JPS5980258A - Cathetel and production thereof - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] ■ Storage of inventions Technical field The present invention relates to a catheter and a method for manufacturing the same.

BACKGROUND OF THE INVENTION A catheter 1 as shown in FIG. 1 is inserted into a body cavity such as a blood vessel without being guided by, for example, a kite wire, and the direction of its tip is controlled so that it can reach five target sites.

Therefore, this catheter 1 is required to have a certain degree of torsional rigidity so that the distal end 3 can be oriented by twisting the base of the main body 2. In addition, it is possible to easily give the distal end 3 a shape that allows easy insertion into the target site, and the distal end 3 is easily deformed along the insertion route change of the blood vessel etc. during insertion, thereby preventing damage to the inner wall of the blood vessel etc. The tip portion 3 is required to have flexibility so as not to cause any damage.

@2 is a partially cutaway view showing a conventional catheter 4 having flexibility at the distal end and moderate torsional rigidity. The catheter 4 has a wire layer 7 interposed between a flexible inner tube section 5 and a flexible outer tube section 6 to form a torsionally rigid main body section 8. Further, this catheter 4 has a relatively flexible tip portion 9 connected to the end portion of the main body portion 8 from which a portion of the outer tube portion 6 is removed.

However, in the catheter 4, the main body 8
A step is created at the connection between the tip and the distal end 9, making it difficult to insert into a blood vessel or the like in the circle M, and there is a risk of thrombus formation. Further, due to a poor connection between the main body portion 8 and the tip portion 9, there is a possibility that the two may come apart.

FIG. 3 is a partially cutaway view of another conventional catheter 10 having flexibility at the distal end and moderate torsional rigidity. This catheter 10 has a flexible outer inner tube section 11
A first wire layer 12 is formed from the proximal end to the front end of the wire,
Fold back from the front of the tip and extend the second section from 114'I to the base end.
After the wire layer 13 is formed, a flexible outer tube section 14 is coated on the upper surface of the inner tube section 11 and both wire layers 12,13.

However, in the catheter 10, a reinforcing layer consisting of two layers, a first wire layer 12 and a second wire layer 13, is interposed between the inner tube section 11 and the outer tube section 14 constituting the main body. Therefore, the reinforcement layer Q)@Jy-mi becomes large,
The inner diameter of the catheter becomes small below a predetermined outer diameter of the catheter determined by the inner diameter of the containment path of the blood vessel or the like into which the catheter is inserted. In addition, since the thickness of the reinforcing layer is approximately the same, there is a relatively thick step between the outer diameter of the catheter at the main body and the outer diameter at the tip, making it difficult to insert the catheter into a blood vessel. Become. In addition, since the catheter 10 is formed by turning the first wire layer 12 and the second wire layer 13 on the upper surface of the inner tube part 11 constituting the main body part, the whole is formed continuously. However, it is not possible to obtain a base material for a catheter.

■Object of the Invention The first aspect of the present invention is that the main body and the tip are integrally formed, the torsional rigidity is high, the tip has flexibility, and the outer diameters of the main body and the tip are approximately equal. The object of the present invention is to provide a catheter that can be formed with a relatively large inner diameter.

In addition, the second aspect of the present invention is that the resting part and the distal end are integrally formed, the torsional rigidity is high, the distal end has flexibility, and the outer diameters of the main body and the distal end are approximately equalized, and compared to It is an object of the present invention to provide a manufacturing method that can continuously form a catheter that can have a large internal diameter.

■Structure of the Invention In order to achieve the above object, the present invention provides a catheter in which a main body portion having relatively thick torsional rigidity and a distal end portion having relatively low torsional rigidity are integrally formed in the axial direction. A single reinforcing layer is interposed between the flexible inner tube and the flexible outer tube in the main body.

Further, in the catheter according to the present invention, the reinforcing layer is composed of a densely woven wire layer on the side opposite to the distal end of the main body and a loosely woven wire layer on the distal end side of the main body. This is what I did.

Further, in the catheter according to the present invention, the reinforcing layer is composed of a woven wire layer on the side opposite to the distal end in the resting part and a non-woven wire layer on the distal end side in the main body part. .

Further, in the catheter according to the present invention, the end portion of the reinforcing layer on the distal end side is bonded to the inner tube portion.

