JPH0759857A - Production of medical tube - Google Patents

Abstract

PURPOSE:To make it possible to produce the medical tube embedded with a reinforcing member by simple stages and to eliminate the possibility of peeling of the formed reinforcing member from the tube. CONSTITUTION:The reinforcing member 4 is a bar-shaped body of a small diameter and the outside surface thereof is coated with a coating layer 41 over approximately the entire part thereof. This coating layer 41 is formed of a material having compatibility with the constituting material of the tube. The reinforcing member 4 is wound spirally around the outside surface of an arbor 31 for forming a main lumen. The coating layer 41 is integrated to the constituting material of the tube by compatibilization when the material of the tube is molded on the outer side of the reinforcing member 4 and the arbor 31 and the arbor 31 is removed. The tube embedded with the reinforcing member 4 is thus obtd.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical tube having a reinforcing member, and in particular, it is used for general anesthesia during surgery, management of artificial respiration after surgery, assistance of autonomous respiration, and long-term breath management. The present invention relates to a method for manufacturing an inner tube.

[0002]

2. Description of the Related Art Conventionally, an endotracheal tube has been used for feeding a gas used for anesthesia or artificial respiration management into a living body. As shown in FIG. 10, an endotracheal tube 90
Is inserted into the trachea 93 of the patient 92, and air is injected using a syringe or the like through the check valve 91 at the rear of the pilot balloon 94 to expand the cuff 95 at the distal end. The trachea is fixed in the trachea 93 so as to be hermetically sealed, and is used by being connected to an anesthesia machine or an artificial respirator (not shown) via a connector 96 and a flexible tube 97 attached to the proximal end. There is also an endotracheal tube without a cuff 95, which is used for assisting autonomous breathing, for children, or for short-term use, and these are used without sealing the trachea.

[0003] These endotracheal tubes cause a bend (kink) when the patient 92 is inserted into the trachea 93, and may block the main lumen formed in the tube, which is a problem. In particular, when performing a surgery related to the brain or otolaryngology, the patient is often placed in a special posture such as lying down, and therefore, a kink of the endotracheal tube is likely to occur. Therefore, in order to obtain a reinforcing effect, a medical tube in which a spirally formed metal (stainless steel) wire is embedded has been developed (Japanese Patent Publication No. 60-1).
5339). And as a manufacturing method of such a medical tube, the following is mainly adopted.

[1] Dipping method A preformed tube is placed on a cored bar, or an inner tube serving as a core is formed on the cored bar by coating or dipping, and a metal wire rod is braided on the tube. Etc. by using a device such as spirally wound or arranging a metal wire rod formed in advance in a spiral shape, and then applying or dipping a liquid resin such as soft polyvinyl chloride or silicone, and heating the metal wire rod. To manufacture a buried medical tube.

[2] Continuous coating method An inner tube serving as a core is formed on a core wire made of plastic or metal by dipping or the like, and a metal wire rod is continuously spirally wound on the inner tube, and a resin is continuously applied. Then, the core wire is pulled out to manufacture a medical tube in which a metal wire is embedded.

[0006] Further, in manufacturing a medical tube having a side lumen formed therein, usually, a core metal for forming a side lumen is placed on a metal wire rod, and a resin or the like is coated on the metal wire rod, followed by forming the side lumen. This is done by removing the core metal.

[0007]

However, the above manufacturing method has the following drawbacks. [1] In any of the above cases, in order to embed a reinforcing metal wire in the tube, an inner tube is previously formed or arranged on the cored bar or core wire, and then the metal wire is arranged thereon. Therefore, the manufacturing process was complicated.

[2] A flexible tube is usually
It is composed of soft resin such as soft polyvinyl chloride and silicone, or elastomer, but since these are not compatible with the embedded metal wire, the adhesion between the tube and the reinforcing member is weak, so that the bending of the tube There is a risk that the metal wire may be peeled off or exposed.

[3] When the medical tube having the side lumen is formed as described above, the resin does not enter between the side lumen forming core bar and the metal wire, and the side lumen is electrically connected to the metal wire. May be formed. At this time, as described in [2] above, when the incompatible metal wire and the tube do not adhere to each other and a gap is formed between them, air for filling the cuff leaks from this gap. There was a risk of doing it.

An object of the present invention is to provide a method of manufacturing a medical tube, which can easily manufacture a medical tube in which an embedded reinforcing member does not separate from the tube.

[0011]

This object is achieved by the present invention described in (1) below. Also, the following (2)
Or (8) is preferable.

