JP6985208B2 - How to manufacture a balloon catheter with a rod-shaped core inserted - Google Patents

Description

The present invention relates to a method for manufacturing a balloon catheter in which a rod-shaped core material is inserted, in which a rod-shaped core material is inserted into a guide wire lumen of the balloon catheter in which a protective tube is covered with a balloon.

A general balloon catheter has a tubular member extending from the proximal side to the distal side, an opening for introducing fluid on the proximal side, and a balloon that expands in the circumferential direction on the distal side of the balloon catheter. The tubular member includes a guide wire lumen extending from the proximal side to the distal side and a lumen leading to the balloon from the proximal side to the distal side.

In the balloon catheter manufacturing process, a protective tube 2 is covered to protect the balloon site as shown in FIG. 1a. In order to sufficiently protect the distal portion of the balloon catheter, the distal end of the protective tube is located distal to the distal end 4 of the balloon catheter.

Since the tube portion of the balloon catheter is made of a highly flexible resin, a rod-shaped core material is passed through the lumen of the balloon catheter in order to maintain its shape. As shown in FIG. 1b, the rod-shaped core material 3 is generally longer than the total length of the balloon and is inserted into the guide wire lumen 5 from the distal end 4 of the balloon catheter. The rod-shaped core material 3 has a shape that can be inserted into the guide wire lumen 5. The rod-shaped core material 3 may have a head (large diameter portion) (not shown) having a size larger than the inner diameter of the protective tube 2 on the side opposite to the side to be inserted into the distal end 4 of the balloon catheter. The head serves as a stopper so that the rod-shaped core material 3 does not go too far toward the proximal end side of the guide wire lumen 5. The rod-shaped core material 3 is inserted until the head of the rod-shaped core material 3 comes into contact with the distal end of the protective tube 2 that protects the balloon portion.

In the process of manufacturing a balloon catheter, if the protective tube is not transparent, first pass the rod-shaped core material through the balloon protective tube, then insert the rod-shaped core material into the distal end of the balloon catheter, and slide the balloon protective tube into the balloon. By covering the balloon catheter with a protective tube and a rod-shaped core material. Also, when the balloon is covered with the balloon protective tube first, if the protective tube is opaque, even if you try to insert the rod-shaped core material into the balloon after covering the protective tube, the distal end of the balloon catheter cannot be seen and it is inserted. Difficult to do. Furthermore, since the position of the center of the guide wire lumen at the distal end of the balloon catheter does not always coincide with the center of the balloon protective tube, the balloon catheter can be inserted even if the rod-shaped core material is inserted so as to coincide with the center of the protective tube as shown in FIG. 1c. May not fit into the distal end of the balloon.

Patent Document 1 describes a jig for forcibly centering an inner tube and inserting a rod-shaped core material by using a guide mechanism in a tube of an inner / outer double tube.

Japanese Unexamined Patent Publication No. 2018-15833

When the jig described in Patent Document 1 is used, the step of inserting the jig into the outer tube is once performed, but the tube diameter is as small as millimeter to submillimeter, and the jig having a size close to the inner diameter of the outer tube is once inserted into the outer tube. Workability is not good because it is necessary to do.

In view of the above-mentioned problems, an object of the present invention is to provide a method for simply inserting a rod-shaped core material into a guide wire lumen of a balloon catheter in which a balloon is covered with a protective tube.

That is, the present invention
(1). A method for manufacturing a balloon catheter in which a protective tube is covered on a balloon and a rod-shaped core material is inserted into a guide wire lumen.
By inserting a needle-shaped instrument between the distal end or distal part of the balloon catheter and the protective tube, the distal end of the balloon catheter is brought into contact with the inner wall of the protective tube, and the rod-shaped core material is in contact with the inner wall of the protective tube. How to make a balloon catheter with a rod-shaped core inserted into the guide wire lumen,
(2). The method for manufacturing a balloon catheter into which a rod-shaped core material is inserted according to (1), wherein the tip of the needle-shaped instrument is tapered.
(3). The method for manufacturing a balloon catheter into which a rod-shaped core material is inserted according to claim 1 or 2, wherein when the rod-shaped core material is inserted into the guide wire lumen, the rod-shaped core material is inserted along the needle-shaped instrument.
Regarding.

