JP6427919B2 - Syringe - Google Patents

Description

  The present invention relates to a syringe used for enteral nutrition therapy.

  Enteral nutrition therapy is known as a method for administering nutrition and drugs to patients without oral administration. In enteral nutrition therapy, a nutrient or liquid food is passed 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 the gastric fistula formed in the patient's abdomen. Or a liquid such as a drug (commonly referred to as “enteral nutrition”) is administered to the patient.

  A liquid substance to be administered to a patient is supplied from a syringe, a bag-like container, or the like. When the liquid is supplied from a syringe, the syringe is an upstream end of a PEG catheter, a flexible tube connected to the PEG catheter, or a nasal catheter (hereinafter collectively referred to as “patient side tube”). Connected to.

  If the liquid administered in enteral nutrition therapy is a low-viscosity liquid, the liquid regurgitates from the stomach to the esophagus, causing pneumonia, or diarrhea because the liquid water is not sufficiently absorbed by the body. There are problems such as. Therefore, in enteral nutrition therapy, the liquid material is often made highly viscous (ie, semi-solid) by adding a thromi agent or a thickener. Such a high-viscosity liquid material has low fluidity, and therefore has high resistance when passing through the tube. Therefore, when a liquid material having a high viscosity is administered to a patient, the liquid material is fed under pressure.

  Therefore, it is desirable that the connector for connecting the syringe and the patient-side tube includes a locking mechanism that engages with each other so as to withstand the pressure applied to the liquid material. Then, it is examined that the male connector and the female connector used for such an application are internationally standardized as an international standard ISO80369-3 regarding a nutritional medical device.

  As shown in FIGS. 8A and 8B, the male connector 910 considered as ISO 80369-3 includes a cylindrical male luer 911 and an outer cylinder 913 surrounding the male luer 911. The male luer 911 is formed with a flow path 917 penetrating the male luer 911 along the longitudinal direction thereof. A female screw 916 is formed on the inner peripheral surface of the outer cylinder 913 facing the male luer 911. On the other hand, as shown in FIGS. 9A and 9B, the female connector 920 considered as ISO 80369-3 has a cylindrical insertion portion (male luer) 921 into which the male luer 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 together. 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 that are 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 (property that liquid does not leak out from the connecting portion between the male connector and the female connector even when pressure is applied to the liquid) and connection strength (the connected male connector and Provides excellent connection with the female connector that does not separate even when a tensile force is applied.

  In the international standard ISO80369-3, it is considered to provide a male connector 910 at the upstream end of the PEG catheter and provide a female connector 920 at the mouth of the syringe.

International Publication No. 2008/152871 Pamphlet

  In the male connector 910, the outer cylinder 913 surrounds the male luer 911, and a female screw 916 is formed on the inner peripheral surface of the outer cylinder 913. Therefore, enteral nutrients easily adhere to the gap between the male luer 911 and the outer cylinder 913, particularly the valley of the female screw 916. Once the enteral nutrient is attached to the valley of the female screw 916, it is difficult to wipe off the enteral nutrient. If the enteral nutrient continues to adhere for a long period of time, the male connector 910 can become unsanitary. Finally, bacteria may propagate in the male connector 910, and the bacteria may enter the patient's body and cause serious complications. Therefore, it is desirable that the outer peripheral surface of the insertion portion 921 of the female connector 920 and the surface of the male screw 926 immediately before being connected to the male connector 910 be as hygienic as possible. Therefore, it is desirable to connect the male connector 910 and the female connector 920 after wiping off the liquid material adhering to the mouth of the syringe by collecting the liquid material such as enteral nutrient.

  However, the outer surface of the mouth portion of the syringe has irregularities due to the male screw 926 formed on the outer peripheral surface of the insertion portion 921, so that the liquid material is left unwiped so that the gap between the male lure 911 and the outer cylinder 913 There is a possibility of contaminating the air gap, particularly the valley of the female screw 916.

