JP6677912B2 - Male connector - Google Patents

Description

  The present invention relates to a male connector provided with a female screw on an inner surface of an outer cylinder surrounding a male luer.

  Enteral nutrition therapy is known as a method of administering nutrition and drugs to patients without oral administration. In enteral nutrition therapy, nutritional supplements and liquid food are fed through a nasal catheter inserted from the patient's nasal cavity to the stomach or duodenum or a PEG (Percutaneous Endoscopic Gastrostomy) catheter inserted into a gastric fistula formed in the patient's abdomen. Or a liquid such as a drug (commonly referred to as an "enteral nutritional supplement") is administered to the patient. The liquid to be administered to the patient is stored in a container. A flexible tube (hereinafter referred to as “container-side tube”) is connected to the outlet port of the container. The downstream end of the container tube is a catheter inserted into a patient (eg, a nasal catheter or a PEG catheter) or a flexible tube connected to the catheter (hereinafter, these are collectively referred to as “patient tube”). Connected to the upstream end of In general, a connector including a male connector and a female connector is used to connect the container-side tube and the patient-side tube (for example, see Patent Document 1).

  If the liquid administered in enteral nutrition therapy is a low-viscosity liquid, the liquid may flow back from the stomach into the esophagus, causing pneumonia, or diarrhea due to insufficient absorption of the liquid's water in the body. Or other problems. Therefore, in enteral nutrition therapy, the liquid material is often made to have a high viscosity (that is, semi-solidified) by adding a thickening agent or a thickening agent. Such a highly viscous liquid material has low fluidity, and therefore has a high resistance when passing through a tube. Therefore, when a highly viscous liquid is administered to a patient, the liquid is applied under pressure and fed.

  Therefore, it is desirable that the connecting device connecting the container-side tube and the patient-side tube has a lock mechanism that engages with each other so as to withstand the pressure applied to the liquid material. Therefore, it has been studied to standardize the male connector and the female connector used for such an application as the international standard ISO80369-3 on nutritional medical devices. As shown in FIGS. 4A and 4B, the male connector 910 considered as ISO80369-3 has a cylindrical male lure 911 and an outer cylinder 915 surrounding the male lure 911. The outer cylinder 915 is connected to the root of the male lure 911 via the bottom plate 913. The male lure 911 has a flow path 918 that penetrates the male lure 911 along the longitudinal direction. A female screw 916 is formed on the inner surface of the outer cylinder 915 facing the male lure 911. On the other hand, as shown in FIGS. 5A and 5B, the female connector 920 considered as ISO80369-3 has a cylindrical insertion portion (male luer) 921 into which the male lure 911 is inserted. A male screw 926 is formed on the outer peripheral surface of the insertion portion 921. The male connector 910 and the female connector 920 are connected by inserting the male luer 911 into the insertion portion 921 and screwing the female screw 916 and the male screw 926. Since the outer peripheral surface of the male luer 911 and the inner peripheral surface of the insertion portion 921 are tapered surfaces having the same taper angle, they are in liquid-tight surface contact. The female screw 916 and the male screw 926 screwed together constitute a lock mechanism for locking the connection state between the male connector 910 and the female connector 920. The male connector 910 and the female connector 920 are liquid-tight (the property that the liquid material does not leak from the connection portion between the male connector and the female connector even when pressure is applied to the liquid material) and the connection strength (with the connected male connector). (A property that the female connector does not separate from the female connector even when a tensile force is applied).

  International Standard ISO80369-3 considers providing a male connector 910 at the upstream end of the patient side tube and providing a female connector 920 at the downstream end of the container side tube.

International Publication No. 2008/152871 pamphlet

  In the male connector 910, an outer cylinder 915 surrounds the male lure 911, and a female screw 916 is formed on an inner surface of the outer cylinder 915. Therefore, the enteral nutrient is likely to adhere to the surface that defines the gap 914 between the male lure 911 and the outer cylinder 915, particularly to the valley and the bottom plate 913 of the female screw 916. Once the enteral nutrient adheres to the valley or bottom plate 913 of the female screw 916, it is difficult to wipe off and remove the enteral nutrient.

