection) The schematic diagram which shows the state of insertion of the male taper part to the branch pipe of the said embodiment. (connecting) The schematic diagram which shows the state of insertion of the male taper part to the branch pipe of the said embodiment. (after connection) Sectional view showing the standard size of the male taper of the international standard (ISO80369-6 standard) for small diameter connectors in the field of neuraxial anesthesia.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the medical connector of the present invention will be described in detail with reference to the drawings.
The medical connector of this example is, for example, a connector used for mixed injection of injecting another liquid medicine in one shot into an infusion line that continuously injects a liquid medicine or the like for a long period of time. is configured as a connector with a branch line for connecting the male tapered portion of the Although the drug used and the application are not specified, in this example, it is particularly suitable for mixed injection of anesthetics, and the size and structure are a male taper that conforms to the international standard ISO 80369-6 for small diameter connectors in the field of nerve anesthesia. It is formed as a female connector that can be inserted and removed.

Before describing the embodiments of the present invention, the size of the male tapered portion defined in ISO80369-6 that can be connected to the connector of this example will be briefly described. The male taper part of this standard has a lock type connector equipped with a locking mechanism (lock ring) that secures the connection with the female taper part by screws, and a collar without a locking mechanism around the male taper part. Although the slip-type connector to be provided is standardized, only an example of the slip-type connector will be described here as a representative example. It should be noted that the connector of the present invention does not exclude locking connectors.

FIG. 8 shows a slip type male connector of international standard ISO 80369-6 for connectors in the field of neuraxial anesthesia 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. The sizes of each portion of the male taper 40 are as follows.
- Taper angle 5/100.
(Hereafter, the unit is mm, the minimum value (nominal value) and the maximum value are listed in order)
• Recess or protrusion of connector tip (male tapered portion 41) from collar 42 -4(0)+4.
· Male taper tip outer diameter (a) 3.17 (3.21) 3.25 at a position of 0.5 mm (reference dimension) from the male taper tip.
• Male taper tip inner diameter (b) - (1.15) 2.3.
· Male taper big end outer diameter (c) 3.45 (3.51) 3.57 at a position of 6.5 mm (reference dimension) from the tip of the male taper.
• Inner collar diameter (d) 6.75 (6.875) 7.0.
· Connector length (g) from male taper tip is 8.0 (8.3).
• The inner diameter of the fluid lumen of the connector (f) - (1.15) 2.3.
• Diameter of the smallest cylinder surrounding the outer circumference of the collar outer feature (e) 9.8 (10.5) 11.5.
It has become.

On the other hand, the size of each part of the luer taper standard (ISO80369-7) is as follows.
- Taper angle 6/100.
• Male taper tip outer diameter 3.97 (4.021) 4.07 at 0.75 mm (reference dimension) position from male taper tip.
• Male taper tip inner diameter - (2.1), 2.9.
• Male taper big end outer diameter 4.376 (4.426) 4.476 at a position of 7.5 mm (reference dimension) from the tip of the male taper.
• Male taper length 7.5 (8.4) 10.5.
The taper of the new nerve anesthesia field standard (ISO80369-6) has an outer diameter of about 0.8 mm at the tip and about 0.9 mm at the big end compared to the luer taper. Even if the male taper does not have a locking mechanism, the standard requires that the collar be provided with a collar that is approximately the same height (within 0±0.4 mm) as the taper portion.

FIG. 1 is a structural sectional view of a medical connector showing an example of an embodiment of the present invention, FIG. 2 is an overall structural diagram of a branch pipe connector to which the medical connector is attached, and FIG. A partial cross-sectional front view (B) and a top view (A) are shown.
As described above, the medical connector (female connector) 10 of this embodiment is a connector with a valve attached to the side tube side of the branch tube connector 20 provided in the middle of the infusion line. A valve member 11 for opening and closing a passage to an infusion line by inserting and withdrawing the valve member 11, and a housing 12 to which the valve member 11 is fixed with a cap attached to the tip side thereof.

The valve member 11 is selected from a material (styrene-based elastomer in this example) having high elasticity and rubber elasticity, such as isoprene rubber, silicone rubber, natural rubber, thermoplastic elastomer, etc., and is formed substantially flat. The upper surface of the valve member 11 and the valve peripheral surface 112, which serves as the side surface, form a cylindrical cap shape. The center portion of the upper surface is formed as a pressed portion 111 which is a contact portion with the tapered portion and is thicker than the edge portion of the upper surface. A needle hole mark 13 is provided. A peripheral portion formed thinner than the pressed portion 111 is formed in a circular groove shape, and is fitted to the front end side of the housing 20 to be described later, and serves as a solid contact portion with the upper surface 123 of the housing. On the other hand, the valve peripheral surface 112 is formed in a cylindrical shape with substantially the same thickness as the groove portion of the upper peripheral portion, and the inner surface of the valve peripheral surface 112 serves as a fixed contact portion with the housing 12 .