In addition, the present invention provides four body parts with relatively thick torsional rigidity,
In a method for manufacturing a catheter in which a distal end portion having relatively low torsional rigidity is integrally formed in the axial direction, a flexible inner tube portion is extruded and a predetermined interval is formed on the upper surface of the inner tube portion. a flexible outer tube part is extruded on the upper surface of the inner tube part and the reinforcing layer, and a flexible outer tube part is formed by extrusion forming the inner tube part and the upper surface of the reinforcing layer. It is designed so that the section can be cut off.

Further, in the method for manufacturing a catheter according to the present invention, the reinforcing layer NI is formed by continuously forming a wire layer on the upper surface of the inner tube portion, and then using the remaining wire layer after removing a part of the wire layer. This is what I did.

Further, in the method for manufacturing a catheter according to the present invention, the reinforcing layer is formed by continuously forming a densely woven wire layer and a loosely woven wire layer on the upper surface of the inner tube portion, and then forming the reinforcing layer on the upper surface of the inner tube portion. The remaining wire layer is formed by removing approximately the central portion of the wire layer.

Further, in the method for manufacturing a catheter according to the present invention, after forming the reinforcing layer in a continuous manner as a woven wire layer and a non-woven wire layer on the upper surface of the inner tube part, The wire layer is formed by removing the central portion and remaining the wire layer.

Further, in the method for manufacturing a catheter according to the present invention, both ends of the reinforcing layer are bonded to the inner tube portion.

■Detailed description of the invention FIG. 4 (5) shows a catheter 2 according to the first embodiment of the invention.
0, FIG. 4 (Bl is a plan view showing a part of the outer tube part of the catheter 20 peeled off, and FIGS. 5(A) and (13) are plan views showing the manufacturing process of the catheter 20. It is a diagram.

Catheter 20Lt, FIG. 4 (- and (B)
The tip portion 22 has a relatively small torsional rigidity with a length L2 and a length L2.
are integrally formed in the axial direction. That is, in the catheter 20, a single-layer reinforcing layer 25 is interposed between the flexible inner tube section 23 and the flexible outer tube section 24 in the main body section 21, and the distal end section 22 is formed by an integrated state of an inner tube portion 23 and an outer tube portion 24. The reinforcing layer 25 is made of a wire layer knitted in a predetermined manner, and is bonded to the end portion (4) of the reinforcing layer 25 on the distal end 22 side (4) to the inner tube portion 23. 24 is made of flexible plastic such as polyurethane elastomer, polyamide elastomer, polyester elastomer, polyethylene, etc., and the reinforcing layer 25 is made of stainless steel wire. , an opening 26 as shown by the two-dot chain line in FIG. 4(5).
may be provided on its side.

The catheter 20 has a main body part 21 and a tip part 2.
2 are integrated, so there is no risk of them coming apart due to poor connection, etc. Also, since the main body part 21 has a reinforcing layer 25 and the tip part 22 does not have a reinforcing layer, it has high torsional rigidity. In addition, it becomes possible to provide flexibility to the tip. In addition, since the reinforcing layer 25 is formed from one layer, its thickness is small, and the inner diameter of the catheter can be set to within a predetermined outer diameter of the catheter determined by the inner diameter of the insertion path of the blood vessel or the like into which the catheter is inserted. In addition, there is almost no difference in level between the catheter outer diameter of the main body part 21 and the catheter outer diameter of the distal end part 22, making it possible to smoothly insert the catheter into a blood vessel or the like.

Next, a method for manufacturing the catheter 20 will be described. First, the flexible inner tube portion 23 is extruded. Next, a reinforcing layer 25 consisting of a single layer knitted at a predetermined pitch is formed on the inner tube portion 23, as shown in FIG. 5(5). Next, both ends of the reinforcing layer 25 in a certain section to be removed are adhered to the inner tube part 23 with adhesive to prevent it from peeling off from the inner tube part 23, and then a part of the reinforcing layer 25 is removed as shown in FIG. ζ as shown in (B)
ζRemove. Next, a flexible outer tube section 24 is extruded onto the upper surface of the inner tube section 23 and the reinforcing layer 25. Next, cut approximately the middle part X1 of the part with the reinforcing layer 25 and the part X2 of the part without the reinforcing layer 25, insert the part with the reinforcing layer 25 into the main body part 21, and cut the part where the reinforcing layer 25 is not there. first; 4th part 2
2 is obtained. In addition, the catheter is
The tip portion 22 is molded into a shape of 11 and ready for use. That is, according to the manufacturing method described in E, the catheter 20 can be formed continuously.