  When the patient-side tube provided with the male connector 910 is a catheter inserted into a patient, the male connector 910 is kept in the patient together with the catheter. In the case of a PEG catheter, the replacement of the catheter is usually performed every 1 to 3 months. If the male connector 910 to which the enteral nutrient is attached is kept in the patient for such a long time, the male connector 910 may be in an unsanitary state. Eventually, bacteria may multiply in the male connector 910, and the bacteria may enter the patient's body, causing serious complications.

  An object of the present invention is to improve the cleaning performance of a male connector in which a female screw is formed on the inner surface of an outer cylinder surrounding a male luer.

The male connector of the present invention includes a cylindrical male luer having a flow path formed therein, a bottom plate protruding outward from a root of the male luer in a radial direction, and an outer cylinder provided on the bottom plate and surrounding the male luer. A female screw formed on an inner surface of the outer cylinder facing the male luer, and a proximal end having a cylindrical shape communicating with the flow path, which is fixed to an upstream end of a tube used for enteral nutrition therapy. And a base end. A through hole is formed in the bottom plate to allow a gap between the male luer and the outer cylinder to communicate with the outside of the male connector. The through-hole is a cleaning hole for allowing a cleaning liquid to flow into and out of the gap through the through-hole to remove dirt attached to a surface defining the gap. The male luer and the female screw conform to ISO80369-3

  ADVANTAGE OF THE INVENTION According to this invention, a male connector can be wash | cleaned by making a washing | cleaning liquid flow into the space | gap between a male luer and an outer cylinder via the through-hole formed in the bottom plate. Therefore, the male connector of the present invention has improved cleaning properties.

FIG. 1A is a perspective view of a male connector according to an embodiment of the present invention as viewed from above. FIG. 1B is a perspective view of the male connector according to the embodiment of the present invention as viewed from below. FIG. 1C is a sectional view of the male connector according to one embodiment of the present invention. FIG. 2 is a perspective view of a male connector according to another embodiment of the present invention as viewed from below. FIG. 3 is a perspective view of a male connector according to still another embodiment of the present invention as viewed from below. FIG. 4A is a perspective view of a male connector considered as ISO80369-3. FIG. 4B is a cross-sectional view along a plane including the central axis of the male connector. FIG. 5A is a perspective view of a female connector being considered as ISO80369-3. FIG. 5B is a cross-sectional view along a plane including the central axis of the female connector.

  In the male connector of the present invention described above, the outer cylinder may further include a through hole extending along a valley of the female screw. Thereby, the amount of dirt adhering between the screw threads can be reduced. Further, the dirt adhering between the screw threads can be easily removed by a cleaning liquid or air flowing from a through hole formed in the vicinity thereof.

  The total opening area of the through holes is preferably 20% to 80% of the total inner surface area of the outer cylinder and the bottom plate. Thereby, the cleanability of the male connector can be further improved while securing the strength of the male connector.

  The through-hole may have a portion whose inner dimension becomes smaller as approaching a gap between the male luer and the outer cylinder. Preferably, the portion is provided in a region (outside region) including an opening edge outside the through hole. This makes it easier to spray the cleaning liquid or air into the gap from the outside through the through hole, so that the cleaning properties of the male connector are further improved. Further, dirt on the inner peripheral surface of the through hole is easily wiped off from the outside.

  Alternatively, the through hole may have a portion whose inner dimension increases as approaching the gap between the male luer and the outer cylinder. Preferably, the portion is provided in a region (gap side region) including an opening edge on the gap side (inside) of the through hole. This makes it easier for the dirt in the gap to flow out of the gap through the through hole.

  The male luer and the screw protrusion may conform to ISO80369-3. Thereby, the male connector of the present invention can be connected to a female connector compliant with ISO80369-3 with liquid tightness and connection strength according to ISO80369-3.

  The male connector of the present invention is preferably provided and used at the upstream end of a tube used for enteral nutrition therapy.

