JP2023087067A - Stylet apparatus - Google Patents

Abstract

To provide a stylet apparatus that can be connected to a male lure of a catheter connector, and can be manufactured easily because of its simple structure.SOLUTION: A stylet connector 10 includes a first connector 20 and a second connector 30. A flow channel 11 passes through the stylet connector so that the first connector and the second connector are communicated with each other. The first connector includes a female tapered surface 22. A wire holding part 40 is provided in a flow channel on a second connector side for the first connector. A guide wire 50 is inserted into a lumen of the wire holding part and is fixed to the stylet connector through an adhesive 48 put in the lumen. The guide wire is derived from the first connector through the flow channel. Separately from the flow channel, a through-hole 45 passing through the stylet connector is provided so as to communicate the wire holding part with the outside of the stylet connector.SELECTED DRAWING: Figure 1B

Description

The present invention relates to a stylet device that is used by being inserted into a catheter tube.

BACKGROUND ART Enteral nutrition is known as a method of administering liquids containing nutritional supplements, drugs, etc. to patients who cannot take food orally. In enteral nutrition, liquids such as nutritional supplements and drugs are administered to a patient through a catheter tube inserted from the patient's nasal cavity to the stomach or small intestine. Because the catheter tube is small and flexible, it bends or bends easily. It can be difficult to navigate such a catheter tube through the nasal cavity to the desired location. In this case, a metal guide wire (sometimes called a "stylet") having relatively high rigidity compared to the catheter tube is inserted into the catheter tube.

A catheter connector is provided at the proximal end of the catheter tube (the upstream end in the flow direction of the liquid). The proximal end of the guidewire is provided with a stylet connector connectable to a catheter connector. Insert the guidewire into the catheter tube and connect the stylet connector to the catheter connector. The stiffened catheter tube in this state is inserted into the patient.

Whether or not the distal end of the catheter tube has reached the desired position can be confirmed, for example, by sucking gastric juice or injecting air through the catheter tube. Aspiration of gastric juice or injection of air is performed, for example, by connecting a syringe to a stylet connector. Once it is confirmed that the tip of the catheter tube has reached the desired location, the stylet connector is separated from the catheter connector and the guidewire is withdrawn from the catheter tube. A catheter tube is left in the patient. After that, a connector provided at the downstream end of an enteral feeding tube (sometimes called an “enteral feeding set”) is connected to the catheter connector. The liquid stored in the container is administered to the patient through an enteral feeding tube and a catheter tube in that order.

As a catheter connector, standardization of a male connector having a male luer and a female thread surrounding the male luer as international standard ISO 80369-3 is under consideration (see Patent Documents 1 and 2, for example). In this case, the stylet connector must have a female luer into which the male luer of this male connector can be fitted. A guidewire must be led out of this female luer.

Patent Literature 3 describes a stylet device in which a guidewire leads out of a hollow entry hole in a stylet connector. A hollow cylindrical member is fitted in the inlet hole with an interference fit. The proximal end of the guidewire is sandwiched between the inner peripheral surface of the entry hole and the hollow cylindrical member.

JP 2014-100347 A JP 2015-119837 A Japanese Patent Publication No. 11-500044

In the stylet device of Patent Literature 3, a hollow cylindrical member that is separate from the stylet connector is used in order to attach the guide wire to the stylet connector. Therefore, the number of parts constituting the stylet device increases. This complicates the construction of the stylet device.

In addition, since it is necessary to fit the inner peripheral surface of the inlet hole of the stylet connector and the hollow cylindrical member by interference fit, it is necessary to strictly control the dimensional accuracy of these components. It is troublesome to fit the hollow cylindrical member into the inlet hole with interference fit while the guide wire is sandwiched between the inner peripheral surface of the inlet hole and the hollow cylindrical member. These make the stylet device difficult to manufacture.

SUMMARY OF THE INVENTION It is a first object of the present invention to provide a stylet device with a stylet connector connectable to a male luer of a catheter connector. A second object of the present invention is to provide a stylet device that is structurally simple and easy to manufacture.

The stylet device of the present invention comprises a bendable guide wire and a stylet connector provided at the proximal end of the guide wire. The stylet connector includes a first connector, a second connector, and a flow path passing through the stylet connector along its central axis such that the first connector and the second connector communicate with each other. The first connector has a female tapered surface whose inner diameter increases toward the tip of the first connector. A wire holding portion having a lumen opening toward the first connector is provided in the flow path on the second connector side with respect to the first connector. The proximal end of the guide wire is inserted into the lumen of the wire holding portion and fixed to the stylet connector via an adhesive filling the lumen. The guide wire is led out from the first connector through the channel. A through hole penetrating the stylet connector is provided separately from the flow path so as to communicate the inner cavity of the wire holding portion with the outside of the stylet connector.

