WO2014103599A1

WO2014103599A1 - Catheter

Info

Publication number: WO2014103599A1
Application number: PCT/JP2013/081953
Authority: WO
Inventors: 川口道寛
Original assignee: テルモ株式会社
Priority date: 2012-12-25
Filing date: 2013-11-27
Publication date: 2014-07-03
Also published as: JP6326377B2; JPWO2014103599A1

Abstract

The hub (14) of a catheter (10) has a shaft holding section (28) for holding the proximal end of a shaft (12) and also has a hub lumen forming section (34) provided closer to the proximal end side than the shaft holding section (28) and forming a hub lumen (24) connecting to the lumen (13) of the shaft (12). The hub lumen forming section (34) is provided closer to the proximal end side than the shaft holding section (28) with a stepped section (30) provided between the hub lumen forming section (34) and the shaft holding section (28), the stepped section (30) having a diameter reduced relative to the diameter of the shaft holding section (28). The stepped section (30) has an inner edge (38) having an inner diameter reduced toward the proximal end.

Description

catheter

The present invention relates to a catheter.

Conventionally, it has been widely performed to introduce a catheter into a living organ such as a blood vessel to inspect and treat a lesioned portion (for example, a stenosis) in the living organ. This type of catheter generally has an elongate shaft constituting the catheter body and a hub connected to the proximal end of the shaft (see, for example, US Pat. No. 6,355,027).

In the use of such a catheter, in order to reach the distal end of the catheter to the target site in the living body, it is necessary to advance the shaft selectively in a complicatedly branched blood vessel or body cavity. For this reason, usually, a guide wire is inserted through the lumen of the catheter, and the catheter is caused to travel along the guide wire in the blood vessel or body cavity with the tip of the guide wire preceding the tip of the catheter. .

By the way, in order to insert the guide wire inserted into the body lumen prior to the catheter into the lumen of the catheter, the proximal end portion of the guide wire is inserted from the distal end of the shaft of the catheter, and the base of the guide wire is inserted. The end must be moved in the proximal direction relative to the shaft, and the hub lumen must be passed in the proximal direction. At this time, if there is a step between the inner peripheral part of the shaft and the inner peripheral part of the hub (the inner peripheral part forming the hub lumen), the guide wire moves by being caught by the base end of the guide wire. Resistance may occur and it may be difficult to move the guide wire further proximally within the hub. In particular, the proximal end portion of the guide wire may be bent and used. In such a case, the proximal end portion of the guide wire is easily caught by the step.

The present invention has been made in consideration of such problems, and when the guide wire is inserted from the distal end of the catheter and the proximal end portion of the guide wire is passed through the hub, the proximal end portion of the guide wire in the hub. An object of the present invention is to provide a catheter that can be smoothly moved in the proximal direction.

In order to achieve the above object, the present invention provides a catheter comprising a shaft constituting a catheter body and a hub provided at the proximal end of the shaft, the hub holding the proximal end of the shaft. A shaft holding portion; and a hub lumen forming portion that is provided on a proximal side of the shaft holding portion and that communicates with a lumen of the shaft. The hub lumen forming portion includes: It is provided on the base end side with respect to the shaft holding part through a step part reduced in diameter with respect to the shaft holding part, and the step part has an inner edge part whose inner diameter decreases toward the base end direction. To do.

According to the above configuration, the inner diameter of the inner edge of the stepped portion reduced in diameter relative to the proximal end of the shaft in the hub decreases toward the proximal end. Therefore, even when there is a step between the inner periphery of the shaft and the inner periphery of the hub, when inserting the guide wire from the distal end of the catheter and passing the proximal end of the guide wire through the hub, the proximal direction Due to the guide action of the inner edge portion whose inner diameter decreases toward the upper end, the proximal end portion of the guide wire is not caught by the stepped portion, so that the proximal end portion of the guide wire is suitably guided into the hub lumen. As a result, the proximal end portion of the guide wire can be smoothly moved in the proximal direction within the hub.

