JP7632509B2 - Stylet Device - Google Patents

Description

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

Enteral nutrition is a method for administering liquids, including nutrients and medicines, to patients who are no longer able to take food orally. In enteral nutrition, liquids, such as nutrients and medicines, are administered to patients through a catheter tube inserted from the patient's nasal cavity to the stomach or small intestine. The catheter tube is small in diameter and flexible, so it easily curves or bends. It can be difficult to get such a catheter tube to reach the desired location through the nasal cavity. In this case, a metal guidewire (sometimes called a "stylet"), which is relatively more rigid than the catheter tube, is inserted into the catheter tube.

A catheter connector is provided at the base end of the catheter tube (the upstream end in the direction of the liquid flow). A stylet connector that can be connected to the catheter connector is provided at the base end of the guidewire. The guidewire is inserted into the catheter tube, and the stylet connector is connected to the catheter connector. The catheter tube, with its increased rigidity in this state, is inserted into the patient.

Whether the tip of the catheter tube has reached the desired position can be confirmed, for example, by aspirating gastric juice or injecting air through the catheter tube. Aspirating gastric juice or injecting air is performed, for example, by connecting a syringe to the stylet connector. When it is confirmed that the tip of the catheter tube has reached the desired position, the stylet connector is separated from the catheter connector, and the guide wire is pulled out from the catheter tube. The catheter tube is left in the patient. A connector provided at the downstream end of an enteral nutrition tube (sometimes called an "enteral nutrition administration set") is then connected to the catheter connector. The liquid stored in the container is administered to the patient through the enteral nutrition tube and the catheter tube in that order.

As a catheter connector, a male connector having a male luer and a female thread surrounding the male luer is under consideration for standardization as the international standard ISO80369-3 (see, for example, Patent Documents 1 and 2). In this case, the stylet connector must have a female luer into which the male luer of this male connector can be fitted. The guidewire must be derived from this female luer.

Patent document 3 describes a stylet device in which a guidewire is led out from a hollow entrance hole of a stylet connector. A hollow cylindrical member is fitted into the entrance hole by an interference fit. The base end of the guidewire is clamped between the inner circumferential surface of the entrance hole and the hollow cylindrical member.

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

In the stylet device of Patent Document 3, a hollow cylindrical member that is a separate part from the stylet connector is used to attach a guide wire to the stylet connector. This increases the number of parts that make up the stylet device. This makes the structure of the stylet device more complicated.

In addition, because the inner circumferential surface of the entrance hole of the stylet connector and the hollow cylindrical member must be fitted together with an interference fit, the dimensional accuracy of these components must be strictly controlled. The task of fitting the hollow cylindrical member into the entrance hole with an interference fit while the guidewire is sandwiched between the inner circumferential surface of the entrance hole and the hollow cylindrical member is complicated. For these reasons, manufacturing the stylet device is difficult.

The first object of the present invention is to provide a stylet device having a stylet connector that can be connected to a male luer of a catheter connector. The second object of the present invention is to provide a stylet device that has a simple structure and can be easily manufactured.

The stylet device of the present invention comprises a guidewire capable of being bent and deformed, and a stylet connector provided at the base end of the guidewire. The stylet connector comprises a first connector, a second connector, and a flow path penetrating the stylet connector along its central axis so that the first connector and the second connector communicate with each other. The first connector has a female tapered surface whose inner diameter increases as it approaches the tip of the first connector. A wire holding section having an inner cavity opening toward the first connector is provided in the flow path on the second connector side of the first connector. The base end of the guidewire is inserted into the inner cavity of the wire holding section and is fixed to the stylet connector via an adhesive filled in the inner cavity. The guidewire is led out of the first connector through the flow path. A through hole penetrating the stylet connector, separate from the flow path, is provided to communicate the inner cavity of the wire holding section with the outside world of the stylet connector.

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

The base end of the guidewire is fixed to the stylet connector via adhesive filled in the wire holding portion. Therefore, the structure 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 path. Uncured adhesive can be injected into the inner cavity of the wire holding portion through this through hole. Therefore, the stylet device of the present invention can be easily manufactured.