According to the invention, the first connector of the stylet connector is provided with a female tapered surface. Thus, the stylet connector of the stylet device of the present invention can be connected to the male luer of the catheter connector.

The proximal end of the guidewire is fixed to the stylet connector via an adhesive filled in the wire holding portion. Therefore, the construction of the stylet device of the present invention is simple.

A through hole leading to the wire holding portion passes through the stylet connector separately from the flow channel. Via this through-hole, uncured adhesive can be injected into the lumen of the wire holder. Accordingly, the stylet device of the present invention can be easily manufactured.

1 is a perspective view of a stylet device according to one embodiment of the present invention; FIG. 1B is a cross-sectional view of a stylet device in accordance with one embodiment of the present invention; FIG. FIG. 2 is a cross-sectional view showing one step in manufacturing a stylet device according to one embodiment of the present invention. FIG. 3 is a cross-sectional view illustrating the next step in manufacturing a stylet device in accordance with an embodiment of the present invention; FIG. 4A is a perspective view showing a state in which a guidewire of a stylet device according to one embodiment of the present invention is inserted into a nasal catheter; FIG. 4B is a cross-sectional view of FIG. 4A. FIG. 5A is a perspective view showing a state in which the stylet connector of the stylet device according to one embodiment of the present invention is connected to the catheter connector of the nasal catheter; FIG. 5B is a cross-sectional view of FIG. 5A.

In the above-described stylet device of the present invention, the through hole may be inclined with respect to the central axis of the stylet connector so as to deviate toward the first connector as it separates from the wire holding portion. good. According to this aspect, when the stylet connector is held with the first connector facing upward, the opening of the through hole faces obliquely upward. In this state, it is easy to inject the uncured adhesive into the wire holding portion through the through hole. In addition, after injection, the uncured adhesive does not leak from the opening of the through hole. Accordingly, the above aspects are advantageous in facilitating manufacture of the stylet device.

The edge of the opening of the through-hole may be positioned substantially at the same position as the edge of the opening of the wire holding portion in the central axis direction of the stylet connector. According to this aspect, when the stylet connector is held with the first connector facing upward, the edge of the opening of the through-hole and the edge of the opening of the wire holding portion are at substantially the same height. Therefore, the uncured adhesive injected into the through-hole and the wire holding portion is less likely to leak out from either the through-hole or the wire holding portion. This is advantageous in facilitating manufacturing of the stylet device.

An inner peripheral surface of the through hole may be provided with a female taper surface whose inner diameter increases with increasing distance from the wire holding portion. According to this aspect, when the nozzle for injecting uncured adhesive is inserted into the through hole, a liquid-tight seal is formed between the female taper surface and the nozzle. This seal is advantageous in preventing leakage of uncured adhesive from between the inner peripheral surface of the through hole and the nozzle.

The adhesive may be continuously filled from the inner cavity of the wire holding portion to the through hole. According to this aspect, communication between the flow channel in the stylet connector and the outside world through the through-hole is reliably blocked by the adhesive.

The surface of the adhesive in the wire holding portion may be substantially at the same position in the central axis direction of the stylet connector as the surface of the adhesive in the through hole.

The wire holding portion may be arranged eccentrically with respect to the central axis of the stylet connector. Such an aspect is advantageous in securing a sufficient cross-sectional area of the flow channel at the position where the wire holding portion is provided.

The lumen of the wire retainer may have an inner dimension greater than the outer diameter of the guidewire. Such an aspect firstly facilitates control of the amount of uncured adhesive injected, secondly allows a sufficient amount of adhesive to secure the guidewire to the stylet connector, and thirdly. , facilitates positioning the guidewire substantially coaxially with the central axis of the stylet connector.

The guidewire may be arranged substantially coaxially with the central axis of the stylet connector. According to this aspect, when the stylet connector is connected to the catheter connector, the amount of eccentricity of the guide wire with respect to the catheter tube is reduced. This is advantageous in facilitating the work of inserting the catheter tube into the patient.

The second connector may have a male tapered surface whose outer diameter decreases toward the tip of the second connector. According to this aspect, it is possible to connect a common female luer to both the male luer of the catheter connector to which the first connector is connectable and the second connector.