  The present invention provides a syringe that can be connected to a male connector of a patient-side tube and that can suppress contamination of a female medium of the male connector.

The syringe of the present invention is a syringe including an outer cylinder provided with a cylindrical main body and a mouth provided at one end of the main body,
The mouth includes a cylindrical body communicating with the lumen of the main body, and a male screw formed on the outer surface of the cylindrical body,
The cylindrical body is
An insertion portion disposed on the base end side of the cylindrical body from the male screw;
A fractured portion that is disposed closer to the distal end side of the cylindrical body than the male screw and extends in the circumferential direction of the cylindrical body;
And a wetted part that is disposed closer to the distal end side of the cylindrical body than the fractured part and can be separated from the cylindrical body by the fracture of the cylindrical body at the fractured part.

  The syringe of this invention can be connected with the male connector of a patient side tube by the said structure, and can suppress the contamination of the female screw of a male connector. Therefore, the enteral nutrient can be supplied to the patient in a sanitary manner.

FIG. 1 is a perspective view of an example of the syringe of the present invention. FIG. 2A is a side view of the syringe shown in FIG. 1. 2B is a cross-sectional view taken along line 2B-2B of the syringe shown in FIG. 2A. FIG. 3 is a partially enlarged view of the syringe shown in FIG. 2A. FIG. 4 is a partially enlarged view of the syringe shown in FIG. 2B. FIG. 5A is a partially enlarged view of the syringe showing a state in which the liquid contact portion is being separated from the cylindrical body in the syringe shown in FIG. 1. FIG. 5B is a partially enlarged view showing a state after the wetted part is separated from the cylindrical body in the syringe shown in FIG. 1. 6A is a partial side view of a PEG catheter that can be connected to the syringe shown in FIG. 1, and FIG. 6B is a cross-sectional view taken along line 6B-6B of the PEG catheter shown in FIG. 6A. FIG. 7 is a partial cross-sectional view illustrating a connection state between the syringe shown in FIG. 1 with the wetted part cut away and the male connector of the PEG catheter shown in FIG. 6A. FIG. 8A is a perspective view of a male connector being considered as ISO 80369-3. FIG. 8B is a cross-sectional view along a plane including the central axis of the male connector. FIG. 9A is a perspective view of a female connector considered as ISO 80369-3. FIG. 9B is a cross-sectional view along a plane including the central axis of the female connector.

  The syringe of this invention is a syringe containing the outer cylinder provided with the cylindrical main body and the opening provided in the end of the said main body. The mouth portion includes a cylindrical body communicating with the lumen of the main body, and a male screw formed on the outer surface of the cylindrical body. The cylindrical body is disposed on the proximal end side of the cylindrical body with respect to the male screw, and on the distal end side of the cylindrical body with respect to the male screw, and the circumferential direction of the cylindrical body And a wetted part that is disposed closer to the distal end side of the cylindrical body than the ruptured part and can be separated from the cylindrical body by the rupture of the cylindrical body at the ruptured part.

  In the syringe of the present invention, the cylindrical body of the mouth includes a liquid contact part on the tip side of the male screw. Therefore, the enteral nutrient can be collected without attaching the enteral nutrient to the surface of the male screw or the outer peripheral surface of the insertion portion. If the wetted part is not separated from the cylindrical body after the enteral nutrient is collected by the syringe, the male screw and the insertion part can function as a female connector. Since the enteral nutrient is not attached to the outer surface of the female connector as described above, the male connector and the female connector can be connected while suppressing the attachment of the enteral nutrient to the female screw of the male connector. Contamination of the male connector can be suppressed.

  In an example of the syringe of the present invention, it is preferable that the insertion portion and the male screw conform to ISO 80369-3. When the syringe of the present invention is in such a form, the syringe of the present invention can be connected to a male connector based on ISO 80369-3 with excellent liquid tightness and connection strength.