(1) A flexible tube body,
A method of manufacturing a medical tube, comprising: a main lumen formed along a longitudinal direction of the tube body; and a reinforcing member embedded in the tube body on an outer periphery of the main lumen, the method comprising: (A) the reinforcement. A first step of disposing the reinforcing member on the outer surface of the main-lumen-forming core bar with a coating layer made of a material compatible with the constituent material of the tube body being provided on substantially the entire outer surface of the member; ) A second step of forming the tube body outside the core metal and the reinforcing member, the method for producing a medical tube.

(2) In the step (B), an inflation lumen forming core metal is arranged on the outer surface of the reinforcing member, and the tube body is formed in this state to form the inflation lumen in the tube body. The method for producing a medical tube according to (1) above.

(3) Further, after the step (B),
The method for producing a medical tube according to the above (2), further comprising a step of installing an expandable / contractible expansion body whose inside communicates with one end of the inflation lumen.

(4) In the step (B), the method for producing a medical tube according to any one of the above (1) to (3), wherein the tip shape of the tube body is formed simultaneously with the formation of the outer layer.

(5) In the step (B), the main lumen-forming core bar has a shape curved in the longitudinal direction, and the tube body is formed outside the core bar and the reinforcing member to form the tube. The method for producing a medical tube according to any one of (1) to (4) above, wherein the main body has a shape curved in the longitudinal direction.

(6) The reinforcing member is formed by spirally winding a rod-shaped body, and the coating layer is provided on substantially the entire outer surface of the rod-shaped body. A method for producing a medical tube according to claim 2.

(7) The material forming the coating layer is the same as the material forming the tube body.
The method for producing a medical tube according to any one of (6).

(8) The method for manufacturing a medical tube according to any one of the above (1) to (7), wherein the reinforcing member is made of resin.

[0020]

According to the method of manufacturing a medical tube of the present invention, the reinforcing member is provided with a main lumen while a coating layer made of a material compatible with the constituent material of the tube body is provided on substantially the entire outer surface of the reinforcing member. Since it has a first step of arranging on the outer surface of the forming core metal and a second step of forming the tube body on the outer surfaces of the core metal and the reinforcing member, in order to have a structure in which the reinforcing member is embedded, Since it is not necessary to previously form the inner tube on the outer surface of the core metal for forming the main lumen, the medical tube can be manufactured by a simple process.

Further, even if the reinforcing member is made of a material such as a metal which is not compatible, the coating member surely melts and adheres to the tube body, so that the reinforcing member does not come off from the tube body. .

[0022]

BEST MODE FOR CARRYING OUT THE INVENTION The method for producing a medical tube of the present invention will be described in detail below with reference to the accompanying drawings. FIG. 1 is a perspective view showing a configuration example when the medical tube of the present invention is applied to an endotracheal tube, and FIG. 2 is an enlarged vertical sectional view of the endotracheal tube shown in FIG.

As shown in these figures, the endotracheal tube 1 is made of a soft resin or elastomer such as soft polyvinyl chloride, ethylene-vinyl acetate copolymer, polyurethane, silicone rubber, polyamide elastomer, soft fluororesin. Flexible tube body 2
And the main lumen 3 formed along its longitudinal direction
And an inflation lumen 5 that is provided in parallel with the main lumen 3 and extends to at least the vicinity of the tip of the tube body 2, and near the tip of the tube body 2 surrounds the outer peripheral surface of the tube body 2 in an annular shape. Whether the cuff 6 is provided so that one end of the inflation lumen 5 communicates with the inside, which is an expandable / contractible expander, and the other end of the inflation lumen 5 communicates via the inflation tube 8 It has a pilot balloon 9 for confirming whether or not.

The tube body 2 has a main lumen 3 penetrating from a base end 21 to a tip 22 for introducing an anesthetic gas, oxygen gas and the like. Tip 2 of tube body 2
The tip 2 is processed to have a smooth bevel shape for facilitating its insertion into the body, as shown in FIG. Further, at the base end 21 of the tube body 2,
A connector 12 is attached for connecting to the breathing circuit.

As shown in FIG. 2, a reinforcing member 4 is embedded in the tube wall forming the tube body 2 over the entire length thereof. In this configuration example, the reinforcing member 4 has a shape in which an elongated rod-shaped body is spirally wound along the tube wall of the tube body 2.