The second connector may be compatible with a male connector to which the first connector is connectable. According to this aspect, the common female connector can be connected to both the male connector of the catheter connector to which the first connector can be connected and the second connector.

The present invention will be described in detail below while showing preferred embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. Each figure referred to in the following description simply shows main members constituting the embodiment of the present invention for convenience of explanation. Accordingly, any elements not shown in the drawings may be added or any elements shown in the drawings may be changed or omitted without departing from the scope of the invention. In different drawings, the same parts are provided with the same reference numerals. Duplicate descriptions of such members are omitted, and the descriptions of the preceding drawings should be appropriately considered.

FIG. 1A is a perspective view of a stylet device 1 according to one embodiment of the invention. FIG. 1B is a cross-sectional view of the stylet device 1. FIG. The stylet device 1 includes a stylet connector 10 and a guidewire 50. As shown in FIG. In FIG. 1B, the dashed line 10a is the central axis of the stylet connector 10. In FIG. The cross section of FIG. 1B is along the central axis 10a and the through hole 45 (details will be described later). For the convenience of the following description, the direction of a straight line orthogonal to the central axis 10a will be referred to as "radial direction" or "diameter direction." "Outer" in the radial direction means the side away from the central axis 10a, and "inner" in the radial direction means the side closer to the central axis 10a.

The stylet connector 10 has a first connector 20 at one end (first end) in the direction of the central axis 10a and a second connector 30 at the other end (second end). As shown in FIG. 1B, the first connector 20 and the second connector 30 are arranged coaxially with the central axis 10a and connected via a hollow connecting tube 12. As shown in FIG. A flow path 11 passes through the stylet connector 10 along the central axis 10a so as to allow the first connector 20 and the second connector 30 to communicate with each other.

The first connector 20 has a hollow, substantially cylindrical shape. The inner peripheral surface of the first connector 20 has a female tapered surface (first female tapered surface) 22 whose inner diameter increases toward the tip of the first connector 20 . The first connector 20 is a female luer with a female tapered surface 22 . The female tapered surface 22 is fitted (so-called tapered) in surface contact with a male tapered surface 132 (see FIGS. 4A and 4B described later) of a male luer 131 provided on the catheter connector 110 of the nasal catheter 100 to which the stylet device 1 is fitted. It is preferable that the diameter and taper angle match the male taper surface 132 so that the male taper surface 132 fits. The first connector 20 (particularly its female tapered surface 22) may comply with the international standard ISO 80369-3 for nutritional medical devices.

The second connector 30 has a male luer 31 having a hollow, substantially cylindrical shape. The outer peripheral surface of the male luer 31 has a male taper surface 32 whose outer diameter decreases as it approaches the tip of the male luer 31 . The second connector 30 further has a substantially cylindrical outer cylinder 35 radially spaced apart from and surrounding the male luer 31 . A female screw 36 is provided on the inner peripheral surface of the outer cylinder 35 . The second connector 30 is preferably compatible with the male connector 130 (see FIGS. 4A and 4B described below) of the catheter connector 110 provided on the nasal catheter 100 to which the stylet device 1 is compatible. The second connector 30 (particularly its male tapered surface 32 and internal threads 36) may comply with international standard ISO 80369-3.

A wire holding portion 40 is provided in the flow path 11 of the connecting tube 12 that connects the first connector 20 and the second connector 30 . The wire holding part 40 has a bottomed, substantially hollow cylindrical shape (or a substantially container shape, or a substantially box shape) as a whole. The longitudinal direction (major axis) of the wire holding portion 40 is parallel to the central axis 10a. A lumen 41 of the wire holding portion 40 opens toward the first connector 20 . The lumen 41 communicates with the channel 11 through the opening of the wire holding portion 40 . The wire holding portion 40 protrudes radially inward from the inner peripheral surface of the flow path 11 . The wire holding portion 40 is eccentric radially outward with respect to the central axis 10a. This is advantageous in securing a sufficient cross-sectional area of the flow path 11 at the position where the wire holding portion 40 is provided.