In the above catheter, the proximal end of the shaft may abut on the stepped portion provided on the hub.

According to the above configuration, the proximal end portion of the guide wire does not enter between the proximal end of the shaft and the stepped portion, and the proximal end portion of the guide wire is moved more smoothly in the proximal direction within the hub. Can do.

In the above catheter, the inner edge portion provided on the hub may have an arcuate shape in a longitudinal section of the hub.

According to the above configuration, when the guide wire is inserted from the distal end of the catheter and the proximal end portion of the guide wire is passed through the hub, the guide wire has an R shape even when the proximal end portion of the guide wire contacts the stepped portion. The inner edge portion smoothly guides the proximal end portion of the guide wire to the axial line side of the hub.

In the above catheter, the inner edge portion provided on the hub may have a straight shape in a longitudinal section of the hub.

According to the above configuration, when the guide wire is inserted from the distal end of the catheter and the proximal end portion of the guide wire is passed through the hub, the guide wire is inclined linearly even when the proximal end portion of the guide wire contacts the stepped portion. The proximal end portion of the guide wire is smoothly guided to the axial side of the hub by the inner edge portion.

According to the catheter of the present invention, when the guide wire is inserted from the distal end of the catheter and the proximal end portion of the guide wire is passed through the hub, the guide action of the inner edge portion whose inner diameter decreases toward the proximal end direction, Since the proximal end portion of the guide wire is not caught by the stepped portion, the proximal end portion of the guide wire is suitably guided into the hub lumen. As a result, the proximal end portion of the guide wire can be smoothly moved in the proximal direction within the hub.

1 is a partially omitted side view of a catheter according to an embodiment of the present invention. FIG. 2 is a partially omitted longitudinal sectional view of the hub of the catheter shown in FIG. 1. 3A is a partially omitted longitudinal sectional view of the hub shown in FIG. 2, and FIG. 3B is a partially omitted longitudinal sectional view of the hub according to a modification. FIG. 4A is a first diagram illustrating an operation of moving the proximal end portion of the guide wire in the proximal direction in the hub, and FIG. 4B moves the proximal end portion of the guide wire in the proximal direction in the hub. FIG. 4C is a third diagram illustrating an operation of moving the proximal end portion of the guide wire in the proximal direction in the hub.

Hereinafter, preferred embodiments of the catheter according to the present invention will be described with reference to the accompanying drawings.

FIG. 1 is a partially omitted side view of a catheter 10 according to an embodiment of the present invention. The catheter 10 is inserted into a blood vessel or body cavity so that the tip reaches a target site, and is used to inject a therapeutic drug or a diagnostic contrast medium. As shown in FIG. 1, the catheter 10 includes a thin and long shaft 12, a hub 14 connected to the proximal end of the shaft 12, and a strain relief 16 provided at a connection portion of the shaft 12 to the hub 14. With.

The shaft 12 constitutes a catheter body that is inserted into a living body lumen such as a blood vessel, and has a flexibility in which a lumen 13 (see also FIG. 2) communicating from the distal end to the proximal end is formed. It is a long and thin tubular member. The length of the shaft 12 is, for example, about 500 mm to 2000 mm, and preferably about 1000 mm to 1500 mm.

The outer diameter of the shaft 12 is, for example, about 0.3 mm to 3 mm, preferably about 0.4 mm to 2 mm. The inner diameter of the shaft 12 is, for example, about 0.2 mm to 2.5 mm, preferably about 0.3 mm to 1.8 mm. The outer diameter and inner diameter of the shaft 12 may be smaller toward the distal end side. The most distal portion of the shaft 12 may have a taper.

An X-ray impermeable marker (contrast marker) 18 is fixed to the outer peripheral surface in the vicinity of the most distal portion of the shaft 12. The radiopaque marker 18 is formed of a material having radiopacity that is made of gold, platinum, or the like, so that the distal end position of the catheter 10 can be viewed in vivo under radiography. Is.