Further, as shown in FIG. 2, an inflation lumen 5 thinner than the main lumen 3 is provided on the tube wall forming the tube body 2 along the longitudinal direction of the tube body 2. The inflation lumen 5 is a lumen for feeding gas for cuff expansion into the cuff 6 described later, and through a side hole (communication hole) 11 formed on the outer surface of the tube wall of the tube body 2 in the cuff 6. hand,
It communicates with the internal space of the cuff 6. The inflation lumen 5 is closed near the tip 22 as shown in FIG. Further, as shown in FIG. 1, the inflation lumen 5 is provided with a flexible inflation tube 8 at a position near the base end 21 through a cutout portion 7 formed on the outer surface of the tube wall of the tube body 2. It is in communication.

At the rear end of the inflation tube 8, an expansion member for recognizing the degree of expansion and contraction of the cuff 6 is provided.
A retractable pilot balloon 9 is installed so as to communicate with the inflation tube 8. Further, on the rear end side of the pilot balloon 9, a check valve 10 having a function of allowing the gas to flow into the pilot balloon 9 but preventing the gas from flowing out from the inflated pilot balloon 9 is installed. There is. When a syringe or the like is connected to the check valve 10 and a gas such as air is pressed in, the gas is introduced into the pilot balloon 9, the inflation tube 8, the inflation lumen 5 and the side hole 11 into the cuff 6. The cuff 6 is fed and inflated (inflated).

In the method for producing a medical tube according to the present invention, a coating layer made of a material compatible with the constituent material of the tube body is provided on substantially the entire outer surface of the reinforcing member,
The method includes a first step of disposing the reinforcing member on the outer surface of the main lumen forming core metal, and a second step of forming a tube body on the outer surfaces of the core metal and the reinforcing member. FIG. 3 shows FIG.
4 to 7 are sectional views showing the reinforcing member 4 and the coating layer 41 formed on substantially the entire outer surface of the reinforcing member 4 shown in FIG.
It is drawing which shows an example of the process until it obtains the medical tube shown in FIG. 1 and FIG. 2 using the reinforcement member shown in FIG. Hereinafter, a method for manufacturing a medical tube according to the present invention will be described with reference to these drawings.

In the first step of the present invention, the reinforcing member 4 is made of a material having rigidity enough to obtain a sufficient reinforcing effect.
And a coating layer 41 made of a material compatible with the constituent material of the tube body 2 is formed on almost the entire outer surface of the reinforcement member 4, and the reinforcement member 4 having the coating layer 41 is formed. It is performed by arranging on the outer surface of the core metal 31 for forming the main lumen.

The constituent material of the reinforcing member 4 may be any material as long as it has rigidity enough to obtain a sufficient reinforcing effect. For example, a metal such as stainless steel, iron, titanium alloy, nickel alloy, cobalt alloy, or the like. Is mentioned. Among these, stainless steel and iron are particularly preferable because they can be easily formed and are inexpensive.

As the constituent material of the reinforcing member 4 other than metal, polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyolefins such as polyethylene (PE) and polypropylene (PP), and hard polychlorinated materials. Vinyl, polyamide,
Polyurethane, polyoxymethylene (POM), fluorine resin, ABS resin, phenol resin, polyimide resin,
A resin material such as epoxy resin, polysulfone, polyarylate, polymethylmethacrylate (PMMA), liquid crystal polyarylate, liquid crystal polyester carbonate, liquid crystal polyazomethylene, liquid crystal polymer such as liquid crystal polyesteramide, or a mixture thereof can also be used. . By constructing the reinforcing member 4 with such a resin material, it is possible to satisfactorily process the tip of the tube body 2 and impart a bend, and cut the tube body 2 to a desired length, as compared with the case of using a metal material. It can be carried out. Among them, especially
Polyethylene terephthalate, polybutylene terephthalate, polypropylene, rigid polyvinyl chloride, polyarylate, and polyamide are preferable because they have no toxicity, are easy to mold, and are inexpensive.

When the reinforcing member 4 is made of the above resin material, for example, an additive such as a hardening agent or a softening agent for adjusting strength (rigidity, hardness), a binder, etc. are added to the materials. Various additives such as a stabilizer, a colorant and the like may be blended. When the reinforcing member 4 is made of the resin material as described above, a filler made of an X-ray opaque material is mixed in the constituent material so that the tube body 2 has the contrast property. You can do it. Examples of X-ray opaque materials include gold, platinum, silver,
Examples thereof include metal powders of tungsten or alloys thereof, barium sulfate, bismuth oxide, bismuth subcarbonate, barium carbonate, and coupling compounds thereof.