  Hereinafter, the present invention will be described in detail with reference to preferred embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. In the drawings referred to in the following description, for convenience of explanation, of the members constituting the embodiment of the present invention, only the main members necessary for explaining the present invention are simplified. Accordingly, the present invention may include any members not shown in the following figures. In the following drawings, the actual dimensions of the members and the dimensional ratios of the respective members are not faithfully represented.

  FIG. 1A is a perspective view of a male connector 1 according to an embodiment of the present invention as viewed from above. FIG. 1B is a perspective view of the male connector 1 as viewed from below. FIG. 1C is a cross-sectional view of the male connector 1 along a plane including the central axis 1a. For convenience of the following description, the direction parallel to the central axis 1a is the “up-down direction”, the upper side of the paper of FIGS. 1A to 1C is “the upper side” of the male connector 1, and the lower side of the paper of FIG. 1 is referred to as the "lower side". A direction parallel to a plane perpendicular to the central axis 1a is referred to as a “horizontal direction”. Further, a direction rotating around the central axis 1a is referred to as a “circumferential direction”, and a direction orthogonal to the central axis 1a is referred to as a “radial direction”. However, “vertical direction” and “horizontal direction” do not mean the orientation when the male connector 1 is used.

  The male connector 1 includes a cylindrical male luer 11 at one end and a base end 19 at the other end along the central axis 1a. A channel 18 extends through the male connector 1 from the male luer 11 to the proximal end 19 along the central axis 1a.

  The outer peripheral surface 12 of the male luer 11 is a tapered surface (conical surface) whose outer diameter decreases as approaching the front end (upper end). From the root of the male lure 11, a disk-shaped bottom plate 13 projects outward in the radial direction. In other words, the male luer 11 projects upward from the center of the bottom plate 13 along the central axis 1a.

  An outer cylinder 15 is provided at an outer peripheral end of the bottom plate 13. The outer cylinder 15 has a hollow, substantially cylindrical shape coaxial with the male luer 11, and surrounds the male lure 11. The outer cylinder 15 is radially separated from the male luer 11 via a gap 14. On the inner surface of the outer cylinder 15 facing the male luer 11, a female screw 16 is formed as a screw-like projection.

  The male luer 11 and the female screw 16 surrounding the male luer 11 conform to the male connector 910 (FIGS. 4A and 4B) of ISO80369-3 described above. Therefore, the male connector 1 can be connected to the female connector 920 (FIGS. 5A and 5B) based on ISO80369-3.

  The base end 19 has a hollow cylindrical shape. In FIG. 1C, a two-dot chain line 9 is a hollow tube inserted into and fixed to the base end portion 19. The channel 18 of the male connector 1 communicates with the tube 9.

  Four first through holes 21 penetrating the outer cylinder 15 in the radial direction are formed in the outer cylinder 15. As best shown in FIG. 1C, the first through-hole 21 extends along the female screw 16 between the threads of the female screw 16 adjacent to the center axis 1a (that is, the valley of the female screw 16). ing. The inner dimensions of the first through hole 21 in the circumferential direction and the vertical direction are constant in the through direction (that is, the radial direction) of the first through hole 21.

  As shown in FIGS. 1B and 1C, four second through holes 22 penetrating the bottom plate 13 in the vertical direction are formed in the bottom plate 13. The second through hole 22 extends along an arc coaxial with the central axis 1a. As best shown in FIG. 1C, the radial inner dimension of the second through-hole 22 decreases as it approaches the gap 14 (ie, the upper side).

  The male connector 1 is made of a hard material (hard material) and has a mechanical strength (rigidity) that is not substantially deformed by an external force. Examples of such a hard material include, but are not limited to, polypropylene (PP), polycarbonate (PC), polyacetal (POM), polystyrene, polyamide, polyethylene, hard polyvinyl chloride, and ABS (acrylonitrile-butadiene-styrene copolymer). ) Can be used. The male connector 1 can be integrally manufactured by an injection molding method or the like using the above resin material.