Using the method of the present invention, the rod-shaped core material can be easily inserted into the guide wire lumen of the balloon catheter in which the balloon is covered with a protective tube.

It is a figure showing a part of a balloon catheter and a part of a rod-shaped core material. It is a figure which shows the form which inserted the rod-shaped core material into a balloon catheter. It is a figure showing the form which the rod-shaped core material was mistakenly inserted between a balloon catheter and a protective tube. It is sectional drawing of AA in FIG. 1a. Represents a balloon catheter and a needle-like instrument. It is a figure which shows the form which inserted the needle-like instrument into the protective tube and the distal part of a balloon catheter. FIG. 2b is a diagram showing a form in which the needle-shaped instrument is tilted in the longitudinal direction and the distal portion of the balloon catheter is lifted after FIG. 2b. FIG. 2C is a cross-sectional view taken along the line BB in FIG. 2c. It is a figure which inserts the rod-shaped core material along the needle-shaped instrument in the state of FIG. 2c. It is a figure which inserted the rod-shaped core material into the guide wire lumen by using the instrument of this invention.

Hereinafter, embodiments of the apparatus according to the present invention will be described with reference to the drawings. For convenience, the reference numerals may be omitted in the drawings, but in such cases, other drawings will be referred to. Further, the dimensions of various members in the drawings may be adjusted for convenience and to be easily seen.

<First embodiment>
In the figure, the balloon catheter has balloons arranged in tubes so as to be concentric circles, but the present invention is not particularly limited, and the center of the balloon and the tube may be offset. For example, the balloon may have a biased shape in which the balloon is arranged only in a part of the circumferential direction of the tube, or the shape of the balloon itself may be biased with respect to the circumferential direction. Regarding the shape of the balloon, the picture describes a balloon having a cone shape at both ends and a straight shape at the center, but it is not particularly limited. A shape in which a plurality of balloons are connected in the axial direction, such as an expansion suppressing portion being arranged in the portion, may be used. Further, the folding shape of the balloon is not particularly limited, and it may be folded in two, in three, or in a plurality of four or more.

The purpose of the protective tube is to protect the balloon with the protective tube, but since it is subsequently stored in a tube that protects the entire catheter, a resin having a hardness higher than that of the balloon is preferable. The resin is not particularly limited to polyethylene, polypropylene, nylon, fluororesin and the like. The shape of the protective tube is not particularly limited, and may be a simple cylindrical shape, a spirally bulging shape, or a bone shape. The length of the protective tube is preferably 20 mm or more and 350 mm or less, and more preferably 50 mm or more and 250 mm or less. The protective tube is preferably 5 mm or more longer than the balloon, and more preferably 10 mm or more so as to sufficiently cover the balloon.
The shape of the rod-shaped core material is not particularly limited, and the diameter may be constant in the longitudinal direction, or the diameter may decrease toward the tip side. Further, as the material of the rod-shaped core material, a metal having little deformation and no deterioration is preferable. The diameter of the rod-shaped core material is 0.3 mm or more and 1 mm or less. The length of the rod-shaped core material is preferably 100 mm or more. The diameter of the rod-shaped core material is 0.2 mm or more and 1 mm or less. The diameter of the rod-shaped core material is preferably 0.1 mm or more smaller than the diameter of the guide wire lumen.

The shape of the head of the rod-shaped core material is preferably rounded, and R0.5 mm or more is preferable.

FIG. 2a illustrates a form in which the needle-shaped instrument 11 is inserted into the distal end 4 of the balloon catheter covered with the protective tube and the protective tube 2.