The hub 14 is a member having a hollow structure that holds the proximal end of the shaft 12 at the distal end thereof, and other instruments such as a syringe can be connected to the proximal end. The hub 14 can be made of, for example, a hard resin such as polycarbonate, polyethylene, or polypropylene. In the present embodiment, the hub 14 is made of a transparent material (such as polycarbonate). Thereby, when the guide wire 42 (see FIG. 4A and the like) is inserted, the presence of the end portion of the guide wire 42 in the hub 14 can be confirmed, which is preferable.

The strain relief 16 is for preventing bending (kinking) at the connection portion of the shaft 12 to the hub 14. For example, the strain relief 16 is formed of a resin having moderate flexibility and rigidity formed in a tapered tube shape. It is a member. The strain relief 16 can be made of a material similar to that of the shaft 12.

Next, a specific configuration of the hub 14 will be described. FIG. 2 is a partially omitted vertical sectional view of the hub 14. As shown in FIG. 2, the hub 14 includes a hollow body portion 20 and a plurality (two in the illustrated example) of blade portions 22 protruding from the outer surface of the body portion 20. The body portion 20 includes an inner peripheral portion that forms a hub lumen 24 that communicates with the lumen 13 of the shaft 12 (hereinafter referred to as “hub lumen forming portion 34”), and a proximal end that opens at the proximal end of the hub 14. And an opening 26.

Further, a shaft holding portion 28 having a cylindrical inner surface is provided on the distal end side of the hub 14. The base end portion 32 of the shaft 12 is held and fixed to the shaft holding portion 28. A hub lumen forming portion 34 is provided on the proximal side of the shaft holding portion 28 via a step portion 30 having a diameter reduced with respect to the shaft holding portion 28.

At least a portion on the proximal end side of the hub lumen forming portion 34 (a range having a predetermined length from the proximal end opening 26 to the distal end side) is configured as a taper whose inner diameter decreases at a predetermined rate toward the distal end direction. . Within this taper, a luer taper part to which other devices (for example, a syringe etc.) can be connected is present on the base side. In the hub lumen forming portion 34, the taper existing on the tip side of the luer taper portion may be a taper having the same inclination angle as the luer taper portion or a taper having an inclination angle different from the taper.

In the present embodiment, the hub 14 and the shaft 12 are manufactured separately, and the proximal end portion 32 of the shaft 12 is inserted into the distal end (shaft holding portion 28) of the hub 14, and adhesion, thermal fusion, or the like is performed. These are joined by appropriate joining means. The hub 14 may be provided at the proximal end of the shaft 12 by insert molding.

FIG. 3A is a partially omitted vertical sectional view of the hub 14 shown in FIG. As shown in FIG. 3A, the base end surface 12 a of the shaft 12 abuts on the tip 30 a of the stepped portion 30, thereby positioning the shaft 12 with respect to the hub 14. A slight gap may be provided between the proximal end surface 12a of the shaft 12 and the distal end 30a of the stepped portion 30, but such a gap is provided in the guide wire 42 (see FIG. 4A and the like) in the hub 14. When the wire is passed in the proximal direction, it is preferable that the proximal end portion 43 of the guide wire 42 does not enter.

The inner diameter R1 of the proximal end side of the inner peripheral portion 36 forming the lumen 13 of the shaft 12 (hereinafter referred to as “shaft lumen forming portion 36”) is larger than the inner diameter R2 of the distal end portion of the hub lumen forming portion 34. Largely, the step portion 30 is formed by this inner diameter difference. When the guide wire 42 is inserted from the distal end of the catheter 10 and the proximal end portion 43 of the guide wire 42 is passed through the hub 14, the movement of the guide wire 42 in the proximal direction is not hindered by the step portion 30. The step portion 30 has an inner edge portion 38 (inner peripheral portion) whose inner diameter decreases in the proximal direction.