When the reinforcing member 4 is a rod-shaped member having a small diameter as shown in FIGS. 2 and 3, the diameter of the reinforcing member 4 is 0.1 to 0.7 mm when the reinforcing member 4 is made of metal. degree,
In the case of resin, it is preferably 0.3 to 1.0 mm.
If it is less than the above range, the reinforcing effect is remarkably weakened, and if it exceeds the above range, the tube wall of the tube body 2 becomes too thick when the reinforcing member 4 is embedded, and the flexibility of the tube body 2 is reduced. May decrease.

Further, the cross-sectional shape of the reinforcing member 4 is not limited to the circular shape shown in the drawing, but may be any shape such as an elliptical shape, a semicircular shape, a semielliptic shape, a triangular shape, a polygonal shape such as a quadrangle, and an eyebrow shape. In addition, if the tube body 2 has a flat shape such as an elliptical shape, a semicircular shape, a semielliptical shape, a rectangular shape, or an eyebrow shape in the longitudinal direction, the thickness of the tube wall of the tube main body 2 can be made thinner. .

Any material can be used as the constituent material of the coating layer 41 as long as it is compatible with the constituent material of the tube body 2 described above. For example, when the tube body 2 is made of the above-mentioned soft polyvinyl chloride. As such a material, soft polyvinyl chloride, polyurethane or the like can be used. Further, in this case, if the coating layer 41 is thin enough not to impair the flexibility of the tube body 2, a hard material such as hard polyvinyl chloride can be used.

In particular, the constituent material of the coating layer 41 is preferably the same as the constituent material of the tube body 2.
By doing so, the coating layer 41 and the tube body 2 are surely melted and adhered to each other, and there is no fear that the reinforcing member 4 is separated from the tube body 2.

The coating layer 41 can be formed on the outer surface of the reinforcing member 4 by coating, dipping, extrusion molding or the like. When the reinforcing member 4 is made of the above resin material, the reinforcing member 4 and the coating layer 41 can be simultaneously formed by extrusion molding, two-color molding or the like. As described above, it is preferable to form the reinforcing member 4 and the coating layer 41 at the same time because the manufacturing process is further simplified.

The thickness of the coating layer 41 is 0.2 to 0.6 regardless of whether the reinforcing member 4 is made of metal or resin.
It is preferably about mm. Below this range, the reinforcing member 4 is arranged inside the tube body 2 in a significantly biased manner, and when the tube body 2 is bent, the tube body 2
May be exposed from the inner wall of the tube body, and if it exceeds this range, the cutting process becomes difficult, and when the reinforcing member 4 is embedded, the tube wall of the tube body 2 becomes too thick, and There is a risk that flexibility will be reduced.

In the constituent material of the coating layer 41,
Similar to the reinforcing member 4, it is also possible to mix the filler composed of the above-mentioned X-ray opaque material so as to give the tube body 2 a contrast property. Further, the filler may be mixed in both the reinforcing member 4 and the coating layer 41.

The reinforcing member 4 on which the coating layer 41 is formed is arranged on the core metal 31 as shown in FIG. 4, for example.
Is helically wound around the outer surface of the cored bar 31. In the illustrated example, the motor 32 to which the core metal 31 can be attached is operated to rotate the core metal 31 in the circumferential direction, while the reinforcing member 4 is fed from the braider 33, the core metal 31 is moved in the axial direction, The reinforcing member 4 is continuously wound in one direction from one end of the core metal 31 to the other end thereof.

In this case, the smaller the inclination angle of the reinforcing member 4 with respect to the axis of the cored bar 31, the closer the orientation direction of the reinforcing member 4 is to the axial direction of the tube body 2 formed as described later, and therefore the reinforcing member 4 And the rigidity of the tube body 2 (in particular, bending rigidity and torsional rigidity) is increased. Therefore, the inclination angle θ of the reinforcing member 4 with respect to the axis of the core metal 31 balances the reinforcing effect of the formed reinforcing member 4 and the flexibility such that the tube body 2 can be inserted into the trachea or the like well. Considering this, it is preferable that the angle is about 1 to 20 °, more preferably about 1 to 15 °, further preferably about 1 to 10 °, and the moving speed and rotation of the cored bar 31 in the axial direction are within such a range. It is preferable to set the speed.