A through-hole 45 penetrates the stylet connector 10 so as to allow communication between the lumen 41 of the wire holding portion 40 and the outside of the stylet connector 10 . The through-hole 45 extends outward from the deepest portion of the lumen 41 of the wire holding portion 40 (that is, the end of the lumen 41 on the side of the second connector 30 ) or its vicinity to the outer peripheral surface of the stylet connector 10 . . The through hole 45 is inclined with respect to the central axis 10a (that is, neither parallel nor perpendicular to the central axis 10a). More specifically, the through-hole 45 is inclined with respect to the central axis 10a so as to deviate toward the first connector 20 as it separates from the wire holding portion 40 . An end edge 47 of the opening of the through hole 45 on the side opposite to the wire holding portion 40 is located in the direction of the central axis 10a with respect to the connection portion 44 (see FIG. 2) between the through hole 45 and the wire holding portion 40. It is located on the 20th side. Further, the edge 47 of the opening of the through hole 45 and the edge 42 of the opening of the wire holding portion 40 are at substantially the same position in the direction of the central axis 10a. The inner peripheral surface of the through hole 45 has a female taper surface (second female taper surface) 46 near the end edge 47 whose inner diameter increases with distance from the wire holding portion 40 .

A guide wire 50 is inserted into the channel 11 and the lumen 41 of the wire holding portion 40 . The proximal end (or the proximal end of the guidewire 50; the upper end of the guidewire 50 in FIG. 1B) of the guidewire 50 reaches the deepest part of the lumen 41 of the wire holding part 40 (that is, the bottom of the wire holding part 40). The inner dimension of the lumen 41 of the wire holding portion 40 (in particular, the inner dimension of the lumen 41 along the radial direction) is larger than the outer diameter of the guidewire 50 . The guide wire 50 is disposed within the lumen 41 of the wire holding portion 40 eccentrically with respect to the axis of the wire holding portion 40 so as to be close to (preferably coaxial with) the central axis 10a. It is A proximal end of the guide wire 50 is fixed to the stylet connector 10 via an adhesive 48 filled in the lumen 41 of the wire holding portion 40 . A guide wire 50 is led out from the first connector 20 through the channel 11 .

The adhesive 48 is continuously filled from the lumen 41 of the wire holding portion 40 to the through hole 45 . A surface 48 a of the adhesive 48 in the wire holding portion 40 is positioned on the second connector 30 side in the direction of the central axis 10 a with respect to the edge 42 of the opening of the wire holding portion 40 . Further, the surface 48a of the adhesive 48 inside the wire holding portion 40 is at substantially the same position as the surface 48b of the adhesive 48 inside the through hole 45 in the direction of the central axis 10a.

Stylet connector 10 is preferably made of a rigid material. Moreover, the material of the stylet connector 10 preferably has transparency or translucency. Specifically, resin materials such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, and rigid polyvinyl chloride can be used. The stylet connector 10 can be manufactured integrally as a whole as a single part by injection molding or the like using these resin materials.

The guide wire 50 is a long, thin cord-like object having appropriate flexibility (or softness) so that it can be bent and deformed by an external force. The guidewire 50 is inserted into the catheter tube 150 of the nasal catheter 100 in order to improve the stiffness (elasticity) of the catheter tube 150 and prevent kinking (see FIGS. 4B and 5B described below). The outer diameter of guidewire 50 is smaller than the inner diameter of catheter tube 150 . The configuration of the guidewire 50 is not limited and may be the same as that of known guidewires used in enteral feeding catheters. For example, the guide wire 50 may be a stranded wire in which strands are twisted together. The material of the strands is not limited, but may be metal such as stainless steel, or relatively high-rigidity (high-elasticity) resin such as nylon or polyester. Furthermore, the guide wire 50 may be configured by combining metal and resin.

A method for manufacturing the stylet device 1 will be described.

First, as shown in FIG. 2, the stylet connector 10 is held by a jig or the like (not shown) so that the first connector 20 faces upward and the central axis 10a is parallel to the vertical direction. . A guide wire 50 is inserted through the first connector 20 and into the wire retainer 40 . The proximal end of the guide wire 50 (the lower end of the guide wire 50 in FIG. 2) abuts the bottom of the wire holding portion 40 in the vertical direction. With the guide wire 50 parallel to the central axis 10a and the guide wire 50 being as close to the central axis 10a as possible within the lumen 41 of the wire holding part 40 (or coaxial with the central axis 10a), the guide The wire 50 is held by a jig or the like (not shown).