As shown in FIG. 3A, specifically, in the present embodiment, the inner edge portion 38 of the stepped portion 30 has a shape curved in an arc shape in the longitudinal section of the hub 14 (R shape: so as to rise toward the inside of the hub 14. Curved shape). The R shape is provided over the entire circumference of the inner edge portion 38 in the circumferential direction. The inner diameter of the innermost portion 38 is the same as or larger than the diameter of the proximal end opening of the shaft 12 (the inner diameter R1 of the shaft 12).

By having the inner edge portion 38 configured in this manner, the proximal end portion of the guide wire 42 is inserted when the guide wire 42 is inserted from the distal end of the catheter 10 and the proximal end portion 43 of the guide wire 42 is passed through the hub 14. Even when 43 contacts the stepped portion 30, the proximal end portion 43 of the guide wire 42 is smoothly guided to the axis a side of the hub 14 by the inner edge portion 38 having an R shape.

In the hub 14, instead of the R-shaped inner edge 38, an inner edge 39 that is inclined linearly with respect to the axis a in the longitudinal section of the hub 14 may be employed as shown in FIG. 3B. This linearly inclined shape is provided over the entire circumference of the inner edge 39 in the circumferential direction. The inner diameter of the distal end portion of the inner edge portion 39 is the same as or larger than the diameter of the proximal end opening of the shaft 12.

Even when the guide wire 42 is inserted from the distal end of the catheter 10 and the proximal end portion 43 of the guide wire 42 is passed through the hub 14 by the inner edge portion 39 having such a linear shape, the proximal end portion 43 of the guide wire 42 is inserted. Even when the contact with the step portion 30, the base end portion 43 of the guide wire 42 is smoothly guided to the axis a side of the hub 14 by the linearly inclined inner edge portion 39.

The catheter 10 according to the present embodiment is basically configured as described above, and the operation and effect of the catheter 10 will be described below mainly with reference to FIGS. 4A to 4C. In this example, the operation of inserting the guide wire 42 with the proximal end portion 43 bent from the distal end of the catheter 10 (the distal end opening of the shaft 12) and passing the proximal end portion 43 of the guide wire 42 into the hub 14 will be described. Even when the guide wire 42 in which the proximal end portion 43 is not bent (the proximal end portion 43 is linear) is inserted from the distal end of the catheter 10, the following effects can be obtained.

When the guide wire 42 having the bent proximal end 43 is inserted from the distal end opening of the shaft 12 of the catheter 10 and moved relative to the catheter 10 in the proximal direction, as shown in FIG. Eventually, the proximal end portion 43 of the guide wire 42 reaches the proximal end portion 32 of the shaft 12. When the guide wire 42 is further moved in the proximal direction with respect to the catheter 10, the bent proximal end portion 43 of the guide wire 42 may come into contact with the stepped portion 30 in the hub 14, as shown in FIG. 4B. is there.

By the way, in the conventional catheter hub, when the proximal end portion 43 of the guide wire 42 comes into contact with a stepped portion provided on the proximal end side of the shaft in the hub, the proximal end portion 43 of the guide wire 42 contacts the stepped portion. May be caught to prevent the guide wire 42 from moving, and it may be difficult to move the guide wire 42 further in the proximal direction with respect to the hub.

In contrast, in the catheter 10 of the present invention, the inner edge portion 38 of the step portion 30 provided in the hub 14 is formed so that the inner diameter decreases toward the proximal direction. Even when the end portion 43 comes into contact with the stepped portion 30, the base end portion 43 is guided (guided) toward the axis a by the inner edge portion 38. Therefore, as shown in FIG. 4C, the guide wire 42 is not prevented from moving by the step portion 30, and the guide wire 42 can be smoothly moved in the proximal direction in the hub 14.