Further, in the case of the endotracheal tube, in order to make the reinforcing effect constant, the pitch of the reinforcing member 4 is made constant throughout, and this pitch is about 1.0 to 5.0 mm.
Especially, it is set to be 1.5 to 3.5 mm. Therefore, so that the pitch of the reinforcing member 4 becomes the above value,
It is preferable to adjust the axial moving speed and / or rotating speed of the cored bar 31. Further, in the above description, the core metal 31 rotates and moves in the axial direction. However, when the reinforcing member 4 is wound around the core metal 31, the core metal 31 and the blader 33 rotate relatively and the relative distance is increased. It can be performed by moving the core metal in the axial direction. Therefore, for example, the core bar 31 rotates and the brader 33 moves in the core bar axial direction. The core bar 31 moves in the axial direction and the braider 33 rotates around the outer periphery of the core bar 31.
May be fixed, and the braider 33 may rotate around the outer periphery of the cored bar 31 and move in the axial direction of the cored bar 31, or a combination thereof. After winding the reinforcing member 4 on the core metal 31 in this manner, the surplus end portion of the reinforcing member 4 is cut.

The arrangement of the reinforcing member 4 on the outer surface of the cored bar 31 is not limited to the method of winding the reinforcing member 4 around the cored bar 31 as shown in the drawing. The reinforcing member 4 is formed in a shape of
It may be performed by covering it on 1.

Then, as shown in FIG. 5, the reinforcing member 4 is arranged apart from the cored bar 31 by an amount corresponding to the thickness of the coating layer 41. Therefore, if the tube main body 2 is formed on the core metal 31, the reinforcing member 4 can be formed without preliminarily disposing the tube inside the tube main body 2 on the core metal 31.
Is embedded inside the tube body 2.

In the second step of the present invention, the tube body 2 already described is placed on the cored bar 31 on which the reinforcing member 4 is arranged.
It is performed by forming the tube main body 2 using the constituent materials of.

To form the tube body 2, for example, as shown in FIG. 6, a dipping die 35 is filled with the dipping liquid 23 made of the material of the tube body 2 in advance, and the die 35 is formed. As shown in FIG. 7, the core metal 31 on which the reinforcing member 4 is arranged is inserted and the dipping liquid 23 is cured.

The tube body 2 is not limited to being formed on the outer surface of the reinforcing member 4 by dipping as described above. For example, as a constituent material of the tube body 2, a thermoplastic resin such as a soft vinyl chloride resin is used. Select
The above materials may be injection-molded on the outer surfaces of the reinforcing member 4 and the cored bar 31.

At the bottom of the mold 35 shown in FIGS. 6 and 7, there is formed a hole 351 through which the cored bar 31 is inserted without a gap, and one end of the cored bar 31 is fitted into this hole 351. Then, when the tube body 2 is formed, a main lumen that penetrates from the tip to the base end of the tube body 2 is formed.

The inner surface of the bottom of the mold 35 has a rounded and smoothly inclined shape corresponding to the above-mentioned tip shape (bevel shape). As a result, the above-mentioned tip shape (bevel shape) is formed at the same time when the tube body 2 is formed.
Can be obtained, and the manufacturing process can be simplified. The tip shape may be processed, for example, by forming the tube body 2 and then subjecting the tube body tip portion to a cutting treatment or a heat treatment.

Further, in the second step of the present invention, when manufacturing a medical tube having an inflation lumen, as shown in FIG. 7, an inflation lumen forming core metal 34 (hereinafter referred to as "core metal 34"). The core metal 3
It is preferable to form the tube main body 2 in a state in which the tube main body 2 is attached on the tube 1. Thereby, the inflation lumen 5 can be formed simultaneously with the formation of the tube body 2.

It is preferable that the cored bar 34 is arranged such that one of the ends of the cored bar 34, which is closer to the tip of the tube body 2, is retracted from the bottom surface of the mold 35. As a result, at the same time as the tube body 2 is formed, the inflation lumen 5 having the closed tip can be formed.

The inflation lumen 5 is formed by arranging the cored bar 34 so that its tip is positioned at the same position as or beyond the tip of the cored bar 31 and forms the tube body 2. May be formed by opening to the tip of the tube body 2, and the tip may be closed by heating or using a filling material. In the above manufacturing process, since the inflation lumen forming core metal 31 is arranged on the coating layer 41, the reinforcing member 4 and the inflation lumen 5 are not electrically connected to the reinforcing member 4, and the air filling the cuff is not provided. There is no risk of leakage from between the tube body 2 and the reinforcing member 4.