FIG. 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 according to one embodiment of the present invention. FIG. 2 is a cross-sectional view illustrating a step in the manufacture of a stylet device according to one embodiment of the present invention. FIG. 3 is a cross-sectional view illustrating a next step in the manufacture of a stylet device according to one embodiment of the present invention. FIG. 4A is a perspective view showing a state in which a guide wire 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 a stylet connector of a stylet device according to one embodiment of the present invention is connected to a catheter connector of a nasal catheter. FIG. 5B is a cross-sectional view of FIG. 5A.

In the stylet device of the present invention described above, the through hole may be inclined with respect to the central axis of the stylet connector so as to be displaced toward the first connector as it moves away from the wire holding portion. According to this aspect, when the stylet connector is held with the first connector facing upward, the opening of the through hole faces diagonally upward. In this state, it is easy to inject uncured adhesive into the wire holding portion through the through hole. Furthermore, after injection, the uncured adhesive does not leak out from the opening of the through hole. Therefore, the above aspect is advantageous in facilitating the manufacture of the stylet device.

The edge of the opening of the through hole may be at approximately the same position in the central axial direction of the stylet connector as the edge of the opening of the wire holding portion. 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 approximately the same height. Therefore, uncured adhesive injected into the through hole and the wire holding portion is unlikely to leak out from either the through hole or the wire holding portion. This is advantageous in facilitating the manufacture of the stylet device.

The inner circumferential 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 a 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 uncured adhesive from leaking out from between the inner circumferential 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, the adhesive reliably blocks communication between the flow path in the stylet connector and the outside world via the through hole.

The surface of the adhesive in the wire holding portion may be at approximately 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 disposed eccentrically with respect to the central axis of the stylet connector. This aspect is advantageous in ensuring a sufficient cross-sectional area of the flow path at the position where the wire holding portion is provided.

The inner cavity of the wire holding portion may have an inner dimension larger than the outer diameter of the guidewire. This aspect, first, makes it easier to manage the amount of uncured adhesive injected, second, makes it possible to fix the guidewire to the stylet connector with a sufficient amount of adhesive, and third, makes it easier to position the guidewire approximately coaxially with the central axis of the stylet connector.

The guidewire may be arranged approximately coaxially with the central axis of the stylet connector. According to this aspect, when the stylet connector is connected to the catheter connector, the eccentricity of the guidewire relative to the catheter tube is reduced. This is advantageous in facilitating the insertion of the catheter tube into the patient.

The second connector may have a male tapered surface whose outer diameter decreases as it approaches the tip of the second connector. According to this aspect, it becomes possible to connect a common female luer to both the male luer of the catheter connector to which the first connector can be connected and the second connector.

The second connector may be compatible with a male connector to which the first connector can be connected. According to this aspect, it becomes possible to connect a common female connector 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, 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 shows a simplified view of the main components constituting the embodiment of the present invention for the convenience of explanation. Therefore, within the scope of the present invention, any component not shown in the drawings may be added, or any component shown in the drawings may be modified or omitted. In different drawings, the same components are given the same reference numerals. For such components, duplicate explanations are omitted, and the explanations in the preceding drawings should be taken into consideration as appropriate.

Figure 1A is a perspective view of a stylet device 1 according to one embodiment of the present invention. Figure 1B is a cross-sectional view of the stylet device 1. The stylet device 1 includes a stylet connector 10 and a guidewire 50. In Figure 1B, the dashed line 10a is the central axis of the stylet connector 10. The cross section of Figure 1B is along the central axis 10a and the through hole 45 (described in detail below). For convenience of the following explanation, the direction of a straight line perpendicular to the central axis 10a is referred to as the "radial direction" or "diameter direction". In the radial direction, "outside" means the side away from the central axis 10a, and "inside" means the side approaching 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 are connected via a hollow connecting tube 12. A flow path 11 penetrates the stylet connector 10 along the central axis 10a so as to communicate between the first connector 20 and the second connector 30.