  Below, this invention is demonstrated in detail, showing suitable embodiment. However, the present invention is not limited to the following embodiments. The dimensions of the members in the following drawings do not faithfully represent the actual dimensions of the constituent members and the dimensional ratios of the members.

  1 is a perspective view of an example of the syringe of the present invention, FIG. 2A is a side view of the syringe shown in FIG. 1, and FIG. 2B is a cross-sectional view taken along line 2B-2B in FIG. 2A. . In FIG. 1, an alternate long and short dash line 1a is the central axis of the syringe 1, and the cross section of FIG. 2B includes the central axis 1a. As shown in FIG. 1, the syringe 1 includes an outer cylinder 10 and a plunger 30 inserted into the outer cylinder 10 so as to be capable of being pushed and pulled. The central axes of the outer cylinder 10 and the plunger 30 coincide with the central axis 1 a of the syringe 1.

  The syringe 1 is a syringe that can be connected to the male connector 6 (see FIG. 6B). The male connector 6 includes a male luer 61 and an outer cylindrical portion 62 that surrounds the male luer 61 and has an internal thread 65 formed on the inner peripheral surface thereof facing the male luer 61.

  As shown in FIGS. 1 to 2B, a cylindrical (preferably cylindrical) main body 11 is provided. A mouth portion 20 is formed at one end of the main body 11, and a finger hooking flange 12 is formed integrally with the main body 11 at the other end of the main body 11. For convenience of the following description, the direction of the central axis 1a of the syringe 1 is referred to as the “front-rear” direction, and with respect to a certain position, the distal end side of the mouth portion 20 is referred to as the “front end side”, The opposite side (the finger contact part 31 side described later) is referred to as a “base end side”. Furthermore, a direction orthogonal to the central axis 1a is referred to as a “radial direction”, and a direction rotating around the central axis 1a is referred to as a “circumferential direction”.

  The mouth 20 will be described with reference to FIGS. 3 is a partially enlarged view of FIG. 2A, and FIG. 4 is a partially enlarged view of FIG. 2B.

  The mouth portion 20 includes a cylindrical body 21 communicating with the lumen 111 of the main body 11, and a male screw 22 formed on the outer surface of the cylindrical body 21. The tubular body 21 is formed with a flow path 23 penetrating the tubular body 21 along the longitudinal direction thereof. The cylindrical body 21 includes a liquid contact portion 21c, a fracture portion 21b, and an insertion portion 21a from the tip. The insertion portion 21 a is disposed closer to the main body 11 than the male screw 22. The breaking portion 21 b is arranged at a position farther from the main body 11 than the male screw 22. The liquid contact part 21c is arranged at a position farther from the main body 11 than the fracture part 21b. In other words, the cylindrical body 21 includes the insertion portion 21a disposed on the proximal side relative to the male screw 22, the breaking portion 21b disposed on the distal end side relative to the male screw 22, and the distal end side relative to the breaking portion 21b. And a wetted part 21c arranged.

  A V-shaped groove is provided along the circumferential direction of the cylindrical body 21 in a region adjacent to the male screw 22 on the distal end side of the external thread 22 on the outer surface of the cylindrical body 21. The region is a thin region in which the cylindrical wall of the cylindrical body 22 is thinner than the insertion portion 21a and the liquid contact portion 21c. In this thin region, the thickness of the tube wall at the center in the front-rear direction is the thinnest, and the portion where the thickness of the tube wall is the thinnest is the fracture portion 21b. When the operation of separating the wetted part 21c from the cylindrical body 21 is performed, the fractured part 21b is broken, and the wetted part 21c becomes a cylindrical body as shown in FIGS. 5A and 5B. Detach from 21. A portion of the tubular body 21 that is proximal to the cutting portion 21b (a portion that is left in the tubular body 21 in a state where the liquid contact portion 21c is separated from the tubular body 21) includes a male screw 22 and an insertion portion 21a. It will be in the state which can function as the female connector 5.