Next, as shown in FIG. 3, the nozzle 70 is inserted into the through-hole 45 . A proximal end (not shown) of the nozzle 70 is connected to, for example, the tip of a syringe (not shown) containing the uncured adhesive 48 . Since the opening of the through-hole 45 faces obliquely upward, the nozzle 70 can be easily inserted. An uncured adhesive 48 is injected into the through hole 45 and the lumen 41 of the wire holding portion 40 through the nozzle 70 . The outer peripheral surface of the tip of the nozzle 70 is liquid-tightly fitted to the female taper surface 46 of the inner peripheral surface of the through hole 45 . Therefore, the adhesive 48 does not leak out from between the inner peripheral surface of the through hole 45 and the nozzle 70 . Although the amount of the adhesive 48 to be injected is not limited, for example, the upper surface (liquid surface) 48a of the adhesive 48 in the wire holding portion 40 is equal to or slightly smaller than the edge 42 of the opening of the wire holding portion 40. It may be adjusted to reach a lower position. In this case, the upper surface 48 a of the adhesive 48 is positioned higher than the tip of the nozzle 70 . If the stylet connector 10 is transparent, the liquid surface 48 a of the adhesive 48 can be seen through the stylet connector 10 . Adhesive 48 may be any adhesive capable of securing guidewire 50 to stylet connector 10 . The adhesive 48 is preferably liquid with a relatively low viscosity. Specifically, an epoxy resin-based adhesive or an ultraviolet curing adhesive can be used. The fact that the stylet connector 10 is translucent is advantageous for curing the ultraviolet curable adhesive.

After injecting the adhesive 48 , the nozzle 70 is removed from the through hole 45 . When the nozzle 70 is pulled out, the upper surface 48a of the adhesive 48 in the wire holding portion 40 and the upper surface 48b of the adhesive 48 in the through-hole 45 are lowered slightly so that they are approximately the same height. and the upper surface 48b rises slightly (see FIG. 1B). The edge 42 of the opening of the wire holding portion 40 and the edge 47 of the opening of the through hole 45 are at substantially the same height. Therefore, the adhesive 48 does not leak from the wire holding portion 40 and the through hole 45 even if the heights of the upper surfaces 48a and 48b change in this way.

After that, the adhesive 48 is cured. A stylet device 1 (see FIGS. 1A and 1B) is thus obtained.

The stylet device 1 is inserted into the enteral feeding catheter prior to inserting the enteral feeding catheter into the patient. A method of using the stylet device 1 will be described by taking as an example a case where the enteral feeding catheter is a nasal catheter.

FIG. 4A is a perspective view showing a state where the guide wire 50 of the stylet device 1 is inserted into the nasal catheter 100. FIG. FIG. 4B is a cross-sectional view thereof. The nasal catheter 100 includes a flexible catheter tube (hereinafter simply referred to as “tube”) 150 and a catheter connector 110 provided at the base end (proximal end) of the tube 150 .

As shown in FIG. 4B, the catheter connector 110 has a male connector 130 at one end and a connecting tube 120 at the other end. A flow path 111 penetrates the catheter connector 110 so that the male connector 130 and the connection tube 120 are in communication.

The male connector 130 includes a hollow male luer 131 having a substantially cylindrical shape, a substantially cylindrical outer cylinder 135 radially spaced from the male luer 131 and surrounding the male luer 131 , and a female connector provided on the inner peripheral surface of the outer cylinder 135 . a screw 136; The flow path 111 penetrates the male luer 131 along its longitudinal direction. The outer peripheral surface of the male luer 131 has a male tapered surface 132 whose outer diameter decreases as it approaches the tip of the male luer 131 . The male connector 130 can be connected to and separated from a female connector (not shown) provided at the downstream end of an enteral feeding tube (enteral feeding set) through which a liquid to be administered to a patient flows. The male connector 130 and female connector may comply with the international standard ISO80369-3. Note that the male connector 130 may not have the outer cylinder 135 and the female screw 136 .

The connection cylinder 120 also has a hollow, substantially cylindrical shape as a whole. The connection tube 120 is arranged coaxially with the male luer 131 . A tube 150 is inserted into the connection tube 120 . The tube 150 is fixed to the inner peripheral surface of the connecting tube 120 via an adhesive (not shown). Male luer 131 and tube 150 are in communication. A pair of grip pieces 125 protrude radially outward from the outer peripheral surface of the connection tube 120 to facilitate gripping of the catheter connector 110 .

4A and 4B, the stylet connector 10 is connected to the catheter connector 110. FIG.