FIG. 6 (A(4) Catheter 3 according to the second embodiment of the present invention
6(B) is a plan view showing a part of the outer tube part of the same catheter 30 after being peeled off, and FIG. 7(A+) is a plan view showing the manufacturing process of the same catheter 30. It is 1.

As shown in FIG. 6 and ff3+, the catheter 30 has a main body portion 31 having a length Ll and relatively thick torsional rigidity, and a distal end portion 32 having a length L2 and relatively low torsional rigidity in the axial direction. In the catheter 30 which is integrally formed, a reinforcing layer consisting of a single layer is provided between the flexible inner tube portion 33 and the flexible outer tube portion 34 in the first body portion 31. 35
is inserted, and the distal end portion 32 is formed by an integrated state of an inner tube portion 33 and an outer tube portion 34. Here, the reinforcing layer 35 (c) A densely woven wire layer 35A at the anti-light end portion 32 of the main body 31 and a loosely woven wire layer 35B at the tip 32 of the main body 31. The tip 32 of the wire layer 35B (IIl
The end of i is glued to the inner tube part 33.

- In the catheter 30 described above, the main body 31 and the distal end 32 are integrally formed like the catheter 20, and the main body 31 and the distal end 32 have high torsional rigidity and flexibility. This makes it possible to substantially equalize the outer diameter and form a relatively thick inner diameter. In particular, in the upper M+2 catheter 30, the densely woven wire layer 35A on the anti-light Zln portion 32 side of the main body portion 31;
Since the reinforcing layer 35 is formed by the loosely knitted wire layer 35B of the distal end portion 321111 of the main body portion 31, the torsional rigidity of the distal end portion 32 of the main body portion 31, J: changes gradually. By increasing the responsiveness of the distal end portion 32 to the rotation of the catheter, it is possible to prevent the distal end portion 32 from abruptly bending relative to the main body portion 31, and to prevent the occurrence of occlusion of the internal space of the catheter due to the bending.

Next, a method for manufacturing the -F distribution data 30 will be explained. First, the flexible inner tube portion 33 is extruded. Next, a single layer of reinforcing layer 35 is continuously formed on the upper surface of the inner tube portion 33 as shown in FIG. 7(A).

Here, the reinforcing layer 35 has a dense mesh (for example, a pitch i).
H = 1 mm) wire layer 35A and a coarse mesh (H = 1 mm) wire layer 35A
For example, wire layers 35B with a pitch P2=10 nrm) are formed alternately. Next, after bonding the end portion of the wire layer 35B of a certain section to be removed to the inner tube portion 33 with an adhesive, a part of the approximately central portion of the wire layer 35B is removed as shown in No. 7M (13). . Next, the inner tube part 33, the wire layer 35A
, 35B, and the flexible outer tube portion 34 is extruded. Next, the wire layer 35A is cut at approximately the middle part X3 of g1H and the part where there is no reinforcing layer 35 is cut at the approximately middle part X2. A catheter 30 is prepared in which the portion without 35 is the distal end portion 32. In other words, according to the above, the catheter 30 can be formed continuously. Figure 8 is a plan view showing a catheter 40 according to a third embodiment of the present invention. 8.03) is a plan view showing a part of the outer tube portion of the same catheter 40 after being peeled off, and FIG. 9 (Al and (B)
2 is a plan view showing the manufacturing process of the same catheter 40. FIG.

As shown in FIG. 8 (A+ and (T3)), the catheter 40 has a main body portion 4 having a length Ll and relatively thick torsional rigidity.
1, and a tip portion 4 having a length of 1 to 2 and having relatively low torsional rigidity.
2 are integrally formed in the axial direction. The above catheter 4
0 (1, flexible inner tube part 4 that goes down to the main body part 41
A reinforcing layer 45 consisting of a single layer is interposed between the 3♂ flexible outer tube portion 44, and the tip portion 4'14' is formed by the integrated state of the inner tube portion 43 (!: outer tube portion 44). Here, the reinforcing layer 45 is formed from a braided wire layer 45A on the side of the end portion 42 opposite to the light in the main body portion 41, and a non-braided wire layer 45B on the side of the tip portion 42 in the main body portion 41ζ. ing.

The end portion of the wire layer 45B on the distal end portion 42 side is adhered to the inner tube portion 43.