The needle hole mark 13 serving as an opening setting portion provided at the center of the pressed portion 111 is a through hole mark formed in a cylindrical shape, and is closed by the elasticity of the valve member 11 in a natural state to keep the infusion line airtight. When the male tapered portion 41 is pressed against the pressed portion 111 and inserted, the valve member 11 is stretched and deformed, and the needle hole mark 13 opens to become a passage to the infusion line. The needle hole marks 13 are formed on the valve member 11 by penetrating a needle tube with a conical tip through the center of the pressed portion 111. In this example, a needle tube with a conical point having a diameter of 0.76 mm is used. Ta.

The housing 12 is made of hard resin capable of retaining its shape, for example, a thermoplastic resin such as polypropylene, polyethylene, polycarbonate, polystyrene, or polyacetal (polypropylene in this example), and is formed into a cylindrical shape with a plurality of steps. The tip-side tubular portion 121 of the housing 12 is the small-diameter side to which the valve member 11 is attached, and the valve crown-attaching portion 122 is formed thin by the thickness of the valve peripheral surface 112 of the valve member 11. When the member 11 is crowned, it is formed so as to form a cylinder having the same outer diameter without steps. Further, the edge portion of the tip protrudes slightly inward to form a housing upper surface 123 . The distal end side tubular portion 121 may be formed in a size suitable for the form of the male taper to be inserted. The inner diameter of the portion is set to 3.6 mm or more that allows passage of 3.570 mm, which is the maximum dimension of the outer diameter of the male taper portion 41 of the standard, and 3.9 mm, which cannot be inserted into the 3.97 mm that is the minimum dimension of the male luer taper standard. It is formed in the following range. (The specific inner diameter of the distal end in this example is 3.6 mm, and the inner diameter of the portion other than the distal end is 4.0 mm). In order to fit within the standard collar 42 of the small-diameter male taper 41, the inner diameter of the collar 42 is smaller than the Min value of 6.75 mm. (Specific outer diameter of 6.2 mm in this example) Further, the depth of the lumen space 14 of the small-diameter inner cylindrical portion is about 6.5 mm, which is the maximum insertion length of the small-diameter male taper standard taper. set large. (specific depth 7.5 mm in this example)

On the other hand, the proximal cylindrical portion 124 of the housing 12 is on the large diameter side to be fitted to the side pipe wall 25 described later of the branch pipe connector 20, and the marginal portion of the end portion slightly protrudes inward to form the lower surface of the housing. be. The proximal tubular portion 124 may be formed in a size suitable for the shape of the side pipe to which it is fitted. It was 10.5 mm and the depth of the lumen was 5.4 mm. By providing a step between the tip side tubular portion 121 and the base side tubular portion 124, when the male taper portion 41 is inserted deeply, the shoulder portion 125 of the step and the collar 42 of the tapered portion come into contact with each other, resulting in a taper. Excessive insertion of the part can be prevented.

The valve member 11 is attached to the housing 12, and the upper surface portion 123, which is the distal end portion of the housing 12, and the pressed portion 111 of the valve member 11, which is formed thick, have a slight amount of A clearance 15 is provided, which serves as an escape space that can be slightly extended to the peripheral surface side by pressing from the male tapered portion 40 . Although the valve member 11 and the housing 12 can be capped by adhesion or the like, the styrene elastomer forming the valve member 11 and the polypropylene forming the housing 12 are integrally formed by two-color molding. As a result, the rear surface of the peripheral portion of the upper surface of the valve member 11 and the upper surface 123 of the housing, and the inner surface of the peripheral surface 112 of the valve member and the valve crown mounting surface 122 of the housing are displaced or damaged by the pressure of the male taper 40. It becomes a fixed structure that does not move.

The female connector 10 formed as described above is fitted to the side pipe wall 25 forming the side pipe route 27 of the branch pipe connector 20 . The branch pipe connector 20 of this example is also formed by applying the above-described small diameter connector standard (ISO80369-6) in the field of nerve anesthesia. 21, a small-diameter male tapered portion 22 provided on one side of the main pipe route, a small-diameter female tapered portion 24 provided on the other side, and a side pipe forming a side pipe route branched by the branch pipe main body 21. A lock ring 23 was attached to the male tapered portion 22 to fix the corresponding female tapered portion.

The male taper portion 22 and the female taper portion 24 are connected to tubes or the like connected with connectors having corresponding female tapers and male tapers, respectively, and are fixed by a lock ring 23 . are connected by bonding 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 tapered portion including a branch, not to be connected only to the branch of the infusion line as described above. Similar to the tube connector 20, it is formed by applying the standard for small diameter connectors (ISO80369-6) in the field of neuraxial anesthesia. The plug-in connector 30 is composed of a male tapered portion 31 with a lock 32 conforming to the standard, and a connecting portion 33 provided at the base of the male tapered portion 31 for connection with the female connector 10 of the present invention. Similar to the connector 20, the female connector 10 of the present invention is connected to the connecting portion 33 by an adhesive or the like.