5A is a perspective view showing a state in which the stylet connector 10 of the stylet device 1 is connected to the catheter connector 110 of the nasal catheter 100. FIG. FIG. 5B is a cross-sectional view thereof. Male luer 131 of catheter connector 110 is inserted into first connector (female luer) 20 of stylet connector 10 . The first connector 20 is inserted into the gap between the male luer 131 and the outer cylinder 135 . The female taper surface 22 of the first connector 20 and the male taper surface 132 of the male luer 131 have the same diameter and taper angle. Therefore, the female taper surface 22 and the male taper surface 132 are in surface contact and are liquid-tightly fitted (so-called taper fitting). Such a connection between first connector 20 and male luer 131 is commonly referred to as a "slip connection". The flow path 11 of the stylet connector 10, the flow path 111 of the catheter connector 110, and the tube 150 communicate in order. A guide wire 50 is inserted into the channel 111 and the tube 150 . Although illustration is omitted, the tip (distal end) of the guide wire 50 reaches the tip (distal end) of the tube 150 or its vicinity.

With the stylet connector 10 connected to the catheter connector 110 as shown in FIGS. 5A and 5B, the tip (not shown) of the tube 150 is inserted into the nasal cavity of the patient. The rigidity (elasticity) of the tube 150 is increased by inserting the guide wire 50 therein. This is advantageous in allowing the tip of tube 150 to reach a desired location (eg, stomach or small intestine).

Whether or not the tip of the tube 150 has reached the desired position can be confirmed, for example, by sucking gastric juice or injecting air through the tube 150 . Aspiration of gastric juice or injection of air can be performed by connecting, for example, a syringe to the second connector 30 of the stylet connector 10 (particularly its male luer 31). When it is confirmed that the tip of tube 150 has reached the desired position, stylet connector 10 is separated from catheter connector 110 and guidewire 50 is withdrawn from tube 150 . Stylet device 1 is separated from nasal catheter 100 . Nasal catheter 100 is left in the patient. A female connector provided at the downstream end of the enteral feeding tube is connected to the male connector 130 . Liquids are administered to the patient via an enteral feeding tube and nasal catheter 100 .

As described above, in the stylet device 1 of the present embodiment, the proximal end of the guide wire 50 is fixed to the wire holding portion 40 provided in the flow path 11 between the first connector 20 and the second connector 30. be. The first connector 20 is a female luer with a female tapered surface 22 . A guide wire 50 is led out from the first connector 20 . Since the wire holding portion 40 is located at the back (second connector 30 side) of the first connector 20, the wire holding portion 40 is positioned between the first connector 20 (female taper surface 22) and the male luer 131 (male taper surface 22) of the catheter connector 110. 132) (see FIG. 5B). The stylet connector 10 of the stylet device 1 can be connected to a catheter connector 110 having a male connector 130 conforming to international standard ISO80369-3.

The proximal end of guidewire 50 is secured to stylet connector 10 via adhesive 48 (see FIG. 1B). Therefore, the configuration of the stylet device 1 is simple. The stylet device of Patent Document 3 mentioned above uses a hollow cylindrical member for attaching the guide wire to the stylet connector. This embodiment does not require a component separate from the stylet connector, such as a hollow cylindrical member.

The uncured adhesive 48 is injected into the lumen 41 of the wire holding portion 40 through a through hole 45 provided separately from the flow path 11 (see FIG. 3). Unlike the present embodiment, a method of inserting the nozzle 70 into the first connector 20 in the state of FIG. be done. However, this method has the following problems. First, the guide wire 50 within the first connector 20 makes it difficult to access the tip of the nozzle 70 to the wire holder 40 . Second, in the process of bringing the tip of the nozzle 70 closer to the wire holding part 40, or in the process of pulling out the nozzle 70 from the first connector 20 after injecting the adhesive into the wire holding part 40, the tip of the nozzle 70 is pushed into the female taper. Accidental touching of surface 22 may result in adhesive being deposited on female taper surface 22 . The adhesive adhering to the female taper surface 22 makes it difficult to achieve a liquid-tight fit (see FIG. 5B) between the female taper surface 22 and the male taper surface 132 . In contrast, in this embodiment, a dedicated through-hole 45 for injecting the adhesive 48 into the wire holding portion 40 is provided separately from the flow path 11 . By piercing the tip of the nozzle 70 into the through hole 45, the adhesive 48 can be reliably injected into the wire holding portion 40 through the through hole 45 (see FIG. 3). Since it is not necessary to insert the nozzle 70 into the first connector 20 , the adhesive 48 will not adhere to the female taper surface 22 . The work of injecting the adhesive 48 into the wire holding portion 40 does not require skill and is easy. Therefore, the stylet device 1 of this embodiment is easy to manufacture.