The first connector 20 has a hollow, generally cylindrical shape. The inner circumferential surface of the first connector 20 has a female taper surface (first female taper surface) 22 whose inner diameter increases as it approaches the tip of the first connector 20. The first connector 20 is a female lure having the female taper surface 22. It is preferable that the diameter and taper angle of the female taper surface 22 match the male taper surface 132 (see Figures 4A and 4B described below) of the male lure 131 provided on the catheter connector 110 of the nasal catheter 100 to which the stylet device 1 is adapted, so that the male taper surface 132 comes into surface contact with and fits (so-called taper fit) with the male taper surface 132. The first connector 20 (particularly the female taper 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, approximately cylindrical shape. The outer peripheral surface of the male luer 31 has a male taper surface 32 whose outer diameter becomes smaller as it approaches the tip of the male luer 31. The second connector 30 further has an approximately cylindrical outer tube 35 that is radially spaced from the male luer 31 and surrounds the male luer 31. A female thread 36 is provided on the inner peripheral surface of the outer tube 35. It is preferable that the second connector 30 is compatible with the male connector 130 (see Figures 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 the male taper surface 32 and the female thread 36) may comply with the 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 portion 40 has an overall generally bottomed, generally hollow cylindrical shape (or generally container shape, or generally box shape). The longitudinal direction (long axis) of the wire holding portion 40 is parallel to the central axis 10a. The inner cavity 41 of the wire holding portion 40 opens toward the first connector 20. The inner cavity 41 is connected to the flow path 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 ensuring a sufficient cross-sectional area of the flow path 11 at the position where the wire holding portion 40 is provided.

The through hole 45 penetrates the stylet connector 10 so as to communicate the inner cavity 41 of the wire holding portion 40 with the outside of the stylet connector 10. The through hole 45 extends from the deepest part of the inner cavity 41 of the wire holding portion 40 (i.e., the end of the inner cavity 41 on the second connector 30 side) or its vicinity outward to the outer circumferential surface of the stylet connector 10. The through hole 45 is inclined with respect to the central axis 10a (i.e., it 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 be displaced toward the first connector 20 as it moves away from the wire holding portion 40. The edge 47 of the opening of the through hole 45 on the opposite side to the wire holding portion 40 is located on the first connector 20 side in the direction of the central axis 10a with respect to the connection point 44 (see FIG. 2) between the through hole 45 and the wire holding portion 40. Additionally, the edge 47 of the opening of the through hole 45 is located at approximately the same position in the direction of the central axis 10a as the edge 42 of the opening of the wire holding portion 40. The inner peripheral surface of the through hole 45 has a female taper surface (second female taper surface) 46 near the edge 47, whose inner diameter increases as it moves away from the wire holding portion 40.

The guidewire 50 is inserted into the flow path 11 and the inner cavity 41 of the wire holding portion 40. The base end (or proximal end; the upper end of the guidewire 50 in FIG. 1B) of the guidewire 50 reaches the deepest part of the inner cavity 41 of the wire holding portion 40 (i.e., the bottom of the wire holding portion 40). The inner dimension of the inner cavity 41 of the wire holding portion 40 (particularly, the inner dimension of the inner cavity 41 along the radial direction) is larger than the outer diameter of the guidewire 50. The guidewire 50 is disposed in the inner cavity 41 of the wire holding portion 40 eccentrically with respect to the axis of the wire holding portion 40 so as to approach the central axis 10a (preferably so as to be coaxial with the central axis 10a). The base end of the guidewire 50 is fixed to the stylet connector 10 via an adhesive 48 filled in the inner cavity 41 of the wire holding portion 40. The guidewire 50 is led out of the first connector 20 through the flow path 11.

The adhesive 48 is continuously filled from the inner cavity 41 of the wire holding portion 40 to the through hole 45. The surface 48a of the adhesive 48 in the wire holding portion 40 is located on the second connector 30 side in the direction of the central axis 10a relative to the edge 42 of the opening of the wire holding portion 40. In addition, the surface 48a of the adhesive 48 in the wire holding portion 40 is located at approximately the same position in the direction of the central axis 10a as the surface 48b of the adhesive 48 in the through hole 45.