5 to 7 are schematic diagrams showing how to insert a male tapered portion conforming to the small diameter connector standard (ISO80369-6) in the field of neuraxial anesthesia into the medical connector of the present invention, and FIG. 5 is before insertion. FIG. 6 shows the state of insertion, and FIG. 7 shows the state of insertion.

Before the male taper portion 41 of the syringe 50 is connected to the female connector 10, the needle hole mark 13, which serves as the opening setting portion provided on the valve member 11, is in a closed state, and the infusion line is reliably maintained in an airtight state. there is

When the tip of the male tapered portion 41 is pushed into the pushed portion 111 of the valve member 11 of the female connector 10 , the valve member 11 is elastically stretched and pushed down into the inner cavity 14 of the housing 12 , and the central portion of the pushed portion 11 is pushed down. The needle tube mark 13 provided in the is gradually pushed out and opened.

When the male tapered portion 41 is further pushed into the female connector 10, and the tapered collar 42 is pushed to the extent that it contacts the shoulder portion 125 of the housing 12 and is completely inserted, the pressed portion 111 of the valve member 11 is It extends further and is pushed into the lumen space 14 of the housing 12, and the needle hole mark 13 is pulled around and opened to form an opening 131 that communicates with the infusion line. At this time, since the tip opening of the male tapered portion 41 is formed to be larger than the opening 131 of the needle hole mark 13, the tip surface of the taper only presses the upper surface of the pressed portion 111 of the valve member 11. No contact with infusion lines.

According to the medical connector of the present embodiment, by adopting a structure in which the valve member 11 is attached to the housing 12 in a cap shape, there is no need for a clamping portion or the like in the housing as a structure for attaching the valve member to the housing. The insertion portion with the male tapered portion can be formed to have a small diameter. Further, by two-color molding the connection between the valve member 11 and the housing 12, it is possible to ensure the fixation between the members even with the above-described crown attachment structure. As a result, it can be safely and reliably applied to the male taper portion of the connector standard (ISO80369-6) in the field of neuraxial anesthesia, which is a taper standard with a smaller diameter than before.

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 diameter smaller than that of the opening of the male taper portion 41, so that the opening of the opening 131 is closed. Since the force applied to the peripheral surface of the hole mark 13 is uniform and there is no portion with weak strength like the end of the slit, there is no risk of damage to the valve member 11 even if a large pressure is applied during insertion. is small. In addition, the surface portion including the distal end surface of the male tapered portion 41, which may become an unclean portion, is in physical contact with the housing inner space 14 and the surface of the opening portion 131 of the valve member 11, which are part of the chemical solution line. There is no need to contaminate the chemical line. In addition, since the portion to which residual liquid that may cause contamination after chemical injection, etc. may adhere is limited to the upper surface of the valve member 11 formed substantially flat, residual liquid removal and sterilization can be performed. It is easy to use, and the risk of infection, etc., can be reduced even when it is used multiple times as an injection port.

10. Medical connector 11 . valve member 111 . Pressed portion 112 . Valve peripheral surface 12 . housing 121 . tip side tube part 122 . Valve crown attachment portion 123/housing upper surface 124. Base tube portion 125 . shoulder 13 . Needle hole marks 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 route 27 . Side pipe route 30 . Plug-in connector 31 . (Plug) male tapered portion 32 . lock 33 . connection part 40 . Standard female connector (ISO80369-6)
41. male taper 42 . 4. Color Syringe

Claims (6)

A connector for connecting a male tapered portion to an infusion line, comprising:
a valve member made of an elastic member that opens and closes a passage to an infusion line by inserting and removing the male tapered portion;
A housing made of a hard member having an upper surface and a part of the outer peripheral surface fixed to the valve member,
A medical connector, characterized in that the valve member is formed in such a manner that a cap is attached to the housing. 2. The medical connector according to claim 1, wherein a center portion of the upper surface of said valve member is provided with a needle hole mark as an opening setting portion for forming a through hole by inserting said male tapered portion. 3. The medical connector according to claim 2, wherein the needle hole mark provided as the opening setting portion is formed by penetrating a needle tube having a conical tip. 4. The medical connector according to any one of claims 1 to 3, wherein the inner diameter of the opening in the upper surface of said housing is formed to be 3.6 mm or more and 3.9 mm or less. 5. The medical connector according to claim 1, wherein said valve member and housing are integrally formed by two-color molding. 6. The medical connector according to any one of claims 1 to 5, wherein when the male tapered portion is inserted into the connector to form a passageway to the infusion line, the outer peripheral surface of the male tapered portion does not come into contact with the passageway.

Images