  A method of using the male connector 1 of the present embodiment will be described. The case where the male connector 1 is provided at the upstream end of the PEG catheter will be described as an example. That is, the tube 9 indicated by the two-dot chain line in FIG. 1C is a PEG catheter. The downstream end of the tube 9, not shown, is inserted into the stomach of the patient. The male connector 1 is placed in the patient together with the tube 9.

  When performing enteral nutrition therapy, the male connector 1 is connected to a female connector connected to the downstream end of a tube (container-side tube) connected to the container storing the enteral nutrient. The female connector is a female connector 920 (FIGS. 5A and 5B) based on ISO80369-3. The connection between the male connector 1 and the female connector 920 can be performed by inserting the male luer 11 into the insertion portion 921 and screwing the female screw 16 and the male screw 926. The outer peripheral surface 12 of the male luer 11 is a tapered surface having the same taper angle as the inner peripheral surface of the insertion portion 921. Therefore, both surfaces make a liquid-tight surface contact. The connection between the male connector 1 and the female connector 920 is excellent in liquid tightness and connection strength, similarly to the connection between the male connector 910 (FIGS. 4A and 4B) and the female connector 920. While the male connector 1 and the female connector 920 are connected, the enteral nutrition is administered to the patient via the channel 18 and the tube 9.

  Thereafter, the female connector 920 is separated from the male connector 1. After the female connector 920 is separated, the male connector 1 may be stained with an enteral nutrient or the like. It is difficult to wipe and remove the surface that defines the gap 14, in particular, the dirt attached to the outer peripheral surface 12 of the male luer 11, the valley of the female screw 16, and the upper surface of the bottom plate 13. Then, the male connector 1 is washed. The method for cleaning the male connector 1 is not limited. For example, the male connector 1 can be immersed in the cleaning liquid stored in the container having an open top and rinsed. Alternatively, a cleaning liquid or air may be injected from the outside into the gap 14 through the through holes 21 and 22 to remove dirt attached to the surface defining the gap 14. The washing liquid is not limited, but for example, lukewarm water, water, tea, diluted vinegar water and the like can be used.

  Compared with the conventional male connector 910 (FIGS. 4A and 4B), the male connector 1 of the present embodiment has an opening communicating with the gap 14 in addition to the opening above the outer cylinder 15 (the side opposite to the bottom plate 13). , A first through hole 21 and a second through hole 22. Therefore, when the male connector 1 is rocked in the cleaning liquid, the cleaning liquid flows into and out of the gap 14 via the first through hole 21 and the second through hole 22 in addition to the upper opening of the outer cylinder 15. For this reason, a larger flow of the cleaning liquid is generated in the gap 14, so that dirt attached to the surface of the male connector 1 that defines the gap 14 is easily removed. Further, when the cleaning liquid or the air is injected into the gap 14 through the first through hole 21 and the second through hole 22, the cleaning liquid or the air is injected into the gap 14 through the upper opening of the outer cylinder 15. In this case, dirt that cannot be removed can be removed. The dirt removed from the surface defining the void 14 flows out of the male connector 1 through the first through hole 21 and the second through hole 22 together with the cleaning liquid or air in addition to the upper opening of the outer cylinder 15. Therefore, it is difficult for dirt to adhere to the male connector 1 again.

  As described above, in the male connector 1 of the present embodiment, the first through-hole 21 is formed in the outer cylinder 15 and the second through-hole 22 is formed in the bottom plate 13, so that the conventional male connector 910 (see FIGS. 4A and 4A). As compared with FIG. 4B), the surface defining the gap 14 can be cleaned more easily and more cleanly. The cleaning operation of the male connector 1 can be performed with the male connector 1 attached to the upstream end of the tube 9 placed in the patient.