The stylet connector 10 is preferably made of a hard material. In addition, the material of the stylet connector 10 is preferably transparent or translucent. Specifically, resin materials such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, and hard polyvinyl chloride can be used. The stylet connector 10 can be manufactured as a single component by injection molding or the like using these resin materials.

The guidewire 50 is a long, thin, string-like object that has a suitable degree of flexibility (or pliability) so that it can be curved 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 rigidity (elasticity) of the catheter tube 150 and prevent kinking (see Figs. 4B and 5B described later). The outer diameter of the guidewire 50 is smaller than the inner diameter of the catheter tube 150. The configuration of the guidewire 50 is not limited, and may be the same as the configuration of a known guidewire used in an enteral nutrition catheter. For example, the guidewire 50 may be a stranded wire in which strands of wires are twisted together. The material of the strands is not limited, and may be a metal such as stainless steel or a resin with relatively high rigidity (high elasticity) such as nylon or polyester. Furthermore, the guidewire 50 may be a combination of metal and resin.

A method for manufacturing the stylet device 1 is described.

First, as shown in FIG. 2, the stylet connector 10 is held with a jig or the like (not shown) so that the first connector 20 faces up and the central axis 10a is parallel to the vertical direction. The guidewire 50 is inserted into the wire holding portion 40 through the first connector 20. The base end of the guidewire 50 (the lower end of the guidewire 50 in FIG. 2) abuts against the bottom of the wire holding portion 40 in the vertical direction. The guidewire 50 is held with a jig or the like (not shown) in a state where the guidewire 50 is parallel to the central axis 10a and is as close to the central axis 10a as possible (or is coaxial with the central axis 10a) within the inner cavity 41 of the wire holding portion 40.

3, the nozzle 70 is inserted into the through hole 45. The base end (not shown) of the nozzle 70 is connected to the tip of a syringe (not shown) that stores, for example, uncured adhesive 48. Since the opening of the through hole 45 faces diagonally upward, it is easy to insert the nozzle 70. The uncured adhesive 48 is injected into the through hole 45 and the inner cavity 41 of the wire holding part 40 through the nozzle 70. The outer peripheral surface of the tip of the nozzle 70 fits liquid-tightly into the female tapered surface 46 of the inner peripheral surface of the through hole 45. For this reason, the adhesive 48 does not leak out to the outside world from between the inner peripheral surface of the through hole 45 and the nozzle 70. There is no limit to the amount of adhesive 48 injected, but it may be adjusted so that, for example, the upper surface (liquid surface) 48a of the adhesive 48 in the wire holding part 40 reaches a position equal to or slightly lower than the edge 42 of the opening of the wire holding part 40. In this case, the upper surface 48a of the adhesive 48 is located higher than the tip of the nozzle 70. If the stylet connector 10 is transparent, the liquid surface 48a of the adhesive 48 can be seen through the stylet connector 10. Any adhesive capable of fixing the guidewire 50 to the stylet connector 10 can be used as the adhesive 48. The adhesive 48 is preferably a liquid with a relatively low viscosity. Specifically, an epoxy resin-based or ultraviolet-curing adhesive can be used. The translucency of the stylet connector 10 is advantageous for curing the ultraviolet-curing adhesive.

After the adhesive 48 is injected, the nozzle 70 is removed from the through hole 45. When the nozzle 70 is removed, 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 slightly lowered and slightly raised so that they are at approximately the same height (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 approximately the same height. Therefore, even if the heights of the upper surfaces 48a and 48b change in this way, the adhesive 48 does not leak out of the wire holding portion 40 and the through hole 45.

The adhesive 48 is then cured. Thus, the stylet device 1 (see Figures 1A and 1B) is obtained.

The stylet device 1 is inserted into the enteral nutrition catheter before the enteral nutrition catheter is inserted into the patient. The method of using the stylet device 1 will be explained using the example in which the enteral nutrition catheter is a nasal catheter.

Figure 4A is a perspective view showing the state in which the guide wire 50 of the stylet device 1 is inserted into the nasal catheter 100. Figure 4B is a cross-sectional view thereof. The nasal catheter 100 comprises 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 passes through the catheter connector 110 so that the male connector 130 and the connecting tube 120 are in communication.

