JP2505954B2 - Medical tube and method of manufacturing the same - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical tube and a method for manufacturing the same, and more particularly to uniforming the dimensional accuracy in the length direction to improve pressure resistance and buckling resistance, and to improve the surface of the inner hole. The present invention relates to a medical tube for smoothing and preventing damage to the boundary between a plurality of inner holes, and a manufacturing method thereof.

[0002]

2. Description of the Related Art As a medical tube, for example, there is a multi-lumen tube used for a cardiac catheter or the like.

This multi-lumen tube is, for example,
It is inserted from the elbow vein using a guide wire, and the tip is inserted into the atrium, ventricle, and pulmonary artery of the heart via the femoral artery while observing with an X-ray. By inserting such a multi-lumen tube, the blood pressure at these various sites is measured by a pressure sensor at the tip, injection of a contrast agent or the like, or blood sample collection is performed, or the indication for cardiac surgery is determined. Other measurements (measurement of oxygen content, etc.) and treatments can be performed.

Therefore, as characteristics of the multi-lumen tube, (1) it has a pressure resistance enough to withstand one-shot injection of a contrast agent, etc. (2) resistance that the inner hole is not blocked by twisting during insertion. Buckling, (3)
Guidance to a desired position and flexibility required for arranging the tip at a predetermined position are required.

In view of such demands, the conventional multi-lumen tube is formed of a thermoplastic resin as disclosed in, for example, Japanese Patent Laid-Open Nos. 63-212374 and 60-132570. A tube having a plurality of inner holes (lumens) formed therein, a reinforcing body made of a plurality of thin wires provided on the outer circumference of the tube, and a tube covering made of a thermoplastic plastic provided on the outer circumference of the reinforcing body. ing. In addition, as a manufacturing method thereof, generally, a thermoplastic resin is extruded to form a tube having a plurality of inner holes, and a mesh-like reinforcing body composed of fine wires such as metal or plastic is braided around the tube. It is formed by a machine, and further, a thermoplastic resin is extruded on the outer periphery of the tube to form a tube covering, which is continuously manufactured, and finally cut into a predetermined length to be a product. In addition, JP-A-60-13
As shown in Japanese Patent No. 2570, it is possible to discontinuously manufacture by a batch method.

[0006]

However, according to the conventional medical tubing, since a plurality of inner holes are formed in a single extruded material made of a thermoplastic, the present material characteristics, the extrusion molding temperature, and the like. In the manufacturing method based on the control of the extrusion discharge amount and the like, there is a limit in making the inner hole, wall thickness, etc. of the extruded material in the length direction uniform, and the extrusion pressure escapes to the inner hole. The surface of the hole has irregularities or roughness.
Inhomogeneity in dimensional accuracy in the length direction, especially when a thin wall portion occurs at the boundary between the inner holes, the boundary between the inner holes is deformed due to external force such as bending or bending, and the inner holes are deformed. May be crushed or blocked. Further, in the case where another measurement is performed while injecting the drug solution, the inner pressure may be deformed by the injection pressure, or the other inner hole may be blocked by the deformation. In the worst case, the boundary part may be destroyed and a plurality of inner holes may communicate with each other, thereby failing to function as a catheter. Further, if unevenness or roughness occurs on the surface of the inner hole, the guide wire is caught by the unevenness or roughness of the inner hole when the guide wire is inserted, and the boundary portion is damaged.

Therefore, an object of the present invention is to provide a medical tube capable of uniforming the dimensional accuracy in the length direction, particularly the wall thickness of the boundary portion between a plurality of inner holes, and a method for manufacturing the same. is there.

Another object of the present invention is to provide a medical tube capable of smoothing the surface of the inner hole and a method for producing the medical tube.