  The shape of the cut surface of the thin region that is visible when the syringe 1 is cut along the plane including the central axis 1a is not limited to the V shape, and may be an inverted trapezoidal shape, an I shape, or the like. From the viewpoint of improving ease, a V-shape is preferable.

  Although there is no restriction | limiting in particular about the outer diameter and internal diameter of the liquid-contact part 21c, From an easy viewpoint of manufacture, it is preferable that both the external diameter and internal diameter of the liquid-contact part 21c are constant along the longitudinal direction of the liquid-contact part 21c.

  The inner diameter of the base end side portion of the cylindrical body 21 (the portion closer to the main body 11 than the cutting portion 21b of the cylindrical body 21) is the inner diameter of the male connector 6 (see FIG. 6B) described later. There is no particular limitation as long as it can receive the male luer 61 and the female connector 5 (see FIG. 5B) including the insertion portion 21a and the male screw 22 and the male connector 6 can be reliably connected. From the viewpoint of enabling connection excellent in liquid tightness and connection strength, in a state where the female connector 5 and the male connector 6 are connected, the proximal end portion of the tubular body 21 is more than the cutting portion 21b. The inner diameter at the same position in the axial direction as the male luer 61 is preferably based on ISO 80369-3. For example, the inner peripheral surface of the cylindrical body 21 at the same position in the axial direction as the male luer 61 at the base end side of the cutting portion 21b is a first female taper surface (of the truncated cone having a smaller inner diameter as the main body 11 is approached). Side surface) 211 may be included, and the first female taper surface 211 may be a 6 / 100th taper surface defined in ISO594-1. In this case, the taper angle of the first female taper surface 211 is the same as that of the first male taper surface 612 of the male luer 61 studied as ISO 80369-3.

  The inner peripheral surface of the proximal end portion of the tubular body 21 relative to the cutting portion 21b (the portion of the tubular body 21 closer to the main body 11 than the cutting portion 21b) is adjacent to the first female taper surface 211. In addition, it is preferable that the taper angle is larger than that of the first female taper surface 211, for example, the second female taper surface 212 conforming to ISO 80369-3 is included. In other words, the inner peripheral surface of the proximal end portion of the tubular body 21 relative to the cutting portion 21b is the distal end side of the tubular body 21 relative to the cutting end 21b of the tubular body 21 (of the tubular body 21). It is preferable that the first female taper surface 211 and the second female taper surface 212 are included in this order from an end far from the main body 11 of the base end side portion of the cutting portion 21b. In such a form, it is possible to prevent a medical device other than the nutritional system, for example, a venous medical device from being erroneously connected to the female connector 5.

  As shown in FIGS. 2A and 2B, the plunger 30 is a rod-like object integrally formed with a finger contact portion 31 whose diameter is increased in a flange shape at the rear end thereof. A gasket 4 is attached to the tip of the plunger 30. The tip of the plunger 30 is inserted into the opening on the flange 12 side of the outer cylinder 10. The gasket 4 slides in the direction of the central axis 1 a on the inner peripheral surface of the main body 11 while forming a liquid-tight seal with the inner peripheral surface of the main body 11 of the outer cylinder 10.

  The material of the outer cylinder 10 is not particularly limited. For example, a resin having high transparency and high chemical resistance can be used. For example, cyclic polyolefin, polycarbonate, polyethylene terephthalate, polypropylene and the like are preferable.

  The material of the plunger 30 is not particularly limited, but for example, resins such as cyclic polyolefin, polycarbonate, polyethylene terephthalate, polypropylene, and polyacetal are preferable.

  The outer cylinder 10 and the plunger 30 can be integrally formed by injection molding or the like using the above resins, respectively.

  The material of the gasket 4 is not particularly limited, and for example, butyl rubber, isoprene rubber, styrene thermoplastic elastomer, and the like are preferable.

  An example of how to use the syringe 1 of the present embodiment configured as described above will be described below.