  As the number of the first through holes 21 and the second through holes 22 increases and the opening area thereof increases, the cleaning property of the male connector 1 improves. Generally, the total opening area of the first through-hole 21 and the second through-hole 22 is not limited with respect to the total area of the inner surface of the outer cylinder 15 and the inner surface of the bottom plate 13 that defines the gap 14 (total inner surface area). It is preferably at least 20%, more preferably at least 30%. Here, the area of the inner surface of the outer cylinder 15 is the inner surface of the outer cylinder 15 assuming that there is no thread of the female screw 16 (this usually corresponds to a cylindrical surface having a diameter equal to the root diameter of the female screw 16). Defined by Further, the opening area of each of the through holes 21 and 22 is defined at a position where the inner dimension becomes minimum when the inner dimension changes in the through direction. The total opening area is obtained by adding the opening areas of all the through holes 21 and 22 provided in the male connector 1. If the ratio of the total opening area of the through holes 21 and 22 to the total inner surface area is smaller than the above numerical range, the cleanability of the male connector 1 is reduced.

  However, the ratio of the total opening area of the through holes 21 and 22 to the total inner surface area is not limited, but is preferably 80% or less, and more preferably 70% or less. If the total opening area is larger than this, the strength of the male connector 1 decreases, and the male connector 1 is easily damaged.

  The first through hole 21 is preferably formed between adjacent screw threads of the female screw 16 formed in the outer cylinder 15 (that is, a valley of the female screw 16). As described above, dirt easily adheres between the threads of the female screw 16, and it is difficult to remove dirt once it adheres between the threads. By forming the first through holes 21 between the screw threads, the amount of dirt attached to the female screw 16 can be reduced. Further, the dirt adhering between the screw threads can be easily removed by the cleaning liquid or air flowing from the first through hole 21 formed in the vicinity thereof. Therefore, forming the first through holes 21 between the threads of the female screw 16 is advantageous for preventing the male connector 1 from being stained and for improving the cleanability of the male connector 1. However, the present invention is not limited to this, and the first through hole 21 may be formed in the thread of the female screw 16. However, it is necessary to secure the female screw (screw projection) 16 to be screwed with the male screw 926 of the female connector 920 (FIGS. 5A and 5B).

  The inner dimensions of the through holes 21 and 22 may be constant or change in the through direction.

  For example, like the second through-hole 22 of the above embodiment, the inner size of the through-hole may change so as to become smaller as approaching the gap 14. When the inner peripheral surface of the through-hole is a tapered surface having a large diameter on the outside (opposite to the gap 14), the cleaning liquid or compressed air can be easily injected from the outside into the gap 14 through the through-hole. Therefore, the cleaning property of the male connector 1 is further improved. Further, dirt on the inner peripheral surface of the through hole is easily wiped off from the outside. Such a tapered surface having a large diameter on the outside may be provided only in a part (outside region) including the outside end of the inner peripheral surface of the through hole in the penetration direction.

  Alternatively, contrary to the above, the inner size of the through-hole may be changed so as to increase as approaching the gap 14. When the inner peripheral surface of the through hole is a tapered surface having a large diameter on the side of the gap 14 (inside), dirt in the gap 14 easily flows out of the gap 14 through the through hole. Such a tapered surface having a large diameter on the side of the gap 14 may be provided only in a part (gap 14 side region) of the inner peripheral surface of the through hole including the end on the gap 14 side in the penetration direction.

  Further, the through-hole is such that the inner dimension of the through-hole changes so as to become smaller as it approaches the gap 14 (a tapered surface having a large diameter on the outside), and the inner dimension of the through-hole increases as it gets closer to the gap 14. May be provided (a tapered surface having a large diameter on the space 14 side) and a portion in which the inner size of the through hole is constant in the through direction. For example, the through-hole may have a tapered surface with a large diameter on the outside in a region outside in the penetration direction, and a tapered surface with a large diameter on the gap 14 side in a region on the gap 14 side in the penetration direction.

  In the above embodiment, the female screw 16 is a so-called continuous screw whose thread is continuous in the circumferential direction of the outer cylinder 15. Such a continuous screw can be screwed tightly with the male screw 926 of the female connector 920 (FIGS. 5A and 5B). However, the present invention is not limited to this, and a so-called discontinuous screw in which the thread of the female screw 16 is divided in the circumferential direction of the outer cylinder may be used. In this case, since it is easy to remove dirt in a portion where there is no screw thread, the cleanability of the male connector 1 is further improved. By forming the first through hole 21 in the thread of the female screw 16, the female screw 16 may be a discontinuous screw.