[0009]

In view of the above problems, the present invention can make the dimensional accuracy in the length direction uniform, particularly the thickness of the boundary portion between a plurality of inner holes, and smooth the surface of the inner holes. To have a tube having a predetermined inner diameter and a predetermined wall thickness,
An uneven thickness tube having at least one lumen having a predetermined inner diameter formed in a thick portion whose thickness continuously changes in the circumferential direction is provided, and the tube is embedded in the thick portion of the thick portion of the uneven thickness tube. It provides an inserted medical tube.

The uneven thickness tube has a reinforcing member on its outer periphery,
And a tube jacket, a tube, an uneven thickness tube,
The tube casing and the tube casing are fixed to each other in the length direction and integrated with each other.

In the above method for producing a medical tube, a tube having a predetermined wall thickness is formed by extrusion molding on the outer circumference of a core body having a predetermined outer diameter, and at least one lumen having a predetermined inner diameter is provided on the outer circumference of the tube. And by forming an eccentric thickness tube having a wall thickness portion in which the wall thickness is continuously changed in the circumferential direction by extrusion molding, and on the outer periphery of the eccentric wall tube, a braided portion in which a plurality of thin wires are braided The non-braided parts arranged in parallel are formed at a predetermined interval in the length direction, the thin wires of the non-braided part are removed, the ends of the thin wires of the braided part are fixed to the uneven thickness tube, and the outer circumference of the uneven thickness tube A tube jacket having a predetermined outer diameter is formed by extrusion molding, the whole body is cut at a substantially intermediate position of the non-braided portion, and a tensile force is applied to the core body to pull out the core body. There is.

Further, in order to achieve the above object, the present invention provides
It is intended to provide a medical tube including a plurality of tubes having a predetermined inner diameter and a predetermined wall thickness, and a tube covering body that arranges the plurality of tubes in parallel and covers the outer circumference thereof.

The tube covering body is provided with a reinforcing body and a tube jacket body on the outer periphery thereof.

In the above-mentioned medical tube manufacturing method, a plurality of tubes having a predetermined wall thickness are formed by extrusion molding on the outer circumferences of a plurality of core bodies having a predetermined outer diameter, and the plurality of tubes are made parallel to each other. While arranging and gathering, a tube covering is formed by extrusion so as to cover the outer circumference of a plurality of tubes, and the outer circumference of the tube covering is braided with a plurality of thin wires and a plurality of thin wires are arranged in parallel. Form the arranged non-braided portion at a predetermined interval in the length direction,
The thin wire of the non-braided part is removed, the end of the thin wire of the braided part is fixed to the tube covering, and a tube jacket having a predetermined outer diameter is formed on the outer periphery of the tube covering by extrusion molding. There is a step of cutting the whole of the braided portion at a substantially intermediate position and applying a tensile force to the core to pull out the core.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The medical tube of the present invention and the method for producing the same will be described below in detail with reference to the accompanying drawings.

1 (a), (b), and (c) show the cross-sectional structure of the multi-lumen tube of one embodiment of the present invention. This multi-lumen tube 1 has a tube 11 that forms a first lumen 10 and a tube 11 that is embedded in a large portion of a wall thickness portion where the wall thickness continuously changes in the circumferential direction. 12 includes an eccentric wall tube 13 forming a bulge 12, a reinforcing body 14 provided on the outer periphery of the eccentric wall tube 13, and a tube jacket 15 provided on the outer periphery of the eccentric wall tube 13 via the reinforcing body 14. There is.

The tube 11 has a thickness of 0.03 to 0.20.
It has a uniform thickness in the length direction, which is appropriately selected from the above range, and is made of olefin-based PE, PP, PET, polyamide-based polyamide resin, hard elastomer, polyurethane-based resin, or the like. In this embodiment, high density PE is applied in terms of moldability, dimensional stability, strength, etc., and the inner diameter is 0.5 mm and the outer diameter is 0.7 mm.

The uneven thickness tube 13 can be made of the same resin as the tube 11 or a different resin. In this embodiment, low-density PE is applied because of its moldability, dimensional stability, flexibility, etc.
To have a diameter of 0.4 mm and an outer diameter of 1.3 mm. The second lumen 12 is preferably formed as close to the outer circumference of the tube 11 as possible.