In particular, in the case of the guide wire 42 in which the base end portion 43 is bent, the base end portion 43 is likely to come into contact with the stepped portion 30 when passing through the hub 14 as compared with the case where the base end portion 43 is linear. However, even when such a bent base end portion 43 comes into contact with the stepped portion 30, as shown in FIGS. 4B and 4C, the guide action of the inner edge portion 38 whose inner diameter decreases toward the base end direction causes the The proximal end 43 is smoothly guided into the hub lumen 24.

As described above, according to the catheter 10 according to the present embodiment, the inner diameter of the inner edge portion 38 of the stepped portion 30 that is reduced in diameter relative to the proximal end of the shaft 12 in the hub 14 decreases in the proximal direction. It has become a thing. Therefore, even when there is a stepped portion 30 between the shaft lumen forming portion 36 and the hub lumen forming portion 34, the guide wire 42 is inserted from the distal end of the catheter 10, and the proximal end portion 43 of the guide wire 42 is connected to the hub. 14, since the guide end of the inner edge portion 38 whose inner diameter decreases toward the base end is guided by the guide action of the inner edge portion 38, the base end portion 43 of the guide wire 42 is not caught by the stepped portion 30. End 43 is preferably guided into hub lumen 24. Thereby, the base end part 43 of the guide wire 42 can be smoothly moved in the base end direction in the hub 14.

In the present embodiment, the base end surface 12 a of the shaft 12 is in contact with the tip 30 a of the stepped portion 30 provided on the hub 14. With this configuration, the base end portion 43 of the guide wire 42 does not enter between the base end portion 32 of the shaft 12 and the stepped portion 30, and the base end portion 43 of the guide wire 42 is more smoothly baseed in the hub 14. It can be moved in the end direction.

In particular, as shown in FIG. 3A, in this embodiment, the inner edge portion 38 provided on the hub 14 has an arcuate shape in the longitudinal section of the hub 14 (curved so as to rise toward the inside of the hub 14. Shape). According to this configuration, the contact between the most proximal end portion 44 (see FIG. 4B) of the guide wire 42 and the inner edge portion 38 is close to a point contact, and the contact area is reduced, whereby the most proximal end portion of the guide wire 42 is obtained. The frictional resistance between 44 and the inner edge 38 can be reduced. For this reason, when the proximal end portion 43 of the guide wire 42 is moved in the proximal direction within the hub 14, the proximal end portion 43 of the guide wire 42 easily passes through the stepped portion 30.

On the other hand, as shown in FIG. 3B, even when the inner edge portion 39 that is linear in the longitudinal section of the hub 14 is provided, the proximal end portion 43 of the guide wire 42 is formed by the inner edge portion 39 that is inclined linearly. Since the guide is smoothly guided to the axis a side of the hub 14, the base end portion 43 is not caught by the stepped portion 30, and the base end portion 43 of the guide wire 42 is easily moved in the base end direction within the hub 14. Can be made.

In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims

A catheter (10) comprising a shaft (12) constituting a catheter body and a hub (14) provided at a proximal end of the shaft (12),
The hub (14) includes a shaft holding portion (28) for holding the proximal end of the shaft (12), and a lumen ( A hub lumen forming portion (34) forming a hub lumen (24) in communication with 13),
The hub lumen forming part (34) is provided on the proximal side with respect to the shaft holding part (28) through a step part (30) having a diameter reduced with respect to the shaft holding part (28),
The step portion (30) has inner edge portions (38, 39) whose inner diameter decreases toward the proximal direction.
A catheter (10) characterized in that.
Catheter (10) according to claim 1,
The base end of the shaft (12) is in contact with the step portion (30) provided in the hub (14).
A catheter (10) characterized in that.
The catheter (10) according to claim 1 or 2,
The inner edge portion (38) provided in the hub (14) has a shape curved in an arc shape in a longitudinal section of the hub (14).
A catheter (10) characterized in that.
The catheter (10) according to claim 1 or 2,
The inner edge portion (39) provided on the hub (14) has a linear shape in a longitudinal section of the hub (14).
A catheter (10) characterized in that.