Like the catheter 20, the catheter 40 has a main body 41 and a distal end 42 that are integrally formed, and has high torsional rigidity and flexibility at the distal end 42.
When the outer diameters of 1 and the tip 42 are equalized by cl,
It becomes possible to form a relatively thick inner diameter. Also,
The catheter 4064, the catheter 30 (!: Similarly, the main body portion 41.J: The torsional rigidity of the distal end portion 42 is made to have a gentle change, and the responsiveness of the distal end portion 42 to the rotation of the main body portion 41 is increased. This makes it possible to prevent the distal end portion 42 from bending sharply with respect to the main body portion 41.

Next, a method of manufacturing the catheter 40 will be explained. First, the flexible inner tube section 43 is extruded. Next, a reinforcing layer 45 is continuously formed on the inner tube portion 43 as shown in FIG. 9(5).

Here, the reinforcing layer 45 (4 knitted wire layers 45A and unknitted wire layers 45B are formed alternately).

Next, after adhering the end gB of the wire layer 45B of a certain section to be removed to the inner tube part 43 with an adhesive, a part of the approximately central part of the wire layer 45B is removed as shown in FIG. 9(]3). Remove this. Next, the inner tube'@B 43 and the wire layer 45A.

The outer tube portion 44 is extruded onto the upper surface of the tube 45B. Next, a substantially intermediate portion X1 of a certain portion of the wire layer 45A and the reinforcing layer 45
Cut at approximately the middle part X2 of the part without the wire I! 445
A catheter 40 is obtained in which the portions A and 45B are the main body portion 41 and the portion without the reinforcing layer 45 is the distal end portion 42. That is, according to the manufacturing method 5 described above, the catheter 40 can be formed in a coupled manner.

■Specific effects of the invention As described above, the present invention has a main body portion having a relatively thick torsional rigidity and a tip portion having a relatively small torsional rigidity.
In a catheter formed integrally in the force direction, between the flexible inner tube part and the flexible outer tube part in the main body part ζζ,
Since the reinforcing layer consisting of one layer is interposed between the main body and the tip 1 (11), the main body and the tip 1 (11) are integrally formed, and have high torsional rigidity and flexibility at the tip. It is possible to substantially equalize the inner diameter and form a relatively thick inner diameter.

In addition, in the catheter according to the present invention, the reinforcement Jv; By using a combination of 7 and 7, the torsional stiffness of the main body, lX, and the tip can be gradually changed, and the response of the tip to the rotation of the main body can be made faster.
This makes it possible to prevent the tip from bending sharply with respect to the main body.

Further, in the catheter according to the present invention, the reinforcing layer is composed of a woven wire layer on the side opposite to the distal end of the main body and a non-woven wire layer on the distal end side of the main body. , the change in torsional rigidity between the main body and the tip is made relatively gradual, thereby increasing the responsiveness of the tip to rotation of the main body and preventing sudden bending of the tip against the main body. becomes possible.

Further, in the catheter according to the present invention, the distal end of the reinforcing layer is bonded to the inner tube, thereby preventing the end of the reinforcing layer from peeling off from the inner tube during the crushing stage. It becomes possible to prevent this.

Further, the present invention provides a main body 71 (with a relatively thick torsional rigidity).
and a distal end portion with relatively low torsional rigidity are integrally formed in the 5 directions of the J-drawing (Here, h) A flexible inner tube 811 is extruded and A reinforcing layer is formed at a predetermined interval on the upper surface of the tube portion, a flexible outer tube portion is extruded on the upper surface of the inner tube portion and the reinforcing layer, and approximately in the middle of the portion where the reinforcing layer is located. and cut approximately the middle of the part without the core reinforcing layer.
l! A, it is possible to continuously form a catheter that can form a relatively thick inner diameter even when the outer diameters of the main body and the distal end are approximately equalized.

Further, in the method for manufacturing a catheter according to the present invention, the reinforcing layer is formed by continuously forming wire layers on two surfaces of the inner tube portion, and then forming the remaining Vi11 wire layer by removing a part of the core wire layer. By doing so, it becomes possible to continuously form a long base material for a catheter.

In addition, in the method for manufacturing a catheter according to the present invention, the reinforcing layer is formed by continuously forming a densely woven wire layer on the upper surface of the inner tube portion, and then forming the coarsely woven wire layer. By removing approximately the center of the wire layer and forming the remaining wire layer, the change in torsional rigidity between the main body and the tip is gradual, and the responsiveness of the tip to the rotation of the main body is improved. It is possible to continuously form a catheter that is fast and can prevent the tip from bending sharply with respect to the main body.