Further, as shown in the figure, if the reinforcing member 4 is arranged with the end portion of the cored bar 31 left for a predetermined length, a portion where the reinforcing member 4 is not embedded is formed at the end portion of the tube body 2. it can. Accordingly, even when the tip of the tube body 2 is heated to be processed into a desired shape after the tube body is formed, the reinforcing member 4 having higher rigidity and different melting point than the constituent material of the tube body 2 is not embedded, and thus the tip is processed. Can be done more easily. Further, since the distal end becomes more flexible, the tube body 2 can be inserted into the living body such as the trachea more easily.

After dipping in this way, the formed tube body 2 is taken out of the mold 35 and the core metal 31 is removed to form the main lumen and the tube body 2 in which the reinforcing member 4 is embedded. Is obtained. Then, the side hole 11 is further formed, the cuff 6, the inflation tube 8 and the pilot balloon 9 are attached, and the medical tube 1 having the configuration shown in FIG. 1 is manufactured. The cuff 6 is attached to the tube body 2 by covering the side hole 11 with a film formed in advance in a tubular shape and covering the outer periphery of the tube body 2, and by applying an adhesive to both ends of the outer periphery of the tube body 2. It is carried out by a method of fixing the material in a secret manner by adhering it with a solvent, or by fusing with heat, high frequency or the like.

The attachment of the inflation tube 8 to the inflation lumen 5 is carried out, for example, by inserting a preheated mandrel into the inflation lumen 5, and removing the mandrel and inserting the inflation tube 8 into the inflation lumen 5. Then, it is carried out by a method of fixing with a solvent or an adhesive. As the constituent material of the inflation tube 8, the same material as that of the tube body 2 can be used.

Then, a pilot balloon 9 and a check valve are attached to the rear end portion of the inflation tube 8 by a conventional method, and the connector 12 is fitted into the base end 21.
The medical tube shown in is manufactured. As the constituent material of the pilot balloon 9, for example, soft polyvinyl chloride,
Examples thereof include polyurethane, polyethylene, polypropylene, polyester, ester-vinyl acetate copolymer (EVA), silicone, and the like, or a mixture of any of these.

To obtain a medical tube without the cuff 6, the tube body 2 is formed in the same manner as above except that the inflation lumen 5 is not formed in the third step, and then the base end 21 of the tube body 2 is formed. Connector 1
Insert 2.

In the manufacture of the endotracheal tube, when the tube body 2 is to be bent, the cored bar 31 is curved in the axial direction, the reinforcing member 4 is arranged along the cored bar 31, and further, By forming the inside of the mold 35 into a curved shape similar to the core metal 31 and performing dipping, a curved shape can be imparted simultaneously with the formation of the tube main body 2.

Further, after the tube body 2 is formed as shown in the figure, the tube body 2 may be heat-treated so that the tube body 2 is bent. In this case, if the reinforcing member 4 is made of a resin material, the reinforcing member 4 is easily deformed by heating, so that it can be easily formed into a desired curved shape.

As described above, in the method for producing a medical tube of the present invention, the medical tube is produced one by one by sequentially performing the above-mentioned first step and second step.
It can be simply and efficiently manufactured. In the present invention, the coating layer 41 may be disposed on substantially the entire outer surface of the reinforcing member 4, and a part of the outer surface of the reinforcing member 4, for example, the core when the reinforcing member 4 is disposed on the cored bar 31. One of the parts excluding the part facing the gold 31 or core 35
Alternatively, the coating layer 41 may not be formed in two or more places.

Further, although the reinforcing member 4 is shown in its original shape in FIG. 2, when the reinforcing member 4 is made of resin, the reinforcing member 4 is actually formed over the entire surface thereof as the outer layer 24 is formed. May be slightly deformed, melted, or fused with the constituent material of the tube body 2 itself.

In the present invention, the reinforcing member is not limited to the above spiral shape. FIG. 8 is a perspective view showing another configuration example of the reinforcing member. The reinforcing member 36 shown in the figure has a shape in which a plurality of rings 37 are connected by a connecting rod 38.
Material of the reinforcing member 36, cross-sectional shape, ring 36
The formation pitch and the like are the same as those of the reinforcing member 4 described above.

As shown in FIG. 9, a covering layer 361 is provided on the outer side of the reinforcing member 36 over substantially the entire outer surface thereof. The constituent material and thickness of the coating layer 361 are the same as those of the coating layer 41 described above.

Such a reinforcing member 36 and a coating layer 36
For example, the reinforcing member 4 can be formed in advance by integral molding or the like, and the constituent material of the coating layer 361 can be formed on the outer surface thereof by dipping, coating, extrusion molding, or the like. When the constituent material of the reinforcing member 4 is the resin material described above, the reinforcing member 36 and the covering layer 361 can be simultaneously formed by, for example, two-color molding or insert molding.