The male connector 130 includes a male lure 131 having a hollow, approximately cylindrical shape, an outer cylinder 135 having an approximately cylindrical shape that is radially spaced from the male lure 131 and surrounds the male lure 131, and a female screw 136 provided on the inner peripheral surface of the outer cylinder 135. The flow path 111 penetrates the male lure 131 along its longitudinal direction. The outer peripheral surface of the male lure 131 has a male tapered surface 132 whose outer diameter becomes smaller as it approaches the tip of the male lure 131. The male connector 130 can be connected to and disconnected from a female connector (not shown) provided at the downstream end of an enteral nutrition tube (enteral nutrition administration set) through which a liquid to be administered to a patient flows. The male connector 130 and the female connector may comply with the international standard ISO 80369-3. The male connector 130 may not have the outer cylinder 135 and the female screw 136.

The connection tube 120 also has a generally hollow cylindrical shape. The connection tube 120 is arranged coaxially with the male lure 131. A tube 150 is inserted into the connection tube 120. The tube 150 is fixed to the inner surface of the connection tube 120 via adhesive (not shown). The male lure 131 and the tube 150 are in communication. A pair of grip pieces 125 protrude radially outward from the outer surface of the connection tube 120 to make it easier to grip the catheter connector 110.

In the state shown in Figures 4A and 4B, connect the stylet connector 10 to the catheter connector 110.

Figure 5A is a perspective view showing the state in which the stylet connector 10 of the stylet device 1 is connected to the catheter connector 110 of the nasal catheter 100. Figure 5B is a cross-sectional view thereof. The male lure 131 of the catheter connector 110 is inserted into the first connector (female lure) 20 of the stylet connector 10. The first connector 20 is inserted into the gap between the male lure 131 and the outer tube 135. The female taper surface 22 of the first connector 20 and the male taper surface 132 of the male lure 131 have the same diameter and taper angle. Therefore, the female taper surface 22 and the male taper surface 132 come into surface contact and fit liquid-tightly (so-called taper fit). Such a connection between the first connector 20 and the male lure 131 is generally called 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 are sequentially connected. The guidewire 50 is inserted into the flow path 111 and the tube 150. Although not shown in the figure, the tip (distal end) of the guidewire 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 Figures 5A and 5B, the tip of the tube 150 (not shown) is inserted into the patient's nasal cavity. The tube 150 has increased rigidity (elasticity) due to the guide wire 50 being inserted therein. This is advantageous in allowing the tip of the tube 150 to reach a desired location (e.g., the stomach or small intestine).

Whether the tip of the tube 150 has reached the desired position can be confirmed, for example, by aspirating gastric juice or injecting air through the tube 150. Aspirating gastric juice or injecting air can be performed by connecting, for example, a syringe to the second connector 30 (particularly its male lure 31) of the stylet connector 10. When it is confirmed that the tip of the tube 150 has reached the desired position, the stylet connector 10 is separated from the catheter connector 110, and the guide wire 50 is pulled out from the tube 150. The stylet device 1 is separated from the nasal catheter 100. The nasal catheter 100 is placed in the patient. A female connector provided at the downstream end of the enteral nutrition tube is connected to the male connector 130. A liquid is administered to the patient through the enteral nutrition tube and the nasal catheter 100.

As described above, in the stylet device 1 of this embodiment, the base 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. The first connector 20 is a female lure having a female tapered surface 22. The guide wire 50 is led out from the first connector 20. Since the wire holding portion 40 is located further back (toward the second connector 30) than the first connector 20, the wire holding portion 40 does not interfere with the engagement between the first connector 20 (female tapered surface 22) and the male lure 131 (male tapered surface 132) of the catheter connector 110 (see FIG. 5B). It is possible to connect the stylet connector 10 of the stylet device 1 to the catheter connector 110 equipped with a male connector 130 that complies with the international standard ISO 80369-3.