In the stylet device of Patent Document 3 described above, the inner peripheral surface of the inlet hole of the stylet connector and the hollow cylindrical member are fitted by an interference fit. Therefore, it is necessary to strictly manage the dimensional accuracy of these. Moreover, the operation of fitting the hollow cylindrical member into the inlet hole of the stylet connector is complicated. On the other hand, in the present embodiment, since the adhesive is injected into the wire holding portion 40, the dimensional accuracy of the wire holding portion 40 and its surroundings can be relaxed, and the step of fitting the two parts by interference fit is also possible. is unnecessary. In this respect as well, the stylet device 1 of the present embodiment is easy to manufacture.

In this embodiment, the inner dimension of the lumen 41 of the wire holding portion 40 is larger than the outer diameter of the guidewire 70 . This is advantageous in the following points. First, in the step of injecting the uncured adhesive 48 from the nozzle 50 into the wire holding portion 40 (see FIG. 3), the height of the upper surface 48a of the adhesive 48 (that is, the injection amount of the adhesive 48) is controlled. easy to do. Secondly, when the nozzle 70 is removed from the through-hole 45 after the adhesive 48 is injected, the lowering distance of the upper surface 48b of the adhesive 48 in the wire holding portion 40 becomes small, so that a sufficient amount of adhesive is required. A guidewire 70 can be secured to the stylet connector 10 at 48 . Third, even if the wire holding portion 40 is arranged eccentrically with respect to the central axis 10a of the stylet connector 10, the guide wire 70 can be arranged substantially coaxially with the central axis 10a. Therefore, the amount of eccentricity of the guide wire 50 with respect to the tube 150 is reduced when the stylet device 1 is inserted into the nasal catheter 100 (see FIG. 5B). This is advantageous in facilitating the task of inserting tube 150 into the patient.

In this embodiment, the second connector 30 of the stylet connector 10 has a male tapered surface 32 . Additionally, the second connector 30 is compatible with the male connector 130 of the catheter connector 110 . Therefore, a female connector connectable to the male connector 130 can also be connected to the second connector 30 . For example, a syringe used to aspirate gastric juice or inject air as described above can be connected to both the second connector 30 and the male connector 130 . Depending on the patient's condition, etc., the nasal catheter 100 may be inserted into the patient without using the stylet device 1 . In that case, connect the syringe to the male connector 130 of the catheter connector 110, suck gastric juice or inject air, and check whether the tip of the tube 150 has reached the desired position. can be done. Therefore, there is no need to prepare two types of syringes, one for the second connector 30 and one for the male connector 130 . A common syringe can be used whether or not the stylet device 1 is used.

The above embodiments are exemplary only. The present invention is not limited to the above embodiments, and can be modified as appropriate.

The shape of the wire holding portion 40 is not limited to the above embodiment, and can be changed arbitrarily. The wire holding part 40 only needs to be able to insert the proximal end of the guide wire 50 . The inner dimension of lumen 41 of wire retaining portion 40 may be approximately the same as the outer diameter of guidewire 50 .

The wire holding portion 40 may be provided with a mechanism for positioning the guide wire 50 in a direction parallel to a plane perpendicular to the central axis 10a. For example, the deepest portion (bottom portion) of the wire holding portion 40 may be provided with a recess into which the proximal end of the guide wire 50 is fitted. The guide wire 50 may be arranged coaxially with the wire holding portion 40 .

In the above embodiment, the wire holding portion 40 is eccentric with respect to the central axis 10a of the stylet connector 10, but the wire holding portion 40 may be arranged coaxially with the central axis 10a. This configuration facilitates positioning the guidewire 50 coaxially with the central axis 10a. For example, the wire holding portion 40 arranged coaxially with the central axis 10a and the inner peripheral surface of the flow path 11 may be connected by at least one supporting member extending along the radial direction. A through hole 45 is provided in this support member.

In the above-described embodiment, the wire holding part 40 is provided inside the connecting tube 12 between the first connector 20 and the second connector 30, but the position of the wire holding part 40 in the direction of the central axis 10a is is not limited to The wire holding portion 40 may be arranged on the second connector 30 side with respect to the first connector 20 . For example, part or all of the wire holding part 40 may be arranged in the channel 11 inside the male luer 31 of the second connector 30 .

In the present invention, the connecting pipe 12 may be omitted and the first connector 20 and the second connector 30 may be directly connected.