Then, the reinforcing member 3 thus formed
A main lumen forming core bar (not shown) having a diameter substantially the same as the inner diameter is inserted inside 6 and the tube body 2 is formed in this state as in the case of the reinforcing member 4. As a result, the tube body 2 in which the reinforcing member 36 is embedded is obtained. The reinforcing member 36 has a coating layer 361.
Therefore, as in the case of the reinforcing member 4, it is not necessary to previously arrange the tube inside the tube body 2 on the core metal for forming the main lumen.

Even when the tube body 2 having the inflation lumen 5 is formed, an inflation lumen forming core metal (not shown) is arranged outside the reinforcing portion 36 as in the above example. The inflation lumen 5 can be formed by performing the formation. Even in this case, since the inflation lumen forming cored bar is arranged on the covering layer 361, the reinforcing member 36 and the inflation lumen 5 are not electrically connected to the reinforcing member 36, and the air that fills the cuff is not connected to the tube body 2. There is no risk of leakage from between the reinforcing member 36.

On the outer surface of the main lumen core metal 31, a lubricant (release agent) such as wax, silicone, or grease is used on the outer surface of the core metal to facilitate insertion into the reinforcing member 36. It can also be applied to.

Further, in the tube main body 2 in which the reinforcing member 36 is embedded, when the tube main body 2 is bent, it is preferable that the side where the connecting rod 37 is present is the inside. Further, there may be two or more connecting rods 37.

The method for producing a medical tube according to the present invention has been described above by taking an endotracheal tube as an example, but the present invention is not limited to this. For example, one having an expandable body such as a balloon catheter or a contrast catheter. Any medical tube may be used as long as it is a medical tube including a blood vessel catheter such as a guiding catheter and a blood removal catheter for open heart surgery.

[0070]

EXAMPLES Next, specific examples of the present invention will be described. (Example 1) A rod-shaped body (diameter 1.3 m) in which the outer surface of a polyester filament 0.7 mm in diameter (bending rigidity 600 gf) is coated with soft polyvinyl chloride 0.3 mm thick
m) was produced by continuously coating the outer surface of the above filament with soft polyvinyl chloride, and this rod was spirally wound on a round bar-shaped stainless steel core bar having a diameter of 8.0 mm and a length of 350 mm as shown in FIG. It was wound into a shape and cut at the end. The spiral pitch was 3.0 mm and the inclination angle was 8 °.

Next, on the outer surface of this rod-shaped body, a diameter of 0.6
A mm wire was placed so as to be parallel to the stainless steel core. Then, the mold having the structure shown in FIG. 6 (inner diameter 12.0
mm, internal space length 350 mm), soft polyvinyl chloride paste resin solution (compounding 100 parts by weight of paste resin, 70 parts by weight of DOP which is a plasticizer, and 7 parts by weight of epoxidized vegetable oil as a stabilizer) Was filled, and the core metal was inserted into the mold, immersed in the paste resin solution, and cured at 170 ° C. for 30 minutes.

After removing the mold, the wire was pulled out to form an inflation lumen, and the stainless cored bar was removed to obtain a tube body having the structure shown in FIG. The size of the tube body was 12.0 mm in outer diameter, 8.0 mm in inner diameter (wall thickness of 2.0 mm), and 400 mm in total length, and a reinforcing member made of polyester was embedded over the entire length. Further, by using the above-mentioned mold, the tip edge portion of the obtained tube body has a rounded shape (R shape), and the tip end side of the inflation lumen is closed.

The soft polyvinyl chloride coated on the polyester filament was completely compatible with and integrated with the hardened soft vinyl chloride on the outside thereof. No exposure of the reinforcing member to the inside or outside of the tube body was observed.

A communication hole with a cuff was provided in the vicinity of the tip of the obtained inflation lumen, and an inflation tube attachment hole (notch) was formed at the base end. A check valve was provided at the base end of the mounting hole, and an inflation tube made of soft polyvinyl chloride having a pilot balloon made of polyvinyl chloride was inserted in the middle and airtightly fixed by an adhesive. On the other hand, the base end of the tube body was heated to soften it and the connector was fitted.

Further, a polyvinyl chloride cuff (film thickness: 0.2 mm) was produced in the mold by heat and pressure molding, and this cuff was covered near the tip of the tube body so as to cover the communication hole, and the cuff was removed. Both ends were heat-sealed and airtightly fixed to the tube body to obtain the endotracheal tube shown in FIG.