The reinforcing body 14 is formed by braiding fine wires such as metal or plastic having high rigidity. In this embodiment, a stainless wire of 0.04 mm to 0.06 mm is used and is formed at one end of the uneven thickness tube 13 with a predetermined length. Both ends of the braid are fixed to the outer peripheral portion of the uneven thickness tube 13, and the other end of the uneven thickness tube 13 has a portion where the reinforcing body 14 is not formed, as shown in FIG.

The tube jacket 15 is a tube 13 with uneven thickness.
It is made of the same low-density PE as the uneven thickness tube 13 so as to be closely adhered to and integrated with.

A method of manufacturing the multi-lumen tube will be described below with reference to FIG. First, the outer diameter is 0.
A tube 11 made of high-density PE is extrusion-molded on the outer periphery of the core body 20 having a diameter of 5 mm to cover the core body 20 with the tube 11 having an outer diameter of 0.7 mm. This core body 20 is used so as not to be affected as much as possible by changes in extrusion molding conditions, and reduces dimensional changes in the length direction such as the inner diameter, outer diameter, and wall thickness of the tube 11. The core 20 may be either a metal wire or a plastic wire, but it is preferable to use a metal wire because it needs to be removed before the finished product. In this embodiment, a copper wire is used from the viewpoint of core removal, and fluorine-based powder or silicon oil is applied to the surface of the copper wire for releasability.

Next, the outer diameter of the tube 11 is 0.4 m.
m core body 21 is abutted, and an uneven thickness tube 13 made of soft PE is extruded on the outer circumference of the tube 11 and the core body 21 to make the tube 11 and the core body 21 have an outer diameter of 1.3.
It is covered with an uneven thickness tube 13 of mm. Second lumen 1
When the dimensional accuracy of 2 is not required, the first lumen 1
The thickness of the boundary between 0 and the second lumen 12
The core body 21 may be omitted since it can be secured with the wall thickness.

Thereafter, a braided portion 14 in which a plurality of stainless wires having a diameter of 0.04 mm to 0.06 mm are braided and a non-braided portion 14 a in which the stainless steel wires are arranged in parallel are provided on the outer periphery of the uneven thickness tube 13. Form at intervals. Braid part 14
The length of the non-braided portion 14a is determined by the length of the tube used as a finished product. The non-braiding portion 14a can be formed by stopping the rotation of the braiding machine or by reducing the rotation and increasing the take-up or feeding speed of the uneven thickness tube 13.

Then, the stainless wire of the non-braided portion 14a is removed, and the stainless wire of the braided portion 14 is replaced with the uneven thickness tube 1
Fix to 3. The stainless steel wire is fixed by heating the outer periphery of the uneven thickness tube 13 with the heater heat through the uneven thickness tube 13 from which the non-braided portion 14a is removed through a die having a heater inside, and further squeezing with a die to reinforce the reinforcing body 14 Can be carried out by burying in the outer peripheral portion of the uneven thickness tube 13. At this time, since the core bodies 20 and 21 are respectively inserted into the first lumen 10 and the second lumen 12, the pressing force by the die can be directly applied to the braided body 14.

Further, the tube jacket 1 made of low-density PE is provided on the outer circumference of the uneven thickness tube 13 in which the reinforcing body 14 is embedded.
5 is formed by extrusion. At this time, if it is performed while heating the uneven thickness tube 13 at a predetermined temperature, the tube jacket 15 and the uneven thickness tube 13 can be easily fixed and integrated.

Finally, the whole body is cut at a substantially intermediate position where the reinforcing body 14 is not formed, and a tensile force is applied to the core bodies 20 and 21, so that the core bodies 20 and 21 are extracted and commercialized.