Further, in the method for manufacturing a catheter according to the present invention, after forming the reinforcing layer in a continuous manner as a woven wire layer and a non-woven wire layer on the upper surface of the inner tube part, By forming the remaining wire layer with the approximately central portion removed, the change in torsional rigidity of the upper tip of the body is relatively gradual and the responsiveness of the tip to rotation of the body is improved. If the speed is increased, it becomes possible to continuously form a catheter that can prevent a sharp bending of the distal end portion appearing in the main body portion.

In addition, the method for manufacturing a catheter according to the present invention includes bonding both ends of the reinforcing layer M to the inner tube part.
It is possible to extrude and mold the outer tube part on the upper surface of the reinforcing layer while preventing the reinforcing layer from peeling off from the inner tube part.

[Brief explanation of the drawing]

Fig. 1 is a plan view showing a general catheter, Fig. 2 is a partially cutaway view showing a catheter according to a conventional example, Fig. 3 is a partially cutaway view showing a catheter according to another conventional example, and Fig. 4 ( 5)
is a plan view showing a catheter according to a first embodiment of the present invention,
Fig. 4 (■3) is a plan view showing a part of the outer tube part of the catheter peeled off, Fig. 5 (5) and (E31) is a plan view showing the manufacturing process of the catheter, Al i
g of the present invention! ti, a plan view showing the catheter according to the second embodiment, FIG. 6 (■1) is a plan view showing a part of the outer tube part of the same catheter as ψ1A, FIG. 7 fA) and (13)
Figure 8 is a plan view showing the manufacturing process of the same catheter.
! i A plan view showing a catheter according to a third embodiment of the present invention, FIG. 13) is a flat diagram showing the manufacturing process of the same catheter. 20.30.40 Catheter, 21.31.41 Main body, 22.32.42 - Tip part, 23.33.43 - Inside also.・Part, 24.34.44 Outer pipe part, 25.35.45 Reinforcement layer, 35A, 35B, 45A, 45B Wire layer. Patent applicant: Chiru Seven Co., Ltd. Agent Patent attorney: Osamu Shiokawa Figure 1, Figure 2 Figure 3 Figure 0

Claims (1)

[Scope of Claims] (1) A catheter in which a main body portion having relatively high torsional rigidity and a distal end portion having relatively low torsional rigidity are integrally formed in the axial direction. A catheter characterized in that a reinforcing layer consisting of a single layer is interposed between an inner tube portion and a flexible outer tube portion. (2) The reinforcing layer iii consists of a densely woven wire layer on the side opposite to the tip of the main body and the tip 1 of the main body.
A catheter as set forth in claim 1, comprising a layer of wire braided at the base of the cutting side. 3) The catheter according to claim 1, wherein the reinforcing layer comprises a braided wire layer on the side opposite to the distal end of the main body and a non-braided wire layer on the distal end side of the main body. (4) The catheter according to any one of claims 1 to 3, wherein the end of the reinforcing layer on the distal end side is attached to the inner tube. (5) A catheter in which a main body portion having relatively high torsional rigidity f, f and a distal end portion having relatively low torsional rigidity are integrally formed in the axial direction. A reinforcing layer is formed on the upper surface of the inner tube portion at rotational intervals, a flexible outer tube portion is extruded and molded on the upper surface of the inner tube portion and the reinforcing layer, and the outer tube portion is extruded. A method for manufacturing a catheter, the method comprising cutting approximately the middle part of the reinforcing layer and the approximately middle part of the part without the reinforcing layer. (6) The catheter according to claim 5, wherein the reinforcing layer is formed by continuously forming a wire layer on the upper surface of the inner tube portion, and then removing a portion of the wire layer to form the remaining wire layer. Method 0 (7) The reinforcing layer is formed by continuously forming a densely woven wire layer and a coarsely woven wire layer on the upper surface of the inner tube part, and then 7. The method of manufacturing a catheter according to claim 6, wherein the wire layer is formed by removing a substantially central portion of the wire layer and forming the remaining wire layer. (8) The reinforcing layer fYJ is made by continuously forming a woven wire layer and a non-woven wire layer on the upper surface of the inner tube portion, and then removing the approximately central portion of the non-woven wire layer. 7. A method of manufacturing a catheter according to claim 6, wherein the catheter is formed of layers. (9) The method for manufacturing a catheter according to any one of claims 5 to 8j, wherein the reinforcing layer is formed by bonding both sides thereof to the inner tube H1i.