In this endotracheal tube, when air was pressed into the cuff through a check valve and an inflation lumen using a syringe, the cuff could be expanded well. At this time, no air leak was observed.

Example 2 An endotracheal tube shown in FIG. 1 was obtained in the same manner as in Example 1 except that polyurethane was used as the resin for coating the outer surface of the polyester filament.

The polyurethane coated on the polyester filament was completely compatible with and integrated with the cured soft vinyl chloride on the outside thereof. No exposure of the reinforcing member to the inside or outside of the tube body was observed.

When air was pressed into the cuff in the same manner as in Example 1, the cuff could be expanded well. At this time, no air leak was observed.

Example 3 An endotracheal tube shown in FIG. 1 was obtained in the same manner as in Example 1 except that 10% by weight of barium sulfate as an X-ray contrast agent was blended in the polyester filament.

When this tube was inserted into the trachea and observed under fluoroscopy, the position of the tube in the trachea could be satisfactorily recognized from the X-ray contrast image of the reinforcing member 4.

(Example 4) A rod-shaped body (diameter 1.1 mm) in which a soft polyvinyl chloride having a thickness of 0.3 mm was coated on the outer surface of a stainless steel filament having a diameter of 0.5 mm was attached to the outer surface of the filament. An endotracheal tube shown in FIG. 1 was obtained in the same manner as in Example 1 except that it was produced by continuously coating soft polyvinyl chloride.

The soft polyvinyl chloride coated on the stainless steel filament was completely compatible with and integrated with the hardened soft vinyl chloride on the outside thereof. No exposure of the reinforcing member to the inside or outside of the tube body was observed.

When air was pressed into the cuff in the same manner as in Example 1, the cuff could be expanded well. At this time, no air leak was observed.

[0085]

As described above, according to the method of manufacturing a medical tube of the present invention, a flexible tube main body, a main lumen embedded along the longitudinal direction of the tube main body, and the main lumen. A method for manufacturing a medical tube having a reinforcing member embedded in the tube body on the outer periphery of (A) a material having compatibility with the constituent material of the tube body on substantially the entire outer surface of the reinforcing member. A step of disposing the reinforcing member on the outer surface of the core metal for forming the main lumen in the state where the coating layer is formed, and (B) forming the tube body outside the core metal and the reinforcing member. Since it has a step, the step of previously disposing the tube on the core metal for forming the main lumen is unnecessary, and the medical tube in which the reinforcing member is embedded is extremely simplified. It can be produced by a degree.

Even when the reinforcing member is made of an incompatible material such as a metal, the coating layer surely melts and adheres to the tube body, and thus is obtained by the manufacturing method of the present invention. In the tube, the reinforcing member does not separate from the tube body.

[Brief description of drawings]

FIG. 1 is a perspective view showing a configuration example of an endotracheal tube.

FIG. 2 is an enlarged vertical sectional view of the endotracheal tube shown in FIG.

FIG. 3 is a cross-sectional view showing a configuration example of a reinforcing member and a coating layer.

FIG. 4 is a schematic view showing how a reinforcing member is spirally wound around a core bar for forming a main lumen.

FIG. 5 is a partial cross-sectional view showing a state in which a reinforcing member is arranged on a core metal for forming a main lumen.

FIG. 6 is a cross-sectional view showing a configuration example of a mold for forming a tube body.

FIG. 7 is a partial cross-sectional view showing how to form a tube body using the mold shown in FIG.

FIG. 8 is a perspective view showing another configuration example of a reinforcing member.

9 is a cross-sectional view showing a configuration example in which a coating layer is provided on the outer surface of the reinforcing member shown in FIG.

FIG. 10 is a schematic view showing a use state of an endotracheal tube.

[Explanation of symbols]

 1 Endotracheal tube 2 Tube body 3 Main lumen 4 Reinforcing member 41 Covering layer 31 Main lumen forming core bar 36 Reinforcing member 361 Covering layer

Claims (1)

[Claims] 1. A medical device comprising a flexible tube body, a main lumen formed along the longitudinal direction of the tube body, and a reinforcing member embedded in the tube body on the outer periphery of the main lumen. A method for manufacturing a main tube, comprising: (A) forming a main lumen of the reinforcing member with a coating layer made of a material compatible with a constituent material of the tube main body provided on substantially the entire outer surface of the reinforcing member. A method of manufacturing a medical tube, comprising: a first step of arranging on the outer surface of a cored bar; and (B) a second step of forming the tube body outside the cored bar and the reinforcing member.