3 (a), (b) and (c) show a second embodiment of the present invention, and the same parts as (a), (b) and (c) of FIG. Since the same reference numerals and symbols have been given, redundant description will be omitted, but the second lumen 12 is formed by the second tube 16 that has been preformed, and the tube 11 and the second tube 16 are brought into contact with each other. , A tube covering 17 made of low-density PE on the outer circumference of the tube 11 and the second tube 16.
Is provided.

Hereinafter, the manufacturing method of the multi-lumen tube according to the second embodiment will be described mainly with reference to FIG. 4 while referring to differences from the first embodiment. (1) Forming a single tube Two cores having different outer diameters are prepared, and a tube 11 having a predetermined wall thickness and a predetermined outer diameter and a second tube 16 are respectively formed of high density PE. Is molded by extrusion molding. (2) Covering of Tube Cover Body The tube cover 11 and the second tube 16 are brought into contact with each other, and the tube cover body 17 is formed on their outer periphery by extrusion molding with low density PE. The wall thickness of the tube cover 17 is preferably as thin as possible from the viewpoint of reducing the outer diameter, but the tube 1
From the viewpoint of the close contact between the first and second tubes 16 and the embedding of the reinforcing body 14, 0.1 mm to 0.3 mm is suitable. Since the steps after the braiding of the reinforcing body 14 are the same as the manufacturing method of the first embodiment, the description thereof will be omitted. However, in the final process
0 and 21 are extracted.

A multi-lumen tube according to the first and second embodiments of the present invention constructed as described above, and a plurality of lumens having the dimensions of the first embodiment and a single extruded body such as low density PE. The comparison was made with the conventional example formed in 1. The data are shown in Table 1.

[Table 1] Among the items, the limit compressive strength is the pressure of 37 ° C contrast medium injected into the thicker lumen of the completed multi-lumen tube with a length of 80 cm. Indicates the pressure value when leaking. The inner hole closing radius is the radius of the circle when the flow of the contrast agent is stopped by flowing the contrast agent at 37 ° C into the narrow lumen and gradually making the circle smaller by making a circle with the multi-lumen tube. Show. For the accuracy of wall thickness, inner hole, and outer diameter, cut the completed tube 10 m into a length of 30 cm to 50 cm,
The variations in the thickness of the cut ends, the inner hole, and the outer diameter are shown. The smoothness of the inner hole is obtained by cutting open both ends of the cut tube and visually observing the surface state and touching the surface.

As can be seen from Table 1, the accuracy and performance of the multi-lumen tube of the present invention are improved as compared with the conventional example, and the performance of the second embodiment is more than double that of the conventional example.
The accuracy is improved from 2 times to 10 times or more.

That is, according to the multi-lumen tubes of the first and second embodiments described above, the following operational effects can be obtained. (1) Since at least one of the tubes forming each lumen is preliminarily formed as a single body, the dimensional accuracy in the length direction of each tube is made uniform, and variations are eliminated. (2) Since at least one of the lumens is formed of a tube, the surface of the lumen can be smoothed. (3) Since at least one of the lumens is formed of a tube and the tube jacket is provided on the outer circumference of the uniform tube and the uneven thickness tube, the overall rigidity and bending resistance can be improved. (4) Since at least one tube is formed as a single body, the dimensional accuracy in the length direction, in particular, the thickness of the boundary between the lumens is stable, and the pressure resistance of the boundary can be improved. It is possible to prevent the boundary from being damaged. (5) Since at least one tube is formed as a single body, the buckling resistance is improved and the lumen can be prevented from being blocked due to bending during use. (6) Since the reinforcement is provided, the buckling resistance and pressure resistance are further improved.

Further, according to the method for manufacturing a multi-lumen tube according to the first and second embodiments, the following operational effects can be obtained. (1) Since each tube is formed by using the core body, the smoothness of each lumen is improved, and the inner and outer diameters are stabilized and there is no variation. (2) Since the core is extracted in the final step, the extrusion pressure can be applied immediately below the coating when the tube covering is coated, and the adhesion of the tube covering can be improved. Therefore, the outer diameter can be stabilized. Also, the same effect can be provided in fixing the reinforcing body.