FIG. 2a shows a needle-shaped instrument 11 having a simple linear taper shape at the tip, but the tip shape is not particularly limited, and a uniform cross-sectional shape may be used, but the distal end 4 of the balloon catheter is shown. It is preferably a straight line or a curved taper shape so that it can be easily lifted. The taper angle is preferably 1 ° or more. The cross-sectional shape of the needle-shaped device 11 is not particularly limited to a circular shape, an elliptical shape, a quadrangle shape, a crescent shape, or a horseshoe shape, but the needle-shaped device 11 is rounded so as not to damage the protective tube 2 and the balloon catheter 1 when the needle-shaped device 11 is inserted. It is preferable that the shape is different. The material of the needle-shaped instrument 11 is not particularly limited to metal or resin, and the surface condition is preferably a mirror finish so that the protective tube 2 and the balloon catheter 1 are not damaged when the needle-shaped instrument 11 is inserted. The outer diameter of the needle-shaped instrument 11 is not particularly limited, but it must enter the gap formed by the outer surface of the distal end 4 of the balloon catheter and the inner surface of the protective tube 2, and must be 0.2 mm or more and 1.0 mm or less. Is preferable. The length of the needle-shaped instrument 11 is preferably 100 mm or more.

After the arrangement of FIG. 2a, as shown in FIG. 2b, by further inserting the needle-shaped instrument 11 toward the proximal side of the balloon catheter 1, the distal end 4 of the balloon catheter is lifted upward and comes into contact with the inner wall of the protective tube 2. .. In the state of the balloon catheter 1, the protective tube 2, and the needle-shaped device 11, for example, when the needle-shaped device 11 has a small cross section, a gap is generated by simply inserting the needle-shaped device 11 as shown in FIG. 2b. Since the distal end 4 of the catheter may not come into contact with the inner wall of the protective tube 2, by tilting the tip of the needle-like device 11 radially inward to lift the distal end 4 of the balloon catheter, as shown in FIG. 2c. , The distal end 4 of the catheter can be brought into contact with the inner wall of the protective tube 2 as shown in FIG. 2d.

In FIG. 2b or FIG. 2c, the position of the guide wire lumen is uniquely determined when the distal end 4 of the balloon catheter is in contact with the inner wall of the protective tube 2. Therefore, by advancing the rod-shaped core material 3 along the needle-shaped instrument 11 as shown in FIG. 2e, the rod-shaped core material 3 can be easily inserted into the guide wire lumen 5 as shown in FIG. 2f.
Once the tip of the rod-shaped core material 3 has entered the guide wire lumen 5, the rod-shaped core material 3 can be advanced in the insertion direction. If the distal end 4 of the balloon catheter is lifted by the needle-shaped instrument 11, resistance may occur to the insertion of the rod-shaped core material 3 due to the deformation of the shape in the guide wire lumen. Therefore, the needle-shaped instrument 11 is temporarily removed before proceeding with the insertion of the rod-shaped core material 3 in order to reduce the insertion resistance.

1 Balloon catheter 2 Protective tube 3 Rod-shaped core material 4 Balloon catheter distal end 5 Guide wire lumen 11 Needle-shaped instrument

Claims (4)

A method for manufacturing a balloon catheter in which a protective tube is covered on a balloon and a rod-shaped core material is inserted into a guide wire lumen.
By inserting a needle-shaped instrument between the distal end or distal part of the balloon catheter and the protective tube, the distal end of the balloon catheter is brought into contact with the inner wall of the protective tube, and the rod-shaped core material is in contact with the inner wall of the protective tube. A method for manufacturing a balloon catheter into which a rod-shaped core material is inserted, which is inserted into a guide wire lumen. The method for manufacturing a balloon catheter into which a rod-shaped core material is inserted, wherein the tip of the needle-shaped instrument is tapered. The method for manufacturing a balloon catheter into which a rod-shaped core material is inserted, wherein the rod-shaped core material is inserted along the needle-shaped instrument when the rod-shaped core material is inserted into the guide wire lumen. The balloon into which the rod-shaped core material according to any one of claims 1 to 3 is inserted, wherein the distal end of the balloon catheter is brought into contact with the inner wall of the protective tube by tilting the tip of the inserted needle-shaped device inward in the radial direction. How to make a catheter.

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