The base end of the guidewire 50 is fixed to the stylet connector 10 via adhesive 48 (see FIG. 1B). This makes the structure of the stylet device 1 simple. In the stylet device of Patent Document 3 mentioned above, a hollow cylindrical member is used to attach the guidewire to the stylet connector. In this embodiment, a part separate from the stylet connector, such as a hollow cylindrical member, is not required.

The uncured adhesive 48 is injected into the inner cavity 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 is conceivable in which the through hole 45 is not provided, and the nozzle 70 is inserted into the first connector 20 in the state shown in FIG. 3 to inject adhesive into the inner cavity 41 of the wire holding portion 40. However, this method has the following problems. First, the guide wire 50 in the first connector 20 makes it difficult for the tip of the nozzle 70 to access the wire holding portion 40. Second, if the tip of the nozzle 70 accidentally touches the female tapered surface 22 in the process of approaching the tip of the nozzle 70 to the wire holding portion 40, or in the process of withdrawing the nozzle 70 from the first connector 20 after injecting the adhesive into the wire holding portion 40, the adhesive may adhere to the female tapered surface 22. The adhesive adhering to the female tapered surface 22 makes it difficult to achieve a liquid-tight fit between the female tapered surface 22 and the male tapered surface 132 (see FIG. 5B). 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. The tip of the nozzle 70 can be inserted into the through hole 45 to reliably inject the adhesive 48 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 be attached to the female tapered surface 22. The task of injecting the adhesive 48 into the wire holding portion 40 does not require skill and is simple. For this reason, the stylet device 1 of this embodiment is easy to manufacture.

In the stylet device of Patent Document 3 described above, the inner circumferential surface of the entrance hole of the stylet connector and the hollow cylindrical member are fitted together by an interference fit. This requires strict control of their dimensional accuracy. Furthermore, the task of fitting the hollow cylindrical member into the entrance hole of the stylet connector is cumbersome. In contrast, in this embodiment, adhesive is injected into the wire holding portion 40, so the dimensional accuracy of the wire holding portion 40 and its surroundings can be relaxed, and the process of fitting the two parts together by an interference fit is not required. In this respect, too, the stylet device 1 of this 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 has the following advantages. First, in the process of injecting uncured adhesive 48 from the nozzle 50 into the wire holding portion 40 (see FIG. 3), it is easy to manage the height of the upper surface 48a of the adhesive 48 (i.e., the amount of adhesive 48 injected). Second, 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 the guidewire 70 can be fixed to the stylet connector 10 with a sufficient amount of adhesive 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 guidewire 70 can be arranged approximately coaxially with the central axis 10a. Therefore, the amount of eccentricity of the guidewire 50 with respect to the tube 150 when the stylet device 1 is inserted into the nasal catheter 100 (see FIG. 5B) is reduced. This is advantageous in making it easier to insert the tube 150 into the patient.

In this embodiment, the second connector 30 of the stylet connector 10 has a male taper surface 32. Furthermore, the second connector 30 is compatible with the male connector 130 of the catheter connector 110. Therefore, a female connector that can be connected 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 can be connected to either the second connector 30 or the male connector 130. Depending on the patient's condition, the nasal catheter 100 may be inserted into the patient without using the stylet device 1. In that case, the syringe can be connected to the male connector 130 of the catheter connector 110 to aspirate gastric juice or inject air to check whether the tip of the tube 150 has reached the desired position. 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 regardless of whether the stylet device 1 is used.

The above embodiments are merely examples. 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 as desired. The wire holding portion 40 only needs to be able to insert the base end of the guidewire 50. The inner dimension of the lumen 41 of the wire holding portion 40 may be approximately the same as the outer diameter of the guidewire 50.

The wire holding portion 40 may be provided with a mechanism for positioning the guidewire 50 in a direction parallel to a plane perpendicular to the central axis 10a. For example, a recess into which the base end of the guidewire 50 fits may be provided at the deepest part (bottom) of the wire holding portion 40. The guidewire 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 makes it easier to arrange the guide wire 50 coaxially with the central axis 10a. For example, the wire holding portion 40 arranged coaxially with the central axis 10a and the inner circumferential surface of the flow path 11 may be connected by at least one support member extending along the radial direction. The through hole 45 is provided in this support member.