  The shapes, dimensions, numbers, and arrangement positions of the through holes 21 and 22 are not limited to the above-described embodiment, and can be arbitrarily changed. For example, the first through-hole 21 may extend in the outer cylinder 15 in parallel with the central axis 1a. The second through hole 22 may extend in the bottom plate 13 along the radial direction. The through holes 21 and 22 need not be long holes, and may be, for example, circular or square. The through hole may extend continuously from the outer cylinder 15 to the bottom plate 13. The through hole may extend along the boundary between the outer cylinder 15 and the bottom plate 13. It is not necessary that both the outer cylinder 15 and the bottom plate 13 have through holes. For example, as shown in FIG. 2, the through-hole (first through-hole) 21 may be formed only in the outer cylinder 15, and the through-hole may not be formed in the bottom plate 13. Alternatively, as shown in FIG. 3, the through-hole (second through-hole) 22 may be formed only in the bottom plate 13 and the through-hole may not be formed in the outer cylinder 15.

  In the above embodiment, the male connector 1 was provided at the upstream end of a so-called “tubular” PEG catheter that was long extended from the patient. However, the tube 9 provided with the male connector 1 of the present invention is not limited to this, and may be any tube used for enteral nutrition therapy for flowing an enteral nutritional supplement. For example, the tube 9 may be a tube connected to a so-called “button” PEG catheter that is not substantially drawn out of the patient. Alternatively, tube 9 may be a nasal catheter.

  The tube 9 generally has flexibility. The material of the tube 9 is not limited, and a known material for a tube used in enteral nutrition therapy can be used. In general, a soft material having rubber-like elasticity (a so-called elastomer) can be used. For example, natural materials such as natural rubber, isoprene rubber, and silicone rubber, and styrene-based elastomers, olefin-based elastomers, and polyurethane-based elastomers can be used. A plastic elastomer, soft polyvinyl chloride, or the like can be used.

  The method of fixing the base end portion 19 and the tube 9 is not limited, and any method such as adhesion and welding can be used. In the above-described embodiment, the tube 9 is inserted into the base end portion 19, but the base end portion 19 may be inserted into the tube 9 on the contrary. The male connector 1 may be detachable from the tube 9.

  INDUSTRIAL APPLICABILITY The present invention can be widely used as a male connector provided at an upstream end of a tube used for enteral nutrition therapy. In particular, it can be preferably used as a male connector provided at the upstream end of a PEG catheter (tube-type PEG catheter) which is kept in a patient for a long time.

DESCRIPTION OF SYMBOLS 1 Male connector 9 Tube 11 Male luer 13 Bottom plate 14 Gap between male lure and outer cylinder 15 External cylinder 16 Female screw (screw projection)
18 Channel 19 Base end 21, 22 Through hole

Claims (3)

A cylindrical male luer with a flow path formed therein,
A bottom plate protruding outward along the radial direction from the root of the male lure;
An outer cylinder provided on the bottom plate, surrounding the male lure,
A female screw formed on the inner surface of the outer cylinder facing the male luer,
A male connector having a proximal end having a tubular shape communicating with the flow path and a proximal end fixed to an upstream end of a tube used for enteral nutrition therapy,
The bottom plate is formed with a through hole that allows a gap between the male luer and the outer cylinder to communicate with the outside of the male connector, and the through hole is provided with the cleaning liquid through the through hole with respect to the gap. hole der for washing to remove dirt attached to the surface defining the gap by out of the is,
The male connector , wherein the male luer and the female screw conform to ISO80369-3 .   The through hole has at least one portion including an outer end of an inner peripheral surface of the through hole in a through direction of the through hole in a portion in which an inner dimension of the through hole becomes smaller as approaching a gap between the male luer and the outer cylinder. The male connector according to claim 1, which is provided in a portion.   The through hole has a portion whose inner dimension increases as approaching the gap between the male luer and the outer cylinder, at least including a gap side end of an inner peripheral surface of the through hole in the through direction of the through hole. The male connector according to claim 1, wherein the male connector has a part.

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