  In a wide-mouthed container, a liquid enteral nutrient and an agar solution are mixed, and these are mixed. The semi-solid enteral nutrient is filled in the syringe 1, and the syringe 1 is stored in a refrigerator. . When the syringe 1 is filled with the semi-solid enteral nutrient, only the liquid contact portion 21c is immersed in the enteral nutrient, and the enteral nutrient is placed on the surface of the male screw 22 and the outer peripheral surface of the insertion portion 21a. Be careful not to adhere.

  After filling the syringe 1 with the enteral nutrient, the enteral nutrient adhering to the outer peripheral surface of the liquid contact part 21c is wiped off with gauze or the like before storage. When the syringe 1 is stored in the refrigerator, a cap (not shown) that covers at least the liquid contact portion 21 c may be attached to the mouth portion 20 of the syringe 1. This cap is preferably in a form in which the rupture portion 21 b can be broken and the liquid contact portion 21 c can be broken off from the tubular body 21 with the cap attached to the mouth portion 20.

  Next, the enteral nutrient is returned to room temperature, and for example, the wetted part 21c is sandwiched between gauze and the wetted part 21c is folded from the cylindrical body 21. When the capping part 21b can be broken while the cap covering the liquid contact part 21c is attached to the mouth part 20, and the liquid contact part 21c can be folded from the cylindrical body 21, the cap is attached to the mouth part 20. The wetted part 21c may be broken off from the cylindrical body 21 in the mounted state. FIG. 5A shows a state in which the liquid contact part 21c is being separated from the insertion part 21a by the breaking part 21b in the syringe 1, and FIG. 5B shows a state in which the liquid contact part 21c is separated from the insertion part 21a. . The female connector 5 comprising the insertion portion 21a and the male screw 22 which is the remaining portion of the cylindrical body 21 remaining by folding the wetted portion 21c from the cylindrical body 21 is a female that has been studied as ISO 80369-3. Since it is a connector, it can be connected to the male connector 6 (see FIG. 6A and FIG. 6B) considered as ISO 80369-3.

  Next, the syringe 1 from which the liquid contact part 21c is cut is connected to the male connector 6 (see FIGS. 6A and 6B) of the PEG catheter 8 placed in the patient. 6A is a partial front view of the PEG catheter 8 that can be connected to the syringe 1, and FIG. 6B is a 6B-6B cross-sectional view of the PEG catheter 8 shown in FIG. 6A. The PEG catheter 8 is replaced approximately every 1 to 6 months after being placed in the patient.

  As shown in FIGS. 6A and 6B, the PEG catheter 8 includes a transfer tube 7 and a male connector 6 connected to one end of the transfer tube 7. The male connector 6 includes a cylindrical male luer 61 and an outer cylindrical portion 62 surrounding the male luer 61 at one end, and a cylindrical base end 63 at the other end. A flow path 64 along the central axis 6 a of the male connector 6 passes through the male connector 6 from the male luer 61 to the base end portion 63.

  The outer peripheral surface 12 of the male luer 61 includes a first male tapered surface (side surface of the truncated cone) 612 that decreases in outer diameter as it approaches the tip from the root of the male luer 61, and a second male tapered surface 613 adjacent to the first male tapered surface. Including. The second male tapered surface 613 is the outer surface of the tip portion 611 of the male luer 61 and has a larger taper angle than the first male tapered surface. A connecting portion 66 that connects the male luer 61 and the outer cylindrical portion 62 protrudes outward from the root of the male luer 61 along the radial direction. An outer cylindrical portion 62 having a cylindrical shape is provided on the outer peripheral end of the upper surface of the connecting portion 66 (the surface on the male luer 61 side). The outer cylinder portion 62 surrounds the male luer 61. A female screw 65 is formed on the inner peripheral surface (surface facing the male luer 61) of the outer cylindrical portion 62.

  The male luer 61 and the female screw 65 surrounding the male luer 61 comply with the male connector 910 (FIGS. 8 and 8B) of ISO 80369-3 described above. Therefore, the male connector 6 can be connected to a female connector based on ISO80369-3.