The through holes 45 need not extend straight. For example, the through hole 45 may extend radially outward from the wire holding portion 40 and then bend into a substantially L shape extending toward the first connector 20 in parallel with the central axis 10a. .

The female taper surface 46 may not be provided on the inner peripheral surface of the through hole 45 . The sealing structure between the nozzle 50 and the stylet connector 10 for preventing the adhesive 48 from leaking out to the outside may employ any structure other than the fitting structure between the nozzle 50 and the female taper surface 46. .

The outer peripheral surface of the first connector 20 may be provided with a protrusion (for example, a screw-like protrusion or a male screw) that can be screwed into the female screw 136 of the male connector 130 .

In the above embodiment, the second connector 30 is a male connector including the male luer 31 and the outer cylinder 35 provided with the female thread 36, but the present invention is not limited to this. The second connector 30 does not have to comply with the international standard ISO 80369-3, nor does it have to be compatible with the male connector 130 of the catheter connector 110 . The second connector 30 may not have the outer cylinder 35 and the female thread 36 . The second connector 30 need not be a male connector with a male luer 31, and may be a female connector with a female luer.

The stylet device of the present invention can also be used for enteral feeding catheters other than nasal catheters. Additionally, the stylet device of the present invention can be used with any catheter inserted into a patient's body other than enteral feeding. The catheter may include a catheter connector having a male luer and a catheter tube.

INDUSTRIAL APPLICABILITY The present invention can be widely used in the medical field without limitation, and can be preferably used in the field of enteral nutrition. Specifically, the stylet device of the present invention is suitable for use with insertion into an enteral feeding catheter. The catheter connector of the enteral feeding catheter may be provided with a male connector conforming to the international standard ISO80369-3.

1 stylet device 10 stylet connector 10a center axis of stylet connector 11 channel 20 first connector 22 female taper surface (first female taper surface)
30 Second connector 31 Male luer 40 Wire holding part 41 Wire holding part bore 42 Wire holding part opening edge 45 Through hole 46 Female taper surface (second female taper surface)
47 edge 48 of opening of through-hole adhesive 48a adhesive surface 48b in wire retainer adhesive surface 50 in through-hole guidewire

Claims (11)

A stylet device comprising a bendable guide wire and a stylet connector provided at the proximal end of the guide wire,
The stylet connector includes a first connector, a second connector, and a flow path passing through the stylet connector along its central axis such that the first connector and the second connector communicate with each other,
the first connector has a female tapered surface whose inner diameter increases toward the tip of the first connector;
A wire holding part having a lumen opening toward the first connector is provided in the flow path on the second connector side with respect to the first connector,
The proximal end of the guide wire is inserted into the lumen of the wire holding portion and fixed to the stylet connector via an adhesive filled in the lumen,
The guide wire is led out from the first connector through the channel,
A stylet device characterized in that a through-hole passing through the stylet connector is provided separately from the flow channel so as to communicate the inner cavity of the wire holding portion and the outside world of the stylet connector. . 2. The stylet device according to claim 1, wherein the through hole is inclined with respect to the central axis of the stylet connector so as to deviate toward the first connector as it moves away from the wire holding portion. The stylet device according to claim 1 or 2, wherein the edge of the opening of the through hole and the edge of the opening of the wire holding portion are located at approximately the same position in the central axis direction of the stylet connector. The stylet device according to any one of claims 1 to 3, wherein the inner peripheral surface of the through hole is provided with a female tapered surface whose inner diameter increases with increasing distance from the wire holding portion. The stylet device according to any one of claims 1 to 4, wherein the adhesive is continuously filled from the inner cavity of the wire holding portion to the through hole. 6. The surface of the adhesive in the wire holding portion and the surface of the adhesive in the through hole are at substantially the same position in the central axis direction of the stylet connector. The stylet device described. The stylet device according to any one of claims 1 to 6, wherein the wire holding portion is arranged eccentrically with respect to the central axis of the stylet connector. The stylet device of any one of claims 1-7, wherein the lumen of the wire holding portion has an inner dimension greater than the outer diameter of the guidewire. The stylet device according to any one of Claims 1 to 8, wherein the guide wire is arranged substantially coaxially with the central axis of the stylet connector. The stylet device according to any one of claims 1 to 9, wherein the second connector has a male tapered surface whose outer diameter decreases toward the tip of the second connector. The stylet device according to any one of claims 1 to 10, wherein the second connector is compatible with a male connector to which the first connector is connectable.

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