In the above embodiment, the wire holding portion 40 was provided in the connecting tube 12 between the first connector 20 and the second connector 30, but the position of the wire holding portion 40 in the direction of the central axis 10a is not limited to this. The wire holding portion 40 only needs to be located on the second connector 30 side relative to the first connector 20. For example, a part or all of the wire holding portion 40 may be located in the flow path 11 in the male lure 31 of the second connector 30.

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

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

The female tapered surface 46 does not have to be provided on the inner peripheral surface of the through hole 45. The sealing structure between the nozzle 50 and the stylet connector 10 to prevent the adhesive 48 from leaking to the outside world may be any structure other than the fitting structure between the nozzle 50 and the female tapered surface 46.

The outer peripheral surface of the first connector 20 may be provided with a protrusion (e.g., a helical protrusion or a male thread) that can be screwed into the female thread 136 of the male connector 130.

In the above embodiment, the second connector 30 was a male connector equipped with a male luer 31 and an outer tube 35 provided with a 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, and does not have to be compatible with the male connector 130 of the catheter connector 110. The second connector 30 does not have to have an outer tube 35 and a female thread 36. The second connector 30 does not have to be a male connector equipped with a male luer 31, and may be a female connector equipped with a female lure.

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

The present invention can be used in a wide range of medical fields, including, but not limited to, the field of enteral nutrition. Specifically, the stylet device of the present invention is suitable for use by being inserted into an enteral nutrition catheter. The catheter connector of the enteral nutrition catheter may be provided with a male connector that complies with the international standard ISO 80369-3.

1 Stylet device 10 Stylet connector 10a Center axis of stylet connector 11 Flow path 20 First connector 22 Female taper surface (first female taper surface)
30 Second connector 31 Male luer 40 Wire holding portion 41 Internal cavity of wire holding portion 42 Edge of opening of wire holding portion 45 Through hole 46 Female taper surface (second female taper surface)
47 Edge of opening of through hole 48 Adhesive 48a Surface of adhesive in wire holding portion 48b Surface of adhesive in through hole 50 Guide wire

Claims (10)

A stylet device comprising a guidewire capable of being bent and deformed, and a stylet connector provided at a proximal end of the guidewire,
the stylet connector comprises a first connector, a second connector, and a flow passage extending through the stylet connector along a central axis thereof so as to communicate between the first connector and the second connector;
the first connector has a female tapered surface whose inner diameter increases toward a tip of the first connector,
a wire holding portion having an inner cavity opening toward the first connector is provided in the flow path on the second connector side with respect to the first connector,
a proximal end of the guide wire is inserted into the inner cavity of the wire holding portion and is fixed to the stylet connector via an adhesive that fills the inner cavity;
The guide wire is led out from the first connector through the flow passage,
a through hole penetrating the stylet connector separately from the flow path is provided so as to communicate the inner cavity of the wire holding portion with the outside of the stylet connector;
A stylet device, wherein the through hole is inclined with respect to a central axis of the stylet connector so as to be biased toward the first connector as it moves away from the wire holding portion. The stylet device according to claim 1, wherein the surface of the adhesive in the wire holding portion is at approximately the same position in the central axis direction of the stylet connector as the surface of the adhesive in the through hole. The stylet device according to claim 1 or 2 , wherein an edge of the opening of the through hole is located at approximately the same position as an edge of the opening of the wire holding portion in the central axial direction of the stylet connector. The stylet device according to any one of claims 1 to 3 , wherein an inner circumferential 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. The stylet device according to any one of claims 1 to 5 , wherein the wire holding portion is disposed eccentrically with respect to a central axis of the stylet connector. The stylet device according to any one of claims 1 to 6 , wherein the inner cavity of the wire holding portion has an inner dimension larger than an outer diameter of the guidewire. The stylet device according to any one of claims 1 to 7 , wherein the guide wire is disposed substantially coaxially with a central axis of the stylet connector. The stylet device according to any one of claims 1 to 8 , 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 9 , wherein the second connector is compatible with a male connector to which the first connector can be connected.

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