[0033]

As described above, according to the medical tube and the manufacturing method thereof of the present invention, since at least one inner hole is formed of a tube which is previously formed as a single body, dimensional accuracy in the length direction, In particular, the wall thickness of the boundary between the multiple inner holes is made uniform to improve pressure resistance and buckling resistance, and the surface of the inner hole is smoothed to prevent damage to the boundary between the multiple inner holes. Can be prevented.

[Brief description of drawings]

FIG. 1 is a sectional view showing a first embodiment of the present invention.

FIG. 2 is an explanatory view showing a manufacturing flow in the first embodiment.

FIG. 3 is a sectional view showing a second embodiment of the present invention.

FIG. 4 is an explanatory view showing a manufacturing flow in the second embodiment.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Multi-lumen tube 10 1st lumen 11 1st tube 12 2nd lumen 13 Unequal thickness tube 14 Reinforcement body 15 Tube jacket 16 2nd tube 17 Tube covering body 20,21
Core

Claims (7)

(57) [Claims] 1. A tube having a predetermined inner diameter and a predetermined wall thickness, and an eccentric wall tube in which at least one lumen having a predetermined inner diameter is formed in a wall thickness portion whose wall thickness continuously changes in the circumferential direction, A medical tube, wherein the tube is embedded in a large thickness portion of the thick portion of the uneven thickness tube. 2. The medical tube according to claim 1, wherein the uneven thickness tube has a reinforcing body and a tube jacket on the outer periphery thereof. 3. The medical tube according to claim 2, wherein the tube, the uneven thickness tube, and the tube jacket are fixed to each other in the length direction and integrated. 4. A medical tube comprising: a plurality of tubes each having a predetermined inner diameter and a predetermined wall thickness; and a tube covering body arranged in parallel with each other and covering the outer circumference thereof. 5. The medical tube according to claim 4, wherein the tube covering body has a reinforcing body and a tube jacket body on an outer periphery thereof. 6. A tube having a predetermined wall thickness is formed by extrusion molding on the outer circumference of a core body having a predetermined outer diameter, and at least one lumen having a predetermined inner diameter is provided on the outer circumference of the tube. An eccentric wall tube having a wall thickness portion in which the wall thickness is continuously changed is formed by extrusion molding, and a braided part formed by braiding a plurality of thin wires and a plurality of thin wires are arranged in parallel on the outer periphery of the eccentric wall tube. Non-braided portion is formed at a predetermined interval in the length direction, the thin wire of the non-braided portion is removed, the end of the thin wire of the braided portion is fixed to the uneven thickness tube, the uneven thickness tube of A tube jacket having a predetermined outer diameter is formed on the outer periphery by extrusion molding, the whole is cut at a substantially intermediate position of the non-braided portion, and a tensile force is applied to the core to extract the core. A method for producing a medical tube, comprising: 7. A plurality of tubes having a predetermined wall thickness are formed by extrusion molding on the outer circumference of each of a plurality of core bodies having a predetermined outer diameter, and the plurality of tubes are arranged in parallel and assembled together. , A tube covering is formed by extrusion molding so as to cover the outer circumference of the plurality of tubes, and a braided part in which a plurality of thin wires are braided on the outer circumference of the tube covering, and a non-braid in which a plurality of thin wires are arranged in parallel. Forming parts at a predetermined interval in the length direction, removing the thin wire of the non-braided portion, fixing the end of the thin wire of the braided portion to the tube covering, on the outer periphery of the tube covering. , A tube jacket having a predetermined outer diameter is formed by extrusion molding, the whole is cut at a substantially intermediate position of the non-braided portion, and a tensile force is applied to the core to extract the core. For medical use Method of manufacturing a cube.