  As shown in FIG. 7, the female connector 5 of the syringe 1 and the male connector 6 of the PEG catheter 8 insert the male luer 61 into the insertion portion 21 a and screw the female screw 65 and the male screw 22 together. Connected. In a state where the female connector 5 is connected to the male connector 6, both the first male tapered surface 612 and the first female tapered surface 211 are in liquid-tight surface contact.

  The transfer tube 7 is inserted into a flow path 64 that penetrates the base end portion 63. The transfer tube 7 is made of a soft material having flexibility such as silicone rubber and urethane, and the male connector 6 is preferably, for example, cyclic polyolefin, polycarbonate, polyethylene terephthalate, or polypropylene.

  As long as the male connector 6 is connected to one end of the transfer tube 7, the configuration of the other PEG catheter 8 is not particularly limited. Although not shown in FIGS. 6A and 6B, the PEG catheter 8 further includes components provided in a conventionally known PEG catheter such as a balloon and a bumper provided at the other end of the transfer tube 7. It may be.

  In the above-described example of the method of using the syringe 1 according to the present embodiment, the syringe 1 is stored for a certain period after filling the syringe 1 with the enteral nutrient, but the syringe 1 according to the present embodiment is liquid. Immediately after filling, the wetted part 21c may be broken off from the cylindrical body 21 and the female connector 5 and the male connector 6 may be connected. Further, the enteral nutrient filled in the syringe 1 of the present embodiment may be a commercially available semi-solid enteral nutrient.

  In the above description, the female connector 5 including the insertion portion 21a and the male connector 22 is connected to the male connector 6 disposed at the upstream end of the PEG catheter. However, the female connector 5 is connected to the PEG catheter and is upstream. Upstream of any tube through which enteral nutrients flow, such as a flexible tube (not shown) with a male connector 6 at the end, a nasal catheter (not shown) with a male connector 6 at the upstream end It can be connected to a male connector provided at the end.

  In the present invention, since it is possible to collect the liquid without attaching enteral nutrient to the female connector consisting of the male screw and the insertion portion, while suppressing the attachment of enteral nutrient to the female screw of the male connector, A male connector and a syringe can be connected. Therefore, the syringe of the present invention can hygienically supply enteral nutrients to patients in enteral nutrition therapy.

DESCRIPTION OF SYMBOLS 1 Syringe 10 Outer cylinder 11 Main body 20 Mouth part 21 Tubular body 21a Insertion part 21b Breaking part 21c Liquid contact part 211 1st female taper surface 212 2nd female taper surface 22 Male screw 30 Plunger 4 Gasket 5 Female connector 6 Male connector 61 Male connector 612 1st male taper surface 613 2nd male taper surface 62 Outer cylinder part 63 Base end part 65 Female thread 8 PEG catheter

Claims (3)

A syringe that includes an outer cylinder that is used to collect enteral nutrients and has a cylindrical main body and a mouth provided at one end of the main body,
The mouth includes a cylindrical body communicating with the lumen of the main body, and a male screw formed on the outer surface of the cylindrical body,
The cylindrical body is
An insertion portion disposed on the base end side of the cylindrical body from the male screw;
A fractured portion that is disposed closer to the distal end side of the cylindrical body than the male screw and extends in the circumferential direction of the cylindrical body;
A wetted part that is disposed closer to the distal end side of the cylindrical body than the fractured part and can be separated from the cylindrical body by the fracture of the cylindrical body at the fractured part,
The inner peripheral surface of the base end side portion of the tubular body relative to the rupture portion includes a female taper surface whose inner diameter becomes smaller as it approaches the main body,
A syringe capable of receiving a male luer of a male connector in the proximal end portion in a state where the liquid contact portion is separated from the cylindrical body. The syringe according to claim 1 , wherein the insertion portion and the male screw comply with ISO80369-3. Use of the syringe according to claim 1 or 2 as a storage container for enteral nutrients.

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